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Disparities in Health Care: The Pandemic’s Lessons for Health Lawyers
No full textPopulation-level disparities in health and health care came to the forefront of U.S. public consciousness in 2020. As the racial, ethnic, and socioeconomic stratification of COVID-19 infection and death rates emerged with chilling clarity, the Black Lives Matter protests of the summer focused millions of Americans on the complex, structural nature of inequity and its long-lasting effects./= / \u3e/= / \u3eAccess to quality health care is a “social determinant of health,” meaning that it is one of the “non-medical factors that influence health outcomes . . . the conditions in which people are born, grow, work, live, and age, and the wider set of forces and systems shaping the conditions of daily life.” Although it may seem obvious that differential access to high-quality care results in differential health outcomes, less obvious are the ways that multiple factors—including facially neutral laws and organizational practices—interact over time to produce population-level disparities in care and outcomes./= / \u3e/= / \u3eIn 2021, all U.S. health lawyers should monitor and consider the following key developments affecting equitable access to health care:/= / \u3e/= / \u3e• The ongoing pandemic response and the disparate access to U.S. health care systems that it reveals;/= / \u3e/= / \u3e• The ongoing expansion of Medicaid eligibility under the Patient Protection & Affordable Care Act (ACA) and the legality of exceptions to federal requirements granted to state Medicaid programs;/= / \u3e/= / \u3e• The continuing evolution in publicly-funded health insurance toward payment models that reward positive health outcomes (and punish poor ones); and/= / \u3e/= / \u3e• The ongoing debate over federal law preventing discrimination in health care eligibility and delivery of care./= / \u3e/= / \u3eDifferences in health outcomes between populations—defined not only by differences in race, ethnicity, and socioeconomic status, but also by disability status, age, geographic location, language, immigration status, gender, gender identity, and sexual orientation—are not new. Nor are group differences in access to care, insurance coverage, and quality of care that closely align to social, economic, and/or other environmental disadvantage. But, with intensifying and warranted attention to health inequity and its financial and social costs, U.S. health lawyers across the system should be alert to the ways that facially neutral organizational practices and policies reinforce health care disparities and thereby contribute to disparate health outcomes
Ignoring Information Quality
Get PDFEntry into the patent system is guarded by an examination process to screen out applications that impose undue costs on the public without commensurate benefit. To do this, patent examiners rely heavily on various pieces of information-both provided by the patent applicant and independently discovered by the examiner-to assess whether an application should be granted. This Article shows that there are few mechanisms at the U.S. Patent and Trademark Office for questioning the veracity of this information, even though it may be incorrect. Rather, patent examination often assumes that existence of information equals accuracy of information. Consequently, examiners may rely on information that is wrong and many decisions about patent grant may also be wrong.
While it is well known that patent examiners make frequent errors, the existing scholarship is almost entirely about what this Article terms matching errors (where examiners do not find information that actually exists), when digging errors (where examiners find information but the information is wrong) may in fact be more common. Digging errors have serious harms: nuisance suits, decreased incentives for research, and slowed technological development. The matching-digging framework introduced by this Article not only reveals new errors, it also makes the case that existing policy tools to address examination errors will not prevent or resolve these errors. Existing policy tools require that errors be visible to the public, which is currently true for matching errors but is not for digging errors. Solutions to digging errors should therefore be information forcing to remedy this asymmetry; and this Article includes several recommendations. Further, this Article uses the matching-digging framework to reconceptualize examination as a system of quasi-registration that defers many decisions about patentability to litigation. Patents should thus not be given a presumption of validity and doctrines of patentability as applied in litigation should not mimic their prosecution counterparts
American Edibles: How Cannabis Regulatory Policy Rehashes Prohibitionist Fears and What to do About It
