(Without Reference to File)

SENATE THIRD READING

STR Bill Id:SB 276

Author:(Pan)

As Amended Ver:July 1, 2019

Majority vote

SUMMARY:

Requires the Department Public Health (DPH) to annually review immunization reports from all schools and institutions (i.e. daycare centers) to identify medical exemptions (MEs) subject to review. Requires a clinically trained DPH staff member to review MEs from schools or institutions with an immunization rate of less than 95% or physicians and surgeons who submit five or more medical exemptions in a calendar year. Permits DPH to deny or revoke a ME determined to be inappropriate or invalid, as specified. Establishes an appeals process for MEs that are denied or revoked and creates an independent review panel made up of three physicians for purposes of appeals.

Major Provisions:

1. Standardized ME Form. Requires DPH to develop a standardized form for MEs. Requires the form to include the specified information: a) information about the granting physician and the child; b) the medical reason for the exemption and whether it is temporary or permanent; c) a certification that a physical exam was conducted and that all included information is accurate; and, d) authorization for the release of medical records related to the ME. Requires all MEs obtained on or after January 1, 2021 to be submitted using this form to be valid. Requires MEs obtained before January 1, 2021 to be submitted in any form to DPH to be included in the database to be valid.
2. Review of MEs. Requires DPH to annually review immunization reports from all schools and institutions and identify those that are subject to review. Requires a clinically trained immunization staff from DPH must review all MEs when either schools or institutions which are found to have an immunization rate of less than 95%; or, a physician is found to have submitted five or more MEs annually. Requires, under these reviews, DPH to identify those MEs forms that do not meet applicable Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices, or American Association of Pediatrics criteria for appropriate MEs. Permits DPH, based on the medical discretion of the clinically trained immunization staff member, to accept a ME that is based on other contraindications or precautions, including consideration of family medical history, if the issuing physician provides written documentation to support the ME that is consistent with the relevant standard of care. If a ME is determined as inappropriate or invalid, the State Public Health Officer or physician designee will also review these exemptions to determine whether to deny or revoke a ME.
3. Appeals. Requires the Secretary of the California Health and Human Services (CHHS) to appoint an independent panel of primary care or immunization expert physicians to hear the appeals permitted by parents or guardians regarding revoked MEs. Requires the CHHS Secretary's final decision to be consistent with the findings of the independent expert review panel and is not subject to further administrative review.

COMMENTS:

In California, where vaccine laws are some of the strictest in the nation and personal belief exemptions based on religious or philosophical objections are no longer permitted since the passage of SB 277 (Pan), Chapter 35, Statutes of 2015. MEs from vaccines, under current law are permitted at the discretion of a physician, and have increased since the passage of SB 277. According to the 2018-2019 Kindergarten Immunization Assessment report published by the DPH Immunization Branch, approximately 20% of schools and institutions have been identified to have immunization rates under 95%. Following the implementation of SB 277, there was an increase in MEs in California. According to the Medical Board of California (MBC), since the passage of SB 277, there have been 173 confirmed complaints against 66 physicians regarding suspect MEs. Additionally, there are 104 pending complaints among 52 physicians. The MBC has taken action against one physician. However, the MBC states that the investigations into complaints related to immunization standard of care have had to be dismissed because of insufficient evidence.

According to the Author:

According to the author, the number of MEs issued more than tripled since the passage of SB 277. Many of the exemptions are clustered in the same schools, creating concentrated pockets of unvaccinated individuals. The author states that while the vast majority of physicians uphold standards of care, a small number of unethical physicians have monetized their license by selling MEs for profit. Currently, California law requires no state-level oversight or standardization of exemptions. As a result, MEs often contain incomplete information and may be issued for reasons other than medically-justified contraindications. The author concludes that this bill will restore integrity to California's immunization exemption process.

Arguments in Support:

According to one of the sponsors of this bill, the California Medical Association (CMA), high levels of immunization are necessary to, through a process called "community immunity," protect those who are unable to be immunized against vaccine-preventable illness.

Arguments in Opposition:

Advocates for Physicians' Rights (APR), another organization opposed to this bill states that the Centers for Disease Control and Prevention guidelines generally do not recognize family health history of allergic reactions or side effects as a valid reason upon which to base a ME . APR concludes that this bill runs counter to long-accepted medical standards of care, which recognize family history as a strong predictor of medical outcomes, and will negate physicians' clinical judgment regarding statistically-likely harm to members of a family that share the same gene pool.

FISCAL COMMENTS:

Estimated costs of $2.5 million General Fund (GF) to DPH in 2019-20, $3.3 million GF in 2020-21 and $3 million GF ongoing annually. The cost estimate is subject to uncertainty, as it relies on a number of assumptions with respect to the number of exemptions, denials and appeals, as well as the labor costs for each review. This cost estimate includes $400,000 GF one-time for system improvements to the California Immunization Registry and ongoing costs for system maintenance. The remainder of the costs are for staffing and consultant services. Cost to the MBC and Osteopathic Medical Board of California are expected to be minor and absorbable. This estimate is also subject to uncertainty, given an unknown number of complaints and investigations.

VOTES:

SENATE FLOOR: 24-10-4

YES: Archuleta, Atkins, Beall, Bradford, Caballero, Dodd, Durazo, Glazer, Hertzberg, Hill, Hurtado, Jackson, Leyva, McGuire, Mitchell, Monning, Pan, Portantino, Rubio, Skinner, Stern, Umberg, Wieckowski, Wiener

NO: Bates, Borgeas, Chang, Grove, Jones, Moorlach, Morrell, Nielsen, Stone, Wilk

ABS, ABST OR NV: Allen, Galgiani, Hueso, Roth

ASM HEALTH: 9-2-4

YES: Wood, Aguiar-Curry, Bonta, Carrillo, Limón, McCarty, Ramos, Arambula, Santiago

NO: Burke, Waldron

ABS, ABST OR NV: Mayes, Bigelow, Flora, Nazarian

ASM APPROPRIATIONS: 11-4-3

YES: Gonzalez, Bloom, Bonta, Calderon, Carrillo, Eggman, Gabriel, Eduardo Garcia, Petrie‑Norris, Quirk, Robert Rivas

NO: Brough, Diep, Fong, Obernolte

ABS, ABST OR NV: Bigelow, Chau, Maienschein

UPDATED:

VERSION: July 1, 2019

CONSULTANT: Marissa Kraynak and Rosielyn Pulmano / HEALTH / (916) 319-2097 FN: 0001681

 UNFINISHED BUSINESS 

Bill No: SB 276

Author: Pan (D), et al.

Amended: 7/1/19

Vote: 21

SENATE HEALTH COMMITTEE: 7-2, 4/24/19

AYES: Pan, Durazo, Hurtado, Leyva, Mitchell, Monning, Rubio

NOES: Stone, Grove

SENATE APPROPRIATIONS COMMITTEE: 4-2, 5/16/19

AYES: Portantino, Bradford, Hill, Wieckowski

NOES: Bates, Jones

SENATE FLOOR: 24-10, 5/22/19

AYES: Archuleta, Atkins, Beall, Bradford, Caballero, Dodd, Durazo, Glazer, Hertzberg, Hill, Hurtado, Jackson, Leyva, McGuire, Mitchell, Monning, Pan, Portantino, Rubio, Skinner, Stern, Umberg, Wieckowski, Wiener

NOES: Bates, Borgeas, Chang, Grove, Jones, Moorlach, Morrell, Nielsen, Stone, Wilk

NO VOTE RECORDED: Allen, Galgiani, Hueso, Roth

ASSEMBLY FLOOR: 48-19, 9/3/19 - See last page for vote

SUBJECT: Immunizations: medical exemptions

SOURCE: American Academy of Pediatrics, California

California Medical Association

Vaccinate California

DIGEST:

1. This bill requires the Department of Public Health (DPH) to develop an electronic, statewide, standardized medical exemption request form for immunization requirements in existing law. This bill requires DPH to make the request form available for use by physicians and to be transmitted directly to a state database. This bill requires the request form to be the only medical exemption documentation that a governing authority may accept. This bill requires DPH to create a standardized system to monitor immunization levels in schools and institutions, and to monitor patterns of unusually high exemption form submissions by a particular physician.

Assembly Amendments

:

1. Add legislative intent language.
2. Recast provisions requiring DPH to develop a standardized form for medical exemptions and provisions related to DPH review and approval or denial of medical exemptions.
3. Require DPH, by January 1, 2021, to create a standardized system to monitor immunization levels in schools and institutions, and to monitor patterns of unusually high exemption form submissions by a particular physician or medical practice.
4. Prohibit an issuing physician from charging for filling out a medical exemption form or for an examination related to the renewal of a temporary medical exemption.
5. Require DPH to annually review immunization reports from all schools and institutions in order to identify medical exemption forms.
6. Require the California Health and Human Services (CHHS) Secretary to appoint an independent expert review panel (IERP), consisting of three licensed physicians who are primary care physicians or immunization experts, to review appeals.

ANALYSIS:

Existing law:

1. Requires DPH to examine the causes of communicable disease in man and domestic animals occurring or likely to occur in this state. [HSC §120125]
2. Gives the State Public Health Officer (PHO), as the Director of DPH, broad authority to detect, monitor, and prevent the spread of communicable disease in the state, including the ability to:
   1. Require reporting of communicable disease that DPH identifies, on timelines and in a manner determined by DPH;
   2. Adopt and enforce regulations requiring strict or modified isolation, or quarantine, for any of the contagious, infectious, or communicable diseases, if in the opinion of DPH, the action is necessary for the protection of the public health;
   3. Take measures as are necessary to ascertain the nature of the disease and prevent its spread. Permits DPH, to that end, if it considers it proper, to take possession or control of the body of any living person, or the corpse of any deceased person;
   4. Quarantine, isolate, inspect, and disinfect persons, animals, houses, rooms, other property, places, cities, or localities, whenever in its judgment the action is necessary to protect or preserve the public health; and,
   5. Destroy such objects as bedding, carpets, household goods, furnishings, materials, clothing, or animals, when ordinary means of disinfection are considered unsafe, and when the property is in its judgment, an imminent menace to the public health. [HSC §120130, et seq.]
3. Requires a local health officer (LHO) knowing or having reason to believe that any case of reportable diseases, or any other contagious, infectious or communicable disease exists, or has recently existed, within the territory under his or her jurisdiction, to take measures as may be necessary to prevent the spread of the disease or occurrence of additional cases. [HSC §120175]
4. Prohibits the governing authority of a school or other institution from unconditionally admitting any person as a pupil of any private or public elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center, unless, prior to his or her first admission to that institution, he or she has been fully immunized against diphtheria, haemophilus influenzae type b (Hib), measles, mumps, pertussis, poliomyelitis, rubella, tetanus, hepatitis b (except after 7th grade), and chickenpox, as specified. [HSC §120335]
5. Permits DPH to add to this list any other disease deemed appropriate, taking into consideration the recommendations of Advisory Committee on Immunization Practices (ACIP), and the American Academy of Pediatrics (AAP) Committee on Infectious Diseases. [HSC §120335]
6. Waives the above immunization requirements if the parent or guardian files with the governing authority a written statement by a licensed physician to the effect that the physical condition of the child is such, or medical circumstances relating to the child are such, that immunization is not considered safe, indicating the specific nature and probable duration of the medical condition or circumstances including, but not limited to, family medical history, for which the physician does not recommend immunization. [HSC §120370(a)]
7. Permits a child for whom the requirement has been waived, if there is good cause to believe that a child has been exposed to one of the specified communicable diseases and the child’s proof of immunization status does not show proof of immunization against that disease, to be temporarily excluded from the school or institution until the LHO is satisfied that the child is no longer at risk of developing or transmitting the disease. [HSC §120370(b)]

This bill:

