Florida Senate - 2012 COMMITTEE AMENDMENT
Bill No. CS for SB 1884
Barcode 112214
LEGISLATIVE ACTION
Senate . House
Comm: WD .
03/01/2012 .
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The Committee on Budget Subcommittee on Health and Human
Services Appropriations (Garcia) recommended the following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Subsection (1) of section 83.42, Florida
6 Statutes, is amended to read:
7 83.42 Exclusions from application of part.—This part does
8 not apply to:
9 (1) Residency or detention in a facility, whether public or
10 private, when residence or detention is incidental to the
11 provision of medical, geriatric, educational, counseling,
12 religious, or similar services. For residents of a facility
13 licensed under part II of chapter 400, the provisions of s.
14 400.0255 are the exclusive procedures for all transfers and
15 discharges.
16 Section 2. Present paragraphs (f) through (k) of subsection
17 (10) of section 112.0455, Florida Statutes, are redesignated as
18 paragraphs (e) through (j), respectively, and present paragraph
19 (e) of subsection (10), subsection (12), and paragraph (e) of
20 subsection (14) of that section are amended to read:
21 112.0455 Drug-Free Workplace Act.—
22 (10) EMPLOYER PROTECTION.—
23 (e) Nothing in this section shall be construed to operate
24 retroactively, and nothing in this section shall abrogate the
25 right of an employer under state law to conduct drug tests prior
26 to January 1, 1990. A drug test conducted by an employer prior
27 to January 1, 1990, is not subject to this section.
28 (12) DRUG-TESTING STANDARDS; LABORATORIES.—
29 (a) The requirements of part II of chapter 408 apply to the
30 provision of services that require licensure pursuant to this
31 section and part II of chapter 408 and to entities licensed by
32 or applying for such licensure from the Agency for Health Care
33 Administration pursuant to this section. A license issued by the
34 agency is required in order to operate a laboratory.
35 (b) A laboratory may analyze initial or confirmation drug
36 specimens only if:
37 1. The laboratory is licensed and approved by the Agency
38 for Health Care Administration using criteria established by the
39 United States Department of Health and Human Services as general
40 guidelines for modeling the state drug testing program and in
41 accordance with part II of chapter 408. Each applicant for
42 licensure and licensee must comply with all requirements of part
43 II of chapter 408.
44 2. The laboratory has written procedures to ensure chain of
45 custody.
46 3. The laboratory follows proper quality control
47 procedures, including, but not limited to:
48 a. The use of internal quality controls including the use
49 of samples of known concentrations which are used to check the
50 performance and calibration of testing equipment, and periodic
51 use of blind samples for overall accuracy.
52 b. An internal review and certification process for drug
53 test results, conducted by a person qualified to perform that
54 function in the testing laboratory.
55 c. Security measures implemented by the testing laboratory
56 to preclude adulteration of specimens and drug test results.
57 d. Other necessary and proper actions taken to ensure
58 reliable and accurate drug test results.
59 (c) A laboratory shall disclose to the employer a written
60 test result report within 7 working days after receipt of the
61 sample. All laboratory reports of a drug test result shall, at a
62 minimum, state:
63 1. The name and address of the laboratory which performed
64 the test and the positive identification of the person tested.
65 2. Positive results on confirmation tests only, or negative
66 results, as applicable.
67 3. A list of the drugs for which the drug analyses were
68 conducted.
69 4. The type of tests conducted for both initial and
70 confirmation tests and the minimum cutoff levels of the tests.
71 5. Any correlation between medication reported by the
72 employee or job applicant pursuant to subparagraph (8)(b)2. and
73 a positive confirmed drug test result.
74
75 A No report may not shall disclose the presence or absence of
76 any drug other than a specific drug and its metabolites listed
77 pursuant to this section.
78 (d) The laboratory shall submit to the Agency for Health
79 Care Administration a monthly report with statistical
80 information regarding the testing of employees and job
81 applicants. The reports shall include information on the methods
82 of analyses conducted, the drugs tested for, the number of
83 positive and negative results for both initial and confirmation
84 tests, and any other information deemed appropriate by the
85 Agency for Health Care Administration. No monthly report shall
86 identify specific employees or job applicants.
87 (d)(e) Laboratories shall provide technical assistance to
88 the employer, employee, or job applicant for the purpose of
89 interpreting any positive confirmed test results which could
90 have been caused by prescription or nonprescription medication
91 taken by the employee or job applicant.
92 (14) DISCIPLINE REMEDIES.—
93 (e) Upon resolving an appeal filed pursuant to paragraph
94 (c), and finding a violation of this section, the commission may
95 order the following relief:
96 1. Rescind the disciplinary action, expunge related records
97 from the personnel file of the employee or job applicant and
98 reinstate the employee.
99 2. Order compliance with paragraph (10)(f) (10)(g).
100 3. Award back pay and benefits.
101 4. Award the prevailing employee or job applicant the
102 necessary costs of the appeal, reasonable attorney’s fees, and
103 expert witness fees.
104 Section 3. Paragraph (n) of subsection (1) of section
105 154.11, Florida Statutes, is amended to read:
106 154.11 Powers of board of trustees.—
107 (1) The board of trustees of each public health trust shall
108 be deemed to exercise a public and essential governmental
109 function of both the state and the county and in furtherance
110 thereof it shall, subject to limitation by the governing body of
111 the county in which such board is located, have all of the
112 powers necessary or convenient to carry out the operation and
113 governance of designated health care facilities, including, but
114 without limiting the generality of, the foregoing:
115 (n) To appoint originally the staff of physicians to
116 practice in any designated facility owned or operated by the
117 board and to approve the bylaws and rules to be adopted by the
118 medical staff of any designated facility owned and operated by
119 the board, such governing regulations to be in accordance with
120 the standards of the Joint Commission on the Accreditation of
121 Hospitals which provide, among other things, for the method of
122 appointing additional staff members and for the removal of staff
123 members.
124 Section 4. Subsection (15) of section 318.21, Florida
125 Statutes, is amended to read:
126 318.21 Disposition of civil penalties by county courts.—All
127 civil penalties received by a county court pursuant to the
128 provisions of this chapter shall be distributed and paid monthly
129 as follows:
130 (15) Of the additional fine assessed under s. 318.18(3)(e)
131 for a violation of s. 316.1893, 50 percent of the moneys
132 received from the fines shall be remitted to the Department of
133 Revenue and deposited into the Brain and Spinal Cord Injury
134 Trust Fund of Department of Health and appropriated to the
135 Department of Health Agency for Health Care Administration as
136 general revenue to provide an enhanced Medicaid payment to
137 nursing homes that serve Medicaid recipients who have with brain
138 and spinal cord injuries that are medically complex and who are
139 technologically and respiratory dependent. The remaining 50
140 percent of the moneys received from the enhanced fine imposed
141 under s. 318.18(3)(e) shall be remitted to the Department of
142 Revenue and deposited into the Department of Health Emergency
143 Medical Services Trust Fund to provide financial support to
144 certified trauma centers in the counties where enhanced penalty
145 zones are established to ensure the availability and
146 accessibility of trauma services. Funds deposited into the
147 Emergency Medical Services Trust Fund under this subsection
148 shall be allocated as follows:
149 (a) Fifty percent shall be allocated equally among all
150 Level I, Level II, and pediatric trauma centers in recognition
151 of readiness costs for maintaining trauma services.
152 (b) Fifty percent shall be allocated among Level I, Level
153 II, and pediatric trauma centers based on each center’s relative
154 volume of trauma cases as reported in the Department of Health
155 Trauma Registry.
156 Section 5. Paragraph (g) of subsection (1) of section
157 383.011, Florida Statutes, is amended to read:
158 383.011 Administration of maternal and child health
159 programs.—
160 (1) The Department of Health is designated as the state
161 agency for:
162 (g) Receiving the federal funds for the “Special
163 Supplemental Nutrition Program for Women, Infants, and
164 Children,” or WIC, authorized by the Child Nutrition Act of
165 1966, as amended, and for providing clinical leadership for
166 administering the statewide WIC program.
167 1. The department shall establish an interagency agreement
168 with the Department of Children and Family Services for
169 management of the program. Responsibilities are delegated to
170 each department as follows:
171 a. The department shall provide clinical leadership, manage
172 program eligibility, and distribute nutritional guidance and
173 information to participants.
174 b. The Department of Children and Family Services shall
175 develop and implement an electronic benefits transfer system.
176 c. The Department of Children and Family Services shall
177 develop a cost containment plan that provides timely and
178 accurate adjustments based on wholesale price fluctuations and
179 adjusts for the number of cash registers in calculating
180 statewide averages.
181 d. The department shall coordinate submission of
182 information to appropriate federal officials in order to obtain
183 approval of the electronic benefits system and cost containment
184 plan, which must include the participation of WIC-only stores.
185 2. The department shall assist the Department of Children
186 and Family Services in the development of the electronic
187 benefits system to ensure full implementation no later than July
188 1, 2013.
189 Section 6. Section 383.325, Florida Statutes, is repealed.
190 Section 7. Section 385.2031, Florida Statutes, is created
191 to read:
192 385.2031 Resource for research in the prevention and
193 treatment of diabetes.—The Florida Hospital/Sanford-Burnham
194 Translational Research Institute for Metabolism and Diabetes is
195 designated as a resource in this state for research in the
196 prevention and treatment of diabetes.
197 Section 8. Subsection (7) of section 394.4787, Florida
198 Statutes, is amended to read:
199 394.4787 Definitions; ss. 394.4786, 394.4787, 394.4788, and
200 394.4789.—As used in this section and ss. 394.4786, 394.4788,
201 and 394.4789:
202 (7) “Specialty psychiatric hospital” means a hospital
203 licensed by the agency pursuant to s. 395.002(26) 395.002(28)
204 and part II of chapter 408 as a specialty psychiatric hospital.
205 Section 9. Subsection (2) of section 394.741, Florida
206 Statutes, is amended to read:
207 394.741 Accreditation requirements for providers of
208 behavioral health care services.—
209 (2) Notwithstanding any provision of law to the contrary,
210 accreditation shall be accepted by the agency and department in
211 lieu of the agency’s and department’s facility licensure onsite
212 review requirements and shall be accepted as a substitute for
213 the department’s administrative and program monitoring
214 requirements, except as required by subsections (3) and (4),
215 for:
216 (a) Any organization from which the department purchases
217 behavioral health care services that is accredited by the Joint
218 Commission on Accreditation of Healthcare Organizations or the
219 Council on Accreditation for Children and Family Services, or
220 has those services that are being purchased by the department
221 accredited by the Commission on Accreditation of Rehabilitation
222 Facilities CARF—the Rehabilitation Accreditation Commission.
223 (b) Any mental health facility licensed by the agency or
224 any substance abuse component licensed by the department that is
225 accredited by the Joint Commission on Accreditation of
226 Healthcare Organizations, the Commission on Accreditation of
227 Rehabilitation Facilities CARF—the Rehabilitation Accreditation
228 Commission, or the Council on Accreditation of Children and
229 Family Services.
230 (c) Any network of providers from which the department or
231 the agency purchases behavioral health care services accredited
232 by the Joint Commission on Accreditation of Healthcare
233 Organizations, the Commission on Accreditation of Rehabilitation
234 Facilities CARF—the Rehabilitation Accreditation Commission, the
235 Council on Accreditation of Children and Family Services, or the
236 National Committee for Quality Assurance. A provider
237 organization, which is part of an accredited network, is
238 afforded the same rights under this part.
239 Section 10. Present subsections (15) through (33) of
240 section 395.002, Florida Statutes, are redesignated as
241 subsections (14) through (30), respectively, and present
242 subsections (1), (14), (24), (28), and (31) of that section are
243 amended, to read:
244 395.002 Definitions.—As used in this chapter:
245 (1) “Accrediting organizations” means nationally recognized
246 or approved accrediting organizations whose standards
247 incorporate comparable licensure requirements as determined by
248 the agency the Joint Commission on Accreditation of Healthcare
249 Organizations, the American Osteopathic Association, the
250 Commission on Accreditation of Rehabilitation Facilities, and
251 the Accreditation Association for Ambulatory Health Care, Inc.
252 (14) “Initial denial determination” means a determination
253 by a private review agent that the health care services
254 furnished or proposed to be furnished to a patient are
255 inappropriate, not medically necessary, or not reasonable.
256 (24) “Private review agent” means any person or entity
257 which performs utilization review services for third-party
258 payors on a contractual basis for outpatient or inpatient
259 services. However, the term shall not include full-time
260 employees, personnel, or staff of health insurers, health
261 maintenance organizations, or hospitals, or wholly owned
262 subsidiaries thereof or affiliates under common ownership, when
263 performing utilization review for their respective hospitals,
264 health maintenance organizations, or insureds of the same
265 insurance group. For this purpose, health insurers, health
266 maintenance organizations, and hospitals, or wholly owned
267 subsidiaries thereof or affiliates under common ownership,
268 include such entities engaged as administrators of self
269 insurance as defined in s. 624.031.
270 (26)(28) “Specialty hospital” means any facility which
271 meets the provisions of subsection (12), and which regularly
272 makes available either:
273 (a) The range of medical services offered by general
274 hospitals, but restricted to a defined age or gender group of
275 the population;
276 (b) A restricted range of services appropriate to the
277 diagnosis, care, and treatment of patients with specific
278 categories of medical or psychiatric illnesses or disorders; or
279 (c) Intensive residential treatment programs for children
280 and adolescents as defined in subsection (14) (15).
281 (31) “Utilization review” means a system for reviewing the
282 medical necessity or appropriateness in the allocation of health
283 care resources of hospital services given or proposed to be
284 given to a patient or group of patients.
285 Section 11. Paragraph (c) of subsection (1) and paragraph
286 (b) of subsection (2) of section 395.003, Florida Statutes, are
287 amended to read:
288 395.003 Licensure; denial, suspension, and revocation.—
289 (1)
290 (c) Until July 1, 2006, additional emergency departments
291 located off the premises of licensed hospitals may not be
292 authorized by the agency.
293 (2)
294 (b) The agency shall, at the request of a licensee that is
295 a teaching hospital as defined in s. 408.07(45), issue a single
296 license to a licensee for facilities that have been previously
297 licensed as separate premises, provided such separately licensed
298 facilities, taken together, constitute the same premises as
299 defined in s. 395.002(22) 395.002(23). Such license for the
300 single premises shall include all of the beds, services, and
301 programs that were previously included on the licenses for the
302 separate premises. The granting of a single license under this
303 paragraph shall not in any manner reduce the number of beds,
304 services, or programs operated by the licensee.
305 Section 12. Subsection (3) of section 395.0161, Florida
306 Statutes, is amended to read:
307 395.0161 Licensure inspection.—
308 (3) In accordance with s. 408.805, an applicant or licensee
309 shall pay a fee for each license application submitted under
310 this part, part II of chapter 408, and applicable rules. With
311 the exception of state-operated licensed facilities, each
312 facility licensed under this part shall pay to the agency, at
313 the time of inspection, the following fees:
314 (a) Inspection for licensure.—A fee shall be paid which is
315 not less than $8 per hospital bed, nor more than $12 per
316 hospital bed, except that the minimum fee shall be $400 per
317 facility.
318 (b) Inspection for lifesafety only.—A fee shall be paid
319 which is not less than 75 cents per hospital bed, nor more than
320 $1.50 per hospital bed, except that the minimum fee shall be $40
321 per facility.
322 Section 13. Subsections (2) and (4) of section 395.0193,
323 Florida Statutes, are amended to read:
324 395.0193 Licensed facilities; peer review; disciplinary
325 powers; agency or partnership with physicians.—
326 (2) Each licensed facility, as a condition of licensure,
327 shall provide for peer review of physicians who deliver health
328 care services at the facility. Each licensed facility shall
329 develop written, binding procedures by which such peer review
330 shall be conducted. Such procedures must shall include:
331 (a) Mechanism for choosing the membership of the body or
332 bodies that conduct peer review.
333 (b) Adoption of rules of order for the peer review process.
334 (c) Fair review of the case with the physician involved.
335 (d) Mechanism to identify and avoid conflict of interest on
336 the part of the peer review panel members.
337 (e) Recording of agendas and minutes which do not contain
338 confidential material, for review by the Division of Medical
339 Quality Assurance of the department Health Quality Assurance of
340 the agency.
341 (f) Review, at least annually, of the peer review
342 procedures by the governing board of the licensed facility.
343 (g) Focus of the peer review process on review of
344 professional practices at the facility to reduce morbidity and
345 mortality and to improve patient care.
346 (4) Pursuant to ss. 458.337 and 459.016, any disciplinary
347 actions taken under subsection (3) shall be reported in writing
348 to the Division of Medical Quality Assurance of the department
349 Health Quality Assurance of the agency within 30 working days
350 after its initial occurrence, regardless of the pendency of
351 appeals to the governing board of the hospital. The notification
352 shall identify the disciplined practitioner, the action taken,
353 and the reason for such action. All final disciplinary actions
354 taken under subsection (3), if different from those which were
355 reported to the department agency within 30 days after the
356 initial occurrence, shall be reported within 10 working days to
357 the Division of Medical Quality Assurance of the department
358 Health Quality Assurance of the agency in writing and shall
359 specify the disciplinary action taken and the specific grounds
360 therefor. The division shall review each report and determine
361 whether it potentially involved conduct by the licensee that is
362 subject to disciplinary action, in which case s. 456.073 shall
363 apply. The reports are not subject to inspection under s.
364 119.07(1) even if the division’s investigation results in a
365 finding of probable cause.
366 Section 14. Section 395.1023, Florida Statutes, is amended
367 to read:
368 395.1023 Child abuse and neglect cases; duties.—Each
369 licensed facility shall adopt a protocol that, at a minimum,
370 requires the facility to:
371 (1) Incorporate a facility policy that every staff member
372 has an affirmative duty to report, pursuant to chapter 39, any
373 actual or suspected case of child abuse, abandonment, or
374 neglect; and
375 (2) In any case involving suspected child abuse,
376 abandonment, or neglect, designate, at the request of the
377 Department of Children and Family Services, a staff physician to
378 act as a liaison between the hospital and the Department of
379 Children and Family Services office which is investigating the
380 suspected abuse, abandonment, or neglect, and the child
381 protection team, as defined in s. 39.01, when the case is
382 referred to such a team.
383
384 Each general hospital and appropriate specialty hospital shall
385 comply with the provisions of this section and shall notify the
386 agency and the Department of Children and Family Services of its
387 compliance by sending a copy of its policy to the agency and the
388 Department of Children and Family Services as required by rule.
389 The failure by a general hospital or appropriate specialty
390 hospital to comply shall be punished by a fine not exceeding
391 $1,000, to be fixed, imposed, and collected by the agency. Each
392 day in violation is considered a separate offense.
393 Section 15. Subsection (2) and paragraph (d) of subsection
394 (3) of section 395.1041, Florida Statutes, are amended to read:
395 395.1041 Access to emergency services and care.—
396 (2) INVENTORY OF HOSPITAL EMERGENCY SERVICES.—The agency
397 shall establish and maintain an inventory of hospitals with
398 emergency services. The inventory shall list all services within
399 the service capability of the hospital, and such services shall
400 appear on the face of the hospital license. Each hospital having
401 emergency services shall notify the agency of its service
402 capability in the manner and form prescribed by the agency. The
403 agency shall use the inventory to assist emergency medical
404 services providers and others in locating appropriate emergency
405 medical care. The inventory shall also be made available to the
406 general public. On or before August 1, 1992, the agency shall
407 request that each hospital identify the services which are
408 within its service capability. On or before November 1, 1992,
409 the agency shall notify each hospital of the service capability
410 to be included in the inventory. The hospital has 15 days from
411 the date of receipt to respond to the notice. By December 1,
412 1992, the agency shall publish a final inventory. Each hospital
413 shall reaffirm its service capability when its license is
414 renewed and shall notify the agency of the addition of a new
415 service or the termination of a service prior to a change in its
416 service capability.
417 (3) EMERGENCY SERVICES; DISCRIMINATION; LIABILITY OF
418 FACILITY OR HEALTH CARE PERSONNEL.—
419 (d)1. Every hospital shall ensure the provision of services
420 within the service capability of the hospital, at all times,
421 either directly or indirectly through an arrangement with
422 another hospital, through an arrangement with one or more
423 physicians, or as otherwise made through prior arrangements. A
424 hospital may enter into an agreement with another hospital for
425 purposes of meeting its service capability requirement, and
426 appropriate compensation or other reasonable conditions may be
427 negotiated for these backup services.
428 2. If any arrangement requires the provision of emergency
429 medical transportation, such arrangement must be made in
430 consultation with the applicable provider and may not require
431 the emergency medical service provider to provide transportation
432 that is outside the routine service area of that provider or in
433 a manner that impairs the ability of the emergency medical
434 service provider to timely respond to prehospital emergency
435 calls.
436 3. A hospital is shall not be required to ensure service
437 capability at all times as required in subparagraph 1. if, prior
438 to the receiving of any patient needing such service capability,
439 such hospital has demonstrated to the agency that it lacks the
440 ability to ensure such capability and it has exhausted all
441 reasonable efforts to ensure such capability through backup
442 arrangements. In reviewing a hospital’s demonstration of lack of
443 ability to ensure service capability, the agency shall consider
444 factors relevant to the particular case, including the
445 following:
446 a. Number and proximity of hospitals with the same service
447 capability.
448 b. Number, type, credentials, and privileges of
449 specialists.
450 c. Frequency of procedures.
451 d. Size of hospital.
452 4. The agency shall publish proposed rules implementing a
453 reasonable exemption procedure by November 1, 1992. Subparagraph
454 1. shall become effective upon the effective date of said rules
455 or January 31, 1993, whichever is earlier. For a period not to
456 exceed 1 year from the effective date of subparagraph 1., a
457 hospital requesting an exemption shall be deemed to be exempt
458 from offering the service until the agency initially acts to
459 deny or grant the original request. The agency has 45 days after
460 from the date of receipt of the request to approve or deny the
461 request. After the first year from the effective date of
462 subparagraph 1., If the agency fails to initially act within
463 that the time period, the hospital is deemed to be exempt from
464 offering the service until the agency initially acts to deny the
465 request.
466 Section 16. Section 395.1046, Florida Statutes, is
467 repealed.
468 Section 17. Paragraphs (b) and (e) of subsection (1) of
469 section 395.1055, Florida Statutes, are amended to read:
470 395.1055 Rules and enforcement.—
471 (1) The agency shall adopt rules pursuant to ss. 120.536(1)
472 and 120.54 to implement the provisions of this part, which shall
473 include reasonable and fair minimum standards for ensuring that:
474 (b) Infection control, housekeeping, sanitary conditions,
475 and medical record procedures that will adequately protect
476 patient care and safety are established and implemented. These
477 procedures shall require housekeeping and sanitation staff to
478 wear masks and gloves when cleaning patient rooms, to disinfect
479 environmental surfaces in patient rooms in accordance with the
480 time instructions on the label of the disinfectant used by the
481 hospital, and to document compliance. The agency may impose an
482 administrative fine for each day that a violation of this
483 paragraph occurs.
484 (e) Licensed facility beds conform to minimum space,
485 equipment, and furnishings standards as specified by the agency,
486 the Florida Building Code, and the Florida Fire Prevention Code
487 department.
488 Section 18. Paragraph (e) of subsection (4) of section
489 395.3025, Florida Statutes, is amended to read:
490 395.3025 Patient and personnel records; copies;
491 examination.—
492 (4) Patient records are confidential and must not be
493 disclosed without the consent of the patient or his or her legal
494 representative, but appropriate disclosure may be made without
495 such consent to:
496 (e) The department agency upon subpoena issued pursuant to
497 s. 456.071., but The records obtained thereby must be used
498 solely for the purpose of the agency, the department, and the
499 appropriate professional board in an its investigation,
500 prosecution, and appeal of disciplinary proceedings. If the
501 department agency requests copies of the records, the facility
502 shall charge a fee pursuant to this section no more than its
503 actual copying costs, including reasonable staff time. The
504 records must be sealed and must not be available to the public
505 pursuant to s. 119.07(1) or any other statute providing access
506 to records, nor may they be available to the public as part of
507 the record of investigation for and prosecution in disciplinary
508 proceedings made available to the public by the agency, the
509 department, or the appropriate regulatory board. However, the
510 department agency must make available, upon written request by a
511 practitioner against whom probable cause has been found, any
512 such records that form the basis of the determination of
513 probable cause.
514 Section 19. Subsection (2) of section 395.3036, Florida
515 Statutes, is amended to read:
516 395.3036 Confidentiality of records and meetings of
517 corporations that lease public hospitals or other public health
518 care facilities.—The records of a private corporation that
519 leases a public hospital or other public health care facility
520 are confidential and exempt from the provisions of s. 119.07(1)
521 and s. 24(a), Art. I of the State Constitution, and the meetings
522 of the governing board of a private corporation are exempt from
523 s. 286.011 and s. 24(b), Art. I of the State Constitution when
524 the public lessor complies with the public finance
525 accountability provisions of s. 155.40(5) with respect to the
526 transfer of any public funds to the private lessee and when the
527 private lessee meets at least three of the five following
528 criteria:
529 (2) The public lessor and the private lessee do not
530 commingle any of their funds in any account maintained by either
531 of them, other than the payment of the rent and administrative
532 fees or the transfer of funds pursuant to s. 155.40 subsection
533 (2).
534 Section 20. Section 395.3037, Florida Statutes, is
535 repealed.
536 Section 21. Paragraph (b) of subsection (1) of section
537 395.401, Florida Statutes, is amended to read:
538 395.401 Trauma services system plans; approval of trauma
539 centers and pediatric trauma centers; procedures; renewal.—
540 (1)
541 (b) The local and regional trauma agencies shall develop
542 and submit to the department plans for local and regional trauma
543 services systems. The plans must include, at a minimum, the
544 following components:
545 1. The organizational structure of the trauma system.
546 2. Prehospital care management guidelines for triage and
547 transportation of trauma cases.
548 3. Flow patterns of trauma cases and transportation system
549 design and resources, including air transportation services,
550 provision for interfacility trauma transfer, and the prehospital
551 transportation of trauma victims. The trauma agency shall plan
552 for the development of a system of transportation of trauma
553 alert victims to trauma centers where the distance or time to a
554 trauma center or transportation resources diminish access by
555 trauma alert victims.
