By Ross D. Silverman and Gabriel T. Bosslet
Most entities requiring vaccination mandates or proof of vaccination upon entry may offer limited grounds upon which an individual may request an exemption, usually based upon religious beliefs or medical reasons. Recent history with childhood immunization programs shows less rigorously-structured and -enforced vaccination exemption policies are vulnerable to increased usage, relative to narrower or more stringently-monitored programs. That history also shows there is a possibility some health care licensees may be willing to support individuals seeking to circumvent COVID-19-related requirements through offering questionable medical exemptions.
Entities imposing COVID-19 vaccination mandates, and state health care licensure boards, can take several simple but significant steps to counter misuse of medical exemptions and better protect communities from COVID-19. These safeguards also can decrease the temptation for licensed health professionals to recklessly undermine critical, lawful, evidence-driven public health efforts.
Medical Exemptions and SARS-CoV-2 Vaccine Contraindications
Vaccination mandates generally include a process through which individuals may request a medical exemption based on concerns that the vaccine itself may pose a particularly significant health risk.
Under federal law, individuals who work in an environment where a vaccine is mandated may request a reasonable accommodation that would exempt them from the vaccination requirement due to having a disability that places them at such a risk. The process for a medical exemption is dependent on the policies of the institution requiring vaccination; but for most, the procedure includes the employee submitting an affidavit supported by a statement by a licensed health care provider that outlines the medical reason for the exemption.
This process may be vulnerable to abuse. For example, efforts by families to circumvent childhood school vaccination mandates have led some physicians to violate practice standards in how they write medical exemptions. Several California physicians have been disciplined by the California medical board for such practices, including one San Diego, California-area physician who was placed in 2020 on three years’ probation for writing over 1,000 medical exemptions for families seeking to avoid the state’s school vaccine requirements.
Likewise, some health care licensees may be willing to support COVID-19-related medical exemptions to vaccination mandates based on specious or nonexistent grounds.
Already, we have seen during the pandemic willingness among some licensed health care providers not only to spread questionable COVID-related information, but also to fulfill requests to circumvent COVID-related prevention measures. For example, the California Medical Board recently sent notice to its licensees raising concern about some physicians’ conduct related to writing mask mandate exemptions. Licensees have also been prosecuted by the Federal government for falsifying proof of vaccination documents.
Currently there are very few absolute contraindications to SARS-CoV-2 vaccination (listed in Table 1). In an ideal world, medical exemptions would be limited to absolute contraindications.
Table 1- Contraindications to COVID-19 vaccination
|Absolute contraindications||Conditions that necessitate a vaccine precaution (not a contraindication- 30 minute post-vaccine observation period)|
|Severe immediate allergic reaction to a previous dose of the COVID-19 vaccine||History of an immediate allergic reaction to any other vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies|
|Previous allergic reaction to Polyethylene Glycol (PEG)|
|Previous allergic reaction to Polysorbate|
However, given that the vaccines are new and currently authorized by the U.S. Food and Drug Administration under emergency use authorizations, there remain those who will pursue medical exemptions for reasons outside of the absolute contraindications to the vaccine. Most institutions require a clinician to attest to the medical reason for the contraindication.
Bolstering Exemption Request Review
West Virginia and California have implemented policies and practices to minimize the misuse of medical exemptions in their childhood immunization programs that, if widely adopted, could also reduce the likelihood that licensed health professionals will participate in fraudulent, unethical, or reckless behavior associated with COVID-19 medical exemption applications.
In West Virginia, all medical exemption requests must be written by a licensed care provider that has treated or examined the patient. The application must include specifics about the medical contraindication or diagnostic precaution that supports the request. The state Immunization Officer — a clinician employed by the state health department — then must review and approve the exemption application. All employers implementing mandates could adopt policies incorporating the first two practices, and larger entities, such as universities, government systems, and health systems, would be well positioned to include a robust internal clinical review process as part of the exemption application process.
After California changed its school and daycare vaccination policy, restricting exemptions only to those based on medical grounds, the state saw a significant rise in the number of submitted medical exemptions. Complaints submitted by school district health staff and others alerted the state medical board to a cohort of licensed practitioners regularly submitting exemption affidavits. One physician submitted as many as 1,000 over a four-year period.
The Medical Board of California recognized participation in medical affidavit writing as the practice of medicine, and responded by taking disciplinary action against “exemption mill” providers and those deviating from practice standards when offering medical affidavits. State licensing and disciplinary boards for physicians, physician assistants, and nurses could announce and adopt a similar stance regarding the provision of COVID-19 vaccination exemptions.
Further, entities implementing vaccination mandates could help monitor these clinical practices by collecting records of the licensees who contribute to their employees’ exemption and accommodation requests, and registering complaints with the appropriate licensing board for providers engaging in seemingly inordinate or unfounded exemption affidavit filings.
Through state licensure, the public entrusts health care providers with special privileges and duties of care to patients and to the protection of the public’s health. Health care professionals continue to be among the first and most trusted sources for science-informed guidance and behavior in this pandemic.
While individuals with genuine medical contraindications to vaccination must be afforded the opportunity to pursue reasonable accommodations from such mandates, licensed health professionals should be expected to uphold the ethics and clinical standards of their professions when examining and assessing medical exemption applicants. By declaring the participation in COVID-19 and other vaccine medical exemption writing as a clinical practice subject to review and discipline, state licensing boards can play a critical role in protecting the public’s health and preventing their licensees from facilitating the specious undermining of standards of clinical practice and public health protection.
Table 2 – Recommendations to minimize medical exemption misuse
|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
|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.
Ross D. Silverman, JD, MPH is Professor of Health Policy and Management at the Indiana University Richard M. Fairbanks School of Public Health and Professor of Public Health and Law at the Indiana University McKinney School of Law.
Gabriel T. Bosslet, MD, MA is Associate Professor of Clinical Medicine in the Department of Pulmonary, Critical Care, Sleep and Occupational Medicine at Indiana University and an affiliate faculty member at the Charles Warren Fairbanks Center for Medical Ethics.