Get PDFWhy can’t we buy a cannabis muffin with our morning coffee? For much of the past century, the answer was simple: cannabis was illegal. Now, however, with more and more states legalizing cannabis for adult use, the answer is far less clear. Even in those states that have legalized cannabis, the simple action of buying and eating edibles at the same location has somehow remained a pipe dream despite consumer demand. Digging a little deeper, we can see how contemporary alarmism, by rehashing the same prohibitionist rhetoric demonizing cannabis for over eighty years, has once again arisen with a new target: cannabis-infused edibles. From journalists to policymakers to legal scholars, the rekindling of prohibitionist arguments against edibles has had real world impacts on the regulation of cannabis edibles, to the harm of all involved./= / \u3e/= / \u3eThis Article explores contemporary cannabis edibles regulation using historical, scientific, and legal frameworks to explain why current edibles regulation is so problematic, and what to do about it. By delving into the history of cannabis prohibition, this Article shows how the very same arguments propping up prohibitionist edibles policies are rooted in bad-faith arguments made decades ago that themselves were merely thin veils for racism. Applying this historical perspective and a rational understanding of contemporary cannabis edibles, this Article explores how states have used prohibition-inspired regulations to address two main concerns—overconsumption and inadvertent consumption— and how such regulations need to be revisited and revised. This Article then argues that social consumption sits at the crux of edibles regulation, and that states must implement social consumption imminently to address the harms that current regulations do not address, or even worse, perpetuate
Keep Passing the Baton: Reflections on the Legacy of Ruth Bader Ginsburg
Get PDFFor those who care about justice, particularly for marginalized communities, September 18, 2020 brought immense heartbreak.2 On that day, which happened to be Rosh Hashanah, Justice Ginsburg, who had previously written about how her religious background shaped her career as a lawyer, 3 passed away.
When Justice Ginsburg passed, many highlighted that a person who dies on Rosh Hashanah, the start of the Jewish New Year, is a Tzadik, which is a title given to people of great righteousness. 4 For example, Nina Totenberg, a reporter for National Public Radio, explained, A Jewish teaching says those who died just before the Jewish New Year are the ones God has held back until the last moment, because they were needed most, and were most righteous. 5 No truer words have been spoken about Justice Ginsburg. Throughout her career as a professor, practicing lawyer, and jurist, Justice Ginsburg revealed to the world exactly why she was among those persons who were most needed and most righteous in our society. She was a guiding light on the United States Supreme Court, a warrior for justice, and an inspiration to millions of people. Through her example, she reminded all of us who care about justice and equality how we have to be vigilant in the fight for these principles and goals every day
The Impact of Infections on Reimbursement in 92 US Hospitals, 2015-2018
No full textBackground The diagnosis-related group (DRG) is a payment system introduced to standardize healthcare costs. However, reimbursement reimbursement for treatment of infections does not always cover costs. Methods We used 2015-2018 data from 92 US hospitals in the Becton Dickinson Insights Research Database to compare the financial burden of hospital admissions within non-infection DRGs for patients with a bacterial infection (INF+) versus those without an infection (INF-). Included patients were adults with a hospital length of stay (LOS) ≥3 days and evidence of infection. Multi-variable adjusted analyses via generalized linear mixed models were used to evaluate the impact of an infection on outcomes. Results We analyzed data from 133,423 INF+ admissions and 170,531 INF- admissions. Infections were associated with an approximately two-fold increase in model-estimated LOS (9.2 vs 4.8 d; P \u3c .001) and intensive care unit LOS (5.1 vs 2.8 d; P \u3c .001). The average additional hospital cost for INF+ versus INF- admissions was 1,067 (P = .006). Only private insurance payers had a positive margin. Conclusions Current reimbursement options for infections result in significant hospital financial burden. Reimbursement models should be reconsidered to enable adoption of costlier diagnostics and antimicrobials
(Hypothetical) Communication in (Hypothetical) Context
Get PDFThis article is from the Multimember Legislative Bodies and Intended Meaning portion of a Symposium on Two Problems of Group Authorship. This essay is a response to the the two questions addressed at the symposium. These questions have been attached as an additional file to this submission. It is recommended that those questions be read before reading Lawson\u27s response
What is Privacy? That’s the Wrong Question
