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The mission of Food and Drug Administration (FDA)'s Center for Devices and Radiological Health is to protect and promote public health. It assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products by providing meaningful and timely information about the products we regulate and the decisions we make. On September 17, 2021, an FDA workshop was held to provide information to stakeholders, including members of the spine community, device manufacturers, regulatory affairs professionals, clinicians, patients, and the general public regarding FDA regulations, guidance and regulatory pathways related to spinal device clinical review. It was not intended to communicate any new policies, processes, or interpretations regarding medical device marketing authorizations. This workshop consisted of individual presentations, group discussions, question and answer sessions, and audience surveys. Information-sharing included discussions related to patient-reported outcomes, clinician-reported outcomes, observer-reported outcomes, and performance outcomes. Discussions involving external subject matter experts covered topics related to spinal device clinical studies including definition of a target population, enrollment criteria, strategies for inclusion of under-represented patient groups, reporting of adverse event and secondary surgical procedures, clinical study endpoints, and clinical outcome assessments. A meeting transcript and webcast workshop link are currently posted on the FDA website. Important related issues and challenges were discussed, and an exciting range of new ideas and concepts were shared which hold promise to advance regulatory science, patient care and future innovation related to spinal devices. [ABSTRACT FROM AUTHOR]

Background Context: Improving value is an established point of emphasis to reduce the rapidly rising health care costs in the United States. Back pain is a major driver of costs with a substantial fraction caused by lumbar radiculopathy. The most common surgical treatment for lumbar radiculopathy is microdiscectomy. Research is sparse regarding variables driving cost in microdiscectomies and often limited by cost data derived from payer-based Medicare data.Purpose: To identify targets for cost reduction by determining variables associated with significant cost variation in microdiscectomies, using cost data derived from the Value Driven Outcomes tool and actual system costs.Study Design: Single-center, retrospective study of prospectively collected registry data.Patient Sample: Six hundred twenty-two patients identified by CPT code and manually screened for initial, unilateral, single-level lumbar discectomy performed between 2014 and 2018 at a single institution.Outcome Measures: Primary outcome measures include total direct cost, clinical length of stay, and OR minutes. Total Direct Cost was further differentiated into facility and nonfacility costs.Methods: Univariate and multivariate generalized linear models (GLM) were used to identify variables associated with variation in primary outcome measures. Costs were normalized by mean cost for patients with normal body mass index (BMI) and a healthy American Society of Anesthesiologists (ASA) classification. Average marginal effects were reported as percentage of normalized costs.Results: Advanced age, male gender, Hispanic, black, unemployment, obesity, higher ASA class, insurance status, and being retired were positively associated with costs in univariate analysis. Asian, Native American, outpatient procedures, and being a student were associated with decreases in costs. In multivariate analysis, we found that obesity led to higher average marginal total direct (9%), total facility (15%), and facility OR costs (22%), as well as 24 more OR minutes per surgery. While being overweight was not associated with greater total direct costs, it was associated with higher total facility (8%), and facility OR costs (12%), with 11 more OR minutes per surgery. Age was associated with a longer LOS but not with OR costs. As expected, outpatient surgical costs, LOS, and OR time were significantly lower than inpatient procedures. Severe systematic disease was associated with greater total and nonfacility costs. In addition, Medicare patients had higher facility costs (14%) compared to privately insured patients.Conclusions: Significant drivers of total direct cost in multivariate GLM analysis were obesity, severe systemic disease and inpatient surgery. Average LOS was increased due to age and inpatient status, conversely it was decreased by unemployment and retirement. Significant variables in OR time were male sex, Hispanic race and both obese and overweight BMIs. [ABSTRACT FROM AUTHOR]

