1 | A bill to be entitled |
2 | An act relating to certificates of need; amending s. |
3 | 395.003, F.S.; prohibiting the Agency for Health Care |
4 | Administration from issuing or renewing a hospital's |
5 | license if more than a specified percentage of the |
6 | hospital's patients receive care and treatment classified |
7 | in specified diagnostic-related groups; providing an |
8 | exemption; authorizing the agency to adopt rules; amending |
9 | s. 408.032, F.S.; revising definitions relating to health |
10 | facilities and services; amending s. 408.033, F.S.; |
11 | requiring that local health councils serve counties in a |
12 | health service planning district; directing the local |
13 | health council to develop a plan for services at the local |
14 | level with the Department of Health; providing for the |
15 | costs of operating a local health council to come from |
16 | assessments imposed on selected health care facilities; |
17 | directing the department to enter into contracts with the |
18 | local health councils for certain services; amending s. |
19 | 408.034, F.S.; conforming provisions to changes made by |
20 | the act; amending s. 408.035, F.S.; revising criteria for |
21 | reviewing an application for a certificate-of-need; |
22 | amending s. 408.036, F.S.; revising health-care-related |
23 | projects that are subject to the certificate-of-need |
24 | process; revising health-care-related projects that are |
25 | subject to an expedited certificate-of-need process; |
26 | revising the list of projects exempt from the certificate- |
27 | of-need process; requiring health care facilities and |
28 | providers to notify the agency of certain specified |
29 | activities; amending s. 408.0361, F.S.; requiring the |
30 | agency to adopt rules for licensure standards for adult |
31 | interventional cardiology services and burn units; |
32 | providing minimum criteria for inclusion in the rules; |
33 | providing that certain health care providers of adult |
34 | interventional cardiology services are exempt from |
35 | complying with the rules for 2 years following the date of |
36 | their next license renewal, but must meet the licensure |
37 | standards thereafter; requiring the agency to license two |
38 | levels of treatment for adult interventional cardiology |
39 | services; providing criteria for the two levels of |
40 | licensure; directing the Secretary of Health Care |
41 | Administration to appoint an advisory group to study the |
42 | issue of replacing certificate-of-need review of organ |
43 | transplant programs operating under ch. 408, F.S., with |
44 | licensure regulation of organ transplant programs under |
45 | ch. 395, F.S.; providing for membership; requiring the |
46 | advisory group to make certain recommendations; directing |
47 | the advisory group to submit a report to the Governor, the |
48 | secretary, and the Legislature by a specific date; |
49 | amending s. 408.038, F.S.; increasing fees for |
50 | certificate-of-need applications; amending s. 408.039, |
51 | F.S.; providing for an annual review cycle for |
52 | certificate-of-need applications; revising the review |
53 | procedures; amending s. 408.040, F.S.; providing for |
54 | conditions and monitoring for holders of a certificate of |
55 | need or an exemption certificate; providing that failure |
56 | to report to the agency constitutes noncompliance with |
57 | conditions of the certificate; amending s. 408.0455, F.S.; |
58 | providing that rules of the agency in effect on June 30, |
59 | 2004, shall remain in effect until amended or repealed; |
60 | repealing s. 408.043(2), F.S., relating to special |
61 | provisions for hospice facilities; repealing s. 408.045, |
62 | F.S., relating to the use of a competitive sealed proposal |
63 | to obtain a certificate of need for an intermediate care |
64 | facility for the developmentally disabled; providing an |
65 | effective date. |
66 |
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67 | WHEREAS, the Legislature finds that it is essential for the |
68 | public health and safety of this state that general hospitals be |
69 | available to serve the residents of this state, and |
70 | WHEREAS, the Legislature finds that over 60 general |
71 | hospitals have closed in this state and the Legislature is |
72 | concerned that more hospitals may close, and |
73 | WHEREAS, the Legislature finds that creating hospitals that |
74 | provide limited services will serve only paying patients and may |
75 | cause harm to the continued existence of general hospitals |
76 | serving broad populations of this state, and |
77 | WHEREAS, the Legislature finds that creating hospitals that |
78 | provide limited services may limit or eliminate competitive |
79 | alternatives in the health care service market; may result in |
80 | over-utilization of certain high-cost health care services, such |
81 | as cardiac, orthopedic, and cancer services; may increase costs |
82 | to the health care system; and may adversely affect the quality |
83 | of health care, NOW, THEREFORE, |
84 |
|
85 | Be It Enacted by the Legislature of the State of Florida: |
86 |
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87 | Section 1. Subsection (9) is added to section 395.003, |
88 | Florida Statutes, to read: |
89 | 395.003 Licensure; issuance, renewal, denial, |
90 | modification, suspension, and revocation.-- |
91 | (9)(a) A hospital may not be licensed under this part, or |
92 | have its license renewed, if 65 percent or more of its |
93 | discharged patients, as reported to the Agency for Health Care |
94 | Administration under s. 408.061, received diagnosis, care, and |
95 | treatment within the following diagnostic-related groups: |
96 | 1. Cardiac-related diseases and disorders classified as |
97 | DRGs 103-145, 478-479, 514-518, 525-527; |
98 | 2. Orthopedic-related diseases and disorders classified as |
99 | DRGs 209-256, 471, 491, 496-503, 519-520; |
100 | 3. Cancer-related diseases and disorders classified as |
101 | DRGs 64, 82, 172, 173, 199, 200, 203, 257-260, 274, 275, 303, |
102 | 306, 307, 318, 319, 338, 344, 346, 347, 363, 366, 367, 400-414, |
103 | 473, 492; or |
104 | 4. Any combination of the above discharges. |
105 |
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106 | The agency may not issue or renew a hospital's license if the |
107 | hospital's actual discharges in the most recent year for which |
108 | data is available, or the projected discharges over the next 12 |
109 | months, meet the criteria of this subsection. The agency shall |
110 | revoke a hospital's license if the hospital fails to meet these |
111 | criteria during any year of operation. |
112 | (b) Hospitals licensed on or before June 1, 2004, shall be |
113 | exempt from the requirements in this subsection if the hospital |
114 | maintains the same ownership, facility street address, and range |
115 | of services provided on June 1, 2004. |
116 | (c) The agency may adopt rules to administer this |
117 | subsection. However, the statutory requirements are applicable |
118 | on July 1, 2004. In any administrative proceeding challenging |
119 | the denial or revocation of a hospital's license under this |
120 | subsection, the hearing shall be based on the facts and law in |
121 | effect at the time of the agency's proposed agency action. Any |
122 | hospital may initiate or intervene in an administrative hearing |
123 | to deny or revoke the license of a competing hospital located |
124 | within the same district or service area on a showing that one |
125 | of the hospital's established programs will be substantially |
126 | affected if a license is issued to the competing hospital. |
127 | Section 2. Section 408.032, Florida Statutes, is amended |
128 | to read: |
129 | 408.032 Definitions relating to Health Facility and |
130 | Services Development Act.--As used in ss. 408.031-408.045, the |
131 | term: |
132 | (1) "Agency" means the Agency for Health Care |
133 | Administration. |
134 | (2) "Capital expenditure" means an expenditure, including |
135 | an expenditure for a construction project undertaken by a health |
136 | care facility as its own contractor, which, under generally |
137 | accepted accounting principles, is not properly chargeable as an |
138 | expense of operation and maintenance, which is made to change |
139 | the bed capacity of the facility, or substantially change the |
140 | services or service area of the health care facility, health |
141 | service provider, or hospice, and which includes the cost of the |
142 | studies, surveys, designs, plans, working drawings, |
143 | specifications, initial financing costs, and other activities |
144 | essential to acquisition, improvement, expansion, or replacement |
145 | of the plant and equipment. |
146 | (3) "Certificate of need" means a written statement issued |
147 | by the agency evidencing community need for a new, converted, |
148 | expanded, or otherwise significantly modified health care |
149 | facility, health service, or hospice. |
150 | (4) "Commenced construction" means initiation of and |
151 | continuous activities beyond site preparation associated with |
152 | erecting or modifying a health care facility, including |
153 | procurement of a building permit applying the use of agency- |
154 | approved construction documents, proof of an executed |
155 | owner/contractor agreement or an irrevocable or binding forced |
156 | account, and actual undertaking of foundation forming with steel |
157 | installation and concrete placing. |
158 | (5) "District" means a health service planning district |
159 | composed of the following counties: |
160 | District 1.--Escambia, Santa Rosa, Okaloosa, and Walton |
161 | Counties. |
162 | District 2.--Holmes, Washington, Bay, Jackson, Franklin, |
163 | Gulf, Gadsden, Liberty, Calhoun, Leon, Wakulla, Jefferson, |
164 | Madison, and Taylor Counties. |
165 | District 3.--Hamilton, Suwannee, Lafayette, Dixie, |
