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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.

Firearm injury in the United States is a public health crisis in which physicians are uniquely situated to intervene. However, their ability to mitigate harm is limited by a complex array of laws and regulations that shape their role in firearm injury prevention. This piece uses four clinical scenarios to illustrate how these laws and regulations impact physician practice, including patient counseling, injury reporting, and the use of court orders and involuntary holds. Unintended consequences on clinical practice of laws intended to reduce firearm injury are also discussed. Lessons drawn from these cases suggest that physicians require more nuanced education on this topic, and that policymakers should consult front-line healthcare providers when designing firearm policies.

Litigation cannot solve a public health crisis. But litigation can be an effective complementary tool to regulation by increasing the salience of a public health issue, eliciting closely guarded information to move public opinion, and prompting legislative action. From tobacco to opioids, litigants have successfully turned to courts for monetary relief, to initiate systemic change, and to hold industry accountable For years, litigators have been trying to push firearm suits into their own litigation moment. But litigation against the gun industry poses special challenges. Not only has the regulatory regime failed to prevent a public safety hazard, Congress has consistently underfunded and understaffed the relevant regulatory actors. And in 2005 it legislatively immunized the gun industry from suit with the Protection of Lawful Commerce in Arms Act (PLCAA). This paper surveys the field of litigation in response to gun violence, tracking the limited successes of victims and stakeholders suing the gun industry. We find that victories remain confined to individual actors and unlike high-impact public litigations in other areas, aggregate class actions and major public litigation led by state attorneys general are noticeably absent in the firearm context.

The traditional legislative process is dead in the U.S. Statutes are increasingly long and complex omnibus efforts rushed through at the end of congressional sessions. Yet American statutory interpretation remains largely unchanged, with judges generally uninterested in the realities of the legislative process, despite claiming our dominant interpretive approach reflects Congress or is in conversation with it. Omnibus statutes pose challenges for judges who read statutes with assumptions of linguistic perfection and consistency—as American judges do—and the truncated legislative process results in more gaps and mistakes, problems that lack coherent doctrinal approaches in our courts. And American judges have never been willing to strike down federal statutes for lack of deliberation or process, preferring instead indirect nudges toward more “due process in lawmaking.” This chapter documents the rise of unorthodox modern lawmaking in the U.S., including omnibus lawmaking, and details its causes, costs and benefits. These developments are not unmitigated negatives; they are adaptations to the changing complexities of the American political system. It has been 50 years since the last congressional reorganization and another revolution may be coming. There is a burgeoning legal movement among scholars and some American jurists, including several Supreme Court justices, to bring understanding of the legislative process, and how it has changed, into our theories and doctrines of statutory interpretation.

Importance: Trauma is a leading cause of death and disability for patients of all ages, many of whom are also among the most likely to be uninsured. Passage of the Patient Protection and Affordable Care Act was intended to improve access to care through improvements in insurance. However, despite nationally reported changes in the payer mix of patients, the extent of the law’s impact on insurance coverage among trauma patients is unknown, as is its success in improving trauma outcomes and promoting increased access to rehabilitation. Objective: To use rigorous quasi-experimental regression techniques to assess the extent of changes in insurance coverage, outcomes, and discharge to rehabilitation among adult trauma patients before and after Medicaid expansion and implementation of the remainder of the Patient Protection and Affordable Care Act. Design, Setting, and Participants: Quasi-experimental, difference-in-difference analysis assessed adult trauma patients aged 19 to 64 years in 5 Medicaid expansion (Colorado, Illinois, Minnesota, New Jersey, and New Mexico) and 4 nonexpansion (Florida, Nebraska, North Carolina, and Texas) states. Interventions/Exposure: Policy implementation in January 2014. Main Outcomes and Measures: Changes in insurance coverage, outcomes (mortality, morbidity, failure to rescue, and length of stay), and discharge to rehabilitation. Results: A total of 283 878 patients from Medicaid expansion states and 285 851 patients from nonexpansion states were included (mean age [SD], 41.9 [14.1] years; 206 698 [36.3%] women). Adults with injuries in expansion states experienced a 13.7 percentage point decline in uninsured individuals (95% CI, 14.1-13.3; baseline: 22.7%) after Medicaid expansion compared with nonexpansion states. This coincided with a 7.4 percentage point increase in discharge to rehabilitation (95% CI, 7.0-7.8; baseline: 14.7%) that persisted across inpatient rehabilitation facilities (4.5 percentage points), home health agencies (2.9 percentage points), and skilled nursing facilities (1.0 percentage points). There was also a 2.6 percentage point drop in failure to rescue and a 0.84-day increase in average length of stay. Rehabilitation changes were most pronounced among patients eligible for rehabilitation coverage under the 2-midnight (8.4 percentage points) and 60% (10.2 percentage points) Medicaid payment rules. Medicaid expansion increased rehabilitation access for patients with the most severe injuries and conditions requiring postdischarge care (eg, pelvic fracture). It mitigated race/ethnicity–, age-, and sex-based disparities in which patients use rehabilitation. Conclusions and relevance: This multistate assessment demonstrated significant changes in insurance coverage and discharge to rehabilitation among adult trauma patients that were greater in Medicaid expansion than nonexpansion states. By targeting subgroups of the trauma population most likely to be uninsured, rehabilitation gains associated with Medicaid have the potential to improve survival and functional outcomes for more than 60 000 additional adult trauma patients nationally in expansion states.

