Interventional Pain Management

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Laxmaiah Manchikanti - One of the best experts on this subject based on the ideXlab platform.

  • The Evolution of Interventional Pain Management An Historical Review
    2020
    Co-Authors: Laxmaiah Manchikanti, Mark V. Boswell, Gabor B. Racz
    Abstract:

    Interventional Pain Management dates back to the origins of neural blockade and regional analgesia. Over the years, it evolved into a distinct specialty with the application of Interventional techniques beyond those of simple neural blockade. The first thera peutic nerve block in Pain Management was described in 1899 by Tuffer. Subsequently, numerous techniques of Interventional Pain Management with neural blockade were described. Diagnostic blockade in Pain Management was pioneered by von Gaza with the use of procaine for determining the pathways of obscure Pain. Interventional Pain Management has entered into the modern era in the twenty-first century, driven by contributions from pioneers including Bonica, Winnie, Raj, Racz, Bogduk, and others. This historical review examines the origins of Interventional Pain Management, its pathophysiologic basis, the role of precision diagnostic Interventional techniques, therapeutic Interventional techniques, and the future of Interventional Pain manage

  • Methods for evidence synthesis in Interventional Pain Management.
    Pain Physician, 2020
    Co-Authors: Laxmaiah Manchikanti, David M. Schultz, Gabor B. Racz, James E. Heavner, Nagy Mekhail, Hans Hansen, Singh
    Abstract:

    : Healthcare decisions are increasingly being made on research-based evidence, rather than on expert opinion or clinical experience alone. Consequently, the process by which the strength of scientific evidence is evaluated and developed by means of evidence-based medicine recommendations and guidelines has become crucial resulting in the past decade in unprecedented interest in evidence-based medicine and clinical practice guidelines. Systematic reviews, also known as evidence-based technology assessments, attempt to minimize bias by the comprehensiveness and reproducibility of the search for and selection of articles for review. Evidence-based medicine 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 evidence-based medicine requires the integration of individual clinical expertise with the best available external evidence from systematic research. To arrive at evidence-based medicine decisions all valid and relevant evidence should be considered alongside randomized controlled trials, patient preferences and resources. However, many systematic reviews in Interventional Pain Management fail to follow evidence-based medicine principles. Clinical practice guidelines are systematically developed statements that assist clinicians, consumers and policy makers to make appropriate healthcare decisions. The complex processes of guideline development depend on integration of a number of activities, from collection and processing of scientific literature to evaluation of the evidence, development of evidence-based recommendations or guidelines and implementation and dissemination of the guidelines to relevant professionals and consumers. Guidelines are being designed to improve the quality of healthcare and decrease the use of unnecessary, ineffective or harmful interventions. This review describes various aspects of evidence-based medicine, systematic reviews in Interventional Pain Management, evaluation of the strength of scientific evidence, differences between systematic and narrative reviews, rating the quality of individual articles, grading the strength of the body of evidence and appropriate methods for searching for the evidence.

  • Increasing deaths from opioid analgesics in the United States: An evaluation in an Interventional Pain Management practice
    Journal of opioid management, 2018
    Co-Authors: Ba Kavita N. Manchikanti, Laxmaiah Manchikanti, Vidyasagar Pampati, Rn Kimberly S. Damron, Ma Bert Fellows
    Abstract:

    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.

  • facility payments for Interventional Pain Management procedures impact of proposed rules
    Pain Physician, 2016
    Co-Authors: Laxmaiah Manchikanti, Vijay P. Singh, Joshua A Hirsch
    Abstract:

    UNLABELLED: In the face of the progressive implementation of the Affordable Care Act (ACA), a significant regulatory regime, and the Merit-Based Incentive Payment System (MIPS), the Centers for Medicare and Medicaid Services (CMS) released its proposed 2017 hospital outpatient department (HOPD) and ambulatory surgery center (ASC) payment rules on July 14, 2016, and the physician payment schedule was released July 15, 2016. U.S. health care costs continue to increase, occupying 17.5% of the gross domestic product (GDP) in 2014 and surpassing $3 trillion in overall health care expenditure. Solo and independent practices face unique challenges and many are being acquired by hospitals or larger groups. This transfer of services to hospital settings is indisputably leading to an increase in the net cost to the system. Comparison of facility payments for Interventional techniques in HOPD, ASC, and in-office settings shows wide variation for multiple Interventional techniques. Major discrepancies in payment schedules are related to higher payments for hospitals than comparable treatments in in-office settings and ASCs. In-office procedures, which have been converted to ASC procedures, are reimbursed at as high as 1,366% higher than ASCs and 2,156% higher than in-office settings. The Medicare Payment Advisory Commission (MedPAC) has made recommendations on avoiding the discrepancies and site-of-service differentials in in-office settings, hospital outpatient settings, and ASCs. These have not been implemented by CMS. In addition, there have been slow reductions in reimbursements over the recent years, which continue to accumulate, leading to significant reductions in paymentsIn conclusion, equalization of site-of-service differentials will simultaneously improve reimbursement patterns for Interventional Pain Management procedures, increase access and quality of care, and finally, reduce costs for CMS, extending Medicare solvency. KEY WORDS: Hospital outpatient departments, ambulatory surgery centers, physician in-office services, Interventional Pain Management, Interventional techniques.

