The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Committee on Health Policy
BILL: CS/SB 168
INTRODUCER: Senator Polsky
SUBJECT: Congenital Cytomegalovirus Screenings
DATE: January 24, 2024
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Looke Brown HP Fav/CS
2. AHS
3. FP
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/SB 168 amends newborn health screening requirements in s. 383.145, F.S., to require that all
newborns who are born in a hospital that provides neonatal intensive care services and who are
born before 35 weeks gestation, require cardiac care, or require medical or postsurgical treatment
for at least three weeks, be tested for the Cytomegalovirus (CMV). Additionally, the bill requires
that if the newborn is transferred to another hospital for higher level care, the receiving hospital
must administer the CMV test if the test was not already performed at the transferring hospital or
birth facility. The bill also requires a CMV test if the newborn will be transferred or admitted for
intensive and prolonged care, regardless of whether the newborn failed his or her hearing
screening.
The bill creates a new requirement that CMV screening and medically necessary follow-up
reevaluations leading to diagnosis are covered benefits for Medicaid patients and that private
health insurance policies and health maintenance organizations (HMO) that provide
comprehensive coverage must compensate providers for the covered benefit at the contracted
rate. The bill provides that a child who is diagnosed with CMV must be referred to a primary
care physician and to the Children’s Medical Services (CMS) Early Intervention Program for
management of his or her condition.
The bill provides an effective date of July 1, 2024.
REVISED: BILL: CS/SB 168 Page 2
II. Present Situation:
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.
1
In the United States, nearly one in
three children are already 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 (variety) of the virus. Most people with
CMV infection have no symptoms and aren’t aware that they have been infected.
2
A pregnant woman can pass CMV to her unborn baby. The virus in the woman’s blood can cross
through the placenta and infect the baby. This can happen when a pregnant woman is infected
with CMV for the first time or is infected with CMV again during pregnancy.
3
Some babies with congenital CMV infection have health problems that are apparent at birth or
that develop later during infancy or childhood. In the most severe cases, CMV can cause the
death of an unborn baby (pregnancy loss).
Some babies with congenital CMV infection have signs at birth. These signs include:
Rash
Jaundice (yellowing of the skin or whites of the eyes)
Microcephaly (small head)
Low birth weight
Hepatosplenomegaly (enlarged liver and spleen)
Seizures
Retinitis (damaged eye retina)
Some babies with signs of congenital CMV infection at birth may have long-term health
problems, such as:
Hearing loss
Developmental and motor delay
Vision loss
Microcephaly (small head)
Seizures
Some babies without signs of congenital CMV infection at birth may have hearing loss. Hearing
loss may be present at birth or may develop later, even in babies who passed the newborn
hearing test.
4
1
About Cytomedalovirus (CMV), Centers for Disease Control and Prevention, available at
https://www.cdc.gov/cmv/overview.html (last visited Jan. 18, 2024).
2
Id.
3
Babies Born with Conginital Cytomegalovirus (CMV), Centers for Disease Control and Prevention, available at
https://www.cdc.gov/cmv/congenital-infection.html, (last visited Jan. 18, 2024).
4
Id. BILL: CS/SB 168 Page 3
CMV is the most common infectious cause of birth defects in the United States. About one out of
200 babies is born with congenital CMV. One out of five babies with congenital CMV 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.
Babies who show signs of congenital CMV disease can be treated with medicines called
antivirals. Antivirals may decrease the severity of hearing loss. Babies who get treated with
antivirals should be closely monitored by their doctor because of possible side effects.
5
Newborn and Infant Hearing Screening
Section 383.145, F.S., requires that a newborn hearing screening must be conducted on all
newborns in hospitals in this state on birth admission. When a newborn is delivered in a facility
other than a hospital, the parents must be instructed on the importance of having the hearing
screening performed and must be given information to assist them in having the screening
performed within three months after the child’s birth.
6
Before a newborn is discharged from the hospital or other state-licensed birthing facility that
provides maternity and newborn care services, and unless objected to by the parent or legal
guardian,
7
the newborn must be screened for the detection of hearing loss to prevent the
consequences of unidentified disorders.
8
Additionally, within 30 days of discharge from the
hospital, each such facility must refer the newborn to a licensed audiologist, physician, or
hospital for screening for detection of hearing loss.
9
If the birth is a home birth, the health care
provider in attendance must provide the referral to a licensed audiologist, hospital, or other
newborn hearing screening provider within 30 days.
10
Section 383.145, F.S., also requires that all screenings be conducted by a licensed audiologist, a
licensed physician, or appropriately supervised individual who has completed documented
training specifically for newborn hearing screening.
11
When ordered by the treating physician,
screening of a newborn’s hearing must include auditory brainstem responses, or evoked
otacoustic emissions, or appropriate technology as approved by the United States Food and Drug
Administration (FDA).