Get PDFPrivacy has never had a precise meaning. But in the early 1900s, the concept took on new life as a term of art in legal frameworks. The result has been a bit of a mess, as no singular definition has been adequate for all purposes. Daniel Solove, perhaps the most influential privacy scholar of our day, wrote at the turn of the millennium that privacy was “a concept in disarray.”In this short essay reflecting upon Solove’s impact on the modern study of information privacy, I argue that the chaos and futility of competing conceptualizations of privacy is why Solove’s research on privacy has been so important. Solove has reshaped the entire narrative around privacy by suggesting that we stop obsessing over what privacy is and start asking what privacy is for. His contributions have profoundly influenced the privacy debate by dispelling the notion that privacy is only important to people with “something to hide.” He cast doubt upon people\u27s ability to engage in “privacy self-management.” He introduced new narratives for industry’s data processing efforts that are closer to a Kafkaesque byzantine bureaucratic nightmare than Orwellian dystopian surveillance. He helped usher in the algorithmic turn in privacy scholarship and enriched our understanding of the full spectrum of privacy harms. Perhaps most importantly, Solove’s work provides a structure that frees scholars and lawmakers of the burden of finding one, singular notion of privacy to rule them all.Privacy is still a concept in disarray. But that’s okay. There is now too much data that is collected by too many different entities and used in too many different ways for any singular definition of privacy to be legally useful anyway. Daniel Solove’s work on understanding privacy has imposed order upon chaos, shifting our focus away from questions about what privacy is and toward the different problems we want our privacy rules to address and the specific values we want them to serve
The Criminalization of Foreign Relations
Get PDFOvercriminalization has rightly generated national condemnation among policymakers, scholars, and practitioners alike. And yet, such scholarship often assumes that the encroachment of criminal justice stops at our borders. This Article argues that our foreign relations are also at risk of overcriminalization due to overzealous prosecution, overreaching legislation, and presidential politicization—and that this may be particularly problematic when U.S. criminal justice supplants certain nonpenal U.S. foreign policies abroad. This Article proposes three key reforms— presidential distancing, prosecutorial integration, and legislative de-escalation—to assure a principled place for criminal justice in foreign relations
Clinical Research Compliance Manual: An Administrative Guide, Fourth Edition
No full textClinical Research Compliance Manual: An Administrative Guide, Fourth Edition
For anyone receiving or applying for clinical research funding, Clinical Research Compliance Manual: An Administrative Guide covers today\u27s most crucial topics, including: Human subject protections Institutional Review Board regulations and requirements Conflicts of interest Scientific misconduct Reimbursement issues And much more!
Clinical Research Compliance Manual helps you establish best practices and carry out all administrative tasks in a compliant manner while keeping you completely up-to-date on the most recent developments: Covers the major clinical research issues - with chapters written by experts in the field Provides legal explanations of the major regulatory issues in an easy-to-understand format Includes summaries of federal regulatory agencies, analysis of major cases, flowcharts, checklists, and footnotes to compliance program development, auditing and monitoring
Clinical Research Compliance Manual has been updated to include: Discussion on the revised Common Rule Analysis of enforcement of the May 25, 2018 GDPR New information on HHS’s updated informed consent in human subject research regulations commonly referred to as the “2018 Rules” Updated sections on NIH Supported Clinical Research, including a discussion of recent changes made to the Bayh-Dole Act of 1980 Revised sections on the categorization of medical devices as it pertains to reimbursement
And much more
United States
No full textThe US healthcare industry remains at a crossroads. The healthcare reform legislation passed under President Barack Obama in 2010, officially called the Patient Protection and Affordable Care Act (ACA) but widely referred to in the United States as ‘Obamacare’, resulted in significant changes in the US healthcare system. These changes included a dramatic expansion in the number of insured patients, contributing to increased demand for services. Many of these newly insured are covered by the joint state-federal Medicaid programme, which generally covers low-income patients as an entitlement programme, and reimburses at the lowest rates in most markets. However, the ACA has created a number of challenges for the US healthcare system as well, owing to both increased demand driven by newly insured patients and a view by many providers that the rates paid by many payers for healthcare services are inadequat