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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.

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

In the midst of the COVID-19 pandemic, data has shown that age-adjusted overdose death rates involving synthetic opioids, psychostimulants, cocaine, and heroin have been increasing, including prescription opioid deaths, which were declining, but, recently, reversing the trends. Contrary to widely held perceptions, the problem of misuse, abuse, and diversion of prescription opioids has been the least of all the factors in recent years. Consequently, it is important to properly distinguish between the role of illicit and prescription opioids in the current opioid crisis. Multiple efforts have been based on consensus on administrative policies for certain harm reduction strategies for individuals actively using illicit drugs and reducing opioid prescriptions leading to curbing of medically needed opioids, which have been ineffective. While there is no denial that prescription opioids can be misused, abused, and diverted, the policies have oversimplified the issue by curbing prescription opioids and the pendulum has swung too far in the direction of severely limiting prescription opioids, without acknowledgement that opioids have legitimate uses for persons suffering from chronic pain. Similar to the opioid crisis, interventional pain management procedures have been affected by various policies being applied to reduce overuse, abuse, and finally utilization. Medical policies have been becoming more restrictive with reduction of access to certain procedures, with the pendulum swinging too far in the direction of limiting interventional techniques. Recent utilization assessments have shown a consistent decline for most interventional techniques, with a 18.7% decrease from 2019 to 2020. The causes for these dynamic changes are multifactorial likely including the misapplication of the 2016 Centers for Disease Control and Prevention (CDC) guidelines for prescribing opioids for chronic pain, the relative ease of access to illicit synthetic opioids and more recently issues related to the COVID-19 pandemic. In addition, recent publications have shown association of dose tapering with overdose or mental health crisis among patients prescribed long-term opioids. These findings are leading to the hypothesis that federal guidelines may inadvertently be contributing to an increase in overall opioid deaths and diminished access to interventional techniques. Together, these have resulted in a fourth wave of the opioid epidemic.A narrative review.The fourth wave results from a confluence of multiple factors, including misapplication of CDC guidelines, the increased availability of illicit drugs, the COVID-19 pandemic, and policies reducing access to interventional procedures. The CDC guidelines and subsequent regulatory atmosphere have led to aggressive tapering up to and including, at times, the overall reduction or stoppage of opioid prescriptions. Forced tapering has been linked to an increase of 69% for overdoses and 130% for mental health crisis. The data thus suggests that the diminution in access to opioid prescriptions may be occurring simultaneously with an increase in illicit narcotic use.Combined with CDC guidelines, the curbing of opioid prescriptions to medically needed individuals, among non-opioid treatments, interventional techniques have been affected with declining utilization rates and medical policies reducing access to such modalities.The opioid overdose waves over the past three decades have resulted from different etiologies. Wave one was associated with prescription opioid overdose deaths and wave two with the rise in heroin and overdose deaths from 1999 to 2013. Wave three was associated with a rise in synthetic opioid overdose deaths. Sadly, wave four continues to escalate with increasing number of deaths as a confluence of factors including the CDC guidelines, the COVID pandemic, increased availability of illicit synthetic opioids and the reduction of access to interventional techniques, which leads patients to seek remedies on their own.

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

Many of the patients undergoing interventional procedures have daily regimens of medications including analgesics, muscle relaxants, and other drugs that can have significant additive/synergistic effects during the perioperative period. Further, many patients also present with comorbid states, including obesity, cardiovascular, and pulmonary disease. Consequently, in the perioperative period, a significant number of patients have suffered permanent neurologic injury, hypoxic brain injury, and even death as a result of over sedation, hypoventilation, and spinal cord injury. In addition, physicians are concerned about aspiration, subsequent complications, and as a result, they ask patients to fast for several hours prior to the procedures. Based on extensive literature and consensus, a minimum fasting period is established as 2 hours before a procedure for clear liquids and 4 hours before procedure for light meals, rather than having all patients fast for 8 hours or even fasting beginning at midnight the night before the procedure. Gastrointestinal stimulants, gastric acid secretion blockers, and antacids may be used, even though not routinely recommended. Due to the nature of chronic pain and anxiety, many patients undergoing interventional techniques may require mild to moderate sedation. Deep sedation and/or general anesthesia for most interventional procedures is considered as unsafe, since the patient cannot communicate acute changes in symptoms, thus, resulting in morbidity and mortality, as well as creating compliance issues. We are adapting the published standards of the American Society of Anesthesiologists for monitoring patients under sedation, regardless of the location of the procedure, either office-based, in a surgery center, or a hospital outpatient department. These standards include monitoring of blood pressure, cardiac rhythm, temperature, pulse oximetry, and continuous quantitative end tidal CO2 monitoring. Sedation must be provided either by qualified anesthesia or non-anesthesia providers, with appropriate understanding of the medications, drug interactions, and resuscitative protocols. Key words: Guidelines, sedation, fasting status, monitoring, neurological complications

The re-engineered definition of clinical guidelines in 2011 from the IOM (Institute of Medicine) states, "clinical practice guidelines are statements that include recommendations intended to optimize patient care that is informed by a systematic review of evidence and an assessment of the benefit and harms of alternative care options." The revised definition distinguishes between the term "clinical practice guideline" and other forms of clinical guidance derived from widely disparate development processes, such as consensus statements, expert advice, and appropriate use criteria.To assess the literature and develop methodology for evidence synthesis and development of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain.A systematic review of the literature including methodology of guideline development encompassing GRADE approach for guidance on evidence synthesis with recommendations.Some of the many factors described in 2011 continue as of 2020 and impede the development of clinical practice guidelines. These impediments include biases due to a variety of conflicts and confluence of interest, inappropriate and poor methodological quality, poor writing and ambiguous presentation, projecting a view that these are not applicable to individual patients or too restrictive with the elimination of clinician autonomy, and overzealous and inappropriate recommendations, either positive, negative, or non-committal. Thus, ideally, a knowledgeable, multidisciplinary panel of experts with true lack of bias and confluence of interest must develop guidelines based on a systematic review of the existing evidence. This manuscript describes evidence synthesis from observational studies, various types of randomized controlled trials (RCTs), and, finally, methodological and reporting quality of systematic reviews. The manuscript also describes various methods utilized in the assessment of the quality of observational studies, diagnostic accuracy studies, RCTs, and systematic reviews.Paucity of publications with appropriate evidence synthesis methodology in reference to interventional techniques.This review described comprehensive evidence synthesis derived from systematic reviews, including methodologic quality and bias measurement. The manuscript described various methods utilized in the assessment of the quality of the systematic reviews, RCTs, diagnostic accuracy studies, and observational studies.

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.

Objective: To determine the influence of prior opioid use on the diagnostic validity of controlled comparative local anesthetic blocks in the diagnosis of facet joint involvement in chronic spinal pain.Methods: Data were evaluated from 438 patients with chronic spinal pain who underwent diagnostic facet joint nerve blocks. Patient data were divided into four groups based on the level of opioid use: group I (no opioid use), group II (low opioid use), group III (moderate opioid use), and group IV (high opioid use). Facet joint involvement was diagnosed utilizing controlled comparative local anesthetic blocks with 1 percent preservative- free lidocaine and 0.25 percent preservative-free bupivacaine.Results: Prior and current opioid use did not show relationship to the diagnostic validity of controlled comparative local anesthetic blocks. Among patients not using opioids (group I), the prevalence of facet joint pain was shown to be 33 percent in the cervical spine, 40 percent in the thoracic spine, and 18 percent in the lumbar spine, with false-positive results with a single lidocaine block of 53 percent, 33 percent, and 54 percent, respectively. Facet joint involvement in patients with opioid use ranged from 37 percent to 53 percent in the cervical spine, 13 percent to 67 percent in the thoracic spine, and 28 percent to 33 percent in the lumbar spine.Conclusions: Overall, this evaluation demonstrated that current or prior opioid use is not associated with interference of the validity of controlled comparative local anesthetic blocks in diagnosing spinal facet jointrelated pain.