12
If a newborn fails his or her hearing screening, the hospital or birthing facility must administer a
test approved by the FDA, or other diagnostically equivalent test, to screen for CMV before the
newborn becomes 21 days old or before discharge, whichever is sooner. A child who is
diagnosed as having a permanent hearing impairment must be referred to the primary care
5
Congenital CMV and Hearing Loss, Centers for Disease Control and Prevention, available at
https://www.cdc.gov/cmv/hearing-loss.html, (last visited Jan. 17, 2024).
6
Section 383.145(3)(i), F.S.
7
Section 383.145(3)(c), F.S.
8
Section 383.145(3)(a), F.S.
9
Section 383.145(3)(b), F.S.
10
Section 383.145(3)(d), F.S.
11
Section 383.145(3)(e), F.S.
12
Section 383.145(3)(h), F.S. BILL: CS/SB 168 Page 4
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 serving the geographical area in which the child resides.
13
Any person who
is not covered through insurance and cannot afford the costs for testing must be given a list of
newborn hearing screening providers who provide the necessary testing free of charge.
14
Early Steps
Early Steps is Florida’s early intervention system that offers services to eligible infants and
toddlers, from birth to 36 months, who have or are at-risk for developmental disabilities or
delays. Early intervention supports families and caregivers to increase their child’s participation
in daily activities and routines that are important to the family. Fifteen local Early Steps offices
throughout the state receive referrals from various primary referral sources. Infants and toddlers
are assessed in the following developmental domains to determine eligibility: physical,
cognitive, communication, social-emotional and adaptive. Each child receives an Individualized
Family Support Plan that meets his or her unique needs. Families also receive support to develop
the skills and confidence needed in helping their child learn and develop.
15
Medicaid and Private Health Insurance Coverage
Section 383.145(3)(k), F.S., currently requires that the initial procedure for screening the hearing
of the newborn or infant and any medically necessary follow-up reevaluations leading to
diagnosis are a covered benefit for Medicaid patients and that all private health insurance
policies and health maintenance organizations providing comprehensive health coverage must
compensate providers for the covered benefit at the contracted rate.
Mandated Health Insurance Coverages
Section 624.215, F.S., requires every person or organization seeking consideration of a
legislative proposal which would mandate a health coverage or the offering of a health coverage
by an insurance carrier, to submit to the AHCA and the legislative committees having
jurisdiction, a report that assesses the social and financial impacts of the proposed coverage. As
of January 22, 2024, Senate Committee on Health Policy staff has not received this report.
Under the federal Patient Protection and Affordable Care Act (ACA), individuals and small
businesses can shop for health insurance coverage on the federal marketplace. All non-
13
Section 383.145(3)(k), F.S.
14
Section 383.145(3)(l), F.S.
15
Early Steps, Florida Department of Health, available at https://www.floridahealth.gov/programs-and-services/childrens-
health/early-
steps/index.html#:~:text=Early%20Steps%20is%20Florida's%20early,for%20developmental%20disabilities%20or%20delays
(last visited Jan. 19, 2024). BILL: CS/SB 168 Page 5
grandfathered plans
16
must include minimum essential coverage (MEC),
17
including an array of
services that includes the 10 essential health benefits (EHBs). These 10 EHBs are further
clarified or modified each year through the federal rulemaking process and are open for public
comment before taking effect. The 10 general categories for the EHBs are:
Ambulatory services (outpatient care);
Emergency services;
Hospitalization (inpatient care);
Maternity and newborn care.
Mental health and substance abuse disorder services;
Prescription drugs.
Rehabilitative services and rehabilitative services and devices;
Laboratory services;
Preventive care and chronic disease management; and
Pediatric services, including oral and vision care.
18
States are free to modify the EHBs offered in their states by adding coverage; however, because
of concerns that federal funds would be used on costly mandated coverages that were not part of
the required EHBs, the ACA contains a provision requiring that, starting in 2016, the states
would have to pay for the cost of the coverage. As a result, the State of Florida may be required
to defray the costs of any additional benefits beyond the required EHBs put in place after 2011.
19
Examples of health insurance benefits mandated under Florida law include:
Coverage for certain diagnostic and surgical procedures involving bones or joints of the jaw
and facial region (s. 627.419(7), F.S.);
Coverage for bone marrow transplants (s. 627.4236, F.S.);
Coverage for certain cancer drugs (s. 627.4239, F.S.);
Coverage for any service performed in an ambulatory surgical center (s. 627.6616, F.S.);
Diabetes treatment services (s. 627.6408, F.S.);
Osteoporosis (s. 627.6409, F.S.);
Certain coverage for newborn children (s. 627.641, F.S.);
Child health supervision services (s. 627.6416, F.S.);
Certain coverages related to mastectomies (s. 627.6417, F.S.);
Mammograms (s. 627.6418, F.S.); and
Treatment of cleft lip and cleft palate in children (s. 627.64193, F.S.).
