BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  AB 395
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          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 








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            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 








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          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.  








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          Analysis Prepared by  :    Marjorie Swartz / HEALTH / (916) 
          319-2097 

                                                                FN: 0001055