Does the recently enacted Federal Right-to-Try Act provide improved access for the desperately ill? Will insurance companies provide reimbursement for a patient to undergo such investigational therapies? Is the manufacturer protected in terms of lawsuits? That is, does the patient relinquish the right to bring a legal action? Will physicians comprehend the pathway and advocate for their patients? Does this new law guarantee “any novel federal right”? The national state movement regarding Right-to-Try state legislation spurred the enactment of the Federal Right-to-Try (Federal Right-to-Try Act) legislation passed in 2018. Yet, even prior to the enactment of the Federal Right-to-Try law, the United States Federal Food and Drug Administration (FDA) has had mechanisms in place for those terminally ill who do not qualify for a clinical trial. This article provides a Federal Primer on the Investigational Drug, Biologic and Device Process, details a similar national right-to-know movement in the food and drug law arena that led to federal legislation perhaps comparable to how the Federal Right-to-Try Act was enacted and includes a discussion about the state right to try movement which conceivably led to the enactment of the Federal Right-to-Try Act. There are more queries than unambiguous answers regarding the recently enacted Federal Right-to-Try Act. The federal law in essence could prove troublesome and confusing with both the state Right-to-Try measures due to, for instance, issues of national uniformity and preemption. Further, could the recently enacted Federal Right-to-Try Act ultimately be detrimental to the patient in terms of lack of adequate safeguards and perhaps a false unrealistic sense of hope?
{"title":"The Latest \"Federal Movement\" in the Food and Drug Law Arena: The Federal Right-to-Try or Rather Right-to-Know and Thus Request Investigational Therapies for Individuals with a Life-Threatening Disease or Condition","authors":"R. Termini","doi":"10.18060/3911.0056","DOIUrl":"https://doi.org/10.18060/3911.0056","url":null,"abstract":"Does the recently enacted Federal Right-to-Try Act provide improved access for the desperately ill? Will insurance companies provide reimbursement for a patient to undergo such investigational therapies? Is the manufacturer protected in terms of lawsuits? That is, does the patient relinquish the right to bring a legal action? Will physicians comprehend the pathway and advocate for their patients? Does this new law guarantee “any novel federal right”? The national state movement regarding Right-to-Try state legislation spurred the enactment of the Federal Right-to-Try (Federal Right-to-Try Act) legislation passed in 2018. Yet, even prior to the enactment of the Federal Right-to-Try law, the United States Federal Food and Drug Administration (FDA) has had mechanisms in place for those terminally ill who do not qualify for a clinical trial. \u0000 \u0000This article provides a Federal Primer on the Investigational Drug, Biologic and Device Process, details a similar national right-to-know movement in the food and drug law arena that led to federal legislation perhaps comparable to how the Federal Right-to-Try Act was enacted and includes a discussion about the state right to try movement which conceivably led to the enactment of the Federal Right-to-Try Act. There are more queries than unambiguous answers regarding the recently enacted Federal Right-to-Try Act. The federal law in essence could prove troublesome and confusing with both the state Right-to-Try measures due to, for instance, issues of national uniformity and preemption. Further, could the recently enacted Federal Right-to-Try Act ultimately be detrimental to the patient in terms of lack of adequate safeguards and perhaps a false unrealistic sense of hope?","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45753504","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}
It is not uncommon to read that long-held beliefs about medical treatments have been dislodged by new studies. For example, there is now doubt as to whether women should undergo annual mammograms, previously a cornerstone of cancer screening. Hormone replacement therapy for menopausal women, once considered highly suspect in light of worrisome research findings, is now being reconsidered as a beneficial therapy. These reversals trouble and confuse many Americans. This Article explores why medical research findings can be erroneous and what can go wrong in the process of designing and conducting research studies. It provides readers with essential analytical tools and scientific vocabulary. The challenges of medical research include data quality deficiencies; selection, confounding, measurement, and confirmation biases; inadequate sample sizes; sampling errors; effect modifiers; and causal interactions, among others. All of these can cause researchers to mistake mere associations for causal relationships and to reach conclusions that are invalid and cannot be replicated in subsequent studies. Erroneous research findings can mislead legislators, regulators, and lawyers who use them for purposes of policy-making or litigation. Thus, understanding the pitfalls of big data analysis is important not only for scientists but also for anyone working with or reading about research studies, that is, for attorneys, health policy professionals, and the public at large.
