We sought to apply a value (outcomes and cost) analysis to extracorporeal life support (ECLS), a relatively rare but very expensive ICU therapy with highly variable outcomes. To address the outcome component of the value approach, we created guidelines for ECLS delivery, and to address the cost component we explored opportunities for more efficient care.
Opportunities exist for variable (as opposed to fixed) cost reduction by increasing efficiency in the delivery of care, and minimizing care outside of locally developed appropriate use guidelines. Reducing ECLS demands on ICU resources allows these resources to be redeployed to patients who are more likely to benefit from them, which also helps the institution financially.
Discussions about end of life preferences should happen long before ICU admission. When this timing is not possible, the discussion should be launched early in the ICU course. Some patients will want aggressive care despite extraordinarily low chance of benefit or survival. When clinicians determine that ongoing therapy is unable to provide outcomes consistent with patient wishes, a discussion with informed and prepared family members can lead to a faster decision about whether to continue or cease ECLS. For costly technology, rapid de-escalation of care can yield significant cost savings provided that the required personnel can be redeployed or otherwise flexed.
Patient and family preferences for more humane and sensitive end-of-life care, if respected, will lead to less intensive use of ICU resources. Patients will have outcomes concordant with their goals and preferences, and society incurs lower costs to help them achieve those preferences.
In appropriate candidates, ECLS does provide good functional outcomes including health-related quality of life. When care is extended to more marginal candidates, outcomes are worse. As has been observed with the provision of other forms of complex care, the appropriate application of ECLS aligns with good financial stewardship.
Change in ECLS reimbursement will incentivize more standardized delivery in efficient models like those discussed in this manuscript.
The use of objective process mapping, clinically relevant costing, and comparing process maps and staffing policies across comparable ECLS facilities in other countries can depersonalize decisions about optimal care process design. Prior to using this approach in our center, attempts to rationalize care tended to devolve into “turf battles.” The value approach highlighted redundancies in care and excessive staffing levels in an objective manner, leading to productive conversations about more efficient approaches to ECLS delivery. The guidelines also served as an objective script on the basis of which clinical decisions could be assessed thereby removing the most extremely contested elements of individual decision-making.
Although the creation of the task force initially generated significant resentment from a few appointed members, a better understanding of their concerns did identify opportunities for program improvement. Once the task force approach became routinized, relationships between team members became more collegial, and disruptive behavior around ECMO became less frequent both during task force work and in a clinical setting.
Given the small volume of patients receiving ECLS (and other types of rare therapies), payers should strongly incentivize the provision of care in centers of excellence which treat a minimum number of cases per year. ECMO does seem to be subject to a volume-outcome relationship; in addition to improved outcomes, large centers can likely benefit from economies of scale and other efficiencies.
Future work should seek to codify a set of patient-centered outcomes to which reimbursement can ultimately be linked.
The U.S spends almost 1% of GDP on Intensive Care Units (ICU). Given this statistic and comparatively lower spending with similar outcomes in other countries, the ICU should be an area where substantial cost savings can be easily achieved. Closer analysis challenges this assumption for several reasons including the inability to reliably determine which patients will survive, and the large — up to 80% in some models — apparently fixed costs of ICU care. These analyses, however, have focused almost exclusively on routine ICU care and not on the care for rare or expensive therapies for which it is not known whether substantial cost reductions can be achieved. We sought to apply a value (outcomes and cost) analysis to extracorporeal life support (ECLS), a relatively rare but very expensive ICU therapy with highly variable outcomes. To address the outcome component of the value approach, we created guidelines for ECLS delivery, and to address the cost component we explored opportunities for more efficient care.
