COST ANALYSIS Bending the Cost Curve—Establishing Value in Spine Surgery Scott L. Parker, MD∗ Silky Chotai, MD∗ Clinton J. Devin, MD∗ Lindsay Tetreault, PhD‡ Thomas E. Mroz, MD§ Darrel S. Brodke, MD¶ Michael G. Fehlings, MD, PhD|| Matthew J. McGirt, MD# ∗ Department of Orthopedics Surgery and Neurological surgery, Vanderbilt University Medical Center, Nashville, Tennessee; ‡ Spinal Cord Injury Clinical Research Unit, Krembil Neuroscience Centre, University Health Network, Toronto, Canada; § Center for Spine Health, Department of Neurosurgery and Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio; ¶ Department of Orthopedics, University of Utah School of Medicine, Salt Lake City, Utah; || Division of Neurosurgery, University of Toronto, Toronto, Canada; # Department of Neurological Surgery, Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina Correspondence: Mathew J. McGirt, MD, Department of Neurological Surgery, Carolina Neurosurgery and Spine Associates, Charlotte, NC. E-mail: [email protected] Received, August 16, 2016. Accepted, October 31, 2016. C 2016 by the Copyright Congress of Neurological Surgeons BACKGROUND: As publically promoted by all stakeholders in health care reform, prospective outcomes registry platforms lie at the center of all current evidence-driven value-based models. OBJECTIVE: To demonstrate the variability in outcomes and cost at population level and individual patient level for patients undergoing spine surgery for degenerative diseases. METHODS: Retrospective analysis of prospective longitudinal spine registry data was conducted. Baseline and postoperative 1-year patient-reported outcomes were recorded. Previously published minimal clinically important difference for Oswestry Disability Index (14.9) was used. Back-related resource utilization and quality-adjusted life years (QALYs) were assessed. Variations in outcomes and cost were analyzed at population level and at the individual patient level. RESULTS: A total of 1454 patients were analyzed. There was significant improvement in patient-reported outcomes at postoperative 1 year (P < .0001). For patients demonstrating health benefit at population level, 12.5%, n = 182 of patients experienced no gain from surgery and 38%, n = 554 failed to achieve minimal clinically important difference. Mean 1-year QALY-gained was 0.29; 18% of patients failed to report gain in QALY. For patients with 2-year follow-up, surgery resulted in 0.62 QALY-gained at average direct cost of $28 953. A wide variation in both QALY-gained and cost was observed. CONCLUSION: Spine treatments that on average are cost-effective may have wide variability in value at the individual patient level. The variability demonstrated here represents an opportunity, through registries, to identify specific care that may be less effective, and refine patient-specific care delivery and indications to drive overall grouplevel treatment value. Understanding value of spine care at an individualized as well as population level will allow clinicians, and eventually payers, to better target resources for improving care for nonresponders, ultimately driving up the average health for the whole population. KEY WORDS: Value, Spine, Surgery, Cost, Cost-effectiveness, QOD, Spine registry, Patient-reported outcomes Neurosurgery 80:S61–S69, 2017 DOI:10.1093/neuros/nyw081 T he health care expenditure in the United States (US) is on an upward trajectory and clearly unsustainable.1-3 According to the Centers for Medicare and Medicaid Services, the health spending is projected to grow 1.3 parentage points faster than gross ABBREVIATIONS: GDP, gross domestic product; EQ-5D, EuroQol-5D; HCRU, healthcare resource utilization; MCID, minimum clinically important difference; ODI, oswestry disability index; PROs, patient-reported outcomes; QALYs, qualityadjusted life years; QOD, quality outcome database NEUROSURGERY www.neurosurgery-online.com domestic product (GDP) per year, resulting in projected health share of GDP as high as 20% by 2025. 