Regulatory interpretation and guidance is an important topic to understand in the healthcare industry because healthcare is constantly changing and organizations need to stay up to date to remain compliant.
In March of 2019, Centers for Medicare and Medicaid Services (CMS) issued a memo, revised guidance, and an administrative tool for Immediate Jeopardy (IJ). Immediate Jeopardy is a situation where an organizations non-compliance with the regulations has placed the health and safety of patients at risk for injury, harm, impairment or death (CMS, 2019).
The presence of immediate jeopardy is not dependent on actual harm having occurred; it can be present if harm is likely to occur without immediate intervention.
The presence of IJ is assessed by state survey agencies during annual and complaint certification surveys for CMS. The three components that must be present for immediate jeopardy to exist are noncompliance, adverse outcomes, and need for action. The presence of IJ requires an organization to implement immediate corrective action. Failure to correct IJ can result in civil monetary penalties, ban on admissions, and loss of federal certification.
It is important for healthcare facilities which are CMS certified to understand how IJ is interpreted, identified and remedied. In IJ situations where harm has not yet occurred but is “likely to occur”, subjective interpretation can cause differences of opinion between state survey agencies and healthcare facilities. CMS implemented the 2019 updated guidance and tool to address provider concerns regarding inconsistency within and across state survey agencies.
The guidance for IJ is found in Appendix Q of the State Operations Manual (SOM). There are four regulatory definitions of IJ with variations based on facility type, although all contain the core components (CMS, 2019).
- The Standards for Payments to Intermediate Care Facility/Individuals with Intellectual Disabilities and Nursing Facility is found at 42 CFR § 442.2.
- The Provider Agreements and Supplier Approval is found at 42 CFR § 489.3.
- The Survey and Certification of Long-Term Care Facilities is found at 42 CFR § 488.301.
- The Laboratory Requirements is found at 42 CFR § 493.2.
CMS operates under a transparent communication concept by providing all regulations, survey agency guidance, and memos to the public. The information used to train state survey agencies is available for healthcare facilities to help them understand and prepare for the process and outcomes. Prior to issuing new regulations and guidance, CMS conducts provider calls and workgroups to engage healthcare providers and obtain feedback on proposed changes.
IJ is a situation that is determined by the state survey agency for oversight activities, but this does not preclude a facility from conducting its own analysis of events and correcting and reporting accordingly. The requirements and timeframes to report harm, death, and near miss events is dependent on facility type and state and federal regulations.
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Centers for Medicare & Medicaid Services. (2019). Appendix Q: Core Guidelines for Determining Immediate Jeopardy. State Operations Manual (cms.gov)