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To create a successful ambulatory care center, healthcare systems need management that can understand and improve key ambulatory success factors such as quality of clinical care, clinical competence, regulatory compliance, financial management, and customer service. Effective leadership is a vital skill that can improve all these factors. This manuscript discusses successful perioperative leadership styles in the ambulatory setting and provides a framework for proven strategies that have improved patient care.

The main objective of this review is to appraise the literature on the role of spinal cord stimulation (SCS), cannabinoid therapy, as well as SCS and cannabinoid combination therapy for the management of chronic neuropathic and nociceptive pain. Current research suggests that SCS reduces pain and increases functional status in carefully selected patients with minimal side effects.As cannabinoid-based medications become a topic of increasing interest in pain management, data remains limited regarding the clinical efficacy of cannabinoids for pain relief. Furthermore, from a mechanistic perspective, although various pain treatment modalities utilize overlapping pain-signaling pathways, clarifying whether cannabinoids work synergistically with SCS via shared mechanisms remains to be determined. In considering secondary outcomes, the current literature suggests cannabinoids improve quality of life, specifically sleep quality, and that SCS decreases opioid consumption, increases functional capacity, and decreases long-term healthcare costs. These findings, along with the high safety profiles of SCS and cannabinoids overall, incentivize further exploration of cannabinoids as an adjunctive therapy to SCS in the treatment of neuropathic and nociceptive pain.

Coronavirus disease (COVID-19) causes many deleterious effects throughout the body. Prior studies show that the incidence of acute kidney injury in COVID-19 patients could be as high as 25%. There are also autopsy reports showing evidence of viral tropism to the renal system. In this regard, COVID-19 can damage the kidneys and increase a patient's risk of requiring dialysis. Available evidence suggests that renal involvement in COVID-19 infection is not uncommon, and there has been an increased incidence of chronic kidney disease related to the pandemic. In this literature analysis, we address COVID-19 and its effects on the renal system, including the pathophysiologic mechanisms. We also address current studies on the causes of injury to the renal system, the cause of kidney failure, its effect on mortality, the impact on dialysis patients, and the impact on renal transplant patients. COVID-19 disease may have unique features in individuals on chronic dialysis and kidney transplant recipients, requiring increased vigilance in limiting viral transmission in perioperative, in-patient, and dialysis center settings.

The Hospital Incident Command System (HICS) is an incident management system specific to hospitals based on the principles of Incident Command System (ICS), and it includes prevention, protection, mitigation, response, and recovery. It plays a crucial role in effective and timely response during the periods of disasters, mass casualties, and public health emergencies. In recent times, hospitals have used a customized HICS structure to coordinate effective responses to public health problems such as the Ebola outbreak in the US and SARS epidemic in Taiwan. The current COVID-19 pandemic has placed unprecedented challenges on the healthcare system, necessitating the creation of HICS that can help in the proper allocation of resources and ineffective utilization of healthcare personnel. The key elements in managing a response to this pandemic include screening and early diagnosis, quarantining affected individuals, monitoring disease progression, delivering appropriate treatment, and ensuring an adequate supply of personal protective equipment (PPE) to healthcare staff.

Chronic pain is a common source of morbidity in many patient populations worldwide. There are growing concerns about the potential side effects of currently prescribed medications and a continued need for effective treatment. Related to these concerns, peripheral nerve stimulation has been regaining popularity as a potential treatment modality. Peripheral nerve stimulation components include helically coiled electrical leads, which direct an applied current to afferent neurons providing sensory innervation to the painful area. In theory, the applied current to the peripheral nerve will alter the large-diameter myelinated afferent nerve fibers, which interfere with the central processing of pain signals through small-diameter afferent fibers at the level of the spinal cord. Multiple studies have shown success in the use of peripheral nerve stimulation for acute post-surgical pain for orthopedic surgery, including post total knee arthroplasty and anterior cruciate ligament surgery, and chronic knee pain. Many studies have investigated the utility of peripheral nerve stimulation for the management of chronic shoulder pain. Peripheral nerve stimulation also serves as one of the potential non-pharmacologic therapies to treat back pain along with physical therapy, application of transcutaneous electrical neurostimulation unit, radiofrequency ablation, epidural steroid injections, permanently implanted neurostimulators, and surgery. Studies regarding back pain treatment have shown that peripheral nerve stimulation led to significant improvement in all pain and quality-of-life measures and a reduction in the use of opioids. Further studies are needed as the long-term risks and benefits of peripheral nerve stimulation have not been well studied as most information available on the effectiveness of peripheral nerve stimulation is based on shorter-term improvements in chronic pain.

