Bill Text: FL S1492 | 2018 | Regular Session | Introduced
Bill Title: Certificates of Need for Hospitals
Spectrum: Partisan Bill (Republican 2-0)
Status: (Failed) 2018-03-10 - Died in Health Policy [S1492 Detail]
Download: Florida-2018-S1492-Introduced.html
Florida Senate - 2018 SB 1492
By Senator Brandes
24-01427-18 20181492__
1 A bill to be entitled
2 An act relating to certificates of need for hospitals;
3 amending s. 408.032, F.S.; revising and deleting
4 definitions; amending s. 408.034, F.S.; revising
5 duties and responsibilities of the Agency for Health
6 Care Administration relating to issuance of licenses
7 to health care facilities and health service
8 providers; conforming provisions to changes made by
9 the act; amending s. 408.035, F.S.; excluding general
10 hospitals from certain agency review of applications
11 for certificate-of-need determinations; amending s.
12 408.036, F.S.; revising health-care-related projects
13 subject to agency review for a certificate of need and
14 exemptions therefrom; deleting provisions requiring
15 health care facilities and providers to provide
16 certain notice to the agency upon termination of a
17 health care service or the addition or delicensure of
18 beds; conforming a provision; amending ss. 408.037 and
19 408.039, F.S.; conforming provisions to changes made
20 by the act; amending s. 408.043, F.S.; deleting
21 certificate-of-need requirements for osteopathic acute
22 care hospitals; amending s. 395.1055, F.S.; revising
23 the agency’s rulemaking authority with respect to
24 minimum standards for hospitals; requiring hospitals
25 that provide certain services to meet specified
26 licensure requirements; conforming provisions to
27 changes made by the act; repealing s. 395.6025, F.S.,
28 relating to rural hospital replacement facilities;
29 amending ss. 395.603, 395.605, and 408.033, F.S.;
30 conforming provisions to changes made by the act;
31 amending s. 395.604, F.S.; conforming a cross
32 reference; amending s. 408.0361, F.S.; deleting
33 obsolete provisions; providing an effective date.
34
35 Be It Enacted by the Legislature of the State of Florida:
36
37 Section 1. Subsections (8) through (17) of section 408.032,
38 Florida Statutes, are amended to read:
39 408.032 Definitions relating to Health Facility and
40 Services Development Act.—As used in ss. 408.031-408.045, the
41 term:
42 (8) “Health care facility” means a hospital, long-term care
43 hospital, skilled nursing facility, hospice, or intermediate
44 care facility for the developmentally disabled. A facility
45 relying solely on spiritual means through prayer for healing is
46 not included as a health care facility.
47 (9) “Health services” means inpatient diagnostic, curative,
48 or comprehensive medical rehabilitative services and includes
49 mental health services. Obstetric services are not health
50 services for purposes of ss. 408.031-408.045.
51 (9)(10) “Hospice” or “hospice program” means a hospice as
52 defined in part IV of chapter 400.
53 (11) “Hospital” means a health care facility licensed under
54 chapter 395.
55 (10)(12) “Intermediate care facility for the
56 developmentally disabled” means a residential facility licensed
57 under part VIII of chapter 400.
58 (13) “Long-term care hospital” means a hospital licensed
59 under chapter 395 which meets the requirements of 42 C.F.R. s.
60 412.23(e) and seeks exclusion from the acute care Medicare
61 prospective payment system for inpatient hospital services.
62 (14) “Mental health services” means inpatient services
63 provided in a hospital licensed under chapter 395 and listed on
64 the hospital license as psychiatric beds for adults; psychiatric
65 beds for children and adolescents; intensive residential
66 treatment beds for children and adolescents; substance abuse
67 beds for adults; or substance abuse beds for children and
68 adolescents.
69 (11)(15) “Nursing home geographically underserved area”
70 means:
71 (a) A county in which there is no existing or approved
72 nursing home;
73 (b) An area with a radius of at least 20 miles in which
74 there is no existing or approved nursing home; or
75 (c) An area with a radius of at least 20 miles in which all
76 existing nursing homes have maintained at least a 95 percent
77 occupancy rate for the most recent 6 months or a 90 percent
78 occupancy rate for the most recent 12 months.
79 (12)(16) “Skilled nursing facility” means an institution,
80 or a distinct part of an institution, which is primarily engaged
81 in providing, to inpatients, skilled nursing care and related
82 services for patients who require medical or nursing care, or
83 rehabilitation services for the rehabilitation of injured,
84 disabled, or sick persons.
85 (17) “Tertiary health service” means a health service
86 which, due to its high level of intensity, complexity,
87 specialized or limited applicability, and cost, should be
88 limited to, and concentrated in, a limited number of hospitals
89 to ensure the quality, availability, and cost-effectiveness of
90 such service. Examples of such service include, but are not
91 limited to, pediatric cardiac catheterization, pediatric open
92 heart surgery, organ transplantation, neonatal intensive care
93 units, comprehensive rehabilitation, and medical or surgical
94 services which are experimental or developmental in nature to
95 the extent that the provision of such services is not yet
96 contemplated within the commonly accepted course of diagnosis or
97 treatment for the condition addressed by a given service. The
98 agency shall establish by rule a list of all tertiary health
99 services.
100 Section 2. Subsections (2) and (3) of section 408.034,
101 Florida Statutes, are amended to read:
102 408.034 Duties and responsibilities of agency; rules.—
103 (2) In the exercise of its authority to issue licenses to
104 health care facilities and health service providers, as provided
105 under chapter chapters 393 and 395 and parts II, IV, and VIII of
106 chapter 400, the agency may not issue a license to any health
107 care facility or health service provider that fails to receive a
108 certificate of need or an exemption for the licensed facility or
109 service.
110 (3) The agency shall establish, by rule, uniform need
111 methodologies for health services and health facilities. In
112 developing uniform need methodologies, the agency shall, at a
113 minimum, consider the demographic characteristics of the
114 population, the health status of the population, service use
115 patterns, standards and trends, geographic accessibility, and
116 market economics.