1. Requires DPH, by January 1, 2021, to develop and make available for use by licensed physicians an electronic, standardized, statewide medical exemption certification form that is transmitted directly to the California Immunization Registry (CAIR). Requires the form to be printed, signed, and submitted directly to the school or institution at which the child will attend, submitted directly to the governing authority of the school or institution, or submitted to that governing authority through the CAIR where applicable.
2. Requires the standardized for, beginning January 1, 2021, to be the only documentation of a medical exemption that a governing authority may accept. Requires a parent, if a medical exemption has been authorized pursuant to existing law and prior to the adoption of the statewide standardized form, to submit, by January 1, 2021, a copy of the medical exemption to DPH for inclusion in a state database in order for the medical exemption to remain valid
3. Requires the form to require, at a minimum:
   1. The name, California medical license number, business address, and telephone number of the physician who issued the medical exemption, and of the primary care physician of the child, if different from the physician who issued the medical exemption;
   2. The name of the child for whom the exemption is sought, the name and address of the child’s parent or guardian, and the name and address of the child’s school or other institution;
   3. A statement certifying that the physician has conducted a physical examination and evaluation of the child consistent with the relevant standard of care and complied with all applicable requirements of this bill;
   4. Whether the physician who issued the medical exemption is the child’s primary care physician. Requires the issuing physician, if he or she is not the child’s primary care physician, to provide an explanation as to why the issuing physician and not the primary care physician is filling out the medical exemption form;
   5. How long the physician and surgeon has been treating the child;
   6. A description of the medical basis for which the exemption for each individual immunization is sought. Requires each specific immunization to be listed separately and space on the form to be provided to allow for the inclusion of descriptive information for each immunization for which the exemption is sought;
   7. Whether the medical exemption is permanent or temporary, including the date upon which a temporary medical exemption will expire. Prohibits a temporary exemption from exceeding one year;
   8. An authorization for DPH to contact the issuing physician, as specified; and,
   9. A certification by the issuing physician, under penalty of perjury, that the statements and information contained in the form are true, accurate, and complete.
4. Prohibits an issuing physician from charging for filling out a medical exemption form or for a physical examination related to the renewal of a temporary medical exemption.
5. Requires an issuing physician, commencing January 1, 2021, if a parent or guardian requests a physician to submit a medical exemption for the parent’s or guardian’s child, to inform the parent or guardian of the requirements of this bill. Requires the issuing physician, if the parent or guardian consents, to examine the child and submit a completed medical exemption certification form to DPH. Permits a medical exemption certification form to be submitted to at any time.
6. Requires DPH, by January 1, 2021, to create a standardized system to monitor immunization levels in schools and institutions, and to monitor patterns of unusually high exemption form submissions by a particular physician.
7. Requires a clinically trained immunization DPH staff member to review all medical exemptions from: schools or institutions with an immunization rate of less than 95%; physicians who have submitted five or more medical exemptions in a calendar year; or, schools or institutions that do not provide reports of vaccination rates to DPH.
8. Requires DPH to identify those medical exemption forms that do not meet applicable the Centers for Disease Control and Prevention (CDC), ACIP, or AAP criteria for appropriate medical exemptions. Permits DPH to contact the primary care or issuing physician to request additional information to support the medical exemption.
9. Permits DPH, based on the medical discretion of the clinically trained immunization staff member, to accept a medical exemption that is based on other contraindications or precautions, including consideration of family medical history, if the issuing physician provides written documentation to support the medical exemption that is consistent with the relevant standard of care.
10. Requires medical exemptions found to be inappropriate or otherwise invalid to also be reviewed by the PHO or a designated physician from DPH’s immunization program. Permits the PHO or his/her designee to revoke the medical exemption, as applicable.
11. Requires DPH to notify the parent or guardian, issuing physician, the school or institution, and the LHO with jurisdiction over the school or institution of a denial or revocation.
12. Requires a child continue in attendance if a medical exemption is revoked pursuant to this bill. Requires the child, within 30 calendar days of the revocation, to commence the immunization schedule required for conditional admittance under existing law in order to remain in attendance, unless an appeal within that 30-day time period, in which case the child will continue in attendance and will not be required to otherwise comply with immunization requirements unless and until the revocation is upheld on appeal.
13. Requires DPH, if it determines that a physician’s practice is contributing to a public health risk in one or more communities,  to report the physician and surgeon to the Medical Board of California (MBC) or the Osteopathic Medical Board of California (OMBC), as appropriate. Prohibits DPH from accepting a medical exemption form from the physician until he/she demonstrates that the risk no longer exists. Specifies that in no event the physician and surgeon will be barred from submitting these forms for less than two years.
14. Prohibits DPH from accepting a medical exemption from a physician with a pending accusation with the MBC or the OMBC relating to immunization standards of care, unless and until the accusation is resolved in favor of the physician and surgeon.
15. Requires DPH to notify the MBC or OMBC, as appropriate, of any physician who has five or more medical exemption forms in a calendar year that are revoked.
16. Permits a clinically trained immunization program staff member to review any exemption in the CAIR or other state database as necessary to protect public health.
17. Requires DPH, the MBC, and the OMBC to enter into a memorandum of understanding or similar agreement to ensure compliance with the requirements of this bill.
18. Requires DPH to establish the process and guidelines for review of medical exemptions and to communicate the process to providers and post this information on its Web site.
19. Requires DPH or CHHS, if it determines that contracts are required to implement this bill, to award these contracts on a single-source or sole-source basis, as specified. Permits DPH to implement this bill through provider bulletins, or similar instructions, without taking regulatory action. Exempts DPH and CHHS from the rulemaking and administrative adjudication provisions in the Administrative Procedure Act.
20. Requires the CHHS Secretary to establish an IERP, consisting of three licensed physicians and surgeons who have relevant knowledge, training, and experience relating to primary care or immunization to review appeals. Requires CHHS to establish the process and guidelines for the appeals process and to post this information on its Web site. Requires CHHS to establish requirements, including conflict-of-interest standards, consistent with the purposes of this bill, that a physician is required to meet in order to qualify to serve on the panel.
21. Requires the IERP to evaluate appeals consistent with CDC, ACIP, or AAP guidelines and the relevant standard of care, as applicable.
22. Requires the IERP to submit its determination to CHHS. Requires CHHS to adopt the determination of the IERP and promptly issue a written decision to the child’s parent or guardian. Prohibits the decision from being subject to further administrative review.
23. Requires a child whose medical exemption revocation to commence the immunization required for conditional admittance, provided that the appeal is filed within 30 calendar days of revocation of the medical exemption.
24. Permits a revoked medical exemption to be appealed by a parent or guardian to the CHHS Secretary. Permits parents or guardians to provide necessary information for purposes of the appeal.
25. Requires DPH and IERP to comply with all applicable state and federal privacy and confidentiality laws, and may disclose information submitted in the medical exemption form.

Comments

Author’s statement. According to the author, in the first four months of 2019, 465 measles cases have been reported across 19 states, a number far surpassing last year’s number of cases. Since elimination of measles in the U.S. in 2000, this is the second greatest number of cases reported. SB 277 (Pan and Allen, Chapter 35, Statutes of 2015) eliminated all non-medical exemptions for immunizations required for school entry. While SB 277 was successful in raising immunization rates, the number of medical exemptions issued more than tripled since the law went into effect. Many of the exemptions are clustered in the same schools, creating concentrated pockets of unvaccinated individuals. At almost 60 schools in the state, more than 10% of kindergarteners had medical exemptions. According to PHO, the rise in medical exemptions is associated with an increase in physicians issuing exemptions for children without medically-justified contraindications. While the vast majority of physicians uphold standards of care, a small number of unethical physicians have monetized their license by selling medical exemptions for profit. Currently, California law requires no state-level oversight or standardization of exemptions. As a result, medical exemptions often contain incomplete information and may be issued for reasons other than medically-justified contraindications. This bill will restore integrity to California’s exemption process.

NOTE: Please see policy committee analyses for more complete background.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Assembly Appropriations Committee, estimated costs of $2.5 million General Fund (GF) to DPH in 2019-20, $3.3 million GF in 2020-21 and $3 million GF ongoing annually. The cost estimate is subject to uncertainty, as it relies on a number of assumptions with respect to the number of exemptions, denials and appeals, as well as the labor costs for each review. This cost estimate includes $400,000 GF one-time for system improvements to the CAIR and ongoing costs for system maintenance. The remainder of the costs are for staffing and consultant services. Cost to the MBC and OMBC are expected to be minor and absorbable. This estimate is also subject to uncertainty, given an unknown number of complaints and investigations.

SUPPORT: (Verified 9/3/19)

American Academy of Pediatrics, California (co-source)

California Medical Association (co-source)

Vaccinate California (co-source)

Advanced Medical Technology Association

AIDS Healthcare Foundation

American College of Cardiology, California Chapter

American College of Physicians, California Chapter

Bikur Cholim Jewish Healthcare Foundation

California Academy of Eye Physicians and Surgeons

California Academy of Family Physicians

California Academy of Pain Medicine

California Academy of Preventative Medicine

California Allergy, Asthma and Immunology Society

California Association of Professional Scientists

California Chapter American College of Cardiology

California Children’s Hospital Association

California Chronic Care Coalition

California Hospital Association

California Immunization Coalition

California Life Sciences Association

California Optometric Association

California Orthopaedic Association

California School Nurses Organization

California Society for Asthma, Allergy, and Immunology

California Society of Health-System Pharmacists

California State Association of Counties

California State PTA

Children Now

Children’s Defense Fund

Children’s Specialty Care Coalition

Contra Costa County Board of Supervisors

County Health Executives Association of California

County of Los Angeles, Board of Supervisors

County of Marin

County of Santa Clara

Donate Life California

First 5 California

Health Officers Association of California

Infectious Disease Association of California

Kaiser Permanente

LA Care Health Plan

Los Angeles County Board of Supervisors

March of Dimes

Marin County Board of Supervisors

Medical Board of California

Orthopedic Surgery Specialists Medical Group

Providence St. Joseph Health

Santa Barbara County Board of Supervisors

Santa Cruz County

Sonoma County Health Action Committee for Healthcare Improvement

Sutter Health

The Helm Center

United Democratic Club

West Hills Neighborhood Council

Over 700 individuals

OPPOSITION: (Verified 9/3/19)

A Voice for Choice Advocacy

Adoption Health Advocates

Advocates for Physicians’ Rights

Alliance for Natural Health USA

Association of American Physicians and Surgeons

Autismone

California Health Coalition Advocacy

California Right to Life Committee, Inc.

Californians for Trusted Healthcare

Concerned Physicians

Eagle Forum of California

Educate.Advocate.

Hope Inc. Academy

Ladies with Babies

Los Angeles Moms

Moms Across America

National Health Freedom Action

National Vaccine Information Center

Orange County Health Choice

Pacific Justice Institute – Center for Public Policy

ParentalRights.org

Physicians for Informed Consent

Physicians’ Association for Anthroposophic Medicine

Protection of the Educational Rights of Kids

Vaccine-Injury Awareness League

West Virginians for Health Freedom

Over 800 individuals

ASSEMBLY FLOOR: 48-19, 9/3/19

AYES: Aguiar-Curry, Arambula, Bauer-Kahan, Berman, Bloom, Bonta, Calderon, Carrillo, Chau, Chiu, Chu, Cooper, Daly, Eggman, Gabriel, Cristina Garcia, Gipson, Gloria, Gonzalez, Grayson, Holden, Irwin, Jones-Sawyer, Kalra, Kamlager-Dove, Levine, Limón, Low, McCarty, Mullin, Petrie-Norris, Quirk, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Salas, Santiago, Smith, Mark Stone, Ting, Weber, Wicks, Wood, Rendon

NOES: Brough, Burke, Chen, Choi, Cunningham, Diep, Flora, Fong, Gallagher, Gray, Kiley, Lackey, Mathis, Medina, Melendez, Obernolte, O'Donnell, Voepel, Waldron

NO VOTE RECORDED: Bigelow, Boerner Horvath, Cervantes, Cooley, Frazier, Friedman, Eduardo Garcia, Maienschein, Mayes, Muratsuchi, Nazarian, Patterson

Prepared by: Melanie Moreno / HEALTH / (916) 651-4111

9/3/19 19:31:47

**** END ****

Date of Hearing: July 10, 2019

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

SBPCA Bill Id:SB 276

Author:(Pan) – As Amended Ver:July 1, 2019

Urgency: No State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill increases state oversight of medical exemptions to mandatory vaccinations required for school entry and standardizes reporting of such exemptions. Specifically, this bill:

1. Requires the California Department of Public Health (CDPH) to develop and make available an electronic, standardized statewide medical exemption certification form, as specified, to be transmitted directly to the department’s electronic California Immunization Registry (CAIR), and requires the form to be submitted to the school or relevant governing authority. Makes the standardized form, as of January 1, 2021, the only acceptable documentation of a medical exemption.
2. Requires CDPH, by January 1, 2021, to create a standardized system to monitor immunization levels in schools and institutions and to monitor patterns of unusually high exemption form submissions by a particular physician.
3. Requires a clinically trained immunization department staff member (physician or registered nurse) to review medical exemptions from the following:
   1. Schools or institutions with an overall immunization rate of less than 95%.
   2. Physicians who have submitted five or more medical exemptions in a calendar year.
   3. Schools or institutions that do not provide reports of vaccination rates to the department.
4. Allows a clinically trained immunization program staff member to review any exemption in the CAIR or other state database as necessary to protect public health.
5. Requires exemptions the staff member determines to be inappropriate or otherwise invalid to be reviewed by the State Public Health Officer or a physician designee, and allows the State Public Health Officer or physician designee to revoke or deny the medical exemption.
6. Requires CDPH to notify the parent or guardian, issuing physician, school or institution, and appropriate local public health officer of a denial or revocation.
7. Establishes a process whereby parents may appeal a denial or revocation to the Secretary of California Health and Human Services—the exemption is reviewed for consistency with relevant guidelines and standards of care by an independent expert review panel comprised of three licensed physicians. Requires the secretary to adopt the panel’s determination and specifies the decision is not subject to further administrative review.
8. Specifies school attendance is allowed while an exemption is being reviewed or appealed.
9. Prohibits CDPH from accepting a medical exemption form from a physician with a pending accusation with the Medical Board of California (MBC) or the Osteopathic Medical Board of California (OMBC) relating to immunization standards of care.
10. Requires CDPH to report to MBC or OMBC if the department determines a physician’s practice is contributing to a public health risk in one or more communities, and prohibits CDPH from accepting a medical exemption form from the physician for at least two years and until the physician demonstrates the public health risk no longer exists.
11. Requires CDPH to notify MBC or OMBC of any physician and surgeon who has issued five or more medical exemption forms in a calendar year that have been revoked.
12. Prohibits a physician from charging for filling out a medical exemption form or a physical examination related to the renewal of a temporary medical exemption.
13. Requires CDPH to enter into a memorandum of understanding or similar agreement with MBC and OMBC to ensure compliance with this bill.
14. Exempts CDPH from regulatory requirements of the Administrative Procedure Act and public contracting laws for purposes of implementing this bill.
15. Contains other provisions further specifying various operational details.

FISCAL EFFECT:

1. Estimated costs of $2.5 million GF to CDPH in 2019-20, $3.3 million GF in 2020-21 and $3 million GF ongoing annually. The cost estimate is subject to some uncertainty, as it relies on a number of assumptions with respect to the number of exemptions, denials and appeals, as well as the labor costs for each review. This cost estimate includes $400,000 GF one-time for system improvements to the California Immunization Registry and ongoing costs for system maintenance. The remainder of the costs are for staffing and consultant services.
2. Costs to the Medical Board of California and the Osteopathic Medical Board of California are expected to be minor and absorbable (special funds). This estimate is also subject to uncertainty, given an unknown number of complaints and investigations.

