Most off-label uses of prescription drugs are not supported by strong clinical evidence, leading to millions of patients being exposed to poorly understood risks without well-established benefits. The FDA’s approach to limiting these risks has been to bar manufacturers from promoting their drugs for off-label uses. But this strategy has had only limited success and is threatened by courts’ increasing willingness to extend First Amendment protections to drug makers’ speech. This Article proposes that the FDA should shift its focus from off-label promotion toward off-label prescribing. The Agency should provide information on drug labels about the strength of the evidence that supports common off-label drug uses. Leveraging the FDA’s unique ability to gather and analyze information and physicians’ role as learned intermediaries could alter prescriber practices to reduce the rate of unsupported off-label drug uses.
North Carolina Medicaid covers one-fifth of the state’s population and makes up approximately one-third of the budget. Yet the state has experienced increasing costs and worsening health outcomes over the past decade, while socioeconomic disparities persist among communities. In this article, the authors explore the factors that influence these trends and provide a series of policy lessons to inform the state’s current reform efforts following the recent approval of North Carolina’s Section 1115 waiver by the Centers for Medicare and Medicaid Services. The authors used health, social, and financial data from the state Department of Health and Human Services, the Robert Wood Johnson Foundation, and the University of North Carolina to identify the highest cost counties in North Carolina. They found higher per beneficiary spending to be inversely related to population health, with many counties with the most expensive beneficiaries also reporting poor health outcomes. These trends appear to be attributed to a breakdown in access to basic health services, with high cost counties often lacking adequate numbers of health care providers and possessing limited health care services, leading patients to primarily engage the health care system in a reactive manner and predominantly in institutional care settings. To illustrate this pattern, the authors developed case studies of Tyrrell County and Graham County, which respectively are home to the state’s worst health outcomes and most expensive Medicaid beneficiaries. The authors combined stories of these counties with the larger historical trends to offer policy recommendations to help reorient North Carolina Medicaid around patient needs. The results shed light on traditionally understudied hotspots of cost and poor outcomes in North Carolina, while proposing tangible steps to support reform.
Over the last three decades, there has been a steady movement to increase access to aging in place as the preferred long-term care option across the country. Medicaid has largely led this effort through expansion of state waivers that provide Home and Community-Based Services (HCBS) as an alternative to nursing home care. HCBS include the provision of basic health services, personal care, and assistance with household tasks. At the time of this writing, seven states have explicitly tailored their waivers to support aging in place by offering HCBS solely for older adults, individuals aged 65 and over. However, there is growing concern about aging in place contributing to greater risk for social isolation, and with that increased exposure to elder abuse. Abuse, neglect, and unmet need are highly visible in an institutional setting and can be largely invisible in the home without preventative measures to safeguard against maltreatment. This article examines the seven states with Medicaid HCBS waivers that target older adults, over a 36-year period, starting with the first state in 1982 to 2018. We conducted qualitative analysis with each waiver to explore the presence of safeguards that address risk factors associated with elder abuse. We found three broad categories in caregiver selection, quality assurance, and the complaints process where there are notable variations. Drawing on these findings, we outline features where Medicaid HCBS waivers have the potential to mitigate risk of elder abuse to further support successful aging in place.
Advancements in genetic technology have resurrected long discarded conceptualizations of “race” as a biological reality. The rise of modern biological race thinking – as evidenced in health disparity research, personal genomics, DNA criminal forensics, and bio-databanking - not only is scientifically unsound but portends the future normalization of racial inequality. This Article articulates a constitutional theory of shared humanity, rooted in the substantive due process doctrine and Ninth Amendment, to counter the socio-legal acceptance of modern genetic racial differentiation. It argues that state actions that rely on biological racial distinctions undermine the essential personhood of individuals subjected to such taxonomies, thus violating a protected privacy interest in avoiding race-based biological classifications by the government. The ascendance of modern de jure genetic racial classifications has received only minimal attention thus far in the literature, with prominent scholars such as Dorothy Roberts addressing the socio-political roots of the phenomenon. This Article contributes to the discussion by further developing a constitutional framework by which to challenge state-sanctioned biological racial taxonomies.
Medical legal partnerships (MLPs) respond to the medicalization of poverty by addressing the legal and social problems that cause or contribute to poor health. MLPs achieve their mission through collaboration among health care, legal, and public health professionals. Those MLPs with a highly integrated team of professionals offer more comprehensive, coordinated assistance to patient-clients. The success of this interdisciplinary team model depends on open communication among the various MLP professionals. Unfortunately, legal, ethical, and practical barriers often prevent MLP professionals from sharing patient-client information with one another. This Article identifies these barriers and explains how they may undermine the effectiveness of MLPs by hindering data sharing and integration among MLP professionals.
Biologics, the most effective medications used to treat chronic debilitating autoimmune diseases such as Rheumatoid Arthritis, are also the most expensive, even for those with top shelf insurance. Biosimilars, which replicate biologics through the use of similar living organism extracts, will impact biologics’ American sales — biosimilars are generally much cheaper than biologics. Legal scrutiny in the biologic/biosimilar arena has focused on the Amgen versus Sandoz litigation, market share, and the biosimilar FDA approval process, established through the Biologic Price Competition and Innovation Act. Less coverage has been devoted to state-level battles over biosimilars. States have considered how biosimilars should be named, even though there is FDA guidance on the issue. Many state laws impose patient and physician consent requirements on insurance companies or pharmacists that seek to substitute biosimilars for biologics, even though the FDA does not require any additional action once an interchangeable biosimilar is exchanged for a biologic. This essay will consider whether state laws are impeding biosimilar market access, addressing how the laws have been marketed as “patient-friendly” legislation. Finally, it will propose how to involve patients at the state legislative level so that patient needs are heard and met.
Most of the legal commentary regarding mobile health has focused on direct regulation leveraging existing laws and regulators such as HIPAA privacy through HHS-OCR or device regulation by the FDA. However, much of the mobile health revolution likely will play out in lightly regulated spaces bereft of most of the privacy, security, and safety rules associated with traditional health care. This article examines the potential for common law liability models to bridge these gaps (even on a temporary basis). Part II of this paper provides an introduction to the terminology used, and presents a brief typology of the apps appearing in the health care space. Part III discusses the potential liability of physicians and other health care professionals. Part IV discusses the potential liability of institutional health care providers such as hospitals (that, in many cases is dependent upon the finding of fault in an individual professional). Part V discusses the applicability of product liability to mobile health developers and vendors. Part VI explains some of the issues that may arise when patients or consumers seek damages following privacy or security breaches. The survey concludes by noting that regulation by litigation may be a significant force in the app and wearable space during a period of light regulation by traditional regulators. This is a conclusion that is unlikely to cheer either health care providers or app developers; given that the indeterminacy associated with common law litigation is only exacerbated when applied to novel or emerging technologies.
