HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: HB 435 Newborn Hearing Screenings
SPONSOR(S): Melo and others
TIED BILLS: IDEN./SIM. BILLS: SB 394
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Healthcare Regulation Subcommittee Guzzo McElroy
2) Health Care Appropriations Subcommittee
3) Health & Human Services Committee
SUMMARY ANALYSIS
Cytomegalovirus (CMV) is a common virus that infects people of all ages. Over half of adults are infected with
CMV by age 40, and approximately one of every 200 babies is born with congenital CMV (CCMV). About one
in five babies with CCMV have long-term health problems, including hearing loss. Current law requires
hospitals to conduct a hearing screening on all newborns upon birth. Screening for congenital CMV is not
required under current law.
Florida’s Newborn Screening Program (NSP), operated by the Department of Health (DOH), screens all
newborns for metabolic, hereditary, and congenital disorders known to result in significant impairment of health
or intellect, including hearing loss and CCMV.
Before a newborn is discharged from a hospital or other state-licensed birthing facility, and unless objected to
by the parent or legal guardian, the newborn must be screened for the detection of hearing loss to prevent the
consequences of unidentified disorders. Under current law, if a newborn fails the hearing screening, the
hospital or other state-licensed birthing facility is required to administer an FDA-approved test, or other
diagnostically equivalent test, on the newborn to screen for CCMV. The CCMV test must be administered
before the newborn becomes 21 days of age or before discharge, whichever occurs earlier. In 2021, 8,500
newborns were tested for CCMV because they did not pass their hearing screening.
HB 435 requires hospitals and other state-licensed birthing facilities that provide maternity and newborn care
services to screen all newborns for CCMV, instead of only newborns who fail hearing screenings —as required
by current law. Additionally, the bill requires birth centers to refer all newborns for administration of CCMV
testing within 7 days after discharge. For home births, the bill requires the healthcare provider in attendance to
refer all newborns for CCMV testing within 7 days after the baby is born. The bill is expected to increase, from
8,500 to 224,000, the number of newborns tested annually for CCMV.
The bill has a significant negative fiscal impact on the Department of Health, and no fiscal impact on local
government.
The bill provides an effective date of July 1, 2023.
This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives .
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 FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Background
Florida Newborn Screening Program
The Legislature created the Florida Newborn Screening Program (NSP) within the Department of
Health (DOH), to promote the screening of all newborns for metabolic, hereditary, and congenital
disorders known to result in significant impairment of health or intellect.1 The NSP also promotes the
identification and screening of all newborns in the state and their families for environmental risk factors
such as low income, poor education, maternal and family stress, emotional instability, substance
abuse, and other high-risk conditions associated with increased risk of infant mortality and morbidity to
provide early intervention, remediation, and prevention services. 2
The NSP involves coordination across several entities, including the Bureau of Public Health
Laboratories Newborn Screening Laboratory in Jacksonville (state laboratory), DOH Children’s Medical
Services (CMS) Newborn Screening Follow-up Program in Tallahassee, and referral centers, birthing
centers, and physicians throughout the state.3 Health care providers in hospitals, birthing centers,
perinatal centers, county health departments, and school health programs provide screening as part of
the multilevel NSP screening process.4 This includes a risk assessment for prenatal women, and risk
factor analysis and screening for postnatal women and newborns as well as laboratory screening for
select disorders in newborns.5 The NSP attempts to screen all newborns for hearing impairment and to
identify, diagnose, and manage newborns at risk for select disorders that, without detection and
treatment, can lead to permanent developmental and physical damage or death. 6 While the NSP
attempts to screen all prenatal women and newborns, parents and guardians may decline the
screening.7
Health care providers perform non-laboratory NSP screening, such as hearing and risk factor analysis,
and report the results to the Office of Vital Statistics. If necessary, health care providers refer patients
to the appropriate health, education, and social services.8 Health care providers in hospitals and
birthing centers perform specimen collection for laboratory NSP screening by collecting a few drops of
blood from the newborn’s heel on a standardized specimen collection card. 9 The specimen card is then
sent to the state laboratory for testing.10 The results of the laboratory test are released to the newborn’s
health care provider. In the event that a newborn screen has an abnormal result, the baby’s health care
provider, or a nurse or specialist from NSP’s Follow-up Program provides follow-up services and
referrals for the child and his or her family.11
To administer the NSP, DOH is authorized to charge and collect a fee not to exceed $15 per live birth
occurring in a hospital or birth center.12 DOH must calculate the annual assessment for each hospital
and birth center, and then quarterly generate and mail each hospital and birth center a statement of the
1 S. 383.14(1), F.S.
2 Id.
3 S. 383.14, F.S.
4
Supra, note 1.
