Bill Text: FL S0622 | 2018 | Regular Session | Enrolled
Bill Title: Health Care Facility Regulation
Spectrum:
Status: (Passed) 2018-03-21 - Chapter No. 2018-24 [S0622 Detail]
Download: Florida-2018-S0622-Enrolled.html
ENROLLED
2018 Legislature CS for CS for SB 622, 2nd Engrossed
2018622er
1
2 An act relating to health care facility regulation;
3 creating s. 154.13, F.S.; providing that a designated
4 facility owned or operated by a public health trust
5 and located within the boundaries of a municipality is
6 under the exclusive jurisdiction of the county
7 creating the public health trust; amending ss.
8 381.0031, 381.004, 384.31, 395.009, 400.0625, and
9 409.905, F.S.; eliminating state licensure
10 requirements for clinical laboratories; requiring
11 clinical laboratories to be federally certified;
12 amending s. 381.915, F.S.; increasing the number of
13 years that a cancer center may participate in Tier 3
14 of the Florida Consortium of National Cancer Institute
15 Centers Program; increasing the number of years after
16 qualification that a certain Tier 3 cancer center may
17 pursue specified NCI designations; amending s.
18 383.313, F.S.; requiring a birth center to be
19 federally certified and meet specified requirements to
20 perform certain laboratory tests; repealing s.
21 383.335, F.S., relating to partial exemptions from
22 licensure requirements for certain facilities that
23 provide obstetrical and gynecological surgical
24 services; amending s. 395.002, F.S.; revising and
25 deleting definitions to remove the term “mobile
26 surgical facility”; conforming a cross-reference;
27 amending s. 395.003, F.S.; conforming provisions to
28 changes made by the act; authorizing certain
29 specialty-licensed children’s hospitals to provide
30 obstetrical services under certain circumstances;
31 creating s. 395.0091, F.S.; requiring the Agency for
32 Health Care Administration, in consultation with the
33 Board of Clinical Laboratory Personnel, to adopt rules
34 establishing criteria for alternate-site laboratory
35 testing; requiring specifications to be included in
36 the criteria; defining the term “alternate-site
37 testing”; amending ss. 395.0161 and 395.0163, F.S.;
38 deleting licensure and inspection requirements for
39 mobile surgical facilities to conform to changes made
40 by the act; amending s. 395.0197, F.S.; requiring the
41 manager of a hospital or ambulatory surgical center
42 internal risk management program to demonstrate
43 competence in specified administrative and health care
44 service areas; conforming provisions to changes made
45 by the act; repealing s. 395.1046, F.S., relating to
46 hospital complaint investigation procedures; amending
47 s. 395.1055, F.S.; requiring hospitals that provide
48 specified services to meet agency licensure
49 requirements; providing standards to be included in
50 licensure requirements; conforming a provision to
51 changes made by the act; requiring a level 2
52 background screening for personnel of distinct part
53 nursing units; requiring the agency to adopt rules
54 establishing standards for pediatric cardiac
55 catheterization and pediatric cardiovascular surgery
56 programs; providing requirements for such programs;
57 requiring pediatric cardiac programs to participate in
58 the clinical outcome reporting systems; revising
59 duties and membership of the pediatric cardiac
60 technical advisory panel; repealing ss. 395.10971 and
61 395.10972, F.S., relating to the purpose and the
62 establishment of the Health Care Risk Manager Advisory
63 Council, respectively; amending s. 395.10973, F.S.;
64 removing requirements relating to agency standards for
65 health care risk managers to conform provisions to
66 changes made by the act; repealing s. 395.10974, F.S.,
67 relating to licensure of health care risk managers,
68 qualifications, licensure, and fees; repealing s.
69 395.10975, F.S., relating to grounds for denial,
70 suspension, or revocation of a health care risk
71 manager’s license and an administrative fine; amending
72 s. 395.602, F.S.; deleting definitions for the terms
73 “emergency care hospital,” “essential access community
74 hospital,” “inactive rural hospital bed,” and “rural
75 primary care hospital”; amending s. 395.603, F.S.;
76 deleting provisions relating to deactivation of
77 general hospital beds by certain rural and emergency
78 care hospitals; repealing s. 395.604, F.S., relating
79 to other rural hospital programs; repealing s.
80 395.605, F.S., relating to emergency care hospitals;
81 amending s. 395.701, F.S.; revising the definition of
82 the term “hospital” to exclude hospitals operated by a
83 state agency; amending s. 400.191, F.S.; removing the
84 30-month reporting timeframe for the Nursing Home
85 Guide; amending s. 400.464, F.S.; requiring that a
86 license issued to a home health agency on or after a
87 specified date specify the services the organization
88 is authorized to perform and whether the services
89 constitute skilled care; providing that the provision
90 or advertising of certain services constitutes
91 unlicensed activity under certain circumstances;
92 authorizing certain persons, entities or organizations
93 providing home health services to voluntarily apply
94 for a certificate of exemption from licensure by
95 providing certain information to the agency; providing
96 that the certificate is valid for a specified time and
97 is nontransferable; authorizing the agency to charge a
98 fee for the certificate; amending s. 400.471, F.S.;
99 revising home health agency licensure requirements;
100 providing requirements for proof of accreditation for
101 home health agencies applying for change of ownership
102 or the addition of skilled care services; removing a
103 provision prohibiting the agency from issuing a
104 license to a home health agency that fails to satisfy
105 the requirements of a Medicare certification survey
106 from the agency; amending s. 400.474, F.S.; revising
107 conditions for the imposition of a fine against a home
108 health agency; amending s. 400.476, F.S.; requiring a
109 home health agency providing skilled nursing care to
110 have a director of nursing; amending s. 400.484, F.S.;
111 imposing administrative fines on home health agencies
112 for specified classes of violations; amending s.
113 400.497, F.S.; requiring the agency to adopt, publish,
114 and enforce rules establishing standards for
115 certificates of exemption; amending s. 400.506, F.S.;
116 specifying a criminal penalty for any person who owns,
117 operates, or maintains an unlicensed nurse registry
118 that fails to cease operation immediately and apply
119 for a license after notification from the agency;
120 revising provisions authorizing the agency to impose a
121 fine on a nurse registry that fails to cease operation
122 after agency notification; revising circumstances
123 under which the agency is authorized to deny, suspend,
124 or revoke a license or impose a fine on a nurse
125 registry; prohibiting a nurse registry from
126 monitoring, supervising, managing, or training a
127 certain caregiver who is an independent contractor;
128 amending s. 400.606, F.S.; removing a requirement that
129 an existing licensed health care provider’s hospice
130 licensure application be accompanied by a copy of the
131 most recent profit-loss statement and licensure
132 inspection report; amending s. 400.925, F.S.; revising
133 the definition of the term “home medical equipment”;
134 amending s. 400.931, F.S.; requiring a home medical
135 equipment provider to notify the agency of certain
136 personnel changes within a specified timeframe;
137 amending s. 400.933, F.S.; requiring the agency to
138 accept the submission of a valid medical oxygen retail
139 establishment permit issued by the Department of
140 Business and Professional Regulation in lieu of an
141 agency inspection for licensure; amending s. 400.980,
142 F.S.; revising the timeframe within which a health
143 care services pool registrant must provide the agency
144 with certain changes of information; amending s.
145 400.9935, F.S.; specifying that a voluntary
146 certificate of exemption may be valid for up to 2
147 years; amending s. 408.036, F.S.; conforming
148 provisions to changes made by the act; deleting
149 obsolete provisions relating to certificate of need
150 requirements for specified services; amending s.
151 408.0361, F.S.; providing an exception for a hospital
152 to become a Level I Adult Cardiovascular provider if
153 certain requirements are met; amending s. 408.05,
154 F.S.; requiring the agency to contract with the
155 Society of Thoracic Surgeons and the American College
156 of Cardiology for the collection of certain data for
157 publication on the agency’s website for certain
158 purposes; amending s. 408.061, F.S.; excluding
159 hospitals operated by state agencies from certain
160 financial reporting requirements; conforming a cross
161 reference; amending s. 408.07, F.S.; deleting the
162 definition for the term “clinical laboratory”;
163 amending s. 408.20, F.S.; exempting hospitals operated
164 by any state agency from assessments against the
165 Health Care Trust Fund to fund certain agency
166 activities; repealing s. 408.7056, F.S., relating to
167 the Subscriber Assistance Program; amending s.
168 408.803, F.S.; defining the term “relative” for
169 purposes of the Health Care Licensing Procedures Act;
170 amending s. 408.806, F.S.; authorizing licensees who
171 hold licenses for multiple providers to request that
172 the agency align related license expiration dates;
173 authorizing the agency to issue licenses for an
174 abbreviated licensure period and to charge a prorated
175 licensure fee; amending s. 408.809, F.S.; expanding
176 the scope of persons subject to a level 2 background
177 screening to include any employee of a licensee who is
178 a controlling interest and certain part-time
179 contractors; amending s. 408.810, F.S.; providing that
180 an applicant for change of ownership licensure is
181 exempt from furnishing proof of financial ability to
182 operate if certain conditions are met; authorizing the
183 agency to adopt rules governing circumstances under
184 which a controlling interest may act in certain legal
185 capacities on behalf of a patient or client; requiring
186 a licensee to ensure that certain persons do not hold
187 an ownership interest if the licensee is not organized
188 as or owned by a publicly traded corporation; defining
189 the term “publicly traded corporation”; amending s.
190 408.812, F.S.; providing that certain unlicensed
191 activity by a provider constitutes abuse and neglect;
192 clarifying that the agency may impose a fine or
193 penalty, as prescribed in an authorizing statute, if
194 an unlicensed provider who has received notification
195 fails to cease operation; authorizing the agency to
196 revoke all licenses and impose a fine or penalties
197 upon a controlling interest or licensee who has an
198 interest in more than one provider and who fails to
199 license a provider rendering services that require
200 licensure in certain circumstances; amending s.
201 408.820, F.S.; deleting certain exemptions from part
202 II of ch. 408, F.S., for specified providers to
203 conform provisions to changes made by the act;
204 amending s. 409.907, F.S.; removing the agency’s
205 authority to consider certain factors in determining
206 whether to enter into, and in maintaining, a Medicaid
207 provider agreement; amending s. 429.02, F.S.; revising
208 definitions of the terms “assisted living facility”
209 and “personal services”; amending s. 429.04, F.S.;
210 providing additional exemptions from licensure as an
211 assisted living facility; requiring a person or entity
212 asserting the exemption to provide documentation that
213 substantiates the claim upon agency investigation of
214 unlicensed activity; amending s. 429.08, F.S.;
215 providing criminal penalties and fines for a person
216 who rents or otherwise maintains a building or
217 property used as an unlicensed assisted living
218 facility; providing criminal penalties and fines for a
219 person who owns, operates, or maintains an unlicensed
220 assisted living facility after receiving notice from
221 the agency; amending s. 429.176, F.S.; prohibiting an
222 assisted living facility from operating for more than
223 a specified time without an administrator who has
224 completed certain educational requirements; amending
225 s. 429.24, F.S.; providing that 30-day written notice
226 of rate increase for residency in an assisted living
227 facility is not required in certain situations;
228 amending s. 429.28, F.S.; revising the assisted living
229 facility resident bill of rights to include assistance
230 with obtaining access to adequate and appropriate
231 health care; defining the term “adequate and
232 appropriate health care”; deleting a requirement that
233 the agency conduct at least one monitoring visit under
234 certain circumstances; deleting provisions authorizing
235 the agency to conduct periodic followup inspections
236 and complaint investigations under certain
237 circumstances; amending s. 429.294, F.S.; deleting the
238 specified timeframe within which an assisted living
239 facility must provide complete copies of a resident’s
240 records in an investigation of resident’s rights;
241 amending s. 429.34, F.S.; authorizing the agency to
242 inspect and investigate assisted living facilities as
243 necessary to determine compliance with certain laws;
244 removing a provision requiring the agency to inspect
245 each licensed assisted living facility at least
246 biennially; authorizing the agency to conduct
247 monitoring visits of each facility cited for prior
248 violations under certain circumstances; amending s.
249 429.52, F.S.; requiring an assisted living facility
250 administrator to complete required training and
251 education within a specified timeframe; amending s.
252 435.04, F.S.; providing that security background
253 investigations must ensure that a person has not been
254 arrested for, and is not awaiting final disposition
255 of, certain offenses; requiring that security
256 background investigations for purposes of
257 participation in the Medicaid program screen for
258 violations of federal or state law, rule, or
259 regulation governing any state Medicaid program, the
260 Medicare program, or any other publicly funded federal
261 or state health care or health insurance program;
262 specifying offenses under federal law or any state law
263 that the security background investigations must
264 screen for; amending s. 456.054, F.S.; prohibiting any
265 person or entity from paying or receiving a kickback
266 for referring patients to a clinical laboratory;
267 prohibiting a clinical laboratory from providing
268 personnel to perform certain functions or duties in a
269 health care practitioner’s office or dialysis
270 facility; providing an exception; prohibiting a
271 clinical laboratory from leasing space in any part of
272 a health care practitioner’s office or dialysis
273 facility; repealing part I of ch. 483, F.S., relating
274 to clinical laboratories; amending s. 483.294, F.S.;
275 removing a requirement that the agency inspect
276 multiphasic health testing centers at least once
277 annually; amending s. 483.801, F.S.; providing an
278 exemption from regulation for certain persons employed
279 by certain laboratories; amending s. 483.803, F.S.;
280 revising definitions of the terms “clinical
281 laboratory” and “clinical laboratory examination”;
282 removing a cross-reference; amending s. 641.511, F.S.;
283 revising health maintenance organization subscriber
284 grievance reporting requirements; repealing s. 641.60,
285 F.S., relating to the Statewide Managed Care Ombudsman
286 Committee; repealing s. 641.65, F.S., relating to
287 district managed care ombudsman committees; repealing
288 s. 641.67, F.S., relating to a district managed care
289 ombudsman committee, exemption from public records
290 requirements, and exceptions; repealing s. 641.68,
291 F.S., relating to a district managed care ombudsman
292 committee and exemption from public meeting
293 requirements; repealing s. 641.70, F.S., relating to
294 agency duties relating to the Statewide Managed Care
295 Ombudsman Committee and the district managed care
296 ombudsman committees; repealing s. 641.75, F.S.,
297 relating to immunity from liability and limitation on
298 testimony; amending s. 945.36, F.S.; authorizing law
299 enforcement personnel to conduct drug tests on certain
300 inmates and releasees; amending ss. 20.43, 220.1845,
301 376.30781, 376.86, 381.0034, 381.0405, 383.14, 383.30,
302 383.301, 383.302, 383.305, 383.309, 383.33, 385.211,
303 394.4787, 395.001, 395.7015, 400.9905, 408.033,
304 408.802, 409.9116, 409.975, 429.19, 456.001, 456.057,
305 456.076, 458.307, 458.345, 459.021, 483.813, 483.823,
306 491.003, 627.351, 627.602, 627.6406, 627.64194,
307 627.6513, 627.6574, 641.185, 641.31, 641.312,
308 641.3154, 641.51, 641.515, 641.55, 766.118, 766.202,
309 1009.65, and 1011.52, F.S.; conforming provisions to
310 changes made by the act; providing an effective date.
311
312 Be It Enacted by the Legislature of the State of Florida:
313
314 Section 1. Paragraph (g) of subsection (3) of section
315 20.43, Florida Statutes, is amended to read:
316 20.43 Department of Health.—There is created a Department
317 of Health.
318 (3) The following divisions of the Department of Health are
319 established:
320 (g) Division of Medical Quality Assurance, which is
321 responsible for the following boards and professions established
322 within the division:
323 1. The Board of Acupuncture, created under chapter 457.
324 2. The Board of Medicine, created under chapter 458.
325 3. The Board of Osteopathic Medicine, created under chapter
326 459.
327 4. The Board of Chiropractic Medicine, created under
328 chapter 460.
329 5. The Board of Podiatric Medicine, created under chapter
330 461.
331 6. Naturopathy, as provided under chapter 462.
332 7. The Board of Optometry, created under chapter 463.
333 8. The Board of Nursing, created under part I of chapter
334 464.
335 9. Nursing assistants, as provided under part II of chapter
336 464.
337 10. The Board of Pharmacy, created under chapter 465.
338 11. The Board of Dentistry, created under chapter 466.
339 12. Midwifery, as provided under chapter 467.
340 13. The Board of Speech-Language Pathology and Audiology,
341 created under part I of chapter 468.
342 14. The Board of Nursing Home Administrators, created under
343 part II of chapter 468.
344 15. The Board of Occupational Therapy, created under part
345 III of chapter 468.
346 16. Respiratory therapy, as provided under part V of
347 chapter 468.
348 17. Dietetics and nutrition practice, as provided under
349 part X of chapter 468.
350 18. The Board of Athletic Training, created under part XIII
351 of chapter 468.
352 19. The Board of Orthotists and Prosthetists, created under
353 part XIV of chapter 468.
354 20. Electrolysis, as provided under chapter 478.
355 21. The Board of Massage Therapy, created under chapter
356 480.
357 22. The Board of Clinical Laboratory Personnel, created
358 under part II III of chapter 483.
359 23. Medical physicists, as provided under part IV of
360 chapter 483.
361 24. The Board of Opticianry, created under part I of
362 chapter 484.
363 25. The Board of Hearing Aid Specialists, created under
364 part II of chapter 484.
365 26. The Board of Physical Therapy Practice, created under
366 chapter 486.
367 27. The Board of Psychology, created under chapter 490.
368 28. School psychologists, as provided under chapter 490.
369 29. The Board of Clinical Social Work, Marriage and Family
370 Therapy, and Mental Health Counseling, created under chapter
371 491.
372 30. Emergency medical technicians and paramedics, as
373 provided under part III of chapter 401.
374 Section 2. Section 154.13, Florida Statutes, is created to
375 read:
376 154.13 Designated facilities; jurisdiction.—Any designated
377 facility owned or operated by a public health trust and located
378 within the boundaries of a municipality is under the exclusive
379 jurisdiction of the county creating the public health trust and
380 is not within the jurisdiction of the municipality.
381 Section 3. Paragraph (k) of subsection (2) of section
382 220.1845, Florida Statutes, is amended to read:
383 220.1845 Contaminated site rehabilitation tax credit.—
384 (2) AUTHORIZATION FOR TAX CREDIT; LIMITATIONS.—
385 (k) In order to encourage the construction and operation of
386 a new health care facility as defined in s. 408.032 or s.
387 408.07, or a health care provider as defined in s. 408.07 or s.
388 408.7056, on a brownfield site, an applicant for a tax credit
389 may claim an additional 25 percent of the total site
390 rehabilitation costs, not to exceed $500,000, if the applicant
391 meets the requirements of this paragraph. In order to receive
392 this additional tax credit, the applicant must provide
393 documentation indicating that the construction of the health
394 care facility or health care provider by the applicant on the
395 brownfield site has received a certificate of occupancy or a
396 license or certificate has been issued for the operation of the
397 health care facility or health care provider.
398 Section 4. Paragraph (f) of subsection (3) of section
399 376.30781, Florida Statutes, is amended to read:
400 376.30781 Tax credits for rehabilitation of drycleaning
401 solvent-contaminated sites and brownfield sites in designated
402 brownfield areas; application process; rulemaking authority;
403 revocation authority.—
404 (3)
405 (f) In order to encourage the construction and operation of
406 a new health care facility or a health care provider, as defined
407 in s. 408.032 or, s. 408.07, or s. 408.7056, on a brownfield
408 site, an applicant for a tax credit may claim an additional 25
409 percent of the total site rehabilitation costs, not to exceed
410 $500,000, if the applicant meets the requirements of this
411 paragraph. In order to receive this additional tax credit, the
412 applicant must provide documentation indicating that the
413 construction of the health care facility or health care provider
414 by the applicant on the brownfield site has received a
415 certificate of occupancy or a license or certificate has been
416 issued for the operation of the health care facility or health
417 care provider.
418 Section 5. Subsection (1) of section 376.86, Florida
419 Statutes, is amended to read:
420 376.86 Brownfield Areas Loan Guarantee Program.—
421 (1) The Brownfield Areas Loan Guarantee Council is created
422 to review and approve or deny, by a majority vote of its
423 membership, the situations and circumstances for participation
424 in partnerships by agreements with local governments, financial
425 institutions, and others associated with the redevelopment of
426 brownfield areas pursuant to the Brownfields Redevelopment Act
427 for a limited state guaranty of up to 5 years of loan guarantees
428 or loan loss reserves issued pursuant to law. The limited state
429 loan guaranty applies only to 50 percent of the primary lenders
430 loans for redevelopment projects in brownfield areas. If the
431 redevelopment project is for affordable housing, as defined in
432 s. 420.0004, in a brownfield area, the limited state loan
433 guaranty applies to 75 percent of the primary lender’s loan. If
434 the redevelopment project includes the construction and
435 operation of a new health care facility or a health care
436 provider, as defined in s. 408.032 or, s. 408.07, or s.
437 408.7056, on a brownfield site and the applicant has obtained
438 documentation in accordance with s. 376.30781 indicating that
439 the construction of the health care facility or health care
440 provider by the applicant on the brownfield site has received a
441 certificate of occupancy or a license or certificate has been
442 issued for the operation of the health care facility or health
443 care provider, the limited state loan guaranty applies to 75
444 percent of the primary lender’s loan. A limited state guaranty
445 of private loans or a loan loss reserve is authorized for
446 lenders licensed to operate in the state upon a determination by
447 the council that such an arrangement would be in the public
448 interest and the likelihood of the success of the loan is great.
449 Section 6. Subsection (2) of section 381.0031, Florida
450 Statutes, is amended to read:
451 381.0031 Epidemiological research; report of diseases of
452 public health significance to department.—
453 (2) Any practitioner licensed in this state to practice
454 medicine, osteopathic medicine, chiropractic medicine,
455 naturopathy, or veterinary medicine; any hospital licensed under
456 part I of chapter 395; or any laboratory appropriately certified
457 by the Centers for Medicare and Medicaid Services under the
458 federal Clinical Laboratory Improvement Amendments and the
459 federal rules adopted thereunder which licensed under chapter
460 483 that diagnoses or suspects the existence of a disease of
461 public health significance shall immediately report the fact to
462 the Department of Health.
463 Section 7. Subsection (3) of section 381.0034, Florida
464 Statutes, is amended to read:
465 381.0034 Requirement for instruction on HIV and AIDS.—
466 (3) The department shall require, as a condition of
467 granting a license under chapter 467 or part II III of chapter
468 483, that an applicant making initial application for licensure
469 complete an educational course acceptable to the department on
470 human immunodeficiency virus and acquired immune deficiency
471 syndrome. Upon submission of an affidavit showing good cause, an
472 applicant who has not taken a course at the time of licensure
473 shall be allowed 6 months to complete this requirement.
474 Section 8. Paragraph (c) of subsection (4) of section
475 381.004, Florida Statutes, is amended to read:
476 381.004 HIV testing.—
477 (4) HUMAN IMMUNODEFICIENCY VIRUS TESTING REQUIREMENTS;
478 REGISTRATION WITH THE DEPARTMENT OF HEALTH; EXEMPTIONS FROM
479 REGISTRATION.—No county health department and no other person in
480 this state shall conduct or hold themselves out to the public as
481 conducting a testing program for acquired immune deficiency
482 syndrome or human immunodeficiency virus status without first
483 registering with the Department of Health, reregistering each
484 year, complying with all other applicable provisions of state
485 law, and meeting the following requirements:
486 (c) The program shall have all laboratory procedures
487 performed in a laboratory appropriately certified by the Centers
488 for Medicare and Medicaid Services under the federal Clinical
489 Laboratory Improvement Amendments and the federal rules adopted
490 thereunder licensed under the provisions of chapter 483.
491 Section 9. Paragraph (f) of subsection (4) of section
492 381.0405, Florida Statutes, is amended to read:
493 381.0405 Office of Rural Health.—
494 (4) COORDINATION.—The office shall:
495 (f) Assume responsibility for state coordination of the
496 Rural Hospital Transition Grant Program, the Essential Access
497 Community Hospital Program, and other federal rural health care
498 programs.
