Synopsis As Introduced Amends the Newborn Metabolic Screening Act. Requires the Department of Public Health to provide all newborns with screening tests for the presence of adrenoleukodystrophy (ALD). Provides that testing shall begin within 12 months following the occurrence of various events, including: (1) the development and validation of a reliable methodology; (2) the availability of any necessary reagents; (3) the establishment and verification of relevant and appropriate performance specifications; (4) the availability of quality assurance testing; (5) the acquisition and installment of necessary equipment; (6) the establishment of precise threshold values ensuring defined disorder identification for ALD; (7) the authentication of pilot testing; and (8) the authentication of achieving the potential of high throughput standards. Allows the Department to implement an additional fee for the screening prior to beginning the testing in order to accumulate the resources for start-up and other costs associated with implementation of the screening and thereafter to support the costs associated with screening and follow-up programs for adrenoleukodystrophy.
Replaces everything after the enacting clause with the introduced bill. Makes the following changes: requires adrenoleukodystrophy testing to begin within 18 (instead of 12) months following the occurrence of certain events. Further amends the Newborn Metabolic Screening Act. Provides that beginning July 1, 2015, the base fee for newborn screening services shall be $118. Allows the Department of Public Health to levy additional fees according to a fee structure developed by the Department. Effective July 1, 2015.
Senate Committee Amendment No. 1 Provides that any fee for a new genetic, metabolic, or congenital disorder screening for newborns, including adrenoleukodystrophy, may not be implemented sooner than 6 months prior to the beginning of testing.