Florida Senate - 2022 SB 1652 By Senator Gibson 6-01205-22 20221652__ 1 A bill to be entitled 2 An act relating to sickle-cell disease; amending s. 3 381.815, F.S.; defining terms; requiring the 4 Department of Health to establish and maintain a 5 sickle-cell registry for a specified purpose; 6 requiring certain providers to report specified 7 information to the registry; requiring the department 8 to use the reported information for specified 9 purposes; requiring the department to analyze the 10 reported information and make certain determinations; 11 requiring the department to publish quarterly reports; 12 providing requirements for the reports; providing 13 duties for the department to promote early detection 14 and treatment of sickle-cell disease; requiring the 15 department to make grants or enter into contracts with 16 certain community-based organizations for the 17 provision of specified services; authorizing the 18 department to adopt rules; amending s. 381.981, F.S.; 19 requiring the department to include sickle-cell 20 disease in its monthly health awareness campaigns; 21 amending s. 383.14, F.S.; requiring the department to 22 adopt rules requiring screening of newborns for 23 sickle-cell disease and sickle-cell trait; requiring 24 any positive test results to be reported to the 25 departments sickle-cell registry; requiring parents 26 of newborns who test positive to be provided with 27 information on further testing and treatment, as 28 applicable; creating s. 409.9129, F.S.; requiring the 29 Agency for Health Care Administration to require 30 managed care organizations to implement a certain 31 quality strategy for a specified purpose; providing 32 requirements for the strategy; requiring managed care 33 organizations to provide certain quarterly reports to 34 the agency; requiring the agency to coordinate with 35 managed care organizations to identify, document, and 36 share certain best practices and to develop a certain 37 plan; requiring the agency to establish performance 38 measures for managed care organizations; requiring the 39 agency to partner with a publicly funded university to 40 develop an assessment tool for screening enrollees 41 with sickle-cell disease for factors relevant to their 42 care; requiring the agency to incorporate certain 43 standard in its contracts with managed care 44 organizations; requiring the agency to conduct an 45 annual review of the Medicaid programs coverage of 46 medications, treatments, and services related to 47 sickle-cell disease; providing requirements for the 48 review; requiring the agency to submit a report of its 49 findings and recommendations to the Governor and the 50 Legislature by a specified date and annually 51 thereafter; requiring the agency to publish the report 52 on its website; requiring the agency to conduct a 53 study of innovative approaches for reimbursement for, 54 coverage of, and access to sickle-cell disease 55 therapies; providing requirements for the study; 56 requiring the agency to hold public meetings with 57 relevant stakeholders; requiring the agency to hold 58 its first meeting by a specified date; requiring the 59 agency to prepare a report of its recommendations by a 60 specified date; requiring the agency to submit the 61 report to the Governor and the Legislature and publish 62 it on its website; providing for expiration; creating 63 s. 456.0315, F.S.; requiring certain boards to require 64 their licensees and certificateholders to complete a 65 continuing education course on sickle-cell disease as 66 part of every second biennial license or certification 67 renewal; providing requirements for the course; 68 providing for submission of proof of completion of 69 such course; authorizing the boards to approve 70 additional equivalent courses; authorizing the boards 71 to include such course within already required 72 continuing education hours under certain 73 circumstances; providing an accommodation for 74 individuals who are dually licensed with regard to 75 such courses; providing for discipline; authorizing 76 the boards to adopt rules; creating ss. 627.64055, 77 627.65741, and 641.31078, F.S.; defining the terms 78 fertility preservation and iatrogenic fertility; 79 requiring certain individual and group health insurers 80 and health maintenance organizations, respectively, to 81 provide coverage for certain fertility preservation 82 services in connection with medically necessary 83 treatments for sickle-cell disease; prohibiting such 84 insurers and organizations from discriminating in 85 their coverage of such services on the basis of 86 specified factors; providing an effective date. 87 88 Be It Enacted by the Legislature of the State of Florida: 89 90 Section 1.Section 381.815, Florida Statutes, is amended to 91 read: 92 381.815Sickle-cell program. 93 (1)DEFINITIONS.As used in this section, the term: 94 (a)Community-based organization means an organization in 95 which survivors of sickle-cell disease hold significant 96 decisionmaking responsibilities and which offers evidence-based 97 sickle-cell disease education and support services at no cost to 98 the public. 99 (b)Department means the Department of Health. 