BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 395|
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THIRD READING
Bill No: AB 395
Author: Pan (D)
Amended: 05/27/11 in Assembly
Vote: 21
SENATE HEALTH COMMITTEE : 9-0, 7/6/11
AYES: Hernandez, Strickland, Alquist, Anderson, Blakeslee,
De León, DeSaulnier, Rubio, Wolk
SENATE APPROPRIATIONS COMMITTEE : 9-0, 8/25/11
AYES: Kehoe, Walters, Alquist, Emmerson, Lieu, Pavley,
Price, Runner, Steinberg
ASSEMBLY FLOOR : 71-4, 06/01/11 - See last page for vote
SUBJECT : Newborn screening program
SOURCE : March of Dimes
DIGEST : This bill requires the Department of Public
Health to expand statewide screening of newborns to include
screening for severe combined immunodeficiency (SCID) and
other T-cell lymphopenias detectable as a result of SCID.
ANALYSIS :
Existing law:
1. Declares the intent of the Legislature that the state's
hereditary disorders program activities are to be fully
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supported by fees collected for services provided by the
program, unless otherwise provided.
2. Requires Department of Public Health (DPH) to establish
a genetic disease unit to coordinate programs in the
area of genetic disease and evaluate and prepare
recommendations on the implementation of tests for the
detection of certain hereditary and congenital diseases.
3. Requires DPH to charge a fee for newborn screening and
follow-up services, and requires the amount of the fee
to be established pursuant to regulation and
periodically adjusted.
4. Requires that any fee charged for screening and
follow-up services provided to Medi-Cal eligible
persons, health care service plan enrollees, or persons
covered by disability insurance policies are to be paid
directly to the Genetic Disease Testing Fund, and are
subject to the terms and conditions of the health care
service plan or insurance coverage.
This bill requires DPH to expand statewide screening of
newborns to include screening for severe SCID and other
T-cell lymphopenias detectable as a result of SCID.
Background
SCID . The defining characteristic of SCID is the absence
of T-cells and, as a result, the lack of B-cell functions.
B-cells are specialized white blood cells made in the bone
marrow that fight infection. These genetic defects lead to
extreme susceptibility to serious illness. Unless these
defects are corrected, children are vulnerable to
opportunistic infections and will likely die before their
first or second birthday. In the past, children with this
disorder were kept in strict isolation, sometime in a
plastic isolator or "bubble." Now treatments are available
to significantly enhance the health outcomes of infants
with SCID who are presyptomatic or early symptomatic.
Based on national studies, stem cells from either umbilical
cord blood or bone marrow appears to be effective in
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significantly decreasing the morbidity and mortality for
children with a type of SCID caused by a mutated gene on
the X chromosome. According to the genetic disease
screening program, if the treatment is provided within 3.5
months of life, the long-term survival rate is 95 percent
and after 3.5 months it is 60 to 70 percent. When left
untreated, children rarely survive past the age of two.
Pilot project . Beginning in August of 2010, DPH has been
participating in a pilot project to test for SCID sponsored
by the Jeffrey Modell Foundation and the National
Institutes of Health. According to the March of Dimes, all
babies born in California since the pilot began have been
screened. Out of 235,686 babies screened, seven have been
identified as SCID babies. The pilot has also lead to the
identification of four other babies with T-cell
lymphopenia. Current data as a result of the pilot has
shown the rate of SCID to be 1 in 35,000 in California
while it was previously estimated to be 1 in 100,000.
Methodology for adding new conditions . According to DPH,
there is no national standard process to add a disorder to
a state's screening program. Some states will add a
disorder once it is recommended by the Secretary's Advisory
Committee on Heritable Disorders in Newborns and Children
(SACHDNC) but prior to official acceptance by the Health
and Human Services (HHS) Secretary, while other states wait
for the official acceptance by the HHS Secretary. In
California disorders have been added through the budget
process or through legislation directing the department to
add a specific disorder to the screening program.
In May 2010, Secretary Sebelius of the HHS adopted the
SACHDNC recommendation of the Uniform Screening Panel to
adopt the recommendation to add SCID as a core condition
and the related T-cell lymphocyte deficiencies to the list
of secondary targets.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
According to the Senate Appropriations Committee:
Fiscal Impact (in thousands)
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Major Provisions 2011-12 2012-13 2013-14 Fund
Increased DPH $2,600 $5,300 $5,300
Special*
testing costs
Fee revenue ($2,600) ($5,300) ($5,300)
Special*
Approximate Medi- $650 $1,300
$1,300General/**
Cal fee payments $650 $1,300 $1,300 Federal
Potential publicly likely in the tens of
thousands to General/
funded health program hundreds of thousands of
dollars Federal/
cost avoidance per child over time County
* Birth Defects Monitoring Program Fund
** Costs shared 50 percent federal funds, 50 percent
General Fund
SUPPORT : (Verified 8/25/11)
March of Dimes (source)
American Academy of Pediatrics, California
American College of Obstetricians and Gynecologists,
California
California Medical Association
Children's Advocacy Institute
Talecris Biotherapeutics
ARGUMENTS IN SUPPORT : The March of Dimes, the sponsor of
this bill, writes that, any disease affecting newborns that
can be detected and treated should be, and it is critical
that SCID be added to the California NBS Program. The
March of Dimes argues that the health benefits of screening
newborns for SCID are apparent, but screening would also
likely lead to economic relief in California as well. The
Children's Advocacy Institute writes that this bill makes
possible the identification of SCID shortly after birth,
allowing for timely, cost-effective treatment and could
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save the lives of children who are born with this
condition.
The American Academy of Pediatrics writes that early
screening for SCID is critically important as data shows
that SCID infants who receive a related donor bone marrow
transplant within the first 14 weeks of life are
significantly more likely to survive and have fewer
problems over time than those who receive transplants later
in infancy or who have already developed an infection.
ASSEMBLY FLOOR :
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Beall,
Block, Blumenfield, Bonilla, Bradford, Brownley,
Buchanan, Butler, Charles Calderon, Campos, Carter,
Cedillo, Chesbro, Conway, Cook, Davis, Dickinson, Eng,
Feuer, Fletcher, Fong, Fuentes, Furutani, Beth Gaines,
Galgiani, Gatto, Gordon, Grove, Hagman, Halderman, Hall,
Harkey, Hayashi, Roger Hernández, Hill, Huber, Hueso,
Huffman, Lara, Logue, Bonnie Lowenthal, Ma, Mendoza,
Miller, Mitchell, Monning, Morrell, Nestande, Nielsen,
Norby, Olsen, Pan, Perea, Portantino, Silva, Skinner,
Smyth, Solorio, Swanson, Torres, Valadao, Wagner,
Wieckowski, Williams, Yamada, John A. Pérez
NOES: Bill Berryhill, Donnelly, Jones, Knight
NO VOTE RECORDED: Garrick, Gorell, Jeffries, Mansoor, V.
Manuel Pérez
CTW:do 8/26/11 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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