Painful diabetic neuropathy is a common disease that results in significant pain and disability. Treatment options have traditionally consisted of conservative measures including topical and oral medication management as well as transcutaneous electrical stimulation units. These treatments demonstrate various degrees of efficacy, and many times initial treatments are discontinued, indicating low levels of satisfaction or poor tolerability. Spinal cord stimulation has been proposed as an alternative therapy for treatment of painful diabetic neuropathy of the lower extremities. We performed a systematic literature review to evaluate the safety and effectiveness of this procedure. A literature search identified 14 prospective studies. Based on our analysis of the available evidence, there is moderate-quality evidence for the safety and efficacy of spinal cord stimulation for painful diabetic neuropathy. However, further high-quality research, including a large-scale randomized controlled trial is warranted. Supplementary Information The online version contains supplementary material available at 10.1007/s40122-021-00282-9.

Background Recalcitrant disc herniation may result in chronic lumbar radiculopathy or sciatica. Fluoroscopically directed epidural injections and other conservative modalities may provide inadequate improvement in some patients. In these cases, percutaneous neurolysis with targeted delivery of medications is often the next step in pain management. Methods An evidence-based system of methodologic assessment, namely, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was used. Multiple databases were searched from 1966 to January 2021. Principles of the best evidence synthesis were incorporated into qualitative evidence synthesis. The primary outcome measure was the proportion of patients with significant pain relief and functional improvement (≥ 50%). Duration of relief was categorized as short-term (< 6 months) and long-term (≥ 6 months). Results This assessment identified one high-quality randomized controlled trial (RCT) and 5 moderate-quality non-randomized studies with an application of percutaneous neurolysis in disc herniation. Overall, the results were positive, with level II evidence. Conclusions Based on the present systematic review, with one RCT and 5 non-randomized studies, the evidence level is II for percutaneous neurolysis in managing lumbar disc herniation.

Extensive research into potential sources of neck pain and referred pain into the upper extremities and head has shown that the cervical facet joints can be a potential pain source confirmed by precision, diagnostic blocks.Systematic review and meta-analysis utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist, quality assessment of the included studies, conventional and single-arm meta-analysis, and best evidence synthesis.The objective of this systematic review and meta-analysis is to evaluate the effectiveness of radiofrequency neurotomy as a therapeutic cervical facet joint intervention in managing chronic neck pain.Available literature was included. Methodologic quality assessment of studies was performed from 1996 to September 2021. The level of evidence of effectiveness was determined.Based on the qualitative and quantitative analysis with single-arm meta-analysis and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system of appraisal, with inclusion of one randomized controlled trial (RCT) of 12 patients in the treatment group and eight positive observational studies with inclusion of 589 patients showing positive outcomes with moderate to high clinical applicability, the evidence is level II in managing neck pain with cervical radiofrequency neurotomy. The evidence for managing cervicogenic headache was level III to IV with qualitative analysis and single-arm meta-analysis and GRADE system of appraisal, with the inclusion of 15 patients in the treatment group in a positive RCT and 134 patients in observational studies. An overwhelming majority of the studies produced multiple lesions.There was a paucity of literature and heterogeneity among the available studies.This systematic review and meta-analysis shows level II evidence with radiofrequency neurotomy on a long-term basis in managing chronic neck pain with level III to IV evidence in managing cervicogenic headaches.The online version contains supplementary material available at 10.1007/s40122-022-00455-0.

Context: Robotic surgery is becoming the most common approach in minimally invasive urologic procedures. Robotic surgery offers less pain to patients because of smaller keyhole incisions and less tissue retraction and stretching of fascia and muscular fibers. Tailored pain regimens have also evolved and allowed patients to feel minimal to no discomfort after robotic urologic surgery, allowing in parallel better surgical outcomes. This study aims to analyze the most current pain regimens in robotic urologic surgery and to evaluate the most current pain protocols and corresponding outcomes. Evidence Acquisition: A literature review was performed of published manuscripts utilizing Pubmed and Google Scholar on pain protocols for patients undergoing robotic urologic surgery. Results: Multimodal analgesia is gaining ground in robotic urologic surgery. Regional analgesia includes four major modalities: Neuroaxial analgesia, intercostal blocks, tranvsersus abdominis plane blocks, and paravertebral blocks. Each approach has a different injection site, region of analgesia coverage, and duration of coverage depending upon local anesthesia and/or adjuvant utilized with advantages and disadvantages that make each modality unique and efficacious. Conclusions: Robotic urologic surgery has offered the advantage of smaller incisions, faster recovery, less postoperative opioid consumption, and better surgical outcomes. Neuraxial, intercostal, transversus abdominis plane, and quadratus lumborum blocks are the best and most adopted approaches which offer optimal outcomes to patients.

A large portion of US healthcare is ambulatory. Strong leadership is vital for the safety and efficiency of perioperative patients in this setting. Good leaders communicate respectfully and openly and ensure effective systems in the delivery of high-level healthcare. In general, to promote patient safety and treatment efficacy, ambulatory care leaders must improve communication. Effective administration is unattainable without leadership and communication in an operating room. When considering outpatient perioperative therapy, it is equally crucial to consider medical costs. Given the unsustainable rate of healthcare spending growth, all attempts to improve our present systems are necessary. Ambulatory care facilities must utilize data regarding resource consumption to be financially viable related to escalating expenses. The present review describes perioperative and financial leadership in the ambulatory setting, effective systems, and relevant clinical strategies.

