1 | A bill to be entitled |
2 | An act relating to health care; amending s. 112.0455, |
3 | F.S., relating to the Drug-Free Workplace Act; deleting an |
4 | obsolete provision; amending s. 318.21, F.S.; revising |
5 | distribution of funds from civil penalties imposed for |
6 | traffic infractions by county courts; amending s. |
7 | 381.00315, F.S.; directing the Department of Health to |
8 | accept funds from counties, municipalities, and certain |
9 | other entities for the purchase of certain products made |
10 | available under a contract of the United States Department |
11 | of Health and Human Services for the manufacture and |
12 | delivery of such products in response to a public health |
13 | emergency; amending s. 381.0072, F.S.; limiting Department |
14 | of Health food service inspections in nursing homes; |
15 | requiring the department to coordinate inspections with |
16 | the Agency for Health Care Administration; repealing s. |
17 | 383.325, F.S., relating to confidentiality of inspection |
18 | reports of licensed birth center facilities; amending s. |
19 | 395.002, F.S.; revising and deleting definitions |
20 | applicable to regulation of hospitals and other licensed |
21 | facilities; conforming a cross-reference; amending s. |
22 | 395.003, F.S.; deleting an obsolete provision; conforming |
23 | a cross-reference; amending s. 395.0193, F.S.; requiring a |
24 | licensed facility to report certain peer review |
25 | information and final disciplinary actions to the Division |
26 | of Medical Quality Assurance of the Department of Health |
27 | rather than the Division of Health Quality Assurance of |
28 | the Agency for Health Care Administration; amending s. |
29 | 395.1023, F.S.; providing for the Department of Children |
30 | and Family Services rather than the Department of Health |
31 | to perform certain functions with respect to child |
32 | protection cases; requiring certain hospitals to notify |
33 | the Department of Children and Family Services of |
34 | compliance; amending s. 395.1041, F.S., relating to |
35 | hospital emergency services and care; deleting obsolete |
36 | provisions; repealing s. 395.1046, F.S., relating to |
37 | complaint investigation procedures; amending s. 395.1055, |
38 | F.S.; requiring licensed facility beds to conform to |
39 | standards specified by the Agency for Health Care |
40 | Administration, the Florida Building Code, and the Florida |
41 | Fire Prevention Code; amending s. 395.10972, F.S.; |
42 | revising a reference to the Florida Society of Healthcare |
43 | Risk Management to conform to the current designation; |
44 | amending s. 395.2050, F.S.; revising a reference to the |
45 | federal Health Care Financing Administration to conform to |
46 | the current designation; amending s. 395.3036, F.S.; |
47 | correcting a reference; repealing s. 395.3037, F.S., |
48 | relating to redundant definitions; amending ss. 154.11, |
49 | 394.741, 395.3038, 400.925, 400.9935, 408.05, 440.13, |
50 | 627.645, 627.668, 627.669, 627.736, 641.495, and 766.1015, |
51 | F.S.; revising references to the Joint Commission on |
52 | Accreditation of Healthcare Organizations, the Commission |
53 | on Accreditation of Rehabilitation Facilities, and the |
54 | Council on Accreditation to conform to their current |
55 | designations; amending s. 395.602, F.S.; revising the |
56 | definition of the term "rural hospital" to delete an |
57 | obsolete provision; amending s. 400.021, F.S.; revising |
58 | the definition of the term "geriatric outpatient clinic"; |
59 | amending s. 400.0255, F.S.; correcting an obsolete cross- |
60 | reference to administrative rules; amending s. 400.063, |
61 | F.S.; deleting an obsolete provision; amending ss. 400.071 |
62 | and 400.0712, F.S.; revising applicability of general |
63 | licensure requirements under part II of ch. 408, F.S., to |
64 | applications for nursing home licensure; revising |
65 | provisions governing inactive licenses; amending s. |
66 | 400.111, F.S.; providing for disclosure of controlling |
67 | interest of a nursing home facility upon request by the |
68 | Agency for Health Care Administration; amending s. |
69 | 400.1183, F.S.; revising grievance record maintenance and |
70 | reporting requirements for nursing homes; amending s. |
71 | 400.141, F.S.; providing criteria for the provision of |
72 | respite services by nursing homes; requiring a written |
73 | plan of care; requiring a contract for services; requiring |
74 | resident release to caregivers to be designated in |
75 | writing; providing an exemption to the application of |
76 | discharge planning rules; providing for residents' rights; |
77 | providing for use of personal medications; providing terms |
78 | of respite stay; providing for communication of patient |
79 | information; requiring a physician order for care and |
80 | proof of a physical examination; providing for services |
81 | for respite patients and duties of facilities with respect |
82 | to such patients; conforming a cross-reference; requiring |
83 | facilities to maintain clinical records that meet |
84 | specified standards; providing a fine relating to an |
85 | admissions moratorium; deleting requirement for facilities |
86 | to submit certain information related to management |
87 | companies to the agency; deleting a requirement for |
88 | facilities to notify the agency of certain bankruptcy |
89 | filings to conform to changes made by the act; amending s. |
90 | 400.142, F.S.; deleting language relating to agency |
91 | adoption of rules; amending 400.147, F.S.; revising |
92 | reporting requirements for licensed nursing home |
93 | facilities relating to adverse incidents; repealing s. |
94 | 400.148, F.S., relating to the Medicaid "Up-or-Out" |
95 | Quality of Care Contract Management Program; amending s. |
96 | 400.162, F.S., requiring nursing homes to provide a |
97 | resident property statement annually and upon request; |
98 | amending s. 400.179, F.S.; revising requirements for |
99 | nursing home lease bond alternative fees; deleting an |
100 | obsolete provision; amending s. 400.19, F.S.; revising |
101 | inspection requirements; repealing s. 400.195, F.S., |
102 | relating to agency reporting requirements; amending s. |
103 | 400.23, F.S.; deleting an obsolete provision; correcting a |
104 | reference; directing the agency to adopt rules for minimum |
105 | staffing standards in nursing homes that serve persons |
106 | under 21 years of age; providing minimum staffing |
107 | standards; amending s. 400.275, F.S.; revising agency |
108 | duties with regard to training nursing home surveyor |
109 | teams; revising requirements for team members; amending s. |
110 | 400.484, F.S.; revising the schedule of home health agency |
111 | inspection violations; amending s. 400.606, F.S.; revising |
112 | the content requirements of the plan accompanying an |
113 | initial or change-of-ownership application for licensure |
114 | of a hospice; revising requirements relating to |
115 | certificates of need for certain hospice facilities; |
116 | amending s. 400.607, F.S.; revising grounds for agency |
117 | action against a hospice; amending s. 400.915, F.S.; |
118 | correcting an obsolete cross-reference to administrative |
119 | rules; amending s. 400.931, F.S.; deleting a requirement |
120 | that an applicant for a home medical equipment provider |
121 | license submit a surety bond to the agency; amending s. |
122 | 400.932, F.S.; revising grounds for the imposition of |
123 | administrative penalties for certain violations by an |
124 | employee of a home medical equipment provider; amending s. |
125 | 400.967, F.S.; revising the schedule of inspection |
126 | violations for intermediate care facilities for the |
127 | developmentally disabled; providing a penalty for certain |
128 | violations; amending s. 400.9905, F.S.; providing that |
129 | part X of ch, 400, F.S., the Health Care Clinic Act, does |
130 | not apply to an entity owned by a corporation with a |
131 | specified amount of annual sales of health care services |
132 | under certain circumstances or to an entity owned or |
133 | controlled by a publicly traded entity with a specified |
134 | amount of annual revenues; amending s. 400.991, F.S.; |
135 | conforming terminology; revising application requirements |
136 | relating to documentation of financial ability to operate |
137 | a mobile clinic; amending s. 408.034, F.S.; revising |
138 | agency authority relating to licensing of intermediate |
139 | care facilities for the developmentally disabled; amending |
140 | s. 408.036, F.S.; deleting an exemption from certain |
141 | certificate-of-need review requirements for a hospice or a |
142 | hospice inpatient facility; amending s. 408.043, F.S.; |
143 | revising requirements for certain freestanding inpatient |
144 | hospice care facilities to obtain a certificate of need; |
145 | amending s. 408.061, F.S.; revising health care facility |
146 | data reporting requirements; amending s. 408.10, F.S.; |
147 | removing agency authority to investigate certain consumer |
148 | complaints; amending s. 408.802, F.S.; removing |
149 | applicability of part II of ch. 408, F.S., relating to |
150 | general licensure requirements, to private review agents; |
151 | amending s. 408.804, F.S.; providing penalties for |
152 | altering, defacing, or falsifying a license certificate |
153 | issued by the agency or displaying such an altered, |
154 | defaced, or falsified certificate; amending s. 408.806, |
155 | F.S.; revising agency responsibilities for notification of |
156 | licensees of impending expiration of a license; requiring |
157 | payment of a late fee for a license application to be |
158 | considered complete under certain circumstances; amending |
159 | s. 408.810, F.S.; revising provisions relating to |
160 | information required for licensure; requiring proof of |
161 | submission of notice to a mortgagor or landlord regarding |
162 | provision of services requiring licensure; requiring |
163 | disclosure of information by a controlling interest of |
164 | certain court actions relating to financial instability |
165 | within a specified time period; amending s. 408.813, F.S.; |
166 | authorizing the agency to impose fines for unclassified |
167 | violations of part II of ch. 408, F.S.; amending s. |
168 | 408.815, F.S.; authorizing the agency to extend a license |
169 | expiration date under certain circumstances; amending s. |
170 | 409.221, F.S.; deleting a reporting requirement relating |
171 | to the consumer-directed care program; amending s. |
172 | 409.91196, F.S.; conforming a cross-reference; amending s. |
173 | 409.912, F.S.; revising procedures for implementation of a |
174 | Medicaid prescribed-drug spending-control program; |
175 | amending s. 429.07, F.S.; deleting the requirement for an |
176 | assisted living facility to obtain an additional license |
177 | in order to provide limited nursing services; deleting the |
178 | requirement for the agency to conduct quarterly monitoring |
179 | visits of facilities that hold a license to provide |
180 | extended congregate care services; deleting the |
181 | requirement for the department to report annually on the |
182 | status of and recommendations related to extended |
183 | congregate care; deleting the requirement for the agency |
184 | to conduct monitoring visits at least twice a year to |
185 | facilities providing limited nursing services; increasing |
186 | the licensure fees and the maximum fee required for the |
187 | standard license; increasing the licensure fees for the |
188 | extended congregate care license; eliminating the license |
189 | fee for the limited nursing services license; transferring |
190 | from another provision of law the requirement that a |
191 | biennial survey of an assisted living facility include |
192 | specific actions to determine whether the facility is |
193 | adequately protecting residents' rights; providing that an |
194 | assisted living facility that has a class I or class II |
195 | violation is subject to monitoring visits; requiring a |
196 | registered nurse to participate in certain monitoring |
197 | visits; amending s. 429.11, F.S.; revising licensure |
198 | application requirements for assisted living facilities to |
199 | eliminate provisional licenses; amending s. 429.12, F.S.; |
200 | revising notification requirements for the sale or |
201 | transfer of ownership of an assisted living facility; |
202 | amending s. 429.14, F.S.; removing a ground for the |
203 | imposition of an administrative penalty; clarifying |
204 | provisions relating to a facility's request for a hearing |
205 | under certain circumstances; authorizing the agency to |
206 | provide certain information relating to the licensure |
207 | status of assisted living facilities electronically or |
208 | through the agency's Internet website; amending s. 429.17, |
209 | F.S.; deleting provisions relating to the limited nursing |
210 | services license; revising agency responsibilities |
211 | regarding the issuance of conditional licenses; amending |
212 | s. 429.19, F.S.; clarifying that a monitoring fee may be |
213 | assessed in addition to an administrative fine; amending |
214 | s. 429.23, F.S.; deleting reporting requirements for |
215 | assisted living facilities relating to liability claims; |
216 | amending s. 429.255, F.S.; eliminating provisions |
217 | authorizing the use of volunteers to provide certain |
218 | health-care-related services in assisted living |
219 | facilities; authorizing assisted living facilities to |
220 | provide limited nursing services; requiring an assisted |
221 | living facility to be responsible for certain |
222 | recordkeeping and staff to be trained to monitor residents |
223 | receiving certain health-care-related services; amending |
224 | s. 429.28, F.S.; deleting a requirement for a biennial |
225 | survey of an assisted living facility, to conform to |
226 | changes made by the act; amending s. 429.35, F.S.; |
227 | authorizing the agency to provide certain information |
228 | relating to the inspections of assisted living facilities |
229 | electronically or through the agency's Internet website; |
230 | amending s. 429.41, F.S., relating to rulemaking; |
231 | conforming provisions to changes made by the act; amending |
232 | s. 429.53, F.S.; revising provisions relating to |