COMMENTS:

1. Purpose. According to the author, the lack of state-level oversight or standardization of medical exemptions to mandatory vaccination laws have allowed for exemptions that may not be medically justified. The author believes this bill will restore integrity to California’s immunization exemption process and is necessary to maintain sufficient levels of community immunity to vaccine-preventable diseases.
2. Background. Like other states, California mandates immunization of school-aged children against diseases specified in law (Diphtheria, Haemophilus influenzae type b (Hib), Measles, Mumps, Pertussis, Poliomyelitis, Rubella, Tetanus, Hepatitis b (except after 7th grade) and Chickenpox). Specifically, children in California are required to receive these immunizations to attend public and private elementary and secondary schools, child care centers, family day care homes, and child development centers. Schools and other entities are required to enforce immunization requirements, maintain immunization records of all children enrolled and report annually to CDPH. According to the 2018-2019 Kindergarten Immunization Assessment report published by the CDPH Immunization Branch, 94.8% of all children entering kindergarten for the 2018-2019 school year were up to date and on time with all required immunizations. However, children who have been exempted from vaccines are not evenly geographically distributed throughout the state. Some schools and communities have vaccination rates that are far below this overall number.
3. Vaccination Risks and Benefits. No vaccine is 100% effective in every person, or 100% risk-free. On balance, public health entities have concluded the disease-control benefits of vaccination on a population basis greatly exceed the risks. The Centers for Disease Control and Prevention (CDC) indicates serious reactions to vaccines are possible, but are rare. Less serious side effects such as fever and soreness are common.
4. Herd Immunity. Given measles and other diseases are no longer endemic to California due to widespread vaccination, an unvaccinated child may still have a low risk of contracting measles in California today because the child is protected by the “herd immunity” of the surrounding community or school. If that immunity wanes due to a reduction in vaccination rates, however, many of the diseases for which vaccination is recommended would reemerge quickly. For vaccination to dramatically reduce or eliminate disease transmission, vaccination rates must be very high; for example, preventing transmission of measles requires vaccination rates of up to 95%. As noted, some schools and communities report high exemption rates that leave them vulnerable to the spread of vaccine-preventable diseases. Individuals who have medical contraindications to vaccines rely on herd immunity for protection from such diseases.
5. Recent History of Exemptions to Vaccination in California. Prior to 2013, California allowed for exemptions to immunization based on personal beliefs. To address a rise in this type of exemption and a corresponding decrease in herd immunity, SB 2109 (Pan), Chapter 821, Statutes of 2012, required a parent to submit a form acknowledging a health care professional had provided information to the parent or guardian regarding the benefits and risks of immunization, including the health risks to the student and the community resulting from declining the recommended immunizations. Three years later, SB 277 (Pan and Allen), Chapter 35, Statutes of 2015, eliminated all non-medical exemptions for immunizations required for school entry. Since the elimination of personal belief exemptions, the number of medical exemptions has increased substantially, especially at private schools. Overall, the number of medical exemptions is still under 1%, but a number of counties report much higher medical exemption rates.
6. Support. This bill is co-sponsored by the California Medical Association, American Academy of Pediatrics, California and Vaccinate California and is supported by a large number of children’s, public health and health care advocacy and professional groups. Supporters state the use of medical exemptions has more than tripled, putting many communities below the required protective immunization level, and this bill is necessary to protect herd immunity. Supporters also contend maintaining high vaccination levels also protects vulnerable community members, including babies too young to be immunized and people who are immunocompromised, from the risks associated with contracting these diseases and protects communities at large from outbreaks of vaccine-preventable disease.
7. Opposition. A Voice For Choice Advocacy, National Vaccine Information Center and numerous other organizations and individuals express opposition to this bill based on a multitude of concerns, including but not limited to the following:
   1. It represents an encroachment into the private doctor-patient relationship.
   2. The state will not be able to timely process exemptions.
   3. Individual susceptibility to vaccine reactions and vaccine providers cannot reliably predict who will be harmed.
   4. Violation of parental and informed consent rights.
   5. Lack of evidence that unscrupulous doctors are “selling fake medical exemptions.”
   6. Minimization of the likelihood and seriousness of vaccine-related injury.
   7. Significant costs to the state and to schools.
   8. Legal issues, including discrimination based on disability, privacy issues, violations of medical rights and the denial of education based on refusal to vaccinate.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: June 20, 2019

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

SBPCA Bill Id:SB 276

Author:(Pan) – As Amended Ver:June 17, 2019

SENATE VOTE: 24-10

SUBJECT: Immunizations: medical exemptions.

SUMMARY: Requires the Department Public Health (DPH) to annually review immunization reports from all schools and institutions to identify medical exemptions subject to review. Requires a clinically trained DPH staff member to review exemptions from schools or institutions with an immunization rate of less than 95% or physicians and surgeons who submit five or more medical exemptions in a calendar year. Permits DPH to deny or revoke a medical exemption determined to be inappropriate or invalid, as specified. Establishes an appeals process for medical exemptions that are denied or revoked and creates an independent review panel made up of three physicians for purposes of appeals. Requires DPH to create a standardized statewide form for the purpose of obtaining a medical exemption or medical exemptions for immunization requirements. Requires the form to include specific information, including the name; California medical license of the physician issuing the medical exemption; and, certification that the physician has conducted a physical examination and evaluation of the child consistent with the standard care. States that medical exemptions granted prior to January 1, 2021 that are founfd to be fraudulent or inconsistent, as specified, may be revoked or denied. Specifically, this bill:

1. Requires DPH, by January 1, 2021, to develop and make available for use by licensed physicians and surgeons an electronic, standardized, and statewide medical exemption certification form that will be transmitted directly using the existing California Immunization Registry (CAIR).
2. Requires medical exemption certification forms to be printed, signed, and submitted directly to the governing authority of the school or institution or to the governing authority of the school or institution through CAIR, when applicable.
3. Requires, commencing January 1, 2021, the standardized form to be the only documentation of a medical exemption that the governing authority can accept, except for those medical exemptions authorized prior to the adoption of the standardized form under this bill.
4. Requires the standardized form, at a minimum, to require all of the following information:
   1. The name, California medical license number, and business address and telephone number of the physician and surgeon who issued the medical exemption, and of the primary care physician (PCP) of the child, if different from the physician and surgeon who issued the medical exemption;
   2. The name of the child for whom the exemption is sought and the name and address of the child’s parent or guardian, and the name and address of the child’s school or institution;
   3. A statement certifying that the issuing physician and surgeon has conducted a physical examination and evaluation of the child consistent with the relevant standard of care, and complied with all the requirements of this bill;
   4. Whether the issuing physician and surgeon is the child’s PCP. Requires that if the issuing physician and surgeon is not the child’s PCP and has not been treating the child for at least one year, the issuing physician must attest that the PCP has been contacted and advised of the submission of the medical exemption form;
   5. A description of the medical basis for which the exemption for each individual immunization is sought. Requires each specific immunization to be listed separately and space to be provided on the form for the inclusion of descriptive information for each immunization for which the exemption is sought;
   6. Whether the medical exemption is permanent or temporary, including the date upon which a temporary medical exemption will expire. Prohibits a temporary exemption from exceeding one year;
   7. An authorization for DPH to contact the issuing physician for purposes of this bill and for the release of records related to the medical exemption to DPH, the Medical Board of California (MBC) and the Osteopathic Medical Board of California (OMB); and,
   8. A certification by the issuing physician and surgeon, under penalty of perjury, that the statements and information contained in the form are true, accurate, and complete.
5. Prohibits a physician and surgeon from charging for either of the following:
   1. Filling out a medical exemption form; or,
   2. An examination related to the renewal of a temporary medical exemption.
6. Requires, commencing January 1, 2021, if a parent or guardian requests a licensed physician and surgeon to submit a medical exemption for the parent’s or guardian’s child, the physician and surgeon to inform the parent or guardian of the requirements of this bill. Provides that if a parent or guardian consents, the physician and surgeon must examine the child and submit a completed medical exemption certification form to DPH. Allows a medical exemption form to be submitted to DPH at any time.
7. Requires DPH, by January 1, 2021, to create a standardized system to monitor immunization levels in schools and institutions as defined in existing law, and to monitor patterns of unusually high exemption form submissions by a particular physician and surgeon or a medical practice.
8. Permits DPH to review any medical exemption granted by a physician and surgeon before January 1, 2021. States the following for medical exemptions that were authorized prior to the adoption of the standardized form under this bill (prior to January 1, 2021):
   1. A parent or guardian must submit by January 1, 2021, a copy of the medical exemption to DPH for inclusion in CAIR in order for the medical exemption to remain valid;
   2. If the local health officer (LHO) determines that a medical exemption granted prior to January 1, 2021, and submitted to DPH is fraudulent or inconsistent with applicable Centers for Disease Control and Prevention (CDC), federal Advisory Committee on Immunization Practices (ACIP), or American Academy of Pediatrics (AAP) criteria for appropriate medical exemptions, the LHO may provide the information to the State Public Health Officer (SPHO) who may revoke the exemption upon the request of the LHO; and,
   3. Requires DPH to annually review immunization reports from all schools and institutions in order to identify medical exemptions granted prior to January 1, 2021, for inconsistencies with CDC, ACIP, and AAP guidelines.
9. Requires a clinically trained immunization DPH staff member to review all medical exemptions from either of the following:
   1. Schools or institutions with an immunization rate of less than 95%; and,
   2. Physicians and surgeons who have submitted five or more medical exemptions in a calendar year.
10. Requires DPH to identify those medical exemption forms that do not meet applicable CDC, ACIP, or AAP criteria for appropriate medical exemptions. Permits DPH to contact the PCP or issuing physician and surgeon to request additional information to support the medical exemption.
11. Permits DPH, based on the medical discretion of the clinically trained immunization staff member, to accept a medical exemption that is based on other contraindications or precautions, including the consideration of family medical history if the issuing physician and surgeon provides written documentation to support the medical exemption that is consistent with the relevant standard of care.
12. Requires any medical exemption that DPH’s reviewing immunization staff member determines to be inappropriate or otherwise invalid, under the review specified in 10) and 11) above, to also be reviewed by the SPHO or a physician and surgeon designee of the SPHO. Permits, under this review, the SPHO or physician and surgeon designee to deny or revoke a medical exemption, as applicable.
13. Requires DPH to notify the issuing physician and surgeon, the school or institution, and the LHO with jurisdiction over the school or institution of a denial or revocation of a medical exemption that is subject to review.
14. Requires a child to comply with the conditional admission schedule for immunization and continued attendance requirements specified in regulations in the case of a medical exemption that is denied, revoked, or pending appeal.
15. Prohibits DPH from accepting a medical exemption form from a physician and surgeon if it determines that a physician and surgeon poses a risk to the public’s health in one or more communities until the physician and surgeon demonstrates to DPH that the risk no longer exists, but in no event will a physician be barred from submitting their forms for less than two years.
16. Prohibits DPH from accepting medical exemption forms from a physician and surgeon with a pending accusation with the MBC or OMB relating to immunization standards of care until the accusation is resolved in favor of the physician and surgeon.
17. Requires DPH to notify the MBC and OMB, as appropriate, of the following:
    1. Physicians and surgeons that have issued medical exemption forms that have been denied or revoked under this bill; or,
    2. Physicians and surgeons who qualify under 15) above.
18. Permits a DPH clinically trained immunization staff member to review any exemption in CAIR as necessary to protect public health.
19. Requires DPH, MBC, and OMB to enter into a memorandum of understanding or similar agreement to ensure compliance with this bill.
20. Requires DPH and the independent review panel specified in 23) below, to comply with all applicable state and federal privacy and confidentiality laws and permits disclosure only in accordance with existing state and federal privacy and confidentiality laws.
21. Permits DPH, if it determines that contracts are required to implement this bill, to award these contracts on a single-source or sole-source basis and exempt from the public contract requirements, as specified. Permits DPH to implement and administer the provisions of this bill through provider bulletins or similar instructions without taking regulatory action.
22. Permits a parent or guardian to appeal the denial or revocation of a medical exemption to the California Health and Human Services (CHHS) Secretary. Permits parents and guardians to provide necessary information to the independent review panel for the appeal.
23. Requires the Secretary of CHHS to appoint an independent expert review panel, consisting of three licensed physicians and surgeons who are PCP or immunization experts, to review appeals. Requires CHHS to establish requirements, including conflict-of-interest standards, as specified, that a physician and surgeon is required to meet in order to qualify for an appointment to the panel.
24. Requires the independent expert review panel to evaluate appeals consistent with the CDC and ACIP guidelines and the relevant standard of care, as applicable.
25. Requires the independent expert review panel to submit its findings and recommendations to the secretary. Requires the CHHS Secretary’s final decision to be consistent with the findings of the independent expert review panel, and is not subject to further administrative review.
26. Requires the existing report filed by the governing authority of each school or institution of new entrants to be filed annually.
27. Makes other technical and conforming changes.
28. Finds and declares the importance of vaccines.

EXISTING LAW:

1. Establishes DPH to, among other functions, examine the causes of communicable diseases occurring or likely to occur in this state and as the entity mainly responsible for the prevention of communicable diseases.
2. Authorizes the SPHO, as the director of DPH, broad authority to detect, monitor, and prevent the spread of communicable disease in the state, including the ability to:
   1. Require the reporting of communicable diseases that DPH identifies, on timelines and in a manner determined by the DPH;
   2. Adopt and enforce regulations requiring strict or modified isolation, or quarantine, for any of the contagious, infectious, or communicable diseases, if in the opinion of DPH, the action is necessary for the protection of the public health;
   3. Take measures as are necessary to ascertain the nature of the disease and prevent its spread; and, allows DPH to take possession or control of the body of any living person, or the corpse of any deceased person, as specified;
   4. Quarantine, isolate, inspect, and disinfect persons, animals, houses, rooms, other property, places, cities, or localities, whenever in its judgment the action is necessary to protect or preserve the public health; and,
   5. Destroy such objects as bedding, carpets, household goods, furnishings, materials, clothing, or animals, when ordinary means of disinfection are considered unsafe, and when the property is in its judgment, an imminent menace to the public health.
3. Requires the SPHO to be a licensed physician and surgeon who has demonstrated medical, public health, and management experience.
4. Requires a LHO knowing or having reason to believe that any case of reportable diseases, or any other contagious, infectious or communicable disease exists, or has recently existed, within the territory under his or her jurisdiction, to take measures as may be necessary to prevent the spread of the disease or occurrence of additional cases.
5. Prohibits the governing authority of a school or other institution from unconditionally admitting any person as a pupil of any private or public elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center, unless, prior to his or her first admission to that institution, he or she has been fully immunized against the following diseases, as specified:
   
   1. Diphtheria;
   2. Haemophilus influenzae type b (Hib);
   3. Measles;
   4. Mumps;
   5. Pertussis;
   6. Poliomyelitis;
   7. Rubella;
   8. Tetanus;
   9. Hepatitis b (except after 7th grade); and,
   10. Chickenpox.
       
6. Requires the governing authority of each school or institution to require documentary proof of each entrant’s immunization status.
7. Requires the governing authority to record the immunizations of each new entrant in the entrant’s permanent enrollment and scholarship record on a form provided by DPH.
8. Requires the immunization record of each new entrant admitted conditionally to be reviewed periodically by the governing authority to ensure that they have been fully immunized against appropriate communicable diseases. Requires immunizations received after entry to be added to the pupil’s immunization record.

1. Prohibits any further admittance to school for a pupil admitted conditionally who failed to obtain the required immunizations within the time limits allowed in the regulations of DPH unless the pupil has obtained an authorized medical exemption. Permits admittance to a school or institution for a pupil that has become up to date with required immunizations.
2. Requires the governing authority to file a written report on the immunization status of new entrants to the school or institution under their jurisdiction with DPH and the local health department at times and on forms prescribed by DPH.
3. Requires the governing authority to cooperate with the county health officer in carrying out programs for the immunization of persons applying for admission to any school or institution under its jurisdiction. Permits the governing board of any school district to use funds, property, and personnel of the district for that purpose. Permits the governing authority of any school or other institution to permit any licensed physician or any qualified registered nurse to administer immunizing agents to any person seeking admission to any school or institution under its jurisdiction.
   
4. Permits DPH to add to the list of required immunizations any other disease deemed appropriate, taking into consideration the recommendations of the CDC, ACIP, and the AAP Committee on Infectious Diseases.
   
5. Waives the above immunization requirements if the parent or guardian files with the governing authority a written statement by a licensed physician to the effect that the physical condition of the child is such, or medical circumstances relating to the child are such, that immunization is not considered safe, indicating the specific nature and probable duration of the medical condition or circumstances including, but not limited to, family medical history, for which the physician does not recommend immunization.
   
