AS ONE DOOR CLOSED, ANOTHER DOOR OPENED: THE CONGENITAL CMV INITIATIVE

IN CONNECTICUT

BRENDA KINSELLA BALCH, M.D.AAP CONNECTICUT CHAPTER CHAMPION AND DISTRICT I REGIONAL

NETWORK LIAISON FOR THE EARLY HEARING DETECTION AND INTERVENTION PROGRAM

CEREMONIAL SIGNING IN CONNECTICUT FOR CMV HB 5525/PUBLIC ACT 15-10

JULY 28,2015

LEARNING OBJECTIVES

Familiarize audience with data regarding the lack of knowledge about CMV by healthcare providers and parents

Encourage an understanding of the partnerships beneficial to the passage and implementation of CMV legislation in Connecticut

Describe the benefits and limitations of testing for cCMV and share preliminary data

Share CMV resources developed in Connecticut and disseminated throughout the state

IMPETUS FOR CHANGE

CMV IS THE MOST COMMON CONGENITAL VIRAL INFECTION IN THE US; ONE IN 150 CHILDREN IS BORN IN THE US WITH cCMV EACH YEAR

CONGENITAL CMV CAN CAUSE : HEARING LOSS VISION LOSS MENTAL DISABILITY MICROCEPHALY(SMALL HEAD OR BRAIN) INTRACRANIAL CALCIFICATIONS LACK OF COORDINATION CEREBRAL PALSY FEEDING ISSUES/FAILURE TO THRIVE(FTT) SLEEPING, BEHAVIOR AND SENSORY ISSUES SEIZURES DEATH

IMPETUS FOR LEGISLATION

Infants with asymptomatic CMV outnumber those that show symptoms 3 to 1 In a large # of children with asymptomatic CMV, hearing loss is the only sequela Approximately 50% of hearing loss from cCMV infection is either late-onset or progressive Type and severity of hearing loss is variable

PREVENTION OF cCMV IS POSSIBLE THROUGH INFECTION CONTROL PRACTICES, BUT MOST PREGNANT WOMEN ARE NOT AWARE OF THESE PREVENTION METHODS

NATIONAL CENTER FOR HEARING ASSESSMENT AND MANAGEMENT

Survey of 2000 pediatricians: 2005 compared to 2012

No improvement in knowledge about risk factors for hearing loss that may lead to late onset or progressive hearing loss

SURVEY BY AMERICAN COLLEGE OF OB/GYNs

Survey in 2007: 305/606 OB/GYNs responded

CDC and American College Of OB/GYNs(2000 Practice Bulletin) recommend OB/GYNs counsel pregnant women on prevention of CMV transmission via urine,saliva and other bodily fluid

Fewer than half (44%) of OB/GYNs surveyed reported counseling their patients about recommendations for reducing risk of CMV infection

HEALTH STYLES SURVEY OF U.S. WOMEN AND MEN

Survey in 2010: 4184 participated

2181 Women/2003 Men

13% of U.S. Women and 7% of U.S. Men Had Heard of Congenital Cytomegalovirus

TRUNK BAY IN ST JOHN,USVI

UNIVERSAL NEWBORN HEARING SCREENING AND CMV LEGISLATION

TIMELINE IN CONNECTICUT

Universal Newborn Hearing Screening mandate passed in 1999

2000 Universal Newborn Hearing Screening implemented in all 31 CT birth facilities

2002 Newborn Hearing Screening results started to be reported to DPH electronically

2003 Hearing screening equipment was standardized statewide

TIMELINE IN CONNECTICUT (CONT)

2014 HB 5147 was introduced-An Act Concerning Newborn Screening for Globoid Cell Dystrophy and Cytomegalovirus and Establishing A Public Education Program For CMV

2014 HB 5147 passed the Public Health Committee and the House but was not voted on by the Senate before the close of session - estimated first year cost of 40K was “deal breaker”

January 2015 HB 5525 CMV legislation proposed again

March 2015 passed Public Health Committee after CMV prevention education component was removed - again, concern regarding cost

May 26,2015 HB 5525/Public Act 15-10 - An Act Concerning Cytomegalovirus - passed with bipartisan support

CONNECTICUT GENERAL STATUTES, Sec. 19a-55.

The administrative officer or other person in charge of each institution caring for newborn infants shall administer a screening test for cytomegalovirus, provided such screening test shall be administered within available appropriations on and after January 1, 2016. Such screening tests shall be administered as soon after birth as is medically appropriate.

