Noncompliance cited as immediate jeopardy (“IJ”) is one of the most severe survey findings for certified Medicare and Medicaid provider entities. According to the Centers for Medicare & Medicaid Services (“CMS”), IJ “represents a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment or death.” Although situations cited at the IJ-level have long been associated with non-acute care surveys involving clinical laboratories, skilled nursing facilities and other long-term care providers, recent IJ citations have expanded beyond those provider types. Acute care hospitals, often to their surprise and dismay, are also becoming more frequent targets of IJ-level citations.

In March 2019, CMS revised the State Operations Manual Appendix Q – Core Guidelines for Determining Immediate Jeopardy to standardize certain procedures for determining an IJ deficiency. CMS made additional, minor revisions to these guidelines in September 2019 (the “Revised Guidelines”). Since these updates were made, acute care providers in CMS regions across the country have received IJ-level citations for alleged noncompliance with certain Medicare Conditions of Participation. A single condition-level deficiency can become the impetus for an IJ citation when the survey team establishes noncompliance with one or more of the federal health, safety and/or quality regulations.

Acute care hospitals need to recognize that CMS will cite IJ when surveyors believe noncompliance warrants such a finding. Importantly, IJ violations may be cited not only when an entity’s noncompliance has caused or is causing serious injury, harm, impairment or death, but also when the noncompliance has made serious harm, injury, impairment or death likely. From a process standpoint, the survey team must gather sufficient evidence through observation, interview and record review to support the IJ citation. The survey team must be able to explain to its supervisor and the CMS Regional Office why the noncompliance rises to the level of the IJ. When IJ is cited, not only is the hospital placed on a Medicare provider termination track, as is the typical course with condition-level noncompliance, but the IJ may also carry fines and penalties.

Key Components of the Revised Guidelines

Under the Revised Guidelines, Surveyors must verify that all three of the following components exist in order to cite IJ:

  1. Noncompliance: The entity has failed to meet one or more federal health, safety and/or quality regulations;
  2. Serious Adverse Outcome or Likely Serious Adverse Outcome: As a result of the identified noncompliance, serious injury, serious harm, serious impairment or death has occurred, is occurring or is likely to occur to one or more identified recipients at risk; and
  3. Need for Immediate Action: The noncompliance creates a need for immediate corrective action by the provider/supplier to prevent serious injury, serious harm, serious impairment or death from occurring or recurring.

The survey team is also asked to identify, to the best of its ability, when the IJ began. The duration of IJ is dependent on the nature and extent of noncompliance and the patients at risk. CMS has also made it clear that a hospital will not be able to defeat a potential IJ citation by claiming that the noncompliant behavior was limited to a single “rogue” employee or other actor, since an entity cannot disown the acts of its employees, operators, consultants, contractors or volunteers.

When an IJ concern is identified, the survey team will document its initial findings on the IJ Template. The IJ Template will be used to convey critical information to the entity. Hospitals should keep in mind that the initial IJ Template prepared by the survey team is subject to review by the survey team supervisor and the CMS Regional Office, and does not reflect official findings against a Medicare provider or supplier; CMS Form-2567 is the only form that contains official survey findings. The IJ Template outlines the three components of the IJ deficiency and provides details on the entity’s alleged noncompliance with each component. Although the IJ Template is merely a preliminary indication of survey findings, it can be used by the provider to begin working on a plan to remove and/or correct the underlying situation that resulted in the IJ. Even if the entity disagrees with the preliminary IJ determination, quickly addressing the noncompliance is critical. Unlike a plan of correction, an IJ removal plan does not need to completely correct all noncompliance; rather, it must ensure that serious harm will not occur or recur. The removal plan must include a date by which the entity asserts the likelihood for serious harm to any recipient no longer exists.

Recommendations

With the recent increase in IJ citations for acute care providers, many of these providers could benefit from involving experienced legal counsel early in the process to assist in evaluating and identifying next steps. Providers are also finding some success in promptly removing and/or disputing an IJ citation. Given the severity of an IJ citation, it is important that providers take immediate actions to correct any identified deficiency. Whenever possible, this action should begin while the surveyors are still onsite at the facility. Such actions may include but are not limited to: (1) identification of the issues that led to the IJ; and (2) immediate actions to remove the actual or alleged noncompliance (e.g., immediately implementing a new process and training to keep patients safe and free from serious harm) that led to the IJ. Once the removal plan is approved, providers can then turn their attention to implementing additional corrective actions and ongoing monitoring to ensure that such measures are effective.

While taking immediate action to address any preliminarily identified deficiency should be the first order of business for hospitals facing potential IJ citations, hospitals that receive IJ Templates should also consider promptly requesting a conference with the survey team supervisor, or even the CMS Regional Office, in order to attempt to resolve surveyor concerns prior to issuance of a final IJ finding on the Form 2567.