Symptomatic lumbar spinal stenosis is a condition affecting a growing number of individuals resulting in significant disability and pain, leading to a multitude of interventions ranging from simple over the counter medication to opioids, and, finally, to complex surgical fusions. After failure of conservative treatment with drug therapy, physical therapy, and other conservative modalities including epidural injections, percutaneous adhesiolysis with targeted delivery of drugs into the epidural space can be offered in lumbar central spinal stenosis prior to minimally invasive surgical options or complex surgical fusions. To date there has been only one systematic review which has assessed the role of percutaneous adhesiolysis in treating central spinal stenosis, compared to post lumbar surgery syndrome which has multiple systematic reviews and randomized controlled trials (RCTs).A systematic review of RCTs and observational studies assessing the role of percutaneous adhesiolysis in managing lumbar central spinal stenosis.To evaluate the effectiveness of percutaneous adhesiolysis in managing central lumbar spinal stenosis, utilizing currently available literature.This systematic review was performed utilizing Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) for literature search, Cochrane review criteria, 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) to assess methodologic quality assessment and qualitative analysis utilizing best evidence synthesis principles, and 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 June 2019. The evidence was summarized utilizing principles of the best evidence synthesis on a scale of 1 to 5.The primary outcome or hard endpoint was defined as the proportion of patients with 50% pain relief and improvement in functionality, whereas the secondary outcome measures or soft endpoints were pain relief and/or improvement in functionality. Short-term effectiveness was defined as improvement of 6 months or less, whereas long-term effectiveness was defined as more than 6 months.Based on search criteria, 9 manuscripts were identified and considered for inclusion with final inclusion of 2 RCTs and 4 observational studies in this systematic review and 5 studies for single arm meta-analysis. The results showed Level II evidence for short-term and long-term improvement in pain and function with application of percutaneous adhesiolysis in managing central lumbar spinal stenosis.There was a significant paucity of evidence assessing the role of percutaneous adhesiolysis in managing lumbar central spinal stenosis, leading to Level II or strong evidence.Overall, the present analysis shows Level II (moderate) evidence for percutaneous adhesiolysis in managing lumbar central spinal stenosis based on relevant high quality RCTs and observational studies.Lumbar central spinal stenosis, percutaneous adhesiolysis, randomized controlled trials, systematic reviews, neuroplasty.

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.

Post lumbar surgery syndrome is common and often results in chronic, persistent pain and disability, which can lead to multiple interventions. After failure of conservative treatment, either surgical treatment or a nonsurgical modality of treatment such as epidural injections, percutaneous adhesiolysis are often contemplated in managing post lumbar surgery syndrome. Multiple previous systematic reviews have reached discordant conclusions about the level of evidence for the effectiveness of percutaneous adhesiolysis in managing post lumbar surgery syndrome and other conditions.A systematic review of previously published systematic reviews assessing efficacy of percutaneous adhesiolysis in managing post lumbar surgery syndrome.To evaluate the value and validity of previous systematic reviews performed after 2015 on effectiveness of percutaneous adhesiolysis in managing chronic refractory low back and lower extremity pain secondary to post lumbar surgery syndrome.Previous systematic reviews on percutaneous adhesiolysis were evaluated. The quality of each systematic review was assessed by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and A Measurement Tool to Assess Systematic Reviews (AMSTAR).The randomized trials included in the available systematic reviews were assessed by Cochrane review criteria and Interventional Pain Management techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) for methodologic quality.Data sources included relevant systematic reviews and the randomized trials included in those systematic reviews published since 2015 with searches of PubMed, Cochrane reviews, and Google Scholar through February 2019.Outcome measures were significant improvement defined as 50% pain relief and improvement in functional status. Short-term efficacy was defined as improvement of 6 months or less, whereas long-term efficacy was defined as more than 6 months.Three systematic reviews and 4 randomized controlled trials (RCTs) of post lumbar surgery syndrome with chronic refractory low back and lower extremity pain showed notable evidence of significant pain relief. Only one systematic review, which was of low quality with inappropriate analysis, showed lack of evidence.Overall, the present analysis shows Level I evidence for percutaneous adhesiolysis based on significant evidence from published RCTs and 3 of the 4 systematic reviews.Post lumbar surgery syndrome, epidural fibrosis, percutaneous adhesiolysis, systematic reviews, randomized controlled trials.

The Interventional Pain Management Ladder reflects a possible paradigm disruption in chronic pain management. For treatment of chronic pain after failure of pharmacotherapy, the standard of care should shift to less-invasive interventional pain management as the preferred second-line treatment prior to more tissue-disruptive spine surgery. Spinal cord stimulation with neuromodulation is an effective, reversible, and minimally invasive interventional therapy for many types of chronic and difficult-to-treat pain. This chapter presents a modern approach of least invasive therapies first prior to more tissue disruptive measures and aligns chronic pain care with treatment of other serious medical conditions, such as heart attack and stroke.

Since October 1, 2015, the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) was integrated into U.S. medical practices. This monumental transition seemingly occurred rather unceremoniously, despite significant opposition and reservations having been expressed by the provider community. In prior publications, we have described various survival strategies for interventional pain physicians. The regulators and beneficiaries of system – CMS, consultants, and health information technology industry are congratulating themselves for a job well done. Nonetheless, this transition comes at an immeasurable financial and psychological drain on providers. However, a rude awakening may be making its way with expiration of initial concessions from government and private payers. This manuscript provides a template for interventional pain management professionals with multiple steps for seamless navigation, including descriptions of the most commonly used codes, navigation through ICD-10-CM manual, steps for correct coding, and finally, detailed coding descriptions for various interventional techniques. Key words: ICD-9-CM (International Classification of Diseases, Ninth revision, Clinical Modification), ICD-10, ICD-10-CM (International Classification of Diseases, 10th Revision), Health Insurance Portability and Accountability Act (HIPAA), Health Information Technology (HIT)

Diagnostic facet joint nerve blocks have been utilized in the diagnosis of cervical facet joint pain in patients without disk herniation or radicular pain due to a lack of reliable noninvasive diagnostic measures. Therapeutic interventions include intra-articular injections, facet joint nerve blocks and radiofrequency neurotomy. The diagnostic accuracy and effectiveness of facet joint interventions have been assessed in multiple diagnostic accuracy studies, randomized controlled trials (RCTs), and systematic reviews in managing chronic neck pain. This assessment shows there is Level II evidence based on a total of 11 controlled diagnostic accuracy studies for diagnosing cervical facet joint pain in patients without disk herniation or radicular pain utilizing controlled diagnostic blocks. Due to significant variability and internal inconsistency regarding prevalence in a heterogenous population; despite 11 studies, evidence is determined as Level II. Prevalence ranged from 36% to 67% with at least 80% pain relief as the criterion standard with a false-positive rate ranging from 27% to 63%. The evidence is Level II for the long-term effectiveness of radiofrequency neurotomy and facet joint nerve blocks in managing cervical facet joint pain. There is Level III evidence for cervical intra-articular injections.

The unfunded mandate for the implementation of International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) is scheduled October 1, 2015. The development of ICD-10-CM has been a complicated process. We have endeavored to keep Interventional Pain Management doctors apprised via a variety of related topical manuscripts. The major issues relate to the lack of formal physician participation in its preparation. While the American Health Information Management Association (AHIMA) and American Hospital Association (AHA) as active partners in its preparation. Centers for Medicare and Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC) are major players; 3M and Blue Cross Blue Shield Association are also involved. The cost of ICD-10-CM implementation is high, similar to the implementation of electronic health records (EHRs), likely consuming substantial resources. While ICD-10, utilized worldwide, includes 14,400 different codes, ICD-10-CM, specific for the United States, has expanded to 144,000 codes, which also includes procedural coding system. It is imperative for physicians to prepare for the mandatory implementation. Conversion from ICD-9-CM to ICD-10-CM coding in interventional pain management is not a conversion of one to one that can be easily obtained from software packages. It is a both a difficult and time-consuming task with each physician, early on, expected to spend on estimation at least 10 minutes per visit on extra coding for established and new patients. For interventional pain physicians, there have been a multitude of changes, including creation of new codes and confusing conversion of existing codes. This manuscript describes a variety of codes that are relevant to interventional pain physicians and often utilized in daily practices. It is our objective that this manuscript will provide coding assistance to interventional pain physicians. Key words: ICD-9-CM (International Classification of Diseases, Ninth revision, Clinical Modification), ICD-10, ICD-10-CM (International Classification of Diseases, 10th Revision), Health Insurance Portability and Accountability Act (HIPAA), Health Information Technology (HIT)