5 Id.
6 Florida Department of Health, Florida Newb orn Screening Guidelines. Available at https://floridanewbornscreening.com/wp-
content/uploads/NBS-Protocols-2022-FINAL.pdf (last visited March 28, 2023).
7 S. 383.14(4), F.S.; Rule 64C-7.008, F.A.C.; The health care provider must attempt to get a written statement of objection to be placed
in the medical record.
8 Id.
9 Florida Newborn Screening, What is Newb orn Screening? Available at https://floridanewbornscreening.com/parents/what-is-newborn-
screening/ (last visited March 28, 2023). See also, Florida Newborn Screening, Specimen Collection Card,
http://floridanewbornscreening.com/wp-content/uploads/Order-Form.png (last visited March 28, 2023).
10 Id.
11 Id.
12 S. 383.145(3)(g)1., F.S.
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 amount due.13 DOH bills hospitals and birth centers quarterly using vital statistics data to determine the
amount to be billed.14 DOH is authorized to bill third-party payers for the NSP tests and bills insurers
directly for the cost of the screening.15 DOH does not bill families that do not have insurance
coverage.16
The Legislature established the Florida Genetics and Newborn Screening Advisory Council to advise
DOH about which disorders to include in the NSP panel of screened disorders and the procedures for
collecting and transmitting specimens.17 Florida’s NSP currently screens for 58 conditions, 55 of which
are screened through the collection of blood spots. Screening of the other three conditions —hearing
screening, critical congenital heart defect (CCHD) or pulse oximetry, and congenital cytomegalovirus
(CCMV) targeted screening—are completed at the birthing facility through point of care (POC) testing. 18
Congenital Cytomegalovirus
Cytomegalovirus (CMV) is a common virus for people of all ages; however, a healthy person’s immune
system usually keeps the virus from causing illness. 19 In the United States, nearly one in three children
are infected with CMV by age five. Over half of adults have been infected with CMV by age 40. Once
CMV is in a person’s body, it stays there for life and can reactivate. A person can also be re-infected
with a different strain of the virus. Most people with CMV infection have no symptoms and aren’t aware
that they have been infected.20
CMV in a newborn is known as congenital CMV (CCMV). The virus in the woman’s blood can cross
through the placenta and infect the infant. This can happen when a pregnant woman is infected with
CCMV for the first time or is infected with CCMV again during pregnancy. 21 Some infants with CCMV
infection have health problems that are apparent at birth or that develop later during infancy or
childhood. In the most severe cases, CCMV can cause the death of an unborn child (pregnancy loss).
Infants with CCMV infection may have signs at birth, which include: 22
 Rash;
 Jaundice (yellowing of the skin or whites of the eyes);
 Microcephaly (small head);
 Low birth weight;
 Hepatosplenomegaly (enlarged liver and spleen);
 Seizures; and
 Retinitis (damaged eye retina).
13 Id.
14 S. 383.145(3)(g), F.S.
15 S. 383.145(3)(h), F.S.
16 Supra, note 3.
17 S. 383.14(5), F.S.
18 Department of Health, Agency Analysis of 2023 HB 435 (February 14, 2023).
19 About Cytomegalovirus (CMV), Centers for Disease Control and Prevention, https://www.cdc.gov/cmv/overview.html (last visited
March 29, 2023).
20 Id.
21 Babies Born with Congenital Cytomegalovirus (CMV), Centers for Disease Control and Prevention,
https://www.cdc.gov/cmv/congenital-infection.html, (last visited March 29, 2023).
22 Id.
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 Infants with signs of CCMV infection at birth may have long-term health problems, such as:23
 Hearing loss;
 Developmental and motor delay;
 Vision loss;
 Microcephaly (small head); and
 Seizures.
Some infants without signs of CCMV infection at birth may have hearing loss. Hearing loss may be
present at birth or may develop later, even in infants who passed the newborn hearing test. 24
CCMV is the most common infectious cause of birth defects in the United States. About one out of 200
children are born with CCMV. One out of five infants with CCMV will have symptoms or long-term
health problems, such as hearing loss. Hearing loss may progress from mild to severe during the first
two years of life, which is a critical period for language learning. Over time, hearing loss can affect a
child’s ability to develop communication, language, and social skills. 25
Infants may have hearing loss that may or may not be detected by newborn hearing test. CCMV
infection is diagnosed by detection of CCMV DNA in the urine, saliva (preferred specimens), or blood,
within three weeks after birth. Infection cannot be diagnosed using tests that detect antibodies to
CCMV. CCMV infection cannot be diagnosed using samples collected more than three weeks after
birth because testing after this time cannot distinguish between congenital infection and an infection
acquired during or after delivery.26
Infants who show signs of CCMV disease can be treated with medicines called antivirals. Antivirals
may decrease the severity of hearing loss. Infants who get treated with antivirals should be closely
monitored by their doctor because of possible side effects. 27
CCMV and the Newborn Screening Program
Section 383.145, F.S., requires a newborn hearing screening for all newborns in hospitals before
discharge.
