Update: cCMV Nomination for the Recommended Uniform Screening Panel (RUSP)

Update: cCMV Nomination for the Recommended Uniform Screening Panel (RUSP)

Greetings National CMV Foundation community and supporters! I am pleased to provide an update about our nomination for congenital CMV (cCMV) for inclusion on the Recommended Uniform Screening Panel (RUSP) by the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). 
As background, in early October of last year the Foundation workgroup re-submitted the nomination package for cCMV to be considered for the RUSP, which is a list of conditions that a national group of newborn screening experts recommend all babies be screened for at birth. It is up to each state whether to follow these recommendations. Getting a particular condition added to the RUSP isn’t easy. Submitting a nomination package is a long process which includes gathering and reviewing evidence and compiling it into a document to make the case for every baby to be screened for the condition. The final document can be dozens of pages long and can take hundreds of hours to craft. To learn more about the process, check out the ACHDNC website. The process is nuanced, and very thorough to make sure that the potential benefits of adding a condition to newborn screening outweigh any potential risks. 
After two rounds of revisions, which entailed providing the committee with a bit more data and clarifying some points, the workgroup and I received a letter from the Chairperson. Unfortunately, the ACHDNC Nomination and Prioritization Workgroup found that there was “insufficient information” to move the nomination forward in the process.  This means that our nomination for cCMV did not make it to the next step towards being added to the RUSP. The letter is publicly available here. The committee noted that information was lacking in some areas, specifically about diagnosis, treatment, and outcomes of infants identified with cCMV by newborn screening. We will be meeting with the chairperson in the upcoming weeks to get a better sense of what additional information is needed. My sense is that this specific information may not exist in the published research at this point, not that it was overlooked or left out of the package. 

Although this feels like a setback in many ways, it provides us an opportunity to strengthen the nomination package for re-submission, and to think collectively about the sort of data that the ACHDNC might want to see when our next re-submission makes it into full evidence review. For example, we need to update the clinical guidelines for caring for infants with cCMV. When these guidelines are updated, we can be sure to specify recommendations around newborn screening, and longer term support of children and families with cCMV.  We can also make a stronger case for cCMV treatment beyond antivirals alone, as antivirals may not benefit many children.  We will also surely learn from larger pilot studies about how best to support infants and families affected by cCMV, and how to connect them with the care and resources needed. The optimist in me feels that this “set back” may make future universal screening programs stronger once cCMV is added to the RUSP. These are bigger picture discussions that we will be engaging in over the coming months as we re-group and strategize about next steps. 

It is important to keep in mind that state-level policy change is occurring rapidly. This is because of our amazing parent advocates, who never give up and are truly making a difference. 

We have had a record-breaking year with 3 states having passed cCMV newborn screening legislation, and at least one state that will be considering universal congenital CMV screening legislation in the upcoming session. Minnesota will be rolling out their pioneering statewide universal screening program in early 2023. We are making progress and will continue to tackle cCMV screening on multiple fronts.  

In closing, I want to thank our National CMV Foundation community for your support and continued work to move the field of cCMV screening forward. Our volunteers, Community Alliance Chairs, staff, CMV families, clinicians, and researchers (you name it) have all been working tirelessly to change the system so that babies with cCMV aren’t missed at birth. And guess what? Change is happening!  Because of your efforts more and more infants are being diagnosed and given the chance to meet their full potential in the face of this terrible virus. We need to keep our momentum going to make sure all babies are screened for cCMV and that we are doing so in the best way possible.  
 I look forward to sending updates about our ongoing progress.

Megan Pesch, MD, MS, FAAP, President-Elect 
National CMV Foundation