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. 55 56 Be It Enacted by the Legislature of the State of Florida: 57 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
is69 guilty ofa 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. 99 100 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.)... 141 142 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. 146 147 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 thelaws of161 this staterelating 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: 182 765.5175 Rights 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.) 191 765.53 Organ 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: 366 765.548 Duties 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.