Florida Senate - 2010 CS for CS for SB 2434
By the Policy and Steering Committee on Ways and Means; the
Committee on Health Regulation; and Senator Gardiner
576-05334-10 20102434c2
1 A bill to be entitled
2 An act relating to health care; amending s. 112.0455,
3 F.S., relating to the Drug-Free Workplace Act;
4 deleting an obsolete provision; amending s. 318.21,
5 F.S.; revising distribution of funds from civil
6 penalties imposed for traffic infractions by county
7 courts; amending s. 381.00315, F.S.; directing the
8 Department of Health to accept funds from counties,
9 municipalities, and certain other entities for the
10 purchase of certain products made available under a
11 contract of the United States Department of Health and
12 Human Services for the manufacture and delivery of
13 such products in response to a public health
14 emergency; amending s. 381.0072, F.S.; limiting
15 Department of Health food service inspections in
16 nursing homes; requiring the department to coordinate
17 inspections with the Agency for Health Care
18 Administration; amending s. 381.06014, F.S.; defining
19 the term “volunteer donor”; requiring that certain
20 blood establishments disclose specified information on
21 the Internet; repealing s. 383.325, F.S., relating to
22 confidentiality of inspection reports of licensed
23 birth center facilities; amending s. 395.002, F.S.;
24 revising and deleting definitions applicable to
25 regulation of hospitals and other licensed facilities;
26 conforming a cross-reference; amending s. 395.003,
27 F.S.; deleting an obsolete provision; conforming a
28 cross-reference; amending s. 395.0193, F.S.; requiring
29 a licensed facility to report certain peer review
30 information and final disciplinary actions to the
31 Division of Medical Quality Assurance of the
32 Department of Health rather than the Division of
33 Health Quality Assurance of the Agency for Health Care
34 Administration; amending s. 395.1023, F.S.; providing
35 for the Department of Children and Family Services
36 rather than the Department of Health to perform
37 certain functions with respect to child protection
38 cases; requiring certain hospitals to notify the
39 Department of Children and Family Services of
40 compliance; amending s. 395.1041, F.S., relating to
41 hospital emergency services and care; deleting
42 obsolete provisions; repealing s. 395.1046, F.S.,
43 relating to complaint investigation procedures;
44 amending s. 395.1055, F.S.; requiring licensed
45 facility beds to conform to standards specified by the
46 Agency for Health Care Administration, the Florida
47 Building Code, and the Florida Fire Prevention Code;
48 amending s. 395.10972, F.S.; revising a reference to
49 the Florida Society of Healthcare Risk Management to
50 conform to the current designation; amending s.
51 395.2050, F.S.; revising a reference to the federal
52 Health Care Financing Administration to conform to the
53 current designation; amending s. 395.3036, F.S.;
54 correcting a reference; repealing s. 395.3037, F.S.,
55 relating to redundant definitions; amending ss.
56 154.11, 394.741, 395.3038, 400.925, 400.9935, 408.05,
57 440.13, 627.645, 627.668, 627.669, 627.736, 641.495,
58 and 766.1015, F.S.; revising references to the Joint
59 Commission on Accreditation of Healthcare
60 Organizations, the Commission on Accreditation of
61 Rehabilitation Facilities, and the Council on
62 Accreditation to conform to their current
63 designations; amending s. 395.602, F.S.; revising the
64 definition of the term “rural hospital” to delete an
65 obsolete provision; amending s. 400.021, F.S.;
66 revising the definition of the term “geriatric
67 outpatient clinic”; amending s. 400.0255, F.S.;
68 correcting an obsolete cross-reference to
69 administrative rules; amending s. 400.063, F.S.;
70 deleting an obsolete provision; amending ss. 400.071
71 and 400.0712, F.S.; revising applicability of general
72 licensure requirements under part II of ch. 408, F.S.,
73 to applications for nursing home licensure; revising
74 provisions governing inactive licenses; amending s.
75 400.111, F.S.; providing for disclosure of controlling
76 interest of a nursing home facility upon request by
77 the Agency for Health Care Administration; amending s.
78 400.1183, F.S.; revising grievance record maintenance
79 and reporting requirements for nursing homes; amending
80 s. 400.141, F.S.; providing criteria for the provision
81 of respite services by nursing homes; requiring a
82 written plan of care; requiring a contract for
83 services; requiring resident release to caregivers to
84 be designated in writing; providing an exemption to
85 the application of discharge planning rules; providing
86 for residents’ rights; providing for use of personal
87 medications; providing terms of respite stay;
88 providing for communication of patient information;
89 requiring a physician order for care and proof of a
90 physical examination; providing for services for
91 respite patients and duties of facilities with respect
92 to such patients; conforming a cross-reference;
93 requiring facilities to maintain clinical records that
94 meet specified standards; providing a fine relating to
95 an admissions moratorium; deleting requirement for
96 facilities to submit certain information related to
97 management companies to the agency; deleting a
98 requirement for facilities to notify the agency of
99 certain bankruptcy filings to conform to changes made
100 by the act; amending s. 400.142, F.S.; deleting
101 language relating to agency adoption of rules;
102 amending 400.147, F.S.; revising reporting
103 requirements for licensed nursing home facilities
104 relating to adverse incidents; repealing s. 400.148,
105 F.S., relating to the Medicaid “Up-or-Out” Quality of
106 Care Contract Management Program; amending s. 400.162,
107 F.S., requiring nursing homes to provide a resident
108 property statement annually and upon request; amending
109 s. 400.179, F.S.; revising requirements for nursing
110 home lease bond alternative fees; deleting an obsolete
111 provision; amending s. 400.19, F.S.; revising
112 inspection requirements; repealing s. 400.195, F.S.,
113 relating to agency reporting requirements; amending s.
114 400.23, F.S.; deleting an obsolete provision;
115 correcting a reference; directing the agency to adopt
116 rules for minimum staffing standards in nursing homes
117 that serve persons under 21 years of age; providing
118 minimum staffing standards; amending s. 400.275, F.S.;
119 revising agency duties with regard to training nursing
120 home surveyor teams; revising requirements for team
121 members; amending s. 400.484, F.S.; revising the
122 schedule of home health agency inspection violations;
123 amending s. 400.606, F.S.; revising the content
124 requirements of the plan accompanying an initial or
125 change-of-ownership application for licensure of a
126 hospice; revising requirements relating to
127 certificates of need for certain hospice facilities;
128 amending s. 400.607, F.S.; revising grounds for agency
129 action against a hospice; amending s. 400.915, F.S.;
130 correcting an obsolete cross-reference to
131 administrative rules; amending s. 400.931, F.S.;
132 deleting a requirement that an applicant for a home
133 medical equipment provider license submit a surety
134 bond to the agency; amending s. 400.932, F.S.;
135 revising grounds for the imposition of administrative
136 penalties for certain violations by an employee of a
137 home medical equipment provider; amending s. 400.967,
138 F.S.; revising the schedule of inspection violations
139 for intermediate care facilities for the
140 developmentally disabled; providing a penalty for
141 certain violations; amending s. 400.9905, F.S.;
142 providing that part X of ch, 400, F.S., the Health
143 Care Clinic Act, does not apply to an entity owned by
144 a corporation with a specified amount of annual sales
145 of health care services under certain circumstances or
146 to an entity owned or controlled by a publicly traded
147 entity with a specified amount of annual revenues;
148 amending s. 400.991, F.S.; conforming terminology;
149 revising application requirements relating to
150 documentation of financial ability to operate a mobile
151 clinic; amending s. 408.034, F.S.; revising agency
152 authority relating to licensing of intermediate care
153 facilities for the developmentally disabled; amending
154 s. 408.036, F.S.; deleting an exemption from certain
155 certificate-of-need review requirements for a hospice
156 or a hospice inpatient facility; amending s. 408.043,
157 F.S.; revising requirements for certain freestanding
158 inpatient hospice care facilities to obtain a
159 certificate of need; amending s. 408.061, F.S.;
160 revising health care facility data reporting
161 requirements; amending s. 408.10, F.S.; removing
162 agency authority to investigate certain consumer
163 complaints; amending s. 408.802, F.S.; removing
164 applicability of part II of ch. 408, F.S., relating to
165 general licensure requirements, to private review
166 agents; amending s. 408.804, F.S.; providing penalties
167 for altering, defacing, or falsifying a license
168 certificate issued by the agency or displaying such an
169 altered, defaced, or falsified certificate; amending
170 s. 408.806, F.S.; revising agency responsibilities for
171 notification of licensees of impending expiration of a
172 license; requiring payment of a late fee for a license
173 application to be considered complete under certain
174 circumstances; amending s. 408.810, F.S.; revising
175 provisions relating to information required for
176 licensure; requiring proof of submission of notice to
177 a mortgagor or landlord regarding provision of
178 services requiring licensure; requiring disclosure of
179 information by a controlling interest of certain court
180 actions relating to financial instability within a
181 specified time period; amending s. 408.813, F.S.;
182 authorizing the agency to impose fines for
183 unclassified violations of part II of ch. 408, F.S.;
184 amending s. 408.815, F.S.; authorizing the agency to
185 extend a license expiration date under certain
186 circumstances; amending s. 409.221, F.S.; deleting a
187 reporting requirement relating to the consumer
188 directed care program; amending s. 409.91196, F.S.;
189 conforming a cross-reference; amending s. 409.912,
190 F.S.; revising procedures for implementation of a
191 Medicaid prescribed-drug spending-control program;
192 amending s. 429.07, F.S.; deleting the requirement for
193 an assisted living facility to obtain an additional
194 license in order to provide limited nursing services;
195 deleting the requirement for the agency to conduct
196 quarterly monitoring visits of facilities that hold a
197 license to provide extended congregate care services;
198 deleting the requirement for the department to report
199 annually on the status of and recommendations related
200 to extended congregate care; deleting the requirement
201 for the agency to conduct monitoring visits at least
202 twice a year to facilities providing limited nursing
203 services; increasing the licensure fees and the
204 maximum fee required for the standard license;
205 increasing the licensure fees for the extended
206 congregate care license; eliminating the license fee
207 for the limited nursing services license; transferring
208 from another provision of law the requirement that a
209 biennial survey of an assisted living facility include
210 specific actions to determine whether the facility is
211 adequately protecting residents’ rights; providing
212 that an assisted living facility that has a class I or
213 class II violation is subject to monitoring visits;
214 requiring a registered nurse to participate in certain
215 monitoring visits; amending s. 429.11, F.S.; revising
216 licensure application requirements for assisted living
217 facilities to eliminate provisional licenses; amending
218 s. 429.12, F.S.; revising notification requirements
219 for the sale or transfer of ownership of an assisted
220 living facility; amending s. 429.14, F.S.; removing a
221 ground for the imposition of an administrative
222 penalty; clarifying provisions relating to a
223 facility’s request for a hearing under certain
224 circumstances; authorizing the agency to provide
225 certain information relating to the licensure status
226 of assisted living facilities electronically or
227 through the agency’s Internet website; amending s.
228 429.17, F.S.; deleting provisions relating to the
229 limited nursing services license; revising agency
230 responsibilities regarding the issuance of conditional
231 licenses; amending s. 429.19, F.S.; clarifying that a
232 monitoring fee may be assessed in addition to an
233 administrative fine; amending s. 429.23, F.S.;
234 deleting reporting requirements for assisted living
235 facilities relating to liability claims; amending s.
236 429.255, F.S.; eliminating provisions authorizing the
237 use of volunteers to provide certain health-care
238 related services in assisted living facilities;
239 authorizing assisted living facilities to provide
240 limited nursing services; requiring an assisted living
241 facility to be responsible for certain recordkeeping
242 and staff to be trained to monitor residents receiving
243 certain health-care-related services; amending s.
244 429.28, F.S.; deleting a requirement for a biennial
245 survey of an assisted living facility, to conform to
246 changes made by the act; amending s. 429.35, F.S.;
247 authorizing the agency to provide certain information
248 relating to the inspections of assisted living
249 facilities electronically or through the agency’s
250 Internet website; amending s. 429.41, F.S., relating
251 to rulemaking; conforming provisions to changes made
252 by the act; amending s. 429.53, F.S.; revising
253 provisions relating to consultation by the agency;
254 revising a definition; amending s. 429.54, F.S.;
255 requiring licensed assisted living facilities to
256 electronically report certain data semiannually to the
257 agency in accordance with rules adopted by the
258 department; amending s. 429.71, F.S.; revising
259 schedule of inspection violations for adult family
260 care homes; amending s. 429.911, F.S.; deleting a
261 ground for agency action against an adult day care
262 center; amending s. 429.915, F.S.; revising agency
263 responsibilities regarding the issuance of conditional
264 licenses; amending s. 483.201, F.S.; providing for
265 disciplinary action against clinical laboratories
266 failing to disclose specified information on the
267 Internet; providing a maximum annual administrative
268 fine that may be imposed annually against certain
269 clinical laboratories for failure to comply with such
270 disclosure requirement; amending s. 483.294, F.S.;
271 revising frequency of agency inspections of
272 multiphasic health testing centers; amending s.
273 499.003, F.S.; revising the definition of the term
274 “health care entity” to clarify that a blood
275 establishment may be a health care entity and engage
276 in certain activities; removing a requirement that
277 certain prescription drug purchasers maintain a
278 separate inventory of certain prescription drugs;
279 amending s. 499.005, F.S.; clarifying provisions
280 prohibiting the unauthorized wholesale distribution of
281 a prescription drug that was purchased by a hospital
282 or other health care entity, to conform to changes
283 made by the act; amending s. 499.01, F.S.; exempting
284 certain blood establishments from the requirements to
285 be permitted as a prescription drug manufacturer and
286 register products; requiring that certain blood
287 establishments obtain a restricted prescription drug
288 distributor permit under specified conditions;
289 limiting the prescription drugs that a blood
290 establishment may distribute with the restricted
291 prescription drug distributor permit; authorizing the
292 Department of Health to adopt rules; amending s.
293 499.01212, F.S.; exempting prescription drugs
294 contained in sealed medical convenience kits from the
295 pedigree paper requirements under specified
296 circumstances; amending s. 633.081, F.S.; limiting
297 Fire Marshal inspections of nursing homes to once a
298 year; providing for additional inspections based on
299 complaints and violations identified in the course of
300 orientation or training activities; amending s.
301 766.202, F.S.; adding persons licensed under part XIV
302 of ch. 468, F.S., to the definition of “health care
303 provider”; amending ss. 394.4787, 400.0239, 408.07,
304 430.80, and 651.118, F.S.; conforming terminology and
305 cross-references; revising a reference; providing an
306 effective date.
307
308 Be It Enacted by the Legislature of the State of Florida:
309
310 Section 1. Present paragraph (e) of subsection (10) and
311 paragraph (e) of subsection (14) of section 112.0455, Florida
312 Statutes, are amended, and paragraphs (f) through (k) of
313 subsection (10) of that section are redesignated as paragraphs
314 (e) through (j), respectively, to read:
315 112.0455 Drug-Free Workplace Act.—
316 (10) EMPLOYER PROTECTION.—
317 (e) Nothing in this section shall be construed to operate
318 retroactively, and nothing in this section shall abrogate the
319 right of an employer under state law to conduct drug tests prior
320 to January 1, 1990. A drug test conducted by an employer prior
321 to January 1, 1990, is not subject to this section.
322 (14) DISCIPLINE REMEDIES.—
323 (e) Upon resolving an appeal filed pursuant to paragraph
324 (c), and finding a violation of this section, the commission may
325 order the following relief:
326 1. Rescind the disciplinary action, expunge related records
327 from the personnel file of the employee or job applicant and
328 reinstate the employee.
329 2. Order compliance with paragraph (10)(f)(g).
330 3. Award back pay and benefits.
331 4. Award the prevailing employee or job applicant the
332 necessary costs of the appeal, reasonable attorney’s fees, and
333 expert witness fees.
334 Section 2. Paragraph (n) of subsection (1) of section
335 154.11, Florida Statutes, is amended to read:
336 154.11 Powers of board of trustees.—
337 (1) The board of trustees of each public health trust shall
338 be deemed to exercise a public and essential governmental
339 function of both the state and the county and in furtherance
340 thereof it shall, subject to limitation by the governing body of
341 the county in which such board is located, have all of the
342 powers necessary or convenient to carry out the operation and
343 governance of designated health care facilities, including, but
344 without limiting the generality of, the foregoing:
345 (n) To appoint originally the staff of physicians to
346 practice in any designated facility owned or operated by the
347 board and to approve the bylaws and rules to be adopted by the
348 medical staff of any designated facility owned and operated by
349 the board, such governing regulations to be in accordance with
350 the standards of The Joint Commission on the Accreditation of
351 Hospitals which provide, among other things, for the method of
352 appointing additional staff members and for the removal of staff
353 members.
354 Section 3. Subsection (15) of section 318.21, Florida
355 Statutes, is amended to read:
356 318.21 Disposition of civil penalties by county courts.—All
357 civil penalties received by a county court pursuant to the
358 provisions of this chapter shall be distributed and paid monthly
359 as follows:
360 (15) Of the additional fine assessed under s. 318.18(3)(e)
361 for a violation of s. 316.1893, 50 percent of the moneys
362 received from the fines shall be remitted to the Department of
363 Revenue and deposited into the Brain and Spinal Cord Injury
364 Trust Fund of Department of Health and shall be appropriated to
365 the Department of Health Agency for Health Care Administration
366 as general revenue to provide an enhanced Medicaid payment to
367 nursing homes that serve Medicaid recipients with spinal cord
368 injuries that are medically complex and who are technologically
369 and respiratory dependent with brain and spinal cord injuries.
370 The remaining 50 percent of the moneys received from the
371 enhanced fine imposed under s. 318.18(3)(e) shall be remitted to
372 the Department of Revenue and deposited into the Department of
373 Health Administrative Trust Fund to provide financial support to
374 certified trauma centers in the counties where enhanced penalty
375 zones are established to ensure the availability and
376 accessibility of trauma services. Funds deposited into the
377 Administrative Trust Fund under this subsection shall be
378 allocated as follows:
379 (a) Fifty percent shall be allocated equally among all
380 Level I, Level II, and pediatric trauma centers in recognition
381 of readiness costs for maintaining trauma services.
382 (b) Fifty percent shall be allocated among Level I, Level
383 II, and pediatric trauma centers based on each center’s relative
384 volume of trauma cases as reported in the Department of Health
385 Trauma Registry.
386 Section 4. Subsection (3) is added to section 381.00315,
387 Florida Statutes, to read:
388 381.00315 Public health advisories; public health
389 emergencies.—The State Health Officer is responsible for
390 declaring public health emergencies and issuing public health
391 advisories.
392 (3) To facilitate effective emergency management, when the
393 United States Department of Health and Human Services contracts
394 for the manufacture and delivery of licensable products in
395 response to a public health emergency and the terms of those
396 contracts are made available to the states, the department shall
397 accept funds provided by counties, municipalities, and other
398 entities designated in the state emergency management plan
399 required under s. 252.35(2)(a) for the purpose of participation
400 in such contracts. The department shall deposit the funds into
401 the Grants and Donations Trust Fund and expend the funds on
402 behalf of the donor county, municipality, or other entity for
403 the purchase the licensable products made available under the
404 contract.
405 Section 5. Paragraph (e) is added to subsection (2) of
406 section 381.0072, Florida Statutes, to read:
407 381.0072 Food service protection.—It shall be the duty of
408 the Department of Health to adopt and enforce sanitation rules
409 consistent with law to ensure the protection of the public from
410 food-borne illness. These rules shall provide the standards and
411 requirements for the storage, preparation, serving, or display
412 of food in food service establishments as defined in this
413 section and which are not permitted or licensed under chapter
414 500 or chapter 509.
415 (2) DUTIES.—
416 (e) The department shall inspect food service
417 establishments in nursing homes licensed under part II of
418 chapter 400 twice each year. The department may make additional
419 inspections only in response to complaints. The department shall
420 coordinate inspections with the Agency for Health Care
421 Administration, such that the department’s inspection is at
422 least 60 days after a recertification visit by the Agency for
423 Health Care Administration.
424 Section 6. Section 381.06014, Florida Statutes, is amended
425 to read:
426 381.06014 Blood establishments.—
427 (1) As used in this section, the term:
428 (a) “Blood establishment” means any person, entity, or
429 organization, operating within the state, which examines an
430 individual for the purpose of blood donation or which collects,
431 processes, stores, tests, or distributes blood or blood
432 components collected from the human body for the purpose of
433 transfusion, for any other medical purpose, or for the
434 production of any biological product.
435 (b) “Volunteer donor” means a person who does not receive
436 remuneration, other than an incentive, for a blood donation
437 intended for transfusion, and the product container of the
438 donation from the person qualifies for labeling with the
439 statement “volunteer donor” under 21 C.F.R. 606.121.
440 (2) Any blood establishment operating in the state may not
441 conduct any activity defined in subsection (1) unless that blood
442 establishment is operated in a manner consistent with the
443 provisions of Title 21 parts 211 and 600-640, Code of Federal
444 Regulations.
445 (3) Any blood establishment determined to be operating in
446 the state in a manner not consistent with the provisions of
447 Title 21 parts 211 and 600-640, Code of Federal Regulations, and
448 in a manner that constitutes a danger to the health or well
449 being of donors or recipients as evidenced by the federal Food
450 and Drug Administration’s inspection reports and the revocation
451 of the blood establishment’s license or registration shall be in
452 violation of this chapter and shall immediately cease all
453 operations in the state.
454 (4) The operation of a blood establishment in a manner not
455 consistent with the provisions of Title 21 parts 211 and 600
456 640, Code of Federal Regulations, and in a manner that
457 constitutes a danger to the health or well-being of blood donors
458 or recipients as evidenced by the federal Food and Drug
459 Administration’s inspection process is declared a nuisance and
460 inimical to the public health, welfare, and safety. The Agency
461 for Health Care Administration or any state attorney may bring
462 an action for an injunction to restrain such operations or
463 enjoin the future operation of the blood establishment.
464 (5) A blood establishment that collects blood or blood
465 components from volunteer donors must disclose on the Internet
466 information to educate and inform donors and the public about
467 the blood establishment’s activities. A hospital that collects
468 blood or blood components from volunteer donors for its own use
469 or for health care providers that are part of its business
470 entity is exempt from the disclosure requirements in this
471 subsection. The information required to be disclosed under this
472 subsection may be cumulative for all blood establishments within
473 a business entity. Disciplinary action against the blood
474 establishment’s clinical laboratory license may be taken as
475 provided in s. 483.201 for a blood establishment that is
476 required to disclose but fails to disclose on its website all of
477 the following information:
478 (a) A description of the steps involved in collecting,
479 processing, and distributing volunteer donations, presented in a
480 manner appropriate for the donating public.
481 (b) By March 1 of each year, the number of units of blood
482 components, identified by component, that were:
483 1. Produced by the blood establishment during the preceding
484 calendar year;
485 2. Obtained from other sources during the preceding
486 calendar year;
487 3. Distributed during the preceding year to health care
488 providers located outside this state. However, if the blood
489 establishment collects donations in a county outside this state,
490 distributions to health care providers in that county shall be
491 excluded. Such information shall be aggregated by health care
492 providers located within the United States and its territories
493 or outside the United States and its territories; and
494 4. Distributed to entities that are not health care
495 providers during the preceding year. Such information shall be
496 aggregated by purchasers located within the United States and
497 its territories or outside the United States and its
498 territories.
499
500 For purposes of this paragraph, the components that must be
501 reported include whole blood, red blood cells, leukoreduced red
502 blood cells, fresh frozen plasma or the equivalent, recovered
503 plasma, platelets, and cryoprecipitated antihemophilic factor.
