In the midst of an historic election, with the Supreme Court considering another existential chal... more In the midst of an historic election, with the Supreme Court considering another existential challenge to the Affordable Care Act (ACA) and with the nation plunged into a public health and economic crisis from the 2020 coronavirus pandemic, the ACA is as important as ever. The ACA matters. It matters to many millions who count on its protections to access health coverage, particularly as they lose their job-based insurance in the pandemic. It matters to voters and to their representatives tasked with the next generation of health reform. It matters to states, the health care industry, and businesses who have sunk innumerable resources and time into making the ACA work. The Trillion Dollar Revolution assesses the ACA at 10 years, marking its achievements, trade-offs, shortfalls, impacts, and lessons for future reforms. The ACA was both monumental and paradoxical. It was the single biggest social welfare legislation enacted in 50 years and touched every aspect of our sprawling health care system. Yet the narrow political window for its passage meant that the ACA was incremental, building on, rather than fundamentally restructuring, our fragmented health care system. The ACA was imperfect because it inherited many flaws of the existing health care system. Nevertheless, the ACA achieved something quite revolutionary—it changed the minds of the American public, who have since embraced notions of health care access as a right and preexisting condition protections as a given. Edited by Ezekiel Emanuel and Abbe Gluck, the book reads like an insider’s account and assessment of the ACA. The contributors are a veritable Who’s Who of lawyers, health law scholars, health economists, health policy experts, and political leaders with a front-row view of the ACA. Divided into five parts, the essays discuss the ACA’s (I) policy goals, (II) implementation, (III) legal challenges, (IV) impacts, and (V) lessons for the future. The book is well suited for health law and policy students in college or graduatelevel courses, as well as for academics, journalists, health policymakers, and wonks. Fittingly, the book opens with a chapter by Timothy Stoltzfus Jost and John McDonough, perhaps the two most knowledgeable individuals in the country about the law and policy of the ACA. This chapter could stand by itself for its concise history of the ACA, what drove it, what it did, what worked, and what it did not do. Historians and policy scholars will appreciate the first-person accounts of the difficult trade-offs in passage and challenges of implementation by those who were in the room where it happened, including Kathleen Sebelius, who was the Secretary of Health & Human Services for the passage and implementation; Nancy-Ann DePearle, senior health policy advisor to President Obama; Peter Orszag, the director of the Office of
This Viewpoint examines the recent decision by a federal district court that undercuts the Afford... more This Viewpoint examines the recent decision by a federal district court that undercuts the Affordable Care Act’s mandate for cost-free coverage of preventive services, including contraception, some vaccinations, many screenings, and preexposure prophylaxis for HIV, among others.
This Viewpoint discusses a recent federal court decision that invaliated the Food and Drug Admini... more This Viewpoint discusses a recent federal court decision that invaliated the Food and Drug Administration’s (FDA) approval of mifepristone, a drug used to end pregnancies and manage miscarriage when used with misoprostol, and how that decision challenges the legitimacy and independence of the FDA.