  • proposed medicare physician payment schedule for 2017 impact on Interventional Pain Management practices
    Pain Physician, 2016
    Co-Authors: Laxmaiah Manchikanti, Alan D Kaye, Joshua A Hirsch
    Abstract:

    : The Centers for Medicare and Medicaid Services (CMS) released the proposed 2017 Medicare physician fee schedule on July 7, 2016, addressing Medicare payments for physicians providing services either in an office or facility setting, which also includes payments for office expenses and quality provisions for physicians. This proposed rule occurs in the context of numerous policy changes, most notably related to the Medicare Access & CHIP Reauthorization Act of 2015 (MACRA) and its Merit-Based Incentive Payment System (MIPS). The proposed rule affects Interventional Pain Management specialists in reimbursement for evaluation and Management services, as well as procedures performed in a facility or in-office setting.Changes in the proposed fee schedule impacting Interventional Pain Management practices include adjustments to the meaningful use (MU) program, care Management in patient-centered services, identification and review of potentially misvalued services, evaluation of moderate sedation services, Medicare telehealth services, updated geographic practice cost index, data collection on resources used in furnishing global services, reporting of modifier 25 for zero day global services, Medicare Advantage Part C provider and supplier enrollment, appropriate use criteria (AUC) for advanced imaging services, and Medicare shared savings programs. The proposed schedule has provided rates for new epidural codes with or without imaging (fluoroscopy or computed tomography [CT]) and a fee schedule for a new code covering endoscopic spinal decompression. Review of payment rates show major discrepancies in payment schedules with high payments for hospitals, 2,156% higher than in-office procedures. Some procedures which were converted from in-office settings to ambulatory surgery centers (ASCs) are being reimbursed at 1,366% higher than ASCs. The Medicare Payment Advisory Commission (MedPAC) recommendation on avoiding the discrepancies and site-of-service differentials in in-office settings, hospital outpatient settings, and ASCs has not been agreed to by CMS. Thus, even though the changes appear to be minor in physician services and in-office service payment, these changes cumulatively have been reducing payments for Interventional procedures. Further, in-office reimbursement is overall significantly lower than ASCs and hospital outpatient departments (HOPDs) specifically for intraarticular injections, peripheral nerve blocks, and peripheral neurolytic injections. The significant advantage also continues for hospitals in their reimbursement for facility fee for evaluation and Management services.This health policy review describes various issues related to health care expenses, health care reform, and finally its effects on physician payments for all services and also for the services provided in an office setting.

Joshua A Hirsch - One of the best experts on this subject based on the ideXlab platform.

  • facility payments for Interventional Pain Management procedures impact of proposed rules
    Pain Physician, 2016
    Co-Authors: Laxmaiah Manchikanti, Vijay P. Singh, Joshua A Hirsch
    Abstract:

