Florida Senate - 2019 SENATOR AMENDMENT
Bill No. CS for HB 21
Ì485034ÊÎ485034
LEGISLATIVE ACTION
Senate . House
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Floor: 1/AD/2R . Floor: C
04/26/2019 12:46 PM . 04/29/2019 05:27 PM
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Senator Harrell moved the following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Subsection (10) of section 395.0191, Florida
6 Statutes, is amended to read:
7 395.0191 Staff membership and clinical privileges.—
8 (10) Nothing herein shall be construed by the agency as
9 requiring an applicant for a certificate of need to establish
10 proof of discrimination in the granting of or denial of hospital
11 staff membership or clinical privileges as a precondition to
12 obtaining such certificate of need under the provisions of s.
13 408.043.
14 Section 2. Present subsection (12) of section 395.1055,
15 Florida Statutes, is redesignated as subsection (15), a new
16 subsection (12) and subsections (13) and (14) are added to that
17 section, and paragraph (b) of subsection (9) of that section is
18 amended, to read:
19 395.1055 Rules and enforcement.—
20 (9) The agency shall establish a technical advisory panel,
21 pursuant to s. 20.052, to develop procedures and standards for
22 measuring outcomes of pediatric cardiac catheterization programs
23 and pediatric cardiovascular surgery programs.
24 (b) Voting members of the panel shall include: 3 at-large
25 members, including 1 cardiologist who is board certified in
26 caring for adults with congenital heart disease and 2 board
27 certified pediatric cardiologists, neither of whom may be
28 employed by any of the hospitals specified in subparagraphs 1.
29 10. or their affiliates, each of whom is appointed by the
30 Secretary of Health Care Administration, and 10 members, and an
31 alternate for each member, each of whom is a pediatric
32 cardiologist or a pediatric cardiovascular surgeon, each
33 appointed by the chief executive officer of the following
34 hospitals:
35 1. Johns Hopkins All Children’s Hospital in St. Petersburg.
36 2. Arnold Palmer Hospital for Children in Orlando.
37 3. Joe DiMaggio Children’s Hospital in Hollywood.
38 4. Nicklaus Children’s Hospital in Miami.
39 5. St. Joseph’s Children’s Hospital in Tampa.
40 6. University of Florida Health Shands Hospital in
41 Gainesville.
42 7. University of Miami Holtz Children’s Hospital in Miami.
43 8. Wolfson Children’s Hospital in Jacksonville.
44 9. Florida Hospital for Children in Orlando.
45 10. Nemours Children’s Hospital in Orlando.
46
47 Appointments made under subparagraphs 1.-10. are contingent upon
48 the hospital’s maintenance of pediatric certificates of need and
49 the hospital’s compliance with this section and rules adopted
50 thereunder, as determined by the Secretary of Health Care
51 Administration. A member appointed under subparagraphs 1.-10.
52 whose hospital fails to maintain such certificates or comply
53 with such standards may serve only as a nonvoting member until
54 the hospital restores such certificates or complies with such
55 standards.
56 (12) Each provider of diagnostic cardiac catheterization
57 services shall comply with rules adopted by the agency which
58 establish licensure standards governing the operation of adult
59 inpatient diagnostic cardiac catheterization programs. The rules
60 must ensure that such programs:
61 (a) Comply with the most recent guidelines of the American
62 College of Cardiology and American Heart Association Guidelines
63 for Cardiac Catheterization and Cardiac Catheterization
64 Laboratories.
65 (b) Perform only adult inpatient diagnostic cardiac
66 catheterization services and will not provide therapeutic
67 cardiac catheterization or any other cardiology services.
68 (c) Maintain sufficient appropriate equipment and health
69 care personnel to ensure quality and safety.
70 (d) Maintain appropriate times of operation and protocols
71 to ensure availability and appropriate referrals in the event of
72 emergencies.
73 (e) Demonstrate a plan to provide services to Medicaid and
74 charity care patients.
75 (13) Each provider of adult cardiovascular services or
76 operator of a burn unit shall comply with rules adopted by the
77 agency which establish licensure standards that govern the
78 provision of adult cardiovascular services or the operation of a
79 burn unit, as applicable. At a minimum, such rules must address
80 staffing, equipment, physical plant, operating protocols, the
81 provision of services to Medicaid and charity care patients,
82 accreditation, licensure periods and fees, and enforcement of
83 minimum standards.
84 (14) In establishing rules for adult cardiovascular
85 services, the agency shall include provisions that allow for:
86 (a) The establishment of two hospital program licensure
87 levels, a Level I program that authorizes the performance of
88 adult percutaneous cardiac intervention without onsite cardiac
89 surgery and a Level II program that authorizes the performance
90 of percutaneous cardiac intervention with onsite cardiac
91 surgery.
92 (b)1. For a hospital seeking a Level I program,
93 demonstration that, for the most recent 12-month period as
94 reported to the agency, the hospital has provided a minimum of
95 300 adult inpatient and outpatient diagnostic cardiac
96 catheterizations or, for the most recent 12-month period, has
97 discharged or transferred at least 300 patients with the
98 principal diagnosis of ischemic heart disease and that it has a
99 formalized, written transfer agreement with a hospital that has
100 a Level II program, including written transport protocols to
101 ensure safe and efficient transfer of a patient within 60
102 minutes.
103 2.a. A hospital located more than 100 road miles from the
104 closest Level II adult cardiovascular services program is not
105 required to meet the diagnostic cardiac catheterization volume
106 and ischemic heart disease diagnosis volume requirements in
107 subparagraph 1. if the hospital demonstrates that it has, for
108 the most recent 12-month period as reported to the agency,
109 provided a minimum of 100 adult inpatient and outpatient
110 diagnostic cardiac catheterizations or that, for the most recent
111 12-month period, it has discharged or transferred at least 300
112 patients with the principal diagnosis of ischemic heart disease.