{"title":"Big Data Analytics","authors":"S. Hoffman","doi":"10.18060/3911.0048","DOIUrl":"https://doi.org/10.18060/3911.0048","url":null,"abstract":"It is not uncommon to read that long-held beliefs about medical treatments have been dislodged by new studies. For example, there is now doubt as to whether women should undergo annual mammograms, previously a cornerstone of cancer screening. Hormone replacement therapy for menopausal women, once considered highly suspect in light of worrisome research findings, is now being reconsidered as a beneficial therapy. These reversals trouble and confuse many Americans. \u0000This Article explores why medical research findings can be erroneous and what can go wrong in the process of designing and conducting research studies. It provides readers with essential analytical tools and scientific vocabulary. The challenges of medical research include data quality deficiencies; selection, confounding, measurement, and confirmation biases; inadequate sample sizes; sampling errors; effect modifiers; and causal interactions, among others. All of these can cause researchers to mistake mere associations for causal relationships and to reach conclusions that are invalid and cannot be replicated in subsequent studies. \u0000Erroneous research findings can mislead legislators, regulators, and lawyers who use them for purposes of policy-making or litigation. Thus, understanding the pitfalls of big data analysis is important not only for scientists but also for anyone working with or reading about research studies, that is, for attorneys, health policy professionals, and the public at large.","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43143960","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":"What Motivates Legislators to Act:","authors":"Taleed El-Sabawi","doi":"10.18060/3911.0047","DOIUrl":"https://doi.org/10.18060/3911.0047","url":null,"abstract":"","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44047970","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":"Collateral Consequences and the Right to Appeal","authors":"Jonathan B. Warner","doi":"10.18060/3911.0050","DOIUrl":"https://doi.org/10.18060/3911.0050","url":null,"abstract":"","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44716649","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}
In introducing his Special Issue, the guest-editor identifies different usages of the term 'UPE' , also reflected in the contributions to the Issue, and comments on the implications of this diversity in the context of nations' efforts to achieve it. 'Real ' and 'bogus' UPE are distinguished and the alternative concept of basic education considered. Implementation of UPE, an immensely demanding undertaking, requires adequate information, genuine commitment and close co-operation at all levels and from all concerned; equally, it depends on administrative ability, organization of training, and political motivation, flexibility and sincerity. Recognising the demands and costs of UPE, the reasons for commitment to it are examined (and illustrated from the case of Nigeria) and the feasibility of successful implementation, e.g., by the year 2000, assessed. Alternatives exist, both in concept and practice, but seem unlikely to commend themselves. Nevertheless, as is stressed in the articles, lessons may be learned from experience already gained concerning the effectiveness of such factors as: greater community involvement in providing and controlling schools; more emphasis on school health; closer relationships between central and local planning; alternative structures for older learners or drop-outs; the shortening of instructional time; and increased research and greater investment in training for the teaching of basic skills at primary level. Without a radical change of attitude, particularly with respect to this last priority, efforts to achieve even literacy, the first goal of UPE, are being seriously undermined. Zusammenfassung In seiner Einleitung zu dieser Sondernummer zeigt der Gastherausgeber die verschiedenen Definitionen des Begriffes des 'Weltweiten Ausbaus des Primarschulwesens' auf, die auch in den Beitr~igen dieser Ausgabe gebraucht werden. Danach erl~iutert er die Bedeutung dieser Vielfalt im Rahmen der Bemiihungen der Staaten, dieses Ziel zu erreichen. Es wird zwischen 'echten' und 'gef~ilschten' Konzepten des weltweiten Ausbaus des Primarschulwesens unterschieden und die Alternative eines Konzepts der Elementarerziehung wird erwogen. Die DurchfOhrung des weltweiten Ausbaus des Primarschulwesens ein tiberaus anspruchsvolles Unternehmen erfordert angemessene Information, wahres Engagement und eine enge Zusammenarbeit auf allen Ebenen und von allen Betroffenen; sie h~ingt gleichermaf~en von administrativen F~ihigkeiten, der Organisation der Ausbildung sowie politischer Motivation, als auch Flexibilit~it und Ernsthaftigkeit ab. Die Nachfragen und Kosten des weltweiten Ausbaus der Primarerziehung werden erkannt, die Grtinde ftir ein entsprechendes Engagement werden untersucht (und an Hand des Beispiels von Nigerien illustriert) undes wird gepriift, ob sich dieses Ziel bis zum Jahre 2000 erfolgreich durchftihren l~il3t. Alternativen bestehen zwar, sowohl als Konzept wie auch in Praxis, aber es erscheint unwahrscheinlich, dab sie sich anbiete