    UNLABELLED: In the face of the progressive implementation of the Affordable Care Act (ACA), a significant regulatory regime, and the Merit-Based Incentive Payment System (MIPS), the Centers for Medicare and Medicaid Services (CMS) released its proposed 2017 hospital outpatient department (HOPD) and ambulatory surgery center (ASC) payment rules on July 14, 2016, and the physician payment schedule was released July 15, 2016. U.S. health care costs continue to increase, occupying 17.5% of the gross domestic product (GDP) in 2014 and surpassing $3 trillion in overall health care expenditure. Solo and independent practices face unique challenges and many are being acquired by hospitals or larger groups. This transfer of services to hospital settings is indisputably leading to an increase in the net cost to the system. Comparison of facility payments for Interventional techniques in HOPD, ASC, and in-office settings shows wide variation for multiple Interventional techniques. Major discrepancies in payment schedules are related to higher payments for hospitals than comparable treatments in in-office settings and ASCs. In-office procedures, which have been converted to ASC procedures, are reimbursed at as high as 1,366% higher than ASCs and 2,156% higher than in-office settings. The Medicare Payment Advisory Commission (MedPAC) has made recommendations on avoiding the discrepancies and site-of-service differentials in in-office settings, hospital outpatient settings, and ASCs. These have not been implemented by CMS. In addition, there have been slow reductions in reimbursements over the recent years, which continue to accumulate, leading to significant reductions in paymentsIn conclusion, equalization of site-of-service differentials will simultaneously improve reimbursement patterns for Interventional Pain Management procedures, increase access and quality of care, and finally, reduce costs for CMS, extending Medicare solvency. KEY WORDS: Hospital outpatient departments, ambulatory surgery centers, physician in-office services, Interventional Pain Management, Interventional techniques.

  • proposed medicare physician payment schedule for 2017 impact on Interventional Pain Management practices
    Pain Physician, 2016
    Co-Authors: Laxmaiah Manchikanti, Alan D Kaye, Joshua A Hirsch
    Abstract:

    : The Centers for Medicare and Medicaid Services (CMS) released the proposed 2017 Medicare physician fee schedule on July 7, 2016, addressing Medicare payments for physicians providing services either in an office or facility setting, which also includes payments for office expenses and quality provisions for physicians. This proposed rule occurs in the context of numerous policy changes, most notably related to the Medicare Access & CHIP Reauthorization Act of 2015 (MACRA) and its Merit-Based Incentive Payment System (MIPS). The proposed rule affects Interventional Pain Management specialists in reimbursement for evaluation and Management services, as well as procedures performed in a facility or in-office setting.Changes in the proposed fee schedule impacting Interventional Pain Management practices include adjustments to the meaningful use (MU) program, care Management in patient-centered services, identification and review of potentially misvalued services, evaluation of moderate sedation services, Medicare telehealth services, updated geographic practice cost index, data collection on resources used in furnishing global services, reporting of modifier 25 for zero day global services, Medicare Advantage Part C provider and supplier enrollment, appropriate use criteria (AUC) for advanced imaging services, and Medicare shared savings programs. The proposed schedule has provided rates for new epidural codes with or without imaging (fluoroscopy or computed tomography [CT]) and a fee schedule for a new code covering endoscopic spinal decompression. Review of payment rates show major discrepancies in payment schedules with high payments for hospitals, 2,156% higher than in-office procedures. Some procedures which were converted from in-office settings to ambulatory surgery centers (ASCs) are being reimbursed at 1,366% higher than ASCs. The Medicare Payment Advisory Commission (MedPAC) recommendation on avoiding the discrepancies and site-of-service differentials in in-office settings, hospital outpatient settings, and ASCs has not been agreed to by CMS. Thus, even though the changes appear to be minor in physician services and in-office service payment, these changes cumulatively have been reducing payments for Interventional procedures. Further, in-office reimbursement is overall significantly lower than ASCs and hospital outpatient departments (HOPDs) specifically for intraarticular injections, peripheral nerve blocks, and peripheral neurolytic injections. The significant advantage also continues for hospitals in their reimbursement for facility fee for evaluation and Management services.This health policy review describes various issues related to health care expenses, health care reform, and finally its effects on physician payments for all services and also for the services provided in an office setting.

  • innovations in Interventional Pain Management of chronic spinal Pain
    Expert Review of Neurotherapeutics, 2016
    Co-Authors: Laxmaiah Manchikanti, Mark V. Boswell, Joshua A Hirsch
    Abstract:

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

  • an updated assessment of utilization of Interventional Pain Management techniques in the medicare population 2000 2013
    Pain Physician, 2015
    Co-Authors: Laxmaiah Manchikanti, F J Falco, Joshua A Hirsch
    Abstract:

