BILL ANALYSIS SENATE HEALTH COMMITTEE ANALYSIS Senator Elaine K. Alquist, Chair BILL NO: AB 354 A AUTHOR: Arambula B AMENDED: April 28, 2009 HEARING DATE: June 17, 2009 3 CONSULTANT: 5 Orr/ 4 SUBJECT Health: immunizations SUMMARY Deletes certain age limits for specified childhood immunizations required for admission to specified schools or child care centers, and requires the Department of Public Health (DPH) to consider the immunization recommendations of the American Academy of Family Physicians. CHANGES TO EXISTING LAW Existing law: States legislative intent to provide a means for specified age groups to achieve total immunization against certain childhood diseases, to the extent that funds are appropriated for this purpose from the annual Budget Act. 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 Continued--- STAFF ANALYSIS OF ASSEMBLY BILL 354 (Arambula) Page 2 has been fully immunized against the following diseases: Diphtheria, Haemophilus influenzae type b, Measles, Mumps, Pertussis, Poliomyelitis, Rubella, Tetanus, Hepatitis B, and Varicella. Establishes several exceptions to these requirements, based on the age of the child: Haemophilus influenzae type b immunization only applies to children who have not reached the age of four and a half years old. Mumps immunization only applies to children who have not reached the age of seven years old. Pertussis (whooping cough) immunization only applies to children who have not reached the age of seven years old. Hepatitis B immunization is required of all children entering kindergarten after August 1, 1997. Existing law prohibits a governing authority to unconditionally admit any pupil to the 7th grade unless the pupil has been fully immunized, beginning July 1, 1999. Varicella (chickenpox) immunization is required only if a person has not already been admitted into a California public or private school at the kindergarten level or above. Existing law stipulates that Varicella immunization requirements are operative to the extent that funds are appropriated for this purpose from the annual Budget Act and allows DPH to adopt emergency regulations to implement this requirement, as deemed necessary by the Office of Administrative Law for the immediate preservation of the public health or general welfare, to remain in effect for no longer than 180 days. Allows DPH to add any other disease that is consistent with the most current immunization recommendations of the Centers for Disease Control and the American Academy of Pediatrics to their list of required vaccinations. This bill: Requires DPH to additionally consider the recommendations of the American Academy of Family Physicians when adding any other disease to their list of required vaccinations. STAFF ANALYSIS OF ASSEMBLY BILL 354 (Arambula) Page 3 Deletes current exceptions to immunization requirements based on age or grade, specifically for Haemophilus influenzae type b, Mumps, Pertussis, and Varicella. Deletes the requirement that Hepatitis B immunization can only be required of children entering kindergarten after August 1, 1997. By deleting some of these exceptions, the DPH will have the latitude to adopt other regulations regarding immunization requirements for school-age children. Deletes the stipulation that the immunization requirements for Varicella are operative to the extent that funds are appropriated for this purpose from the annual Budget Act. Deletes the provision allowing DPH to adopt emergency regulations to implement the Varicella immunization requirement. FISCAL IMPACT The Assembly Appropriations Committee estimates net savings to the extent this bill reduces future health costs, by increasing immunization efficacy and rates. BACKGROUND AND DISCUSSION According to the author, AB 354 will reduce rates of pertussis infections by allowing DPH to place a pertussis booster vaccine among the necessary vaccinations for students prior to the start of the 7th grade. Existing childhood immunization against pertussis does not provide the lasting immunity needed to control the disease and protect public health. The author asserts that this bill is necessary to DPH's efforts to adopt more updated vaccination requirements that are needed to effectively reduce incidences of this disease. Background Pertussis (whooping cough) is an acute, infectious cough STAFF ANALYSIS OF ASSEMBLY BILL 354 (Arambula) Page 4 illness that is highly communicable and can cause severe disease, particularly among very young children. According to the Centers for Disease Control and Prevention (CDC), pertussis remains endemic in the United States despite routine childhood pertussis vaccination for more than half a century. The CDC asserts that the main reason for the continued circulation of pertussis is that the immunity created by the vaccine can wane approximately 5-10 years after completion of the childhood pertussis vaccination, leaving adolescents and