This document does not reflect the intent or official position of the bill sponsor or House of Representatives.
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DATE: 3/25/2022
HOUSE OF REPRESENTATIVES STAFF FINAL BILL ANALYSIS
BILL #: CS/CS/CS/HB 543 Uterine Fibroid Research and Education
SPONSOR(S): Health & Human Services Committee and Appropriations Committee and Professions &
Public Health Subcommittee, Omphroy and others
TIED BILLS: IDEN./SIM. BILLS: CS/CS/SB 1010
FINAL HOUSE FLOOR ACTION: 113 Y’s
0 N’s GOVERNOR’S ACTION: Pending
SUMMARY ANALYSIS
CS/CS/CS/HB 543 passed the House on March 4, 2022, and subsequently passed the Senate on March 4,
2022.
Uterine fibroids are tumors that grow in a woman's uterus and are the most common benign tumors affecting
women. They are rare before puberty, increase in prevalence during the reproductive years, and decrease in
size after menopause. Treatment of fibroids depends on a woman’s age, general health, symptoms, type of
fibroids, whether she is pregnant, and her desire to have children in the future. Treatment ranges from
minimally invasive hormonal and medical treatments to major surgical interventions, such as hysterectomy.
CS/CS/CS/HB 543 requires health care practitioners who diagnose and treat women with fibroids to submit
information relating to such diagnosis or treatment to DOH. It requires DOH to develop and maintain an
electronic database of information related to uterine fibroids that includes, at a minimum, the following
information:
Incidence and prevalence of women diagnosed with fibroids in Florida;
Demographic attributes of women diagnosed with fibroids in Florida; and
Treatments and procedures for fibroids used by physicians and physician assistants licensed under
chapters 458 and 459, F.S., and APRNs licensed under ch. 464, F.S.
The bill prohibits DOH from including any personal identifying information of women with fibroids in its
database.
The bill also requires DOH to develop and include specified information about fibroids in certain women's
health care educational materials, including alternative treatment options to hysterectomy.
The bill provides an appropriation of $681,048 in nonrecurring funds and $121,852 in recurring funds from the
General Revenue Fund to DOH to implement the provisions of the bill.
Subject to the Governor’s veto powers, the effective date of this bill is July 1, 2022.
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I. SUBSTANTIVE INFORMATION
A. EFFECT OF CHANGES:
Present Situation
Uterine Fibroids
Uterine fibroids, which are tumors that grow in a woman's uterus,
1
place significant financial burdens on
the U.S. health care system and economy, with an estimated $34 billion in associated annual health
care costs.
2
These growths are typically benign (noncancerous) and are the most common benign
tumor affecting women.
3
They are rare before puberty, increase in prevalence during the reproductive
years, and decrease in size after menopause. As many as one in five women have fibroids during their
childbearing years and half of all women have them by age 50. Fibroids are also more common in
Black than White, Hispanic, or Asian women.
4
Although the exact cause of fibroids is unknown, they are thought to be caused by hormones in the
body and family history or genes.
5
In addition to age, race and ethnic origin, and family history, other
known risk factors include:
6
Obesity: Overweight or obese women are two or three times more likely to get fibroids than
normal weight women.
Eating Habits: Eating a lot of red meat and ham is linked with higher risk of fibroids.
Vitamin D deficiency: Vitamin D inhibits fibroid growth, but studies indicate only 10 percent of
Black women have adequate levels.
7
Diagnosis of Fibroids
Fibroids vary in size and weight
8
and can grow in different parts of the uterus.
9
Although it is possible
for just one fibroid to develop, most often there are multiple. Fibroids are not always easy to diagnose,
as some women have no symptoms. However, common symptoms are bleeding between periods,
heavy bleeding during periods, periods that last longer than normal, urinary frequency and urgency,
pelvic cramping or pain with periods, feeling fullness or pressure in the lower belly, and painful
intercourse.
10
Fibroids can also be diagnosed through a pelvic exam, which may show a change in the shape of a
woman’s uterus, or through the following tests:
11
Ultrasound, which uses sound waves to create a picture of the uterus.
1
The uterus is a hollow muscular organ that nourishes the developing baby during pregnancy. University of Florida Health (UFHealth),
Hysterectomy, https://ufhealth.org/hysterectomy (last visited Mar. 15, 2022).
2
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 Mar. 15, 2022).
3
National Center for Biotechnology Information (NCBI), Uterine Leiomymomata, https://www.ncbi.nlm.nih.gov/books/NBK546680/ (last
visited Mar. 15, 2022).
4
UFHealth, Uterine Fibroids, https://ufhealth.org/uterine-fibroids (last visited Mar. 15, 2022).
