Florida Senate - 2020 CS for CS for SB 1516 By the Committees on Judiciary; and Health Policy; and Senator Harrell 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. 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 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.) 146 765.53 Organ 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: 320 765.548 Duties 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.