To repeal section 191.331, RSMo 1994, relating to newborn testing, and to enact in lieu thereof one new section relating to the same subject.

Be it enacted by the General Assembly of the State of Missouri, as follows:

     Section A. Section 191.331, RSMo 1994, is repealed and one new section enacted in lieu thereof, to be known as section 191.331, to read as follows: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 department shall [make such rules pertaining to] determine such tests as shall be dictated by accepted medical practice, and 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 laboratories. [The attending physician, public health facility or hospital shall assure that appropriate specimens are collected and submitted to the department of health laboratories.]

     2. All physicians, licensed 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 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. [Except] 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 [by the physician or hospital are guilty of a class A misdemeanor, and upon conviction thereof shall be punished as provided by law] shall be required to document in writing said refusal. All physicians, licensed 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 describing the type of specimens obtained, how it is obtained, the nature of the diseases being screened and the consequences of treatment and nontreatment. The attending physician, licensed certified nurse midwife, public health facility, ambulatory surgical center or hospital shall obtain the written refusal and make it part of the medical record.

     6. Notwithstanding the provisions of section 192.015, RSMo, 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. Fees imposed and collected by the department from any entity or individual described in subdivision 1 of this section may be considered as costs payable to such entities by health care third party payers, including, but not limited to, health insurers operating under chapter 376, RSMo, domestic health services corporations operating under chapter 354, RSMo, health maintenance organizations operating under chapter 354, and governmental benefit or entitlement programs operating under state law. Such health care third party payers shall not consider these fees as part of the internal lab costs of physicians, licensed certified nurse midwives, public health facilities, ambulatory surgical centers or hospitals. 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, RSMo, and funds in such account shall be used for the support of the laboratory costs for the required newborn screening. [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 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. [The department shall establish an income-based means test to be used to determine eligibility for the special dietary products made available under subsection 6 of this section.

     8. No rule or portion of a rule promulgated under the authority of sections 191.300 to 191.380 shall become effective unless it has been promulgated pursuant to the provisions of section 536.024, RSMo.] 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 acid and organic acid if the total adjusted gross income of that person, or if a minor or incompetent the total adjusted gross income of that person's family or legal guardian, does not exceed fifty-thousand dollars. State assistance pursuant to this subsection shall be available to an applicant only after he has shown that he 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.