German Government Discusses Noninvasive Prenatal Testing

Should the practice of noninvasive prenatal testing (NIPT) change? The health committee of the German Bundesrat placed the subject on the agenda for its May 31 parliamentary session.

Fetal blood screening for trisomy 13, 18, and 21 has been covered by health insurance in Germany since June 2022 under certain conditions. In the third quarter of 2022, the test was invoiced more than 50,000 times, according to the most recent figures from the National Association of Statutory Health Insurance Funds. The test can only be performed if the physician and expecting mother mutually agree after discussing the procedure together. However, among the critics’ worries is that physicians are not giving unbiased advice.

The Senate of Bremen sees the current arrangement as inadequate and is using a proposed resolution to demand common regulations for NIPT from the Bundesrat. The basis of the Senate’s initiative is also that the testing is allegedly unsafe. According to them, the test often comes back with a false positive, especially in young mothers.

The result can be checked by performing an amniocentesis. However, this test entails an additional risk for the pregnant woman. Aside from this risk, the Senate writes in its justification that there is also the danger that the parents-to-be will take the test result for certain and in the event of a positive result, rashly decide to terminate the pregnancy.

In contrast, should the test result be negative, many women will rely on this fact to mean that their child will enter the world healthy. Mothers will therefore refrain from first-trimester screening, despite this screening providing much more accurate results than NIPT. The consequence of this could be more and more (very strenuous) late terminations, since abnormalities are not detected until much later.

Interdisciplinary Expert Panel

The Bremen government proposes analyzing medical-advice data for the test and “implementing an interdisciplinary panel of experts who can review the legal, ethical, and health policy bases for the health insurance companies’ authorization of NIPT,” as it says in the Bremen application.

A closer look at the practical side of things is worthwhile. This is because in countries in which NIPT has long been covered by health insurance, fewer and fewer children with trisomy 21 are being born. The Senate of Bremen is anxious about the same thing happening in Germany. “In the long term (through health insurance coverage of NIPT), this could increase the stigmatization of families of children with trisomy 21 and reduce the amount of support available to children with trisomy 21,” said the Senate. “As a result of the corresponding social developments, the opportunity for expecting mothers and their relatives to decide to have a child with trisomy 21 will decrease.”

Clear Indication Needed

In the meantime, prenatal physicians want a clear indication for the test, said the Dorsten-based prenatal physician Thomas von Ostrowski, MD, of the Professional Association of Registered Prenatal Physicians. When should physicians comply with their patients’ wishes and authorize the test, and when should they not? According to von Ostrowski, because this issue is so unclear, physicians are potentially authorizing the test more easily to protect themselves from legal consequences.

In addition, the physicians also can bill four short discussions of 5 minutes each for the consultation. Therefore, 20 minutes are allocated for a massive life choice. “This scope is not enough,” said von Ostrowski. The woman must have enough time to reach a decision.

Giovanni Maio, MD, PhD, a Freiburg-based expert in medical ethics, described the Senate of Bremen’s initiative as understandable and worthy of support. “The consultation is especially important for NIPT, because it is the only way to be sure that the expecting mother has come to the decision freely and independently, and not just as a result of internalized social expectations,” Maio told Medscape Medical News.

At the same time, Maio warned against “social expectation” creeping into practice, “since there is a serious danger that NIPT could eventually develop into a screening examination, and that would be an enormous step backwards,” said Maio.

Should the test become a part of the screening process in prenatal diagnostics, “it would have massive effects — not just on the parents concerned, but also from a social perspective, which should be taken into account properly in advance,” Maio said.

“It stands to reason that this form of screening will be extended to include other disabilities or impairments, and, as a result, the identity and role of medicine will be affected. Why does the field of medicine exist? Is its aim to systematically weed out disabled life?” If the test were “routinely performed in advance,” this would amount to a systematic negative assessment of disabled life.

However, it is still the role of medicine “to help the pregnant woman or the expecting parents to come to a well-considered and above all independent decision,” said Maio.

“The consultation must therefore be unbiased and have the aim of enabling the pregnant women to come to a decision that is not based on an internalized social expectation, but rather on their own concept of life, so that they can deal with the decision they make for the rest of their lives.”

Question for Society

In light of the high rates of termination that may be expected, affected associations are also speaking up. Sarah Manteufel of the NoNIPT initiative fears that a test including a medical discussion that is covered by health insurance “is gaining momentum toward purely medical aspects of potential trisomy 21,” as she told Medscape.

“If the test goes on to show evidence of a genetic variation, the parents first plunge into a deep chasm because they also only see the findings from a medical perspective, as a problem that should be avoided. Termination is then considered. Instead of this, a discussion should also be had before the possible test about how we actually deal with disability in our society and how we should deal with it.”

In Manteufel’s opinion, the problem cannot “be solved in the waiting room, and not by the pregnant women.” In the end, it is a matter of how families with disabled children are supported socially “so that everyone can have a good life,” says Manteufel.

This article was translated from Medscape’s German edition.

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