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: SB 1318
INTRODUCER: Senator Harrell
SUBJECT: Organ Donation and Transplantation
DATE: March 29, 2021 REVISED:
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Looke Brown HP Favorable
2. AHS
3. AP
I. Summary:
SB 1318 amends various sections of the Florida statutes related to organ donation and
transplantation. The bill:
Requires locations where hunting, fishing, or trapping licenses are sold to make educational
materials regarding organ donation available to the public and includes such recreational
licenses and permits in the current program designed to encourage persons to sign up as an
organ donor when being issued a driver license or identification card. Additionally, the bill
requires that each person who applies for such license or permit over the Internet must be
provided with a link to the statewide donor registry.
Requires the Agency for Health Care Administration (AHCA) to include minimum volume
standards for organ transplantation and neonatal intensive care services in the AHCA’s
licensure rules for tertiary services.1
Allows the AHCA to pay, through Medicaid, for organ transplantation services, including
pre-transplant, transplant, and post-discharge services, and treatment of complications after
transplantation, for transplants deemed necessary and appropriate within the guidelines set by
the Organ Transplant Advisory Council.
Prohibits a preexisting condition provision in a health insurance policy from excluding
coverage solely on the basis that the insured is a living organ donor.
Expands the donor registry education program to include federal law, to require the
contractor providing the education program to work with the AHCA and the State Board of
Education to develop an instructional curriculum for students in grades 9 through 12 relating
to organ donor registration, and to require public schools to teach organ donor registration to
students in grades 9 through 12.
Prohibits an organ transplantation facility from charging a donor or his or her family member
any fee for services relating to the procurement or donation of his or her organs.
1
Including organ transplantation, neonatal intensive care services, inpatient psychiatric services, inpatient substance abuse services, or
comprehensive medical rehabilitation.
BILL: SB 1318 Page 2
Requires any individual who requests the consent for an anatomical gift from the health care
surrogate or family of a person who is, or will be, recently deceased in a hospital to clearly
explain to patients and living organ donors the protocols of the hospital and the federal and
state laws regarding organ donation.
Requires the Organ and Tissue Procurement and Transplantation Advisory Board (OTPTAB)
to work with relevant public and private entities to develop the necessary professional
qualifications, including continuing education, for licensed health care practitioners and other
persons engaged in the various facets of organ and tissue procurement. The bill also requires
the OTPTAB to submit specified recommendations to the AHCA by September 1, 2022.
The bill provides an effective date of July 1, 2021.
II. Present Situation:
Organ Donation
Organ and tissue donation is the process of surgically removing an organ or tissue from one
person (the donor) and transplanting it into another person (the recipient). Transplantation in
such cases is necessary because the recipient’s organ has failed or has been damaged by disease
or injury. Transplantable organs include the kidneys, liver, heart, lungs, pancreas and intestine. 2
Transplantable tissue include skin used as a temporary dressing for burns, serious abrasions and
other exposed areas; heart valves used to replace defective valves; tendons used to repair torn
ligaments on knees or other joints; veins used in cardiac bypass surgery; corneas used to restore
sight; and bone used in orthopedic surgery to facilitate healing of fractures or prevent
amputation.3
A single person can save up to eight lives through organ donation, and dozens more lives may be
improved through tissue donation.4 While most organ and tissue donations occur after the donor
has died, some organs and tissues can be donated while the donor is alive, such as a kidney or
part of a liver or lung.5 There are approximately as many living donors every year as there are
deceased donors.6
Organ Donation, Procurement, and Transplant Process
Established by the National Organ Transplant Act (NOTA) of 1984, the Organ Procurement and
Transplantation Network (OPTN) is a public-private partnership that links all professionals
involved in the nation’s donation and transplant system.7 The United Network for Organ Sharing
(UNOS), a private, non-profit organization based in Richmond, Virginia, serves as the OPTN
under contract with the U.S. Department of Health and Human Services.8 UNOS coordinates
2 Donate Life Florida, Frequently Asked Questions, available at https://www.donatelifeflorida.org/categories/donation/ (last visited Mar.
23, 2021).
3 Id.
4 Id.
5 U.S. Government Information on Organ Donation and Transplantation, U.S. Department of Health & Human Services, How Organ
Donation Works, available at https://organdonor.gov/about/process.html (last visited Mar. 3, 2021).
