BILL ANALYSIS SENATE JUDICIARY COMMITTEE Senator Ellen M. Corbett, Chair 2007-2008 Regular Session SB 962 S Senator Migden B As Amended April 19, 2007 Hearing Date: April 24, 2007 9 Health and Safety Code 6 ADM:rm 2 SUBJECT Umbilical Cord Blood Biomedical Resources Program DESCRIPTION This bill would require the State Department of Public Health (DPH) to establish the Umbilical Cord Blood Biomedical Resources Program for the purpose of collecting, processing, and storing umbilical cord blood stem cells to be used for transplantation and research. This bill would require DPH to establish fees to be collected from researchers and health care providers approved by the department to use umbilical cord blood for research or transplantation, and would create the Umbilical Cord Blood Biomedical Resources Program Fund into which the fees collected would be deposited. This bill would require DPH to develop standardized, objective information about umbilical cord blood donation that would enable a pregnant woman to be informed of her options to: (1) discard umbilical cord blood; (2) donate umbilical cord blood to a public bank; or (3) store the umbilical cord blood in a private bank. This bill would require a primary prenatal care provider, during a pregnant woman's first prenatal visit, to provide the cord blood banking information required by the bill's provisions to the woman. This bill would require DPH and health care providers to (more) SB 962 (Migden) Page 2 maintain the confidentiality of patient information, and would allow the use of patient information only for specified research purposes. This bill would provide that, for purposes of ensuring the security of a cord donor's personal information, before any umbilical cord blood could be released for research purposes, the California Health and Human Services Agency must determine if specified criteria and conditions have been met. BACKGROUND In December 2005, the federal government enacted H.R. 2520, the Stem Cell Therapeutic and Research Act of 2005, which establishes a national umbilical cord blood program and provides federal funding to expand and administer cord blood transplants and research. Among the many provisions in that measure is a requirement that the Secretary of Health and Human Services, through a public process, examine the issues of informed consent, including the appropriate timing of such consent, and the information provided a donor regarding medically appropriate cord blood donation options. The National Institute of Medicine (IOM) recommends that women be provided with balanced and clear information in order to actively and knowledgeably participate in the choice of whether or how to donate cord blood, with informed consent procedures. The IOM also recommends that appropriate measures should be taken to ensure the security, safety, and confidentiality of medical records, transplantable products, and patients. According to the Cord Blood Donor Foundation, "cord blood" (also known as "placental blood") is the blood that remains in the umbilical cord and placenta following birth and after the cord is cut. Newborn cord blood is recognized as a rich and powerful source of stem cells, which can be stored to retain their unique biological properties and before exposure to bacterial, viral, or other environmental factors. Stem cells recovered from umbilical cords can be used to treat as many as 70 blood diseases, including leukemia, myeloma and lymphoma; immunodeficiencies; and genetic diseases, including sickle cell anemia, thalassemia, inherited marrow failure disorders; and inherited disorders or errors of metabolisms. SB 962 (Migden) Page 3 Senate Bill 1555 (Speier, Chapter 484, Statutes of 2006), the Maternal and Child Health Advancement Act, provides, among other things, that, in order to provide umbilical cord blood banking storage services, a blood bank shall be licensed to do so under current blood bank licensing law. In addition, SB 1555, provides that a primary prenatal care provider of a pregnant woman may, during the first prenatal visit, provide a pregnant woman with information developed by the State Department of Health Services regarding her options with respect to cord blood banking at the same time the provider provides required information regarding the use and availability of prenatal screening for birth defects of the fetus. CHANGES TO EXISTING LAW 1. Existing law imposes various responsibilities on the State Department of Health Services (the department) and prenatal care providers with respect to prenatal care, screening, and counseling. [Health and Safety (H&S) Code Sections 120685-125107; 17 C.C.R. Sections 6404, 6500 et seq., and 6521 et seq.] Existing law , administered by the department, contains provisions governing the licensure of blood banks, including licensure or accreditation for purposes of umbilical cord blood banking. [H&S Sections 1602.5-1607.] This bill would require the State Department of Public Health (DPH) to establish the Umbilical Cord Blood Biomedical Resources Program for the purpose of collecting, processing, and storing umbilical cord blood stem cells to be used for transplantation and research. DPH would be required to establish: (1) a public repository for umbilical cord blood cells; (2) a system to retrieve and transport donations; and (3) a system for matching donors with recipients. This bill would require DPH to establish fees to be SB 962 (Migden) Page 4 collected from researchers and health care providers approved by the department to use umbilical cord blood for research or transplantation. The bill would create the Umbilical Cord Blood Biomedical Resources Program Fund in the State Treasury into which the fees collected would be deposited. 