{"title":"Once More Unto the Breach","authors":"Connor McLarren","doi":"10.18060/3911.0051","DOIUrl":"https://doi.org/10.18060/3911.0051","url":null,"abstract":"In introducing his Special Issue, the guest-editor identifies different usages of the term 'UPE' , also reflected in the contributions to the Issue, and comments on the implications of this diversity in the context of nations' efforts to achieve it. 'Real ' and 'bogus' UPE are distinguished and the alternative concept of basic education considered. Implementation of UPE, an immensely demanding undertaking, requires adequate information, genuine commitment and close co-operation at all levels and from all concerned; equally, it depends on administrative ability, organization of training, and political motivation, flexibility and sincerity. Recognising the demands and costs of UPE, the reasons for commitment to it are examined (and illustrated from the case of Nigeria) and the feasibility of successful implementation, e.g., by the year 2000, assessed. Alternatives exist, both in concept and practice, but seem unlikely to commend themselves. Nevertheless, as is stressed in the articles, lessons may be learned from experience already gained concerning the effectiveness of such factors as: greater community involvement in providing and controlling schools; more emphasis on school health; closer relationships between central and local planning; alternative structures for older learners or drop-outs; the shortening of instructional time; and increased research and greater investment in training for the teaching of basic skills at primary level. Without a radical change of attitude, particularly with respect to this last priority, efforts to achieve even literacy, the first goal of UPE, are being seriously undermined. Zusammenfassung In seiner Einleitung zu dieser Sondernummer zeigt der Gastherausgeber die verschiedenen Definitionen des Begriffes des 'Weltweiten Ausbaus des Primarschulwesens' auf, die auch in den Beitr~igen dieser Ausgabe gebraucht werden. Danach erl~iutert er die Bedeutung dieser Vielfalt im Rahmen der Bemiihungen der Staaten, dieses Ziel zu erreichen. Es wird zwischen 'echten' und 'gef~ilschten' Konzepten des weltweiten Ausbaus des Primarschulwesens unterschieden und die Alternative eines Konzepts der Elementarerziehung wird erwogen. Die DurchfOhrung des weltweiten Ausbaus des Primarschulwesens ein tiberaus anspruchsvolles Unternehmen erfordert angemessene Information, wahres Engagement und eine enge Zusammenarbeit auf allen Ebenen und von allen Betroffenen; sie h~ingt gleichermaf~en von administrativen F~ihigkeiten, der Organisation der Ausbildung sowie politischer Motivation, als auch Flexibilit~it und Ernsthaftigkeit ab. Die Nachfragen und Kosten des weltweiten Ausbaus der Primarerziehung werden erkannt, die Grtinde ftir ein entsprechendes Engagement werden untersucht (und an Hand des Beispiels von Nigerien illustriert) undes wird gepriift, ob sich dieses Ziel bis zum Jahre 2000 erfolgreich durchftihren l~il3t. Alternativen bestehen zwar, sowohl als Konzept wie auch in Praxis, aber es erscheint unwahrscheinlich, dab sie sich anbiete","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48342964","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 United States is in the midst of a historic public health crisis. Each day, well over 100 Americans die of drug overdose, driven increasingly by street opioids. In line with other “epidemics” of grave public concern, this crisis has spurred an expansion of public health surveillance. This article focuses on the principal element of this expansion—prescription drug monitoring programs (PDMPs). By collecting information on who is prescribing, dispensing, and receiving scheduled drugs, PDMPs are intended to detect—and deter—problem patients, rogue prescribers, and pharmacists who may be diverting potentially addictive and otherwise risky drugs. PDMPs are far from new, but the recent scale-up in the number, scope, funding, and legal mandates of these systems has occurred without sufficient scrutiny. The lens of public health law research has just begun to be trained on PDMPs. By integrating empirical and theoretical perspectives, this article adds to this nescient discourse. I argue that the zeal with which we have traditionally pursued supply reduction measures to address drug-related harms reflects the legal and system design of PDMPs, as well as the street-level implementation of these programs. This also explains why the success of PDMPs has been measured primarily by their impact on suppressing medication supply with little regard for truly meaningful metrics. But, when it comes to improving patient care and addressing drug-related harms, the evidence of PDMP benefit is far from clear. This article presents a narrative review of the 34 peer-reviewed studies evaluating PDMPs published since 2010. Only 11 (32%) considered any overdose outcomes. Of studies assessing overall mortality, three found PDMP deployment to be associated with reduced overdose rates, four reported a null result, and three reported PDMPs to be associated with an increase in overdoses. These findings stand to challenge the kind of unbridled enthusiasm, generous investment, and cavalier policy emphasis that has buoyed PDMPs since the onset of the overdose crisis. Given evidence of mixed impact, the unintended harms of these systems warrant urgent examination. This includes their potential role in deterring proper prescribing practices; chilling help-seeking among patients, especially those made vulnerable by a history of trauma in the healthcare settings and criminal justice involvement; further fraying the fabric of provider-patient trust; and facilitating patient transition from prescription to black market drug supplies. Original qualitative data presented here give voice to stakeholder concerns about surveillance, privacy, and pervasive monitoring by law enforcement. A special focus on privacy is especially timely in view of recent appellate decisions allowing broad warrantless disclosure of PDMP data to law enforcement. Although the perils of expansive government monitoring and predictive technologies are recognized in national security, criminal justice, and other re