Study Design: Analysis of National Inpatient Sample (NIS), 2004 to 2015.Objective: Describe recent trends in US rates of lumbar fusion procedures and associated costs, by surgical indication.Summary Of Background Data: Spinal fusion is appropriate for spinal deformity and instability, but evidence of effectiveness is limited for primary disc herniation and spinal stenosis without instability. It remains controversial for treatment of axial pain secondary to degenerative disc disease. There are potential non-instability, non-deformity indications for fusion surgery, including but not limited to severe foraminal stenosis and third-time disc herniation.Methods: Elective lumber fusion trends were reported using Poisson regression, grouped by indication as degenerative scoliosis, degenerative spondylolisthesis, spinal stenosis, disc herniation, and disc degeneration. Generalize linear regression was used to estimate trends in hospital costs, adjusted for age, sex, indication, comorbidity, and inflation.Results: Volume of elective lumbar fusion increased 62.3% (or 32.1% per 100,000 US adults), from 122,679 cases (60.4 per 100,000) in 2004 to 199,140 (79.8 per 100,000) in 2015. Increases were greatest among age 65 or older, increasing 138.7% by volume (73.2% by rate), from 98.3 per 100,000 (95% confidence interval [CI] 97.2, 99.3) in 2004 to 170.3 (95% CI 169.2, 171.5) in 2015. Although the largest increases were for spondylolisthesis (+47,390 operations, 111%) and scoliosis (+16,129 operations, 186.6%), disc degeneration, herniation, and stenosis combined to accounted for 42.3% of total elective lumbar fusions in 2015. Aggregate hospital costs increased 177% during these 12 years, exceeding $10 billion in 2015, and averaging more than $50,000 per admission.Conclusion: While the prevalence of spinal pathologies is not known, the rate of elective lumbar fusion surgery in the United States increased most for spondylolisthesis and scoliosis, indications with relatively good evidence of effectiveness. The proportion of fusions coded for indications with less evidence of effectiveness has slightly decreased in the most recent years.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]

Background Prescription opioid medications negatively affect postoperative outcomes after lumbar spine surgery. Furthermore, opioid-related overdose death rates in the United States increased by 200% between 2000 and 2014. Thus, alternatives are imperative. Mindfulness-based stress reduction (MBSR), a mind-body therapy, has been associated with improved activity and mood in opioid-using patients with chronic pain. This study assessed whether preoperative MBSR is an effective adjunct to standard postoperative care in adult patients undergoing lumbar spine surgery for degenerative disease. Methods The intervention group underwent a preoperative online MBSR course. The comparison group was matched retrospectively in a 1:1 ratio by age, sex, type of surgery, and preoperative opioid use. Prescription opioid use during hospital admission and at 30 days postoperatively were compared with preoperative use. Thirty-day postoperative patient-reported outcomes for pain, disability, and quality of life were compared with preoperative patient-reported outcomes. Dose-response effect of mindfulness courses was assessed using Mindful Attention Awareness Scale scores. Results In this pilot study, 24 participants were included in each group. Most intervention patients (70.83%) completed 1 session, and the mean Mindful Attention Awareness Scale score was 4.28 ± 0.71 during hospital admission. At 30 days, mean visual analog scale back pain score was lower in the intervention group (P = 0.004) but other patient-reported outcomes did not differ. Conclusions During hospital admission, no significant dose-response effect of mindfulness techniques was found. At 30 days postoperatively, MBSR use was associated with less back pain. Further research is needed to assess the effectiveness of preoperative MBSR on postoperative outcomes in lumbar spine surgery for degenerative disease. Highlights • During admission, there was no dose-response effect of mindfulness on opioid intake. • At 30 days, MBSR participants had lower mean VAS-BP scores. • There was no difference in morphine-equivalent dosing at 30-day follow-up. [ABSTRACT FROM AUTHOR]