1,4 Spine degenerative pathologies and associated disability is highly prevalent and an economic burden.5-9 The estimated direct costs for treating these patients range from $80 to 100 billion.6,10-13 In an effort to curb escalating costs, the Patient Protection and Affordable Care Act and Centers for Medicare and Medicaid Services have adopted a pay-for-performance value-based purchasing.14 Health care value is measured by comparing quality delivered against cost incurred (benefit/cost) and is optimally examined in the VOLUME 80 | NUMBER 3 | MARCH 2017 Supplement | S61 PARKER ET AL context of various consensus-based health care outcomes.15-17 The numerator “benefit” is defined by the efficacy of the treatment in terms of outcomes following intervention. The denominator of the question cost is defined as dollar spent for the intervention from the patient, provider, and societal perspectives.17 Therefore, in order to ultimately bend the cost curve and improve the value of spine surgery, the effectiveness of a surgical procedure as it pertains to patient outcomes and quality of life measures must be closely defined in the real-world setting. Prospective registries have demonstrated their value to efficiently capture patient-reported outcomes (PROs) data across multiple centers, achieving necessary statistical power to assess true value of spine care at both the population level and at the individual patient level.18-20 Prospective registries measure safety, quality, and effectiveness of procedures in real-world health care delivery settings that are not limited, and biased by the simulated research setting and structure criteria of a clinical trial. It is for these reasons that registries represent the “next disruptive technology” in clinical research.21 Furthermore, the real-world registry data have the enormous potential to identify the value of spine care at the population level and at the individual patient level. Accurately identifying contributors of high- and low-value spine care and incentivizing providers accordingly have the potential to yield tremendous economic and health benefit at the population level. The keys to identifying and optimizing the value of any treatment or disease management strategy ultimately lies at the individualized patient level, where heterogeneous patients demonstrate large variation in treatment response and cost. Understanding variation in individual-level treatment response allows a decision maker to apply an effective treatment to the ideal patient to optimize value. In this analysis, utilizing a single-center prospective longitudinal registry data, we demonstrate the variability in outcomes and cost at population level and individual patient level for patients undergoing spine surgery for degenerative diseases. METHODS Retrospective analysis of prospective longitudinal spine registry based data was conducted. The inclusion criteria of the registry were: (1) patient’s age > 18 years; (2) presenting with leg and/or back pain; (3) correlative imaging findings for the degenerative lumbar spine diagnosis including disk herniation, stenosis, spondylolisthesis, adjacent segment disease, and recurrent disk herniation; and (4) failed multimodal nonoperative care (including bracing, pharmacological therapies, or injection therapy) over 3 months or patients with progressive neurological deficit. The exclusion criteria were: (1) diagnosis of spinal tumor, trauma, or infection; (2) any extraspinal cause of back or leg pain; (3) patients who were unwilling or unable to participate in the follow-up questionnaires. Patient demographics including age at the time of surgery, body mass index, duration of preoperative narcotic use (days), smoking status of the patient, symptom duration, history of prior surgery, employment status, comorbidities including diabetes, hypertension, coronary artery disease, myocardial infarction, preoperative anticoagulation, congestive heart failure, chronic obstructive pulmonary disease, and osteoporosis, clinical presentation, operative variables, including intraoperative estimated S62 | VOLUME 80 | NUMBER 3 | MARCH 2017 Supplement blood loss, length of surgery, length of hospital stay, and postoperative morbidity including 90-day complications, and discharge destination (home vs facility) are reviewed through electronic medical records. Patient-reported Outcomes Validated PROs were recorded at baseline and 12 months after surgery: (1) back-related disability: Oswestry Disability Index (ODI)22 ; (2) numeric rating scale pain scores for back pain and leg pain23 ; (3) quality of life: EuroQol-5D (EQ-5D)24 . For this analysis, the concept of minimum clinically important difference (MCID) was used to define the clinically significant improvement in disability (ODI). The MCID is a critical threshold that compares