By Lance Gable
At the start of 2023, public health law in the United States faces two obvious structural shortcomings that need to be addressed: the inadequate fit between public health emergency powers and longer-lasting emergencies, and the increased susceptibility of public health law to dilution through political and judicial action.
By Sarah Wetter and Lawrence O. Gostin
In the Federalist No. 78, Alexander Hamilton called judicial independence “the best expedient which can be devised in any government to secure a steady, upright, and impartial administration of the laws.” Judicial independence is also critical for public health. Over the last century, courts have affirmed broad public health powers and established modern health-related rights. Yet in a significant departure from history, today’s federal courts have been far from impartial, issuing ideology-driven decisions that will resound for decades to come, with harmful public health consequences.
By Martha Lincoln
From spring 2020 through the present day, Americans have endured levels of sickness and death that are outliers among not only wealthy democracies, but around the world. No other country has recorded as many total COVID-19 casualties as the United States — indeed, no other country comes close.
This situation is not happenstance. From early moments in 2020, the concept of a right to health — and indeed, even a right to life — has been discounted in American policy, discourse, and practice. Quite mainstream and influential individuals and institutions — physicians, economists, and think tanks — have urged leaders to shed public health protections — particularly masking — and “move away” from the pandemic. Over the past two years in the United States, leaders in both political parties have capitulated to — if not embraced — the doxa that a certain amount of death and suffering is inevitable in our efforts to overcome (or “live with”) the pandemic. In a piece written during the first months of COVID under Trump, I called this dangerous yet influential outlook necrosecurity: “the cultural idea that mass death among less grievable subjects plays an essential role in maintaining social welfare and public order.”
By Cathy Zhang
Open enrollment for the health insurance marketplace begins on November 1.
Among the options available to consumers will be short-term, limited-duration insurance (STLDI), also known as junk insurance plans. The Trump administration facilitated the proliferation of these cheap, underprotective plans in an attempt to undermine the marketplace, and the Biden administration has yet to reverse that policy.
As part of the Biden administration’s public effort “to restore and strengthen Americans’ access to quality, affordable health care,” the administration needs to take executive action to protect consumers and eliminate junk plans.
By John Jacobi
As the Biden administration works to improve health access and transform health delivery, behavioral health reform should be at the front of the queue.
People with severe mental illness and opioid use disorder are dying young for lack of routine health care. Much of the work that needs to be done in behavioral health is developed or developing at the state level. But the Biden administration has a powerful tool for encouraging state-level innovation in the § 1115 Medicaid waiver process.
Section 1115 waiver authority permits the Department of Health and Human Services to approve pilots and demonstrations if they are found likely to promote the objectives of the Medicaid program. Waivers, which do not require Congressional or formal regulatory enactments, permit relatively rapid cycling of innovation, in contrast to the lumbering pace of legislative or regulatory change.
While applications for waivers originate with the states, presidents have set the agenda by signaling what categories of waivers will be looked upon favorably, offering the administration the ability to put its stamp on the development of care for low-income and disabled people.
By Molly Prothero
One of President Biden’s earliest actions in office was to sign an executive order asking Congress and the US Department of Agriculture (USDA) to expand the Supplemental Nutritional Assistance Program (SNAP).
President Biden proposed that Congress extend the 15% SNAP benefit increase, originally passed in late December. Biden’s executive order also directed the USDA to issue new guidance documents enabling states to increase SNAP allotments in emergency situations and update the Thrifty Food Plan, the basis for determining SNAP benefits, to better reflect the cost of a nutritious diet today.
President Biden’s actions stand in sharp contrast to Trump, who sought to limit the reach of SNAP benefits during his time in office. In December 2019, Trump’s USDA issued a final rule restricting SNAP eligibility for unemployed adults without dependents.
By Jacob Howard
In the waning days of the Trump administration, a final push was made to fundamentally weaken regulation of medical devices.
Lambasted as a “full frontal assault on public health” by U.S. Food and Drug Administration (FDA) officials, key policy changes include proposed emergency exemptions to bring a multitude of devices to market without the necessary scientific backing. Justified as a strategy to expedite the delivery of life-saving products, this speed comes at a risk to millions of patients.
As the third most prevalent cause of death in the U.S., medical error continues to be a critical issue that is exacerbated by weakening integrity of the regulatory process. This issue is further compounded by the fact that past regulatory failures in the medical device sphere have not been adequately addressed. The surgical stapler offers an illustrative example.
By Matthew B. Lawrence
The Trump Administration has granted health care waivers that the Biden Administration will surely look to end, including work requirement waivers that the Supreme Court is going to consider in Azar v. Gresham. How the Biden Administration approaches this task may set precedents that last far into the future, which is one argument in favor of considering the Congressional Review Act as a potential path forward.
Waivers are a huge part of health policy. They entail a state seeking approval from the federal government to make various changes to ACA or Medicaid programs. Waivers are normally approved for several years at a time, and routinely renewed. They foster experimentation, and are also (or especially) a tool the federal government uses to steer national health policy by pushing states to adopt some reforms and not others, as I explain in a forthcoming article.
Over at the Yale Journal of Regulation blog, I describe how the Congressional Review Act (CRA) could potentially be used to revoke health care waivers (like community engagement, aka work requirement, waivers).
In brief, the CRA is a way Congress can change the law to revoke agency actions without the votes necessary to override a filibuster. The CRA might be a cleaner alternative for revoking health care waivers than administrative revocation by the Biden Administration. One big policy advantage of this route is that it wouldn’t come back to haunt health policy. Revocations through the administrative process would set a precedent that could undermine the stability of all waivers, but revocations through the CRA would not.
A version of this post first ran in Ms. Magazine on October 28, 2020. It has been adapted slightly for Bill of Health.
By Aziza Ahmed
In recent months, public health guidance from the U.S. Centers for Disease Control and Prevention (CDC) has become a site of political reckoning.
The agency has taken an enormous amount of heat from a range of institutions, including the executive and the public, during the COVID-19 pandemic. The former has sought to intervene in public health guidance to ensure that the CDC presents the President and administration’s response to COVID-19 in a positive light. The latter consists of opposed factions that demand more rigorous guidance, or, its opposite, less stringent advice.
Importantly, these tensions have revealed how communities experience the pandemic differently. CDC guidance has produced divergent consequences, largely depending on demographics. These differences have been particularly pronounced along racial lines.
By Abe Sutton
While the Most Favored Nation (MFN) Interim Final Rule (IFR) advances a well-calibrated policy to standardize pharmaceutical prices across developed nations, procedurally, its issuance was a mistake.
The Trump administration would have been wiser to issue a Notice of Proposed Rulemaking (NPRM) for two reasons: first, an NPRM would have circumvented some of the procedural vulnerabilities of the IFR. And second, had the Trump administration issued an NPRM, President-Elect Biden’s team would have faced significant pressure to finalize the policy.
In this post, I touch on what MFN is, examine why the interim final rule is legally vulnerable, explore why the Biden team likely would have adopted the policy had an NPRM been issued, and explain how industry should think about this situation.