Monday, June 10, 2019

Brief Blog: CMS Extends Expiration Date for Antibiotic Stewardship Rule

Followup: See an important August 2019 lengthy post by Seema Verma on antibiotic issues; here.

Followup:  Regulation for ASP was finalized in September 2019; here.

In June 2016, CMS proposed that all hospitals have Antibiotic Stewardship Committees meeting certain regulatory standards, as a Condition of Participation.   Like all CMS proposed rules, the rule would expire in 3 years (June 2019) if not finalized.   See contemporary 2016 coverage here.   See proposed rule here.

Some stakeholders in the antibiotics and public health committee have become increasingly concerned that the rule would expire without being finalized, the equivalent of a "pocket veto."  See press here and here.   The Presidential Advisory Council on antibiotics resistance held a special, rapid, off-cycle meeting on April 8, 2019, and all the experts voted unanimously to urge HHS to finalize the rule.  For my meeting report, links, and a transcript here.  Trade news here.


Inside Health Policy reports today that CMS will extend the deadline for consideration of this rulemaking by one year, until June 2020, because of its "complexity."   (Subscription; see headline here.)    CMS also noted that at least some stakeholders had originally (in 2016) asked CMS to delay implementation of the new policy.

Rulemaking was published in Federal Register, 84 FR 27069-70, on June 11, 2019.  Web page here, PDF rule here.

The announcement that the antibiotic stewardship rulemaking is deferred, not dumped, comes as the United Nations and others are working to raise awareness of the global antibiotics crisis.  Last week, as I was traveling through airports, I noticed that the cover story of Newsweek is the antibiotics crisis.


For a comparison of proposed 2016 CMS and Joint Committee standards, see: