As part of a series examining the first year of the Biden presidency, Harvard Law Today asked two experts in health care law and policy, I. Glenn Cohen ’03, James A. Attwood and Leslie Williams Professor of Law; and Carmel Shachar J.D./M.P.H. ’10, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, to share their thoughts on the administration’s successes, failures, and agenda for the future.
Harvard Law Today: What has the administration done right so far?
Glenn Cohen and Carmel Shachar: Vaccines are by far our best tool at combatting COVID-19, keeping people out of overwhelmed hospitals, and preventing deaths. Improving our vaccination rates is one of the most important public health interventions the administration could do. At the start of the Biden administration the challenge was meeting the demand for COVID-19 vaccines. Later in 2021, the administration correctly recognized that there was a need to push the vaccine hesitant to get their vaccinations and responded by implementing a series of vaccine mandates. These mandates included requiring all health care workers at facilities that participate in Medicare and Medicaid programs to be fully vaccinated and implementing vaccine or test mandates for employers with over 100 employees through the Occupational Safety and Health Administration (OSHA). For example, many organizations such as Tyson Foods saw their vaccination rates jump from around 50% to over 90% in response to the OSHA mandate.
At the same time, the mandates specifically have created a beachhead of political opposition and one that has been able to rhetorically lay claim to libertarian statements about control of one’s body. It may also lead to an unfavorable decision in the U.S. Supreme Court with broader implications for administrative law.
One other positive development is the way the administration has taken more seriously its moral obligations to ensure vaccine access outside the U.S. with increased donation of vaccines. This is definitely a step in the right direction. On the other hand, the administration has been critiqued for not doing enough in terms of forced sharing of intellectual property and enabling the production of Moderna and Pfizer vaccines by entities other than the companies, especially in the developing world.
HLT: What has it gotten wrong?
Cohen and Shachar: Antigen rapid tests are broadly available in Europe and the UK. For example, in the UK these tests are free and you can pick them up in libraries, pharmacies, or order them directly from a government website. Elsewhere in Europe they cost around the equivalent of $1. While these tests aren’t perfect, they can be useful in picking up when people are infectious. And they work best when they are so cheap and plentiful that taking a test is only one degree above brushing your teeth.
By contrast, antigen tests are expensive and relatively hard to find in the United States. This holiday season in particular saw people scrambling to find them before attending family gatherings and holiday parties or returning to school and work. The Biden administration has been working on this problem and we should see many more antigen tests available in 2022. There were many factors that contributed to the current scarcity of antigen tests. First, we have been relatively slow to approve antigen tests in the US as compared to some European countries. Second, over the summer we focused on vaccinations over testing, since vaccinated people were thought to be unlikely to ever get COVID before Delta and Omicron. This meant that the administration failed to pre-purchase antigen tests or to create incentives to produce them in significant numbers. Lastly, we did not anticipate the tsunami of infections brought about by Omicron and how our PCR testing infrastructure would get overwhelmed. Some of these oversights are understandable and some we should have worked earlier to address.
Overall, we need to rethink whether we approach antigen tests as a medical diagnostic or as a public health tool and regulate accordingly. And we need to think through when there might be other situations that would call for speedier regulatory approvals of public health products.
More generally, it feels like the administration has had a major communication problem, including times when the White House and the CDC have been out of step. I think historians of the pandemic will look at the abrupt May 2021 statements by CDC Director [Rochelle] Walensky telling the public it was safe to go unmasked if unvaccinated as a major problem point for what followed. It was an echo of the infamous George W. Bush 2003 “Mission Accomplished” moment, but worse since the public’s actions have been much more important in COVID-19 precaution compliance. Communications like these that are then slowly clawed back rightly confuse people and sap their trust in public health leadership. To be clear the fault lies not in the failure to foresee the exact shape of Delta or Omicron to come, but a repeated tendency in the communication to gloss over the realities of scientific uncertainty inherent in a pandemic in favor of being able to depict a decisive turning point. Another problematic communication moment was when the White House got ahead of FDA on boosters in August 2021. The desire for the administration to be decisive, to tell America “we have got this,” was completely understandable, but the reports that FDA was not there yet gave fuel to some of the more skeptical voices on vaccination.