556 4. The number and location of needed trauma centers based
557 on local needs, population, and location and distribution of
558 resources.
559 4.5. Data collection regarding system operation and patient
560 outcome.
561 5.6. Periodic performance evaluation of the trauma system
562 and its components.
563 6.7. The use of air transport services within the
564 jurisdiction of the local trauma agency.
565 7.8. Public information and education about the trauma
566 system.
567 8.9. Emergency medical services communication system usage
568 and dispatching.
569 9.10. The coordination and integration between the trauma
570 center and other acute care hospitals.
571 10.11. Medical control and accountability.
572 11.12. Quality control and system evaluation.
573 Section 22. Paragraphs (b) and (c) of subsection (4) of
574 section 395.402, Florida Statutes, are amended to read:
575 395.402 Trauma service areas; number and location of trauma
576 centers.—
577 (4) Annually thereafter, the department shall review the
578 assignment of the 67 counties to trauma service areas, in
579 addition to the requirements of paragraphs (2)(b)-(g) and
580 subsection (3). County assignments are made for the purpose of
581 developing a system of trauma centers. Revisions made by the
582 department shall take into consideration the recommendations
583 made as part of the regional trauma system plans approved by the
584 department and the recommendations made as part of the state
585 trauma system plan. In cases where a trauma service area is
586 located within the boundaries of more than one trauma region,
587 the trauma service area’s needs, response capability, and system
588 requirements shall be considered by each trauma region served by
589 that trauma service area in its regional system plan. Until the
590 department completes the February 2005 assessment, the
591 assignment of counties shall remain as established in this
592 section.
593 (b) Each trauma service area should have at least one Level
594 I or Level II trauma center. The department shall allocate, by
595 rule, the number of trauma centers needed for each trauma
596 service area.
597 (c) There shall be no more than a total of 44 trauma
598 centers in the state.
599 Section 23. Section 395.4025, Florida Statutes, is amended
600 to read:
601 395.4025 Trauma centers; selection; quality assurance;
602 records.—
603 (1) For purposes of developing a system of trauma centers,
604 the department shall use the 19 trauma service areas established
605 in s. 395.402. Within each service area and based on the state
606 trauma system plan, the local or regional trauma services system
607 plan, and recommendations of the local or regional trauma
608 agency, the department shall establish the approximate number of
609 trauma centers needed to ensure reasonable access to high
610 quality trauma services. The department shall select those
611 hospitals that are to be recognized as trauma centers.
612 (2)(a) The department shall annually notify each acute care
613 general hospital and each local and each regional trauma agency
614 in the state that the department is accepting letters of intent
615 from hospitals that are interested in becoming trauma centers.
616 In order to be considered by the department, a hospital that
617 operates within the geographic area of a local or regional
618 trauma agency must certify that its intent to operate as a
619 trauma center is consistent with the trauma services plan of the
620 local or regional trauma agency, as approved by the department,
621 if such agency exists. Letters of intent must be postmarked no
622 later than midnight October 1.
623 (b) By October 15, The department shall send to all
624 hospitals that submit submitted a letter of intent an
625 application package that will provide the hospitals with
626 instructions for submitting information to the department for
627 approval selection as a trauma center. These instructions shall
628 explain the specific documentation necessary for the department
629 to determine a hospital’s compliance with the clinical standards
630 and capabilities for a trauma center. The standards for trauma
631 centers provided for in s. 395.401(2), as adopted by rule of the
632 department, shall serve as the basis for these instructions.
633 (c) In order to be considered by The department, shall
634 approve applications from those hospitals seeking designation
635 selection as trauma centers, including those current verified
636 trauma centers that seek a change or redesignation in approval
637 status as a trauma center, provided the hospital documents
638 compliance with the clinical standards and capabilities of a
639 trauma center must be received by the department no later than
640 the close of business on April 1. The department shall conduct a
641 provisional review of each application for the purpose of
642 determining that the hospital’s application is complete and that
643 the hospital has the critical elements required for a trauma
644 center. This critical review will be based on trauma center
645 standards and shall include, but not be limited to, a review of
646 whether the hospital has:
647 1. Equipment and physical facilities necessary to provide
648 trauma services.
649 2. Personnel in sufficient numbers and with proper
650 qualifications to provide trauma services.
651 3. An effective quality assurance process.
652 4. Submitted written confirmation by the local or regional
653 trauma agency that the hospital applying to become a trauma
654 center is consistent with the plan of the local or regional
655 trauma agency, as approved by the department, if such agency
656 exists.
657 (d)1. Notwithstanding other provisions in this section, the
658 department may grant up to an additional 18 months to a hospital
659 applicant that is unable to meet all requirements as provided in
660 paragraph (c) at the time of application if the number of
661 applicants in the service area in which the applicant is located
662 is equal to or less than the service area allocation, as
663 provided by rule of the department. An applicant that is granted
664 additional time pursuant to this paragraph shall submit a plan
665 for departmental approval which includes timelines and
666 activities that the applicant proposes to complete in order to
667 meet application requirements. Any applicant that demonstrates
668 an ongoing effort to complete the activities within the
669 timelines outlined in the plan shall be included in the number
670 of trauma centers at such time that the department has conducted
671 a provisional review of the application and has determined that
672 the application is complete and that the hospital has the
673 critical elements required for a trauma center.
674 2. Timeframes provided in subsections (1)-(8) shall be
675 stayed until the department determines that the application is
676 complete and that the hospital has the critical elements
677 required for a trauma center.
678 (3) After April 30, Any hospital that submitted an
679 application found acceptable by the department based on
680 provisional review shall be eligible to operate as a provisional
681 trauma center.
682 (4) Between May 1 and October 1 of each year, The
683 department shall conduct an in-depth evaluation of all
684 applications found acceptable in the provisional review. The
685 applications shall be evaluated against clinical criteria
686 enumerated in the application packages as provided to the
687 hospitals by the department.
688 (5) Beginning October 1 of each year and ending no later
689 than June 1 of the following year, A review team of out-of-state
690 experts assembled by the department shall make onsite visits to
691 all provisional trauma centers. The department shall develop a
692 survey instrument to be used by the expert team of reviewers.
693 The instrument shall include objective criteria and guidelines
694 for reviewers based on existing trauma center standards such
695 that all trauma centers are assessed equally. The survey
696 instrument shall also include a uniform rating system that will
697 be used by reviewers to indicate the degree of compliance of
698 each trauma center with specific standards, and to indicate the
699 quality of care provided by each trauma center as determined
700 through an audit of patient charts. In addition, Hospitals being
701 considered as provisional trauma centers shall meet all the
702 requirements of a trauma center and shall be located in a trauma
703 service area that has a need for such a trauma center.
704 (6) Based on recommendations from the review team, the
705 department shall approve hospitals for designation as select
706 trauma centers by July 1. An applicant for designation as a
707 trauma center may request an extension of its provisional status
708 if it submits a corrective action plan to the department. The
709 corrective action plan must demonstrate the ability of the
710 applicant to correct deficiencies noted during the applicant’s
711 onsite review conducted by the department between the previous
712 October 1 and June 1. The department may extend the provisional
713 status of an applicant for designation as a trauma center
714 through December 31 if the applicant provides a corrective
715 action plan acceptable to the department. The department or a
716 team of out-of-state experts assembled by the department shall
717 conduct an onsite visit on or before November 1 to confirm that
718 the deficiencies have been corrected. The provisional trauma
719 center is responsible for all costs associated with the onsite
720 visit in a manner prescribed by rule of the department. By
721 January 1, the department must approve or deny the application
722 of any provisional applicant granted an extension. Each trauma
723 center shall be granted a 7-year approval period during which
724 time it must continue to maintain trauma center standards and
725 acceptable patient outcomes as determined by department rule. An
726 approval, unless sooner suspended or revoked, automatically
727 expires 7 years after the date of issuance and is renewable upon
728 application for renewal as prescribed by rule of the department.
729 (7) Any hospital that wishes to protest a decision made by
730 the department based on the department’s preliminary or in-depth
731 review of applications or on the recommendations of the site
732 visit review team pursuant to this section shall proceed as
733 provided in chapter 120. Hearings held under this subsection
734 shall be conducted in the same manner as provided in ss. 120.569
735 and 120.57. Cases filed under chapter 120 may combine all
736 disputes between parties.
737 (8) Notwithstanding any provision of chapter 381, a
738 hospital licensed under ss. 395.001-395.3025 that operates a
739 trauma center may not terminate or substantially reduce the
740 availability of trauma service without providing at least 180
741 days’ notice of its intent to terminate such service. Such
742 notice shall be given to the department, to all affected local
743 or regional trauma agencies, and to all trauma centers,
744 hospitals, and emergency medical service providers in the trauma
745 service area. The department shall adopt by rule the procedures
746 and process for notification, duration, and explanation of the
747 termination of trauma services.
748 (9) Except as otherwise provided in this subsection, the
749 department or its agent may collect trauma care and registry
750 data, as prescribed by rule of the department, from trauma
751 centers, hospitals, emergency medical service providers, local
752 or regional trauma agencies, or medical examiners for the
753 purposes of evaluating trauma system effectiveness, ensuring
754 compliance with the standards, and monitoring patient outcomes.
755 A trauma center, hospital, emergency medical service provider,
756 medical examiner, or local trauma agency or regional trauma
757 agency, or a panel or committee assembled by such an agency
758 under s. 395.50(1) may, but is not required to, disclose to the
759 department patient care quality assurance proceedings, records,
760 or reports. However, the department may require a local trauma
761 agency or a regional trauma agency, or a panel or committee
762 assembled by such an agency to disclose to the department
763 patient care quality assurance proceedings, records, or reports
764 that the department needs solely to conduct quality assurance
765 activities under s. 395.4015, or to ensure compliance with the
766 quality assurance component of the trauma agency’s plan approved
767 under s. 395.401. The patient care quality assurance
768 proceedings, records, or reports that the department may require
769 for these purposes include, but are not limited to, the
770 structure, processes, and procedures of the agency’s quality
771 assurance activities, and any recommendation for improving or
772 modifying the overall trauma system, if the identity of a trauma
773 center, hospital, emergency medical service provider, medical
774 examiner, or an individual who provides trauma services is not
775 disclosed.
776 (10) Out-of-state experts assembled by the department to
777 conduct onsite visits are agents of the department for the
778 purposes of s. 395.3025. An out-of-state expert who acts as an
779 agent of the department under this subsection is not liable for
780 any civil damages as a result of actions taken by him or her,
781 unless he or she is found to be operating outside the scope of
782 the authority and responsibility assigned by the department.
783 (11) Onsite visits by the department or its agent may be
784 conducted at any reasonable time and may include but not be
785 limited to a review of records in the possession of trauma
786 centers, hospitals, emergency medical service providers, local
787 or regional trauma agencies, or medical examiners regarding the
788 care, transport, treatment, or examination of trauma patients.
789 (12) Patient care, transport, or treatment records or
790 reports, or patient care quality assurance proceedings, records,
791 or reports obtained or made pursuant to this section, s.
792 395.3025(4)(f), s. 395.401, s. 395.4015, s. 395.402, s. 395.403,
793 s. 395.404, s. 395.4045, s. 395.405, s. 395.50, or s. 395.51
794 must be held confidential by the department or its agent and are
795 exempt from the provisions of s. 119.07(1). Patient care quality
796 assurance proceedings, records, or reports obtained or made
797 pursuant to these sections are not subject to discovery or
798 introduction into evidence in any civil or administrative
799 action.
800 (13) The department may adopt, by rule, the procedures and
801 process by which it will select trauma centers. Such procedures
802 and process must be used in annually selecting trauma centers
803 and must be consistent with subsections (1)-(8) except in those
804 situations in which it is in the best interest of, and mutually
805 agreed to by, all applicants within a service area and the
806 department to reduce the timeframes.
807 (14) Notwithstanding any other provisions of this section
808 and rules adopted pursuant to this section, until the department
809 has conducted the review provided under s. 395.402, only
810 hospitals located in trauma services areas where there is no
811 existing trauma center may apply.
812 Section 24. Subsections (1), (4), and (5) of section
813 395.3038, Florida Statutes, are amended to read:
814 395.3038 State-listed primary stroke centers and
815 comprehensive stroke centers; notification of hospitals.—
816 (1) The agency shall make available on its website and to
817 the department a list of the name and address of each hospital
818 that meets the criteria for a primary stroke center and the name
819 and address of each hospital that meets the criteria for a
820 comprehensive stroke center. The list of primary and
821 comprehensive stroke centers shall include only those hospitals
822 that attest in an affidavit submitted to the agency that the
823 hospital meets the named criteria, or those hospitals that
824 attest in an affidavit submitted to the agency that the hospital
825 is certified as a primary or a comprehensive stroke center by
826 the Joint Commission on Accreditation of Healthcare
827 Organizations.
828 (4) The agency shall adopt by rule criteria for a primary
829 stroke center which are substantially similar to the
830 certification standards for primary stroke centers of the Joint
831 Commission on Accreditation of Healthcare Organizations.
832 (5) The agency shall adopt by rule criteria for a
833 comprehensive stroke center. However, if the Joint Commission on
834 Accreditation of Healthcare Organizations establishes criteria
835 for a comprehensive stroke center, the agency shall establish
836 criteria for a comprehensive stroke center which are
837 substantially similar to those criteria established by the Joint
838 Commission on Accreditation of Healthcare Organizations.
839 Section 25. Paragraph (e) of subsection (2) of section
840 395.602, Florida Statutes, is amended to read:
841 395.602 Rural hospitals.—
842 (2) DEFINITIONS.—As used in this part:
843 (e) “Rural hospital” means an acute care hospital licensed
844 under this chapter, having 100 or fewer licensed beds and an
845 emergency room, which is:
846 1. The sole provider within a county with a population
847 density of no greater than 100 persons per square mile;
848 2. An acute care hospital, in a county with a population
849 density of no greater than 100 persons per square mile, which is
850 at least 30 minutes of travel time, on normally traveled roads
851 under normal traffic conditions, from any other acute care
852 hospital within the same county;
853 3. A hospital supported by a tax district or subdistrict
854 whose boundaries encompass a population of 100 persons or fewer
855 per square mile;
856 4. A hospital in a constitutional charter county with a
857 population of over 1 million persons that has imposed a local
858 option health service tax pursuant to law and in an area that
859 was directly impacted by a catastrophic event on August 24,
860 1992, for which the Governor of Florida declared a state of
861 emergency pursuant to chapter 125, and has 120 beds or less that
862 serves an agricultural community with an emergency room
863 utilization of no less than 20,000 visits and a Medicaid
864 inpatient utilization rate greater than 15 percent;
865 4.5. A hospital with a service area that has a population
866 of 100 persons or fewer per square mile. As used in this
867 subparagraph, the term “service area” means the fewest number of
868 zip codes that account for 75 percent of the hospital’s
869 discharges for the most recent 5-year period, based on
870 information available from the hospital inpatient discharge
871 database in the Florida Center for Health Information and Policy
872 Analysis at the Agency for Health Care Administration; or
873 5.6. A hospital designated as a critical access hospital,
874 as defined in s. 408.07(15).
875
876 Population densities used in this paragraph must be based upon
877 the most recently completed United States census. A hospital
878 that received funds under s. 409.9116 for a quarter beginning no
879 later than July 1, 2002, is deemed to have been and shall
880 continue to be a rural hospital from that date through June 30,
881 2015, if the hospital continues to have 100 or fewer licensed
882 beds and an emergency room, or meets the criteria of
883 subparagraph 4. An acute care hospital that has not previously
884 been designated as a rural hospital and that meets the criteria
885 of this paragraph shall be granted such designation upon
886 application, including supporting documentation to the Agency
887 for Health Care Administration.
888 Section 26. Subsections (8) and (16) of section 400.021,
889 Florida Statutes, are amended to read:
890 400.021 Definitions.—When used in this part, unless the
891 context otherwise requires, the term:
892 (8) “Geriatric outpatient clinic” means a site for
893 providing outpatient health care to persons 60 years of age or
894 older, which is staffed by a registered nurse or a physician
895 assistant, or by a licensed practical nurse who is under the
896 direct supervision of a registered nurse, an advanced registered
897 nurse practitioner, a physician assistant, or a physician.
898 (16) “Resident care plan” means a written plan developed,
899 maintained, and reviewed not less than quarterly by a registered
900 nurse, with participation from other facility staff and the
901 resident or his or her designee or legal representative, which
902 includes a comprehensive assessment of the needs of an
903 individual resident; the type and frequency of services required
904 to provide the necessary care for the resident to attain or
905 maintain the highest practicable physical, mental, and
906 psychosocial well-being; a listing of services provided within
907 or outside the facility to meet those needs; and an explanation
908 of service goals. The resident care plan must be signed by the
909 director of nursing or another registered nurse employed by the
910 facility to whom institutional responsibilities have been
911 delegated and by the resident, the resident’s designee, or the
912 resident’s legal representative. The facility may not use an
913 agency or temporary registered nurse to satisfy the foregoing
914 requirement and must document the institutional responsibilities
915 that have been delegated to the registered nurse.
916 Section 27. Paragraph (g) of subsection (2) of section
917 400.0239, Florida Statutes, is amended to read:
918 400.0239 Quality of Long-Term Care Facility Improvement
919 Trust Fund.—
920 (2) Expenditures from the trust fund shall be allowable for
921 direct support of the following:
922 (g) Other initiatives authorized by the Centers for
923 Medicare and Medicaid Services for the use of federal civil
924 monetary penalties, including projects recommended through the
925 Medicaid “Up-or-Out” Quality of Care Contract Management Program
926 pursuant to s. 400.148.
927 Section 28. Subsection (15) of section 400.0255, Florida
928 Statutes, is amended to read:
929 400.0255 Resident transfer or discharge; requirements and
930 procedures; hearings.—
931 (15)(a) The department’s Office of Appeals Hearings shall
932 conduct hearings requested under this section.
933 (a) The office shall notify the facility of a resident’s
934 request for a hearing.
935 (b) The department shall, by rule, establish procedures to
936 be used for fair hearings requested by residents. The These
937 procedures must shall be equivalent to the procedures used for
938 fair hearings for other Medicaid cases brought pursuant to s.
939 409.285 and applicable rules, chapter 10-2, part VI, Florida
940 Administrative Code. The burden of proof must be clear and
941 convincing evidence. A hearing decision must be rendered within
942 90 days after receipt of the request for hearing.
943 (c) If the hearing decision is favorable to the resident
944 who has been transferred or discharged, the resident must be
945 readmitted to the facility’s first available bed.
946 (d) The decision of the hearing officer is shall be final.
947 Any aggrieved party may appeal the decision to the district
948 court of appeal in the appellate district where the facility is
949 located. Review procedures shall be conducted in accordance with
950 the Florida Rules of Appellate Procedure.
951 Section 29. Subsection (2) of section 400.063, Florida
952 Statutes, is amended to read:
953 400.063 Resident protection.—
954 (2) The agency is authorized to establish for each
955 facility, subject to intervention by the agency, may establish a
956 separate bank account for the deposit to the credit of the
957 agency of any moneys received from the Health Care Trust Fund or
958 any other moneys received for the maintenance and care of
959 residents in the facility, and may the agency is authorized to
960 disburse moneys from such account to pay obligations incurred
961 for the purposes of this section. The agency may is authorized
962 to requisition moneys from the Health Care Trust Fund in advance
963 of an actual need for cash on the basis of an estimate by the
964 agency of moneys to be spent under the authority of this
965 section. A Any bank account established under this section need
966 not be approved in advance of its creation as required by s.
967 17.58, but must shall be secured by depository insurance equal
968 to or greater than the balance of such account or by the pledge
969 of collateral security in conformance with criteria established
970 in s. 18.11. The agency shall notify the Chief Financial Officer
971 of an any such account so established and shall make a quarterly
972 accounting to the Chief Financial Officer for all moneys
973 deposited in such account.
974 Section 30. Subsections (1) and (5) of section 400.071,
975 Florida Statutes, are amended to read:
976 400.071 Application for license.—
977 (1) In addition to the requirements of part II of chapter
978 408, the application for a license must shall be under oath and
979 must contain the following:
980 (a) The location of the facility for which a license is
981 sought and an indication, as in the original application, that
982 such location conforms to the local zoning ordinances.
983 (b) A signed affidavit disclosing any financial or
984 ownership interest that a controlling interest as defined in
985 part II of chapter 408 has held in the last 5 years in any
986 entity licensed by this state or any other state to provide
987 health or residential care which has closed voluntarily or
988 involuntarily; has filed for bankruptcy; has had a receiver
989 appointed; has had a license denied, suspended, or revoked; or
990 has had an injunction issued against it which was initiated by a
991 regulatory agency. The affidavit must disclose the reason any
992 such entity was closed, whether voluntarily or involuntarily.
993 (c) The total number of beds and the total number of
994 Medicare and Medicaid certified beds.
995 (b)(d) Information relating to the applicant and employees
996 which the agency requires by rule. The applicant must
997 demonstrate that sufficient numbers of qualified staff, by
998 training or experience, will be employed to properly care for
999 the type and number of residents who will reside in the
1000 facility.
1001 (e) Copies of any civil verdict or judgment involving the
1002 applicant rendered within the 10 years preceding the
1003 application, relating to medical negligence, violation of
1004 residents’ rights, or wrongful death. As a condition of
1005 licensure, the licensee agrees to provide to the agency copies
1006 of any new verdict or judgment involving the applicant, relating
1007 to such matters, within 30 days after filing with the clerk of
1008 the court. The information required in this paragraph shall be
1009 maintained in the facility’s licensure file and in an agency
1010 database which is available as a public record.
1011 (5) As a condition of licensure, each facility must
1012 establish and submit with its application a plan for quality
1013 assurance and for conducting risk management.
1014 Section 31. Section 400.0712, Florida Statutes, is amended
1015 to read:
1016 400.0712 Application for inactive license.—
1017 (1) As specified in this section, the agency may issue an
1018 inactive license to a nursing home facility for all or a portion
1019 of its beds. Any request by a licensee that a nursing home or
1020 portion of a nursing home become inactive must be submitted to
1021 the agency in the approved format. The facility may not initiate
1022 any suspension of services, notify residents, or initiate
1023 inactivity before receiving approval from the agency; and a
1024 licensee that violates this provision may not be issued an
1025 inactive license.
1026 (1)(2) In addition to the powers granted under part II of
1027 chapter 408, the agency may issue an inactive license for a
1028 portion of the total beds of to a nursing home facility that
1029 chooses to use an unoccupied contiguous portion of the facility
1030 for an alternative use to meet the needs of elderly persons
1031 through the use of less restrictive, less institutional
1032 services.
1033 (a) The An inactive license issued under this subsection
1034 may be granted for a period not to exceed the current licensure
1035 expiration date but may be renewed by the agency at the time of
1036 licensure renewal.
1037 (b) A request to extend the inactive license must be
1038 submitted to the agency in the approved format and approved by
1039 the agency in writing.
1040 (c) A facility Nursing homes that receives receive an
1041 inactive license to provide alternative services may shall not
1042 be given receive preference for participation in the Assisted
1043 Living for the Elderly Medicaid waiver.
1044 (2)(3) The agency shall adopt rules pursuant to ss.
1045 120.536(1) and 120.54 necessary to administer implement this
1046 section.
1047 Section 32. Section 400.111, Florida Statutes, is amended
1048 to read:
1049 400.111 Disclosure of controlling interest.—In addition to
1050 the requirements of part II of chapter 408, the nursing home
1051 facility, if requested by the agency, licensee shall submit a
1052 signed affidavit disclosing any financial or ownership interest
1053 that a controlling interest has held within the last 5 years in
1054 any entity licensed by the state or any other state to provide
1055 health or residential care which entity has closed voluntarily
1056 or involuntarily; has filed for bankruptcy; has had a receiver
1057 appointed; has had a license denied, suspended, or revoked; or
1058 has had an injunction issued against it which was initiated by a
1059 regulatory agency. The affidavit must disclose the reason such
1060 entity was closed, whether voluntarily or involuntarily.
1061 Section 33. Subsection (2) of section 400.1183, Florida
1062 Statutes, is amended to read:
1063 400.1183 Resident grievance procedures.—
1064 (2) Each nursing home facility shall maintain records of
1065 all grievances and a shall report, subject to agency inspection,
1066 of to the agency at the time of relicensure the total number of
1067 grievances handled during the prior licensure period, a
1068 categorization of the cases underlying the grievances, and the
1069 final disposition of the grievances.
1070 Section 34. Section 400.141, Florida Statutes, is amended
1071 to read:
1072 400.141 Administration and management of nursing home
1073 facilities.—
1074 (1) A nursing home facility must Every licensed facility
1075 shall comply with all applicable standards and rules of the
1076 agency and must shall:
1077 (a) Be under the administrative direction and charge of a
1078 licensed administrator.
1079 (b) Appoint a medical director licensed pursuant to chapter
1080 458 or chapter 459. The agency may establish by rule more
1081 specific criteria for the appointment of a medical director.
1082 (c) Have available the regular, consultative, and emergency
1083 services of state-licensed physicians licensed by the state.
1084 (d) Provide for resident use of a community pharmacy as
1085 specified in s. 400.022(1)(q). Notwithstanding any other law to
1086 the contrary notwithstanding, a registered pharmacist licensed
1087 in this state who in Florida, that is under contract with a
1088 facility licensed under this chapter or chapter 429 must, shall
1089 repackage a nursing facility resident’s bulk prescription
1090 medication, which was has been packaged by another pharmacist
1091 licensed in any state, in the United States into a unit dose
1092 system compatible with the system used by the nursing home
1093 facility, if the pharmacist is requested to offer such service.
1094 1. In order to be eligible for the repackaging, a resident
1095 or the resident’s spouse must receive prescription medication
1096 benefits provided through a former employer as part of his or
1097 her retirement benefits, a qualified pension plan as specified
1098 in s. 4972 of the Internal Revenue Code, a federal retirement
1099 program as specified under 5 C.F.R. s. 831, or a long-term care
1100 policy as defined in s. 627.9404(1).