16
A “grandfathered health plan” are those health plans, both individual and employer plans, that maintain coverage that were
in place prior to the passage of the PPACA or in which the enrollee was enrolled on March 23, 2010 while complying with
the consumer protection components of the PPACA. If a group health plan enters a new policy, certificate, or contract of
insurance, the group must provide the new issuer the documentation from the prior plan so it can be determined whether there
has been a change sufficient to lose grandfather status. See 26 U.S.C. 7805 and 26 C.F.R. s. 2590.715-1251(a).
17
To meet the individual responsibility provision of the ACA statute, a benefit plan or coverage plan must be recognized as
providing minimum essential coverage (MEC). Employer based coverage, Medicaid, Medicare, CHIP (i.e. Florida KidCare),
and TriCare would meet this requirement.
18
42 U.S.C. s. 18022(b)(1)(A)-(J).
19
See 42 U.S.C. s. 18031(d)(3)(B)(ii). BILL: CS/SB 168 Page 6
Florida’s current EHB includes anti-viral medications for CMV.
20
III. Effect of Proposed Changes:
CS/SB 168 amends s. 383.145, F.S. to require each hospital that provides neonatal intensive care
services to administer an FDA-approved test for CMV, or other diagnostically equivalent test, to
each newborn admitted to the hospital as the result of a premature birth prior to 35 weeks
gestation, for cardiac care, or for medical or postsurgical treatment requiring an anticipated stay
of three weeks or longer. The CMV screening must be initiated prior to the newborn being 21
days of age.
The bill requires that if the newborn is transferred to another hospital for higher level care, the
receiving hospital must administer the CMV test if the test was not already performed at the
transferring hospital or birth facility. The bill also requires a CMV test if the newborn will be
transferred or admitted for intensive and prolonged care, regardless of whether the newborn
failed his or her hearing screening.
The bill amends s. 383.145(3)(k), F.S., to create a new requirement that CMV screening and
medically necessary follow-up reevaluations leading to diagnosis are covered benefits for
Medicaid patients and that private health insurance policies and HMOs providing comprehensive
health coverage must compensate providers for the covered benefit at the contracted rate. The
bill provides that a child who is diagnosed with CMV must be referred to a primary care
physician and to the CMS Early Intervention Program for management of his or her condition
and be deemed eligible for a baseline evaluation and any medically necessary follow-up
reevaluations and monitoring.
The bill provides an effective date of July 1, 2024.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
None.
20
Id. BILL: CS/SB 168 Page 7
E. Other Constitutional Issues:
None.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
The bill may have an indeterminate positive fiscal impact on the families of newborns
who are diagnosed with CMV due to the required screening, are eligible for services, and
are able to manage the condition prior to any permanent hearing loss occurring.
The bill may have an indeterminate negative fiscal impact on hospitals that are required
to perform additional CMV tests due to the requirements in the bill.
C. Government Sector Impact:
The bill may have a negative fiscal impact on the DOH if the number of CMV screenings
the DOH is required to perform under the newborn screening program increases due to
the requirements in the bill and if more children are eligible to for the CMS Early
Intervention Program. As of this writing, the DOH has not submitted an estimate of such
fiscal impact.
The bill may have a fiscal impact on the Medicaid program. As of this writing, the
Agency for Health Care Administration has not submitted an estimate of such fiscal
impact.
The bill may have a negative fiscal impact on state government if the state is required to
defray additional costs related to adding CMV screenings or treatments to the specified
mandated insurance coverage.
VI. Technical Deficiencies:
None.
VII. Related Issues:
CS/SB 168 amends s. 383.145(3)(k), F.S., to create a new requirement that CMV screening and
medically necessary follow-up reevaluations leading to diagnosis are covered benefits for
Medicaid patients and that private health insurance policies and HMOs providing comprehensive
health coverage must compensate providers for the covered benefit at the contracted rate,
however, the bill is not specific as to what services are required to be covered under the
medically necessary follow-up reevaluations. It may be advisable to clarify what services are
required to be covered under the bill. BILL: CS/SB 168 Page 8
VIII. Statutes Affected:
This bill substantially amends section 383.145 of the Florida Statutes.
IX. Additional Information:
A. Committee Substitute – Statement of Substantial Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
CS by Health Policy on January 23, 2024.
The CS:
Increases the gestational age, from 33 to 35 weeks, for the requirement that a hospital
providing NICU services must administer a CMV test to infants born earlier than that
gestational age;
Removes the requirement to administer a CMV test to newborns who are small for
their gestational age; and
Moves the requirement to administer a CMV test when a newborn is being transferred
for more intensive care from the birthing hospital to the hospital receiving the
transfer.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.