Objectives: 1 Compare recent palliative care state policies adopted by different states 2 Assess ... more Objectives: 1 Compare recent palliative care state policies adopted by different states 2 Assess the transferability of other states' palliative care policies to a provider's own state Original Research Background: In the United States, there are significant opportunities to advance palliative care (PC) access and quality at the state level Recently, there has been a rise in PC policies, many of which have stemmed from increased state-level advocacy by palliative care champions Research Objectives: In collaboration with the Center to Advance Palliative Care, the Palliative Care State Policy GPS was created to support research on palliative care policy and to encourage policy innovation aimed at ameliorating disparities in access and reforming palliative care quality and education Methods: Three individuals searched LexisNexis and state health departments with search terms including “palliative care,” “home care,” “home and community-based services,” and “pain management” to find enacted and pending policies that affect PC for each state The database will be automatically updated with new legislation and regulations by periodic input of our search terms into a search function on Westlaw Results: Preliminary data have been collected for thirteen states, the U S territories, and the Indian Health Service The database is expected to be publicly accessible by November 1, 2020 Current data shows heterogeneity among states regarding PC policy Some states, such as New York, have been active in legislating around PC, while other states and territories have lagged In 2019 and 2020, 56 state laws and regulations have been enacted or proposed in seven states (New York, Utah, Texas, Louisiana, Michigan, Oregon, and Vermont) Additionally, the COVID-19 pandemic has encouraged policymaking in telemedicine and expansion of the PC workforce, both of which have positive implications for PC Conclusion and Implications for Research, Policy, or Practice: The creation of the Palliative Care State Policy GPS is critical to understanding how states are adopting PC policies over time, identifying barriers to policy adoption, and developing strategies to improve quality and access to PC
The Schoolhouse Rock! cartoon version of the conventional legislative process is dead, if it was ... more The Schoolhouse Rock! cartoon version of the conventional legislative process is dead, if it was ever an accurate description in the first place. Major policy today is often the product of “unorthodox lawmaking” and “unorthodox rulemaking” — deviations from traditional process marked by frequent use of omnibus bills and multiple agency implementation; emergency statutes and regulations issued without prior comment; outsourcing to lawmaking commissions and unconventional delegates; process shortcuts outside of emergencies; presidential policymaking; and outside drafters, some nonpartisan and others hyperpartisan. These unorthodoxies are everywhere, and they have shifted the balance in the elected branches and beyond, often centralizing power in actors — like party leadership and the White House — not traditionally part of the core lawmaking and rulemaking processes. These unorthodoxies are the new textbook process.The theories and doctrines of legislation and administrative law, howe...
Most of the current debates over adding a mandatory legislation-administration course to the law ... more Most of the current debates over adding a mandatory legislation-administration course to the law school curriculum rightly focus on the need for and value of such a course, or on what traditional core course(s) the so-called "leg-reg" course might replace. Less often investigated, however-and the subject of this article-is the question of how "leg-reg" might affect preexisting or future upper-level offerings in legislation and administrative law. Also rarely probed is the question of whether the impact on the two fields is the same. Given that legislation is the younger and less-entrenched field, this author has long wondered whether the recently developed upper-level legislation course "survives" leg-reg to the same degree that upper-level administrative law may survive. If it does not, one has to evaluate whether reaching more students through leg-reg is worth what may be lost in the reduction of more complex upper-level offerings. These questions sho...
Over the past 50 years, multidistrict litigation (MDL) has quietly revolutionized civil procedure... more Over the past 50 years, multidistrict litigation (MDL) has quietly revolutionized civil procedure. MDLs include the largest tort cases in U.S. history, but without the authority of the class-action rule, MDL judges—who formally have only pretrial jurisdiction over individual cases—have resorted to extraordinary procedural exceptionalism to settle cases on a national scale. Substantive state laws, personal jurisdiction, transparency, impartiality, reviewability, federalism, and adequate representation must all yield if doing so fulfills that one goal. Somehow, until now, this has remained below the surface to everyone but MDL insiders. Thanks to the sprawling MDL over the opioid crisis—and unprecedented opposition to it—MDL is finally in public view. State attorneys general have resisted the opioid MDL’s intense nationalism, its relentless drive to global settlement, its wild procedural innovation, its blurring of differences across state law, and its dramatic assertions of jurisdict...
Excessive prescribing of pain medications after surgery has contributed to the epidemic of opioid... more Excessive prescribing of pain medications after surgery has contributed to the epidemic of opioid misuse and diversion in the United States. Pain specialists may be particularly well situated to address these issues. We describe an attempt to reverse the trend at an orthopedic surgical hospital by implementing a peri-operative assessment and treatment service which minimizes preoperative opioid use, when necessary implements addiction treatment, and encourages early tapering from opioids.