117 Section 3. Section 408.035, Florida Statutes, is amended to
118 read:
119 408.035 Review criteria.—
120 (1) The agency shall determine the reviewability of
121 applications and shall review applications for certificate-of
122 need determinations for health care facilities and health
123 services in context with the following criteria, except for
124 general hospitals as defined in s. 395.002:
125 (1)(a) The need for the health care facilities and health
126 services being proposed.
127 (2)(b) The availability, quality of care, accessibility,
128 and extent of utilization of existing health care facilities and
129 health services in the service district of the applicant.
130 (3)(c) The ability of the applicant to provide quality of
131 care and the applicant’s record of providing quality of care.
132 (4)(d) The availability of resources, including health
133 personnel, management personnel, and funds for capital and
134 operating expenditures, for project accomplishment and
135 operation.
136 (5)(e) The extent to which the proposed services will
137 enhance access to health care for residents of the service
138 district.
139 (6)(f) The immediate and long-term financial feasibility of
140 the proposal.
141 (7)(g) The extent to which the proposal will foster
142 competition that promotes quality and cost-effectiveness.
143 (8)(h) The costs and methods of the proposed construction,
144 including the costs and methods of energy provision and the
145 availability of alternative, less costly, or more effective
146 methods of construction.
147 (9)(i) The applicant’s past and proposed provision of
148 health care services to Medicaid patients and the medically
149 indigent.
150 (10)(j) The applicant’s designation as a Gold Seal Program
151 nursing facility pursuant to s. 400.235, when the applicant is
152 requesting additional nursing home beds at that facility.
153 (2) For a general hospital, the agency shall consider only
154 the criteria specified in paragraph (1)(a), paragraph (1)(b),
155 except for quality of care in paragraph (1)(b), and paragraphs
156 (1)(e), (g), and (i).
157 Section 4. Section 408.036, Florida Statutes, is amended to
158 read:
159 408.036 Projects subject to review; exemptions.—
160 (1) APPLICABILITY.—Unless exempt under subsection (3), all
161 health-care-related projects, as described in this subsection
162 paragraphs (a)-(f), are subject to review and must file an
163 application for a certificate of need with the agency. The
164 agency is exclusively responsible for determining whether a
165 health-care-related project is subject to review under ss.
166 408.031-408.045.
167 (a) The addition of beds in community nursing homes or
168 intermediate care facilities for the developmentally disabled by
169 new construction or alteration.
170 (b) The new construction or establishment of additional
171 health care facilities, including a replacement health care
172 facility when the proposed project site is not located on the
173 same site as or within 1 mile of the existing health care
174 facility, if the number of beds in each licensed bed category
175 will not increase.
176 (c) The conversion from one type of health care facility to
177 another, including the conversion from a general hospital, a
178 specialty hospital, or a long-term care hospital.
179 (d) The establishment of a hospice or hospice inpatient
180 facility, except as provided in s. 408.043.
181 (e) An increase in the number of beds for comprehensive
182 rehabilitation.
183 (f) The establishment of tertiary health services,
184 including inpatient comprehensive rehabilitation services.
185 (2) PROJECTS SUBJECT TO EXPEDITED REVIEW.—Unless exempt
186 pursuant to subsection (3), the following projects are subject
187 to expedited review:
188 (a) Transfer of a certificate of need, except that when an
189 existing hospital is acquired by a purchaser, all certificates
190 of need issued to the hospital which are not yet operational
191 shall be acquired by the purchaser without need for a transfer.
192 (b) Replacement of a nursing home, if the proposed project
193 site is within a 30-mile radius of the replaced nursing home. If
194 the proposed project site is outside the subdistrict where the
195 replaced nursing home is located, the prior 6-month occupancy
196 rate for licensed community nursing homes in the proposed
197 subdistrict must be at least 85 percent in accordance with the
198 agency’s most recently published inventory.
199 (c) Replacement of a nursing home within the same district,
200 if the proposed project site is outside a 30-mile radius of the
201 replaced nursing home but within the same subdistrict or a
202 geographically contiguous subdistrict. If the proposed project
203 site is in the geographically contiguous subdistrict, the prior
204 6-month occupancy rate for licensed community nursing homes for
205 that subdistrict must be at least 85 percent in accordance with
206 the agency’s most recently published inventory.
207 (d) Relocation of a portion of a nursing home’s licensed
208 beds to another facility or to establish a new facility within
209 the same district or within a geographically contiguous
210 district, if the relocation is within a 30-mile radius of the
211 existing facility and the total number of nursing home beds in
212 the state does not increase.
213 (e) New construction of a community nursing home in a
214 retirement community as further provided in this paragraph.
215 1. Expedited review under this paragraph is available if
216 all of the following criteria are met:
217 a. The residential use area of the retirement community is
218 deed-restricted as housing for older persons as defined in s.
219 760.29(4)(b).
220 b. The retirement community is located in a county in which
221 25 percent or more of its population is age 65 and older.
222 c. The retirement community is located in a county that has
223 a rate of no more than 16.1 beds per 1,000 persons age 65 years
224 or older. The rate shall be determined by using the current
225 number of licensed and approved community nursing home beds in
226 the county per the agency’s most recent published inventory.
227 d. The retirement community has a population of at least
228 8,000 residents within the county, based on a population data
229 source accepted by the agency.
230 e. The number of proposed community nursing home beds in an
231 application does not exceed the projected bed need after
232 applying the rate of 16.1 beds per 1,000 persons aged 65 years
233 and older projected for the county 3 years into the future using
234 the estimates adopted by the agency reduced by the agency’s most
235 recently published inventory of licensed and approved community
236 nursing home beds in the county.
237 2. No more than 120 community nursing home beds shall be
238 approved for a qualified retirement community under each request
239 for expedited review. Subsequent requests for expedited review
240 under this process may not be made until 2 years after
241 construction of the facility has commenced or 1 year after the
242 beds approved through the initial request are licensed,
243 whichever occurs first.
244 3. The total number of community nursing home beds which
245 may be approved for any single deed-restricted community
246 pursuant to this paragraph may not exceed 240, regardless of
247 whether the retirement community is located in more than one
248 qualifying county.
249 4. Each nursing home facility approved under this paragraph
250 must be dually certified for participation in the Medicare and
251 Medicaid programs.
252 5. Each nursing home facility approved under this paragraph
253 must be at least 1 mile, as measured over publicly owned
254 roadways, from an existing approved and licensed community
255 nursing home.
