In finalizing a regulation requiring antibiotic stewardship programs in hospitals, the Centers for Medicare and Medicaid Services (CMS) made several revisions based on comments from the field.

For example, an unidentified commenter urged CMS to modify the requirements for showing improvements in antibiotic stewardship.

“The commenter does not believe it is appropriate or accurate to solely use antibiotic resistance within the hospital to demonstrate antibiotic stewardship program success,” the CMS acknowledged.1 “The commenter states that numerous external factors contribute to resistance patterns, including prescribing patterns of local practitioners who may not be connected to the hospital, community-onset infections, and patient transfers from other facilities.”

The point was taken and the CMS revised the document.

“We appreciate the suggestion and have modified and also deleted elements of this language,” the CMS states. “We agree that it would not be appropriate to use antibiotic resistance within the hospital as the sole criterion to demonstrate antibiotic stewardship program success or to evaluate a hospital’s antibiotic stewardship efforts. Therefore, we have deleted this portion of the regulatory language at §§ 482.42(b)(2)(iii) and 485.640(b)(2)(iii).”

With the revisions, the CMS acknowledged that external factors can undermine antibiotic resistance efforts in a facility, creating a negative impact in the short term. “Hospitals will still need to ensure that their antibiotic stewardship programs are following nationally recognized guidelines and best practices while documenting the evidence-based use of antibiotics.”

The CMS revision of this section now reads that the program “documents any improvements, including sustained improvements, in proper antibiotic use.”

Another change based on comments was the provision in the proposed rule requiring that the leaders of the infection prevention and control and antibiotic stewardship programs be specifically appointed by the governing body of a hospital.

“We appreciate this concern,” the CMS stated. “The goal of this proposed requirement was to ensure that the infection prevention and antibiotic stewardship leaders are vested with authority from the leadership of the hospital. To maintain this concept while allowing more flexibility, we have changed these requirements.”

The CMS revised §§ 482.42(b)(1) and 485.640(b)(1) to now require that the hospital ensure that the appointed leaders of infection control and antibiotic stewardship efforts are “qualified through education, training, or experience in infectious diseases and/or antibiotic stewardship. … The selection process must include meaningful opportunity for input from members of the medical, nursing, and pharmacy staffs.”


  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.