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 Health Policy
BILL: CS/SB 1010
INTRODUCER: Health Policy Committee and Senator Gibson
SUBJECT: Uterine Fibroid Research and Education
DATE: February 2, 2022
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Rossitto-Van
Winkle
Brown
HP
Fav/CS
2. AHS
3. AP
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/SB 1010 requires the Department of Health (DOH) to develop and maintain an electronic
database of information related to uterine fibroids. The bill requires specified health care
providers to submit to the DOH information on the diagnosis or treatment of women with uterine
fibroids for inclusion in the database. The bill defines health care providers as physicians
licensed under chs. 458 or 459, F.S., and autonomous advanced practice registered nurses
(AAPRNs) licensed under s. 464.0123, F.S.
The bill prohibits the database from including personal identifying information. The information
collected is confidential and may be used only by DOH employees or agents for the purpose of
conducting research on uterine fibroids. The bill requires the DOH to develop and include
information related to uterine fibroids in literature on women’s health care which is currently
made available to the public, to increase public awareness of uterine fibroids. The information
must include possible risk factors for developing uterine fibroids and the range of available
treatment options that are considered alternatives to a hysterectomy.
The bill provides an effective date of July 1, 2022.
REVISED: BILL: CS/SB 1010 Page 2
II. Present Situation:
The Department of Health
The Legislature created the DOH to protect and promote the health of all residents and visitors in
the state.
1
The DOH is charged with the regulation of health care practitioners for the
preservation of the health, safety, and welfare of the public. The Public Health Research Unit is
located within the Division of Community Health Promotion within the DOH.
2
Public Health Research
In 1999, the Legislature established the Lawton Chiles Endowment Fund and the Florida
Biomedical Research Program to support research initiatives that address the health care
problems of Floridians in the areas of cancer, cardiovascular disease, stroke, and pulmonary
disease.
3
The Biomedical Research Program, within the division of Public Health Research in the
DOH, administers annual funding opportunities for research grant applications, monitors
research grants, evaluates progress of research grant project aims, and provides research
consultations and technical assistance. Annual reports are submitted to the Florida Legislature on
research progress. The goals of the research grants are to find new discoveries leading to the
prevention, treatment, and cures for cancer, tobacco-related diseases, and Alzheimer’s disease.
This program is also responsible for the DOH Institutional Review Board (IRB) and the Human
Research Protection Program, which provides research consultations and technical assistance
concerning applications for research reviewed by the IRB. The IRB reviews research projects
that involve clients, data, facilities, and staff.
The Biomedical Research Program also provides two educational programs to enrich the DOH’s
internal research capacity: the Research Excellence Initiative and Florida Health Grand Rounds.
The Research Excellence Initiative is a year-long education program for DOH professionals
conducting research, epidemiology, and program evaluation. The initiative builds skills and
ability for quality and innovative research with emphasis on research integrity, research ethics,
and regulatory requirements. The Research Excellence Initiative is now in its fourth year.
4
The Florida Health Grand Rounds is a webinar series held in the Fall and Spring semesters in
partnership with Florida university-based researchers and hosted by the DOH. The topics have a
broad focus, touching on emerging, innovative, and cross-cutting areas of public health. Florida
Health Grand Rounds provides an opportunity for Florida researchers to highlight and share their
work with DOH staff.
5
1
Section 20.43, F.S.
2
Id.
3
Chapter 99-167, s. 2, Laws of Fla.
4
Department of Health, Provider and Partner Resources, Research, Research Excellence Initiative, available
athttp://www.floridahealth.gov/provider-and-partner-resources/research/academy-of-research-excellence.html (last visited
Jan. 25, 2022).
5
. Department of Health, Provider and Partner Resources, Research, Florida Health Grand Rounds, available at
http://www.floridahealth.gov/provider-and-partner-resources/research/florida-health-grand-rounds/index.html (last visited
Jan. 25, 2022). BILL: CS/SB 1010 Page 3
Biomedical Research Program
The Florida Legislature has long recognized the need to support vital research conducted in both
academic and private institutions throughout the state through the William G. “Bill” Bankhead
Jr. and David Coley Cancer Research Program (Bankhead-Coley Program); the James and Esther
King Biomedical Research Program (King Program); and the Live Like Bella Pediatric Cancer
Research Initiative (Bella Initiative), the latter of which is funded through the Bankhead-Coley
Program, is now in its fifth year, and is the only state-funded pediatric cancer research program
in the U.S.
