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

scholarly journals An Update of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain. Part I: Introduction and General Considerations

2013 ◽  
Vol 2s;16 (2s;4) ◽  
pp. S1-S48
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Systematic Review ◽  
Clinical Practice ◽  
Pain Management ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Methodological Quality ◽  
Expert Advice ◽  
Evidence Based ◽  
Consensus Statements ◽  
Interventional Pain Management

In 2011, the Institute of Medicine (IOM) re-engineered its definition of clinical guidelines as follows: “clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefit and harms of alternative care options.” This new definition departs from a 2-decade old definition from a 1990 IOM report that defined guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.” The revised definition clearly 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. The IOM committee acknowledged that for many clinical domains, high quality evidence was lacking or even nonexistent. Even though the guidelines are important decisionmaking tools, along with expert clinical judgment and patient preference, their value and impact remains variable due to numerous factors. Some of the many factors that impede the development of clinical practice guidelines include bias due to a variety of conflicts 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 elimination of clinician autonomy, and overzealous and inappropriate recommendations, either positive, negative, or non-committal. Consequently, a knowledgeable, multidisciplinary panel of experts must develop guidelines based on a systematic review of the existing evidence, as recently recommended by the IOM. Chronic pain is a complex and multifactorial phenomenon associated with significant economic, social, and health outcomes. Interventional pain management is an emerging specialty facing a disproportionate number of challenges compared to established medical specialties, including the inappropriate utilization of ineffective and unsafe techniques. In 2000, the American Society of Interventional Pain Physicians (ASIPP) created treatment guidelines to help practitioners. There have been 5 subsequent updates. These guidelines address the issues of systematic evaluation and ongoing care of chronic or persistent pain, and provide information about the scientific basis of recommended procedures. These guidelines are expected to increase patient compliance; dispel misconceptions among providers and patients, manage patient expectations reasonably; and form the basis of a therapeutic partnership between the patient, the provider, and payers. Key words: Evidence-based medicine (EBM), comparative effectiveness research (CER), clinical practice guidelines, systematic reviews, meta-analysis, interventional pain management, evidence synthesis, methodological quality assessment, clinical relevance, recommendations.

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.

Interventional Pain Management: An Appraisal and Evidence-based Review

2011 ◽  
Vol 23 (1-4) ◽  
pp. 135-146
Author(s):  
Maged Hamza ◽  
Andrew Medvadovsky ◽  
Timothy Reis ◽  
Audra Eason ◽  
Mauna Radahd ◽  
...  
Keyword(s):  
Pain Management ◽  
Evidence Based ◽  
Interventional Pain Management

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

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 Society of Vascular and Interventional Neurology Standards and Parameters for Guideline Development and Publication

2021 ◽  
Author(s):  
Alicia C. Castonguay ◽  
Adam de Havenon ◽  
Thabele M. Leslie‐Mazwi ◽  
Cynthia Kenmuir ◽  
Sunil A. Sheth ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
American Heart ◽  
Guideline Development ◽  
Heart Association ◽  
Standardize Patient ◽  
Evidence Based ◽  
Level Of Evidence ◽  
High Quality Evidence ◽  
Practice Parameters ◽  
Quality Evidence

Abstract BACKGROUND As much of the scope of neurointerventional practice falls outside data covered by existing randomized clinical trials, and, as a result, may have failed to enter into existing guidelines, an evidence‐based framework for guideline and standards development is needed. We establish an evidence‐based framework to guide all subsequent guidelines and brief practice updates produced by the Society of Vascular and Interventional Neurology (SVIN). METHODS The SVIN formed the Guidelines and Practice Parameters committee to develop the structure and procedures for guidelines and brief practice updates. RESULTS In this article, the Guidelines and Practice Parameters committee has outlined the process by which the guidelines will be created and approved by the SVIN. Additionally, the Guidelines and Practice Parameters committee has adopted the American College of Cardiology/American Heart Association framework of Class of Recommendation and Level of Evidence. A unique, additional separation of the Expert Opinion endorsement category has been developed when high‐quality evidence does not exist at the time of the publication. CONCLUSIONS The SVIN has developed an evidence‐based framework for all guideline statements and brief practice updates. The SVIN guidelines and brief practice updates will guide clinicians in the field of interventional neurology to improve and standardize patient care.

scholarly journals Evidence-Based Interventional Pain Management: Principles, Problems, Potential and Applications

2007 ◽  
Vol 2;10 (3;2) ◽  
pp. 329-356
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Clinical Practice ◽  
Pain Management ◽  
Systematic Reviews ◽  
Evidence Based Medicine ◽  
Randomized Trials ◽  
Evidence Synthesis ◽  
Evidence Based ◽  
Interventional Pain Management ◽  
Based Medicine

Background: The past decade has been marked by unprecedented interest in evidencebased medicine (EBM) and a focus upon the use of innovative methods and protocols to provide valid and reliable information for and about healthcare. Thus (it is at least purported that), healthcare decisions are increasingly being based upon research-derived evidence, rather than on expert opinion or clinical experience alone. But this quest for evidence to support clinical practice also compels the question of whether the methods employed to acquire information, the ranking of information that is acquired, and the prudent use of this information are sound enough to actually sustain the validity of an evidence-based paradigm in practice. Moreover, it is becoming apparent that the scope, depth, and applicability of available evidence to effectively and ethically guide the myriad of situational decisions in clinical practice is not uniform across all medical fields or disciplines. In particular, comprehensive evidence synthesis or complete guidelines for clinical decision-making in interventional pain management remain relatively scarce. EBM is defined as the conscientious, explicit, and judicious use of the current best evidence in making decisions about the care of individual patients. Thus, the practice of EBM requires the integration of individual clinical expertise with the best available external evidence from systematic research. To arrive at evidence-based medical decisions all valid and relevant evidence should be considered alongside randomized controlled trials, patient preferences, and resources. Objective: To describe principles of EBM, and the methods and relative utility of evidence synthesis in interventional pain management. Description: This review provides 1) an understanding of evidence-based medicine, 2) an overview of issues related to evaluating the quality of individual studies, analyses, narrative, and systematic reviews, 3) discussion of factors affecting the strength and value(s) of evidence, 4) analysis of specific reviews of interventional techniques, and finally, 5) the utility and purpose of guidelines in interventional pain management. Conclusion: Interpreting and understanding evidence synthesis, systematic reviews and other analytic literature is a difficult task. It is crucial for pain physicians to understand the goals, principles, and process(es) of EBM so as to meaningfully improve its application(s). This knowledge affords better insight into not only the analytic reviews in interventional pain management provided herein, but ultimately allows future information to be selected, evaluated, and used with prudence in technically competent, ethically sound medical practice. Key words: Interventional pain management, interventional techniques, evidence-based medicine, evidence synthesis, pragmatic or practical clinical trials, randomized trials, observational studies, non-randomized trials, systematic reviews, quality of evidence

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)

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