A proposed rule submitted to the Federal Register by the Centers for Medicare and Medicaid Services (CMS) last week calls for combined antibiotic stewardship and infection prevention and control programs in all hospitals that receive federal funding, noting that coordinated activities can save $1 billion in annual costs.
"The Department of Health and Human Services [HHS] is particularly concerned about HAIs [healthcare-associated infections], as they are a significant cause of morbidity and mortality in the United States," the authors said. In 2011, 722,000 people acquired an HAI, and 75,000 people died due to HAI-related complications.
The proposed rule introduces new and adapted conditions of participation to the Social Security Act, which hospitals must follow to receive Medicare or Medicaid funding. Along with requirements to reduce infection and resistance rates in hospitals, the proposed rule also expressly prohibits discrimination on the basis of religion or sexual orientation, expands the roles of physician assistants, and addresses other barriers to hospital quality of care.
The rule proposes three key interventions in alignment with reducing nosocomial infections and advancing the federal strategy for Combating Antibiotic-Resistant Bacteria (CARB), which seeks to establish antibiotic stewardship programs in all acute care hospitals by 2020. Specifically, CMS seeks to require: (1) implementation of a hospital-wide ASP, (2) enhancements to infection prevention and control programs and greater coordination of surveillance activities with the ASP, and (3) involvement of hospital leadership at all levels.
The authors estimate that implementation of comprehensive antibiotic stewardship, along with improved infection prevention and control, may have a one-time cost of $1.2 billion with an annual cost savings of $1 billion and the possibility of reducing unnecessary patient suffering, hospitalization, and death, the authors said.
ASPs required in all hospitals
The proposed rule, published Jun 16, is the first to require active and hospital-wide antibiotic stewardship in facilities that receive Medicare or Medicaid funding, which accounted for $250.3 billion in payments to hospitals during 2014. During the same period, only 40% of US hospitals had some form of antibiotic prescription oversight, the CMS said, in reference to a 2014 report from the Centers for Disease Control and Prevention (CDC).
The CMS cites additional CDC data that demonstrates hospital-wide issues with inappropriate prescribing practices for urinary tract infections, overuse of critical drugs such as vancomycin, and antibiotic use not supported by diagnostic testing. Even a 30% reduction in the inappropriate use of broad-spectrum antibiotics could reduce Clostridium difficile infections (CDIs) by 26%, the authors said.
The requirement outlines the basis for an evidence-based ASP aligned with national guidelines, while allowing hospitals flexibility to adapt programs to their local needs and logistical situations. The rule also requires an ASP to be implemented and maintained in critical access hospitals, noting a study that found greater levels of antibiotic use in smaller hospitals.
At a minimum, ASPs should improve coordination among all hospital departments for determining appropriate antibiotic use and reducing the development of resistant strains, the authors said. Typical components of such a program would define accountability for prescribing practices not only among medical, nursing, and pharmacy staff, but also at all levels of infection control and Quality Assessment and Performance Improvement (QAPI) sectors.
Antibiotic prescribing should be based on the best available evidence, according to the rule, which includes diagnostic testing and patient chart monitoring. Program evaluation should focus on reducing adverse consequences of inappropriate antibiotic use, specifically CDI rates and the growth of antibiotic resistance, the authors said.
Though the rule would require a fairly comprehensive program, the CMS advises hospitals to build their practices on whichever national guidelines best fit their situation, offering as examples recommendations recently put forth by the CDC, the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), and the American Society for Health System Pharmacists (ASHP).
"CMS believes that the proposed requirement for a hospital to implement and maintain an active and hospital-wide antibiotic stewardship program will prove to be an effective means to improve hospital antibiotic-prescribing practices and thereby curb patient risk for potentially life-threatening, antibiotic-resistant infections, including CDI," the authors said.
After the rule is finalized, CMS will develop guidelines that will address how compliance with ASP goals can be measured for each hospital, the authors said.
Updating infection control and prevention
The ASP requirement is part of a broader focus on reducing disease transmission within and between hospitals, the authors said. To this end, the rule proposes key changes to hospital infection prevention and control programs, pushing them to work closely with the ASP to reduce HAIs and align their efforts with the 2013 HHS Action Plan to Prevent Healthcare Associated Infections.
