Search

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. KEY WORDS: Osteoporosis, osteoporotic compression fracture, vertebroplasty, kyphoplasty, vertebral augmentation, expenditures, inflation-adjusted, utilization

Multiple publications have shown the significant impact of the COVID-19 pandemic on US healthcare and increasing costs over the recent years in managing low back and neck pain as well as other musculoskeletal disorders. The COVID-19 pandemic has affected many modalities of treatments, including those related to chronic pain management, including both interventional techniques and opioids. While there have not been assessments of utilization of interventional techniques specific to the ongoing COVID-19 pandemic, previous analysis published with data from 2000 to 2018 demonstrated a decline in utilization of interventional techniques from 2009 to 2018 of 6.7%, with an annual decline of 0.8% per 100,000 fee-for-service (FFS) in the Medicare population. During that same time, the Medicare population has grown by 3% annually.The objectives of this analysis include an evaluation of the impact of the COVID-19 pandemic, as well as an updated assessment of the utilization of interventional techniques in managing chronic pain in the Medicare population from 2010 to 2019, 2010 to 2020, and 2019 to 2020 in the FFS Medicare population of the United States.Utilization patterns and variables of interventional techniques with the impact of the COVID-19 pandemic in managing chronic pain were assessed from 2000 to 2020 in the FFS Medicare population of the United States.The data for the analysis was obtained from the master database from the Centers for MedicareMedicaid Services (CMS) physician/supplier procedure summary from 2000 to 2020.The results of the present investigation revealed an 18.7% decrease in utilization of all interventional techniques per 100,000 Medicare beneficiaries from 2019 to 2020, with a 19% decrease for epidural and adhesiolysis procedures, a 17.5% decrease for facet joint interventions and sacroiliac joint blocks, and a 25.4% decrease for disc procedures and other types of nerve blocks. The results differed from 2000 to 2010 with an annualized increase of 10.2% per 100,000 Medicare population compared to an annualized decrease of 0.4% from 2010 to 2019, and a 2.5% decrease from 2010 to 2020 for all interventional techniques. For epidural and adhesiolysis procedures decreases were more significant and annualized at 3.1% from 2010 to 2019, increasing the decline to 4.8% from 2010 to 2020. For facet joint interventions and sacroiliac joint blocks, the reversal of growth patterns was observed but maintained at an annualized rate increase of 2.1% from 2010 to 2019, which changed to a decrease of 0.01% from 2010 to 2020. Disc procedures and other types of nerve blocks showed similar patterns as epidurals with an 0.8% annualized reduction from 2010 to 2019, which was further reduced to 3.6% from 2010 to 2020 due to COVID-19.Data for the COVID-19 pandemic impact were available only for 2019 and 2020 and only the FFS Medicare population was utilized; utilization patterns in Medicare Advantage Plans, which constitutes almost 40% of the Medicare enrollment in 2020 were not available. Moreover, this analysis shares the limitations present in all retrospective reviews of claims based datasets.The decline driven by the COVID-19 pandemic was 18.7% from 2019 to 2020. Overall decline in utilization in interventional techniques from 2010 to 2020 was 22.0% per 100,000 Medicare population, with an annual diminution of 2.5%, despite an increase in the population rate of 3.3% annualized (38.9% overall) and Medicare enrollees of 33.4% and 2.9% annually.

Among the multiple causes of low back and lower extremity pain, sacroiliac joint pain has shown to be prevalent in 10% to 25% of patients with persistent axial low back pain without disc herniation, discogenic pain, or radiculitis. Over the years, multiple Current Procedural Terminology (CPT) codes have evolved with the inclusion of intraarticular injections, nerve blocks, and radiofrequency neurotomy, in addition to percutaneous sacroiliac joint fusions. Previous assessments of utilization patterns of sacroiliac joint interventions only included sacroiliac joint intraarticular injections, since the data was not available prior to the introduction of new codes. A recent assessment revealed an increase of 11.3%, and an annual increase of 1.2% per 100,000 Medicare population from 2009 to 2018, showing a decline in growth patterns. During the past 2 years, the COVID-19 pandemic has also had significant effects on the utilization patterns of sacroiliac joint interventions.The impact of the COVID-19 pandemic and analysis of growth patterns of sacroiliac joint interventions (intraarticular injections, nerve blocks, radiofrequency neurotomy, arthrodesis and fusion) was evaluated from 2010 to 2019 and 2010 to 2020, with a comparative analysis from 2019 to 2020 to assess the impact of the COVID-19 pandemic.To update utilization patterns of sacroiliac joint interventions with assessment of the impact of the COVID-19 pandemic.The Centers for Medicare and Medicaid Services (CMS) Physician/Supplier Procedure Summary (PSPS) Master dataset was utilized in the present analysis.The results of this evaluation demonstrated a significant impact of the COVID-19 pandemic with a 19.2% decrease of utilization of sacroiliac joint intraarticular injections from 2019 to 2020. There was a 23.3% increase in sacroiliac joint arthrodesis and a 5.3% decrease for sacroiliac joint fusions with small numbers from 2019 to 2020. However, data was not available for sacroiliac joint nerve blocks and sacroiliac joint radiofrequency neurotomy as these codes were incorporated in 2020. Overall, from 2010 to 2019, sacroiliac joint intraarticular injections showed an annual increase of 0.9% per 100,000 Medicare population. Sacroiliac joint arthrodesis and fusion showed an annual increase from 2010 to 2020 per 100,000 Medicare population of 29% for arthrodesis and 13.3% for fusion.Limitations of this study include a lack of inclusion of Medicare Advantage patients constituting approximately 30% to 40% of the overall Medicare population. As with all claims-based data analyses, this study is retrospective and thus potentially limited by bias. Finally, patients who are non-Medicare are not part of the dataset.The study shows the impact of the COVID-19 pandemic with a significant decrease of intraarticular injections of 19.2% from 2019 to 2020 per 100,000 Medicare population. These decreases of intraarticular injections are accompanied by a 5.3% decrease of fusion, but a 23.3% increase of arthrodesis from 2019 to 2020 per 100,000 Medicare population. Overall, the results showed an annual increase of 0.9% per 100,000 Medicare population for intraarticular injections, a 35.4% annual increase for sacroiliac joint arthrodesis and an increase of 15.5% for sacroiliac joint fusion from 2010 to 2019.

Background: Lumbar facet joints are a clinically important source of chronic low back pain. There have been extensive diagnostic accuracy studies, along with studies of influence on the diagnostic process, but most of them have utilized the acute pain model. One group of investigators have emphasized the importance of the chronic pain model and longer lasting relief with diagnostic blocks. Objective: To assess the diagnostic accuracy of lumbar facet joint nerve blocks with controlled comparative local anesthetic blocks and concordant pain relief with an updated assessment of the prevalence, false-positive rates, and a description of a philosophical paradigm shift from an acute to a chronic pain model. Study Design: Retrospective study to determine diagnostic accuracy, prevalence and falsepositive rates. Setting: A multidisciplinary, non-university based interventional pain management practice in the United States. Methods: Controlled comparative local anesthetic blocks were performed initially with 1% lidocaine, followed by 0.25% bupivacaine if appropriate response was obtained, in an operating room under fluoroscopic guidance utilizing 0.5 mL of lidocaine or bupivacaine at L3, L4 medial branches and L5 dorsal ramus. All patients non-responsive to lidocaine blocks were considered to be negative for facet joint pain. All patients were assessed after the diagnostic blocks were performed with ≥ 80% pain relief for their ability to perform previously painful movements. Results: The prevalence of lumbar facet joint pain in chronic low back pain was 34.1% (95% CI, 28.8%, 39.8%), with a false-positive rate of 49.8% (95% CI, 42.7%, 56.8%). This study also showed a single block prevalence rate of 67.9% (95% CI, 62.9%, 73.2%). Average duration of pain relief ≥ 80% was 6 days with lidocaine block and total relief of ≥ 50% of 32 days. With bupivacaine, the average duration of pain relief ≥ 80% was 13 days with total relief of ≥ 50% lasting for 55 days. Conclusion: This study demonstrated that the chronic pain model is more accurate and reliable with concordant pain relief. This updated assessment also showed prevalence and false-positive rates of 34.1% and 49.8%. Key words: Chronic spinal pain, lumbar facet or zygapophysial joint pain, facet joint nerve blocks, medial branch blocks, controlled comparative local anesthetic blocks, diagnostic accuracy, prevalence, false-positive rate

Background: Sacroiliac joint is one of the proven causes of low back and lower extremity pain. Prevalence estimates of sacroiliac joint pain range from 10% to 25% in patients with persistent axial low back pain without disc herniation, discogenic pain, or radiculitis based on multiple diagnostic studies and systematic reviews. Over the years, utilization patterns of sacroiliac joint injections have been increasing in comparison to other interventional techniques. Further, the development of new current procedural terminology (CPT) codes and coverage policies for sacroiliac joint nerve blocks, sacroiliac joint radiofrequency neurotomy, and evolving evidence for sacroiliac joint fusion will further increase the utilization patterns. Study Design: Analysis of growth patterns of sacroiliac joint injections from 2000 to 2018 with comparative analysis of 2000 to 2009 and 2009 to 2018. Objectives: To assess utilization patterns of sacroiliac joint injections from 2000 to 2018. Methods The Centers for Medicare and Medicaid Services (CMS) Physician/Supplier Procedure Summary (PSPS) Master dataset was utilized in this analysis. Results: The results of the evaluation from 2009 to 2018 showed an increase of 11.3% and an annual increase of 1.2% per 100,000 Medicare population. However, from 2000 to 2009, an increase of 299.8% from 2000 to 2009 with an annual increase of 16.6% per 100,000 Medicare population. Limitations: The limitations of this study included a lack of data on the new sacroiliac joint nerve block and radiofrequency neurotomy codes. Further, this data did not include utilization patterns of sacroiliac joint fusions. In addition, Medicare Advantage patients were not included, which constitute approximately 30% of overall Medicare population. Further, there is also a possibility that state claims data may include claims from other states. As with all claims-based data analyses, this study is retrospective and thus potentially limited by bias. Finally, patients who are self or commercially insured are not part of the dataset. Conclusions: This study shows increases in utilization patterns of sacroiliac joint injections; however, at a significantly lower rate with an annual increase of 16.6% prior to 2009 and only 1.2% from 2009 to 2018 per 100,000 Medicare beneficiaries Key words: Chronic spinal pain, low back pain, sacroiliac joint arthritis, interventional techniques, sacroiliac joint injections

Background: Chronic axial spinal pain is one of the major causes of significant disability and health care costs, with facet joints as one of the proven causes of pain. Objective: To provide evidence-based guidance in performing diagnostic and therapeutic facet joint interventions. Methods: The methodology utilized included the development of objectives and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of facet joint interventions, was reviewed, with a best evidence synthesis of available literature and utilizing grading for recommendations. Summary of Evidence and Recommendations: Non-interventional diagnosis: • The level of evidence is II in selecting patients for facet joint nerve blocks at least 3 months after onset and failure of conservative management, with strong strength of recommendation for physical examination and clinical assessment. • The level of evidence is IV for accurate diagnosis of facet joint pain with physical examination based on symptoms and signs, with weak strength of recommendation. Imaging: • The level of evidence is I with strong strength of recommendation, for mandatory fluoroscopic or computed tomography (CT) guidance for all facet joint interventions. • The level of evidence is III with weak strength of recommendation for single photon emission computed tomography (SPECT) . • The level of evidence is V with weak strength of recommendation for scintography, magnetic resonance imaging (MRI), and computed tomography (CT) . Interventional Diagnosis: Lumbar Spine: • The level of evidence is I to II with moderate to strong strength of recommendation for lumbar diagnostic facet joint nerve blocks. • Ten relevant diagnostic accuracy studies with 4 of 10 studies utilizing controlled comparative local anesthetics with concordant pain relief criterion standard of ≥ 80% were included. • The prevalence rates ranged from 27% to 40% with false-positive rates of 27% to 47%, with ≥ 80% pain relief.Limitations: The limitations of these guidelines include a paucity of high-quality studies in the majority of aspects of diagnosis and therapy. Conclusions: These facet joint interventions guidelines were prepared with a comprehensive review of the literature with methodologic quality assessment with determination of level of evidence and strength of recommendations Key words: Chronic spinal pain, interventional techniques, diagnostic blocks, therapeutic interventions, facet joint nerve blocks, intraarticular injections, radiofrequency neurolysis