The administrative officer or other person in charge of each institution caring for newborn infants shall report any case of cytomegalovirus that is confirmed as a result of a screening test administered pursuant to subdivision (3) of subsection (b) of this section to the Department of Public Health in a form and manner prescribed by the Commissioner of Public Health.

The provisions of this section shall not apply to any infant whose parents object to the test or treatment as being in conflict with their religious tenets and practice.

EFFECTS OF CMV TESTING COMPONENT PASSING LEGISLATION

As a result of the bill passing, it was necessary to educate primary care providers and hospitals about the CMV legislation which took effect January 1st, 2016. The Connecticut Department of Public Health was the lead agency in this endeavor-in partnership with several others Partners:

Birth facilities and midwives; Audiologists Connecticut Chapter of the American Academy of Pediatrics (AAP) AAP Early Hearing Detection and Intervention(EHDI) Chapter Champion - Dr. Brenda Balch CT Children’s Medical Center, Division of Infectious Diseases Yale-New Haven Children’s Hospital, Department of Pediatric Infectious Diseases Primary Care Providers

EFFECTS (CONT)

June-July 2015: EHDI program notifies birth hospitals and conducts survey to assess current practices

September-October 2015:

• Website revisions on the Connecticut Department of Public Health Early Hearing Detection and Intervention website- www.ct.gov/dph/ehdi

• Revised Hospital Service Delivery flow chart

• Department of Public Health updated Connecticut’s hearing test brochure for families to include information on CMV testing. Included in this brochure is a section on CMV prevention

• In collaboration with the Connecticut Chapter of the American Academy of Pediatrics, DPH EHDI has created a resource sheet for pediatric care providers, entitled: The Role of the Primary Healthcare Provider in Cytomegalovirus Screening and Follow Up Recommendations and Monitoring

EFFECTS (CONT)

Fall 2015: Connected with Infectious Diseases specialists

December 8,2015 The Connecticut Chapter of the American Academy of Pediatrics (AAP) held a webinar entitled: Update on Statewide Neonatal CMV. To view these slides or listen to the audio please go to:http://ct-aap.org/2015.

November - December 2015:

• Add reporting fields to existing Newborn Screening System (EHDI database)

• EHDI staff respond to numerous inquiries as hospitals revise their internal policies and procedures

IMPORTANT TALKING POINTS FOR CONNECTICUT PRIMARY CARE

PROVIDERS

Congenital CMV is the most common cause of nonhereditary sensorineural hearing loss

Connecticut hospitals conduct two hearing screens prior to discharge

If either ear does not pass after a second inpatient hearing screen prior to 21 days of age, CMV testing is warranted prior to discharge

PCR assay for CMV on saliva or urine is the preferred method of testing. Urine culture is also acceptable

TALKING POINTS (CONT)

The primary care provider is responsible for sharing the CMV results with the parents or guardian

All infants who fail their second newborn hearing screen, regardless of their CMV status, should have a full pediatric audiology evaluation as soon as possible

Infants with a positive CMV test are encouraged to be evaluated by the pediatric infectious disease specialists at CCMC or Yale

BENEFITS OF THIS LEGISLATION

Increases CMV awareness among public health officials

Through the “backdoor” resulted in education materials being developed and distributed to healthcare primary care providers, hospitals and parents

Resulted in the development of resource materials with a focus on CMV prevention for OB/GYNs and parents

This protocol allows for a more timely diagnosis of the etiology of the infants hearing loss and is less expensive than imaging and genetic testing

Increases healthcare workers’ and parents’ awareness of CMV research and possible intervention strategies for congenital CMV

LIMITATIONS/CONCERNS REGARDING CMV LEGISLATION

Law mandates testing only for infants who do not pass their hearing screening. We know that hearing loss may be late onset or progressive and therefore infants with a very mild hearing loss at birth or those with late-onset hearing loss due to CMV may be missed

After 3 weeks of age, the PCR for CMV on saliva and urine and the urine culture cannot differentiate between cCMV and CMV acquired postnatally

Breastfeeding in close proximity to the collection of the saliva sample may skew the results

LIMITATIONS/CONCERNS(CONT)

Some medical professionals and CMV experts oppose public policy and legislation mandating medical practice

There is no drug licensed to treat cCMV, although studies are ongoing using antivirals, such as ganciclovir and valganciclovir

