Florida Senate - 2012 CS for CS for SB 1884
By the Committees on Budget Subcommittee on Health and Human
Services Appropriations; and Health Regulation; and Senator
Garcia
603-04245B-12 20121884c2
1 A bill to be entitled
2 An act relating to health regulation by the Agency for
3 Health Care Administration; amending s. 83.42, F.S.,
4 relating to exclusions from part II of ch. 83, F.S.,
5 the Florida Residential Landlord and Tenant Act;
6 clarifying that the procedures in s. 400.0255, F.S.,
7 for transfers and discharges are exclusive to
8 residents of a nursing home licensed under part II of
9 ch. 400, F.S.; amending s. 112.0455, F.S., relating to
10 the Drug-Free Workplace Act; deleting a provision
11 regarding retroactivity of the act; deleting a
12 provision specifying that the act does not abrogate
13 the right of an employer under state law to conduct
14 drug tests before a certain date; deleting a provision
15 that requires a laboratory to submit to the Agency for
16 Health Care Administration a monthly report containing
17 statistical information regarding the testing of
18 employees and job applicants; amending s. 318.21,
19 F.S.; providing that a portion of the additional fines
20 assessed for traffic violations within an enhanced
21 penalty zone be remitted to the Department of Revenue
22 and deposited into the Brain and Spinal Cord Injury
23 Trust Fund of the Department of Health to serve
24 certain Medicaid recipients; repealing s. 383.325,
25 F.S., relating to confidentiality of inspection
26 reports of licensed birth center facilities; creating
27 s. 385.2031, F.S.; designating the Florida
28 Hospital/Sandford-Burnham Translational Research
29 Institute for Metabolism and Diabetes as a resource
30 for research in the prevention and treatment of
31 diabetes; amending s. 395.002, F.S.; revising the
32 definition of the terms “accrediting organizations”
33 and “urgent care center” as they relate to hospital
34 licensing and regulation; amending s. 395.003, F.S.;
35 deleting an obsolete provision; authorizing a
36 specialty–licensed children’s hospital that has at
37 least a specified number of licensed neonatal
38 intensive care unit beds to provide obstetrical
39 services that are restricted to the diagnosis, care,
40 and treatment of certain pregnant women; authorizing
41 the Agency for Health Care Administration to adopt
42 rules; amending s. 395.0161, F.S.; deleting a
43 requirement that facilities licensed under part I of
44 ch. 395, F.S., pay licensing fees at the time of
45 inspection; amending s. 395.0193, F.S.; requiring a
46 licensed facility to report certain peer review
47 information and final disciplinary actions to the
48 Division of Medical Quality Assurance of the
49 Department of Health rather than the Division of
50 Health Quality Assurance of the Agency for Health Care
51 Administration; amending s. 395.1023, F.S.; providing
52 for the Department of Children and Family Services
53 rather than the Department of Health to perform
54 certain functions with respect to child protection
55 cases; requiring certain hospitals to notify the
56 Department of Children and Family Services of
57 compliance; amending s. 395.1041, F.S., relating to
58 hospital emergency services and care; deleting
59 obsolete provisions; repealing s. 395.1046, F.S.,
60 relating to complaint investigation procedures;
61 amending s. 395.1055, F.S.; requiring that licensed
62 facility beds conform to standards specified by the
63 Agency for Health Care Administration, the Florida
64 Building Code, and the Florida Fire Prevention Code;
65 amending s. 395.107, F.S.; requiring that urgent care
66 centers publish and post a schedule of charges for
67 services provided to patients; specifying text display
68 requirements; requiring the schedule to be in language
69 comprehensible to a layperson; providing schedule
70 requirements; specifying posting size and allowing for
71 electronic posting; providing an exception; amending
72 s. 400.9935, F.S.; specifying posting size and
73 allowing for electronic posting of a schedule of
74 charges for services provided to patients at a clinic;
75 amending s. 395.3025, F.S.; authorizing the disclosure
76 of patient records to the Department of Health rather
77 than the Agency for Health Care Administration in
78 accordance with an issued subpoena; requiring the
79 department, rather than the agency, to make available,
80 upon written request by a practitioner against whom
81 probable cause has been found, any patient records
82 that form the basis of the determination of probable
83 cause; amending s. 395.3036, F.S.; correcting a cross
84 reference; repealing s. 395.3037, F.S., relating to
85 redundant definitions for the Department of Health and
86 the Agency for Health Care Administration; amending s.
87 395.4025, F.S.; providing an exemption for certain
88 public teaching hospitals operating multiple
89 facilities on separate premises under a single license
90 from the requirement for a separate application for
91 recognition as a trauma center by the Agency for
92 Health Care Administration; amending s. 395.602, F.S.;
93 revising the definition of the term “rural hospital”
94 to delete an obsolete provision; amending s. 400.021,
95 F.S.; revising the definitions of the terms “geriatric
96 outpatient clinic” and “resident care plan”; amending
97 s. 400.275, F.S.; revising agency duties with regard
98 to training nursing home surveyor teams; revising
99 requirements for team members; amending s. 400.474,
100 F.S.; revising the requirements for a quarterly report
101 submitted to the Agency for Health Care Administration
102 by each home health agency; amending s. 400.484, F.S.;
103 revising the classification of violations by a home
104 health agency for which the agency imposes an
105 administrative fine; amending and reenacting s.
106 400.506, F.S., relating to licensure of nurse
107 registries, to incorporate the amendment made to s.
108 400.509, F.S., in a reference thereto; authorizing an
109 administrator to manage up to five nurse registries
110 under certain circumstances; requiring an
111 administrator to designate, in writing, for each
112 licensed entity, a qualified alternate administrator
113 to serve during the administrator’s absence; amending
114 s. 400.509, F.S.; providing that organizations that
115 provide companion services only to persons with
116 developmental disabilities, under contract with the
117 Agency for Persons with Disabilities, are exempt from
118 registration with the Agency for Health Care
119 Administration; amending s. 400.601, F.S.; redefining
120 the term “hospice” to include a limited liability
121 company as it relates to nursing homes and related
122 health care facilities; amending s. 400.606, F.S.;
123 revising the content requirements of the plan
124 accompanying an initial or change-of-ownership
125 application for licensure of a hospice; revising
126 requirements relating to certificates of need for
127 certain hospice facilities; amending s. 400.915, F.S.;
128 correcting an obsolete cross-reference to
129 administrative rules; amending s. 400.931, F.S.;
130 requiring each applicant for initial licensure, change
131 of ownership, or license renewal to operate a licensed
132 home medical equipment provider at a location outside
133 the state to submit documentation of accreditation, or
134 an application for accreditation, from an accrediting
135 organization that is recognized by the Agency for
136 Health Care Administration; requiring an applicant
137 that has applied for accreditation to provide proof of
138 accreditation within a specified time; deleting a
139 requirement that an applicant for a home medical
140 equipment provider license submit a surety bond to the
141 agency; amending s. 400.967, F.S.; revising the
142 classification of violations by intermediate care
143 facilities for the developmentally disabled; providing
144 a penalty for certain violations; amending s.
145 400.9905, F.S.; revising the definitions of the terms
146 “clinic” and “portable equipment provider”;
147 authorizing the Agency for Health Care Administration
148 to deny or revoke an exemption from licensure based on
149 certain criteria if a health care clinic receives
150 payment for health care services under personal injury
151 protection insurance coverage; including health
152 services provided at multiple locations within the
153 definition of the term “portable health service or
154 equipment provider”; amending s. 400.991, F.S.;
155 conforming terminology; revising application
156 requirements relating to documentation of financial
157 ability to operate a mobile clinic; amending s.
158 408.033, F.S.; providing that fees assessed on
159 selected health care facilities and organizations may
160 be collected prospectively at the time of licensure
161 renewal and prorated for the licensing period;
162 amending s. 408.034, F.S.; revising agency authority
163 relating to licensing of intermediate care facilities
164 for the developmentally disabled; amending s. 408.036,
165 F.S.; deleting an exemption from certain certificate
166 of-need review requirements for a hospice or a hospice
167 inpatient facility; amending s. 408.037, F.S.;
168 revising requirements for the financial information to
169 be included in an application for a certificate of
170 need; amending s. 408.043, F.S.; revising requirements
171 for certain freestanding inpatient hospice care
172 facilities to obtain a certificate of need; amending
173 s. 408.061, F.S.; revising data reporting requirements
174 for health care facilities; amending s. 408.07, F.S.;
175 deleting a cross-reference; amending s. 408.10, F.S.;
176 removing agency authority to investigate certain
177 consumer complaints; amending s. 408.7056, F.S.;
178 providing that the Subscriber Assistance Program
179 applies to health plans that meet certain
180 requirements; repealing s. 408.802(11), F.S.; removing
181 applicability of part II of ch. 408, F.S., relating to
182 general licensure requirements, to private review
183 agents; amending s. 408.804, F.S.; providing penalties
184 for altering, defacing, or falsifying a license
185 certificate issued by the agency or displaying such an
186 altered, defaced, or falsified certificate; amending
187 s. 408.806, F.S.; revising agency responsibilities for
188 notification of licensees of impending expiration of a
189 license; requiring payment of a late fee for a license
190 application to be considered complete under certain
191 circumstances; amending s. 408.8065, F.S.; revising
192 the requirements for becoming licensed as a home
193 health agency, home medical equipment provider, or
194 health care clinic; amending s. 408.809, F.S.;
195 revising provisions to include a schedule for
196 background rescreenings of certain employees; amending
197 s. 408.810, F.S.; requiring that the controlling
198 interest of a health care licensee notify the agency
199 of certain court proceedings; providing a penalty;
200 amending s. 408.813, F.S.; authorizing the agency to
201 impose fines for unclassified violations of part II of
202 ch. 408, F.S.; amending s. 409.912, F.S.; revising the
203 components of the Medicaid prescribed-drug spending
204 control program; amending s. 409.91195, F.S.; revising
205 the membership of the Medicaid Pharmaceutical and
206 Therapeutics Committee; providing the requirements for
207 the members; providing terms of membership; requiring
208 the Agency for Health Care Administration to serve as
209 staff for the committee and assist the committee with
210 its duties; providing additional requirements for
211 presenting public testimony to include a product on a
212 preferred drug list; requiring that the committee be
213 informed in writing of the agency’s action when the
214 agency does not follow the recommendation of the
215 committee; repealing s. 429.11(6), F.S., relating to
216 provisional licenses for assisted living facilities;
217 amending s. 429.294, F.S.; revising a cross-reference;
218 amending s. 429.71, F.S.; revising the classification
219 of violations; amending s. 429.915, F.S.; revising
220 agency responsibilities regarding the issuance of
221 conditional licenses; amending ss. 430.80 and 430.81,
222 F.S.; conforming cross-references; repealing s.
223 440.102(9)(d), F.S., relating to a requirement that
224 laboratories submit to the Agency for Health Care
225 Administration a monthly report containing statistical
226 information regarding the testing of employees and job
227 applicants; amending s. 465.014, F.S.; providing that
228 the provisions governing pharmacy technicians do not
229 apply to a practitioner authorized to dispense drugs
230 or a medical assistant or licensed health care
231 professional acting under the direct supervision of
232 such a practitioner under certain circumstances;
233 amending s. 483.035, F.S.; providing for a clinical
234 laboratory to be operated by certain nurses; amending
235 s. 483.051, F.S.; requiring the Agency for Health Care
236 Administration to provide for biennial licensure of
237 all nonwaived laboratories that meet certain
238 requirements; requiring the agency to prescribe
239 qualifications for such licensure; defining nonwaived
240 laboratories as laboratories that do not have a
241 certificate of waiver from the Centers for Medicare
242 and Medicaid Services; deleting requirements for the
243 registration of an alternate site testing location
244 when the clinical laboratory applies to renew its
245 license; amending s. 483.245, F.S.; prohibiting a
246 clinical laboratory from placing a specimen collector
247 or other personnel in any physician’s office, unless
248 the clinical lab and the physician’s office are owned
249 and operated by the same entity; authorizing a person
250 who is aggrieved by a violation to bring a civil
251 action for appropriate relief; amending s. 483.294,
252 F.S.; revising the frequency of agency inspections of
253 multiphasic health testing centers; amending s.
254 499.003, F.S.; redefining the term “wholesale
255 distribution” with regard to the Florida Drug and
256 Cosmetic Act to remove certain requirements governing
257 prescription drug inventories; creating s. 624.49,
258 F.S.; prohibiting a managed care entity, insurance
259 carrier, self-insured entity, or third-party
260 administrator, or an agent thereof, from imposing a
261 contracted reimbursement rate on a medical provider
262 for certain goods or services unless the carrier
263 directly contracts with the provider for that rate;
264 amending and creating, respectively, ss. 627.602 and
265 627.6513, F.S.; providing that the Uniform Health
266 Carrier External Review Model Act and the Employee
267 Retirement Income Security Act apply to individual and
268 group health insurance policies except those subject
269 to the Subscriber Assistance Program under s.
270 408.7056, F.S.; creating s. 641.312, F.S.; requiring
271 the Financial Services Commission to adopt rules to
272 administer the National Association of Insurance
273 Commissioners’ Uniform Health Carrier External Review
274 Model Act; providing that the Uniform Health Carrier
275 External Review Model Act does not apply to a health
276 maintenance contract that is subject to the Subscriber
277 Assistance Program under s. 408.7056, F.S.; amending
278 s. 651.118, F.S.; conforming a cross-reference;
279 providing a directive to the Division of Statutory
280 Revision; providing effective dates.
281
282 Be It Enacted by the Legislature of the State of Florida:
283
284 Section 1. Subsection (1) of section 83.42, Florida
285 Statutes, is amended to read:
286 83.42 Exclusions from application of part.—This part does
287 not apply to:
288 (1) Residency or detention in a facility, whether public or
289 private, when residence or detention is incidental to the
290 provision of medical, geriatric, educational, counseling,
291 religious, or similar services. For residents of a facility
292 licensed under part II of chapter 400, the provisions of s.
293 400.0255 are the exclusive procedures for all transfers and
294 discharges.
295 Section 2. Present paragraphs (f) through (k) of subsection
296 (10) of section 112.0455, Florida Statutes, are redesignated as
297 paragraphs (e) through (j), respectively, and present paragraph
298 (e) of subsection (10), subsection (12), and paragraph (e) of
299 subsection (14) of that section are amended to read:
300 112.0455 Drug-Free Workplace Act.—
301 (10) EMPLOYER PROTECTION.—
302 (e) Nothing in this section shall be construed to operate
303 retroactively, and nothing in this section shall abrogate the
304 right of an employer under state law to conduct drug tests prior
305 to January 1, 1990. A drug test conducted by an employer prior
306 to January 1, 1990, is not subject to this section.
307 (12) DRUG-TESTING STANDARDS; LABORATORIES.—
308 (a) The requirements of part II of chapter 408 apply to the
309 provision of services that require licensure pursuant to this
310 section and part II of chapter 408 and to entities licensed by
311 or applying for such licensure from the Agency for Health Care
312 Administration pursuant to this section. A license issued by the
313 agency is required in order to operate a laboratory.
314 (b) A laboratory may analyze initial or confirmation drug
315 specimens only if:
316 1. The laboratory is licensed and approved by the Agency
317 for Health Care Administration using criteria established by the
318 United States Department of Health and Human Services as general
319 guidelines for modeling the state drug testing program and in
320 accordance with part II of chapter 408. Each applicant for
321 licensure and licensee must comply with all requirements of part
322 II of chapter 408.
323 2. The laboratory has written procedures to ensure chain of
324 custody.
325 3. The laboratory follows proper quality control
326 procedures, including, but not limited to:
327 a. The use of internal quality controls including the use
328 of samples of known concentrations which are used to check the
329 performance and calibration of testing equipment, and periodic
330 use of blind samples for overall accuracy.
331 b. An internal review and certification process for drug
332 test results, conducted by a person qualified to perform that
333 function in the testing laboratory.
334 c. Security measures implemented by the testing laboratory
335 to preclude adulteration of specimens and drug test results.
336 d. Other necessary and proper actions taken to ensure
337 reliable and accurate drug test results.
338 (c) A laboratory shall disclose to the employer a written
339 test result report within 7 working days after receipt of the
340 sample. All laboratory reports of a drug test result shall, at a
341 minimum, state:
342 1. The name and address of the laboratory which performed
343 the test and the positive identification of the person tested.
344 2. Positive results on confirmation tests only, or negative
345 results, as applicable.
346 3. A list of the drugs for which the drug analyses were
347 conducted.
348 4. The type of tests conducted for both initial and
349 confirmation tests and the minimum cutoff levels of the tests.
350 5. Any correlation between medication reported by the
351 employee or job applicant pursuant to subparagraph (8)(b)2. and
352 a positive confirmed drug test result.
353
354 A No report may not shall disclose the presence or absence of
355 any drug other than a specific drug and its metabolites listed
356 pursuant to this section.
357 (d) The laboratory shall submit to the Agency for Health
358 Care Administration a monthly report with statistical
359 information regarding the testing of employees and job
360 applicants. The reports shall include information on the methods
361 of analyses conducted, the drugs tested for, the number of
362 positive and negative results for both initial and confirmation
363 tests, and any other information deemed appropriate by the
364 Agency for Health Care Administration. No monthly report shall
365 identify specific employees or job applicants.
366 (d)(e) Laboratories shall provide technical assistance to
367 the employer, employee, or job applicant for the purpose of
368 interpreting any positive confirmed test results which could
369 have been caused by prescription or nonprescription medication
370 taken by the employee or job applicant.