In June 2017, the Supreme Court issued its first decision concerning follow-on biologics—lower-co... more In June 2017, the Supreme Court issued its first decision concerning follow-on biologics—lower-cost versions of innovator biologics—ruling 9-0 in Sandoz v Amgen.1 The decision ruled that follow-on biologic companies are not required to share their licensing application with the innovator company and that a required 180day notice to the innovator company before commercial marketing could be given before US Food and Drug Administration (FDA) approval of their product. This handed the nascent follow-on biologics industry a substantial, albeit incomplete victory, which may help reduce prices and improve patient access to biologic therapies.
Professor Gillian Metzger: Katherine, thank you for that wonderful overview of all that the Justi... more Professor Gillian Metzger: Katherine, thank you for that wonderful overview of all that the Justice has achieved and the history of Columbia Law School. And I want to apologize for those to whom I am showing my back, but this will allow us to have more of a conversation with the Justice. Justice, thank you so much for being with us today. It is a real privilege for us to get to talk to you this way, and we know for the entire audience. You have had-as you have now heard (LAUGHS)-an amazing and just tremendously varied career, spanning so many different roles of academic, public interest advocate, judge, now Justice. We can't possibly cover all of this in the time we have this morning, but what we are hoping to do is talk a little bit about each of these roles, how each step you took influenced the rest, and then we will be throwing it open after our conversation for questions from the audience.
The formalist project in statutory interpretation, as it has defined itself, has been a failure. ... more The formalist project in statutory interpretation, as it has defined itself, has been a failure. That project — typified by but not limited to Justice Antonin Scalia’s brand of textualism — has been doomed because even its staunchest supporters have been unwilling to carry it out. The rules that judges employ are too numerous to be predictably chosen. There is no ranking among them. They are not treated as blackletter, precedential law. Even formalist-textualist judges, it turns out, crave interpretive flexibility, do not want to be controlled by other courts or Congress, and feel the need to show their interpretive actions are democratically linked to Congress. What we actually have instead is an approach whose legitimacy depends, in large part, on understanding how Congress works. Establishing the incomplete execution of formalism is a crucial first step in this argument, because the fiction that textualism has been successful in achieving its goals has prevented us from seeing wh...
In the midst of an historic election, with the Supreme Court considering another existential chal... more In the midst of an historic election, with the Supreme Court considering another existential challenge to the Affordable Care Act (ACA) and with the nation plunged into a public health and economic crisis from the 2020 coronavirus pandemic, the ACA is as important as ever. The ACA matters. It matters to many millions who count on its protections to access health coverage, particularly as they lose their job-based insurance in the pandemic. It matters to voters and to their representatives tasked with the next generation of health reform. It matters to states, the health care industry, and businesses who have sunk innumerable resources and time into making the ACA work. The Trillion Dollar Revolution assesses the ACA at 10 years, marking its achievements, trade-offs, shortfalls, impacts, and lessons for future reforms. The ACA was both monumental and paradoxical. It was the single biggest social welfare legislation enacted in 50 years and touched every aspect of our sprawling health care system. Yet the narrow political window for its passage meant that the ACA was incremental, building on, rather than fundamentally restructuring, our fragmented health care system. The ACA was imperfect because it inherited many flaws of the existing health care system. Nevertheless, the ACA achieved something quite revolutionary—it changed the minds of the American public, who have since embraced notions of health care access as a right and preexisting condition protections as a given. Edited by Ezekiel Emanuel and Abbe Gluck, the book reads like an insider’s account and assessment of the ACA. The contributors are a veritable Who’s Who of lawyers, health law scholars, health economists, health policy experts, and political leaders with a front-row view of the ACA. Divided into five parts, the essays discuss the ACA’s (I) policy goals, (II) implementation, (III) legal challenges, (IV) impacts, and (V) lessons for the future. The book is well suited for health law and policy students in college or graduatelevel courses, as well as for academics, journalists, health policymakers, and wonks. Fittingly, the book opens with a chapter by Timothy Stoltzfus Jost and John McDonough, perhaps the two most knowledgeable individuals in the country about the law and policy of the ACA. This chapter could stand by itself for its concise history of the ACA, what drove it, what it did, what worked, and what it did not do. Historians and policy scholars will appreciate the first-person accounts of the difficult trade-offs in passage and challenges of implementation by those who were in the room where it happened, including Kathleen Sebelius, who was the Secretary of Health & Human Services for the passage and implementation; Nancy-Ann DePearle, senior health policy advisor to President Obama; Peter Orszag, the director of the Office of
This Viewpoint examines the recent decision by a federal district court that undercuts the Afford... more This Viewpoint examines the recent decision by a federal district court that undercuts the Affordable Care Act’s mandate for cost-free coverage of preventive services, including contraception, some vaccinations, many screenings, and preexposure prophylaxis for HIV, among others.
