Opinion: California’s New Prenatal Screening Program A Step Back In Care

A pregnant woman looks at ultrasound images. Courtesy of NIH

As an obstetrician / gynecologist, my north star has always been to ensure that all women, regardless of race, ethnicity or socioeconomic level, receive the best possible clinical care. Unfortunately, too many pregnant women still face insufficient access to the best prenatal health care options.

Recently, the California Department of Health announced plans to expand access to cell-free DNA testing, or cfDNA, which is the most accurate prenatal screening for genetic chromosomal abnormalities, through its prenatal screening program.

While I certainly support increased patient access to cfDNA testing, I am disappointed that the proposed state program updates place significant burdens and restrictions on healthcare providers and will in fact lower – not elevate – the standard of care for California mothers.

My patients rely on me and their providers as a personal and trusted advisor for medical advice throughout their pregnancy. This new program does not take into account clinical experience or decision making. Instead, it restricts my ability to provide patients with all of the appropriate prenatal screenings that they need.

Scheduled to come into effect in July 2022, the amended program limits the conditions sought in cfDNA tests to only trisomies 21 (Down syndrome), 18 (Edwards syndrome) and 13 (Patau syndrome).

The technology of prenatal ultrasound and genomic screening have made significant advancements, especially over the past decade. In fact, as a specialist in maternal and fetal medicine, it is difficult to keep up with the latest technologies offering non-invasive prenatal screening.

Today, I regularly order cfDNA tests for my patients which include screening for a wider range of conditions, including sex chromosome abnormalities such as monosomy X and microdeletion syndromes.

For example, I order a cfDNA test that includes screening for 22q11.2 (SD) deletion syndrome, the most common microdeletion syndrome, for which early detection and interventions can have a profound impact on the results for the child (for example, a baby with 22q that is not delivered to a tertiary facility may face untreated heart problems or hypocalcemia problems, which can lead to intellectual decline). This important condition is not currently included in the proposed state program.

The medical industry is grappling with a significant shortage of healthcare workers. To screen my patients for these additional conditions, the California Department of Health will require that I go through an entirely new – and frankly unnecessary – process of paperwork and forms, and even collect a separate blood sample from the same patient.

These barriers will force me and my team to do double the work if we hope to maintain the same level of care that we provide to our patients today, creating inefficiencies and ultimately increasing healthcare costs. It is a step backwards.

The new screening program will also increase disparities in access to more comprehensive cfDNA screening options, particularly among some of California’s most underserved communities – an issue that particularly excites me. If these changes are implemented, patients will have to pay out of pocket to be screened for these additional critical conditions.

Only patients who can afford to pay will be able to access this higher level of care. In addition, only the best-resourced medical practices will have the resources to handle the extra workload.

I have spent my entire career working to provide women with and advocate for access to the best options for maternal and prenatal care. And now I call on our leaders, lawmakers and community members to pause this agenda and reassess its impact. Our patients deserve better.

California policymakers must engage with healthcare providers closest to patients everyday before implementing programs that will have such sweeping consequences. This includes the prenatal screening program.

Let’s work together to make sure we don’t lower the quality of care for mothers and babies in California.

Dr Sean Daneshmand, MD, is a San Diego-based OB-GYN who specializes in Maternal and Fetal Medicine. He is also the founder of Miracle Babies, a nonprofit organization dedicated to supporting mothers and families of infants born prematurely or with conditions that require them to remain hospitalized after birth.







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