BILL ANALYSIS Ó SB 1095 Page 1 SENATE THIRD READING SB 1095 (Pan) As Amended August 15, 2016 Majority vote SENATE VOTE: 39-0 ------------------------------------------------------------------ |Committee |Votes|Ayes |Noes | | | | | | | | | | | | | | | | |----------------+-----+----------------------+--------------------| |Health |17-0 |Wood, Maienschein, | | | | |Bonilla, Burke, | | | | |Campos, Chiu, Gomez, | | | | |Roger Hernández, | | | | |Lackey, Nazarian, | | | | |Patterson, | | | | | | | | | | | | | | |Ridley-Thomas, | | | | |Rodriguez, Santiago, | | | | |Steinorth, Thurmond, | | | | |Waldron | | | | | | | |----------------+-----+----------------------+--------------------| |Appropriations |20-0 |Gonzalez, Bigelow, | | | | |Bloom, Bonilla, | | | | |Bonta, Calderon, | | SB 1095 Page 2 | | |Chang, Daly, Eggman, | | | | |Gallagher, Eduardo | | | | |Garcia, Holden, | | | | |Jones, Obernolte, | | | | |Quirk, Santiago, | | | | |Wagner, Weber, Wood, | | | | |McCarty | | | | | | | | | | | | ------------------------------------------------------------------ SUMMARY: Requires the Department of Public Health (DPH) to expand statewide screening of newborns to include screening for any disease that is detectable in blood samples within two years of the disease being adopted by the federal Recommended Uniform Screening Panel (RUSP). EXISTING LAW: 1)Requires DPH to establish a genetic disease unit to coordinate all DPH programs in the area of genetic disease that will promote a statewide program of information, testing, and counseling services and to have the responsibility of designating tests and regulations to be used in executing this program and to have the responsibility of designating tests and regulations to be used in executing the California Newborn Screening Program (CNSP). 2)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. 3)Requires statewide screening of newborns to include tandem SB 1095 Page 3 mass spectrometry screening for fatty acid oxidation, amino acid, and organic acid disorders and congenital adrenal hyperplasia. Requires screening of newborns to include screening for severe combined immunodeficiency, as soon as possible. 4)Requires DPH to expand statewide screening of newborns to include screening for adrenoleukodystrophy (ALD) as soon as ALD is adopted by the federal RUSP. FISCAL EFFECT: According to the Assembly Appropriations Committee: 1)One-time costs of $2.4 million and ongoing costs of $4.3 million per year to screen for two diseases (MPS-1 and Pompe disease) that have already been approved for inclusion in the federal panel (Genetic Disease Testing Fund). The ongoing costs would cover initial screening tests, follow-up tests for positive results, and initial case management for confirmed diagnoses. The Genetic Disease Screening Program is fee-supported; most health insurance, including Medi-Cal, covers the screening fee. The fee has increased pursuant to the 2016-17 Budget Act, and is currently $130.25. Adding these two conditions would require an additional fee increase of about $9. 2)Ongoing costs of over $2 million per year for coverage of the increased screening fee by the Medi-Cal program (General Fund/federal). Medi-Cal covers the cost of the screening exam and Medi-Cal pays for roughly 50% of the births in the state. 3)Unknown future costs to expand newborn screening program to add screening tests for new diseases as they are adopted as part of the federal panel (Genetic Disease Testing Fund). SB 1095 Page 4 Costs vary by disease; recent additions have generally cost in the low millions per condition, per year. Screening fees will be adjusted to support the additional projected expenditures. 4)Potential long-term savings due to improved clinical outcomes from early testing and treatment (various funds). COMMENTS: According to the author, newborn screening for rare diseases is a critical, cost-effective public health intervention, as diagnosing diseases at birth leads to earlier medical intervention. In turn, early treatment saves and improves children's and families' lives and reduces medical costs by eliminating or ameliorating the devastating consequences of rare and treatable diseases. California's current approach to reviewing and approving screening for additional diseases has created a lag behind current medical recommendations. A study in the journal Pediatrics found that California saves $9.32 in health care costs for every dollar spent on newborn screening. In 1966 California began its CNSP with the testing of phenylketonuria. Since its creation, the CNSP has been expanded several times as new discoveries are made and tests developed and now screens for more than 70 disorders. Diseases have been continually added through regulation and legislation. The last disease added by statute was ALD in 2014. ALD was added to the RUSP in February of 2016. The California Hospital Association states that the bill provides a forward thinking approach to properly and thoughtfully expanding newborn screening by providing that California screen for diseases that are detectable in blood samples and listed on the RUSP as certified by the Health and Human Services (HHS) Secretary. The RUSP list is periodically updated through a thorough, deliberative review process SB 1095 Page 5 involving a committee of experts in newborn screening. By allowing California to take advantage of the work done by these medical experts, we can remove the obstacles to needed testing and minimize the suffering that comes from untreated diseases. The EveryLife Foundation for Rare Diseases (EveryLife) states that the bill provides a much needed, practical, science-based approach to improving public health for all of California's Children. This bill allows for the earliest diagnosis of disease and access to potentially life-saving and life-altering treatments for babies. Early treatment is vital in ensuring the best possible life-altering health outcomes for children. In many cases, early detection can avert costly and risky medical procedures later in life. A study in the journal Pediatrics found that California saves $9.32 in health care costs for every dollar spent on newborn screenings. EveryLife states that this bill will ensure that babies born in California, particularly those that will be affected by debilitating and life-threatening diseases, are diagnosed and treated at the earliest age possible and without unconscionable delay. This approach is critical for improving health outcomes for children and providing the brightest future for all babies born in California. The California Right to Life, Inc. argues that this bill does not correct the issue of the limited ability to opt out of the screening program for religious beliefs or practices and may even bring discrimination against parents or guardians who do opt out. DPH states that if it is required to expand the current Newborn Screening program to include other diseases as soon as a disease is adopted by the RUSP, it will need additional time to plan and implement a quality screening program that addresses all of the issues addressed in the public health feasibility and readiness assessments provided to the Secretary of HHS as part of the approval process for new RUSP diseases. SB 1095 Page 6 Analysis Prepared by: Paula Villescaz / HEALTH / (916) 319-2097 FN: 0004129