1101 2. A pharmacist who correctly repackages and relabels the
1102 medication and the nursing facility that which correctly
1103 administers such repackaged medication under this paragraph may
1104 not be held liable in any civil or administrative action arising
1105 from the repackaging.
1106 3. In order to be eligible for the repackaging, a nursing
1107 facility resident for whom the medication is to be repackaged
1108 must shall sign an informed consent form provided by the
1109 facility which includes an explanation of the repackaging
1110 process and which notifies the resident of the immunities from
1111 liability provided under in this paragraph.
1112 4. A pharmacist who repackages and relabels prescription
1113 medications, as authorized under this paragraph, may charge a
1114 reasonable fee for costs resulting from the implementation of
1115 this provision.
1116 (e) Provide for the access of the facility residents with
1117 access to dental and other health-related services, recreational
1118 services, rehabilitative services, and social work services
1119 appropriate to their needs and conditions and not directly
1120 furnished by the licensee. If When a geriatric outpatient nurse
1121 clinic is conducted in accordance with rules adopted by the
1122 agency, outpatients attending such clinic may shall not be
1123 counted as part of the general resident population of the
1124 nursing home facility, nor may shall the nursing staff of the
1125 geriatric outpatient clinic be counted as part of the nursing
1126 staff of the facility, until the outpatient clinic load exceeds
1127 15 a day.
1128 (f) Be allowed and encouraged by the agency to provide
1129 other needed services under certain conditions. If the facility
1130 has a standard licensure status, and has had no class I or class
1131 II deficiencies during the past 2 years or has been awarded a
1132 Gold Seal under the program established in s. 400.235, it may be
1133 encouraged by the agency to provide services, including, but not
1134 limited to, respite and adult day services, which enable
1135 individuals to move in and out of the facility. A facility is
1136 not subject to any additional licensure requirements for
1137 providing these services, under the following conditions:.
1138 1. Respite care may be offered to persons in need of short
1139 term or temporary nursing home services, if for each person
1140 admitted under the respite care program, the licensee:.
1141 a. Has a contract that, at a minimum, specifies the
1142 services to be provided to the respite resident and includes the
1143 charges for services, activities, equipment, emergency medical
1144 services, and the administration of medications. If multiple
1145 respite admissions for a single individual are anticipated, the
1146 original contract is valid for 1 year after the date of
1147 execution;
1148 b. Has a written abbreviated plan of care that, at a
1149 minimum, includes nutritional requirements, medication orders,
1150 physician assessments and orders, nursing assessments, and
1151 dietary preferences. The physician or nursing assessments may
1152 take the place of all other assessments required for full-time
1153 residents; and
1154 c. Ensures that each respite resident is released to his or
1155 her caregiver or an individual designated in writing by the
1156 caregiver.
1157 2. A person admitted under a respite care program is:
1158 a. Covered by the residents’ rights set forth in s.
1159 400.022(1)(a)-(o) and (r)-(t). Funds or property of the respite
1160 resident are not considered trust funds subject to s.
1161 400.022(1)(h) until the resident has been in the facility for
1162 more than 14 consecutive days;
1163 b. Allowed to use his or her personal medications for the
1164 respite stay if permitted by facility policy. The facility must
1165 obtain a physician’s order for the medications. The caregiver
1166 may provide information regarding the medications as part of the
1167 nursing assessment which must agree with the physician’s order.
1168 Medications shall be released with the respite resident upon
1169 discharge in accordance with current physician’s orders; and
1170 c. Exempt from rule requirements related to discharge
1171 planning.
1172 3. A person receiving respite care is entitled to reside in
1173 the facility for a total of 60 days within a contract year or
1174 calendar year if the contract is for less than 12 months.
1175 However, each single stay may not exceed 14 days. If a stay
1176 exceeds 14 consecutive days, the facility must comply with all
1177 assessment and care planning requirements applicable to nursing
1178 home residents.
1179 4. The respite resident provided medical information from a
1180 physician, physician assistant, or nurse practitioner and other
1181 information from the primary caregiver as may be required by the
1182 facility before or at the time of admission. The medical
1183 information must include a physician’s order for respite care
1184 and proof of a physical examination by a licensed physician,
1185 physician assistant, or nurse practitioner. The physician’s
1186 order and physical examination may be used to provide
1187 intermittent respite care for up to 12 months after the date the
1188 order is written.
1189 5. A person receiving respite care resides in a licensed
1190 nursing home bed.
1191 6. The facility assumes the duties of the primary
1192 caregiver. To ensure continuity of care and services, the
1193 respite resident is entitled to retain his or her personal
1194 physician and must have access to medically necessary services
1195 such as physical therapy, occupational therapy, or speech
1196 therapy, as needed. The facility must arrange for transportation
1197 to these services if necessary. Respite care must be provided in
1198 accordance with this part and rules adopted by the agency.
1199 However, the agency shall, by rule, adopt modified requirements
1200 for resident assessment, resident care plans, resident
1201 contracts, physician orders, and other provisions, as
1202 appropriate, for short-term or temporary nursing home services.
1203 7. The agency allows shall allow for shared programming and
1204 staff in a facility that which meets minimum standards and
1205 offers services pursuant to this paragraph, but, if the facility
1206 is cited for deficiencies in patient care, the agency may
1207 require additional staff and programs appropriate to the needs
1208 of service recipients. A person who receives respite care may
1209 not be counted as a resident of the facility for purposes of the
1210 facility’s licensed capacity unless that person receives 24-hour
1211 respite care. A person receiving either respite care for 24
1212 hours or longer or adult day services must be included when
1213 calculating minimum staffing for the facility. Any costs and
1214 revenues generated by a nursing home facility from
1215 nonresidential programs or services must shall be excluded from
1216 the calculations of Medicaid per diems for nursing home
1217 institutional care reimbursement.
1218 (g) If the facility has a standard license or is a Gold
1219 Seal facility, exceeds the minimum required hours of licensed
1220 nursing and certified nursing assistant direct care per resident
1221 per day, and is part of a continuing care facility licensed
1222 under chapter 651 or a retirement community that offers other
1223 services pursuant to part III of this chapter or part I or part
1224 III of chapter 429 on a single campus, be allowed to share
1225 programming and staff. At the time of inspection and in the
1226 semiannual report required pursuant to paragraph (o), a
1227 continuing care facility or retirement community that uses this
1228 option must demonstrate through staffing records that minimum
1229 staffing requirements for the facility were met. Licensed nurses
1230 and certified nursing assistants who work in the nursing home
1231 facility may be used to provide services elsewhere on campus if
1232 the facility exceeds the minimum number of direct care hours
1233 required per resident per day and the total number of residents
1234 receiving direct care services from a licensed nurse or a
1235 certified nursing assistant does not cause the facility to
1236 violate the staffing ratios required under s. 400.23(3)(a).
1237 Compliance with the minimum staffing ratios must shall be based
1238 on the total number of residents receiving direct care services,
1239 regardless of where they reside on campus. If the facility
1240 receives a conditional license, it may not share staff until the
1241 conditional license status ends. This paragraph does not
1242 restrict the agency’s authority under federal or state law to
1243 require additional staff if a facility is cited for deficiencies
1244 in care which are caused by an insufficient number of certified
1245 nursing assistants or licensed nurses. The agency may adopt
1246 rules for the documentation necessary to determine compliance
1247 with this provision.
1248 (h) Maintain the facility premises and equipment and
1249 conduct its operations in a safe and sanitary manner.
1250 (i) If the licensee furnishes food service, provide a
1251 wholesome and nourishing diet sufficient to meet generally
1252 accepted standards of proper nutrition for its residents and
1253 provide such therapeutic diets as may be prescribed by attending
1254 physicians. In adopting making rules to implement this
1255 paragraph, the agency shall be guided by standards recommended
1256 by nationally recognized professional groups and associations
1257 with knowledge of dietetics.
1258 (j) Keep full records of resident admissions and
1259 discharges; medical and general health status, including medical
1260 records, personal and social history, and identity and address
1261 of next of kin or other persons who may have responsibility for
1262 the affairs of the resident residents; and individual resident
1263 care plans, including, but not limited to, prescribed services,
1264 service frequency and duration, and service goals. The records
1265 must shall be open to agency inspection by the agency. The
1266 licensee shall maintain clinical records on each resident in
1267 accordance with accepted professional standards and practices,
1268 which must be complete, accurately documented, readily
1269 accessible, and systematically organized.
1270 (k) Keep such fiscal records of its operations and
1271 conditions as may be necessary to provide information pursuant
1272 to this part.
1273 (l) Furnish copies of personnel records for employees
1274 affiliated with such facility, to any other facility licensed by
1275 this state requesting this information pursuant to this part.
1276 Such information contained in the records may include, but is
1277 not limited to, disciplinary matters and reasons any reason for
1278 termination. A Any facility releasing such records pursuant to
1279 this part is shall be considered to be acting in good faith and
1280 may not be held liable for information contained in such
1281 records, absent a showing that the facility maliciously
1282 falsified such records.
1283 (m) Publicly display a poster provided by the agency
1284 containing the names, addresses, and telephone numbers for the
1285 state’s abuse hotline, the State Long-Term Care Ombudsman, the
1286 Agency for Health Care Administration consumer hotline, the
1287 Advocacy Center for Persons with Disabilities, the Florida
1288 Statewide Advocacy Council, and the Medicaid Fraud Control Unit,
1289 with a clear description of the assistance to be expected from
1290 each.
1291 (n) Submit to the agency the information specified in s.
1292 400.071(1)(b) for a management company within 30 days after the
1293 effective date of the management agreement.
1294 (o)1. Submit semiannually to the agency, or more frequently
1295 if requested by the agency, information regarding facility
1296 staff-to-resident ratios, staff turnover, and staff stability,
1297 including information regarding certified nursing assistants,
1298 licensed nurses, the director of nursing, and the facility
1299 administrator. For purposes of this reporting:
1300 a. Staff-to-resident ratios must be reported in the
1301 categories specified in s. 400.23(3)(a) and applicable rules.
1302 The ratio must be reported as an average for the most recent
1303 calendar quarter.
1304 b. Staff turnover must be reported for the most recent 12
1305 month period ending on the last workday of the most recent
1306 calendar quarter prior to the date the information is submitted.
1307 The turnover rate must be computed quarterly, with the annual
1308 rate being the cumulative sum of the quarterly rates. The
1309 turnover rate is the total number of terminations or separations
1310 experienced during the quarter, excluding any employee
1311 terminated during a probationary period of 3 months or less,
1312 divided by the total number of staff employed at the end of the
1313 period for which the rate is computed, and expressed as a
1314 percentage.
1315 c. The formula for determining staff stability is the total
1316 number of employees that have been employed for more than 12
1317 months, divided by the total number of employees employed at the
1318 end of the most recent calendar quarter, and expressed as a
1319 percentage.
1320 (n) Comply with state minimum-staffing requirements:
1321 1.d. A nursing facility that has failed to comply with
1322 state minimum-staffing requirements for 2 consecutive days is
1323 prohibited from accepting new admissions until the facility has
1324 achieved the minimum-staffing requirements for a period of 6
1325 consecutive days. For the purposes of this subparagraph sub
1326 subparagraph, any person who was a resident of the facility and
1327 was absent from the facility for the purpose of receiving
1328 medical care at a separate location or was on a leave of absence
1329 is not considered a new admission. Failure by the facility to
1330 impose such an admissions moratorium is subject to a $1,000 fine
1331 constitutes a class II deficiency.
1332 2.e. A nursing facility that which does not have a
1333 conditional license may be cited for failure to comply with the
1334 standards in s. 400.23(3)(a)1.b. and c. only if it has failed to
1335 meet those standards on 2 consecutive days or if it has failed
1336 to meet at least 97 percent of those standards on any one day.
1337 3.f. A facility that which has a conditional license must
1338 be in compliance with the standards in s. 400.23(3)(a) at all
1339 times.
1340 2. This paragraph does not limit the agency’s ability to
1341 impose a deficiency or take other actions if a facility does not
1342 have enough staff to meet the residents’ needs.
1343 (o)(p) Notify a licensed physician when a resident exhibits
1344 signs of dementia or cognitive impairment or has a change of
1345 condition in order to rule out the presence of an underlying
1346 physiological condition that may be contributing to such
1347 dementia or impairment. The notification must occur within 30
1348 days after the acknowledgment of such signs by facility staff.
1349 If an underlying condition is determined to exist, the facility
1350 shall arrange, with the appropriate health care provider,
1351 arrange for the necessary care and services to treat the
1352 condition.
1353 (p)(q) If the facility implements a dining and hospitality
1354 attendant program, ensure that the program is developed and
1355 implemented under the supervision of the facility director of
1356 nursing. A licensed nurse, licensed speech or occupational
1357 therapist, or a registered dietitian must conduct training of
1358 dining and hospitality attendants. A person employed by a
1359 facility as a dining and hospitality attendant must perform
1360 tasks under the direct supervision of a licensed nurse.
1361 (r) Report to the agency any filing for bankruptcy
1362 protection by the facility or its parent corporation,
1363 divestiture or spin-off of its assets, or corporate
1364 reorganization within 30 days after the completion of such
1365 activity.
1366 (q)(s) Maintain general and professional liability
1367 insurance coverage that is in force at all times. In lieu of
1368 such general and professional liability insurance coverage, a
1369 state-designated teaching nursing home and its affiliated
1370 assisted living facilities created under s. 430.80 may
1371 demonstrate proof of financial responsibility as provided in s.
1372 430.80(3)(g).
1373 (r)(t) Maintain in the medical record for each resident a
1374 daily chart of certified nursing assistant services provided to
1375 the resident. The certified nursing assistant who is caring for
1376 the resident must complete this record by the end of his or her
1377 shift. The This record must indicate assistance with activities
1378 of daily living, assistance with eating, and assistance with
1379 drinking, and must record each offering of nutrition and
1380 hydration for those residents whose plan of care or assessment
1381 indicates a risk for malnutrition or dehydration.
1382 (s)(u) Before November 30 of each year, subject to the
1383 availability of an adequate supply of the necessary vaccine,
1384 provide for immunizations against influenza viruses to all its
1385 consenting residents in accordance with the recommendations of
1386 the United States Centers for Disease Control and Prevention,
1387 subject to exemptions for medical contraindications and
1388 religious or personal beliefs. Subject to these exemptions, any
1389 consenting person who becomes a resident of the facility after
1390 November 30 but before March 31 of the following year must be
1391 immunized within 5 working days after becoming a resident.
1392 Immunization may shall not be provided to any resident who
1393 provides documentation that he or she has been immunized as
1394 required by this paragraph. This paragraph does not prohibit a
1395 resident from receiving the immunization from his or her
1396 personal physician if he or she so chooses. A resident who
1397 chooses to receive the immunization from his or her personal
1398 physician shall provide proof of immunization to the facility.
1399 The agency may adopt and enforce any rules necessary to
1400 administer comply with or implement this paragraph.
1401 (t)(v) Assess all residents for eligibility for
1402 pneumococcal polysaccharide vaccination or revaccination (PPV)
1403 and vaccinate residents when indicated within 60 days after the
1404 effective date of this act in accordance with the
1405 recommendations of the United States Centers for Disease Control
1406 and Prevention, subject to exemptions for medical
1407 contraindications and religious or personal beliefs. Residents
1408 admitted after the effective date of this act shall be assessed
1409 within 5 working days after of admission and, if when indicated,
1410 vaccinate such residents vaccinated within 60 days in accordance
1411 with the recommendations of the United States Centers for
1412 Disease Control and Prevention, subject to exemptions for
1413 medical contraindications and religious or personal beliefs.
1414 Immunization may shall not be provided to any resident who
1415 provides documentation that he or she has been immunized as
1416 required by this paragraph. This paragraph does not prohibit a
1417 resident from receiving the immunization from his or her
1418 personal physician if he or she so chooses. A resident who
1419 chooses to receive the immunization from his or her personal
1420 physician shall provide proof of immunization to the facility.
1421 The agency may adopt and enforce any rules necessary to
1422 administer comply with or implement this paragraph.
1423 (u)(w) Annually encourage and promote to its employees the
1424 benefits associated with immunizations against influenza viruses
1425 in accordance with the recommendations of the United States
1426 Centers for Disease Control and Prevention. The agency may adopt
1427 and enforce any rules necessary to administer comply with or
1428 implement this paragraph.
1429
1430 This subsection does not limit the agency’s ability to impose a
1431 deficiency or take other actions if a facility does not have
1432 enough staff to meet residents’ needs.
1433 (2) Facilities that have been awarded a Gold Seal under the
1434 program established in s. 400.235 may develop a plan to provide
1435 certified nursing assistant training as prescribed by federal
1436 regulations and state rules and may apply to the agency for
1437 approval of their program.
1438 Section 35. Subsection (3) of section 400.142, Florida
1439 Statutes, is amended to read:
1440 400.142 Emergency medication kits; orders not to
1441 resuscitate.—
1442 (3) Facility staff may withhold or withdraw cardiopulmonary
1443 resuscitation if presented with an order not to resuscitate
1444 executed pursuant to s. 401.45. The agency shall adopt rules
1445 providing for the implementation of such orders. Facility staff
1446 and facilities are shall not be subject to criminal prosecution
1447 or civil liability, or nor be considered to have engaged in
1448 negligent or unprofessional conduct, for withholding or
1449 withdrawing cardiopulmonary resuscitation pursuant to such an
1450 order and rules adopted by the agency. The absence of an order
1451 not to resuscitate executed pursuant to s. 401.45 does not
1452 preclude a physician from withholding or withdrawing
1453 cardiopulmonary resuscitation as otherwise permitted by law.
1454 Section 36. Subsections (9) through (15) of section
1455 400.147, Florida Statutes, are renumbered as subsections (8)
1456 through (13), respectively, and present subsections (7), (8),
1457 and (10) of that section are amended to read:
1458 400.147 Internal risk management and quality assurance
1459 program.—
1460 (7) The nursing home facility shall initiate an
1461 investigation and shall notify the agency within 1 business day
1462 after the risk manager or his or her designee has received a
1463 report pursuant to paragraph (1)(d). The facility must complete
1464 the investigation and submit a report to the agency within 15
1465 calendar days after the adverse incident occurred. The
1466 notification must be made in writing and be provided
1467 electronically, by facsimile device or overnight mail delivery.
1468 The agency shall develop a form for the report which
1469 notification must include the name of the risk manager,
1470 information regarding the identity of the affected resident, the
1471 type of adverse incident, the initiation of an investigation by
1472 the facility, and whether the events causing or resulting in the
1473 adverse incident represent a potential risk to any other
1474 resident. The report notification is confidential as provided by
1475 law and is not discoverable or admissible in any civil or
1476 administrative action, except in disciplinary proceedings by the
1477 agency or the appropriate regulatory board. The agency may
1478 investigate, as it deems appropriate, any such incident and
1479 prescribe measures that must or may be taken in response to the
1480 incident. The agency shall review each report incident and
1481 determine whether it potentially involved conduct by the health
1482 care professional who is subject to disciplinary action, in
1483 which case the provisions of s. 456.073 shall apply.
1484 (8)(a) Each facility shall complete the investigation and
1485 submit an adverse incident report to the agency for each adverse
1486 incident within 15 calendar days after its occurrence. If, after
1487 a complete investigation, the risk manager determines that the
1488 incident was not an adverse incident as defined in subsection
1489 (5), the facility shall include this information in the report.
1490 The agency shall develop a form for reporting this information.
1491 (b) The information reported to the agency pursuant to
1492 paragraph (a) which relates to persons licensed under chapter
1493 458, chapter 459, chapter 461, or chapter 466 shall be reviewed
1494 by the agency. The agency shall determine whether any of the
1495 incidents potentially involved conduct by a health care
1496 professional who is subject to disciplinary action, in which
1497 case the provisions of s. 456.073 shall apply.
1498 (c) The report submitted to the agency must also contain
1499 the name of the risk manager of the facility.
1500 (d) The adverse incident report is confidential as provided
1501 by law and is not discoverable or admissible in any civil or
1502 administrative action, except in disciplinary proceedings by the
1503 agency or the appropriate regulatory board.
1504 (10) By the 10th of each month, each facility subject to
1505 this section shall report any notice received pursuant to s.
1506 400.0233(2) and each initial complaint that was filed with the
1507 clerk of the court and served on the facility during the
1508 previous month by a resident or a resident’s family member,
1509 guardian, conservator, or personal legal representative. The
1510 report must include the name of the resident, the resident’s
1511 date of birth and social security number, the Medicaid
1512 identification number for Medicaid-eligible persons, the date or
1513 dates of the incident leading to the claim or dates of
1514 residency, if applicable, and the type of injury or violation of
1515 rights alleged to have occurred. Each facility shall also submit
1516 a copy of the notices received pursuant to s. 400.0233(2) and
1517 complaints filed with the clerk of the court. This report is
1518 confidential as provided by law and is not discoverable or
1519 admissible in any civil or administrative action, except in such
1520 actions brought by the agency to enforce the provisions of this
1521 part.
1522 Section 37. Section 400.148, Florida Statutes, is repealed.
1523 Section 38. Subsection (3) of section 400.19, Florida
1524 Statutes, is amended to read:
1525 400.19 Right of entry and inspection.—
1526 (3) The agency shall every 15 months conduct at least one
1527 unannounced inspection every 15 months to determine the
1528 licensee’s compliance by the licensee with statutes, and related
1529 with rules promulgated under the provisions of those statutes,
1530 governing minimum standards of construction, quality and
1531 adequacy of care, and rights of residents. The survey must shall
1532 be conducted every 6 months for the next 2-year period if the
1533 nursing home facility has been cited for a class I deficiency,
1534 has been cited for two or more class II deficiencies arising
1535 from separate surveys or investigations within a 60-day period,
1536 or has had three or more substantiated complaints within a 6
1537 month period, each resulting in at least one class I or class II
1538 deficiency. In addition to any other fees or fines under in this
1539 part, the agency shall assess a fine for each facility that is
1540 subject to the 6-month survey cycle. The fine for the 2-year
1541 period is shall be $6,000, one-half to be paid at the completion
1542 of each survey. The agency may adjust this fine by the change in
1543 the Consumer Price Index, based on the 12 months immediately
1544 preceding the increase, to cover the cost of the additional
1545 surveys. The agency shall verify through subsequent inspection
1546 that any deficiency identified during inspection is corrected.
1547 However, the agency may verify the correction of a class III or
1548 class IV deficiency unrelated to resident rights or resident
1549 care without reinspecting the facility if adequate written
1550 documentation has been received from the facility, which
1551 provides assurance that the deficiency has been corrected. The
1552 giving or causing to be given of advance notice of such
1553 unannounced inspections by an employee of the agency to any
1554 unauthorized person shall constitute cause for suspension of at
1555 least not fewer than 5 working days according to the provisions
1556 of chapter 110.
1557 Section 39. Present subsection (6) of section 400.191,
1558 Florida Statutes, is renumbered as subsection (7), and a new
1559 subsection (6) is added to that section, to read:
1560 400.191 Availability, distribution, and posting of reports
1561 and records.—
1562 (6) A nursing home facility may charge a reasonable fee for
1563 copying resident records. The fee may not exceed $1 per page for
1564 the first 25 pages and 25 cents per page for each page in excess
1565 of 25 pages.
1566 Section 40. Subsection (5) of section 400.23, Florida
1567 Statutes, is amended to read:
1568 400.23 Rules; evaluation and deficiencies; licensure
1569 status.—
1570 (5) The agency, in collaboration with the Division of
1571 Children’s Medical Services of the Department of Health, must,
1572 no later than December 31, 1993, adopt rules for:
1573 (a) Minimum standards of care for persons under 21 years of
1574 age who reside in nursing home facilities. The rules must
1575 include a methodology for reviewing a nursing home facility
1576 under ss. 408.031-408.045 which serves only persons under 21
1577 years of age. A facility may be exempted exempt from these
1578 standards for specific persons between 18 and 21 years of age,
1579 if the person’s physician agrees that minimum standards of care
1580 based on age are not necessary.
1581 (b) Minimum staffing requirements for persons under 21
1582 years of age who reside in nursing home facilities, which apply
1583 in lieu of the requirements contained in subsection (3).
1584 1. For persons under 21 years of age who require skilled
1585 care:
1586 a. A minimum combined average of 3.9 hours of direct care
1587 per resident per day must be provided by licensed nurses,
1588 respiratory therapists, respiratory care practitioners, and
1589 certified nursing assistants.
1590 b. A minimum licensed nursing staffing of 1.0 hour of
1591 direct care per resident per day must be provided.
1592 c. No more than 1.5 hours of certified nursing assistant
1593 care per resident per day may be counted in determining the
1594 minimum direct care hours required.
1595 d. One registered nurse must be on duty on the site 24
1596 hours per day on the unit where children reside.
1597 2. For persons under 21 years of age who are medically
1598 fragile:
1599 a. A minimum combined average of 5.0 hours of direct care
1600 per resident per day must be provided by licensed nurses,
1601 respiratory therapists, respiratory care practitioners, and
1602 certified nursing assistants.
1603 b. A minimum licensed nursing staffing of 1.7 hours of
1604 direct care per resident per day must be provided.
1605 c. No more than 1.5 hours of certified nursing assistant
1606 care per resident per day may be counted in determining the
1607 minimum direct care hours required.
1608 d. One registered nurse must be on duty on the site 24
1609 hours per day on the unit where children reside.
1610 Section 41. Subsection (1) of section 400.275, Florida
1611 Statutes, is amended to read:
1612 400.275 Agency duties.—
1613 (1) The agency shall ensure that each newly hired nursing
1614 home surveyor, as a part of basic training, is assigned full
1615 time to a licensed nursing home for at least 2 days within a 7
1616 day period to observe facility operations outside of the survey
1617 process before the surveyor begins survey responsibilities. Such
1618 observations may not be the sole basis of a deficiency citation
1619 against the facility. The agency may not assign an individual to
1620 be a member of a survey team for purposes of a survey,
1621 evaluation, or consultation visit at a nursing home facility in
1622 which the surveyor was an employee within the preceding 2 5
1623 years.
1624 Section 42. Subsection (27) of section 400.462, Florida
1625 Statutes, is amended to read:
1626 400.462 Definitions.—As used in this part, the term:
1627 (27) “Remuneration” means any payment or other benefit made
1628 directly or indirectly, overtly or covertly, in cash or in kind.
