Florida Senate - 2012 CS for SB 1884
By the Committee on Health Regulation; and Senator Garcia
588-02736A-12 20121884c1
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.; redefining the
32 term “accrediting organizations” as it applies to the
33 regulation of hospitals and other licensed facilities;
34 conforming a cross-reference; amending s. 395.003,
35 F.S.; 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. 395.3025, F.S.; authorizing the disclosure
66 of patient records to the Department of Health rather
67 than the Agency for Health Care Administration in
68 accordance with an issued subpoena; requiring the
69 department, rather than the agency, to make available,
70 upon written request by a practitioner against whom
71 probable cause has been found, any patient records
72 that form the basis of the determination of probable
73 cause; amending s. 395.3036, F.S.; correcting a cross
74 reference; repealing s. 395.3037, F.S., relating to
75 redundant definitions for the Department of Health and
76 the Agency for Health Care Administration; amending s.
77 395.602, F.S.; revising the definition of the term
78 “rural hospital” to delete an obsolete provision;
79 amending s. 400.021, F.S.; revising the definitions of
80 the terms “geriatric outpatient clinic” and “resident
81 care plan”; amending s. 400.275, F.S.; revising agency
82 duties with regard to training nursing home surveyor
83 teams; revising requirements for team members;
84 amending s. 400.474, F.S.; revising the requirements
85 for a quarterly report submitted to the Agency for
86 Health Care Administration by each home health agency;
87 amending s. 400.484, F.S.; revising the classification
88 of violations by a home health agency for which the
89 agency imposes an administrative fine; amending and
90 reenacting s. 400.506, F.S., relating to licensure of
91 nurse registries, to incorporate the amendment made to
92 s. 400.509, F.S., in a reference thereto; authorizing
93 an administrator to manage up to five nurse registries
94 under certain circumstances; requiring an
95 administrator to designate, in writing, for each
96 licensed entity, a qualified alternate administrator
97 to serve during the administrator’s absence; amending
98 s. 400.509, F.S.; providing that organizations that
99 provide companion services only to persons with
100 developmental disabilities, under contract with the
101 Agency for Persons with Disabilities, are exempt from
102 registration with the Agency for Health Care
103 Administration; amending s. 400.601, F.S.; redefining
104 the term “hospice” to include a limited liability
105 company as it relates to nursing homes and related
106 health care facilities; amending s. 400.606, F.S.;
107 revising the content requirements of the plan
108 accompanying an initial or change-of-ownership
109 application for licensure of a hospice; revising
110 requirements relating to certificates of need for
111 certain hospice facilities; amending s. 400.915, F.S.;
112 correcting an obsolete cross-reference to
113 administrative rules; amending s. 400.931, F.S.;
114 requiring each applicant for initial licensure, change
115 of ownership, or license renewal to operate a licensed
116 home medical equipment provider at a location outside
117 the state to submit documentation of accreditation, or
118 an application for accreditation, from an accrediting
119 organization that is recognized by the Agency for
120 Health Care Administration; requiring an applicant
121 that has applied for accreditation to provide proof of
122 accreditation within a specified time; deleting a
123 requirement that an applicant for a home medical
124 equipment provider license submit a surety bond to the
125 agency; amending s. 400.967, F.S.; revising the
126 classification of violations by intermediate care
127 facilities for the developmentally disabled; providing
128 a penalty for certain violations; amending s.
129 400.9905, F.S.; revising the definitions of the terms
130 “clinic” and “portable equipment provider”;
131 authorizing the Agency for Health Care Administration
132 to deny or revoke an exemption from licensure based on
133 certain criteria if a health care clinic receives
134 payment for health care services under personal injury
135 protection insurance coverage; including health
136 services provided at multiple locations within the
137 definition of the term “portable health service or
138 equipment provider”; amending s. 400.991, F.S.;
139 conforming terminology; revising application
140 requirements relating to documentation of financial
141 ability to operate a mobile clinic; amending s.
142 408.033, F.S.; providing that fees assessed on
143 selected health care facilities and organizations may
144 be collected prospectively at the time of licensure
145 renewal and prorated for the licensing period;
146 amending s. 408.034, F.S.; revising agency authority
147 relating to licensing of intermediate care facilities
148 for the developmentally disabled; amending s. 408.036,
149 F.S.; deleting an exemption from certain certificate
150 of-need review requirements for a hospice or a hospice
151 inpatient facility; amending s. 408.037, F.S.;
152 revising requirements for the financial information to
153 be included in an application for a certificate of
154 need; amending s. 408.043, F.S.; revising requirements
155 for certain freestanding inpatient hospice care
156 facilities to obtain a certificate of need; amending
157 s. 408.061, F.S.; revising data reporting requirements
158 for health care facilities; amending s. 408.07, F.S.;
159 deleting a cross-reference; amending s. 408.10, F.S.;
160 removing agency authority to investigate certain
161 consumer complaints; amending s. 408.7056, F.S.;
162 providing that the Subscriber Assistance Program
163 applies to health plans that meet certain
164 requirements; repealing s. 408.802(11), F.S.; removing
165 applicability of part II of ch. 408, F.S., relating to
166 general licensure requirements, to private review
167 agents; amending s. 408.804, F.S.; providing penalties
168 for altering, defacing, or falsifying a license
169 certificate issued by the agency or displaying such an
170 altered, defaced, or falsified certificate; amending
171 s. 408.806, F.S.; revising agency responsibilities for
172 notification of licensees of impending expiration of a
173 license; requiring payment of a late fee for a license
174 application to be considered complete under certain
175 circumstances; amending s. 408.8065, F.S.; revising
176 the requirements for becoming licensed as a home
177 health agency, home medical equipment provider, or
178 health care clinic; amending s. 408.809, F.S.;
179 revising provisions to include a schedule for
180 background rescreenings of certain employees; amending
181 s. 408.810, F.S.; requiring that the controlling
182 interest of a health care licensee notify the agency
183 of certain court proceedings; providing a penalty;
184 amending s. 408.813, F.S.; authorizing the agency to
185 impose fines for unclassified violations of part II of
186 ch. 408, F.S.; amending s. 409.912, F.S.; revising the
187 components of the Medicaid prescribed-drug spending
188 control program; amending s. 409.91195, F.S.; revising
189 the membership of the Medicaid Pharmaceutical and
190 Therapeutics Committee; providing the requirements for
191 the members; providing terms of membership; requiring
192 the Agency for Health Care Administration to serve as
193 staff for the committee and assist the committee with
194 its duties; providing additional requirements for
195 presenting public testimony to include a product on a
196 preferred drug list; requiring that the committee be
197 informed in writing of the agency’s action when the
198 agency does not follow the recommendation of the
199 committee; amending s. 409.975, F.S.; providing that
200 an essential provider and a hospital that is necessary
201 for a managed care plan to demonstrate an adequate
202 network as determined by the Agency for Health Care
203 Administration is part of that managed care plan’s
204 network for purposes of the provider’s or hospital’s
205 application for enrollment or expansion in the
206 Medicaid program; requiring that a managed care plan’s
207 payment under this provision to an essential provider
208 be made in accordance with s. 409.975, F.S., regarding
209 managed care plan accountability; repealing s.
210 429.11(6), F.S., relating to provisional licenses for
211 assisted living facilities; amending s. 429.294, F.S.;
212 revising a cross-reference; amending s. 429.71, F.S.;
213 revising the classification of violations; amending s.
214 429.915, F.S.; revising agency responsibilities
215 regarding the issuance of conditional licenses;
216 amending ss. 430.80 and 430.81, F.S.; conforming
217 cross-references; repealing s. 440.102(9)(d), F.S.,
218 relating to a requirement that laboratories submit to
219 the Agency for Health Care Administration a monthly
220 report containing statistical information regarding
221 the testing of employees and job applicants; amending
222 s. 483.035, F.S.; providing for a clinical laboratory
223 to be operated by certain nurses; amending s. 483.051,
224 F.S.; requiring the Agency for Health Care
225 Administration to provide for biennial licensure of
226 all nonwaived laboratories that meet certain
227 requirements; requiring the agency to prescribe
228 qualifications for such licensure; defining nonwaived
229 laboratories as laboratories that do not have a
230 certificate of waiver from the Centers for Medicare
231 and Medicaid Services; deleting requirements for the
232 registration of an alternate site testing location
233 when the clinical laboratory applies to renew its
234 license; amending s. 483.245, F.S.; prohibiting a
235 clinical laboratory from placing a specimen collector
236 or other personnel in any physician’s office, unless
237 the clinical lab and the physician’s office are owned
238 and operated by the same entity; authorizing a person
239 who is aggrieved by a violation to bring a civil
240 action for appropriate relief; amending s. 483.294,
241 F.S.; revising the frequency of agency inspections of
242 multiphasic health testing centers; amending s.
243 499.003, F.S.; redefining the term “wholesale
244 distribution” with regard to the Florida Drug and
245 Cosmetic Act to remove certain requirements governing
246 prescription drug inventories; amending and creating,
247 respectively, ss. 627.602 and 627.6513, F.S.;
248 providing that the Uniform Health Carrier External
249 Review Model Act and the Employee Retirement Income
250 Security Act apply to individual and group health
251 insurance policies except those subject to the
252 Subscriber Assistance Program under s. 408.7056, F.S.;
253 creating s. 641.312, F.S.; requiring the Office of
254 Insurance Regulation within the Department of
255 Financial Services to administer the National
256 Association of Insurance Commissioners’ Uniform Health
257 Carrier External Review Model Act; providing that the
258 Uniform Health Carrier External Review Model Act does
259 not apply to a health maintenance contract that is
260 subject to the Subscriber Assistance Program under s.
261 408.7056, F.S.; amending s. 651.118, F.S.; conforming
262 a cross-reference; providing a directive to the
263 Division of Statutory Revision; providing effective
264 dates.
265
266 Be It Enacted by the Legislature of the State of Florida:
267
268 Section 1. Subsection (1) of section 83.42, Florida
269 Statutes, is amended to read:
270 83.42 Exclusions from application of part.—This part does
271 not apply to:
272 (1) Residency or detention in a facility, whether public or
273 private, when residence or detention is incidental to the
274 provision of medical, geriatric, educational, counseling,
275 religious, or similar services. For residents of a facility
276 licensed under part II of chapter 400, the provisions of s.
277 400.0255 are the exclusive procedures for all transfers and
278 discharges.
279 Section 2. Present paragraphs (f) through (k) of subsection
280 (10) of section 112.0455, Florida Statutes, are redesignated as
281 paragraphs (e) through (j), respectively, and present paragraph
282 (e) of subsection (10), subsection (12), and paragraph (e) of
283 subsection (14) of that section are amended to read:
284 112.0455 Drug-Free Workplace Act.—
285 (10) EMPLOYER PROTECTION.—
286 (e) Nothing in this section shall be construed to operate
287 retroactively, and nothing in this section shall abrogate the
288 right of an employer under state law to conduct drug tests prior
289 to January 1, 1990. A drug test conducted by an employer prior
290 to January 1, 1990, is not subject to this section.
291 (12) DRUG-TESTING STANDARDS; LABORATORIES.—
292 (a) The requirements of part II of chapter 408 apply to the
293 provision of services that require licensure pursuant to this
294 section and part II of chapter 408 and to entities licensed by
295 or applying for such licensure from the Agency for Health Care
296 Administration pursuant to this section. A license issued by the
297 agency is required in order to operate a laboratory.
298 (b) A laboratory may analyze initial or confirmation drug
299 specimens only if:
300 1. The laboratory is licensed and approved by the Agency
301 for Health Care Administration using criteria established by the
302 United States Department of Health and Human Services as general
303 guidelines for modeling the state drug testing program and in
304 accordance with part II of chapter 408. Each applicant for
305 licensure and licensee must comply with all requirements of part
306 II of chapter 408.
307 2. The laboratory has written procedures to ensure chain of
308 custody.
309 3. The laboratory follows proper quality control
310 procedures, including, but not limited to:
311 a. The use of internal quality controls including the use
312 of samples of known concentrations which are used to check the
313 performance and calibration of testing equipment, and periodic
314 use of blind samples for overall accuracy.
315 b. An internal review and certification process for drug
316 test results, conducted by a person qualified to perform that
317 function in the testing laboratory.
318 c. Security measures implemented by the testing laboratory
319 to preclude adulteration of specimens and drug test results.
320 d. Other necessary and proper actions taken to ensure
321 reliable and accurate drug test results.
322 (c) A laboratory shall disclose to the employer a written
323 test result report within 7 working days after receipt of the
324 sample. All laboratory reports of a drug test result shall, at a
325 minimum, state:
326 1. The name and address of the laboratory which performed
327 the test and the positive identification of the person tested.
328 2. Positive results on confirmation tests only, or negative
329 results, as applicable.
330 3. A list of the drugs for which the drug analyses were
331 conducted.
332 4. The type of tests conducted for both initial and
333 confirmation tests and the minimum cutoff levels of the tests.
334 5. Any correlation between medication reported by the
335 employee or job applicant pursuant to subparagraph (8)(b)2. and
336 a positive confirmed drug test result.
337
338 A No report may not shall disclose the presence or absence of
339 any drug other than a specific drug and its metabolites listed
340 pursuant to this section.
341 (d) The laboratory shall submit to the Agency for Health
342 Care Administration a monthly report with statistical
343 information regarding the testing of employees and job
344 applicants. The reports shall include information on the methods
345 of analyses conducted, the drugs tested for, the number of
346 positive and negative results for both initial and confirmation
347 tests, and any other information deemed appropriate by the
348 Agency for Health Care Administration. No monthly report shall
349 identify specific employees or job applicants.
350 (d)(e) Laboratories shall provide technical assistance to
351 the employer, employee, or job applicant for the purpose of
352 interpreting any positive confirmed test results which could
353 have been caused by prescription or nonprescription medication
354 taken by the employee or job applicant.
355 (14) DISCIPLINE REMEDIES.—
356 (e) Upon resolving an appeal filed pursuant to paragraph
357 (c), and finding a violation of this section, the commission may
358 order the following relief:
359 1. Rescind the disciplinary action, expunge related records
360 from the personnel file of the employee or job applicant and
361 reinstate the employee.
362 2. Order compliance with paragraph (10)(f) (10)(g).
363 3. Award back pay and benefits.
364 4. Award the prevailing employee or job applicant the
365 necessary costs of the appeal, reasonable attorney’s fees, and
366 expert witness fees.
367 Section 3. Subsection (15) of section 318.21, Florida
368 Statutes, is amended to read:
369 318.21 Disposition of civil penalties by county courts.—All
370 civil penalties received by a county court pursuant to the
371 provisions of this chapter shall be distributed and paid monthly
372 as follows:
373 (15) Of the additional fine assessed under s. 318.18(3)(e)
374 for a violation of s. 316.1893, 50 percent of the moneys
375 received from the fines shall be remitted to the Department of
376 Revenue and deposited into the Brain and Spinal Cord Injury
377 Trust Fund of Department of Health and appropriated to the
378 Department of Health Agency for Health Care Administration as
379 general revenue to provide an enhanced Medicaid payment to
380 nursing homes that serve Medicaid recipients who have with brain
381 and spinal cord injuries that are medically complex and who are
382 technologically and respiratory dependent. The remaining 50
383 percent of the moneys received from the enhanced fine imposed
384 under s. 318.18(3)(e) shall be remitted to the Department of
385 Revenue and deposited into the Department of Health Emergency
386 Medical Services Trust Fund to provide financial support to
387 certified trauma centers in the counties where enhanced penalty
388 zones are established to ensure the availability and
389 accessibility of trauma services. Funds deposited into the
390 Emergency Medical Services Trust Fund under this subsection
391 shall be allocated as follows:
392 (a) Fifty percent shall be allocated equally among all
393 Level I, Level II, and pediatric trauma centers in recognition
394 of readiness costs for maintaining trauma services.
395 (b) Fifty percent shall be allocated among Level I, Level
396 II, and pediatric trauma centers based on each center’s relative
397 volume of trauma cases as reported in the Department of Health
398 Trauma Registry.
399 Section 4. Section 383.325, Florida Statutes, is repealed.
400 Section 5. Section 385.2031, Florida Statutes, is created
401 to read:
402 385.2031 Resource for research in the prevention and
403 treatment of diabetes.—The Florida Hospital/Sanford-Burnham
404 Translational Research Institute for Metabolism and Diabetes is
405 designated as a resource in this state for research in the
406 prevention and treatment of diabetes.
