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. 44 45 Be It Enacted by the Legislature of the State of Florida: 46 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,
shallremain in effect and 51 are shall beenforceable 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.)... 100 101 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. 105 106 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 thelaws of120 this staterelating 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.) 143 765.53 Organ 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: 314 765.548 Duties 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.