Florida Senate - 2020                      CS for CS for SB 1516
       By the Committees on Judiciary; and Health Policy; and Senator
       590-03502-20                                          20201516c2
    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 required
   10         for making an anatomical gift to include a specified
   11         statement relating to the responsibility of payment
   12         for fees 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 deceased donor or his
  137  or her family member any fee for services relating to the
  138  procurement or donation of the deceased donor’s organs. An organ
  139  transplantation facility may not charge a living donor for
  140  services relating to the procurement or donation of his or her
  141  organs.
  142         Section 6. Section 765.53, Florida Statutes, is amended to
  143  read:
  144         (Substantial rewording of section. See
  145         s. 765.53, F.S., for present text.)
  146         765.53Organ Transplant Technical Advisory Council.—
  147         (1)CREATION AND PURPOSE.—The Organ Transplant Technical
  148  Advisory Council, an advisory council as defined in s. 20.03, is
  149  created within the agency to develop standards for measuring
  150  quality and outcomes of adult and pediatric organ transplant
  151  programs. In order to increase the number of organs available
  152  for transplantation in this state, the council shall advise the
  153  agency and the Legislature regarding the cost savings, trends,
  154  research, and protocols and procedures relating to organ
  155  donation and transplantation, including the availability of
  156  organs for donation, organ donor benefits, and access to organ
  157  transplants for persons with disabilities. Unless expressly
  158  provided otherwise in this section, the council shall operate in
  159  a manner consistent with s. 20.052.
  160         (2)MEMBERS.—
  161         (a)Voting members of the council must have technical
  162  expertise in adult or pediatric organ transplantation. The chief
  163  executive officers of the following organ transplantation
  164  facilities shall each appoint one representative, who must be an
  165  organ transplant nurse coordinator licensed under chapter 464 or
  166  an organ transplant surgeon licensed under chapter 458 or
  167  chapter 459, to serve as a voting member of the council:
  168         1.Jackson Memorial Hospital in Miami.
  169         2.Tampa General Hospital in Tampa.
  170         3.University of Florida Health Shands Hospital in
  171  Gainesville.
  172         4.AdventHealth Orlando in Orlando.
  173         5.Mayo Clinic in Jacksonville.
  174         6.Cleveland Clinic Florida in Weston.
  175         7.Largo Medical Center in Largo.
  176         8.Broward Health Medical Center in Fort Lauderdale.
  177         (b)Voting members of the council must reflect the ethnic
  178  and gender diversity of this state.
  179         (c)The Secretary of Health Care Administration shall serve
  180  as the chair and a nonvoting member of the council.
  181         (d)The Secretary of Health Care Administration shall
  182  appoint the following individuals to serve as voting members of
  183  the council:
  184         1.The State Surgeon General or his or her designee.
  185         2.A parent of a child who has had an organ transplant.
  186         3.An adult who has had an organ transplant.
  187         4.An adult patient who is on an organ transplant waiting
  188  list.
  189         5.A licensed pediatric and adult organ transplant
  190  physician for each of the following areas:
  191         a.Kidneys.
  192         b.Lungs.
  193         c.Heart.
  194         d.Liver.
  195         e.Pancreas.
  196         6.A representative from an organ procurement organization.
  197         7.An administrator of an organ transplant program.
  198         (e)Appointments made under paragraph (a) are contingent
  199  upon the hospital’s compliance with chapter 395 and rules
  200  adopted thereunder. A member of the council appointed under
  201  paragraph (a) whose hospital fails to comply with such law and
  202  rules may serve only as a nonvoting member until the hospital
  203  comes into compliance.
  204         (f)Any vacancy on the council must be filled in the same
  205  manner as the original appointment. Members are eligible for
  206  reappointment.
  207         (g)Members of the council shall serve without compensation
  208  but may be reimbursed as provided in s. 112.061 for per diem and
  209  travel expenses incurred in the performance of their duties
  210  under this section.
  211         (3)MEETINGS.—The council shall meet at least twice
  212  annually and upon the call of the chair. The council may use any
  213  method of telecommunications to conduct its meetings.
  214         (4)DUTIES.—The council shall recommend to the agency and
  215  the Legislature the standards for quality care of adult and
  216  pediatric organ transplant patients, including recommendations
  217  on minimum volume of transplants by organ type, personnel,
  218  physical plant, equipment, transportation, and data reporting
  219  for hospitals that perform organ transplants. The council may
  220  further advise the agency and the Legislature regarding research
  221  focused on improving overall organ availability and benefits for
  222  organ donors. A voting member may vote on standards related to a
  223  specific type of organ only if he or she represents a hospital
  224  that has a transplant program for that organ.
  225         (5)REPORT.—By October 1, 2021, the council shall submit a
  226  report of its recommendations to the Governor, the President of
  227  the Senate, the Speaker of the House of Representatives, the
  228  Secretary of Health Care Administration, and the State Surgeon
  229  General.
  230         (6)SOVEREIGN IMMUNITY.—Members of the council acting in
  231  good faith in the performance of their duties under this section
  232  are considered agents of the state for purposes of s. 768.28.
  233         (7)AGENCY RULES.—
  234         (a)Based on the recommendations of the council, the agency
  235  shall develop and adopt rules for organ transplant programs
  236  which, at a minimum, include all of the following:
  237         1.Quality of care standards for adult and pediatric organ
  238  transplants, including minimum volume thresholds by organ type,
  239  personnel, physical plant, equipment, transportation, and data
  240  reporting.
  241         2.Outcome and survival rate standards that meet or exceed
  242  nationally established levels of performance in organ
  243  transplantation.
  244         3.Specific steps to be taken by the agency and licensed
  245  facilities when the facilities do not meet the volume, outcome,
  246  or survival rate standards within a specified timeframe that
  247  includes the time required for detailed case reviews and the
  248  development and implementation of corrective action plans.