499 Section 10. Paragraph (c) of subsection (4) of section
500 381.915, Florida Statutes, is amended to read:
501 381.915 Florida Consortium of National Cancer Institute
502 Centers Program.—
503 (4) Tier designations and corresponding weights within the
504 Florida Consortium of National Cancer Institute Centers Program
505 are as follows:
506 (c) Tier 3: Florida-based cancer centers seeking
507 designation as either a NCI-designated cancer center or NCI
508 designated comprehensive cancer center, which shall be weighted
509 at 1.0.
510 1. A cancer center shall meet the following minimum
511 criteria to be considered eligible for Tier 3 designation in any
512 given fiscal year:
513 a. Conducting cancer-related basic scientific research and
514 cancer-related population scientific research;
515 b. Offering and providing the full range of diagnostic and
516 treatment services on site, as determined by the Commission on
517 Cancer of the American College of Surgeons;
518 c. Hosting or conducting cancer-related interventional
519 clinical trials that are registered with the NCI’s Clinical
520 Trials Reporting Program;
521 d. Offering degree-granting programs or affiliating with
522 universities through degree-granting programs accredited or
523 approved by a nationally recognized agency and offered through
524 the center or through the center in conjunction with another
525 institution accredited by the Commission on Colleges of the
526 Southern Association of Colleges and Schools;
527 e. Providing training to clinical trainees, medical
528 trainees accredited by the Accreditation Council for Graduate
529 Medical Education or the American Osteopathic Association, and
530 postdoctoral fellows recently awarded a doctorate degree; and
531 f. Having more than $5 million in annual direct costs
532 associated with their total NCI peer-reviewed grant funding.
533 2. The General Appropriations Act or accompanying
534 legislation may limit the number of cancer centers which shall
535 receive Tier 3 designations or provide additional criteria for
536 such designation.
537 3. A cancer center’s participation in Tier 3 shall be
538 limited to 6 5 years.
539 4. A cancer center that qualifies as a designated Tier 3
540 center under the criteria provided in subparagraph 1. by July 1,
541 2014, is authorized to pursue NCI designation as a cancer center
542 or a comprehensive cancer center for 6 5 years after
543 qualification.
544 Section 11. Paragraph (a) of subsection (2) of section
545 383.14, Florida Statutes, is amended to read:
546 383.14 Screening for metabolic disorders, other hereditary
547 and congenital disorders, and environmental risk factors.—
548 (2) RULES.—
549 (a) After consultation with the Genetics and Newborn
550 Screening Advisory Council, the department shall adopt and
551 enforce rules requiring that every newborn in this state shall:
552 1. Before becoming 1 week of age, be subjected to a test
553 for phenylketonuria;
554 2. Be tested for any condition included on the federal
555 Recommended Uniform Screening Panel which the council advises
556 the department should be included under the state’s screening
557 program. After the council recommends that a condition be
558 included, the department shall submit a legislative budget
559 request to seek an appropriation to add testing of the condition
560 to the newborn screening program. The department shall expand
561 statewide screening of newborns to include screening for such
562 conditions within 18 months after the council renders such
563 advice, if a test approved by the United States Food and Drug
564 Administration or a test offered by an alternative vendor which
565 is compatible with the clinical standards established under part
566 I of chapter 483 is available. If such a test is not available
567 within 18 months after the council makes its recommendation, the
568 department shall implement such screening as soon as a test
569 offered by the United States Food and Drug Administration or by
570 an alternative vendor is available; and
571 3. At the appropriate age, be tested for such other
572 metabolic diseases and hereditary or congenital disorders as the
573 department may deem necessary from time to time.
574 Section 12. Section 383.30, Florida Statutes, is amended to
575 read:
576 383.30 Birth Center Licensure Act; short title.—Sections
577 383.30-383.332 383.30-383.335 shall be known and may be cited as
578 the “Birth Center Licensure Act.”
579 Section 13. Section 383.301, Florida Statutes, is amended
580 to read:
581 383.301 Licensure and regulation of birth centers;
582 legislative intent.—It is the intent of the Legislature to
583 provide for the protection of public health and safety in the
584 establishment, maintenance, and operation of birth centers by
585 providing for licensure of birth centers and for the
586 development, establishment, and enforcement of minimum standards
587 with respect to birth centers. The requirements of part II of
588 chapter 408 shall apply to the provision of services that
589 require licensure pursuant to ss. 383.30-383.332 383.30-383.335
590 and part II of chapter 408 and to entities licensed by or
591 applying for such licensure from the Agency for Health Care
592 Administration pursuant to ss. 383.30-383.332 383.30-383.335. A
593 license issued by the agency is required in order to operate a
594 birth center in this state.
595 Section 14. Section 383.302, Florida Statutes, is amended
596 to read:
597 383.302 Definitions of terms used in ss. 383.30-383.332
598 383.30-383.335.—As used in ss. 383.30-383.332 383.30-383.335,
599 the term:
600 (1) “Agency” means the Agency for Health Care
601 Administration.
602 (2) “Birth center” means any facility, institution, or
603 place, which is not an ambulatory surgical center or a hospital
604 or in a hospital, in which births are planned to occur away from
605 the mother’s usual residence following a normal, uncomplicated,
606 low-risk pregnancy.
607 (3) “Clinical staff” means individuals employed full time
608 or part time by a birth center who are licensed or certified to
609 provide care at childbirth.
610 (4) “Consultant” means a physician licensed pursuant to
611 chapter 458 or chapter 459 who agrees to provide advice and
612 services to a birth center and who either:
613 (a) Is certified or eligible for certification by the
614 American Board of Obstetrics and Gynecology, or
615 (b) Has hospital obstetrical privileges.
616 (5) “Governing body” means any individual, group,
617 corporation, or institution which is responsible for the overall
618 operation and maintenance of a birth center.
619 (6) “Governmental unit” means the state or any county,
620 municipality, or other political subdivision or any department,
621 division, board, or other agency of any of the foregoing.
622 (7) “Licensed facility” means a facility licensed in
623 accordance with s. 383.305.
624 (8) “Low-risk pregnancy” means a pregnancy which is
625 expected to result in an uncomplicated birth, as determined
626 through risk criteria developed by rule of the department, and
627 which is accompanied by adequate prenatal care.
628 (9) “Person” means any individual, firm, partnership,
629 corporation, company, association, institution, or joint stock
630 association and means any legal successor of any of the
631 foregoing.
632 (10) “Premises” means those buildings, beds, and facilities
633 located at the main address of the licensee and all other
634 buildings, beds, and facilities for the provision of maternity
635 care located in such reasonable proximity to the main address of
636 the licensee as to appear to the public to be under the dominion
637 and control of the licensee.
638 Section 15. Subsection (1) of section 383.305, Florida
639 Statutes, is amended to read:
640 383.305 Licensure; fees.—
641 (1) In accordance with s. 408.805, an applicant or a
642 licensee shall pay a fee for each license application submitted
643 under ss. 383.30-383.332 383.30-383.335 and part II of chapter
644 408. The amount of the fee shall be established by rule.
645 Section 16. Subsection (1) of section 383.309, Florida
646 Statutes, is amended to read:
647 383.309 Minimum standards for birth centers; rules and
648 enforcement.—
649 (1) The agency shall adopt and enforce rules to administer
650 ss. 383.30-383.332 383.30-383.335 and part II of chapter 408,
651 which rules shall include, but are not limited to, reasonable
652 and fair minimum standards for ensuring that:
653 (a) Sufficient numbers and qualified types of personnel and
654 occupational disciplines are available at all times to provide
655 necessary and adequate patient care and safety.
656 (b) Infection control, housekeeping, sanitary conditions,
657 disaster plan, and medical record procedures that will
658 adequately protect patient care and provide safety are
659 established and implemented.
660 (c) Licensed facilities are established, organized, and
661 operated consistent with established programmatic standards.
662 Section 17. Subsection (1) of section 383.313, Florida
663 Statutes, is amended to read:
664 383.313 Performance of laboratory and surgical services;
665 use of anesthetic and chemical agents.—
666 (1) LABORATORY SERVICES.—A birth center may collect
667 specimens for those tests that are requested under protocol. A
668 birth center must obtain and continuously maintain certification
669 by the Centers for Medicare and Medicaid Services under the
670 federal Clinical Laboratory Improvement Amendments and the
671 federal rules adopted thereunder in order to may perform simple
672 laboratory tests specified, as defined by rule of the agency,
673 and which are appropriate to meet the needs of the patient is
674 exempt from the requirements of chapter 483, provided no more
675 than five physicians are employed by the birth center and
676 testing is conducted exclusively in connection with the
677 diagnosis and treatment of clients of the birth center.
678 Section 18. Subsection (1) and paragraph (a) of subsection
679 (2) of section 383.33, Florida Statutes, are amended to read:
680 383.33 Administrative penalties; moratorium on admissions.—
681 (1) In addition to the requirements of part II of chapter
682 408, the agency may impose an administrative fine not to exceed
683 $500 per violation per day for the violation of any provision of
684 ss. 383.30-383.332 383.30-383.335, part II of chapter 408, or
685 applicable rules.
686 (2) In determining the amount of the fine to be levied for
687 a violation, as provided in this section, the following factors
688 shall be considered:
689 (a) The severity of the violation, including the
690 probability that death or serious harm to the health or safety
691 of any person will result or has resulted; the severity of the
692 actual or potential harm; and the extent to which the provisions
693 of ss. 383.30-383.332 383.30-383.335, part II of chapter 408, or
694 applicable rules were violated.
695 Section 19. Section 383.335, Florida Statutes, is repealed.
696 Section 20. Section 384.31, Florida Statutes, is amended to
697 read:
698 384.31 Testing of pregnant women; duty of the attendant.
699 Every person, including every physician licensed under chapter
700 458 or chapter 459 or midwife licensed under part I of chapter
701 464 or chapter 467, attending a pregnant woman for conditions
702 relating to pregnancy during the period of gestation and
703 delivery shall cause the woman to be tested for sexually
704 transmissible diseases, including HIV, as specified by
705 department rule. Testing shall be performed by a laboratory
706 appropriately certified by the Centers for Medicare and Medicaid
707 Services under the federal Clinical Laboratory Improvement
708 Amendments and the federal rules adopted thereunder approved for
709 such purposes under part I of chapter 483. The woman shall be
710 informed of the tests that will be conducted and of her right to
711 refuse testing. If a woman objects to testing, a written
712 statement of objection, signed by the woman, shall be placed in
713 the woman’s medical record and no testing shall occur.
714 Section 21. Subsection (2) of section 385.211, Florida
715 Statutes, is amended to read:
716 385.211 Refractory and intractable epilepsy treatment and
717 research at recognized medical centers.—
718 (2) Notwithstanding chapter 893, medical centers recognized
719 pursuant to s. 381.925, or an academic medical research
720 institution legally affiliated with a licensed children’s
721 specialty hospital as defined in s. 395.002(27) s. 395.002(28)
722 that contracts with the Department of Health, may conduct
723 research on cannabidiol and low-THC cannabis. This research may
724 include, but is not limited to, the agricultural development,
725 production, clinical research, and use of liquid medical
726 derivatives of cannabidiol and low-THC cannabis for the
727 treatment for refractory or intractable epilepsy. The authority
728 for recognized medical centers to conduct this research is
729 derived from 21 C.F.R. parts 312 and 316. Current state or
730 privately obtained research funds may be used to support the
731 activities described in this section.
732 Section 22. Subsection (7) of section 394.4787, Florida
733 Statutes, is amended to read:
734 394.4787 Definitions; ss. 394.4786, 394.4787, 394.4788, and
735 394.4789.—As used in this section and ss. 394.4786, 394.4788,
736 and 394.4789:
737 (7) “Specialty psychiatric hospital” means a hospital
738 licensed by the agency pursuant to s. 395.002(27) s. 395.002(28)
739 and part II of chapter 408 as a specialty psychiatric hospital.
740 Section 23. Section 395.001, Florida Statutes, is amended
741 to read:
742 395.001 Legislative intent.—It is the intent of the
743 Legislature to provide for the protection of public health and
744 safety in the establishment, construction, maintenance, and
745 operation of hospitals and, ambulatory surgical centers, and
746 mobile surgical facilities by providing for licensure of same
747 and for the development, establishment, and enforcement of
748 minimum standards with respect thereto.
749 Section 24. Present subsections (22) through (33) of
750 section 395.002, Florida Statutes, are redesignated as
751 subsections (21) through (32), respectively, and subsections (3)
752 and (16) of that section and present subsections (21) and (23)
753 of that section are amended, to read:
754 395.002 Definitions.—As used in this chapter:
755 (3) “Ambulatory surgical center” or “mobile surgical
756 facility” means a facility the primary purpose of which is to
757 provide elective surgical care, in which the patient is admitted
758 to and discharged from such facility within the same working day
759 and is not permitted to stay overnight, and which is not part of
760 a hospital. However, a facility existing for the primary purpose
761 of performing terminations of pregnancy, an office maintained by
762 a physician for the practice of medicine, or an office
763 maintained for the practice of dentistry may shall not be
764 construed to be an ambulatory surgical center, provided that any
765 facility or office which is certified or seeks certification as
766 a Medicare ambulatory surgical center shall be licensed as an
767 ambulatory surgical center pursuant to s. 395.003. Any structure
768 or vehicle in which a physician maintains an office and
769 practices surgery, and which can appear to the public to be a
770 mobile office because the structure or vehicle operates at more
771 than one address, shall be construed to be a mobile surgical
772 facility.
773 (16) “Licensed facility” means a hospital or, ambulatory
774 surgical center, or mobile surgical facility licensed in
775 accordance with this chapter.
776 (21) “Mobile surgical facility” is a mobile facility in
777 which licensed health care professionals provide elective
778 surgical care under contract with the Department of Corrections
779 or a private correctional facility operating pursuant to chapter
780 957 and in which inmate patients are admitted to and discharged
781 from said facility within the same working day and are not
782 permitted to stay overnight. However, mobile surgical facilities
783 may only provide health care services to the inmate patients of
784 the Department of Corrections, or inmate patients of a private
785 correctional facility operating pursuant to chapter 957, and not
786 to the general public.
787 (22)(23) “Premises” means those buildings, beds, and
788 equipment located at the address of the licensed facility and
789 all other buildings, beds, and equipment for the provision of
790 hospital or, ambulatory surgical, or mobile surgical care
791 located in such reasonable proximity to the address of the
792 licensed facility as to appear to the public to be under the
793 dominion and control of the licensee. For any licensee that is a
794 teaching hospital as defined in s. 408.07 s. 408.07(45),
795 reasonable proximity includes any buildings, beds, services,
796 programs, and equipment under the dominion and control of the
797 licensee that are located at a site with a main address that is
798 within 1 mile of the main address of the licensed facility; and
799 all such buildings, beds, and equipment may, at the request of a
800 licensee or applicant, be included on the facility license as a
801 single premises.
802 Section 25. Paragraphs (a) and (b) of subsection (1),
803 paragraph (b) of subsection (2), and paragraph (b) of subsection
804 (6) of section 395.003, Florida Statutes, are amended to read:
805 395.003 Licensure; denial, suspension, and revocation.—
806 (1)(a) The requirements of part II of chapter 408 apply to
807 the provision of services that require licensure pursuant to ss.
808 395.001-395.1065 and part II of chapter 408 and to entities
809 licensed by or applying for such licensure from the Agency for
810 Health Care Administration pursuant to ss. 395.001-395.1065. A
811 license issued by the agency is required in order to operate a
812 hospital or, ambulatory surgical center, or mobile surgical
813 facility in this state.
814 (b)1. It is unlawful for a person to use or advertise to
815 the public, in any way or by any medium whatsoever, any facility
816 as a “hospital,” or “ambulatory surgical center,” or “mobile
817 surgical facility” unless such facility has first secured a
818 license under the provisions of this part.
819 2. This part does not apply to veterinary hospitals or to
820 commercial business establishments using the word “hospital,” or
821 “ambulatory surgical center,” or “mobile surgical facility” as a
822 part of a trade name if no treatment of human beings is
823 performed on the premises of such establishments.
824 (2)
825 (b) The agency shall, at the request of a licensee that is
826 a teaching hospital as defined in s. 408.07 s. 408.07(45), issue
827 a single license to a licensee for facilities that have been
828 previously licensed as separate premises, provided such
829 separately licensed facilities, taken together, constitute the
830 same premises as defined in s. 395.002 s. 395.002(23). Such
831 license for the single premises shall include all of the beds,
832 services, and programs that were previously included on the
833 licenses for the separate premises. The granting of a single
834 license under this paragraph may shall not in any manner reduce
835 the number of beds, services, or programs operated by the
836 licensee.
837 (6)
838 (b) A specialty-licensed children’s hospital that has
839 licensed neonatal intensive care unit beds and is located in
840 District 5 or District 11, as defined in s. 408.032, as of
841 January 1, 2018, a county with a population of 1,750,000 or more
842 may provide obstetrical services, in accordance with the
843 pertinent guidelines promulgated by the American College of
844 Obstetricians and Gynecologists and with verification of
845 guidelines and compliance with internal safety standards by the
846 Voluntary Review for Quality of Care Program of the American
847 College of Obstetricians and Gynecologists and in compliance
848 with the agency’s rules pertaining to the obstetrical department
849 in a hospital and offer healthy mothers all necessary critical
850 care equipment, services, and the capability of providing up to
851 10 beds for labor and delivery care, which services are
852 restricted to the diagnosis, care, and treatment of pregnant
853 women of any age who have documentation by an examining
854 physician that includes information regarding:
855 1. At least one fetal characteristic or condition diagnosed
856 intra-utero that would characterize the pregnancy or delivery as
857 high risk including structural abnormalities of the digestive,
858 central nervous, and cardiovascular systems and disorders of
859 genetic malformations and skeletal dysplasia, acute metabolic
860 emergencies, and babies of mothers with rheumatologic disorders;
861 or
862 2. Medical advice or a diagnosis indicating that the fetus
863 may require at least one perinatal intervention.
864
865 This paragraph shall not preclude a specialty-licensed
866 children’s hospital from complying with s. 395.1041 or the
867 Emergency Medical Treatment and Active Labor Act, 42 U.S.C.
868 1395dd.
869 Section 26. Subsection (1) of section 395.009, Florida
870 Statutes, is amended to read:
871 395.009 Minimum standards for clinical laboratory test
872 results and diagnostic X-ray results; prerequisite for issuance
873 or renewal of license.—
874 (1) As a requirement for issuance or renewal of its
875 license, each licensed facility shall require that all clinical
876 laboratory tests performed by or for the licensed facility be
877 performed by a clinical laboratory appropriately certified by
878 the Centers for Medicare and Medicaid Services under the federal
879 Clinical Laboratory Improvement Amendments and the federal rules
880 adopted thereunder licensed under the provisions of chapter 483.
881 Section 27. Section 395.0091, Florida Statutes, is created
882 to read:
883 395.0091 Alternate-site testing.—The agency, in
884 consultation with the Board of Clinical Laboratory Personnel,
885 shall adopt by rule the criteria for alternate-site testing to
886 be performed under the supervision of a clinical laboratory
887 director. At a minimum, the criteria must address hospital
888 internal needs assessment; a protocol for implementation,
889 including the identification of tests to be performed and who
890 will perform them; selection of the method of testing to be used
891 for alternate-site testing; minimum training and education
892 requirements for those who will perform alternate-site testing,
893 such as documented training, licensure, certification, or other
894 medical professional background not limited to laboratory
895 professionals; documented inservice training and initial and
896 ongoing competency validation; an appropriate internal and
897 external quality control protocol; an internal mechanism for the
898 central laboratory to identify and track alternate-site testing;
899 and recordkeeping requirements. Alternate-site testing locations
900 must register when the hospital applies to renew its license.
901 For purposes of this section, the term “alternate-site testing”
902 includes any laboratory testing done under the administrative
903 control of a hospital, but performed out of the physical or
904 administrative confines of the central laboratory.
905 Section 28. Paragraph (f) of subsection (1) of section
906 395.0161, Florida Statutes, is amended to read:
907 395.0161 Licensure inspection.—
908 (1) In addition to the requirement of s. 408.811, the
909 agency shall make or cause to be made such inspections and
910 investigations as it deems necessary, including:
911 (f) Inspections of mobile surgical facilities at each time
912 a facility establishes a new location, prior to the admission of
913 patients. However, such inspections shall not be required when a
914 mobile surgical facility is moved temporarily to a location
915 where medical treatment will not be provided.
916 Section 29. Subsection (3) of section 395.0163, Florida
917 Statutes, is amended to read:
918 395.0163 Construction inspections; plan submission and
919 approval; fees.—
920 (3) In addition to the requirements of s. 408.811, the
921 agency shall inspect a mobile surgical facility at initial
922 licensure and at each time the facility establishes a new
923 location, prior to admission of patients. However, such
924 inspections shall not be required when a mobile surgical
925 facility is moved temporarily to a location where medical
926 treatment will not be provided.
927 Section 30. Subsection (2), paragraph (c) of subsection
928 (6), and subsections (16) and (17) of section 395.0197, Florida
929 Statutes, are amended to read:
930 395.0197 Internal risk management program.—
931 (2) The internal risk management program is the
932 responsibility of the governing board of the health care
933 facility. Each licensed facility shall hire a risk manager,
934 licensed under s. 395.10974, who is responsible for
935 implementation and oversight of the such facility’s internal
936 risk management program and who demonstrates competence, through
937 education or experience, in all of the following areas:
938 (a) Applicable standards of health care risk management.
939 (b) Applicable federal, state, and local health and safety
940 laws and rules.
941 (c) General risk management administration.
942 (d) Patient care.
943 (e) Medical care.
944 (f) Personal and social care.
945 (g) Accident prevention.
946 (h) Departmental organization and management.
947 (i) Community interrelationships.
948 (j) Medical terminology as required by this section. A risk
949 manager must not be made responsible for more than four internal
950 risk management programs in separate licensed facilities, unless
951 the facilities are under one corporate ownership or the risk
952 management programs are in rural hospitals.
953 (6)
954 (c) The report submitted to the agency must shall also
955 contain the name and license number of the risk manager of the
956 licensed facility, a copy of its policy and procedures which
957 govern the measures taken by the facility and its risk manager
958 to reduce the risk of injuries and adverse incidents, and the
959 results of such measures. The annual report is confidential and
960 is not available to the public pursuant to s. 119.07(1) or any
961 other law providing access to public records. The annual report
962 is not discoverable or admissible in any civil or administrative
963 action, except in disciplinary proceedings by the agency or the
964 appropriate regulatory board. The annual report is not available
965 to the public as part of the record of investigation for and
966 prosecution in disciplinary proceedings made available to the
967 public by the agency or the appropriate regulatory board.
968 However, the agency or the appropriate regulatory board shall
969 make available, upon written request by a health care
970 professional against whom probable cause has been found, any
971 such records which form the basis of the determination of
972 probable cause.
973 (16) There shall be no monetary liability on the part of,
974 and no cause of action for damages shall arise against, any risk
975 manager, licensed under s. 395.10974, for the implementation and
976 oversight of the internal risk management program in a facility
977 licensed under this chapter or chapter 390 as required by this
978 section, for any act or proceeding undertaken or performed
979 within the scope of the functions of such internal risk
980 management program if the risk manager acts without intentional
981 fraud.
982 (17) A privilege against civil liability is hereby granted
983 to any licensed risk manager or licensed facility with regard to
984 information furnished pursuant to this chapter, unless the
985 licensed risk manager or facility acted in bad faith or with
986 malice in providing such information.
987 Section 31. Section 395.1046, Florida Statutes, is
988 repealed.
989 Section 32. Present subsection (10) of section 395.1055,
990 Florida Statutes, is redesignated as subsection (12),
991 subsections (2), (3), and (9) of that section are amended,
992 paragraph (i) is added to subsection (1) of that section, and a
993 new subsection (10) and subsection (11) are added to that
994 section, to read:
995 395.1055 Rules and enforcement.—
996 (1) The agency shall adopt rules pursuant to ss. 120.536(1)
997 and 120.54 to implement the provisions of this part, which shall
998 include reasonable and fair minimum standards for ensuring that:
999 (i) All hospitals providing organ transplantation, neonatal
1000 intensive care services, inpatient psychiatric services,
1001 inpatient substance abuse services, or comprehensive medical
1002 rehabilitation meet the minimum licensure requirements adopted
1003 by the agency. Such licensure requirements must include quality
1004 of care, nurse staffing, physician staffing, physical plant,
1005 equipment, emergency transportation, and data reporting
1006 standards.