Background: The trends of the expenditures of facet joint interventions have not been specifically assessed in the fee-for-service (FFS) Medicare population since 2009 Objectives: The objective of this investigation is to assess trends of expenditures and utilization of facet joint interventions in FFS Medicare population from 2009 to 2018. Study Design: The study was designed to analyze trends of expenditures and utilization of facet joint interventions in FFS Medicare population from 2009-2018 in the United States. In this manuscript: • A patient was considered as undergoing facet joint interventions throughout the year. • A visit included all regions treated during the visit. • An episode was considered as one per region utilizing primary codes only. • Services or procedures were considered all procedures (multiple levels). Data for the analysis was obtained from the standard 5% national sample of the Centers for Medicare & Medicaid Services (CMS) physician outpatient billing claims for those enrolled in the FFS Medicare program from 2009 to 2018. All the expenditures were presented with allowed costs and also were inflation adjusted to 2018 US dollars. Results: This analysis showed expenditures increased by 79% from 2009 to 2018 in the form of total cost for facet joint interventions, at an annual rate of 6.7%. Cervical and lumbar radiofrequency neurotomy procedures increased 185% and 169%. However, inflation-adjusted expenditures with 2018 US dollars showed an overall increase of 53% with an annual increase of 4.9%. In addition, using inflation-adjusted expenditures per procedures increased, the overall 6% with an annual increase of 0.7%. Overall, per patient costs, with inflation adjustment, decreased from $1,925 to $1,785 with a decline of 7% and an annual decline of 0.8%. Allowed charges per visit also declined after inflation adjustment from $951.76 to $849.86 with an overall decline of 11% and an annual decline of 1.3%. Staged episodes of radiofrequency neurotomy were performed in 23.9% of patients and more than 2 episodes for radiofrequency neurotomy in 6.9%, in lumbar spine and 19.6% staged and 5.1% more than 2 episodes in cervical spine of patients in 2018. Limitations: This analysis is limited by inclusion of only the FFS Medicare population, without adding utilization patterns of Medicare Advantage plans, which constitutes almost 30% of the Medicare population. Conclusions: Even after adjusting for inflation, there was a significant increase for the expenditures of facet joint interventions with an overall 53% increase. Costs per patient and cost per visit declined. Inflation-adjusted cost per year declined 7% overall and 0.8% annually from $1,925 to $1,785, and inflation-adjusted cost per visit also declined 11% annually and 1.3% per year from $952 in 2009 to $850 in 2018. Key words: Facet joint interventions, facet joint nerve blocks, facet joint neurolysis, facet joint injections, Medicare expenditures

BACKGROUND The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration's (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine. OBJECTIVES The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around "minimal manipulation" and "homologous use" within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine. METHODS The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. RESULTS/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption. Statement 2: Assessment of clinical effectiveness based on extensive literature shows emerging evidence for multiple musculoskeletal and spinal conditions. • The evidence is highest for knee osteoarthritis with level II evidence based on relevant systematic reviews, randomized controlled trials and nonrandomized studies. There is level III evidence for knee cartilage conditions. • Based on the relevant systematic reviews, randomized trials, and nonrandomized studies, the evidence for disc injections is level III. • Based on the available literature without appropriate systematic reviews or randomized controlled trials, the evidence for all other conditions is level IV or limited for BMC injections. Statement 3: Based on an extensive review of the literature, there is strong evidence for the safety of BMC when performed by trained physicians with the appropriate precautions under image guidance utilizing a sterile technique. Statement 4: Musculoskeletal disorders and spinal disorders with related disability for economic and human toll, despite advancements with a wide array of treatment modalities. Statement 5: The 21st Century Cures Act was enacted in December 2016 with provisions to accelerate the development and translation of promising new therapies into clinical evaluation and use. Statement 6: Development of cell-based therapies is rapidly proliferating in a number of disease areas, including musculoskeletal disorders and spine. With mixed results, these therapies are greatly outpacing the evidence. The reckless publicity with unsubstantiated claims of beneficial outcomes having putative potential, and has led the FDA Federal Trade Commission (FTC) to issue multiple warnings. Thus the US FDA is considering the appropriateness of using various therapies, including BMC, for homologous use. Statement 7: Since the 1980's and the description of mesenchymal stem cells by Caplan et al, (now called medicinal signaling cells), the use of BMC in musculoskeletal and spinal disorders has been increasing in the management of pain and promoting tissue healing. Statement 8: The Public Health Service Act (PHSA) of the FDA requires minimal manipulation under same surgical procedure exemption. Homologous use of BMC in musculoskeletal and spinal disorders is provided by preclinical and clinical evidence. Statement 9: If the FDA does not accept BMC as homologous, then it will require an Investigational New Drug (IND) classification with FDA (351) cellular drug approval for use. Statement 10: This literature review and these position statements establish compliance with the FDA's intent and corroborates its present description of BMC as homologous with same surgical exemption, and exempt from IND, for use of BMC for treatment of musculoskeletal tissues, such as cartilage, bones, ligaments, muscles, tendons, and spinal discs. CONCLUSIONS Based on the review of all available and pertinent literature, multiple position statements have been developed showing that BMC in musculoskeletal disorders meets the criteria of minimal manipulation and homologous use. KEY WORDS Cell-based therapies, bone marrow concentrate, mesenchymal stem cells, medicinal signaling cells, Food and Drug Administration, human cells, tissues, and cellular tissue-based products, Public Health Service Act (PHSA), minimal manipulation, homologous use, same surgical procedure exemption.

Background: Interventional techniques for managing spinal pain, from conservative modalities to surgical interventions, are thought to have been growing rapidly. Interventional techniques take center stage in managing chronic spinal pain. Specifically, facet joint interventions experienced explosive growth rates from 2000 to 2009, with a reversal of these growth patterns and in some settings, a trend of decline after 2009. Objectives: The objectives of this assessment of utilization patterns include providing an update of facet joint interventions in managing chronic spinal pain in the fee-for-service (FFS) Medicare population of the United States from 2000 to 2018. Study Design: The study was designed to assess utilization patterns and variables of facet joint interventions in managing chronic spinal pain from 2000 to 2018 in the FFS Medicare population in the United States. Methods: Data for the analysis were obtained from the master database from the Centers for Medicare & Medicaid Services (CMS) physician/supplier procedure summary from 2000 to 2018. Results: Facet joint interventions increased 1.9% annually and 18.8% total from 2009 to 2018 per 100,000 FFS Medicare population compared with an annual increase of 17% and overall increase of 309.9% from 2000 to 2009. Lumbosacral facet joint nerve block sessions or visits decreased at an annual rate of 0.2% from 2009 to 2018, with an increase of 15.2% from 2000 to 2009. In contrast, lumbosacral facet joint neurolysis sessions increased at an annual rate of 7.4% from 2009 to 2018, and the utilization rate also increased at an annual rate of 23.0% from 2000 to 2009. The proportion of lumbar facet joint blocks sessions to lumbosacral facet joint neurolysis sessions changed from 6.7 in 2000 to 1.9 in 2018. Cervical and thoracic facet joint injections increased at an annual rate of 0.5% compared with cervicothoracic facet neurolysis sessions of 8.7% from 2009 to 2018. Cervical facet joint injections increased to 4.9% from 2009 to 2018 compared with neurolysis procedures of 112%. The proportion of cervical facet joint injection sessions to neurolysis sessions changed from 8.9 in 2000 to 2.4 in 2018. Limitations: This analysis is limited by inclusion of only the FFS Medicare population, without adding utilization patterns of Medicare Advantage plans, which constitutes almost 30% of the Medicare population. The utilization data for individual states also continues to be sparse and may not be accurate. Conclusions: Utilization patterns of facet joint interventions increased 1.9% per 100,000 Medicare population from 2009 to 2018. This results from an annual decline of - 0.2% lumbar facet joint injection sessions but with an increase of facet joint radiofrequency sessions of 7.4%. Key words: Interventional techniques, facet joint interventions, facet joint nerve blocks, facet joint neurolysis

Background: With increasing costs of health care in the United States, attention is focused on expensive conditions. Musculoskeletal disorders with low back and neck pain account for the third highest amount of various disease categories. Minimally invasive interventional techniques for managing spinal pain, including epidural injections, have been considered to be growing rapidly. However, recent analyses of utilization of interventional techniques from 2000 to 2018 has shown a decline of 2.6% and a decline of 21% from 2009 to 2018 for epidural and adhesiolysis procedures. Objectives: The objectives of this analysis of epidural procedures from 2000 to 2018 are to provide an update on utilization of epidural injections in managing chronic pain in the fee-forservice (FFS) Medicare population, with a comparative analysis of 2000 to 2009 and 2009 to 2018. Study Design: Utilization patterns and variables of epidural injections in managing chronic spinal pain from 2000 to 2009 and from 2009 to 2018 in the FFS Medicare population in the United States. Methods: This analysis was performed by utilizing master data from CMS, physician/supplier procedure summary from 2000 to 2018. The analysis was performed by the assessment of utilization patterns using guidance from Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). Results: Overall, epidural procedures declined at a rate of 20.7% per 100,000 Medicare enrollees in FFS Medicare in the United States from 2009 to 2018, with an annual decline of 2.5%. However, from 2000 to 2009, there was an increase of 89.2%, with an annual increase of 7.3%. This analysis showed a decline in all categories, with an annual decrease of 4.7% for lumbar interlaminar and caudal epidural injections, 4.7% decline for cervical/thoracic transforaminal epidural injections, 1.1% decline for lumbar/sacral transforaminal epidural injections, and finally 0.4% decline for cervical/thoracic interlaminar epidural injections. Overall declines from 2009 to 2018 were highest for cervical and thoracic transforaminal injections with 35.1%, followed by lumbar interlaminar and caudal epidural injections of 34.9%, followed by 9.4% for lumbar/sacral transforaminal epidurals, and 3.5% for cervical and thoracic interlaminar epidurals. Limitations: This analysis was limited by noninclusion of Medicare Advantage plans, which constitutes almost 30% of the Medicare population. In addition, utilization data for individual states continues to be sparse and may not be accurate or representative of the population. Conclusions: The declining utilization of epidural injections in all categories with an annual of 2.5% and overall decrease of 20.7% from 2009 to 2018 compared with annual increases of 7.3% and overall increase of 89.2% from 2000 to 2009 shows a slow decline of utilization of all epidural injections. Key words: Chronic spinal pain, interlaminar epidural injections, caudal epidural injections, transforaminal epidural injections, utilization patterns

As with many others in the house of medicine, the COVID-19 pandemic has adversely impacted the practice of interventional pain management. This in part relates to various state health authority or medical board restrictions with reductions in patient volume for evaluations, follow-ups, and procedures. Of course, the pandemic continues to persist which is in turn leading to longer-lasting effects. Our previous survey was performed in March 2020. At that time, there was a national lockdown in the United States with COVID-19 disease qualifying as a pandemic by the World Health Organization (WHO). The pandemic caused by COVID-19 disease continues to have far-reaching implications on how we deliver routine care to patients and its effect on patient care, economic aspects, and health of interventional pain management providers.To assess the current and expected future impact of the COVID-19 pandemic on interventional pain management practices in a physician survey. The study was performed based on performance in 2021 compared to the 2019 pre-COVID era.The American Society of Interventional Pain Physicians (ASIPP) administered a 16-question survey to their members by contacting them via a commercially available online marketing company platform. The survey was completed on www.constantcontact.com.The results showed that 88% of the providers experienced a reduction in income and a similar number expect decreases over the next 12 months. A large proportion of respondents (73.3%) reported a reduction in revenue of 11%-25%. In contrast, another 21.5% reported a revenue decline of 26%-50%, and 29% reported 11%-25% increase in expenses. Overall, new patient volume decreased 11%-25% based on the response from almost 63%, whereas almost 9% reported a decline of 26%-50%. In contrast, established patient volume declined 1%-10% as reported by 64% of the respondents, compared to an 11%-25% decrease by a small proportion of 14%. All interventional procedures showed significant decreases across the board, with 69% of the respondents reporting a decline in-office procedures, 64% in ambulatory surgery center (ASC) procedures, and 57% in hospital outpatient department (HOPD) procedures, ranging from 11%-25%.The survey included a relatively small number of member physicians which could introduce sampling error. Consequently, it may not be generalizable for other specialties or even to pain medicine.The COVID-19 pandemic has put interventional pain practices throughout the United States under considerable financial and psychological stress. This study seeks to quantify the extent of economic loss and other challenges resultant from the pandemic. Almost 99% reported a decrease in revenues in the last 12 months, with 86% reporting an expected reduction in the next 12 months and 49% reporting an increase in expenses. Declines have been reported in all sectors with new patients, office procedures, ASC, and HOPD procedures, except for established patient visits, which have shown minor declines compared to other domains. Understanding the issues facing interventional pain management physicians facilitates the development of strategies to actively manage provider practice/well-being, and to minimize risk to personnel to keep patients safe.