    BACKGROUND: The rapid increase in the prevalence of chronic Pain and disability, and the explosion of Interventional Pain Management associated health care costs are a major concern for our community. Further, the increasing utilization of numerous modalities of treatments in managing chronic Pain, continue to escalate at a pace which may not be sustainable. There are multiple regulations in place to control the growth of health care expenditures which seem to have been largely ineffective. Among the various modalities utilized in managing chronic Pain, Interventional techniques have shown a significant increase in their utilization in the face of continued debate with respect to the accuracy of diagnostic interventions and the efficacy of therapeutic interventions. OBJECTIVE: To update and assess the utilization of Interventional techniques in chronic Pain Management in fee-for-service Medicare population. STUDY DESIGN: An updated analysis of the growth of Interventional techniques in managing chronic Pain in fee-for-service Medicare beneficiaries from 2000 through 2013. METHODS: The data were derived and analyzed utilizing the Centers for Medicare and Medicaid Services (CMS) Physician Supplier Procedure Summary Master Data from 2000 through 2013. RESULTS: From 2000 through 2013, in fee-for-service Medicare beneficiaries, the overall utilization of Interventional techniques services increased 236% at an annual average growth of 9.8%, whereas the per 100,000 Medicare population utilization increased 156% with an annual average growth of 7.5%. During this period, the US population increased 12% with an annual average increase of 0.9%, whereas those above 65 years of age increased 27% with an annual average increase of 1.9%. Total Medicare beneficiaries increased 31% with an annual average increase of 2.1%, with an overall increase of 64% for those above 65 years of age, an increase of 26%, constituting 17% of the US population in 2013. The overall increases in epidural and adhesiolysis procedures were 165% compared to 102% per 100,000 fee-for-service population with annual average increases of 7.8% and 5.6%. Facet joint and sacroiliac joint injections increased 417% for services with an annual average increase of 13.5%, whereas the rate per 100,000 fee-for-service Medicare beneficiaries increased 295% with an annual average increase of 11.1%. LIMITATIONS: Limitations of this assessment include the lack of inclusion of participants from Medicare Advantage plans, lack of appropriate available data for state-wide utilization, and potential errors in documentation, coding, and billing. CONCLUSION: This update once again shows a significant increase in Interventional techniques in fee-for-service Medicare beneficiaries from 2000 through 2013 with an increase of 156% per 100,000 Medicare population with an annual average increase of 7.5%. During this period the Medicare population increased 31% with an annual average increase of 2.1%.

  • assessment of methodologic quality of randomized trials of Interventional techniques development of an Interventional Pain Management specific instrument
    Pain Physician, 2014
    Co-Authors: Laxmaiah Manchikanti, Joshua A Hirsch, Mark V. Boswell, F J Falco, James E. Heavner, Steven P Cohen, Sudhir Diwan, Kenneth D Candido, Obi Onyewu, Nalini Sehgal
    Abstract:

    BACKGROUND: A major component of a systematic review is an assessment of the methodological quality and bias of randomized trials. The most commonly utilized methodological quality assessment and bias assessment for randomized trials is by the Cochrane Review Group. While this is not a "gold standard," it is an indication of the current state-of-the-art review methodology. There is, however, no specific instrument to assess the methodological quality of manuscripts published for Interventional techniques. OBJECTIVES: Our objective was to develop an instrument specifically for Interventional Pain Management, to assess the methodological quality of randomized trials of Interventional techniques. METHODS: Item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the trial. Applicability was defined as the extent to which the trial produced procedures could be applied with contemporary Interventional Pain Management techniques. Multiple items based on Cochrane review criteria were utilized along with specific requirements for Interventional techniques. RESULTS: A total of 22 items were developed which formed IPM-QRB or Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment tool. This included 9 of the 12 items from the Cochrane review criteria with definition of some items that were repetitive or duplicate, and the addition of 13 new items. The results were compared for inter-rater reliability of Cochrane review criteria and IPM-QRB, and inter-instrument reliability. The assessment was performed in multiple stages with an initial learning curve. The final assessment was for 4 randomized controlled trials (RCTs) utilizing both Cochrane review criteria and IPM-QRB criteria. The inter-rater agreement for Cochrane review criteria with overall intra-class correlation coefficient was 0.407 compared to an intra-class correlation coefficient of 0.833 for IPM-QRB criteria. The inter-rater agreement was superior for IPM-QRB criteria compared to Cochrane review criteria despite twice the items of Cochrane review criteria as IPM-QRB criteria with the detailed nature of assessment. LIMITATIONS: Limited validity or accuracy assessment of the instrument and the large number of items to be scored. CONCLUSION: We have developed a new comprehensive instrument to assess the methodological quality of randomized trials of Interventional techniques. This instrument is superior to Cochrane review methodology criteria in that it provides more extensive and specific information for Interventional techniques that will be useful in assessing the methodologic quality and bias of Interventional techniques.

