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---



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          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  




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          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  




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          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  




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          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  




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          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  




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          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  




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          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  




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          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:





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          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  




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          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 pregnant  may   shall  , 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 28

           SEC. 3   SEC 4  . 




                                    POSITIONS  




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          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
                                              






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