Abstract: Background context: The veteran population presents a unique confluence of biopsychosocial factors in the treatment of spinal conditions. In addition to poorer health status and higher numbers of chronic medical conditions compared with the general population, previous reports have highlighted the high prevalence of psychological disorders within the Department of Veterans Affairs (VA) health system. To our knowledge, no study has specifically evaluated psychological distress in patients with a spinal disorder within the VA health system. Purpose: To determine the prevalence of psychological distress among spine patients in a VA hospital and if higher levels of distress correlated with patient demographics and self-reported patient outcome scores. Study design/setting: Cross-sectional evaluation of adult patients at a regional VA outpatient orthopedic spine surgery clinic. Patient sample: One hundred forty-nine adult patients presenting for treatment of spine-related disorders. Outcome measures: Patients were evaluated using the Distress and Risk Assessment Method (DRAM), a validated survey consisting of the Zung Depression Scale and the Modified Somatic Perception Questionnaire. In addition, self-reported pain, disability, and quality of life were assessed using the visual analog scale (VAS) for neck or back pain and the Neck Disability Index or Oswestry Disability Index (ODI) depending on the patient''s location of pain. Methods: The DRAM survey was used to determine the prevalence of psychological distress by classifying patients into normal, at-risk, and severe distress groups. Visual analog scale scores for neck and back pain, and self-reported disability scores, and demographic data including age, gender, combat experience, and use of antidepressant, anxiolytic, or narcotic medications were obtained at the time of enrollment. Results: The DRAM survey identified 79.9% of patients as having some degree of psychological distress, whereas the remaining 20.1% were classified as normal. Among those with psychological distress, 43.6% of patients were categorized as severe distress. Compared with the normal group, a history of combat was more frequent in all distressed patient groups including the at-risk (p=.04) and severe distress (p=.009) groups. Those in the severe distress category more commonly reported the use of narcotics (p=.043) and antidepressant/anxiolytics medications (p=.0001). Those in the severe distress group had significantly higher ODI scores (p<.0001) and back pain VAS scores (p=.0360) compared with the normal group. Conclusions: We identified a large number of patients (80%) with some level of psychological distress and 43% with severe distress. The percent of patients with severe psychological distress in the VA was double that previously reported in a non-VA patient setting. Patients with severe distress had higher ODI scores, back pain VAS scores, use of narcotics and antidepressants, and a reported history of combat when compared with those without distress. [Copyright &y& Elsevier]

BACKGROUND CONTEXT Lumbar fusion surgery for degenerative disease has been subject to increased scrutiny by payers. The procedure is not indicated for primary disc herniation or spinal stenosis without segmental instability, and is controversial for chronic back pain attributed to degenerative disc disease. Evidence has supported fusion for spondylolisthesis, but this indication has been called into question by two randomized trials. PURPOSE We sought to examine the impact of developing clinical evidence on US population rates of lumbar fusion, and associated costs, by surgical indication. STUDY DESIGN/SETTING Retrospective analysis of the Agency for Healthcare Research and Quality's National Inpatient Sample from 2004 to 2013, a nationally representative discharge registry. PATIENT SAMPLE We identified adults (age 20+) undergoing lumbar fusion operations for elective degenerative spinal diagnoses in the US OUTCOME MEASURES US population-based rates of hospital discharges for lumbar fusion, by indication, and associated hospital costs. METHODS Surgical indications were grouped as degenerative scoliosis, degenerative spondylolisthesis, spinal stenosis without deformity, disc herniation and disc degeneration. Age- and sex-adjusted rates of lumbar fusion operation per 100,000 US adult residents, by indication, were reported using Poisson regression. Generalized linear regression was used to estimate trends in hospital costs, adjusted for age, sex, indication, comorbidity and inflation. RESULTS The total number of elective lumbar fusion operations for degenerative diagnoses increased 51.3% (or a 28.4% increase in rate per 100,000 US adults), from 127,453 cases (62.3 per 100,000) in 2004 to 192,860 (80.0 per 100,000) in 2013. Increases were greatest among those age 65 or older, increasing 67.3%, from 100.0 per 100,000 (95% CI: 98.9-101.0) in 2004 to 167.3 (95% CI: 166.1-168.4) in 2013. Although the largest increases were for spondylolisthesis and scoliosis, disc degeneration, herniation and stenosis combined to account for 44.8% of total elective lumbar fusions in 2013. Hospital costs more than doubled during the 10-year study, exceeding $9 billion in 2013, averaging nearly $50,000 per admission. CONCLUSIONS Although the rate of fusion for disc herniation, disc degeneration, or spinal stenosis decreased in recent years, nearly half of all elective lumbar fusions in the US were performed for these indications. The rate of elective lumbar fusion surgery in the United States increased most for spondylolisthesis and scoliosis, indications with relatively well-supported evidence of effectiveness. