BILL ANALYSIS                                                                                                                                                                                                    Ó



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          Date of Hearing:  April 10, 2012

                            ASSEMBLY COMMITTEE ON HEALTH
                              William W. Monning, Chair
                   AB 2009 (Galgiani) - As Amended:  March 29, 2012
           
          SUBJECT  :  Communicable disease: influenza vaccinations.

           SUMMARY :  Includes persons who are under 18 years of age among 
          those who have priority to receive flu vaccine.  Specifically, 
           this bill  :  

          1)Includes persons who are not more than 18 years of age among 
            those who have priority to receive flu vaccine under a flu 
            vaccine program administered by the Department of Public 
            Health (DPH) for older adults (60 years or older).

          2)Finds and declares the importance of preventing influenza 
            infection among school-aged children and, that current law 
            related to prioritization for influenza vaccines is outdated 
            and needs to be updated to reflect current recommendations by 
            the federal Centers for Disease Control and Prevention (CDC).

           EXISTING LAW  :  

          1)Establishes the Immunization Branch within DPH to protect 
            Californians against vaccine preventable diseases.

          2)Requires DPH to provide appropriate flu vaccine to local 
            governmental or private, nonprofit agencies at no charge in 
            order that the agencies may provide the vaccine, at a minimal 
            cost, at accessible locations in the order of priority first, 
            for all persons 60 years of age or older in this state and 
            then to any other high-risk groups identified by the United 
            State Public Health Service.  Requires DPH and the State 
            Department of Aging to prepare, publish, and disseminate 
            information regarding the availability of the vaccine and the 
            effectiveness of the vaccine in protecting the health of older 
            persons.

          3)Establishes the federal Vaccine for Children Program that 
            offers vaccines at no cost for eligible children.

           FISCAL EFFECT  :  This bill has not yet been analyzed by a fiscal 
          committee.








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           COMMENTS  :

           1)PURPOSE OF THIS BILL  .  According to the author, "while 
            children are the most vulnerable to catching the flu, they are 
            also the ones who suffer the most from it.  Catching the flu 
            often leads to many unnecessary school absences, missed work 
            days for parents/caregivers and related medical expenses."  
            This bill is necessary to ensure flu vaccination of children 
            becomes a priority.  To illustrate the importance of flu 
            vaccination, the author cites a Japanese influenza vaccination 
            program aimed at protecting school children and reducing the 
            rate of transmission of infection within the community, 
            particularly to the elderly and those with chronic, high-risk 
            conditions.  In this program, the vaccination of Japanese 
            children prevented about 37,000 to 49,000 deaths per year, or 
            about one death for every 420 children vaccinated.  As the 
            vaccination of school children was discontinued, mortality 
            rates in Japan increased.
           2)BACKGROUND  .  

              a)   Influenza .  According to DPH's Website, influenza is a 
               contagious respiratory illness caused by influenza viruses, 
               and can cause mild to severe illness, and at times can lead 
               to death. The best way to prevent influenza is by getting a 
               flu vaccination each year.   The CDC recommends a yearly 
               flu vaccine for everyone six months of age and older as the 
               first and most important step in protecting against this 
               serious disease. While there are many different flu 
               viruses, the flu vaccine is designed to protect against the 
               three main flu strains that research indicates will cause 
               the most illness during the flu season.  The importance of 
               obtaining a flu vaccine was highlighted in 2009 with the 
               H1N1 outbreak in the United States.  H1N1 is a new strain 
               of the influenza virus that first appeared in April 2009 in 
               the United States and spread worldwide.  The symptoms of 
               H1N1 are similar to the regular human seasonal flu 
               infection.  According to DPH's Website, by December 2009, 
               8,003 people in California were hospitalized, and 449 
               people died from H1N1.   

