BILL ANALYSIS Ó AB 2109 Page 1 Date of Hearing: April 17, 2012 ASSEMBLY COMMITTEE ON HEALTH William W. Monning, Chair AB 2109 (Pan) - As Introduced: February 23, 2012 SUBJECT : Communicable disease: immunization exemption. SUMMARY : Makes changes to existing requirements which allow school-aged children, as specified, to be exempt from immunization requirements as long as a parent or a guardian files a letter or affidavit to the governing authority indicating that immunization is contrary to the parent or guardian's beliefs. Specifically, this bill : 1) Requires, on and after July 1, 2012, a separate form prescribed by the California Department of Public Health (DPH), to accompany the letter or affidavit to exempt a child, as specified, from required immunization requirements because immunization is contrary to the child's parent's or guardian's beliefs. 2) Requires the form in 1) above to include both of the following: a) A written statement signed by a health care practitioner that indicates that the health care practitioner provided the parent or guardian of the person, or the person if an emancipated minor, who is subject to the immunization requirements, with information regarding the benefits and risks of the immunization and the health risks of the communicable diseases, as specified, to the person and to the community; and, b) A written statement signed by the parent or guardian of the person, or the person if an emancipated minor, who is subject to the immunization requirements that indicates the information specified in 2) a) above was received. 3) Requires the written statements signed by the health care practitioner and the parent or guardian, as specified in 2) a) and b) above to be signed not more than six months from the date when the person subject to the immunization AB 2109 Page 2 requirements is first admitted to the school. States that if the person was admitted to the school prior to entering the seventh grade and is about to enter the seventh grade, then an additional letter or affidavit shall be filed with the written statement signed by the parent or health care practitioner not more than six months from the first day of school. 4) Authorizes a copy of the signed written statement to be accepted in lieu of the original form. Requires a signed letter from the health care practitioner that references the person's name to be accepted in lieu of a statement on the original form. 5) Defines a health care practitioner for purposes of this bill as any of the following: a) A physician and surgeon licensed by the Medical Board of California; b) A nurse practitioner (NP) who is authorized to furnish drugs, as authorized by law; or, c) A physician assistant (PA) who is authorized to administer or provide medication, as authorized by law. EXISTING LAW : 1) Establishes the Division of Communicable Disease Control (DCDC) within DPH to promptly identify, prevent, and control infectious diseases that pose a threat to public health, including emerging and re-emerging infectious diseases, vaccine-preventable agents, bacterial toxins, bioterrorism, and pandemics. 2)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: Diphtheria; Haemophilus influenza type b,; measles; mumps; pertussis; poliomyelitis; rubella; tetanus; hepatitis B; varicella (chickenpox); and, any other disease deemed AB 2109 Page 3 appropriate by DPH, taking into consideration the recommendations of Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians. 3)Waives the requirement in 2) above for medical reasons or if the parent, guardian or adult who has assumed responsibility for the child files a letter or affidavit with the school governing authority stating that the immunization is contrary to his or her beliefs. 4)Permits a child who has had an immunization requirement waived, whenever there is good cause to believe that he or she has been exposed to one of specified communicable diseases, to be temporarily excluded from the school or institution until the local health officer is satisfied that he or she is no longer at risk of developing the disease. 5)Requires county health officers to organize and maintain a program to make immunizations available to all persons required to be immunized as specified in 2) above and other specified statutes, and requires counties to pay costs that are not recovered from persons immunized. FISCAL EFFECT : This bill has not yet been analyzed by a fiscal committee. COMMENTS : 1)PURPOSE OF THIS BILL . According to the author, "California is one 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 AB 2109 Page 4 California will result in outbreaks of diseases such as measles, mumps, and pertussis. Exposure to these preventable diseases not only 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. This measure would rectify this problem by creating a process where parents would be able make an informed decision for their children." 2)BACKGROUND . a) Importance of Vaccination . According to the federal Centers for Disease Control and Prevention (CDC), because of advances in medical science, many children today are protected against more diseases than ever before. Some diseases that once injured or killed thousands of children have been eliminated completely and others are close to being gone because of safe and effective vaccines. For example, polio was once a feared disease causing death and paralysis but because of widespread vaccination, there are no reports of polio in the United States (U.S.). CDC points out that all vaccines are only given to children after a long and careful review by scientists, doctors, and healthcare professionals. Federal law requires ACIP to provide advice and guidance to the Secretary of the U.S. Department of Health and Human Services (HHS), the Assistant Secretary for Health, and the CDC on the most effective means to prevent vaccine-preventable diseases. Another goal of ACIP is to increase the safe usage of vaccines and related biological products. ACIP consists of 15 experts in fields associated with immunization who have been selected by the HHS Secretary, and is the only entity in the federal government which develops recommendations for the routine administration of vaccines to children and adults, along with schedules regarding the age for vaccine administration, appropriate dosage, dosing intervals, precautions, and contraindications applicable to the