BILL ANALYSIS �
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 1731
AUTHOR: Block
AMENDED: May 25, 2012
HEARING DATE: June 27, 2012
CONSULTANT: Orr
SUBJECT : Newborn screening program: critical congenital heart
disease.
SUMMARY : Requires hospitals with licensed perinatal services to
offer pulse oximetry testing for newborns in order to screen for
critical congenital heart disease (CCHD).
Existing law:
1.Requires newborn screening (NBS) for certain preventable
heritable or congenital disorders leading to physical defects
or intellectual disabilities. Requires NBS for sickle cell
anemia, phenylketonuria, and severe combined immunodeficiency
(SCID). Also requires tandem mass spectrometry screening in
newborns for fatty acid oxidation, amino acid and organic acid
disorders, and congenital adrenal hyperplasia. Under
regulation, requires testing for hereditary
hemoglobinopathies, primary congenital hypothyroidism, and
galactosemia.
2.Requires the California Department of Public Health (CDPH) to
develop a genetic disease testing program. Requires CDPH to
establish a genetic disease unit to coordinate programs in the
area of genetic disease and evaluate and prepare
recommendations on the implementation of tests for the
detection of certain hereditary and congenital diseases.
Requires CDPH to provide genetic screening and follow-up
services. Allows CDPH to provide laboratory testing facilities
or work with qualified outside labs to conduct testing.
3.Requires CDPH to charge a fee for NBS and follow-up services,
and requires the amount of the fee to be established pursuant
to regulation and periodically adjusted. Requires any fee
charged for screening and follow-up services provided to
Medi-Cal-eligible persons, health care service plan enrollees,
or persons covered by disability insurance policies be paid
directly to the Genetic Disease Testing Fund, subject to the
terms and conditions of the health care service plan or
Continued---
AB 1731 | Page 2
insurance coverage.
4.Establishes the Newborn Hearing Screening Program (NHSP) under
the Children's Medical Services (CMS) Branch within the
California Department of Health Care Services (DHCS). The NHSP
helps identify hearing loss in infants and guide families to
the appropriate services needed to develop communication
skills. Requires all hospitals with licensed perinatal
services to provide inpatient hearing screening for all
newborns, with parental permission, prior to hospital
discharge.
This bill:
1.Requires a general acute care hospital with licensed perinatal
services to offer newborns a pulse oximetry test to identify
CCHD, using protocols approved by DHCS or its designee.
Requires the testing protocols to be consistent with those of
the Centers for Disease Control and Prevention (CDC).
2.Requires these hospitals to develop a screening program that
provides competent CCHD screening, utilize appropriate staff
and equipment for administering the testing, complete the
testing prior to the newborn's discharge from a newborn
nursery unit, refer infants with abnormal screening results
for appropriate care, maintain and report data as required by
DHCS, and provide physician and family-parent education.
3.Requires DHCS to begin phasing in this test on or after July
1, 2013, and achieve 100 percent participation by 2016.
4.Requires the test be performed by a licensed health
professional, as described, or an appropriately trained
individual, as described.
5.Allows parents of a newborn to object to the test on the
grounds that the test is in violation of his or her beliefs.
6.Makes findings and declarations about the prevalence of CCHDs.
FISCAL EFFECT : According to the Assembly Appropriations
committee:
1.One-time implementation costs of $75,000 (50 percent General
Fund (GF), 50 percent federal funds) to consult with
stakeholders, develop a phase-in plan, review research and
guidance, and work with relevant federal agencies.
2.Minor one-time costs for training and process development, as
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well as ongoing costs to University of California hospitals in
the range of $100,000 system-wide.
3.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
percent GF, 51 percent federal funds) and follow-up care;
b. Potential offsetting cost savings in the range of
$350,000 (49 percent GF, 51 precent federal funds) annually
associated with earlier detection of heart defects among
Medi-Cal and HFP eligible babies; and
c. Uncertain, but potentially significant savings to
various health care and developmental services programs
from prevention of life-long disability related to earlier
diagnosis.
1.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
the absence of this bill.
PRIOR VOTES :
Assembly Health: 15- 4
Assembly Appropriations:12- 5
Assembly Floor: 62- 13
COMMENTS :
1.Author's statement. AB 1731 is a bill that will save lives.
This measure will ensure that newborns are screened for
congenital heart disease (CHD), which involves defects of the
walls, valves, arteries or veins of the heart and occurs in 7
to 9 of every 1,000 live births in the United States. About a
quarter of those babies have a critical illness which could be
detected and potentially treated by measuring blood oxygen
saturation. This bill is needed to comply with a 2011
recommendation from the Health and Human Services Secretary's
Advisory Committee on Heritable Disorders in Newborns and
Children (SACHDNC) that newborns be screened for CCHD. AB 1731
will bring California's newborn screening programs into
alignment with the most up-to-date public health standards and
practices. Many newborn lives could potentially be saved by
AB 1731 | Page 4
early detection and treatment of CCHD. This simple, $3 test
potentially saves millions in long-term medical costs, spares
families unnecessary trauma, and prevents infant death.