             Driven by the H1N1 pandemic, in February 2010, the Advisory 
               Committee on Immunization Practices, which advises the CDC 
               on vaccine issues, voted to recommend that all people aged 
               six months and older must obtain a flu vaccine (universal 
               recommendation for vaccination).  However, the CDC also 
               points out that while everyone should get flu vaccine each 







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               flu season, it is especially important that the following 
               groups get vaccinated either because they are 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: pregnant women; children younger 
               than five; but especially children younger than two years 
               old, people 50 years of age and older; people of any age 
               with certain chronic medical conditions; people who live in 
               nursing homes and other long-term care facilities; and, 
               people who live with or care for those at high risk for 
               complications from flu, as specified.

              b)   Hospitalizations and Deaths Due to Influenza.   
               Protection against influenza virus is important because of 
               serious complications, including death, which may arise.  
               According to CDC, during the 2010-11 influenza season, 
               influenza activity first began to increase in the 
               southeastern United States in November and peaked 
               nationally in early February.  During this season, a higher 
               rate of hospitalization was observed for persons aged e 65 
               years, and lower hospitalization rates were observed in 
               younger populations than during the pandemic year.  There 
               were 115 deaths associated withc) laboratory-confirmed 
               influenza virus infections occurring from October 3, 
               2010-May 21, 2011 among children aged <18 years during the 
               2010-11 influenza season that were reported to CDC.  These 
               deaths were reported from 34 states, Chicago, and New York 
               City.  The mean and median ages of children who died were 
               6.8 years and 5.7 years, respectively; 16 children were 
               aged <6 months, 17 were aged 6-23 months, 21 were aged 2-4 
               years, 32 were aged 5-11 years, and 29 were aged 12-17 
               years.  For comparison, during the 2009 pandemic, 348 
               pediatric deaths were reported to CDC during April 15, 2009 
               - October 2, 2010.  Before the pandemic, 67 
               influenza-associated pediatric deaths were reported for the 
               2008-09 season, and 88 deaths were reported for the 2007 - 
               08 season.  Furthermore, the CDC also included cumulative 
               hospitalization rates (per 100,000 population) because of 
               influenza.  For example, the cumulative hospitalization 
               rate for October 1, 2010-April 30, 2011, was 43.8 among 
               children aged 0-4 years, 8.9 among children aged 5-17 
               years, 11.1 among adults aged 18-49 years, 22.5 among 
               adults aged 50-64 years, and 65.0 among adults aged e65 
               years.
              d)   Flu Vaccine Program for Older Adults  .  This program was 
               designed to utilize voluntary assistance from public or 







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               private sectors in administering the vaccines.  
               Participating entities may charge and retain a fee not 
               exceeding $2 per person to offset administrative operating 
               costs.  Additionally, DPH is allowed to seek and utilize 
               available funds for the cost of the vaccine and its 
               administration, including reimbursement under the Medi-Cal 
               program to the extent permitted by federal law.  
               Participating entities are also immune from liability for 
               any injury caused by an act or omission in the 
               administration of the vaccine or other immunizing agent to 
               a person 60 years or older or to members of high-risk 
               groups, as specified. 

             Each year a request for bids is open to all manufacturers and 
               distributors of influenza vaccine and the amount of vaccine 
               that is purchased by DPH depends on the prices contained in 
               the winning bids compared to the amount of state funds 
               available for this purpose.  DPH allocates state-purchased 
               influenza vaccine to local health departments based on 
               their population distribution and historical vaccine usage. 
                Local health departments then use or distribute their 
               vaccine allocations at the local level.  According to DPH, 
               the following are the number of vaccines ordered for 
               distribution to local health departments for the most 
               recent flu seasons: 2011-12: 285,950 doses, 2010-11: 
               790,000 doses, and in 2010-09, 684,000 doses.  Since DPH 
               anticipates the number of doses that local health 
               departments will want to administer every flu season, DPH 
               orders more vaccine that actually distributed.  The table 
               below shows vaccines that are ordered and distributed to 
               local health departments.  It should be noted that from 
               year to year, thousands of flu vaccines remain unused.

