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The Hatch-Waxman Act of 1984 was designed to accelerate generic drug entry by establishing a framework for resolving patent disputes between brand-name and generic manufacturers. While the Act has facilitated competition and expanded the availability of affordable medicines, brand-name firms have increasingly exploited its procedural structure to delay or deter generic competition through "serial litigation." This strategy involves filing successive, questionable lawsuits, often based on non-innovative continuation patents. Even if the brand ultimately loses, the delays and litigation costs can discourage generic firms from entering the market or compel them to settle on terms that undermine patients' timely access to affordable generics. In the case of Astellas's overactive bladder drug mirabegron (Myrbetriq), after an initial Hatch-Waxman case settled in 2020 with generic entry expected in 2024, Astellas pursued 4 additional lawsuits, each built on new but substantively indistinguishable patents. These tactics have delayed broad competition, leaving only 2 firms to launch in 2024 under the threat of massive damages. Similar patterns are observed with other drugs, including bimatoprost (Latisse), aflibercept (Eylea), and tasimelteon (Hetlioz).

Introduction: In 2017, Connecticut prohibited hospitals from billing "facility fees" for certain services delivered off their main campuses.

Methods: Using Hospital Medicare Cost Reports and the National Academy for State Health Policy Hospital Cost Data (2011-2022), we applied a difference-in-differences model within an event study framework to compare hospital financial outcomes between Connecticut hospitals and matched control hospitals nationwide.

Results: Unadjusted trends suggest small declines in operating margins and outpatient-to-total charges after the ban, alongside an increase in inpatient-to-total charges. In adjusted analyses, operating margins and inpatient-to-total charges did not change significantly, while outpatient-to-total charges declined significantly by 6.91%.

Conclusion: Given the small sample and limited precision, a policy effect cannot be ruled out for several outcomes. Future research evaluating the long-term sustainability and impacts on hospital financials, access, and care quality are warranted.

Introduction: Routine screening for health-related social needs (HRSNs) is inconsistent, creating disparities in who gets identified and supported. Transgender patients, already facing structural stigma, may be especially affected.

Methods: We analyzed electronic health records from a large urban safety-net system (2018-2023). We identified 2639 transgender patients with at least one outpatient visit and created a ∼11:1 comparison cohort of 23 944 cisgender patients. Overall, 7.5% (n = 1997) completed a Social Needs Questionnaire (SNQ), including 1840 cisgender and 157 transgender patients. We compared screening rates using chi-square tests and assessed adjusted odds for HRSN with logistic regression.

Results: Transgender patients were screened less often than cisgender patients (5.9% vs 7.7%, P = 0.001). Among those screened, they had more than twice the odds of housing instability, poor-quality housing, and healthcare costs. Odds for interpersonal violence were th3ree times higher. Findings were consistent in sensitivity analyses adjusting for age, insurance, and neighborhood.

Conclusion: Transgender patients were underscreened yet faced greater HRSNs. Standardized screening and expanded supports are critical to support transgender communities.

Background: Accurate and complete patient race and ethnicity data are essential for informing health care quality and patient safety initiatives. However, missing data remain a persistent issue. We aimed to explore the utility of preferred language to impute patient race and ethnicity.

Methods: This was a retrospective analysis from 3 emergency departments in New York City, from June 1, 2023, to May 31, 2024. We leveraged a mapping schema for imputation of missing race and ethnicity data using preferred language for categorization into the Office of Management and Budget's 7 categories. We examined concordance between preferred language and predicted categories.

Results: The proportion of patients with missing race and ethnicity data decreased from 9.7% to 8.6%, reducing missingness by 11.1%. The greatest proportion of change with the use of preferred language was for Middle Eastern and North African patients (14.7%).

Conclusion: Our findings support that language-based imputation has the potential to reduce missing race and ethnicity data and may be a helpful tool in quality improvement and research efforts. For health systems where race and ethnicity fields may not be fully detailed or have a high rate of missing data, the use of language may serve as a valuable adjunct in improving the comprehensive picture of a population.

Introduction: While Medicare Allowable Bad Debt (MBD), defined as unpaid patient financial obligations Medicare partially reimburses to hospitals, represents only 0.12% of patient revenue, policymakers and executives should note the $1.7 billion reimbursed in 2022 affects hospitals of different types in various ways (see Appendix 1). The recent passage of the One Big Beautiful Bill Act did not eliminate MBD, but elimination has been proposed, supporting a need to understand what elimination could do to hospitals.

Methods: Using Medicare Cost Reports, we conducted a retrospective, longitudinal analysis of short-term general acute-care hospitals in 2022.Total margin was evaluated with and without MBD by Critical Access Hospital (CAH), rurality, state, and Hospital Referral Region.

Results: Elimination of this reimbursement would have impacted many hospitals; though findings highlight more adverse impacts on CAHs (accounting for a 0.3% point [PP] reduction in total margin), other rural hospitals (a 0.25PP reduction), states like Nevada (a 0.48PP reduction), and certain HRRs around the Appalachia region and parts of Texas.

Conclusion: Elimination of MBD may further jeopardize financial solvency for some rural hospitals that provide access to acute care across America's vast (mostly rural) land mass, particularly in rural and underserved communities.

The credibility of global health oversight mechanisms relies on their perceived independence. What truly constitutes "independent," however, remains ill-defined. Using a mixed-methods approach that includes a literature review and 54 key informant interviews, this paper outlines 4 pillars of independence: operational, political, economic, and knowledge/technical. It then proposes a practical tool for evaluating their application-the "OPEN Framework." We tested this framework by reviewing it against 3 so-called independent monitoring bodies: the Global Polio Eradication Initiative's Independent Monitoring Board, the Global Preparedness Monitoring Board, an independent monitoring and accountability body to ensure preparedness for global health crises, and the Independent Accountability Panel for Maternal, Newborn, and Child Health. Our findings reveal that, despite intentions of independence, pragmatic constraints and dependencies often compromise autonomy. The paper argues for a shift from rhetorical to operational independence by applying this framework, identifying conflicts of interest, and actively managing them. The OPEN Framework offers a replicable methodology for evaluating, comparing, and enhancing the independence of oversight bodies, thereby fostering stronger accountability and trust in global health governance.