The normal process doesn't make much news or generate big court cases, but it's interesting to see how it can work successfully.
In July 2016, CMS released a special standalone rulemaking specific to a proposed requirement for antibiotic stewardship programs at US hospitals.
For background see here and here and here. Remember that antimicrobial resistance and better controlled use of antibiotics are major national and global health priorities.
Google helps us reconstruct some back-story.
In June 2014, the Infectious Diseases Society of America (IDSA), along with the Society for Healthcare Epidemiology of America (SHEA), sent a 20 page letter to CMS asking them to create a "condition of participation" for hospitals that they must have formal antibiotic stewardship programs. See the letter online here.
Back to 2012
The letter describes multi stakeholder consensus workgroups that go further back, to 2012, and helped support creation of the 2014 request.
Forward to 2016
Fast forward 24 months, and CMS produced the hospital rule proposal on June 16, 2016 (81 Fed Reg 39448-39480, CMS-3295-P), here. Comment docket here. 201 comments were submitted. I've put about a dozen comments in the cloud as a zip file, highlighting "major" ones with XXX in the file name, here. Interestingly, whereas IDSA and SHEA submitted a joint letter in 2014 requesting the rule, it looks like they commented in 2016 three times: as a joint letter, as a single IDSA letter, and as a single SHEA letter. Other major groups like AHA commented (see zip file).
And Today: 2017-2018
- CMS hasn't finalized the rule yet; one might expect that at 6-12 months, but the agency has up to several years. Perhaps it was viewed as excess regulation by the new administration; perhaps it's in somebody's inbox for sign off.
- Meanwhile, Joint Commission has created guidelines for its hospital accreditation process to help fulfill "best practices" for having an antimicrobial stewardship committee. See JC webpages starting here.
- There's also a February 2018 article (by Cornell authors Kapadia et al.) in the JC journal, here; open access.
- A quick search of Pubmed for "antimicrobial stewardship programs" has over 400 hits, here.
- There's a Presidential Council of advisors here. (See various work products; the next meeting is May 16).
- CDC is involved here.
- Lots of stuff at IDSA, enter the webpages here.
- Based on SSA 1871, the proposed rule issued in June 2016 will expire unless finalized.
I could go on, but the point is, if you view the center of the wheel as the CMS proposed rule in 2016, you can quickly find several years of predecessor and follow-up events that are part of understanding what CMS is thinking.
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Not directly related to CMS rulemaking pathways, but see an April 2018 CDC presentation on the ongoing threat of microbial resistance, here here here. The public health issues continue even if the bureaucracy stalls.