A. Srinivasan - One of the best experts on this subject based on the ideXlab platform.

  • outbreak of serratia marcescens bloodstream and central nervous system infections after Interventional Pain Management procedures
    The Clinical Journal of Pain, 2008
    Co-Authors: A. L. Cohen, A Ridpath, M Arduino, Donald Jernigan, B. Jensen, Judith Noblewang, Alicia Peterson, A. Srinivasan
    Abstract:

    ObjectivesTo determine the cause of an outbreak of Serratia marcescens infections in patients after Interventional Pain Management procedures at an outpatient Pain clinic.MethodsWe conducted a case-control study and collected clinical and environmental samples.ResultsWe identified 5 culture-confirme

  • Outbreak of serratia marcescens bloodstream and central nervous system infections after Interventional Pain Management procedures
    Clinical Journal of Pain, 2008
    Co-Authors: A. L. Cohen, A Ridpath, N.-w. Judith, M Arduino, Donald Jernigan, B. Jensen, A.m. Peterson, A. Srinivasan
    Abstract:

    Objectives: To determine the cause of an outbreak of Serratia marcescens infections in patients after Interventional Pain Management procedures at an outpatient Pain clinic. Methods: We conducted a case-control study and collected clinical and environmental samples. Results: We identified 5 culture-confirmed case-patients and 2 presumptive case-patients who had no bacteria recovered from cultures. The 7 case-patients were compared with 28 controls who underwent procedures at the same clinic but did not develop symptoms of infection. All confirmed case-patients had S. marcescens bloodstream infections; 2 had concurrent S. marcescens central nervous system infections. Case-patients were more likely than controls to have procedures that used contrast solution or entered the epidural or intervertebral disc space (P≤1 for each). All S. marcescens clinical isolates were indistinguishable by pulsed-field gel electrophoresis. We did not isolate S. marcescens from medications or environmental samples; however, S. marcescens was shown to survive and grow in contrast solution that was experimentally contaminated for up to 30 days. Single-dose vials of medication, including contrast solution, were used for multiple procedures; multiple medications were accessed with a common needle and syringe. Discussion: The findings of this investigation suggest contamination of a common medication, likely contrast solution, as the source of the outbreak. Practices, such as reusing single-dose medication vials and using a common needle and syringe to access multiple medications, could have led to contamination and propagation of S. marcescens and should be avoided in Interventional Pain Management procedures. © 2008 by Lippincott Williams & Wilkins.

Ramsin M Benyamin - One of the best experts on this subject based on the ideXlab platform.

  • development of an Interventional Pain Management specific instrument for methodologic quality assessment of nonrandomized studies of Interventional techniques
    Pain Physician, 2014
    Co-Authors: L Manchikanti, Joshua A Hirsch, Ramsin M Benyamin, F J Falco, James E. Heavner, Steven P Cohen, Nalini Sehgal, Ricardo Vallejo, Obi Onyewu
    Abstract:

    BACKGROUND: The major component of a systematic review is assessment of the methodologic quality and bias of randomized and nonrandomized trials. While there are multiple instruments available to assess the methodologic quality and bias for randomized controlled trials (RCTs), there is a lack of extensively utilized instruments for observational studies, specifically for Interventional Pain Management (IPM) techniques. Even Cochrane review criteria for randomized trials is considered not to be a "gold standard," but merely an indication of the current state of the art review methodology. Recently a specific instrument to assess the methodologic quality of randomized trials has been developed for Interventional techniques. OBJECTIVES: Our objective was to develop an IPM specific instrument to assess the methodological quality of nonrandomized trials or observational studies of Interventional techniques. METHODS: The item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the study. Applicability was defined as the extent to which procedures produced by the study could be applied using contemporary IPM techniques. Multiple items based on Cochrane review criteria and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) were utilized. RESULTS: A total of 16 items were developed which formed the IPM-QRBNR tool. The assessment was performed in multiple stages. The final assessment was 4 nonrandomized studies. The inter-rater agreement was moderate to good for IPM-QRBNR criteria. LIMITATIONS: Limited validity or accuracy assessment of the instrument and the large number of items to be scored were limitations. CONCLUSION: We have developed a new comprehensive instrument to assess the methodological quality of nonrandomized studies of Interventional techniques. This instrument provides extensive information specific to Interventional techniques is useful in assessing the methodological quality and bias of observational studies of Interventional techniques.

  • value based Interventional Pain Management a review of medicare national and local coverage determination policies
    Pain Physician, 2013
    Co-Authors: L Manchikanti, F J Falco, Ramsin M Benyamin, Helm S Nd, Joshua A Hirsch
    Abstract:

    : 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.