233 | consultation by the agency; revising a definition; |
234 | amending s. 429.54, F.S.; requiring licensed assisted |
235 | living facilities to electronically report certain data |
236 | semiannually to the agency in accordance with rules |
237 | adopted by the department; amending s. 429.71, F.S.; |
238 | revising schedule of inspection violations for adult |
239 | family-care homes; amending s. 429.911, F.S.; deleting a |
240 | ground for agency action against an adult day care center; |
241 | amending s. 429.915, F.S.; revising agency |
242 | responsibilities regarding the issuance of conditional |
243 | licenses; amending s. 483.294, F.S.; revising frequency of |
244 | agency inspections of multiphasic health testing centers; |
245 | amending s. 499.003, F.S.; defining the term "medical |
246 | convenience kit" for purposes of pt. I of ch. 499, F.S.; |
247 | providing an exception to applicability of the term; |
248 | removing a requirement that certain prescription drug |
249 | purchasers maintain a separate inventory of certain |
250 | prescription drugs; amending s. 499.01212, F.S.; providing |
251 | an exception to the requirement that a wholesale |
252 | distributor of prescription drugs provide a pedigree paper |
253 | to the person who receives the drug for wholesale |
254 | distribution of prescription drugs contained within a |
255 | medical convenience kit under specified conditions; |
256 | providing that the exception does not apply to any kit |
257 | that contains certain controlled substances; amending s. |
258 | 626.9541, F.S.; authorizing an insurer offering a group or |
259 | individual health benefit plan to offer a wellness |
260 | program; authorizing rewards or incentives; providing that |
261 | such rewards or incentives are not insurance benefits; |
262 | providing for verification of a member's inability to |
263 | participate for medical reasons; amending s. 633.081, |
264 | F.S.; limiting Fire Marshal inspections of nursing homes |
265 | to once a year; providing for additional inspections based |
266 | on complaints and violations identified in the course of |
267 | orientation or training activities; amending s. 766.202, |
268 | F.S.; adding persons licensed under part XIV of ch. 468, |
269 | F.S., to the definition of "health care provider"; |
270 | amending ss. 394.4787, 400.0239, 408.07, 430.80, and |
271 | 651.118, F.S.; conforming terminology and cross- |
272 | references; revising a reference; providing an effective |
273 | date. |
274 |
|
275 | Be It Enacted by the Legislature of the State of Florida: |
276 |
|
277 | Section 1. Present paragraph (e) of subsection (10) and |
278 | paragraph (e) of subsection (14) of section 112.0455, Florida |
279 | Statutes, are amended, and paragraphs (f) through (k) of |
280 | subsection (10) of that section are redesignated as paragraphs |
281 | (e) through (j), respectively, to read: |
282 | 112.0455 Drug-Free Workplace Act.- |
283 | (10) EMPLOYER PROTECTION.- |
284 | (e) Nothing in this section shall be construed to operate |
285 | retroactively, and nothing in this section shall abrogate the |
286 | right of an employer under state law to conduct drug tests prior |
287 | to January 1, 1990. A drug test conducted by an employer prior |
288 | to January 1, 1990, is not subject to this section. |
289 | (14) DISCIPLINE REMEDIES.- |
290 | (e) Upon resolving an appeal filed pursuant to paragraph |
291 | (c), and finding a violation of this section, the commission may |
292 | order the following relief: |
293 | 1. Rescind the disciplinary action, expunge related |
294 | records from the personnel file of the employee or job applicant |
295 | and reinstate the employee. |
296 | 2. Order compliance with paragraph (10)(f)(g). |
297 | 3. Award back pay and benefits. |
298 | 4. Award the prevailing employee or job applicant the |
299 | necessary costs of the appeal, reasonable attorney's fees, and |
300 | expert witness fees. |
301 | Section 2. Paragraph (n) of subsection (1) of section |
302 | 154.11, Florida Statutes, is amended to read: |
303 | 154.11 Powers of board of trustees.- |
304 | (1) The board of trustees of each public health trust |
305 | shall be deemed to exercise a public and essential governmental |
306 | function of both the state and the county and in furtherance |
307 | thereof it shall, subject to limitation by the governing body of |
308 | the county in which such board is located, have all of the |
309 | powers necessary or convenient to carry out the operation and |
310 | governance of designated health care facilities, including, but |
311 | without limiting the generality of, the foregoing: |
312 | (n) To appoint originally the staff of physicians to |
313 | practice in any designated facility owned or operated by the |
314 | board and to approve the bylaws and rules to be adopted by the |
315 | medical staff of any designated facility owned and operated by |
316 | the board, such governing regulations to be in accordance with |
317 | the standards of The Joint Commission on the Accreditation of |
318 | Hospitals which provide, among other things, for the method of |
319 | appointing additional staff members and for the removal of staff |
320 | members. |
321 | Section 3. Subsection (15) of section 318.21, Florida |
322 | Statutes, is amended to read: |
323 | 318.21 Disposition of civil penalties by county courts.- |
324 | All civil penalties received by a county court pursuant to the |
325 | provisions of this chapter shall be distributed and paid monthly |
326 | as follows: |
327 | (15) Of the additional fine assessed under s. 318.18(3)(e) |
328 | for a violation of s. 316.1893, 50 percent of the moneys |
329 | received from the fines shall be remitted to the Department of |
330 | Revenue and deposited into the Brain and Spinal Cord Injury |
331 | Trust Fund of Department of Health and shall be appropriated to |
332 | the Department of Health Agency for Health Care Administration |
333 | as general revenue to provide an enhanced Medicaid payment to |
334 | nursing homes that serve Medicaid recipients with spinal cord |
335 | injuries that are medically complex and who are technologically |
336 | and respiratory dependent with brain and spinal cord injuries. |
337 | The remaining 50 percent of the moneys received from |
338 | enhanced fine imposed under s. 318.18(3)(e) shall be |
339 | the Department of Revenue and deposited into the |
340 | Health Administrative Trust Fund to provide financial support to |
341 | certified trauma centers in the counties where enhanced penalty |
342 | zones are established to ensure the availability and |
343 | accessibility of trauma services. Funds deposited into the |
344 | Administrative Trust Fund under this subsection shall be |
345 | allocated as follows: |
346 | (a) Fifty percent shall be allocated equally among all |
347 | Level I, Level II, and pediatric trauma centers in recognition |
348 | of readiness costs for maintaining trauma services. |
349 | (b) Fifty percent shall be allocated among Level I, Level |
350 | II, and pediatric trauma centers based on each center's relative |
351 | volume of trauma cases as reported in the Department of Health |
352 | Trauma Registry. |
353 | Section 4. Subsection (3) is added to section 381.00315, |
354 | Florida Statutes, to read: |
355 | 381.00315 Public health advisories; public health |
356 | emergencies.-The State Health Officer is responsible for |
357 | declaring public health emergencies and issuing public health |
358 | advisories. |
359 | (3) To facilitate effective emergency management, when the |
360 | United States Department of Health and Human Services contracts |
361 | for the manufacture and delivery of licensable products in |
362 | response to a public health emergency and the terms of those |
363 | contracts are made available to the states, the department shall |
364 | accept funds provided by counties, municipalities, and other |
365 | entities designated in the state emergency management plan |
366 | required under s. 252.35(2)(a) for the purpose of participation |
367 | in such contracts. The department shall deposit the funds into |
368 | the Grants and Donations Trust Fund and expend the funds on |
369 | behalf of the donor county, municipality, or other entity for |
370 | the purchase the licensable products made available under the |
371 | contract. |
372 | Section 5. Paragraph (e) is added to subsection (2) of |
373 | section 381.0072, Florida Statutes, to read: |
374 | 381.0072 Food service protection.-It shall be the duty of |
375 | the Department of Health to adopt and enforce sanitation rules |
376 | consistent with law to ensure the protection of the public from |
377 | food-borne illness. These rules shall provide the standards and |
378 | requirements for the storage, preparation, serving, or display |
379 | of food in food service establishments as defined in this |
380 | section and which are not permitted or licensed under chapter |
381 | 500 or chapter 509. |
382 | (2) DUTIES.- |
383 | (e) The department shall inspect food service |
384 | establishments in nursing homes licensed under part II of |
385 | chapter 400 twice each year. The department may make additional |
386 | inspections only in response to complaints. The department shall |
387 | coordinate inspections with the Agency for Health Care |
388 | Administration, such that the department's inspection is at |
389 | least 60 days after a recertification visit by the Agency for |
390 | Health Care Administration. |
391 | Section 6. Section 383.325, Florida Statutes, is repealed. |
392 | Section 7. Subsection (7) of section 394.4787, Florida |
393 | Statutes, is amended to read: |
394 | 394.4787 Definitions; ss. 394.4786, 394.4787, 394.4788, |
395 | and 394.4789.-As used in this section and ss. 394.4786, |
396 | 394.4788, and 394.4789: |
397 | (7) "Specialty psychiatric hospital" means a hospital |
398 | licensed by the agency pursuant to s. 395.002(26)(28) and part |
399 | II of chapter 408 as a specialty psychiatric hospital. |
400 | Section 8. Subsection (2) of section 394.741, Florida |
401 | Statutes, is amended to read: |
402 | 394.741 Accreditation requirements for providers of |
403 | behavioral health care services.- |
404 | (2) Notwithstanding any provision of law to the contrary, |
405 | accreditation shall be accepted by the agency and department in |
406 | lieu of the agency's and department's facility licensure onsite |
407 | review requirements and shall be accepted as a substitute for |
408 | the department's administrative and program monitoring |
409 | requirements, except as required by subsections (3) and (4), |
410 | for: |
411 | (a) Any organization from which the department purchases |
412 | behavioral health care services that is accredited by The Joint |
413 | Commission on Accreditation of Healthcare Organizations or the |
414 | Council on Accreditation for Children and Family Services, or |
415 | has those services that are being purchased by the department |
416 | accredited by the Commission on Accreditation of Rehabilitation |
417 | Facilities CARF-the Rehabilitation Accreditation Commission. |
418 | (b) Any mental health facility licensed by the agency or |
419 | any substance abuse component licensed by the department that is |
420 | accredited by The Joint Commission on Accreditation of |
421 | Healthcare Organizations, the Commission on Accreditation of |
422 | Rehabilitation Facilities CARF-the Rehabilitation Accreditation |
423 | Commission, or the Council on Accreditation of Children and |
424 | Family Services. |
425 | (c) Any network of providers from which the department or |
426 | the agency purchases behavioral health care services accredited |
427 | by The Joint Commission on Accreditation of Healthcare |
428 | Organizations, the Commission on Accreditation of Rehabilitation |
429 | Facilities CARF-the Rehabilitation Accreditation Commission, the |
430 | Council on Accreditation of Children and Family Services, or the |
431 | National Committee for Quality Assurance. A provider |
432 | organization, which is part of an accredited network, is |
433 | afforded the same rights under this part. |
434 | Section 9. Present subsections (15) through (32) of |
435 | section 395.002, Florida Statutes, are renumbered as subsections |
436 | (14) through (28), respectively, and present subsections (1), |
437 | (14), (24), (30), and (31), and paragraph (c) of present |
438 | subsection (28) of that section are amended to read: |
439 | 395.002 Definitions.-As used in this chapter: |
440 | (1) "Accrediting organizations" means nationally |
441 | recognized or approved accrediting organizations whose standards |
442 | incorporate comparable licensure requirements as determined by |
443 | the agency the Joint Commission on Accreditation of Healthcare |
444 | Organizations, the American Osteopathic Association, the |
445 | Commission on Accreditation of Rehabilitation Facilities, and |
446 | the Accreditation Association for Ambulatory Health Care, Inc. |
447 | (14) "Initial denial determination" means a determination |
448 | by a private review agent that the health care services |
449 | furnished or proposed to be furnished to a patient are |
450 | inappropriate, not medically necessary, or not reasonable. |
451 | (24) "Private review agent" means any person or entity |
452 | which performs utilization review services for third-party |
453 | payors on a contractual basis for outpatient or inpatient |
454 | services. However, the term shall not include full-time |
455 | employees, personnel, or staff of health insurers, health |
456 | maintenance organizations, or hospitals, or wholly owned |
457 | subsidiaries thereof or affiliates under common ownership, when |
458 | performing utilization review for their respective hospitals, |
459 | health maintenance organizations, or insureds of the same |
460 | insurance group. For this purpose, health insurers, health |
461 | maintenance organizations, and hospitals, or wholly owned |
462 | subsidiaries thereof or affiliates under common ownership, |
463 | include such entities engaged as administrators of self- |
464 | insurance as defined in s. 624.031. |
465 | (26)(28) "Specialty hospital" means any facility which |
466 | meets the provisions of subsection (12), and which regularly |
467 | makes available either: |
468 | (c) Intensive residential treatment programs for children |