407 Section 6. Subsection (1) of section 395.002, Florida
408 Statutes, is amended to read:
409 395.002 Definitions.—As used in this chapter:
410 (1) “Accrediting organizations” means national
411 accreditation organizations that are approved by the Centers for
412 Medicare and Medicaid Services and whose standards incorporate
413 comparable licensure regulations required by the state the Joint
414 Commission on Accreditation of Healthcare Organizations, the
415 American Osteopathic Association, the Commission on
416 Accreditation of Rehabilitation Facilities, and the
417 Accreditation Association for Ambulatory Health Care, Inc.
418 Section 7. Paragraph (c) of subsection (1) and subsection
419 (6) of section 395.003, Florida Statutes, are amended to read:
420 395.003 Licensure; denial, suspension, and revocation.—
421 (1)
422 (c) Until July 1, 2006, additional emergency departments
423 located off the premises of licensed hospitals may not be
424 authorized by the agency.
425 (6) A specialty hospital may not provide any service or
426 regularly serve any population group beyond those services or
427 groups specified in its license. A specialty-licensed children’s
428 hospital that is authorized to provide pediatric cardiac
429 catheterization and pediatric open-heart surgery services may
430 provide cardiovascular service to adults who, as children, were
431 previously served by the hospital for congenital heart disease,
432 or to those patients who are referred for a specialized
433 procedure only for congenital heart disease by an adult
434 hospital, without obtaining additional licensure as a provider
435 of adult cardiovascular services. The agency may request
436 documentation as needed to support patient selection and
437 treatment. This subsection does not apply to a specialty
438 licensed children’s hospital that is already licensed to provide
439 adult cardiovascular services. A specialty–licensed children’s
440 hospital that has at least 50 licensed neonatal intensive care
441 unit beds may provide obstetrical services, including labor and
442 delivery, which are restricted to the diagnosis, care, and
443 treatment of pregnant women of any age who have:
444 (a) At least one maternal or fetal characteristic or
445 condition that would characterize the pregnancy or delivery as
446 high-risk; or
447 (b) Received medical advice or a diagnosis indicating their
448 fetus will require at least one perinatal intervention.
449
450 The agency shall adopt rules that establish standards and
451 guidelines for admission to any program that qualifies under
452 this subsection.
453 Section 8. Subsection (3) of section 395.0161, Florida
454 Statutes, is amended to read:
455 395.0161 Licensure inspection.—
456 (3) In accordance with s. 408.805, an applicant or licensee
457 shall pay a fee for each license application submitted under
458 this part, part II of chapter 408, and applicable rules. With
459 the exception of state-operated licensed facilities, each
460 facility licensed under this part shall pay to the agency, at
461 the time of inspection, the following fees:
462 (a) Inspection for licensure.—A fee shall be paid which is
463 not less than $8 per hospital bed, nor more than $12 per
464 hospital bed, except that the minimum fee shall be $400 per
465 facility.
466 (b) Inspection for lifesafety only.—A fee shall be paid
467 which is not less than 75 cents per hospital bed, nor more than
468 $1.50 per hospital bed, except that the minimum fee shall be $40
469 per facility.
470 Section 9. Subsections (2) and (4) of section 395.0193,
471 Florida Statutes, are amended to read:
472 395.0193 Licensed facilities; peer review; disciplinary
473 powers; agency or partnership with physicians.—
474 (2) Each licensed facility, as a condition of licensure,
475 shall provide for peer review of physicians who deliver health
476 care services at the facility. Each licensed facility shall
477 develop written, binding procedures by which such peer review
478 shall be conducted. Such procedures must shall include:
479 (a) Mechanism for choosing the membership of the body or
480 bodies that conduct peer review.
481 (b) Adoption of rules of order for the peer review process.
482 (c) Fair review of the case with the physician involved.
483 (d) Mechanism to identify and avoid conflict of interest on
484 the part of the peer review panel members.
485 (e) Recording of agendas and minutes which do not contain
486 confidential material, for review by the Division of Medical
487 Quality Assurance of the department Health Quality Assurance of
488 the agency.
489 (f) Review, at least annually, of the peer review
490 procedures by the governing board of the licensed facility.
491 (g) Focus of the peer review process on review of
492 professional practices at the facility to reduce morbidity and
493 mortality and to improve patient care.
494 (4) Pursuant to ss. 458.337 and 459.016, any disciplinary
495 actions taken under subsection (3) shall be reported in writing
496 to the Division of Medical Quality Assurance of the department
497 Health Quality Assurance of the agency within 30 working days
498 after its initial occurrence, regardless of the pendency of
499 appeals to the governing board of the hospital. The notification
500 shall identify the disciplined practitioner, the action taken,
501 and the reason for such action. All final disciplinary actions
502 taken under subsection (3), if different from those which were
503 reported to the department agency within 30 days after the
504 initial occurrence, shall be reported within 10 working days to
505 the Division of Medical Quality Assurance of the department
506 Health Quality Assurance of the agency in writing and shall
507 specify the disciplinary action taken and the specific grounds
508 therefor. The division shall review each report and determine
509 whether it potentially involved conduct by the licensee that is
510 subject to disciplinary action, in which case s. 456.073 shall
511 apply. The reports are not subject to inspection under s.
512 119.07(1) even if the division’s investigation results in a
513 finding of probable cause.
514 Section 10. Section 395.1023, Florida Statutes, is amended
515 to read:
516 395.1023 Child abuse and neglect cases; duties.—Each
517 licensed facility shall adopt a protocol that, at a minimum,
518 requires the facility to:
519 (1) Incorporate a facility policy that every staff member
520 has an affirmative duty to report, pursuant to chapter 39, any
521 actual or suspected case of child abuse, abandonment, or
522 neglect; and
523 (2) In any case involving suspected child abuse,
524 abandonment, or neglect, designate, at the request of the
525 Department of Children and Family Services, a staff physician to
526 act as a liaison between the hospital and the Department of
527 Children and Family Services office which is investigating the
528 suspected abuse, abandonment, or neglect, and the child
529 protection team, as defined in s. 39.01, when the case is
530 referred to such a team.
531
532 Each general hospital and appropriate specialty hospital shall
533 comply with the provisions of this section and shall notify the
534 agency and the Department of Children and Family Services of its
535 compliance by sending a copy of its policy to the agency and the
536 Department of Children and Family Services as required by rule.
537 The failure by a general hospital or appropriate specialty
538 hospital to comply shall be punished by a fine not exceeding
539 $1,000, to be fixed, imposed, and collected by the agency. Each
540 day in violation is considered a separate offense.
541 Section 11. Subsection (2) and paragraph (d) of subsection
542 (3) of section 395.1041, Florida Statutes, are amended to read:
543 395.1041 Access to emergency services and care.—
544 (2) INVENTORY OF HOSPITAL EMERGENCY SERVICES.—The agency
545 shall establish and maintain an inventory of hospitals with
546 emergency services. The inventory shall list all services within
547 the service capability of the hospital, and such services shall
548 appear on the face of the hospital license. Each hospital having
549 emergency services shall notify the agency of its service
550 capability in the manner and form prescribed by the agency. The
551 agency shall use the inventory to assist emergency medical
552 services providers and others in locating appropriate emergency
553 medical care. The inventory shall also be made available to the
554 general public. On or before August 1, 1992, the agency shall
555 request that each hospital identify the services which are
556 within its service capability. On or before November 1, 1992,
557 the agency shall notify each hospital of the service capability
558 to be included in the inventory. The hospital has 15 days from
559 the date of receipt to respond to the notice. By December 1,
560 1992, the agency shall publish a final inventory. Each hospital
561 shall reaffirm its service capability when its license is
562 renewed and shall notify the agency of the addition of a new
563 service or the termination of a service prior to a change in its
564 service capability.
565 (3) EMERGENCY SERVICES; DISCRIMINATION; LIABILITY OF
566 FACILITY OR HEALTH CARE PERSONNEL.—
567 (d)1. Every hospital shall ensure the provision of services
568 within the service capability of the hospital, at all times,
569 either directly or indirectly through an arrangement with
570 another hospital, through an arrangement with one or more
571 physicians, or as otherwise made through prior arrangements. A
572 hospital may enter into an agreement with another hospital for
573 purposes of meeting its service capability requirement, and
574 appropriate compensation or other reasonable conditions may be
575 negotiated for these backup services.
576 2. If any arrangement requires the provision of emergency
577 medical transportation, such arrangement must be made in
578 consultation with the applicable provider and may not require
579 the emergency medical service provider to provide transportation
580 that is outside the routine service area of that provider or in
581 a manner that impairs the ability of the emergency medical
582 service provider to timely respond to prehospital emergency
583 calls.
584 3. A hospital is shall not be required to ensure service
585 capability at all times as required in subparagraph 1. if, prior
586 to the receiving of any patient needing such service capability,
587 such hospital has demonstrated to the agency that it lacks the
588 ability to ensure such capability and it has exhausted all
589 reasonable efforts to ensure such capability through backup
590 arrangements. In reviewing a hospital’s demonstration of lack of
591 ability to ensure service capability, the agency shall consider
592 factors relevant to the particular case, including the
593 following:
594 a. Number and proximity of hospitals with the same service
595 capability.
596 b. Number, type, credentials, and privileges of
597 specialists.
598 c. Frequency of procedures.
599 d. Size of hospital.
600 4. The agency shall publish proposed rules implementing a
601 reasonable exemption procedure by November 1, 1992. Subparagraph
602 1. shall become effective upon the effective date of said rules
603 or January 31, 1993, whichever is earlier. For a period not to
604 exceed 1 year from the effective date of subparagraph 1., a
605 hospital requesting an exemption shall be deemed to be exempt
606 from offering the service until the agency initially acts to
607 deny or grant the original request. The agency has 45 days after
608 from the date of receipt of the request to approve or deny the
609 request. After the first year from the effective date of
610 subparagraph 1., If the agency fails to initially act within
611 that the time period, the hospital is deemed to be exempt from
612 offering the service until the agency initially acts to deny the
613 request.
614 Section 12. Section 395.1046, Florida Statutes, is
615 repealed.
616 Section 13. Paragraph (e) of subsection (1) of section
617 395.1055, Florida Statutes, is amended to read:
618 395.1055 Rules and enforcement.—
619 (1) The agency shall adopt rules pursuant to ss. 120.536(1)
620 and 120.54 to implement the provisions of this part, which shall
621 include reasonable and fair minimum standards for ensuring that:
622 (e) Licensed facility beds conform to minimum space,
623 equipment, and furnishings standards as specified by the agency,
624 the Florida Building Code, and the Florida Fire Prevention Code
625 department.
626 Section 14. Paragraph (e) of subsection (4) of section
627 395.3025, Florida Statutes, is amended to read:
628 395.3025 Patient and personnel records; copies;
629 examination.—
630 (4) Patient records are confidential and must not be
631 disclosed without the consent of the patient or his or her legal
632 representative, but appropriate disclosure may be made without
633 such consent to:
634 (e) The department agency upon subpoena issued pursuant to
635 s. 456.071., but The records obtained thereby must be used
636 solely for the purpose of the agency, the department, and the
637 appropriate professional board in an its investigation,
638 prosecution, and appeal of disciplinary proceedings. If the
639 department agency requests copies of the records, the facility
640 shall charge a fee pursuant to this section no more than its
641 actual copying costs, including reasonable staff time. The
642 records must be sealed and must not be available to the public
643 pursuant to s. 119.07(1) or any other statute providing access
644 to records, nor may they be available to the public as part of
645 the record of investigation for and prosecution in disciplinary
646 proceedings made available to the public by the agency, the
647 department, or the appropriate regulatory board. However, the
648 department agency must make available, upon written request by a
649 practitioner against whom probable cause has been found, any
650 such records that form the basis of the determination of
651 probable cause.
652 Section 15. Subsection (2) of section 395.3036, Florida
653 Statutes, is amended to read:
654 395.3036 Confidentiality of records and meetings of
655 corporations that lease public hospitals or other public health
656 care facilities.—The records of a private corporation that
657 leases a public hospital or other public health care facility
658 are confidential and exempt from the provisions of s. 119.07(1)
659 and s. 24(a), Art. I of the State Constitution, and the meetings
660 of the governing board of a private corporation are exempt from
661 s. 286.011 and s. 24(b), Art. I of the State Constitution when
662 the public lessor complies with the public finance
663 accountability provisions of s. 155.40(5) with respect to the
664 transfer of any public funds to the private lessee and when the
665 private lessee meets at least three of the five following
666 criteria:
667 (2) The public lessor and the private lessee do not
668 commingle any of their funds in any account maintained by either
669 of them, other than the payment of the rent and administrative
670 fees or the transfer of funds pursuant to s. 155.40 subsection
671 (2).
672 Section 16. Section 395.3037, Florida Statutes, is
673 repealed.
674 Section 17. Paragraph (e) of subsection (2) of section
675 395.602, Florida Statutes, is amended to read:
676 395.602 Rural hospitals.—
677 (2) DEFINITIONS.—As used in this part:
678 (e) “Rural hospital” means an acute care hospital licensed
679 under this chapter, having 100 or fewer licensed beds and an
680 emergency room, which is:
681 1. The sole provider within a county with a population
682 density of no greater than 100 persons per square mile;
683 2. An acute care hospital, in a county with a population
684 density of no greater than 100 persons per square mile, which is
685 at least 30 minutes of travel time, on normally traveled roads
686 under normal traffic conditions, from any other acute care
687 hospital within the same county;
688 3. A hospital supported by a tax district or subdistrict
689 whose boundaries encompass a population of 100 persons or fewer
690 per square mile;
691 4. A hospital in a constitutional charter county with a
692 population of over 1 million persons that has imposed a local
693 option health service tax pursuant to law and in an area that
694 was directly impacted by a catastrophic event on August 24,
695 1992, for which the Governor of Florida declared a state of
696 emergency pursuant to chapter 125, and has 120 beds or less that
697 serves an agricultural community with an emergency room
698 utilization of no less than 20,000 visits and a Medicaid
699 inpatient utilization rate greater than 15 percent;
700 4.5. A hospital with a service area that has a population
701 of 100 persons or fewer per square mile. As used in this
702 subparagraph, the term “service area” means the fewest number of
703 zip codes that account for 75 percent of the hospital’s
704 discharges for the most recent 5-year period, based on
705 information available from the hospital inpatient discharge
706 database in the Florida Center for Health Information and Policy
707 Analysis at the Agency for Health Care Administration; or
708 5.6. A hospital designated as a critical access hospital,
709 as defined in s. 408.07(15).
710
711 Population densities used in this paragraph must be based upon
712 the most recently completed United States census. A hospital
713 that received funds under s. 409.9116 for a quarter beginning no
714 later than July 1, 2002, is deemed to have been and shall
715 continue to be a rural hospital from that date through June 30,
716 2015, if the hospital continues to have 100 or fewer licensed
717 beds and an emergency room, or meets the criteria of
718 subparagraph 4. An acute care hospital that has not previously
719 been designated as a rural hospital and that meets the criteria
720 of this paragraph shall be granted such designation upon
721 application, including supporting documentation to the Agency
722 for Health Care Administration.
723 Section 18. Subsections (8) and (16) of section 400.021,
724 Florida Statutes, are amended to read:
725 400.021 Definitions.—When used in this part, unless the
726 context otherwise requires, the term:
727 (8) “Geriatric outpatient clinic” means a site for
728 providing outpatient health care to persons 60 years of age or
729 older, which is staffed by a registered nurse or a physician
730 assistant, or by a licensed practical nurse who is under the
731 direct supervision of a registered nurse, an advanced registered
732 nurse practitioner, a physician assistant, or a physician.
733 (16) “Resident care plan” means a written plan developed,
734 maintained, and reviewed not less than quarterly by a registered
735 nurse, with participation from other facility staff and the
736 resident or his or her designee or legal representative, which
737 includes a comprehensive assessment of the needs of an
738 individual resident; the type and frequency of services required
739 to provide the necessary care for the resident to attain or
740 maintain the highest practicable physical, mental, and
741 psychosocial well-being; a listing of services provided within
742 or outside the facility to meet those needs; and an explanation
743 of service goals. The resident care plan must be signed by the
744 director of nursing or another registered nurse employed by the
745 facility to whom institutional responsibilities have been
746 delegated and by the resident, the resident’s designee, or the
747 resident’s legal representative. The facility may not use an
748 agency or temporary registered nurse to satisfy the foregoing
749 requirement and must document the institutional responsibilities
750 that have been delegated to the registered nurse.