{"title":"Deploying Prescription Drug Monitoring to Address the Overdose Crisis","authors":"L. Beletsky","doi":"10.18060/3911.0046","DOIUrl":"https://doi.org/10.18060/3911.0046","url":null,"abstract":"The United States is in the midst of a historic public health crisis. Each day, well over 100 Americans die of drug overdose, driven increasingly by street opioids. In line with other “epidemics” of grave public concern, this crisis has spurred an expansion of public health surveillance. This article focuses on the principal element of this expansion—prescription drug monitoring programs (PDMPs). By collecting information on who is prescribing, dispensing, and receiving scheduled drugs, PDMPs are intended to detect—and deter—problem patients, rogue prescribers, and pharmacists who may be diverting potentially addictive and otherwise risky drugs. \u0000PDMPs are far from new, but the recent scale-up in the number, scope, funding, and legal mandates of these systems has occurred without sufficient scrutiny. The lens of public health law research has just begun to be trained on PDMPs. By integrating empirical and theoretical perspectives, this article adds to this nescient discourse. I argue that the zeal with which we have traditionally pursued supply reduction measures to address drug-related harms reflects the legal and system design of PDMPs, as well as the street-level implementation of these programs. This also explains why the success of PDMPs has been measured primarily by their impact on suppressing medication supply with little regard for truly meaningful metrics. But, when it comes to improving patient care and addressing drug-related harms, the evidence of PDMP benefit is far from clear. This article presents a narrative review of the 34 peer-reviewed studies evaluating PDMPs published since 2010. Only 11 (32%) considered any overdose outcomes. Of studies assessing overall mortality, three found PDMP deployment to be associated with reduced overdose rates, four reported a null result, and three reported PDMPs to be associated with an increase in overdoses. These findings stand to challenge the kind of unbridled enthusiasm, generous investment, and cavalier policy emphasis that has buoyed PDMPs since the onset of the overdose crisis. Given evidence of mixed impact, the unintended harms of these systems warrant urgent examination. This includes their potential role in deterring proper prescribing practices; chilling help-seeking among patients, especially those made vulnerable by a history of trauma in the healthcare settings and criminal justice involvement; further fraying the fabric of provider-patient trust; and facilitating patient transition from prescription to black market drug supplies. Original qualitative data presented here give voice to stakeholder concerns about surveillance, privacy, and pervasive monitoring by law enforcement. A special focus on privacy is especially timely in view of recent appellate decisions allowing broad warrantless disclosure of PDMP data to law enforcement. Although the perils of expansive government monitoring and predictive technologies are recognized in national security, criminal justice, and other re","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43256215","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":"From [A]nthrax to [Z]ika","authors":"J. Hodge, Lexi C. White, Sarah A. Wetter","doi":"10.18060/3911.0042","DOIUrl":"https://doi.org/10.18060/3911.0042","url":null,"abstract":"","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46821826","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":"Financial Conflicts in the New Era of Sunshine","authors":"R. S. Saver","doi":"10.18060/3911.0044","DOIUrl":"https://doi.org/10.18060/3911.0044","url":null,"abstract":"","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43116751","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":"Indiana's Public Health is in Jeopardy","authors":"H. Reed","doi":"10.18060/3911.0045","DOIUrl":"https://doi.org/10.18060/3911.0045","url":null,"abstract":"","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48859581","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 essay, part of a symposium investigating methods of empirically evaluating health policy, focuses on American health care federalism, the relationship between the federal and state governments in the realm of health care policy and regulation. We describe the results of a five year study of the implementation of the Patient Protection and Affordable Care Act (ACA) from 2012-2017. Our study focused on two key pillars of the ACA, which happen to be its most state-centered — expansion of Medicaid and the implementation of health insurance exchanges — and sheds light on federalism in the modern era of nationally-enacted health laws that preserve key roles for state leadership. The full study is detailed in the Stanford Law Review; here, we offer a more accessible snapshot and highlight a key aspect of the research: interviews