113 b. A hospital located more than 100 road miles from the
114 closest Level II adult cardiovascular services program does not
115 need to meet the 60-minute transfer time protocol requirement in
116 subparagraph 1. if the hospital demonstrates that it has a
117 formalized, written transfer agreement with a hospital that has
118 a Level II program. The agreement must include written transport
119 protocols to ensure the safe and efficient transfer of a
120 patient, taking into consideration the patient’s clinical and
121 physical characteristics, road and weather conditions, and
122 viability of ground and air ambulance service to transfer the
123 patient.
124 3. At a minimum, the rules for adult cardiovascular
125 services must require nursing and technical staff to have
126 demonstrated experience in handling acutely ill patients
127 requiring intervention, based on the staff member’s previous
128 experience in dedicated cardiac interventional laboratories or
129 surgical centers. If a staff member’s previous experience is in
130 a dedicated cardiac interventional laboratory at a hospital that
131 does not have an approved adult open heart surgery program, the
132 staff member’s previous experience qualifies only if, at the
133 time the staff member acquired his or her experience, the
134 dedicated cardiac interventional laboratory:
135 a. Had an annual volume of 500 or more percutaneous cardiac
136 intervention procedures.
137 b. Achieved a demonstrated success rate of 95 percent or
138 greater for percutaneous cardiac intervention procedures.
139 c. Experienced a complication rate of less than 5 percent
140 for percutaneous cardiac intervention procedures.
141 d. Performed diverse cardiac procedures, including, but not
142 limited to, balloon angioplasty and stenting, rotational
143 atherectomy, cutting balloon atheroma remodeling, and procedures
144 relating to left ventricular support capability.
145 (c) For a hospital seeking a Level II program,
146 demonstration that, for the most recent 12-month period as
147 reported to the agency, the hospital has performed a minimum of
148 1,100 adult inpatient and outpatient cardiac catheterizations,
149 of which at least 400 must be therapeutic catheterizations, or,
150 for the most recent 12-month period, has discharged at least 800
151 patients with the principal diagnosis of ischemic heart disease.
152 (d) Compliance with the most recent guidelines of the
153 American College of Cardiology and the American Heart
154 Association guidelines for staffing, physician training and
155 experience, operating procedures, equipment, physical plant, and
156 patient selection criteria, to ensure patient quality and
157 safety.
158 (e) The establishment of appropriate hours of operation and
159 protocols to ensure availability and timely referral in the
160 event of emergencies.
161 (f) The demonstration of a plan to provide services to
162 Medicaid and charity care patients.
163 Section 3. Effective July 1, 2021, paragraph (f) of
164 subsection (1) of section 395.1055, Florida Statutes, is amended
165 to read:
166 395.1055 Rules and enforcement.—
167 (1) The agency shall adopt rules pursuant to ss. 120.536(1)
168 and 120.54 to implement the provisions of this part, which shall
169 include reasonable and fair minimum standards for ensuring that:
170 (f) All hospitals submit such data as necessary to conduct
171 certificate-of-need reviews required under part I of chapter
172 408. Such data shall include, but shall not be limited to,
173 patient origin data, hospital utilization data, type of service
174 reporting, and facility staffing data. The agency may not
175 collect data that identifies or could disclose the identity of
176 individual patients. The agency shall utilize existing uniform
177 statewide data sources when available and shall minimize
178 reporting costs to hospitals.
179 Section 4. Effective July 1, 2021, subsection (5) of
180 section 395.1065, Florida Statutes, is amended to read:
181 395.1065 Criminal and administrative penalties;
182 moratorium.—
183 (5) The agency shall impose a fine of $500 for each
184 instance of the facility’s failure to provide the information
185 required by rules adopted pursuant to s. 395.1055(1)(g) s.
186 395.1055(1)(h).
187 Section 5. Section 395.6025, Florida Statutes, is repealed.
188 Section 6. Subsections (3), (8), and (13) through (17) of
189 section 408.032, Florida Statutes, are amended to read:
190 408.032 Definitions relating to Health Facility and
191 Services Development Act.—As used in ss. 408.031-408.045, the
192 term:
193 (3) “Certificate of need” means a written statement issued
194 by the agency evidencing community need for a new, converted,
195 expanded, or otherwise significantly modified health care
196 facility, health service, or hospice.
197 (8) “Health care facility” means a hospital, long-term care
198 hospital, skilled nursing facility, hospice, or intermediate
199 care facility for the developmentally disabled. A facility
200 relying solely on spiritual means through prayer for healing is
201 not included as a health care facility.
202 (13) “Long-term care hospital” means a hospital licensed
203 under chapter 395 which meets the requirements of 42 C.F.R. s.
204 412.23(e) and seeks exclusion from the acute care Medicare
205 prospective payment system for inpatient hospital services.
206 (14) “Mental health services” means inpatient services
207 provided in a hospital licensed under chapter 395 and listed on
208 the hospital license as psychiatric beds for adults; psychiatric
209 beds for children and adolescents; intensive residential
210 treatment beds for children and adolescents; substance abuse
211 beds for adults; or substance abuse beds for children and
212 adolescents.
213 (13)(15) “Nursing home geographically underserved area”
214 means:
215 (a) A county in which there is no existing or approved
216 nursing home;
217 (b) An area with a radius of at least 20 miles in which
218 there is no existing or approved nursing home; or
219 (c) An area with a radius of at least 20 miles in which all
220 existing nursing homes have maintained at least a 95 percent
221 occupancy rate for the most recent 6 months or a 90 percent
222 occupancy rate for the most recent 12 months.