371 (14) DISCIPLINE REMEDIES.—
372 (e) Upon resolving an appeal filed pursuant to paragraph
373 (c), and finding a violation of this section, the commission may
374 order the following relief:
375 1. Rescind the disciplinary action, expunge related records
376 from the personnel file of the employee or job applicant and
377 reinstate the employee.
378 2. Order compliance with paragraph (10)(f) (10)(g).
379 3. Award back pay and benefits.
380 4. Award the prevailing employee or job applicant the
381 necessary costs of the appeal, reasonable attorney’s fees, and
382 expert witness fees.
383 Section 3. Subsection (15) of section 318.21, Florida
384 Statutes, is amended to read:
385 318.21 Disposition of civil penalties by county courts.—All
386 civil penalties received by a county court pursuant to the
387 provisions of this chapter shall be distributed and paid monthly
388 as follows:
389 (15) Of the additional fine assessed under s. 318.18(3)(e)
390 for a violation of s. 316.1893, 50 percent of the moneys
391 received from the fines shall be remitted to the Department of
392 Revenue and deposited into the Brain and Spinal Cord Injury
393 Trust Fund of Department of Health and appropriated to the
394 Department of Health Agency for Health Care Administration as
395 general revenue to provide an enhanced Medicaid payment to
396 nursing homes that serve Medicaid recipients who have with brain
397 and spinal cord injuries that are medically complex and who are
398 technologically and respiratory dependent. The remaining 50
399 percent of the moneys received from the enhanced fine imposed
400 under s. 318.18(3)(e) shall be remitted to the Department of
401 Revenue and deposited into the Department of Health Emergency
402 Medical Services Trust Fund to provide financial support to
403 certified trauma centers in the counties where enhanced penalty
404 zones are established to ensure the availability and
405 accessibility of trauma services. Funds deposited into the
406 Emergency Medical Services Trust Fund under this subsection
407 shall be allocated as follows:
408 (a) Fifty percent shall be allocated equally among all
409 Level I, Level II, and pediatric trauma centers in recognition
410 of readiness costs for maintaining trauma services.
411 (b) Fifty percent shall be allocated among Level I, Level
412 II, and pediatric trauma centers based on each center’s relative
413 volume of trauma cases as reported in the Department of Health
414 Trauma Registry.
415 Section 4. Section 383.325, Florida Statutes, is repealed.
416 Section 5. Section 385.2031, Florida Statutes, is created
417 to read:
418 385.2031 Resource for research in the prevention and
419 treatment of diabetes.—The Florida Hospital/Sanford-Burnham
420 Translational Research Institute for Metabolism and Diabetes is
421 designated as a resource in this state for research in the
422 prevention and treatment of diabetes.
423 Section 6. Subsections (1) and (30) of section 395.002,
424 Florida Statutes, are amended to read:
425 395.002 Definitions.—As used in this chapter:
426 (1) “Accrediting organizations” means national
427 accreditation organizations that are approved by the Centers for
428 Medicare and Medicaid Services and whose standards incorporate
429 comparable licensure regulations required by the state the Joint
430 Commission on Accreditation of Healthcare Organizations, the
431 American Osteopathic Association, the Commission on
432 Accreditation of Rehabilitation Facilities, and the
433 Accreditation Association for Ambulatory Health Care, Inc.
434 (30) “Urgent care center” means a facility or clinic that
435 provides immediate but not emergent ambulatory medical care to
436 patients with or without an appointment. The term includes an
437 offsite It does not include the emergency department of a
438 hospital which is presented to the general public in any manner
439 as a department where immediate and not only emergent medical
440 care is provided. The term includes a facility offsite of a
441 facility licensed under this chapter, or a joint venture between
442 a facility licensed under this chapter and a provider licensed
443 under chapter 458 or chapter 459, which does not require a
444 patient to make an appointment and is presented to the general
445 public in any manner as a facility where immediate but not
446 emergent medical care is provided. The term includes a clinic
447 organization, licensed under part X of chapter 400, which
448 maintains three or more locations using the same or similar
449 name, does not require a patient to make an appointment, and
450 holds itself out to the general public in any manner as a
451 facility or clinic where immediate but not emergent medical care
452 is provided.
453 Section 7. Paragraph (c) of subsection (1) and subsection
454 (6) of section 395.003, Florida Statutes, are amended to read:
455 395.003 Licensure; denial, suspension, and revocation.—
456 (1)
457 (c) Until July 1, 2006, additional emergency departments
458 located off the premises of licensed hospitals may not be
459 authorized by the agency.
460 (6) A specialty hospital may not provide any service or
461 regularly serve any population group beyond those services or
462 groups specified in its license. A specialty-licensed children’s
463 hospital that is authorized to provide pediatric cardiac
464 catheterization and pediatric open-heart surgery services may
465 provide cardiovascular service to adults who, as children, were
466 previously served by the hospital for congenital heart disease,
467 or to those patients who are referred for a specialized
468 procedure only for congenital heart disease by an adult
469 hospital, without obtaining additional licensure as a provider
470 of adult cardiovascular services. The agency may request
471 documentation as needed to support patient selection and
472 treatment. This subsection does not apply to a specialty
473 licensed children’s hospital that is already licensed to provide
474 adult cardiovascular services. A specialty–licensed children’s
475 hospital that has at least 50 licensed neonatal intensive care
476 unit beds may provide obstetrical services, including labor and
477 delivery, which are restricted to the diagnosis, care, and
478 treatment of pregnant women of any age who have:
479 (a) At least one maternal or fetal characteristic or
480 condition that would characterize the pregnancy or delivery as
481 high-risk; or
482 (b) Received medical advice or a diagnosis indicating their
483 fetus will require at least one perinatal intervention.
484
485 The agency shall adopt rules that establish standards and
486 guidelines for admission to any program that qualifies under
487 this subsection.
488 Section 8. Subsection (3) of section 395.0161, Florida
489 Statutes, is amended to read:
490 395.0161 Licensure inspection.—
491 (3) In accordance with s. 408.805, an applicant or licensee
492 shall pay a fee for each license application submitted under
493 this part, part II of chapter 408, and applicable rules. With
494 the exception of state-operated licensed facilities, each
495 facility licensed under this part shall pay to the agency, at
496 the time of inspection, the following fees:
497 (a) Inspection for licensure.—A fee shall be paid which is
498 not less than $8 per hospital bed, nor more than $12 per
499 hospital bed, except that the minimum fee shall be $400 per
500 facility.
501 (b) Inspection for lifesafety only.—A fee shall be paid
502 which is not less than 75 cents per hospital bed, nor more than
503 $1.50 per hospital bed, except that the minimum fee shall be $40
504 per facility.
505 Section 9. Subsections (2) and (4) of section 395.0193,
506 Florida Statutes, are amended to read:
507 395.0193 Licensed facilities; peer review; disciplinary
508 powers; agency or partnership with physicians.—
509 (2) Each licensed facility, as a condition of licensure,
510 shall provide for peer review of physicians who deliver health
511 care services at the facility. Each licensed facility shall
512 develop written, binding procedures by which such peer review
513 shall be conducted. Such procedures must shall include:
514 (a) Mechanism for choosing the membership of the body or
515 bodies that conduct peer review.
516 (b) Adoption of rules of order for the peer review process.
517 (c) Fair review of the case with the physician involved.
518 (d) Mechanism to identify and avoid conflict of interest on
519 the part of the peer review panel members.
520 (e) Recording of agendas and minutes which do not contain
521 confidential material, for review by the Division of Medical
522 Quality Assurance of the department Health Quality Assurance of
523 the agency.
524 (f) Review, at least annually, of the peer review
525 procedures by the governing board of the licensed facility.
526 (g) Focus of the peer review process on review of
527 professional practices at the facility to reduce morbidity and
528 mortality and to improve patient care.
529 (4) Pursuant to ss. 458.337 and 459.016, any disciplinary
530 actions taken under subsection (3) shall be reported in writing
531 to the Division of Medical Quality Assurance of the department
532 Health Quality Assurance of the agency within 30 working days
533 after its initial occurrence, regardless of the pendency of
534 appeals to the governing board of the hospital. The notification
535 shall identify the disciplined practitioner, the action taken,
536 and the reason for such action. All final disciplinary actions
537 taken under subsection (3), if different from those which were
538 reported to the department agency within 30 days after the
539 initial occurrence, shall be reported within 10 working days to
540 the Division of Medical Quality Assurance of the department
541 Health Quality Assurance of the agency in writing and shall
542 specify the disciplinary action taken and the specific grounds
543 therefor. The division shall review each report and determine
544 whether it potentially involved conduct by the licensee that is
545 subject to disciplinary action, in which case s. 456.073 shall
546 apply. The reports are not subject to inspection under s.
547 119.07(1) even if the division’s investigation results in a
548 finding of probable cause.
549 Section 10. Section 395.1023, Florida Statutes, is amended
550 to read:
551 395.1023 Child abuse and neglect cases; duties.—Each
552 licensed facility shall adopt a protocol that, at a minimum,
553 requires the facility to:
554 (1) Incorporate a facility policy that every staff member
555 has an affirmative duty to report, pursuant to chapter 39, any
556 actual or suspected case of child abuse, abandonment, or
557 neglect; and
558 (2) In any case involving suspected child abuse,
559 abandonment, or neglect, designate, at the request of the
560 Department of Children and Family Services, a staff physician to
561 act as a liaison between the hospital and the Department of
562 Children and Family Services office which is investigating the
563 suspected abuse, abandonment, or neglect, and the child
564 protection team, as defined in s. 39.01, when the case is
565 referred to such a team.
566
567 Each general hospital and appropriate specialty hospital shall
568 comply with the provisions of this section and shall notify the
569 agency and the Department of Children and Family Services of its
570 compliance by sending a copy of its policy to the agency and the
571 Department of Children and Family Services as required by rule.
572 The failure by a general hospital or appropriate specialty
573 hospital to comply shall be punished by a fine not exceeding
574 $1,000, to be fixed, imposed, and collected by the agency. Each
575 day in violation is considered a separate offense.
576 Section 11. Subsection (2) and paragraph (d) of subsection
577 (3) of section 395.1041, Florida Statutes, are amended to read:
578 395.1041 Access to emergency services and care.—
579 (2) INVENTORY OF HOSPITAL EMERGENCY SERVICES.—The agency
580 shall establish and maintain an inventory of hospitals with
581 emergency services. The inventory shall list all services within
582 the service capability of the hospital, and such services shall
583 appear on the face of the hospital license. Each hospital having
584 emergency services shall notify the agency of its service
585 capability in the manner and form prescribed by the agency. The
586 agency shall use the inventory to assist emergency medical
587 services providers and others in locating appropriate emergency
588 medical care. The inventory shall also be made available to the
589 general public. On or before August 1, 1992, the agency shall
590 request that each hospital identify the services which are
591 within its service capability. On or before November 1, 1992,
592 the agency shall notify each hospital of the service capability
593 to be included in the inventory. The hospital has 15 days from
594 the date of receipt to respond to the notice. By December 1,
595 1992, the agency shall publish a final inventory. Each hospital
596 shall reaffirm its service capability when its license is
597 renewed and shall notify the agency of the addition of a new
598 service or the termination of a service prior to a change in its
599 service capability.
600 (3) EMERGENCY SERVICES; DISCRIMINATION; LIABILITY OF
601 FACILITY OR HEALTH CARE PERSONNEL.—
602 (d)1. Every hospital shall ensure the provision of services
603 within the service capability of the hospital, at all times,
604 either directly or indirectly through an arrangement with
605 another hospital, through an arrangement with one or more
606 physicians, or as otherwise made through prior arrangements. A
607 hospital may enter into an agreement with another hospital for
608 purposes of meeting its service capability requirement, and
609 appropriate compensation or other reasonable conditions may be
610 negotiated for these backup services.
611 2. If any arrangement requires the provision of emergency
612 medical transportation, such arrangement must be made in
613 consultation with the applicable provider and may not require
614 the emergency medical service provider to provide transportation
615 that is outside the routine service area of that provider or in
616 a manner that impairs the ability of the emergency medical
617 service provider to timely respond to prehospital emergency
618 calls.
619 3. A hospital is shall not be required to ensure service
620 capability at all times as required in subparagraph 1. if, prior
621 to the receiving of any patient needing such service capability,
622 such hospital has demonstrated to the agency that it lacks the
623 ability to ensure such capability and it has exhausted all
624 reasonable efforts to ensure such capability through backup
625 arrangements. In reviewing a hospital’s demonstration of lack of
626 ability to ensure service capability, the agency shall consider
627 factors relevant to the particular case, including the
628 following:
629 a. Number and proximity of hospitals with the same service
630 capability.
631 b. Number, type, credentials, and privileges of
632 specialists.
633 c. Frequency of procedures.
634 d. Size of hospital.
635 4. The agency shall publish proposed rules implementing a
636 reasonable exemption procedure by November 1, 1992. Subparagraph
637 1. shall become effective upon the effective date of said rules
638 or January 31, 1993, whichever is earlier. For a period not to
639 exceed 1 year from the effective date of subparagraph 1., a
640 hospital requesting an exemption shall be deemed to be exempt
641 from offering the service until the agency initially acts to
642 deny or grant the original request. The agency has 45 days after
643 from the date of receipt of the request to approve or deny the
644 request. After the first year from the effective date of
645 subparagraph 1., If the agency fails to initially act within
646 that the time period, the hospital is deemed to be exempt from
647 offering the service until the agency initially acts to deny the
648 request.
649 Section 12. Section 395.1046, Florida Statutes, is
650 repealed.
651 Section 13. Paragraph (e) of subsection (1) of section
652 395.1055, Florida Statutes, is amended to read:
653 395.1055 Rules and enforcement.—
654 (1) The agency shall adopt rules pursuant to ss. 120.536(1)
655 and 120.54 to implement the provisions of this part, which shall
656 include reasonable and fair minimum standards for ensuring that:
657 (e) Licensed facility beds conform to minimum space,
658 equipment, and furnishings standards as specified by the agency,
659 the Florida Building Code, and the Florida Fire Prevention Code
660 department.
661 Section 14. Section 395.107, Florida Statutes, is amended
662 to read:
663 395.107 Urgent care centers; Publishing and posting
664 schedule of charges; penalties.—
665 (1) An urgent care center must publish and post a schedule
666 of charges for the medical services offered to patients.
667 (2) The schedule of charges must describe the medical
668 services in language comprehensible to a layperson. The schedule
669 must include the prices charged to an uninsured person paying
670 for such services by cash, check, credit card, or debit card.
671 The schedule must be posted in a conspicuous place in the
672 reception area of the urgent care center and must include, but
673 is not limited to, the 50 services most frequently provided by
674 the urgent care center. The schedule may group services by three
675 price levels, listing services in each price level. The posting
676 may be a sign that must be at least 15 square feet in size or an
677 electronic messaging board. If an urgent care center is
678 affiliated with a facility licensed under this chapter, the
679 schedule must include text that notifies an insured patient
680 whether the charges for medical services received at the center
681 are the same as, or more than, charges for medical services
682 received at an affiliated hospital. The text notifying the
683 patient shall be in a font size equal to or greater than the
684 font size used for prices and must be in a contrasting color.
685 Such text shall be included in all media and Internet
686 advertisements for the center and in language comprehensible to
687 a layperson.
688 (3) The posted text describing the medical services must
689 fill at least 12 square feet of the posting. A center may use an
690 electronic device or a messaging board to post the schedule of
691 charges. Such devices must measure at least 3 square feet, and
692 patients must be able to access the schedule during all hours of
693 operation.
694 (4) An urgent care center that is operated and used
695 exclusively for employees and the dependents of employees of the
696 business that owns or contracts for the urgent care center is
697 exempt from this section.
698 (5) The failure of an urgent care center to publish and
699 post a schedule of charges as required by this section shall
700 result in a fine of not more than $1,000, per day, until the
701 schedule is published and posted.
702 Section 15. Paragraph (i) of subsection (1) of section
703 400.9935, Florida Statutes, is amended to read:
704 400.9935 Clinic responsibilities.—
705 (1) Each clinic shall appoint a medical director or clinic
706 director who shall agree in writing to accept legal
707 responsibility for the following activities on behalf of the
708 clinic. The medical director or the clinic director shall:
709 (i) Ensure that the clinic publishes a schedule of charges
710 for the medical services offered to patients. The schedule must
711 include the prices charged to an uninsured person paying for
712 such services by cash, check, credit card, or debit card. The
713 schedule must be posted in a conspicuous place in the reception
714 area of the urgent care center and must include, but is not
715 limited to, the 50 services most frequently provided by the
716 clinic. The schedule may group services by three price levels,
717 listing services in each price level. The posting may be a sign
718 that must be at least 15 square feet in size or an electronic
719 messaging board that must be at least 3 square feet. The failure
720 of a clinic to publish and post a schedule of charges as
721 required by this section shall result in a fine of not more than
722 $1,000, per day, until the schedule is published and posted.
723 Section 16. Paragraph (e) of subsection (4) of section
724 395.3025, Florida Statutes, is amended to read:
725 395.3025 Patient and personnel records; copies;
726 examination.—
727 (4) Patient records are confidential and must not be
728 disclosed without the consent of the patient or his or her legal
729 representative, but appropriate disclosure may be made without
730 such consent to:
731 (e) The department agency upon subpoena issued pursuant to
732 s. 456.071., but The records obtained thereby must be used
733 solely for the purpose of the agency, the department, and the
734 appropriate professional board in an its investigation,
735 prosecution, and appeal of disciplinary proceedings. If the
736 department agency requests copies of the records, the facility
737 shall charge a fee pursuant to this section no more than its
738 actual copying costs, including reasonable staff time. The
739 records must be sealed and must not be available to the public
740 pursuant to s. 119.07(1) or any other statute providing access
741 to records, nor may they be available to the public as part of
742 the record of investigation for and prosecution in disciplinary
743 proceedings made available to the public by the agency, the
744 department, or the appropriate regulatory board. However, the
745 department agency must make available, upon written request by a
746 practitioner against whom probable cause has been found, any
747 such records that form the basis of the determination of
748 probable cause.
