BILL ANALYSIS �
AB 1731
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Date of Hearing: April 17, 2012
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 1731 (Block) - As Amended: April 9, 2012
SUBJECT : Newborn screening program: critical congenital heart
disease.
SUMMARY : Establishes the Newborn Critical Congenital Heart
Disease (CCHD) Screening Program and requires hospitals to offer
a pulse oximetry test for the identification of CCHD to parents
of newborns prior to discharge. Specifically, this bill :
1)Applies the requirement to general acute care hospitals with
licensed perinatal services.
2)Requires the hospital to use protocols approved by the
Department of Health Care Services (DHCS).
3)Requires DHCS to begin phasing in implementation by hospitals
on or after July 1, 2013 and requires 100% participation rate
by 2016.
4)Requires hospitals to develop a screening program with the
following elements:
a) Competent CCHD screening;
b) Appropriate staff and equipment;
c) Referral of infants with abnormal screening results for
appropriate care;
d) Reporting and maintenance of data as required; and,
e) Physician and family-parent education.
5)Requires the pulse oximetry test to be performed by a licensed
physician, licensed registered nurse, or an appropriately
trained individual who is supervised by a licensed health care
professional.
6)Exempts a newborn if the parent or guardian objects on the
grounds that the test is in violation of his or her beliefs.
7)Makes legislative findings and declarations regarding the
incidence of CCHD, current methods of detection, and pulse
oximetry.
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EXISTING LAW :
1)Establishes the Newborn and Infant Hearing Screening,
Tracking, and Intervention Act which requires every general
acute care hospital with licensed perinatal services to offer
every newborn a hearing screening test for the identification
of hearing loss, as specified, and provide written information
on the availability of community resources and services for
children with hearing loss to the parents of those who are
diagnosed with a hearing loss.
2)Requires the Department of Public Health (DPH) to establish a
genetic disease unit to coordinate programs in the area of
genetic disease and promote a statewide program of
information, testing, and counseling services and to have the
responsibility of designating test and regulations to be used
in executing this Newborn Screening (NBS) Program. Under the
Hereditary Disorders Act, declares the intent of the
Legislature that the state's hereditary disorders program
activities are to be fully supported by fees collected for
services provided by the NBS Program, unless otherwise
provided.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . Congenital heart disease (CHD) involves
defects of the walls, valves, arteries, or veins of the heart
and occurs in seven to nine of every 1,000 live births in the
United States. According to the author, this bill is designed
to ensure that newborns are screened for CCHD, which is a
subset of CHD. This bill accomplishes this purpose by
requiring DHCS to establish statewide screening of newborns by
means of pulse oximetry screening. The author explains that
pulse oximetry screening is a test that occurs at the bedside
and is a non-invasive test that estimates the percentage of
hemoglobin in the blood that is saturated with oxygen. The
author argues that many newborn lives could potentially be
saved by earlier detection and treatment of CCHD if hospitals
were required to perform this simple, noninvasive screening
method.
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2)BACKGROUND . CHD is an overarching term that describes
clinical outcomes derived from a number of defects of the
walls, valves, arteries, or veins of the heart. The disease
is classified as critical or CCHD when it includes a group of
seven defects that cause severe and life-threatening symptoms
and requires intervention within the first days or first year
of life. According to the Centers for Disease Control and
Prevention (CDC), the incidence of CCHD in the United States
is about 11.6 per 10,000 babies per year. Other heart defects
can be just as severe, according to the CDC, and also require
treatment soon after birth, however pulse oximetry may not
detect these as consistently as those listed as CCHDs. Some
babies born with a heart defect can appear healthy at first
and may be sent home before the defect is detected. The CDC
advises that pulse oximetry newborn screening, along with the
physical examination, can identify some infants with a CCHD
before they show signs of the condition. Once identified,
babies with a CCHD can be seen by cardiologists and receive
special care and treatment to prevent death or disability.
According to the CDC, certain hospitals routinely screen all
newborns using pulse oximetry screening. However, currently
it is not included in most state newborn screening panels.
3)NEWBORN SCREENING. The Secretary of the federal Department of
Health and Human Services (DHHS) Advisory Committee on
Heritable Disorders in Newborns and Children (SACHDNC) was
chartered in February 2003 and is charged with making
systematic evidence-based and peer-reviewed recommendations to
advise the DHHS Secretary regarding the most appropriate
application of universal newborn screening tests,
technologies, policies, guidelines and standards for
effectively reducing morbidity and mortality in newborns and
children having, or at risk for, heritable disorders. In
2010, the Secretary adopted the SACHDNC's Recommended Uniform
Screening Panel (RUSP) as a national standard for newborn
screening programs and to facilitate the adoption of the
SACHDNC's RUSP by all state newborn screening programs. The
RUSP included 29 core conditions and 25 secondary conditions
which are disorders that can be detected in the differential
diagnosis of a core disorder. At the same time, the Secretary
adopted the recommendation to add Severe combined
immunodeficiency (SCID) as a core condition and related T-cell
lymphocycte deficiencies as a secondary condition to the RUSP.
California is in the process of adding the SCID screening as
directed by AB 695 (Pan), Chapter 461, Statutes of 2011, which
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will conform California's NBS to the Secretary's
recommendations.
4)CCHD PULSE OXIMETRY SCREENING . In April of 2011, the
Secretary notified SACHDNC that its recommendations pertaining
to the addition of CCHD screening to the RUSP were not yet
ready for adoption primarily due to a number of identified
evidence gaps. Since then a number of steps have been
undertaken by the Secretary, SACHDNC, and other national
public health agencies and advisory groups with regard to
these identified issues. On September 21, 2011, the Secretary
decided to adopt the SACHDNC recommendation to add CCHD to the
RUSP. In addition, she requested that SACHDNC collaborate
with the Health Resource and Services Administration (HRSA) to
complete a thorough evaluation of the potential public health
impact of universal screening for CCHD. One of the steps she
had previously taken was to refer the recommendations to the
Interagency Coordinating Committee on Screening in Newborns
and Children (ICC) for additional review and input on
implementation. She specifically requested the ICC to review
the evidence gaps and propose a plan of action. The Secretary
stated that the ICC Plan of Action and other reviewing
entities had identified remaining evidence gaps and she
concluded that these should receive closer attention as
implementation occurs. As a consequence, a comprehensive
Federal Plan of Action has been undertaken. This includes
research by the National Institute of Health to determine the
relationship of screening to outcomes of affected newborns and
CDC surveillance and monitoring of the link to infant
mortality and other health outcomes. HRSA will guide the
development of screening standards and infrastructure needed
for the implementation of a public health approach to point of
service screening for CCHD and is funding the development of,
in collaboration with public health and health care
professionals and families, appropriate education and training
materials for families and public health care professionals
relevant to the screening and treatment of CCHD.
5)SCREENING PROTOCOLS . This bill requires hospitals to use
protocols approved by DHCS. One of the identified evidence
gaps is the lack of standardized screening protocols.
Neonates with abnormal pulse oximetry screening results need
confirmatory testing for the cause and immediate intervention.
The Federal Plan of Action calls for HRSA to support the
development, dissemination, and validations of screening
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protocols and newborn screening infrastructure during 2011.
HRSA is also in the process of awarding grants for a
three-year demonstration program for this purpose. In
addition the Federal Plan includes future guidance to state
Medicaid directors for screening, follow-up and treatment that
is medically necessary for children enrolled in Medicaid.
6)SUPPORT . The March of Dimes writes that it supports this bill
because it will save lives. According to the March of Dimes,
CCHD is a subgroup of CHD that affects approximately 4,800
babies born in the United States each year. In support, the
March of Dimes states that a California study has shown that
an estimated 30 babies die each year in California from
undiagnosed CCHD, deaths that could be prevented if CCHD is
detected and treated earlier. Babies with CCHD have a heart
defect that requires intervention, such as surgery, in the
first few hours, days, or months of life. March of Dimes
points out that it has been instrumental in expanding newborn
screening and is supportive where there is a documented
medical benefit to early detection, a reliable screening test
and early detection can be done through specific means, all of
which exist for CCHD screening.
The American Heart Association (AHA) also in support of this
bill writes that some CCHD can cause severe and
life-threatening symptoms that require intervention within the
first days of life. In addition, AHA argues in support, the
economic costs related to CHD are high. AHA states that when
conducted on newborns at the time of delivery, pulse oximetry
screening significantly improves the effectiveness and
probability of detecting CCHD. AHA believes that by requiring
pulse oximetry screening for all newborn babies, lives will be
saved and the economic impact of CHD will be reduced.
The Santa Clara Board of Supervisors writes in support that
the Director of Neonatal Intensive Care (NICU) at the Santa
Clara Valley Medical Center, Dr. Balaji Govindaswami, is a
pioneer in this remarkable simple technique. According to
this support, while pulse oximeters are routinely used as a
screening tool, they are not typically used on newborns.
Because they are common in the NICU setting however, Dr.
Goindaswami has identified that their use on all newborns
could identify otherwise completely unnoticed heart problems.
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The American Congress of Obstetricians and Gynecologists
(ACOG), District IX writes in support that the Secretary of
the DHHS added screening for CCHD to the RUSP in September
2010. ACOG writes that there are now 31 core conditions and
California requires screening for the 30 other conditions.
ACOG points out that CCHD screening is done through a
non-invasive pulse oximetry test, in which a sleeve is placed
on the infant's foot to measure blood oxygen saturation,
similar to the fingertip device used to measure an adult's
blood oxygen and that detect CCHD before symptoms present
themselves, allowing for the proper treatment to be given to
prevent disability or death.
7)SUPPORT WITH AMENDMENTS . The Children's Specialty Care
Coalition (CSCC) writes that while they support the general
intent of this bill to institute newborn screening for CCHD,
they have concerns. Specifically, in order to ensure that
sick children receive appropriate and quality health care
services they recommend that this bill include reference to
the generally accepted screening protocols for CCHD that have
been endorsed by the American Academy of Pediatrics, AHA and
the SACHDNC's Expert Panels Workgroup's Preliminary
Recommendations. CSCC further states in support of these
amendments that pediatric cardiologists who have reviewed this
bill, support moving forward with state screening of newborn
for CCHD, but point out that it is essential to use generally
accepted screening protocols in order to minimize the number
of false positive results from the test. According to CSCC,
large numbers of false positive results would lead to greater
health care costs in the system because of the need for
echocardiograms and referrals to specialists that would be
necessary to confirm the diagnoses, unnecessary worry on the
part of the parents and family members, and finally a large
number of false positive results could overwhelm our network
of pediatric cardiologists in the state with unnecessary
referrals.
8)OPPOSITION . The California Hospital Association (CHA), in
opposition to the bill, writes that in California, there are
more than 500,000 babies born in hospitals each year.
According to CHA, for each of those births, hospitals
administer a hearing screening test for identification of
hearing loss, as well as genetic disease testing as required
by state law. These programs are administered and managed by
the DHCS and the DPH, respectively. CHA writes that while
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they appreciate the bill's intent to add testing for CCHD to
the growing list of services provided to newborns prior to
discharge from a hospital, they are mindful of the impact a
new mandate has on hospitals, health care professionals, and
our state's health oversight infrastructure and financing
capacity.
CHA argues that any new mandate for screening should be
evidence-based and only be implemented once standard protocols
have been tested and when it is established that actual
benefits, in terms of improved patient outcomes, will result.
According to their opposition, this bill fails to address many
necessary and critical components of a screening program. In
opposition, CHA raises the following issues:
a) No statewide uniformity of protocol - each hospital is
required to develop its own protocol and to submit it to
the state for approval. This is contrary to how similar
testing programs have been implemented in California.
b) Data collection - no mechanism is established to
collect, evaluate, and monitor data reported from hospitals
for quality improvement tracking purposes.
c) Reimbursement - hospitals will have to purchase
specialty pediatric equipment and supplies to perform this
test; incur labor costs to develop the protocol and
training material for their staff; inventory, sterilize,
store, and maintain the equipment; obtain consent and
document the consent; document the test outcomes; and,
educate physicians and family members, etc. The costs are
extensive. How will these costs be reimbursed?
d) RELATED LEGISLATION . SB 1072 (Strickland ) of 2012,
requires DPH to expand statewide screening of newborns to
include screening for the following types of lysosomal
storage diseases: Fabry disease, Gaucher disease, Hurler
syndrome, also known as mucopolysaccharidosis type I,
Krabbe disease, Niemann-Pick disease, and Pompe disease.
SB 1072 is pending in the Senate Health Committee.
9)PREVIOUS LEGISLATION .
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a) AB 2651 (Jones), Chapter 335, Statutes of 2006, requires
all licensed acute care hospitals with perinatal services
to administer newborn hearing screening tests effective
January 1, 2008.
b) SB 1103 (Committee on Budget and Fiscal Review), Chapter
228, Statutes of 2004, expands statewide screening of
newborns to include tandem mass spectrometry (TMS)
screening for fatty acid oxidation, amino acid, organic
acid disorders, and congenital adrenal hyperplasia and
provided that if DPH was unable to provide this screening
by July 1, 2005, requires screening for these disorders was
to be obtained from one or more laboratories.
c) AB 442 (Committee on Budget), Chapter 1161, Statutes of
2002, requires hospitals to collect fees associated with
any tests conducted under the State's NBS Program and made
an outreach and community awareness process for this
program voluntary, versus mandatory.
