BILL ANALYSIS
AB 1307
Page 1
ASSEMBLY THIRD READING
AB 1307 (Buchanan)
As Amended May 5, 2009
Majority vote
HEALTH 15-1 APPROPRIATIONS 11-1
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|Ayes:|Jones, Fletcher, Adams, |Ayes:|De Leon, Ammiano, Charles |
| |Block, Carter, Conway, De | |Calderon, Davis, Fuentes, |
| |La Torre, | |Hall, John A. Perez, Price, |
| |De Leon, Emmerson, | |Skinner, Solorio, Torlakson |
| |Hayashi, Hernandez, | | |
| |Bonnie Lowenthal, Nava, | | |
| |V. Manuel Perez, Salas | | |
| | | | |
|-----+--------------------------+-----+----------------------------|
|Nays:|Gaines |Nays:|Nielsen |
| | | | |
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SUMMARY : Requires the Department of Public Health (DPH) to
consider including in the Newborn Screening Program (NSP)
screening for all conditions recommended by the American College
of Medical Genetics (ACMG), as specified. Specifically, this
bill requires DPH to:
1)Consider including in the NSP screening for all conditions
that ACMG defines in its most recent recommendations as "core
panel" or "secondary targets," or by another advisory body
appointed by the Secretary of the United States (U.S.)
Department of Health and Human Services (DHHS) to make
recommendations for newborn screening.
2)Implement screening according to recommendations within one
year of receipt of the recommendations of ACMG or other
DHHS-approved entity, unless DPH determines the screening is
not necessary for advancing newborn health, and notifies the
appropriate committees of jurisdiction in the Legislature of
this determination.
EXISTING LAW :
1)Requires DPH screening of newborns to include numerous
specified disorders, and to provide information about these
AB 1307
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disorders and available testing resources to all women
receiving prenatal care and all women admitted to a hospital
for a delivery.
2)In regulations, requires each newborn to be tested for
specified genetic disorders, except if the parents object
based on personal beliefs.
3)Establishes the Genetic Disease Testing Fund (Fund) in the
State Treasury, states the intent of the Legislature that the
Fund be fully fee-supported, and authorizes DPH to collect
fees for screening tests.
FISCAL EFFECT : According to the Assembly Appropriations
Committee analysis, this bill has no direct fiscal impact.
COMMENTS : The author of this bill states that screening
newborns to detect genetic disorders such as sickle-cell anemia
and phenylketonuria can prevent severe disability, mental
retardation, or even death. The author states the development
of better screening tools prompted the federal Maternal and
Child Health Bureau of the Health Resources and Services
Administration (HRSA) to commission ACMG to prepare a report on
newborn screening and recommend a uniform panel of conditions
for which newborns should be screened. According to the author,
this bill is needed because greater uniformity among newborn
screening programs would benefit families, professionals, and
public health agencies. The author contends that newborn
screening may also save the state money on future medical costs
based on early detection and access to treatment of disorders.
Newborn screening in the U.S. is a state-based public health
program that began over 40 years ago. States and territories
require screening of all infants born in their jurisdiction for
disorders that may not otherwise be detected before
developmental disability or death occurs (babies with these
disorders typically appear normal at birth). According to DPH,
effective treatments are available for most, but not all,
diseases detected by NSP, and treatments may include special
diets or medications. ACMG examined costs and benefits of
newborn screening and concluded that most newborn screening
programs improve outcomes and reduce costs.
In 2006, the journal Genetics in Medicine published the ACMG
AB 1307
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guidelines for a uniform newborn screening panel and system,
which HRSA had requested. To develop these recommendations,
ACMG convened a group of newborn screening experts who evaluated
genetic conditions based on explicit criteria, surveyed hundreds
of experts from the U.S. and other countries, and applied
specified criteria to develop recommendations. The ACMG
workgroup categorized conditions as: 1) "core panel" (29
conditions); 2) "secondary targets," which means these
conditions are part of the differential diagnosis for conditions
on the core panel, are clinically significant but lack effective
treatment, or may have other clinical significance (25
conditions); and, 3) not appropriate for newborn screening.
According to DPH, California currently tests for 76 genetic
disorders, including all of the 29 disorders defined by ACMG as
core panel, and all except one of the conditions ACMG defines as
secondary targets. The secondary target for which NSP no longer
screens is galactokinase deficiency, which DPH states was
extremely rare and required a separate test. DPH states that
each year in California, approximately one in every 760 babies,
or a total of approximately 750 babies, are born with a genetic
disease detected by NSP.
DPH states disorders are evaluated for inclusion in the
screening program based on the following criteria: 1) important
health problem in terms of frequency, seriousness, and high
costs of care; 2) associated with disease/known symptoms; 3)
availability of effective treatment that improves quality of
life; 4) can be detected reliably and economically; and, 5)
existence of adequate methods of confirmation and follow-up.
DPH also states other considerations, including the number of
babies screened daily, may affect the decision to add disorders
to NSP. DPH states NSP will add one disorder, severe combined
immune deficiency, when the ACMG finalizes its recommendation.
NSP is also reviewing five lysosomal storage disorders for
consideration, and will consider implementing these tests when
ACMG and the March of Dimes officially recommend them.
Analysis Prepared by : Allegra Kim / HEALTH / (916) 319-2097
FN: 0000937