Implications of CMS’ New Antibiotic Stewardship Rule

CMS released revised conditions of participation for hospitals and critical access hospitals, which require the development and implementation of antimicrobial stewardship programs (ASPs) to help reduce inappropriate antibiotic use and antimicrobial resistance.

This is an expansion of a previous ruling in 2016, which required all nursing homes to establish an ASP at their facilities. That same year, there was a rule proposal titled,  “Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care,” during which time discussions of requiring ASPs in hospitals began. With the rule now being published, each hospital who accepts Medicare and Medicaid has six months (from September 30th) to implement its ASP.

Although CMS does not necessarily outline detailed components and requirements of an ASP, hospitals are encouraged to seek best practice recommendations from national infectious diseases organizations like the Centers for Disease Control and Prevention (CDC), Infectious Diseases Society of America (IDSA), and the Society for Healthcare Epidemiology (SHEA).

Healthcare executives need to be aware that additional resources (new or repurposed) are often needed in order to develop and implement a formal ASP, says Samantha Bastow, PharmD, pharmacy solution advisor at Lumere, a Chicago-based company that provides healthcare leaders with evidence-based data to help them reduce costs and unwarranted variation in devices and drugs.

“As a first step, executives need to assess where the ASP fits within current hospital priorities and honestly assess where the organization is in terms of meeting the ruling requirements,” she says. “Start by asking, ‘Will this be an incremental change or are we starting from scratch?’”

According to John Hurst, PharmD, BCPS-AQ ID, senior director of Antimicrobial Stewardship for bioMerieux, ASPs are very active, multidisciplinary programs with several elements to fulfill, including active monitoring of the appropriate use of antimicrobials. ASPs require leadership, financial and educational commitments, as well as measurement of the utilization of antimicrobials, facility antimicrobial resistance, and feedback to providers who are prescribing antimicrobials, Hurst says.

In an update published by the CDC last year, nearly 25% of acute care hospitals were reported as not having an ASP. For these hospitals, it will be a much heavier lift and likely require substantial resourcing, Bastow says. The CDC published a helpful resource guide on how to establish core elements of an ASP in resource-limited settings.

“With this in mind, it is also important for executives to understand that ASPs are a team responsibility and it is key to encourage their staff from all disciplines (physicians, nurses, pharmacists, microbiology, infection control, etc.) to collaborate,” Bastow adds.

Related: Too Many Antibiotics Prescribed For Inappropriate Diagnoses

“The most critical factor is to establish a common organizational understanding that antibiotic stewardship isn’t solely the pharmacy department’s initiative­. It’s about creating the best outcomes for patients, which is every caregiver’s responsibility,” says Gina Thomas, BSN, RN, chief nursing officer at Lumere. “An effective program will require an all-hands-on-deck mentality from nurses, physicians, pharmacists, social workers, and patients alike. This starts with support from the executive team and requires a broad staff and community education program. These programs need to illustrate the consequences of overuse of antibiotics and help patients better understand how to manage discomfort without the need for antibiotics when antibiotics aren’t warranted.”

Statistics provided by the CDC report that one in three patients who die in a hospital are diagnosed with sepsis, Bastow says. This staggering statistic highlights the importance of having effective antimicrobial medications for life-threatening diseases such as this. Unfortunately, resistant bacteria are being identified faster than new antibiotics are being developed to treat them. Bastow says there are two main strategies to combat this issue:

1. ASPs to reduce the emergence of resistant organisms.

“The most important strategy is preventing the development of resistance, which in part comes from our ability as clinicians to steward the use of our antimicrobial agents,” she says. “We need to be thoughtful about who receives antibiotics and which agent is most appropriate for their specific infection type, patient-specific factors, and community antibiograms.”

2. Development of new antimicrobial agents.

“The next most important strategy is gaining access to effective antibiotics when our prevention strategies were not enough,” she adds. “One example is the “10 x ‘20 initiative” by the CDC, which is seeking to create 10 new systemic antibiotics by 2020. However, since this strategy is beyond the control of hospitals, it is vital that we all establish ASPs as a first line of defense in protecting patients and communities.”

Hurst says ASPs are required to have a pharmacist and physician to co-lead their programs to find diagnositics.

"Diagnostics are an important part of ASPs as they can help fulfill many elements of the CMS mandate and antimicrobial resistance reporting," Hurst says. "Diagnostics provide value to clinicians at multiple decision points in the prescribing process, including when to escalate, de-escalate, continue antimicrobial therapy, or not to initiate it in the first place."

He adds bioMerieux offers laboratory optimization consultants to help ensure workflow processes and diagnostic technologies are being used to their full capacities to help ensure data reaches clinicians faster to ensure appropriate antimicrobial use and improve patient outcomes.

Pharmacists have been tackling appropriate use of antibiotics for some time, according to Thomas.

“However, antibiotics continue to be overprescribed and we see the resulting rise in superbugs. Superbugs have a negative impact on costs, often resulting in greater out-of-pocket costs for individuals and a reduction in hospital reimbursements. Additionally, individuals with complicated illnesses don’t have the immune system to fight off most infections, let alone superbugs, which can be life threatening.” 

“Initially, additional costs may be incurred to establish effective processes to educate, manage, and monitor effective use of antibiotics. However, these costs will be offset by a decrease in inappropriate utilization of antibiotics and denied reimbursement claims,” Thomas says. “By reducing the number of superbugs, additional treatment will be negated, and poor outcomes associated with additional complications will be better managed. Antibiotics that were once effective for first-line treatment (and cost effective) can once again be used to treat common infections such as respiratory infections. With a vigilant antibiotic stewardship program, hospitals will see a decrease in hospital-acquired infections––a key indicator of infection control success.”