166 | Columbia, Gilchrist, Levy, Union, Bradford, Putnam, Alachua, |
167 | Marion, Citrus, Hernando, Sumter, and Lake Counties. |
168 | District 4.--Baker, Nassau, Duval, Clay, St. Johns, |
169 | Flagler, and Volusia Counties. |
170 | District 5.--Pasco and Pinellas Counties. |
171 | District 6.--Hillsborough, Manatee, Polk, Hardee, and |
172 | Highlands Counties. |
173 | District 7.--Seminole, Orange, Osceola, and Brevard |
174 | Counties. |
175 | District 8.--Sarasota, DeSoto, Charlotte, Lee, Glades, |
176 | Hendry, and Collier Counties. |
177 | District 9.--Indian River, Okeechobee, St. Lucie, Martin, |
178 | and Palm Beach Counties. |
179 | District 10.--Broward County. |
180 | District 11.--Dade and Monroe Counties. |
181 | (6) "Exemption" means the process by which a proposal that |
182 | would otherwise require a certificate of need may proceed |
183 | without a certificate of need. |
184 | (7) "Expedited review" means the process by which certain |
185 | types of applications are not subject to the review cycle |
186 | requirements contained in s. 408.039(1), and the letter of |
187 | intent requirements contained in s. 408.039(2). |
188 | (8) "Health care facility" means a hospital, long-term |
189 | care hospital, skilled nursing facility, hospice, or |
190 | intermediate care facility for the developmentally disabled. A |
191 | facility relying solely on spiritual means through prayer for |
192 | healing is not included as a health care facility. |
193 | (9) "Health services" means inpatient diagnostic, |
194 | curative, or comprehensive medical rehabilitative services and |
195 | includes mental health services. Obstetric services are not |
196 | health services for purposes of ss. 408.031-408.045. |
197 | (10) "Hospice" or "hospice program" means a hospice as |
198 | defined in part VI of chapter 400. |
199 | (11) "Hospital" means a health care facility licensed |
200 | under chapter 395. |
201 | (12) "Intermediate care facility for the developmentally |
202 | disabled" means a residential facility licensed under chapter |
203 | 393 and certified by the Federal Government under pursuant to |
204 | the Social Security Act as a provider of Medicaid services to |
205 | persons who are mentally retarded or who have a related |
206 | condition. |
207 | (13) "Long-term care hospital" means a hospital licensed |
208 | under chapter 395 which meets the requirements of 42 C.F.R. s. |
209 | 412.23(e) and seeks exclusion from the acute care Medicare |
210 | prospective payment system for inpatient hospital services. |
211 | (14) "Mental health services" means inpatient services |
212 | provided in a hospital licensed under chapter 395 and listed on |
213 | the hospital license as psychiatric beds for adults; psychiatric |
214 | beds for children and adolescents; intensive residential |
215 | treatment beds for children and adolescents; substance abuse |
216 | beds for adults; or substance abuse beds for children and |
217 | adolescents. |
218 | (15) "Nursing home geographically underserved area" means: |
219 | (a) A county in which there is no existing or approved |
220 | nursing home; |
221 | (b) An area with a radius of at least 20 miles in which |
222 | there is no existing or approved nursing home; or |
223 | (c) An area with a radius of at least 20 miles in which |
224 | all existing nursing homes have maintained at least a 95 percent |
225 | occupancy rate for the most recent 6 months or a 90 percent |
226 | occupancy rate for the most recent 12 months. |
227 | (16) "Skilled nursing facility" means an institution, or a |
228 | distinct part of an institution, which is primarily engaged in |
229 | providing, to inpatients, skilled nursing care and related |
230 | services for patients who require medical or nursing care, or |
231 | rehabilitation services for the rehabilitation of injured, |
232 | disabled, or sick persons. |
233 | (17) "Tertiary health service" means a health service |
234 | which, due to its high level of intensity, complexity, |
235 | specialized or limited applicability, and cost, should be |
236 | limited to, and concentrated in, a limited number of hospitals |
237 | to ensure the quality, availability, and cost-effectiveness of |
238 | the such service. Examples of this such service include, but are |
239 | not limited to, pediatric cardiac catheterization, pediatric |
240 | open-heart surgery, organ transplantation, specialty burn units, |
241 | neonatal intensive care units, comprehensive rehabilitation, and |
242 | medical or surgical services that which are experimental or |
243 | developmental in nature to the extent that providing the the |
244 | provision of such services is not yet contemplated within the |
245 | commonly accepted course of diagnosis or treatment for the |
246 | condition addressed by a given service. The agency shall |
247 | establish by rule a list of all tertiary health services. |
248 | (18) "Regional area" means any of those regional health |
249 | planning areas established by the agency to which local and |
250 | district health planning funds are directed to local health |
251 | councils through the General Appropriations Act. |
252 | Section 3. Section 408.033, Florida Statutes, is amended |
253 | to read: |
254 | 408.033 Local and state health planning.-- |
255 | (1) LOCAL HEALTH COUNCILS.-- |
256 | (a) Local health councils are hereby established as public |
257 | or private nonprofit agencies serving the counties of a district |
258 | or regional area of the agency. The members of each council |
259 | shall be appointed in an equitable manner by the county |
260 | commissions having jurisdiction in the respective district. Each |
261 | council shall be composed of a number of persons equal to 1 1/2 |
262 | times the number of counties that which compose the district or |
263 | 12 members, whichever is greater. Each county in a district |
264 | shall be entitled to at least one member on the council. The |
265 | balance of the membership of the council shall be allocated |
266 | among the counties of the district on the basis of population |
267 | rounded to the nearest whole number; except that in a district |
268 | composed of only two counties, no county shall have fewer than |
269 | four members. The appointees shall be representatives of health |
270 | care providers, health care purchasers, and nongovernmental |
271 | health care consumers, but not excluding elected government |
272 | officials. The members of the consumer group shall include a |
273 | representative number of persons over 60 years of age. A |
274 | majority of council members shall consist of health care |
275 | purchasers and health care consumers. The local health council |
276 | shall provide each county commission a schedule for appointing |
277 | council members to ensure that council membership complies with |
278 | the requirements of this paragraph. The members of the local |
279 | health council shall elect a chair. Members shall serve for |
280 | terms of 2 years and may be eligible for reappointment. |
281 | (b) Each local health council may: |
282 | 1. Develop a district or regional area health plan that |
283 | permits each local health council to develop strategies and set |
284 | priorities for implementation based on its unique local health |
285 | needs. The district or regional area health plan must contain |
286 | preferences for the development of health services and |
287 | facilities, which may be considered by the agency in its review |
288 | of certificate-of-need applications. The district health plan |
289 | shall be submitted to the agency and updated periodically. The |
290 | district health plans shall use a uniform format and be |
291 | submitted to the agency according to a schedule developed by the |
292 | agency in conjunction with the local health councils. The |
293 | schedule must provide for the development of district health |
294 | plans by major sections over a multiyear period. The elements |
295 | of a district plan which are necessary to the review of |
296 | certificate-of-need applications for proposed projects within |
297 | the district may be adopted by the agency as a part of its |
298 | rules. |
299 | 2. Advise the agency on health care issues and resource |
300 | allocations. |
301 | 3. Promote public awareness of community health needs, |
302 | emphasizing health promotion and cost-effective health service |
303 | selection. |
304 | 4. Collect data and conduct analyses and studies related |
305 | to health care needs of the district, including the needs of |
306 | medically indigent persons, and assist the agency and other |
307 | state agencies in carrying out data collection activities that |
308 | relate to the functions in this subsection. |
309 | 5. Monitor the onsite construction progress, if any, of |
310 | certificate-of-need approved projects and report council |
311 | findings to the agency on forms provided by the agency. |
312 | 6. Advise and assist any regional planning councils within |
313 | each district that have elected to address health issues in |
314 | their strategic regional policy plans with the development of |
315 | the health element of the plans to address the health goals and |
316 | policies in the State Comprehensive Plan. |
317 | 7. Advise and assist local governments within each |
318 | district on the development of an optional health plan element |
319 | of the comprehensive plan provided in chapter 163, to assure |
320 | compatibility with the health goals and policies in the State |
321 | Comprehensive Plan and district health plan. To facilitate the |
322 | implementation of this section, the local health council shall |
323 | annually provide the local governments in its service area, upon |
324 | request, with: |
325 | a. A copy and appropriate updates of the district health |
326 | plan; |
327 | b. A report of hospital and nursing home utilization |
328 | statistics for facilities within the local government |