ECLS represents the limit of lifesaving intervention currently available in the ICU. It is one of the most complex therapies provided to patients, in both technical requirements and the number and variety of resources it requires. Patients receiving ECLS have approximately 50% survival rates on average although there is variation depending on the underlying condition. Reimbursement for such care is in flux: in 2018 the Centers for Medicare & Medicaid Services (CMS), drastically reduced payment for percutaneous peripheral placement of a form of ECLS, called Extra-Corporeal Membrane Oxygenation (ECMO). This treatment is used for advanced heart failure, shock, and cardiac arrest or for advanced respiratory failure. CMS reduced reimbursement from more than $100,000 per case to less than $10,000 per case — less than the likely cost of care for most ECLS centers. While protests from providers led the agency to reverse this decision, the incident highlights the importance of understanding costs for ECMO, and for ECLS in general, given the potential for changes in the reimbursement landscape.
ECLS is often used in time-pressured situations that preclude robust evaluation of its appropriateness, especially in the absence of accepted guidelines. Currently available scoring systems provide only limited guidance on which patients will benefit from ECLS, and they do not account for quality-of-life considerations. Even in specific cases, Cedars Sinai clinicians often did not agree about the potential benefits of ECLS . The opinion of the surgeon who implanted ECLS devices tended to prevail, despite concerns voiced by other specialists, such as cardiologists or intensivists for a patient in cardiogenic shock, or the pulmonary and critical care intensivists for a patient with acute respiratory distress syndrome. Surgeons have varying perspectives on providing aggressive interventions: Some are willing to perform a procedure only if the patient has agreed to ongoing aggressive therapy, and others are unwilling to withdraw life-sustaining therapy after a surgical error or complication has occurred, a frequent use of ECLS. These disagreements led to a cycle of conflict among caregivers and confusion among families, as clinicians communicated different opinions about the potential for an acceptable outcome from ECLS. The conflicting advice undermined trust and made it difficult to stop ECLS even when benefits were unlikely.
Hospital leadership hoped that a consensus-driven approach to providing ECLS would eliminate the uncoordinated and seemingly excessive — and at times, non-beneficial — use of the technology. They also believed that the process of creating a value model for the therapy could later be extended to less complex or expensive ICU therapies. While the primary focus of the work was creating appropriate use guidelines for ECLS, financial concerns necessitated creating a clinically relevant cost model for ECLS care. The hospital sought to determine whether costs could be reduced through both optimizing the efficiency of ECLS care and using it only when appropriate.
Cost model: We applied time-driven activity-based costing (TDABC) to quantify the hospital’s costs for providing ECLS. TDABC, used in many other recent studies of hospital costs, estimates the costs of a given clinical service by combining information about the process of patient care delivery (specifically, the time and quantity of labor and non-labor resources needed to perform each activity) with the unit cost of each resource used to provide the care.
The task force used the TDABC model to calculate the cost of each ECLS case between 1 January 2016 and 30 April 2017 (110 patients).(A few patients who were still on ECLS after 30 April 2017 were excluded from the analysis.) The project team followed the procedures described by Kaplan-Porter to implement TDABC. It constructed ECLS process maps by conducting staff interviews and observing actual care delivery in the ICU. (Figure 1) It calculated a capacity cost rate, measured as $/min, for each resource used for ECLS. The total cost of each ECLS case was calculated by multiplying together the unit costs and resource quantities and summing across all resources used.
Guideline development: Hospital leadership created an interdisciplinary task force to develop guidelines for patients and their families when ECLS was the only medical option. The task force focused on Extra Corporeal Membrane Oxygenation (ECMO), used for severe cardiac and/or respiratory failure. The task force drew upon information from the Extracorporeal Life Support Organization, peer reviewed literature on ECMO outcomes, and opinions from experienced clinicians. It eventually decided that during the first three weeks of ECMO, the therapy should be stopped if four or more organ systems failed, and, after three weeks, if three or more organ systems failed, though the task force included a process by which a patient could be exempted from these criteria.
In developing the guidelines for starting ECLS, the task force placed its emphasis on whether the provision of ECLS was consistent with a patient’s minimally acceptable outcome, maximally acceptable burden, and relative likelihood of achieving either. For example, a patient who stated a minimally acceptable outcome of rigorous physical activity and functional independence, but who would require an amputation for limb ischemia and a total artificial heart after separation from ECLS, would not be considered to have goals consistent with either ECLS initiation or, if already initiated, ongoing provision of ECLS. Based on this determination, treatment would not be considered appropriate at our institution. Alternatively, a similar patient who stated a minimally acceptable outcome to interact with children and grandchildren, regardless of how much assistance she needed, would be considered to have goals consistent with initiating and continuing ECLS.