Introduction The multifaceted clinical presentation of fibromyalgia (FM) supports the modern understanding of the disorder as a more global condition than one simply affecting pain sensation. The main pharmacologic therapies used clinically include anti-epileptics and anti-depressants. Conservative treatment options include exercise, myofascial release, psychotherapy, and nutrient supplementation. Methods Narrative review. Results Nutrient supplementation is a broadly investigated treatment modality as numerous deficiencies have been linked to FM. Additionally, a proposed link between gut microbiome patterns and chronic pain syndromes has led to studies investigating probiotics as a possible treatment. Despite positive results, much of the current evidence regarding this topic is of poor quality, with variable study designs, limited sample sizes, and lack of control groups. Conclusions The etiology of FM is complex, and has shown to be multi-factorial with genetics and environmental exposures lending influence into its development. Preliminary results are promising, however, much of the existing evidence regarding diet supplementation is of poor quality. Further, more robust studies are needed to fully elucidate the potential of this alternative therapeutic option.

The COVID-19 pandemic has affected the entire world and catapulted the United States into one of the deepest recessions in history. While this pandemic rages, the opioid crisis worsens. During this period, the pandemic has resulted in the decimation of most conventional medical services, including those of chronic pain management, with the exception of virtual care and telehealth. Many chronic pain patients have been impacted in numerous ways, with increases in cardiovascular disease, mental health problems, cognitive dysfunction, and early death. The epidemic has also resulted in severe economic and physiological consequences for providers. Drug deaths in America, which fell for the first time in 25 years in 2018, rose to record numbers in 2019 and are continuing to climb, worsened by the coronavirus pandemic. The opioid epidemic was already resurfacing with a 5% increase in overall deaths from 2018; however, the preliminary data show that prescription opioid deaths continued to decline, while at the same time deaths due to fentanyl, methamphetamine, and cocaine climbed, with some reductions in heroin deaths. The health tracker data also showed that along with an almost 88% decline in elective surgeries, pain-related prescriptions declined 15.1%. Despite increases in telehealth, outpatient services declined and only began returning towards normal at an extremely slow pace, accompanied by reduced productivity and increased practice costs. This review, therefore, emphasizes the devastating consequences of concurrent epidemics on chronic pain management and the need to develop best practice efforts to preserve access to treatment for chronic pain.

Objective: The present investigation aims to identify characteristics associated with heroin use among those reporting prescription opioid misuse from a nationally representative sample, and how these characteristics vary by urbanicity. Design: A cross-sectional analysis.Setting: Pooled 2015-2018 data from the National Survey on Drug Use and Health (NSDUH), the leading source for nationally representative substance use, mental health, and other health-related data and trends in the United States.Patients and participants: 23,719 participants (12,109 male and 11,610 female) reporting previous prescription opioid misuse in the 2015-2018 NSDUH data. Interventions: None.Main outcome measures: Univariable and multivariable logistic regressions were used to assess the association of characteristics with heroin use, stratified by urbanicity.Results: After multivariable adjustment, factors associated with heroin use among prescription opioid misusers were male sex, non-Hispanic White race, low educational attainment, recent nonopioid illicit drug use, and recent nonopioid prescription drug misuse. Commercial health insurance was associated with lower odds of heroin use among both rural and urban prescription opioid misusers, but an observed association between Medicaid and greater odds of heroin use was stronger among urban versus rural participants. In contrast, observed associations between illicit drug use other than marijuana in the past year and greater odds of heroin use were stronger among rural vs urban participants.Conclusion: Important differences exist between factors associated with heroin use among urban and rural prescription opioid misusers, and there is a need to consider broader polysubstance use trends and barriers to mental healthcare access to adequately address heroin use.

Hospitals face catastrophic financial challenges in light of the coronavirus disease 2019 (COVID-19) pandemic. Acute shortages in materials such as masks, ventilators, intensive care unit capacity, and personal protective equipment (PPE) are a significant concern. The future success of supply chain management involves increasing the transparency of where our raw materials are sourced, diversifying of our product resources, and improving our technology that is able to predict potential shortages. It is also important to develop a proactive budgeting strategy to meet supply demands through early designation of dependable roles to support organizations and through the education of healthcare staff. In this paper, we discuss supply chain management, governance and financing, emergency protocols, including emergency procurement and supply chain, supply chain gaps and how to address them, and the importance of communication in the times of crisis.