5
Id.
6
Florida Department of Health (DOH) Hernando County, Uterine Fibroids in Florida, 2021 Narrative Summary of the Data,
https://hernando.floridahealth.gov/newsroom/2021/07/UterineFibroids2021Report.html (last visited Mar. 15, 2022).
7
Id. Sunlight in moderation, supplements, and certain food sources can help improve Vitamin D levels.
8
Supra note 4. Some fibroids are microscopic, while others fill the entire uterus and weigh several pounds.
9
Supra note 4. Fibroids can grow in the muscle wall of the uterus (myometrial); just under the surface of the uterine lining
(submucosal); just under the outside lining of the uterus (subserosal); or on a long stalk on the outside the uterus or inside the uterus
(pedunculated).
10
Supra note 4.
11
Id.
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MRI, which uses powerful magnets and radio waves to create a picture.
Saline infusion sonogram, where saline is injected into the uterus to make it easier to see the
uterus using ultrasound.
Hysteroscopy, which uses a long, thin tube inserted through the vagina and into the uterus to
examine the inside of the uterus.
Endometrial biopsy, which removes a small piece of the lining of the uterus to check for cancer
if a woman has unusual bleeding.
Treatment of Fibroids
Treatment of fibroids depends on a woman’s age, general health, symptoms, type of fibroids, whether
she is pregnant, and her desire to have children in the future. Treatment ranges from minimally invasive
hormonal and medical treatments to major surgical interventions, such as hysterectomy.
Non-Surgical Treatment
There are various treatments for the symptoms of fibroids, such as intrauterine devices (IUDs) that
release hormones to help reduce heavy bleeding and pain and tranexamic acid to reduce the amount of
blood flow.
12
There are also medical or hormonal therapies to shrink fibroids,
13
including a type of IUD
that releases a low dose of the hormone progestin into the uterus each day.
14
Medical procedures used
to directly treat fibroids include:
15
Endometrial ablation, a procedure used to treat heavy bleeding associated with fibroids; and
Uterine artery embolization, a procedure that stops the blood supply to the fibroid, causing it to
shrink and die.
Surgical Treatments
Surgical procedures used to treat fibroids include:
16
Mysteroscopy, a procedure that removes fibroids growing inside the uterus;
Myomectomy, a procedure that removes fibroids from the uterus, but does not prevent new
fibroids from growing; and
Hysterectomy.
Hysterectomy is a major surgery to remove all or part of a woman’s uterus. The fallopian tubes and
ovaries may also be removed during the surgery.
17
Hysterectomy is the second most frequently
performed surgical procedure, after cesarean section, for women of reproductive age in the United
States. Approximately 600,000 hysterectomies are performed annually in the United States, and
approximately 20 million U.S. women have had a hysterectomy.
18
12
Other examples include iron supplements to prevent or treat anemia due to heavy periods; and pain relievers, such as ibuprofen or
naproxen, for cramps or pain.
13
Other examples include birth control pills to help control heavy periods and hormone shots to help shrink fibroids by stopping
ovulation.
14
Supra note 4.
15
Id.
16
Id.
17
UFHealth, Hysterectomy, https://ufhealth.org/hysterectomy (last visited Mar. 15, 2022).
18
Centers for Disease Control, Hysterectomy Surveillance --- United States, 1994—1999,
https://www.cdc.gov/mmwr/preview/mmwrhtml/ss5105a1.htm#:~:text=Problem%2FCondition%3A%20Hysterectomy%20is%20the,wom
en%20have%20had%20a%20hysterectomy . (last visited Mar. 15, 2022).
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In addition to the general risks of surgery,
19
hysterectomy specific risks include:
20
Injury to the bladder or ureters;
Pain during sexual intercourse;
Early menopause if the ovaries are removed;
Decreased interest in sex; and
Increased risk of heart disease if the ovaries are removed before menopause.
Florida Department of Health
Licensure of Health Care Providers
Chapter 458, F.S., governs licensure and regulation of allopathic physicians (medical doctors) and
physician assistants by the Florida Board of Medicine, in conjunction with the Florida Department of
Health (DOH). Chapter 459, F.S., governs licensure and regulation of osteopathic physicians and
physician assistants by the Florida Board of Osteopathic Medicine, in conjunction with DOH. Chapter
464, F.S., governs licensure and regulation of advanced practice registered nurses (APRNs) by the
Board of Nursing, in conjunction with DOH. These chapters govern licensure qualifications, scope of
practice, disciplinary actions, and obligations for such providers.
