On March 5, 2019, CMS issued new guidance for surveyors to identify immediate jeopardy cases. CMS revised the previous version of Appendix Q to clarify and increase consistency for identifying immediate jeopardy and communicating such findings to providers, suppliers, and laboratories.

Immediate jeopardy (IJ) is a situation in which a recipient of care has suffered or is likely to suffer serious injury, harm, impairment or death as a result of a provider’s, supplier’s or laboratory’s noncompliance with one or more Medicare requirements, conditions of participation, conditions for coverage or certification. See 42 CFR § 488.1. IJ represents the most severe and egregious threat to the health and safety of recipients and carries the most serious sanctions for providers, suppliers and/or laboratories.

Appendix Q of the State Operations Manual (SOM) provides guidance to surveyors citing IJ. The recent revision replaces the previous version of Appendix Q and creates a Core Appendix Q to be used by surveyors of all provider and supplier types and laboratories. To cite IJ under the Core Appendix Q guidelines, surveyors must determine that (1) there has been noncompliance with one or more federal health, safety and/or quality regulations; (2) such noncompliance has caused or created a likelihood that serious injury, harm, impairment or death to a recipient would occur or recur; and (3) immediate action is necessary to prevent the occurrence or recurrence of serious injury, harm, impairment or death to one or more recipients. The guidance clarifies that for noncompliance to rise to a level of IJ there must be a “serious adverse outcome” of the noncompliance, which is described as outcomes resulting in a significant decline in physical, mental or psychosocial functioning, which is not solely due to normal progression of a disease or the aging process. See SOM, Appendix Q, Section V, Part B.

CMS made the following key changes in the Core Appendix Q:

• Likelihood Instead of Potential. The previous version of Appendix Q allowed surveyors to cite IJ when there was merely a potential for serious harm. Core Appendix Q clarifies that to cite IJ in situations where recipients have not already suffered serious injury, harm, impairment or death, the nature and/or extent of the identified noncompliance must create a likelihood (defined as a “reasonable expectation”) that such harm will occur if not corrected. To determine that serious harm will likely occur if no corrective action is taken, the Core Appendix Q instructs surveyors to use their professional judgment and to consider the nature and scope of the identified noncompliance, the particular vulnerabilities of the recipients at risk and any other relevant factors.
• Culpability Removed. The previous version of Appendix Q required surveyors to make a finding of culpability to cite IJ. The Core Appendix Q guidance removes this requirement and instead requires just a finding of noncompliance. CMS reasoned that this change is consistent with the regulatory definition of IJ that does not include culpability as an element.
• Psychosocial Harm. The Core Appendix Q instructs surveyors to consider whether noncompliance has caused or made likely serious mental or psychosocial harm to recipients. “Psychosocial” refers to the combined influence of psychological factors and the surrounding social environment on physical, emotional and/or mental wellness. If the psychosocial outcome to the recipient is difficult to determine or incongruent with what would be expected, surveyors may analyze how a reasonable person in the recipient’s position would be impacted by the noncompliance (i.e. would a reasonable person in a similar situation be expected to experience a serious psychosocial adverse outcome as a result of the same noncompliance).
• No Automatic IJ Citations. Under the Core Appendix Q, noncompliance with one regulation that rises to the IJ level, does not automatically raise noncompliance of a related regulation to the IJ level. Surveyors must decide each IJ citation independently. If the surveyor finds that the same incident or facility practice results in multiple violations, the team must be able to articulate how the incident or practice represents a distinct violation of each regulation. Although a comprehensive statement may contain facts illustrating deficiencies of multiple regulations, surveyors may not simply copy and paste from one to another. Even if multiple deficiencies share common facts, surveyors may need to conduct additional investigation to evaluate additional deficiencies thoroughly.

The new guidance also includes subparts to Core Appendix Q that provide guidance specific to long term care facilities and clinical laboratories. See SOM, Appendix Q, Subpart X (Long-Term Care) and Subpart XI (Clinical Laboratories). CMS reasoned that this change was made because there are specific policies related to IJ citations for these specific provider types.

Additionally, CMS added an IJ Template that surveyors must use to document each component of IJ. See SOM, Appendix Q, Subpart XII (IJ Template). If the surveyor makes a finding of IJ, CMS instructs the surveyor to use the IJ Template to convey information to the provider, supplier or laboratory. CMS notes that Form CMS-2567 is still the only form that contains official survey findings and any information on the IJ Template does not reflect an official finding against an entity. CMS indicated that the IJ Template was created to ensure that providers, suppliers or laboratories are notified of an IJ finding as soon as possible, to increase transparency and to improve timeliness and clarity of communications.

Finally, CMS has created an online training program for Core Appendix Q. CMS requires all Regional Office (RO) and State Survey Agency (SA) staff involved in making IJ determinations to complete this training as soon as possible, but no later than March 22, 2019. CMS states that the training is designed to provide RO and SA surveyors, management staff and training coordinators, as well as providers, suppliers and laboratories with the ability to uniformly identify IJ.

The guidance and revised Appendix Q can be found here.