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

Chronic pain syndromes cost the US healthcare system over $600 billion per year. A subtype of chronic pain is neuropathic pain (NP), which is defined as "pain caused by a lesion or disease of the somatosensory system," according to the International Association for the Study of Pain (IASP). The pathophysiology of neuropathic pain is very complex, and more research needs to be done to find the exact mechanism. Patients that have preexisting conditions such as cancer and diabetes are at high-risk of developing NP. Many NP patients are misdiagnosed and receive delayed treatment due to a lack of a standardized classification system that allows clinicians to identify, understand, and utilize pain management in these patients. Medications like tricyclic antidepressants, serotonin-norepinephrine reuptake Inhibitor (SNRIs), and gabapentinoids are first-line treatments followed by opioids, cannabinoids, and other drugs. There are limited studies on the treatment of NP.

Myofascial Pain Syndrome (MPS) is a regional pain disorder that affects every age-group and is characterized by the presence of trigger points (TrPs) within muscles or fascia. MPS is typically diagnosed via physical exam, and the general agreement for diagnostic criteria includes the presence of TrPs, pain upon palpation, a referred pain pattern, and a local twitch response. The prevalence of MPS among patients presenting to medical clinics due to pain ranges anywhere from 30 to 93%. This may be due to the lack of clear criteria and guidelines in diagnosing MPS. Despite the prevalence of MPS, its pathophysiology remains incompletely understood. There are many different ways to manage and treat MPS. Some include exercise, TrP injections, medications, and other alternative therapies. More research is needed to form uniformly-accepted diagnostic criteria and treatments.

Chronic pain is typically defined as pain that persists after acute tissue damage and inflammation or as pain that follows a chronic disease process and lasts more than three months. Because of its debilitating impact on the quality of life of patients, recent research aims to investigate the mechanisms behind nociception to discover novel therapeutic agents to alleviate pain. One such target is the neuropeptide calcitonin gene-related peptide (CGRP), which has shown to play an integral role in migraine pathophysiology. Effective treatments of migraines with CGRP antagonists have stimulated our efforts toward checking a possible involvement of CGRP in nonheadache pain conditions such as hypertension, congestive heart failure, Alzheimer's disease, and vascular ischemia. Here, we provide a brief overview of chronic pain, with a particular emphasis on the role of CGRP as a fundamental mediator of nociceptive pain as well as a target for novel therapeutic agents.

Pharmacogenomics is the study of how genetic differences between individuals affect pharmacokinetics and pharmacodynamics. These differences are apparent to clinicians when taking into account the wide range of responses to medications given in clinical practice. A review of literature involving pharmacogenomics and pain management was performed. The implementation of preoperative pharmacogenomics will allow us to better care for our patients by delivering personalized, safer medicine. This review describes the current state of pharmacogenomics as it relates to many aspects of clinical practice and how clinicians can use these tools to improve patient outcomes.

Chronic pelvic pain (CPP) in women is defined as noncyclical and persistent pain lasting more than six months perceived to be related to the pelvis. There are many etiologies that can cause CPP, including gynecologic, urologic, gastrointestinal, musculoskeletal, neurologic, and psychosocial. There is a strong association between psychological factors and CPP. It has been noted that almost half of women being treated for CPP report a history of sexual, physical, or emotional trauma. Women with CPP have been noted to have higher rates of psychological disorders in comparison to their peers. For men, the most common etiology for CPP is chronic prostatitis and there are also correlations with psychological disorders. There are many different treatment options for CPP: surgical, pharmacological, and non-pharmacological (alternative therapies). Cognitive-behavioral therapy may be another option when treating chronic pelvic pain syndrome and should be considered.

Angina pectoris is defined as substernal chest pain that is typically exacerbated by exertion, stress, or other exposures. There are various methods of treatment for angina. Lifestyle modification and pharmacological management are considered as conservative treatments. If these medications do not result in the resolution of pain, more invasive approaches are an option, like coronary revascularization. Refractory angina (RA) is differentiated from acute or chronic angina based on the persistence of symptoms despite conventional therapies. Overall, the prevalence of RA is estimated to be 5%-15% in patients with coronary artery disease, which can account for up to 1,500,000 current cases and 100,000 new cases in the United States per year. Spinal cord stimulation treatment is a viable option for patients who are suffering from RA pain and are either not candidates for revascularization surgery or are currently not being well managed on more traditional treatments. Many studies show a positive result.

Lateral epicondylitis (LE), also known as tennis elbow, is the most common cause of elbow pain in adults, with approximately 1-3% of the general population being afflicted. Although the condition is usually self-limiting, pain can be a major hindrance, limiting daily activity and the work capacity of patients. As a result, many treatment options have become available with the aim to shorten the duration of the disease and increase the quality of life. Steroid injections, NSAIDs, topical creams, platelet-rich plasma, physical therapy, and kinesiotaping are considered conservative treatments, while surgical options are last-resort treatments reserved for refractory LE. In this review, we will provide a brief summary of LE and focus on addressing conservative and minimally invasive interventional options for the treatment of LE.