749 Section 17. Subsection (2) of section 395.3036, Florida
750 Statutes, is amended to read:
751 395.3036 Confidentiality of records and meetings of
752 corporations that lease public hospitals or other public health
753 care facilities.—The records of a private corporation that
754 leases a public hospital or other public health care facility
755 are confidential and exempt from the provisions of s. 119.07(1)
756 and s. 24(a), Art. I of the State Constitution, and the meetings
757 of the governing board of a private corporation are exempt from
758 s. 286.011 and s. 24(b), Art. I of the State Constitution when
759 the public lessor complies with the public finance
760 accountability provisions of s. 155.40(5) with respect to the
761 transfer of any public funds to the private lessee and when the
762 private lessee meets at least three of the five following
763 criteria:
764 (2) The public lessor and the private lessee do not
765 commingle any of their funds in any account maintained by either
766 of them, other than the payment of the rent and administrative
767 fees or the transfer of funds pursuant to s. 155.40 subsection
768 (2).
769 Section 18. Section 395.3037, Florida Statutes, is
770 repealed.
771 Section 19. Subsection (15) is added to section 395.4025,
772 Florida Statutes, to read:
773 395.4025 Trauma centers; selection; quality assurance;
774 records.—
775 (15) A public teaching hospital that operates facilities on
776 separate premises under a single license and that has a level 1
777 trauma center on one of the premises is exempt from the
778 requirements of subsection (2) and a separate application is not
779 required for the initiation of trauma services at another
780 facility included on the single license, subject to the
781 following:
782 (a) The hospital must certify to the agency that it will
783 meet and continuously maintain the critical elements required
784 for a trauma center, including, but not limited to:
785 1. The equipment and physical facilities necessary to
786 provide trauma services;
787 2. The personnel in sufficient numbers and having proper
788 qualifications to provide trauma services; and
789 3. An effective quality assurance process.
790 (b) The hospital must provide documentation to the agency
791 of the manner in which it will extend its existing trauma
792 services to the additional hospital facility listed on the
793 single hospital license.
794 (c) The hospital must provide further documentation to the
795 agency that demonstrates there were at least 350 trauma cases
796 within a 5-mile radius of the location of the facility for which
797 the exemption is claimed during the most recent 12-month period
798 for which data is available, by the zip code of:
799 1. The patient’s residence as reported by the agency
800 hospital patient database; or
801 2. Where the incident occurred, as reported by the
802 emergency medical services provider.
803 Section 20. Paragraph (e) of subsection (2) of section
804 395.602, Florida Statutes, is amended to read:
805 395.602 Rural hospitals.—
806 (2) DEFINITIONS.—As used in this part:
807 (e) “Rural hospital” means an acute care hospital licensed
808 under this chapter, having 100 or fewer licensed beds and an
809 emergency room, which is:
810 1. The sole provider within a county with a population
811 density of no greater than 100 persons per square mile;
812 2. An acute care hospital, in a county with a population
813 density of no greater than 100 persons per square mile, which is
814 at least 30 minutes of travel time, on normally traveled roads
815 under normal traffic conditions, from any other acute care
816 hospital within the same county;
817 3. A hospital supported by a tax district or subdistrict
818 whose boundaries encompass a population of 100 persons or fewer
819 per square mile;
820 4. A hospital in a constitutional charter county with a
821 population of over 1 million persons that has imposed a local
822 option health service tax pursuant to law and in an area that
823 was directly impacted by a catastrophic event on August 24,
824 1992, for which the Governor of Florida declared a state of
825 emergency pursuant to chapter 125, and has 120 beds or less that
826 serves an agricultural community with an emergency room
827 utilization of no less than 20,000 visits and a Medicaid
828 inpatient utilization rate greater than 15 percent;
829 4.5. A hospital with a service area that has a population
830 of 100 persons or fewer per square mile. As used in this
831 subparagraph, the term “service area” means the fewest number of
832 zip codes that account for 75 percent of the hospital’s
833 discharges for the most recent 5-year period, based on
834 information available from the hospital inpatient discharge
835 database in the Florida Center for Health Information and Policy
836 Analysis at the Agency for Health Care Administration; or
837 5.6. A hospital designated as a critical access hospital,
838 as defined in s. 408.07(15).
839
840 Population densities used in this paragraph must be based upon
841 the most recently completed United States census. A hospital
842 that received funds under s. 409.9116 for a quarter beginning no
843 later than July 1, 2002, is deemed to have been and shall
844 continue to be a rural hospital from that date through June 30,
845 2015, if the hospital continues to have 100 or fewer licensed
846 beds and an emergency room, or meets the criteria of
847 subparagraph 4. An acute care hospital that has not previously
848 been designated as a rural hospital and that meets the criteria
849 of this paragraph shall be granted such designation upon
850 application, including supporting documentation to the Agency
851 for Health Care Administration.
852 Section 21. Subsections (8) and (16) of section 400.021,
853 Florida Statutes, are amended to read:
854 400.021 Definitions.—When used in this part, unless the
855 context otherwise requires, the term:
856 (8) “Geriatric outpatient clinic” means a site for
857 providing outpatient health care to persons 60 years of age or
858 older, which is staffed by a registered nurse or a physician
859 assistant, or by a licensed practical nurse who is under the
860 direct supervision of a registered nurse, an advanced registered
861 nurse practitioner, a physician assistant, or a physician.
862 (16) “Resident care plan” means a written plan developed,
863 maintained, and reviewed not less than quarterly by a registered
864 nurse, with participation from other facility staff and the
865 resident or his or her designee or legal representative, which
866 includes a comprehensive assessment of the needs of an
867 individual resident; the type and frequency of services required
868 to provide the necessary care for the resident to attain or
869 maintain the highest practicable physical, mental, and
870 psychosocial well-being; a listing of services provided within
871 or outside the facility to meet those needs; and an explanation
872 of service goals. The resident care plan must be signed by the
873 director of nursing or another registered nurse employed by the
874 facility to whom institutional responsibilities have been
875 delegated and by the resident, the resident’s designee, or the
876 resident’s legal representative. The facility may not use an
877 agency or temporary registered nurse to satisfy the foregoing
878 requirement and must document the institutional responsibilities
879 that have been delegated to the registered nurse.
880 Section 22. Subsection (1) of section 400.275, Florida
881 Statutes, is amended to read:
882 400.275 Agency duties.—
883 (1) The agency shall ensure that each newly hired nursing
884 home surveyor, as a part of basic training, is assigned full
885 time to a licensed nursing home for at least 2 days within a 7
886 day period to observe facility operations outside of the survey
887 process before the surveyor begins survey responsibilities. Such
888 observations may not be the sole basis of a deficiency citation
889 against the facility. The agency may not assign an individual to
890 be a member of a survey team for purposes of a survey,
891 evaluation, or consultation visit at a nursing home facility in
892 which the surveyor was an employee within the preceding 2 5
893 years.
894 Section 23. Subsection (6) of section 400.474, Florida
895 Statutes, is amended, present subsection (7) is redesignated as
896 subsection (8), and a new subsection (7) is added to that
897 section, to read:
898 400.474 Administrative penalties.—
899 (6) The agency may deny, revoke, or suspend the license of
900 a home health agency and shall impose a fine of $5,000 against a
901 home health agency that:
902 (a) Gives remuneration for staffing services to:
903 1. Another home health agency with which it has formal or
904 informal patient-referral transactions or arrangements; or
905 2. A health services pool with which it has formal or
906 informal patient-referral transactions or arrangements,
907
908 unless the home health agency has activated its comprehensive
909 emergency management plan in accordance with s. 400.492. This
910 paragraph does not apply to a Medicare-certified home health
911 agency that provides fair market value remuneration for staffing
912 services to a non-Medicare-certified home health agency that is
913 part of a continuing care facility licensed under chapter 651
914 for providing services to its own residents if each resident
915 receiving home health services pursuant to this arrangement
916 attests in writing that he or she made a decision without
917 influence from staff of the facility to select, from a list of
918 Medicare-certified home health agencies provided by the
919 facility, that Medicare-certified home health agency to provide
920 the services.
921 (b) Provides services to residents in an assisted living
922 facility for which the home health agency does not receive fair
923 market value remuneration.
924 (c) Provides staffing to an assisted living facility for
925 which the home health agency does not receive fair market value
926 remuneration.
927 (d) Fails to provide the agency, upon request, with copies
928 of all contracts with assisted living facilities which were
929 executed within 5 years before the request.
930 (e) Gives remuneration to a case manager, discharge
931 planner, facility-based staff member, or third-party vendor who
932 is involved in the discharge planning process of a facility
933 licensed under chapter 395, chapter 429, or this chapter from
934 whom the home health agency receives referrals.
935 (f) Fails to submit to the agency, within 15 days after the
936 end of each calendar quarter, a written report that includes the
937 following data based on data as it existed on the last day of
938 the quarter:
939 1. The number of insulin-dependent diabetic patients
940 receiving insulin-injection services from the home health
941 agency;
942 2. The number of patients receiving both home health
943 services from the home health agency and hospice services;
944 3. The number of patients receiving home health services
945 from that home health agency; and
946 4. The names and license numbers of nurses whose primary
947 job responsibility is to provide home health services to
948 patients and who received remuneration from the home health
949 agency in excess of $25,000 during the calendar quarter.
950 (f)(g) Gives cash, or its equivalent, to a Medicare or
951 Medicaid beneficiary.
952 (g)(h) Has more than one medical director contract in
953 effect at one time or more than one medical director contract
954 and one contract with a physician-specialist whose services are
955 mandated for the home health agency in order to qualify to
956 participate in a federal or state health care program at one
957 time.
958 (h)(i) Gives remuneration to a physician without a medical
959 director contract being in effect. The contract must:
960 1. Be in writing and signed by both parties;
961 2. Provide for remuneration that is at fair market value
962 for an hourly rate, which must be supported by invoices
963 submitted by the medical director describing the work performed,
964 the dates on which that work was performed, and the duration of
965 that work; and
966 3. Be for a term of at least 1 year.
967
968 The hourly rate specified in the contract may not be increased
969 during the term of the contract. The home health agency may not
970 execute a subsequent contract with that physician which has an
971 increased hourly rate and covers any portion of the term that
972 was in the original contract.
973 (i)(j) Gives remuneration to:
974 1. A physician, and the home health agency is in violation
975 of paragraph (g) (h) or paragraph (h) (i);
976 2. A member of the physician’s office staff; or
977 3. An immediate family member of the physician,
978
979 if the home health agency has received a patient referral in the
980 preceding 12 months from that physician or physician’s office
981 staff.
982 (j)(k) Fails to provide to the agency, upon request, copies
983 of all contracts with a medical director which were executed
984 within 5 years before the request.
985 (k)(l) Demonstrates a pattern of billing the Medicaid
986 program for services to Medicaid recipients which are medically
987 unnecessary as determined by a final order. A pattern may be
988 demonstrated by a showing of at least two such medically
989 unnecessary services within one Medicaid program integrity audit
990 period.
991
992 Nothing in paragraph (e) or paragraph (i) (j) shall be
993 interpreted as applying to or precluding any discount,
994 compensation, waiver of payment, or payment practice permitted
995 by 42 U.S.C. s. 1320a-7(b) or regulations adopted thereunder,
996 including 42 C.F.R. s. 1001.952 or s. 1395nn or regulations
997 adopted thereunder.
998 (7) Each home health agency shall submit to the agency,
999 within 15 days after the end of each calendar quarter, a written
1000 report that includes the following data as it existed on the
1001 last day of the quarter:
1002 (a) The number of insulin-dependent diabetic patients
1003 receiving insulin-injection services from the home health
1004 agency.
1005 (b) The number of patients receiving home health services
1006 from the home health agency who are also receiving hospice
1007 services.
1008 (c) The number of patients receiving home health services
1009 from the home health agency.
1010 (d) The names and license numbers of nurses whose primary
1011 job responsibility is to provide home health services to
1012 patients and who received remuneration from the home health
1013 agency in excess of $25,000 during the calendar quarter.
1014 (e) The number of physicians who were paid by the home
1015 health agency for professional services of any kind during the
1016 calendar quarter, the amount paid to each physician, and the
1017 number of hours each physician spent performing those services.
1018
1019 If the quarterly report is not received by the agency on or
1020 before the deadline, the agency shall impose a fine in the
1021 amount of $200 for each day that the report is late, which may
1022 not exceed $5,000 per quarter.
1023 Section 24. Section 400.484, Florida Statutes, is amended
1024 to read:
1025 400.484 Right of inspection; violations deficiencies;
1026 fines.—
1027 (1) In addition to the requirements of s. 408.811, the
1028 agency may make such inspections and investigations as are
1029 necessary in order to determine the state of compliance with
1030 this part, part II of chapter 408, and applicable rules.
1031 (2) The agency shall impose fines for various classes of
1032 violations deficiencies in accordance with the following
1033 schedule:
1034 (a) A class I violation is defined in s. 408.813 deficiency
1035 is any act, omission, or practice that results in a patient’s
1036 death, disablement, or permanent injury, or places a patient at
1037 imminent risk of death, disablement, or permanent injury. Upon
1038 finding a class I violation deficiency, the agency shall impose
1039 an administrative fine in the amount of $15,000 for each
1040 occurrence and each day that the violation deficiency exists.
1041 (b) A class II violation is defined in s. 408.813
1042 deficiency is any act, omission, or practice that has a direct
1043 adverse effect on the health, safety, or security of a patient.
1044 Upon finding a class II violation deficiency, the agency shall
1045 impose an administrative fine in the amount of $5,000 for each
1046 occurrence and each day that the violation deficiency exists.
1047 (c) A class III violation is defined in s. 408.813
1048 deficiency is any act, omission, or practice that has an
1049 indirect, adverse effect on the health, safety, or security of a
1050 patient. Upon finding an uncorrected or repeated class III
1051 violation deficiency, the agency shall impose an administrative
1052 fine not to exceed $1,000 for each occurrence and each day that
1053 the uncorrected or repeated violation deficiency exists.
1054 (d) A class IV violation is defined in s. 408.813
1055 deficiency is any act, omission, or practice related to required
1056 reports, forms, or documents which does not have the potential
1057 of negatively affecting patients. These violations are of a type
1058 that the agency determines do not threaten the health, safety,
1059 or security of patients. Upon finding an uncorrected or repeated
1060 class IV violation deficiency, the agency shall impose an
1061 administrative fine not to exceed $500 for each occurrence and
1062 each day that the uncorrected or repeated violation deficiency
1063 exists.
1064 (3) In addition to any other penalties imposed pursuant to
1065 this section or part, the agency may assess costs related to an
1066 investigation that results in a successful prosecution,
1067 excluding costs associated with an attorney’s time.
1068 Section 25. For the purpose of incorporating the amendment
1069 made by this act to section 400.509, Florida Statutes, in a
1070 reference thereto, paragraph (a) of subsection (6) of section
1071 400.506 is reenacted, present subsection (17) of that section is
1072 renumbered as subsection (18), and a new subsection (17) is
1073 added to that section, to read:
1074 400.506 Licensure of nurse registries; requirements;
1075 penalties.—
1076 (6)(a) A nurse registry may refer for contract in private
1077 residences registered nurses and licensed practical nurses
1078 registered and licensed under part I of chapter 464, certified
1079 nursing assistants certified under part II of chapter 464, home
1080 health aides who present documented proof of successful
1081 completion of the training required by rule of the agency, and
1082 companions or homemakers for the purposes of providing those
1083 services authorized under s. 400.509(1). A licensed nurse
1084 registry shall ensure that each certified nursing assistant
1085 referred for contract by the nurse registry and each home health
1086 aide referred for contract by the nurse registry is adequately
1087 trained to perform the tasks of a home health aide in the home
1088 setting. Each person referred by a nurse registry must provide
1089 current documentation that he or she is free from communicable
1090 diseases.
1091 (17) An administrator may manage only one nurse registry,
1092 except that an administrator may manage up to five registries if
1093 all five registries have identical controlling interests as
1094 defined in s. 408.803 and are located within one agency
1095 geographic service area or within an immediately contiguous
1096 county. An administrator shall designate, in writing, for each
1097 licensed entity, a qualified alternate administrator to serve
1098 during the administrator’s absence.
1099 Section 26. Subsection (1) of section 400.509, Florida
1100 Statutes, is amended to read:
1101 400.509 Registration of particular service providers exempt
1102 from licensure; certificate of registration; regulation of
1103 registrants.—
1104 (1) Any organization that provides companion services or
1105 homemaker services and does not provide a home health service to
1106 a person is exempt from licensure under this part. However, any
1107 organization that provides companion services or homemaker
1108 services must register with the agency. An organization under
1109 contract with the Agency for Persons with Disabilities which
1110 provides companion services only for persons with a
1111 developmental disability, as defined in s. 393.063, is exempt
1112 from registration.
1113 Section 27. Subsection (3) of section 400.601, Florida
1114 Statutes, is amended to read:
1115 400.601 Definitions.—As used in this part, the term:
1116 (3) “Hospice” means a centrally administered corporation or
1117 a limited liability company that provides providing a continuum
1118 of palliative and supportive care for the terminally ill patient
1119 and his or her family.
