BILL ANALYSIS SENATE HEALTH COMMITTEE ANALYSIS Senator Sheila J. Kuehl, Chair BILL NO: SB 962 S AUTHOR: Migden B AMENDED: April 12, 2007 HEARING DATE: April 18, 2007 9 REFERRAL: Health and Judiciary 6 FISCAL: Appropriations 2 CONSULTANT: Tadeo/cjt SUBJECT Umbilical cord blood banking SUMMARY Requires the Department of Public Health (DPH) to establish a state umbilical cord blood banking program that provides for the collection, processing and storage of umbilical cord blood stem cells to be used for transplant and research purposes. Requires clinicians to provide information about the program and umbilical cord blood banking in conjunction with information they currently provide regarding the use and availability of prenatal screening for birth defects. Allows DPH to charge approved investigators and health care providers costs related to use of cord blood for research or transplantation purposes. CHANGES TO EXISTING LAW Existing federal law: Continued--- STAFF ANALYSIS OF SENATE BILL 962 (Migden) Page 2 Federal law establishes a national umbilical cord blood network and authorizes funding to collect and maintain human cord blood stem cells for the treatment of patients and for research. Federal law also includes a process for maternal donors to be informed of all medically appropriate options for core blood banking. Existing federal law includes additional directives for cord blood donation, education and advocacy. Existing state law: Under current law, blood banks must be licensed in order to provide umbilical cord blood banking storage services, and DHS is permitted to implement standards under which blood banks to store umbilical cord blood through the adoption of regulations. Current law also requires DHS, contingent upon private funding, to conduct the Umbilical Blood Community Awareness Campaign to provide awareness, assistance and information regarding umbilical cord blood banking options using print media, radio, the Internet, outdoor advertising and other media, to establish an Internet Web site, and to undertake public education activities. Additionally, current law requires DHS to develop standardized, objective information about umbilical cord blood donation that is sufficient to allow a pregnant woman to make an informed decision on whether to participate in a private or public umbilical cord banking program. Responsibility for administering these provisions will be transferred to the DPH effective July 1, 2007. Under existing law, prenatal physicians are required to consult with pregnant women and give them standardized information about options for prenatal screening for birth defects of the fetus, during the first prenatal visit. Current law also provides that a prenatal care provider may provide a pregnant woman with information regarding her options with respect to umbilical cord blood banking at that time. This bill: This bill would require DPH to establish a state umbilical cord blood collection program for the purpose of collecting, processing and storing umbilical cord blood stem cells to be used for transplant and research purposes. This bill would require DPH to establish a repository for umbilical cord blood stem cells to ensure cord blood is STAFF ANALYSIS OF SENATE BILL 962 (Migden) Page 3 collected, stored and distributed according to patient wishes, establish a system to retrieve and transport umbilical blood donations, and establish a system for matching umbilical cord donors with recipients of umbilical cord blood for medicinal use. This bill would also require DPH to update the information given to pregnant women concerning prenatal testing for genetic disorders with information about this program, which would include the options of discarding the stem cells, donating the stem cells to a public umbilical cord bank and storing the stem cells in a family umbilical cord bank for use by immediate and extended family members. This bill would require DPH to establish fees, not to exceed the costs of program administration, to be collected from approved researchers and health providers who seek the umbilical cord blood for research or transplantation. This bill would create the Umbilical Cord Blood Collection Program Fund in the State Treasury for the deposit of these fees. FISCAL IMPACT Unknown. BACKGROUND AND DISCUSSION Purpose of the Bill According to the author, the intent of this bill is to create a state infrastructure to increase cord blood donations. The Institute of Medicine (IOM) estimates that umbilical cord blood could help treat 11,700 Americans a year with leukemia and other devastating diseases, yet is routinely discarded by the medical community. The author states that this bill is designed to inform expectant families about the potential uses of umbilical cord blood, within DPH's existing prenatal screening program, and offer standardized, objective information to all maternity patients about public and private cord blood banking. The author also states that that this bill would address inequity in current law which requires full donor STAFF ANALYSIS OF SENATE BILL 962 (Migden) Page 4 education information to be given to address shortages of organs and tissues for only certain medical diseases and situations. Currently, the law requires donor education aimed at increasing organ and tissue donations, but is silent on cord blood donation, which is now considered the most viable medical treatment alternative for many diseases for which people are on waiting lists. The author further argues that umbilical cord blood is a non-controversial source of stem cell research. Umbilical Cord Blood Cord blood is the blood that remains in the umbilical cord and placenta following birth. 