Fibromyalgia is a complex disease process that is as prevalent as it is poorly understood. Research into the pathophysiology is ongoing, and findings will likely assist in identifying new therapeutic options to augment those in existence today that are still insufficient for the care of a large population of patients. Recent evidence describes the use of cannabinoids in the treatment of fibromyalgia. This study provides a systematic, thorough review of the evidence alongside a review of the seminal data regarding the pathophysiology, diagnosis, and current treatment options. Fibromyalgia is characterized by widespread chronic pain, fatigue, and depressive episodes without an organic diagnosis, which may be prevalent in up to 10% of the population and carries a significant cost in healthcare utilization, morbidity, a reduced quality of life, and productivity. It is frequently associated with psychiatric comorbidities. The diagnosis is clinical and usually prolonged, and diagnostic criteria continue to evolve. Some therapies have been previously described, including neuropathic medications, milnacipran, and antidepressants. Despite some level of efficacy, only physical exercise has strong evidence to support it. Cannabis has been used historically to treat different pain conditions since ancient times. Recent advances allowed for the isolation of the active substances in cannabis and the production of cannabinoid products that are nearly devoid of psychoactive influence and provide pain relief and alleviation of other symptoms. Many of these, as well as cannabis itself, are approved for use in chronic pain conditions. Evidence supporting cannabis in chronic pain conditions is plentiful; however, in fibromyalgia, they are mostly limited. Only a handful of randomized trials exists, and their objectivity has been questioned. However, many retrospective trials and patient surveys suggest the significant alleviation of pain, improvement in sleep, and abatement of associated symptoms. Evidence supporting the use of cannabis in chronic pain and specifically in fibromyalgia is being gathered as the use of cannabis increases with current global trends. While the current evidence is still limited, emerging data do suggest a positive effect of cannabis in fibromyalgia. Cannabis use is not without risks, including psychiatric, cognitive, and developmental as well as the risks of addiction. As such, clinical judgment is warranted to weigh these risks and prescribe to patients who are more likely to benefit from this treatment. Further research is required to define appropriate patient selection and treatment regimens.

Acupuncture is a practice based on traditional Chinese medicine, in which needles are used to restore the body's internal balance. Recently, there has been growing interest in the use of acupuncture for various pain conditions. Acupuncture's efficacy in five pain conditions-low back pain (LBP), migraines, fibromyalgia, neck pain, and abdominal pain-was evaluated in this evidence-based, comprehensive review. Based on the most recent evidence, migraine and fibromyalgia are two conditions with the most favorable outcomes after acupuncture. At the same time, abdominal pain has the least evidence for the use of acupuncture. Acupuncture is efficacious for reducing pain in patients with LBP, and for short-term pain relief for those with neck pain. Further research needs to be done to evaluate acupuncture's efficacy in these conditions, especially for abdominal pain, as many of the current studies have a risk of bias due to lack of blinding and small sample size.

Background: The COVID-19 pandemic has worsened the pain and suffering of chronic pain patients due to stoppage of “elective” interventional pain management and office visits across the United States. The reopening of America and restarting of interventional techniques and elective surgical procedures has started. Unfortunately, with resurgence in some states, restrictions are once again being imposed. In addition, even during the Phase II and III of reopening, chronic pain patients and interventional pain physicians have faced difficulties because of the priority selection of elective surgical procedures. Chronic pain patients require high intensity care, specifically during a pandemic such as COVID-19. Consequently, it has become necessary to provide guidance for triaging interventional pain procedures, or related elective surgery restrictions during a pandemic. Objectives: The aim of these guidelines is to provide education and guidance for physicians, healthcare administrators, the public and patients during the COVID-19 pandemic. Our goal is to restore the opportunity to receive appropriate care for our patients who may benefit from interventional techniques. Methods: The American Society of Interventional Pain Physicians (ASIPP) has created the COVID-19 Task Force in order to provide guidance for triaging interventional pain procedures or related elective surgery restrictions to provide appropriate access to interventional pain management (IPM) procedures in par with other elective surgical procedures. In developing the guidance, trustworthy standards and appropriate disclosures of conflicts of interest were applied with a section of a panel of experts from various regions, specialties, types of practices (private practice, community hospital and academic institutes) and groups. The literature pertaining to all aspects of COVID-19, specifically related to epidemiology, risk factors, complications, morbidity and mortality, and literature related to risk mitigation and stratification was reviewed. The evidence -- informed with the incorporation of the best available research and practice knowledge was utilized, instead of a simplified evidence-based approach. Consequently, these guidelines are considered evidence-informed with the incorporation of the best available research and practice knowledge. Results: The Task Force defined the medical urgency of a case and developed an IPM acuity scale for elective IPM procedures with 3 tiers. These included emergent, urgent, and elective procedures. Examples of emergent and urgent procedures included new onset or exacerbation of complex regional pain syndrome (CRPS), acute trauma or acute exacerbation of degenerative or neurological disease resulting in impaired mobility and inability to perform activities of daily living. Examples include painful rib fractures affecting oxygenation and post-dural puncture headaches limiting the ability to sit upright, stand and walk. In addition, urgent procedures include procedures to treat any severe or debilitating disease that prevents the patient from carrying out activities of daily living. Elective procedures were considered as any condition that is stable and can be safely managed with alternatives. Limitations: COVID-19 continues to be an ongoing pandemic. When these recommendations were developed, different stages of reopening based on geographical regulations were in process. The pandemic continues to be dynamic creating every changing evidence-based guidance. Consequently, we provided evidence-informed guidance. Conclusion: The COVID-19 pandemic has created unprecedented challenges in IPM creating needless suffering for pain patients. Many IPM procedures cannot be indefinitely postponed without adverse consequences. Chronic pain exacerbations are associated with marked functional declines and risks with alternative treatment modalities. They must be treated with the concern that they deserve. Clinicians must assess patients, local healthcare resources, and weigh the risks and benefits of a procedure against the risks of suffering from disabling pain and exposure to the COVID-19 virus. Key words: Coronavirus, COVID-19, interventional pain management, COVID risk factors, elective surgeries, interventional techniques, chronic pain, immunosuppression