469 | and adolescents as defined in subsection (14) (15). |
470 | (30) "Utilization review" means a system for reviewing the |
471 | medical necessity or appropriateness in the allocation of health |
472 | care resources of hospital services given or proposed to be |
473 | given to a patient or group of patients. |
474 | (31) "Utilization review plan" means a description of the |
475 | policies and procedures governing utilization review activities |
476 | performed by a private review agent. |
477 | Section 10. Paragraph (c) of subsection (1) and paragraph |
478 | (b) of subsection (2) of section 395.003, Florida Statutes, are |
479 | amended to read: |
480 | 395.003 Licensure; denial, suspension, and revocation.- |
481 | (1) |
482 | (c) Until July 1, 2006, additional emergency departments |
483 | located off the premises of licensed hospitals may not be |
484 | authorized by the agency. |
485 | (2) |
486 | (b) The agency shall, at the request of a licensee that is |
487 | a teaching hospital as defined in s. 408.07(45), issue a single |
488 | license to a licensee for facilities that have been previously |
489 | licensed as separate premises, provided such separately licensed |
490 | facilities, taken together, constitute the same premises as |
491 | defined in s. 395.002(22)(23). Such license for the single |
492 | premises shall include all of the beds, services, and programs |
493 | that were previously included on the licenses for the separate |
494 | premises. The granting of a single license under this paragraph |
495 | shall not in any manner reduce the number of beds, services, or |
496 | programs operated by the licensee. |
497 | Section 11. Paragraph (e) of subsection (2) and subsection |
498 | (4) of section 395.0193, Florida Statutes, are amended to read: |
499 | 395.0193 Licensed facilities; peer review; disciplinary |
500 | powers; agency or partnership with physicians.- |
501 | (2) Each licensed facility, as a condition of licensure, |
502 | shall provide for peer review of physicians who deliver health |
503 | care services at the facility. Each licensed facility shall |
504 | develop written, binding procedures by which such peer review |
505 | shall be conducted. Such procedures shall include: |
506 | (e) Recording of agendas and minutes which do not contain |
507 | confidential material, for review by the Division of Medical |
508 | Quality Assurance of the department Health Quality Assurance of |
509 | the agency. |
510 | (4) Pursuant to ss. 458.337 and 459.016, any disciplinary |
511 | actions taken under subsection (3) shall be reported in writing |
512 | to the Division of Medical Quality Assurance of the department |
513 | Health Quality Assurance of the agency within 30 working days |
514 | after its initial occurrence, regardless of the pendency of |
515 | appeals to the governing board of the hospital. The notification |
516 | shall identify the disciplined practitioner, the action taken, |
517 | and the reason for such action. All final disciplinary actions |
518 | taken under subsection (3), if different from those which were |
519 | reported to the department agency within 30 days after the |
520 | initial occurrence, shall be reported within 10 working days to |
521 | the Division of Medical Quality Assurance of the department |
522 | Health Quality Assurance of the agency in writing and shall |
523 | specify the disciplinary action taken and the specific grounds |
524 | therefor. The division shall review each report and determine |
525 | whether it potentially involved conduct by the licensee that is |
526 | subject to disciplinary action, in which case s. 456.073 shall |
527 | apply. The reports are not subject to inspection under s. |
528 | 119.07(1) even if the division's investigation results in a |
529 | finding of probable cause. |
530 | Section 12. Section 395.1023, Florida Statutes, is amended |
531 | to read: |
532 | 395.1023 Child abuse and neglect cases; duties.-Each |
533 | licensed facility shall adopt a protocol that, at a minimum, |
534 | requires the facility to: |
535 | (1) Incorporate a facility policy that every staff member |
536 | has an affirmative duty to report, pursuant to chapter 39, any |
537 | actual or suspected case of child abuse, abandonment, or |
538 | neglect; and |
539 | (2) In any case involving suspected child abuse, |
540 | abandonment, or neglect, designate, at the request of the |
541 | Department of Children and Family Services, a staff physician to |
542 | act as a liaison between the hospital and the Department of |
543 | Children and Family Services office which is investigating the |
544 | suspected abuse, abandonment, or neglect, and the child |
545 | protection team, as defined in s. 39.01, when the case is |
546 | referred to such a team. |
547 |
|
548 | Each general hospital and appropriate specialty hospital shall |
549 | comply with the provisions of this section and shall notify the |
550 | agency and the Department of Children and Family Services of its |
551 | compliance by sending a copy of its policy to the agency and the |
552 | Department of Children and Family Services as required by rule. |
553 | The failure by a general hospital or appropriate specialty |
554 | hospital to comply shall be punished by a fine not exceeding |
555 | $1,000, to be fixed, imposed, and collected by the agency. Each |
556 | day in violation is considered a separate offense. |
557 | Section 13. Subsection (2) and paragraph (d) of subsection |
558 | (3) of section 395.1041, Florida Statutes, are amended to read: |
559 | 395.1041 Access to emergency services and care.- |
560 | (2) INVENTORY OF HOSPITAL EMERGENCY SERVICES.-The agency |
561 | shall establish and maintain an inventory of hospitals with |
562 | emergency services. The inventory shall list all services within |
563 | the service capability of the hospital, and such services shall |
564 | appear on the face of the hospital license. Each hospital having |
565 | emergency services shall notify the agency of its service |
566 | capability in the manner and form prescribed by the agency. The |
567 | agency shall use the inventory to assist emergency medical |
568 | services providers and others in locating appropriate emergency |
569 | medical care. The inventory shall also be made available to the |
570 | general public. On or before August 1, 1992, the agency shall |
571 | request that each hospital identify the services which are |
572 | within its service capability. On or before November 1, 1992, |
573 | the agency shall notify each hospital of the service capability |
574 | to be included in the inventory. The hospital has 15 days from |
575 | the date of receipt to respond to the notice. By December 1, |
576 | 1992, the agency shall publish a final inventory. Each hospital |
577 | shall reaffirm its service capability when its license is |
578 | renewed and shall notify the agency of the addition of a new |
579 | service or the termination of a service prior to a change in its |
580 | service capability. |
581 | (3) EMERGENCY SERVICES; DISCRIMINATION; LIABILITY OF |
582 | FACILITY OR HEALTH CARE PERSONNEL.- |
583 | (d)1. Every hospital shall ensure the provision of |
584 | services within the service capability of the hospital, at all |
585 | times, either directly or indirectly through an arrangement with |
586 | another hospital, through an arrangement with one or more |
587 | physicians, or as otherwise made through prior arrangements. A |
588 | hospital may enter into an agreement with another hospital for |
589 | purposes of meeting its service capability requirement, and |
590 | appropriate compensation or other reasonable conditions may be |
591 | negotiated for these backup services. |
592 | 2. If any arrangement requires the provision of emergency |
593 | medical transportation, such arrangement must be made in |
594 | consultation with the applicable provider and may not require |
595 | the emergency medical service provider to provide transportation |
596 | that is outside the routine service area of that provider or in |
597 | a manner that impairs the ability of the emergency medical |
598 | service provider to timely respond to prehospital emergency |
599 | calls. |
600 | 3. A hospital shall not be required to ensure service |
601 | capability at all times as required in subparagraph 1. if, prior |
602 | to the receiving of any patient needing such service capability, |
603 | such hospital has demonstrated to the agency that it lacks the |
604 | ability to ensure such capability and it has exhausted all |
605 | reasonable efforts to ensure such capability through backup |
606 | arrangements. In reviewing a hospital's demonstration of lack of |
607 | ability to ensure service capability, the agency shall consider |
608 | factors relevant to the particular case, including the |
609 | following: |
610 | a. Number and proximity of hospitals with the same service |
611 | capability. |
612 | b. Number, type, credentials, and privileges of |
613 | specialists. |
614 | c. Frequency of procedures. |
615 | d. Size of hospital. |
616 | 4. The agency shall publish proposed rules implementing a |
617 | reasonable exemption procedure by November 1, 1992. Subparagraph |
618 | 1. shall become effective upon the effective date of said rules |
619 | or January 31, 1993, whichever is earlier. For a period not to |
620 | exceed 1 year from the effective date of subparagraph 1., a |
621 | hospital requesting an exemption shall be deemed to be exempt |
622 | from offering the service until the agency initially acts to |
623 | deny or grant the original request. The agency has 45 days from |
624 | the date of receipt of the request to approve or deny the |
625 | request. After the first year from the effective date of |
626 | subparagraph 1., If the agency fails to initially act within the |
627 | time period, the hospital is deemed to be exempt from offering |
628 | the service until the agency initially acts to deny the request. |
629 | Section 14. Section 395.1046, Florida Statutes, is |
630 | repealed. |
631 | Section 15. Paragraph (e) of subsection (1) of section |
632 | 395.1055, Florida Statutes, is amended to read: |
633 | 395.1055 Rules and enforcement.- |
634 | (1) The agency shall adopt rules pursuant to ss. |
635 | 120.536(1) and 120.54 to implement the provisions of this part, |
636 | which shall include reasonable and fair minimum standards for |
637 | ensuring that: |
638 | (e) Licensed facility beds conform to minimum space, |
639 | equipment, and furnishings standards as specified by the agency, |
640 | the Florida Building Code, and the Florida Fire Prevention Code |
641 | department. |
642 | Section 16. Subsection (1) of section 395.10972, Florida |
643 | Statutes, is amended to read: |
644 | 395.10972 Health Care Risk Manager Advisory Council.-The |
645 | Secretary of Health Care Administration may appoint a seven- |
646 | member advisory council to advise the agency on matters |
647 | pertaining to health care risk managers. The members of the |
648 | council shall serve at the pleasure of the secretary. The |
649 | council shall designate a chair. The council shall meet at the |
650 | call of the secretary or at those times as may be required by |
651 | rule of the agency. The members of the advisory council shall |
652 | receive no compensation for their services, but shall be |
653 | reimbursed for travel expenses as provided in s. 112.061. The |
654 | council shall consist of individuals representing the following |
655 | areas: |
656 | (1) Two shall be active health care risk managers, |
657 | including one risk manager who is recommended by and a member of |
658 | the Florida Society for of Healthcare Risk Management and |
659 | Patient Safety. |
660 | Section 17. Subsection (3) of section 395.2050, Florida |
661 | Statutes, is amended to read: |
662 | 395.2050 Routine inquiry for organ and tissue donation; |
663 | certification for procurement activities; death records review.- |
664 | (3) Each organ procurement organization designated by the |
665 | federal Centers for Medicare and Medicaid Services Health Care |
666 | Financing Administration and licensed by the state |
667 | an annual death records review in the organ procurement |
668 | organization's affiliated donor hospitals. The organ procurement |
669 | organization shall enlist the services of every Florida licensed |
670 | tissue bank and eye bank affiliated with or providing service to |
671 | the donor hospital and operating in the same service area to |
672 | participate in the death records review. |
673 | Section 18. Subsection (2) of section 395.3036, Florida |
674 | Statutes, is amended to read: |
675 | 395.3036 Confidentiality of records and meetings of |
676 | corporations that lease public hospitals or other public health |
677 | care facilities.-The records of a private corporation that |
678 | leases a public hospital or other public health care facility |
679 | are confidential and exempt from the provisions of s. 119.07(1) |
680 | and s. 24(a), Art. I of the State Constitution, and the meetings |
681 | of the governing board of a private corporation are exempt from |
682 | s. 286.011 and s. 24(b), Art. I of the State Constitution when |
683 | the public lessor complies with the public finance |
684 | accountability provisions of s. 155.40(5) with respect to the |
685 | transfer of any public funds to the private lessee and when the |
686 | private lessee meets at least three of the five following |
687 | criteria: |
688 | (2) The public lessor and the private lessee do not |
689 | commingle any of their funds in any account maintained by either |
690 | of them, other than the payment of the rent and administrative |
691 | fees or the transfer of funds pursuant to s. 155.40 (2) |
692 | subsection (2). |
693 | Section 19. Section 395.3037, Florida Statutes, is |
694 | repealed. |
695 | Section 20. Subsections (1), (4), and (5) of section |
696 | 395.3038, Florida Statutes, are amended to read: |
697 | 395.3038 State-listed primary stroke centers and |
698 | comprehensive stroke centers; notification of hospitals.- |
699 | (1) The agency shall make available on its website and to |
700 | the department a list of the name and address of each hospital |
701 | that meets the criteria for a primary stroke center and the name |
702 | and address of each hospital that meets the criteria for a |