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. Like bone marrow, cord blood can be used to treat various genetic disorders that affect the blood and immune system, leukemia and certain cancers, and some inherited disorders of body chemistry. Stem cells from cord blood offer some advantages over those retrieved from bone marrow. 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 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. California Banks and Collection Facilities According to the National Marrow Donor Program (NMDP), because cord blood donation is only beginning to grow in prevalence, not all hospitals currently collect cord 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 diverse STAFF ANALYSIS OF SENATE BILL 962 (Migden) Page 5 racial and ethnic donors. StemCyte International Cord Blood Center in West Covina and Children's Hospital of Orange County Cord Blood Bank are the only NMDP participating public banks in California. 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 with NIH grants, but could not continue due to a lack of funding. Another public bank in San Diego, the Ashley Ross Cord Blood Bank, 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. (Private cord blood banking costs about $1,300 initially and $150 annually after the first year.) Private Banks and Referrals The Sacramento Bee recently investigated problems in the private cord blood banking field, including aggressive marketing to expectant parents, and payments to doctors for referrals. The investigation found that, in some cases, marketing included emotional statements and testimonials to encourage parents to provide their unborn child with future health advantages through cord blood banking, in order to treat illnesses that might occur in the future. It was also reported in the investigation that there are few indications for the use of a child's own banked umbilical cord, such as a congenital problem or a genetic history of certain cancers; and that many medical providers believe the procedure is unnecessary. The investigation further revealed that doctors have been paid to attend dinners funded by cord blood companies and offered $250 for each blood banking referral, as well as free cord banking services for their children. Related state legislation SB 164 (Migden) changes the name of the Birth Defects Monitoring Program to the Birth Defects Monitoring and Biomedical Research Program, directs the DPH to charge STAFF ANALYSIS OF SENATE BILL 962 (Migden) Page 6 investigators approved by the department a fee for access to the program for research, creates the Birth Defects Monitoring and Biomedical Research Fund and requires the program to develop protocols for actions related to blood specimens, as determined by the program. This bill is currently in Senate Appropriations Committee AB 34 (Portantino) creates the Umbilical Cord Blood Collection Program in DPH, for the purpose of collecting and storing umbilical cord blood for public use, permits DPH to contract with up to five blood banks licensed to provide umbilical cord blood banking storage services to build an inventory of umbilical cord blood units and make this blood available to doctors and their patients. Establishes an advisory committee. This bill is currently in Assembly Appropriations Committee Prior federal legislation H.R. 2520 (Smith, 2005) establishes a national umbilical cord blood program and provides federal funding to expand and administer core blood transplants and research. Prior State Legislation SB 253 (Ortiz, Chapter 789, Statutes of 2002) permits all forms of stem cell research in the State of California, and requires certain health care providers to provide patients with information relating to the disposition of any human embryos remaining following fertility treatment. SB 617 (Speier, Chapter 464, Statutes of 2003) requires tissue banks to inform donor families of all uses of donated tissues, including for-profit uses. SB 1555 (Speier, Chapter 484, Statutes of 2006) requires blood banks to be licensed to provide umbilical cord blood banking storage services, and requires DHS, contingent upon private funding, to conduct the Umbilical Blood Community Awareness Campaign. According to DHS, no funding has been received to implement the campaign. Arguments in Support Supporters state that hundreds of children with sickle