                 Administration by Age Group, 2000-2011 Influenza Seasons

             ------------------------------------------------------------- 
            |Season | <18  | 19-59  |  >60   | Total  | * Total  |   **   |
            |       |years | years  | years  | doses  |  doses   |Approx. |
            |       |      |        |        |Ordered |administer| Unused |
            |       |      |        |        |        |    ed    | Doses  |
            |-------+------+--------+--------+--------+----------+--------|
            |2000-20|15,456|146,722 |546,047 |749,226 | 709,292  | 39,934 |
            |01     |      |        |        |        |          |        |
            |-------+------+--------+--------+--------+----------+--------|
            |2001-20|16,980|159,128 |536,782 |741,828 | 714,790  | 27,038 |
            |02     |      |        |        |        |          |        |







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            |-------+------+--------+--------+--------+----------+--------|
            |2002-20|25,807|174,639 |404,919 |687,879 | 605,407  | 82,472 |
            |03     |      |        |        |        |          |        |
            |-------+------+--------+--------+--------+----------+--------|
            |2003-20|69,058|196,598 |361,291 |668,715 | 626,947  | 41,768 |
            |04     |      |        |        |        |          |        |
            |-------+------+--------+--------+--------+----------+--------|
            |2004-20|61,654|149,069 |380,072 |706,480 | 628,442  | 78,038 |
            |05     |      |        |        |        |          |        |
            |-------+------+--------+--------+--------+----------+--------|
            |2005-20|90,149|199,979 |368,593 |767,690 | 659,727  |107,963 |
            |06     |      |        |        |        |          |        |
            |-------+------+--------+--------+--------+----------+--------|
            |2006-20|118,72|213,034 |286,066 |688,318 | 624,576  | 63,742 |
            |07     |  6   |        |        |        |          |        |
            |-------+------+--------+--------+--------+----------+--------|
            |2007-20|121,34|232,591 |245,663 |659,042 | 599,598  | 59,444 |
            |08     |  4   |        |        |        |          |        |
            |-------+------+--------+--------+--------+----------+--------|
            |2008-20|75,828|231,640 |204,077 |589,205 | 511,709  | 77,496 |
            |09     |      |        |        |        |          |        |
            |-------+------+--------+--------+--------+----------+--------|
            |2009-20|126,79|219,233 |160,887 |572,681 | 512,305  | 60,376 |
            |10     |  4   |        |        |        |          |        |
            |-------+------+--------+--------+--------+----------+--------|
            |2010-20|121,67|315,512 |165,243 |701,182 | 604,667  |96,515  |
            |11     |  5   |        |        |        |          |        |
             ------------------------------------------------------------- 
            *    Includes doses given to persons whose age was not 
            reported to DPH.
            **   The actual number may be somewhat lower as DPH requests 
            local health departments to report their vaccine inventory 
            each year in March, prior to the end of the current flu 
            season.  This is required to facilitate ordering the following 
            season's flu vaccine which must be done prior to the end of 
            the current flu season. 

              e)   Vaccines for Children Program  .  Vaccination of children 
               remains a high priority both on the state and federal 
               level.  For example, the federal Vaccines for Children 
               Program (VFC Program), officially implemented in October 
               1994, provides vaccines at no cost to children who might 
               not otherwise be vaccinated because of inability to pay.  
               The VFC Program was created by the Omnibus Budget 
               Reconciliation Act of 1993 as a new entitlement program to 
               be a required part of each state's Medicaid plan.  Funding 







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               for the VFC Program is approved by the Office of Management 
               and Budget and allocated through the Centers for Medicare 
               and Medicaid Services to the CDC.  CDC buys vaccines at a 
               discount and distributes them to grantees (state health 
               departments and certain local and territorial public health 
               agencies) which in turn distribute them at no charge to 
               those private physician offices and public health clinics 
               registered as VFC providers.  

             In California, DPH administers the VFC Program.  According to 
               DPH's Website, to qualify, children must be under the age 
               of 19 and one of the following: Medicaid eligible, 
               uninsured, American Indian or Alaska native, or 
               underinsured, as specified.  There is no charge for any 
               vaccines given by a VFC provider to eligible children but 
               there can be other costs associated with a vaccination.  
               For example, participating doctors can charge a standard 
               fee of $17.55 or less to administer each shot but if a 
               family cannot afford the fee per shot, the fee must be 
               waived.  A VFC-eligible child cannot be refused a 
               vaccination due to the parent or guardian's inability to 
               pay for shot administration.   