6. Permits a child for whom the requirement has been waived, if there is good cause to believe that a child has been exposed to one of the specified communicable diseases and the child’s proof of immunization status does not show proof of immunization against that disease, to be temporarily excluded from the school or institution until the LHO is satisfied that the child is no longer at risk of developing or transmitting the disease.
   
7. Establishes the MBC, under the Medical Practice Act, and the OMB, under the Osteopathic Act, which, among other authorities, is the entity that conducts investigations of complaints against physicians and surgeon, including those relating to immunization practice standards of care.

FISCAL EFFECT: According to the Senate Appropriations Committee, up to $9.4 million in fiscal year (FY) 2019-20; $9.97 million in FY 2020-21; $10.8 million in FY 2021-22; $10.2 million in FY 2022-23, and $10.15 million in FY 2023-24. All costs to be borne by General Fund for DPH workload and staff to promulgate regulations, prepare appeals, and review exemption requests. In addition, staff anticipates possible contract costs, and ongoing operations costs, for the development and maintenance of a database and its security.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, since the start of 2019, 1,044 measles cases have been reported across 28 states, far surpassing last year’s number of cases. This is the greatest number of cases since 1992 and since 2000 when measles was declared eliminated. The author states that SB 277 (Pan and Allen), Chapter 35, Statutes of 2015, eliminated all non-medical exemptions for immunizations required for school entry. While SB 277 was successful in raising immunization rates, the number of medical exemptions issued more than tripled since the law went into effect. According to the author, many of the exemptions are clustered in the same schools, creating concentrated pockets of unvaccinated individuals. At almost 60 schools in the state, more than 10% of kindergarteners had medical exemptions. The rise in medical exemptions is associated with an increase in physicians issuing exemptions for children without medically-justified contraindications. While the vast majority of physicians uphold standards of care, a small number of unethical physicians have monetized their license by selling medical exemptions for profit. Currently, California law requires no state-level oversight or standardization of exemptions. As a result, medical exemptions often contain incomplete information and may be issued for reasons other than medically-justified contraindications. The author concludes that this bill will restore integrity to California’s immunization exemption process.
2. BACKGROUND. According to the CDC, diseases that used to be common in the U.S. and around the world, including polio, measles, diphtheria, pertussis (whooping cough), rubella (German measles), mumps, tetanus, rotavirus and Hib can now be prevented by vaccination. Due to vaccines, one of the most terrible diseases in history – smallpox – no longer exists outside the laboratory because of vaccines. Over the years vaccines have prevented countless cases of diseases and saved millions of lives. Vaccines work by utilizing the body’s own immune system to protect against dangerous pathogens to build immunity to that disease. Immunity means that the body has an existing defense system specific to a disease that protects a person from getting sick if they come into contact with that disease. According to the World Health Organization, vaccines have been estimated to have saved at least 10 million lives between 2010 and 2015 alone.

For the vast majority of individuals, vaccines have been shown to be safe and effective. This is a key component to why vaccinating as much of the population as possible is crucial for the operability of vaccines in fighting infectious disease. Herd immunity, also referred to as community immunity, is when a largely vaccinated population (95% of a community for the most contagious of diseases) can actually suppress a disease to the point of eradication, which greatly protects the most vulnerable population who cannot receive vaccines because of age or medical condition that renders vaccines unsafe for that individual. For example, newborn babies are immune to many diseases because they have antibodies they got from their mothers. However, this immunity goes away during the first year of life. If an unvaccinated child is exposed to a disease germ, the child’s body may not be strong enough to fight the disease. Before vaccines, many children died from diseases that vaccines now prevent, such as whooping cough, measles, and polio. Those same germs exist today, but because babies are protected by vaccines, we do not see these diseases nearly as often.

• 1. Current Public Health Threats. Although vaccines have been an incredible success in protecting communities from some of the most dangerous communicable diseases, in recent years there has been an uptick in the number of measles cases across the U.S., including in California. Highly contagious viruses, like the measles, can be contracted by individuals traveling to regions where it has not been eliminated and bring it back to the U.S. When this occurs, vulnerable, unvaccinated individuals are at risk of contracting the disease. Measles is one of the most contagious communicable diseases, nine out of 10 susceptible individuals that come into contact with the measles will develop the disease. The last large outbreak of the measles in California was in 2014-2015 in the Disneyland outbreak. According to DPH, at least 131 California residents contracted the measles either at Disneyland or from contact with an individual who contracted the disease at Disneyland in December 2014 according to DPH. Those infected included approximately 45% unvaccinated individuals and approximately 43% individuals with unknown vaccination records, according to a Morbidity and Mortality Weekly Report published by the CDC. Since 2015, according to the data from the CDC, there has been a steady increase in identified measles cases nationwide. To date in 2019, the CDC has reported 1,022 new cases of the measles. In California, there have been 51 cases of the measles across the state. It is worthwhile to note that 40 of these cases were in adults. This is likely because adults born prior to the 1989 recommendation of a second dose of the measles vaccine (MMR), have less immunity and are left susceptible to the disease. Nevertheless, the contagiousness of the measles leaves infants and children that are not vaccinated at great risk for contracting the disease which can lead to hospitalization and even death. In the pre-vaccine era, according to the CDC, nearly all children contracted the measles before they were 15 years old and an estimated 48,000 children were hospitalized and 400 to500 children died from this disease annually. That is the detriment communities face if community immunity is insufficient.
  2. Immunization Requirements. All 50 states in the U.S. have enacted laws or regulations that require children to receive certain vaccines before they enter certain childcare facilities and/or school. Exceptions to these laws vary by state, and can include medical, religious, and/or philosophical objections. In California, where vaccine laws are some of the strictest in the nation, personal belief exemptions (PBEs) based on religious or philosophical objections are no longer permitted since the passage of SB 277. Two other states, West Virginia and Mississippi, have also passed laws to ban PBEs. Medical exemptions from a licensed physician, however, continue to be accepted in schools.

Current state law mandates immunization of school-aged children against 10 specific diseases as specified in 4) under existing law above. Each of the 10 diseases were added to California code through legislative action, after careful consideration of the public health risks of these diseases, costs to the state and health system, communicability, and rates of transmission. All of the diseases for which California requires school vaccinations are serious conditions that pose very real health risks to children. Most of the diseases can be spread by contact with other infected children. Tetanus does not spread from student to student, but because it is such a serious potentially fatal disease, and it is easily preventable by vaccine, it is a required vaccination for school enrollment in children.

• 1. California Immunization Status Report 2018-2019. California schools are required to annually submit to DPH a report of the immunization status of their students. According to the 2018-2019 Kindergarten Immunization Assessment report published by the DPH Immunization Branch, 94.8% of all children entering kindergarten for the 2018-2019 school year were up to date and on time with all of the required immunizations. This is a 0.3% decrease in the immunization rate from the previous year. However, approximately 20% of schools and institutions have been identified to have immunization rates under 95%. These include day care centers (2,031/9,212 institutions), kindergartens (1,548/6,758 schools) and middle schools (331/3,362 schools) that have an immunization rate less of than 95%.

Although schools or institutions are required to report the immunization status of their students to DPH at least annually, in 2018-2019, there were approximately 1,000 schools and institutions that did not comply with this requirement.

In 2018 a group of researchers published two peer-reviewed articles (one in the journal Pediatrics and the other in the Journal of Research and Practice) detailing the experiences of LHOs and immunization staff in addressing medical exemptions after the passage of SB 277. One of the major concerns raised by these groups identified by the studies was the lack of a centralized review of medical exemptions. The LHOs and immunization staff interviewed (representing 35/61 local health departments) identified that the medical exemptions their jurisdictions received being accepted were, from their perspectives, problematic and not always consistent with trusted guidelines for immunization practices, including the CDC, ACIP, and AAP guidelines referenced in this bill.

• 1. MBC Investigation. Following the implementation of SB 277, there was, as reported above, an increase in medical exemptions in California. According to the MBC, since the passage of SB 277, there have been 173 confirmed complaints against 66 physicians regarding suspect medical exemptions according to the MBC. Additionally, there are 104 pending complaints among 52 physicians. The MBC has taken action against one physician. However, the MBC states that the investigations into complaints related to immunization standard of care, have been dismissed because of insufficient evidence, since patients that received the medical exemptions do not provide authorization of their medical exemption that are necessary to support the MBC’s accusation.
  2. Best Practice Guidelines for Administering Vaccines. The CDC, in coordination with the recommendations from ACIP, publishes the best practice guidelines for immunization schedules and for medical exemption decisions, including guidance on appropriate contraindications or precautions to administering vaccines. The ACIP is a committee of medical and public health experts that develop public health and safety-based recommendations on the public use of vaccines and related biological products. The ACIP includes 15 voting members responsible for making vaccine recommendations. The Secretary of the U.S. Department of Health and Human Services (DHHS) selects these members following an application and nomination process. Fourteen of the members have expertise in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and/or preventive medicine; one member is a consumer representative who provides perspectives on the social and community aspects of vaccination. In addition to the 15 voting members, ACIP includes eight ex officio members who represent other federal agencies with responsibility for immunization programs in the United States, and 30 non-voting representatives of liaison organizations that bring related immunization expertise. Professional organizations work with ACIP to develop the annual childhood and adult schedules. These organizations include the AAP, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the American College of Physicians. The 2019 Recommended Immunization Schedules for Persons Aged zero through 18 Years state: “children under six are recommended to receive vaccines for: hepatitis b; rotavirus; diphtheria, tetanus, and pertussis (DTaP); Hib; pneumococcal; polio; influenza; MMR; varicella; hepatitis a; and meningococcal.”
  3. Public Vaccine Safety Concerns: Safety studies, both throughout the Federal Drug Administration (FDA) drug trials process, and in ongoing studies show that vaccines are safe for the vast majority of the population. In California, 95.1% of all school-aged children have their full course of vaccination completed according to the CDC recommended schedule. As with all drugs, vaccines do not come without any side effects. The mild, acute reactions to vaccines include injection site redness, soreness, and a fever. These reactions have not been found to lead to any long term detriment. More severe reactions, such as encephalopathy and severe allergic reactions are considered valid contraindications of vaccines under CDC/ACIP/AAP guidelines. In addition to the antigen, or microbe specific to the disease a vaccine protects against, vaccines also include a number of other ingredients. The vaccine ingredient that causes much of the concerns or vaccine hesitancy are the adjuvants.

According to the FDA, for over 70 years, adjuvants have been components of non-live vaccines that stimulate the body to protect again the antigen being injected as part of the vaccine. Alum, or aluminum salts are the most commonly used adjuvants in the U.S. for vaccines, and illicit a defense immune response against the antigen (disease microbe). The use of adjuvants allows less antigen to be used in the vaccine and also allows vaccines to be safe and effective for immunocompromised individuals. This is why in the CDC/ACIP/AAP best practice guidelines, only live vaccines such as MMR and Varicella, are contraindicated for individuals without sufficient immunocompetence. The National Institutes for Health branch National Institute of Allergy and Infectious Disease, in 2018, refined and published their research goals for a Strategic Plan for Research on Vaccine Adjuvants, which include improving the efficacy and understanding of long-term safety of existing and novel adjuvants used in vaccines.

• 1. Federal Vaccine Injury Programs.
     1. Vaccine Adverse Event Reporting System (VAERS). The CDC and FDA run VAERS, a national surveillance program to detect possible safety issues with U.S. vaccines by collecting information related to adverse events and side effects that occur after vaccination. VAERS was created in 1990 as part of the National Childhood Vaccine Injury Act. The major goals of this reporting system are to monitor vaccine reactions and to apply that knowledge to assess the safety of vaccines while monitoring public health emergencies relating to vaccines. Anyone may submit their adverse reactions to this program.
     2. The National Vaccine Injury Compensation Program (NVICP). NVICP was established in the 1980s after lawsuits against vaccine companies and health care providers threatened to cause vaccine shortages and reduce U.S. vaccination rates. A consequence of vaccine shortages could have been a resurgence of vaccine preventable diseases. NVCIP is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions and is paid for by vaccine manufacturers through a $0.75 per dose tax.

NVICP permits any individual who received a covered vaccine and believes they were injured as a result, to file a petition. Parents, legal guardians and legal representatives are permitted to file on behalf of children, disabled adults, and individuals who are deceased.

To get compensation, an individual must file a petition with the U.S. Court of Federal Claims. DHHS medical staff reviews the petition, determines if it meets the medical criteria for compensation and makes a preliminary recommendation. The U.S. Department of Justice develops a report that includes the medical recommendation and legal analysis and submits it to the Court. The report is presented to a court-appointed special master, who decides whether the petitioner should be compensated, often after holding a hearing in which both parties can present evidence. If compensation is awarded, the special master determines the amount and type of compensation. The Court then orders DHHS to award compensation. Even if the petition is dismissed, if certain requirements are met, the Court can order DHHS to pay attorneys' fees and costs. The special master's decision may be appealed and petitioners who reject the decision of the court (or withdraw their petitions within certain timelines) may file a claim in civil court against the vaccine company and/or the health care provider who administered the vaccine. This process takes about two to three years to complete.

According to a NVICP compensation report updated on June 1, 2019, from 2006 to 2017 over 3.4 billion doses of covered vaccines were distributed in the U.S. For petitions filed in this time period, 6,314 petitions were adjudicated by the Court, and of those 4,328 were compensated. This means for every 1 million doses of vaccine that were distributed, approximately 1 individual was compensated. Since 1988, over 20,728 petitions have been filed with the NVICP. Over that 30-year time period, 17,923 petitions have been adjudicated, with 6,597 of those determined to be compensable, while 11,326 were dismissed. Total compensation paid over the life of the program is approximately $4.1 billion.

1. Major Provisions of this Bill:
   1. Standardized Medical Exemption Form. This bill requires DPH to develop a standardized form for medical exemptions. This form must include the following information:
      1. Physician Information. Name and California medical license number, business address and telephone number, of the PCP and the physician issuing the medical exemption;
      2. Child Information. Name of the child, and the name and address of the child’s parents or guardians;
      3. Physical examination and evaluation. A statement certifying that the issuing physician physically examined and evaluated the child according to standards of care;
      4. PCP. Whether the issuing physician is the child’s PCP. If the physician issuing the medical exemption has not been treating the child for at least one year, then the issuing physician must attest that the PCP has been contacted and advised of the submission of the medical exemption;
      5. Medical reason. A description of the medical reason for which the medical exemption is sought. The form must have space for each specific, required immunization;
      6. Permanent or temporary. Whether the medical exemption is permanent or temporary. For temporary medical exemptions, the form must also include the duration, specified to be up to one year, of the exemption;
      7. Authorization. An authorization for the release of medical records related to the medical exemption to the DPH, the MBC, and OMB;
      8. Penalty of Perjury. The physician issuing the form must certify under penalty of law that the information included on the form is accurate; and,
      9. Form fee. The physician is prohibited from charging a fee for filling out the medical exemption and for follow up examinations regarding temporary exemptions.
   2. Review of Medical Exemptions Obtained On or After January 1, 2021.
      1. This bill requires DPH to annually review immunization reports from all schools and institutions and identify those that are subject to review. A clinically trained immunization staff from DPH shall review all medical exemptions from CAIR under either of the following circumstances:
         1. Schools or institutions which are found to have an immunization rate of less than 95%; or,
         2. Physicians and surgeons who have submitted five or more medical exemptions annually.
            