1120 Section 28. Paragraph (i) of subsection (1) and subsection
1121 (4) of section 400.606, Florida Statutes, are amended to read:
1122 400.606 License; application; renewal; conditional license
1123 or permit; certificate of need.—
1124 (1) In addition to the requirements of part II of chapter
1125 408, the initial application and change of ownership application
1126 must be accompanied by a plan for the delivery of home,
1127 residential, and homelike inpatient hospice services to
1128 terminally ill persons and their families. Such plan must
1129 contain, but need not be limited to:
1130 (i) The projected annual operating cost of the hospice.
1131
1132 If the applicant is an existing licensed health care provider,
1133 the application must be accompanied by a copy of the most recent
1134 profit-loss statement and, if applicable, the most recent
1135 licensure inspection report.
1136 (4) A freestanding hospice facility that is primarily
1137 engaged in providing inpatient and related services and that is
1138 not otherwise licensed as a health care facility shall be
1139 required to obtain a certificate of need. However, a
1140 freestanding hospice facility that has with six or fewer beds is
1141 shall not be required to comply with institutional standards
1142 such as, but not limited to, standards requiring sprinkler
1143 systems, emergency electrical systems, or special lavatory
1144 devices.
1145 Section 29. Section 400.915, Florida Statutes, is amended
1146 to read:
1147 400.915 Construction and renovation; requirements.—The
1148 requirements for the construction or renovation of a PPEC center
1149 shall comply with:
1150 (1) The provisions of chapter 553, which pertain to
1151 building construction standards, including plumbing, electrical
1152 code, glass, manufactured buildings, accessibility for the
1153 physically disabled;
1154 (2) The provisions of s. 633.022 and applicable rules
1155 pertaining to physical minimum standards for nonresidential
1156 child care physical facilities in rule 10M-12.003, Florida
1157 Administrative Code, Child Care Standards; and
1158 (3) The standards or rules adopted pursuant to this part
1159 and part II of chapter 408.
1160 Section 30. Section 400.931, Florida Statutes, is amended
1161 to read:
1162 400.931 Application for license; fee; provisional license;
1163 temporary permit.—
1164 (1) In addition to the requirements of part II of chapter
1165 408, the applicant must file with the application satisfactory
1166 proof that the home medical equipment provider is in compliance
1167 with this part and applicable rules, including:
1168 (a) A report, by category, of the equipment to be provided,
1169 indicating those offered either directly by the applicant or
1170 through contractual arrangements with existing providers.
1171 Categories of equipment include:
1172 1. Respiratory modalities.
1173 2. Ambulation aids.
1174 3. Mobility aids.
1175 4. Sickroom setup.
1176 5. Disposables.
1177 (b) A report, by category, of the services to be provided,
1178 indicating those offered either directly by the applicant or
1179 through contractual arrangements with existing providers.
1180 Categories of services include:
1181 1. Intake.
1182 2. Equipment selection.
1183 3. Delivery.
1184 4. Setup and installation.
1185 5. Patient training.
1186 6. Ongoing service and maintenance.
1187 7. Retrieval.
1188 (c) A listing of those with whom the applicant contracts,
1189 both the providers the applicant uses to provide equipment or
1190 services to its consumers and the providers for whom the
1191 applicant provides services or equipment.
1192 (2) An applicant for initial licensure, change of
1193 ownership, or license renewal to operate a licensed home medical
1194 equipment provider at a location outside the state must submit
1195 documentation of accreditation or an application for
1196 accreditation from an accrediting organization that is
1197 recognized by the agency. An applicant that has applied for
1198 accreditation must provide proof of accreditation that is not
1199 conditional or provisional within 120 days after the date the
1200 agency receives the application for licensure or the application
1201 shall be withdrawn from further consideration. Such
1202 accreditation must be maintained by the home medical equipment
1203 provider in order to maintain licensure. As an alternative to
1204 submitting proof of financial ability to operate as required in
1205 s. 408.810(8), the applicant may submit a $50,000 surety bond to
1206 the agency.
1207 (3) As specified in part II of chapter 408, the home
1208 medical equipment provider must also obtain and maintain
1209 professional and commercial liability insurance. Proof of
1210 liability insurance, as defined in s. 624.605, must be submitted
1211 with the application. The agency shall set the required amounts
1212 of liability insurance by rule, but the required amount must not
1213 be less than $250,000 per claim. In the case of contracted
1214 services, it is required that the contractor have liability
1215 insurance not less than $250,000 per claim.
1216 (4) When a change of the general manager of a home medical
1217 equipment provider occurs, the licensee must notify the agency
1218 of the change within 45 days.
1219 (5) In accordance with s. 408.805, an applicant or a
1220 licensee shall pay a fee for each license application submitted
1221 under this part, part II of chapter 408, and applicable rules.
1222 The amount of the fee shall be established by rule and may not
1223 exceed $300 per biennium. The agency shall set the fees in an
1224 amount that is sufficient to cover its costs in carrying out its
1225 responsibilities under this part. However, state, county, or
1226 municipal governments applying for licenses under this part are
1227 exempt from the payment of license fees.
1228 (6) An applicant for initial licensure, renewal, or change
1229 of ownership shall also pay an inspection fee not to exceed
1230 $400, which shall be paid by all applicants except those not
1231 subject to licensure inspection by the agency as described in s.
1232 400.933.
1233 Section 31. Section 400.967, Florida Statutes, is amended
1234 to read:
1235 400.967 Rules and classification of violations
1236 deficiencies.—
1237 (1) It is the intent of the Legislature that rules adopted
1238 and enforced under this part and part II of chapter 408 include
1239 criteria by which a reasonable and consistent quality of
1240 resident care may be ensured, the results of such resident care
1241 can be demonstrated, and safe and sanitary facilities can be
1242 provided.
1243 (2) Pursuant to the intention of the Legislature, the
1244 agency, in consultation with the Agency for Persons with
1245 Disabilities and the Department of Elderly Affairs, shall adopt
1246 and enforce rules to administer this part and part II of chapter
1247 408, which shall include reasonable and fair criteria governing:
1248 (a) The location and construction of the facility;
1249 including fire and life safety, plumbing, heating, cooling,
1250 lighting, ventilation, and other housing conditions that ensure
1251 the health, safety, and comfort of residents. The agency shall
1252 establish standards for facilities and equipment to increase the
1253 extent to which new facilities and a new wing or floor added to
1254 an existing facility after July 1, 2000, are structurally
1255 capable of serving as shelters only for residents, staff, and
1256 families of residents and staff, and equipped to be self
1257 supporting during and immediately following disasters. The
1258 agency shall update or revise the criteria as the need arises.
1259 All facilities must comply with those lifesafety code
1260 requirements and building code standards applicable at the time
1261 of approval of their construction plans. The agency may require
1262 alterations to a building if it determines that an existing
1263 condition constitutes a distinct hazard to life, health, or
1264 safety. The agency shall adopt fair and reasonable rules setting
1265 forth conditions under which existing facilities undergoing
1266 additions, alterations, conversions, renovations, or repairs are
1267 required to comply with the most recent updated or revised
1268 standards.
1269 (b) The number and qualifications of all personnel,
1270 including management, medical nursing, and other personnel,
1271 having responsibility for any part of the care given to
1272 residents.
1273 (c) All sanitary conditions within the facility and its
1274 surroundings, including water supply, sewage disposal, food
1275 handling, and general hygiene, which will ensure the health and
1276 comfort of residents.
1277 (d) The equipment essential to the health and welfare of
1278 the residents.
1279 (e) A uniform accounting system.
1280 (f) The care, treatment, and maintenance of residents and
1281 measurement of the quality and adequacy thereof.
1282 (g) The preparation and annual update of a comprehensive
1283 emergency management plan. The agency shall adopt rules
1284 establishing minimum criteria for the plan after consultation
1285 with the Division of Emergency Management. At a minimum, the
1286 rules must provide for plan components that address emergency
1287 evacuation transportation; adequate sheltering arrangements;
1288 postdisaster activities, including emergency power, food, and
1289 water; postdisaster transportation; supplies; staffing;
1290 emergency equipment; individual identification of residents and
1291 transfer of records; and responding to family inquiries. The
1292 comprehensive emergency management plan is subject to review and
1293 approval by the local emergency management agency. During its
1294 review, the local emergency management agency shall ensure that
1295 the following agencies, at a minimum, are given the opportunity
1296 to review the plan: the Department of Elderly Affairs, the
1297 Agency for Persons with Disabilities, the Agency for Health Care
1298 Administration, and the Division of Emergency Management. Also,
1299 appropriate volunteer organizations must be given the
1300 opportunity to review the plan. The local emergency management
1301 agency shall complete its review within 60 days and either
1302 approve the plan or advise the facility of necessary revisions.
1303 (h) The use of restraint and seclusion. Such rules must be
1304 consistent with recognized best practices; prohibit inherently
1305 dangerous restraint or seclusion procedures; establish
1306 limitations on the use and duration of restraint and seclusion;
1307 establish measures to ensure the safety of clients and staff
1308 during an incident of restraint or seclusion; establish
1309 procedures for staff to follow before, during, and after
1310 incidents of restraint or seclusion, including individualized
1311 plans for the use of restraints or seclusion in emergency
1312 situations; establish professional qualifications of and
1313 training for staff who may order or be engaged in the use of
1314 restraint or seclusion; establish requirements for facility data
1315 collection and reporting relating to the use of restraint and
1316 seclusion; and establish procedures relating to the
1317 documentation of the use of restraint or seclusion in the
1318 client’s facility or program record.
1319 (3) The agency shall adopt rules to provide that, when the
1320 criteria established under this part and part II of chapter 408
1321 are not met, such violations deficiencies shall be classified
1322 according to the nature of the violation deficiency. The agency
1323 shall indicate the classification on the face of the notice of
1324 violation deficiencies as follows:
1325 (a) A class I violation is defined in s. 408.813
1326 deficiencies are those which the agency determines present an
1327 imminent danger to the residents or guests of the facility or a
1328 substantial probability that death or serious physical harm
1329 would result therefrom. The condition or practice constituting a
1330 class I violation must be abated or eliminated immediately,
1331 unless a fixed period of time, as determined by the agency, is
1332 required for correction. A class I violation deficiency is
1333 subject to a civil penalty in an amount not less than $5,000 and
1334 not exceeding $10,000 for each violation deficiency. A fine may
1335 be levied notwithstanding the correction of the violation
1336 deficiency.
1337 (b) A class II violation is defined in s. 408.813
1338 deficiencies are those which the agency determines have a direct
1339 or immediate relationship to the health, safety, or security of
1340 the facility residents, other than class I deficiencies. A class
1341 II violation deficiency is subject to a civil penalty in an
1342 amount not less than $1,000 and not exceeding $5,000 for each
1343 violation deficiency. A citation for a class II violation
1344 deficiency shall specify the time within which the violation
1345 deficiency must be corrected. If a class II violation deficiency
1346 is corrected within the time specified, no civil penalty shall
1347 be imposed, unless it is a repeated offense.
1348 (c) A class III violation is defined in s. 408.813
1349 deficiencies are those which the agency determines to have an
1350 indirect or potential relationship to the health, safety, or
1351 security of the facility residents, other than class I or class
1352 II deficiencies. A class III violation deficiency is subject to
1353 a civil penalty of not less than $500 and not exceeding $1,000
1354 for each violation deficiency. A citation for a class III
1355 violation deficiency shall specify the time within which the
1356 violation deficiency must be corrected. If a class III violation
1357 deficiency is corrected within the time specified, no civil
1358 penalty shall be imposed, unless it is a repeated offense.
1359 (d) A class IV violation is defined in s. 408.813. Upon
1360 finding an uncorrected or repeated class IV violation, the
1361 agency shall impose an administrative fine not to exceed $500
1362 for each occurrence and each day that the uncorrected or
1363 repeated violation exists.
1364 (4) The agency shall approve or disapprove the plans and
1365 specifications within 60 days after receipt of the final plans
1366 and specifications. The agency may be granted one 15-day
1367 extension for the review period, if the secretary of the agency
1368 so approves. If the agency fails to act within the specified
1369 time, it is deemed to have approved the plans and
1370 specifications. When the agency disapproves plans and
1371 specifications, it must set forth in writing the reasons for
1372 disapproval. Conferences and consultations may be provided as
1373 necessary.
1374 (5) The agency may charge an initial fee of $2,000 for
1375 review of plans and construction on all projects, no part of
1376 which is refundable. The agency may also collect a fee, not to
1377 exceed 1 percent of the estimated construction cost or the
1378 actual cost of review, whichever is less, for the portion of the
1379 review which encompasses initial review through the initial
1380 revised construction document review. The agency may collect its
1381 actual costs on all subsequent portions of the review and
1382 construction inspections. Initial fee payment must accompany the
1383 initial submission of plans and specifications. Any subsequent
1384 payment that is due is payable upon receipt of the invoice from
1385 the agency. Notwithstanding any other provision of law, all
1386 money received by the agency under this section shall be deemed
1387 to be trust funds, to be held and applied solely for the
1388 operations required under this section.
1389 Section 32. Subsections (4) and (7) of section 400.9905,
1390 Florida Statutes, are amended to read:
1391 400.9905 Definitions.—
1392 (4) “Clinic” means an entity at which health care services
1393 are provided to individuals and which tenders charges for
1394 reimbursement for such services, including a mobile clinic and a
1395 portable health service or equipment provider. For purposes of
1396 this part, the term does not include and the licensure
1397 requirements of this part do not apply to:
1398 (a) Entities licensed or registered by the state under
1399 chapter 395; or entities licensed or registered by the state and
1400 providing only health care services within the scope of services
1401 authorized under their respective licenses granted under ss.
1402 383.30-383.335, chapter 390, chapter 394, chapter 397, this
1403 chapter except part X, chapter 429, chapter 463, chapter 465,
1404 chapter 466, chapter 478, part I of chapter 483, chapter 484, or
1405 chapter 651; end-stage renal disease providers authorized under
1406 42 C.F.R. part 405, subpart U; or providers certified under 42
1407 C.F.R. part 485, subpart B or subpart H; or any entity that
1408 provides neonatal or pediatric hospital-based health care
1409 services or other health care services by licensed practitioners
1410 solely within a hospital licensed under chapter 395.
1411 (b) Entities that own, directly or indirectly, entities
1412 licensed or registered by the state pursuant to chapter 395; or
1413 entities that own, directly or indirectly, entities licensed or
1414 registered by the state and providing only health care services
1415 within the scope of services authorized pursuant to their
1416 respective licenses granted under ss. 383.30-383.335, chapter
1417 390, chapter 394, chapter 397, this chapter except part X,
1418 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
1419 part I of chapter 483, chapter 484, chapter 651; end-stage renal
1420 disease providers authorized under 42 C.F.R. part 405, subpart
1421 U; or providers certified under 42 C.F.R. part 485, subpart B or
1422 subpart H; or any entity that provides neonatal or pediatric
1423 hospital-based health care services by licensed practitioners
1424 solely within a hospital licensed under chapter 395.
1425 (c) Entities that are owned, directly or indirectly, by an
1426 entity licensed or registered by the state pursuant to chapter
1427 395; or entities that are owned, directly or indirectly, by an
1428 entity licensed or registered by the state and providing only
1429 health care services within the scope of services authorized
1430 pursuant to their respective licenses granted under ss. 383.30
1431 383.335, chapter 390, chapter 394, chapter 397, this chapter
1432 except part X, chapter 429, chapter 463, chapter 465, chapter
1433 466, chapter 478, part I of chapter 483, chapter 484, or chapter
1434 651; end-stage renal disease providers authorized under 42
1435 C.F.R. part 405, subpart U; or providers certified under 42
1436 C.F.R. part 485, subpart B or subpart H; or any entity that
1437 provides neonatal or pediatric hospital-based health care
1438 services by licensed practitioners solely within a hospital
1439 under chapter 395.
1440 (d) Entities that are under common ownership, directly or
1441 indirectly, with an entity licensed or registered by the state
1442 pursuant to chapter 395; or entities that are under common
1443 ownership, directly or indirectly, with an entity licensed or
1444 registered by the state and providing only health care services
1445 within the scope of services authorized pursuant to their
1446 respective licenses granted under ss. 383.30-383.335, chapter
1447 390, chapter 394, chapter 397, this chapter except part X,
1448 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
1449 part I of chapter 483, chapter 484, or chapter 651; end-stage
1450 renal disease providers authorized under 42 C.F.R. part 405,
1451 subpart U; or providers certified under 42 C.F.R. part 485,
1452 subpart B or subpart H; or any entity that provides neonatal or
1453 pediatric hospital-based health care services by licensed
1454 practitioners solely within a hospital licensed under chapter
1455 395.
1456 (e) An entity that is exempt from federal taxation under 26
1457 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan
1458 under 26 U.S.C. s. 409 that has a board of trustees not less
1459 than two-thirds of which are Florida-licensed health care
1460 practitioners and provides only physical therapy services under
1461 physician orders, any community college or university clinic,
1462 and any entity owned or operated by the federal or state
1463 government, including agencies, subdivisions, or municipalities
1464 thereof.
1465 (f) A sole proprietorship, group practice, partnership, or
1466 corporation that provides health care services by physicians
1467 covered by s. 627.419, that is directly supervised by one or
1468 more of such physicians, and that is wholly owned by one or more
1469 of those physicians or by a physician and the spouse, parent,
1470 child, or sibling of that physician.
