Perspective

Medicare Nonpayment, Hospital Falls, and Unintended Consequences

Sharon K. Inouye, M.D., M.P.H., Cynthia J. Brown, M.D., and Mary E. Tinetti, M.D.

N Engl J Med 2009; 360:2390-2393June 4, 2009DOI: 10.1056/NEJMp0900963

Article

In 2005, in response to disturbing and widely cited findings by the Institute of Medicine about the prevalence of life-threatening conditions acquired by patients in U.S. hospitals, Congress authorized the Centers for Medicare and Medicaid Services (CMS) to implement payment changes designed to encourage the prevention of such conditions. Under an amendment to the Social Security Act that was enacted on January 1, 2007, the secretary of Health and Human Services was required to identify at least two hospital-acquired conditions by October 1, 2007, that were high-cost, high-volume, or both; that resulted in the assignment of a case to a higher-paying diagnosis-related group (DRG) when they were present as a secondary diagnosis; and that could reasonably be prevented through the application of evidence-based guidelines.

The CMS worked collaboratively with the Centers for Disease Control and Prevention (CDC) and on October 1, 2008, enacted new payment provisions: Medicare will no longer reimburse hospitals for a higher-paying DRG when one of eight selected hospital-acquired conditions develops during the hospital stay. The CMS heralded this move as an effort to align financial incentives with the quality of care, thereby promoting both quality and efficiency.

Hospital falls and trauma were included as one of the eight conditions that, the CMS argues, “should not occur after admission to the hospital.” There is little argument that hospital falls fulfill the first two criteria outlined by Congress — they are high-cost and high-volume, and they result in the assignment of a case to a higher-paying DRG. Some 3 to 20% of inpatients fall at least once during their hospital stay; these falls result in injuries, increased lengths of stay, malpractice lawsuits, and more than $4,000 in excess charges per hospitalization. Thus, hospital falls represent a major patient-safety problem and may complicate a patient's care and treatment. Yet we believe that the inclusion of falls and trauma in this initiative is misguided: it implies both that hospital falls occur as the result of lapses in the health care system and that they can reasonably be prevented through the application of evidence-based guidelines. Most important, their inclusion may have unintended consequences that may cause greater harm than the falls that the initiative is meant to prevent.

Unlike other hospital-acquired conditions that were selected by the CMS, falls are often the result not of medical errors but of diseases, impairments, and appropriate uses of medications and other treatments. Falls and injuries can occur even when hospitals provide the best possible care. Each year, about one third of persons who are 65 years of age or older living in community settings fall at least once; the percentage is 50% among those 80 years of age or older. The CMS's statement that the selected conditions should not occur after admission to the hospital presumes that the conditions were not present before hospitalization — which is not true in the case of falls.

There is no evidence that hospital falls “can be consistently and effectively prevented through the application of evidence-based guidelines.” The authors of the CMS rule acknowledge this fact. In the final rule, as recorded in the Federal Register on August 22, 2007, they note that “although we have not identified specific prevention guidelines for the conditions . . . we believe these types of injuries and trauma should not occur in the hospital and we look forward to working with CDC and the public in identifying research that has or will occur that will assist hospitals in following the appropriate steps to prevent these conditions from occurring after admission.” Although clinical trial results suggest that certain strategies may reduce the risk of falling in community settings, fall prevention in the hospital has been much less studied. What little evidence is available is not encouraging. A recent systematic review suggested that, at best, about 20% of hospital falls can be prevented.1 Moreover, no intervention has yet been shown to reduce the risk of serious injury, the outcome of clinical relevance.

Of greatest concern is that the heightened focus on fall prevention will probably have unintended consequences. If hospitals are scrutinized for the occurrence of falls, the natural tendency will be to focus on such events even at the expense of competing (and perhaps more important) outcomes. Unintended consequences are likely to include a decrease in mobility and a resurgence in the use of physical restraints in a misguided effort to prevent fall-related injuries. Physical restraints have long been used because they are believed to prevent falls. Studies have shown, however, that not only do they not reduce the risk of falls or related injuries, but they are associated with increased rates of complications, including immobility, functional loss, delirium, agitation, pressure sores (which are themselves one of the nonreimbursible hospital-acquired conditions), asphyxiation, and death.2 Moreover, accumulating evidence suggests that restraints may actually increase the risk of falling or sustaining an injury from a fall.3

Manufacturers are taking advantage of the increased interest in fall prevention by marketing new devices. Chairs that are difficult to get out of, enclosed beds, and a wide array of bed alarms — even sock alarms — are meant to circumvent guidelines against the use of traditional restraints. But as devices intended to inhibit free movement, they should be subjected to the same regulations that apply to any other restraints.

We are not advocating that the CMS and hospitals ignore falls; rather, we are sounding a warning for health care providers and policymakers to avoid the temptation to address a complex problem with a simple but wrong solution. As a first step, the CMS should recognize that the goal is ensuring safe mobility, not merely preventing falls, and thus explicitly acknowledge the inherent tradeoff between safety and mobility. Mobility should be considered a vital sign — much as pain now often is, thanks to efforts to heighten care providers' awareness of it and to improve its treatment.

Hospitals must recognize that given the burden of illness, multiple risk factors, and the short duration of hospital stays, multifaceted approaches will most likely be required to prevent falls while maintaining patients' mobility. Indeed, available studies on fall prevention in the hospital suggest that multicomponent interventions implemented by an interdisciplinary team (such as physicians, nurses, rehabilitation therapists, and volunteers or aides) are likely to be the most effective strategies.

Mental-status change has consistently been shown to be a significant contributor to falls in the hospital setting. Therefore, strategies such as the Hospital Elder Life Program (HELP), which has proved to be effective in preventing delirium (a condition that was itself proposed for inclusion on the no-pay list but was eliminated during the public-comment stage), might also be applied successfully to fall prevention.4 Preliminary evidence suggests that the HELP protocols — which address orientation, therapeutic activities, early mobilization, vision and hearing, oral volume repletion, and sleep enhancement — are effective in reducing falls (see tableStrategies Used by the Hospital Elder Life Program (HELP).). Unpublished data from hospitals that use HELP reveal a reduction in falls from 11.4 to 3.8 per 1000 patient-days at one site and from 4.7 to 1.2 per 1000 patient-days at a second site. At 29 hospitals implementing HELP, 95% of staff members reported a reduction in the rate of falls.5 This finding is not surprising: delirium and falls share common risk factors, such as cognitive and functional impairment and immobility.

The inclusion of hospital falls in the new Medicare initiative appears to be premature, at best; at worst, it may be harmful to the very patients it is intended to protect and may ultimately increase the costs of Medicare because of its unintended consequences. In their desire to promote the quality and efficiency of care, the CMS and hospitals must avoid strategies that cause more harm than good. As H.L. Mencken put it, “There is always an easy solution to every human problem — neat, plausible, and wrong.”

No potential conflict of interest relevant to this article was reported.

Source Information

Dr. Inouye is a professor in the Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, and director of the Aging Brain Center, Institute for Aging Research, Hebrew SeniorLife — all in Boston. Dr. Brown is an assistant professor in the Department of Medicine, University of Alabama, Birmingham. Dr. Tinetti is a professor of medicine and epidemiology and public health at Yale University School of Medicine and director of the Yale Program on Aging, New Haven, CT.

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