2. Existing law requires the department to conduct the Umbilical Cord Blood Community Awareness Campaign (UCBCAC), which, among other things, provides that a primary prenatal care provider, as defined, may provide to a pregnant woman during the first prenatal visit, certain information developed by the department regarding her options with respect to umbilical cord blood banking. [H&S Code Section 123370 et seq.] Existing law , the Hereditary Disorders Act, requires the department to establish regulations and standards for a hereditary disorders program, including with respect to prenatal testing programs for newborns. [H&S Section 124977.] Pursuant to this act, existing regulations require clinicians to provide all pregnant women, at the first prenatal visit, with information about the use and availability of prenatal screening for birth defects of the fetus. If a pregnant woman voluntarily requests prenatal screening, these regulations, among other things, require a clinician to make available to the pregnant woman the opportunity to read and sign a consent document, as specified. [17 C.C.R. Section 6527 (2007).] Effective July 1, 2007, responsibility for the above provisions will be transferred to the State Department of Public Health. This bill would, in addition, require a primary prenatal care provider, during the first prenatal visit of a woman who is known to be pregnant, to provide the cord blood banking information required by the bill's provisions to the woman. This bill would require the department, in addition to already required cord blood banking information development, to develop standardized, objective information about umbilical cord blood donation that would enable a pregnant woman to be informed of her SB 962 (Migden) Page 5 option to do any of the following: (1) discard umbilical cord blood; (2) donate umbilical cord blood to a public bank; or (3) store the umbilical cord blood in a private bank. This bill would, upon the development of the required cord blood banking information, require the department to include that information in the prenatal screening information materials currently established in regulation. 3. Existing law establishes the Umbilical Cord Blood Education Account, in which private donations are collected and deposited for the purpose of funding the information developed by the department pursuant to the UCBCAC, and requires these funds to be available upon a determination of the Director of Finance that sufficient private donations have been collected and deposited into the account, and provides that no public funds may be used. [H&S Code Section 123371.] This bill would allow both private and public funds to be used for purposes of the UCBCAC. 4. Existing law , the Information Practices Act, provides certain specified privacy and security protections for personal information held, used, or disseminated by a state agency. [Civil Code (CC) Sections 1798-1798.78.] Under existing law , the Committee for the Protection of Human Subjects (CPHS) serves as the institutional review board for the California Health and Human Services Agency for the purpose of assuring that research involving human subjects is conducted ethically and with minimum risk to participants. [See, e.g., CC Section 1798.24.] This bill would require DPH, health care providers, and local health departments to maintain the confidentiality of patient information in accordance with existing law and in the same manner as other medical record information with patient identification that they possess, and that the information shall only be used for the following research purposes: (1) to identify risk factors for children's and women's diseases; (2) to develop and evaluate screening tests; (3) to evaluate and SB 962 (Migden) Page 6 develop prevention strategies; and (4) to develop and evaluate treatments. This bill would provide that, for purposes of ensuring the security of a donor's personal information, before any umbilical cord blood could be released for research purposes, the CPHS must determine if specified criteria and conditions are met. [See Comment 6 for details.] COMMENT 1. Stated need for the bill The author writes: SB 962 [would] address two primary reasons why more cord blood transplants are not done today: (1) the lack of inventory and infrastructure in the state and nation; and (2) the lack of awareness and consequent opportunity on the part of pregnant women to exercise their personal choice regarding the distribution of their cord blood, now considered a valuable medical resource. Currently, 95% of cord blood is routinely discarded by California physicians, without a woman's knowledge or consent, so most physicians are already choosing one of the three cord blood options available to women, i.e., public donation, private donation, or discarding. Given increasing reports this year that cord blood may be being taken without a woman's consent, and that doctors are receiving