      2. There are two criteria established for the review, as follows:
         1. DPH will identify those medical exemption forms that do not meet applicable CDC, ACIP, or AAP criteria for appropriate medical exemptions. DPH may contact the PCP or issuing physician to request additional information to support the medical exemption.
         2. DPH, based on the medical discretion of the clinically trained immunization staff member, may accept a medical exemption that is based on other contraindications or precautions, including consideration of family medical history, if the issuing physician provides written documentation to support the medical exemption that is consistent with the relevant standard of care.
            
            If a medical exemption is determined under either of the above circumstances as inappropriate or invalid, the SPHO or physician designee will also review these exemptions to determine whether to deny or revoke a medical exemption.
   3. Notification. If a medical exemption is denied or revoked, DPH must notify the issuing physician, school or institution and the LHO where the school is located of this denial or revocation;
   4. Conditional Admission. Consistent with existing regulations, if a medical exemption is denied or revoked, a child must comply with the conditional admission schedule for immunizations and continued attendance requirements specified in existing regulations;
   5. Prohibition on issuing medical exemptions for two years. This bill prohibits DPH from accepting medical exemptions from physicians under one or both of the following circumstances:
      1. If DPH determines that a physician poses a risk to the public’s health in one or more communities until the physician demonstrates to DPH that the risk no longer exist, but in no event should DPH accept medical exemptions from this physician and surgeon for at least two years; and,
      2. If there is a pending accusation against a physician with the MBC or OMB relating to immunization standards of care until the accusation is resolved in favor of the physician.
   6. Appeals. This bill permits a medical exemption denied or revoked, as specified, to be appealed by a parent or guardian to the Secretary CHHS. Allows parents or guardians to provide necessary information to the independent expert review panel for purposes of the appeal. The appeals process is as follows:
      1. The CHHS Secretary is required to appoint an independent panel of experts to hear the appeal. The panel must consist of three clinically licensed physicians that are PCPs or immunization experts. CHHS must establish requirements, including conflict of interest standards that the three panelist must meet in order to qualify for an appointment to the panel;
      2. The independent review panel is required to evaluate appeals consistent with CDC/ACIP guidelines and the relevant standard of care as applicable;
      3. The independent expert review panel will submit its findings and recommendations to the CHHS Secretary; and,
      4. The CHHS Secretary’s final decision will be consistent with the findings of the independent expert review panel and is not subject to further administrative review.
   7. Medical exemptions issued before January 1, 2021. This bill requires parents and guardians with medical exemptions issued prior to the creation of the standardized medical exemption certification form to submit their existing medical exemptions to DPH to be included in CAIR. This bill does not require DPH to review medical exemptions obtained prior to January 1, 2021, however, it does permit review of these medical exemptions.
   8. Public Health. This bill permits DPH to review any exemption in CAIR as necessary to protect public health.
2. SUPPORT. According to one of the sponsors of this bill, the California Medical Association (CMA), high levels of immunization are necessary to, through a process called “community immunity,” protect those who are unable to be immunized against vaccine-preventable illness. Given the highly contagious nature of diseases such as measles, vaccination rates of up to 95% are necessary. CMA states that since the passage of SB 277, the use of medical exemptions has more than tripled, putting many communities below the required protective immunization level.

The AAP, a cosponsor of this bill, states that this bill would create a partnership between state public health, schools and doctors to help keep children safe at school and to protect vulnerable community members, including babies too young to be immunized and people who are immunocompromised, from the risks associated with contracting these diseases. It would also protect the community at large from outbreaks of vaccine-preventable disease.

1. OPPOSITION. According to the National Vaccine Information Center (NVIC), it is inappropriate for DPH, a state agency, to be given legal authority to hijack the private patient physician relationship by being placed in the position to reject doctor issued medical vaccine exemptions. Confining vaccine exemptions to narrow and incomplete CDC guidelines hurts children. NVIC states that forcing physicians to violate their professional judgment and their conscience is a form of state-sponsored tyranny that should not be part of public health law in any state.

Advocates for Physicians’ Rights (APR), another organization opposed to this bill states that the CDC guidelines generally do not recognize family health history of allergic reactions or side effects as a valid reason upon which to base a medical exemption (and the only time they do recognize such is for altered immuno-incompetence in relation to MMR and Varicella). APR concludes that this runs counter to long-accepted medical standards of care, which recognize family history as a strong predictor of medical outcomes, and will negate physicians’ clinical judgment regarding statistically-likely harm to members of a family that share the same gene pool.

1. PREVIOUS LEGISLATION.
   1. SB 277 eliminated the personal belief exemption from the requirement that children receive vaccines for certain infectious diseases prior to being admitted to any public or private elementary or secondary school or day care center.
   2. SB 2109 (Pan), Chapter 821, Statutes of 2012, requires a separate form prescribed by DPH to accompany a letter or affidavit to exempt a child from immunization requirements under existing law on the basis that an immunization is contrary to beliefs of the child’s parent or guardian.
   3. AB 2064 (V. Manuel Pérez) of 2012, would have required a health care service plan or health insurer that provides coverage for childhood and adolescent immunizations to reimburse a physician or physician group in an amount not less than the actual cost of acquiring the vaccine plus the cost of administration of the vaccine. AB 2064 was held in the Assembly Appropriations Committee on the suspense file.
   4. SB 614 (Kehoe), Chapter 123, Statutes of 2011, allowed a pupil in grades seven through 12, to conditionally attend school for up to 30 calendar days beyond the pupil’s first day of attendance for the 2011-12 school year, if that pupil has not been fully immunized with all pertussis boosters appropriate for the pupil’s age if specified conditions are met.
   5. AB 354 (Arambula), Chapter 434, Statutes of 2010, allows DPH to update vaccination requirements for children entering schools and child care facilities and adds the American Academy of Family Physicians to the list of entities whose recommendations DPH must consider when updating the list of required vaccinations. Required children entering grades 7 through 12 receive a TDaP booster prior to admittance to school.
   6. AB 1201 (V. Manuel Pérez) of 2009, would have required a health care service plan or health insurer that provides coverage for childhood and adolescent immunizations to reimburse a physician or physician group the entire cost of acquiring and administering the vaccine, and prohibits a health plan or insurer from requiring cost-sharing for immunizations. AB 1202 was held on the Assembly Appropriations Committee suspense file.
   7. SB 1179 (Aanestad) of 2008, would have deleted DPH’s authority to add diseases to the list of those requiring immunizations prior to entry to any private or public elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center. SB 1179 died in the Senate Health Committee.
   8. AB 2580 (Arambula) of 2008, would have required pupils entering the seventh grade to be fully immunized against pertussis by receiving any necessary adolescent booster immunization. AB 2580 was held on the Senate Appropriations Committee suspense file.
   9. SB 676 (Ridley-Thomas) of 2007, would have required pupils entering the seventh grade to be fully immunized against pertussis. SB 676 was held on suspense in Assembly Appropriations Committee.
   10. SB 533 (Yee) of 2007, would have added pneumococcus to the list of diseases that pupils are required to be immunized against before entry into any private or public elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center, except for children who are 24 months of age or older. SB 533 was vetoed by the Governor.
   11. SB 574 (Wolk), Chapter 329, Statutes of 2005, authorized the creation of an immunization information system, a system that is currently known as the California Immunization Registry that is overseen by DPH.
2. PROPOSED AMENDMENTS. The Committee recommends the following amendments:
3. Clarify that if the issuing physician is not the child’s PCP, the issuing physician must also provide an explanation on why the issuing physician and not the PCP is filling out the medical exemption form.
4. Require the form to include how long the physician has been treating the child.
5. Clarify attendance requirements for students whose medical exemptions are revoked or whose medical exemption is pending appeal.
6. Clarify the limitation on charging for examination related to temporary medical exemption.
7. Clarify the requirement for DPH to notify the MBC or OMB when a physician submits five or more medical exemptions forms in a school year that are revoked.
8. Delete the authorization for the LHO to determine if a medical exemption granted prior to January 1, 2021 is fraudulent or inconsistent with CDC criteria, as specified, and instead require DPH to review medical forms submitted prior to January 1, 2021 if: the school or institution has 95% overall immunization rate, or the physician has submitted five or more medical exemptions in a calendar year.
9. Require DPH to clearly establish and communicate the process for the review of medical exemptions conducted under this bill.
10. Require DPH to review school or institutions that do not submit immunization reports or medical exemption forms to DPH.
11. Require DPH to also notify the parent or guardian if a medical exemption is revoked.
12. Require the DHHS to establish process and guidelines for the appeal process.
13. Clarify that the physicians who serve on the independent expert review panel have relevant knowledge, training or experience relating to primary care or immunization.
14. Makes other, technical and conforming changes.

REGISTERED SUPPORT / OPPOSITION:

Support

California Medical Association (cosponsor)

American Academy of Pediatrics, California (cosponsor)

Vaccinate California (cosponsor)

AIDS Healthcare Foundation

American College of Physicians - California Chapter

California Academy of Eye Physicians & Surgeons
California Academy of Family Physicians

California Academy of Pain Medicine

California Academy of Preventive Medicine

California Association of Hospitals and Health Systems

California Chapter American College of Cardiology
California Children's Hospital Association
California Hospital Association

California Life Sciences Association

California Medical Association
California Optometric Association
California Orthopedic Association

California School Nurses Organization
California Society for Allergy, Asthma and Immunology

California Society of Health System Pharmacists

California Society of Physical Medicine and Rehabilitation

California State Association of Counties
California State PTA

Children Now
Children's Defense Fund-California
Children's Specialty Care Coalition
County Health Executives Association of California
County of Los Angeles Board Of Supervisors

County of Marin

County of Santa Clara
Donate Life California

Health Officers Association of California
Infectious Disease Association of California

Kaiser Permanente
LA Care Health Plan

March of Dimes
Parent's For Choice

Sonoma County Health Action Committee for Healthcare Improvement

Sutter Health

Vaccinate California

Opposition

A Voice For Choice Advocacy
Advocates For Physicians' Rights
Alliance For Natural Health USA
Amy's Chocolate
Animal Wellness & Veterinary Pain Management, Inc.
Association of American Physicians And Surgeons
Autism International Association, Inc
Breathe Bodyworks Holistic Healing Network
California Health Coalition Advocacy
California Right To Life Committee, Inc.

Californians for Trusted Healthcare

Children’s Health Coalition
Concerned Physicians Opposed to SB 276
Drjockers.Com
Eagle Forum of California
Educate.Advocate

Families For Early Autism Treatment
Matrix Mothers
Moms Across America
National Health Freedom Action
National Vaccine Information Center
Orange County Health Choice
Parentalrights.Org
Parents United 4 Kids
Physicians Association For Anthroposophical Medicine
Physicians for Informed Consent
Progressives for Choice
Raphael Medicine & Therapies Pc
SCV For Parental Rights
U Turn For Christ
Vaccine-Injury Awareness League
West Coast Elite Dance
West Virginians For Health Freedom

Numerous Individuals

Analysis Prepared by: Marissa Kraynak, Ph.D. / HEALTH / (916) 319-2097

 THIRD READING  

Bill No: SB 276

Author: Pan (D), et al.

Amended: 5/17/19

Vote: 21

SENATE HEALTH COMMITTEE: 7-2, 4/24/19

AYES: Pan, Durazo, Hurtado, Leyva, Mitchell, Monning, Rubio

NOES: Stone, Grove

SENATE APPROPRIATIONS COMMITTEE: 4-2, 5/16/19

AYES: Portantino, Bradford, Hill, Wieckowski

NOES: Bates, Jones

SUBJECT: Immunizations: medical exemptions

SOURCE: American Academy of Pediatrics, California

California Medical Association

Vaccinate California

DIGEST:

1. This bill requires the Department of Public Health (DPH) to develop a statewide standardized medical exemption request form for immunization requirements in existing law. This bill requires DPH to make the request form available for use by physicians. This bill requires the request form to be the only medical exemption documentation that a governing authority may accept. This bill requires a request form to be approved or denied only by the State Public Health Officer (PHO), upon a determination that the request provides sufficient medical evidence that the immunization is contraindicated by guidelines of the Centers for Disease Control and Prevention (CDC). This bill requires DPH to create and maintain a database of approved medical exemption requests. This bill requires DPH to make the information in the database accessible to local public health officers.

