BILL ANALYSIS ------------------------------------------------------------ |SENATE RULES COMMITTEE | AB 52| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ THIRD READING Bill No: AB 52 Author: Portantino (D) Amended: 8/30/10 in Senate Vote: 27 - Urgency SENATE HEALTH COMMITTEE : 5-3, 8/11/10 AYES: Alquist, Strickland, Leno, Negrete McLeod, Pavley NOES: Aanestad, Cedillo, Romero NO VOTE RECORDED: Vacancy ASSEMBLY FLOOR : 68-8, 6/2/09 - See last page for vote SUBJECT : Umbilical Cord Blood Collection Program SOURCE : American College of Obstetricians and Gynecologists, IX/CA DIGEST : This bill requests the University of California (UC) to develop a plan to establish and administer the Umbilical Cord Blood Collection Program (UCBCP) for the purpose of collecting units of umbilical cord blood for public use, as specified, increases the fee for birth certificate copies by $2 to provide funds to implement the UCBCP, and requires the UC to implement the plan, contingent on an unspecified amount of funds being available in the UCBCP Fund (Fund). ANALYSIS : Existing federal law establishes a national umbilical cord blood network and authorizes funding to CONTINUED AB 52 Page 2 collect and maintain human cord blood stem cells for the treatment of patients and for research and also includes directives for umbilical cord blood donation, education and advocacy. Existing state law: 1. Requires the Department of Public Health (DPH), until January 1, 2015, to establish the UCBCP for the purpose of increasing the amount of umbilical cord blood that is donated in the state and added to the national umbilical cord blood inventory. 2. Authorizes the UCBCP, to the extent private or public funds are identified and secured for these purposes, to identify and provide funds for grants or contracts with qualified blood banks that are licensed and accredited to collect and store umbilical cord blood for public transplantation purposes. 3. Permits DPH to implement any additional standards for blood banks, to collect and store umbilical cord blood, through the adoption of regulations. 4. Establishes the Umbilical Cord Blood Collection Program Fund (Fund), consisting of federal, state, and private funds made available for purposes of the program. 5. Requires DPH, contingent upon private funding, to conduct the Umbilical Cord Blood Community Awareness Campaign to provide awareness, assistance, and information regarding umbilical cord blood banking options using brochures, television, print media, radio, the Internet, outdoor advertising, and other media; establish an Internet Web site with specified information; and, undertake public education activities related to umbilical cord blood donation to targeted populations, as appropriate. 6. Requires DPH to provide umbilical cord blood samples to the Birth Defect Monitoring Program, for storage and research, as specified. This bill: CONTINUED AB 52 Page 3 1. Requests UC, by July 1, 2011, to develop a plan to establish and administer the UCBCP for the purpose of collecting units of umbilical cord blood for public use as specified, and deletes DPH's responsibility for administering the program. 2. Expresses intent that UC submit the plan to the health and fiscal committees of the Legislature. 3. Adds $2 to the current fee for certified copies of birth certificates and requires the additional $2 to be paid into the Fund for support of the UCBCP. 4. Provides that funds shall be appropriated for the UCBCP to the extent the plan and implementation of the program are consistent with the goals and intent of the bill. 5. Provides that moneys appropriated for the UCBCP shall be available for encumbrance or expenditure for three fiscal years following the appropriation of the funds. 6. Defines public use of umbilical cord blood as blood units from genetically diverse donors that will be owned by the UC. 7. Requires the inventory to be accessible by the National Registry and other qualified registries and transplant centers, as specified, for transplantation and research uses. 8. Permits UC, for the purpose of implementing cord blood collection goals of the program, to contract with one or more entities that are in compliance with federal guidelines and regulations. 9. Permits UC to use a competitive process to select entities to administer the collection and research objectives of the program, if the UC chooses not to undertake these activities itself. 10.Requires entities selected to bank, bank cord blood units to have, at minimum, an investigational new drug exemption or a biological license from the Federal Drug CONTINUED AB 52 Page 4 Administration. 11.Establishes qualifications for an entity to receive umbilical cord blood units for research, and requires a medical provider or research facility to comply with all applicable state and federal laws with respect to personally identifiable information contained in the inventory. 