This Viewpoint discusses a recent federal court decision that invaliated the Food and Drug Admini... more This Viewpoint discusses a recent federal court decision that invaliated the Food and Drug Administration’s (FDA) approval of mifepristone, a drug used to end pregnancies and manage miscarriage when used with misoprostol, and how that decision challenges the legitimacy and independence of the FDA.
Objectives: 1 Compare recent palliative care state policies adopted by different states 2 Assess ... more Objectives: 1 Compare recent palliative care state policies adopted by different states 2 Assess the transferability of other states' palliative care policies to a provider's own state Original Research Background: In the United States, there are significant opportunities to advance palliative care (PC) access and quality at the state level Recently, there has been a rise in PC policies, many of which have stemmed from increased state-level advocacy by palliative care champions Research Objectives: In collaboration with the Center to Advance Palliative Care, the Palliative Care State Policy GPS was created to support research on palliative care policy and to encourage policy innovation aimed at ameliorating disparities in access and reforming palliative care quality and education Methods: Three individuals searched LexisNexis and state health departments with search terms including “palliative care,” “home care,” “home and community-based services,” and “pain management” to find enacted and pending policies that affect PC for each state The database will be automatically updated with new legislation and regulations by periodic input of our search terms into a search function on Westlaw Results: Preliminary data have been collected for thirteen states, the U S territories, and the Indian Health Service The database is expected to be publicly accessible by November 1, 2020 Current data shows heterogeneity among states regarding PC policy Some states, such as New York, have been active in legislating around PC, while other states and territories have lagged In 2019 and 2020, 56 state laws and regulations have been enacted or proposed in seven states (New York, Utah, Texas, Louisiana, Michigan, Oregon, and Vermont) Additionally, the COVID-19 pandemic has encouraged policymaking in telemedicine and expansion of the PC workforce, both of which have positive implications for PC Conclusion and Implications for Research, Policy, or Practice: The creation of the Palliative Care State Policy GPS is critical to understanding how states are adopting PC policies over time, identifying barriers to policy adoption, and developing strategies to improve quality and access to PC
The Schoolhouse Rock! cartoon version of the conventional legislative process is dead, if it was ... more The Schoolhouse Rock! cartoon version of the conventional legislative process is dead, if it was ever an accurate description in the first place. Major policy today is often the product of “unorthodox lawmaking” and “unorthodox rulemaking” — deviations from traditional process marked by frequent use of omnibus bills and multiple agency implementation; emergency statutes and regulations issued without prior comment; outsourcing to lawmaking commissions and unconventional delegates; process shortcuts outside of emergencies; presidential policymaking; and outside drafters, some nonpartisan and others hyperpartisan. These unorthodoxies are everywhere, and they have shifted the balance in the elected branches and beyond, often centralizing power in actors — like party leadership and the White House — not traditionally part of the core lawmaking and rulemaking processes. These unorthodoxies are the new textbook process.The theories and doctrines of legislation and administrative law, howe...