751 Section 19. Subsection (1) of section 400.275, Florida
752 Statutes, is amended to read:
753 400.275 Agency duties.—
754 (1) The agency shall ensure that each newly hired nursing
755 home surveyor, as a part of basic training, is assigned full
756 time to a licensed nursing home for at least 2 days within a 7
757 day period to observe facility operations outside of the survey
758 process before the surveyor begins survey responsibilities. Such
759 observations may not be the sole basis of a deficiency citation
760 against the facility. The agency may not assign an individual to
761 be a member of a survey team for purposes of a survey,
762 evaluation, or consultation visit at a nursing home facility in
763 which the surveyor was an employee within the preceding 2 5
764 years.
765 Section 20. Subsection (6) of section 400.474, Florida
766 Statutes, is amended, present subsection (7) is redesignated as
767 subsection (8), and a new subsection (7) is added to that
768 section, to read:
769 400.474 Administrative penalties.—
770 (6) The agency may deny, revoke, or suspend the license of
771 a home health agency and shall impose a fine of $5,000 against a
772 home health agency that:
773 (a) Gives remuneration for staffing services to:
774 1. Another home health agency with which it has formal or
775 informal patient-referral transactions or arrangements; or
776 2. A health services pool with which it has formal or
777 informal patient-referral transactions or arrangements,
778
779 unless the home health agency has activated its comprehensive
780 emergency management plan in accordance with s. 400.492. This
781 paragraph does not apply to a Medicare-certified home health
782 agency that provides fair market value remuneration for staffing
783 services to a non-Medicare-certified home health agency that is
784 part of a continuing care facility licensed under chapter 651
785 for providing services to its own residents if each resident
786 receiving home health services pursuant to this arrangement
787 attests in writing that he or she made a decision without
788 influence from staff of the facility to select, from a list of
789 Medicare-certified home health agencies provided by the
790 facility, that Medicare-certified home health agency to provide
791 the services.
792 (b) Provides services to residents in an assisted living
793 facility for which the home health agency does not receive fair
794 market value remuneration.
795 (c) Provides staffing to an assisted living facility for
796 which the home health agency does not receive fair market value
797 remuneration.
798 (d) Fails to provide the agency, upon request, with copies
799 of all contracts with assisted living facilities which were
800 executed within 5 years before the request.
801 (e) Gives remuneration to a case manager, discharge
802 planner, facility-based staff member, or third-party vendor who
803 is involved in the discharge planning process of a facility
804 licensed under chapter 395, chapter 429, or this chapter from
805 whom the home health agency receives referrals.
806 (f) Fails to submit to the agency, within 15 days after the
807 end of each calendar quarter, a written report that includes the
808 following data based on data as it existed on the last day of
809 the quarter:
810 1. The number of insulin-dependent diabetic patients
811 receiving insulin-injection services from the home health
812 agency;
813 2. The number of patients receiving both home health
814 services from the home health agency and hospice services;
815 3. The number of patients receiving home health services
816 from that home health agency; and
817 4. The names and license numbers of nurses whose primary
818 job responsibility is to provide home health services to
819 patients and who received remuneration from the home health
820 agency in excess of $25,000 during the calendar quarter.
821 (f)(g) Gives cash, or its equivalent, to a Medicare or
822 Medicaid beneficiary.
823 (g)(h) Has more than one medical director contract in
824 effect at one time or more than one medical director contract
825 and one contract with a physician-specialist whose services are
826 mandated for the home health agency in order to qualify to
827 participate in a federal or state health care program at one
828 time.
829 (h)(i) Gives remuneration to a physician without a medical
830 director contract being in effect. The contract must:
831 1. Be in writing and signed by both parties;
832 2. Provide for remuneration that is at fair market value
833 for an hourly rate, which must be supported by invoices
834 submitted by the medical director describing the work performed,
835 the dates on which that work was performed, and the duration of
836 that work; and
837 3. Be for a term of at least 1 year.
838
839 The hourly rate specified in the contract may not be increased
840 during the term of the contract. The home health agency may not
841 execute a subsequent contract with that physician which has an
842 increased hourly rate and covers any portion of the term that
843 was in the original contract.
844 (i)(j) Gives remuneration to:
845 1. A physician, and the home health agency is in violation
846 of paragraph (g) (h) or paragraph (h) (i);
847 2. A member of the physician’s office staff; or
848 3. An immediate family member of the physician,
849
850 if the home health agency has received a patient referral in the
851 preceding 12 months from that physician or physician’s office
852 staff.
853 (j)(k) Fails to provide to the agency, upon request, copies
854 of all contracts with a medical director which were executed
855 within 5 years before the request.
856 (k)(l) Demonstrates a pattern of billing the Medicaid
857 program for services to Medicaid recipients which are medically
858 unnecessary as determined by a final order. A pattern may be
859 demonstrated by a showing of at least two such medically
860 unnecessary services within one Medicaid program integrity audit
861 period.
862
863 Nothing in paragraph (e) or paragraph (i) (j) shall be
864 interpreted as applying to or precluding any discount,
865 compensation, waiver of payment, or payment practice permitted
866 by 42 U.S.C. s. 1320a-7(b) or regulations adopted thereunder,
867 including 42 C.F.R. s. 1001.952 or s. 1395nn or regulations
868 adopted thereunder.
869 (7) Each home health agency shall submit to the agency,
870 within 15 days after the end of each calendar quarter, a written
871 report that includes the following data as it existed on the
872 last day of the quarter:
873 (a) The number of insulin-dependent diabetic patients
874 receiving insulin-injection services from the home health
875 agency.
876 (b) The number of patients receiving home health services
877 from the home health agency who are also receiving hospice
878 services.
879 (c) The number of patients receiving home health services
880 from the home health agency.
881 (d) The names and license numbers of nurses whose primary
882 job responsibility is to provide home health services to
883 patients and who received remuneration from the home health
884 agency in excess of $25,000 during the calendar quarter.
885 (e) The number of physicians who were paid by the home
886 health agency for professional services of any kind during the
887 calendar quarter, the amount paid to each physician, and the
888 number of hours each physician spent performing those services.
889
890 If the quarterly report is not received by the agency on or
891 before the deadline, the agency shall impose a fine in the
892 amount of $200 for each day that the report is late, which may
893 not exceed $5,000 per quarter.
894 Section 21. Section 400.484, Florida Statutes, is amended
895 to read:
896 400.484 Right of inspection; violations deficiencies;
897 fines.—
898 (1) In addition to the requirements of s. 408.811, the
899 agency may make such inspections and investigations as are
900 necessary in order to determine the state of compliance with
901 this part, part II of chapter 408, and applicable rules.
902 (2) The agency shall impose fines for various classes of
903 violations deficiencies in accordance with the following
904 schedule:
905 (a) A class I violation is defined in s. 408.813 deficiency
906 is any act, omission, or practice that results in a patient’s
907 death, disablement, or permanent injury, or places a patient at
908 imminent risk of death, disablement, or permanent injury. Upon
909 finding a class I violation deficiency, the agency shall impose
910 an administrative fine in the amount of $15,000 for each
911 occurrence and each day that the violation deficiency exists.
912 (b) A class II violation is defined in s. 408.813
913 deficiency is any act, omission, or practice that has a direct
914 adverse effect on the health, safety, or security of a patient.
915 Upon finding a class II violation deficiency, the agency shall
916 impose an administrative fine in the amount of $5,000 for each
917 occurrence and each day that the violation deficiency exists.
918 (c) A class III violation is defined in s. 408.813
919 deficiency is any act, omission, or practice that has an
920 indirect, adverse effect on the health, safety, or security of a
921 patient. Upon finding an uncorrected or repeated class III
922 violation deficiency, the agency shall impose an administrative
923 fine not to exceed $1,000 for each occurrence and each day that
924 the uncorrected or repeated violation deficiency exists.
925 (d) A class IV violation is defined in s. 408.813
926 deficiency is any act, omission, or practice related to required
927 reports, forms, or documents which does not have the potential
928 of negatively affecting patients. These violations are of a type
929 that the agency determines do not threaten the health, safety,
930 or security of patients. Upon finding an uncorrected or repeated
931 class IV violation deficiency, the agency shall impose an
932 administrative fine not to exceed $500 for each occurrence and
933 each day that the uncorrected or repeated violation deficiency
934 exists.
935 (3) In addition to any other penalties imposed pursuant to
936 this section or part, the agency may assess costs related to an
937 investigation that results in a successful prosecution,
938 excluding costs associated with an attorney’s time.
939 Section 22. For the purpose of incorporating the amendment
940 made by this act to section 400.509, Florida Statutes, in a
941 reference thereto, paragraph (a) of subsection (6) of section
942 400.506 is reenacted, present subsection (17) of that section is
943 renumbered as subsection (18), and a new subsection (17) is
944 added to that section, to read:
945 400.506 Licensure of nurse registries; requirements;
946 penalties.—
947 (6)(a) A nurse registry may refer for contract in private
948 residences registered nurses and licensed practical nurses
949 registered and licensed under part I of chapter 464, certified
950 nursing assistants certified under part II of chapter 464, home
951 health aides who present documented proof of successful
952 completion of the training required by rule of the agency, and
953 companions or homemakers for the purposes of providing those
954 services authorized under s. 400.509(1). A licensed nurse
955 registry shall ensure that each certified nursing assistant
956 referred for contract by the nurse registry and each home health
957 aide referred for contract by the nurse registry is adequately
958 trained to perform the tasks of a home health aide in the home
959 setting. Each person referred by a nurse registry must provide
960 current documentation that he or she is free from communicable
961 diseases.
962 (17) An administrator may manage only one nurse registry,
963 except that an administrator may manage up to five registries if
964 all five registries have identical controlling interests as
965 defined in s. 408.803 and are located within one agency
966 geographic service area or within an immediately contiguous
967 county. An administrator shall designate, in writing, for each
968 licensed entity, a qualified alternate administrator to serve
969 during the administrator’s absence.
970 Section 23. Subsection (1) of section 400.509, Florida
971 Statutes, is amended to read:
972 400.509 Registration of particular service providers exempt
973 from licensure; certificate of registration; regulation of
974 registrants.—
975 (1) Any organization that provides companion services or
976 homemaker services and does not provide a home health service to
977 a person is exempt from licensure under this part. However, any
978 organization that provides companion services or homemaker
979 services must register with the agency. An organization under
980 contract with the Agency for Persons with Disabilities which
981 provides companion services only for persons with a
982 developmental disability, as defined in s. 393.063, is exempt
983 from registration.
984 Section 24. Subsection (3) of section 400.601, Florida
985 Statutes, is amended to read:
986 400.601 Definitions.—As used in this part, the term:
987 (3) “Hospice” means a centrally administered corporation or
988 a limited liability company that provides providing a continuum
989 of palliative and supportive care for the terminally ill patient
990 and his or her family.
991 Section 25. Paragraph (i) of subsection (1) and subsection
992 (4) of section 400.606, Florida Statutes, are amended to read:
993 400.606 License; application; renewal; conditional license
994 or permit; certificate of need.—
995 (1) In addition to the requirements of part II of chapter
996 408, the initial application and change of ownership application
997 must be accompanied by a plan for the delivery of home,
998 residential, and homelike inpatient hospice services to
999 terminally ill persons and their families. Such plan must
1000 contain, but need not be limited to:
1001 (i) The projected annual operating cost of the hospice.
1002
1003 If the applicant is an existing licensed health care provider,
1004 the application must be accompanied by a copy of the most recent
1005 profit-loss statement and, if applicable, the most recent
1006 licensure inspection report.
1007 (4) A freestanding hospice facility that is primarily
1008 engaged in providing inpatient and related services and that is
1009 not otherwise licensed as a health care facility shall be
1010 required to obtain a certificate of need. However, a
1011 freestanding hospice facility that has with six or fewer beds is
1012 shall not be required to comply with institutional standards
1013 such as, but not limited to, standards requiring sprinkler
1014 systems, emergency electrical systems, or special lavatory
1015 devices.
1016 Section 26. Section 400.915, Florida Statutes, is amended
1017 to read:
1018 400.915 Construction and renovation; requirements.—The
1019 requirements for the construction or renovation of a PPEC center
1020 shall comply with:
1021 (1) The provisions of chapter 553, which pertain to
1022 building construction standards, including plumbing, electrical
1023 code, glass, manufactured buildings, accessibility for the
1024 physically disabled;
1025 (2) The provisions of s. 633.022 and applicable rules
1026 pertaining to physical minimum standards for nonresidential
1027 child care physical facilities in rule 10M-12.003, Florida
1028 Administrative Code, Child Care Standards; and
1029 (3) The standards or rules adopted pursuant to this part
1030 and part II of chapter 408.
1031 Section 27. Section 400.931, Florida Statutes, is amended
1032 to read:
1033 400.931 Application for license; fee; provisional license;
1034 temporary permit.—
1035 (1) In addition to the requirements of part II of chapter
1036 408, the applicant must file with the application satisfactory
1037 proof that the home medical equipment provider is in compliance
1038 with this part and applicable rules, including:
1039 (a) A report, by category, of the equipment to be provided,
1040 indicating those offered either directly by the applicant or
1041 through contractual arrangements with existing providers.
1042 Categories of equipment include:
1043 1. Respiratory modalities.
1044 2. Ambulation aids.
1045 3. Mobility aids.
1046 4. Sickroom setup.
1047 5. Disposables.
1048 (b) A report, by category, of the services to be provided,
1049 indicating those offered either directly by the applicant or
1050 through contractual arrangements with existing providers.
1051 Categories of services include:
1052 1. Intake.
1053 2. Equipment selection.
1054 3. Delivery.
1055 4. Setup and installation.
1056 5. Patient training.
1057 6. Ongoing service and maintenance.
1058 7. Retrieval.
1059 (c) A listing of those with whom the applicant contracts,
1060 both the providers the applicant uses to provide equipment or
1061 services to its consumers and the providers for whom the
1062 applicant provides services or equipment.
1063 (2) An applicant for initial licensure, change of
1064 ownership, or license renewal to operate a licensed home medical
1065 equipment provider at a location outside the state must submit
1066 documentation of accreditation or an application for
1067 accreditation from an accrediting organization that is
1068 recognized by the agency. An applicant that has applied for
1069 accreditation must provide proof of accreditation that is not
1070 conditional or provisional within 120 days after the date the
1071 agency receives the application for licensure or the application
1072 shall be withdrawn from further consideration. Such
1073 accreditation must be maintained by the home medical equipment
1074 provider in order to maintain licensure. As an alternative to
1075 submitting proof of financial ability to operate as required in
1076 s. 408.810(8), the applicant may submit a $50,000 surety bond to
1077 the agency.
1078 (3) As specified in part II of chapter 408, the home
1079 medical equipment provider must also obtain and maintain
1080 professional and commercial liability insurance. Proof of
1081 liability insurance, as defined in s. 624.605, must be submitted
1082 with the application. The agency shall set the required amounts
1083 of liability insurance by rule, but the required amount must not
1084 be less than $250,000 per claim. In the case of contracted
1085 services, it is required that the contractor have liability
1086 insurance not less than $250,000 per claim.
1087 (4) When a change of the general manager of a home medical
1088 equipment provider occurs, the licensee must notify the agency
1089 of the change within 45 days.
1090 (5) In accordance with s. 408.805, an applicant or a
1091 licensee shall pay a fee for each license application submitted
1092 under this part, part II of chapter 408, and applicable rules.
1093 The amount of the fee shall be established by rule and may not
1094 exceed $300 per biennium. The agency shall set the fees in an
1095 amount that is sufficient to cover its costs in carrying out its
1096 responsibilities under this part. However, state, county, or
1097 municipal governments applying for licenses under this part are
1098 exempt from the payment of license fees.
1099 (6) An applicant for initial licensure, renewal, or change
1100 of ownership shall also pay an inspection fee not to exceed
1101 $400, which shall be paid by all applicants except those not
1102 subject to licensure inspection by the agency as described in s.
1103 400.933.
1104 Section 28. Section 400.967, Florida Statutes, is amended
1105 to read:
1106 400.967 Rules and classification of violations
1107 deficiencies.—
1108 (1) It is the intent of the Legislature that rules adopted
1109 and enforced under this part and part II of chapter 408 include
1110 criteria by which a reasonable and consistent quality of
1111 resident care may be ensured, the results of such resident care
1112 can be demonstrated, and safe and sanitary facilities can be
1113 provided.