  • assessment of practice patterns of perioperative Management of antiplatelet and anticoagulant therapy in Interventional Pain Management
    Pain Physician, 2012
    Co-Authors: Laxmaiah Manchikanti, Ramsin M Benyamin, F J Falco, S Datta, Bert Fellows, Joshua A Hirsch
    Abstract:

    BACKGROUND: The role of antithrombotic therapy is well known for its primary and secondary prevention of cardiovascular disease by decreasing the incidence of acute cerebral, cardiovascular, peripheral vascular, and other thrombotic events. The overwhelming data show that the risk of thrombotic events is significantly higher than that of bleeding during surgery after antiplatelet drug discontinuation. It has been assumed that discontinuing antiplatelet therapy prior to performing Interventional Pain Management techniques is a common practice, even though doing so may potentially increase the risk of acute cerebral and cardiovascular events. There are no data available concerning these events, specifically in relation to the occurrence of thromboembolic events, even though some data are available concerning bleeding complications. Even then, Interventionalists seem to routinely discontinue all antithrombotic therapy prior to all Interventional Pain Management techniques. OBJECTIVE: To assess the perioperative antiplatelet and anticoagulant practice patterns of US Interventional Pain Management physicians as well as adverse events in patients on antithrombotic therapy who undergo Interventional Pain Management techniques when that therapy is continued or stopped. STUDY DESIGN: An online survey of Interventional Pain Management physicians. STUDY SETTING: Interventional Pain Management practices in the United States. METHODS: An online survey was commissioned among 2,300 members of the American Society of Interventional Pain Physicians. The survey was designed to assess practice patterns and complications encountered. RESULTS: Of the 2,300 members surveyed, 325 responded. These results showed that all physicians discontinued warfarin therapy; whereas, 97% discontinued clopidogrel; 96% ticlopidine; 95% Aggrastat (tirofiban); 93% cilostazol, 85% dipyridamole, 60% aspirin 350 mg; 39% aspirin 81 mg; and 39% other nonsteroidal anti-inflammatory drugs (NSAIDs) prior to performing Interventional Pain Management techniques. The majority of physicians accepted an international normalized ratio of 1.5 or less as a safe level. An assessment of serious complications showed thromboembolic events were 3 times more frequent than bleeding complications: 162 thromboembolic events and 55 serious bleeding complications from epidural hematomas. Thromboembolic complications were severe and higher when antiplatelet therapy was discontinued. Bleeding complications from epidural hematomas were similar whether antiplatelet therapy was continued or discontinued (26 versus 29). LIMITATIONS: This study was limited by its being an online survey of the membership of one organization in one country and that there was a 14% response rate. Underreporting in surveys is common. Further, the incidence of thromboembolic events or epidural hematomas may be misrepresented as a percentage since these drugs were continued in a very small percentage of patients. Consequently, the incidences described in this manuscript may not show appropriate percentages. CONCLUSION: The results illustrate an overwhelming pattern of discontinuing antiplatelet and warfarin therapy as well as aspirin and other NSAIDs prior to performing Interventional Pain Management techniques. However, thromboembolism complications may be 3 times more prevalent than epidural hematomas (162 versus 55 events). It is concluded that clinicians must balance the risks of thromboembolism and bleeding in each patient prior to the routine discontinuation of antiplatelet therapy.

  • proposed physician payment schedule for 2013 guarded prognosis for Interventional Pain Management
    Pain Physician, 2012
    Co-Authors: L Manchikanti, F J Falco, Ramsin M Benyamin, David Caraway, Joshua A Hirsch
    Abstract:

    : As happens every year, on July 1, 2012, the Centers for Medicare and Medicaid Services issued a proposed policy and payment rate for services furnished under the Medicare physician fee schedule for 2013. The proposed rule would provide certified registered nurse anesthetists to practice independent Interventional Pain Management. Other issues, though no less important, include a 27% sustainable growth rate formula cut in reimbursement, along with a 2% sequester, which could lead to a potential cut of 29%. Since the inception of Medicare programs in 1965, several methods have been used to determine the amounts paid to physicians for each covered service. The sustainable growth rate was enacted in 1997 to determine physician payment updates under Medicare Part B. Its intent was to reduce Medicare physician payment updates to offset the growth and utilization of physician services that exceed gross domestic product growth. This is achieved by setting an overall target amount of spending for physicians' services and adjusting payment rates annually to reflect differences between actual spending and the spending target. Since 2002, the sustainable growth rate has annually been used to recommend reductions in Medicare reimbursements. Payments were cut in 2002 by 4.8%. Since then, Congress has intervened on multiple occasions to prevent additional cuts from being imposed. In this manuscript, we will describe important proposed changes to the physician fee schedule. Additionally, the impact of multiple changes on Interventional Pain Management will be briefly described.

