BILL ANALYSIS Ó SENATE COMMITTEE ON HEALTH Senator Ed Hernandez, O.D., Chair BILL NO: AB 2109 AUTHOR: Pan AMENDED: June 20, 2012 HEARING DATE: June 27, 2012 CONSULTANT: Moreno SUBJECT : Communicable disease: immunization exemption. SUMMARY : Requires, after July 1, 2014, a separate form prescribed by the Department of Public Health (DPH) to accompany a letter or affidavit to exempt a child from immunization requirements under existing law on the basis that immunization is contrary to beliefs of the child's parent or guardian. Existing law: 1.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. 2.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. 3.Waives the above requirements if the parent or guardian or adult who has assumed responsibility for the child's care and custody, or the person seeking admission, if an emancipated minor, files a letter or affidavit with the governing authority stating that the immunization is contrary to his or her beliefs. 4.Permits a child for whom the requirement has been waived, whenever there is good cause to believe that he or she has been exposed to one of the specified communicable diseases, to Continued--- AB 2109 | Page 2 be temporarily excluded from the school or institution until the local health officer is satisfied that the child is no longer at risk of developing the disease. This bill: 1.Requires, after July 1, 2014, 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 immunization is contrary to the beliefs of the child's parent or guardian. 2.Requires the form to include: a. A signed attestation from a health care practitioner that indicates that he or she provided the parent or guardian of the person who is subject to the immunization requirements in existing law, the adult who has assumed responsibility for the care and custody of the person, or to the person if he or she is a emancipated minor, with information regarding the benefits and risks of the immunization and the health risks of specified communicable diseases to the person and to the community. b. A written statement signed by the parent or guardian of the person who is subject to the immunization requirements in existing law, the adult who has assumed responsibility for the care and custody of the person, or the person if he or she is an emancipated minor, that indicates that the signer has received the information provided by the health care practitioner. 3.Requires the form to be signed not more than 6 months prior to the date when the person first becomes subject to the immunization requirement for which exemption is being sought. 4.Permits a photocopy of the signed form or a letter signed by a health care practitioner that includes all information and attestations included on the form to be accepted in lieu of the original form. 5.Defines, for the purposes of this bill, a "health care practitioner" as a physician and surgeon, a nurse practitioner, a physician assistant, an osteopathic physician and surgeon, or a naturopathic doctor, as specified. 6.Exempts issuance and revision of the form from rulemaking requirements under the Administrative Procedure Act. AB 2109 | Page 3 FISCAL EFFECT : According to the Assembly Appropriations Committee, based on DPH experience with another recent change to immunization requirements, one-time costs for notification including printing, mailing, and development of informational materials in the range of $80,000 federal funds. Issuing regulations and developing the form would result in one-time staff time costs of $50,000, distributed among a number of existing federally funded staff. a.Minor, absorbable one-time costs to Department of Social Services (DSS) Child Care Licensing Division staff and K-12 school administrative staff for training on the new requirement. b.Potential increase of $20,000 General Fund/98 annually in state-reimbursable mandate costs to K-12 school administrative staff to ensure compliance with the new form. DSS costs related to ongoing enforcement are expected be minor and absorbable. c.Any impact on Medi-Cal or Healthy Families Program from a small number of increased office visits, to the extent any program enrollees seek exemptions and require additional office visits to do so, is likely to be negligible. PRIOR VOTES : Assembly Health: 13- 5 Assembly Appropriations:12- 5 Assembly Floor: 47- 26 COMMENTS : 1.Author's statement. California is 1 of only 20 states that allows for a personal beliefs, or philosophical exemption to school or childcare immunization requirements. Under existing law, to exempt the child from the immunization requirements, a parent or guardian must only provide a signed written statement or sign their name to a two-sentence standard exemption statement on the back of the School Immunization Record. While parents do have a choice to exempt their children, they are not required to document their concerns about vaccines or affirm that they have reviewed fact-based, accurate information regarding the risks and benefits of vaccines and the risks of vaccine-preventable diseases. The continued increase in personal belief exemptions and resultant decreases in community immunization rates in California will result in outbreaks of diseases such as measles, mumps, and pertussis. Exposure to these preventable diseases not only AB 2109 | Page 4 places the individual child at risk, but the entire community, including infants too young to be fully immunized and individuals with compromised immune systems, who are vulnerable to complications of vaccine-preventable diseases, including death. his measure would rectify this problem by creating a process where parents would be able make an informed decision for their children. 