By Gary Evans, Executive Editor
Setting the stage for CMS regulations requiring antibiotic stewardship programs in hospitals nationwide, President Obama has issued a sweeping executive order to reduce the threat of multidrug resistant bacteria to the nation’s endangered formulary.
Eventual regulatory action on antibiotic stewardship by the Centers for Medicare & Medicaid Services (CMS) was already seen by some as a foregone conclusion, but the executive order was accompanied by an urgently worded presidential advisory panel report that calls for initial federal regulations to be in place by the end of 2017.
“I would recommend that health care institutions across the country start preparing — [discussing] what would need to happen should this occur?” says John Lynch, MD, MPH, head of the antimicrobial stewardship program and co-director of infection control at Harborview Medical Center in Seattle, WA.
“I suspect like infection control — which has a combination of both state and federal requirements for reporting — we may see something similar happen across the United States [for antibiotic stewardship],” says Lynch, a member of the Infectious Diseases Society of America (IDSA).
California — the only state to have an antibiotic stewardship law in effect — recently revised the general requirements passed in 2006 to a much more specific mandate for state hospitals effective July 2015. (See related story, p. 111) Other states are expected to follow California’s lead, meaning we may see a patchwork of state laws and federal regulation similar to the explosion of health care associated infection (HAI) reporting laws that started a decade ago.
“Hospitals and other settings need to prepare for this sort of combined reporting requirements by their states and the federal government,” Lynch advised.
At the federal level, the Sept. 18, 2014 executive order states that by the end of calendar year 2016, the Department of Health and Human Services (HHS) must review existing regulations “and propose new regulations or other actions, as appropriate, that require hospitals and other inpatient healthcare delivery facilities to implement robust antibiotic stewardship programs that adhere to best practices, such as those identified by the Centers for Disease Control and Prevention.”1 The executive order calls for formation of a multi-agency task force, which must submit a five-year national action plan by Feb. 15, 2015 that includes “goals, milestones, and metrics for measuring progress, as well as associated timelines for implementation.”
In addition to pushing for new drug development and reaching out to international partners facing a similar, global problem, the executive order calls for a more aggressive role in “actively identifying and responding to antibiotic-resistant outbreaks; preventing outbreaks and transmission of antibiotic-resistant infections in healthcare, community, and agricultural settings through early detection and tracking of resistant organisms; and identifying and evaluating additional strategies in the healthcare and community settings for the effective prevention and control of antibiotic-resistant infections.”
The order was accompanied by a report by the President’s Council of Advisors on Science and Technology (PCAST), which included more specific details of what should be included in a CMS regulation on antibiotic stewardship.2 (See related story, p. 114.)
Now entering the post-antibiotic era
As infection preventionists are well aware, there are now infections resistant to all available antibiotics, as vanishing drug efficacy and a “post-antibiotic” era are no longer theoretical threats. The CDC has repeatedly warned that we are entering a post-antibiotic era, particularly as gram negative bacteria like carbapenem-resistant Enterobacteriaceae (CRE), exchange resistance plasmids and enzymes that can render most antibiotics useless. At this year’s conference of the Association for Professionals in Infection Control and Epidemiology (APIC) in Anaheim there were CRE infections described that were even resistant to colistin, a last-choice antibiotic that has maintained its efficacy primarily because it’s typically worse for the patient than anything they are infected with.
Stewardship programs are needed to optimize the use of antibiotics — “not just reduce the total volume used — in order to maximize their benefits to patients, while minimizing both the rise of antibiotic resistance as well as adverse effects to patients from unnecessary antibiotic therapy,” the presidential advisory report stated. “Stewardship involves identifying the microbe responsible for disease; selecting the appropriate antibiotic, dosing, route, and duration of antibiotic therapy; and discontinuing antibiotics when they are no longer needed.”
Some 2 million people are infected with antibiotic-resistant pathogens annually, resulting in some 23,000 deaths, the CDC estimates. Drug stewardship has been shown to reduce the burden of resistant organisms in facilities and improve patient safety, but the CDC estimates that only about half of U.S. hospitals have implemented such programs. Common barriers to implementation include higher priority clinical initiatives, staffing constraints and insufficient funding, the PCAST report found. The result is that about half of antibiotics prescribed are completely unnecessary, and the problem is compounded as the drugs kill off susceptible bacteria and select out resistant strains.