There is currently no commercially licensed vaccine available for CMV

PRELIMINARY DATA SINCE CONNECTICUT ENACTED THE CMV

LEGISLATION REQUIRING CMV TESTING IN INFANT S WHO FAIL

THE NEWBORN HEARING SCREEN

CMV Not Detected All Facilities: 294 (84%)

CMV screenings documented: 349 (77%) No CMV screenings documented: 102 (23%)

Hearing Status All Facilities: 2 Congenital Losses (1 bilateral, 1 unilateral)

1 Late Onset (bilateral) 3 Normal – Passed DX

1 Normal - Passed out-patient screening

CMV Detected All Facilities: 7 (2%)

Rev. 2/2017

1/1/2016 – 12/31/2016 Total Did Not Pass Inpatient Hearing Screening: 451

CMV Result Not Documented (blank field) All Facilities: 46 (13%)

Result Documented as “Unknown” All Facilities: 2 (%)

Screening conducted < 21 days of Birth All Facilities: 336 (96%)

Screening conducted > 21 days of Birth All Facilities: 13 (4%)

Note 2: The data set used in this table contains children who were both born in CT and whose parents have a CT address.

EGA of < 35 weeks All Facilities: 13 (100%)

All Connecticut Birthing Facilities CMV Stats for 2016

ENDEAVORS IN PROGRESS

1) July 2106 CT Department of Public Health began work on additional educational materials focusing on prevention - despite the education component having been removed from the bill February 2017 - OB/GYN and parent resources completed and preparing to disseminate to physician offices 2) Project: In early stages of nationwide survey of state daycare licensing agencies regarding CMV education of daycare providers and preventive measures presently in daycare facilities

2015: After working for two years with state legislators, government agencies, medical professionals, media, and CMV families, Lisa helped Connecticut become the second state in the U.S. to pass a CMV testing law. Soon after the CMV testing law passed,Connecticut’s Department of Public Health added information on CMV prevention to their website, which enabled Lisa to direct the government TV station to it for a "bulletin"  

LISA SAUNDERS, CMV MOM

CMV MOM(Continued)

 2016: The Connecticut Office of Early Childhood’s Division of Licensing for Child Care Providers/Operators now links to the Connecticut Department of Public Health’s webpage, “Congenital Cytomegalovirus,” under “Disease and Prevention” on its website. (Lisa is still hoping CMV prevention will be included in the licensing training.)

CMV MOM(CONTINUED)

• Occupational Safety and Health Administration (OSHA) is now working on publications to provide CMV prevention education for childcare workers in daycare centers nationwide.

• The MotherToBaby.org Education Committee is creating a new fact sheet specifically for day care workers to discuss overall infection risks and will include CMV.

• Certified Industrial Hygienist of “The Worker Institute” at Cornell and Director of Workplace Health and Safety Program is currently writing an article on contagious diseases in the workplace for a labor website and is now including CMV.

ANY QUESTIONS?

Phone: (860) 509-8251 • Fax: (860) 509-8132410 Capitol Avenue, P.O. Box 340308

Phone: (860) 509-8000 • Fax: (860) 509-7184 • VP: (860) 899-1611410 Capitol Avenue, P.O. Box 340308

Hartford, Connecticut 06134-0308www.ct.gov/dph Affirmative Action/Equal Opportunity Employer

Community, Family, and Health Equity Section Early Hearing Detection and Intervention (EHDI) Program

March 1, 2017

Dear Obstetirc Health Care Provider:

Most women are unaware of Cytomegalovirus and the risk of infection during pregnancy. As you may know, beginning January 1, 2016, state law requires hospitals to screen newborns who do not pass newborn hearing screening for Cytomegalovirus (CMV) and report positive results to the Department of Public Health (C.G.S. § 19a-55). As a healthcare provider caring for pregnant women, you are in a unique position to discuss CMV with expectant parents at the same time that you talk about prevention of neonatal infectious diseases.

Congenital CMV infections can only be prevented by preventing CMV infection in pregnant women. There is no available vaccine for preventing CMV; however, pregnant women can take steps that may reduce their exposure to CMV, including good hygiene practices. Please find a few resources enclosed that we hope you will find helpful, including a CMV awareness poster that outlines tips for pregnant women to protect herself and her unborn baby from CMV.

Why are state legislatures around the country beginning to pass CMV screening mandates? CMV is the most common infectious cause of congenital disabilities and the leading non-genetic cause of sensorineural hearing loss. CMV screening protocol allows for more timely determination of the presence, cause, and nature of hearing loss; as well as for education on the research and possible intervention strategies if congenital CMV is involved.