703 | comprehensive stroke center. The list of primary and |
704 | comprehensive stroke centers shall include only those hospitals |
705 | that attest in an affidavit submitted to the agency that the |
706 | hospital meets the named criteria, or those hospitals that |
707 | attest in an affidavit submitted to the agency that the hospital |
708 | is certified as a primary or a comprehensive stroke center by |
709 | The Joint Commission on Accreditation of Healthcare |
710 | Organizations. |
711 | (4) The agency shall adopt by rule criteria for a primary |
712 | stroke center which are substantially similar to the |
713 | certification standards for primary stroke centers of The Joint |
714 | Commission on Accreditation of Healthcare Organizations. |
715 | (5) The agency shall adopt by rule criteria for a |
716 | comprehensive stroke center. However, if The Joint Commission on |
717 | Accreditation of Healthcare Organizations establishes criteria |
718 | for a comprehensive stroke center, the agency shall establish |
719 | criteria for a comprehensive stroke center which are |
720 | substantially similar to those criteria established by The Joint |
721 | Commission on Accreditation of Healthcare Organizations. |
722 | Section 21. Paragraph (e) of subsection (2) of section |
723 | 395.602, Florida Statutes, is amended to read: |
724 | 395.602 Rural hospitals.- |
725 | (2) DEFINITIONS.-As used in this part: |
726 | (e) "Rural hospital" means an acute care hospital licensed |
727 | under this chapter, having 100 or fewer licensed beds and an |
728 | emergency room, which is: |
729 | 1. The sole provider within a county with a population |
730 | density of no greater than 100 persons per square mile; |
731 | 2. An acute care hospital, in a county with a population |
732 | density of no greater than 100 persons per square mile, which is |
733 | at least 30 minutes of travel time, on normally traveled roads |
734 | under normal traffic conditions, from any other acute care |
735 | hospital within the same county; |
736 | 3. A hospital supported by a tax district or subdistrict |
737 | whose boundaries encompass a population of 100 persons or fewer |
738 | per square mile; |
739 | 4. A hospital in a constitutional charter county with a |
740 | population of over 1 million persons that has imposed a local |
741 | option health service tax pursuant to law and in an area that |
742 | was directly impacted by a catastrophic event on August 24, |
743 | 1992, for which the Governor of Florida declared a state of |
744 | emergency pursuant to chapter 125, and has 120 beds or less that |
745 | serves an agricultural community with an emergency room |
746 | utilization of no less than 20,000 visits and a Medicaid |
747 | inpatient utilization rate greater than 15 percent; |
748 | 4.5. A hospital with a service area that has a population |
749 | of 100 persons or fewer per square mile. As used in this |
750 | subparagraph, the term "service area" means the fewest number of |
751 | zip codes that account for 75 percent of the hospital's |
752 | discharges for the most recent 5-year period, based on |
753 | information available from the hospital inpatient discharge |
754 | database in the Florida Center for Health Information and Policy |
755 | Analysis at the Agency for Health Care Administration; or |
756 | 5.6. A hospital designated as a critical access hospital, |
757 | as defined in s. 408.07(15). |
758 |
|
759 | Population densities used in this paragraph must be based upon |
760 | the most recently completed United States census. A hospital |
761 | that received funds under s. 409.9116 for a quarter beginning no |
762 | later than July 1, 2002, is deemed to have been and shall |
763 | continue to be a rural hospital from that date through June 30, |
764 | 2015, if the hospital continues to have 100 or fewer licensed |
765 | beds and an emergency room, or meets the criteria of |
766 | subparagraph 4. An acute care hospital that has not previously |
767 | been designated as a rural hospital and that meets the criteria |
768 | of this paragraph shall be granted such designation upon |
769 | application, including supporting documentation to the Agency |
770 | for Health Care Administration. |
771 | Section 22. Subsection (8) of section 400.021, Florida |
772 | Statutes, is amended to read: |
773 | 400.021 Definitions.-When used in this part, unless the |
774 | context otherwise requires, the term: |
775 | (8) "Geriatric outpatient clinic" means a site for |
776 | providing outpatient health care to persons 60 years of age or |
777 | older, which is staffed by a registered nurse or a physician |
778 | assistant, or a licensed practical nurse under the direct |
779 | supervision of a registered nurse, advanced registered nurse |
780 | practitioner, or physician. |
781 | Section 23. Paragraph (g) of subsection (2) of section |
782 | 400.0239, Florida Statutes, is amended to read: |
783 | 400.0239 Quality of Long-Term Care Facility Improvement |
784 | Trust Fund.- |
785 | (2) Expenditures from the trust fund shall be allowable |
786 | for direct support of the following: |
787 | (g) Other initiatives authorized by the Centers for |
788 | Medicare and Medicaid Services for the use of federal civil |
789 | monetary penalties, including projects recommended through the |
790 | Medicaid "Up-or-Out" Quality of Care Contract Management Program |
791 | pursuant to s. 400.148. |
792 | Section 24. Subsection (15) of section 400.0255, Florida |
793 | Statutes, is amended to read |
794 | 400.0255 Resident transfer or discharge; requirements and |
795 | procedures; hearings.- |
796 | (15)(a) The department's Office of Appeals Hearings shall |
797 | conduct hearings under this section. The office shall notify the |
798 | facility of a resident's request for a hearing. |
799 | (b) The department shall, by rule, establish procedures to |
800 | be used for fair hearings requested by residents. These |
801 | procedures shall be equivalent to the procedures used for fair |
802 | hearings for other Medicaid cases appearing in s. 409.285 and |
803 | applicable rules, chapter 10-2, part VI, Florida Administrative |
804 | Code. The burden of proof must be clear and convincing evidence. |
805 | A hearing decision must be rendered within 90 days after receipt |
806 | of the request for hearing. |
807 | (c) If the hearing decision is favorable to the resident |
808 | who has been transferred or discharged, the resident must be |
809 | readmitted to the facility's first available bed. |
810 | (d) The decision of the hearing officer shall be final. |
811 | Any aggrieved party may appeal the decision to the district |
812 | court of appeal in the appellate district where the facility is |
813 | located. Review procedures shall be conducted in accordance with |
814 | the Florida Rules of Appellate Procedure. |
815 | Section 25. Subsection (2) of section 400.063, Florida |
816 | Statutes, is amended to read: |
817 | 400.063 Resident protection.- |
818 | (2) The agency is authorized to establish for each |
819 | facility, subject to intervention by the agency, a separate bank |
820 | account for the deposit to the credit of the agency of any |
821 | moneys received from the Health Care Trust Fund or any other |
822 | moneys received for the maintenance and care of residents in the |
823 | facility, and the agency is authorized to disburse moneys from |
824 | such account to pay obligations incurred for the purposes of |
825 | this section. The agency is authorized to requisition moneys |
826 | from the Health Care Trust Fund in advance of an actual need for |
827 | cash on the basis of an estimate by the agency of moneys to be |
828 | spent under the authority of this section. Any bank account |
829 | established under this section need not be approved in advance |
830 | of its creation as required by s. 17.58, but shall be secured by |
831 | depository insurance equal to or greater than the balance of |
832 | such account or by the pledge of collateral security in |
833 | conformance with criteria established in s. 18.11. The agency |
834 | shall notify the Chief Financial Officer of any such account so |
835 | established and shall make a quarterly accounting to the Chief |
836 | Financial Officer for all moneys deposited in such account. |
837 | Section 26. Subsections (1) and (5) of section 400.071, |
838 | Florida Statutes, are amended to read: |
839 | 400.071 Application for license.- |
840 | (1) In addition to the requirements of part II of chapter |
841 | 408, the application for a license shall be under oath and must |
842 | contain the following: |
843 | (a) The location of the facility for which a license is |
844 | sought and an indication, as in the original application, that |
845 | such location conforms to the local zoning ordinances. |
846 | (b) A signed affidavit disclosing any financial or |
847 | ownership interest that a controlling interest as defined in |
848 | part II of chapter 408 has held in the last 5 years in any |
849 | entity licensed by this state or any other state to provide |
850 | health or residential care which has closed voluntarily or |
851 | involuntarily; has filed for bankruptcy; has had a receiver |
852 | appointed; has had a license denied, suspended, or revoked; or |
853 | has had an injunction issued against it which was initiated by a |
854 | regulatory agency. The affidavit must disclose the reason any |
855 | such entity was closed, whether voluntarily or involuntarily. |
856 | (c) The total number of beds and the total number of |
857 | Medicare and Medicaid certified beds. |
858 | (b)(d) Information relating to the applicant and employees |
859 | which the agency requires by rule. The applicant must |
860 | demonstrate that sufficient numbers of qualified staff, by |
861 | training or experience, will be employed to properly care for |
862 | the type and number of residents who will reside in the |
863 | facility. |
864 | (c)(e) Copies of any civil verdict or judgment involving |
865 | the applicant rendered within the 10 years preceding the |
866 | application, relating to medical negligence, violation of |
867 | residents' rights, or wrongful death. As a condition of |
868 | licensure, the licensee agrees to provide to the agency copies |
869 | of any new verdict or judgment involving the applicant, relating |
870 | to such matters, within 30 days after filing with the clerk of |
871 | the court. The information required in this paragraph shall be |
872 | maintained in the facility's licensure file and in an agency |
873 | database which is available as a public record. |
874 | (5) As a condition of licensure, each facility must |
875 | establish and submit with its application a plan for quality |
876 | assurance and for conducting risk management. |
877 | Section 27. Section 400.0712, Florida Statutes, is amended |
878 | to read: |
879 | 400.0712 Application for inactive license.- |
880 | (1) As specified in this section, the agency may issue an |
881 | inactive license to a nursing home facility for all or a portion |
882 | of its beds. Any request by a licensee that a nursing home or |
883 | portion of a nursing home become inactive must be submitted to |
884 | the agency in the approved format. The facility may not initiate |
885 | any suspension of services, notify residents, or initiate |
886 | inactivity before receiving approval from the agency; and a |
887 | licensee that violates this provision may not be issued an |
888 | inactive license. |
889 | (1)(2) In addition to the powers granted under part II of |
890 | chapter 408, the agency may issue an inactive license to a |
891 | nursing home that chooses to use an unoccupied contiguous |
892 | portion of the facility for an alternative use to meet the needs |
893 | of elderly persons through the use of less restrictive, less |
894 | institutional services. |
895 | (a) An inactive license issued under this subsection may |
896 | be granted for a period not to exceed the current licensure |
897 | expiration date but may be renewed by the agency at the time of |
898 | licensure renewal. |
899 | (b) A request to extend the inactive license must be |
900 | submitted to the agency in the approved format and approved by |
901 | the agency in writing. |
902 | (c) Nursing homes that receive an inactive license to |
903 | provide alternative services shall not receive preference for |
904 | participation in the Assisted Living for the Elderly Medicaid |
905 | waiver. |
906 | (2)(3) The agency shall adopt rules pursuant to ss. |
907 | 120.536(1) and 120.54 necessary to implement this section. |
908 | Section 28. Section 400.111, Florida Statutes, is amended |
909 | to read: |
910 | 400.111 Disclosure of controlling interest.-In addition to |
911 | the requirements of part II of chapter 408, when requested by |
912 | the agency, the licensee shall submit a signed affidavit |
913 | disclosing any financial or ownership interest that a |
914 | controlling interest has held within the last 5 years in any |
915 | entity licensed by the state or any other state to provide |
916 | health or residential care which entity has closed voluntarily |
917 | or involuntarily; has filed for bankruptcy; has had a receiver |
918 | appointed; has had a license denied, suspended, or revoked; or |
919 | has had an injunction issued against it which was initiated by a |
920 | regulatory agency. The affidavit must disclose the reason such |
921 | entity was closed, whether voluntarily or involuntarily. |
922 | Section 29. Subsection (2) of section 400.1183, Florida |
923 | Statutes, is amended to read: |
924 | 400.1183 Resident grievance procedures.- |
925 | (2) Each facility shall maintain records of all grievances |
926 | for agency inspection and shall report to the agency at the time |
927 | of relicensure the total number of grievances handled during the |
928 | prior licensure period, a categorization of the cases underlying |
929 | the grievances, and the final disposition of the grievances. |
930 | Section 30. Paragraphs (o) through (w) of subsection (1) |
931 | of section 400.141, Florida Statutes, are redesignated as |
932 | paragraphs (n) through (u), respectively, and present paragraphs |
933 | (f), (g), (j), (n), (o), and (r) of that subsection are amended, |
934 | to read: |
935 | 400.141 Administration and management of nursing home |
936 | facilities.- |