1629 However, if the term is used in any provision of law relating to
1630 health care providers, the term does not apply to an item that
1631 has an individual value of up to $15, including, but not limited
1632 to, a plaque, a certificate, a trophy, or a novelty item that is
1633 intended solely for presentation or is customarily given away
1634 solely for promotional, recognition, or advertising purposes.
1635 Section 43. For the purpose of incorporating the amendment
1636 made by this act to section 400.509, Florida Statutes, in a
1637 reference thereto, paragraph (b) of subsection (5) of section
1638 400.464, Florida Statutes, is reenacted to read:
1639 400.464 Home health agencies to be licensed; expiration of
1640 license; exemptions; unlawful acts; penalties.—
1641 (5) The following are exempt from the licensure
1642 requirements of this part:
1643 (b) Home health services provided by a state agency, either
1644 directly or through a contractor with:
1645 1. The Department of Elderly Affairs.
1646 2. The Department of Health, a community health center, or
1647 a rural health network that furnishes home visits for the
1648 purpose of providing environmental assessments, case management,
1649 health education, personal care services, family planning, or
1650 followup treatment, or for the purpose of monitoring and
1651 tracking disease.
1652 3. Services provided to persons with developmental
1653 disabilities, as defined in s. 393.063.
1654 4. Companion and sitter organizations that were registered
1655 under s. 400.509(1) on January 1, 1999, and were authorized to
1656 provide personal services under a developmental services
1657 provider certificate on January 1, 1999, may continue to provide
1658 such services to past, present, and future clients of the
1659 organization who need such services, notwithstanding the
1660 provisions of this act.
1661 5. The Department of Children and Family Services.
1662 Section 44. Section 400.484, Florida Statutes, is amended
1663 to read:
1664 400.484 Right of inspection; violations deficiencies;
1665 fines.—
1666 (1) In addition to the requirements of s. 408.811, the
1667 agency may make such inspections and investigations as are
1668 necessary in order to determine the state of compliance with
1669 this part, part II of chapter 408, and applicable rules.
1670 (2) The agency shall impose fines for various classes of
1671 violations deficiencies in accordance with the following
1672 schedule:
1673 (a) A class I violation is defined in s. 408.813 deficiency
1674 is any act, omission, or practice that results in a patient’s
1675 death, disablement, or permanent injury, or places a patient at
1676 imminent risk of death, disablement, or permanent injury. Upon
1677 finding a class I violation deficiency, the agency shall impose
1678 an administrative fine in the amount of $15,000 for each
1679 occurrence and each day that the violation deficiency exists.
1680 (b) A class II violation is defined in s. 408.813
1681 deficiency is any act, omission, or practice that has a direct
1682 adverse effect on the health, safety, or security of a patient.
1683 Upon finding a class II violation deficiency, the agency shall
1684 impose an administrative fine in the amount of $5,000 for each
1685 occurrence and each day that the violation deficiency exists.
1686 (c) A class III violation is defined in s. 408.813
1687 deficiency is any act, omission, or practice that has an
1688 indirect, adverse effect on the health, safety, or security of a
1689 patient. Upon finding an uncorrected or repeated class III
1690 violation deficiency, the agency shall impose an administrative
1691 fine not to exceed $1,000 for each occurrence and each day that
1692 the uncorrected or repeated violation deficiency exists.
1693 (d) A class IV violation is defined in s. 408.813
1694 deficiency is any act, omission, or practice related to required
1695 reports, forms, or documents which does not have the potential
1696 of negatively affecting patients. These violations are of a type
1697 that the agency determines do not threaten the health, safety,
1698 or security of patients. Upon finding an uncorrected or repeated
1699 class IV violation deficiency, the agency shall impose an
1700 administrative fine not to exceed $500 for each occurrence and
1701 each day that the uncorrected or repeated violation deficiency
1702 exists.
1703 (3) In addition to any other penalties imposed pursuant to
1704 this section or part, the agency may assess costs related to an
1705 investigation that results in a successful prosecution,
1706 excluding costs associated with an attorney’s time.
1707 Section 45. Paragraph (a) of subsection (15) and subsection
1708 (16) of section 400.506, Florida Statutes, are amended, and
1709 paragraph (a) of subsection (6) of that section is reenacted for
1710 the purpose of incorporating the amendment made by this act to
1711 section 400.509, Florida Statutes, in a reference thereto, to
1712 read:
1713 400.506 Licensure of nurse registries; requirements;
1714 penalties.—
1715 (6)(a) A nurse registry may refer for contract in private
1716 residences registered nurses and licensed practical nurses
1717 registered and licensed under part I of chapter 464, certified
1718 nursing assistants certified under part II of chapter 464, home
1719 health aides who present documented proof of successful
1720 completion of the training required by rule of the agency, and
1721 companions or homemakers for the purposes of providing those
1722 services authorized under s. 400.509(1). A licensed nurse
1723 registry shall ensure that each certified nursing assistant
1724 referred for contract by the nurse registry and each home health
1725 aide referred for contract by the nurse registry is adequately
1726 trained to perform the tasks of a home health aide in the home
1727 setting. Each person referred by a nurse registry must provide
1728 current documentation that he or she is free from communicable
1729 diseases.
1730 (15)(a) The agency may deny, suspend, or revoke the license
1731 of a nurse registry and shall impose a fine of $5,000 against a
1732 nurse registry that:
1733 1. Provides services to residents in an assisted living
1734 facility for which the nurse registry does not receive fair
1735 market value remuneration.
1736 2. Provides staffing to an assisted living facility for
1737 which the nurse registry does not receive fair market value
1738 remuneration.
1739 3. Fails to provide the agency, upon request, with copies
1740 of all contracts with assisted living facilities which were
1741 executed within the last 5 years.
1742 4. Gives remuneration to a case manager, discharge planner,
1743 facility-based staff member, or third-party vendor who is
1744 involved in the discharge planning process of a facility
1745 licensed under chapter 395 or this chapter and from whom the
1746 nurse registry receives referrals. A nurse registry is exempt
1747 from this subparagraph if it does not bill the Florida Medicaid
1748 program or the Medicare program or share a controlling interest
1749 with any entity licensed, registered, or certified under part II
1750 of chapter 408 that bills the Florida Medicaid program or the
1751 Medicare program.
1752 5. Gives remuneration to a physician, a member of the
1753 physician’s office staff, or an immediate family member of the
1754 physician, and the nurse registry received a patient referral in
1755 the last 12 months from that physician or the physician’s office
1756 staff. A nurse registry is exempt from this subparagraph if it
1757 does not bill the Florida Medicaid program or the Medicare
1758 program or share a controlling interest with any entity
1759 licensed, registered, or certified under part II of chapter 408
1760 that bills the Florida Medicaid program or the Medicare program.
1761 (16) An administrator may manage only one nurse registry,
1762 except that an administrator may manage up to five registries if
1763 all five registries have identical controlling interests as
1764 defined in s. 408.803 and are located within one agency
1765 geographic service area or within an immediately contiguous
1766 county. An administrator shall designate, in writing, for each
1767 licensed entity, a qualified alternate administrator to serve
1768 during the administrator’s absence. In addition to any other
1769 penalties imposed pursuant to this section or part, the agency
1770 may assess costs related to an investigation that results in a
1771 successful prosecution, excluding costs associated with an
1772 attorney’s time.
1773 Section 46. Subsection (1) of section 400.509, Florida
1774 Statutes, is amended to read:
1775 400.509 Registration of particular service providers exempt
1776 from licensure; certificate of registration; regulation of
1777 registrants.—
1778 (1) Any organization that provides companion services or
1779 homemaker services and does not provide a home health service to
1780 a person is exempt from licensure under this part. However, any
1781 organization that provides companion services or homemaker
1782 services must register with the agency. An organization under
1783 contract with the Agency for Persons with Disabilities which
1784 provides companion services only for persons with a
1785 developmental disability, as defined in s. 393.063, is exempt
1786 from registration.
1787 Section 47. Subsection (3) of section 400.601, Florida
1788 Statutes, is amended to read:
1789 400.601 Definitions.—As used in this part, the term:
1790 (3) “Hospice” means a centrally administered corporation or
1791 a limited liability company that provides providing a continuum
1792 of palliative and supportive care for the terminally ill patient
1793 and his or her family.
1794 Section 48. Paragraph (i) of subsection (1) and subsection
1795 (4) of section 400.606, Florida Statutes, are amended to read:
1796 400.606 License; application; renewal; conditional license
1797 or permit; certificate of need.—
1798 (1) In addition to the requirements of part II of chapter
1799 408, the initial application and change of ownership application
1800 must be accompanied by a plan for the delivery of home,
1801 residential, and homelike inpatient hospice services to
1802 terminally ill persons and their families. Such plan must
1803 contain, but need not be limited to:
1804 (i) The projected annual operating cost of the hospice.
1805
1806 If the applicant is an existing licensed health care provider,
1807 the application must be accompanied by a copy of the most recent
1808 profit-loss statement and, if applicable, the most recent
1809 licensure inspection report.
1810 (4) A freestanding hospice facility that is primarily
1811 engaged in providing inpatient and related services and that is
1812 not otherwise licensed as a health care facility shall be
1813 required to obtain a certificate of need. However, a
1814 freestanding hospice facility that has with six or fewer beds is
1815 shall not be required to comply with institutional standards
1816 such as, but not limited to, standards requiring sprinkler
1817 systems, emergency electrical systems, or special lavatory
1818 devices.
1819 Section 49. Section 400.915, Florida Statutes, is amended
1820 to read:
1821 400.915 Construction and renovation; requirements.—The
1822 requirements for the construction or renovation of a PPEC center
1823 shall comply with:
1824 (1) The provisions of chapter 553, which pertain to
1825 building construction standards, including plumbing, electrical
1826 code, glass, manufactured buildings, accessibility for the
1827 physically disabled;
1828 (2) The provisions of s. 633.022 and applicable rules
1829 pertaining to physical minimum standards for nonresidential
1830 child care physical facilities in rule 10M-12.003, Florida
1831 Administrative Code, Child Care Standards; and
1832 (3) The standards or rules adopted pursuant to this part
1833 and part II of chapter 408.
1834 Section 50. Subsection (1) of section 400.925, Florida
1835 Statutes, is amended to read:
1836 400.925 Definitions.—As used in this part, the term:
1837 (1) “Accrediting organizations” means the Joint Commission
1838 on Accreditation of Healthcare Organizations or other national
1839 accreditation agencies whose standards for accreditation are
1840 comparable to those required by this part for licensure.
1841 Section 51. Section 400.931, Florida Statutes, is amended
1842 to read:
1843 400.931 Application for license; fee; provisional license;
1844 temporary permit.—
1845 (1) In addition to the requirements of part II of chapter
1846 408, the applicant must file with the application satisfactory
1847 proof that the home medical equipment provider is in compliance
1848 with this part and applicable rules, including:
1849 (a) A report, by category, of the equipment to be provided,
1850 indicating those offered either directly by the applicant or
1851 through contractual arrangements with existing providers.
1852 Categories of equipment include:
1853 1. Respiratory modalities.
1854 2. Ambulation aids.
1855 3. Mobility aids.
1856 4. Sickroom setup.
1857 5. Disposables.
1858 (b) A report, by category, of the services to be provided,
1859 indicating those offered either directly by the applicant or
1860 through contractual arrangements with existing providers.
1861 Categories of services include:
1862 1. Intake.
1863 2. Equipment selection.
1864 3. Delivery.
1865 4. Setup and installation.
1866 5. Patient training.
1867 6. Ongoing service and maintenance.
1868 7. Retrieval.
1869 (c) A listing of those with whom the applicant contracts,
1870 both the providers the applicant uses to provide equipment or
1871 services to its consumers and the providers for whom the
1872 applicant provides services or equipment.
1873 (2) An applicant for initial licensure, change of
1874 ownership, or license renewal to operate a licensed home medical
1875 equipment provider at a location outside the state must submit
1876 documentation of accreditation or an application for
1877 accreditation from an accrediting organization that is
1878 recognized by the agency. An applicant that has applied for
1879 accreditation must provide proof of accreditation that is not
1880 conditional or provisional within 120 days after the date the
1881 agency receives the application for licensure or the application
1882 shall be withdrawn from further consideration. Such
1883 accreditation must be maintained by the home medical equipment
1884 provider in order to maintain licensure. As an alternative to
1885 submitting proof of financial ability to operate as required in
1886 s. 408.810(8), the applicant may submit a $50,000 surety bond to
1887 the agency.
1888 (3) As specified in part II of chapter 408, the home
1889 medical equipment provider must also obtain and maintain
1890 professional and commercial liability insurance. Proof of
1891 liability insurance, as defined in s. 624.605, must be submitted
1892 with the application. The agency shall set the required amounts
1893 of liability insurance by rule, but the required amount must not
1894 be less than $250,000 per claim. In the case of contracted
1895 services, it is required that the contractor have liability
1896 insurance not less than $250,000 per claim.
1897 (4) When a change of the general manager of a home medical
1898 equipment provider occurs, the licensee must notify the agency
1899 of the change within 45 days.
1900 (5) In accordance with s. 408.805, an applicant or a
1901 licensee shall pay a fee for each license application submitted
1902 under this part, part II of chapter 408, and applicable rules.
1903 The amount of the fee shall be established by rule and may not
1904 exceed $300 per biennium. The agency shall set the fees in an
1905 amount that is sufficient to cover its costs in carrying out its
1906 responsibilities under this part. However, state, county, or
1907 municipal governments applying for licenses under this part are
1908 exempt from the payment of license fees.
1909 (6) An applicant for initial licensure, renewal, or change
1910 of ownership shall also pay an inspection fee not to exceed
1911 $400, which shall be paid by all applicants except those not
1912 subject to licensure inspection by the agency as described in s.
1913 400.933.
1914 Section 52. Section 400.967, Florida Statutes, is amended
1915 to read:
1916 400.967 Rules and classification of violations
1917 deficiencies.—
1918 (1) It is the intent of the Legislature that rules adopted
1919 and enforced under this part and part II of chapter 408 include
1920 criteria by which a reasonable and consistent quality of
1921 resident care may be ensured, the results of such resident care
1922 can be demonstrated, and safe and sanitary facilities can be
1923 provided.
1924 (2) Pursuant to the intention of the Legislature, the
1925 agency, in consultation with the Agency for Persons with
1926 Disabilities and the Department of Elderly Affairs, shall adopt
1927 and enforce rules to administer this part and part II of chapter
1928 408, which shall include reasonable and fair criteria governing:
1929 (a) The location and construction of the facility;
1930 including fire and life safety, plumbing, heating, cooling,
1931 lighting, ventilation, and other housing conditions that ensure
1932 the health, safety, and comfort of residents. The agency shall
1933 establish standards for facilities and equipment to increase the
1934 extent to which new facilities and a new wing or floor added to
1935 an existing facility after July 1, 2000, are structurally
1936 capable of serving as shelters only for residents, staff, and
1937 families of residents and staff, and equipped to be self
1938 supporting during and immediately following disasters. The
1939 agency shall update or revise the criteria as the need arises.
1940 All facilities must comply with those lifesafety code
1941 requirements and building code standards applicable at the time
1942 of approval of their construction plans. The agency may require
1943 alterations to a building if it determines that an existing
1944 condition constitutes a distinct hazard to life, health, or
1945 safety. The agency shall adopt fair and reasonable rules setting
1946 forth conditions under which existing facilities undergoing
1947 additions, alterations, conversions, renovations, or repairs are
1948 required to comply with the most recent updated or revised
1949 standards.
1950 (b) The number and qualifications of all personnel,
1951 including management, medical nursing, and other personnel,
1952 having responsibility for any part of the care given to
1953 residents.
1954 (c) All sanitary conditions within the facility and its
1955 surroundings, including water supply, sewage disposal, food
1956 handling, and general hygiene, which will ensure the health and
1957 comfort of residents.
1958 (d) The equipment essential to the health and welfare of
1959 the residents.
1960 (e) A uniform accounting system.
1961 (f) The care, treatment, and maintenance of residents and
1962 measurement of the quality and adequacy thereof.
1963 (g) The preparation and annual update of a comprehensive
1964 emergency management plan. The agency shall adopt rules
1965 establishing minimum criteria for the plan after consultation
1966 with the Division of Emergency Management. At a minimum, the
1967 rules must provide for plan components that address emergency
1968 evacuation transportation; adequate sheltering arrangements;
1969 postdisaster activities, including emergency power, food, and
1970 water; postdisaster transportation; supplies; staffing;
1971 emergency equipment; individual identification of residents and
1972 transfer of records; and responding to family inquiries. The
1973 comprehensive emergency management plan is subject to review and
1974 approval by the local emergency management agency. During its
1975 review, the local emergency management agency shall ensure that
1976 the following agencies, at a minimum, are given the opportunity
1977 to review the plan: the Department of Elderly Affairs, the
1978 Agency for Persons with Disabilities, the Agency for Health Care
1979 Administration, and the Division of Emergency Management. Also,
1980 appropriate volunteer organizations must be given the
1981 opportunity to review the plan. The local emergency management
1982 agency shall complete its review within 60 days and either
1983 approve the plan or advise the facility of necessary revisions.
1984 (h) The use of restraint and seclusion. Such rules must be
1985 consistent with recognized best practices; prohibit inherently
1986 dangerous restraint or seclusion procedures; establish
1987 limitations on the use and duration of restraint and seclusion;
1988 establish measures to ensure the safety of clients and staff
1989 during an incident of restraint or seclusion; establish
1990 procedures for staff to follow before, during, and after
1991 incidents of restraint or seclusion, including individualized
1992 plans for the use of restraints or seclusion in emergency
1993 situations; establish professional qualifications of and
1994 training for staff who may order or be engaged in the use of
1995 restraint or seclusion; establish requirements for facility data
1996 collection and reporting relating to the use of restraint and
1997 seclusion; and establish procedures relating to the
1998 documentation of the use of restraint or seclusion in the
1999 client’s facility or program record.
2000 (3) The agency shall adopt rules to provide that, when the
2001 criteria established under this part and part II of chapter 408
2002 are not met, such violations deficiencies shall be classified
2003 according to the nature of the violation deficiency. The agency
2004 shall indicate the classification on the face of the notice of
2005 violation deficiencies as follows:
2006 (a) A class I violation is defined in s. 408.813
2007 deficiencies are those which the agency determines present an
2008 imminent danger to the residents or guests of the facility or a
2009 substantial probability that death or serious physical harm
2010 would result therefrom. The condition or practice constituting a
2011 class I violation must be abated or eliminated immediately,
2012 unless a fixed period of time, as determined by the agency, is
2013 required for correction. A class I violation deficiency is
2014 subject to a civil penalty in an amount not less than $5,000 and
2015 not exceeding $10,000 for each violation deficiency. A fine may
2016 be levied notwithstanding the correction of the violation
2017 deficiency.
2018 (b) A class II violation is defined in s. 408.813
2019 deficiencies are those which the agency determines have a direct
2020 or immediate relationship to the health, safety, or security of
2021 the facility residents, other than class I deficiencies. A class
2022 II violation deficiency is subject to a civil penalty in an
2023 amount not less than $1,000 and not exceeding $5,000 for each
2024 violation deficiency. A citation for a class II violation
2025 deficiency shall specify the time within which the violation
2026 deficiency must be corrected. If a class II violation deficiency
2027 is corrected within the time specified, no civil penalty shall
2028 be imposed, unless it is a repeated offense.
2029 (c) A class III violation is defined in s. 408.813
2030 deficiencies are those which the agency determines to have an
2031 indirect or potential relationship to the health, safety, or
2032 security of the facility residents, other than class I or class
2033 II deficiencies. A class III violation deficiency is subject to
2034 a civil penalty of not less than $500 and not exceeding $1,000
2035 for each violation deficiency. A citation for a class III
2036 violation deficiency shall specify the time within which the
2037 violation deficiency must be corrected. If a class III violation
2038 deficiency is corrected within the time specified, no civil
2039 penalty shall be imposed, unless it is a repeated offense.
2040 (d) A class IV violation is defined in s. 408.813. Upon
2041 finding an uncorrected or repeated class IV violation, the
2042 agency shall impose an administrative fine not to exceed $500
2043 for each occurrence and each day that the uncorrected or
2044 repeated violation exists.
2045 (4) The agency shall approve or disapprove the plans and
2046 specifications within 60 days after receipt of the final plans
2047 and specifications. The agency may be granted one 15-day
2048 extension for the review period, if the secretary of the agency
2049 so approves. If the agency fails to act within the specified
2050 time, it is deemed to have approved the plans and
2051 specifications. When the agency disapproves plans and
2052 specifications, it must set forth in writing the reasons for
2053 disapproval. Conferences and consultations may be provided as
2054 necessary.
2055 (5) The agency may charge an initial fee of $2,000 for
2056 review of plans and construction on all projects, no part of
2057 which is refundable. The agency may also collect a fee, not to
2058 exceed 1 percent of the estimated construction cost or the
2059 actual cost of review, whichever is less, for the portion of the
2060 review which encompasses initial review through the initial
2061 revised construction document review. The agency may collect its
2062 actual costs on all subsequent portions of the review and
2063 construction inspections. Initial fee payment must accompany the
2064 initial submission of plans and specifications. Any subsequent
2065 payment that is due is payable upon receipt of the invoice from
2066 the agency. Notwithstanding any other provision of law, all
2067 money received by the agency under this section shall be deemed
2068 to be trust funds, to be held and applied solely for the
2069 operations required under this section.
2070 Section 53. Subsections (4) and (7) of section 400.9905,
2071 Florida Statutes, are amended to read:
2072 400.9905 Definitions.—
2073 (4) “Clinic” means an entity at which health care services
2074 are provided to individuals and which tenders charges for
2075 reimbursement for such services, including a mobile clinic and a
2076 portable health service or equipment provider. For purposes of
2077 this part, the term does not include and the licensure
2078 requirements of this part do not apply to:
2079 (a) Entities licensed or registered by the state under
2080 chapter 395; or entities licensed or registered by the state and
2081 providing only health care services within the scope of services
2082 authorized under their respective licenses granted under ss.
2083 383.30-383.335, chapter 390, chapter 394, chapter 397, this
2084 chapter except part X, chapter 429, chapter 463, chapter 465,
2085 chapter 466, chapter 478, part I of chapter 483, chapter 484, or
2086 chapter 651; end-stage renal disease providers authorized under
2087 42 C.F.R. part 405, subpart U; or providers certified under 42
2088 C.F.R. part 485, subpart B or subpart H; or any entity that
2089 provides neonatal or pediatric hospital-based health care
2090 services or other health care services by licensed practitioners
2091 solely within a hospital licensed under chapter 395.
2092 (b) Entities that own, directly or indirectly, entities
2093 licensed or registered by the state pursuant to chapter 395; or
2094 entities that own, directly or indirectly, entities licensed or
2095 registered by the state and providing only health care services
2096 within the scope of services authorized pursuant to their
2097 respective licenses granted under ss. 383.30-383.335, chapter
2098 390, chapter 394, chapter 397, this chapter except part X,
2099 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
2100 part I of chapter 483, chapter 484, chapter 651; end-stage renal
2101 disease providers authorized under 42 C.F.R. part 405, subpart
2102 U; or providers certified under 42 C.F.R. part 485, subpart B or
2103 subpart H; or any entity that provides neonatal or pediatric
2104 hospital-based health care services by licensed practitioners
2105 solely within a hospital licensed under chapter 395.
2106 (c) Entities that are owned, directly or indirectly, by an
2107 entity licensed or registered by the state pursuant to chapter
2108 395; or entities that are owned, directly or indirectly, by an
2109 entity licensed or registered by the state and providing only
2110 health care services within the scope of services authorized
2111 pursuant to their respective licenses granted under ss. 383.30
2112 383.335, chapter 390, chapter 394, chapter 397, this chapter
2113 except part X, chapter 429, chapter 463, chapter 465, chapter
2114 466, chapter 478, part I of chapter 483, chapter 484, or chapter
2115 651; end-stage renal disease providers authorized under 42
2116 C.F.R. part 405, subpart U; or providers certified under 42
2117 C.F.R. part 485, subpart B or subpart H; or any entity that
2118 provides neonatal or pediatric hospital-based health care
2119 services by licensed practitioners solely within a hospital
2120 under chapter 395.
2121 (d) Entities that are under common ownership, directly or
2122 indirectly, with an entity licensed or registered by the state
2123 pursuant to chapter 395; or entities that are under common
2124 ownership, directly or indirectly, with an entity licensed or
2125 registered by the state and providing only health care services
2126 within the scope of services authorized pursuant to their
2127 respective licenses granted under ss. 383.30-383.335, chapter
2128 390, chapter 394, chapter 397, this chapter except part X,
2129 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
2130 part I of chapter 483, chapter 484, or chapter 651; end-stage
2131 renal disease providers authorized under 42 C.F.R. part 405,
2132 subpart U; or providers certified under 42 C.F.R. part 485,
2133 subpart B or subpart H; or any entity that provides neonatal or
2134 pediatric hospital-based health care services by licensed
2135 practitioners solely within a hospital licensed under chapter
2136 395.
2137 (e) An entity that is exempt from federal taxation under 26
2138 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan
2139 under 26 U.S.C. s. 409 that has a board of trustees not less
2140 than two-thirds of which are Florida-licensed health care
2141 practitioners and provides only physical therapy services under
2142 physician orders, any community college or university clinic,
2143 and any entity owned or operated by the federal or state
2144 government, including agencies, subdivisions, or municipalities
2145 thereof.
2146 (f) A sole proprietorship, group practice, partnership, or
2147 corporation that provides health care services by physicians
2148 covered by s. 627.419, that is directly supervised by one or
2149 more of such physicians, and that is wholly owned by one or more
2150 of those physicians or by a physician and the spouse, parent,
2151 child, or sibling of that physician.
