BILL ANALYSIS �
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|SENATE RULES COMMITTEE | AB 1559|
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THIRD READING
Bill No: AB 1559
Author: Pan (D), et al.
Amended: 8/19/14 in Senate
Vote: 21
SENATE HEALTH COMMITTEE : 8-0, 6/18/14
AYES: Hernandez, Morrell, Beall, DeSaulnier, Evans, Monning,
Nielsen, Wolk
NO VOTE RECORDED: De Le�n
SENATE APPROPRIATIONS COMMITTEE : 5-0, 8/14/14
AYES: De Le�n, Hill, Lara, Padilla, Steinberg
NO VOTE RECORDED: Walters, Gaines
ASSEMBLY FLOOR : 79-0, 5/28/14 - See last page for vote
SUBJECT : Newborn screening program
SOURCE : The Myelin Project
DIGEST : This bill, until January 1, 2018, requires the
Department of Public Health (DPH) to expand statewide screening
of newborns to include screening for adrenoleukodystrophy (ALD)
as soon as possible.
ANALYSIS : Existing law:
1.Requires DPH to establish a genetic disease unit to coordinate
all DPH programs in the area of genetic disease that promotes
a statewide program of information, testing, and counseling
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services, and designates tests and regulations to be used in
executing this program, and designates tests and regulations
used in executing the California Newborn Screening Program
(CNSP).
2.Requires DPH to provide genetic screening and follow-up
services. Allows DPH to provide laboratory (lab) testing
facilities or work with qualified outside labs to conduct
testing.
3.Requires DPH to charge a fee for newborn screening and
follow-up services, and requires the amount of the fee to be
periodically adjusted in order to meet the costs of CNSP.
4.Requires DPH to evaluate and prepare recommendations on the
implementation of tests for the detection of hereditary and
congenital diseases, including, but not limited to,
biotinidase deficiency and cystic fibrosis. Requires DPH to
also evaluate and prepare recommendations on the availability
and effectiveness of preventative follow-up interventions,
including the use of specialized medically necessary dietary
products.
5.Requires statewide screening of newborns to include tandem
mass spectrometry screening for fatty acid oxidation, amino
acid, and organic acid disorders and congenital adrenal
hyperplasia. Also requires screening of newborns to include
screening for severe combined immunodeficiency, as soon as
possible.
This bill, until January 1, 2018, requires DPH to add screening
for ALD to the CNSP as soon as possible.
Background
Adrenoleukodystrophy . ALD can cause injury to the brain,
nerves, and adrenal glands. The first signs of ALD are
behavioral and rapidly lead to a vegetative state and ultimately
death. The childhood form is the most severe and affects boys
between the ages of four and eight years old. The slightly
milder adult version affects men in their 20s and 30s. Unless
treated before symptoms show, children affected with ALD will
die within a few months to a few years. Early detection and
treatment provides dramatically better quality of life for the
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affected individuals and their families. Cord blood and bone
marrow transplants performed at a very early stage in the
disease have proven to treat and heal the patient, enabling a
healthy and long life. An August 26, 2000, article, "Long-term
effect of bone-marrow transplantation for childhood-onset
cerebral X-linked adrenoleukodystrophy," in the Lancet medical
journal found the long-term beneficial effect of bone marrow
transplantation when the procedure is done at an early stage of
the disease.
CNSP . According to DPH's Internet Web site, newborn screening
is recognized nationally as an essential preventive health
measure. All states in the nation and the District of Columbia
have established newborn screening programs. Disorders screened
for by the program have varying degrees of severity. If
identified early, many conditions can be treated before they
cause serious health problems. Prior to leaving the hospital, a
few drops of blood from the newborn's heel are collected on
filter paper. Parents can get the test results from the baby's
doctor or clinic, which take about two weeks. If the baby needs
more tests, parents will get a letter or a phone call a few days
after discharge from the hospital. Positive test results are
immediately telephoned to a follow-up coordinator at one of the
Newborn Screening Area Service Centers throughout the state.
The coordinator contacts the newborn's physician to arrange for
repeat testing. If repeat testing determines that the baby has
a disorder, the coordinator will supply the latest clinical
information on diagnosis and treatment and assist with referrals
to special care clinics. Currently, the cost of the test is
$111.70. Medi-Cal, health plans, and most private insurance
will pay for the test.
Adding new screenings . According to DPH, California, like most
states, follows recommendations from the federal Health and
Human Services' (HHS) Discretionary Advisory Committee on
Heritable Disorders in Newborns and Children (DACHDNC) and waits
for the final approval from the HHS Secretary before requiring a
new screening. Because disorders are not officially part of the
Recommended Uniform Screening Panel (RUSP) until they are
approved by the Secretary, states do not generally implement
screenings before the final approval. While DPH's Director has
the authority to add new disorders administratively, in the past
new disorders have been added after final federal approval
through legislation in conjunction with a fee increase to
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support and maintain the screening expansion. CNSP statute does
not currently require screening for any disorders that are not
on the RUSP.
