Florida Senate - 2020                        COMMITTEE AMENDMENT
       Bill No. SB 1516
                              LEGISLATIVE ACTION                        
                    Senate             .             House              

       The Committee on Health Policy (Harrell) recommended the
    1         Senate Amendment (with title amendment)
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Section 408.0455, Florida Statutes, is amended
    6  to read:
    7         408.0455 Rules; pending proceedings.—The rules of the
    8  agency in effect on June 30, 2004, shall remain in effect and
    9  are shall be enforceable by the agency with respect to ss.
   10  408.031-408.045 until such rules are repealed or amended by the
   11  agency. Rules 59C-1.039 through 59C-1.044, Florida
   12  Administrative Code, including, but not limited to, the minimum
   13  volume standards for organ transplantation and neonatal
   14  intensive care services, remain in effect for the sole purpose
   15  of maintaining licensure requirements for the applicable
   16  services until the agency has adopted rules for the
   17  corresponding services pursuant to s. 395.1055(1)(i), Florida
   18  Statutes 2018.
   19         Section 2. Present subsections (3) and (4) of section
   20  627.6045, Florida Statutes, are redesignated as subsections (4)
   21  and (5), respectively, and a new subsection (3) is added to that
   22  section, to read:
   23         627.6045 Preexisting condition.—A health insurance policy
   24  must comply with the following:
   25         (3)A preexisting condition provision may not limit or
   26  exclude coverage solely on the basis that an insured is a living
   27  organ donor.
   28         Section 3. Paragraph (f) of subsection (1) of section
   29  765.514, Florida Statutes, is amended to read:
   30         765.514 Manner of making anatomical gifts.—
   31         (1) A person may make an anatomical gift of all or part of
   32  his or her body under s. 765.512(1) by:
   33         (f) Expressing a wish to donate in a document other than a
   34  will. The document must be signed by the donor in the presence
   35  of two witnesses who shall sign the document in the donor’s
   36  presence. If the donor cannot sign, the document may be signed
   37  for him or her at the donor’s direction and in his or her
   38  presence and the presence of two witnesses who must sign the
   39  document in the donor’s presence. Delivery of the document of
   40  gift during the donor’s lifetime is not necessary to make the
   41  gift valid. The following form of written document is sufficient
   42  for any person to make an anatomical gift for the purposes of
   43  this part:
   44                         UNIFORM DONOR CARD                        
   45  The undersigned hereby makes this anatomical gift, if medically
   46  acceptable, to take effect on death. The words and marks below
   47  indicate my desires:
   48  I give:
   49         (a) .... any needed organs, tissues, or eyes;
   50         (b) .... only the following organs, tissues, or eyes
   51            ...[Specify the organs, tissues, or eyes]...           
   52  for the purpose of transplantation, therapy, medical research,
   53  or education;
   54         (c) .... my body for anatomical study if needed.
   55  Limitations or special wishes, if any:
   56               ...(If applicable, list specific donee;             
   57        this must be arranged in advance with the donee.)...       
   59  I understand that neither I nor any member of my family is
   60  responsible for the payment of any fees associated with services
   61  relating to the procurement or donation of my organs, tissues,
   62  or eyes.
   64  Signed by the donor and the following witnesses in the presence
   65  of each other:
   66  ...(Signature of donor)...	...(Date of birth of donor)...
   67  ...(Date signed)...	...(City and State)...
   68  ...(Witness)...	...(Witness)...
   69  ...(Address)...	...(Address)...
   70         Section 4. Paragraph (b) of subsection (3) of section
   71  765.5155, Florida Statutes, is amended to read:
   72         765.5155 Donor registry; education program.—
   73         (3) The contractor shall be responsible for:
   74         (b) A continuing program to educate and inform medical
   75  professionals, law enforcement agencies and officers, other
   76  state and local government employees, high school students,
   77  minorities, and the public about state and federal the laws of
   78  this state relating to anatomical gifts and the need for
   79  anatomical gifts, including the organ donation and
   80  transplantation process.
   81         1. Existing community resources, when available, must be
   82  used to support the program and volunteers may assist the
   83  program to the maximum extent possible.
   84         2. The contractor shall coordinate with the head of a state
   85  agency or other political subdivision of the state, or his or
   86  her designee, to establish convenient times, dates, and
   87  locations for educating that entity’s employees.
   88         Section 5. Subsection (4) of section 765.517, Florida
   89  Statutes, is amended to read:
   90         765.517 Rights and duties at death.—
   91         (4) All reasonable additional expenses incurred in the
   92  procedures to preserve the donor’s organs or tissues shall be
   93  reimbursed by the procurement organization. An organ
   94  transplantation facility may not charge a donor or his or her
   95  family member any fee for services relating to the procurement
   96  or donation of his or her organs.