256 6. A retirement community requesting expedited review under
257 this paragraph shall submit a written request to the agency for
258 expedited review. The request must include the number of beds to
259 be added and provide evidence of compliance with the criteria
260 specified in subparagraph 1.
261 7. After verifying that the retirement community meets the
262 criteria for expedited review specified in subparagraph 1., the
263 agency shall publicly notice in the Florida Administrative
264 Register that a request for an expedited review has been
265 submitted by a qualifying retirement community and that the
266 qualifying retirement community intends to make land available
267 for the construction and operation of a community nursing home.
268 The agency’s notice must identify where potential applicants can
269 obtain information describing the sales price of, or terms of
270 the land lease for, the property on which the project will be
271 located and the requirements established by the retirement
272 community. The agency notice must also specify the deadline for
273 submission of the certificate-of-need application, which may not
274 be earlier than the 91st day or later than the 125th day after
275 the date the notice appears in the Florida Administrative
276 Register.
277 8. The qualified retirement community shall make land
278 available to applicants it deems to have met its requirements
279 for the construction and operation of a community nursing home
280 but may sell or lease the land only to the applicant that is
281 issued a certificate of need by the agency under this paragraph.
282 a. A certificate-of-need application submitted under this
283 paragraph must identify the intended site for the project within
284 the retirement community and the anticipated costs for the
285 project based on that site. The application must also include
286 written evidence that the retirement community has determined
287 that both the provider submitting the application and the
288 project satisfy its requirements for the project.
289 b. If the retirement community determines that more than
290 one provider satisfies its requirements for the project, it may
291 notify the agency of the provider it prefers.
292 9. The agency shall review each submitted application. If
293 multiple applications are submitted for a project published
294 pursuant to subparagraph 7., the agency shall review the
295 competing applications.
296
297 The agency shall develop rules to implement the expedited review
298 process, including time schedule, application content that may
299 be reduced from the full requirements of s. 408.037(1), and
300 application processing.
301 (3) EXEMPTIONS.—Upon request, the following projects are
302 subject to exemption from the provisions of subsection (1):
303 (a) For hospice services or for swing beds in a rural
304 hospital, as defined in s. 395.602, in a number that does not
305 exceed one-half of its licensed beds, or for a hospice program
306 established by an entity that shares a controlling interest, as
307 defined in s. 408.803, with a not-for-profit retirement
308 community that offers independent living, assisted living, and
309 skilled nursing services provided in a facility on the same
310 premises and designated by the agency as a teaching nursing home
311 for a minimum of 5 years, in accordance with s. 430.80. Only one
312 hospice program per teaching nursing home may be established
313 under the exemption in this paragraph, and such program shall be
314 limited to serving patients residing in communities located
315 within the not-for-profit retirement community, including home
316 and community-based service providers.
317 (b) For the conversion of licensed acute care hospital beds
318 to Medicare and Medicaid certified skilled nursing beds in a
319 rural hospital, as defined in s. 395.602, so long as the
320 conversion of the beds does not involve the construction of new
321 facilities. The total number of skilled nursing beds, including
322 swing beds, may not exceed one-half of the total number of
323 licensed beds in the rural hospital as of July 1, 1993.
324 Certified skilled nursing beds designated under this paragraph,
325 excluding swing beds, shall be included in the community nursing
326 home bed inventory. A rural hospital that subsequently
327 decertifies any acute care beds exempted under this paragraph
328 shall notify the agency of the decertification, and the agency
329 shall adjust the community nursing home bed inventory
330 accordingly.
331 (b)(c) For the addition of nursing home beds at a skilled
332 nursing facility that is part of a retirement community that
333 provides a variety of residential settings and supportive
334 services and that has been incorporated and operated in this
335 state for at least 65 years on or before July 1, 1994. All
336 nursing home beds must not be available to the public but must
337 be for the exclusive use of the community residents.
338 (c)(d) For an inmate health care facility built by or for
339 the exclusive use of the Department of Corrections as provided
340 in chapter 945. This exemption expires when such facility is
341 converted to other uses.
342 (d)(e) For mobile surgical facilities and related health
343 care services provided under contract with the Department of
344 Corrections or a private correctional facility operating
345 pursuant to chapter 957.
346 (e)(f) For the addition of nursing home beds licensed under
347 chapter 400 in a number not exceeding 30 total beds or 25
348 percent of the number of beds licensed in the facility being
349 replaced under paragraph (2)(b), paragraph (2)(c), or paragraph
350 (j) (p), whichever is less.
351 (f)(g) For state veterans’ nursing homes operated by or on
352 behalf of the Florida Department of Veterans’ Affairs in
353 accordance with part II of chapter 296 for which at least 50
354 percent of the construction cost is federally funded and for
355 which the Federal Government pays a per diem rate not to exceed
356 one-half of the cost of the veterans’ care in such state nursing
357 homes. These beds shall not be included in the nursing home bed
358 inventory.
359 (g)(h) For combination within one nursing home facility of
360 the beds or services authorized by two or more certificates of
361 need issued in the same planning subdistrict. An exemption
362 granted under this paragraph shall extend the validity period of
363 the certificates of need to be consolidated by the length of the
364 period beginning upon submission of the exemption request and
365 ending with issuance of the exemption. The longest validity
366 period among the certificates shall be applicable to each of the
367 combined certificates.
368 (h)(i) For division into two or more nursing home
369 facilities of beds or services authorized by one certificate of
370 need issued in the same planning subdistrict. An exemption
371 granted under this paragraph shall extend the validity period of
372 the certificate of need to be divided by the length of the
373 period beginning upon submission of the exemption request and
374 ending with issuance of the exemption.
375 (j) For the addition of hospital beds licensed under
376 chapter 395 for comprehensive rehabilitation in a number that
377 may not exceed 10 total beds or 10 percent of the licensed
378 capacity, whichever is greater.
379 1. In addition to any other documentation otherwise
380 required by the agency, a request for exemption submitted under
381 this paragraph must:
382 a. Certify that the prior 12-month average occupancy rate
383 for the licensed beds being expanded meets or exceeds 80
384 percent.
