Editor's note: As this issue went to press, the 21st Century Cures Act was finalized by Congress and signed into law.
Infectious disease groups have successfully lobbied Congress to pass legislation that would fast track development of new antibiotics, improve tracking of drug resistant bacteria and support the national push for antibiotic stewardship.
The sweeping 21st Century Cures Act includes “antimicrobial innovation and stewardship” provisions that were welcomed by groups like the Society for Healthcare Epidemiology of America (SHEA.)
“There is agreement now that we are at a crisis level with the problem of antibiotic resistance,” Lynne Batshon, SHEA director of policy and practice, says in comments before the bill was finalized.
“We believe this bill represents another layer of commitment from the United States. Policy drives change. We think this will help provide additional foundations to ensure that antibiotic stewardship programs and other forces that are needed in order to drive changes in prescribing practices [are in place] to stem the tide of resistance.”
The antibiotic provisions in the Cures Act, which bundles numerous healthcare improvements in a single bill, had passed the House as this issue went to press. It is a separate action than the ongoing discussions by the CMS to require antibiotic stewardship programs as a condition of participation. A final ruling on that is expected to be issued in the near future.
“We are hopeful that CMS is able to finalize that rule as quickly as possible.” Batshon tells Hospital Infection Control & Prevention. “In SHEA’s comments in the docket we urge CMS right up front to finalize the rule by the end of the year.”
The antibiotic provisions in the Cures Act include requirements for the CDC and the FDA to collect and report information on antimicrobial resistance.
“We are hopeful that this might incentivize healthcare IT vendors to make their software more compatible with CDC’s National Healthcare Safety Network (NHSN) [module for] collecting and reporting antibiotic use data,” she says. “Right now, hospitals are fairly limited within that module and it is my understanding that it is due to limitations on many of the software packages. I know those improvements are being made now even as we speak, but I feel that this type of legislation might further incentivize those vendors and better position the CDC to create the demand, so to speak, though NHSN.”
The bill would also require the CDC to distribute educational materials on antibiotic stewardship programs and practices to healthcare facilities, Batshon says.
“The CDC and FDA are already engaging in this and I know that CDC has been distributing materials and has started making data publicly available,” she says. “We believe that this line item in the bill will strengthen this ability.”
A more controversial aspect of the bill would allow the FDA to fast-track new antibiotics under development, and some advocacy groups have cautioned against any efforts to speed up clinical trials. Thus far, the Cures Act has enjoyed bipartisan support and has not been enveloped in the political acrimony of the recent election. However, it is no secret that the incoming administration is generally less likely to view federal regulations favorably than the outgoing one.
“We are hopeful and optimistic that this will remain a bipartisan issue.” Batshon says. “The goal is to get this bill signed within the current administration.”
