Health Law and Policy Commons^™

Medical Malpractice Cuts Not The Answer, Ruqaiijah A. Yearby

All Faculty Scholarship

Tort reform--legislation that aims to reduce medical malpractice suits --will not cut medical costs and improve health care unless the government addresses the proliferation of unnecessary medical errors that victimize hundreds of thousands of patients every year.

Yearby's research considers how laws enacted to grant equal access to quality health care actually can pose barriers to the disenfranchised, and she is critical of health care reform efforts that do not address the far-reaching problem of medical errors. Finding ways to curb what she calls the "alarming rate of these medical errors," not only will reduce medical malpractice suits, but save …

Vaccine Licensure In The Public Interest: Lessons From The Development Of The U.S. Army Zika Vaccine, Ana Santos Rutschman

All Faculty Scholarship

Vaccines developed by the public sector are key to preventing future outbreaks of infectious diseases. However, the licensure of these vaccines to private-sector companies under terms that do not ensure both their availability and affordability compromises their development. This Essay analyzes the recent attempted licensing deal for a Zika vaccine between the U.S. Army and Sanofi, a French pharmaceutical company. The proposed grant of an exclusive license to Sanofi triggered widespread concern because none of its substantive terms were disclosed. While § 209 of the Patent Act imposes limitations on exclusive licensure, the Army released no information supporting its finding …

Foreword, Robert Gatter

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Independence Is The New Health, Laura D. Hermer

Saint Louis University Journal of Health Law & Policy

Medicaid plays key roles in supporting our nation’s health. Under the Affordable Care Act, Medicaid took an even more central position in public health endeavors by extending coverage in all interested states to millions of adults who typically fell through the health care cracks. Nevertheless, the Trump administration is now undoing these gains by actively encouraging states to curtail access to Medicaid in key respects while using the rhetoric of health.

This article examines Trump administration efforts in two contexts: (1) state § 1115 waiver applications seeking to better align their Medicaid programs with cash welfare and food stamp programs, …

Health Justice In The Age Of Alternative Facts And Tax Cuts: Value-Based Care, Medicaid Reform, And The Social Determinants Of Health, Elizabeth Tobin-Tyler

Saint Louis University Journal of Health Law & Policy

Some provisions of the Patient Protection and Affordable Care Act of 2010 (ACA) as well as regulatory policies under the Obama administration reflected the overwhelming evidence that to reduce health care costs, and to improve quality of care and population health, the social determinants of health (SDOH) must be addressed. These policies included funding for partnerships between public health agencies, community organizations, and health care institutions, promotion of value-based payment models that incentivize integrated health and social care delivery, and support for Medicaid program innovations that directly address social needs as part of health care. The Trump administration, through a …

Political Rhetoric And Minority Health: Introducing The Rhetoric-Policy-Health Paradigm, Kimberly Cogdell Grainger

Saint Louis University Journal of Health Law & Policy

Rhetoric is a persuasive device that has been studied for centuries by philosophers, thinkers, and teachers. In the political sphere of the Trump era, the bombastic, social media driven dissemination of rhetoric creates the perfect space to increase its effect. Today, there are clear examples of how rhetoric influences policy. This Article explores the link between divisive political rhetoric and policies that negatively affect minority health in the U.S. The rhetoric-policy-health (RPH) paradigm illustrates the connection between rhetoric and health. Existing public health policy research related to Health in All Policies and the social determinants of health combined with rhetorical …

The Faltering Promise Of Fda Tobacco Regulation, Micah L. Berman

Saint Louis University Journal of Health Law & Policy

Congress passed the Tobacco Control Act (TCA) in 2009, giving the FDA the authority to regulate tobacco products for the first time. Ten years later, the promise that the TCA’s enactment would be a transformative moment for public health has not materialized. To the contrary, the FDA’s most notable regulatory effort—requiring graphic warnings on cigarette packages and advertisements—has been struck down in court, and the FDA is now scrambling to address a youth e-cigarette epidemic that caught it off guard. This Article provides a brief review of TCA implementation during the Obama administration, and it reviews the Trump administration’s “comprehensive …

What Hope For Health In All Policies’ Addition And Multiplication Of Equity In An Age Of Subtraction And Division At The Federal Level?: The Memphis Experience, Amy T. Campbell

Saint Louis University Journal of Health Law & Policy

Increasingly, people recognize that social factors, such as poverty, the living environment, and educational status, substantially affect health outcomes. A “health in all policies approach” (HiAP) seeks structural reform of policymaking to require purposeful consideration, across an interconnected range of public sector actors, of the health equity and justice policy-level considerations of these factors. With the election of Donald J. Trump as 45th President in the United States, however, the U.S. entered a world where the math of the day is division and subtraction, rather than addition or multiplication. And yet, hope in HiAP remains through examples of innovative approaches …

“I Walk In, Sign. I Don’T Have To Go Through Congress.” President Trump’S Use Of Executive Orders To Unravel The Patient Protection And Affordable Care Act, Elizabeth Van Nostrand, Tina Batra Hershey