385 b. Certify that the beds have been licensed and operational
386 for at least 12 months.
387 2. The timeframes and monitoring process specified in s.
388 408.040(2)(a)-(c) apply to any exemption issued under this
389 paragraph.
390 3. The agency shall count beds authorized under this
391 paragraph as approved beds in the published inventory of
392 hospital beds until the beds are licensed.
393 (i)(k) For the addition of nursing home beds licensed under
394 chapter 400 in a number not exceeding 10 total beds or 10
395 percent of the number of beds licensed in the facility being
396 expanded, whichever is greater; or, for the addition of nursing
397 home beds licensed under chapter 400 at a facility that has been
398 designated as a Gold Seal nursing home under s. 400.235 in a
399 number not exceeding 20 total beds or 10 percent of the number
400 of licensed beds in the facility being expanded, whichever is
401 greater.
402 1. In addition to any other documentation required by the
403 agency, a request for exemption submitted under this paragraph
404 must certify that:
405 a. The facility has not had any class I or class II
406 deficiencies within the 30 months preceding the request.
407 b. The prior 12-month average occupancy rate for the
408 nursing home beds at the facility meets or exceeds 94 percent.
409 c. Any beds authorized for the facility under this
410 paragraph before the date of the current request for an
411 exemption have been licensed and operational for at least 12
412 months.
413 2. The timeframes and monitoring process specified in s.
414 408.040(2)(a)-(c) apply to any exemption issued under this
415 paragraph.
416 3. The agency shall count beds authorized under this
417 paragraph as approved beds in the published inventory of nursing
418 home beds until the beds are licensed.
419 (l) For the establishment of:
420 1. A Level II neonatal intensive care unit with at least 10
421 beds, upon documentation to the agency that the applicant
422 hospital had a minimum of 1,500 births during the previous 12
423 months;
424 2. A Level III neonatal intensive care unit with at least
425 15 beds, upon documentation to the agency that the applicant
426 hospital has a Level II neonatal intensive care unit of at least
427 10 beds and had a minimum of 3,500 births during the previous 12
428 months; or
429 3. A Level III neonatal intensive care unit with at least 5
430 beds, upon documentation to the agency that the applicant
431 hospital is a verified trauma center pursuant to s.
432 395.4001(14), and has a Level II neonatal intensive care unit,
433
434 if the applicant demonstrates that it meets the requirements for
435 quality of care, nurse staffing, physician staffing, physical
436 plant, equipment, emergency transportation, and data reporting
437 found in agency certificate-of-need rules for Level II and Level
438 III neonatal intensive care units and if the applicant commits
439 to the provision of services to Medicaid and charity patients at
440 a level equal to or greater than the district average. Such a
441 commitment is subject to s. 408.040.
442 (m)1. For the provision of adult open-heart services in a
443 hospital located within the boundaries of a health service
444 planning district, as defined in s. 408.032(5), which has
445 experienced an annual net out-migration of at least 600 open
446 heart-surgery cases for 3 consecutive years according to the
447 most recent data reported to the agency, and the district’s
448 population per licensed and operational open-heart programs
449 exceeds the state average of population per licensed and
450 operational open-heart programs by at least 25 percent. All
451 hospitals within a health service planning district which meet
452 the criteria reference in sub-subparagraphs 2.a.-h. shall be
453 eligible for this exemption on July 1, 2004, and shall receive
454 the exemption upon filing for it and subject to the following:
455 a. A hospital that has received a notice of intent to grant
456 a certificate of need or a final order of the agency granting a
457 certificate of need for the establishment of an open-heart
458 surgery program is entitled to receive a letter of exemption for
459 the establishment of an adult open-heart-surgery program upon
460 filing a request for exemption and complying with the criteria
461 enumerated in sub-subparagraphs 2.a.-h., and is entitled to
462 immediately commence operation of the program.
463 b. An otherwise eligible hospital that has not received a
464 notice of intent to grant a certificate of need or a final order
465 of the agency granting a certificate of need for the
466 establishment of an open-heart-surgery program is entitled to
467 immediately receive a letter of exemption for the establishment
468 of an adult open-heart-surgery program upon filing a request for
469 exemption and complying with the criteria enumerated in sub
470 subparagraphs 2.a.-h., but is not entitled to commence operation
471 of its program until December 31, 2006.
472 2. A hospital shall be exempt from the certificate-of-need
473 review for the establishment of an open-heart-surgery program
474 when the application for exemption submitted under this
475 paragraph complies with the following criteria:
476 a. The applicant must certify that it will meet and
477 continuously maintain the minimum licensure requirements adopted
478 by the agency governing adult open-heart programs, including the
479 most current guidelines of the American College of Cardiology
480 and American Heart Association Guidelines for Adult Open Heart
481 Programs.
482 b. The applicant must certify that it will maintain
483 sufficient appropriate equipment and health personnel to ensure
484 quality and safety.
485 c. The applicant must certify that it will maintain
486 appropriate times of operation and protocols to ensure
487 availability and appropriate referrals in the event of
488 emergencies.
489 d. The applicant can demonstrate that it has discharged at
490 least 300 inpatients with a principal diagnosis of ischemic
491 heart disease for the most recent 12-month period as reported to
492 the agency.
493 e. The applicant is a general acute care hospital that is
494 in operation for 3 years or more.
495 f. The applicant is performing more than 300 diagnostic
496 cardiac catheterization procedures per year, combined inpatient
497 and outpatient.
498 g. The applicant’s payor mix at a minimum reflects the
499 community average for Medicaid, charity care, and self-pay
500 patients or the applicant must certify that it will provide a
501 minimum of 5 percent of Medicaid, charity care, and self-pay to
502 open-heart-surgery patients.
503 h. If the applicant fails to meet the established criteria
504 for open-heart programs or fails to reach 300 surgeries per year
505 by the end of its third year of operation, it must show cause
506 why its exemption should not be revoked.
507 3. By December 31, 2004, and annually thereafter, the
508 agency shall submit a report to the Legislature providing
509 information concerning the number of requests for exemption it
510 has received under this paragraph during the calendar year and
511 the number of exemptions it has granted or denied during the
512 calendar year.
