Expands the newborn screening requirements to include spinal muscular atrophy (SMA) and Hunter syndrome
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FIRST REGULAR SESSION
SENATE COMMITTEE SUBSTITUTE FOR HOUSE COMMITTEE SUBSTITUTE FOR
HOUSE BILL NO. 66
99TH GENERAL ASSEMBLY
Reported from the Committee on Seniors, Families and Children, March 30, 2017, with recommendation that the Senate Committee Substitute do pass.
ADRIANE D. CROUSE, Secretary.
To repeal sections 191.331 and 191.332, RSMo, and to enact in lieu thereof two new
sections relating to newborn screening requirements.
Be it enacted by the General Assembly of the State of Missouri, as follows:
Section A. Sections 191.331 and 191.332, RSMo, are repealed and two new sections enacted in lieu thereof, to be known as sections 191.331 and 191.332, to read as follows:
191.331. 1. Every infant who is born in this state shall be tested for phenylketonuria and such other metabolic or genetic diseases as are prescribed by the department. The test used by the department shall be dictated by accepted medical practice and such tests shall be of the types approved by the department. All newborn screening tests required by the department shall be performed by the department of health and senior services laboratories. The attending physician, certified nurse midwife, public health facility, ambulatory surgical center or hospital shall assure that appropriate specimens are collected and submitted to the department of health and senior services laboratories within twenty-four hours of collection. The laboratories shall process the specimens within twenty-four hours of receipt. 2. All physicians, certified nurse midwives, public health nurses and administrators of ambulatory surgical centers or hospitals shall report to the department all diagnosed cases of phenylketonuria and other metabolic or genetic diseases as designated by the department. The department shall prescribe and furnish all necessary reporting forms. 3. The department shall develop and institute educational programs concerning phenylketonuria and other metabolic and genetic diseases and assist
SCS HCS HB 66 parents, physicians, hospitals and public health nurses in the management and basic treatment of these diseases. 4. The provisions of this section shall not apply if the parents of such child object to the tests or examinations provided in this section on the grounds that such tests or examinations conflict with their religious tenets and practices. 5. As provided in subsection 4 of this section, the parents of any child who fail to have such test or examination administered after notice of the requirement for such test or examination shall be required to document in writing such refusal. All physicians, certified nurse midwives, public health nurses and administrators of ambulatory surgical centers or hospitals shall provide to the parents or guardians a written packet of educational information developed and supplied by the department of health and senior services describing the type of specimen, how it is obtained, the nature of diseases being screened, and the consequences of treatment and nontreatment. The attending physician, certified nurse midwife, public health facility, ambulatory surgical center or hospital shall obtain the written refusal and make such refusal part of the medical record of the infant. 6. Notwithstanding the provisions of section 192.015 to the contrary, the department may, by rule, annually determine and impose a reasonable fee for each newborn screening test made in any of its laboratories. The department may collect the fee from any entity or individual described in subsection 1 of this section in a form and manner established by the department. Such fee shall be considered as a cost payable to such entity by a health care third-party payer, including, but not limited to, a health insurer operating pursuant to chapter 376, a domestic health services corporation or health maintenance organization operating pursuant to chapter 354, and a governmental or entitlement program operating pursuant to state law. Such fee shall not be considered as part of the internal laboratory costs of the persons and entities described in subsection 1 of this section by such health care third-party payers. No individual shall be denied screening because of inability to pay. Such fees shall be deposited in a separate account in the public health services fund created in section 192.900, and funds in such account shall be used for the support of the newborn screening program and activities related to the screening, diagnosis, and treatment, including special dietary products, of persons with metabolic and genetic diseases; and follow-up activities that ensure that diagnostic evaluation, treatment and management is available and accessible once an at-risk family is identified through initial
(1) Applicants ages birth to five years old meeting the qualifications under
SCS HCS HB 66 screening; and for no other purpose. These programs may include education in these areas and the development of new programs related to these diseases. 7. Subject to appropriations provided for formula for the treatment of inherited diseases of amino acids and organic acids, the department shall provide such formula to persons with inherited diseases of amino acids and organic acids subject to the conditions described in this subsection. State assistance pursuant to this subsection shall be available to an applicant only after the applicant has shown that the applicant has exhausted all benefits from third-party payers, including, but not limited to, health insurers, domestic health services corporations, health maintenance organizations, Medicare, Medicaid and other government assistance programs. following: subsection 7 of this section; (2) Applicants between the ages of six to eighteen meeting the qualifications under subsection 7 of this section and whose family income is below three hundred percent of the federal poverty level; (3) Applicants between the ages of six to eighteen meeting the qualifications under subsection 7 of this section and whose family income is at three hundred percent of the federal poverty level or above. For these applicants, the department shall establish a sliding scale of fees and monthly premiums to be paid in order to receive assistance under subsection 7 of this section; and (4) Applicants age nineteen and above meeting the qualifications under subsection 7 of this section and who are eligible under an income-based means test established by the department to determine eligibility for the assistance under subsection 7 of this section. 9. The department shall have authority over the use, retention, and disposal of biological specimens and all related information collected in connection with newborn screening tests conducted under subsection 1 of this section. The use of such specimens and related information shall only be made for public health purposes and shall comply with all applicable provisions of federal law. The department may charge a reasonable fee for the use of such specimens for public health research and preparing and supplying specimens for research proposals approved by the department.
191.332. 1. By January 1, 2002, the department of health and senior
(G-6-PD), MCAD and other
SCS HCS HB 66 services shall, subject to appropriations, expand the newborn screening requirements in section 191.331 to include potentially treatable or manageable disorders, which may include but are not limited to cystic fibrosis, galactosemia, biotinidase deficiency, congenital adrenal hyperplasia, maple syrup urine disease (MSUD) and other amino acid disorders, glucose-6-phosphate dehydrogenase deficiency fatty acid oxidation disorders, methylmalonic acidemia, propionic acidemia, isovaleric acidemia and glutaric acidemia Type I. 2. By January 1, 2017, the department of health and senior services shall, subject to appropriations, expand the newborn screening requirements in section 191.331 to include severe combined immunodeficiency (SCID), also known as bubble boy disease. The department may increase the fee authorized under subsection 6 of section 191.331 to cover any additional costs of the expanded newborn screening requirements under this subsection. 3. By January 1, 2019, the department of health and senior services shall, subject to appropriations, expand the newborn screening requirements in section 191.331 to include spinal muscular atrophy (SMA) and Hunter syndrome (MPS II). The department may increase the fee authorized under subsection 6 of section 191.331 to cover any additional costs of the expanded newborn screening requirements under this subsection. To help fund initial costs incurred by the state, the department shall apply for available newborn screening grant funding specific to screening for spinal muscular atrophy and Hunter syndrome. The department shall have discretion in accepting the terms of such grants. 4. The department of health and senior services may promulgate rules to implement the provisions of this section. No rule or portion of a rule promulgated pursuant to the authority of this section shall become effective unless it has been promulgated pursuant to chapter 536.