Florida Senate - 2020               CS for CS for CS for SB 1516
       By the Committees on Rules; Judiciary; and Health Policy; and
       Senator Harrell
       595-04236-20                                          20201516c3
    1                        A bill to be entitled                      
    2         An act relating to organ donation; amending s.
    3         381.0041, F.S.; providing that it is a felony for
    4         certain persons who are infected with human
    5         immunodeficiency virus to donate blood, plasma,
    6         organs, skin, or other human tissue for use in another
    7         person, with an exception; amending s. 395.1055, F.S.;
    8         requiring the Agency for Health Care Administration to
    9         adopt by rule specified minimum standards for certain
   10         organ transplants; providing for the expiration of the
   11         requirement upon the adoption of specified rules;
   12         amending s. 627.6045, F.S.; prohibiting a health
   13         insurance policy from limiting or excluding coverage
   14         solely on the basis that an insured is a living organ
   15         donor; amending s. 765.514, F.S.; revising a written
   16         document required for making an anatomical gift to
   17         include a specified statement relating to the
   18         responsibility of payment for fees associated with
   19         certain services; amending s. 765.5155, F.S.; revising
   20         the responsibilities of a contractor procured by the
   21         agency for the purpose of educating and informing the
   22         public about anatomical gifts; amending s. 765.517,
   23         F.S.; prohibiting an organ procurement organization
   24         from charging a deceased donor or his or her family
   25         member any fee for services relating to the
   26         procurement or donation of organs; creating s.
   27         765.5175, F.S.; prohibiting an organ transplantation
   28         facility from charging a living donor or his or her
   29         family member any fee for services relating to the
   30         procurement or donation of organs, with an exception;
   31         amending s. 765.53, F.S.; requiring the agency to
   32         establish the Organ Transplant Technical Advisory
   33         Council for a specified purpose; providing for
   34         membership, meetings, and duties of the council;
   35         requiring the council to submit a report to the
   36         Governor, the Legislature, the Secretary of Health
   37         Care Administration, and the State Surgeon General by
   38         a specified date; providing for sovereign immunity of
   39         council members under certain circumstances; requiring
   40         the agency to adopt specified rules based on the
   41         council’s recommendations; providing for future
   42         legislative review and repeal of certain provisions;
   43         amending s. 765.543, F.S.; revising the duties of the
   44         Organ and Tissue Procurement and Transplantation
   45         Advisory Board; requiring the board to submit certain
   46         recommendations to the agency by a specified date;
   47         creating s. 765.548, F.S.; providing additional duties
   48         of the agency relating to organ transplantation
   49         facilities and organ procurement organizations and
   50         organ donation procedures and protocols; requiring the
   51         agency to publish certain data and information by a
   52         specified date and annually thereafter; amending s.
   53         409.815, F.S.; conforming a provision to changes made
   54         by the act; providing an effective date.
   56  Be It Enacted by the Legislature of the State of Florida:
   58         Section 1. Paragraph (b) of subsection (11) of section
   59  381.0041, Florida Statutes, is amended to read:
   60         381.0041 Donation and transfer of human tissue; testing
   61  requirements.—
   62         (11)
   63         (b) Any person who has human immunodeficiency virus
   64  infection, who knows he or she is infected with human
   65  immunodeficiency virus, and who has been informed that he or she
   66  may communicate this disease by donating blood, plasma, organs,
   67  skin, or other human tissue who donates blood, plasma, organs,
   68  skin, or other human tissue for use in another person commits is
   69  guilty of a felony of the third degree, punishable as provided
   70  in s. 775.082, s. 775.083, or s. 775.084. This paragraph does
   71  not apply if the donation is made specifically for a recipient
   72  who is infected with human immunodeficiency virus and who knows
   73  that the donor is infected with human immunodeficiency virus.
   74         Section 2. Paragraph (j) is added to subsection (1) of
   75  section 395.1055, Florida Statutes, to read:
   76         395.1055 Rules and enforcement.—
   77         (1) The agency shall adopt rules pursuant to ss. 120.536(1)
   78  and 120.54 to implement the provisions of this part, which shall
   79  include reasonable and fair minimum standards for ensuring that:
   80         (j)Hospitals providing organ transplants meet the
   81  following minimum volume of transplants by organ type:
   82         1.For heart transplants, performance of at least 12 such
   83  transplants per year.
   84         2.For liver transplants, performance of at least 5 such
   85  transplants per biennium.
   86         3.For adult kidney transplants, performance of at least 15
   87  such transplants per biennium.
   88         4.For pediatric kidney transplants, performance of at
   89  least 5 such transplants per biennium.
   90         5.For adult allogenic and autologous bone marrow
   91  transplants, performance of at least 10 transplants per year of
   92  each such transplant it offers.
   93         6.For pediatric allogenic and autologous bone marrow
   94  transplants, performance of at least 10 transplants per year of
   95  each such transplant it offers.
   96         7.For any other transplant type not specified in
   97  subparagraphs 1.-6., performance of at least 10 transplants of
   98  such transplant per year.
  100  This paragraph expires upon the agency’s adoption of rules
  101  pursuant to s. 765.53(7).
  102         Section 3. Present subsections (3) and (4) of section
  103  627.6045, Florida Statutes, are redesignated as subsections (4)
  104  and (5), respectively, and a new subsection (3) is added to that
  105  section, to read:
  106         627.6045 Preexisting condition.—A health insurance policy
  107  must comply with the following:
  108         (3)A preexisting condition provision may not limit or
  109  exclude coverage solely on the basis that an insured is a living
  110  organ donor.
  111         Section 4. Paragraph (f) of subsection (1) of section
  112  765.514, Florida Statutes, is amended to read:
  113         765.514 Manner of making anatomical gifts.—
  114         (1) A person may make an anatomical gift of all or part of
  115  his or her body under s. 765.512(1) by:
  116         (f) Expressing a wish to donate in a document other than a
  117  will. The document must be signed by the donor in the presence
  118  of two witnesses who shall sign the document in the donor’s
  119  presence. If the donor cannot sign, the document may be signed
  120  for him or her at the donor’s direction and in his or her
  121  presence and the presence of two witnesses who must sign the
  122  document in the donor’s presence. Delivery of the document of
  123  gift during the donor’s lifetime is not necessary to make the
  124  gift valid. The following form of written document is sufficient
  125  for any person to make an anatomical gift for the purposes of
  126  this part:
  127                         UNIFORM DONOR CARD                        
  128  The undersigned hereby makes this anatomical gift, if medically
  129  acceptable, to take effect on death. The words and marks below
  130  indicate my desires:
  131  I give:
  132         (a) .... any needed organs, tissues, or eyes;
  133         (b) .... only the following organs, tissues, or eyes
  134            ...[Specify the organs, tissues, or eyes]...           
  135  for the purpose of transplantation, therapy, medical research,
  136  or education;
  137         (c) .... my body for anatomical study if needed.
  138  Limitations or special wishes, if any:
  139               ...(If applicable, list specific donee;             
  140        this must be arranged in advance with the donee.)...       
  142  I understand that neither I nor any member of my family is
  143  responsible for the payment of any fees associated with services
  144  relating to the procurement or donation of my organs, tissues,
  145  or eyes.
  147  Signed by the donor and the following witnesses in the presence
  148  of each other:
  149  ...(Signature of donor)...	...(Date of birth of donor)...
  150  ...(Date signed)...	...(City and State)...
  151  ...(Witness)...	...(Witness)...
  152  ...(Address)...	...(Address)...
  153         Section 5. Paragraph (b) of subsection (3) of section
  154  765.5155, Florida Statutes, is amended to read:
  155         765.5155 Donor registry; education program.—
  156         (3) The contractor shall be responsible for:
  157         (b) A continuing program to educate and inform medical
  158  professionals, law enforcement agencies and officers, other
  159  state and local government employees, high school students,
  160  minorities, and the public about state and federal the laws of
  161  this state relating to anatomical gifts and the need for
  162  anatomical gifts, including the organ donation and
  163  transplantation process.