1114 (2) Pursuant to the intention of the Legislature, the
1115 agency, in consultation with the Agency for Persons with
1116 Disabilities and the Department of Elderly Affairs, shall adopt
1117 and enforce rules to administer this part and part II of chapter
1118 408, which shall include reasonable and fair criteria governing:
1119 (a) The location and construction of the facility;
1120 including fire and life safety, plumbing, heating, cooling,
1121 lighting, ventilation, and other housing conditions that ensure
1122 the health, safety, and comfort of residents. The agency shall
1123 establish standards for facilities and equipment to increase the
1124 extent to which new facilities and a new wing or floor added to
1125 an existing facility after July 1, 2000, are structurally
1126 capable of serving as shelters only for residents, staff, and
1127 families of residents and staff, and equipped to be self
1128 supporting during and immediately following disasters. The
1129 agency shall update or revise the criteria as the need arises.
1130 All facilities must comply with those lifesafety code
1131 requirements and building code standards applicable at the time
1132 of approval of their construction plans. The agency may require
1133 alterations to a building if it determines that an existing
1134 condition constitutes a distinct hazard to life, health, or
1135 safety. The agency shall adopt fair and reasonable rules setting
1136 forth conditions under which existing facilities undergoing
1137 additions, alterations, conversions, renovations, or repairs are
1138 required to comply with the most recent updated or revised
1139 standards.
1140 (b) The number and qualifications of all personnel,
1141 including management, medical nursing, and other personnel,
1142 having responsibility for any part of the care given to
1143 residents.
1144 (c) All sanitary conditions within the facility and its
1145 surroundings, including water supply, sewage disposal, food
1146 handling, and general hygiene, which will ensure the health and
1147 comfort of residents.
1148 (d) The equipment essential to the health and welfare of
1149 the residents.
1150 (e) A uniform accounting system.
1151 (f) The care, treatment, and maintenance of residents and
1152 measurement of the quality and adequacy thereof.
1153 (g) The preparation and annual update of a comprehensive
1154 emergency management plan. The agency shall adopt rules
1155 establishing minimum criteria for the plan after consultation
1156 with the Division of Emergency Management. At a minimum, the
1157 rules must provide for plan components that address emergency
1158 evacuation transportation; adequate sheltering arrangements;
1159 postdisaster activities, including emergency power, food, and
1160 water; postdisaster transportation; supplies; staffing;
1161 emergency equipment; individual identification of residents and
1162 transfer of records; and responding to family inquiries. The
1163 comprehensive emergency management plan is subject to review and
1164 approval by the local emergency management agency. During its
1165 review, the local emergency management agency shall ensure that
1166 the following agencies, at a minimum, are given the opportunity
1167 to review the plan: the Department of Elderly Affairs, the
1168 Agency for Persons with Disabilities, the Agency for Health Care
1169 Administration, and the Division of Emergency Management. Also,
1170 appropriate volunteer organizations must be given the
1171 opportunity to review the plan. The local emergency management
1172 agency shall complete its review within 60 days and either
1173 approve the plan or advise the facility of necessary revisions.
1174 (h) The use of restraint and seclusion. Such rules must be
1175 consistent with recognized best practices; prohibit inherently
1176 dangerous restraint or seclusion procedures; establish
1177 limitations on the use and duration of restraint and seclusion;
1178 establish measures to ensure the safety of clients and staff
1179 during an incident of restraint or seclusion; establish
1180 procedures for staff to follow before, during, and after
1181 incidents of restraint or seclusion, including individualized
1182 plans for the use of restraints or seclusion in emergency
1183 situations; establish professional qualifications of and
1184 training for staff who may order or be engaged in the use of
1185 restraint or seclusion; establish requirements for facility data
1186 collection and reporting relating to the use of restraint and
1187 seclusion; and establish procedures relating to the
1188 documentation of the use of restraint or seclusion in the
1189 client’s facility or program record.
1190 (3) The agency shall adopt rules to provide that, when the
1191 criteria established under this part and part II of chapter 408
1192 are not met, such violations deficiencies shall be classified
1193 according to the nature of the violation deficiency. The agency
1194 shall indicate the classification on the face of the notice of
1195 violation deficiencies as follows:
1196 (a) A class I violation is defined in s. 408.813
1197 deficiencies are those which the agency determines present an
1198 imminent danger to the residents or guests of the facility or a
1199 substantial probability that death or serious physical harm
1200 would result therefrom. The condition or practice constituting a
1201 class I violation must be abated or eliminated immediately,
1202 unless a fixed period of time, as determined by the agency, is
1203 required for correction. A class I violation deficiency is
1204 subject to a civil penalty in an amount not less than $5,000 and
1205 not exceeding $10,000 for each violation deficiency. A fine may
1206 be levied notwithstanding the correction of the violation
1207 deficiency.
1208 (b) A class II violation is defined in s. 408.813
1209 deficiencies are those which the agency determines have a direct
1210 or immediate relationship to the health, safety, or security of
1211 the facility residents, other than class I deficiencies. A class
1212 II violation deficiency is subject to a civil penalty in an
1213 amount not less than $1,000 and not exceeding $5,000 for each
1214 violation deficiency. A citation for a class II violation
1215 deficiency shall specify the time within which the violation
1216 deficiency must be corrected. If a class II violation deficiency
1217 is corrected within the time specified, no civil penalty shall
1218 be imposed, unless it is a repeated offense.
1219 (c) A class III violation is defined in s. 408.813
1220 deficiencies are those which the agency determines to have an
1221 indirect or potential relationship to the health, safety, or
1222 security of the facility residents, other than class I or class
1223 II deficiencies. A class III violation deficiency is subject to
1224 a civil penalty of not less than $500 and not exceeding $1,000
1225 for each violation deficiency. A citation for a class III
1226 violation deficiency shall specify the time within which the
1227 violation deficiency must be corrected. If a class III violation
1228 deficiency is corrected within the time specified, no civil
1229 penalty shall be imposed, unless it is a repeated offense.
1230 (d) A class IV violation is defined in s. 408.813. Upon
1231 finding an uncorrected or repeated class IV violation, the
1232 agency shall impose an administrative fine not to exceed $500
1233 for each occurrence and each day that the uncorrected or
1234 repeated violation exists.
1235 (4) The agency shall approve or disapprove the plans and
1236 specifications within 60 days after receipt of the final plans
1237 and specifications. The agency may be granted one 15-day
1238 extension for the review period, if the secretary of the agency
1239 so approves. If the agency fails to act within the specified
1240 time, it is deemed to have approved the plans and
1241 specifications. When the agency disapproves plans and
1242 specifications, it must set forth in writing the reasons for
1243 disapproval. Conferences and consultations may be provided as
1244 necessary.
1245 (5) The agency may charge an initial fee of $2,000 for
1246 review of plans and construction on all projects, no part of
1247 which is refundable. The agency may also collect a fee, not to
1248 exceed 1 percent of the estimated construction cost or the
1249 actual cost of review, whichever is less, for the portion of the
1250 review which encompasses initial review through the initial
1251 revised construction document review. The agency may collect its
1252 actual costs on all subsequent portions of the review and
1253 construction inspections. Initial fee payment must accompany the
1254 initial submission of plans and specifications. Any subsequent
1255 payment that is due is payable upon receipt of the invoice from
1256 the agency. Notwithstanding any other provision of law, all
1257 money received by the agency under this section shall be deemed
1258 to be trust funds, to be held and applied solely for the
1259 operations required under this section.
1260 Section 29. Subsections (4) and (7) of section 400.9905,
1261 Florida Statutes, are amended to read:
1262 400.9905 Definitions.—
1263 (4) “Clinic” means an entity at which health care services
1264 are provided to individuals and which tenders charges for
1265 reimbursement for such services, including a mobile clinic and a
1266 portable health service or equipment provider. For purposes of
1267 this part, the term does not include and the licensure
1268 requirements of this part do not apply to:
1269 (a) Entities licensed or registered by the state under
1270 chapter 395; or entities licensed or registered by the state and
1271 providing only health care services within the scope of services
1272 authorized under their respective licenses granted under ss.
1273 383.30-383.335, chapter 390, chapter 394, chapter 397, this
1274 chapter except part X, chapter 429, chapter 463, chapter 465,
1275 chapter 466, chapter 478, part I of chapter 483, chapter 484, or
1276 chapter 651; end-stage renal disease providers authorized under
1277 42 C.F.R. part 405, subpart U; or providers certified under 42
1278 C.F.R. part 485, subpart B or subpart H; or any entity that
1279 provides neonatal or pediatric hospital-based health care
1280 services or other health care services by licensed practitioners
1281 solely within a hospital licensed under chapter 395.
1282 (b) Entities that own, directly or indirectly, entities
1283 licensed or registered by the state pursuant to chapter 395; or
1284 entities that own, directly or indirectly, entities licensed or
1285 registered by the state and providing only health care services
1286 within the scope of services authorized pursuant to their
1287 respective licenses granted under ss. 383.30-383.335, chapter
1288 390, chapter 394, chapter 397, this chapter except part X,
1289 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
1290 part I of chapter 483, chapter 484, chapter 651; end-stage renal
1291 disease providers authorized under 42 C.F.R. part 405, subpart
1292 U; or providers certified under 42 C.F.R. part 485, subpart B or
1293 subpart H; or any entity that provides neonatal or pediatric
1294 hospital-based health care services by licensed practitioners
1295 solely within a hospital licensed under chapter 395.
1296 (c) Entities that are owned, directly or indirectly, by an
1297 entity licensed or registered by the state pursuant to chapter
1298 395; or entities that are owned, directly or indirectly, by an
1299 entity licensed or registered by the state and providing only
1300 health care services within the scope of services authorized
1301 pursuant to their respective licenses granted under ss. 383.30
1302 383.335, chapter 390, chapter 394, chapter 397, this chapter
1303 except part X, chapter 429, chapter 463, chapter 465, chapter
1304 466, chapter 478, part I of chapter 483, chapter 484, or chapter
1305 651; end-stage renal disease providers authorized under 42
1306 C.F.R. part 405, subpart U; or providers certified under 42
1307 C.F.R. part 485, subpart B or subpart H; or any entity that
1308 provides neonatal or pediatric hospital-based health care
1309 services by licensed practitioners solely within a hospital
1310 under chapter 395.
1311 (d) Entities that are under common ownership, directly or
1312 indirectly, with an entity licensed or registered by the state
1313 pursuant to chapter 395; or entities that are under common
1314 ownership, directly or indirectly, with an entity licensed or
1315 registered by the state and providing only health care services
1316 within the scope of services authorized pursuant to their
1317 respective licenses granted under ss. 383.30-383.335, chapter
1318 390, chapter 394, chapter 397, this chapter except part X,
1319 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
1320 part I of chapter 483, chapter 484, or chapter 651; end-stage
1321 renal disease providers authorized under 42 C.F.R. part 405,
1322 subpart U; or providers certified under 42 C.F.R. part 485,
1323 subpart B or subpart H; or any entity that provides neonatal or
1324 pediatric hospital-based health care services by licensed
1325 practitioners solely within a hospital licensed under chapter
1326 395.
1327 (e) An entity that is exempt from federal taxation under 26
1328 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan
1329 under 26 U.S.C. s. 409 that has a board of trustees not less
1330 than two-thirds of which are Florida-licensed health care
1331 practitioners and provides only physical therapy services under
1332 physician orders, any community college or university clinic,
1333 and any entity owned or operated by the federal or state
1334 government, including agencies, subdivisions, or municipalities
1335 thereof.
1336 (f) A sole proprietorship, group practice, partnership, or
1337 corporation that provides health care services by physicians
1338 covered by s. 627.419, that is directly supervised by one or
1339 more of such physicians, and that is wholly owned by one or more
1340 of those physicians or by a physician and the spouse, parent,
1341 child, or sibling of that physician.
1342 (g) A sole proprietorship, group practice, partnership, or
1343 corporation that provides health care services by licensed
1344 health care practitioners under chapter 457, chapter 458,
1345 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
1346 chapter 466, chapter 467, chapter 480, chapter 484, chapter 486,
1347 chapter 490, chapter 491, or part I, part III, part X, part
1348 XIII, or part XIV of chapter 468, or s. 464.012, which are
1349 wholly owned by one or more licensed health care practitioners,
1350 or the licensed health care practitioners set forth in this
1351 paragraph and the spouse, parent, child, or sibling of a
1352 licensed health care practitioner, so long as one of the owners
1353 who is a licensed health care practitioner is supervising the
1354 business activities and is legally responsible for the entity’s
1355 compliance with all federal and state laws. However, a health
1356 care practitioner may not supervise services beyond the scope of
1357 the practitioner’s license, except that, for the purposes of
1358 this part, a clinic owned by a licensee in s. 456.053(3)(b) that
1359 provides only services authorized pursuant to s. 456.053(3)(b)
1360 may be supervised by a licensee specified in s. 456.053(3)(b).
1361 (h) Clinical facilities affiliated with an accredited
1362 medical school at which training is provided for medical
1363 students, residents, or fellows.
1364 (i) Entities that provide only oncology or radiation
1365 therapy services by physicians licensed under chapter 458 or
1366 chapter 459 or entities that provide oncology or radiation
1367 therapy services by physicians licensed under chapter 458 or
1368 chapter 459 which are owned by a corporation whose shares are
1369 publicly traded on a recognized stock exchange.
1370 (j) Clinical facilities affiliated with a college of
1371 chiropractic accredited by the Council on Chiropractic Education
1372 at which training is provided for chiropractic students.
1373 (k) Entities that provide licensed practitioners to staff
1374 emergency departments or to deliver anesthesia services in
1375 facilities licensed under chapter 395 and that derive at least
1376 90 percent of their gross annual revenues from the provision of
1377 such services. Entities claiming an exemption from licensure
1378 under this paragraph must provide documentation demonstrating
1379 compliance.
1380 (l) Orthotic, or prosthetic, pediatric cardiology, or
1381 perinatology clinical facilities or anesthesia clinical
1382 facilities that are not otherwise exempt under paragraph (a) or
1383 paragraph (k) and that are a publicly traded corporation or that
1384 are wholly owned, directly or indirectly, by a publicly traded
1385 corporation. As used in this paragraph, a publicly traded
1386 corporation is a corporation that issues securities traded on an
1387 exchange registered with the United States Securities and
1388 Exchange Commission as a national securities exchange.
1389 (m) Entities that are owned or controlled, directly or
1390 indirectly, by a publicly traded entity with $100 million or
1391 more, in the aggregate, in total annual revenues derived from
1392 providing health care services by licensed health care
1393 practitioners that are employed or contracted by an entity
1394 described in this paragraph.
1395 (n) Entities that are owned by a corporation that has $250
1396 million or more in total annual sales of health care services
1397 provided by licensed health care practitioners if one or more of
1398 the owners of the entity is a health care practitioner who is
1399 licensed in this state, is responsible for supervising the
1400 business activities of the entity, and is legally responsible
1401 for the entity’s compliance with state law for purposes of this
1402 section.
1403 (o) Entities that employ 50 or more health care
1404 practitioners who are licensed under chapter 458 or chapter 459
1405 if the billing for medical services is under a single corporate
1406 tax identification number. The application for exemption under
1407 this paragraph must contain information that includes the name,
1408 residence address, business address, and telephone number of the
1409 entity that owns the practice; a complete list of the names and
1410 contact information of all the officers and directors of the
1411 entity; the name, residence address, business address, and
1412 medical license number of each health care practitioner who is
1413 licensed to practice in this state and employed by the entity;
1414 the corporate tax identification number of the entity seeking an
1415 exemption; a listing of health care services to be provided by
1416 the entity at the health care clinics owned or operated by the
1417 entity; and a certified statement prepared by an independent
1418 certified public accountant which states that the entity and the
1419 health care clinics owned or operated by the entity have not
1420 received payment for health care services under insurance
1421 coverage for personal injury protection for the preceding year.
1422 If the agency determines that an entity that is exempt under
1423 this paragraph has received payments for medical services for
1424 insurance coverage for personal injury protection, the agency
1425 may deny or revoke the exemption from licensure under this
1426 paragraph.
1427 (7) “Portable health service or equipment provider” means
1428 an entity that contracts with or employs persons to provide
1429 portable health services at or equipment to multiple locations
1430 performing treatment or diagnostic testing of individuals, that
1431 bills third-party payors for those services, and that otherwise
1432 meets the definition of a clinic in subsection (4).