12.Subjects these entities to existing penalties for violations. 13.Expresses the intent of the Legislature that UC limit fees for access to cord blood units to the reasonable and actual costs of storage, handling, and providing units, as well as for related services, as specified. 14.Expresses the intent of the Legislature that UC: A. Develop a strategy to increase voluntary participation by hospitals in the collection and storage of umbilical cord blood and identify funding sources to offset the financial impact on hospitals. B. Consider a medical contingency response program to prepare for and respond effectively to biological, chemical, or radiological attacks, accidents, and other public health emergencies where victims potentially benefit from treatment. C. Explore the feasibility of operating the program as a self-funding program, including the potential of charging users a reimbursement fee. 15.Permits UC to deny further access to any confidential information maintained by the UC to any person who violates its policies to maintain confidentiality of information, and subject them to a civil penalty of up to $1,000. 16.Sunsets the UCBCP and the $2 additional birth certificate fee on January 1, 2018. CONTINUED AB 52 Page 5 Background Umbilical cord blood . Umbilical cord blood refers to the blood that remains in the umbilical cord and placenta following birth. It is one of three sources of cells used in transplants, along with bone marrow and peripheral blood stem cells. According to a July 2002 fact sheet by the March of Dimes, blood retrieved from the umbilical cord is a rich source of stem cells that can be used to treat various genetic disorders that affect the blood and immune system, leukemia and certain cancers, some inherited disorders of body chemistry, and other life-threatening diseases. Stem cells from umbilical cord blood offer some advantages over those retrieved from bone marrow. Umbilical cord blood stem cells are much easier to obtain; a broader range of recipients may benefit from them; and, a potentially fatal complication called graft versus host disease, in which donor cells can attack the recipient's tissues, appears to occur less frequently with umbilical cord blood than with bone marrow. Stem cells from umbilical cord blood have proven in many instances to be superior to traditional bone marrow transplants because they require a less perfect match than bone marrow transplants, thus making it more likely to find a suitable donor, especially among minority populations. The National Marrow Donor Program (NMDP) estimates that on any given day, more than 6,000 patients around the world are searching the NMDPs registry for a matching bone marrow or umbilical cord blood donor. The NMDP states that since umbilical cord blood is stored, ready to use and does not require a perfect donor match, it is especially useful for patients who need a transplant quickly, patients who have difficulty finding a matched bone marrow donor, and patients from racially diverse communities who often have uncommon tissue types. Patients are more likely to match someone who shares their racial and ethnic heritage. The NMDP reports that, in 2008, 36 percent of the 90,000 cord blood units in its registry went to patients from racially or ethnically diverse communities and the need for cord blood donations from these populations remain high. Umbilical cord blood banking for personal use . In January 2007, the American Academy of Pediatrics (AAP) issued an CONTINUED AB 52 Page 6 updated policy statement on umbilical cord blood banking for potential future transplantation. The AAP estimates that the chances of a child needing his or her own cord blood stem cells in the future range from 1 in 1,000 to 1 in 200,000. In the event that a child requires a stem cell transplant, the AAP indicates that it is unlikely that the child's own cord blood would be the desired source of stem cells, because the cells would reintroduce the disease into the child's body. In these cases, a sibling donor is ideal as a donor. AAP states that storing a child's cord blood is only worthwhile when there is a sibling with a disease who can be treated by a transplant. Under these circumstances, there is a one-in-four chance that the new baby will be a match for his or her sibling. Given that the probability of using one's own cord blood in the first 20 years of life is very small, the AAP does not favor storage of cord blood for personal use and instead encourages families to donate their newborn's cord blood to public banks, if accessible in their area, for use by other individuals in need. Umbilical cord blood banks (Banks) . Public and private Banks provide for the collection and storage