This article marks the 30th anniversary of the Supreme Court of New Jersey's Baby M decision by offering a critical analysis of surrogacy policy in the United States. Despite fundamental changes in both science and society since the case was decided, state courts and legislatures remain bitterly divided on the legality of surrogacy. In arguing for a more uniform, permissive legal posture toward surrogacy, the article addresses five central debates in the surrogacy literature.

First, should the legal system accommodate those seeking conception through surrogacy, or should it prohibit such arrangements? Second, if surrogacy is permitted, what steps can be taken to minimize the potential exploitation of women who are willing to rent their wombs for income? Third, what criteria should govern the eligibility to serve as a surrogate mother and an intended parent? Fourth, what principle(s) should serve as the basis for determining the parentage of children born through surrogacy? Fifth, is regulatory uniformity in the surrogacy realm desirable? Is it achievable?

The article concludes that courts and legislatures should accept the validity of surrogacy contracts, determine parentage according to intent, and identify transparent criteria for the eligibility of both surrogates and intended parents.

Food policy action on the state and local levels is necessary and important for at least two reasons. First, the complexity and breadth of our nation's food system requires layered policy and regulation: the system's functioning needs both national uniformity and local distinctions. Second, there are crucial gaps in national regulation that provide rich opportunities for state and local action. These gaps, in areas such as the regulation of antibiotics in animal feed and the oversight of food additives, are not priorities of the federal agencies that oversee food. Although the Food and Drug Administration (FDA) has made nutrition policy a priority for 2018, the current administration's explicitly anti-regulatory agenda makes it unlikely that it will address these previously under prioritized areas.

Obesity, recognized as a disease in the U.S. and at times as a terminal illness due to associated medical complications, is an American epidemic according to the Centers for Disease Control and Prevention (“CDC”), American Heart Association (“AHA”), and other authorities. More than one third of Americans (39.8% of adults and 18.5% of children) are medically obese. This article focuses on cases of “extreme morbid obesity” (“EMO”)—situations in which death is imminent without aggressive medical interventions, and bariatric surgery is the only treatment option with a realistic possibility of success. Bariatric surgeries themselves are very high risk for EMO patients. Individuals in this state have impeded mobility and are partially, if not entirely, bedridden, highly vulnerable, and dependent upon caregivers who often are enablers feeding their food addictions. The article draws from existing Centers for Medicare and Medicaid Services (“CMS”) and Social Security Administration (“SSA”) policies and procedures for severe obesity treatment and disability benefits. The discussion also encompasses myriad areas in which the law imposes a duty to report on professionals to protect vulnerable individuals from harm from others, and constraints and prohibitions on accelerating the end of life. The article proposes, among other law and policy measures, to introduce an obligation on medical professionals to investigate and report instances of enablement when food addiction has put the lives of individuals at risk of imminent death. The objectives of the proposals are to give providers more leverage to prevent food addiction enablers from impeding treatment and to enable EMO patients to comply with treatment protocols, to save lives and, ironically, to empower enablers to stand firm against the demands of individuals whose lives have been consumed by their food addictions.

In May 2015, the first baby created through an emerging ova technology called AUGMENT, was born in Canada.1 Developed by OvaScience, AUGMENT essentially introduces mitochondria sourced from the genetic mother into her own ovum in order to revitalize the ovum.2 This technology is controversial because OvaScience is a publicly traded company, and it is driven by short-term results, such as earnings;3 and (2) OvaScience did not complete adequate clinical trials before offering AUGMENT to the public.4 Moreover, in its 2014 annual report, OvaScience declared that it was intentionally offering its products in countries where clinical trials are not required.5 The lack of adequate clinical trials is the primary reason underlying the Food and Drug Administration's (“FDA”) prohibition of the technology in the United States.6 Finally, as of August 2018, OvaScience has shifted its research away from AUGMENT, and it only offers it through an “exclusive license to IVF Japan Group in Japan.”7

The 21st Century Cures Act (“Cures Act”) relies on the concept of real-world evidence (“RWE”) to improve the Food and Drug Administration (“FDA”) approval process. This has amplified interest and furthered momentum in applying RWE more broadly, beyond FDA regulation. In this article, we discuss the understandable appeal of RWE's pragmatic application and its many potential benefits. But we also caution that claims about RWE's wide-ranging, ameliorative impact on the health care system are likely overstated.

