BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: AB 52
A
AUTHOR: Portantino
B
AMENDED: August 9, 2010
HEARING DATE: August 11, 2010
5
CONSULTANT:
2
Tadeo/Hansel/cjt
FOR VOTE ONLY
SUBJECT
Umbilical Cord Blood Collection Program
SUMMARY
Requests the University of California (UC) to develop a
plan to establish and administer the Umbilical Cord Blood
Collection Program (UCBCP) for the purpose of collecting
units of umbilical cord blood for public use, as specified.
Increases the fee for birth certificate copies by $2 to
provide funds to implement the UCBCP. Requires UC to
implement the plan, contingent on an unspecified amount of
funds being available in the UCBCP Fund (Fund).
CHANGES TO EXISTING LAW
Existing federal law:
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. Existing federal law also includes
directives for umbilical cord blood donation, education and
advocacy.
Existing state law:
Requires the Department of Public Health (DPH), until
January 1, 2015, to establish the UCBCP for the purpose of
Continued---
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increasing the amount of umbilical cord blood that is
donated in the state and added to the national umbilical
cord blood inventory.
Authorizes the UCBCP, to the extent private or public funds
are identified and secured for these purposes, to identify
and provide funds for grants or contracts with qualified
blood banks that are licensed and accredited to collect and
store umbilical cord blood for public transplantation
purposes. Permits DPH to implement any additional
standards for blood banks, to collect and store umbilical
cord blood, through the adoption of regulations.
Establishes the Umbilical Cord Blood Collection Program
Fund (Fund), consisting of federal, state, and private
funds made available for purposes of the program
Requires DPH, contingent upon private funding, to conduct
the Umbilical Cord Blood Community Awareness Campaign to
provide awareness, assistance, and information regarding
umbilical cord blood banking options using brochures,
television, print media, radio, the Internet, outdoor
advertising, and other media; establish an Internet Web
site with specified information; and, undertake public
education activities related to umbilical cord blood
donation to targeted populations, as appropriate.
Requires DPH to provide umbilical cord blood samples to the
Birth Defect Monitoring Program, for storage and research,
as specified.
This bill:
Requests UC, by July 1, 2011, to develop a plan to
establish and administer the UCBCP for the purpose of
collecting units of umbilical cord blood for public use as
specified, and deletes DPH's responsibility for
administering the program. Expresses intent that UC submit
the plan to the health and fiscal committees of the
Legislature.
Adds $2 to the current fee for certified copies of birth
certificates and requires the additional $2 to be paid into
the Fund for support of the UCBCP.
Expresses intent that UC implement the UCBCP when the
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Controller determines, not later than an unspecified date,
that at least an unspecified amount of money is available
in the Fund. Provides that funds shall be appropriated for
the UCBCP to the extent the plan and implementation of the
program are consistent with the goals and intent of the
bill. Also provides that moneys appropriated for the UCBCP
shall be available for encumbrance or expenditure for three
fiscal years following the appropriation of the funds.
Provides that nothing shall preclude UC from establishing
and administering an additional fund for support of the
UCBCP, or for associated clinical research activities.
Defines public use of umbilical cord blood as blood units
from genetically diverse donors that will be owned by the
UC. Requires the inventory to be accessible by the
National Registry and other qualified registries and
transplant centers, as specified, for transplantation and
research uses.
Permits UC, for the purpose of implementing cord blood
collection goals of the program, to contract with one or
more entities that are in compliance with federal
guidelines and regulations.
Permits UC to use a competitive process to select entities
to administer the collection and research objectives of the
program, if the UC chooses not to undertake these
activities itself. Requires entities selected to receive,
process, and preserve, or bank cord blood units to have, at
minimum, an investigational new drug exemption or a
biological license from the Federal Drug Administration.
Establishes qualifications for an entity to receive
umbilical cord blood units for research, and requires a
medical provider or research facility to comply with all
applicable state and federal laws with respect to
personally identifiable information contained in the
inventory. Subjects these entities to existing penalties
for violations.
Expresses the intent of the Legislature that UC limit fees
for access to cord blood units to the reasonable and actual
costs of storage, handling, and providing units, as well as
for related services, as specified.
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Additionally expresses the intent of the Legislature that
UC:
Develop a strategy to increase voluntary participation by
hospitals in the collection and storage of umbilical cord
blood and identify funding sources to offset the
financial impact on hospitals;
Consider a medical contingency response program to
prepare for and respond effectively to biological,
chemical, or radiological attacks, accidents, and other
public health emergencies where victims potentially
benefit from treatment; and,
Explore the feasibility of operating the program as a
self-funding program, including the potential of charging
users a reimbursement fee.