223 (14)(16) “Skilled nursing facility” means an institution,
224 or a distinct part of an institution, which is primarily engaged
225 in providing, to inpatients, skilled nursing care and related
226 services for patients who require medical or nursing care, or
227 rehabilitation services for the rehabilitation of injured,
228 disabled, or sick persons.
229 (17) “Tertiary health service” means a health service
230 which, due to its high level of intensity, complexity,
231 specialized or limited applicability, and cost, should be
232 limited to, and concentrated in, a limited number of hospitals
233 to ensure the quality, availability, and cost-effectiveness of
234 such service. Examples of such service include, but are not
235 limited to, pediatric cardiac catheterization, pediatric open
236 heart surgery, organ transplantation, neonatal intensive care
237 units, comprehensive rehabilitation, and medical or surgical
238 services which are experimental or developmental in nature to
239 the extent that the provision of such services is not yet
240 contemplated within the commonly accepted course of diagnosis or
241 treatment for the condition addressed by a given service. The
242 agency shall establish by rule a list of all tertiary health
243 services.
244 Section 7. Effective July 1, 2021, subsection (8), and
245 subsections (9) through (11), as amended by this act, of section
246 408.032, Florida Statutes, are amended to read:
247 408.032 Definitions relating to Health Facility and
248 Services Development Act.—As used in ss. 408.031-408.045, the
249 term:
250 (8) “Health care facility” means a hospital, skilled
251 nursing facility, hospice, or intermediate care facility for the
252 developmentally disabled. A facility relying solely on spiritual
253 means through prayer for healing is not included as a health
254 care facility.
255 (9) “Health services” means inpatient diagnostic, curative,
256 or comprehensive medical rehabilitative services and includes
257 mental health services. Obstetric services are not health
258 services for purposes of ss. 408.031-408.045.
259 (9)(10) “Hospice” or “hospice program” means a hospice as
260 defined in part IV of chapter 400.
261 (11) “Hospital” means a health care facility licensed under
262 chapter 395.
263 (10)(12) “Intermediate care facility for the
264 developmentally disabled” means a residential facility licensed
265 under part VIII of chapter 400.
266 (11)(13) “Nursing home geographically underserved area”
267 means:
268 (a) A county in which there is no existing or approved
269 nursing home;
270 (b) An area with a radius of at least 20 miles in which
271 there is no existing or approved nursing home; or
272 (c) An area with a radius of at least 20 miles in which all
273 existing nursing homes have maintained at least a 95 percent
274 occupancy rate for the most recent 6 months or a 90 percent
275 occupancy rate for the most recent 12 months.
276 (12)(14) “Skilled nursing facility” means an institution,
277 or a distinct part of an institution, which is primarily engaged
278 in providing, to inpatients, skilled nursing care and related
279 services for patients who require medical or nursing care, or
280 rehabilitation services for the rehabilitation of injured,
281 disabled, or sick persons.
282 Section 8. Effective July 1, 2021, paragraph (b) of
283 subsection (1) of section 408.033, Florida Statutes, is amended
284 to read:
285 408.033 Local and state health planning.—
286 (1) LOCAL HEALTH COUNCILS.—
287 (b) Each local health council may:
288 1. Develop a district area health plan that permits each
289 local health council to develop strategies and set priorities
290 for implementation based on its unique local health needs.
291 2. Advise the agency on health care issues and resource
292 allocations.
293 3. Promote public awareness of community health needs,
294 emphasizing health promotion and cost-effective health service
295 selection.
296 4. Collect data and conduct analyses and studies related to
297 health care needs of the district, including the needs of
298 medically indigent persons, and assist the agency and other
299 state agencies in carrying out data collection activities that
300 relate to the functions in this subsection.
301 5. Monitor the onsite construction progress, if any, of
302 certificate-of-need approved projects and report council
303 findings to the agency on forms provided by the agency.
304 6. Advise and assist any regional planning councils within
305 each district that have elected to address health issues in
306 their strategic regional policy plans with the development of
307 the health element of the plans to address the health goals and
308 policies in the State Comprehensive Plan.
309 7. Advise and assist local governments within each district
310 on the development of an optional health plan element of the
311 comprehensive plan provided in chapter 163, to assure
312 compatibility with the health goals and policies in the State
313 Comprehensive Plan and district health plan. To facilitate the
314 implementation of this section, the local health council shall
315 annually provide the local governments in its service area, upon
316 request, with:
317 a. A copy and appropriate updates of the district health
318 plan;
319 b. A report of hospital and nursing home utilization
320 statistics for facilities within the local government
321 jurisdiction; and
322 c. Applicable agency rules and calculated need
323 methodologies for health facilities and services regulated under
324 s. 408.034 for the district served by the local health council.
325 8. Monitor and evaluate the adequacy, appropriateness, and
326 effectiveness, within the district, of local, state, federal,
327 and private funds distributed to meet the needs of the medically
328 indigent and other underserved population groups.
329 9. In conjunction with the Department of Health, plan for
330 services at the local level for persons infected with the human
331 immunodeficiency virus.
332 10. Provide technical assistance to encourage and support
333 activities by providers, purchasers, consumers, and local,
334 regional, and state agencies in meeting the health care goals,
335 objectives, and policies adopted by the local health council.
336 11. Provide the agency with data required by rule for the
337 review of certificate-of-need applications and the projection of
338 need for health services and facilities in the district.
339 Section 9. Subsection (2) of section 408.034, Florida
340 Statutes, is amended to read:
341 408.034 Duties and responsibilities of agency; rules.—
342 (2) In the exercise of its authority to issue licenses to
343 health care facilities and health service providers, as provided
344 under chapters 393 and 395 and parts II, IV, and VIII of chapter
345 400, the agency may not issue a license to any health care
346 facility or health service provider that fails to receive a
347 certificate of need or an exemption for the licensed facility,
348 except that the agency may issue a license to a general hospital
349 that has not been issued a certificate of need or service.