100 (c)Health care provider means a health care practitioner 101 as defined in s. 456.001 or a health care facility or other 102 entity licensed or certified to provide health services in this 103 state. 104 (2)SICKLE-CELL REGISTRY.The department shall establish 105 and maintain a registry for reporting information on the 106 incidence of sickle-cell disease and its variants in this state 107 and other information for epidemiological surveys and 108 evaluations of treatments. 109 (a)Health care providers who diagnose or treat patients 110 with sickle-cell disease shall report the following information 111 for each such patient to the department for inclusion in the 112 registry: 113 1.The patients name, address, age, and ethnicity. 114 2.The variant of sickle-cell disease affecting the 115 patient. 116 3.The method of treatment used by the provider. 117 4.Any other diseases the patient may have. 118 5.The extent to which the patient uses or has access to 119 health care services, if known. 120 6.If the patient dies, the patients age at the time of 121 death. 122 (b)1.Health care providers who conduct newborn screenings 123 for sickle-cell disease and the sickle-cell trait shall report 124 any positive test results to the department for inclusion in the 125 registry in a form and manner prescribed by the department. 126 2.The department shall develop a notification system that 127 informs parents of newborns entered in the registry under 128 subparagraph 1. of the importance of consulting a physician 129 following a diagnosis of the sickle-cell trait or sickle-cell 130 disease. The department must send such notification immediately 131 following the newborns registration in the registry and at 132 least once in early childhood and again in later adolescence. 133 (c)When an individual registered in the registry reaches 134 18 years of age, the department shall make reasonable efforts to 135 notify the individual of his or her inclusion in the registry 136 and of the availability of educational services, genetic 137 counseling, and other benefits and resources. 138 (d)The department shall use information reported to the 139 registry to assess trends, advance research and education, and 140 facilitate the improvement of sickle-cell disease treatment in 141 this state. The department shall analyze the data for trends of 142 low usage of or poor access to health care services in 143 particular geographical areas or demographic groups and conduct 144 further investigation to determine whether improvements can be 145 made to facilitate greater access to sickle-cell disease 146 treatment. 147 (e)The department shall publish quarterly reports based on 148 information collected in the registry. The reports must include 149 all of the following information: 150 1.Aggregate data for the general population and for 151 individuals 60 years of age or older which shows the 152 geographical areas, demographics, and health services 153 utilization of individuals with sickle-cell disease or its 154 variants. 155 2.Data on the transition of adolescents with sickle-cell 156 disease from pediatric care to adult care. 157 (3)PUBLIC OUTREACH AND SERVICES.To promote early 158 detection and treatment of sickle-cell disease, the department 159 of Health shall do all of the following, to the extent that 160 resources are available: 161 (a)(1)Provide statewide education and outreach to inform 162 the public the citizens of Florida about sickle-cell disease, 163 including, but not limited to, available evidence-based sickle 164 cell screening, detection, and education services. 165 (b)Develop or approve education and training on sickle 166 cell disease for health care providers. Such education and 167 training must include, at a minimum, coverage of all of the 168 following: 169 1.The importance of early detection of sickle-cell 170 disease. 171 2.Medically appropriate clinical examinations and 172 screening procedures, including the frequency with which they 173 should be provided. 174 3.Best practices for the detection and treatment of 175 sickle-cell disease and for emergency treatment and management 176 of patients with sickle-cell disease who present with vaso 177 occlusive crises. 178 4.The sickle-cell registry and the reporting requirements 179 established under this section. 180 (c)(2)Work cooperatively with nonprofit organizations not 181 for-profit centers to provide community-based education, patient 182 teaching, and counseling and to encourage diagnostic screening. 183 (d)(3)Make grants or enter into contracts with nonprofit 184 community-based organizations for provision of the following: 185 1.Clinical examinations and screenings for sickle-cell 186 disease. 187 2.Counseling, information on treatment options, and 188 referrals for treatment and services to individuals diagnosed 189 with sickle-cell disease, including information on available 190 economic assistance for treatment. 191 3.Dissemination of information on sickle-cell disease, 192 early detection, and screening to unserved or underserved 193 populations, the general public, and health care practitioners. 194 4.Identification of local sickle-cell disease screening 195 services within the organizations region. 