BILL ANALYSIS Ó
AB 1731
Page 1
Date of Hearing: May 2, 2012
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Felipe Fuentes, Chair
AB 1731 (Block) - As Amended: April 24, 2012
Policy Committee: HealthVote:15-4
Urgency: No State Mandated Local Program:
No Reimbursable: No
SUMMARY
This bill requires hospitals to offer screening for Critical
Congenital Heart Disorders (CCHD) using pulse oximetry.
Specifically, this bill:
1)Requires hospitals with licensed perinatal services to offer
to parents of a newborn, prior to discharge, a pulse oximetry
test for the identification of CCHD.
2)Requires DHCS to begin phasing in implementation of a
comprehensive hospital-based CCHD screening program on or
after July 1, 2013, and achieve a 100-percent participation
rate by 2016.
3)Requires hospitals to use screening protocols developed by the
Centers for Disease Control and Prevention and to provide
competent CCHD screening, including appropriate staff,
equipment, follow-up, referral, and physician and
family-parent education.
FISCAL EFFECT
1)One-time costs for program development of $300,000 (50% GF,
50% funds) to consult with stakeholders, develop a phase-in
plan, review research and guidance, and work with relevant
federal agencies.
2)Ongoing DHCS costs for program administration, potentially in
the range of $1 million annually (approximately 50% GF, 50%
funds).
It is unclear what would constitute a "comprehensive"
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screening program, but this estimate assumes that
comprehensive implies data collection, tracking, ensuring
referrals and follow-up care, development and distribution of
information, and quality improvement activities, similar to
current practice in the hospital-based newborn hearing
screening program. This estimate also assumes efficiencies
from leveraging existing infrastructure used for the existing
newborn hearing screening program, such as data collection and
IT infrastructure.
For comparison, the newborn hearing screening program's annual
budget is nearly $5 million in total funds, not including
Medi-Cal reimbursement costs; however, this program performs a
number of functions which would not be necessary for CCHD
given differences between the conditions and required
follow-up.
3)Minor one-time costs for training and process development, as
well as ongoing costs to University of California hospitals in
the range of $100,000 system-wide.
4)Additional costs that would be incurred, or saved, as a result
of this bill are not straightforward to estimate because the
extent to which screening is currently performed in hospitals
is not tracked. Assuming half of all babies in California are
currently screened, the following effects are projected:
a) $450,000 in increased Medi-Cal and Healthy Families
Program (HFP) cost pressure related to screening (49% GF,
51% federal funds) and follow-up care.
b) Potential offsetting cost savings in the range of
$350,000 (49% GF, 51% federal funds) annually associated
with earlier detection of heart defects among Medi-Cal and
HFP eligible babies.
c) Uncertain, but potentially significant savings to
various health care and developmental services programs
from prevention of life-long disability related to earlier
diagnosis of approximately 75 babies with CCHD who would
otherwise be diagnosed late.
5)Ongoing administrative costs to hospitals could range from
negligible up to several thousand dollars per hospital,
depending whether the hospital has initiated CCHD screening in
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absence of this bill.
COMMENTS
1)Rationale . According to the author, CCHD is a group of
defects that cause severe and life-threatening symptoms and
require intervention within the first days or first year of
life. He states that undetected CCHD kills 30 babies every
year in California, because babies with CCHD can appear
healthy and be discharged without being diagnosed. He also
believes it is appropriate to mandate universal screening in
the state, given pulse oximetry provides a low-cost,
non-invasive method to screen for CCHD, and given the federal
Health and Human Services (HHS) Secretary in fall 2011
formally adopted the recommendation that all newborns be
screened.
2)Newborn Screening Tests. Both government entities and
non-governmental groups such as the American Academy of
Pediatrics develop recommendations on newborn screening. The
relevant federal entity is the HHS Secretary's Advisory
Committee on Heritable Disorders in Newborns and Children.
The Committee reviews evidence and makes recommendations to
the Secretary on the addition of conditions or techniques to a
Recommended Uniform Screening Panel (panel), and the Secretary
can accept or reject the recommendation.
Currently, two models of newborn screening exist in
California. The California Department of Public Health (CDPH)
administers the Genetic Disease Screening Program, which uses
a system of regional and state laboratories to detect genetic
conditions by analyzing blood samples. DHCS administers the
Newborn Hearing Screening Program, a hospital-based hearing
test for which administration and follow-up is tracked by
region for the entire newborn population. DHCS retained the
hearing program after the two departments split in 2007
because many infants who fail the hearing screen are linked up
with referrals and services through the California Childrens
Services program, which DHCS administers. CDPH also runs the
Birth Defects Monitoring Program, which tracks congenital
heart defects in a representative subset (about 40%) of births
in the state.
Because CCHD screening is a hospital-based test, it seems to
most closely resemble the hearing screening program at DHCS.
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However, as explained below, the optimal role of state
agencies with respect to CCHD is not well-defined.
3)Pulse oximetry screening for CCHD is an active area of
research and discussion across the country. Many hospitals use
pulse oximeters to measure oxygen saturation for a variety of
purposes, including monitoring babies in neonatal intensive
care units. Four states have mandated using pulse oximetry
for CCHD screening and others are considering it. The federal
Committee recommended adding it to the standard panel of tests
in 2010, and the federal HHS Secretary initially rejected the
addition, citing significant gaps in evidence that would
impede effective implementation. In September 2011, based on
additional information, the Secretary endorsed the
recommendation, adding CCHD to the panel, but indicated that
there were still a number of issues that needed further
research, including the role of state health departments.
4)Fiscal Concern: Role of the State . Since follow-up for CCHD is
done immediately at the hospital, the state role is less clear
than in other newborn screening programs. Not all neonatal
best practices with respect to screening and follow-up are
legislatively mandated and tracked by public health agencies;
many practices become the standard of care even in absence of
such oversight.
A work group composed of members of the Committee on Heritable
Disorders in Newborns and Children, the American Academy of
Pediatrics, the American College of Cardiology Foundation, and
the American Heart Association acknowledges that the public
health role is different for CCHD screening in a 2011 report:
"Follow-up for a positive screen result should be managed
by the hospital or birth center before discharge;
therefore, the role of public health agencies in CCHD
screening is different from that in the case of newborn
dried-blood-spot screening or newborn hearing screening.
However, public health agencies can play a central role in
quality assurance and surveillance. There are several
challenges to public health agencies' involvement with CCHD
screening, including the inability to collect real-time
screening data through health information exchange systems,
absence of the direct presence of public health personnel
in hospitals and birthing centers, and the financial and
staffing pressures within public health departments.
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Given the unique implementation challenges associated with
universal screening for CCHD, the Maryland Legislature
requested its State Advisory Council On Hereditary And
Congenital Disorders to provide recommendations on
implementing universal screening in that state. The Maryland
council's 2011 report also recommended quality assurance and
appropriate evaluation of positive results should be the
responsibility of the birthing hospital, not the public health
department. They recommended the public health agency role be
limited to data surveillance, program evaluation, education,
and technical assistance relating to quality assurance.
CCHD screening does not parallel other existing screening
tests, and the bill does not specify precisely what the role
of DHCS is in ensuring universal screening. The bill's
current language implies the role of DHCS is more expansive,
and costly, than may be warranted given the time frame and
hospital-based nature of the screening exam and follow-up. A
narrower definition that defines a more limited role for the
state based on the unique features of CCHD screening, as
discussed above, could reduce costs and clarify the role of
the state to ensuring universal screening.
Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081