Firearm Policy in the Hospital Setting-Recognizing Health Care as a "Sensitive Place".

Importance: Hospitals are hot zones of the US gun injury epidemic. To shelter these facilities from the dangers of gun violence, state legislatures have enacted laws to reduce the carrying of firearms on hospital premises. However, these efforts currently face serious Second Amendment challenges in federal courts. The ongoing legal battles, which have wide-ranging implications for patient and clinician safety as well as public health generally, are setting the stage for a Supreme Court case that may decide the fate of firearm regulations in US hospitals. A permissible pathway for advancing sensible gun regulation in hospitals is urgently needed. Observations: Since the Supreme Court established a new constitutional test for firearm laws in New York State Rifle & Pistol Association v Bruen (2022), states now face unprecedentedly high barriers to enacting health-protecting legislation regarding firearms. Post-Bruen, the Supreme Court requires that laws be consistent with "this Nation's historical tradition of firearms regulation." This means that states hoping to enact laws barring public carry of firearms in hospitals must demonstrate that hospitals are a "sensitive place" as a historical matter (ie, analogous to a location where firearms were traditionally restricted). By reasoning from analogy, it is clear several historical comparators exist for regulating firearms in hospitals. Although the hospital (as understood today) did not exist in the 1700s, it is sufficiently analogous to asylums and schools, to name a few examples. These settings all share a common denominator with the modern-day hospital: serving vulnerable populations or individuals who may be at heightened risk of misusing firearms. Conclusions and Relevance: The Supreme Court's interpretation of the Second Amendment right to bear arms is threatening democratically enacted laws seeking to shelter hospitals from firearm violence. However, it is clear that hospitals and other health care settings are a sensitive place with compelling historical analogies. Policymakers' strategic deployment of the sensitive places designation, along with its rightful judicial recognition in the hospital setting, are critical to upholding laws that protect health care facilities, patients, and professionals from firearm violence-a conclusion consistent with the US Constitution, history, medical ethics, and common sense.

Real-World Evidence in the Real World: Beyond the FDA.

The 21st Century Cures Act ("Cures Act") 1 relies on the concept of real-world evidence ("RWE") 2 to improve the Food and Drug Administration ("FDA") approval process. This has amplified interest and furthered momentum in applying RWE more broadly, beyond FDA regulation. In this article, we discuss the understandable appeal of RWE's pragmatic application and its many potential benefits. But we also caution that claims about RWE's wide-ranging, ameliorative impact on the health care system are likely overstated. The real world of RWE is messy and uncertain. Successfully incorporating RWE into regular health care system decision-making, beyond the FDA, faces considerable obstacles and limitations. We review the reasons to be wary about RWE as a game-changer. These concerns including data reliability, insufficient incentives for stakeholders to generate and engage with high-quality RWE, and lack of comprehensive regulatory oversight. In addition, the push for RWE may impact the enforcement of the health care fraud and abuse laws, perhaps not in necessarily positive ways. Increased reliance on RWE may have significant implications for off-label fraud enforcement, further conflating the distinction between claims that are false for reimbursement rather than for scientific purposes.

Deciphering the Sunshine Act: Transparency Regulation and Financial Conflicts in Health Care.

The Physician Payments Sunshine Act ("Sunshine Act"), enacted to address financial conflicts in health care, is the first comprehensive federal legislation mandating public reporting of payments between drug companies, device manufacturers, and medicine. This article analyzes the Sunshine Act's uneven record, exploring how the law serves as an intriguing example of the uncertain case for transparency regulation in health care. The Sunshine Act's bumpy rollout demonstrates that commanding transparency through legislation can be arduous because of considerable implementation challenges. Capturing all the relevant information about financial relationships and reporting it with sufficient contextual and comparative data has proven disappointingly difficult. In addition, the law suffers from uncertainty and poor design as to the intended audience. Indeed, there is strong reason to believe that it will not significantly impact decision-making of primary recipients like patients. Yet the Sunshine Act nonetheless retains important and perhaps underappreciated value. From the almost four years of information generated, we have learned that industry-medicine financial ties vary significantly by physician specialty, and somewhat by physician gender. In many medical fields the distribution of top dollar payments tends to be heavily skewed to a few recipients, all of which have important implications for optimal management of financial conflicts and for health policy more generally. Accordingly, the Sunshine Act's greatest potential is not guiding decisions of individual patients or physicians, but its downstream effects. This Article traces how secondary audiences, such as regulators, watchdogs, and counsel are already starting to make productive use of Sunshine Act information. Public reporting has, for example, made more feasible linking industry payment information with Medicare reimbursement data. As a result, policymakers can more closely examine correlations between industry spending directed at individual physicians and their prescribing and referral decisions. Moreover, savvy counsel are recognizing that Sunshine Act information provides explosive evidence in private civil litigation and this Article explores the first wave of cases.