2152 (g) A sole proprietorship, group practice, partnership, or
2153 corporation that provides health care services by licensed
2154 health care practitioners under chapter 457, chapter 458,
2155 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
2156 chapter 466, chapter 467, chapter 480, chapter 484, chapter 486,
2157 chapter 490, chapter 491, or part I, part III, part X, part
2158 XIII, or part XIV of chapter 468, or s. 464.012, which are
2159 wholly owned by one or more licensed health care practitioners,
2160 or the licensed health care practitioners set forth in this
2161 paragraph and the spouse, parent, child, or sibling of a
2162 licensed health care practitioner, so long as one of the owners
2163 who is a licensed health care practitioner is supervising the
2164 business activities and is legally responsible for the entity’s
2165 compliance with all federal and state laws. However, a health
2166 care practitioner may not supervise services beyond the scope of
2167 the practitioner’s license, except that, for the purposes of
2168 this part, a clinic owned by a licensee in s. 456.053(3)(b) that
2169 provides only services authorized pursuant to s. 456.053(3)(b)
2170 may be supervised by a licensee specified in s. 456.053(3)(b).
2171 (h) Clinical facilities affiliated with an accredited
2172 medical school at which training is provided for medical
2173 students, residents, or fellows.
2174 (i) Entities that provide only oncology or radiation
2175 therapy services by physicians licensed under chapter 458 or
2176 chapter 459 or entities that provide oncology or radiation
2177 therapy services by physicians licensed under chapter 458 or
2178 chapter 459 which are owned by a corporation whose shares are
2179 publicly traded on a recognized stock exchange.
2180 (j) Clinical facilities affiliated with a college of
2181 chiropractic accredited by the Council on Chiropractic Education
2182 at which training is provided for chiropractic students.
2183 (k) Entities that provide licensed practitioners to staff
2184 emergency departments or to deliver anesthesia services in
2185 facilities licensed under chapter 395 and that derive at least
2186 90 percent of their gross annual revenues from the provision of
2187 such services. Entities claiming an exemption from licensure
2188 under this paragraph must provide documentation demonstrating
2189 compliance.
2190 (l) Orthotic, or prosthetic, pediatric cardiology,
2191 perinatology, or anesthesia clinical facilities that are a
2192 publicly traded corporation or that are wholly owned, directly
2193 or indirectly, by a publicly traded corporation. As used in this
2194 paragraph, a publicly traded corporation is a corporation that
2195 issues securities traded on an exchange registered with the
2196 United States Securities and Exchange Commission as a national
2197 securities exchange.
2198 (m) Entities that are owned by a corporation that has $250
2199 million or more in total annual sales of health care services
2200 provided by licensed health care practitioners when one or more
2201 of the owners of the entity is a health care practitioner who is
2202 licensed in this state, is responsible for supervising the
2203 business activities of the entity, and is legally responsible
2204 for the entity’s compliance with state law for purposes of this
2205 section.
2206 (n) Entities that are owned or controlled, directly or
2207 indirectly, by a publicly traded entity with $100 million or
2208 more, in the aggregate, in total annual revenues derived from
2209 providing health care services by licensed health care
2210 practitioners that are employed or contracted by an entity
2211 described in this paragraph.
2212 (o) Entities that employ 50 or more licensed health care
2213 practitioners licensed under chapter 458 or chapter 459 when the
2214 billing for medical services is under a single tax
2215 identification number. The application for exemption from
2216 licensure requirements under this paragraph shall contain the
2217 name, residence address, business address, and phone numbers of
2218 the entity that owns the clinic; a complete list of the names
2219 and contact information of all the officers and directors of the
2220 corporation; the name, residence address, business address, and
2221 medical practitioner license number of each health care
2222 practitioner employed by the entity; the corporate tax
2223 identification number of the entity seeking an exemption; a
2224 listing of health care services to be provided by the entity at
2225 the health care clinics owned or operated by the entity; and a
2226 certified statement prepared by an independent certified public
2227 accountant which states that the entity and the health care
2228 clinics owned or operated by the entity have not received
2229 payment for health care services under personal injury
2230 protection insurance coverage for the preceding year. If the
2231 agency determines that an entity that is exempt under this
2232 paragraph has received payments for medical services under
2233 personal injury protection insurance coverage, the agency may
2234 deny or revoke the exemption from licensure under this
2235 paragraph.
2236 (7) “Portable health service or equipment provider” means
2237 an entity that contracts with or employs persons to provide
2238 portable health services or equipment to multiple locations
2239 performing treatment or diagnostic testing of individuals, that
2240 bills third-party payors for those services, and that otherwise
2241 meets the definition of a clinic in subsection (4).
2242 Section 54. Paragraph (b) of subsection (1) and subsection
2243 (4) of section 400.991, Florida Statutes, are amended to read:
2244 400.991 License requirements; background screenings;
2245 prohibitions.—
2246 (1)
2247 (b) Each mobile clinic must obtain a separate health care
2248 clinic license and must provide to the agency, at least
2249 quarterly, its projected street location to enable the agency to
2250 locate and inspect such clinic. A portable health service or
2251 equipment provider must obtain a health care clinic license for
2252 a single administrative office and is not required to submit
2253 quarterly projected street locations.
2254 (4) In addition to the requirements of part II of chapter
2255 408, the applicant must file with the application satisfactory
2256 proof that the clinic is in compliance with this part and
2257 applicable rules, including:
2258 (a) A listing of services to be provided either directly by
2259 the applicant or through contractual arrangements with existing
2260 providers;
2261 (b) The number and discipline of each professional staff
2262 member to be employed; and
2263 (c) Proof of financial ability to operate as required under
2264 ss. s. 408.810(8) and 408.8065. As an alternative to submitting
2265 proof of financial ability to operate as required under s.
2266 408.810(8), the applicant may file a surety bond of at least
2267 $500,000 which guarantees that the clinic will act in full
2268 conformity with all legal requirements for operating a clinic,
2269 payable to the agency. The agency may adopt rules to specify
2270 related requirements for such surety bond.
2271 Section 55. Paragraph (g) of subsection (1) and paragraph
2272 (a) of subsection (7) of section 400.9935, Florida Statutes, are
2273 amended to read:
2274 400.9935 Clinic responsibilities.—
2275 (1) Each clinic shall appoint a medical director or clinic
2276 director who shall agree in writing to accept legal
2277 responsibility for the following activities on behalf of the
2278 clinic. The medical director or the clinic director shall:
2279 (g) Conduct systematic reviews of clinic billings to ensure
2280 that the billings are not fraudulent or unlawful. Upon discovery
2281 of an unlawful charge, the medical director or clinic director
2282 shall take immediate corrective action. If the clinic performs
2283 only the technical component of magnetic resonance imaging,
2284 static radiographs, computed tomography, or positron emission
2285 tomography, and provides the professional interpretation of such
2286 services, in a fixed facility that is accredited by the Joint
2287 Commission on Accreditation of Healthcare Organizations or the
2288 Accreditation Association for Ambulatory Health Care, and the
2289 American College of Radiology; and if, in the preceding quarter,
2290 the percentage of scans performed by that clinic which was
2291 billed to all personal injury protection insurance carriers was
2292 less than 15 percent, the chief financial officer of the clinic
2293 may, in a written acknowledgment provided to the agency, assume
2294 the responsibility for the conduct of the systematic reviews of
2295 clinic billings to ensure that the billings are not fraudulent
2296 or unlawful.
2297 (7)(a) Each clinic engaged in magnetic resonance imaging
2298 services must be accredited by the Joint Commission on
2299 Accreditation of Healthcare Organizations, the American College
2300 of Radiology, or the Accreditation Association for Ambulatory
2301 Health Care, within 1 year after licensure. A clinic that is
2302 accredited by the American College of Radiology or is within the
2303 original 1-year period after licensure and replaces its core
2304 magnetic resonance imaging equipment shall be given 1 year after
2305 the date on which the equipment is replaced to attain
2306 accreditation. However, a clinic may request a single, 6-month
2307 extension if it provides evidence to the agency establishing
2308 that, for good cause shown, such clinic cannot be accredited
2309 within 1 year after licensure, and that such accreditation will
2310 be completed within the 6-month extension. After obtaining
2311 accreditation as required by this subsection, each such clinic
2312 must maintain accreditation as a condition of renewal of its
2313 license. A clinic that files a change of ownership application
2314 must comply with the original accreditation timeframe
2315 requirements of the transferor. The agency shall deny a change
2316 of ownership application if the clinic is not in compliance with
2317 the accreditation requirements. When a clinic adds, replaces, or
2318 modifies magnetic resonance imaging equipment and the
2319 accreditation agency requires new accreditation, the clinic must
2320 be accredited within 1 year after the date of the addition,
2321 replacement, or modification but may request a single, 6-month
2322 extension if the clinic provides evidence of good cause to the
2323 agency.
2324 Section 56. Paragraph (a) of subsection (2) of section
2325 408.033, Florida Statutes, is amended to read:
2326 408.033 Local and state health planning.—
2327 (2) FUNDING.—
2328 (a) The Legislature intends that the cost of local health
2329 councils be borne by assessments on selected health care
2330 facilities subject to facility licensure by the Agency for
2331 Health Care Administration, including abortion clinics, assisted
2332 living facilities, ambulatory surgical centers, birthing
2333 centers, clinical laboratories except community nonprofit blood
2334 banks and clinical laboratories operated by practitioners for
2335 exclusive use regulated under s. 483.035, home health agencies,
2336 hospices, hospitals, intermediate care facilities for the
2337 developmentally disabled, nursing homes, health care clinics,
2338 and multiphasic testing centers and by assessments on
2339 organizations subject to certification by the agency pursuant to
2340 chapter 641, part III, including health maintenance
2341 organizations and prepaid health clinics. Fees assessed may be
2342 collected prospectively at the time of licensure renewal and
2343 prorated for the licensure period.
2344 Section 57. Subsection (2) of section 408.034, Florida
2345 Statutes, is amended to read:
2346 408.034 Duties and responsibilities of agency; rules.—
2347 (2) In the exercise of its authority to issue licenses to
2348 health care facilities and health service providers, as provided
2349 under chapters 393 and 395 and parts II, and IV, and VIII of
2350 chapter 400, the agency may not issue a license to any health
2351 care facility or health service provider that fails to receive a
2352 certificate of need or an exemption for the licensed facility or
2353 service.
2354 Section 58. Paragraph (d) of subsection (1) of section
2355 408.036, Florida Statutes, is amended to read:
2356 408.036 Projects subject to review; exemptions.—
2357 (1) APPLICABILITY.—Unless exempt under subsection (3), all
2358 health-care-related projects, as described in paragraphs (a)
2359 (g), are subject to review and must file an application for a
2360 certificate of need with the agency. The agency is exclusively
2361 responsible for determining whether a health-care-related
2362 project is subject to review under ss. 408.031-408.045.
2363 (d) The establishment of a hospice or hospice inpatient
2364 facility, except as provided in s. 408.043.
2365 Section 59. Paragraph (c) of subsection (1) of section
2366 408.037, Florida Statutes, is amended to read:
2367 408.037 Application content.—
2368 (1) Except as provided in subsection (2) for a general
2369 hospital, an application for a certificate of need must contain:
2370 (c) An audited financial statement of the applicant or the
2371 applicant’s parent corporation if audited financial statements
2372 of the applicant do not exist. In an application submitted by an
2373 existing health care facility, health maintenance organization,
2374 or hospice, financial condition documentation must include, but
2375 need not be limited to, a balance sheet and a profit-and-loss
2376 statement of the 2 previous fiscal years’ operation.
2377 Section 60. Subsection (2) of section 408.043, Florida
2378 Statutes, is amended to read:
2379 408.043 Special provisions.—
2380 (2) HOSPICES.—When an application is made for a certificate
2381 of need to establish or to expand a hospice, the need for such
2382 hospice shall be determined on the basis of the need for and
2383 availability of hospice services in the community. The formula
2384 on which the certificate of need is based shall discourage
2385 regional monopolies and promote competition. The inpatient
2386 hospice care component of a hospice which is a freestanding
2387 facility, or a part of a facility, which is primarily engaged in
2388 providing inpatient care and related services and is not
2389 licensed as a health care facility shall also be required to
2390 obtain a certificate of need. Provision of hospice care by any
2391 current provider of health care is a significant change in
2392 service and therefore requires a certificate of need for such
2393 services.
2394 Section 61. Paragraph (k) of subsection (3) of section
2395 408.05, Florida Statutes, is amended to read:
2396 408.05 Florida Center for Health Information and Policy
2397 Analysis.—
2398 (3) COMPREHENSIVE HEALTH INFORMATION SYSTEM.—In order to
2399 produce comparable and uniform health information and statistics
2400 for the development of policy recommendations, the agency shall
2401 perform the following functions:
2402 (k) Develop, in conjunction with the State Consumer Health
2403 Information and Policy Advisory Council, and implement a long
2404 range plan for making available health care quality measures and
2405 financial data that will allow consumers to compare health care
2406 services. The health care quality measures and financial data
2407 the agency must make available shall include, but is not limited
2408 to, pharmaceuticals, physicians, health care facilities, and
2409 health plans and managed care entities. The agency shall update
2410 the plan and report on the status of its implementation
2411 annually. The agency shall also make the plan and status report
2412 available to the public on its Internet website. As part of the
2413 plan, the agency shall identify the process and timeframes for
2414 implementation, any barriers to implementation, and
2415 recommendations of changes in the law that may be enacted by the
2416 Legislature to eliminate the barriers. As preliminary elements
2417 of the plan, the agency shall:
2418 1. Make available patient-safety indicators, inpatient
2419 quality indicators, and performance outcome and patient charge
2420 data collected from health care facilities pursuant to s.
2421 408.061(1)(a) and (2). The terms “patient-safety indicators” and
2422 “inpatient quality indicators” shall be as defined by the
2423 Centers for Medicare and Medicaid Services, the National Quality
2424 Forum, the Joint Commission on Accreditation of Healthcare
2425 Organizations, the Agency for Healthcare Research and Quality,
2426 the Centers for Disease Control and Prevention, or a similar
2427 national entity that establishes standards to measure the
2428 performance of health care providers, or by other states. The
2429 agency shall determine which conditions, procedures, health care
2430 quality measures, and patient charge data to disclose based upon
2431 input from the council. When determining which conditions and
2432 procedures are to be disclosed, the council and the agency shall
2433 consider variation in costs, variation in outcomes, and
2434 magnitude of variations and other relevant information. When
2435 determining which health care quality measures to disclose, the
2436 agency:
2437 a. Shall consider such factors as volume of cases; average
2438 patient charges; average length of stay; complication rates;
2439 mortality rates; and infection rates, among others, which shall
2440 be adjusted for case mix and severity, if applicable.
2441 b. May consider such additional measures that are adopted
2442 by the Centers for Medicare and Medicaid Studies, National
2443 Quality Forum, the Joint Commission on Accreditation of
2444 Healthcare Organizations, the Agency for Healthcare Research and
2445 Quality, Centers for Disease Control and Prevention, or a
2446 similar national entity that establishes standards to measure
2447 the performance of health care providers, or by other states.
2448
2449 When determining which patient charge data to disclose, the
2450 agency shall include such measures as the average of
2451 undiscounted charges on frequently performed procedures and
2452 preventive diagnostic procedures, the range of procedure charges
2453 from highest to lowest, average net revenue per adjusted patient
2454 day, average cost per adjusted patient day, and average cost per
2455 admission, among others.
2456 2. Make available performance measures, benefit design, and
2457 premium cost data from health plans licensed pursuant to chapter
2458 627 or chapter 641. The agency shall determine which health care
2459 quality measures and member and subscriber cost data to
2460 disclose, based upon input from the council. When determining
2461 which data to disclose, the agency shall consider information
2462 that may be required by either individual or group purchasers to
2463 assess the value of the product, which may include membership
2464 satisfaction, quality of care, current enrollment or membership,
2465 coverage areas, accreditation status, premium costs, plan costs,
2466 premium increases, range of benefits, copayments and
2467 deductibles, accuracy and speed of claims payment, credentials
2468 of physicians, number of providers, names of network providers,
2469 and hospitals in the network. Health plans shall make available
2470 to the agency any such data or information that is not currently
2471 reported to the agency or the office.
2472 3. Determine the method and format for public disclosure of
2473 data reported pursuant to this paragraph. The agency shall make
2474 its determination based upon input from the State Consumer
2475 Health Information and Policy Advisory Council. At a minimum,
2476 the data shall be made available on the agency’s Internet
2477 website in a manner that allows consumers to conduct an
2478 interactive search that allows them to view and compare the
2479 information for specific providers. The website must include
2480 such additional information as is determined necessary to ensure
2481 that the website enhances informed decisionmaking among
2482 consumers and health care purchasers, which shall include, at a
2483 minimum, appropriate guidance on how to use the data and an
2484 explanation of why the data may vary from provider to provider.
2485 4. Publish on its website undiscounted charges for no fewer
2486 than 150 of the most commonly performed adult and pediatric
2487 procedures, including outpatient, inpatient, diagnostic, and
2488 preventative procedures.
2489 Section 62. Paragraph (a) of subsection (1) of section
2490 408.061, Florida Statutes, is amended to read:
2491 408.061 Data collection; uniform systems of financial
2492 reporting; information relating to physician charges;
2493 confidential information; immunity.—
2494 (1) The agency shall require the submission by health care
2495 facilities, health care providers, and health insurers of data
2496 necessary to carry out the agency’s duties. Specifications for
2497 data to be collected under this section shall be developed by
2498 the agency with the assistance of technical advisory panels
2499 including representatives of affected entities, consumers,
2500 purchasers, and such other interested parties as may be
2501 determined by the agency.
2502 (a) Data submitted by health care facilities, including the
2503 facilities as defined in chapter 395, shall include, but are not
2504 limited to: case-mix data, patient admission and discharge data,
2505 hospital emergency department data which shall include the
2506 number of patients treated in the emergency department of a
2507 licensed hospital reported by patient acuity level, data on
2508 hospital-acquired infections as specified by rule, data on
2509 complications as specified by rule, data on readmissions as
2510 specified by rule, with patient and provider-specific
2511 identifiers included, actual charge data by diagnostic groups,
2512 financial data, accounting data, operating expenses, expenses
2513 incurred for rendering services to patients who cannot or do not
2514 pay, interest charges, depreciation expenses based on the
2515 expected useful life of the property and equipment involved, and
2516 demographic data. The agency shall adopt nationally recognized
2517 risk adjustment methodologies or software consistent with the
2518 standards of the Agency for Healthcare Research and Quality and
2519 as selected by the agency for all data submitted as required by
2520 this section. Data may be obtained from documents such as, but
2521 not limited to: leases, contracts, debt instruments, itemized
2522 patient bills, medical record abstracts, and related diagnostic
2523 information. Reported data elements shall be reported
2524 electronically and in accordance with rule 59E-7.012, Florida
2525 Administrative Code. Data submitted shall be certified by the
2526 chief executive officer or an appropriate and duly authorized
2527 representative or employee of the licensed facility that the
2528 information submitted is true and accurate.
2529 Section 63. Subsection (43) of section 408.07, Florida
2530 Statutes, is amended to read:
2531 408.07 Definitions.—As used in this chapter, with the
2532 exception of ss. 408.031-408.045, the term:
2533 (43) “Rural hospital” means an acute care hospital licensed
2534 under chapter 395, having 100 or fewer licensed beds and an
2535 emergency room, and which is:
2536 (a) The sole provider within a county with a population
2537 density of no greater than 100 persons per square mile;
2538 (b) An acute care hospital, in a county with a population
2539 density of no greater than 100 persons per square mile, which is
2540 at least 30 minutes of travel time, on normally traveled roads
2541 under normal traffic conditions, from another acute care
2542 hospital within the same county;
2543 (c) A hospital supported by a tax district or subdistrict
2544 whose boundaries encompass a population of 100 persons or fewer
2545 per square mile;
2546 (d) A hospital with a service area that has a population of
2547 100 persons or fewer per square mile. As used in this paragraph,
2548 the term “service area” means the fewest number of zip codes
2549 that account for 75 percent of the hospital’s discharges for the
2550 most recent 5-year period, based on information available from
2551 the hospital inpatient discharge database in the Florida Center
2552 for Health Information and Policy Analysis at the Agency for
2553 Health Care Administration; or
2554 (e) A critical access hospital.
2555
2556 Population densities used in this subsection must be based upon
2557 the most recently completed United States census. A hospital
2558 that received funds under s. 409.9116 for a quarter beginning no
2559 later than July 1, 2002, is deemed to have been and shall
2560 continue to be a rural hospital from that date through June 30,
2561 2015, if the hospital continues to have 100 or fewer licensed
2562 beds and an emergency room, or meets the criteria of s.
2563 395.602(2)(e)4. An acute care hospital that has not previously
2564 been designated as a rural hospital and that meets the criteria
2565 of this subsection shall be granted such designation upon
2566 application, including supporting documentation, to the Agency
2567 for Health Care Administration.
2568 Section 64. Section 408.10, Florida Statutes, is amended to
2569 read:
2570 408.10 Consumer complaints.—The agency shall:
2571 (1) publish and make available to the public a toll-free
2572 telephone number for the purpose of handling consumer complaints
2573 and shall serve as a liaison between consumer entities and other
2574 private entities and governmental entities for the disposition
2575 of problems identified by consumers of health care.
2576 (2) Be empowered to investigate consumer complaints
2577 relating to problems with health care facilities’ billing
2578 practices and issue reports to be made public in any cases where
2579 the agency determines the health care facility has engaged in
2580 billing practices which are unreasonable and unfair to the
2581 consumer.
2582 Section 65. Subsections (12) through (30) of section
2583 408.802, Florida Statutes, are renumbered as subsections (11)
2584 through (29), respectively, and present subsection (11) of that
2585 section is amended, to read:
2586 408.802 Applicability.—The provisions of this part apply to
2587 the provision of services that require licensure as defined in
2588 this part and to the following entities licensed, registered, or
2589 certified by the agency, as described in chapters 112, 383, 390,
2590 394, 395, 400, 429, 440, 483, and 765:
2591 (11) Private review agents, as provided under part I of
2592 chapter 395.
2593 Section 66. Subsection (3) is added to section 408.804,
2594 Florida Statutes, to read:
2595 408.804 License required; display.—
2596 (3) Any person who knowingly alters, defaces, or falsifies
2597 a license certificate issued by the agency, or causes or
2598 procures any person to commit such an offense, commits a
2599 misdemeanor of the second degree, punishable as provided in s.
2600 775.082 or s. 775.083. Any licensee or provider who displays an
2601 altered, defaced, or falsified license certificate is subject to
2602 the penalties set forth in s. 408.815 and an administrative fine
2603 of $1,000 for each day of illegal display.
2604 Section 67. Paragraph (d) of subsection (2) of section
2605 408.806, Florida Statutes, is amended, and paragraph (e) is
2606 added to that subsection, to read:
2607 408.806 License application process.—
2608 (2)
2609 (d) The agency shall notify the licensee by mail or
2610 electronically at least 90 days before the expiration of a
2611 license that a renewal license is necessary to continue
2612 operation. The licensee’s failure to timely file submit a
2613 renewal application and license application fee with the agency
2614 shall result in a $50 per day late fee charged to the licensee
2615 by the agency; however, the aggregate amount of the late fee may
2616 not exceed 50 percent of the licensure fee or $500, whichever is
2617 less. The agency shall provide a courtesy notice to the licensee
2618 by United States mail, electronically, or by any other manner at
2619 its address of record or mailing address, if provided, at least
2620 90 days before the expiration of a license. This courtesy notice
2621 must inform the licensee of the expiration of the license. If
2622 the agency does not provide the courtesy notice or the licensee
2623 does not receive the courtesy notice, the licensee continues to
2624 be legally obligated to timely file the renewal application and
2625 license application fee with the agency and is not excused from
2626 the payment of a late fee. If an application is received after
2627 the required filing date and exhibits a hand-canceled postmark
2628 obtained from a United States post office dated on or before the
2629 required filing date, no fine will be levied.
2630 (e) The applicant must pay the late fee before a late
2631 application is considered complete and failure to pay the late
2632 fee is considered an omission from the application for licensure
2633 pursuant to paragraph (3)(b).
2634 Section 68. Paragraph (b) of subsection (1) of section
2635 408.8065, Florida Statutes, is amended to read:
2636 408.8065 Additional licensure requirements for home health
2637 agencies, home medical equipment providers, and health care
2638 clinics.—
2639 (1) An applicant for initial licensure, or initial
2640 licensure due to a change of ownership, as a home health agency,
2641 home medical equipment provider, or health care clinic shall:
2642 (b) Submit projected pro forma financial statements,
2643 including a balance sheet, income and expense statement, and a
2644 statement of cash flows for the first 2 years of operation which
2645 provide evidence that the applicant has sufficient assets,
2646 credit, and projected revenues to cover liabilities and
2647 expenses.
2648
2649 All documents required under this subsection must be prepared in
2650 accordance with generally accepted accounting principles and may
2651 be in a compilation form. The financial statements must be
2652 signed by a certified public accountant.
2653 Section 69. Section 408.809, Florida Statutes, is amended
2654 to read:
2655 408.809 Background screening; prohibited offenses.—
2656 (1) Level 2 background screening pursuant to chapter 435
2657 must be conducted through the agency on each of the following
2658 persons, who are considered employees for the purposes of
2659 conducting screening under chapter 435:
2660 (a) The licensee, if an individual.
2661 (b) The administrator or a similarly titled person who is
2662 responsible for the day-to-day operation of the provider.
2663 (c) The financial officer or similarly titled individual
2664 who is responsible for the financial operation of the licensee
2665 or provider.
2666 (d) Any person who is a controlling interest if the agency
2667 has reason to believe that such person has been convicted of any
2668 offense prohibited by s. 435.04. For each controlling interest
2669 who has been convicted of any such offense, the licensee shall
2670 submit to the agency a description and explanation of the
2671 conviction at the time of license application.
2672 (e) Any person, as required by authorizing statutes,
2673 seeking employment with a licensee or provider who is expected
2674 to, or whose responsibilities may require him or her to, provide
2675 personal care or services directly to clients or have access to
2676 client funds, personal property, or living areas; and any
2677 person, as required by authorizing statutes, contracting with a
2678 licensee or provider whose responsibilities require him or her
2679 to provide personal care or personal services directly to
2680 clients. Evidence of contractor screening may be retained by the
2681 contractor’s employer or the licensee.
