Florida Senate - 2020                             CS for SB 1516
       By the Committee on Health Policy; and Senator Harrell
       588-02737-20                                          20201516c1
    1                        A bill to be entitled                      
    2         An act relating to organ donation; amending s.
    3         408.0455, F.S.; revising a provision relating to the
    4         operation of certain rules adopted by the Agency for
    5         Health Care Administration; amending s. 627.6045,
    6         F.S.; prohibiting a health insurance policy from
    7         limiting or excluding coverage solely on the basis
    8         that an insured is a living organ donor; amending s.
    9         765.514, F.S.; revising a written document for making
   10         an anatomical gift to include a specified statement
   11         relating to the responsibility of payment for fees
   12         associated with certain services; amending s.
   13         765.5155, F.S.; revising the responsibilities of a
   14         contractor procured by the agency for the purpose of
   15         educating and informing the public about anatomical
   16         gifts; amending s. 765.517, F.S.; prohibiting an organ
   17         transplantation facility from charging a donor or his
   18         or her family member any fee for services relating to
   19         the procurement or donation of organs; amending s.
   20         765.53, F.S.; requiring the agency to establish the
   21         Organ Transplant Technical Advisory Council for a
   22         specified purpose; providing for membership, meetings,
   23         and duties of the council; requiring the council to
   24         submit a report to the Governor, the Legislature, the
   25         Secretary of Health Care Administration, and the State
   26         Surgeon General by a specified date; providing for
   27         sovereign immunity of council members under certain
   28         circumstances; requiring the agency to adopt specified
   29         rules based on the council’s recommendations;
   30         providing for future legislative review and repeal of
   31         certain provisions; amending s. 765.543, F.S.;
   32         revising the duties of the Organ and Tissue
   33         Procurement and Transplantation Advisory Board;
   34         requiring the board to submit certain recommendations
   35         to the agency by a specified date; creating s.
   36         765.548, F.S.; providing additional duties of the
   37         agency relating to organ transplantation facilities
   38         and organ procurement organizations and organ donation
   39         procedures and protocols; requiring the agency to
   40         publish certain data and information by a specified
   41         date and annually thereafter; amending s. 409.815,
   42         F.S.; conforming a provision to changes made by the
   43         act; providing an effective date.
   45  Be It Enacted by the Legislature of the State of Florida:
   47         Section 1. Section 408.0455, Florida Statutes, is amended
   48  to read:
   49         408.0455 Rules; pending proceedings.—The rules of the
   50  agency in effect on June 30, 2004, shall remain in effect and
   51  are shall be enforceable by the agency with respect to ss.
   52  408.031-408.045 until such rules are repealed or amended by the
   53  agency. Rules 59C-1.039 through 59C-1.044, Florida
   54  Administrative Code, including, but not limited to, the minimum
   55  volume standards for organ transplantation and neonatal
   56  intensive care services, remain in effect for the sole purpose
   57  of maintaining licensure requirements for the applicable
   58  services until the agency has adopted rules for the
   59  corresponding services pursuant to s. 395.1055(1)(i), Florida
   60  Statutes 2018.
   61         Section 2. Present subsections (3) and (4) of section
   62  627.6045, Florida Statutes, are redesignated as subsections (4)
   63  and (5), respectively, and a new subsection (3) is added to that
   64  section, to read:
   65         627.6045 Preexisting condition.—A health insurance policy
   66  must comply with the following:
   67         (3)A preexisting condition provision may not limit or
   68  exclude coverage solely on the basis that an insured is a living
   69  organ donor.
   70         Section 3. Paragraph (f) of subsection (1) of section
   71  765.514, Florida Statutes, is amended to read:
   72         765.514 Manner of making anatomical gifts.—
   73         (1) A person may make an anatomical gift of all or part of
   74  his or her body under s. 765.512(1) by:
   75         (f) Expressing a wish to donate in a document other than a
   76  will. The document must be signed by the donor in the presence
   77  of two witnesses who shall sign the document in the donor’s
   78  presence. If the donor cannot sign, the document may be signed
   79  for him or her at the donor’s direction and in his or her
   80  presence and the presence of two witnesses who must sign the
   81  document in the donor’s presence. Delivery of the document of
   82  gift during the donor’s lifetime is not necessary to make the
   83  gift valid. The following form of written document is sufficient
   84  for any person to make an anatomical gift for the purposes of
   85  this part:
   86                         UNIFORM DONOR CARD                        
   87  The undersigned hereby makes this anatomical gift, if medically
   88  acceptable, to take effect on death. The words and marks below
   89  indicate my desires:
   90  I give:
   91         (a) .... any needed organs, tissues, or eyes;
   92         (b) .... only the following organs, tissues, or eyes
   93            ...[Specify the organs, tissues, or eyes]...           
