The Committee on the Quality of Health Care in America was established in 1998 by the Institute of Medicine (IOM), and its first report estimated that between 44,000 and 98,000 Americans die each year as a result of medical mistakes.1 This report attracted considerable attention and increased efforts to improve the safety of health care in this country.
One drawback of the IOM report is that its conclusions regarding the cost of medical errors were not based on a national sample, but were extrapolated from relatively small samples. Another drawback is that the studies upon which its cost estimates are based did not have access to actual insurance claims data for patients who experienced a medical error. This has made it virtually impossible for large health insurers like Medicare to estimate the financial burden they bear due to patient safety problems.
Using a national sample from 1999-2000 (the period the IOM report was released), we examine potentially preventable adverse medical events that occurred over 22,477 Medicare major surgeries across 1,725 hospitals. The sample is large enough that we can estimate precisely the risk-adjusted probability of death and the probability of readmission within 90 days after the potentially preventable adverse medical event. To estimate medical expenditures for the 90 days following the medical injury, we track all of the patient's medical claims for hospital care, inpatient physician care, outpatient care, drugs, and long-term care.
This paper is organized as follows: We introduce the employer claims data and discuss our use of the Patient Safety Indicators developed by the Agency of Healthcare Research and Quality (AHRQ); we then present the results; and we conclude with a discussion of the benefits and cost-savings of reducing medical errors.
Several studies have estimated the cost of injuries related to medical interventions.2–4 All of these studies rely on professional judgment to identify preventable adverse medical events and to estimate the cost of this event by summing the cost of a hospital day, an outpatient visit, and a physician office visit attributed to the event. Yet, because of the time and cost involved in reviewing medical records, studies based on the review of hospital medical records involve a relatively small number of cases.
In particular, Johnson and colleagues2 estimated the cost of medical injuries from the New York Medical Malpractice study, which is based on interviews with 794 individuals who had suffered medical adverse events in 1984; Thomas and colleagues3 estimated the cost of medical errors that occurred in 459 cases in Utah and Colorado hospitals in 1992; and Bates and colleagues4 estimated the cost of adverse drug events using 247 adverse drug events in 207 hospitalized patients in 2 hospitals in Boston over a 7-month time period in 1993.
However, two other studies5, 6 have used large administrative databases to analyze patient safety events. The study by Kalish and colleagues used algorithms to screen 372,680 California hospital discharge abstracts in an effort to identify cases where a medical intervention had resulted in an unintended consequence and where this consequence was determined to have been potentially preventable. Zhan and Miller used the AHRQ Patient Safety Indicators to identify patient safety events among 7.45 million discharge abstracts nationwide. Both of these studies used hospital charge data to estimate the cost of the unintended consequence. However, these studies omitted the cost of services that were not billed by the hospital (e.g., physician services for anesthesia and surgery, and charges for laboratory and imaging services provided by outside facilities) and omitted all subsequent outpatient costs and drug costs.
Our primary source of data was the 2000 MarketScan Medicare Supplement and Coordination of Benefits Database. This database was created by the Medstat Group, Inc., and contains claims data for inpatient care, outpatient care, and prescription drugs for employees, dependants, and retirees over age 65 years in employer-sponsored retiree benefit plans for 41 large employers in all 50 States. The data includes all employer and Medicare coordination of benefits for these enrollees with both employer coverage and Medicare coverage.
We included all medical claims incurred within 90 days after the surgery admission date. We chose a 90-day period since Brennan et al. reported that 50 percent to 70 percent of patients with adverse events recovered within 90 days.7 The unit of observation was any major surgery admission (identified as the “index” surgery) that occurred between July 1, 1999, and October 1, 2000, that did not follow another major surgery admission within the previous 90 days for that patient.
We had a total of 22,477 observations. The surgeries occurred at 1,725 hospitals nationwide. Hospital characteristics were obtained from the American Hospital Association's Annual Survey 1999-2000. County characteristics were obtained from the Area Resource File (Bureau of Health Professions, Health Resources and Services Administration).
Using Patient Safety Indicators (PSIs) developed by AHRQ, we estimated the cost of potentially preventable adverse medical events for patients who have undergone a major surgical procedure. The PSI methodology identifies as potentially preventable adverse medical events only cases in which the evidence that such an event occurred is preponderant. The PSI methodology has recently been well received in the literature.6, 8
We examined 14 potentially preventable adverse medical events defined by the PSI methodology that can occur during major surgery. These 14 adverse events are anesthesia complications, accidental puncture or laceration during the procedure, foreign body left in during the procedure, post-operative hemorrhage or hematoma, wound dehiscence, infection due to medical care, post-operative pulmonary embolism or deep vein thrombosis, iatrogenic pneumothorax, post-operative acute respiratory failure, post-operative sepsis, post-operative physiologic and metabolic derangements, transfusion reaction, post-operative hip fracture, and post-operative decubitus ulcer.