Background: The COVID pandemic has impacted almost every aspect of human interaction, causing global changes in financial, health care, and social environments for the foreseeable future. More than 1.3 million of the 4 million cases of COVID-19 confirmed globally as of May 2020 have been identified in the United States, testing the capacity and resilience of our hospitals and health care workers. The impacts of the ongoing pandemic, caused by a novel strain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), have far-reaching implications for the future of our health care system and how we deliver routine care to patients. The adoption of social distancing during this pandemic has demonstrated efficacy in controlling the spread of this virus and has been the only proven means of infection control thus far. Social distancing has prompted hospital closures and the reduction of all non-COVID clinical visits, causing widespread financial despair to many outpatient centers. However, the need to treat patients for non-COVID problems remains important despite this pandemic, as care must continue to be delivered to patients despite their ability or desire to report to outpatient centers for their general care. Our national health care system has realized this need and has incentivized providers to adopt distance-based care in the form of telemedicine and video medicine visits. Many institutions have since incorporated these into their practices without financial penalty because of Medicare’s 1135 waiver, which currently reimburses telemedicine at the same rate as evaluation and management codes (E/M Codes). Although the financial burden has been alleviated by this policy, the practitioner remains accountable for providing proper assessment with this new modality of health care delivery. This is a challenge for most physicians, so our team of national experts has created a reference guide for musculoskeletal and neurologic examination selection to retrofit into the telemedicine experience. Objectives: To describe and illustrate musculoskeletal and neurologic examination techniques that can be used effectively in telemedicine. Study Design: Consensus-based multispecialty guidelines. Setting: Tertiary care center. Methods: Literature review of the neck, shoulder, elbow, wrist, hand, lumbar, hip, and knee physical examinations were performed. A multidisciplinary team comprised of physical medicine and rehabilitation, orthopedics, rheumatology, neurology, and anesthesia experts evaluated each examination and provided consensus opinion to select the examinations most appropriate for telemedicine evaluation. The team also provided consensus opinion on how to modify some examinations to incorporate into a nonhealth care office setting. Results: Sixty-nine examinations were selected by the consensus team. Household objects were identified that modified standard and validated examinations, which could facilitate the examinations.The consensus review team did not believe that the modified tests altered the validity of the standardized tests.Limitations: Examinations selected are not validated for telemedicine. Qualitative and quantitative analyses were not performed. Conclusions: The physical examination is an essential component for sound clinical judgment and patient care planning. The physical examinations described in this manuscript provide a comprehensive framework for the musculoskeletal and neurologic examination, which has been vetted by a committee of national experts for incorporation into the telemedicine evaluation. Key words: COVID, pain, telemedicine, physical examination, spine, shoulder, elbow, hand, hip, knee

