Q&A: What You Need to Know About CMS’ Antimicrobial Stewardship Rule

By John Palmer, PSQH

Editor’s note: The following is a Q&A with two experts at Chicago-based Lumere, a healthcare think tank focused on helping health systems eliminate medical errors and cut unnecessary costs. Gina Thomas, BSN, RN, is chief nursing officer, and Samantha Bastow, PharmD, is pharmacy solution advisor.

On September 26, 2019, the Centers for Medicare and Medicaid Services (CMS) released revised Conditions of Participation for hospitals and critical access hospitals that require the development and implementation of antimicrobial stewardship programs (ASP) to help reduce inappropriate antibiotic use and antimicrobial resistance. The rule, first proposed by CMS in 2016, also finalized requirements for nursing facilities to have a stewardship program.

The Joint Commission also requires acute care hospitals, critical access hospitals, nursing homes, and ambulatory care centers to have an antibiotic stewardship program to maintain their accreditation.

PSQH spoke with two experts to get their thoughts on the new regulations and what measures healthcare facilities should be putting in place.

Q: What are the top five things all hospitals need to know about the new CMS ruling?

Samantha Bastow: It is encouraging that more regulatory agencies like CMS and The Joint Commission, among others, are establishing standards to promote safer antibiotic prescribing practices for our patients and communities. In fact, shortly after the CMS ruling was announced, the Society for Healthcare Epidemiology of America (SHEA) praised the CMS decision, stating “the update by CMS moves U.S. hospitals closer to the goal of making patients safer by reducing inappropriate antibiotic use by 20% in inpatient settings by 2020.”

Given this, hospitals need to consider the following:

  1. Start working on these updated requirements now. Each organization has six months from the decision date to implement their ASP.
  2. Explicit instructions in meeting CMS requirements aren’t provided in this ruling, but hospitals are encouraged to seek guidance from established organizations like the CDC, Infectious Diseases Society of America (IDSA), and SHEA.
  3. Hospitals should also collaborate with other institutions who have well-established ASPs. Check out some examples online.
  4. An interdisciplinary team of quality, patient safety, infectious disease physicians, pharmacists, and information systems analysts should collaborate to develop, implement, and expand ASPs.
  5. Keep in mind resource constraints often pose one of the biggest challenges with implementing ASPs. Hospitals should identify where they can tap into existing resources and where new or repurposed resources are needed.

Q: What does the optimal ASP look like in terms of required staffing and the specific outcomes to measure? What are the things to consider when either creating or revamping your ASP?

Gina Thomas: One of the biggest challenges to consider is that there is a major education gap among patients that antibiotics can cure all manner of ills. Therefore, providers need to be equipped with patient education materials so they can explain what the potential consequences are of overuse.

Providers also must be equipped to help patients manage their discomfort with alternative methods.

Bastow: While CMS does not specifically outline what the ASP must consist of, organizations such as the CSC, IDSA, and SHEA provide guidance on the following areas:

  • Formulary management. Set formulary restrictions for select antibiotics and establish a clear approval process for restricted antimicrobials.
  • Consistently review organizationwide antimicrobial prescribing patterns (especially those which are restricted) and use this information to provide targeted education to providers.
  • Outcomes measures. Determine which outcomes will measure the impact of ASP efforts and the resources required to pull and analyze this data. Examples of outcomes may include the rate of hospital-acquired infections, the rate of antibiotic-associated adverse drug events, the rate of resistance for specific pathogens, annual expenditures for antibiotic medications, etc.

Other recognized best practices include standing up formal education processes, developing clinical guidelines and/or pathways, establishing de-escalation practices, and antibiotic cycling. Fortunately, there is a plethora of resources for hospitals to use to develop or improve an ASP.

Q: How do you manage the most common barriers to developing a top-notch ASP? What are the problems surrounding antibiotics in hospitals, and why can’t they seem to get it right?

Thomas: Antibiotic stewardship, isn’t a new concept and hospitals have been focused on this for years. The most successful ASPs would include alignment with outpatient providers and walk-in clinics. However, this has historically been a challenge because of the fragmentation between healthcare systems and outpatient providers. Another challenge is building greater awareness of antibiotic stewardship among the public. For years, the public has been conditioned to ask for antibiotics as a first-line treatment. This is where widespread education programming comes into play. However, patient education has typically been deprioritized due to lack of resources and budget. An important point to remember is that these costs will be offset by a decrease in both inappropriate utilization of antibiotics and denied reimbursement claims.

Bastow: Sometimes resource constraints limit how robust an ASP is at a given institution. Because it often requires additional staff, information systems support, and quality measures processes, this may be difficult for a hospital to prioritize if it is not viewed as an “essential” function for providing patient care. Using the business case and proposal examples provided by other hospitals is a great way to illustrate long-term payoff.

Q: How are factors such as increasing rates of antimicrobial resistance and government programs supporting the development of new agents that are making strong ASPs more important than ever?

Thomas: While pharmacists have been tackling appropriate utilization of antibiotics for some time, we see continued antibiotic over-prescription. This has given way to a rise in superbugs which make strong ASPs more necessary than ever. In fact, the CDC estimates at least 2 million people get an antibiotic-resistant infection and at least 23,000 people die in the U.S. each year. These superbugs wreak havoc on individuals’ health (especially those who are immunocompromised) as well as impact the out-of-pocket costs for individuals and increase the potential for decreased hospital reimbursement for inappropriate utilization.

Bastow: The CDC also reports that one in three patients who die in a hospital are diagnosed with sepsis, further emphasizing the importance of having effective antimicrobial medications for life-threatening diseases such as this. The reality is that resistant bacteria are being identified faster than new antibiotics are being developed to treat them. However, support is growing from regulatory agencies such as CMS and The Joint Commission as well as national organizations like IDSA, SHEA, and the CDC. There is now better guidance for developing rigorous ASPs as well as enforcement of these “best practices.” With more support from legislative action, we hope to see more development of new antimicrobial agents to target multidrug-resistant organisms.

Q: Some new antibiotics demonstrate superior outcomes despite very high cost. Can you elaborate on some of the latest analysis?

Bastow: In the past five years, there have been four new beta-lactamase inhibitor combination products approved: Zerbaxa® (ceftolozane and tazobactam) in 2014, Avycaz® (ceftazidime and avibactam) in 2015, Vabomere® (meropenem and vaborbactam) in 2017, and Recarbrio® (imipenem, cilastatin, and relebactam) in 2019.

There are also at least four more antibiotics in this class in Phase III trials. Hospitals will need to evaluate the evidence to gauge whether these new agents result in superior outcomes when compared to older antibiotics like Zosyn®. Once the evidence is better understood, hospital pharmacy leaders can decide if these products should be added to the formulary and how to best steward the use of these broad-spectrum antibiotics. If there is no clear benefit to patients beyond what is currently available, then hospitals should consider reserving new agents in the event resistant organisms are uncovered.

It’s important to note that some of these newer agents are more than 1,000 times the cost of oral therapy within this drug class and up to 15 times the cost of older IV options in the class. Hospitals need to consider whether it makes sense to restrict the use of the newer agents to patients who are infected with pathogens demonstrating resistance to all other options. Not only does this type of restriction help from a cost perspective, but limited exposure prevents resistance.

There is currently a high volume of persistent drug shortages among antimicrobials. According to an American Society of Health-System Pharmacists report, antimicrobials are in the top five categories of medications affected. Therefore, drug shortages remain an impediment to successful antimicrobial stewardship.

John Palmer is a freelance writer who has covered healthcare safety for numerous publications. Palmer can be reached at johnpalmer@palmereditorial.com.