Uterine Fibroid Data
Currently, DOH is not required to provide women information on fibroids and does not have a
centralized database to track information for women with fibroids.
Additionally, health care providers
who diagnose or treat woman with fibroids are not required to submit information relating to such
diagnoses or treatments to DOH.
However, DOH does have a data-sharing agreement with the Agency for Health Care Administration
(AHCA) related to hospitalizations for fibroids. If a woman has a hospitalization related to fibroids, this
information is captured via the hospital discharge record. Current law requires hospitals to submit
hospital discharge data to AHCA,
21
which the AHCA then transmits to DOH per the data-sharing
agreement.
In 2016-2019, there were 16,842 hospitalizations related to fibroids among Florida women ages 15-54
years.
22
Patient Information Privacy – Personally Identifiable Information
Personally identifiable information is a general term describing data that could be used to identify or
contact an individual, such as names, addresses, phone numbers, and social security numbers.
Various federal laws regulate the use of personally identifiable information related to discrete federal
purposes, such as bankruptcy proceedings, education, and regulation of financial institutions.
23
However, unlike individually identifiable health information regulated for the entire health care industry
19
Risks include blood clots, which may cause death if they travel to the lungs, allergic reactions to medicines, breathing problems,
bleeding, infection, and injury to nearby body areas.
20
Supra, note 17.
21
Health care facilities must submit patient admission and discharge data to AHCA. See s. 408.061, F.S., and R. 59E-7 F.A.C.
22
DOH, Agency Bill Analysis for HB 543, p. 2 (Mar. 15, 2022).
23
See, e.g., 11 U.S.C. 101; 20 U.S.C. 1232g; 31 U.S.C. 5318.
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under the federal Health Information Portability and accountability Act (HIPAA)
24
, personally identifiable
information is not regulated by any one entity or uniformly for any one industry.
25
The term is not defined, nor is the concept generally regulated, in Florida law.
Effect of the Bill
Uterine Fibroid Data
CS/CS/CS/HB 543 requires DOH to develop and maintain an electronic database of information related
to uterine fibroids that includes, but is not limited to, the following information:
Incidence and prevalence of women diagnosed with fibroids in Florida;
Demographic attributes of women diagnosed with fibroids in Florida; and
Treatments and procedures for fibroids used in the state.
The bill requires physicians and physician assistants licensed under chapters 458 and 459, F.S., and
APRNs licensed under ch. 464, F.S., to submit to DOH information relating to their diagnoses and
treatments of women with fibroids, for inclusion in the database. The bill authorizes the practitioners to
submit this information with other information the provider must submit to DOH,
26
likely increasing
efficiency.
The bill authorizes DOH to adopt a rule on the form and manner of the data submission.
The bill also requires DOH to develop educational information about fibroids, including alternative
treatment options to hysterectomy, and include it in women's health care educational materials
currently made available to the public. This increase in awareness may to lead more women accepting
alterative treatment options to hysterectomy, which may reduce the significant annual health care costs
currently associated with hysterectomies.
Patient Information Privacy
The bill prohibits DOH from including any personal identifying information of women diagnosed with or
treated for uterine fibroids in the uterine fibroid database. The bill does not define “personal identifying
information”, nor is the term defined in current law. DOH’s rulemaking authority on the form and manner
of data submission may be sufficient authority for DOH to define what personal identifying information
should be excluded to comply with this prohibition.
The bill provides an effective date of July 1, 2022.
II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT
A. FISCAL IMPACT ON STATE GOVERNMENT:
1. Revenues:
None.
2. Expenditures:
24
Pub. L. No. 104-191; 18, 26, 29, and 42 U.S.C. ss. 18, 26, 29. See also 45 CFR Parts 160, 162, 164.
25
Accountable, Protected Health Information vs Personal Identifiable Information, https://www.accountablehq.com/post/pii-vs-
phi#:~:text=Personally%20Identifiable%20Information%2C%20or%20PII%2C%20is%20a%20general%20 term%20that,one%20industry
%20like%20PHI%20is. (last visited Mar. 15, 2022).
26
Examples include information to be included in the Florida Cancer Data System, pursuant to s. 385.202, F.S., and reports on
diseases and conditions pertaining to Epidemiological Research under s. 381.0031, F.S.
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The bill provides an appropriation of $802,900, including $681,048 in nonrecurring funds and
$121,852 in recurring funds to procure, develop, and implement the required database, as well as
training health care providers on the bill’s new reporting requirement.
B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
1. Revenues:
None.
2. Expenditures:
None.
C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
Health care providers may experience an increase in workload and costs associated with record
keeping and the bill’s reporting requirement.
D. FISCAL COMMENTS:
None.