  • cms proposal for Interventional Pain Management by nurse anesthetists evidence by proclamation with poor prognosis
    Pain Physician, 2012
    Co-Authors: Laxmaiah Manchikanti, Ramsin M Benyamin, Frank J E Falco, Hans Hansen, David Caraway, Joshua A Hirsch
    Abstract:

    : The Office of Inspector General (OIG), Department of Health and Human Services (HHS), in a 2009 report, showed that unqualified nonphysicians performed 21% of the services. These nonphysicians did not possess the necessary licenses, certifications, credentials, or training to perform the services. Since the time the medical profession was founded, advances in treatments and technology, as well as educational and training standards, have promoted a desire to go beyond the basic scope of practice. Many have sought to broaden the scope of practice through legislative efforts and proclamation rather than education and training. In 2001, President Clinton signed into law a rule that permitted states to "opt out" of the Centers for Medicare and Medicaid Services' (CMS) requirement for nurse anesthetists to be supervised by any physician. Since then, 17 states have adopted this rule. While it was originally intended to help rural areas improve access to care, the opt out rule essentially supports any hospital or organization that seeks to make a profit or cut costs by allowing nurse anesthetists to function as physicians. With the implementation of sweeping health care regulations under the Affordable Care Act (ACA, also popularly known as Obamacare), the future of nurses and other professionals has been empowered. In fact, it has been proposed that medical training may be reduced by 30%, which will in their minds equalize training between nonphysicians and physicians. In 2010, the Federal Trade Commission (FTC) issued an opinion exerting their power to empower CRNAs with unlimited practice, with threats to opposing parties. In the 2013 proposed physician payment rule, CMS is proposing that CRNAs may perform Interventional Pain Management services. Interventional Pain Management is a medical discipline with defined Interventional techniques to be performed by professionals who are well trained and qualified. Without considering the consequences of the lack of education and training qualifications for CRNAs to offer Interventional techniques, the FTC issued their opinion and CMS proposed to expand these practice patterns with a policy of improved access and reduced cost. However, in reality, the opposite will happen and will increase fraud, reduce access due to inappropriate procedures, and increase complications, all as a result of privileges by legislation without education. The CMS proposal for Interventional Pain Management by nurse anesthetists is a proclamation with a poor prognosis.

L Manchikanti - One of the best experts on this subject based on the ideXlab platform.

  • development of an Interventional Pain Management specific instrument for methodologic quality assessment of nonrandomized studies of Interventional techniques
    Pain Physician, 2014
    Co-Authors: L Manchikanti, Joshua A Hirsch, Ramsin M Benyamin, F J Falco, James E. Heavner, Steven P Cohen, Nalini Sehgal, Ricardo Vallejo, Obi Onyewu
    Abstract:

    BACKGROUND: The major component of a systematic review is assessment of the methodologic quality and bias of randomized and nonrandomized trials. While there are multiple instruments available to assess the methodologic quality and bias for randomized controlled trials (RCTs), there is a lack of extensively utilized instruments for observational studies, specifically for Interventional Pain Management (IPM) techniques. Even Cochrane review criteria for randomized trials is considered not to be a "gold standard," but merely an indication of the current state of the art review methodology. Recently a specific instrument to assess the methodologic quality of randomized trials has been developed for Interventional techniques. OBJECTIVES: Our objective was to develop an IPM specific instrument to assess the methodological quality of nonrandomized trials or observational studies of Interventional techniques. METHODS: The item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the study. Applicability was defined as the extent to which procedures produced by the study could be applied using contemporary IPM techniques. Multiple items based on Cochrane review criteria and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) were utilized. RESULTS: A total of 16 items were developed which formed the IPM-QRBNR tool. The assessment was performed in multiple stages. The final assessment was 4 nonrandomized studies. The inter-rater agreement was moderate to good for IPM-QRBNR criteria. LIMITATIONS: Limited validity or accuracy assessment of the instrument and the large number of items to be scored were limitations. CONCLUSION: We have developed a new comprehensive instrument to assess the methodological quality of nonrandomized studies of Interventional techniques. This instrument provides extensive information specific to Interventional techniques is useful in assessing the methodological quality and bias of observational studies of Interventional techniques.

