During the 2015 state legislative sessions, lawmakers again delved into the contentious issue of cytomegalovirus (CMV) screening for newborns who fail an infant hearing test.
Four states introduced bills that initially focused on mandated screening for CMV in these infants and were modeled after a Utah law that took effect in 2013. No evidence, however, supports treatment of newborns who test positive for CMV but are otherwise asymptomatic. In addition, treatment currently is limited to off-label use of the antiviral drug valganciclovir, which carries potential risks.
In response to concerns by AAP chapters and others within the physician community, state legislators amended provisions that would have created screening and treatment requirements that are not evidence-based.
“Unfortunately, when legislatures try to fix practice standards into law, the law tends not to keep up with scientific changes,” said William M. McDonnell, M.D., J.D., FAAP, who lived in Utah when the CMV legislation was enacted and is chair of the AAP Committee on Medical Liability and Risk Management. “Clinicians practicing in the best, most up-to-date fashion may then face increased medical malpractice liability risk. If states continue down this path, it may threaten our ability to practice medicine in a manner consistent with the best available science.”
In their response to the proposed legislation, AAP chapters sought to balance the concerns of families about infant hearing loss and the need to ensure evidence-based practices — which do not support screening of newborns for CMV who fail an infant hearing test but are otherwise asymptomatic — are reflected in state law.
Ultimately, Connecticut, Hawaii, Illinois and Texas enacted legislation this year requiring their state departments of public health to educate the public on how to prevent the transmission of CMV. A similar bill introduced in Tennessee was not enacted.
Connecticut’s law also mandates CMV screening “as medically appropriate” following a failed newborn hearing screening but does not require counseling or treatment.
AAP Red Book Editor David W. Kimberlin, M.D., FAAP, noted that there are no definitive data showing that treatment helps this minimally symptomatic group.
“With no proof of benefit and with the potential for harm from antiviral treatment, we should be very careful in considering universal treatment of these babies,” said Dr. Kimberlin, an ex officio member of the AAP Committee on Infectious Diseases. “These kinds of laws may indirectly result in or drive such treatment, though, because we all know that when a baby is identified through the law’s mandated screening following a failed hearing test, then the parents and doctor often will feel they must ‘do something.’ In doing so, we could be hurting the very children we are trying to help.”
Texas Pediatric Society Advocacy and Health Policy Coordinator Clayton Travis, M.S.S.W., was engaged in legislative negotiations on the bill in his state.
“Our chapter really wanted to find a way to help families and elevate awareness of CMV, while at the same time ensuring that we’re not legislating the practice of medicine,” Travis said. “That’s why we’re supportive of the District VII resolution passed at this year’s Annual Leadership Forum urging the Academy to author a policy statement on the prevention of congenital CMV, and that the Academy incorporate information on preventing congenital CMV into publications aimed at educating pregnant women and pediatricians.”Dr. Edwards
Anne R. Edwards, M.D., FAAP, chair of the AAP Committee on State Government Affairs cautions, “I think it’s important to ask legislators considering similar kinds of legislative mandates on clinical practice, ‘What is the scientific evidence that supports this mandate?’ The narratives of parents advocating for their children are truly compelling — CMV is a terrible disease. But codifying diagnosis and treatment modalities into state law is fraught with peril and may ultimately lead to worse outcomes for kids that need our help the most.”
For more information on cytomegalovirus screening and related advocacy resources, contact Ian Van Dinther in the AAP Division of State Government Affairs, at 800-433-9016, ext. 7092, or firstname.lastname@example.org