Shadows amid sunshine: regulating financial conflicts in medical research.

Under brand new rules implementing the Physician Payments Sunshine Act (Sunshine Act), a wide range of financial relationships, including many research-related payments, between industry, physicians, and teaching hospitals will be publicly disclosed through comprehensive, standardized payment reporting. The Sunshine Act represents the latest in a series of regulatory attempts to address financial conflicts of interest that may bias research conduct and threaten subject safety. This article summarizes the major aspects of the Sunshine Act affecting medical research, how it interacts with existing laws and policies, and identifies important unresolved issues and implementation challenges that still lie ahead with the rollout of the legislation underway. The Sunshine Act primarily depends on disclosure as a regulatory tool. As such, its long-term impact remains open to question. Disclosure in this context may have limited utility given, among other reasons, uncertainty about who the intended recipients are and their ability to use the information effectively. Apart from the insufficiency of transparency, this article further explores how proportionality, fairness, and accountability considerations make optimal regulation of financial conflicts in medical research quite challenging.

Is it really all about the money? Reconsidering non-financial interests in medical research.

Concern about financial conflicts crowds out sufficient consideration of other interests that may bias research conduct. Regulations, institutional policies, and guidance from professional bodies and medical journals all primarily focus on financial ties. But why? Economic gain is not the only powerful influence. This article argues that we under-prioritize non-financial interests in the regulation of medical research. It critiques the usual reasons given for regulating financial and non-financial interests differently - that the interests contrast in terms of tangibility, that financial interests are optional, and that financial interests can be efficiently carved out as a discrete area of focus. Moreover, disparate regulatory treatment seems inattentive to the very similar social and psychological forces that animate the bias effect of both financial and non-financial interests and fails to account for how financial and non-financial interests synergistically interact. Under-prioritization of non-financial interests threatens to erode public trust and creates negative spillover effects that weaken financial conflicts regulation. Optimal regulation requires a more integrated, balanced, and proportionate response to secondary interests in medical research.

The new era of comparative effectiveness: will public health end up left behind?

The Patient Protection and Affordable Care Act created the nation's first comprehensive comparative effectiveness research (CER) program. According to some optimistic accounts, CER will revolutionize clinical practice and transform the health care delivery system. But what about public health? There are reasons for concern that it could end up left behind in the new era of comparative effectiveness. This article analyzes the considerable promise and serious limitations of applying CER to public health. It also highlights important issues that will likely emerge for public health law and policy as the health care system transitions to greater reliance on CER.

In tepid defense of population health: physicians and antibiotic resistance.

Antibiotic resistance menaces the population as a dire public health threat and costly social problem. Recent proposals to combat antibiotic resistance focus to a large degree on supply side approaches. Suggestions include tinkering with patent rights so that pharmaceutical companies have greater incentives to discover novel antibiotics as well as to resist overselling their newer drugs already on market. This Article argues that a primarily supply side emphasis unfortunately detracts attention from physicians' important demand side influences. Physicians have a vital and unavoidably necessary role to play in ensuring socially optimal access to antibiotics. Dismayingly, physicians' management of the antibiotic supply has been poor and their defense of population health tepid at best. Acting as a prudent steward of the antibiotic supply often seems to be at odds with a physician's commonly understood fiduciary duties, ethical obligations, and professional norms, all of which traditionally emphasize the individual health paradigm as opposed to population health responsibilities. Meanwhile, physicians face limited incentives for antibiotic conservation from other sources, such as malpractice liability, regulatory standards, and reimbursement systems. While multifaceted efforts are needed to combat antibiotic resistance effectively, physician gatekeeping behavior should become a priority area of focus. This Article considers how health law and policy tools could favorably change the incentives physicians face for antibiotic conservation. A clear lesson from the managed care reform battles of the recent past is that interventions, to have the best chance of success, need to respect physician interest in clinical autonomy and individualized medicine even if, somewhat paradoxically, vigorously promoting population health perspectives. Also, physicians' legal and ethical obligations need to be reconceptualized in the antibiotic context in order to better support gatekeeping in defense of population health. The principal recommendation is for increased use of financial incentives to reward physicians for compliance with recommended guidelines on antibiotic prescribing. Although not a panacea, greater experimentation with financial incentives can provide a much needed jump-start to physician interest in antibiotic conservation and likely best address physicians' legitimate clinical autonomy concerns.