350 Section 10. Effective July 1, 2021, subsection (2), as
351 amended by this act, and subsection (3) of section 408.034,
352 Florida Statutes, are amended to read:
353 408.034 Duties and responsibilities of agency; rules.—
354 (2) In the exercise of its authority to issue licenses to
355 health care facilities, as provided under chapter chapters 393
356 and 395 and parts II, IV, and VIII of chapter 400, the agency
357 may not issue a license to any health care facility that fails
358 to receive a certificate of need or an exemption for the
359 licensed facility, except that the agency may issue a license to
360 a general hospital that has not been issued a certificate of
361 need.
362 (3) The agency shall establish, by rule, uniform need
363 methodologies for health services and health facilities. In
364 developing uniform need methodologies, the agency shall, at a
365 minimum, consider the demographic characteristics of the
366 population, the health status of the population, service use
367 patterns, standards and trends, geographic accessibility, and
368 market economics.
369 Section 11. Section 408.035, Florida Statutes, is amended
370 to read:
371 408.035 Review criteria.—
372 (1) The agency shall determine the reviewability of
373 applications and shall review applications for certificate-of
374 need determinations for health care facilities and health
375 services in context with the following criteria, except for
376 general hospitals as defined in s. 395.002:
377 (1)(a) The need for the health care facilities and health
378 services being proposed.
379 (2)(b) The availability, quality of care, accessibility,
380 and extent of utilization of existing health care facilities and
381 health services in the service district of the applicant.
382 (3)(c) The ability of the applicant to provide quality of
383 care and the applicant’s record of providing quality of care.
384 (4)(d) The availability of resources, including health
385 personnel, management personnel, and funds for capital and
386 operating expenditures, for project accomplishment and
387 operation.
388 (5)(e) The extent to which the proposed services will
389 enhance access to health care for residents of the service
390 district.
391 (6)(f) The immediate and long-term financial feasibility of
392 the proposal.
393 (7)(g) The extent to which the proposal will foster
394 competition that promotes quality and cost-effectiveness.
395 (8)(h) The costs and methods of the proposed construction,
396 including the costs and methods of energy provision and the
397 availability of alternative, less costly, or more effective
398 methods of construction.
399 (9)(i) The applicant’s past and proposed provision of
400 health care services to Medicaid patients and the medically
401 indigent.
402 (10)(j) The applicant’s designation as a Gold Seal Program
403 nursing facility pursuant to s. 400.235, when the applicant is
404 requesting additional nursing home beds at that facility.
405 (2) For a general hospital, the agency shall consider only
406 the criteria specified in paragraph (1)(a), paragraph (1)(b),
407 except for quality of care in paragraph (1)(b), and paragraphs
408 (1)(e), (g), and (i).
409 Section 12. Effective July 1, 2021, subsection (2) of
410 section 408.035, Florida Statutes, as amended by this act, is
411 amended to read:
412 408.035 Review criteria.—The agency shall determine the
413 reviewability of applications and shall review applications for
414 certificate-of-need determinations for health care facilities in
415 context with the following criteria:
416 (2) The availability, quality of care, accessibility, and
417 extent of utilization of existing health care facilities and
418 health services in the service district of the applicant.
419 Section 13. Subsection (1) and paragraphs (i) through (q)
420 of subsection (3) of section 408.036, Florida Statutes, are
421 amended to read:
422 408.036 Projects subject to review; exemptions.—
423 (1) APPLICABILITY.—Unless exempt under subsection (3), all
424 health-care-related projects, as described in this subsection
425 paragraphs (a)-(f), are subject to review and must file an
426 application for a certificate of need with the agency. The
427 agency is exclusively responsible for determining whether a
428 health-care-related project is subject to review under ss.
429 408.031-408.045.
430 (a) The addition of beds in community nursing homes or
431 intermediate care facilities for the developmentally disabled by
432 new construction or alteration.
433 (b) The new construction or establishment of additional
434 health care facilities, except for the construction of or
435 establishment of a general hospital or including a replacement
436 health care facility when the proposed project site is not
437 located on the same site as or within 1 mile of the existing
438 health care facility, if the number of beds in each licensed bed
439 category will not increase.
440 (c) The conversion from one type of health care facility to
441 another, including the conversion from a general hospital or, a
442 specialty hospital, except that the conversion of a specialty
443 hospital to a general hospital is not subject to review or a
444 long-term care hospital.
445 (d) The establishment of a hospice or hospice inpatient
446 facility, except as provided in s. 408.043.
447 (e) An increase in the number of beds for comprehensive
448 rehabilitation.
449 (f) The establishment of tertiary health services,
450 including inpatient comprehensive rehabilitation services.
451 (3) EXEMPTIONS.—Upon request, the following projects are
452 subject to exemption from the provisions of subsection (1):
453 (i) For the addition of hospital beds licensed under
454 chapter 395 for comprehensive rehabilitation in a number that
455 may not exceed 10 total beds or 10 percent of the licensed
456 capacity, whichever is greater.
457 1. In addition to any other documentation otherwise
458 required by the agency, a request for exemption submitted under
459 this paragraph must:
460 a. Certify that the prior 12-month average occupancy rate
461 for the licensed beds being expanded meets or exceeds 80
462 percent.
463 b. Certify that the beds have been licensed and operational
464 for at least 12 months.
465 2. The timeframes and monitoring process specified in s.
466 408.040(2)(a)-(c) apply to any exemption issued under this
467 paragraph.
468 3. The agency shall count beds authorized under this
469 paragraph as approved beds in the published inventory of
470 hospital beds until the beds are licensed.
