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On 20 June 2019, after a long day of testimony on California SB276 from both sides of the mandatory vaccine issue, the assembly health committee voted 9 in favor, 2 against, and 2 abstaining to move forward with the bill which can prevent fake medical exemptions.

This post will describe the amended bill and then shortly address today’s events.

SB276 details

On 22 May 2019, the California Senate voted in favor of SB276. The bill then passed to the assembly and was assigned to be heard in the Assembly health committee. However, in early June Governor Gavin Newsom expressed concerns about the bill. There followed negotiations between the Governor’s office and the bill’s initiator, Senator Richard Pan, MD, which ended with a substantially amended bill.

I will say now that while SB276 makes concessions, I think overall it is a better, and stronger system, which preserves legitimate medical exemptions and correctly focuses on the doctors writing fake exemptions as the source of the problem, and creates tools to deal with them. And at any rate, the Governor expressed willingness to sign the amended bill – and a signed bill is better than a vetoed one.

In terms of concessions, the main concession of the bill was to remove the ex-ante general review process. In the original version, every medical exemption would have to be reviewed before it is approved. In the new version, a physician would have to submit a copy of the exemption to the department, and the department would create a system to review medical exemptions from schools with less than 95% immunization rates or doctors who submitted more than 5 exemptions.

Iconic California sequoias. Not related to vaccines. Photo by Victoria Palacios on Unsplash

Examining the SB276 compromises

So a medical exemption for a child in a school with high rates, whose physician only grants a very rare exemption, will not be reviewed.

I think this is a reasonable compromise for SB276. It creates criteria to identify problem spots – problem schools and problem doctors – but saves concerns and efforts for those in non-trouble spots. Yes, it may mean that some children will not face oversight, but there are other measures to oversee problem doctors, and limiting oversight to problem spots would probably already happen in practice, because of scarce resources.

For existing exemptions, the process is a bit more complex. They need to be submitted to the Department of Health by January 1, 2021, but to trigger a review by the department, a local health officer has to determine that the exemption “is fraudulent or inconsistent with applicable federal Centers for Disease Control and Prevention (CDC), Federal Advisory Committee on Immunization Practices (ACIP),” and request review.

In both cases, if an exemption was found invalid the amended bill creates an appeal process. It also clarifies that the officer will be “clinically trained.”

It also broadens the grounds for exemptions: where previously only CDC contraindications and precautions could be valid, no other grounds could be allowed if they are “consistent with the relevant standard of care.”

These changes likely allow for more medical exemptions than under the original act, and more medical exemptions to stand, but they still create oversight. I am comfortable with allowing more discretion than CDC guidelines – extraordinary or complex cases may come up that do not completely fit the guidelines but still merit exemptions, and the process assures that doctors can address these cases while leaving in place a review.

Iconic Yosemite Valley. Also, it has nothing to do with vaccines. Photo by Aniket Deole on Unsplash

Oversight of physicians writing medical exemptions

Where SB276 adds very strong provisions is in relation to the physicians writing medical exemption. One reason I am not very worried about the relaxation of some of the elements of the original bill is that these provisions, I think, give powerful tools to deal with physicians abusing their discretion.

First, as with the original bill, the physician needs to actually see the child – no more online or phone exemption.

Second, physicians who are not the child’s treating physician need to notify the child’s treating physician of the exemption. This allows the treating physician to respond to any misinformation in the exemption if needed. Further, they can – if they choose – file a complaint with the medical board against an abusive physician, based on their knowledge.

Third, the form requires the physician to clearly address the contraindication to each vaccine the child is exempt from – no more blanket exemptions from all vaccines for all time with no detailed explanation.

Fourth, the physicians need to certify, under pain of perjury, that the information in the form is accurate. It is unclear whether the state will aggressively act against physicians who are found to have been less than fully truthful on the act, but the possibility of a criminal sanction provides a big stick in the background.

Fifth, the amended bill provides that the parents agree to release the records related to the exemption as part of the medical record form, solving the problems the medical board faced in retrieving records from parents to investigate a claim of fake exemptions.

Sixth, physicians cannot charge for filing an exemption form (though they can charge for an examination), or for renewing a temporary medical exemption (a direct response to the practice of some doctors that only wrote temporary exemptions and made money by charging for renewal).

Finally, and most importantly, the amended bill gives the department of health powers to stop accepting exemptions from a physician in two circumstances:

if the department determines that a doctor poses a risk to public health,

or if there is a pending accusation before the medical board related to “immunization standard”.

In other words, the department can completely shut off the ability of an abusive doctor to write exemptions. Together, these provisions make it much harder for doctors to abuse their discretion and write fake exemptions. I think the stronger oversight more than makes up for any weakening of the process.

An iconic image of California’s Mt. Shasta (with several extant glaciers). It has nothing to do with vaccines. Photo by Marco Bicca on Unsplash

The SB276 hearing and review

Opponents made much of SB276 requiring a doctor that writes more than five exemptions would be subject to review; and some doctors – for example, those routinely treating children with cancer, may indeed write more exemptions than others. But a review does not mean rejection – physicians treating vulnerable children who should be exempt can write many exemptions, and those will be reviewed and should be approved.

So what happened today? The usual format of such a hearing is an introduction of the bill by its sponsoring legislatures, testimony from both sides – time-limited expert witness testimony, and not time-limited “me toos” – people saying their name, affiliation, and whether they support or oppose the bill. Then there is a discussion by committee members, and then a vote.

