scholarly journals Facts, Fallacies, and Politics of Comparative Effectiveness Research: Part 2 - Implications for Interventional Pain Management

2010 ◽  
Vol 1;13 (1;1) ◽  
pp. E55-E79
Author(s):  
Laxmaiah Manchikanti

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

2010 ◽  
Vol 1;13 (1;1) ◽  
pp. E23-E54
Author(s):  
Laxmaiah Manchikanti

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


2011 ◽  
Vol 3;14 (3;5) ◽  
pp. E249-E282
Author(s):  
Laxmaiah Manchikanti

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. Key words: Patient-Centered Outcomes Research Institute (PCORI), comparative effectiveness research (CER), National Institute for Health and Clinical Excellence (NICE), Patient Protection and Affordable Care Act (ACA), Medicare Modernization Act (MMA), American Recovery and Reinvestment Act (ARRA), interventional pain management, interventional techniques, evidencebased medicine, systematic reviews.


2012 ◽  
Vol 30 (34) ◽  
pp. 4267-4274 ◽  
Author(s):  
Corinna Sorenson ◽  
Michael Drummond ◽  
Kalipso Chalkidou

Purpose To assess the relevance of the experience of the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom to the comparative effectiveness research (CER) initiative in the United States. Methods The activities of NICE were reviewed to assess its experience in analytic methods, engagement with stakeholders, communication of findings, and implementation of recommendations. Results The main lessons for the United States from the experience of NICE relate to how the institute has gathered, synthesized, and used information on the clinical and cost effectiveness of health care interventions. The experience of NICE suggests that ways will have to be found to reconcile the differing stakeholder perspectives on the value of health care. Given the emphasis in the United States on being patient centered, there will be situations where patients' expectations for the provision of care far exceed that which payers feel should be made available on grounds of value for money. Explicit restrictions on access to care based on CER like those found in the United Kingdom are unlikely, but alternative solutions, such as value-based reimbursement, will need to be pursued if unnecessary expenditures are to be avoided. It will also be important that the CER initiative show some impact on the use of health care resources. The longer that NICE has been in existence in the United Kingdom, questions about its impact have been more frequently asked, given the resources devoted to its activities. Conclusion Although there are distinct differences between the health systems of the United Kingdom and United States, lessons can be learned from examining the successes and challenges experienced by NICE.


2010 ◽  
Vol 2;13 (1;2) ◽  
pp. E111-E140
Author(s):  
Laxmaiah Manchikanti

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


2012 ◽  
Vol 30 (34) ◽  
pp. 4262-4266 ◽  
Author(s):  
Jeffrey S. Hoch ◽  
David C. Hodgson ◽  
Craig C. Earle

Recently, the evidence-based drug funding process in Ontario, Canada, was challenged by a young mother with a breast tumor too small, based on the evidence that existed at the time, to qualify for an expensive drug. In reality, this is only the latest in a number of challenges the publicly funded health care system has had to deal with in the face of an evolving drug policy landscape. This article defines comparative effectiveness research (CER), considering how it is viewed differently in the United States and Canada. It also reviews the role CER now plays in the Ontario drug funding process and concludes with a review of the challenges and opportunities of using observational data to conduct CER and incorporate it into policy making within a universal health care system. Many of the issues faced by Ontario are relevant beyond Canada, including in the United States during this period of health care reform.


2020 ◽  
Vol 4S;23 (8;4S) ◽  
pp. S271-S282
Author(s):  
Amol Soin

Background: Burnout has been a commonly discussed issue for the past ten years among physicians and other health care workers. A survey of interventional pain physicians published in 2016 reported high levels of emotional exhaustion, often considered the most taxing aspect of burnout. Job dissatisfaction appeared to be the leading agent in the development of burnout in pain medicine physicians in the United States. The COVID-19 pandemic has drastically affected the entire health care workforce and interventional pain management, with other surgical specialties, has been affected significantly. The COVID-19 pandemic has placed several physical and emotional stressors on interventional pain management physicians and this may lead to increased physician burnout. Objective: To assess the presence of burnout specific to COVID-19 pandemic among practicing interventional pain physicians. Methods: American Society of Interventional Pain Physicians (ASIPP) administered a 32 question survey to their members by contacting them via commercially available online marketing company platform. The survey was completed on www.constantcontact.com. Results: Of 179 surveys sent, 100 responses were obtained. The data from the survey demonstrated that 98% of physician practices were affected by COVID and 91% of physicians felt it had a significant financial impact. Sixty seven percent of the physicians responded that inhouse billing was responsible for their increased level of burnout, whereas 73% responded that electronic medical records (EMRs) were one of the causes. Overall, 78% were very concerned. Almost all respondents have been affected with a reduction in interventional procedures. 60% had a negative opinion about the future of their practice, whereas 66% were negative about the entire health care industry. Limitations: The survey included only a small number of member physicians. Consequently, it may not be generalized for other specialties or even pain medicine. However, it does represent the sentiment and present status of interventional pain management. Conclusion: The COVID-19 pandemic has put interventional pain practices throughout the United States under considerable financial and psychological stress. It is essential to quantify the extent of economic loss, offer strategies to actively manage provider practice/wellbeing, and minimize risk to personnel to keep patients safe. Key Words: Interventional pain management, burnout, interventional pain physician, corona COVID-19, financial stress, anxiety, depression


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