1007 (2) Separate standards may be provided for general and
1008 specialty hospitals, ambulatory surgical centers, mobile
1009 surgical facilities, and statutory rural hospitals as defined in
1010 s. 395.602.
1011 (3) The agency shall adopt rules with respect to the care
1012 and treatment of patients residing in distinct part nursing
1013 units of hospitals which are certified for participation in
1014 Title XVIII (Medicare) and Title XIX (Medicaid) of the Social
1015 Security Act skilled nursing facility program. Such rules shall
1016 take into account the types of patients treated in hospital
1017 skilled nursing units, including typical patient acuity levels
1018 and the average length of stay in such units, and shall be
1019 limited to the appropriate portions of the Omnibus Budget
1020 Reconciliation Act of 1987 (Pub. L. No. 100-203) (December 22,
1021 1987), Title IV (Medicare, Medicaid, and Other Health-Related
1022 Programs), Subtitle C (Nursing Home Reform), as amended. The
1023 agency shall require level 2 background screening as specified
1024 in s. 408.809(1)(e) pursuant to s. 408.809 and chapter 435 for
1025 personnel of distinct part nursing units.
1026 (9) The agency shall establish a technical advisory panel,
1027 pursuant to s. 20.052, to develop procedures and standards for
1028 measuring outcomes of pediatric cardiac catheterization programs
1029 and pediatric cardiovascular open-heart surgery programs.
1030 (a) Members of the panel must have technical expertise in
1031 pediatric cardiac medicine, shall serve without compensation,
1032 and may not be reimbursed for per diem and travel expenses. be
1033 composed
1034 (b) Voting members of the panel shall include: 3 at-large
1035 members, including 1 cardiologist who is board certified in
1036 caring for adults with congenital heart disease and 2 board
1037 certified pediatric cardiologists, neither of whom may be
1038 employed by any of the hospitals specified in subparagraphs 1.
1039 10. or their affiliates, each of whom is appointed by the
1040 Secretary of Health Care Administration, and 10 members, and an
1041 alternate for each member, each of whom is a pediatric
1042 cardiologist or a pediatric cardiovascular surgeon, each
1043 appointed by the chief executive officer of one of the following
1044 hospitals:
1045 1. Johns Hopkins All Children’s Hospital in St. Petersburg.
1046 2. Arnold Palmer Hospital for Children in Orlando.
1047 3. Joe DiMaggio Children’s Hospital in Hollywood.
1048 4. Nicklaus Children’s Hospital in Miami.
1049 5. St. Joseph’s Children’s Hospital in Tampa.
1050 6. University of Florida Health Shands Hospital in
1051 Gainesville.
1052 7. University of Miami Holtz Children’s Hospital in Miami.
1053 8. Wolfson Children’s Hospital in Jacksonville.
1054 9. Florida Hospital for Children in Orlando.
1055 10. Nemours Children’s Hospital in Orlando.
1056
1057 Appointments made under subparagraphs 1.-10. are contingent upon
1058 the hospital’s maintenance of pediatric certificates of need and
1059 the hospital’s compliance with this section and rules adopted
1060 thereunder, as determined by the Secretary of Health Care
1061 Administration. A member appointed under subparagraphs 1.-10.
1062 whose hospital fails to maintain such certificates or comply
1063 with standards may serve only as a nonvoting member until the
1064 hospital restores such certificates or complies with such
1065 standards.
1066 (c) The Secretary of Health Care Administration may appoint
1067 nonvoting members to the panel. Nonvoting members may include:
1068 1. The Secretary of Health Care Administration.
1069 2. The Surgeon General.
1070 3. The Deputy Secretary of Children’s Medical Services.
1071 4. Any current or past Division Director of Children’s
1072 Medical Services.
1073 5. A parent of a child with congenital heart disease.
1074 6. An adult with congenital heart disease.
1075 7. A representative from each of the following
1076 organizations: the Florida Chapter of the American Academy of
1077 Pediatrics, the Florida Chapter of the American College of
1078 Cardiology, the Greater Southeast Affiliate of the American
1079 Heart Association, the Adult Congenital Heart Association, the
1080 March of Dimes, the Florida Association of Children’s Hospitals,
1081 and the Florida Society of Thoracic and Cardiovascular Surgeons.
1082 (d) The panel shall meet biannually, or more frequently
1083 upon the call of the Secretary of Health Care Administration.
1084 Such meetings may be conducted telephonically, or by other
1085 electronic means.
1086 (e) The duties of the panel include recommending to the
1087 agency standards for quality of care, personnel, physical plant,
1088 equipment, emergency transportation, and data reporting for
1089 hospitals that provide pediatric cardiac services.
1090 (f) Beginning on January 1, 2020, and annually thereafter,
1091 the panel shall submit a report to the Governor, the President
1092 of the Senate, the Speaker of the House of Representatives, the
1093 Secretary of Health Care Administration, and the State Surgeon
1094 General. The report must summarize the panel’s activities during
1095 the preceding fiscal year and include data and performance
1096 measures on surgical morbidity and mortality for all pediatric
1097 cardiac programs.
1098 (b) Based on the recommendations of the panel, the agency
1099 shall develop and adopt rules for pediatric cardiac
1100 catheterization programs and pediatric open-heart surgery
1101 programs which include at least the following:
1102 1. A risk adjustment procedure that accounts for the
1103 variations in severity and case mix found in hospitals in this
1104 state;
1105 2. Outcome standards specifying expected levels of
1106 performance in pediatric cardiac programs. Such standards may
1107 include, but are not limited to, in-hospital mortality,
1108 infection rates, nonfatal myocardial infarctions, length of
1109 postoperative bleeds, and returns to surgery; and
1110 3. Specific steps to be taken by the agency and licensed
1111 facilities that do not meet the outcome standards within a
1112 specified time, including time required for detailed case
1113 reviews and development and implementation of corrective action
1114 plans.
1115 (c) This subsection is repealed on July 1, 2022.
1116 (10) Based on the recommendations of the advisory panel in
1117 subsection (9), the agency shall adopt rules for pediatric
1118 cardiac programs which, at a minimum, include:
1119 (a) Standards for pediatric cardiac catheterization
1120 services and pediatric cardiovascular surgery including quality
1121 of care, personnel, physical plant, equipment, emergency
1122 transportation, data reporting, and appropriate operating hours
1123 and timeframes for mobilization for emergency procedures.
1124 (b) Outcome standards consistent with nationally
1125 established levels of performance in pediatric cardiac programs.
1126 (c) Specific steps to be taken by the agency and licensed
1127 facilities when the facilities do not meet the outcome standards
1128 within a specified time, including time required for detailed
1129 case reviews and the development and implementation of
1130 corrective action plans.
1131 (11) A pediatric cardiac program shall:
1132 (a) Have a pediatric cardiology clinic affiliated with a
1133 hospital licensed under this chapter.
1134 (b) Have a pediatric cardiac catheterization laboratory and
1135 a pediatric cardiovascular surgical program located in the
1136 hospital.
1137 (c) Have a risk adjustment surgical procedure protocol
1138 following the guidelines established by the Society of Thoracic
1139 Surgeons.
1140 (d) Have quality assurance and quality improvement
1141 processes in place to enhance clinical operation and patient
1142 satisfaction with services.
1143 (e) Participate in the clinical outcome reporting systems
1144 operated by the Society of Thoracic Surgeons and the American
1145 College of Cardiology.
1146 (12)(10) The agency may adopt rules to administer the
1147 requirements of part II of chapter 408.
1148 Section 33. Section 395.10971, Florida Statutes, is
1149 repealed.
1150 Section 34. Section 395.10972, Florida Statutes, is
1151 repealed.
1152 Section 35. Section 395.10973, Florida Statutes, is amended
1153 to read:
1154 395.10973 Powers and duties of the agency.—It is the
1155 function of the agency to:
1156 (1) Adopt rules pursuant to ss. 120.536(1) and 120.54 to
1157 implement the provisions of this part and part II of chapter 408
1158 conferring duties upon it.
1159 (2) Develop, impose, and enforce specific standards within
1160 the scope of the general qualifications established by this part
1161 which must be met by individuals in order to receive licenses as
1162 health care risk managers. These standards shall be designed to
1163 ensure that health care risk managers are individuals of good
1164 character and otherwise suitable and, by training or experience
1165 in the field of health care risk management, qualified in
1166 accordance with the provisions of this part to serve as health
1167 care risk managers, within statutory requirements.
1168 (3) Develop a method for determining whether an individual
1169 meets the standards set forth in s. 395.10974.
1170 (4) Issue licenses to qualified individuals meeting the
1171 standards set forth in s. 395.10974.
1172 (5) Receive, investigate, and take appropriate action with
1173 respect to any charge or complaint filed with the agency to the
1174 effect that a certified health care risk manager has failed to
1175 comply with the requirements or standards adopted by rule by the
1176 agency or to comply with the provisions of this part.
1177 (6) Establish procedures for providing periodic reports on
1178 persons certified or disciplined by the agency under this part.
1179 (2)(7) Develop a model risk management program for health
1180 care facilities which will satisfy the requirements of s.
1181 395.0197.
1182 (3)(8) Enforce the special-occupancy provisions of the
1183 Florida Building Code which apply to hospitals, intermediate
1184 residential treatment facilities, and ambulatory surgical
1185 centers in conducting any inspection authorized by this chapter
1186 and part II of chapter 408.
1187 Section 36. Section 395.10974, Florida Statutes, is
1188 repealed.
1189 Section 37. Section 395.10975, Florida Statutes, is
1190 repealed.
1191 Section 38. Subsection (2) of section 395.602, Florida
1192 Statutes, is amended to read:
1193 395.602 Rural hospitals.—
1194 (2) DEFINITIONS.—As used in this part, the term:
1195 (a) “Emergency care hospital” means a medical facility
1196 which provides:
1197 1. Emergency medical treatment; and
1198 2. Inpatient care to ill or injured persons prior to their
1199 transportation to another hospital or provides inpatient medical
1200 care to persons needing care for a period of up to 96 hours. The
1201 96-hour limitation on inpatient care does not apply to respite,
1202 skilled nursing, hospice, or other nonacute care patients.
1203 (b) “Essential access community hospital” means any
1204 facility which:
1205 1. Has at least 100 beds;
1206 2. Is located more than 35 miles from any other essential
1207 access community hospital, rural referral center, or urban
1208 hospital meeting criteria for classification as a regional
1209 referral center;
1210 3. Is part of a network that includes rural primary care
1211 hospitals;
1212 4. Provides emergency and medical backup services to rural
1213 primary care hospitals in its rural health network;
1214 5. Extends staff privileges to rural primary care hospital
1215 physicians in its network; and
1216 6. Accepts patients transferred from rural primary care
1217 hospitals in its network.
1218 (c) “Inactive rural hospital bed” means a licensed acute
1219 care hospital bed, as defined in s. 395.002(13), that is
1220 inactive in that it cannot be occupied by acute care inpatients.
1221 (a)(d) “Rural area health education center” means an area
1222 health education center (AHEC), as authorized by Pub. L. No. 94
1223 484, which provides services in a county with a population
1224 density of up to no greater than 100 persons per square mile.
1225 (b)(e) “Rural hospital” means an acute care hospital
1226 licensed under this chapter, having 100 or fewer licensed beds
1227 and an emergency room, which is:
1228 1. The sole provider within a county with a population
1229 density of up to 100 persons per square mile;
1230 2. An acute care hospital, in a county with a population
1231 density of up to 100 persons per square mile, which is at least
1232 30 minutes of travel time, on normally traveled roads under
1233 normal traffic conditions, from any other acute care hospital
1234 within the same county;
1235 3. A hospital supported by a tax district or subdistrict
1236 whose boundaries encompass a population of up to 100 persons per
1237 square mile;
1238 4. A hospital classified as a sole community hospital under
1239 42 C.F.R. s. 412.92, regardless of the number of licensed beds;
1240 5. A hospital with a service area that has a population of
1241 up to 100 persons per square mile. As used in this subparagraph,
1242 the term “service area” means the fewest number of zip codes
1243 that account for 75 percent of the hospital’s discharges for the
1244 most recent 5-year period, based on information available from
1245 the hospital inpatient discharge database in the Florida Center
1246 for Health Information and Transparency at the agency; or
1247 6. A hospital designated as a critical access hospital, as
1248 defined in s. 408.07.
1249
1250 Population densities used in this paragraph must be based upon
1251 the most recently completed United States census. A hospital
1252 that received funds under s. 409.9116 for a quarter beginning no
1253 later than July 1, 2002, is deemed to have been and shall
1254 continue to be a rural hospital from that date through June 30,
1255 2021, if the hospital continues to have up to 100 licensed beds
1256 and an emergency room. An acute care hospital that has not
1257 previously been designated as a rural hospital and that meets
1258 the criteria of this paragraph shall be granted such designation
1259 upon application, including supporting documentation, to the
1260 agency. A hospital that was licensed as a rural hospital during
1261 the 2010-2011 or 2011-2012 fiscal year shall continue to be a
1262 rural hospital from the date of designation through June 30,
1263 2021, if the hospital continues to have up to 100 licensed beds
1264 and an emergency room.
1265 (f) “Rural primary care hospital” means any facility
1266 meeting the criteria in paragraph (e) or s. 395.605 which
1267 provides:
1268 1. Twenty-four-hour emergency medical care;
1269 2. Temporary inpatient care for periods of 72 hours or less
1270 to patients requiring stabilization before discharge or transfer
1271 to another hospital. The 72-hour limitation does not apply to
1272 respite, skilled nursing, hospice, or other nonacute care
1273 patients; and
1274 3. Has no more than six licensed acute care inpatient beds.
1275 (c)(g) “Swing-bed” means a bed which can be used
1276 interchangeably as either a hospital, skilled nursing facility
1277 (SNF), or intermediate care facility (ICF) bed pursuant to 42
1278 C.F.R. parts 405, 435, 440, 442, and 447.
1279 Section 39. Section 395.603, Florida Statutes, is amended
1280 to read:
1281 395.603 Deactivation of general hospital beds; Rural
1282 hospital impact statement.—
1283 (1) The agency shall establish, by rule, a process by which
1284 a rural hospital, as defined in s. 395.602, that seeks licensure
1285 as a rural primary care hospital or as an emergency care
1286 hospital, or becomes a certified rural health clinic as defined
1287 in Pub. L. No. 95-210, or becomes a primary care program such as
1288 a county health department, community health center, or other
1289 similar outpatient program that provides preventive and curative
1290 services, may deactivate general hospital beds. Rural primary
1291 care hospitals and emergency care hospitals shall maintain the
1292 number of actively licensed general hospital beds necessary for
1293 the facility to be certified for Medicare reimbursement.
1294 Hospitals that discontinue inpatient care to become rural health
1295 care clinics or primary care programs shall deactivate all
1296 licensed general hospital beds. All hospitals, clinics, and
1297 programs with inactive beds shall provide 24-hour emergency
1298 medical care by staffing an emergency room. Providers with
1299 inactive beds shall be subject to the criteria in s. 395.1041.
1300 The agency shall specify in rule requirements for making 24-hour
1301 emergency care available. Inactive general hospital beds shall
1302 be included in the acute care bed inventory, maintained by the
1303 agency for certificate-of-need purposes, for 10 years from the
1304 date of deactivation of the beds. After 10 years have elapsed,
1305 inactive beds shall be excluded from the inventory. The agency
1306 shall, at the request of the licensee, reactivate the inactive
1307 general beds upon a showing by the licensee that licensure
1308 requirements for the inactive general beds are met.
1309 (2) In formulating and implementing policies and rules that
1310 may have significant impact on the ability of rural hospitals to
1311 continue to provide health care services in rural communities,
1312 the agency, the department, or the respective regulatory board
1313 adopting policies or rules regarding the licensure or
1314 certification of health care professionals shall provide a rural
1315 hospital impact statement. The rural hospital impact statement
1316 shall assess the proposed action in light of the following
1317 questions:
1318 (1)(a) Do the health personnel affected by the proposed
1319 action currently practice in rural hospitals or are they likely
1320 to in the near future?
1321 (2)(b) What are the current numbers of the affected health
1322 personnel in this state, their geographic distribution, and the
1323 number practicing in rural hospitals?
1324 (3)(c) What are the functions presently performed by the
1325 affected health personnel, and are such functions presently
1326 performed in rural hospitals?
1327 (4)(d) What impact will the proposed action have on the
1328 ability of rural hospitals to recruit the affected personnel to
1329 practice in their facilities?
1330 (5)(e) What impact will the proposed action have on the
1331 limited financial resources of rural hospitals through increased
1332 salaries and benefits necessary to recruit or retain such health
1333 personnel?
1334 (6)(f) Is there a less stringent requirement which could
1335 apply to practice in rural hospitals?
1336 (7)(g) Will this action create staffing shortages, which
1337 could result in a loss to the public of health care services in
1338 rural hospitals or result in closure of any rural hospitals?
1339 Section 40. Section 395.604, Florida Statutes, is repealed.
1340 Section 41. Section 395.605, Florida Statutes, is repealed.
1341 Section 42. Paragraph (c) of subsection (1) of section
1342 395.701, Florida Statutes, is amended to read:
1343 395.701 Annual assessments on net operating revenues for
1344 inpatient and outpatient services to fund public medical
1345 assistance; administrative fines for failure to pay assessments
1346 when due; exemption.—
1347 (1) For the purposes of this section, the term:
1348 (c) “Hospital” means a health care institution as defined
1349 in s. 395.002(12), but does not include any hospital operated by
1350 a state the agency or the Department of Corrections.
1351 Section 43. Paragraph (b) of subsection (2) of section
1352 395.7015, Florida Statutes, is amended to read:
1353 395.7015 Annual assessment on health care entities.—
1354 (2) There is imposed an annual assessment against certain
1355 health care entities as described in this section:
1356 (b) For the purpose of this section, “health care entities”
1357 include the following:
1358 1. Ambulatory surgical centers and mobile surgical
1359 facilities licensed under s. 395.003. This subsection shall only
1360 apply to mobile surgical facilities operating under contracts
1361 entered into on or after July 1, 1998.
1362 2. Clinical laboratories licensed under s. 483.091,
1363 excluding any hospital laboratory defined under s. 483.041(6),
1364 any clinical laboratory operated by the state or a political
1365 subdivision of the state, any clinical laboratory which
1366 qualifies as an exempt organization under s. 501(c)(3) of the
1367 Internal Revenue Code of 1986, as amended, and which receives 70
1368 percent or more of its gross revenues from services to charity
1369 patients or Medicaid patients, and any blood, plasma, or tissue
1370 bank procuring, storing, or distributing blood, plasma, or
1371 tissue either for future manufacture or research or distributed
1372 on a nonprofit basis, and further excluding any clinical
1373 laboratory which is wholly owned and operated by 6 or fewer
1374 physicians who are licensed pursuant to chapter 458 or chapter
1375 459 and who practice in the same group practice, and at which no
1376 clinical laboratory work is performed for patients referred by
1377 any health care provider who is not a member of the same group.
1378 2.3. Diagnostic-imaging centers that are freestanding
1379 outpatient facilities that provide specialized services for the
1380 identification or determination of a disease through examination
1381 and also provide sophisticated radiological services, and in
1382 which services are rendered by a physician licensed by the Board
1383 of Medicine under s. 458.311, s. 458.313, or s. 458.317, or by
1384 an osteopathic physician licensed by the Board of Osteopathic
1385 Medicine under s. 459.0055 or s. 459.0075. For purposes of this
1386 paragraph, “sophisticated radiological services” means the
1387 following: magnetic resonance imaging; nuclear medicine;
1388 angiography; arteriography; computed tomography; positron
1389 emission tomography; digital vascular imaging; bronchography;
1390 lymphangiography; splenography; ultrasound, excluding ultrasound
1391 providers that are part of a private physician’s office practice
1392 or when ultrasound is provided by two or more physicians
1393 licensed under chapter 458 or chapter 459 who are members of the
1394 same professional association and who practice in the same
1395 medical specialties; and such other sophisticated radiological
1396 services, excluding mammography, as adopted in rule by the
1397 board.
1398 Section 44. Subsection (1) of section 400.0625, Florida
1399 Statutes, is amended to read:
1400 400.0625 Minimum standards for clinical laboratory test
1401 results and diagnostic X-ray results.—
1402 (1) Each nursing home, as a requirement for issuance or
1403 renewal of its license, shall require that all clinical
1404 laboratory tests performed for the nursing home be performed by
1405 a clinical laboratory appropriately certified by the Centers for
1406 Medicare and Medicaid Services under the federal Clinical
1407 Laboratory Improvement Amendments and the federal rules adopted
1408 thereunder licensed under the provisions of chapter 483, except
1409 for such self-testing procedures as are approved by the agency
1410 by rule. Results of clinical laboratory tests performed prior to
1411 admission which meet the minimum standards provided in s.
1412 483.181(3) shall be accepted in lieu of routine examinations
1413 required upon admission and clinical laboratory tests which may
1414 be ordered by a physician for residents of the nursing home.
1415 Section 45. Paragraph (a) of subsection (2) of section
1416 400.191, Florida Statutes, is amended to read:
1417 400.191 Availability, distribution, and posting of reports
1418 and records.—
1419 (2) The agency shall publish the Nursing Home Guide
1420 quarterly in electronic form to assist consumers and their
1421 families in comparing and evaluating nursing home facilities.
1422 (a) The agency shall provide an Internet site which shall
1423 include at least the following information either directly or
1424 indirectly through a link to another established site or sites
1425 of the agency’s choosing:
1426 1. A section entitled “Have you considered programs that
1427 provide alternatives to nursing home care?” which shall be the
1428 first section of the Nursing Home Guide and which shall
1429 prominently display information about available alternatives to
1430 nursing homes and how to obtain additional information regarding
1431 these alternatives. The Nursing Home Guide shall explain that
1432 this state offers alternative programs that permit qualified
1433 elderly persons to stay in their homes instead of being placed
1434 in nursing homes and shall encourage interested persons to call
1435 the Comprehensive Assessment Review and Evaluation for Long-Term
1436 Care Services (CARES) Program to inquire if they qualify. The
1437 Nursing Home Guide shall list available home and community-based
1438 programs which shall clearly state the services that are
1439 provided and indicate whether nursing home services are included
1440 if needed.
1441 2. A list by name and address of all nursing home
1442 facilities in this state, including any prior name by which a
1443 facility was known during the previous 24-month period.
1444 3. Whether such nursing home facilities are proprietary or
1445 nonproprietary.
1446 4. The current owner of the facility’s license and the year
1447 that that entity became the owner of the license.
1448 5. The name of the owner or owners of each facility and
1449 whether the facility is affiliated with a company or other
1450 organization owning or managing more than one nursing facility
1451 in this state.
1452 6. The total number of beds in each facility and the most
1453 recently available occupancy levels.
1454 7. The number of private and semiprivate rooms in each
1455 facility.
1456 8. The religious affiliation, if any, of each facility.
1457 9. The languages spoken by the administrator and staff of
1458 each facility.
1459 10. Whether or not each facility accepts Medicare or
1460 Medicaid recipients or insurance, health maintenance
1461 organization, Veterans Administration, CHAMPUS program, or
1462 workers’ compensation coverage.
1463 11. Recreational and other programs available at each
1464 facility.
1465 12. Special care units or programs offered at each
1466 facility.
1467 13. Whether the facility is a part of a retirement
1468 community that offers other services pursuant to part III of
1469 this chapter or part I or part III of chapter 429.
1470 14. Survey and deficiency information, including all
1471 federal and state recertification, licensure, revisit, and
1472 complaint survey information, for each facility for the past 30
1473 months. For noncertified nursing homes, state survey and
1474 deficiency information, including licensure, revisit, and
1475 complaint survey information for the past 30 months shall be
1476 provided.