d) SB 148 (Alpert), Chapter 541, Statutes of 1999, requires
health care service plans and specified disability insurers
to provide coverage for the testing and treatment of PKU, a
genetic disorder.
e) 2780 (Gallegos, Ducheny, and Villaraigosa), Chapter 310,
Statutes of 1998, requires every California Children's
Services (CCS)-approved general acute care hospital with
licensed perinatal services in this state to offer all
parents of a newborn a hearing screening test, as
specified. Requires the Department of Health Services (now
DPH) to begin phasing in implementation of a comprehensive
hearing screening program by CCS-approved general acute
care hospitals with licensed perinatal services on or after
July 1, 1999, and 100% participation by December 31, 2002.
f) SB 537 (Greene), Chapter 1011, Statutes of 1998, creates
a trial program for the use of TMS to screen for treatable
genetic diseases under the NBS program funded by fees paid
voluntarily into the Genetic Disease Testing Fund by the
family.
10)POLICY COMMENT .
a) Implementation Challenge . The primary method of
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screening newborns for the other core conditions on the
RUSP is by means a needle stick in the infant's heel. In
California this is administered by the DPH NBS Program.
Prior to leaving the hospital, a few drops of blood from
the newborn's heel are collected on filter paper. Medi-Cal
and most private insurance will pay for the test. The
sample is sent to one of seven regional laboratories or to
a centralized laboratory at DPH for testing. The results
are sent to DPH for data collection and quality control.
Parents obtain the test results from the baby's doctor or
clinic. It takes about two weeks for the doctor to receive
the written results. If the baby needs more tests, parents
will get a letter or a phone call a few days after
discharge from the hospital.
Last session, testing for SCID was added to the NBS by AB 395
(Pan). Administratively, this addition was relatively
straightforward as it merely required an addition of a new
spot on the filter paper and did not require any new
protocols or equipment at the hospital. In addition, DPH
had been involved in a pilot study that ended in February
2012 to screen for SCID and found that it was far more
common than previously estimated. As part of the pilot
study, DPH also determined that because of the need for new
testing equipment, relying on the regional laboratories
would have required a significant fee increase. It was
therefore determined to be more cost-effective to
centralize the testing at the state laboratory. Because
NBS is fully fee supported, a fee increase of $9.95 is
required. Prior to this increase, the cost of the NBS test
was $102.75.
Unlike the blood test in the NBS program, this bill proposes
a test with medical equipment in the hospital and requires
immediate interpretation or analysis of the results. In
that regard, it is more analogous to the Newborn and Infant
Hearing Screening, Tracking, and Intervention Program which
is administered by DHCS. In California, infants who do not
pass the initial hearing screening in the hospital are
referred for a rescreening which could be performed before
one month of age. Infants who do not pass the rescreening
are referred for a diagnostic hearing evaluation. Upon
identification of hearing loss, infants and their families
are referred to the local Early Start Program, a
multi-agency effort by the Department of Developmental
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Services and the California Department of Education for
access to early intervention and related services.
Even though this bill proposes a screening program analogous
to the auditory screening program, implementation will
require a number of new hospital protocols, state mandated
activities, and follow-up. As Secretary Sibelius pointed
out in her letter adopting the SACHDNC recommendations, it
would be beneficial to states, health care facilities, and
individual clinicians to have the SACHDNC and other public
health experts, partner with HRSA to provide information
about a number of issues, including but not limited to the
following:
i) What will be the impact on state health departments,
including staffing needs, to implement this program?
ii) What are the roles for the state health departments?
iii) What capability is present to ensure that all babies
are screened and their results are communicated to
providers, including assuring that those not screened at
birth receive a screen?
As stated above, the various federal health and public
health agencies have been tasked with filling these
evidence gaps identified by the Secretary and others when
this recommendation was considered.
The author may wish to explain whether the timeline and
implementation strategy envisioned by this bill is
sufficiently consistent with the Federal Plan of Action in
order to have these questions answered and assure that
implementation is done appropriately.
b) Recommended Amendment-Screening Protocol .
Standardization of protocols has also been identified as an
evidence gap. The author may wish to clarify that the
protocols approved by DHCS are to be consistent with those
generally accepted by nationally recognized medical
professional associations, scientific experts, and national
health and public health agencies.
REGISTERED SUPPORT / OPPOSITION :
Support
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American Congress of Obstetricians and Gynecologists, District
IX
American Heart Association
Association of Regional Center Agencies
California Chapter of the American College of Cardiology
March of Dimes
MCAH Action
Santa Clara County Board of Supervisors
Opposition
California Hospital Association
Analysis Prepared by : Marjorie Swartz / HEALTH / (916)
319-2097