Background: Spinal zygapophysial, or facet, joints are a source of axial spinal pain and referred pain in the extremities. Conventional clinical features and other noninvasive diagnostic modalities are unreliable in diagnosing zygapophysial joint pain. Study Design: A systematic review of the diagnostic accuracy of spinal facet joint nerve blocks. Objective: To determine the diagnostic accuracy of spinal facet joint nerve blocks in chronic spinal pain. Methods: A methodological quality assessment of included studies was performed using Quality Appraisal of Reliability Studies (QAREL). Only diagnostic accuracy studies meeting at least 50% of the designated inclusion criteria were utilized for analysis. The level of evidence was classified as Level I to V based on the grading of evidence utilizing best evidence synthesis. Data sources included relevant literature identified through searches of PubMed and other electronic searches published from 1966 through March 2015, Cochrane reviews, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: Studies must have been performed utilizing controlled local anesthetic blocks. The criterion standard must have been at least 50% pain relief from baseline scores and the ability to perform previously painful movements. Results: The available evidence is Level I for lumbar facet joint nerve blocks with the inclusion of a total of 17 studies with dual diagnostic blocks, with at least 75% pain relief with an average prevalence of 16% to 41% and false-positive rates of 25% to 44%. The evidence for diagnosis of cervical facet joint pain with cervical facet joint nerve blocks is Level II based on a total of 11 controlled diagnostic accuracy studies, with significant variability among the prevalence in a heterogenous population with internal inconsistency. The prevalence rates ranged from 36% to 67% with at least 80% pain relief as the criterion standard and a false-positive rate of 27% to 63%. The level of evidence for the diagnostic accuracy of thoracic facet joint nerve blocks is Level II with 80% or higher pain relief as the criterion standard with a prevalence ranging from 34% to 48% and false-positive rates ranging from 42% to 48%. Limitations: The shortcomings of this systematic review include a paucity of literature related to the thoracic spine, continued debate on an appropriate gold standard, appropriateness of diagnostic blocks, and utility. Conclusion: The evidence is Level I for the diagnostic accuracy of lumbar facet joint nerve blocks, Level II for cervical facet joint nerve blocks, and Level II for thoracic facet joint nerve blocks in assessment of chronic spinal pain. Key words: Chronic spinal pain, lumbar facet or zygapophysial joint pain, cervical facet or zygapophysial joint pain, thoracic facet or zygapophysial joint pain, facet joint nerve blocks, medial branch blocks, controlled comparative local anesthetic blocks

Background: The therapeutic spinal facet joint interventions generally used for the treatment of axial spinal pain of facet joint origin are intraarticular facet joint injections, facet joint nerve blocks, and radiofrequency neurotomy. Despite interventional procedures being common as treatment strategies for facet joint pathology, there is a paucity of literature investigating these therapeutic approaches. Systematic reviews assessing the effectiveness of various therapeutic facet joint interventions have shown there to be variable evidence based on the region and the modality of treatment utilized. Overall, the evidence ranges from limited to moderate. Objective: To evaluate and update the clinical utility of therapeutic lumbar, cervical, and thoracic facet joint interventions in managing chronic spinal pain. Study Design: A systematic review of therapeutic lumbar, cervical, and thoracic facet joint interventions for the treatment of chronic spinal pain. Methods: The available literature on lumbar, cervical, and thoracic facet joint interventions in managing chronic spinal pain was reviewed. The quality assessment criteria utilized were the Cochrane Musculoskeletal Review Group criteria and Interventional Pain Management Techniques – Quality Appraisal of Reliability and Risk of Bias Assessment (IPM – QRB) for randomized trials and Interventional Pain Management Techniques – Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM – QRBNR) for observational studies. The level of evidence was classified at 5 levels from Level I to Level V. Data sources included relevant literature identified through searches on PubMed and EMBASE from 1966 through March 2015, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake consumption. Results: A total of 21 randomized controlled trials meeting appropriate inclusion criteria were assessed in this evaluation. A total of 5 observational studies were assessed. In the lumbar spine, for long-term effectiveness, there is Level II evidence for radiofrequency neurotomy and lumbar facet joint nerve blocks, whereas the evidence is Level III for lumbosacral intraarticular injections. In the cervical spine, for long-term improvement, there is Level II evidence for cervical radiofrequency neurotomy and cervical facet joint nerve blocks, and Level IV evidence for cervical intraarticular injections. In the thoracic spine there is Level II evidence for thoracic facet joint nerve blocks and Level IV evidence for radiofrequency neurotomy for long-term improvement. Limitations: The limitations of this systematic review include an overall paucity of high quality studies and more specifically the lack of investigations related to thoracic facet joint injections. Conclusion: Based on the present assessment for the management of spinal facet joint pain, the evidence for long-term improvement is Level II for lumbar and cervical radiofrequency neurotomy, and therapeutic facet joint nerve blocks in the cervical, thoracic, and lumbar spine; Level III for lumbar intraarticular injections; and Level IV for cervical intraarticular injections and thoracic radiofrequency neurotomy. Key Words: Spinal pain, chronic low back pain, chronic neck pain, chronic thoracic pain, intraarticular facet joint blocks, facet joint nerve blocks, conventional radiofrequency neurotomy, pulsed radiofrequency neurolysis

The forced implementation of ICD-10-CM (International Classification of Diseases, Tenth Revision, Clinical Modification) codes that are specific to the United States, scheduled for implementation October 1, 2015, which is vastly different from ICD-10 (International Classification of Diseases, Tenth Revision), implemented worldwide, which has 14,400 codes, compared to ICD-10-CM with 144,000 codes to be implemented in the United States is a major concern to practicing U.S. physicians and a bonanza for health IT and hospital industry. This implementation is based on a liberal interpretation of the Health Insurance Portability and Accountability Act (HIPAA), which requires an update to ICD-9- CM (International Classification of Diseases, Ninth Revision, Clinical Modification) and says nothing about ICD-10 or beyond. On June 29, 2015, the Supreme Court ruled that the Environmental Protection Agency unreasonably interpreted the Clean Air Act when it decided to set limits on the emissions of toxic pollutants from power plants, without first considering the costs on the industry. Thus, to do so is applicable to the medical industry with the Centers for Medicare and Medicaid Services (CMS) unreasonably interpreting HIPAA and imposing existent extensive regulations without considering the cost. In the United States, ICD-10-CM with a 10-fold increase in the number of codes has resulted in a system which has become so complicated that it no longer compares with any other country. Moreover, most WHO members use the ICD-10 system (not ICD-10-CM) only to record mortality in 138 countries or morbidity in 99 countries. Currently, only 10 countries employ ICD-10 (not ICD-10-CM) in the reimbursement process, 6 of which have a single payer health care system. Development of ICD-10-CM is managed by 4 non-physician groups, known as cooperating parties. They include the Centers for Disease Control and Prevention (CDC), CMS, the American Hospital Association (AHA), and the American Health Information Management Association (AHIMA). The AHIMA has taken the lead with the AHA just behind, both with escalating profits and influence, essentially creating a statutory monopoly for their own benefit. Further, the ICD-10-CM coalition includes 3M which will boost its revenues and profits substantially with its implementation and Blue Cross Blue Shield which has its own agenda. Physician groups are not a party to these cooperating parties or coalitions, having only a peripheral involvement. ICD-10-CM creates numerous deficiencies with 500 codes that are more specific in ICD-9-CM than ICD-10-CM. The costs of an implementation are enormous, along with maintenance costs, productivity, and cash disruptions. Key words: ICD-10-CM, ICD-10, ICD-9-CM (International Classification of Diseases, 10th Revision, Ninth revision, Clinical Modification), Health Insurance Portability and Accountability Act (HIPAA), Health Information Technology (HIT), costs of implementation

Suboptimal operating room (OR) efficiency is a universal complaint among surgeons. Nonetheless, maximizing efficiency is critical to institutional success. Here, we report improvement achieved from low-cost, low-technology measures instituted within a tertiary-care academic medical center/Level I trauma center.Improvements in preadmission testing and OR scheduling, including appointing a senior nurse anesthetist to help direct OR use, were instituted in March 2012. A retrospective review of prospectively maintained OR case data was performed to evaluate time periods before and after program implementation, as well as to assess trends over time. Operating room performance metrics were compared using Mann-Whitney and chi-squared tests. Changes over time were analyzed using linear regression.Data including all surgical cases were available for a 36-month period; 10 months (6,581 cases) before program implementation and 26 months afterward (17,574 cases). Dramatic improvement was seen in first-case on-time starts, which increased from 39.3% to 83.8% (p0.0001). Additionally, the percent utilization of available OR time demonstrated a steady increase (p0.001). After an initial lag, case volume also improved, evident by an increase observed in the 12-month rolling average of cases per month (p0.001). The increase in case volume occurred during peak OR time (7 am to 5 pm), and did not result from adding cases after hours (5 pm to 11 pm).After many years of what seemed an insoluble problem, simple changes fostering collaboration among services, including active management of the OR schedule and transparent data, have resulted in substantial improvement in OR efficiency and case volume.