329 | jurisdiction; and |
330 | c. Applicable agency rules and calculated need |
331 | methodologies for health facilities and services regulated under |
332 | s. 408.034 for the district served by the local health council. |
333 | 8. Monitor and evaluate the adequacy, appropriateness, and |
334 | effectiveness, within the district, of local, state, federal, |
335 | and private funds distributed to meet the needs of the medically |
336 | indigent and other underserved population groups. |
337 | 9. In conjunction with the Department of Health Agency for |
338 | Health Care Administration, plan for services at the local level |
339 | for persons infected with the human immunodeficiency virus. |
340 | 10. Provide technical assistance to encourage and support |
341 | activities by providers, purchasers, consumers, and local, |
342 | regional, and state agencies in meeting the health care goals, |
343 | objectives, and policies adopted by the local health council. |
344 | 11. Provide the agency with data required by rule for the |
345 | review of certificate-of-need applications and the projection of |
346 | need for health services and facilities in the district. |
347 | (c) Local health councils may conduct public hearings |
348 | under pursuant to s. 408.039(3)(b). |
349 | (d) Each local health council shall enter into a |
350 | memorandum of agreement with each regional planning council in |
351 | its district that elects to address health issues in its |
352 | strategic regional policy plan. In addition, each local health |
353 | council shall enter into a memorandum of agreement with each |
354 | local government that includes an optional health element in its |
355 | comprehensive plan. Each memorandum of agreement must specify |
356 | the manner in which each local government, regional planning |
357 | council, and local health council will coordinate its activities |
358 | to ensure a unified approach to health planning and |
359 | implementation efforts. |
360 | (e) Local health councils may employ personnel or contract |
361 | for staffing services with persons who possess appropriate |
362 | qualifications to carry out the councils' purposes. However, |
363 | these such personnel are not state employees. |
364 | (f) Personnel of the local health councils shall provide |
365 | an annual orientation to council members about council member |
366 | responsibilities. The orientation shall include presentations |
367 | and participation by agency staff. |
368 | (g) Each local health council is authorized to accept and |
369 | receive, in furtherance of its health planning functions, funds, |
370 | grants, and services from governmental agencies and from private |
371 | or civic sources and to perform studies related to local health |
372 | planning in exchange for such funds, grants, or services. Each |
373 | local health council shall, no later than January 30 of each |
374 | year, render an accounting of the receipt and disbursement of |
375 | such funds received by it to the Department of Health agency. |
376 | The Department of Health agency shall consolidate all such |
377 | reports and submit such consolidated report to the Legislature |
378 | no later than March 1 of each year. Funds received by a local |
379 | health council pursuant to this paragraph shall not be deemed to |
380 | be a substitute for, or an offset against, any funding provided |
381 | pursuant to subsection (2). |
382 | (2) FUNDING.-- |
383 | (a) The Legislature intends that the cost of local health |
384 | councils be borne by application fees for certificates of need |
385 | and by assessments on selected health care facilities subject to |
386 | facility licensure by the Agency for Health Care Administration, |
387 | including abortion clinics, assisted living facilities, |
388 | ambulatory surgical centers, birthing centers, clinical |
389 | laboratories except community nonprofit blood banks and clinical |
390 | laboratories operated by practitioners for exclusive use |
391 | regulated under s. 483.035, home health agencies, hospices, |
392 | hospitals, intermediate care facilities for the developmentally |
393 | disabled, nursing homes, and multiphasic testing centers and by |
394 | assessments on organizations subject to certification by the |
395 | agency under pursuant to chapter 641, part III, including health |
396 | maintenance organizations and prepaid health clinics. |
397 | (b)1. A hospital licensed under chapter 395, a nursing |
398 | home licensed under chapter 400, and an assisted living facility |
399 | licensed under chapter 400 shall be assessed an annual fee based |
400 | on number of beds. |
401 | 2. All other facilities and organizations listed in |
402 | paragraph (a) shall each be assessed an annual fee of $150. |
403 | 3. Facilities operated by the Department of Children and |
404 | Family Services, the Department of Health, or the Department of |
405 | Corrections and any hospital that which meets the definition of |
406 | rural hospital under pursuant to s. 395.602 are exempt from the |
407 | assessment required in this subsection. |
408 | (c)1. The agency shall, by rule, establish fees for |
409 | hospitals and nursing homes based on an assessment of $2 per |
410 | bed. However, no such facility shall be assessed more than a |
411 | total of $500 under this subsection. |
412 | 2. The agency shall, by rule, establish fees for assisted |
413 | living facilities based on an assessment of $1 per bed. However, |
414 | no such facility shall be assessed more than a total of $150 |
415 | under this subsection. |
416 | 3. The agency shall, by rule, establish an annual fee of |
417 | $150 for all other facilities and organizations listed in |
418 | paragraph (a). |
419 | (d) The agency shall, by rule, establish a facility |
420 | billing and collection process for the billing and collection of |
421 | the health facility fees authorized by this subsection. |
422 | (e) A health facility which is assessed a fee under this |
423 | subsection is subject to a fine of $100 per day for each day in |
424 | which the facility is late in submitting its annual fee up to |
425 | maximum of the annual fee owed by the facility. A facility |
426 | which refuses to pay the fee or fine is subject to the |
427 | forfeiture of its license. |
428 | (f) The agency shall deposit in the Health Care Trust Fund |
429 | all health care facility assessments that are assessed under |
430 | this subsection and proceeds from the certificate-of-need |
431 | application fees. The agency shall transfer these funds to the |
432 | Department of Health for an amount sufficient to maintain the |
433 | aggregate funding of level for the local health councils as |
434 | specified in the General Appropriations Act. The remaining |
435 | certificate-of-need application fees shall be used only for the |
436 | purpose of administering the certificate-of-need program Health |
437 | Facility and Services Development Act. |
438 | (3) DUTIES AND RESPONSIBILITIES OF THE AGENCY.-- |
439 | (a) The agency, in conjunction with the local health |
440 | councils, is responsible for the coordinated planning of health |
441 | care services in the state. |
442 | (b) The agency shall develop and maintain a comprehensive |
443 | health care database for the purpose of health planning and for |
444 | certificate-of-need determinations. The agency or its |
445 | contractor is authorized to require the submission of |
446 | information from health facilities, health service providers, |
447 | and licensed health professionals which is determined by the |
448 | agency, through rule, to be necessary for meeting the agency's |
449 | responsibilities as established in this section. |
450 | (c) The agency shall assist personnel of the local health |
451 | councils in providing an annual orientation to council members |
452 | about council member responsibilities. |
453 | (c)(d) The Department of Health agency shall contract with |
454 | the local health councils for the services specified in |
455 | subsection (1). All contract funds shall be distributed |
456 | according to an allocation plan developed by the Department of |
457 | Health agency that provides for a minimum and equal funding base |
458 | for each local health council. Any remaining funds shall be |
459 | distributed based on adjustments for workload. The agency may |
460 | also make grants to or reimburse local health councils from |
461 | federal funds provided to the state for activities related to |
462 | those functions set forth in this section. The Department of |
463 | Health agency may withhold funds from a local health council or |
464 | cancel its contract with a local health council which does not |
465 | meet performance standards agreed upon by the Department of |
466 | Health agency and local health councils. |
467 | Section 4. Subsections (1) and (2) of section 408.034, |
468 | Florida Statutes, are amended to read: |
469 | 408.034 Duties and responsibilities of agency; rules.-- |
470 | (1) The agency is designated as the single state agency to |
471 | issue, revoke, or deny certificates of need and to issue, |
472 | revoke, or deny exemptions from certificate-of-need review in |
473 | accordance with the district plans and present and future |
474 | federal and state statutes. The agency is designated as the |
475 | state health planning agency for purposes of federal law. |
476 | (2) In the exercise of its authority to issue licenses to |
477 | health care facilities and health service providers, as provided |
478 | under chapters 393, 395, and parts II and VI of chapter 400, the |
479 | agency may not issue a license to any health care facility or, |
480 | health service provider that, hospice, or part of a health care |
481 | facility which fails to receive a certificate of need or an |
482 | exemption for the licensed facility or service. |
483 | Section 5. Section 408.035, Florida Statutes, is amended |