1471 (g) A sole proprietorship, group practice, partnership, or
1472 corporation that provides health care services by licensed
1473 health care practitioners under chapter 457, chapter 458,
1474 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
1475 chapter 466, chapter 467, chapter 480, chapter 484, chapter 486,
1476 chapter 490, chapter 491, or part I, part III, part X, part
1477 XIII, or part XIV of chapter 468, or s. 464.012, which are
1478 wholly owned by one or more licensed health care practitioners,
1479 or the licensed health care practitioners set forth in this
1480 paragraph and the spouse, parent, child, or sibling of a
1481 licensed health care practitioner, so long as one of the owners
1482 who is a licensed health care practitioner is supervising the
1483 business activities and is legally responsible for the entity’s
1484 compliance with all federal and state laws. However, a health
1485 care practitioner may not supervise services beyond the scope of
1486 the practitioner’s license, except that, for the purposes of
1487 this part, a clinic owned by a licensee in s. 456.053(3)(b) that
1488 provides only services authorized pursuant to s. 456.053(3)(b)
1489 may be supervised by a licensee specified in s. 456.053(3)(b).
1490 (h) Clinical facilities affiliated with an accredited
1491 medical school at which training is provided for medical
1492 students, residents, or fellows.
1493 (i) Entities that provide only oncology or radiation
1494 therapy services by physicians licensed under chapter 458 or
1495 chapter 459 or entities that provide oncology or radiation
1496 therapy services by physicians licensed under chapter 458 or
1497 chapter 459 which are owned by a corporation whose shares are
1498 publicly traded on a recognized stock exchange.
1499 (j) Clinical facilities affiliated with a college of
1500 chiropractic accredited by the Council on Chiropractic Education
1501 at which training is provided for chiropractic students.
1502 (k) Entities that provide licensed practitioners to staff
1503 emergency departments or to deliver anesthesia services in
1504 facilities licensed under chapter 395 and that derive at least
1505 90 percent of their gross annual revenues from the provision of
1506 such services. Entities claiming an exemption from licensure
1507 under this paragraph must provide documentation demonstrating
1508 compliance.
1509 (l) Orthotic, or prosthetic, pediatric cardiology, or
1510 perinatology clinical facilities or anesthesia clinical
1511 facilities that are not otherwise exempt under paragraph (a) or
1512 paragraph (k) and that are a publicly traded corporation or that
1513 are wholly owned, directly or indirectly, by a publicly traded
1514 corporation. As used in this paragraph, a publicly traded
1515 corporation is a corporation that issues securities traded on an
1516 exchange registered with the United States Securities and
1517 Exchange Commission as a national securities exchange.
1518 (m) Entities that are owned or controlled, directly or
1519 indirectly, by a publicly traded entity with $100 million or
1520 more, in the aggregate, in total annual revenues derived from
1521 providing health care services by licensed health care
1522 practitioners that are employed or contracted by an entity
1523 described in this paragraph.
1524 (n) Entities that are owned by a corporation that has $250
1525 million or more in total annual sales of health care services
1526 provided by licensed health care practitioners if one or more of
1527 the owners of the entity is a health care practitioner who is
1528 licensed in this state, is responsible for supervising the
1529 business activities of the entity, and is legally responsible
1530 for the entity’s compliance with state law for purposes of this
1531 section.
1532 (o) Entities that employ 50 or more health care
1533 practitioners who are licensed under chapter 458 or chapter 459
1534 if the billing for medical services is under a single corporate
1535 tax identification number. The application for exemption under
1536 this paragraph must contain information that includes the name,
1537 residence address, business address, and telephone number of the
1538 entity that owns the practice; a complete list of the names and
1539 contact information of all the officers and directors of the
1540 entity; the name, residence address, business address, and
1541 medical license number of each health care practitioner who is
1542 licensed to practice in this state and employed by the entity;
1543 the corporate tax identification number of the entity seeking an
1544 exemption; a listing of health care services to be provided by
1545 the entity at the health care clinics owned or operated by the
1546 entity; and a certified statement prepared by an independent
1547 certified public accountant which states that the entity and the
1548 health care clinics owned or operated by the entity have not
1549 received payment for health care services under insurance
1550 coverage for personal injury protection for the preceding year.
1551 If the agency determines that an entity that is exempt under
1552 this paragraph has received payments for medical services for
1553 insurance coverage for personal injury protection, the agency
1554 may deny or revoke the exemption from licensure under this
1555 paragraph.
1556 (7) “Portable health service or equipment provider” means
1557 an entity that contracts with or employs persons to provide
1558 portable health services at or equipment to multiple locations
1559 performing treatment or diagnostic testing of individuals, that
1560 bills third-party payors for those services, and that otherwise
1561 meets the definition of a clinic in subsection (4).
1562 Section 33. Paragraph (b) of subsection (1) and subsection
1563 (4) of section 400.991, Florida Statutes, are amended to read:
1564 400.991 License requirements; background screenings;
1565 prohibitions.—
1566 (1)
1567 (b) Each mobile clinic must obtain a separate health care
1568 clinic license and must provide to the agency, at least
1569 quarterly, its projected street location to enable the agency to
1570 locate and inspect such clinic. A portable health service or
1571 equipment provider must obtain a health care clinic license for
1572 a single administrative office and is not required to submit
1573 quarterly projected street locations.
1574 (4) In addition to the requirements of part II of chapter
1575 408, the applicant must file with the application satisfactory
1576 proof that the clinic is in compliance with this part and
1577 applicable rules, including:
1578 (a) A listing of services to be provided either directly by
1579 the applicant or through contractual arrangements with existing
1580 providers;
1581 (b) The number and discipline of each professional staff
1582 member to be employed; and
1583 (c) Proof of financial ability to operate as required under
1584 ss. s. 408.810(8) and 408.8065. As an alternative to submitting
1585 proof of financial ability to operate as required under s.
1586 408.810(8), the applicant may file a surety bond of at least
1587 $500,000 which guarantees that the clinic will act in full
1588 conformity with all legal requirements for operating a clinic,
1589 payable to the agency. The agency may adopt rules to specify
1590 related requirements for such surety bond.
1591 Section 34. Paragraph (a) of subsection (2) of section
1592 408.033, Florida Statutes, is amended to read:
1593 408.033 Local and state health planning.—
1594 (2) FUNDING.—
1595 (a) The Legislature intends that the cost of local health
1596 councils be borne by assessments on selected health care
1597 facilities subject to facility licensure by the Agency for
1598 Health Care Administration, including abortion clinics, assisted
1599 living facilities, ambulatory surgical centers, birthing
1600 centers, clinical laboratories except community nonprofit blood
1601 banks and clinical laboratories operated by practitioners for
1602 exclusive use regulated under s. 483.035, home health agencies,
1603 hospices, hospitals, intermediate care facilities for the
1604 developmentally disabled, nursing homes, health care clinics,
1605 and multiphasic testing centers and by assessments on
1606 organizations subject to certification by the agency pursuant to
1607 chapter 641, part III, including health maintenance
1608 organizations and prepaid health clinics. Fees assessed may be
1609 collected prospectively at the time of licensure renewal and
1610 prorated for the licensure period.
1611 Section 35. Subsection (2) of section 408.034, Florida
1612 Statutes, is amended to read:
1613 408.034 Duties and responsibilities of agency; rules.—
1614 (2) In the exercise of its authority to issue licenses to
1615 health care facilities and health service providers, as provided
1616 under chapters 393 and 395 and parts II, and IV, and VIII of
1617 chapter 400, the agency may not issue a license to any health
1618 care facility or health service provider that fails to receive a
1619 certificate of need or an exemption for the licensed facility or
1620 service.
1621 Section 36. Paragraph (d) of subsection (1) of section
1622 408.036, Florida Statutes, is amended to read:
1623 408.036 Projects subject to review; exemptions.—
1624 (1) APPLICABILITY.—Unless exempt under subsection (3), all
1625 health-care-related projects, as described in paragraphs (a)
1626 (g), are subject to review and must file an application for a
1627 certificate of need with the agency. The agency is exclusively
1628 responsible for determining whether a health-care-related
1629 project is subject to review under ss. 408.031-408.045.
1630 (d) The establishment of a hospice or hospice inpatient
1631 facility, except as provided in s. 408.043.
1632 Section 37. Paragraph (c) of subsection (1) of section
1633 408.037, Florida Statutes, is amended to read:
1634 408.037 Application content.—
1635 (1) Except as provided in subsection (2) for a general
1636 hospital, an application for a certificate of need must contain:
1637 (c) An audited financial statement of the applicant or the
1638 applicant’s parent corporation if audited financial statements
1639 of the applicant do not exist. In an application submitted by an
1640 existing health care facility, health maintenance organization,
1641 or hospice, financial condition documentation must include, but
1642 need not be limited to, a balance sheet and a profit-and-loss
1643 statement of the 2 previous fiscal years’ operation.
1644 Section 38. Subsection (2) of section 408.043, Florida
1645 Statutes, is amended to read:
1646 408.043 Special provisions.—
1647 (2) HOSPICES.—When an application is made for a certificate
1648 of need to establish or to expand a hospice, the need for such
1649 hospice shall be determined on the basis of the need for and
1650 availability of hospice services in the community. The formula
1651 on which the certificate of need is based shall discourage
1652 regional monopolies and promote competition. The inpatient
1653 hospice care component of a hospice which is a freestanding
1654 facility, or a part of a facility, which is primarily engaged in
1655 providing inpatient care and related services and is not
1656 licensed as a health care facility shall also be required to
1657 obtain a certificate of need. Provision of hospice care by any
1658 current provider of health care is a significant change in
1659 service and therefore requires a certificate of need for such
1660 services.
1661 Section 39. Paragraph (a) of subsection (1) of section
1662 408.061, Florida Statutes, is amended to read:
1663 408.061 Data collection; uniform systems of financial
1664 reporting; information relating to physician charges;
1665 confidential information; immunity.—
1666 (1) The agency shall require the submission by health care
1667 facilities, health care providers, and health insurers of data
1668 necessary to carry out the agency’s duties. Specifications for
1669 data to be collected under this section shall be developed by
1670 the agency with the assistance of technical advisory panels
1671 including representatives of affected entities, consumers,
1672 purchasers, and such other interested parties as may be
1673 determined by the agency.
1674 (a) Data submitted by health care facilities, including the
1675 facilities as defined in chapter 395, shall include, but are not
1676 limited to: case-mix data, patient admission and discharge data,
1677 hospital emergency department data which shall include the
1678 number of patients treated in the emergency department of a
1679 licensed hospital reported by patient acuity level, data on
1680 hospital-acquired infections as specified by rule, data on
1681 complications as specified by rule, data on readmissions as
1682 specified by rule, with patient and provider-specific
1683 identifiers included, actual charge data by diagnostic groups,
1684 financial data, accounting data, operating expenses, expenses
1685 incurred for rendering services to patients who cannot or do not
1686 pay, interest charges, depreciation expenses based on the
1687 expected useful life of the property and equipment involved, and
1688 demographic data. The agency shall adopt nationally recognized
1689 risk adjustment methodologies or software consistent with the
1690 standards of the Agency for Healthcare Research and Quality and
1691 as selected by the agency for all data submitted as required by
1692 this section. Data may be obtained from documents such as, but
1693 not limited to: leases, contracts, debt instruments, itemized
1694 patient bills, medical record abstracts, and related diagnostic
1695 information. Reported data elements shall be reported
1696 electronically and in accordance with rule 59E-7.012, Florida
1697 Administrative Code. Data submitted shall be certified by the
1698 chief executive officer or an appropriate and duly authorized
1699 representative or employee of the licensed facility that the
1700 information submitted is true and accurate.
1701 Section 40. Subsection (43) of section 408.07, Florida
1702 Statutes, is amended to read:
1703 408.07 Definitions.—As used in this chapter, with the
1704 exception of ss. 408.031-408.045, the term:
1705 (43) “Rural hospital” means an acute care hospital licensed
1706 under chapter 395, having 100 or fewer licensed beds and an
1707 emergency room, and which is:
1708 (a) The sole provider within a county with a population
1709 density of no greater than 100 persons per square mile;
1710 (b) An acute care hospital, in a county with a population
1711 density of no greater than 100 persons per square mile, which is
1712 at least 30 minutes of travel time, on normally traveled roads
1713 under normal traffic conditions, from another acute care
1714 hospital within the same county;
1715 (c) A hospital supported by a tax district or subdistrict
1716 whose boundaries encompass a population of 100 persons or fewer
1717 per square mile;
1718 (d) A hospital with a service area that has a population of
1719 100 persons or fewer per square mile. As used in this paragraph,
1720 the term “service area” means the fewest number of zip codes
1721 that account for 75 percent of the hospital’s discharges for the
1722 most recent 5-year period, based on information available from
1723 the hospital inpatient discharge database in the Florida Center
1724 for Health Information and Policy Analysis at the Agency for
1725 Health Care Administration; or
1726 (e) A critical access hospital.
1727
1728 Population densities used in this subsection must be based upon
1729 the most recently completed United States census. A hospital
1730 that received funds under s. 409.9116 for a quarter beginning no
1731 later than July 1, 2002, is deemed to have been and shall
1732 continue to be a rural hospital from that date through June 30,
1733 2015, if the hospital continues to have 100 or fewer licensed
1734 beds and an emergency room, or meets the criteria of s.
1735 395.602(2)(e)4. An acute care hospital that has not previously
1736 been designated as a rural hospital and that meets the criteria
1737 of this subsection shall be granted such designation upon
1738 application, including supporting documentation, to the Agency
1739 for Health Care Administration.
1740 Section 41. Section 408.10, Florida Statutes, is amended to
1741 read:
1742 408.10 Consumer complaints.—The agency shall:
1743 (1) publish and make available to the public a toll-free
1744 telephone number for the purpose of handling consumer complaints
1745 and shall serve as a liaison between consumer entities and other
1746 private entities and governmental entities for the disposition
1747 of problems identified by consumers of health care.
1748 (2) Be empowered to investigate consumer complaints
1749 relating to problems with health care facilities’ billing
1750 practices and issue reports to be made public in any cases where
1751 the agency determines the health care facility has engaged in
1752 billing practices which are unreasonable and unfair to the
1753 consumer.
1754 Section 42. Effective May 1, 2012, subsection (15) is added
1755 to section 408.7056, Florida Statutes, to read:
1756 408.7056 Subscriber Assistance Program.—
1757 (15) This section applies only to prepaid health clinics
1758 certified under chapter 641, Florida Healthy Kids health plans,
1759 and health plans that meet the requirements of 45 C.F.R.
1760 147.140.
1761 Section 43. Subsection (11) of section 408.802, Florida
1762 Statutes, is repealed.
1763 Section 44. Subsection (3) is added to section 408.804,
1764 Florida Statutes, to read:
1765 408.804 License required; display.—
1766 (3) Any person who knowingly alters, defaces, or falsifies
1767 a license certificate issued by the agency, or causes or
1768 procures any person to commit such an offense, commits a
1769 misdemeanor of the second degree, punishable as provided in s.
1770 775.082 or s. 775.083. Any licensee or provider who displays an
1771 altered, defaced, or falsified license certificate is subject to
1772 the penalties set forth in s. 408.815 and an administrative fine
1773 of $1,000 for each day of illegal display.
1774 Section 45. Paragraph (d) of subsection (2) of section
1775 408.806, Florida Statutes, is amended, and paragraph (e) is
1776 added to that subsection, to read:
1777 408.806 License application process.—
1778 (2)
1779 (d) The agency shall notify the licensee by mail or
1780 electronically at least 90 days before the expiration of a
1781 license that a renewal license is necessary to continue
1782 operation. The licensee’s failure to timely file submit a
1783 renewal application and license application fee with the agency
1784 shall result in a $50 per day late fee charged to the licensee
1785 by the agency; however, the aggregate amount of the late fee may
1786 not exceed 50 percent of the licensure fee or $500, whichever is
1787 less. The agency shall provide a courtesy notice to the licensee
1788 by United States mail, electronically, or by any other manner at
1789 its address of record or mailing address, if provided, at least
1790 90 days before the expiration of a license. This courtesy notice
1791 must inform the licensee of the expiration of the license. If
1792 the agency does not provide the courtesy notice or the licensee
1793 does not receive the courtesy notice, the licensee continues to
1794 be legally obligated to timely file the renewal application and
1795 license application fee with the agency and is not excused from
1796 the payment of a late fee. If an application is received after
1797 the required filing date and exhibits a hand-canceled postmark
1798 obtained from a United States post office dated on or before the
1799 required filing date, no fine will be levied.
1800 (e) The applicant must pay the late fee before a late
1801 application is considered complete and failure to pay the late
1802 fee is considered an omission from the application for licensure
1803 pursuant to paragraph (3)(b).
1804 Section 46. Paragraph (b) of subsection (1) of section
1805 408.8065, Florida Statutes, is amended to read:
1806 408.8065 Additional licensure requirements for home health
1807 agencies, home medical equipment providers, and health care
1808 clinics.—
1809 (1) An applicant for initial licensure, or initial
1810 licensure due to a change of ownership, as a home health agency,
1811 home medical equipment provider, or health care clinic shall:
1812 (b) Submit projected pro forma financial statements,
1813 including a balance sheet, income and expense statement, and a
1814 statement of cash flows for the first 2 years of operation which
1815 provide evidence that the applicant has sufficient assets,
1816 credit, and projected revenues to cover liabilities and
1817 expenses.
1818
1819 All documents required under this subsection must be prepared in
1820 accordance with generally accepted accounting principles and may
1821 be in a compilation form. The financial statements must be
1822 signed by a certified public accountant.
1823 Section 47. Section 408.809, Florida Statutes, is amended
1824 to read:
1825 408.809 Background screening; prohibited offenses.—
1826 (1) Level 2 background screening pursuant to chapter 435
1827 must be conducted through the agency on each of the following
1828 persons, who are considered employees for the purposes of
1829 conducting screening under chapter 435:
1830 (a) The licensee, if an individual.
