House File 459 HOUSE FILE BY MASCHER Passed House, Date Passed Senate, Date Vote: Ayes Nays Vote: Ayes Nays Approved A BILL FOR 1 An Act providing for the establishment of an expanded newborn 2 screening program, establishing a fee and a fund, and making 3 an appropriation. 4 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 5 TLSB 2867HH 80 6 rn/cl/14 PAG LIN 1 1 Section 1. NEW SECTION. 135.26 EXPANDED SCREENING 1 2 PROGRAM == GENETIC AND METABOLIC DISORDERS == FEE == FUND. 1 3 1. DEFINITIONS. As used in this section, unless the 1 4 context otherwise requires: 1 5 a. "Accredited laboratory" means any laboratory that holds 1 6 a valid certificate issued under the clinical laboratory 1 7 improvement amendments of 1988, 42 U.S.C. } 263a, as amended, 1 8 and that reports its screening results by using normal 1 9 pediatric reference ranges. 1 10 b. "Expanded screening" means screening for genetic and 1 11 metabolic disorders, including but not limited to amino acid 1 12 disorders, organic acid disorders, fatty acid disorders, and 1 13 other abnormal profiles, in newborn infants that can be 1 14 detected through the use of a tandem mass spectrometer. 1 15 c. "Tandem mass spectrometer" means an analytical 1 16 instrument used to detect numerous genetic and metabolic 1 17 disorders at one time. 1 18 2. Beginning July 1, 2004, all newborns shall be subjected 1 19 to expanded screening for the presence of genetic, endocrine, 1 20 or other metabolic disorders specified in paragraph "b", and 1 21 such other metabolic disorders as the department may deem 1 22 necessary. In establishing the expanded screening program 1 23 pursuant to this section, the department shall: 1 24 a. Implement an intensive educational program among 1 25 physicians, hospitals, public health nurses, and the public 1 26 concerning the diseases phenylketonuria, hypothyroidism, 1 27 galactosemia, and other metabolic disorders. The educational 1 28 program shall include information about the nature of the 1 29 disorders and examinations for their detection in early 1 30 infancy, in order that measures may be taken to prevent 1 31 resulting mental retardation. 1 32 b. Provide all newborns with expanded screening through 1 33 local health departments for phenylketonuria, galactosemia, 1 34 hypothyroidism, congenital adrenal hyperplasia, biotinidase 1 35 deficiency, and sickling disorders, as well as other amino 2 1 acid disorders, organic acid disorders, fatty acid oxidation 2 2 disorders, and other abnormalities detectable through the use 2 3 of a tandem mass spectrometer. 2 4 c. Supply the necessary treatment product where 2 5 practicable for diagnosed cases for as long as medically 2 6 indicated, when the product is not available through other 2 7 state agencies. 2 8 d. Arrange for or provide, if determined necessary, public 2 9 health nursing, nutrition, and social services, and clinical 2 10 consultation. 2 11 e. Require that all specimens collected via the expanded 2 12 screening be submitted for testing to an accredited laboratory 2 13 designated by the department to perform such tests, with the 2 14 results of the tests reported to the department. The 2 15 department shall establish a reasonable fee to cover the cost 2 16 of providing the expanded screening, and shall deposit the 2 17 fees collected into a special fund created within the state 2 18 treasury and designated as the metabolic screening and 2 19 treatment fund. Additional state and federal funds for 2 20 expenses related to metabolic screening, follow=up, and 2 21 treatment may also be deposited into the fund. Moneys 2 22 deposited into the fund are appropriated to the department 2 23 solely for the purpose of providing metabolic screening, 2 24 follow=up, and treatment. Notwithstanding section 8.33, 2 25 moneys deposited into the special fund that remain 2 26 unencumbered or unobligated at the close of the fiscal year 2 27 shall not revert to any other fund but shall remain available 2 28 for expenditure for the purpose designated in future fiscal 2 29 years. Notwithstanding section 12C.7, subsection 2, interest 2 30 or earnings on moneys deposited into the special fund shall be 2 31 credited to and remain a part of the special fund. 2 32 3. The expanded screening program established pursuant to 2 33 this section shall not be construed to prohibit any licensed 2 34 medical facility from collecting additional specimens for 2 35 testing for metabolic or neonatal diseases or any other 3 1 diseases or conditions which the facility deems necessary. 