937 | (1) Every licensed facility shall comply with all |
938 | applicable standards and rules of the agency and shall: |
939 | (f) Be allowed and encouraged by the agency to provide |
940 | other needed services under certain conditions. If the facility |
941 | has a standard licensure status, and has had no class I or class |
942 | II deficiencies during the past 2 years or has been awarded a |
943 | Gold Seal under the program established in s. 400.235, it may be |
944 | encouraged by the agency to provide services, including, but not |
945 | limited to, respite and adult day services, which enable |
946 | individuals to move in and out of the facility. A facility is |
947 | not subject to any additional licensure requirements for |
948 | providing these services. |
949 | 1. Respite care may be offered to persons in need of |
950 | short-term or temporary nursing home services. For each person |
951 | admitted under the respite care program, the facility licensee |
952 | must: |
953 | a. Have a written abbreviated plan of care that, at a |
954 | minimum, includes nutritional requirements, medication orders, |
955 | physician orders, nursing assessments, and dietary preferences. |
956 | The nursing or physician assessments may take the place of all |
957 | other assessments required for full-time residents. |
958 | b. Have a contract that, at a minimum, specifies the |
959 | services to be provided to the respite resident, including |
960 | charges for services, activities, equipment, emergency medical |
961 | services, and the administration of medications. If multiple |
962 | respite admissions for a single person are anticipated, the |
963 | original contract is valid for 1 year after the date of |
964 | execution. |
965 | c. Ensure that each resident is released to his or her |
966 | caregiver or an individual designated in writing by the |
967 | caregiver. |
968 | 2. A person admitted under the respite care program is: |
969 | a. Exempt from requirements in rule related to discharge |
970 | planning. |
971 | b. Covered by the resident's rights set forth in s. |
972 | 400.022(1)(a)-(o) and (r)-(t). Funds or property of the resident |
973 | shall not be considered trust funds subject to the requirements |
974 | of s. 400.022(1)(h) until the resident has been in the facility |
975 | for more than 14 consecutive days. |
976 | c. Allowed to use his or her personal medications for the |
977 | respite stay if permitted by facility policy. The facility must |
978 | obtain a physician's orders for the medications. The caregiver |
979 | may provide information regarding the medications as part of the |
980 | nursing assessment, which must agree with the physician's |
981 | orders. Medications shall be released with the resident upon |
982 | discharge in accordance with current orders. |
983 | 3. A person receiving respite care is entitled to a total |
984 | of 60 days in the facility within a contract year or a calendar |
985 | year if the contract is for less than 12 months. However, each |
986 | single stay may not exceed 14 days. If a stay exceeds 14 |
987 | consecutive days, the facility must comply with all assessment |
988 | and care planning requirements applicable to nursing home |
989 | residents. |
990 | 4. A person receiving respite care must reside in a |
991 | licensed nursing home bed. |
992 | 5. A prospective respite resident must provide medical |
993 | information from a physician, a physician assistant, or a nurse |
994 | practitioner and other information from the primary caregiver as |
995 | may be required by the facility prior to or at the time of |
996 | admission to receive respite care. The medical information must |
997 | include a physician's order for respite care and proof of a |
998 | physical examination by a licensed physician, physician |
999 | assistant, or nurse practitioner. The physician's order and |
1000 | physical examination may be used to provide intermittent respite |
1001 | care for up to 12 months after the date the order is written. |
1002 | 6. The facility must assume the duties of the primary |
1003 | caregiver. To ensure continuity of care and services, the |
1004 | resident is entitled to retain his or her personal physician and |
1005 | must have access to medically necessary services such as |
1006 | physical therapy, occupational therapy, or speech therapy, as |
1007 | needed. The facility must arrange for transportation to these |
1008 | services if necessary. Respite care must be provided in |
1009 | accordance with this part and rules adopted by the agency. |
1010 | However, the agency shall, by rule, adopt modified requirements |
1011 | for resident assessment, resident care plans, resident |
1012 | contracts, physician orders, and other provisions, as |
1013 | appropriate, for short-term or temporary nursing home services. |
1014 | 7. The agency shall allow for shared programming and staff |
1015 | in a facility which meets minimum standards and offers services |
1016 | pursuant to this paragraph, but, if the facility is cited for |
1017 | deficiencies in patient care, may require additional staff and |
1018 | programs appropriate to the needs of service recipients. A |
1019 | person who receives respite care may not be counted as a |
1020 | resident of the facility for purposes of the facility's licensed |
1021 | capacity unless that person receives 24-hour respite care. A |
1022 | person receiving either respite care for 24 hours or longer or |
1023 | adult day services must be included when calculating minimum |
1024 | staffing for the facility. Any costs and revenues generated by a |
1025 | nursing home facility from nonresidential programs or services |
1026 | shall be excluded from the calculations of Medicaid per diems |
1027 | for nursing home institutional care reimbursement. |
1028 | (g) If the facility has a standard license or is a Gold |
1029 | Seal facility, exceeds the minimum required hours of licensed |
1030 | nursing and certified nursing assistant direct care per resident |
1031 | per day, and is part of a continuing care facility licensed |
1032 | under chapter 651 or a retirement community that offers other |
1033 | services pursuant to part III of this chapter or part I or part |
1034 | III of chapter 429 on a single campus, be allowed to share |
1035 | programming and staff. At the time of inspection and in the |
1036 | semiannual report required pursuant to paragraph (n) (o), a |
1037 | continuing care facility or retirement community that uses this |
1038 | option must demonstrate through staffing records that minimum |
1039 | staffing requirements for the facility were met. Licensed nurses |
1040 | and certified nursing assistants who work in the nursing home |
1041 | facility may be used to provide services elsewhere on campus if |
1042 | the facility exceeds the minimum number of direct care hours |
1043 | required per resident per day and the total number of residents |
1044 | receiving direct care services from a licensed nurse or a |
1045 | certified nursing assistant does not cause the facility to |
1046 | violate the staffing ratios required under s. 400.23(3)(a). |
1047 | Compliance with the minimum staffing ratios shall be based on |
1048 | total number of residents receiving direct care services, |
1049 | regardless of where they reside on campus. If the facility |
1050 | receives a conditional license, it may not share staff until the |
1051 | conditional license status ends. This paragraph does not |
1052 | restrict the agency's authority under federal or state law to |
1053 | require additional staff if a facility is cited for deficiencies |
1054 | in care which are caused by an insufficient number of certified |
1055 | nursing assistants or licensed nurses. The agency may adopt |
1056 | rules for the documentation necessary to determine compliance |
1057 | with this provision. |
1058 | (j) Keep full records of resident admissions and |
1059 | discharges; medical and general health status, including medical |
1060 | records, personal and social history, and identity and address |
1061 | of next of kin or other persons who may have responsibility for |
1062 | the affairs of the residents; and individual resident care plans |
1063 | including, but not limited to, prescribed services, service |
1064 | frequency and duration, and service goals. The records shall be |
1065 | open to inspection by the agency. The facility must maintain |
1066 | clinical records on each resident in accordance with accepted |
1067 | professional standards and practices that are complete, |
1068 | accurately documented, readily accessible, and systematically |
1069 | organized. |
1070 | (n) Submit to the agency the information specified in s. |
1071 | 400.071(1)(b) for a management company within 30 days after the |
1072 | effective date of the management agreement. |
1073 | (n)(o)1. Submit semiannually to the agency, or more |
1074 | frequently if requested by the agency, information regarding |
1075 | facility staff-to-resident ratios, staff turnover, and staff |
1076 | stability, including information regarding certified nursing |
1077 | assistants, licensed nurses, the director of nursing, and the |
1078 | facility administrator. For purposes of this reporting: |
1079 | a. Staff-to-resident ratios must be reported in the |
1080 | categories specified in s. 400.23(3)(a) and applicable rules. |
1081 | The ratio must be reported as an average for the most recent |
1082 | calendar quarter. |
1083 | b. Staff turnover must be reported for the most recent 12- |
1084 | month period ending on the last workday of the most recent |
1085 | calendar quarter prior to the date the information is submitted. |
1086 | The turnover rate must be computed quarterly, with the annual |
1087 | rate being the cumulative sum of the quarterly rates. The |
1088 | turnover rate is the total number of terminations or separations |
1089 | experienced during the quarter, excluding any employee |
1090 | terminated during a probationary period of 3 months or less, |
1091 | divided by the total number of staff employed at the end of the |
1092 | period for which the rate is computed, and expressed as a |
1093 | percentage. |
1094 | c. The formula for determining staff stability is the |
1095 | total number of employees that have been employed for more than |
1096 | 12 months, divided by the total number of employees employed at |
1097 | the end of the most recent calendar quarter, and expressed as a |
1098 | percentage. |
1099 | d. A nursing facility that has failed to comply with state |
1100 | minimum-staffing requirements for 2 consecutive days is |
1101 | prohibited from accepting new admissions until the facility has |
1102 | achieved the minimum-staffing requirements for a period of 6 |
1103 | consecutive days. For the purposes of this sub-subparagraph, any |
1104 | person who was a resident of the facility and was absent from |
1105 | the facility for the purpose of receiving medical care at a |
1106 | separate location or was on a leave of absence is not considered |
1107 | a new admission. Failure to impose such an admissions moratorium |
1108 | is subject to a $1,000 fine constitutes a class II deficiency. |
1109 | e. A nursing facility which does not have a conditional |
1110 | license may be cited for failure to comply with the standards in |
1111 | s. 400.23(3)(a)1.a. only if it has failed to meet those |
1112 | standards on 2 consecutive days or if it has failed to meet at |
1113 | least 97 percent of those standards on any one day. |
1114 | f. A facility which has a conditional license must be in |
1115 | compliance with the standards in s. 400.23(3)(a) at all times. |
1116 | 2. This paragraph does not limit the agency's ability to |
1117 | impose a deficiency or take other actions if a facility does not |
1118 | have enough staff to meet the residents' needs. |
1119 | (r) Report to the agency any filing for bankruptcy |
1120 | protection by the facility or its parent corporation, |
1121 | divestiture or spin-off of its assets, or corporate |
1122 | reorganization within 30 days after the completion of such |
1123 | activity. |
1124 | Section 31. Subsection (3) of section 400.142, Florida |
1125 | Statutes, is amended to read: |
1126 | 400.142 Emergency medication kits; orders not to |
1127 | resuscitate.- |
1128 | (3) Facility staff may withhold or withdraw |
1129 | cardiopulmonary resuscitation if presented with an order not to |
1130 | resuscitate executed pursuant to s. 401.45. The agency shall |
1131 | adopt rules providing for the implementation of such orders. |
1132 | Facility staff and facilities shall not be subject to criminal |
1133 | prosecution or civil liability, nor be considered to have |
1134 | engaged in negligent or unprofessional conduct, for withholding |
1135 | or withdrawing cardiopulmonary resuscitation pursuant to such an |
1136 | order and rules adopted by the agency. The absence of an order |
1137 | not to resuscitate executed pursuant to s. 401.45 does not |
1138 | preclude a physician from withholding or withdrawing |
1139 | cardiopulmonary resuscitation as otherwise permitted by law. |
1140 | Section 32. Subsections (11) through (15) of section |
1141 | 400.147, Florida Statutes, are renumbered as subsections (10) |
1142 | through (14), respectively, and present subsection (10) is |
1143 | amended to read: |
1144 | 400.147 Internal risk management and quality assurance |
1145 | program.- |
1146 | (10) By the 10th of each month, each facility subject to |
1147 | this section shall report any notice received pursuant to s. |
1148 | 400.0233(2) and each initial complaint that was filed with the |
1149 | clerk of the court and served on the facility during the |
1150 | previous month by a resident or a resident's family member, |
1151 | guardian, conservator, or personal legal representative. The |
1152 | report must include the name of the resident, the resident's |
1153 | date of birth and social security number, the Medicaid |
1154 | identification number for Medicaid-eligible persons, the date or |
1155 | dates of the incident leading to the claim or dates of |
1156 | residency, if applicable, and the type of injury or violation of |
1157 | rights alleged to have occurred. Each facility shall also submit |
1158 | a copy of the notices received pursuant to s. 400.0233(2) and |
1159 | complaints filed with the clerk of the court. This report is |