1433 Section 30. Paragraph (b) of subsection (1) and subsection
1434 (4) of section 400.991, Florida Statutes, are amended to read:
1435 400.991 License requirements; background screenings;
1436 prohibitions.—
1437 (1)
1438 (b) Each mobile clinic must obtain a separate health care
1439 clinic license and must provide to the agency, at least
1440 quarterly, its projected street location to enable the agency to
1441 locate and inspect such clinic. A portable health service or
1442 equipment provider must obtain a health care clinic license for
1443 a single administrative office and is not required to submit
1444 quarterly projected street locations.
1445 (4) In addition to the requirements of part II of chapter
1446 408, the applicant must file with the application satisfactory
1447 proof that the clinic is in compliance with this part and
1448 applicable rules, including:
1449 (a) A listing of services to be provided either directly by
1450 the applicant or through contractual arrangements with existing
1451 providers;
1452 (b) The number and discipline of each professional staff
1453 member to be employed; and
1454 (c) Proof of financial ability to operate as required under
1455 ss. s. 408.810(8) and 408.8065. As an alternative to submitting
1456 proof of financial ability to operate as required under s.
1457 408.810(8), the applicant may file a surety bond of at least
1458 $500,000 which guarantees that the clinic will act in full
1459 conformity with all legal requirements for operating a clinic,
1460 payable to the agency. The agency may adopt rules to specify
1461 related requirements for such surety bond.
1462 Section 31. Paragraph (a) of subsection (2) of section
1463 408.033, Florida Statutes, is amended to read:
1464 408.033 Local and state health planning.—
1465 (2) FUNDING.—
1466 (a) The Legislature intends that the cost of local health
1467 councils be borne by assessments on selected health care
1468 facilities subject to facility licensure by the Agency for
1469 Health Care Administration, including abortion clinics, assisted
1470 living facilities, ambulatory surgical centers, birthing
1471 centers, clinical laboratories except community nonprofit blood
1472 banks and clinical laboratories operated by practitioners for
1473 exclusive use regulated under s. 483.035, home health agencies,
1474 hospices, hospitals, intermediate care facilities for the
1475 developmentally disabled, nursing homes, health care clinics,
1476 and multiphasic testing centers and by assessments on
1477 organizations subject to certification by the agency pursuant to
1478 chapter 641, part III, including health maintenance
1479 organizations and prepaid health clinics. Fees assessed may be
1480 collected prospectively at the time of licensure renewal and
1481 prorated for the licensure period.
1482 Section 32. Subsection (2) of section 408.034, Florida
1483 Statutes, is amended to read:
1484 408.034 Duties and responsibilities of agency; rules.—
1485 (2) In the exercise of its authority to issue licenses to
1486 health care facilities and health service providers, as provided
1487 under chapters 393 and 395 and parts II, and IV, and VIII of
1488 chapter 400, the agency may not issue a license to any health
1489 care facility or health service provider that fails to receive a
1490 certificate of need or an exemption for the licensed facility or
1491 service.
1492 Section 33. Paragraph (d) of subsection (1) of section
1493 408.036, Florida Statutes, is amended to read:
1494 408.036 Projects subject to review; exemptions.—
1495 (1) APPLICABILITY.—Unless exempt under subsection (3), all
1496 health-care-related projects, as described in paragraphs (a)
1497 (g), are subject to review and must file an application for a
1498 certificate of need with the agency. The agency is exclusively
1499 responsible for determining whether a health-care-related
1500 project is subject to review under ss. 408.031-408.045.
1501 (d) The establishment of a hospice or hospice inpatient
1502 facility, except as provided in s. 408.043.
1503 Section 34. Paragraph (c) of subsection (1) of section
1504 408.037, Florida Statutes, is amended to read:
1505 408.037 Application content.—
1506 (1) Except as provided in subsection (2) for a general
1507 hospital, an application for a certificate of need must contain:
1508 (c) An audited financial statement of the applicant or the
1509 applicant’s parent corporation if audited financial statements
1510 of the applicant do not exist. In an application submitted by an
1511 existing health care facility, health maintenance organization,
1512 or hospice, financial condition documentation must include, but
1513 need not be limited to, a balance sheet and a profit-and-loss
1514 statement of the 2 previous fiscal years’ operation.
1515 Section 35. Subsection (2) of section 408.043, Florida
1516 Statutes, is amended to read:
1517 408.043 Special provisions.—
1518 (2) HOSPICES.—When an application is made for a certificate
1519 of need to establish or to expand a hospice, the need for such
1520 hospice shall be determined on the basis of the need for and
1521 availability of hospice services in the community. The formula
1522 on which the certificate of need is based shall discourage
1523 regional monopolies and promote competition. The inpatient
1524 hospice care component of a hospice which is a freestanding
1525 facility, or a part of a facility, which is primarily engaged in
1526 providing inpatient care and related services and is not
1527 licensed as a health care facility shall also be required to
1528 obtain a certificate of need. Provision of hospice care by any
1529 current provider of health care is a significant change in
1530 service and therefore requires a certificate of need for such
1531 services.
1532 Section 36. Paragraph (a) of subsection (1) of section
1533 408.061, Florida Statutes, is amended to read:
1534 408.061 Data collection; uniform systems of financial
1535 reporting; information relating to physician charges;
1536 confidential information; immunity.—
1537 (1) The agency shall require the submission by health care
1538 facilities, health care providers, and health insurers of data
1539 necessary to carry out the agency’s duties. Specifications for
1540 data to be collected under this section shall be developed by
1541 the agency with the assistance of technical advisory panels
1542 including representatives of affected entities, consumers,
1543 purchasers, and such other interested parties as may be
1544 determined by the agency.
1545 (a) Data submitted by health care facilities, including the
1546 facilities as defined in chapter 395, shall include, but are not
1547 limited to: case-mix data, patient admission and discharge data,
1548 hospital emergency department data which shall include the
1549 number of patients treated in the emergency department of a
1550 licensed hospital reported by patient acuity level, data on
1551 hospital-acquired infections as specified by rule, data on
1552 complications as specified by rule, data on readmissions as
1553 specified by rule, with patient and provider-specific
1554 identifiers included, actual charge data by diagnostic groups,
1555 financial data, accounting data, operating expenses, expenses
1556 incurred for rendering services to patients who cannot or do not
1557 pay, interest charges, depreciation expenses based on the
1558 expected useful life of the property and equipment involved, and
1559 demographic data. The agency shall adopt nationally recognized
1560 risk adjustment methodologies or software consistent with the
1561 standards of the Agency for Healthcare Research and Quality and
1562 as selected by the agency for all data submitted as required by
1563 this section. Data may be obtained from documents such as, but
1564 not limited to: leases, contracts, debt instruments, itemized
1565 patient bills, medical record abstracts, and related diagnostic
1566 information. Reported data elements shall be reported
1567 electronically and in accordance with rule 59E-7.012, Florida
1568 Administrative Code. Data submitted shall be certified by the
1569 chief executive officer or an appropriate and duly authorized
1570 representative or employee of the licensed facility that the
1571 information submitted is true and accurate.
1572 Section 37. Subsection (43) of section 408.07, Florida
1573 Statutes, is amended to read:
1574 408.07 Definitions.—As used in this chapter, with the
1575 exception of ss. 408.031-408.045, the term:
1576 (43) “Rural hospital” means an acute care hospital licensed
1577 under chapter 395, having 100 or fewer licensed beds and an
1578 emergency room, and which is:
1579 (a) The sole provider within a county with a population
1580 density of no greater than 100 persons per square mile;
1581 (b) An acute care hospital, in a county with a population
1582 density of no greater than 100 persons per square mile, which is
1583 at least 30 minutes of travel time, on normally traveled roads
1584 under normal traffic conditions, from another acute care
1585 hospital within the same county;
1586 (c) A hospital supported by a tax district or subdistrict
1587 whose boundaries encompass a population of 100 persons or fewer
1588 per square mile;
1589 (d) A hospital with a service area that has a population of
1590 100 persons or fewer per square mile. As used in this paragraph,
1591 the term “service area” means the fewest number of zip codes
1592 that account for 75 percent of the hospital’s discharges for the
1593 most recent 5-year period, based on information available from
1594 the hospital inpatient discharge database in the Florida Center
1595 for Health Information and Policy Analysis at the Agency for
1596 Health Care Administration; or
1597 (e) A critical access hospital.
1598
1599 Population densities used in this subsection must be based upon
1600 the most recently completed United States census. A hospital
1601 that received funds under s. 409.9116 for a quarter beginning no
1602 later than July 1, 2002, is deemed to have been and shall
1603 continue to be a rural hospital from that date through June 30,
1604 2015, if the hospital continues to have 100 or fewer licensed
1605 beds and an emergency room, or meets the criteria of s.
1606 395.602(2)(e)4. An acute care hospital that has not previously
1607 been designated as a rural hospital and that meets the criteria
1608 of this subsection shall be granted such designation upon
1609 application, including supporting documentation, to the Agency
1610 for Health Care Administration.
1611 Section 38. Section 408.10, Florida Statutes, is amended to
1612 read:
1613 408.10 Consumer complaints.—The agency shall:
1614 (1) publish and make available to the public a toll-free
1615 telephone number for the purpose of handling consumer complaints
1616 and shall serve as a liaison between consumer entities and other
1617 private entities and governmental entities for the disposition
1618 of problems identified by consumers of health care.
1619 (2) Be empowered to investigate consumer complaints
1620 relating to problems with health care facilities’ billing
1621 practices and issue reports to be made public in any cases where
1622 the agency determines the health care facility has engaged in
1623 billing practices which are unreasonable and unfair to the
1624 consumer.
1625 Section 39. Effective May 1, 2012, subsection (15) is added
1626 to section 408.7056, Florida Statutes, to read:
1627 408.7056 Subscriber Assistance Program.—
1628 (15) This section applies only to prepaid health clinics
1629 certified under chapter 641, Florida Healthy Kids health plans,
1630 and health plans that meet the requirements of 45 C.F.R.
1631 147.140.
1632 Section 40. Subsection (11) of section 408.802, Florida
1633 Statutes, is repealed.
1634 Section 41. Subsection (3) is added to section 408.804,
1635 Florida Statutes, to read:
1636 408.804 License required; display.—
1637 (3) Any person who knowingly alters, defaces, or falsifies
1638 a license certificate issued by the agency, or causes or
1639 procures any person to commit such an offense, commits a
1640 misdemeanor of the second degree, punishable as provided in s.
1641 775.082 or s. 775.083. Any licensee or provider who displays an
1642 altered, defaced, or falsified license certificate is subject to
1643 the penalties set forth in s. 408.815 and an administrative fine
1644 of $1,000 for each day of illegal display.
1645 Section 42. Paragraph (d) of subsection (2) of section
1646 408.806, Florida Statutes, is amended, and paragraph (e) is
1647 added to that subsection, to read:
1648 408.806 License application process.—
1649 (2)
1650 (d) The agency shall notify the licensee by mail or
1651 electronically at least 90 days before the expiration of a
1652 license that a renewal license is necessary to continue
1653 operation. The licensee’s failure to timely file submit a
1654 renewal application and license application fee with the agency
1655 shall result in a $50 per day late fee charged to the licensee
1656 by the agency; however, the aggregate amount of the late fee may
1657 not exceed 50 percent of the licensure fee or $500, whichever is
1658 less. The agency shall provide a courtesy notice to the licensee
1659 by United States mail, electronically, or by any other manner at
1660 its address of record or mailing address, if provided, at least
1661 90 days before the expiration of a license. This courtesy notice
1662 must inform the licensee of the expiration of the license. If
1663 the agency does not provide the courtesy notice or the licensee
1664 does not receive the courtesy notice, the licensee continues to
1665 be legally obligated to timely file the renewal application and
1666 license application fee with the agency and is not excused from
1667 the payment of a late fee. If an application is received after
1668 the required filing date and exhibits a hand-canceled postmark
1669 obtained from a United States post office dated on or before the
1670 required filing date, no fine will be levied.
1671 (e) The applicant must pay the late fee before a late
1672 application is considered complete and failure to pay the late
1673 fee is considered an omission from the application for licensure
1674 pursuant to paragraph (3)(b).
1675 Section 43. Paragraph (b) of subsection (1) of section
1676 408.8065, Florida Statutes, is amended to read:
1677 408.8065 Additional licensure requirements for home health
1678 agencies, home medical equipment providers, and health care
1679 clinics.—
1680 (1) An applicant for initial licensure, or initial
1681 licensure due to a change of ownership, as a home health agency,
1682 home medical equipment provider, or health care clinic shall:
1683 (b) Submit projected pro forma financial statements,
1684 including a balance sheet, income and expense statement, and a
1685 statement of cash flows for the first 2 years of operation which
1686 provide evidence that the applicant has sufficient assets,
1687 credit, and projected revenues to cover liabilities and
1688 expenses.
1689
1690 All documents required under this subsection must be prepared in
1691 accordance with generally accepted accounting principles and may
1692 be in a compilation form. The financial statements must be
1693 signed by a certified public accountant.
1694 Section 44. Section 408.809, Florida Statutes, is amended
1695 to read:
1696 408.809 Background screening; prohibited offenses.—
1697 (1) Level 2 background screening pursuant to chapter 435
1698 must be conducted through the agency on each of the following
1699 persons, who are considered employees for the purposes of
1700 conducting screening under chapter 435:
1701 (a) The licensee, if an individual.
1702 (b) The administrator or a similarly titled person who is
1703 responsible for the day-to-day operation of the provider.
1704 (c) The financial officer or similarly titled individual
1705 who is responsible for the financial operation of the licensee
1706 or provider.
1707 (d) Any person who is a controlling interest if the agency
1708 has reason to believe that such person has been convicted of any
1709 offense prohibited by s. 435.04. For each controlling interest
1710 who has been convicted of any such offense, the licensee shall
1711 submit to the agency a description and explanation of the
1712 conviction at the time of license application.
1713 (e) Any person, as required by authorizing statutes,
1714 seeking employment with a licensee or provider who is expected
1715 to, or whose responsibilities may require him or her to, provide
1716 personal care or services directly to clients or have access to
1717 client funds, personal property, or living areas; and any
1718 person, as required by authorizing statutes, contracting with a
1719 licensee or provider whose responsibilities require him or her
1720 to provide personal care or personal services directly to
1721 clients. Evidence of contractor screening may be retained by the
1722 contractor’s employer or the licensee.
1723 (2) Every 5 years following his or her licensure,
1724 employment, or entry into a contract in a capacity that under
1725 subsection (1) would require level 2 background screening under
1726 chapter 435, each such person must submit to level 2 background
1727 rescreening as a condition of retaining such license or
1728 continuing in such employment or contractual status. For any
1729 such rescreening, the agency shall request the Department of Law
1730 Enforcement to forward the person’s fingerprints to the Federal
1731 Bureau of Investigation for a national criminal history record
1732 check. If the fingerprints of such a person are not retained by
1733 the Department of Law Enforcement under s. 943.05(2)(g), the
1734 person must file a complete set of fingerprints with the agency
1735 and the agency shall forward the fingerprints to the Department
1736 of Law Enforcement for state processing, and the Department of
1737 Law Enforcement shall forward the fingerprints to the Federal
1738 Bureau of Investigation for a national criminal history record
1739 check. The fingerprints may be retained by the Department of Law
1740 Enforcement under s. 943.05(2)(g). The cost of the state and
1741 national criminal history records checks required by level 2
1742 screening may be borne by the licensee or the person
1743 fingerprinted. Proof of compliance with level 2 screening
1744 standards submitted within the previous 5 years to meet any
1745 provider or professional licensure requirements of the Agency,
1746 the Department of Health, the Agency for Persons with
1747 Disabilities, the Department of Children and Family Services,
1748 the Department of Elderly Affairs, or the Department of
1749 Financial Services for an applicant for a certificate of
1750 authority or provisional certificate of authority to operate a
1751 continuing care retirement community under chapter 651 satisfies
1752 the requirements of this section if the screening standards and
1753 disqualifying offenses are equivalent to those specified in s.
1754 453.04 and this section, and the person subject to screening has
1755 not been unemployed for more than 90 days and such proof is
1756 accompanied, under penalty of perjury, by an affidavit of
1757 compliance with the provisions of chapter 435 and this section
1758 using forms provided by the agency.
1759 (3) All fingerprints must be provided in electronic format.
1760 Screening results shall be reviewed by the agency with respect
1761 to the offenses specified in s. 435.04 and this section, and the
1762 qualifying or disqualifying status of the person named in the
1763 request shall be maintained in a database. The qualifying or
1764 disqualifying status of the person named in the request shall be
1765 posted on a secure website for retrieval by the licensee or
1766 designated agent on the licensee’s behalf.
