BILL ANALYSIS Ó AB 2009 Page 1 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infection among school-aged children and, that current law related to prioritization for influenza vaccines is outdated and needs to be updated to reflect current recommendations by the federal Centers for Disease Control and Prevention (CDC).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. AB 2009 Page 2 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 AB 2009 Page 3 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 AB 2009 Page 4 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 | | | | | | | AB 2009 Page 5 |-------+------+--------+--------+--------+----------+--------| |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 AB 2009 Page 6 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 AB 2009 Page 7 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 AB 2009 Page 8 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