Important changes to prenatal testing authorizations


This letter is to inform you about major changes to the California Prenatal Screening (PNS) Program that will impact the way you provide prenatal screening services to pregnant individuals in California.

Effective September 19, 2022, providers should order both the circulating free DNA (cfDNA) and maternal serum alpha fetoprotein (MSAFP) screening tests using the CalGenetic Portal through the California Department of Public Health (CDPH).

These requests need to go through the CalGenetic portal and not through the Alliance authorization processes. As of Sept. 19, the Alliance does not authorize these tests and will void them as a duplication of service that is available through CDPH.

After a screening order is electronically submitted on the CalGenetic Portal, providers will need to print a PNS Program Consent and Order Confirmation for each cfDNA and MSAFP screen, respectively. The Consent and Order Confirmation will need to be printed on PNS Program label stationery, which can be ordered now at no cost on the PNS Program supplies order webpage.

The PNS Program label stationery contains four unique peel-off barcode number labels that should be affixed to the required sample collection tubes and to the required paperwork for cfDNA screening and MSAFP screening orders.

The PNS Program invoices the $232 PNS Program fee for the cfDNA screening or the $85 PNS program fee for MSAFP screening to the patient’s insurance company. As is currently the case, providers do not need to do any billing.

Requirements will continue for providers to offer prenatal screening to patients.

Title 17 of the California Code of Regulations (CCR), section 6527 refers to clinician requirements, which provide that prenatal care providers must provide information regarding the PNS Program to pregnant individuals. These individuals must then consent to participate in the PNS Program to receive prenatal screening for autosomal trisomies and/or neural tube defects.

CCR section 6523 provides that only California Department of Public Health (CDPH) approved prenatal screening laboratories should offer prenatal screening for birth defects that are included in the department’s PNS Program to California residents.

Currently, the state has contracted with three cfDNA laboratories: Natera, Quest Diagnostics, and PerkinElmer.

Since the revised PNS Program has exclusivity in California to screen for trisomies 21, 18 and 13, as well as maternal serum AFP for neural tube defects, no other labs operating in California may screen for trisomies 21, 18 and 13 using cfDNA methodologies. Consequently, providers may only order what is on the revised PNS Program screening panel from the state-contracted labs.

For more information, please read this CDPH letter to prenatal care providers.