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U.S. House Committee Holds Hearing on Jaime Herrera Beutler Prenatal Screening Education Bill
Jaime’s solution to address education gaps for parents, health care providers regarding accuracy of widely-used prenatal screenings progresses through Congress
Today, the U.S. House of Representatives Energy & Commerce Health Subcommittee held a hearing on bipartisan legislation introduced by U.S. Representatives Jaime Herrera Beutler (R-WA) and Lucille Roybal-Allard (D-CA) to improve parents’ understanding of the limitations and benefits of prenatal screening provided during pregnancy.
Today, the U.S. House of Representatives Energy & Commerce Health Subcommittee held a hearing on bipartisan legislation introduced by U.S. Representatives Jaime Herrera Beutler (R-WA) and Lucille Roybal-Allard (D-CA) to improve parents’ understanding of the limitations and benefits of prenatal screening provided during pregnancy. The Accurate Education for Prenatal Screenings Act would develop and facilitate broad access to accurate, evidence-based information to accompany cell-free DNA prenatal screenings by requiring the U.S. Department of Health and Human Services to create and maintain two separate education programs for patients and health care providers.
Cell-free DNA prenatal screenings – a new technology available since 2011 – are blood tests that examine placental DNA in the maternal bloodstream to determine whether a baby is at risk for a chromosomal abnormality. These screenings are not diagnostic, since they are not reliable enough to confirm an abnormality. Studies have revealed that screenings can produce false alarms up to 50% of the time.
The hearing brought in experts to help the Health Subcommittee closely examine Jaime’s bill and five other pieces of legislation aiming to improve health care and treatment. Dr. Anthony Gregg, M.D., testified in favor of Jaime’s bill on behalf of the American College of Medical Genetics and Genomics. The hearing is the requisite preliminary step for the Accurate Education for Prenatal Screenings Act to advance through Congress.
“Today’s hearing shows that congressional health care leaders recognize the need to strengthen the information accompanying prenatal screenings. These screenings should not be confused with diagnoses, and it’s critical that parents are receiving the education and counseling to best understand these tests’ value – and their limitations,” said Congresswoman Jaime Herrera Beutler. “I’m grateful to Chairman Joe Pitts of the Health Subcommittee for taking up this bipartisan solution that will benefit and empower expectant parents.”
“ACMG agrees with the goal of H.R. 3441, that it is imperative for clinicians to provide patients with both pre-test and post-test counseling when offering NIPS, in order to avoid any potential patient harm or confusion,” said Anthony Gregg, M.D., on behalf of the American College of Medical Genetics and Genomics (ACMG), during his hearing testimony. “We recognize that with nearly 4 million U.S. births annually, it is imperative that obstetric care providers, including obstetricians, family medicine physicians, nurse midwives and nurse practitioners, have access to accurate educational materials that ensure patients receive accurate pre-test counseling.”
“I commend Energy and Commerce Health Subcommittee Chairman Joe Pitts and Ranking Member Gene Green for including our bill, the Accurate Education for Prenatal Screenings Act, in today’s hearing,” said Congresswoman Roybal-Allard. “Expectant moms deserve to have access to the best information about cell-free DNA prenatal screenings, and our bill will help to ensure that this information is accurate, balanced, and readily available to all families and health providers. I hope that Dr. Anthony Gregg’s strong testimony about the need for the Accurate Education for Prenatal Screenings Act will encourage our colleagues to cosponsor this important legislation, so that we can move the bill forward towards passage.”
Inaccurate up to half of the time: Two recent industry-conducted studies revealed the screenings can have false alarms 50% of the time. In another study, samples from two women who were not pregnant were sent to five testing companies for analysis. Three companies returned samples indicating they came from a woman who was carrying a healthy baby.
Studies show parents receiving inaccurate, inconsistent, incomplete information: One study of information available online about prenatal screenings found that only 15% of screening manufacturers’ websites pointed out that the test cannot rule out all fetal abnormalities. Some websites stated that the test guarantees a healthy baby. Just over half the websites stated that an invasive test is required to confirm a positive non-invasive screening result, and only a quarter mentioned the importance of pre-test counseling with a health care professional even though they are both recommended by medical professional guidelines.
Screenings are not regulated by the FDA: Currently, cell-free DNA prenatal screenings are not regulated by the FDA, and there are no requirements about what information is provided to doctors and parents.