  164         1. Existing community resources, when available, must be
  165  used to support the program and volunteers may assist the
  166  program to the maximum extent possible.
  167         2. The contractor shall coordinate with the head of a state
  168  agency or other political subdivision of the state, or his or
  169  her designee, to establish convenient times, dates, and
  170  locations for educating that entity’s employees.
  171         Section 6. Subsection (4) of section 765.517, Florida
  172  Statutes, is amended to read:
  173         765.517 Rights and duties at death.—
  174         (4) All reasonable additional expenses incurred in the
  175  procedures to preserve the donor’s organs or tissues shall be
  176  reimbursed by the procurement organization. An organ procurement
  177  organization may not charge a deceased donor or his or her
  178  family member any fee for services relating to the procurement
  179  or donation of the deceased donor’s organs.
  180         Section 7. Section 765.5175, Florida Statutes, is created
  181  to read:
  182         765.5175Rights and duties of living donors.—An organ
  183  transplantation facility may not charge a living donor or his or
  184  her family member, other than a family member who is the
  185  recipient of the organ, any fee for services relating to the
  186  procurement or donation of his or her organs.
  187         Section 8. Section 765.53, Florida Statutes, is amended to
  188  read:
  189         (Substantial rewording of section. See
  190         s. 765.53, F.S., for present text.)
  191         765.53Organ Transplant Technical Advisory Council.—
  192         (1)CREATION AND PURPOSE.—The Organ Transplant Technical
  193  Advisory Council, an advisory council as defined in s. 20.03, is
  194  created within the agency to develop standards for measuring
  195  quality and outcomes of adult and pediatric organ transplant
  196  programs. In order to increase the number of organs available
  197  for transplantation in this state, the council shall advise the
  198  agency and the Legislature regarding the cost savings, trends,
  199  research, and protocols and procedures relating to organ
  200  donation and transplantation, including the availability of
  201  organs for donation, organ donor benefits, and access to organ
  202  transplants for persons with disabilities. Unless expressly
  203  provided otherwise in this section, the council shall operate in
  204  a manner consistent with s. 20.052.
  205         (2)MEMBERS.—
  206         (a)Voting members of the council must have technical
  207  expertise in adult or pediatric organ transplantation. The chief
  208  executive officers of the following organ transplantation
  209  facilities shall each appoint one representative, who must be an
  210  organ transplant nurse coordinator licensed under chapter 464 or
  211  an organ transplant surgeon licensed under chapter 458 or
  212  chapter 459, to serve as a voting member of the council:
  213         1.Jackson Memorial Hospital in Miami.
  214         2.Tampa General Hospital in Tampa.
  215         3.University of Florida Health Shands Hospital in
  216  Gainesville.
  217         4.AdventHealth Orlando in Orlando.
  218         5.Mayo Clinic in Jacksonville.
  219         6.Cleveland Clinic Florida in Weston.
  220         7.Largo Medical Center in Largo.
  221         8.Broward Health Medical Center in Fort Lauderdale.
  222         (b)Voting members of the council must reflect the ethnic
  223  and gender diversity of this state.
  224         (c)The Secretary of Health Care Administration, or his or
  225  her designee, shall serve as the chair and as a nonvoting member
  226  of the council.
  227         (d)The Secretary of Health Care Administration shall
  228  appoint the following individuals to serve as voting members of
  229  the council:
  230         1.The State Surgeon General or his or her designee.
  231         2.A parent of a child who has had an organ transplant.
  232         3.An adult who has had an organ transplant.
  233         4.An adult patient who is on an organ transplant waiting
  234  list.
  235         5.A licensed organ transplant physician for each of the
  236  following areas:
  237         a.Kidneys.
  238         b.Lungs.
  239         c.Heart.
  240         d.Liver.
  241         e.Pancreas.
  242         6.A representative from an organ procurement organization.
  243         7.An administrator of an organ transplant program.
  244         (e)Appointments made under paragraph (a) are contingent
  245  upon the hospital’s compliance with chapter 395 and rules
  246  adopted thereunder. A member of the council appointed under
  247  paragraph (a) whose hospital fails to comply with such law and
  248  rules may serve only as a nonvoting member until the hospital
  249  comes into compliance.
