In a long-anticipated action, the Centers for Medicare and Medicaid Services (CMS) recently finalized its 2016 rule requiring antibiotic stewardship programs in hospitals.

A CMS final regulation issued Sept. 30, 2019, requires that a hospital’s “infection prevention and control and antibiotic stewardship programs be active and hospital-wide for the surveillance, prevention, and control of healthcare-associated infections and other infectious diseases, and for the optimization of antibiotic use through stewardship.”1

The news was welcomed by infection preventionists (IPs), who will work with clinicians and administrators on antibiotic stewardship teams designed to reign in the misuse and overuse of antibiotics.

“We are very excited about the final rule and the fact that antibiotic stewardship programs are now required,” says Connie Steed, RN, president-elect of the Association of Professionals in Infection Control and Epidemiology (APIC). “They also sort of integrated this - but still kept it separate - [with] the infection prevention and control program.”

In that sense, the CMS rule gives IPs a seat at the stewardship table, but does not saddle them with an unfunded mandate to run the programs.

“We agree that careful coordination between the infection prevention and control and antibiotic stewardship programs is essential and this is stated explicitly in the regulatory text,” the CMS states in the final rule. “However, we believe it is also important to highlight the distinctions between the two programs. Infection prevention and control programs are almost exclusively staffed by infection preventionists, the overwhelming majority of whom do not prescribe or manage antibiotics. Antibiotic stewardship programs must be staffed by people who are very familiar with antibiotics.”

The Centers for Disease Control and Prevention (CDC) recommends that a pharmacist or physician leads the antibiotic stewardship team. While acknowledging this will most likely be the case in actual practice, the CMS regulation leaves flexibility at the local level to make such leadership decisions.

IPs in hospitals that have not established a stewardship program should certainly expect to play a role in implementing the new requirements, Steed says. First and foremost, the regulation requiring an antibiotic stewardship program falls under the CMS Infection Control Conditions of Participation.

“Infection prevention needs to be involved in the program and be a team player,” she said. “It does not need to be run by an infection preventionist. Expertise is needed from the pharmacy area and infectious disease docs to help lead the program. IPs are clearly involved with day-to-day education, surveillance, and other things with regard to antimicrobial stewardship.”

An area of importance to APIC was that in multihospital systems, each facility would have the expectation and resources to form a stewardship team, much as they have their own infection control programs, Steed says.

“To me, the way it is written affords that capability,” she says. “From an infection control standpoint, it indicates that each facility within a multihospital system has to have their own program employees, where their needs are being addressed and that they have a qualified individual or individuals designated at the hospital as responsible for communicating that program [within] the multihospital system.”

The CMS also left flexibility on which professional guidance facilities follow in implementing stewardship programs, though the CDC’s “seven core elements”2 recommendations have already been widely adopted.

“The CDC has core measures for these programs, and at the present time that really is the national standard,” Steed says.

Heralding the CMS action, the Society for Healthcare Epidemiology of America (SHEA) said hospitals may now be able to achieve a national goal to reduce unnecessary antibiotic use by 20% in 2020.

There has been broad consensus for years that reining in the overuse and misuse of antibiotics will lessen the “selective pressure” that has driven a surge of multidrug-resistant bacteria. Moreover, some bacteria can transfer resistant plasmids to other microorganisms, leading to “superbugs” that are resistant to virtually all available antibiotics. Overuse of broad-spectrum antibiotics also blasts the commensal bacteria in the gut, clearing the way for Clostridioides difficile to proliferate and cause life-threatening enteric infections. The CDC estimates that C. diff infections strike half a million patients annually and cause about 15,000 deaths.

In a conservative estimate, a CDC study2 published this year estimated that a CMS antibiotic stewardship mandate in hospitals would save $25 billion a year after factoring in the societal costs of morbidity, mortality, and lost years of life.

One of the co-authors of that study, Clifford McDonald, MD, associate director for science in the CDC Division of Healthcare Quality Promotion, was enthusiastic about the CMS action.

“We’re happy to see this, because we are trying to improve stewardship and we’re glad to have a partnership with CMS,” he says.

The regulation will push wider adoption of the CDC stewardship recommendations, which had been adopted by 76% of U.S. hospitals as of 2017, he says. That was the most recent data3 available as this report was filed, but it shows considerable progress. For example, in 2014 only 41% of hospitals had adopted all seven CDC core elements for antibiotic stewardship.

As measures to control the use and duration of antibiotics take hold, there are signs that “high-risk” antibiotics like fluoroquinolones are being cut back in clinical settings. A recently published paper4 McDonald coauthored showed a decline in fluoroquinolone use, which is notorious for setting up C. diff infections by disrupting the gut flora of patients.

“In this more recent [data] fluoroquinolones are no longer the number one class of antibiotics,” he says. “Cephalosporins are now, but from this and other papers, we are seeing that fluoroquinolones have decreased.”

Reduction in the use of fluoroquinolones has been credited with dramatic reductions in C. diff in the United Kingdom.

The CMS said its final rule will go into effect six months after the Sept. 30, 2019, publication date.


  1. CMS. Medicare and Medicaid programs: Hospital and critical access hospital (CAH) changes to promote innovation, flexibility, and improvement in patient care. Federal Register Sept. 30, 2019. Available at: Accessed Oct. 17, 2019.
  2. Scott RD, Slayton RB, Lessa FC, et al. Assessing the social cost and benefits of a national requirement establishing antibiotic stewardship programs to prevent Clostridioides difficile infection in US hospitals. Antimicrob Resist Infect Control 2019;8:17.
  3. CDC. Antibiotic resistance & patient safety portal. Available at: Accessed Oct. 17, 2019.
  4. Tabak YP, Srinivasan A, Kalvin C, et al. Hospital-level high-risk antibiotic use in relation to hospital-associated Clostridioides difficile infections: Retrospective analysis of 2016–2017 data from US hospitals. Infection Control Hosp Epidemiol 2019;1-7. doi:10.1017/ice.2019.236.