2.Immunizations. According to the CDC, vaccines contain the same antigens or parts of antigens that cause diseases, but the antigens in vaccines are either killed or greatly weakened. Vaccine antigens are not strong enough to cause disease but, they are strong enough to make the immune system produce antibodies against them. Memory cells prevent re-infection when they encounter that disease again in the future. Vaccines are responsible for the control of many infectious diseases that were once common around the world, including polio, measles, diphtheria, pertussis (whooping cough), rubella (German measles), mumps, tetanus, and Hib. Vaccine eradicated smallpox, one of the most devastating diseases in history. Over the years, vaccines have prevented countless cases of infectious diseases and saved literally millions of lives. Vaccine-preventable diseases have a costly impact, resulting in doctor's visits, hospitalizations, and premature deaths. Sick children can also cause parents to lose time from work. CDC recommends routine vaccination to prevent 17 vaccine-preventable diseases that occur in infants, children, adolescents, or adults. According to DPH, implementation of statewide immunization requirements has been effective in maintaining a 92 percent immunization coverage rate among children in licensed child care facilities and kindergartens. 3.ACIP. ACIP consists of 16 experts in fields associated with immunization who have been selected by the Secretary of the U.S. Department of Health and Human Services to provide advice and guidance to the Secretary, the Assistant Secretary for Health, and the CDC on the most effective means to prevent vaccine-preventable diseases. ACIP develops written recommendations for the routine administration of vaccines to pediatric and adult populations, along with schedules regarding the appropriate periodicity, dosage, and contraindications applicable to the vaccines and is the only entity within the federal government which makes such recommendations. The overall goals of ACIP are to provide advice to assist in reducing the incidence of AB 2109 | Page 5 vaccine-preventable diseases and to increase the safe usage of vaccines and related biological products. ACIP, along with AAP and the American Academy of Family Physicians, approved the 2012 Recommended Immunization Schedules for Persons Aged 0 Through 18 Years. 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 United States 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. As part of their research, the authors compared childhood immunization rates and rates of vaccine-preventable childhood diseases before and after the introduction of school vaccination requirements. The data suggest that school vaccination requirements have succeeded in increasing vaccination rates and reducing the incidence of childhood disease. AB 2109 | Page 6 5.Exemptions to vaccine requirements. There are two types of non-medical exemptions to the requirement that children be vaccinated before entering school: religious exemption and philosophical exemption. 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. Philosophical exemption means that the statutory language does not restrict the exemption to purely religious or spiritual beliefs. For example, Maine allows restrictions based on "moral, philosophical or other personal beliefs," and California allows objections based on simply the parent(s) beliefs. According to the National Conference of State Legislatures, as of February 2012, 48 states allow religious exemptions (all but Mississippi and West Virginia), and 20 states (Arizona, California, Colorado, Idaho, Louisiana, Maine, Michigan, Minnesota, Missouri (limited to daycare, preschool and nursery school), New Mexico, North Dakota, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Vermont, Washington, West Virginia and Wisconsin) permit philosophic exemptions. The criteria for allowing these exemptions vary greatly by state. Some states require membership in a recognized religion, whereas other states, merely require an affirmation of religious (or philosophic) opposition. 6.Author's briefing. On February 29, 2012, the author hosted a briefing, "Disease Prevention through Immunization: A Community Responsibility," which included topics relating to vaccines and preventable diseases, how immunization recommendations are developed and vaccine safety, and the increase in personal belief exemptions (PBEs). During the briefing, it was pointed out that the number of parents or guardians choosing to exempt their children from school immunization requirements has increased. DPH demonstrated the trend in PBE among kindergarten students over a 32-year span, which has gone from below .5 percent in 1978 to almost 2.5 percent in 2010. DPH also presented a map of the percentage of PBEs in each of California's counties, which range significantly. In Del Norte, Humboldt, Shasta, Mendocino, Sonoma, Marin, Santa Cruz, Butte, Plumas, Nevada, El Dorado, and San Luis Obispo counties, between 5 percent and 17.7 percent of children are entering kindergarten with PBEs. Santa Barbara, Ventura, Orange, and San Diego Counties have between 2.5 percent and 4.9 percent of children entering kindergarten with PBEs. AB 2109 | Page 7 Merced, Glen, Alpine, and Imperial counties have the least percentage of kindergarteners with PBEs, with less than one percent. DPH indicated that the reasons for non-vaccination nationwide include perception that children had low susceptibility to these diseases, severity of the diseases was low, efficacy and safety of the vaccines was low, and the most frequent reason (stated by 69 percent of the parents) was the concern the vaccine might cause harm. 7.Physician dismissing of patients. In stressing that this bill would have a negative impact on families, the opponents to this bill submitted two studies to demonstrate the prevalence of physicians dismissing families who delay and/or refuse vaccination. A 2011 article published in Public Health Reports titled, "Physicians' Experience with and Response to Parental Vaccine Safety Concerns and