the change in score for a PRO following the intervention to another externally validated measure of outcomes such as perceived improvement or satisfaction following the procedure in question.25,26 Previously published MCID values for the ODI (14.9) were used for analysis.27 Cost Data Incremental cost including both direct health care expenditures and indirect economic consequences from societal perspective are captured. Total costs were defined as sum of direct and indirect cost. The direct cost included costs associated with inpatient hospital stay (hospital cost), surgeons’ professional fee, readmission cost, and postdischarge health care resource utilization including, based on the patient self-reported frequency of health care provider visits, medication use and diagnostic imaging utilization. Indirect costs included patient or family member workday losses and cost of a caregiver, if this was needed.28-32 Quality-adjusted Life Years Calculation Quality-adjusted life years (QALYs) were calculated from the EQ-5D with US valuation using time-weighted area under the curve approach.33 Mean total 1-year cost per QALY-gained after surgery was assessed. For patients with 2-year follow-up, mean total 2-year cost per QALY-gained after surgery was assessed. RESULTS Patient Demographics A total of 1454 patients undergoing elective lumbar surgery for disk herniation, revision disk herniation, stenosis, spondylolisthesis, and adjacent segment disease were analyzed. Mean age ± standard deviation of the cohort was 58.9 ± 13.7 years with 718 (49.3%) males. Table 1 summarizes the characteristics of the patients enrolled in the registry for lumbar spine diagnosis. Principal diagnoses in descending order of frequency were lumbar stenosis (38.3%), lumbar spondylolisthesis (25.1%), lumbar disk herniation (20.5%), adjacent segment disease 146 (10%), and recurrent disk herniation (6%). Fifty-three percent of patients (n = 767) underwent lumbar fusion surgery. Outcomes There was significant improvement in disability (ODI), pain (back and leg), and quality of life scores (EQ-5D) at 1 year after surgery (P < .0001). Figure 1 illustrates the group mean of a cohort’s PROs, improvements in pain, disability, and quality of life. However, at the individual patient level, tremendous www.neurosurgery-online.com ESTABLISHING VALUE IN SPINE SURGERY TABLE 1. Patient Demographic and Diagnosis Characteristics Total n = 1454 n (%) Age (at time of surgery; mean ± SD) BMI (mean ± SD) Smoker Gender: male Zung depression scale score (mean ± SD) MSPQ anxiety score (mean ± SD) ASA grades (>3) History of diabetes History of myocardial infarction History of hypertension Duration of symptoms > 12 months Neurogenic claudication Motor deficit Revision surgery Diagnosis Stenosis Spondylolisthesis disk herniation Adjacent segment disease Recurrent disc herniation Fusion Number of levels involved (mean ± SD) Length of surgery in minutes (mean ± SD) Length of hospital stay in days (mean ± SD) 58.9 ± 13.7 years 30.9 ± 7.1 236 (16.2%) 718 (49.3%) 34.8 ± 9.2 5.9 ± 4.5 938 (64.4%) 334 (22.9%) 77 (5.3%) 875 (60.1%) 799 (54.9%) 288 (19.7%) 449 (30.8%) 408 (28.1%) 557 (38.3%) 366 (25.2%) 298 (20.5%) 146 (10%) 87 (6%) 767 (52.7%) 1.8 ± 0.8 187.7 ± 93.3 3.2 ± 4.5 variability in outcome was observed despite having the same diagnosis and undergoing the same surgical treatment. For surgeries demonstrating health benefit and value via traditional metrics (group average change), 12.5% (n = 182) of patients experienced no gain from surgery and 38% (n = 554) failed to achieve clinically meaningful benefit by MCID threshold (Figure 2). This was true for each of 5 common surgical diagnoses. Surgery was of little to no value for these subsets of patients. The quality outcome database (QOD) registry is national multicenter prospective longitudinal registry, designed to establish risk-adjusted expected morbidity rates and outcomes for the most common surgical procedures performed by spine surgeons.34,35 The QOD registry enrolls spine surgery patients from 76 participating centers across 28 US states via representative sampling and collects measures of surgical safety and PROs.36 Pain, disability, quality of life, and return to work are measured using valid instruments. A tremendous variability in PROs outcome was observed despite having the same diagnosis and undergoing the same surgical treatment, at the individual patient level (Figure 3). These variations observed at 76 centers from different geographical location validate the variability observed at the single-center Vanderbilt Spine Registry. Cost The mean direct cost at 1 year was $25 459 ± $9896, and the mean total cost was $28 340 ± $12 204. Table 2 summarizes the cost breakdown for all the patients. The mean 1-year QALYgained was 0.29 for all diagnosis, and 18% of patients failed to NEUROSURGERY report gain in QALY at 1 year postoperatively. For the patients followed up to 2 year postoperatively, the mean total 2-year cost was $31 834 ± $15 220 (direct cost: $28 953 ± $12 781) and the mean 2-year QALY-gained was 0.62 for all diagnosis, and 14% of patients failed to report gain in QALY at 2 year postoperatively. Figure 4 demonstrates that a significant variation was observed in both benefit (QALY-gained on X axis) and 2-year cost of care (Y axis). While on average, surgery resulted in a 2-year gain of 0.62 QALYs at an average direct cost of $28 953, resulting in cost per QALY-gained of $51 762. As demonstrated in Figure 4, the patients fell in all 4 quadrants of value: QALY gain with low cost (greatest value), QALY gain with high cost, QALY loss with low cost, and QALY loss with high cost (lowest value). For the patients undergoing laminectomy and fusion surgery for the diagnosis of spondylolisthesis, the mean total direct cost at 2 year was $59 700/QALY, but varied from $10 728/QALY to $302 937/QALY at the individual patient level. Such variations were observed for all diagnoses. DISCUSSION Value in spine care is a measure of the outcome of all health care services delivered to maximize a person’s function and participation in society while minimizing impairments, pain, and other symptoms.16,37 High-value care is not merely a broad application of a treatment found to be cost-effective in a research study, but rather personalized application of the best available treatment for a given patient at the correct time, with the best adjuvant care throughout the health care episode. Low-value care can be realized 1 of 2 ways: (1) failing to experience any health benefit or loss of health status (decreasing the numerator of the value equation), or (2) experiencing minimal to modest health gains that require expenditures well outside the group average (increasing the denominator of the value equation).15 Therefore, the value of intervention needs to be evaluated at the population level and at the individual patient level. In our study, at population level, there was a significant improvement in disability outcome and quality of life 1 year after lumbar spine surgery. However, there was wide variability in effectiveness, representing a lack of treatment optimization as well as lack of generalizability of spinal surgical procedures. At individual patient level, about oneeighth of the patients did not experience any gain from surgery and about one-third did not achieve meaningful improvement. The in-depth assessment of what identifiable factors are common for these patients is vital to refine current treatment indications and decision-making. The patients that are less likely to gain improvement from spine surgery might gain benefit from other treatment strategies, or intervention focusing on some of the individual modifiable factors might increase the likelihood of gaining benefit from surgery. This is the essence of individualized or personalized health care. Value from the patient’s perspective is heavily dependent on desirable and accurately measured patient-centered outcomes VOLUME 80 | NUMBER 3 | MARCH 2017 Supplement | S63 PARKER ET AL FIGURE 1. Mean ODI and EQ-5D (quality of life) at baseline, 3 months, and 12 months after surgery for patients undergoing surgery for the diagnosis of disk herniation, recurrent disk herniation, spondylolisthesis, stenosis, and adjacent segment disease. On average, surgery resulted in a significant improvement in ODI and EQ-5D at 1 year following surgery. against the risk and cost of care over the patient’s entire life span. Traditional health economic studies report and draw conclusions based on the aggregate average incremental cost of care and average incremental benefit of care at the group-mean level. In reality, singular treatments for standardized diagnosis types still result in a wide variation of observed costs. Tosteson S64 | VOLUME 80 | NUMBER 3 | MARCH 2017 Supplement et al31 reported