BERKELEY, CA (UroToday.com) - Recent changes within the health care environment have focused on patient safety and quality of care, with a priority on the monitoring and tracking of relevant metrics. In particular, some of these new changes have resulted in financial consequences for hospitals and physicians when it is determined that the quality of care is below a specific standard. The potential success (or failure) of these initiatives is oftentimes dependent on the execution of the legislation rather than just on the concept itself. Studying the potential impact of new laws in a scientific manner is important for the medical community in order to give feedback to lawmakers on how to ensure that new legislation minimizes unintended negative consequences.
One particular piece of legislation that has created a lot of ‘buzz’ in the medical community is the concept of a ‘Never Event’ (NE). NEs are a list of 10 hospital-acquired conditions that the Centers for Medicare and Medicaid Services (CMS) no longer reimburse for as of 2009 (Table 1).[1] These conditions were created under the following guiding principles from Congress. The conditions needed to be:[2]
- high cost, high volume, or both
- leading to assignment to a higher paying Diagnosis Related Group (DRG) when present
- reasonably preventable through the application of evidence-based medicine
In this recent study, we examined how well the current list of NEs adhered to these above principles in the Radical Cystectomy (RC) population.
The RC population is an ideal cohort to analyze the potential effects of such changes given that these patients are generally older than age 65[3] and had at least one comorbidity.[4] Combining this relatively sick cohort with a long and complex procedure leads to the high morbidity of RC as is evidenced by complication rates ranging from 28% - 64%.[5, 6, 7, 8, 9, 10] By utilizing the Nationwide Inpatient Sample (NIS) we were able to perform well-powered multivariate analyses on a weighted sample of 61 142 RC patients that was a national estimate of all RC cases from 2002 – 2009. Our study found that the occurrence of Never Events was rare with an overall rate of 2.42%. This rate was heavily driven by vascular-catheter associated infections (1.25%) and pressure ulcers (0.89%). The additional NEs occurred less than 0.10% of the time (Table 1). Using multivariable analysis to control for patient and hospital demographics, we showed that: increasing age, presence of comorbidities, Black and Hispanic race, Medicare or Medicaid insurance, and low hospital RC volume were all predictors of the occurrence of a Never Event. Finally, we showed that the presence of an NE increased LOS (by 15 days), total costs (by $37,000), and in-hospital morality (8.0% vs. 2.2%).
In reviewing the aforementioned guiding principles for Never Events, our analysis suggests that the CMS appears to have successfully selected conditions that adhere to the first two principles. Our analysis clearly shows that the presence of a NE significantly increases the cost to the hospital and health care system. However, it should be noted that none of the conditions were particularly high volume, and, in fact, many were negligible to non-existent. Analyzing whether the complications are ‘reasonably preventable’ is a more complex issue. On one hand, the two most common NEs -- of vascular-catheter associated infections and pressure ulcers -- have documented guidelines for prevention.[11, 12] This observation is supported by our finding that large volume hospitals have fewer NEs suggesting that they are more familiar with these prevention strategies. However, we also show that despite controlling for many hospital demographics, several unmodifiable patient demographics (age, race, comorbidities, payer) are all independent predictors of the occurrence of a Never Event. When taken together, these findings suggest that some NEs may be preventable to a degree with evidenced-based guidelines but may not truly be ‘Never’ events given their propensity to occur in older and sicker patients despite controlling for other factors. This final point is of important significance for large hospitals that take care of sick and complex patients as there is concern that they will be financially punished disproportionately for caring for these patients and may be incentivized to avoid their care. Similar results were found in other surgical specialties.
In conclusion, the findings from our current study, along with findings in other surgical fields, suggest that the CMS has identified several high-cost complications that appear to be at least partially preventable by evidence-based practices. However the data also suggests that some events are not completely preventable and importantly are associated with older, sicker patients. The government should consider allowing for an acceptable percentage of Never Event complications based on a hospitals complexity of their case-mix. Alternatively, they could consider allocating resources specifically to hospitals that treat sicker patients in order to help prevent these complications in a more challenging patient population. Finally, it is critically important that the health care community continue with outcomes-focused research, based on new and future legislation, to provide prompt feedback to the government and promote successful inclusion of new initiatives and avoid unintended negative incentives.
Table 1 (Click thumbnail to enlarge)
References:
- CMS. Hospital Acquired Conditions. Available at: www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/Hospital-Acquired_Conditions.html. Accessed April 18, 2013
- Deficit Reduction Act of 2005, S. 1932, 103d Congress, 1st Session (2006).
- SEER. SEER fact sheet, 2008, vol. 2011. Available at: http://seer.cancer.gov/statfacts/html/urinb.html. Accessed October 10, 2011.
- Piccirillo JF, Tierney RM, Costas I, et al. Prognostic importance of comorbidity in a hospital-based cancer registry. JAMA. 2004;291:2441-2447.
- Stein JP, Lieskovsky G, Cote R, et al. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001;19:666-675.
- Shabsigh A, Korets R, Vora KC, et al. Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology. Eur Urol. 2009;55:164-174.
- Nieuwenhuijzen JA, de Vries RR, Bex A, et al. Urinary diversions after cystectomy: the association of clinical factors, complications and functional results of four different diversions. Eur Urol. 2008;53: 834-842.
- Konety BR, Allareddy V, Herr H. Complications after radical cystectomy: analysis of population-based data. Urology. 2006;68:58-64.
- Konety BR, Allareddy V. Influence of post-cystectomy complications on cost and subsequent outcome. J Urol. 2007;177:280-287.
- Chang SS, Cookson MS, Baumgartner RG, et al. Analysis of early complications after radical cystectomy: results of a collaborative care pathway. J Urol. 2002;167:2012-2016.
- Pronovost P., Needham D., Berenholtz S. et al. An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU. NEJM 2006;355:2725-32
- Lyder C. Pressure Ulcer Prevention and Management. JAMA 2003;289(2):223-226
Written by:
Gregory A. Joice,a Christopher M. Deibert,a, c Max Kates,a Benjamin A. Spencer,a, b, c and James M. McKiernana, c as part of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc... of their research by referencing the published abstract.
a Department of Urology, Columbia University College of Physicians and Surgeons, New York, NY
b Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY
c New York Presbyterian Hospital, New York, NY
"Never events": Centers for Medicare and Medicaid Services complications after radical cystectomy - Abstract
More Information about Beyond the Abstract