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Litigation Impacts of Never Events

Litigation Impacts of Never Events

Health Care Law Note
(May 2008)

Effective October 1, 2008, the Centers for Medicare and Medicaid Services (CMS) will not provide reimbursement to hospitals for certain conditions acquired after a patient's hospital admission.  CMS initially identified eight conditions, termed "never events", for which no reimbursement will be provided.  They are:

  • object inadvertently left in after surgery;
  • air embolism;
  • blood incompatibility;
  • catheter associated urinary tract infection;
  • pressure ulcer (decubitus ulcer);
  • vascular catheter associated infection;
  • surgical site infection-mediastinitis (infection in the chest) after coronary artery bypass graft surgery; and
  • certain types of falls and trauma.

According to CMS, these conditions greatly complicate the treatment of the illness or injury that caused the hospitalization and are reasonably preventable through proper care.

As of April 2008, CMS has proposed expanding its list of "never events" to include:

  • surgical site infections following certain elective procedures;
  • Legionnaires' disease (a type of pneumonia caused by a specific bacterium);
  • extreme blood sugar derangement;
  • iatrogenic pneumothorax (collapse of the lung);
  • delirium;
  • ventilator-associated pneumonia;
  • deep vein thrombosis/pulmonary embolism (formation/movement of a blood clot);
  • Staphylococcus aureus septicemia (bloodstream infection); and
  • Clostridium difficile associated disease (a bacterium that causes severe diarrhea and more serious intestinal conditions such as colitis).

Public comment on the rule proposing this expansion will end June 13, 2008, and a final rule will be issued on or before August 1, 2008.  In addition to CMS, several third-party payors, including CIGNA, have decided to follow CMS's lead.

Whether the list is ultimately comprised of 8 or 17 conditions, "never events" will provide additional challenges to hospitals defending litigation over patient care.  These new litigation challenges may include the following:

  • Arguments that the occurrence of a "never event" is negligence per se (liability based on the violation of a safety statute) or constitutes res ipsa loquitur (the thing speaks for itself).
  • Suggestions that the identification of these occurrences as "never events" is admissible in court as evidence, in the same way that guidelines established by the governing bodies of specialties and subspecialties (such as ACOG), text books and other medical literature, and policies and procedures often are admissible.
  • Attacks on the "same or similar community" standard of care that applies in some jurisdictions, and the protections that that standard offers to hospitals that do not have the technological capabilities or staffing advantages of larger hospitals, such as tertiary care centers and teaching facilities.  Plaintiffs' counsel may argue that the new, "never events" rubric changes that standard, at least with respect to the identified conditions.
  • Efforts to introduce at trial evidence that the hospital was refused reimbursement for these conditions.
  • Attempts to hold hospitals responsible where alleged physician error or other reasons result in later readmission for treatment of such condition(s).

There are strong, sound bases on which to rebut all of these arguments regarding the use of "never events" in litigation.  Our program on May 15 will discuss some of those rebuttal points, and how hospitals can prepare for the litigation impact of this new, "never events" rubric.

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