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from Pharmacy Practice News – January 9, 2020
by Thomas Rosenthal

An estimated 15% of the nation’s hospitals have not met the impending Centers for Medicare & Medicaid Services (CMS) conditions of participation to implement an effective antibiotic stewardship program (ASP) by March 30, 2020, according to the CDC.

While pharmacists and other stakeholders mobilize to close that compliance gap, antibiotic resistance—and its effects—continues to grow. According to the CDC, in 2016, at least 2 million Americans were infected with resistant bacteria. By 2019, the number of cases had increased to nearly 3 million. Deaths from such infections almost doubled, from 23,000 in 2016 to 45,000 in 2019. In addition, in 2017, there were 223,900 cases of Clostridioides difficile and at least 12,800 people died.

Still, there is some cause for optimism: at least 85% of hospitals in the United States have met all seven of the CDC’s recommended core elements for ASP programs, according to the CDC’s 2018 National Healthcare Safety Network survey ( This level of compliance is more than double the 41% of hospitals with operational ASPs in 2014, which was when the CDC called on hospitals to implement programs to reduce the 30% of unnecessary or sub-optimal antibiotics prescribed in U.S. acute care hospitals.

At the end of September 2019, CMS issued the regulation that all hospitals in the United States participating in Medicare or Medicaid programs will have six months to develop and implement an ASP as part of their infection control efforts.

The CMS rule, proposed in 2016, is patterned after guidelines issued by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA), which began sounding the alarm over antibiotic resistance more than 20 years ago, as well as guidelines issued by the Joint Commission and the CDC. Although these organizations issued recommendations, the CMS rule carries more weight.

But perhaps not enough weight: in an informal poll of participants in a recent webinar hosted by Lumere ( of Chicago, 3% of hospitals had no program whatsoever, and 15% had minimal ASP activities and believed they had a significant amount of work to do to comply with CMS, according to Samantha Bastow, PharmD, a pharmacy solutions advisor at Lumere, who moderated the webinar.

What CMS Wants

The CMS rule lays out the requirements for a hospital’s ASP in general terms. In addition to designating an ASP leader, Section 485.640 of the rule requires hospitals to:

  • demonstrate coordination among all staff responsible for antibiotic use and resistance, including medical staff, nursing and pharmacy services;
  • document the evidence-based use of antibiotics in all departments and services; and
  • demonstrate improvements in “proper antibiotic use, such as through reductions in C. difficile infection and antibiotic resistance in all departments and services of the hospital.

Lisa Blanchette, PharmD, the system director for infusion and specialty pharmacy services at Novant Health in Winston-Salem, N.C., and one of the webinar participants, broke down the main components that CMS is looking for in a hospital’s ASP:

  1. The institution will need to identify and appoint a qualified ASP leader who should have either experience or training in ASP strategies, she said.
  2. CMS also is “looking for coordination and integration of your antimicrobial stewardship program with infection prevention, quality improvement programs, medical staff, nursing and pharmacy,” Dr. Blanchette said, noting that the requirement is similar to the current Joint Commission guideline.
  3. The institution will need to demonstrate its ability to document and track ASP performance, including the ability to show demonstrated outcomes of interventions that the ASP is implementing, as well as a strategy for educating and communicating to care providers on ASP activities at the institution.

To further guide them, hospitals are encouraged to seek best-practice recommendations from IDSA ( and SHEA (, as well as to comply with the CDC’s 2019 updated seven core elements of a hospital’s ASP ( and an ASP core element assessment tool (

CMS has been clear on its intent to hold health systems to a high standard on ASP surveillance. Dr. Blanchette noted, for example, that the agency is requiring that “each institution has systems in place for tracking antibiotic use and the ability to demonstrate that ASP interventions have been implemented, have been successful and can be sustained.”

Dr. Bastow said the CDC’s reporting requirement to track antibiotic prescribing and resistance patterns was a particular point of concern in the Lumere poll; 38% of respondents said such data mining required the most work in their hospital’s ASP.

Fortunately, several strategies can help facilities build a robust tracking and reporting system, according to Dominic Chan, PharmD, a clinical coordinator of antimicrobial stewardship at Legacy Health, in Portland, Ore. One key step is to create an ASP committee comprising representatives from all medical and administrative areas, Dr. Chan noted. Meeting with the hospital’s financial and regulatory compliance officers as well as the team managing the electronic health records is also important, he said.

As for the ASP committee, Dr. Chan suggested that a patient advocate serve in a nonofficial role. “We’re talking about regulatory outcomes and regulatory requirements, but we want to make sure that we’re providing value back to patients.” At his system, participation of “a patient champion really helped to pull the program out of its myopic approach,” he stressed.

Dr. Chan also stressed the importance of ASP directors meeting with competing hospitals in the region to share knowledge about developing their programs. Noting that peer-to-peer exchange was helpful when his system developed their program, he said the discussions “helped us to quickly understand the depth of complexity needed with respect to the geographic antibiotic-resistant patterns.”

Dr. Bastow said respondents to the Lumere poll identified several other ASP areas requiring work: 29% cited educating clinicians on better prescribing patterns; 26% pointed to the need to develop clinical pathways and order sets; and 7% cited the need to gain leadership support for resources and accountability.

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