scholarly journals Preoperative Fasting Before Interventional Techniques: Is It Necessary or Evidence-Based?

2011 ◽  
Vol 5;14 (5;9) ◽  
pp. 459-467
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Pain Management ◽  
Respiratory Depression ◽  
Postoperative Nausea ◽  
Management Practice ◽  
The United States ◽  
Nausea And Vomiting ◽  
Evidence Based ◽  
Preoperative Fasting ◽  
Interventional Techniques ◽  
Interventional Pain Management

Background: Interventional pain management is an evolving specialty. Multiple issues including preoperative fasting, sedation, and infection control have not been well investigated and addressed. Based on the necessity for sedation and also the adverse events related to interventional techniques, preoperative fasting is considered practical to avoid postoperative nausea and vomiting. However, there are no guidelines for interventional techniques for sedation or fasting. Most interventional techniques are performed under intravenous or conscious sedation. Objective: To assess the need for preoperative fasting and risks without fasting in patients undergoing interventional techniques. Study Design: A prospective, non-randomized study of patients undergoing interventional techniques from May 2008 to December 2009. Study Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Methods: All patients presenting for interventional techniques from May 2008 to December 2009 are included with documentation of various complications related to interventional techniques including nausea and vomiting. Results: From May 2008 to December 2009 a total of 3,179 patients underwent 12,000 encounters with 18,472 procedures, with patients receiving sedation during 11,856 encounters. Only 189, or 1.6% of the patients complained of nausea and 3 of them, or 0.02%, experienced vomiting. There were no aspirations. Of the 189 patients with nausea, 80 of them improved significantly prior to discharge without further complaints. Overall, 109 patients, or 0.9% were minimally nauseated prior to discharge. The postoperative complaints of continued nausea were reported in only 26 patients for 6 to 72 hours. There were only 2 events of respiratory depression, which were managed with brief oxygenation with mask without any adverse consequence of nausea, vomiting, aspiration, or other adverse effects. Limitations: Limitations include the nonrandomized observational nature of the study. Conclusion: This study illustrates that postoperative nausea, vomiting, and respiratory depression are extremely rare and aspiration is almost nonexistent, despite almost all of the patients receiving sedation and without preoperative fasting prior to provision of the interventional techniques. Key words: Interventional pain management, interventional techniques, complications, relative risk, evidence-based medicine, preoperative fasting, nausea, vomiting, aspiration

scholarly journals Ambulatory Surgery Centers and Interventional Techniques: A Look at Long-Term Survival

2011 ◽  
Vol 3;14 (2;3) ◽  
pp. E177-E212 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Health Care ◽  
Pain Management ◽  
Ambulatory Surgery ◽  
Health Care Expenditures ◽  
The United States ◽  
Payment System ◽  
Ambulatory Surgery Centers ◽  
Interventional Techniques ◽  
Outpatient Procedures ◽  
Interventional Pain Management