471 (i)(j) For the addition of nursing home beds licensed under
472 chapter 400 in a number not exceeding 10 total beds or 10
473 percent of the number of beds licensed in the facility being
474 expanded, whichever is greater; or, for the addition of nursing
475 home beds licensed under chapter 400 at a facility that has been
476 designated as a Gold Seal nursing home under s. 400.235 in a
477 number not exceeding 20 total beds or 10 percent of the number
478 of licensed beds in the facility being expanded, whichever is
479 greater.
480 1. In addition to any other documentation required by the
481 agency, a request for exemption submitted under this paragraph
482 must certify that:
483 a. The facility has not had any class I or class II
484 deficiencies within the 30 months preceding the request.
485 b. The prior 12-month average occupancy rate for the
486 nursing home beds at the facility meets or exceeds 94 percent.
487 c. Any beds authorized for the facility under this
488 paragraph before the date of the current request for an
489 exemption have been licensed and operational for at least 12
490 months.
491 2. The timeframes and monitoring process specified in s.
492 408.040(2)(a)-(c) apply to any exemption issued under this
493 paragraph.
494 3. The agency shall count beds authorized under this
495 paragraph as approved beds in the published inventory of nursing
496 home beds until the beds are licensed.
497 (k) For the establishment of:
498 1. A Level II neonatal intensive care unit with at least 10
499 beds, upon documentation to the agency that the applicant
500 hospital had a minimum of 1,500 births during the previous 12
501 months;
502 2. A Level III neonatal intensive care unit with at least
503 15 beds, upon documentation to the agency that the applicant
504 hospital has a Level II neonatal intensive care unit of at least
505 10 beds and had a minimum of 3,500 births during the previous 12
506 months; or
507 3. A Level III neonatal intensive care unit with at least 5
508 beds, upon documentation to the agency that the applicant
509 hospital is a verified trauma center pursuant to s.
510 395.4001(15), and has a Level II neonatal intensive care unit,
511
512 if the applicant demonstrates that it meets the requirements for
513 quality of care, nurse staffing, physician staffing, physical
514 plant, equipment, emergency transportation, and data reporting
515 found in agency certificate-of-need rules for Level II and Level
516 III neonatal intensive care units and if the applicant commits
517 to the provision of services to Medicaid and charity patients at
518 a level equal to or greater than the district average. Such a
519 commitment is subject to s. 408.040.
520 (l) For the addition of mental health services or beds if
521 the applicant commits to providing services to Medicaid or
522 charity care patients at a level equal to or greater than the
523 district average. Such a commitment is subject to s. 408.040.
524 (j)(m) For replacement of a licensed nursing home on the
525 same site, or within 5 miles of the same site if within the same
526 subdistrict, if the number of licensed beds does not increase
527 except as permitted under paragraph (e).
528 (k)(n) For consolidation or combination of licensed nursing
529 homes or transfer of beds between licensed nursing homes within
530 the same planning district, by nursing homes with any shared
531 controlled interest within that planning district, if there is
532 no increase in the planning district total number of nursing
533 home beds and the site of the relocation is not more than 30
534 miles from the original location.
535 (l)(o) For beds in state mental health treatment facilities
536 defined in s. 394.455 and state mental health forensic
537 facilities operated under chapter 916.
538 (m)(p) For beds in state developmental disabilities centers
539 as defined in s. 393.063.
540 (n)(q) For the establishment of a health care facility or
541 project that meets all of the following criteria:
542 1. The applicant was previously licensed within the past 21
543 days as a health care facility or provider that is subject to
544 subsection (1).
545 2. The applicant failed to submit a renewal application and
546 the license expired on or after January 1, 2015.
547 3. The applicant does not have a license denial or
548 revocation action pending with the agency at the time of the
549 request.
550 4. The applicant’s request is for the same service type,
551 district, service area, and site for which the applicant was
552 previously licensed.
553 5. The applicant’s request, if applicable, includes the
554 same number and type of beds as were previously licensed.
555 6. The applicant agrees to the same conditions that were
556 previously imposed on the certificate of need or on an exemption
557 related to the applicant’s previously licensed health care
558 facility or project.
559 7. The applicant applies for initial licensure as required
560 under s. 408.806 within 21 days after the agency approves the
561 exemption request. If the applicant fails to apply in a timely
562 manner, the exemption expires on the 22nd day following the
563 agency’s approval of the exemption.
564
565 Notwithstanding subparagraph 1., an applicant whose license
566 expired between January 1, 2015, and the effective date of this
567 act may apply for an exemption within 30 days of this act
568 becoming law.
569 Section 14. Effective July 1, 2021, paragraphs (b), (c),
570 (l), (m), and (n) of subsection (1), as amended by this act, and
571 subsections (2) and (5) of section 408.036, Florida Statutes,
572 are amended to read:
573 408.036 Projects subject to review; exemptions.—
574 (1) APPLICABILITY.—Unless exempt under subsection (3), all
575 health-care-related projects, as described in this subsection,
576 are subject to review and must file an application for a
577 certificate of need with the agency. The agency is exclusively
578 responsible for determining whether a health-care-related
579 project is subject to review under ss. 408.031-408.045.
580 (b) The new construction or establishment of additional
581 health care facilities, except for the construction of or
582 establishment of a general hospital or a replacement health care
583 facility when the proposed project site is located on the same
584 site as or within 1 mile of the existing health care facility if
585 the number of beds in each licensed bed category will not
586 increase.
587 (c) The conversion from one type of health care facility to
588 another, including the conversion from a general hospital or a
589 specialty hospital, except that the conversion of a specialty
590 hospital to a general hospital is not subject to review.
591 (l) For beds in state mental health treatment facilities
592 defined in s. 394.455 and state mental health forensic
593 facilities operated under chapter 916.