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-led health policy is assumed to produce better health outcomes. In the end, we were able to conclude more assuredly that the ACA’s many structural arrangements served state power than that any particular one of those arrangements was more federalist or that any particular one produced better health policy. Clearly, we cannot evaluate federalism — whether it exists, whether it is working, whether it is worth defending — without knowing what it is for in the first place.

This article examines five different Medical-Legal Partnerships (MLPs) associated with Yale Law School in New Haven, Connecticut to illustrate how MLP addresses the social determinants of poor health. These MLPs address varied and distinct health and legal needs of unique patient populations, including: 1) children; 2) immigrants; 3) formerly incarcerated individuals; 4) patients with cancer in palliative care; and 5) veterans. The article charts a research agenda to create the evidence base for quality and evaluation metrics, capacity building, sustainability, and best practices; it also focuses specifically on a research agenda that identifies the value of the lawyers in MLP. Such a focus on the “L” has been lacking and is overdue.

The next steps in health reform, like all such efforts before it, will have to engage the issue of American health care federalism – the relationship between the federal and state governments in the realm of health law and policy. Since its enactment in 2010, the Patient Protection and Affordable Care Act (ACA) has offered a robust example of modern federalism and revealed new complexities. This article recounts the findings of our five-year study of the federalist and nationalist features of ACA implementation. Contrary to the claims of ACA opponents that the law marked a federal “takeover,” the ACA's governance structures have advanced rather than suppressed state power. But we also found that the advances in state power occurred seemingly independently of the statute's structural arrangements; that is, the ACA's nationalist and federalist features both enhanced state power over health policy. These findings raise questions about whether cherished American federalism values are unique to federalist structures; they also raise the question of what exactly health care federalism is for, and why we continue to design health policy with federalism front and center. It is not clear that enhanced state power has brought better health policy. If it has not, is federalism for its own sake worth the trade-off?

Specialists and primary care physicians play an integral role in treating the twin epidemics of pain and addiction. But inadequate access to specialists causes much of the treatment burden to fall on primary physicians. This article chronicles the differences between treatment contexts for both pain and addiction — in the specialty and primary care contexts — and derives a series of reforms that would empower primary care physicians and better leverage specialists.

This fall, in California v. Texas, the Supreme Court is being asked to invalidate the entire 2,000-page Affordable Care Act again, along with the ACA's insurance-purchase mandate. This time, the law’s challengers are trying to use a false textualism to implode it. But the challengers’ textualism is not real textualism. The challengers seize on a few words in one subparagraph of the ACA’s statutory findings taken entirely out of their location and context in the law. They now argue those findings are an explicit “inseverability clause” that applies to the statute as a whole and trumps the Court’s longstanding “strong presumption” of severability — meaning that if the insurance-purchase mandate is eliminated, the whole ten-title ACA goes down with it. The challengers argue this despite the fact that those findings are specific to one subsection, of one Part, in one subtitle, of the ten-title law, and also despite the fact that the language they seize on is boilerplate language that Congress has used in scores of other statutes, not for the purpose of severability, but to justify its commerce power. They argue this even though Congress expressly tells us, in the subsection itself and also in the subsections directly above and below it, that the findings are indeed directed at establishing congressional authority under the Commerce Clause. And, they argue this even though, reading the entire subsection literally as they ostensibly would have us do, it would mean that not only the ACA goes down but also the nation’s entire pensions and employee benefits regulatory system — the 1974 ERISA statute — goes down too. And most importantly, they argue that Congress has actually spoken to the issue, even though Congress’s established drafting practices, substantiated by its drafting manuals and examples throughout the U.S. Code, make clear that when Congress actually writes an inseverability clause, it is unmistakably explicit about it and writes with specific language — Congress used none of that language in the ACA. The Court deploys a “strong presumption” of severability because striking down whole statutes is the most destructive of statutory-case remedies. Inseverability is a nuclear bomb. Congress doesn’t hide it in mouse-holes. True textualists wouldn’t go looking for it by implication. There is a burgeoning movement among legal scholars and jurists of all interpretive stripes to better understand how Congress drafts laws. Those developments, this analysis should make clear, are as relevant, if not more relevant, for textualists as for anyone else.