  249         (b)This subsection is repealed July 1, 2030, unless
  250  reviewed and saved from repeal through reenactment by the
  251  Legislature.
  252         Section 7. Subsection (3) of section 765.543, Florida
  253  Statutes, is amended to read:
  254         765.543 Organ and Tissue Procurement and Transplantation
  255  Advisory Board; creation; duties.—
  256         (3) The board shall:
  257         (a) Assist the agency, in collaboration with other relevant
  258  public or private entities, in the development of necessary
  259  professional qualifications, including, but not limited to, the
  260  continuing education, training, and performance of persons
  261  engaged in the various facets of organ and tissue procurement,
  262  processing, preservation, and distribution for transplantation;
  263         (b) Assist the agency in monitoring the appropriate and
  264  legitimate expenses associated with organ and tissue
  265  procurement, processing, and distribution for transplantation
  266  and developing methodologies to assure the uniform statewide
  267  reporting of data to facilitate the accurate and timely
  268  evaluation of the organ and tissue procurement and
  269  transplantation system;
  270         (c) Provide assistance to the Florida Medical Examiners
  271  Commission in the development of appropriate procedures and
  272  protocols to ensure the continued improvement in the approval
  273  and release of potential donors by the district medical
  274  examiners and associate medical examiners;
  275         (d) Develop with and recommend to the agency the necessary
  276  procedures and protocols required to assure that all residents
  277  of this state have reasonable access to available organ and
  278  tissue transplantation therapy and that residents of this state
  279  can be reasonably assured that the statewide procurement
  280  transplantation system is able to fulfill their organ and tissue
  281  requirements within the limits of the available supply and
  282  according to the severity of their medical condition and need;
  283  and
  284         (e) Develop with and recommend to the agency any changes to
  285  the laws of this state or administrative rules or procedures to
  286  ensure that the statewide organ and tissue procurement and
  287  transplantation system is able to function smoothly,
  288  effectively, and efficiently, in accordance with the Federal
  289  Anatomical Gift Act and in a manner that assures the residents
  290  of this state that no person or entity profits from the
  291  altruistic voluntary donation of organs or tissues. In addition
  292  to the general duties described in this subsection, by September
  293  1, 2021, the board shall submit to the agency recommendations
  294  that address all of the following:
  295         1.The frequency of communication between patients and
  296  organ transplant coordinators.
  297         2.The monitoring of each organ transplantation facility
  298  and the annual reporting and publication of relevant information
  299  regarding the statewide number of patients placed on waiting
  300  lists and the number of patients who receive transplants,
  301  aggregated by the facility.
  302         3.The establishment of a coordinated communication system
  303  between organ transplantation facilities and living organ donors
  304  for the purpose of minimizing the cost and time required for
  305  duplicative lab tests, including the sharing of lab results
  306  between facilities.
  307         4.The potential incentives for organ transplantation
  308  facilities which may be necessary to increase organ donation in
  309  this state.
  310         5.The creation of a more efficient regional or statewide
  311  living organ donor process.
  312         6.The potential opportunities and incentives for organ
  313  transplantation research.
  314         7.The best practices for organ transplantation facilities
  315  and organ procurement organizations which promote the most
  316  efficient and effective outcomes for patients.
  317         8.The monitoring of organ procurement organizations.
  318         Section 8. Section 765.548, Florida Statutes, is created to
  319  read:
  320         765.548Duties of the agency; organ donation.—
  321         (1)The agency shall do all of the following:
  322         (a)Monitor the operation of each organ transplantation
  323  facility and organ procurement organization located in this
  324  state.
  325         (b)Develop uniform statewide rules regarding organ
  326  donations. The rules must include the requirement that each
  327  hospital designate at least one employee or representative of
  328  the hospital who is educated on the protocols of the hospital
  329  and federal and state regulations regarding organ donation, to
  330  provide a clear explanation of such subjects to any patient, or
  331  a patient′s representative, who is considering posthumous or
  332  living organ donation. The rules may also include, but need not
  333  be limited to, procedures for maintaining a coordinated system
  334  of communication between organ transplantation facilities.
  335         (c)Evaluate the current protocols and procedures used by
  336  organ transplantation facilities and make recommendations for
  337  improving such protocols and procedures.
  338         (d)Establish annual reporting requirements for organ
  339  transplantation facilities and organ procurement organizations.
  340         (e)In consultation with the State Board of Education and
  341  the contractor procured by the agency pursuant to s. 765.5155,
  342  develop a curriculum for educating high school students
  343  regarding the laws of this state relating to organ donation.
  344         (2)By December 1, 2021, and each year thereafter, the
  345  agency shall publish any data and other relevant information to
  346  adequately inform patients and potential donors about organ
  347  donation and organ transplantation.
  348         Section 9. Paragraph (e) of subsection (2) of section
  349  409.815, Florida Statutes, is amended to read:
  350         409.815 Health benefits coverage; limitations.—
  351         (2) BENCHMARK BENEFITS.—In order for health benefits
  352  coverage to qualify for premium assistance payments for an
  353  eligible child under ss. 409.810-409.821, the health benefits
  354  coverage, except for coverage under Medicaid and Medikids, must
  355  include the following minimum benefits, as medically necessary.
  356         (e) Organ transplantation services.—Covered services
  357  include pretransplant, transplant, and postdischarge services
  358  and treatment of complications after transplantation for
  359  transplants deemed necessary and appropriate within the
  360  guidelines set by the Organ Transplant Technical Advisory
  361  Council under s. 765.53 or the Bone Marrow Transplant Advisory
  362  Panel under s. 627.4236.
  363         Section 10. This act shall take effect July 1, 2020.