Cervical Nerve Root Block Using a Curved Blunt Needle and Posterior Approach.

BACKGROUND: Cervical transforaminal epidural steroid injections have become less popular due to the risk of catastrophic complications they pose. However, cervical nerve root blocks are useful for surgical planning in patients with cervical radicular pain syndromes. OBJECTIVES: Our aim was to find a method of performing cervical selective nerve root blocks that removed the risk of catastrophic complications. STUDY DESIGN: Retrospective case review. SETTING: Academic multidisciplinary spine center. METHODS: Among patients, 50 consecutive cases were retrospectively reviewed for immediate pain scores and follow-up results. In the intervention, a posterior approach using a curved blunt needle was employed for cervical selective nerve root blocks to minimize the risk of arterial injection. To measure the outcomes, we used quantitative pain severity scores and qualitative responses. RESULTS: This technique detailed in this study has a high immediate analgesic effect that can be used for diagnostic purposes. It is not known if this technique has prognostic value with respect to surgery. The prolonged response rate is about 50%, which is in line with other techniques. LIMITATIONS: This study had no control group. CONCLUSION(S): Cervical selective nerve root blocks using a curved blunt needle and a posterior approach are effective in selectively identifying nerves that cause clinical symptoms. This technique minimizes the risk of arterial or spinal cord impingement and therefore may be safer than transforaminal selective nerve root blocks.

Comprehensive, Evidence-Based, Consensus Guidelines for Prescription of Opioids for Chronic Non-Cancer Pain from the American Society of Interventional Pain Physicians (ASIPP).

BACKGROUND: Opioid prescribing in the United States is decreasing, however, the opioid epidemic is continuing at an uncontrollable rate. Available data show a significant number of opioid deaths, primarily associated with illicit fentanyl use. It is interesting to also note that the data show no clear correlation between opioid prescribing (either number of prescriptions or morphine milligram equivalent [MME] per capita), opioid hospitalizations, and deaths. Furthermore, the data suggest that the 2016 guidelines from the Centers for Disease Control and Prevention (CDC) have resulted in notable problems including increased hospitalizations and mental health disorders due to the lack of appropriate opioid prescribing as well as inaptly rapid tapering or weaning processes. Consequently, when examined in light of other policies and complications caused by COVID-19, a fourth wave of the opioid epidemic has been emerging. OBJECTIVES: In light of this, we herein seek to provide guidance for the prescription of opioids for the management of chronic non-cancer pain. These clinical practice guidelines are based upon a systematic review of both clinical and epidemiological evidence and have been developed by a panel of multidisciplinary experts assessing the quality of the evidence and the strength of recommendations and offer a clear explanation of logical relationships between various care options and health outcomes. METHODS: The methods utilized included the development of objectives and key questions for the various facets of opioid prescribing practice. Also utilized were employment of trustworthy standards, and appropriate disclosures of conflicts of interest(s). The literature pertaining to opioid use, abuse, effectiveness, and adverse consequences was reviewed. The recommendations were developed after the appropriate review of text and questions by a panel of multidisciplinary subject matter experts, who tabulated comments, incorporated changes, and developed focal responses to questions posed. The multidisciplinary panel finalized 20 guideline recommendations for prescription of opioids for chronic non-cancer pain. Summary of the results showed over 90% agreement for the final 20 recommendations with strong consensus. The consensus guidelines included 4 sections specific to opioid therapy with 1) ten recommendations particular to initial steps of opioid therapy; 2) five recommendations for assessment of effectiveness of opioid therapy; 3) three recommendations regarding monitoring adherence and side effects; and 4) two general, final phase recommendations. LIMITATIONS: There is a continued paucity of literature of long-term opioid therapy addressing chronic non-cancer pain. Further, significant biases exist in the preparation of guidelines, which has led to highly variable rules and regulations across various states. CONCLUSION: These guidelines were developed based upon a comprehensive review of the literature, consensus among expert panelists, and in alignment with patient preferences, and shared decision-making so as to improve the long-term pain relief and function in patients with chronic non-cancer pain. Consequently, it was concluded - and herein recommended - that chronic opioid therapy should be provided in low doses with appropriate adherence monitoring and understanding of adverse events only to those patients with a proven medical necessity, and who exhibit stable improvement in both pain relief and activities of daily function, either independently or in conjunction with other modalities of treatments.

