white pills spilling out of orange plastic pill bottle onto hundred dollar bills.

Merck Price Negotiation Lawsuit May Face Same Obstacles as 340B Takings Claims

By Laura Dolbow

Merck recently filed a lawsuit that challenges the constitutionality of the Medicare price negotiation program created by the Inflation Reduction Act. Under this program, HHS will select a small number of single source drugs for price negotiation. Merck alleges that the price negotiation program operates as a price control because it effectively requires manufacturers to accept the maximum fair price as a condition of participation in Medicare and Medicaid. Merck argues that this form of price regulation charts a “radical new course” for Medicare that violates the Takings Clause of the Fifth Amendment.

But the price negotiation program is not the first time that Congress has placed a restriction on the prices that Medicare program participants can charge. And Merck’s lawsuit is not the first suit that has alleged that such price regulations are unconstitutional takings. Drug manufacturers recently made similar claims in litigation involving the 340B Drug Pricing Program. Two district courts rejected those claims, highlighting several obstacles that Merck’s takings claim may face as well.

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Emergency room.

Hospitals That Ditch Masks Risk Exposure

By Nina Kohn and Irina D. Manta

This month, New York became the latest to join the growing list of states that have ended their requirements for routine masking in hospitals and other healthcare settings.

In response, at least one of the state’s largest hospital systems is throwing off the mask despite the continued high level of virus transmission in New York City and most of the rest of the state. NYU’s Langone hospital system decided that — outside of the Emergency Room — patients would generally only be required to mask “if they have fever and cough” (query what percentage of individuals with recent COVID-19 infections did not have this specific combo of symptoms — spoiler: it’s probably high). Similarly, the hospital announced that masking by direct care staff was optional in most situations, with masks required mainly during certain procedures, in particular patient rooms, or — more cryptically — when “there is concern for exposure to infectious aerosols.”

Ending routine masking in hospital settings is a dangerous move. It puts patients and staff at risk for infection, and its potential long-term effects. It also exposes hospitals to the risk of liability.

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handmade wooden chess board, two pawns face off.

FTC’s Proposed Non-Compete Rule: A Step in the Right Direction for Health Care and Biotechnology

By Aparajita Lath

In January, the Federal Trade Commission (FTC) released a new draft rule that would categorically ban non-compete clauses — contractual terms between an employer and an employee that prevent subsequent employment at a competing firm — across the country.

Banning non-compete clauses may help to promote competition and innovation in biotechnology and health care.

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Nov 22, 2019 Palo Alto / CA / USA - Close up of Amazon logo and Smile symbol at one of their corporate offices located in Silicon Valley, San Francisco bay area.

One Medical Acquisition: The Path Forward

This piece has been adapted slightly from its original form, which was published at On the Flying Bridge on July 24, 2022.

By Michael Greeley

Last week’s $3.9 billion acquisition of One Medical (NASDAQ: ONEM) by Amazon triggered significant hyperventilating about the transformative and immediate impact of this transaction on the health care industry. Interestingly, Amazon’s market capitalization increased 1.4% or $18.3 billion on the day of the announcement, paying for the purchase a few times over. Undoubtedly there could be exciting near-term benefits for the 750,000 ONEM members as their Amazon Prime accounts are linked to their ONEM memberships, facilitating targeted Whole Food and Amazon Pharmacy coupons. But what we might expect to see over time is a provocative debate with powerful implications for how each of us manage the arc of our health care journeys.
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Empty nurses station in a hospital.

The AMA Can Help Fix the Health Care Shortages it Helped Create

By Leah Pierson

Recently, Derek Thompson pointed out in the Atlantic that the U.S. has adopted myriad policies that limit the supply of doctors despite the fact that there aren’t enough. And the maldistribution of physicians — with far too few pursuing primary care or working in rural areas — is arguably an even bigger problem.

The American Medical Association (AMA) bears substantial responsibility for the policies that led to physician shortages. Twenty years ago, the AMA lobbied for reducing the number of medical schools, capping federal funding for residencies, and cutting a quarter of all residency positions. Promoting these policies was a mistake, but an understandable one: the AMA believed an influential report that warned of an impending physician surplus. To its credit, in recent years, the AMA has largely reversed course. For instance, in 2019, the AMA urged Congress to remove the very caps on Medicare-funded residency slots it helped create.

But the AMA has held out in one important respect. It continues to lobby intensely against allowing other clinicians to perform tasks traditionally performed by physicians, commonly called “scope of practice” laws. Indeed, in 2020 and 2021, the AMA touted more advocacy efforts related to scope of practice that it did for any other issue — including COVID-19.

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Field hospital in NY during COVID-19 pandemic.

