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 Fiscal Policy
BILL: CS/SB 612
INTRODUCER: Health Policy Committee and Senator Yarborough and others
SUBJECT: Blood Clot and Pulmonary Embolism Policy Workgroup
DATE: April 19, 2023 REVISED:
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Stovall Brown HP Fav/CS
2. McKnight Money AHS Favorable
3. Stovall Yeatman FP Favorable
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/SB 612 creates the “Emily Adkins Prevention Act” to establish a blood clot and pulmonary
embolism policy workgroup. The Secretary of Health Care Administration (Secretary), in
conjunction with the State Surgeon General, are required to establish the policy workgroup
composed of health care providers, patients who have experienced blood clots, family members
of patients who have died from blood clots, advocates, and other interested parties and
associations.
The workgroup is tasked with identifying specific background information pertaining to the
prevalence, data collection, impacts, standards of care, and emerging treatments of blood clots
and pulmonary embolisms. The workgroup is further tasked with developing a risk surveillance
system for various health care providers and facilities and policy recommendations to improve
patient awareness, including written materials and guidelines that affect the standard of care for
patients at risk of forming blood clots.
The Secretary is directed to submit a final report detailing findings and recommendations to the
Governor, the President of the Senate, and the Speaker of the House of Representatives by
January 4, 2025.
The bill has no fiscal impact on state revenues or state expenditures.
The bill takes effect on July 1, 2023.
BILL: CS/SB 612 Page 2
II. Present Situation:
A pulmonary embolism (PE) is a sudden blockage in a pulmonary artery resulting from a blood
clot that develops in a blood vessel (often in the leg) that travels through the circulatory system
to a lung, creating the blockage in blood flow.1
The heart, arteries, capillaries, and veins make up the body's circulatory system. Blood is
pumped with great force from the heart into the arteries. From there blood flows into the
capillaries (tiny blood vessels in the tissues). Blood returns to the heart through the veins. As it
moves through the veins back to the heart, blood flow slows. Sometimes this slower blood flow
may lead to clot formation.
Blood clotting is a normal process to prevent bleeding. The body makes blood clots and then
breaks them down. Under certain circumstances, the body may be unable to break down a clot.
When blood clots in a vein, it may be due to the slowed blood flow, an abnormality in clot
forming, or from an injury to the blood vessel wall.
Blood clots can form in arteries and veins. Clots formed in veins are called venous clots. Veins
of the legs can be superficial veins (close to the surface of the skin) or deep veins (located near
the bone and surrounded by muscle).
Venous clots most often happen in the deep veins of the legs. This is called deep vein thrombosis
(DVT). Once a clot has formed in the deep veins of the leg, there is a potential for part of the clot
to break off and travel through the blood to another area of the body, often the lung. DVT is the
most common cause of a pulmonary embolism.
Other less frequent sources of pulmonary embolism are a fat embolus (often linked to the
breaking of a large bone), amniotic fluid embolus, air bubbles, and a deep vein thrombosis in the
upper body. Clots may also form on the end of an indwelling intravenous (IV) catheter, break
off, and travel to the lungs.
Risk factors2
Although anyone can develop blood clots that result in a pulmonary embolism, certain factors
can increase the risk.
History of blood clots.
Some medical conditions and treatments create higher risk, such as:
o Heart disease. Heart and blood vessel disease, specifically heart failure, makes clot
formation more likely.
o Cancer. Certain cancers, especially brain, ovary, pancreas, colon, stomach, lung and
kidney cancers, and cancers that have spread, can increase the risk of blood clots.
Chemotherapy further increases the risk.
1
Johns Hopkins Medicine, Pulmonary Embolism, available at https://www.hopkinsmedicine.org/health/conditions-and-
diseases/pulmonary-embolism (last visited Mar. 22, 2023).
2
Mayo Clinic, Pulmonary embolism, available at https://www.mayoclinic.org/diseases-conditions/pulmonary-
embolism/symptoms-causes/syc-20354647 (last visited Mar. 22, 2023).
