Medicolegal Issues

Never-Event Implications


The Center for Medicare and Medicaid Services (CMS) recently announced federal payor programs no longer reimburses for medical services rendered to treat certain complications of care. Although CMS chose the majority of these complications because they are “reasonably preventable by following evidence-based guidelines,” the national media and patient advocacy groups have adopted the term “never events” to describe them.

Aside from the payment implications, CMS’ new policy affects the liability risk of any person providing inpatient care, regardless of whether a federal payor is involved.

In its press release announcing the new payment policy, CMS stated, “when you enter the hospital for treatment of one medical problem, you don’t expect to leave with additional injuries, infections, or serious conditions that occur during the course of your stay.” Recognizing “some of these complications may not be avoidable,” CMS found “too often patients suffer from injuries or illnesses that could have been prevented if the hospital had taken proper precautions.”

Consequently, “as part of its commitment to improve the quality of care [patients] receive during a hospital stay,” CMS policy is targeted at reducing “hospital-acquired conditions like certain infections, advanced bed sores, or fractures;” and “preventable medical errors, like performing surgery on the wrong side of the body, that should never happen.”

The list of “never events” covered under the CMS payment policy can be organized into three categories: surgical events, medical products and devices, and case management. The following breaks down each category:

To prevent CMS' reimbursement decisions from becoming the functional equivalent of a res ipsa instruction, physicians need to raise the level of precaution they employ against “never event” complications. At the heart of CMS' decision is its statement “never event” complications are “reasonably preventable by following evidence-based guidelines.”

Case Management

  • Stage III and Stage IV pressure ulcers;
  • Air embolism;
  • Manifestations of poor control of blood sugar levels; and
  • Fracture, burns, joint dislocations, and other injuries occurring from falls or other trauma suffered while an inpatient.

Surgical Events

  • Surgery on wrong body part;
  • Surgery on the wrong patient;
  • Wrong surgery on a patient;
  • Retention of a foreign object, such as a sponge or needle, inadvertently left in a patient after surgery;
  • Surgical site infection following a coronary artery bypass graft;
  • Surgical site infection following bariatric surgery;
  • Surgical site infection following certain orthopedic procedures; and
  • Deep vein thrombosis or pulmonary embolism following certain orthopedic procedures.

Medical Products and Devices

  • Transfusion of wrong blood type;
  • Catheter associated urinary tract infection; and
  • Vascular catheter associated infections.

It’s easy to see why some of the complications made the list. Wrong-side surgery or surgery on the wrong patient are the quintessential cases where liability is generally uncontested. There is not much one can do to satisfactorily explain to a patient, or a jury, why a surgeon and surgical team operated on the wrong body part.

In other cases, however, such as fatal pulmonary embolus, death can occur even when a patient has been appropriately managed. In fact, medical literature demonstrates a small percentage of patients will develop deep vein thrombosis or pulmonary embolus even after having received therapeutic doses of heparin.

Reasonable Expectations

In any case involving a “never event,” we expect plaintiffs’ attorneys to argue CMS’ reimbursement determination is tantamount to a finding of substandard care. In other words, plaintiffs’ attorneys will argue a physician acted negligently simply because the patient incurred one of the proscribed complications. It’s a compelling argument because the federal government has essentially concluded these complications do not occur if physicians and hospitals pay attention while providing care.

You may have heard the Latin phrase res ipsa loquitur; it translates to “the thing speaks for itself.” Legally, res ipsa loquitur states a rule of law where a jury must presume a defendant was negligent when a certain type of injury occurs. The burden then shifts to the defendant to prove the injury occurred in the absence of negligence. The res ipsa rule originated in 1863 when a plaintiff was struck by a barrel of flour falling from a second-story window. The barrel caused the judge hearing the case to remark, “It is the duty of persons who keep barrels in a warehouse to take care that they do not roll out, and I think that such a case would, beyond all doubt, afford prima facie evidence of negligence. A barrel could not roll out of a warehouse without some negligence. … [I]f there are any facts inconsistent with negligence, it is for the defendant to prove them.” Thus, res ipsa is grounded in the notion everyone knows barrels aren’t supposed to fall from second-floor windows.

Traditionally, res ipsa applied only in a small class of medical malpractice cases, such as retained objects following surgery. In such cases, jurors are just as capable as medical professionals in understanding someone was negligent. For example, it does not take expert testimony to establish there has been negligence when a surgical instrument is left in a patient. There’s simply no compelling medical reason for a surgeon to leave an instrument in a patient’s abdomen.

In contrast, res ipsa generally has not applied in cases involving pulmonary embolus because the process of thromboembolic disease is beyond the average juror’s understanding and death by pulmonary embolus would not give rise to a presumption of negligence.

Where res ipsa applies, it’s a powerful concept. If res ipsa were found to apply to pulmonary embolus cases, the jury would be instructed it is the duty of a physician caring for a post-surgical patient to take care that the patient does not develop pulmonary embolus. Thus, a jury would begin with the presumption a patient would not develop pulmonary embolus absent negligence. The physician would then be left with the burden to prove otherwise. Given such a charge, it is foreseeable a jury could return a verdict against a physician, even if the physician managed the patient’s care appropriately and ordered appropriate prophylaxis.

Take Extra Precaution

To prevent CMS' reimbursement decisions from becoming the functional equivalent of a res ipsa instruction, physicians need to raise the level of precaution they employ against “never event” complications. At the heart of CMS' decision is its statement “never event” complications are “reasonably preventable by following evidence-based guidelines.” When a condition is only “reasonably preventable,” instead of “absolutely preventable,” a defense lawyer retains the ability to argue some patients will develop the condition even when the care was entirely appropriate.

We believe most jurors understand the inherent difficulties of caring for sick patients, and the risks that exist every time a patient undergoes a surgical procedure. The defense lawyer’s challenge is convincing a jury the patient received appropriate care, notwithstanding the complication.

Because CMS refers to “evidence-based guidelines,” physicians must know and follow the guidelines. The first step is becoming familiar with the complications CMS will deny reimbursement, and then regularly review the available guidelines to identify practices to reduce or eliminate the complication. Re-evaluate and update your practice whenever new information becomes available.

A consistent cycle of evaluating and responding to complications will afford the defense lawyer the ability to argue the physician and hospital complied with “evidence-based guidelines” and the patient’s case represents one of the unfortunate incidents where a patient suffers a complication despite receiving the highest-level of care.

In our experience, many providers initially create good systems, but run into trouble in the follow up. Make sure you respond to new or additional information or methods of practice. Without this follow up, CMS’ reimbursement decisions have the potential to create malpractice liabilities for all inpatient providers. TH

Patrick O’Rourke works in the Office of University Counsel, Department of Litigation, University of Colorado Denver.

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