1477 Section 46. Subsection (1) and paragraphs (b), (e), and (f)
1478 of subsection (4) of section 400.464, Florida Statutes, are
1479 amended, and subsection (6) is added to that section, to read:
1480 400.464 Home health agencies to be licensed; expiration of
1481 license; exemptions; unlawful acts; penalties.—
1482 (1) The requirements of part II of chapter 408 apply to the
1483 provision of services that require licensure pursuant to this
1484 part and part II of chapter 408 and entities licensed or
1485 registered by or applying for such licensure or registration
1486 from the Agency for Health Care Administration pursuant to this
1487 part. A license issued by the agency is required in order to
1488 operate a home health agency in this state. A license issued on
1489 or after July 1, 2018, must specify the home health services the
1490 organization is authorized to perform and indicate whether such
1491 specified services are considered skilled care. The provision or
1492 advertising of services that require licensure pursuant to this
1493 part without such services being specified on the face of the
1494 license issued on or after July 1, 2018, constitutes unlicensed
1495 activity as prohibited under s. 408.812.
1496 (4)
1497 (b) The operation or maintenance of an unlicensed home
1498 health agency or the performance of any home health services in
1499 violation of this part is declared a nuisance, inimical to the
1500 public health, welfare, and safety. The agency or any state
1501 attorney may, in addition to other remedies provided in this
1502 part, bring an action for an injunction to restrain such
1503 violation, or to enjoin the future operation or maintenance of
1504 the home health agency or the provision of home health services
1505 in violation of this part or part II of chapter 408, until
1506 compliance with this part or the rules adopted under this part
1507 has been demonstrated to the satisfaction of the agency.
1508 (e) Any person who owns, operates, or maintains an
1509 unlicensed home health agency and who, within 10 working days
1510 after receiving notification from the agency, fails to cease
1511 operation and apply for a license under this part commits a
1512 misdemeanor of the second degree, punishable as provided in s.
1513 775.082 or s. 775.083. Each day of continued operation is a
1514 separate offense.
1515 (f) Any home health agency that fails to cease operation
1516 after agency notification may be fined in accordance with s.
1517 408.812 $500 for each day of noncompliance.
1518 (6) Any person, entity, or organization providing home
1519 health services which is exempt from licensure under subsection
1520 (5) may voluntarily apply for a certificate of exemption from
1521 licensure under its exempt status with the agency on a form that
1522 specifies its name or names and addresses, a statement of the
1523 reasons why it is exempt from licensure as a home health agency,
1524 and other information deemed necessary by the agency. A
1525 certificate of exemption is valid for a period of not more than
1526 2 years and is not transferable. The agency may charge an
1527 applicant $100 for a certificate of exemption or charge the
1528 actual cost of processing the certificate.
1529 Section 47. Subsections (6) through (9) of section 400.471,
1530 Florida Statutes, are redesignated as subsections (5) through
1531 (8), respectively, and present subsections (2),(6), and (9) of
1532 that section are amended, to read:
1533 400.471 Application for license; fee.—
1534 (2) In addition to the requirements of part II of chapter
1535 408, the initial applicant, the applicant for a change of
1536 ownership, and the applicant for the addition of skilled care
1537 services must file with the application satisfactory proof that
1538 the home health agency is in compliance with this part and
1539 applicable rules, including:
1540 (a) A listing of services to be provided, either directly
1541 by the applicant or through contractual arrangements with
1542 existing providers.
1543 (b) The number and discipline of professional staff to be
1544 employed.
1545 (c) Completion of questions concerning volume data on the
1546 renewal application as determined by rule.
1547 (c)(d) A business plan, signed by the applicant, which
1548 details the home health agency’s methods to obtain patients and
1549 its plan to recruit and maintain staff.
1550 (d)(e) Evidence of contingency funding as required under s.
1551 408.8065 equal to 1 month’s average operating expenses during
1552 the first year of operation.
1553 (e)(f) A balance sheet, income and expense statement, and
1554 statement of cash flows for the first 2 years of operation which
1555 provide evidence of having sufficient assets, credit, and
1556 projected revenues to cover liabilities and expenses. The
1557 applicant has demonstrated financial ability to operate if the
1558 applicant’s assets, credit, and projected revenues meet or
1559 exceed projected liabilities and expenses. An applicant may not
1560 project an operating margin of 15 percent or greater for any
1561 month in the first year of operation. All documents required
1562 under this paragraph must be prepared in accordance with
1563 generally accepted accounting principles and compiled and signed
1564 by a certified public accountant.
1565 (f)(g) All other ownership interests in health care
1566 entities for each controlling interest, as defined in part II of
1567 chapter 408.
1568 (g)(h) In the case of an application for initial licensure,
1569 an application for a change of ownership, or an application for
1570 the addition of skilled care services, documentation of
1571 accreditation, or an application for accreditation, from an
1572 accrediting organization that is recognized by the agency as
1573 having standards comparable to those required by this part and
1574 part II of chapter 408. A home health agency that is not
1575 Medicare or Medicaid certified and does not provide skilled care
1576 is exempt from this paragraph. Notwithstanding s. 408.806, an
1577 initial applicant that has applied for accreditation must
1578 provide proof of accreditation that is not conditional or
1579 provisional and a survey demonstrating compliance with the
1580 requirements of this part, part II of chapter 408, and
1581 applicable rules from an accrediting organization that is
1582 recognized by the agency as having standards comparable to those
1583 required by this part and part II of chapter 408 within 120 days
1584 after the date of the agency’s receipt of the application for
1585 licensure or the application shall be withdrawn from further
1586 consideration. Such accreditation must be continuously
1587 maintained by the home health agency to maintain licensure. The
1588 agency shall accept, in lieu of its own periodic licensure
1589 survey, the submission of the survey of an accrediting
1590 organization that is recognized by the agency if the
1591 accreditation of the licensed home health agency is not
1592 provisional and if the licensed home health agency authorizes
1593 releases of, and the agency receives the report of, the
1594 accrediting organization.
1595 (6) The agency may not issue a license designated as
1596 certified to a home health agency that fails to satisfy the
1597 requirements of a Medicare certification survey from the agency.
1598 (8)(9) The agency may not issue a renewal license for a
1599 home health agency in any county having at least one licensed
1600 home health agency and that has more than one home health agency
1601 per 5,000 persons, as indicated by the most recent population
1602 estimates published by the Legislature’s Office of Economic and
1603 Demographic Research, if the applicant or any controlling
1604 interest has been administratively sanctioned by the agency
1605 during the 2 years prior to the submission of the licensure
1606 renewal application for one or more of the following acts:
1607 (a) An intentional or negligent act that materially affects
1608 the health or safety of a client of the provider;
1609 (b) Knowingly providing home health services in an
1610 unlicensed assisted living facility or unlicensed adult family
1611 care home, unless the home health agency or employee reports the
1612 unlicensed facility or home to the agency within 72 hours after
1613 providing the services;
1614 (c) Preparing or maintaining fraudulent patient records,
1615 such as, but not limited to, charting ahead, recording vital
1616 signs or symptoms which were not personally obtained or observed
1617 by the home health agency’s staff at the time indicated,
1618 borrowing patients or patient records from other home health
1619 agencies to pass a survey or inspection, or falsifying
1620 signatures;
1621 (d) Failing to provide at least one service directly to a
1622 patient for a period of 60 days;
1623 (e) Demonstrating a pattern of falsifying documents
1624 relating to the training of home health aides or certified
1625 nursing assistants or demonstrating a pattern of falsifying
1626 health statements for staff who provide direct care to patients.
1627 A pattern may be demonstrated by a showing of at least three
1628 fraudulent entries or documents;
1629 (f) Demonstrating a pattern of billing any payor for
1630 services not provided. A pattern may be demonstrated by a
1631 showing of at least three billings for services not provided
1632 within a 12-month period;
1633 (g) Demonstrating a pattern of failing to provide a service
1634 specified in the home health agency’s written agreement with a
1635 patient or the patient’s legal representative, or the plan of
1636 care for that patient, except unless a reduction in service is
1637 mandated by Medicare, Medicaid, or a state program or as
1638 provided in s. 400.492(3). A pattern may be demonstrated by a
1639 showing of at least three incidents, regardless of the patient
1640 or service, in which the home health agency did not provide a
1641 service specified in a written agreement or plan of care during
1642 a 3-month period;
1643 (h) Giving remuneration to a case manager, discharge
1644 planner, facility-based staff member, or third-party vendor who
1645 is involved in the discharge planning process of a facility
1646 licensed under chapter 395, chapter 429, or this chapter from
1647 whom the home health agency receives referrals or gives
1648 remuneration as prohibited in s. 400.474(6)(a);
1649 (i) Giving cash, or its equivalent, to a Medicare or
1650 Medicaid beneficiary;
1651 (j) Demonstrating a pattern of billing the Medicaid program
1652 for services to Medicaid recipients which are medically
1653 unnecessary as determined by a final order. A pattern may be
1654 demonstrated by a showing of at least two such medically
1655 unnecessary services within one Medicaid program integrity audit
1656 period;
1657 (k) Providing services to residents in an assisted living
1658 facility for which the home health agency does not receive fair
1659 market value remuneration; or
1660 (l) Providing staffing to an assisted living facility for
1661 which the home health agency does not receive fair market value
1662 remuneration.
1663 Section 48. Subsection (5) of section 400.474, Florida
1664 Statutes, is amended to read:
1665 400.474 Administrative penalties.—
1666 (5) The agency shall impose a fine of $5,000 against a home
1667 health agency that demonstrates a pattern of failing to provide
1668 a service specified in the home health agency’s written
1669 agreement with a patient or the patient’s legal representative,
1670 or the plan of care for that patient, except unless a reduction
1671 in service is mandated by Medicare, Medicaid, or a state program
1672 or as provided in s. 400.492(3). A pattern may be demonstrated
1673 by a showing of at least three incidences, regardless of the
1674 patient or service, where the home health agency did not provide
1675 a service specified in a written agreement or plan of care
1676 during a 3-month period. The agency shall impose the fine for
1677 each occurrence. The agency may also impose additional
1678 administrative fines under s. 400.484 for the direct or indirect
1679 harm to a patient, or deny, revoke, or suspend the license of
1680 the home health agency for a pattern of failing to provide a
1681 service specified in the home health agency’s written agreement
1682 with a patient or the plan of care for that patient.
1683 Section 49. Paragraph (c) of subsection (2) of section
1684 400.476, Florida Statutes, is amended to read:
1685 400.476 Staffing requirements; notifications; limitations
1686 on staffing services.—
1687 (2) DIRECTOR OF NURSING.—
1688 (c) A home health agency that provides skilled nursing care
1689 must is not Medicare or Medicaid certified and does not provide
1690 skilled care or provides only physical, occupational, or speech
1691 therapy is not required to have a director of nursing and is
1692 exempt from paragraph (b).
1693 Section 50. Section 400.484, Florida Statutes, is amended
1694 to read:
1695 400.484 Right of inspection; violations deficiencies;
1696 fines.—
1697 (1) In addition to the requirements of s. 408.811, the
1698 agency may make such inspections and investigations as are
1699 necessary in order to determine the state of compliance with
1700 this part, part II of chapter 408, and applicable rules.
1701 (2) The agency shall impose fines for various classes of
1702 violations deficiencies in accordance with the following
1703 schedule:
1704 (a) Class I violations are as provided in s. 408.813 A
1705 class I deficiency is any act, omission, or practice that
1706 results in a patient’s death, disablement, or permanent injury,
1707 or places a patient at imminent risk of death, disablement, or
1708 permanent injury. Upon finding a class I violation deficiency,
1709 the agency shall impose an administrative fine in the amount of
1710 $15,000 for each occurrence and each day that the violation
1711 deficiency exists.
1712 (b) Class II violations are as provided in s. 408.813 A
1713 class II deficiency is any act, omission, or practice that has a
1714 direct adverse effect on the health, safety, or security of a
1715 patient. Upon finding a class II violation deficiency, the
1716 agency shall impose an administrative fine in the amount of
1717 $5,000 for each occurrence and each day that the violation
1718 deficiency exists.
1719 (c) Class III violations are as provided in s. 408.813 A
1720 class III deficiency is any act, omission, or practice that has
1721 an indirect, adverse effect on the health, safety, or security
1722 of a patient. Upon finding an uncorrected or repeated class III
1723 violation deficiency, the agency shall impose an administrative
1724 fine not to exceed $1,000 for each occurrence and each day that
1725 the uncorrected or repeated violation deficiency exists.
1726 (d) Class IV violations are as provided in s. 408.813 A
1727 class IV deficiency is any act, omission, or practice related to
1728 required reports, forms, or documents which does not have the
1729 potential of negatively affecting patients. These violations are
1730 of a type that the agency determines do not threaten the health,
1731 safety, or security of patients. Upon finding an uncorrected or
1732 repeated class IV violation deficiency, the agency shall impose
1733 an administrative fine not to exceed $500 for each occurrence
1734 and each day that the uncorrected or repeated violation
1735 deficiency exists.
1736 (3) In addition to any other penalties imposed pursuant to
1737 this section or part, the agency may assess costs related to an
1738 investigation that results in a successful prosecution,
1739 excluding costs associated with an attorney’s time.
1740 Section 51. Subsection (4) of section 400.497, Florida
1741 Statutes, is amended to read:
1742 400.497 Rules establishing minimum standards.—The agency
1743 shall adopt, publish, and enforce rules to implement part II of
1744 chapter 408 and this part, including, as applicable, ss. 400.506
1745 and 400.509, which must provide reasonable and fair minimum
1746 standards relating to:
1747 (4) Licensure application and renewal and certificates of
1748 exemption.
1749 Section 52. Subsection (5), paragraphs (d) and (e) of
1750 subsection (6), paragraph (a) of subsection (15), and subsection
1751 (19) of section 400.506, Florida Statutes, are amended to read:
1752 400.506 Licensure of nurse registries; requirements;
1753 penalties.—
1754 (5)(a) In addition to the requirements of s. 408.812, any
1755 person who owns, operates, or maintains an unlicensed nurse
1756 registry and who, within 10 working days after receiving
1757 notification from the agency, fails to cease operation and apply
1758 for a license under this part commits a misdemeanor of the
1759 second degree, punishable as provided in s. 775.082 or s.
1760 775.083. Each day of continued operation is a separate offense.
1761 (b) If a nurse registry fails to cease operation after
1762 agency notification, the agency may impose a fine pursuant to s.
1763 408.812 of $500 for each day of noncompliance.
1764 (6)
1765 (d) A registered nurse, licensed practical nurse, certified
1766 nursing assistant, companion or homemaker, or home health aide
1767 referred for contract under this chapter by a nurse registry is
1768 deemed an independent contractor and not an employee of the
1769 nurse registry under any chapter regardless of the obligations
1770 imposed on a nurse registry under this chapter or chapter 408.
1771 (e) Upon referral of a registered nurse, licensed practical
1772 nurse, certified nursing assistant, companion or homemaker, or
1773 home health aide for contract in a private residence or
1774 facility, the nurse registry shall advise the patient, the
1775 patient’s family, or any other person acting on behalf of the
1776 patient, at the time of the contract for services, that the
1777 caregiver referred by the nurse registry is an independent
1778 contractor and that the it is not the obligation of a nurse
1779 registry may not to monitor, supervise, manage, or train a
1780 caregiver referred for contract under this chapter.
1781 (15)(a) The agency may deny, suspend, or revoke the license
1782 of a nurse registry and shall impose a fine of $5,000 against a
1783 nurse registry that:
1784 1. Provides services to residents in an assisted living
1785 facility for which the nurse registry does not receive fair
1786 market value remuneration.
1787 2. Provides staffing to an assisted living facility for
1788 which the nurse registry does not receive fair market value
1789 remuneration.
1790 3. Fails to provide the agency, upon request, with copies
1791 of all contracts with assisted living facilities which were
1792 executed within the last 5 years.
1793 4. Gives remuneration to a case manager, discharge planner,
1794 facility-based staff member, or third-party vendor who is
1795 involved in the discharge planning process of a facility
1796 licensed under chapter 395 or this chapter and from whom the
1797 nurse registry receives referrals. A nurse registry is exempt
1798 from this subparagraph if it does not bill the Florida Medicaid
1799 program or the Medicare program or share a controlling interest
1800 with any entity licensed, registered, or certified under part II
1801 of chapter 408 that bills the Florida Medicaid program or the
1802 Medicare program.
1803 5. Gives remuneration to a physician, a member of the
1804 physician’s office staff, or an immediate family member of the
1805 physician, and the nurse registry received a patient referral in
1806 the last 12 months from that physician or the physician’s office
1807 staff. A nurse registry is exempt from this subparagraph if it
1808 does not bill the Florida Medicaid program or the Medicare
1809 program or share a controlling interest with any entity
1810 licensed, registered, or certified under part II of chapter 408
1811 that bills the Florida Medicaid program or the Medicare program.
1812 (19) It is not the obligation of A nurse registry may not
1813 to monitor, supervise, manage, or train a registered nurse,
1814 licensed practical nurse, certified nursing assistant, companion
1815 or homemaker, or home health aide referred for contract under
1816 this chapter. In the event of a violation of this chapter or a
1817 violation of any other law of this state by a referred
1818 registered nurse, licensed practical nurse, certified nursing
1819 assistant, companion or homemaker, or home health aide, or a
1820 deficiency in credentials which comes to the attention of the
1821 nurse registry, the nurse registry shall advise the patient to
1822 terminate the referred person’s contract, providing the reason
1823 for the suggested termination; cease referring the person to
1824 other patients or facilities; and, if practice violations are
1825 involved, notify the licensing board. This section does not
1826 affect or negate any other obligations imposed on a nurse
1827 registry under chapter 408.
1828 Section 53. Subsection (1) of section 400.606, Florida
1829 Statutes, is amended to read:
1830 400.606 License; application; renewal; conditional license
1831 or permit; certificate of need.—
1832 (1) In addition to the requirements of part II of chapter
1833 408, the initial application and change of ownership application
1834 must be accompanied by a plan for the delivery of home,
1835 residential, and homelike inpatient hospice services to
1836 terminally ill persons and their families. Such plan must
1837 contain, but need not be limited to:
1838 (a) The estimated average number of terminally ill persons
1839 to be served monthly.
1840 (b) The geographic area in which hospice services will be
1841 available.
1842 (c) A listing of services which are or will be provided,
1843 either directly by the applicant or through contractual
1844 arrangements with existing providers.
1845 (d) Provisions for the implementation of hospice home care
1846 within 3 months after licensure.
1847 (e) Provisions for the implementation of hospice homelike
1848 inpatient care within 12 months after licensure.
1849 (f) The number and disciplines of professional staff to be
1850 employed.
1851 (g) The name and qualifications of any existing or
1852 potential contractee.
1853 (h) A plan for attracting and training volunteers.
1854
1855 If the applicant is an existing licensed health care provider,
1856 the application must be accompanied by a copy of the most recent
1857 profit-loss statement and, if applicable, the most recent
1858 licensure inspection report.
1859 Section 54. Subsection (6) of section 400.925, Florida
1860 Statutes, is amended to read:
1861 400.925 Definitions.—As used in this part, the term:
1862 (6) “Home medical equipment” includes any product as
1863 defined by the Food and Drug Administration’s Federal Food,
1864 Drug, and Cosmetic Act, any products reimbursed under the
1865 Medicare Part B Durable Medical Equipment benefits, or any
1866 products reimbursed under the Florida Medicaid durable medical
1867 equipment program. Home medical equipment includes:
1868 (a) Oxygen and related respiratory equipment; manual,
1869 motorized, or customized wheelchairs and related seating and
1870 positioning, but does not include prosthetics or orthotics or
1871 any splints, braces, or aids custom fabricated by a licensed
1872 health care practitioner;
1873 (b) Motorized scooters;
1874 (c) Personal transfer systems; and
1875 (d) Specialty beds, for use by a person with a medical
1876 need; and
1877 (e) Manual, motorized, or customized wheelchairs and
1878 related seating and positioning, but does not include
1879 prosthetics or orthotics or any splints, braces, or aids custom
1880 fabricated by a licensed health care practitioner.
1881 Section 55. Subsection (4) of section 400.931, Florida
1882 Statutes, is amended to read:
1883 400.931 Application for license; fee.—
1884 (4) When a change of the general manager of a home medical
1885 equipment provider occurs, the licensee must notify the agency
1886 of the change within the timeframes established in part II of
1887 chapter 408 and applicable rules 45 days.
1888 Section 56. Subsection (2) of section 400.933, Florida
1889 Statutes, is amended to read:
1890 400.933 Licensure inspections and investigations.—
1891 (2) The agency shall accept, in lieu of its own periodic
1892 inspections for licensure, submission of the following:
1893 (a) The survey or inspection of an accrediting
1894 organization, provided the accreditation of the licensed home
1895 medical equipment provider is not provisional and provided the
1896 licensed home medical equipment provider authorizes release of,
1897 and the agency receives the report of, the accrediting
1898 organization; or
1899 (b) A copy of a valid medical oxygen retail establishment
1900 permit issued by the Department of Business and Professional
1901 Regulation Health, pursuant to chapter 499.
1902 Section 57. Subsection (2) of section 400.980, Florida
1903 Statutes, is amended to read:
1904 400.980 Health care services pools.—
1905 (2) The requirements of part II of chapter 408 apply to the
1906 provision of services that require licensure or registration
1907 pursuant to this part and part II of chapter 408 and to entities
1908 registered by or applying for such registration from the agency
1909 pursuant to this part. Registration or a license issued by the
1910 agency is required for the operation of a health care services
1911 pool in this state. In accordance with s. 408.805, an applicant
1912 or licensee shall pay a fee for each license application
1913 submitted using this part, part II of chapter 408, and
1914 applicable rules. The agency shall adopt rules and provide forms
1915 required for such registration and shall impose a registration
1916 fee in an amount sufficient to cover the cost of administering
1917 this part and part II of chapter 408. In addition to the
1918 requirements in part II of chapter 408, the registrant must
1919 provide the agency with any change of information contained on
1920 the original registration application within the timeframes
1921 established in this part, part II of chapter 408, and applicable
1922 rules 14 days prior to the change.
1923 Section 58. Paragraphs (a) through (d) of subsection (4) of
1924 section 400.9905, Florida Statutes, are amended to read:
1925 400.9905 Definitions.—
1926 (4) “Clinic” means an entity where health care services are
1927 provided to individuals and which tenders charges for
1928 reimbursement for such services, including a mobile clinic and a
1929 portable equipment provider. As used in this part, the term does
1930 not include and the licensure requirements of this part do not
1931 apply to:
1932 (a) Entities licensed or registered by the state under
1933 chapter 395; entities licensed or registered by the state and
1934 providing only health care services within the scope of services
1935 authorized under their respective licenses under ss. 383.30
1936 383.332 383.30-383.335, chapter 390, chapter 394, chapter 397,
1937 this chapter except part X, chapter 429, chapter 463, chapter
1938 465, chapter 466, chapter 478, part I of chapter 483, chapter
1939 484, or chapter 651; end-stage renal disease providers
1940 authorized under 42 C.F.R. part 405, subpart U; providers
1941 certified under 42 C.F.R. part 485, subpart B or subpart H; or
1942 any entity that provides neonatal or pediatric hospital-based
1943 health care services or other health care services by licensed
1944 practitioners solely within a hospital licensed under chapter
1945 395.
1946 (b) Entities that own, directly or indirectly, entities
1947 licensed or registered by the state pursuant to chapter 395;
1948 entities that own, directly or indirectly, entities licensed or
1949 registered by the state and providing only health care services
1950 within the scope of services authorized pursuant to their
1951 respective licenses under ss. 383.30-383.332 383.30-383.335,
1952 chapter 390, chapter 394, chapter 397, this chapter except part
1953 X, chapter 429, chapter 463, chapter 465, chapter 466, chapter
1954 478, part I of chapter 483, chapter 484, or chapter 651; end
1955 stage renal disease providers authorized under 42 C.F.R. part
1956 405, subpart U; providers certified under 42 C.F.R. part 485,
1957 subpart B or subpart H; or any entity that provides neonatal or
1958 pediatric hospital-based health care services by licensed
1959 practitioners solely within a hospital licensed under chapter
1960 395.