Permits UC to deny further access to any confidential
information maintained by the UC to any person who violates
its policies to maintain confidentiality of information,
and subjects them to a civil penalty of up to $1,000.
Sunsets the UCBCP and the $2 additional birth certificate
fee on January 1, 2018.
FISCAL IMPACT
According to the Assembly Appropriations Committee analysis
of AB 52, this bill would result in increased annual
special fund revenues of $3 million as a result of the $2
increased fee on 1.5 million certified birth certificates.
The analysis notes that revenues will change with changes
in California's birth rate or demand for the vital records
documents. The analysis also estimated that DPH would
incur staffing costs of $550,000 to $650,000 for contract
management, research and policy collaboration, and
technical assistance. The current version of the bill
shifts responsibility for administering the UCBCP from DPH
to UC.
BACKGROUND AND DISCUSSION
The author states that the National Cord Blood Inventory
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(NCBI) currently lacks ethnic and multiracial cord blood
and the UCBCP is intended to collect cord blood for public
use and to increase the volume of cord blood that can be
added to the national inventory. According to the author,
this bill prescribes important requirements relating to
donor confidentiality protections, minimum program
standards, reporting requirements, and a temporary funding
mechanism, that are needed to fully implement the UCBCP.
The author states that this bill will ensure collections
from California's ethnically diverse communities and will
help to address shortages in cord blood donations from
minority groups, increasing the likelihood of transplant
patients finding suitable donor matches.
The author further states that DPH, with more than 300
varied health programs, is facing major budget cuts and
significant reorganization and has not been willing to
provide support for the funding or administration strategy
of the program. Many relationships already exist between
the University and birthing hospitals throughout the state,
and UC has cord blood experts within its system and
operated an umbilical cord blood bank at UCLA in the late
1990s.
Umbilical cord blood
Umbilical cord blood refers to the blood that remains in
the umbilical cord and placenta following birth. It is one
of three sources of cells used in transplants, along with
bone marrow and peripheral blood stem cells. According to
a July 2002 fact sheet by the March of Dimes, blood
retrieved from the umbilical cord is a rich source of stem
cells that can be used to treat various genetic disorders
that affect the blood and immune system, leukemia and
certain cancers, some inherited disorders of body
chemistry, and other life-threatening diseases. Stem cells
from umbilical cord blood offer some advantages over those
retrieved from bone marrow. Umbilical cord blood stem
cells are much easier to obtain; a broader range of
recipients may benefit from them; and, a potentially fatal
complication called graft versus host disease, in which
donor cells can attack the recipient's tissues, appears to
occur less frequently with umbilical cord blood than with
bone marrow. Stem cells from umbilical cord blood have
proven in many instances to be superior to traditional bone
marrow transplants because they require a less perfect
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match than bone marrow transplants, thus making it more
likely to find a suitable donor, especially among minority
populations.
The National Marrow Donor Program (NMDP) estimates that on
any given day, more than 6,000 patients around the world
are searching the NMDPs registry for a matching bone marrow
or umbilical cord blood donor. The NMDP states that since
umbilical cord blood is stored, ready to use and does not
require a perfect donor match, it is especially useful for
patients who need a transplant quickly, patients who have
difficulty finding a matched bone marrow donor, and
patients from racially diverse communities who often have
uncommon tissue types. Patients are more likely to match
someone who shares their racial and ethnic heritage. The
NMDP reports that, in 2008, 36 percent of the 90,000 cord
blood units in its registry went to patients from racially
or ethnically diverse communities, and the need for cord
blood donations from these populations remains high.
Umbilical cord blood banking for personal use
In January 2007, the American Academy of Pediatrics (AAP)
issued an updated policy statement on umbilical cord blood
banking for potential future transplantation. The AAP
estimates that the chances of a child needing his or her
own cord blood stem cells in the future range from 1 in
1,000 to 1 in 200,000. In the event that a child requires
a stem cell transplant, the AAP indicates that it is
unlikely that the child's own cord blood would be the
desired source of stem cells, because the cells would
reintroduce the disease into the child's body. In these
cases, a sibling donor is ideal as a donor. AAP states
that storing a child's cord blood is only worthwhile when
there is a sibling with a disease who can be treated by a
transplant. Under these circumstances, there is a
one-in-four chance that the new baby will be a match for
his or her sibling. Given that the probability of using
one's own cord blood in the first 20 years of life is very
small, the AAP does not favor storage of cord blood for
personal use and instead encourages families to donate
their newborn's cord blood to public banks, if accessible
in their area, for use by other individuals in need.