  • value based Interventional Pain Management a review of medicare national and local coverage determination policies
    Pain Physician, 2013
    Co-Authors: L Manchikanti, F J Falco, Ramsin M Benyamin, Helm S Nd, Joshua A Hirsch
    Abstract:

    : 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.

  • proposed physician payment schedule for 2013 guarded prognosis for Interventional Pain Management
    Pain Physician, 2012
    Co-Authors: L Manchikanti, F J Falco, Ramsin M Benyamin, David Caraway, Joshua A Hirsch
    Abstract:

    : As happens every year, on July 1, 2012, the Centers for Medicare and Medicaid Services issued a proposed policy and payment rate for services furnished under the Medicare physician fee schedule for 2013. The proposed rule would provide certified registered nurse anesthetists to practice independent Interventional Pain Management. Other issues, though no less important, include a 27% sustainable growth rate formula cut in reimbursement, along with a 2% sequester, which could lead to a potential cut of 29%. Since the inception of Medicare programs in 1965, several methods have been used to determine the amounts paid to physicians for each covered service. The sustainable growth rate was enacted in 1997 to determine physician payment updates under Medicare Part B. Its intent was to reduce Medicare physician payment updates to offset the growth and utilization of physician services that exceed gross domestic product growth. This is achieved by setting an overall target amount of spending for physicians' services and adjusting payment rates annually to reflect differences between actual spending and the spending target. Since 2002, the sustainable growth rate has annually been used to recommend reductions in Medicare reimbursements. Payments were cut in 2002 by 4.8%. Since then, Congress has intervened on multiple occasions to prevent additional cuts from being imposed. In this manuscript, we will describe important proposed changes to the physician fee schedule. Additionally, the impact of multiple changes on Interventional Pain Management will be briefly described.

  • the impact of comparative effectiveness research on Interventional Pain Management evolution from medicare modernization act to patient protection and affordable care act and the patient centered outcomes research institute
    Pain Physician, 2011
    Co-Authors: L Manchikanti, Ramsin M Benyamin, F J Falco, Helm S Nd, Allan T Parr, Joshua A Hirsch
    Abstract:

    : The Patient-Centered Outcomes Research Institute (PCORI) was established by the Affordable Care Act of 2010 to promote comparative effectiveness research (CER) to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis. The development of PCORI is vested in the Medicare Modernization Act (MMA) and the American Recovery and Reinvestment Act (ARRA). The framework of CER and PCORI describes multiple elements which are vested in all 3 regulations including stakeholder involvement, public participation, and open transparent decision-making process. Overall, PCORI is much more elaborate with significant involvement of stakeholders, transparency, public participation, and open decision-making. However, there are multiple issues concerning the operation of such agencies in the United States including the predecessor of Agency for Healthcare Research and Quality (AHRQ), the Agency for Healthcare Policy and Research (AHCPR), AHRQ Effectiveness Health Care programs, and others. The CER in the United States may be described at cross-roads or at the beginnings of a scientific era of CER and evidence-based medicine (EBM). However the United States suffers as other countries, including the United Kingdom with its National Health Services (NHS) and National Institute for Health and Clinical Excellence (NICE), with major misunderstandings of methodology, an inordinate focus on methodological assessment, lack of understanding of the study design (placebo versus active control), lack of involvement of clinicians, and misinterpretation of the evidence which continues to be disseminated. Consequently, PCORI and CER have been described as government-driven solutions without following the principles of EBM with an extensive focus on costs rather than quality. It also has been stated that the central planning which has been described for PCORI and CER, a term devised to be acceptable, will be used by third party payors to override the physician's best medical judgement and patient's best interest. Further, stakeholders in PCORI are not scientists, are not balanced, and will set an agenda with an ultimate problem of comparative effectiveness and PCORI that it is not based on medical science, but rather on political science and not even under congressional authority, leading to unprecedented negative changes to health care. Thus, PCORI is operating in an ad hoc manner that is incompatible with the principles of evidence-based practice.This manuscript describes the framework of PCORI, and the role of CER and its impact on Interventional Pain Management.

  • Interventional Pain Management at crossroads the perfect storm brewing for a new decade of challenges
    Pain Physician, 2010
    Co-Authors: L Manchikanti, M V Boswell
    Abstract:

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