2.CHD. According to the SACHDNC, CHD is an overarching term
describing a spectrum of clinical outcomes derived from any
number of defects present in the structure of the heart at
birth. Specific defects may include the interior walls of the
heart, valves inside the heart or the arteries and veins that
carry blood to the heart or out to the body. Some defects are
caused by changes in genes or chromosomes, but the cause of
most heart defects is unknown. CHD is the most common cause of
death in the first year of life, with defects accounting for 3
percent of all infant deaths and more than 40 percent of all
deaths due to congenital malformations.
According to the CDC, CCHDs are a specific group of CHDs that
cause severe and life-threatening symptoms and require
intervention within the first few days or first year of life.
Infants with CCHDs are at significant risk for death or
disability early in life if their condition is not diagnosed
soon after birth. There are 7 specific defects that are
typically classified as CCHDs, which represent about 17 to 31
percent of all CHDs. In the United States, about 4,800 (or
11.6 per 10,000) babies born every year have one of these 7
CCHDs.
3.Pulse oximetry screening. According to the CDC, pulse oximetry
is a simple bedside test to determine the amount of oxygen in
a baby's blood and the baby's pulse rate. Low levels of oxygen
in the blood can be a sign of a CCHD. The test is done using a
machine called a pulse oximeter, with sensors placed on the
baby's skin. Screening is performed when a baby is 24 to 48
hours of age, and results are obtained at the bedside. Pulse
oximetry screening can identify some, but not necessarily all,
infants with a CCHD before they show signs of the defect.
Pulse oximetry screening does not replace a complete history
and physical examination, which sometimes can detect a CCHD
before the development of low levels of oxygen in the blood.
4.NBS. According to the CDC, NBS programs test infants shortly
after birth for serious or life-threatening metabolic
disorders, endocrine disorders and other conditions like
cystic fibrosis that, when detected early, might be managed or
treated to prevent death, disability, or other severe
consequences such as intellectual disabilities. These tests
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are typically conducted using a few drops of blood collected
from newborns before hospital discharge that are spotted on
filter paper cards. Although NBS programs are primarily funded
by user fees, state and federal public health system funding
often is necessary to support the comprehensive programs,
which include education, laboratory screening, follow-up and
tracking, diagnosis, treatment and management, and evaluation.
The NBS program in California is administered by CDPH.
California also maintains the NHSP, established as a result of
AB 2780 (Gallegos), Chapter 310, Statutes of 1998. This law
requires a comprehensive hearing screening program for the
early detection of hearing loss in newborns and infants,
access to diagnostic evaluations and follow-up services, and
provisions for data collection and reporting. DHCS,
specifically the CMS Branch, has responsibility for the
implementation and oversight of this program. Families of
infants delivered in general acute care hospitals with
licensed perinatal services which have been certified by DHCS
to participate in the NHSP have the opportunity to have their
baby's hearing screened at the point-of-care. Infants who do
not pass the screening in the hospital are referred for
additional testing after discharge.
5.Uniform screening panel. In 2010, the Secretary of the U.S.
Department of Health and Human Services (HHS) Kathleen
Sebelius adopted the SACHDNC recommendation to create a
Recommended Uniform Screening Panel (RUSP), which included
screening for 30 core conditions and reporting 26 secondary
conditions as a national standard for NBS programs. The list
of core and secondary conditions includes several types of
congenital disorders and testing for hearing loss and SCID.
On September 17, 2010, SACHDNC recommended that the HHS
Secretary add screening for CCHDs to the RUSP. After an
initial rejection, the HHS Secretary approved this
recommendation on September 21, 2011. In her approval letter,
the HHS Secretary noted that she is committed to advancing
screening for CCHD, but evidence gaps remain about the public
health impact of universal screening for CCHD, which she
believed deserved closer attention. Specifically, she claimed
it would be beneficial to states, health care facilities, and
individual clinicians to have the SACHDNC, the federal Health
Resources and Services Administration (HRSA) and other public
health experts provide information about a number of issues
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including determining the impacts to state health departments
to implement this new screening and ensuring that all babies
will receive screenings and their results communicated with
their providers. She also recommended that HRSA guide the
development of screening standards and infrastructure needed
for the implementation of a public health approach to bedside
screenings for CCHDs, to address these evidence gaps.
6.Methodology for adding new conditions. There is no federal
requirement to add a disorder to a state's screening program.
