Hundred dollar bills rolled up in a pill bottle

Aducanumab: A Bitter Pill to Swallow

By Emily Largent

On June 7, the U.S. Food and Drug Administration (FDA) used the Accelerated Approval pathway to approve aducanumab, which will go by the brand name Aduhelm, to treat patients with Alzheimer’s disease (AD). Aducanumab, developed by Biogen, is the first novel therapy approved for AD since 2003. This news has left many experts stunned.

I have at least one colleague, Dr. Jason Karlawish, who has publicly stated that he will not prescribe aducanumab. Other clinicians have said they will only prescribe it reluctantly. These are individuals who have dedicated decades of their lives to treating patients with AD, to conducting path-breaking research and serving as investigators in clinical trials, and to advocating for public policies that will better serve AD patients and their families. Many have also seen their own families affected by AD. My colleagues are hardly indifferent to the suffering wrought by AD and would like to have a meaningful treatment to offer to patients and their families. But, they have concluded, aducanumab is not it.

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United States Capitol Building - Washington, DC.

Congress Should Insulate the Indian Health Service from the Next Government Shutdown

By Matthew B. Lawrence

Contributors to Bill of Health’s symposium on Recommendations for a Biden/Harris Health Policy Agenda have made a number of excellent suggestions. I have one more policy suggestion to add and endorse: Congress should adopt the Biden Administration’s recent proposal to insulate the Indian Health Service from future government shutdowns.

A service population of 2.5 million American Indians and Alaska Natives rely on the federally-funded Indian Health Service (IHS). The IHS is one of several trust obligations that the U.S. government owes Native peoples as a result “of Native Americans ceding over 400 million acres of tribal land to the United States pursuant to promises and agreements that included providing health care services,” as the U.S. Commission on Civil Rights put it.

Yet the IHS is dependent entirely on annual one-year appropriations from Congress. That means that the House and the Senate must come together, on time, every single year on an appropriations package, for the IHS to continue all its operations.

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Person in nursing home.

Long-Term Care After COVID: A Roadmap for Law Reform

By Nina A. Kohn

Between May 2020 and January 2021, 94 percent of U.S. nursing homes experienced at least one COVID-19 outbreak. And nursing home residents — isolated from family and friends, dependent on staff often tasked with providing care to far more residents than feasible, and sometimes crowded into rooms with three or more people — succumbed the virus at record rates. By March 2021, nursing home residents accounted for a quarter of all U.S. COVID-19-related deaths.

The poor conditions in nursing homes that have been exposed by the pandemic are symptomatic of long-standing problems in the industry.

Fortunately, as I discuss in-depth in a new essay in the Georgetown Law Journal Online, there are a series of practical reforms that could readily improve the quality of nursing home care, in large part by changing the incentives for nursing home providers.

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WASHINGTON, DC - OCT. 8, 2019: Rally for LGBTQ rights outside Supreme Court as Justices hear oral arguments in three cases dealing with discrimination in the workplace because of sexual orientation.

The Many Harms of State Bills Blocking Youth Access to Gender-Affirming Care

By Chloe Reichel

State legislation blocking trans youth from accessing gender-affirming care puts kids at risk, thwarts physician autonomy, and potentially violates a number of federal laws, write Jack L. Turban, Katherine L. Kraschel, and I. Glenn Cohen in a viewpoint published today in JAMA.

So far this year, 15 states have proposed bills that would limit access to gender-affirming care. One of these bills, Arkansas’ HB1570/SB347, already has become law.

This legislative trend should be troubling to all, explained Cohen, Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. In an email interview, he highlighted “how exceptionally restrictive these proposed laws are,” adding that they are “out of step with usual medical, ethical, and legal rules regarding discretion of the medical profession and space for parental decision-making.”

Turban, child and adolescent psychiatry fellow at Stanford University School of Medicine also offered further insight as to the medical and legal concerns these bills raise over email.

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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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Reston, USA - April 9, 2020: Social distancing sign at cashier check-out aisle inside Trader Joe's grocery shop store during coronavirus with woman employee in mask.

Passing the Buck: What the CDC Guidance on Masks Gets Wrong About Public Health

By Carmel Shachar

As Americans shed their masks in response to recent U.S. Centers for Disease Control and Prevention (CDC) guidance, the most vulnerable among us face an unfair choice: either to enforce public health hygiene or forgo being in public spaces entirely.

