BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                            



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                                    THIRD READING


          Bill No:  AB 1559
          Author:   Pan (D), et al.
          Amended:  8/21/14 in Senate
          Vote:     21

           
           SENATE HEALTH COMMITTEE  :  8-0, 6/18/14
          AYES:  Hernandez, Morrell, Beall, DeSaulnier, Evans, Monning,  
            Nielsen, Wolk
          NO VOTE RECORDED:  De León

           SENATE APPROPRIATIONS COMMITTEE  :  5-0, 8/14/14
          AYES:  De León, Hill, Lara, Padilla, Steinberg
          NO VOTE RECORDED:  Walters, Gaines

           ASSEMBLY FLOOR  :  79-0, 5/28/14 - See last page for vote


           SUBJECT  :    Newborn screening program

           SOURCE  :     The Myelin Project


           DIGEST  :    This bill requires the Department of Public Health  
          (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).

           Senate Floor Amendments  of 8/21/14 eliminate the sunset date and  
          specify that DPH is required to expand statewide screening for  
          ALD as soon as ALD is adopted by the RUSP instead of "as soon as  
          possible."
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           ANALYSIS  :    Existing law:

          1.Requires DPH to establish a genetic disease unit to coordinate  
            all DPH programs in the area of genetic disease that promotes  
            a statewide program of information, testing, and counseling  
            services, and designates tests and regulations to be used in  
            executing this program, and designates tests and regulations  
            used in executing the California Newborn Screening Program  
            (CNSP). 

          2.Requires DPH to provide genetic screening and follow-up  
            services. Allows DPH to provide laboratory (lab) testing  
            facilities or work with qualified outside labs to conduct  
            testing.

          3.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 CNSP.

          4.Requires DPH to evaluate and prepare recommendations on the  
            implementation of tests for the detection of hereditary and  
            congenital diseases, including, but not limited to,  
            biotinidase deficiency and cystic fibrosis.  Requires DPH to  
            also evaluate and prepare recommendations on the availability  
            and effectiveness of preventative follow-up interventions,  
            including the use of specialized medically necessary dietary  
            products.  

          5.Requires statewide screening of newborns to include tandem  
            mass spectrometry screening for fatty acid oxidation, amino  
            acid, and organic acid disorders and congenital adrenal  
            hyperplasia. Also requires screening of newborns to include  
            screening for severe combined immunodeficiency, as soon as  
            possible.

          This bill requires DPH to add screening for ALD to the CNSP as  
          soon as ALD is adopted by the RUSP.

           Background
           
           Adrenoleukodystrophy  .  ALD can cause injury to the brain,  
          nerves, and adrenal glands.  The first signs of ALD are  
          behavioral and rapidly lead to a vegetative state and ultimately  

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          death.  The childhood form is the most severe and affects boys  
          between the ages of four and eight years old.  The slightly  
          milder adult version affects men in their 20s and 30s. Unless  
          treated before symptoms show, children affected with ALD will  
          die within a few months to a few years.  Early detection and  
          treatment provides dramatically better quality of life for the  
          affected individuals and their families.  Cord blood and bone  
          marrow transplants performed at a very early stage in the  
          disease have proven to treat and heal the patient, enabling a  
          healthy and long life.  An August 26, 2000, article, "Long-term  
          effect of bone-marrow transplantation for childhood-onset  
          cerebral X-linked adrenoleukodystrophy," in the Lancet medical  
          journal found the long-term beneficial effect of bone marrow  
          transplantation when the procedure is done at an early stage of  
          the disease.

           CNSP  .  According to DPH's Internet 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.

           Adding new screenings  .  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  

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          RUSP until they are approved by the Secretary, states do not  
          generally implement screenings before the final approval.  While  
          DPH's Director has the authority to add new disorders  
          administratively, in the past new disorders have been added  
          after final federal approval through legislation in conjunction  
          with a fee increase to support and maintain the screening  
          expansion.  CNSP statute does not currently require screening  
          for any disorders that are not on the RUSP.  
          
          In January 2014, the DACHDNC voted to move ALD newborn screening  
          to an external evidence review committee.  Approval from the  
          review committee is expected in early 2015, after which the HHS  
          Secretary would need to give final approval.  There have been  
          instances in the past where the HHS Secretary rejected adding a  
          screening to the RUSP even after the review committee gave its  
          approval.

           Prior Legislation

           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.  This bill 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.  This  
          bill 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. 

