Person filling syringe from vial.

The Beginning of the End of Federalism As We Know It Here on Earth One and Earth 616?

By Jennifer Bard

Friday’s emergency hearing by the Supreme Court regarding the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate was extraordinary both in that it happened at all and what took place.

The hearing came in a response to a petition by a coalition of states and the National Federation of Independent Business (NFIB) to halt an Emergency Temporary Standard (ETS) issued by OSHA mandating that all employers with over 100 employees “establish minimum vaccination standards” including “vaccination verification, face covering, and testing requirements.”

That the Court heard the case on an emergency basis signaled their concern that OSHA, in issuing the ETS, was overreaching its authority, as they ruled the Centers for Disease Control and Prevention had done in issuing an eviction moratorium.

But what made the colloquies particularly unsettling is that the ETS was carefully crafted to be, as Professors Larry Gostin and Dorit Rubinstein Reiss explain lucidly, well within contemporary standards for an exercise of federal power affecting a health matter usually within the jurisdiction of a state. It applies only to employers already obligated to follow OSHA workplace standards and fell far short of a vaccine mandate. Moreover, however severe the risk of COVID when this was drafted six months ago, the risk from the Omicron variant is many times greater.

Yet the sympathetic ear given by the majority of the Justices to the arguments made by the lawyers seeking a stay made it possible to wonder if the whole thing was happening in either one of DC or the MCU’s multiverse. This is because the questioning, directly and by implication, calls into doubt what past Courts have identified as the framework of federalism — a nickname for the Constitution’s balancing of a strong federal government against the rights of individual states. We cannot know the extent to which the Justices will adopt any of the arguments offered them for limiting federal agency power, but from this hearing we can anticipate substantial strengthening of an individual state’s ability to resist federal regulation.

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U.S. Supreme Court

Major Questions about Vaccine Mandates, the Supreme Court, and the Major Questions Doctrine

By Wendy Parmet and Dorit Reiss

This Friday, the Supreme Court will hear arguments about two federal vaccine mandates: the Centers for Medicare and Medicaid Services’ (CMS) mandate for health care workers, and the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate for employers with over 100 workers. In each case, a key question will be whether the Court should apply the so-called “major questions doctrine.” The Court’s adoption of this approach in the mandate cases would not only remove an important tool for combating the pandemic; it also would severely limit the federal government’s capacity to address many other health threats, while expanding the Court’s ability to substitute its judgment for Congress’.

Although not fully defined or delineated, the major questions doctrine bars administrative agencies from using broad grants of statutory authorities in new and “major” ways. A type of clear statement rule, it requires courts to presume that in the absence of specific Congressional authorization, agencies lack the power to issue new regulations that could be seen as “major.”

In theory, the rule allows courts to avoid federalism and separation of powers concerns. In practice, it empowers courts to resurrect long-discarded approaches to federalism and separation of powers without saying so. It also enables courts to disregard explicit grants of statutory authority (so much for textualism!).

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Picture of north star in starry night sky.

Health Justice as the Lodestar of Incremental Health Reform

By Elizabeth McCuskey

Health justice is the lodestar we need for the next generation of health reform. It centers justice as the destination for health care regulation and supplies the conceptual framework for assessing our progress toward it. It does so by judging health reforms on their equitable distribution of the burdens and benefits of investments in the health care system, and their abilities to improve public health and to empower subordinated individuals and communities. Refocusing health reform on a health justice gestalt has greater urgency than ever, given the scale of injustice in our health care system and its tragic, unignorable consequences during the coronavirus pandemic.

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Los Angeles, California / USA - May 1, 2020: People in front of Los Angeles’ City Hall protest the state’s COVID-19 stay at home orders in a “Fully Open California” protest.

Social Distancing, Social Protest, and the Social Constitution of a New Body of Law

By Lindsay F. Wiley

COVID-19 mitigation orders, court decisions adjudicating challenges to them, and legislation adopted to constrain similar orders in the future are constituting a new body of law governing social distancing.

The emerging law of social distancing is vital to the future of public health. It also offers more general lessons about how law interacts with individual behavior, social norms, and social contestation of what we owe each other as members of a community.

Social protests — including massive protests for racial justice and against police violence as well as much smaller anti-lockdown protests — are playing an important role in these developments.

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President Joe Biden and Vice President Kamala Harris.

6 Actions the Federal Government Should Take in Response to the Delta Variant

By Jennifer S. Bard

Today, the U.S. Centers for Disease Control and Prevention took an important step in protecting the nation’s health by reinstating indoor masking for both vaccinated and unvaccinated alike, in particularly high-risk circumstances. That’s good. And so is the jump in institutions like the Veterans Health Administration requiring COVID-19 vaccination.