All infants who fail the second newborn hearing screen, regardless of their CMV status, should have a full pediatric audiological evaluation as soon as possible. Other than necessary follow-up with an audiologist, the further management of babies who are CMV positive is not well-defined. Studies are ongoing to determine what types of therapy are of greatest benefit to CMV-infected infants. Infants with suspected congenital CMV infections should be evaluated by physicians who specialize in these infections, such as the Pediatric Infectious Diseases Department at Yale (203-785-4730) or Connecticut Children's Medical Center (860 545-9490).

For additional information regarding CMV and Connecticut’s law, visit our web site: www.ct.gov/dph/ehdi and click on the red “CT EHDI CMV” tab. Please feel free to contact us at 860-509-8074, or by email, with any questions or if we can provide any additional information.

Sincerely, Amy Mirizzi, MPH, CPH Brenda Kinsella Balch, MD amy.mirizzi@ct.gov Brenda.balch@ct.gov EHDI Coordinator AAP CT EHDI Chapter Champion and Regional Network Liaison

Bibliography: Part 1● Adler SP, Finney JW, Manganello AM, Best AM. (2004, October).Prevention of child-to-mother transmission of cytomegalovirus among pregnant

women. Retrieved from National Center for Biotechnology Information: http://www.ncbi.nlm.nih.gov/pubmed/15480372

● Adler, Stuart, MD, Emeritus Professor of Pediatrics and Chairman, Division of Infectious Disease. (2014, Feb. 28). Public Hearing Testimony, Raised H.B. No. 5147 . Retrieved from Connecticut General Assembly: http://www.cga.ct.gov/2014/PHdata/Tmy/2014HB-05147-R000228-Stuart%20Adler,%20Emeritus%20Professor%20of%20Pediatrics%20and%20Chairman,%20Division%20of%20Infectious%20Disease-TMY.PDF

● Armstrong, Farah,President and Founder, Maddie's Mission. (2014, Feb. 28). Public Hearing Testimony, Raised H.B. No. 5147 . Retrieved from Connecticut General Assembly : http://www.cga.ct.gov/2014/PHdata/Tmy/2014HB-05147-R000228-Farah,%20Armstrong-TMY.PDF

● Arvin, A. et. al., . (2004). Vaccine Development to Prevent Cytomegalovirus Disease: Report from the National Vaccine Advisory Committee. Retrieved from Oxford Journals: http://cid.oxfordjournals.org/content/39/2/233.long

● Bailey, Jenny Meeden, Texas, baby first in Houston to receive ganciclovir treatment. (2014, Feb. 28). Public Hearing Testimony, Raised H.B. No. 5147. Retrieved from Connecticut General Assembly: http://www.cga.ct.gov/2014/PHdata/Tmy/2014HB-05147-R000228-Jenny%20Meeden%20Bailey-TMY.PDF

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● Blazek, Nicole, Senior Clinical Content Editor. (2014, June 21).Educate pregnant women to prevent congenital CMV. Retrieved Reference: 1.Pina AL. “Breaking the Silence About Congenital CMV.” Presented at: AAPN 2014. Jun 17-22; Nashville, Tenn., from The Clinical Advisor: http://www.clinicaladvisor.com/educate-pregnant-women-to-prevent-congenital-cmv/article/357115/

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● Cannon, Michael J.; Davis, Katherine Finn. (2005, June 20). Washing our hands of the congenital cytomegalovirus disease epidemic. Retrieved from BMC Public Health: http://www.biomedcentral.com/1471-2458/5/70

● Carlson, Amanda, MD; Norwitz, Errol R MD, PhD; Stiller, Robert J , MD. (Fall 2010). Cytomegalovirus Infection in Pregnancy: Should All Women Be Screened? . Retrieved from National / Center for Biotechnology Information : http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3046747

● Centers for Disease Control and Prevention. (n.d.). Retrieved from Congenital CMV Infection Trends and Statistics: http://www.cdc.gov/cmv/trends-stats.html

Bibliography: Part II● Centers for Disease Control and Prevention (CDC). (n.d.).Cytomegalovirus (CMV) and Congenital CMV Infection. Retrieved from Centers for

Disease Control and Prevention (CDC): http://www.cdc.gov/cmv/index.html

● Centers for Disease Control and Prevention (CDC). (n.d.). Infant Health. Retrieved from Centers for Disease Control and Prevention (CDC): http://www.cdc.gov/nchs/fastats/infant-health.htm