6
Total funding, in the amount of $18,505,007, was awarded to Bankhead-Coley and King
program and Bella Initiative grantees. This funding during fiscal year (FY) 2020-21, resulted in
13 Bankhead-Coley, 12 King, and 11 Bella Initiative new research grants. These awards are
made to universities and cancer research centers across the state to support researchers for
improving prevention, diagnosis, and treatment.
7
Research grants are awarded through a competitive peer review process. Awards are based
on scientific merit as determined via independent peer review by experts located outside
Florida who are free from conflicts of interest. Full-time researchers at any Florida-based
university or established research institution are eligible to apply. All researchers provide a
legislative report that is used to produce an annual report.
8
James and Esther King Biomedical Research Program
In 1999 the Legislature enacted s. 215.5602, F.S., which established within the DOH the King
Program. The purpose of the King Program is to provide an annual and perpetual source of
funding to support research initiatives that address the health care problems of Floridians in the
areas of tobacco-related cancer, cardiovascular disease, stroke, and pulmonary disease. The
Legislature established the following long-term goals for the King Program:
Improve Floridians’ health by researching better prevention, diagnoses, treatments, and cures
for cancer, cardiovascular disease, stroke, and pulmonary disease;
Expand biomedical knowledge relating to the prevention, diagnosis, treatment, and cure of
diseases related to tobacco use, including cancer, cardiovascular disease, stroke, and
pulmonary disease;
Improve the quality of the state's academic health centers by bringing the advances of
biomedical research into the training of physicians and other health care providers;
Increase the state’s per capita funding for research by undertaking new initiatives in public
health and biomedical research that will attract additional outside the state funding.
6
Department of Health, Biomedical Research Advisory Council Report, William G. “Bill” Bankhead Jr., and David Coley
Cancer Research Program, James and Esther King Biomedical Research Program , and Live Like Bella Pediatric Cancer
Research Initiative, 2020-2021, p. 2., available at http://www.floridahealth.gov/provider-and-partner-
resources/research/research-programs1/2021BiomedicalResearchAdvisoryCouncilAnnualReport.pdf (last visited Jan. 25,
2022).
7
Id.
8
Supra note 6. BILL: CS/SB 1010 Page 4
Stimulate economic activity in areas related to biomedical research, such as the research and
production of pharmaceuticals, biotechnology, and medical devices.
9
Funds appropriated by the Legislature for the King Program must be used exclusively for the
award of grants and fellowships for research relating to the prevention, diagnosis, treatment, and
cure of diseases related to tobacco use, including cancer, cardiovascular disease, stroke, and
pulmonary disease; and for the King Program’s administrative expenses. Priority must be
granted to research designed to prevent or cure disease.
Section 215.5602, F.S., also created within the DOH the Biomedical Research Advisory Council
(council). The council advises the Surgeon General as to the direction and scope of the
biomedical research programs. All grants and fellowships are awarded by the Surgeon General,
in consultation with the council, on the basis of scientific merit, as determined by the
competitively open, peer-reviewed process to ensure objectivity, consistency, and high quality.
The following types of applications may be considered for funding:
Investigator-initiated research grants;
Institutional research grants; and
Predoctoral and postdoctoral research fellowships.
10
The council awards grants for cancer research through the William G. “Bill” Bankhead, Jr., and
David Coley Cancer Research Program created in s. 381.922, F.S.
11
The William G “Bill” Bankhead Jr., and David Coley Cancer Research Program
The Legislature established the Bankhead-Coley Program in 2004 with the enactment of
s. 381.922, F.S. The Legislature gave the Bankhead-Coley Program two goals to expand cancer
research capacity in the state: expand capacity, and improve research and treatment through
greater participation in clinical trials.
The Bankhead-Coley Program expands cancer research capacity by:
Identifying ways to attract new research talent and national grant-producing researchers to
cancer research facilities;
Implementing a peer-reviewed, competitive process to identify and fund the best proposals to
expand cancer research;
Funding proposals that demonstrate the greatest opportunity to attract federal research grants
and private financial support;
Encouraging the employment of bioinformatics in order to create a cancer informatics
infrastructure that enhances information and resource exchange and integration through
researchers working in diverse disciplines, to facilitate the full spectrum of cancer
investigations;
Facilitating the technical coordination, business development, and support of intellectual
property as it relates to the advancement of cancer research; and
9
Section 215.5602, F.S.
10
Id.
11
Section 215.5602(11), F.S. BILL: CS/SB 1010 Page 5
Aiding in other multidisciplinary research-support activities to advance cancer research.