   94  for the purpose of transplantation, therapy, medical research,
   95  or education;
   96         (c) .... my body for anatomical study if needed.
   97  Limitations or special wishes, if any:
   98               ...(If applicable, list specific donee;             
   99        this must be arranged in advance with the donee.)...       
  101  I understand that neither I nor any member of my family is
  102  responsible for the payment of any fees associated with services
  103  relating to the procurement or donation of my organs, tissues,
  104  or eyes.
  106  Signed by the donor and the following witnesses in the presence
  107  of each other:
  108  ...(Signature of donor)...	...(Date of birth of donor)...
  109  ...(Date signed)...	...(City and State)...
  110  ...(Witness)...	...(Witness)...
  111  ...(Address)...	...(Address)...
  112         Section 4. Paragraph (b) of subsection (3) of section
  113  765.5155, Florida Statutes, is amended to read:
  114         765.5155 Donor registry; education program.—
  115         (3) The contractor shall be responsible for:
  116         (b) A continuing program to educate and inform medical
  117  professionals, law enforcement agencies and officers, other
  118  state and local government employees, high school students,
  119  minorities, and the public about state and federal the laws of
  120  this state relating to anatomical gifts and the need for
  121  anatomical gifts, including the organ donation and
  122  transplantation process.
  123         1. Existing community resources, when available, must be
  124  used to support the program and volunteers may assist the
  125  program to the maximum extent possible.
  126         2. The contractor shall coordinate with the head of a state
  127  agency or other political subdivision of the state, or his or
  128  her designee, to establish convenient times, dates, and
  129  locations for educating that entity’s employees.
  130         Section 5. Subsection (4) of section 765.517, Florida
  131  Statutes, is amended to read:
  132         765.517 Rights and duties at death.—
  133         (4) All reasonable additional expenses incurred in the
  134  procedures to preserve the donor’s organs or tissues shall be
  135  reimbursed by the procurement organization. An organ
  136  transplantation facility may not charge a donor or his or her
  137  family member any fee for services relating to the procurement
  138  or donation of his or her organs.
  139         Section 6. Section 765.53, Florida Statutes, is amended to
  140  read:
  141         (Substantial rewording of section. See
  142         s. 765.53, F.S., for present text.)
  143         765.53Organ Transplant Technical Advisory Council.—
  144         (1)CREATION AND PURPOSE.—The Organ Transplant Technical
  145  Advisory Council, an advisory council as defined in s. 20.03, is
  146  created within the agency to develop standards for measuring
  147  quality and outcomes of adult and pediatric organ transplant
  148  programs. In order to increase the number of organs available
  149  for transplantation in this state, the council shall advise the
  150  agency and the Legislature regarding the cost savings, trends,
  151  research, and protocols and procedures relating to organ
  152  donation and transplantation, including the availability of
  153  organs for donation. Unless expressly provided otherwise in this
  154  section, the council shall operate in a manner consistent with
  155  s. 20.052.
  156         (2)MEMBERS.—
  157         (a)Voting members of the council must have technical
  158  expertise in adult or pediatric organ transplantation. The chief
  159  executive officers of the following organ transplantation
  160  facilities shall each appoint one representative, who must be an
  161  organ transplant nurse coordinator licensed under chapter 464 or
  162  an organ transplant surgeon licensed under chapter 458 or
  163  chapter 459, to serve as a voting member of the council:
  164         1.Jackson Memorial Hospital in Miami.
  165         2.Tampa General Hospital in Tampa.
  166         3.University of Florida Health Shands Hospital in
  167  Gainesville.
  168         4.AdventHealth Orlando in Orlando.
  169         5.Mayo Clinic in Jacksonville.
  170         6.Cleveland Clinic Florida in Weston.
  171         7.Largo Medical Center in Largo.
  172         8.Broward Health Medical Center in Fort Lauderdale.
  173         (b)Voting members of the council must reflect the ethnic
  174  and gender diversity of this state.
  175         (c)The Secretary of Health Care Administration shall serve
  176  as the chair and a nonvoting member of the council.
