Wednesday, February 26, 2020

Very Brief Blog: CMS Responds to Hill re Medicare Program's Sepsis Policies

Just a week ago, there were several big-data articles, supported by CMS and BARDA, on the scope and morbidity of sepsis in the Medicare population (entry point here).

Separately, one of the controversies in the academic literature has been around CMS's mandatory measurement of a measure called SEP-1, which has had a conflicting range of positive and negative articles (entry point here; see also PubMed for SEP-1 here.)

In 2020, the House asked HHS to report on its interventions for sepsis and its management of the SEP-1 quality measure.  CMS has now responded.

See the Fiscal Year 2021 CMS Justification of Budget, 346pp, online here.  (This is the mandatory 300 page bedtime reading for Medicare-ologists until the Hospital Rule comes out in April 2020 and the Physician and Outpatient rules come out in June 2020).   CMS's response flags that it may prefer to replace SEP-1 (a complex process measure) with a simpler and more direct outcome measure (such as % survival in sepsis.)

Scrolling head to page 260, here is the House request of CMS, issued last summer:

Sepsis.—The Committee is concerned that sepsis and antibiotic resistant bacteria continue to be leading public health threats that are responsible for a significant number of deaths, as well as rising costs within the healthcare system. According to the most recent data, the national average compliance rate for CMS’s sepsis treatment measure, known as SEP–1, is only 49 percent. The Committee urges CMS to issue a Request for Information to gather views on proposals to modernize and optimize CMS’s current SEP– 1 measure.

The Committee requests an update on these activities in the fiscal year 2021 Congressional Budget Justification.

CMS responds:

CMS agrees that ensuring proper sepsis treatment and antibiotic stewardship is crucial to protecting patients in healthcare facilities and in the community at large.

As stated in CMS’Measure Inventory Tool
( ),
a principle of sepsis care is that clinicians must rapidly treat patients with an unknown causative organism and unknown antibiotic susceptibility. Since patients with severe sepsis have little margin for error regarding antimicrobial therapy, initial treatment should be broad spectrum to cover all likely pathogens. CMS continues to work closely with the Sepsis (SEP-1) quality measure stewards and stakeholders on measure updates.

Since measure inception in 2015, the stewards have made many updates to the measure to improve abstraction, reduce burden, and address concerns raised by clinicians and stakeholders. Measure updates have taken into account evolving clinical practice and current measure specifications align with the Surviving Sepsis Campaign guidelines. The SEP-1 measure is up for National Quality Forum re-endorsement next year and CMS plans to continue close collaboration with the measure
stewards and stakeholders on potential updates and/or changes to the SEP-1 measure.

Additionally, CMS expects to begin working on a sepsis outcome measure and has formed a Technical Expert Panel that will help inform development of this new measure

CMS shares the Committee’s concern about antibiotic resistance. The consequences resulting from misuse of antibiotics are severe, leading to life-threatening infections, adverse drug events, and increasing the prevalence of drug-resistant bacteria. In recognition of the importance of proper antibiotic stewardship, on September 30, 2019, CMS finalized requirements that will ensure that all participating hospitals and critical access hospitals implement antibiotic stewardship programs following nationally recognized guidelines (84 FR 51732). Specifically, the final rule includes important requirements for the implementation of antibiotic stewardship programs as part of the Conditions of Participation for hospitals and critical access hospitals in the Medicare and Medicaid programs. We believe that these antibiotic stewardship programs will provide a critical tool for hospitals and critical access hospitals to use in the fight against the emergence of new strains of antibiotic-resistant bacteria and in the defense of our currently effective antimicrobials.