1767 (4) In addition to the offenses listed in s. 435.04, all
1768 persons required to undergo background screening pursuant to
1769 this part or authorizing statutes must not have an arrest
1770 awaiting final disposition for, must not have been found guilty
1771 of, regardless of adjudication, or entered a plea of nolo
1772 contendere or guilty to, and must not have been adjudicated
1773 delinquent and the record not have been sealed or expunged for
1774 any of the following offenses or any similar offense of another
1775 jurisdiction:
1776 (a) Any authorizing statutes, if the offense was a felony.
1777 (b) This chapter, if the offense was a felony.
1778 (c) Section 409.920, relating to Medicaid provider fraud.
1779 (d) Section 409.9201, relating to Medicaid fraud.
1780 (e) Section 741.28, relating to domestic violence.
1781 (f) Section 817.034, relating to fraudulent acts through
1782 mail, wire, radio, electromagnetic, photoelectronic, or
1783 photooptical systems.
1784 (g) Section 817.234, relating to false and fraudulent
1785 insurance claims.
1786 (h) Section 817.505, relating to patient brokering.
1787 (i) Section 817.568, relating to criminal use of personal
1788 identification information.
1789 (j) Section 817.60, relating to obtaining a credit card
1790 through fraudulent means.
1791 (k) Section 817.61, relating to fraudulent use of credit
1792 cards, if the offense was a felony.
1793 (l) Section 831.01, relating to forgery.
1794 (m) Section 831.02, relating to uttering forged
1795 instruments.
1796 (n) Section 831.07, relating to forging bank bills, checks,
1797 drafts, or promissory notes.
1798 (o) Section 831.09, relating to uttering forged bank bills,
1799 checks, drafts, or promissory notes.
1800 (p) Section 831.30, relating to fraud in obtaining
1801 medicinal drugs.
1802 (q) Section 831.31, relating to the sale, manufacture,
1803 delivery, or possession with the intent to sell, manufacture, or
1804 deliver any counterfeit controlled substance, if the offense was
1805 a felony.
1806 (5) A person who serves as a controlling interest of, is
1807 employed by, or contracts with a licensee on July 31, 2010, who
1808 has been screened and qualified according to standards specified
1809 in s. 435.03 or s. 435.04 must be rescreened by July 31, 2015,
1810 in accordance with the schedule provided in paragraphs (a)-(c).
1811 The agency may adopt rules to establish a schedule to stagger
1812 the implementation of the required rescreening over the 5-year
1813 period, beginning July 31, 2010, through July 31, 2015. If, upon
1814 rescreening, such person has a disqualifying offense that was
1815 not a disqualifying offense at the time of the last screening,
1816 but is a current disqualifying offense and was committed before
1817 the last screening, he or she may apply for an exemption from
1818 the appropriate licensing agency and, if agreed to by the
1819 employer, may continue to perform his or her duties until the
1820 licensing agency renders a decision on the application for
1821 exemption if the person is eligible to apply for an exemption
1822 and the exemption request is received by the agency within 30
1823 days after receipt of the rescreening results by the person. The
1824 rescreening schedule shall be as follows:
1825 (a) Individuals whose last screening was conducted before
1826 December 31, 2003, must be rescreened by July 31, 2013.
1827 (b) Individuals whose last screening was conducted between
1828 January 1, 2004, through December 31, 2007, must be rescreened
1829 by July 31, 2014.
1830 (c) Individuals whose last screening was conducted between
1831 January 1, 2008, through July 31, 2010, must be rescreened by
1832 July 31, 2015.
1833 (6)(5) The costs associated with obtaining the required
1834 screening must be borne by the licensee or the person subject to
1835 screening. Licensees may reimburse persons for these costs. The
1836 Department of Law Enforcement shall charge the agency for
1837 screening pursuant to s. 943.053(3). The agency shall establish
1838 a schedule of fees to cover the costs of screening.
1839 (7)(6)(a) As provided in chapter 435, the agency may grant
1840 an exemption from disqualification to a person who is subject to
1841 this section and who:
1842 1. Does not have an active professional license or
1843 certification from the Department of Health; or
1844 2. Has an active professional license or certification from
1845 the Department of Health but is not providing a service within
1846 the scope of that license or certification.
1847 (b) As provided in chapter 435, the appropriate regulatory
1848 board within the Department of Health, or the department itself
1849 if there is no board, may grant an exemption from
1850 disqualification to a person who is subject to this section and
1851 who has received a professional license or certification from
1852 the Department of Health or a regulatory board within that
1853 department and that person is providing a service within the
1854 scope of his or her licensed or certified practice.
1855 (8)(7) The agency and the Department of Health may adopt
1856 rules pursuant to ss. 120.536(1) and 120.54 to implement this
1857 section, chapter 435, and authorizing statutes requiring
1858 background screening and to implement and adopt criteria
1859 relating to retaining fingerprints pursuant to s. 943.05(2).
1860 (9)(8) There is no unemployment compensation or other
1861 monetary liability on the part of, and no cause of action for
1862 damages arising against, an employer that, upon notice of a
1863 disqualifying offense listed under chapter 435 or this section,
1864 terminates the person against whom the report was issued,
1865 whether or not that person has filed for an exemption with the
1866 Department of Health or the agency.
1867 Section 45. Subsection (9) of section 408.810, Florida
1868 Statutes, is amended to read:
1869 408.810 Minimum licensure requirements.—In addition to the
1870 licensure requirements specified in this part, authorizing
1871 statutes, and applicable rules, each applicant and licensee must
1872 comply with the requirements of this section in order to obtain
1873 and maintain a license.
1874 (9) A controlling interest may not withhold from the agency
1875 any evidence of financial instability, including, but not
1876 limited to, checks returned due to insufficient funds,
1877 delinquent accounts, nonpayment of withholding taxes, unpaid
1878 utility expenses, nonpayment for essential services, or adverse
1879 court action concerning the financial viability of the provider
1880 or any other provider licensed under this part that is under the
1881 control of the controlling interest. A controlling interest
1882 shall notify the agency within 10 days after a court action to
1883 initiate bankruptcy, foreclosure, or eviction proceedings
1884 concerning the provider in which the controlling interest is a
1885 petitioner or defendant. Any person who violates this subsection
1886 commits a misdemeanor of the second degree, punishable as
1887 provided in s. 775.082 or s. 775.083. Each day of continuing
1888 violation is a separate offense.
1889 Section 46. Subsection (3) is added to section 408.813,
1890 Florida Statutes, to read:
1891 408.813 Administrative fines; violations.—As a penalty for
1892 any violation of this part, authorizing statutes, or applicable
1893 rules, the agency may impose an administrative fine.
1894 (3) The agency may impose an administrative fine for a
1895 violation that is not designated as a class I, class II, class
1896 III, or class IV violation. Unless otherwise specified by law,
1897 the amount of the fine may not exceed $500 for each violation.
1898 Unclassified violations include:
1899 (a) Violating any term or condition of a license.
1900 (b) Violating any provision of this part, authorizing
1901 statutes, or applicable rules.
1902 (c) Exceeding licensed capacity.
1903 (d) Providing services beyond the scope of the license.
1904 (e) Violating a moratorium imposed pursuant to s. 408.814.
1905 Section 47. Paragraph (a) of subsection (37) of section
1906 409.912, Florida Statutes, is amended to read:
1907 409.912 Cost-effective purchasing of health care.—The
1908 agency shall purchase goods and services for Medicaid recipients
1909 in the most cost-effective manner consistent with the delivery
1910 of quality medical care. To ensure that medical services are
1911 effectively utilized, the agency may, in any case, require a
1912 confirmation or second physician’s opinion of the correct
1913 diagnosis for purposes of authorizing future services under the
1914 Medicaid program. This section does not restrict access to
1915 emergency services or poststabilization care services as defined
1916 in 42 C.F.R. part 438.114. Such confirmation or second opinion
1917 shall be rendered in a manner approved by the agency. The agency
1918 shall maximize the use of prepaid per capita and prepaid
1919 aggregate fixed-sum basis services when appropriate and other
1920 alternative service delivery and reimbursement methodologies,
1921 including competitive bidding pursuant to s. 287.057, designed
1922 to facilitate the cost-effective purchase of a case-managed
1923 continuum of care. The agency shall also require providers to
1924 minimize the exposure of recipients to the need for acute
1925 inpatient, custodial, and other institutional care and the
1926 inappropriate or unnecessary use of high-cost services. The
1927 agency shall contract with a vendor to monitor and evaluate the
1928 clinical practice patterns of providers in order to identify
1929 trends that are outside the normal practice patterns of a
1930 provider’s professional peers or the national guidelines of a
1931 provider’s professional association. The vendor must be able to
1932 provide information and counseling to a provider whose practice
1933 patterns are outside the norms, in consultation with the agency,
1934 to improve patient care and reduce inappropriate utilization.
1935 The agency may mandate prior authorization, drug therapy
1936 management, or disease management participation for certain
1937 populations of Medicaid beneficiaries, certain drug classes, or
1938 particular drugs to prevent fraud, abuse, overuse, and possible
1939 dangerous drug interactions. The Pharmaceutical and Therapeutics
1940 Committee shall make recommendations to the agency on drugs for
1941 which prior authorization is required. The agency shall inform
1942 the Pharmaceutical and Therapeutics Committee of its decisions
1943 regarding drugs subject to prior authorization. The agency is
1944 authorized to limit the entities it contracts with or enrolls as
1945 Medicaid providers by developing a provider network through
1946 provider credentialing. The agency may competitively bid single
1947 source-provider contracts if procurement of goods or services
1948 results in demonstrated cost savings to the state without
1949 limiting access to care. The agency may limit its network based
1950 on the assessment of beneficiary access to care, provider
1951 availability, provider quality standards, time and distance
1952 standards for access to care, the cultural competence of the
1953 provider network, demographic characteristics of Medicaid
1954 beneficiaries, practice and provider-to-beneficiary standards,
1955 appointment wait times, beneficiary use of services, provider
1956 turnover, provider profiling, provider licensure history,
1957 previous program integrity investigations and findings, peer
1958 review, provider Medicaid policy and billing compliance records,
1959 clinical and medical record audits, and other factors. Providers
1960 are not entitled to enrollment in the Medicaid provider network.
1961 The agency shall determine instances in which allowing Medicaid
1962 beneficiaries to purchase durable medical equipment and other
1963 goods is less expensive to the Medicaid program than long-term
1964 rental of the equipment or goods. The agency may establish rules
1965 to facilitate purchases in lieu of long-term rentals in order to
1966 protect against fraud and abuse in the Medicaid program as
1967 defined in s. 409.913. The agency may seek federal waivers
1968 necessary to administer these policies.
1969 (37)(a) The agency shall implement a Medicaid prescribed
1970 drug spending-control program that includes the following
1971 components:
1972 1. A Medicaid preferred drug list, which shall be a listing
1973 of cost-effective therapeutic options recommended by the
1974 Medicaid Pharmacy and Therapeutics Committee established
1975 pursuant to s. 409.91195 and adopted by the agency for each
1976 therapeutic class on the preferred drug list. At the discretion
1977 of the committee, and when feasible, the preferred drug list
1978 should include at least two products in a therapeutic class. The
1979 agency may post the preferred drug list and updates to the list
1980 on an Internet website without following the rulemaking
1981 procedures of chapter 120. Antiretroviral agents are excluded
1982 from the preferred drug list. The agency shall also limit the
1983 amount of a prescribed drug dispensed to no more than a 34-day
1984 supply unless the drug products’ smallest marketed package is
1985 greater than a 34-day supply, or the drug is determined by the
1986 agency to be a maintenance drug in which case a 100-day maximum
1987 supply may be authorized. The agency may seek any federal
1988 waivers necessary to implement these cost-control programs and
1989 to continue participation in the federal Medicaid rebate
1990 program, or alternatively to negotiate state-only manufacturer
1991 rebates. The agency may adopt rules to administer this
1992 subparagraph. The agency shall continue to provide unlimited
1993 contraceptive drugs and items. The agency must establish
1994 procedures to ensure that:
1995 a. There is a response to a request for prior consultation
1996 by telephone or other telecommunication device within 24 hours
1997 after receipt of a request for prior consultation; and
1998 b. A 72-hour supply of the drug prescribed is provided in
1999 an emergency or when the agency does not provide a response
2000 within 24 hours as required by sub-subparagraph a.
2001 2. Reimbursement to pharmacies for Medicaid prescribed
2002 drugs shall be set at the lowest of: the average wholesale price
2003 (AWP) minus 16.4 percent, the wholesaler acquisition cost (WAC)
2004 plus 1.5 percent, the federal upper limit (FUL), the state
2005 maximum allowable cost (SMAC), or the usual and customary (UAC)
2006 charge billed by the provider.
2007 3. The agency shall develop and implement a process for
2008 managing the drug therapies of Medicaid recipients who are using
2009 significant numbers of prescribed drugs each month. The
2010 management process may include, but is not limited to,
2011 comprehensive, physician-directed medical-record reviews, claims
2012 analyses, and case evaluations to determine the medical
2013 necessity and appropriateness of a patient’s treatment plan and
2014 drug therapies. The agency may contract with a private
2015 organization to provide drug-program-management services. The
2016 Medicaid drug benefit management program shall include
2017 initiatives to manage drug therapies for HIV/AIDS patients,
2018 patients using 20 or more unique prescriptions in a 180-day
2019 period, and the top 1,000 patients in annual spending. The
2020 agency shall enroll any Medicaid recipient in the drug benefit
2021 management program if he or she meets the specifications of this
2022 provision and is not enrolled in a Medicaid health maintenance
2023 organization.
2024 4. The agency may limit the size of its pharmacy network
2025 based on need, competitive bidding, price negotiations,
2026 credentialing, or similar criteria. The agency shall give
2027 special consideration to rural areas in determining the size and
2028 location of pharmacies included in the Medicaid pharmacy
2029 network. A pharmacy credentialing process may include criteria
2030 such as a pharmacy’s full-service status, location, size,
2031 patient educational programs, patient consultation, disease
2032 management services, and other characteristics. The agency may
2033 impose a moratorium on Medicaid pharmacy enrollment if it is
2034 determined that it has a sufficient number of Medicaid
2035 participating providers. The agency must allow dispensing
2036 practitioners to participate as a part of the Medicaid pharmacy
2037 network regardless of the practitioner’s proximity to any other
2038 entity that is dispensing prescription drugs under the Medicaid
2039 program. A dispensing practitioner must meet all credentialing
2040 requirements applicable to his or her practice, as determined by
2041 the agency.
2042 5. The agency shall develop and implement a program that
2043 requires Medicaid practitioners who prescribe drugs to use a
2044 counterfeit-proof prescription pad for Medicaid prescriptions.
2045 The agency shall require the use of standardized counterfeit
2046 proof prescription pads by Medicaid-participating prescribers or
2047 prescribers who write prescriptions for Medicaid recipients. The
2048 agency may implement the program in targeted geographic areas or
2049 statewide.
2050 6. The agency may enter into arrangements that require
2051 manufacturers of generic drugs prescribed to Medicaid recipients
2052 to provide rebates of at least 15.1 percent of the average
2053 manufacturer price for the manufacturer’s generic products.
2054 These arrangements shall require that if a generic-drug
2055 manufacturer pays federal rebates for Medicaid-reimbursed drugs
2056 at a level below 15.1 percent, the manufacturer must provide a
2057 supplemental rebate to the state in an amount necessary to
2058 achieve a 15.1-percent rebate level.
2059 7. The agency may establish a preferred drug list as
2060 described in this subsection, and, pursuant to the establishment
2061 of such preferred drug list, negotiate supplemental rebates from
2062 manufacturers that are in addition to those required by Title
2063 XIX of the Social Security Act and at no less than 14 percent of
2064 the average manufacturer price as defined in 42 U.S.C. s. 1936
2065 on the last day of a quarter unless the federal or supplemental
2066 rebate, or both, equals or exceeds 29 percent. There is no upper
2067 limit on the supplemental rebates the agency may negotiate. The
2068 agency may determine that specific products, brand-name or
2069 generic, are competitive at lower rebate percentages. Agreement
2070 to pay the minimum supplemental rebate percentage guarantees a
2071 manufacturer that the Medicaid Pharmaceutical and Therapeutics
2072 Committee will consider a product for inclusion on the preferred
2073 drug list. However, a pharmaceutical manufacturer is not
2074 guaranteed placement on the preferred drug list by simply paying
2075 the minimum supplemental rebate. Agency decisions will be made
2076 on the clinical efficacy of a drug and recommendations of the
2077 Medicaid Pharmaceutical and Therapeutics Committee, as well as
2078 the price of competing products minus federal and state rebates.