1961 (c) Entities that are owned, directly or indirectly, by an
1962 entity licensed or registered by the state pursuant to chapter
1963 395; entities that are owned, directly or indirectly, by an
1964 entity licensed or registered by the state and providing only
1965 health care services within the scope of services authorized
1966 pursuant to their respective licenses under ss. 383.30-383.332
1967 383.30-383.335, chapter 390, chapter 394, chapter 397, this
1968 chapter except part X, chapter 429, chapter 463, chapter 465,
1969 chapter 466, chapter 478, part I of chapter 483, chapter 484, or
1970 chapter 651; end-stage renal disease providers authorized under
1971 42 C.F.R. part 405, subpart U; providers certified under 42
1972 C.F.R. part 485, subpart B or subpart H; or any entity that
1973 provides neonatal or pediatric hospital-based health care
1974 services by licensed practitioners solely within a hospital
1975 under chapter 395.
1976 (d) Entities that are under common ownership, directly or
1977 indirectly, with an entity licensed or registered by the state
1978 pursuant to chapter 395; entities that are under common
1979 ownership, directly or indirectly, with an entity licensed or
1980 registered by the state and providing only health care services
1981 within the scope of services authorized pursuant to their
1982 respective licenses under ss. 383.30-383.332 383.30-383.335,
1983 chapter 390, chapter 394, chapter 397, this chapter except part
1984 X, chapter 429, chapter 463, chapter 465, chapter 466, chapter
1985 478, part I of chapter 483, chapter 484, or chapter 651; end
1986 stage renal disease providers authorized under 42 C.F.R. part
1987 405, subpart U; providers certified under 42 C.F.R. part 485,
1988 subpart B or subpart H; or any entity that provides neonatal or
1989 pediatric hospital-based health care services by licensed
1990 practitioners solely within a hospital licensed under chapter
1991 395.
1992
1993 Notwithstanding this subsection, an entity shall be deemed a
1994 clinic and must be licensed under this part in order to receive
1995 reimbursement under the Florida Motor Vehicle No-Fault Law, ss.
1996 627.730-627.7405, unless exempted under s. 627.736(5)(h).
1997 Section 59. Subsection (6) of section 400.9935, Florida
1998 Statutes, is amended to read:
1999 400.9935 Clinic responsibilities.—
2000 (6) Any person or entity providing health care services
2001 which is not a clinic, as defined under s. 400.9905, may
2002 voluntarily apply for a certificate of exemption from licensure
2003 under its exempt status with the agency on a form that sets
2004 forth its name or names and addresses, a statement of the
2005 reasons why it cannot be defined as a clinic, and other
2006 information deemed necessary by the agency. An exemption may be
2007 valid for up to 2 years and is not transferable. The agency may
2008 charge an applicant for a certificate of exemption in an amount
2009 equal to $100 or the actual cost of processing the certificate,
2010 whichever is less. An entity seeking a certificate of exemption
2011 must publish and maintain a schedule of charges for the medical
2012 services offered to patients. The schedule must include the
2013 prices charged to an uninsured person paying for such services
2014 by cash, check, credit card, or debit card. The schedule must be
2015 posted in a conspicuous place in the reception area of the
2016 entity and must include, but is not limited to, the 50 services
2017 most frequently provided by the entity. The schedule may group
2018 services by three price levels, listing services in each price
2019 level. The posting must be at least 15 square feet in size. As a
2020 condition precedent to receiving a certificate of exemption, an
2021 applicant must provide to the agency documentation of compliance
2022 with these requirements.
2023 Section 60. Paragraph (a) of subsection (2) of section
2024 408.033, Florida Statutes, is amended to read:
2025 408.033 Local and state health planning.—
2026 (2) FUNDING.—
2027 (a) The Legislature intends that the cost of local health
2028 councils be borne by assessments on selected health care
2029 facilities subject to facility licensure by the Agency for
2030 Health Care Administration, including abortion clinics, assisted
2031 living facilities, ambulatory surgical centers, birth birthing
2032 centers, clinical laboratories except community nonprofit blood
2033 banks and clinical laboratories operated by practitioners for
2034 exclusive use regulated under s. 483.035, home health agencies,
2035 hospices, hospitals, intermediate care facilities for the
2036 developmentally disabled, nursing homes, health care clinics,
2037 and multiphasic testing centers and by assessments on
2038 organizations subject to certification by the agency pursuant to
2039 chapter 641, part III, including health maintenance
2040 organizations and prepaid health clinics. Fees assessed may be
2041 collected prospectively at the time of licensure renewal and
2042 prorated for the licensure period.
2043 Section 61. Present paragraphs (f) through (l) of
2044 subsection (3) of section 408.036, Florida Statutes, are
2045 redesignated as paragraphs (e) through (k), respectively,
2046 present paragraphs (o) through (t) of that subsection are
2047 redesignated as paragraphs (l) through (q), respectively, and
2048 present paragraphs (e), (m), (n), and (p) of that subsection are
2049 amended, to read:
2050 408.036 Projects subject to review; exemptions.—
2051 (3) EXEMPTIONS.—Upon request, the following projects are
2052 subject to exemption from the provisions of subsection (1):
2053 (e) For mobile surgical facilities and related health care
2054 services provided under contract with the Department of
2055 Corrections or a private correctional facility operating
2056 pursuant to chapter 957.
2057 (m)1. For the provision of adult open-heart services in a
2058 hospital located within the boundaries of a health service
2059 planning district, as defined in s. 408.032(5), which has
2060 experienced an annual net out-migration of at least 600 open
2061 heart-surgery cases for 3 consecutive years according to the
2062 most recent data reported to the agency, and the district’s
2063 population per licensed and operational open-heart programs
2064 exceeds the state average of population per licensed and
2065 operational open-heart programs by at least 25 percent. All
2066 hospitals within a health service planning district which meet
2067 the criteria reference in sub-subparagraphs 2.a.-h. shall be
2068 eligible for this exemption on July 1, 2004, and shall receive
2069 the exemption upon filing for it and subject to the following:
2070 a. A hospital that has received a notice of intent to grant
2071 a certificate of need or a final order of the agency granting a
2072 certificate of need for the establishment of an open-heart
2073 surgery program is entitled to receive a letter of exemption for
2074 the establishment of an adult open-heart-surgery program upon
2075 filing a request for exemption and complying with the criteria
2076 enumerated in sub-subparagraphs 2.a.-h., and is entitled to
2077 immediately commence operation of the program.
2078 b. An otherwise eligible hospital that has not received a
2079 notice of intent to grant a certificate of need or a final order
2080 of the agency granting a certificate of need for the
2081 establishment of an open-heart-surgery program is entitled to
2082 immediately receive a letter of exemption for the establishment
2083 of an adult open-heart-surgery program upon filing a request for
2084 exemption and complying with the criteria enumerated in sub
2085 subparagraphs 2.a.-h., but is not entitled to commence operation
2086 of its program until December 31, 2006.
2087 2. A hospital shall be exempt from the certificate-of-need
2088 review for the establishment of an open-heart-surgery program
2089 when the application for exemption submitted under this
2090 paragraph complies with the following criteria:
2091 a. The applicant must certify that it will meet and
2092 continuously maintain the minimum licensure requirements adopted
2093 by the agency governing adult open-heart programs, including the
2094 most current guidelines of the American College of Cardiology
2095 and American Heart Association Guidelines for Adult Open Heart
2096 Programs.
2097 b. The applicant must certify that it will maintain
2098 sufficient appropriate equipment and health personnel to ensure
2099 quality and safety.
2100 c. The applicant must certify that it will maintain
2101 appropriate times of operation and protocols to ensure
2102 availability and appropriate referrals in the event of
2103 emergencies.
2104 d. The applicant can demonstrate that it has discharged at
2105 least 300 inpatients with a principal diagnosis of ischemic
2106 heart disease for the most recent 12-month period as reported to
2107 the agency.
2108 e. The applicant is a general acute care hospital that is
2109 in operation for 3 years or more.
2110 f. The applicant is performing more than 300 diagnostic
2111 cardiac catheterization procedures per year, combined inpatient
2112 and outpatient.
2113 g. The applicant’s payor mix at a minimum reflects the
2114 community average for Medicaid, charity care, and self-pay
2115 patients or the applicant must certify that it will provide a
2116 minimum of 5 percent of Medicaid, charity care, and self-pay to
2117 open-heart-surgery patients.
2118 h. If the applicant fails to meet the established criteria
2119 for open-heart programs or fails to reach 300 surgeries per year
2120 by the end of its third year of operation, it must show cause
2121 why its exemption should not be revoked.
2122 3. By December 31, 2004, and annually thereafter, the
2123 agency shall submit a report to the Legislature providing
2124 information concerning the number of requests for exemption it
2125 has received under this paragraph during the calendar year and
2126 the number of exemptions it has granted or denied during the
2127 calendar year.
2128 (n) For the provision of percutaneous coronary intervention
2129 for patients presenting with emergency myocardial infarctions in
2130 a hospital without an approved adult open-heart-surgery program.
2131 In addition to any other documentation required by the agency, a
2132 request for an exemption submitted under this paragraph must
2133 comply with the following:
2134 1. The applicant must certify that it will meet and
2135 continuously maintain the requirements adopted by the agency for
2136 the provision of these services. These licensure requirements
2137 shall be adopted by rule and must be consistent with the
2138 guidelines published by the American College of Cardiology and
2139 the American Heart Association for the provision of percutaneous
2140 coronary interventions in hospitals without adult open-heart
2141 services. At a minimum, the rules must require the following:
2142 a. Cardiologists must be experienced interventionalists who
2143 have performed a minimum of 75 interventions within the previous
2144 12 months.
2145 b. The hospital must provide a minimum of 36 emergency
2146 interventions annually in order to continue to provide the
2147 service.
2148 c. The hospital must offer sufficient physician, nursing,
2149 and laboratory staff to provide the services 24 hours a day, 7
2150 days a week.
2151 d. Nursing and technical staff must have demonstrated
2152 experience in handling acutely ill patients requiring
2153 intervention based on previous experience in dedicated
2154 interventional laboratories or surgical centers.
2155 e. Cardiac care nursing staff must be adept in hemodynamic
2156 monitoring and Intra-aortic Balloon Pump (IABP) management.
2157 f. Formalized written transfer agreements must be developed
2158 with a hospital with an adult open-heart-surgery program, and
2159 written transport protocols must be in place to ensure safe and
2160 efficient transfer of a patient within 60 minutes. Transfer and
2161 transport agreements must be reviewed and tested, with
2162 appropriate documentation maintained at least every 3 months.
2163 However, a hospital located more than 100 road miles from the
2164 closest Level II adult cardiovascular services program does not
2165 need to meet the 60-minute transfer time protocol if the
2166 hospital demonstrates that it has a formalized, written transfer
2167 agreement with a hospital that has a Level II program. The
2168 agreement must include written transport protocols that ensure
2169 the safe and efficient transfer of a patient, taking into
2170 consideration the patient’s clinical and physical
2171 characteristics, road and weather conditions, and viability of
2172 ground and air ambulance service to transfer the patient.
2173 g. Hospitals implementing the service must first undertake
2174 a training program of 3 to 6 months’ duration, which includes
2175 establishing standards and testing logistics, creating quality
2176 assessment and error management practices, and formalizing
2177 patient-selection criteria.
2178 2. The applicant must certify that it will use at all times
2179 the patient-selection criteria for the performance of primary
2180 angioplasty at hospitals without adult open-heart-surgery
2181 programs issued by the American College of Cardiology and the
2182 American Heart Association. At a minimum, these criteria would
2183 provide for the following:
2184 a. Avoidance of interventions in hemodynamically stable
2185 patients who have identified symptoms or medical histories.
2186 b. Transfer of patients who have a history of coronary
2187 disease and clinical presentation of hemodynamic instability.
2188 3. The applicant must agree to submit a quarterly report to
2189 the agency detailing patient characteristics, treatment, and
2190 outcomes for all patients receiving emergency percutaneous
2191 coronary interventions pursuant to this paragraph. This report
2192 must be submitted within 15 days after the close of each
2193 calendar quarter.
2194 4. The exemption provided by this paragraph does not apply
2195 unless the agency determines that the hospital has taken all
2196 necessary steps to be in compliance with all requirements of
2197 this paragraph, including the training program required under
2198 sub-subparagraph 1.g.
2199 5. Failure of the hospital to continuously comply with the
2200 requirements of sub-subparagraphs 1.c.-f. and subparagraphs 2.
2201 and 3. will result in the immediate expiration of this
2202 exemption.
2203 6. Failure of the hospital to meet the volume requirements
2204 of sub-subparagraphs 1.a. and b. within 18 months after the
2205 program begins offering the service will result in the immediate
2206 expiration of the exemption.
2207
2208 If the exemption for this service expires under subparagraph 5.
2209 or subparagraph 6., the agency may not grant another exemption
2210 for this service to the same hospital for 2 years and then only
2211 upon a showing that the hospital will remain in compliance with
2212 the requirements of this paragraph through a demonstration of
2213 corrections to the deficiencies that caused expiration of the
2214 exemption. Compliance with the requirements of this paragraph
2215 includes compliance with the rules adopted pursuant to this
2216 paragraph.
2217 (m)(p) For replacement of a licensed nursing home on the
2218 same site, or within 5 miles of the same site if within the same
2219 subdistrict, if the number of licensed beds does not increase
2220 except as permitted under paragraph (e) (f).
2221 Section 62. Paragraph (b) of subsection (3) of section
2222 408.0361, Florida Statutes, is amended to read:
2223 408.0361 Cardiovascular services and burn unit licensure.—
2224 (3) In establishing rules for adult cardiovascular
2225 services, the agency shall include provisions that allow for:
2226 (b)1. For a hospital seeking a Level I program,
2227 demonstration that, for the most recent 12-month period as
2228 reported to the agency, it has provided a minimum of 300 adult
2229 inpatient and outpatient diagnostic cardiac catheterizations or,
2230 for the most recent 12-month period, has discharged or
2231 transferred at least 300 patients inpatients with the principal
2232 diagnosis of ischemic heart disease and that it has a
2233 formalized, written transfer agreement with a hospital that has
2234 a Level II program, including written transport protocols to
2235 ensure safe and efficient transfer of a patient within 60
2236 minutes.
2237 2.a. A hospital located more than 100 road miles from the
2238 closest Level II adult cardiovascular services program does not
2239 need to meet the diagnostic cardiac catheterization volume and
2240 ischemic heart disease diagnosis volume requirements in
2241 subparagraph 1., if the hospital demonstrates that it has, for
2242 the most recent 12-month period as reported to the agency,
2243 provided a minimum of 100 adult inpatient and outpatient
2244 diagnostic cardiac catheterizations or that, for the most recent
2245 12-month period, it has discharged or transferred at least 300
2246 patients with the principal diagnosis of ischemic heart disease.
2247 b. However, A hospital located more than 100 road miles
2248 from the closest Level II adult cardiovascular services program
2249 does not need to meet the 60-minute transfer time protocol
2250 requirement in subparagraph 1., if the hospital demonstrates
2251 that it has a formalized, written transfer agreement with a
2252 hospital that has a Level II program. The agreement must include
2253 written transport protocols to ensure the safe and efficient
2254 transfer of a patient, taking into consideration the patient’s
2255 clinical and physical characteristics, road and weather
2256 conditions, and viability of ground and air ambulance service to
2257 transfer the patient.
2258 3. At a minimum, the rules for adult cardiovascular
2259 services must require nursing and technical staff to have
2260 demonstrated experience in handling acutely ill patients
2261 requiring intervention, based on the staff member’s previous
2262 experience in dedicated cardiac interventional laboratories or
2263 surgical centers. If a staff member’s previous experience is in
2264 a dedicated cardiac interventional laboratory at a hospital that
2265 does not have an approved adult open-heart-surgery program, the
2266 staff member’s previous experience qualifies only if, at the
2267 time the staff member acquired his or her experience, the
2268 dedicated cardiac interventional laboratory:
2269 a. Had an annual volume of 500 or more percutaneous cardiac
2270 intervention procedures;
2271 b. Achieved a demonstrated success rate of 95 percent or
2272 greater for percutaneous cardiac intervention procedures;
2273 c. Experienced a complication rate of less than 5 percent
2274 for percutaneous cardiac intervention procedures; and
2275 d. Performed diverse cardiac procedures, including, but not
2276 limited to, balloon angioplasty and stenting, rotational
2277 atherectomy, cutting balloon atheroma remodeling, and procedures
2278 relating to left ventricular support capability.
2279 Section 63. Paragraph (k) is added to subsection (3) of
2280 section 408.05, Florida Statutes, to read:
2281 408.05 Florida Center for Health Information and
2282 Transparency.—
2283 (3) HEALTH INFORMATION TRANSPARENCY.—In order to
2284 disseminate and facilitate the availability of comparable and
2285 uniform health information, the agency shall perform the
2286 following functions:
2287 (k) Contract with the Society of Thoracic Surgeons and the
2288 American College of Cardiology to obtain data reported pursuant
2289 to s. 395.1055 for publication on the agency’s website in a
2290 manner that will allow consumers to be informed of aggregate
2291 data and to compare pediatric cardiac programs.
2292 Section 64. Subsection (4) of section 408.061, Florida
2293 Statutes, is amended to read:
2294 408.061 Data collection; uniform systems of financial
2295 reporting; information relating to physician charges;
2296 confidential information; immunity.—
2297 (4) Within 120 days after the end of its fiscal year, each
2298 health care facility, excluding continuing care facilities,
2299 hospitals operated by state agencies, and nursing homes as those
2300 terms are defined in s. 408.07 s. 408.07(14) and (37), shall
2301 file with the agency, on forms adopted by the agency and based
2302 on the uniform system of financial reporting, its actual
2303 financial experience for that fiscal year, including
2304 expenditures, revenues, and statistical measures. Such data may
2305 be based on internal financial reports which are certified to be
2306 complete and accurate by the provider. However, hospitals’
2307 actual financial experience shall be their audited actual
2308 experience. Every nursing home shall submit to the agency, in a
2309 format designated by the agency, a statistical profile of the
2310 nursing home residents. The agency, in conjunction with the
2311 Department of Elderly Affairs and the Department of Health,
2312 shall review these statistical profiles and develop
2313 recommendations for the types of residents who might more
2314 appropriately be placed in their homes or other noninstitutional
2315 settings.
2316 Section 65. Subsection (11) of section 408.07, Florida
2317 Statutes, is amended to read:
2318 408.07 Definitions.—As used in this chapter, with the
2319 exception of ss. 408.031-408.045, the term:
2320 (11) “Clinical laboratory” means a facility licensed under
2321 s. 483.091, excluding: any hospital laboratory defined under s.
2322 483.041(6); any clinical laboratory operated by the state or a
2323 political subdivision of the state; any blood or tissue bank
2324 where the majority of revenues are received from the sale of
2325 blood or tissue and where blood, plasma, or tissue is procured
2326 from volunteer donors and donated, processed, stored, or
2327 distributed on a nonprofit basis; and any clinical laboratory
2328 which is wholly owned and operated by physicians who are
2329 licensed pursuant to chapter 458 or chapter 459 and who practice
2330 in the same group practice, and at which no clinical laboratory
2331 work is performed for patients referred by any health care
2332 provider who is not a member of that same group practice.
2333 Section 66. Subsection (4) of section 408.20, Florida
2334 Statutes, is amended to read:
2335 408.20 Assessments; Health Care Trust Fund.—
2336 (4) Hospitals operated by a state agency the Department of
2337 Children and Families, the Department of Health, or the
2338 Department of Corrections are exempt from the assessments
2339 required under this section.
2340 Section 67. Section 408.7056, Florida Statutes, is
2341 repealed.
2342 Section 68. Subsections (10), (11), and (27) of section
2343 408.802, Florida Statutes, are amended to read:
2344 408.802 Applicability.—The provisions of this part apply to
2345 the provision of services that require licensure as defined in
2346 this part and to the following entities licensed, registered, or
2347 certified by the agency, as described in chapters 112, 383, 390,
2348 394, 395, 400, 429, 440, 483, and 765:
2349 (10) Mobile surgical facilities, as provided under part I
2350 of chapter 395.
2351 (11) Health care risk managers, as provided under part I of
2352 chapter 395.
2353 (27) Clinical laboratories, as provided under part I of
2354 chapter 483.
2355 Section 69. Subsections (12) and (13) of section 408.803,
2356 Florida Statutes, are redesignated as subsections (13) and (14),
2357 respectively, and a new subsection (12) is added to that
2358 section, to read:
2359 408.803 Definitions.—As used in this part, the term:
2360 (12) “Relative” means an individual who is the father,
2361 mother, stepfather, stepmother, son, daughter, brother, sister,
2362 grandmother, grandfather, great-grandmother, great-grandfather,
2363 grandson, granddaughter, uncle, aunt, first cousin, nephew,
2364 niece, husband, wife, father-in-law, mother-in-law, son-in-law,
2365 daughter-in-law, brother-in-law, sister-in-law, stepson,
2366 stepdaughter, stepbrother, stepsister, half-brother, or half
2367 sister of a patient or client.
2368 Section 70. Paragraph (c) of subsection (7) of section
2369 408.806, Florida Statutes, is amended, and subsection (9) is
2370 added to that section, to read:
2371 408.806 License application process.—
2372 (7)
2373 (c) If an inspection is required by the authorizing statute
2374 for a license application other than an initial application, the
2375 inspection must be unannounced. This paragraph does not apply to
2376 inspections required pursuant to ss. 383.324, 395.0161(4) and,
2377 429.67(6), and 483.061(2).
2378 (9) A licensee that holds a license for multiple providers
2379 licensed by the agency may request that all related license
2380 expiration dates be aligned. Upon such request, the agency may
2381 issue a license for an abbreviated licensure period with a
2382 prorated licensure fee.
2383 Section 71. Paragraphs (d) and (e) of subsection (1) of
2384 section 408.809, Florida Statutes, are amended to read:
2385 408.809 Background screening; prohibited offenses.—
2386 (1) Level 2 background screening pursuant to chapter 435
2387 must be conducted through the agency on each of the following
2388 persons, who are considered employees for the purposes of
2389 conducting screening under chapter 435:
2390 (d) Any person who is a controlling interest if the agency
2391 has reason to believe that such person has been convicted of any
2392 offense prohibited by s. 435.04. For each controlling interest
2393 who has been convicted of any such offense, the licensee shall
2394 submit to the agency a description and explanation of the
2395 conviction at the time of license application.
2396 (e) Any person, as required by authorizing statutes,
2397 seeking employment with a licensee or provider who is expected
2398 to, or whose responsibilities may require him or her to, provide
2399 personal care or services directly to clients or have access to
2400 client funds, personal property, or living areas; and any
2401 person, as required by authorizing statutes, contracting with a
2402 licensee or provider whose responsibilities require him or her
2403 to provide personal care or personal services directly to
2404 clients, or contracting with a licensee or provider to work 20
2405 hours a week or more who will have access to client funds,
2406 personal property, or living areas. Evidence of contractor
2407 screening may be retained by the contractor’s employer or the
2408 licensee.
2409 Section 72. Subsection (8) of section 408.810, Florida
2410 Statutes, is amended, and subsections (11), (12), and (13) are
2411 added to that section, to read:
2412 408.810 Minimum licensure requirements.—In addition to the
2413 licensure requirements specified in this part, authorizing
2414 statutes, and applicable rules, each applicant and licensee must
2415 comply with the requirements of this section in order to obtain
2416 and maintain a license.
2417 (8) Upon application for initial licensure or change of
2418 ownership licensure, the applicant shall furnish satisfactory
2419 proof of the applicant’s financial ability to operate in
2420 accordance with the requirements of this part, authorizing
2421 statutes, and applicable rules. The agency shall establish
2422 standards for this purpose, including information concerning the
2423 applicant’s controlling interests. The agency shall also
2424 establish documentation requirements, to be completed by each
2425 applicant, that show anticipated provider revenues and
2426 expenditures, the basis for financing the anticipated cash-flow
2427 requirements of the provider, and an applicant’s access to
2428 contingency financing. A current certificate of authority,
2429 pursuant to chapter 651, may be provided as proof of financial
2430 ability to operate. The agency may require a licensee to provide
2431 proof of financial ability to operate at any time if there is
2432 evidence of financial instability, including, but not limited
2433 to, unpaid expenses necessary for the basic operations of the
2434 provider. An applicant applying for change of ownership
2435 licensure is exempt from furnishing proof of financial ability
2436 to operate if the provider has been licensed for at least 5
2437 years, and:
2438 (a) The ownership change is a result of a corporate
2439 reorganization under which the controlling interest is unchanged
2440 and the applicant submits organizational charts that represent
2441 the current and proposed structure of the reorganized
2442 corporation; or
2443 (b) The ownership change is due solely to the death of a
2444 person holding a controlling interest, and the surviving
2445 controlling interests continue to hold at least 51 percent of
2446 ownership after the change of ownership.