  250         (f)Any vacancy on the council must be filled in the same
  251  manner as the original appointment. Members are eligible for
  252  reappointment.
  253         (g)Members of the council shall serve without compensation
  254  but may be reimbursed as provided in s. 112.061 for per diem and
  255  travel expenses incurred in the performance of their duties
  256  under this section.
  257         (3)MEETINGS.—The council shall meet at least twice
  258  annually and upon the call of the chair. The council may use any
  259  method of telecommunications to conduct its meetings.
  260         (4)DUTIES.—The council shall recommend to the agency and
  261  the Legislature the standards for quality care of adult and
  262  pediatric organ transplant patients, including recommendations
  263  on minimum volume of transplants by organ type, personnel,
  264  physical plant, equipment, transportation, and data reporting
  265  for hospitals that perform organ transplants. The council may
  266  further advise the agency and the Legislature regarding research
  267  focused on improving overall organ availability and benefits for
  268  organ donors. A voting member may vote on standards related to a
  269  specific type of organ only if he or she represents a hospital
  270  that has a transplant program for that organ.
  271         (5)REPORT.—By October 1, 2021, the council shall submit a
  272  report of its recommendations to the Governor, the President of
  273  the Senate, the Speaker of the House of Representatives, the
  274  Secretary of Health Care Administration, and the State Surgeon
  275  General.
  276         (6)SOVEREIGN IMMUNITY.—Members of the council acting in
  277  good faith in the performance of their duties under this section
  278  are considered agents of the state for purposes of s. 768.28.
  279         (7)AGENCY RULES.—
  280         (a)Based on the recommendations of the council, the agency
  281  shall develop and adopt rules for organ transplant programs
  282  which, at a minimum, include all of the following:
  283         1.Quality of care standards for adult and pediatric organ
  284  transplants, including minimum volume thresholds by organ type;
  285  personnel; physical plant; equipment; transportation; and data
  286  reporting.
  287         2.Outcome and survival rate standards that meet or exceed
  288  nationally established levels of performance in organ
  289  transplantation.
  290         3.Specific steps to be taken by the agency and licensed
  291  facilities when the facilities do not meet the volume, outcome,
  292  or survival rate standards within a specified timeframe that
  293  includes the time required for detailed case reviews and the
  294  development and implementation of corrective action plans.
  295         (b)This subsection is repealed July 1, 2030, unless
  296  reviewed and saved from repeal through reenactment by the
  297  Legislature.
  298         Section 9. Subsection (3) of section 765.543, Florida
  299  Statutes, is amended to read:
  300         765.543 Organ and Tissue Procurement and Transplantation
  301  Advisory Board; creation; duties.—
  302         (3) The board shall:
  303         (a) Assist the agency, in collaboration with other relevant
  304  public or private entities, in the development of necessary
  305  professional qualifications, including, but not limited to, the
  306  continuing education, training, and performance of persons
  307  engaged in the various facets of organ and tissue procurement,
  308  processing, preservation, and distribution for transplantation;
  309         (b) Assist the agency in monitoring the appropriate and
  310  legitimate expenses associated with organ and tissue
  311  procurement, processing, and distribution for transplantation
  312  and developing methodologies to assure the uniform statewide
  313  reporting of data to facilitate the accurate and timely
  314  evaluation of the organ and tissue procurement and
  315  transplantation system;
  316         (c) Provide assistance to the Florida Medical Examiners
  317  Commission in the development of appropriate procedures and
  318  protocols to ensure the continued improvement in the approval
  319  and release of potential donors by the district medical
  320  examiners and associate medical examiners;
  321         (d) Develop with and recommend to the agency the necessary
  322  procedures and protocols required to assure that all residents
  323  of this state have reasonable access to available organ and
  324  tissue transplantation therapy and that residents of this state
  325  can be reasonably assured that the statewide procurement
  326  transplantation system is able to fulfill their organ and tissue
  327  requirements within the limits of the available supply and
  328  according to the severity of their medical condition and need;
  329  and
  330         (e) Develop with and recommend to the agency any changes to
  331  the laws of this state or administrative rules or procedures to
  332  ensure that the statewide organ and tissue procurement and
  333  transplantation system is able to function smoothly,
  334  effectively, and efficiently, in accordance with the Federal
  335  Anatomical Gift Act and in a manner that assures the residents
  336  of this state that no person or entity profits from the
  337  altruistic voluntary donation of organs or tissues.