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

Background: The aim of this study was to examine and appreciate characteristics of malpractice lawsuits brought against interventional pain specialists. Objectives: To examine and appreciate characteristics of malpractice lawsuits brought against interventional pain specialists. Study Design: Retrospective review. Setting: Jury verdicts and settlement reports of state and federal malpractice cases involving interventional pain practitioners from January 1, 1988, to January 1, 2018 were gathered from the Westlaw online legal database. Methods: Jury verdicts and settlement reports of state and federal malpractice cases involving interventional pain practitioners from January 1, 1988, to January 1, 2018 were gathered from the Westlaw online legal database. Data collected for each case included year, state, patient age, patient gender, defendant specialty, legal outcome, award amount, alleged cause of malpractice, and factors in plaintiff’s decision to file. After elimination of duplicates and applying inclusion/ exclusion criteria to our initial search yielding over 1,500 cases, a total of 82 cases were included in this study. Results: A total of 57.3% of cases resulted in a jury verdict in favor of the defendant, whereas 41.5% favored the plaintiff. When comparing cases that were performed in the operating room to cases performed outside the operating room, we found the jury verdicts to favor the plaintiff 83.3% of the time for operating room procedures (P = 0.003). In other words, interventional pain practitioners were more likely to be found at fault for complications from procedures performed in the operating room. To eliminate confounders, a logistical regression was performed and confirmed operating room procedures were an independent predictor of a verdict awarded to the plaintiff (P = 0.008). The median amount awarded to the plaintiff for all cases was $333,000, and the single highest award amount was $36,636,288. The median payout for operating room procedures was $450,000 (P = 0.010), which was significantly different from the median payout for nonoperating room procedures. Procedure categorization demonstrated a statistically significant difference in jury verdicts (P = 0.01411) and procedural error was the leading reason for pursuing litigation, followed by lack of informed consent and unnecessary procedure performed. Limitations: There is more than one database that captures medicolegal claims brought against practitioners. Westlaw, which has been previously utilized by other studies, is only one of them and the extent to which overlap exists in unclear. For each, data input are not necessarily consistent and data capture are not complete. As a result, there could exist a skew toward more severe complications and the details of individual cases likely vary. During data extraction, we found that all details of the procedure were not always included. For example, not all cases specified the type of injectate utilized for epidural injection (i.e., local anesthetic, steroid, mixture, and others) or route of injection (i.e., transforaminal vs. interlaminar). Moreover, as previously mentioned, cases that are settled out of court or finalized prior to trial are not necessarily reported by the Westlaw database, and therefore were not always included in our data search. Conclusions: Overall, interventional pain medicine physicians were favored by jury verdicts for malpractice claims. However, when filtering by procedure or setting, jury verdicts favored the plaintiff in some cases. Key words: Interventional pain, medical, malpractice, anesthesiology

Introduction Recent years have seen a dramatic escalation of off-label prescribing for gabapentin and pregabalin (gabapentinoids) owing in part to generic versions of each being released over the past two decades, but also in part as a response to increasing calls for multimodal and non-opioid pain management strategies. In this context, several recent articles have been published alleging widespread misuse, with speculations on the unappreciated addictive potential of the gabapentinoid class of drugs. Reports of a 1% population-level abuse prevalence stem from a single internet survey in the UK, and the vanishingly small adverse event outcomes data do not support such frequency. In this targeted narrative review, we aim to disabuse pain physicians and other clinicians, pharmacists, and policymakers of both the positive and negative myths concerning gabapentinoid medications. Results Gabapentinoids inhibit the joint action of voltage-gated calcium channel (VGCC) α2δ subunits in conjunction with the n-methyl-d-aspartate (NMDA) receptor, with subsequent downregulation of VGCC expression and excitatory neurotransmitter release, and possibly synaptogenesis as well, through actions on thrombospondins. These activities reduce the likelihood of central sensitization, which explains in part the efficacy of the gabapentinoids in the management of neuropathic pain. Gabapentinoids also facilitate slow-wave sleep, a relatively rare phenomenon among central nerve system-acting agents, which is also thought to explain some of the therapeutic benefit of the class in conditions such as fibromyalgia. The number needed to treat to see benefit overlaps that of the nonsteroidal anti-inflammatory drugs, but with a considerably improved safety profile. Along these lines, in the context of over 50 million prescriptions per year in the USA alone, the gabapentinoids display remarkably low risk, including risks of misuse, abuse, and dependence. Furthermore, the neurobiology of these agents does not lend plausibility to the allegations, as they have never been shown to elicit dopaminergic activity within the nucleus accumbens, and in addition likely confer a "negative-feedback loop" for habituation and dependence by serving as functional NMDA antagonists, possibly through their actions on thrombospondins. Clinical and epidemiological addictionology studies corroborate the lack of any significant addictive potential of the gabapentinoids, and these drugs are increasingly being used in the treatment of addiction to other substances, with excellent results and no evidence of cross-addiction. However, among individuals with other substance use disorders and, in particular opioid use disorder, there are consistent data showing misuse of gabapentinoids in up to 20% of this population. Although there are allegations of using gabapentinoids to amplify the hedonic effects of opioids, the vast majority of misuse events appear to occur in an attempt to ameliorate opioid withdrawal symptoms. Furthermore, rare but potentially serious respiratory depression may occur, again amplified in the context of opioid or other sedative use. Careful risk:benefit assessment and stratification are warranted when prescription of a gabapentinoid is under consideration, in particular among individuals using opioids. Conclusions Gabapentinoids remain a vital tool in the pain physician’s multimodal armamentarium, but these drugs may not be effective in every clinical situation. Individuals with central sensitization and pain associated with slow-wave sleep deficits and potentially persons with comorbid addictions may benefit the most. The gabapentinoids appear to possess no addictive potential on their own, based on laboratory and clinical data, but they may be abused by persons with opioid use disorders; consequently, cautious risk stratification must take place.