The Balanced Budget Act which became law in 1997 was designed to help stem the increasing in costs of healthcare. The Sustainable Growth Rate (SGR) formula was incorporated into that law as a method of helping balance the budget through a complex formula tying reimbursement to the growth in the economy. Soon after its inception, the flawed nature of the formula, linking the balancing of the federal budget to physician professional fees was realized. Congress has provided multiple short-term fixes known as SGR patches over the years so as to avoid generally progressively larger negative corrections to professional reimbursement. The near annual SGR correction requirement has been compared to Groundhog Day in the legislative arena. Over the years, physician and other providers faced numerous looming, large cuts. Most recently, on April 1, 2015 physicians faced a 21.2% cut in provider payments. To the surprise of many, in April 2015 a bipartisan bicameral effort permanently repealed the Medicare SGR formula for controlling provider payment. The repeal of SGR means the temporary measures to override the growth rate formula will no longer dominate Medicare policy discussions and now the focus turns to continue payment reforms. The MACRA provides physicians and other health care professionals with stable fee update for 5 years and it follows with a new incentive program, termed the Merit-based Incentive Payment System (MIPS) replacing and consolidating preexisting incentive payment programs: meaningful use of electronic health records (EHR), physician quality reporting system, and the value-based payment modified. Thus, payments to clinicians will be subjected to adjustments based on participation in MIPS or other approved alternative payment mechanisms. This legislation also creates numerous other regulations. The MACRA has been criticized for providing insufficient statutory updates, enacting a flawed quality and performance improvement program associated with MIPS and inappropriate use of utilization and payment data. Thus, the MACRA offers physicians a predictable schedule for Medicare rates – a carrot, and controls the physician behaviors with payment reforms analogous to a stick. Thus, it could be said that this legislation embodies some good, bad, and ugly aspects. Key words: Balanced Budget Act, sustainable growth rate, alternative payment models, Medicare Access and CHIP Reauthorization Act of 2015, Merit-based Incentive Payment System, payment reform, payment modernization, health information technology

Scientific peer review is pivotal in health care research in that it facilitates the evaluation of findings for competence, significance, and originality by qualified experts. While the origins of peer review can be traced to the societies of the eighteenth century, it became an institutionalized part of the scholarly process in the latter half of the twentieth century. This was a response to the growth of research and greater subject specialization. With the current increase in the number of specialty journals, the peer review process continues to evolve to meet the needs of patients, clinicians, and policy makers. The peer review process itself faces challenges. Unblinded peer review might suffer from positive or negative bias towards certain authors, specialties, and institutions. Peer review can also suffer when editors and/or reviewers might be unable to understand the contents of the submitted manuscript. This can result in an inability to detect major flaws, or revelations of major flaws after acceptance of publication by the editors. Other concerns include potentially long delays in publication and challenges uncovering plagiarism, duplication, corruption and scientific misconduct. Conversely, a multitude of these challenges have led to claims of scientific misconduct and an erosion of faith. These challenges have invited criticism of the peer review process itself. However, despite its imperfections, the peer review process enjoys widespread support in the scientific community. Peer review bias is one of the major focuses of today’s scientific assessment of the literature. Various types of peer review bias include content-based bias, confirmation bias, bias due to conservatism, bias against interdisciplinary research, publication bias, and the bias of conflicts of interest. Consequently, peer review would benefit from various changes and improvements with appropriate training of reviewers to provide quality reviews to maintain the quality and integrity of research without bias. Thus, an appropriate, transparent peer review is not only ideal, but necessary for the future to facilitate scientific progress. Key words: Scientific research, peer review process, scientific publications, peer review bias, blinded peer review, scientific misconduct.

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.

Research into interventional techniques in managing chronic spinal pain continues to be challenging, mystifying, confusing, and biased. Insight, or lack thereof, into placebo and nocebo phenomena contributes mightily to these difficulties. Unfortunately, placebo-nocebo responses are the subject of numerous controversies and challenges from not only a research perspective, but also clinical perspective. While interventionalists consider the biggest threat to interventional pain management research is inappropriate and outdated interpretation of the data, a greater problem is the misuse of the placebo response in research, with the declaration that all and everything as a placebo effect: with a misinterpretation of the nature of the placebo the, associated conclusions can be inaccurate.Researchers have been aware of placebo and nocebo effects for decades, even though misunderstandings and misgivings continue to be seen in scientific studies. In simplistic terms, placebo and nocebo had been understood to indicate improving or worsening of symptoms that occur during treatment with placebo/nocebo drugs or modalities. However, research has demonstrated that such terminology does not necessarily reflect "true" placebo effect or nocebo response. These effects are based on numerous factors, including natural course of a disease, spontaneous remission, regression to the mean, and a multitude of other conceptual, explanatory, and moral challenges. In modern clinical research, a neutral substance called placebo has been mainly used as a comparison factor rather than being studied itself, while the nocebo response has only been minimally studied.A major misconception involves active placebo, a concept that has been extended beyond the administration of inert substances. The definition of active placebo of an active agent given to a patient, even though the pharmacologic action of the active agent is not known to be beneficial, has been converted to conveniently change many of the treatments which are effective on their own to be defined as placebos, often leading to conclusions that none of the interventions are effective. This review focuses on a multitude of controversies surrounding placebo and nocebo phenomena in research and clinical applications. The discussion includes a focus on unsolved, forgotten, and ignored features of placebo responses in medicine, and provides an appropriate understanding of placebo and nocebo phenomena in interventional pain management. To that effect, this review also describes therapeutic placebos, research with open placebos, and improvements in understanding clinical applications of present interventional pain management research.

Randomized controlled trials are considered the hallmark of evidence-based medicine. This conveys the idea that up-to-date evidence applied consistently in clinical practice, in combination with clinicians’ individual expertise and patients own preference/expectations are enjoined to achieve the best possible outcome. Since its inception in 1990s, evidence-based medicine has evolved in conjunction with numerous changes in the healthcare environment. However, the benefits of evidence-based medicine have not materialized for spinal pain including surgical interventions. Consequently, the debate continues on the efficacy and medical necessity of multiple interventions provided in managing spinal pain. Friedly et al published a randomized controlled trial of epidural glucocorticoid injections for spinal stenosis in the July 2014 edition of the highly prestigious New England Journal of Medicine,. This was accompanied by an editorial from Andersson. This manuscript provided significant sensationalism for the media and confusion for the spine community. This randomized trial of epidural glucocorticoid injections for spinal stenosis and accompanying editorial concluded that epidural injections of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injections of lidocaine alone, with the editorial emphasizing proceeding directly to surgical intervention. In addition media statements by the authors also emphasized the idea that exercise or surgery might be better options for patients suffereing from narrowing of the spinal canal. The interventional pain management community believes that there are severe limitations to this study, manuscript, and accompanying editorial. The design, inclusion criteria, outcomes assessment, analysis of data and interpretation, and conclusions of this trial point to the fact that this highly sophisticated and much publicized randomized trial may not be appropriate and lead to misinformation. The design of the trial was inappropriate with failure to include existing randomized trials, with inclusion criteria that did not incorporate conservative management,or caudal epidural injections. Simultaneously, acute pain patients were included, multilevel stenosis and various other factors were not identified. The interventions included lumbar interlaminar and transforaminal epidural injections with highly variable volumes of medication being injected per patient. Outcomes assessment was not optimal with assessment of the patients at 3 and 6 weeks for a procedure which provides on average 3 weeks of relief and utilizing an instrument which is more appropriately utilized in acute and subacute low back pain. Analysis of the data was hampered by inadequate subgroup analysis leading to inappropriate interpretation. Based on the available data epidural local anesthetic with steroids was clearly superior at 3 weeks and potentially at 6 weeks. Further, both treatments were effective considering the baseline to 3 week and 6 week assessment, appropriate subgroup analysis seems to have yielded significant superiority for interlaminar epidural injections compared to transforaminal epidural injections with local anesthetic with or without steroids specifically with proportion of patients achieving greater than 50% improvement at 3 and 6 week levels. This critical assessment shows that this study suffers from a challenging design, was premised on the exclusion of available highquality literature, and had inadequate duration of follow-up for an interventional technique with poor assessment criteria and reporting. Finally the analysis and interpretation of data has led to inaccurate and inappropriate conclusions which we do not believe is based on scientific evidence. Key words: Chronic low back pain, central spinal stenosis, epidural injections, local anesthetics, steroids, randomized trials, outcomes assessment