2079 The agency may contract with an outside agency or contractor to
2080 conduct negotiations for supplemental rebates. For the purposes
2081 of this section, the term “supplemental rebates” means cash
2082 rebates. Value-added programs as a substitution for supplemental
2083 rebates are prohibited. The agency may seek any federal waivers
2084 to implement this initiative.
2085 8. The agency shall expand home delivery of pharmacy
2086 products. The agency may amend the state plan and issue a
2087 procurement, as necessary, in order to implement this program.
2088 The procurements must include agreements with a pharmacy or
2089 pharmacies located in the state to provide mail order delivery
2090 services at no cost to the recipients who elect to receive home
2091 delivery of pharmacy products. The procurement must focus on
2092 serving recipients with chronic diseases for which pharmacy
2093 expenditures represent a significant portion of Medicaid
2094 pharmacy expenditures or which impact a significant portion of
2095 the Medicaid population. The agency may seek and implement any
2096 federal waivers necessary to implement this subparagraph.
2097 9. The agency shall limit to one dose per month any drug
2098 prescribed to treat erectile dysfunction.
2099 10.a. The agency may implement a Medicaid behavioral drug
2100 management system. The agency may contract with a vendor that
2101 has experience in operating behavioral drug management systems
2102 to implement this program. The agency may seek federal waivers
2103 to implement this program.
2104 b. The agency, in conjunction with the Department of
2105 Children and Family Services, may implement the Medicaid
2106 behavioral drug management system that is designed to improve
2107 the quality of care and behavioral health prescribing practices
2108 based on best practice guidelines, improve patient adherence to
2109 medication plans, reduce clinical risk, and lower prescribed
2110 drug costs and the rate of inappropriate spending on Medicaid
2111 behavioral drugs. The program may include the following
2112 elements:
2113 (I) Provide for the development and adoption of best
2114 practice guidelines for behavioral health-related drugs such as
2115 antipsychotics, antidepressants, and medications for treating
2116 bipolar disorders and other behavioral conditions; translate
2117 them into practice; review behavioral health prescribers and
2118 compare their prescribing patterns to a number of indicators
2119 that are based on national standards; and determine deviations
2120 from best practice guidelines.
2121 (II) Implement processes for providing feedback to and
2122 educating prescribers using best practice educational materials
2123 and peer-to-peer consultation.
2124 (III) Assess Medicaid beneficiaries who are outliers in
2125 their use of behavioral health drugs with regard to the numbers
2126 and types of drugs taken, drug dosages, combination drug
2127 therapies, and other indicators of improper use of behavioral
2128 health drugs.
2129 (IV) Alert prescribers to patients who fail to refill
2130 prescriptions in a timely fashion, are prescribed multiple same
2131 class behavioral health drugs, and may have other potential
2132 medication problems.
2133 (V) Track spending trends for behavioral health drugs and
2134 deviation from best practice guidelines.
2135 (VI) Use educational and technological approaches to
2136 promote best practices, educate consumers, and train prescribers
2137 in the use of practice guidelines.
2138 (VII) Disseminate electronic and published materials.
2139 (VIII) Hold statewide and regional conferences.
2140 (IX) Implement a disease management program with a model
2141 quality-based medication component for severely mentally ill
2142 individuals and emotionally disturbed children who are high
2143 users of care.
2144 11. The agency shall implement a Medicaid prescription drug
2145 management system.
2146 a. The agency may contract with a vendor that has
2147 experience in operating prescription drug management systems in
2148 order to implement this system. Any management system that is
2149 implemented in accordance with this subparagraph must rely on
2150 cooperation between physicians and pharmacists to determine
2151 appropriate practice patterns and clinical guidelines to improve
2152 the prescribing, dispensing, and use of drugs in the Medicaid
2153 program. The agency may seek federal waivers to implement this
2154 program.
2155 b. The drug management system must be designed to improve
2156 the quality of care and prescribing practices based on best
2157 practice guidelines, improve patient adherence to medication
2158 plans, reduce clinical risk, and lower prescribed drug costs and
2159 the rate of inappropriate spending on Medicaid prescription
2160 drugs. The program must:
2161 (I) Provide for the adoption of best practice guidelines
2162 for the prescribing and use of drugs in the Medicaid program,
2163 including translating best practice guidelines into practice;
2164 reviewing prescriber patterns and comparing them to indicators
2165 that are based on national standards and practice patterns of
2166 clinical peers in their community, statewide, and nationally;
2167 and determine deviations from best practice guidelines.
2168 (II) Implement processes for providing feedback to and
2169 educating prescribers using best practice educational materials
2170 and peer-to-peer consultation.
2171 (III) Assess Medicaid recipients who are outliers in their
2172 use of a single or multiple prescription drugs with regard to
2173 the numbers and types of drugs taken, drug dosages, combination
2174 drug therapies, and other indicators of improper use of
2175 prescription drugs.
2176 (IV) Alert prescribers to recipients who fail to refill
2177 prescriptions in a timely fashion, are prescribed multiple drugs
2178 that may be redundant or contraindicated, or may have other
2179 potential medication problems.
2180 12. The agency may contract for drug rebate administration,
2181 including, but not limited to, calculating rebate amounts,
2182 invoicing manufacturers, negotiating disputes with
2183 manufacturers, and maintaining a database of rebate collections.
2184 13. The agency may specify the preferred daily dosing form
2185 or strength for the purpose of promoting best practices with
2186 regard to the prescribing of certain drugs as specified in the
2187 General Appropriations Act and ensuring cost-effective
2188 prescribing practices.
2189 14. The agency may require prior authorization for
2190 Medicaid-covered prescribed drugs. The agency may prior
2191 authorize the use of a product:
2192 a. For an indication not approved in labeling;
2193 b. To comply with certain clinical guidelines; or
2194 c. If the product has the potential for overuse, misuse, or
2195 abuse.
2196
2197 The agency may require the prescribing professional to provide
2198 information about the rationale and supporting medical evidence
2199 for the use of a drug. The agency may post prior authorization
2200 and step-edit criteria, and protocol, and updates to the list of
2201 drugs that are subject to prior authorization on the agency’s an
2202 Internet website within 21 days after the prior authorization
2203 criteria, protocol, or updates are approved by the agency
2204 without amending its rule or engaging in additional rulemaking.
2205 15. The agency, in conjunction with the Pharmaceutical and
2206 Therapeutics Committee, may require age-related prior
2207 authorizations for certain prescribed drugs. The agency may
2208 preauthorize the use of a drug for a recipient who may not meet
2209 the age requirement or may exceed the length of therapy for use
2210 of this product as recommended by the manufacturer and approved
2211 by the Food and Drug Administration. Prior authorization may
2212 require the prescribing professional to provide information
2213 about the rationale and supporting medical evidence for the use
2214 of a drug.
2215 16. The agency shall implement a step-therapy prior
2216 authorization approval process for medications excluded from the
2217 preferred drug list. Medications listed on the preferred drug
2218 list must be used within the previous 12 months before the
2219 alternative medications that are not listed. The step-therapy
2220 prior authorization may require the prescriber to use the
2221 medications of a similar drug class or for a similar medical
2222 indication unless contraindicated in the Food and Drug
2223 Administration labeling. The trial period between the specified
2224 steps may vary according to the medical indication. The step
2225 therapy approval process shall be developed in accordance with
2226 the committee as stated in s. 409.91195(7) and (8). A drug
2227 product may be approved without meeting the step-therapy prior
2228 authorization criteria if the prescribing physician provides the
2229 agency with additional written medical or clinical documentation
2230 that the product is medically necessary because:
2231 a. There is not a drug on the preferred drug list to treat
2232 the disease or medical condition which is an acceptable clinical
2233 alternative;
2234 b. The alternatives have been ineffective in the treatment
2235 of the beneficiary’s disease; or
2236 c. Based on historic evidence and known characteristics of
2237 the patient and the drug, the drug is likely to be ineffective,
2238 or the number of doses have been ineffective.
2239
2240 The agency shall work with the physician to determine the best
2241 alternative for the patient. The agency may adopt rules waiving
2242 the requirements for written clinical documentation for specific
2243 drugs in limited clinical situations.
2244 17. The agency shall implement a return and reuse program
2245 for drugs dispensed by pharmacies to institutional recipients,
2246 which includes payment of a $5 restocking fee for the
2247 implementation and operation of the program. The return and
2248 reuse program shall be implemented electronically and in a
2249 manner that promotes efficiency. The program must permit a
2250 pharmacy to exclude drugs from the program if it is not
2251 practical or cost-effective for the drug to be included and must
2252 provide for the return to inventory of drugs that cannot be
2253 credited or returned in a cost-effective manner. The agency
2254 shall determine if the program has reduced the amount of
2255 Medicaid prescription drugs which are destroyed on an annual
2256 basis and if there are additional ways to ensure more
2257 prescription drugs are not destroyed which could safely be
2258 reused.
2259 Section 48. Subsections (1), (7), and (8) of section
2260 409.91195, Florida Statutes, are amended to read:
2261 409.91195 Medicaid Pharmaceutical and Therapeutics
2262 Committee.—There is created a Medicaid Pharmaceutical and
2263 Therapeutics Committee within the agency for the purpose of
2264 developing a Medicaid preferred drug list.
2265 (1)(a) The committee shall be composed of 11 members
2266 appointed by the Governor as follows: one member licensed under
2267 chapter 458 or chapter 459 who is nominated by the Florida
2268 Medical Association; one member licensed under chapter 459 who
2269 is nominated by the Florida Osteopathic Medical Association; one
2270 member licensed under chapter 458 or chapter 459 who is
2271 nominated by the American Academy of Family Physicians, Florida
2272 Chapter; one member licensed under chapter 458 or chapter 459
2273 who is nominated by the American Academy of Pediatrics, Florida
2274 Chapter; one member licensed under chapter 458 or chapter 459
2275 nominated by the Florida Psychiatric Society; one member
2276 licensed under chapter 465 who is nominated by the Florida
2277 Pharmacy Association; one member licensed under chapter 465 who
2278 is nominated by the Florida Society of Health System
2279 Pharmacists, Inc.; one member licensed under chapter 465 who is
2280 nominated by the Florida Retail Federation; one member licensed
2281 under chapter 465 who works in a retail setting for an
2282 independent, nonchain pharmacy; one member licensed under
2283 chapter 458 or chapter 459 who is nominated by the Florida
2284 Academy of Physician Assistants; and one consumer representative
2285 who represents a patient advocacy group.
2286 (b) Each member of the committee, except the consumer
2287 representative, must practice in this state and participate in
2288 the Florida Medicaid Fee for Service Pharmacy Program.
2289 (c) The Governor shall appoint the members for 2-year
2290 terms. Members may be appointed to more than one term. The
2291 agency shall serve as staff for the committee and assist the
2292 members with administrative duties. Four members shall be
2293 physicians, licensed under chapter 458; one member licensed
2294 under chapter 459; five members shall be pharmacists licensed
2295 under chapter 465; and one member shall be a consumer
2296 representative. The members shall be appointed to serve for
2297 terms of 2 years from the date of their appointment. Members may
2298 be appointed to more than one term. The agency shall serve as
2299 staff for the committee and assist them with all ministerial
2300 duties. The Governor shall ensure that at least some of the
2301 members of the committee represent Medicaid participating
2302 physicians and pharmacies serving all segments and diversity of
2303 the Medicaid population, and have experience in either
2304 developing or practicing under a preferred drug list. At least
2305 one of the members shall represent the interests of
2306 pharmaceutical manufacturers.
2307 (7) The committee shall ensure that interested parties,
2308 including pharmaceutical manufacturers agreeing to provide a
2309 supplemental rebate as outlined in this chapter, have an
2310 opportunity to present public testimony to the committee with
2311 information or evidence supporting inclusion of a product on the
2312 preferred drug list. Such public testimony shall occur prior to
2313 any recommendations made by the committee for inclusion or
2314 exclusion from the preferred drug list, allow for members of the
2315 committee to ask questions of the presenters of the public
2316 testimony, and allow for 3 minutes of testimony for each drug
2317 reviewed. The agency may not limit the number of interested
2318 parties that provide public testimony. Upon timely notice, the
2319 agency shall ensure that any drug that has been approved or had
2320 any of its particular uses approved by the United States Food
2321 and Drug Administration under a priority review classification
2322 will be reviewed by the committee at the next regularly
2323 scheduled meeting following 3 months of distribution of the drug
2324 to the general public.
2325 (8) The committee shall develop its preferred drug list
2326 recommendations by considering the clinical efficacy, safety,
2327 and cost-effectiveness of a product. If the agency does not
2328 follow a recommendation of the committee, the committee members
2329 must be informed in writing of the agency’s action at the next
2330 meeting of the committee following the reversal of its
2331 recommendation.
2332 Section 49. Effective upon this act becoming a law,
2333 paragraph (e) is added to subsection (1) of section 409.975,
2334 Florida Statutes, to read:
2335 409.975 Managed care plan accountability.—In addition to
2336 the requirements of s. 409.967, plans and providers
2337 participating in the managed medical assistance program shall
2338 comply with the requirements of this section.
2339 (1) PROVIDER NETWORKS.—Managed care plans must develop and
2340 maintain provider networks that meet the medical needs of their
2341 enrollees in accordance with standards established pursuant to
2342 s. 409.967(2)(b). Except as provided in this section, managed
2343 care plans may limit the providers in their networks based on
2344 credentials, quality indicators, and price.
2345 (e) Before the selection of managed care plans as specified
2346 in s. 409.966, each essential provider and each hospital that
2347 are necessary in order for a managed care plan to demonstrate an
2348 adequate network, as determined by the agency, are a part of
2349 that managed care plan’s network for purposes of the provider’s
2350 or hospital’s application for enrollment or expansion in the
2351 Medicaid program. A managed care plan’s payment under this
2352 section to an essential provider must be made in accordance with
2353 this section.
2354 Section 50. Subsection (6) of section 429.11, Florida
2355 Statutes, is repealed.
2356 Section 51. Subsection (1) of section 429.294, Florida
2357 Statutes is amended to read:
2358 429.294 Availability of facility records for investigation
2359 of resident’s rights violations and defenses; penalty.—
2360 (1) Failure to provide complete copies of a resident’s
2361 records, including, but not limited to, all medical records and
2362 the resident’s chart, within the control or possession of the
2363 facility within 10 days, in accordance with the provisions of s.
2364 400.141(3)400.145, shall constitute evidence of failure of that
2365 party to comply with good faith discovery requirements and shall
2366 waive the good faith certificate and presuit notice requirements
2367 under this part by the requesting party.
2368 Section 52. Subsections (1) and (5) of section 429.71,
2369 Florida Statutes, are amended to read:
2370 429.71 Classification of violations deficiencies;
2371 administrative fines.—
2372 (1) In addition to the requirements of part II of chapter
2373 408 and in addition to any other liability or penalty provided
2374 by law, the agency may impose an administrative fine on a
2375 provider according to the following classification:
2376 (a) Class I violations are defined in s. 408.813 those
2377 conditions or practices related to the operation and maintenance
2378 of an adult family-care home or to the care of residents which
2379 the agency determines present an imminent danger to the
2380 residents or guests of the facility or a substantial probability
2381 that death or serious physical or emotional harm would result
2382 therefrom. The condition or practice that constitutes a class I
2383 violation must be abated or eliminated within 24 hours, unless a
2384 fixed period, as determined by the agency, is required for
2385 correction. A class I violation deficiency is subject to an
2386 administrative fine in an amount not less than $500 and not
2387 exceeding $1,000 for each violation. A fine may be levied
2388 notwithstanding the correction of the deficiency.
2389 (b) Class II violations are defined in s. 408.813 those
2390 conditions or practices related to the operation and maintenance
2391 of an adult family-care home or to the care of residents which
2392 the agency determines directly threaten the physical or
2393 emotional health, safety, or security of the residents, other
2394 than class I violations. A class II violation is subject to an
2395 administrative fine in an amount not less than $250 and not
2396 exceeding $500 for each violation. A citation for a class II
2397 violation must specify the time within which the violation is
2398 required to be corrected. If a class II violation is corrected
2399 within the time specified, no civil penalty shall be imposed,
2400 unless it is a repeated offense.