484 | to read: |
485 | 408.035 Review criteria.--The agency shall determine the |
486 | reviewability of applications and shall review applications for |
487 | certificate-of-need determinations for health care facilities |
488 | and health services in context with the following criteria: |
489 | (1) The need for the health care facilities and health |
490 | services being proposed in relation to the applicable district |
491 | health plan. |
492 | (2) The availability, quality of care, accessibility, and |
493 | extent of utilization of existing health care facilities and |
494 | health services in the service district of the applicant. |
495 | (3) The ability of the applicant to provide quality of |
496 | care and the applicant's record of providing quality of care. |
497 | (4) The need in the service district of the applicant for |
498 | special health care services that are not reasonably and |
499 | economically accessible in adjoining areas. |
500 | (5) The needs of research and educational facilities, |
501 | including, but not limited to, facilities with institutional |
502 | training programs and community training programs for health |
503 | care practitioners and for doctors of osteopathic medicine and |
504 | medicine at the student, internship, and residency training |
505 | levels. |
506 | (4)(6) The availability of resources, including health |
507 | personnel, management personnel, and funds for capital and |
508 | operating expenditures, for project accomplishment and |
509 | operation. |
510 | (5)(7) The extent to which the proposed services will |
511 | enhance access to health care for residents of the service |
512 | district. |
513 | (6)(8) The immediate and long-term financial feasibility |
514 | of the proposal. |
515 | (7)(9) The extent to which the proposal will foster |
516 | competition that promotes quality and cost-effectiveness. |
517 | (8)(10) The costs and methods of the proposed |
518 | construction, including the costs and methods of energy |
519 | provision and the availability of alternative, less costly, or |
520 | more effective methods of construction. |
521 | (9)(11) The applicant's past and proposed provision of |
522 | health care services to Medicaid patients and the medically |
523 | indigent. |
524 | (10)(12) The applicant's designation as a Gold Seal |
525 | Program nursing facility under pursuant to s. 400.235, when the |
526 | applicant is requesting additional nursing home beds at that |
527 | facility. |
528 | Section 6. Section 408.036, Florida Statutes, is amended |
529 | to read: |
530 | 408.036 Projects subject to review; exemptions.-- |
531 | (1) APPLICABILITY.--Unless exempt under subsection (3), |
532 | all health-care-related projects, as described in paragraphs |
533 | (a)-(e) (a)-(h), are subject to review and must file an |
534 | application for a certificate of need with the agency. The |
535 | agency is exclusively responsible for determining whether a |
536 | health-care-related project is subject to review under ss. |
537 | 408.031-408.045. |
538 | (a) The addition of community nursing home or ICF/DD beds |
539 | by new construction or alteration. |
540 | (b) The new construction or establishment of additional |
541 | health care facilities, including a replacement health care |
542 | facility when the proposed project site is not located on the |
543 | same site as, or within 1 mile of, the existing health care |
544 | facility, if the number of beds in each licensed bed category |
545 | will not increase. |
546 | (c) The conversion from one type of health care facility |
547 | to another, including the conversion from a general hospital, a |
548 | specialty hospital, or long-term care hospital. |
549 | (d) An increase in the total licensed bed capacity of a |
550 | health care facility. |
551 | (d)(e) The establishment of a hospice or hospice inpatient |
552 | facility, except as provided in s. 408.043. |
553 | (f) The establishment of inpatient health services by a |
554 | health care facility, or a substantial change in such services. |
555 | (g) An increase in the number of beds for acute care, |
556 | nursing home care beds, specialty burn units, neonatal intensive |
557 | care units, comprehensive rehabilitation, mental health |
558 | services, or hospital-based distinct part skilled nursing units, |
559 | or at a long-term care hospital. |
560 | (e)(h) The establishment of tertiary health services. |
561 | (2) PROJECTS SUBJECT TO EXPEDITED REVIEW.--Unless exempt |
562 | under pursuant to subsection (3), projects subject to an |
563 | expedited review shall include, but not be limited to: |
564 | (a) Research, education, and training programs. |
565 | (b) Shared services contracts or projects. |
566 | (a)(c) A transfer of a certificate of need, except that, |
567 | when an existing hospital is acquired by a purchaser, all |
568 | certificates of need issued to the hospital which are not yet |
569 | operational are acquired by the purchaser without need for a |
570 | transfer. |
571 | (b) Replacement of a community nursing home or ICF/DD when |
572 | the proposed project site is located within the same district |
573 | and the same planning area of the health care facility being |
574 | replaced, if the number of licensed beds in the proposed project |
575 | is the same as that of the facility being replaced. |
576 | (d) A 50-percent increase in nursing home beds for a |
577 | facility incorporated and operating in this state for at least |
578 | 60 years on or before July 1, 1988, which has a licensed nursing |
579 | home facility located on a campus providing a variety of |
580 | residential settings and supportive services. The increased |
581 | nursing home beds shall be for the exclusive use of the campus |
582 | residents. Any application on behalf of an applicant meeting |
583 | this requirement shall be subject to the base fee of $5,000 |
584 | provided in s. 408.038. |
585 | (e) Replacement of a health care facility when the |
586 | proposed project site is located in the same district and within |
587 | a 1-mile radius of the replaced health care facility. |
588 | (f) The conversion of mental health services beds licensed |
589 | under chapter 395 or hospital-based distinct part skilled |
590 | nursing unit beds to general acute care beds; the conversion of |
591 | mental health services beds between or among the licensed bed |
592 | categories defined as beds for mental health services; or the |
593 | conversion of general acute care beds to beds for mental health |
594 | services. |
595 | 1. Conversion under this paragraph shall not establish a |
596 | new licensed bed category at the hospital but shall apply only |
597 | to categories of beds licensed at that hospital. |
598 | 2. Beds converted under this paragraph must be licensed |
599 | and operational for at least 12 months before the hospital may |
600 | apply for additional conversion affecting beds of the same type. |
601 |
|
602 | The agency shall develop rules to implement the provisions for |
603 | expedited review, including time schedule, application content |
604 | which may be reduced from the full requirements of s. |
605 | 408.037(1), and application processing. |
606 | (3) EXEMPTIONS.--Upon request, the following projects are |
607 | subject to exemption from the provisions of subsection (1): |
608 | (a) For replacement of a licensed health care facility on |
609 | the same site, provided that the number of beds in each licensed |
610 | bed category will not increase. |
611 | (a)(b) For hospice services or for swing beds in a rural |
612 | hospital, as defined in s. 395.602, in a number that does not |
613 | exceed one-half of its licensed beds. |
614 | (b)(c) For the conversion of licensed acute care hospital |
615 | beds to Medicare and Medicaid certified skilled nursing beds in |
616 | a rural hospital, as defined in s. 395.602, so long as the |
617 | conversion of the beds does not involve the construction of new |
618 | facilities. The total number of skilled nursing beds, including |
619 | swing beds, may not exceed one-half of the total number of |
620 | licensed beds in the rural hospital as of July 1, 1993. |
621 | Certified skilled nursing beds designated under this paragraph, |
622 | excluding swing beds, shall be included in the community nursing |
623 | home bed inventory. A rural hospital which subsequently |
624 | decertifies any acute care beds exempted under this paragraph |
625 | shall notify the agency of the decertification, and the agency |
626 | shall adjust the community nursing home bed inventory |
627 | accordingly. |
628 | (c)(d) For the addition of nursing home beds at a skilled |
629 | nursing facility that is part of a retirement community that |
630 | provides a variety of residential settings and supportive |
631 | services and that has been incorporated and operated in this |
632 | state for at least 65 years on or before July 1, 1994. All |
633 | nursing home beds must not be available to the public but must |
634 | be for the exclusive use of the community residents. |
635 | (e) For an increase in the bed capacity of a nursing |
636 | facility licensed for at least 50 beds as of January 1, 1994, |
637 | under part II of chapter 400 which is not part of a continuing |
638 | care facility if, after the increase, the total licensed bed |
639 | capacity of that facility is not more than 60 beds and if the |
640 | facility has been continuously licensed since 1950 and has |
641 | received a superior rating on each of its two most recent |
642 | licensure surveys. |
643 | (d)(f) For an inmate health care facility built by or for |
644 | the exclusive use of the Department of Corrections as provided |
645 | in chapter 945. This exemption expires when the such facility is |
646 | converted to other uses. |
647 | (g) For the termination of an inpatient health care |
648 | service, upon 30 days' written notice to the agency. |
649 | (h) For the delicensure of beds, upon 30 days' written |
650 | notice to the agency. A request for exemption submitted under |
651 | this paragraph must identify the number, the category of beds, |
652 | and the name of the facility in which the beds to be delicensed |
653 | are located. |
654 | (e)(i) For the provision of adult inpatient diagnostic |
655 | cardiac catheterization services in a hospital. |
656 | 1. In addition to any other documentation otherwise |
657 | required by the agency, a request for an exemption submitted |
658 | under this paragraph must comply with the following criteria: |
659 | a. The applicant must certify it will not provide |
660 | therapeutic cardiac catheterization pursuant to the grant of the |
661 | exemption. |
662 | b. The applicant must certify it will meet and |
663 | continuously maintain the minimum licensure requirements adopted |
664 | by the agency governing such programs under pursuant to |
665 | subparagraph 2. |
666 | c. The applicant must certify it will provide a minimum of |
667 | 2 percent of its services to charity and Medicaid patients. |
668 | 2. The agency shall adopt licensure requirements by rule |
669 | which govern the operation of adult inpatient diagnostic cardiac |
670 | catheterization programs established under pursuant to the |
671 | exemption provided in this paragraph. The rules shall ensure |
672 | that the such programs: |
673 | a. Perform only adult inpatient diagnostic cardiac |
674 | catheterization services authorized by the exemption and will |
675 | not provide therapeutic cardiac catheterization or any other |
676 | services not authorized by the exemption. |
677 | b. Maintain sufficient appropriate equipment and health |
678 | personnel to ensure quality and safety. |
679 | c. Maintain appropriate times of operation and protocols |
680 | to ensure availability and appropriate referrals in the event of |
681 | emergencies. |
682 | d. Maintain appropriate program volumes to ensure quality |
683 | and safety. |
684 | e. Provide a minimum of 2 percent of its services to |
685 | charity and Medicaid patients each year. |
686 | 3.a. The exemption provided by this paragraph shall not |
687 | apply unless the agency determines that the program is in |
688 | compliance with the requirements of subparagraph 1. and that the |
689 | program will, after beginning operation, continuously comply |
690 | with the rules adopted under pursuant to subparagraph 2. The |
691 | agency shall monitor the such programs to ensure compliance with |
692 | the requirements of subparagraph 2. |
693 | b.(I) The exemption for a program expires shall expire |
694 | immediately when the program fails to comply with the rules |
695 | adopted under pursuant to sub-subparagraphs 2.a., b., and c. |
696 | (II) Beginning 18 months after a program first begins |
697 | treating patients, the exemption for a program expires shall |
698 | expire when the program fails to comply with the rules adopted |
699 | under pursuant to sub-subparagraphs 2.d. and e. |
700 | (III) If the exemption for a program expires under |
701 | pursuant to sub-sub-subparagraph (I) or sub-sub-subparagraph |
702 | (II), the agency may shall not grant an exemption under pursuant |
703 | to this paragraph for an adult inpatient diagnostic cardiac |
704 | catheterization program located at the same hospital until 2 |
705 | years following the date of the determination by the agency that |
706 | the program failed to comply with the rules adopted under |
707 | pursuant to subparagraph 2. |
708 | (f)(j) For mobile surgical facilities and related health |
709 | care services provided under contract with the Department of |
710 | Corrections or a private correctional facility operating under |
711 | pursuant to chapter 957. |
712 | (g)(k) For state veterans' nursing homes operated by or on |
713 | behalf of the Florida Department of Veterans' Affairs in |
714 | accordance with part II of chapter 296 for which at least 50 |
715 | percent of the construction cost is federally funded and for |
716 | which the Federal Government pays a per diem rate not to exceed |
717 | one-half of the cost of the veterans' care in the such state |
718 | nursing homes. These beds shall not be included in the nursing |
719 | home bed inventory. |
720 | (h)(l) For combination within one nursing home facility of |
721 | the beds or services authorized by two or more certificates of |
722 | need issued in the same planning subdistrict. An exemption |
723 | granted under this paragraph shall extend the validity period of |
724 | the certificates of need to be consolidated by the length of the |
725 | period beginning upon submission of the exemption request and |
726 | ending with issuance of the exemption. The longest validity |
727 | period among the certificates shall be applicable to each of the |
728 | combined certificates. |
729 | (i)(m) For division into two or more nursing home |
730 | facilities of beds or services authorized by one certificate of |
731 | need issued in the same planning subdistrict. An exemption |
732 | granted under this paragraph shall extend the validity period of |
733 | the certificate of need to be divided by the length of the |
734 | period beginning upon submission of the exemption request and |
735 | ending with issuance of the exemption. |
736 | (n) For the addition of hospital beds licensed under |
737 | chapter 395 for acute care, mental health services, or a |
738 | hospital-based distinct part skilled nursing unit in a number |
739 | that may not exceed 10 total beds or 10 percent of the licensed |
740 | capacity of the bed category being expanded, whichever is |
741 | greater. Beds for specialty burn units, neonatal intensive care |
742 | units, or comprehensive rehabilitation, or at a long-term care |
743 | hospital, may not be increased under this paragraph. |
744 | 1. In addition to any other documentation otherwise |
745 | required by the agency, a request for exemption submitted under |
746 | this paragraph must: |
747 | a. Certify that the prior 12-month average occupancy rate |
748 | for the category of licensed beds being expanded at the facility |
749 | meets or exceeds 80 percent or, for a hospital-based distinct |
750 | part skilled nursing unit, the prior 12-month average occupancy |
751 | rate meets or exceeds 96 percent. |
752 | b. Certify that any beds of the same type authorized for |
753 | the facility under this paragraph before the date of the current |
754 | request for an exemption have been licensed and operational for |
755 | at least 12 months. |
756 | 2. The timeframes and monitoring process specified in s. |
757 | 408.040(2)(a)-(c) apply to any exemption issued under this |
758 | paragraph. |
759 | 3. The agency shall count beds authorized under this |
760 | paragraph as approved beds in the published inventory of |
761 | hospital beds until the beds are licensed. |
762 | (o) For the addition of acute care beds, as authorized by |
763 | rule consistent with s. 395.003(4), in a number that may not |
764 | exceed 10 total beds or 10 percent of licensed bed capacity, |
765 | whichever is greater, for temporary beds in a hospital that has |
766 | experienced high seasonal occupancy within the prior 12-month |
767 | period or in a hospital that must respond to emergency |
768 | circumstances. |
769 | (j)(p) For the addition of nursing home beds licensed |
770 | under chapter 400 in a number not exceeding 10 total beds or 10 |
771 | percent of the number of beds licensed in the facility being |
772 | expanded, whichever is greater. |
773 | 1. In addition to any other documentation required by the |
774 | agency, a request for exemption submitted under this paragraph |
775 | must: |
776 | a. Effective until June 30, 2001, certify that the |
777 | facility has not had any class I or class II deficiencies within |
778 | the 30 months preceding the request for addition. |
779 | b. Effective on July 1, 2001, certify that the facility |
780 | has been designated as a Gold Seal nursing home under s. |
781 | 400.235. |
782 | c. Certify that the prior 12-month average occupancy rate |
783 | for the nursing home beds at the facility meets or exceeds 96 |
784 | percent. |
785 | d. Certify that any beds authorized for the facility under |
786 | this paragraph before the date of the current request for an |
787 | exemption have been licensed and operational for at least 12 |
788 | months. |
789 | 2. The timeframes and monitoring process specified in s. |
790 | 408.040(2)(a)-(c) apply to any exemption issued under this |
791 | paragraph. |
792 | 3. The agency shall count beds authorized under this |
793 | paragraph as approved beds in the published inventory of nursing |
794 | home beds until the beds are licensed. |
795 | (k) For establishing a Level II neonatal intensive care |
796 | unit with at least 10 beds, upon documentation to the agency |
797 | that the applicant hospital had a minimum of 1,500 births during |
798 | the previous 12 months, or establishing a Level III neonatal |
799 | intensive care unit with at least 15 beds, upon documentation to |
800 | the agency that the applicant hospital has a Level II neonatal |
801 | intensive care unit of at least 10 beds and had a minimum of |
802 | 3,500 births during the previous 12 months, if the applicant |
803 | commits to providing services to Medicaid and charity care |
804 | patients at a level equal to or greater than the district |
805 | average. This commitment is subject to s. 408.040. |
806 | (l) For adding comprehensive medical rehabilitation or |
807 | mental health services or beds, if the applicant commits to |
808 | providing services to Medicaid or charity care patients at a |
809 | level equal to or greater than the district average. This |
810 | commitment is subject to s. 408.040. |
811 | (q) For establishment of a specialty hospital offering a |
812 | range of medical service restricted to a defined age or gender |
