CDC looking to CMS to add teeth’ to new antibiotic stewardship guidelines
Threat of untreatable infections could prompt regulatory action
By Gary Evans, Executive Editor
The Centers for Disease Control and Prevention is crafting antibiotic stewardship guidelines with an eye toward future enforcement by the Centers for Medicare and Medicaid Services, Hospital Infection Control & Prevention has learned.
With the rapid rise of antibiotic-resistant bacteria and the threat of untreatable infections, stewardship programs to carefully monitor and control drug use have become a top public health priority. Infectious disease groups like the IDSA and SHEA have previously called for CMS regulations aligning appropriate antibiotic use with financial incentives and penalties.1 The CDC is now adding its considerable clout to the issue, drafting guidelines to help hospitals preserve vanishing drug efficacy as the health care system nears a "post-antibiotic" era.
"I think [CMS regulation] would advance this effort like nothing else," Arjun Srinivasan, MD, a medical epidemiologist in the CDC’s Division of Healthcare Quality Promotion, said at a Nov. 6 meeting of the Healthcare Infection Control Practices Advisory Committee (HICPAC). "In order to do that there does need to be this type of supporting information — some guidance for health care facilities. We view a lot of this [CDC proposal] as being very supportive and an important step in moving in that direction. One of the motivations for doing this is to try to support some of the effort that I think the CMS is interested in undertaking. They clearly recognize the importance of stewardship."
As proposed, the CDC antibiotic stewardship guidelines would include "required elements" such as monitoring antibiotic use.
"We think this is critical," Srinivasan said. "You can’t improve something if you don’t have a way to measure it."
Other required elements include implementing policies and interventions to improve antimicrobial use, including using antibiograms to show specific bug-drug resistance patterns and developing order sets and clinical pathways with "embedded" treatment recommendations. Another common sense recommendation is for clinicians to take an antibiotic "timeout" after two or three days of treatment to reassess the situation.
"Antibiotics are often started in the absence of all the clinical information that you would like to have," Srinivasan said. "After a couple of days, culture results, imaging results, patient response are available and that is a good time to reassess."
Policies calling for drug restrictions and prior authorization are also on the table, as is a broader post-prescription review for streamlining and de-escalation.
"This would not necessarily be a timeout done by the provider, but a timeout done by [the system] to hopefully have a broader understanding of antibiotic use," he said.
CMS could codify recommendations
The potential involvement of CMS came up after a discussion that included a broad consensus among HICPAC members emphasizing that mere CDC recommendations to adopt stewardship programs would have little effect.
"If we are really talking about antibiotic resistance as being a public health emergency that threatens our way of caring for patients, then we are setting the bar way too low with this," said HIPAC member Mark E. Rupp, MD, director of epidemiology at Nebraska Medical Center in Omaha. "I would really encourage you to put some teeth into this."
In that regard, the CMS is increasingly seen as a way to codify traditional voluntary guidelines with pay-for-performance incentives. Moreover, the CMS has included an assessment of antibiotic stewardship programs in a pilot survey it is developing to inspect hospital infection control programs. Though conceding that stewardship requirements go beyond the scope of its current regulations, it is telling that the CMS is already advising inspectors to ask about antibiotic stewardship efforts when visiting hospitals.
In any case, a cursory checklist without a clear requirement to designate resources to the effort could lead hospitals to simply designate a physician that would essentially be the director of stewardship in name only, HICPAC members warned.
"If you don’t distinguish that we won’t have the weight’ to take to administration and say we need to build real attention to this problem," said Susan Huang, MD, MPH, FIDSA, medical director of epidemiology and infection prevention at University of California Irvine Healthcare in Orange, CA. "If you don’t have something that talks about a program and what it entails they won’t invest in it. A part of what we struggle with all the time is can you get your administration to agree that you need a-quarter FTE, much less a full FTE that you probably really need?"
Several other HICPAC members concurred that a proposed antibiotic stewardship program recommendation would have to include the need for program support at the institution level.
"You really need to put this more in the context of support," said Tom Talbot, MD, chief hospital epidemiologist at the Vanderbilt University School of Medicine in Nashville. "I think you could say devoted resources,’ whatever those are — personnel support, some money for IT. That puts a little more skin in the game. This kind of support you could argue is in line with institutional incentives for quality goals."