196 5.Any other services that promote early detection and 197 treatment of sickle-cell disease not-for-profit centers. 198 (4)RULES.The department may adopt rules to implement this 199 section. 200 Section 2.Paragraph (v) is added to subsection (2) of 201 section 381.981, Florida Statutes, to read: 202 381.981Health awareness campaigns. 203 (2)The awareness campaigns shall include the provision of 204 educational information about preventing, detecting, treating, 205 and curing the following diseases or conditions. Additional 206 diseases and conditions that impact the public health may be 207 added by the board of directors of the Florida Public Health 208 Institute, Inc.; however, each of the following diseases or 209 conditions must be included in an awareness campaign during at 210 least 1 month in any 24-month period: 211 (v)Sickle-cell disease. 212 Section 3.Paragraph (a) of subsection (2) of section 213 383.14, Florida Statutes, is amended to read: 214 383.14Screening for metabolic disorders, other hereditary 215 and congenital disorders, and environmental risk factors. 216 (2)RULES. 217 (a)After consultation with the Genetics and Newborn 218 Screening Advisory Council, the department shall adopt and 219 enforce rules requiring that every newborn in this state shall: 220 1.Before becoming 1 week of age, be subjected to a test 221 for phenylketonuria; 222 2.Before becoming 1 week of age, be subjected to a test 223 for sickle-cell disease and the sickle-cell trait. If a newborn 224 tests positive for sickle-cell disease or the sickle-cell trait, 225 the result must be reported to the sickle-cell registry in 226 accordance with s. 381.815 and the parents of the newborn must 227 be given information on further testing and treatment, as 228 applicable; 229 3.Be tested for any condition included on the federal 230 Recommended Uniform Screening Panel which the council advises 231 the department should be included under the states screening 232 program. After the council recommends that a condition be 233 included, the department shall submit a legislative budget 234 request to seek an appropriation to add testing of the condition 235 to the newborn screening program. The department shall expand 236 statewide screening of newborns to include screening for such 237 conditions within 18 months after the council renders such 238 advice, if a test approved by the United States Food and Drug 239 Administration or a test offered by an alternative vendor is 240 available. If such a test is not available within 18 months 241 after the council makes its recommendation, the department shall 242 implement such screening as soon as a test offered by the United 243 States Food and Drug Administration or by an alternative vendor 244 is available; and 245 4.3.At the appropriate age, be tested for such other 246 metabolic diseases and hereditary or congenital disorders as the 247 department may deem necessary from time to time. 248 Section 4.Section 409.9129, Florida Statutes, is created 249 to read: 250 409.9129Quality assurance in coverage for enrollees with 251 sickle-cell disease. 252 (1)QUALITY STRATEGY.To ensure the availability of 253 accessible, quality health care for enrollees with sickle-cell 254 disease, the agency must require managed care organizations to 255 implement a quality strategy, which must provide for, at a 256 minimum, all of the following: 257 (a)Improvements in identifying individuals with sickle 258 cell disease. 259 (b)An adequate provider network capacity to ensure timely 260 access to specialty providers for sickle-cell disease treatment. 261 (c)Care coordination strategies to assist enrollees with 262 sickle-cell disease in accessing specialists and other related 263 care supports. 264 (d)Delivery of evidence-based training on sickle-cell 265 disease to primary care providers. Such training must include, 266 at a minimum, instruction on warning signs for emergencies and 267 complications, evidence-based practices and treatment 268 guidelines, and appropriate referrals to specialty treatment 269 providers. 270 (2)QUARTERLY REPORTS; COORDINATION; PERFORMANCE MEASURES. 271 (a)Managed care organizations shall provide quarterly 272 reports to the agency which include the number of children and 273 adults with sickle-cell disease enrolled in each plan and any 274 other information the agency deems necessary to achieve the 275 purposes of this section. 276 (b)The agency, in coordination with the managed care 277 organizations, shall: 278 1.Identify, document, and share best practices regarding 279 sickle-cell disease care management and coordination with 280 enrolled primary care providers and specialty providers. 281 2.Develop a plan for transitioning adolescent enrollees 282 with sickle-cell disease from pediatric care to adult care, 283 including, but not limited to, assisting enrollees who may age 284 out of the Medicaid program to maintain Medicaid coverage under 285 another eligibility category, if qualified. 286 (c)The agency shall establish performance measures for 287 managed care organizations relating to access to care and 288 available therapies for sickle-cell disease, engagement in 289 treatment, and outcomes for enrollees with sickle-cell disease. 