504 (c) The blood establishment’s conflict-of-interest policy,
505 policy concerning related-party transactions, whistleblower
506 policy, and policy for determining executive compensation. If a
507 change to any of these documents occurs, the revised document
508 must be available on the blood establishment’s website by the
509 following March 1.
510 (d)1. The most recent 3 years of the Return of Organization
511 Exempt from Income Tax, Internal Revenue Service Form 990, if
512 the business entity for the blood establishment is eligible to
513 file such return. The Form 990 must be available on the blood
514 establishment’s website within 30 calendar days after filing it
515 with the Internal Revenue Service; or
516 2. If the business entity for the blood establishment is
517 not eligible to file the Form 990 return, a balance sheet,
518 income statement, statement of changes in cash flow, and the
519 expression of an opinion thereon by an independent certified
520 public accountant who audited or reviewed such financial
521 statements. Such documents must be available on the blood
522 establishment’s website within 120 days after the end of the
523 blood establishment’s fiscal year and must remain on the blood
524 establishment’s website for at least 36 months.
525 Section 7. Section 383.325, Florida Statutes, is repealed.
526 Section 8. Subsection (7) of section 394.4787, Florida
527 Statutes, is amended to read:
528 394.4787 Definitions; ss. 394.4786, 394.4787, 394.4788, and
529 394.4789.—As used in this section and ss. 394.4786, 394.4788,
530 and 394.4789:
531 (7) “Specialty psychiatric hospital” means a hospital
532 licensed by the agency pursuant to s. 395.002(26)(28) and part
533 II of chapter 408 as a specialty psychiatric hospital.
534 Section 9. Subsection (2) of section 394.741, Florida
535 Statutes, is amended to read:
536 394.741 Accreditation requirements for providers of
537 behavioral health care services.—
538 (2) Notwithstanding any provision of law to the contrary,
539 accreditation shall be accepted by the agency and department in
540 lieu of the agency’s and department’s facility licensure onsite
541 review requirements and shall be accepted as a substitute for
542 the department’s administrative and program monitoring
543 requirements, except as required by subsections (3) and (4),
544 for:
545 (a) Any organization from which the department purchases
546 behavioral health care services that is accredited by The Joint
547 Commission on Accreditation of Healthcare Organizations or the
548 Council on Accreditation for Children and Family Services, or
549 has those services that are being purchased by the department
550 accredited by the Commission on Accreditation of Rehabilitation
551 Facilities CARF—the Rehabilitation Accreditation Commission.
552 (b) Any mental health facility licensed by the agency or
553 any substance abuse component licensed by the department that is
554 accredited by The Joint Commission on Accreditation of
555 Healthcare Organizations, the Commission on Accreditation of
556 Rehabilitation Facilities CARF—the Rehabilitation Accreditation
557 Commission, or the Council on Accreditation of Children and
558 Family Services.
559 (c) Any network of providers from which the department or
560 the agency purchases behavioral health care services accredited
561 by The Joint Commission on Accreditation of Healthcare
562 Organizations, the Commission on Accreditation of Rehabilitation
563 Facilities CARF—the Rehabilitation Accreditation Commission, the
564 Council on Accreditation of Children and Family Services, or the
565 National Committee for Quality Assurance. A provider
566 organization, which is part of an accredited network, is
567 afforded the same rights under this part.
568 Section 10. Present subsections (15) through (32) of
569 section 395.002, Florida Statutes, are renumbered as subsections
570 (14) through (28), respectively, and present subsections (1),
571 (14), (24), (30), and (31), and paragraph (c) of present
572 subsection (28) of that section are amended to read:
573 395.002 Definitions.—As used in this chapter:
574 (1) “Accrediting organizations” means nationally recognized
575 or approved accrediting organizations whose standards
576 incorporate comparable licensure requirements as determined by
577 the agency the Joint Commission on Accreditation of Healthcare
578 Organizations, the American Osteopathic Association, the
579 Commission on Accreditation of Rehabilitation Facilities, and
580 the Accreditation Association for Ambulatory Health Care, Inc.
581 (14) “Initial denial determination” means a determination
582 by a private review agent that the health care services
583 furnished or proposed to be furnished to a patient are
584 inappropriate, not medically necessary, or not reasonable.
585 (24) “Private review agent” means any person or entity
586 which performs utilization review services for third-party
587 payors on a contractual basis for outpatient or inpatient
588 services. However, the term shall not include full-time
589 employees, personnel, or staff of health insurers, health
590 maintenance organizations, or hospitals, or wholly owned
591 subsidiaries thereof or affiliates under common ownership, when
592 performing utilization review for their respective hospitals,
593 health maintenance organizations, or insureds of the same
594 insurance group. For this purpose, health insurers, health
595 maintenance organizations, and hospitals, or wholly owned
596 subsidiaries thereof or affiliates under common ownership,
597 include such entities engaged as administrators of self
598 insurance as defined in s. 624.031.
599 (26)(28) “Specialty hospital” means any facility which
600 meets the provisions of subsection (12), and which regularly
601 makes available either:
602 (c) Intensive residential treatment programs for children
603 and adolescents as defined in subsection (14) (15).
604 (30) “Utilization review” means a system for reviewing the
605 medical necessity or appropriateness in the allocation of health
606 care resources of hospital services given or proposed to be
607 given to a patient or group of patients.
608 (31) “Utilization review plan” means a description of the
609 policies and procedures governing utilization review activities
610 performed by a private review agent.
611 Section 11. Paragraph (c) of subsection (1) and paragraph
612 (b) of subsection (2) of section 395.003, Florida Statutes, are
613 amended to read:
614 395.003 Licensure; denial, suspension, and revocation.—
615 (1)
616 (c) Until July 1, 2006, additional emergency departments
617 located off the premises of licensed hospitals may not be
618 authorized by the agency.
619 (2)
620 (b) The agency shall, at the request of a licensee that is
621 a teaching hospital as defined in s. 408.07(45), issue a single
622 license to a licensee for facilities that have been previously
623 licensed as separate premises, provided such separately licensed
624 facilities, taken together, constitute the same premises as
625 defined in s. 395.002(22)(23). Such license for the single
626 premises shall include all of the beds, services, and programs
627 that were previously included on the licenses for the separate
628 premises. The granting of a single license under this paragraph
629 shall not in any manner reduce the number of beds, services, or
630 programs operated by the licensee.
631 Section 12. Paragraph (e) of subsection (2) and subsection
632 (4) of section 395.0193, Florida Statutes, are amended to read:
633 395.0193 Licensed facilities; peer review; disciplinary
634 powers; agency or partnership with physicians.—
635 (2) Each licensed facility, as a condition of licensure,
636 shall provide for peer review of physicians who deliver health
637 care services at the facility. Each licensed facility shall
638 develop written, binding procedures by which such peer review
639 shall be conducted. Such procedures shall include:
640 (e) Recording of agendas and minutes which do not contain
641 confidential material, for review by the Division of Medical
642 Quality Assurance of the department Health Quality Assurance of
643 the agency.
644 (4) Pursuant to ss. 458.337 and 459.016, any disciplinary
645 actions taken under subsection (3) shall be reported in writing
646 to the Division of Medical Quality Assurance of the department
647 Health Quality Assurance of the agency within 30 working days
648 after its initial occurrence, regardless of the pendency of
649 appeals to the governing board of the hospital. The notification
650 shall identify the disciplined practitioner, the action taken,
651 and the reason for such action. All final disciplinary actions
652 taken under subsection (3), if different from those which were
653 reported to the department agency within 30 days after the
654 initial occurrence, shall be reported within 10 working days to
655 the Division of Medical Quality Assurance of the department
656 Health Quality Assurance of the agency in writing and shall
657 specify the disciplinary action taken and the specific grounds
658 therefor. The division shall review each report and determine
659 whether it potentially involved conduct by the licensee that is
660 subject to disciplinary action, in which case s. 456.073 shall
661 apply. The reports are not subject to inspection under s.
662 119.07(1) even if the division’s investigation results in a
663 finding of probable cause.
664 Section 13. Section 395.1023, Florida Statutes, is amended
665 to read:
666 395.1023 Child abuse and neglect cases; duties.—Each
667 licensed facility shall adopt a protocol that, at a minimum,
668 requires the facility to:
669 (1) Incorporate a facility policy that every staff member
670 has an affirmative duty to report, pursuant to chapter 39, any
671 actual or suspected case of child abuse, abandonment, or
672 neglect; and
673 (2) In any case involving suspected child abuse,
674 abandonment, or neglect, designate, at the request of the
675 Department of Children and Family Services, a staff physician to
676 act as a liaison between the hospital and the Department of
677 Children and Family Services office which is investigating the
678 suspected abuse, abandonment, or neglect, and the child
679 protection team, as defined in s. 39.01, when the case is
680 referred to such a team.
681
682 Each general hospital and appropriate specialty hospital shall
683 comply with the provisions of this section and shall notify the
684 agency and the Department of Children and Family Services of its
685 compliance by sending a copy of its policy to the agency and the
686 Department of Children and Family Services as required by rule.
687 The failure by a general hospital or appropriate specialty
688 hospital to comply shall be punished by a fine not exceeding
689 $1,000, to be fixed, imposed, and collected by the agency. Each
690 day in violation is considered a separate offense.
691 Section 14. Subsection (2) and paragraph (d) of subsection
692 (3) of section 395.1041, Florida Statutes, are amended to read:
693 395.1041 Access to emergency services and care.—
694 (2) INVENTORY OF HOSPITAL EMERGENCY SERVICES.—The agency
695 shall establish and maintain an inventory of hospitals with
696 emergency services. The inventory shall list all services within
697 the service capability of the hospital, and such services shall
698 appear on the face of the hospital license. Each hospital having
699 emergency services shall notify the agency of its service
700 capability in the manner and form prescribed by the agency. The
701 agency shall use the inventory to assist emergency medical
702 services providers and others in locating appropriate emergency
703 medical care. The inventory shall also be made available to the
704 general public. On or before August 1, 1992, the agency shall
705 request that each hospital identify the services which are
706 within its service capability. On or before November 1, 1992,
707 the agency shall notify each hospital of the service capability
708 to be included in the inventory. The hospital has 15 days from
709 the date of receipt to respond to the notice. By December 1,
710 1992, the agency shall publish a final inventory. Each hospital
711 shall reaffirm its service capability when its license is
712 renewed and shall notify the agency of the addition of a new
713 service or the termination of a service prior to a change in its
714 service capability.
715 (3) EMERGENCY SERVICES; DISCRIMINATION; LIABILITY OF
716 FACILITY OR HEALTH CARE PERSONNEL.—
717 (d)1. Every hospital shall ensure the provision of services
718 within the service capability of the hospital, at all times,
719 either directly or indirectly through an arrangement with
720 another hospital, through an arrangement with one or more
721 physicians, or as otherwise made through prior arrangements. A
722 hospital may enter into an agreement with another hospital for
723 purposes of meeting its service capability requirement, and
724 appropriate compensation or other reasonable conditions may be
725 negotiated for these backup services.
726 2. If any arrangement requires the provision of emergency
727 medical transportation, such arrangement must be made in
728 consultation with the applicable provider and may not require
729 the emergency medical service provider to provide transportation
730 that is outside the routine service area of that provider or in
731 a manner that impairs the ability of the emergency medical
732 service provider to timely respond to prehospital emergency
733 calls.
734 3. A hospital shall not be required to ensure service
735 capability at all times as required in subparagraph 1. if, prior
736 to the receiving of any patient needing such service capability,
737 such hospital has demonstrated to the agency that it lacks the
738 ability to ensure such capability and it has exhausted all
739 reasonable efforts to ensure such capability through backup
740 arrangements. In reviewing a hospital’s demonstration of lack of
741 ability to ensure service capability, the agency shall consider
742 factors relevant to the particular case, including the
743 following:
744 a. Number and proximity of hospitals with the same service
745 capability.
746 b. Number, type, credentials, and privileges of
747 specialists.
748 c. Frequency of procedures.
749 d. Size of hospital.
750 4. The agency shall publish proposed rules implementing a
751 reasonable exemption procedure by November 1, 1992. Subparagraph
752 1. shall become effective upon the effective date of said rules
753 or January 31, 1993, whichever is earlier. For a period not to
754 exceed 1 year from the effective date of subparagraph 1., a
755 hospital requesting an exemption shall be deemed to be exempt
756 from offering the service until the agency initially acts to
757 deny or grant the original request. The agency has 45 days from
758 the date of receipt of the request to approve or deny the
759 request. After the first year from the effective date of
760 subparagraph 1., If the agency fails to initially act within the
761 time period, the hospital is deemed to be exempt from offering
762 the service until the agency initially acts to deny the request.
763 Section 15. Section 395.1046, Florida Statutes, is
764 repealed.
765 Section 16. Paragraph (e) of subsection (1) of section
766 395.1055, Florida Statutes, is amended to read:
767 395.1055 Rules and enforcement.—
768 (1) The agency shall adopt rules pursuant to ss. 120.536(1)
769 and 120.54 to implement the provisions of this part, which shall
770 include reasonable and fair minimum standards for ensuring that:
771 (e) Licensed facility beds conform to minimum space,
772 equipment, and furnishings standards as specified by the agency,
773 the Florida Building Code, and the Florida Fire Prevention Code
774 department.
775 Section 17. Subsection (1) of section 395.10972, Florida
776 Statutes, is amended to read:
777 395.10972 Health Care Risk Manager Advisory Council.—The
778 Secretary of Health Care Administration may appoint a seven
779 member advisory council to advise the agency on matters
780 pertaining to health care risk managers. The members of the
781 council shall serve at the pleasure of the secretary. The
782 council shall designate a chair. The council shall meet at the
783 call of the secretary or at those times as may be required by
784 rule of the agency. The members of the advisory council shall
785 receive no compensation for their services, but shall be
786 reimbursed for travel expenses as provided in s. 112.061. The
787 council shall consist of individuals representing the following
788 areas:
789 (1) Two shall be active health care risk managers,
790 including one risk manager who is recommended by and a member of
791 the Florida Society for of Healthcare Risk Management and
792 Patient Safety.
793 Section 18. Subsection (3) of section 395.2050, Florida
794 Statutes, is amended to read:
795 395.2050 Routine inquiry for organ and tissue donation;
796 certification for procurement activities; death records review.—
797 (3) Each organ procurement organization designated by the
798 federal Centers for Medicare and Medicaid Services Health Care
799 Financing Administration and licensed by the state shall conduct
800 an annual death records review in the organ procurement
801 organization’s affiliated donor hospitals. The organ procurement
802 organization shall enlist the services of every Florida licensed
803 tissue bank and eye bank affiliated with or providing service to
804 the donor hospital and operating in the same service area to
805 participate in the death records review.
806 Section 19. Subsection (2) of section 395.3036, Florida
807 Statutes, is amended to read:
808 395.3036 Confidentiality of records and meetings of
809 corporations that lease public hospitals or other public health
810 care facilities.—The records of a private corporation that
811 leases a public hospital or other public health care facility
812 are confidential and exempt from the provisions of s. 119.07(1)
813 and s. 24(a), Art. I of the State Constitution, and the meetings
814 of the governing board of a private corporation are exempt from
815 s. 286.011 and s. 24(b), Art. I of the State Constitution when
816 the public lessor complies with the public finance
817 accountability provisions of s. 155.40(5) with respect to the
818 transfer of any public funds to the private lessee and when the
819 private lessee meets at least three of the five following
820 criteria:
821 (2) The public lessor and the private lessee do not
822 commingle any of their funds in any account maintained by either
823 of them, other than the payment of the rent and administrative
824 fees or the transfer of funds pursuant to s. 155.40(2)
825 subsection (2).
826 Section 20. Section 395.3037, Florida Statutes, is
827 repealed.
828 Section 21. Subsections (1), (4), and (5) of section
829 395.3038, Florida Statutes, are amended to read:
830 395.3038 State-listed primary stroke centers and
831 comprehensive stroke centers; notification of hospitals.—
832 (1) The agency shall make available on its website and to
833 the department a list of the name and address of each hospital
834 that meets the criteria for a primary stroke center and the name
835 and address of each hospital that meets the criteria for a
836 comprehensive stroke center. The list of primary and
837 comprehensive stroke centers shall include only those hospitals
838 that attest in an affidavit submitted to the agency that the
839 hospital meets the named criteria, or those hospitals that
840 attest in an affidavit submitted to the agency that the hospital
841 is certified as a primary or a comprehensive stroke center by
842 The Joint Commission on Accreditation of Healthcare
843 Organizations.
844 (4) The agency shall adopt by rule criteria for a primary
845 stroke center which are substantially similar to the
846 certification standards for primary stroke centers of The Joint
847 Commission on Accreditation of Healthcare Organizations.
848 (5) The agency shall adopt by rule criteria for a
849 comprehensive stroke center. However, if The Joint Commission on
850 Accreditation of Healthcare Organizations establishes criteria
851 for a comprehensive stroke center, the agency shall establish
852 criteria for a comprehensive stroke center which are
853 substantially similar to those criteria established by The Joint
854 Commission on Accreditation of Healthcare Organizations.
855 Section 22. Paragraph (e) of subsection (2) of section
856 395.602, Florida Statutes, is amended to read:
857 395.602 Rural hospitals.—
858 (2) DEFINITIONS.—As used in this part:
859 (e) “Rural hospital” means an acute care hospital licensed
860 under this chapter, having 100 or fewer licensed beds and an
861 emergency room, which is:
862 1. The sole provider within a county with a population
863 density of no greater than 100 persons per square mile;
864 2. An acute care hospital, in a county with a population
865 density of no greater than 100 persons per square mile, which is
866 at least 30 minutes of travel time, on normally traveled roads
867 under normal traffic conditions, from any other acute care
868 hospital within the same county;
869 3. A hospital supported by a tax district or subdistrict
870 whose boundaries encompass a population of 100 persons or fewer
871 per square mile;
872 4. A hospital in a constitutional charter county with a
873 population of over 1 million persons that has imposed a local
874 option health service tax pursuant to law and in an area that
875 was directly impacted by a catastrophic event on August 24,
876 1992, for which the Governor of Florida declared a state of
877 emergency pursuant to chapter 125, and has 120 beds or less that
878 serves an agricultural community with an emergency room
879 utilization of no less than 20,000 visits and a Medicaid
880 inpatient utilization rate greater than 15 percent;
881 4.5. A hospital with a service area that has a population
882 of 100 persons or fewer per square mile. As used in this
883 subparagraph, the term “service area” means the fewest number of
884 zip codes that account for 75 percent of the hospital’s
885 discharges for the most recent 5-year period, based on
886 information available from the hospital inpatient discharge
887 database in the Florida Center for Health Information and Policy
888 Analysis at the Agency for Health Care Administration; or
889 5.6. A hospital designated as a critical access hospital,
890 as defined in s. 408.07(15).
891
892 Population densities used in this paragraph must be based upon
893 the most recently completed United States census. A hospital
894 that received funds under s. 409.9116 for a quarter beginning no
895 later than July 1, 2002, is deemed to have been and shall
896 continue to be a rural hospital from that date through June 30,
897 2015, if the hospital continues to have 100 or fewer licensed
898 beds and an emergency room, or meets the criteria of
899 subparagraph 4. An acute care hospital that has not previously
900 been designated as a rural hospital and that meets the criteria
901 of this paragraph shall be granted such designation upon
902 application, including supporting documentation to the Agency
903 for Health Care Administration.
904 Section 23. Subsection (8) of section 400.021, Florida
905 Statutes, is amended to read:
906 400.021 Definitions.—When used in this part, unless the
907 context otherwise requires, the term:
908 (8) “Geriatric outpatient clinic” means a site for
909 providing outpatient health care to persons 60 years of age or
910 older, which is staffed by a registered nurse or a physician
911 assistant, or a licensed practical nurse under the direct
912 supervision of a registered nurse, advanced registered nurse
913 practitioner, or physician.
914 Section 24. Paragraph (g) of subsection (2) of section
915 400.0239, Florida Statutes, is amended to read:
916 400.0239 Quality of Long-Term Care Facility Improvement
917 Trust Fund.—
918 (2) Expenditures from the trust fund shall be allowable for
919 direct support of the following:
920 (g) Other initiatives authorized by the Centers for
921 Medicare and Medicaid Services for the use of federal civil
922 monetary penalties, including projects recommended through the
923 Medicaid “Up-or-Out” Quality of Care Contract Management Program
924 pursuant to s. 400.148.
925 Section 25. Subsection (15) of section 400.0255, Florida
926 Statutes, is amended to read
927 400.0255 Resident transfer or discharge; requirements and
928 procedures; hearings.—
929 (15)(a) The department’s Office of Appeals Hearings shall
930 conduct hearings under this section. The office shall notify the
931 facility of a resident’s request for a hearing.
932 (b) The department shall, by rule, establish procedures to
933 be used for fair hearings requested by residents. These
934 procedures shall be equivalent to the procedures used for fair
935 hearings for other Medicaid cases appearing in s. 409.285 and
936 applicable rules, chapter 10-2, part VI, Florida Administrative
937 Code. The burden of proof must be clear and convincing evidence.
938 A hearing decision must be rendered within 90 days after receipt
939 of the request for hearing.
940 (c) If the hearing decision is favorable to the resident
941 who has been transferred or discharged, the resident must be
942 readmitted to the facility’s first available bed.
943 (d) The decision of the hearing officer shall be final. Any
944 aggrieved party may appeal the decision to the district court of
945 appeal in the appellate district where the facility is located.
946 Review procedures shall be conducted in accordance with the
947 Florida Rules of Appellate Procedure.
948 Section 26. Subsection (2) of section 400.063, Florida
949 Statutes, is amended to read:
950 400.063 Resident protection.—
951 (2) The agency is authorized to establish for each
952 facility, subject to intervention by the agency, a separate bank
953 account for the deposit to the credit of the agency of any
954 moneys received from the Health Care Trust Fund or any other
955 moneys received for the maintenance and care of residents in the
956 facility, and the agency is authorized to disburse moneys from
957 such account to pay obligations incurred for the purposes of
958 this section. The agency is authorized to requisition moneys
959 from the Health Care Trust Fund in advance of an actual need for
960 cash on the basis of an estimate by the agency of moneys to be
961 spent under the authority of this section. Any bank account
962 established under this section need not be approved in advance
963 of its creation as required by s. 17.58, but shall be secured by
964 depository insurance equal to or greater than the balance of
965 such account or by the pledge of collateral security in
966 conformance with criteria established in s. 18.11. The agency
967 shall notify the Chief Financial Officer of any such account so
968 established and shall make a quarterly accounting to the Chief
969 Financial Officer for all moneys deposited in such account.
970 Section 27. Subsections (1) and (5) of section 400.071,
971 Florida Statutes, are amended to read:
972 400.071 Application for license.—
973 (1) In addition to the requirements of part II of chapter
974 408, the application for a license shall be under oath and must
975 contain the following:
976 (a) The location of the facility for which a license is
977 sought and an indication, as in the original application, that
978 such location conforms to the local zoning ordinances.
979 (b) A signed affidavit disclosing any financial or
980 ownership interest that a controlling interest as defined in
981 part II of chapter 408 has held in the last 5 years in any
982 entity licensed by this state or any other state to provide
983 health or residential care which has closed voluntarily or
984 involuntarily; has filed for bankruptcy; has had a receiver
985 appointed; has had a license denied, suspended, or revoked; or
986 has had an injunction issued against it which was initiated by a
987 regulatory agency. The affidavit must disclose the reason any
988 such entity was closed, whether voluntarily or involuntarily.
