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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Passport in suitcase.

Ethical, Legal, and Scientific Challenges for COVID-19 Vaccine Passports

By Chloe Reichel

As COVID-19 vaccines become more widespread, passports that certify immunization status may facilitate a return to normalcy, write Lawrence O. Gostin, I. Glenn Cohen, and Jana Shaw in a viewpoint published today in JAMA.

But these vaccine passports, or digital health passes, are not without scientific, legal, and ethical challenges.

I asked Gostin, Faculty Director of the O’Neill Institute for National and Global Health Law at Georgetown University Law Center, Cohen, Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and Shaw, a professor of pediatrics at Upstate Medical University, about the key areas of concern and promise for vaccine passports. Our conversation, which has been edited and condensed, follows.

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Madison, Wisconsin / USA - April 24th, 2020: Nurses at Reopen Wisconsin Protesting against the protesters protesting safer at home order rally holding signs telling people to go home.

The Consequences of Public Health Law Vacuums

By Daniel Goldberg

Pandemic planning documents and materials from the early 2000s to the present anticipated a great deal of what the U.S. has been experiencing during the COVID-19 pandemic. The best of such plans documented exactly what be required to manage, respond, and control a pandemic spread by a highly communicable respiratory virus like SARS-CoV-2.

What the plans did not account for was what we are now experiencing: That governments would simply refuse to govern.

Few truly accounted for the possibility that the very entities charged with regulating for the health, safety, and welfare of their residents and citizens would simply decline to do so, choosing instead the public health law vacuums in which we find ourselves at the present time. Read More

Police cars.

The False Promise of City-Wide Psilocybin Decriminalization

By Kathryn Lucido

While city-wide decriminalization of psilocybin is a positive step toward decreasing the impact of the war on drugs, it also creates a false sense of security and progress.

Citing new research that illustrates the therapeutic promise of the drug, several U.S. cities have decriminalized psilocybin, a psychedelic compound that occurs naturally in some fungi. Though these cities have pledged not to spend resources prosecuting people for psilocybin possession, and, in some cases, limited distribution, the substance remains illegal at the federal, state, and city levels.

Psilocybin remains a Schedule I drug under the Controlled Substances Act. This classification means that — at least according to Congress and the Drug Enforcement Administration — psilocybin is a dangerous drug with no currently accepted medical uses and a high risk for abuse.

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Block Grants: Sound Theory or Doomed to Fail?

Block grants are all the rage. Take the latest G.O.P. proposal to repeal and replace the Affordable Care Act: the Graham-Cassidy bill. It proposes to replace the current system and instead give grants to the states, essentially taking the funds the federal government now spends under the ACA for premium subsidies and Medicaid expansion and give those funds to the states as a lump sum with little regulation.

There is a complicated formula by which the bill proposes divvying up this money among the states. Many think the formula is unfair, that it benefits red states over blue states, and that it just flat isn’t enough money. These are incredibly important concerns. But let’s put them to the side for just a moment and consider the theory behind block granting. Is there any world, for instance assuming that the amount and allocation of the funding could be resolved (probably crazy talk), in which switching to block granting may actually improve upon the status quo?

Proponents of block granting health care make two main arguments. First, it will reduce costs. By block granting Medicaid and the ACA subsidies, we end the blank check open entitlement that these programs have become and give states more skin in the game. Second, these cost savings will come from empowering states to innovate. States will become more efficient, improve quality, and solve their own state-specific problems.

These arguments have an understandable appeal. But how will states really react to providing health care coverage on a budget? Read More

President Trump’s Tort Reform

By Alex Stein

President Trump’s budget for Fiscal Year 2018 proposes a thoroughgoing reform of our medical malpractice system [Executive Office of the President of the United States, Major Savings and Reforms, Budget of the U.S. Government, Fiscal Year 2018, at 114 (2017) (hereinafter, the “Budget”)]. The reform’s stated goals are “[to] reduce defensive medicine … limit liability, reduce provider burden, promote evidence-based practices, and strengthen the physician-patient relationship.”

To achieve these goals, the reform will introduce the following measures:

  • a cap on non-economic damage awards of $250,000 (adjustable to inflation);
  • a three-year statute of limitations;
  • allowing courts to modify attorney’s fee arrangements;
  • abolition of the “collateral source” rule (to allow judges and jurors to hear evidence of the plaintiff’s income from other sources such as workers’ compensation and insurance);
  • creating a safe harbor for clinicians who follow evidence-based clinical-practice guidelines.

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