By Chantelle Schenning
What we’re watching: Emergency DPH-21-008E Prenatal Screening Regulations
On September 19th, 2022, these Regulations went into effect without a comment period or opportunity for stakeholder engagement and now apply to all Californians regardless of insurance type. While the intent of expanding access to noninvasive prenatal screening (NIPS) is good, the Prenatal Screening Program (Program) added a pared down version of the screening while also created additional restrictions to access and burdens to clinicians by:
- Limiting the information an OB/GYN can order for their patient within the Program
- Providers ordering NIPS via CPDH’s Prenatal Screening Program will only receive information for ~ ⅓ of the standard screening utilized currently outside of the program. See Table 1 below.
- The NIPS does not meet American College of Obstetrics and Gynecology guidelines (see ACOG letter) which raises liability concerns.
- Imposing a homegrown portal, workflow, and equipment requirement on providers to participate in the mandated program
- Effective September 19, clinicians must use the CDPH portal to order NIPS for any Californian. The CDPH workflow requires use of special labels for the test tubes as well. If a clinician decides not to use the portal, they may order via paper order form and will only receive the results via paper (i.e. postal mail or fax).
- Prohibiting clinicians and healthcare organizations from accessing the same screening (i.e, autosomal trisomies) outside of the Program
- Most clinicians have existing workflows with laboratories to provide this prenatal screening service to their patients. Effective September 19th, all clinician workflows should have changed to accomodate CDPH’s new process. If clinicians want to order a screening for the missing information (e.g. sex chromosome aneuploidies) that is not included in the CDPH program, clinicians will need to place a second order for the remainder of the screening, and the patients will be billed separately.
Who should pay attention?
Everyone involved in delivering obstetrics and prenatal care to pregnant individuals in California, especially clinicians and healthcare leaders. The program exempts Kaiser Permanente, who is allowed to provide these services within their closed system.
The Program will annually miss at least 1,263 Californian pregnancies impacted by these genetic variations and will not enable patients or their providers to plan their care most effectively. (Calculation based on March of Dimes data for 2020 data on the number of births and fetal mortality rate in California.)
In addition to the significant, mandated changes to clinician workflows and the Program creating liabilities by offering a screening below ACOG guidelines, there is great concern this regulation and program could exacerbate health inequities. The Healthy African American Families published an article in the LA Sentinel stating,
“Black or Hispanic underserved communities will be relegated to the more basic screening offered by CDPH and will have more babies born with these conditions without access to the critical information that may have led to earlier intervention to improve outcomes. By imposing a single test offering with no flexibility to add additional conditions within the program, and no ability to opt out of the program, CDPH will likely end up further exacerbating healthcare disparities, where the have’s and have not’s experience two very different standards of care.”
Patients and providers deserve to have timely comprehensive information to make informed decisions about care planning. By mandating the limited screening through the Program, it also limits reproductive rights, choices, and access to services.
How to Take Action and Learn More?
The California Department of Public Health is hosting a Public Hearing on October 26, 2022, more than a month after the Program went into effect. Please review the Regulation and the Program, and let the Department know how this will impact your ability to deliver care to pregnant individuals in California. Additionally, please consider adding your name and/or organization’s name to this sign on opportunity, which will be shared with the Department.
Table 1. Information available from NIPS before the Program, within the Program, and outside of the Program.
|Available Information from Non-Invasive Prenatal Screening (NIPS)||NIPS Options Currently Available in CA|
Prior to Program
|NIPS Exclusively within the |
CDPH PNS Program
|NIPS Ordering Available |
Outside of the CDPH PNS Program
|Patau Syndrome (Tri 13)|
|Edward’s Syndrome (Tri 18)|
|Down Syndrome (Tri 21)|
|Sex Chromosome Aneuploidies||Yes||No||Yes|
|Turner Syndrome (45,X)|
|Klinefelter Syndrome (47,XXX)|
|Jacobs Syndrome (47,XYY)|
|XXX Syndrome (47,XXX)|
|1p36 Deletion Syndrome|
|Wolf-Hirschhorn (4p16.3 Del)|
|Cri-du-Chat (5p15.2 Del)|
|Prader-Willi/Angelman Syndromes (15q11.2q13 Del)|
|DiGeorge Syndrome (22q11.2 Del)|
Disclaimer: Chantelle Schenning is an employee of a diagnostic laboratory that provides NIPS.