3 2 4. The provisions of this section shall not apply if a 3 3 newborn's parent or legal guardian submits a signed affidavit 3 4 to a physician or other person whose duty it is to administer 3 5 and report the results of the expanded screening stating that 3 6 the expanded screening conflicts with the tenets and practices 3 7 of a recognized religious denomination of which the newborn, 3 8 parent, or legal guardian is an adherent or member. 3 9 5. The department shall adopt rules relating to 3 10 administration of the educational program, expanded screening, 3 11 and reporting requirements required pursuant to this section. 3 12 EXPLANATION 3 13 This bill provides for the establishment of an expanded 3 14 screening program for newborns for specified genetic and 3 15 metabolic disorders, including phenylketonuria, beginning July 3 16 1, 2004. The bill defines "expanded screening" to mean 3 17 screening for genetic and metabolic disorders, including but 3 18 not limited to amino acid disorders, organic acid disorders, 3 19 fatty acid disorders, and other abnormal profiles, in newborn 3 20 infants that can be detected through the use of a tandem mass 3 21 spectrometer. 3 22 The bill provides that in establishing the expanded 3 23 screening program, the Iowa department of public health shall 3 24 implement an intensive educational program among physicians, 3 25 hospitals, public health nurses, and the public concerning the 3 26 diseases phenylketonuria, hypothyroidism, galactosemia, and 3 27 other metabolic disorders, which shall include information 3 28 about the nature of the disorders and examinations for their 3 29 detection in early infancy. The bill provides that the 3 30 department shall provide all newborns with expanded screening 3 31 through local health departments for phenylketonuria, 3 32 galactosemia, hypothyroidism, congenital adrenal hyperplasia, 3 33 biotinidase deficiency, and sickling disorders, as well as 3 34 other amino acid disorders, organic acid disorders, fatty acid 3 35 oxidation disorders, and other abnormalities detectable 4 1 through the use of a tandem mass spectrometer. 4 2 The bill provides that the department shall supply the 4 3 necessary treatment product where practicable for diagnosed 4 4 cases for as long as medically indicated, when the product is 4 5 not available through other state agencies; arrange for or 4 6 provide necessary public health nursing, nutrition, and social 4 7 services, and clinical consultation; and require that all 4 8 specimens collected be submitted for testing to an accredited 4 9 laboratory designated by the department to perform such tests, 4 10 and require that the results of the tests be reported to the 4 11 department. 4 12 The bill provides that the department shall establish a 4 13 reasonable fee to cover the cost of providing the expanded 4 14 screening, and shall deposit the fees collected into a special 4 15 fund created within the state treasury and designated as the 4 16 metabolic screening and treatment fund. The bill provides 4 17 that additional state and federal funds for expenses related 4 18 to metabolic screening, follow=up, and treatment may also be 4 19 deposited into the fund, and that moneys deposited into the 4 20 fund are appropriated to the department solely for the purpose 4 21 of providing metabolic screening, follow=up, and treatment. 4 22 The bill provides that the expanded screening program shall 4 23 not be construed to prohibit any licensed medical facility 4 24 from collecting additional specimens for testing for metabolic 4 25 or neonatal diseases or any other diseases or conditions which 4 26 the facility deems necessary. The bill additionally provides 4 27 that the program requirements shall not apply if a newborn's 4 28 parent or legal guardian submits a signed affidavit objecting 4 29 to the screening on the basis of a religious conflict. The 4 30 bill provides that the department shall adopt rules relating 4 31 to administration of the educational program, expanded 4 32 screening, and reporting requirements. 4 33 LSB 2867HH 80 4 34 rn/cl/14