The Centers for Medicare and Medicaid Services (CMS) yesterday finalized new regulations that require US hospitals to develop and implement antibiotic stewardship programs (ASPs).
Under the new CMS conditions of participation (CoP) rule, which was initially proposed in June 2016, all US hospitals and critical access hospitals (CAHs) will be required to have infection prevention and control and stewardship programs in order to receive payments from CMS. CoPs are standards that US healthcare facilities seeking Medicare and Medicaid reimbursement must meet.
CMS says hospitals should follow guidance on implementing infection prevention and control programs and ASPs from nationally recognized sources, including the Centers for Disease Control and Prevention, the Infectious Diseases Society of America, and the Society for Healthcare Epidemiology. The programs must be implemented 6 months from the date the finalized policy is published in the Federal Register (Sep 30).
The rule was finalized along with other proposed changes aimed at promoting innovation, flexibility, and improvement in patient care.
"By requiring that hospitals have antibiotic stewardship programs that are not only active and hospital-wide, but also demonstrate adherence to nationally recognized guidelines for the optimization of antibiotic use through stewardship, the changes are aimed at effectively reducing the development and transmission of HAIs [healthcare-associated infections] and antibiotic-resistant organisms that ultimately will greatly improve the care and safety of patients while adding cost benefits for hospitals," CMS said in a fact sheet.
Federal commitment to stewardship
Antibiotic stewardship advocates say the new regulations are welcome.
"This will accelerate the implementation of stewardship programs in the United States," said David Hyun, MD, a senior officer with the antibiotic resistance project at the Pew Charitable Trusts. "This is a significant signal that the federal government is taking leadership and committing to antibiotic stewardship."
Hyun added that this policy, which covers all hospitals and CAHs that participate in Medicare and Medicaid, can serve as a foundation for other policies that build on and promote stewardship activities. "Having this as a foundational policy at the federal level is really important," he said.
The number of ASPs in US hospitals has steadily increased in recent years with the emergence of antibiotic resistance as a major public health threat. The CDC recommended in 2014 that all US hospitals have an ASP to address the rise in antibiotic-resistant pathogens and guide appropriate use of antibiotics, and it published a set of guidelines—the Core Elements of Hospital Antibiotic Stewardship Programs—to support implementation of these programs. 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.
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.
Hyun said that extending the ASP requirement to CAHs is "extremely important." But he also noted that these hospitals, which frequently have limited resources, will need help.
"There's definitely still work that needs to be done, in terms of making sure, now that the requirements are in place, that the smaller and more resource-limited hospitals are given the type of expertise and support that they need," Hyun said.
CMS says in the finalized rule that it's committed to partnering with federal agencies and other groups to provide extra technical assistance to these hospitals.
In 2016 CMS finalized a policy requiring US nursing homes to have ASPs. The delay over finalization of the rule for hospitals and CAHs had been a concern for Hyun and other stewardship advocates. In May, members of the Presidential Advisory Council on Combating Antibiotic Resistant Bacteria wrote a letter to Department of Health and Human Services Secretary Alex Azar urging immediate finalization.
Sep 26 CMS fact sheet
Sep 26 Updated CMS CoP document
May 3, 2019, CIDRAP News story "Experts urge approval of hospital antibiotic stewardship requirement