Comprehensive, evidence-based, consensus guidelines for prescription of opioids for chronic non-cancer pain from the American Society of Interventional Pain Physicians (ASIPP)

Opioid prescribing in the United States is decreasing, however, the opioid epidemic is continuing at an uncontrollable rate. Available data show a significant number of opioid deaths, primarily associated with illicit fentanyl use. It is interesting to also note that the data show no clear correlation between opioid prescribing (either number of prescriptions or morphine milligram equivalent [MME] per capita), opioid hospitalizations, and deaths. Furthermore, the data suggest that the 2016 guidelines from the Centers for Disease Control and Prevention (CDC) have resulted in notable problems including increased hospitalizations and mental health disorders due to the lack of appropriate opioid prescribing as well as inaptly rapid tapering or weaning processes. Consequently, when examined in light of other policies and complications caused by COVID-19, a fourth wave of the opioid epidemic has been emerging. In light of this, we herein seek to provide guidance for the prescription of opioids for the management of chronic non-cancer pain. These clinical practice guidelines are based upon a systematic review of both clinical and epidemiological evidence and have been developed by a panel of multidisciplinary experts assessing the quality of the evidence and the strength of recommendations and offer a clear explanation of logical relationships between various care options and health outcomes. The methods utilized included the development of objectives and key questions for the various facets of opioid prescribing practice. Also utilized were employment of trustworthy standards, and appropriate disclosures of conflicts of interest(s). The literature pertaining to opioid use, abuse, effectiveness, and adverse consequences was reviewed. The recommendations were developed after the appropriate review of text and questions by a panel of multidisciplinary subject matter experts, who tabulated comments, incorporated changes, and developed focal responses to questions posed

Transforaminal Epidural Steroid Injections: A Systematic Review and Meta-Analysis of Efficacy and Safety.

BACKGROUND: Transforaminal epidural injections have been used since the late 1990s to treat lumbar radicular pain. They have been the subject of considerable attention, with varying conclusions from systematic reviews as to their efficacy. Transforaminal injections have been associated with rare but major complications. Further, the use of transforaminal injections has increased since the passage of the Affordable Care Act. Finally, with the SARS-CoV-2 pandemic, there has been heightened concern regarding the risk associated with steroid injections. OBJECTIVES: To evaluate and update the effectiveness of transforaminal injections for 4 indications: radicular pain; from spinal stenosis; from failed back surgery syndrome; and for axial low back pain; and to evaluate the safety of the procedure. STUDY DESIGN: A systematic review and meta-analysis of the efficacy of transforaminal injections. METHODS: The available literature on transforaminal injections was reviewed and the quality assessed. The level of evidence was classified on a 5-point scale based on the quality of evidence developed by the US Preventive Services Task Force (USPSTF) and modified by the American Society of Interventional Pain Physicians (ASIPP). Data sources included relevant literature from 1966 to April 2020, and manual searches of the bibliographies of known primary and review articles. Pain relief and functional improvement were the primary outcome measures. A minimum of 6 months pain relief follow-up was required. RESULTS: For this systematic review, 66 studies were identified. Eighteen randomized controlled trials met the inclusion criteria. No observational studies were included. Eleven randomized controlled trials dealt with various aspects of transforaminal injections for radicular pain owing to disc herniation. Based on these studies, there is Level 1 evidence supporting the use of transforaminal injections for radicular pain owing to disc herniation. A meta-analysis showed that at both 3 and 6 months, there was highly statistically significant improvement in both pain and function with both particulate and nonparticulate steroids. For radicular pain from central stenosis there is one moderate quality study, with Level IV evidence. For radicular pain caused by failed back surgery syndrome there is one moderate quality study, with Level IV evidence. For radicular pain from foraminal stenosis and for axial pain there is Level V evidence, opinion-based/consensus, supporting the use of transforaminal injections. Transforaminal injections are generally safe. However, they have been associated with major neurologic complications related to cord infarct. Causes other than intraluminal injection of particulates appear to be at play. The use of an infraneural approach and of blunt needles appear to offer the greatest patient safety. Because of concern over the role of particulate steroids, multiple other injectates have been evaluated, including nonparticulate steroids, tumor necrosis factor alpha (TNF-a) inhibitors, and local anesthetics without steroids. No injectate has been proven superior. If there is concern about immunosuppression because of risk of COVID-19 infection, either the lowest possible dose of steroid or no steroid should be used. LIMITATIONS: The study was limited by the paucity of literature for some indications. CONCLUSIONS: There is Level I evidence for the use of transforaminal injections for radicular pain from disc herniations.

Epidural Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Comprehensive Evidence-Based Guidelines.