All cases were reviewed by ECLS leadership to determine which cases were appropriate according to the new hospital guidelines.
- Key members of the Hospital ECMO Task Force:
- Medical Director of Cardiac Surgery ICU
- Surgical Director of Cardiac Surgery ICU
- Director of Health Care Ethics
- Cardiac Surgeons credentialed to place patients on ECMO
- Mechanical Circulatory Support Coordinator
- Three members of the hospital human-centered design team
Of the 110 patients in the studied group, there were 10 whose care was determined to be outside of the appropriate use guidelines developed by the task force. The task force performed implicit and explicit review of these cases to assess quality of care. Explicit review relies on pre-specified objective criteria to assess the appropriateness of care. Implicit review relies on an expert reviewer’s opinion and experience, which may take into account subtleties that aren’t captured by the objective criteria. The review process involved a clinical presentation of each case with the core members of the ECLS Task Force present. Each case was discussed, and the task force formed a consensus opinion about appropriateness. Notes were added to each case based on the discussion and common themes were identified.
Of these 10 cases, five had commercial insurance and five had government payers. Consistent with national trends, government payers reimbursed significantly less than commercial payers. However, there was considerable variation in actual reimbursement per patient for each type of payer. In one government payer case, total actual reimbursement was far below the hospital’s costs for treating that patient, and in three government payer cases net income was within 2% of estimated costs — close enough that if the costing were slightly too low, the hospital lost money on these cases as well.
The internal cost estimates for the 86 days of care received by these 10 patients outside of institutional appropriate-use guidelines is confidential to the hospital. However, as a reference, a recent Dutch analysis reported that the mean total hospital costs for ECMO were €106.263 per patient ($116,746) with a mean length of ICU stay of 18 days and an in-hospital mortality of 68%. In this Dutch data set 52% of the total costs arose from hospital nursing days and 11% from direct procedure-related extracorporeal life support costs. In another study, average charges (not costs) per day were $40,588 ± $3099 with an overall length of stay of 18.3 ± 1.3 days. Care for ICU patients who die has been shown to be more expensive than for those who live highlighting the cost consequences of the indiscriminate use of technology for patients unlikely to survive.
Where to Start
- To apply a value perspective to the treatment of expensive, rare conditions, or those with highly variable outcomes, carefully define the condition and challenge to be addressed, and solicit support from senior leadership, highlighting the combined opportunity for improving outcome and patient experience while reducing cost.
- Have senior leadership appoint and authorize a respected interdisciplinary collaborative team to develop and build consensus for locally relevant guidelines to improve the appropriateness of care.
- As part of this effort, both implicit and explicit review of cases should be undertaken. Explicit review relies on pre-specified objective criteria to assess the appropriateness of care. Implicit review relies on expert reviewer’s opinion as opposed to objective criteria. These approaches were commonly used before risk adjustment techniques became widespread, and they continue to have a role in evaluating the outcomes of rare conditions where it may be difficult to adequately risk-adjust patients.
- Use time-driven activity-based costing to identify relevant clinical costs and opportunities to be considered for process improvement.
The authors thank Jeremy Kahn, MD, MS for insightful comments on drafts of this manuscript. We acknowledge the helpful perspectives obtained from collaboration with Alain Combes, MD, PhD, and Marc de Chambrun, MD, MSc at Hôpital La Pitié–Salpêtrière, Sorbonne Université, Assistance Publique–Hôpitaux de Paris, Paris, France and Vin Pellegrino MBBS, FRACP, FCICM at The Alfred Hospital, Monash University School of Public Health and Preventative Medicine, Melbourne, Australia. Additional thanks are due to the administrative, clinical, and leadership teams at Cedars-Sinai Medical Center who supported this work.