Administrative Law Commons^™

What Can State Medical Boards Do To Effectively Address Serious Ethical Violations?, Tristan Mcintosh, Elizabeth Pendo, Heidi A. Walsh, Kari A. Baldwin, Patricia King, Emily E. Anderson, Catherine V. Caldicott, Jeffrey D. Carter, Sandra H. Johnson, Katherine Matthews, William A. Norcross, Dana C. Shaffer, James M. Dubois

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State Medical Boards (SMBs) can take severe disciplinary actions (e.g., license revocation or suspension) against physicians who commit egregious wrongdoing in order to protect the public. However, there is noteworthy variability in the extent to which SMBs impose severe disciplinary action. In this manuscript, we present and synthesize a subset of 11 recommendations based on findings from our team’s larger consensus-building project that identified a list of 56 policies and legal provisions SMBs can use to better protect patients from egregious wrongdoing by physicians.

Abortion Pills, David S. Cohen, Greer Donley, Rachel Rebouché

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Abortion is now illegal in roughly a third of the country, but abortion pills are more widely available than ever before. Though antiabortion advocates and legislators are attacking pills with all manner of strategies, clinics, websites, and informal networks are openly facilitating the distribution of abortion pills, legally and illegally, across the United States. This Article is the first to explain this defining aspect of the post-Roe environment and the novel issues it raises at the level of state law, federal policy, and on-the-ground advocacy.

This Article first details antiabortion strategies to stop pills by any means necessary. These tactics …

Medication Abortion Exceptionalism, Greer Donley

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Restrictive state abortion laws garner a large amount of attention in the national conversation and legal scholarship, but less known is a federal abortion policy that significantly curtails access to early abortion in all fifty states. The policy limits the distribution of mifepristone, the only drug approved to terminate a pregnancy so long as it is within the first ten weeks. Unlike most drugs, which can be prescribed by licensed healthcare providers and picked up at most pharmacies, the Food and Drug Administration only allows certified providers to prescribe mifepristone, and only allows those providers to distribute the drug to …

Substance Use Disorder Discrimination And The Cares Act: Using Disability Law To Inform Part 2 Rulemaking, Kelly K. Dineen, Elizabeth Pendo

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Substance use disorder (SUD) is a chronic health condition—like people with other chronic health conditions, people with SUDs experience periods of remission and periods of exacerbation or recurrence. Unlike people with most other chronic conditions, people with SUDs may be more likely to garner law enforcement attention than medical attention during a recurrence. They are also chronically disadvantaged by pervasive social stigma, discrimination, and structural inequities. The COVID-19 pandemic has had devastating consequences for people with SUDs, who are at higher risk for both contracting the SARS-CoV-19 virus and experiencing poorer outcomes. Meanwhile, there are early indications that pandemic conditions …

Regulation Of Encapsulated Placenta, Greer Donley

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The practice of placenta encapsulation is rapidly growing. It typically involves post-partum mothers consuming their placentas as pills in the months after childbirth. The perceived benefits include improved mood and energy, reduced bleeding and pain, and greater milk supply. But these effects are unproven, and consumption comes with health risks. The rise of this trend has sparked a vigorous debate in the recent medical literature, but this Article is the first to consider the legal implications of placenta encapsulation. This Article examines whether FDA should regulate encapsulated placenta, and if so, whether it should be regulated as a drug, supplement, …

The Costs Of Uncertainty: The Doj’S Stalled Progress On Accessible Medical Equipment Under The Americans With Disabilities Act, Elizabeth Pendo

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Imagine seeking medical care for serious pressure sores for a year, but your doctor never examining the sores because you could not get on the examination table in her office. Or imagine going more than fifteen years without an annual well-woman examination for the same reason, or your doctor guessing at the right dosage for a prescription because there was no scale that she could use to weigh you.

