PREEMPT Act

This Act may be cited as the “Preeclampsia Risk Evaluation and Evidence-based Management through Personalized Testing Act” or the “PREEMPT Act”.

Congress finds the following:

(1) According to the Centers for Disease Control and Prevention, preeclampsia affects approximately 5 to 8 percent of pregnancies globally, with 70,000 maternal deaths and 500,000 fetal deaths each year in the United States.

(2) In the United States, Black women are at least three times more likely to die due to a pregnancy-related cause when compared to White women.

(3) Preeclampsia and related cardiovascular and hypertensive disorders of pregnancy are one of the leading causes of maternal mortality and morbidity in the United States, contributing to up to 15 percent of all maternal deaths, particularly in States with the highest-risk populations and in low resource settings.

(4) Preeclampsia is a major contributor to preterm births, accounting for about 15 to 20 percent of all preterm deliveries in the United States.

(5) The annual economic burden of preeclampsia in the United States exceeds $2 billion, including both direct health care costs to mother and baby, and indirect losses due to long-term health complications and lost productivity.

(6) Risk factors for preeclampsia include maternal age, pre-existing diabetes, pregnancies with multiples, chronic hypertension, obesity, multiple pregnancies, and certain autoimmune diseases, all of which can increase the likelihood of developing this condition.

(7) Women who develop preeclampsia during pregnancy have an elevated risk of long-term cardiovascular complications, including chronic hypertension, heart disease and stroke.

Title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) is amended by inserting after section 1948 the following new section:

“1949. Guidance and technical assistance with respect to coverage of preeclampsia screening and detection tests.—

(a) Guidance.— Not later than the date that is 180 days after the date of the enactment of this section, the Secretary shall issue guidance to States and, as appropriate, medicaid managed care organizations, on—

(1) best practices for improving outcomes for pregnant women with preeclampsia who are eligible for and receiving medical assistance under a State plan (or waiver of such plan) under this title or a State child health plan (or waiver of such plan) under title XXI through early screening, detection, and management; and

(2) which tests for the early detection of preeclampsia may be furnished to such pregnant women as medical assistance under such a State plan (or waiver) or such a State child health plan (or waiver), including whether the biomarker tests described in subsection (c) may be so furnished.

(b) Technical assistance.—

(1) In general.— The Secretary shall, not later than 30 days after receipt of a request from a State for technical assistance with respect to determining whether a State plan or State child health plan may provide medical assistance for a specific test for the early detection of preeclampsia, including a biomarker test described in subsection (c), provide such technical assistance to such State.

(2) Rule of construction.— Nothing in this subsection shall be construed as creating a requirement for a State to request or receive the technical assistance described in paragraph (1) as a condition of providing medical assistance for a specific test for the early detection of preeclampsia, or of receiving Federal financial participation for such medical assistance.

(c) Biomarker tests To be considered.— For purposes of this section, the Secretary shall consider advanced biomarker tests for the early detection of preeclampsia, including any such test that is regulated and cleared under the Federal Food, Drug, and Cosmetic Act as a device (as defined in section 201(h) of such Act), and any such laboratory-developed testing service furnished by a clinical laboratory that is certified under section 353 of the Public Health Service Act to perform high-complexity testing.”.