The real world of RWE is messy and uncertain. Successfully incorporating RWE into regular health care system decision-making, beyond the FDA, faces considerable obstacles and limitations. We review the reasons to be wary about RWE as a game-changer. These concerns including data reliability, insufficient incentives for stakeholders to generate and engage with high-quality RWE, and lack of comprehensive regulatory oversight. In addition, the push for RWE may impact the enforcement of the health care fraud and abuse laws, perhaps not in necessarily positive ways. Increased reliance on RWE may have significant implications for off-label fraud enforcement, further conflating the distinction between claims that are false for reimbursement rather than for scientific purposes.

Live kidney donation involves a delicate balance between saving the most lives possible and maintaining a transplant system that is fair to the many thousands of patients on the transplant waiting list. Federal law and regulations require that kidney allocation be equitable, but the pressure to save patients subject to ever-lengthening waiting times for a transplant has been swinging the balance toward optimizing utility at the expense of justice.

This article traces the progression of innovations created to make optimum use of a patient's own live donors. It starts with the simplest – direct donation by family members – and ends with voucher donations, a very recent and unique innovation because the donor can donate 20 or more years before the intended recipient is expected to need a kidney. In return for the donation, the intended recipient receives a voucher that can be redeemed for a live kidney when it is needed. Other innovations that are discussed include kidney exchanges and list paired donation, which are used to facilitate donor swaps when donor/recipient pairs have incompatible blood types.

The discussion of each new innovation shows how the equity issues build on each other and how, with each new innovation, it becomes progressively harder to find an acceptable balance between utility and justice. The article culminates with an analysis of two recent allocation methods that have the potential to save many additional lives, but also affirmatively harm some patients on the deceased donor waiting list by increasing their waiting time for a life-saving kidney. The article concludes that saving additional lives does not justify harming patients on the waiting list unless that harm can be minimized. It also proposes solutions to minimize the harm so these new innovations can equitably perform their intended function of stimulating additional transplants and extending the lives of many transplant patients.

Basic principles of economics suggest that health insurers should seek to avoid covering sick individuals and attempt to minimize the amount they have to spend if, despite the insurer's best efforts, such individuals enroll in coverage. The drafters of the Affordable Care Act recognized this natural tendency of insurers and put in place multiple provisions aimed at avoiding such behavior. One such tool was the requirement that all health insurers in the individual and small group markets cover an identical, comprehensive set of benefits known as the Essential Health Benefits (“EHBs”). EHBs were designed to ensure that consumers are able to access comprehensive coverage, but also to prevent insurers from trying to avoid high-risk enrollees by designing plans that appeal only to the healthy. Congress did not, however, statutorily define the full package of benefits, instead delegating primary authority for that task to the Department of Health & Human Services (“HHS”). This article argues that HHS has implemented the EHB requirements in a manner that appears structurally incapable of achieving the goals of the statute. By utilizing a vague definition of benefits, allowing benefit substitutions, and failing to limit use of service-level selection tools, HHS has permitted insurers to compete for low-risk insureds, avoid paying for certain high-cost treatments, and prevented consumers from making fully informed purchasing decisions.

A component of the 1965 Medicaid Act, the Institutions for Mental Diseases (“IMD”) Exclusion was supposed to be a remedy for the brutal, dysfunctional mental healthcare system run through state hospitals. In the years since Medicaid was created, the IMD Exclusion has instead barred thousands of those in need of intensive, inpatient treatment from receiving it. As a result, many severely mentally ill individuals are left without adequate care and without a home. They struggle in the street where they are otherized by those in their community and are susceptible to confrontational episodes with law enforcement. Many are ultimately incarcerated, where they are thrust into an abusive environment known to exacerbate mental health issues.

This Note's central contention is that the IMD Exclusion creates an access gap for the poorest Americans who suffer from mental illness. Subsequently, prisons and jails fill that gap to the detriment of those individuals. The Note will proceed first by explaining the IMD Exclusion and how it applies to state-run medical care services and facilities. This Note will discuss the nationwide movement, in the 1950s through the 1960s and ‘70s, to deinstitutionalize notoriously abusive state psychiatric hospitals, a movement that culminated in the passage of the Medicaid Act in 1965, along with the IMD Exclusion. This Note will then shift focus to criticize the practical effects of the IMD Exclusion and its extensive role in the mass incarceration issue today. In doing so, this Note will identify the major weaknesses of the IMD Exclusion and explain how these weaknesses create an access gap for mentally ill persons, while simultaneously making them more vulnerable to contact with the police and the criminal justice system.

