By Gary Evans, Medical Writer
A new analysis of the immense societal costs of Clostridioides difficile infection (CDI) may spur the Centers for Medicare & Medicaid Services (CMS) to finalize a regulation requiring antibiotic stewardship in hospitals, Hospital Infection Control & Prevention has learned.
The CMS proposed regulation requiring antibiotic stewardship was issued in 2016 but has not been finalized. As proposed, the regulation “would require a hospital to develop and maintain an antibiotic stewardship program as an effective means to improve hospital antibiotic-prescribing, [and] curb … potentially life-threatening, antibiotic-resistant infections.”1 This would promote better alignment of hospital infection control and antibiotic stewardship efforts with nationally recognized guidelines and “heighten the role and accountability of a hospital’s governing body in program implementation and oversight,” CMS states.
In addition, last year, the nation’s leading infection control groups emphasized that infection preventionists and healthcare epidemiologists are critical members of antibiotic stewardship teams.2 The paper was co-authored by the Association for Professionals in Infection Control and Epidemiology (APIC), which is advocating finalization of the CMS antibiotic stewardship rule. An advocacy message on the APIC website urging members to lobby for finalization of the stewardship regulation puts the action in the context of history:
“Although infection control was elevated to a Medicare Condition of Participation (CoP) in 1986, it has essentially been unchanged for more than 30 years,” APIC states.3 “Because of this lack of action, current requirements no longer fully conform to current standards for infection prevention and control, creating a burden on hospitals that are currently operating under regulations that are outdated, inefficient, and inconsistent with infection prevention and control requirements in other healthcare settings. Urge CMS to finalize the proposed revisions to Medicare hospital CoPs.”
As proposed in the 2016 CMS rule, IPs would “be responsible for communication and collaboration with the antibiotic stewardship program,” CMS states. “We believe that collaboration between the hospital’s infection prevention and control and antibiotic stewardship programs will provide the optimal approach to reducing HAIs and antibiotic resistance.”
If finalized as proposed, the CMS regulation would require documentation of the evidence-based use of the hospital formulary. CMS said the expectation would be “sustained improvements” in antibiotic use and subsequent “reductions in C. diff and antibiotic resistance in all departments and services of the hospital.”
Making the Societal Case
There has been broad consensus for years that reining in the overuse and misuse of antibiotics will lessen the pressure that selects out multidrug-resistant bacteria. As bacteria mix and exchange resistant plasmids, some become resistant to virtually all available antibiotics.
Overuse of antibiotics also disrupts the commensal bacteria in the gut, clearing the way for C. diff to proliferate and cause diarrhea and a cascade of more serious problems in the colon. The Centers for Disease Control and Prevention (CDC) estimated in 2015 that CDI strikes nearly half a million patients a year, leading to 29,000 deaths — 15,000 of which are directly attributable to the enteric pathogen.4
The CMS proposed rule to mandate antibiotic stewardship programs did not fully incorporate this immense societal toll, but new CDC research now provides that missing piece. In a conservative estimate, the study5 concludes that an antibiotic stewardship mandate in hospitals would save $25 billion a year when the societal costs of factors like morbidity, mortality, and lost years of life are added to the economic equation, says lead author R. Douglas Scott II, PhD, a CDC health economist.
“In their proposed regulation, they recognized they did not have any information related to mortality and risk reduction,” he says. “They actually called for information in that proposal. This paper is a response to that. It really changes the whole dynamic of their regulatory impact assessment.”
In looking at the societal impact of antibiotic stewardship programs, Scott and CDC co-authors focused only on CDI. The analysis looked at the costs of treatment, interventions, attributable deaths, and the “value of statistical life.”
“From a societal perspective, we are asking, ‘What will we usually pay to save a year of life?’” says co-author Clifford McDonald, MD, associate director for science in the CDC Division of Healthcare Quality Promotion. “When you consider what we pay to save a year of life, [antibiotic stewardship] is very cost-effective. You get a lot of effect for the costs you pay. That’s why these numbers are bigger.”
Including these values in a model projected over 2015 to 2020, the net social benefits of mandating antibiotic stewardship in hospitals range from $21 billion to $624 billion. Even without the societal values associated with reducing morbidity and mortality, the net benefits of a stewardship program save some $300 million to $7.6 billion.
“It gets kind of small, but in both scenarios there is still a benefit to a stewardship program,” Scott says. “People can argue about how good these numbers are. I looked at the available evidence, and I used a fairly conservative estimate based on the range of estimates that were available.”
Again, the range of benefits is probably conservative because the formula lacked a monetary value of severe morbidity in CDI cases.
“We didn’t have any information on severe cases, so we have undercounted that,” Scott says. “There are some other issues, but we are probably low-balling the benefit estimate.”