1831 (b) The administrator or a similarly titled person who is
1832 responsible for the day-to-day operation of the provider.
1833 (c) The financial officer or similarly titled individual
1834 who is responsible for the financial operation of the licensee
1835 or provider.
1836 (d) Any person who is a controlling interest if the agency
1837 has reason to believe that such person has been convicted of any
1838 offense prohibited by s. 435.04. For each controlling interest
1839 who has been convicted of any such offense, the licensee shall
1840 submit to the agency a description and explanation of the
1841 conviction at the time of license application.
1842 (e) Any person, as required by authorizing statutes,
1843 seeking employment with a licensee or provider who is expected
1844 to, or whose responsibilities may require him or her to, provide
1845 personal care or services directly to clients or have access to
1846 client funds, personal property, or living areas; and any
1847 person, as required by authorizing statutes, contracting with a
1848 licensee or provider whose responsibilities require him or her
1849 to provide personal care or personal services directly to
1850 clients. Evidence of contractor screening may be retained by the
1851 contractor’s employer or the licensee.
1852 (2) Every 5 years following his or her licensure,
1853 employment, or entry into a contract in a capacity that under
1854 subsection (1) would require level 2 background screening under
1855 chapter 435, each such person must submit to level 2 background
1856 rescreening as a condition of retaining such license or
1857 continuing in such employment or contractual status. For any
1858 such rescreening, the agency shall request the Department of Law
1859 Enforcement to forward the person’s fingerprints to the Federal
1860 Bureau of Investigation for a national criminal history record
1861 check. If the fingerprints of such a person are not retained by
1862 the Department of Law Enforcement under s. 943.05(2)(g), the
1863 person must file a complete set of fingerprints with the agency
1864 and the agency shall forward the fingerprints to the Department
1865 of Law Enforcement for state processing, and the Department of
1866 Law Enforcement shall forward the fingerprints to the Federal
1867 Bureau of Investigation for a national criminal history record
1868 check. The fingerprints may be retained by the Department of Law
1869 Enforcement under s. 943.05(2)(g). The cost of the state and
1870 national criminal history records checks required by level 2
1871 screening may be borne by the licensee or the person
1872 fingerprinted. Proof of compliance with level 2 screening
1873 standards submitted within the previous 5 years to meet any
1874 provider or professional licensure requirements of the Agency,
1875 the Department of Health, the Agency for Persons with
1876 Disabilities, the Department of Children and Family Services,
1877 the Department of Elderly Affairs, or the Department of
1878 Financial Services for an applicant for a certificate of
1879 authority or provisional certificate of authority to operate a
1880 continuing care retirement community under chapter 651 satisfies
1881 the requirements of this section if the screening standards and
1882 disqualifying offenses are equivalent to those specified in s.
1883 453.04 and this section, and the person subject to screening has
1884 not been unemployed for more than 90 days and such proof is
1885 accompanied, under penalty of perjury, by an affidavit of
1886 compliance with the provisions of chapter 435 and this section
1887 using forms provided by the agency.
1888 (3) All fingerprints must be provided in electronic format.
1889 Screening results shall be reviewed by the agency with respect
1890 to the offenses specified in s. 435.04 and this section, and the
1891 qualifying or disqualifying status of the person named in the
1892 request shall be maintained in a database. The qualifying or
1893 disqualifying status of the person named in the request shall be
1894 posted on a secure website for retrieval by the licensee or
1895 designated agent on the licensee’s behalf.
1896 (4) In addition to the offenses listed in s. 435.04, all
1897 persons required to undergo background screening pursuant to
1898 this part or authorizing statutes must not have an arrest
1899 awaiting final disposition for, must not have been found guilty
1900 of, regardless of adjudication, or entered a plea of nolo
1901 contendere or guilty to, and must not have been adjudicated
1902 delinquent and the record not have been sealed or expunged for
1903 any of the following offenses or any similar offense of another
1904 jurisdiction:
1905 (a) Any authorizing statutes, if the offense was a felony.
1906 (b) This chapter, if the offense was a felony.
1907 (c) Section 409.920, relating to Medicaid provider fraud.
1908 (d) Section 409.9201, relating to Medicaid fraud.
1909 (e) Section 741.28, relating to domestic violence.
1910 (f) Section 817.034, relating to fraudulent acts through
1911 mail, wire, radio, electromagnetic, photoelectronic, or
1912 photooptical systems.
1913 (g) Section 817.234, relating to false and fraudulent
1914 insurance claims.
1915 (h) Section 817.505, relating to patient brokering.
1916 (i) Section 817.568, relating to criminal use of personal
1917 identification information.
1918 (j) Section 817.60, relating to obtaining a credit card
1919 through fraudulent means.
1920 (k) Section 817.61, relating to fraudulent use of credit
1921 cards, if the offense was a felony.
1922 (l) Section 831.01, relating to forgery.
1923 (m) Section 831.02, relating to uttering forged
1924 instruments.
1925 (n) Section 831.07, relating to forging bank bills, checks,
1926 drafts, or promissory notes.
1927 (o) Section 831.09, relating to uttering forged bank bills,
1928 checks, drafts, or promissory notes.
1929 (p) Section 831.30, relating to fraud in obtaining
1930 medicinal drugs.
1931 (q) Section 831.31, relating to the sale, manufacture,
1932 delivery, or possession with the intent to sell, manufacture, or
1933 deliver any counterfeit controlled substance, if the offense was
1934 a felony.
1935 (5) A person who serves as a controlling interest of, is
1936 employed by, or contracts with a licensee on July 31, 2010, who
1937 has been screened and qualified according to standards specified
1938 in s. 435.03 or s. 435.04 must be rescreened by July 31, 2015,
1939 in accordance with the schedule provided in paragraphs (a)-(c).
1940 The agency may adopt rules to establish a schedule to stagger
1941 the implementation of the required rescreening over the 5-year
1942 period, beginning July 31, 2010, through July 31, 2015. If, upon
1943 rescreening, such person has a disqualifying offense that was
1944 not a disqualifying offense at the time of the last screening,
1945 but is a current disqualifying offense and was committed before
1946 the last screening, he or she may apply for an exemption from
1947 the appropriate licensing agency and, if agreed to by the
1948 employer, may continue to perform his or her duties until the
1949 licensing agency renders a decision on the application for
1950 exemption if the person is eligible to apply for an exemption
1951 and the exemption request is received by the agency within 30
1952 days after receipt of the rescreening results by the person. The
1953 rescreening schedule shall be as follows:
1954 (a) Individuals whose last screening was conducted before
1955 December 31, 2003, must be rescreened by July 31, 2013.
1956 (b) Individuals whose last screening was conducted between
1957 January 1, 2004, through December 31, 2007, must be rescreened
1958 by July 31, 2014.
1959 (c) Individuals whose last screening was conducted between
1960 January 1, 2008, through July 31, 2010, must be rescreened by
1961 July 31, 2015.
1962 (6)(5) The costs associated with obtaining the required
1963 screening must be borne by the licensee or the person subject to
1964 screening. Licensees may reimburse persons for these costs. The
1965 Department of Law Enforcement shall charge the agency for
1966 screening pursuant to s. 943.053(3). The agency shall establish
1967 a schedule of fees to cover the costs of screening.
1968 (7)(6)(a) As provided in chapter 435, the agency may grant
1969 an exemption from disqualification to a person who is subject to
1970 this section and who:
1971 1. Does not have an active professional license or
1972 certification from the Department of Health; or
1973 2. Has an active professional license or certification from
1974 the Department of Health but is not providing a service within
1975 the scope of that license or certification.
1976 (b) As provided in chapter 435, the appropriate regulatory
1977 board within the Department of Health, or the department itself
1978 if there is no board, may grant an exemption from
1979 disqualification to a person who is subject to this section and
1980 who has received a professional license or certification from
1981 the Department of Health or a regulatory board within that
1982 department and that person is providing a service within the
1983 scope of his or her licensed or certified practice.
1984 (8)(7) The agency and the Department of Health may adopt
1985 rules pursuant to ss. 120.536(1) and 120.54 to implement this
1986 section, chapter 435, and authorizing statutes requiring
1987 background screening and to implement and adopt criteria
1988 relating to retaining fingerprints pursuant to s. 943.05(2).
1989 (9)(8) There is no unemployment compensation or other
1990 monetary liability on the part of, and no cause of action for
1991 damages arising against, an employer that, upon notice of a
1992 disqualifying offense listed under chapter 435 or this section,
1993 terminates the person against whom the report was issued,
1994 whether or not that person has filed for an exemption with the
1995 Department of Health or the agency.
1996 Section 48. Subsection (9) of section 408.810, Florida
1997 Statutes, is amended to read:
1998 408.810 Minimum licensure requirements.—In addition to the
1999 licensure requirements specified in this part, authorizing
2000 statutes, and applicable rules, each applicant and licensee must
2001 comply with the requirements of this section in order to obtain
2002 and maintain a license.
2003 (9) A controlling interest may not withhold from the agency
2004 any evidence of financial instability, including, but not
2005 limited to, checks returned due to insufficient funds,
2006 delinquent accounts, nonpayment of withholding taxes, unpaid
2007 utility expenses, nonpayment for essential services, or adverse
2008 court action concerning the financial viability of the provider
2009 or any other provider licensed under this part that is under the
2010 control of the controlling interest. A controlling interest
2011 shall notify the agency within 10 days after a court action to
2012 initiate bankruptcy, foreclosure, or eviction proceedings
2013 concerning the provider in which the controlling interest is a
2014 petitioner or defendant. Any person who violates this subsection
2015 commits a misdemeanor of the second degree, punishable as
2016 provided in s. 775.082 or s. 775.083. Each day of continuing
2017 violation is a separate offense.
2018 Section 49. Subsection (3) is added to section 408.813,
2019 Florida Statutes, to read:
2020 408.813 Administrative fines; violations.—As a penalty for
2021 any violation of this part, authorizing statutes, or applicable
2022 rules, the agency may impose an administrative fine.
2023 (3) The agency may impose an administrative fine for a
2024 violation that is not designated as a class I, class II, class
2025 III, or class IV violation. Unless otherwise specified by law,
2026 the amount of the fine may not exceed $500 for each violation.
2027 Unclassified violations include:
2028 (a) Violating any term or condition of a license.
2029 (b) Violating any provision of this part, authorizing
2030 statutes, or applicable rules.
2031 (c) Exceeding licensed capacity.
2032 (d) Providing services beyond the scope of the license.
2033 (e) Violating a moratorium imposed pursuant to s. 408.814.
2034 Section 50. Paragraph (a) of subsection (37) of section
2035 409.912, Florida Statutes, is amended to read:
2036 409.912 Cost-effective purchasing of health care.—The
2037 agency shall purchase goods and services for Medicaid recipients
2038 in the most cost-effective manner consistent with the delivery
2039 of quality medical care. To ensure that medical services are
2040 effectively utilized, the agency may, in any case, require a
2041 confirmation or second physician’s opinion of the correct
2042 diagnosis for purposes of authorizing future services under the
2043 Medicaid program. This section does not restrict access to
2044 emergency services or poststabilization care services as defined
2045 in 42 C.F.R. part 438.114. Such confirmation or second opinion
2046 shall be rendered in a manner approved by the agency. The agency
2047 shall maximize the use of prepaid per capita and prepaid
2048 aggregate fixed-sum basis services when appropriate and other
2049 alternative service delivery and reimbursement methodologies,
2050 including competitive bidding pursuant to s. 287.057, designed
2051 to facilitate the cost-effective purchase of a case-managed
2052 continuum of care. The agency shall also require providers to
2053 minimize the exposure of recipients to the need for acute
2054 inpatient, custodial, and other institutional care and the
2055 inappropriate or unnecessary use of high-cost services. The
2056 agency shall contract with a vendor to monitor and evaluate the
2057 clinical practice patterns of providers in order to identify
2058 trends that are outside the normal practice patterns of a
2059 provider’s professional peers or the national guidelines of a
2060 provider’s professional association. The vendor must be able to
2061 provide information and counseling to a provider whose practice
2062 patterns are outside the norms, in consultation with the agency,
2063 to improve patient care and reduce inappropriate utilization.
2064 The agency may mandate prior authorization, drug therapy
2065 management, or disease management participation for certain
2066 populations of Medicaid beneficiaries, certain drug classes, or
2067 particular drugs to prevent fraud, abuse, overuse, and possible
2068 dangerous drug interactions. The Pharmaceutical and Therapeutics
2069 Committee shall make recommendations to the agency on drugs for
2070 which prior authorization is required. The agency shall inform
2071 the Pharmaceutical and Therapeutics Committee of its decisions
2072 regarding drugs subject to prior authorization. The agency is
2073 authorized to limit the entities it contracts with or enrolls as
2074 Medicaid providers by developing a provider network through
2075 provider credentialing. The agency may competitively bid single
2076 source-provider contracts if procurement of goods or services
2077 results in demonstrated cost savings to the state without
2078 limiting access to care. The agency may limit its network based
2079 on the assessment of beneficiary access to care, provider
2080 availability, provider quality standards, time and distance
2081 standards for access to care, the cultural competence of the
2082 provider network, demographic characteristics of Medicaid
2083 beneficiaries, practice and provider-to-beneficiary standards,
2084 appointment wait times, beneficiary use of services, provider
2085 turnover, provider profiling, provider licensure history,
2086 previous program integrity investigations and findings, peer
2087 review, provider Medicaid policy and billing compliance records,
2088 clinical and medical record audits, and other factors. Providers
2089 are not entitled to enrollment in the Medicaid provider network.
2090 The agency shall determine instances in which allowing Medicaid
2091 beneficiaries to purchase durable medical equipment and other
2092 goods is less expensive to the Medicaid program than long-term
2093 rental of the equipment or goods. The agency may establish rules
2094 to facilitate purchases in lieu of long-term rentals in order to
2095 protect against fraud and abuse in the Medicaid program as
2096 defined in s. 409.913. The agency may seek federal waivers
2097 necessary to administer these policies.
2098 (37)(a) The agency shall implement a Medicaid prescribed
2099 drug spending-control program that includes the following
2100 components:
2101 1. A Medicaid preferred drug list, which shall be a listing
2102 of cost-effective therapeutic options recommended by the
2103 Medicaid Pharmacy and Therapeutics Committee established
2104 pursuant to s. 409.91195 and adopted by the agency for each
2105 therapeutic class on the preferred drug list. At the discretion
2106 of the committee, and when feasible, the preferred drug list
2107 should include at least two products in a therapeutic class. The
2108 agency may post the preferred drug list and updates to the list
2109 on an Internet website without following the rulemaking
2110 procedures of chapter 120. Antiretroviral agents are excluded
2111 from the preferred drug list. The agency shall also limit the
2112 amount of a prescribed drug dispensed to no more than a 34-day
2113 supply unless the drug products’ smallest marketed package is
2114 greater than a 34-day supply, or the drug is determined by the
2115 agency to be a maintenance drug in which case a 100-day maximum
2116 supply may be authorized. The agency may seek any federal
2117 waivers necessary to implement these cost-control programs and
2118 to continue participation in the federal Medicaid rebate
2119 program, or alternatively to negotiate state-only manufacturer
2120 rebates. The agency may adopt rules to administer this
2121 subparagraph. The agency shall continue to provide unlimited
2122 contraceptive drugs and items. The agency must establish
2123 procedures to ensure that:
2124 a. There is a response to a request for prior consultation
2125 by telephone or other telecommunication device within 24 hours
2126 after receipt of a request for prior consultation; and
2127 b. A 72-hour supply of the drug prescribed is provided in
2128 an emergency or when the agency does not provide a response
2129 within 24 hours as required by sub-subparagraph a.
2130 2. Reimbursement to pharmacies for Medicaid prescribed
2131 drugs shall be set at the lowest of: the average wholesale price
2132 (AWP) minus 16.4 percent, the wholesaler acquisition cost (WAC)
2133 plus 1.5 percent, the federal upper limit (FUL), the state
2134 maximum allowable cost (SMAC), or the usual and customary (UAC)
2135 charge billed by the provider.
2136 3. The agency shall develop and implement a process for
2137 managing the drug therapies of Medicaid recipients who are using
2138 significant numbers of prescribed drugs each month. The
2139 management process may include, but is not limited to,
2140 comprehensive, physician-directed medical-record reviews, claims
2141 analyses, and case evaluations to determine the medical
2142 necessity and appropriateness of a patient’s treatment plan and
2143 drug therapies. The agency may contract with a private
2144 organization to provide drug-program-management services. The
2145 Medicaid drug benefit management program shall include
2146 initiatives to manage drug therapies for HIV/AIDS patients,
2147 patients using 20 or more unique prescriptions in a 180-day
2148 period, and the top 1,000 patients in annual spending. The
2149 agency shall enroll any Medicaid recipient in the drug benefit
2150 management program if he or she meets the specifications of this
2151 provision and is not enrolled in a Medicaid health maintenance
2152 organization.
2153 4. The agency may limit the size of its pharmacy network
2154 based on need, competitive bidding, price negotiations,
2155 credentialing, or similar criteria. The agency shall give
2156 special consideration to rural areas in determining the size and
2157 location of pharmacies included in the Medicaid pharmacy
2158 network. A pharmacy credentialing process may include criteria
2159 such as a pharmacy’s full-service status, location, size,
2160 patient educational programs, patient consultation, disease
2161 management services, and other characteristics. The agency may
2162 impose a moratorium on Medicaid pharmacy enrollment if it is
2163 determined that it has a sufficient number of Medicaid
2164 participating providers. The agency must allow dispensing
2165 practitioners to participate as a part of the Medicaid pharmacy
2166 network regardless of the practitioner’s proximity to any other
2167 entity that is dispensing prescription drugs under the Medicaid
2168 program. A dispensing practitioner must meet all credentialing
2169 requirements applicable to his or her practice, as determined by
2170 the agency.
