Underlying today's and the future's health-care reform debate is a consensus that America's health-care financing system is in a slow-moving but deep crisis: care appears substandard in comparison with other advanced industrial countries, and relative costs are exploding beyond all reasonable measures. The Obama Administration's Patient Protection and Affordable Care Act (ACA) attempts to grapple with both of these problems. One of ACA's key instrumentalities is the Independent Payment Advisory Board-the IPAB, designed to discover and authorize ways to reduce the rate of growth of Medicare and other categories of health spending. The IPAB is a peril. Expert boards to perform regulatory tasks in the interest of efficiency and social goals always run a high risk of being captured by the industry they are supposed to regulate. Even should it succeed at its task of reducing the rate of growth of Medicare spending, who is to say that the reductions will not come at a heavy cost in reduced quantity and effectiveness of medical care? But the IPAB also has promise. The need for a better process than our current specialist-driven one to assign value to the medical services provided by Medicare is great. The bellwether status of Medicare payment systems means that commercial insurance consumers and payors would also benefit mightily from bringing more coherent, technocratic, and cost-effectiveness oriented logic to this process. And the current system of relative Medicare reimbursement rates is, in the judgment of many, currently well out of whack. We quail when we consider the magnitude of the tasks the IPAB faces--even its initial task. Nevertheless, we remain optimistic that this administrative agency will manage to bend the long-run healthcare cost curve and moderate future price increases.
{"title":"Bending the health cost curve: the promise and peril of the Independent Payment Advisory Board.","authors":"Ann Marie Marciarille, J Bradford DeLong","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Underlying today's and the future's health-care reform debate is a consensus that America's health-care financing system is in a slow-moving but deep crisis: care appears substandard in comparison with other advanced industrial countries, and relative costs are exploding beyond all reasonable measures. The Obama Administration's Patient Protection and Affordable Care Act (ACA) attempts to grapple with both of these problems. One of ACA's key instrumentalities is the Independent Payment Advisory Board-the IPAB, designed to discover and authorize ways to reduce the rate of growth of Medicare and other categories of health spending. The IPAB is a peril. Expert boards to perform regulatory tasks in the interest of efficiency and social goals always run a high risk of being captured by the industry they are supposed to regulate. Even should it succeed at its task of reducing the rate of growth of Medicare spending, who is to say that the reductions will not come at a heavy cost in reduced quantity and effectiveness of medical care? But the IPAB also has promise. The need for a better process than our current specialist-driven one to assign value to the medical services provided by Medicare is great. The bellwether status of Medicare payment systems means that commercial insurance consumers and payors would also benefit mightily from bringing more coherent, technocratic, and cost-effectiveness oriented logic to this process. And the current system of relative Medicare reimbursement rates is, in the judgment of many, currently well out of whack. We quail when we consider the magnitude of the tasks the IPAB faces--even its initial task. Nevertheless, we remain optimistic that this administrative agency will manage to bend the long-run healthcare cost curve and moderate future price increases.</p>","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"22 1","pages":"75-121"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30635811","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This Article focuses on an often overlooked barrier to efforts to enhance the quality of health care: the relationship crisis that currently exists between physicians and patients. This state of affairs has resulted from the divide between the medical and legal worlds. The medical arena has understandably tended to view the doctor-patient relationship as a purely medical issue, ignoring the law's impact in generating and sustaining problematic relationship patterns. The legal world has yet to fully recognize this state of affairs, and the law's role in its evolution and persistence. We offer a relational approach to health-care law as a means of bridging the divide between the two disciplines. In the malpractice context, this would entail adopting a no-fault compensation scheme, which is committed to strengthening collaborative doctor-patient relations, enhancing patient safety and systemic learning, while providing adequate compensation.
