Florida Senate - 2020 COMMITTEE AMENDMENT Bill No. SB 1516 Ì705054ÇÎ705054 LEGISLATIVE ACTION Senate . House . . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— The Committee on Health Policy (Harrell) recommended the following: 1 Senate Amendment (with title amendment) 2 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,
shallremain in effect and 9 are shall beenforceable by the agency with respect to ss. 10 408.031-408.045 until such rules are repealed or amended by the 11 agency.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.)... 58 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. 63 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 thelaws of78 this staterelating 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.) 113 765.53 Organ 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: 282 765.548 Duties 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. 320 321 ================= 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.