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: HB 5303
INTRODUCER: Health Care Appropriations Subcommittee and Representative Garrison
SUBJECT: Biomedical Research
DATE: April 24, 2023
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Howard Sadberry AP Pre-meeting
I. Summary:
HB 5303 conforms law to the General Appropriations Act (GAA) proposed by the House of
Representatives for Fiscal Year 2023-2024. The bill:
Expands those cancer centers eligible for funding pursuant to the Casey DeSantis Cancer
Research Program (DeSantis program) to include cancer centers designated by the National
Cancer Institute as a comprehensive cancer center with at least one geographic site in
Florida.
Adds qualified uses to cancer research funding.
Exempts $37,771,257 from the annual allocation fraction calculation for participating cancer
centers in the DeSantis program and distributes those funds to participating cancer centers
using the proportion as determined by the calculation.
Eliminates authorization for the endowed research chair contained within the Bankhead-
Coley Cancer Research Program.
Expands eligible programs for funding from the Biomedical Research Trust Fund to include
“other cancer research initiatives as appropriated by the Legislature.”
The bill takes effect on July 1, 2023.
II. Present Situation:
Cancer is the general name for a group of more than 100 diseases. Although there are many
kinds of cancer, all cancers start because abnormal cells grow out of control. Untreated cancers
can cause serious illness and death. Cancer affects one in three people in the United States.
1
About 1,958,310 new cancer cases are expected to be diagnosed in 2023 in the United States,
with approximately 162,410 of those occurring in Florida. In 2023, about 609,820 Americans are
1
American Cancer Society, What is Cancer, available at: http://www.cancer.org/cancer/cancerbasics/what-is-cancer (last
visited March 9, 2023).
REVISED: BILL: HB 5303 Page 2
expected to die of cancer, almost 1,670 people per day.
2
Cancer is the second most common
cause of death in the United States, exceeded only by heart disease, accounting for nearly one of
every four deaths. The National Cancer Institute estimates that approximately 17 million
Americans with a history of cancer were alive on June 11, 2019. Some of these individuals were
cancer free, while others still had evidence of cancer and may have been undergoing treatment.
3
Cancer is the second leading cause of death in Florida.
4
Florida has the second-highest number of
newly-diagnosed cancer cases in the U.S., despite being the fourth-largest state in terms of
population. According to the American Cancer Society, breast cancer is the most common cancer
for women in the United States.
5
In 2019, the year for which the most recent statistics are
available, breast cancer was the third leading cause of cancer-related death in Florida.
6
The National Cancer Institute
The National Cancer Institute (NCI) is the federal government's principal agency for cancer
research and training.
7
One function of the NCI is to designate cancer centers by recognizing an
institution for the type and breadth of research conducted in addition to the leadership and
resources that the cancer center offers. Such designation is nationally recognized as a marker of
high-quality cancer care and research. The NCI designates institutions as:
8
Comprehensive Cancer Centers – focused on substantial transdisciplinary research that
bridges all cancer-related research areas;
Cancer Centers – focused on one research area such as clinical, prevention, cancer control or
population science research; or
Basic Laboratory Cancer Centers - focused on laboratory research and work collaboratively
with other institutions.
Currently, there are two NCI-designed comprehensive cancer centers in Florida: Mayo Clinic
Cancer Center Jacksonville, Florida, (in addition to facilities in Arizona and Minnesota); and, H.
Lee Moffitt Cancer Center. A third, University of Miami Sylvester Comprehensive Cancer
2
American Cancer Society, Incidence Drops for Cervical Cancer Drop but Rises for Prostate Cancer, available at:
https://www.cancer.org/latest-news/facts-and-figures-
2023.html#:~:text=Cancer%20continues%20to%20be%20the,about%201%2C670%20deaths%20a%20day (last visited March
18, 2023).
3
American Cancer Society, Cancer Facts and Figures 2023, available at: https://www.cancer.org/content/dam/cancer-
org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2023/2023-cancer-facts-and-figures.pdf (last visited
March 9, 2023).
4
Florida Vital Statistics, Annual Report 2021- Deaths, available at:
http://www.flpublichealth.com/VSbook/PDF/2021/VSCOMP.pdf (last visited March 9, 2023).
5
American Cancer Society, Key Statistics for Breast Cancer, available at: https://www.cancer.org/cancer/breast-
cancer/about/how-common-is-breast
cancer.html#:~:text=Trends%20in%20breast%20cancer%20deaths&text=The%20chance%20that%20a%20woman,decline%2
0of%2043%25%20through%202020 (last visited March 18, 2023).
6
Florida Statewide Cancer Registry, Florida Cancer Data System, Number of Cancer Deaths by Sex, Race and Age Group,
Florida 2019, available at:
https://fcds.med.miami.edu/downloads/FloridaAnnualCancerReport/2019/Table_No_T15_(2019).pdf.
7
National Cancer Institute, National Cancer Institute Overview and Mission, available at: https://www.cancer.gov/about-
nci/overview (last visited March 18, 2023).
