BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 1095
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|AUTHOR: |Pan |
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|VERSION: |February 17, 2016 |
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|HEARING DATE: |April 13, 2016 | | |
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|CONSULTANT: |Reyes Diaz |
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SUBJECT : Newborn screening program
SUMMARY : Requires the Department of Public Health to expand statewide
screening of newborns to include screening for any disease as
soon as the disease is adopted by the federal Recommended
Uniform Screening Panel.
Existing law:
1)Requires the Department of Public Health (DPH) to establish a
genetic disease unit to coordinate all DPH programs in the
area of genetic disease that will promote a statewide program
of information, testing, and counseling services and to have
the responsibility of designating tests and regulations to be
used in executing this program and to have the responsibility
of designating tests and regulations to be used in executing
the California Newborn Screening Program (CNSP).
2)Requires DPH to charge a fee for newborn screening and
follow-up services, and requires the amount of the fee to be
periodically adjusted in order to meet the costs of the CNSP.
3)Requires DPH to expand statewide screening of newborns to
include screening for adrenoleukodystrophy (ALD) as soon as
ALD is adopted by the federal Recommended Uniform Screening
Panel (RUSP).
This bill: Requires DPH to expand statewide screening of
newborns to include screening for any disease as soon as the
disease is adopted by the RUSP.
FISCAL
EFFECT : This bill has not been analyzed by a fiscal committee.
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COMMENTS :
1)Author's statement. According to the author, newborn screening
for rare diseases is a critical, cost-effective public health
intervention, as diagnosing diseases at birth leads to earlier
medical intervention. In turn, early treatment saves and
improves children's and families' lives and reduces medical
costs by eliminating or ameliorating the devastating
consequences of rare and treatable diseases. California's
current approach to reviewing and approving screening for
additional diseases has created a lag behind current medical
recommendations. A study in the journal Pediatrics found that
California saves $9.32 in health care costs for every dollar
spent on newborn screening.
2)Background. According to DPH, California, like most states,
follows recommendations from the federal Health and Human
Services' (HHS) Discretionary Advisory Committee on Heritable
Disorders in Newborns and Children (DACHDNC) and waits for the
final approval from the HHS Secretary before requiring a new
screening. Because disorders are not officially part of the
RUSP until they are approved by the HHS Secretary, states do
not generally implement screenings before the final approval.
DPH's Director has the authority to add new disorders
administratively, such as in cases where there is a grave
public health need and the DACHDNC is not moving swiftly
enough to review and add the disorder to the RUSP. However,
according to DPH, since the creation of the RUSP and the
DACHDNC, this has never been the case. DPH also states that
since the creation of the RUSP, DPH relies on the
comprehensive expert investigations and recommendations the
DACHDNC makes to the HHS Secretary and the vetting process of
the RUSP to make additions to the state's newborn screening
panel. DPH is currently in the process of procuring equipment
and personnel to screen for ALD per AB 1559 (Pan, Chapter 565,
Statutes of 2014), which the HHS Secretary added to the RUSP
on February 16, 2016.
According to its Charter, the purpose of the DACHDNC is to
advise the HHS Secretary about aspects of newborn and
childhood screening and technical information, which includes
development of policies and priorities. The DACHDNC is
responsible for developing a model decision-matrix for newborn
screening expansion to evaluate the potential public health
impact of such expansion, including the cost of such
expansion; periodically updating the RUSP, as appropriate,
SB 1095 (Pan) Page 3 of ?
based on the decision-matrix; and considering ways to ensure
that all states attain the capacity to screen for the
conditions, including the results of grant funding. The
DACHDNC is also responsible for implementing, monitoring, and
evaluating newborn screening activities that include
diagnosis, screening, follow-up, treatment activities, and
technology used for screening.
3)CNSP. Since its creation in 1966, the CNSP has been expanded
several times as new discoveries are made and tests developed,
and now screens for more than 70 disorders. Diseases have been
continually added through regulation and legislation.