989 (c) The total number of beds and the total number of
990 Medicare and Medicaid certified beds.
991 (b)(d) Information relating to the applicant and employees
992 which the agency requires by rule. The applicant must
993 demonstrate that sufficient numbers of qualified staff, by
994 training or experience, will be employed to properly care for
995 the type and number of residents who will reside in the
996 facility.
997 (c)(e) Copies of any civil verdict or judgment involving
998 the applicant rendered within the 10 years preceding the
999 application, relating to medical negligence, violation of
1000 residents’ rights, or wrongful death. As a condition of
1001 licensure, the licensee agrees to provide to the agency copies
1002 of any new verdict or judgment involving the applicant, relating
1003 to such matters, within 30 days after filing with the clerk of
1004 the court. The information required in this paragraph shall be
1005 maintained in the facility’s licensure file and in an agency
1006 database which is available as a public record.
1007 (5) As a condition of licensure, each facility must
1008 establish and submit with its application a plan for quality
1009 assurance and for conducting risk management.
1010 Section 28. Section 400.0712, Florida Statutes, is amended
1011 to read:
1012 400.0712 Application for inactive license.—
1013 (1) As specified in this section, the agency may issue an
1014 inactive license to a nursing home facility for all or a portion
1015 of its beds. Any request by a licensee that a nursing home or
1016 portion of a nursing home become inactive must be submitted to
1017 the agency in the approved format. The facility may not initiate
1018 any suspension of services, notify residents, or initiate
1019 inactivity before receiving approval from the agency; and a
1020 licensee that violates this provision may not be issued an
1021 inactive license.
1022 (1)(2) In addition to the powers granted under part II of
1023 chapter 408, the agency may issue an inactive license to a
1024 nursing home that chooses to use an unoccupied contiguous
1025 portion of the facility for an alternative use to meet the needs
1026 of elderly persons through the use of less restrictive, less
1027 institutional services.
1028 (a) An inactive license issued under this subsection may be
1029 granted for a period not to exceed the current licensure
1030 expiration date but may be renewed by the agency at the time of
1031 licensure renewal.
1032 (b) A request to extend the inactive license must be
1033 submitted to the agency in the approved format and approved by
1034 the agency in writing.
1035 (c) Nursing homes that receive an inactive license to
1036 provide alternative services shall not receive preference for
1037 participation in the Assisted Living for the Elderly Medicaid
1038 waiver.
1039 (2)(3) The agency shall adopt rules pursuant to ss.
1040 120.536(1) and 120.54 necessary to implement this section.
1041 Section 29. Section 400.111, Florida Statutes, is amended
1042 to read:
1043 400.111 Disclosure of controlling interest.—In addition to
1044 the requirements of part II of chapter 408, when requested by
1045 the agency, the licensee shall submit a signed affidavit
1046 disclosing any financial or ownership interest that a
1047 controlling interest has held within the last 5 years in any
1048 entity licensed by the state or any other state to provide
1049 health or residential care which entity has closed voluntarily
1050 or involuntarily; has filed for bankruptcy; has had a receiver
1051 appointed; has had a license denied, suspended, or revoked; or
1052 has had an injunction issued against it which was initiated by a
1053 regulatory agency. The affidavit must disclose the reason such
1054 entity was closed, whether voluntarily or involuntarily.
1055 Section 30. Subsection (2) of section 400.1183, Florida
1056 Statutes, is amended to read:
1057 400.1183 Resident grievance procedures.—
1058 (2) Each facility shall maintain records of all grievances
1059 for agency inspection and shall report to the agency at the time
1060 of relicensure the total number of grievances handled during the
1061 prior licensure period, a categorization of the cases underlying
1062 the grievances, and the final disposition of the grievances.
1063 Section 31. Paragraphs (o) through (w) of subsection (1) of
1064 section 400.141, Florida Statutes, are redesignated as
1065 paragraphs (n) through (u), respectively, and present paragraphs
1066 (f), (g), (j), (n), (o), and (r) of that subsection are amended,
1067 to read:
1068 400.141 Administration and management of nursing home
1069 facilities.—
1070 (1) Every licensed facility shall comply with all
1071 applicable standards and rules of the agency and shall:
1072 (f) Be allowed and encouraged by the agency to provide
1073 other needed services under certain conditions. If the facility
1074 has a standard licensure status, and has had no class I or class
1075 II deficiencies during the past 2 years or has been awarded a
1076 Gold Seal under the program established in s. 400.235, it may be
1077 encouraged by the agency to provide services, including, but not
1078 limited to, respite and adult day services, which enable
1079 individuals to move in and out of the facility. A facility is
1080 not subject to any additional licensure requirements for
1081 providing these services.
1082 1. Respite care may be offered to persons in need of short
1083 term or temporary nursing home services. For each person
1084 admitted under the respite care program, the facility licensee
1085 must:
1086 a. Have a written abbreviated plan of care that, at a
1087 minimum, includes nutritional requirements, medication orders,
1088 physician orders, nursing assessments, and dietary preferences.
1089 The nursing or physician assessments may take the place of all
1090 other assessments required for full-time residents.
1091 b. Have a contract that, at a minimum, specifies the
1092 services to be provided to the respite resident, including
1093 charges for services, activities, equipment, emergency medical
1094 services, and the administration of medications. If multiple
1095 respite admissions for a single person are anticipated, the
1096 original contract is valid for 1 year after the date of
1097 execution.
1098 c. Ensure that each resident is released to his or her
1099 caregiver or an individual designated in writing by the
1100 caregiver.
1101 2. A person admitted under the respite care program is:
1102 a. Exempt from requirements in rule related to discharge
1103 planning.
1104 b. Covered by the resident’s rights set forth in s.
1105 400.022(1)(a)-(o) and (r)-(t). Funds or property of the resident
1106 shall not be considered trust funds subject to the requirements
1107 of s. 400.022(1)(h) until the resident has been in the facility
1108 for more than 14 consecutive days.
1109 c. Allowed to use his or her personal medications for the
1110 respite stay if permitted by facility policy. The facility must
1111 obtain a physician’s orders for the medications. The caregiver
1112 may provide information regarding the medications as part of the
1113 nursing assessment, which must agree with the physician’s
1114 orders. Medications shall be released with the resident upon
1115 discharge in accordance with current orders.
1116 3. A person receiving respite care is entitled to a total
1117 of 60 days in the facility within a contract year or a calendar
1118 year if the contract is for less than 12 months. However, each
1119 single stay may not exceed 14 days. If a stay exceeds 14
1120 consecutive days, the facility must comply with all assessment
1121 and care planning requirements applicable to nursing home
1122 residents.
1123 4. A person receiving respite care must reside in a
1124 licensed nursing home bed.
1125 5. A prospective respite resident must provide medical
1126 information from a physician, a physician assistant, or a nurse
1127 practitioner and other information from the primary caregiver as
1128 may be required by the facility prior to or at the time of
1129 admission to receive respite care. The medical information must
1130 include a physician’s order for respite care and proof of a
1131 physical examination by a licensed physician, physician
1132 assistant, or nurse practitioner. The physician’s order and
1133 physical examination may be used to provide intermittent respite
1134 care for up to 12 months after the date the order is written.
1135 6. The facility must assume the duties of the primary
1136 caregiver. To ensure continuity of care and services, the
1137 resident is entitled to retain his or her personal physician and
1138 must have access to medically necessary services such as
1139 physical therapy, occupational therapy, or speech therapy, as
1140 needed. The facility must arrange for transportation to these
1141 services if necessary. Respite care must be provided in
1142 accordance with this part and rules adopted by the agency.
1143 However, the agency shall, by rule, adopt modified requirements
1144 for resident assessment, resident care plans, resident
1145 contracts, physician orders, and other provisions, as
1146 appropriate, for short-term or temporary nursing home services.
1147 7. The agency shall allow for shared programming and staff
1148 in a facility which meets minimum standards and offers services
1149 pursuant to this paragraph, but, if the facility is cited for
1150 deficiencies in patient care, may require additional staff and
1151 programs appropriate to the needs of service recipients. A
1152 person who receives respite care may not be counted as a
1153 resident of the facility for purposes of the facility’s licensed
1154 capacity unless that person receives 24-hour respite care. A
1155 person receiving either respite care for 24 hours or longer or
1156 adult day services must be included when calculating minimum
1157 staffing for the facility. Any costs and revenues generated by a
1158 nursing home facility from nonresidential programs or services
1159 shall be excluded from the calculations of Medicaid per diems
1160 for nursing home institutional care reimbursement.
1161 (g) If the facility has a standard license or is a Gold
1162 Seal facility, exceeds the minimum required hours of licensed
1163 nursing and certified nursing assistant direct care per resident
1164 per day, and is part of a continuing care facility licensed
1165 under chapter 651 or a retirement community that offers other
1166 services pursuant to part III of this chapter or part I or part
1167 III of chapter 429 on a single campus, be allowed to share
1168 programming and staff. At the time of inspection and in the
1169 semiannual report required pursuant to paragraph (n) (o), a
1170 continuing care facility or retirement community that uses this
1171 option must demonstrate through staffing records that minimum
1172 staffing requirements for the facility were met. Licensed nurses
1173 and certified nursing assistants who work in the nursing home
1174 facility may be used to provide services elsewhere on campus if
1175 the facility exceeds the minimum number of direct care hours
1176 required per resident per day and the total number of residents
1177 receiving direct care services from a licensed nurse or a
1178 certified nursing assistant does not cause the facility to
1179 violate the staffing ratios required under s. 400.23(3)(a).
1180 Compliance with the minimum staffing ratios shall be based on
1181 total number of residents receiving direct care services,
1182 regardless of where they reside on campus. If the facility
1183 receives a conditional license, it may not share staff until the
1184 conditional license status ends. This paragraph does not
1185 restrict the agency’s authority under federal or state law to
1186 require additional staff if a facility is cited for deficiencies
1187 in care which are caused by an insufficient number of certified
1188 nursing assistants or licensed nurses. The agency may adopt
1189 rules for the documentation necessary to determine compliance
1190 with this provision.
1191 (j) Keep full records of resident admissions and
1192 discharges; medical and general health status, including medical
1193 records, personal and social history, and identity and address
1194 of next of kin or other persons who may have responsibility for
1195 the affairs of the residents; and individual resident care plans
1196 including, but not limited to, prescribed services, service
1197 frequency and duration, and service goals. The records shall be
1198 open to inspection by the agency. The facility must maintain
1199 clinical records on each resident in accordance with accepted
1200 professional standards and practices that are complete,
1201 accurately documented, readily accessible, and systematically
1202 organized.
1203 (n) Submit to the agency the information specified in s.
1204 400.071(1)(b) for a management company within 30 days after the
1205 effective date of the management agreement.
1206 (n)(o)1. Submit semiannually to the agency, or more
1207 frequently if requested by the agency, information regarding
1208 facility staff-to-resident ratios, staff turnover, and staff
1209 stability, including information regarding certified nursing
1210 assistants, licensed nurses, the director of nursing, and the
1211 facility administrator. For purposes of this reporting:
1212 a. Staff-to-resident ratios must be reported in the
1213 categories specified in s. 400.23(3)(a) and applicable rules.
1214 The ratio must be reported as an average for the most recent
1215 calendar quarter.
1216 b. Staff turnover must be reported for the most recent 12
1217 month period ending on the last workday of the most recent
1218 calendar quarter prior to the date the information is submitted.
1219 The turnover rate must be computed quarterly, with the annual
1220 rate being the cumulative sum of the quarterly rates. The
1221 turnover rate is the total number of terminations or separations
1222 experienced during the quarter, excluding any employee
1223 terminated during a probationary period of 3 months or less,
1224 divided by the total number of staff employed at the end of the
1225 period for which the rate is computed, and expressed as a
1226 percentage.
1227 c. The formula for determining staff stability is the total
1228 number of employees that have been employed for more than 12
1229 months, divided by the total number of employees employed at the
1230 end of the most recent calendar quarter, and expressed as a
1231 percentage.
1232 d. A nursing facility that has failed to comply with state
1233 minimum-staffing requirements for 2 consecutive days is
1234 prohibited from accepting new admissions until the facility has
1235 achieved the minimum-staffing requirements for a period of 6
1236 consecutive days. For the purposes of this sub-subparagraph, any
1237 person who was a resident of the facility and was absent from
1238 the facility for the purpose of receiving medical care at a
1239 separate location or was on a leave of absence is not considered
1240 a new admission. Failure to impose such an admissions moratorium
1241 is subject to a $1,000 fine constitutes a class II deficiency.
1242 e. A nursing facility which does not have a conditional
1243 license may be cited for failure to comply with the standards in
1244 s. 400.23(3)(a)1.a. only if it has failed to meet those
1245 standards on 2 consecutive days or if it has failed to meet at
1246 least 97 percent of those standards on any one day.
1247 f. A facility which has a conditional license must be in
1248 compliance with the standards in s. 400.23(3)(a) at all times.
1249 2. This paragraph does not limit the agency’s ability to
1250 impose a deficiency or take other actions if a facility does not
1251 have enough staff to meet the residents’ needs.
1252 (r) Report to the agency any filing for bankruptcy
1253 protection by the facility or its parent corporation,
1254 divestiture or spin-off of its assets, or corporate
1255 reorganization within 30 days after the completion of such
1256 activity.
1257 Section 32. Subsection (3) of section 400.142, Florida
1258 Statutes, is amended to read:
1259 400.142 Emergency medication kits; orders not to
1260 resuscitate.—
1261 (3) Facility staff may withhold or withdraw cardiopulmonary
1262 resuscitation if presented with an order not to resuscitate
1263 executed pursuant to s. 401.45. The agency shall adopt rules
1264 providing for the implementation of such orders. Facility staff
1265 and facilities shall not be subject to criminal prosecution or
1266 civil liability, nor be considered to have engaged in negligent
1267 or unprofessional conduct, for withholding or withdrawing
1268 cardiopulmonary resuscitation pursuant to such an order and
1269 rules adopted by the agency. The absence of an order not to
1270 resuscitate executed pursuant to s. 401.45 does not preclude a
1271 physician from withholding or withdrawing cardiopulmonary
1272 resuscitation as otherwise permitted by law.
1273 Section 33. Subsections (11) through (15) of section
1274 400.147, Florida Statutes, are renumbered as subsections (10)
1275 through (14), respectively, and present subsection (10) is
1276 amended to read:
1277 400.147 Internal risk management and quality assurance
1278 program.—
1279 (10) By the 10th of each month, each facility subject to
1280 this section shall report any notice received pursuant to s.
1281 400.0233(2) and each initial complaint that was filed with the
1282 clerk of the court and served on the facility during the
1283 previous month by a resident or a resident’s family member,
1284 guardian, conservator, or personal legal representative. The
1285 report must include the name of the resident, the resident’s
1286 date of birth and social security number, the Medicaid
1287 identification number for Medicaid-eligible persons, the date or
1288 dates of the incident leading to the claim or dates of
1289 residency, if applicable, and the type of injury or violation of
1290 rights alleged to have occurred. Each facility shall also submit
1291 a copy of the notices received pursuant to s. 400.0233(2) and
1292 complaints filed with the clerk of the court. This report is
1293 confidential as provided by law and is not discoverable or
1294 admissible in any civil or administrative action, except in such
1295 actions brought by the agency to enforce the provisions of this
1296 part.
1297 Section 34. Section 400.148, Florida Statutes, is repealed.
1298 Section 35. Paragraph (f) of subsection (5) of section
1299 400.162, Florida Statutes, is amended to read:
1300 400.162 Property and personal affairs of residents.—
1301 (5)
1302 (f) At least every 3 months, the licensee shall furnish the
1303 resident and the guardian, trustee, or conservator, if any, for
1304 the resident a complete and verified statement of all funds and
1305 other property to which this subsection applies, detailing the
1306 amounts and items received, together with their sources and
1307 disposition. For resident property, the licensee shall furnish
1308 such a statement annually and within 7 calendar days after a
1309 request for a statement. In any event, the licensee shall
1310 furnish such statements a statement annually and upon the
1311 discharge or transfer of a resident. Any governmental agency or
1312 private charitable agency contributing funds or other property
1313 on account of a resident also shall be entitled to receive such
1314 statements statement annually and upon discharge or transfer and
1315 such other report as it may require pursuant to law.
1316 Section 36. Paragraphs (d) and (e) of subsection (2) of
1317 section 400.179, Florida Statutes, are amended to read:
1318 400.179 Liability for Medicaid underpayments and
1319 overpayments.—
1320 (2) Because any transfer of a nursing facility may expose
1321 the fact that Medicaid may have underpaid or overpaid the
1322 transferor, and because in most instances, any such underpayment
1323 or overpayment can only be determined following a formal field
1324 audit, the liabilities for any such underpayments or
1325 overpayments shall be as follows:
1326 (d) Where the transfer involves a facility that has been
1327 leased by the transferor:
1328 1. The transferee shall, as a condition to being issued a
1329 license by the agency, acquire, maintain, and provide proof to
1330 the agency of a bond with a term of 30 months, renewable
1331 annually, in an amount not less than the total of 3 months’
1332 Medicaid payments to the facility computed on the basis of the
1333 preceding 12-month average Medicaid payments to the facility.
1334 2. A leasehold licensee may meet the requirements of
1335 subparagraph 1. by payment of a nonrefundable fee, paid at
1336 initial licensure, paid at the time of any subsequent change of
1337 ownership, and paid annually thereafter, in the amount of 1
1338 percent of the total of 3 months’ Medicaid payments to the
1339 facility computed on the basis of the preceding 12-month average
1340 Medicaid payments to the facility. If a preceding 12-month
1341 average is not available, projected Medicaid payments may be
1342 used. The fee shall be deposited into the Grants and Donations
1343 Trust Fund and shall be accounted for separately as a Medicaid
1344 nursing home overpayment account. These fees shall be used at
1345 the sole discretion of the agency to repay nursing home Medicaid
1346 overpayments. Payment of this fee shall not release the licensee
1347 from any liability for any Medicaid overpayments, nor shall
1348 payment bar the agency from seeking to recoup overpayments from
1349 the licensee and any other liable party. As a condition of
1350 exercising this lease bond alternative, licensees paying this
1351 fee must maintain an existing lease bond through the end of the
1352 30-month term period of that bond. The agency is herein granted
1353 specific authority to promulgate all rules pertaining to the
1354 administration and management of this account, including
1355 withdrawals from the account, subject to federal review and
1356 approval. This provision shall take effect upon becoming law and
1357 shall apply to any leasehold license application. The financial
1358 viability of the Medicaid nursing home overpayment account shall
1359 be determined by the agency through annual review of the account
1360 balance and the amount of total outstanding, unpaid Medicaid
1361 overpayments owing from leasehold licensees to the agency as
1362 determined by final agency audits. By March 31 of each year, the
1363 agency shall assess the cumulative fees collected under this
1364 subparagraph, minus any amounts used to repay nursing home
1365 Medicaid overpayments and amounts transferred to contribute to
1366 the General Revenue Fund pursuant to s. 215.20. If the net
1367 cumulative collections, minus amounts utilized to repay nursing
1368 home Medicaid overpayments, exceed $25 million, the provisions
1369 of this paragraph shall not apply for the subsequent fiscal
1370 year.
1371 3. The leasehold licensee may meet the bond requirement
1372 through other arrangements acceptable to the agency. The agency
1373 is herein granted specific authority to promulgate rules
1374 pertaining to lease bond arrangements.
1375 4. All existing nursing facility licensees, operating the
1376 facility as a leasehold, shall acquire, maintain, and provide
1377 proof to the agency of the 30-month bond required in
1378 subparagraph 1., above, on and after July 1, 1993, for each
1379 license renewal.
1380 5. It shall be the responsibility of all nursing facility
1381 operators, operating the facility as a leasehold, to renew the
1382 30-month bond and to provide proof of such renewal to the agency
1383 annually.
1384 6. Any failure of the nursing facility operator to acquire,
1385 maintain, renew annually, or provide proof to the agency shall
1386 be grounds for the agency to deny, revoke, and suspend the
1387 facility license to operate such facility and to take any
1388 further action, including, but not limited to, enjoining the
1389 facility, asserting a moratorium pursuant to part II of chapter
1390 408, or applying for a receiver, deemed necessary to ensure
1391 compliance with this section and to safeguard and protect the
1392 health, safety, and welfare of the facility’s residents. A lease
1393 agreement required as a condition of bond financing or
1394 refinancing under s. 154.213 by a health facilities authority or
1395 required under s. 159.30 by a county or municipality is not a
1396 leasehold for purposes of this paragraph and is not subject to
1397 the bond requirement of this paragraph.
1398 (e) For the 2009-2010 fiscal year only, the provisions of
1399 paragraph (d) shall not apply. This paragraph expires July 1,
1400 2010.
1401 Section 37. Subsection (3) of section 400.19, Florida
1402 Statutes, is amended to read:
1403 400.19 Right of entry and inspection.—
1404 (3) The agency shall every 15 months conduct at least one
1405 unannounced inspection to determine compliance by the licensee
1406 with statutes, and with rules promulgated under the provisions
1407 of those statutes, governing minimum standards of construction,
1408 quality and adequacy of care, and rights of residents. The
1409 survey shall be conducted every 6 months for the next 2-year
1410 period if the facility has been cited for a class I deficiency,
1411 has been cited for two or more class II deficiencies arising
1412 from separate surveys or investigations within a 60-day period,
1413 or has had three or more substantiated complaints within a 6
1414 month period, each resulting in at least one class I or class II
1415 deficiency. In addition to any other fees or fines in this part,
1416 the agency shall assess a fine for each facility that is subject
1417 to the 6-month survey cycle. The fine for the 2-year period
1418 shall be $6,000, one-half to be paid at the completion of each
1419 survey. The agency may adjust this fine by the change in the
1420 Consumer Price Index, based on the 12 months immediately
1421 preceding the increase, to cover the cost of the additional
1422 surveys. The agency shall verify through subsequent inspection
1423 that any deficiency identified during inspection is corrected.
1424 However, the agency may verify the correction of a class III or
1425 class IV deficiency unrelated to resident rights or resident
1426 care without reinspecting the facility if adequate written
1427 documentation has been received from the facility, which
1428 provides assurance that the deficiency has been corrected. The
1429 giving or causing to be given of advance notice of such
1430 unannounced inspections by an employee of the agency to any
1431 unauthorized person shall constitute cause for suspension of not
1432 fewer than 5 working days according to the provisions of chapter
1433 110.
1434 Section 38. Section 400.195, Florida Statutes, is repealed.
1435 Section 39. Subsection (5) of section 400.23, Florida
1436 Statutes, is amended to read:
1437 400.23 Rules; evaluation and deficiencies; licensure
1438 status.—
1439 (5)(a) The agency, in collaboration with the Division of
1440 Children’s Medical Services Network of the Department of Health,
1441 must, no later than December 31, 1993, adopt rules for minimum
1442 standards of care for persons under 21 years of age who reside
1443 in nursing home facilities. The rules must include a methodology
1444 for reviewing a nursing home facility under ss. 408.031-408.045
1445 which serves only persons under 21 years of age. A facility may
1446 be exempt from these standards for specific persons between 18
1447 and 21 years of age, if the person’s physician agrees that
1448 minimum standards of care based on age are not necessary.
1449 (b) The agency, in collaboration with the Division of
1450 Children’s Medical Services Network, shall adopt rules for
1451 minimum staffing requirements for nursing home facilities that
1452 serve persons under 21 years of age, which shall apply in lieu
1453 of the standards contained in subsection (3).
1454 1. For persons under 21 years of age who require skilled
1455 care, the requirements shall include a minimum combined average
1456 of licensed nurses, respiratory therapists, respiratory care
1457 practitioners, and certified nursing assistants of 3.9 hours of
1458 direct care per resident per day for each nursing home facility.