With health care expenditures skyrocketing, coupled with pervasive quality deficits, pressures to provide better and more proficient care continue to shape the landscape of the U.S. health care system. Payers, both federal and private, have laid out several initiatives designed to curtail costs, including value-based reimbursement programs, cost-shifting expenses to the consumer, reducing reimbursements for physicians, steering health care to more efficient settings, and finally affordable health care reform. Consequently, one of the major aspects in the expansion of health care for improving quality and reducing costs is surgical services. Nearly 57 million outpatient procedures are performed annually in the United States, 14 million of which occur in elderly patients. Increasing use of these minor, yet common, procedures contributes to rising health care expenditures. Once exclusive within hospitals, more and more outpatient procedures are being performed in freestanding ambulatory surgery centers (ASCs), physician offices, visits to which have increased over 300% during the past decade. Concurrent with this growing demand, the number of ASCs has more than doubled since the 1990s, with more than 5,000 facilities currently in operation nationwide. Further, total surgical center ASC payments have increased from $1.2 billion in 1999 to $3.2 billion in 2009, a 167% increase. On the same lines, growth and expenditures for hospital outpatient department (HOPD) services and office procedures also have been evident at similar levels. Recent surveys have illustrated on overall annual growth per capita in Medicare allowed ASC services of pain management of 23%, with 27% growth seen in ASCs and 16% of the growth seen in HOPD. Further, the proportion of interventional pain management which was 4% of Medicare ASC spending in 2000 has increased to 10% in 2007. Thus, interventional pain management as an evolving specialty is one of the most commonly performed procedures in ASC settings apart from HOPDs and well-equipped offices. In June 1998, the Health Care Financing Administration (HCFA) proposed an ASC rule in which at least 60% of interventional procedures were eliminated from ASCs, and the remaining 40% faced substantial cuts in payments. Following the publication of this rule, based on public comments and demand, Congress intervened and delayed implementation of the rule for several years. The Centers for Medicare and Medicaid Services (CMS) published its proposed outpatient prospective system for ASCs in 2006, setting ASC payments at 62% of HOPD payments. Following multiple changes, the rule was incorporated with a 4-year transition formula which ended in 2010, with full effect occurring in 2011 with ASCs reimbursed at 57% of HOPD payments. Thus, the landscape of interventional pain management in ambulatory surgery centers has been constantly changing with declining reimbursements, issues of fraud and abuse, and ever-increasing regulations. Key words: Outpatient prospective payment system, ambulatory surgery center payment system, Government Accountability Office, Medicare Modernization and Improvement Act, interventional techniques

scholarly journals Accountable Interventional Pain Management: A Collaboration Among Practitioners, Patients, Payers, and Government

2013 ◽  
Vol 6;16 (6;11) ◽  
pp. E635-E670
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Pain Management ◽  
Sacroiliac Joint ◽  
Facet Joint ◽  
Significant Proportion ◽  
The United States ◽  
Fee For Service ◽  
Interventional Techniques ◽  
Epidural Injections ◽  
Interventional Pain Management ◽  
Facet Joint Interventions

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. Key words: Accountable interventional pain management, Medicare, Medicare Evidence Development & Coverage Advisory Committee, epidural injections, facet joint interventions, sacroiliac joint injections, payment policies

scholarly journals Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management, Part I: Introduction and General Considerations

2008 ◽  
Vol 2;11 (3;2) ◽  
pp. 161-186
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Health Care ◽  
Pain Management ◽  
Systematic Reviews ◽  
Evidence Based Medicine ◽  
Critical Appraisal ◽  
Evidence Based Practice ◽  
The United States ◽  
Evidence Based ◽  
Interventional Pain Management ◽  
Based Medicine

Evidence-based medicine, systematic reviews, and guidelines are part of modern interventional pain management. As in other specialties in the United States, evidence-based medicine appears to motivate the search for answers to numerous questions related to costs and quality of health care as well as access to care. Scientific, relevant evidence is essential in clinical care, policy-making, dispute resolution, and law. Consequently, evidence based practice brings together pertinent, trustworthy information by systematically acquiring, analyzing, and transferring research findings into clinical, management, and policy arenas. In the United States, researchers, clinicians, professional organizations, and government are looking for a sensible approach to health care with practical evidence-based medicine. All modes of evidence-based practice, either in the form of evidence-based medicine, systematic reviews, meta-analysis, or guidelines, evolve through a methodological, rational accumulation, analysis, and understanding of the evidentiary knowledge that can be applied in clinical settings. Historically, evidence-based medicine is traceable to the 1700s, even though it was not explicitly defined and advanced until the late 1970s and early 1980s. Evidence-based medicine was initially called “critical appraisal” to describe the application of basic rules of evidence as they evolve into application in daily practices. Evidence-based medicine is defined as a conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. Evidence-based practice is defined based on 4 basic and important contingencies, which include recognition of the patient’s problem and construction of a structured clinical question, thorough search of medical literature to retrieve the best available evidence to answer the question, critical appraisal of all available evidence, and integration of the evidence with all aspects and contexts of the clinical circumstances. Systematic reviews provide the application of scientific strategies that limit bias by the systematic assembly, critical appraisal, and synthesis of all relevant studies on a specific topic. While systematic reviews are close to meta-analysis, they are vastly different from narrative reviews and health technology assessments. Clinical practice guidelines are systematically developed statements that aim to help physicians and patients reach the best health care decisions. Appropriately developed guidelines incorporate validity, reliability, reproducibility, clinical applicability and flexibility, clarity, development through a multidisciplinary process, scheduled reviews, and documentation. Thus, evidence-based clinical practice guidelines represent statements developed to improve the quality of care, patient access, treatment outcomes, appropriateness of care, efficiency and effectiveness and achieve cost containment by improving the cost benefit ratio. Part 1 of this series in evidence-based medicine, systematic reviews, and guidelines in interventional pain management provides an introduction and general considerations of these 3 aspects in interventional pain management. Key words: Evidence-based medicine, systematic reviews, clinical guidelines, narrative reviews, health technology assessments, grading of evidence, recommendations, grading systems, strength of evidence.

