New CMS Rule on Hospital Antimicrobial Stewardship Programs Will Impact Hospitals Nationwide

By Sandy Perreand, Executive Director of Public and Government Affairs at bioMérieux

Last month, on September 26, 2019, the Centers for Medicare and Medicaid Services (CMS) passed a new rule titled, “Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care”.  The rule is effectively three rules combined into one, impacting a variety of areas for U.S. healthcare providers that receive reimbursement from Medicare or Medicaid.

The new provisions relating to infection prevention, infection control, and antimicrobial stewardship are especially notable given the impact that antimicrobial resistance could have on public health in the long term.  The rule amends the existing section that specifies the Conditions of Participation (CoP) that apply to hospitals accepting Medicare and/or Medicaid reimbursements to require that, “a hospital’s infection prevention and control and antibiotic stewardship programs be active and hospital-wide for the surveillance, prevention, and control of [hospital acquired infections] and other infectious diseases, and for the optimization of antibiotic use through stewardship,” and that a program, “demonstrate adherence to nationally recognized infection prevention and control guidelines for reducing the transmission of infections, as well as best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic-resistant organisms.”

While these Conditions of Participation do not require hospitals to adhere to a specific set of guidelines for implementing Antimicrobial Stewardship Programs (ASPs), they do require that hospitals demonstrate adherence to “nationally recognized” sources, referencing sources such as CDC’s Core Elements, Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), and American Society for Health Systems Pharmacists. The rule also requires that, “An individual (or individuals), who is qualified through education, training, or experience in infectious diseases and/or antibiotic stewardship, is appointed as the leader(s) of the antibiotic stewardship program.  The selection must include meaningful opportunity for input from members of the medical, nursing, and pharmacy staffs.”  CMS defers to individual hospital leadership to determine the appropriate level of qualifications and credentials for ASP leadership.

Guidelines for Antimicrobial Stewardship Programs have existed for several years.  CDC recommended in 2014 that all US hospitals have an ASP and published their guidelines, and hospitals have made a lot of progress since publication.  In a 2017 National Healthcare Safety Network survey, 3,816 of 4,992 acute care hospitals (76.4%) said they had met all seven of the CDC’s core stewardship elements—nearly doubling the number reported in 2014. The report goes on to say that, “But many hospitals in the United States still don’t have stewardship programs. While ASPs are currently required by the Joint Commission, an independent organization that certifies and accredits US hospitals, roughly 25% of US hospitals aren’t covered by that requirement. A significant number of these hospitals are CAHs, which are small, mostly rural hospitals that provide the only hospital service for a vast geographic region.”

Ideally, this new CMS rule will strengthen stewardship programs across the United States, because virtually all hospitals bill to Medicare and Medicaid, so these conditions will have a broad impact and greatly affect hospitals with inadequate or minimal programs. The largest challenge will be for hospitals without stewardship programs. Community Access Hospitals and resource constrained hospitals who don’t have programs may need assistance implementing them. Normally, CoPs go into effect within 60 days; however, because implementation may be challenging for some hospitals, the new CoPs will become effective 6 months after the effective date of the Final Rule to give providers additional time to come into compliance.


Opinions expressed in this article are not necessarily those of bioMérieux, Inc.

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