2682 (2) Every 5 years following his or her licensure,
2683 employment, or entry into a contract in a capacity that under
2684 subsection (1) would require level 2 background screening under
2685 chapter 435, each such person must submit to level 2 background
2686 rescreening as a condition of retaining such license or
2687 continuing in such employment or contractual status. For any
2688 such rescreening, the agency shall request the Department of Law
2689 Enforcement to forward the person’s fingerprints to the Federal
2690 Bureau of Investigation for a national criminal history record
2691 check. If the fingerprints of such a person are not retained by
2692 the Department of Law Enforcement under s. 943.05(2)(g), the
2693 person must file a complete set of fingerprints with the agency
2694 and the agency shall forward the fingerprints to the Department
2695 of Law Enforcement for state processing, and the Department of
2696 Law Enforcement shall forward the fingerprints to the Federal
2697 Bureau of Investigation for a national criminal history record
2698 check. The fingerprints may be retained by the Department of Law
2699 Enforcement under s. 943.05(2)(g). The cost of the state and
2700 national criminal history records checks required by level 2
2701 screening may be borne by the licensee or the person
2702 fingerprinted. Proof of compliance with level 2 screening
2703 standards submitted within the previous 5 years to meet any
2704 provider or professional licensure requirements of the agency,
2705 the Department of Health, the Agency for Persons with
2706 Disabilities, the Department of Children and Family Services, or
2707 the Department of Financial Services for an applicant for a
2708 certificate of authority or provisional certificate of authority
2709 to operate a continuing care retirement community under chapter
2710 651 satisfies the requirements of this section if the person
2711 subject to screening has not been unemployed for more than 90
2712 days and such proof is accompanied, under penalty of perjury, by
2713 an affidavit of compliance with the provisions of chapter 435
2714 and this section using forms provided by the agency.
2715 (3) All fingerprints must be provided in electronic format.
2716 Screening results shall be reviewed by the agency with respect
2717 to the offenses specified in s. 435.04 and this section, and the
2718 qualifying or disqualifying status of the person named in the
2719 request shall be maintained in a database. The qualifying or
2720 disqualifying status of the person named in the request shall be
2721 posted on a secure website for retrieval by the licensee or
2722 designated agent on the licensee’s behalf.
2723 (4) In addition to the offenses listed in s. 435.04, all
2724 persons required to undergo background screening pursuant to
2725 this part or authorizing statutes must not have an arrest
2726 awaiting final disposition for, must not have been found guilty
2727 of, regardless of adjudication, or entered a plea of nolo
2728 contendere or guilty to, and must not have been adjudicated
2729 delinquent and the record not have been sealed or expunged for
2730 any of the following offenses or any similar offense of another
2731 jurisdiction:
2732 (a) Any authorizing statutes, if the offense was a felony.
2733 (b) This chapter, if the offense was a felony.
2734 (c) Section 409.920, relating to Medicaid provider fraud.
2735 (d) Section 409.9201, relating to Medicaid fraud.
2736 (e) Section 741.28, relating to domestic violence.
2737 (f) Section 817.034, relating to fraudulent acts through
2738 mail, wire, radio, electromagnetic, photoelectronic, or
2739 photooptical systems.
2740 (g) Section 817.234, relating to false and fraudulent
2741 insurance claims.
2742 (h) Section 817.505, relating to patient brokering.
2743 (i) Section 817.568, relating to criminal use of personal
2744 identification information.
2745 (j) Section 817.60, relating to obtaining a credit card
2746 through fraudulent means.
2747 (k) Section 817.61, relating to fraudulent use of credit
2748 cards, if the offense was a felony.
2749 (l) Section 831.01, relating to forgery.
2750 (m) Section 831.02, relating to uttering forged
2751 instruments.
2752 (n) Section 831.07, relating to forging bank bills, checks,
2753 drafts, or promissory notes.
2754 (o) Section 831.09, relating to uttering forged bank bills,
2755 checks, drafts, or promissory notes.
2756 (p) Section 831.30, relating to fraud in obtaining
2757 medicinal drugs.
2758 (q) Section 831.31, relating to the sale, manufacture,
2759 delivery, or possession with the intent to sell, manufacture, or
2760 deliver any counterfeit controlled substance, if the offense was
2761 a felony.
2762 (5) A person who serves as a controlling interest of, is
2763 employed by, or contracts with a licensee on July 31, 2010, who
2764 has been screened and qualified according to standards specified
2765 in s. 435.03 or s. 435.04 must be rescreened by July 31, 2015,
2766 in accordance with the schedule provided in paragraphs (a)-(c).
2767 The agency may adopt rules to establish a schedule to stagger
2768 the implementation of the required rescreening over the 5-year
2769 period, beginning July 31, 2010, through July 31, 2015. If, upon
2770 rescreening, such person has a disqualifying offense that was
2771 not a disqualifying offense at the time of the last screening,
2772 but is a current disqualifying offense and was committed before
2773 the last screening, he or she may apply for an exemption from
2774 the appropriate licensing agency and, if agreed to by the
2775 employer, may continue to perform his or her duties until the
2776 licensing agency renders a decision on the application for
2777 exemption if the person is eligible to apply for an exemption
2778 and the exemption request is received by the agency within 30
2779 days after receipt of the rescreening results by the person. The
2780 rescreening schedule shall be as follows:
2781 (a) Individuals whose last screening was conducted before
2782 December 31, 2003, must be rescreened by July 31, 2013.
2783 (b) Individuals whose last screening was conducted between
2784 January 1, 2004, through December 31, 2007, must be rescreened
2785 by July 31, 2014.
2786 (c) Individuals whose last screening was conducted between
2787 January 1, 2008, through July 31, 2010, must be rescreened by
2788 July 31, 2015.
2789 (6)(5) The costs associated with obtaining the required
2790 screening must be borne by the licensee or the person subject to
2791 screening. Licensees may reimburse persons for these costs. The
2792 Department of Law Enforcement shall charge the agency for
2793 screening pursuant to s. 943.053(3). The agency shall establish
2794 a schedule of fees to cover the costs of screening.
2795 (7)(6)(a) As provided in chapter 435, the agency may grant
2796 an exemption from disqualification to a person who is subject to
2797 this section and who:
2798 1. Does not have an active professional license or
2799 certification from the Department of Health; or
2800 2. Has an active professional license or certification from
2801 the Department of Health but is not providing a service within
2802 the scope of that license or certification.
2803 (b) As provided in chapter 435, the appropriate regulatory
2804 board within the Department of Health, or the department itself
2805 if there is no board, may grant an exemption from
2806 disqualification to a person who is subject to this section and
2807 who has received a professional license or certification from
2808 the Department of Health or a regulatory board within that
2809 department and that person is providing a service within the
2810 scope of his or her licensed or certified practice.
2811 (8)(7) The agency and the Department of Health may adopt
2812 rules pursuant to ss. 120.536(1) and 120.54 to implement this
2813 section, chapter 435, and authorizing statutes requiring
2814 background screening and to implement and adopt criteria
2815 relating to retaining fingerprints pursuant to s. 943.05(2).
2816 (9)(8) There is no unemployment compensation or other
2817 monetary liability on the part of, and no cause of action for
2818 damages arising against, an employer that, upon notice of a
2819 disqualifying offense listed under chapter 435 or this section,
2820 terminates the person against whom the report was issued,
2821 whether or not that person has filed for an exemption with the
2822 Department of Health or the agency.
2823 Section 70. Subsection (9) of section 408.810, Florida
2824 Statutes, is amended to read:
2825 408.810 Minimum licensure requirements.—In addition to the
2826 licensure requirements specified in this part, authorizing
2827 statutes, and applicable rules, each applicant and licensee must
2828 comply with the requirements of this section in order to obtain
2829 and maintain a license.
2830 (9) A controlling interest may not withhold from the agency
2831 any evidence of financial instability, including, but not
2832 limited to, checks returned due to insufficient funds,
2833 delinquent accounts, nonpayment of withholding taxes, unpaid
2834 utility expenses, nonpayment for essential services, or adverse
2835 court action concerning the financial viability of the provider
2836 or any other provider licensed under this part that is under the
2837 control of the controlling interest. A controlling interest
2838 shall notify the agency within 10 days after a court action to
2839 initiate bankruptcy, foreclosure, or eviction proceedings
2840 concerning the provider in which the controlling interest is a
2841 petitioner or defendant. Any person who violates this subsection
2842 commits a misdemeanor of the second degree, punishable as
2843 provided in s. 775.082 or s. 775.083. Each day of continuing
2844 violation is a separate offense.
2845 Section 71. Subsection (3) is added to section 408.813,
2846 Florida Statutes, to read:
2847 408.813 Administrative fines; violations.—As a penalty for
2848 any violation of this part, authorizing statutes, or applicable
2849 rules, the agency may impose an administrative fine.
2850 (3) The agency may impose an administrative fine for a
2851 violation that is not designated as a class I, class II, class
2852 III, or class IV violation. Unless otherwise specified by law,
2853 the amount of the fine may not exceed $500 for each violation.
2854 Unclassified violations include:
2855 (a) Violating any term or condition of a license.
2856 (b) Violating any provision of this part, authorizing
2857 statutes, or applicable rules.
2858 (c) Exceeding licensed capacity.
2859 (d) Providing services beyond the scope of the license.
2860 (e) Violating a moratorium imposed pursuant to s. 408.814.
2861 Section 72. Subsection (37) of section 409.912, Florida
2862 Statutes, is amended to read:
2863 409.912 Cost-effective purchasing of health care.—The
2864 agency shall purchase goods and services for Medicaid recipients
2865 in the most cost-effective manner consistent with the delivery
2866 of quality medical care. To ensure that medical services are
2867 effectively utilized, the agency may, in any case, require a
2868 confirmation or second physician’s opinion of the correct
2869 diagnosis for purposes of authorizing future services under the
2870 Medicaid program. This section does not restrict access to
2871 emergency services or poststabilization care services as defined
2872 in 42 C.F.R. part 438.114. Such confirmation or second opinion
2873 shall be rendered in a manner approved by the agency. The agency
2874 shall maximize the use of prepaid per capita and prepaid
2875 aggregate fixed-sum basis services when appropriate and other
2876 alternative service delivery and reimbursement methodologies,
2877 including competitive bidding pursuant to s. 287.057, designed
2878 to facilitate the cost-effective purchase of a case-managed
2879 continuum of care. The agency shall also require providers to
2880 minimize the exposure of recipients to the need for acute
2881 inpatient, custodial, and other institutional care and the
2882 inappropriate or unnecessary use of high-cost services. The
2883 agency shall contract with a vendor to monitor and evaluate the
2884 clinical practice patterns of providers in order to identify
2885 trends that are outside the normal practice patterns of a
2886 provider’s professional peers or the national guidelines of a
2887 provider’s professional association. The vendor must be able to
2888 provide information and counseling to a provider whose practice
2889 patterns are outside the norms, in consultation with the agency,
2890 to improve patient care and reduce inappropriate utilization.
2891 The agency may mandate prior authorization, drug therapy
2892 management, or disease management participation for certain
2893 populations of Medicaid beneficiaries, certain drug classes, or
2894 particular drugs to prevent fraud, abuse, overuse, and possible
2895 dangerous drug interactions. The Pharmaceutical and Therapeutics
2896 Committee shall make recommendations to the agency on drugs for
2897 which prior authorization is required. The agency shall inform
2898 the Pharmaceutical and Therapeutics Committee of its decisions
2899 regarding drugs subject to prior authorization. The agency is
2900 authorized to limit the entities it contracts with or enrolls as
2901 Medicaid providers by developing a provider network through
2902 provider credentialing. The agency may competitively bid single
2903 source-provider contracts if procurement of goods or services
2904 results in demonstrated cost savings to the state without
2905 limiting access to care. The agency may limit its network based
2906 on the assessment of beneficiary access to care, provider
2907 availability, provider quality standards, time and distance
2908 standards for access to care, the cultural competence of the
2909 provider network, demographic characteristics of Medicaid
2910 beneficiaries, practice and provider-to-beneficiary standards,
2911 appointment wait times, beneficiary use of services, provider
2912 turnover, provider profiling, provider licensure history,
2913 previous program integrity investigations and findings, peer
2914 review, provider Medicaid policy and billing compliance records,
2915 clinical and medical record audits, and other factors. Providers
2916 are not entitled to enrollment in the Medicaid provider network.
2917 The agency shall determine instances in which allowing Medicaid
2918 beneficiaries to purchase durable medical equipment and other
2919 goods is less expensive to the Medicaid program than long-term
2920 rental of the equipment or goods. The agency may establish rules
2921 to facilitate purchases in lieu of long-term rentals in order to
2922 protect against fraud and abuse in the Medicaid program as
2923 defined in s. 409.913. The agency may seek federal waivers
2924 necessary to administer these policies.
2925 (37)(a) The agency shall implement a Medicaid prescribed
2926 drug spending-control program that includes the following
2927 components:
2928 1. A Medicaid preferred drug list, which shall be a listing
2929 of cost-effective therapeutic options recommended by the
2930 Medicaid Pharmacy and Therapeutics Committee established
2931 pursuant to s. 409.91195 and adopted by the agency for each
2932 therapeutic class on the preferred drug list. At the discretion
2933 of the committee, and when feasible, the preferred drug list
2934 should include at least two products in a therapeutic class. The
2935 agency may post the preferred drug list and updates to the list
2936 on an Internet website without following the rulemaking
2937 procedures of chapter 120. Antiretroviral agents are excluded
2938 from the preferred drug list. The agency shall also limit the
2939 amount of a prescribed drug dispensed to no more than a 34-day
2940 supply unless the drug products’ smallest marketed package is
2941 greater than a 34-day supply, or the drug is determined by the
2942 agency to be a maintenance drug in which case a 100-day maximum
2943 supply may be authorized. The agency may seek any federal
2944 waivers necessary to implement these cost-control programs and
2945 to continue participation in the federal Medicaid rebate
2946 program, or alternatively to negotiate state-only manufacturer
2947 rebates. The agency may adopt rules to administer this
2948 subparagraph. The agency shall continue to provide unlimited
2949 contraceptive drugs and items. The agency must establish
2950 procedures to ensure that:
2951 a. There is a response to a request for prior consultation
2952 by telephone or other telecommunication device within 24 hours
2953 after receipt of a request for prior consultation; and
2954 b. A 72-hour supply of the drug prescribed is provided in
2955 an emergency or when the agency does not provide a response
2956 within 24 hours as required by sub-subparagraph a.
2957 2. Reimbursement to pharmacies for Medicaid prescribed
2958 drugs shall be set at the lowest of: the average wholesale price
2959 (AWP) minus 16.4 percent, the wholesaler acquisition cost (WAC)
2960 plus 1.5 percent, the federal upper limit (FUL), the state
2961 maximum allowable cost (SMAC), or the usual and customary (UAC)
2962 charge billed by the provider.
2963 3. The agency shall develop and implement a process for
2964 managing the drug therapies of Medicaid recipients who are using
2965 significant numbers of prescribed drugs each month. The
2966 management process may include, but is not limited to,
2967 comprehensive, physician-directed medical-record reviews, claims
2968 analyses, and case evaluations to determine the medical
2969 necessity and appropriateness of a patient’s treatment plan and
2970 drug therapies. The agency may contract with a private
2971 organization to provide drug-program-management services. The
2972 Medicaid drug benefit management program shall include
2973 initiatives to manage drug therapies for HIV/AIDS patients,
2974 patients using 20 or more unique prescriptions in a 180-day
2975 period, and the top 1,000 patients in annual spending. The
2976 agency shall enroll any Medicaid recipient in the drug benefit
2977 management program if he or she meets the specifications of this
2978 provision and is not enrolled in a Medicaid health maintenance
2979 organization.
2980 4. The agency may limit the size of its pharmacy network
2981 based on need, competitive bidding, price negotiations,
2982 credentialing, or similar criteria. The agency shall give
2983 special consideration to rural areas in determining the size and
2984 location of pharmacies included in the Medicaid pharmacy
2985 network. A pharmacy credentialing process may include criteria
2986 such as a pharmacy’s full-service status, location, size,
2987 patient educational programs, patient consultation, disease
2988 management services, and other characteristics. The agency may
2989 impose a moratorium on Medicaid pharmacy enrollment if it is
2990 determined that it has a sufficient number of Medicaid
2991 participating providers. The agency must allow dispensing
2992 practitioners to participate as a part of the Medicaid pharmacy
2993 network regardless of the practitioner’s proximity to any other
2994 entity that is dispensing prescription drugs under the Medicaid
2995 program. A dispensing practitioner must meet all credentialing
2996 requirements applicable to his or her practice, as determined by
2997 the agency.
2998 5. The agency shall develop and implement a program that
2999 requires Medicaid practitioners who prescribe drugs to use a
3000 counterfeit-proof prescription pad for Medicaid prescriptions.
3001 The agency shall require the use of standardized counterfeit
3002 proof prescription pads by Medicaid-participating prescribers or
3003 prescribers who write prescriptions for Medicaid recipients. The
3004 agency may implement the program in targeted geographic areas or
3005 statewide.
3006 6. The agency may enter into arrangements that require
3007 manufacturers of generic drugs prescribed to Medicaid recipients
3008 to provide rebates of at least 15.1 percent of the average
3009 manufacturer price for the manufacturer’s generic products.
3010 These arrangements shall require that if a generic-drug
3011 manufacturer pays federal rebates for Medicaid-reimbursed drugs
3012 at a level below 15.1 percent, the manufacturer must provide a
3013 supplemental rebate to the state in an amount necessary to
3014 achieve a 15.1-percent rebate level.
3015 7. The agency may establish a preferred drug list as
3016 described in this subsection, and, pursuant to the establishment
3017 of such preferred drug list, negotiate supplemental rebates from
3018 manufacturers that are in addition to those required by Title
3019 XIX of the Social Security Act and at no less than 14 percent of
3020 the average manufacturer price as defined in 42 U.S.C. s. 1936
3021 on the last day of a quarter unless the federal or supplemental
3022 rebate, or both, equals or exceeds 29 percent. There is no upper
3023 limit on the supplemental rebates the agency may negotiate. The
3024 agency may determine that specific products, brand-name or
3025 generic, are competitive at lower rebate percentages. Agreement
3026 to pay the minimum supplemental rebate percentage guarantees a
3027 manufacturer that the Medicaid Pharmaceutical and Therapeutics
3028 Committee will consider a product for inclusion on the preferred
3029 drug list. However, a pharmaceutical manufacturer is not
3030 guaranteed placement on the preferred drug list by simply paying
3031 the minimum supplemental rebate. Agency decisions will be made
3032 on the clinical efficacy of a drug and recommendations of the
3033 Medicaid Pharmaceutical and Therapeutics Committee, as well as
3034 the price of competing products minus federal and state rebates.
3035 The agency may contract with an outside agency or contractor to
3036 conduct negotiations for supplemental rebates. For the purposes
3037 of this section, the term “supplemental rebates” means cash
3038 rebates. Value-added programs as a substitution for supplemental
3039 rebates are prohibited. The agency may seek any federal waivers
3040 to implement this initiative.
3041 8. The agency shall expand home delivery of pharmacy
3042 products. The agency may amend the state plan and issue a
3043 procurement, as necessary, in order to implement this program.
3044 The procurements must include agreements with a pharmacy or
3045 pharmacies located in the state to provide mail order delivery
3046 services at no cost to the recipients who elect to receive home
3047 delivery of pharmacy products. The procurement must focus on
3048 serving recipients with chronic diseases for which pharmacy
3049 expenditures represent a significant portion of Medicaid
3050 pharmacy expenditures or which impact a significant portion of
3051 the Medicaid population. The agency may seek and implement any
3052 federal waivers necessary to implement this subparagraph.
3053 9. The agency shall limit to one dose per month any drug
3054 prescribed to treat erectile dysfunction.
3055 10.a. The agency may implement a Medicaid behavioral drug
3056 management system. The agency may contract with a vendor that
3057 has experience in operating behavioral drug management systems
3058 to implement this program. The agency may seek federal waivers
3059 to implement this program.
3060 b. The agency, in conjunction with the Department of
3061 Children and Family Services, may implement the Medicaid
3062 behavioral drug management system that is designed to improve
3063 the quality of care and behavioral health prescribing practices
3064 based on best practice guidelines, improve patient adherence to
3065 medication plans, reduce clinical risk, and lower prescribed
3066 drug costs and the rate of inappropriate spending on Medicaid
3067 behavioral drugs. The program may include the following
3068 elements:
3069 (I) Provide for the development and adoption of best
3070 practice guidelines for behavioral health-related drugs such as
3071 antipsychotics, antidepressants, and medications for treating
3072 bipolar disorders and other behavioral conditions; translate
3073 them into practice; review behavioral health prescribers and
3074 compare their prescribing patterns to a number of indicators
3075 that are based on national standards; and determine deviations
3076 from best practice guidelines.
3077 (II) Implement processes for providing feedback to and
3078 educating prescribers using best practice educational materials
3079 and peer-to-peer consultation.
3080 (III) Assess Medicaid beneficiaries who are outliers in
3081 their use of behavioral health drugs with regard to the numbers
3082 and types of drugs taken, drug dosages, combination drug
3083 therapies, and other indicators of improper use of behavioral
3084 health drugs.
3085 (IV) Alert prescribers to patients who fail to refill
3086 prescriptions in a timely fashion, are prescribed multiple same
3087 class behavioral health drugs, and may have other potential
3088 medication problems.
3089 (V) Track spending trends for behavioral health drugs and
3090 deviation from best practice guidelines.
3091 (VI) Use educational and technological approaches to
3092 promote best practices, educate consumers, and train prescribers
3093 in the use of practice guidelines.
3094 (VII) Disseminate electronic and published materials.
3095 (VIII) Hold statewide and regional conferences.
3096 (IX) Implement a disease management program with a model
3097 quality-based medication component for severely mentally ill
3098 individuals and emotionally disturbed children who are high
3099 users of care.
3100 11. The agency shall implement a Medicaid prescription drug
3101 management system.
3102 a. The agency may contract with a vendor that has
3103 experience in operating prescription drug management systems in
3104 order to implement this system. Any management system that is
3105 implemented in accordance with this subparagraph must rely on
3106 cooperation between physicians and pharmacists to determine
3107 appropriate practice patterns and clinical guidelines to improve
3108 the prescribing, dispensing, and use of drugs in the Medicaid
3109 program. The agency may seek federal waivers to implement this
3110 program.
3111 b. The drug management system must be designed to improve
3112 the quality of care and prescribing practices based on best
3113 practice guidelines, improve patient adherence to medication
3114 plans, reduce clinical risk, and lower prescribed drug costs and
3115 the rate of inappropriate spending on Medicaid prescription
3116 drugs. The program must:
3117 (I) Provide for the adoption of best practice guidelines
3118 for the prescribing and use of drugs in the Medicaid program,
3119 including translating best practice guidelines into practice;
3120 reviewing prescriber patterns and comparing them to indicators
3121 that are based on national standards and practice patterns of
3122 clinical peers in their community, statewide, and nationally;
3123 and determine deviations from best practice guidelines.
3124 (II) Implement processes for providing feedback to and
3125 educating prescribers using best practice educational materials
3126 and peer-to-peer consultation.
3127 (III) Assess Medicaid recipients who are outliers in their
3128 use of a single or multiple prescription drugs with regard to
3129 the numbers and types of drugs taken, drug dosages, combination
3130 drug therapies, and other indicators of improper use of
3131 prescription drugs.
3132 (IV) Alert prescribers to recipients who fail to refill
3133 prescriptions in a timely fashion, are prescribed multiple drugs
3134 that may be redundant or contraindicated, or may have other
3135 potential medication problems.
3136 12. The agency may contract for drug rebate administration,
3137 including, but not limited to, calculating rebate amounts,
3138 invoicing manufacturers, negotiating disputes with
3139 manufacturers, and maintaining a database of rebate collections.
3140 13. The agency may specify the preferred daily dosing form
3141 or strength for the purpose of promoting best practices with
3142 regard to the prescribing of certain drugs as specified in the
3143 General Appropriations Act and ensuring cost-effective
3144 prescribing practices.
3145 14. The agency may require prior authorization for
3146 Medicaid-covered prescribed drugs. The agency may prior
3147 authorize the use of a product:
3148 a. For an indication not approved in labeling;
3149 b. To comply with certain clinical guidelines; or
3150 c. If the product has the potential for overuse, misuse, or
3151 abuse.
3152
3153 The agency may require the prescribing professional to provide
3154 information about the rationale and supporting medical evidence
3155 for the use of a drug. The agency shall may post prior
3156 authorization and step edit criteria and protocol and updates to
3157 the list of drugs that are subject to prior authorization on the
3158 agency’s an Internet website within 21 days after the prior
3159 authorization and step-edit criteria and protocol and updates
3160 are approved by the agency. For purposes of this subparagraph,
3161 the term “step-edit” means an automatic electronic review of
3162 certain medications subject to prior authorization without
3163 amending its rule or engaging in additional rulemaking.
3164 15. The agency, in conjunction with the Pharmaceutical and
3165 Therapeutics Committee, may require age-related prior
3166 authorizations for certain prescribed drugs. The agency may
3167 preauthorize the use of a drug for a recipient who may not meet
3168 the age requirement or may exceed the length of therapy for use
3169 of this product as recommended by the manufacturer and approved
3170 by the Food and Drug Administration. Prior authorization may
3171 require the prescribing professional to provide information
3172 about the rationale and supporting medical evidence for the use
3173 of a drug.
3174 16. The agency shall implement a step-therapy prior
3175 authorization approval process for medications excluded from the
3176 preferred drug list. Medications listed on the preferred drug
3177 list must be used within the previous 12 months before the
3178 alternative medications that are not listed. The step-therapy
3179 prior authorization may require the prescriber to use the
3180 medications of a similar drug class or for a similar medical
3181 indication unless contraindicated in the Food and Drug
3182 Administration labeling. The trial period between the specified
3183 steps may vary according to the medical indication. The step
3184 therapy approval process shall be developed in accordance with
3185 the committee as stated in s. 409.91195(7) and (8). A drug
3186 product may be approved without meeting the step-therapy prior
3187 authorization criteria if the prescribing physician provides the
3188 agency with additional written medical or clinical documentation
3189 that the product is medically necessary because:
3190 a. There is not a drug on the preferred drug list to treat
3191 the disease or medical condition which is an acceptable clinical
3192 alternative;
3193 b. The alternatives have been ineffective in the treatment
3194 of the beneficiary’s disease; or
3195 c. Based on historic evidence and known characteristics of
3196 the patient and the drug, the drug is likely to be ineffective,
3197 or the number of doses have been ineffective.
