BILL ANALYSIS Ó
SB 1095
Page 1
SENATE THIRD READING
SB
1095 (Pan)
As Amended August 15, 2016
Majority vote
SENATE VOTE: 39-0
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|Committee |Votes|Ayes |Noes |
| | | | |
| | | | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Health |17-0 |Wood, Maienschein, | |
| | |Bonilla, Burke, | |
| | |Campos, Chiu, Gomez, | |
| | |Roger Hernández, | |
| | |Lackey, Nazarian, | |
| | |Patterson, | |
| | | | |
| | | | |
| | |Ridley-Thomas, | |
| | |Rodriguez, Santiago, | |
| | |Steinorth, Thurmond, | |
| | |Waldron | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Appropriations |20-0 |Gonzalez, Bigelow, | |
| | |Bloom, Bonilla, | |
| | |Bonta, Calderon, | |
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| | |Chang, Daly, Eggman, | |
| | |Gallagher, Eduardo | |
| | |Garcia, Holden, | |
| | |Jones, Obernolte, | |
| | |Quirk, Santiago, | |
| | |Wagner, Weber, Wood, | |
| | |McCarty | |
| | | | |
| | | | |
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SUMMARY: Requires the Department of Public Health (DPH) to
expand statewide screening of newborns to include screening for
any disease that is detectable in blood samples within two years
of the disease being adopted by the federal Recommended Uniform
Screening Panel (RUSP).
EXISTING LAW:
1)Requires DPH to establish a genetic disease unit to coordinate
all DPH programs in the area of genetic disease that will
promote a statewide program of information, testing, and
counseling services and to have the responsibility of
designating tests and regulations to be used in executing this
program and to have the responsibility of designating tests
and regulations to be used in executing the California Newborn
Screening Program (CNSP).
2)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.
3)Requires statewide screening of newborns to include tandem
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mass spectrometry screening for fatty acid oxidation, amino
acid, and organic acid disorders and congenital adrenal
hyperplasia. Requires screening of newborns to include
screening for severe combined immunodeficiency, as soon as
possible.
4)Requires DPH to expand statewide screening of newborns to
include screening for adrenoleukodystrophy (ALD) as soon as
ALD is adopted by the federal RUSP.
FISCAL EFFECT: According to the Assembly Appropriations
Committee:
1)One-time costs of $2.4 million and ongoing costs of $4.3
million per year to screen for two diseases (MPS-1 and Pompe
disease) that have already been approved for inclusion in the
federal panel (Genetic Disease Testing Fund). The ongoing
costs would cover initial screening tests, follow-up tests for
positive results, and initial case management for confirmed
diagnoses. The Genetic Disease Screening Program is
fee-supported; most health insurance, including Medi-Cal,
covers the screening fee. The fee has increased pursuant to
the 2016-17 Budget Act, and is currently $130.25. Adding
these two conditions would require an additional fee increase
of about $9.
2)Ongoing costs of over $2 million per year for coverage of the
increased screening fee by the Medi-Cal program (General
Fund/federal). Medi-Cal covers the cost of the screening exam
and Medi-Cal pays for roughly 50% of the births in the state.
3)Unknown future costs to expand newborn screening program to
add screening tests for new diseases as they are adopted as
part of the federal panel (Genetic Disease Testing Fund).
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Costs vary by disease; recent additions have generally cost in
the low millions per condition, per year. Screening fees will
be adjusted to support the additional projected expenditures.
4)Potential long-term savings due to improved clinical outcomes
from early testing and treatment (various funds).
COMMENTS: According to the author, newborn screening for rare
diseases is a critical, cost-effective public health
intervention, as diagnosing diseases at birth leads to earlier
medical intervention. In turn, early treatment saves and
improves children's and families' lives and reduces medical
costs by eliminating or ameliorating the devastating
consequences of rare and treatable diseases. California's
current approach to reviewing and approving screening for
additional diseases has created a lag behind current medical
recommendations. A study in the journal Pediatrics found that
California saves $9.32 in health care costs for every dollar
spent on newborn screening.
In 1966 California began its CNSP with the testing of
phenylketonuria. Since its creation, the CNSP has been expanded
several times as new discoveries are made and tests developed
and now screens for more than 70 disorders. Diseases have been
continually added through regulation and legislation. The last
disease added by statute was ALD in 2014. ALD was added to the
RUSP in February of 2016.
The California Hospital Association states that the bill
provides a forward thinking approach to properly and
thoughtfully expanding newborn screening by providing that
California screen for diseases that are detectable in blood
samples and listed on the RUSP as certified by the Health and
Human Services (HHS) Secretary. The RUSP list is periodically
updated through a thorough, deliberative review process
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involving a committee of experts in newborn screening. By
allowing California to take advantage of the work done by these
medical experts, we can remove the obstacles to needed testing
and minimize the suffering that comes from untreated diseases.
The EveryLife Foundation for Rare Diseases (EveryLife) states
that the bill provides a much needed, practical, science-based
approach to improving public health for all of California's
Children. This bill allows for the earliest diagnosis of
disease and access to potentially life-saving and life-altering
treatments for babies. Early treatment is vital in ensuring the
best possible life-altering health outcomes for children. In
many cases, early detection can avert costly and risky medical
procedures later in life. A study in the journal Pediatrics
found that California saves $9.32 in health care costs for every
dollar spent on newborn screenings. EveryLife states that this
bill will ensure that babies born in California, particularly
those that will be affected by debilitating and life-threatening
diseases, are diagnosed and treated at the earliest age possible
and without unconscionable delay. This approach is critical for
improving health outcomes for children and providing the
brightest future for all babies born in California.
The California Right to Life, Inc. argues that this bill does
not correct the issue of the limited ability to opt out of the
screening program for religious beliefs or practices and may
even bring discrimination against parents or guardians who do
opt out.
DPH states that if it is required to expand the current Newborn
Screening program to include other diseases as soon as a disease
is adopted by the RUSP, it will need additional time to plan and
implement a quality screening program that addresses all of the
issues addressed in the public health feasibility and readiness
assessments provided to the Secretary of HHS as part of the
approval process for new RUSP diseases.
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Analysis Prepared by:
Paula Villescaz / HEALTH / (916) 319-2097 FN:
0004129