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 Appropriations
BILL: SB 7070
INTRODUCER: Appropriations Committee on Health and Human Services
SUBJECT: Sickle Cell Disease Research and Treatment Education
DATE: February 26, 2024 REVISED:
ANALYST STAFF DIRECTOR REFERENCE ACTION
AHS Submitted as Comm.
Gerbrandt McKnight
Bill/Fav
1. Gerbrandt Sadberry AP Favorable
I. Summary:
SB 7070 creates s. 381.814, F.S., establishing the Sickle Cell Disease Research and Treatment
Grant Program (Program) with the Florida Department of Health (DOH) to fund projects that
improve the quality and accessibility of health care available for persons living with sickle cell
disease (SCD) in the state, as well as advance the collection and analysis of comprehensive data
to support research of SCD.
The bill defines terms, identifies long-term goals of the Program, and establishes how funds
appropriated to the Program may be used for projects specific to SCD. The DOH’s Office of
Minority Health and Health Equity is responsible for awarding grants to community-based SCD
medical treatment and research centers in Florida.
The bill limits the percentage of grant funding used for administrative expenses and authorizes
certain appropriated funds to be carried over for a specified timeframe.
The bill lists the duties of the DOH under the Program, requires an annual report with specific
information be submitted to the Governor, the President of the Senate, and the Speaker of the
House of Representatives, and allows the DOH to adopt rules for Program implementation.
The bill amends s. 383.147, F.S., revising SCD and sickle cell trait screening requirements to
require that screening providers notify a newborn’s parent or guardian, rather than the newborn’s
primary care physician, of certain information. The bill also authorizes individuals, other than
newborns, that have been identified as having SCD or carrying the sickle cell trait, to volunteer
for inclusion on the DOH’s sickle cell registry.
The bill creates s. 456.0311, F.S., requiring the applicable health care practitioner regulatory
boards for specified health care professions to mandate a two-hour continuing education (CE)
course on SCD care management as part of every second biennial licensure or certification
BILL: SB 7070 Page 2
renewal. The bill specifies requirements for the course and the procedure for licensees and
certificate holders to submit course completion confirmation.
The bill authorizes applicable boards to approve additional equivalent courses that may be used
to satisfy the CE course requirement and to include the course hours in the total hours of CE
required for the applicable profession, with an exception. The bill also authorizes health care
practitioners holding two or more licenses or certificates subject to the course requirement to
show proof of completion of one course to satisfy the requirement for all such licenses or
certificates.
The bill provides for disciplinary action and authorizes applicable boards to adopt rules.
The bill may have an indeterminate fiscal impact to the DOH to establish the Program. See
Section V., Fiscal Impact Statement.
The bill provides an effective date of July 1, 2024.
II. Present Situation:
Florida Department of Health
The Florida Department of Health (DOH) is responsible for the state’s public health system,
which is designed to promote, protect, and improve the health of all people in the state.1
Rare Diseases
The federal Orphan Drug Act defines a rare disease as any condition that nationally affects fewer
than 200,000 people. Over 7,000 rare diseases affect more than 30 million people in the U.S.
Many rare conditions are life-threatening and most do not have treatments. Drug, biologic, and
device development in rare diseases is challenging for many reasons, including the complex
biology and the lack of understanding of the natural history of many rare diseases. The inherently
small population of patients with a rare disease can also make conducting clinical trials difficult.2
Since the Orphan Drug Act was signed into law in 1983, the federal Food and Drug
Administration (FDA) has approved hundreds of drugs for rare diseases, but most rare diseases
do not have FDA-approved treatments. The FDA works with many people and groups, such as
patients, caregivers, and drug and device manufactures, to support rare disease product
development. So, while the individual diseases may be rare, the total number of people impacted
by a rare disease is larger.3
Rare diseases include genetic disorders, infectious diseases, cancers, and various other pediatric
and adult conditions. A rare disease can affect anyone at any point in their life, and can be acute
1
Section 381.001, F.S.
2
United States Food and Drug Administration, Rare Diseases at FDA, available at https://www.fda.gov/patients/rare-
diseases-fda (last visited Feb. 16, 2024).
3
Id.