cell STAFF ANALYSIS OF SENATE BILL 962 (Migden) Page 7 anemia have been cured through the transplantation of stem cells taken from cord blood and that many more children with sickle cell anemia and other blood diseases could be helped. Supporters add that many other people with chronic or possibly life-threatening diseases may be aided. The Cord Blood Donor Foundation states that stem cells recovered from umbilical cords are used to treat more than 60 diseases, including leukemia, sickle cell anemia, and lymphoma, and eventually, the use of cord blood stem cells is expected to replace painful bone marrow transplants for the treatment of many diseases. Arguments in Opposition The American College of Obstetricians and Gynecologists state that their current standard of care already includes a discussion between a physician and a patient about umbilical cord blood banking options, and while people with certain genetic family histories, such as sickle cell anemia, should be encouraged to bank cord blood, no major professional medical organization encourages private banking for "biological insurance." They further argue that while public banking should be encouraged, there is a limited infrastructure and ability to accept blood at this time, and with a genetically diverse inventory, only 250,000 units are needed nationwide to serve the entire population. Additionally, federal legislation has already appropriated $80 million to improve umbilical cord blood inventory and programs in California focusing on hospitals with high numbers of deliveries and certain racial and ethnic populations. Additionally, they argue that this bill is unnecessary given that SB 1555 last year created an umbilical cord blood public awareness program at DHS. Opponents also argue that in order for materials to be given to patients they must be medically accurate, culturally sensitive, linguistically appropriate and when required by the state, have a compelling need, and that physicians are in a difficult position when they are mandated to distribute medically inaccurate information to their patients. COMMENTS AND QUESTIONS 1. Need for a state-administered umbilical cord bank is STAFF ANALYSIS OF SENATE BILL 962 (Migden) Page 8 unclear. Several public cord blood banks exist, including two NMDP banks in California. In addition, as a result of passage of HR 2520 in 2005, additional public banks will be in operation and will be focusing on collecting core blood to address gaps in the availability of cord blood. The author should be asked why she believes a state cord blood bank is necessary at this time. 2. The scope of women to receive information is too narrow. The bill requires information about cord blood to be provided to women who have been screened and determined to be potential candidates for genetic testing. While this population may potentially benefit from private banking of cord blood, a broader approach is necessary to boost donation to public banks which serve the entire population. A suggested amendment would be to de-link the bill from the current screening and informed consent process for genetic prenatal testing, and, as reflected in the mock-up below, instead require providers to provide standard information about cord blood banking, developed by DPH, to all pregnant women at the first prenatal care visit. SB 1555 already requires DPH to develop this information and states that prenatal care providers, may, as opposed to shall, provide the information to pregnant women. Existing law provides that DHS must develop and provide the information using only private funds, which to date have not been received. Suggested amendments reflected in the mock-up below would remove the private funding requirement and provide that prenatal care providers shall provide this information. 3. Additional information about banking of cord blood would be useful to expectant families. The standard information that the bill would require to be provided to pregnant women is more limited than that contained in SB 1555, which the committee heard last session, and which was signed into law, but which has been delayed pending receipt of private funding. As a result, as drafted, the bill would not ensure that pregnant women receive complete information, including the current potential uses of cord blood; the benefits, risks and costs of donating cord blood or banking cord blood for personal medical use; medical and family history criteria that should be taken into account in considering private or public banking; and an explanation that the practices and policies of blood banks STAFF ANALYSIS OF SENATE BILL 962 (Migden) Page 9 vary. A suggested amendment would be to incorporate the options concerning the use of cord blood that this bill would require be provided to women with the information that is already included in SB1555. The proposed mock-up below includes these suggested changes. 