This document does not reflect the intent or official position of the bill sponsor or House of Representatives.
STORAGE NAME: h1481z.DOCX
DATE: 5/3/2023
HOUSE OF REPRESENTATIVES STAFF FINAL BILL ANALYSIS
BILL #: CS/CS/CS/HB 1481 Sickle Cell Disease Medications, Treatment, and Screening
SPONSOR(S): Health & Human Services Committee and Health Care Appropriations Subcommittee and
Healthcare Regulation Subcommittee, Driskell and others
TIED BILLS: IDEN./SIM. BILLS: CS/CS/SB 1352
FINAL HOUSE FLOOR ACTION: 116 Y’s
0 N’s GOVERNOR’S ACTION: N/A
SUMMARY ANALYSIS
CS/CS/CS/HB 1481 passed the House on May 3, 2023, as CS/CS/SB 1352.
Sickle cell disease (SCD) is an inherited disease caused by abnormal hemoglobin in red blood cells, which
causes the red blood cells to become hard and sticky making them prone to clogging the flow of blood. This
can lead to episodes of pain or other health problems such as strokes, organ failure, eye problems, and
infections. It affects 100,000 people nationwide, 90 percent of which are people of African descent.
In 2022, the General Appropriations Act (GAA) included nonrecurring funds for the Agency for Health Care
Administration (AHCA) to conduct a review and publish a report of its findings on the availability and utilization
of specific services for Medicaid enrollees diagnosed with SCD.
The report, which was published on February 1, 2023, used information from 2018 through 2021 on Medicaid
enrollees with SCD to produce the following results:
On average, 7,328 Medicaid enrollees have SCD, which is twice as high as the national average;
Enrollees are predominantly female (58%), young (median age 18), and black (63%);
85 percent were evaluated or treated in an outpatient clinic setting; 61 percent were evaluated in an
emergency room; and 52 percent were admitted for inpatient care in a hospital;
Stroke screening for children with transcranial doppler ultrasound was only performed at half the rate
recommended by national guidelines; and
72 clinical treatment programs contract with managed care plans to provide care for individuals with SCD.
The bill codifies the GAA report obligation, requiring AHCA to biannually review and report the same
information. Additionally, it requires AHCA to assess existing Medicaid payment methodologies for approved
SCD treatments and medications in the inpatient setting and whether such payment methodologies result in
barriers to access. If AHCA identifies barriers to access, AHCA must assess whether the payment
methodologies may be modified or improved.
The bill requires the Department of Health (DOH) to contract with a community-based sickle cell disease
medical treatment and research center to establish and maintain a registry to track outcome measures of
newborns who are identified as carrying a sickle cell hemoglobin variant. The bill requires a screening provider
to notify the primary care physician of an infant who tests positive for sickle cell hemoglobin variant and to
submit the results of the screening to DOH for inclusion in the sickle cell registry. The primary care physician
must provide information on the availability and benefits of genetic counseling to the parent or guardian of the
newborn.
The bill appropriates $1,060,804 in recurring funds, $21,355 in nonrecurring funds, and five full time employee
positions to DOH, and $250,000 in nonrecurring funds to AHCA, to implement the bill. The bill has no fiscal
impact on local government.
Subject to the Governor’s veto powers, the effective date of this bill is July 1, 2023.
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DATE: 5/3/2023
I. SUBSTANTIVE INFORMATION
A. EFFECT OF CHANGES:
Background
Sickle Cell Disease
Sickle cell disease (SCD) is the most common inherited blood disorder in the United States—
approximately 100,000 Americans have SCD.
1
It is caused by a mutation in the hemoglobin-Beta gene
called HbS. When a child inherits HbS from only one parent, the person may have sickle cell trait,
which means they are a carrier of SCD, thus increasing the chance of having a child with SCD if they
have a child with another carrier.
2
When both parents have SCD, there is a 25 percent chance their
child will have SCD. A child from those same parents also has a 50 percent chance of inheriting sickle
cell trait and a 25 percent chance of no sickle cell inheritance.
3
Hemoglobin transports oxygen from the lungs to other parts of the body. Red blood cells with normal
hemoglobin are smooth and round and glide through blood vessels. In people with SCD, abnormal
hemoglobin molecules stick to one another and form long, rod-like structures. These structures cause
red blood cells to become stiff, assuming a sickle shape, which causes them to pile up and create
blockages that can damage vital organs and tissue.