813 | group of the population or a restricted range of services |
814 | appropriate to the diagnosis, care, and treatment of patients |
815 | with specific categories of medical illnesses or disorders, |
816 | through the transfer of beds and services from an existing |
817 | hospital in the same county. |
818 | (r) For the conversion of hospital-based Medicare and |
819 | Medicaid certified skilled nursing beds to acute care beds, if |
820 | the conversion does not involve the construction of new |
821 | facilities. |
822 | (s)1. For an adult open-heart-surgery program to be |
823 | located in a new hospital provided the new hospital is being |
824 | established in the location of an existing hospital with an |
825 | adult open-heart-surgery program, the existing hospital and the |
826 | existing adult open-heart-surgery program are being relocated to |
827 | a replacement hospital, and the replacement hospital will |
828 | utilize a closed-staff model. A hospital is exempt from the |
829 | certificate-of-need review for the establishment of an open- |
830 | heart-surgery program if the application for exemption submitted |
831 | under this paragraph complies with the following criteria: |
832 | a. The applicant must certify that it will meet and |
833 | continuously maintain the minimum Florida Administrative Code |
834 | and any future licensure requirements governing adult open-heart |
835 | programs adopted by the agency, including the most current |
836 | guidelines of the American College of Cardiology and American |
837 | Heart Association Guidelines for Adult Open Heart Programs. |
838 | b. The applicant must certify that it will maintain |
839 | sufficient appropriate equipment and health personnel to ensure |
840 | quality and safety. |
841 | c. The applicant must certify that it will maintain |
842 | appropriate times of operation and protocols to ensure |
843 | availability and appropriate referrals in the event of |
844 | emergencies. |
845 | d. The applicant is a newly licensed hospital in a |
846 | physical location previously owned and licensed to a hospital |
847 | performing more than 300 open-heart procedures each year, |
848 | including heart transplants. |
849 | e. The applicant must certify that it can perform more |
850 | than 300 diagnostic cardiac catheterization procedures per year, |
851 | combined inpatient and outpatient, by the end of the third year |
852 | of its operation. |
853 | f. The applicant's payor mix at a minimum reflects the |
854 | community average for Medicaid, charity care, and self-pay |
855 | patients or the applicant must certify that it will provide a |
856 | minimum of 5 percent of Medicaid, charity care, and self-pay to |
857 | open-heart-surgery patients. |
858 | g. If the applicant fails to meet the established criteria |
859 | for open-heart programs or fails to reach 300 surgeries per year |
860 | by the end of its third year of operation, it must show cause |
861 | why its exemption should not be revoked. |
862 | h. In order to ensure continuity of available services, |
863 | the applicant of the newly licensed hospital may apply for this |
864 | certificate-of-need before taking possession of the physical |
865 | facilities. The effective date of the certificate-of-need will |
866 | be concurrent with the effective date of the newly issued |
867 | hospital license. |
868 | 2. By December 31, 2004, and annually thereafter, the |
869 | agency shall submit a report to the Legislature providing |
870 | information concerning the number of requests for exemption |
871 | received under this paragraph and the number of exemptions |
872 | granted or denied. |
873 | 3. This paragraph is repealed effective January 1, 2008. |
874 | (t)1. For the provision of adult open-heart services in a |
875 | hospital located within the boundaries of Palm Beach, Polk, |
876 | Martin, St. Lucie, and Indian River Counties if the following |
877 | conditions are met: The exemption must be based upon objective |
878 | criteria and address and solve the twin problems of geographic |
879 | and temporal access. A hospital shall be exempt from the |
880 | certificate-of-need review for the establishment of an open- |
881 | heart-surgery program when the application for exemption |
882 | submitted under this paragraph complies with the following |
883 | criteria: |
884 | a. The applicant must certify that it will meet and |
885 | continuously maintain the minimum licensure requirements adopted |
886 | by the agency governing adult open-heart programs, including the |
887 | most current guidelines of the American College of Cardiology |
888 | and American Heart Association Guidelines for Adult Open Heart |
889 | Programs. |
890 | b. The applicant must certify that it will maintain |
891 | sufficient appropriate equipment and health personnel to ensure |
892 | quality and safety. |
893 | c. The applicant must certify that it will maintain |
894 | appropriate times of operation and protocols to ensure |
895 | availability and appropriate referrals in the event of |
896 | emergencies. |
897 | d. The applicant can demonstrate that it is referring 300 |
898 | or more patients per year from the hospital, including the |
899 | emergency room, for cardiac services at a hospital with cardiac |
900 | services, or that the average wait for transfer for 50 percent |
901 | or more of the cardiac patients exceeds 4 hours. |
902 | e. The applicant is a general acute care hospital that is |
903 | in operation for 3 years or more. |
904 | f. The applicant is performing more than 300 diagnostic |
905 | cardiac catheterization procedures per year, combined inpatient |
906 | and outpatient. |
907 | g. The applicant's payor mix at a minimum reflects the |
908 | community average for Medicaid, charity care, and self-pay |
909 | patients or the applicant must certify that it will provide a |
910 | minimum of 5 percent of Medicaid, charity care, and self-pay to |
911 | open-heart-surgery patients. |
912 | h. If the applicant fails to meet the established criteria |
913 | for open-heart programs or fails to reach 300 surgeries per year |
914 | by the end of its third year of operation, it must show cause |
915 | why its exemption should not be revoked. |
916 | 2. By December 31, 2004, and annually thereafter, the |
917 | Agency for Health Care Administration shall submit a report to |
918 | the Legislature providing information concerning the number of |
919 | requests for exemption received under this paragraph and the |
920 | number of exemptions granted or denied. |
921 | (4) A request for exemption under subsection (3) may be |
922 | made at any time and is not subject to the batching requirements |
923 | of this section. The request shall be supported by such |
924 | documentation as the agency requires by rule. The agency shall |
925 | assess a fee of $250 for each request for exemption submitted |
926 | under subsection (3). |
927 | (5) NOTIFICATION.--Health care facilities and providers |
928 | must notify the agency of the following: |
929 | (a) Replacement of a health care facility when the |
930 | proposed project site is located in the same district and on the |
931 | existing health care facility site or within a 1-mile radius of |
932 | the replaced health care facility, if the number and type of |
933 | beds do not increase. |
934 | (b) The termination of a health care service, upon 30 |
935 | days' written notice to the agency. |
936 | (c) The addition or delicensure of beds. |
937 |
|
938 | Notification under this subsection may be made at any time |
939 | before the action described, by electronic, facsimile, or |
940 | written means. |
941 | Section 7. Section 408.0361, Florida Statutes, is amended |
942 | to read: |
943 | 408.0361 Diagnostic cardiac catheterization services |
944 | providers; compliance with guidelines and requirements.-- |
945 | (1) Each provider of diagnostic cardiac catheterization |
946 | services shall comply with the requirements of s. |
947 | 408.036(3)(e)2.a.-d. s. 408.036(3)(i)2.a.-d., and rules of the |
948 | agency for Health Care Administration governing the operation of |
949 | adult inpatient diagnostic cardiac catheterization programs, |
950 | including the most recent guidelines of the American College of |
951 | Cardiology and American Heart Association Guidelines for Cardiac |
952 | Catheterization and Cardiac Catheterization Laboratories. |
953 | (2) The agency shall adopt rules for licensure standards |
954 | for adult interventional cardiology services and burn units |
955 | licensed under chapter 395. The rules shall consider at a |
956 | minimum: |
957 | (a) Staffing; |
958 | (b) Equipment; |
959 | (c) Physical plant; |
960 | (d) Operating protocols; |
961 | (e) Provision of services to Medicaid and charity care |
962 | patients; |
963 | (f) Accreditation; |
964 | (g) Licensure period; |
965 | (h) Fees; and |
966 | (i) Enforcement of minimum standards. |
967 |
|
968 | Any provider holding a certificate of need on July 1, 2004, and |
969 | any provider in receipt of a notice of intent to grant a |
970 | certificate of need or a final order of the agency granting a |
971 | certificate of need for an adult interventional cardiology |
972 | service or burn unit shall be exempt from complying with the |
973 | rules for 2 years following the date of its next license |
974 | renewal. Thereafter, each provider must meet the licensure |
975 | standards for each license renewal. |
976 | (3) When adopting rules for adult interventional |
977 | cardiology services, the agency shall include rules that allow |
978 | for: |
979 | (a) The establishment of two hospital program licensure |
980 | levels: a Level I program authorizing the performance of adult |
981 | percutaneous cardiac intervention without on-site cardiac |
982 | surgery and a Level II program authorizing the performance of |
983 | percutaneous cardiac intervention with on-site cardiac surgery. |