The algorithms used in the PSI methodology identify patient safety problems in administrative discharge data. (You can see the PSI module at the AHRQ Quality Indicator Web site, http://www.qualityindicators.ahrq.gov/.) The algorithms flag potentially preventable adverse medical events based on the International Classification of Disease, Clinical Modification, (ICD-9-CM) codes. We have modified the algorithms to also handle procedure codes that are in the Current Procedural Terminology (CPT-4) format.
The PSI algorithms were developed by the University of California, San Francisco—Stanford Evidence-Based Practice Center (EPC), with collaboration from the University of California at Davis, under funding from AHRQ. The PSIs were carefully designed and reviewed by 11 clinical panels to flag potentially preventable adverse events. This process reduced a list of 200-plus possible indicators down to 14 that were likely preventable. Even so, with administrative data it is still impossible to actually know if the event was preventable. However, any adverse event that was not preventable was likely due to a very severe chronic condition of the patient. Thus, we control for 30 comorbidity conditions of the patient, emergency admission, race, sex, etc. In this sense, we do control for adverse events that are nonpreventable due to comorbidities.
In particular, the EPC found that 5 of the 14 indicators could clearly be “labeled” as medical errors: anesthesia complications, foreign body left in during the procedure, iatrogenic pneumothorax, post-operative hip fracture, and post-operative decubitus ulcer. The full EPC Report9 on how these PSIs were selected, as well as the definition of major surgery, can be viewed at http:// www.qualityindicators.ahrq.gov. More information on the PSIs can be found in Romano et al.10 and Zhan and Miller.6
Our main patient safety variable was modeled as a binary variable that codes a major surgery hospitalization as “1” if at least 1 of the 14 patient safety events occurred during that hospitalization, and codes the surgery hospitalization as “0” if none of the 14 patient safety events occurred. With this model, we then examined (1) expenditures, and (2) patient outcomes associated with potentially preventable adverse medical events. While there may be variation in expenditures and outcomes between each of the 14 PSIs, we did not have a large enough sample to examine each indicator individually. Thus, we pooled all 14 indicators and looked at their average expenditures and outcomes compared to surgeries without any patient safety event.
Linear regression analysis at the discharge level was used to examine the relationship between the occurrence of a potentially preventable adverse medical event during a surgery and the natural logarithm of the total medical claims cost of treating that patient for 90 days after the admission. The natural logarithm of the expenditures was used instead of the absolute level of expenditures because the distribution of the absolute level of expenditures was skewed. We ran five separate regressions, one on each category of costs: (1) total 90-day expenditures, (2) 90-day inpatient hospital expenditures, (3) 90-day inpatient physician expenditures, (4) 90-day outpatient expenditures, and (5) 90-day drug expenditures. Patients who die in the hospital have high inpatient expenditures but no outpatient or drug expenditures. Since the death rate is much higher for patients experiencing potentially preventable adverse medical events, we chose to conduct the 90-day outpatient and drug regressions with the sample restricted to those who did not die during the 90 days.
| Variables | PSI | No PSI |
|---|---|---|
| Emergency admission | 0.051 | 0.082 |
| Female | 0.499 | 0.539 |
| Age | 74.819 | 76.266 |
| Union | 0.253 | 0.286 |
| Fee-for-service plan | 0.748 | 0.726 |
| Preferred provider organization | 0.231 | 0.250 |
| Point-of-service plan | 0.006 | 0.006 |
| Capitated plan | 0.015 | 0.018 |
| Area characteristics (county) | ||
| HMO penetration | 0.247 | 0.273 |
| Media income | $37,609 | $38,683 |
| Hospital characteristics | ||
| Small bedsize hospital | 0.076 | 0.088 |
| Medium bedsize hospital | 0.249 | 0.249 |
| Large bedsize hospital | 0.675 | 0.663 |
| Teaching hospital | 0.508 | 0.512 |
| Public hospital | 0.079 | 0.062 |
| Not-for-profit hospital | 0.857 | 0.895 |
| For-profit hospital | 0.064 | 0.043 |
| Urban hospital | 0.868 | 0.911 |
| Patient chronic conditions | ||
| Congestive heart failure | 0.038 | 0.171 |
| Arrhythmias | 0.077 | 0.217 |
| Valvular disease | 0.027 | 0.091 |
| Pulmonary circulation disease | 0.003 | 0.008 |
| Peripheral vascular disease | 0.026 | 0.062 |
| Hypertension | 0.151 | 0.179 |
| Paralysis | 0.005 | 0.016 |
| Other neurological disorders | 0.019 | 0.061 |
| Chronic pulmonary disease | 0.064 | 0.132 |
| Diabetes | 0.052 | 0.076 |
| Diabetes with chronic complication | 0.009 | 0.133 |
| Hypothyroidism | 0.012 | 0.013 |
| Renal failure | 0.020 | 0.057 |
| Liver disease | 0.003 | 0.003 |
| Peptic ulcer disease × bleeding | 0.003 | 0.008 |
| Aids | 0.001 | 0.001 |
| Lymphoma | 0.004 | 0.007 |
| Metastatic cancer | 0.019 | 0.026 |
| Solid tumor w/out metastasis | 0.068 | 0.085 |
| Rheumatoid arthritis coolagen vas | 0.007 | 0.007 |
| Coagulopathy | 0.007 | 0.020 |
| Obesity | 0.001 | 0.001 |
| Chronic blood loss anemia | 0.004 | 0.009 |
| Deficiency anemias | 0.023 | 0.043 |
| Alcohol abuse | 0.002 | 0.001 |
| Drug abuse | 0.001 | 0.001 |
| Psychoses | 0.004 | 0.012 |
| Depression | 0.002 | 0.006 |
| Sample size | 21,574 | 903 |
PSI refers to a patient safety event occurring.