adults susceptible to the disease. The disease is most detrimental in infants less than one year of age, and can be fatal. Older preschool children and school-age siblings who are not fully vaccinated and who develop pertussis can easily become sources of infection for infants. Adults can also transmit pertussis to unvaccinated or incompletely vaccinated infants and young children. In 2005, the first pertussis booster vaccines (referred to as Tdap, a combination of vaccines for tetanus, diphtheria, and pertussis) were licensed in the United States for use in adolescents and adults. Since 2005, Tdap vaccine has been included in DPH's Vaccines for Children (VFC) Program, a federal program that provides recommended immunizations to eligible clients through the age of 18 years. Vaccine recommendations According to the CDC's Advisory Committee on Immunization Practices (ACIP), optimal response to a vaccine depends on multiple factors, including the nature of the vaccine and the age and immune status of the recipient. Recommendations for the age at which vaccines are administered are influenced by age-specific risks for disease, age-specific risks for complications, ability of persons of a certain age to respond to the vaccine, and potential interference with the immune response by passively transferred maternal antibody. Vaccines are recommended for members of the youngest age group at risk for experiencing the disease for whom efficacy and safety have been demonstrated. ACIP consists of 15 experts selected by the Secretary of the United States Department of Health and Human Services to provide advice and guidance to the Secretary, the STAFF ANALYSIS OF ASSEMBLY BILL 354 (Arambula) Page 5 Assistant Secretary for Health, and the CDC on the most effective means to prevent vaccine-preventable diseases. ACIP includes representation by a variety of national organizations, including the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) as well as other federal departments, such as the Centers for Medicare and Medicaid Services, Food and Drug Administration, and the National Vaccine Program Office. The overall goals of the ACIP are to provide advice which will assist in reducing the incidence of vaccine preventable diseases, and to increase the safe usage of vaccines and related biological products. ACIP, in conjunction with AAP and AAFP, publishes a schedule of recommended childhood and adolescent immunizations and revises it annually. ACIP is the only entity in the federal government which makes such recommendations. American Academy of Family Physicians The American Academy of Family Physicians is one of the largest national medical organizations, representing more than 94,000 family physicians, family medicine residents, and medical students nationwide. Founded in 1947, its mission has been to preserve and promote the science and art of family medicine and to ensure high-quality, cost-effective health care for patients of all ages. Related legislation SB 158 (Wiggins) 2009 requires health care service plan contracts and health insurance policies that provide coverage for cervical cancer treatment or surgery to also provide coverage for a human papillomavirus (HPV) vaccine. Pending in the Assembly Appropriations Committee. SB 249 (Cox) 2009 requires DPH to include children who are at least 11 years of age in any meningococcal disease public awareness campaign it implements. Pending in the Assembly Health Committee. AB 977 (Skinner) 2009 requests the California Pharmacists Association to provide information to specified legislative committees on the status of immunization protocols between independent pharmacists and physicians. Pending in the Assembly Health Committee. AB 1021 (Emmerson) 2009 was originally nearly identical to this bill, and was sponsored by DPH. This bill was STAFF ANALYSIS OF ASSEMBLY BILL 354 (Arambula) Page 6 substantively amended to deal with an unrelated topic. AB 1201 (V. Manuel Perez) 2009 requires 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. Held on suspense in the Assembly Appropriations committee. AB 1251 (Saldana) 2009 required the Immunization Branch of DPH, after consulting with the Office of Multicultural Health, to create a public outreach campaign, including the creation of an informational internet website, to educate citizens of the state with Asian, Southeast Asian, or Pacific Islander backgrounds on the importance of immunization against hepatitis B. Gutted and amended into an unrelated bill. Prior legislation SB 533 (Yee) 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. Vetoed by the governor, who claimed that a mandate for this vaccination was not necessary. SB 676 (Ridley-Thomas) 2007 would have required pupils entering the 7th grade to be fully immunized against pertussis. Required the DPH to maintain a list of diseases and conditions for which immunization is required prior to entry into any