Never events in hospitals depend on patient risk

Originally published in MedPage Today

by John Gever, MedPage Today Senior Editor

Occurrence of some so-called “never events” in hospitals may depend partly on unmodifiable risk factors such as patient characteristics, undermining the rationale for denying Medicare payment for their treatment, researchers said.

Never events in hospitals depend on patient risk Analysis of some 890,000 surgeries performed in 1,368 hospitals showed that patient age and pre-existing conditions such as weight loss and chronic renal failure greatly increased the risk of “never event” complications including surgical site infections and decubitus ulcers, reported Donald E. Fry, MD, of the consulting firm Michael Pine and Associates in Chicago, and colleagues.

Rates of such complications also varied dramatically by the type of procedure, the researchers indicated in their report, published in the February issue of Archives of Surgery.

Colon resection appeared particularly vulnerable to “preventable” complications. It was associated with C. difficile enterocolitis, methicillin-resistant Staphylococcus aureus infections, surgical site infections, and decubitus ulcers with odds ratios of 2.4 to 21.3 relative to the least risky procedures, the researchers found.

Other procedures were associated with relatively high rates of certain complications as well.

Fry and colleagues argued that the findings demonstrate the unfairness of Medicare’s policy, increasingly followed by private insurers as well, to deny all reimbursement for costs associated with treating “never events.”

“Calling these complications never events and refusing to pay for their treatment may advantage high-quality caregivers, but it also will penalize providers that care for the most vulnerable patients or that perform procedures with higher-than-average risk,” the researchers wrote.

The list of Medicare’s “never events,” first implemented in 2008, includes overt mistakes such as wrong-site surgeries, objects left in the patient after surgery, and transfusing the wrong blood type.

But it also includes a variety of other complications that may not be entirely preventable. In addition to decubitus ulcers, MRSA, C. difficile, and surgical site infections, the list covers:

* Falls in the hospital
* Catheter-associated urinary tract infections
* Catheter-associated vascular infections
* Mediastinitis after coronary artery bypass graft (CABG)
* Inadequate glycemic control
* Deep vein thrombosis and pulmonary embolism
* Drug-induced delirium
* Post-operative pneumonia

Fry and colleagues analyzed claims data compiled from the Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample from 2002 to 2005 of adult patients who had one of five specific procedures: colon resection, coronary artery bypass grafting, total hip replacement, abdominal hysterectomy, and aortofemoral bypass.

The data included such patient factors as comorbidities, age, and gender, as well as hospital variables.

Statistical tests were performed to yield C-statistics for associations between these parameters and eight “never event” complications: MRSA, C. difficile, and surgical site infections, mediastinitis after CABG, catheter-associated vascular and urinary tract infections, post-operative pneumonia, and decubitus ulcers.

Including the hospital as well as patient variables, C-statistics for all eight complications exceeded 0.75, indicating that the variables were significantly associated with rates of these events.

Removing the hospital variables from the equations decreased the C-statistic values, but for six of the eight complications they remained above 0.65, suggesting that patient and procedural factors remained important influences on complication rates.

Only mediastinitis after CABG surgery and catheter-associated urinary tract infections had C-statistics below that cutoff when hospital variables were removed, the researchers found. They noted that the limited data in the claims records meant that some unmeasured patient and procedural factors could still have influenced risks of these complications as well.

For each of the eight complications, certain patient factors were associated with substantially increased risks.

Older age was particularly common in this regard, as were malnutrition and weight loss and chronic kidney failure. Odds ratios ranged from 1.8 for emergency admission as a risk factor for C. difficile enterocolitis to 16.4 for malnutrition and weight loss as a predictor of intravascular device infection.

Aortofemoral bypass procedures increased the risk of five complications — C. difficile and MRSA infections, post-operative pneumonia, intravascular device infections, and decubitus ulcers — with odds ratios ranging from 2.3 to 11.9 compared with abdominal hysterectomy.

That the inclusion of hospital variables increased the C-statistic values “supports the contention that achievable improvements in quality of care can reduce the incidence of these complications,” Fry and colleagues emphasized. “Creating financial incentives to reward hospitals with better outcomes is good public policy.”

But flat denial of reimbursement for such complications is not the way to go about it, they argued, calling it “counterproductive.”

“Most hospital-acquired complications cannot be eliminated entirely by adherence to current best practices,” they wrote. “To recognize this fact, payment to cover the cost of caring for potentially avoidable complications should be based on empirically derived rates and costs of complications for providers who deliver documented high-quality care.”

In particular, Fry and colleagues advocated what they called “risk-adjusted warranties” that take account of providers’ degree of control over complications in determining financial rewards and penalties.

Under this system, providers would receive a warranty payment to cover costs of treating theoretically preventable complications that, statistically, are bound to occur even with the best-quality care. The amount would be calculated by multiplying the probability that a complication will occur with high-quality care by the predicted average cost of treating it.

Providers would then be responsible for the costs associated with all such complications that occur, Fry and colleagues explained.

Such a system would eliminate the financial incentives for “cherry-picking” patients, they contended. “Properly calibrated risk-adjusted warranties will not create financial incentives to deny care to high-risk patients and to specialize in low-risk procedures.”

In an invited critique accompanying the report, Jana B.A. MacLeod, MD, of Emory University in Atlanta, agreed that risk adjustment is a better approach than the one taken by the Medicare system.

“This study provides an evidence base to discuss whether unconditional preventability of complications, even in the environment of evidence-based treatment guidelines, actually exists,” MacLeod wrote.

“In our attempt to eliminate the avoidable, we cannot allow the public and private health care funding groups to punish us for the inescapable.”

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