a crowd of people shuffling through a sidewalk

What Makes a Bad Public Health Decision? And How Can We Make Good Ones?

By Jennifer S. Bard

What makes a bad public health decision?

What we’ve seen across both the Trump and Biden administrations is that relying on the CDC’s medical model of decision-making isn’t working. No matter how sound the underlying science or medicine, public health guidance cannot be effective if its target audiences don’t understand it and it’s impossible to deploy.

The recent U.S. Centers for Disease Control and Prevention (CDC) guidance suggesting that people who are vaccinated do not have to wear masks is an instructive example.

Reporters over the past few days have confirmed that this decision was made inside the CDC, by its director, without any notice to, let alone consultation of, the state and local health authorities, retailers, and schools that would have to implement it.

But the job of public health demands an approach that encompasses such groups. Unlike medical doctors (and practicing attorneys) who bear fiduciary duties to individual patients, public health professionals’ obligations are not to individuals, but to populations. And fulfilling these obligations is very hard. It’s one thing to tailor an intervention or craft an explanation for the person in front of you, and quite another to do the same for a community.

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A pile of three surgical masks.

Public Health Law vs. Individual Advice: Why Discarding Indoor Mask Mandates Is a Mistake

By Jennifer S. Bard

The U.S. Centers for Disease Control and Prevention (CDC) announced today that fully vaccinated individuals no longer need to wear masks indoors or outdoors in most cases.

The agency has emphasized that this is merely guidance, and is not intended to affect public policy or to change practices of private companies. But it is naïve to imagine that health departments and private organizations will not make changes in response to the announcement.

There is a growing public wish to put COVID-19 behind us by eliminating visible signs that it still exists (e.g., mask wearing). But guidance driven by this magical thinking will cause unnecessary harm. Public health measures should protect the larger population, including those who cannot be or have not yet been vaccinated. This CDC guidance proffers individual advice at the expense of the goals of public health.

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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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U.S. Capitol Building at Night

A Legislative Override Could Save the ACA (and Fix Other Misapplications of Health Laws)

By John Aloysius Cogan, Jr.

The Congressional Democrats and the Biden administration need not wait for the Supreme Court to determine the fate of the Affordable Care Act (ACA) in California v. Texas; they can take charge of the case today by enacting and signing into law overriding legislation. 

Since the threat to the ACA is based on the interpretation of a federal statute — the ACA’s “inseverability clause” — Congress is within its rights to take charge of the case. Why? Because courts are not the final word on the meaning of a statute, Congress is.

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Symposium Introduction: Recommendations for a Biden/Harris Health Policy Agenda

By Erin C. Fuse Brown

This digital symposium explores recommendations for the Biden/Harris administration’s health policy agenda. We asked leading health law scholars to describe one health policy action the administration should pursue, beyond the pandemic response. Their recommendations make up this symposium. The responses range from concrete policy changes to broad reform ideas and can be grouped into three categories, those that (1) Reverse and Restore; (2) Reinforce; (3) Reform.

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U.S. Capitol Building at Night

Advantages of Using the Congressional Review Act to Revoke Health Care Waivers

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.

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Waitress wears face mask and face shield, cleans table with alcohol and wet wipe at restaurant.

The Problem with Individual-Level Interventions to Curb the COVID-19 Pandemic

By Daniel Goldberg

The failure to control the COVID-19 pandemic in the United States rests, in part, on the individualist nature of our public health responses.

Public health simply does not work well when we base our interventions on the individual level. This is known as “methodological individualism,” and the evidence suggests it is both ineffective and can expand existing health inequalities. It is problematic in any public health context, but especially in pandemic response and control.

Take, for example, the ongoing debate over mask mandates. Multiple governors have refused to issue mask mandates, instead simply requesting that people don masks. The objection, interestingly, is not to the idea of masking as a public health intervention, but to the existence of a mandate itself.

Yet a model of public health which consists of nothing more than pleading with individuals to avoid behaving in ways injurious to public health would be an abject failure. Imagine if, instead of imposing minimum requirements for clean water, we simply asked regulated industries to avoid polluting watersheds. Or perhaps instead of passing laws discouraging or even criminalizing obviously harmful behavior, we simply asked people to avoid driving drunk.

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Highway alert: Covid-19 checkpoint ahead, overhead sign in Florida on state border.

Amending the Public Health Service Act to Encourage CDC Action to Stop COVID-19

By Jennifer S. Bard

The U.S. Centers for Disease Control and Prevention (CDC) already has all the power it needs to limit the movement of people in order to slow the spread of COVID-19.

Yet, throughout this pandemic, they have taken no steps beyond issuing stark warnings, which have been only marginally effective. For example, this Thanksgiving, estimates indicate that almost 5 million flew and up to 50 million drove to join others. Dr. Deborah Birx is warning that everyone who did so should consider themselves infected.

The CDC’s historic reluctance to institute the politically unpopular measure of restricting travel could be countered by adding a self-executing amendment to 42 U.S. Code 264 requiring that the option be assessed at the beginning of an outbreak and periodically reviewed. More specifically, this amendment should create a review committee and set metrics for travel restrictions.

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a stethoscope tied around a dollar bill, with a bottle of pills nearby

Can We Expect Legislation on Surprise Medical Billing? I’d Be Surprised

By Abe Sutton

Surprise medical billing has emerged as a top political priority amid a torrent of complaints about expensive balance billing.

Despite leaders such as President Trump, former Vice President Biden, and members of the 116th Congress pledging to address surprise medical billing, federal legislation is unlikely, due to powerful health associations’ divergent interests. To shake legislation loose, the President would need to publicly take a side and expend political capital on a creative solution.

In this piece, I walk through why federal legislative action has been stymied to date, and what it would take to get surprise medical billing legislation over the line.

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Is FDA’s 2013 Budget At Risk?

By Patrick O’Leary

Back in February, President Obama’s FY 2013 budget authorized $4.5 billion for the Food and Drug Administration (FDA), about $2 billion of which was to come from user fees, the fees paid by regulated industry under a variety of schemes including the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee Act (MDUFA) and newly-created programs for generic drugs and biosimilars. As of today, FDA’s ability to collect and use these fees is in question, endangering vital agency activities including drug and device premarket review.

The threat to FDA user fees crystallized on September 14, when the Office of Management and Budget released its Report Pursuant to the Sequestration Transparency Act of 2012, explaining what may happen if Congress fails to reach an accord on the federal budget as required by the Budget Control Act of 2011 (BCA). Such a failure would trigger sequestration resulting in an 8.2% reduction in non-exempt, non-defense discretionary funding. On pages 79-80, the report indicates that $3.873 billion of FDA’s budget for 2013 is considered eligible for sequestration. According to analysis by the Alliance For a Stronger FDA, this indicates that major user fee programs have been included as sequestration-eligible funds. According to the OMB report, the FDA budget would be reduced under sequestration by around $318 million.

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