8
National Cancer Institute, NCI-Designated Cancer Centers, available at:
https://www.cancer.gov/research/infrastructure/cancer-centers (last visited March 18, 2023). BILL: HB 5303 Page 3
Center, is an NCI-designated cancer center.
9
The University of Florida Shands Cancer Hospital
is currently in process of applying for NCI designation.
The Casey DeSantis Cancer Research Program
In 2014, the Legislature created the Florida Consortium of National Cancer Institute Centers
Program, renamed the Casey DeSantis Cancer Research Program (DeSantis program) in 2022.
10
Established to: enhance the quality and competitiveness of cancer care in Florida; further a
statewide biomedical research strategy directly responsive to the health needs of Florida’s
citizens; and, capitalize on potential educational opportunities available to students, the program
funds Florida-based,
11
NCI-designated cancer centers according to a statutory formula.
12
A participating cancer center’s annual allocation is determined by multiplying the funds
appropriated for the DeSantis program in the General Appropriations Act by an allocation
fraction calculation determined by the Department of Health (DOH).
13
The DOH must calculate
a participating cancer center’s allocation fraction on or before September 15 each year using a
specific statutory formula.
14
The program sets a floor of funding at $16 million in cases where a
participating cancer center’s allocation equals less. The difference is made up using funds
proportionally redistributed from other participating cancer centers’ allocations.
15
A participating cancer center’s allocation fraction calculation is determined by DOH using a tier-
weighted formula that factors in a cancer center’s reportable cancer cases; peer-review costs; and
biomedical education and training.
16
The tier designations that weight DOH’s annual allocation
calculation are based on the participating cancer center’s NCI-designation status. The program’s
three tier designations are:
17
Tier 1: Florida-based NCI-designated comprehensive cancer centers;
Tier 2: Florida-based NCI-designated cancer centers; and
Tier 3: Florida-based cancer centers seeking NCI-designation as well as meeting additional
criteria related to their research and biomedical education.
Currently, three cancer centers participate in the program:
H. Lee Moffitt Cancer Center, which is an NCI-designated comprehensive cancer center;
Sylvester Comprehensive Cancer Center at the University of Miami, which is an NCI-
designated cancer center; and
The University of Florida Health Cancer Center, which is pursuing an NCI-designation.
9
National Cancer Institute, NCI-Designated Cancer Centers, “Find a Cancer Centers” directory, available at:
https://www.cancer.gov/research/infrastructure/cancer-centers/find (last visited March 18, 2023).
10
Section 381.915, F.S.
11
“Florida-based” means that a cancer center’s actual or sought designated status is or would be recognized by the NCI as
primarily located in Florida and not in another state. Section 381.915(3)(c), F.S.
12
Section 381.915(6), F.S. Distributions pursuant to the DeSantis program are subject to annual appropriation by the
Legislature.
13
Id.
14
Section 381.915(3), F.S.,
15
Supra, note 12.
16
Section 381.915(5), F.S.
17
Section 381.915(4), F.S. BILL: HB 5303 Page 4
During the 2022 Legislative Session, the Legislature appropriated an additional $37,771,257 to
the DeSantis program, bringing the total appropriation to $100 million. The funds were required
to be excluded from the statutory distribution formula and be distributed in the same proportion
as required to be allocated to each participating cancer center under the allocation fraction
calculation.
18
Participating cancer centers are required to work with DOH to prepare and submit a report to the
Cancer Control and Research Advisory Council which includes specific metrics relating to
cancer mortality and external funding for cancer-related research in the state. If a participating
cancer center does not endorse this report or produce an equivalent independent report, the
cancer center shall be suspended from the DeSantis program for one year. Among other
elements, the report must include an analysis of specific trending age-adjusted cancer mortality
rates in the state for: lung cancer; pancreatic cancer; sarcoma; melanoma; leukemia and
myelodysplastic syndromes; and, brain cancer.
Biomedical Research in Florida
The Biomedical Research Trust Fund consists of funds appropriated by the Legislature for the
James and Esther King Biomedical Research Program, the Casey DeSantis Cancer Research
Program (DeSantis program), and the William G. “Bill” Bankhead, Jr., and David Coley Cancer
Research Program (Bankhead-Coley program) as specified in ss. 215.5602, 381.915, and
381.922, F.S., respectively. Currently, $37.3 million is annually appropriated from the
Biomedical Research Trust Fund for these programs.
Created in 2006, the Bankhead-Coley program within the DOH funds research grants for
progress towards cures for cancer that attract new talent and increase participation in clinical
trials. Emphasis is given to efforts that significantly expand cancer research capacity in the
state.
19
One element of the Bankhead-Coley program, endowments to cancer research institutions, are
provided to establish a funded research chair that will attract and retain a promising researcher in
order to serve as a catalyst to attract other national grant-producing researchers to the state. The
endowments are contingent upon funding in the General Appropriations Act (GAA). The
purpose of the endowment is to provide secure funding for at least seven years to attract an
experienced and promising researcher whose continued employment for this period is not
contingent upon grant awards associated with time-limited research projects.
