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 516
INTRODUCER: Senator Rouson
SUBJECT: Procurement Activities of For-profit Eye Banks
DATE: December 1, 2021
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Looke Brown HP Pre-meeting
2. CJ
3. RC
I. Summary:
SB 516 amends ss. 765.542 and 873.01, F.S., to prohibit a for-profit eye bank from directly or
indirectly engaging in the procurement of any eye, cornea, eye tissue, or corneal tissue for use in
live-cell corneal transplantation.
The bill exempts hospitals, ambulatory surgical centers (ASC), and medical examiners from this
prohibition.
The bill provides an effective date of July 1, 2022.
II. Present Situation:
Regulations and Standards for Tissue Processing
Tissue processing in the United States is governed by mandatory requirements enforced by
federal and state regulatory authorities. The authorization of donated tissues is governed by the
Uniform Anatomical Gift Act. Tissue banks in the United States are governed by the National
Organ Transplantation Act (NOTA), which provides that tissue cannot be bought or sold. The
law does allow for reimbursement of costs associated with the recovery, processing, and storing
of tissue and the development of tissue processing technologies. Such activities can include
research, screening and testing, sterilization processes, and precision-tooled shaping of
allographs for transplantation.
1
Regardless of their status, all tissue banks must meet the same regulatory requirements and have
the same goal of assisting in the process of making tissue safely available for transplants. Human
tissue processed and distributed for transplantation by the American Association of Tissue Banks
1
American Association of Tissue Banks, Regulation and Standards, available at https://www.aatb.org/regulatory (last visited
on Nov. 11, 2021).
REVISED: BILL: SB 516 Page 2
(AATB)-accredited tissue banks is subject to federal Food and Drug Administration regulation
and AATB’s standards.
2
Statutory Provisions Specific to Eye Banks in Florida
Part V of ch. 765, F.S., contains provisions specific to the donation and procurement of human
organs and tissues. Under this part, “procurement” is defined in s. 765.511(18), F.S., as “any
retrieval, recovery, processing, storage, or distribution of human organs or tissues for
transplantation, therapy, research, or education.”
Section 765.542, F.S., provides requirements for the certification of procurement organizations
in the state of Florida. Procurement organizations, as defined in s. 765.511(19), F.S., include
organ procurement organizations, eye banks, and tissue banks. Per s. 765.511(11), F.S., an eye
bank is “an entity that is accredited by the Eye Bank Association of America or otherwise
regulated under federal or state law to engage in the retrieval, screening, testing, processing,
storage, or distribution of human eye tissue.”
In accordance with s. 765.542(3), F.S., a person may not engage in the practice of eye
procurement in the state of Florida without being appropriately certified as an eye bank by the
Agency for Health Care Administration (AHCA). Funeral directors or direct disposers who
retrieve eye tissue for a certified eye bank are exempt from being certified as eye banks.
All procurement organizations, including eye banks, are required to file an annual report and an
annual assessment fee to the AHCA based on reported revenues from procurement and
processing activities, as provided in s. 765.544, F.S.
Chapter 873, F.S., governs the sale of anatomical matter by a person or a for-profit entity and
includes provisions related to the purchase, sale, and transfer of human organs and tissues,
including, but not limited to: the eye, cornea, kidney, liver, heart, lung, pancreas, bone, and skin.
3
Section 873.01(2), F.S., prohibits for-profit entities, or any employee of a for-profit entity, from
transferring human organs and tissues or arranging for the transfer of human organs and tissues
for valuable consideration. “Valuable consideration” does not include the reasonable costs
associated with the removal, storage, and transportation of a human organ or tissue. A violation
of this section constitutes a second-degree felony.
4
Currently there are nine for-profit eye banks and 14 not-for-profit eye banks operating in
Florida.
5
2
Id.
3
Section 873.01(3)(a), F.S.
4
Section 873.01(4), F.S. A second degree felony is punishable by up to 15 years in state prison and a fine of up to $10,000.
Sections 775.082 and 775.083, F.S. Section 775.084, F.S., provides enhanced penalties for qualifying repeat offenders.
5
Florida Health Finder (https://www.floridahealthfinder.gov/) report generated on Nov. 19, 2021, on file with Senate Health
Policy Committee staff. BILL: SB 516 Page 3
Corporate Trends in the Eye-Tissue Banking Industry
In recent years, the market for corneal tissue procurement, transport, and surgeon partnerships
has experienced somewhat of a shift from local, community-based eye banks to larger
companies. Some of these larger companies are represented by not-for-profit corporations
affiliated with for-profit “daughter” companies, which, in partnership with each other, play
defined roles in the process, with the non-profit organization recovering the tissue while the for-
profit organization processes, evaluates, and distributes the tissues to cornea surgeons.
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The for-profit status of any participant in the process has drawn criticism. However, defenders of
such partnerships respond by noting that such for-profit companies operate under the NOTA,
which states that it is illegal to buy or sell organs and tissues while it is legal to obtain reasonable
payment associated with the removal, transportation, processing, preservation, quality control,
and storage of corneas and eye tissue. Similarly, local eye banks routinely obtain payment related
to these actions. Some argue that the for-profit connection fundamentally alters the relationship
between physicians, eye banks, and donors by rendering the gift of the tissue as a commodity.
The resulting ethical debate may be crucial to the future of eye banks.
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III. Effect of Proposed Changes:
SB 516 amends ss. 765.542 and 873.01, F.S., to prohibit a for-profit eye bank from directly or
indirectly engaging in the procurement of any eye, cornea, eye tissue, or corneal tissue for use in
live-cell corneal transplantation.
The bill exempts hospitals, ambulatory surgical centers (ASC), and medical examiners from this
prohibition.
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.
6
Majid Moshirfar, Jackson L. Goldberg, et al., A paradigm shift in eye banking: how new models are challenging the status
quo, U.S. National Library of Medicine, National Institutes of Health (Dec. 27, 2018), available at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6311318/ (last visited Nov. 19, 2021).
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Id. BILL: SB 516 Page 4
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:
This bill may have an indeterminate negative fiscal impact on for-profit eye banks
operating in Florida.
C. Government Sector Impact:
None.
VI. Technical Deficiencies:
None.
VII. Related Issues:
None.
VIII. Statutes Affected:
This bill substantially amends sections 765.542 and 873.01 of the Florida Statutes.
IX. Additional Information:
A. Committee Substitute – Statement of Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
None.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.