Before a newborn is discharged from a hospital or other state-licensed birthing facility, and unless
objected to by the parent or legal guardian, the newborn must be screened for the detection of hearing
loss to prevent the consequences of unidentified disorders. 28 However, if the screening is not
completed before discharge due to scheduling or temporary staffing limitations, the screening must be
completed within 21 days after the birth.29
In 2022, the legislature enacted a law to provide additional testing requirements for hearing loss in
newborns.30 Now, if a newborn fails the hearing screening, the hospital or birthing facility is required to
administer an FDA-approved test, or other diagnostically equivalent test, on the newborn to screen for
CCMV. The CCMV test must be administered before 21 days of age or before discharge, whichever
occurs earlier.31
23
Id.
24 Id.
25 CMV Fact Sheet for Healthcare Providers, Centers for Disease Control and Prevention, https://www.cdc.gov/cmv/fact-
sheets/healthcare-providers.html#:~:text=Cytomegalovirus%20(CMV)%20is%20the%20most,Hearing%20loss (last visited March 29,
2023).
26 About Cytomegalovirus (CMV), Centers for Disease Control and Prevention, available at https://www.cdc.gov/cmv/overview.html (last
visited March 29, 2023).
27 Congenital CMV and Hearing Loss, Centers for Disease Control and Prevention, available at https://www.cdc.gov/cmv/hearing-
loss.html, (last visited March 29, 2023).
28 S. 383.145(3)(a), F.S.
29 S. 383.145(3)(g), F.S.
30 Ch. 2022-25, Laws of Fla.
31 S. 383.145(3)(a), F.S.
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 Before a newborn is discharged from a licensed birth center, such facility must refer the newborn to an
audiologist, a hospital, or other newborn hearing screening provider, for screening for detection of
hearing loss and referral for appointment must be made within 7 days after discharge. If the birth is a
home birth, the health care provider in attendance must provide a referral to an audiologist, a hospital,
or other newborn hearing screening provider within 7 days after the birth.32 If a newborn is born in a
licensed birth center or the birth is a home birth, and the newborn fails the hearing screening, the
newborn’s primary care provider must refer the newborn for administration of an FDA-approved test, or
other diagnostically equivalent test, on the newborn to screen for CMV. 33
All screenings must be conducted by a licensed audiologist, a licensed physician, or appropriately
supervised individual who has completed documented training specifically for newborn hearing
screening.34 When ordered by the treating physician, screening of a newborn's hearing must include
auditory brainstem responses, or evoked otoacoustic emissions, or appropriate technology as
approved by the United States Food and Drug Administration (FDA).35
A child who is diagnosed as having a permanent hearing impairment must be referred by the licensee
or individual who conducted the screening to the primary care physician for medical management,
treatment, and follow-up services. Furthermore, any child from birth to 36 months of age who is
diagnosed as having a hearing impairment that requires ongoing special hearing services must be
referred to the Children's Medical Services Early Intervention Program by the licensee or individual who
conducted the screening serving the geographical area in which the child resides.
In 2021, 8,500 newborns did not pass their hearing screenings. 36
Effect of the Bill
The bill expands CCMV testing to all newborns in Florida, approximately 224,000 babies annually,
rather than only those who fail a hearing screening.37 As a result, an additional 215,000 newborns will
be tested for CCMV annually.
The bill requires hospitals and other state-licensed birthing facilities that provide maternity and newborn
care services to screen all newborns for CCMV. Additionally, the bill requires birth centers to refer all
newborns for CCMV testing within 7 days after discharge. For home births, the bill requires the health
care provider in attendance to refer all newborns for CCMV testing within 7 days after the baby is born.
The bill provides an effective date of July 1, 2023.
B. SECTION DIRECTORY:
Section 1: Amends s. 383.145, F.S., relating to newborn and infant hearing screenings.
Section 2: Provides an effective date of July 1, 2023.
II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT
A. FISCAL IMPACT ON STATE GOVERNMENT:
1. Revenues:
None.
2. Expenditures:
32 S. 383.145(3)(d), F.S.
33 S. 383.145(3)(e), F.S.
34 S. 383.145(3)(f), F.S.
35 S. 383.145(3)(i), F.S.
36 Supra note 18.
37 Supra note 18.
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 See fiscal comments.
B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
1. Revenues:
None.
2. Expenditures:
None.
C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
Medicaid, private insurers, and families would be billed for the CCMV tests. The estimated cost for
CCMV testing by urine polymeras