BILL ANALYSIS                                                                                                                                                                                                    �






                             SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:       AB 2009
          AUTHOR:        Galgiani
          AMENDED:       May 31, 2012
          HEARING DATE:  June 6, 2012
          CONSULTANT:    Rubin

           SUBJECT  :  Communicable disease: influenza vaccinations.
           
          SUMMARY  :  Deletes the requirement that local agencies receiving 
          influenza (flu) vaccine from the Department of Public Health 
          (DPH) prioritize vaccine provision to persons 60 years of age 
          and older, and instead requires DPH to provide guidance to those 
          local agencies as to whether one or more population groups shall 
          have priority for the vaccine.

          Existing law:
          1.Establishes the Immunization Branch within DPH to provide 
            leadership and support to public and private sector efforts to 
            protect the population against vaccine-preventable diseases.

          2.Requires DPH to provide appropriate flu vaccine to local 
            government or private, nonprofit agencies at no charge in 
            order that the agencies may provide the vaccine at a minimal 
            cost, at accessible locations, and in order of priority, first 
            for all person 60 years of age or older and then to any other 
            high-risk groups identified by the United States Public Health 
            Service.

          3.Requires that administration of the flu vaccine be performed 
            by a physician, a registered nurse, or a licensed vocational 
            nurse acting within the scope of their professional practice 
            acts, and requires that a registered nurse or licensed 
            vocational nurse demonstrate satisfactory familiarity with 
            specified immunization procedures to a supervising physician.

          4.Permits physicians, nurses, physician assistants, medical 
            assistants, and pharmacists to administer immunizations under 
            specified circumstances.

          This bill:
          1.Finds and declares that current law related to prioritization 
            for influenza vaccines is outdated and needs to be updated to 
            reflect current federal Centers for Disease Control and 
                                                         Continued---



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            Prevention (CDC) recommendations, that CDC currently 
            recommends annual seasonal influenza vaccination for all 
            persons six months of age and older, that children have the 
            highest rates of influenza infection and are the major vectors 
            for transmission of the virus to adults, and that eligible 
            low-income and uninsured children can access vaccine at no 
            cost through the Vaccine for Children Program.

          2.Deletes the requirement that local agencies receiving flu 
            vaccine from DPH prioritize the provision of vaccine first to 
            persons 60 years of age and older and then to other high-risk 
            groups, and instead requires DPH to provide guidance to local 
            agencies as to whether one or more population groups shall 
            have priority for the vaccine.

          3.Requires that the guidance provided by DPH to local agencies 
            be developed out of consideration of CDC recommendation or 
            other criteria and with the goal of ensuring that the 
            vaccination program is efficient and effective in meeting 
            public health goals.

          4.Allows DPH to issue guidance to local agencies without taking 
            regulatory action under the Administrative Procedure Act.

          5.Deletes the requirement that flu vaccine administration be 
            performed by specified health care professionals and the 
            requirement that a registered nurse or licensed vocational 
            nurse must demonstrate satisfactory familiarity with specified 
            immunization procedures to a supervising physician.

           FISCAL EFFECT  :  The Assembly Committee on Appropriations 
          analysis of this bill indicates negligible state costs.

           PRIOR VOTES  :  
          Assembly Health:    18- 0
          Assembly Appropriations:17- 0
          Assembly Floor:     73- 0
           
          COMMENTS :  
           1.Author's statement.  According to the author, the CDC 
            recommends annual seasonal influenza vaccines for all 
            individuals ages 6 months and older. Children have the highest 
            rate of influenza infection and school-aged children are the 
            major vectors for influenza transmission that spread the virus 
            to adults and the elderly. Over the past few years, the use of 
            free vaccines by people over 60 years of age has been 




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            declining due to Medicare coverage while use by people under 
            the age of 18 has been increasing. Last year, the state had 
            over 90,000 unused flu vaccines; it is our job to see that flu 
            vaccines are made available to those in need of the assistance 
            and those at risk.

          2.Influenza.  According to the CDC's website, the flu is a 
            contagious respiratory illness caused by influenza viruses 
            that infect the nose, throat, and lungs. It can cause mild to 
            severe illness - often with symptoms including fever, chills, 
            cough, sore throat, runny or stuffy nose, muscle or body 
            aches, headaches, fatigue, vomiting, and diarrhea - and at 
            times can lead to death. Flu viruses spread mainly when 
            droplets made by infected people coughing, sneezing, or 
            talking land in the mouths or noses of people nearby; less 
            often, a person might also get flu by touching something with 
            flu virus on it and then touching their own mouth, eyes, or 
            nose. The flu can typically be passed to someone beginning a 
            day before the infected person is symptomatic and up to five 
            to seven days after becoming sick.