Next, to control for demand-side factors that may influence the patient's degree of use, we controlled for the type of the health plan, union status, and the median household income for the patient's county. Since we pooled data from 2 years, we also included indicators for each year to control for any time trend.
To control for market characteristics, we included the 1998 county health maintenance organization (HMO) penetration rate. Hospital characteristics include teaching hospitals, rural hospitals, hospital ownership, and hospital bed size. The hospital bed size (small, medium, large) is defined in the Healthcare Cost and Utilization Project (HCUP) National Inpatient Sample documentation (see http://www.hcup-us.ahrq.gov/).
Next, we used a simulation method that is similar to that found in Escarce et al.12 Using each of the five GLM expenditure regressions, we first assumed everyone in the sample had a potentially preventable adverse medical event and predicted their expenditures. We then assumed no one in the sample had a potentially preventable adverse medical event and predicted their expenditures. The difference in the predictions would be the predicted expenditures due to patient safety events. The standard errors of the predicted difference in expenditures due to a potentially preventable adverse medical event were computed using the Delta Method.12, 13
Finally, since long-term care was rarely used by patients in the sample, we predicted long-term care use in two stages: first, the probability of the use of long-term care following a potentially preventable adverse medical event using a logistic regression; second, using a log-link gamma GLM regression on those patients with positive long-term care expenditures during the 90 days to predict long-term care expenditures due to potentially preventable adverse medical events.
Using a logistic multivariate regression at the discharge level, we estimated the probability of dying within 90 days after a surgery in which a potentially preventable adverse medical event occurred. Similarly, we estimated the probability of being readmitted within 90 days after a hospitalization in which a potentially preventable adverse medical event occurred. While the first (index) admission had to be a major surgery, the readmission did not have to be a surgery. Finally, using logistic analysis, we estimated the probability of using long-term care within 90 days after a hospitalization in which a potentially preventable adverse medical event occurred. In all logistic regressions, the robust standard errors were estimated using the Huber/White sandwich estimator and were corrected for clustering at the hospital.
| 90 Day Death Rate | Readmission Rate for Survivors | Long Term Care Use | |
|---|---|---|---|
| PSI | 6.15% | 10.85% | 9.21% |
| No PSI | 1.62% | 8.37% | 5.61% |
| Difference | 4.53%** | 2.48%* | 3.60%** |
| (1.41) | (1.11) | (1.10) | |
| Percentage Difference | 279.63% | 29.63% | 64.17% |
Significantly different from zero at the 99% level.
Significantly different from zero at the 95% level.
| Observations | Total Payment | |
|---|---|---|
| No PSI | 21,574 | $17,319 |
| PSI | 903 (PSI Rate: 4.02%) | $24,317 |
| Inpatient Hospital Payments | Inpatient Physician Payments | Outpatient Payments | Drug Payments | Total Payments | Portion Due To Long Term Care | |
|---|---|---|---|---|---|---|
| PSI | $19,455 | $2,104 | $2,746 | $551 | $24,317 | $631 |
| No PSI | $12,775 | $1,744 | $2,458 | $570 | $17,319 | $486 |
| Payment Difference | $6,680** (1,367) | $360** (119) | $288* (134) | -$19 (24) | $6,998** (1,269) | $145** (68) |
| Percentage Difference | 52.3% | 20.6% | 10.5% | -3.3% | 40.4% | 29.8% |
Significantly different from zero at the 99% level.
Significantly different from zero at the 95% level.