984 | (b) A hospital seeking a Level I program, demonstration |
985 | that for the most recent 12-month period as reported to the |
986 | agency it has provided a minimum of 300 adult inpatient and |
987 | outpatient diagnostic cardiac catheterizations and that it has a |
988 | formalized, written transfer agreement with a hospital that has |
989 | a Level II program, including written transport protocols to |
990 | ensure safe and efficient transfer of a patient within 60 |
991 | minutes. |
992 | (c) A hospital seeking a Level II program, demonstration |
993 | that for the most recent 12-month period as reported to the |
994 | agency that it has performed a minimum of 1,100 adult inpatient |
995 | and outpatient diagnostic cardiac catheterizations, or has |
996 | discharged at least 800 patients with the primary diagnosis of |
997 | ischemic heart disease. |
998 | (d) A demonstration of sufficient trained staff, |
999 | equipment, and operating procedures to assure patient quality |
1000 | and safety. |
1001 | (e) The establishment of appropriate hours of operation |
1002 | and protocols to ensure availability and timely referral in the |
1003 | event of emergencies. |
1004 | (f) A demonstration of a plan to provide services to |
1005 | Medicaid and charity care patients. |
1006 | (4) After a hospital's cardiac interventional program has |
1007 | been operational for 12 consecutive months, and the risk- |
1008 | adjusted mortality for coronary bypass surgery for any |
1009 | successive 12-month period exceeds, by more than 1.75 times, the |
1010 | national risk-adjusted mortality rate for coronary bypass |
1011 | surgery, as reported to the American Society of Thoracic |
1012 | Surgeons, in the first 2 years of operation of the hospital's |
1013 | Level II program, or by more than 1.25 times the national risk |
1014 | adjusted mortality rate for coronary bypass surgery, as reported |
1015 | by the American Society of Thoracic Surgeons, in any successive |
1016 | 12-month period after the second year of operation, the hospital |
1017 | shall perform a 30-day focused review of its Level II program |
1018 | with the intention of reducing the risk-adjusted mortality rate |
1019 | to reasonably acceptable levels. If mortality levels do not |
1020 | return to reasonably acceptable levels, the agency may initiate |
1021 | action up to and including suspension or revocation of licensure |
1022 | of the Level II program. |
1023 | Section 8. The Secretary of Health Care Administration |
1024 | shall appoint an advisory group to study the issue of replacing |
1025 | certificate-of-need review of organ transplant programs |
1026 | operating under chapter 408, Florida Statutes, with licensure |
1027 | regulation of organ transplant programs under chapter 395, |
1028 | Florida Statutes. The advisory group must include three |
1029 | representatives of organ transplant providers, one |
1030 | representative of an organ procurement organization, one |
1031 | representative of the Division of Health Quality Assurance, one |
1032 | representative of the Medicaid program, and one organ transplant |
1033 | patient advocate. The advisory group shall, at a minimum, make |
1034 | recommendations regarding access to organs, delivery of services |
1035 | to Medicaid and charity care patients, staff training, and |
1036 | resource requirements for organ transplant programs in a report |
1037 | submitted to the Governor, the Secretary of Health Care |
1038 | Administration, and the Legislature by July 1, 2005. |
1039 | Section 9. Section 408.038, Florida Statutes, is amended |
1040 | to read: |
1041 | 408.038 Fees.--The agency shall assess fees on |
1042 | certificate-of-need applications. The Such fees shall be for |
1043 | the purpose of funding the functions of the local health |
1044 | councils and the activities of the agency and shall be allocated |
1045 | as provided in s. 408.033. The fee shall be determined as |
1046 | follows: |
1047 | (1) A minimum base fee of $10,000 $5,000. |
1048 | (2) In addition to the base fee of $10,000 $5,000, 0.015 |
1049 | of each dollar of proposed expenditure, except that a fee may |
1050 | not exceed $50,000 $22,000. |
1051 | Section 10. Section 408.039, Florida Statutes, is amended |
1052 | to read: |
1053 | 408.039 Review process.--The review process for |
1054 | certificates of need shall be as follows: |
1055 | (1) REVIEW CYCLES.--The agency by rule shall provide for |
1056 | applications to be submitted on a timetable or cycle basis; |
1057 | provide for review on a timely basis; and provide for all |
1058 | completed applications pertaining to similar types of services |
1059 | or facilities affecting the same service district to be |
1060 | considered in relation to each other no less often than annually |
1061 | two times a year. |
1062 | (2) LETTERS OF INTENT.-- |
1063 | (a) At least 30 days before prior to filing an |
1064 | application, a letter of intent shall be filed by the applicant |
1065 | with the agency, respecting the development of a proposal |
1066 | subject to review. No letter of intent is required for |
1067 | expedited projects as defined by rule by the agency. |
1068 | (b) The agency shall provide a mechanism by which |
1069 | applications may be filed to compete with proposals described in |
1070 | filed letters of intent. |
1071 | (c) Letters of intent must describe the proposal; specify |
1072 | the number of beds sought, if any; identify the services to be |
1073 | provided and the specific subdistrict location; and identify the |
1074 | applicant. |
1075 | (d) Within 21 days after filing a letter of intent, the |
1076 | agency shall publish notice of the filing of letters of intent |
1077 | in the Florida Administrative Weekly and notice that, if |
1078 | requested, a public hearing shall be held at the local level |
1079 | within 21 days after the application is deemed complete. Notices |
1080 | under this paragraph must contain due dates applicable to the |
1081 | cycle for filing applications and for requesting a hearing. |
1082 | (3) APPLICATION PROCESSING.-- |
1083 | (a) An applicant shall file an application with the |
1084 | agency, and shall furnish a copy of the application to the local |
1085 | health council and the agency. Within 15 days after the |
1086 | applicable application filing deadline established by agency |
1087 | rule, the staff of the agency shall determine if the application |
1088 | is complete. If the application is incomplete, the staff shall |
1089 | request specific information from the applicant necessary for |
1090 | the application to be complete; however, the staff may make only |
1091 | one such request. If the requested information is not filed with |
1092 | the agency within 21 days of the receipt of the staff's request, |
1093 | the application shall be deemed incomplete and deemed withdrawn |
1094 | from consideration. |
1095 | (b) Upon the request of any applicant or substantially |
1096 | affected person within 14 days after notice that an application |
1097 | has been filed, a public hearing may be held at the agency's |
1098 | discretion if the agency determines that a proposed project |
1099 | involves issues of great local public interest. The public |
1100 | hearing shall allow applicants and other interested parties |
1101 | reasonable time to present their positions and to present |
1102 | rebuttal information. A recorded verbatim record of the hearing |
1103 | shall be maintained. The public hearing shall be held at the |
1104 | local level within 21 days after the application is deemed |
1105 | complete. |
1106 | (4) STAFF RECOMMENDATIONS.-- |
1107 | (a) The agency's review of and final agency action on |
1108 | applications shall be in accordance with the district health |
1109 | plan, and statutory criteria, and the implementing |
1110 | administrative rules. In the application review process, the |
1111 | agency shall give a preference, as defined by rule of the |
1112 | agency, to an applicant that which proposes to develop a nursing |
1113 | home in a nursing home geographically underserved area. |
1114 | (b) Within 60 days after all the applications in a review |
1115 | cycle are determined to be complete, the agency shall issue its |
1116 | State Agency Action Report and Notice of Intent to grant a |
1117 | certificate of need for the project in its entirety, to grant a |
1118 | certificate of need for identifiable portions of the project, or |
1119 | to deny a certificate of need. The State Agency Action Report |
1120 | shall set forth in writing its findings of fact and |
1121 | determinations upon which its decision is based. If a finding of |
1122 | fact or determination by the agency is counter to the district |
1123 | health plan of the local health council, the agency shall |
1124 | provide in writing its reason for its findings, item by item, to |
1125 | the local health council. If the agency intends to grant a |
1126 | certificate of need, the State Agency Action Report or the |
1127 | Notice of Intent shall also include any conditions which the |
1128 | agency intends to attach to the certificate of need. The agency |
1129 | shall designate by rule a senior staff person, other than the |
1130 | person who issues the final order, to issue State Agency Action |
1131 | Reports and Notices of Intent. |
1132 | (c) The agency shall publish its proposed decision set |
1133 | forth in the Notice of Intent in the Florida Administrative |
1134 | Weekly within 14 days after the Notice of Intent is issued. |
1135 | (d) If no administrative hearing is requested under |
1136 | pursuant to subsection (5), the State Agency Action Report and |
1137 | the Notice of Intent shall become the final order of the agency. |
1138 | The agency shall provide a copy of the final order to the |
1139 | appropriate local health council. |
1140 | (5) ADMINISTRATIVE HEARINGS.-- |
1141 | (a) Within 21 days after publication of notice of the |