594 (l)(m) For beds in state developmental disabilities centers
595 as defined in s. 393.063.
596 (m)(n) For the establishment of a health care facility or
597 project that meets all of the following criteria:
598 1. The applicant was previously licensed within the past 21
599 days as a health care facility or provider that is subject to
600 subsection (1).
601 2. The applicant failed to submit a renewal application and
602 the license expired on or after January 1, 2015.
603 3. The applicant does not have a license denial or
604 revocation action pending with the agency at the time of the
605 request.
606 4. The applicant’s request is for the same service type,
607 district, service area, and site for which the applicant was
608 previously licensed.
609 5. The applicant’s request, if applicable, includes the
610 same number and type of beds as were previously licensed.
611 6. The applicant agrees to the same conditions that were
612 previously imposed on the certificate of need or on an exemption
613 related to the applicant’s previously licensed health care
614 facility or project.
615 7. The applicant applies for initial licensure as required
616 under s. 408.806 within 21 days after the agency approves the
617 exemption request. If the applicant fails to apply in a timely
618 manner, the exemption expires on the 22nd day following the
619 agency’s approval of the exemption.
620 (2) PROJECTS SUBJECT TO EXPEDITED REVIEW.—Unless exempt
621 pursuant to subsection (3), the following projects are subject
622 to expedited review:
623 (a) Transfer of a certificate of need, except that when an
624 existing hospital is acquired by a purchaser, all certificates
625 of need issued to the hospital which are not yet operational
626 shall be acquired by the purchaser without need for a transfer.
627 (5) NOTIFICATION.—Health care facilities and providers must
628 provide to the agency notification of:
629 (a) replacement of a health care facility when the proposed
630 project site is located in the same district and on the existing
631 site or within a 1-mile radius of the replaced health care
632 facility, if the number and type of beds do not increase.
633 (b) The termination of a health care service, upon 30 days’
634 written notice to the agency.
635 (c) The addition or delicensure of beds. Notification under
636 this subsection may be made by electronic, facsimile, or written
637 means at any time before the described action has been taken.
638 Section 15. Section 408.0361, Florida Statutes, is
639 repealed.
640 Section 16. Section 408.037, Florida Statutes, is amended
641 to read:
642 408.037 Application content.—
643 (1) Except as provided in subsection (2) for a general
644 hospital, An application for a certificate of need must contain:
645 (a) A detailed description of the proposed project and
646 statement of its purpose and need in relation to the district
647 health plan.
648 (b) A statement of the financial resources needed by and
649 available to the applicant to accomplish the proposed project.
650 This statement must include:
651 1. A complete listing of all capital projects, including
652 new health facility development projects and health facility
653 acquisitions applied for, pending, approved, or underway in any
654 state at the time of application, regardless of whether or not
655 that state has a certificate-of-need program or a capital
656 expenditure review program pursuant to s. 1122 of the Social
657 Security Act. The agency may, by rule, require less-detailed
658 information from major health care providers. This listing must
659 include the applicant’s actual or proposed financial commitment
660 to those projects and an assessment of their impact on the
661 applicant’s ability to provide the proposed project.
662 2. A detailed listing of the needed capital expenditures,
663 including sources of funds.
664 3. A detailed financial projection, including a statement
665 of the projected revenue and expenses for the first 2 years of
666 operation after completion of the proposed project. This
667 statement must include a detailed evaluation of the impact of
668 the proposed project on the cost of other services provided by
669 the applicant.
670 (c) An audited financial statement of the applicant or the
671 applicant’s parent corporation if audited financial statements
672 of the applicant do not exist. In an application submitted by an
673 existing health care facility, health maintenance organization,
674 or hospice, financial condition documentation must include, but
675 need not be limited to, a balance sheet and a profit-and-loss
676 statement of the 2 previous fiscal years’ operation.
677 (2) An application for a certificate of need for a general
678 hospital must contain a detailed description of the proposed
679 general hospital project and a statement of its purpose and the
680 needs it will meet. The proposed project’s location, as well as
681 its primary and secondary service areas, must be identified by
682 zip code. Primary service area is defined as the zip codes from
683 which the applicant projects that it will draw 75 percent of its
684 discharges. Secondary service area is defined as the zip codes
685 from which the applicant projects that it will draw its
686 remaining discharges. If, subsequent to issuance of a final
687 order approving the certificate of need, the proposed location
688 of the general hospital changes or the primary service area
689 materially changes, the agency shall revoke the certificate of
690 need. However, if the agency determines that such changes are
691 deemed to enhance access to hospital services in the service
692 district, the agency may permit such changes to occur. A party
693 participating in the administrative hearing regarding the
694 issuance of the certificate of need for a general hospital has
695 standing to participate in any subsequent proceeding regarding
696 the revocation of the certificate of need for a hospital for
697 which the location has changed or for which the primary service
698 area has materially changed. In addition, the application for
699 the certificate of need for a general hospital must include a
700 statement of intent that, if approved by final order of the
701 agency, the applicant shall within 120 days after issuance of
702 the final order or, if there is an appeal of the final order,
703 within 120 days after the issuance of the court’s mandate on
704 appeal, furnish satisfactory proof of the applicant’s financial
705 ability to operate. The agency shall establish documentation
706 requirements, to be completed by each applicant, which show
707 anticipated provider revenues and expenditures, the basis for
708 financing the anticipated cash-flow requirements of the
709 provider, and an applicant’s access to contingency financing. A
710 party participating in the administrative hearing regarding the
711 issuance of the certificate of need for a general hospital may
712 provide written comments concerning the adequacy of the
713 financial information provided, but such party does not have
714 standing to participate in an administrative proceeding
715 regarding proof of the applicant’s financial ability to operate.