Although these scenarios may be difficult for many to imagine, they are common experiences for individuals with mobility disability. The Trump administration’s attacks on the Patient Protection and Affordable Care Act …

Drug Approval In A Learning Health System, W. Nicholson Price

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The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …

Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar

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In an ambitious effort to slow the growth of health care costs, the Affordable Care Act created the Center for Medicare and Medicaid Innovation (CMMI) and armed it with broad authority to test new approaches to reimbursement for health care (payment models) and delivery-system reforms. CMMI was meant to be the government’s innovation laboratory for health care: an entity with the independence to break with past practices and the power to experiment with bold new approaches. Over the past year, however, the Department of Health and Human Services (HHS) has quietly hobbled CMMI, imperiling its ability to generate meaningful data …

The Broken Medicare Appeals System: Failed Regulatory Solutions And The Promise Of Federal Litigation, Greer Donley

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The Medicare Appeals System is broken. For years, the System has been unable to accommodate a growing number of appeals. The result is a backlog so large that even if no new appeals were filed, it would take the System a decade or more to empty. Healthcare providers wait many years for their appeals to be heard before an Administrative Law Judge (ALJ), and because the government recoups providers' Medicare payments while they wait, the delays cause them serious financial harm. Even worse, providers are more likely than not to prevail before the ALJ, proving that the payment should never …

Trouble On The Exchanges — Does The United Owe Billions To Health Insurers?, Nicholas Bagley

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Yet another bruising fight has erupted over health care reform. On September 9, 2016, the Obama administration offered to open settlement negotiations with health insurers that have sued the United States to recover billions of dollars that they claim they are owed. Congressional Republicans are incensed, believing that any settlement would illegally squander taxpayer dollars in a lastgasp effort to save the Affordable Care Act (ACA).

Encouraging Maternal Sacrifice: How Regulations Governing The Consumption Of Pharmaceuticals During Pregnancy Prioritize Fetal Safety Over Maternal Health And Autonomy, Greer Donley

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Pregnant women are routinely faced with the stressful decision of whether to consume needed medications during their pregnancies. Because the risks associated with pharmaceutical drug consumption during pregnancy are largely unknown, pregnant women both inadvertently consume dangerous medications and avoid needed drugs. Both outcomes are harmful to pregnant women and their fetuses. This unparalleled lack of drug safety information is a result of ill-conceived, paternalistic regulations in two areas of the law: regulations governing ethical research in human subjects and regulations that dictate the required labels on drugs. The former categorizes pregnant women as “vulnerable” and thus precludes them from …

Unearthing The Lost History Of Seminole Rock, Amy J. Wildermuth, Sanne H. Knudsen

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In 1945, the Supreme Court blessed a lesser known type of agency deference in Bowles v. Seminole Rock. Also known as Auer deference, it affords deference to agency interpretations of their own regulations. Courts regularly defer to agencies under this doctrine, regardless of where the interpretations first appear or how long-standing they are. Recently members of the Supreme Court have signaled a willingness to reconsider, and perhaps jettison, Seminole Rock. We agree. Seminole Rock has been widely accepted but surprisingly disconnected from any analysis of its origins and justifications. This Article — the first historical explication of Seminole …

The Legality Of Delaying Key Elements Of The Aca., Nicholas Bagley

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Under the Affordable Care Act (ACA), the employer mandate — the requirement that most employers offer health insurance to their workers or pay a tax penalty — was scheduled to go into effect on January 1, 2014. Last summer, however, the Obama administration announced that it was delaying the mandate for a year. The administration has now extended the delay for midsize firms until 2016.

A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley

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Governmental regulation of human subjects research involves unique agency action. It delegates power to non-expert committees, Institutional Review Boards, to decide whether research protocols are "ethical" according to vague federal regulations. Without IRB approval, the protocol cannot be investigated. The empirical evidence regarding this system demonstrates that IRBs render deeply inconsistent and inaccurate outcomes. This Article argues that the lack of due process in the IRB system is to blame for such arbitrary agency action. By juxtaposing the levels of process required for IRB approval or research with FDA new drug approval--agency action involving similar interests--this Article highlights that IRBs …

Enlightened Regulatory Capture, David Thaw

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Regulatory capture generally evokes negative images of private interests exerting excessive influence on government action to advance their own agendas at the expense of the public interest. There are some cases, however, where this conventional wisdom is exactly backwards. This Article explores the first verifiable case, taken from healthcare cybersecurity, where regulatory capture enabled regulators to harness private expertise to advance exclusively public goals. Comparing this example to other attempts at harnessing industry expertise reveals a set of characteristics under which regulatory capture can be used in the public interest. These include: 1) legislatively-mandated adoption of recommendations by an advisory …

Essential Health Benefits And The Affordable Care Act: Law And Process, Nicholas Bagley, Helen Levy