1160 | confidential as provided by law and is not discoverable or |
1161 | admissible in any civil or administrative action, except in such |
1162 | actions brought by the agency to enforce the provisions of this |
1163 | part. |
1164 | Section 33. Section 400.148, Florida Statutes, is |
1165 | repealed. |
1166 | Section 34. Paragraph (f) of subsection (5) of section |
1167 | 400.162, Florida Statutes, is amended to read: |
1168 | 400.162 Property and personal affairs of residents.- |
1169 | (5) |
1170 | (f) At least every 3 months, the licensee shall furnish |
1171 | the resident and the guardian, trustee, or conservator, if any, |
1172 | for the resident a complete and verified statement of all funds |
1173 | and other property to which this subsection applies, detailing |
1174 | the amounts and items received, together with their sources and |
1175 | disposition. For resident property, the licensee shall furnish |
1176 | such a statement annually and within 7 calendar days after a |
1177 | request for a statement. In any event, the licensee shall |
1178 | furnish such statements a statement annually and upon the |
1179 | discharge or transfer of a resident. Any governmental agency or |
1180 | private charitable agency contributing funds or other property |
1181 | on account of a resident also shall be entitled to receive such |
1182 | statements statement annually and upon discharge or transfer and |
1183 | such other report as it may require pursuant to law. |
1184 | Section 35. Paragraphs (d) and (e) of subsection (2) of |
1185 | section 400.179, Florida Statutes, are amended to read: |
1186 | 400.179 Liability for Medicaid underpayments and |
1187 | overpayments.- |
1188 | (2) Because any transfer of a nursing facility may expose |
1189 | the fact that Medicaid may have underpaid or overpaid the |
1190 | transferor, and because in most instances, any such underpayment |
1191 | or overpayment can only be determined following a formal field |
1192 | audit, the liabilities for any such underpayments or |
1193 | overpayments shall be as follows: |
1194 | (d) Where the transfer involves a facility that has been |
1195 | leased by the transferor: |
1196 | 1. The transferee shall, as a condition to being issued a |
1197 | license by the agency, acquire, maintain, and provide proof to |
1198 | the agency of a bond with a term of 30 months, renewable |
1199 | annually, in an amount not less than the total of 3 months' |
1200 | Medicaid payments to the facility computed on the basis of the |
1201 | preceding 12-month average Medicaid payments to the facility. |
1202 | 2. A leasehold licensee may meet the requirements of |
1203 | subparagraph 1. by payment of a nonrefundable fee, paid at |
1204 | initial licensure, paid at the time of any subsequent change of |
1205 | ownership, and paid annually thereafter, in the amount of 1 |
1206 | percent of the total of 3 months' Medicaid payments to the |
1207 | facility computed on the basis of the preceding 12-month average |
1208 | Medicaid payments to the facility. If a preceding 12-month |
1209 | average is not available, projected Medicaid payments may be |
1210 | used. The fee shall be deposited into the Grants and Donations |
1211 | Trust Fund and shall be accounted for separately as a Medicaid |
1212 | nursing home overpayment account. These fees shall be used at |
1213 | the sole discretion of the agency to repay nursing home Medicaid |
1214 | overpayments. Payment of this fee shall not release the licensee |
1215 | from any liability for any Medicaid overpayments, nor shall |
1216 | payment bar the agency from seeking to recoup overpayments from |
1217 | the licensee and any other liable party. As a condition of |
1218 | exercising this lease bond alternative, licensees paying this |
1219 | fee must maintain an existing lease bond through the end of the |
1220 | 30-month term period of that bond. The agency is herein granted |
1221 | specific authority to promulgate all rules pertaining to the |
1222 | administration and management of this account, including |
1223 | withdrawals from the account, subject to federal review and |
1224 | approval. This provision shall take effect upon becoming law and |
1225 | shall apply to any leasehold license application. The financial |
1226 | viability of the Medicaid nursing home overpayment account shall |
1227 | be determined by the agency through annual review of the account |
1228 | balance and the amount of total outstanding, unpaid Medicaid |
1229 | overpayments owing from leasehold licensees to the agency as |
1230 | determined by final agency audits. By March 31 of each year, the |
1231 | agency shall assess the cumulative fees collected under this |
1232 | subparagraph, minus any amounts used to repay nursing home |
1233 | Medicaid overpayments and amounts transferred to contribute to |
1234 | the General Revenue Fund pursuant to s. 215.20. If the net |
1235 | cumulative collections, minus amounts utilized to repay nursing |
1236 | home Medicaid overpayments, exceed $25 million, the provisions |
1237 | of this paragraph shall not apply for the subsequent fiscal |
1238 | year. |
1239 | 3. The leasehold licensee may meet the bond requirement |
1240 | through other arrangements acceptable to the agency. The agency |
1241 | is herein granted specific authority to promulgate rules |
1242 | pertaining to lease bond arrangements. |
1243 | 4. All existing nursing facility licensees, operating the |
1244 | facility as a leasehold, shall acquire, maintain, and provide |
1245 | proof to the agency of the 30-month bond required in |
1246 | subparagraph 1., above, on and after July 1, 1993, for each |
1247 | license renewal. |
1248 | 5. It shall be the responsibility of all nursing facility |
1249 | operators, operating the facility as a leasehold, to renew the |
1250 | 30-month bond and to provide proof of such renewal to the agency |
1251 | annually. |
1252 | 6. Any failure of the nursing facility operator to |
1253 | acquire, maintain, renew annually, or provide proof to the |
1254 | agency shall be grounds for the agency to deny, revoke, and |
1255 | suspend the facility license to operate such facility and to |
1256 | take any further action, including, but not limited to, |
1257 | enjoining the facility, asserting a moratorium pursuant to part |
1258 | II of chapter 408, or applying for a receiver, deemed necessary |
1259 | to ensure compliance with this section and to safeguard and |
1260 | protect the health, safety, and welfare of the facility's |
1261 | residents. A lease agreement required as a condition of bond |
1262 | financing or refinancing under s. 154.213 by a health facilities |
1263 | authority or required under s. 159.30 by a county or |
1264 | municipality is not a leasehold for purposes of this paragraph |
1265 | and is not subject to the bond requirement of this paragraph. |
1266 | (e) For the 2009-2010 fiscal year only, the provisions of |
1267 | paragraph (d) shall not apply. This paragraph expires July 1, |
1268 | 2010. |
1269 | Section 36. Subsection (3) of section 400.19, Florida |
1270 | Statutes, is amended to read: |
1271 | 400.19 Right of entry and inspection.- |
1272 | (3) The agency shall every 15 months conduct at least one |
1273 | unannounced inspection to determine compliance by the licensee |
1274 | with statutes, and with rules promulgated under the provisions |
1275 | of those statutes, governing minimum standards of construction, |
1276 | quality and adequacy of care, and rights of residents. The |
1277 | survey shall be conducted every 6 months for the next 2-year |
1278 | period if the facility has been cited for a class I deficiency, |
1279 | has been cited for two or more class II deficiencies arising |
1280 | from separate surveys or investigations within a 60-day period, |
1281 | or has had three or more substantiated complaints within a 6- |
1282 | month period, each resulting in at least one class I or class II |
1283 | deficiency. In addition to any other fees or fines in this part, |
1284 | the agency shall assess a fine for each facility that is subject |
1285 | to the 6-month survey cycle. The fine for the 2-year period |
1286 | shall be $6,000, one-half to be paid at the completion of each |
1287 | survey. The agency may adjust this fine by the change in the |
1288 | Consumer Price Index, based on the 12 months immediately |
1289 | preceding the increase, to cover the cost of the additional |
1290 | surveys. The agency shall verify through subsequent inspection |
1291 | that any deficiency identified during inspection is corrected. |
1292 | However, the agency may verify the correction of a class III or |
1293 | class IV deficiency unrelated to resident rights or resident |
1294 | care without reinspecting the facility if adequate written |
1295 | documentation has been received from the facility, which |
1296 | provides assurance that the deficiency has been corrected. The |
1297 | giving or causing to be given of advance notice of such |
1298 | unannounced inspections by an employee of the agency to any |
1299 | unauthorized person shall constitute cause for suspension of not |
1300 | fewer than 5 working days according to the provisions of chapter |
1301 | 110. |
1302 | Section 37. Section 400.195, Florida Statutes, is |
1303 | repealed. |
1304 | Section 38. Subsection (5) of section 400.23, Florida |
1305 | Statutes, is amended to read: |
1306 | 400.23 Rules; evaluation and deficiencies; licensure |
1307 | status.- |
1308 | (5)(a) The agency, in collaboration with the Division of |
1309 | Children's Medical Services Network of the Department of Health, |
1310 | must, no later than December 31, 1993, adopt rules for minimum |
1311 | standards of care for persons under 21 years of age who reside |
1312 | in nursing home facilities. The rules must include a methodology |
1313 | for reviewing a nursing home facility under ss. 408.031-408.045 |
1314 | which serves only persons under 21 years of age. A facility may |
1315 | be exempt from these standards for specific persons between 18 |
1316 | and 21 years of age, if the person's physician agrees that |
1317 | minimum standards of care based on age are not necessary. |
1318 | (b) The agency, in collaboration with the Division of |
1319 | Children's Medical Services Network, shall adopt rules for |
1320 | minimum staffing requirements for nursing home facilities that |
1321 | serve persons under 21 years of age, which shall apply in lieu |
1322 | of the standards contained in subsection (3). |
1323 | 1. For persons under 21 years of age who require skilled |
1324 | care, the requirements shall include a minimum combined average |
1325 | of licensed nurses, respiratory therapists, respiratory care |
1326 | practitioners, and certified nursing assistants of 3.9 hours of |
1327 | direct care per resident per day for each nursing home facility. |
1328 | 2. For persons under 21 years of age who are fragile, the |
1329 | requirements shall include a minimum combined average of |
1330 | licensed nurses, respiratory therapists, respiratory care |
1331 | practitioners, and certified nursing assistants of 5 hours of |
1332 | direct care per resident per day for each nursing home facility. |
1333 | Section 39. Subsection (1) of section 400.275, Florida |
1334 | Statutes, is amended to read: |
1335 | 400.275 Agency duties.- |
1336 | (1) The agency shall ensure that each newly hired nursing |
1337 | home surveyor, as a part of basic training, is assigned full- |
1338 | time to a licensed nursing home for at least 2 days within a 7- |
1339 | day period to observe facility operations outside of the survey |
1340 | process before the surveyor begins survey responsibilities. Such |
1341 | observations may not be the sole basis of a deficiency citation |
1342 | against the facility. The agency may not assign an individual to |
1343 | be a member of a survey team for purposes of a survey, |
1344 | evaluation, or consultation visit at a nursing home facility in |
1345 | which the surveyor was an employee within the preceding 2 5 |
1346 | years. |
1347 | Section 40. Subsection (2) of section 400.484, Florida |
1348 | Statutes, is amended to read: |
1349 | 400.484 Right of inspection; violations deficiencies; |
1350 | fines.- |
1351 | (2) The agency shall impose fines for various classes of |
1352 | violations deficiencies in accordance with the following |
1353 | schedule: |
1354 | (a) Class I violations are defined in s. 408.813. A class |
1355 | I deficiency is any act, omission, or practice that results in a |
1356 | patient's death, disablement, or permanent injury, or places a |
1357 | patient at imminent risk of death, disablement, or permanent |
1358 | injury. Upon finding a class I violation deficiency, the agency |
1359 | shall impose an administrative fine in |
1360 | each occurrence and each day that the |
1361 | exists. |
1362 | (b) Class II violations are defined in s. 408.813. A class |
1363 | II deficiency is any act, omission, or practice that has a |
1364 | direct adverse effect on the health, safety, or security of a |
1365 | patient. Upon finding a class II violation deficiency, the |
1366 | agency shall impose an administrative fine in the amount of |
1367 | $5,000 for each occurrence and each day that the violation |
1368 | deficiency exists. |
1369 | (c) Class III violations are defined in s. 408.813. A |
1370 | class III deficiency is any act, omission, or practice that has |
1371 | an indirect, adverse effect on the health, safety, or security |
1372 | of a patient. Upon finding an uncorrected or repeated class III |
1373 | violation deficiency, the agency shall impose an administrative |
1374 | fine not to exceed $1,000 for each occurrence and each day that |
1375 | the uncorrected or repeated violation deficiency exists. |
1376 | (d) Class IV violations are defined in s. 408.813. A class |
1377 | IV deficiency is any act, omission, or practice related to |
1378 | required reports, forms, or documents which does not have the |
1379 | potential of negatively affecting patients. These violations are |
1380 | of a type that the agency determines do not threaten the health, |
1381 | safety, or security of patients. Upon finding an uncorrected or |
1382 | repeated class IV violation deficiency, the agency shall impose |
1383 | an administrative fine not to exceed $500 for each occurrence |