2401 (c) Class III violations are defined in s. 408.813 those
2402 conditions or practices related to the operation and maintenance
2403 of an adult family-care home or to the care of residents which
2404 the agency determines indirectly or potentially threaten the
2405 physical or emotional health, safety, or security of residents,
2406 other than class I or class II violations. A class III violation
2407 is subject to an administrative fine in an amount not less than
2408 $100 and not exceeding $250 for each violation. A citation for a
2409 class III violation shall specify the time within which the
2410 violation is required to be corrected. If a class III violation
2411 is corrected within the time specified, no civil penalty shall
2412 be imposed, unless it is a repeated violation offense.
2413 (d) Class IV violations are defined in s. 408.813 those
2414 conditions or occurrences related to the operation and
2415 maintenance of an adult family-care home, or related to the
2416 required reports, forms, or documents, which do not have the
2417 potential of negatively affecting the residents. A provider that
2418 does not correct A class IV violation within the time limit
2419 specified by the agency is subject to an administrative fine in
2420 an amount not less than $50 and not exceeding $100 for each
2421 violation. Any class IV violation that is corrected during the
2422 time the agency survey is conducted will be identified as an
2423 agency finding and not as a violation, unless it is a repeat
2424 violation.
2425 (5) As an alternative to or in conjunction with an
2426 administrative action against a provider, the agency may request
2427 a plan of corrective action that demonstrates a good faith
2428 effort to remedy each violation by a specific date, subject to
2429 the approval of the agency.
2430 Section 53. Section 429.915, Florida Statutes, is amended
2431 to read:
2432 429.915 Conditional license.—In addition to the license
2433 categories available in part II of chapter 408, the agency may
2434 issue a conditional license to an applicant for license renewal
2435 or change of ownership if the applicant fails to meet all
2436 standards and requirements for licensure. A conditional license
2437 issued under this subsection must be limited to a specific
2438 period not exceeding 6 months, as determined by the agency, and
2439 must be accompanied by an approved plan of correction.
2440 Section 54. Subsection (3) of section 430.80, Florida
2441 Statutes, is amended to read:
2442 430.80 Implementation of a teaching nursing home pilot
2443 project.—
2444 (3) To be designated as a teaching nursing home, a nursing
2445 home licensee must, at a minimum:
2446 (a) Provide a comprehensive program of integrated senior
2447 services that include institutional services and community-based
2448 services;
2449 (b) Participate in a nationally recognized accreditation
2450 program and hold a valid accreditation, such as the
2451 accreditation awarded by the Joint Commission on Accreditation
2452 of Healthcare Organizations, or, at the time of initial
2453 designation, possess a Gold Seal Award as conferred by the state
2454 on its licensed nursing home;
2455 (c) Have been in business in this state for a minimum of 10
2456 consecutive years;
2457 (d) Demonstrate an active program in multidisciplinary
2458 education and research that relates to gerontology;
2459 (e) Have a formalized contractual relationship with at
2460 least one accredited health profession education program located
2461 in this state;
2462 (f) Have senior staff members who hold formal faculty
2463 appointments at universities, which must include at least one
2464 accredited health profession education program; and
2465 (g) Maintain insurance coverage pursuant to s.
2466 400.141(1)(q) s. 400.141(1)(s) or proof of financial
2467 responsibility in a minimum amount of $750,000. Such proof of
2468 financial responsibility may include:
2469 1. Maintaining an escrow account consisting of cash or
2470 assets eligible for deposit in accordance with s. 625.52; or
2471 2. Obtaining and maintaining pursuant to chapter 675 an
2472 unexpired, irrevocable, nontransferable and nonassignable letter
2473 of credit issued by any bank or savings association organized
2474 and existing under the laws of this state or any bank or savings
2475 association organized under the laws of the United States that
2476 has its principal place of business in this state or has a
2477 branch office which is authorized to receive deposits in this
2478 state. The letter of credit shall be used to satisfy the
2479 obligation of the facility to the claimant upon presentment of a
2480 final judgment indicating liability and awarding damages to be
2481 paid by the facility or upon presentment of a settlement
2482 agreement signed by all parties to the agreement when such final
2483 judgment or settlement is a result of a liability claim against
2484 the facility.
2485 Section 55. Paragraph (h) of subsection (2) of section
2486 430.81, Florida Statutes, is amended to read:
2487 430.81 Implementation of a teaching agency for home and
2488 community-based care.—
2489 (2) The Department of Elderly Affairs may designate a home
2490 health agency as a teaching agency for home and community-based
2491 care if the home health agency:
2492 (h) Maintains insurance coverage pursuant to s.
2493 400.141(1)(q) s. 400.141(1)(s) or proof of financial
2494 responsibility in a minimum amount of $750,000. Such proof of
2495 financial responsibility may include:
2496 1. Maintaining an escrow account consisting of cash or
2497 assets eligible for deposit in accordance with s. 625.52; or
2498 2. Obtaining and maintaining, pursuant to chapter 675, an
2499 unexpired, irrevocable, nontransferable, and nonassignable
2500 letter of credit issued by any bank or savings association
2501 authorized to do business in this state. This letter of credit
2502 shall be used to satisfy the obligation of the agency to the
2503 claimant upon presentation of a final judgment indicating
2504 liability and awarding damages to be paid by the facility or
2505 upon presentment of a settlement agreement signed by all parties
2506 to the agreement when such final judgment or settlement is a
2507 result of a liability claim against the agency.
2508 Section 56. Paragraph (d) of subsection (9) of section
2509 440.102, Florida Statutes, is repealed.
2510 Section 57. Subsection (1) of section 483.035, Florida
2511 Statutes, is amended to read:
2512 483.035 Clinical laboratories operated by practitioners for
2513 exclusive use; licensure and regulation.—
2514 (1) A clinical laboratory operated by one or more
2515 practitioners licensed under chapter 458, chapter 459, chapter
2516 460, chapter 461, chapter 462, or chapter 466, or as an advanced
2517 registered nurse practitioner licensed under part I in chapter
2518 464, exclusively in connection with the diagnosis and treatment
2519 of their own patients, must be licensed under this part and must
2520 comply with the provisions of this part, except that the agency
2521 shall adopt rules for staffing, for personnel, including
2522 education and training of personnel, for proficiency testing,
2523 and for construction standards relating to the licensure and
2524 operation of the laboratory based upon and not exceeding the
2525 same standards contained in the federal Clinical Laboratory
2526 Improvement Amendments of 1988 and the federal regulations
2527 adopted thereunder.
2528 Section 58. Subsections (1) and (9) of section 483.051,
2529 Florida Statutes, are amended to read:
2530 483.051 Powers and duties of the agency.—The agency shall
2531 adopt rules to implement this part, which rules must include,
2532 but are not limited to, the following:
2533 (1) LICENSING; QUALIFICATIONS.—The agency shall provide for
2534 biennial licensure of all nonwaived clinical laboratories
2535 meeting the requirements of this part and shall prescribe the
2536 qualifications necessary for such licensure, including, but not
2537 limited to, application for or proof of a federal Clinical
2538 Laboratory Improvement Amendment (CLIA) certificate. For
2539 purposes of this section, the term “nonwaived clinical
2540 laboratories” means laboratories that perform any test that the
2541 Centers for Medicare and Medicaid Services has determined does
2542 not qualify for a certificate of waiver under the Clinical
2543 Laboratory Improvement Amendments of 1988 and the federal rules
2544 adopted thereunder.
2545 (9) ALTERNATE-SITE TESTING.—The agency, in consultation
2546 with the Board of Clinical Laboratory Personnel, shall adopt, by
2547 rule, the criteria for alternate-site testing to be performed
2548 under the supervision of a clinical laboratory director. The
2549 elements to be addressed in the rule include, but are not
2550 limited to: a hospital internal needs assessment; a protocol of
2551 implementation including tests to be performed and who will
2552 perform the tests; criteria to be used in selecting the method
2553 of testing to be used for alternate-site testing; minimum
2554 training and education requirements for those who will perform
2555 alternate-site testing, such as documented training, licensure,
2556 certification, or other medical professional background not
2557 limited to laboratory professionals; documented inservice
2558 training as well as initial and ongoing competency validation;
2559 an appropriate internal and external quality control protocol;
2560 an internal mechanism for identifying and tracking alternate
2561 site testing by the central laboratory; and recordkeeping
2562 requirements. Alternate-site testing locations must register
2563 when the clinical laboratory applies to renew its license. For
2564 purposes of this subsection, the term “alternate-site testing”
2565 means any laboratory testing done under the administrative
2566 control of a hospital, but performed out of the physical or
2567 administrative confines of the central laboratory.
2568 Section 59. Section 483.245, Florida Statutes, is amended
2569 to read:
2570 483.245 Rebates prohibited; penalties; private action.—
2571 (1) It is unlawful for any person to pay or receive any
2572 commission, bonus, kickback, or rebate or engage in any split
2573 fee arrangement in any form whatsoever with any dialysis
2574 facility, physician, surgeon, organization, agency, or person,
2575 either directly or indirectly, for patients referred to a
2576 clinical laboratory licensed under this part. A clinical
2577 laboratory licensed under this part is prohibited from placing,
2578 directly or indirectly, through an independent staffing company
2579 or lease arrangement, or otherwise, a specimen collector or
2580 other personnel in any physician’s office, unless the clinical
2581 lab and the physician’s office are owned and operated by the
2582 same entity.
2583 (2) The agency shall adopt rules that assess administrative
2584 penalties for acts prohibited by subsection (1). In the case of
2585 an entity licensed by the agency, such penalties may include any
2586 disciplinary action available to the agency under the
2587 appropriate licensing laws. In the case of an entity not
2588 licensed by the agency, such penalties may include:
2589 (a) A fine not to exceed $1,000;
2590 (b) If applicable, a recommendation by the agency to the
2591 appropriate licensing board that disciplinary action be taken.
2592 (3) Any person aggrieved by a violation of this section may
2593 bring a civil action for appropriate relief, including an action
2594 for a declaratory judgment, injunctive relief, and actual
2595 damages.
2596 Section 60. Section 483.294, Florida Statutes, is amended
2597 to read:
2598 483.294 Inspection of centers.—In accordance with s.
2599 408.811, the agency shall biennially, at least once annually,
2600 inspect the premises and operations of all centers subject to
2601 licensure under this part.
2602 Section 61. Paragraph (a) of subsection (54) of section
2603 499.003, Florida Statutes, is amended to read:
2604 499.003 Definitions of terms used in this part.—As used in
2605 this part, the term:
2606 (54) “Wholesale distribution” means distribution of
2607 prescription drugs to persons other than a consumer or patient,
2608 but does not include:
2609 (a) Any of the following activities, which is not a
2610 violation of s. 499.005(21) if such activity is conducted in
2611 accordance with s. 499.01(2)(g):
2612 1. The purchase or other acquisition by a hospital or other
2613 health care entity that is a member of a group purchasing
2614 organization of a prescription drug for its own use from the
2615 group purchasing organization or from other hospitals or health
2616 care entities that are members of that organization.
2617 2. The sale, purchase, or trade of a prescription drug or
2618 an offer to sell, purchase, or trade a prescription drug by a
2619 charitable organization described in s. 501(c)(3) of the
2620 Internal Revenue Code of 1986, as amended and revised, to a
2621 nonprofit affiliate of the organization to the extent otherwise
2622 permitted by law.
2623 3. The sale, purchase, or trade of a prescription drug or
2624 an offer to sell, purchase, or trade a prescription drug among
2625 hospitals or other health care entities that are under common
2626 control. For purposes of this subparagraph, “common control”
2627 means the power to direct or cause the direction of the
2628 management and policies of a person or an organization, whether
2629 by ownership of stock, by voting rights, by contract, or
2630 otherwise.
2631 4. The sale, purchase, trade, or other transfer of a
2632 prescription drug from or for any federal, state, or local
2633 government agency or any entity eligible to purchase
2634 prescription drugs at public health services prices pursuant to
2635 Pub. L. No. 102-585, s. 602 to a contract provider or its
2636 subcontractor for eligible patients of the agency or entity
2637 under the following conditions:
2638 a. The agency or entity must obtain written authorization
2639 for the sale, purchase, trade, or other transfer of a
2640 prescription drug under this subparagraph from the State Surgeon
2641 General or his or her designee.
2642 b. The contract provider or subcontractor must be
2643 authorized by law to administer or dispense prescription drugs.
2644 c. In the case of a subcontractor, the agency or entity
2645 must be a party to and execute the subcontract.
2646 d. A contract provider or subcontractor must maintain
2647 separate and apart from other prescription drug inventory any
2648 prescription drugs of the agency or entity in its possession.
2649 d.e. The contract provider and subcontractor must maintain
2650 and produce immediately for inspection all records of movement
2651 or transfer of all the prescription drugs belonging to the
2652 agency or entity, including, but not limited to, the records of
2653 receipt and disposition of prescription drugs. Each contractor
2654 and subcontractor dispensing or administering these drugs must
2655 maintain and produce records documenting the dispensing or
2656 administration. Records that are required to be maintained
2657 include, but are not limited to, a perpetual inventory itemizing
2658 drugs received and drugs dispensed by prescription number or
2659 administered by patient identifier, which must be submitted to
2660 the agency or entity quarterly.
2661 e.f. The contract provider or subcontractor may administer
2662 or dispense the prescription drugs only to the eligible patients
2663 of the agency or entity or must return the prescription drugs
2664 for or to the agency or entity. The contract provider or
2665 subcontractor must require proof from each person seeking to
2666 fill a prescription or obtain treatment that the person is an
2667 eligible patient of the agency or entity and must, at a minimum,
2668 maintain a copy of this proof as part of the records of the
2669 contractor or subcontractor required under sub-subparagraph e.
2670 f.g. In addition to the departmental inspection authority
2671 set forth in s. 499.051, the establishment of the contract
2672 provider and subcontractor and all records pertaining to
2673 prescription drugs subject to this subparagraph shall be subject
2674 to inspection by the agency or entity. All records relating to
2675 prescription drugs of a manufacturer under this subparagraph
2676 shall be subject to audit by the manufacturer of those drugs,
2677 without identifying individual patient information.
2678 Section 62. Effective May 1, 2012, paragraph (h) is added
2679 to subsection (1) of section 627.602, Florida Statutes, to read:
2680 627.602 Scope, format of policy.—
2681 (1) Each health insurance policy delivered or issued for
2682 delivery to any person in this state must comply with all
2683 applicable provisions of this code and all of the following
2684 requirements:
2685 (h) Section 641.312 and the provisions of the Employee
2686 Retirement Income Security Act of 1974, as implemented by 29
2687 C.F.R. s. 2560.503-1, relating to internal grievances. This
2688 paragraph does not apply to a health insurance policy that is
2689 subject to the Subscriber Assistance Program in s. 408.7056.
2690 Section 63. Effective May 1, 2012, section 627.6513,
2691 Florida Statutes, is created to read:
2692 627.6513 Section 641.312 and the provisions of the Employee
2693 Retirement Income Security Act of 1974, as implemented by 29
2694 C.F.R. s. 2560.503-1, relating to internal grievances, apply to
2695 all group health insurance policies issued under this part. This
2696 section does not apply to a group health insurance policy that
2697 is subject to the Subscriber Assistance Program in s. 408.7056.
2698 Section 64. Effective May 1, 2012, section 641.312, Florida
2699 Statutes, is created to read:
2700 641.312 The Office of Insurance Regulation within the
2701 Department of Financial Services shall adopt rules to administer
2702 the provisions of the National Association of Insurance
2703 Commissioners’ Uniform Health Carrier External Review Model Act,
2704 dated April 2010. This section does not apply to a health
2705 maintenance contract that is subject to the Subscriber
2706 Assistance Program in s. 408.7056.
2707 Section 65. Subsection (13) of section 651.118, Florida
2708 Statutes, is amended to read:
2709 651.118 Agency for Health Care Administration; certificates
2710 of need; sheltered beds; community beds.—
2711 (13) Residents, as defined in this chapter, are not
2712 considered new admissions for the purpose of s. 400 141(1)(n)1.d
2713 s. 400.141(1)(o)1.d.
2714 Section 66. In the interim between this act becoming law
2715 and the 2013 Regular Session of the Legislature, the Division of
2716 Statutory Revision shall provide the relevant substantive
2717 committees of the Senate and the House of Representatives with
2718 assistance, upon request, to enable such committees to prepare
2719 draft legislation to correct the names of accrediting
2720 organizations in the related Florida Statutes.
2721 Section 67. Except as otherwise expressly provided in this
2722 act, and except for this section, which shall take effect upon
2723 this act becoming a law, this act shall take effect July 1,
2724 2012.