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Saint Louis University Journal of Health Law & Policy

No abstract provided.

Foreword: Competition’S Achilles Heel, Thomas L. Greaney

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Optimizing Private Antitrust Enforcement In Health Care, Anne Marie Helm

Saint Louis University Journal of Health Law & Policy

Americans are paying too much for health care services and insurance, in large part due to insufficiently competitive markets. Waves of consolidation have fortified providers and insurers with market power, resulting in higher prices and lower quality for consumers. As antidotes, advocates have proposed various legislative, regulatory, and enforcement solutions. Yet, unlike public antitrust enforcement, private antitrust enforcement is either not mentioned or criticized as sour grapes from competitors or a money grab by consumers. Instead of ignoring or bashing private litigation, those looking to address the health care pricing crisis in the United States should be looking to optimize …

The Anti-Competitive Potential Of Cross-Market Mergers In Health Care, Jaime S. King, Erin C. Fuse Brown

Saint Louis University Journal of Health Law & Policy

Health care consolidation in the United States has been widespread at all levels and across all entities. This consolidation has extended beyond horizontal mergers of hospitals or other providers to include out-of-market mergers, or cross-market mergers. Cross-market mergers include the merger or acquisition of any health care entity that does not directly compete with the acquiring entity in the same product or geographic market. Antitrust enforcers have historically had little in the way of market theory, economic models, or empirical data to inform their analyses on the potential impacts of cross-market mergers on competition. However, recent developments in economic theory …

Competition As Policy Reform: The Use Of Vigorous Antitrust Enforcement, Market-Governance Rules, And Incentives In Health Care, Emilio Varanini

Saint Louis University Journal of Health Law & Policy

In health care, the increase in market concentration on both the insurer side and the provider side has led to insurers and providers acquiring market power. Insurers and providers, in turn, have used that market power to charge higher prices to employers providing employees with medical care without corresponding increases in the quality of that care. Responding more generally to the increase in market concentration in many industries in the United States with a range of inimical effects for the nation’s economy, the Obama Administration suggested a range of policy solutions that this article groups under the term “Competition as …

Managing Medicaid, Isaac D. Buck

Saint Louis University Journal of Health Law & Policy

In a steady but rapid march, managed care has come to Medicaid. Privatization has undoubtedly rebuilt the Medicaid landscape across America over the last three decades. Now, as managed care programs administer health care to three-in-four Medicaid beneficiaries nationwide, whether or not managed care is adequately managing America’s largest public insurance program has become an increasingly important question.

Of particular note have been states’ difficulties in constructing and organizing the bidding and selection processes of the private companies tasked with overseeing the administration of private Medicaid plans. Legal challenges to various states’ bid procurement processes have been well documented. These …

When Is Competition Not Competition: The Curious Case Of Medicare Advantage, Robert A. Berenson

Saint Louis University Journal of Health Law & Policy

Policymakers routinely assume that Medicare Advantage plans and the traditional Medicare program compete for beneficiaries. Yet the District of Columbia federal district court blocked the proposed Aetna and Humana merger, finding that for purposes of antitrust analysis Medicare Advantage plans and traditional Medicare are effectively in different product markets. That is, they do not compete. This article reviews the basis for the court decision, which relied to a large extent on information that Medicare beneficiaries select their insurance coverage based on durable preferences either for the Medicare Advantage or the traditional Medicare option.

The article explores whether the apparently durable …

Taking Quality Of Health Care Seriously In Provider Merger Analysis, Kent Bernard

Saint Louis University Journal of Health Law & Policy

Traditionally, antitrust analysis had no method to quantify the benefits of better health care outcomes from a potential merger to balance them against the potential for increased costs. However, a branch of health care economics allows for that calculation. This approach has not been used in antitrust analysis to date, but United States law is flexible enough to allow such an approach, and the 2010 Horizontal Merger Guidelines contemplate it in Section 5. It enables us to use established procedures to put quality of care into health care merger analysis.

Avoiding Sticker Shock: Legislative Approaches To Protect Consumers From Surprise Medical Bills, Merlow M. Dunham

Saint Louis University Journal of Health Law & Policy

Consumers are increasingly receiving surprise medical bills, where an insured patient is unexpectedly billed directly for medical services received at an in-network health care facility from an out-of-network provider. These situations often arise in emergency rooms, operating rooms, and delivery rooms, despite the efforts of patients to receive care only from in-network providers. Surprise medical bills commonly leave consumers on the hook for thousands of dollars for out-of-network services that they had no opportunity to refuse. This article explores how the steady rise of narrow provider network health plans and the often-corresponding lack of transparency regarding which providers are included …

Working Well(Ness): The Impact Of The Ada Final Rule On Wellness Program Regulation And A Proposal For A Zero-Incentive Rule, Stefanie Brody