According to DPH's Web site, newborn screening is recognized
nationally as an essential preventive health measure. All
states in the nation and the District of Columbia have
established newborn screening programs. Disorders screened for
by the program have varying degrees of severity. If identified
early, many conditions can be treated before they cause
serious health problems. Prior to leaving the hospital, a few
drops of blood from the newborn's heel are collected on filter
paper. Parents can get the test results from the baby's doctor
or clinic, which take about two weeks. If the baby needs more
tests, parents will get a letter or a phone call a few days
after discharge from the hospital. Positive test results are
immediately telephoned to a follow-up coordinator at one of
the Newborn Screening Area Service Centers throughout the
state. The coordinator contacts the newborn's physician to
arrange for repeat testing. If repeat testing determines that
the baby has a disorder, the coordinator will supply the
latest clinical information on diagnosis and treatment and
assist with referrals to special care clinics. Currently, the
cost of the test is $111.70. Medi-Cal, health plans, and most
private insurance will pay for the test.
4)Related legislation. AB 170 (Gatto), would require DPH to
provide information about genetic testing and to obtain a
signed form, as specified, from a parent or guardian of a
newborn child regarding the collection of blood samples, as
specified; would allow parents and guardians, and individuals
at least 18 years of age, to request, as specified, that blood
samples not be used for medical research, or to be destroyed,
or both, as specified. AB 170 is pending in the Senate Health
Committee.
5)Prior legislation. AB 1559, requires DPH to add ALD for
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newborn screening as soon as ALD is adopted by the federal
RUSP.
SB 1334 (Walters, of 2014), would have required DPH, until
January 1, 2020, to expand the screening of newborns in Orange
County to include Krabbe disease. SB 1334 died without being
heard in the Senate Health Committee.
SB 224 (Walters, of 2013), would have required DPH, until
January 1, 2019, to expand the screening of newborns in Orange
County to include screening for Krabbe disease. SB 224 was
held in the Assembly Appropriations Committee.
SB 1072 (Strickland, of 2012), would have required DPH, until
January 1, 2018, to expand statewide screening of newborns to
include screening for Hurler syndrome and Krabbe disease. SB
1072 was held in the Senate Appropriations Committee.
SB 1731 (Block, Chapter 336, Statutes of 2012), established
the Newborn Critical Congenital Heart Disease (CCHD) Screening
Program and required hospitals, beginning July 1, 2013, to
offer a pulse oximetry test for the identification of CCHD to
parents of newborns prior to discharge.
AB 395 (Pan, Chapter 461, Statutes of 2011), expanded
statewide screening of newborns to include screening for
severe combined immunodeficiency.
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
adrenal hyperplasia.
AB 442 (Committee on Budget, Chapter 1161, Statutes of 2002),
required hospitals to collect fees associated with any tests
conducted under the CNSP.
SB 537 (Greene, Chapter 1011, Statutes of 1998), required DPH
to establish a program to provide extended newborn genetic
screening services for persons who elect to have, and pay for,
the additional screening.
6)Support. Supporters of this bill, largely patient
organizations and health providers, argue that millions of
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babies born in the U.S. are screened for a variety of diseases
and conditions that might otherwise go undetected and, if left
untreated, can cause disabilities, developmental delays,
illnesses, or even death. Supporters state that early
detection of these conditions can provide for early treatment
that can affect a child's long-term health or survival.
Supporters argue that instead of using the current system of
adding new diseases to the screening program though
legislation, this bill allows the state to conform to federal
recommendations, which would avoid unnecessary delays and
allow for comprehensive testing.