  177         (d)The Secretary of Health Care Administration shall
  178  appoint the following individuals to serve as voting members of
  179  the council:
  180         1.The State Surgeon General or his or her designee.
  181         2.A parent of a child who has had an organ transplant.
  182         3.An adult who has had an organ transplant.
  183         4.An adult patient who is on an organ transplant waiting
  184  list.
  185         5.A licensed physician who practices in each of the
  186  following organ transplantation areas:
  187         a.Kidneys.
  188         b.Lungs.
  189         c.Heart.
  190         d.Liver.
  191         e.Pancreas.
  192         (e)Appointments made under paragraph (a) are contingent
  193  upon the hospital’s compliance with chapter 395 and rules
  194  adopted thereunder. A member of the council appointed under
  195  paragraph (a) whose hospital fails to comply with such law and
  196  rules may serve only as a nonvoting member until the hospital
  197  comes into compliance.
  198         (f)Any vacancy on the council must be filled in the same
  199  manner as the original appointment. Members are eligible for
  200  reappointment.
  201         (g)Members of the council shall serve without compensation
  202  but may be reimbursed as provided in s. 112.061 for per diem and
  203  travel expenses incurred in the performance of their duties
  204  under this section.
  205         (3)MEETINGS.—The council shall meet at least twice
  206  annually and upon the call of the chair. The council may use any
  207  method of telecommunications to conduct its meetings.
  208         (4)DUTIES.—The council shall recommend to the agency and
  209  the Legislature the standards for quality care of adult and
  210  pediatric organ transplant patients, including recommendations
  211  on minimum volume of transplants by organ type, personnel,
  212  physical plant, equipment, transportation, and data reporting
  213  for hospitals that perform organ transplants. The council may
  214  further advise the agency and the Legislature regarding research
  215  focused on improving overall organ availability. A voting member
  216  may vote on standards related to a specific type of organ only
  217  if he or she represents a hospital that has a transplant program
  218  for that organ.
  219         (5)REPORT.—By October 1, 2021, the council shall submit a
  220  report of its recommendations to the Governor, the President of
  221  the Senate, the Speaker of the House of Representatives, the
  222  Secretary of Health Care Administration, and the State Surgeon
  223  General.
  224         (6)SOVEREIGN IMMUNITY.—Members of the council acting in
  225  good faith in the performance of their duties under this section
  226  are considered agents of the state for purposes of s. 768.28.
  227         (7)AGENCY RULES.—
  228         (a)Based on the recommendations of the council, the agency
  229  shall develop and adopt rules for organ transplant programs
  230  which, at a minimum, include all of the following:
  231         1.Quality of care standards for adult and pediatric organ
  232  transplants, including minimum volume thresholds by organ type,
  233  personnel, physical plant, equipment, transportation, and data
  234  reporting.
  235         2.Outcome and survival rate standards that meet or exceed
  236  nationally established levels of performance in organ
  237  transplantation.
  238         3.Specific steps to be taken by the agency and licensed
  239  facilities when the facilities do not meet the volume, outcome,
  240  or survival rate standards within a specified timeframe that
  241  includes the time required for detailed case reviews and the
  242  development and implementation of corrective action plans.
  243         (b)This subsection is repealed July 1, 2030, unless
  244  reviewed and saved from repeal through reenactment by the
  245  Legislature.
  246         Section 7. Subsection (3) of section 765.543, Florida
  247  Statutes, is amended to read:
  248         765.543 Organ and Tissue Procurement and Transplantation
  249  Advisory Board; creation; duties.—
  250         (3) The board shall:
  251         (a) Assist the agency, in collaboration with other relevant
  252  public or private entities, in the development of necessary
  253  professional qualifications, including, but not limited to, the
  254  continuing education, training, and performance of persons
  255  engaged in the various facets of organ and tissue procurement,
  256  processing, preservation, and distribution for transplantation;
  257         (b) Assist the agency in monitoring the appropriate and
  258  legitimate expenses associated with organ and tissue
  259  procurement, processing, and distribution for transplantation
  260  and developing methodologies to assure the uniform statewide
  261  reporting of data to facilitate the accurate and timely
  262  evaluation of the organ and tissue procurement and
  263  transplantation system;
  264         (c) Provide assistance to the Florida Medical Examiners
  265  Commission in the development of appropriate procedures and
  266  protocols to ensure the continued improvement in the approval
  267  and release of potential donors by the district medical
  268  examiners and associate medical examiners;
  269         (d) Develop with and recommend to the agency the necessary
  270  procedures and protocols required to assure that all residents
  271  of this state have reasonable access to available organ and
  272  tissue transplantation therapy and that residents of this state
  273  can be reasonably assured that the statewide procurement
  274  transplantation system is able to fulfill their organ and tissue
  275  requirements within the limits of the available supply and
  276  according to the severity of their medical condition and need;
  277  and
  278         (e) Develop with and recommend to the agency any changes to
  279  the laws of this state or administrative rules or procedures to
  280  ensure that the statewide organ and tissue procurement and
  281  transplantation system is able to function smoothly,
  282  effectively, and efficiently, in accordance with the Federal
  283  Anatomical Gift Act and in a manner that assures the residents
  284  of this state that no person or entity profits from the
  285  altruistic voluntary donation of organs or tissues. In addition
  286  to the general duties described in this subsection, by September
  287  1, 2021, the board shall submit to the agency recommendations
  288  that address the following:
  289         1.The frequency of communication between patients and
  290  organ transplant coordinators.