BACKGROUND: Chronic spinal pain is the most prevalent chronic disease with employment of multiple modes of interventional techniques including epidural interventions. Multiple randomized controlled trials (RCTs), observational studies, systematic reviews, and guidelines have been published. The recent review of the utilization patterns and expenditures show that there has been a decline in utilization of epidural injections with decrease in inflation adjusted costs from 2009 to 2018. The American Society of Interventional Pain Physicians (ASIPP) published guidelines for interventional techniques in 2013, and guidelines for facet joint interventions in 2020. Consequently, these guidelines have been prepared to update previously existing guidelines. OBJECTIVE: To provide evidence-based guidance in performing therapeutic epidural procedures, including caudal, interlaminar in lumbar, cervical, and thoracic spinal regions, transforaminal in lumbar spine, and percutaneous adhesiolysis in the lumbar spine. METHODS: The methodology utilized included the development of objective and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of epidural interventions was viewed with best evidence synthesis of available literature and  recommendations were provided. RESULTS: In preparation of the guidelines, extensive literature review was performed. In addition to review of multiple manuscripts in reference to utilization, expenditures, anatomical and pathophysiological considerations, pharmacological and harmful effects of drugs and procedures, for evidence synthesis we have included 47 systematic reviews and 43 RCTs covering all epidural interventions to meet the objectives.The evidence recommendations are as follows: Disc herniation: Based on relevant, high-quality fluoroscopically guided epidural injections, with or without steroids, and results of previous systematic reviews, the evidence is Level I for caudal epidural injections, lumbar interlaminar epidural injections, lumbar transforaminal epidural injections, and cervical interlaminar epidural injections with strong recommendation for long-term effectiveness.The evidence for percutaneous adhesiolysis in managing disc herniation based on one high-quality, placebo-controlled RCT is Level II with moderate to strong recommendation for long-term improvement in patients nonresponsive to conservative management and fluoroscopically guided epidural injections. For thoracic disc herniation, based on one relevant, high-quality RCT of thoracic epidural with fluoroscopic guidance, with or without steroids, the evidence is Level II with moderate to strong recommendation for long-term effectiveness.Spinal stenosis: The evidence based on one high-quality RCT in each category the evidence is Level III to II for fluoroscopically guided caudal epidural injections with moderate to strong recommendation and Level II for fluoroscopically guided lumbar and cervical interlaminar epidural injections with moderate to strong recommendation for long-term effectiveness.The evidence for lumbar transforaminal epidural injections is Level IV to III with moderate recommendation with fluoroscopically guided lumbar transforaminal epidural injections for long-term improvement. The evidence for percutaneous adhesiolysis in lumbar stenosis based on relevant, moderate to high quality RCTs, observational studies, and systematic reviews is Level II with moderate to strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. Axial discogenic pain: The evidence for axial discogenic pain without facet joint pain or sacroiliac joint pain in the lumbar and cervical spine with fluoroscopically guided caudal, lumbar and cervical interlaminar epidural injections, based on one relevant high quality RCT in each category is Level II with moderate to strong recommendation for long-term improvement, with or without steroids. Post-surgery syndrome: The evidence for lumbar and cervical post-surgery syndrome based on one relevant, high-quality RCT with fluoroscopic guidance for caudal and cervical interlaminar epidural injections, with or without steroids, is Level II with moderate to strong recommendation for long-term improvement. For percutaneous adhesiolysis, based on multiple moderate to high-quality RCTs and systematic reviews, the evidence is Level I with strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. LIMITATIONS: The limitations of these guidelines include a continued paucity of high-quality studies for some techniques and various conditions including spinal stenosis, post-surgery syndrome, and discogenic pain. CONCLUSIONS: These epidural intervention guidelines including percutaneous adhesiolysis were prepared with a comprehensive review of the literature with methodologic quality assessment and determination of level of evidence with strength of recommendations.

Comprehensive Evidence-Based Guidelines for Facet Joint Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines Facet Joint Interventions 2020 Guidelines.

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.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. 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 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. KEY WORDS: Chronic spinal pain, interventional techniques, diagnostic blocks, therapeutic interventions, facet joint nerve blocks, intraarticular injections, radiofrequency neurolysis.

Comprehensive evidence-based guidelines for facet joint interventions in the management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) guidelines

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.

Hyaluronidase in Neuroplasty: A Review.