After adding in the societal benefits and the economics of morbidity and mortality, “It’s a no-brainer,” he says. “That’s not necessarily coming from me, but I will let the numbers speak for themselves.”
In the never-ending fight for federal funding, in 2016 the Department of Health and Human Services (HHS) told its agencies to use an economic model that includes the societal costs.6 Other government agencies, such as the Environmental Protection Agency and the Department of Transportation, have been using this model for years, showing the huge potential impact of proposed regulations, Scott says.
“HHS has to compete for Congressional attention in order to get more resources,” he says. “You’re up against EPA and DOT numbers, and [legislators] are wondering where can they get the biggest bang for the buck. We have kind of been on the short end of things, which is why HHS developed the guidelines.”
In addition to this study, the CDC has been emphasizing the amount of federal dollars invested fighting antibiotic resistance, recently posting a detailed map that shows the funds spent in each state in 2018. A total of $240 million in state activities were supported by the CDC, ranging from $288,861 in Vermont to $7.2 million in Tennessee.7
Traditional economic studies of HAIs have focused on the toll on hospitals and payers, but studies projecting out to include societal costs is the logical next step, McDonald says.
“For example, we don’t prevent motor vehicle accidents just to save money — it is to save lives,” McDonald says. “In the larger scheme of things, we pay as a society for ‘length’ of life. That’s what we do in healthcare, and we pay for it.”
This is far removed from the days when hospitals were reimbursed to some extent for medical complications, creating disincentives to prevent infections, he adds. That era is over with CMS initiatives like value-based purchasing and pay for performance. Even if you cede the high ground — looking at antibiotic stewardship strictly from a payer perspective — it still makes sense, McDonald says.
“The business case has been made for the payers,” he says. “If you prevent the C. diff, you prevent the readmission and shorten the length of stay.”
It’s worth reiterating that this potential societal windfall is solely focused on antibiotic stewardship programs in hospitals to prevent C. diff HAIs.
“We didn’t look at community-associated, which we think is now probably 40% of the pie,” McDonald says. “We were just looking at the 60% that are healthcare-associated. It really translates to acute care hospital-associated C. diff.”
In any case, most C. diff infection in the community is traced back to healthcare contacts or prior hospitalization.
“We realize a lot of them have their onset outside the hospital, but when you use an antibiotic you mess up the microbiome for two or three months,” he says.
“Inpatient antibiotic use is casting a shadow over people for several months after they leave the hospital.”
The benefits estimated also are conservative in that they focus on CDI and not the many other adverse outcomes associated with antibiotic misuse, he says.
“Antibiotic stewardship also prevents other adverse events,” McDonald says.
“There are a lot of allergic reactions, and it is a very common cause of ER visits among children, for example. It’s a great cost benefit for society.”
The CMS proposal has not become law, but The Joint Commission began enforcing antibiotic stewardship in 2017. The Joint Commission Medication Management (MM) standard MM.09.01.01 requires antimicrobial stewardship programs.8
DNV GL Healthcare’s NIAHO (National Integrated Accreditation for Healthcare Organizations) standards also mandate antibiotic stewardship for CMS hospital accreditation.9
- CMS. Medicare and Medicaid Programs: Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care. ID:CMS-2016-0095-0001. June 16, 2016. Available at: https://bit.ly/2HUpKNp.
- Manning L, Septimus EJ., Dodds LS. APIC/SHEA/SIDP Antimicrobial Stewardship Position Paper. Antimicrobial stewardship and infection prevention – leveraging the synergy: A position paper update. Am J Infect Control 2018; 46(4). DOI: https://doi.org/10.1016/j.ajic.2018.01.001.
- APIC. Urge CMS to Take Action on Antibiotic Stewardship. Available at: https://bit.ly/2GcCSfn.
- CDC: Nearly half a million Americans suffer from C. difficile infections in single year. 2015. Available at: https://bit.ly/2Oke8Fs.
- 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;22(8). Available at: https://bit.ly/2UCEB0o.
- HHS. Guidelines for Regulatory Impact Analysis. 2016. Available at: https://bit.ly/2D85jHi.
- CDC. Antibiotic Resistance Investments. Available at: https://bit.ly/2oFoxeZ.
- The Joint Commission. Approved: New Antimicrobial Stewardship Standard. Joint Commission Perspectives 2016;36(7). Available at:
- DNV GL. Change History of DNV GL - Healthcare NIAHO® Accreditation Requirements for Hospitals to CMS 42 C.F.R. 42 § 482 Conditions of Participation for Hospitals: Rev. 18-2. Jan. 21, 2019. MM.8:SR.1-SR.6. Available at: https://bit.ly/2tjWSnF.