Vaccine Refusals: A Survey of Connecticut Pediatricians" (2011 Article) examined how frequently pediatricians in one New England state encounter parental vaccine safety concerns and vaccine refusals. According to the 2011 Article, the study consisted of a quantitative survey of 133 pediatricians who completed a questionnaire; the majority of responding pediatricians reported an increase in parental vaccine safety concerns and refusals. More than 30 percent indicated they have dismissed families because of their refusal to immunize. Suburban physicians caring for wealthier, better educated families experience more vaccine concerns and/or refusals and are more likely to dismiss families for vaccine refusal. According to the 2011 Article, vaccine refusals have a negative personal impact on one-third of physician respondents. The 2011 Article also points out the AAP, American Medical Association, and CDC all recommend against discharging families solely based on vaccine refusal. In a 2005 study entitled "Dismissing the Family Who Refuses Vaccines" published in the Archives of Pediatrics & Adolescent Medicine (2005 Study), the objective was to describe pediatrician's responses to scenarios of vaccine refusal, identify reasons pediatricians cite for both parent refusal and family dismissal and to illustrate pediatrician attitudes about well-established versus newer recommended vaccines. The 2005 Study conducted a nationwide survey mailed to 1,004 randomly selected members of AAP in Illinois. The study found: 54 percent faced total vaccine refusal during a 12-month period; pediatricians cited safety concerns as a top reason AB 2109 | Page 8 for parent refusal; 39 percent said they would dismiss a family for refusing all vaccinations; and 28 percent said they would dismiss a family for refusing select vaccines. 8.Related legislation. AB 2064 (V. Manuel Pérez) 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, as specified. AB 2064 was held on suspense in the Assembly Appropriations Committee. 9.Prior legislation. 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. 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. 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 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 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 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 Senate Health Committee. AB 2580 (Arambula) of 2008 would have required pupils entering AB 2109 | Page 9 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. 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. 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, who stated that a mandate for this vaccination was not necessary. 10.Support. The AAP, California Medical Association, and the Health Officers Association of California (HOAC), joint sponsors of this bill, state that this bill would increase protection for children and communities from vaccine-preventable diseases, while still respecting and preserving parent choice. They state that the continued increase in PBEs and resultant decreases in community immunization rates could have a significant impact on public safety and because PBEs are relatively easy to obtain, parents or schools may use them simply because they find vaccination inconvenient, or because they have been misinformed about the health effects of vaccines. The California Maternal, Child and Adolescent Health Directors, the California School Health Centers Association, March of Dimes, and the California Black Health Network state that this bill will make certain that all parents are aware of the individual and public health risks of exempting a child from required immunizations. They also state that this bill increases the protection of children and communities from vaccine-preventable diseases while still respecting and preserving parent choice. 11.Opposition. The Pacific Justice Institute states that existing law provides a reasonable process for exemptions from mandated student vaccinations. This bill changes the current AB 2109 | Page 10 approach and inserts more bureaucracy into intimate medical decisions. Health Advocacy in the Public Interest indicates that parents must have the freedom to make their own decisions with respect to the vaccination of their children. Numerous letters from individuals, parents, and practitioners state that this bill is an intrusion into the personal freedom of parents to make health care decisions for their children. They state that this measure causes an undue burden on parents, discriminates against families utilizing complementary and alternative medicine, and promotes more vaccine use and profit from the pharmaceutical industry. SUPPORT AND OPPOSITION : Support: American Academy of Pediatrics (co-sponsor) California Medical Association (co-sponsor) Health Officers Association of California (co-sponsor) Association of Northern California Oncologists BayBio California Black Health Network California Hepatitis C Task Force California Immunization Coalition California Naturopathic Doctors Association California Pharmacists Association California Primary Care Association California School Health Centers Association California State Association of Counties County Health Executives Association of California Los Angeles County Board of Supervisors Los Angeles Unified School District March of Dimes California Chapter San Francisco Immunization Coalition Santa Clara County Board of Supervisors Tracy Unified school District Two individuals Oppose: California Federation of Republican Women California Right to Life Committee, Inc. Canary Party Child and Family Protection Association CORE Sacramento Health Advocacy in the Public Interest Maher Insurance and Financial Services National Vaccine Information Center Pacific Justice Institute ParentalRights.Org Private School Advocacy Center AB 2109 | Page 11 Over 400 individuals -- END --