private or public elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center. Permited the DPH to modify the list at any time and requires the DPH to annually review and modify immunization requirements for pupils. Exempted modification of the list established by the DPH from administrative regulation and rulemaking requirements under existing law. Held on suspense in Assembly Appropriations Committee. SB 1179 (Aanestad) 2008 would have deleted DPH's authority to add diseases to the list of those requiring STAFF ANALYSIS OF ASSEMBLY BILL 354 (Arambula) Page 7 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. Set for hearing in the Senate Health Committee, but was pulled at the author's request. AB 16 (Evans) 2008 as introduced by Assemblymember Hernandez in 2007, would have required all female students to be vaccinated for HPV prior to school admission. The bill was amended before it passed the Assembly to instead establish a process for California to adopt ACIP vaccine recommendations as a requirement for admission to schools and day care centers. In the Senate, the bill changed authorship to Assemblymember Evans and the bill was amended to require health plans and health insurers to provide coverage for HPV vaccine. Vetoed by the governor, citing concerns over the cost of a new mandate. AB 2580 (2008) was nearly identical to this bill, but added a mandate requiring pupils entering the 7th grade to be fully immunized against pertussis. Held on suspense in the Senate Appropriations Committee. AB 106 (Berg) Chapter 378, Statutes of 2007, requires a general acute care hospital to offer immunizations for influenza and pneumococcal disease to its inpatients aged 65 years or older, each year commencing October 1 to the following April 1, inclusive, if it has the vaccine in its possession, prior to the patients' discharge. AB 1429 (Evans) 2007 preceded and was substantially similar to the final version of AB 16 (Evans, 2008). Vetoed by the governor, with a similar veto message. AB 576 (Wolk) Chapter 329, Statutes of 2006 requires, among other things, DPH to submit by January 31, 2008, a sustainability plan for full funding of a statewide immunization information system, as specified. Arguments in support Supporters such as the California Medical Association claim this bill will make statutory vaccination requirements more consistent with current federal recommendations for childhood immunizations. The California Academy of Family Physicians argues that pediatric vaccinations are some of STAFF ANALYSIS OF ASSEMBLY BILL 354 (Arambula) Page 8 the safest and most cost-effective public health inventions of this century. The California Immunization Coalition claims this bill could lead to Medi-Cal savings of over $16 million, not including savings in the private sector. AFSCME believes this bill will help to ensure that schools are healthy and disease free. Arguments in opposition The California Resource Family Impact opposes this bill on the grounds that the American Academy of Family Physicians recommends vaccinations against the Human Papillomavirus (HPV) for 11-year old girls. They believe that passage of this bill will lead to the HPV vaccinations being mandated for all girls. They believe that legislative intent is to not support mandating HPV vaccines for girls, based on the failure of AB 16 to become law. PRIOR ACTIONS Assembly Floor: 74-2 Assembly Appropriations:11-2 Assembly Health: 19-0 COMMENTS 1. State regulations for vaccines According to DPH, additional vaccines can be required for pupils in California either through statute or regulation. Any vaccine may be added through statute. Any vaccine recommended by ACIP and not otherwise limited by H&S Code, Section 120335, may be added through regulations promulgated by DPH after consultation with the California Department of Education (CDE). It is important to note that the bill itself does not directly require DPH to implement a pertussis booster shot prior to entering 7th grade. The bill seeks to remove the stipulation that the pertussis vaccine can only be required in children younger than seven (7) years of age. By deleting this age restriction in statute, DPH will have more flexibility through the regulatory process in implementing childhood immunization schedules in the state. 2. Suggested technical amendment STAFF ANALYSIS OF ASSEMBLY BILL 354 (Arambula) Page 9 On page 2, lines 22-24, amend as follows: (10) Varicella (chickenpox).
This paragraph shall be operative only to the extent that funds for this purpose are appropriated in the annual Budget Act.POSITIONS Support: American Academy of Pediatrics American Federation of State, County, and Municipal Employees California Academy of Family Physicians California Immunization Coalition California Medical Association California School Nurses Organization California State PTA GlaxoSmithKline Oppose: Capitol Resource Family Impact -- END --