3198
3199 The agency shall work with the physician to determine the best
3200 alternative for the patient. The agency may adopt rules waiving
3201 the requirements for written clinical documentation for specific
3202 drugs in limited clinical situations.
3203 17. The agency shall implement a return and reuse program
3204 for drugs dispensed by pharmacies to institutional recipients,
3205 which includes payment of a $5 restocking fee for the
3206 implementation and operation of the program. The return and
3207 reuse program shall be implemented electronically and in a
3208 manner that promotes efficiency. The program must permit a
3209 pharmacy to exclude drugs from the program if it is not
3210 practical or cost-effective for the drug to be included and must
3211 provide for the return to inventory of drugs that cannot be
3212 credited or returned in a cost-effective manner. The agency
3213 shall determine if the program has reduced the amount of
3214 Medicaid prescription drugs which are destroyed on an annual
3215 basis and if there are additional ways to ensure more
3216 prescription drugs are not destroyed which could safely be
3217 reused.
3218 (b) The agency shall implement this subsection to the
3219 extent that funds are appropriated to administer the Medicaid
3220 prescribed-drug spending-control program. The agency may
3221 contract all or any part of this program to private
3222 organizations.
3223 (c) The agency shall submit quarterly reports to the
3224 Governor, the President of the Senate, and the Speaker of the
3225 House of Representatives which must include, but need not be
3226 limited to, the progress made in implementing this subsection
3227 and its effect on Medicaid prescribed-drug expenditures.
3228 Section 73. Subsection (21) is added to section 409.9122,
3229 Florida Statutes, to read:
3230 409.9122 Mandatory Medicaid managed care enrollment;
3231 programs and procedures.—
3232 (21) Until the time of recipient enrollment in plans
3233 selected pursuant to s. 409.966, all hospitals shall be deemed
3234 to be part of a managed care plan’s network in its application
3235 for participation or expansion in the Medicaid program under s.
3236 409.9122. Payment by a managed care plan to such hospitals shall
3237 be in accordance with the provisions of s. 409.975(1)(a). This
3238 subsection expires October 1, 2014, or upon full implementation
3239 of the managed medical assistance program, whichever is sooner.
3240 Section 74. Section 429.11, Florida Statutes, is amended to
3241 read:
3242 429.11 Initial application for license; provisional
3243 license.—
3244 (1) Each applicant for licensure must comply with all
3245 provisions of part II of chapter 408 and must:
3246 (a) Identify all other homes or facilities, including the
3247 addresses and the license or licenses under which they operate,
3248 if applicable, which are currently operated by the applicant or
3249 administrator and which provide housing, meals, and personal
3250 services to residents.
3251 (b) Provide the location of the facility for which a
3252 license is sought and documentation, signed by the appropriate
3253 local government official, which states that the applicant has
3254 met local zoning requirements.
3255 (c) Provide the name, address, date of birth, social
3256 security number, education, and experience of the administrator,
3257 if different from the applicant.
3258 (2) The applicant shall provide proof of liability
3259 insurance as defined in s. 624.605.
3260 (3) If the applicant is a community residential home, the
3261 applicant must provide proof that it has met the requirements
3262 specified in chapter 419.
3263 (4) The applicant must furnish proof that the facility has
3264 received a satisfactory firesafety inspection. The local
3265 authority having jurisdiction or the State Fire Marshal must
3266 conduct the inspection within 30 days after written request by
3267 the applicant.
3268 (5) The applicant must furnish documentation of a
3269 satisfactory sanitation inspection of the facility by the county
3270 health department.
3271 (6) In addition to the license categories available in s.
3272 408.808, a provisional license may be issued to an applicant
3273 making initial application for licensure or making application
3274 for a change of ownership. A provisional license shall be
3275 limited in duration to a specific period of time not to exceed 6
3276 months, as determined by the agency.
3277 (6)(7) A county or municipality may not issue an
3278 occupational license that is being obtained for the purpose of
3279 operating a facility regulated under this part without first
3280 ascertaining that the applicant has been licensed to operate
3281 such facility at the specified location or locations by the
3282 agency. The agency shall furnish to local agencies responsible
3283 for issuing occupational licenses sufficient instruction for
3284 making such determinations.
3285 Section 75. Section 429.71, Florida Statutes, is amended to
3286 read:
3287 429.71 Classification of violations deficiencies;
3288 administrative fines.—
3289 (1) In addition to the requirements of part II of chapter
3290 408 and in addition to any other liability or penalty provided
3291 by law, the agency may impose an administrative fine on a
3292 provider according to the following classification:
3293 (a) Class I violations are defined in s. 408.813 those
3294 conditions or practices related to the operation and maintenance
3295 of an adult family-care home or to the care of residents which
3296 the agency determines present an imminent danger to the
3297 residents or guests of the facility or a substantial probability
3298 that death or serious physical or emotional harm would result
3299 therefrom. The condition or practice that constitutes a class I
3300 violation must be abated or eliminated within 24 hours, unless a
3301 fixed period, as determined by the agency, is required for
3302 correction. A class I violation deficiency is subject to an
3303 administrative fine in an amount not less than $500 and not
3304 exceeding $1,000 for each violation. A fine may be levied
3305 notwithstanding the correction of the deficiency.
3306 (b) Class II violations are defined in s. 408.813 those
3307 conditions or practices related to the operation and maintenance
3308 of an adult family-care home or to the care of residents which
3309 the agency determines directly threaten the physical or
3310 emotional health, safety, or security of the residents, other
3311 than class I violations. A class II violation is subject to an
3312 administrative fine in an amount not less than $250 and not
3313 exceeding $500 for each violation. A citation for a class II
3314 violation must specify the time within which the violation is
3315 required to be corrected. If a class II violation is corrected
3316 within the time specified, no civil penalty shall be imposed,
3317 unless it is a repeated offense.
3318 (c) Class III violations are defined in s. 408.813 those
3319 conditions or practices related to the operation and maintenance
3320 of an adult family-care home or to the care of residents which
3321 the agency determines indirectly or potentially threaten the
3322 physical or emotional health, safety, or security of residents,
3323 other than class I or class II violations. A class III violation
3324 is subject to an administrative fine in an amount not less than
3325 $100 and not exceeding $250 for each violation. A citation for a
3326 class III violation shall specify the time within which the
3327 violation is required to be corrected. If a class III violation
3328 is corrected within the time specified, no civil penalty shall
3329 be imposed, unless it is a repeated violation offense.
3330 (d) Class IV violations are defined in s. 408.813 those
3331 conditions or occurrences related to the operation and
3332 maintenance of an adult family-care home, or related to the
3333 required reports, forms, or documents, which do not have the
3334 potential of negatively affecting the residents. A provider that
3335 does not correct A class IV violation within the time limit
3336 specified by the agency is subject to an administrative fine in
3337 an amount not less than $50 and not exceeding $100 for each
3338 violation. Any class IV violation that is corrected during the
3339 time the agency survey is conducted will be identified as an
3340 agency finding and not as a violation, unless it is a repeat
3341 violation.
3342 (2) The agency may impose an administrative fine for
3343 violations which do not qualify as class I, class II, class III,
3344 or class IV violations. The amount of the fine shall not exceed
3345 $250 for each violation or $2,000 in the aggregate. Unclassified
3346 violations may include:
3347 (a) Violating any term or condition of a license.
3348 (b) Violating any provision of this part, part II of
3349 chapter 408, or applicable rules.
3350 (c) Failure to follow the criteria and procedures provided
3351 under part I of chapter 394 relating to the transportation,
3352 voluntary admission, and involuntary examination of adult
3353 family-care home residents.
3354 (d) Exceeding licensed capacity.
3355 (e) Providing services beyond the scope of the license.
3356 (f) Violating a moratorium.
3357 (3) Each day during which a violation occurs constitutes a
3358 separate offense.
3359 (4) In determining whether a penalty is to be imposed, and
3360 in fixing the amount of any penalty to be imposed, the agency
3361 must consider:
3362 (a) The gravity of the violation.
3363 (b) Actions taken by the provider to correct a violation.
3364 (c) Any previous violation by the provider.
3365 (d) The financial benefit to the provider of committing or
3366 continuing the violation.
3367 (5) As an alternative to or in conjunction with an
3368 administrative action against a provider, the agency may request
3369 a plan of corrective action that demonstrates a good faith
3370 effort to remedy each violation by a specific date, subject to
3371 the approval of the agency.
3372 (5)(6) The department shall set forth, by rule, notice
3373 requirements and procedures for correction of deficiencies.
3374 Section 76. Section 429.195, Florida Statutes, is amended
3375 to read:
3376 429.195 Rebates prohibited; penalties.—
3377 (1) It is unlawful for any assisted living facility
3378 licensed under this part to contract or promise to pay or
3379 receive any commission, bonus, kickback, or rebate or engage in
3380 any split-fee arrangement in any form whatsoever with any
3381 person, health care provider, or health care facility as
3382 provided in s. 817.505 physician, surgeon, organization, agency,
3383 or person, either directly or indirectly, for residents referred
3384 to an assisted living facility licensed under this part. A
3385 facility may employ or contract with persons to market the
3386 facility, provided the employee or contract provider clearly
3387 indicates that he or she represents the facility. A person or
3388 agency independent of the facility may provide placement or
3389 referral services for a fee to individuals seeking assistance in
3390 finding a suitable facility; however, any fee paid for placement
3391 or referral services must be paid by the individual looking for
3392 a facility, not by the facility.
3393 (2) This section does not apply to:
3394 (a) An individual employed by the assisted living facility
3395 or with whom the facility contracts to market the facility, if
3396 the individual clearly indicates that he or she works with or
3397 for the facility.
3398 (b) Payments by an assisted living facility to a referral
3399 service that provides information, consultation, or referrals to
3400 consumers to assist them in finding appropriate care or housing
3401 options for seniors or disabled adults if such referred
3402 consumers are not Medicaid recipients.
3403 (c) A resident of an assisted living facility who refers a
3404 friend, family member, or other individuals with whom the
3405 resident has a personal relationship to the assisted living
3406 facility, in which case the assisted living facility may provide
3407 a monetary reward to the resident for making such referral.
3408 (3)(2) A violation of this section shall be considered
3409 patient brokering and is punishable as provided in s. 817.505.
3410 Section 77. Section 429.915, Florida Statutes, is amended
3411 to read:
3412 429.915 Conditional license.—In addition to the license
3413 categories available in part II of chapter 408, the agency may
3414 issue a conditional license to an applicant for license renewal
3415 or change of ownership if the applicant fails to meet all
3416 standards and requirements for licensure. A conditional license
3417 issued under this subsection must be limited to a specific
3418 period not exceeding 6 months, as determined by the agency, and
3419 must be accompanied by an approved plan of correction.
3420 Section 78. Subsection (3) of section 430.80, Florida
3421 Statutes, is amended to read:
3422 430.80 Implementation of a teaching nursing home pilot
3423 project.—
3424 (3) To be designated as a teaching nursing home, a nursing
3425 home licensee must, at a minimum:
3426 (a) Provide a comprehensive program of integrated senior
3427 services that include institutional services and community-based
3428 services;
3429 (b) Participate in a nationally recognized accreditation
3430 program and hold a valid accreditation, such as the
3431 accreditation awarded by the Joint Commission on Accreditation
3432 of Healthcare Organizations, or, at the time of initial
3433 designation, possess a Gold Seal Award as conferred by the state
3434 on its licensed nursing home;
3435 (c) Have been in business in this state for a minimum of 10
3436 consecutive years;
3437 (d) Demonstrate an active program in multidisciplinary
3438 education and research that relates to gerontology;
3439 (e) Have a formalized contractual relationship with at
3440 least one accredited health profession education program located
3441 in this state;
3442 (f) Have senior staff members who hold formal faculty
3443 appointments at universities, which must include at least one
3444 accredited health profession education program; and
3445 (g) Maintain insurance coverage pursuant to s.
3446 400.141(1)(q) 400.141(1)(s) or proof of financial responsibility
3447 in a minimum amount of $750,000. Such proof of financial
3448 responsibility may include:
3449 1. Maintaining an escrow account consisting of cash or
3450 assets eligible for deposit in accordance with s. 625.52; or
3451 2. Obtaining and maintaining pursuant to chapter 675 an
3452 unexpired, irrevocable, nontransferable and nonassignable letter
3453 of credit issued by any bank or savings association organized
3454 and existing under the laws of this state or any bank or savings
3455 association organized under the laws of the United States which
3456 that has its principal place of business in this state or has a
3457 branch office that which is authorized to receive deposits in
3458 this state. The letter of credit shall be used to satisfy the
3459 obligation of the facility to the claimant upon presentment of a
3460 final judgment indicating liability and awarding damages to be
3461 paid by the facility or upon presentment of a settlement
3462 agreement signed by all parties to the agreement if when such
3463 final judgment or settlement is a result of a liability claim
3464 against the facility.
3465 Section 79. Paragraph (h) of subsection (2) of section
3466 430.81, Florida Statutes, is amended to read:
3467 430.81 Implementation of a teaching agency for home and
3468 community-based care.—
3469 (2) The Department of Elderly Affairs may designate a home
3470 health agency as a teaching agency for home and community-based
3471 care if the home health agency:
3472 (h) Maintains insurance coverage pursuant to s.
3473 400.141(1)(q) 400.141(1)(s) or proof of financial responsibility
3474 in a minimum amount of $750,000. Such proof of financial
3475 responsibility may include:
3476 1. Maintaining an escrow account consisting of cash or
3477 assets eligible for deposit in accordance with s. 625.52; or
3478 2. Obtaining and maintaining, pursuant to chapter 675, an
3479 unexpired, irrevocable, nontransferable, and nonassignable
3480 letter of credit issued by any bank or savings association
3481 authorized to do business in this state. This letter of credit
3482 shall be used to satisfy the obligation of the agency to the
3483 claimant upon presentation of a final judgment indicating
3484 liability and awarding damages to be paid by the facility or
3485 upon presentment of a settlement agreement signed by all parties
3486 to the agreement if when such final judgment or settlement is a
3487 result of a liability claim against the agency.
3488 Section 80. Paragraph (d) of subsection (9) of section
3489 440.102, Florida Statutes, is amended to read:
3490 440.102 Drug-free workplace program requirements.—The
3491 following provisions apply to a drug-free workplace program
3492 implemented pursuant to law or to rules adopted by the Agency
3493 for Health Care Administration:
3494 (9) DRUG-TESTING STANDARDS FOR LABORATORIES.—
3495 (d) The laboratory shall submit to the Agency for Health
3496 Care Administration a monthly report with statistical
3497 information regarding the testing of employees and job
3498 applicants. The report must include information on the methods
3499 of analysis conducted, the drugs tested for, the number of
3500 positive and negative results for both initial tests and
3501 confirmation tests, and any other information deemed appropriate
3502 by the Agency for Health Care Administration. A monthly report
3503 must not identify specific employees or job applicants.
3504 Section 81. Paragraph (a) of subsection (2) of section
3505 440.13, Florida Statutes, is amended to read:
3506 440.13 Medical services and supplies; penalty for
3507 violations; limitations.—
3508 (2) MEDICAL TREATMENT; DUTY OF EMPLOYER TO FURNISH.—
3509 (a) Subject to the limitations specified elsewhere in this
3510 chapter, the employer shall furnish to the employee such
3511 medically necessary remedial treatment, care, and attendance for
3512 such period as the nature of the injury or the process of
3513 recovery may require, which is in accordance with established
3514 practice parameters and protocols of treatment as provided for
3515 in this chapter, including medicines, medical supplies, durable
3516 medical equipment, orthoses, prostheses, and other medically
3517 necessary apparatus. Remedial treatment, care, and attendance,
3518 including work-hardening programs or pain-management programs
3519 accredited by the Commission on Accreditation of Rehabilitation
3520 Facilities or the Joint Commission on the Accreditation of
3521 Health Organizations or pain-management programs affiliated with
3522 medical schools, shall be considered as covered treatment only
3523 when such care is given based on a referral by a physician as
3524 defined in this chapter. Medically necessary treatment, care,
3525 and attendance does not include chiropractic services in excess
3526 of 24 treatments or rendered 12 weeks beyond the date of the
3527 initial chiropractic treatment, whichever comes first, unless
3528 the carrier authorizes additional treatment or the employee is
3529 catastrophically injured.
3530
3531 Failure of the carrier to timely comply with this subsection
3532 shall be a violation of this chapter and the carrier shall be
3533 subject to penalties as provided for in s. 440.525.
3534 Section 82. Paragraph (a) of subsection (2) of section
3535 468.1695, Florida Statutes, is amended to read:
3536 468.1695 Licensure by examination.—
3537 (2) The department shall examine each applicant who the
3538 board certifies has completed the application form and remitted
3539 an examination fee set by the board not to exceed $250 and who:
3540 (a)1. Holds a baccalaureate degree from an accredited
3541 college or university and majored in health care administration,
3542 health services administration, or an equivalent major, or has
3543 credit for at least 60 semester hours in subjects, as prescribed
3544 by rule of the board, which prepare the applicant for total
3545 management of a nursing home; and
3546 2. Has fulfilled the requirements of a college-affiliated
3547 or university-affiliated internship in nursing home
3548 administration or of a 1,000-hour nursing home administrator-in
3549 training program prescribed by the board; or
3550 Section 83. Subsection (1) of section 483.035, Florida
3551 Statutes, is amended to read:
3552 483.035 Clinical laboratories operated by practitioners for
3553 exclusive use; licensure and regulation.—
3554 (1) A clinical laboratory operated by one or more
3555 practitioners licensed under chapter 458, chapter 459, chapter
3556 460, chapter 461, chapter 462, or chapter 466, or as an advanced
3557 registered nurse practitioner licensed under part I in chapter
3558 464, exclusively in connection with the diagnosis and treatment
3559 of their own patients, must be licensed under this part and must
3560 comply with the provisions of this part, except that the agency
3561 shall adopt rules for staffing, for personnel, including
3562 education and training of personnel, for proficiency testing,
3563 and for construction standards relating to the licensure and
3564 operation of the laboratory based upon and not exceeding the
3565 same standards contained in the federal Clinical Laboratory
3566 Improvement Amendments of 1988 and the federal regulations
3567 adopted thereunder.
3568 Section 84. Subsections (1) and (9) of section 483.051,
3569 Florida Statutes, are amended to read:
3570 483.051 Powers and duties of the agency.—The agency shall
3571 adopt rules to implement this part, which rules must include,
3572 but are not limited to, the following:
3573 (1) LICENSING; QUALIFICATIONS.—The agency shall provide for
3574 biennial licensure of all nonwaived clinical laboratories
3575 meeting the requirements of this part and shall prescribe the
3576 qualifications necessary for such licensure, including, but not
3577 limited to, application for or proof of a federal Clinical
3578 Laboratory Improvement Amendment (CLIA) certificate. For
3579 purposes of this section, the term “nonwaived clinical
3580 laboratories” means laboratories that perform any test that the
3581 Centers for Medicare and Medicaid Services has determined does
3582 not qualify for a certificate of waiver under the Clinical
3583 Laboratory Improvement Amendments of 1988 and the federal rules
3584 adopted thereunder.
3585 (9) ALTERNATE-SITE TESTING.—The agency, in consultation
3586 with the Board of Clinical Laboratory Personnel, shall adopt, by
3587 rule, the criteria for alternate-site testing to be performed
3588 under the supervision of a clinical laboratory director. The
3589 elements to be addressed in the rule include, but are not
3590 limited to: a hospital internal needs assessment; a protocol of
3591 implementation including tests to be performed and who will
3592 perform the tests; criteria to be used in selecting the method
3593 of testing to be used for alternate-site testing; minimum
3594 training and education requirements for those who will perform
3595 alternate-site testing, such as documented training, licensure,
3596 certification, or other medical professional background not
3597 limited to laboratory professionals; documented inservice
3598 training as well as initial and ongoing competency validation;
3599 an appropriate internal and external quality control protocol;
3600 an internal mechanism for identifying and tracking alternate
3601 site testing by the central laboratory; and recordkeeping
3602 requirements. Alternate-site testing locations must register
3603 when the clinical laboratory applies to renew its license. For
3604 purposes of this subsection, the term “alternate-site testing”
3605 means any laboratory testing done under the administrative
3606 control of a hospital, but performed out of the physical or
3607 administrative confines of the central laboratory.
3608 Section 85. Subsection (1) of section 483.23, Florida
3609 Statutes, is amended to read:
3610 483.23 Offenses; criminal penalties.—
3611 (1)(a) It is unlawful for any person to:
3612 1. Operate, maintain, direct, or engage in the business of
3613 operating a clinical laboratory unless she or he has obtained a
3614 clinical laboratory license from the agency or is exempt under
3615 s. 483.031.
3616 2. Conduct, maintain, or operate a clinical laboratory,
3617 other than an exempt laboratory or a laboratory operated under
3618 s. 483.035, unless the clinical laboratory is under the direct
3619 and responsible supervision and direction of a person licensed
3620 under part III of this chapter.
3621 3. Allow any person other than an individual licensed under
3622 part III of this chapter to perform clinical laboratory
3623 procedures, except in the operation of a laboratory exempt under
3624 s. 483.031 or a laboratory operated under s. 483.035.
3625 4. Violate or aid and abet in the violation of any
3626 provision of this part or the rules adopted under this part.
3627 (b) The performance of any act specified in paragraph (a)
3628 shall be referred by the agency to the local law enforcement
3629 agency and constitutes a misdemeanor of the second degree,
3630 punishable as provided in s. 775.082 or s. 775.083.
3631 Additionally, the agency may issue and deliver a notice to cease
3632 and desist from such act and may impose by citation an
3633 administrative penalty not to exceed $5,000 per act. Each day
3634 that unlicensed activity continues after issuance of a notice to
3635 cease and desist constitutes a separate act.
3636 Section 86. Subsection (1) of section 483.245, Florida
3637 Statutes, is amended, and subsection (3) is added to that
3638 section, to read:
3639 483.245 Rebates prohibited; penalties.—
3640 (1) It is unlawful for any person to pay or receive any
3641 commission, bonus, kickback, or rebate or engage in any split
3642 fee arrangement in any form whatsoever with any dialysis
3643 facility, physician, surgeon, organization, agency, or person,
3644 either directly or indirectly, for patients referred to a
3645 clinical laboratory licensed under this part. A clinical
3646 laboratory is prohibited from providing, directly or indirectly,
3647 through employees, contractors, an independent staffing company,
3648 lease agreement, or otherwise, personnel to perform any
3649 functions or duties in a physician’s office, or any part of a
3650 physician’s office, for any purpose whatsoever, including for
3651 the collection of handling of specimens, unless the laboratory
3652 and the physician’s office are wholly owned and operated by the
3653 same entity. A clinical laboratory is prohibited from leasing
3654 space within any part of a physician’s office for any purpose,
3655 including for the purpose of establishing a collection station.
3656 (3) The agency shall promptly investigate all complaints of
3657 noncompliance with subsection (1). The agency shall impose a
3658 fine of $5,000 for each separate violation of subsection (1). In
3659 addition, the agency shall deny an application for a license or
3660 license renewal if the applicant, or any other entity with one
3661 or more common controlling interests in the applicant,
3662 demonstrates a pattern of violating subsection (1). A pattern
3663 may be demonstrated by a showing of at least two such
3664 violations.
3665 Section 87. Section 483.294, Florida Statutes, is amended
3666 to read:
3667 483.294 Inspection of centers.—In accordance with s.
3668 408.811, the agency shall biennially, at least once annually,
3669 inspect the premises and operations of all centers subject to
3670 licensure under this part.
3671 Section 88. Paragraph (a) of subsection (54) of section
3672 499.003, Florida Statutes, is amended to read:
3673 499.003 Definitions of terms used in this part.—As used in
3674 this part, the term:
3675 (54) “Wholesale distribution” means distribution of
3676 prescription drugs to persons other than a consumer or patient,
3677 but does not include:
3678 (a) Any of the following activities, which is not a
3679 violation of s. 499.005(21) if such activity is conducted in
3680 accordance with s. 499.01(2)(g):
3681 1. The purchase or other acquisition by a hospital or other
3682 health care entity that is a member of a group purchasing
3683 organization of a prescription drug for its own use from the
3684 group purchasing organization or from other hospitals or health
3685 care entities that are members of that organization.
3686 2. The sale, purchase, or trade of a prescription drug or
3687 an offer to sell, purchase, or trade a prescription drug by a
3688 charitable organization described in s. 501(c)(3) of the
3689 Internal Revenue Code of 1986, as amended and revised, to a
3690 nonprofit affiliate of the organization to the extent otherwise
3691 permitted by law.
3692 3. The sale, purchase, or trade of a prescription drug or
3693 an offer to sell, purchase, or trade a prescription drug among
3694 hospitals or other health care entities that are under common
3695 control. For purposes of this subparagraph, “common control”
3696 means the power to direct or cause the direction of the
3697 management and policies of a person or an organization, whether
3698 by ownership of stock, by voting rights, by contract, or
3699 otherwise.
3700 4. The sale, purchase, trade, or other transfer of a
3701 prescription drug from or for any federal, state, or local
3702 government agency or any entity eligible to purchase
3703 prescription drugs at public health services prices pursuant to
3704 Pub. L. No. 102-585, s. 602 to a contract provider or its
3705 subcontractor for eligible patients of the agency or entity
3706 under the following conditions:
3707 a. The agency or entity must obtain written authorization
3708 for the sale, purchase, trade, or other transfer of a
3709 prescription drug under this subparagraph from the State Surgeon
3710 General or his or her designee.
3711 b. The contract provider or subcontractor must be
3712 authorized by law to administer or dispense prescription drugs.
3713 c. In the case of a subcontractor, the agency or entity
3714 must be a party to and execute the subcontract.
3715 d. A contract provider or subcontractor must maintain
3716 separate and apart from other prescription drug inventory any
3717 prescription drugs of the agency or entity in its possession.