{"title":"Quality of health care and the role of relationships: bridging the medico-legal divide.","authors":"Sagit Mor, Orna Rabinovich Einy","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This Article focuses on an often overlooked barrier to efforts to enhance the quality of health care: the relationship crisis that currently exists between physicians and patients. This state of affairs has resulted from the divide between the medical and legal worlds. The medical arena has understandably tended to view the doctor-patient relationship as a purely medical issue, ignoring the law's impact in generating and sustaining problematic relationship patterns. The legal world has yet to fully recognize this state of affairs, and the law's role in its evolution and persistence. We offer a relational approach to health-care law as a means of bridging the divide between the two disciplines. In the malpractice context, this would entail adopting a no-fault compensation scheme, which is committed to strengthening collaborative doctor-patient relations, enhancing patient safety and systemic learning, while providing adequate compensation.</p>","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"22 1","pages":"123-38"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30635813","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This Article argues that the current approach of the Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS) to enforcement of the Ethics in Patient Referrals Act (the "Stark Law") is unnecessarily punitive and discourages health-care providers from self-disclosing even very minor violations of the Stark Law. This Article suggests a number of specific changes to encourage provider self-disclosure and proposes that CMS create a demonstration project under the authority of the Patient Protection and Affordable Care Act to test the reforms. A demonstration project provides the perfect vehicle to prove that increased self-disclosure protocols for the Stark Law can decrease the government's costs of enforcement, improve program integrity, and encourage providers to deal responsibly with the inevitable minor lapses in compliance that arise in such an enormous government program as Medicare.
{"title":"Catching flies with vinegar: a critique of the Centers for Medicare and Medicaid self-disclosure program.","authors":"Jean Wright Veilleux","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This Article argues that the current approach of the Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS) to enforcement of the Ethics in Patient Referrals Act (the \"Stark Law\") is unnecessarily punitive and discourages health-care providers from self-disclosing even very minor violations of the Stark Law. This Article suggests a number of specific changes to encourage provider self-disclosure and proposes that CMS create a demonstration project under the authority of the Patient Protection and Affordable Care Act to test the reforms. A demonstration project provides the perfect vehicle to prove that increased self-disclosure protocols for the Stark Law can decrease the government's costs of enforcement, improve program integrity, and encourage providers to deal responsibly with the inevitable minor lapses in compliance that arise in such an enormous government program as Medicare.</p>","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"22 1","pages":"169-225"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30635815","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This Article examines university opposition to a proposed statutory exemption to infringement liability for basic genetic research and patient care. Gene patenting has allowed patentees to bar basic genetic research, slowing the progress of developing and administering diagnostics and gene-targeting therapeutics. Debates over the merits of gene patents have been heated, most recently leading to an unprecedented invalidation of several broad patents covering all variations and use of two genes linked to breast and ovarian cancers. More important, however (as this ruling was reversed in part), are proposed statutory exemptions to infringement liability. The Department of Health and Human Services' Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) has promulgated an exemption from liability for infringement that occurs in the course of research. This exemption would promote basic research by granting academic scientists unfettered access to genetic material. The proposal does not alter the patentability of gene sequences; it merely restricts patentees from using infringement threats to stop research. Surprisingly, the Association of University Technology Managers (AUTM), an organization responsible for promoting development of university research, opposes such an exemption. The AUTM alleges that the exemption would slow research by reducing the incentive for private firms to invest in upstream discoveries made in university laboratories. Yet the exemption would do the opposite: by opening the doors to research relating to any gene segment, a research exemption would accelerate basic research. Moreover, it would not affect collaboration with private industry: where there is potential to commercialize basic research, biomedical companies would continue to license the rights to university discoveries. Thus, the AUTM's motivations in opposing the proposed research exemption are suspect. They appear to reflect either a misunderstanding of the purpose behind granting property rights to publicly funded university research, or an improper alignment with industry goals.