2447 (11) The agency may adopt rules that govern the
2448 circumstances under which a controlling interest, an
2449 administrator, an employee, or a contractor, or a representative
2450 thereof, who is not a relative of the client may act as an agent
2451 of the client in authorizing consent for medical treatment,
2452 assignment of benefits, and release of information. Such rules
2453 may include requirements related to disclosure, bonding,
2454 restrictions, and client protections.
2455 (12) The licensee shall ensure that no person holds any
2456 ownership interest, either directly or indirectly, regardless of
2457 ownership structure, who:
2458 (a) Has a disqualifying offense pursuant to s. 408.809; or
2459 (b) Holds or has held any ownership interest, either
2460 directly or indirectly, regardless of ownership structure, in a
2461 provider that had a license revoked or an application denied
2462 pursuant to s. 408.815.
2463 (13) If the licensee is a publicly traded corporation or is
2464 wholly owned, directly or indirectly, by a publicly traded
2465 corporation, subsection (12) does not apply to those persons
2466 whose sole relationship with the corporation is as a shareholder
2467 of publicly traded shares. As used in this subsection, a
2468 “publicly traded corporation” is a corporation that issues
2469 securities traded on an exchange registered with the United
2470 States Securities and Exchange Commission as a national
2471 securities exchange.
2472 Section 73. Section 408.812, Florida Statutes, is amended
2473 to read:
2474 408.812 Unlicensed activity.—
2475 (1) A person or entity may not offer or advertise services
2476 that require licensure as defined by this part, authorizing
2477 statutes, or applicable rules to the public without obtaining a
2478 valid license from the agency. A licenseholder may not advertise
2479 or hold out to the public that he or she holds a license for
2480 other than that for which he or she actually holds the license.
2481 (2) The operation or maintenance of an unlicensed provider
2482 or the performance of any services that require licensure
2483 without proper licensure is a violation of this part and
2484 authorizing statutes. Unlicensed activity constitutes harm that
2485 materially affects the health, safety, and welfare of clients,
2486 and constitutes abuse and neglect, as defined in s. 415.102. The
2487 agency or any state attorney may, in addition to other remedies
2488 provided in this part, bring an action for an injunction to
2489 restrain such violation, or to enjoin the future operation or
2490 maintenance of the unlicensed provider or the performance of any
2491 services in violation of this part and authorizing statutes,
2492 until compliance with this part, authorizing statutes, and
2493 agency rules has been demonstrated to the satisfaction of the
2494 agency.
2495 (3) It is unlawful for any person or entity to own,
2496 operate, or maintain an unlicensed provider. If after receiving
2497 notification from the agency, such person or entity fails to
2498 cease operation and apply for a license under this part and
2499 authorizing statutes, the person or entity is shall be subject
2500 to penalties as prescribed by authorizing statutes and
2501 applicable rules. Each day of continued operation is a separate
2502 offense.
2503 (4) Any person or entity that fails to cease operation
2504 after agency notification may be fined $1,000 for each day of
2505 noncompliance.
2506 (5) When a controlling interest or licensee has an interest
2507 in more than one provider and fails to license a provider
2508 rendering services that require licensure, the agency may revoke
2509 all licenses, and impose actions under s. 408.814, and
2510 regardless of correction, impose a fine of $1,000 per day,
2511 unless otherwise specified by authorizing statutes, against each
2512 licensee until such time as the appropriate license is obtained
2513 or the unlicensed activity ceases for the unlicensed operation.
2514 (6) In addition to granting injunctive relief pursuant to
2515 subsection (2), if the agency determines that a person or entity
2516 is operating or maintaining a provider without obtaining a
2517 license and determines that a condition exists that poses a
2518 threat to the health, safety, or welfare of a client of the
2519 provider, the person or entity is subject to the same actions
2520 and fines imposed against a licensee as specified in this part,
2521 authorizing statutes, and agency rules.
2522 (7) Any person aware of the operation of an unlicensed
2523 provider must report that provider to the agency.
2524 Section 74. Subsections (10), (11) and (26) of section
2525 408.820, Florida Statutes, are amended, and subsections (12)
2526 through (25) and (27) and (28) are redesignated as subsections
2527 (10) through (23) and (24) and (25), respectively, to read:
2528 408.820 Exemptions.—Except as prescribed in authorizing
2529 statutes, the following exemptions shall apply to specified
2530 requirements of this part:
2531 (10) Mobile surgical facilities, as provided under part I
2532 of chapter 395, are exempt from s. 408.810(7)-(10).
2533 (11) Health care risk managers, as provided under part I of
2534 chapter 395, are exempt from ss. 408.806(7), 408.810(4)-(10),
2535 and 408.811.
2536 (26) Clinical laboratories, as provided under part I of
2537 chapter 483, are exempt from s. 408.810(5)-(10).
2538 Section 75. Subsection (7) of section 409.905, Florida
2539 Statutes, is amended to read:
2540 409.905 Mandatory Medicaid services.—The agency may make
2541 payments for the following services, which are required of the
2542 state by Title XIX of the Social Security Act, furnished by
2543 Medicaid providers to recipients who are determined to be
2544 eligible on the dates on which the services were provided. Any
2545 service under this section shall be provided only when medically
2546 necessary and in accordance with state and federal law.
2547 Mandatory services rendered by providers in mobile units to
2548 Medicaid recipients may be restricted by the agency. Nothing in
2549 this section shall be construed to prevent or limit the agency
2550 from adjusting fees, reimbursement rates, lengths of stay,
2551 number of visits, number of services, or any other adjustments
2552 necessary to comply with the availability of moneys and any
2553 limitations or directions provided for in the General
2554 Appropriations Act or chapter 216.
2555 (7) INDEPENDENT LABORATORY SERVICES.—The agency shall pay
2556 for medically necessary diagnostic laboratory procedures ordered
2557 by a licensed physician or other licensed practitioner of the
2558 healing arts which are provided for a recipient in a laboratory
2559 that meets the requirements for Medicare participation and is
2560 appropriately certified by the Centers for Medicare and Medicaid
2561 Services under the federal Clinical Laboratory Improvement
2562 Amendments and the federal rules adopted thereunder licensed
2563 under chapter 483, if required.
2564 Section 76. Subsection (10) of section 409.907, Florida
2565 Statutes, is amended to read:
2566 409.907 Medicaid provider agreements.—The agency may make
2567 payments for medical assistance and related services rendered to
2568 Medicaid recipients only to an individual or entity who has a
2569 provider agreement in effect with the agency, who is performing
2570 services or supplying goods in accordance with federal, state,
2571 and local law, and who agrees that no person shall, on the
2572 grounds of handicap, race, color, or national origin, or for any
2573 other reason, be subjected to discrimination under any program
2574 or activity for which the provider receives payment from the
2575 agency.
2576 (10) The agency may consider whether the provider, or any
2577 officer, director, agent, managing employee, or affiliated
2578 person, or any partner or shareholder having an ownership
2579 interest equal to 5 percent or greater in the provider if the
2580 provider is a corporation, partnership, or other business
2581 entity, has:
2582 (a) Made a false representation or omission of any material
2583 fact in making the application, including the submission of an
2584 application that conceals the controlling or ownership interest
2585 of any officer, director, agent, managing employee, affiliated
2586 person, or partner or shareholder who may not be eligible to
2587 participate;
2588 (b) Been or is currently excluded, suspended, terminated
2589 from, or has involuntarily withdrawn from participation in,
2590 Florida’s Medicaid program or any other state’s Medicaid
2591 program, or from participation in any other governmental or
2592 private health care or health insurance program;
2593 (c) Been convicted of a criminal offense relating to the
2594 delivery of any goods or services under Medicaid or Medicare or
2595 any other public or private health care or health insurance
2596 program including the performance of management or
2597 administrative services relating to the delivery of goods or
2598 services under any such program;
2599 (d) Been convicted under federal or state law of a criminal
2600 offense related to the neglect or abuse of a patient in
2601 connection with the delivery of any health care goods or
2602 services;
2603 (e) Been convicted under federal or state law of a criminal
2604 offense relating to the unlawful manufacture, distribution,
2605 prescription, or dispensing of a controlled substance;
2606 (f) Been convicted of any criminal offense relating to
2607 fraud, theft, embezzlement, breach of fiduciary responsibility,
2608 or other financial misconduct;
2609 (g) Been convicted under federal or state law of a crime
2610 punishable by imprisonment of a year or more which involves
2611 moral turpitude;
2612 (h) Been convicted in connection with the interference or
2613 obstruction of any investigation into any criminal offense
2614 listed in this subsection;
2615 (i) Been found to have violated federal or state laws,
2616 rules, or regulations governing Florida’s Medicaid program or
2617 any other state’s Medicaid program, the Medicare program, or any
2618 other publicly funded federal or state health care or health
2619 insurance program, and been sanctioned accordingly;
2620 (c)(j) Been previously found by a licensing, certifying, or
2621 professional standards board or agency to have violated the
2622 standards or conditions relating to licensure or certification
2623 or the quality of services provided; or
2624 (d)(k) Failed to pay any fine or overpayment properly
2625 assessed under the Medicaid program in which no appeal is
2626 pending or after resolution of the proceeding by stipulation or
2627 agreement, unless the agency has issued a specific letter of
2628 forgiveness or has approved a repayment schedule to which the
2629 provider agrees to adhere.
2630 Section 77. Subsection (6) of section 409.9116, Florida
2631 Statutes, is amended to read:
2632 409.9116 Disproportionate share/financial assistance
2633 program for rural hospitals.—In addition to the payments made
2634 under s. 409.911, the Agency for Health Care Administration
2635 shall administer a federally matched disproportionate share
2636 program and a state-funded financial assistance program for
2637 statutory rural hospitals. The agency shall make
2638 disproportionate share payments to statutory rural hospitals
2639 that qualify for such payments and financial assistance payments
2640 to statutory rural hospitals that do not qualify for
2641 disproportionate share payments. The disproportionate share
2642 program payments shall be limited by and conform with federal
2643 requirements. Funds shall be distributed quarterly in each
2644 fiscal year for which an appropriation is made. Notwithstanding
2645 the provisions of s. 409.915, counties are exempt from
2646 contributing toward the cost of this special reimbursement for
2647 hospitals serving a disproportionate share of low-income
2648 patients.
2649 (6) This section applies only to hospitals that were
2650 defined as statutory rural hospitals, or their successor-in
2651 interest hospital, prior to January 1, 2001. Any additional
2652 hospital that is defined as a statutory rural hospital, or its
2653 successor-in-interest hospital, on or after January 1, 2001, is
2654 not eligible for programs under this section unless additional
2655 funds are appropriated each fiscal year specifically to the
2656 rural hospital disproportionate share and financial assistance
2657 programs in an amount necessary to prevent any hospital, or its
2658 successor-in-interest hospital, eligible for the programs prior
2659 to January 1, 2001, from incurring a reduction in payments
2660 because of the eligibility of an additional hospital to
2661 participate in the programs. A hospital, or its successor-in
2662 interest hospital, which received funds pursuant to this section
2663 before January 1, 2001, and which qualifies under s.
2664 395.602(2)(b) s. 395.602(2)(e), shall be included in the
2665 programs under this section and is not required to seek
2666 additional appropriations under this subsection.
2667 Section 78. Paragraphs (a) and (b) of subsection (1) of
2668 section 409.975, Florida Statutes, are amended to read:
2669 409.975 Managed care plan accountability.—In addition to
2670 the requirements of s. 409.967, plans and providers
2671 participating in the managed medical assistance program shall
2672 comply with the requirements of this section.
2673 (1) PROVIDER NETWORKS.—Managed care plans must develop and
2674 maintain provider networks that meet the medical needs of their
2675 enrollees in accordance with standards established pursuant to
2676 s. 409.967(2)(c). Except as provided in this section, managed
2677 care plans may limit the providers in their networks based on
2678 credentials, quality indicators, and price.
2679 (a) Plans must include all providers in the region that are
2680 classified by the agency as essential Medicaid providers, unless
2681 the agency approves, in writing, an alternative arrangement for
2682 securing the types of services offered by the essential
2683 providers. Providers are essential for serving Medicaid
2684 enrollees if they offer services that are not available from any
2685 other provider within a reasonable access standard, or if they
2686 provided a substantial share of the total units of a particular
2687 service used by Medicaid patients within the region during the
2688 last 3 years and the combined capacity of other service
2689 providers in the region is insufficient to meet the total needs
2690 of the Medicaid patients. The agency may not classify physicians
2691 and other practitioners as essential providers. The agency, at a
2692 minimum, shall determine which providers in the following
2693 categories are essential Medicaid providers:
2694 1. Federally qualified health centers.
2695 2. Statutory teaching hospitals as defined in s. 408.07(44)
2696 s. 408.07(45).
2697 3. Hospitals that are trauma centers as defined in s.
2698 395.4001(14).
2699 4. Hospitals located at least 25 miles from any other
2700 hospital with similar services.
2701
2702 Managed care plans that have not contracted with all essential
2703 providers in the region as of the first date of recipient
2704 enrollment, or with whom an essential provider has terminated
2705 its contract, must negotiate in good faith with such essential
2706 providers for 1 year or until an agreement is reached, whichever
2707 is first. Payments for services rendered by a nonparticipating
2708 essential provider shall be made at the applicable Medicaid rate
2709 as of the first day of the contract between the agency and the
2710 plan. A rate schedule for all essential providers shall be
2711 attached to the contract between the agency and the plan. After
2712 1 year, managed care plans that are unable to contract with
2713 essential providers shall notify the agency and propose an
2714 alternative arrangement for securing the essential services for
2715 Medicaid enrollees. The arrangement must rely on contracts with
2716 other participating providers, regardless of whether those
2717 providers are located within the same region as the
2718 nonparticipating essential service provider. If the alternative
2719 arrangement is approved by the agency, payments to
2720 nonparticipating essential providers after the date of the
2721 agency’s approval shall equal 90 percent of the applicable
2722 Medicaid rate. Except for payment for emergency services, if the
2723 alternative arrangement is not approved by the agency, payment
2724 to nonparticipating essential providers shall equal 110 percent
2725 of the applicable Medicaid rate.
2726 (b) Certain providers are statewide resources and essential
2727 providers for all managed care plans in all regions. All managed
2728 care plans must include these essential providers in their
2729 networks. Statewide essential providers include:
2730 1. Faculty plans of Florida medical schools.
2731 2. Regional perinatal intensive care centers as defined in
2732 s. 383.16(2).
2733 3. Hospitals licensed as specialty children’s hospitals as
2734 defined in s. 395.002(27) s. 395.002(28).
2735 4. Accredited and integrated systems serving medically
2736 complex children which comprise separately licensed, but
2737 commonly owned, health care providers delivering at least the
2738 following services: medical group home, in-home and outpatient
2739 nursing care and therapies, pharmacy services, durable medical
2740 equipment, and Prescribed Pediatric Extended Care.
2741
2742 Managed care plans that have not contracted with all statewide
2743 essential providers in all regions as of the first date of
2744 recipient enrollment must continue to negotiate in good faith.
2745 Payments to physicians on the faculty of nonparticipating
2746 Florida medical schools shall be made at the applicable Medicaid
2747 rate. Payments for services rendered by regional perinatal
2748 intensive care centers shall be made at the applicable Medicaid
2749 rate as of the first day of the contract between the agency and
2750 the plan. Except for payments for emergency services, payments
2751 to nonparticipating specialty children’s hospitals shall equal
2752 the highest rate established by contract between that provider
2753 and any other Medicaid managed care plan.
2754 Section 79. Subsections (5) and (17) of section 429.02,
2755 Florida Statutes, are amended to read:
2756 429.02 Definitions.—When used in this part, the term:
2757 (5) “Assisted living facility” means any building or
2758 buildings, section or distinct part of a building, private home,
2759 boarding home, home for the aged, or other residential facility,
2760 regardless of whether operated for profit or not, which
2761 undertakes through its ownership or management provides to
2762 provide housing, meals, and one or more personal services for a
2763 period exceeding 24 hours to one or more adults who are not
2764 relatives of the owner or administrator.
2765 (17) “Personal services” means direct physical assistance
2766 with or supervision of the activities of daily living, and the
2767 self-administration of medication, or and other similar services
2768 which the department may define by rule. The term may “Personal
2769 services” shall not be construed to mean the provision of
2770 medical, nursing, dental, or mental health services.
2771 Section 80. Paragraphs (b) and (d) of subsection (2) of
2772 section 429.04, Florida Statutes, are amended, and subsection
2773 (3) is added that section, to read:
2774 429.04 Facilities to be licensed; exemptions.—
2775 (2) The following are exempt from licensure under this
2776 part:
2777 (b) Any facility or part of a facility licensed by the
2778 Agency for Persons with Disabilities under chapter 393, a mental
2779 health facility licensed under or chapter 394, a hospital
2780 licensed under chapter 395, a nursing home licensed under part
2781 II of chapter 400, an inpatient hospice licensed under part IV
2782 of chapter 400, a home for special services licensed under part
2783 V of chapter 400, an intermediate care facility licensed under
2784 part VIII of chapter 400, or a transitional living facility
2785 licensed under part XI of chapter 400.
2786 (d) Any person who provides housing, meals, and one or more
2787 personal services on a 24-hour basis in the person’s own home to
2788 not more than two adults who do not receive optional state
2789 supplementation. The person who provides the housing, meals, and
2790 personal services must own or rent the home and must have
2791 established the home as his or her permanent residence. For
2792 purposes of this paragraph, any person holding a homestead
2793 exemption at an address other than that at which the person
2794 asserts this exemption is presumed to not have established
2795 permanent residence reside therein. This exemption does not
2796 apply to a person or entity that previously held a license
2797 issued by the agency which was revoked or for which renewal was
2798 denied by final order of the agency, or when the person or
2799 entity voluntarily relinquished the license during agency
2800 enforcement proceedings.
2801 (3) Upon agency investigation of unlicensed activity, any
2802 person or entity that claims that it is exempt under this
2803 section must provide documentation substantiating entitlement to
2804 the exemption.
2805 Section 81. Paragraphs (b) and (d) of subsection (1) of
2806 section 429.08, Florida Statutes, are amended to read:
2807 429.08 Unlicensed facilities; referral of person for
2808 residency to unlicensed facility; penalties.—
2809 (1)
2810 (b) Except as provided under paragraph (d), Any person who
2811 owns, rents, or otherwise maintains a building or property used
2812 as operates, or maintains an unlicensed assisted living facility
2813 commits a felony of the third degree, punishable as provided in
2814 s. 775.082, s. 775.083, or s. 775.084. Each day of continued
2815 operation is a separate offense.
2816 (d) In addition to the requirements of s. 408.812, any
2817 person who owns, operates, or maintains an unlicensed assisted
2818 living facility after receiving notice from the agency due to a
2819 change in this part or a modification in rule within 6 months
2820 after the effective date of such change and who, within 10
2821 working days after receiving notification from the agency, fails
2822 to cease operation or apply for a license under this part
2823 commits a felony of the third degree, punishable as provided in
2824 s. 775.082, s. 775.083, or s. 775.084. Each day of continued
2825 operation is a separate offense.
2826 Section 82. Section 429.176, Florida Statutes, is amended
2827 to read:
2828 429.176 Notice of change of administrator.—If, during the
2829 period for which a license is issued, the owner changes
2830 administrators, the owner must notify the agency of the change
2831 within 10 days and provide documentation within 90 days that the
2832 new administrator has completed the applicable core educational
2833 requirements under s. 429.52. A facility may not be operated for
2834 more than 120 consecutive days without an administrator who has
2835 completed the core educational requirements.
2836 Section 83. Subsection (7) of section 429.19, Florida
2837 Statutes, is amended to read:
2838 429.19 Violations; imposition of administrative fines;
2839 grounds.—
2840 (7) In addition to any administrative fines imposed, the
2841 agency may assess a survey fee, equal to the lesser of one half
2842 of the facility’s biennial license and bed fee or $500, to cover
2843 the cost of conducting initial complaint investigations that
2844 result in the finding of a violation that was the subject of the
2845 complaint or monitoring visits conducted under s. 429.28(3)(c)
2846 to verify the correction of the violations.
2847 Section 84. Subsection (2) of section 429.24, Florida
2848 Statutes, is amended to read:
2849 429.24 Contracts.—
2850 (2) Each contract must contain express provisions
2851 specifically setting forth the services and accommodations to be
2852 provided by the facility; the rates or charges; provision for at
2853 least 30 days’ written notice of a rate increase; the rights,
2854 duties, and obligations of the residents, other than those
2855 specified in s. 429.28; and other matters that the parties deem
2856 appropriate. A new service or accommodation added to, or
2857 implemented in, a resident’s contract for which the resident was
2858 not previously charged does not require a 30-day written notice
2859 of a rate increase. Whenever money is deposited or advanced by a
2860 resident in a contract as security for performance of the
2861 contract agreement or as advance rent for other than the next
2862 immediate rental period:
2863 (a) Such funds shall be deposited in a banking institution
2864 in this state that is located, if possible, in the same
2865 community in which the facility is located; shall be kept
2866 separate from the funds and property of the facility; may not be
2867 represented as part of the assets of the facility on financial
2868 statements; and shall be used, or otherwise expended, only for
2869 the account of the resident.
2870 (b) The licensee shall, within 30 days of receipt of
2871 advance rent or a security deposit, notify the resident or
2872 residents in writing of the manner in which the licensee is
2873 holding the advance rent or security deposit and state the name
2874 and address of the depository where the moneys are being held.
2875 The licensee shall notify residents of the facility’s policy on
2876 advance deposits.
2877 Section 85. Paragraphs (e) and (j) of subsection (1) and
2878 paragraphs (c), (d), and (e) of subsection (3) of section
2879 429.28, Florida Statutes, are amended to read:
2880 429.28 Resident bill of rights.—
2881 (1) No resident of a facility shall be deprived of any
2882 civil or legal rights, benefits, or privileges guaranteed by
2883 law, the Constitution of the State of Florida, or the
2884 Constitution of the United States as a resident of a facility.
2885 Every resident of a facility shall have the right to:
2886 (e) Freedom to participate in and benefit from community
2887 services and activities and to pursue achieve the highest
2888 possible level of independence, autonomy, and interaction within
2889 the community.
2890 (j) Assistance with obtaining access to adequate and
2891 appropriate health care. For purposes of this paragraph, the
2892 term “adequate and appropriate health care” means the management
2893 of medications, assistance in making appointments for health
2894 care services, the provision of or arrangement of transportation
2895 to health care appointments, and the performance of health care
2896 services in accordance with s. 429.255 which are consistent with
2897 established and recognized standards within the community.
2898 (3)
2899 (c) During any calendar year in which no survey is
2900 conducted, the agency shall conduct at least one monitoring
2901 visit of each facility cited in the previous year for a class I
2902 or class II violation, or more than three uncorrected class III
2903 violations.
2904 (d) The agency may conduct periodic followup inspections as
2905 necessary to monitor the compliance of facilities with a history
2906 of any class I, class II, or class III violations that threaten
2907 the health, safety, or security of residents.
2908 (e) The agency may conduct complaint investigations as
2909 warranted to investigate any allegations of noncompliance with
2910 requirements required under this part or rules adopted under
2911 this part.
2912 Section 86. Subsection (1) of section 429.294, Florida
2913 Statutes, is amended to read:
2914 429.294 Availability of facility records for investigation
2915 of resident’s rights violations and defenses; penalty.—
2916 (1) Failure to provide complete copies of a resident’s
2917 records, including, but not limited to, all medical records and
2918 the resident’s chart, within the control or possession of the
2919 facility within 10 days, in accordance with the provisions of s.
2920 400.145, shall constitute evidence of failure of that party to
2921 comply with good faith discovery requirements and shall waive
2922 the good faith certificate and presuit notice requirements under
2923 this part by the requesting party.