3718 d.e. The contract provider and subcontractor must maintain
3719 and produce immediately for inspection all records of movement
3720 or transfer of all the prescription drugs belonging to the
3721 agency or entity, including, but not limited to, the records of
3722 receipt and disposition of prescription drugs. Each contractor
3723 and subcontractor dispensing or administering these drugs must
3724 maintain and produce records documenting the dispensing or
3725 administration. Records that are required to be maintained
3726 include, but are not limited to, a perpetual inventory itemizing
3727 drugs received and drugs dispensed by prescription number or
3728 administered by patient identifier, which must be submitted to
3729 the agency or entity quarterly.
3730 e.f. The contract provider or subcontractor may administer
3731 or dispense the prescription drugs only to the eligible patients
3732 of the agency or entity or must return the prescription drugs
3733 for or to the agency or entity. The contract provider or
3734 subcontractor must require proof from each person seeking to
3735 fill a prescription or obtain treatment that the person is an
3736 eligible patient of the agency or entity and must, at a minimum,
3737 maintain a copy of this proof as part of the records of the
3738 contractor or subcontractor required under sub-subparagraph e.
3739 f.g. In addition to the departmental inspection authority
3740 set forth in s. 499.051, the establishment of the contract
3741 provider and subcontractor and all records pertaining to
3742 prescription drugs subject to this subparagraph shall be subject
3743 to inspection by the agency or entity. All records relating to
3744 prescription drugs of a manufacturer under this subparagraph
3745 shall be subject to audit by the manufacturer of those drugs,
3746 without identifying individual patient information.
3747 Section 89. Subsection (1) of section 627.645, Florida
3748 Statutes, is amended to read:
3749 627.645 Denial of health insurance claims restricted.—
3750 (1) No claim for payment under a health insurance policy or
3751 self-insured program of health benefits for treatment, care, or
3752 services in a licensed hospital which is accredited by the Joint
3753 Commission on the Accreditation of Hospitals, the American
3754 Osteopathic Association, or the Commission on the Accreditation
3755 of Rehabilitative Facilities shall be denied because such
3756 hospital lacks major surgical facilities and is primarily of a
3757 rehabilitative nature, if such rehabilitation is specifically
3758 for treatment of physical disability.
3759 Section 90. Paragraph (c) of subsection (2) of section
3760 627.668, Florida Statutes, is amended to read:
3761 627.668 Optional coverage for mental and nervous disorders
3762 required; exception.—
3763 (2) Under group policies or contracts, inpatient hospital
3764 benefits, partial hospitalization benefits, and outpatient
3765 benefits consisting of durational limits, dollar amounts,
3766 deductibles, and coinsurance factors shall not be less favorable
3767 than for physical illness generally, except that:
3768 (c) Partial hospitalization benefits shall be provided
3769 under the direction of a licensed physician. For purposes of
3770 this part, the term “partial hospitalization services” is
3771 defined as those services offered by a program accredited by the
3772 Joint Commission on Accreditation of Hospitals (JCAH) or in
3773 compliance with equivalent standards. Alcohol rehabilitation
3774 programs accredited by the Joint Commission on Accreditation of
3775 Hospitals or approved by the state and licensed drug abuse
3776 rehabilitation programs shall also be qualified providers under
3777 this section. In any benefit year, if partial hospitalization
3778 services or a combination of inpatient and partial
3779 hospitalization are utilized, the total benefits paid for all
3780 such services shall not exceed the cost of 30 days of inpatient
3781 hospitalization for psychiatric services, including physician
3782 fees, which prevail in the community in which the partial
3783 hospitalization services are rendered. If partial
3784 hospitalization services benefits are provided beyond the limits
3785 set forth in this paragraph, the durational limits, dollar
3786 amounts, and coinsurance factors thereof need not be the same as
3787 those applicable to physical illness generally.
3788 Section 91. Subsection (3) of section 627.669, Florida
3789 Statutes, is amended to read:
3790 627.669 Optional coverage required for substance abuse
3791 impaired persons; exception.—
3792 (3) The benefits provided under this section shall be
3793 applicable only if treatment is provided by, or under the
3794 supervision of, or is prescribed by, a licensed physician or
3795 licensed psychologist and if services are provided in a program
3796 accredited by the Joint Commission on Accreditation of Hospitals
3797 or approved by the state.
3798 Section 92. Paragraph (a) of subsection (1) of section
3799 627.736, Florida Statutes, is amended to read:
3800 627.736 Required personal injury protection benefits;
3801 exclusions; priority; claims.—
3802 (1) REQUIRED BENEFITS.—Every insurance policy complying
3803 with the security requirements of s. 627.733 shall provide
3804 personal injury protection to the named insured, relatives
3805 residing in the same household, persons operating the insured
3806 motor vehicle, passengers in such motor vehicle, and other
3807 persons struck by such motor vehicle and suffering bodily injury
3808 while not an occupant of a self-propelled vehicle, subject to
3809 the provisions of subsection (2) and paragraph (4)(e), to a
3810 limit of $10,000 for loss sustained by any such person as a
3811 result of bodily injury, sickness, disease, or death arising out
3812 of the ownership, maintenance, or use of a motor vehicle as
3813 follows:
3814 (a) Medical benefits.—Eighty percent of all reasonable
3815 expenses for medically necessary medical, surgical, X-ray,
3816 dental, and rehabilitative services, including prosthetic
3817 devices, and medically necessary ambulance, hospital, and
3818 nursing services. However, the medical benefits shall provide
3819 reimbursement only for such services and care that are lawfully
3820 provided, supervised, ordered, or prescribed by a physician
3821 licensed under chapter 458 or chapter 459, a dentist licensed
3822 under chapter 466, or a chiropractic physician licensed under
3823 chapter 460 or that are provided by any of the following persons
3824 or entities:
3825 1. A hospital or ambulatory surgical center licensed under
3826 chapter 395.
3827 2. A person or entity licensed under ss. 401.2101-401.45
3828 that provides emergency transportation and treatment.
3829 3. An entity wholly owned by one or more physicians
3830 licensed under chapter 458 or chapter 459, chiropractic
3831 physicians licensed under chapter 460, or dentists licensed
3832 under chapter 466 or by such practitioner or practitioners and
3833 the spouse, parent, child, or sibling of that practitioner or
3834 those practitioners.
3835 4. An entity wholly owned, directly or indirectly, by a
3836 hospital or hospitals.
3837 5. A health care clinic licensed under ss. 400.990-400.995
3838 that is:
3839 a. Accredited by the Joint Commission on Accreditation of
3840 Healthcare Organizations, the American Osteopathic Association,
3841 the Commission on Accreditation of Rehabilitation Facilities, or
3842 the Accreditation Association for Ambulatory Health Care, Inc.;
3843 or
3844 b. A health care clinic that:
3845 (I) Has a medical director licensed under chapter 458,
3846 chapter 459, or chapter 460;
3847 (II) Has been continuously licensed for more than 3 years
3848 or is a publicly traded corporation that issues securities
3849 traded on an exchange registered with the United States
3850 Securities and Exchange Commission as a national securities
3851 exchange; and
3852 (III) Provides at least four of the following medical
3853 specialties:
3854 (A) General medicine.
3855 (B) Radiography.
3856 (C) Orthopedic medicine.
3857 (D) Physical medicine.
3858 (E) Physical therapy.
3859 (F) Physical rehabilitation.
3860 (G) Prescribing or dispensing outpatient prescription
3861 medication.
3862 (H) Laboratory services.
3863
3864 The Financial Services Commission shall adopt by rule the form
3865 that must be used by an insurer and a health care provider
3866 specified in subparagraph 3., subparagraph 4., or subparagraph
3867 5. to document that the health care provider meets the criteria
3868 of this paragraph, which rule must include a requirement for a
3869 sworn statement or affidavit.
3870
3871 Only insurers writing motor vehicle liability insurance in this
3872 state may provide the required benefits of this section, and no
3873 such insurer shall require the purchase of any other motor
3874 vehicle coverage other than the purchase of property damage
3875 liability coverage as required by s. 627.7275 as a condition for
3876 providing such required benefits. Insurers may not require that
3877 property damage liability insurance in an amount greater than
3878 $10,000 be purchased in conjunction with personal injury
3879 protection. Such insurers shall make benefits and required
3880 property damage liability insurance coverage available through
3881 normal marketing channels. Any insurer writing motor vehicle
3882 liability insurance in this state who fails to comply with such
3883 availability requirement as a general business practice shall be
3884 deemed to have violated part IX of chapter 626, and such
3885 violation shall constitute an unfair method of competition or an
3886 unfair or deceptive act or practice involving the business of
3887 insurance; and any such insurer committing such violation shall
3888 be subject to the penalties afforded in such part, as well as
3889 those which may be afforded elsewhere in the insurance code.
3890 Section 93. Subsection (12) of section 641.495, Florida
3891 Statutes, is amended to read:
3892 641.495 Requirements for issuance and maintenance of
3893 certificate.—
3894 (12) The provisions of part I of chapter 395 do not apply
3895 to a health maintenance organization that, on or before January
3896 1, 1991, provides not more than 10 outpatient holding beds for
3897 short-term and hospice-type patients in an ambulatory care
3898 facility for its members, provided that such health maintenance
3899 organization maintains current accreditation by the Joint
3900 Commission on Accreditation of Health Care Organizations, the
3901 Accreditation Association for Ambulatory Health Care, or the
3902 National Committee for Quality Assurance.
3903 Section 94. Subsection (13) of section 651.118, Florida
3904 Statutes, is amended to read:
3905 651.118 Agency for Health Care Administration; certificates
3906 of need; sheltered beds; community beds.—
3907 (13) Residents, as defined in this chapter, are not
3908 considered new admissions for the purpose of s. 400.141(1)(n)
3909 400.141(1)(o)1.d.
3910 Section 95. Subsection (2) of section 766.1015, Florida
3911 Statutes, is amended to read:
3912 766.1015 Civil immunity for members of or consultants to
3913 certain boards, committees, or other entities.—
3914 (2) Such committee, board, group, commission, or other
3915 entity must be established in accordance with state law or in
3916 accordance with requirements of the Joint Commission on
3917 Accreditation of Healthcare Organizations, established and duly
3918 constituted by one or more public or licensed private hospitals
3919 or behavioral health agencies, or established by a governmental
3920 agency. To be protected by this section, the act, decision,
3921 omission, or utterance may not be made or done in bad faith or
3922 with malicious intent.
3923 Section 96. Paragraph (j) is added to subsection (3) of
3924 section 817.505, Florida Statutes, to read:
3925 817.505 Patient brokering prohibited; exceptions;
3926 penalties.—
3927 (3) This section shall not apply to:
3928 (j) Payments by an assisted living facility, as defined in
3929 s. 429.02, or an agreement for or solicitation, offer, or
3930 receipt of such payment by a referral service permitted under s.
3931 429.195(2).
3932 Section 97. Except as otherwise expressly provided in this
3933 act, this act shall take effect July 1, 2012.
3934
3935 ================= T I T L E A M E N D M E N T ================
3936 And the title is amended as follows:
3937 Delete everything before the enacting clause
3938 and insert:
3939 A bill to be entitled
3940 An act relating to health care facilities; amending s.
3941 83.42, F.S., relating to exclusions from part II of
3942 ch. 83, F.S., the Florida Residential Landlord and
3943 Tenant Act; clarifying that the procedures in s.
3944 400.0255, F.S., for transfers and discharges are
3945 exclusive to residents of a nursing home licensed
3946 under part II of ch. 400, F.S.; amending s. 112.0455,
3947 F.S., relating to the Drug-Free Workplace Act;
3948 deleting a provision regarding retroactivity of the
3949 act; deleting a provision that the act does not
3950 abrogate the right of an employer under state law to
3951 conduct drug tests before a specified date; deleting a
3952 provision that requires a laboratory to submit to the
3953 Agency for Health Care Administration a monthly report
3954 containing statistical information regarding the
3955 testing of employees and job applicants; amending s.
3956 318.21, F.S.; providing that a portion of the
3957 additional fines assessed for traffic violations
3958 within an enhanced penalty zone be remitted to the
3959 Department of Revenue and deposited into the Brain and
3960 Spinal Cord Injury Trust Fund of the Department of
3961 Health to serve certain Medicaid recipients; amending
3962 s. 383.011, F.S.; requiring the Department of Health
3963 to establish an interagency agreement with the
3964 Department of Children and Family Services for
3965 management of the Special Supplemental Nutrition
3966 Program for Women, Infants, and Children; specifying
3967 responsibilities of each department; repealing s.
3968 383.325, F.S., relating to confidentiality of
3969 inspection reports of a licensed birth center
3970 facilities; creating s. 385.2031, F.S.; designating
3971 the Florida Hospital/Sandford-Burnham Translational
3972 Research Institute for Metabolism and Diabetes as a
3973 resource for research in the prevention and treatment
3974 of diabetes; amending s. 394.4787, F.S.; conforming a
3975 cross-reference; amending s. 395.002, F.S.; revising
3976 and deleting definitions applicable to the regulation
3977 of hospitals and other licensed facilities; conforming
3978 a cross-reference; amending s. 395.003, F.S.; deleting
3979 an obsolete provision; conforming a cross-reference;
3980 amending s. 395.0161, F.S.; deleting a requirement
3981 that facilities licensed under part I of ch. 395,
3982 F.S., pay licensing fees at the time of inspection;
3983 amending s. 395.0193, F.S.; requiring a licensed
3984 facility to report certain peer review information and
3985 final disciplinary actions to the Division of Medical
3986 Quality Assurance of the Department of Health rather
3987 than the Division of Health Quality Assurance of the
3988 Agency for Health Care Administration; amending s.
3989 395.1023, F.S.; providing for the Department of
3990 Children and Family Services rather than the
3991 Department of Health to perform certain functions with
3992 respect to child protection cases; requiring certain
3993 hospitals to notify the Department of Children and
3994 Family Services of compliance; amending s. 395.1041,
3995 F.S., relating to hospital emergency services and
3996 care; deleting obsolete provisions; repealing s.
3997 395.1046, F.S., relating to procedures employed by the
3998 Agency for Health Care Administration when
3999 investigating complaints against hospitals; amending
4000 s. 395.1055, F.S.; requiring additional housekeeping
4001 and sanitation procedures in licensed facilities for
4002 infection control purposes; authorizing the Agency for
4003 Health Care Administration to impose a fine for
4004 failure to comply with housekeeping and sanitation
4005 procedures requirements; requiring that licensed
4006 facility beds conform to standards specified by the
4007 Agency for Health Care Administration, the Florida
4008 Building Code, and the Florida Fire Prevention Code;
4009 amending s. 395.3025, F.S.; authorizing the disclosure
4010 of patient records to the Department of Health rather
4011 than the Agency for Health Care Administration in
4012 accordance with an issued subpoena; requiring the
4013 department, rather than the agency, to make available,
4014 upon written request by a practitioner against whom
4015 probable cause has been found, any patient records
4016 that form the basis of the determination of probable
4017 cause; amending s. 395.3036, F.S.; correcting a cross
4018 reference; repealing s. 395.3037, F.S., relating to
4019 redundant definitions for the Department of Health and
4020 the Agency for Health Care Administration; amending s.
4021 395.401, F.S.; deleting local need assessment for the
4022 establishment of trauma centers; amending s. 395.402,
4023 F.S.; deleting department rulemaking authority for
4024 determination of the number and location of trauma
4025 centers in the state; amending s. 395.4025, F.S.;
4026 deleting department authority with respect to the
4027 selection of hospitals designated as trauma centers;
4028 deleting timelines for the submission of applications
4029 from hospitals seeking to be designated as trauma
4030 centers; amending ss. 154.11, 394.741, 395.3038,
4031 400.925, 400.9935, 408.05, 440.13, 627.645, 627.668,
4032 627.669, 627.736, 641.495, and 766.1015, F.S.;
4033 revising references to the Joint Commission on
4034 Accreditation of Healthcare Organizations, the
4035 Commission on Accreditation of Rehabilitation
4036 Facilities, and the Council on Accreditation to
4037 conform to their current designations; amending s.
4038 395.602, F.S.; revising the definition of the term
4039 “rural hospital” to delete an obsolete provision;
4040 amending s. 400.021, F.S.; revising the definitions of
4041 the terms “geriatric outpatient clinic” and “resident
4042 care plan”; amending s. 400.0239, F.S.; conforming a
4043 provision to changes made by the act; amending s.
4044 400.0255, F.S.; revising provisions relating to
4045 hearings on resident transfer or discharge; amending
4046 s. 400.063, F.S.; deleting an obsolete cross
4047 reference; amending s. 400.071, F.S.; deleting
4048 provisions requiring a license applicant to submit a
4049 signed affidavit relating to financial or ownership
4050 interests, the number of beds, copies of civil
4051 verdicts or judgments involving the applicant, and a
4052 plan for quality assurance and risk management;
4053 amending s. 400.0712, F.S.; revising provisions
4054 relating to the issuance of inactive licenses;
4055 amending s. 400.111, F.S.; providing that a licensee
4056 must provide certain information relating to financial
4057 or ownership interests if requested by the Agency for
4058 Health Care Administration; amending s. 400.1183,
4059 F.S.; revising requirements relating to nursing home
4060 facility grievance reports; amending s. 400.141, F.S.;
4061 revising provisions relating to the provision of
4062 respite care in a facility; deleting requirements for
4063 the submission of certain reports to the agency
4064 relating to ownership interests, staffing ratios, and
4065 bankruptcy; deleting an obsolete provision; amending
4066 s. 400.142, F.S.; deleting the agency’s authority to
4067 adopt rules relating to orders not to resuscitate;
4068 amending s. 400.147, F.S.; revising provisions
4069 relating to adverse incident reports; deleting certain
4070 reporting requirements; repealing s. 400.148, F.S.,
4071 relating to the Medicaid “Up-or-Out” Quality of Care
4072 Contract Management Program; amending s. 400.19, F.S.;
4073 revising provisions relating to agency inspections of
4074 nursing home facilities; amending s. 400.191, F.S.;
4075 authorizing the facility to charge a fee for copies of
4076 resident records; amending s. 400.23, F.S.; specifying
4077 the content of rules relating to nursing home facility
4078 staffing requirements for residents under 21 years of
4079 age; amending s. 400.275, F.S.; revising agency duties
4080 with regard to training nursing home surveyor teams;
4081 revising requirements for team members; amending s.
4082 400.462, F.S.; revising the definition of
4083 “remuneration” to exclude items having a value of $15
4084 or less; amending s. 400.484, F.S.; revising the
4085 classification of violations by a home health agency
4086 for which the agency imposes an administrative fine;
4087 amending s. 400.506, F.S.; deleting language relating
4088 to exemptions from penalties imposed on nurse
4089 registries if a nurse registry does not bill the
4090 Florida Medicaid Program; authorizing an administrator
4091 to manage up to five nurse registries under certain
4092 circumstances; requiring an administrator to
4093 designate, in writing, for each licensed entity, a
4094 qualified alternate administrator to serve during the
4095 administrator’s absence; amending s. 400.509, F.S.;
4096 providing that organizations that provide companion or
4097 homemaker services only to persons with developmental
4098 disabilities, under contract with the Agency for
4099 Persons with Disabilities, are exempt from
4100 registration with the Agency for Health Care
4101 Administration; reenacting ss. 400.464(5)(b) and
4102 400.506(6)(a), F.S., relating to home health agencies
4103 and licensure of nurse registries, respectively, to
4104 incorporate the amendment made to s. 400.509, F.S., in
4105 references thereto; amending s. 400.601, F.S.;
4106 revising the definition of the term “hospice” to
4107 include limited liability companies; amending s.
4108 400.606, F.S.; revising the content requirements of
4109 the plan accompanying an initial or change-of
4110 ownership application for licensure of a hospice;
4111 revising requirements relating to certificates of need
4112 for certain hospice facilities; amending s. 400.915,
4113 F.S.; correcting an obsolete cross-reference to
4114 administrative rules; amending s. 400.931, F.S.;
4115 requiring each applicant for initial licensure, change
4116 of ownership, or license renewal to operate a licensed
4117 home medical equipment provider at a location outside
4118 the state to submit documentation of accreditation, or
4119 an application for accreditation, from an accrediting
4120 organization that is recognized by the Agency for
4121 Health Care Administration; requiring an applicant
4122 that has applied for accreditation to provide proof of
4123 accreditation within a specified time; deleting a
4124 requirement that an applicant for a home medical
4125 equipment provider license submit a surety bond to the
4126 agency; amending s. 400.967, F.S.; revising the
4127 classification of violations by intermediate care
4128 facilities for the developmentally disabled; providing
4129 a penalty for certain violations; amending s.
4130 400.9905, F.S.; revising the definitions of the terms
4131 “clinic” and “portable equipment provider”; revising
4132 requirements for an application for exemption from
4133 health care clinic licensure requirements for certain
4134 entities; providing for the agency to deny or revoke
4135 the exemption under certain circumstances; including
4136 health services provided to multiple locations within
4137 the definition of the term “portable health service or
4138 equipment provider”; amending s. 400.991, F.S.;
4139 conforming terminology; revising application
4140 requirements relating to documentation of financial
4141 ability to operate a mobile clinic; amending s.
4142 408.033, F.S.; providing that fees assessed on
4143 selected health care facilities and organizations may
4144 be collected prospectively at the time of licensure
4145 renewal and prorated for the licensing period;
4146 amending s. 408.034, F.S.; revising agency authority
4147 relating to licensing of intermediate care facilities
4148 for the developmentally disabled; amending s. 408.036,
4149 F.S.; deleting an exemption from certain certificate
4150 of-need review requirements for a hospice or a hospice
4151 inpatient facility; amending s. 408.037, F.S.;
4152 revising requirements for the financial information to
4153 be included in an application for a certificate of
4154 need; amending s. 408.043, F.S.; revising requirements
4155 for certain freestanding inpatient hospice care
4156 facilities to obtain a certificate of need; amending
4157 s. 408.061, F.S.; revising data reporting requirements
4158 for health care facilities; amending s. 408.07, F.S.;
4159 deleting a cross-reference; amending s. 408.10, F.S.;
4160 removing agency authority to investigate certain
4161 consumer complaints; amending s. 408.802, F.S.;
4162 removing applicability of part II of ch. 408, F.S.,
4163 relating to general licensure requirements, to private
4164 review agents; amending s. 408.804, F.S.; providing
4165 penalties for altering, defacing, or falsifying a
4166 license certificate issued by the agency or displaying
4167 such an altered, defaced, or falsified certificate;
4168 amending s. 408.806, F.S.; revising agency
4169 responsibilities for notification of licensees of
4170 impending expiration of a license; requiring payment
4171 of a late fee for a license application to be
4172 considered complete under certain circumstances;
4173 amending s. 408.8065, F.S.; revising the requirements
4174 for becoming licensed as a home health agency, home
4175 medical equipment provider, or health care clinic;
4176 amending s. 408.809, F.S.; revising provisions to
4177 include a schedule for background rescreenings of
4178 certain employees; amending s. 408.810, F.S.;
4179 requiring that the controlling interest of a health
4180 care licensee notify the agency of certain court
4181 proceedings; providing a penalty; amending s. 408.813,
4182 F.S.; authorizing the agency to impose fines for
4183 unclassified violations of part II of ch. 408, F.S.;
4184 amending s. 409.912, F.S.; revising provisions
4185 requiring the agency to post certain information
4186 relating to drugs subject to prior authorization on
4187 its Internet website; providing a definition of the
4188 term “step-edit”; amending s. 409.9122, F.S.;
4189 clarifying that until the time of recipient enrollment
4190 all hospitals shall be deemed to be a part of a
4191 managed care plan’s network in its application for
4192 participation; amending s. 429.11, F.S.; revising
4193 licensure application requirements for assisted living
4194 facilities to eliminate provisional licenses; amending
4195 s. 429.71, F.S.; revising the classification of
4196 violations by adult family-care homes; amending s.
4197 429.195, F.S.; providing exceptions to applicability
4198 of assisted living facility rebate restrictions;
4199 amending s. 429.915, F.S.; revising agency
4200 responsibilities regarding the issuance of conditional
4201 licenses; amending ss. 430.80, 430.81, and 651.118,
4202 F.S.; conforming cross-references; amending s.
4203 440.102, F.S.; removing a requirement that a
4204 laboratory submit to the Agency for Health Care
4205 Administration a monthly report containing statistical
4206 information regarding the testing of employees and job
4207 applicants to the Agency for Health Care
4208 Administration; amending s. 468.1695, F.S.; providing
4209 that a health services administration or an equivalent
4210 major shall satisfy the education requirements for
4211 nursing home administrator applicants; amending s.
4212 483.035, F.S.; providing for a clinical laboratory to
4213 be operated by certain nurses; amending s. 483.051,
4214 F.S.; requiring the Agency for Health Care
4215 Administration to provide for biennial licensure of
4216 all nonwaived laboratories that meet certain
4217 requirements; requiring the agency to prescribe
4218 qualifications for such licensure; defining nonwaived
4219 laboratories as laboratories that do not have a
4220 certificate of waiver from the Centers for Medicare
4221 and Medicaid Services; deleting requirements for the
4222 registration of an alternate site testing location
4223 when the clinical laboratory applies to renew its
4224 license; amending s. 483.23, F.S.; providing that
4225 certain violations relating to the operation of a
4226 clinical laboratory be referred by the Agency for
4227 Health Care Administration to the local law
4228 enforcement agency; authorizes the Agency for Health
4229 Care Administration to provide a cease and desist
4230 notice and impose administrative penalties and fines;
4231 amending s. 483.245, F.S.; prohibiting a clinical
4232 laboratory from placing a specimen collector or other
4233 personnel in any physician’s office, unless the
4234 clinical lab and the physician’s office are owned and
4235 operated by the same entity; providing for damages and
4236 injunctive relief; amending s. 483.294, F.S.; revising
4237 the frequency of agency inspections of multiphasic
4238 health testing centers; amending s. 499.003, F.S.;
4239 removing the requirement for certain prescription drug
4240 purchasers to maintain a separate inventory of certain
4241 prescription drugs; amending s. 817.505, F.S.;
4242 providing an exception to provisions prohibiting
4243 patient brokering; providing effective dates.