Health Law and Policy Commons^™

Covid-19 And Rule 10b-5, Allan Horwich

University of Richmond Law Review

The COVID-19 pandemic presented wide-ranging challenges for businesses. Not the least of these is compliance with federal securities laws, including the prohibition—most notably under SEC Rule 10b-5—on materially deceptive statements made to the public. Both the SEC, in its role as enforcer of the law, and private parties, seeking to represent classes of aggrieved investors, have filed complaints asserting that corporations and others have engaged in deception of investors regarding matters pertaining to COVID-19. Some of these claims relate to disclosures regarding testing kits for the virus as well as development of vaccines. Other complaints allege faulty disclosure on the …

Mobile Methadone Clinics: A Necessary Step In Fighting The Opioid Epidemic, Laurel E. Via

University of Richmond Law Review

Part I of this Article will discuss the rise in opioid use disorder, the need for effective treatment, and the utility of methadone maintenance treatment options, as well as the history of the ban on mobile clinics. Part II will discuss the NPRM issued by the DEA on February 26, 2020, and explain the likely impact of the rule. Part III will provide an overview of the NPRM in its current form, explain its likely impact as written and show that mobile clinics are effective treatment options, and then argue that while a great start, the NPRM should be amended …

The Federal Law Clerk Hiring Pilot And The Coronavirus Pandemic, Carl W. Tobias

Law Faculty Publications

Just when law students attained a comfort level with the arcane intricacies of the federal law clerk employment process, as increasingly exacerbated by the second year of an experimental hiring pilot plan, the coronavirus attacked the country and has been ravaging it ever since. To date, the virus has inflicted the most profound harm on the jurisdictions that comprise all of the “coastal elite circuits” that span the District of Columbia north to Maine, as well as the United States Courts of Appeals for the Seventh and Ninth Circuits, which apply the pilot. This piece examines impacts that the coronavirus’ …

Key Expert Stakeholder Perceptions Of The Law Of Genomics: Identified Problems And Potential Solutions, Lauren E. Clatch

Law Faculty Publications

The law on human genomics in the United States is currently in transition and under debate. The rapid evolution of the science, burgeoning clinical research, and growing clinical application pose serious challenges for federal and state law. Newer genomic assays, such as gene panels, whole exome and whole genome sequencing that can assess many or all of a patient’s genetic variants are different from former genetic assays that consist of assessing for variants in specific genes that indicate risk for medical conditions and for single-gene Mendelian disorders. Overall, single-gene genetic testing has primarily been used for risk prediction, disease diagnosis, …

Access Before Evidence And The Price Of The Fda’S New Drug Authorities, Erika Lietzan

University of Richmond Law Review

Sometimes drug innovation seems to happen in reverse. Patients enjoy a treatment for years even though the treatment has not been approved by the FDA or proven safe and effective to the FDA’s standards. (Sometimes this happens because the FDA has declined to take enforcement action.) The agency encourages companies to perform the work necessary to satisfy the United States “gold standard” for new drug approval, however, by promising exclusivity in the marketplace. When a company does this work, at considerable expense, the results are predictable. The new drug is expensive, and patients and payers (and sometimes policymakers) are outraged. …

Unjust Timing Limitations In Genetic Malpractice Cases, Lauren E. Clatch

Law Faculty Publications

As genomic data are increasingly being collected and applied in clinical care, physicians, laboratories, and other health care providers are more frequently being sued for alleged medical malpractice or negligence. Because the genetic underpinnings of an existing or future health condition may not be immediately apparent, such cases sometimes raise unique timing issues involving the applicable statute of limitations, statute of repose, or statutory notification requirements. Although these timing limitations on when a lawsuit can be brought have important policy rationales and justifications, such as helping to protect providers from open-ended liability, their application to genetic liability cases may sometimes …

On Opioids And Erisa: The Urgent Case For A Federal Ban On Discretionary Clauses, Katherine T. Vukadin