The results on the costs of medical errors presented in the Institute of Medicine's report, To Err Is Human, were based on the small sample, State studies of New York2, 7, 14 and Colorado-Utah.3, 15, 16 These samples were too small to derive cost estimates of patient safety for Medicare patients. To address this problem, in this paper we examined a national sample of elderly Medicare patients with secondary employer coverage.
First, our results provide insight into the composition of medical expenditures 90 days after a potentially preventable adverse medical event. The bulk of the extra expenditures over the 90 days, due to potentially preventable adverse medical events, are inpatient hospital payments. About 5 percent of the 90-day expenditures due to adverse events are physician inpatient payments. On average, about 4 percent of the 90-day expenditures due to adverse events are outpatient payments. Even though all the enrollees had drug coverage from the employer, patient safety events did not result in any extra outpatient drug payments.
This is in contrast to the Utah-Colorado study, where malpractice claims adjustors proposed that 46 percent of the extra lifetime medical costs due to patient safety problems would be outpatient costs.3 This large outpatient composition of expenditures in the Utah-Colorado study is due to the fact that their malpractice claims adjustors attributed 37 percent of the lifetime expenditures on patient safety care to nursing home care. In contrast, we find that only 2.1 percent of the 90-days expenditures due to potentially preventable adverse medical events are attributable to long-term care.
Next, our results provide insight into the magnitude of the 90-day medical expenditures attributable to potentially preventable adverse medical events. We find that patient safety events are responsible for $6,998 in 90-day medical expenditures spent by patients experiencing adverse events. The strength of our study is that we used actual insurance claims (transacted payments) to calculate the costs of a potentially preventable adverse medical event. No other expenditure study uses payments. For example, the studies by Kalish et al.5 and Zhan and Miller6 use hospital charges instead of payment claims, overestimating what was actually paid. Kalish et al. found that major surgeries with complications (a broader category than patient safety event) in 1988 had inpatient charges of $16,023 ($22,188 in 2000 dollars) attributable to the complication.
A second study, the Harvard Medical Practice Study, interviewed 794 patients in 51 hospitals in New York who had been injured during hospitalization in 1984 to ascertain their outpatient medical care use between the hospitalization in 1984 and July 1988.2 They roughly estimated that the lifetime medical costs for these injuries (attributable to injuries and not the illness) were $18,305 per person injured in 1989 dollars ($23,367 in 2000 dollars). However, in that study, much of the costs were based on what the patient or family recalled 5 years after the potentially preventable adverse medical event, with the authors assigning prices to the recalled utilization.
A third study by Thomas et al.3 examined only 265 preventable hospital adverse events that occurred in 1992 in 28 hospitals in Utah and Colorado. They then had 10 malpractice insurance claims adjusters provide an expert opinion on what the lifetime costs of these injuries would be. They found that the lifetime medical costs for these injuries were $17,976 per person injured in 1996 dollars ($20,036 in 2000 dollars). However, in that study, costs were based on claims adjustors' expert opinion of what utilization probably would have occurred, given the medical chart of the medical injury.
Recall that these potentially preventable adverse medical events are based only on 14 measurable PSIs. Thus, there may have been many more preventable safety events (as well as close calls) that occurred but that were not included in our analyses, such as medication errors. In fact, we did not consider drug-related errors, diagnostic errors, and errors in choice of therapy, all of which accounted for 12 percent of surgical errors in the Colorado-Utah study.16 Thus, our expenditure results are an underestimate of all the expenditures attributable to all preventable adverse events.
Nevertheless, these 14 potentially preventable adverse medical events were deemed to be highly preventable by 11 clinical panels, and yet they resulted in excess deaths, readmissions, and expenses for elderly surgery patients with both Medicare and employer coverage. Moreover, our employer data comes from some of the Fortune 500 corporations. Of all Medicare patients in the country, these would be the ones suspected of having top-notch health insurance coverage, with the best choice of doctors and hospitals. Yet, among surgeries alone, these 14 potentially preventable adverse medical events caused 1.1 percent of their readmissions, 9.4 percent of their deaths, and 1.6 percent of their 90-days medical expenditures.
This research was funded by the Agency for Healthcare Research and Quality. The views herein do not necessarily reflect the views or policies of AHRQ, nor the U.S. Department of Health and Human Services. We thank our programmers Linda Andrews of Social and Scientific Systems, Inc., and Yafu Zhao of Coda Research, Inc.
Both authors are affiliated with the Agency for Healthcare Research and Quality, Center for Delivery, Organization and Markets.
Address correspondence to: William E. Encinosa, Ph.D.; Center for Delivery, Organization and Markets; AHRQ; 540 Gaither Road; Rockville, MD 20850; phone: 301-427-1437; fax 301-427-1430; e-mail wencinos@ahrq.gov.
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