Due to a court ruling, a state regulation (17 CCR 6523(e)) that required clinical laboratories to have a contract with CDPH to provide prenatal birth defect screening for fetal autosomal trisomies or neural tube defects will no longer be enforced.
Prenatal care providers may now order cfDNA screening for fetal autosomal trisomies and maternal serum alpha-fetoprotein screening (MSAFP) for neural tube defect screening outside of the PNS Program, if desired, from any licensed clinical laboratory.
Prenatal care providers are still required to offer participation in the California Prenatal Screening (PNS) Program to their pregnant patients. For patients who elect to participate in the PNS Program, providers must order prenatal screening tests through the PNS Program from state-contracted labs. Patients who chose not to participate in the PNS Program can be referred to labs testing outside of the program.
The PNS Program continues to provide California residents with high-quality screening for Down syndrome (trisomy 21), trisomy 18, and trisomy 13 using cell-free DNA, and neural tube defect screening using MSAFP, for low program fees that are reimbursed by Medi-Cal and most California health insurance plans, with no cost sharing (copayment, coinsurance, or deductible).
Only patients who participate in the California Prenatal Screening (PNS) Program will have access to free follow-up genetic counseling and diagnostic services at a state-contracted Prenatal Diagnosis Centers for a pregnancy determined to be high-risk.