BILL: CS/SB 612 Page 3
o Surgery. Surgery is one of the leading causes of problem blood clots. For this reason,
medicine to prevent clots may be given before and after major surgery, such as joint
replacement.
o Disorders that affect clotting. Some inherited disorders affect blood, making it more
likely to clot. Other medical disorders such as kidney disease also can increase the risk of
blood clots.
o COVID-19. People who have severe symptoms of COVID-19 have an increased risk of
pulmonary embolism.
Blood clots are more likely to form during longer than usual periods of inactivity, such as:
o Bed rest. Being confined to bed for an extended period after surgery, a heart attack, leg
fracture, trauma, or any serious illness creates higher risk of blood clots.
o Long trips. Sitting in a cramped position during lengthy plane or car trips slows blood
flow in the legs, which increases the risk of blood clots.
Other risk factors
Smoking. For reasons that aren't well understood, tobacco use increases the risk of blood
clots in some people, especially those who have other risk factors.
Being overweight. Excess weight increases the risk of blood clots – particularly in people
with other risk factors.
Supplemental estrogen. The estrogen in birth control pills and in hormone replacement
therapy can increase clotting factors in the blood, especially in those who smoke or are
overweight.
Pregnancy. The weight of a baby pressing on veins in the pelvis can slow blood return from
the legs. Clots are more likely to form when blood slows or pools.
Symptoms
Pulmonary embolism symptoms can vary greatly, depending on how much of the lung is
involved, the size of the clots, and the existence of underlying lung or heart disease.
Common symptoms include:
Shortness of breath. This symptom usually appears suddenly. Trouble catching one’s breath
happens even when resting and gets worse with physical activity.
Chest pain. Afflicted persons might feel like they are having a heart attack. The pain is often
sharp and felt when taking deep breaths.
Fainting. An afflicted person may pass out if his or her heart rate or blood pressure drops
suddenly. This is called syncope.
Other symptoms that can occur with pulmonary embolism include:
A cough that may include bloody or blood-streaked mucus.
Rapid or irregular heartbeat.
Lightheadedness or dizziness.
Excessive sweating.
Fever.
Leg pain or swelling, or both, usually in the back of the lower leg.
Clammy or discolored skin, called cyanosis.
BILL: CS/SB 612 Page 4
Treatment for pulmonary embolism3
Treatment choices for pulmonary embolism (PE) include:
Anticoagulants. Also described as blood thinners, these medicines decrease the ability of the
blood to clot. This helps stop a clot from getting bigger and keep new clots from forming.
Fibrinolytic therapy. Also called clot busters, these medicines are given intravenously (IV or
into a vein) to break down the clot. These medicines are only used in life-threatening
situations.
Vena cava filter. A small metal device placed in the vena cava (the large blood vessel that
returns blood from the body to the heart) may be used to keep clots from traveling to the
lungs. These filters are generally used when a person cannot tolerate anticoagulation
treatment (for medical reasons), develops more clots even with anticoagulation treatment, or
has bleeding problems from anticoagulation medicines.
Pulmonary embolectomy. Rarely used, this is surgery is performed to remove a PE. It is
generally done only in severe cases when a PE is very large, the patient cannot get
anticoagulation and/or thrombolytic therapy due to other medical problems or he or she has
not responded well to those treatments, or the patient’s condition is unstable.
Percutaneous thrombectomy. A long, thin, hollow tube (catheter) can be threaded through the
blood vessel to the site of the embolism guided by X-ray. Once the catheter is in place, it is
used to break up the embolism, pull it out, or dissolve it using thrombolytic medicine.
An important aspect of treating a PE is treatment to prevent formation of additional embolisms.
Task Force
A “workgroup” is not defined in the Florida Statutes. However, s. 20.03, F.S., includes
definitions related to the required organizational structure of task forces. In part, it defines a
“task force” as an advisory body created without specific statutory enactment for a time not to
exceed one year or created by specific statutory enactment for a time not to exceed three years
and appointed to study a specific problem and recommend a solution or policy alternative with
respect to that problem. Its existence terminates upon the completion of its assignment.4
III. Effect of Proposed Changes:
Section 1 creates a non-statutory section of law citing the bill as the “Emily Adkins Prevention
Act.”