scholarly journals A Perfect Storm in Interventional Pain Management: Regulated, but Unbalanced

2010 ◽  
Vol 2;13 (1;2) ◽  
pp. 109-116
Author(s):  
Ramsin M. Benyamin
Keyword(s):  
Health Care ◽  
Pain Management ◽  
Evidence Based Medicine ◽  
Evidence Based ◽  
Interventional Techniques ◽  
Research Bias ◽  
Interventional Pain Management ◽  
Based Medicine ◽  
The Impact ◽  
Perfect Storm

Interventional pain management now stands at the crossroads at what is described as “the perfect storm.” The confluence of several factors has led to devastating results for interventional pain management. This article seeks to provide a perspective to various issues producing conditions conducive to creating a “perfect storm” such as use and abuse of interventional pain management techniques, and in the same context, use and abuse of various non-interventional techniques. The rapid increase in opioid drug prescribing, costs to health care, large increases in death rates, and random and rampant drug testing, can also lead to increases in health care utilization. Other important aspects that are seldom discussed include medico-legal and ethical perspectives of individual and professional societal opinions and the interpretation of diagnostic accuracy of controlled diagnostic blocks. The aim of this article is to discuss the impact of several factors on interventional pain management and overuse, abuse, waste, and fraud; inappropriate application without evidence-based literature support (sometimes leading to selective use or non-use of randomized or observational studies for proving biased viewpoints — post priori rather than a priori), and issues related to multiple professional societies having their own agendas to push rather than promulgating the science of interventional pain management. This perspective is based on a review of articles published in this issue of Pain Physician, information in the public domain, and other relevant articles. Based on the results of this review, various issues of relevance to modern interventional pain management are discussed and the viewpoints of several experts debated. In conclusion, supporters of interventional pain management disagree on multiple aspects for various reasons while detractors claim that interventional pain management should not exist as a speciality. Issues to be addressed include appropriate use of evidence-based medicine (EBM), overuse, overutilization, and abuse. Key words: Interventional pain management, interventional techniques, physician payment reform, fraud, abuse, evidence-based medicine, health care costs, comparative effectiveness research, bias

Increasing deaths from opioid analgesics in the United States: An evaluation in an interventional pain management practice

2018 ◽  
Vol 4 (5) ◽  
pp. 271 ◽  
Author(s):  
Kavita N. Manchikanti, BA ◽  
Laxmaiah Manchikanti, MD ◽  
Kimberly S. Damron, RN ◽  
Vidyasagar Pampati, MSc ◽  
Bert Fellows, MA
Keyword(s):  
Pain Management ◽  
Prescription Drugs ◽  
Management Practice ◽  
Opioid Analgesics ◽  
The United States ◽  
Tertiary Referral ◽  
Tertiary Referral Center ◽  
Total Prevalence ◽  
Interventional Pain Management ◽  
Poisoning Deaths

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

scholarly journals Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 5. Diagnostic Accuracy Studies

2009 ◽  
Vol 3;12 (3;5) ◽  
pp. 517-540
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Pain Management ◽  
Diagnostic Accuracy ◽  
Diagnostic Test ◽  
Systematic Reviews ◽  
Evidence Based Medicine ◽  
Diagnostic Tests ◽  
Evidence Based ◽  
Interventional Techniques ◽  
Interventional Pain Management ◽  
Based Medicine