University of Richmond Law Review

The American opioid epidemic cuts across all social divisions, touching the employed and unemployed. Those with private health insurance are one of the fastest-growing affected groups, but this group struggles most to get care. Despite their insured status, the privately-insured received treatment at half the rate of those with Medicaid and at even lower rates than the uninsured. This article focuses on a significant barrier to treatment for those in employer sponsored benefit plans: the discretionary clause. A discretionary clause grants the decision maker broad latitude and ensures that any federal court review is deferential. Claims processing in such a …

The Burden Of A Good Idea: Examining The Impact Of Unfunded Federal Regulatory Mandates On Medicare Participating Hospitals, Rachel Juhas Suddarth

Law Faculty Publications

Health care costs are on the rise. In 1960, the United States spent $9 billion on hospital care. Since then, hospital related spending has grown exponentially. In 2015, the United States spent over $1 trillion on hospital care, with $359.9 billion of those payments coming from the federal Medicare program for the aged and disabled. Researchers have long tried to understand the exact causes of rising health care costs. While many have closely examined the costs associated with population demographics, medical innovation, prescription drug costs, overutilization of services, and fraud or abuse, there is one driving force that does not …

Modernizing Disability Income For Cancer Survivors, Ann C. Hodges

Law Faculty Publications

The medical progress in cancer treatment is worthy of celebration, as survivors of many cancers are living longer. This good news, however, comes with challenges for those survivors. Empirical evidence from researchers at cancer centers demonstrates the devastating impact that cancer has on employment, resulting in serious financial stress for survivors and their families. My previous research used this empirical data to recommend changes in employment laws to meet the need of survivors to maintain employment. This article builds on the prior research by using the empirical evidence of the employment effects of cancer to recommend changes in the disability …

The Limits Of Reading Law In The Affordable Care Act Cases, Kevin C. Walsh

Law Faculty Publications

One of the most highly lauded legacies of Justice Scalia's decades-long tenure on the Supreme Court was his leadership of a movement to tether statutory interpretation more closely to statutory text. His dissents in the Affordable Care Act cases- National Federation of Independent Business v. Sebelius and King v. Burwell- demonstrate both the nature and the limits of his success in that effort.

These were two legal challenges, one constitutional and the other statutory, that threatened to bring down President Obama's signature legislative achievement, the Patient Protection and Affordable Care Act. Both times the Court swerved away from a direct …

Private Right Of Action Jurisprudence In Healthcare Discrimination Cases, Allison M. Tinsey

Law Student Publications

Section 1557 of the Affordable Care Act provides that entities covered by the Act which receive federal funds are prohibited from discriminating on the basis of race, color, national origin, sex, age or disability. But since the provision’s enactment and the U.S. Department of Health and Human Services’ promulgation of a regulation creating a private right of action for alleged discrimination under the Act, courts have disagreed on whether a private right of action exists to enforce Section 1557. This Comment summarizes the courts’ confusion in applying the holding of Alexander v. Sandoval and Chevron deference to the nondiscrimination provision …

“Pay To Prescribe”: A Case For Strengthened Enforced Of The Fcpa In The Global Pharmaceutical Industry In 2017 And Beyond, John T. Jessee Jr.

Law Student Publications

This paper will use recent Foreign Corrupt Practices Act (FCPA) enforcement actions to argue that a revamped and increased enforcement of the FCPA’s anti-bribery provisions in the pharmaceutical industry will be an absolutely critical task in 2017 and beyond, as there is much work to be done in cleaning up the industry. The paper will begin by outlining a brief history of the FCPA and examining its basic enforcement provisions. It will then examine the nature of the pharmaceutical industry’s bribery through a detailed analysis of several recent high profile enforcement cases within the industry. Lastly, the paper will propose …

Regulating Human Germline Modification In Light Of Crispr, Sarah Ashley Barnett

University of Richmond Law Review

No abstract provided.

Regulating Healthcare Robots: Maximizing Opportunities While Minimizing Risks, Drew Simshaw, Nicolas Terry, Kris Hauser, M.L. Cummings

Richmond Journal of Law & Technology

Some of the most dynamic areas of robotics research and development today are healthcare applications. Robot-assisted surgery, robotic nurses, in-home rehabilitation, and eldercare robots' are all demonstrating rapidly iterating innovation. Rising healthcare labor costs and an aging population will increase demand for these human surrogates and enhancements. However, like many emerging technologies, robots are difficult to place within existing regulatory frameworks. For example, the federal Food, Drug, and Cosmetic Act (FD&C Act) seeks to ensure that medical devices (few of which are consumer devices) are safe, the HIPAA Privacy and Security Rules apply to data collected by health care providers …

Reforming Healthcare Reform, Jacqueline Fox

University of Richmond Law Review

No abstract provided.