20
The research institution that receives an endowed chair must submit an annual report to the
Governor, the President of the Senate and Speaker of the House of Representatives describing
the research program and the responsibilities of the endowed chair. Upon final selection of the
researcher, or if a replacement is needed for the original endowed chair, the research institution
must notify the Chairs of the Appropriations Committees of the Senate and House of
18
Section 29 of Chapter 2022-157, Laws of Florida.
19
Section 381.922(2), F.S.
20
Section 381.322(4), F.S. BILL: HB 5303 Page 5
Representatives of the name of the researcher and specific information about the endowment
budget and research responsibilities.
21
In Fiscal Year 2022-2023, the Legislature appropriated $6 million from the General Revenue
Fund, of which $1 million is nonrecurring, for the endowed chair in the Bankhead-Coley
program.
Florida Cancer Innovation Fund
On February 1, 2023, Governor Ron DeSantis, released the “Framework for Freedom” proposed
budget for Fiscal Year 2023-2024 and included the establishment of the Florida Cancer
Innovation Fund within the Biomedical Research Trust Fund to support innovative cancer
research in the state.
According to the Governor’s proposed budget document:
22
Florida takes a comprehensive approach in implementing cancer control
efforts to reduce the disparities, morbidity and mortality associated with
this disease. The efforts in Florida are guided by several collaborations
such as The Florida Cancer Plan, The Biomedical Research Advisory
Council's Strategic Research and Goals, State Cancer Councils, The
Florida Comprehensive Cancer Control Program, and Region Cancer
Control Collaborative Strategic Plans. Funding cancer research initiatives
is a priority for Florida, with state funding levels reaching a record level of
$149.4 million in Fiscal Year 2022-2023.
Even though Florida has made progress with its efforts, there is room for
improvement in multiple areas and for multiple cancer types. The Florida
Cancer Innovation Fund will fund grants to support emerging research and
trends and promising practices that can be replicated and expanded upon
in Florida.
III. Effect of Proposed Changes:
The bill expands the Casey DeSantis Cancer Research Program to include an NCI-designated
comprehensive cancer center with at least one geographic site in Florida as an entity that may
qualify for funding according to the statutory formula. The bill clarifies that a consortium that
has achieved NCI-designation, or is in the process of doing, must be Florida-based to qualify for
Tier 3 weight in the calculation for the formula. A consortium must achieve the NCI designation
by June 30, 2024, to continue participation in the program. The bill adds breast cancer to the
types of cancer included in the mortality rate report produced by participating cancer centers.
21
Id.
22
Governor Ron DeSantis, Framework for Freedom Budget, HEALTH > COMMUNITY PUBLIC HEALTH (Program) >
COMMUNITY HEALTH PROMOTION > FLORIDA CANCER INNOVATION FUND, available at :
http://frameworkforfreedombudget.com/web%20forms/Budget/BudgetIssueDetail.aspx?p=Cancer%20Innovation&AgencyTitle
=HEALTH%20%3E%20COMMUNITY%20PUBLIC%20HEALTH%20(Program)%20%3E%20COMMUNITY%20HEALTH%20P
ROMOTION%20%3E%20&si=64200100&pc=1602000000&icd=6200140&title=FLORIDA%20CA NCER%20INNOVATION%20
FUND (last visited March 18, 2023). BILL: HB 5303 Page 6
The bill excludes from the allocation fraction calculation $37,771,257 out of the total annual
appropriation for the DeSantis program in the GAA. Those funds shall be distributed to
participating cancers centers using the proportion as determined by the calculation.
Contained within the Bankhead-Coley program is a separately funded endowed research chair.
The bill eliminates authorization for this research chair.
The bill authorizes funding for “other cancer research initiatives as appropriated by the
Legislature” within the Biomedical Research Trust Fund.
The bill takes effect July 1, 2023.
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.
E. Other Constitutional Issues:
None.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
None.
C. Government Sector Impact:
HB 5303 expands the Casey DeSantis Cancer Research Program to include participation
from an NCI-designated comprehensive center with at least one geographical site in BILL: HB 5303 Page 7
Florida requires additional funding to ensure current cancer center participants in the
DeSantis program are not negatively impacted by including a new cancer center. The
estimated cost of including a new cancer center is approximately $27.5 million.
The additional funding of $37,771,257 provided during Fiscal Year 2022-2023 will
continue to be excluded from the statutory distribution formula and will be distributed in
the same proportion as required to be allocated to each participating cancer center in s.
381.915, Florida Statutes.
The removal of the endowed cancer research chair in the Bankhead-Coley program will
result in the elimination of $5 million in recurring funds. Funds may be used to support
expansion of the DeSantis program.
The expansion of eligible programs for funding from the Biomedical Research Trust
Fund to include “other cancer research initiatives” will result in additional recurring
funds of $20 million.
VI. Technical Deficiencies:
None.
VII. Related Issues:
None.
VIII. Statutes Affected:
This bill substantially amends the following sections of the Florida Statutes: 20.435, 381.915,
and 381.922.
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.