1142 | State Agency Action Report and Notice of Intent, any person |
1143 | authorized under paragraph (c) to participate in a hearing may |
1144 | file a request for an administrative hearing; failure to file a |
1145 | request for hearing within 21 days of publication of notice |
1146 | shall constitute a waiver of any right to a hearing and a waiver |
1147 | of the right to contest the final decision of the agency. A |
1148 | copy of the request for hearing shall be served on the |
1149 | applicant. |
1150 | (b) Hearings shall be held in Tallahassee unless the |
1151 | administrative law judge determines that changing the location |
1152 | will facilitate the proceedings. The agency shall assign |
1153 | proceedings requiring hearings to the Division of Administrative |
1154 | Hearings of the Department of Management Services within 10 days |
1155 | after the time has expired for requesting a hearing. Except |
1156 | upon unanimous consent of the parties or upon the granting by |
1157 | the administrative law judge of a motion of continuance, |
1158 | hearings shall commence within 60 days after the administrative |
1159 | law judge has been assigned. All parties, except the agency, |
1160 | shall bear their own expense of preparing a transcript. In any |
1161 | application for a certificate of need which is referred to the |
1162 | Division of Administrative Hearings for hearing, the |
1163 | administrative law judge shall complete and submit to the |
1164 | parties a recommended order as provided in ss. 120.569 and |
1165 | 120.57. The recommended order shall be issued within 30 days |
1166 | after the receipt of the proposed recommended orders or the |
1167 | deadline for submission of the such proposed recommended orders, |
1168 | whichever is earlier. The division shall adopt procedures for |
1169 | administrative hearings which shall maximize the use of |
1170 | stipulated facts and shall provide for the admission of prepared |
1171 | testimony. |
1172 | (c) In administrative proceedings challenging the issuance |
1173 | or denial of a certificate of need, only applicants considered |
1174 | by the agency in the same batching cycle are entitled to a |
1175 | comparative hearing on their applications. Existing health care |
1176 | facilities may initiate or intervene in an administrative |
1177 | hearing upon a showing that an established program will be |
1178 | substantially affected by the issuance of any certificate of |
1179 | need, whether reviewed under s. 408.036(1) or (2), to a |
1180 | competing proposed facility or program within the same district. |
1181 | (d) The applicant's failure to strictly comply with the |
1182 | requirements of s. 408.037(1) or paragraph (2)(c) is not cause |
1183 | for dismissal of the application, unless the failure to comply |
1184 | impairs the fairness of the proceeding or affects the |
1185 | correctness of the action taken by the agency. |
1186 | (e) The agency shall issue its final order within 45 days |
1187 | after receipt of the recommended order. If the agency fails to |
1188 | take action within this such time, or as otherwise agreed to by |
1189 | the applicant and the agency, the applicant may take appropriate |
1190 | legal action to compel the agency to act. When making a |
1191 | determination on an application for a certificate of need, the |
1192 | agency is specifically exempt from the time limitations provided |
1193 | in s. 120.60(1). |
1194 | (6) JUDICIAL REVIEW.-- |
1195 | (a) A party to an administrative hearing for an |
1196 | application for a certificate of need has the right, within not |
1197 | more than 30 days after the date of the final order, to seek |
1198 | judicial review in the District Court of Appeal under pursuant |
1199 | to s. 120.68. The agency shall be a party to this in any such |
1200 | proceeding. |
1201 | (b) In the such judicial review, the court shall affirm |
1202 | the final order of the agency, unless the decision is arbitrary, |
1203 | capricious, or not in compliance with ss. 408.031-408.045. |
1204 | (c) The court, in its discretion, may award reasonable |
1205 | attorney's fees and costs to the prevailing party if the court |
1206 | finds that there was a complete absence of a justiciable issue |
1207 | of law or fact raised by the losing party. |
1208 | Section 11. Section 408.040, Florida Statutes, is amended |
1209 | to read: |
1210 | 408.040 Conditions and monitoring.-- |
1211 | (1)(a) The agency may issue a certificate of need or an |
1212 | exemption predicated upon statements of intent expressed by an |
1213 | applicant in the application for a certificate of need or |
1214 | exemption. Any conditions imposed on a certificate of need or an |
1215 | exemption based on such statements of intent shall be stated on |
1216 | the face of the certificate of need or in the exemption |
1217 | approval. |
1218 | (b) The agency may consider, in addition to the other |
1219 | criteria specified in s. 408.035, a statement of intent by the |
1220 | applicant that a specified percentage of the annual patient days |
1221 | at the facility will be utilized by patients eligible for care |
1222 | under Title XIX of the Social Security Act. Any certificate of |
1223 | need issued to a nursing home in reliance upon an applicant's |
1224 | statements that a specified percentage of annual patient days |
1225 | will be utilized by residents eligible for care under Title XIX |
1226 | of the Social Security Act must include a statement that this |
1227 | such certification is a condition of issuance of the certificate |
1228 | of need. The certificate-of-need program shall notify the |
1229 | Medicaid program office and the Department of Elderly Affairs |
1230 | when it imposes conditions as authorized in this paragraph in an |
1231 | area in which a community diversion pilot project is |
1232 | implemented. |
1233 | (c) A certificateholder or exemption holder may apply to |
1234 | the agency for a modification of conditions imposed under |
1235 | paragraph (a) or paragraph (b). If the holder of a certificate |
1236 | of need or exemption demonstrates good cause why the certificate |
1237 | or exemption should be modified, the agency shall reissue the |
1238 | certificate of need or exemption with such modifications as may |
1239 | be appropriate. The agency shall by rule define the factors |
1240 | constituting good cause for modification. |
1241 | (d) If the holder of a certificate of need or certificate- |
1242 | of-need exemption fails to comply with a condition upon which |
1243 | the issuance of the certificate or exemption was predicated, the |
1244 | agency shall may assess an administrative fine against the |
1245 | certificateholder or exemption holder in an amount not to exceed |
1246 | $1,000 per failure per day. Failure to annually report |
1247 | compliance with any condition upon which the issuance of the |
1248 | certificate or exemption was predicated constitutes |
1249 | noncompliance. In assessing the penalty, the agency shall take |
1250 | into account as mitigation the degree of noncompliance relative |
1251 | lack of severity of a particular failure. Proceeds of such |
1252 | penalties shall be deposited in the Public Medical Assistance |
1253 | Trust Fund. |
1254 | (2)(a) Unless the applicant has commenced construction, if |
1255 | the project provides for construction, unless the applicant has |
1256 | incurred an enforceable capital expenditure commitment for a |
1257 | project, if the project does not provide for construction, or |
1258 | unless subject to paragraph (b), a certificate of need shall |
1259 | terminate 18 months after the date of issuance. The agency shall |
1260 | monitor the progress of the holder of the certificate of need in |
1261 | meeting the timetable for project development specified in the |
1262 | application with the assistance of the local health council as |
1263 | specified in s. 408.033(1)(b)5., and may revoke the certificate |
1264 | of need, if the holder of the certificate is not meeting such |
1265 | timetable and is not making a good-faith effort, as defined by |
1266 | rule, to meet it. |
1267 | (b) A certificate of need issued to an applicant holding a |
1268 | provisional certificate of authority under chapter 651 shall |
1269 | terminate 1 year after the applicant receives a valid |
1270 | certificate of authority from the Office of Insurance Regulation |
1271 | of the Financial Services Commission. |
1272 | (c) The certificate-of-need validity period for a project |
1273 | shall be extended by the agency, to the extent that the |
1274 | applicant demonstrates to the satisfaction of the agency that |
1275 | good-faith commencement of the project is being delayed by |
1276 | litigation or by governmental action or inaction with respect to |
1277 | regulations or permitting precluding commencement of the |
1278 | project. |
1279 | (3) The agency shall require the submission of an executed |
1280 | architect's certification of final payment for each certificate- |
1281 | of-need project approved by the agency. Each project that |
1282 | involves construction shall submit such certification to the |
1283 | agency within 30 days following completion of construction. |
1284 | Section 12. Section 408.0455, Florida Statutes, is amended |
1285 | to read: |
1286 | 408.0455 Rules; pending proceedings.--The rules of the |
1287 | agency in effect on June 30, 2004 1997, shall remain in effect |
1288 | and shall be enforceable by the agency with respect to ss. |
1289 | 408.031-408.045 until the such rules are repealed or amended by |
1290 | the agency, and no judicial or administrative proceeding pending |
1291 | on July 1, 1997, shall be abated as a result of the provisions |
1292 | of ss. 408.031-408.043(1) and (2); s. 408.044; or s. 408.045. |
1293 | Section 13. Subsection (2) of section 408.043, and section |
1294 | 408.045, Florida Statutes, are repealed. |
1295 | Section 14. This act shall take effect July 1, 2004. |