513 (n) For the provision of percutaneous coronary intervention
514 for patients presenting with emergency myocardial infarctions in
515 a hospital without an approved adult open-heart-surgery program.
516 In addition to any other documentation required by the agency, a
517 request for an exemption submitted under this paragraph must
518 comply with the following:
519 1. The applicant must certify that it will meet and
520 continuously maintain the requirements adopted by the agency for
521 the provision of these services. These licensure requirements
522 shall be adopted by rule and must be consistent with the
523 guidelines published by the American College of Cardiology and
524 the American Heart Association for the provision of percutaneous
525 coronary interventions in hospitals without adult open-heart
526 services. At a minimum, the rules must require the following:
527 a. Cardiologists must be experienced interventionalists who
528 have performed a minimum of 75 interventions within the previous
529 12 months.
530 b. The hospital must provide a minimum of 36 emergency
531 interventions annually in order to continue to provide the
532 service.
533 c. The hospital must offer sufficient physician, nursing,
534 and laboratory staff to provide the services 24 hours a day, 7
535 days a week.
536 d. Nursing and technical staff must have demonstrated
537 experience in handling acutely ill patients requiring
538 intervention based on previous experience in dedicated
539 interventional laboratories or surgical centers.
540 e. Cardiac care nursing staff must be adept in hemodynamic
541 monitoring and Intra-aortic Balloon Pump (IABP) management.
542 f. Formalized written transfer agreements must be developed
543 with a hospital with an adult open-heart-surgery program, and
544 written transport protocols must be in place to ensure safe and
545 efficient transfer of a patient within 60 minutes. Transfer and
546 transport agreements must be reviewed and tested, with
547 appropriate documentation maintained at least every 3 months.
548 However, a hospital located more than 100 road miles from the
549 closest Level II adult cardiovascular services program does not
550 need to meet the 60-minute transfer time protocol if the
551 hospital demonstrates that it has a formalized, written transfer
552 agreement with a hospital that has a Level II program. The
553 agreement must include written transport protocols that ensure
554 the safe and efficient transfer of a patient, taking into
555 consideration the patient’s clinical and physical
556 characteristics, road and weather conditions, and viability of
557 ground and air ambulance service to transfer the patient.
558 g. Hospitals implementing the service must first undertake
559 a training program of 3 to 6 months’ duration, which includes
560 establishing standards and testing logistics, creating quality
561 assessment and error management practices, and formalizing
562 patient-selection criteria.
563 2. The applicant must certify that it will use at all times
564 the patient-selection criteria for the performance of primary
565 angioplasty at hospitals without adult open-heart-surgery
566 programs issued by the American College of Cardiology and the
567 American Heart Association. At a minimum, these criteria would
568 provide for the following:
569 a. Avoidance of interventions in hemodynamically stable
570 patients who have identified symptoms or medical histories.
571 b. Transfer of patients who have a history of coronary
572 disease and clinical presentation of hemodynamic instability.
573 3. The applicant must agree to submit a quarterly report to
574 the agency detailing patient characteristics, treatment, and
575 outcomes for all patients receiving emergency percutaneous
576 coronary interventions pursuant to this paragraph. This report
577 must be submitted within 15 days after the close of each
578 calendar quarter.
579 4. The exemption provided by this paragraph does not apply
580 unless the agency determines that the hospital has taken all
581 necessary steps to be in compliance with all requirements of
582 this paragraph, including the training program required under
583 sub-subparagraph 1.g.
584 5. Failure of the hospital to continuously comply with the
585 requirements of sub-subparagraphs 1.c.-f. and subparagraphs 2.
586 and 3. will result in the immediate expiration of this
587 exemption.
588 6. Failure of the hospital to meet the volume requirements
589 of sub-subparagraphs 1.a. and b. within 18 months after the
590 program begins offering the service will result in the immediate
591 expiration of the exemption.
592
593 If the exemption for this service expires under subparagraph 5.
594 or subparagraph 6., the agency may not grant another exemption
595 for this service to the same hospital for 2 years and then only
596 upon a showing that the hospital will remain in compliance with
597 the requirements of this paragraph through a demonstration of
598 corrections to the deficiencies that caused expiration of the
599 exemption. Compliance with the requirements of this paragraph
600 includes compliance with the rules adopted pursuant to this
601 paragraph.
602 (o) For the addition of mental health services or beds if
603 the applicant commits to providing services to Medicaid or
604 charity care patients at a level equal to or greater than the
605 district average. Such a commitment is subject to s. 408.040.
606 (j)(p) For replacement of a licensed nursing home on the
607 same site, or within 5 miles of the same site if within the same
608 subdistrict, if the number of licensed beds does not increase
609 except as permitted under paragraph (e)(f).
610 (k)(q) For consolidation or combination of licensed nursing
611 homes or transfer of beds between licensed nursing homes within
612 the same planning district, by nursing homes with any shared
613 controlled interest within that planning district, if there is
614 no increase in the planning district total number of nursing
615 home beds and the site of the relocation is not more than 30
616 miles from the original location.
617 (l)(r) For beds in state mental health treatment facilities
618 defined in s. 394.455 and state mental health forensic
619 facilities operated under chapter 916.
620 (m)(s) For beds in state developmental disabilities centers
621 as defined in s. 393.063.
622 (n)(t) For the establishment of a health care facility or
623 project that meets all of the following criteria:
624 1. The applicant was previously licensed within the past 21
625 days as a health care facility or provider that is subject to
626 subsection (1).
627 2. The applicant failed to submit a renewal application and
628 the license expired on or after January 1, 2015.
629 3. The applicant does not have a license denial or
630 revocation action pending with the agency at the time of the
631 request.
632 4. The applicant’s request is for the same service type,
633 district, service area, and site for which the applicant was
634 previously licensed.
635 5. The applicant’s request, if applicable, includes the
636 same number and type of beds as were previously licensed.
637 6. The applicant agrees to the same conditions that were
638 previously imposed on the certificate of need or on an exemption
639 related to the applicant’s previously licensed health care
640 facility or project.