Saint Louis University Journal of Health Law & Policy

Executive orders, used by presidents to advance their administrations’ agendas, have changed history. These powerful written instruments were used to confine Japanese Americans during World War II, desegregate public schools, and create NASA. On the day of his inauguration, President Donald J. Trump issued his first Executive Order which directed secretaries of executive branch agencies to begin dismantling President Barack Obama’s flagship initiative—the Patient Protection and Affordable Care Act (ACA). This action, along with subsequent executive orders, precipitated a flurry of regulatory change and judicial challenges. Whether President Trump will ultimately be successful in crippling the ACA is still to …

Three Lost Ebola Facts And Public Health Legal Preparedness, Robert Gatter

Saint Louis University Journal of Health Law & Policy

Three key facts about Ebola Transmission should drive policy designed to control the risk of transmission during a crisis.

• Ebola—like HIV—is not easily transmissible human-to-human.
• Ebola has “dry” and “wet” symptoms, and only the wet symptoms threaten public health.
• A fever is Ebola’s canary in a coal mine; it provides timely warning of a coming threat.

Yet, during the U.S. Ebola scare in 2014, these three facts were lost. Unnecessary quarantine, stigma, and burden on those exposed to Ebola resulted, including especially for those who volunteered to fight the disease at its source abroad. Tragically, the law permitted these injustices …

Law Enforcement And Executive Order: Duplication In Missouri’S Prescription Drug Monitoring Program, Colleen A. Kinsey

Saint Louis University Journal of Health Law & Policy

Missouri had long been scrutinized as the only state operating without a prescription drug monitoring program. These programs are seen as an effective way to monitor prescription opioids as opioid-related deaths have risen in the past decade. The opioid crisis has gained significant media attention and cast scrutiny on pharmaceutical companies, physicians, and state and federal governments. This comment explores the history of the opioid crisis and details Missouri’s struggle to implement a prescription drug monitoring program legislatively. In 2017, former Governor Eric Greitens signed an Executive Order directing the Missouri Department of Health and Senior Services to implement one …

Stretching Armstrong: How The Eighth Circuit Incorrectly Applied Supreme Court Precedent In Does V. Gillespie, Lauren E. Pair

Saint Louis University Journal of Health Law & Policy

Medicaid serves as an important source of health insurance for millions of Americans. One of the Act’s core tenants is the patient’s freedom to choose from any qualified and willing provider. This “freedom of choice” provision was eventually codified, and subsequent protections were put in place to protect a patient’s choice regarding family planning services. However, as states attempt to limit access to family planning services by severing their Medicaid contracts with Planned Parenthood, patients must rely on § 1983 to pursue relief in federal courts. Section 1983 provides a right of action for the violation of any federal right …

Masthead

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Macra And Medicare’S Elusive Quest For Fairness And Value With Physician Payment Policy: Speeding Up The Transition To “Big Med”, Rick Mayes, Soleil Shah

Saint Louis University Journal of Health Law & Policy

This article traces the evolution of Medicare physician payment policy from the program’s beginning to the passage of the 2015 Medicare Access and CHIP Reauthorization Act (MACRA). Based on interviews, primary data sources, and an extensive review of the secondary literature, the authors provide an analysis of: (1) some of the most significant events, trends and factors that led to the Act’s passage, (2) MACRA’s basic design and the primary options it gives to physicians, and (3) the major concerns many physician representatives and health policy experts have about MACRA. As the majority of physicians will likely feel the need …

Table Of Contents

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Putting The Brakes On Consumer Driven Medicaid: The Failures And Harms Of Healthy Indiana Plan (Hip) 2.0, Sidney D. Watson

Saint Louis University Journal of Health Law & Policy

In January 2015, the U.S. Department of Health and Human Services (HHS) granted Indiana a Section 1115 Demonstration Waiver to experiment with consumer driven Medicaid. The Healthy Indiana Plan (HIP) 2.0 combines a $2,500 high deductible with a Personal Responsibility and Wellness (POWER) Account, premiums, and copays. Described as “the most significant departure from traditional Medicaid ever approved,” Indiana claims that the POWER Account, the signature feature of HIP 2.0, is “similar to a health savings account (HSA)” and encourages members to be more cost-conscious consumers, helps familiarize members with how commercial health insurance works, and encourages continuous Medicaid enrollment. …

The Body Politic: Federalism As Feminism In Health Reform, Elizabeth Y. Mccuskey

Saint Louis University Journal of Health Law & Policy

This essay illuminates how modern health law has been mainstreaming feminism under the auspices of health equity and social determinants research. Feminism shares with public health and health policy both the empirical impulse to identify inequality and the normative value of pursing equity in treatment. Using the Affordable Care Act’s federal health insurance reforms as a case study of health equity in action, the essay exposes the feminist undercurrents of health insurance reform and the impulse toward mutuality in a body politic. The essay concludes by revisiting—from a feminist perspective—scholars’ arguments that equity in health insurance is essential for human …