716 The agency may require a licensee to provide proof of financial
717 ability to operate at any time if there is evidence of financial
718 instability, including, but not limited to, unpaid expenses
719 necessary for the basic operations of the provider.
720 (2)(3) The applicant must certify that it will license and
721 operate the health care facility. For an existing health care
722 facility, the applicant must be the licenseholder of the
723 facility.
724 Section 17. Paragraphs (c) and (d) of subsection (3),
725 paragraphs (b) and (c) of subsection (5), and paragraph (d) of
726 subsection (6) of section 408.039, Florida Statutes, are amended
727 to read:
728 408.039 Review process.—The review process for certificates
729 of need shall be as follows:
730 (3) APPLICATION PROCESSING.—
731 (c) Except for competing applicants, in order to be
732 eligible to challenge the agency decision on a general hospital
733 application under review pursuant to paragraph (5)(c), existing
734 hospitals must submit a detailed written statement of opposition
735 to the agency and to the applicant. The detailed written
736 statement must be received by the agency and the applicant
737 within 21 days after the general hospital application is deemed
738 complete and made available to the public.
739 (d) In those cases where a written statement of opposition
740 has been timely filed regarding a certificate of need
741 application for a general hospital, the applicant for the
742 general hospital may submit a written response to the agency.
743 Such response must be received by the agency within 10 days of
744 the written statement due date.
745 (5) ADMINISTRATIVE HEARINGS.—
746 (b) Hearings shall be held in Tallahassee unless the
747 administrative law judge determines that changing the location
748 will facilitate the proceedings. The agency shall assign
749 proceedings requiring hearings to the Division of Administrative
750 Hearings of the Department of Management Services within 10 days
751 after the time has expired for requesting a hearing. Except upon
752 unanimous consent of the parties or upon the granting by the
753 administrative law judge of a motion of continuance, hearings
754 shall commence within 60 days after the administrative law judge
755 has been assigned. For an application for a general hospital,
756 administrative hearings shall commence within 6 months after the
757 administrative law judge has been assigned, and a continuance
758 may not be granted absent a finding of extraordinary
759 circumstances by the administrative law judge. All parties,
760 except the agency, shall bear their own expense of preparing a
761 transcript. In any application for a certificate of need which
762 is referred to the Division of Administrative Hearings for
763 hearing, the administrative law judge shall complete and submit
764 to the parties a recommended order as provided in ss. 120.569
765 and 120.57. The recommended order shall be issued within 30 days
766 after the receipt of the proposed recommended orders or the
767 deadline for submission of such proposed recommended orders,
768 whichever is earlier. The division shall adopt procedures for
769 administrative hearings which shall maximize the use of
770 stipulated facts and shall provide for the admission of prepared
771 testimony.
772 (c) In administrative proceedings challenging the issuance
773 or denial of a certificate of need, only applicants considered
774 by the agency in the same batching cycle are entitled to a
775 comparative hearing on their applications. Existing health care
776 facilities may initiate or intervene in an administrative
777 hearing upon a showing that an established program will be
778 substantially affected by the issuance of any certificate of
779 need, whether reviewed under s. 408.036(1) or (2), to a
780 competing proposed facility or program within the same district.
781 With respect to an application for a general hospital, competing
782 applicants and only those existing hospitals that submitted a
783 detailed written statement of opposition to an application as
784 provided in this paragraph may initiate or intervene in an
785 administrative hearing. Such challenges to a general hospital
786 application shall be limited in scope to the issues raised in
787 the detailed written statement of opposition that was provided
788 to the agency. The administrative law judge may, upon a motion
789 showing good cause, expand the scope of the issues to be heard
790 at the hearing. Such motion shall include substantial and
791 detailed facts and reasons for failure to include such issues in
792 the original written statement of opposition.
793 (6) JUDICIAL REVIEW.—
794 (d) The party appealing a final order that grants a general
795 hospital certificate of need shall pay the appellee’s attorney’s
796 fees and costs, in an amount up to $1 million, from the
797 beginning of the original administrative action if the appealing
798 party loses the appeal, subject to the following limitations and
799 requirements:
800 1. The party appealing a final order must post a bond in
801 the amount of $1 million in order to maintain the appeal.
802 2. Except as provided under s. 120.595(5), in no event
803 shall the agency be held liable for any other party’s attorney’s
804 fees or costs.
805 Section 18. Subsection (1) of section 408.043, Florida
806 Statutes, is amended to read:
807 408.043 Special provisions.—
808 (1) OSTEOPATHIC ACUTE CARE HOSPITALS.—When an application
809 is made for a certificate of need to construct or to expand an
810 osteopathic acute care hospital, the need for such hospital
811 shall be determined on the basis of the need for and
812 availability of osteopathic services and osteopathic acute care
813 hospitals in the district. When a prior certificate of need to
814 establish an osteopathic acute care hospital has been issued in
815 a district, and the facility is no longer used for that purpose,
816 the agency may continue to count such facility and beds as an
817 existing osteopathic facility in any subsequent application for
818 construction of an osteopathic acute care hospital.
819 Section 19. Section 408.0455, Florida Statutes, is amended
820 to read:
821 408.0455 Rules; pending proceedings.—The rules of the
822 agency in effect on June 30, 2004, shall remain in effect and
823 shall be enforceable by the agency with respect to ss. 408.031
824 408.045 until such rules are repealed or amended by the agency.