641 7. The applicant applies for initial licensure as required
642 under s. 408.806 within 21 days after the agency approves the
643 exemption request. If the applicant fails to apply in a timely
644 manner, the exemption expires on the 22nd day following the
645 agency’s approval of the exemption.
646
647 Notwithstanding subparagraph 1., an applicant whose license
648 expired between January 1, 2015, and the effective date of this
649 act may apply for an exemption within 30 days of this act
650 becoming law.
651 (4) REQUESTS FOR EXEMPTION.—A request for exemption under
652 subsection (3) may be made at any time and is not subject to the
653 batching requirements of this section. The request shall be
654 supported by such documentation as the agency requires by rule.
655 The agency shall assess a fee of $250 for each request for
656 exemption submitted under subsection (3).
657 (5) NOTIFICATION.—Health care facilities and providers must
658 provide to the agency notification of:
659 (a) replacement of a health care facility when the proposed
660 project site is located in the same district and on the existing
661 site or within a 1-mile radius of the replaced health care
662 facility, if the number and type of beds do not increase.
663 (b) The termination of a health care service, upon 30 days’
664 written notice to the agency.
665 (c) The addition or delicensure of beds.
666
667 Notification under this subsection may be made by electronic,
668 facsimile, or written means at any time before the described
669 action has been taken.
670 Section 5. Section 408.037, Florida Statutes, is amended to
671 read:
672 408.037 Application content.—
673 (1) Except as provided in subsection (2) for a general
674 hospital, An application for a certificate of need must contain:
675 (a) A detailed description of the proposed project and
676 statement of its purpose and need in relation to the district
677 health plan.
678 (b) A statement of the financial resources needed by and
679 available to the applicant to accomplish the proposed project.
680 This statement must include:
681 1. A complete listing of all capital projects, including
682 new health facility development projects and health facility
683 acquisitions applied for, pending, approved, or underway in any
684 state at the time of application, regardless of whether or not
685 that state has a certificate-of-need program or a capital
686 expenditure review program pursuant to s. 1122 of the Social
687 Security Act. The agency may, by rule, require less-detailed
688 information from major health care providers. This listing must
689 include the applicant’s actual or proposed financial commitment
690 to those projects and an assessment of their impact on the
691 applicant’s ability to provide the proposed project.
692 2. A detailed listing of the needed capital expenditures,
693 including sources of funds.
694 3. A detailed financial projection, including a statement
695 of the projected revenue and expenses for the first 2 years of
696 operation after completion of the proposed project. This
697 statement must include a detailed evaluation of the impact of
698 the proposed project on the cost of other services provided by
699 the applicant.
700 (c) An audited financial statement of the applicant or the
701 applicant’s parent corporation if audited financial statements
702 of the applicant do not exist. In an application submitted by an
703 existing health care facility, health maintenance organization,
704 or hospice, financial condition documentation must include, but
705 need not be limited to, a balance sheet and a profit-and-loss
706 statement of the 2 previous fiscal years’ operation.
707 (2) An application for a certificate of need for a general
708 hospital must contain a detailed description of the proposed
709 general hospital project and a statement of its purpose and the
710 needs it will meet. The proposed project’s location, as well as
711 its primary and secondary service areas, must be identified by
712 zip code. Primary service area is defined as the zip codes from
713 which the applicant projects that it will draw 75 percent of its
714 discharges. Secondary service area is defined as the zip codes
715 from which the applicant projects that it will draw its
716 remaining discharges. If, subsequent to issuance of a final
717 order approving the certificate of need, the proposed location
718 of the general hospital changes or the primary service area
719 materially changes, the agency shall revoke the certificate of
720 need. However, if the agency determines that such changes are
721 deemed to enhance access to hospital services in the service
722 district, the agency may permit such changes to occur. A party
723 participating in the administrative hearing regarding the
724 issuance of the certificate of need for a general hospital has
725 standing to participate in any subsequent proceeding regarding
726 the revocation of the certificate of need for a hospital for
727 which the location has changed or for which the primary service
728 area has materially changed. In addition, the application for
729 the certificate of need for a general hospital must include a
730 statement of intent that, if approved by final order of the
731 agency, the applicant shall within 120 days after issuance of
732 the final order or, if there is an appeal of the final order,
733 within 120 days after the issuance of the court’s mandate on
734 appeal, furnish satisfactory proof of the applicant’s financial
735 ability to operate. The agency shall establish documentation
736 requirements, to be completed by each applicant, which show
737 anticipated provider revenues and expenditures, the basis for
738 financing the anticipated cash-flow requirements of the
739 provider, and an applicant’s access to contingency financing. A
740 party participating in the administrative hearing regarding the
741 issuance of the certificate of need for a general hospital may
742 provide written comments concerning the adequacy of the
743 financial information provided, but such party does not have
744 standing to participate in an administrative proceeding
745 regarding proof of the applicant’s financial ability to operate.
746 The agency may require a licensee to provide proof of financial
747 ability to operate at any time if there is evidence of financial
748 instability, including, but not limited to, unpaid expenses
749 necessary for the basic operations of the provider.
750 (2)(3) The applicant must certify that it will license and
751 operate the health care facility. For an existing health care
752 facility, the applicant must be the licenseholder of the
753 facility.
754 Section 6. Paragraphs (c) and (d) of subsection (3),
755 paragraphs (b) and (c) of subsection (5), and paragraph (d) of
756 subsection (6) of section 408.039, Florida Statutes, are amended
757 to read:
758 408.039 Review process.—The review process for certificates
759 of need shall be as follows:
760 (3) APPLICATION PROCESSING.—
761 (c) Except for competing applicants, in order to be
762 eligible to challenge the agency decision on a general hospital
763 application under review pursuant to paragraph (5)(c), existing
764 hospitals must submit a detailed written statement of opposition
765 to the agency and to the applicant. The detailed written
766 statement must be received by the agency and the applicant
767 within 21 days after the general hospital application is deemed
768 complete and made available to the public.
769 (d) In those cases where a written statement of opposition
770 has been timely filed regarding a certificate of need
771 application for a general hospital, the applicant for the
772 general hospital may submit a written response to the agency.
773 Such response must be received by the agency within 10 days of
774 the written statement due date.