of approximately twenty high ranking former state and federal officials at the forefront of ACA implementation. The interviews corroborate the study data and substantiate our conclusions about the defining characteristics of the ACA’s implementation from a federalism perspective. Specifically, we found that the ACA’s implementation process has been 1) dynamic; 2) pragmatic; 3) negotiated; and 4) and marked by intrastate politics. We observed waves of engagement and estrangement between states and the federal government, and state decisions to participate in the ACA’s programs have not been binary, in/out choices. Vertical and horizontal negotiation and copying have been near constants. The findings also reveal theoretical and empirical challenges for quantitatively evaluating health care federalism. Does it exist? Is it successful? We found the traditional federalism attributes pop up in inconsistent ways under the ACA and emerge from virtually every structural arrangement of the law. We tried, for instance, to measure how “cooperative” the states were, only to find that concept meaningless. Some states attempted implementation but failed; other states rebelled by refusing to run their own programs at all. The federal government stepped in for both. Were such states equally “cooperative” or “autonomous”? The same challenges occurred for all of the classic federalism metrics. For example, we saw local experimentation emerge from every kind of governance structure under the ACA, including nationalist ones. Our work leads us to a key question: Why choose federalism-oriented health reform models in the first place? In ACA implementation, it sometimes appeared that federalist arrangements did not aim to improve health outcomes but rather reflected “federalism for federalism’s sake”—federalism to advance political or constitutional values, such as reserving power to the states in the interest of sovereignty and balance of power — regardless of the effect on health care coverage, cost, quality, or other measures of health policy success. At other times, it seems federalism was intended as a means to an end — e.g., that state-le
{"title":"The New Health Care Federalism on the Ground","authors":"Abbe R. Gluck, Nicole Huberfeld","doi":"10.18060/3911.0041","DOIUrl":"https://doi.org/10.18060/3911.0041","url":null,"abstract":"This essay, part of a symposium investigating methods of empirically evaluating health policy, focuses on American health care federalism, the relationship between the federal and state governments in the realm of health care policy and regulation. We describe the results of a five year study of the implementation of the Patient Protection and Affordable Care Act (ACA) from 2012-2017. Our study focused on two key pillars of the ACA, which happen to be its most state-centered — expansion of Medicaid and the implementation of health insurance exchanges — and sheds light on federalism in the modern era of nationally-enacted health laws that preserve key roles for state leadership. The full study is detailed in the Stanford Law Review; here, we offer a more accessible snapshot and highlight a key aspect of the research: interviews of approximately twenty high ranking former state and federal officials at the forefront of ACA implementation. \u0000The interviews corroborate the study data and substantiate our conclusions about the defining characteristics of the ACA’s implementation from a federalism perspective. Specifically, we found that the ACA’s implementation process has been 1) dynamic; 2) pragmatic; 3) negotiated; and 4) and marked by intrastate politics. We observed waves of engagement and estrangement between states and the federal government, and state decisions to participate in the ACA’s programs have not been binary, in/out choices. Vertical and horizontal negotiation and copying have been near constants. \u0000The findings also reveal theoretical and empirical challenges for quantitatively evaluating health care federalism. Does it exist? Is it successful? We found the traditional federalism attributes pop up in inconsistent ways under the ACA and emerge from virtually every structural arrangement of the law. We tried, for instance, to measure how “cooperative” the states were, only to find that concept meaningless. Some states attempted implementation but failed; other states rebelled by refusing to run their own programs at all. The federal government stepped in for both. Were such states equally “cooperative” or “autonomous”? The same challenges occurred for all of the classic federalism metrics. For example, we saw local experimentation emerge from every kind of governance structure under the ACA, including nationalist ones. \u0000Our work leads us to a key question: Why choose federalism-oriented health reform models in the first place? In ACA implementation, it sometimes appeared that federalist arrangements did not aim to improve health outcomes but rather reflected “federalism for federalism’s sake”—federalism to advance political or constitutional values, such as reserving power to the states in the interest of sovereignty and balance of power — regardless of the effect on health care coverage, cost, quality, or other measures of health policy success. At other times, it seems federalism was intended as a means to an end — e.g., that state-le","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42740181","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}
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