BILL: SB 7070 Page 3
or chronic. It is estimated that 80 percent or more of rare diseases are genetic. For genetic rare
diseases, genetic testing is often the only way to make a definitive diagnosis.4
Rare diseases present a fundamentally different array of challenges compared to those of more
common diseases. Often patients are sent on a “diagnostic odyssey,” in order to determine the
cause of symptoms, seeking treatment in health care settings unfamiliar with such a rare
condition.5
Newborn Metabolic Screening Program
The Legislature created the Florida Newborn Screening Program (NBS Program) in 1965 within
the DOH to promote the screening of all newborns for metabolic, hereditary, and congenital
disorders known to result in significant impairment of health or intellect.6 The NBS Program also
promotes the identification and screening of all newborns in the state and their families for
environmental risk factors (i.e., 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.7
The NBS Program 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.8 The NBS
Program is intended to screen all prenatal women and newborns, however, parents and guardians
may choose to decline the screening.9
Health care providers perform non-laboratory NBS Program 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.10
Health care providers in hospitals and birthing centers perform specimen collection for
laboratory analysis for the NBS Program screening by collecting a few drops of blood from the
newborn’s heel on a standardized specimen collection card.11 The specimen card is then sent to
the state laboratory for testing and the results are released to the newborn’s health care provider.
4
Florida Department of Health, Rare Disease Advisory Council: Legislative Report – Fiscal Year 2022/2023 (2023),
available at https://www.floridahealth.gov/provider-and-partner-resources/rdac/_documents/Rare-Disease-Advisory-Council-
Legislative-Report_2023.pdf (last visited Feb. 16, 2024).
5
Florida Department of Health, Rare Disease Advisory Council: Legislative Report – Fiscal Year 2022/2023 (2023),
available at https://www.floridahealth.gov/provider-and-partner-resources/rdac/_documents/Rare-Disease-Advisory-Council-
Legislative-Report_2023.pdf (last visited Feb. 16, 2024).
6
Section 383.14(1), F.S.
7
Id.
8
Florida Department of Health, Florida Newborn Screening Guidelines, available at
https://floridanewbornscreening.com/wp-content/uploads/NBS-Protocols-2022-FINAL.pdf (last visited Feb. 16, 2024).
9
Section 383.14(4), F.S.; Fla. Admin. Code R. 64C-7.008, (2023). The health care provider must attempt to get a written
statement of objection to be placed in the medical record.
10
Id.
11
Florida Newborn Screening, What is Newborn Screening?, available at
https://floridanewbornscreening.com/parents/whatis-newborn-screening/ (last visited Feb. 16, 2024). See also, Florida
BILL: SB 7070 Page 4
In the event that a newborn screen has an abnormal result, the newborn’s health care
practitioner,12 or a nurse or specialist from the NBS Program’s “Follow-up Program,” provides
follow-up services and referrals for the child and his or her family.13
The newborn screening report includes the screening results for all 58 conditions currently
screened. Newborn screening is part of the standard of care for all infants. Florida law allows for
a parent to opt-out of newborn screening prior to collection. This opt-out is documented in the
medical record maintained by the collection facility. The NBS Program maintains the results of
the newborn screenings, in addition to diagnostic results for newborns identified with a condition
on the screening panel. Data is available from January 2006 forward. The DOH’s retention
schedule requires newborn screening records to be permanently maintained.14
Office of Minority Health and Health Equity
The DOH’s Office of Minority Health and Health Equity (Office) was established by the Florida
Legislature15 to administer the Closing the Gap grant program. The Office evaluates and awards
grants, determines best practices, and maximizes the benefits of grants.16
Closing the Gap Grant Program
The state-funded program, Reducing Racial and Ethnic Health Disparities “Closing the Gap”
(CTG) grant17, supports communities, faith-based entities, and other organizations to eliminate
health disparities. CTG grants fund communities to work with partners to improve the health of
racial and ethnic populations, eliminate barriers, and achieve optimal health in Florida.
Current priority areas for this grant program include:18
Adult and child immunizations;
Alzheimer’s disease and related dementia;
Cancer;
Cardiovascular disease;
Diabetes;
HIV/AIDS;
Newborn Screening, Specimen Collection Card, available at http://floridanewbornscreening.com/wp-content/uploads/Order-
Form.png (last visited Feb. 16, 2024).
12
Current law allows for the screening results to be released to specified health care practitioners including: allopathic and
osteopathic physicians and physician assistants licensed under chs. 458 and 459, F.S., advanced practice registered nurses,
registered nurses, and licensed practical nurses licensed under ch. 464, F.S., a midwife licensed under ch. 467, F.S., a speech-
language pathologist or audiologist licensed under part I of ch. 468, F.S., or a dietician or nutritionist licensed under part X of
ch. 468, F.S.
13
Id.
14
Department of Health, 2024 Agency Legislative Bill Analysis, SB 1582 (Sept. 18, 2023) (on file with the Senate Committee
on Health Policy).
15
Section 20.43, F.S.
16
Florida Department of Health, Office of Minority Health, available at https://www.floridahealth.gov/programs-and-
services/minority-health/index.html (last visited Feb. 19, 2024).