12
The Bankhead-Coley Program’s second goal is to improve research and treatment through
greater participation in clinical trials networks by:
Identifying ways to increase adult enrollment in cancer clinical trials;
Supporting public and private professional education programs designed to increase
awareness and knowledge about cancer clinical trials;
Providing tools to cancer patients and community-based oncologists to aid in the
identification of available cancer clinical trials available;
Creating opportunities for the state's academic cancer centers to collaborate with community-
based oncologists in cancer clinical trials networks; and
Reducing the impact of cancer on disparate groups by:
o Identifying those cancers that disproportionately impact certain demographic groups; and
o Building collaborations designed to reduce health disparities as they relate to cancer.
13
Live Like Bella Pediatric Cancer Research Initiative
Within the Bankhead -Coley Program, the Legislature also established the Bella Initiative. The
purpose of the Bella Initiative is to advance progress toward curing pediatric cancer by awarding
grants through a peer-reviewed, competitive process.
The DOH also administers funding opportunities for the Bella Initiative which is subject to
annual appropriation of funds by the Legislature.
14
The Bella Initiative pursues the following
goals:
Significantly expand pediatric cancer research capacity in Florida;
Improve both research and treatment through greater pediatric enrollment in clinical trials
networks; and
Reduce the impact of pediatric cancer on disparate groups.
15
Ed and Ethel Moore Alzheimer's Disease Research Program
In 2014, the Legislature created the Ed and Ethel Moore Alzheimer's Disease Research Program
(Moore Alzheimer’s Program) within the DOH to fund research leading to prevention of or a
cure for Alzheimer’s disease. The Legislature established the program’s long-term goals to
improve Floridians health, expand the foundation of knowledge relating to the prevention,
diagnosis, treatment, and cure of Alzheimer’s disease, and to stimulate economic activity in the
state in areas related to Alzheimer’s disease research.
16
12
Section 381.922, F.S.
13
Department of Health, Provider and Partner Resources Research, Research Programs, Research on Cancer and Tobacco-
related Diseases, James and Esther King Biomedical Research Program, available at http://www.floridahealth.gov/provider-
and-partner-resources/research/research-programs1/research-cancer-tobacco.html (last visited Jan. 25, 2022).
14
Section 381.922(2)(c), F.S.
15
Florida Department of Health, Live Like Bella Pediatric Cancer Research Initiative, Funding Opportunity Announcement,
FY 2017 - 2018, Overview, Introduction, available at https://www.floridahealth.gov/provider-and-partner-
resources/research/FINAL%20Live%20Like%20Bella%20Pediatric%20Cancer%20Research%20Initiative%20FOA.pdf (last
visited Jan. 25, 2022).
16
Section 381.82, F.S. BILL: CS/SB 1010 Page 6
The Alzheimer’s Disease Research Grant Advisory Board advises the Surgeon General as to the
direction and scope of the Alzheimer’s disease research program. Grants and fellowships must be
awarded by the Surgeon General, after consultation with the board, on the basis of scientific
merit.
17
Uterine Fibroids
Uterine fibroid lesions were initially known as the “uterine stone.” The term “fibroid” was first
introduced in the 1860s. Uterine fibroids are the most common pelvic tumors among women of
reproductive age, affecting more than 70 percent of women worldwide, particularly women of
color.
Although benign, uterine fibroids are associated with significant morbidity; they are the primary
indication for hysterectomy and a major source of gynecologic and reproductive dysfunction,
ranging from menorrhagia
18
and pelvic pain to infertility, recurrent miscarriage, and preterm
labor. The annual U.S. health care costs associated with uterine fibroids have been estimated at
approximately $34 billion. Uterine fibroids thus represent significant societal health and financial
burdens on the U.S. health care system and economy.
19
Diagnosis and Treatment
The growth of fibroids that originate from the uterine’s smooth muscle tissue (myometrium) is
dependent on estrogen and progesterone. Fibroids are rare before puberty, increase in prevalence
during the reproductive years, and decrease in size after menopause. Uterine fibroids are
classified based on location: subserosal (projecting outside the uterus), intramural (within the
myometrium), and submucosal (projecting into the uterine cavity).
The symptoms and treatment options for fibroids are affected by size, number, and location. The
most common symptom is abnormal uterine bleeding, usually manifesting as excessive
menstrual bleeding. Other symptoms include pelvic pressure, bowel dysfunction, urinary
frequency and urgency, urinary retention, low back pain, constipation, and painful intercourse.
Treatment of uterine fibroids should be tailored to the size and location of the tumors; the
patient’s age, symptoms, desire to maintain fertility, and access to treatment; and the physician’s
experience. The ideal treatment satisfies four goals: relief of signs and symptoms, sustained
reduction of the size of fibroids, maintenance of fertility (if desired), and avoidance of harm.