of cord blood. Public banks promote both related and unrelated donation, similar to the current collection of whole blood units in the U.S., for transplantation or research purposes. Private Banks store umbilical cord blood from an individual for subsequent use by the same individual or his or her family members, should the need arise. Private Banks typically charge between $1,000 and $2,000 in collection fees and between $50 and $150 annually for storage. Public Banks do not charge for cord blood that is donated for public use. The American Association of Blood Banks (AABB) and the Foundation for the Accreditation of Cellular Therapy (FACT) provide voluntary accreditation of cord blood banks and establish standards governing all aspects of operation, including collection, processing, and transplantation. According to their respective Web sites, 27 facilities nationwide are currently accredited by the AABB and 17 currently have FACT accreditation. California banks and collection facilities . According to the NMDP, there are currently two participating public banks in California, StemCyte International Cord Blood CONTINUED AB 52 Page 7 Center in West Covina, which provides both public and private banking services, and Children's Hospital of Orange County Cord Blood Bank. Another public bank in San Diego, the Ashley Ross Cord Blood Program, participates in the NMDP, but it is not actively collecting cord blood at this time due to funding shortages. According to the nonprofit Parent's Guide to Cord Blood Foundation, there are additionally four private banks operating in the state: CordBancUSA in Monterey, Cord Blood America and FamilyCord, both based in Los Angeles, and Cord Blood Registry in San Bruno. The Laboratory Field Services Branch of DPH regulates umbilical cord blood banks in California. An umbilical cord blood bank that operates within California, accepts collections from California, or releases cord blood units to California, is required to obtain a biologics license from DPH, which must be renewed annually. DPH requires applicants to comply with specific requirements relating to personnel, relevant business permits, standard operating procedures, informed consent, laboratory testing, equipment, safety manuals and emergency plans, supplier and vendor information, quality control, and records. Generally, DPH requires facilities to be inspected prior to approving a license but will accept accreditation by AABB in lieu of an inspection in limited cases. According to the NMDP, because cord blood donation is only beginning to grow in prevalence, not all hospitals currently collect cord blood donations. The NMDP's registry is the largest listing of cord blood in the world (over 190,000 units), and includes banks outside of the U.S. In the U.S., NMDP has 14 cord blood banks with more than 46,000 cord blood units. In 2005, more than 250 cord blood units were provided for transplant, 29 percent of which went to racial and ethnic minorities. Forty percent of the cord blood units listed by NMDP are from minority racial and ethnic donors. Children's Hospital Oakland Research Institute operates a Sibling Donor Cord Blood Program for families who have a child with a transplant-treatable condition, and who are expecting a baby who is a full sibling of the affected child. UCLA operated a cord blood bank which originated CONTINUED AB 52 Page 8 with National Institutes of Health grants, but could not continue due to a lack of funding. The Ashley Ross Cord Blood Bank in San Diego has collected 2,300 cord blood units but is now releasing only one unit per month and is not accepting new donors as a result of lack of funding. One public and private bank in Florida, Cryobanks International, will accept and process donated cord blood units from anywhere in the United States. Marrow and umbilical cord blood matching . According to NMDP, marrow and cord blood transplants require matching certain tissue traits of the donor and patient. Because these traits are inherited, a patient's most likely match is someone of the same heritage. American Indian, Alaska Native, Asian, African-American, Latino, Native Hawaiian and other Pacific Islander, and multiple-race patients face a greater challenge in finding matched donors or cord blood than white patients. NMDP and other organizations, such as the National Cord Blood Program, are working to raise awareness and recruit more cord blood donors in underrepresented communities. In 2006, 26 percent of all recipients from minority racial and ethnic groups received cord blood transplants. Even with more than 50,000 cord blood units listed under NMDP, some patients were unable to find a match because of the rarity of their tissue traits. National Cord Blood Inventory . The National Cord Blood Inventory (NCBI), administered by the