          3.Flu vaccine.  The CDC's website indicates that the single best 
            way for an individual to prevent the flu is to get a flu 
            vaccine each season. There are two types of flu vaccines: flu 
            shots of inactivated vaccines that contain killed viruses and 
            are given with a needle, and the nasal-spray flu vaccine that 
            is made with live, weakened viruses and is given as a nasal 
            spray (sometimes called LAIV for Live Attenuated Influenza 
            Vaccine). While there are many influenza viruses, the seasonal 
            flu vaccine protects against the three viruses that research 
            suggests will be most common. About two weeks after 
            vaccination, antibodies develop that protect against influenza 
            virus infection. Variability in the nature and use of the flu 
            vaccine can contribute to the flu's unpredictability: the 
            CDC's website indicates that the flu's severity can vary 
            widely from one season to the next depending on which flu 
            viruses are spreading, how much flu vaccine is available, when 
            vaccine is available, how many people get vaccinated, and how 
            well the flu vaccine is matched to flu viruses that are 
            causing illness.

          4.Recommended flu vaccine use.  According to a CDC press 
            release, the Advisory Committee on Immunization Practices 
            (ACIP), which advises the CDC on vaccine issues, voted in 
            February 2010 to expand the recommendation for annual 




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            influenza vaccination to include all people ages 6 months or 
            older. The vote took place against a backdrop of incremental 
            increases in the numbers and groups of people recommended for 
            influenza vaccination in years past, and lessons learned from 
            the world's then-ongoing first flu pandemic in 40 years - the 
            2009 H1N1 flu pandemic. On their website, the World Health 
            Organization defines a pandemic as the worldwide spread of a 
            new disease; early outbreaks of flu caused by a new H1N1 flu 
            virus were first detected in North America in April 2009, and 
            by February 2010, the virus had rapidly spread to reach most 
            countries in the world. According to the DPH website, 596 
            deaths in California were attributable to the 2009 H1N1 virus 
            by August 28, 2010. The new CDC recommendations of 2010 were 
            intended to remove barriers to influenza immunization and 
            signal the importance of preventing the flu across the entire 
            population. While CDC advocates for universal vaccination of 
            anyone over 6 months of age, the CDC website indicates that it 
            is especially important that certain people get vaccinated 
            either because they are at high risk of having serious 
            flu-related complications or because they live with or care 
            for people at high risk for developing flu-related 
            complications, including children younger than 5 and 
            especially those younger than 2 years old, adults 65 years of 
            age or older, and people with specified medical conditions 
            such as asthma, heart disease, and chronic lung disease.

          5.Flu vaccination program for older adults.  California's 
            program, which would be amended by this bill, was designed to 
            use voluntary assistance from public or private sectors in 
            administering flu vaccines. DPH provides participating local 
            governmental or private nonprofit agencies flu vaccine at no 
            charge in order for the agencies to provide the vaccine for no 
            more than two dollars per person to offset administrative 
            costs. Agencies are tasked with providing flu vaccine to 
            individuals in all high-risk groups, but first to those who 
            are 60 years and older. According to DPH, over the last 
            decade, the pattern of flu vaccine administration under this 
            program has shifted toward younger people: for example, in the 
            2000-01 season vaccine was administered to 15,456 people ages 
            18 years and less, 146,722 people ages 19 to 59 years, and 
            546,047 people of age 60 or greater; by contrast, in the 
            2010-11 season, vaccine was administered to 121,675 people 
            aged less than 18 years, 315,512 people aged 19-59 years, and 
            165,243 people of age 60 or greater. DPH indicates that the 
            increase in the number of individuals under the age of 60 who 
            have received the flu vaccine is consistent with the expansion 




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            in age groups prioritized in federal recommendations to be 
            immunized against influenza in the last decade.

          6.Related legislation.  AB 2109 (Pan) adds to existing 
            requirements, that allow a child to be exempt from a school's 
            immunization requirements because immunization is contrary to 
            the child's parent's or guardian's beliefs, statements signed 
            by a health care practitioner and the parent or guardian 
            indicating the provision and receipt of information regarding 
            the benefits and risks of immunization. AB 2109 is pending in 
            the Senate Health Committee.

          7.Prior legislation.  AB 2064 (V. Manuel P�rez) of 2011 would 
            have required health plans and insurers to reimburse 
            physicians and physician groups for specified costs related to 
            the administration of vaccines. AB 2064 was held on suspense 
            in the Assembly Appropriations Committee.
            
