BILL ANALYSIS Ó
AB 2399
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Date of Hearing: April 5, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 2399
(Nazarian) - As Amended March 28, 2016
SUBJECT: Pregnancy: umbilical cord blood: blood testing.
SUMMARY: Requires the Department of Public Health (DPH) to make
available the materials that are provided to expectant parents
regarding umbilical cord blood (UCB) storage and prenatal
testing and the materials provided to women and infants infected
with or exposed to human immunodeficiency virus (HIV) in
Medi-Cal threshold languages, as specified. Repeals existing
law making the implementation of UCB Community Awareness
Campaign by DPH contingent upon receiving sufficient private
donations. Extends the sunset of the public Umbilical Cord
Blood Collection Program (UCBCP), housed at the University of
California (UC), Davis and the $2 collected from the $18 dollar
issuance fee for birth certificates for the purposes of funding
the UCBCP, from January 1, 2018 to January 1, 2023.
EXISTING LAW:
1)Requires DPH, contingent upon sufficient private funding, to
conduct the Umbilical Cord Blood Community Awareness Campaign
to provide information regarding UCB banking options using
brochures, television, print media, and Internet Websites,
among other options, where appropriate to disseminate
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information to licensed prenatal care providers, Family PACT
providers, and pregnant women.
2)Requires DPH to establish an Internet Website to provide
information about umbilical cord blood banking options that is
accessible to prenatal care providers, pregnant women, and the
general public, and to undertake public education activities
related to UCB donation to targeted populations.
3)Requires DPH to develop standardized, objective information
about UCB 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.
4)Requires DPH, in consultation with the Office of AIDS and
other stakeholders, to develop culturally sensitive
informational material adequate to inform pregnant women, at
the time of labor or delivery, that they will be tested for
HIV, the routine nature of the test, the purpose, risks and
benefits of the test, and that she has the right to decline
the test.
5)Requires all managed care plans contracting with the
Department of Health Care Services (DHCS) to provide language
assistance services to limited-English-proficient (LEP)
Medic-Cal beneficiaries who are mandatorily enrolled in
managed care. Requires DHCS to determine when a LEP
population meets the requirement for translation services
using one of the following numeric thresholds:
a) A population group of at least 3,000 or 5% of the
beneficiary population, whichever is fewer, mandatory
managed care Medi-Cal beneficiaries, residing in the
service area, who indicate their primary language as other
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than English; or,
b) A population group of mandatory managed care Medi-Cal
beneficiaries, residing in the service area, who indicate
their primary language as other than English, and that meet
a concentration standard of 1,000 beneficiaries in a single
ZIP Code or 1,500 beneficiaries in two contiguous ZIP
Codes.
6)Requests the UC to develop a plan to establish and administer
the UCBCP for the purpose of collecting units of umbilical
cord blood for public use in transplantation and providing
nonclinical units for research pertaining to biology and new
clinical utilization of stem cells derived from the blood and
tissue of the placenta and umbilical cord.
7)Creates the Health Statistics Special Fund in the State
Treasury which collects various fees to be expended by the
State Registrar for the purposes of funding programs,
including the UCBCP, which sunsets on January 1, 2018.
8)Establishes a fee of $18 for certain applicants requesting a
certified copy of a birth or death certificate, two dollars of
which must be paid to the UCBCP, until January 1, 2018.
FISCAL EFFECT: This bill has not been analyzed by a fiscal
committee.
COMMENTS:
1)PURPOSE OF THIS BILL. According to the author, studies have
shown UCB to be a rich source of stem cells - stem cells that
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can be used to treat various genetic disorders that affect the
blood and immune system, or leukemia and other cancers. The
author notes that, according to the state's UCBCP, 40% of
Californians have never heard of UCB donation. The author
states this bill neither encourages nor discourages a pregnant
woman from publicly storing, privately storing, donating to
research, or discarding UCB, it simply requires DPH to roll
out the UCB Community Awareness Campaign that is already on
the books but has lacked the required private funding needed
to take effect. The author contends, along with the increase
in awareness, this bill also provides women with the
informational material in the language they know best by
requiring the materials to be made available in all 14 of the
languages used to satisfy the translation services
requirements for Medi-Cal managed care plans.
2)BACKGROUND.
a) UCB. UCB is a sample of blood taken from a newborn
baby's umbilical cord. It is a rich source of stem cells,
which are precursors to blood cells. As such, they have
been used to treat certain diseases of the blood and immune
system. The next largest group is inherited diseases (of
red blood cells, the immune system and certain metabolic
abnormalities). Stem cells from UCB also demonstrae the
potential to help conditions that have no cure today by
regenerating damaged tissue and restoring lost function
after an injury or illness.
b) The Umbilical Cord Blood Collection Program. The UCBCP,
administered by UC Davis Health System, is a statewide
public program designed to capture the genetic diversity of
Californians through the collection of UCB units for
unrelated transplantation. The program was created by AB
52 (Portantino), Chapter 529, Statutes of 2010, that funds
public UCB banking through an additional $2 fee on birth
certificate copies. The collection service is the state's
first comprehensive public system for collecting cord blood
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that is stored at an established, qualified UCB bank.
