By Allison Shelton and Beth Anne Jackson, Brown & Fortunato, P.C.
On March 5, 2019, the Centers for Medicare and Medicaid Services (CMS) issued new guidance relating to “Immediate Jeopardy” (IJ) determinations. The instructions for such determinations that had been in place since 2004 in Appendix Q of the State Operations Manual were overhauled by CMS. Appendix Q guides surveyors in the determination of IJ situa
tions, which is the most serious citation that may be made during a survey.
There are three types of surveys under Medicare: certification and recertification surveys; complaint surveys; and validation surveys. Notably, even if a hospital is accredited by the Joint Commission or another organization with deeming authority, the hospital may be subject to a complaint or validation survey that focuses on the Medicare Conditions of Participation. During a survey, surveyors may identify standard-level or condition-level deficiencies. Surveyors also determine whether such deficiencies create an IJ situation.
“Immediate Jeopardy” is defined in the Code of Federal Regulations as “a situation in which the provider’s or supplier’s non-compliance with one or more Medicare requirements, conditions of participation, conditions for coverage or certification has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident or patient.” If a surveyor makes an IJ citation during a survey, and the provider does not correct the situation before the surveyor leaves the provider’s premises, the provider will be placed on the 23-day termination track. In other words, the provider’s Medicare enrollment will be terminated in 23 days unless the provider demonstrates that the IJ situation has been corrected. Moreover, correction of the IJ is not enough. Rather, the correction of the IJ situation must be confirmed by the surveyor during a site visit. Thus, it is recommended that a provider correct an IJ situation during a survey before the surveyor leaves the provider’s premises.
According to CMS, the revisions to Appendix Q are intended to “clarify and increase consistency for identifying immediate jeopardy.” This is a lofty goal, especially given the amount of discretion granted to surveyors in the revised instructions. Appendix Q now includes an Immediate Jeopardy Template (the “Template”) that must be completed by surveyors and furnished to providers at the time of an IJ determination. While the Template is intended to help standardize the process, surveyors continue to have considerable discretion in issuing IJ determinations. Appendix Q even instructs surveyors to “use[ ] their professional judgment” in identifying an IJ situation.
To complete the Template, surveyors must document reasons for the following three conclusions. First, the surveyor must conclude that the provider “failed to meet one or more federal health, safety or quality regulations.” To complete the Template for this conclusion, surveyors must identify the regulatory tags with which the provider failed to comply and summarize the issues that led to the surveyor’s finding of noncompliance.
Second, the surveyor must conclude that the provider’s noncompliance with applicable regulations “caused or created a likelihood that serious injury, harm, impairment or death to one or more recipients would occur or recur.” In Appendix Q, CMS indicates that the provider’s noncompliance needs to be a contributing factor, but not the sole factor, that led to or created the risk of harm. In making this conclusion, the surveyor must identify the harm that occurred or that is reasonably expected to occur. CMS explains in Appendix Q that serious physical harm or the risk of such harm is not the only type of adverse outcome that will support an IJ determination. Adverse “psychosocial outcomes (e.g., change in mood or behavior)” that arise from or are expected to arise from the provider’s noncompliance may also form the basis of an IJ determination.
CMS indicates in Appendix Q that a high mathematical probability of harm occurring is not required for the surveyor to make the second conclusion that is required by the Template. According to CMS, “[i]n extraordinary circumstances, the provider/supplier creates conditions that are incredibly dangerous to the health and safety of recipients at risk such that immediate action is imperative, despite a relatively low mathematical probability of the adverse outcome occurring. For example, a hospital has no system to prevent infant abduction. Although the mathematical probability may be relatively low, the risk that an infant could be abducted is intolerable, and demands immediate attention.” In such situations, surveyors may issue an IJ citation, even though the risk of harm is low.
Finally, to issue an IJ determination, the surveyor must conclude that immediate action is needed to correct the noncompliance. Surveyors must provide an explanation for this conclusion in the Template. Further, a surveyor must furnish the completed Template to the provider when the surveyor communicates the IJ citation. Thereafter, the provider is required to prepare and implement a written IJ removal plan to avoid termination from the Medicare program. The IJ removal plan should detail the immediate action steps that the provider will take to address the IJ situation. Note that the IJ removal plan is different from and in addition to the response the provider will prepare to the surveyor’s CMS 2567 report.
In the event a provider receives an IJ citation, the provider should take immediate action to prepare and implement a written IJ removal plan. The removal plan must adequately address the IJ situation in order for the provider to avoid termination from the Medicare program.