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

This cross-sectional study quantifies the proportion of nonexempt Medicaid beneficiaries not meeting work requirements, compares their health with nonexempt beneficiaries fulfilling requirements, and assesses their inability to work for health-related reasons.

The Affordable Care Act (ACA) offers a window into modern American federalism--and modern American nationalism--in action. The ACA's federalism is defined not by separation between state and federal, but rather by a national structure that invites state-led implementation. As it turns out, that structure was only a starting point for a remarkably dynamic and adaptive implementation process that has generated new state-federal arrangements. States move back and forth between different structural models vis-a-vis the federal government; internal state politics produce different state choices; states copy, compete, and cooperate with each other; and negotiation with federal counterparts is a near constant. These characteristics have endured through the change in presidential administration. This Article presents the results of a study that tracked the details of the ACA's federalism-related implementation from 2012 to 2017. Among the questions that motivated the project: Does the ACA actually effectuate "federalism," and what are federalism’s key attributes when entwined with national statutory implementation? A federal law on the scale of the ACA presented a rare opportunity to investigate implementation from a statute's very beginning and to provide the concrete detail often wanting in federalism scholarship. The findings deconstruct assumptions about federalism made by theorists of all stripes, from formalist to modern. Federalism’s commonly invoked attributes--including autonomy, cooperation, experimentation, and variation--have not been dependent on any particular architecture of either state-federal separation or entanglement, even though theorists typically call on "federalism" to produce them. Instead, these attributes have been generated in ACA implementation across virtually every kind of governance model--that is, regardless whether states expand Medicaid; get waivers; or operate their own insurance exchanges or let the federal government do it for them. This makes it extraordinarily challenging to measure which structural arrangements are most "federalist," especially because the various federalism attributes are not always present together. The study also uncovers major theoretical difficulties when it comes to healthcare: Without a clear conception of the U.S. healthcare system’s goals, how can we know which structural arrangements serve it best, much less whether they are working? If healthcare federalism is a mechanism to produce particular policy outcomes, we should determine whether locating a particular facet of healthcare design in the states versus the federal government positively affects, for example, healthcare cost, access, or quality. If, instead, healthcare federalism serves structural aims regardless of policy ends--for instance, reserving power to states in the interest of sovereignty or checks and balances--we should examine whether it does in fact accomplish those goals, and we should justify why those goals outweigh the moral concerns that animate health policy. The ACA did not cause this conceptual confusion, but it retained and built on a fragmented healthcare landscape that already was riddled with structural and moral compromises. This does not mean that federalism is an empty concept or that it does not exist in the ACA. Federalism scholars tend to argue for particular structural arrangements based on prior goals and values. The ACA's architecture challenges whether any of these goals and values are unique to federalism or any particular expression of it. At the same time, the ACA's implementation is clearly a story about state leverage, intrastate democracy, and state policy autonomy within, not apart from, a national statutory scheme. Its implementation illustrates how federalism is a proxy for many ideas and challenges us to ask what we are really fighting over, or seeking, when we invoke the concept in healthcare and beyond.

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.

This Article reports the results of a survey of a diverse group of forty-two federal appellate judges concerning their approaches to statutory interpretation. The study reveals important differences between their approaches and the approach that the Supreme Court purports to take. It also helps to substantiate the irrelevance of the enduring, but now-boring, textualism-versus-purposivism debate. None of the judges we interviewed was willing to associate himself or herself with “textualism” without qualification. All consult legislative history. Most eschew dictionaries. All utilize at least some canons of construction, but for reasons that range from “window dressing,” to the use of canons to assist in opinion writing, to a view that they are useful decision tools. Most of the judges we interviewed are not fans of Chevron, except for the judges on the D.C. Circuit, which hears the bulk of Chevron cases. Some of the judges interviewed believe that understanding Congress is important to a judge’s work, while others do not see how judges can use such understanding to decide cases. Most express doubt that the Supreme Court’s interpretive methodology binds the lower courts. The younger judges, who attended law school and practiced during the ascendance of textualism, are generally more formalist and accepting of the canons of construction, regardless of political affiliation. The older judges are less focused on canons, take a broader view of their delegated authority, and appear to grapple more with questions of judicial legitimacy. The approach that emerged most clearly from our interviews might be described as intentional eclecticism. Most of the judges we spoke to are willing to consider many different kinds of argument and evidence, and defend that approach as the only democratically legitimate one. Yet at the same time many observe a gap between how they actually decide cases and how they write opinions, a gap they attribute to the disconnect between the expectations of the public and the realities of judicial decisionmaking.