{"title":"University opposition to unfettered research: a new bedfellow for biotech?","authors":"Katherine L Record","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This Article examines university opposition to a proposed statutory exemption to infringement liability for basic genetic research and patient care. Gene patenting has allowed patentees to bar basic genetic research, slowing the progress of developing and administering diagnostics and gene-targeting therapeutics. Debates over the merits of gene patents have been heated, most recently leading to an unprecedented invalidation of several broad patents covering all variations and use of two genes linked to breast and ovarian cancers. More important, however (as this ruling was reversed in part), are proposed statutory exemptions to infringement liability. The Department of Health and Human Services' Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) has promulgated an exemption from liability for infringement that occurs in the course of research. This exemption would promote basic research by granting academic scientists unfettered access to genetic material. The proposal does not alter the patentability of gene sequences; it merely restricts patentees from using infringement threats to stop research. Surprisingly, the Association of University Technology Managers (AUTM), an organization responsible for promoting development of university research, opposes such an exemption. The AUTM alleges that the exemption would slow research by reducing the incentive for private firms to invest in upstream discoveries made in university laboratories. Yet the exemption would do the opposite: by opening the doors to research relating to any gene segment, a research exemption would accelerate basic research. Moreover, it would not affect collaboration with private industry: where there is potential to commercialize basic research, biomedical companies would continue to license the rights to university discoveries. Thus, the AUTM's motivations in opposing the proposed research exemption are suspect. They appear to reflect either a misunderstanding of the purpose behind granting property rights to publicly funded university research, or an improper alignment with industry goals.</p>","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"22 1","pages":"139-67"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30635814","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Rehabilitating opioid regulation: a prescription for the FDA's next proposal of an opioid risk evaluation and mitigation strategy (REMS).","authors":"Hilary Homenko","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"22 1","pages":"273-313"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30635817","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Food and Drug Administration v. the First Amendment: a survey of recent FDA enforcement.","authors":"Gerald Masoudi, Christopher Pruitt","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"21 1","pages":"111-47"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30082285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"DNA to play: Major League Baseball's use of DNA testing on Central and South American prospects in the age of the Genetic Information Nondiscrimination Act of 2008.","authors":"Nicholas Pompeo","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"21 2","pages":"627-53"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30305975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The current health care crisis in the United States compels a consideration of the crucial role that telemedicine could play towards deploying a pragmatic solution. The nation faces rising costs and difficulties in access to and quality of medical services. Telemedicine can potentially help to overcome these challenges, as it can provide new cost-effective and efficient methods of delivering health care across geographic distances. The full benefits and future potential of telemedicine, however, are constrained by overlapping, inconsistent, and inadequate legal and regulatory frameworks, as well as the repertoire of standards imposed by state governments and professional organizations. Proponents of these barriers claim that they are necessary to protect public health and safety, and that the U.S. Constitution gives states exclusive authority over health and safety concerns. This Article argues that such barriers not only fail to advance these public policy goals, but are unconstitutional when they restrict the practice of telemedicine across state and national borders. Furthermore, the interstate and international nature of telemedicine calls for increasing the centralized authority of the federal government; this position is consistent with the U.S. Constitution and other governing principles. Finally, this Article observes that the U.S. experience bears some similarities to that of other nations, and represents a microcosm of the international community's need and struggle to develop a uniform telemedicine regime. Just as with state governments in the U.S., nations are no longer able to view health care as a traditional domestic concern and must consider nontraditional options to resolve the dilemmas of rising costs and discontent in the delivery of health care to their people.
{"title":"The constitutionality of current legal barriers to telemedicine in the United States: analysis and future directions of its relationship to national and international health care reform.","authors":"Amar Gupta, Deth Sao","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The current health care crisis in the United States compels a consideration of the crucial role that telemedicine could play towards deploying a pragmatic solution. The nation faces rising costs and difficulties in access to and quality of medical services. Telemedicine can potentially help to overcome these challenges, as it can provide new cost-effective and efficient methods of delivering health care across geographic distances. The full benefits and future potential of telemedicine, however, are constrained by overlapping, inconsistent, and inadequate legal and regulatory frameworks, as well as the repertoire of standards imposed by state governments and professional organizations. Proponents of these barriers claim that they are necessary to protect public health and safety, and that the U.S. Constitution gives states exclusive authority over health and safety concerns. This Article argues that such barriers not only fail to advance these public policy goals, but are unconstitutional when they restrict the practice of telemedicine across state and national borders. Furthermore, the interstate and international nature of telemedicine calls for increasing the centralized authority of the federal government; this position is consistent with the U.S. Constitution and other governing principles. Finally, this Article observes that the U.S. experience bears some similarities to that of other nations, and represents a microcosm of the international community's need and struggle to develop a uniform telemedicine regime. Just as with state governments in the U.S., nations are no longer able to view health care as a traditional domestic concern and must consider nontraditional options to resolve the dilemmas of rising costs and discontent in the delivery of health care to their people.</p>","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"21 2","pages":"385-442"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30306055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}