In late November 2024, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum to State Survey Agency Directors on revisions to the State Operations Manual, Appendix Q, which provides guidance for surveyors on identifying whether any certified Medicare/Medicaid provider, supplier or laboratory should be cited for immediate jeopardy.

Immediate jeopardy is the most serious deficiency that can be imposed upon a Medicare/Medicaid certified entity and carries with it the strictest sanctions and fines. The memorandum acknowledges that the version of Appendix Q that is being replaced was drafted in 2004, updated in 2019 and is being updated again “to clarify and increase consistency in identifying immediate jeopardy.”

The following are the key updates, among others, that CMS identifies in the memorandum:  

  1. Likelihood of harm replacing potential for harm: In the 2019 version of the Core Appendix Q, it provided that surveyors could cite immediate jeopardy in situations that could potentially cause a recipient of care to suffer serious injury, harm, impairment or death as a result of an entity’s non-compliance with one or more health and safety requirements. Core Appendix Q was revised, as CMS explains in this guidance, to now make clear that to cite immediate jeopardy there needs to be a likelihood, or reasonable expectation, that harm will occur if not corrected.
  2. Culpability is removed: Because, as CMS explains, the regulatory definitions of immediate jeopardy do not require a finding of culpability, this requirement was removed from Core Appendix Q. Instead, the focus in the revised Appendix Q will focus on whether the non-compliance has caused or will cause serious harm. 
  3. Psychological harm: CMS also explains it added a new section to Core Appendix Q so that surveyors can decide whether the noncompliance has caused or is made likely to cause serious mental or psychological harm to recipients. The reasonable person approach is to be used for this determination as to whether a reasonable person in a similar situation would be expected to experience a serious psychological event or outcome as a result of the noncompliance.
  4. Automatic immediate jeopardy: Surveyors also may no longer make automatic immediate jeopardy citations in the revised Core Appendix Q, but CMS explains in the guidance that each immediate jeopardy citation must be decided independently.
  5. New subpart, immediate jeopardy template and training: CMS also provided a new subpart to Core Appendix Q for nursing homes and laboratories since as CMS explains in the guidance, “there are specific policies related to immediate jeopardy for those provider types” and CMS established an immediate jeopardy template on the notification process for surveyors to follow once they have identified an immediate jeopardy. In CMS’s words, this notification process is “intended to increase transparency and improve timeliness and clarity of communication to providers, suppliers, and laboratories.” State Agency and CMS staff who are involved in immediate jeopardy determinations are also required to take a new training to implement these changes to immediate jeopardy.

While CMS notes in this guidance that the changes are effective “immediately,” there is still a watercolor in the revised State Operations Manual, Appendix Q affixed to the guidance, providing that it is an “Advance Copy.” Our team of experienced lawyers and professionals at Norton Rose Fulbright will continue to closely monitor new guidance from CMS related to immediate jeopardy and are available to answer questions and assist Medicare/Medicaid certified entities in preparation for their next survey.



連絡先

Chief Integration Partner, Life Sciences and Healthcare, United States
Senior Counsel
Associate

Recent publications

Subscribe and stay up to date with the latest legal news, information and events . . .