290 The agency may use financial incentives to encourage compliance 291 with the performance measures. 292 (3)ASSESSMENT TOOL.The agency shall partner with a 293 publicly funded university to develop a comprehensive sickle 294 cell disease assessment tool to screen enrollees with sickle 295 cell disease for factors relevant to their care. 296 (4)CONTRACTS.The agency shall incorporate standards for 297 coverage of sickle-cell disease treatment in its contracts with 298 managed care organizations, including financial or 299 administrative penalties for noncompliance and adjustments to 300 contracted plan rates to reflect enhanced care. 301 (5)ANNUAL REVIEW.The agency shall conduct an annual 302 review of the Medicaid programs coverage of medications, 303 treatments, and services for enrollees diagnosed with sickle 304 cell disease. 305 (a)In its review, the agency shall do all of the 306 following: 307 1.Review all covered medications, treatments, and services 308 to determine whether such coverage is adequate for the effective 309 treatment of individuals diagnosed with sickle-cell disease and 310 whether the agency should seek Medicaid coverage for additional 311 medications, treatments, or services. 312 2.Review Medicaid coverage of out-of-state treatment of 313 enrollees with sickle-cell disease, comparing it with coverage 314 for similar in-state treatment, to determine whether the program 315 ensures coverage for an equivalent standard of care for patients 316 who are referred or transferred to an out-of-state provider for 317 treatment. 318 3.Determine the extent to which Medicaid reimburses 319 sickle-cell patients for reasonable interstate travel costs 320 associated with treatment for sickle-cell disease. 321 4.Review Medicaid coverage of treatment for emerging 322 adults with sickle-cell disease as they transition into the 323 adult care setting. 324 5.Determine the extent to which emergency room physicians 325 are adequately trained and prepared to treat and manage patients 326 with sickle-cell disease who present with vaso-occlusive crises. 327 6.Solicit and consider input from the public, including 328 individuals impacted by sickle-cell disease and individuals or 329 groups with knowledge or experience in sickle-cell disease 330 treatment. 331 (b)By January 15, 2023, and by January 15 of each year 332 thereafter, the agency shall submit a report of its findings and 333 recommendations to the Governor, the President of the Senate, 334 and the Speaker of the House of Representatives. The agency 335 shall also publish the report on its website. 336 (6)STUDY OF INNOVATIVE PAYMENT MODELS TO ENHANCE ACCESS TO 337 SICKLE-CELL DISEASE THERAPIES. 338 (a)The agency shall conduct a study of innovative 339 approaches to reimbursement for, coverage of, and access to 340 sickle-cell disease therapies, including, but not limited to, 341 separate payments from inpatient bundling, outcomes-based 342 arrangements, carving out sickle-cell disease treatment costs 343 from managed care, and risk-sharing or reinsurance pools. The 344 study must, at a minimum, assess whether current reimbursement 345 methodologies restrict access to potentially curative one-time 346 sickle-cell disease therapies. 347 (b)The agency shall hold at least two public meetings 348 providing an opportunity for public comments and involving 349 discussions between the agency; health care providers who screen 350 for, diagnose, or treat sickle-cell disease; community-based 351 organizations that serve individuals diagnosed with sickle-cell 352 disease; survivors of sickle-cell disease; and other relevant 353 stakeholders. The agency must hold its first meeting by 354 September 1, 2022. 355 (c)By November 1, 2023, the agency shall prepare a report 356 of its final recommendations for policies to be implemented by 357 the agency to support equitable and appropriate access to 358 innovative sickle-cell disease therapies and recommendations for 359 any legislation required to allow the agency to implement such 360 policies. The agency shall submit its report to the Governor, 361 the President of the Senate, and the Speaker of the House of 362 Representatives and publish the report on its website. 363 (d)This subsection expires on December 1, 2023. 364 Section 5.Section 456.0315, Florida Statutes, is created 365 to read: 366 456.0315Requirement for instruction on sickle-cell 367 disease. 368 (1)(a)The appropriate board shall require each person 369 licensed under chapter 458, chapter 459, part I of chapter 464, 370 or chapter 467 to complete, as part of every second biennial 371 license or certification renewal, a 1-hour continuing education 372 course, approved by the board, on sickle-cell disease. The 373 course must cover at least all of the following: 374 1.The importance of early detection of sickle-cell 375 disease. 376 2.Medically appropriate clinical examinations and 377 screening procedures, including the frequency with which they 378 should be provided. 379 3.Best practices for the detection and treatment of 380 sickle-cell disease and for emergency treatment and management 381 of patients with sickle-cell disease who present with vaso 382 occlusive crises. 