Chronic low back pain secondary to facet joint pathology is prevalent in 27% to 40% of selected populations using controlled comparative local anesthetic blocks. Lumbar facet joint nerve blocks and radiofrequency neurotomy are the most common interventional procedures for lower back pain. Nonetheless, questions remain regarding the effectiveness of each modality. Moreover, there is no agreement in reference to superiority or inferiority of lumbar facet joint nerve blocks when compared with radiofrequency neurotomy. Centers for Medicare and Medicaid Services (CMS) and almost all payers prefer radiofrequency ablation. Both procedures have been extensively studied with randomized controlled trials, systematic reviews, and cost utility analysis.To assess the clinical outcomes and cost utility of therapeutic lumbar facet joint nerve blocks (lumbar facet joint nerve blocks with L5 dorsal ramus block) compared with radiofrequency neurotomy in managing chronic low back pain of facet joint origin.A retrospective, case-control, comparative evaluation of outcomes and cost utility.The study was conducted in an interventional pain management practice, a specialty referral center, a private practice setting in the United States.The study was performed utilizing the Strengthening the Reporting of Observational Studies in Epidemiology Analysis (STROBE) criteria. Only the patients meeting the diagnostic criteria of facet joint pain by means of comparative, controlled diagnostic local anesthetic blocks were included.The main outcome measure was pain relief measured by the Numeric Rating Scale (NRS) evaluated at 3, 6, and 12 months. Significant improvement was defined as at least 50% improvement in pain relief. Cost utility was calculated utilizing direct payment data for the procedures with the addition of estimated indirect costs over a period of one year based on highly regarded surgical literature and previously published interventional pain management literature.A total of 326 patients met the inclusion criteria with 99 patients receiving lumbar facet joint nerve blocks (lumbar facet joint nerve blocks with L5 dorsal ramus block) and 227 receiving lumbar radiofrequency neurotomy. Forty-eight patients in the facet joint nerve block group and 148 patients in the radiofrequency group completed one-year follow-up. Patients experienced significant improvement in both groups from baseline to 12 months with significant pain relief (≥ 50%) Significant pain relief was recorded in 100%, 99%, and 79% of the patients in the facet joint nerve block group, whereas, it was 100%, 74%, and 65% in the radiofrequency neurotomy group at the 3, 6, and 12 month follow-up, with a significant difference at 6 months. Cost utility analysis showed average costs for quality-adjusted life year (QALY) of $4,664 for lumbar facet joint nerve blocks and $5,446 for lumbar radiofrequency neurotomy. Twelve patients (12%) in the lumbar facet joint nerve block group and 79 patients (35%) in the lumbar radiofrequency group were converted to other treatments, either due to side effects or inadequate relief.This study shows similar outcomes of therapeutic lumbar facet joint nerve blocks when compared with radiofrequency neurotomy as indicated by significant pain relief and cost utility.

Cervical facet joint pain is often managed with either cervical radiofrequency neurotomy, cervical medial branch blocks, or cervical intraarticular injections. However, the effectiveness of each modality continues to be debated. Further, there is no agreement in reference to superiority or inferiority of facet joint nerve blocks compared to radiofrequency neurotomy, even though cervical facet joint radiofrequency neurotomy has been preferred by many and in fact, has been mandated by the Centers for Medicare and Medicaid Services (CMS), except when radiofrequency cannot be confirmed. Each procedure has advantages and disadvantages in reference to clinical utility, outcomes, cost utility, and side effect profile. However, comparative analysis has not been performed thus far in the literature in a clinical setting.A retrospective, case-control, comparative evaluation of outcomes and cost utility.The study was conducted in an interventional pain management practice, a specialty referral center, a private practice setting in the United States.To evaluate the clinical outcomes and cost utility of therapeutic medial branch blocks with radiofrequency neurotomy in managing chronic neck pain of facet joint origin.The study was performed utilizing Strengthening the Reporting of Observational Studies in Epidemiology Analysis (STROBE) criteria. Only the patients meeting the diagnostic criteria of facet joint pain by means of comparative, controlled diagnostic local anesthetic blocks were included.The main outcome measure was pain relief measured by Numeric Rating Scale (NRS) evaluated at 3, 6, and 12 months. Significant improvement was defined as at least 50% improvement in pain relief. Cost utility was calculated with direct payment data for the procedures with addition of estimated indirect costs over a period of one year based on highly regarded surgical literature and previously published interventional pain management literature.Overall, 295 patients met inclusion criteria with 132 patients receiving cervical medial branch blocks and 163 patients with cervical radiofrequency neurotomy. One hundred and seven patients in the cervical medial branch group and 105 patients in the radiofrequency group completed one year follow-up. There was significant improvement in both groups from baseline to 12 months with pain relief and proportion of patients with= 50% pain relief. Average relief of each procedure for cervical medial branch blocks was 13 to 14 weeks, whereas for radiofrequency neurotomy, it was 20 to 25 weeks. Significant pain relief was recorded in 100%, 94%, and 81% of the patients in the medial branch blocks group, whereas it was 100%, 69%, and 64% in the radiofrequency neurotomy group at 3, 6, and 12 month follow-up, with significant difference at 6 and 12 months.Cost utility analysis showed average cost for quality-adjusted life year (QALY) of $4,994 for cervical medial branch blocks compared to $5,364 for cervical radiofrequency neurotomy. Six of 132 patients (5%) in the cervical medial branch group and 53 of 163 (33%) patients in the cervical radiofrequency neurotomy group were converted to other treatments, either due to side effects (6 patients or 4%) or inadequate relief (47 patients or 29%).In this study, outcomes of cervical therapeutic medial branch blocks compared to radiofrequency neurotomy demonstrated significantly better outcomes with significant pain relief with similar costs for both treatments over a period of one year.

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.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.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.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.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.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.

Background: The cost of US health care continues to increase, with treatments related to low back and neck pain and other musculoskeletal disorders accounting for the third highest amount of various disease categories. Interventional techniques for managing pain apart from conservative modalities and surgical interventions, have generally been thought to be growing rapidly. However, a recent analysis of utilization of interventional techniques from 2000 to 2016 has shown a modest decline from 2009 to 2016, compared to 2000 to 2009. Objectives: The objectives of this analysis include providing an update on utilization of interventional techniques in managing chronic pain in the Medicare population from 2009 to 2018 in the fee-for-service (FFS) Medicare population of the United States. Study Design: Utilization patterns and variables of interventional techniques in managing chronic pain were assessed from 2000 to 2009 and from 2009 to 2018 in the FFS Medicare population of the United States. Methods: The data for the analysis was obtained from the master database from the Centers for Medicare & Medicaid Services (CMS) physician/supplier procedure summary from 2000 to 2018. Results: The analysis of data showed that there was a decline in utilization of interventional techniques from 2009 to 2018 of 6.7%, with an annual decline of 0.8% per 100,000 FFS Medicare population, despite an increase of 0.7% per year of population growth (3.2% of those 65 years or older) and a 3% annual increase in Medicare participation from 2009 to 2018. Medicare data from 2000 to 2009 showed an increase of 11.8% per year per 100,000 individuals of the Medicare population. The 2009 to 2018 data also showed a 2.6% annual decrease in the rate of utilization of epidural and adhesiolysis procedures per 100,000 population of FFS Medicare, and a 1% decrease for disc procedures and other types of nerve blocks, while there was an increase of 0.9% annually for facet joint interventions and sacroiliac joint blocks. Limitations: Limitations of this analysis include: only the Medicare population was utilized, and among the Medicare population, only the FFS population was evaluated; utilization patterns in Medicare Advantage Plans, which constitutes almost 30% of the population were not considered. Further, the utilization data for individual states was sparse and may not be accurate. Conclusion: The decline in utilization of interventional techniques continued from 2009 to 2018 with 6.7% per 100,000 Medicare population, with an annual decline of 0.8%, despite an increase in the population rate and Medicare enrollees of 0.7% and 3% annually. Key words: Interventional pain management, chronic spinal pain, interventional techniques, epidural injections, adhesiolysis, facet joint interventions, sacroiliac joint injections, disc procedures, other types of nerve blocks

Background: Neck pain is one of the major conditions attributing to overall disability in the United States. There have been multiple publications assessing clinical and cost effectiveness of multiple modalities of interventions in managing chronic neck pain. Even then, the literature has been considered sparse in relation to cervical interlaminar epidural injections in managing chronic neck pain. In contrast, cost utility studies of lumbar interlaminar injections, caudal epidural injections, cervical and lumbar facet joint nerve blocks, percutaneous adhesiolysis demonstrated costs of less than $3,500 for quality-adjusted life year (QALY). Objectives: To assess the cost utility of cervical interlaminar epidural injections in managing chronic neck and/or upper extremity pain secondary to cervical disc herniation, post-surgery syndrome in neck, and axial or discogenic neck pain. Study Design: Analysis based on 3 previously published randomized trials of the effectiveness of cervical interlaminar epidural injections assessing their role in disc herniation, cervical post-surgery syndrome, and axial or discogenic pain. Setting: A contemporary, private, specialty referral interventional pain management center in the United States. Methods: Cost utility of cervical interlaminar epidural injections with or without steroids in managing cervical disc herniation, cervical post-surgery syndrome, and cervical discogenic or axial neck back pain was conducted with data derived from 3 randomized controlled trials (RCTs) that included a 2-year follow-up, with inclusion of 356 patients. The primary outcome was significant improvement defined as at least 50% in pain reduction and disability status. Direct payment data from all carriers from 2018 was utilized for the assessment of procedural costs. Overall costs, including drug costs, were determined by multiplication of direct procedural payment data by a factor of 1.67 to accommodate for indirect payments respectively for disc herniation, discogenic pain, and cervical post-surgery syndrome. Results: The results of the 3 RCTs showed direct cost utility for one year of QALY of $2,412.31 for axial or discogenic pain without disc herniation, $2,081.07 for disc herniation, and $2,309.20 for post surgery syndrome, with an average cost per one year QALY of $2,267.57, with total estimated overall costs with addition of indirect costs of $3,475.38, $4,028.55, $3,856.36, and $3,785.89 respectively. Limitations: The limitation of this cost utility analysis includes that it is a single center evaluation. Indirect costs were extrapolated. Conclusion: This cost utility analysis of cervical interlaminar epidural injections in patients nonresponsive to conservative management in the treatment of disc herniation, post surgery syndrome and axial or discogenic neck pain shows $2,267.57 for direct costs with a total cost of $3,785.89 per QALY. Key words: Cervical interlaminar epidural injections, chronic neck pain, cervical disc herniation, cervical discogenic pain, post surgery syndrome, cost utility analysis, cost effectiveness analysis, quality-adjusted life years

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.This investigation was undertaken to assess the utilization and expenditures for spinal cord stimulation in the FFS Medicare population from 2009 to 2018.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.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.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.The analysis of spinal cord stimulators in the FFS Medicare population from 2009 to 2018 showed explosive increases of trials, implants and overall costs.