Diagnosis is a critical component of health care. The world of diagnostic tests is highly dynamic. New tests are developed at a fast pace and technology of existing tests is continuously being improved. However, clinicians, policy makers, and patients routinely face a range of questions regarding diagnostic tests. Well designed diagnostic test accuracy studies can help in making these decisions, provided that they transparently and fully report their participants, tests, methods, and results (as facilitated). For example, by the standards for the reporting of diagnostic accuracy studies (STARD) statement. Exaggerated and biased results from poorly designed and reported diagnostic test studies can trigger their premature dissemination and lead physicians into making incorrect treatment decisions. Thus, a diagnostic test is useful only to the extent that it distinguishes between conditions or disorders that might otherwise be confused. While almost any test can differentiate healthy persons from severely affected ones, appropriate diagnostic tests should differentiate mild and moderate forms of disease. Shortcomings in a study design and interpretation can affect estimates of diagnostic accuracy. Thus, quality diagnostic studies are essential in medicine in general and interventional pain management in particular. The STARD initiative was developed to improve the accuracy and completeness in the reporting of studies of diagnostic accuracy and provide guidance to assist in reducing the potential for bias in the study and to evaluate a study’s generalizability. In the practice of interventional pain management, in addition to diagnostic tests which include laboratory tests, imaging tests, and physical examination, diagnostic interventional techniques are crucial. Interventional techniques as a diagnostic tool in painful conditions is important due to multiple challenging clinical situations, which include the purely subjective nature of pain and underdetermined and uncertain pathophysiology in most painful spinal conditions. Precision diagnostic blocks are used to clarify these challenging clinical situations in order to determine the pathophysiology of clinical pain, the site of nociception, and the pathway of afferent neural signals. Part 5 of evidence-based medicine (EBM) in interventional pain management describes the various aspects of diagnostic accuracy studies. Key words: Evidence-based medicine, diagnostic studies, systematic reviews, randomized trials, interventional pain management, standards for the reporting of diagnostic accuracy studies (STARD)

scholarly journals Interventional Techniques in Ambulatory Surgical Centers: A Look at the New Payment System

2007 ◽  
Vol 5;10 (9;5) ◽  
pp. 627-650
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Pain Management ◽  
Prospective Payment System ◽  
The United States ◽  
Payment System ◽  
Government Accountability ◽  
Interventional Techniques ◽  
Statutory Authority ◽  
Transition Formula ◽  
Management Procedures ◽  
Interventional Pain Management

There has been an explosive increase in procedures performed in surgery centers, with approximately 4,700 Medicare-certified surgery centers in the United States. Total ambulatory surgical center (ASC) payments have increased substantially: $1 billion in 1996, and $2.9 billion in 2006. In June 1998, the Healthcare Financing Administration (HCFA; CMS), proposed an ASC rule in which at least 60% of interventional procedures were eliminated from ASCs and the remaining 40% faced substantial cuts in payments. Following the publication of this rule, based on public comments and demand, Congress intervened and delayed implementation of the rule for several years. The Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) granted broad statutory authority to the Secretary of Health and Human Services to design a new ASC payment system based on the hospital outpatient payment system. The Centers for Medicare and Medicaid (CMS) published its proposed outpatient prospective system for ASCs in 2006, setting ASC payments at 62% of HOPD payments. This rule faced substantial opposition from providers, patients, and Congress. Consequently, CMS revised the rule with a 4-year transition formula to provide ASCs with 65% of HOPD payments. Based on the new proposed rule, most interventional pain management procedures in ASCs will lose approximately 3% to 5% without taking into account that there have not been any increments since 2004, except for a few small increases for some procedures, along with the addition of office procedures, which can now be performed in an ASC setting. However, payments for procedures moved from the office setting to ASCs remain at the lower office rates, which face substantial cuts on their own. The proposed CMS rule will have widespread effects on physician payments, ASC payments, and particularly interventional pain management physicians. Key words: Outpatient prospective payment system, ambulatory surgery center payment system, Government Accountability Office, Medicare Modernization and Improvement Act, interventional techniques

scholarly journals Variations in Interlaminar Epidural Steroid Injection Practice Patterns by Interventional Pain Management Physicians in the United States