2171 5. The agency shall develop and implement a program that
2172 requires Medicaid practitioners who prescribe drugs to use a
2173 counterfeit-proof prescription pad for Medicaid prescriptions.
2174 The agency shall require the use of standardized counterfeit
2175 proof prescription pads by Medicaid-participating prescribers or
2176 prescribers who write prescriptions for Medicaid recipients. The
2177 agency may implement the program in targeted geographic areas or
2178 statewide.
2179 6. The agency may enter into arrangements that require
2180 manufacturers of generic drugs prescribed to Medicaid recipients
2181 to provide rebates of at least 15.1 percent of the average
2182 manufacturer price for the manufacturer’s generic products.
2183 These arrangements shall require that if a generic-drug
2184 manufacturer pays federal rebates for Medicaid-reimbursed drugs
2185 at a level below 15.1 percent, the manufacturer must provide a
2186 supplemental rebate to the state in an amount necessary to
2187 achieve a 15.1-percent rebate level.
2188 7. The agency may establish a preferred drug list as
2189 described in this subsection, and, pursuant to the establishment
2190 of such preferred drug list, negotiate supplemental rebates from
2191 manufacturers that are in addition to those required by Title
2192 XIX of the Social Security Act and at no less than 14 percent of
2193 the average manufacturer price as defined in 42 U.S.C. s. 1936
2194 on the last day of a quarter unless the federal or supplemental
2195 rebate, or both, equals or exceeds 29 percent. There is no upper
2196 limit on the supplemental rebates the agency may negotiate. The
2197 agency may determine that specific products, brand-name or
2198 generic, are competitive at lower rebate percentages. Agreement
2199 to pay the minimum supplemental rebate percentage guarantees a
2200 manufacturer that the Medicaid Pharmaceutical and Therapeutics
2201 Committee will consider a product for inclusion on the preferred
2202 drug list. However, a pharmaceutical manufacturer is not
2203 guaranteed placement on the preferred drug list by simply paying
2204 the minimum supplemental rebate. Agency decisions will be made
2205 on the clinical efficacy of a drug and recommendations of the
2206 Medicaid Pharmaceutical and Therapeutics Committee, as well as
2207 the price of competing products minus federal and state rebates.
2208 The agency may contract with an outside agency or contractor to
2209 conduct negotiations for supplemental rebates. For the purposes
2210 of this section, the term “supplemental rebates” means cash
2211 rebates. Value-added programs as a substitution for supplemental
2212 rebates are prohibited. The agency may seek any federal waivers
2213 to implement this initiative.
2214 8. The agency shall expand home delivery of pharmacy
2215 products. The agency may amend the state plan and issue a
2216 procurement, as necessary, in order to implement this program.
2217 The procurements must include agreements with a pharmacy or
2218 pharmacies located in the state to provide mail order delivery
2219 services at no cost to the recipients who elect to receive home
2220 delivery of pharmacy products. The procurement must focus on
2221 serving recipients with chronic diseases for which pharmacy
2222 expenditures represent a significant portion of Medicaid
2223 pharmacy expenditures or which impact a significant portion of
2224 the Medicaid population. The agency may seek and implement any
2225 federal waivers necessary to implement this subparagraph.
2226 9. The agency shall limit to one dose per month any drug
2227 prescribed to treat erectile dysfunction.
2228 10.a. The agency may implement a Medicaid behavioral drug
2229 management system. The agency may contract with a vendor that
2230 has experience in operating behavioral drug management systems
2231 to implement this program. The agency may seek federal waivers
2232 to implement this program.
2233 b. The agency, in conjunction with the Department of
2234 Children and Family Services, may implement the Medicaid
2235 behavioral drug management system that is designed to improve
2236 the quality of care and behavioral health prescribing practices
2237 based on best practice guidelines, improve patient adherence to
2238 medication plans, reduce clinical risk, and lower prescribed
2239 drug costs and the rate of inappropriate spending on Medicaid
2240 behavioral drugs. The program may include the following
2241 elements:
2242 (I) Provide for the development and adoption of best
2243 practice guidelines for behavioral health-related drugs such as
2244 antipsychotics, antidepressants, and medications for treating
2245 bipolar disorders and other behavioral conditions; translate
2246 them into practice; review behavioral health prescribers and
2247 compare their prescribing patterns to a number of indicators
2248 that are based on national standards; and determine deviations
2249 from best practice guidelines.
2250 (II) Implement processes for providing feedback to and
2251 educating prescribers using best practice educational materials
2252 and peer-to-peer consultation.
2253 (III) Assess Medicaid beneficiaries who are outliers in
2254 their use of behavioral health drugs with regard to the numbers
2255 and types of drugs taken, drug dosages, combination drug
2256 therapies, and other indicators of improper use of behavioral
2257 health drugs.
2258 (IV) Alert prescribers to patients who fail to refill
2259 prescriptions in a timely fashion, are prescribed multiple same
2260 class behavioral health drugs, and may have other potential
2261 medication problems.
2262 (V) Track spending trends for behavioral health drugs and
2263 deviation from best practice guidelines.
2264 (VI) Use educational and technological approaches to
2265 promote best practices, educate consumers, and train prescribers
2266 in the use of practice guidelines.
2267 (VII) Disseminate electronic and published materials.
2268 (VIII) Hold statewide and regional conferences.
2269 (IX) Implement a disease management program with a model
2270 quality-based medication component for severely mentally ill
2271 individuals and emotionally disturbed children who are high
2272 users of care.
2273 11. The agency shall implement a Medicaid prescription drug
2274 management system.
2275 a. The agency may contract with a vendor that has
2276 experience in operating prescription drug management systems in
2277 order to implement this system. Any management system that is
2278 implemented in accordance with this subparagraph must rely on
2279 cooperation between physicians and pharmacists to determine
2280 appropriate practice patterns and clinical guidelines to improve
2281 the prescribing, dispensing, and use of drugs in the Medicaid
2282 program. The agency may seek federal waivers to implement this
2283 program.
2284 b. The drug management system must be designed to improve
2285 the quality of care and prescribing practices based on best
2286 practice guidelines, improve patient adherence to medication
2287 plans, reduce clinical risk, and lower prescribed drug costs and
2288 the rate of inappropriate spending on Medicaid prescription
2289 drugs. The program must:
2290 (I) Provide for the adoption of best practice guidelines
2291 for the prescribing and use of drugs in the Medicaid program,
2292 including translating best practice guidelines into practice;
2293 reviewing prescriber patterns and comparing them to indicators
2294 that are based on national standards and practice patterns of
2295 clinical peers in their community, statewide, and nationally;
2296 and determine deviations from best practice guidelines.
2297 (II) Implement processes for providing feedback to and
2298 educating prescribers using best practice educational materials
2299 and peer-to-peer consultation.
2300 (III) Assess Medicaid recipients who are outliers in their
2301 use of a single or multiple prescription drugs with regard to
2302 the numbers and types of drugs taken, drug dosages, combination
2303 drug therapies, and other indicators of improper use of
2304 prescription drugs.
2305 (IV) Alert prescribers to recipients who fail to refill
2306 prescriptions in a timely fashion, are prescribed multiple drugs
2307 that may be redundant or contraindicated, or may have other
2308 potential medication problems.
2309 12. The agency may contract for drug rebate administration,
2310 including, but not limited to, calculating rebate amounts,
2311 invoicing manufacturers, negotiating disputes with
2312 manufacturers, and maintaining a database of rebate collections.
2313 13. The agency may specify the preferred daily dosing form
2314 or strength for the purpose of promoting best practices with
2315 regard to the prescribing of certain drugs as specified in the
2316 General Appropriations Act and ensuring cost-effective
2317 prescribing practices.
2318 14. The agency may require prior authorization for
2319 Medicaid-covered prescribed drugs. The agency may prior
2320 authorize the use of a product:
2321 a. For an indication not approved in labeling;
2322 b. To comply with certain clinical guidelines; or
2323 c. If the product has the potential for overuse, misuse, or
2324 abuse.
2325
2326 The agency may require the prescribing professional to provide
2327 information about the rationale and supporting medical evidence
2328 for the use of a drug. The agency shall may post prior
2329 authorization and step-edit criteria and protocol and updates to
2330 the list of drugs that are subject to prior authorization on the
2331 agency’s an Internet website within 21 days after the prior
2332 authorization and step edit criteria and protocol and updates
2333 are approved by the agency. For purposes of this subparagraph,
2334 the term “step edit” means an automatic electronic review of
2335 certain medications subject to prior authorization without
2336 amending its rule or engaging in additional rulemaking.
2337 15. The agency, in conjunction with the Pharmaceutical and
2338 Therapeutics Committee, may require age-related prior
2339 authorizations for certain prescribed drugs. The agency may
2340 preauthorize the use of a drug for a recipient who may not meet
2341 the age requirement or may exceed the length of therapy for use
2342 of this product as recommended by the manufacturer and approved
2343 by the Food and Drug Administration. Prior authorization may
2344 require the prescribing professional to provide information
2345 about the rationale and supporting medical evidence for the use
2346 of a drug.
2347 16. The agency shall implement a step-therapy prior
2348 authorization approval process for medications excluded from the
2349 preferred drug list. Medications listed on the preferred drug
2350 list must be used within the previous 12 months before the
2351 alternative medications that are not listed. The step-therapy
2352 prior authorization may require the prescriber to use the
2353 medications of a similar drug class or for a similar medical
2354 indication unless contraindicated in the Food and Drug
2355 Administration labeling. The trial period between the specified
2356 steps may vary according to the medical indication. The step
2357 therapy approval process shall be developed in accordance with
2358 the committee as stated in s. 409.91195(7) and (8). A drug
2359 product may be approved without meeting the step-therapy prior
2360 authorization criteria if the prescribing physician provides the
2361 agency with additional written medical or clinical documentation
2362 that the product is medically necessary because:
2363 a. There is not a drug on the preferred drug list to treat
2364 the disease or medical condition which is an acceptable clinical
2365 alternative;
2366 b. The alternatives have been ineffective in the treatment
2367 of the beneficiary’s disease; or
2368 c. Based on historic evidence and known characteristics of
2369 the patient and the drug, the drug is likely to be ineffective,
2370 or the number of doses have been ineffective.
2371
2372 The agency shall work with the physician to determine the best
2373 alternative for the patient. The agency may adopt rules waiving
2374 the requirements for written clinical documentation for specific
2375 drugs in limited clinical situations.
2376 17. The agency shall implement a return and reuse program
2377 for drugs dispensed by pharmacies to institutional recipients,
2378 which includes payment of a $5 restocking fee for the
2379 implementation and operation of the program. The return and
2380 reuse program shall be implemented electronically and in a
2381 manner that promotes efficiency. The program must permit a
2382 pharmacy to exclude drugs from the program if it is not
2383 practical or cost-effective for the drug to be included and must
2384 provide for the return to inventory of drugs that cannot be
2385 credited or returned in a cost-effective manner. The agency
2386 shall determine if the program has reduced the amount of
2387 Medicaid prescription drugs which are destroyed on an annual
2388 basis and if there are additional ways to ensure more
2389 prescription drugs are not destroyed which could safely be
2390 reused.
2391 Section 51. Subsections (1), (7), and (8) of section
2392 409.91195, Florida Statutes, are amended to read:
2393 409.91195 Medicaid Pharmaceutical and Therapeutics
2394 Committee.—There is created a Medicaid Pharmaceutical and
2395 Therapeutics Committee within the agency for the purpose of
2396 developing a Medicaid preferred drug list.
2397 (1)(a) The committee shall be composed of 11 members
2398 appointed by the Governor as follows: one member licensed under
2399 chapter 458 or chapter 459 who is nominated by the Florida
2400 Medical Association; one member licensed under chapter 459 who
2401 is nominated by the Florida Osteopathic Medical Association; one
2402 member licensed under chapter 458 or chapter 459 who is
2403 nominated by the American Academy of Family Physicians, Florida
2404 Chapter; one member licensed under chapter 458 or chapter 459
2405 who is nominated by the American Academy of Pediatrics, Florida
2406 Chapter; one member licensed under chapter 458 or chapter 459
2407 nominated by the Florida Psychiatric Society; one member
2408 licensed under chapter 465 who is nominated by the Florida
2409 Pharmacy Association; one member licensed under chapter 465 who
2410 is nominated by the Florida Society of Health System
2411 Pharmacists, Inc.; one member licensed under chapter 465 who is
2412 nominated by the Florida Retail Federation; one member licensed
2413 under chapter 465 who works in a retail setting for an
2414 independent, nonchain pharmacy; one member licensed under
2415 chapter 458 or chapter 459 who is nominated by the Florida
2416 Academy of Physician Assistants; and one consumer representative
2417 who represents a patient advocacy group.
2418 (b) Each member of the committee, except the consumer
2419 representative, must practice in this state and participate in
2420 the Florida Medicaid Fee for Service Pharmacy Program.
2421 (c) The Governor shall appoint the members for 2-year
2422 terms. Members may be appointed to more than one term. The
2423 agency shall serve as staff for the committee and assist the
2424 members with administrative duties. Four members shall be
2425 physicians, licensed under chapter 458; one member licensed
2426 under chapter 459; five members shall be pharmacists licensed
2427 under chapter 465; and one member shall be a consumer
2428 representative. The members shall be appointed to serve for
2429 terms of 2 years from the date of their appointment. Members may
2430 be appointed to more than one term. The agency shall serve as
2431 staff for the committee and assist them with all ministerial
2432 duties. The Governor shall ensure that at least some of the
2433 members of the committee represent Medicaid participating
2434 physicians and pharmacies serving all segments and diversity of
2435 the Medicaid population, and have experience in either
2436 developing or practicing under a preferred drug list. At least
2437 one of the members shall represent the interests of
2438 pharmaceutical manufacturers.
2439 (7) The committee shall ensure that interested parties,
2440 including pharmaceutical manufacturers agreeing to provide a
2441 supplemental rebate as outlined in this chapter, have an
2442 opportunity to present public testimony to the committee with
2443 information or evidence supporting inclusion of a product on the
2444 preferred drug list. Such public testimony shall occur prior to
2445 any recommendations made by the committee for inclusion or
2446 exclusion from the preferred drug list, allow for members of the
2447 committee to ask questions of the presenters of the public
2448 testimony, and allow for 3 minutes of testimony for each drug
2449 reviewed. The agency may not limit the number of interested
2450 parties that provide public testimony. Upon timely notice, the
2451 agency shall ensure that any drug that has been approved or had
2452 any of its particular uses approved by the United States Food
2453 and Drug Administration under a priority review classification
2454 will be reviewed by the committee at the next regularly
2455 scheduled meeting following 3 months of distribution of the drug
2456 to the general public.
2457 (8) The committee shall develop its preferred drug list
2458 recommendations by considering the clinical efficacy, safety,
2459 and cost-effectiveness of a product. If the agency does not
2460 follow a recommendation of the committee, the committee members
2461 must be informed in writing of the agency’s action at the next
2462 meeting of the committee following the reversal of its
2463 recommendation.
2464 Section 52. Subsection (6) of section 429.11, Florida
2465 Statutes, is repealed.
2466 Section 53. Subsection (1) of section 429.294, Florida
2467 Statutes is amended to read:
2468 429.294 Availability of facility records for investigation
2469 of resident’s rights violations and defenses; penalty.—
2470 (1) Failure to provide complete copies of a resident’s
2471 records, including, but not limited to, all medical records and
2472 the resident’s chart, within the control or possession of the
2473 facility within 10 days, in accordance with the provisions of s.
2474 400.141(3)400.145, shall constitute evidence of failure of that
2475 party to comply with good faith discovery requirements and shall
2476 waive the good faith certificate and presuit notice requirements
2477 under this part by the requesting party.
2478 Section 54. Subsections (1) and (5) of section 429.71,
2479 Florida Statutes, are amended to read:
2480 429.71 Classification of violations deficiencies;
2481 administrative fines.—
2482 (1) In addition to the requirements of part II of chapter
2483 408 and in addition to any other liability or penalty provided
2484 by law, the agency may impose an administrative fine on a
2485 provider according to the following classification:
2486 (a) Class I violations are defined in s. 408.813 those
2487 conditions or practices related to the operation and maintenance
2488 of an adult family-care home or to the care of residents which
2489 the agency determines present an imminent danger to the
2490 residents or guests of the facility or a substantial probability
2491 that death or serious physical or emotional harm would result
2492 therefrom. The condition or practice that constitutes a class I
2493 violation must be abated or eliminated within 24 hours, unless a
2494 fixed period, as determined by the agency, is required for
2495 correction. A class I violation deficiency is subject to an
2496 administrative fine in an amount not less than $500 and not
2497 exceeding $1,000 for each violation. A fine may be levied
2498 notwithstanding the correction of the deficiency.
2499 (b) Class II violations are defined in s. 408.813 those
2500 conditions or practices related to the operation and maintenance
2501 of an adult family-care home or to the care of residents which
2502 the agency determines directly threaten the physical or
2503 emotional health, safety, or security of the residents, other
2504 than class I violations. A class II violation is subject to an
2505 administrative fine in an amount not less than $250 and not
2506 exceeding $500 for each violation. A citation for a class II
2507 violation must specify the time within which the violation is
2508 required to be corrected. If a class II violation is corrected
2509 within the time specified, no civil penalty shall be imposed,
2510 unless it is a repeated offense.