1459 2. For persons under 21 years of age who are fragile, the
1460 requirements shall include a minimum combined average of
1461 licensed nurses, respiratory therapists, respiratory care
1462 practitioners, and certified nursing assistants of 5 hours of
1463 direct care per resident per day for each nursing home facility.
1464 Section 40. Subsection (1) of section 400.275, Florida
1465 Statutes, is amended to read:
1466 400.275 Agency duties.—
1467 (1) The agency shall ensure that each newly hired nursing
1468 home surveyor, as a part of basic training, is assigned full
1469 time to a licensed nursing home for at least 2 days within a 7
1470 day period to observe facility operations outside of the survey
1471 process before the surveyor begins survey responsibilities. Such
1472 observations may not be the sole basis of a deficiency citation
1473 against the facility. The agency may not assign an individual to
1474 be a member of a survey team for purposes of a survey,
1475 evaluation, or consultation visit at a nursing home facility in
1476 which the surveyor was an employee within the preceding 2 5
1477 years.
1478 Section 41. Subsection (2) of section 400.484, Florida
1479 Statutes, is amended to read:
1480 400.484 Right of inspection; violations deficiencies;
1481 fines.—
1482 (2) The agency shall impose fines for various classes of
1483 violations deficiencies in accordance with the following
1484 schedule:
1485 (a) Class I violations are defined in s. 408.813. A class I
1486 deficiency is any act, omission, or practice that results in a
1487 patient’s death, disablement, or permanent injury, or places a
1488 patient at imminent risk of death, disablement, or permanent
1489 injury. Upon finding a class I violation deficiency, the agency
1490 shall impose an administrative fine in the amount of $15,000 for
1491 each occurrence and each day that the violation deficiency
1492 exists.
1493 (b) Class II violations are defined in s. 408.813. A class
1494 II deficiency is any act, omission, or practice that has a
1495 direct adverse effect on the health, safety, or security of a
1496 patient. Upon finding a class II violation deficiency, the
1497 agency shall impose an administrative fine in the amount of
1498 $5,000 for each occurrence and each day that the violation
1499 deficiency exists.
1500 (c) Class III violations are defined in s. 408.813. A class
1501 III deficiency is any act, omission, or practice that has an
1502 indirect, adverse effect on the health, safety, or security of a
1503 patient. Upon finding an uncorrected or repeated class III
1504 violation deficiency, the agency shall impose an administrative
1505 fine not to exceed $1,000 for each occurrence and each day that
1506 the uncorrected or repeated violation deficiency exists.
1507 (d) Class IV violations are defined in s. 408.813. A class
1508 IV deficiency is any act, omission, or practice related to
1509 required reports, forms, or documents which does not have the
1510 potential of negatively affecting patients. These violations are
1511 of a type that the agency determines do not threaten the health,
1512 safety, or security of patients. Upon finding an uncorrected or
1513 repeated class IV violation deficiency, the agency shall impose
1514 an administrative fine not to exceed $500 for each occurrence
1515 and each day that the uncorrected or repeated violation
1516 deficiency exists.
1517 Section 42. Paragraph (i) of subsection (1) and subsection
1518 (4) of section 400.606, Florida Statutes, are amended to read:
1519 400.606 License; application; renewal; conditional license
1520 or permit; certificate of need.—
1521 (1) In addition to the requirements of part II of chapter
1522 408, the initial application and change of ownership application
1523 must be accompanied by a plan for the delivery of home,
1524 residential, and homelike inpatient hospice services to
1525 terminally ill persons and their families. Such plan must
1526 contain, but need not be limited to:
1527 (i) The projected annual operating cost of the hospice.
1528
1529 If the applicant is an existing licensed health care provider,
1530 the application must be accompanied by a copy of the most recent
1531 profit-loss statement and, if applicable, the most recent
1532 licensure inspection report.
1533 (4) A freestanding hospice facility that is primarily
1534 engaged in providing inpatient and related services and that is
1535 not otherwise licensed as a health care facility shall be
1536 required to obtain a certificate of need. However, a
1537 freestanding hospice facility with six or fewer beds shall not
1538 be required to comply with institutional standards such as, but
1539 not limited to, standards requiring sprinkler systems, emergency
1540 electrical systems, or special lavatory devices.
1541 Section 43. Subsection (2) of section 400.607, Florida
1542 Statutes, is amended to read:
1543 400.607 Denial, suspension, revocation of license;
1544 emergency actions; imposition of administrative fine; grounds.—
1545 (2) A violation of this part, part II of chapter 408, or
1546 applicable rules Any of the following actions by a licensed
1547 hospice or any of its employees shall be grounds for
1548 administrative action by the agency against a hospice.:
1549 (a) A violation of the provisions of this part, part II of
1550 chapter 408, or applicable rules.
1551 (b) An intentional or negligent act materially affecting
1552 the health or safety of a patient.
1553 Section 44. Section 400.915, Florida Statutes, is amended
1554 to read:
1555 400.915 Construction and renovation; requirements.—The
1556 requirements for the construction or renovation of a PPEC center
1557 shall comply with:
1558 (1) The provisions of chapter 553, which pertain to
1559 building construction standards, including plumbing, electrical
1560 code, glass, manufactured buildings, accessibility for the
1561 physically disabled;
1562 (2) The provisions of s. 633.022 and applicable rules
1563 pertaining to physical minimum standards for nonresidential
1564 child care physical facilities in rule 10M-12.003, Florida
1565 Administrative Code, Child Care Standards; and
1566 (3) The standards or rules adopted pursuant to this part
1567 and part II of chapter 408.
1568 Section 45. Subsection (1) of section 400.925, Florida
1569 Statutes, is amended to read:
1570 400.925 Definitions.—As used in this part, the term:
1571 (1) “Accrediting organizations” means The Joint Commission
1572 on Accreditation of Healthcare Organizations or other national
1573 accreditation agencies whose standards for accreditation are
1574 comparable to those required by this part for licensure.
1575 Section 46. Subsections (3) through (6) of section 400.931,
1576 Florida Statutes, are renumbered as subsections (2) through (5),
1577 respectively, and present subsection (2) of that section is
1578 amended to read:
1579 400.931 Application for license; fee; provisional license;
1580 temporary permit.—
1581 (2) As an alternative to submitting proof of financial
1582 ability to operate as required in s. 408.810(8), the applicant
1583 may submit a $50,000 surety bond to the agency.
1584 Section 47. Subsection (2) of section 400.932, Florida
1585 Statutes, is amended to read:
1586 400.932 Administrative penalties.—
1587 (2) A violation of this part, part II of chapter 408, or
1588 applicable rules Any of the following actions by an employee of
1589 a home medical equipment provider shall be are grounds for
1590 administrative action or penalties by the agency.:
1591 (a) Violation of this part, part II of chapter 408, or
1592 applicable rules.
1593 (b) An intentional, reckless, or negligent act that
1594 materially affects the health or safety of a patient.
1595 Section 48. Subsection (3) of section 400.967, Florida
1596 Statutes, is amended to read:
1597 400.967 Rules and classification of violations
1598 deficiencies.—
1599 (3) The agency shall adopt rules to provide that, when the
1600 criteria established under this part and part II of chapter 408
1601 are not met, such violations deficiencies shall be classified
1602 according to the nature of the violation deficiency. The agency
1603 shall indicate the classification on the face of the notice of
1604 deficiencies as follows:
1605 (a) Class I violations deficiencies are defined in s.
1606 408.813 those which the agency determines present an imminent
1607 danger to the residents or guests of the facility or a
1608 substantial probability that death or serious physical harm
1609 would result therefrom. The condition or practice constituting a
1610 class I violation must be abated or eliminated immediately,
1611 unless a fixed period of time, as determined by the agency, is
1612 required for correction. A class I violation deficiency is
1613 subject to a civil penalty in an amount not less than $5,000 and
1614 not exceeding $10,000 for each violation deficiency. A fine may
1615 be levied notwithstanding the correction of the violation
1616 deficiency.
1617 (b) Class II violations deficiencies are defined in s.
1618 408.813 those which the agency determines have a direct or
1619 immediate relationship to the health, safety, or security of the
1620 facility residents, other than class I deficiencies. A class II
1621 violation deficiency is subject to a civil penalty in an amount
1622 not less than $1,000 and not exceeding $5,000 for each violation
1623 deficiency. A citation for a class II violation deficiency shall
1624 specify the time within which the violation deficiency must be
1625 corrected. If a class II violation deficiency is corrected
1626 within the time specified, no civil penalty shall be imposed,
1627 unless it is a repeated offense.
1628 (c) Class III violations deficiencies are defined in s.
1629 408.813 those which the agency determines to have an indirect or
1630 potential relationship to the health, safety, or security of the
1631 facility residents, other than class I or class II deficiencies.
1632 A class III violation deficiency is subject to a civil penalty
1633 of not less than $500 and not exceeding $1,000 for each
1634 deficiency. A citation for a class III violation deficiency
1635 shall specify the time within which the violation deficiency
1636 must be corrected. If a class III violation deficiency is
1637 corrected within the time specified, no civil penalty shall be
1638 imposed, unless it is a repeated offense.
1639 (d) Class IV violations are defined in s. 408.813. Upon
1640 finding an uncorrected or repeated class IV violation, the
1641 agency shall impose an administrative fine not to exceed $500
1642 for each occurrence and each day that the uncorrected or
1643 repeated violation exists.
1644 Section 49. Subsections (4) and (7) of section 400.9905,
1645 Florida Statutes, are amended to read:
1646 400.9905 Definitions.—
1647 (4) “Clinic” means an entity at which health care services
1648 are provided to individuals and which tenders charges for
1649 reimbursement for such services, including a mobile clinic and a
1650 portable health service or equipment provider. For purposes of
1651 this part, the term does not include and the licensure
1652 requirements of this part do not apply to:
1653 (a) Entities licensed or registered by the state under
1654 chapter 395; or entities licensed or registered by the state and
1655 providing only health care services within the scope of services
1656 authorized under their respective licenses granted under ss.
1657 383.30-383.335, chapter 390, chapter 394, chapter 397, this
1658 chapter except part X, chapter 429, chapter 463, chapter 465,
1659 chapter 466, chapter 478, part I of chapter 483, chapter 484, or
1660 chapter 651; end-stage renal disease providers authorized under
1661 42 C.F.R. part 405, subpart U; or providers certified under 42
1662 C.F.R. part 485, subpart B or subpart H; or any entity that
1663 provides neonatal or pediatric hospital-based health care
1664 services or other health care services by licensed practitioners
1665 solely within a hospital licensed under chapter 395.
1666 (b) Entities that own, directly or indirectly, entities
1667 licensed or registered by the state pursuant to chapter 395; or
1668 entities that own, directly or indirectly, entities licensed or
1669 registered by the state and providing only health care services
1670 within the scope of services authorized pursuant to their
1671 respective licenses granted under ss. 383.30-383.335, chapter
1672 390, chapter 394, chapter 397, this chapter except part X,
1673 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
1674 part I of chapter 483, chapter 484, chapter 651; end-stage renal
1675 disease providers authorized under 42 C.F.R. part 405, subpart
1676 U; or providers certified under 42 C.F.R. part 485, subpart B or
1677 subpart H; or any entity that provides neonatal or pediatric
1678 hospital-based health care services by licensed practitioners
1679 solely within a hospital licensed under chapter 395.
1680 (c) Entities that are owned, directly or indirectly, by an
1681 entity licensed or registered by the state pursuant to chapter
1682 395; or entities that are owned, directly or indirectly, by an
1683 entity licensed or registered by the state and providing only
1684 health care services within the scope of services authorized
1685 pursuant to their respective licenses granted under ss. 383.30
1686 383.335, chapter 390, chapter 394, chapter 397, this chapter
1687 except part X, chapter 429, chapter 463, chapter 465, chapter
1688 466, chapter 478, part I of chapter 483, chapter 484, or chapter
1689 651; end-stage renal disease providers authorized under 42
1690 C.F.R. part 405, subpart U; or providers certified under 42
1691 C.F.R. part 485, subpart B or subpart H; or any entity that
1692 provides neonatal or pediatric hospital-based health care
1693 services by licensed practitioners solely within a hospital
1694 under chapter 395.
1695 (d) Entities that are under common ownership, directly or
1696 indirectly, with an entity licensed or registered by the state
1697 pursuant to chapter 395; or entities that are under common
1698 ownership, directly or indirectly, with an entity licensed or
1699 registered by the state and providing only health care services
1700 within the scope of services authorized pursuant to their
1701 respective licenses granted under ss. 383.30-383.335, chapter
1702 390, chapter 394, chapter 397, this chapter except part X,
1703 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
1704 part I of chapter 483, chapter 484, or chapter 651; end-stage
1705 renal disease providers authorized under 42 C.F.R. part 405,
1706 subpart U; or providers certified under 42 C.F.R. part 485,
1707 subpart B or subpart H; or any entity that provides neonatal or
1708 pediatric hospital-based health care services by licensed
1709 practitioners solely within a hospital licensed under chapter
1710 395.
1711 (e) An entity that is exempt from federal taxation under 26
1712 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan
1713 under 26 U.S.C. s. 409 that has a board of trustees not less
1714 than two-thirds of which are Florida-licensed health care
1715 practitioners and provides only physical therapy services under
1716 physician orders, any community college or university clinic,
1717 and any entity owned or operated by the federal or state
1718 government, including agencies, subdivisions, or municipalities
1719 thereof.
1720 (f) A sole proprietorship, group practice, partnership, or
1721 corporation that provides health care services by physicians
1722 covered by s. 627.419, that is directly supervised by one or
1723 more of such physicians, and that is wholly owned by one or more
1724 of those physicians or by a physician and the spouse, parent,
1725 child, or sibling of that physician.
1726 (g) A sole proprietorship, group practice, partnership, or
1727 corporation that provides health care services by licensed
1728 health care practitioners under chapter 457, chapter 458,
1729 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
1730 chapter 466, chapter 467, chapter 480, chapter 484, chapter 486,
1731 chapter 490, chapter 491, or part I, part III, part X, part
1732 XIII, or part XIV of chapter 468, or s. 464.012, which are
1733 wholly owned by one or more licensed health care practitioners,
1734 or the licensed health care practitioners set forth in this
1735 paragraph and the spouse, parent, child, or sibling of a
1736 licensed health care practitioner, so long as one of the owners
1737 who is a licensed health care practitioner is supervising the
1738 business activities and is legally responsible for the entity’s
1739 compliance with all federal and state laws. However, a health
1740 care practitioner may not supervise services beyond the scope of
1741 the practitioner’s license, except that, for the purposes of
1742 this part, a clinic owned by a licensee in s. 456.053(3)(b) that
1743 provides only services authorized pursuant to s. 456.053(3)(b)
1744 may be supervised by a licensee specified in s. 456.053(3)(b).
1745 (h) Clinical facilities affiliated with an accredited
1746 medical school at which training is provided for medical
1747 students, residents, or fellows.
1748 (i) Entities that provide only oncology or radiation
1749 therapy services by physicians licensed under chapter 458 or
1750 chapter 459 or entities that provide oncology or radiation
1751 therapy services by physicians licensed under chapter 458 or
1752 chapter 459 which are owned by a corporation whose shares are
1753 publicly traded on a recognized stock exchange.
1754 (j) Clinical facilities affiliated with a college of
1755 chiropractic accredited by the Council on Chiropractic Education
1756 at which training is provided for chiropractic students.
1757 (k) Entities that provide licensed practitioners to staff
1758 emergency departments or to deliver anesthesia services in
1759 facilities licensed under chapter 395 and that derive at least
1760 90 percent of their gross annual revenues from the provision of
1761 such services. Entities claiming an exemption from licensure
1762 under this paragraph must provide documentation demonstrating
1763 compliance.
1764 (l) Orthotic, or prosthetic, pediatric cardiology, or
1765 perinatology clinical facilities that are a publicly traded
1766 corporation or that are wholly owned, directly or indirectly, by
1767 a publicly traded corporation. As used in this paragraph, a
1768 publicly traded corporation is a corporation that issues
1769 securities traded on an exchange registered with the United
1770 States Securities and Exchange Commission as a national
1771 securities exchange.
1772 (m) Entities that are owned by a corporation that has $250
1773 million or more in total annual sales of health care services
1774 provided by licensed health care practitioners if one or more of
1775 the owners of the entity is a health care practitioner who is
1776 licensed in this state, is responsible for supervising the
1777 business activities of the entity, and is legally responsible
1778 for the entity’s compliance with state law for purposes of this
1779 section.
1780 (n) Entities that are owned or controlled, directly or
1781 indirectly, by a publicly traded entity with $100 million or
1782 more, in the aggregate, in total annual revenues derived from
1783 providing health care services by licensed health care
1784 practitioners that are employed or contracted by an entity
1785 described in this paragraph.
1786 (7) “Portable health service or equipment provider” means
1787 an entity that contracts with or employs persons to provide
1788 portable health care services or equipment to multiple locations
1789 performing treatment or diagnostic testing of individuals, that
1790 bills third-party payors for those services, and that otherwise
1791 meets the definition of a clinic in subsection (4).
1792 Section 50. Paragraph (b) of subsection (1) and paragraph
1793 (c) of subsection (4) of section 400.991, Florida Statutes, are
1794 amended to read:
1795 400.991 License requirements; background screenings;
1796 prohibitions.—
1797 (1)
1798 (b) Each mobile clinic must obtain a separate health care
1799 clinic license and must provide to the agency, at least
1800 quarterly, its projected street location to enable the agency to
1801 locate and inspect such clinic. A portable health service or
1802 equipment provider must obtain a health care clinic license for
1803 a single administrative office and is not required to submit
1804 quarterly projected street locations.
1805 (4) In addition to the requirements of part II of chapter
1806 408, the applicant must file with the application satisfactory
1807 proof that the clinic is in compliance with this part and
1808 applicable rules, including:
1809 (c) Proof of financial ability to operate as required under
1810 ss. s. 408.810(8) and 408.8065. As an alternative to submitting
1811 proof of financial ability to operate as required under s.
1812 408.810(8), the applicant may file a surety bond of at least
1813 $500,000 which guarantees that the clinic will act in full
1814 conformity with all legal requirements for operating a clinic,
1815 payable to the agency. The agency may adopt rules to specify
1816 related requirements for such surety bond.
1817 Section 51. Paragraph (g) of subsection (1) and paragraph
1818 (a) of subsection (7) of section 400.9935, Florida Statutes, are
1819 amended to read:
1820 400.9935 Clinic responsibilities.—
1821 (1) Each clinic shall appoint a medical director or clinic
1822 director who shall agree in writing to accept legal
1823 responsibility for the following activities on behalf of the
1824 clinic. The medical director or the clinic director shall:
1825 (g) Conduct systematic reviews of clinic billings to ensure
1826 that the billings are not fraudulent or unlawful. Upon discovery
1827 of an unlawful charge, the medical director or clinic director
1828 shall take immediate corrective action. If the clinic performs
1829 only the technical component of magnetic resonance imaging,
1830 static radiographs, computed tomography, or positron emission
1831 tomography, and provides the professional interpretation of such
1832 services, in a fixed facility that is accredited by The Joint
1833 Commission on Accreditation of Healthcare Organizations or the
1834 Accreditation Association for Ambulatory Health Care, and the
1835 American College of Radiology; and if, in the preceding quarter,
1836 the percentage of scans performed by that clinic which was
1837 billed to all personal injury protection insurance carriers was
1838 less than 15 percent, the chief financial officer of the clinic
1839 may, in a written acknowledgment provided to the agency, assume
1840 the responsibility for the conduct of the systematic reviews of
1841 clinic billings to ensure that the billings are not fraudulent
1842 or unlawful.
1843 (7)(a) Each clinic engaged in magnetic resonance imaging
1844 services must be accredited by The Joint Commission on
1845 Accreditation of Healthcare Organizations, the American College
1846 of Radiology, or the Accreditation Association for Ambulatory
1847 Health Care, within 1 year after licensure. A clinic that is
1848 accredited by the American College of Radiology or is within the
1849 original 1-year period after licensure and replaces its core
1850 magnetic resonance imaging equipment shall be given 1 year after
1851 the date on which the equipment is replaced to attain
1852 accreditation. However, a clinic may request a single, 6-month
1853 extension if it provides evidence to the agency establishing
1854 that, for good cause shown, such clinic cannot be accredited
1855 within 1 year after licensure, and that such accreditation will
1856 be completed within the 6-month extension. After obtaining
1857 accreditation as required by this subsection, each such clinic
1858 must maintain accreditation as a condition of renewal of its
1859 license. A clinic that files a change of ownership application
1860 must comply with the original accreditation timeframe
1861 requirements of the transferor. The agency shall deny a change
1862 of ownership application if the clinic is not in compliance with
1863 the accreditation requirements. When a clinic adds, replaces, or
1864 modifies magnetic resonance imaging equipment and the
1865 accreditation agency requires new accreditation, the clinic must
1866 be accredited within 1 year after the date of the addition,
1867 replacement, or modification but may request a single, 6-month
1868 extension if the clinic provides evidence of good cause to the
1869 agency.
1870 Section 52. Subsection (2) of section 408.034, Florida
1871 Statutes, is amended to read:
1872 408.034 Duties and responsibilities of agency; rules.—
1873 (2) In the exercise of its authority to issue licenses to
1874 health care facilities and health service providers, as provided
1875 under chapters 393 and 395 and parts II, and IV, and VIII of
1876 chapter 400, the agency may not issue a license to any health
1877 care facility or health service provider that fails to receive a
1878 certificate of need or an exemption for the licensed facility or
1879 service.
1880 Section 53. Paragraph (d) of subsection (1) of section
1881 408.036, Florida Statutes, is amended to read:
1882 408.036 Projects subject to review; exemptions.—
1883 (1) APPLICABILITY.—Unless exempt under subsection (3), all
1884 health-care-related projects, as described in paragraphs (a)
1885 (g), are subject to review and must file an application for a
1886 certificate of need with the agency. The agency is exclusively
1887 responsible for determining whether a health-care-related
1888 project is subject to review under ss. 408.031-408.045.
1889 (d) The establishment of a hospice or hospice inpatient
1890 facility, except as provided in s. 408.043.
1891 Section 54. Subsection (2) of section 408.043, Florida
1892 Statutes, is amended to read:
1893 408.043 Special provisions.—
1894 (2) HOSPICES.—When an application is made for a certificate
1895 of need to establish or to expand a hospice, the need for such
1896 hospice shall be determined on the basis of the need for and
1897 availability of hospice services in the community. The formula
1898 on which the certificate of need is based shall discourage
1899 regional monopolies and promote competition. The inpatient
1900 hospice care component of a hospice which is a freestanding
1901 facility, or a part of a facility, which is primarily engaged in
1902 providing inpatient care and related services and is not
1903 licensed as a health care facility shall also be required to
1904 obtain a certificate of need. Provision of hospice care by any
1905 current provider of health care is a significant change in
1906 service and therefore requires a certificate of need for such
1907 services.
1908 Section 55. Paragraph (k) of subsection (3) of section
1909 408.05, Florida Statutes, is amended to read:
1910 408.05 Florida Center for Health Information and Policy
1911 Analysis.—
1912 (3) COMPREHENSIVE HEALTH INFORMATION SYSTEM.—In order to
1913 produce comparable and uniform health information and statistics
1914 for the development of policy recommendations, the agency shall
1915 perform the following functions:
1916 (k) Develop, in conjunction with the State Consumer Health
1917 Information and Policy Advisory Council, and implement a long
1918 range plan for making available health care quality measures and
1919 financial data that will allow consumers to compare health care
1920 services. The health care quality measures and financial data
1921 the agency must make available shall include, but is not limited
1922 to, pharmaceuticals, physicians, health care facilities, and
1923 health plans and managed care entities. The agency shall submit
1924 the initial plan to the Governor, the President of the Senate,
1925 and the Speaker of the House of Representatives by January 1,
1926 2006, and shall update the plan and report on the status of its
1927 implementation annually thereafter. The agency shall also make
1928 the plan and status report available to the public on its
1929 Internet website. As part of the plan, the agency shall identify
1930 the process and timeframes for implementation, any barriers to
1931 implementation, and recommendations of changes in the law that
1932 may be enacted by the Legislature to eliminate the barriers. As
1933 preliminary elements of the plan, the agency shall:
1934 1. Make available patient-safety indicators, inpatient
1935 quality indicators, and performance outcome and patient charge
1936 data collected from health care facilities pursuant to s.
1937 408.061(1)(a) and (2). The terms “patient-safety indicators” and
1938 “inpatient quality indicators” shall be as defined by the
1939 Centers for Medicare and Medicaid Services, the National Quality
1940 Forum, The Joint Commission on Accreditation of Healthcare
1941 Organizations, the Agency for Healthcare Research and Quality,
1942 the Centers for Disease Control and Prevention, or a similar
1943 national entity that establishes standards to measure the
1944 performance of health care providers, or by other states. The
1945 agency shall determine which conditions, procedures, health care
1946 quality measures, and patient charge data to disclose based upon
1947 input from the council. When determining which conditions and
1948 procedures are to be disclosed, the council and the agency shall
1949 consider variation in costs, variation in outcomes, and
1950 magnitude of variations and other relevant information. When
1951 determining which health care quality measures to disclose, the
1952 agency:
1953 a. Shall consider such factors as volume of cases; average
1954 patient charges; average length of stay; complication rates;
1955 mortality rates; and infection rates, among others, which shall
1956 be adjusted for case mix and severity, if applicable.
1957 b. May consider such additional measures that are adopted
1958 by the Centers for Medicare and Medicaid Studies, National
1959 Quality Forum, The Joint Commission on Accreditation of
1960 Healthcare Organizations, the Agency for Healthcare Research and
1961 Quality, Centers for Disease Control and Prevention, or a
1962 similar national entity that establishes standards to measure
1963 the performance of health care providers, or by other states.
1964
1965 When determining which patient charge data to disclose, the
1966 agency shall include such measures as the average of
1967 undiscounted charges on frequently performed procedures and
1968 preventive diagnostic procedures, the range of procedure charges
1969 from highest to lowest, average net revenue per adjusted patient
1970 day, average cost per adjusted patient day, and average cost per
1971 admission, among others.
1972 2. Make available performance measures, benefit design, and
1973 premium cost data from health plans licensed pursuant to chapter
1974 627 or chapter 641. The agency shall determine which health care
1975 quality measures and member and subscriber cost data to
1976 disclose, based upon input from the council. When determining
1977 which data to disclose, the agency shall consider information
1978 that may be required by either individual or group purchasers to
1979 assess the value of the product, which may include membership
1980 satisfaction, quality of care, current enrollment or membership,
1981 coverage areas, accreditation status, premium costs, plan costs,
1982 premium increases, range of benefits, copayments and
1983 deductibles, accuracy and speed of claims payment, credentials
1984 of physicians, number of providers, names of network providers,
1985 and hospitals in the network. Health plans shall make available
1986 to the agency any such data or information that is not currently
1987 reported to the agency or the office.
1988 3. Determine the method and format for public disclosure of
1989 data reported pursuant to this paragraph. The agency shall make
1990 its determination based upon input from the State Consumer
1991 Health Information and Policy Advisory Council. At a minimum,
1992 the data shall be made available on the agency’s Internet
1993 website in a manner that allows consumers to conduct an
1994 interactive search that allows them to view and compare the
1995 information for specific providers. The website must include
1996 such additional information as is determined necessary to ensure
1997 that the website enhances informed decisionmaking among
1998 consumers and health care purchasers, which shall include, at a
1999 minimum, appropriate guidance on how to use the data and an
2000 explanation of why the data may vary from provider to provider.
2001 The data specified in subparagraph 1. shall be released no later
2002 than January 1, 2006, for the reporting of infection rates, and
2003 no later than October 1, 2005, for mortality rates and
2004 complication rates. The data specified in subparagraph 2. shall
2005 be released no later than October 1, 2006.
2006 4. Publish on its website undiscounted charges for no fewer
2007 than 150 of the most commonly performed adult and pediatric
2008 procedures, including outpatient, inpatient, diagnostic, and
2009 preventative procedures.
2010 Section 56. Paragraph (a) of subsection (1) of section
2011 408.061, Florida Statutes, is amended to read:
2012 408.061 Data collection; uniform systems of financial
2013 reporting; information relating to physician charges;
2014 confidential information; immunity.—
2015 (1) The agency shall require the submission by health care
2016 facilities, health care providers, and health insurers of data
2017 necessary to carry out the agency’s duties. Specifications for
2018 data to be collected under this section shall be developed by
2019 the agency with the assistance of technical advisory panels
2020 including representatives of affected entities, consumers,
2021 purchasers, and such other interested parties as may be
2022 determined by the agency.
2023 (a) Data submitted by health care facilities, including the
2024 facilities as defined in chapter 395, shall include, but are not
2025 limited to: case-mix data, patient admission and discharge data,
2026 hospital emergency department data which shall include the
2027 number of patients treated in the emergency department of a
2028 licensed hospital reported by patient acuity level, data on
2029 hospital-acquired infections as specified by rule, data on
2030 complications as specified by rule, data on readmissions as
2031 specified by rule, with patient and provider-specific
2032 identifiers included, actual charge data by diagnostic groups,
2033 financial data, accounting data, operating expenses, expenses
2034 incurred for rendering services to patients who cannot or do not
2035 pay, interest charges, depreciation expenses based on the
2036 expected useful life of the property and equipment involved, and
2037 demographic data. The agency shall adopt nationally recognized
2038 risk adjustment methodologies or software consistent with the
2039 standards of the Agency for Healthcare Research and Quality and
2040 as selected by the agency for all data submitted as required by
2041 this section. Data may be obtained from documents such as, but
2042 not limited to: leases, contracts, debt instruments, itemized
2043 patient bills, medical record abstracts, and related diagnostic
2044 information. Reported data elements shall be reported
2045 electronically and in accordance with rule 59E-7.012, Florida
2046 Administrative Code. Data submitted shall be certified by the
2047 chief executive officer or an appropriate and duly authorized
2048 representative or employee of the licensed facility that the
2049 information submitted is true and accurate.
2050 Section 57. Subsection (43) of section 408.07, Florida
2051 Statutes, is amended to read:
2052 408.07 Definitions.—As used in this chapter, with the
2053 exception of ss. 408.031-408.045, the term:
2054 (43) “Rural hospital” means an acute care hospital licensed
2055 under chapter 395, having 100 or fewer licensed beds and an
2056 emergency room, and which is:
2057 (a) The sole provider within a county with a population
2058 density of no greater than 100 persons per square mile;
2059 (b) An acute care hospital, in a county with a population
2060 density of no greater than 100 persons per square mile, which is
2061 at least 30 minutes of travel time, on normally traveled roads
2062 under normal traffic conditions, from another acute care
2063 hospital within the same county;
2064 (c) A hospital supported by a tax district or subdistrict
2065 whose boundaries encompass a population of 100 persons or fewer
2066 per square mile;
2067 (d) A hospital with a service area that has a population of
2068 100 persons or fewer per square mile. As used in this paragraph,
2069 the term “service area” means the fewest number of zip codes
2070 that account for 75 percent of the hospital’s discharges for the
2071 most recent 5-year period, based on information available from
2072 the hospital inpatient discharge database in the Florida Center
2073 for Health Information and Policy Analysis at the Agency for
2074 Health Care Administration; or
2075 (e) A critical access hospital.
2076
2077 Population densities used in this subsection must be based upon
2078 the most recently completed United States census. A hospital
2079 that received funds under s. 409.9116 for a quarter beginning no
2080 later than July 1, 2002, is deemed to have been and shall
2081 continue to be a rural hospital from that date through June 30,
2082 2015, if the hospital continues to have 100 or fewer licensed
2083 beds and an emergency room, or meets the criteria of s.
2084 395.602(2)(e)4. An acute care hospital that has not previously
2085 been designated as a rural hospital and that meets the criteria
2086 of this subsection shall be granted such designation upon
2087 application, including supporting documentation, to the Agency
2088 for Health Care Administration.
2089 Section 58. Section 408.10, Florida Statutes, is amended to
2090 read:
2091 408.10 Consumer complaints.—The agency shall:
2092 (1) publish and make available to the public a toll-free
2093 telephone number for the purpose of handling consumer complaints
2094 and shall serve as a liaison between consumer entities and other
2095 private entities and governmental entities for the disposition
2096 of problems identified by consumers of health care.
2097 (2) Be empowered to investigate consumer complaints
2098 relating to problems with health care facilities’ billing
2099 practices and issue reports to be made public in any cases where
2100 the agency determines the health care facility has engaged in
2101 billing practices which are unreasonable and unfair to the
2102 consumer.
2103 Section 59. Subsections (12) through (30) of section
2104 408.802, Florida Statutes, are renumbered as subsections (11)
2105 through (29), respectively, and present subsection (11) of that
2106 section is amended to read:
2107 408.802 Applicability.—The provisions of this part apply to
2108 the provision of services that require licensure as defined in
2109 this part and to the following entities licensed, registered, or
2110 certified by the agency, as described in chapters 112, 383, 390,
2111 394, 395, 400, 429, 440, 483, and 765:
2112 (11) Private review agents, as provided under part I of
2113 chapter 395.
2114 Section 60. Subsection (3) is added to section 408.804,
2115 Florida Statutes, to read:
2116 408.804 License required; display.—
2117 (3) Any person who knowingly alters, defaces, or falsifies
2118 a license certificate issued by the agency, or causes or
2119 procures any person to commit such an offense, commits a
2120 misdemeanor of the second degree, punishable as provided in s.
2121 775.082 or s 775.083. Any licensee or provider who displays an
2122 altered, defaced, or falsified license certificate is subject to
2123 the penalties set forth in s. 408.815 and an administrative fine
2124 of $1,000 for each day of illegal display.
2125 Section 61. Paragraph (d) of subsection (2) of section
2126 408.806, Florida Statutes, is amended, present subsections (3)
2127 through (8) are renumbered as subsections (4) through (9),
2128 respectively, and a new subsection (3) is added to that section,
2129 to read:
2130 408.806 License application process.—
2131 (2)
2132 (d) The agency shall notify the licensee by mail or
2133 electronically at least 90 days before the expiration of a
2134 license that a renewal license is necessary to continue
2135 operation. The licensee’s failure to timely file submit a
2136 renewal application and license application fee with the agency
2137 shall result in a $50 per day late fee charged to the licensee
2138 by the agency; however, the aggregate amount of the late fee may
2139 not exceed 50 percent of the licensure fee or $500, whichever is
2140 less. The agency shall provide a courtesy notice to the licensee
2141 by United States mail, electronically, or by any other manner at
2142 its address of record or mailing address, if provided, at least
2143 90 days prior to the expiration of a license informing the
2144 licensee of the expiration of the license. If the agency does
2145 not provide the courtesy notice or the licensee does not receive
2146 the courtesy notice, the licensee continues to be legally
2147 obligated to timely file the renewal application and license
2148 application fee with the agency and is not excused from the
2149 payment of a late fee. If an application is received after the
2150 required filing date and exhibits a hand-canceled postmark
2151 obtained from a United States post office dated on or before the
2152 required filing date, no fine will be levied.
2153 (3) Payment of the late fee is required to consider any
2154 late application complete, and failure to pay the late fee is
2155 considered an omission from the application.
2156 Section 62. Subsections (6) and (9) of section 408.810,
2157 Florida Statutes, are amended to read:
2158 408.810 Minimum licensure requirements.—In addition to the
2159 licensure requirements specified in this part, authorizing
2160 statutes, and applicable rules, each applicant and licensee must
2161 comply with the requirements of this section in order to obtain
2162 and maintain a license.
2163 (6)(a) An applicant must provide the agency with proof of
2164 the applicant’s legal right to occupy the property before a
2165 license may be issued. Proof may include, but need not be
2166 limited to, copies of warranty deeds, lease or rental
2167 agreements, contracts for deeds, quitclaim deeds, or other such
2168 documentation.
2169 (b) In the event the property is encumbered by a mortgage
2170 or is leased, an applicant must provide the agency with proof
2171 that the mortgagor or landlord has been provided written notice
2172 of the applicant’s intent as mortgagee or tenant to provide
2173 services that require licensure and instruct the mortgagor or
2174 landlord to serve the agency by certified mail with copies of
2175 any foreclosure or eviction actions initiated by the mortgagor
2176 or landlord against the applicant.
2177 (9) A controlling interest may not withhold from the agency
2178 any evidence of financial instability, including, but not
2179 limited to, checks returned due to insufficient funds,
2180 delinquent accounts, nonpayment of withholding taxes, unpaid
2181 utility expenses, nonpayment for essential services, or adverse
2182 court action concerning the financial viability of the provider
2183 or any other provider licensed under this part that is under the
2184 control of the controlling interest. A controlling interest
2185 shall notify the agency within 10 days after a court action to
2186 initiate bankruptcy, foreclosure, or eviction proceedings
2187 concerning the provider, in which the controlling interest is a
2188 petitioner or defendant. Any person who violates this subsection
2189 commits a misdemeanor of the second degree, punishable as
2190 provided in s. 775.082 or s. 775.083. Each day of continuing
2191 violation is a separate offense.
2192 Section 63. Subsection (3) is added to section 408.813,
2193 Florida Statutes, to read:
2194 408.813 Administrative fines; violations.—As a penalty for
2195 any violation of this part, authorizing statutes, or applicable
2196 rules, the agency may impose an administrative fine.
2197 (3) The agency may impose an administrative fine for a
2198 violation that does not qualify as a class I, class II, class
2199 III, or class IV violation. Unless otherwise specified by law,
2200 the amount of the fine shall not exceed $500 for each violation.
2201 Unclassified violations may include:
2202 (a) Violating any term or condition of a license.
2203 (b) Violating any provision of this part, authorizing
2204 statutes, or applicable rules.
2205 (c) Exceeding licensed capacity.
2206 (d) Providing services beyond the scope of the license.
2207 (e) Violating a moratorium imposed pursuant to s. 408.814.
2208 Section 64. Subsection (5) is added to section 408.815,
2209 Florida Statutes, to read:
2210 408.815 License or application denial; revocation.—
2211 (5) In order to ensure the health, safety, and welfare of
2212 clients when a license has been denied, revoked, or is set to
2213 terminate, the agency may extend the license expiration date for
2214 a period of up to 30 days for the sole purpose of allowing the
2215 safe and orderly discharge of clients. The agency may impose
2216 conditions on the extension, including, but not limited to,
2217 prohibiting or limiting admissions, expedited discharge
2218 planning, required status reports, and mandatory monitoring by
2219 the agency or third parties. In imposing these conditions, the
2220 agency shall take into consideration the nature and number of
2221 clients, the availability and location of acceptable alternative
2222 placements, and the ability of the licensee to continue
2223 providing care to the clients. The agency may terminate the
2224 extension or modify the conditions at any time. This authority
2225 is in addition to any other authority granted to the agency
2226 under chapter 120, this part, and authorizing statutes but
2227 creates no right or entitlement to an extension of a license
2228 expiration date.
2229 Section 65. Paragraph (k) of subsection (4) of section
2230 409.221, Florida Statutes, is amended to read:
2231 409.221 Consumer-directed care program.—
2232 (4) CONSUMER-DIRECTED CARE.—
2233 (k) Reviews and reports.—The agency and the Departments of
2234 Elderly Affairs, Health, and Children and Family Services and
2235 the Agency for Persons with Disabilities shall each, on an
2236 ongoing basis, review and assess the implementation of the
2237 consumer-directed care program. By January 15 of each year, the
2238 agency shall submit a written report to the Legislature that
2239 includes each department’s review of the program and contains
2240 recommendations for improvements to the program.
2241 Section 66. Subsection (1) of section 409.91196, Florida
2242 Statutes, is amended to read:
2243 409.91196 Supplemental rebate agreements; public records
2244 and public meetings exemption.—
2245 (1) The rebate amount, percent of rebate, manufacturer’s
2246 pricing, and supplemental rebate, and other trade secrets as
2247 defined in s. 688.002 that the agency has identified for use in
2248 negotiations, held by the Agency for Health Care Administration
2249 under s. 409.912(39)(a)8.7. are confidential and exempt from s.
2250 119.07(1) and s. 24(a), Art. I of the State Constitution.
2251 Section 67. Paragraph (a) of subsection (39) of section
2252 409.912, Florida Statutes, is amended to read:
2253 409.912 Cost-effective purchasing of health care.—The
2254 agency shall purchase goods and services for Medicaid recipients
2255 in the most cost-effective manner consistent with the delivery
2256 of quality medical care. To ensure that medical services are
2257 effectively utilized, the agency may, in any case, require a
2258 confirmation or second physician’s opinion of the correct
2259 diagnosis for purposes of authorizing future services under the
2260 Medicaid program. This section does not restrict access to
2261 emergency services or poststabilization care services as defined
2262 in 42 C.F.R. part 438.114. Such confirmation or second opinion
2263 shall be rendered in a manner approved by the agency. The agency
2264 shall maximize the use of prepaid per capita and prepaid
2265 aggregate fixed-sum basis services when appropriate and other
2266 alternative service delivery and reimbursement methodologies,
2267 including competitive bidding pursuant to s. 287.057, designed
2268 to facilitate the cost-effective purchase of a case-managed
2269 continuum of care. The agency shall also require providers to
2270 minimize the exposure of recipients to the need for acute
2271 inpatient, custodial, and other institutional care and the
2272 inappropriate or unnecessary use of high-cost services. The
2273 agency shall contract with a vendor to monitor and evaluate the
2274 clinical practice patterns of providers in order to identify
2275 trends that are outside the normal practice patterns of a
2276 provider’s professional peers or the national guidelines of a
2277 provider’s professional association. The vendor must be able to
2278 provide information and counseling to a provider whose practice
2279 patterns are outside the norms, in consultation with the agency,
2280 to improve patient care and reduce inappropriate utilization.
2281 The agency may mandate prior authorization, drug therapy
2282 management, or disease management participation for certain
2283 populations of Medicaid beneficiaries, certain drug classes, or
2284 particular drugs to prevent fraud, abuse, overuse, and possible
2285 dangerous drug interactions. The Pharmaceutical and Therapeutics
2286 Committee shall make recommendations to the agency on drugs for
2287 which prior authorization is required. The agency shall inform
2288 the Pharmaceutical and Therapeutics Committee of its decisions
2289 regarding drugs subject to prior authorization. The agency is
2290 authorized to limit the entities it contracts with or enrolls as
2291 Medicaid providers by developing a provider network through
2292 provider credentialing. The agency may competitively bid single
2293 source-provider contracts if procurement of goods or services
2294 results in demonstrated cost savings to the state without
2295 limiting access to care. The agency may limit its network based
2296 on the assessment of beneficiary access to care, provider
2297 availability, provider quality standards, time and distance
2298 standards for access to care, the cultural competence of the
2299 provider network, demographic characteristics of Medicaid
2300 beneficiaries, practice and provider-to-beneficiary standards,
2301 appointment wait times, beneficiary use of services, provider
2302 turnover, provider profiling, provider licensure history,
2303 previous program integrity investigations and findings, peer
2304 review, provider Medicaid policy and billing compliance records,
2305 clinical and medical record audits, and other factors. Providers
2306 shall not be entitled to enrollment in the Medicaid provider
2307 network. The agency shall determine instances in which allowing
2308 Medicaid beneficiaries to purchase durable medical equipment and
2309 other goods is less expensive to the Medicaid program than long
2310 term rental of the equipment or goods. The agency may establish
2311 rules to facilitate purchases in lieu of long-term rentals in
2312 order to protect against fraud and abuse in the Medicaid program
2313 as defined in s. 409.913. The agency may seek federal waivers
2314 necessary to administer these policies.
2315 (39)(a) The agency shall implement a Medicaid prescribed
2316 drug spending-control program that includes the following
2317 components:
2318 1. A Medicaid preferred drug list, which shall be a listing
2319 of cost-effective therapeutic options recommended by the
2320 Medicaid Pharmacy and Therapeutics Committee established
2321 pursuant to s. 409.91195 and adopted by the agency for each
2322 therapeutic class on the preferred drug list. At the discretion
2323 of the committee, and when feasible, the preferred drug list
2324 should include at least two products in a therapeutic class. The
2325 agency may post the preferred drug list and updates to the
2326 preferred drug list on an Internet website without following the
2327 rulemaking procedures of chapter 120. Antiretroviral agents are
2328 excluded from the preferred drug list. The agency shall also
2329 limit the amount of a prescribed drug dispensed to no more than
2330 a 34-day supply unless the drug products’ smallest marketed
2331 package is greater than a 34-day supply, or the drug is
2332 determined by the agency to be a maintenance drug in which case
2333 a 100-day maximum supply may be authorized. The agency is
2334 authorized to seek any federal waivers necessary to implement
2335 these cost-control programs and to continue participation in the
2336 federal Medicaid rebate program, or alternatively to negotiate
2337 state-only manufacturer rebates. The agency may adopt rules to
2338 implement this subparagraph. The agency shall continue to
2339 provide unlimited contraceptive drugs and items. The agency must
2340 establish procedures to ensure that:
2341 a. There is a response to a request for prior consultation
2342 by telephone or other telecommunication device within 24 hours
2343 after receipt of a request for prior consultation; and
2344 b. A 72-hour supply of the drug prescribed is provided in
2345 an emergency or when the agency does not provide a response
2346 within 24 hours as required by sub-subparagraph a.
2347 2. Reimbursement to pharmacies for Medicaid prescribed
2348 drugs shall be set at the lesser of: the average wholesale price
2349 (AWP) minus 16.4 percent, the wholesaler acquisition cost (WAC)
2350 plus 4.75 percent, the federal upper limit (FUL), the state
2351 maximum allowable cost (SMAC), or the usual and customary (UAC)
2352 charge billed by the provider.
2353 3. For a prescribed drug billed as a 340B prescribed
2354 medication, the claim must meet the requirements of the Deficit
2355 Reduction Act of 2005 and the federal 340B program, contain a
2356 national drug code, and be billed at the actual acquisition cost
2357 or payment shall be denied.
2358 4.3. The agency shall develop and implement a process for
2359 managing the drug therapies of Medicaid recipients who are using
2360 significant numbers of prescribed drugs each month. The
2361 management process may include, but is not limited to,
2362 comprehensive, physician-directed medical-record reviews, claims
2363 analyses, and case evaluations to determine the medical
2364 necessity and appropriateness of a patient’s treatment plan and
2365 drug therapies. The agency may contract with a private
2366 organization to provide drug-program-management services. The
2367 Medicaid drug benefit management program shall include
2368 initiatives to manage drug therapies for HIV/AIDS patients,
2369 patients using 20 or more unique prescriptions in a 180-day
2370 period, and the top 1,000 patients in annual spending. The
2371 agency shall enroll any Medicaid recipient in the drug benefit
2372 management program if he or she meets the specifications of this
2373 provision and is not enrolled in a Medicaid health maintenance
2374 organization.
