BILL ANALYSIS Ó Senate Appropriations Committee Fiscal Summary Senator Kevin de León, Chair AB 1559 (Pan) - Newborn screening program. Amended: May 23, 2014 Policy Vote: Health 8-0 Urgency: No Mandate: No Hearing Date: June 30, 2014 Consultant: Brendan McCarthy This bill meets the criteria for referral to the Suspense File. Bill Summary: AB 1559 would add adrenoluekodystrophy (ALD) to the state's newborn screening program. Fiscal Impact: 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 would require the Department of Public Health 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 AB 1559 (Pan) Page 1 the first sign that ALD is occurring (through an MRI diagnosis, before clinical symptoms are observed) long-term outcomes are greatly improved. 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 for each birth in the state. The current fee for newborn screening is set at $111.70. Proposed Law: AB 1559 would add adrenoluekodystrophy (ALD) to the state's newborn screening program. Related Legislation: SB 1334 (Walters) would have required the Department of Public Health to expand the newborn screening program to test newborns in Orange County for Krabbe disease. That bill was not heard in the Senate Health Committee. SB 224 (Walters) would have required the Department of Public Health to expand the newborn screening program to test newborns in Orange County for Krabbe disease. That bill was held on the Assembly Appropriations Committee's Suspense File. AB 395 (Pan, Statutes of 2011) expanded the newborn screening program to include severe combined immunodeficiency. Staff Comments: Under current law, the Department is authorized to increase the fee associated with newborn screening to cover the costs of the program. The Department indicates that under the bill the current fee would have to be raised by $11 per birth. Medi-Cal and other public health care programs that pay for labor and delivery costs would be required to pay the additional fees. Neither the advisory committee to the federal Health and Human Services Agency nor the advisory committee to the Department of Public Health have recommended including ALD in new born screening programs at this time. However, in January 2014, the federal advisory committee voted to move screening for ALD to an AB 1559 (Pan) Page 2 external evidence review committee. The recommendation from that external evidence review committee is expected in early 2015 with subsequent decisions by the advisory committee and the Secretary of the federal Health and Human Services Agency.