The complex regulatory framework governing the U.S. health care system can be an obstacle to programming that address health-related social needs. In particular, health care fraud and abuse law is a pernicious barrier as health care organizations may minimize or forego programming altogether out of real and perceived concern for compliance. And because health care organizations have varying resources to navigate and resolve compliance concerns, as well as different levels of risk tolerance, fears related to the legal landscape may further entrench inequities in access to meaningful programs that improve health outcomes. This article uses food and nutrition programming as a case study to explore the complexities presented by this area of law and to highlight pathways forward.

The US Food and Drug Administration’s controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer’s disease, has motivated multiple policy reforms. Drawing a case series of other drugs granted accelerated approval and interviews of senior FDA officials, I argue that reform should be informed but not defined by aducanumab. Rather, structural reforms are needed to reshape FDA’s core priorities and restore the regulatory system’s commitment to scientific rigor.

In “Missing the Forest for the Trees: Aduhelm, Accelerated Approvals & the Agency,” Dr. Matthew Herder argues that agency capture and politicized discretion drive delays in confirmatory trials of accelerated approval drugs amongst other concerns at US Food and Drug Administration (FDA). In highlighting this important problem and offering nuanced insight into agency workings based in part on interviews with twenty-three unnamed FDA officials and a three-drug case study, Dr. Herder suggests two innovative solutions. However, amidst broader debates balancing agency expertise, data, and delegation, these proposed policy solutions would benefit from more corroborative evidence and consideration of institutional advantages within constitutional limits.

Political debate regarding trans youth’s access to gender-affirming care (GAC) has pushed many to advocate for GAC by pointing to tragic, pathological outcomes of non-treatment, namely suicide. However, these pathologized arguments are a harmful ethical “shortcut” which should be replaced by a meaningful engagement with the ethics of providing GAC to youth.

This response to Kariyawasam and Rai affirms their critique of the pathologization of trans youth but forecasts a foreseeable negative outcome of their proposed elimination of diagnosis as a prerequisite to gender-affirming care (GAC) — the risk of removing GAC entirely from the medical sphere and compromising the wellbeing of those transgender individuals for whom GAC is deeply affirming. We suggest an ethical framework of GAC that expands past a focus on autonomy to incorporate a principle of respect for persons that affirms the dignity and diversity of trans youth — recognizing the need to facilitate both medical assistance and social change.

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.

A series of structural constitutional arguments lodged in multiple cases against Centers for Medicare and Medicaid Services’ (CMS) authorities to negotiate prescription drug prices via the 2022 Inflation Reduction Act threaten the legitimacy of CMS program and federal agency powers.

In recent months, pharmaceutical manufacturers have brought legal challenges to a provision of the 2022 Inflation Reduction Act (IRA) empowering the federal government to negotiate the prices Medicare pays for certain prescription medications. One key argument made in these filings is that price negotiation is a “taking” of property and violates the Takings Clause of the US Constitution. Through original case law and health policy analysis, we show that government price negotiation and even price regulation of goods and services, including patented goods, are constitutional under the Takings Clause. Finding that the IRA violates the Takings Clause would radically upend settled constitutional law and jeopardize the US’s most important state and federal health care programs.

The United Nations (UN) General Assembly High-Level Meeting (HLM) on pandemic prevention, preparedness and response (PPPR) was a missed opportunity to bring high-level commitment and momentum to the global governance of health emergencies. Intended to bring much-needed attention to a policy issue that is rapidly slipping down the international agenda, the fraught diplomacy among member states, lack of consensus on key issues, and weak UN Political Declaration in New York foreshadow a difficult road ahead for upcoming negotiations under the World Health Organization (WHO) in Geneva. This column chronicles the evolving engagement of the UN in global health governance, examines the diplomatic process leading to the UN HLM on PPPR, and assesses the contributions and missed opportunities of its resulting Political Declaration.

Our students ought to know about the history of formal hospital segregation and desegregation. To that end, this article urges those who teach foundational health law and policy courses to do three things. First, to teach the Simkins case. Second, to swap out the usual Medicare signing ceremony picture for one that includes W. Montague Cobb, M.D., Ph.D. Third, to highlight how the implementation of that program for the elderly led, in a matter of months, to the desegregation of hospitals throughout the country.

To provide effective care physicians must attend, not just to medical issues, but also to the social determinants of health — racial factors, food insecurity, housing instability, transportation barriers and beyond. Social determinants also include a largely underrecognized dimension: legal vulnerabilities such as rental evictions and debt adjudications. Yet rarely do medical trainees have an opportunity to witness legal vulnerabilities, firsthand.

Developers and vendors of large language models (“LLMs”) — such as ChatGPT, Google Bard, and Microsoft’s Bing at the forefront—can be subject to Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) when they process protected health information (“PHI”) on behalf of the HIPAA covered entities. In doing so, they become business associates or subcontractors of a business associate under HIPAA.