   97         Section 6. Subsection (3) of section 765.522, Florida
   98  Statutes, is amended to read:
   99         765.522 Duty of hospital administrators; liability of
  100  hospital administrators and procurement organizations.—
  101         (3) The agency shall establish rules and guidelines
  102  concerning the education of individuals who may be designated to
  103  perform the request and the procedures to be used in making the
  104  request, including a requirement that such individuals clearly
  105  explain to patients and living organ donors the protocols of the
  106  hospital and the federal and state regulations regarding
  107  donation. The agency is authorized to adopt rules concerning the
  108  documentation of the request, where such request is made.
  109         Section 7. Section 765.53, Florida Statutes, is amended to
  110  read:
  111         (Substantial rewording of section. See
  112         s. 765.53, F.S., for present text.)
  113         765.53Organ Transplant Technical Advisory Council.—
  114         (1)CREATION AND PURPOSE.—The Organ Transplant Technical
  115  Advisory Council, an advisory council as defined in s. 20.03, is
  116  created within the agency to develop standards for measuring
  117  quality and outcomes of adult and pediatric organ transplant
  118  programs. In order to increase the number of organs available
  119  for transplantation in this state, the council shall advise the
  120  agency and the Legislature regarding the cost savings, trends,
  121  research, and protocols and procedures relating to organ
  122  donation and transplantation, including the availability of
  123  organs for donation. Unless expressly provided otherwise in this
  124  section, the council shall operate in a manner consistent with
  125  s. 20.052.
  126         (2)MEMBERS.—
  127         (a)Voting members of the council must have technical
  128  expertise in adult or pediatric organ transplantation. The chief
  129  executive officers of the following organ transplantation
  130  facilities shall each appoint one representative, who must be an
  131  organ transplant nurse coordinator licensed under chapter 464 or
  132  an organ transplant surgeon licensed under chapter 458 or
  133  chapter 459, to serve as a voting member of the council:
  134         1.Jackson Memorial Hospital in Miami.
  135         2.Tampa General Hospital in Tampa.
  136         3.University of Florida Health Shands Hospital in
  137  Gainesville.
  138         4.AdventHealth Orlando in Orlando.
  139         5.Mayo Clinic in Jacksonville.
  140         6.Cleveland Clinic Florida in Weston.
  141         7.Largo Medical Center in Largo.
  142         8.Broward Health Medical Center in Fort Lauderdale.
  143         (b)The Secretary of Health Care Administration shall serve
  144  as the chair and a nonvoting member of the council.
  145         (c)The Secretary of Health Care Administration shall
  146  appoint the following individuals to serve as voting members of
  147  the council:
  148         1.The State Surgeon General or his or her designee.
  149         2.A parent of a child who has had an organ transplant.
  150         3.An adult who has had an organ transplant.
  151         4.An adult patient who is on an organ transplant waiting
  152  list.
  153         5.A licensed physician who practices in each of the
  154  following organ transplantation areas:
  155         a.Kidneys.
  156         b.Lungs.
  157         c.Heart.
  158         d.Liver.
  159         e.Pancreas.
  160         (d)Appointments made under paragraph (a) are contingent
  161  upon the hospital’s compliance with chapter 395 and rules
  162  adopted thereunder. A member of the council appointed under
  163  paragraph (a) whose hospital fails to comply with such law and
  164  rules may serve only as a nonvoting member until the hospital
  165  comes into compliance.
  166         (e)Any vacancy on the council must be filled in the same
  167  manner as the original appointment. Members are eligible for
  168  reappointment.
  169         (f)Members of the council shall serve without compensation
  170  but may be reimbursed as provided in s. 112.061 for per diem and
  171  travel expenses incurred in the performance of their duties
  172  under this section.
  173         (3)MEETINGS.—The council shall meet at least twice
  174  annually and upon the call of the chair. The council may use any
  175  method of telecommunications to conduct its meetings.
  176         (4)DUTIES.—The council shall recommend to the agency and
  177  the Legislature the standards for quality care of adult and
  178  pediatric organ transplant patients, including recommendations
  179  on minimum volume of transplants by organ type, personnel,
  180  physical plant, equipment, transportation, and data reporting
  181  for hospitals that perform organ transplants. The council may
  182  further advise the agency and the Legislature regarding research
  183  focused on improving overall organ availability. A voting member
  184  may vote on standards related to a specific type of organ only
  185  if he or she represents a hospital that has a transplant program
  186  for that organ.