financial compensation only to discuss private banking with patients, this bill is needed to ensure that women receive full information about their options and are able to exercise their personal wishes regarding the final destination of their cord blood. Patient documentation will provide future liability protection for doctors. DHS [Department of Health Services] has requested that the author update the current AFP [alpha-protein] screening [for some genetic abnormalities] regulation, which requires informed consent for prenatal screening, to also include a requirement for SB 962 (Migden) Page 7 information and consent for cord blood. DHS indicated to the author's office that they are already beginning to make revisions to the pamphlet to at least include a discussion of cord blood options. This prenatal informed consent booklet has been given to pregnant women for the last 20 years. 2. Related pending legislation Assembly Bill 34 (Portantino) would require DPH to establish, by July 1, 2009, the Umbilical Cord Blood Collection Program (the program) for the purpose of collecting and storing umbilical cord blood for public use. The bill would require DHP to contract with up to 5 blood banks that are licensed or accredited to provide umbilical cord blood banking storage services to collect, and make available to doctors and their patients, umbilical cord blood. The bill would establish a 15-member implementing committee, as specified, to provide guidance and policy suggestions to DPH on implementation of the program. The bill would allow DPH to accept both public and private funds to implement its provisions. The bill would require DPH, on or before January 1, 2012, to submit an interim report to the Assembly and Senate Health Committees on the effectiveness of the program in diversifying the umbilical cord blood supply, and would sunset the program December 31, 2018. This bill is currently in the Assembly Appropriations Committee. 3. Related federal legislation The Stem Cell Therapeutic and Research Act of 2005, enacted in December 2005, allows the Secretary of Health and Human Services to enter into one-time contracts with qualified cord blood banks to assist in the collection SB 962 (Migden) Page 8 and maintenance of 150,000 new units of high-quality cord blood to be made available for transplantation (through the C.W. Bill Young Cell Transplantation Program) and other specified purposes, including peer-reviewed research. [H.R. 2520, Public Law No. 109-129.] A contract recipient is required to, among other things, acquire, tissue-type, test, cryopreserve, and store donated units of cord blood acquired with donor informed consent, in compliance with federal and state regulations; encourage donation from a genetically diverse population; and ensure that collected cord blood units meet all applicable federal transplantation standards. The act requires the secretary to, through a public process, examine the following with respect to donor informed consent: (1) the appropriate timing of such consent; and (2) the information provided to the maternal donor regarding her medically appropriate cord blood options. To the best of committee staff's knowledge, the above public process and examination has not been completed. 4. SB 1555 (Speier, Chapter 484, Statutes of 2006); SB 962 would substantively alter SB 1555 Senate Bill 1555, the Maternal and Child Health Advancement Act, provides, among other things, that the State Department of Health Services is required 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 or not to participate in a private or public umbilical cord blood banking program. [H&S Section 123371.] Section 123371 outlines seven pieces of information to be included in the department's information: (1) current and potential future medical uses of stored umbilical cord blood; (2) 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 may impact a family's consideration of umbilical cord blood banking; (5) an explanation of the differences between public and private umbilical cord blood banking; (6) availability and costs of public or SB 962 (Migden) Page 9 private umbilical cord blood banks; and (7) 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. Section 123371 also provides that the primary prenatal care provider of a pregnant woman may, during the first prenatal visit, provide the woman with information developed by the department regarding her options with respect to cord blood banking at the same time the provider provides required information regarding the use and availability of prenatal screening for birth defects of the fetus. Senate Bill 962 would require the primary prenatal care provider of a pregnant woman, during the first prenatal visit, to provide information developed by the department regarding her options with respect to cord blood banking. Senate Bill 962 would thus substantively alter the provisions of SB 1555. The author and sponsor report that the implementing regulations called for in SB 1555, with the required standardized, objective umbilical cord blood banking information, have not been adopted or promulgated. In addition, neither the specificity of what cord blood banking information nor the appropriate timing of when such information should be provided to a pregnant woman have been determined at the state or federal level. 