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 Subcommittee on Health and Human Services
BILL: CS/SB 1010
INTRODUCER: Health Policy Committee and Senator Gibson
SUBJECT: Uterine Fibroid Research and Education
DATE: February 21, 2022
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Rossitto-Van
Winkle
Brown
HP
Fav/CS
2. Howard Money AHS Pre-meeting
3. AP
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/SB 1010 requires the Department of Health (department) to develop and maintain an
electronic database of information related to uterine fibroids. The bill requires specified health
care providers to submit to the department 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 chapters 458 or 459, Florida Statutes, and autonomous advanced
practice registered nurses (AAPRNs) licensed under section 464.0123, Florida Statutes.
The bill prohibits the database from including personal identifying information. The information
collected is confidential and may be used only by the department employees or agents for the
purpose of conducting research on uterine fibroids. The bill requires the department 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 department estimates a fiscal impact of $1.4 million to procure, develop, and implement the
required database, as well as training health care providers on the bill’s new reporting
requirement. See section V of this analysis.
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 department to protect and promote the health of all residents and
visitors in the state.
1
The department 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 department.
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
department, 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 department 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
department’s internal research capacity: the Research Excellence Initiative and Florida Health
Grand Rounds.
The Research Excellence Initiative is a year-long education program for the department
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 department. The topics
have a broad focus, touching on emerging, innovative, and cross-cutting areas of public health.
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). BILL: CS/SB 1010 Page 3
Florida Health Grand Rounds provides an opportunity for Florida researchers to highlight and
share their work with the department staff.
5
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 2020-2021, 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
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
9
and pelvic pain to infertility, recurrent miscarriage, and preterm
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).
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.
9
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). BILL: CS/SB 1010 Page 4
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.
10
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.
11
III. Effect of Proposed Changes:
The bill creates s. 381.9312, F.S., which requires the department 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.
10
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).
11
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 5
A health care provider who diagnoses or treats a woman with uterine fibroids must submit
information relating to such diagnosis or treatment to the department in a form and manner
prescribed by the department 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 department 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 department for the purpose of conducting uterine fibroid research.
The department 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.
D. State Tax or Fee Increases:
None.
E. Other Constitutional Issues:
None.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None. BILL: CS/SB 1010 Page 6
B. Private Sector Impact:
CS/SB 1010 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 Department of Health (department) 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.
12
VI. Technical Deficiencies:
None.
VII. Related Issues:
None.
VIII. Statutes Affected:
This bill creates section 381.9312 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:
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 the department’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 the department must develop information related to
fibroids in women’s health care.
B. Amendments:
None.
12
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 7
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.