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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