20
17
Id.
18
Menorrhagia is heavy or prolonged menstrual bleeding. John Hopkins Medicine, Health, Menorrhagia, What is
menorrhagia? available at https://www.hopkinsmedicine.org/health/conditions-and-diseases/menorrhagia (last visited Jan.
27, 2022).
19
Yang Q, Ciebiera M, Bariani M, Ali M, Elkafas H, Boyer T, and Al-Hendy A, Endocrine Society Oxford, Endocrine
Reviews, 2022, Vol. XX, No. XX, 1–43 Comprehensive Review of Uterine Fibroids: Developmental Origin, Pathogenesis,
and Treatment, (Nov. 2021) available at https://academic.oup.com/edrv/advance-
article/doi/10.1210/endrev/bnab039/6422392 (last visited Jan. 27, 2022).
20
Maria Syl D. De La Cruz, MD, & Edward M. Buchanan, MD, Sidney Kimmel Medical College, Thomas Jefferson
University, Philadelphia, Pa., published by American Family Physician, Vol. 95, No.2, (Jan. 15, 2017) Uterine Fibroids:
Diagnosis and Treatment, available at https://www.aafp.org/afp/2017/0115/afp20170115p100.pdf (last visited Jan. 27, 2022). BILL: CS/SB 1010 Page 7
III. Effect of Proposed Changes:
CS/SB 1010 creates s. 381.9312, F.S., which requires the DOH to develop and maintain an
electronic database of information related to uterine fibroids. The purpose of the database is to
encourage research relating to the diagnosis and treatment of uterine fibroids and ensure that
women are provided with the relevant information and health care necessary to prevent and treat
uterine fibroids.
The bill defines “health care provider” to include physicians licensed under chs. 458 or 459, F.S.,
or an AAPRN registered under s. 464.0123, F.S.; and a “uterine fibroid” as a noncancerous
growth of the uterus that often appears during a woman’s childbearing years.
The database must include, but need not be limited to, all of the following information:
Incidence and prevalence of women diagnosed with uterine fibroids in Florida;
Demographic attributes of women diagnosed with uterine fibroids in Florida; and
Treatments and procedures for uterine fibroids used by health care providers in Florida.
A health care provider who diagnoses or treats a woman with uterine fibroids must submit
information relating to such diagnosis or treatment to the DOH in a form and manner prescribed
by DOH rule for inclusion in the database. Such information may be submitted along with any
reports or other information that the health care provider is required to submit to the DOH
pursuant to state law.
The database may not include any personal identifying information of women diagnosed with or
treated for uterine fibroids. Such information is confidential and may be used only by employees
or agents of the DOH for the purpose of conducting uterine fibroid research.
The DOH must develop and include information related to uterine fibroids in literature on
women's health care which is currently made available to the public, to increase public
awareness of uterine fibroids. The information must include, but need not be limited to:
The possible risk factors of developing uterine fibroids; and
The range of available treatment options that are considered alternatives to a hysterectomy.
The bill provides an effective date of July 1, 2022.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None. BILL: CS/SB 1010 Page 8
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 impact on private health care practitioners due to the potential need
for additional staff time, record keeping, and reporting of required information on
patients with uterine fibroids they diagnose and treat.
C. Government Sector Impact:
The DOH estimates a fiscal impact of $1,426,688, including $1,210,149 in nonrecurring
funds and $216,539 in recurring funding, to procure, develop, and implement the required
database, as well as training health care providers on the bill’s new reporting
requirement. This funding includes three data-entry staff and one epidemiologist in the
“other personal services” category.
21
VI. Technical Deficiencies:
None.
VII. Related Issues:
None.
VIII. Statutes Affected:
This bill creates section 381.9212 of the Florida Statutes.
IX. Additional Information:
A. Committee Substitute – Statement of Substantial Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
CS by Health Policy on February 2, 2022:
The CS:
21
E-mail from the Department of Health to the Senate Health Policy Committee (Jan. 24, 2022) (on file with Senate Health
Policy Committee). BILL: CS/SB 1010 Page 9
Revises the bill's definition of “health care provider” to include allopathic and
osteopathic physicians, as opposed to only allopathic physicians as in the underlying
bill;
Clarifies that AAPRNs referenced in the definition are autonomous AAPRNs;
Deletes the FMA’s participation in DOH’s development and dissemination of
information to health care providers and in the bill’s public awareness campaign; and
Revises the risk factors for which DOH must develop information related to fibroids
in women’s health care.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.