The new guidance, which states that fully vaccinated people can resume activities without wearing masks or socially distancing, is too nuanced for a country in which a significant percentage of adults continue to refuse vaccination and there are no mechanisms to enforce masking or social distancing for the unvaccinated.

Ultimately, this shift in policy unfairly burdens small businesses and individuals to be the guardians of public health, when it should be our community leaders responsible for enforcing public health norms.

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Herndon, USA - April 27, 2020: Virginia Fairfax County building exterior sign entrance to Mom's Organic Market store with request to wear face mask due to covid-19 pandemic.

Are Employers That Ditch Mask Mandates Liable for COVID-19 Infections at Work?

By Chloe Reichel

Last week, in response to U.S. Centers for Disease Control and Prevention (CDC) guidance indicating that vaccinated individuals need not wear face coverings indoors, a number of states and businesses swiftly did away with indoor mask mandates.

Widespread criticism followed, focusing on the dangerous policy vacuum that now exists. The CDC has suggested unvaccinated individuals follow an honor system and continue masking — but such an honor system is difficult, if not impossible, to enforce.

In the absence of indoor mask policies, individuals face increased risk of exposure to the virus. And some groups are particularly at risk of contracting the virus now, including immunocompromised individuals, for whom vaccines may not confer protection, and children under the age of 12, for whom a vaccine has not yet been authorized.

To better understand the new guidance and its implications for workers who are no longer protected by mask mandates, I spoke with Sharona Hoffman, an expert in health and employment law. Hoffman is the Edgar A. Hahn Professor of Law, a professor of bioethics, and Co-Director of Law-Medicine Center at Case Western Reserve University School of Law. In our interview, Hoffman explained whether an employer may be held liable if an employee contracts COVID-19 after an occupational exposure, and highlighted other key issues to anticipate regarding COVID-19 and the workplace.

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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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Grafton, Illinois, USA, June 1, 2019 -Car submerged under flood water in small river town, Grafton, Illinois, as Mississippi River floods roads, businesses and houses. vehicle under water, men in boat

Bail Out Humans

By Christina S. Ho

This past year has sensitized us politically to government’s affirmative obligations, especially the duty to backstop health catastrophes in order to dampen the risks that ordinary people must bear. 

Our government bails out large risks in so many other arenas. Yet we too often fail to backstop the most human risk of all — our vulnerability to suffering and death. 

Throngs of scholars have described our deep tradition of government-sponsored risk mitigation to nurture favored private activities and expectations, and relieve those favored actors from catastrophes beyond what they could be expected to plan for. I have characterized this distinctive political role figuratively as one of “government as reinsurer.”

The federal government provides standard reinsurance for private crop insurers, virtually full risk-assumption for private flood insurance, guarantees for employer pension benefits, robust backstops for bank liquidity risks, FHA mortgage insurance and a federal secondary market to absorb the risks of housing finance.

In these arenas and more, statistically correlated or high-magnitude catastrophic losses are shed onto the state in order to smooth out and shore up the underlying private risk market. We have yet to commit similarly in the health care domain. 

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People protesting with signs that say "healthcare is a human right" and "medicare for all."

A Long View on Health Insurance Reform: The Case for an Employer Public Option

By Allison K. Hoffman

Historically, job-based health insurance coverage was the gold standard. It was broadly available to workers and was comprehensive. It covered the lion’s share of most services someone might need. 

Yet, job-based private health coverage has been in decline. Employers are struggling to maintain plans in the face of escalating health care prices, and indicating the need for government involvement to solve this problem.  

Even before the pandemic, a decreasing share of workers, especially lower wage workers, had health benefits through their jobs. The majority of the currently uninsured are workers, either those whose jobs do not offer them coverage, such as gig workers and part-time workers, or those who are offered coverage but cannot afford their share of the cost. Ironically, some of these workers become ineligible for Affordable Care Act (ACA) marketplace subsidies because they are offered job-based coverage. 

Even for those who have job-based coverage, health benefits have become less generous over time, leaving households vulnerable to unmanageable health care expenses. The average deductible for a worker-only plan has increased 25% over the last five years and 79% over the last ten years. 

To help address these shortcomings and challenges of job-based coverage, the Biden administration should offer employers a Medicare-based public health insurance option for their employee coverage. It would simultaneously offer an out for employers who want it, and start to build the foundation for a simpler, more equitable financing system down the road.

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