STAFF ANALYSIS OF ASSEMBLY BILL 395 (Pan)Page 1
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 395A
AUTHOR: PanB
AMENDED: May 27, 2011
HEARING DATE: July 6, 20113
CONSULTANT:9
Trueworthy5
SUBJECT
Newborn screening program
SUMMARY
Requires the California Department of Public Health (DPH) to expand statewide screening of newborns to include screening for severe combined immunodeficiency (SCID) and other T-cell lymphopenias detectable as a result of SCID.
CHANGES TO EXISTING LAW
Existing law:
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 program, unless otherwise provided.
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 thedetection of certain hereditary and congenital diseases.
Requires DPH to charge a fee for newborn screening and follow-up services, and requires the amount of the fee to be established pursuant to regulation and periodically adjusted.
Requires that any fee charged for screening and follow-up services provided to Medi-Cal eligible persons, health careservice plan enrollees, or persons covered by disabilityinsurance policies are to be paid directly to the Genetic Disease Testing Fund, and are subject to the terms and conditions of the health care service plan or insurance coverage.
This bill:
Requires DPH to expand statewide screening of newborns to include screening for severe SCID and other T-cell lymphopenias detectable as a result of SCID.
FISCAL IMPACT
According to the Assembly Appropriations committee analysis, AB 395 has the following potential costs:
- Annual estimated screening costs to the DPH Newborn Screening(NBS) Program statewide of $5 million (special fund).
- Annual estimated screening costs to the Medi-Cal program of $2.2 million (50 percent General Fund (GF)). Medi-Cal pays for approximately 45 percent of the births in the state, and reimburses the NBS program for screening costs associated with Medi-Cal births.
- Annual treatment costs to the Medi-Cal program for babies diagnosed with SCID are estimated to be in the range of $250,000 annually (50 percent GF).
- Annual treatment cost savings to the Medi-Cal program from early detection of SCID, potentially in the range of $1-2 million annually (50 percent GF). In the absence of early detection, treatment costs for newborns in the Medi-Cal program with SCID annually are highly variable and can be significant, depending on the time of diagnosis, whether they are diagnosed before succumbing to lethal opportunistic infections, and whether and when treatment is attempted.
BACKGROUND AND DISCUSSION
According to the author, AB 395 expands the California NBS Program to adopt SCID as the 30th “core” disorder screened for in the program. The author argues that this bill is needed to implement the recommendations of the federal Health and Human Services (HHS) Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) and bring the NBS Program into alignment with the most up-to-date research, technology, laboratory, and public health standards and practices. The author states that SCID is the most serious primary immunodeficiency disorder and leads to extreme susceptibility to serious illness. The author argues that unless these defects are corrected early on in the child’s life the child will die of opportunistic infections before their first or second birthday.
SCID
The defining characteristic of SCID is the absence of T-cells and, as a result, the lack of B-cell functions. B-cells are specialized white blood cells made in the bone marrow that fight infection. These genetic defects lead to extreme susceptibility to serious illness. Unless these defects are corrected,children are vulnerable to opportunistic infections and will likely die before their first or second birthday. In the past, children with this disorder were kept in strict isolation, sometime in a plastic isolator or “bubble.” Now treatments are available to significantly enhance the health outcomes of infants with SCID who are presyptomatic or early symptomatic.
Based on national studies, stem cells from either umbilical cord blood or bone marrow appears to be effective in significantly decreasing the morbidity and mortality for children with a type of SCID caused by a mutated gene on the X chromosome. According to the genetic disease screening program, if the treatment is provided within 3.5 months of life, the long-term survival rate is 95 percentand after 3.5 months it is 60 to 70 percent. When left untreated, children rarely survive past the age of two.
Pilot project
Beginning in August of 2010, DPH has been participating in a pilot project to test for SCID sponsored by the Jeffrey Modell Foundation and the National Institutesof Health. According to the March of Dimes, all babies born in California since the pilot began have been screened. Out of 235,686 babies screened, seven have been identified as SCID babies. The pilot has also lead to the identification of four other babies with T-cell lymphopenia. Current data as a result of the pilot has shown the rate of SCID to be 1 in 35,000 in California while it was previously estimated to be 1 in 100,000.
Methodology for adding new conditions
According to DPH, there is no national standard process to add a disorder to a state’s screening program. Some states will add a disorder once it is recommended by SACHDNCbut prior to official acceptance by the HHS Secretary, while other states wait for the official acceptance by the HHS Secretary. In California disorders have been added through the budget process or through legislation directing the department to add a specific disorder to the screening program.
In May 2010, Secretary Sebelius of the HHS adopted the SACHDNC recommendation of the Uniform Screening Panel to adopt the recommendation to add SCID as a core condition and the related T-cell lymphocyte deficiencies to the list of secondary targets.
Prior legislation
SB 142 (Alpert), Chapter 687, Statutes of 2004,extends the date by which DPH would be required to obtain screening from laboratories by competitive bid from July 1, 2005 to August 1, 2005.
SB 1103 (Senate Budget and Fiscal Review), Chapter 228, Statutes of 2004, expands statewide screening of newborns to include mass spectrometry screening (TMS)screening for fatty acid oxidation, amino acid, organic acid disorders, and congenital adrenal hyperplasia and provides that if DPH is unable to provide this screening by July 1, 2005, requires screening for these disorders to be obtained from one or more laboratories. Provides specified flexibility to amend contracts for implementation of the TMS screening.
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 makes an outreach and community awareness process for this program voluntary, versus mandatory.
AB 2427 (Kuehl), Chapter 803, Statutes of 2000,makes various changes to existing law relating to the genetic disease testing program, as specified, and stateslegislative intent that unless otherwise specified, the program carried out is to be fully supported from fees collected for services provided by the program.
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 phenylketonuria (PKU), a genetic disorder.
SB 537 (Greene), Chapter 1011, Statutes of 1998,requires DPH to establish a program to provide extended newborn genetic screening services for persons who elect to have, and pay for, the additional screening, and would require the department to charge a fee not to exceed the costs of these additional screenings, that would be deposited into the Genetic Disease Testing Fund.
Arguments in support
The March of Dimes, the sponsor of the bill, writes that, any disease affecting newborns that can be detected and treated should be, and it is critical that SCID be added to the California NBS Program. The March of Dimes argues that the health benefits of screening newborns for SCID are apparent, but screening would also likely lead to economic relief in California as well. The Children’s Advocacy Institute writes that AB 395 would make possible the identification of SCID shortly after birth, allowing for timely, cost-effective treatment and could save the lives of children who are born with this condition.
The American Academy of Pediatrics writes that early screening for SCID is critically important as data shows that SCID infants who receive a related donor bone marrow transplant within the first 14 weeks of life are significantly more likely to survive and have fewer problems overtime than those who receive transplants later in infancy or who have already developed an infection.
PRIOR ACTIONS
Assembly Health:15- 1
Assembly Appropriations:12- 5
Assembly Floor:71- 4
POSITIONS
Support:March of Dimes (sponsor)
American Academy of Pediatrics, California
California Medical Association
Children’s Advocacy Institute
Talecris Biotherapeutics
The American College of Obstetricians and Gynecologists, California
Oppose: None on file.
-- END --