scholarly journals 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

2011 ◽  
Vol 3;14 (3;5) ◽  
pp. E249-E282
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
United States ◽  
Pain Management ◽  
Affordable Care Act ◽  
Comparative Effectiveness Research ◽  
Outcomes Research ◽  
Comparative Effectiveness ◽  
The United States ◽  
Effectiveness Research ◽  
Patient Centered ◽  
Interventional Pain Management

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.

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
Keyword(s):  
United States ◽  
Health Care ◽  
Pain Management ◽  
Comparative Effectiveness Research ◽  
Comparative Effectiveness ◽  
Clinical Excellence ◽  
The United States ◽  
Effectiveness Research ◽  
Interventional Pain Management ◽  
Care Costs

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.

Comparative Effectiveness Research: The Experience of the National Institute for Health and Clinical Excellence

2012 ◽  
Vol 30 (34) ◽  
pp. 4267-4274 ◽  
Author(s):  
Corinna Sorenson ◽  
Michael Drummond ◽  
Kalipso Chalkidou
Keyword(s):  
United States ◽  
Health Care ◽  
United Kingdom ◽  
Comparative Effectiveness Research ◽  
Comparative Effectiveness ◽  
Clinical Excellence ◽  
The United States ◽  
Effectiveness Research ◽  
Patient Centered ◽  
The United Kingdom

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.

scholarly journals Improving Comparative Effectiveness Research of Complex Health Interventions: Standards from the Patient-Centered Outcomes Research Institute (PCORI)

2020 ◽  
Vol 35 (S2) ◽  
pp. 875-881 ◽  
Author(s):  
Laura C. Esmail ◽  
Rebecca Barasky ◽  
Brian S. Mittman ◽  
David H. Hickam
Keyword(s):  
Comparative Effectiveness Research ◽  
Outcomes Research ◽  
Comparative Effectiveness ◽  
Health Interventions ◽  
Effectiveness Research ◽  
Patient Centered ◽  
Causal Pathways ◽  
Causal Pathway ◽  
Healthcare Interventions ◽  
Research Institute

Abstract Introduction Complex health interventions (CHIs) are increasingly studied in comparative effectiveness research (CER), and there is a need for improvements in CHI research practices. The Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee (MC) launched an effort in 2016 to develop formal guidance on this topic. Objective To develop a set of minimal standards for scientifically valid, transparent, and reproducible CER studies of CHIs. The standards are intended to apply to research examining a broad range of healthcare interventions including delivery system, behavior change, and other non-pharmacological interventions. Methods We conducted a literature review, reviewed existing methods guidance, and developed standards through an iterative process involving the MC, two panels of external research methods experts, and a 60-day public comment period. The final standards were approved by the PCORI MC and adopted by the PCORI Board of Governors on April 30, 2018. Results The final standards include the following: (1) fully describe the intervention and comparator and define their core functions, (2) specify the hypothesized causal pathways and their theoretical basis, (3) specify how adaptations to the form of the intervention and comparator will be allowed and recorded, (4) plan and describe a process evaluation, and (5) select patient outcomes informed by the causal pathway. Discussion The new standards offer three major contributions to research: (1) they provide a simple framework to help investigators address the major methodological features of a CHI study, (2) they emphasize the importance of the causal model and the need to understand how a CHI achieves its effects rather than simply measuring these effects, and (3) they require description of a CHI using the concepts of core functions and forms. While these standards apply formally to PCORI-funded CER studies, they have broad applicability.

Comparative Effectiveness Research under the Patient Protection and Affordable Care Act: Can New Bottles Accommodate Old Wine?

2011 ◽  
Vol 37 (4) ◽  
pp. 522-566 ◽  
Author(s):  
Eleanor D. Kinney
Keyword(s):  
Affordable Care Act ◽  
Comparative Effectiveness Research ◽  
Comparative Effectiveness ◽  
Health Sector ◽  
The United States ◽  
Healthcare Sector ◽  
Cost Curve ◽  
Effectiveness Research ◽  
Patient Protection ◽  
Research Initiative

The Patient Protection and Affordable Care Act (PPACA), as amended by the Health Care and Education Reconciliation Act of 2010, initiated comprehensive health reform for the healthcare sector of the United States. PPACA includes strategies to make the American healthcare sector more efficient and effective. PPACA's comparative effectiveness research initiative and the establishment of the Patient-Centered Outcomes Research Institute are major strategies in this regard. PPACA's comparative effectiveness research initiative is one in a long line of federal initiatives to address the rising costs of healthcare as well as to obtain better value for healthcare expenditures. The key question is whether the governance and design features of the institute that will oversee the initiative will enable it to succeed where other federal efforts have faltered. This Article analyzes the federal government's quest to ensure value for money expended in publically funded healthcare programs and the health sector generally. This Article will also analyze what factors contribute to the possible success or failure of the comparative effectiveness research initiative. Success can be defined as the use of the findings of comparative effectiveness to make medical practice less costly, more efficient and effective, and ultimately, to bend the cost curve.

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