BACKGROUND: Neuroplasty, also known as percutaneous adhesiolysis, is an effective treatment for persistent axial and radicular pain. OBJECTIVES: One issue of concern is whether hyaluronidase should be used when performing neuroplasty. The objective of this narrative review is to evaluate the current literature relating to hyaluronidase and its role in neuroplasty. METHODS: The literature relating to hyaluronidase was examined via a search of PubMed and Google Scholar until April 2019, review of the citations of relevant literature, and the authors' knowledge of the literature and activity in the field. The literature was reviewed in light of hyaluronidase's physiologic role, allergenicity, medical uses, and evaluation specifically for neuroplasty. RESULTS: Hyaluronidase facilitates the spread of medications in the extracellular matrix by breaking down polysaccharides in the interstitial space. While allergic reactions to hyaluronidase have been reported, these reactions occurred with animal-derived preparations. The current human recombinant hyaluronidase does not have any reports of allergic reactions. Laboratory studies show that it does not evoke an immune response. Hyaluronidase has been extensively used in a variety of medical applications, including intrathecal treatment of arachnoiditis.There have been multiple studies reporting benefit from the use of hyaluronidase in interventional procedures. One randomized trial specifically looking at the use of hyaluronidase in neuroplasty found that the addition of hyaluronidase improved pain ratings at 12 months compared to other techniques and decreased the number of procedures needed to gain effect. LIMITATIONS: There have been limited studies examining the enhanced efficacy of neuroplasty when hyaluronidase is added. CONCLUSIONS: Because of enhanced efficacy and safety, and because of the decrease in the number of procedures needed to be performed, hyaluronidase should be considered when deciding which medications to use when performing neuroplasty. KEY WORDS: Neuroplasty, adhesiolysis, hyaluronidase, spinal stenosis, failed back surgery synderome, post lumbar surgery syndrome.

Effectiveness of Thermal Annular Procedures in Treating Discogenic Low Back Pain.

BACKGROUND: Discogenic low back is a distinct clinic entity characterized by pain arising from a damaged disc. The diagnosis is clouded by the controversy surrounding discography. The treatment options are limited, with unsatisfactory results from both conservative treatment and surgery. Multiple interventional therapies have been developed to treat discogenic pain, but most have not yet been validated by high quality studies.The best studied treatment for discogenic pain is the use of heat, which has been labeled as thermal intradiscal procedures (TIPs) by the Centers for Medicare and Medicaid Services (CMS). As the pathology is located in the annulus, we use the term thermal annular procedures (TAPs). OBJECTIVES: The aim of this study is to evaluate and update the efficacy of TAPs to treat chronic refractory discogenic pain. STUDY DESIGN: The design of this study is a systematic review. METHODS: The available literature on TAPs in treating chronic refractory discogenic pain was reviewed. The quality of each article used in this analysis was assessed.The level of evidence was classified on a 5-point scale from strong, based upon multiple randomized controlled trials (RCTs) to weak, based upon consensus, as developed by the US Preventive Services Task Force (USPSTF) and modified by the American Society of Interventional Pain Physicians (ASIPP).Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2015 and manual searches of the bibliographies of known primary and review articles.The primary outcome measures were pain relief and functional improvement of at least 40%. Short-term efficacy was defined as improvement for less than 6 months; long-term efficacy was defined as improvement for 6 months or more. RESULTS: For this systematic review, 49 studies were identified. Of these, there were 4 RCTs and no observational studies which met the inclusion criteria. Based upon 2 RCTs showing efficacy, with no negative trials, there is Level I, or strong, evidence of the efficacy of biacuplasty in the treatment of chronic, refractory discogenic pain.Based upon one high-quality RCT showing efficacy and one moderate-quality RCT interpreted as showing no benefit, there is Level III, or moderate, evidence supporting the use of intradiscal electrothermal therapy (IDET) in treating chronic, refractory discogenic pain.The evidence supporting the use of discTRODE is level V, or limited. CONCLUSION: The evidence is Level I, or strong, that percutaneous biacuplasty is efficacious in the treatment of chronic, refractory discogenic pain. Biacuplasty may be considered as a first-line treatment for chronic, refractory discogenic pain.The evidence is Level III, or moderate, that IDET is efficacious in the treatment of chronic, refractory discogenic pain.The evidence is Level V, or limited, that discTRODE is efficacious in the treatment of chronic, refractory discogenic pain.Key words: Spinal pain, chronic low back pain, intradiscal disorder, IDET, biacuplasty, discTRODE, thermal intradiscal disorders, thermal annular disorders.

Therapeutic Role of Placebo: Evolution of a New Paradigm in Understanding Research and Clinical Practice.

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.

Evolution of US Health Care Reform.

Major health policy creation or changes, including governmental and private policies affecting health care delivery are based on health care reform(s). Health care reform has been a global issue over the years and the United States has seen proposals for multiple reforms over the years. A successful, health care proposal in the United States with involvement of the federal government was the short-lived establishment of the first system of national medical care in the South. In the 20th century, the United States was influenced by progressivism leading to the initiation of efforts to achieve universal coverage, supported by a Republican presidential candidate, Theodore Roosevelt. In 1933, Franklin D. Roosevelt, a Democrat, included a publicly funded health care program while drafting provisions to Social Security legislation, which was eliminated from the final legislation. Subsequently, multiple proposals were introduced, starting in 1949 with President Harry S Truman who proposed universal health care; the proposal by Lyndon B. Johnson with Social Security Act in 1965 which created Medicare and Medicaid; proposals by Ted Kennedy and President Richard Nixon that promoted variations of universal health care. presidential candidate Jimmy Carter also proposed universal health care. This was followed by an effort by President Bill Clinton and headed by first lady Hillary Clinton in 1993, but was not enacted into law. Finally, the election of President Barack Obama and control of both houses of Congress by the Democrats led to the passage of the Affordable Care Act (ACA), often referred to as "ObamaCare" was signed into law in March 2010. Since then, the ACA, or Obamacare, has become a centerpiece of political campaigning. The Republicans now control the presidency and both houses of Congress and are attempting to repeal and replace the ACA. Key words: Health care reform, Affordable Care Act (ACA), Obamacare, Medicare, Medicaid, American Health Care Act.