Saint Louis University Journal of Health Law & Policy

The Equal Employment Opportunity Commission (EEOC) recently amended wellness program regulation under 29 C.F.R. § 1630.14 of the Americans with Disabilities Act (ADA). Amidst criticism of the new rule, this article proposes the EEOC return to a zero-incentive policy for voluntary wellness programs that include disability-related inquiries or medical examinations. First, it reviews existing literature on wellness programs and the ADA, highlighting the legal and ethical challenges facing American workers with disabilities. Then, it explores the latest case law, illustrating the effects of the new rule compared to the proposal. By eliminating the thirty percent incentive limit and redefining “voluntary” …

Charting The Middle Course: An Argument For Robust But Well-Tailored Health Care Discrimination Protection For The Transgender Community, John E. Farmer

Georgia Law Review

Section 1557 of the Patient Protection and Affordable
Care Act offers sweeping discriminationprotections for
patients, applicable to both health insurers and health
care providers who receive federal funding or are
subject to federal administration. Placing itself in the
canon of federal antidiscriminationlaws, Section 1557
incorporates Title IX of the Education Amendments of
1972 to prohibit discrimination on the basis of sex.
Just how sweeping this aspect of Section 1557s
prohibitions is has been the subject of controversy
exemplified in litigation in the federal courts, as well as
in the starkly contrasting views of two presidential
administrations. The Department of Health …

Reproductive Selection Bias, Lauren R. Roth

Scholarly Works

Decades after the advent of assisted reproductive technology (ART) that allows prospective parents to deselect embryos with grave genetic illnesses – a procedure called preimplantation genetic diagnosis (PGD) – it remains a tool largely of upper class whites. In the wake of the Supreme Court’s decision in Whole Woman’s Health v. Hellerstedt, I argue that the time has come to focus on access in this area of reproductive rights. The next logical step is to rebut the presumption that reproductive liberty is only a negative right that prevents government interference with decisions about whether and how to procreate or not …

Certificate Of Need In The Post-Affordable Care Act Era, Emily Whelan Parento

Kentucky Law Journal

Certifcate of need ("CON") programs were conceived approximately fifty years ago as supply constraint mechanisms for healthcare services, in an environment that is essentially unrecognizable today. Every aspect of the healthcare landscape has changed dramatically, particularly in the years since the enactment of the Affordable Care Act. The historical rationales in support of CON programs have been vigorously questioned by scholars across disciplines, roundly criticized by the federal government, and largely disproven by research. Yet the status quo persists with thirty-five states retaining CON laws, due in large part to a combination of entrenched interests and polrical inertia that prevents …

A Global Vaccine Injury Compensation System, Sam F. Halabi, Saad B. Ommer

Faculty Publications

Vaccines are extremely safe and harm is rare. Worldwide, more than 30000 vaccine doses are delivered per second through routine immunization programs, which, in turn, prevent an estimated 2 million to 3 million deaths annually. Yet the specter of vaccine injury plays a central role in vaccine access and will continue to do so as vaccine technologies evolve.

Zika, Pregnancy, And The Law, Sam F. Halabi

Faculty Publications

This Essay situates a crucial component of the public health response to Zika - the effort to develop a safe and effective vaccine - within the broader literature. It does so in an effort to highlight the need to revisit the relationship between law and pregnancy - not only in the areas legal scholars have prioritized so far, but also in the context of routine and emergency maternal health, which has heretofore been largely assumed to be governed by straightforward norms and practices based on medical evidence and physician ethics. In fact, whereas the current literature tends to assume or …

Unbefriended And Unrepresented: Better Medical Decision Making For Incapacitated Patients Without Healthcare Surrogates, Thaddeus Pope

Faculty Scholarship

How should we make medical decisions for incapacitated patients who have no available legally-authorized surrogate decision maker? Because these patients lack decision making capacity, they cannot authorize treatment themselves. Because they lack a surrogate, nobody else can authorize treatment either. Clinicians and researchers have referred to these individuals as “adult orphans” or as “unbefriended,” “isolated,” or “unrepresented” patients. Clinicians and researchers have also described them as “unimaginably helpless,” “highly vulnerable,” and as the “most vulnerable,” because “no one cares deeply if they live or die.”

The persistent challenges involved in obtaining consent for medical treatment on behalf of these individuals …

Dental Board Of California, Jena Scarborough, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

Department Of Managed Health Care, Jennifer Pardue, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.

Board Of Pharmacy, Mariam J. Saleh, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

Medical Board Of California, Kayla Watson, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.

