ARTICLE
28 March 2019

CMS Clarifies Immediate Jeopardy Guidance

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Holland & Knight

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When a surveyor cites "immediate jeopardy" at a provider, supplier or laboratory's location it can lead to serious consequences, including potential fines and termination from federal healthcare
United States Food, Drugs, Healthcare, Life Sciences
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Shannon Britton Hartsfield is a Partner in Holland & Knight's Tallahassee office.

When a surveyor cites "immediate jeopardy" at a provider, supplier or laboratory's location it can lead to serious consequences, including potential fines and termination from federal healthcare programs. On March 5, 2019, CMS issued guidance for the first time in about 15 years, substantially revising guidelines that state inspectors should follow when citing immediate jeopardy. Immediate jeopardy citations are supposed to be reserved for situations where patients are likely to suffer or have suffered "serious injury, harm, impairment or death" as a result of noncompliance with federal health and safety requirements.

A finding of immediate jeopardy involves "the most severe and egregious threat to the health and safety of recipients." The key changes to Appendix Q of the State Operations Manual include the following:

  • Under the prior guidance, immediate jeopardy could be cited when there was a mere "potential" for serious harm. Under the new standard, when patients have not already been seriously harmed, the noncompliance must be something that "creates a likelihood (reasonable expectation)" that such harm will occur. The mere potential for uncorrected noncompliance to cause harm is not sufficient for an immediate jeopardy citation.
  • Immediate jeopardy may be cited for any noncompliance that meets the standard. Culpability is no longer required.
  • Adverse physical consequences are not always required. The guidance allows a finding of immediate jeopardy when a reasonable person could be expected to experience serious mental or psychosocial harm as a result of the noncompliance.
  • There are no situations that will automatically lead to immediate jeopardy. The guidance clarifies that the decision to impose this citation must be arrived independently.
  • The guidance has subparts that focus on particular, immediate jeopardy concerns for clinical laboratories and nursing homes.
  • Surveyors now have a template to follow to make sure that providers, suppliers and laboratories receive transparent and timely communication regarding immediate jeopardy citations.

The new guidance is effective immediately and all surveyors are expected to be trained on the new provisions by March 22, 2019.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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