DoD: counseling needed for Down syndrome prenatal testing

On Monday, Veterans Day, I featured the prenatal testing guidelines for the Department of Defense (DoD) and Veterans Administration (VA). Those guidelines make clear the need for patient counseling when offering prenatal testing for Down syndrome and other genetic conditions.

This year, with the roll-out of non-invasive prenatal screening (NIPS), professional societies have revised their guidelines for prenatal testing. I detailed the International Society for Prenatal Diagnosis‘ (ISPD) revised protocol, and highlighted how the American College of Medical Genetics and Genomics (ACMG) and the National Society for Genetics Counselors (NSGC) each called for pre- and post-test counseling. The call for pre-test counseling was a notable recognition by the professional organizations of the need to address personal values and understanding about the various forms of prenatal testing (conventional screening vs. NIPS vs. diagnostic testing). Turns out, the DoD/VA guidelines had led the way on this need with their guidelines originally issued in 2009.

The table above is from Appendix 3 of the DoD/VA guidelines. It shares in common the ISPD’s protocols of what type of testing to offer at what time during a pregnancy. But, it emphasizes the need for counseling at the initial visit, detailed counseling on the eve of when prenatal genetic testing can be performed, and then post-test and late entry counseling as the pregnancy progresses and testing is accepted and results returned.

From the guidelines themselves some key quotes:

• In order for a woman to come to an informed decision about which method of testing, if any, to undergo, she must be carefully counseled.

I was going to bold certain phrases in that one line, but then most of the statement would have been bolded for emphasis because so much is packed into that one sentence:

• “for a woman to come to an informed decision”: emphasizing that ultimately all decisions about prenatal testing should be made by the woman and should be informed decisions
• “which method of testing, if any”: noting an option not mentioned by NIPS labs in their marketing materials, but necessary for any independent informed decision: the option of NOT having testing.
• “carefully counseled”: not summarily counseled; not counseled so the practitioner can check the box “counseled;” but, “carefully counseled.” The guidelines go on to explain why this care is needed:

Because of the complexity and changing nature of the currently available testing, extensive counseling is required to clarify the nature of the testing and allow appropriate informed consent.

To address this complexity, the DoD/Va recommend an initial brief counseling session that provides summary information for women to begin considering whether to undergo testing. Then, a comprehensive counseling session should occur prior to accepting prenatal testing. This comprehensive session should include:

• information regarding the elective nature of the testing, i.e. that women can decline testing
• the various available screening strategies
• the potential benefits and limitations of screening tests
• the potential risks and benefits of diagnostic testing
• the locally available diagnostic testing strategies (since not all locations provide CVS or other diagnostic testing); and,
• the financial and institutional limitations of pregnancy termination in the DoD/VA.

In the on-line update to the guidelines, it is further made clear that each institution providing prenatal care should provide or arrange for access to genetic counseling.

As mentioned in Monday’s post, these guidelines issued by a Federal agency should further inform coverage for prenatal testing. Genetic counseling remains a service that is inconsistently covered as part of maternity care. Given that the DoD/VA recognize the need for genetic counseling for armed service members and veterans, this further makes the case for why private insurance should also cover genetic counseling for prenatal testing.