CMS Final Rule on Antibiotic Stewardship Programs

Oct. 18, 2019

On September 30, 2019, the Centers for Medicare and Medicaid Services (CMS) released a final rule that addresses antibiotic stewardship programs. This rule “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,” was first proposed in 2016. The rule requires all acute-care hospitals that participate in Medicare or Medicaid to develop and implement an antibiotic stewardship program as part of their infection control efforts. Two sections, § 482.42(b) and § 485.640(b), regarding hospital and critical access hospital (CAH) antibiotic stewardship programs, must be implemented by March 30, 2020.

§ 482.42 requires the hospital to:
  1. Provide a sanitary environment to avoid sources and transmission of infections and communicable diseases
  2. Develop an active program for the prevention, control, and investigation of infections and communicable diseases, and
  3. Assign a designated infection control officer
§ 485.640 requires the following goals for an antibiotic stewardship program be met:
  1. Coordination among all components of the CAH responsible for antibiotic use and resistance, including, but not limited to, the infection prevention and control program, the QAPI program, the medical staff, and nursing and pharmacy services;
  2. Document the evidence-based use of antibiotics in all departments and services of the CAH; and
  3. Demonstration of improvements, including sustained improvements, in proper antibiotic use, such as through reductions in, CDI and antibiotic resistance in all departments and services of the hospital.