Analogous to infection prevention
The gravity of the present situation should ensure traction on the issue, one that is all too familiar to IPs. The overuse and misuse of antibiotics across the health care spectrum is driving selective pressure for the emergence of drug resistant bacteria. A recent CDC report on the pressing challenge concluded that "up to half of antibiotic use in humans and much of antibiotic use in animals is unnecessary and inappropriate."2
Administering unneeded antibiotics has patient consequences, including the development of Clostridium difficile infections after carpet bombing the gut with some broad-spectrum agent. (See related story, p. 138.) Thus the need for stewardship programs, which are mentioned in various CDC guidelines and statements but not as a definitive, stand-alone document.
"We think it is important for CDC to have a formal and more comprehensive recommendation on antibiotic stewardship," Srinivasan said. "Stewardship is considered a core strategy."
In that sense it is a strategy that should be embraced as a responsibility by all health care providers, he added. The idea is analogous to the way infection control has evolved from the bailiwick of a lone practitioner to become part of the responsibility of all health care workers, Srinivasan noted.
"I thought about this [in terms of] of infection control, which for a long time was perceived as a job of the IP that was either done for you or to you," he said. "Now, the issue is infection control is your job’ — as an internist, an intensivist, a gastroenterologist. The IP and health care epidemiologist are there to help you — give you tools and train you. But it is not their job to do it. We need to have exactly that same shift here [for antibiotic stewardship]."
And while infection preventionists were cited as having important supporting roles in such programs, the CDC’s primary focus at the outset is to get physicians and pharmacists on board. A basic hospital checklist the CDC is creating opens with the question: "Does this facility have a physician leader identified to optimize antibiotic use?" (See related story p. 135.)
"There has to be a person, a physician who is assigned the responsibility — it can’t be diffused to a committee," Srinivasan said.
HICPAC member Ruth Carrico, PhD, RN, CIC, told HIC that "certainly the IP is going to be critical to making sure all of this happens, but what they are saying is the first tier is to get the leadership for the stewardship program. Then we can start looking at what are we finding in terms of our monitoring and use. Then, who are the key partners? I think it will be kind of a trickle down’ thing because really every nurse has a role in antimicrobial stewardship. They need to make sure that a drug is being given and [know] why it is being given. Every person has a role as these programs are developed."
As with so many aspects of infection prevention, there appears to be a risk of lax or non-compliance if the hospital policy is perceived as a low priority. Thus the interest in CMS involvement, though it comes with the warts-and-all concession that some hospitals are simply not going to adopt a meaningful stewardship program without a regulatory requirement.
"The key is going to be to somehow have a link between what we have in these guiding documents and what we have in terms of regulation," said Carrico, a former IP who is now an associate professor at the School of Public Health and Information Sciences at the University of Louisville, KY. "We’re just not willingly doing what we know needs to be done. We keep putting ourselves in the position of somebody having to tell us to do it or it’s going to affect our payment."
Though HICPAC is not expected to formally sign off on the guidelines and open its typically extensive review process, the CDC sought committee input on the idea of creating a how-to guideline that would serve the dual purpose of emphasizing the importance of antibiotic stewardship across the health care continuum.
There was much discussion of creating a document that could provide guidance to both small and larger facilities, providing a baseline for all while highlighting stewardship activities that go beyond a minimum level program.
"The fundamental recommendation will be that all hospitals take action to improve antibiotic use by implementing an antimicrobial stewardship program," Srinivasan said. "Our vision is to really link each of these elements with very specific guidance, tools, success stories and implementation stories."
Indeed, the document may have as much or more value for internal use, particularly if the CDC details exactly how to address identified gaps at a given facility, said HICPAC member Sanjay Saint, MD, director of the University of Michigan Patient Safety Enhancement Program in Ann Arbor.
"Right now we are talking about this as an external document that someone [uses] to kind of evaluate the hospital, but I see the real value as an internal document ideally on a website where the hospitalist or the chief of medicine can look at this and answer does your facility have a physician that you have identified?" he said. "If they answer no’ then you would also give them guidance about how to identify that physician leader. Who would be appropriate, how much time should be allotted? I think that will help them implement antimicrobial stewardship programs."
- 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.
- Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States, 2013: http://1.usa.gov/15yIo29