Percutaneous epidural adhesiolysis is a minimally invasive therapeutic modality used in the treatment of patients with chronic low back and lower extremity pain, often recalcitrant to other modalities including epidural injections and surgical interventions. While the initial utilization since its introduction and development of appropriate Current Procedural Terminology (CPT) codes increased up until 2008, but since 2009, there has been a significant decline in utilization of these procedures in the Medicare population. These procedures declined by 53.2% at an annual rate of 10.3% from 2009 to 2016. A recent update analysis on the reversal and decline of growth of utilization of interventional techniques in managing chronic pain in the Medicare population from 2009 to 2018 revealed an even further decline of adhesiolysis procedures.An analysis of the utilization patterns of percutaneous adhesiolysis procedures in managing chronic low back and lower extremity pain in the Medicare population from 2000 to 2018, with comparative analysis from 2000 to 2009 and 2009 to 2018.To assess the utilization patterns of percutaneous adhesiolysis in managing chronic low back pain in the Medicare population.The Centers for Medicare and Medicaid Services (CMS) Physician Supplier Procedure Summary Master of Fee-For-Service (FFS) Data from 2000 to 2018 was used.In this analysis, various variables were assessed in reference to usage patterns of percutaneous adhesiolysis procedures with analysis of growth or declining utilization patterns. We also assessed specialty-based utilization, as well as statewide utilization.The decline of percutaneous adhesiolysis procedures began in 2009 and has continued since then. From 2009 to 2018, the overall decline was 69.2%, with an annual decline of 12.3% compared to an overall 62.6% increase from 2000 to 2009, with an annual increase of 5.6%. Compared to multiple other interventions, including epidural injections and facet joint interventions, percutaneous adhesiolysis has declined at a rapid rate.This assessment in the FFS Medicare population in the United States shows an irreversible decline of utilization of percutaneous adhesiolysis procedures, which has been gradually deteriorating with a 69.2% decline from 2009 to 2018 with an annual decline of 12.3% during that same time period.

Despite epidurals being one of the most common interventional pain procedures for managing chronic spinal pain in the United States, expenditure analysis lacks assessment in correlation with utilization patterns.This investigation was undertaken to assess expenditures for epidural procedures in the fee-for-service (FFS) Medicare population from 2009 to 2018.The present study was designed to assess 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 epidural procedures throughout the year.• A visit was considered to include all regions treated during the visit. • An episode was considered as one treatment per region utilizing primary codes only.• Services or procedures were considered as all procedures including bilateral and 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 to inflation to 2018 US dollars.Total expenditures were $723,981,594 in 2009, whereas expenditures of 2018 were $829,987,636, with an overall 14.6% increase, or an annual increase of 1.5%. However, the inflation-adjusted rate was $847,058,465 in 2009, compared to $829,987,636 in 2018, a reduction overall of 2% and an annual reduction of 0.2%. Inflation-adjusted per patient annual costs decreased from $988.93 in 2009 to $819.27 in 2018 with a decrease of 17.2% or an annual decline of 2.1%. In addition, inflation-adjusted costs per procedure decreased from $399.77 to $377.94, or 5.5% overall and 0.6% annually. Per procedure, episode, visit, and patient expenses were higher for transforaminal epidural procedures than lumbar interlaminar/caudal epidural procedures. Overall, costs of transforaminal epidurals increased 27.6% or 2.7% annually, whereas lumbar interlaminar and caudal epidural injections cost were reduced 2.7%, or 0.3% annually. Inflation-adjusted costs for transforaminal epidurals increased 9.1% or 1.0% annually and declined 16.9 or 2.0% annually for lumbar interlaminar and caudal epidural injections.Expenditures for epidural procedures in chronic spinal pain were assessed only in the FFS Medicare population. This excluded over 30% of the Medicare population, which is enrolled in Medicare Advantage plans.After adjusting for inflation, there was a decrease of expenditures for epidural procedures of 2%, or 0.2% annually, from 2009 to 2018. However, prior to inflation, the increases were noted at 14.6% and 1.5%. Inflation-adjusted costs per patient, per visit, and per procedure also declined. The proportion of Medicare patients per 100,000 receiving epidural procedures decreased 9.1%, or 1.1% annually. However, assessment of individual procedures showed higher costs for transforaminal epidural procedures compared to lumbar interlaminar and caudal epidural procedures.

Research into cervical spinal pain syndromes has indicated that the cervical facet joints can be a potent source of neck pain, headache, and referred pain into the upper extremities. There have been multiple diagnostic accuracy studies, most commonly utilizing diagnostic facet joint nerve blocks and an acute pain model, as Bogduk has proposed. Subsequently, Manchikanti has focused on the importance of the chronic pain model and longer lasting relief with diagnostic blocks.To assess diagnostic accuracy of cervical facet joint nerve blocks with controlled comparative local anesthetic blocks, with updated assessment of prevalence, false-positive rate, and a description of philosophical paradigm shift from acute to chronic pain model, with concordant pain relief.This diagnostic accuracy study was performed with retrospective assessment of data to assess prevalence and false-positive rates.The study was performed in a non-university-based, multidisciplinary, interventional pain management, private practice in the United States.Cervical medial branch blocks were performed utilizing lidocaine 1% followed by bupivacaine 0.25% when appropriate response was obtained in an operating room under fluoroscopic guidance with 0.5 mL of lidocaine or bupivacaine from C3-C6 medial branches (levels blocked on joints involved). If a patient failed to respond to lidocaine with appropriate= 80% pain relief, that patient was considered as negative for facet joint pain. If the response was positive with lidocaine block, a bupivacaine block was performed.The chronic cervical facet joint pain was diagnosed with cervical facet joint nerve blocks at a prevalence of 49.3% (95% CI, 43.6%, 55.0%) and with a false-positive rate of 25.6% (95% CI, 19.5%, 32.8%). This study also showed a single block prevalence rate of 66.3% (95% CI, 71.7%, 60.9%). Assessment of the duration of relief with each block showed greater than 80% for 6 days with lidocaine block and total relief of= 50% of 31 days. In contrast, with bupivacaine, average duration of pain relief of= 80% was 12 days with a total relief of= 50% lasting for 55 days.Based on this investigation, utilizing a chronic pain model, there was significant difference in the relief patterns. This assessment showed prevalence and false-positive rates of 49.3% and 25.6% in chronic neck pain. Duration of relief= 80% pain relief was 6 days with lidocaine and 12 days with bupivacaine, with total relief of= 50% of 31 days with 55 days respectively.

Lumbar facet joints are a clinically important source of chronic low back pain. There have been extensive diagnostic accuracy studies, along with studies of influence on the diagnostic process, but most of them have utilized the acute pain model. One group of investigators have emphasized the importance of the chronic pain model and longer lasting relief with diagnostic blocks.To assess the diagnostic accuracy of lumbar facet joint nerve blocks with controlled comparative local anesthetic blocks and concordant pain relief with an updated assessment of the prevalence, false-positive rates, and a description of a philosophical paradigm shift from an acute to a chronic pain model.Retrospective study to determine diagnostic accuracy, prevalence and false-positive rates.A multidisciplinary, non-university based interventional pain management practice in the United States.Controlled comparative local anesthetic blocks were performed initially with 1% lidocaine, followed by 0.25% bupivacaine if appropriate response was obtained, in an operating room under fluoroscopic guidance utilizing 0.5 mL of lidocaine or bupivacaine at L3, L4 medial branches and L5 dorsal ramus. All patients non-responsive to lidocaine blocks were considered to be negative for facet joint pain. All patients were assessed after the diagnostic blocks were performed with= 80% pain relief for their ability to perform previously painful movements.The prevalence of lumbar facet joint pain in chronic low back pain was 34.1% (95% CI, 28.8%, 39.8%), with a false-positive rate of 49.8% (95% CI, 42.7%, 56.8%). This study also showed a single block prevalence rate of 67.9% (95% CI, 62.9%, 73.2%). Average duration of pain relief= 80% was 6 days with lidocaine block and total relief of= 50% of 32 days. With bupivacaine, the average duration of pain relief= 80% was 13 days with total relief of= 50% lasting for 55 days.This study demonstrated that the chronic pain model is more accurate and reliable with concordant pain relief. This updated assessment also showed prevalence and false-positive rates of 34.1% and 49.8%.

The trends of the expenditures of facet joint interventions have not been specifically assessed in the fee-for-service (FFS) Medicare population since 2009.The objective of this investigation is to assess trends of expenditures and utilization of facet joint interventions in FFS Medicare population from 2009 to 2018.The study was designed to analyze trends of expenditures and utilization of facet joint interventions in FFS Medicare population from 2009-2018 in the United States. In this manuscript: • A patient was considered as undergoing facet joint interventions throughout the year. • A visit included all regions treated during the visit. • An episode was considered as one per region utilizing primary codes only. • Services or procedures were considered all procedures (multiple levels). Data for the analysis was obtained from the standard 5% national sample of the Centers for MedicareMedicaid Services (CMS) physician outpatient billing claims for those enrolled in the FFS Medicare program from 2009 to 2018. All the expenditures were presented with allowed costs and also were inflation adjusted to 2018 US dollars.This analysis showed expenditures increased by 79% from 2009 to 2018 in the form of total cost for facet joint interventions, at an annual rate of 6.7%. Cervical and lumbar radiofrequency neurotomy procedures increased 185% and 169%. However, inflation-adjusted expenditures with 2018 US dollars showed an overall increase of 53% with an annual increase of 4.9%. In addition, using inflation-adjusted expenditures per procedures increased, the overall 6% with an annual increase of 0.7%. Overall, per patient costs, with inflation adjustment, decreased from $1,925 to $1,785 with a decline of 7% and an annual decline of 0.8%. Allowed charges per visit also declined after inflation adjustment from $951.76 to $849.86 with an overall decline of 11% and an annual decline of 1.3%. Staged episodes of radiofrequency neurotomy were performed in 23.9% of patients and more than 2 episodes for radiofrequency neurotomy in 6.9%, in lumbar spine and 19.6% staged and 5.1% more than 2 episodes in cervical spine of patients in 2018.This analysis is limited by inclusion of only the FFS Medicare population, without adding utilization patterns of Medicare Advantage plans, which constitutes almost 30% of the Medicare population.Even after adjusting for inflation, there was a significant increase for the expenditures of facet joint interventions with an overall 53% increase. Costs per patient and cost per visit declined. Inflation-adjusted cost per year declined 7% overall and 0.8% annually from $1,925 to $1,785, and inflation-adjusted cost per visit also declined 11% annually and 1.3% per year from $952 in 2009 to $850 in 2018.Facet joint interventions, facet joint nerve blocks, facet joint neurolysis, facet joint injections, Medicare expenditures.