ANALYSIS:

Existing law:

1. Requires DPH to examine the causes of communicable disease in man and domestic animals occurring or likely to occur in this state. [HSC §120125]
2. Gives the PHO, as the Director of DPH, broad authority to detect, monitor, and prevent the spread of communicable disease in the state, including the ability to:
   1. Require reporting of communicable disease that DPH identifies, on timelines and in a manner determined by DPH;
   2. Adopt and enforce regulations requiring strict or modified isolation, or quarantine, for any of the contagious, infectious, or communicable diseases, if in the opinion of DPH, the action is necessary for the protection of the public health;
   3. Take measures as are necessary to ascertain the nature of the disease and prevent its spread. Permits DPH, to that end, if it considers it proper, to take possession or control of the body of any living person, or the corpse of any deceased person;
   4. Quarantine, isolate, inspect, and disinfect persons, animals, houses, rooms, other property, places, cities, or localities, whenever in its judgment the action is necessary to protect or preserve the public health; and,
   5. Destroy such objects as bedding, carpets, household goods, furnishings, materials, clothing, or animals, when ordinary means of disinfection are considered unsafe, and when the property is in its judgment, an imminent menace to the public health. [HSC §120130, et seq.]
3. Requires a local health officer (LHO) knowing or having reason to believe that any case of reportable diseases, or any other contagious, infectious or communicable disease exists, or has recently existed, within the territory under his or her jurisdiction, to take measures as may be necessary to prevent the spread of the disease or occurrence of additional cases. [HSC §120175]
4. Prohibits the governing authority of a school or other institution from unconditionally admitting any person as a pupil of any private or public elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center, unless, prior to his or her first admission to that institution, he or she has been fully immunized against diphtheria, haemophilus influenzae type b (Hib), measles, mumps, pertussis, poliomyelitis, rubella, tetanus, hepatitis b (except after 7th grade), and chickenpox, as specified. [HSC §120335]
5. Permits DPH to add to this list any other disease deemed appropriate, taking into consideration the recommendations of the CDC Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics Committee on Infectious Diseases. [HSC §120335]
6. Waives the above immunization requirements if the parent or guardian files with the governing authority a written statement by a licensed physician to the effect that the physical condition of the child is such, or medical circumstances relating to the child are such, that immunization is not considered safe, indicating the specific nature and probable duration of the medical condition or circumstances including, but not limited to, family medical history, for which the physician does not recommend immunization. [HSC §120370(a)]
7. Permits a child for whom the requirement has been waived, if there is good cause to believe that a child has been exposed to one of the specified communicable diseases and the child’s proof of immunization status does not show proof of immunization against that disease, to be temporarily excluded from the school or institution until the LHO is satisfied that the child is no longer at risk of developing or transmitting the disease. [HSC §120370(b)]

This bill:

1. Requires DPH to develop a statewide standardized medical exemption request form by July 1, 2020. Requires DPH to make the request form available for use by physicians. Requires the request form to be the only medical exemption documentation that a governing authority may accept after January 1, 2021.
2. Requires a request form to be approved or denied only by the PHO or his/her designee, upon a determination that the request provides sufficient medical evidence that the immunization is contraindicated or there exists a specific precaution regarding an immunization based on CDC guidelines.
3. Requires the request form to require, at a minimum: the physician’s name, medical license number, business address, and telephone number; the name of the child for whom the exemption is sought and the name of the child’s parent or guardian; a statement certifying that the physician has personally examined the child; a description of the medical reason for which the exemption is required; and, an authorization for the release of records related to the medical exemption by the physician to DPH and the Medical Board of California.
4. Requires a physician, after January 1, 2021, if a parent or guardian requests a medical exemption for a child, to inform the parent or guardian of the requirements of this bill. Requires the physician, if the parent or guardian consents, to examine the child and submit a completed request form to DPH. Permits medical exemption request forms to be submitted to DPH at any time.
5. Requires the PHO or his/her designee to review the completed request form and provide the physician with notification approving or denying the medical exemption request. Requires the reason for the denial, if the medical exemption request is denied, to be included in the notification.
6. Permits a denial of a request for a medical exemption to be appealed to the PHO. Permits the physician to submit additional information to DPH within 30 days from the notification for further review by the PHO or his/her designee.
7. Requires DPH, by December 31, 2020, to create and maintain a database of approved medical exemption requests. Requires DPH to make the information in the database accessible to local PHOs.
8. Requires a parent or guardian, if a medical exemption has been authorized under 5) of existing law above prior to the adoption of the statewide standardized medical exemption request form, to submit a copy of that medical exemption to DPH by December 31, 2020, for inclusion in the database in order for the medical exemption to remain valid.
9. Permits the PHO or a LHO to revoke a medical exemption if he/she determines that a medical exemption is fraudulent or inconsistent with applicable CDC guidelines.
10. Requires DPH, in consultation with local educational agencies and local public health officers, to develop a process for a parent or guardian to request a medical exemption and to expeditiously approve or deny the request and communicate its decision in a timely manner to the school district and the parent or guardian.
11. Requires DPH to comply with all applicable state and federal privacy laws, as specified, in implementing this bill.
12. Prohibits this bill from being construed to require DPH to review or approve any medical exemption granted prior to January 1, 2021.

Comments

1. Author’s statement. According to the author, in the first four months of 2019, 465 measles cases have been reported across 19 states, a number far surpassing last year’s number of cases. Since elimination of measles in the U.S. in 2000, this is the second greatest number of cases reported. SB 277 (Pan and Allen, Chapter 35, Statutes of 2015) eliminated all non-medical exemptions for immunizations required for school entry. While SB 277 was successful in raising immunization rates, the number of medical exemptions issued more than tripled since the law went into effect. Many of the exemptions are clustered in the same schools, creating concentrated pockets of unvaccinated individuals. At almost 60 schools in the state, more than 10% of kindergarteners had medical exemptions. According to PHO, the rise in medical exemptions is associated with an increase in physicians issuing exemptions for children without medically-justified contraindications. While the vast majority of physicians uphold standards of care, a small number of unethical physicians have monetized their license by selling medical exemptions for profit. Currently, California law requires no state-level oversight or standardization of exemptions. As a result, medical exemptions often contain incomplete information and may be issued for reasons other than medically-justified contraindications. This bill will restore integrity to California’s exemption process.
2. Immunizations. According to the World Health Organization, immunization is the process whereby a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine. Vaccines stimulate the body’s own immune system to protect the person against subsequent infection or disease. Immunization is a proven tool for controlling and eliminating life-threatening infectious diseases and is estimated to avert between two and three million deaths each year. It is one of the most cost-effective health investments, with proven strategies that make it accessible to even the most hard-to-reach and vulnerable populations. It has clearly defined target groups; it can be delivered effectively through outreach activities; and vaccination does not require any major lifestyle change.
3. ACIP. According to ACIP, it includes 15 voting members responsible for making vaccine recommendations. ACIP also includes eight ex officio members who represent other federal agencies with responsibility for immunization programs in the United States, and 30 non-voting representatives of liaison organizations that bring related immunization expertise. The overall goals of ACIP are to provide advice to assist in reducing the incidence of vaccine-preventable diseases and to increase the safe usage of vaccines and related biological products. The 2019 Recommended Immunization Schedules for Persons Aged 0 Through 18 Years state: children under six are recommended to receive vaccines for: hepatitis b; rotavirus; diphtheria, tetanus, and pertussis (DTaP); Hib; pneumococcal; polio; influenza; measles, mumps, rubella (MMR); varicella; hepatitis a; and meningococcal.
4. Exemptions to vaccine requirements. There are two types of non-medical exemptions states have incorporated into requirements that children be vaccinated before entering school: religious exemptions and philosophical exemptions. A religious exemption means that there is a provision in the statute that allows parents to exempt their children from vaccination if it contradicts their sincere religious beliefs. A philosophical exemption means that the statutory language does not restrict the exemption to purely religious or spiritual beliefs. According to the National Conference of State Legislatures, all 50 states have laws requiring specified vaccines for students. Although exemptions vary from state to state, all school immunization laws grant exemptions to children for medical reasons. Almost all states grant religious exemptions for people who have religious beliefs against immunizations. California, Mississippi, and West Virginia allow only medical exemptions. Currently, 17 states allow philosophical exemptions for those who object to immunizations because of personal, moral or other beliefs.
5. Contraindications and precautions. According to the CDC’s General Best Practice Guidelines for Immunization: Contraindications and Precautions, contraindications (conditions in a patient that increases the risk for a serious adverse reaction) and precautions to vaccination are conditions under which vaccines should not be administered. Because the majority of contraindications and precautions are temporary, vaccinations often can be administered later when the condition leading to a contraindication or precaution no longer exists. One example of a contraindication is that severely immunocompromised persons generally should not receive live vaccines. Because of the theoretical risk to the fetus, pregnant women generally should not receive live, attenuated virus vaccines. A precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the ability of the vaccine to produce immunity. A person might experience a more severe reaction to the vaccine than would have otherwise been expected; however, the risk for this happening is less than the risk expected with a contraindication. In general, vaccinations should be deferred when a precaution is present. However, a vaccination might be indicated in the presence of a precaution if the benefit of protection from the vaccine outweighs the risk for an adverse reaction. As an example, the presence of a moderate or severe acute illness is a precaution to administration of all vaccines. The decision to administer or delay vaccination depends on the severity of symptoms and cause of the condition. According to the Guidelines, screening for contraindications, persons with moderate or severe acute illness should be vaccinated as soon as the illness has improved.
6. California vaccination rates. According to DPH’s 2017-18 Kindergarten Immunization Assessment, 2017-2018 is the second full school year that entrants were subject to SB 277, which eliminated personal beliefs exemptions from immunization requirements. The proportion of students attending kindergarten in 2017-2018 reported to have received all required vaccines is 95.1%, a 0.4 percentage point decrease from the 2016-2017 school year and a 4.7 percentage point increase over the three years since 2014-2015. Compared to 2016-2017, in 2017-2018 the proportion of kindergartners reported as:
   1. Having permanent medical exemptions increased from 0.5% to 0.7%;
   2. Lacking immunizations for other reasons specified under SB 277 increased from 0.5% to 1.1%, with 0.8% reported as being enrolled in independent study programs; and,
   3. Being overdue for required immunizations increased from 1.0% to 1.2%.
7. California measles outbreak. SB 277 was, in part, prompted by a December 2014 a measles outbreak that began in Disneyland (Orange County) and resulted in 134 confirmed measles cases. Of the confirmed cases: 40 cases visited Disneyland between December 17 and December 20 where they are presumed to have been exposed to measles; 30 are household or close contacts to a confirmed case; 11 were exposed in a community setting (e.g., emergency room) where a confirmed case was known to be present; 50 have an unknown exposure source but are presumed to be linked to the outbreak based on a combination of descriptive epidemiology or strain type; and, three cases are known to have a different genotype from the outbreak strain. The ages of those infected with the measles during this outbreak varied, with 56% being 20 years or older, 18% were between the ages of five and 19, 15% were ages one to four, and 11% were under the age of one. Among measles cases for whom DPH have vaccination documentation, 57 were unvaccinated and 25 had one or more doses of MMR vaccine.
8. 2019 outbreaks. According to the CDC, from January 1 to April 19, 2019, 626 individual cases of measles have been confirmed in 19 states. This is the second-greatest number of cases reported in the U.S. since measles was eliminated in 2000. The states that have reported cases to CDC are Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, Nevada, New Hampshire, New Jersey, New York, Oregon, Texas, and Washington. Two outbreaks have been highly publicized in the news: Washington and New York. In Clark County, Washington, there have been 73 confirmed cases since January 1. Of these cases, 53 were age one to ten years, 15 cases were 11 to 18 years, one case was 19 to 29 years, and four cases were 30 to 39 years. Sixty three infected individuals were unimmunized. In New York City, as of April 18, 2019, there have been 359 confirmed cases of measles in Brooklyn and Queens since October. According to the city’s health department, most of these cases have involved members of the Orthodox Jewish community. The initial child with measles was unvaccinated and acquired the disease on a visit to Israel, where a large outbreak is occurring. Since then, there have been additional people from Brooklyn and Queens who were unvaccinated and acquired measles while in Israel. People who did not travel were also infected in Brooklyn or Rockland County. On April 9, the Health Commissioner ordered every adult and child who lives, works or resides in the certain ZIP codes and has not received the MMR vaccine to be vaccinated or face a fine of $1,000.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

According to the Senate Appropriations Committee, up to $9.4 million in FY 2019-20; $9.97 million in FY 2020-21; $10.8 million in FY 2021-22; $10.2 million in FY 2022-23, and $10.15 million in FY 2023-24. All costs to be borne by General Fund for DPH workload and staff to promulgate regulations, prepare appeals, and review exemption requests. In addition, staff anticipates possible contract costs, and ongoing operations costs, for the development and maintenance of a database and its security.

SUPPORT: (Verified 5/16/19)

American Academy of Pediatrics, California (co-source)

California Medical Association (co-source)

Vaccinate California (co-source)

Advanced Medical Technology Association

AIDS Healthcare Foundation

American College of Cardiology, California Chapter

American College of Physicians, California Chapter

Bikur Cholim Jewish Healthcare Foundation

California Academy of Eye Physicians and Surgeons

California Academy of Family Physicians

California Academy of Pain Medicine

California Association of Professional Scientists

California Chapter American College of Cardiology

California Children’s Hospital Association

California Hospital Association

California Immunization Coalition

California Life Sciences Association

California Optometric Association

California Orthopaedic Association

California School Nurses Organization

California Society for Asthma, Allergy, and Immunology

California Society of Health-System Pharmacists

California State Association of Counties

CHEAC – Improving the Health of all Californians

Children Now

Children’s Defense Fund

Children’s Specialty Care Coalition

County Health Executives Association of California

County of Los Angeles, Board of Supervisors

County of Marin

Donate Life California

Health Officers Association of California

Infectious Disease Association of California

Kaiser Permanente

LA Care Health Plan

March of Dimes

Orthopedic Surgery Specialists Medical Group

Providence St. Joseph Health

Over 700 individuals

OPPOSITION: (Verified 5/16/19)

A Voice for Choice Advocacy

Alliance for Natural Health USA

Association of American Physicians and Surgeons

California Health Coalition Advocacy

California Right to Life Committee, Inc.

Californians for Trusted Healthcare

Eagle Forum of California

Educate.Advocate.

Moms Across America

National Health Freedom Action

National Vaccine Information Center

ParentalRights.org

Physicians for Informed Consent

Physicians’ Association for Anthroposophic Medicine

Vaccine-Injury Awareness League

West Virginians for Health Freedom

Over 800 individuals

Prepared by: Melanie Moreno / HEALTH / (916) 651-4111

5/20/19 13:37:49

**** END ****

SENATE COMMITTEE ON APPROPRIATIONS

Senator Anthony Portantino, Chair

2019 - 2020 Regular Session

SB 276 (Pan) - Immunizations: medical exemptions

Bill Summary:

Senate Bill 276 would require, by July 1, 2020, the Department of Public Health (CDPH) to develop, and make available, a statewide standardized medical exemption request form to physicians and surgeons. Would require the State Public Health Officer, or designee, to approve or deny a medical exemption request. Would require CDPH, by December 31, 2020, to create and maintain a database of approved medical exemption requests.

*********** ANALYSIS ADDENDUM – SUSPENSE FILE ***********

The following information is revised to reflect amendments

adopted by the committee on May 16, 2019

Fiscal Impact:

Up to $9.4 million in FY 2019-20; $9.97 million in FY 2020-21; $10.8 million in FY 2021-22; $10.2 million in FY 2022-23, and $10.15 million in FY 2023-24. All costs to be borne by General Fund for CDPH workload and staff to promulgate regulations, prepare appeals, and review exemption requests. In addition, staff anticipates possible contract costs, and ongoing operations costs, for the development and maintenance of a database and its security.

Author Amendments:

The author amendments would:

• Clarify the medical exemption request form may be submitted to CDPH at any time.
• Add to the list of required components form must include an authorization for the release of records related to the medical exemption by the physician and surgeon to the CDPH and the Medical Board of California.
• Provide that nothing in the bill’s provisions, related to the standardized medical exemption request form, can be construed to require CDPH to review or approve any medical exemption granted by a physician or surgeon prior to January 1, 2021.

-- END --

SENATE COMMITTEE ON APPROPRIATIONS

Senator Anthony Portantino, Chair

2019 - 2020 Regular Session

SB 276 (Pan) - Immunizations: medical exemptions

Bill Summary:

Senate Bill 276 would require, by July 1, 2020, the Department of Public Health (CDPH) to develop, and make available, a statewide standardized medical exemption request form to physicians and surgeons. Would require the State Public Health Officer, or designee, to approve or deny a medical exemption request. Would require CDPH, by December 31, 2020, to create and maintain a database of approved medical exemption requests.