a direct cost of $21 756 for lumbar fusion for spinal stenosis at 2 years postoperatively. For the same procedure, same indication, and same follow-up, Tso et al38 reported a direct cost of $13 892. The main differences in the studies were that the former study31 used Medicare national reimbursement adjustment for cost and included 2 year follow-up costs, whereas www.neurosurgery-online.com ESTABLISHING VALUE IN SPINE SURGERY FIGURE 2. Scattergram of patient-level response. Each dot represents a single patient. Dots above the diagonal line reported worsened ODI 1 year after surgery, while those below the dotted line reported improved ODI. The farther the distance from the diagonal line, the greater the change in disability. Blue dots represent patients who did not achieve an MCID improvement 1 year after surgery and green dots represent patients who achieved MCID at 1 year after surgery. NEUROSURGERY VOLUME 80 | NUMBER 3 | MARCH 2017 Supplement | S65 PARKER ET AL FIGURE 3. Variation in improvement in quality of life (EQ-5D) for the 5 common lumbar diagnoses. Distance from the diagonal line represents patient-level response. Each dot represents a single patient. Dots above the diagonal line represent improved health state 1 year after surgery, while those below the dotted line reported declined health state. While surgery for each diagnosis yielded between a 0.2 and 0.29 QALY gain on average by 1 year after surgery, 18% of patients failed to report a QALY gain. The wide variation in reported QALY-gained across the 76-center QOD network is consistent with the variation observed at the Vanderbilt Spine Registry reported above. S66 | VOLUME 80 | NUMBER 3 | MARCH 2017 Supplement www.neurosurgery-online.com ESTABLISHING VALUE IN SPINE SURGERY TABLE 2. Mean 1-year Costs Hospital cost $19 582 ± $8089 Surgeons’ professional fee Postdischarge HCRU 1 year Indirect cost 1 yeara Direct cost 1 year Total cost 1 year $2824 $3067 $2880 $25 459 $28 340 ± ± ± ± ± $1188 $590 $6713 $9896 $12 204 a The indirect cost was as high as $9299 for patients who were employed preoperatively and/or whose either a family member took a day off, and/or a caregiver was hired to care for the patient. HCRU, healthcare resource utilization. Tso et al38 utilized a case-costing database and did not include the follow-up costs. Cost represents not only the expenditures for the surgery, but expenditures associated with complications, all-cause perioperative readmissions, or any disease-related care utilization within the episode of care. Costs from hospital perspective include direct costs, costs of staff, supplies, and utilities. Costs from payers’ and providers’ perspective include payment to hospital and physicians. From the societal perspective, cost includes lost work productivity, loss of contribution to society, as well as all downstream-associated costs for caregivers and indirect consequences of care.39-45 An acceptable “bang-for-buck” or QALYgained from surgery is relative to the perspective of the payer, purchaser, or society. An intervention is considered cost-effective if the cost per QALY-gained is within the predetermined society’s willingness to pay threshold.28,46-49 Various willingness to pay thresholds are reported in the literature, each of which is derived based on different context (improving QALYs vs life saving or life extending) and perspectives (individual vs societal).50,51,52 What is thought to be cost-effective is in the eyes of the payer, and currently assigned thresholds may vary depending upon the socioeconomic status of the patient.49,53-55 Therefore, there is FIGURE 4. Scatterplot of 2-year direct health care cost per QALY-gained after single-level surgery for lumbar spine diagnoses in an uncontrolled real-world setting. Each dot represents a single patient. Tremendous variation was observed in both benefit (QALY-gained on X axis) and 2-year cost of care (Y axis). While on average, surgery resulted in a 2-year gain of 0.615 QALYs at an average cost of $28 953, patients fell in all 4 quadrants of value: QALY gain with low cost (greatest value), QALY gain with high cost, QALY loss with low cost, and QALY loss with high cost (lowest value). Diagonal line represents $50 000 cost per QALY-gained. NEUROSURGERY VOLUME 80 | NUMBER 3 | MARCH 2017 Supplement | S67 PARKER ET AL no single generally accepted threshold that can be used as a cut-off for deciding if an intervention