Questionable Medical Exemptions for Vaccines Up After New Law

A California law designed to increase vaccination rates among schoolchildren by eliminating nonmedical exemptions is turning out to be a source of considerable frustration among state health officers and immunization staff, researchers report in an article published online October 29 in Pediatrics.

Those interviewed for the study say one of the biggest problems is the lack of authority to override questionable medical exemptions written by physicians who engage in unprofessional or even unethical behavior in providing them, explain Salini Mohanty, DrPH, MPH, of the Department of Family and Community Health, the University of Pennsylvania School of Nursing, Philadelphia, and colleagues. They warn that without aggressive legal challenges, some of these physicians may continue to write unwarranted exemptions, and in so doing, limit the law's efficacy.

Also, Mohanty and colleagues note, the law requires that all medical exemptions be submitted directly to the child's school for review, which places a burden on the school and has already resulted in at least one lawsuit.

Overall, the law, known as Senate Bill 277 (SB277), has been a success: since its implementation in 2016, the proportion of kindergarten students who received all required vaccines rose from 92.8% in 2015-2016 to 95.1% in 2017-2018, and the rates of personal belief exemptions (PBEs) have declined steadily since the 2013-2014 school year.

However, these promising outcomes have been tempered by a concomitant increase in medical exemptions, especially in counties that previously had high rates of PBEs. "Counties that had high PBE rates before SB277 also had the largest increases in medical exemptions during the first year of SB277 implementation, leaving portions of California susceptible to vaccine-preventable outbreaks," they write.

A Model for Other States

Because it is a large and diverse state, California could serve as a model for other states whose governments may be considering adopting similar legislation, the authors explain. They explain that their objective in conducting the study "was to describe the experiences of local health jurisdictions while addressing medical exemption requests under SB277."

To that end, Mohanty and colleagues conducted semistructured telephone interviews with members of the Health Officers Association of California, which represents health officers in 58 counties and three cities across the state. The final analysis consisted of 34 detailed interviews conducted with 40 participants representing 35 of the 61 local health jurisdictions in California. One participant represented two jurisdictions. Interviewees included 18 health officers, seven communicable disease coordinators, nine immunization coordinators or directors, and six public health nurses.

Major Themes Emerge

From the interviews, the authors identified four major themes: the role of stakeholders; review of medical exemptions received by the schools; problematic medical exemptions; and concerns and frustrations related to those exemptions.

Stakeholders included physicians, schools, and the California Medical Board, as well as state and local health departments, the authors explain. Physicians have the authority and discretion to confirm the reason for an ME and to write the exemption, which would then be sent to the schools.

The health departments were expected to support the schools in their review of the exemptions, but they have "no authority to question the scientific validity of the medical exemptions according to California law. Many participants wanted the California Medical Board to take a more active role in disciplining physicians who were writing medical exemptions that they perceived to be problematic," the authors write.

Schools varied in their policies regarding the exemptions. In some schools, all exemptions were followed up; in other schools, only specific cases were examined. One of the jurisdictions that routinely tracked all exemptions was named in a federal lawsuit, along with the Department of Health, the Department of Education, and several local health jurisdictions, that was filed by a group of parents and nonprofit organizations.

The suit, which was ultimately withdrawn, is often cited as a reason why some jurisdictions no longer track all medical exemptions. One interviewee reported receiving hate mail and death threats because of that tracking policy.

Most of the participants reported few or no medical exemptions that seemed questionable, but there were some striking exceptions, such as the following:

One listed every criterion for exemption named in SB277, including a family history of adverse effects to vaccines, such as "autoimmune disorders, inflammatory bowel disease, allergic disorders, neurologic problems, neurodevelopmental disorders, [and] psychiatric disorders," and requested "temporary exemptions" through 2030.
Some exemptions were issued by a physician who worked at a medical marijuana dispensary.
A high volume of exemptions was written by a physician who charged patients $300 and required them to watch a video on vaccine safety before they received the exemption. The exemptions expired after 3 months, forcing patients to return and pay for another exemption.
Some physicians advertised online that they would provide medical exemptions for a fee.

The authors warn that the paucity of questionable exemptions does not necessarily mean that such exemptions were, in fact, rare. Rather, because most of the jurisdictions do not routinely track the exemptions, the participants most likely saw only "the most egregious examples."

Among the biggest frustrations and concerns listed by the interviewees was the lack of authority to enforce any penalties against physicians perceived to be writing questionable exemptions and the undue burden SB277 places on school staff to implement the law. They also expressed concern that "medical exemptions could be used as a substitute for PBEs," which "would limit the intended impact of SB277 in preserving and protecting herd immunity."

In general, SB277 has been "a great success, with sharp increases in vaccination rates seen in kindergartners entering school," Richard J. Pan, MD, MPH, and Dorit Rubinstein Reiss, LLB, PhD, write in an invited commentary about the study. The rise in medical exemptions was not unanticipated, since PBEs had been used for some children who would also have qualified for medical exemptions. But after implementation of the law, the number of medical exemptions "more than tripled, with some schools reporting ME [medical exemption] rates >20%, revealing that many students received inappropriate MEs."

The granting of unwarranted exemptions should be considered unprofessional behavior that could be subject to liability or discipline by the state licensing board, write Pan, a state senator, and Reiss, a professor at Hastings College of the Law at the University of California, San Francisco. However, several obstacles, including a lack of cooperation by patients' families, who often desire the unwarranted exemptions, make these cases difficult to pursue.

At the very least, they conclude, "[p]ublic health officers should have the authority to invalidate unwarranted MEs and revoke the delegation of authority to grant MEs from physicians who abuse it." They also urge pediatricians to work with public health advocates and "proscience parents" to enact legislation "that empowers public health officers to protect our children and community."

Study limitations include potential recall bias on the part of the participants and the fact that participation in the study was voluntary and may have attracted interviewees with particularly strong views on the subject.

The study was funded by the National Institutes of Health. One of the study authors has previously received consulting and/or research support from Merck, Pfizer, and Walgreens. The other study authors have disclosed no relevant financial relationships. Dr Reiss's family owns regular stock in GlaxoSmithKline. Dr Pan is an elected official; he has has disclosed no relevant financial relationships.

Pediatrics. Published online October 29, 2018. Full text, Commentary