2375 5.4. The agency may limit the size of its pharmacy network
2376 based on need, competitive bidding, price negotiations,
2377 credentialing, or similar criteria. The agency shall give
2378 special consideration to rural areas in determining the size and
2379 location of pharmacies included in the Medicaid pharmacy
2380 network. A pharmacy credentialing process may include criteria
2381 such as a pharmacy’s full-service status, location, size,
2382 patient educational programs, patient consultation, disease
2383 management services, and other characteristics. The agency may
2384 impose a moratorium on Medicaid pharmacy enrollment when it is
2385 determined that it has a sufficient number of Medicaid
2386 participating providers. The agency must allow dispensing
2387 practitioners to participate as a part of the Medicaid pharmacy
2388 network regardless of the practitioner’s proximity to any other
2389 entity that is dispensing prescription drugs under the Medicaid
2390 program. A dispensing practitioner must meet all credentialing
2391 requirements applicable to his or her practice, as determined by
2392 the agency.
2393 6.5. The agency shall develop and implement a program that
2394 requires Medicaid practitioners who prescribe drugs to use a
2395 counterfeit-proof prescription pad for Medicaid prescriptions.
2396 The agency shall require the use of standardized counterfeit
2397 proof prescription pads by Medicaid-participating prescribers or
2398 prescribers who write prescriptions for Medicaid recipients. The
2399 agency may implement the program in targeted geographic areas or
2400 statewide.
2401 7.6. The agency may enter into arrangements that require
2402 manufacturers of generic drugs prescribed to Medicaid recipients
2403 to provide rebates of at least 15.1 percent of the average
2404 manufacturer price for the manufacturer’s generic products.
2405 These arrangements shall require that if a generic-drug
2406 manufacturer pays federal rebates for Medicaid-reimbursed drugs
2407 at a level below 15.1 percent, the manufacturer must provide a
2408 supplemental rebate to the state in an amount necessary to
2409 achieve a 15.1-percent rebate level.
2410 8.7. The agency may establish a preferred drug list as
2411 described in this subsection, and, pursuant to the establishment
2412 of such preferred drug list, it is authorized to negotiate
2413 supplemental rebates from manufacturers that are in addition to
2414 those required by Title XIX of the Social Security Act and at no
2415 less than 14 percent of the average manufacturer price as
2416 defined in 42 U.S.C. s. 1936 on the last day of a quarter unless
2417 the federal or supplemental rebate, or both, equals or exceeds
2418 29 percent. There is no upper limit on the supplemental rebates
2419 the agency may negotiate. The agency may determine that specific
2420 products, brand-name or generic, are competitive at lower rebate
2421 percentages. Agreement to pay the minimum supplemental rebate
2422 percentage will guarantee a manufacturer that the Medicaid
2423 Pharmaceutical and Therapeutics Committee will consider a
2424 product for inclusion on the preferred drug list. However, a
2425 pharmaceutical manufacturer is not guaranteed placement on the
2426 preferred drug list by simply paying the minimum supplemental
2427 rebate. Agency decisions will be made on the clinical efficacy
2428 of a drug and recommendations of the Medicaid Pharmaceutical and
2429 Therapeutics Committee, as well as the price of competing
2430 products minus federal and state rebates. The agency is
2431 authorized to contract with an outside agency or contractor to
2432 conduct negotiations for supplemental rebates. For the purposes
2433 of this section, the term “supplemental rebates” means cash
2434 rebates. Effective July 1, 2004, value-added programs as a
2435 substitution for supplemental rebates are prohibited. The agency
2436 is authorized to seek any federal waivers to implement this
2437 initiative.
2438 9.8. The Agency for Health Care Administration shall expand
2439 home delivery of pharmacy products. To assist Medicaid patients
2440 in securing their prescriptions and reduce program costs, the
2441 agency shall expand its current mail-order-pharmacy diabetes
2442 supply program to include all generic and brand-name drugs used
2443 by Medicaid patients with diabetes. Medicaid recipients in the
2444 current program may obtain nondiabetes drugs on a voluntary
2445 basis. This initiative is limited to the geographic area covered
2446 by the current contract. The agency may seek and implement any
2447 federal waivers necessary to implement this subparagraph.
2448 10.9. The agency shall limit to one dose per month any drug
2449 prescribed to treat erectile dysfunction.
2450 11.10.a. The agency may implement a Medicaid behavioral
2451 drug management system. The agency may contract with a vendor
2452 that has experience in operating behavioral drug management
2453 systems to implement this program. The agency is authorized to
2454 seek federal waivers to implement this program.
2455 b. The agency, in conjunction with the Department of
2456 Children and Family Services, may implement the Medicaid
2457 behavioral drug management system that is designed to improve
2458 the quality of care and behavioral health prescribing practices
2459 based on best practice guidelines, improve patient adherence to
2460 medication plans, reduce clinical risk, and lower prescribed
2461 drug costs and the rate of inappropriate spending on Medicaid
2462 behavioral drugs. The program may include the following
2463 elements:
2464 (I) Provide for the development and adoption of best
2465 practice guidelines for behavioral health-related drugs such as
2466 antipsychotics, antidepressants, and medications for treating
2467 bipolar disorders and other behavioral conditions; translate
2468 them into practice; review behavioral health prescribers and
2469 compare their prescribing patterns to a number of indicators
2470 that are based on national standards; and determine deviations
2471 from best practice guidelines.
2472 (II) Implement processes for providing feedback to and
2473 educating prescribers using best practice educational materials
2474 and peer-to-peer consultation.
2475 (III) Assess Medicaid beneficiaries who are outliers in
2476 their use of behavioral health drugs with regard to the numbers
2477 and types of drugs taken, drug dosages, combination drug
2478 therapies, and other indicators of improper use of behavioral
2479 health drugs.
2480 (IV) Alert prescribers to patients who fail to refill
2481 prescriptions in a timely fashion, are prescribed multiple same
2482 class behavioral health drugs, and may have other potential
2483 medication problems.
2484 (V) Track spending trends for behavioral health drugs and
2485 deviation from best practice guidelines.
2486 (VI) Use educational and technological approaches to
2487 promote best practices, educate consumers, and train prescribers
2488 in the use of practice guidelines.
2489 (VII) Disseminate electronic and published materials.
2490 (VIII) Hold statewide and regional conferences.
2491 (IX) Implement a disease management program with a model
2492 quality-based medication component for severely mentally ill
2493 individuals and emotionally disturbed children who are high
2494 users of care.
2495 12.11.a. The agency shall implement a Medicaid prescription
2496 drug management system. The agency may contract with a vendor
2497 that has experience in operating prescription drug management
2498 systems in order to implement this system. Any management system
2499 that is implemented in accordance with this subparagraph must
2500 rely on cooperation between physicians and pharmacists to
2501 determine appropriate practice patterns and clinical guidelines
2502 to improve the prescribing, dispensing, and use of drugs in the
2503 Medicaid program. The agency may seek federal waivers to
2504 implement this program.
2505 b. The drug management system must be designed to improve
2506 the quality of care and prescribing practices based on best
2507 practice guidelines, improve patient adherence to medication
2508 plans, reduce clinical risk, and lower prescribed drug costs and
2509 the rate of inappropriate spending on Medicaid prescription
2510 drugs. The program must:
2511 (I) Provide for the development and adoption of best
2512 practice guidelines for the prescribing and use of drugs in the
2513 Medicaid program, including translating best practice guidelines
2514 into practice; reviewing prescriber patterns and comparing them
2515 to indicators that are based on national standards and practice
2516 patterns of clinical peers in their community, statewide, and
2517 nationally; and determine deviations from best practice
2518 guidelines.
2519 (II) Implement processes for providing feedback to and
2520 educating prescribers using best practice educational materials
2521 and peer-to-peer consultation.
2522 (III) Assess Medicaid recipients who are outliers in their
2523 use of a single or multiple prescription drugs with regard to
2524 the numbers and types of drugs taken, drug dosages, combination
2525 drug therapies, and other indicators of improper use of
2526 prescription drugs.
2527 (IV) Alert prescribers to patients who fail to refill
2528 prescriptions in a timely fashion, are prescribed multiple drugs
2529 that may be redundant or contraindicated, or may have other
2530 potential medication problems.
2531 (V) Track spending trends for prescription drugs and
2532 deviation from best practice guidelines.
2533 (VI) Use educational and technological approaches to
2534 promote best practices, educate consumers, and train prescribers
2535 in the use of practice guidelines.
2536 (VII) Disseminate electronic and published materials.
2537 (VIII) Hold statewide and regional conferences.
2538 (IX) Implement disease management programs in cooperation
2539 with physicians and pharmacists, along with a model quality
2540 based medication component for individuals having chronic
2541 medical conditions.
2542 13.12. The agency is authorized to contract for drug rebate
2543 administration, including, but not limited to, calculating
2544 rebate amounts, invoicing manufacturers, negotiating disputes
2545 with manufacturers, and maintaining a database of rebate
2546 collections.
2547 14.13. The agency may specify the preferred daily dosing
2548 form or strength for the purpose of promoting best practices
2549 with regard to the prescribing of certain drugs as specified in
2550 the General Appropriations Act and ensuring cost-effective
2551 prescribing practices.
2552 15.14. The agency may require prior authorization for
2553 Medicaid-covered prescribed drugs. The agency may, but is not
2554 required to, prior-authorize the use of a product:
2555 a. For an indication not approved in labeling;
2556 b. To comply with certain clinical guidelines; or
2557 c. If the product has the potential for overuse, misuse, or
2558 abuse.
2559
2560 The agency may require the prescribing professional to provide
2561 information about the rationale and supporting medical evidence
2562 for the use of a drug. The agency may post prior authorization
2563 criteria and protocol and updates to the list of drugs that are
2564 subject to prior authorization on an Internet website without
2565 amending its rule or engaging in additional rulemaking.
2566 16.15. The agency, in conjunction with the Pharmaceutical
2567 and Therapeutics Committee, may require age-related prior
2568 authorizations for certain prescribed drugs. The agency may
2569 preauthorize the use of a drug for a recipient who may not meet
2570 the age requirement or may exceed the length of therapy for use
2571 of this product as recommended by the manufacturer and approved
2572 by the Food and Drug Administration. Prior authorization may
2573 require the prescribing professional to provide information
2574 about the rationale and supporting medical evidence for the use
2575 of a drug.
2576 17.16. The agency shall implement a step-therapy prior
2577 authorization approval process for medications excluded from the
2578 preferred drug list. Medications listed on the preferred drug
2579 list must be used within the previous 12 months prior to the
2580 alternative medications that are not listed. The step-therapy
2581 prior authorization may require the prescriber to use the
2582 medications of a similar drug class or for a similar medical
2583 indication unless contraindicated in the Food and Drug
2584 Administration labeling. The trial period between the specified
2585 steps may vary according to the medical indication. The step
2586 therapy approval process shall be developed in accordance with
2587 the committee as stated in s. 409.91195(7) and (8). A drug
2588 product may be approved without meeting the step-therapy prior
2589 authorization criteria if the prescribing physician provides the
2590 agency with additional written medical or clinical documentation
2591 that the product is medically necessary because:
2592 a. There is not a drug on the preferred drug list to treat
2593 the disease or medical condition which is an acceptable clinical
2594 alternative;
2595 b. The alternatives have been ineffective in the treatment
2596 of the beneficiary’s disease; or
2597 c. Based on historic evidence and known characteristics of
2598 the patient and the drug, the drug is likely to be ineffective,
2599 or the number of doses have been ineffective.
2600
2601 The agency shall work with the physician to determine the best
2602 alternative for the patient. The agency may adopt rules waiving
2603 the requirements for written clinical documentation for specific
2604 drugs in limited clinical situations.
2605 18.17. The agency shall implement a return and reuse
2606 program for drugs dispensed by pharmacies to institutional
2607 recipients, which includes payment of a $5 restocking fee for
2608 the implementation and operation of the program. The return and
2609 reuse program shall be implemented electronically and in a
2610 manner that promotes efficiency. The program must permit a
2611 pharmacy to exclude drugs from the program if it is not
2612 practical or cost-effective for the drug to be included and must
2613 provide for the return to inventory of drugs that cannot be
2614 credited or returned in a cost-effective manner. The agency
2615 shall determine if the program has reduced the amount of
2616 Medicaid prescription drugs which are destroyed on an annual
2617 basis and if there are additional ways to ensure more
2618 prescription drugs are not destroyed which could safely be
2619 reused. The agency’s conclusion and recommendations shall be
2620 reported to the Legislature by December 1, 2005.
2621 Section 68. Subsections (3) and (4) of section 429.07,
2622 Florida Statutes, are amended, and subsections (6) and (7) are
2623 added to that section, to read:
2624 429.07 License required; fee; inspections.—
2625 (3) In addition to the requirements of s. 408.806, each
2626 license granted by the agency must state the type of care for
2627 which the license is granted. Licenses shall be issued for one
2628 or more of the following categories of care: standard, extended
2629 congregate care, limited nursing services, or limited mental
2630 health.
2631 (a) A standard license shall be issued to a facility
2632 facilities providing one or more of the personal services
2633 identified in s. 429.02. Such licensee facilities may also
2634 employ or contract with a person licensed under part I of
2635 chapter 464 to administer medications and perform other tasks as
2636 specified in s. 429.255.
2637 (b) An extended congregate care license shall be issued to
2638 a licensee facilities providing, directly or through contract,
2639 services beyond those authorized in paragraph (a), including
2640 acts performed pursuant to part I of chapter 464 by persons
2641 licensed thereunder, and supportive services defined by rule to
2642 persons who otherwise would be disqualified from continued
2643 residence in a facility licensed under this part.
2644 1. In order for extended congregate care services to be
2645 provided in a facility licensed under this part, the agency must
2646 first determine that all requirements established in law and
2647 rule are met and must specifically designate, on the facility’s
2648 license, that such services may be provided and whether the
2649 designation applies to all or part of a facility. Such
2650 designation may be made at the time of initial licensure or
2651 relicensure, or upon request in writing by a licensee under this
2652 part and part II of chapter 408. Notification of approval or
2653 denial of such request shall be made in accordance with part II
2654 of chapter 408. An existing licensee facilities qualifying to
2655 provide extended congregate care services must have maintained a
2656 standard license and may not have been subject to administrative
2657 sanctions during the previous 2 years, or since initial
2658 licensure if the facility has been licensed for less than 2
2659 years, for any of the following reasons:
2660 a. A class I or class II violation;
2661 b. Three or more repeat or recurring class III violations
2662 of identical or similar resident care standards as specified in
2663 rule from which a pattern of noncompliance is found by the
2664 agency;
2665 c. Three or more class III violations that were not
2666 corrected in accordance with the corrective action plan approved
2667 by the agency;
2668 d. Violation of resident care standards resulting in a
2669 requirement to employ the services of a consultant pharmacist or
2670 consultant dietitian;
2671 e. Denial, suspension, or revocation of a license for
2672 another facility under this part in which the applicant for an
2673 extended congregate care license has at least 25 percent
2674 ownership interest; or
2675 f. Imposition of a moratorium pursuant to this part or part
2676 II of chapter 408 or initiation of injunctive proceedings.
2677 2. A licensee Facilities that is are licensed to provide
2678 extended congregate care services shall maintain a written
2679 progress report for on each person who receives such services,
2680 and the which report must describe describes the type, amount,
2681 duration, scope, and outcome of services that are rendered and
2682 the general status of the resident’s health. A registered nurse,
2683 or appropriate designee, representing the agency shall visit
2684 such facilities at least quarterly to monitor residents who are
2685 receiving extended congregate care services and to determine if
2686 the facility is in compliance with this part, part II of chapter
2687 408, and rules that relate to extended congregate care. One of
2688 these visits may be in conjunction with the regular survey. The
2689 monitoring visits may be provided through contractual
2690 arrangements with appropriate community agencies. A registered
2691 nurse shall serve as part of the team that inspects such
2692 facility. The agency may waive one of the required yearly
2693 monitoring visits for a facility that has been licensed for at
2694 least 24 months to provide extended congregate care services,
2695 if, during the inspection, the registered nurse determines that
2696 extended congregate care services are being provided
2697 appropriately, and if the facility has no class I or class II
2698 violations and no uncorrected class III violations. Before such
2699 decision is made, the agency shall consult with the long-term
2700 care ombudsman council for the area in which the facility is
2701 located to determine if any complaints have been made and
2702 substantiated about the quality of services or care. The agency
2703 may not waive one of the required yearly monitoring visits if
2704 complaints have been made and substantiated.
2705 3. Licensees Facilities that are licensed to provide
2706 extended congregate care services shall:
2707 a. Demonstrate the capability to meet unanticipated
2708 resident service needs.
2709 b. Offer a physical environment that promotes a homelike
2710 setting, provides for resident privacy, promotes resident
2711 independence, and allows sufficient congregate space as defined
2712 by rule.
2713 c. Have sufficient staff available, taking into account the
2714 physical plant and firesafety features of the building, to
2715 assist with the evacuation of residents in an emergency, as
2716 necessary.
2717 d. Adopt and follow policies and procedures that maximize
2718 resident independence, dignity, choice, and decisionmaking to
2719 permit residents to age in place to the extent possible, so that
2720 moves due to changes in functional status are minimized or
2721 avoided.
2722 e. Allow residents or, if applicable, a resident’s
2723 representative, designee, surrogate, guardian, or attorney in
2724 fact to make a variety of personal choices, participate in
2725 developing service plans, and share responsibility in
2726 decisionmaking.
2727 f. Implement the concept of managed risk.
2728 g. Provide, either directly or through contract, the
2729 services of a person licensed pursuant to part I of chapter 464.
2730 h. In addition to the training mandated in s. 429.52,
2731 provide specialized training as defined by rule for facility
2732 staff.
2733 4. Licensees Facilities licensed to provide extended
2734 congregate care services are exempt from the criteria for
2735 continued residency as set forth in rules adopted under s.
2736 429.41. Licensees Facilities so licensed shall adopt their own
2737 requirements within guidelines for continued residency set forth
2738 by rule. However, such licensees facilities may not serve
2739 residents who require 24-hour nursing supervision. Licensees
2740 Facilities licensed to provide extended congregate care services
2741 shall provide each resident with a written copy of facility
2742 policies governing admission and retention.
2743 5. The primary purpose of extended congregate care services
2744 is to allow residents, as they become more impaired, the option
2745 of remaining in a familiar setting from which they would
2746 otherwise be disqualified for continued residency. A facility
2747 licensed to provide extended congregate care services may also
2748 admit an individual who exceeds the admission criteria for a
2749 facility with a standard license, if the individual is
2750 determined appropriate for admission to the extended congregate
2751 care facility.
2752 6. Before admission of an individual to a facility licensed
2753 to provide extended congregate care services, the individual
2754 must undergo a medical examination as provided in s. 429.26(4)
2755 and the facility must develop a preliminary service plan for the
2756 individual.
2757 7. When a licensee facility can no longer provide or
2758 arrange for services in accordance with the resident’s service
2759 plan and needs and the licensee’s facility’s policy, the
2760 licensee facility shall make arrangements for relocating the
2761 person in accordance with s. 429.28(1)(k).
2762 8. Failure to provide extended congregate care services may
2763 result in denial of extended congregate care license renewal.
2764 9. No later than January 1 of each year, the department, in
2765 consultation with the agency, shall prepare and submit to the
2766 Governor, the President of the Senate, the Speaker of the House
2767 of Representatives, and the chairs of appropriate legislative
2768 committees, a report on the status of, and recommendations
2769 related to, extended congregate care services. The status report
2770 must include, but need not be limited to, the following
2771 information:
2772 a. A description of the facilities licensed to provide such
2773 services, including total number of beds licensed under this
2774 part.
2775 b. The number and characteristics of residents receiving
2776 such services.
2777 c. The types of services rendered that could not be
2778 provided through a standard license.
2779 d. An analysis of deficiencies cited during licensure
2780 inspections.
2781 e. The number of residents who required extended congregate
2782 care services at admission and the source of admission.
2783 f. Recommendations for statutory or regulatory changes.
2784 g. The availability of extended congregate care to state
2785 clients residing in facilities licensed under this part and in
2786 need of additional services, and recommendations for
2787 appropriations to subsidize extended congregate care services
2788 for such persons.
2789 h. Such other information as the department considers
2790 appropriate.
2791 (c) A limited nursing services license shall be issued to a
2792 facility that provides services beyond those authorized in
2793 paragraph (a) and as specified in this paragraph.
2794 1. In order for limited nursing services to be provided in
2795 a facility licensed under this part, the agency must first
2796 determine that all requirements established in law and rule are
2797 met and must specifically designate, on the facility’s license,
2798 that such services may be provided. Such designation may be made
2799 at the time of initial licensure or relicensure, or upon request
2800 in writing by a licensee under this part and part II of chapter
2801 408. Notification of approval or denial of such request shall be
2802 made in accordance with part II of chapter 408. Existing
2803 facilities qualifying to provide limited nursing services shall
2804 have maintained a standard license and may not have been subject
2805 to administrative sanctions that affect the health, safety, and
2806 welfare of residents for the previous 2 years or since initial
2807 licensure if the facility has been licensed for less than 2
2808 years.
2809 2. Facilities that are licensed to provide limited nursing
2810 services shall maintain a written progress report on each person
2811 who receives such nursing services, which report describes the
2812 type, amount, duration, scope, and outcome of services that are
2813 rendered and the general status of the resident’s health. A
2814 registered nurse representing the agency shall visit such
2815 facilities at least twice a year to monitor residents who are
2816 receiving limited nursing services and to determine if the
2817 facility is in compliance with applicable provisions of this
2818 part, part II of chapter 408, and related rules. The monitoring
2819 visits may be provided through contractual arrangements with
2820 appropriate community agencies. A registered nurse shall also
2821 serve as part of the team that inspects such facility.
2822 3. A person who receives limited nursing services under
2823 this part must meet the admission criteria established by the
2824 agency for assisted living facilities. When a resident no longer
2825 meets the admission criteria for a facility licensed under this
2826 part, arrangements for relocating the person shall be made in
2827 accordance with s. 429.28(1)(k), unless the facility is licensed
2828 to provide extended congregate care services.
2829 (4) In accordance with s. 408.805, an applicant or licensee
2830 shall pay a fee for each license application submitted under
2831 this part, part II of chapter 408, and applicable rules. The
2832 amount of the fee shall be established by rule.
2833 (a) The biennial license fee required of a facility is $356
2834 $300 per license, with an additional fee of $67.50 $50 per
2835 resident based on the total licensed resident capacity of the
2836 facility, except that no additional fee will be assessed for
2837 beds designated for recipients of optional state supplementation
2838 payments provided for in s. 409.212. The total fee may not
2839 exceed $18,000 $10,000.
2840 (b) In addition to the total fee assessed under paragraph
2841 (a), the agency shall require facilities that are licensed to
2842 provide extended congregate care services under this part to pay
2843 an additional fee per licensed facility. The amount of the
2844 biennial fee shall be $501 $400 per license, with an additional
2845 fee of $10 per resident based on the total licensed resident
2846 capacity of the facility.
2847 (c) In addition to the total fee assessed under paragraph
2848 (a), the agency shall require facilities that are licensed to
2849 provide limited nursing services under this part to pay an
2850 additional fee per licensed facility. The amount of the biennial
2851 fee shall be $250 per license, with an additional fee of $10 per
2852 resident based on the total licensed resident capacity of the
2853 facility.
2854 (6) In order to determine whether the facility is
2855 adequately protecting residents’ rights as provided in s.
2856 429.28, the biennial survey shall include private informal
2857 conversations with a sample of residents and consultation with
2858 the ombudsman council in the planning and service area in which
2859 the facility is located to discuss residents’ experiences within
2860 the facility.