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Objective: Clear diagnostic delineation is necessary for the development of a strong evidence base in lumbar spinal surgery. Experience with existing national databases suggests that International Classification of Diseases, Tenth Edition (ICD-10) coding is insufficient to support that need. The purpose of this study was to assess agreement between surgeon-specified diagnostic indication and hospital-reported ICD-10 codes for lumbar spine surgery., Methods: Data collection for the American Spine Registry (ASR) includes an option to denote the surgeon's specific diagnostic indication for each procedure. For cases treated between January 2020 and March 2022, surgeon-delineated diagnosis was compared with the ICD-10 diagnosis generated by standard ASR electronic medical record data extraction. For decompression-only cases, the primary analysis focused on the etiology of neural compression as determined by the surgeon versus that determined on the basis of the related ICD-10 codes extracted from the ASR database. For lumbar fusion cases, the primary analysis compared structural pathology, which may have required fusion, as determined by the surgeon versus that determined on the basis of the extracted ICD-10 codes. This allowed for identification of agreement between surgeon delineation and extracted ICD-10 codes., Results: In 5926 decompression-only cases, agreement between the surgeon and ASR ICD-10 codes was 89% for spinal stenosis and 78% for lumbar disc herniation and/or radiculopathy. Both the surgeon and database indicated no structural pathology (i.e., none) suggesting the need for fusion in 88% of cases. In 5663 lumbar fusion cases, agreement was 76% for spondylolisthesis but poor for other diagnostic indications., Conclusions: Agreement between surgeon-specified diagnostic indication and hospital-reported ICD-10 codes was best for patients who underwent decompression only. In the fusion cases, agreement with ICD-10 codes was best in the spondylolisthesis group (76%). In cases other than spondylolisthesis, agreement was poor due to multiple diagnoses or lack of an ICD-10 code that reflected the pathology. This study suggested that standard ICD-10 codes may be inadequate to clearly define the indications for decompression or fusion in patients with lumbar degenerative disease.

Background: Spine surgery and its corresponding costs have increased in recent years and are variable across geographic regions. Discretionary care is the component of spending variation that is independent of illness severity, age, and regional pricing. It is unknown whether greater discretionary care is associated with improved safety for patients undergoing spine surgery, as we would expect from value-based health care., Methods: We conducted an analysis of 5 spine surgery cohorts based on Medicare claims from 2013 to 2017. Patients were grouped into quintiles based on the Dartmouth Atlas End-of-Life Inpatient Care Index (EOL), reflecting regional spending variation attributed to discretionary care. Multivariable regression examined the association between discretionary care and safety measures while controlling for age, sex, race, comorbidity, and hospital features., Results: We observed a threefold to fourfold variation in 90-day episode-of-care cost across regions, depending on the cohort. Spine-specific spending was correlated with EOL quintile, confirming that spending variation is due more to discretionary care than it is to pricing, age, or illness severity. Greater spending across EOL quintiles was not associated with improved safety, and, in fact, was associated with poorer safety in some cohorts. For example, all-cause readmission was greater in the high-spending EOL quintile relative to the low-spending EOL quintile among the "fusion, except cervical" cohort (14.2% vs. 13.1%; OR = 1.10; 95% CI = 1.05 to 1.20), the "complex fusion" cohort (28.0% vs. 25.4%; OR = 1.15; 95% CI = 1.01 to 1.30), and the "cervical fusion" cohort (15.0% vs. 13.6%; OR = 1.12; 95% CI = 1.05 to 1.20)., Conclusions: Wide variation in spending was not explained by differences in illness severity, age, or pricing, and increased discretionary care did not enhance safety. These findings point to inefficient use of health-care resources, a potential focus of reform., Level of Evidence: Economic and Decision Analysis Level IV. See Instructions for Authors for a complete description of levels of evidence., Competing Interests: Disclosure: The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJS/G821)., (Copyright © 2021 by The Journal of Bone and Joint Surgery, Incorporated.)