2018 ◽  
Vol 1 (21;1) ◽  
pp. E493-E499 ◽  
Author(s):  
Lisa Doan
Keyword(s):  
United States ◽  
Pain Management ◽  
Image Guidance ◽  
Practice Patterns ◽  
Steroid Injection ◽  
The United States ◽  
Needle Size ◽  
Interventional Pain Management ◽  
Interlaminar Epidural Steroid Injection ◽  
Epidural Steroid

Background: Previous surveys have identified variations in practice patterns related to epidural steroid injections. Since then, the United States Food and Drug Administration (FDA) has required the addition of drug warning labels for injectable corticosteroids. Updated evidence, as well as scrutiny from regulatory agencies, may affect practice patterns. Objective: To provide an update on interlaminar epidural steroid injection (ILESI) practice patterns, we surveyed interventional pain management (IPM) physicians in the United States. Study Design and Setting: This was a cross-sectional survey of IPM physicians in the United States. Methods: A web-based survey was distributed to IPM physicians in the United States selected from the Accreditation Council for Graduate Medical Education accredited pain medicine fellowship program list as well as the American Society of Interventional Pain Physicians membership database. Physicians were queried about ILESI practices, including needle size, use of image guidance, level of injection, identification of the epidural space, and preference for injectate. Results: A total of 249 responses were analyzed. All respondents used image guidance for ILESI. There were variations in needle size, use of contrast, number of fluoroscopic views utilized, technique for identifying the epidural space, and choice of injectate. Limitations: The response rate is a limitation, thus the results may not be representative of all United States IPM physicians. Conclusions: Though all respondents used image guidance for ILESI, variations in other ILESI practices still exist. Since the closure of this survey, a multi-society pain workgroup published recommendations regarding ESI practices. Our survey findings support the need for more evidencebased guidelines regarding ESI. Key words: Epidural injection, epidural steroids, survey, low back pain, neck pain, technique

scholarly journals Reassessment of Evidence Synthesis of Occupational Medicine Practice Guidelines for Interventional Pain Management

2008 ◽  
Vol 4;11 (8;4) ◽  
pp. 393-482
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Chronic Pain ◽  
Pain Management ◽  
Strong Evidence ◽  
Guideline Development ◽  
Medial Branch ◽  
Low Back ◽  
Quality Of Evidence ◽  
Interventional Techniques ◽  
Interventional Pain Management