775 (5) ADMINISTRATIVE HEARINGS.—
776 (b) Hearings shall be held in Tallahassee unless the
777 administrative law judge determines that changing the location
778 will facilitate the proceedings. The agency shall assign
779 proceedings requiring hearings to the Division of Administrative
780 Hearings of the Department of Management Services within 10 days
781 after the time has expired for requesting a hearing. Except upon
782 unanimous consent of the parties or upon the granting by the
783 administrative law judge of a motion of continuance, hearings
784 shall commence within 60 days after the administrative law judge
785 has been assigned. For an application for a general hospital,
786 administrative hearings shall commence within 6 months after the
787 administrative law judge has been assigned, and a continuance
788 may not be granted absent a finding of extraordinary
789 circumstances by the administrative law judge. All parties,
790 except the agency, shall bear their own expense of preparing a
791 transcript. In any application for a certificate of need which
792 is referred to the Division of Administrative Hearings for
793 hearing, the administrative law judge shall complete and submit
794 to the parties a recommended order as provided in ss. 120.569
795 and 120.57. The recommended order shall be issued within 30 days
796 after the receipt of the proposed recommended orders or the
797 deadline for submission of such proposed recommended orders,
798 whichever is earlier. The division shall adopt procedures for
799 administrative hearings which shall maximize the use of
800 stipulated facts and shall provide for the admission of prepared
801 testimony.
802 (c) In administrative proceedings challenging the issuance
803 or denial of a certificate of need, only applicants considered
804 by the agency in the same batching cycle are entitled to a
805 comparative hearing on their applications. Existing health care
806 facilities may initiate or intervene in an administrative
807 hearing upon a showing that an established program will be
808 substantially affected by the issuance of any certificate of
809 need, whether reviewed under s. 408.036(1) or (2), to a
810 competing proposed facility or program within the same district.
811 With respect to an application for a general hospital, competing
812 applicants and only those existing hospitals that submitted a
813 detailed written statement of opposition to an application as
814 provided in this paragraph may initiate or intervene in an
815 administrative hearing. Such challenges to a general hospital
816 application shall be limited in scope to the issues raised in
817 the detailed written statement of opposition that was provided
818 to the agency. The administrative law judge may, upon a motion
819 showing good cause, expand the scope of the issues to be heard
820 at the hearing. Such motion shall include substantial and
821 detailed facts and reasons for failure to include such issues in
822 the original written statement of opposition.
823 (6) JUDICIAL REVIEW.—
824 (d) The party appealing a final order that grants a general
825 hospital certificate of need shall pay the appellee’s attorney’s
826 fees and costs, in an amount up to $1 million, from the
827 beginning of the original administrative action if the appealing
828 party loses the appeal, subject to the following limitations and
829 requirements:
830 1. The party appealing a final order must post a bond in
831 the amount of $1 million in order to maintain the appeal.
832 2. Except as provided under s. 120.595(5), in no event
833 shall the agency be held liable for any other party’s attorney’s
834 fees or costs.
835 Section 7. Subsection (1) of section 408.043, Florida
836 Statutes, is amended to read:
837 408.043 Special provisions.—
838 (1) OSTEOPATHIC ACUTE CARE HOSPITALS.—When an application
839 is made for a certificate of need to construct or to expand an
840 osteopathic acute care hospital, the need for such hospital
841 shall be determined on the basis of the need for and
842 availability of osteopathic services and osteopathic acute care
843 hospitals in the district. When a prior certificate of need to
844 establish an osteopathic acute care hospital has been issued in
845 a district, and the facility is no longer used for that purpose,
846 the agency may continue to count such facility and beds as an
847 existing osteopathic facility in any subsequent application for
848 construction of an osteopathic acute care hospital.
849 Section 8. Paragraph (f) of subsection (1) of section
850 395.1055, Florida Statutes, is amended to read:
851 395.1055 Rules and enforcement.—
852 (1) The agency shall adopt rules pursuant to ss. 120.536(1)
853 and 120.54 to implement the provisions of this part, which shall
854 include reasonable and fair minimum standards for ensuring that:
855 (f) All hospitals providing pediatric cardiac
856 catheterization, pediatric open-heart surgery, organ
857 transplantation, neonatal intensive care services, psychiatric
858 services, or comprehensive medical rehabilitation meet the
859 minimum licensure requirements adopted by the agency. Such
860 licensure requirements shall include quality of care, nurse
861 staffing, physician staffing, physical plant, equipment,
862 emergency transportation, and data reporting standards submit
863 such data as necessary to conduct certificate-of-need reviews
864 required under part I of chapter 408. Such data shall include,
865 but shall not be limited to, patient origin data, hospital
866 utilization data, type of service reporting, and facility
867 staffing data. The agency may not collect data that identifies
868 or could disclose the identity of individual patients. The
869 agency shall utilize existing uniform statewide data sources
870 when available and shall minimize reporting costs to hospitals.
871 Section 9. Section 395.6025, Florida Statutes, is repealed.
872 Section 10. Subsection (1) of section 395.603, Florida
873 Statutes, is amended to read:
874 395.603 Deactivation of general hospital beds; rural
875 hospital impact statement.—
876 (1) The agency shall establish, by rule, a process by which
877 a rural hospital, as defined in s. 395.602, that seeks licensure
878 as a rural primary care hospital or as an emergency care
879 hospital, or becomes a certified rural health clinic as defined
880 in Pub. L. No. 95-210, or becomes a primary care program such as
881 a county health department, community health center, or other
882 similar outpatient program that provides preventive and curative
883 services, may deactivate general hospital beds. Rural primary
884 care hospitals and emergency care hospitals shall maintain the
885 number of actively licensed general hospital beds necessary for
886 the facility to be certified for Medicare reimbursement.
887 Hospitals that discontinue inpatient care to become rural health
888 care clinics or primary care programs shall deactivate all
889 licensed general hospital beds. All hospitals, clinics, and
890 programs with inactive beds shall provide 24-hour emergency
891 medical care by staffing an emergency room. Providers with
892 inactive beds shall be subject to the criteria in s. 395.1041.
