Expanded Genetic Screening Act
A BILL
To amend title XIX of the Social Security Act to provide for coverage under the Medicaid program of non-invasive prenatal genetic screening.
Sec. 2 Medicaid coverage of non-invasive prenatal genetic screening
“(C) non-invasive prenatal genetic screening for pregnant women of all age groups (provided in a facility, a home, or other setting), subject to the informed consent requirement described in subsection (jj);”
“(jj) Informed consent requirement for non-invasive prenatal genetic screening
“(1) In general—For purposes of subsection (a)(3)(C), the informed consent requirement described in this subsection for non-invasive prenatal genetic screening furnished to a pregnant woman is that, prior to furnishing the screening to the woman, the provider of the screening gives the woman a full disclosure that includes, at a minimum, the following information:
“(A) The limitations of the screening platform for any genetic screen or test with the goal to identify risk or diagnose a genetic condition.
“(B) Any potential interferences that may affect the screening's performance.
“(C) Information about predictive values used by the screening based on appropriate matching population and inherent risk factors based on age, family history, and other aneuploidy risk factors (such as ultrasound abnormalities).
“(D) The need for follow-up diagnostic testing to confirm true positive results before decisions are made about irrevocable clinical intervention.
“(2) No medical assistance available for screenings provided without consent—No payment may be made under section 1903(a) with respect to a non-invasive prenatal genetic screening that is furnished to a pregnant woman without meeting the requirement described in paragraph (1).”
“(28) with respect to amounts expended for non-invasive prenatal genetic screening services furnished to a pregnant woman, unless the informed consent requirement of section 1905(jj) is met.”