6 Id.
7 U.S. Department of Health and Human Services, Organ Procurement and Transplantation Network – About the OPTN, available at
https://optn.transplant.hrsa.gov/governance/about-the-optn/ (last visited Mar. 23, 2021).
8 Id.
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how donor organs are matched and allocated to patients on the waiting list.9 Non-profit, federally
designated organ procurement organizations (OPOs) work closely with UNOS, hospitals, and
transplant centers to facilitate the organ donation and transplantation process,10 including
conducting a thorough medical and social history of the potential donor to help determine the
suitability of his or her organs for transplantation.11
Regulation of Organ Donation, Procurement, and Transplantation in Florida
The AHCA oversees the various organizations and facilities involved in the organ procurement
and transplant process in this state. The AHCA licenses transplant facilities, contracts with an
organization to educate the public on organ donation, sets requirements for training individuals
who engage with families whose deceased relatives may be a good candidate for organ donation,
and supports the Organ Transplant Advisory Council and the Organ and Tissue Procurement and
Transplantation Advisory Board.
Organ Donor Registry
In 2008,12 Florida’s Legislature found that a shortage of organ and tissue donors existed in
Florida. Findings included a need for:
A statewide donor registry with online donor registration capability; and
Enhanced donor education, to increase the number of organ and tissue donors.
The online registry would afford more persons who are awaiting organ or tissue transplants the
opportunity for a full and productive life.13 As directed by the Legislature, the AHCA and the
Department of Highway Safety and Motor Vehicles (DHSMV) jointly contracted for the
operation of Florida’s interactive web-based donor registry that allows for online donor
registration and the recording of organ and tissue donation records submitted through the driver
license identification program or through other sources. The AHCA and the DHSMV selected
Donate Life Florida, which is a coalition of Florida’s organ, tissue, and eye donor programs, to
run the donor registry and maintain donor records.
Floridians aged 18 or older can join the donor registry either online, at the DHSMV (or their
local driver license office), or by contacting Donate Life Florida for a paper application.14
Children aged 13 to 17 may join the registry, but the final decision on any organ donation of a
minor rests with the parent or guardian. The registry collects personal information from each
donor including, but not limited to, his or her name, address, date and place of birth, race,
ethnicity, and driver’s license number.
As of March 23, 2021, there were 11,496,288 people registered in the donor registry.15
9 U.S. Government Information on Organ Donation and Transplantation, U.S. Department of Health & Human Services, The Organ
Transplant Process, available at https://organdonor.gov/about/process/transplant-process.html (last visited Mar. 23, 2021).
10 Donate Life Florida, Organ Procurement Organizations and Transplant Centers, available at https://www.donatelifeflorida.org/local-
resources/transplant-centers/ (last visited Mar. 23, 2021).
11 Organ Procurement and Transplantation Network, U.S. Department of Health & Human Services, The Basic Path of Donation, available
at https://optn.transplant.hrsa.gov/learn/about-donation/the-basic-path-of-donation/ (last visited Mar. 23, 2021).
12 Ch. 2008-223, Laws of Fla.
13 Section 765.5155(1), F.S.
14 Donate Life Florida, Welcome to the Joshua Abbott Organ and Tissue Donor Registry, available at http://www.donatelifeflorida.org/
(last visited Mar. 23, 2021)
15 Id.
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A person may make an anatomical gift of all or part of his or her body by:16
Signing an organ and tissue donor card;
Registering online with the donor registry;
Signifying an intent to donate on his or her driver license or identification card issued by the
DHSMV;17
Expressing a wish to donate in a living will or other advance directive;
Executing a will that includes a provision indicating that the testator wishes to make an
anatomical gift;18 or
Expressing a wish to donate in a document other than a will.19
Donor Education
When a patient dies in a hospital and is not a registered organ donor, but is determined to be a
good candidate by the hospital’s medical staff and the OPO, a representative of the OPO or a
member of the hospital’s staff may approach the patient’s family about organ donation.20 The
AHCA has developed rules for training and guidelines for the person making the request for
organ donation.21 The requestor is trained in explaining the process of organ donation to the
patient’s family, including their right to allow or refuse donation and for what purpose the organs
would be donated (transplantation, research, or education).22 The requestor is also specifically
trained in the different types of approaches to deal with a family’s grief and offering them the
opportunity for organ donation.23 The current rules require the requestor to explain the
requirements that need to be met under Florida law in order for a donation to be allowed but is
silent regarding an explanation of federal regulations relating to organ donation.
