This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives.
STORAGE NAME: h1481.HRS
DATE: 3/21/2023
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: HB 1481 Review and Report on Sickle Cell Disease Medications, Treatments, and Services
for Medicaid Recipients
SPONSOR(S): Driskell
TIED BILLS: IDEN./SIM. BILLS:
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
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, including detailed information on:
Age and population demographics;
Utilization patterns and expenditures for all pharmaceutical and medical 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, 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 to individuals with SCD.
HB 1481 requires AHCA to biannually review and report the same information it was required to report by the
2022-GAA. Additionally, it requires AHCA to assess their existing 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.
The bill authorizes $250,000 in nonrecurring funds from the General Revenue Fund to AHCA. The bill has no
fiscal impact on local government.
The bill provides an effective date of July 1, 2023.
STORAGE NAME: h1481.HRS PAGE: 2
DATE: 3/21/2023
FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED 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 is a disease that gets worst 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
AHCA 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 School
Quality Network and a dedicated SCD medical treatment and research center that maintains a sickle
cell patient database and tracks SCD outcome measures, to conduct a review and publish a report of
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 March 20, 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 March 20, 2023).
3
Id.
4
CDC, What is Sickle Cell Disease?, available at https://www.cdc.gov/ncbddd/sicklecell/facts.html (last visited March 20, 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. STORAGE NAME: h1481.HRS PAGE: 3
DATE: 3/21/2023
its findings on the availability and utilization of specific services for Medicaid enrollees diagnosed with
SCD.
11
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.
12
Age and 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. The SCD
population was predominantly female (58%), young (median age 18), and black (63%). Geographically,
the highest number of 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. 61 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. 52 percent of enrollees with SCD were admitted for
inpatient care in a hospital, and those enrollees had 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.
13
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
Medication Utilization by Eligible Individuals with SCD
Medication
Number Eligible to
Receive Medication
Number of 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%
Managed Care Clinical Treatment Programs for SCD
11
Ch. 2022-156, Laws of Fla.
12
Supra note 2.
13
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 March 20, 2023). STORAGE NAME: h1481.HRS PAGE: 4
DATE: 3/21/2023
The report identified 72 clinical treatment programs who 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. According to the report, in addition to these clinical treatment programs,
hematopoietic cell transplant programs at the University of Miami, H. Lee Moffitt Cancer Center, the
University of Florida, and others have transplanted autologous or allogeneic adult blood stem cells to
patients with SCD to introduce a new blood system free of sickle shaped red blood cells. Further, in
2023, these transplant centers may also offer new FDA approved gene therapies for people with SCD
that have the potential to cure SCD. These treatments are estimated to cost $1 million to $2 million per
person and are only available at a limited number of transplant centers.
Effect of the Bill
HB 1481 requires AHCA, in consultation with the Florida Medical School 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 2022-GAA. Additionally, it requires AHCA to assess their existing 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.
The bill authorizes $250,000 in nonrecurring funds from the General Revenue Fund to AHCA to
conduct the review develop the report.
The bill provides an effective date of July 1, 2023.
B. SECTION DIRECTORY:
Section 1: Creates s. 409.91235, F.S., relating to agency review and report on medications,
treatments, and services for sickle cell disease.
Section 2: Provides an appropriation.
Section 3: 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:
The bill authorizes $250,000 in nonrecurring funds from the General Revenue Fund to AHCA to
conduct the review and develop the report. This is the same amount that AHCA received in 2022,
which it used to contract for the completion of the report. The bill requires the report to be
conducted biannually. If AHCA were to contract for the completion of the biannual report, it would
cost $1.25 million every ten years.
B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
1. Revenues:
None.
2. Expenditures:
None.
C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR: STORAGE NAME: h1481.HRS PAGE: 5
DATE: 3/21/2023
None.
D. FISCAL COMMENTS:
None.
III. COMMENTS
A. CONSTITUTIONAL ISSUES:
1. Applicability of Municipality/County Mandates Provision:
Not applicable. The bill does not appear to affect county or municipal governments.
2. Other:
None.
B. RULE-MAKING AUTHORITY:
No rule-making authority is necessary to implement the provisions of the bill.
C. DRAFTING ISSUES OR OTHER COMMENTS:
None.
IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES