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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  • Michael Kirsch, M.D.

    At first, the ‘never events’ concept was marketed as wrong site surgery or leaving a few clamps in the abdomen. Beware of ‘mission creep’. I fear that legitimate complications and adverse events will soon be defined as ‘never events’, reinforcing the public’s misconception that complications are preventable. Is the motivation behind this really only about safety?

  • Primary Care Internist

    Like everything else in life, this is all about one thing: MONEY –

    money for medicare

    money for their recovery audit contractors

    money for trial lawyers

    money FROM doctors and hospitals.

    This will only serve to exacerbate the problems of inpatient care. Just yesterday I admitted a patient to a SNF from a hospital with delirium, dementia, a deep sacral decubitus ulcer, foley draining cloudy urine, and to get ONE MORE DAY of IV antibiotics, transferred rapidly out of a hospital amidst all these things. This type of patient will be like a hot potato between hospitals, snf’s, and the community, with each pointing to the other as the source of a “never” event.

    Some are even mutually exclusive – inpatient falls and drug-induced delirium??? I guess that means for the elderly combative demented acutely-ill patient, we restrain them? For the patient with urinary retention or who needs strict I+O monitoring, no foley but rather straight cath regularly? real unpleasant for the patient, but as long as it doesn’t lead to a never event. Even if the patient will get a UTI anyway, at least it wasn’t due to a foley.

    More of the same nonsense pervading medicine – treat charts instead of patients!

  • Primary Care Internist

    meant “break a hip” not “brake a hip” (sorry).

    also, as far as wrong meds, the push for EMR and computerized order entry will create MANY MANY MANY med errors. Yet medicare is essentially forcing doctors to adopt such systems based on their non-practicing experts. Those of us actually treating patients are in agreement about this.

  • Primary Care Internist

    The growth in incidence of decubitus ulcers, one can argue, is due to the tremendous “improvement” in management of chronic disease e.g. heart disease, resulting in prolongation of life. So we have a whole new growing population of people who require intensive nursing care, who are often bed-bound, demented, etc.

    Didn’t Christopher Reeve die with st.4 bedsores? Did he have suboptimal care?

    The problem with medicare’s “never event” payment policies, and reports like the IOM medical errors report often cited on these blogs, is that they’re devised by politicians and non-clinical doctors who don’t actually treat patients, but stake their whole careers on playing monday morning quarterback.

    If medicare wants to not pay for falls/delirium/hypoglycemia etc., then they need to set up a hotline where I can call one of their “experts” and they can advise me how to manage my elderly demented agitated patient who I know is gonna fall out of bed and brake a hip, despite our best efforts. That way I can document the conversation, enlist their advice as a co-provider, and avoid the monday morning quarterbacking.

  • dud

    Primary Care?

    It is exactly about the money, that is the whole point.
    Trying to incentivize better care through monetary penalties (lack of reimbursement).

    What is your solution to stage 4 decubitus, lap sponges left behind, wrong meds, etc… Just say sorry, nothing is perfect?
    That does not work in any other area of life, nor should it.

    Kind of agree on the falling issue though and how best to define what a “never” event is. The mission creep admonition is a good one.
    That does not change the premise/goal of the concept of not getting paid for things of complications of things is a laudable idea.

  • alex

    What is YOUR solution to stage 4 decubitus? That’s the entire point. If it is a “Never Event”, tell us how to make it never happen. Because nobody who actually provides care has figured out how to make it a never event.

  • joe

    Pressure ulcers occur with the best of care. DVT’s occur with the best of care. Infections in the hospital occur with the best of care. For those of us who actually practice medicine, we all no that these events occur and by definition are NOT never events. By all means, monitor institutions to see if these events occur at greater frequency and address as needed (including fines and education) . But to call them never events, well that is just stupid. then again we are dealing with CMS and IOM where common sense was never a strong point.

  • dud

    Is there a consensus that infected stage four bed sores are not preventible?

    I understand the pushback to trying to define things as “never” which are not. Always and never are dangerous words in most applications.

    The non-medical world, of which I inhabit, seems to run on a premise that financial incentives will be among the best motivators. Perhaps this is not true for medicine.

    However, when things occur to patients which are/should be easily preventible (I’m not trying to include things which are always clear in retrospect) the response should be more than “medicine is complicated” followed by some diatribe on medical liability reform. (which I agree is need by the way)

    It seems there should be some agreement on things that should “almost never” happen. When they do the individuals/system responsible should be analyzed or retrained to minimize the chance of it occurring again.

    What else do you do other than financially penalize? I guess you could give “bonuses” to institutions/providers who have a low frequency of “never” events or exceedingly low infection rates. However, I could easily see unintended ramifications of such a system.

    I guess the thing that is troubling is the hospital getting reimbursed for the multiple surgeries after an sponge which was left behind get infected. Or, a patient with decreased mobility gets a stage four sacral ulcer that gets infected and the tailbone is cut out. I’m not sure there is an industry other than medicine who would think of allowing reimbursement for such consequences of its own making.

  • CounyRat

    The reason patients suffer complications is that they are sick. The sicker they are, the more vulnerable to complications they will be. Yes, money, or the witholding of money, can create incentive. However, it can also create disincentive. The current list of “never events” creates a disincentive to treat the sickest patients, and an incentive to transfer them to other facilities. This nonsence is an inevitable result of the transfer of governance in medicine away from medical practitioners, and into the hands of government agencies staffed by personnel who do not care for the sick. Good intentions do not heal the sick. concientious practitioners, guided by their hard-aquired professional judgement do. However, this fact seems to get lost in discussions of healthcare in the U.S.

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