Bill Text: MI HB4078 | 2023-2024 | 102nd Legislature | Introduced
Bill Title: Health: screening; gene screening for MTHFR for newborns; require, and require department to provide certain notices. Amends sec. 5431 of 1978 PA 368 (MCL 333.5431) & adds sec. 5431a. TIE BAR WITH: HB 4049'23
Spectrum: Partisan Bill (Republican 2-0)
Status: (Introduced) 2023-02-15 - Bill Electronically Reproduced 02/14/2023 [HB4078 Detail]
Download: Michigan-2023-HB4078-Introduced.html
HOUSE BILL NO. 4078
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending section 5431 (MCL 333.5431), as amended by 2002 PA 691, and by adding section 5431a.
the people of the state of michigan enact:
Sec. 5431. (1) A health professional in charge of the care of a newborn infant or, if none, the health professional in charge at the birth of an infant shall administer or cause to be administered to the infant a test for each of the following:
(a) Phenylketonuria.
(b) Galactosemia.
(c) Hypothyroidism.
(d) Maple syrup urine disease.
(e) Biotinidase deficiency.
(f) Sickle cell anemia.
(g) Congenital adrenal hyperplasia.
(h) Medium-chain acyl-coenzyme A dehydrogenase deficiency.
(i) Methylenetetrahydrofolate reductase (MTHFR) gene variant.
(j) (i) Other treatable but otherwise disabling conditions as designated by the department.
(2) The informed consent requirements of sections 17020 and 17520 do not apply to the tests required under subsection (1). The tests required under subsection (1) shall must be administered and reported within a time and under conditions prescribed by the department. The department may require that the tests be performed by the department.
(3) If the results a result of a test administered under subsection (1) are (1)(a) to (h) or (j) is positive, the results shall result must be reported to the infant's parents, guardian, or person in loco parentis. If the result of a test administered under subsection (1)(i) is positive or negative, the result must be reported to the infant's parents, guardian, or person in loco parentis and, if the test result is positive, the infant's parent, guardian, or person in loco parentis must be provided with the notice described in section 5431a. A person is in compliance with this subsection if the person makes a good faith good-faith effort to report the positive test results to the infant's parents, guardian, or person in loco parentis.
(4) Subject to the annual adjustment required under this subsection and subject to subsection (6), if the department performs 1 or more of the tests required under subsection (1), the department may charge a fee for the tests of not more than $53.71. The department shall adjust the amount prescribed by this subsection annually by an amount determined by the state treasurer to reflect the cumulative annual percentage change in the Detroit consumer price index. Consumer Price Index. As used in this subsection, "Detroit consumer price index" Consumer Price Index" means the most comprehensive index of consumer prices available for the Detroit area from the bureau of labor statistics of Bureau of Labor Statistics of the United States department of labor.Department of Labor.
(5) A person who violates this section or a rule promulgated under this part is guilty of a misdemeanor.
(6) The department shall provide for a hardship waiver of the fee authorized under subsection (4) under circumstances found appropriate by the department.
(7) The department shall do all of the following in regard to the blood specimens taken for purposes of conducting the tests required under subsection (1):
(a) By April 1, 2000, develop a schedule for the retention and disposal of the blood specimens used for the tests after the tests are completed. The schedule shall must meet at least all of the following requirements:
(i) Be consistent with nationally recognized standards for laboratory accreditation and federal law.
(ii) Require that the disposal be conducted in compliance with section 13811.
(iii) Require that the disposal be conducted in the presence of a witness. For purposes of this subparagraph, the witness may be an individual involved in the disposal or any other individual.
(iv) Require that a written record of the disposal be made and kept, and that the witness required under subparagraph (iii) signs the record.
(b) Allow the blood specimens to be used for medical research during the retention period established under subdivision (a), as long as the medical research is conducted in a manner that preserves the confidentiality of the test subjects and is consistent to protect human subjects from research risks under subpart A of part 46 of subchapter A of title 45 of the code of federal regulations.45 CFR 46.101 to 46.124.
(8) The department shall rewrite its pamphlet explaining the requirements of this section when the supply of pamphlets in existence on March 15, 2000 is exhausted. When the department rewrites the explanatory pamphlet, it the department shall include at least all of the following information in the pamphlet:
(a) The nature and purpose of the testing program required under this section, including, but not limited to, a brief description of each condition or disorder listed in subsection (1).
(b) The purpose and value of the infant's parent, guardian, or person in loco parentis retaining a blood specimen obtained under subsection (9) in a safe place.
(c) The department's schedule for retaining and disposing of blood specimens developed under subsection (7)(a).
(d) That the blood specimens taken for purposes of conducting the tests required under subsection (1) may be used for medical research pursuant to subsection (7)(b).
(9) In addition to the requirements of subsection (1), the health professional described in subsection (1) or the hospital or other facility in which the birth of an infant takes place, or both, may offer to draw an additional blood specimen from the infant. If such an offer is made, it shall must be made to the infant's parent, guardian, or person in loco parentis at the time the blood specimens are drawn for purposes of subsection (1). If the infant's parent, guardian, or person in loco parentis accepts the offer of an additional blood specimen, the blood specimen shall must be preserved in a manner that does not require special storage conditions or techniques, including, but not limited to, lamination. The health professional or hospital or other facility employee making the offer shall explain to the parent, guardian, or person in loco parentis at the time the offer is made that the additional blood specimen can be used for future identification purposes and should be kept in a safe place. The health professional or hospital or other facility making the offer may charge a fee that is not more than the actual cost of obtaining and preserving the additional blood specimen.
Sec. 5431a. (1) By January 1, 2024, the department shall develop a notice on MTHFR to be provided to a parent, guardian, or person in loco parentis of an infant who receives a positive test result for MTHFR under section 5431. The department shall make the notice available to the public and health professionals by posting the notice on its website in a printable format.
(2) The notice required under subsection (1) must be in substantially the following form:
Your infant has tested positive for the MTHFR (methylenetetrahydrofolate reductase) gene mutation and there can be very serious health implications as a result. Please carefully read this information before making any medical decision.
Consider seeking further information beyond what is provided in this notice and delay any nonemergency medical treatment for your infant until fully informed on potential risks of injury or death.
The MTHFR gene mutation will cause your child to be unable to efficiently expel toxins or heavy metals from their body like an average individual without MTHFR. If you introduce synthetic toxins or heavy metals to your infant, you may risk an inflammatory reaction that may lead to damage to the infant's intestinal tract, brain inflammation, or death. The severity of the inflammatory reaction can vary by individual and type of MTHFR gene mutation.
Foods that are synthetic in nature, including, but not limited to, preservatives, artificial food dyes, or added synthetic vitamins, can create gut health issues leading to inflammation and poor absorption of nutrients. If you are considering supplementing breast milk with alternative formulas, review ingredients and consider natural options.
Medical treatments, including, but not limited to, the hepatitis B vaccine, which has synthetic carrier fluid containing aluminum and formaldehyde, can potentially create severe inflammatory responses in an infant with a MTHFR gene mutation. Consider delaying the hepatitis B vaccine to a later visit with your primary care provider. Weigh the risks to your infant of adverse reaction to the vaccine versus the risk of your infant contracting a sexually transmitted infection.
(3) As used in this section, "MTHFR" means a methylenetetrahydrofolate reductase (MTHFR) gene variant.
Enacting section 1. This amendatory act does not take effect unless Senate Bill No.____ or House Bill No.____ (request no. 01756'23) of the 102nd Legislature is enacted into law.