In January 2014, the DACHDNC voted to move ALD newborn screening
to an external evidence review committee. Approval from the
review committee is expected in early 2015, after which the HHS
Secretary would need to give final approval. There have been
instances in the past where the HHS Secretary rejected adding a
screening to the RUSP even after the review committee gave its
approval.
Prior Legislation
SB 224 (Walters, of 2013) would have required DPH, until January
1, 2019, to expand the screening of newborns in Orange County to
include screening for Krabbe disease. This bill was held in the
Assembly Appropriations Committee.
SB 1072 (Strickland, of 2012) would have required DPH, until
January 1, 2018, to expand statewide screening of newborns to
include screening for Hurler syndrome and Krabbe disease. This
bill was held in the Senate Appropriations Committee.
SB 1731 (Block, Chapter 336, Statutes of 2012) established the
Newborn Critical Congenital Heart Disease (CCHD) Screening
Program and required hospitals, beginning July 1, 2013, to offer
a pulse oximetry test for the identification of CCHD to parents
of newborns prior to discharge.
AB 395 (Pan, Chapter 461, Statutes of 2011) expanded statewide
screening of newborns to include screening for severe combined
immunodeficiency.
SB 1103 (Committee on Budget and Fiscal Review) Chapter 228,
Statutes of 2004, expanded statewide screening of newborns to
include tandem mass spectrometry screening for fatty acid
oxidation, amino acid, organic acid disorders, and congenital
adrenal hyperplasia.
FISCAL EFFECT : Appropriation: Yes Fiscal Com.: Yes
Local: No
According to the Senate Appropriations Committee:
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One-time costs of about $2 million for technical and
administrative activities to add ALD to the newborn screening
program (Genetic Disease Testing Fund).
Annual screening costs of $4.7 million per year, covered by
fees (Genetic Disease Testing Fund). Adding ALD to the
newborn screening program requires DPH to raise the fee
charged for screening by $11 per birth.
Increased costs or about $2.6 million per year to the Medi-Cal
program to pay the fees charged to support the newborn
screening program for births paid for by Medi-Cal (General
Fund and federal funds).
Increased costs of about $50,000 per year to CalPERS to pay
the fees charged to support the newborn screening program for
births paid for by CalPERS (various funds).
Likely long-term savings due to improved clinical outcomes
from early testing and treatment (various funds). According
to information provided by physicians treating children with
ALD, clinical outcomes can be greatly improved by early
diagnosis and treatment. Without screening for ALD, a
diagnosis often is not made until serious symptoms have
occurred. At that point, treatment is much less effective and
the child is at high risk for death or permanent disability.
On the other hand, if treatment is provided at the first sign
that ALD is occurring (through an MRI diagnosis, before
clinical symptoms are observed) long-term outcomes are greatly
improved.
SUPPORT : (Verified 8/19/14)
The Myelin Project (source)
Adrenoleukodystrophy Foundation
Be A Hero Become A Donor Foundation
Brian's Hope
California Professional Firefighters
Croda International
Fight ALD - Fighting Illness through Education
International Pemphigus & Pemphigoid Foundation
Moser Center for Leukodystrophies at Kennedy Krieger Institute
at Johns Hopkins Medical School
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Stop ALD Foundation
University of Minnesota, Pediatric Blood and Marrow
Transplantation
AFSCME, AFL-CIO
California Academy of Physician Assistants
California Healthcare Institute
Children's Hospital and Research Center Oakland
Corpus Christi Parish
Duke University Pediatric Blood and Marrow Transplant Program
and Carolinas Cord
Blood Bank
OPPOSITION : (Verified 8/19/14)
Department of Finance
ARGUMENTS IN SUPPORT : Supporters argue that early detection of
ALD is crucial and helps avoid undue suffering, as well as
emotional and financial costs associated with treatment and care
of the full onset of ALD. They further argue that newborn
screening for ALD is simple, accurate, and cost-effective, using
blood spots already used for screening of other diseases, and
that treatment is most effective if begun before symptoms first
appear.
ASSEMBLY FLOOR : 79-0, 5/28/14
AYES: Achadjian, Alejo, Allen, Ammiano, Bigelow, Bloom,
Bocanegra, Bonilla, Bonta, Bradford, Brown, Buchanan, Ian
Calderon, Campos, Chau, Ch�vez, Chesbro, Conway, Cooley,
Dababneh, Dahle, Daly, Dickinson, Donnelly, Eggman, Fong, Fox,
Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gonzalez, Gordon,
Gorell, Gray, Grove, Hagman, Hall, Harkey, Roger Hern�ndez,
Holden, Jones, Jones-Sawyer, Levine, Linder, Logue, Lowenthal,
Maienschein, Mansoor, Medina, Melendez, Mullin, Muratsuchi,
Nazarian, Nestande, Olsen, Pan, Patterson, Perea, John A.
P�rez, V. Manuel P�rez, Quirk, Quirk-Silva, Rendon,
Ridley-Thomas, Rodriguez, Salas, Skinner, Stone, Ting, Wagner,
Waldron, Weber, Wieckowski, Wilk, Williams, Yamada, Atkins
NO VOTE RECORDED: Vacancy
JL:nl 8/19/14 Senate Floor Analyses
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SUPPORT/OPPOSITION: SEE ABOVE
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