This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives.
STORAGE NAME: h0543d.HHS
DATE: 2/28/2022
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: CS/CS/CS/HB 543 Uterine Fibroid Research and Education
SPONSOR(S): Health & Human Services Committee, Appropriations Committee, Professions & Public Health
Subcommittee, Omphroy and others
TIED BILLS: IDEN./SIM. BILLS: CS/SB 1010
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Professions & Public Health Subcommittee 15 Y, 0 N, As CS Rahming McElroy
2) Appropriations Committee 20 Y, 0 N, As CS Aderibigbe Pridgeon
3) Health & Human Services Committee 16 Y, 0 N, As CS Rahming Calamas
SUMMARY ANALYSIS
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.
Under current law, the Florida Department of Health (DOH) is not required to provide women
information on fibroids. Additionally, providers who treat women with fibroids are not required to
submit information relating to such diagnoses and treatments to DOH, and DOH does not have a
centralized database to track this data.
CS/CS/CS/HB 543 requires physicians, physician assistants, and advanced practice registered
nurses 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.
The bill provides an effective date of July 1, 2022. STORAGE NAME: h0543d.HHS PAGE: 2
DATE: 2/28/2022
FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED 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
o Overweight or obese women are two or three times more likely to get fibroids
than normal weight women.
Eating Habits
o Eating a lot of red meat and ham is linked with higher risk of fibroids.
Vitamin D deficiency
o 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
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 Feb. 8, 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 Jan. 27, 2022).
3
National Center for Biotechnology Information (NCBI), Uterine Leiomymomata, https://www.ncbi.nlm.nih.gov/books/NBK546680/ (last
visited Feb. 7, 2022).
4
UFHealth, Uterine Fibroids, https://ufhealth.org/uterine-fibroids (last visited Feb. 7, 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 Feb. 7, 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. STORAGE NAME: h0543d.HHS PAGE: 3
DATE: 2/28/2022
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.
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
11
Id.
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 Feb. 8, 2022). STORAGE NAME: h0543d.HHS PAGE: 4
DATE: 2/28/2022
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
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 Reporting and Database
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.
Between 2016-2019, there were 16,842 hospitalizations related to fibroids among Florida
women ages 15-54 years.
22
Patient Information Privacy
Health Information Portability and Accountability Act (HIPAA)
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 Feb. 8, 2022).
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 (Jan. 27, 2022). STORAGE NAME: h0543d.HHS PAGE: 5
DATE: 2/28/2022
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) protects personal
health information. Privacy rules were initially issued in 2000 by the U.S. Department of Health
and Human Services and later modified in 2002.
23
These rules address the use and disclosure
of an individual’s personal health information as well as create standards for information
security. Only certain entities are subject to HIPAA’s provisions. These “covered entities”
include:
24
Health plans;
Health care providers;
Health care clearinghouses; and
Business associates of any of the above.
Covered entities are obligated to meet HIPAA’s requirements to ensure privacy and
confidentiality personal health information, regardless of the method in which the medical
service is delivered.
The DOH is a covered entity and the fact that a person is diagnosed or treated for fibroids is
PHI.
Personally Identifiable Information
Personally Identifiable Information (PII) is a general term that is used to describe any form of
sensitive data that could be used to identify or contact an individual. This term is not related to
HIPAA and is not regulated by any one entity or in any one industry like PHI is.
25
Effect of the Bill
Uterine Fibroid Reporting and Database
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 this information to be submitted with other information the provider must submit to
DOH,
26
likely increasing efficiencies in reporting required information.
23
U.S. Department of Health and Human Services (HHS), The HIPAA Privacy Rule, available at
http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/ (last visited on Feb. 25, 2022).
24
45 CFR § 160.103
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%20term%20that,one%20industry
%20like%20PHI%20is. (last visited Feb. 24, 2022). PII has historically been known to just include social security numbers, phone
numbers, mailing or email addresses. However, as technology and software have advanced, the breadth of PII has also expanded. PII
can also include login IDs, digital images, IP addresses, social media posts and other digital forms of data.
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. STORAGE NAME: h0543d.HHS PAGE: 6
DATE: 2/28/2022
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. 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.
As a covered entity, DOH is also prohibited under federal law from including this information in
the database.
The bill provides an effective date of July 1, 2022.
B. SECTION DIRECTORY:
Section 1: Creates s. 381.9312, F.S., relating to uterine fibroid research database;
education and public awareness.
Section 2: Provides an appropriation.
Section 3: Provides an effective date.
II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT
A. FISCAL IMPACT ON STATE GOVERNMENT:
1. Revenues:
None.
2. Expenditures:
The bill provides an appropriation of $802,900, including $681,048 in nonrecurring funds
and $121,852 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.
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. STORAGE NAME: h0543d.HHS PAGE: 7
DATE: 2/28/2022
III. COMMENTS
A. CONSTITUTIONAL ISSUES:
1. Applicability of Municipality/County Mandates Provision:
None. The bill does not appear to affect county or municipal governments.
2. Other:
None.
B. RULE-MAKING AUTHORITY:
The bill provides DOH sufficient rulemaking authority to implement the bill.
C. DRAFTING ISSUES OR OTHER COMMENTS:
None.
IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES
On February 22, 2022, the Appropriations Committee adopted an amendment and reported
the bill favorably as a committee substitute. The amendment:
Appropriates $681,048 in nonrecurring funds and $121,852 in recurring General
Revenue to DOH to procure, develop, and implement the required database, as well as
train health care providers on the bill’s new reporting requirement.
This analysis is drafted to the committee substitute as passed by the Appropriations
Committee.
On February 28, 2022, the Health & Human Services Committee adopted an amendment and
reported the bill favorably as a committee substitute. The amendment:
Adds physician assistants to the definition of health care provider.
Prohibits DOH from including any personal identifying information of women diagnosed
with or treated for uterine fibroids in the uterine fibroid database.
This analysis is drafted to the committee substitute as passed by the Health & Human Services
Committee.