Systemic Failures Need Systemic Solutions: COVID-19 and Macromedical Regulation

By Barak D. Richman and Steven L. Schwarcz

Among the many failures to mitigate the harm from COVID-19 in the U.S. has been the failure to meet surging demand for inpatient care. Hospital bed shortages, overwhelmed intensive care nurses, and scarcities of needed medical equipment have been embarrassing but constant features of the American health care landscape. A nation that spends nearly one out of every six dollars on health care should get much, much more for its money.

Though there is much blame to go around — and many insightful commentators have already allocated culpability — we observe that a significant regulatory deficiency has contributed to the nation’s failure to meet population health needs. This is the failure to regulate our hospitals holistically, as part of a comprehensive health care system.

Existing health care regulation focuses almost exclusively on regulating individual components of the health care industry. This existing regulation lacks the capacity to address how those components work together as a system — a system in which deficiencies in one component adversely impact the performance of the other components. We should not view hospitals as individual providers that treat individual patients. Instead, they are part of a larger safety net that needs to expand capacity when emergencies arise. Today’s pandemic destabilized hospital care because hospitals were neither coordinated nor managed systemically in order to meet population demands.

In Macromedical Regulation, 82 Ohio State Law Journal 727 (2021), we address the nation’s systemic failure to contain an infectious contagion, and we offer solutions by deriving lessons from the 2008 financial contagion. We contend that health care regulation must also include what we call “macromedical” regulation: regulation that focuses on protecting the stability of the health care sector as a system of interconnected parts.

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Senior citizen woman in wheelchair in a nursing home.

The Barriers to Aging in Place

By Renu Thomas and John Roth

The COVID-19 pandemic has highlighted the risks associated with institutionalized care for the elderly, and has further shifted sentiments toward a preference for aging in place. But most seniors and their loved ones don’t realize the barriers that make aging in place a difficult proposition until a crisis occurs and they’re faced with finding services.

Take our family, for example. My father was diagnosed with Parkinson’s disease and it was after his first fall and discharge from the hospital that our family realized my parents’ independence was severely limited. We knew their house was not wheelchair or walker accessible, but we also needed to address other issues as well; neither of them could drive anymore, so how would we get them to appointments, how would their prescriptions and groceries get picked up, and how could we prevent them from being socially isolated? Like many families, we do not live nearby, let alone in the same state, which made coordinating these services even more challenging.

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Empty Classroom In Elementary School With Whiteboard And Desks.

Addressing School Discipline Disparities Through the Health Justice Framework

By Alexis Etow and Thalia González*

As an interdisciplinary legal scholar and public health attorney studying how education policies fit into the broader antiracist health equity agenda, health justice serves as both a conceptual framework for reform for legal academics and an accessible roadmap for change for policymakers and public health law professionals. Health justice functions to extend what has been previously accepted as within the health domain beyond traditional health care settings, systems, or laws. This broad applicability leaves ripe the opportunity to employ it to a broad range of health-impacting laws, policies, and systems that may not be designed or previously conceptualized as public health.

Consider, for example, school discipline and policing. Researchers and advocates have long-documented the disparate punishment and policing of Black, Indigenous, people of color (BIPOC) students compared to their white peers. For students with disabilities, especially those with intersectional identities, the risk factors and impacts of such policies are amplified. In the case of Black girls with disabilities, data shows that they experience the highest disparity for rates of referrals to law enforcement: six times more than white, non-disabled female students.

During COVID-19 and school closures, the disproportionality of these practices not only persist, but schools now employ new models of exclusion and police practices. This includes students remaining in Zoom waiting rooms during instructional time, resulting in unexcused absences, learning loss, and eventually truancy prosecution.

Despite evidence of the significant co-influential nature of health and education and specific health-harming effects of school discipline and policing — e.g., negative effect on students’ mental health, diminished health protective factors, disrupted educational attainment, threat to safety and wellbeing, and increased risk for justice system involvement — public health has been largely underemphasized in reform efforts and overlooked by the health law community. This is where a health justice approach is critical: it knits together and affirms that health and public health law professionals have key roles to play in education policy, law, and practice. It also places the health-harming effects of school discipline and policing squarely in the domain of public health law and prioritizes legal and policy responses with health equity at the forefront.

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U.S. Capitol Building.

Congress Should Act to Fund Medical-Legal Partnerships

By Emily Rock and James Bhandary-Alexander

On August 9, legislators introduced a new bill in Congress that allocates funding to the development of Medical-Legal Partnerships (MLPs), in recognition of the important role MLPs can play in the lives of older Americans.

As attorneys with the Medical-Legal Partnership program at the Solomon Center for Health Law and Policy at Yale Law School, we strongly encourage Congress to act quickly to pass this legislation.

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