BILL ANALYSIS Ó
------------------------------------------------------------
|SENATE RULES COMMITTEE | AB 1731|
|Office of Senate Floor Analyses | |
|1020 N Street, Suite 524 | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
------------------------------------------------------------
THIRD READING
Bill No: AB 1731
Author: Block (D)
Amended: 8/24/12 in Senate
Vote: 21
SENATE HEALTH COMMITTEE : 8-0, 6/27/12
AYES: Hernandez, Harman, Alquist, Anderson, Blakeslee,
DeSaulnier, Rubio, Wolk
NO VOTE RECORDED: De León
SENATE APPROPRIATIONS COMMITTEE : 7-0, 8/16/12
AYES: Kehoe, Walters, Alquist, Dutton, Lieu, Price,
Steinberg
ASSEMBLY FLOOR : 62-13, 5/30/12 - See last page for vote
SUBJECT : Newborn screening program: critical congenital
heart
disease
SOURCE : American Heart Association
March of Dimes Foundation
DIGEST : This bill, beginning July 1, 2013, requires a
general acute care hospital that has a licensed perinatal
service to offer to parents of a newborn, prior to
discharge, a pulse oximetry test for the identification of
critical congenital heart disease (CCHD), using protocols
approved by the Department of Health Care Services (DHCS),
as specified; and requires these hospitals to develop a
CONTINUED
AB 1731
Page
2
CCHD screening program, as prescribed.
Senate Floor Amendments of 8/24/12 clarify the duties of
the DHCS under this bill.
ANALYSIS :
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 Department of Public Health (DPH) to
develop a genetic disease testing program. Requires DPH
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 DPH to provide genetic screening and
follow-up services. Allows DPH to provide laboratory
testing facilities or work with qualified outside labs
to conduct testing.
3. Requires DPH 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 insurance coverage.
4. Establishes the Newborn Hearing Screening Program (NHSP)
under the Children's Medical Services (CMS) Branch
CONTINUED
AB 1731
Page
3
within 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 hospitals to offer pulse oximetry screening for
critical congenital heart defects.
2. Requires DHCS to specify protocols for testing, based on
Centers for Disease Control and Prevention protocols.
3. Requires DHCS to begin phasing in the requirement by
July 1, 2013, with full participation by 2016.
4. Requires hospitals to be responsible for screening,
referral for appropriate care, and reporting data to
DHCS.
5. Specifies which health care personnel can perform the
test.
6. Will not require a newborn to be screened if the test
violates the parents' beliefs.
7. Authorizes the DHCS to designate responsibilities to
DPH.
8. Clarifies that DHCS is required to issue guidance
stating that hospitals are to perform the CCHD test in a
manner consistent with CDC guidelines for CCHD
screening.
Background
CHD . According to the Health and Human Services
Secretary's Advisory Committee on Heritable Disorders in
Newborns and Children (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
CONTINUED
AB 1731
Page
4
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% of all infant deaths and more
than 40% 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 seven specific
defects that are typically classified as CCHDs, which
represent about 17-31% of all CHDs. In the United States,
about 4,800 (or 11.6 per 10,000) babies born every year
have one of these seven CCHDs.
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.
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 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
CONTINUED
AB 1731
Page
5
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 DPH.
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.
Uniform screening panel . In 2010, U.S. Department of
Health and Human Services (HHS) Secretary 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 including
determining the impacts to state health departments to
CONTINUED
AB 1731
Page
6
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.
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 DPH Director. While
California typically waits for the official acceptance of
the disease by the HHS Secretary, DPH may also evaluate
additional disorders for addition into the NBS program
using specified criteria. Currently, California screens
for over 70 conditions.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
According to the Senate Appropriations Committee:
One-time costs up to $150,000 (50% General Fund, 50%
federal funds) to DHCS to develop protocols for
screening.
Increased costs to state health coverage programs
(including Medi-Cal, CalPERS, and other programs) to pay
for screening, between $600,000 and $1.8 million per year
(various funds), depending on the current level of
screening and the cost to conduct the screening.
Potential cost savings to Medi-Cal and other state health
programs, due to earlier diagnosis and intervention for
newborns with critical congenital heart defects. For
newborns diagnosed under the bill as well as those
newborns who would be diagnosed late without screening,
state health programs would incur substantial treatment
costs. However, when a newborn is diagnosed late, there
can be substantial costs to stabilize the newborn before
surgery can be attempted. While it is not possible to
say definitively that total costs will be less with
screening under the bill, that appears likely.
CONTINUED
AB 1731
Page
7
SUPPORT : (Verified 8/27/12)
American Heart Association (co-source)
March of Dimes Foundation (co-source)
American College of Cardiology, California Chapter
American College of Obstetricians and Gynecologists,
District IX California
Association of Regional Center Agencies
California Medical Association
Cisco Systems
Kaiser Permanente (if amended)
MCAH Action
Mended Little Hearts
Santa Clara County Board of Supervisors
The Arc and United Cerebral Palsy in California
OPPOSITION : (Verified 8/27/12)
California Association of Health Underwriters
California Hospital Association
ARGUMENTS IN 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 six babies with CCHD, three
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.
ARGUMENTS IN OPPOSITION : The California Hospital
Association writes:
The Centers for Disease Control (CDC) have estimated
pulse oximetry screening to cost up to $10.00 per infant.
CONTINUED
AB 1731
Page
8
These costs include screening equipment, supplies
associated with screening (e.g., probes, adhesive wraps),
and staff time needed to perform screening.
In California, there are approximately 500,000 infants
born annually. Using the CDC cost estimates this brings
the costs to California hospitals to administer this one
test to $5,000,000.
This does not include costs each hospital will incur in
their protocol development, staff training, maintenance
and reporting of data, and the physician and
family-parent education also required by this bill.
Costs associated with diagnosis and follow-up of infants
with out-of-range (positive) results are also not
included. For example, an echocardiogram to verify an
out-of-range (positive) screen could cost several hundred
dollars.
ASSEMBLY FLOOR : 62-13, 5/30/12
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Beall,
Bill Berryhill, Block, Blumenfield, Bonilla, Bradford,
Brownley, Buchanan, Butler, Charles Calderon, Campos,
Carter, Cedillo, Chesbro, Conway, Davis, Dickinson, Eng,
Feuer, Fong, Fuentes, Furutani, Galgiani, Gatto, Gordon,
Gorell, Hagman, Halderman, Hall, Hayashi, Roger
Hernández, Hill, Huber, Hueso, Huffman, Lara, Bonnie
Lowenthal, Ma, Mendoza, Miller, Mitchell, Monning,
Nestande, Olsen, Pan, Perea, V. Manuel Pérez, Portantino,
Skinner, Smyth, Solorio, Swanson, Torres, Wieckowski,
Williams, Yamada, John A. Pérez
NOES: Donnelly, Beth Gaines, Garrick, Grove, Harkey,
Jeffries, Jones, Logue, Mansoor, Morrell, Nielsen, Norby,
Wagner
NO VOTE RECORDED: Cook, Fletcher, Knight, Silva, Valadao
CTW:m 8/27/12 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
**** END ****
CONTINUED
AB 1731
Page
9
CONTINUED