Public Health Committee

JOINT FAVORABLE REPORT

Bill No.:

HB-5147

Title:

AN ACT CONCERNING NEWBORN SCREENING FOR GLOBOID CELL LEUKODYSTROPHY AND CYTOMEGALOVIRUS AND ESTABLISHING A PUBLIC EDUCATION PROGRAM FOR CYTOMEGALOVIRUS.

Vote Date:

3/25/2014

Vote Action:

Joint Favorable Substitute

PH Date:

2/28/2014

File No.:

SPONSORS OF BILL:

Public Health Committee

REASONS FOR BILL:

The bill adds cytomegalovirus to the list of required newborn screening tests infants who fail a newborn hearing test, beginning January 1, 2015.

The bill also requires the DPH commissioner to establish an education program to inform pregnant women, and women who may become pregnant, about cytomegalovirus. It requires information to be made available to day care centers, group day care home, health care providers who provide services to pregnant women and infants, school nurses and others providing health education in schools, and other organizations providing services to children in a group setting. The bill requires the person in charge of an institution that administers a newborn screening test for cytomegalovirus to provide parents with information regarding cytomegalovirus.

RESPONSE FROM ADMINISTRATION/AGENCY:

Jewel Mullen, MD, Commissioner, Department of Public Health: The bill would require that any baby who fails a newborn hearing test be screened for cytomegalovirus (CMV), but we believe the legislative intent is that this screening be a hospital mandate and would occur in the clinical setting. The Public Health Laboratory only receives blood spots for newborn screening, not urine or saliva which are standard for testing for CMV.

Krabbe disease is a genetic disorder caused by an enzyme deficiency which affects the nervous system development. Symptom onset usually appears before one year of age and includes muscular weakness, feeding difficulties, vision loss, seizures, and slowed mental and physical development.

The Secretary of The Department of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children was petitioned to include Krabbe disease in the recommended uniform screening panel. Following careful review of available evidence, the Committee concluded that while there could be a benefit from early identification and intervention, substantial harm is also possible from testing/identification, treatment/other intervention or both. The Committee determined not to recommend adding the condition to the recommendation panel, citing significant gaps in evidence that must be addressed before further discussion of its inclusion. Treatment requires stem cell transplantation and carries significant risks.

A very small minority of states are offering Krabbe testing within the newborn panel. The experience has shown problematic for reasons including the high volume of false negative results that require further testing and significant increase in the cost of screening, tracking and follow-up testing. The situation is further complicated by the identification of infants with mutations of unknown clinical significance.

Should this screening be mandated, the responsibility could not be conducted without additional resources for instrumentation, reagents, and staff for the Public Health Laboratory.

NATURE AND SOURCES OF SUPPORT:

Farah Armstrong: Strongly supports HB 5147 advocating for CMV awareness and education for all pregnant women and CMV testing and treatment for newborns. She had never heard of congenital cytomegalovirus (CMV) until her daughter was born and the neonatologist informed her of the diagnosis. The infant went through 10 days of testing, platelet transfusions, hearing screening, vision exams, MRI's and many other procedures before she was released to go home on hospice care.

A similar CMV education bill was passed into law in Utah in 2013.

The following list of names is family or friends of Farah Armstrong and submitted testimony in support of HB 5147.

Jason Ellis, Vera Lam, Jennifer Vardeman-Winter, Rachel Noon, Casey Robert Yaw, Dyamon Jones,Christi Vogl, Bill Price, Karissa H. Mithani, Akhlaque Ahmed, Libsen Castillo, Tim Hughes, Michelle Anderson, Oris C. Hernandez, Sindhu Veettil, Mary, Judi Klein, Mohammad Ghazi, Askay Mohikar, Amy Zoch, Doug Blalock, John Fassero, Kate Ghazi, Lou Anne Dulaney, Marie Vielma,Sandra Stone, Yordanka Fassero, Fern Richie, Jean Lorton, Lindsey Callegari, Charliene Berarm, Megan Whittemore, Phillip Armstrong, Randy Klein, Reca Oliver, Evan Ghazi, Daniel Zoch, Greg Martin, Laura Quinn, Christine Faulkner, Anne Whitney-Obousy MD, Christina Mitchell, Heather Guerrero, Jane Stewart, Patty Roe, Ann Blalock, and Judy Adams

Lisa Saunders, parent representative, Congenital CMV (Cytomegalovirus) Foundation: Submitted testimony in support of HB 5147 and shared the story of her daughter who struggled with CMV. She notes that her OB/GYN never provided her with information about CMV and the risk factors that increase the likelihood of her unborn child getting the infection. She did not know that women who work in daycare, or have young children in daycare are at higher risk for catching CMV as preschoolers are the majority of carriers. Mothers should not kiss their toddlers around the mouth or share food with them. She shared that she not only had a toddler when she was pregnant with her second child but also ran a licensed daycare center out of her home. The Congenital CMV Foundation works to raise awareness about maternal testing for first infection during pregnancy, newborn testing and the need to develop a vaccine.

Christine Jost and Grace Cleere: Supports HB 5147 and submitted testimony supporting their friend Lisa Saunders.

