Utilization and Expenditures of Vertebral Augmentation Continue to Decline: An Analysis in Fee-For-Service (FFS) Recipients from 2009 to 2018.

BACKGROUND: Despite the high prevalence of vertebral compression fractures (VCFs) associated with refractory pain, deformity, or progressive neurological symptoms, minimally invasive vertebral augmentation procedures, including vertebroplasty and kyphoplasty, have been declining in their relative utilization, along with expenditures. OBJECTIVES: This investigation was undertaken to assess utilization and expenditures for vertebral augmentation procedures, including vertebroplasty and kyphoplasty, in the fee-for-service (FFS) Medicare population from 2009 to 2018. STUDY DESIGN: The present study was designed to assess utilization and expenditures in all settings, for all providers in the FFS Medicare population from 2009 to 2018 in the United States. In this manuscript:• A patient was described as receiving vertebral augmentation over the course of the year.• An episode was considered as one treatment per region per day utilizing primary codes only. • Services or procedures were considered to be procedures including multiple levels.A standard 5% national sample of the Centers for Medicare and Medicaid Services (CMS) physician outpatient billing claims data for those enrolled in the FFS Medicare program from 2009 to 2018 was utilized. All the expenditures were presented with allowed costs and adjusted for inflation to 2018 US dollars. RESULTS: In 2009, there were 76,860 episodes of vertebral augmentation with a rate of 168 per 100,000 Medicare population, which declined to 58,760, or 99 per 100,000 population for a total decline of 41%, or an annual rate of decline of 5.7% per 100,000 Medicare population. Vertebroplasty interventions declined more dramatically than kyphoplasty from 2009. Total episodes of vertebroplasty were 27,380 with an annual rate of 60 per 100,000 Medicare population, decreasing to 9,240, or 16 per 100,000 Medicare population, a 66% decline in episodes and a 74% decline in overall rate with an annual decline of 11.4% and 13.9%. In contrast, kyphoplasty interventions were 49,480, for a rate per 100,000 population of 108 in 2009 compared to 49,520 in 2018 with a rate of 83, for a decrease of 23% and 2.9% annual decrease. Evaluation of expenditures showed a net decrease of $30,102,809, or 8%, from $378,758,311 in 2009 to $348,655,502 in 2018. However, inflation-adjusted expenditures decreased overall by 21% and 3% annually from $443,147,324 in 2009 to $345,655,502 in 2018. In addition, inflation-adjusted total expenditures per 100,000 Medicare population decreased from $967,549 to $584,992, for an overall decrease of 40%, or an annual decrease of 5%. Per patient expenditures decreased 2% overall with 0% decrease per year. LIMITATIONS: Vertebral augmentation procedures were assessed only in the FFS Medicare service population. This excluded over 30% of the Medicare population, which is enrolled in Medicare Advantage plans. CONCLUSIONS: This study shows a significant decline in relative utilization patterns of vertebroplasty and kyphoplasty procedures, along with reductions in overall expenditures. The inflation-adjusted total expenditures of kyphoplasty and vertebroplasty decreased 21% with an annual decline of 3%. The inflation-adjusted expenditures per 100,000 of Medicare population decreased 40% overall and 5% per year. In addition, vertebroplasty has seen substantial declines in utilization and expenditure patterns compared to kyphoplasty procedures, which showed trends of decline.

A Comparative Systematic Review and Meta-Analysis of 3 Routes of Administration of Epidural Injections in Lumbar Disc Herniation.

