Monthly Review: COVID-19 Legal and Ethics Issues – September 13, 2021

Monthly Review: COVID-19 Legal and Ethics Issues – September 13, 2021

Biden Administration Vaccine Mandate Plan

Nearly 10 months after the rollout of the first Covid-19 vaccines, the United States remains mired in a nearly uncontrolled pandemic. Nationwide, infection rates are ten times higher than what are needed to contain the spread of the virus, and hospitals and health systems in many states, including Indiana, are rationing health care services to address the latest wave of Covid-19-related hospitalizations. 

Vaccinations have become readily available in nearly every community in the U.S. A recent Centers for Disease Control and Prevention study confirms how effective vaccination is against even the more easily spread Delta variant — those who are fully vaccinated are five times less likely to become infected, more than ten times less likely to be hospitalized, and more than ten times less likely to die from Covid-19 than those who are not fully vaccinated.  

While 175 million Americans are now fully vaccinated, eighty million eligible adults remain unvaccinated, and vaccination for the nation’s children under 12 is still not a (legal) option for at least a few more weeks.

Because of the risks that continued, largely unchecked viral spread through our communities poses on the nation’s health, safety, and economy, President Biden on September 9 announced a new six-part plan to bolster adult vaccination rates. Many of the details of the plan have yet to be made public, however, the information that has been released allows us to offer some preliminary analysis, and also has resulted in some vigorous criticism and opposition.

Many critics have raised individual choice and individual liberty concerns related to the Biden plan. However, there is a reason that, in the wake of the announcement, the 1905 Supreme Court case Jacobson v. Massachusetts became a top trending topic on Twitter. In that decision, which upheld the city of Cambridge, Massachusetts’ law requiring that Henning Jacobson either get vaccinated against the smallpox or pay a fine, Justice Harlan wrote the following in the majority decision:

“But the liberty secured by the Constitution of the United States to every person within its jurisdiction does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint. There are manifold restraints to which every person is necessarily subject for the common good. On any other basis, organized society could not exist with safety to its members. Society based on the rule that each one is a law unto himself would soon be confronted with disorder and anarchy. Real liberty for all could not exist under the operation of a principle which recognizes the right of each individual person to use his own, whether in respect of his person or his property, regardless of the injury that may be done to others.”

Notable passages in the Biden plan announcement include:

  1. The Department of Labor’s Occupational Safety and Health Administration (OSHA) will will issue a new regulation (first as an Emergency Temporary Standard) requiring that private sector employers with 100+ employees put in place a requirement that their employees either be vaccinated or “or require any workers who remain unvaccinated to produce a negative test result on at least a weekly basis.” While the language of the regulation has not yet been released, the “to produce” language implies that it won’t be the employer’s obligation to offer the tests, increasing the admin burden for those who remain unvaccinated.
  2. Because taking time off to get vaccinations (or to recover from potential vaccination side effects) remains a barrier for some workers, another OSHA rule will require that employers with 100+ employees provide paid time off for workers to get vaccinated and/or take off time for post-vaccination effects. This builds upon the optional ARP tax credit program employers could sign up for that ran out this month.
  3. Instead of requiring federal workers submit some form of attestation to vaccination, this policy will require Federal employees be vaccinated. This requirement also will be extended to contractors doing business with the federal government.
  4. Expanding on the requirement released earlier this summer that nursing home employees be vaccinated, this new initiative will require vaccination of health care workers in “most” settings that receive Medicare or Medicaid reimbursement (hospitals, dialysis facilities, ambulatory surgeries, home health).

One critique of the proposal is that it may not go far enough to influence uptake of vaccination by the most vulnerable populations in the U.S. workforce who remain unvaccinated. According to Justin Feldman, a Harvard University FXB Fellow of Health and Human Rights, as many as 50 million private sector workers, including half of Hispanic private sector workers, will not be covered by the OSHA policies due to their excluding companies with under 100 workers. And focusing on using OSHA policy to increase vaccination may leave out other opportunities that agency and state employment safety offices have to improve workplace safety for our most vulnerable populations

I also have found useful this essay examining and critiquing the proposed OSHA vaccination mandate, as well as the likely legal challenges that policy will face.

Vaccine Mandate Structure

It will be important to examine and keep in mind the details of what is being “required” under the Biden plan. A mandate is not the same thing as compelling vaccination (forced vaccination). In most settings, vaccine mandates are (a) being connected to privileges to be or act in a particular way in particular settings; and (b) come with alternatives that would allow the individual to make choices other than to receive the vaccination. As described above, the Biden vaccine mandate is to either get a vaccination or, if you choose not to be vaccinated, be tested weekly. While vaccination would offer stronger community protections, the testing requirement, while making for a “softer” mandate, does still offer some protections to the health and safety of both the individual worker and to the workforce more generally. 

Furthermore, it is likely the employer will have the choice of either implementing the policy or facing the possibility of paying a fine. As leading public health law and employment law scholars Lindsay Wiley and Sam Bagenstos discuss in their Arizona State Law Journal article “The Personal Responsibility Pandemic” (see pp. 1272), the size of whatever fines might be levied may not be high enough to drive nearly universal compliance with the new rule (especially for large companies who may write off having to pay such fines as a business cost), and reductions in funding for the oversight agency (OSHA) over the last several decades has led to there being too few inspectors to adequately investigate and prosecute scofflaws. As Wiley and Bagenstos conclude, “Resistance to workplace safety regulation has long rested on the notion that it is up to individual workers to decide whether to avoid risky jobs. That resistance has led to the persistent underfunding of OSHA and the agency’s many delays in issuing standards. Both at the level of doctrine and at the level of politics, then, the fault/responsibility paradigm has constrained occupational safety and health law in a way that makes it unlikely to protect workers who are particularly vulnerable to COVID-19.”