A Critical Analysis of Obamacare: Affordable Care or Insurance for Many and Coverage for Few?

The Affordable Care Act (ACA), of 2010, or Obamacare, was the most monumental change in US health care policy since the passage of Medicaid and Medicare in 1965. Since its enactment, numerous claims have been made on both sides of the aisle regarding the ACA's success or failure; these views often colored by political persuasion. The ACA had 3 primary goals: increasing the number of the insured, improving the quality of care, and reducing the costs of health care. One point often lost in the discussion is the distinction between affordability and access. Health insurance is a financial mechanism for paying for health care, while access refers to the process of actually obtaining that health care. The ACA has widened the gap between providing patients the mechanism of paying for healthcare and actually receiving it. The ACA is applauded for increasing the number of insured, quite appropriately as that has occurred for over 20 million people. Less frequently mentioned are the 6 million who have lost their insurance. Further, in terms of how health insurance is been provided, the majority the expansion was based on Medicaid expansion, with an increase of 13 million. Consequently, the ACA hasn't worked well for the working and middle class who receive much less support, particularly those who earn more than 400% of the federal poverty level, who constitute 40% of the population and don't receive any help. As a result, exchange enrollment has been a disappointment and the percentage of workers obtaining their health benefits from their employer has decreased steadily. Access to health care has been uneven, with those on Medicaid hampered by narrow networks, while those on the exchanges or getting employer benefits have faced high out-of-pocket costs.The second category relates to cost containment. President Obama claimed that the ACA provided significant cost containment, in that costs would have been even much higher if the ACA was not enacted. Further, he attributed cost reductions generally to the ACA, not taking into account factors such as the recession, increased out-of-pocket costs, increasing drug prices, and reduced coverage by insurers.The final goal was improvement in quality. The effort to improve quality has led to the creation of dozens of new agencies, boards, commissions, and other government entities. In turn, practice management and regulatory compliance costs have increased. Structurally, solo and independent practices, which lack the capability to manage these new regulatory demands, have declined. Hospital employment, with its associated increased costs, has been soaring. Despite a focus on preventive services in the management of chronic disease, only 3% of health care expenditures have been spent on preventive services while the costs of managing chronic disease continue to escalate.The ACA is the most consequential and comprehensive health care reform enacted since Medicare. The ACA has gained a net increase in the number of individuals with insurance, primarily through Medicaid expansion. The reduction in costs is an arguable achievement, while quality of care has seemingly not improved. Finally, access seems to have diminished.This review attempts to bring clarity to the discussion by reviewing the ACA's impact on affordability, cost containment and quality of care. We will discuss these aspects of the ACA from the perspective of proponents, opponents, and a pragmatic point of view.Key words: Affordable Care Act (ACA), Obamacare, Medicare, Medicaid, Medicare Modernization Act (MMA), cost of health care, quality of health care, Merit-Based Incentive Payments System (MIPS).

Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines.

