BILL ANALYSIS                                                                                                                                                                                                    






                                 SENATE HEALTH
                               COMMITTEE ANALYSIS
                        Senator Elaine K. Alquist, Chair


          BILL NO:       AB 354                                       
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          AUTHOR:        Arambula                                     
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          AMENDED:       April 28, 2009
          HEARING DATE:  June 17, 2009                                
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          CONSULTANT:                                                 
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          Orr/                                                        
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                                     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---



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          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.  




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          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  




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          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  




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          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  




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          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  




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          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  




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          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




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            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


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