4. Requiring doctors to provide information on umbilical cord banking and options can be burdensome and inconsistent. Current standards of care include a discussion between a physician and a patient about umbilical cord options. As such, the information itself and the degree to which it is given may not be consistent. Requiring the DPH to develop and update the information for providers, and requiring that providers give this information to pregnant patients will ensure that the information is reaching the public in a uniform way. Furthermore, making the information available to clinicians eases the burden for them to have to develop and collect it themselves. The proposed mock-up below includes these suggested changes. Suggested amendments: Page 3 lines 29 - 39(4) Update the information provided to pregnant women pursuant to Section 6527 of Title 17 of the California Code of Regulations with information about this program. The requirements associated with this section shall also include the option of umbilical cord blood banking. For purposes of this section, these options shall include all of the following: (A) Discarding the stem cells. (B) Donating the stem cells to a public umbilical cord blood bank. (C) Storing the stem cells in a family umbilical cord blood bank for the use by immediate and extended family members.Page 4, beginning at line 28, insert: STAFF ANALYSIS OF SENATE BILL 962 (Migden) Page 10 SEC. 3 Section 123371 of the Health and Safety Code is amended to read: 123371. (a) The State Department of Health Services shall develop standardized, objective information about umbilical cord blood donation that is sufficient to allow a pregnant woman to make an informed decision on whether to participate in a private or public umbilical cord blood banking program. The options shall include all of the following: (A) Discarding the umbilical cord blood. (B) Donating the umbilical cord blood to a public umbilical cord blood bank. (C) Storing the umbilical cord blood in a family umbilical cord blood bank for the use by immediate and extended family members. This information shall include, but not be limited to, all of the following: (1) The current and potential future medical uses of stored umbilical cord blood. (2) The benefits and risks involved in umbilical cord blood banking. (3) The medical process involved in umbilical cord blood banking. (4) Medical or family history criteria that can impact a family's consideration of umbilical cord banking. (5) An explanation of the differences between public and private umbilical cord blood banking. (6) The availability and costs of public or private umbilical cord blood banks. (7) Medical or family history criteria that can impact a family's consideration of umbilical cord blood banking. (8) An explanation that the practices and policies of blood banks may vary with respect to accreditation, cord blood processing and storage methods, costs, and donor privacy. (b) The information provided by the department pursuant to subdivision (a) shall be made available in Cantonese, English, Spanish, and Vietnamese. (b) shall be updated by the STAFF ANALYSIS OF SENATE BILL 962 (Migden) Page 11 department as needed. (c) The information provided by the department pursuant to subdivision (a) shall be made available on the Internet Web sites of the licensing boards that have oversight over primary prenatal care providers. (d) (1) The primary prenatal care provider of a woman who is known to be pregnantmayshall , during the first prenatal visit, provide her with information developed by the department regarding her options with respect to umbilical cord blood banking , once this information is made available at the same time the provider provides information regarding the use and availability of prenatal screening for birth defects of the fetus, as required by Section 6527 of Title 17 of the California Code of Regulations. (2) For purposes of this article, a "prenatal care provider" means a health care provider licensed pursuant to Division 2 (commencing with Section 500) of the Business and Professions Code, or pursuant to an initiative act referred to in that division, who provides prenatal medical care within his or her scope of practice.(e) The department shall only implement this article upon a determination by the Director of Finance, that sufficient private donations have been collected and deposited into the Umbilical Cord Blood Education Account, which is hereby created in the State Treasury. The moneys in the account shall be available, upon appropriation by the Legislature, for the purposes of this article. No public funds shall be used to implement this article. If sufficient funds are collected and deposited into the account, the Director of Finance shall file a written notice thereof with the Secretary of State.Page 4, line 28SEC. 3SEC 4 . POSITIONS STAFF ANALYSIS OF SENATE BILL 962 (Migden) Page 12 Support: American Association of University Women (received late) California Catholic Conference Cord Blood Donor Foundation One individual Oppose: American College of Obstetricians and Gynecologists California Medical Association -- END --