On April 23, 2014, the Food and Drug Administration (FDA) issued a letter of warning that injection of corticosteroids into the epidural space of the spine may result in rare, but serious adverse events, including “loss of vision, stroke, paralysis, and death.” The advisory also advocated that patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. In addition, the FDA stated that the effectiveness and safety of the corticosteroids for epidural use have not been established, and the FDA has not approved corticosteroids for such use. To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA’s Safe Use Initiative convened a panel of experts including pain management experts to help define the techniques for such injections with the aim of reducing preventable harm. The panel was unable to reach an agreement on 20 proposed items related to technical aspects of performing epidural injections. Subsequently, the FDA issued the above referenced warning and a notice that a panel will be convened in November 2014. This review assesses the inaccuracies of the warning and critically analyzes the available literature. The literature has been assessed in reference to alternate techniques and an understanding of the risk factors when performing transforaminal epidural injections in the cervical, thoracic, and lumbar regions, ultimately resulting in improved safety. The results of this review show the efficacy of epidural injections, with or without steroids, in a multitude of spinal ailments utilizing caudal, cervical, thoracic, and lumbar interlaminar approaches as well as lumbar transforaminal epidural injections . The evidence also shows the superiority of steroids in managing lumbar disc herniation utilizing caudal and lumbar interlaminar approaches without any significant difference as compared to transforaminal approaches, either with local anesthetic alone or local anesthetic and steroids combined. In conclusion, the authors request that the FDA modify the warning based on the evidence. Key words: Chronic pain, epidural injections, epidural steroids, local anesthetic, radicular artery, complication.

The actions and regulations of the Food and Drug Administration (FDA) are crucial to the entire population of the US, specifically the public who take a multitude of drugs and providers who prescribe drugs and devices. Further, the FDA is relevant to investors, specifically in regards to biotech and pharmaceutical companies involved in developing new drugs. The FDA has been criticized for a lack of independence on the one hand and excessive regulatory and expanding authority without evidence and consistency of the actions on the other hand. The FDA approved a single-entity, long-acting, hydrocodone product (Zohydro™, Zogenix, San Diego, CA) on October 25, 2013, against the recommendation of the FDA’s own appointed scientific advisory panel, which voted 11 to 2 against the approval of Zohydro. Subsequent to the approval, multiple consumer safety organizations, health care agencies, addiction treatment providers, professional organizations, and other groups on the frontline of the opioid addiction epidemic have expressed concern. In addition, the US Congress and various state attorneys general raised serious concerns about the approval of Zohydro, which is highly addictive and may enhance the opioid addiction epidemic. Supporters of Zohydro contend that it is necessary and essential to manage chronic pain and improve functional status with no additional risk. Over the past 15 years, prescriptions for opioids have skyrocketed with the United States consuming more than 84% of the global oxycodone and more than 99% of the hydrocodone supply. The sharp increase in opioid prescribing has led to parallel increases in opioid addiction and overdose deaths, surpassing motor vehicle injuries in the US. Recent studies assessing the trends of medical use and misuse of opioid analgesics from 2000 to 2011 have concluded that the present trend of the continued increase in the medical use of opioid analgesics appears to contribute to increasing misuse, resulting in multiple health consequences, despite numerous regulations enforced by multiple organizations. The approval of Zohydro and its defense from the FDA were based on a misunderstanding of the prevalence of chronic severe disabling pain. Based on inaccurate data from the Institute of Medicine, in part caused by conflicts of interest, 100 million persons have been described to suffer from severe pain -- the correct number is 22.6 million. This manuscript analyzes 3 important principles of drug approval and utilization based on safety, efficacy, and medical necessity. Based on the limited literature that the authors were able to review including that which was submitted to the FDA by the manufacturers, it appears the safety, efficacy, and medical necessity were not demonstrated. In fact, the study submitted to the FDA showed a 50% pain improvement in only 48% of the patients in the treatment group and 21% of the patients in the placebo group at 85 day follow-up. This is a statistically significant result but its clinical relevance is unknown. The FDA approval decision occurring against the backdrop of the advisory panel recommendation is concerning and may result in serious consequences in the future. Key words: Chronic non-cancer pain, Food and Drug Administration, opioids, Zohydro, misuse, tolerance, addiction, dependency, medical necessity

For pain management, opioid therapy is a mainstay for treating acute pain and relieving moderate to severe chronic pain. Quantitative measurement of opioids and their metabolites in urine is used mainly for confirmation of screened results obtained for clinical and forensic purposes. Due to limitations in interpretation of urine results for pain management testing purposes, the use of blood or serum to assess opioids and their metabolites may be of benefit. This report describes a sensitive liquid chromatography-tandem mass spectrometry method for the detection of hydrocodone and its metabolites hydromorphone, norhydrocodone, and dihydrocodeine, and other common opiates that patients may be taking, including morphine, codeine, oxycodone, and oxymorphone in a single extraction. The method uses solid-phase extraction of 500 µL of sample with quantitation by liquid chromatography-tandem mass spectrometry. The assay is linear from 1.0 to 100 ng/mL and has a between-day coefficient of variation of

Background: Postoperative pain management remains a challenge for clinicians due to unpredictable patient responses to opioid therapy. Some of this variability may result from single nucleotide polymorphisms (SNPs) of the human opioid mu-1 receptor (OPRM1) that modify receptor binding or signal transduction. The OPRM1 variant with the highest frequency is the A118G SNP. However, previous studies have produced inconsistent results regarding the clinical effects of A118G on opioid response. We hypothesized that measurement of serum opioid concentrations, in addition to determining total opioid consumption, may provide a more precise method of assessing the effects of A118G on analgesic response. The current study evaluated the relationship of analgesia, side effects, total hydrocodone consumption, quantitative serum hydrocodone and hydromorphone concentrations, and A118G SNP in postoperative patients following Cesarean section. Methods: 158 women scheduled for Cesarean section were enrolled prospectively in the study. The patients had bupivacaine spinal anesthesia for surgery and received intrathcal morphine with the spinal anesthetic or parenteral morphine for the first 24 hours after surgery. Thereafter, patients received hydrocodone/acetaminophen for postoperative pain control. On postoperative day 3, venous blood samples were obtained for OPRM1 A118G genotyping and serum opioid concentrations. Results: 131 (82.9%) of the subjects were homozygous for the 118A allele of OPRM1 (AA) and 27 (17.1%) carried the G allele (AG/GG). By regression analysis, pain relief was significantly associated with total hydrocodone dose in the AA group (P = 0.01), but not in the AG/GG group (P = 0.554). In contrast, there was no association between pain relief and serum hydrocodone concentration in either group. However, pain relief was significantly associated with serum hydromorphone concentration (a metabolite of hydrocodone) in the AA group (P = 0.004), but not in the AG/GG group (P = 0.724). Conversely, side effects were significantly higher (P < 0.04) in the AG/GG group (mean = 6.4) than in the AA group (mean = 4.4), regardless of adjustment for BMI, pain level, or total dose of hydrocodone. Conclusion: This study found a correlation between pain relief and total hydrocodone dose in patients homozygous for the 118A allele (AA) of the OPRM1 gene, but not in patients with the 118G allele (AG/GG). However, pain relief in 118A patients did not correlate with serum hydrocodone concentrations, but rather with serum hydromorphone levels, the active metabolite of hydrocodone. This suggests that pain relief with hydrocodone may be due primarily to hydromorphone. Although pain relief did not correlate with opioid dose in AG/GG patients, they had a higher incidence of opioid side effects. The correlations identified in this study may reflect the fact that serum opioid concentrations were measured directly, avoiding the inherent imprecision associated with relying solely on total opioid consumption as a determinant of opioid effectiveness. Thus, measurement of serum opioid concentrations is recommended when assessing the role of OPRM1 variants in pain relief. This study supports pharmacogenetic analysis of OPRM1 in conjunction with serum opioid concentrations when evaluating patient responses to opioid therapy. Key words: Cesarean section, female gender, genetic polymorphisms, hydrocodone, hydromorphone, opioid Mu 1 receptor, opioid concentrations, serum, OPRM1; rs1799971, postoperative pain

Increasing utilization of interventional techniques in managing chronic spinal pain, specifically facet joint interventions and sacroiliac joint injections, is a major concern of healthcare policy makers. We analyzed the patterns of utilization of facet and sacroiliac joint interventions in managing chronic spinal pain. The results showed significant increase of facet joint interventions and sacroiliac joint injections from 2000 to 2014 in Medicare FFS service beneficiaries. Overall, the Medicare population increased 35 %, whereas facet joint and sacroiliac joint interventions increased 313.3 % per 100,000 Medicare population with an annual increase of 10.7 %. While the increases were uniform from 2000 to 2014, there were some decreases noted for facet joint interventions in 2007, 2010, and 2013, whereas for sacroiliac joint injections, the decreases were noted in 2007 and 2013. The increases were for cervical and thoracic facet neurolysis at 911.5 % compared to lumbosacral facet neurolysis of 567.8 %, 362.9 % of cervical and thoracic facet joint blocks, 316.9 % of sacroiliac joints injections, and finally 227.3 % of lumbosacral facet joint blocks.