Parents donate their newborns' UCB and have it publicly
banked so it is available to anyone for lifesaving
transplantations.
UCB can be stored by both public and private cord blood
banks. Public UCB banks store UCB for the benefit of the
general public, and most U.S. cord blood banks coordinate
matching UCB to patients through the National Marrow Donor
Program. Private UCB banks are usually for-profit
organizations that store UCB for the exclusive use of the
donor or donor's relatives. Public UCB banking is
supported by the medical community. However, private UCB
banking is generally not recommended unless there is a
family history of specific genetic diseases.
c) The California Prenatal Screening Program (CPSP). CPSP
currently offers three screening tests to pregnant women in
order to identify individuals who are at increased risk for
carrying a fetus with a specific birth defect. The CPSP
provides pregnant women with a risk assessment for open
neural tube defects (NTD), Down syndrome (trisomy 21),
trisomy 18 and SLOS (Smith-Lemli-Opitz Syndrome) through
one or two blood tests. The screening test indicates risk,
but does not diagnose fetal birth defects. For women with
screening results indicating a high risk for a birth
defect, the CPSP provides free follow-up diagnostic
services at State-approved Prenatal Diagnosis Centers.
Services offered at these Centers include genetic
counseling, ultrasound, and amniocentesis. Participation in
the screening testing and follow-up services is voluntary.
The cost of the testing through the CPSP is $207.
d) The CPSP pamphlet. All pregnant women in California are
provided with a pamphlet created by DPH regarding the CPSP
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by their prenatal care provider. Over the years
legislation has been passed to update the pamphlet, and add
additional requirements, including information regarding
reproductive health and the environment, and information
about cord blood banking. Currently the pamphlet is
required to be available in Cantonese, English, Spanish and
Vietnamese. DPH provides the pamphlet to all prenatal care
providers free of charge.
e) Medi-Cal translation requirements. As noted in Existing
Law above, managed care plans contracting with DHCS provide
language assistance services to LEP Medi-Cal beneficiaries
who are mandatorily enrolled in managed care when a
regional LEP population meets the certain numeric
thresholds. The Medi-Cal threshold languages are:
English, Arabic, Armenian, Cambodian, Chinese, Farsi,
Hmong, Japanese, Korean, Laotian, Russian, Spanish,
Tagalog, and Vietnamese.
3)SUPPORT. The American Congress of Obstetricians and
Gynecologists (ACOG-IX) District IX - California supports this
bill stating, UCB, the blood that remains in the umbilical
cord and the placenta after birth, has proven to be a rich
source of stem cells which can be used to treat various
genetic disorders that affect the blood and immune system.
ACOG-IX notes that, according to the March of Dimes
Foundation, these stem cells can be used as a potentially
safer alternative for transplantation than bone marrow. UCB
can be safely collected at birth without any harm caused to
the mother or child whereas the bone marrow donor must undergo
a formal procedure usually requiring anesthesia and more
people are likely to find a match using UCB than individuals
that use bone morrow or blood transplantations, which require
an almost identical match to be successful. ACOG-IX concludes
that awareness of the ability to store UCB is low, especially
considering the potential benefits and this bill brings
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greater awareness to the storage of UCB by repealing the
private funding contingency clause.
UC supports this bill stating that an extension in the sunset
date for the UCBCP is a continued investment in the future of
our diverse state. UC notes that with resources provided
through collection of a $2 fee on birth certificate copies,
the UCBCP developed collections at 11 hospitals within five
metro target areas: Fresno, Los Angeles, Sacramento, San
Diego, and the San Francisco Bay area and has successfully
listed more than 1,200 cord blood units (with approximately
80% from minority and mixed-race heritage) on the national
registry. UC also notes that from the cord units collected
through the UCBCP, 21 have been used in life-saving
transplantations.
4)PREVIOUS LEGISLATION.
a) AB 52 requests UC to develop a plan to establish and
administer the UCBCP for the purpose of collecting units of
umbilical cord blood for public use, increases the fee for
birth certificate copies by $2 to provide funds to
implement the UCBCP, and requires the UC to implement the
plan, contingent on an unspecified amount of funds being
available in the UCBCP Fund.
b) SB 460 (Pavley), Chapter 667, Statutes of 2013, requires
DPH to include prescribed information regarding
environmental health in the California Prenatal Screening
patient educational information, and to post that
environmental health information on DPH's Internet Website.
Requires DPH to send a notice to all distributors of the
educational information that informs them of the change to
that information, and encourages obstetrician-gynecologists
and midwives to discuss environmental health with their
patients.
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REGISTERED SUPPORT / OPPOSITION:
Support
American Congress of Obstetricians and Gynecologists, District
IX - California
Breast Cancer Fund
University of California
Opposition
None on file.
Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097
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