          3)SUPPORT  .  Supporters such as the California School Nurses 
            Organization, SEIU California and the California Senior 
            Legislature indicate that adding children into the flu vaccine 
            priority list would minimize the spread of influenza to other 
            high risk groups.  The American Academy of Pediatrics points 
            out children have the highest rates of influenza infection, 
            more than any other age group, and this bill would help 
            protect them and the community from the burden of influenza.  
            In their support, MedImmune points out that "the current 
            priority given to seniors for vaccination was added in the 
            1970's when Medicare did not cover flu vaccines and the 
            vaccine was not readily accessible to seniors at their local 
            pharmacy or physician's office.  Unfortunately, children do 
            not always have the same coverage options as seniors and can 
            benefit from free flu vaccines administered by a school nurse 
            or a clinic organized a local health department."   

           4)RELATED LEGISLATION  .  AB 2109 (Pan), pending in this 
            Committee, would specify certain requirements for parents and 
            guardians of school-aged children who wish to seek exemption 
            from immunization requirements.  AB 2064   (V. Manuel Pérez), 
            also pending in this Committee, would require health care 
            service plans and health insurers that provide coverage for 







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            childhood and adolescent immunizations to reimburse physicians 
            of the costs of vaccines, as specified.

           5)PREVIOUS LEGISLATION  .  

             a)   SB 1711 (Ortiz) of 2006, would have required the 
               Department of Health Services (DHS now DPH) or its 
               contractor to evaluate the effectiveness of the current 
               system of distributing vaccines to local governmental and 
               private nonprofit agencies and provide a report to the  
               Legislature by January 1, 2008.  SB 1711 died in the 
               Assembly Appropriations Committee.  

             b)   SB 1220 (Migden) of 2006 would have created an influenza 
               vaccine purchasing and distribution program for smaller 
               physician practices within DHS, and  would have authorized 
               DHS to recover all costs from the sale of the vaccine.  SB 
               1220 was vetoed by then Governor Schwarzenegger who 
               indicated that "SB 1220 would require new, unnecessary 
               bureaucracy within state government, and increase state 
               costs."

             c)   AB 699 (Chan), Chapter 589, Statutes of 2006, requires 
               any manufacturer or distributor of the influenza vaccine, 
               or nonprofit health care service plan that exclusively 
               contracts with a single medical group in a specified 
               geographic area, to provide, or arrange for the provision 
               of, medical services to its enrollees to report specified 
               information regarding the supply of the vaccine upon notice 
               from the DPH. 

           6)POLICY CONSIDERATIONS  .  This bill would include all persons 
            who are not more than18 years of age among those who have 
            priority to receive the flu vaccine.  According to the 
            findings and declarations contained in the bill, the current 
            priority list is outdated and needs to be updated to reflect 
            current recommendation by the CDC.  However, the change in 
            priority sought by this bill is not consistent with current 
            CDC recommendations.  As indicated above, the CDC began urging 
            a universal flu vaccination during the 2010-11 flu season in 
            light of the H1N1 pandemic in 2009-10.  However, even with 
            this universal flu vaccination recommendation, the CDC 
            maintains that certain groups continue to be at high risk of 
            having serious flu-related complications: pregnant women; 
            children younger than five, but especially children younger 
            than two years old; people 50 years of age and older; people 







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            of any age with certain chronic medical conditions; people who 
            live in nursing homes and other long-term care facilities; 
            and, people who live with or care for those at high risk for 
            complications from flu.  If the current priority list is to be 
            amended, should it also include all groups who are considered 
            high-risk?  In the alternative, if listing all high-risk 
            groups invites a change in existing law every time the 
            priority changes, should the DPH instead be authorized to set 
            the priority based on CDC recommendations, or give DPH the 
            flexibility to set the priority when there are no CDC 
            recommendations?

           REGISTERED SUPPORT / OPPOSITION  :  

           Support 
           
          American Academy of Pediatrics
          American Federation of State, County, and Municipal Employees, 
          AFL-CIO
          California Senior Legislature
          California School Health Centers Association
          California School Nurses Organization
          California State PTA
          Greater Los Angeles African American Chamber of Commerce 
          MedImmune, Inc
          SEIU California

           Opposition  

          None on file.
           
          Analysis Prepared by  :    Rosielyn Pulmano / HEALTH / (916) 
          319-2097