federal Health Resources and Services Administration (HRSA), was formed in 2006 to build a genetically and ethnically diverse inventory of 150,000 new units of high-quality umbilical cord blood for transplantation and to make these cord blood units available to physicians and patients for blood stem cell transplants, and for research focusing on cord blood stem cell biology. The NCBI works to achieve these goals by providing funds to eight participating cord blood banks nationwide. HRSA requested nearly $12 million in funding for the NCBI in 2009 to add approximately 8,650 new units of cord blood, and has collected a total of approximately 37,280 units collected to date. In November 2006, HRSA awarded $12 million to six institutions in California, Colorado, New York, North Carolina, Texas, and Washington to begin collections for CONTINUED AB 52 Page 9 the NCBI. According to HRSA, NCBI will collect and maintain high-quality cord blood units and make them available for transplantation through the newly created C.W. Bill Young Cell Transplantation Program. The NCBI target is 150,000 new units of high-quality cord blood collected from diverse populations, including those that have historically been the least able to find a suitable adult bone marrow donor match. The targeted demographics for the initial cord blood collections are: 19 percent African-American; 26 percent Latino; 6.5 percent Asian; 37.5 percent Caucasian; 10 percent multi-race; and, one percent other underrepresented populations. HRSA undertook a second cycle of competitive contracts to increase the NCBI early in federal fiscal year 2007. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: No SUPPORT : (Verified 9/14/10) American College of Obstetricians and Gynecologists, IX/CA (source) African American Blood Drive and Bone Marrow Registry for Sickle Cell Disease Awareness American Federation of State, County, and Municipal Employees Association of Northern California Oncologists Blood Centers of California California Catholic Conference California Communities United Institute California Hospital Association California Medical Association California Nurses Association California Nurse-Midwives Association California State University, Long Beach, Nursing Students City of Hope City of Los Angeles Commission on the Status of Women Joanne Pang Foundation Kaiser Permanente Medical Care Program March of Dimes Medical Oncology Association of Southern California Planned Parenthood Affiliates of California, Inc. Project RACE CONTINUED AB 52 Page 10 University of California OPPOSITION : (Verified 9/14/10) Child Abuse Prevention Center ARGUMENTS IN SUPPORT : UC states that by promoting public cord blood collection in one of the most ethnically diverse states in the nation, this bill expands the number of specific ethnic and multicultural cord blood units in the national inventory and increase the chance of a suitable match for Californians in need of a transplant. Writing on a previous version of the bill, the American College of Obstetricians and Gynecologists states that due to the high cost of testing and storing umbilical cord blood, it is reasonable to fund cord blood banking efforts with public dollars in order to increase the inventory of usable cord blood units. ARGUMENTS IN OPPOSITION : The Child Abuse Prevention Center (CAP Center) states that it opposes this bill unless amended to remove the increase in birth certificate fees as a funding source for the UCBCP. CAP Center states that birth certificate fees have long been a source of funding for child abuse prevention and intervention programs, and that adding to the fees for other purposes may make it less feasible to further raise them in the future for child abuse prevention. CAP argues that, given that fees for death certificates are lower than those for birth certificates, an increase in death certificate fees would be a more appropriate funding source for the bill. ASSEMBLY FLOOR : AYES: Adams, Ammiano, Anderson, Arambula, Beall, Tom Berryhill, Blakeslee, Blumenfield, Brownley, Buchanan, Caballero, Charles Calderon, Carter, Chesbro, Cook, Coto, Davis, De La Torre, De Leon, DeVore, Emmerson, Eng, Evans, Feuer, Fletcher, Fong, Fuentes, Furutani, Galgiani, Garrick, Gilmore, Hall, Harkey, Hayashi, Hernandez, Hill, Huber, Huffman, Jeffries, Jones, Krekorian, Lieu, Bonnie Lowenthal, Ma, Mendoza, Miller, Monning, Nava, Nestande, Nielsen, John A. Perez, V. Manuel Perez, Portantino, Price, Ruskin, Salas, Saldana, CONTINUED AB 52 Page 11 Skinner, Smyth, Solorio, Swanson, Torlakson, Torres, Torrico, Tran, Villines, Yamada, Bass NOES: Fuller, Gaines, Hagman, Knight, Logue, Niello, Silva, Audra Strickland NO VOTE RECORDED: Bill Berryhill, Block, Conway, Duvall CTW:do 9/14/10 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END **** CONTINUED