BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 1095|
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UNFINISHED BUSINESS
Bill No: SB 1095
Author: Pan (D), et al.
Amended: 8/15/16
Vote: 21
SENATE HEALTH COMMITTEE: 9-0, 4/13/16
AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,
Pan, Roth, Wolk
SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/27/16
AYES: Lara, Bates, Beall, Hill, McGuire, Mendoza, Nielsen
SENATE FLOOR: 39-0, 6/2/16
AYES: Allen, Anderson, Bates, Beall, Berryhill, Block,
Cannella, De León, Fuller, Gaines, Galgiani, Glazer, Hall,
Hancock, Hernandez, Hertzberg, Hill, Hueso, Huff, Jackson,
Lara, Leno, Leyva, Liu, McGuire, Mendoza, Mitchell, Monning,
Moorlach, Morrell, Nguyen, Nielsen, Pan, Pavley, Roth, Stone,
Vidak, Wieckowski, Wolk
NO VOTE RECORDED: Runner
ASSEMBLY FLOOR: 78-0, 8/18/16 - See last page for vote
SUBJECT: Newborn screening program
SOURCE: EveryLife Foundation for Rare Diseases
DIGEST: This bill requires the Department of Public Health to
expand statewide screening of newborns to include screening for
any disease, as specified.
Assembly Amendments (1) require expansion of statewide screening
of newborns to occur no later than two years after a new disease
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is adopted by the federal program, as specified, or enactment of
this bill, whichever is later; and (2) add coauthors.
ANALYSIS:
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 that is detectable in blood
samples as soon as practicable, but no later than two years
after the disease is adopted by the RUSP or enactment of this
bill, whichever is later.
Comments
1)Author's statement. According to the author, newborn screening
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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
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screening expansion to evaluate the potential public health
impact of such expansion, including the cost of such
expansion; periodically updating the RUSP, as appropriate,
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.
FISCAL EFFECT: Appropriation: Yes Fiscal
Com.:YesLocal: No
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According to the Assembly Appropriations Committee:
1)One-time costs of $2.4 million and ongoing costs of $4.3
million per year to screen for two diseases (MPS-1 and Pompe
disease) that have already been approved for inclusion in the
RUSP (Genetic Disease Testing Fund). The ongoing costs would
cover initial screening tests, follow-up tests for positive
results, and initial case management for confirmed diagnoses.
The Genetic Disease Screening Program is fee-supported; most
health insurance, including Medi-Cal, cover the screening fee.
The fee has increased pursuant to the 2016-17 Budget Act, and
is currently $130.25. Adding these two conditions would
require an additional fee increase of about $9.
2)Ongoing costs of over $2 million per year for coverage of the
increased screening fee by the Medi-Cal program (GF/federal).
Medi-Cal covers the cost of the screening exam and Medi-Cal
pays for roughly 50% of the births in the state.
3)Unknown future costs to expand newborn screening program to
add screening tests for new diseases as they are adopted as
part of the RUSP (Genetic Disease Testing Fund). Costs vary by
disease; recent additions have generally cost in the low
millions per condition, per year. Screening fees will be
adjusted to support the additional projected expenditures.
4)Potential long-term savings due to improved clinical outcomes
from early testing and treatment (various funds). When
considering whether to include additional diseases in the
RUSP, a federal advisory committee considers issues such as
the reliability of the screening test, the availability of
treatments, the benefits of early diagnosis, and the
anticipated impact on health outcomes from additional
screening. Specific information about the long-term impacts on
health outcomes or avoided health care costs are often not
available because the diseases that are considered for
inclusion are rare and treatments are evolving rapidly.
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However, new diseases are added when the advisory panel finds
that there are benefits from screening, primarily the ability
to avoid long-term health consequences with early
intervention. Although it is not certain whether additional
screening and treatment is actually cost-saving when
considering the screening costs, it is reasonable to project
that early diagnosis made possible by screening for new
diseases will reduce health care costs in specific cases.
SUPPORT: (Verified8/18/16)
EveryLife Foundation for Rare Diseases (source)
Acid Maltase Deficiency Association
Aidan Jack Seeger Foundation
ALD Connect, Inc.
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.
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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
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
Stop ALD Foundation
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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
OPPOSITION: (Verified8/18/16)
California Right to Life, Inc.
ARGUMENTS IN SUPPORT: Supporters of this bill, largely
patient organizations and health providers, argue that millions
of 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.
ARGUMENTS IN 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
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beliefs or practices and may even bring discrimination against
parents or guardians who do opt out.
ASSEMBLY FLOOR: 78-0, 8/18/16
AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker,
Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke,
Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley,
Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth
Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto,
Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper,
Holden, Irwin, Jones, Jones-Sawyer, Lackey, Levine, Linder,
Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina,
Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen,
Patterson, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago,
Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber,
Wilk, Williams, Wood, Rendon
NO VOTE RECORDED: Roger Hernández, Kim
Prepared by:Reyes Diaz / HEALTH / (916) 651-4111
8/19/16 19:29:33
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