5. Privacy and confidentiality concerns raised by the bill; suggested amendments Because this bill would allow for the collection, processing, and storage of umbilical cord blood stem cells for transplantation and research, a donor's personal and confidential information and privacy interests should be protected to the greatest extent possible. And, while the Information Practices Act provides some privacy and confidentially protections, SB 962 (Migden) Page 10 committee staff suggests that further protections be added to the bill. Suggested amendments: On page 6, after line 15, add the following: All information collected pursuant to the Umbilical Cord Blood Biomedical Resources Program shall be confidential and shall be used solely for the purposes of the program. Access to confidential information shall be limited to authorized persons who agree in writing to maintain confidentiality. The department shall maintain an accurate record of all persons who are given confidential information. Any disclosure of confidential information shall be made only upon written agreement that the information will be kept confidential, used for the approved purpose, and not be further disclosed. Any person who, in violation of a written agreement to maintain confidentiality, discloses any information provided pursuant to this section, or who uses information pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to any confidential information maintained by the department. That person shall also be subject to a civil penalty of $1,000. The penalty provided in this section shall not be construed as restricting any remedy, provisional or otherwise, provided by law for the benefit of the department or any person. Notwithstanding the restrictions of this section, an individual to whom the information pertains shall have access to his or her own information. 6. Research security provisions provided in the bill This bill would require the following for purposes of security of a donor's personal information for research: (1) a plan sufficient to protect personal information from improper use and disclosures, including sufficient SB 962 (Migden) Page 11 administrative, physical, and technical safeguards; (2) a sufficient plan to destroy or return all personal information as soon as it is no longer needed for the research activity; and (3) sufficient written assurances that the personal information will not be reused or disclosed to other persons or entities, except as specified. 7. Opponents California Medical Assoc. (CMA) and American College of Obstetricians and Gynecologists (ACOG) arguments CMA and ACOG oppose the bill for a number of reasons. Both opponents argue that SB 962 reverses work done on SB 1555. "SB 962 puts physicians in an untenable 'Catch-22' situation requiring them to hand out informational brochures that the state is only required to provide and keep current if there is funding to do so. This could require doctors to give out outdated, medically inaccurate brochures or risk violating the law. SB 1555 solved this problem by making this provision voluntary on the part of the doctor." Opponent ACOG argues that the bill would interfere with and diminish "the physician-patient relationship by requiring mandated, possibly out-of-date and medically inappropriate material for the physician-patient discussion. ACOG Perinatal Guidelines state a discussion should occur, but that discussion will vary depending on that particular woman's genetic background and situation." ACOG also argues that even when a statute, such as this one, requires the state-mandated materials to be kept up-to-date, in practice that does not occur. For example, the breast cancer brochure is required to be updated every three years, but it has yet to be updated since its initial 1995 version. This "puts physicians in a legally tenuous position when they are mandated to distribute medically inaccurate information to their patients, potentially opening them up to allegations of negligence. At a minimum, it creates confusion and a potential situation for suspicion of the physician when the physician's statements and the materials conflict. This scenario is why SB 1555 was changed to having the SB 962 (Migden) Page 12 distribution of materials be voluntary." Opponent CMA also states it is "troubled by the link this bill makes between umbilical cord blood banking and prenatal genetic screening. Requiring these conversations to occur concurrently may send the wrong message to expectant parents and could pressure them to privately bank their baby's cord blood, which is usually unnecessary and can be very costly. The universal solicitation this bill [would mandate] is inappropriate and unnecessary since it is already the ACOG standard of care for a discussion to occur between physician and patient about umbilical cord blood banking options." Support: Asian American Donor Program; CA Catholic Conference; Cord Blood Donor Foundation Opposition: CA Medical Assoc.; American College of Obstetricians and Gynecologists, District IX/CA HISTORY Source: Author; American Association of University Women; Planned Parenthood Affiliates of CA Related Pending Legislation: AB 34 (Portantino of 2007) (See Comment 2.) Prior Legislation: SB 1555 (Speier, Chapter 484, Statutes of 2006). (See Comment 4.) Prior Vote: Senate Health Committee (Ayes 6, Noes 3) **************