Chronic axial spinal pain is one of the major causes of significant disability and health care costs, with facet joints as one of the proven causes of pain.To provide evidence-based guidance in performing diagnostic and therapeutic facet joint interventions.The methodology utilized included the development of objectives and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of facet joint interventions, was reviewed, with a best evidence synthesis of available literature and utilizing grading for recommendations.Summary of Evidence and Recommendations:Non-interventional diagnosis: • The level of evidence is II in selecting patients for facet joint nerve blocks at least 3 months after onset and failure of conservative management, with strong strength of recommendation for physical examination and clinical assessment. • The level of evidence is IV for accurate diagnosis of facet joint pain with physical examination based on symptoms and signs, with weak strength of recommendation. Imaging: • The level of evidence is I with strong strength of recommendation, for mandatory fluoroscopic or computed tomography (CT) guidance for all facet joint interventions. • The level of evidence is III with weak strength of recommendation for single photon emission computed tomography (SPECT) . • The level of evidence is V with weak strength of recommendation for scintography, magnetic resonance imaging (MRI), and computed tomography (CT) .Interventional Diagnosis:Lumbar Spine: • The level of evidence is I to II with moderate to strong strength of recommendation for lumbar diagnostic facet joint nerve blocks. • Ten relevant diagnostic accuracy studies with 4 of 10 studies utilizing controlled comparative local anesthetics with concordant pain relief criterion standard of ≥80% were included. • The prevalence rates ranged from 27% to 40% with false-positive rates of 27% to 47%, with ≥80% pain relief.Cervical Spine: • The level of evidence is II with moderate strength of recommendation. • Ten relevant diagnostic accuracy studies, 9 of the 10 studies with either controlled comparative local anesthetic blocks or placebo controls with concordant pain relief with a criterion standard of ≥80% were included. • The prevalence and false-positive rates ranged from 29% to 60% and of 27% to 63%, with high variability. Thoracic Spine: • The level of evidence is II with moderate strength of recommendation. • Three relevant diagnostic accuracy studies, with controlled comparative local anesthetic blocks, with concordant pain relief, with a criterion standard of ≥80% were included. • The prevalence varied from 34% to 48%, whereas false-positive rates varied from 42% to 58%.Therapeutic Facet Joint Interventions: Lumbar Spine: • The level of evidence is II with moderate strength of recommendation for lumbar radiofrequency ablation with inclusion of 11 relevant randomized controlled trials (RCTs) with 2 negative studies and 4 studies with long-term improvement. • The level of evidence is II with moderate strength of recommendation for therapeutic lumbar facet joint nerve blocks with inclusion of 3 relevant randomized controlled trials, with long-term improvement. • The level of evidence is IV with weak strength of recommendation for lumbar facet joint intraarticular injections with inclusion of 9 relevant randomized controlled trials, with majority of them showing lack of effectiveness without the use of local anesthetic. Cervical Spine: • The level of evidence is II with moderate strength of recommendation for cervical radiofrequency ablation with inclusion of one randomized controlled trial with positive results and 2 observational studies with long-term improvement. • The level of evidence is II with moderate strength of recommendation for therapeutic cervical facet joint nerve blocks with inclusion of one relevant randomized controlled trial and 3 observational studies, with long-term improvement. • The level of evidence is V with weak strength of recommendation for cervical intraarticular facet joint injections with inclusion of 3 relevant randomized controlled trials, with 2 observational studies, the majority showing lack of effectiveness, whereas one study with 6-month follow-up, showed lack of long-term improvement. Thoracic Spine: • The level of evidence is III with weak to moderate strength of recommendation with emerging evidence for thoracic radiofrequency ablation with inclusion of one relevant randomized controlled trial and 3 observational studies. • The level of evidence is II with moderate strength of recommendation for thoracic therapeutic facet joint nerve blocks with inclusion of 2 randomized controlled trials and one observational study with long-term improvement. • The level of evidence is III with weak to moderate strength of recommendation for thoracic intraarticular facet joint injections with inclusion of one randomized controlled trial with 6 month follow-up, with emerging evidence. Antithrombotic Therapy: • Facet joint interventions are considered as moderate to low risk procedures; consequently, antithrombotic therapy may be continued based on overall general status. Sedation: • The level of evidence is II with moderate strength of recommendation to avoid opioid analgesics during the diagnosis with interventional techniques. • The level of evidence is II with moderate strength of recommendation that moderate sedation may be utilized for patient comfort and to control anxiety for therapeutic facet joint interventions.The limitations of these guidelines include a paucity of high-quality studies in the majority of aspects of diagnosis and therapy.These facet joint intervention guidelines were prepared with a comprehensive review of the literature with methodologic quality assessment with determination of level of evidence and strength of recommendations.Chronic spinal pain, interventional techniques, diagnostic blocks, therapeutic interventions, facet joint nerve blocks, intraarticular injections, radiofrequency neurolysis.

To review the utilization patterns of vertebral augmentation procedures in the US Medicare population from 2004 to 2017 surrounding concurrent developments in the literature and the enactment of the Affordable Care Act (ACA). The analysis of vertebroplasty and kyphoplasty utilization patterns was carried out using specialty utilization data from the Centers for Medicare and Medicaid Services Database. Of note, over the period of time between 2009 and 2017, the number of people aged 65 or older showed a 3.2% rate of annual increase, and the number of Medicare beneficiaries increased by 27.6% with a 3.1% rate of annual increase. Concurrently, vertebroplasty utilization decreased 72.8% (annual decline of 15% per 100,000 Medicare beneficiaries), and balloon kyphoplasty utilization decreased 19% (annual decline of 2.6% per 100,000 Medicare beneficiaries). This translates to a 38.3% decrease in vertebroplasty and balloon kyphoplasty utilization (annual decline of 5.9% per 100,000 Medicare beneficiaries) from 2009 to 2017. By contrast, from 2004 to 2009, there was a total 188% increase in vertebroplasty and balloon kyphoplasty utilization (annual increase rate of 23.6% per 100,000 Medicare beneficiaries). The majority of vertebroplasty procedures were done by radiologists, and the majority of kyphoplasties were done by aggregate groups of spine surgeons. These results illustrate a significant decline in vertebral augmentation procedures in the fee-for-service Medicare population between 2004 and 2017, with dramatic decreases following the publication of two 2009 trials that failed to demonstrate benefit of vertebroplasty over sham and the enactment of the ACA.

With increasing costs of health care in the United States, attention is focused on expensive conditions. Musculoskeletal disorders with low back and neck pain account for the third highest amount of various disease categories. Minimally invasive interventional techniques for managing spinal pain, including epidural injections, have been considered to be growing rapidly. However, recent analyses of utilization of interventional techniques from 2000 to 2018 has shown a decline of 2.6% and a decline of 21% from 2009 to 2018 for epidural and adhesiolysis procedures.The objectives of this analysis of epidural procedures from 2000 to 2018 are to provide an update on utilization of epidural injections in managing chronic pain in the fee-for-service (FFS) Medicare population, with a comparative analysis of 2000 to 2009 and 2009 to 2018.Utilization patterns and variables of epidural injections in managing chronic spinal pain from 2000 to 2009 and from 2009 to 2018 in the FFS Medicare population in the United States.This analysis was performed by utilizing master data from CMS, physician/supplier procedure summary from 2000 to 2018. The analysis was performed by the assessment of utilization patterns using guidance from Strengthening the Reporting of Observational Studies in Epidemiology (STROBE).Overall, epidural procedures declined at a rate of 20.7% per 100,000 Medicare enrollees in FFS Medicare in the United States from 2009 to 2018, with an annual decline of 2.5%. However, from 2000 to 2009, there was an increase of 89.2%, with an annual increase of 7.3%. This analysis showed a decline in all categories, with an annual decrease of 4.7% for lumbar interlaminar and caudal epidural injections, 4.7% decline for cervical/thoracic transforaminal epidural injections, 1.1% decline for lumbar/sacral transforaminal epidural injections, and finally 0.4% decline for cervical/thoracic interlaminar epidural injections. Overall declines from 2009 to 2018 were highest for cervical and thoracic transforaminal injections with 35.1%, followed by lumbar interlaminar and caudal epidural injections of 34.9%, followed by 9.4% for lumbar/sacral transforaminal epidurals, and 3.5% for cervical and thoracic interlaminar epidurals.This analysis was limited by noninclusion of Medicare Advantage plans, which constitutes almost 30% of the Medicare population. In addition, utilization data for individual states continues to be sparse and may not be accurate or representative of the population.The declining utilization of epidural injections in all categories with an annual of 2.5% and overall decrease of 20.7% from 2009 to 2018 compared with annual increases of 7.3% and overall increase of 89.2% from 2000 to 2009 shows a slow decline of utilization of all epidural injections.Chronic spinal pain, interlaminar epidural injections, caudal epidural injections, transforaminal epidural injections, utilization patterns.

The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration's (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine.The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around "minimal manipulation" and "homologous use" within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine.The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. RESULTS/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption. Statement 2: Assessment of clinical effectiveness based on extensive literature shows emerging evidence for multiple musculoskeletal and spinal conditions. • The evidence is highest for knee osteoarthritis with level II evidence based on relevant systematic reviews, randomized controlled trials and nonrandomized studies. There is level III evidence for knee cartilage conditions. • Based on the relevant systematic reviews, randomized trials, and nonrandomized studies, the evidence for disc injections is level III. • Based on the available literature without appropriate systematic reviews or randomized controlled trials, the evidence for all other conditions is level IV or limited for BMC injections. Statement 3: Based on an extensive review of the literature, there is strong evidence for the safety of BMC when performed by trained physicians with the appropriate precautions under image guidance utilizing a sterile technique. Statement 4: Musculoskeletal disorders and spinal disorders with related disability for economic and human toll, despite advancements with a wide array of treatment modalities. Statement 5: The 21st Century Cures Act was enacted in December 2016 with provisions to accelerate the development and translation of promising new therapies into clinical evaluation and use. Statement 6: Development of cell-based therapies is rapidly proliferating in a number of disease areas, including musculoskeletal disorders and spine. With mixed results, these therapies are greatly outpacing the evidence. The reckless publicity with unsubstantiated claims of beneficial outcomes having putative potential, and has led the FDA Federal Trade Commission (FTC) to issue multiple warnings. Thus the US FDA is considering the appropriateness of using various therapies, including BMC, for homologous use. Statement 7: Since the 1980's and the description of mesenchymal stem cells by Caplan et al, (now called medicinal signaling cells), the use of BMC in musculoskeletal and spinal disorders has been increasing in the management of pain and promoting tissue healing. Statement 8: The Public Health Service Act (PHSA) of the FDA requires minimal manipulation under same surgical procedure exemption. Homologous use of BMC in musculoskeletal and spinal disorders is provided by preclinical and clinical evidence. Statement 9: If the FDA does not accept BMC as homologous, then it will require an Investigational New Drug (IND) classification with FDA (351) cellular drug approval for use. Statement 10: This literature review and these position statements establish compliance with the FDA's intent and corroborates its present description of BMC as homologous with same surgical exemption, and exempt from IND, for use of BMC for treatment of musculoskeletal tissues, such as cartilage, bones, ligaments, muscles, tendons, and spinal discs.Based on the review of all available and pertinent literature, multiple position statements have been developed showing that BMC in musculoskeletal disorders meets the criteria of minimal manipulation and homologous use.Cell-based therapies, bone marrow concentrate, mesenchymal stem cells, medicinal signaling cells, Food and Drug Administration, human cells, tissues, and cellular tissue-based products, Public Health Service Act (PHSA), minimal manipulation, homologous use, same surgical procedure exemption.

Chronic thoracic pain, even though not as prevalent as low back and neck pain, appears in approximately 30% of the general population. The severity of thoracic pain and degree of disability seems to be similar to other painful conditions. Despite this severity, interventions in managing chronic thoracic pain are less frequent, and there is a paucity of literature regarding epidural injections and facet joint interventions. As with lumbar and cervical spine, a multitude of interventions are offered in managing chronic thoracic pain, including interventional techniques with epidural injections and facet joint interventions. A single randomized controlled trial (RCT) has been published with a 2-year follow-up of clinical effectiveness of the results. However, there have not been any cost-utility analysis studies pertaining to either epidural injections or facet joint interventions in thoracic pain. Based on the results of the RCT, a cost-utility analysis of thoracic interlaminar epidural injections was undertaken. Evaluation of the cost-utility analysis of thoracic interlaminar epidural injections with or without steroids in managing thoracic disc herniation, thoracic spinal stenosis, and thoracic discogenic or axial pain was assessed in 110 patients with a 2-year follow-up. Direct payment data from 2018 was utilized for procedural costs and indirect costs. Costs, including drug costs, were determined by multiplication of direct procedural payment data by a factor of 1.67 or addition of 40% of cost to accommodate for indirect payments and arrive at overall costs. Cost-utility analysis showed direct procedural cost of USD $1943.19, whereas total estimated costs year per QALY were USD $3245.12.