Most of the current debates over adding a mandatory legislation-administration course to the law ... more Most of the current debates over adding a mandatory legislation-administration course to the law school curriculum rightly focus on the need for and value of such a course, or on what traditional core course(s) the so-called "leg-reg" course might replace. Less often investigated, however-and the subject of this article-is the question of how "leg-reg" might affect preexisting or future upper-level offerings in legislation and administrative law. Also rarely probed is the question of whether the impact on the two fields is the same. Given that legislation is the younger and less-entrenched field, this author has long wondered whether the recently developed upper-level legislation course "survives" leg-reg to the same degree that upper-level administrative law may survive. If it does not, one has to evaluate whether reaching more students through leg-reg is worth what may be lost in the reduction of more complex upper-level offerings. These questions sho...
Over the past 50 years, multidistrict litigation (MDL) has quietly revolutionized civil procedure... more Over the past 50 years, multidistrict litigation (MDL) has quietly revolutionized civil procedure. MDLs include the largest tort cases in U.S. history, but without the authority of the class-action rule, MDL judges—who formally have only pretrial jurisdiction over individual cases—have resorted to extraordinary procedural exceptionalism to settle cases on a national scale. Substantive state laws, personal jurisdiction, transparency, impartiality, reviewability, federalism, and adequate representation must all yield if doing so fulfills that one goal. Somehow, until now, this has remained below the surface to everyone but MDL insiders. Thanks to the sprawling MDL over the opioid crisis—and unprecedented opposition to it—MDL is finally in public view. State attorneys general have resisted the opioid MDL’s intense nationalism, its relentless drive to global settlement, its wild procedural innovation, its blurring of differences across state law, and its dramatic assertions of jurisdict...
Excessive prescribing of pain medications after surgery has contributed to the epidemic of opioid... more Excessive prescribing of pain medications after surgery has contributed to the epidemic of opioid misuse and diversion in the United States. Pain specialists may be particularly well situated to address these issues. We describe an attempt to reverse the trend at an orthopedic surgical hospital by implementing a peri-operative assessment and treatment service which minimizes preoperative opioid use, when necessary implements addiction treatment, and encourages early tapering from opioids.
In June 2017, the Supreme Court issued its first decision concerning follow-on biologics—lower-co... more In June 2017, the Supreme Court issued its first decision concerning follow-on biologics—lower-cost versions of innovator biologics—ruling 9-0 in Sandoz v Amgen.1 The decision ruled that follow-on biologic companies are not required to share their licensing application with the innovator company and that a required 180day notice to the innovator company before commercial marketing could be given before US Food and Drug Administration (FDA) approval of their product. This handed the nascent follow-on biologics industry a substantial, albeit incomplete victory, which may help reduce prices and improve patient access to biologic therapies.
Professor Gillian Metzger: Katherine, thank you for that wonderful overview of all that the Justi... more Professor Gillian Metzger: Katherine, thank you for that wonderful overview of all that the Justice has achieved and the history of Columbia Law School. And I want to apologize for those to whom I am showing my back, but this will allow us to have more of a conversation with the Justice. Justice, thank you so much for being with us today. It is a real privilege for us to get to talk to you this way, and we know for the entire audience. You have had-as you have now heard (LAUGHS)-an amazing and just tremendously varied career, spanning so many different roles of academic, public interest advocate, judge, now Justice. We can't possibly cover all of this in the time we have this morning, but what we are hoping to do is talk a little bit about each of these roles, how each step you took influenced the rest, and then we will be throwing it open after our conversation for questions from the audience.
The formalist project in statutory interpretation, as it has defined itself, has been a failure. ... more The formalist project in statutory interpretation, as it has defined itself, has been a failure. That project — typified by but not limited to Justice Antonin Scalia’s brand of textualism — has been doomed because even its staunchest supporters have been unwilling to carry it out. The rules that judges employ are too numerous to be predictably chosen. There is no ranking among them. They are not treated as blackletter, precedential law. Even formalist-textualist judges, it turns out, crave interpretive flexibility, do not want to be controlled by other courts or Congress, and feel the need to show their interpretive actions are democratically linked to Congress. What we actually have instead is an approach whose legitimacy depends, in large part, on understanding how Congress works. Establishing the incomplete execution of formalism is a crucial first step in this argument, because the fiction that textualism has been successful in achieving its goals has prevented us from seeing wh...
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