1384 | and each day that the uncorrected or repeated violation |
1385 | deficiency exists. |
1386 | Section 41. Paragraph (i) of subsection (1) and subsection |
1387 | (4) of section 400.606, Florida Statutes, are amended to read: |
1388 | 400.606 License; application; renewal; conditional license |
1389 | or permit; certificate of need.- |
1390 | (1) In addition to the requirements of part II of chapter |
1391 | 408, the initial application and change of ownership application |
1392 | must be accompanied by a plan for the delivery of home, |
1393 | residential, and homelike inpatient hospice services to |
1394 | terminally ill persons and their families. Such plan must |
1395 | contain, but need not be limited to: |
1396 | (i) The projected annual operating cost of the hospice. |
1397 |
|
1398 | If the applicant is an existing licensed health care provider, |
1399 | the application must be accompanied by a copy of the most recent |
1400 | profit-loss statement and, if applicable, the most recent |
1401 | licensure inspection report. |
1402 | (4) A freestanding hospice facility that is primarily |
1403 | engaged in providing inpatient and related services and that is |
1404 | not otherwise licensed as a health care facility shall be |
1405 | required to obtain a certificate of need. However, a |
1406 | freestanding hospice facility with six or fewer beds shall not |
1407 | be required to comply with institutional standards such as, but |
1408 | not limited to, standards requiring sprinkler systems, emergency |
1409 | electrical systems, or special lavatory devices. |
1410 | Section 42. Subsection (2) of section 400.607, Florida |
1411 | Statutes, is amended to read: |
1412 | 400.607 Denial, suspension, revocation of license; |
1413 | emergency actions; imposition of administrative fine; grounds.- |
1414 | (2) A violation of this part, part II of chapter 408, or |
1415 | applicable rules Any of the following actions by a licensed |
1416 | hospice or any of its employees shall be grounds for |
1417 | administrative action by the agency against a hospice.: |
1418 | (a) A violation of the provisions of this part, part II of |
1419 | chapter 408, or applicable rules. |
1420 | (b) An intentional or negligent act materially affecting |
1421 | the health or safety of a patient. |
1422 | Section 43. Section 400.915, Florida Statutes, is amended |
1423 | to read: |
1424 | 400.915 Construction and renovation; requirements.-The |
1425 | requirements for the construction or renovation of a PPEC center |
1426 | shall comply with: |
1427 | (1) The provisions of chapter 553, which pertain to |
1428 | building construction standards, including plumbing, electrical |
1429 | code, glass, manufactured buildings, accessibility for the |
1430 | physically disabled; |
1431 | (2) The provisions of s. 633.022 and applicable rules |
1432 | pertaining to physical minimum standards for nonresidential |
1433 | child care physical facilities in rule 10M-12.003, Florida |
1434 | Administrative Code, Child Care Standards; and |
1435 | (3) The standards or rules adopted pursuant to this part |
1436 | and part II of chapter 408. |
1437 | Section 44. Subsection (1) of section 400.925, Florida |
1438 | Statutes, is amended to read: |
1439 | 400.925 Definitions.-As used in this part, the term: |
1440 | (1) "Accrediting organizations" means The Joint Commission |
1441 | on Accreditation of Healthcare Organizations or other national |
1442 | accreditation agencies whose standards for accreditation are |
1443 | comparable to those required by this part for licensure. |
1444 | Section 45. Subsections (3) through (6) of section |
1445 | 400.931, Florida Statutes, are renumbered as subsections (2) |
1446 | through (5), respectively, and present subsection (2) of that |
1447 | section is amended to read: |
1448 | 400.931 Application for license; fee; provisional license; |
1449 | temporary permit.- |
1450 | (2) As an alternative to submitting proof of financial |
1451 | ability to operate as required in s. 408.810(8), the applicant |
1452 | may submit a $50,000 surety bond to the agency. |
1453 | Section 46. Subsection (2) of section 400.932, Florida |
1454 | Statutes, is amended to read: |
1455 | 400.932 Administrative penalties.- |
1456 | (2) A violation of this part, part II of chapter 408, or |
1457 | applicable rules Any of the following actions by an employee of |
1458 | a home medical equipment provider shall be are grounds for |
1459 | administrative action or penalties by the agency.: |
1460 | (a) Violation of this part, part II of chapter 408, or |
1461 | applicable rules. |
1462 | (b) An intentional, reckless, or negligent act that |
1463 | materially affects the health or safety of a patient. |
1464 | Section 47. Subsection (3) of section 400.967, Florida |
1465 | Statutes, is amended to read: |
1466 | 400.967 Rules and classification of violations |
1467 | deficiencies.- |
1468 | (3) The agency shall adopt rules to provide that, when the |
1469 | criteria established under this part and part II of chapter 408 |
1470 | are not met, such violations deficiencies shall be classified |
1471 | according to the nature of the violation deficiency. The agency |
1472 | shall indicate the classification on the face of the notice of |
1473 | deficiencies as follows: |
1474 | (a) Class I violations deficiencies are defined in s. |
1475 | 408.813 those which the agency determines present an imminent |
1476 | danger to the residents or guests of the facility or a |
1477 | substantial probability that death or serious physical harm |
1478 | would result therefrom. The condition or practice constituting a |
1479 | class I violation must be abated or eliminated immediately, |
1480 | unless a fixed period of time, as determined by the agency, is |
1481 | required for correction. A class I violation deficiency is |
1482 | subject to a civil penalty in an amount not less than $5,000 and |
1483 | not exceeding $10,000 for each violation deficiency. A fine may |
1484 | be levied notwithstanding the correction of the violation |
1485 | deficiency. |
1486 | (b) Class II violations deficiencies are defined in s. |
1487 | 408.813 those which the agency determines have a direct or |
1488 | immediate relationship to the health, safety, or security of the |
1489 | facility residents, other than class I deficiencies. A class II |
1490 | violation deficiency is subject to a civil penalty in an amount |
1491 | not less than $1,000 and not exceeding $5,000 for each violation |
1492 | deficiency. A citation for a class II violation deficiency shall |
1493 | specify the time within which the violation deficiency must be |
1494 | corrected. If a class II violation deficiency is corrected |
1495 | within the time specified, no civil penalty shall be imposed, |
1496 | unless it is a repeated offense. |
1497 | (c) Class III violations deficiencies are defined in s. |
1498 | 408.813 those which the agency determines to have an indirect or |
1499 | potential relationship to the health, safety, or security of the |
1500 | facility residents, other than class I or class II deficiencies. |
1501 | A class III violation deficiency is subject to a civil penalty |
1502 | of not less than $500 and not exceeding $1,000 for each |
1503 | deficiency. A citation for a class III violation deficiency |
1504 | shall specify the time within which the violation deficiency |
1505 | must be corrected. If a class III violation deficiency is |
1506 | corrected within the time specified, no civil penalty shall be |
1507 | imposed, unless it is a repeated offense. |
1508 | (d) Class IV violations are defined in s. 408.813. Upon |
1509 | finding an uncorrected or repeated class IV violation, the |
1510 | agency shall impose an administrative fine not to exceed $500 |
1511 | for each occurrence and each day that the uncorrected or |
1512 | repeated violation exists. |
1513 | Section 48. Subsections (4) and (7) of section 400.9905, |
1514 | Florida Statutes, are amended to read: |
1515 | 400.9905 Definitions.- |
1516 | (4) "Clinic" means an entity at which health care services |
1517 | are provided to individuals and which tenders charges for |
1518 | reimbursement for such services, including a mobile clinic and a |
1519 | portable health service or equipment provider. For purposes of |
1520 | this part, the term does not include and the licensure |
1521 | requirements of this part do not apply to: |
1522 | (a) Entities licensed or registered by the state under |
1523 | chapter 395; or entities licensed or registered by the state and |
1524 | providing only health care services within the scope of services |
1525 | authorized under their respective licenses granted under ss. |
1526 | 383.30-383.335, chapter 390, chapter 394, chapter 397, this |
1527 | chapter except part X, chapter 429, chapter 463, chapter 465, |
1528 | chapter 466, chapter 478, part I of chapter 483, chapter 484, or |
1529 | chapter 651; end-stage renal disease providers authorized under |
1530 | 42 C.F.R. part 405, subpart U; or providers certified under 42 |
1531 | C.F.R. part 485, subpart B or subpart H; or any entity that |
1532 | provides neonatal or pediatric hospital-based health care |
1533 | services or other health care services by licensed practitioners |
1534 | solely within a hospital licensed under chapter 395. |
1535 | (b) Entities that own, directly or indirectly, entities |
1536 | licensed or registered by the state pursuant to chapter 395; or |
1537 | entities that own, directly or indirectly, entities licensed or |
1538 | registered by the state and providing only health care services |
1539 | within the scope of services authorized pursuant to their |
1540 | respective licenses granted under ss. 383.30-383.335, chapter |
1541 | 390, chapter 394, chapter 397, this chapter except part X, |
1542 | chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, |
1543 | part I of chapter 483, chapter 484, chapter 651; end-stage renal |
1544 | disease providers authorized under 42 C.F.R. part 405, subpart |
1545 | U; or providers certified under 42 C.F.R. part 485, subpart B or |
1546 | subpart H; or any entity that provides neonatal or pediatric |
1547 | hospital-based health care services by licensed practitioners |
1548 | solely within a hospital licensed under chapter 395. |
1549 | (c) Entities that are owned, directly or indirectly, by an |
1550 | entity licensed or registered by the state pursuant to chapter |
1551 | 395; or entities that are owned, directly or indirectly, by an |
1552 | entity licensed or registered by the state and providing only |
1553 | health care services within the scope of services authorized |
1554 | pursuant to their respective licenses granted under ss. 383.30- |
1555 | 383.335, chapter 390, chapter 394, chapter 397, this chapter |
1556 | except part X, chapter 429, chapter 463, chapter 465, chapter |
1557 | 466, chapter 478, part I of chapter 483, chapter 484, or chapter |
1558 | 651; end-stage renal disease providers authorized under 42 |
1559 | C.F.R. part 405, subpart U; or providers certified under 42 |
1560 | C.F.R. part 485, subpart B or subpart H; or any entity that |
1561 | provides neonatal or pediatric hospital-based health care |
1562 | services by licensed practitioners solely within a hospital |
1563 | under chapter 395. |
1564 | (d) Entities that are under common ownership, directly or |
1565 | indirectly, with an entity licensed or registered by the state |
1566 | pursuant to chapter 395; or entities that are under common |
1567 | ownership, directly or indirectly, with an entity licensed or |
1568 | registered by the state and providing only health care services |
1569 | within the scope of services authorized pursuant to their |
1570 | respective licenses granted under ss. 383.30-383.335, chapter |
1571 | 390, chapter 394, chapter 397, this chapter except part X, |
1572 | chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, |
1573 | part I of chapter 483, chapter 484, or chapter 651; end-stage |
1574 | renal disease providers authorized under 42 C.F.R. part 405, |
1575 | subpart U; or providers certified under 42 C.F.R. part 485, |
1576 | subpart B or subpart H; or any entity that provides neonatal or |
1577 | pediatric hospital-based health care services by licensed |
1578 | practitioners solely within a hospital licensed under chapter |
1579 | 395. |
1580 | (e) An entity that is exempt from federal taxation under |
1581 | 26 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan |
1582 | under 26 U.S.C. s. 409 that has a board of trustees not less |
1583 | than two-thirds of which are Florida-licensed health care |
1584 | practitioners and provides only physical therapy services under |
1585 | physician orders, any community college or university clinic, |
1586 | and any entity owned or operated by the federal or state |
1587 | government, including agencies, subdivisions, or municipalities |
1588 | thereof. |
1589 | (f) A sole proprietorship, group practice, partnership, or |
1590 | corporation that provides health care services by physicians |
1591 | covered by s. 627.419, that is directly supervised by one or |
1592 | more of such physicians, and that is wholly owned by one or more |
1593 | of those physicians or by a physician and the spouse, parent, |
1594 | child, or sibling of that physician. |
1595 | (g) A sole proprietorship, group practice, partnership, or |
1596 | corporation that provides health care services by licensed |
1597 | health care practitioners under chapter 457, chapter 458, |
1598 | chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, |
1599 | chapter 466, chapter 467, chapter 480, chapter 484, chapter 486, |
1600 | chapter 490, chapter 491, or part I, part III, part X, part |
1601 | XIII, or part XIV of chapter 468, or s. 464.012, which are |
1602 | wholly owned by one or more licensed health care practitioners, |
1603 | or the licensed health care practitioners set forth in this |
1604 | paragraph and the spouse, parent, child, or sibling of a |
1605 | licensed health care practitioner, so long as one of the owners |
1606 | who is a licensed health care practitioner is supervising the |
1607 | business activities and is legally responsible for the entity's |
1608 | compliance with all federal and state laws. However, a health |
1609 | care practitioner may not supervise services beyond the scope of |
1610 | the practitioner's license, except that, for the purposes of |