4
SCD can also cause fatigue, which is why it is
sometimes called sickle cell anemia.
5
Diagnosis and Treatment
All newborns in Florida are screened within 1 week after birth for SCD.
6
It can also be diagnosed
prenatally by using diagnostic tests that identify chromosomal or genetic abnormalities.
7
SCD gets worse over time, but treatments exist that can prevent complications and lengthen the lives
of people with SCD. Oral penicillin is the standard of care for children with SCD because chronic
damage to the spleen increases the risk of life-threatening pneumococcal bacterial infection.
8
The only
therapy approved by the FDA that may be able to cure SCD is a bone marrow or stem cell transplant.
9
These treatments are estimated to cost $1 million to $2 million per person and are only available at a
limited number of transplant centers.
10
Florida Medicaid Report on Sickle Cell Disease
In 2022, the Legislature appropriated $250,000 in nonrecurring funds from the General Revenue Fund
to the Agency for Health Care Administration (AHCA), in consultation with the Florida Medical Schools
Quality Network
11
and a dedicated SCD medical treatment and research center that maintains a sickle
1
National Heart, Lung, and Blood Institute, What is Sickle Cell Disease?, available at https://www.nhlbi.nih.gov/health/sickle-cell-
disease (last visited May 11, 2023).
2
AHCA, Florida Medicaid Study of Enrollees with Sickle Cell Disease, February 1, 2023, available at
https://ahca.myflorida.com/content/download/20771/file/Florida_Medicaid_Study_of_Enrollees_with_Sickle_Cell_Disease.pdf (last
visited May 11, 2023).
3
Id.
4
CDC, What is Sickle Cell Disease?, available at https://www.cdc.gov/ncbddd/sicklecell/facts.html (last visited May 11, 2023).
5
Id.
6
S. 383.14(2), F.S., and rule 64C-7.002, F.A.C.
7
Supra note 4.
8
Supra note 2, at 10-12. Hydroxyurea is the standard of care for people as young as 9 months old; L-Glutamine is recommended for
adults and children age 5 and older; Voxelotor is recommended for adults and children age 4 and older; Crizanlizumab is recommended
for people age 16 and older; and opioids and iron chelating agents are also often used.
9
Supra note 4.
10
Supra note 2.
11
The Florida Medical Schools Quality Network is an organization of nine participating medical schools contracted by AHCA to to
improve clinical outcomes in managed care plans. Contracted activities must support greater clinical integration for Medicaid enrollees
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DATE: 5/3/2023
cell patient database and tracks SCD outcome measures,
12
to conduct a review and publish a report of
its findings on the availability and utilization of specific services for Medicaid enrollees diagnosed with
SCD.
13
Specifically, the report was required to include detailed information on:
Age and population demographics;
Utilization patterns and expenditures for all medical and pharmaceutical services provided; and
The number of clinical treatment programs who contract with managed care plans and are
specifically designed or certified to provide care to individuals with SCD.
The report was published on February 1, 2023, and the results were based on data gathered between
2018 through 2021 on Medicaid enrollees with SCD.
14
Population Demographics
The average number of Medicaid enrollees with SCD is 7,328, which is twice as high as the national
average. Florida and New York have the highest number of Medicaid recipients with SCD. According to
the report, the SCD population is predominantly female (58%), young (median age 18), and black
(63%). Geographically, the highest number of Florida Medicaid enrollees with SCD live in central and
south Florida.
Utilization of Medical and Pharmaceutical Services
Nearly all enrollees with SCD were evaluated by a physician at least once and approximately 85
percent were evaluated or treated in an outpatient clinic setting at least once. Sixty-one percent were
evaluated and treated in an emergency room at least once, and those with an emergency room visit
had an average of 4.5 visits from 2018 to 2021. Fifty-two percent of enrollees with SCD were admitted
for inpatient care in a hospital, with an average of 2.9 inpatient admissions from 2018 to 2021.
National guidelines recommend that children with SCD aged 2-16 should have an annual transcranial
doppler ultrasound (TCD) to screen for stroke risk.
15
Florida Medicaid child enrollees had an average of
two TCDs over the four-year reporting period, which was below the recommended four TCDs for that
period.