  291         2.The monitoring of each organ transplantation facility
  292  and the annual reporting and publication of relevant information
  293  regarding the statewide number of patients placed on waiting
  294  lists and the number of patients who receive transplants,
  295  aggregated by the facility.
  296         3.The establishment of a coordinated communication system
  297  between organ transplantation facilities and living organ donors
  298  for the purpose of minimizing the cost and time required for
  299  duplicative lab tests, including the sharing of lab results
  300  between facilities.
  301         4.The potential incentives for organ transplantation
  302  facilities that may be necessary to increase organ donation in
  303  this state.
  304         5.The creation of a more efficient regional or statewide
  305  living organ donor process.
  306         6.The potential opportunities and incentives for organ
  307  transplantation research.
  308         7.The best practices for organ transplantation facilities
  309  and organ procurement organizations which promote the most
  310  efficient and effective outcomes for patients.
  311         8.The monitoring of organ procurement organizations.
  312         Section 8. Section 765.548, Florida Statutes, is created to
  313  read:
  314         765.548Duties of the agency; organ donation.—
  315         (1)The agency shall:
  316         (a)Monitor the operation of each organ transplantation
  317  facility and organ procurement organization located in this
  318  state.
  319         (b)Develop uniform statewide rules regarding organ
  320  donations. The rules must include the requirement that each
  321  hospital designate at least one employee or representative of
  322  the hospital who is educated on the protocols of the hospital
  323  and federal and state regulations regarding organ donation, to
  324  provide a clear explanation of such subjects to any patient, or
  325  a patient′s representative, who is considering posthumous or
  326  living organ donation. The rules may also include, but need not
  327  be limited to, procedures for maintaining a coordinated system
  328  of communication between organ transplantation facilities.
  329         (c)Evaluate the current protocols and procedures used by
  330  organ transplantation facilities and make recommendations for
  331  improving such protocols and procedures.
  332         (d)Establish annual reporting requirements for organ
  333  transplantation facilities and organ procurement organizations.
  334         (e)In consultation with the State Board of Education and
  335  the contractor procured by the agency pursuant to s. 765.5155,
  336  develop a curriculum for educating high school students
  337  regarding the laws of this state relating to organ donation.
  338         (2)By December 1, 2021, and each year thereafter, the
  339  agency shall publish any data and other relevant information to
  340  adequately inform patients and potential donors about organ
  341  donation and organ transplantation.
  342         Section 9. Paragraph (e) of subsection (2) of section
  343  409.815, Florida Statutes, is amended to read:
  344         409.815 Health benefits coverage; limitations.—
  345         (2) BENCHMARK BENEFITS.—In order for health benefits
  346  coverage to qualify for premium assistance payments for an
  347  eligible child under ss. 409.810-409.821, the health benefits
  348  coverage, except for coverage under Medicaid and Medikids, must
  349  include the following minimum benefits, as medically necessary.
  350         (e) Organ transplantation services.—Covered services
  351  include pretransplant, transplant, and postdischarge services
  352  and treatment of complications after transplantation for
  353  transplants deemed necessary and appropriate within the
  354  guidelines set by the Organ Transplant Technical Advisory
  355  Council under s. 765.53 or the Bone Marrow Transplant Advisory
  356  Panel under s. 627.4236.
  357         Section 10. This act shall take effect July 1, 2020.