Background: In anticipation of a demand surge for hospital beds attributed to the coronavirus pandemic (COVID-19) many US states have mandated that hospitals postpone elective admissions., Objectives: To estimate excess demand for hospital beds due to COVID-19, the net financial impact of eliminating elective admissions in order to meet demand, and to explore the scenario when demand remains below capacity., Research Design: An economic simulation to estimate the net financial impact of halting elective admissions, combining epidemiological reports, the US Census, American Hospital Association Annual Survey, and the National Inpatient Sample. Deterministic sensitivity analyses explored the results while varying assumptions for demand and capacity., Subjects: Inputs regarding disease prevalence and inpatient utilization were representative of the US population. Our base case relied on a hospital admission rate reported by the Center for Disease Control and Prevention of 137.6 per 100,000, with the highest rates in people aged 65 years and older (378.8 per 100,000) and 50-64 years (207.4 per 100,000). On average, elective admissions accounted for 20% of total hospital admissions, and the average rate of unoccupied beds across hospitals was 30%., Measures: Net financial impact of halting elective admissions., Results: On average, hospitals COVID-19 demand for hospital bed-days fell well short of hospital capacity, resulting in a substantial financial loss. The net financial impact of a 90-day COVID surge on a hospital was only favorable under a narrow circumstance when capacity was filled by a high proportion of COVID-19 cases among hospitals with low rates of elective admissions., Conclusions: Hospitals that restricted elective care took on a substantial financial risk, potentially threatening viability. A sustainable public policy should therefore consider support to hospitals that responsibly served their communities through the crisis., Competing Interests: Coauthors B.I.M. and R.E.N. receive partial salary support from an AHRQ-Funded R01 (Grant #R01HS024714) paid directly to the institution. The remaining authors declare no conflict of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Study Design: Retrospective review., Objective: To define the geographic variation in costs of anterior cervical discectomy and fusion (ACDF) and posterolateral fusion (PLF)., Summary of Background Data: ACDF and lumbar PLF are common procedures that are used in the treatment of spinal pathologies. To optimize value, both the benefits and costs of an intervention must be quantified. Data on costs are scarce in comparison with data on total charges. This study aims at defining the costs of ACDF and PLF and describing the geographic variation within the United States., Methods: Medicare Provider Utilization and Payment data were used to investigate the costs associated with ACDF, PLF, and total knee arthroplasty (TKA). Average total costs of the procedures were compared by state and geographic region., Results: Combined professional and facility costs for a single-level ACDF had a national mean of $13,899. Total costs for a single-level PLF had a mean of $25,858. Total costs for a primary TKA had a national mean of $13,039. The cost increased to an average of $22,138 for TKA with major comorbidities. Analysis of geographic trends showed statistically significant differences in total costs of PLF, TKA, and TKA, with major complications or comorbidities between geographic regions (P < 0.01 for all)., Conclusion: Three of the 4 procedures (PLF, TKA, and TKA with major complications or comorbidities) showed statistically significant variation in cost between geographic regions. The Midwest provided the lowest cost for all procedures. Similar geographic trends in the cost of spinal fusions and TKAs suggest that these trends may not be limited to spine-related procedures. Surgical costs were found to correlate with cost of living but were not associated with the population of the state. These data shed light on the actual cost of common surgical procedures throughout the United States and will allow further progress toward the development of cost-effective, value-driven care., Level of Evidence: 3.

Over the last decade a number of new technologies have been introduced to the area of spine care. Although this recent explosion of innovation has brought advances to patient care, it has also brought concerns regarding overuse, increasing costs, and safety. A value-based approach to assessing and purchasing new technology depends on a shift toward comparative effectiveness analysis, transparency in pricing and potential conflicts of interest, and an alignment of incentives and goals among purchasers, consumers, and payers. How to assess the effectiveness of new technology in patient care is an unresolved issue for any cost-effectiveness analysis, as models traditionally used to assess medical therapies (ie, quality-adjusted life years) may not be directly applicable to analysis of surgical intervention. Spine surgeons must be involved in multidisciplinary collaborative efforts to develop models of efficacy analysis and to direct outcomes-based research to appropriately evaluate the benefits of surgical interventions and new technologies.