825 Rules 59C-1.039 through 59C-1.044, F.A.C., remain in effect for
826 the sole purpose of maintaining licensure requirements for the
827 applicable services until the agency has adopted rules for the
828 corresponding services pursuant to s. 395.1055(1)(i), Florida
829 Statutes 2018.
830 Section 20. Subsection (3) of section 408.808, Florida
831 Statutes, is amended to read:
832 408.808 License categories.—
833 (3) INACTIVE LICENSE.—An inactive license may be issued to
834 a hospital or a health care provider subject to the certificate
835 of-need provisions in part I of this chapter when the provider
836 is currently licensed, does not have a provisional license, and
837 will be temporarily unable to provide services but is reasonably
838 expected to resume services within 12 months. Such designation
839 may be made for a period not to exceed 12 months but may be
840 renewed by the agency for up to 12 additional months upon
841 demonstration by the licensee of the provider’s progress toward
842 reopening. However, if after 20 months in an inactive license
843 status, a statutory rural hospital, as defined in s. 395.602,
844 has demonstrated progress toward reopening, but may not be able
845 to reopen prior to the inactive license expiration date, the
846 inactive designation may be renewed again by the agency for up
847 to 12 additional months. For purposes of such a second renewal,
848 if construction or renovation is required, the licensee must
849 have had plans approved by the agency and construction must have
850 already commenced pursuant to s. 408.032(4); however, if
851 construction or renovation is not required, the licensee must
852 provide proof of having made an enforceable capital expenditure
853 greater than 25 percent of the total costs associated with the
854 hiring of staff and the purchase of equipment and supplies
855 needed to operate the facility upon opening. A request by a
856 licensee for an inactive license or to extend the previously
857 approved inactive period must be submitted to the agency and
858 must include a written justification for the inactive license
859 with the beginning and ending dates of inactivity specified, a
860 plan for the transfer of any clients to other providers, and the
861 appropriate licensure fees. The agency may not accept a request
862 that is submitted after initiating closure, after any suspension
863 of service, or after notifying clients of closure or suspension
864 of service, unless the action is a result of a disaster at the
865 licensed premises. For the purposes of this section, the term
866 “disaster” means a sudden emergency occurrence beyond the
867 control of the licensee, whether natural, technological, or
868 manmade, which renders the provider inoperable at the premises.
869 Upon agency approval, the provider shall notify clients of any
870 necessary discharge or transfer as required by authorizing
871 statutes or applicable rules. The beginning of the inactive
872 license period is the date the provider ceases operations. The
873 end of the inactive license period shall become the license
874 expiration date. All licensure fees must be current, must be
875 paid in full, and may be prorated. Reactivation of an inactive
876 license requires the approval of a renewal application,
877 including payment of licensure fees and agency inspections
878 indicating compliance with all requirements of this part,
879 authorizing statutes, and applicable rules.
880 Section 21. The Office of Program Policy Analysis and
881 Government Accountability shall review federal requirements and
882 other states’ licensure statutes and rules governing the
883 provision of tertiary health services as defined in s. 408.032,
884 Florida Statutes 2018, and shall make recommendations to the
885 President of the Senate and the Speaker of the House of
886 Representatives on best practices, including recommendations on
887 minimum volume requirements, as applicable, regarding the
888 establishment of licensure standards for such programs by
889 November 1, 2019.
890 Section 22. Except as otherwise expressly provided in this
891 act, this act shall take effect July 1, 2019.
892
893 ================= T I T L E A M E N D M E N T ================
894 And the title is amended as follows:
895 Delete everything before the enacting clause
896 and insert:
897 A bill to be entitled
898 An act relating to hospital licensure; amending s.
899 395.0191, F.S.; deleting provisions relating to
900 certificate of need applications; amending s.
901 395.1055, F.S.; revising the Agency for Health Care
902 Administration’s rulemaking authority with respect to
903 minimum standards for hospitals; requiring hospitals
904 that provide certain services to meet specified
905 licensure requirements; conforming provisions to
906 changes made by the act; amending s. 395.1065, F.S.;
907 conforming a cross-reference; repealing s. 395.6025,
908 F.S., relating to rural hospital replacement
909 facilities; amending s. 408.032, F.S.; revising and
910 deleting definitions; amending s. 408.033, F.S.;
911 conforming provisions to changes made by the act;
912 amending s. 408.034, F.S.; authorizing the agency to
913 issue a license to a general hospital that has not
914 been issued a certificate of need under certain
915 circumstances; revising duties and responsibilities of
916 the agency relating to issuance of licenses to health
917 care facilities and health service providers;
918 conforming provisions to changes made by the act;
919 amending s. 408.035, F.S.; deleting provisions related
920 to the agency’s consideration and review of
921 applications for certificates of need for general
922 hospitals and health services; amending s. 408.036,
923 F.S.; providing an exception to certificate of need
924 review requirements for the construction or
925 establishment of a general hospital and the conversion
926 of a specialty hospital to a general hospital;
927 revising health-care-related projects that are subject
928 to agency review for a certificate of need and
929 exemptions therefrom; deleting provisions requiring
930 health care facilities and providers to provide
931 certain notice to the agency upon termination of a
932 health care service or the addition or delicensure of
933 beds; conforming a provision to changes made by the
934 act; repealing s. 408.0361, F.S., relating to
935 cardiovascular services and burn unit licensure;
936 amending ss. 408.037 and 408.039, F.S.; deleting
937 provisions relating to certificate of need
938 applications for general hospitals; amending s.
939 408.043, F.S.; deleting provisions relating to
940 certificates of need for osteopathic acute care
941 hospitals; amending s. 408.0455, F.S.; establishing
942 that specified rules remain in effect for a specified
943 purpose and until the agency has adopted certain
944 rules; amending s. 408.808, F.S.; authorizing the
945 agency to issue an inactive license to a certain
946 hospital under certain circumstances; requiring the
947 Office of Program Policy Analysis and Government
948 Accountability to review specified requirements,
949 statutes, and rules, and make recommendations to the
950 Legislature by a specified date; providing effective
951 dates.