17
Section 381.7356, F.S.
18
Florida Department of Health, Closing the Gap Grant, available at https://www.floridahealth.gov/%5C/programs-and-
services/minority-health/GrantFundingResources/closing-the-gap.html (last visited Feb. 19, 2024).
BILL: SB 7070 Page 5
Lupus;
Maternal and infant mortality;
Oral healthcare;
SCD;
Social determinants of health; and
Severe maternal morbidity.
Sickle Cell Disease
SCD affects approximately 100,000 Americans and is the most prevalent inherited blood
disorder in the U.S.19 SCD affects mostly, but not exclusively, persons of African ancestry. SCD
is a group of inherited disorders in which abnormal hemoglobin cause red blood cells to buckle
into a sickle shape. The deformed red blood cells damage blood vessels and over time contribute
to a cascade of negative health effects beginning in infancy, such as intense vaso-occlusive pain
episodes, strokes, organ failure, and recurrent infections.20,21 The severity of complications
generally worsens with age, but treatment and prevention strategies can mitigate complications
and lengthen the lives of those suffering from SCD.22
A person who carries a single gene for SCD has the sickle cell trait. Individuals with the sickle
cell trait do not have SCD, and under normal conditions they are generally asymptomatic.
However, they are carriers of SCD and have an increased likelihood of having a child with SCD.
It is estimated that eight to ten percent of African Americans carry the sickle cell trait.23
While SCD is the most common inherited blood disorder in the U.S., and is often diagnosed at
birth through newborn screening programs,24 patients with SCD experience many of the other
trials associated with treating a rare disease. Until recently there was very little research
development in the areas of managing, treating, or curing SCD.25,26
19
National Institutes of Health, National Heart, Lung, and Blood Institute, What is Sickle Cell Disease?, available at
https://www.nhlbi.nih.gov/health/sickle-cell-disease (last visited Feb. 16, 2024).
20
Centers for Disease Control and Prevention, What is Sickle Cell Disease? available at
https://www.cdc.gov/ncbddd/sicklecell/facts.html (last visited Feb. 16, 2024).
21
Florida Agency for Health Care Administration, Florida Medicaid Study of Enrollees with Sickle Cell Disease (2023),
available at
https://ahca.myflorida.com/content/download/20771/file/Florida_Medicaid_Study_of_Enrollees_with_Sickle_Cell_Disease.p
df (last visited Feb. 16, 2024).
22
Centers for Disease Control and Prevention, Complications of Sickle Cell Disease, available at
https://www.cdc.gov/ncbddd/sicklecell/complications.html (last visited Feb. 16, 2024).
23
American Society of Hematology, ASH Position on Sickle Cell Trait (2021), available at
https://www.hematology.org/advocacy/policy-news-statements-testimony-and-correspondence/policy-
statements/2021/ashposition-on-sickle-cell-trait (last visited Feb. 16, 2024).
24
Centers for Disease Control and Prevention, Newborn Screening (NBS) Data (2023), available at
https://www.cdc.gov/ncbddd/hemoglobinopathies/scdc-state-
data/newbornscreening/index.html#:~:text=Newborn%20screening%20(NBS)%20for%20sickle,SCD%20living%20in%20a
%20state. (last visited Feb. 16, 2024).
25
American Society of Hematology, ASH Sickle Cell Disease Initiative. available at
https://www.hematology.org/advocacy/sickle-cell-disease-initiative (last visited Feb. 17, 2024).
26
Department of Health, 2024 Agency Legislative Bill Analysis, SB 1582 (Sept. 18, 2023) (on file with the Senate Committee
on Health Policy).
BILL: SB 7070 Page 6
The NBS Program has included screening for SCD since 1988.27
Sickle Cell Disease Registry
In 2023, the DOH was required under s. 383.147, F.S., to contract with a community-based SCD
medical treatment and research center to establish and maintain a registry for newborns and
infants identified as carrying a sickle cell hemoglobin variant. If a screening provider detects that
a newborn or an infant is carrying a sickle cell hemoglobin variant, it must notify the child’s
primary care physician and submit the results to the DOH for inclusion in the sickle cell registry.
The registry must track SCD outcome measures. A parent or guardian of a newborn or an infant
in the registry may request to have his or her child removed from the registry by submitting a
form prescribed by the DOH in rule.28,29
Based on a review of the 2022 provisional data, the DOH identified 137 newborns with SCD and
5,800 with the sickle cell trait. For every newborn identified with the sickle cell trait, notification
letters were sent to both the family and the physician on file for each newborn. NBS Program
results were returned to the