Background: Several cell-based therapies have been proposed in recent years the management of low back pain, including the injection of medicinal signaling cells or mesenchymal stem cells (MSCs) and platelet-rich plasma (PRP). However, there is only emerging clinical evidence to support their use at this time. Purpose: To assess the effectiveness of MSCs or PRP injections in the treatment of low back and lower extremity pain. Study Design: A systematic review and metaanalysis of the effectiveness of PRP and MSCs injections in managing low back and lower extremity pain. Data Sources: PubMed, Cochrane Library, US National Guideline Clearinghouse, prior systematic reviews, and reference lists. The literature search was performed from 1966 through June 2018. Study Selection: Randomized trials, observational studies, and case reports of injections of biologics into the disc, epidural space, facet joints, or sacroiliac joints. Data Extraction: Data extraction and methodological quality assessment were performed utilizing Cochrane review methodologic quality assessment and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) and Interventional Pain Management Techniques – Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR). The evidence was summarized utilizing principles of best evidence synthesis on a scale of 1 to 5. Data Synthesis: Twenty-one injection studies met inclusion criteria. There were 12 lumbar disc injections, 5 epidural, 3 lumbar facet joint, and 3 sacroiliac joint studies Results: Evidence synthesis based on a single-arm metaanalysis, randomized controlled trials (RCTs), and observational studies, disc injections of PRP and MSCs showed Level 3 evidence (on a scale of Level I through V). Evidence for epidural injections based on single-arm metaanalysis, a single randomized controlled trial and other available studies demonstrated Level 4 (on a scale of Level I through V) evidence. Similarly, evidence for lumbar facet joint injections and sacroiliac joint injections without metaanalysis demonstrated Level 4 evidence (on a scale of Level I through V).. Limitations: Lack of high quality RCTs. Conclusion: The findings of this systematic review and single-arm metaanalysis shows that MSCs and PRP may be effective in managing discogenic low back pain, radicular pain, facet joint pain, and sacroiliac joint pain, with variable levels of evidence in favor of these techniques. Key Words: Chronic low back pain, regenerative therapy, medicinal signaling or mesenchymal stem cells, platelet-rich plasma, disc injection, lumbar facet joint injections, sacroiliac joint injections

Background: Neck and back pain are leading sources of disability placing substantial burden on health care systems. Surgical interventions in managing chronic neck pain secondary to various disorders continue to increase. Even though surgical interventions are effective, a significant proportion of patients continue to have symptomatology and develop cervical post-surgery syndrome. This study was performed to know the effectiveness of cervical interlaminar epidural injections with or without steroids. Methods: The effectiveness of fluoroscopic cervical interlaminar epidural injections in post-surgery syndrome was evaluated in a randomized, active controlled trial. The study population included 116 patients assigned to 2 groups. Group 1 received cervical interlaminar epidural injections with local anesthetic alone and Group 2 received injection with local anesthetic and steroids. The main outcomes were defined as significant improvement (greater than 50%) of pain relief using the numeric rating scale and/or functional status improvement using the Neck Disability Index (NDI). Results: Both groups had similar results with significant improvement (≥ 50% pain relief and functional status improvement) in 69% of the patients in Group I, whereas, in Group II, 71% of the patients showed significant improvement at the end of 2 years. During a 2-year period, the average number of procedures was 5 to 6, with an average of approximately 12 weeks of significant improvement per procedure. Conclusions: Fluoroscopic cervical interlaminar epidural injections administered in cervical post-surgery syndrome using local anesthetic, regardless of the use of steroids, may be effective in approximately 70% of the patients at 2-year follow-up. (Korean J Pain 2018; 31: 277-88)

On July 12, 2018, the Centers for Medicare and Medicaid Services (CMS) released the proposed 2019 Medicare physician fee schedule and quality payment program, combining these 2 rules for the first time. This occurred in a milieu of changing regulations that have been challenging for interventional pain management specialists. The Affordable Care Act (ACA) continuous to be amended by multiple administrative changes. This July 12th rule proposes substantial payment changes for evaluation and management (E&M) services, with documentation requirements, and blending of Level II to V CPT codes for E&M into a single payment. In addition, various changes in the quality payment program with liberalization of some metrics have been published. Recognizing that there are differing impacts based on specialty and practice type, as a whole interventional pain management specialists would likely see favorable reimbursement trends for E&M services as a result of this proposal. Moreover, in comparison with recent CMS final ruling, this proposed rule has relatively limited changes in procedural reimbursement performed in a facility or in-office setting. CMS, in the new rule, has proposed an overhaul of the E&M documentation and coding system ostensibly to reduce the amount of time physicians are required to spend inputting information into patients’ records. The new proposed rule blends Level II to V codes for E&M services into a single payment of $93 for office outpatient visits for established patients and $135 for new patient visits. This will also have an effect with blended payments for services provided in hospital outpatients. CMS also has provided additional codes to increase the reimbursement when prolonged services are provided with total reimbursement coming to Level V payments. Interventional pain managementcentered care has been identified as a specialty with complexity inherent to E&M associated with these services. Among the procedural payments, there exist significant discrepancies for the services performed in hospitals, ambulatory surgery centers (ASCs), and offices. A particularly egregious example is peripheral neurolytic blocks, which is reimbursed at 1,800% higher in hospital outpatient department (HOPD) settings as compared with procedures done in the office. The majority of hospital based procedures have faced relatively small cuts as compared with office based practice. The only significant change noted is for spinal cord stimulator implant leads when performed in office setting with 19.2% increase. However, epidural codes, which have been initiated with a lower payment, continue to face small reductions for physician portion. This review describes the effects of the proposed policy on interventional pain management reimbursement for E&M services, procedural services by physicians and procedures performed in office settings. Key words: Physician payment policy, physician fee schedule, Medicare, Merit-Based Incentive Payment System, interventional pain management, regulatory tsunami, Medicare Access and CHIP Reauthorization Act of 2015

Background Related to escalating health care costs and the questionable effectiveness of multiple interventions including lumbar facet joint interventions, cost effectiveness or cost utility analysis has become the cornerstone of evidence-based medicine influencing coverage decisions. Methods Cost utility of therapeutic lumbar facet joint nerve blocks in managing chronic low back pain was performed utilizing data from a randomized, double-blind, controlled trial with a 2-year follow-up, with direct payment data from 2016. Based on the data from surgical interventions, utilizing the lowest proportion of direct procedural costs of 60%, total cost utility per quality adjusted life year (QALY) was determined by multiplying the derived direct cost at 1.67. Results Patients in this trial on average received 5.6 ± 2.6 procedures over a period of 2 years, with average relief over a period of 2 years of 82.8 ± 29.6 weeks with 19 ± 18.77 weeks of improvement per procedure. Procedural cost for one-year improvement in quality of life showed USD $2,654.08. Estimated total costs, including indirect costs and drugs with multiplication of direct costs at 1.67, showed a cost of USD $4,432 per QALY. Conclusions The analysis of therapeutic lumbar facet joint nerve blocks in the treatment of chronic low back pain shows clinical effectiveness and cost utility at USD $2,654.08 for the direct costs of the procedures, and USD $4,432 for the estimated overall cost per one year of QALY, in chronic persistent low back pain non-responsive to conservative management.

Objective: To assess the prevalence of opioid-related deaths in patients in an interventional pain management tertiary referral center.Methods: Patient deaths from March 2003 to February 2007 were evaluated.Results: From March 2003 to February 2007, 2,179 patients were receiving opioids in 2003, 2,445 in 2004, 2,804 in 2005, and 2,965 in 2006, respectively. Overall, 86 percent of the patients were referred by a physician and 90 percent of patients received interventional techniques. There were a total of 91 deaths, of which 60 were categorized as natural deaths, 25 were characterized as accidental deaths, and 6 were characterized as suicidal. Of the 18 drug poisoning deaths, 5 deaths were positively related to prescription drugs, 7 deaths were probably related to prescription drugs, and 6 deaths had no relation to the prescription drugs provided. Total opioidrelated deaths were 12 over this 4-year period with 0.46 in 2003, 2.04 in 2004, 2.85 in 2005, and 1.35 in 2006 per 1,000 population. In contrast, deaths definitely related to prescription opioids were 5 (0.92 per 1,000) over a period of 4 years. In the suicidal group, there were a significantly higher proportion of patients with generalized anxiety disorder.Conclusions: In an interventional pain management practice (a tertiary referral center), the total prevalence of opioid-related deaths varied from 0.46 to 1.78 per 1,000 from 2003 to 2006 with a total of 12 deaths over a period of 4 years. The deaths definitely related to opioid prescriptions were 5 with a rate of 0 to 1.43 per 1,000 over a period of 4 years.

Background: Over the past 2 decades, the increase in the utilization of interventional techniques has been a cause for concern. Despite multiple regulations to reduce utilization of interventional techniques, growth patterns continued through 2009. A declining trend was observed in a previous evaluation; however, a comparative analysis of utilization patterns of interventional techniques has not been performed showing utilization before and after the enactment of the Affordable Care Act (ACA). Objectives: Our aim is to assess patterns of utilization and variables of interventional techniques in chronic pain management in the fee-for-service (FFS) Medicare population, with a comparative analysis of pre- and post-ACA. Study Design: Utilization patterns and variables of interventional techniques were assessed from 2000 to 2009 and from 2009 to 2016 in the FFS Medicare population of the United States in managing chronic pain. Methods: The master data from the Centers for Medicare & Medicaid Services (CMS) physician/ supplier procedure summary from 2000 to 2016 was utilized to assess overall utilization and comparative utilization at various time periods. Results: The analysis of Medicare data from 2000 to 2016 showed an overall decrease in utilization of interventional techniques 0.6% per year from 2009 to 2016, whereas from 2000 to 2009, there was an increase of 11.8% per year per 100,000 individuals of the Medicare population. In addition, the United States experienced an increase of 0.7% per year of population growth, 3.2% of those 65 years or older and a 3% annual increase in Medicare participation from 2009 to 2016. Further analysis also showed a 1.7% annual decrease in the rate of utilization of epidural and adhesiolysis procedures per 100,000 individuals of the Medicare population, with a 2.2% decrease for disc procedures and other types of nerve blocks, whereas there was an increase of 0.8% annually for facet joint interventions and sacroiliac joint blocks from 2009 to 2016. Epidural and adhesiolysis procedures showed an 8.9% annual increase, facet joint interventions and sacroiliac joint blocks showed a 17.6% increase, and disc procedures and other types of nerve blocks showed a 7.2% increase annually per 100,000 individuals of the Medicare population from 2000 to 2009. Limitations: The limitations of this assessment include lack of analysis of individual procedures. Additional limitations include lack of inclusion of patients from Medicare Advantage plans and lack of complete and accurate data for statewide utilization. Conclusion: From 2009 to 2016, interventional techniques decreased at an annual rate of 0.6% with an overall decrease of 3.9%, compared to an overall increase of 173.6% from 2000 to 2009 with an annual increase of 11.8%. An additional analysis of data with individual procedures is essential to gain further insights into utilization patterns. Key words: Interventional pain management, chronic spinal pain, interventional techniques, epidural injections, adhesiolysis, facet joint interventions, sacroiliac joint injections, disc procedures, other types of nerve blocks

Background: Controlled diagnostic studies have established the prevalence of cervical facet joint pain to range from 36% to 67% based on the criterion standard of ≥ 80% pain relief. Treatment of cervical facet joint pain has been described with Level II evidence of effectiveness for therapeutic facet joint nerve blocks and radiofrequency neurotomy and with no significant evidence for intraarticular injections. However, there have not been any cost effectiveness or cost utility analysis studies performed in managing chronic neck pain with or without headaches with cervical facet joint interventions. Study Design: Cost utility analysis based on the results of a double-blind, randomized, controlled trial of cervical therapeutic medial branch blocks in managing chronic neck pain. Objectives: To assess cost utility of therapeutic cervical medial branch blocks in managing chronic neck pain. Methods: A randomized trial was conducted in a specialty referral private practice interventional pain management center in the United States. This trial assessed the clinical effectiveness of therapeutic cervical medial branch blocks with or without steroids for an established diagnosis of cervical facet joint pain by means of controlled diagnostic blocks. Cost utility analysis was performed with direct payment data for the procedures for a total of 120 patients over a period of 2 years from this trial based on reimbursement rates of 2016. The payment data provided direct procedural costs without inclusion of drug treatments. An additional 40% was added to procedural costs with multiplication of a factor of 1.67 to provide estimated total costs including direct and indirect costs, based on highly regarded surgical literature. Outcome measures included significant improvement defined as at least a 50% improvement with reduction in pain and disability status with a combined 50% or more reduction in pain in Neck Disability Index (NDI) scores. Results: The results showed direct procedural costs per one-year improvement in quality adjusted life year (QALY) of United States Dollar (USD) of $2,552, and overall costs of USD $4,261. Overall, each patient on average received 5.7 ± 2.2 procedures over a period of 2 years. Average significant improvement per procedure was 15.6 ± 12.3 weeks and average significant improvement in 2 years per patient was 86.0 ± 24.6 weeks. Limitations: The limitations of this cost utility analysis are that data are based on a single center evaluation. Only costs of therapeutic interventional procedures and physician visits were included, with extrapolation of indirect costs. Conclusion: The cost utility analysis of therapeutic cervical medial branch blocks in the treatment of chronic neck pain non-responsive to conservative management demonstrated clinical effectiveness and cost utility at USD $4,261 per one year of QALY.

