Search

Melanie presented at twenty weeks of gestation to an obstetrics clinic in a critical access hospital in rural Vermont. She was excited to undergo routine fetal ultrasonography, but her obstetrician gave her grave news: the ultrasound revealed hypoplastic left heart syndrome, a devastating congenital heart defect. Initially, Melanie agreed in general to pursue surgical care for her fetus-a three-stage process that has somewhat uncertain results and could only be done in tertiary care facilities far from her home in Vermont. A week later, while the maternal fetal medicine and pediatric cardiology units made arrangements with colleagues in Boston, Melanie began having second thoughts. An ethics meeting was called to discuss conflicting clinician reactions to Melanie's dilemma. Most of the clinicians were stunned that the patient would change her mind. What advice should the ethics consultant offer the team about caring for Melanie?

The federal Medicaid statute provides states an incentive to tax hospitals (even otherwise tax-exempt ones) as a means of raising revenue and then leverage federal matching funds by returning at least some of the tax back to the hospitals in the form of Medicaid supplemental payments. The potential for supplemental payments is attractive to hospitals, especially those struggling to recoup the costs of treating Medicaid and uninsured patients, and has resulted in political support from hospitals for states to create hospital "taxes" in name only-hospitals and states both end up with more money than they did when they started because of the federal match. When state officials begin to perceive, however, that nonprofit hospitals may be serving private rather than public interests, they are able to use these hospital taxes as a way to incrementally chip away at the historic governmental support provided through tax exemption by redirecting the revenue raised from the hospital tax to general fund purposes rather than Medicaid supplemental payments. This article looks at how states have been using hospital taxes and supplemental payments to balance state budgets and whether this practice is consistent with the Medicaid program objectives that make the taxes politically feasible.

BackgroundSequential Organ Failure Assessment (SOFA) score predicts probability of in-hospital mortality. Many crisis standards of care use SOFA score to allocate medical resources during the COVID-19 pandemic.Research QuestionAre SOFA scores disproportionately elevated among Non-Hispanic Black and Hispanic patients hospitalized with COVID-19, compared to Non-Hispanic White patients?Study Design and MethodsRetrospective cohort study conducted in Yale New Haven Health System, including 5 hospitals with total of 2681 beds. Study population drawn from consecutive patients aged ≥18 admitted with COVID-19 from March 29thto August 1st, 2020. Patients excluded from the analysis if not their first admission with COVID-19, if they did not have SOFA score recorded within 24 hours of admission, if race and ethnicity data were not Non-Hispanic Black, Non-Hispanic White, or Hispanic, or if they had other missing data. The primary outcomes was SOFA score, with peak score within 24 hours of admission dichotomized as ResultsOf 2982 patients admitted with COVID-19, 2320 met inclusion criteria and were analyzed, of whom 1058 (45.6%) were Non-Hispanic White, 645 (27.8%) were Hispanic, and 617 (26.6%) were Non-Hispanic Black. Median age was 65.0 and 1226 (52.8%) were female. In univariate logistic screen and in full multivariate model, Non-Hispanic Black patients but not Hispanic patients had greater odds of an elevated SOFA score ≥6 when compared to Non-Hispanic White patients (OR 1.49, 95%CI 1.11-1.99).InterpretationCrisis standards of care utilizing the SOFA score to allocate medical resources would be more likely to deny these resources to Non-Hispanic Black patients.

BackgroundThe COVID-19 pandemic has had a devastating impact in the United States, particularly for Black populations, and has heavily burdened the healthcare system. Hospitals have created protocols to allocate limited resources, but there is concern that these protocols will exacerbate disparities. The sequential organ failure assessment (SOFA) score is a tool often used in triage protocols. In these protocols, patients with higher SOFA scores are denied resources based on the assumption that they have worse clinical outcomes. The purpose of this study was to assess whether using SOFA score as a triage tool among COVID-positive patients would exacerbate racial disparities in clinical outcomes.MethodsWe analyzed data from a retrospective cohort of hospitalized COVID-positive patients in the Yale-New Haven Health System. We examined associations between race/ethnicity and peak overall/24-hour SOFA score, in-hospital mortality, and ICU admission. Other predictors of interest were age, sex, primary language, and insurance status. We used one-way ANOVA and chi-square tests to assess differences in SOFA score across racial/ethnic groups and linear and logistic regression to assess differences in clinical outcomes by sociodemographic characteristics.ResultsOur final sample included 2,554 patients. Black patients had higher SOFA scores compared to patients of other races. However, Black patients did not have significantly greater in-hospital mortality or ICU admission compared to patients of other races.ConclusionWhile Black patients in this sample of hospitalized COVID-positive patients had higher SOFA scores compared to patients of other races, this did not translate to higher in-hospital mortality or ICU admission. Results demonstrate that if SOFA score had been used to allocate care, Black COVID patients would have been denied care despite having similar clinical outcomes to white patients. Therefore, using SOFA score to allocate resources has the potential to exacerbate racial inequities by disproportionately denying care to Black patients and should not be used to determine access to care. Healthcare systems must develop and use COVID-19 triage protocols that prioritize equity.