Study Design: A retrospective cohort study of operative versus nonoperative treatment of isolated type II odontoid fractures in patients aged 80 years and more without neurologic deficit admitted to a level 1 spinal cord injury center between June 1985 and July 2006., Objective: To assess the presentation and acute complications of operatively and nonoperatively managed type II odontoid fractures in the octogenarian population., Summary of Background Data: Type II odontoid fractures are the most common cervical spine fracture in the elderly. Studies suggest acute in-hospital complication rates in type II odontoid fractures in the elderly exceed 50%. Few studies have examined the acute in-hospital outcomes of isolated type II odontoid fractures in the octogenarian population., Methods: The medical records of 223 consecutive C2 fractures from June 1985 to July 2006 over the age of 80 years were reviewed retrospectively. Patients with associated cervical spine fractures were excluded. Eighty neurologically intact patients over age 80 were identified with isolated acute type II odontoid fractures. The charts were reviewed and mechanism of injury, comorbidities, date of injury, date of admission, date of discharge, radiology reports, discharge disposition, associated injuries, fracture management, type of surgical fixation (if any), and documented complications were abstracted., Results: Thirty-two patients received operative treatment (10 anterior and 22 posterior) and 40 patients received nonsurgical treatment. Eight patients were excluded because the medical record could not be located. The mean age was 85.5+/-3.5 years in the surgical and 87.3+/-4.7 years in the nonsurgical group (P>0.05); mean length of acute hospital stay was 11.2+/-8.5 days in the nonsurgical and 22.8+/-28.3 days in the surgical group (P<0.05); mean comorbidity score was 2.3+/-1.2 in the nonsurgical and 2.0+/-1.0 in the surgical group (P>0.5); mean fracture displacement was 4.1+/-3.5 mm in the nonsurgical and 3.9+/-3.4 mm in the surgical group (P>0.5). Acute in-hospital mortality rate was 15% in the nonsurgical group and 12.5% in the surgical group (P>0.05). The percentage of patients experiencing at least one significant complication was higher in the operative group than the nonoperative group (62% vs. 35%, respectively, P<0.05)., Conclusions: Type II odontoid fractures in the octogenarian population are associated with substantial morbidity and mortality, irrespective of management method. Prospective studies are needed to better elucidate management strategies for this difficult clinical problem.

Study Design: Questionnaires administered to practicing orthopedic and neurosurgical spine surgeons from various regions of the United States and abroad., Objectives: To determine similarities and differences in the treatment of spinal trauma., Summary of Background Data: Spinal trauma is generally referred to subspecialists of orthopedic or neurosurgical training. Prior studies have suggested that there is significant variability in the management of such injuries., Methods: Questionnaires based on eight clinical scenarios of commonly encountered cervical, thoracic, and lumbar injuries were administered to 35 experienced spinal surgeons. Surgeons completed profile information and answered approximately one dozen questions for each case. Data were analyzed with SPSS software to determine the levels of agreement and characteristics of respondents that might account for a lack of agreement on particular aspects of management., Results: Of the 35 surgeons completing the questionnaire, 63% were orthopedists, 37% were neurosurgeons, and 80% had been in practice for more than 5 years. Considerable agreement was found in the majority of clinical decisions, including whether or not to operate and the timing of surgery. Of the differences noted, neurosurgeons were more likely to obtain a MRI, and orthopedists were more likely to use autograft as a sole graft material. Physicians from abroad were, in general, more likely to operate and to use an anterior approach during surgery than physicians from the northeastern United States., Conclusions: More commonalities were identified in the management of spinal trauma than previously reported. When found, variability in opinion was related to professional and regional differences.