BACKGROUND: Opioid use, abuse, and adverse consequences, including death, have escalated at an alarming rate since the 1990s. In an attempt to control opioid abuse, numerous regulations and guidelines for responsible opioid prescribing have been developed by various organizations. However, the US opioid epidemic is continuing and drug dose deaths tripled during 1999 to 2015. Recent data show a continuing increase in deaths due to natural and semisynthetic opioids, a decline in methadone deaths, and an explosive increase in the rates of deaths involving other opioids, specifically heroin and illicit synthetic fentanyl. Contrary to scientific evidence of efficacy and negative recommendations, a significant proportion of physicians and patients (92%) believe that opioids reduce pain and a smaller proportion (57%) report better quality of life. In preparation of the current guidelines, we have focused on the means to reduce the abuse and diversion of opioids without jeopardizing access for those patients suffering from non-cancer pain who have an appropriate medical indication for opioid use. OBJECTIVES: To provide guidance for the prescription of opioids for the management of chronic non-cancer pain, to develop a consistent philosophy among the many diverse groups with an interest in opioid use as to how appropriately prescribe opioids, to improve the treatment of chronic non-cancer pain and to reduce the likelihood of drug abuse and diversion. These guidelines are intended to provide a systematic and standardized approach to this complex and difficult arena of practice, while recognizing that every clinical situation is unique. METHODS: The methodology utilized included the development of objectives and key questions. The methodology also utilized trustworthy standards, appropriate disclosures of conflicts of interest, as well as a panel of experts from various specialties and groups. The literature pertaining to opioid use, abuse, effectiveness, and adverse consequences was reviewed, with a best evidence synthesis of the available literature, and utilized grading for recommendation as described by the Agency for Healthcare Research and Quality (AHRQ).Summary of Recommendations:i. Initial Steps of Opioid Therapy 1. Comprehensive assessment and documentation. (Evidence: Level I; Strength of Recommendation: Strong) 2. Screening for opioid abuse to identify opioid abusers. (Evidence: Level II-III; Strength of Recommendation: Moderate) 3. Utilization of prescription drug monitoring programs (PDMPs). (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 4. Utilization of urine drug testing (UDT). (Evidence: Level II; Strength of Recommendation: Moderate) 5. Establish appropriate physical diagnosis and psychological diagnosis if available. (Evidence: Level I; Strength of Recommendation: Strong) 6. Consider appropriate imaging, physical diagnosis, and psychological status to collaborate with subjective complaints. (Evidence: Level III; Strength of Recommendation: Moderate) 7. Establish medical necessity based on average moderate to severe (≥ 4 on a scale of 0 - 10) pain and/or disability. (Evidence: Level II; Strength of Recommendation: Moderate) 8. Stratify patients based on risk. (Evidence: Level I-II; Strength of Recommendation: Moderate) 9. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. (Evidence: Level I-II; Strength of Recommendation: Moderate) 10. Obtain a robust opioid agreement, which is followed by all parties. (Evidence: Level III; Strength of Recommendation: Moderate)ii. Assessment of Effectiveness of Long-Term Opioid Therapy 11. Initiate opioid therapy with low dose, short-acting drugs, with appropriate monitoring. (Evidence: Level II; Strength of Recommendation: Moderate) 12. Consider up to 40 morphine milligram equivalent (MME) as low dose, 41 to 90 MME as a moderate dose, and greater than 91 MME as high dose. (Evidence: Level II; Strength of Recommendation: Moderate) 13. Avoid long-acting opioids for the initiation of opioid therapy. (Evidence: Level I; Strength of Recommendation: Strong) 14. Recommend methadone only for use after failure of other opioid therapy and only by clinicians with specific training in its risks and uses, within FDA recommended doses. (Evidence: Level I; Strength of Recommendation: Strong) 15. Understand and educate the patients of the effectiveness and adverse consequences. (Evidence: Level I; Strength of Recommendation: Strong) 16. Similar effectiveness for long-acting and short-acting opioids with increased adverse consequences of long-acting opioids. (Evidence: Level I-II; Strength of recommendation: Moderate to strong) 17. Periodically assess pain relief and/or functional status improvement of ≥ 30% without adverse consequences. (Evidence: Level II; Strength of recommendation: Moderate) 18. Recommend long-acting or high dose opioids only in specific circumstances with severe intractable pain. (Evidence: Level I; Strength of Recommendation: Strong)iii. Monitoring for Adherence and Side Effects 19. Monitor for adherence, abuse, and noncompliance by UDT and PDMPs. (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 20. Monitor patients on methadone with an electrocardiogram periodically. (Evidence: Level I; Strength of Recommendation: Strong). 21. Monitor for side effects including constipation and manage them appropriately, including discontinuation of opioids when indicated. (Evidence: Level I; Strength of Recommendation: Strong)iv. Final Phase 22. May continue with monitoring with continued medical necessity, with appropriate outcomes. (Evidence: Level I-II; Strength of Recommendation: Moderate) 23. Discontinue opioid therapy for lack of response, adverse consequences, and abuse with rehabilitation. (Evidence: Level III; Strength of Recommendation: Moderate) CONCLUSIONS: These guidelines were developed based on comprehensive review of the literature, consensus among the panelists, in consonance with patient preferences, shared decision-making, and practice patterns with limited evidence, based on randomized controlled trials (RCTs) to improve pain and function in chronic non-cancer pain on a long-term basis. Consequently, chronic opioid therapy should be provided only to patients with proven medical necessity and stability with improvement in pain and function, independently or in conjunction with other modalities of treatments in low doses with appropriate adherence monitoring and understanding of adverse events.Key words: Chronic pain, persistent pain, non-cancer pain, controlled substances, substance abuse, prescription drug abuse, dependency, opioids, prescription monitoring, drug testing, adherence monitoring, diversionDisclaimer: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."