vaccines. b) Exemptions from School Immunization Requirements . AB 2109 Page 5 School-aged children are required to obtain immunizations for certain types of diseases to be admitted in school. There are exceptions to this requirement. First, if the physical or medical condition of a child would make immunization unsafe, as long as a statement by a licensed physician to this effect is submitted to the governing authority. Second, if a letter or affidavit is filed with the governing authority indicating that the immunization is contrary to the beliefs of a parent or guardian; this exemption is generally referred to as the personal belief exemption (PBE) or philosophic exemption. According to the CDC, aside from the philosophic exemption, some states allow for religious exemptions on the ground that the religious beliefs of some people are in opposition to vaccination. The National Conference of State Legislatures state that forty-eight states allow religious exemptions (all but Mississippi and West Virginia), and 20 states (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, 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, including California merely require an affirmation of religious (or philosophic) opposition. c) Legislative Briefing . On February 29, 2012 the author hosted a legislative briefing entitled "Disease Prevention through Immunization: A Community Responsibility." The briefing included topics relating to vaccines and preventable diseases, how immunization recommendations are developed and how we know vaccines are safe, and the rapid surge in PBEs. During the legislative briefing, it was pointed out that the number of parents or guardians choosing to exempt their children from school immunization requirements has increased. The graph below, provided by DPH, shows the trend in PBE among kindergarten students from 1978-2010. AB 2109 Page 6 DPH also presented a map of the percentage of PBEs in each of California's counties. Populations in Del Norte, Humboldt, Shasta, Mendocino, Sonoma, Marin, Santa Cruz, Butte, Plumas, Nevada, El Dorado, and San Luis Obispo Counties have a ratio of 5% to 17.7% of PBEs. Santa Barbara, Ventura, Orange, and San Diego Counties range from about 2.5% to 4.9% of PBEs; and, Merced, Glen, and Alpine Counties have the least, each with less than 1% PBEs. DPH indicated that the reasons for non-vaccination 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% of the parents) was the concern the vaccine might cause harm. During the briefing, AAP, the California Immunization Coalition, and the California Medical Association (CMA) stated the following: based on 2010 research data from DPH, the California Department of Education, and the U.S. Census, California had about 11,500 kindergartners with PBEs, representing a 25% increase over the previous two years. The 2010 Kindergarten Assessment Report which monitors compliance with the California School Immunization Law, identifies the overall total of kindergarten entrants with a PBE at 2.33%; with a range from 0% in Alpine County to nearly 18% in Nevada County; and, over 30% of counties had exemption rates more than 5%. d) Examples of Outbreaks . During the Legislative briefing, several outbreaks were discussed by DPH, including a 2008 San Diego measles outbreak where one intentionally unvaccinated seven year old unknowingly infected with measles returned from Switzerland, resulting in 839 people exposed. The outbreak was fueled by clusters of additional intentionally unvaccinated children and perpetuated by delayed clinical diagnosis and inadequate infection-control measures. The total outbreak costs in dollars alone were $176,980. The H1N1 outbreak is a more recent example. H1N1 is a new strain of the influenza virus that first appeared in the U.S. in April 2009 and spread worldwide. The symptoms of AB 2109 Page 7 H1N1 are similar to the regular human seasonal flu infection. According to DPH's Website, by December 2009, more than 8,000 people in California were hospitalized, and 449 people died from H1N1. As a result of this outbreak, legislation was passed which required school-aged children to obtain pertussis immunization. e) Other State Requirements . The sponsors cite the state of Washington as an example of a state that changed the requirements for obtaining PBE. On May 2011, legislation was signed in Washington to require a licensed health care provider to sign the Certificate of Exemption for a parent or guardian to exempt their child from school and child care immunization requirements. Similar to the requirements in this bill, the signature of a health care provider verifies that the parent or guardian was provided information about the benefits and risks of immunization. f) Studies Submitted by the Opposition . In stressing that this bill would have a negative impact on families, the opponents to this bill submitted two studies which they claim prove 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 the questionnaire; the majority of responding pediatricians reported an increase in parental vaccine safety concerns and refusals. More than 30% 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. AB 2109 Page 8 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 1004 randomly selected members of AAP members in Illinois. The findings of the 2005 study are the following: 54% faced total vaccine refusal during a 12-month period; pediatricians cited safety concerns as a top reason for parent refusal; 39% said they would dismiss a family for refusing all vaccinations; and, 28% said they would dismiss a family for refusing select vaccines. The 2005 study further pointed out that pediatrician dismissers were not significantly different from nondismissers with respect to age, sex, and number of years in practice. Pediatrician dismissers were also more likely than nondismissers to view traditional vaccines (diphtheria and tetanus toxoids and acellular pertussis; inactivated poliovirus; Haemophilus influenzae type b; measles, mumps, and rubella) as "extremely important," but they were no more likely to view newer vaccines (7-valent pneumococcal conjugate, varicella-zoster virus, hepatitis B) as "extremely important." The 2005 Study recognizes that the practice of family dismissal needs further study to examine its actual impact of vaccination rates, access to care, and doctor-patient relations. 