is cost-effective. The commonly used willingness to pay threshold is $20 000 to $30 000 in the UK56,57 and $50 000 to $100 000 in the US58,59 , whereas WHO has recommended that any intervention that is 1 to 3 times the country’s GDP is considered cost-effective.50,60 Numerous studies have analyzed the cost-effectiveness of various spine procedures.47,61,62 The mean 1-year cost per QALY-gained, in our analysis, was $97 388/QALY-gained. For patients with 2year follow-up, the mean 2-year cost per QALY-gained was $51 762/QALY-gained. Distinguishing individual patient level cost per benefit from a verage group-level cost per benefit allows a much more granular way to optimize the value of treatments and care paradigms through refinement of procedure indications and delivery. As demonstrated in this analysis, there was a considerable variation in the cost per benefit at the individual patient level. At population level, a treatment may be considered high value when evaluated as the mean of the group. In the subsets of patients failing to benefit or experiencing morbid or costly complications, however, a given treatment loses its value. As we understand the variability in the cost and benefit at the individual patient level, we can now focus on identifying the modifiable factors associated with outliers of high- and low-value spine care. Designing interventions to manipulate those factors should help contain costs and improve surgical outcomes, thereby increasing the overall value of spine care. Prospective registries have proven potential to assess the safety, quality, and value of spine care at both individual patient level and at the population level.36,63-65 The registries provide reliable and expeditious access to outcomes data such as complications, readmission, pain, disability, quality of life, patient satisfaction, and cost-effectiveness.63 Moving forward, individual providers and hospital systems can utilize the real-world registry outcomes and cost data to perform an in-depth assessment of individual patient level factors that can be modified to increase the benefit and lower the cost of spine care. Furthermore, this will allow the clinicians to better target interventions to improve outcomes in nonresponders. As the value equation takes on further dimensions, the decision makers can prevent ineffective or wasteful care at the population level as well as individual patient level, to increase the overall value of spine care. CONCLUSION Value in spine care is a measure of the outcome of all health care services delivered to maximize a person’s function and participation in society while minimizing impairments, pain, and other symptoms. High-value care is not merely broad application of a treatment found to be cost-effective on average in a research setting, but rather personalized application of the best available treatment for a given patient at the correct time, with the best adjuvant care throughout the health care episode. Spine treatments that, on average, are cost-effective may have wide variability S68 | VOLUME 80 | NUMBER 3 | MARCH 2017 Supplement in value at the individual patient level. The wide variability in effectiveness and cost of care at the individual patient level demonstrated here represents an opportunity through registries to identify specific care that may be less effective, and refine patientspecific care delivery and indications to drive overall grouplevel treatment value. Understanding value of spine care at an individualized as well as population level will allow clinicians, and eventually payers, to better target resources for improving care for nonresponders, ultimately driving up the average health for the whole population. Disclosure The authors have no personal, financial, or institutional interest in any of the drugs, materials, or devices described in this article. REFERENCES 1. Kronick R, Rousseau D. Is Medicaid sustainable? Spending projections for the program’s second forty years. Health Aff. 2007;26(2):w271-w287. 2. Poisal JA, Truffer C, Smith S, et al. Health spending projections through 2016: modest changes obscure part D’s impact. Health Aff. 2007;26(2):w242-w253. 3. Chernew ME, Hirth RA, Cutler DM. Increased spending on health care: how much can the United States afford? Health Aff. 2003;22(4):15-25. 4. Centers for Medicare and Medicaid Services. NHE Fact Sheet. 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