BACKGROUND: The Best Practices in Pain Management from the U.S. Department of Health and Human Services (HHS) describes interventional techniques as part of a continuum. Epidural injections are commonly utilized modalities in managing low back and lower extremity pain. Epidural injections were initially administered in 1901 where the first descriptions of caudal epidural with local anesthetic for low back pain appeared. Since then, multiple developments have occurred. Currently, epidural injections are provided by caudal, interlaminar, and transforaminal approaches. The comparative effectiveness of each modality has been studied. However, comparative assessment has been sparse. OBJECTIVES: To assess the efficacy of 3 routes of administration of epidural injections for lumbar disc herniation. STUDY DESIGN: A systematic review and meta-analysis of randomized controlled trials (RCTs) of transforaminal, interlaminar and caudal epidural injections in managing chronic low back and lower extremity pain due to lumbar disc herniation. METHODS: RCTs with a placebo control or an active control design, performed under fluoroscopic guidance, with at least 6 months of follow-up are included. The outcome measures were pain relief and functional status improvement. Significant improvement was defined as 50% or greater pain relief and functional status improvement. Data extraction and methodological quality assessment were performed. Evidence was summarized utilizing principles of best evidence synthesis. RESULTS: A total of 21 trials were included. Of these, 7 studied caudal epidural injections, whereas transforaminal epidural injections were studied in 12 trials, and lumbar interlaminar epidural injections were studied in 10 trials, which all met inclusion criteria. Based on qualitative and quantitative analysis, which included conventional dual-arm and single-arm analysis for interlaminar epidural injections, and single-arm analysis for caudal and transforaminal epidural injections, and the approach to the epidural space, there is Level I evidence for local anesthetic and steroids, Level II for local anesthetic alone for transforaminal and interlaminar approaches, and Level II for the caudal approach with steroids or local anesthetic alone for short- and long-term relief. LIMITATIONS: There is a paucity of literature with intermediate or long-term relief of at least 6 months with appropriate outcome parameters. Conventional dual-arm meta-analysis was feasible only for interlaminar epidural injections. CONCLUSION: Epidural injections with local anesthetic and steroids showed Level I evidence for transforaminal and interlaminar approaches, whereas with local anesthetic alone Level II evidence was demonstrated. In contrast, caudal epidural injections showed Level II evidence with local anesthetic with steroids or local anesthetic alone.

Spinal Cord Stimulation Trends of Utilization and Expenditures in Fee-For-Service (FFS) Medicare Population from 2009 to 2018.

BACKGROUND: Spinal cord stimulation has been utilized with increasing frequency in managing chronic intractable spinal pain and complex regional pain syndrome (CRPS) in addition to other neuropathic pain states. The literature has shown the effectiveness of spinal cord stimulation in managing chronic pain with improvement in quality of life and cost utility. There have not been any reviews performed in the fee-for-service (FFS) Medicare population in reference to utilization and expenditure patterns of spinal cord stimulators. OBJECTIVES: This investigation was undertaken to assess the utilization and expenditures for spinal cord stimulation in the FFS Medicare population from 2009 to 2018. STUDY DESIGN: The present study was designed to assess the utilization patterns and expenditures in all settings, for all providers in the FFS Medicare population from 2009 to 2018 in the United States. A standard 5% national sample of the Centers for Medicare and Medicaid Services (CMS) physician outpatient billing claims data. All the expenditures were presented with allowed costs and adjusted to inflation to 2018 US dollars only trials and implants were included. RESULTS: Utilization patterns showed that spinal cord stimulation trials increased from 12,680 in 2009 to 36,280 in 2018, a 186% increase with an annual increase of 12.4%. The rate of trials per 100,000 population increased from 28 in 2009 to 61 in 2018 with a 120% increase, or an annual increase of 9.1%. The pulse generator implants increased from 7,640 in 2009 to 22,960 in 2018, an increase of 201%, with an annual increase of 13%. In addition, percutaneous placement with pulse generator implants increased from 4,080 in 2009 to 14,316 in 2018, a 252% increase, or 15% annual increase. In contrast, implantation of neurostimulator electrodes with paddle leads with laminectomy and placement of spinal pulse generator increased from 3,560 in 2009 to 8,600 in 2018, a 142% increase or an annual increase of 10.3%. Analysis of expenditures showed total inflation-adjusted expenditures increased from $292,153,701 in 2009 to $1,142,434,137 in 2018, a 291% increase from 2009 to 2018 and 16.4% annual increase. These expenditures were 125% higher than facet joint interventions and 138% higher than epidural interventions in 2018. In contrast, these expenditures were 55% below the expenditures of facet joint interventions and 66% lower than epidural injections in 2009.Trial to implant ratio improved from 42.5% in 2009 to 63.6% in 2018. An overwhelming majority of trials (90%) were performed by nonsurgical physicians, whereas, 56% of implants were performed by non-surgeons. LIMITATIONS: This assessment includes only FFS Medicare population, thus eliminating approximately 30% of the population with Medicare Advantage plans. In addition, this study has not taken into consideration various revisions not included in 3 specific codes. CONCLUSIONS: The analysis of spinal cord stimulators in the FFS Medicare population from 2009 to 2018 showed explosive increases of trials, implants and overall costs.

Lack of Superiority of Epidural Injections with Lidocaine with Steroids Compared to Without Steroids in Spinal Pain: A Systematic Review and Meta-Analysis.