Section 2 creates s. 408.0621, F.S., to establish the blood clot and pulmonary embolism policy
workgroup. The Secretary of Health Care Administration (Secretary), in conjunction with the
State Surgeon General, are required to establish the workgroup tasked with the following:
Identifying the aggregate number of people who experience blood clots and pulmonary
embolisms each year in this state.
3
Johns Hopkins Medicine, Pulmonary Embolism, available at https://www.hopkinsmedicine.org/health/conditions-and-
diseases/pulmonary-embolism (last visited Mar. 22, 2023).
4
Section 20.30(8). F.S.
BILL: CS/SB 612 Page 5
Identifying how data is collected regarding blood clots, pulmonary embolisms, and adverse
health outcomes associated with these conditions.
Identifying how blood clots and pulmonary embolisms impact the lives of people in this
state.
Identifying the standards of care for blood clot surveillance, detection, and treatment.
Identifying emerging treatments, therapies, and research relating to blood clots.
Developing a risk surveillance system to help health care providers identify patients who
may be at higher risk of forming blood clots and pulmonary embolisms.
Developing policy recommendations to help improve patient awareness of blood clot risks.
Developing policy recommendations to help improve surveillance and detection of patients
who may be at a higher risk of forming blood clots in licensed health care facilities,
including, hospitals, nursing homes, assisted living facilities, residential treatment facilities,
and ambulatory surgical centers.
Developing policy recommendations relating to guidelines used that affect the standard of
care for patients at risk of forming blood clots.
Developing policy recommendations relating to providing patients and their families with
written notice of increased risks of forming blood clots.
The bill requires the workgroup to be composed of health care providers, patients who have
experienced blood clots, family members of patients who have died from blood clots, advocates,
and other interested parties and associations.
The bill requires the President of the Senate and the Speaker of the House of Representative to
each appoint two members to the workgroup and the State Surgeon General to appoint the chair
of the workgroup. The bill authorizes the chair to create subcommittees to help with research,
scheduling speakers on important subjects, and drafting a workgroup report and policy
recommendations.
The bill authorizes meetings of the workgroup to be held through teleconference or other
electronic means and prohibits workgroup members from being compensated.
The Secretary is required to submit a final report detailing the findings and recommendations to
the Governor, the President of the Senate, and the Speaker of the House of Representatives by
January 4, 2025.
Section 3 provides an effective date of July 1, 2023.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
BILL: CS/SB 612 Page 6
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:
The bill has no fiscal impact on state revenues or state expenditures.5
VI. Technical Deficiencies:
None.
VII. Related Issues:
None.
VIII. Statutes Affected:
This bill creates section 408.0621 of the Florida Statutes.
This bill creates one non-statutory section of the Laws of Florida.
IX. Additional Information:
A. Committee Substitute – Statement of Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
CS by Health Policy on March 27, 2023:
5
Agency for Health Care Administration, HB 483 Bill Analysis (January 27, 2023) (on file with Senate Appropriations
Committee on Health and Human Services).
BILL: CS/SB 612 Page 7
The CS changes the citation for the Act to the “Emily Adkins Prevention Act” and
establishes the workgroup in a newly created statute. The number of appointed members
on the workgroup is reduced from 17 to five. The amendment is silent on reimbursement
for per diem or travel expenses. The CS streamlines the responsibilities of the workgroup
and focuses the policy recommendations on the risks of forming blood clots and early
detection and prevention. The CS requires an annual report that includes detailed findings
and recommendations rather than an update on the workgroup’s activities, findings, and
recommendations. Submission of the final report is moved up from January 31, 2025, to
January 4, 2025. The CS eliminates the sunset date for the workgroup included in the
underlying bill.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.