APIC reviewing ex order, Pres report for comment
While emphasizing the importance of antibiotic stewardship, APIC would like to review the ultimate CMS regulation that comes out of this process before issuing a blanket endorsement.
“We would have to see what the language in the regulation is before we would say anything about it — that is our practice. But in general, we support antibiotic stewardship,” says Annemarie Flood, RN, BSN, CIC, chair of the APIC Public Policy Committee.
The committee is currently reviewing the executive order and the PCAST report and is expected to issue a formal comment in the near future. Currently, APIC is reaching out to patients with an educational campaign, trying to tamp down the expectation and demand for unneeded antibiotics. In addition, APIC selected antibiotic stewardship as the theme of infection control week activities this October.
“We realize that antibiotics are becoming a diminishing resource,” Flood says. “We agree that antibiotic stewardship is one of the tools that we need to utilize to preserve that resource. Infection preventionists are really in a unique position to reach out to health care workers and the public as well to teach them about antibiotic stewardship.”
However, antibiotic stewardship is only one element of preventing multidrug resistant infections, she noted. Of course, IPs face the constant challenge of improving compliance with hand hygiene, barrier precautions and other critical elements that are dependent on the vagaries of human behavior.
As proposed by the presidential advisory committee, a CMS regulation would essentially codify recent CDC recommendations on antibiotic stewardship.3 (See related story, p. 114) In addition, PCAST recommended that a CMS regulation require health care facilities to report data to the Antimicrobial Use and Resistance (AUR) module in the CDC’s National Healthcare Safety Network (NHSN). This relatively new NHSN module currently gives facilities the option to report antimicrobial usage of various classes of antibiotics and/or antimicrobial resistant infections from a host of gram negatives to MRSA.
“The [NHSN module] is really designed to gather these data on a national level so that hospitals can benchmark themselves against other similar facilities,” says Daniel Diekema, MD, president of the Society for Healthcare Epidemiology of America (SHEA).
The presidential advisory panel recommended CMS report the NHSN data on its Hospital Compare quality indicator site and eventually add stewardship to its value based purchasing requirements. Lynch says requiring reporting of antibiotic data to the NSHN would “change the prioritization of antibiotic usage in health care without a doubt.”
Both SHEA and IDSA originally called for a federal CMS regulation to preserve antibiotic efficacy in a 2012 position paper.4 The associations have continued to champion the issue and lobby for regulations.
“SHEA has been pushing for this for quite a while now,” Diekema says. “The incentives would really drive hospitals to establish serious antibiotic stewardship programs.”
Will data burden be an issue for IPs?
In calling for a CMS regulation on stewardship, the PCAST report specifically cited infection prevention as a field dramatically empowered by CMS Conditions of Participation (CoPs). “The infection©\control CoP changed hospital practices from being reactive (with measures deployed after the outbreak of infections) to proactive (with successful large©\scale interventions that prevent serious health care©\associated infections such as central line©\associated bloodstream infections, surgical site infections, and the transmission of resistant pathogens from patient to patient),” the advisory report states.
Still, there have been longstanding concerns in the infection prevention community about the burden of more and more data collection on inundated IPs. On the other hand, there is also the expectation that automated surveillance technologies, electronic records and improved links with clinical laboratories could make any new regulatory requirements on antibiotic resistance more manageable. However, with infection preventionists pushing to get out on the ward floors and even to the patient bedside, a proposed CMS regulation that would relegate them back into their silos as data collectors may not sit well with the profession. A key 2012 paper co-authored by infection preventionists called for IPs and hospital epidemiologists to have collaborative roles on antibiotic stewardship programs.5
“Since a lot of antimicrobial stewardship has to do with asking physicians to change what they are doing, they must have a physician collaborator,” says Sara Cosgrove, MD, lead-author of the paper and director of antibiotic stewardship at Johns Hopkins Hospital in Baltimore. “In the stewardship world we have seen infection control make great strides and some of that is related to being a person who drives change and leads interventions — not the role 20 years ago of doing more surveillance.”
Lynch concurs, saying infection prevention is indispensable to antibiotic stewardship.