383 4.The sickle-cell registry and related reporting 384 requirements established under s. 381.815. 385 (b)Each licensee or certificateholder must submit 386 confirmation of having completed the course on a form provided 387 by the board when submitting fees for every second biennial 388 license or certification renewal. 389 (c)The board may approve additional equivalent courses 390 that may be used to satisfy the requirements of paragraph (a), 391 including the education and training developed or approved by 392 the department under s. 381.815(3)(b). Each licensing board that 393 requires a licensee to complete an educational course pursuant 394 to this subsection may include the hour required for completion 395 of the course in the total hours of continuing education 396 required by law for such profession unless the continuing 397 education requirements for such profession consist of fewer than 398 30 hours biennially. 399 (2)Any person holding two or more licenses or 400 certifications subject to this section may show proof of having 401 taken one board-approved course on sickle-cell disease, for 402 purposes of renewing such additional licenses or certifications. 403 (3)Failure to comply with this section constitutes grounds 404 for disciplinary action under the chapters specified in 405 paragraph (1)(a) and s. 456.072(1)(k). In addition to any 406 discipline imposed by the board, the licensee also must be 407 required to complete the required course. 408 (4)Each applicable board may adopt rules to implement this 409 section. 410 Section 6.Section 627.64055, Florida Statutes, is created 411 to read: 412 627.64055Coverage for fertility preservation services. 413 (1)As used in this section, the term: 414 (a)Fertility preservation means the process by which a 415 persons eggs, sperm, or reproductive tissue is saved or 416 protected for future attempts at conception. 417 (b)Iatrogenic infertility means an impairment of 418 fertility which is caused by a medical treatment that affects 419 reproductive organs or processes. 420 (2)A health insurance policy issued, delivered, or renewed 421 in this state on or after July 1, 2022, which provides coverage 422 for medically necessary treatments for sickle-cell disease must 423 also provide coverage for fertility preservation services, 424 including storage costs, if a medically necessary treatment for 425 sickle-cell disease may directly or indirectly cause iatrogenic 426 infertility of the insured. 427 (3)In its coverage of fertility preservation services 428 under this section, an insurer may not discriminate on the basis 429 of the insureds life expectancy, disability, degree of medical 430 dependency, quality of life, or other health conditions or 431 personal characteristics. 432 Section 7.Section 627.65741, Florida Statutes, is created 433 to read: 434 627.65741Coverage for fertility preservation services. 435 (1)As used in this section, the term: 436 (a)Fertility preservation means the process by which a 437 persons eggs, sperm, or reproductive tissue is saved or 438 protected for future attempts at conception. 439 (b)Iatrogenic infertility means an impairment of 440 fertility which is caused by a medical treatment that affects 441 reproductive organs or processes. 442 (2)A group health insurance policy issued, delivered, or 443 renewed in this state on or after July 1, 2022, which provides 444 coverage for medically necessary treatments for sickle-cell 445 disease must also provide coverage for fertility preservation 446 services, including storage costs, if a medically necessary 447 treatment for sickle-cell disease may directly or indirectly 448 cause iatrogenic infertility of the insured. 449 (3)In its coverage of fertility preservation services 450 under this section, an insurer may not discriminate on the basis 451 of the insureds life expectancy, disability, degree of medical 452 dependency, quality of life, or other health conditions or 453 personal characteristics. 454 Section 8.Section 641.31078, Florida Statutes, is created 455 to read: 456 641.31078Coverage for fertility preservation services. 457 (1)As used in this section, the term: 458 (a)Fertility preservation means the process by which a 459 persons eggs, sperm, or reproductive tissue is saved or 460 protected for future attempts at conception. 461 (b)Iatrogenic infertility means an impairment of 462 fertility which is caused by a medical treatment that affects 463 reproductive organs or processes. 464 (2)A health maintenance contract issued or renewed in this 465 state on or after July 1, 2022, which provides coverage for 466 medically necessary treatments for sickle-cell disease must also 467 provide coverage for fertility preservation services, including 468 storage costs, if a medically necessary treatment for sickle 469 cell disease may directly or indirectly cause iatrogenic 470 infertility of the subscriber. 471 (3)In its coverage of fertility preservation services 472 under this section, a health maintenance organization may not 473 discriminate on the basis of the subscribers life expectancy, 474 disability, degree of medical dependency, quality of life, or 475 other health conditions or personal characteristics. 476 Section 9.This act shall take effect July 1, 2022.