The devastating impact of the national opioid epidemic has given rise to hundreds of lawsuits. The plaintiffs -- who range from states, to counties, to Indian tribes, and individuals -- have cast an exceedingly broad net for defendants. They have sued not only the opioid manufacturers and the doctors who prescribed the drugs, but also the companies that distribute them, the pharmacies that sell them, and even the hospital accreditation organization that encouraged doctors to stop undertreating pain -- which they were -- two decades ago. This is not the first major national public health litigation effort -- tobacco, fast food, and guns offer earlier blueprints -- but it has some unique features. First, unlike the litigation it most resembles -- tobacco -- the opioid narrative has a far more complicated chain of causation. Opioids, unlike tobacco, have an important therapeutic purpose; they are FDA approved as safe and effective; they are often prescribed by doctors for sound medical reasons; and then they wind their way from manufacturer, to distributor, to pharmacy, to patient. This complicates litigation because defendants can argue that intervening factors (including other defendants) make any single defendant's culpability hard to isolate. Second, more than 400 of the opioid cases have now been consolidated before a single federal judge in a so-called "multidistrict litigation." That judge has chided the federal and state governments for punting the problem to the courts; he has made clear he thinks everyone is to blame; and has vowed to get a settlement, with systemic change as part of it, by the end of 2018 -- a breathtaking pace for resolution that makes his courtroom the game changer. None of this is to say that litigation is the ideal way to solve a public health problem. Concerns abound about attorneys fees', conflicts of interests, inadequate settlement and the possible overreach of the presiding judge. But litigation has already spurred change in both the industry and the practice of medicine. It has played a central role in the public response to the epidemic. This article details that story.

Background The Affordable Care Act (ACA) changed the landscape of insurance coverage, allowing young adults to remain on their parents' insurance until age 26 (Dependent Coverage Provision [DCP]) and states to optionally expand Medicaid up to 133% of the federal poverty level. Although both improved insurance coverage, little is known about the ACA's impact on observed receipt of timely access to acute care. The objective of this study was to compare changes in insurance coverage and perforation rates among hospitalized adults with acute appendicitis "after vs before" Medicaid expansion and the DCP using an Agency for Healthcare Research and Quality (AHRQ)-certified metric designed to measure pre-hospital access to care. Study Design We performed a quasi-experimental, difference-in-difference (DID) analysis of 2008-2015 state-level inpatient claims. Results Adults, aged 19 to 64, in expansion states experienced an absolute 7.7 percentage point decline in uninsured (95% CI 7.5 to 7.9) after Medicaid expansion compared with nonexpansion states. This coincided with a 5.4 percentage point drop in admissions for perforated appendicitis (95% CI 5.0 to 5.8) that was most pronounced among young adults, aged 26 to 34, just age-ineligible for the DCP (DID: 11.5 percentage points). Medicaid expansion insurance changes were 4.1 times larger than those encountered under the DCP (DID: 1.9). They affected all population subgroups and significantly reduced access-related disparities in race/ethnicity and lower-income communities. Although both Medicaid expansion and the DCP were associated with significant insurance gains, those attributable to the DCP were more concentrated among more privileged patients. Despite this trend, both policies resulted in larger reductions in perforation rates for historically uninsured and underserved groups. Conclusions Reductions in uninsured after Medicaid expansion and the DCP were associated with significant reductions in perforated appendix admission rates. Improvements in access to acute surgical care suggest that maintained/continued insurance expansion could lead to fewer delays, better patient outcomes, and reductions in disparities among the most at-risk populations.

A federal judge has rejected a challenge to the new health insurance exchanges that could have crippled the Affordable Care Act by denying tax subsidies to the 73% of Americans who are expected to purchase their health insurance through a federally run exchange.