BILL ANALYSIS Ó AB 395 Page 1 ASSEMBLY THIRD READING AB 395 (Pan) As Amended May 27, 2011 Majority vote HEALTH 15-1 APPROPRIATIONS 12-5 ----------------------------------------------------------------- |Ayes:|Monning, Ammiano, Atkins, |Ayes:|Fuentes, Blumenfield, | | |Bonilla, Eng, Garrick, | |Bradford, Charles | | |Gordon, Hayashi, Roger | |Calderon, Campos, Davis, | | |Hernández, Bonnie | |Gatto, Hall, Hill, Lara, | | |Lowenthal, Nestande, Pan, | |Mitchell, Solorio | | |V. Manuel Pérez, Smyth, | | | | |Williams | | | | | | | | |-----+--------------------------+-----+--------------------------| |Nays:|Logue |Nays:|Harkey, Donnelly, | | | | |Nielsen, Norby, Wagner | | | | | | ----------------------------------------------------------------- SUMMARY : Adds a test for the detection of severe combined immune deficiency (SCID) to the Newborn Screening (NBS) Program. Specifically, this bill : 1)Requires the Department of Public Health (DPH) to expand statewide screening of newborns to include screening for SCID as soon as possible. 2)Adds this expansion to existing exemptions for information technology contracts. 3)Requires the implementation of SCID screening to include screening for other with T-cell lymphopenias as long as it can be accomplished without additional costs or resources. 4)Deletes obsolete requirements for a report to the Legislature that was due on July 1, 2006, with regard to the progress of statewide screening for metabolic disorders. FISCAL EFFECT : According to the Assembly Appropriations Committee: 1)Annual estimated screening costs to the DPH NBS Program AB 395 Page 2 statewide of $5 million (special fund). This test is estimated to cost $9.50 per child. 2)Annual estimated screening costs to the Medi-Cal Program of $2.2 million Ý50% General Fund (GF)]. Medi-Cal pays for approximately 45% of the births in the state, and reimburses the NBS Program for screening cost associated with Medi-Cal births. In addition, 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% GF). 3)Annual treatment cost savings to the Medi-Cal Program from early detection of SCID, potentially in the range of $1-2 million annually (50% GF). In the absence of early detection, treatment costs for the handful of newborns in the Medi-Cal Program with SCID annually are highly variable and can be significant. There are documented cases where treatment costs for a single infant diagnosed with SCID after three and a half months exceeded $1 million COMMENTS : According to the author, the purpose of this bill is to add SCID to the NBS Program, making it the 30th disease that is screened. The author argues this bill is needed to implement the recommendations of the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) and brings the NBS Program into alignment with the most up-to-date research, technology, laboratory, and public health standards and practices Prior to leaving the hospital, a few drops of blood from the newborn's heel are collected on filter paper. Currently, the cost of the test is $102.75. Medi-Cal and most private insurance will pay for the test. The sample is sent to one of eight regional laboratories that contract with the DPH for testing. 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. According to DPH, 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 AB 395 Page 3 information on diagnosis and treatment and assist with referrals to special care. Disorders screened for by the NBS Program have varying degrees of severity. If identified early many of these conditions can be treated before they cause serious health problems. Treatments may include medication, dietary supplements, avoidance of fasting and/or special diet and comprehensive care to reduce morbidity and mortality. Infants with severe T-cell lymphopenia, including SCID, often appear normal at birth and have no family history of immunodeficiency. According to the March of Dimes, SCID is the most serious primary immunodeficiency disorder. The defining characteristic is the absence of T-cells and, as a result, lack of B-cell function, the specialized white blood cells made in the bone marrow to fight infection. These genetic defects lead to extreme susceptibility to serious illness. Unless these defects are corrected the child will die of opportunistic infections 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 several national studies, stem cell 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%, after 3.5 months it is 60%-70%. For those with adenosine deaminase deficiency, which affects males and females, enzyme replacement therapy may be an alternative treatment. In May 2010, Secretary Sibelius of the federal Health and Human Services adopted the SACHDNC recommendation of a Uniform Screening Panel which was to screen for the identified 29 core conditions and report on the identified 25 secondary conditions as a national standard and also adopted the recommendation to add SCID as a core condition and the related T-cell lymphocyte deficiencies to the list of secondary targets which updated the Recommended Uniform Screening Panel to 30 core conditions and reporting on 26 secondary conditions. AB 395 Page 4 Analysis Prepared by : Marjorie Swartz / HEALTH / (916) 319-2097 FN: 0001055