7)Letter of concern. The California Hospital Association (CHA)
states that while it strongly supports the newborn screening
program and the expansion of genetic testing for newborns, the
language of the bill does not limit the screening to the
current system. CHA states that this bill could require
hospitals to obtain expensive new equipment, hire personnel,
and/or undertake new and unusual procedures to test for any
future disease that RUSP designates. CHA believes that any
future testing that would require additional costs or
equipment should be considered by DPH and stakeholders about
whether and how best to screen for new diseases adopted by the
RUSP.
8)Opposition. California Right to Life, Inc. argues that this
bill does not correct the issue of the limited ability to opt
out of the screening program for religious beliefs or
practices and may even bring discrimination against parents or
guardians who do opt out.
9)Policy comment. The author of this bill argues that the
state's current process for adding new screenings has created
a lag behind current medical recommendations. However, DPH
states that since the creation of the RUSP and the DACHDNC,
DPH's Director has not had to exercise authority to add new
screenings to the CNSP before being added to the RUSP, which
is used when the DACHDNC is not acting swiftly enough.
Therefore, the effect of this bill is unclear.
SUPPORT AND OPPOSITION :
Support: EveryLife Foundation for Rare Diseases (sponsor)
Acid Maltase Deficiency Association (AMDA)
Aidan Jack Seeger Foundation
ALD Connect, Inc.
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American Academy of Pediatrics
American Behcet's Disease Association
American Federation of State, County and Municipal
Employees, AFL-CIO
Amour Fund - Alpha Epsilon Omega Foundation
Angels for Life Foundation
Batten Disease Support & Research Association
Brian's Hope
Bridge the Gap - SYNGAP Education and Research
Foundation
California Academy of Physicians Assistants
California Primary Care Association
Children's PKU Network
Chronic Granulomatous Disease Association
Coalition Duchenne
County Health Executives Association of California
Cure Sanfilippo Foundation
DiMedio Foundation for Children
Drew'sHope Research Foundation
Engage Health, Inc.
Fabry Support & Information Group
Friedreich's Ataxia Research Alliance
Gene Giraffe Project
Gene Spotlight, Inc.
Global Genes
Grace Science Foundation
Hannah's Hope Fund
Hope4Bridget
Hunter Syndrome Foundation
Immune Deficiency Foundation
International Pemphigus & Pemphigoid Foundation
International Society for Mannosidosis and Related
Diseases
International Waldenstrom's Macroglobulinemia
Foundation
Jeffrey Modell Foundation
Jett Foundation
Jonah's Just Begun Foundation to Cure Sanfillipio
LAL Solace, Inc.
Leukemia Lymphoma Society
Little Miss Hannah Foundation
Lung Transplant Foundation
Lupus and Allied Diseases Association
Lymphatic Malformation Institute
Lysosomal Disease Network
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March of Dimes
MPS 6CESS Foundation
National Leiomyosarcoma Foundation
National Lymphedema Network
National PKU Alliance
National Tay-Sachs & Allied Diseases Association
Nicholas Conor Institute
Noah's Hope
NTM Info & Research, Inc.
Olivia's Heart Project
Organic Acidemia Association
Oxalosis and Hyperoxaluria Foundation
Parent Project Muscular Dystrophy
Pediatric Hydrocephalus Foundation
Phoenix Fox Foundation
Pulmonary Fibrosis Advocates
Rare & Undiagnosed Network
Rare Disease United Foundation
Reflex Sympathetic Dystrophy Syndrome Association
Sanfilippo Foundation for Children
Save Babies Through Screening Foundation
Saving Case & Friends, a Hunter Syndrome research &
advocacy foundation
Stop ALD Foundation
Taylor's Tale
Team Niemann-Pick Type C
The Mastocystosis Society
The MLD Foundation
The Myelin Project
The National MPS Society
The Orphan Disease Pathway Project
The OsteoPETrosis Society
The RASopathies Network
The Ryan Foundation
The XLH Network, Inc.
United Leukodystrophy Foundation
Vanishing White Matter Disease
Wired4Life
Zeqing for a Cure
Oppose: California Right to Life, Inc.
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