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.

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.

scholarly journals Facts, Fallacies, and Politics of Comparative Effectiveness Research: Part I. Basic Considerations

2010 ◽  
Vol 1;13 (1;1) ◽  
pp. E23-E54
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
United States ◽  
Health Care ◽  
Medical Care ◽  
Comparative Effectiveness Research ◽  
Comparative Effectiveness ◽  
Clinical Excellence ◽  
The United States ◽  
Evidence Based ◽  
Effectiveness Research ◽  
Care Costs

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.

Comparative effectiveness research and the rise of orphan indications

2014 ◽  
Vol 8 (2) ◽  
pp. 151-163
Author(s):  
Sarah Jeffers ◽  
Mark Slomiany ◽  
Rema Bitar ◽  
Sarah Kruse ◽  
Mahmud Hassan
Keyword(s):  
Pharmaceutical Industry ◽  
Rare Disease ◽  
Affordable Care Act ◽  
Comparative Effectiveness Research ◽  
Comparative Effectiveness ◽  
Cost Effective ◽  
Orphan Drugs ◽  
Effectiveness Research ◽  
Content Type ◽  
The Affordable Care Act

Purpose – The purpose of this paper is to show the link between the comparative effectiveness research (CER) and the interest in developing drugs for rare disease by the pharmaceutical industry. Total healthcare spending is on the rise without having a corresponding better health outcome. As such, with the growing role of government in healthcare, measuring and demonstrating value is beginning to expand beyond the private sector to metrics applied in the public sector. A modern approach to comparative effective research began its rapid rise in the USA when the American Recovery and Reinvestment Act of 2009 allocated $1.1 billion for CER. This paper analyzes the implication and impact on the pharmaceutical industry. Design/methodology/approach – The paper reviews the basic definitions of CER and its areas of strength and weakness. It used real examples of drugs to show the impact of the Reinvestment Act of 2009 on the rise of orphan drugs. Findings – The study shows that the act encouraged the development of orphan drugs, mainly because of the low budget impact due to a smaller patient base. Provisions of the Affordable Care Act provide incentives for such rare disease indications, as no one can be denied coverage with pre-existing conditions. Research limitations/implications – The study is limited by the number of available rare drugs and the ongoing process of implementation of the Affordable Care Act. Practical implications – The study shows the cost-effective method of treating medical conditions. Social implications – Development of orphan drugs opens up access to care for many patients at a cost-effective price. Originality/value – This paper shows the link between the CER and the interest in developing drugs for rare disease by the pharmaceutical industry. It also brings out the possible implication of the Affordable Care Act on the pharmaceutical industry with respect to its strategies for drug development and drug portfolio.

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