Interventional pain management dates back to 1901, with significant innovations, which include the definition, literature synthesis, pathophysiology, and technical interventions.Interventional pain management and interventional techniques include neural blockade, neural ablative procedures, spinal cord and peripheral nerve stimulation, intrathecal drug delivery systems, minimally invasive lumbar decompression (MILD®), percutaneous endoscopic spinal decompression, and regenerative medicine. In addition, advances are also related to the evidence synthesis of comparative effectiveness research. Expert commentary: Multiple innovations in interventional pain management and potential innovations may reduce costs and improve care and outcomes with proper evidence synthesis and application of principles of evidence-based medicine. Innovations in interventional pain management in managing chronic spinal pain depend on extensive research and appropriate evidence synthesis. Innovations should be developed in conjunction with health care policy based on principles of evidence-based medicine.

The prevalence of chronic low back pain and related disability is rapidly increasing as are the myriad treatments, including epidural injections. Even though epidural injections are one of the most commonly performed procedures in managing low back and lower extremity pain, starting in 1901 with local anesthetic alone, conflicting recommendations have been provided, despite the extensive literature. Recently Chou et al performed a technology assessment review for Agency for Healthcare Research and Quality (AHRQ) part of which was published in Annals of Internal Medicine showing lack of effectiveness of epidural steroid injections in managing lumbar radiculopathy and spinal stenosis. In contrast, multiple other publications have supported the efficacy and use of epidural injections.To assess the efficacy of 3 categories of epidural injections for lumbar and spinal stenosis: performed with saline with steroids, local anesthetic alone, or steroids with local anesthetic and separate facts from opinions.PubMed, Cochrane Library, US National Guideline Clearinghouse, prior systematic reviews, and reference lists. The literature search was performed through August 2015.Randomized trials, either placebo or active control, of epidural injections for lumbar radiculopathy and spinal stenosis.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). Evidence was summarized utilizing principles of best evidence synthesis.Thirty-nine randomized controlled trials met inclusion criteria. There were 9 placebo-controlled trials evaluating epidural corticosteroid injections, either with sodium chloride solution or bupivacaine, compared to placebo injections. There were 12 studies comparing local anesthetic alone to local anesthetic with steroid.A meta-analysis of 5 studies utilizing sodium chloride or bupivacaine with steroid showed a lack of efficacy.A comparison of lidocaine to lidocaine with steroids in 7 studies showed significant effectiveness from baseline to long-term follow-up periods. Meta-analysis showed a similar effectiveness for pain and function without non-inferiority of lidocaine compared to lidocaine with steroid at 3 months and 12 months.The review was restricted to the data available with at least 3 months of follow-up, which excluded some studies. The inclusion criteria were restricted to English language studies.Epidural corticosteroid injections for radiculopathy or spinal stenosis with sodium chloride solution or bupivacaine were shown to be ineffective. Lidocaine alone or lidocaine in conjunction with steroids were significantly effective.

Background: Therapeutic lumbar facet joint interventions are implemented to provide long-term pain relief after the facet joint has been identified as the basis for low back pain. The therapeutic lumbar facet joint interventions generally used for the treatment of low back pain of facet joint origin are intraarticular facet joint injections, lumbar facet joint nerve blocks, and radiofrequency neurotomy. Objective: To evaluate and update the effect of therapeutic lumbar facet joint interventions in managing chronic low back pain. Study Design: A systematic review of therapeutic lumbar facet joint interventions for the treatment of chronic low back pain. Methods: The available literature on lumbar facet joint interventions in managing chronic low back pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventative Services Task Force. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 through June 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: The primary outcome measure was pain relief with short-term relief defined as up to 6 months and long-term relief as 12 months. Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. Results: For this systematic review, 122 studies were identified. Of these, 11 randomized trials and 14 observational studies met inclusion criteria for methodological quality assessment. The evidence for radiofrequency neurotomy is good and fair to good for lumbar facet joint nerve blocks for short- and long-term improvement; whereas the evidence for intraarticular injections and pulsed radiofrequency neurotomy is limited. Limitations: The limitations of this systematic review include the continued paucity of evidence, specifically for intraarticular injection therapy. Conclusion: In summary, there is good evidence for the use of conventional radiofrequency neurotomy, and fair to good evidence for lumbar facet joint nerve blocks for the treatment of chronic lumbar facet joint pain resulting in short-term and long-term pain relief and functional improvement. There is limited evidence for intraarticular facet joint injections and pulsed radiofrequency thermoneurolysis. Key Words: Spinal pain, chronic low back pain, lumbar intraarticular facet joint blocks, lumbar facet joint nerve blocks, lumbar conventional radiofrequency neurotomy, pulsed radiofrequency neurolysis

Background: Chronic persistent neck pain with or without upper extremity pain is common in the general adult population with a prevalence of 48% for women and 38% for men, with persistent complaints in 22% of women and 16% of men. Multiple modalities of treatment are exploding in managing chronic neck pain along with increasing prevalence. However, there is a paucity of evidence for all modalities of treatments in managing chronic neck pain. Controlled studies have supported the existence of cervical facet or zygapophysial joint pain in 36% to 60% in heterogenous population of these patients. However, these studies also have shown false-positive results in 27% to 63% of patients with a single diagnostic block. Study Design: A systematic review of diagnostic cervical facet joint nerve blocks. Objective: To evaluate and update the accuracy of diagnostic facet joint nerve blocks in the diagnosis of facet joint pain. Methods: A methodological quality assessment of included studies was performed using Quality Appraisal of Reliability Studies (QAREL). Only diagnostic accuracy studies meeting at least 50% of the designated inclusion criteria were utilized for analysis. Studies scoring less than 50% are presented descriptively and critically analyzed. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the United States Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to June 2012, and manual searches of the bibliographies of known primary and review articles. Results: Overall, a total of 26 manuscripts were considered for diagnostic accuracy evaluation and 9 manuscripts for studies evaluating various factors influencing the diagnostic validity of facet joint interventions. Based on 9 studies meeting the inclusion criteria utilizing 75% to 100% pain relief as the criterion standard with controlled blocks, the evidence is good for diagnostic accuracy of cervical facet joint pain, with a prevalence of 36% to 60% with a false-positive rate of 27% to 63% with a single block. Based on 2 studies from the same group of authors, the evidence for 75% to 100% pain relief as the criterion standard with a single block is limited. The evidence is limited for a single diagnostic block with 50% to 74% pain relief as the criterion standard, whereas no studies were available assessing the accuracy of 50% to 74% pain relief as the criterion standard with controlled blocks. Limitations: The limitations of this systematic review include a paucity of literature on outcomes, randomized, placebo-controlled trials and a lack of consensus on a gold standard. Conclusions: Diagnostic cervical facet joint nerve blocks are safe, valid, and reliable. The strength of evidence for diagnostic facet joint nerve blocks is good with the utilization of controlled diagnostic blocks with at least 75% pain relief as the criterion standard; however, the evidence is limited for single blocks or dual blocks for relief of 50% to 74% and single blocks with at least 75% pain relief. Key words: Chronic neck pain, cervical facet or zygapophysial joint pain, cervical medial branch blocks, controlled comparative local anesthetic blocks