BACKGROUND: Multiple randomized controlled trials (RCTs) and systematic reviews have been conducted to summarize the evidence for administration of local anesthetic (lidocaine) alone or with steroids, with discordant opinions, more in favor of equal effect with local anesthetic alone or with steroids. OBJECTIVE: To evaluate the comparative effectiveness of lidocaine alone and lidocaine with steroids in managing spinal pain to assess superiority or equivalency. STUDY DESIGN: A systematic review of RCTs assessing the effectiveness of lidocaine alone compared with addition of steroids to lidocaine in managing spinal pain secondary to multiple causes (disc herniation, radiculitis, discogenic pain, spinal stenosis, and post-surgery syndrome). METHODS: This systematic review was performed utilizing Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) for literature search, Cochrane review criteria, and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) to assess the methodologic quality assessment and qualitative analysis utilizing best evidence synthesis principles, and quantitative analysis utilizing conventional and single-arm meta-analysis. PubMed, Cochrane Library, US National Guideline Clearinghouse, Google Scholar, and prior systematic reviews and reference lists were utilized in the literature search from 1966 through December 2019. The evidence was summarized utilizing principles of best evidence synthesis on a scale of 1 to 5. OUTCOME MEASURES: A hard endpoint for the primary outcome was defined as the proportion of patients with 50% pain relief and improvement in function. Secondary outcome measures, or soft endpoints, were pain relief and/or improvement in function. Effectiveness was determined as short-term if it was less than 6 months. Improvement that lasted longer than 6 months, was defined as long-term. RESULTS: Based on search criteria, 15 manuscripts were identified and considered for inclusion for qualitative analysis, quantitative analysis with conventional meta-analysis, and single-arm meta-analysis. The results showed Level II, moderate evidence, for short-term and long-term improvement in pain and function with the application of epidural injections with local anesthetic with or without steroid in managing spinal pain of multiple origins. LIMITATIONS: Despite 15 RCTs, evidence may still be considered as less than optimal and further studies are recommended. CONCLUSION: Overall, the present meta-analysis shows moderate (Level II) evidence for epidural injections with lidocaine with or without steroids in managing spinal pain secondary to disc herniation, spinal stenosis, discogenic pain, and post-surgery syndrome based on relevant, high-quality RCTs. Results were similar for lidocaine, with or without steroids.

Steroid Distancing in Interventional Pain Management During COVID-19 and Beyond: Safe, Effective and Practical Approach.

BACKGROUND: Since the late 1940s, corticosteroids have been a mainstay class of agents in multiple interventional techniques and intra-articular injections. Exogenous glucocorticoids are structurally and pharmacologically similar to the endogenous hormones. As such, multiple actions of corticosteroids are exhibited, including those of anti-inflammatory and immunosuppressive effects. Epidural injections, with or without steroids, have been extensively used throughout the world. There are reports of epidural injections starting in 1901, with steroids being added to the local anesthetic since 1952, when steroids were administered into the sacral foramen. PURPOSE: Due to the extensive side effects of steroids in various injections, some have proposed limiting their use in epidurals and intraarticular injections. With the COVID-19 pandemic, the multiple side effects of the steroids have elevated the level of concern and recommendations have been made to utilize local anesthetic alone or the lowest dose of steroids. Fashioned from common expressions of the day, the term "steroid distancing" began to be used and proposed for intraarticular injections of the knee. Consequently, we sought to evaluate the evidence and feasibility of steroid distancing in interventional pain management. METHODS: This focused review of local anesthetics and steroids utilized in interventional pain management for epidural injections, peripheral nerve blocks, and intraarticular injections by multiple database searches. This is a focused narrative review and not a systematic review. Consequently, evidence synthesis was not performed traditionally, but was based on an overview of the available evidence. RESULTS: No significant difference was identified based on whether steroids are added to local anesthetic or not for epidural as well as facet joint injections. However, there was not enough evidence to compare these two groups for peripheral intraarticular injections. LIMITATIONS: The present review is limited by the paucity of literature with bupivacaine alone or bupivacaine with steroids local anesthetic alone or with steroids of intraarticular injections of knee, hip, shoulder and other joints, and intraarticular facet joint injections. CONCLUSION: This review shows an overall lack of significant difference between lidocaine alone and lidocaine with steroids in epidural injections. However, available evidence is limited for bupivacaine alone or with steroids. Evidence is also not available comparing local anesthetic alone with steroids for facet joint or peripheral joint intraarticular injections. Thus, it is concluded that local anesthetic with lidocaine may be utilized for epidural injections, with appropriate patient selection and steroids reserved for non-responsive patients with local anesthetic and with significant radiculitis.