BackgroundSequential Organ Failure Assessment (SOFA) score predicts probability of in-hospital mortality. Many crisis standards of care suggest the use of SOFA scores to allocate medical resources during the COVID-19 pandemic.Research questionAre SOFA scores elevated among Non-Hispanic Black and Hispanic patients hospitalized with COVID-19, compared to Non-Hispanic White patients?Study design and methodsRetrospective cohort study conducted in Yale New Haven Health System, including 5 hospitals with total of 2681 beds. Study population drawn from consecutive patients aged ≥18 admitted with COVID-19 from March 29thto August 1st, 2020. Patients excluded from the analysis if not their first admission with COVID-19, if they did not have SOFA score recorded within 24 hours of admission, if race and ethnicity data were not Non-Hispanic Black, Non-Hispanic White, or Hispanic, or if they had other missing data. The primary outcome was SOFA score, with peak score within 24 hours of admission dichotomized as ResultsOf 2982 patients admitted with COVID-19, 2320 met inclusion criteria and were analyzed, of whom 1058 (45.6%) were Non-Hispanic White, 645 (27.8%) were Hispanic, and 617 (26.6%) were Non-Hispanic Black. Median age was 65.0 and 1226 (52.8%) were female. In univariate logistic screen and in full multivariate model, Non-Hispanic Black patients but not Hispanic patients had greater odds of an elevated SOFA score ≥6 when compared to Non-Hispanic White patients (OR 1.49, 95%CI 1.11–1.99).InterpretationGiven current unequal patterns in social determinants of health, US crisis standards of care utilizing the SOFA score to allocate medical resources would be more likely to deny these resources to Non-Hispanic Black patients.

Multidrug resistant organisms (MDROs) are a public health threat that have reduced the effectiveness of many available antibiotics. Antimicrobial stewardship programs (ASPs) have been tasked with reducing antibiotic use and therefore the emergence of MDROs. While fecal microbiota transplant (FMT) has been proposed as therapy to reduce patient colonization of MDROs, this will require additional evidence to support an expansion of the current clinical indication for FMT. This article discusses the evidence and ethics of the expanded utilization of FMT by ASPs for reasons other than severe recurrent or refractoryClostridioides(formerlyClostridium)difficileinfection.

A heated debate surrounds pharmaceutical companies’ proactive dissemination of information about uses of their drugs beyond those approved by the US Food and Drug Administration (FDA), a practice commonly referred to as “off-label promotion”. At the core of this debate is an underlying assumption that pharmaceutical company speech about off-label uses is inherently false and misleading and not in the best interests of patients. If, however, the companies’ off-label speech is truthful and not misleading, the speech may be protected by the First Amendment, making the FDA’s prohibition of off-label promotion unconstitutional. This study is the first to link alleged pharmaceutical company speech with published clinical evidence bringing data to inform the debate. To evaluate whether pharmaceutical company speech alleged in False Claim Act (FCA) complaints is supported by published clinical evidence. Reviewed were 66 FCA complaints alleging off-label promotion of branded prescription drugs. Indications in these complaints were matched to published clinical evidence using a nationally recognized compendium, Micromedex® 2.0. Of the uses alleged in FCA complaints, 51.6% (at least 22.1% of which were off-label) were supported by at least some published clinical evidence and, therefore, not inherently false or misleading. Given this evidence, the current government policy of prohibiting proactive dissemination of off-label information by manufacturers may not be consistent with the First Amendment. Some of the off-label uses alleged in FCA complaints investigated and settled by the federal government were supported by published clinical evidence; however, many of the alleged uses were unsupported by any clinical evidence and, thus, false and misleading. These results suggest that government regulation of pharmaceutical company speech remains warranted because company speech is not consistently evidence-based. Even so, evidence-based pharmaceutical company speech is protected by the First Amendment. As a result, the federal government’s historic practice of prohibiting all off-label promotion may be unconstitutional.