Voice in healthcare is crucial because of its ability to improve organizational performance and prevent medical errors. This paper contends that a comparative analysis of voice promotion in the American and German healthcare industries can strengthen a culture of safety in both countries. It provides a brief introduction to the concept of voice in healthcare, including its impact on safety culture, barriers to voice, and the dual influences of confidentiality and transparency on voice promotion policies. It then examines the theoretical basis, practical workings, and legal aspects of voluntary error reporting and error disclosure as avenues for exercising voice in the U.S. and Germany. Finally, it identifies transferable practices that can remedy shortcomings in each country's voice promotion policy.

Healthcare database analyses (claims, electronic health records) have been identified by various regulatory initiatives, including the 21st Century Cures Act and Prescription Drug User Fee Act (“PDUFA”), as useful supplements to randomized clinical trials to generate evidence on the effectiveness, harm, and value of medical products in routine care. Specific applications include accelerated drug approval pathways and secondary indications for approved medical products. Such real-world data (“RWD”) analyses reflect how medical products impact health outside a highly controlled research environment. A constant stream of data from the routine operation of modern healthcare systems that can be analyzed in rapid cycles enables incremental evidence development for regulatory decision-making.

Key evidentiary needs by regulators include 1) monitoring of medication performance in routine care, including the effectiveness, safety and value; 2) identifying new patient strata in which a drug may have added value or unacceptable harms; and 3) monitoring targeted utilization. Four broad requirements have been proposed to enable successful regulatory decision-making based on healthcare database analyses (collectively, “MVET”): Meaningful evidence that provides relevant and context-informed evidence sufficient for interpretation, drawing conclusions, and making decisions; valid evidence that meets scientific and technical quality standards to allow causal interpretations; expedited evidence that provides incremental evidence that is synchronized with the decision-making process; and transparent evidence that is audible, reproducible, robust, and ultimately trusted by decision-makers.

Evidence generation systems that satisfy MVET requirements to a high degree will contribute to effective regulatory decision-making. Rapid-cycle analytics of healthcare databases is maturing at a time when regulatory overhaul increasingly demands such evidence. Governance, regulations, and data quality are catching up as the utility of this resource is demonstrated in multiple contexts.

Biomarkers are an important tool in modern drug development. The FDA has posited that increased use of biomarkers in clinical trials can accelerate pharmaceutical industry productivity, ushering new drugs to market. Accordingly, the FDA has created two pathways for evaluation of biomarker utility. Biomarkers incorporated into clinical trials, the traditional pathway, are effectively private to a therapeutic sponsor and to the scope of the trial. By contrast, in Biomarker Qualification (“BQ”), the second pathway, a biomarker is certified as a publicly available tool. The FDA has hoped that academic, non-profit, and industry stakeholders would work together in consortia to qualify biomarkers, cumulatively generating a common resource of broad utility. In practice, utilization of Biomarker Qualification has been paltry. Incentives for BQ that align with the interests of industry resource holders are necessary to fuel increased utilization of biomarkers in clinical trials and create the communal biomarker toolkit envisioned by the FDA. A blanket extension of exclusivity for any drug successfully paired with a companion biomarker would diminish public access to medicine by encouraging spurious biomarkers and correspondingly narrowed clinical trials. As a measured alternative, an exclusive right to include a qualified companion biomarker on an FDA drug label would balance public access externalities. This exclusivity would waylay label approval, and thus marketability, of later drugs relying on the qualified biomarker for clinical safety or efficacy. Accordingly, sponsors would find no incentive to portage an ineffective or unnecessary biomarker through clinical trials, as there would be no benefit to securing exclusive rights in a tool others saw no value in using.

The 21st Century Cures Act encourages the Food and Drug Administration to consider “real-world evidence” in its regulation of the safety and efficacy of drugs and devices. Many have interpreted this mandate to focus on non-randomized observational research. However, we suggest that regulatory science must also move from rarefied academic hospitals to community-based settings, where the vast majority of patients in fact receive care in the fragmented U.S. healthcare system. This move is especially important if innovations are to reach, and be validated in, more diverse populations. A solution can be found in the 183 Practiced-Based Research Networks (“PBRN”), i.e., groups of primary care clinicians and practices in all 50 states working to improve clinical care and translate research findings into practice. This symposium contribution seeks to (1) describe some of the common shortcomings of clinical trials, (2) explore the opportunities and challenges posed by use of real-world evidence as a basis for drug and device regulation, (3) briefly describe the history and evolution of PBRNs, and (4) articulate the challenges and opportunities for using PBRNs to fulfill the 21st Century Cures Act mandate for real-world evidence.