BILL ANALYSIS Ó
AB 395
Page 1
ASSEMBLY THIRD READING
AB 395 (Pan)
As Amended May 27, 2011
Majority vote
HEALTH 15-1 APPROPRIATIONS 12-5
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|Ayes:|Monning, Ammiano, Atkins, |Ayes:|Fuentes, Blumenfield, |
| |Bonilla, Eng, Garrick, | |Bradford, Charles |
| |Gordon, Hayashi, Roger | |Calderon, Campos, Davis, |
| |Hernández, Bonnie | |Gatto, Hall, Hill, Lara, |
| |Lowenthal, Nestande, Pan, | |Mitchell, Solorio |
| |V. Manuel Pérez, Smyth, | | |
| |Williams | | |
| | | | |
|-----+--------------------------+-----+--------------------------|
|Nays:|Logue |Nays:|Harkey, Donnelly, |
| | | |Nielsen, Norby, Wagner |
| | | | |
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SUMMARY : Adds a test for the detection of severe combined
immune deficiency (SCID) to the Newborn Screening (NBS) Program.
Specifically, this bill :
1)Requires the Department of Public Health (DPH) to expand
statewide screening of newborns to include screening for SCID
as soon as possible.
2)Adds this expansion to existing exemptions for information
technology contracts.
3)Requires the implementation of SCID screening to include
screening for other with T-cell lymphopenias as long as it can
be accomplished without additional costs or resources.
4)Deletes obsolete requirements for a report to the Legislature
that was due on July 1, 2006, with regard to the progress of
statewide screening for metabolic disorders.
FISCAL EFFECT : According to the Assembly Appropriations
Committee:
1)Annual estimated screening costs to the DPH NBS Program
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statewide of $5 million (special fund). This test is
estimated to cost $9.50 per child.
2)Annual estimated screening costs to the Medi-Cal Program of
$2.2 million Ý50% General Fund (GF)]. Medi-Cal pays for
approximately 45% of the births in the state, and reimburses
the NBS Program for screening cost associated with Medi-Cal
births. In addition, annual treatment costs to the Medi-Cal
Program for babies diagnosed with SCID are estimated to be in
the range of $250,000 annually (50% GF).
3)Annual treatment cost savings to the Medi-Cal Program from
early detection of SCID, potentially in the range of $1-2
million annually (50% GF). In the absence of early detection,
treatment costs for the handful of newborns in the Medi-Cal
Program with SCID annually are highly variable and can be
significant. There are documented cases where treatment costs
for a single infant diagnosed with SCID after three and a half
months exceeded $1 million
COMMENTS : According to the author, the purpose of this bill is
to add SCID to the NBS Program, making it the 30th disease that
is screened. The author argues this bill is needed to implement
the recommendations of the Secretary's Advisory Committee on
Heritable Disorders in Newborns and Children (SACHDNC) and
brings the NBS Program into alignment with the most up-to-date
research, technology, laboratory, and public health standards
and practices
Prior to leaving the hospital, a few drops of blood from the
newborn's heel are collected on filter paper. Currently, the
cost of the test is $102.75. Medi-Cal and most private
insurance will pay for the test. The sample is sent to one of
eight regional laboratories that contract with the DPH for
testing. Parents obtain the test results from the baby's doctor
or clinic. It takes about two weeks for the doctor to receive
the written results. If the baby needs more tests, parents will
get a letter or a phone call a few days after discharge from the
hospital. According to DPH, 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
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information on diagnosis and treatment and assist with referrals
to special care.
Disorders screened for by the NBS Program have varying degrees
of severity. If identified early many of these conditions can
be treated before they cause serious health problems.
Treatments may include medication, dietary supplements,
avoidance of fasting and/or special diet and comprehensive care
to reduce morbidity and mortality. Infants with severe T-cell
lymphopenia, including SCID, often appear normal at birth and
have no family history of immunodeficiency. According to the
March of Dimes, SCID is the most serious primary
immunodeficiency disorder. The defining characteristic is the
absence of T-cells and, as a result, lack of B-cell function,
the specialized white blood cells made in the bone marrow to
fight infection. These genetic defects lead to extreme
susceptibility to serious illness. Unless these defects are
corrected the child will die of opportunistic infections 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 several national studies, stem cell from either
umbilical cord blood or bone marrow appears to be effective in
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%, after 3.5 months it is 60%-70%. For
those with adenosine deaminase deficiency, which affects males
and females, enzyme replacement therapy may be an alternative
treatment.
In May 2010, Secretary Sibelius of the federal Health and Human
Services adopted the SACHDNC recommendation of a Uniform
Screening Panel which was to screen for the identified 29 core
conditions and report on the identified 25 secondary conditions
as a national standard and also adopted the recommendation to
add SCID as a core condition and the related T-cell lymphocyte
deficiencies to the list of secondary targets which updated the
Recommended Uniform Screening Panel to 30 core conditions and
reporting on 26 secondary conditions.
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Analysis Prepared by : Marjorie Swartz / HEALTH / (916)
319-2097
FN: 0001055