Fiscal Impact:

Up to $9.4 million in FY 2019-20; $9.97 million in FY 2020-21; $10.8 million in FY 2021-22; $10.2 million in FY 2022-23, and $10.15 million in FY 2023-24. All costs to be borne by General Fund for CDPH workload and staff to promulgate regulations, prepare appeals, and review exemption requests. In addition, staff anticipates possible contract costs, and ongoing operations costs, for the development and maintenance of a database and its security. CDPH assumes 11,500 medical exemptions and 3,500 temporary medical exemptions to be filed with the Department under SB276. There are 58,000 existing medical exemptions. CDPH will be required to review those exemptions to determine if they meet the criteria set forth in the bill.  These exemptions will not be under the same time constraint as the new exemptions and will be completed over a longer period of time.

Background:

1. Immunization is the process whereby a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine. Vaccines stimulate the body’s own immune system to protect the person against subsequent infection or disease. Immunization is a proven tool for controlling and eliminating life-threatening infectious diseases and is estimated to avert between two and three million deaths each year.

There are two types of non-medical exemptions states have incorporated into requirements that children be vaccinated before entering school: religious exemptions and philosophical exemptions. A religious exemption means that there is a provision in the statute that allows parents to exempt their children from vaccination if it contradicts their sincere religious beliefs. A philosophical exemption means that the statutory language does not restrict the exemption to purely religious or spiritual beliefs. The decision to administer or delay vaccination depends on the severity of symptoms and cause of the condition. According to the Guidelines, screening for contraindications, persons with moderate or severe acute illness should be vaccinated as soon as the illness has improved.

SB 277 was, in part, prompted by a December 2014, measles outbreak that began in Disneyland (Orange County) and resulted in 134 confirmed measles cases. SB 277 (Pan and Allen, Chapter 35, Statutes of 2015) eliminates the PBE from the requirement that children receive vaccines for certain infectious diseases prior to being admitted to any public or private elementary or secondary school or day care center. According to the Centers for Disease Control and Prevention, as of May 6, 2019, at least 764 cases across 23 states have been reported this year. 2019 marks the greatest number of cases since an outbreak from 1989 to 1991, which included more than 50,000 cases. According to DPH’s 2017-18 Kindergarten Immunization Assessment, each autumn California schools are required to report the status of their students under state immunization requirement laws. 2017-2018 is the second full school year that entrants have been subject to SB 277, which no longer permits them to receive personal beliefs exemptions from immunization requirements. The proportion of students attending kindergarten in 2017-2018 reported to have received all required vaccines is 95.1%, a 0.4 percentage point decrease from the 2016-2017 school year and a 4.7 percentage point increase over the three years since 2014-2015.

Proposed Law:

Senate Bill 276 would require, by July 1, 2020, the Department of Public Health (CDPH) to develop, and make available, a statewide standardized medical exemption request form to physicians and surgeons. Would require the State Public Health Officer, or designee, to approve or deny a medical exemption request. Would require CDPH, by December 31, 2020, to create and maintain a database of approved medical exemption requests.

Staff Comments:

Staff notes the bill’s language regarding exemptions granted prior to July 1, 2020, could be interpreted to mean that prior medical exemptions that would need to be submitted to the department would require the State Public Health Officer, or their designee, to review and determine that appropriateness of the exemption, or whether those exemptions are grandfathered. CDPH interprets the bill to mean that these exemptions would need to be reviewed to determine whether they meet the criteria set forth in the bill.

According to the CDPH:

CDPH believes that 5,000 medical exemptions and 500 temporary exemptions will not meet the criteria in currently in the bill. 

The first level of appeal is with the State Public Health Officer and this level of appeal allows the physician to provide additional information.  We expect all will be appealed at this level, and we expect there may be some overturned based on additional information, but this will likely be a low number.

The second level of appeal will be with an administrative law judge.  The fiscal assumes 25% appeal the SPHO decision. That accounts for the Attorney costs to prepare for the ALJ hearing.  Please note that the number of appeals may be much higher as there is no cost associated with this appeal.  We also assume that these appeals will need to be expedited to allow children to enter school.

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SENATE COMMITTEE ON HEALTH

Senator Dr. Richard Pan, Chair

BILL NO: SB 276

SUBJECT: Immunizations: medical exemptions

SUMMARY:

1. Requires the Department of Public Health (DPH) to develop a statewide standardized medical exemption request form for immunization requirements in existing law. Requires DPH to make the request form available for use by physicians. Requires the request form to be the only medical exemption documentation that a governing authority may accept. Requires a request form to be approved or denied only by the State Public Health Officer, upon a determination that the request provides sufficient medical evidence that the immunization is contraindicated by guidelines of the Centers for Disease Control and Prevention. Requires DPH to create and maintain a database of approved medical exemption requests. Requires DPH to make the information in the database accessible to local public health officers.

Existing law:

1. Requires DPH to examine the causes of communicable disease in man and domestic animals occurring or likely to occur in this state. [HSC §120125]
2. Gives the State Public Health Officer (PHO), as the director of DPH, broad authority to detect, monitor, and prevent the spread of communicable disease in the state, including the ability to:
   1. Require reporting of communicable disease that DPH identifies, on timelines and in a manner determined by DPH;
   2. Adopt and enforce regulations requiring strict or modified isolation, or quarantine, for any of the contagious, infectious, or communicable diseases, if in the opinion of DPH, the action is necessary for the protection of the public health;
   3. Take measures as are necessary to ascertain the nature of the disease and prevent its spread. Permits DPH, to that end, if it considers it proper, to take possession or control of the body of any living person, or the corpse of any deceased person;
   4. Quarantine, isolate, inspect, and disinfect persons, animals, houses, rooms, other property, places, cities, or localities, whenever in its judgment the action is necessary to protect or preserve the public health; and,
   5. Destroy such objects as bedding, carpets, household goods, furnishings, materials, clothing, or animals, when ordinary means of disinfection are considered unsafe, and when the property is in its judgment, an imminent menace to the public health. [HSC §120130, et seq.]
3. Requires a local health officer (LHO) knowing or having reason to believe that any case of reportable diseases, or any other contagious, infectious or communicable disease exists, or has recently existed, within the territory under his or her jurisdiction, to take measures as may be necessary to prevent the spread of the disease or occurrence of additional cases. [HSC §120175]

Prohibits the governing authority of a school or other institution from unconditionally admitting any person as a pupil of any private or public elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center, unless, prior to his or her first admission to that institution, he or she has been fully immunized against diphtheria, haemophilus influenzae type b (Hib), measles, mumps, pertussis, poliomyelitis, rubella, tetanus, hepatitis b (except after 7^th grade), and chickenpox, as specified. [HSC §120335]

Permits DPH to add to this list any other disease deemed appropriate, taking into consideration the recommendations of the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) Committee on Infectious Diseases. [HSC §120335]

Waives the above immunization requirements if the parent or guardian files with the governing authority a written statement by a licensed physician to the effect that the physical condition of the child is such, or medical circumstances relating to the child are such, that immunization is not considered safe, indicating the specific nature and probable duration of the medical condition or circumstances including, but not limited to, family medical history, for which the physician does not recommend immunization. [HSC §120370(a)]

Permits a child for whom the requirement has been waived, if there is good cause to believe that a child has been exposed to one of the specified communicable diseases and the child’s proof of immunization status does not show proof of immunization against that disease, to be temporarily excluded from the school or institution until the local health officer (LHO) is satisfied that the child is no longer at risk of developing or transmitting the disease. [HSC §120370(b)]

This bill:

1. Requires DPH to develop a statewide standardized medical exemption request form. Requires DPH to make the request form available for use by physicians. Requires the request form to be the only medical exemption documentation that a governing authority may accept.
2. Requires a request form to be approved or denied only by the PHO or his/her designee, upon a determination that the request provides sufficient medical evidence that the immunization is contraindicated by guidelines of the CDC.
3. Requires the request form to require, at a minimum: the physician’s name, medical license number, business address, and telephone number; the name of the child for whom the exemption is sought and the name of the child’s parent or guardian; a statement certifying that the physician has personally examined the child; and, a description of the medical reason for which the exemption is required.
4. Requires a physician, if a parent or guardian requests a medical exemption for a child, to inform the parent or guardian of the requirements of this bill. Requires the physician, if the parent or guardian consents, to examine the child and submit a completed request form to DPH.
5. Requires the PHO or his/her designee to review the completed request form and provide the physician with notification approving or denying the medical exemption request. Requires the reason for the denial, if the medical exemption request is denied, to be included in the notification. Permits the physician to submit additional information to DPH within 30 days from the notification for further review by the PHO or his/her designee.
6. Requires DPH to create and maintain a database of approved medical exemption requests. Requires DPH to make the information in the database accessible to local PHOs.
7. Requires a parent or guardian, if a medical exemption has been authorized under 5) of existing law above prior to the adoption of the statewide standardized medical exemption request form, to submit a copy of that medical exemption to DPH by July 1, 2020 for inclusion in the database in order for the medical exemption to remain valid.
8. Permits the PHO or a LHO to revoke a medical exemption if he/she determines that a medical exemption is fraudulent or inconsistent with applicable CDC guidelines.
9. Requires DPH to comply with all applicable state and federal privacy laws, as specified, in implementing this bill.
10. Makes technical, clarifying changes.

FISCAL EFFECT:

This bill has not been analyzed by a fiscal committee.

COMMENTS:

1. Author’s statement. According to the author, in the first four months of 2019, 465 measles cases have been reported across 19 states, a number far surpassing last year’s number of cases. Since elimination of measles in the U.S. in 2000, this is the second greatest number of cases reported. SB 277 (Pan and Allen, Chapter 35, Statutes of 2015) eliminated all non-medical exemptions for immunizations required for school entry. While SB 277 was successful in raising immunization rates, the number of medical exemptions issued more than tripled since the law went into effect. Many of the exemptions are clustered in the same schools, creating concentrated pockets of unvaccinated individuals. At almost 60 schools in the state, more than 10% of kindergarteners had medical exemptions. According to public health officials, the rise in medical exemptions is associated with an increase in physicians issuing exemptions for children without medically-justified contraindications. While the vast majority of physicians uphold standards of care, a small number of unethical physicians have monetized their license by selling medical exemptions for profit. Currently, California law requires no state-level oversight or standardization of exemptions. As a result, medical exemptions often contain incomplete information and may be issued for reasons other than medically-justified contraindications. This bill will restore integrity to California’s exemption process.
2. Immunizations. According to the World Health Organization, immunization is the process whereby a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine. Vaccines stimulate the body’s own immune system to protect the person against subsequent infection or disease. Immunization is a proven tool for controlling and eliminating life-threatening infectious diseases and is estimated to avert between two and three million deaths each year. It is one of the most cost-effective health investments, with proven strategies that make it accessible to even the most hard-to-reach and vulnerable populations. It has clearly defined target groups; it can be delivered effectively through outreach activities; and vaccination does not require any major lifestyle change.
3. ACIP. According to ACIP, it includes 15 voting members responsible for making vaccine recommendations. The Secretary of the U.S. Department of Health and Human Services (DHHS) selects these members following an application and nomination process. Fourteen of the members have expertise in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and/or preventive medicine; one member is a consumer representative who provides perspectives on the social and community aspects of vaccination. In addition to the 15 voting members, ACIP includes eight ex officio members who represent other federal agencies with responsibility for immunization programs in the United States, and 30 non-voting representatives of liaison organizations that bring related immunization expertise. The overall goals of ACIP are to provide advice to assist in reducing the incidence of vaccine-preventable diseases and to increase the safe usage of vaccines and related biological products. Professional organizations that work with ACIP to develop the annual childhood and adult schedules include the AAP, the American Academy of Family Physicians (AAFP), the American College of Obstetricians and Gynecologists (ACOG), and the American College of Physicians (ACP). The 2019 Recommended Immunization Schedules for Persons Aged 0 Through 18 Years state: children under six are recommended to receive vaccines for: hepatitis b; rotavirus; diphtheria, tetanus, and pertussis (DTaP); Hib; pneumococcal; polio; influenza; measles, mumps, rubella (MMR); varicella; hepatitis a; and meningococcal.
4. School vaccination requirements. States enact laws or regulations that require children to receive certain vaccines before they enter childcare facilities and school, but with some exceptions, including medical, religious, and philosophical objections. School vaccination requirements are thought to serve an important public health function, but can also face resistance. An article published in the 2001-2002 Kentucky Law Journal reviewed historical and modern legal, political, philosophical, and social struggles surrounding vaccination requirements. The authors stated that though school vaccination has been an important component of public health practice for decades, it has had a controversial history in the U.S. and abroad. Historical and modern examples of the real, perceived, and potential harms of vaccination, governmental abuses underlying its widespread practice and strongly held religious beliefs have led to fervent objections among parents and other persons who object to vaccines on legal, ethical, social, and epidemiological grounds. The article states that public health authorities argue that school vaccination requirements have led to a drastic decrease in the incidence of once common childhood diseases. Those who object to vaccines tend to view the consequences of mass vaccination on an individualistic basis, focusing on alleged or actual harms to children from vaccinations.
5. Exemptions to vaccine requirements. There are two types of non-medical exemptions states have incorporated into requirements that children be vaccinated before entering school: religious exemptions and philosophical exemptions. A religious exemption means that there is a provision in the statute that allows parents to exempt their children from vaccination if it contradicts their sincere religious beliefs. A philosophical exemption means that the statutory language does not restrict the exemption to purely religious or spiritual beliefs. According to the National Conference of State Legislatures, all 50 states have laws requiring specified vaccines for students. Although exemptions vary from state to state, all school immunization laws grant exemptions to children for medical reasons. Almost all states grant religious exemptions for people who have religious beliefs against immunizations. California, Mississippi, and West Virginia allow only medical exemptions. Currently, 17 states allow philosophical exemptions for those who object to immunizations because of personal, moral or other beliefs. According to the CDC, state and local vaccination requirements for daycare and school entry are important tools for maintaining high vaccination coverage rates, and in turn, lower rates of vaccine-preventable diseases. These laws often apply not only to children attending public schools but also to those attending private schools and day care facilities. Studies have shown that vaccine exemptions tend to cluster geographically, making some communities at greater risk for outbreaks.
6. Contraindications and precautions. According to the CDC’s General Best Practice Guidelines for Immunization: Contraindications and Precautions, contraindications (conditions in a patient that increases the risk for a serious adverse reaction) and precautions to vaccination are conditions under which vaccines should not be administered. Persons who administer vaccines should screen patients for contraindications and precautions before each dose of vaccine is administered. Because the majority of contraindications and precautions are temporary, vaccinations often can be administered later when the condition leading to a contraindication or precaution no longer exists. A couple examples of contraindications include that severely immunocompromised persons generally should not receive live vaccines. Because of the theoretical risk to the fetus, pregnant women generally should not receive live, attenuated virus vaccines. A precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the ability of the vaccine to produce immunity. A person might experience a more severe reaction to the vaccine than would have otherwise been expected; however, the risk for this happening is less than the risk expected with a contraindication. In general, vaccinations should be deferred when a precaution is present. However, a vaccination might be indicated in the presence of a precaution if the benefit of protection from the vaccine outweighs the risk for an adverse reaction. As an example, the presence of a moderate or severe acute illness is a precaution to administration of all vaccines. The decision to administer or delay vaccination depends on the severity of symptoms and cause of the condition. According to the Guidelines, screening for contraindications, persons with moderate or severe acute illness should be vaccinated as soon as the illness has improved.
7. California vaccination rates. According to DPH’s 2017-18 Kindergarten Immunization Assessment, each autumn California schools are required to report the status of their students under state immunization requirement laws. 2017-2018 is the second full school year that entrants have been subject to SB 277, which no longer permits them to receive personal beliefs exemptions from immunization requirements. The proportion of students attending kindergarten in 2017-2018 reported to have received all required vaccines is 95.1%, a 0.4 percentage point decrease from the 2016-2017 school year and a 4.7 percentage point increase over the three years since 2014-2015. Compared to 2016-2017, in 2017-2018 the proportion of kindergartners reported as:
   1. Having permanent medical exemptions increased from 0.5% to 0.7%;
   2. Lacking immunizations for other reasons specified under SB 277 increased from 0.5% to 1.1%, with 0.8% reported as being enrolled in independent study programs; and,
   3. Being overdue for required immunizations increased from 1.0% to 1.2%.