HLT: What has the administration not addressed yet that it should?
Cohen and Shachar: Our health care system is under significant pressure. There is obvious pressure from the COVID-19 pandemic. Even “milder” strains such as the Omicron variant put thousands of people in hospitals that aren’t built to handle such surges. Even more concerning is the impact that the “great resignation” has had on our health care system, as health care providers respond to significant burn out by leaving the bedside for other opportunities. Massachusetts, for example, lost approximately 500 medical/surgical and ICU hospital beds since the start of the pandemic, due largely to staffing shortages such as nurses quitting or taking other positions. At a time when we need to be adding capacity we are losing capacity in our health care system.
The Biden administration needs to find a way to address this problem. Governors of New Hampshire, Maine, Massachusetts, and Indiana have called upon the National Guard to provide help with nonmedical functions. The Biden administration has also proposed to mobilize military troops and the Federal Emergency Management Agency to help with this problem. This is a good immediate response but ultimately we need more trained providers in our hospitals to truly increase capacity. The Biden administration should think long term about the security of our health care system: how can they incentivize people to enter health care professions such as nursing? What labor protections, such as national patient staffing ratios, need to be put in place to keep these trained professionals at the bedside? The Affordable Care Act put certain obligations on health care insurers, such as imposing target medical loss ratios, to make sure business practices were not undermining national health. It may be time to think about regulations that would build in surge capacity on the provider side to minimize the times in which there simply aren’t ICU or hospital beds available for those who need them.
Omicron also presses the reality that we are likely moving from a COVID-19 pandemic to endemic. The tools needed are different for each. The Biden administration and Congress should be in high gear right now thinking about what programs and funding are needed to manage the endemic. And while we all have pandemic fatigue, there is no reason to think COVID-19 will be the last novel pandemic we face in our lifetimes. There is a tendency to fund public health well during emergencies, then let it languish in between such that when the next pandemic hits we are playing catch up. If we knew a new COVID-level event was likely to happen in, say, eight years’ time, what could we accomplish between now and then? Beyond funding, I think we need to take a step back and examine whether CDC as an institution has the powers and organizational structure it needs, how it relates to FDA and the White House, and more generally how our public health response balances federal and state responsibilities. As to these latter points, the diffusion of responsibility between these governments seems like it has been an Achilles’ heel of effective response, but I am also skeptical that there will be much appetite to really change things.
One last piece of the “looking ahead:” while health policy folks have always known how big the racial gap is in access to health care in this country, the pandemic illustrated it in a way that became unmistakable to all of us. It would be great to see the administration use COVID-19 as a pivot point to address the problem of racial disparities in health care more generally.
HLT: What are the biggest challenges the administration faces to its agenda going forward?
Cohen and Shachar: The Biden administration is facing significant legal challenges to its test-or-vaccinate mandates. Already there has been a lot of movement in the lower courts regarding whether these mandates are lawful. For example, the U.S. Court of Appeals for the Fifth Circuit put the OSHA mandate on hold in November but then the U.S. Court of Appeals for the Sixth Circuit reinstated the mandate in December. Similarly, courts are split as to whether the stricter health care worker mandate is permissible.
At the time of writing, the Supreme Court was about to hear oral arguments relating to the legality of both the health care worker and the OSHA vaccination mandates. Until now there has been a general consensus among public health legal experts that the federal government has the power to implement more targeted mandates. However, it is far from a sure bet that the U.S. Supreme Court will agree — especially given the attitudes of some of the justices to the delegation of power to administrative agencies more generally. If the Biden administration loses these cases it will have to scramble to find a way to encourage further vaccinations and boosters.
Read the series Weighing President Biden’s first year