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           FISCAL EFFECT  :    Appropriation:  Yes   Fiscal Com.:  Yes    
          Local:  No

          According to the Senate Appropriations Committee:

           One-time costs of about $2 million for technical and  
            administrative activities to add ALD to the newborn screening  
            program (Genetic Disease Testing Fund).

           Annual screening costs of $4.7 million per year, covered by  
            fees (Genetic Disease Testing Fund).  Adding ALD to the  
            newborn screening program requires DPH to raise the fee  
            charged for screening by $11 per birth.

           Increased costs or about $2.6 million per year to the Medi-Cal  
            program to pay the fees charged to support the newborn  
            screening program for births paid for by Medi-Cal (General  
            Fund and federal funds).

           Increased costs of about $50,000 per year to CalPERS to pay  
            the fees charged to support the newborn screening program for  
            births paid for by CalPERS (various funds).

           Likely long-term savings due to improved clinical outcomes  
            from early testing and treatment (various funds).  According  
            to information provided by physicians treating children with  
            ALD, clinical outcomes can be greatly improved by early  
            diagnosis and treatment.  Without screening for ALD, a  
            diagnosis often is not made until serious symptoms have  
            occurred.  At that point, treatment is much less effective and  
            the child is at high risk for death or permanent disability.   
            On the other hand, if treatment is provided at the first sign  
            that ALD is occurring (through an MRI diagnosis, before  
            clinical symptoms are observed) long-term outcomes are greatly  
            improved. 

           SUPPORT  :   (Verified  8/22/14)

          The Myelin Project (source) 
          Adrenoleukodystrophy Foundation
          Be A Hero Become A Donor Foundation
          Brian's Hope
          California Professional Firefighters

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          Croda International
          Fight ALD - Fighting Illness through Education
          International Pemphigus & Pemphigoid Foundation
          Moser Center for Leukodystrophies at Kennedy Krieger Institute  
          at Johns Hopkins Medical School
          Stop ALD Foundation
          University of Minnesota, Pediatric Blood and Marrow  
          Transplantation
          AFSCME, AFL-CIO
          California Academy of Physician Assistants
          California Healthcare Institute
          Children's Hospital and Research Center Oakland
          Corpus Christi Parish
          Duke University Pediatric Blood and Marrow Transplant Program  
          and Carolinas                                               Cord  
          Blood Bank

           OPPOSITION  :    (Verified  8/22/14)

          Department of Finance

           ARGUMENTS IN SUPPORT  :   Supporters argue that early detection of  
          ALD is crucial and helps avoid undue suffering, as well as  
          emotional and financial costs associated with treatment and care  
          of the full onset of ALD.  They further argue that newborn  
          screening for ALD is simple, accurate, and cost-effective, using  
          blood spots already used for screening of other diseases, and  
          that treatment is most effective if begun before symptoms first  
          appear. 
          
           ARGUMENTS IN OPPOSITION  :    The Department of Finance (DOF)  
          opposes this bill because they say it could impose additional  
          General Fund costs for the Medi-Cal program. DOF additionally  
          states that this bill is premature pending the federal review  
          process currently underway. 
           
           
           ASSEMBLY FLOOR  :  79-0, 5/28/14
          AYES:  Achadjian, Alejo, Allen, Ammiano, Bigelow, Bloom,  
            Bocanegra, Bonilla, Bonta, Bradford, Brown, Buchanan, Ian  
            Calderon, Campos, Chau, Chávez, Chesbro, Conway, Cooley,  
            Dababneh, Dahle, Daly, Dickinson, Donnelly, Eggman, Fong, Fox,  
            Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gonzalez, Gordon,  
            Gorell, Gray, Grove, Hagman, Hall, Harkey, Roger Hernández,  

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            Holden, Jones, Jones-Sawyer, Levine, Linder, Logue, Lowenthal,  
            Maienschein, Mansoor, Medina, Melendez, Mullin, Muratsuchi,  
            Nazarian, Nestande, Olsen, Pan, Patterson, Perea, John A.  
            Pérez, V. Manuel Pérez, Quirk, Quirk-Silva, Rendon,  
            Ridley-Thomas, Rodriguez, Salas, Skinner, Stone, Ting, Wagner,  
            Waldron, Weber, Wieckowski, Wilk, Williams, Yamada, Atkins
          NO VOTE RECORDED:  Vacancy


          JL:nl  8/22/14   Senate Floor Analyses 

                           SUPPORT/OPPOSITION:  SEE ABOVE

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