2861 (7) An assisted living facility that has been cited within
2862 the previous 24-month period for a class I or class II
2863 violation, regardless of the status of any enforcement or
2864 disciplinary action, is subject to periodic unannounced
2865 monitoring to determine if the facility is in compliance with
2866 this part, part II of chapter 408, and applicable rules.
2867 Monitoring may occur through a desk review or an onsite
2868 assessment. If the class I or class II violation relates to
2869 providing or failing to provide nursing care, a registered nurse
2870 must participate in at least two onsite monitoring visits within
2871 a 12-month period.
2872 Section 69. Subsection (7) of section 429.11, Florida
2873 Statutes, is renumbered as subsection (6), and present
2874 subsection (6) of that section is amended to read:
2875 429.11 Initial application for license; provisional
2876 license.—
2877 (6) In addition to the license categories available in s.
2878 408.808, a provisional license may be issued to an applicant
2879 making initial application for licensure or making application
2880 for a change of ownership. A provisional license shall be
2881 limited in duration to a specific period of time not to exceed 6
2882 months, as determined by the agency.
2883 Section 70. Section 429.12, Florida Statutes, is amended to
2884 read:
2885 429.12 Sale or transfer of ownership of a facility.—It is
2886 the intent of the Legislature to protect the rights of the
2887 residents of an assisted living facility when the facility is
2888 sold or the ownership thereof is transferred. Therefore, in
2889 addition to the requirements of part II of chapter 408, whenever
2890 a facility is sold or the ownership thereof is transferred,
2891 including leasing:.
2892 (1) The transferee shall notify the residents, in writing,
2893 of the change of ownership within 7 days after receipt of the
2894 new license.
2895 (2) The transferor of a facility the license of which is
2896 denied pending an administrative hearing shall, as a part of the
2897 written change-of-ownership contract, advise the transferee that
2898 a plan of correction must be submitted by the transferee and
2899 approved by the agency at least 7 days before the change of
2900 ownership and that failure to correct the condition which
2901 resulted in the moratorium pursuant to part II of chapter 408 or
2902 denial of licensure is grounds for denial of the transferee’s
2903 license.
2904 Section 71. Paragraphs (b) through (l) of subsection (1) of
2905 section 429.14, Florida Statutes, are redesignated as paragraphs
2906 (a) through (k), respectively, and present paragraph (a) of
2907 subsection (1) and subsections (5) and (6) of that section are
2908 amended to read:
2909 429.14 Administrative penalties.—
2910 (1) In addition to the requirements of part II of chapter
2911 408, the agency may deny, revoke, and suspend any license issued
2912 under this part and impose an administrative fine in the manner
2913 provided in chapter 120 against a licensee of an assisted living
2914 facility for a violation of any provision of this part, part II
2915 of chapter 408, or applicable rules, or for any of the following
2916 actions by a licensee of an assisted living facility, for the
2917 actions of any person subject to level 2 background screening
2918 under s. 408.809, or for the actions of any facility employee:
2919 (a) An intentional or negligent act seriously affecting the
2920 health, safety, or welfare of a resident of the facility.
2921 (5) An action taken by the agency to suspend, deny, or
2922 revoke a facility’s license under this part or part II of
2923 chapter 408, in which the agency claims that the facility owner
2924 or an employee of the facility has threatened the health,
2925 safety, or welfare of a resident of the facility shall be heard
2926 by the Division of Administrative Hearings of the Department of
2927 Management Services within 120 days after receipt of the
2928 facility’s request for a hearing, unless that time limitation is
2929 waived by both parties. The administrative law judge must render
2930 a decision within 30 days after receipt of a proposed
2931 recommended order.
2932 (6) The agency shall provide to the Division of Hotels and
2933 Restaurants of the Department of Business and Professional
2934 Regulation, on a monthly basis, a list of those assisted living
2935 facilities that have had their licenses denied, suspended, or
2936 revoked or that are involved in an appellate proceeding pursuant
2937 to s. 120.60 related to the denial, suspension, or revocation of
2938 a license. This information may be provided electronically or
2939 through the agency’s Internet website.
2940 Section 72. Subsections (1), (4), and (5) of section
2941 429.17, Florida Statutes, are amended to read:
2942 429.17 Expiration of license; renewal; conditional
2943 license.—
2944 (1) Limited nursing, Extended congregate care, and limited
2945 mental health licenses shall expire at the same time as the
2946 facility’s standard license, regardless of when issued.
2947 (4) In addition to the license categories available in s.
2948 408.808, a conditional license may be issued to an applicant for
2949 license renewal if the applicant fails to meet all standards and
2950 requirements for licensure. A conditional license issued under
2951 this subsection shall be limited in duration to a specific
2952 period of time not to exceed 6 months, as determined by the
2953 agency, and shall be accompanied by an agency-approved plan of
2954 correction.
2955 (5) When an extended congregate care or limited nursing
2956 license is requested during a facility’s biennial license
2957 period, the fee shall be prorated in order to permit the
2958 additional license to expire at the end of the biennial license
2959 period. The fee shall be calculated as of the date the
2960 additional license application is received by the agency.
2961 Section 73. Subsection (7) of section 429.19, Florida
2962 Statutes, is amended to read:
2963 429.19 Violations; imposition of administrative fines;
2964 grounds.—
2965 (7) In addition to any administrative fines imposed, the
2966 agency may assess a survey or monitoring fee, equal to the
2967 lesser of one half of the facility’s biennial license and bed
2968 fee or $500, to cover the cost of conducting initial complaint
2969 investigations that result in the finding of a violation that
2970 was the subject of the complaint or to monitor the health,
2971 safety, or security of residents under s. 429.07(7) monitoring
2972 visits conducted under s. 429.28(3)(c) to verify the correction
2973 of the violations.
2974 Section 74. Subsections (6) through (10) of section 429.23,
2975 Florida Statutes, are renumbered as subsections (5) through (9),
2976 respectively, and present subsection (5) of that section is
2977 amended to read:
2978 429.23 Internal risk management and quality assurance
2979 program; adverse incidents and reporting requirements.—
2980 (5) Each facility shall report monthly to the agency any
2981 liability claim filed against it. The report must include the
2982 name of the resident, the dates of the incident leading to the
2983 claim, if applicable, and the type of injury or violation of
2984 rights alleged to have occurred. This report is not discoverable
2985 in any civil or administrative action, except in such actions
2986 brought by the agency to enforce the provisions of this part.
2987 Section 75. Paragraph (a) of subsection (1) and subsection
2988 (2) of section 429.255, Florida Statutes, are amended to read:
2989 429.255 Use of personnel; emergency care.—
2990 (1)(a) Persons under contract to the facility or, facility
2991 staff, or volunteers, who are licensed according to part I of
2992 chapter 464, or those persons exempt under s. 464.022(1), and
2993 others as defined by rule, may administer medications to
2994 residents, take residents’ vital signs, manage individual weekly
2995 pill organizers for residents who self-administer medication,
2996 give prepackaged enemas ordered by a physician, observe
2997 residents, document observations on the appropriate resident’s
2998 record, report observations to the resident’s physician, and
2999 contract or allow residents or a resident’s representative,
3000 designee, surrogate, guardian, or attorney in fact to contract
3001 with a third party, provided residents meet the criteria for
3002 appropriate placement as defined in s. 429.26. Persons under
3003 contract to the facility or facility staff who are licensed
3004 according to part I of chapter 464 may provide limited nursing
3005 services. Nursing assistants certified pursuant to part II of
3006 chapter 464 may take residents’ vital signs as directed by a
3007 licensed nurse or physician. The facility is responsible for
3008 maintaining documentation of services provided under this
3009 paragraph as required by rule and ensuring that staff are
3010 adequately trained to monitor residents receiving these
3011 services.
3012 (2) In facilities licensed to provide extended congregate
3013 care, persons under contract to the facility or, facility staff,
3014 or volunteers, who are licensed according to part I of chapter
3015 464, or those persons exempt under s. 464.022(1), or those
3016 persons certified as nursing assistants pursuant to part II of
3017 chapter 464, may also perform all duties within the scope of
3018 their license or certification, as approved by the facility
3019 administrator and pursuant to this part.
3020 Section 76. Subsection (3) of section 429.28, Florida
3021 Statutes, is amended to read:
3022 429.28 Resident bill of rights.—
3023 (3)(a) The agency shall conduct a survey to determine
3024 general compliance with facility standards and compliance with
3025 residents’ rights as a prerequisite to initial licensure or
3026 licensure renewal.
3027 (b) In order to determine whether the facility is
3028 adequately protecting residents’ rights, the biennial survey
3029 shall include private informal conversations with a sample of
3030 residents and consultation with the ombudsman council in the
3031 planning and service area in which the facility is located to
3032 discuss residents’ experiences within the facility.
3033 (c) During any calendar year in which no survey is
3034 conducted, the agency shall conduct at least one monitoring
3035 visit of each facility cited in the previous year for a class I
3036 or class II violation, or more than three uncorrected class III
3037 violations.
3038 (d) The agency may conduct periodic followup inspections as
3039 necessary to monitor the compliance of facilities with a history
3040 of any class I, class II, or class III violations that threaten
3041 the health, safety, or security of residents.
3042 (e) The agency may conduct complaint investigations as
3043 warranted to investigate any allegations of noncompliance with
3044 requirements required under this part or rules adopted under
3045 this part.
3046 Section 77. Subsection (2) of section 429.35, Florida
3047 Statutes, is amended to read:
3048 429.35 Maintenance of records; reports.—
3049 (2) Within 60 days after the date of the biennial
3050 inspection visit required under s. 408.811 or within 30 days
3051 after the date of any interim visit, the agency shall forward
3052 the results of the inspection to the local ombudsman council in
3053 whose planning and service area, as defined in part II of
3054 chapter 400, the facility is located; to at least one public
3055 library or, in the absence of a public library, the county seat
3056 in the county in which the inspected assisted living facility is
3057 located; and, when appropriate, to the district Adult Services
3058 and Mental Health Program Offices. This information may be
3059 provided electronically or through the agency’s Internet
3060 website.
3061 Section 78. Paragraphs (i) and (j) of subsection (1) of
3062 section 429.41, Florida Statutes, are amended to read:
3063 429.41 Rules establishing standards.—
3064 (1) It is the intent of the Legislature that rules
3065 published and enforced pursuant to this section shall include
3066 criteria by which a reasonable and consistent quality of
3067 resident care and quality of life may be ensured and the results
3068 of such resident care may be demonstrated. Such rules shall also
3069 ensure a safe and sanitary environment that is residential and
3070 noninstitutional in design or nature. It is further intended
3071 that reasonable efforts be made to accommodate the needs and
3072 preferences of residents to enhance the quality of life in a
3073 facility. The agency, in consultation with the department, may
3074 adopt rules to administer the requirements of part II of chapter
3075 408. In order to provide safe and sanitary facilities and the
3076 highest quality of resident care accommodating the needs and
3077 preferences of residents, the department, in consultation with
3078 the agency, the Department of Children and Family Services, and
3079 the Department of Health, shall adopt rules, policies, and
3080 procedures to administer this part, which must include
3081 reasonable and fair minimum standards in relation to:
3082 (i) Facilities holding an a limited nursing, extended
3083 congregate care, or limited mental health license.
3084 (j) The establishment of specific criteria to define
3085 appropriateness of resident admission and continued residency in
3086 a facility holding a standard, limited nursing, extended
3087 congregate care, and limited mental health license.
3088 Section 79. Subsections (1) and (2) of section 429.53,
3089 Florida Statutes, are amended to read:
3090 429.53 Consultation by the agency.—
3091 (1) The area offices of licensure and certification of the
3092 agency shall provide consultation to the following upon request:
3093 (a) A licensee of a facility.
3094 (b) A person interested in obtaining a license to operate a
3095 facility under this part.
3096 (2) As used in this section, “consultation” includes:
3097 (a) An explanation of the requirements of this part and
3098 rules adopted pursuant thereto;
3099 (b) An explanation of the license application and renewal
3100 procedures;
3101 (c) The provision of a checklist of general local and state
3102 approvals required prior to constructing or developing a
3103 facility and a listing of the types of agencies responsible for
3104 such approvals;
3105 (d) An explanation of benefits and financial assistance
3106 available to a recipient of supplemental security income
3107 residing in a facility;
3108 (c)(e) Any other information which the agency deems
3109 necessary to promote compliance with the requirements of this
3110 part; and
3111 (f) A preconstruction review of a facility to ensure
3112 compliance with agency rules and this part.
3113 Section 80. Subsections (1) and (2) of section 429.54,
3114 Florida Statutes, are renumbered as subsections (2) and (3),
3115 respectively, and a new subsection (1) is added to that section
3116 to read:
3117 429.54 Collection of information; local subsidy.—
3118 (1) A facility that is licensed under this part must report
3119 electronically to the agency semiannually data related to the
3120 facility, including, but not limited to, the total number of
3121 residents, the number of residents who are receiving limited
3122 mental health services, the number of residents who are
3123 receiving extended congregate care services, the number of
3124 residents who are receiving limited nursing services, and
3125 professional staffing employed by or under contract with the
3126 licensee to provide resident services. The department, in
3127 consultation with the agency, shall adopt rules to administer
3128 this subsection.
3129 Section 81. Subsections (1) and (5) of section 429.71,
3130 Florida Statutes, are amended to read:
3131 429.71 Classification of violations deficiencies;
3132 administrative fines.—
3133 (1) In addition to the requirements of part II of chapter
3134 408 and in addition to any other liability or penalty provided
3135 by law, the agency may impose an administrative fine on a
3136 provider according to the following classification:
3137 (a) Class I violations are defined in s. 408.813 those
3138 conditions or practices related to the operation and maintenance
3139 of an adult family-care home or to the care of residents which
3140 the agency determines present an imminent danger to the
3141 residents or guests of the facility or a substantial probability
3142 that death or serious physical or emotional harm would result
3143 therefrom. The condition or practice that constitutes a class I
3144 violation must be abated or eliminated within 24 hours, unless a
3145 fixed period, as determined by the agency, is required for
3146 correction. A class I violation deficiency is subject to an
3147 administrative fine in an amount not less than $500 and not
3148 exceeding $1,000 for each violation. A fine may be levied
3149 notwithstanding the correction of the deficiency.
3150 (b) Class II violations are defined in s. 408.813 those
3151 conditions or practices related to the operation and maintenance
3152 of an adult family-care home or to the care of residents which
3153 the agency determines directly threaten the physical or
3154 emotional health, safety, or security of the residents, other
3155 than class I violations. A class II violation is subject to an
3156 administrative fine in an amount not less than $250 and not
3157 exceeding $500 for each violation. A citation for a class II
3158 violation must specify the time within which the violation is
3159 required to be corrected. If a class II violation is corrected
3160 within the time specified, no civil penalty shall be imposed,
3161 unless it is a repeated offense.
3162 (c) Class III violations are defined in s. 408.813 those
3163 conditions or practices related to the operation and maintenance
3164 of an adult family-care home or to the care of residents which
3165 the agency determines indirectly or potentially threaten the
3166 physical or emotional health, safety, or security of residents,
3167 other than class I or class II violations. A class III violation
3168 is subject to an administrative fine in an amount not less than
3169 $100 and not exceeding $250 for each violation. A citation for a
3170 class III violation shall specify the time within which the
3171 violation is required to be corrected. If a class III violation
3172 is corrected within the time specified, no civil penalty shall
3173 be imposed, unless it is a repeated violation offense.
3174 (d) Class IV violations are defined in s. 408.813 those
3175 conditions or occurrences related to the operation and
3176 maintenance of an adult family-care home, or related to the
3177 required reports, forms, or documents, which do not have the
3178 potential of negatively affecting the residents. A provider that
3179 does not correct A class IV violation within the time limit
3180 specified by the agency is subject to an administrative fine in
3181 an amount not less than $50 and not exceeding $100 for each
3182 violation. Any class IV violation that is corrected during the
3183 time the agency survey is conducted will be identified as an
3184 agency finding and not as a violation, unless it is a repeat
3185 violation.
3186 (5) As an alternative to or in conjunction with an
3187 administrative action against a provider, the agency may request
3188 a plan of corrective action that demonstrates a good faith
3189 effort to remedy each violation by a specific date, subject to
3190 the approval of the agency.
3191 Section 82. Paragraphs (b) through (e) of subsection (2) of
3192 section 429.911, Florida Statutes, are redesignated as
3193 paragraphs (a) through (d), respectively, and present paragraph
3194 (a) of that subsection is amended to read:
3195 429.911 Denial, suspension, revocation of license;
3196 emergency action; administrative fines; investigations and
3197 inspections.—
3198 (2) Each of the following actions by the owner of an adult
3199 day care center or by its operator or employee is a ground for
3200 action by the agency against the owner of the center or its
3201 operator or employee:
3202 (a) An intentional or negligent act materially affecting
3203 the health or safety of center participants.
3204 Section 83. Section 429.915, Florida Statutes, is amended
3205 to read:
3206 429.915 Conditional license.—In addition to the license
3207 categories available in part II of chapter 408, the agency may
3208 issue a conditional license to an applicant for license renewal
3209 or change of ownership if the applicant fails to meet all
3210 standards and requirements for licensure. A conditional license
3211 issued under this subsection must be limited to a specific
3212 period not exceeding 6 months, as determined by the agency, and
3213 must be accompanied by an approved plan of correction.
3214 Section 84. Paragraphs (b) and (h) of subsection (3) of
3215 section 430.80, Florida Statutes, are amended to read:
3216 430.80 Implementation of a teaching nursing home pilot
3217 project.—
3218 (3) To be designated as a teaching nursing home, a nursing
3219 home licensee must, at a minimum:
3220 (b) Participate in a nationally recognized accreditation
3221 program and hold a valid accreditation, such as the
3222 accreditation awarded by The Joint Commission on Accreditation
3223 of Healthcare Organizations;
3224 (h) Maintain insurance coverage pursuant to s.
3225 400.141(1)(q)(s) or proof of financial responsibility in a
3226 minimum amount of $750,000. Such proof of financial
3227 responsibility may include:
3228 1. Maintaining an escrow account consisting of cash or
3229 assets eligible for deposit in accordance with s. 625.52; or
3230 2. Obtaining and maintaining pursuant to chapter 675 an
3231 unexpired, irrevocable, nontransferable and nonassignable letter
3232 of credit issued by any bank or savings association organized
3233 and existing under the laws of this state or any bank or savings
3234 association organized under the laws of the United States that
3235 has its principal place of business in this state or has a
3236 branch office which is authorized to receive deposits in this
3237 state. The letter of credit shall be used to satisfy the
3238 obligation of the facility to the claimant upon presentment of a
3239 final judgment indicating liability and awarding damages to be
3240 paid by the facility or upon presentment of a settlement
3241 agreement signed by all parties to the agreement when such final
3242 judgment or settlement is a result of a liability claim against
3243 the facility.
3244 Section 85. Paragraph (a) of subsection (2) of section
3245 440.13, Florida Statutes, is amended to read:
3246 440.13 Medical services and supplies; penalty for
3247 violations; limitations.—
3248 (2) MEDICAL TREATMENT; DUTY OF EMPLOYER TO FURNISH.—
3249 (a) Subject to the limitations specified elsewhere in this
3250 chapter, the employer shall furnish to the employee such
3251 medically necessary remedial treatment, care, and attendance for
3252 such period as the nature of the injury or the process of
3253 recovery may require, which is in accordance with established
3254 practice parameters and protocols of treatment as provided for
3255 in this chapter, including medicines, medical supplies, durable
3256 medical equipment, orthoses, prostheses, and other medically
3257 necessary apparatus. Remedial treatment, care, and attendance,
3258 including work-hardening programs or pain-management programs
3259 accredited by the Commission on Accreditation of Rehabilitation
3260 Facilities or The Joint Commission on the Accreditation of
3261 Health Organizations or pain-management programs affiliated with
3262 medical schools, shall be considered as covered treatment only
3263 when such care is given based on a referral by a physician as
3264 defined in this chapter. Medically necessary treatment, care,
3265 and attendance does not include chiropractic services in excess
3266 of 24 treatments or rendered 12 weeks beyond the date of the
3267 initial chiropractic treatment, whichever comes first, unless
3268 the carrier authorizes additional treatment or the employee is
3269 catastrophically injured.
3270
3271 Failure of the carrier to timely comply with this subsection
3272 shall be a violation of this chapter and the carrier shall be
3273 subject to penalties as provided for in s. 440.525.
3274 Section 86. Subsection (11) is added to section 483.201,
3275 Florida Statutes, to read:
3276 483.201 Grounds for disciplinary action against clinical
3277 laboratories.—In addition to the requirements of part II of
3278 chapter 408, the following acts constitute grounds for which a
3279 disciplinary action specified in s. 483.221 may be taken against
3280 a clinical laboratory:
3281 (11) A blood establishment that collects blood or blood
3282 components from volunteer donors failing to disclose information
3283 concerning its activities as required by s. 381.06014. Each day
3284 of violation constitutes a separate violation and each separate
3285 violation is subject to a separate fine. If multiple licensed
3286 establishments operated by a single business entity fail to meet
3287 such disclosure requirements, the agency may assess fines
3288 against only one of the business entity’s clinical laboratory
3289 licenses. The total administrative fine may not exceed $10,000
3290 for each annual reporting period.
3291 Section 87. Section 483.294, Florida Statutes, is amended
3292 to read:
3293 483.294 Inspection of centers.—In accordance with s.
3294 408.811, the agency shall biennially, at least once annually,
3295 inspect the premises and operations of all centers subject to
3296 licensure under this part.
3297 Section 88. Subsection (23) and paragraph (a) of subsection
3298 (53) of section 499.003, Florida Statutes, are amended to read:
3299 499.003 Definitions of terms used in this part.—As used in
3300 this part, the term:
3301 (23) “Health care entity” means a closed pharmacy or any
3302 person, organization, or business entity that provides
3303 diagnostic, medical, surgical, or dental treatment or care, or
3304 chronic or rehabilitative care, but does not include any
3305 wholesale distributor or retail pharmacy licensed under state
3306 law to deal in prescription drugs. However, a blood
3307 establishment may be a health care entity and engage in the
3308 wholesale distribution of prescription drugs under s.
3309 499.01(2)(g)1.c.
3310 (53) “Wholesale distribution” means distribution of
3311 prescription drugs to persons other than a consumer or patient,
3312 but does not include:
3313 (a) Any of the following activities, which is not a
3314 violation of s. 499.005(21) if such activity is conducted in
3315 accordance with s. 499.01(2)(g):
3316 1. The purchase or other acquisition by a hospital or other
3317 health care entity that is a member of a group purchasing
3318 organization of a prescription drug for its own use from the
3319 group purchasing organization or from other hospitals or health
3320 care entities that are members of that organization.
3321 2. The sale, purchase, or trade of a prescription drug or
3322 an offer to sell, purchase, or trade a prescription drug by a
3323 charitable organization described in s. 501(c)(3) of the
3324 Internal Revenue Code of 1986, as amended and revised, to a
3325 nonprofit affiliate of the organization to the extent otherwise
3326 permitted by law.
3327 3. The sale, purchase, or trade of a prescription drug or
3328 an offer to sell, purchase, or trade a prescription drug among
3329 hospitals or other health care entities that are under common
3330 control. For purposes of this subparagraph, “common control”
3331 means the power to direct or cause the direction of the
3332 management and policies of a person or an organization, whether
3333 by ownership of stock, by voting rights, by contract, or
3334 otherwise.