Background: Appropriately developed practice guidelines present statements of best practice based on a thorough evaluation of the evidence from published studies on the outcomes of treatments, which include the application of multiple methods for collecting and evaluating evidence for a wide range of clinical interventions and disciplines. However, the guidelines are neither infallible, nor a substitute for clinical judgment. While the guideline development process is a complex phenomenon, conflict of interest in guideline development and inappropriate methodologies must be avoided. It has been alleged that the guidelines by the American College of Occupational and Environmental Medicine (ACOEM) prevent injured workers from receiving the majority of medically necessary and appropriate interventional pain management services. An independent critical appraisal of both chapters of the ACOEM guidelines showed startling findings with a conclusion that these guidelines may not be applied in patient care as they scored below 30% in the majority of evaluations utilizing multiple standardized criteria. Objective: To reassess the evidence synthesis for the ACOEM guidelines for the low back pain and chronic pain chapters utilizing an expanded methodology, which includes the criteria included in the ACOEM guidelines with the addition of omitted literature and application of appropriate criteria. Methods: For reassessment, randomized trials were utilized as it was in the preparation of the guidelines. In this process, quality of evidence was assessed and recommendations were made based on grading recommendations of Guyatt et al. The level of evidence was determined utilizing the quality of evidence criteria developed by the U.S. Preventive Services Task Force (USPSTF), as well as the outdated quality of evidence criteria utilized by ACOEM in the guideline preparation. Methodologic quality of each individual article was assessed utilizing the Agency for Healthcare Research and Quality (AHRQ) methodologic assessment criteria for diagnostic interventions and Cochrane methodologic quality assessment criteria for therapeutic interventions. Results: The results of reassessment are vastly different from the conclusions derived by the ACOEM guidelines. The differences in strength of rating for the diagnosis of discogenic pain by provocation discography and facet joint pain by diagnostic facet joint nerve blocks is established with strong evidence. Therapeutic cervical and lumbar medial branch blocks and radiofrequency neurolysis, therapeutic thoracic medial branch blocks, cervical interlaminar epidural steroid injections, caudal epidural steroid injections, lumbar transforaminal epidural injections, percutaneous and endoscopic adhesiolysis, and spinal cord stimulation qualified for moderate to strong evidence. Additional insight is also provided for evidence rating for intradiscal electrothermal therapy (IDET), automated percutaneous disc decompression, and intrathecal implantables. Conclusion: The reassessment and reevaluation of the low back and chronic pain chapters of the ACOEM guidelines present results that are vastly different from the published and proposed guidelines. Contrary to ACOEM’s conclusions of insufficient evidence for most interventional techniques, the results illustrate moderate to strong evidence for most diagnostic and therapeutic interventional techniques. Key words: Guidelines, evidence-based medicine, systematic reviews, ACOEM, interventional pain management, interventional techniques, guideline development, workers’ compensation, chronic pain guidelines, low back pain guidelines

scholarly journals Value-Based Interventional Pain Management: A Review of Medicare National and Local Coverage Determination Policies

2013 ◽  
Vol 3;16 (3;5) ◽  
pp. E145-E180 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Pain Management ◽  
Randomized Clinical Trials ◽  
Medical Community ◽  
Final Decision ◽  
Evidence Based ◽  
Level Of Evidence ◽  
General Acceptance ◽  
Medical Needs ◽  
Medicare Coverage ◽  
Interventional Pain Management

Major policies, regulations, and practice patterns related to interventional pain management are dependent on Medicare policies which include national coverage policies – national coverage determinations (NCDs), and local coverage policies – local coverage determinations (LCDs). The NCDs are Medicare coverage policies issued by the Centers for Medicare and Medicaid Services (CMS). The process used by the CMS in deciding what is and what is not medically necessary is lengthy, involving a review of evidence-based literature on the subject, expert opinion, and public comments. In contrast, LCDs are rules and Medicare coverage that are issued by regional contractors and fiscal intermediaries when an NCD has not addressed the policy at issue. The evidence utilized in preparing LCDs includes the highest level of evidence which is based on published authoritative evidence derived from definitive randomized clinical trials or other definitive studies, and general acceptance by the medical community (standard of practice), as supported by sound medical evidence. In addition, the intervention must be safe and effective and appropriate including duration and frequency that is considered appropriate for the item or service in terms of whether it is furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function. In addition, the safe and effective provision includes that service must be furnished in a setting appropriate to the patient’s medical needs and condition, ordered and furnished by qualified personnel, the service must meet, but does not exceed, the patient’s medical need, and be at least as beneficial as an existing and available medically appropriate alternative. The LCDs are prepared with literature review, state medical societies, and carrier advisory committees (CACs) of which interventional pain management is a member. The LCDs may be appealed by beneficiaries. The NCDs are prepared by the CMS following a request for a national coverage decision after an appropriate national coverage request along with a draft decision memorandum, and public comments. After the request, the staff review, external technology assessment, Medicare Evidence Development and Coverage Advisory Committee (MedCAC) assessment, public comments, a draft decision memorandum may be posted which will be followed by a final decision and implementation instructions. This decision may be appealed to the department appeals board, but may be difficult to reverse. This manuscript describes NCDs and LCDs and the process of development, their development, issues related to the development, and finally their relation to interventional pain management. Key words: Interventional pain management, interventional techniques, national coverage determinations (NCDs), local coverage determinations (LCDs), contractor medical director (CMD), Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services (HHS), guidelines, evidence-based medicine, evidence development with coverage

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