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Starting in 2014, the Affordable Care Act (ACA) will require private insurance plans sold in the individual and small-group markets to cover a roster of "essential health benefits." Precisely which benefits should count as essential, however, was left to the discretion of the Department of Health and Human Services (HHS). The matter was both important and controversial. Nonetheless, HHS announced its policy by posting on the Internet a thirteen-page bulletin stating that it would allow each state to define essential benefits for itself. On both substance and procedure, the move was surprising. The state-by-state approach departed from the uniform, federal …

Bedside Bureaucrats: Why Medicare Reform Hasn't Worked, Nicholas Bagley

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Notwithstanding its obvious importance, Medicare is almost invisible in the legal literature. Part of the reason is that administrative law scholars typically train their attention on the sources of external control over agencies’ exercise of the vast discretion that Congress so often delegates to them. Medicare’s administrators, however, wield considerably less policy discretion than the agencies that feature prominently in the legal commentary. Traditional administrative law thus yields slim insight into Medicare’s operation. But questions about external control do not—or at least they should not—exhaust the field. An old and often disregarded tradition in administrative law focuses not on external …

Shifting The Conversation: Disability, Disparities And Health Care Reform, Elizabeth Pendo

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In keeping with the theme of this symposium, I would like to invite you to consider health care reform as a political shift in our thinking about the barriers and inequalities experienced by people with disabilities in our health care system. Traditionally, when these issues have been addressed, the predominant approach has been through a civil rights framework, specifically the Rehabilitation Act of 1973' and the American with Disabilities Act of 1990 (ADA).2 Now, the Patient Protection and Affordable Care Act of 2010 (PPACA) offers a new approach. This essay will outline the barriers to health and health care experienced …

Reducing Disparities Through Health Care Reform: Disability And Accessible Medical Equipment, Elizabeth Pendo

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People with disabilities face multiple barriers to adequate health care and report poorer health status than people without disabilities. Although health care institutions, offices, and programs are required to be accessible, people with disabilities are still receiving unequal and in many cases inadequate care. The 2009 report by the National Council on Disability, The Current State of Health Care for People with Disabilities, reaffirmed some of these findings, concluding that people with disabilities experience significant health disparities and barriers to health care; encounter a lack of coverage for necessary services, medications, equipment, and technologies; and are not included in the …

Disability, Equipment Barriers And Women’S Health: Using The Ada To Provide Meaningful Access, Elizabeth Pendo

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It is well-known that people with disabilities face multiple barriers to adequate health care, including lower average incomes, disproportionate poverty, and issues with insurance coverage. This article focuses on a more fundamental barrier-one that has not been discussed in the legal literature-inaccessible medical equipment and its effect on the delivery of women's health care to millions of women with disabilities .

Responsible Regulation: A Sensible Cost-Benefit, Risk Versus Risk Approach To Federal Health And Safety Regulation, Steve Calandrillo

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Federal health and safety regulations have saved or improved the lives of thousands of Americans, but protecting our citizens from risk entails significant costs. In a world of limited resources, we must spend our regulatory dollars responsibly in order to do the most we can with the money we have. Given the infeasibility of creating a risk-free society, this paper argues that a sensible cost-benefit, risk versus risk approach be taken in the design of U.S. regulatory oversight policy. The goal should always be to further the best interests of the nation, rather than to satisfy the narrow agenda of …

Reply To Comments On The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges

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A brief reply is in order to clarify our position on the patenting of research tools. We stand by the statement that "there are reasons to be wary of patents on research tools," but that statement should not be understood as a broad condemnation of patents on research tools in all contexts. Indeed, immediately after the cited language our opinion letter acknowledges that withholding patent protection from research tools could undermine private incentives to develop research tools and to make them available to investigators or lead to greater reliance on trade secrecy. Unlike the government, which purports to pursue patent …

Opinion Letter As To The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges

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You have asked for our legal opinion on the patentability of inventions claimed in U.S. patent applications 07/716,831, filed June 21, 1991 (the '831 application, or .'831"), 07/837,195, filed September 25, 1992 ("'195"), and 07/952,911, filed February 12, 1993 (."911"), all filed in the name of Craig Venter and others and assigned to the National Institutes of Health "(NIH)." We understand that NIH has abandoned these patent applications and has no present intention of filing similar applications in the future, but that NIH remains interested in the patenting of human DNA sequences from a broader public policy perspective. We have …