3)SUPPORT . The AAP, CMA, and the Health Officers Association of California (HOAC) are the sponsors of this bill. They 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. AB 2109 Page 9 The California Maternal, Child and Adolescent Health Directors, the California School Health Centers Association, March of Dimes, and the California Black Health Network also state in support that this measure 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. 4)OPPOSITION . In opposition, the Pacific Justice Institute states that existing law provides a reasonable process for exemptions from mandated student vaccinations. This bill changes the current approach and inserts more bureaucracy into intimate medical decisions. The 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 undue burden on parents, discriminates against families utilizing complementary and alternative medicine; and promotes more vaccine use and profit from the pharmaceutical industry. 5)OPPOSE UNLESS AMENDED . The California Naturopathic Doctors Association (CNDA) has taken an oppose unless amended position and requests that this measure be amended to include naturopathic doctors (NDs) as one of the health care practitioners that can provide a consultation to the parent or guardian of a child subject to the requirements regarding the benefits and risks of immunization. CNDA states that NDs are licensed primary care providers in California who practice integrative medicine, trained in both conventional and natural approaches to medicine. NDs attend four-year post graduate medical schools with federally-recognized accreditation and are trained in the same medical sciences as MDs and doctors of osteopathic medicine, and their medical education is greater than NPs and PAs who are included in this bill as health care providers authorized to provide the required letter. Additionally, ND licensure includes the ability to prescribe and administer vaccines. Washington state law, which is the basis for this bill, also allows NDs to give the consultation AB 2109 Page 10 and sign the required forms. 6)RELATED LEGISLATION . AB 2064 (V. Manuel Pérez), pending in this Committee, requires 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. 7)PREVIOUS LEGISLATION . a) SB 614 (Kehoe) Chapter 123, Statutes of 2011, allows 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. b) 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 seven through 12 receive a TDaP booster prior to admittance to school. c) 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. d) 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 AB 2109 Page 11 development center. SB 1179 died in Senate Health Committee. e) 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. f) 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. g) 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. 8)DEFINTION OF HEALTH PRACTITIONERS . a) Osteopathic Physicians and Surgeons . Established by the Osteopathic Initiative Act of 1922, osteopathic physicians and surgeons practice medicine that emphasizes the interrelationship between the structures and functions of the body and recognizes the body's ability to heal itself. Osteopathic physicians and surgeons have similar scope of practice as physicians and surgeons in California. This bill should be amended to include osteopathic physicians and surgeons in the definition of health care practitioners. b) Naturopathic Doctors . Existing law under the Naturopathic Doctors Act (Act) authorizes naturopathic doctors to furnish or order drugs, including Schedule III through Schedule V controlled substances under the California Controlled Substances Act. The furnishing or ordering of controlled substances by an ND must occur under AB 2109 Page 12 physician and surgeon supervision. The Act further provides that physician and surgeon supervision shall not require physical presence of the physician but includes collaboration on the development of standardized procedures, approval of the standardized procedures or availability by telephonic contact at the time of patient examination by the ND. As such, it is within the scope of an ND, under the supervision of physician, to administer immunizations. A parent who is given advice on the risks and benefits of vaccines and subsequently decides to immunize his or her child could certainly obtain immunization for the child not just from physicians and surgeons but also NPs, and PAs and NDs who are under physician and surgeon supervision. It should be noted that the Washington statute that is the basis of this bill includes NDs in the list of health care practitioners who could provide immunization information and sign the required written statement. In the same manner, should NDs who are under physician and surgeon supervision be included in the list of health practitioners who could provide immunization information and sign the written statement required by this bill? REGISTERED SUPPORT / OPPOSITION : Support American Academy of Pediatrics (cosponsor) California Medical Association (cosponsor) Health Officers Association of California (cosponsor) BayBio California Black Health Network California Hepatitis C Task Force California Immunization Coalition California Maternal, Child and Adolescent Health Directors California Pharmacists Association California School Health Centers Association California State Association of Counties Children's Healthcare is a Legal Duty, Inc. Children's Hospital Los Angeles Children's Specialty Care Coalition Kaiser Permanente March of Dimes California Chapter AB 2109 Page 13 National Meningitis Association Northeast Valley Health Corporation San Francisco Department of Public Health San Francisco Immunization Coalition South Los Angeles Health Projects Tracy Unified School District Opposition Association of American Physician and Surgeons (Tucson, AZ) California Right to Life Committee Canary Party CHERISH Foundation Child and Family Protection Association CORE Sacramento Exchange Club of Culver City Families for Early Autism Treatment Health Advocacy in the Public Interest Maher Insurance and Financial Services National Vaccine Information Center (Vienna, VA) Pacific Justice Institute Parental Rights.Org (Purcellville, VA) Private School Advocacy Center (Purcellville, VA) San Francisco Institute for Hyperbaric Medicine Numerous individuals Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916) 319-2097