The cost of US health care continues to increase, with treatments related to low back and neck pain and other musculoskeletal disorders accounting for the third highest amount of various disease categories. Interventional techniques for managing pain apart from conservative modalities and surgical interventions, have generally been thought to be growing rapidly. However, a recent analysis of utilization of interventional techniques from 2000 to 2016 has shown a modest decline from 2009 to 2016, compared to 2000 to 2009.The objectives of this analysis include providing an update on utilization of interventional techniques in managing chronic pain in the Medicare population from 2009 to 2018 in the fee-for-service (FFS) Medicare population of the United States.Utilization patterns and variables of interventional techniques in managing chronic pain were assessed from 2000 to 2009 and from 2009 to 2018 in the FFS Medicare population of the United States.The data for the analysis was obtained from the master database from the Centers for MedicareMedicaid Services (CMS) physician/supplier procedure summary from 2000 to 2018. The analysis of data showed that there was a decline in utilization of interventional techniques from 2009 to 2018 of 6.7%, with an annual decline of 0.8% per 100,000 FFS Medicare population, despite an increase of 0.7% per year of population growth (3.2% of those 65 years or older) and a 3% annual increase in Medicare participation from 2009 to 2018. Medicare data from 2000 to 2009 showed an increase of 11.8% per year per 100,000 individuals of the Medicare population. The 2009 to 2018 data also showed a 2.6% annual decrease in the rate of utilization of epidural and adhesiolysis procedures per 100,000 population of FFS Medicare, and a 1% decrease for disc procedures and other types of nerve blocks, while there was an increase of 0.9% annually for facet joint interventions and sacroiliac joint blocks.Limitations of this analysis include: only the Medicare population was utilized, and among the Medicare population, only the FFS population was evaluated; utilization patterns in Medicare Advantage Plans, which constitutes almost 30% of the population were not considered. Further, the utilization data for individual states was sparse and may not be accurate.The decline in utilization of interventional techniques continued from 2009 to 2018 with 6.7% per 100,000 Medicare population, with an annual decline of 0.8%, despite an increase in the population rate and Medicare enrollees of 0.7% and 3% annually.Interventional pain management, chronic spinal pain, interventional techniques, epidural injections, adhesiolysis, facet joint interventions, sacroiliac joint injections, disc procedures, other types of nerve blocks.

Neck pain is one of the major conditions attributing to overall disability in the United States. There have been multiple publications assessing clinical and cost effectiveness of multiple modalities of interventions in managing chronic neck pain. Even then, the literature has been considered sparse in relation to cervical interlaminar epidural injections in managing chronic neck pain. In contrast, cost utility studies of lumbar interlaminar injections, caudal epidural injections, cervical and lumbar facet joint nerve blocks, percutaneous adhesiolysis demonstrated costs of less than $3,500 for quality-adjusted life year (QALY).To assess the cost utility of cervical interlaminar epidural injections in managing chronic neck and/or upper extremity pain secondary to cervical disc herniation, post-surgery syndrome in neck, and axial or discogenic neck pain.Analysis based on 3 previously published randomized trials of the effectiveness of cervical interlaminar epidural injections assessing their role in disc herniation, cervical post-surgery syndrome, and axial or discogenic pain.A contemporary, private, specialty referral interventional pain management center in the United States.Cost utility of cervical interlaminar epidural injections with or without steroids in managing cervical disc herniation, cervical post-surgery syndrome, and cervical discogenic or axial neck back pain was conducted with data derived from 3 randomized controlled trials (RCTs) that included a 2-year follow-up, with inclusion of 356 patients. The primary outcome was significant improvement defined as at least 50% in pain reduction and disability status. Direct payment data from all carriers from 2018 was utilized for the assessment of procedural costs. Overall costs, including drug costs, were determined by multiplication of direct procedural payment data by a factor of 1.67 to accommodate for indirect payments respectively for disc herniation, discogenic pain, and cervical post-surgery syndrome.The results of the 3 RCTs showed direct cost utility for one year of QALY of $2,412.31 for axial or discogenic pain without disc herniation, $2,081.07 for disc herniation, and $2,309.20 for post surgery syndrome, with an average cost per one year QALY of $2,267.57, with total estimated overall costs with addition of indirect costs of $3,475.38, $4,028.55, $3,856.36, and $3,785.89 respectively.The limitation of this cost utility analysis includes that it is a single center evaluation. Indirect costs were extrapolated.This cost utility analysis of cervical interlaminar epidural injections in patients nonresponsive to conservative management in the treatment of disc herniation, post surgery syndrome and axial or discogenic neck pain shows $2,267.57 for direct costs with a total cost of $3,785.89 per QALY.Cervical interlaminar epidural injections, chronic neck pain, cervical disc herniation, cervical discogenic pain, post surgery syndrome, cost utility analysis, cost effectiveness analysis, quality-adjusted life years.

To assess patterns of utilization and variables of facet joint interventions in managing chronic spinal pain in a fee-for-service (FFS) Medicare population from 2009 to 2016, with a comparative analysis from 2000 to 2009 and 2009 to 2016. From 2009 to 2016, facet joint interventions increased at an annual rate of 2% per 100,000 Medicare population compared to 10.2% annual rate of increase from 2000 to 2009. Lumbosacral facet joint nerve block episodes decreased at an annual rate of 0.1% from 2009 to 2016, with an increase of 16.2% from 2000 to 2009. In contrast, lumbosacral facet joint neurolysis episodes increased at an annual rate of 7.6% from 2009 to 2016 and the utilization rate also increased at an annual rate of 26% from 2000 to 2009. The ratio of lumbar facet joint block episodes to lumbosacral facet joint neurolysis episodes changed from 6.7 in 2000 to 2.2 in 2016. From 2009 to 2016, cervical and thoracic facet joint injections increased at an annual rate of 0.6% compared to cervicothoracic facet neurolysis episodes of 9.2%. During 2000 to 2009, annual increase of cervical facet joint injections was 18% compared to neurolysis procedures of 26%. The ratio of cervical facet joint injections episodes to neurolysis episodes changed from 8.85 in 2000 to 2.8 in 2016. In summary, based on available data, utilization patterns of facet joint interventions demonstrated an increase of 2% per 100,000 Medicare population from 2009 to 2016, with an annual decline of lumbar facet joint injection episodes.

Several cell-based therapies have been proposed in recent years the management of low back pain, including the injection of medicinal signaling cells or mesenchymal stem cells (MSCs) and platelet-rich plasma (PRP). However, there is only emerging clinical evidence to support their use at this time.To assess the effectiveness of MSCs or PRP injections in the treatment of low back and lower extremity pain.A systematic review and metaanalysis of the effectiveness of PRP and MSCs injections in managing low back and lower extremity pain.PubMed, Cochrane Library, US National Guideline Clearinghouse, prior systematic reviews, and reference lists. The literature search was performed from 1966 through June 2018.Randomized trials, observational studies, and case reports of injections of biologics into the disc, epidural space, facet joints, or sacroiliac joints.Data extraction and methodological quality assessment were performed utilizing Cochrane review methodologic quality assessment and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR). The evidence was summarized utilizing principles of best evidence synthesis on a scale of 1 to 5.Twenty-one injection studies met inclusion criteria. There were 12 lumbar disc injections, 5 epidural, 3 lumbar facet joint, and 3 sacroiliac joint studies RESULTS: Evidence synthesis based on a single-arm metaanalysis, randomized controlled trials (RCTs), and observational studies, disc injections of PRP and MSCs showed Level 3 evidence (on a scale of Level I through V). Evidence for epidural injections based on single-arm metaanalysis, a single randomized controlled trial and other available studies demonstrated Level 4 (on a scale of Level I through V) evidence. Similarly, evidence for lumbar facet joint injections and sacroiliac joint injections without metaanalysis demonstrated Level 4 evidence (on a scale of Level I through V).Lack of high quality RCTs.The findings of this systematic review and single-arm metaanalysis shows that MSCs and PRP may be effective in managing discogenic low back pain, radicular pain, facet joint pain, and sacroiliac joint pain, with variable levels of evidence in favor of these techniques.Chronic low back pain, regenerative therapy, medicinal signaling or mesenchymal stem cells, platelet-rich plasma, disc injection, lumbar facet joint injections, sacroiliac joint injections.

On July 12, 2018, the Centers for Medicare and Medicaid Services (CMS) released the proposed 2019 Medicare physician fee schedule and quality payment program, combining these 2 rules for the first time. This occurred in a milieu of changing regulations that have been challenging for interventional pain management specialists. The Affordable Care Act (ACA) continuous to be amended by multiple administrative changes. This July 12th rule proposes substantial payment changes for evaluation and management (EM) services, with documentation requirements, and blending of Level II to V CPT codes for EM into a single payment. In addition, various changes in the quality payment program with liberalization of some metrics have been published. Recognizing that there are differing impacts based on specialty and practice type, as a whole interventional pain management specialists would likely see favorable reimbursement trends for EM services as a result of this proposal. Moreover, in comparison with recent CMS final ruling, this proposed rule has relatively limited changes in procedural reimbursement performed in a facility or in-office setting.CMS, in the new rule, has proposed an overhaul of the EM documentation and coding system ostensibly to reduce the amount of time physicians are required to spend inputting information into patients' records. The new proposed rule blends Level II to V codes for EM services into a single payment of $93 for office outpatient visits for established patients and $135 for new patient visits. This will also have an effect with blended payments for services provided in hospital outpatients. CMS also has provided additional codes to increase the reimbursement when prolonged services are provided with total reimbursement coming to Level V payments. Interventional pain management-centered care has been identified as a specialty with complexity inherent to EM associated with these services. Among the procedural payments, there exist significant discrepancies for the services performed in hospitals, ambulatory surgery centers (ASCs), and offices. A particularly egregious example is peripheral neurolytic blocks, which is reimbursed at 1,800% higher in hospital outpatient department (HOPD) settings as compared with procedures done in the office. The majority of hospital based procedures have faced relatively small cuts as compared with office based practice. The only significant change noted is for spinal cord stimulator implant leads when performed in office setting with 19.2% increase. However, epidural codes, which have been initiated with a lower payment, continue to face small reductions for physician portion.This review describes the effects of the proposed policy on interventional pain management reimbursement for EM services, procedural services by physicians and procedures performed in office settings.Physician payment policy, physician fee schedule, Medicare, Merit-Based Incentive Payment System, interventional pain management, regulatory tsunami, Medicare Access and CHIP Reauthorization Act of 2015.

A retrospective cohort study of utilization patterns of epidural injections.The aim of this study was to assess patterns of utilization and variables of in chronic spinal pain in the fee-for-service (FFS) Medicare population, with a comparative analysis of pre- and post-Affordable Care Act (ACA) data from 2000 to 2009 and 2009 to 2016.Over the years, utilization of interventional pain management techniques, specifically epidural injections have increased creating concern over costs and public health policy.The master data from the Centers for MedicareMedicaid Services (CMS) physician/supplier procedure summary from 2000 to 2016 was utilized to assess utilization patterns. The descriptive analysis of the database analysis was performed using guidance from the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). Multiple variables were analyzed based on the procedures, specialties, and geography.Caudal and lumbar interlaminar epidural injections decreased 25% from 2009 to 2016 with an annual decrease of 4% in contrast to lumbosacral transforaminal epidural injection episodes, increasing at an annual rate of 0.3%. In contrast, lumbar interlaminar epidural injections increased 2.4% annually, while transforaminal episodes increased 23% from 2000 to 2009. The ratio of interlaminar epidural injections to transforaminal epidural injection episodes has changed from 7 in 2000 to 1 in 2016, whereas ratio of services changed from 5 to 0.7. From 2009 to 2016, cervical/thoracic interlaminar epidural injections episodes increased at an annual rate of 0.5%, with a decrease of 2.3% for transforaminal epidural injections.Comparative analysis of the utilization of epidural injections from 2000 to 2009 and 2009 to 2016 showed vast differences with overall significant decreases in utilization, specifically for lumbar interlaminar and caudal epidural injections, with a continued, though greatly slowed increase of lumbosacral transforaminal epidural injections.3.