Regulatory Implications Of The Comprehensive Care For Joint Replacement Demonstration Project, Thomas W. Brewer

Saint Louis University Journal of Health Law & Policy

An often overlooked provision in the Patient Protection and Affordable Care Act is the authorization of demonstration projects which incentivize providers to develop, implement, and test novel, cost-cutting approaches to care delivery. One such project, the Comprehensive Care for Joint Replacement demonstration project, encourages providers across the continuum of care to collaborate on strategies that improve the quality of and lower the cost of complete joint replacements. The project allows providers to share the benefits of cost savings, and liabilities for cost overruns, across the surgeons performing procedures, acute care facilities, and post-acute care facilities. Arrangements of this type, outside …

Finding An Unlikely Combatant In The War Against Ransomware: Opportunities For Providers To Utilize Off-Site Data Backup Within The Hipaa Omnibus And Hitech Amendments, Jordan Butler

Saint Louis University Journal of Health Law & Policy

Each day the health care sector is subjected to an onslaught of thousands of ransomware virus attacks which attempt to capture a provider’s IT operations until a ransom is paid to the hacker. Apart from monetary, functional, and civil liability considerations, compromised health systems that contain electronic patient health information could expose a provider to legal liability under multiple HIPAA laws. This article will explore how recent amendments made to HIPAA, particularly under the Omnibus and HITECH Acts, incentivize providers to obtain legal, functional, and policy-based benefits by utilizing off-site data backup business associates as part of their cybersecurity defense …

Table Of Contents

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Masthead

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Overlapping And Concurrent Surgeries: An Analysis Of Informed Consent When There Is Incomplete Risk Information, Caitlan E. Grombka-Murphy

Saint Louis University Journal of Health Law & Policy

The practice of overlapping and concurrent surgeries—where a single surgeon runs two or more operations at once—is not new. However, it was not until 2015, through the Boston Globe’s investigation, that the general public learned the details of such practices. Lack of transparency surrounding these practices regrettably has created a culture of distrust within the surgeon-patient relationship. The core concern of overlapping and concurrent surgeries is the potential for patient risk. Scientific research on how much additional risk overlapping or concurrent surgeries place on the patient is still in its early stages. This article explores current scientific research, noting …

Segregation In St. Louis: Dismantling The Divide, For The Sake Of All [In Collaboration With], Thomas Harvey, John Mcannar, Michael-John Voss, Ascend Stl Inc., Community Builders Network Of Metro St. Louis, Metropolitan St. Louis Equal Housing And Opportunity Council (Ehoc), Team Tif

All Faculty Scholarship

Place matters. Where people live in St. Louis has been shaped by an extensive history of segregation that was driven by policies at multiple levels of government and practices across multiple sectors of society. The effect of segregation has been to systematically exclude African American families from areas opportunity that support economic, educational, and health outcomes.

Ip Preparedness For Outbreak Diseases, Ana Santos Rutschman

All Faculty Scholarship

Outbreaks of infectious diseases will worsen, as illustrated by the recent back-to-back Ebola and Zika epidemics. The development of innovative drugs, especially in the form of vaccines, is key to minimizing future outbreaks, yet current intellectual property (IP) regimes are ineffective in supporting this goal.

IP scholarship has not adequately addressed the role of IP in the development of vaccines for outbreak diseases. This Article fills that void. Through case studies on the recent Ebola and Zika outbreaks, it provides the first descriptive analysis of the role of IP from the pre- to the post-outbreak stages, specifically identifying IP inefficiencies. …

Healthcare Blockchain Infrastructure: A Comparative Approach, Ana Santos Rutschman

All Faculty Scholarship

Blockchain has been hailed as the most disruptive technology of the next decade. One of the areas of immediate application is healthcare, where different types of blockchain applications could help streamline data sharing, protect patient privacy, and assist in the monitoring of drug shipments. This Article explores the first steps taken by healthcare companies in the United States to incorporate blockchain solutions into their business models. It then contrasts them to ongoing experiments in the European Union, with a focus on Sweden’s adoption of CareChain (a national, interoperable blockchain health data platform) and Estonia’s digitization of 95% of the country’s …

Accessibility Of Medical Diagnostic Equipment - Implications For People With Disability, Lisa Iezzoni, Elizabeth Pendo

All Faculty Scholarship

Under Attorney General Jeff Sessions, the U.S. Department of Justice (DOJ) has inactivated or rescinded numerous rules and guidelines issued by prior administrations, sometimes attracting considerable public attention in the process. Little noticed, however, was a decision by the DOJ on December 26, 2017, to formally withdraw four Advance Notices of Proposed Rulemaking related to Titles II and III of the Americans with Disabilities Act (ADA), including rulemaking that addressed making medical diagnostic equipment accessible to people with disability. For now, this step halts efforts on a national level to ensure accessibility of such equipment, which includes exam tables, weight …