BILL ANALYSIS Ó
SB 1095
Page 1
Date of Hearing: August 3, 2016
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez, Chair
SB 1095
(Pan) - As Amended August 1, 2016
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|Policy |Health |Vote:|17 - 0 |
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Urgency: No State Mandated Local Program: NoReimbursable: No
SUMMARY:
This bill requires the California Department of Public Health
(CDPH) to expand genetic disease screening of newborns to
include any additional disease adopted as part of the federal
Recommended Uniform Screening Panel (federal panel), as soon as
the disease is adopted.
FISCAL EFFECT:
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
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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,
cover 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 (GF/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).
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). When
considering whether to include additional diseases in the
federal panel, a federal advisory committee considers issues
such as the reliability of the screening test, the
availability of treatments, the benefits of early diagnosis,
and the anticipated impact on health outcomes from additional
screening. Specific information about the long-term impacts on
health outcomes or avoided health care costs are often not
available, because the diseases that are considered for
inclusion are rare and treatments are evolving rapidly.
However, new diseases are added when the advisory panel finds
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that there are benefits from screening, primarily the ability
to avoid long-term health consequences with early
intervention. Although it is not certain whether additional
screening and treatment is actually cost-saving when
considering the screening costs, it is reasonable to project
that early diagnosis made possible by screening for new
diseases will reduce health care costs in specific cases.
COMMENTS:
1)Purpose. This bill is intended to align California's Newborn
Screening Program with best practices nationally, as defined
by a federal advisory body. The author explains California's
current approach to reviewing and approving screening for
additional diseases has created a lag behind current medical
recommendations. Diseases added to the Recommended Universal
Screening Panel meet a number of strict criteria following a
robust, science-based study by experts. The author suggests
adopting new tests without delay into California's program is
a scientific, rather than political, solution to screening
newborns.
2)Background. State genetic disease screening programs test
babies for a number of rare and serious genetic conditions
that are often otherwise undetectable. The goal of the
program is to identify babies with these disorders and begin
treatment as early as possible. Hospitals collect small blood
spots on special paper by pricking a baby's heel, and the
specimens are sent to a laboratory for testing. In
California, the state laboratory within CDPH tracks each
specimen, arranges for testing of newborn blood spots through
contract laboratories, handles more complex confirmatory
testing, and provides follow-up services as necessary. The
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program currently tests for over 80 different genetic and
congenital disorders. Testing is mandatory but parents are
allowed to opt out for religious reasons. Nearly all babies
are screened through the program.
A federal expert committee, the Advisory Committee on
Heritable Disorders in Newborns and Children, advises the
Secretary of the U.S. Department of Health and Human Services
on the most appropriate application of universal newborn
screening tests, technologies, policies, guidelines, and
standards. The Committee recommends every newborn screening
program screen for certain core disorders and secondary
disorders. Since these are recommendations, not mandates,
screening protocols vary by state. CDPH has the authority to
add diseases administratively, but has not done so. Instead,
California has generally added new screening tests through
disease-specific legislation. This bill would obviate the need
for disease-specific legislation and keep California's panel
consistent with federal recommendations. It would add a
disease as soon as it is recommended by the Committee, which
is after a rigorous expert review process.
3)Support. This bill is supported by a number of public health,
children's health, health care provider, and disease advocacy
groups. It is sponsored by EveryLife Foundation for Rare
Diseases, a nonprofit that encourages biotech innovation for
rare disease treatments.
4)CDPH Opposition. This bill would add a disease as soon as the
disease is recommended by the Committee for inclusion in the
federal panel. CDPH is opposed to the bill unless amended to
recognize the required implementation time when a new disease
is added. Staff notes it appears reasonable to recognize
some implementation time, in order to ensure the state does
not incur unnecessary costs associated with attempting to
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"immediately" implement each new test, as well as to ensure
quality control.
Analysis Prepared by:Lisa Murawski / APPR. / (916)
319-2081