According to DPH, possible explanations for the overall improvements in recent years in the reported immunization coverage of kindergarteners in California include efforts by public health departments, schools, medical providers and partner organizations to help ensure that children meet school immunization requirements; increased public awareness about the importance of immunizations in the aftermath of outbreaks of vaccine-preventable diseases; recent laws (including SB 277); and review of eligible schools in 2016 and 2017 for compliance with immunization laws, as a component of comprehensive state-mandated financial audits of local education agencies.

1. California measles outbreak. SB 277 was, in part, prompted by a December 2014 a measles outbreak that began in Disneyland (Orange County) and resulted in 134 confirmed measles cases. Of the confirmed cases: 40 cases visited Disneyland between December 17 and December 20 where they are presumed to have been exposed to measles; 30 are household or close contacts to a confirmed case; 11 were exposed in a community setting (e.g., emergency room) where a confirmed case was known to be present; 50 have an unknown exposure source but are presumed to be linked to the outbreak based on a combination of descriptive epidemiology or strain type; and, three cases are known to have a different genotype from the outbreak strain. The ages of those infected with the measles during this outbreak varied, with 56% being 20 years or older, 18% were between the ages of five and 19, 15% were ages one to four, and 11% were under the age of one. Among measles cases for whom DPH have vaccination documentation, 57 were unvaccinated and 25 had one or more doses of MMR vaccine.
2. 2019 outbreaks. According to the CDC, from January 1 to April 19, 2019, 626 individual cases of measles have been confirmed in 19 states. This is the second-greatest number of cases reported in the U.S. since measles was eliminated in 2000. The states that have reported cases to CDC are Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, Nevada, New Hampshire, New Jersey, New York, Oregon, Texas, and Washington. Two outbreaks have been highly publicized in the news: Washington and New York. In Clark County, Washington, there have been 73 confirmed cases since January 1. Of these cases, 53 were age one to ten years, 15 cases were 11 to 18 years, one case was 19 to 29 years, and four cases were 30 to 39 years. Sixty three infected individuals were unimmunized. In New York City, as of April 18, 2019, there have been 359 confirmed cases of measles in Brooklyn and Queens since October. According to the city’s health department, most of these cases have involved members of the Orthodox Jewish community. The initial child with measles was unvaccinated and acquired the disease on a visit to Israel, where a large outbreak is occurring. Since then, there have been additional people from Brooklyn and Queens who were unvaccinated and acquired measles while in Israel. People who did not travel were also infected in Brooklyn or Rockland County. On April 9, the Health Commissioner ordered every adult and child who lives, works or resides in the certain ZIP codes and has not received the MMR vaccine to be vaccinated or face a fine of $1,000.
3. Prior legislation. SB 277 (Pan and Allen, Chapter 35, Statutes of 2015) eliminates the PBE from the requirement that children receive vaccines for certain infectious diseases prior to being admitted to any public or private elementary or secondary school or day care center.

SB 792 (Mendoza, Chapter 807, Statutes of 2015) prohibits a person from being employed at a day care center or day care home unless he or she has been immunized against influenza, pertussis, and measles.

SB 2109 (Pan, Chapter 821, Statutes of 2012), requires a separate form prescribed by DPH to accompany a letter or affidavit to exempt a child from immunization requirements on the basis that an immunization is contrary to beliefs of the child’s parent or guardian. The Governor included a message with his signature on this bill, which stated, in part, “I will direct (DPH) to allow for a separate religious exemption on the form. In this way, people whose religious beliefs preclude vaccinations will not be required to seek a health care practitioner’s signature.” This bill’s provisions were deleted by SB 277.

AB 2064 (V. Manuel Pérez), would have required a health plan or health insurer that provides coverage for childhood and adolescent immunizations to reimburse a physicians in an amount not less than the actual cost of acquiring the vaccine plus the cost of administration of the vaccine, as specified. AB 2064 was held on the Assembly Appropriations Committee suspense file.

SB 614 (Kehoe, Chapter 123, Statutes of 2011) allows a pupil in grades 7 through 12, to conditionally attend school for up to 30 calendar days beyond the pupil’s first day of attendance for the 2011-12 school year, if that pupil has not been fully immunized with all pertussis boosters appropriate for the pupil’s age if specified conditions are met.

AB 354 (Arambula, Chapter 434, Statutes of 2010) allows DPH to update vaccination requirements for children and adds the AAFP to the list of entities whose recommendations DPH must consider when updating the list of required vaccinations. Requires children entering grades 7 through 12 receive a TDaP booster prior to admittance to school.

AB 1201 (V. Manuel Pérez of 2009) would have required a health plan or health insurer that provides coverage for childhood and adolescent immunizations to reimburse a physicians the entire cost of acquiring and administering the vaccine, and would have prohibited cost-sharing for immunizations. AB 1201 was held on the Assembly Appropriations Committee suspense file.

SB 1179 (Aanestad of 2008) would have deleted DPH’s authority to add diseases to the list of diseases that pupils are required to be immunized against. SB 1179 died in Senate Health Committee.

AB 2580 (Arambula of 2008) would have required pupils entering the 7^th grade to be immunized against pertussis by receiving any necessary adolescent booster immunization. AB 2580 was held on the Senate Appropriations Committee suspense file.

SB 676 (Ridley-Thomas of 2007) would have required pupils entering the 7^th grade to be fully immunized against pertussis. SB 676 was held on the Assembly Appropriations Committee suspense file.

SB 533 (Yee of 2007) would have added pneumococcus to the list of diseases that pupils are required to be immunized against. SB 533 was vetoed by the Governor, who stated that a mandate for this vaccination was not necessary.

1. Support. American Academy of Pediatrics, California states that the CDC reports that in 2018, 21 people contracted measles in California. So far, several months into 2019, 17 confirmed measles cases, including 11 outbreak-associated cases, have been reported. Left unchecked, we will continue to see the number of cases and outbreaks rise. Just recently, the City of New York declared a measles outbreak a public health emergency, where there have been 285 confirmed cases; 21 of those cases led to hospitalizations, including five admissions to the intensive care unit. Only a very small percentage of the population, less than 1%, suffers from a qualifying medical condition - such as a severe allergic reaction to a vaccine component - that would lead to the granting of a medical exemption. The California Medical Association writes that public health officials, medical providers, lawmakers, the media, and parents of immunocompromised children have raised concerns that a small number of physicians are monetizing their exemption-granting authority and profiting from the sale of medical exemptions. These physicians are not upholding the patient standard of care and therefore put the public at risk. They are undermining the integrity of other physicians who grant medically necessary exemptions for the 1% of patients who truly need them. The County Health Executives Association of California writes that medical exemptions in California have nearly tripled since the passage of SB 277 and the rates of medical exemptions in certain pockets of our state are as high as 20%. Despite these alarming increases in medical exemptions and a rise in vaccine-preventable diseases, such as measles, no mechanism currently exists to allow for a review of those medical exemptions. Vaccinate California states that parents across the state who fought to secure SB 277 are again worried that the significant pockets of “personal belief” exemptions have transformed into significant pockets of unjustified medical exemptions and that our children remain at risk. They believe that medical exemptions should only be given to those who truly need them, such as children who need surgery and must delay vaccines, children with cancer or who are otherwise immunocompromised, and children who are allergic to vaccine components (who rely on herd immunity for survival).

The California School Nurses Organization writes that certain schools and school districts have high rates of unvaccinated children, thus resulting in higher incidence of vaccine preventable diseases. Having “community immunity”¹ varies by vaccine but it provides protection for those students and staff who for medical reasons are unable to be vaccinated or are immunocompromised. However, California is now are faced with increased rates of measles and pertussis in spite of our increase rates of vaccination, 95%, which while quite high still, is not protective because of the increased numbers of students who have gained medical exemptions. The Children’s Specialty Care Coalition writes that this bill will reshape California’s process to require state-level public health approval of all medical exemptions, and will help protect the most vulnerable, including babies too young to be immunized and people who are immunocompromised, from the risks associated with contracting these diseases. This bill will also protect the community at large from increased outbreaks of vaccine-preventable disease. The Health Officers Association of California writes that despite the effectiveness of vaccines, California’s public health departments have seen a rise in vaccine-preventable diseases such as pertussis and measles largely because many residents are choosing to selectively immunize or opt out of vaccinating their children. These decisions risk the health of the community and can be particularly detrimental, or even fatal, to newborns, infants, toddlers, and those living with immunocompromising health conditions. The California Hospital Association writes that immunizations have had an enormous impact on the health of children, and the prevention of disease by vaccination is one of the single greatest public health achievements of the last century, and that vaccine development is a long, detailed process, requiring that vaccines demonstrate both safety and efficacy before licensure, and are actively monitored thereafter. Given the highly contagious nature of diseases such as measles, vaccination rates of at least 95% are necessary to preserve what is called “community immunity” and prevent future outbreaks.

1. Opposition. Educate.Advocate. writes that this bill will create additional burden for students with exceptional needs and their families both emotionally and financially, harming their access to education by discouraging school districts from providing special education services to students who do not meet new medical exemption requirements. This bill mandates the creation and maintenance of a statewide database, to include approved medical exemption requests, under which personally identifiable health information of students with exceptional needs and family members will be included in a medical exemption database. Databases are at risk for ‘hacking’, exposing confidential medical information to insurance companies, higher education institutions and future employers, who may discriminate based on pre-existing conditions and disabilities. Further, the database will have no opt-out feature, currently available in the California Immunization Registry. Physicians for Informed Consent states that this bill is unscientific because SB 277-mandated vaccines have not yet been proven to be less risky than the diseases they are designed to prevent. Further, this bill is unethical because it promotes medical bullying by governmental agents and obstructs parents from being able to protect their children from the potential risk of vaccine injuries (i.e., it violates the principle of informed consent/informed refusal); thwarts doctors from being able to protect their patients’ health through personalized vaccine recommendations based on infectious disease risks and individualized vaccine-injury risks, and instead promotes an outdated one-size-fits-all governmental vaccine schedule which is not based on new medical discoveries; and, subjects the health of California’s children to the mercy of a State PHO with whom they don’t have a patient-doctor relationship. Moms Across America states that vaccines carry risks, and significant risks to certain individuals, as identified by the payouts of the National Vaccine Injury Compensation Program, with over $4 billion paid out by this program to a very small percentage of the children actually reported to be damaged, it is undeniable that vaccination is not safe nor effective for all. Medical exemptions prevent not only damage to our children but expensive special education, state funded therapies, legal trials, and payouts to injured families. Further, removing personal physicians from this equation and putting it in the hand of the state will not serve our children. The CDC’s criteria for medical exemptions is not inclusive of the necessary symptoms that signal serious health and learning implications. Removing the knowledge of the pediatrician’s expertise of a multitude of serious health implications which include genetic and familial connections, increases the risks of permanent damage or death as a result of continuing to vaccinate some children.

The Association of American Physicians and Surgeons states that the traditional ethic in the Oath of Hippocrates requires physicians to refrain from deliberately harming patients, and that this bill denies patients the protection of this code and is instead imposing on them the judgment of a government agency. Unlike physicians, these officials have no accountability for harm that individual patients may suffer. Vaccines are unavoidably unsafe, as recognized by the U.S. Supreme Court, and also by Congress in establishing the Vaccine Injury Compensation Program. Most doctors nevertheless recommend many vaccines, as they believe the benefit to the patient exceeds the risk. The public health authorities, on the other hand, may impose their dictates on the presumption that the overall benefit to the population, as they calculate it, overrides individual rights or more than counterbalances any adverse effects that individuals may endure. History shows that many serious adverse effects of medical intervention may be unrecognized for long periods of time. Bureaucracies are by nature glacially slow in updating their policies—especially when conflicts of interest occur. A mistaken policy can cause far more harm than errors by individuals. Thus, protecting individuals’ freedom also protects the population, as individuals can adapt far more quickly to new information or circumstances.

SUPPORT AND OPPOSITION:

Support: American Academy of Pediatrics, California (co-sponsor)

California Medical Association (co-sponsor)

Vaccinate California (co-sponsor)

Advanced Medical Technology Association

AIDS Healthcare Foundation

American College of Cardiology, California Chapter

American College of Physicians, California Chapter

California Academy of Family Physicians

California Academy of Pain Medicine

California Association of Professional Scientists

California Hospital Association

California Immunization Coalition

California Life Sciences Association

California Optometric Association

California Orthopaedic Association

California School Nurses Organization

California State Association of Counties

Children’s Defense Fund

Children’s Specialty Care Coalition

County Health Executives Association of California

Health Officers Association of California

Infectious Disease Association of California

Kaiser Permanente

March of Dimes

Orthopedic Surgery Specialists Medical Group

Providence St. Joseph Health

Over 700 individuals

Oppose: A Voice for Choice Advocacy

Alliance for Natural Health USA

Association of American Physicians and Surgeons

California Health Coalition Advocacy

California Right to Life Committee, Inc.

Californians for Trusted Healthcare

Educate.Advocate.

Moms Across America

National Health Freedom Action

National Vaccine Information Center

Physicians for Informed Consent

Physicians’ Association for Anthroposophic Medicine

Vaccine-Injury Awareness League

West Virginians for Health Freedom

Over 800 individuals

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