2924 Section 87. Subsection (2) of section 429.34, Florida
2925 Statutes, is amended to read:
2926 429.34 Right of entry and inspection.—
2927 (2)(a) In addition to the requirements of s. 408.811, the
2928 agency may inspect and investigate facilities as necessary to
2929 determine compliance with this part, part II of chapter 408, and
2930 rules adopted thereunder. The agency shall inspect each licensed
2931 assisted living facility at least once every 24 months to
2932 determine compliance with this chapter and related rules. If an
2933 assisted living facility is cited for a class I violation or
2934 three or more class II violations arising from separate surveys
2935 within a 60-day period or due to unrelated circumstances during
2936 the same survey, the agency must conduct an additional licensure
2937 inspection within 6 months.
2938 (b) During any calendar year in which a survey is not
2939 conducted, the agency may conduct monitoring visits of each
2940 facility cited in the previous year for a class I or class II
2941 violation or for more than three uncorrected class III
2942 violations.
2943 Section 88. Subsection (4) of section 429.52, Florida
2944 Statutes, is amended to read:
2945 429.52 Staff training and educational programs; core
2946 educational requirement.—
2947 (4) Effective January 1, 2004, a new facility administrator
2948 must complete the required training and education, including the
2949 competency test, within 90 days after date of employment a
2950 reasonable time after being employed as an administrator, as
2951 determined by the department. Failure to do so is a violation of
2952 this part and subjects the violator to an administrative fine as
2953 prescribed in s. 429.19. Administrators licensed in accordance
2954 with part II of chapter 468 are exempt from this requirement.
2955 Other licensed professionals may be exempted, as determined by
2956 the department by rule.
2957 Section 89. Subsection (3) of section 435.04, Florida
2958 Statutes, is amended, and subsection (4) is added to that
2959 section, to read:
2960 435.04 Level 2 screening standards.—
2961 (3) The security background investigations under this
2962 section must ensure that no person subject to this section has
2963 been arrested for and is awaiting final disposition of, been
2964 found guilty of, regardless of adjudication, or entered a plea
2965 of nolo contendere or guilty to, any offense that constitutes
2966 domestic violence as defined in s. 741.28, whether such act was
2967 committed in this state or in another jurisdiction.
2968 (4) For the purpose of screening applicability to
2969 participate in the Medicaid program, the security background
2970 investigations under this section must ensure that a person
2971 subject to screening under this section has not been arrested
2972 for and is not awaiting final disposition of; has not been found
2973 guilty of, regardless of adjudication, or entered a plea of nolo
2974 contendere or guilty to; and has not been adjudicated delinquent
2975 and the record sealed or expunged for, any of the following
2976 offenses:
2977 (a) Violation of a federal law or a law in any state which
2978 creates a criminal offense relating to:
2979 1. The delivery of any goods or services under Medicaid or
2980 Medicare or any other public or private health care or health
2981 insurance program, including the performance of management or
2982 administrative services relating to the delivery of goods or
2983 services under any such program;
2984 2. Neglect or abuse of a patient in connection with the
2985 delivery of any health care good or service;
2986 3. Unlawful manufacture, distribution, prescription, or
2987 dispensing of a controlled substance;
2988 4. Fraud, theft, embezzlement, breach of fiduciary
2989 responsibility, or other financial misconduct; or
2990 5. Moral turpitude, if punishable by imprisonment of a year
2991 or more.
2992 6. Interference with or obstruction of an investigation
2993 into any criminal offense identified in this subsection.
2994 (b) Violation of the following state laws or laws of
2995 another jurisdiction:
2996 1. Section 817.569, criminal use of a public record or
2997 information contained in a public record;
2998 2. Section 838.016, unlawful compensation or reward for
2999 official behavior;
3000 3. Section 838.021, corruption by threat against a public
3001 servant;
3002 4. Section 838.022, official misconduct;
3003 5. Section 838.22, bid tampering;
3004 6. Section 839.13, falsifying records;
3005 7. Section 839.26, misuse of confidential information; or
3006 (c) Violation of a federal or state law, rule, or
3007 regulation governing the Florida Medicaid program or any other
3008 state Medicaid program, the Medicare program, or any other
3009 publicly funded federal or state health care or health insurance
3010 program.
3011 Section 90. Subsection (4) of section 456.001, Florida
3012 Statutes, is amended to read:
3013 456.001 Definitions.—As used in this chapter, the term:
3014 (4) “Health care practitioner” means any person licensed
3015 under chapter 457; chapter 458; chapter 459; chapter 460;
3016 chapter 461; chapter 462; chapter 463; chapter 464; chapter 465;
3017 chapter 466; chapter 467; part I, part II, part III, part V,
3018 part X, part XIII, or part XIV of chapter 468; chapter 478;
3019 chapter 480; part II or part III or part IV of chapter 483;
3020 chapter 484; chapter 486; chapter 490; or chapter 491.
3021 Section 91. Subsection (3) of section 456.054, Florida
3022 Statutes, is redesignated as subsection (4), and a new
3023 subsection (3) is added to that section, to read:
3024 456.054 Kickbacks prohibited.—
3025 (3)(a) It is unlawful for any person or any entity to pay
3026 or receive, directly or indirectly, a commission, bonus,
3027 kickback, or rebate from, or to engage in any form of a split
3028 fee arrangement with, a dialysis facility, health care
3029 practitioner, surgeon, person, or entity for referring patients
3030 to a clinical laboratory as defined in s. 483.803.
3031 (b) It is unlawful for any clinical laboratory to:
3032 1. Provide personnel to perform any functions or duties in
3033 a health care practitioner’s office or dialysis facility for any
3034 purpose, including for the collection or handling of specimens,
3035 directly or indirectly through an employee, contractor,
3036 independent staffing company, lease agreement, or otherwise,
3037 unless the laboratory and the practitioner’s office, or dialysis
3038 facility, are wholly owned and operated by the same entity.
3039 2. Lease space within any part of a health care
3040 practitioner’s office or dialysis facility for any purpose,
3041 including for the purpose of establishing a collection station
3042 where materials or specimens are collected or drawn from
3043 patients.
3044 Section 92. Paragraphs (h) and (i) of subsection (2) of
3045 section 456.057, Florida Statutes, are amended to read:
3046 456.057 Ownership and control of patient records; report or
3047 copies of records to be furnished; disclosure of information.—
3048 (2) As used in this section, the terms “records owner,”
3049 “health care practitioner,” and “health care practitioner’s
3050 employer” do not include any of the following persons or
3051 entities; furthermore, the following persons or entities are not
3052 authorized to acquire or own medical records, but are authorized
3053 under the confidentiality and disclosure requirements of this
3054 section to maintain those documents required by the part or
3055 chapter under which they are licensed or regulated:
3056 (h) Clinical laboratory personnel licensed under part II
3057 III of chapter 483.
3058 (i) Medical physicists licensed under part III IV of
3059 chapter 483.
3060 Section 93. Paragraph (j) of subsection (1) of section
3061 456.076, Florida Statutes, is amended to read:
3062 456.076 Impaired practitioner programs.—
3063 (1) As used in this section, the term:
3064 (j) “Practitioner” means a person licensed, registered,
3065 certified, or regulated by the department under part III of
3066 chapter 401; chapter 457; chapter 458; chapter 459; chapter 460;
3067 chapter 461; chapter 462; chapter 463; chapter 464; chapter 465;
3068 chapter 466; chapter 467; part I, part II, part III, part V,
3069 part X, part XIII, or part XIV of chapter 468; chapter 478;
3070 chapter 480; part II or part III or part IV of chapter 483;
3071 chapter 484; chapter 486; chapter 490; or chapter 491; or an
3072 applicant for a license, registration, or certification under
3073 the same laws.
3074 Section 94. Subsection (2) of section 458.307, Florida
3075 Statutes, is amended to read:
3076 458.307 Board of Medicine.—
3077 (2) Twelve members of the board must be licensed physicians
3078 in good standing in this state who are residents of the state
3079 and who have been engaged in the active practice or teaching of
3080 medicine for at least 4 years immediately preceding their
3081 appointment. One of the physicians must be on the full-time
3082 faculty of a medical school in this state, and one of the
3083 physicians must be in private practice and on the full-time
3084 staff of a statutory teaching hospital in this state as defined
3085 in s. 408.07. At least one of the physicians must be a graduate
3086 of a foreign medical school. The remaining three members must be
3087 residents of the state who are not, and never have been,
3088 licensed health care practitioners. One member must be a health
3089 care risk manager licensed under s. 395.10974. At least one
3090 member of the board must be 60 years of age or older.
3091 Section 95. Subsection (1) of section 458.345, Florida
3092 Statutes, is amended to read:
3093 458.345 Registration of resident physicians, interns, and
3094 fellows; list of hospital employees; prescribing of medicinal
3095 drugs; penalty.—
3096 (1) Any person desiring to practice as a resident
3097 physician, assistant resident physician, house physician,
3098 intern, or fellow in fellowship training which leads to
3099 subspecialty board certification in this state, or any person
3100 desiring to practice as a resident physician, assistant resident
3101 physician, house physician, intern, or fellow in fellowship
3102 training in a teaching hospital in this state as defined in s.
3103 408.07 s. 408.07(45) or s. 395.805(2), who does not hold a
3104 valid, active license issued under this chapter shall apply to
3105 the department to be registered and shall remit a fee not to
3106 exceed $300 as set by the board. The department shall register
3107 any applicant the board certifies has met the following
3108 requirements:
3109 (a) Is at least 21 years of age.
3110 (b) Has not committed any act or offense within or without
3111 the state which would constitute the basis for refusal to
3112 certify an application for licensure pursuant to s. 458.331.
3113 (c) Is a graduate of a medical school or college as
3114 specified in s. 458.311(1)(f).
3115 Section 96. Subsection (1) of s. 459.021, Florida Statutes,
3116 is amended to read:
3117 459.021 Registration of resident physicians, interns, and
3118 fellows; list of hospital employees; penalty.—
3119 (1) Any person who holds a degree of Doctor of Osteopathic
3120 Medicine from a college of osteopathic medicine recognized and
3121 approved by the American Osteopathic Association who desires to
3122 practice as a resident physician, intern, or fellow in
3123 fellowship training which leads to subspecialty board
3124 certification in this state, or any person desiring to practice
3125 as a resident physician, intern, or fellow in fellowship
3126 training in a teaching hospital in this state as defined in s.
3127 408.07 s. 408.07(45) or s. 395.805(2), who does not hold an
3128 active license issued under this chapter shall apply to the
3129 department to be registered, on an application provided by the
3130 department, before commencing such a training program and shall
3131 remit a fee not to exceed $300 as set by the board.
3132 Section 97. Part I of chapter 483, Florida Statutes,
3133 consisting of sections 483.011, 483.021, 483.031, 483.035,
3134 483.041, 483.051, 483.061, 483.091, 483.101, 483.111, 483.172,
3135 483.181, 483.191, 483.201, 483.221, 483.23, 483.245, and 483.26,
3136 is repealed.
3137 Section 98. Section 483.294, Florida Statutes, is amended
3138 to read:
3139 483.294 Inspection of centers.—In accordance with s.
3140 408.811, the agency shall, at least once annually, inspect the
3141 premises and operations of all centers subject to licensure
3142 under this part.
3143 Section 99. Subsections (3) and (5) of section 483.801,
3144 Florida Statutes, are amended, and subsection (6) is added to
3145 that section, to read:
3146 483.801 Exemptions.—This part applies to all clinical
3147 laboratories and clinical laboratory personnel within this
3148 state, except:
3149 (3) Persons engaged in testing performed by laboratories
3150 that are wholly owned and operated by one or more practitioners
3151 licensed under chapter 458, chapter 459, chapter 460, chapter
3152 461, chapter 462, chapter 463, or chapter 466 who practice in
3153 the same group practice, and in which no clinical laboratory
3154 work is performed for patients referred by any health care
3155 provider who is not a member of that group practice regulated
3156 under s. 483.035(1) or exempt from regulation under s.
3157 483.031(2).
3158 (5) Advanced registered nurse practitioners licensed under
3159 part I of chapter 464 who perform provider-performed microscopy
3160 procedures (PPMP) in a an exclusive-use laboratory setting
3161 pursuant to subsection (3).
3162 (6) Persons performing laboratory testing within a
3163 physician office practice for patients referred by a health care
3164 provider who is a member of the same physician office practice,
3165 if the laboratory or entity operating the laboratory within a
3166 physician office practice is under common ownership, directly or
3167 indirectly, with an entity licensed pursuant to chapter 395.
3168 Section 100. Subsections (2), (3), and (4) of section
3169 483.803, Florida Statutes, are amended to read:
3170 483.803 Definitions.—As used in this part, the term:
3171 (2) “Clinical laboratory” means the physical location in
3172 which one or more of the following services are performed to
3173 provide information or materials for use in the diagnosis,
3174 prevention, or treatment of a disease or the identification or
3175 assessment of a medical or physical condition:
3176 (a) Clinical laboratory services, which entail the
3177 examination of fluids or other materials taken from the human
3178 body.
3179 (b) Anatomic laboratory services, which entail the
3180 examination of tissue taken from the human body.
3181 (c) Cytology laboratory services, which entail the
3182 examination of cells from individual tissues or fluid taken from
3183 the human body a clinical laboratory as defined in s. 483.041.
3184 (3) “Clinical laboratory examination” means a procedure
3185 performed to deliver the services identified in subsection (2),
3186 including the oversight or interpretation of such services
3187 clinical laboratory examination as defined in s. 483.041.
3188 (4) “Clinical laboratory personnel” includes a clinical
3189 laboratory director, supervisor, technologist, blood gas
3190 analyst, or technician who performs or is responsible for
3191 laboratory test procedures, but the term does not include
3192 trainees, persons who perform screening for blood banks or
3193 plasmapheresis centers, phlebotomists, or persons employed by a
3194 clinical laboratory to perform manual pretesting duties or
3195 clerical, personnel, or other administrative responsibilities,
3196 or persons engaged in testing performed by laboratories
3197 regulated under s. 483.035(1) or exempt from regulation under s.
3198 483.031(2).
3199 Section 101. Section 483.813, Florida Statutes, is amended
3200 to read:
3201 483.813 Clinical laboratory personnel license.—A person may
3202 not conduct a clinical laboratory examination or report the
3203 results of such examination unless such person is licensed under
3204 this part to perform such procedures. However, this provision
3205 does not apply to any practitioner of the healing arts
3206 authorized to practice in this state or to persons engaged in
3207 testing performed by laboratories regulated under s. 483.035(1)
3208 or exempt from regulation under s. 483.031(2). The department
3209 may grant a temporary license to any candidate it deems properly
3210 qualified, for a period not to exceed 1 year.
3211 Section 102. Subsection (2) of section 483.823, Florida
3212 Statutes, is amended to read:
3213 483.823 Qualifications of clinical laboratory personnel.—
3214 (2) Personnel qualifications may require appropriate
3215 education, training, or experience or the passing of an
3216 examination in appropriate subjects or any combination of these,
3217 but a no practitioner of the healing arts licensed to practice
3218 in this state is not required to obtain any license under this
3219 part or to pay any fee under this part hereunder except the fee
3220 required for clinical laboratory licensure.
3221 Section 103. Paragraph (c) of subsection (7), and
3222 subsections (8) and (9) of section 491.003, Florida Statutes,
3223 are amended to read:
3224 491.003 Definitions.—As used in this chapter:
3225 (7) The “practice of clinical social work” is defined as
3226 the use of scientific and applied knowledge, theories, and
3227 methods for the purpose of describing, preventing, evaluating,
3228 and treating individual, couple, marital, family, or group
3229 behavior, based on the person-in-situation perspective of
3230 psychosocial development, normal and abnormal behavior,
3231 psychopathology, unconscious motivation, interpersonal
3232 relationships, environmental stress, differential assessment,
3233 differential planning, and data gathering. The purpose of such
3234 services is the prevention and treatment of undesired behavior
3235 and enhancement of mental health. The practice of clinical
3236 social work includes methods of a psychological nature used to
3237 evaluate, assess, diagnose, treat, and prevent emotional and
3238 mental disorders and dysfunctions (whether cognitive, affective,
3239 or behavioral), sexual dysfunction, behavioral disorders,
3240 alcoholism, and substance abuse. The practice of clinical social
3241 work includes, but is not limited to, psychotherapy,
3242 hypnotherapy, and sex therapy. The practice of clinical social
3243 work also includes counseling, behavior modification,
3244 consultation, client-centered advocacy, crisis intervention, and
3245 the provision of needed information and education to clients,
3246 when using methods of a psychological nature to evaluate,
3247 assess, diagnose, treat, and prevent emotional and mental
3248 disorders and dysfunctions (whether cognitive, affective, or
3249 behavioral), sexual dysfunction, behavioral disorders,
3250 alcoholism, or substance abuse. The practice of clinical social
3251 work may also include clinical research into more effective
3252 psychotherapeutic modalities for the treatment and prevention of
3253 such conditions.
3254 (c) The terms “diagnose” and “treat,” as used in this
3255 chapter, when considered in isolation or in conjunction with any
3256 provision of the rules of the board, may shall not be construed
3257 to permit the performance of any act which clinical social
3258 workers are not educated and trained to perform, including, but
3259 not limited to, admitting persons to hospitals for treatment of
3260 the foregoing conditions, treating persons in hospitals without
3261 medical supervision, prescribing medicinal drugs as defined in
3262 chapter 465, authorizing clinical laboratory procedures pursuant
3263 to chapter 483, or radiological procedures, or use of
3264 electroconvulsive therapy. In addition, this definition shall
3265 may not be construed to permit any person licensed,
3266 provisionally licensed, registered, or certified pursuant to
3267 this chapter to describe or label any test, report, or procedure
3268 as “psychological,” except to relate specifically to the
3269 definition of practice authorized in this subsection.
3270 (8) The term “practice of marriage and family therapy”
3271 means is defined as the use of scientific and applied marriage
3272 and family theories, methods, and procedures for the purpose of
3273 describing, evaluating, and modifying marital, family, and
3274 individual behavior, within the context of marital and family
3275 systems, including the context of marital formation and
3276 dissolution, and is based on marriage and family systems theory,
3277 marriage and family development, human development, normal and
3278 abnormal behavior, psychopathology, human sexuality,
3279 psychotherapeutic and marriage and family therapy theories and
3280 techniques. The practice of marriage and family therapy includes
3281 methods of a psychological nature used to evaluate, assess,
3282 diagnose, treat, and prevent emotional and mental disorders or
3283 dysfunctions (whether cognitive, affective, or behavioral),
3284 sexual dysfunction, behavioral disorders, alcoholism, and
3285 substance abuse. The practice of marriage and family therapy
3286 includes, but is not limited to, marriage and family therapy,
3287 psychotherapy, including behavioral family therapy,
3288 hypnotherapy, and sex therapy. The practice of marriage and
3289 family therapy also includes counseling, behavior modification,
3290 consultation, client-centered advocacy, crisis intervention, and
3291 the provision of needed information and education to clients,
3292 when using methods of a psychological nature to evaluate,
3293 assess, diagnose, treat, and prevent emotional and mental
3294 disorders and dysfunctions (whether cognitive, affective, or
3295 behavioral), sexual dysfunction, behavioral disorders,
3296 alcoholism, or substance abuse. The practice of marriage and
3297 family therapy may also include clinical research into more
3298 effective psychotherapeutic modalities for the treatment and
3299 prevention of such conditions.
3300 (a) Marriage and family therapy may be rendered to
3301 individuals, including individuals affected by termination of
3302 marriage, to couples, whether married or unmarried, to families,
3303 or to groups.
3304 (b) The use of specific methods, techniques, or modalities
3305 within the practice of marriage and family therapy is restricted
3306 to marriage and family therapists appropriately trained in the
3307 use of such methods, techniques, or modalities.
3308 (c) The terms “diagnose” and “treat,” as used in this
3309 chapter, when considered in isolation or in conjunction with any
3310 provision of the rules of the board, may shall not be construed
3311 to permit the performance of any act that which marriage and
3312 family therapists are not educated and trained to perform,
3313 including, but not limited to, admitting persons to hospitals
3314 for treatment of the foregoing conditions, treating persons in
3315 hospitals without medical supervision, prescribing medicinal
3316 drugs as defined in chapter 465, authorizing clinical laboratory
3317 procedures pursuant to chapter 483, or radiological procedures,
3318 or the use of electroconvulsive therapy. In addition, this
3319 definition may shall not be construed to permit any person
3320 licensed, provisionally licensed, registered, or certified
3321 pursuant to this chapter to describe or label any test, report,
3322 or procedure as “psychological,” except to relate specifically
3323 to the definition of practice authorized in this subsection.
3324 (d) The definition of “marriage and family therapy”
3325 contained in this subsection includes all services offered
3326 directly to the general public or through organizations, whether
3327 public or private, and applies whether payment is requested or
3328 received for services rendered.
3329 (9) The term “practice of mental health counseling” means
3330 is defined as the use of scientific and applied behavioral
3331 science theories, methods, and techniques for the purpose of
3332 describing, preventing, and treating undesired behavior and
3333 enhancing mental health and human development and is based on
3334 the person-in-situation perspectives derived from research and
3335 theory in personality, family, group, and organizational
3336 dynamics and development, career planning, cultural diversity,
3337 human growth and development, human sexuality, normal and
3338 abnormal behavior, psychopathology, psychotherapy, and
3339 rehabilitation. The practice of mental health counseling
3340 includes methods of a psychological nature used to evaluate,
3341 assess, diagnose, and treat emotional and mental dysfunctions or
3342 disorders, (whether cognitive, affective, or behavioral),
3343 behavioral disorders, interpersonal relationships, sexual
3344 dysfunction, alcoholism, and substance abuse. The practice of
3345 mental health counseling includes, but is not limited to,
3346 psychotherapy, hypnotherapy, and sex therapy. The practice of
3347 mental health counseling also includes counseling, behavior
3348 modification, consultation, client-centered advocacy, crisis
3349 intervention, and the provision of needed information and
3350 education to clients, when using methods of a psychological
3351 nature to evaluate, assess, diagnose, treat, and prevent
3352 emotional and mental disorders and dysfunctions (whether
3353 cognitive, affective, or behavioral), behavioral disorders,
3354 sexual dysfunction, alcoholism, or substance abuse. The practice
3355 of mental health counseling may also include clinical research
3356 into more effective psychotherapeutic modalities for the
3357 treatment and prevention of such conditions.
3358 (a) Mental health counseling may be rendered to
3359 individuals, including individuals affected by the termination
3360 of marriage, and to couples, families, groups, organizations,
3361 and communities.
3362 (b) The use of specific methods, techniques, or modalities
3363 within the practice of mental health counseling is restricted to
3364 mental health counselors appropriately trained in the use of
3365 such methods, techniques, or modalities.
3366 (c) The terms “diagnose” and “treat,” as used in this
3367 chapter, when considered in isolation or in conjunction with any
3368 provision of the rules of the board, may shall not be construed
3369 to permit the performance of any act that which mental health
3370 counselors are not educated and trained to perform, including,
3371 but not limited to, admitting persons to hospitals for treatment
3372 of the foregoing conditions, treating persons in hospitals
3373 without medical supervision, prescribing medicinal drugs as
3374 defined in chapter 465, authorizing clinical laboratory
3375 procedures pursuant to chapter 483, or radiological procedures,
3376 or the use of electroconvulsive therapy. In addition, this
3377 definition may shall not be construed to permit any person
3378 licensed, provisionally licensed, registered, or certified
3379 pursuant to this chapter to describe or label any test, report,
3380 or procedure as “psychological,” except to relate specifically
3381 to the definition of practice authorized in this subsection.
3382 (d) The definition of “mental health counseling” contained
3383 in this subsection includes all services offered directly to the
3384 general public or through organizations, whether public or
3385 private, and applies whether payment is requested or received
3386 for services rendered.