Purpose And Power Of The Group Tax Exemption In Health Care, Marie Yascko-Rosado

Richmond Journal of Global Law & Business

This article argues that the group tax exemption and consolidated group returns provide immense assistance to nonprofit healthcare organizations, because of simplicity, financial benefits and efficiency benefits. Part III will discuss what it means to be a tax-exempt entity and the legal basis for its existence, the historical basis of the exemption and its various rationales including relief of government burden, subsidy and income measurement theories. Part IV will explain the tax-exempt status in health care, the effects of the Affordable Care Act on the uninsured population, and key differences between for-profit entities and non-profit entities. Part V will both …

A Physician's Apology: An Argument Against Statutory Protection, Nancy L. Zisk

Richmond Public Interest Law Review

After a review of a physician's ethical duty to disclose and the empirical evidence of how open and honest communication between patient and physician actually benefits both the patient and the treating physician, the paper questions whether apologies by health care providers need the protection afforded by these laws. Section II reviews the history of the medical profession's tendency toward silence and the reasons for that silence. Section III examines the state statutes passed to encourage the breaking of this silence. Section IV reviews the state rules of evidence that have traditionally been applied to determine whether or not statements …

A Physician's Apology: An Argument Against Statutory Protection, Nancy L. Zisk

Richmond Journal of Law and the Public Interest

After a review of a physician's ethical duty to disclose and the empirical evidence of how open and honest communication between patient and physician actually benefits both the patient and the treating physician, the paper questions whether apologies by health care providers need the protection afforded by these laws. Section II reviews the history of the medical profession's tendency toward silence and the reasons for that silence. Section III examines the state statutes passed to encourage the breaking of this silence. Section IV reviews the state rules of evidence that have traditionally been applied to determine whether or not statements …

Can I Call You Back? A Sustained Interaction With Biospecimen Donors To Facilitate Advances In Research, Jonathan S. Miller

Richmond Journal of Law & Technology

"For the cure." This statement resonates throughout society and offers a simple reasoning for the conduct of biomedical research. It provides a strong impetus for advocates of biomedical research to pursue appropriations to support research hypotheses, advanced medical technologies, and targeted therapeutic strategies. Answering sophisticated medical questions, however, requires researchers and clinicians to have an adequate supply of materials necessary to facilitate their research endeavors. These materials-commonly referred to as biospecimens- may include frozen human embryos, tissue specimens, blood samples, buccal swabs, or exhaled breath condensate, all of which may be collected and stored in biobanks.

Working With Cancer: How The Law Can Help Survivors Maintain Employment, Ann C. Hodges

Law Faculty Publications

Advances in cancer treatment are saving lives, but along with the benefits come challenges. Millions of cancer survivors of working age need to support themselves and their families. This Article looks at the impact of cancer on employment starting with the empirical evidence gathered by researchers affiliated with medical centers. This empirical research provides a base, not previously explored in the legal literature, for assessing the existing laws dealing with cancer and employment (or unemployment). Viewing the law through this lens, which reveals the complex relationship between cancer and employment, exposes both the promise and the weakness of existing laws …

Health Care Law, Sean P. Byrne, Garrett Hooe

University of Richmond Law Review

No abstract provided.

Abortion And The Constitutional Right (Not) To Procreate, Mary Ziegler

University of Richmond Law Review

No abstract provided.

Silence Is Golden...Except In Health Care Philanthropy, Stacey A. Tovino

University of Richmond Law Review

No abstract provided.