  187         (5)REPORT.—By October 1, 2021, the council shall submit a
  188  report of its recommendations to the Governor, the President of
  189  the Senate, the Speaker of the House of Representatives, the
  190  Secretary of Health Care Administration, and the State Surgeon
  191  General.
  192         (6)SOVEREIGN IMMUNITY.—Members of the council acting in
  193  good faith in the performance of their duties under this section
  194  are considered agents of the state for purposes of s. 768.28.
  195         (7)AGENCY RULES.—
  196         (a)Based on the recommendations of the council, the agency
  197  shall develop and adopt rules for organ transplant programs
  198  which, at a minimum, include all of the following:
  199         1.Quality of care standards for adult and pediatric organ
  200  transplants, including minimum volume thresholds by organ type,
  201  personnel, physical plant, equipment, transportation, and data
  202  reporting.
  203         2.Outcome and survival rate standards that meet or exceed
  204  nationally established levels of performance in organ
  205  transplantation.
  206         3.Specific steps to be taken by the agency and licensed
  207  facilities when the facilities do not meet the volume, outcome,
  208  or survival rate standards within a specified timeframe that
  209  includes the time required for detailed case reviews and the
  210  development and implementation of corrective action plans.
  211         (b)This subsection is repealed July 1, 2030, unless
  212  reviewed and saved from repeal through reenactment by the
  213  Legislature.
  214         Section 8. Subsection (3) of section 765.543, Florida
  215  Statutes, is amended to read:
  216         765.543 Organ and Tissue Procurement and Transplantation
  217  Advisory Board; creation; duties.—
  218         (3) The board shall:
  219         (a) Assist the agency, in collaboration with other relevant
  220  public or private entities, in the development of necessary
  221  professional qualifications, including, but not limited to, the
  222  continuing education, training, and performance of persons
  223  engaged in the various facets of organ and tissue procurement,
  224  processing, preservation, and distribution for transplantation;
  225         (b) Assist the agency in monitoring the appropriate and
  226  legitimate expenses associated with organ and tissue
  227  procurement, processing, and distribution for transplantation
  228  and developing methodologies to assure the uniform statewide
  229  reporting of data to facilitate the accurate and timely
  230  evaluation of the organ and tissue procurement and
  231  transplantation system;
  232         (c) Provide assistance to the Florida Medical Examiners
  233  Commission in the development of appropriate procedures and
  234  protocols to ensure the continued improvement in the approval
  235  and release of potential donors by the district medical
  236  examiners and associate medical examiners;
  237         (d) Develop with and recommend to the agency the necessary
  238  procedures and protocols required to assure that all residents
  239  of this state have reasonable access to available organ and
  240  tissue transplantation therapy and that residents of this state
  241  can be reasonably assured that the statewide procurement
  242  transplantation system is able to fulfill their organ and tissue
  243  requirements within the limits of the available supply and
  244  according to the severity of their medical condition and need;
  245  and
  246         (e) Develop with and recommend to the agency any changes to
  247  the laws of this state or administrative rules or procedures to
  248  ensure that the statewide organ and tissue procurement and
  249  transplantation system is able to function smoothly,
  250  effectively, and efficiently, in accordance with the Federal
  251  Anatomical Gift Act and in a manner that assures the residents
  252  of this state that no person or entity profits from the
  253  altruistic voluntary donation of organs or tissues. In addition
  254  to the general duties described in this subsection, by September
  255  1, 2021, the board shall submit to the agency recommendations
  256  that address the following:
  257         1.The frequency of communication between patients and
  258  organ transplant coordinators.
  259         2.The monitoring of each organ transplantation facility
  260  and the annual reporting and publication of relevant information
  261  regarding the statewide number of patients placed on waiting
  262  lists and the number of patients who receive transplants,
  263  aggregated by the facility.
  264         3.The establishment of a coordinated communication system
  265  between organ transplantation facilities and living organ donors
  266  for the purpose of minimizing the cost and time required for
  267  duplicative lab tests, including the sharing of lab results
  268  between facilities.
  269         4.The potential incentives for organ transplantation
  270  facilities that may be necessary to increase organ donation in
  271  this state.
  272         5.The creation of a more efficient regional or statewide
  273  living organ donor process.
  274         6.The potential opportunities and incentives for organ
  275  transplantation research.
  276         7.The best practices for organ transplantation facilities
  277  and organ procurement organizations which promote the most
  278  efficient and effective outcomes for patients.