Data on medication utilization indicated that 77 percent of Medicaid enrollees with SCD had a
pharmacy expenditure for a sickle cell disease-relevant medication, including disease-modifying
treatments, prophylactic antibiotics, opioids, or iron chelating agents.
through interdependent and cooperative efforts of all providers. See s. 409.975(2), F.S., see also Florida Medical Schools Quality
Network, available at https://www.fmsqn.org/ (last visited May 11, 2023).
12
AHCA contracted with the Sickle Care and Research Network, which is a dedicated SCD medical treatment and research center in
Hollywood, Florida that maintains a sickle cell patient database and tracks SCD outcome measures.
13
Ch. 2022-156, Laws of Fla.
14
Supra note 2.
15
National Heart, Lung, and Blood Institute, Evidence-Based Management of Sickle Cell Disease: Expert Panel Report, 2014, available
at https://www.nhlbi.nih.gov/health-topics/evidence-based-management-sickle-cell-disease (last visited May 11, 2023).
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DATE: 5/3/2023
Medication Utilization by Eligible Individuals with SCD
16
Medication
Patients Eligible
for Medication
Patients Taking
Medication
Percent of Eligible
Population Taking
Medication
Oral Penicillin 2,054 1,197 58%
Hydroxyurea 7,613 1,691 22%
L-glutamine 6,840 154 2%
Voxelotor 5,629 8 0.1%
Crizanlizumab 4,956 4 0.8%
Medicaid Managed Care Clinical Treatment Programs for SCD
The report identified 72 clinical treatment programs that contract with managed care plans to provide
care to individuals with SCD. They include as little as one treatment program offered by a managed
care plan to as many as 23, depending on the size and population focus of the plan.
17
Effect of the Bill
Florida Medicaid Report on Sickle Cell Disease
The bill requires AHCA, in consultation with the Florida Medical Schools Quality Network and a
dedicated SCD medical treatment and research center that maintains a sickle cell patient database and
tracks SCD outcome measures, to biannually review and report the same information it was required to
report by the Fiscal Year 2022-23 GAA. Additionally, it requires AHCA to assess existing Medicaid
payment methodologies for approved SCD treatments and medications in the inpatient setting and
whether such payment methodologies result in barriers to access. If barriers to access are identified,
AHCA must assess whether the payment methodologies may be modified or improved.
Sickle Cell Registry
The bill requires the Department of Health (DOH) to contract with a community-based sickle cell
disease medical treatment and research center to establish and maintain a registry to track outcome
measures of newborns who are identified as carrying a sickle cell hemoglobin variant. The bill requires
a screening provider to notify the primary care physician of an infant who tests positive for sickle cell
hemoglobin variant and to submit the results of the screening to DOH for inclusion in the sickle cell
registry. The primary care physician must provide information on the availability and benefits of genetic
counseling to the parent or guardian of the newborn.
The bill requires DOH to establish a system to ensure that the sickle cell research center notifies the
parent or guardian of a child included in the registry that a follow-up consultation with a physician is
recommended, at least once during early adolescence and once during late adolescence. The bill also
requires DOH to provide individuals who are 18 years of age and that are included in the registry with
information regarding available educational services, genetic counseling, and other beneficial
resources.
The bill provides rulemaking authority to DOH to create the registry and requires DOH to adopt rules to
establish a process for removing individuals from the registry.
The bill provides an effective date of July 1, 2023.
16
Supra note 2, at 10.
17
Supra note 2, at 17.
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DATE: 5/3/2023
II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT
A. FISCAL IMPACT ON STATE GOVERNMENT:
1. Revenues:
None.
2. Expenditures:
The 2023-24 General Appropriations Act (GAA)
18
authorizes the unexpended balance of funds
provided to AHCA for the Sickle Cell Disease Medicaid Study by the 2022-23 GAA
19
($250,000
nonrecurring) to revert for the purpose of conducting the study and report as required by the bill.
The bill requires the report to be conducted biannually. If AHCA were to contract for the biannual
reports, it would cost $1.25 million every ten years.
The bill also appropriates $1,060,804 in recurring funds, $21,355 in nonrecurring funds, and five full
time employee positions, to DOH to implement the SCD registry required by the bill.
B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
1. Revenues:
None.
2. Expenditures:
None.
C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
None.
D. FISCAL COMMENTS:
None.
18
2023 Florida Legislature, SB 2500 Enrolled, s. 72 (May 5, 2023).
19
Ch. 2022-156, s. 3, at 189, Laws of Fla.