Renewed Commitment: The Latest Chapter In Reforming Virginia's Mental Health System, The Honorable Jennifer L. Mcclellan

Richmond Journal of Law and the Public Interest

In the wake of the highly publicized Virginia Tech tragedy, the 2008 General Assembly Session adopted mental health reforms that focused on the provision of emergency services during the detention and commitment process, and an increase in funding to implement these reforms and strengthen emergency services. Despite the reforms, the issue of inadequate capacity to meet the increasing demand for mental health services remains in a number of key areas, including emergency services and a decline in in-patient psychiatric bed capacity while population growth continues.

Veterans Treatment Court: A Hand Up Rather Than Lock Up, Tabatha Renz

Richmond Public Interest Law Review

There has been a gradual national shift toward rehabilitation within the justice system. This has been especially important for veterans who make up only 8% of the total population, but account for 10% of those with criminal records. Recognizing that the traditional justice system is not equipped to handle cases of individuals whose underlying cause of offense is combat trauma, there has been a call to expand the Veterans Treatment Court ("VTC") program as an alternative for offenders who are veterans of the armed forces. This issue has been compounded by over a decade of war in Iraq and Afghanistan, …

An Analysis Of The Political And Legal Debates Concerning Medicaid Expansion In Virginia, Rick Mayes Ph.D, Benjamin Paul

Richmond Public Interest Law Review

The Supreme Court's historic June 2012 ruling regarding the Affordable Care Act (ACA) in National Federation of Independent Business v. Sebelius set the stage for a massive federalism battle over Medicaid expansion in the United States. The original language of the Act was intended to nationalize Medicaid by having every state expand their program's eligibility to all individuals up to 138% of the federal poverty level. This would have significantly reshaped Medicaid, a joint federal-state health insurance program, into a universal entitlement for all low-income citizens. Currently, Medicaid eligibility varies dramatically from state to state. The Court held that the …

Literacy, Poverty, And Brain Development: Toward A New, Place-Based Educational Intervention, Michael R. Hilton

Richmond Public Interest Law Review

This paper provides an overview of emerging research focused on how living in an area of concentrated poverty can impact brain development and explores some possible applications of this research to education policy. One of the key findings is that state and federal policy-makers may need to adopt programs that integrate educational policy with housing and planning policy in order to protect and fulfill each child's educational rights. In order to impress upon readers the scale of the nation's current educational failures and the need for a significant change in policy, this paper first addresses adult illiteracy in the United …

Renewed Commitment: The Latest Chapter In Reforming Virginia's Mental Health System, The Honorable Jennifer L. Mcclellan

Richmond Public Interest Law Review

In the wake of the highly publicized Virginia Tech tragedy, the 2008 General Assembly Session adopted mental health reforms that focused on the provision of emergency services during the detention and commitment process, and an increase in funding to implement these reforms and strengthen emergency services. Despite the reforms, the issue of inadequate capacity to meet the increasing demand for mental health services remains in a number of key areas, including emergency services and a decline in in-patient psychiatric bed capacity while population growth continues.

Veterans Treatment Court: A Hand Up Rather Than Lock Up, Tabatha Renz

Richmond Journal of Law and the Public Interest

There has been a gradual national shift toward rehabilitation within the justice system. This has been especially important for veterans who make up only 8% of the total population, but account for 10% of those with criminal records. Recognizing that the traditional justice system is not equipped to handle cases of individuals whose underlying cause of offense is combat trauma, there has been a call to expand the Veterans Treatment Court ("VTC") program as an alternative for offenders who are veterans of the armed forces. This issue has been compounded by over a decade of war in Iraq and Afghanistan, …

An Analysis Of The Political And Legal Debates Concerning Medicaid Expansion In Virginia, Rick Mayes Ph.D, Benjamin Paul

Richmond Journal of Law and the Public Interest

The Supreme Court's historic June 2012 ruling regarding the Affordable Care Act (ACA) in National Federation of Independent Business v. Sebelius set the stage for a massive federalism battle over Medicaid expansion in the United States. The original language of the Act was intended to nationalize Medicaid by having every state expand their program's eligibility to all individuals up to 138% of the federal poverty level. This would have significantly reshaped Medicaid, a joint federal-state health insurance program, into a universal entitlement for all low-income citizens. Currently, Medicaid eligibility varies dramatically from state to state. The Court held that the …