Merit-Based Incentive Payment System: Meaningful Changes in the Final Rule Brings Cautious Optimism.

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) eliminated the flawed Sustainable Growth Rate (SGR) act formula - a longstanding crucial issue of concern for health care providers and Medicare beneficiaries. MACRA also included a quality improvement program entitled, "The Merit-Based Incentive Payment System, or MIPS." The proposed rule of MIPS sought to streamline existing federal quality efforts and therefore linked 4 distinct programs into one. Three existing programs, meaningful use (MU), Physician Quality Reporting System (PQRS), value-based payment (VBP) system were merged with the addition of Clinical Improvement Activity category. The proposed rule also changed the name of MU to Advancing Care Information, or ACI. ACI contributes to 25% of composite score of the four programs, PQRS contributes 50% of the composite score, while VBP system, which deals with resource use or cost, contributes to 10% of the composite score. The newest category, Improvement Activities or IA, contributes 15% to the composite score. The proposed rule also created what it called a design incentive that drives movement to delivery system reform principles with the inclusion of Advanced Alternative Payment Models (APMs).Following the release of the proposed rule, the medical community, as well as Congress, provided substantial input to Centers for Medicare and Medicaid Services (CMS),expressing their concern. American Society of Interventional Pain Physicians (ASIPP) focused on 3 important aspects: delay the implementation, provide a 3-month performance period, and provide ability to submit meaningful quality measures in a timely and economic manner. The final rule accepted many of the comments from various organizations, including several of those specifically emphasized by ASIPP, with acceptance of 3-month reporting period, as well as the ability to submit non-MIPS measures to improve real quality and make the system meaningful. CMS also provided a mechanism for physicians to avoid penalties for non-reporting with reporting of just a single patient. In summary, CMS has provided substantial flexibility with mechanisms to avoid penalties, reporting for 90 continuous days, increasing the low volume threshold, changing the reporting burden and data thresholds and, finally, coordination between performance categories. The final rule has made MIPS more meaningful with bonuses for exceptional performance, the ability to report for 90 days, and to report on 50% of the patients in 2017 and 60% of the patients in 2018. The final rule also reduced the quality measures to 6, including only one outcome or high priority measure with elimination of cross cutting measure requirement. In addition, the final rule reduced the burden of ACI, improved the coordination of performance, reduced improvement activities burden from 60 points to 40 points, and finally improved coordination between performance categories. Multiple concerns remain regarding the reduction in scoring for quality improvement in future years, increase in proportion of MIPS scoring for resource use utilizing flawed, claims based methodology and the continuation of the disproportionate importance of ACI, an expensive program that can be onerous for providers which in many ways has not lived up to its promise. Key words: Medicare Access and CHIP Reauthorization Act of 2015, merit-based incentive payment system, quality performance measures, resource use, improvement activities, advancing care information performance category.

Merit-Based Incentive Payment System (MIPS): Harsh Choices For Interventional Pain Management Physicians.

UNLABELLED: The Merit-based Incentive Payment System (MIPS) was created by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) to improve the health of all Americans by providing incentives and policies to improve patient health outcomes. MIPS combines 3 existing programs, Meaningful Use (MU), now called Advancing Care Information (ACI), contributing 25% of the composite score; Physician Quality Reporting System (PQRS), changed to Quality, contributing 50% of the composite score; and Value-based Payment (VBP) system to Resource Use or cost, contributing 10% of the composite score. Additionally, Clinical Practice Improvement Activities (CPIA), contributing 15% of the composite score, create multiple strategic goals to design incentives that drive movement toward delivery system reform principles with inclusion of Advanced Alternative Payment Models (APMs). Under the present proposal, the Centers for Medicare and Medicaid Services (CMS) has estimated approximately 30,000 to 90,000 providers from a total of over 761,000 providers will be exempt from MIPS. About 87% of solo practitioners and 70% of practitioners in groups of less than 10 will be subjected to negative payments or penalties ranging from 4% to 9%. In addition, MIPS also will affect a provider's reputation by making performance measures accessible to consumers and third-party physician rating Web sites.The MIPS composite performance scoring method, at least in theory, utilizes weights for each performance category, exceptional performance factors to earn bonuses, and incorporates the special circumstances of small practices.In conclusion, MIPS has the potential to affect practitioners negatively. Interventional Pain Medicine practitioners must understand the various MIPS measures and how they might participate in order to secure a brighter future. KEY WORDS: Medicare Access and CHIP Reauthorization Act of 2015, merit-based incentive payment system, quality performance measures, resource use, clinical practice improvement activities, advancing care information performance category.

First, do no harm by adopting evidence-based policy initiatives: the overselling of ICD-10 by congress with high expectations.