3335 4. The sale, purchase, trade, or other transfer of a
3336 prescription drug from or for any federal, state, or local
3337 government agency or any entity eligible to purchase
3338 prescription drugs at public health services prices pursuant to
3339 Pub. L. No. 102-585, s. 602 to a contract provider or its
3340 subcontractor for eligible patients of the agency or entity
3341 under the following conditions:
3342 a. The agency or entity must obtain written authorization
3343 for the sale, purchase, trade, or other transfer of a
3344 prescription drug under this subparagraph from the State Surgeon
3345 General or his or her designee.
3346 b. The contract provider or subcontractor must be
3347 authorized by law to administer or dispense prescription drugs.
3348 c. In the case of a subcontractor, the agency or entity
3349 must be a party to and execute the subcontract.
3350 d. A contract provider or subcontractor must maintain
3351 separate and apart from other prescription drug inventory any
3352 prescription drugs of the agency or entity in its possession.
3353 d.e. The contract provider and subcontractor must maintain
3354 and produce immediately for inspection all records of movement
3355 or transfer of all the prescription drugs belonging to the
3356 agency or entity, including, but not limited to, the records of
3357 receipt and disposition of prescription drugs. Each contractor
3358 and subcontractor dispensing or administering these drugs must
3359 maintain and produce records documenting the dispensing or
3360 administration. Records that are required to be maintained
3361 include, but are not limited to, a perpetual inventory itemizing
3362 drugs received and drugs dispensed by prescription number or
3363 administered by patient identifier, which must be submitted to
3364 the agency or entity quarterly.
3365 e.f. The contract provider or subcontractor may administer
3366 or dispense the prescription drugs only to the eligible patients
3367 of the agency or entity or must return the prescription drugs
3368 for or to the agency or entity. The contract provider or
3369 subcontractor must require proof from each person seeking to
3370 fill a prescription or obtain treatment that the person is an
3371 eligible patient of the agency or entity and must, at a minimum,
3372 maintain a copy of this proof as part of the records of the
3373 contractor or subcontractor required under sub-subparagraph d.
3374 e.
3375 f.g. In addition to the departmental inspection authority
3376 set forth in s. 499.051, the establishment of the contract
3377 provider and subcontractor and all records pertaining to
3378 prescription drugs subject to this subparagraph shall be subject
3379 to inspection by the agency or entity. All records relating to
3380 prescription drugs of a manufacturer under this subparagraph
3381 shall be subject to audit by the manufacturer of those drugs,
3382 without identifying individual patient information.
3383 Section 89. Subsection (21) of section 499.005, Florida
3384 Statutes, is amended to read:
3385 499.005 Prohibited acts.—It is unlawful for a person to
3386 perform or cause the performance of any of the following acts in
3387 this state:
3388 (21) The wholesale distribution of any prescription drug
3389 that was:
3390 (a) Purchased by a public or private hospital or other
3391 health care entity, except as authorized in s. 499.01(2)(g)1.c.;
3392 or
3393 (b) Donated or supplied at a reduced price to a charitable
3394 organization.
3395 Section 90. Paragraphs (a) and (g) of subsection (2) of
3396 section 499.01, Florida Statutes, are amended to read:
3397 499.01 Permits.—
3398 (2) The following permits are established:
3399 (a) Prescription drug manufacturer permit.—A prescription
3400 drug manufacturer permit is required for any person that is a
3401 manufacturer of a prescription drug and that manufactures or
3402 distributes such prescription drugs in this state.
3403 1. A person that operates an establishment permitted as a
3404 prescription drug manufacturer may engage in wholesale
3405 distribution of prescription drugs manufactured at that
3406 establishment and must comply with all of the provisions of this
3407 part, except s. 499.01212, and the rules adopted under this
3408 part, except s. 499.01212, that apply to a wholesale
3409 distributor.
3410 2. A prescription drug manufacturer must comply with all
3411 appropriate state and federal good manufacturing practices.
3412 3. A blood establishment as defined in s. 381.06014,
3413 operating in a manner consistent with the provisions of Title 21
3414 C.F.R. Parts 211 and 600-640, and manufacturing only the
3415 prescription drugs described in s. 499.003(53)(d) is not
3416 required to be permitted as a prescription drug manufacturer
3417 under this paragraph or register products under s. 499.015.
3418 (g) Restricted prescription drug distributor permit.—
3419 1. A restricted prescription drug distributor permit is
3420 required for:
3421 a. Any person that engages in the distribution of a
3422 prescription drug, which distribution is not considered
3423 “wholesale distribution” under s. 499.003(53)(a).
3424 b.1. Any A person who engages in the receipt or
3425 distribution of a prescription drug in this state for the
3426 purpose of processing its return or its destruction must obtain
3427 a permit as a restricted prescription drug distributor if such
3428 person is not the person initiating the return, the prescription
3429 drug wholesale supplier of the person initiating the return, or
3430 the manufacturer of the drug.
3431 c. A blood establishment located in this state that
3432 collects blood and blood components only from volunteer donors
3433 as defined in s. 381.06014 or pursuant to an authorized
3434 practitioner’s order for medical treatment or therapy and
3435 engages in the wholesale distribution of a prescription drug not
3436 described in s. 499.003(53)(d) to a health care entity. The
3437 health care entity receiving a prescription drug distributed
3438 under this sub-subparagraph must be licensed as a closed
3439 pharmacy or provide health care services at that establishment.
3440 The blood establishment must operate in accordance with s.
3441 381.06014 and may distribute only:
3442 (I) Prescription drugs indicated for a bleeding or clotting
3443 disorder or anemia;
3444 (II) Blood-collection containers approved under s. 505 of
3445 the federal act;
3446 (III) Drugs that are blood derivatives, or a recombinant or
3447 synthetic form of a blood derivative; or
3448 (IV) Prescription drugs identified in rules adopted by the
3449 department which are essential to services performed or provided
3450 by blood establishments and authorized for distribution by blood
3451 establishments under federal law,
3452
3453 as long as all of the health care services provided by the blood
3454 establishment are related to its activities as a registered
3455 blood establishment or the health care services consist of
3456 collecting, processing, storing, or administering human
3457 hematopoietic stem cells or progenitor cells or performing
3458 diagnostic testing of specimens if such specimens are tested
3459 together with specimens undergoing routine donor testing.
3460 2. Storage, handling, and recordkeeping of these
3461 distributions by a person permitted as a restricted prescription
3462 drug distributor must comply with the requirements for wholesale
3463 distributors under s. 499.0121, but not those set forth in s.
3464 499.01212 if the distribution occurs pursuant to sub
3465 subparagraph 1.a. or sub-subparagraph 1.b.
3466 3. A person who applies for a permit as a restricted
3467 prescription drug distributor, or for the renewal of such a
3468 permit, must provide to the department the information required
3469 under s. 499.012.
3470 4. The department may adopt rules regarding the
3471 distribution of prescription drugs by hospitals, health care
3472 entities, charitable organizations, or other persons not
3473 involved in wholesale distribution, and blood establishments;
3474 which rules are necessary for the protection of the public
3475 health, safety, and welfare. The department may adopt rules
3476 related to the transportation, storage, and recordkeeping of
3477 prescription drugs which are essential to services performed or
3478 provided by a blood establishment, including requirements for
3479 the use of prescription drugs in mobile blood-collection
3480 vehicles.
3481 Section 91. Paragraph (i) is added to subsection (3) of
3482 section 499.01212, Florida Statutes, to read:
3483 499.01212 Pedigree paper.—
3484 (3) EXCEPTIONS.—A pedigree paper is not required for:
3485 (i) The wholesale distribution of prescription drugs
3486 contained within a sealed medical convenience kit if the kit:
3487 1. Is assembled in an establishment that is registered as a
3488 medical device manufacturer with the Food and Drug
3489 Administration; and
3490 2. Does not contain any controlled substance that appears
3491 in any schedule contained in or subject to chapter 893 or the
3492 federal Comprehensive Drug Abuse Prevention and Control Act of
3493 1970.
3494 Section 92. Subsection (1) of section 627.645, Florida
3495 Statutes, is amended to read:
3496 627.645 Denial of health insurance claims restricted.—
3497 (1) No claim for payment under a health insurance policy or
3498 self-insured program of health benefits for treatment, care, or
3499 services in a licensed hospital which is accredited by The Joint
3500 Commission on the Accreditation of Hospitals, the American
3501 Osteopathic Association, or the Commission on the Accreditation
3502 of Rehabilitative Facilities shall be denied because such
3503 hospital lacks major surgical facilities and is primarily of a
3504 rehabilitative nature, if such rehabilitation is specifically
3505 for treatment of physical disability.
3506 Section 93. Paragraph (c) of subsection (2) of section
3507 627.668, Florida Statutes, is amended to read:
3508 627.668 Optional coverage for mental and nervous disorders
3509 required; exception.—
3510 (2) Under group policies or contracts, inpatient hospital
3511 benefits, partial hospitalization benefits, and outpatient
3512 benefits consisting of durational limits, dollar amounts,
3513 deductibles, and coinsurance factors shall not be less favorable
3514 than for physical illness generally, except that:
3515 (c) Partial hospitalization benefits shall be provided
3516 under the direction of a licensed physician. For purposes of
3517 this part, the term “partial hospitalization services” is
3518 defined as those services offered by a program accredited by The
3519 Joint Commission on Accreditation of Hospitals (JCAH) or in
3520 compliance with equivalent standards. Alcohol rehabilitation
3521 programs accredited by The Joint Commission on Accreditation of
3522 Hospitals or approved by the state and licensed drug abuse
3523 rehabilitation programs shall also be qualified providers under
3524 this section. In any benefit year, if partial hospitalization
3525 services or a combination of inpatient and partial
3526 hospitalization are utilized, the total benefits paid for all
3527 such services shall not exceed the cost of 30 days of inpatient
3528 hospitalization for psychiatric services, including physician
3529 fees, which prevail in the community in which the partial
3530 hospitalization services are rendered. If partial
3531 hospitalization services benefits are provided beyond the limits
3532 set forth in this paragraph, the durational limits, dollar
3533 amounts, and coinsurance factors thereof need not be the same as
3534 those applicable to physical illness generally.
3535 Section 94. Subsection (3) of section 627.669, Florida
3536 Statutes, is amended to read:
3537 627.669 Optional coverage required for substance abuse
3538 impaired persons; exception.—
3539 (3) The benefits provided under this section shall be
3540 applicable only if treatment is provided by, or under the
3541 supervision of, or is prescribed by, a licensed physician or
3542 licensed psychologist and if services are provided in a program
3543 accredited by The Joint Commission on Accreditation of Hospitals
3544 or approved by the state.
3545 Section 95. Paragraph (a) of subsection (1) of section
3546 627.736, Florida Statutes, is amended to read:
3547 627.736 Required personal injury protection benefits;
3548 exclusions; priority; claims.—
3549 (1) REQUIRED BENEFITS.—Every insurance policy complying
3550 with the security requirements of s. 627.733 shall provide
3551 personal injury protection to the named insured, relatives
3552 residing in the same household, persons operating the insured
3553 motor vehicle, passengers in such motor vehicle, and other
3554 persons struck by such motor vehicle and suffering bodily injury
3555 while not an occupant of a self-propelled vehicle, subject to
3556 the provisions of subsection (2) and paragraph (4)(e), to a
3557 limit of $10,000 for loss sustained by any such person as a
3558 result of bodily injury, sickness, disease, or death arising out
3559 of the ownership, maintenance, or use of a motor vehicle as
3560 follows:
3561 (a) Medical benefits.—Eighty percent of all reasonable
3562 expenses for medically necessary medical, surgical, X-ray,
3563 dental, and rehabilitative services, including prosthetic
3564 devices, and medically necessary ambulance, hospital, and
3565 nursing services. However, the medical benefits shall provide
3566 reimbursement only for such services and care that are lawfully
3567 provided, supervised, ordered, or prescribed by a physician
3568 licensed under chapter 458 or chapter 459, a dentist licensed
3569 under chapter 466, or a chiropractic physician licensed under
3570 chapter 460 or that are provided by any of the following persons
3571 or entities:
3572 1. A hospital or ambulatory surgical center licensed under
3573 chapter 395.
3574 2. A person or entity licensed under ss. 401.2101-401.45
3575 that provides emergency transportation and treatment.
3576 3. An entity wholly owned by one or more physicians
3577 licensed under chapter 458 or chapter 459, chiropractic
3578 physicians licensed under chapter 460, or dentists licensed
3579 under chapter 466 or by such practitioner or practitioners and
3580 the spouse, parent, child, or sibling of that practitioner or
3581 those practitioners.
3582 4. An entity wholly owned, directly or indirectly, by a
3583 hospital or hospitals.
3584 5. A health care clinic licensed under ss. 400.990-400.995
3585 that is:
3586 a. Accredited by The Joint Commission on Accreditation of
3587 Healthcare Organizations, the American Osteopathic Association,
3588 the Commission on Accreditation of Rehabilitation Facilities, or
3589 the Accreditation Association for Ambulatory Health Care, Inc.;
3590 or
3591 b. A health care clinic that:
3592 (I) Has a medical director licensed under chapter 458,
3593 chapter 459, or chapter 460;
3594 (II) Has been continuously licensed for more than 3 years
3595 or is a publicly traded corporation that issues securities
3596 traded on an exchange registered with the United States
3597 Securities and Exchange Commission as a national securities
3598 exchange; and
3599 (III) Provides at least four of the following medical
3600 specialties:
3601 (A) General medicine.
3602 (B) Radiography.
3603 (C) Orthopedic medicine.
3604 (D) Physical medicine.
3605 (E) Physical therapy.
3606 (F) Physical rehabilitation.
3607 (G) Prescribing or dispensing outpatient prescription
3608 medication.
3609 (H) Laboratory services.
3610
3611 The Financial Services Commission shall adopt by rule the form
3612 that must be used by an insurer and a health care provider
3613 specified in subparagraph 3., subparagraph 4., or subparagraph
3614 5. to document that the health care provider meets the criteria
3615 of this paragraph, which rule must include a requirement for a
3616 sworn statement or affidavit.
3617
3618 Only insurers writing motor vehicle liability insurance in this
3619 state may provide the required benefits of this section, and no
3620 such insurer shall require the purchase of any other motor
3621 vehicle coverage other than the purchase of property damage
3622 liability coverage as required by s. 627.7275 as a condition for
3623 providing such required benefits. Insurers may not require that
3624 property damage liability insurance in an amount greater than
3625 $10,000 be purchased in conjunction with personal injury
3626 protection. Such insurers shall make benefits and required
3627 property damage liability insurance coverage available through
3628 normal marketing channels. Any insurer writing motor vehicle
3629 liability insurance in this state who fails to comply with such
3630 availability requirement as a general business practice shall be
3631 deemed to have violated part IX of chapter 626, and such
3632 violation shall constitute an unfair method of competition or an
3633 unfair or deceptive act or practice involving the business of
3634 insurance; and any such insurer committing such violation shall
3635 be subject to the penalties afforded in such part, as well as
3636 those which may be afforded elsewhere in the insurance code.
3637 Section 96. Section 633.081, Florida Statutes, is amended
3638 to read:
3639 633.081 Inspection of buildings and equipment; orders;
3640 firesafety inspection training requirements; certification;
3641 disciplinary action.—The State Fire Marshal and her or his
3642 agents shall, at any reasonable hour, when the department has
3643 reasonable cause to believe that a violation of this chapter or
3644 s. 509.215, or a rule promulgated thereunder, or a minimum
3645 firesafety code adopted by a local authority, may exist, inspect
3646 any and all buildings and structures which are subject to the
3647 requirements of this chapter or s. 509.215 and rules promulgated
3648 thereunder. The authority to inspect shall extend to all
3649 equipment, vehicles, and chemicals which are located within the
3650 premises of any such building or structure. The State Fire
3651 Marshal and her or his agents shall inspect nursing homes
3652 licensed under part II of chapter 400 only once every calendar
3653 year and upon receiving a complaint forming the basis of a
3654 reasonable cause to believe that a violation of this chapter or
3655 s. 509.215, or a rule promulgated thereunder, or a minimum
3656 firesafety code adopted by a local authority may exist and upon
3657 identifying such a violation in the course of conducting
3658 orientation or training activities within a nursing home.
3659 (1) Each county, municipality, and special district that
3660 has firesafety enforcement responsibilities shall employ or
3661 contract with a firesafety inspector. The firesafety inspector
3662 must conduct all firesafety inspections that are required by
3663 law. The governing body of a county, municipality, or special
3664 district that has firesafety enforcement responsibilities may
3665 provide a schedule of fees to pay only the costs of inspections
3666 conducted pursuant to this subsection and related administrative
3667 expenses. Two or more counties, municipalities, or special
3668 districts that have firesafety enforcement responsibilities may
3669 jointly employ or contract with a firesafety inspector.
3670 (2) Every firesafety inspection conducted pursuant to state
3671 or local firesafety requirements shall be by a person certified
3672 as having met the inspection training requirements set by the
3673 State Fire Marshal. Such person shall:
3674 (a) Be a high school graduate or the equivalent as
3675 determined by the department;
3676 (b) Not have been found guilty of, or having pleaded guilty
3677 or nolo contendere to, a felony or a crime punishable by
3678 imprisonment of 1 year or more under the law of the United
3679 States, or of any state thereof, which involves moral turpitude,
3680 without regard to whether a judgment of conviction has been
3681 entered by the court having jurisdiction of such cases;
3682 (c) Have her or his fingerprints on file with the
3683 department or with an agency designated by the department;
3684 (d) Have good moral character as determined by the
3685 department;
3686 (e) Be at least 18 years of age;
3687 (f) Have satisfactorily completed the firesafety inspector
3688 certification examination as prescribed by the department; and
3689 (g)1. Have satisfactorily completed, as determined by the
3690 department, a firesafety inspector training program of not less
3691 than 200 hours established by the department and administered by
3692 agencies and institutions approved by the department for the
3693 purpose of providing basic certification training for firesafety
3694 inspectors; or
3695 2. Have received in another state training which is
3696 determined by the department to be at least equivalent to that
3697 required by the department for approved firesafety inspector
3698 education and training programs in this state.
3699 (3) Each special state firesafety inspection which is
3700 required by law and is conducted by or on behalf of an agency of
3701 the state must be performed by an individual who has met the
3702 provision of subsection (2), except that the duration of the
3703 training program shall not exceed 120 hours of specific training
3704 for the type of property that such special state firesafety
3705 inspectors are assigned to inspect.
3706 (4) A firefighter certified pursuant to s. 633.35 may
3707 conduct firesafety inspections, under the supervision of a
3708 certified firesafety inspector, while on duty as a member of a
3709 fire department company conducting inservice firesafety
3710 inspections without being certified as a firesafety inspector,
3711 if such firefighter has satisfactorily completed an inservice
3712 fire department company inspector training program of at least
3713 24 hours’ duration as provided by rule of the department.
3714 (5) Every firesafety inspector or special state firesafety
3715 inspector certificate is valid for a period of 3 years from the
3716 date of issuance. Renewal of certification shall be subject to
3717 the affected person’s completing proper application for renewal
3718 and meeting all of the requirements for renewal as established
3719 under this chapter or by rule promulgated thereunder, which
3720 shall include completion of at least 40 hours during the
3721 preceding 3-year period of continuing education as required by
3722 the rule of the department or, in lieu thereof, successful
3723 passage of an examination as established by the department.
3724 (6) The State Fire Marshal may deny, refuse to renew,
3725 suspend, or revoke the certificate of a firesafety inspector or
3726 special state firesafety inspector if it finds that any of the
3727 following grounds exist:
3728 (a) Any cause for which issuance of a certificate could
3729 have been refused had it then existed and been known to the
3730 State Fire Marshal.
3731 (b) Violation of this chapter or any rule or order of the
3732 State Fire Marshal.
3733 (c) Falsification of records relating to the certificate.
3734 (d) Having been found guilty of or having pleaded guilty or
3735 nolo contendere to a felony, whether or not a judgment of
3736 conviction has been entered.
3737 (e) Failure to meet any of the renewal requirements.
3738 (f) Having been convicted of a crime in any jurisdiction
3739 which directly relates to the practice of fire code inspection,
3740 plan review, or administration.
3741 (g) Making or filing a report or record that the
3742 certificateholder knows to be false, or knowingly inducing
3743 another to file a false report or record, or knowingly failing
3744 to file a report or record required by state or local law, or
3745 knowingly impeding or obstructing such filing, or knowingly
3746 inducing another person to impede or obstruct such filing.
3747 (h) Failing to properly enforce applicable fire codes or
3748 permit requirements within this state which the
3749 certificateholder knows are applicable by committing willful
3750 misconduct, gross negligence, gross misconduct, repeated
3751 negligence, or negligence resulting in a significant danger to
3752 life or property.
3753 (i) Accepting labor, services, or materials at no charge or
3754 at a noncompetitive rate from any person who performs work that
3755 is under the enforcement authority of the certificateholder and
3756 who is not an immediate family member of the certificateholder.
3757 For the purpose of this paragraph, the term “immediate family
3758 member” means a spouse, child, parent, sibling, grandparent,
3759 aunt, uncle, or first cousin of the person or the person’s
3760 spouse or any person who resides in the primary residence of the
3761 certificateholder.
3762 (7) The department shall provide by rule for the
3763 certification of firesafety inspectors.
3764 Section 97. Subsection (12) of section 641.495, Florida
3765 Statutes, is amended to read:
3766 641.495 Requirements for issuance and maintenance of
3767 certificate.—
3768 (12) The provisions of part I of chapter 395 do not apply
3769 to a health maintenance organization that, on or before January
3770 1, 1991, provides not more than 10 outpatient holding beds for
3771 short-term and hospice-type patients in an ambulatory care
3772 facility for its members, provided that such health maintenance
3773 organization maintains current accreditation by The Joint
3774 Commission on Accreditation of Health Care Organizations, the
3775 Accreditation Association for Ambulatory Health Care, or the
3776 National Committee for Quality Assurance.
3777 Section 98. Subsection (13) of section 651.118, Florida
3778 Statutes, is amended to read:
3779 651.118 Agency for Health Care Administration; certificates
3780 of need; sheltered beds; community beds.—
3781 (13) Residents, as defined in this chapter, are not
3782 considered new admissions for the purpose of s.
3783 400.141(1)(n)(o)1.d.
3784 Section 99. Subsection (2) of section 766.1015, Florida
3785 Statutes, is amended to read:
3786 766.1015 Civil immunity for members of or consultants to
3787 certain boards, committees, or other entities.—
3788 (2) Such committee, board, group, commission, or other
3789 entity must be established in accordance with state law or in
3790 accordance with requirements of The Joint Commission on
3791 Accreditation of Healthcare Organizations, established and duly
3792 constituted by one or more public or licensed private hospitals
3793 or behavioral health agencies, or established by a governmental
3794 agency. To be protected by this section, the act, decision,
3795 omission, or utterance may not be made or done in bad faith or
3796 with malicious intent.
3797 Section 100. Subsection (4) of section 766.202, Florida
3798 Statutes, is amended to read:
3799 766.202 Definitions; ss. 766.201-766.212.—As used in ss.
3800 766.201-766.212, the term:
3801 (4) “Health care provider” means any hospital, ambulatory
3802 surgical center, or mobile surgical facility as defined and
3803 licensed under chapter 395; a birth center licensed under
3804 chapter 383; any person licensed under chapter 458, chapter 459,
3805 chapter 460, chapter 461, chapter 462, chapter 463, part I of
3806 chapter 464, chapter 466, chapter 467, part XIV of chapter 468,
3807 or chapter 486; a clinical lab licensed under chapter 483; a
3808 health maintenance organization certificated under part I of
3809 chapter 641; a blood bank; a plasma center; an industrial
3810 clinic; a renal dialysis facility; or a professional association
3811 partnership, corporation, joint venture, or other association
3812 for professional activity by health care providers.
3813 Section 101. This act shall take effect July 1, 2010.