Richard W. Avazian, Stephanie Bolstridge, Becca Mitchell, Dawn LeBoeuf, Donna White, Neal and Sandra Salerno, Christie Slaughter, Sara Doutre, Amanda Dawson, Casey Famigletti, Michelle Murillo, Casey Famigletti, Kendra Matter, and Nichristin Guesman: Parents and relatives of children with cytomegalovirus submitted testimony sharing their personal stories and expressed support for HB 5147. They questioned why OB/GYN physicians did not provide them the necessary information with precautions to prevent CMV, although precautionary information are given about not eating soft cheeses and deli meats (to prevent listeria), not to clean cats litter boxes (to prevent toxoplasmosis), to avoid alcohol consumption (to prevent fetal alcohol syndrome) and pregnant women are advised to take adequate amounts of folic acid to prevent spinal bifida.

HB 5147 will amend the Connecticut Health code and direct the Department of Public Health to establish a public education awareness program regarding the dangers of congenital CMV and the methods of prevention of CMV. This bill would also direct medical practitioners to test infants for CMV and provide the parents of those infants information about the possibilities that congenital CMV can cause as well as my appropriate interventions.

Cindy Barry, Public Health Educator: Firmly believes that education and screening would support women and protect their babies from cytomegalovirus (CMV), a preventable disease, which causes more disabilities than Down Syndrome. CMV is a major cause of morbidity and occasional mortality in newborn infants, yet there is no education campaign to warn expectant parents. CMV frequently leads to mental retardation and developmental disabilities.

Passage of HB 5147 would ensure that all people would have access to accurate information about CMV, that the high cost of medical care and special educational services are reduced, and that a sustainable policy change is created to protect future generations.

Stanley A. Plotkin, MD, Consultant in Vaccinology: Women who are informed about congenital cytomegalovirus (CMV) can take the necessary steps to avoid infection during pregnancy, particularly through hygienic measures when they come into contact with young children, the primary carriers for the virus.

Hearing tests of normal and abnormal newborns would identify those children in need of follow-up. Once the children are identified, proper treatment can begin early on and can prevent the spread of the disease.

Someday it may be possible to prevent CMV by vaccination, but until that time, screening is the best way to reduce the impact of CMV.

Janelle Greenlee, President and Founder, Stop CMV: So many times crucial CMV prevention information doesn't make its way to those who need it most, pregnant women at risk of acquiring cytomegalovirus from bodily fluids of babies, toddlers, and small children.

Stuart P. Adler, MD, Department of Microbiology and Immunology, Virginia Commonwealth University: This bill directs medical practitioners to test infants that shows signs of hearing loss for cytomegalovirus and inform the parents of those affected about possible birth defects and any appropriate interventions. The hearing aspect of the bill is important because hearing deficit is common after a CMV infection before birth.

Eugene D. Shapiro, MD, Professor of Pediatrics, Epidemiology and Investigative Medicine at Yale University: Provided testimony in support of HB 5147. Section 1 would ensure newborn screening for several important newborn illnesses that are amenable to early treatment and interventions, including but not limited to cytomegalovirus (CMV) in any newborn infant who fails a newborn hearing screening.

Section 2 would establish a public education program to inform pregnant women and women who may become pregnant, about a common virus called CMV which is the leading cause of birth defects and deafness. It would also provide for an education program about testing and treating newborns diagnosed with congenital CMV.

Cytomegalovirus is the most common cause of hearing loss and neurodevelopmental disabilities in this country. Clinical trials have shown that preventative measures for pregnant women and treatment measures for CMV infected newborns are beneficial.

Rebecca Mitchell Ghazi: Submitted similar testimony in support of HB 5147.

Gail J. Demmler Harrison, MD, Department of Pediatrics, Section of Infectious Diseases, Baylor College of Medicine: This bill supports programs for education in cytomegalovirus (CMV) awareness and valuable knowledge about simple hygienic precautions that may save the life and wellbeing of an unborn child by preventing them from being infected with the CMV virus. The bill would provide testing for newborns for congenital CMV who fails hearing screenings or otherwise have CMV symptoms at birth that may require treatment. Treatment in randomized clinical trials has shown to be beneficial and is now easily available orally and covered by medical insurance policies.

Jenny Meeden Bailey: She expressed support of this bill. She shared her personal story about her second child being diagnosed with cytomegalovirus (CMV). My daughter has required cochlear implant surgery on her left side to increase her hearing. Early Intervention during the pregnancy and early in her daughter's life has spared her daughter from other severe and painful conditions.

She believes that if she had received proper counseling early in her pregnancy, she could have taken simple precautions that would have prevented contracting the CMV infection.

Bobbie Jo Howard, Len and Lorraine Rego, Linda Cato, Shirley Clement, Herman and Anna Schiffli, Lizanne Sivapalan, Stacie Cole, Kathleen M. Mouldon, Sharon Schmidtbauer, Anneke DeLuycker, and Wendy Whitney: All submitted testimony in support for the bill.

NATURE AND SOURCES OF OPPOSITION:

None

Reported by: Lori Littmann

Date: 3/31/2014