The new rule represents that first time that infection prevention and control requirements for receipt of CMS funding have been updated since 1986. Though hospitals are already required to track CDI cases, CMS expands the focus on prevention of infection and resistance, noting that "our intent is to promote larger, cultural changes in hospitals such that prevention initiatives are recognized on balance with their current, traditional control efforts."
New and updated requirements to infection prevention and control programs include:
- Requiring the program to reflect the scope and complexity of hospital services, especially in surgical departments
- Facilitating communication across departments and between infection control and prevention and ASP staff
- Establishing a mechanism to rapidly detect targeted multi-drug resistant organisms and prevent their transmission
- Expanding surveillance to capture infection risk as patients move through the hospital and across the healthcare continuum.
A focus on the impact of outpatient facilities on inpatient units is an integral component to reducing HAIs, the authors said, adding that "the reality is that patients move between settings with great frequency and carry organisms with them, hence it is imperative that hospitals approach multi-drug resistant organism control from the broader perspective in order to protect their patients and staff."
Leadership and program coordination
The proposed rule establishes leadership structures that foster partnerships between infection control and prevention staff and ASP directors, thus linking stewardship activities. The appointment of program leadership should also be done in such a way as to garner support for both initiatives from hospital governing bodies and staff at all levels, the authors said, noting 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."
The ASP leader should have extensive experience with prescribing practices, HAI reduction, and antibiotic resistance monitoring. The leader will document all improvements to antibiotic use and facilitate competency-based training for relevant staff, the authors said.
The infection control and prevention leader will likely have primary training in nursing, medical technology, microbiology, or epidemiology with specialized experience in infection control. She or he should be selected by high-level clinical leadership on the basis of input from across the hospital, the authors said. The program leader should be responsible for documenting program activities and outcomes, communicating with the QAPI on all infection-related issues, prevention and control of HAIs, and initiating collaboration with the ASP director.
The new definitions for hospital responsibility and accountability, along with a requirement that hospital governing bodies establish systems for infection surveillance and antibiotic use, will allow hospitals to institute programs that are hospital-wide, active, and sustainable, the rule states. The proposed leadership structure ensures that issues related to HAI prevalence or antibiotic use are addressed at multiple levels in collaboration with quality assurance leadership.
"We wish to promote a hospital-wide culture of safety and quality, and we are proposing these regulatory changes to introduce a catalyst at the leadership level," the CMS said.
Economic investment and savings
The rule has entered a 60-day comment period before it is finalized, and the CMS acknowledges that the new requirements represent a significant financial investment for hospitals, one that may be initially burdensome, yet hold potential for future cost savings and vast improvements to patient care and well-being.
Estimated costs for implementing or adapting an infection prevention/control and ASP program for 2,940 acute care hospitals include a total one-time cost of $693 million to $1.2 billion, the CMS said. Costs for 1,328 critical access hospitals would reach $45 million annually, with a one-time cost of $5 million and annual cost-savings of $37 million. Annual drug cost savings are estimated to reach $520 million for acute care facilities, and $37 million for critical access hospitals.
The total annual cost for an ASP alone at an acute care hospital that does not currently have a comprehensive stewardship program would be $100,900, the authors said, much of which would be dedicated to salaries of a physician, pharmacist, and network data analyst. Annual ASP costs at critical access hospitals would likely reach $44,800.
Some of the most easily measured savings would likely be related to reduced CDI rates, the authors said, noting a CDC ASP model that showed how a combined infection prevention/control program and ASP lowered CDIs among Medicare beneficiaries by 101,000 infections per year. Other studies have found that combined programs that lower CDI hospitalization and readmission can save $2.5 billion in federal funding over 5 years, the authors said.
"We believe that these changes, together, would promote a more patient-centered culture of safety focused on infection prevention and control as well as appropriate antibiotic use, while allowing hospitals the flexibility to align their programs with the guidelines best suited to them."
Jun 16 Federal Register proposed rule
Jun 13 CMS fact sheet