Umbilical cord blood banks
Public and private banks provide for the collection and
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storage of cord blood. Public banks promote both related
and unrelated donation, similar to the current collection
of whole blood units in the U.S., for transplantation or
research purposes. Private banks store umbilical cord
blood from an individual for subsequent use by the same
individual or his or her family members, should the need
arise. Private banks typically charge between $1,000 and
$2,000 in collection fees and between $50 and $150 annually
for storage. Public banks do not charge for cord blood
that is donated for public use. The American Association
of Blood Banks (AABB) and the Foundation for the
Accreditation of Cellular Therapy (FACT) provide voluntary
accreditation of cord blood banks and establish standards
governing all aspects of operation, including collection,
processing, and transplantation. According to their
respective Web sites, 27 facilities nationwide are
currently accredited by the AABB and 17 currently have FACT
accreditation.
California banks and collection facilities
According to the NMDP, there are currently two
participating public banks in California, StemCyte
International Cord Blood Center in West Covina, which
provides both public and private banking services, and
Children's Hospital of Orange County Cord Blood Bank.
Another public bank in San Diego, the Ashley Ross Cord
Blood Program, participates in the NMDP, but it is not
actively collecting cord blood at this time due to funding
shortages. According to the nonprofit Parent's Guide to
Cord Blood Foundation, there are additionally four private
banks operating in the state: CordBancUSA in Monterey, Cord
Blood America and FamilyCord, both based in Los Angeles,
and Cord Blood Registry in San Bruno.
The Laboratory Field Services Branch of DPH regulates
umbilical cord blood banks in California. An umbilical
cord blood bank that operates within California, accepts
collections from California, or releases cord blood units
to California, is required to obtain a biologics license
from DPH, which must be renewed annually. DPH requires
applicants to comply with specific requirements relating to
personnel, relevant business permits, standard operating
procedures, informed consent, laboratory testing,
equipment, safety manuals and emergency plans, supplier and
vendor information, quality control, and records.
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Generally, DPH requires facilities to be inspected prior to
approving a license but will accept accreditation by AABB
in lieu of an inspection in limited cases.
According to the NMDP, because cord blood donation is only
beginning to grow in prevalence, not all hospitals
currently collect cord blood donations. The NMDP's
registry is the largest listing of cord blood in the world
(over 190,000 units), and includes banks outside of the
U.S. In the U.S., NMDP has 14 cord blood banks with more
than 46,000 cord blood units. In 2005, more than 250 cord
blood units were provided for transplant, 29 percent of
which went to racial and ethnic minorities. Forty percent
of the cord blood units listed by NMDP are from minority
racial and ethnic donors.
Children's Hospital Oakland Research Institute operates a
Sibling Donor Cord Blood Program for families who have a
child with a transplant-treatable condition, and who are
expecting a baby who is a full sibling of the affected
child. UCLA operated a cord blood bank which originated
with National Institutes of Health grants, but could not
continue due to a lack of funding. The Ashley Ross Cord
Blood Bank in San Diego has collected 2,300 cord blood
units but is now releasing only one unit per month and is
not accepting new donors as a result of lack of funding.
One public and private bank in Florida, Cryobanks
International, will accept and process donated cord blood
units from anywhere in the United States.
Marrow and umbilical cord blood matching
According to NMDP, marrow and cord blood transplants
require matching certain tissue traits of the donor and
patient. Because these traits are inherited, a patient's
most likely match is someone of the same heritage.
American Indian, Alaska Native, Asian, African-American,
Latino, Native Hawaiian and other Pacific Islander, and
multiple-race patients face a greater challenge in finding
matched donors or cord blood than white patients. NMDP and
other organizations, such as the National Cord Blood
Program, are working to raise awareness and recruit more
cord blood donors in underrepresented communities. In
2006, 26 percent of all recipients from minority racial and
ethnic groups received cord blood transplants. Even with
more than 50,000 cord blood units listed under NMDP, some
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patients were unable to find a match because of the rarity
of their tissue traits.
National Cord Blood Inventory
The National Cord Blood Inventory (NCBI), administered by
the federal Health Resources and Services Administration
(HRSA), was formed in 2006 to build a genetically and
ethnically diverse inventory of 150,000 new units of
high-quality umbilical cord blood for transplantation and
to make these cord blood units available to physicians and
patients for blood stem cell transplants, and for research
focusing on cord blood stem cell biology. The NCBI works
to achieve these goals by providing funds to eight
participating cord blood banks nationwide. HRSA requested
nearly $12 million in funding for the NCBI in 2009 to add
approximately 8,650 new units of cord blood, and has
collected a total of approximately 37,280 units collected
to date.