While it appears to be beneficial to apply a detailed disease classification system, the costs, cash flow disruptions, and increased investments with physician time incorporated into learning these processes, patient care might unfortunately suffer. This is essentially an unfunded mandate with much of the burden of transitioning to ICD-10 falling on health care providers,especially small independent practices. This will impact interventional pain management practices substantially.Further, as we have shown in previous manuscripts,the so-called advantages of multiple codes with specificity and granularity does not translate into reality where some specificity is actually lost for various codes. As Grimsley and O'Shea (1) have described in clinical practices, doctors do not treat codes, but they treat patients according to the individual clinical condition.A doctor will be losing valuable time and also will not be able to obtain meaningful information due to burdensome regulations of meaningful use, PQRS,value-based reimbursement, electronic prescribing,and now a major impact with change to ICD-10. Thus,very little benefit will be seen by practitioners, which cannot be said for the health care information industry.With overwhelming regulatory atmosphere created by numerous federal regulations and those including under the Affordable Care Act (15), there is no evidence that ICD-10 is needed, there is no evidence that it will be effective, and, finally, there is preponderance of evidence of adverse consequences. Thus, Congress should be cautious in imposing further regulations on already strained independent practices with ongoing regulations and imposing yet another unfunded mandate on the medical profession.

Percutaneous adhesiolysis procedures in the medicare population: analysis of utilization and growth patterns from 2000 to 2011.

BACKGROUND: Multiple reviews have shown that interventional techniques for chronic pain have increased dramatically over the years. Of these interventional techniques, both sacroiliac joint injections and facet joint interventions showed explosive growth, followed by epidural procedures. Percutaneous adhesiolysis procedures have not been assessed for their utilization patterns separately from epidural injections. STUDY DESIGN: An analysis of the utilization patterns of percutaneous adhesiolysis procedures in managing chronic low back pain in the Medicare population from 2000 to 2011. OBJECTIVE: To assess the utilization and growth patterns of percutaneous adhesiolysis in managing chronic low back pain. METHODS: The study was performed utilizing the Centers for Medicare and Medicaid Services (CMS) Physician Supplier Procedure Summary Master of Fee-For-Service (FFS) Data from 2000 to 2011. RESULTS: Percutaneous adhesiolysis procedures increased 47% with an annual growth rate of 3.6% in the FFS Medicare population from 2000 to 2011. These growth rates are significantly lower than the growth rates for sacroiliac joint injections (331%), facet joint interventions (308%), and epidural injections (130%), but substantially lower than lumbar transforaminal injections (665%) and lumbar facet joint neurolysis (544%). LIMITATIONS: Study limitations include lack of inclusion of Medicare Advantage patients. In addition, the statewide data is based on claims which may include the contiguous or other states. CONCLUSION: Percutaneous adhesiolysis utilization increased moderately in Medicare beneficiaries from 2000 to 2011. Overall, there was an increase of 47% in the utilization of adhesiolysis procedures per 100,000 Medicare beneficiaries, with an annual geometric average increase of 3.6%.

Accountable interventional pain management: a collaboration among practitioners, patients, payers, and government.

The prevalence, costs, and disability associated with chronic pain continue to escalate. So too, the numerous modalities of treatments applied in managing these patients continue to increase as well. In the period from 2000 to 2011 interventional techniques increased 228%. In addition, analysis of utilization trends and expenditures for spinal interventional techniques alone from 2000 to 2008 illustrated an increase in Medicare fee-for-service expenditures of 240% in terms of dollars spent in the United States. The Office of Inspector General (OIG) of the Department of Health and Human Services showed an increase in facet joint and transforaminal epidural injections, with a significant proportion of these services did not meet the medical necessity criteria.The increasing utilization of interventional techniques is also associated with significant variations among specialty groups and regional variations among states. Overall procedures have increased by 173%, with rate of 130% per 100,000 Medicare beneficiaries for epidural injections; 383%, with a rate of 308% for facet joint interventions; and overall 410%, or a rate of 331% for sacroiliac joint interventions. Certain high volume interventions such as lumbar transforaminal epidural injections and lumbar facet joint neurolysis have actually increased a staggering 806% and 662%.Coverage policies across ambulatory settings and by multiple payers are highly variable. Apart from variability in the development of coverage policies, payments also substantially vary by site of service. In general, amongst the various ambulatory settings the highest payments are made to hospital outpatient departments (HOPDs)  the lowest to in-office procedures, and payment to ambulatory surgery centers (ASCs) falling somewhere in the middle.This manuscript describes the many differences that exist between the various settings, and includes suggestions for accountable interventional pain management with coverage for techniques with evidence, addressing excessive use of specific techniques, and equalizing payments across multiple ambulatory settings.