3387 Section 104. Paragraph (h) of subsection (4) of section
3388 627.351, Florida Statutes, is amended to read:
3389 627.351 Insurance risk apportionment plans.—
3390 (4) MEDICAL MALPRACTICE RISK APPORTIONMENT.—
3391 (h) As used in this subsection:
3392 1. “Health care provider” means hospitals licensed under
3393 chapter 395; physicians licensed under chapter 458; osteopathic
3394 physicians licensed under chapter 459; podiatric physicians
3395 licensed under chapter 461; dentists licensed under chapter 466;
3396 chiropractic physicians licensed under chapter 460; naturopaths
3397 licensed under chapter 462; nurses licensed under part I of
3398 chapter 464; midwives licensed under chapter 467; clinical
3399 laboratories registered under chapter 483; physician assistants
3400 licensed under chapter 458 or chapter 459; physical therapists
3401 and physical therapist assistants licensed under chapter 486;
3402 health maintenance organizations certificated under part I of
3403 chapter 641; ambulatory surgical centers licensed under chapter
3404 395; other medical facilities as defined in subparagraph 2.;
3405 blood banks, plasma centers, industrial clinics, and renal
3406 dialysis facilities; or professional associations, partnerships,
3407 corporations, joint ventures, or other associations for
3408 professional activity by health care providers.
3409 2. “Other medical facility” means a facility the primary
3410 purpose of which is to provide human medical diagnostic services
3411 or a facility providing nonsurgical human medical treatment, to
3412 which facility the patient is admitted and from which facility
3413 the patient is discharged within the same working day, and which
3414 facility is not part of a hospital. However, a facility existing
3415 for the primary purpose of performing terminations of pregnancy
3416 or an office maintained by a physician or dentist for the
3417 practice of medicine may shall not be construed to be an “other
3418 medical facility.”
3419 3. “Health care facility” means any hospital licensed under
3420 chapter 395, health maintenance organization certificated under
3421 part I of chapter 641, ambulatory surgical center licensed under
3422 chapter 395, or other medical facility as defined in
3423 subparagraph 2.
3424 Section 105. Paragraph (h) of subsection (1) of section
3425 627.602, Florida Statutes, is amended to read:
3426 627.602 Scope, format of policy.—
3427 (1) Each health insurance policy delivered or issued for
3428 delivery to any person in this state must comply with all
3429 applicable provisions of this code and all of the following
3430 requirements:
3431 (h) Section 641.312 and the provisions of the Employee
3432 Retirement Income Security Act of 1974, as implemented by 29
3433 C.F.R. s. 2560.503-1, relating to internal grievances. This
3434 paragraph does not apply to a health insurance policy that is
3435 subject to the Subscriber Assistance Program under s. 408.7056
3436 or to the types of benefits or coverages provided under s.
3437 627.6513(1)-(14) issued in any market.
3438 Section 106. Subsection (1) of section 627.6406, Florida
3439 Statutes, is amended to read:
3440 627.6406 Maternity care.—
3441 (1) Any policy of health insurance which that provides
3442 coverage for maternity care must also cover the services of
3443 certified nurse-midwives and midwives licensed pursuant to
3444 chapter 467, and the services of birth centers licensed under
3445 ss. 383.30-383.332 383.30-383.335.
3446 Section 107. Paragraphs (b) and (e) of subsection (1) of
3447 section 627.64194, Florida Statutes, are amended to read:
3448 627.64194 Coverage requirements for services provided by
3449 nonparticipating providers; payment collection limitations.—
3450 (1) As used in this section, the term:
3451 (b) “Facility” means a licensed facility as defined in s.
3452 395.002(16) and an urgent care center as defined in s. 395.002
3453 s. 395.002(30).
3454 (e) “Nonparticipating provider” means a provider who is not
3455 a preferred provider as defined in s. 627.6471 or a provider who
3456 is not an exclusive provider as defined in s. 627.6472. For
3457 purposes of covered emergency services under this section, a
3458 facility licensed under chapter 395 or an urgent care center
3459 defined in s. 395.002 s. 395.002(30) is a nonparticipating
3460 provider if the facility has not contracted with an insurer to
3461 provide emergency services to its insureds at a specified rate.
3462 Section 108. Section 627.6513, Florida Statutes, is amended
3463 to read:
3464 627.6513 Scope.—Section 641.312 and the provisions of the
3465 Employee Retirement Income Security Act of 1974, as implemented
3466 by 29 C.F.R. s. 2560.503-1, relating to internal grievances,
3467 apply to all group health insurance policies issued under this
3468 part. This section does not apply to a group health insurance
3469 policy that is subject to the Subscriber Assistance Program in
3470 s. 408.7056 or to:
3471 (1) Coverage only for accident insurance, or disability
3472 income insurance, or any combination thereof.
3473 (2) Coverage issued as a supplement to liability insurance.
3474 (3) Liability insurance, including general liability
3475 insurance and automobile liability insurance.
3476 (4) Workers’ compensation or similar insurance.
3477 (5) Automobile medical payment insurance.
3478 (6) Credit-only insurance.
3479 (7) Coverage for onsite medical clinics, including prepaid
3480 health clinics under part II of chapter 641.
3481 (8) Other similar insurance coverage, specified in rules
3482 adopted by the commission, under which benefits for medical care
3483 are secondary or incidental to other insurance benefits. To the
3484 extent possible, such rules must be consistent with regulations
3485 adopted by the United States Department of Health and Human
3486 Services.
3487 (9) Limited scope dental or vision benefits, if offered
3488 separately.
3489 (10) Benefits for long-term care, nursing home care, home
3490 health care, or community-based care, or any combination
3491 thereof, if offered separately.
3492 (11) Other similar, limited benefits, if offered
3493 separately, as specified in rules adopted by the commission.
3494 (12) Coverage only for a specified disease or illness, if
3495 offered as independent, noncoordinated benefits.
3496 (13) Hospital indemnity or other fixed indemnity insurance,
3497 if offered as independent, noncoordinated benefits.
3498 (14) Benefits provided through a Medicare supplemental
3499 health insurance policy, as defined under s. 1882(g)(1) of the
3500 Social Security Act, coverage supplemental to the coverage
3501 provided under 10 U.S.C. chapter 55, and similar supplemental
3502 coverage provided to coverage under a group health plan, which
3503 are offered as a separate insurance policy and as independent,
3504 noncoordinated benefits.
3505 Section 109. Subsection (1) of section 627.6574, Florida
3506 Statutes, is amended to read:
3507 627.6574 Maternity care.—
3508 (1) Any group, blanket, or franchise policy of health
3509 insurance which that provides coverage for maternity care must
3510 also cover the services of certified nurse-midwives and midwives
3511 licensed pursuant to chapter 467, and the services of birth
3512 centers licensed under ss. 383.30-383.332 383.30-383.335.
3513 Section 110. Paragraph (j) of subsection (1) of section
3514 641.185, Florida Statutes, is amended to read:
3515 641.185 Health maintenance organization subscriber
3516 protections.—
3517 (1) With respect to the provisions of this part and part
3518 III, the principles expressed in the following statements shall
3519 serve as standards to be followed by the commission, the office,
3520 the department, and the Agency for Health Care Administration in
3521 exercising their powers and duties, in exercising administrative
3522 discretion, in administrative interpretations of the law, in
3523 enforcing its provisions, and in adopting rules:
3524 (j) A health maintenance organization should receive timely
3525 and, if necessary, urgent review by an independent state
3526 external review organization for unresolved grievances and
3527 appeals pursuant to s. 408.7056.
3528 Section 111. Paragraph (a) of subsection (18) of section
3529 641.31, Florida Statutes, is amended to read:
3530 641.31 Health maintenance contracts.—
3531 (18)(a) Health maintenance contracts that provide coverage,
3532 benefits, or services for maternity care must provide, as an
3533 option to the subscriber, the services of nurse-midwives and
3534 midwives licensed pursuant to chapter 467, and the services of
3535 birth centers licensed pursuant to ss. 383.30-383.332 383.30
3536 383.335, if such services are available within the service area.
3537 Section 112. Section 641.312, Florida Statutes, is amended
3538 to read:
3539 641.312 Scope.—The Office of Insurance Regulation may adopt
3540 rules to administer the provisions of the National Association
3541 of Insurance Commissioners’ Uniform Health Carrier External
3542 Review Model Act, issued by the National Association of
3543 Insurance Commissioners and dated April 2010. This section does
3544 not apply to a health maintenance contract that is subject to
3545 the Subscriber Assistance Program under s. 408.7056 or to the
3546 types of benefits or coverages provided under s. 627.6513(1)
3547 (14) issued in any market.
3548 Section 113. Subsection (4) of section 641.3154, Florida
3549 Statutes, is amended to read:
3550 641.3154 Organization liability; provider billing
3551 prohibited.—
3552 (4) A provider or any representative of a provider,
3553 regardless of whether the provider is under contract with the
3554 health maintenance organization, may not collect or attempt to
3555 collect money from, maintain any action at law against, or
3556 report to a credit agency a subscriber of an organization for
3557 payment of services for which the organization is liable, if the
3558 provider in good faith knows or should know that the
3559 organization is liable. This prohibition applies during the
3560 pendency of any claim for payment made by the provider to the
3561 organization for payment of the services and any legal
3562 proceedings or dispute resolution process to determine whether
3563 the organization is liable for the services if the provider is
3564 informed that such proceedings are taking place. It is presumed
3565 that a provider does not know and should not know that an
3566 organization is liable unless:
3567 (a) The provider is informed by the organization that it
3568 accepts liability;
3569 (b) A court of competent jurisdiction determines that the
3570 organization is liable; or
3571 (c) The office or agency makes a final determination that
3572 the organization is required to pay for such services subsequent
3573 to a recommendation made by the Subscriber Assistance Panel
3574 pursuant to s. 408.7056; or
3575 (c)(d) The agency issues a final order that the
3576 organization is required to pay for such services subsequent to
3577 a recommendation made by a resolution organization pursuant to
3578 s. 408.7057.
3579 Section 114. Paragraph (c) of subsection (5) of section
3580 641.51, Florida Statutes, is amended to read:
3581 641.51 Quality assurance program; second medical opinion
3582 requirement.—
3583 (5)(c) For second opinions provided by contract physicians
3584 the organization is prohibited from charging a fee to the
3585 subscriber in an amount in excess of the subscriber fees
3586 established by contract for referral contract physicians. The
3587 organization shall pay the amount of all charges, which are
3588 usual, reasonable, and customary in the community, for second
3589 opinion services performed by a physician not under contract
3590 with the organization, but may require the subscriber to be
3591 responsible for up to 40 percent of such amount. The
3592 organization may require that any tests deemed necessary by a
3593 noncontract physician shall be conducted by the organization.
3594 The organization may deny reimbursement rights granted under
3595 this section in the event the subscriber seeks in excess of
3596 three such referrals per year if such subsequent referral costs
3597 are deemed by the organization to be evidence that the
3598 subscriber has unreasonably overutilized the second opinion
3599 privilege. A subscriber thus denied reimbursement under this
3600 section has shall have recourse to grievance procedures as
3601 specified in ss. 408.7056, 641.495, and 641.511. The
3602 organization’s physician’s professional judgment concerning the
3603 treatment of a subscriber derived after review of a second
3604 opinion is shall be controlling as to the treatment obligations
3605 of the health maintenance organization. Treatment not authorized
3606 by the health maintenance organization is shall be at the
3607 subscriber’s expense.
3608 Section 115. Subsection (1), paragraph (e) of subsection
3609 (3), paragraph (d) of subsection (4), paragraphs (g) and (h) of
3610 subsection (6), and subsections (7) through (12) of section
3611 641.511, Florida Statutes, are amended to read:
3612 641.511 Subscriber grievance reporting and resolution
3613 requirements.—
3614 (1) Every organization must have a grievance procedure
3615 available to its subscribers for the purpose of addressing
3616 complaints and grievances. Every organization must notify its
3617 subscribers that a subscriber must submit a grievance within 1
3618 year after the date of occurrence of the action that initiated
3619 the grievance, and may submit the grievance for review to the
3620 Subscriber Assistance Program panel as provided in s. 408.7056
3621 after receiving a final disposition of the grievance through the
3622 organization’s grievance process. An organization shall maintain
3623 records of all grievances and shall report annually to the
3624 agency the total number of grievances handled, a categorization
3625 of the cases underlying the grievances, and the final
3626 disposition of the grievances.
3627 (3) Each organization’s grievance procedure, as required
3628 under subsection (1), must include, at a minimum:
3629 (e) A notice that a subscriber may voluntarily pursue
3630 binding arbitration in accordance with the terms of the contract
3631 if offered by the organization, after completing the
3632 organization’s grievance procedure and as an alternative to the
3633 Subscriber Assistance Program. Such notice shall include an
3634 explanation that the subscriber may incur some costs if the
3635 subscriber pursues binding arbitration, depending upon the terms
3636 of the subscriber’s contract.
3637 (4)
3638 (d) In any case when the review process does not resolve a
3639 difference of opinion between the organization and the
3640 subscriber or the provider acting on behalf of the subscriber,
3641 the subscriber or the provider acting on behalf of the
3642 subscriber may submit a written grievance to the Subscriber
3643 Assistance Program.
3644 (6)
3645 (g) In any case when the expedited review process does not
3646 resolve a difference of opinion between the organization and the
3647 subscriber or the provider acting on behalf of the subscriber,
3648 the subscriber or the provider acting on behalf of the
3649 subscriber may submit a written grievance to the Subscriber
3650 Assistance Program.
3651 (g)(h) An organization shall not provide an expedited
3652 retrospective review of an adverse determination.
3653 (7) Each organization shall send to the agency a copy of
3654 its quarterly grievance reports submitted to the office pursuant
3655 to s. 408.7056(12).
3656 (7)(8) The agency shall investigate all reports of
3657 unresolved quality of care grievances received from:
3658 (a) annual and quarterly grievance reports submitted by the
3659 organization to the office.
3660 (b) Review requests of subscribers whose grievances remain
3661 unresolved after the subscriber has followed the full grievance
3662 procedure of the organization.
3663 (9)(a) The agency shall advise subscribers with grievances
3664 to follow their organization’s formal grievance process for
3665 resolution prior to review by the Subscriber Assistance Program.
3666 The subscriber may, however, submit a copy of the grievance to
3667 the agency at any time during the process.
3668 (b) Requiring completion of the organization’s grievance
3669 process before the Subscriber Assistance Program panel’s review
3670 does not preclude the agency from investigating any complaint or
3671 grievance before the organization makes its final determination.
3672 (10) Each organization must notify the subscriber in a
3673 final decision letter that the subscriber may request review of
3674 the organization’s decision concerning the grievance by the
3675 Subscriber Assistance Program, as provided in s. 408.7056, if
3676 the grievance is not resolved to the satisfaction of the
3677 subscriber. The final decision letter must inform the subscriber
3678 that the request for review must be made within 365 days after
3679 receipt of the final decision letter, must explain how to
3680 initiate such a review, and must include the addresses and toll
3681 free telephone numbers of the agency and the Subscriber
3682 Assistance Program.
3683 (8)(11) Each organization, as part of its contract with any
3684 provider, must require the provider to post a consumer
3685 assistance notice prominently displayed in the reception area of
3686 the provider and clearly noticeable by all patients. The
3687 consumer assistance notice must state the addresses and toll
3688 free telephone numbers of the Agency for Health Care
3689 Administration, the Subscriber Assistance Program, and the
3690 Department of Financial Services. The consumer assistance notice
3691 must also clearly state that the address and toll-free telephone
3692 number of the organization’s grievance department shall be
3693 provided upon request. The agency may adopt rules to implement
3694 this section.
3695 (9)(12) The agency may impose administrative sanction, in
3696 accordance with s. 641.52, against an organization for
3697 noncompliance with this section.
3698 Section 116. Subsection (1) of section 641.515, Florida
3699 Statutes, is amended to read:
3700 641.515 Investigation by the agency.—
3701 (1) The agency shall investigate further any quality of
3702 care issue contained in recommendations and reports submitted
3703 pursuant to s. ss. 408.7056 and 641.511. The agency shall also
3704 investigate further any information that indicates that the
3705 organization does not meet accreditation standards or the
3706 standards of the review organization performing the external
3707 quality assurance assessment pursuant to reports submitted under
3708 s. 641.512. Every organization shall submit its books and
3709 records and take other appropriate action as may be necessary to
3710 facilitate an examination. The agency shall have access to the
3711 organization’s medical records of individuals and records of
3712 employed and contracted physicians, with the consent of the
3713 subscriber or by court order, as necessary to administer carry
3714 out the provisions of this part.
3715 Section 117. Subsection (2) of section 641.55, Florida
3716 Statutes, is amended to read:
3717 641.55 Internal risk management program.—
3718 (2) The risk management program shall be the responsibility
3719 of the governing authority or board of the organization. Every
3720 organization which has an annual premium volume of $10 million
3721 or more and which directly provides health care in a building
3722 owned or leased by the organization shall hire a risk manager,
3723 certified under ss. 395.10971-395.10975, who is shall be
3724 responsible for implementation of the organization’s risk
3725 management program required by this section. A part-time risk
3726 manager may shall not be responsible for risk management
3727 programs in more than four organizations or facilities. Every
3728 organization that which does not directly provide health care in
3729 a building owned or leased by the organization and every
3730 organization with an annual premium volume of less than $10
3731 million shall designate an officer or employee of the
3732 organization to serve as the risk manager.
3733
3734 The gross data compiled under this section or s. 395.0197 shall
3735 be furnished by the agency upon request to organizations to be
3736 utilized for risk management purposes. The agency shall adopt
3737 rules necessary to administer carry out the provisions of this
3738 section.
3739 Section 118. Section 641.60, Florida Statutes, is repealed.
3740 Section 119. Section 641.65, Florida Statutes, is repealed.
3741 Section 120. Section 641.67, Florida Statutes, is repealed.
3742 Section 121. Section 641.68, Florida Statutes, is repealed.
3743 Section 122. Section 641.70, Florida Statutes, is repealed.
3744 Section 123. Section 641.75, Florida Statutes, is repealed.
3745 Section 124. Paragraph (b) of subsection (6) of section
3746 766.118, Florida Statutes, is amended to read:
3747 766.118 Determination of noneconomic damages.—
3748 (6) LIMITATION ON NONECONOMIC DAMAGES FOR NEGLIGENCE OF A
3749 PRACTITIONER PROVIDING SERVICES AND CARE TO A MEDICAID
3750 RECIPIENT.—Notwithstanding subsections (2), (3), and (5), with
3751 respect to a cause of action for personal injury or wrongful
3752 death arising from medical negligence of a practitioner
3753 committed in the course of providing medical services and
3754 medical care to a Medicaid recipient, regardless of the number
3755 of such practitioner defendants providing the services and care,
3756 noneconomic damages may not exceed $300,000 per claimant, unless
3757 the claimant pleads and proves, by clear and convincing
3758 evidence, that the practitioner acted in a wrongful manner. A
3759 practitioner providing medical services and medical care to a
3760 Medicaid recipient is not liable for more than $200,000 in
3761 noneconomic damages, regardless of the number of claimants,
3762 unless the claimant pleads and proves, by clear and convincing
3763 evidence, that the practitioner acted in a wrongful manner. The
3764 fact that a claimant proves that a practitioner acted in a
3765 wrongful manner does not preclude the application of the
3766 limitation on noneconomic damages prescribed elsewhere in this
3767 section. For purposes of this subsection:
3768 (b) The term “practitioner,” in addition to the meaning
3769 prescribed in subsection (1), includes any hospital or,
3770 ambulatory surgical center, or mobile surgical facility as
3771 defined and licensed under chapter 395.
3772 Section 125. Subsection (4) of section 766.202, Florida
3773 Statutes, is amended to read:
3774 766.202 Definitions; ss. 766.201-766.212.—As used in ss.
3775 766.201-766.212, the term:
3776 (4) “Health care provider” means any hospital or,
3777 ambulatory surgical center, or mobile surgical facility as
3778 defined and licensed under chapter 395; a birth center licensed
3779 under chapter 383; any person licensed under chapter 458,
3780 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
3781 part I of chapter 464, chapter 466, chapter 467, part XIV of
3782 chapter 468, or chapter 486; a clinical lab licensed under
3783 chapter 483; a health maintenance organization certificated
3784 under part I of chapter 641; a blood bank; a plasma center; an
3785 industrial clinic; a renal dialysis facility; or a professional
3786 association partnership, corporation, joint venture, or other
3787 association for professional activity by health care providers.
3788 Section 126. Section 945.36, Florida Statutes, is amended
3789 to read:
3790 945.36 Exemption from health testing regulations for Law
3791 enforcement personnel authorized to conduct conducting drug
3792 tests on inmates and releasees.—
3793 (1) Any law enforcement officer, state or county probation
3794 officer, employee of the Department of Corrections, or employee
3795 of a contracted community correctional center who is certified
3796 by the Department of Corrections pursuant to subsection (2) may
3797 administer, is exempt from part I of chapter 483, for the
3798 limited purpose of administering a urine screen drug test to:
3799 (a) Persons during incarceration;
3800 (b) Persons released as a condition of probation for either
3801 a felony or misdemeanor;
3802 (c) Persons released as a condition of community control;
3803 (d) Persons released as a condition of conditional release;
3804 (e) Persons released as a condition of parole;
3805 (f) Persons released as a condition of provisional release;
3806 (g) Persons released as a condition of pretrial release; or
3807 (h) Persons released as a condition of control release.
3808 (2) The Department of Corrections shall develop a procedure
3809 for certification of any law enforcement officer, state or
3810 county probation officer, employee of the Department of
3811 Corrections, or employee of a contracted community correctional
3812 center to perform a urine screen drug test on the persons
3813 specified in subsection (1).
3814 Section 127. Paragraph (b) of subsection (2) of section
3815 1009.65, Florida Statutes, is amended to read:
3816 1009.65 Medical Education Reimbursement and Loan Repayment
3817 Program.—
3818 (2) From the funds available, the Department of Health
3819 shall make payments to selected medical professionals as
3820 follows:
3821 (b) All payments are shall be contingent on continued proof
3822 of primary care practice in an area defined in s. 395.602(2)(b)
3823 s. 395.602(2)(e), or an underserved area designated by the
3824 Department of Health, provided the practitioner accepts Medicaid
3825 reimbursement if eligible for such reimbursement. Correctional
3826 facilities, state hospitals, and other state institutions that
3827 employ medical personnel shall be designated by the Department
3828 of Health as underserved locations. Locations with high
3829 incidences of infant mortality, high morbidity, or low Medicaid
3830 participation by health care professionals may be designated as
3831 underserved.
3832 Section 128. Subsection (2) of section 1011.52, Florida
3833 Statutes, is amended to read:
3834 1011.52 Appropriation to first accredited medical school.—
3835 (2) In order for a medical school to qualify under the
3836 provisions of this section and to be entitled to the benefits
3837 herein, such medical school:
3838 (a) Must be primarily operated and established to offer,
3839 afford, and render a medical education to residents of the state
3840 qualifying for admission to such institution;
3841 (b) Must be operated by a municipality or county of this
3842 state, or by a nonprofit organization heretofore or hereafter
3843 established exclusively for educational purposes;
3844 (c) Must, upon the formation and establishment of an
3845 accredited medical school, transmit and file with the Department
3846 of Education documentary proof evidencing the facts that such
3847 institution has been certified and approved by the council on
3848 medical education and hospitals of the American Medical
3849 Association and has adequately met the requirements of that
3850 council in regard to its administrative facilities,
3851 administrative plant, clinical facilities, curriculum, and all
3852 other such requirements as may be necessary to qualify with the
3853 council as a recognized, approved, and accredited medical
3854 school;
3855 (d) Must certify to the Department of Education the name,
3856 address, and educational history of each student approved and
3857 accepted for enrollment in such institution for the ensuing
3858 school year; and
3859 (e) Must have in place an operating agreement with a
3860 government-owned hospital that is located in the same county as
3861 the medical school and that is a statutory teaching hospital as
3862 defined in s. 408.07(44) s. 408.07(45). The operating agreement
3863 must shall provide for the medical school to maintain the same
3864 level of affiliation with the hospital, including the level of
3865 services to indigent and charity care patients served by the
3866 hospital, which was in place in the prior fiscal year. Each
3867 year, documentation demonstrating that an operating agreement is
3868 in effect shall be submitted jointly to the Department of
3869 Education by the hospital and the medical school prior to the
3870 payment of moneys from the annual appropriation.
3871 Section 129. This act shall take effect July 1, 2018.