● Centers for Disease Control and Prevention (CDC). (n.d.). State and Territorial Data. Retrieved from Centers for Disease Control and Prevention (CDC): http://www.cdc.gov/nchs/fastats/state-and-territorial-data.htm

● Children's Hearing and Speech Services. (n.d.). Retrieved from Utah Department of Health: http://www.health.utah.gov/cshcn/programs/ehdi.html

● Cody, S. (2015, May 6). CT Now. Retrieved from CT Moms Fight for CMV Legislation : "Connecticut Moms Fight for CMV Legislation":http://www.ctnow.com/family/ctnow-ct-moms-fight-for-cmv-legislation-20150505,0,3850658.column

● Cody, S. (2015, May 27). New law in Connecticut to fight number one viral cause of birth defects. Retrieved from Fox CT: http://foxct.com/2015/05/27/new-law-in-connecticut-to-fight-number-one-viral-cause-of-birth-defects/

● Congenital Cytomegalovirus Infection Time To Test Newborns. (2014, July 1). Retrieved December 6, 2014, from ENT Today: http://www.enttoday.org/article/congenital-cytomegalovirus-infection-time-to-test-newborns/

● Cytomegalovirus (CMV) education bill on hold for now. (2014, May 8). Retrieved from Fox CT: http://foxct.com/2014/05/08/cytomegalovirus-cmv-education-bill-on-hold-for-now/

● Cytomegalovirus-CMV: H.B. 81 (2013) Public Health Initiative in conjunction with the Utah Department of Health. (n.d.). Retrieved from Utah Department of Health: http://www.health.utah.gov/cshcn/PDF/CMV%20Utah%20Flyer.pdf

● Demmler-Harrison,Gail, MD,Director, Congenital CMV Disease Registry and Research Program. (2015, Feb. 20). Public Hearing Testimony, Raised H.B. No. 5525. Retrieved from Connectictut General Assembly: http://www.cga.ct.gov/2015/PHdata/Tmy/2015HB-05525-R000220-Gail%20Demmler%20Harrison,%20MD-TMY.PDF

● Doutre, Sara, co-founder, Utah CMV Council; Menlove,Ronda, Utah House of Representatives,. (n.d.). Retrieved from Utah CMV Council: http://www.utahcmvcouncil.org/about-us/

● Goderis, Julie, MD, et al. (2014, October 27). Hearing Loss and Congenital CMV Infection: A Systematic Review. Retrieved from Pediatrics: http://pediatrics.aappublications.org/content/early/2014/10/21/peds.2014-1173.abstract#aff-1

● Greenlee, Janelle, President and Founder, Stop CMV. (2014, Feb. 28).Public Hearing Testimony, Raised H.B. No. 5147 . Retrieved from Connecticut General Assembly: http://www.cga.ct.gov/2014/PHdata/Tmy/2014HB-05147-R000228-Janelle%20Greenlee,%20President%20and%20Founder,%20Stop%20CMV-TMY.PDF

Bibliography: Part III● H.B. No. 5147. (2014). Retrieved from Connecticut General Assembly : http://www.cga.ct.gov/asp/cgabillstatus/cgabillstatus.asp?

selBillType=Bill&bill_num=5147&which_year=2014

● Kimberlin, David W., M.D., et al. (2015, March 5). Valganciclovir for Symptomatic Congenital Cytomegalovirus Disease. Retrieved from The New Enland Journal of Medicine: http://www.nejm.org/doi/full/10.1056/NEJMoa1404599

● Knowledge and Awareness of Congenital Cytomegalovirus Among Women. (2006, December 28). Retrieved from National Center for Biotechnology Information: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1779612/

● Knowledge and Practices of Obstetricians and Gynecologists Regarding Cytomegalovirus Infection During Pregnancy --- United States, 2007. (n.d.). Retrieved from Centers for Disease Control and Prevntion (CDC): http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5703a2.htm

● Lopez, Adriana, M.H.S., et al. (n.d.). Preventing Congenital Toxoplasmosis . Retrieved February 7, 2015, from CDC: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4902a5.htm

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Bibliography: Part IV● Saunders, L. (2009). Anything But a Dog! The perfect pet for a girl with congenital CMV (cytomegalovirus). Retrieved from http://

www.amazon.com/Anything-But-Dog-Congenital-Cytomegalovirus/dp/1588329968/ref=sr_1_1?s=books&ie=UTF8&qid=1340644532&sr=1-1&keywords=anything+but+a+dog+lisa+saunders

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