In November 2006, HRSA awarded $12 million to six
institutions in California, Colorado, New York, North
Carolina, Texas, and Washington to begin collections for
the NCBI. According to HRSA, NCBI will collect and
maintain high-quality cord blood units and make them
available for transplantation through the newly created
C.W. Bill Young Cell Transplantation Program. The NCBI
target is 150,000 new units of high-quality cord blood
collected from diverse populations, including those that
have historically been the least able to find a suitable
adult bone marrow donor match. The targeted demographics
for the initial cord blood collections are: 19 percent
African-American; 26 percent Latino; 6.5 percent Asian;
37.5 percent Caucasian; 10 percent multi-race; and, 1
percent other underrepresented populations. HRSA undertook
a second cycle of competitive contracts to increase the
NCBI early in federal fiscal year 2007.
Federal regulatory action
The FDA regulates cord blood under the category of human
cells, tissues, and cellular and tissue-based products. In
2005, the FDA issued final rules requiring all public and
private cord banks to register with the FDA and to screen
both the mother's and the baby's blood for specified
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infectious diseases, which is commonly done by banks.
Additionally, the FDA requires all registered banks to
follow federal safety standards applicable to the
collection, processing, packaging, labeling, and
distribution of cord blood units, and conducts inspections
to monitor compliance. Umbilical cord blood banks must
also notify the FDA of any specific adverse reactions in
the units they process to prevent contamination.
Birth certificates
Certified birth certificates are required for acquisition
of personal documents such as Social Security cards for
newborns and for other personal documents for adults, such
as passports. There are 550,000 births in California
annually; another one million certified birth certificates
would be subject to the fee increase established in this
bill, for children and adults requiring additional vital
records documentation.
Arguments in support
UC states that by promoting public cord blood collection in
one of the most ethnically diverse states in the nation, AB
52 will expand the number of specific ethnic and
multicultural cord blood units in the national inventory
and increase the chance of a suitable match for
Californians in need of a transplant.
Writing on a previous version of the bill, the American
College of Obstetricians and Gynecologists states that due
to the high cost of testing and storing umbilical cord
blood, it is reasonable to fund cord blood banking efforts
with public dollars in order to increase the inventory of
usable cord blood units.
Arguments in opposition
DPH states that it opposes increases in fees for certified
copies of birth certificates that are not directly related
to vital records, and believes that vital record fees
should be reserved for upgrading and imaging of vital
records. DPH also expresses concern that AB 52 may
jeopardize a federal grant from the Health Resources and
Services Administration, which does not include UC in its
scope of work.
The Child Abuse Prevention Center (CAP Center) states that
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it opposes AB 52 unless amended to remove the increase in
birth certificate fees as a funding source for the UCBCP.
CAP Center states that birth certificate fees have long
been a source of funding for child abuse prevention and
intervention programs, and that adding to the fees for
other purposes may make it less feasible to further raise
them in the future for child abuse prevention. CAP argues
that, given that fees for death certificates are lower than
those for birth certificates, an increase in death
certificate fees would be a more appropriate funding source
for the bill.
StemCyte, a stem cell banking and products company, states
AB 52 does not provide sufficient guidance on the
administration of the program, does not provide limits on
the costs for cord blood banking, and creates additional
obstacles to cord blood banks.
Related bills
ACR 74 (Portantino) makes a number of legislative findings
and declarations related to public and private umbilical
cord blood collection as a means of providing treatment
for blood cancers and other diseases, and states that the
Legislature desires to find ways to help California gain a
viable public umbilical cord blood banking system to ensure
that all races and ethnicities have an equal probability of
finding a match when medically necessary.
Prior federal legislation:
H.R. 2520 (Smith, 2005) establishes a national umbilical
cord blood program and provides federal funding to expand
and administer umbilical cord blood transplants and
research.
Prior state legislation:
AB 34 (Portantino), Chapter 516, Statutes of 2007, directs
DPH to establish the UCBCP by January 1, 2010, and permits
the UCBCP, to the extent public or private funds or grants
are identified, to contract with blood banks that are
licensed and accredited to provide cord blood storage
services.
SB 962 (Migden), Chapter 517, Statutes of 2007, requires
DPH to provide umbilical cord blood samples to the Birth
Defect Monitoring Program, for storage and research, as
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specified.
SB 1555 (Speier), Chapter 484, Statutes of 2006, requires
blood banks to be licensed in order to provide umbilical
cord blood banking storage services, and directs the
Department of Health Services (now DPH) to conduct the
Umbilical Blood Community Awareness Campaign, contingent
upon private funding.