893 The agency shall specify in rule requirements for making 24-hour
894 emergency care available. Inactive general hospital beds shall
895 be included in the acute care bed inventory, maintained by the
896 agency for certificate-of-need purposes, for 10 years from the
897 date of deactivation of the beds. After 10 years have elapsed,
898 inactive beds shall be excluded from the inventory. The agency
899 shall, at the request of the licensee, reactivate the inactive
900 general beds upon a showing by the licensee that licensure
901 requirements for the inactive general beds are met.
902 Section 11. Subsection (1) of section 395.604, Florida
903 Statutes, is amended to read:
904 395.604 Other rural hospital programs.—
905 (1) The agency may license rural primary care hospitals
906 subject to federal approval for participation in the Medicare
907 and Medicaid programs. Rural primary care hospitals shall be
908 treated in the same manner as emergency care hospitals and rural
909 hospitals with respect to ss. 395.605(2)-(7)(a) 395.605(2)
910 (8)(a), 408.033(2)(b)3., and 408.038.
911 Section 12. Subsection (5) of section 395.605, Florida
912 Statutes, is amended to read:
913 395.605 Emergency care hospitals.—
914 (5) Rural hospitals that make application under the
915 certificate-of-need program to be licensed as emergency care
916 hospitals shall receive expedited review as defined in s.
917 408.032. Emergency care hospitals seeking relicensure as acute
918 care general hospitals shall also receive expedited review.
919 Section 13. Paragraph (b) of subsection (1) of section
920 408.033, Florida Statutes, is amended to read:
921 408.033 Local and state health planning.—
922 (1) LOCAL HEALTH COUNCILS.—
923 (b) Each local health council may:
924 1. Develop a district area health plan that permits each
925 local health council to develop strategies and set priorities
926 for implementation based on its unique local health needs.
927 2. Advise the agency on health care issues and resource
928 allocations.
929 3. Promote public awareness of community health needs,
930 emphasizing health promotion and cost-effective health service
931 selection.
932 4. Collect data and conduct analyses and studies related to
933 health care needs of the district, including the needs of
934 medically indigent persons, and assist the agency and other
935 state agencies in carrying out data collection activities that
936 relate to the functions in this subsection.
937 5. Monitor the onsite construction progress, if any, of
938 certificate-of-need approved projects and report council
939 findings to the agency on forms provided by the agency.
940 6. Advise and assist any regional planning councils within
941 each district that have elected to address health issues in
942 their strategic regional policy plans with the development of
943 the health element of the plans to address the health goals and
944 policies in the State Comprehensive Plan.
945 7. Advise and assist local governments within each district
946 on the development of an optional health plan element of the
947 comprehensive plan provided in chapter 163, to assure
948 compatibility with the health goals and policies in the State
949 Comprehensive Plan and district health plan. To facilitate the
950 implementation of this section, the local health council shall
951 annually provide the local governments in its service area, upon
952 request, with:
953 a. A copy and appropriate updates of the district health
954 plan;
955 b. A report of health facility hospital and nursing home
956 utilization statistics for facilities within the local
957 government jurisdiction; and
958 c. Applicable agency rules and calculated need
959 methodologies for health facilities and services regulated under
960 s. 408.034 for the district served by the local health council.
961 8. Monitor and evaluate the adequacy, appropriateness, and
962 effectiveness, within the district, of local, state, federal,
963 and private funds distributed to meet the needs of the medically
964 indigent and other underserved population groups.
965 9. In conjunction with the Department of Health, plan for
966 services at the local level for persons infected with the human
967 immunodeficiency virus.
968 10. Provide technical assistance to encourage and support
969 activities by providers, purchasers, consumers, and local,
970 regional, and state agencies in meeting the health care goals,
971 objectives, and policies adopted by the local health council.
972 11. Provide the agency with data required by rule for the
973 review of certificate-of-need applications and the projection of
974 need for health services and facilities in the district.
975 Section 14. Subsections (2) and (4) of section 408.0361,
976 Florida Statutes, are amended to read:
977 408.0361 Cardiovascular services and burn unit licensure.—
978 (2) Each provider of adult cardiovascular services or
979 operator of a burn unit shall comply with rules adopted by the
980 agency that establish licensure standards that govern the
981 provision of adult cardiovascular services or the operation of a
982 burn unit. Such rules shall consider, at a minimum, staffing,
983 equipment, physical plant, operating protocols, the provision of
984 services to Medicaid and charity care patients, accreditation,
985 licensure period and fees, and enforcement of minimum standards.
986 The certificate-of-need rules for adult cardiovascular services
987 and burn units in effect on June 30, 2004, are authorized
988 pursuant to this subsection and shall remain in effect and shall
989 be enforceable by the agency until the licensure rules are
990 adopted. Existing providers and any provider with a notice of
991 intent to grant a certificate of need or a final order of the
992 agency granting a certificate of need for adult cardiovascular
993 services or burn units shall be considered grandfathered and
994 receive a license for their programs effective on the effective
995 date of this act. The grandfathered licensure shall be for at
996 least 3 years or until July 1, 2008, whichever is longer, but
997 shall be required to meet licensure standards applicable to
998 existing programs for every subsequent licensure period.
999 (4) In order to ensure continuity of available services,
1000 the holder of a certificate of need for a newly licensed
1001 hospital that meets the requirements of this subsection may
1002 apply for and shall be granted Level I program status regardless
1003 of whether rules relating to Level I programs have been adopted.
1004 To qualify for a Level I program under this subsection, a
1005 hospital seeking a Level I program must be a newly licensed
1006 hospital established pursuant to a certificate of need in a
1007 physical location previously licensed and operated as a
1008 hospital, the former hospital must have provided a minimum of
1009 300 adult inpatient and outpatient diagnostic cardiac
1010 catheterizations for the most recent 12-month period as reported
1011 to the agency, and the newly licensed hospital must have a
1012 formalized, written transfer agreement with a hospital that has
1013 a Level II program, including written transport protocols to
1014 ensure safe and efficient transfer of a patient within 60
1015 minutes. A hospital meeting the requirements of this subsection
1016 may apply for certification of Level I program status before
1017 taking possession of the physical location of the former
1018 hospital, and the effective date of Level I program status shall
1019 be concurrent with the effective date of the newly issued
1020 hospital license.
1021 Section 15. This act shall take effect July 1, 2018.
