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 Appropriations Committee on Health and Human Services
BILL: SB 7070
INTRODUCER: Appropriations Committee on Health and Human Services
SUBJECT: Sickle Cell Disease
DATE: February 19, 2024
ANALYST STAFF DIRECTOR REFERENCE ACTION
1.
Morgan
McKnight
AHS Submitted as Comm.
Bill/Fav
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
REVISED: 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
Legislature
15
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) grant
17
, 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 submitting provider. It is the responsibility of the submitting entity to
forward the results to the newborn’s primary care provider.
30,31
III. Effect of Proposed Changes:
Section 1 creates s. 381.814, F.S., to establish the Sickle Cell Disease Research and Treatment
Grant Program (Program) within the Florida Department of Health (DOH), and to define the
following terms:
Center of Excellence – a health care facility dedicated to the treatment of patients with sickle
cell disease (SCD), which provides evidence-based, comprehensive, patient-centered
coordinated care consistent with criteria established by the DOH.
Department – the DOH.
Health care practitioner – the same meaning as provided in s. 456.001(4), F.S.
Program – the Sickle Cell Disease Research and Treatment Grant Program.
Sickle cell disease – the group of hereditary blood disorders caused by an abnormal type of
hemoglobin resulting in malformed red blood cells with impaired function, including both
symptomatic manifestations of SCD and the asymptomatic sickle cell trait.
The bill provides the purpose of the Program, which is to fund projects that improve the quality
and accessibility of health care available for persons living with SCD in Florida, as well as to
advance the collection and analysis of comprehensive data to support research of SCD. Long-
term goals of the Program are as follows:
Improve the health outcomes and quality of life for Floridians with SCD.
Expand access to high-quality, specialized care for SCD.
27
Id.
28
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).
29
Department of Health, 2024 Agency Legislative Bill Analysis, SB 1582 (Sept. 18, 2023) (on file with the Senate Committee
on Health Policy).
30
Supra note 28.
31
Supra note 29. BILL: SB 7070 Page 7
Improve awareness and understanding among health care practitioners of current best
practices for the treatment and management of SCD.
Using funds appropriated for the Program, the bill establishes that the DOH’s Office of Minority
Health and Health Equity shall award grants to community-based SCD medical treatment and
research centers in Florida to fund projects specific to SCD in the following project areas:
SCD workforce development and education – such projects include, but are not limited to,
facility-based education programs, continuing education curriculum development, and
outreach and education activities with the local health care practitioner community;
workforce development and education projects must be based on current evidence-based
clinical practice guidelines for SCD.
SCD treatment centers of excellence – such projects include, but are not limited to,
operational support for existing centers of excellence, facility enhancement of existing
centers of excellence, and the establishment of new centers of excellence.
Surveillance and evaluation – such projects include, but are not limited to, the maintenance
of and improvements to an existing SCD and sickle cell trait registry.
The bill provides that a recipient of a grant awarded under the Program may not use more than
five percent of grant funds for administrative expenses. Notwithstanding s. 216.301, F.S., and
pursuant to s. 216.351, F.S., the bill also allows appropriated Program funds from the General
Revenue Fund to be carried forward for up to five years after the effective date of the original
appropriation if not disbursed but obligated pursuant to contract or committed to be expended by
June 30, of the fiscal year in which the funds are appropriated.
Under the bill, duties of the DOH are as follows:
Publicize the availability of funds under the Program and establish the application process for
submitting a grant proposal.
Develop uniform data reporting requirements for the purpose of evaluating the performance
of the grant recipients and demonstrating improved health outcomes.
Develop a monitoring process to evaluate progress toward meeting grant objectives.
The bill requires an annual report be submitted to the Governor, the President of the Senate, and
the Speaker of the House of Representatives by March 1, of each year. At a minimum, the report
must include the status and progress for each project supported by the Program during the
previous calendar year, any recommendations for improving the Program, and all of the
following components for each supported project:
A summary of the project and the project outcomes or expected project outcomes.
The status of the project, including whether it has concluded or the estimated date of
completion.
The amount of the grant awarded and the estimated or actual cost of the project.
The source and amount of any federal, state, or local government grants or donations or
private grants or donations funding the project.
A list of all entities involved in the project.
The bill provides that the DOH may adopt rules to implement the Program.
BILL: SB 7070 Page 8
Section 2 amends s. 383.147, F.S., to revise SCD and sickle cell trait screening requirements,
establishing that a newborn, as defined in s. 383.145(2), F.S., identified as having SCD, or the
sickle cell trait, through the NBS Program, as described in s. 383.14, F.S., must:
Notify the parent or guardian of the newborn and provide information regarding the
availability and benefits of genetic counseling; and
Submit the results of such screening for inclusion in the sickle cell registry, unless the parent
or guardian of the newborn provides an opt-out form obtained from the DOH, or otherwise
indicates in writing to the DOH his or her objection to having the newborn included in the
registry. The DOH must notify such parent or guardian of his or her ability to opt-out.
The bill makes conforming changes to existing statute that provides clarity as to what is meant
by hemoglobin variant, striking this language throughout and replacing with SCD or the sickle
cell trait. Under this bill, other individuals living in Florida that are identified as having SCD or
the sickle cell trait may choose to be included in the sickle cell registry by providing the DOH
with notification as prescribed by rule.
Section 3 creates s. 456.0311, F.S., to require the applicable board of each individual licensed or
certified under ch. 458, 459, or part I of 464, F.S., to complete a two-hour continuing education
(CE) course, approved by the board, on SCD care management as part of very second biennial
licensure or certification renewal. The course shall consist of education specific to SCD and the
sickle cell trait, including, but not limited to, evidence-based treatment guidelines for patients of
all ages, continuing patient and family education, periodic comprehensive evaluations and other
disease-specific health maintenance services, psychosocial care, genetic counseling, and pain
management.
The bill requires that each licensee or certificate holder submit confirmation of having completed
the CE course on a form provided by the applicable board when submitting fees for each second
biennial renewal. The applicable board may approve additional equivalent CE courses, and the
hours required for completion of the CE course may be included in the total hours of CE required
by law for such profession unless the CE requirements consist of fewer than 30 hours biennially.
The bill allows any individual holding two or more licenses, subject to this section, to show
proof of having taken one-board approved course to satisfy requirements for purposes of
licensure or recertification for additional licenses. Failure to comply with the CE requirements
constitutes grounds for disciplinary action under each respective practice act and s.
456.072(1)(k), F.S.
The bill establishes that each applicable board may adopt rules to implement this section.
Section 4 provides an effective date of July 1, 2024.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None. BILL: SB 7070 Page 9
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
None.
E. Other Constitutional Issues:
None.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
The bill may have an indeterminate fiscal impact on individuals licensed or certified
under ch. 458, 459, or part I of 464, F.S., associated with the cost of the sickle cell
disease continuous education course required under the bill.
C. Government Sector Impact:
The bill may have an indeterminate fiscal impact to the Florida Department of Health to
establish the Sickle Cell Disease Research and Treatment Grant Program.
VI. Technical Deficiencies:
None.
VII. Related Issues:
None.
VIII. Statutes Affected:
This bill substantially amends section 383.147 of the Florida Statutes.
This bill creates sections 381.814 and 456.0311 of the Florida Statutes. BILL: SB 7070 Page 10
IX. Additional Information:
A. Committee Substitute – Statement of Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
None.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.