SB 253 Ortiz, Chapter 789, Statutes of 2002, permits all
forms of stem cell research in 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.
PRIOR ACTIONS
Assembly Floor: 68-8
Assembly Appropriations:13-2
Assembly Health: 14-2
COMMENTS
This bill was heard by this committee on August 4, 2010,
where it failed on a 3 - 1 vote and was granted
reconsideration. The author agreed to accept the
amendments summarized in Comments 1 through 6 below, which
have been incorporated in the bill that is before the
committee for the reconsideration vote. The author
additionally accepted amendments to allow UC three years to
encumber or expend funds that are appropriated for the cord
blood banking program and to clarify that the program may
make available cord blood units that are not suitable for
transplant for research purposes. These amendments have
also been incorporated in the bill that is before the
committee for the reconsideration vote.
1. Extension of sunset. As drafted, the bill would extend
the sunset on the UCBCP from January 1, 2015 to January 1,
2022. This would create a sunset of 11 years for the
program, as administered by UC. Given that the bill would
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make a major change in the administration of the program, a
suggested amendment would be to create a seven-year sunset
for the program, as administered by UC, or January 1, 2018.
2. Funding provisions. Section 3 of the bill makes
implementation of the UCBCP contingent on the Controller's
finding that sufficient funds exist in the Fund, while
Section 4 makes implementation contingent on UC
determining, separately from the Controller, that
sufficient funds are appropriated. A recommended amendment
would be to delete the requirement that implementation is
contingent on UCs determination that adequate funding is
appropriated, and instead specify the level of funding that
the Controller must find has been collected, and make
implementation contingent on the Controller's determination
and appropriation of the funds by the Legislature.
3. Duties of UC. The June 24, 2009 version of the bill
would have imposed several specific duties on the UCBCP to
create umbilical cord blood collection targets, develop a
strategy to increase participation of hospitals in the
collection and storage of cord blood, and explore the
feasibility of making the program self-sustaining. A
recommended amendment would be to express the Legislature's
intent that UCs plan and implementation of the UCBCP
achieve these goals as well as the overall goal of
increasing the number of cord blood units available to
diverse populations.
4. Limits on fees for providing cord blood units. The
bill does not establish limits on how much UC may charge
patients, health care providers, and researchers for cord
blood units, or for services related to providing the
units, such as matching and testing blood units. Because
the bill would provide that UC would own cord blood units
collected under the UCBCP, the bill should express the
Legislature's intent that UC not charge more than its
reasonable and actual costs for storage, handling, and
providing units, and for related services.
5. Oversight of UCs plan and program. As drafted, the
bill does not provide for the review of UCs plan for
establishing and implementing the UCBCP, or contain a
mechanism to assure that the plan and implementation meet
the Legislature's intent that the program increase the
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number of high quality cord blood units from donors of
diverse ethnic groups, and achieve other goals and duties,
as outlined in Comments 3 and 4 above. Recommended
amendments would be to provide that funds shall be
appropriated for the implementation of the UCBCP to the
extent that UCs plan and implementation of the program meet
the Legislature's intent, and to request that UC submit
copies of the plan that it develops by July 1, 2011 to the
policy and fiscal committees of the Legislature.
6. Plan versus implementation of program. Staff suggest
additional amendments to clarify that UC would be requested
to prepare a plan to establish and administer the UCBCP by
July 1, 2011, regardless of funding, and to require it to
implement the program once moneys from the increased birth
certificate fee and other funds exceed a specific
threshold.
POSITIONS
Support: African American Blood Drive and Bone Marrow
Registry for Sickle Cell
Disease Awareness
Association of Northern California Oncologists
Blood Centers of California
City of Los Angeles
California Commission on the Status of Women
California Communities United Institute
Medical Oncology Association of Southern
California, Inc.
Planned Parenthood Affiliates of California
University of California
Based on a previous version of the bill:
American College of Obstetricians and
Gynecologists, District IX/CA
(sponsor)
American Federation of State, County and
Municipal Employees (AFSCME)
California Catholic Conference, Inc.
California Hospital Association
California Medical Association
California Nurse Midwives Association
California Nurses Association
California State University, Long Beach Nursing
Students (58 signatures)
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City of Hope
Joanne Pang Foundation
Kaiser Permanente
March of Dimes Foundation
National Marrow Donor Program
Project RACE
University of California, Sacramento
Oppose: California Department of Public Health
StemCyte International Cord Blood Center
Based on a previous version of the bill:
County Recorders Association of California
Child Abuse Prevention Center
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