  279         8.The monitoring of organ procurement organizations.
  280         Section 9. Section 765.548, Florida Statutes, is created to
  281  read:
  282         765.548Duties of the agency; organ donation.—
  283         (1)The agency shall:
  284         (a)Monitor the operation of each organ transplantation
  285  facility and organ procurement organization located in this
  286  state.
  287         (b)Develop uniform statewide rules regarding organ
  288  donations, which may include, but need not be limited to,
  289  procedures for maintaining a coordinated system of communication
  290  between organ transplantation facilities.
  291         (c)Evaluate the current protocols and procedures used by
  292  organ transplantation facilities and make recommendations for
  293  improving such protocols and procedures.
  294         (d)Establish annual reporting requirements for organ
  295  transplantation facilities and organ procurement organizations.
  296         (e)In consultation with the State Board of Education and
  297  the contractor procured by the agency pursuant to s. 765.5155,
  298  develop a curriculum for educating high school students
  299  regarding the laws of this state relating to organ donation.
  300         (2)By December 1, 2021, and each year thereafter, the
  301  agency shall publish any data and other relevant information to
  302  adequately inform patients and potential donors about organ
  303  donation and organ transplantation.
  304         Section 10. Paragraph (e) of subsection (2) of section
  305  409.815, Florida Statutes, is amended to read:
  306         409.815 Health benefits coverage; limitations.—
  307         (2) BENCHMARK BENEFITS.—In order for health benefits
  308  coverage to qualify for premium assistance payments for an
  309  eligible child under ss. 409.810-409.821, the health benefits
  310  coverage, except for coverage under Medicaid and Medikids, must
  311  include the following minimum benefits, as medically necessary.
  312         (e) Organ transplantation services.—Covered services
  313  include pretransplant, transplant, and postdischarge services
  314  and treatment of complications after transplantation for
  315  transplants deemed necessary and appropriate within the
  316  guidelines set by the Organ Transplant Technical Advisory
  317  Council under s. 765.53 or the Bone Marrow Transplant Advisory
  318  Panel under s. 627.4236.
  319         Section 11. This act shall take effect July 1, 2020.
  321  ================= T I T L E  A M E N D M E N T ================
  322  And the title is amended as follows:
  323         Delete everything before the enacting clause
  324  and insert:
  325                        A bill to be entitled                      
  326         An act relating to organ donation; amending s.
  327         408.0455, F.S.; revising a provision relating to the
  328         operation of certain rules adopted by the Agency for
  329         Health Care Administration; amending s. 627.6045,
  330         F.S.; prohibiting a health insurance policy from
  331         limiting or excluding coverage solely on the basis
  332         that an insured is a living organ donor; amending s.
  333         765.514, F.S.; revising a written document for making
  334         an anatomical gift to include a specified statement
  335         relating to the responsibility of payment for fees
  336         associated with certain services; amending s.
  337         765.5155, F.S.; revising the responsibilities of a
  338         contractor procured by the agency for the purpose of
  339         educating and informing the public about anatomical
  340         gifts; amending s. 765.517, F.S.; prohibiting an organ
  341         transplantation facility from charging a donor or his
  342         or her family member any fee for services relating to
  343         the procurement or donation of organs; amending s.
  344         765.522, F.S.; revising a requirement that the agency
  345         establish rules and guidelines relating to the
  346         education of certain individuals designated to perform
  347         certain organ donation procedures; amending s. 765.53,
  348         F.S.; requiring the agency to establish the Organ
  349         Transplant Technical Advisory Council for a specified
  350         purpose; providing for membership, meetings, and
  351         duties of the council; requiring the council to submit
  352         a report to the Governor, the Legislature, the
  353         Secretary of Health Care Administration, and the State
  354         Surgeon General by a specified date; providing for
  355         sovereign immunity of council members under certain
  356         circumstances; requiring the agency to adopt specified
  357         rules based on the council’s recommendations;
  358         providing for future legislative review and repeal of
  359         certain provisions; amending s. 765.543, F.S.;
  360         revising the duties of the Organ and Tissue
  361         Procurement and Transplantation Advisory Board;
  362         requiring the board to submit certain recommendations
  363         to the agency by a specified date; creating s.
  364         765.548, F.S.; providing additional duties of the
  365         agency relating to organ transplantation facilities
  366         and organ procurement organizations and organ donation
  367         procedures and protocols; requiring the agency to
  368         publish certain data and information by a specified
  369         date and annually thereafter; amending s. 409.815,
  370         F.S.; conforming a provision to changes made by the
  371         act; providing an effective date.