The procedure followed that process, but there were some interesting things. There was a morning discussion, and the discussion of the bill started at around 10:40 and went until around 5.

Anticipating a large and aggressive anti-vaccine crowd, the assembly members prepared carefully, allocating an outside area to them and making clear that the number allowed in the building will be carefully limited (to 700 – not a small number), and members will be allowed in to express their support in batches.

The supporters were also provided space, separately, and aside from the few allowed in the room, watched the proceeding on a screen and only went into the room to express support.

Opponents brought with them signs – likely to get around the fact that they were not allowed to speak during the “me toos” – and had yellow stickers saying “lie” on their hands to lift.

Opponents held a rally at 8:30, and gave speeches. Among other things, anti-vaccine activists Robert F. Kennedy Jr. compared the bill to the way Jews were treated in the Holocaust, leading the Jewish Caucus of California to call the comparison out:

.@RobertKennedyJr – Please stop making comparisons between the Holocaust and vaccines. It's offensive. — CA Jewish Caucus (@CAJewishCaucus) June 20, 2019

Testifying in support of SB276 was a mother of an immunocompromised child who explained the risk fake exemptions pose to vulnerable children, a representative of the California Medical Association, and a health officer. The “me-toos” included representatives of several important organizations, including teachers, nurses, doctors.

Much of the work of organizing the supporters, and on amending the bill, was done by the bill sponsors, including the American Academy of Pediatrics-CA , the California Medical Association, and the grassroots organization Vaccinate California lead by Ms. Leah Russin. Vaccinate California had a leading role at organizing the supporters on site.

The opponents brought several witnesses from out of state, including Attorney Kim Mack Rosenberg from New York and Robert F. Kennedy Junior. They also presented a parent of an alleged vaccine-injured child, and two doctors, including Dr. Bob Sears, who has been – and is – under investigation by the medical board, among other things for fake medical exemptions.

Robert F. Kennedy was, apparently, supposed to testify, but the other witnesses used up the allotted time. Anti-vaccine activists complained about that, but the time allotted was equal between the sides – if anything, the opponents got extra time, since one witness who was signed up as neutral was clearly opposed to the bill.

The opponents “me-toos” were lengthy, as many people presented their opposition. Many held signs or tried to give additional comments, and in some cases, the microphone had to be shut down.

After the testimony, the committee discussed the bill – with Dr. Pan fielding many questions. Dr. Pan’s behavior throughout was impressive – in the face of angry sounds from the opponents, and more than one nasty comment, he remained cool, collected and professional, answering questions – some repeated – patiently and at length.

The final vote was 9 for the bill, 2 opposed, and 2 abstaining.

Opponents, visibly very upset after the vote, remain in the building, singing songs and shouting slogans.

SB276 is now moving to the Assembly appropriations committee, and if successful there, to the assembly floor and to the desk of the Governor, who has already expressed support of the amended bill.

Update 4 September 2019

The California legislature advanced SB276, sending it to Governor Gavin Newsom for his signature. SB276 would crackdown on unethical medical exemptions for vaccines, which the anti-vaccine religion has abused in response to SB277, a 2015 law that eliminated personal belief exemptions to vaccination for children entering school.

On 3 September 2019, the bill passed by an overwhelming 47-17 vote in the strongly Democratic-controlled Assembly. It was sent to the California Senate, which previously passed the bill but the Assembly added amendments that required a revote. On 4 September, the California Senate approved the bill by another overwhelming 28-11 vote.

Like with SB277, Senator Dr. Richard Pan, MD led the effort to get the California legislature to pass SB276. Unfortunately, it appears that Governor Newsom is asking for a new bill to make some changes. At this time, we are unsure as to what is being requested – this article will be updated with further information as we know more.

Update 9 September 2019

After the California legislature overwhelmingly voted to pass SB276, it appeared that Governor Newsom was waffling on signing SB276. According to LA Times’ Melody Gutierrez, Dr. Pan and Gov. Newsom have come to an agreement to get SB276 signed into law:

Key California lawmakers agreed to scale back a bill to tighten rules for school vaccine exemptions after Gov. Gavin Newsom raised last-minute concerns, but the deal is likely to be met with fierce opposition from protesters who had hoped the governor’s apprehension signaled trouble for Senate Bill 276. The agreement between state Sen. Richard Pan (D-Sacramento) and Newsom calls for the governor to sign Senate Bill 276, which has already passed the Legislature, and for revisions to be placed in SB 714, which would still need approval by the Assembly and Senate by Sept. 13. The changes include Newsom’s proposal to grandfather in all existing medical exemptions before Jan. 1, with critics worried this would create a potential rush for new vaccine exemptions.

Also according to Ms. Guttierez, there was a provision of the bill that limits the length of time that these new exemptions would be allowed:

New medical exemptions would be required when a child enters kindergarten, seventh grade or changes schools. By adding that provision, permanent medical exemptions would no longer be valid throughout a child’s K-12 education. Temporary medical exemptions that currently allow a doctor to use his or her discretion as to the length of time they remain valid would be limited to one year under the deal reached Friday.

Moreover, the medical exemption will be invalidated if a physician is subject to a future disciplinary action from the California Medical Board with respect to exemptions. And that board has been strongly in support of SB276, and they are aggressively pursuing actions against many physicians who are doling out these inappropriate medical exemptions.

Governor Newsom has indicated he will sign SB276 once SB714 is passed by both houses and reaches his desk. I’m not sure when that will happen, but it needs to happen before 13 September 2019.

Notes

This article is by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.

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