Background: Lumbar disc herniation and radiculitis are common elements of low back and lower extremity pain. Among minimally invasive treatments, epidural injections are one of the most commonly performed interventions. However, the literature is mixed about their effectiveness in managing low back and lower extremity pain. In general, individual studies and systematic reviews of epidural steroid injections have been hampered by their study design, baseline differences between treatment groups, inadequate sample sizes, highly controlled settings, lack of validated outcome measures, and the inability to confirm the injectate location because fluoroscopy was not used. Study Design: A randomized, controlled, double blind, active control trial. Setting: A private, interventional pain management practice, specialty referral center in the United States. Objectives: To assess the effectiveness of fluoroscopically directed caudal epidural injections with local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis. Methods: One hundred twenty patients were randomized to two groups: Group I received 10 mL caudal epidural injections of local anesthetic, lidocaine 0.5%; Group II patients received caudal epidural injections of 0.5% lidocaine, 9 mL, mixed with 1 mL of steroid. Outcome Assessment: Multiple outcome measures were utilized. The primary outcome measures were Numeric Rating Scale (NRS) and the Oswestry Disability Index 2.0 (ODI). Secondary outcome measures were employment status and opioid intake. Significant pain relief improvement was defined as 50% or more improvement in NRS and ODI scores. Results: In the successful category, 77% of Group I had significant pain relief of ≥ 50% and functional status improvement of ≥ 50% reduction in ODI scores; in Group II it was 76%, whereas overall it was 60% and 65% in Groups I and II. Over the two years, Group I had an average number of procedures of 5.5 ± 2.8; Group II was 5.3 ± 2.4. Even though there was no significant difference in overall relief between the two groups, the average relief for each procedure was superior for steroids. Limitations: Presumed limitations of this evaluation include lack of a placebo group. Conclusion: Caudal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis. The present evidence illustrates the potential superiority of steroids compared with local anesthetic at two year follow up based on average relief per procedure. Key words: Chronic low back pain, caudal epidural injections, disc herniation, radiculitis, lower extremity pain, local anesthetic, steroids

Over the past two decades, as the prevalence of chronic pain and health care costs have exploded, an opioid epidemic with adverse consequences has escalated. Efforts to increase opioid use and a campaign touting the alleged undertreatment of pain continue to be significant factors in the escalation. Many arguments in favor of opioids are based solely on traditions, expert opinion, practical experience and uncontrolled anecdotal observations. Over the past 20 years, the liberalization of laws governing the prescribing of opioids for the treatment of chronic non-cancer pain by the state medical boards has led to dramatic increases in opioid use. This has evolved into the present stage, with the introduction of new pain management standards by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) in 2000, an increased awareness of the right to pain relief, the support of various organizations supporting the use of opioids in large doses, and finally, aggressive marketing by the pharmaceutical industry. These positions are based on unsound science and blatant misinformation, and accompanied by the dangerous assumptions that opioids are highly effective and safe, and devoid of adverse events when prescribed by physicians. Results of the 2010 National Survey on Drug Use and Health (NSDUH) showed that an estimated 22.6 million, or 8.9% of Americans, aged 12 or older, were current or past month illicit drug users, The survey showed that just behind the 7 million people who had used marijuana, 5.1 million had used pain relievers. It has also been shown that only one in 6 or 17.3% of users of non-therapeutic opioids indicated that they received the drugs through a prescription from one doctor. The escalating use of therapeutic opioids shows hydrocodone topping all prescriptions with 136.7 million prescriptions in 2011, with all narcotic analgesics exceeding 238 million prescriptions. It has also been illustrated that opioid analgesics are now responsible for more deaths than the number of deaths from both suicide and motor vehicle crashes, or deaths from cocaine and heroin combined. A significant relationship exists between sales of opioid pain relievers and deaths. The majority of deaths (60%) occur in patients when they are given prescriptions based on prescribing guidelines by medical boards, with 20% of deaths in low dose opioid therapy of 100 mg of morphine equivalent dose or less per day and 40% in those receiving morphine of over 100 mg per day. In comparison, 40% of deaths occur in individuals abusing the drugs obtained through multiple prescriptions, doctor shopping, and drug diversion. The purpose of this comprehensive review is to describe various aspects of crisis of opioid use in the United States. The obstacles that must be surmounted are primarily inappropriate prescribing patterns, which are largely based on a lack of knowledge, perceived safety, and inaccurate belief of undertreatment of pain. Key words: Opioid abuse, opioid misuse, nonmedical use of psychotherapeutic drugs, nonmedical use of opioids, National Survey on Drug Use and Health, opioid guidelines.

The pain clinician is confronted with the formidable task of objectifying the subjective phenomenon of pain so as to determine the right treatments for both the pain syndrome and the patient in whom the pathology is expressed. However, the experience of pain — and its expression — remains enigmatic. Can currently available evaluative tools, questionnaires, and scales actually provide adequately objective information about the experiential dimensions of pain? Can, or will, current and future iterations of biotechnology — whether used singularly or in combination (with other technologies as well as observational-behavioral methods) — afford objective validation of pain? And what of the clinical, ethical, legal and social issues that arise in and from the use — and potential misuse — of these approaches? Subsequent trajectories of clinical care depend upon the findings gained through the use of these techniques and their inappropriate employment – or misinterpretation of the results they provide — can lead to misdiagnoses and incorrect treatment. This essay is the first of a two-part series that explicates how the intellectual tasks of knowing about pain and the assessment of its experience and expression in the pain patient are constituent to the moral responsibility of pain medicine. Herein, we discuss the problem of pain and its expression, and those methods, techniques, and technologies available to bridge the gap between subjective experience and objective evaluation. We address how these assessment approaches are fundamental to apprehend both pain as an objective, neurological event, and its impact upon the subjective experience, existence, and expectations of the person in pain. In this way, we argue that the right use of technology — together with inter-subjectivity, compassion, and insight — can sustain the good of pain care as both a therapeutic and moral enterprise. Key words: pain, assessment, neurotechnology, biotechnology, neuroethics, medicine

Background: Interventional techniques for the treatment of spinal techniques are commonly used and are increasing exponentially. Epidural injections and facet joint interventions are the 2 most commonly utilized procedures in interventional pain management. The current literature regarding the effectiveness of epidural injections is sparse with highly variable outcomes based on the technique, outcome measures, patient selection, and methodology. Multiple reports have illustrated the exponential growth of lumbosacral injections with significant geographic variations in the administration of epidural injections in Medicare patients. However, an analysis of the growth of epidural injections and costs in the Medicare population has not been performed with recent data and has not been looked at from an interventional pain management perspective. Study Design: Analysis of epidural injection growth and costs in Medicare’s population 1997, 2002, and 2006. Objectives: The primary purpose of this study was to evaluate the use of all types of epidural injections (i.e. caudal, interlaminar, and transforaminal in lumbar, cervical and thoracic regions), and other epidural procedures, including epidural adhesiolysis. In addition, the purpose was to identify trends in the number of procedures, reimbursement, specialty involvement, fluoroscopy use, and indications from 1997 to 2006. Methods: The Centers for Medicare and Medicaid Services (CMS) 5% national sample carrier claim record data from 1997, 2002, and 2006 was utilized. Outcomes Assessment: Outcome measures included Medicare beneficiaries’ characteristics receiving epidural injections, epidural injections by place of service, type of specialty, reimbursement characteristics, and other variables. Results: Epidural injections increased significantly in Medicare beneficiaries from 1997 to 2006. Patients receiving epidurals increased by 106.3%; visits per 100,000 population increased 102.7%. Hospital outpatient department (HOPD) payments increased significantly; ASC average payments decreased; overall payments increased. The increase in procedures performed by general physicians outpaced that of interventional pain management (IPM) physicians. Limitations: Study limitations include no Medicare Advantage patients; potential documentation, coding, and billing errors. Conclusions: Epidural injections grew significantly. This growth appears to coincide with chronic low back pain growth and other treatments for low back pain. Since many procedures are performed without fluoroscopy, continued growth and inappropriate provision of services might reduce access. Key words: Epidural injections, interventional techniques, interventional pain management, chronic pain, ambulatory surgery center (ASC), hospital outpatient department (HOPD)