            AB 699 (Chan), Chapter 589, Statutes of 2006, requires a 
            manufacturer or distributer of the influenza vaccine, or a 
            nonprofit health plan that exclusively contracts with a single 
            medical group in a specified geographic area to provide 
            medical services to its enrollees, to report information about 
            the supply of the vaccine to the Department of Health Services 
            (DHS, now DPH) upon notice from DHS.

            SB 1220 (Midgen) of 2006 would have created within DHS an 
            influenza vaccine purchasing and distribution program for 
            smaller physician practices in order to facilitate the timely 
            distribution of the vaccine to the public, and would have 
            authorized the DHS to recover all costs from the sale of the 
            vaccine. SB 1220 was vetoed.

            SB 1711 (Ortiz) of 2006 would have required DHS or its 
            contractor to evaluate the effectiveness of distributing 
            vaccines to local governmental and private nonprofit agencies 
            and report its findings to the Legislature. SB 1711 was held 
            on suspense in the Assembly Appropriations Committee.

            AB 2620 (Wyland) of 2002 would have required an elevated level 
            of state funding for the provision of flu vaccines during the 
            2003-04 flu season, and would have required DHS to conduct a 
            study of existing flu vaccination practices and the increased 
            occurrence of short-term flu vaccine shortages and report its 
            findings to the Legislature. AB 2620 failed passage in the 




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            Assembly Health Committee.
            
          8.Support.  The American Academy of Pediatrics indicates that 
            children have a higher rate of influenza infection than any 
            other age group, are more contagious than adults, and often 
            spread the disease to vulnerable groups including the elderly 
            and infants, who are too young to receive the vaccine. The 
            California Academy of Family Physicians states that 
            unvaccinated children can contract and spread dangerous or 
            life-threatening diseases and lessen the effect of "herd 
            immunizations" in the population as a whole. The California 
            School Nurses Association adds that for many school-aged 
            children, seasonal influenza is a yearly occurrence that 
            causes school absences that interfere with learning and the 
            loss of work days for their parents/guardians; it is also not 
            unusual for children to return to school early and spread the 
            virus to their friends, teachers, and staff. The California 
            State PTA and the Greater Los Angeles African American Chamber 
            of Commerce concur that seasonal flu in children can cause 
            absenteeism from school and impair learning, and ultimately 
            impact the entire community by disrupting work and child care 
            arrangements. MedImmune states that the requirement to 
            prioritize free flu vaccine for seniors in California was 
            added in the 1970s when Medicare did not cover flu vaccines 
            and the vaccine was not as readily available to seniors at 
            their local pharmacy or physician's office, but that now, 
            seniors are able to obtain a free flu vaccine fairly easily 
            while children do not always have the same coverage options 
            and as seniors and can benefit from free flu vaccine 
            administered by a school nurse or a clinic organized by their 
            local health department. The American Federation of State, 
            County, and Municipal Employees adds that this bill would 
            align California's prioritization of flu vaccine 
            administration with recommendations from ACIP.

          9.Author's amendment. This bill allows DPH to provide guidance 
            to local agencies as to whether one or more population groups 
            shall have priority for the provided flu vaccine, and requires 
            DPH to consider the influenza recommendations of ACIP or other 
            criteria. In order to provide guidance for local agencies in 
            the absence of DPH-issued guidance, the author has agreed to 
            add the following to the end of Health and Safety Code Section 
            120392.3 (b): "In the absence of guidance from the department, 
            local agencies shall be guided by the influenza 
            recommendations of ACIP."





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          10.Technical amendments.  To maintain consistency, the committee 
            staff recommends:
               a.     On Page 6, Line 9, after "Immunization Practices", 
                 insert "(ACIP)";
               b.     On Page 6, Line 20, strike "United States Public 
                 Health Service", and insert "ACIP";
               c.     On Page 6, Line 39, strike out "to a person 60 years 
                 of age or older or to members of high-risk groups 
                 identified by the United States Public Health Service"; 
                 and
               d.     On Page 6, Line 16, strike out "pneumococcal", and 
                 insert "pneumonia".
          
           SUPPORT AND OPPOSITION  :
          Support:  American Academy of Pediatrics California
                    American Federation of State, County, and Municipal 
               Employees
                    California Academy of Family Physicians
                    California Pharmacists Association
                    California School Employees Association
                    California School Health Centers Association
                    California School Nurses Organization
                    California Senior Legislature
                    California State PTA
                    Greater Los Angeles African American Chamber of 
               Commerce
                    MedImmune
                    Service Employees International Union California
                    5 individuals

          Oppose:   None received.

                                      -- END --