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 department’s 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 program’s 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:
92 381.815 Sickle-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 patient’s 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 patient’s 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 newborn’s 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 organization’s 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:
202 381.981 Health 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:
214 383.14 Screening 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 state’s 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:
250 409.9129 Quality 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 program’s 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:
366 456.0315 Requirement 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:
412 627.64055 Coverage for fertility preservation services.—
413 (1) As used in this section, the term:
414 (a) “Fertility preservation” means the process by which a
415 person’s 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 insured’s 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:
434 627.65741 Coverage for fertility preservation services.—
435 (1) As used in this section, the term:
436 (a) “Fertility preservation” means the process by which a
437 person’s 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 insured’s 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:
456 641.31078 Coverage for fertility preservation services.—
457 (1) As used in this section, the term:
458 (a) “Fertility preservation” means the process by which a
459 person’s 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 subscriber’s 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.