Organ Donation Fees
Generally, an organ donor and their family are not charged by a transplant facility for the
medical care required to donate an organ.24 Families pay for medical care and funeral costs, but
costs related to living or deceased donation are paid by the recipient, usually through insurance,
including Medicare, or Medicaid.25 Typically, any cost that falls outside of the transplant center’s
donor evaluation or actual surgery, such as travel, lodging, lost wages, and other non-medical
expenses, is borne by the living donor or recipient.26
16 Section 765.514(1), F.S.
17 Revocation, suspension, expiration, or cancellation of the driver license or identification card does not invalidate the gift.
18 The gift becomes effective upon the death of the testator without waiting for probate. If the will is not probated or if it is declared invalid
for testamentary purposes, the gift is nevertheless valid to the extent that it has been acted upon in good faith.
19 The document must be signed by the donor in the presence of two witnesses who shall sign the document in the donor’s presence. If the
donor cannot sign, the document may be signed for him or her at the donor’s direction and in his or her presence and the presence of two
witnesses who must sign the document in the donor’s presence. Delivery of the document of gift during the donor’s lifetime is not
necessary to make the gift valid.
20 Health Resources and Services Administration, The Deceased Donation Process, available at
https://www.organdonor.gov/about/process/deceased-donation.html#authorize (last visited March 3, 2021). See also s. 765.522, F.S.
21 Fla. Admin. Code R. 59A-3.274 (2021).
22 Id.
23 Id.
24 Health Resources Services Administration, Organ Donation Frequently Asked Questions, available at
https://www.organdonor.gov/about/facts-terms/donation-faqs.html (last visited Mar. 23, 2021).
25 Id. See also UNOS, Living Donation Costs, available at https://transplantliving.org/financing-a-transplant/living-donation-costs/ (last
visited Mar. 23, 2021).
26 UNOS, Living Donation Costs, available at https://transplantliving.org/financing-a-transplant/living-donation-costs/ (last visited Mar.
23, 2021).
BILL: SB 1318 Page 5
Organ and Tissue Procurement and Transplantation Advisory Board
Created by the Legislature in 1991, the Organ and Tissue Procurement and Transplantation
Advisory Board (board) is housed at the AHCA. Current law requires the board to assist the
AHCA in the development of professional qualifications of people involved in the organ
donation and transplant process. The board is also tasked with helping AHCA monitor expenses
associated with organ and tissue procurement, processing, and distribution for transplantation.
Current law requires the board to provide assistance to the Florida Medical Examiners
Commission in the development of appropriate procedures and protocols to ensure the continued
improvement in the approval and release of potential donors by the district medical examiners
and associate medical examiners.27
Additionally, the board works with the AHCA on necessary recommendations for procedures
and protocols to assure that all Floridians have reasonable access to available organ and tissue
transplants according to the severity of his or her medical condition and need. In collaboration
with the AHCA, the board also develops recommendations for any changes to state laws or
administrative rules to ensure that the statewide organ and tissue procurement and transplantation
system is able to function smoothly, effectively, and efficiently, in accordance with federal
laws.28
The board consists of 14 members who are appointed by the Secretary of the AHCA, including:29
Two with expertise in vascular organ transplant surgery;
Two with expertise in vascular organ procurement, preservation, and distribution;
Two with expertise in musculoskeletal tissue transplant surgery;
Two with expertise in musculoskeletal tissue procurement, processing, and distribution;
One with expertise in eye and cornea transplant surgery;
One with expertise in eye and cornea procurement, processing, and distribution;
One with expertise in bone marrow procurement, processing, and transplantation;
A representative from the Florida Pediatric Society;
A representative from the Florida Society of Pathologists; and
A representative from the Florida Medical Examiners Commission.
The board has not met since 2013.30
Organ Transplantation Regulation
Federal law requires transplant hospitals to be a member of the OPTN and abide by OPTN
bylaws in order to provide transplant services.31 The federal certification requirements include
27 Section 765.543, F.S.
28 Id.
29 Section 765.543, F.S. See also Agency for Health Care Administration, Organ and Tissue Procurement and Transplantation Advisory
Board, available at https://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Lab_HomeServ/OrganTissueBoard.shtml (last visited
Mar. 23, 2021).
30 Agency for Health Care Administration, Organ and Tissue Procurement and Transplantation Advisory Board, available at
https://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Lab_HomeServ/OrganTissueBoard.shtml (last visited Mar. 23, 2021).
31 42 C.F.R. §482.72.<