Vaccine Exemptions

Most vaccination policies also offer exemptions to their mandates, largely based on religious or medical grounds. We have already seen waves of Covid-19-related vaccination exemption requests filed on religious grounds, and some exemptions also are being filed based on having medical conditions that contraindicate vaccination. Exemptions based on questionable religious grounds are much more likely to be filed than those submitted based on fraudulent medical evidence. This is because, as legal scholar Dorit Reiss notes, religious exemptions are very hard to police, and very easy to game.

While the New York Times notes, “Major religious traditions, denominations and institutions are essentially unanimous in their support of the vaccines against Covid-19,” vaccination resistors and anti-vaccination groups have made it extremely easy to find information on how to craft passable exemption requests for most policies. Furthermore, as I’ve been writing about for nearly 20 years, legally, it is impermissible for those overseeing religious exemption requests to reject them based on whether or not it is possible to connect those beliefs to specific religious doctrine. Instead, those reviewing religious exemption requests are limited to only assessing whether the religious beliefs are “sincerely held” by the exemption applicant. Consequently, while it may be possible to conduct investigations into the individual’s past behaviors to see if they have acted consistently (e.g., do they have a history of similarly declining or seeking exemptions for flu vaccines?), implementing such an approach is costly and timely, and rejections are likely to bring with them legal challenges. 

Although religious exemptions are an easier path toward opting out of vaccine mandates, as Intensive Care physician Gabriel Bosslet and I wrote recently in a piece titled “Preventing Misuse of Covid-19 Vaccine Medical Exemptions” for the Harvard Petrie-Flom Center’s Bill of Health blog, now would be a good time for every state health licensing board to announce that engaging in Covid vaccination-related medical exemption writing (the exams & the affidavits) constitutes health care practice subject to review, and for employers to consider if they’ll accept exemptions from telehealth consults. We believe the increase in implementation of vaccine mandates and passports will increase interest in such exceptions, and that some licensees may be willing to fulfill patient requests.

A number of state licensing boards, and the Federation of State Medical Boards, have already taken steps to declare that those holding state licenses to practice health care professions who share false or misleading Covid-related information online will be considered to be violating standards of practice and potentially subject to discipline by the state. In our piece, we outline several steps we believe state medical boards and employers should take, including:

For entities mandating vaccines:

  • Limit range of acceptable medical exemption statement writers to active, licensed health care providers (such as MDs, DOs, NPs, PAs) who have treated and/or examined the individual
  • Require the inclusion of the clinician’s state license number as part of the exemption statement
  • Collect information on clinician exemption writers and periodically review whether certain licensees have made an unexpected number of exemption statements for separate individuals
  • State that information collected by the institution, and that those found frequently to contribute exemption statements may be reported to the state licensing board out of concern for the health and safety of the individual and the entity
  • Indicate that grounds for medical exemptions must be connected to contraindications as expressed by the Centers for Disease Control, the vaccine manufacturer, and/or the individual’s physical condition contraindicating immunization

For state licensing and disciplinary boards:

  • Send announcement to licensees raising their awareness of the concern of medical exemption misuse, and restating that evaluations, record keeping, and completion of medical exemption statements constitute professional practice subject to professional clinical and ethical standards, and are therefore subject to potential review by the board
  • Alert businesses, higher education institutions, and other entities with vaccination mandates that the board is interested in hearing reports related to improper or frequent exemption writing
  • Commit to investigating and prosecuting practitioners for vaccine exemption-related practices, including frequent service as an exemption statement writer.

Finally, with regard to alternate approaches to motivating vaccine uptake: Delta Airlines recently instituted a policy that, instead of mandating vaccination, would require that unvaccinated employees pay $200 more per month for their health insurance costs. In the two weeks since adopting that policy, 20% of the company’s unvaccinated employees have gotten vaccinated.

More Vaccine Mandate News

The school district for Los Angeles County, the nation’s second largest school system, has implemented a Covid-19 vaccination mandate for all students aged 12 and over.

|2021-09-13T08:05:53-04:00September 13th, 2021|COVID-19 Literature|0 Comments

About the Author: Ross Silverman

Ross Silverman
Ross D. Silverman, JD, MPH, is Professor of Health Policy and Management at Indiana University Fairbanks School of Public Health and Professor of Public Health and Law at Indiana University McKinney School of Law in Indianapolis. He is a member of the IU Centers on Health Policy and Bioethics. His research focuses on public health and medical law, policy, and ethics, and law's impact on health outcomes and vulnerable populations. He also serves as Associate Editor on Legal Epidemiology for Public Health Reports, the official journal of the Office of the U.S. Surgeon General and the U.S. Public Health Service. His most recent Covid-19 publications include: "Ensuring Uptake of Vaccines Against SARS-CoV-2" in the New England Journal of Medicine (with MM Mello & SB Omer), and "Covid-19: control measures must be equitable and inclusive" in BMJ (with ZD Berger, NG Evans & AL Phelan)

Get Involved with Indiana CTSI