Background: The rapid increase in the prevalence of chronic pain and disability, and the explosion of interventional pain management associated health care costs are a major concern for our community. Further, the increasing utilization of numerous modalities of treatments in managing chronic pain, continue to escalate at a pace which may not be sustainable. There are multiple regulations in place to control the growth of health care expenditures which seem to have been largely ineffective. Among the various modalities utilized in managing chronic pain, interventional techniques have shown a significant increase in their utilization in the face of continued debate with respect to the accuracy of diagnostic interventions and the efficacy of therapeutic interventions. Objective: To update and assess the utilization of interventional techniques in chronic pain management in fee-for-service Medicare population. Study Design: An updated analysis of the growth of interventional techniques in managing chronic pain in fee-for-service Medicare beneficiaries from 2000 through 2013. Methods: The data were derived and analyzed utilizing the Centers for Medicare and Medicaid Services (CMS) Physician Supplier Procedure Summary Master Data from 2000 through 2013. Results: From 2000 through 2013, in fee-for-service Medicare beneficiaries, the overall utilization of interventional techniques services increased 236% at an annual average growth of 9.8%, whereas the per 100,000 Medicare population utilization increased 156% with an annual average growth of 7.5%. During this period, the US population increased 12% with an annual average increase of 0.9%, whereas those above 65 years of age increased 27% with an annual average increase of 1.9%. Total Medicare beneficiaries increased 31% with an annual average increase of 2.1%, with an overall increase of 64% for those above 65 years of age, an increase of 26%, constituting 17% of the US population in 2013. The overall increases in epidural and adhesiolysis procedures were 165% compared to 102% per 100,000 fee-for-service population with annual average increases of 7.8% and 5.6%. Facet joint and sacroiliac joint injections increased 417% for services with an annual average increase of 13.5%, whereas the rate per 100,000 fee-for-service Medicare beneficiaries increased 295% with an annual average increase of 11.1%. Limitations: Limitations of this assessment include the lack of inclusion of participants from Medicare Advantage plans, lack of appropriate available data for state-wide utilization, and potential errors in documentation, coding, and billing. Conclusion: This update once again shows a significant increase in interventional techniques in feefor-service Medicare beneficiaries from 2000 through 2013 with an increase of 156% per 100,000 Medicare population with an annual average increase of 7.5%. During this period the Medicare population increased 31% with an annual average increase of 2.1%. Key words: Chronic pain, chronic spinal pain, interventional pain management, interventional techniques, epidural injections, facet joint interventions, sacroiliac joint injections

Background: Epidural injections are performed utilizing 3 approaches in the lumbar spine: caudal, interlaminar, and transforaminal. The literature on the efficacy of epidural injections has been sporadic. There are few high-quality randomized trials performed under fluoroscopy in managing disc herniation that have a long-term follow-up and appropriate outcome parameters. There is also a lack of literature comparing the efficacy of these 3 approaches. Methods: This manuscript analyzes data from 3 randomized controlled trials that assessed a total of 360 patients with lumbar disc herniation. There were 120 patients per trial either receiving local anesthetic alone (60 patients) or local anesthetic with steroids (60 patients). Results: Analysis showed similar efficacy for caudal, interlaminar, and transforaminal approaches in managing chronic pain and disability from disc herniation. The analysis of caudal epidural injections showed the potential superiority of steroids compared with local anesthetic alone a 2-year follow-up, based on the average relief per procedure. In the interlaminar group, results were somewhat superior for pain relief in the steroid group at 6 months and functional status at 12 months. Interlaminar epidurals provided improvement in a significantly higher proportion of patients. The proportion of patients nonresponsive to initial injections was also lower in the group for local anesthetic with steroid in the interlaminar trial. Conclusions: The results of this assessment show significant improvement in patients suffering from chronic lumbar disc herniation with 3 lumbar epidural approaches with local anesthetic alone, or using steroids with long-term follow-up of up to 2 years, in a contemporary interventional pain management setting. (Korean J Pain 2015; 28: 11-21)

Background: While low back pain is the number one cause of disability in the United States, lumbar spinal stenosis along with intervertebral disc herniation and degenerative spondylolisthesis is one of the 3 most common diagnosis of low back and leg pain for which surgery is performed. Numerous modalities of treatments including drug therapy and complex surgical fusions have been recommended for treatment of central spinal stenosis. Epidural injections are one of the commonly performed nonsurgical interventions in managing central spinal stenosis; however, there has been paucity of literature in reference to efficacy of epidural injections in managing central spinal stenosis with lumbar interlaminar epidural injections. Study Design: A randomized, double-blind, active controlled trial. Setting: Private interventional pain management practice and specialty referral center in the United States. Objective: To assess the effectiveness of lumbar interlaminar epidural injections with or without steroids in providing effective and long-lasting pain relief with improvement in functional status for the management of chronic low back and lower extremity pain related to lumbar central spinal stenosis. Methods: A randomized, double-blind, active-control trial was designed with the inclusion of 120 patients assigned to 2 groups. Group I patients received lumbar interlaminar epidural injections of local anesthetic (lidocaine 0.5%) 6 mL, whereas Group II received lumbar interlaminar epidural injections with local anesthetic (lidocaine 0.5%) 5 mL mixed with 1 mL of steroids and 6 mg of betamethasone. Outcomes Assessment: Outcomes were assessed utilizing the numeric pain rating scale (NRS) and Oswestry Disability Index (ODI) at 3, 6, 12, 18, and 24 months post treatment. The primary outcome measure was significant improvement, defined as 50% improvement in pain and disability scores. Results: Significant relief and functional status improvement was seen in 72% and 73% of patients in Groups I and II at the end of 2 years considering all participants; however, this was 84% and 85% in the successful group. Overall significant improvement was achieved for 65.7 ± 37.3 weeks in Group 1 and 68.9 ± 37.7 weeks in Group II at the end of 2 years when all participants were considered; whereas, this was 77 ± 27.8 weeks and 77.9 ± 30.2 weeks when they were separated into successful categories. The average number of procedures per patient was 5 to 6 in both groups. Limitations: Limitations of this trial include lack of placebo control group and treatment of patients with multiple procedures over a period of 2 years. Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or without steroids provide relief in a significant proportion of patients with lumbar central spinal stenosis. Key words: Chronic low back pain, lower extremity pain, central spinal stenosis, interlaminar epidural injections, caudal epidural injections, steroids, local anesthetics, placebo, active control

Study Design: Comparative assessment of randomized controlled trials of caudal and lumbar interlaminar epidural injections in chronic lumbar discogenic pain. Objective: To assess the comparative efficacy of caudal and lumbar interlaminar approaches of epidural injections in managing axial or discogenic low back pain. Summary of Background Data: Epidural injections are commonly performed utilizing either a caudal or lumbar interlaminar approach to treat chronic lumbar axial or discogenic pain, which is pain exclusive of that associated with a herniated intervertebral disc, or that is due to degeneration of the zygapophyseal joints, or due to dysfunction of the sacroiliac joints, respectively. The literature on the efficacy of epidural injections in managing chronic axial lumbar pain of presumed discogenic origin is limited. Methods: The present analysis is based on 2 randomized controlled trials of chronic axial low back pain not caused by disc herniation, radiculitis, or facet joint pain, utilizing either a caudal or lumbar interlaminar approach, with a total of 240 patients studied, and a 24-month follow-up. Patients were assigned to receive either local anesthetic only or local anesthetic with a steroid in each 60 patient group. Results: The primary outcome measure was significant improvement, defined as pain relief and functional status improvement of at least 50% from baseline, which was reported at 24-month follow-ups in 72% who received local anesthetic only with a lumbar interlaminar approach and 54% who received local anesthetic only with a caudal approach. In patients receiving local anesthetic with a steroid, the response rate was 67% for those who had a lumbar interlaminar approach and 68% for those who had a caudal approach at 12 months. The response was significantly better in the lumbar interlaminar group who received local anesthetic only, 77% versus 56% at 12 months and 72% versus 54% at 24 months. Conclusion: This assessment shows that in patients with axial or discogenic pain in the lumbar spine after excluding facet joint and SI Joint pain, epidural injections of local anesthetic by the caudal or lumbar interlaminar approach may be effective in managing chronic low back pain with a potential superiority for a lumbar interlaminar approach over a caudal approach.

Cost utility or cost effective analysis continues to take center stage in the United States for defining and measuring the value of treatments in interventional pain management. Appropriate cost utility analysis has been performed for caudal epidural injections, percutaneous adhesiolysis, and spinal cord stimulation. However, the literature pertaining to lumbar interlaminar epidural injections is lacking, specifically in reference to cost utility analysis derived from randomized controlled trials (RCTs) with a pragmatic approach in a practical setting.To assess the cost utility of lumbar interlaminar epidural injections in managing chronic low back and/or lower extremity pain secondary to lumbar disc herniation, spinal stenosis, and axial or discogenic low back pain.Analysis based on 3 previously published randomized trials of effectiveness of lumbar interlaminar epidural injections assessing their role in disc herniation, spinal stenosis, and axial or discogenic pain.A contemporary, private, specialty referral interventional pain management center in the United States.Cost utility of lumbar interlaminar epidural injections with or without steroids in managing lumbar disc herniation, central spinal stenosis, and discogenic or axial low back pain was conducted with data derived from 3 RCTs that included a 2-year follow-up, with inclusion of 360 patients. The primary outcome was significant improvement defined as at least a 50% in pain reduction and disability status. Direct payment data from 2016 was utilized for assessment of procedural costs. Overall costs, including drug costs, were determined by multiplication of direct procedural payment data by a factor of 1.6 to accommodate for indirect payments respectively for disc herniation, spinal stenosis, discogenic pain.The results of 3 RCTs showed direct cost utility for one year of quality-adjusted life year (QALY) of $2,050.87 for disc herniation, $2,112.25 for axial or discogenic pain without disc herniation, and $1,773.28 for spinal stenosis, with an average cost per one year QALY of $1,976.58, with total estimated costs of $3,425, $3,527, $2,961, and $3,301 respectively.The limitation of this cost utility analysis includes that it is a single center evaluation, even though 360 patients were included in this analysis. Further, only the costs of interventional procedures and physician visits were assessed based on the data, with extrapolation of indirect costs presenting the overall total costs. The benefits of returning to work were not assessed.This cost utility analysis of lumbar interlaminar epidural injections in patients nonresponsive to conservative management in the treatment of disc herniation, central spinal stenosis, and axial or discogenic low back pain in the lumbar spine shows the clinical effectiveness and cost utility of these injections of $1,976.58 for direct costs with a total cost of $3,301 per QALY.

Background: Reports of prevalence of spinal pain indicate the prevalence of thoracic pain in approximately 13% of the general population compared to 32% of the population with neck pain and 43% of the population with low back pain during the past year. Even though, thoracic pain is less common than neck or low back pain, the degree of disability resulting from thoracic pain disorders seems to be similar to other painful conditions. Interventions in managing chronic thoracic pain are also less frequent, leading to the paucity of literature about various interventions in managing chronic thoracic pain. Thoracic intervertebral discs and thoracic facet joints have been shown to be pain generators, even though thoracic radicular pain is very infrequent. Thoracic epidural injections are one of the commonly performed procedures in managing thoracic pain. The efficacy of thoracic epidural injections has not been well studied. Study Design: A randomized, double-blind, active controlled trial. Setting: Private interventional pain management practice and specialty referral center in the United States. Objective: The primary objective was to assess the effectiveness of thoracic interlaminar epidural injections in providing effective pain relief and improving function in patients with chronic mid and/ or upper back pain. Methods: One hundred and ten patients were randomly assigned into 2 groups with 55 patients in each group receiving either local anesthetic alone (Group I) or local anesthetic with steroids (Group II). Randomization was performed by computer-generated random allocation sequence by simple randomization. Outcomes Assessment: Outcomes were assessed utilizing Numeric Rating Scale (NRS), the Oswestry Disability Index (ODI) 2.0, employment status, and opioid intake. The patients experiencing greater than 3 weeks of significant improvement with the first 2 procedures were considered as successful. Others were considered as failed participants. Significant improvement was defined as a decrease of greater than 50% NRS scores and ODI scores with measurements performed at baseline, 3, 6, 12, 18, and 24 months post treatment. Results: Significant improvement was seen in 71% in Group I and 80% in Group II at the end of 2 years with all participants; however, improvement was seen in 80% and 86% when only successful patients were considered. Therapeutic procedural characteristics showed 5 to 6 procedures per 2 years with total average relief of 80 weeks in Group I and 78 weeks in Group II in the successful patient category; whereas, it was 71 and 72 weeks when all patients were considered. Limitations: Limitations of this assessment include lack of a placebo group.Conclusions: Based on the results of this trial, it is concluded that chronic thoracic pain of non-facet joint origin may be managed conservatively with thoracic interlaminar epidural injections with or without steroids. Key words: Chronic thoracic pain, chest wall pain, disc herniation, discogenic pain, radiculitis, thoracic interlaminar epidural injections, steroids, local anesthetic