Board Of Registered Nursing, Ashkan Hayatdavoudi, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

A Deliberate Departure: Making Physician-Assisted Suicide Comfortable For Vulnerable Patients, Browne C. Lewis

Law Faculty Articles and Essays

This Article is divided into four parts. Part I discusses the history and evolution of the "right to die movement" in the United States. The current legal landscape in the United States is examined in Part II. In Part III, I analyze some of the relevant ethical concerns caused by the availability of physician-assisted suicide. My analysis primarily focuses on the Oregon statutes because it is the oldest physician-assisted suicide law in the United States and has served as a model for laws in the United States and abroad. For example, Lord Falconer's Bill, which was defeated by the British …

With Great Power Comes No Responsibility: The Tragedy And The Irony Of Erisa Preemption, Jessica Frenkel

University of Colorado Law Review

Under the current health care financing regime, managed care organizations have significant power to determine patients' care but no legal responsibility when they use that power to pursue profits and harm patients. Managed care organizations are shielded from liability because the Employee Retirement Income Security Act of 1974 (ERISA) preempts state causes of action and does not provide a comparable remedy. This Comment attempts to restart a conversation about the dangers of allowing managed care organizations to retain significant power over patient care without any risk of liability of an especially vulnerable subgroup of patients: the severely mentally ill. It …

Health Law, Public Law, And Social Justice, Sidney D. Watson

Saint Louis University Law Journal

I have taught Health Law for almost three decades. In the early years, the course was primarily about private law, the application of contract and tort principles in the context of health insurance coverage and medical care. Federal law of Medicare, Medicaid, EMTALA, and federal civil rights laws always made an appearance. Other federal statutes were added as they came along: HIPAA, the Americans with Disabilities Act, and GINA. Over the years, the course focused more and more on federal statutes until the passage of the Affordable Care Act (“ACA”) in 2010 completed the transition

Health law is now a …

Redefining Medical Care, Lauren R. Roth

Scholarly Works

President Donald J. Trump has said he will replace the Affordable Care Act (ACA) with health savings accounts (HSAs). Conservatives have long preferred individual accounts to meet social welfare needs instead of more traditional entitlement programs. The types of “medical care” that can be reimbursed through an HSA are listed in § 213(d) of the Internal Revenue Code (Code) and include expenses “for the diagnosis, cure, mitigation, treatment, or prevention of disease, or for the purpose of affecting any structure or function of the body.”

In spite of the broad language, regulations and court interpretations have narrowed this definition substantially. …

Remedying Stigma-Driven Health Disparities In Sexual Minorities, Valarie K. Blake

Law Faculty Scholarship

No abstract provided.

Disparities In Private Health Insurance Coverage Of Skilled Care, Stacey A. Tovino

Faculty Articles

This article compares and contrasts public and private health insurance coverage of skilled medical rehabilitation, including cognitive rehabilitation, physical therapy, occupational therapy, speech-language pathology, and skilled nursing services (collectively, skilled care). As background, prior scholars writing in this area have focused on Medicare coverage of skilled care and have challenged coverage determinations limiting Medicare coverage to beneficiaries who are able to demonstrate improvement in their conditions within a specific period of time (the Improvement Standard). By and large, these scholars have applauded the settlement agreement approved on 24 January 2013, by the U.S. District Court for the District of Vermont …

Editor, "Health Care Law And The Rights Of Individuals With Disabilities", Elizabeth Pendo

All Faculty Scholarship

People with disabilities are vulnerable. They carry high risk for poor health and health outcomes. As a group, they experience social disadvantages such as poverty, underemployment and unemployment, isolation, and discrimination at a higher rate than the general population. They also face multiple barriers to quality health care and report poorer health status than people without disabilities. This Special Issue will explore the key health disparities and barriers to health care experienced by people with disabilities, and explore the legal, ethical, and social issues they raise. It will investigate the legal requirements of the Americans with Disabilities and other antidiscrimination …

The Priority Review Voucher Program At The Fda: From Neglected Tropical Diseases To The 21st Century Cures Act, Ana Santos Rutschman

All Faculty Scholarship

The priority review voucher program at the Food and Drug Administration (FDA) was established in 2007 to incentivize research and development (R&D) in traditionally underfunded diseases.1 While shrouded in controversy and criticism, the program has recently been bolstered by the passage of the 21st Century Cures Act,2 which prevented the vouchers from sunsetting in late 2016 and furthered the overall scope of the program.3 As it reaches the end of its first decade, this Article discusses the impact of the program, with a focus on recent developments. The Article builds on literature suggesting that the voucher program has been ineffective …

Lessons From Ferguson And Beyond: Bias, Health, And Justice, Sidney D. Watson

All Faculty Scholarship

August 9, 2014, Michael Brown, an 18-year-old African American teen, killed by police in Ferguson, Missouri.

November 22, 2014, Tamir Rice, a 12-year-old African American child, killed by police in Cleveland, Ohio.

April 4, 2015, Walter Scott, a 50-year-old African American man, killed by police in Charlotte, North Carolina.

November 15, 2015, Jamar Clark, a 24-year-old African American man, killed by police in Minneapolis, Minnesota.

July 6, 2016, Philando Castile, a 32-year-old African American man, killed by police in Falcon Heights, Minnesota.

The list of Black men and women killed by police goes on and seems to grow by the …