2511 (c) Class III violations are defined in s. 408.813 those
2512 conditions or practices related to the operation and maintenance
2513 of an adult family-care home or to the care of residents which
2514 the agency determines indirectly or potentially threaten the
2515 physical or emotional health, safety, or security of residents,
2516 other than class I or class II violations. A class III violation
2517 is subject to an administrative fine in an amount not less than
2518 $100 and not exceeding $250 for each violation. A citation for a
2519 class III violation shall specify the time within which the
2520 violation is required to be corrected. If a class III violation
2521 is corrected within the time specified, no civil penalty shall
2522 be imposed, unless it is a repeated violation offense.
2523 (d) Class IV violations are defined in s. 408.813 those
2524 conditions or occurrences related to the operation and
2525 maintenance of an adult family-care home, or related to the
2526 required reports, forms, or documents, which do not have the
2527 potential of negatively affecting the residents. A provider that
2528 does not correct A class IV violation within the time limit
2529 specified by the agency is subject to an administrative fine in
2530 an amount not less than $50 and not exceeding $100 for each
2531 violation. Any class IV violation that is corrected during the
2532 time the agency survey is conducted will be identified as an
2533 agency finding and not as a violation, unless it is a repeat
2534 violation.
2535 (5) As an alternative to or in conjunction with an
2536 administrative action against a provider, the agency may request
2537 a plan of corrective action that demonstrates a good faith
2538 effort to remedy each violation by a specific date, subject to
2539 the approval of the agency.
2540 Section 55. Section 429.915, Florida Statutes, is amended
2541 to read:
2542 429.915 Conditional license.—In addition to the license
2543 categories available in part II of chapter 408, the agency may
2544 issue a conditional license to an applicant for license renewal
2545 or change of ownership if the applicant fails to meet all
2546 standards and requirements for licensure. A conditional license
2547 issued under this subsection must be limited to a specific
2548 period not exceeding 6 months, as determined by the agency, and
2549 must be accompanied by an approved plan of correction.
2550 Section 56. Subsection (3) of section 430.80, Florida
2551 Statutes, is amended to read:
2552 430.80 Implementation of a teaching nursing home pilot
2553 project.—
2554 (3) To be designated as a teaching nursing home, a nursing
2555 home licensee must, at a minimum:
2556 (a) Provide a comprehensive program of integrated senior
2557 services that include institutional services and community-based
2558 services;
2559 (b) Participate in a nationally recognized accreditation
2560 program and hold a valid accreditation, such as the
2561 accreditation awarded by the Joint Commission on Accreditation
2562 of Healthcare Organizations, or, at the time of initial
2563 designation, possess a Gold Seal Award as conferred by the state
2564 on its licensed nursing home;
2565 (c) Have been in business in this state for a minimum of 10
2566 consecutive years;
2567 (d) Demonstrate an active program in multidisciplinary
2568 education and research that relates to gerontology;
2569 (e) Have a formalized contractual relationship with at
2570 least one accredited health profession education program located
2571 in this state;
2572 (f) Have senior staff members who hold formal faculty
2573 appointments at universities, which must include at least one
2574 accredited health profession education program; and
2575 (g) Maintain insurance coverage pursuant to s.
2576 400.141(1)(q) s. 400.141(1)(s) or proof of financial
2577 responsibility in a minimum amount of $750,000. Such proof of
2578 financial responsibility may include:
2579 1. Maintaining an escrow account consisting of cash or
2580 assets eligible for deposit in accordance with s. 625.52; or
2581 2. Obtaining and maintaining pursuant to chapter 675 an
2582 unexpired, irrevocable, nontransferable and nonassignable letter
2583 of credit issued by any bank or savings association organized
2584 and existing under the laws of this state or any bank or savings
2585 association organized under the laws of the United States that
2586 has its principal place of business in this state or has a
2587 branch office which is authorized to receive deposits in this
2588 state. The letter of credit shall be used to satisfy the
2589 obligation of the facility to the claimant upon presentment of a
2590 final judgment indicating liability and awarding damages to be
2591 paid by the facility or upon presentment of a settlement
2592 agreement signed by all parties to the agreement when such final
2593 judgment or settlement is a result of a liability claim against
2594 the facility.
2595 Section 57. Paragraph (h) of subsection (2) of section
2596 430.81, Florida Statutes, is amended to read:
2597 430.81 Implementation of a teaching agency for home and
2598 community-based care.—
2599 (2) The Department of Elderly Affairs may designate a home
2600 health agency as a teaching agency for home and community-based
2601 care if the home health agency:
2602 (h) Maintains insurance coverage pursuant to s.
2603 400.141(1)(q) s. 400.141(1)(s) or proof of financial
2604 responsibility in a minimum amount of $750,000. Such proof of
2605 financial responsibility may include:
2606 1. Maintaining an escrow account consisting of cash or
2607 assets eligible for deposit in accordance with s. 625.52; or
2608 2. Obtaining and maintaining, pursuant to chapter 675, an
2609 unexpired, irrevocable, nontransferable, and nonassignable
2610 letter of credit issued by any bank or savings association
2611 authorized to do business in this state. This letter of credit
2612 shall be used to satisfy the obligation of the agency to the
2613 claimant upon presentation of a final judgment indicating
2614 liability and awarding damages to be paid by the facility or
2615 upon presentment of a settlement agreement signed by all parties
2616 to the agreement when such final judgment or settlement is a
2617 result of a liability claim against the agency.
2618 Section 58. Paragraph (d) of subsection (9) of section
2619 440.102, Florida Statutes, is repealed.
2620 Section 59. Subsection (9) is added to section 465.014,
2621 Florida Statutes, to read:
2622 465.014 Pharmacy technician.—
2623 (9) This section does not apply to a practitioner
2624 authorized to dispense drugs under s. 465.0276 or any medical
2625 assistant or licensed health care professional acting under the
2626 direct supervision of such practitioner if the practitioner is
2627 treating a patient who provides proof of insurance through a
2628 public or private payor source. Medical personnel under the
2629 direct supervision of the practitioner may perform all
2630 activities required by s. 465.0276.
2631 Section 60. Subsection (1) of section 483.035, Florida
2632 Statutes, is amended to read:
2633 483.035 Clinical laboratories operated by practitioners for
2634 exclusive use; licensure and regulation.—
2635 (1) A clinical laboratory operated by one or more
2636 practitioners licensed under chapter 458, chapter 459, chapter
2637 460, chapter 461, chapter 462, or chapter 466, or as an advanced
2638 registered nurse practitioner licensed under part I in chapter
2639 464, exclusively in connection with the diagnosis and treatment
2640 of their own patients, must be licensed under this part and must
2641 comply with the provisions of this part, except that the agency
2642 shall adopt rules for staffing, for personnel, including
2643 education and training of personnel, for proficiency testing,
2644 and for construction standards relating to the licensure and
2645 operation of the laboratory based upon and not exceeding the
2646 same standards contained in the federal Clinical Laboratory
2647 Improvement Amendments of 1988 and the federal regulations
2648 adopted thereunder.
2649 Section 61. Subsections (1) and (9) of section 483.051,
2650 Florida Statutes, are amended to read:
2651 483.051 Powers and duties of the agency.—The agency shall
2652 adopt rules to implement this part, which rules must include,
2653 but are not limited to, the following:
2654 (1) LICENSING; QUALIFICATIONS.—The agency shall provide for
2655 biennial licensure of all nonwaived clinical laboratories
2656 meeting the requirements of this part and shall prescribe the
2657 qualifications necessary for such licensure, including, but not
2658 limited to, application for or proof of a federal Clinical
2659 Laboratory Improvement Amendment (CLIA) certificate. For
2660 purposes of this section, the term “nonwaived clinical
2661 laboratories” means laboratories that perform any test that the
2662 Centers for Medicare and Medicaid Services has determined does
2663 not qualify for a certificate of waiver under the Clinical
2664 Laboratory Improvement Amendments of 1988 and the federal rules
2665 adopted thereunder.
2666 (9) ALTERNATE-SITE TESTING.—The agency, in consultation
2667 with the Board of Clinical Laboratory Personnel, shall adopt, by
2668 rule, the criteria for alternate-site testing to be performed
2669 under the supervision of a clinical laboratory director. The
2670 elements to be addressed in the rule include, but are not
2671 limited to: a hospital internal needs assessment; a protocol of
2672 implementation including tests to be performed and who will
2673 perform the tests; criteria to be used in selecting the method
2674 of testing to be used for alternate-site testing; minimum
2675 training and education requirements for those who will perform
2676 alternate-site testing, such as documented training, licensure,
2677 certification, or other medical professional background not
2678 limited to laboratory professionals; documented inservice
2679 training as well as initial and ongoing competency validation;
2680 an appropriate internal and external quality control protocol;
2681 an internal mechanism for identifying and tracking alternate
2682 site testing by the central laboratory; and recordkeeping
2683 requirements. Alternate-site testing locations must register
2684 when the clinical laboratory applies to renew its license. For
2685 purposes of this subsection, the term “alternate-site testing”
2686 means any laboratory testing done under the administrative
2687 control of a hospital, but performed out of the physical or
2688 administrative confines of the central laboratory.
2689 Section 62. Section 483.245, Florida Statutes, is amended
2690 to read:
2691 483.245 Rebates prohibited; penalties; private action.—
2692 (1) It is unlawful for any person to pay or receive any
2693 commission, bonus, kickback, or rebate or engage in any split
2694 fee arrangement in any form whatsoever with any dialysis
2695 facility, physician, surgeon, organization, agency, or person,
2696 either directly or indirectly, for patients referred to a
2697 clinical laboratory licensed under this part. A clinical
2698 laboratory licensed under this part is prohibited from placing,
2699 directly or indirectly, through an independent staffing company
2700 or lease arrangement, or otherwise, a specimen collector or
2701 other personnel in any physician’s office, unless the clinical
2702 lab and the physician’s office are owned and operated by the
2703 same entity.
2704 (2) The agency shall adopt rules that assess administrative
2705 penalties for acts prohibited by subsection (1). In the case of
2706 an entity licensed by the agency, such penalties may include any
2707 disciplinary action available to the agency under the
2708 appropriate licensing laws. In the case of an entity not
2709 licensed by the agency, such penalties may include:
2710 (a) A fine not to exceed $1,000;
2711 (b) If applicable, a recommendation by the agency to the
2712 appropriate licensing board that disciplinary action be taken.
2713 (3) Any person aggrieved by a violation of this section may
2714 bring a civil action for appropriate relief, including an action
2715 for a declaratory judgment, injunctive relief, and actual
2716 damages.
2717 Section 63. Section 483.294, Florida Statutes, is amended
2718 to read:
2719 483.294 Inspection of centers.—In accordance with s.
2720 408.811, the agency shall biennially, at least once annually,
2721 inspect the premises and operations of all centers subject to
2722 licensure under this part.
2723 Section 64. Paragraph (a) of subsection (54) of section
2724 499.003, Florida Statutes, is amended to read:
2725 499.003 Definitions of terms used in this part.—As used in
2726 this part, the term:
2727 (54) “Wholesale distribution” means distribution of
2728 prescription drugs to persons other than a consumer or patient,
2729 but does not include:
2730 (a) Any of the following activities, which is not a
2731 violation of s. 499.005(21) if such activity is conducted in
2732 accordance with s. 499.01(2)(g):
2733 1. The purchase or other acquisition by a hospital or other
2734 health care entity that is a member of a group purchasing
2735 organization of a prescription drug for its own use from the
2736 group purchasing organization or from other hospitals or health
2737 care entities that are members of that organization.
2738 2. The sale, purchase, or trade of a prescription drug or
2739 an offer to sell, purchase, or trade a prescription drug by a
2740 charitable organization described in s. 501(c)(3) of the
2741 Internal Revenue Code of 1986, as amended and revised, to a
2742 nonprofit affiliate of the organization to the extent otherwise
2743 permitted by law.
2744 3. The sale, purchase, or trade of a prescription drug or
2745 an offer to sell, purchase, or trade a prescription drug among
2746 hospitals or other health care entities that are under common
2747 control. For purposes of this subparagraph, “common control”
2748 means the power to direct or cause the direction of the
2749 management and policies of a person or an organization, whether
2750 by ownership of stock, by voting rights, by contract, or
2751 otherwise.
2752 4. The sale, purchase, trade, or other transfer of a
2753 prescription drug from or for any federal, state, or local
2754 government agency or any entity eligible to purchase
2755 prescription drugs at public health services prices pursuant to
2756 Pub. L. No. 102-585, s. 602 to a contract provider or its
2757 subcontractor for eligible patients of the agency or entity
2758 under the following conditions:
2759 a. The agency or entity must obtain written authorization
2760 for the sale, purchase, trade, or other transfer of a
2761 prescription drug under this subparagraph from the State Surgeon
2762 General or his or her designee.
2763 b. The contract provider or subcontractor must be
2764 authorized by law to administer or dispense prescription drugs.
2765 c. In the case of a subcontractor, the agency or entity
2766 must be a party to and execute the subcontract.
2767 d. A contract provider or subcontractor must maintain
2768 separate and apart from other prescription drug inventory any
2769 prescription drugs of the agency or entity in its possession.
2770 d.e. The contract provider and subcontractor must maintain
2771 and produce immediately for inspection all records of movement
2772 or transfer of all the prescription drugs belonging to the
2773 agency or entity, including, but not limited to, the records of
2774 receipt and disposition of prescription drugs. Each contractor
2775 and subcontractor dispensing or administering these drugs must
2776 maintain and produce records documenting the dispensing or
2777 administration. Records that are required to be maintained
2778 include, but are not limited to, a perpetual inventory itemizing
2779 drugs received and drugs dispensed by prescription number or
2780 administered by patient identifier, which must be submitted to
2781 the agency or entity quarterly.
2782 e.f. The contract provider or subcontractor may administer
2783 or dispense the prescription drugs only to the eligible patients
2784 of the agency or entity or must return the prescription drugs
2785 for or to the agency or entity. The contract provider or
2786 subcontractor must require proof from each person seeking to
2787 fill a prescription or obtain treatment that the person is an
2788 eligible patient of the agency or entity and must, at a minimum,
2789 maintain a copy of this proof as part of the records of the
2790 contractor or subcontractor required under sub-subparagraph e.
2791 f.g. In addition to the departmental inspection authority
2792 set forth in s. 499.051, the establishment of the contract
2793 provider and subcontractor and all records pertaining to
2794 prescription drugs subject to this subparagraph shall be subject
2795 to inspection by the agency or entity. All records relating to
2796 prescription drugs of a manufacturer under this subparagraph
2797 shall be subject to audit by the manufacturer of those drugs,
2798 without identifying individual patient information.
2799 Section 65. Section 624.49, Florida Statutes, is created to
2800 read:
2801 624.49 Prohibition on contracts.—Notwithstanding any other
2802 provision of law, a managed care entity, insurance carrier,
2803 self-insured entity, or third-party administrator, or an agent
2804 thereof, governed by state law, may not impose a contracted
2805 reimbursement rate on a medical provider for goods or services
2806 provided or rendered pursuant to chapter 440 unless the carrier
2807 directly contracts with the provider for that rate.
2808 Section 66. Effective May 1, 2012, paragraph (h) is added
2809 to subsection (1) of section 627.602, Florida Statutes, to read:
2810 627.602 Scope, format of policy.—
2811 (1) Each health insurance policy delivered or issued for
2812 delivery to any person in this state must comply with all
2813 applicable provisions of this code and all of the following
2814 requirements:
2815 (h) Section 641.312 and the provisions of the Employee
2816 Retirement Income Security Act of 1974, as implemented by 29
2817 C.F.R. s. 2560.503-1, relating to internal grievances. This
2818 paragraph does not apply to a health insurance policy that is
2819 subject to the Subscriber Assistance Program in s. 408.7056.
2820 Section 67. Effective May 1, 2012, section 627.6513,
2821 Florida Statutes, is created to read:
2822 627.6513 Section 641.312 and the provisions of the Employee
2823 Retirement Income Security Act of 1974, as implemented by 29
2824 C.F.R. s. 2560.503-1, relating to internal grievances, apply to
2825 all group health insurance policies issued under this part. This
2826 section does not apply to a group health insurance policy that
2827 is subject to the Subscriber Assistance Program in s. 408.7056.
2828 Section 68. Effective May 1, 2012, section 641.312, Florida
2829 Statutes, is created to read:
2830 641.312 The Financial Services Commission shall adopt rules
2831 to administer the provisions of the National Association of
2832 Insurance Commissioners’ Uniform Health Carrier External Review
2833 Model Act, dated April 2010. This section does not apply to a
2834 health maintenance contract that is subject to the Subscriber
2835 Assistance Program in s. 409.7056.
2836 Section 69. Subsection (13) of section 651.118, Florida
2837 Statutes, is amended to read:
2838 651.118 Agency for Health Care Administration; certificates
2839 of need; sheltered beds; community beds.—
2840 (13) Residents, as defined in this chapter, are not
2841 considered new admissions for the purpose of s. 400 141(1)(n)1.d
2842 s. 400.141(1)(o)1.d.
2843 Section 70. In the interim between this act becoming law
2844 and the 2013 Regular Session of the Legislature, the Division of
2845 Statutory Revision shall provide the relevant substantive
2846 committees of the Senate and the House of Representatives with
2847 assistance, upon request, to enable such committees to prepare
2848 draft legislation to correct the names of accrediting
2849 organizations in the related Florida Statutes.
2850 Section 71. Except as otherwise expressly provided in this
2851 act, and except for this section, which shall take effect upon
2852 this act becoming a law, this act shall take effect July 1,
2853 2012.