In California, disorders have been added through legislation
or administratively by the CDPH Director. While California
typically waits for the official acceptance of the disease by
the HHS Secretary, CDPH may also evaluate additional disorders
for addition into the NBS program using specified criteria.
Currently, California screens for over 70 conditions.
7.Related legislation. SB 1072 (Strickland) would have required
CDPH to expand statewide screening of newborns to include
screening for two types of lysosomal storage diseases. AB
1072 was held in the Senate Appropriations Committee.
8.Prior legislation. SB 395 (Pan), Chapter 461, Statutes of
2011, expanded statewide NBS to include screening for SCID.
AB 1307 (Buchanan) of 2009 would have required CDPH to
consider including conditions recommended by the American
College of Medical Genetics or other specified entities in the
NBS program. AB 1307 died in the Senate Appropriations
Committee.
SB 1748 (Figueroa) of 2006, would have added biotinidase and
cystic fibrosis to the existing expansion of the statewide NBS
program. SB 1748 died in the Assembly Appropriations
Committee. Provisions enacted through 2006-07 budget trailer
bills.
AB 2651 (Jones ) Chapter 335, Statutes of 2006, requires every
general acute care hospital with licensed perinatal services,
as specified, on or after January 1, 2008, to administer a
hearing screening test to every newborn, as specified.
SB 1103 (Committee on Budget and Fiscal Review), Chapter 228,
Statutes of 2004, expanded statewide screening of newborns to
include tandem mass spectrometry screening for fatty acid
oxidation, amino acid, organic acid disorders, and congenital
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adrenal hyperplasia.
AB 442 (Committee on Budget), Chapter 1161, Statutes of 2002,
required hospitals to collect fees associated with any tests
conducted under the state's NBS program.
AB 2427 (Kuehl) Chapter 803, Statutes of 2000, appropriated
$3.9 million from the Genetic Disease Testing Fund in order to
support the cost of a trial program to use tandem mass
spectrometry testing to detect additional hereditary
disorders.
SB 537 (Greene), Chapter 1011, Statutes of 1998, required CDPH
to establish a program to provide extended newborn genetic
screening services for persons who elect to have, and pay for,
the additional screening.
AB 2780, the Health Services Budget Act, established the NHSP
to provide hearing screening tests for children at risk for
deafness and a system to provide follow-up and assessment
services.
9.Support. The March of Dimes is sponsoring this bill and
believes this screening is cost effective and easy to
implement. They claim that an estimated 30 babies die each
year in California due to undiagnosed CCHD. They cite the
experience of Santa Clara Valley Medical Center, where their
CCHD screening program has screened 12,000 babies at an
approximate cost of $3.00 per baby over the past few years,
and identified 6 babies with CCHD, 3 of which would have been
sent home undiagnosed had there not been pulse oximetry
screening. March of Dimes claims that when screening is
implemented with protocols consistent with the CDC's
protocols, there will be a low false-positive rate, and
asserts that this screening will likely lead to cost savings
as fewer cardiac ultrasounds would be ordered because of the
combination of the examination and screening.
10.Opposition. The California Hospital Association (CHA)
appreciates the bill's intent but suggests we be mindful of
the impact that a new mandate will have on hospitals, health
care professionals, and our state's health oversight
infrastructure and financing capacity. CHA opposes the bill
because they claim the bill is missing many necessary and
critical components of a screening program, including no
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uniformity of protocol, lack of data collection, and no
reimbursement for specialty equipment and supplies.
11.Policy comment. As mentioned above, CDPH currently
administers the state's NBS program, where blood samples are
obtained at the hospital and testing is performed offsite in a
laboratory. DHCS administers the NHSP, which is performed at
bedside similar to the pulse oximetry screening. The bedside
nature and lack of involvement of the CDPH's centralized lab
for the testing and interpreting of pulse oximetry test
results seemed to signal that DHCS would be the appropriate
state entity to oversee surveillance of this new test.
However, since CDPH has more experience with disease
surveillance and more involvement with a range of congenital
conditions in newborns by virtue of their comprehensive NBS
program, it could be argued that CDPH would be more
appropriate. The author may wish to reexamine this provision
and grant CDPH the authority to incorporate this screening
within their existing NBS program.
SUPPORT AND OPPOSITION :
Support: March of Dimes Foundation (sponsor)
The American College of Obstetricians and
Gynecologists, District IX California
American Heart Association
The Arc and United Cerebral Palsy in California
Association of Regional Center Agencies
California Medical Association
California Chapter of the American College of
Cardiology
Cisco Systems
Kaiser Permanente (if amended)
MCAH Action
Mended Little Hearts
Santa Clara County Board of Supervisors
Oppose: California Hospital Association
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