But we need to take more forceful action, and it needs to happen faster.

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The White House, Washington, DC.

What Can the Federal Government Do When States Make Dangerous Decisions?

By Jennifer S. Bard

The threat posed to the welfare, economy, and security of the United States by the rapidly spreading COVID-19 virus is as serious as any we have ever confronted.

But, at the same time that the federal government is spending billions of dollars on distributing vaccines, and exerting their authority by prohibiting evictions and requiring masks on public transportation, many individual states are not just refusing to take effective measures to stop the spread, but also are pouring gasoline on the fire by doing all they can to undermine even the remaining, weak guidelines published by the CDC. Some have gone so far as to restrict the flow of information by prohibiting public health officials from disseminating news about the vaccines provided by the federal government.

The effects of these actions not only promote the spread of COVID-19, but also fuel its mutation into new forms, and cannot be confined by any existing geographic or cartographic boundary. So how is the federal government allowing this to happen? It’s not for lack of authority.

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Washington, DC, USA - Closeup view of December, 23, 2020: COVID-19 Vaccination Record Card by CDC on blurred documents background.

Key Considerations for the Ethical Design of COVID-19 Vaccine Passports

By Chloe Reichel

States, employers, retailers, and other industries are now grappling with how to update mask policies in light of recent CDC guidance, which suggests vaccinated individuals may remove their face coverings indoors. 

But without a system in place to discern who has been vaccinated, the guidance poses a major risk: unvaccinated individuals, who can still contract and spread the virus, may also opt to go maskless. 

COVID-19 digital health passes, often called vaccine passports, may prove useful as a tool to relax mask policies. Vaccine passports can help to verify whether individuals may safely enter a space without a face covering.

Their ethical implementation, however, is contingent upon a number of factors: first and foremost, equitable access to vaccines. Other considerations include minimizing distrust, accessibility, risks of discrimination, and privacy protections.

For policy makers considering the implementation of COVID-19 vaccine credentialing programs, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Edmond J. Safra Center for Ethics at Harvard University have developed a road map highlighting key considerations for their ethical design.

This post provides a summary of key considerations and responsive policy recommendations presented in the paper to guide more equitable implementation of vaccine passports and to minimize distrust.

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Map of the United States.

Health Reform via State Waiver

By Erin Fuse Brown and Chelsea Campbell

The path to systemic health reform in the U.S. may run through the states. To get there, the Biden/Harris administration should use its existing waiver authority under federal health care statutes to facilitate progressive state health reform efforts, including a state-based public option or single-payer plan.

One of the benefits of the United States’ federalist system, in which the power to enact policy and govern is divided between the national government and the states, is that we can test policies at the state level, and if we can establish a proof of concept there, it smooths the way for federal reform.

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Key Takeaways from Petrie-Flom Center Discussion on Vaccine Passports

As mask mandates fall to the wayside, COVID-19 digital health passes, often called vaccine passports, hold promise as a tool to verify whether individuals may enter a space without a face covering.

Vaccine passports, however, also pose a number of ethical and legal challenges. Panelists discussed these concerns during an April 28 webinar hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics titled, “Vaccine Passports: A Path to the New Normal?”

This article highlights key points made during the conversation.

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Hand arranging wood block pyramid with health icons on each block.

ERISA Preemption Reform: Unlocking States’ Capacity for Incremental Reform

By Elizabeth McCuskey

For the past 46 years, the Employee Retirement Income Security Act (ERISA) has preempted state regulation that “relates to” employer-sponsored health benefits. 

Much has changed in health care and society over that time; but ERISA’s preemption abides — widely maligned, yet unaltered. An ERISA preemption waiver thus presents a long-overdue update to health care regulation with a lot to recommend it to the Biden Administration’s health care agenda: it enables states to “strengthen and build on the Affordable Care Act,” it offers a modest incremental step that could pave the way for bigger structural change, it prompts no federal spending, and it has bipartisan political support. 

The preemption provision in 1974 was supposed to entice multistate employers to offer benefits by creating some federal uniformity in benefit regulation. For health benefits, however, that uniformity has been largely deregulatory.

ERISA preemption currently prevents states from fully enforcing a wide variety of health reforms, ranging from claims data collection to state-level employer mandates. And it casts a pall of private litigation challenges over even the ones that should be enforceable, like surprise billing regulation, prescription drug pricing measures, and state and local public option plans.  

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