The health care industry in general and care of chronic pain in particular are described as recessionproof. However, a perfect storm with a confluence of many factors and events —none of which alone is particularly devastating — is brewing and may create a catastrophic force, even in a small specialty such as interventional pain management. Multiple challenges related to interventional pain management in the current decade will include individual and group physicians, office practices, ambulatory surgery centers (ASCs), and hospital outpatient departments (HOPD). Rising health care costs are discussed on a daily basis in the United States. The critics have claimed that health outcomes are the same as or worse than those in other countries, but others have presented the evidence that the United States has the best health care system. All agree it is essential to reduce costs. Numerous factors contribute to increasing health care costs. They include administrative costs, waste, abuse, and fraud. It has been claimed the U.S. health care system wastes up to $800 billion a year. Of this, fraud accounts for approximately $200 billion a year, involving fraudulent Medicare claims, kickbacks for referrals for unnecessary services, and other scams. Administrative inefficiency and redundant paperwork accounts for 18% of health care waste, whereas medical mistakes account for $50 billion to $100 billion in unnecessary spending each year, or 11% of the total. Further, American physicians spend nearly 8 hours per week on paperwork and employ 1.66 clerical workers per doctor, more than any other country. It has been illustrated that it takes $60,000 to $88,000 per physician per year, equal to one-third of a family practitioner’s gross income, and $23 to $31 billion each year in total to interact with health insurance plans. The studies have illustrated that an average physician spends $68,274 per year communicating with insurance companies and performing other non-medical functions. For an office-based practice, the overall total in the United States is $38.7 billion, or $85,276 per physician. In the United States there are 2 types of physician payment systems: private health care and Medicare. Medicare has moved away from the Medicare Economic Index (MEI) and introduced the sustainable growth rate (SGR) formula which has led to cuts in physician payments on a yearly basis. In 2010 and beyond into the new decade, interventional pain management will see significant changes in how we practice medicine. There is focus on avoiding waste, abuse, fraud, and also cutting costs. Evidence-based medicine (EBM) and comparative effectiveness research (CER) have been introduced as cost-cutting and rationing measures, however, with biased approaches. This manuscript will analyze various issues related to interventional pain management with a critical analysis of physician payments, office facility payments, and ASC payments by various payor groups. Key words: Interventional pain management, interventional techniques, physician payment reform, ambulatory surgery center payment, hospital outpatient department payments, sustained growth rate formula, targeted growth rate formula, fraud, abuse, administrative expenses, evidence-based medicine, health care costs

The United States leads the world in many measures of health care innovation. However, it has been criticized to lag behind many developed nations in important health outcomes including mortality rates and higher health care costs. The surveys have shown the United States to outspend all other Organisation for Economic Co-operation and Development (OECD) countries with spending on health goods and services per person of $7,290 – almost 2½ times the average of all OECD countries in 2007. Rising health care costs in the United States have been estimated to increase to 19.1% of gross domestic product (GDP) or $4.4 trillion by 2018. CER is defined as the generation and synthesis of evidence that compares the benefits and harms of alternate methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The, comparative effectiveness research (CER) has been touted by supporters with high expectations to resolve most ill effects of health care in the United States providing high quality, less expensive, universal health care. The efforts of CER in the United States date back to the late 1970s and it was officially inaugurated with the enactment of the Medicare Modernization Act (MMA). It has been rejuvenated with the American Recovery and Reinvestment Act (ARRA) of 2009 with an allocation of $1.1 billion. CER has been the basis of decision for health care in many other countries. Of all the available agencies, the National Institute for Health and Clinical Excellence (NICE) of the United Kingdom is the most advanced, stable, and has provided significant evidence, though based on rigid and proscriptive economic and clinical formulas. While CER is taking a rapid surge in the United States, supporters and opponents are emerging expressing their views. Since interventional pain management is a new and evolving specialty, with ownership claimed by numerous organizations, at times it is felt as if it has many fathers and other times it becomes an orphan. Part 2 of this comprehensive review will provide facts, fallacies, and politics of CER along with discussion of potential outcomes, impact of CER on health care delivery, and implications for interventional pain management in the United States. Key words: Comparative effectiveness research, evidence-based medicine, Institute of Medicine, National Institute for Health and Clinical Excellence, interventional pain management, interventional techniques, geographic variations, inappropriate care.

While the United States leads the world in many measures of health care innovation, it has been suggested that it lags behind many developed nations in a variety of health outcomes. It has also been stated that the United States continues to outspend all other Organisation for Economic Co-operation and Development (OECD) countries by a wide margin. Spending on health goods and services per person in the United States, in 2007, increased to $7,290 – almost 2½ times the average of all OECD countries. Rising health care costs in the United States have been estimated to increase to 19.1% of gross domestic product (GDP) or $4.4 trillion by 2018. The increases are illustrated in both public and private sectors. Higher health care costs in the United States are implied from the variations in the medical care from area to area around the country, with almost 50% of medical care being not evidence-based, and finally as much as 30% of spending reflecting medical care of uncertain or questionable value. Thus, comparative effectiveness research (CER) has been touted by supporters with high expectations to resolve most ill effects of health care in the United States and provide high quality, less expensive, universal health care. CER is defined as the generation and synthesis of evidence that compares the benefits and harms of alternate methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The efforts of CER in the United States date back to the late 1970’s even though it was officially born with the Medicare Modernization Act (MMA) and has been rejuvenated with the American Recovery and Reinvestment Act (ARRA) of 2009 with an allocation of $1.1 billion. CER has been the basis for health care decision-making in many other countries. According to the International Network of Agencies for Health Technology Assessments (INAHTA), many industrialized countries have bodies that are charged with health technology assessments (HTAs) or comparative effectiveness studies. Of all the available agencies, the National Institute for Health and Clinical Excellence (NICE) of the United Kingdom is the most advanced, stable, and has provided significant evidence, though based on rigid and proscriptive economic and clinical formulas. While CER is making a rapid surge in the United States, supporters and opponents are expressing their views. Part I of this comprehensive review will describe facts, fallacies, and politics of CER with discussions to understand basic concepts of CER. Key words: Comparative effectiveness research, evidence-based medicine, Institute of Medicine, National Institute for Health and Clinical Excellence, interventional pain management, interventional techniques, geographic variations, inappropriate care.

Background: Available evidence documents a wide degree of variance in the definition and practice of interventional pain management. Objective: To provide evidence-based clinical practice guidelines for interventional techniques in the treatment of chronic spinal pain. Design: Best evidence synthesis. Methods: Strength of evidence was assessed by the U.S. Preventive Services Task Force (USPSTF) criteria utilizing 5 levels of evidence ranging from Level I to III with 3 subcategories in Level II. Outcomes: Short-term pain relief was defined as relief lasting 6 months or less and long-term relief as longer than 6 months, except ≤ one year and > one year for intradiscal therapies, mechanical disc decompression, spinal cord stimulation, and intrathecal infusion systems. Results: The indicated evidence for therapeutic interventions is Level I for caudal epidural steroid injections in managing disc herniation or radiculitis, and discogenic pain without disc herniation or radiculitis. The evidence is Level I to II-1 for percutaneous adhesiolysis in management of pain secondary to post-lumbar surgery syndrome. The evidence is Level II-1 or II-2 for therapeutic cervical, thoracic, and lumbar facet joint nerve blocks; for caudal epidural injections in managing pain of post-lumbar surgery syndrome, and lumbar spinal stenosis, for cervical interlaminar epidural injections in managing cervical pain (Level II-1); for lumbar transforaminal epidural injections; and spinal cord stimulation for post-lumbar surgery syndrome. Limitations: The limitations of this guideline preparation included a paucity of literature, lack of updates, and lack of conflicts in preparation of systematic reviews and guidelines by various organizations. Conclusion: The indicated evidence for therapeutic interventions is variable from Level I to III. This comprehensive review includes the evaluation of evidence for therapeutic procedures in managing chronic spinal pain and recommendations. However, this review and recommendations do not constitute inflexible treatment recommendations or “standard of care.” Key words: Interventional techniques, chronic spinal pain, therapeutic interventions, facet joint interventions, epidural procedures, epidural adhesiolysis, radiofrequency, mechanical disc decompression, spinal cord stimulation, intrathecal implantable systems

Ethical and legal considerations in pain management typically relate to 2 issues. The first refers to pain management as a human right. The second involves the nature of the patient-physician relationship as it relates to pain management. Although pain physicians often like to think of pain management as a human right, it remains difficult to support this position as a point of law or as a matter of ethics. Medical organizations generally do not define pain management as a specific duty of the physician, apart from the provision of competent medical care. To date, neither law nor ethics creates a duty of care outside of the traditional patient-physician relationship. Absent a universal duty, no universal right exists. Pursuing pain management as a fundamental human right, although laudable, may place the power of the government in the middle of the patient-physician relationship. Despite apparent altruistic motives, attempts to define pain management as a basic human right could have unintended consequences, such as nationalization of medicine to ensure provision of pain management for all patients. Key words: Ethics, law, patient-physician relationship, human right, pain management

Dr. Boswell is Professor and Chair, Dept of Anesthesiology, MesserRacz International Pain Center, Texas Tech University Health Sciences Center, Lubbock, TX. Dr. Giordano is Samueli-Rockefeller Professor, Dept of Medicine and Neurosciences, and Center for Bioethics, Georgetown University Medical Center, Washington, DC; and Senior Fellow and Director, Center for Neurotechnology Studies, Potomac Institute for Policy Studies, Arlington VA.