Lawyers are most often portrayed and understood to be zealous advocates for individual clients in adversarial litigation or zero-sum transactions. Law schools provide excellent preparation for this type of lawyer role, but lawyers' unique understanding of the law is also needed for systemic advocacy, policymaking, and legal education to solve the most difficult societal problems. An interdisciplinary public health law class is one way for law schools to provide students an opportunity to explore and develop these other professional identities.

This article reviews recently promulgated Internal Revenue Service regulations for nonprofit hospitals seeking tax exemption and a new estimate of national hospital community benefit spending, and analyzes how they point to the value of hospitals working with community partners to address the social determinants of health. It then explains how unmet legal needs function as health determinants, and suggests how hospitals' participation in medical-legal partnerships can address those needs. This article was published on December 7, 2015, at www.publichealthreports.org

Not all hospital inpatients need the level of care (including staffing, testing, monitoring, and treatment) uniquely available in the acute-care setting. In the United States, these longer-term, nonacute inpatients tend to be some combination of chronically ill, poor, homeless, undocumented, uninsured, and disabled-all groups who have struggled for health equity, political recognition, and voice. Even so, these "permanent patients" continue to receive care in one of the most expensive settings. This phenomenon is the result of federal legislation that creates an affirmative duty to care for all able to access our emergency departments without also making safe housing available to all. A handful of federal laws and policies as well as a potpourri of state laws and policies are involved.

Purpose– The purpose of the study is to review The False Claims Act (FCA) settlements and challenges facing the industry to suggest the motivation behind firms’ alleged fraudulent activity. FCA has been applied against pharmaceutical companies by the US Government to combat marketing fraud including kickbacks, improper pricing and off-label promotion. The interests of the US Government and medical professionals are also considered. Changes to the law governing pharmaceutical marketing practices are recommended.Design/methodology/approach– Cases settled under the FCA between 2005 and 2012 were identified by accessing the US Department of Health and Human Services (DHHS) Corporate Integrity Agreements Web site and annual reports and thequitamhelp.comWeb site. Case details were collected from US Department of Justice press releases, DHHS annual reports, and case documents in the Public Access to Court Electronic Records database.Findings– Of the settled cases in the final sample, improper pricing practices were evident in 33 per cent of the cases; off-label promotion in 52 per cent; and both in 15 per cent of the cases. Forty-eight per cent of the alleged fraudulent marketing activity occurred within the brands’ first year and 68 per cent within the first two years on the market. Reported settlements ranged from US$4 million to US$4.3 billion.Originality/value– This research simultaneously considers business issues facing the pharmaceutical industry and alleged fraudulent marketing activity to recommend changes to the law governing drug promotion. Changes have the potential to improve the balance between the respective interests of industry, medicine and government and to improve compliance and patient care in the future.

Most attorneys (whether in practice or academia) assume that pharmaceutical companies’ discussion and dissemination of information regarding “off-label” uses of prescription drugs (i.e., uses that have not been specifically approved by the Food and Drug Administration (FDA)) are inherently commercial in nature. Two aspects of the speech, however, suggest that it does not cleanly fall into the category of “commercial speech” for purposes of First Amendment analysis. First, most prescribers are not, in fact, purchasing drugs for their patients, and so conversations between pharmaceutical company representatives and prescribers are not directly linked to a commercial transaction the same way they are with an advertisement or sales pitch to an end consumer. Second, prescribers are “learned intermediaries,” charged by profession and law to research and weigh the range of potential risks and benefits of each product they prescribe for their patients, whether it is prescribed for an FDA-approved use or an off-label use. As a result, scientific and medical information is “inextricably linked” to any speech that would be considered merely commercial. Prior attempts to restrict speech that included both financially driven and noncommercial components have received exceptionally rigorous scrutiny when reviewed by the Supreme Court. This Article suggests that the current restrictions on some pharmaceutical company speech may be given what I shall call “enhanced intermediate” (or even strict) scrutiny, rather than the usual intermediate scrutiny given to restrictions of merely commercial speech, because of the unique professional and legal role played by prescribers.

Although a single chapter cannot address the full panoply of legal and ethical concerns associated with diagnostic genetic testing, this chapter examines three of the more pressing issues. We start by discussing informed consent of clinical patients and research subjects for genetic testing and research. We then move on to the confidentiality of genetic information and particularly concerns raised by the potential for discrimination or stigmatization of individual patients or their family members associated with disclosure of this information. We finish up with an overview of the implications for molecular pathologists posed by the patenting of genes.