  338         (f)In addition to the general duties described in this
  339  subsection, by September 1, 2021, submit to the agency
  340  recommendations that address all of the following:
  341         1.The frequency of communication between patients and
  342  organ transplant coordinators.
  343         2.The monitoring of each organ transplantation facility
  344  and the annual reporting and publication of relevant information
  345  regarding the statewide number of patients placed on waiting
  346  lists and the number of patients who receive transplants,
  347  aggregated by the facility.
  348         3.The establishment of a coordinated communication system
  349  between organ transplantation facilities and living organ donors
  350  for the purpose of minimizing the cost and time required for
  351  duplicative lab tests, including the sharing of lab results
  352  between facilities.
  353         4.The potential incentives for organ transplantation
  354  facilities which may be necessary to increase organ donation in
  355  this state.
  356         5.The evaluation and encouragement of an efficient living
  357  organ donor process.
  358         6.The potential opportunities and incentives for organ
  359  transplantation research.
  360         7.The best practices for organ transplantation facilities
  361  and organ procurement organizations which promote the most
  362  efficient and effective outcomes for patients.
  363         8.The monitoring of organ procurement organizations.
  364         Section 10. Section 765.548, Florida Statutes, is created
  365  to read:
  366         765.548Duties of the agency; organ donation.—
  367         (1)The agency shall do all of the following:
  368         (a)Monitor the operation of each organ transplantation
  369  facility and organ procurement organization located in this
  370  state.
  371         (b)Develop uniform statewide rules regarding organ
  372  donation. The rules must require that each hospital that
  373  performs organ transplants designate at least one employee or
  374  representative of the hospital who is educated on the protocols
  375  of the hospital and federal and state regulations regarding
  376  organ donation, to provide a clear explanation of such subjects
  377  to any patient, or a patient′s representative, who is
  378  considering posthumous or living organ donation. The rules may
  379  also include, but need not be limited to, procedures for
  380  maintaining a coordinated system of communication between organ
  381  transplantation facilities.
  382         (c)Evaluate the current protocols and procedures used by
  383  organ transplantation facilities and make recommendations for
  384  improving such protocols and procedures.
  385         (d)Establish annual reporting requirements for organ
  386  transplantation facilities and organ procurement organizations.
  387         (e)In consultation with the State Board of Education and
  388  the contractor procured by the agency pursuant to s. 765.5155,
  389  develop a curriculum for educating high school students
  390  regarding the laws of this state relating to organ donation.
  391         (2)By December 1, 2021, and each year thereafter, the
  392  agency shall publish any data and other relevant information to
  393  adequately inform patients and potential donors about organ
  394  donation and organ transplantation.
  395         Section 11. Paragraph (e) of subsection (2) of section
  396  409.815, Florida Statutes, is amended to read:
  397         409.815 Health benefits coverage; limitations.—
  398         (2) BENCHMARK BENEFITS.—In order for health benefits
  399  coverage to qualify for premium assistance payments for an
  400  eligible child under ss. 409.810-409.821, the health benefits
  401  coverage, except for coverage under Medicaid and Medikids, must
  402  include the following minimum benefits, as medically necessary.
  403         (e) Organ transplantation services.—Covered services
  404  include pretransplant, transplant, and postdischarge services
  405  and treatment of complications after transplantation for
  406  transplants deemed necessary and appropriate within the
  407  guidelines set by the Organ Transplant Technical Advisory
  408  Council under s. 765.53 or the Bone Marrow Transplant Advisory
  409  Panel under s. 627.4236.
  410         Section 12. This act shall take effect July 1, 2020.