Important elements of the preoperative assessment that should be addressed for the older adult population include frailty, comorbidities, nutritional status, cognition, and medications. Frailty has emerged as a plausible predictor of adverse outcomes after surgery. It is present in older patients and is characterized by multisystem physiologic decline, increased vulnerability to stressors, and adverse clinical outcomes. Preoperative preparation may include a prehabilitation program, which aims to address nutritional insufficiencies, modify chronic polypharmacy, and enhance physical and respiratory conditions prior to hospital admission. Special considerations are taken for particularly high-risk patients, where the approach to prehabilitation can address specific, individual risk factors. Identifying patients who are nutritionally deficient allows practitioners to intervene preoperatively to optimize their nutritional status, and different strategies are available, such as immunonutrition. Previous studies have shown an association between increased frailty and the risk of postoperative complications, morbidity, hospital length of stay, and 30-day and long-term mortality following general surgical procedures. Evidence from numerous studies suggests a potential benefit of including a standard assessment of frailty as part of the preoperative workup of older adult patients. Studies addressing validated frailty assessments and the quantification of their predictive capabilities in various surgeries are warranted.

The management principles of non-obstetric surgery during pregnancy are important concepts for all health care providers to be cognizant of. The goals of non-obstetric surgery are to ensure maternal safety, maintain the pregnancy, and ensure fetal well-being. In this regard, organogenesis occurs roughly between days 7-57 and thus, certain medications have a higher incidence of fetal teratogenicity in this first trimester. Some examples of common surgeries performed urgently or emergently include appendectomies, ovarian detorsions, bowel obstruction, trauma, and cholecystectomies. The choice of anesthetic technique and the selection of appropriate anesthetic drugs should be guided by indication for surgery, the nature of the surgery, and the site of the surgical procedure. Many of the concerns for any patients undergoing urgent or emergent surgery must be considered by anesthesia providers along with steps to ensure the fetus has the best outcome.

Preoperative laboratory testing is often necessary and can be invaluable for diagnosis, assessment, and treatment. However, performing routine laboratory tests for patients who are considered otherwise healthy is not usually beneficial and is costly. It is estimated that $18 billion (U.S.) is spent annually on preoperative testing, although how much is wasteful remains unknown. Ideally, a targeted and comprehensive patient history and physical exam should largely determine whether preprocedure laboratory studies should be obtained. Healthcare providers, primarily anesthesiologists, should remain cost-conscious when ordering specific laboratory or imaging tests prior to surgery based on available literature. We review the overall evidence and key points from the Choosing Wisely guidelines, the identification of potential wasteful practices, possible harms of testing, and key clinical findings associated with preoperative laboratory testing.

Postoperative pulmonary complications (PPCs), estimated between 2.0% and 5.6% in the general surgical population and 20-70% for upper abdominal and thoracic surgeries, are a significant factor leading to poor patient outcomes. Efforts to decrease the incidence of PPCs such as bronchospasm, atelectasis, exacerbations of underlying chronic lung conditions, infections (bronchitis and pneumonia), prolonged mechanical ventilation, and respiratory failure, begins with a detailed preoperative risk evaluation. There are several available preoperative tests to estimate the risk of PPCs. However, the value of some of these studies to estimate PPCs remains controversial and is still debated. In this review, the preoperative risk assessment of PPCs is examined along with preoperative pulmonary tests to estimate risk, intraoperative, and procedure-associated risk factors for PPCs, and perioperative strategies to decrease PPCs. The importance of minimizing these events is reflected in the fact that nearly 25% of postoperative deaths occurring in the first week after surgery are associated with PPCs. This review provides important information to help clinical anesthesiologists to recognize potential risks for pulmonary complications and allows strategies to create an appropriate perioperative plan for patients.

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

Migraine headache is a common, chronic, debilitating disease with a complex etiology. Current therapy for migraine headache comprises either treatments targeting acute migraine pain or prophylactic therapy aimed at increasing the length of time between migraine episodes. Recent evidence suggests that calcium gene-related peptide (CGRP) is a critical component in the pathogenesis of migraines. Fremanezumab, a monoclonal antibody against CGRP, was recently approved by the Food and Drug Administration (FDA) after multiple studies showed that it was well-tolerated, safe, and effective in the treatment of migraines. Further research is needed to elucidate the long-term effects of fremanezumab and CGRP-antagonists in general, and additional data is required in less healthy patients to estimate its effects in these populations and potentially increase the eligible group of recipients. This is a comprehensive review of the current literature on the efficacy and safety of fremanezumab for the treatment of chronic migraine. In this review we provide an update on the epidemiology, pathogenesis, diagnosis, and current treatment of migraine, and summarize the evidence for fremanezumab as a treatment for migraine.