“I run infection control and antibiotic stewardship here at my hospital and I think you will find that kind of combination is going on in a lot of places,” he says. “A lot of people who work in infection prevention work in antibiotic stewardship in our program. I think philosophically you can’t really separate antibiotic stewardship from infection control. They are complementary [and] need to work together and integrate going forward. Infection preventionists are the experts in NHSN surveillance and data uploading. That’s a skill set that antibiotic stewardship teams don’t currently have.”
Physician and pharmacists are expected to lead antibiotic stewardship programs, but the CDC report on which the CMS regulation will apparently be based notes that, “infection preventionists and hospital epidemiologists coordinate facility-wide monitoring and prevention of healthcare-associated infections and can readily bring their skills to auditing, analyzing and reporting data. They can also assist with monitoring and reporting of resistance and CDI trends, educating staff on the importance of appropriate antibiotic use, and implementing strategies to optimize the use of antibiotics.”5
Unknowns, unintended consequences
There are other concerns and caveats about how all of this may play out, with some questioning the breadth of federal agencies tapped to participate in the process. For example, the presidential order summoned agencies of all stripes to join a new task force on this issue, including Homeland Security and the Department of Defense.
“Some people are concerned whether there is enough direction,” says Diekema. “I think some people were wanting there be identified a single responsible party to move this forward so it doesn’t kind of get lost in the bureaucracy. Time will tell how much of this report and how many recommendations from the President’s Council are actually going to come to fruition.”
While the CDC and PCAST certainly outline and inform the future of stewardship programs, ultimately some specific items will have to be boiled down to a checklist that can be used by a CMS surveyor.
“If it becomes a CoP there is going to have to be a way to measure it — a checklist or something,” he says. “That’s how the [CMS] works.”
And work by government agencies can proceed at a ponderous pace, as exampled by the CMS’ ambitious draft survey for inspecting infection control programs in hospitals. The draft checklist — which looks at everything from hand hygiene to the surgical suite — was originally projected for finalization in 2013. Now the latest word is that it will be issued in fiscal year 2015, which began Oct 1. Interestingly, the draft CMS infection control survey included some non-enforceable provisions on antibiotic stewardship, showing that the issue is on the agency’s radar but apparently can’t be enforced without new regulation. In any case any resulting CMS regulation must have specificity and rigor if it truly is going to be effective in curtailing the misuse and overuse of antibiotics.
¡®It’s easy to say you have a stewardship program because you produce antibiograms and have named a PharmD as the head of stewardship,” Diekema says. “That doesn’t necessarily mean you’re doing anything to improve antimicrobial utilization or measure with the appropriate metrics. I think that one of the things that sometimes gets lost in the larger picture is that we still don’t know what the best ways are of doing stewardship. What are the appropriate things to be measuring? What style or approach to stewardship is most effective? How do you measure that effectiveness? What are the unintended consequences of certain approaches to stewardship?”
In that regard, the PCAST report calls for more research into such questions, but the problem has reached such a crisis point that would it seem far too urgent to brook inordinate delay. That point was driven home when HIC recently asked a CDC stewardship expert whether the latest iteration of multidrug resistant bacteria — in this case a virulent form of KPC that was also impervious to antibiotic treatment — was a proverbial “game changer.”
“I think the game has already changed,” said Arjun Srinivasan, MD, a medical epidemiologist in the CDC’s Division of Healthcare Quality Promotion.
- President Barack Obama. Executive Order — Combating Antibiotic-Resistant Bacteria. Sept. 18, 2014. Available at: http://1.usa.gov/ZrXYwP
- President’s Council of Advisors on Science and Technology. Report to the President on Combating Antibiotic Resistance. September 2014. Available at: http://1.usa.gov/1qhDgF6
- Centers for Disease Control and Prevention. Core Elements of Hospital Antibiotic Stewardship Programs. 2014. Available at: http://1.usa.gov/1l236QG
- Policy Statement on Antimicrobial Stewardship by the Society for Healthcare Epidemiology of America (SHEA), the Infectious Diseases Society of America (IDSA), and the Pediatric Infectious Diseases Society (PIDS) Infect Con Hosp Epi, 2012;(Special Topic Issue: Antimicrobial Stewardship) 33:322-327.
- Moody J, Cosgrove SE, Olmsted R, et al. Antimicrobial stewardship: A collaborative partnership between infection preventionists and healthcare epidemiologists. AJIC 2012;40:94-95