BILL ANALYSIS                                                                                                                                                                                                    �




                   Senate Appropriations Committee Fiscal Summary
                            Senator Kevin de Le�n, Chair


          SB 224 (Walters) - Newborn screening program.
          
          Amended: As introduced          Policy Vote: Health 9-0
          Urgency: No                     Mandate: No
          Hearing Date: April 15, 2013                            
          Consultant: Brendan McCarthy    
          
          This bill meets the criteria for referral to the Suspense File.
          
          
          Bill Summary: SB 224 would require the Department of Public  
          Health to expand the existing newborn screening program to  
          include screening for two additional conditions - Hurler  
          Syndrome (MPS 1) and Krabbe disease.

          Fiscal Impact: 
              One-time costs to the Department of Public Health to  
              upgrade information technology systems and adopt regulations  
              of about $5 million (over three years, Genetic Disease  
              Testing Fund).

              Ongoing costs to expand newborn screening of about $3.8  
              million per year, covered by fees (Genetic Disease Testing  
              Fund).

              Increased costs to Medi-Cal of $1.7 million per year for  
              testing fees (50% General Fund, 50% federal funds).

              Increased costs to the Access for Infants and Mothers  
              Program of $55,000 per year (35% Proposition 99 funds, 65%  
              federal funds).

              Increased costs to CalPERS of $37,000 per year for testing  
              fees (55% General Fund, 45% special funds).

              Earlier diagnosis of infants covered by public health care  
              programs with one of these conditions may result in  
              increased costs, to the extent that ongoing treatments such  
              as enzyme replacement therapy begin earlier than they would  
              without screening for these conditions. The extent to which  
              this will actually increase costs is unknown.









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              Whether early screening and diagnosis will improve medical  
              outcomes and reduce future treatment costs to public  
              healthcare programs is unknown, given the limited  
              information available on treatment outcomes.


          Background: The Department of Public Health operates the Genetic  
          Disease Testing Program, which screens all newborns in the state  
          for more than 70 inherited conditions. Both the federal  
          government and the Department have advisory committees that make  
          recommendations on new conditions that should be added to the  
          federal screening guidelines and the state screening program.  
          The Genetic Disease Testing Program is funded by fees assessed  
          on health plans and insurers (or the individual) for each birth  
          in the state. The current fee for newborn screening is set at  
          $112.70.

          Proposed Law: SB 224 would require the Department of Public  
          Health to expand the existing newborn screening program to  
          include screening for two additional conditions - Hurler  
          Syndrome (MPS 1) and Krabbe disease. This additional screening  
          requirement would sunset on January 1, 2019.

          Related Legislation: 
              SB 1072 (Strickland) of 2012 was identical to this bill.  
              That bill was held on this committee's Suspense File.

              AB 395 (Pan) Chapter 461 of 2011 added severe combined  
              immunodeficiency to the newborn screening test.

          Staff Comments: Under current law, the Department is authorized  
          to increase the fee associated with newborn screening to cover  
          the costs of the program. Based on staff estimates of potential  
          cost increases, the current fee would have to be raised by about  
          $7 per birth (with an additional increase of about $4 per birth  
          for the first three years to pay for information technology  
          upgrades). Medi-Cal and other public health care programs that  
          pay for labor and delivery costs would be required to pay the  
          additional fees. 

          At this time, the long-term efficacy of the available treatments  
          for these two conditions (including enzyme replacement therapy  
          and stem cell or bone marrow transplantation) is not well  
          documented. In addition, early screening for these conditions  








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          will likely identify individuals that may only manifest symptoms  
          later in life. Therefore, it is not possible to determine  
          whether early diagnosis of these conditions will either improve  
          health outcomes or reduce overall health care costs.

          Neither the advisory committee to the federal Health and Human  
          Services Agency nor the advisory committee to the Department of  
          Public Health have recommending including these conditions in  
          newborn screening programs at this time.