1611 | this part, a clinic owned by a licensee in s. 456.053(3)(b) that |
1612 | provides only services authorized pursuant to s. 456.053(3)(b) |
1613 | may be supervised by a licensee specified in s. 456.053(3)(b). |
1614 | (h) Clinical facilities affiliated with an accredited |
1615 | medical school at which training is provided for medical |
1616 | students, residents, or fellows. |
1617 | (i) Entities that provide only oncology or radiation |
1618 | therapy services by physicians licensed under chapter 458 or |
1619 | chapter 459 or entities that provide oncology or radiation |
1620 | therapy services by physicians licensed under chapter 458 or |
1621 | chapter 459 which are owned by a corporation whose shares are |
1622 | publicly traded on a recognized stock exchange. |
1623 | (j) Clinical facilities affiliated with a college of |
1624 | chiropractic accredited by the Council on Chiropractic Education |
1625 | at which training is provided for chiropractic students. |
1626 | (k) Entities that provide licensed practitioners to staff |
1627 | emergency departments or to deliver anesthesia services in |
1628 | facilities licensed under chapter 395 and that derive at least |
1629 | 90 percent of their gross annual revenues from the provision of |
1630 | such services. Entities claiming an exemption from licensure |
1631 | under this paragraph must provide documentation demonstrating |
1632 | compliance. |
1633 | (l) Orthotic, or prosthetic, pediatric cardiology, or |
1634 | perinatology clinical facilities that are a publicly traded |
1635 | corporation or that are wholly owned, directly or indirectly, by |
1636 | a publicly traded corporation. As used in this paragraph, a |
1637 | publicly traded corporation is a corporation that issues |
1638 | securities traded on an exchange registered with the United |
1639 | States Securities and Exchange Commission as a national |
1640 | securities exchange. |
1641 | (m) Entities that are owned by a corporation that has $250 |
1642 | million or more in total annual sales of health care services |
1643 | provided by licensed health care practitioners if one or more of |
1644 | the owners of the entity is a health care practitioner who is |
1645 | licensed in this state, is responsible for supervising the |
1646 | business activities of the entity, and is legally responsible |
1647 | for the entity's compliance with state law for purposes of this |
1648 | section. |
1649 | (n) Entities that are owned or controlled, directly or |
1650 | indirectly, by a publicly traded entity with $100 million or |
1651 | more, in the aggregate, in total annual revenues derived from |
1652 | providing health care services by licensed health care |
1653 | practitioners that are employed or contracted by an entity |
1654 | described in this paragraph. |
1655 | (7) "Portable health service or equipment provider" means |
1656 | an entity that contracts with or employs persons to provide |
1657 | portable health care services or equipment to multiple locations |
1658 | performing treatment or diagnostic testing of individuals, that |
1659 | bills third-party payors for those services, and that otherwise |
1660 | meets the definition of a clinic in subsection (4). |
1661 | Section 49. Paragraph (b) of subsection (1) and paragraph |
1662 | (c) of subsection (4) of section 400.991, Florida Statutes, are |
1663 | amended to read: |
1664 | 400.991 License requirements; background screenings; |
1665 | prohibitions.- |
1666 | (1) |
1667 | (b) Each mobile clinic must obtain a separate health care |
1668 | clinic license and must provide to the agency, at least |
1669 | quarterly, its projected street location to enable the agency to |
1670 | locate and inspect such clinic. A portable health service or |
1671 | equipment provider must obtain a health care clinic license for |
1672 | a single administrative office and is not required to submit |
1673 | quarterly projected street locations. |
1674 | (4) In addition to the requirements of part II of chapter |
1675 | 408, the applicant must file with the application satisfactory |
1676 | proof that the clinic is in compliance with this part and |
1677 | applicable rules, including: |
1678 | (c) Proof of financial ability to operate as required |
1679 | under ss. s. 408.810(8) and 408.8065. As an alternative to |
1680 | submitting proof of financial ability to operate as required |
1681 | under s. 408.810(8), the applicant may file a surety bond of at |
1682 | least $500,000 which guarantees that the clinic will act in full |
1683 | conformity with all legal requirements for operating a clinic, |
1684 | payable to the agency. The agency may adopt rules to specify |
1685 | related requirements for such surety bond. |
1686 | Section 50. Paragraph (g) of subsection (1) and paragraph |
1687 | (a) of subsection (7) of section 400.9935, Florida Statutes, are |
1688 | amended to read: |
1689 | 400.9935 Clinic responsibilities.- |
1690 | (1) Each clinic shall appoint a medical director or clinic |
1691 | director who shall agree in writing to accept legal |
1692 | responsibility for the following activities on behalf of the |
1693 | clinic. The medical director or the clinic director shall: |
1694 | (g) Conduct systematic reviews of clinic billings to |
1695 | ensure that the billings are not fraudulent or unlawful. Upon |
1696 | discovery of an unlawful charge, the medical director or clinic |
1697 | director shall take immediate corrective action. If the clinic |
1698 | performs only the technical component of magnetic resonance |
1699 | imaging, static radiographs, computed tomography, or positron |
1700 | emission tomography, and provides the professional |
1701 | interpretation of such services, in a fixed facility that is |
1702 | accredited by The Joint Commission on Accreditation of |
1703 | Healthcare Organizations or the Accreditation Association for |
1704 | Ambulatory Health Care, and the American College of Radiology; |
1705 | and if, in the preceding quarter, the percentage of scans |
1706 | performed by that clinic which was billed to all personal injury |
1707 | protection insurance carriers was less than 15 percent, the |
1708 | chief financial officer of the clinic may, in a written |
1709 | acknowledgment provided to the agency, assume the responsibility |
1710 | for the conduct of the systematic reviews of clinic billings to |
1711 | ensure that the billings are not fraudulent or unlawful. |
1712 | (7)(a) Each clinic engaged in magnetic resonance imaging |
1713 | services must be accredited by The Joint Commission on |
1714 | Accreditation of Healthcare Organizations, the American College |
1715 | of Radiology, or the Accreditation Association for Ambulatory |
1716 | Health Care, within 1 year after licensure. A clinic that is |
1717 | accredited by the American College of Radiology or is within the |
1718 | original 1-year period after licensure and replaces its core |
1719 | magnetic resonance imaging equipment shall be given 1 year after |
1720 | the date on which the equipment is replaced to attain |
1721 | accreditation. However, a clinic may request a single, 6-month |
1722 | extension if it provides evidence to the agency establishing |
1723 | that, for good cause shown, such clinic cannot be accredited |
1724 | within 1 year after licensure, and that such accreditation will |
1725 | be completed within the 6-month extension. After obtaining |
1726 | accreditation as required by this subsection, each such clinic |
1727 | must maintain accreditation as a condition of renewal of its |
1728 | license. A clinic that files a change of ownership application |
1729 | must comply with the original accreditation timeframe |
1730 | requirements of the transferor. The agency shall deny a change |
1731 | of ownership application if the clinic is not in compliance with |
1732 | the accreditation requirements. When a clinic adds, replaces, or |
1733 | modifies magnetic resonance imaging equipment and the |
1734 | accreditation agency requires new accreditation, the clinic must |
1735 | be accredited within 1 year after the date of the addition, |
1736 | replacement, or modification but may request a single, 6-month |
1737 | extension if the clinic provides evidence of good cause to the |
1738 | agency. |
1739 | Section 51. Subsection (2) of section 408.034, Florida |
1740 | Statutes, is amended to read: |
1741 | 408.034 Duties and responsibilities of agency; rules.- |
1742 | (2) In the exercise of its authority to issue licenses to |
1743 | health care facilities and health service providers, as provided |
1744 | under chapters 393 and 395 and parts II, and IV, and VIII of |
1745 | chapter 400, the agency may not issue a license to any health |
1746 | care facility or health service provider that fails to receive a |
1747 | certificate of need or an exemption for the licensed facility or |
1748 | service. |
1749 | Section 52. Paragraph (d) of subsection (1) of section |
1750 | 408.036, Florida Statutes, is amended to read: |
1751 | 408.036 Projects subject to review; exemptions.- |
1752 | (1) APPLICABILITY.-Unless exempt under subsection (3), all |
1753 | health-care-related projects, as described in paragraphs (a)- |
1754 | (g), are subject to review and must file an application for a |
1755 | certificate of need with the agency. The agency is exclusively |
1756 | responsible for determining whether a health-care-related |
1757 | project is subject to review under ss. 408.031-408.045. |
1758 | (d) The establishment of a hospice or hospice inpatient |
1759 | facility, except as provided in s. 408.043. |
1760 | Section 53. Subsection (2) of section 408.043, Florida |
1761 | Statutes, is amended to read: |
1762 | 408.043 Special provisions.- |
1763 | (2) HOSPICES.-When an application is made for a |
1764 | certificate of need to establish or to expand a hospice, the |
1765 | need for such hospice shall be determined on the basis of the |
1766 | need for and availability of hospice services in the community. |
1767 | The formula on which the certificate of need is based shall |
1768 | discourage regional monopolies and promote competition. The |
1769 | inpatient hospice care component of a hospice which is a |
1770 | freestanding facility, or a part of a facility, which is |
1771 | primarily engaged in providing inpatient care and related |
1772 | services and is not licensed as a health care facility shall |
1773 | also be required to obtain a certificate of need. Provision of |
1774 | hospice care by any current provider of health care is a |
1775 | significant change in service and therefore requires a |
1776 | certificate of need for such services. |
1777 | Section 54. Paragraph (k) of subsection (3) of section |
1778 | 408.05, Florida Statutes, is amended to read: |
1779 | 408.05 Florida Center for Health Information and Policy |
1780 | Analysis.- |
1781 | (3) COMPREHENSIVE HEALTH INFORMATION SYSTEM.-In order to |
1782 | produce comparable and uniform health information and statistics |
1783 | for the development of policy recommendations, the agency shall |
1784 | perform the following functions: |
1785 | (k) Develop, in conjunction with the State Consumer Health |
1786 | Information and Policy Advisory Council, and implement a long- |
1787 | range plan for making available health care quality measures and |
1788 | financial data that will allow consumers to compare health care |
1789 | services. The health care quality measures and financial data |
1790 | the agency must make available shall include, but is not limited |
1791 | to, pharmaceuticals, physicians, health care facilities, and |
1792 | health plans and managed care entities. The agency shall submit |
1793 | the initial plan to the Governor, the President of the Senate, |
1794 | and the Speaker of the House of Representatives by January 1, |
1795 | 2006, and shall update the plan and report on the status of its |
1796 | implementation annually thereafter. The agency shall also make |
1797 | the plan and status report available to the public on its |
1798 | Internet website. As part of the plan, the agency shall identify |
1799 | the process and timeframes for implementation, any barriers to |
1800 | implementation, and recommendations of changes in the law that |
1801 | may be enacted by the Legislature to eliminate the barriers. As |
1802 | preliminary elements of the plan, the agency shall: |
1803 | 1. Make available patient-safety indicators, inpatient |
1804 | quality indicators, and performance outcome and patient charge |
1805 | data collected from health care facilities pursuant to s. |
1806 | 408.061(1)(a) and (2). The terms "patient-safety indicators" and |
1807 | "inpatient quality indicators" shall be as defined by the |
1808 | Centers for Medicare and Medicaid Services, the National Quality |
1809 | Forum, The Joint Commission on Accreditation of Healthcare |
1810 | Organizations, the Agency for Healthcare Research and Quality, |
1811 | the Centers for Disease Control and Prevention, or a similar |
1812 | national entity that establishes standards to measure the |
1813 | performance of health care providers, or by other states. The |
1814 | agency shall determine which conditions, procedures, health care |
1815 | quality measures, and patient charge data to disclose based upon |
1816 | input from the council. When determining which conditions and |
1817 | procedures are to be disclosed, the council and the agency shall |
1818 | consider variation in costs, variation in outcomes, and |
1819 | magnitude of variations and other relevant information. When |
1820 | determining which health care quality measures to disclose, the |
1821 | agency: |
1822 | a. Shall consider such factors as volume of cases; average |
1823 | patient charges; average length of stay; complication rates; |
1824 | mortality rates; and infection rates, among others, which shall |
1825 | be adjusted for case mix and severity, if applicable. |
1826 | b. May consider such additional measures that are adopted |
1827 | by the Centers for Medicare and Medicaid Studies, National |
1828 | Quality Forum, The Joint Commission on Accreditation of |
1829 | Healthcare Organizations, the Agency for Healthcare Research and |
1830 | Quality, Centers for Disease Control and Prevention, or a |
1831 | similar national entity that establishes standards to measure |
1832 | the performance of health care providers, or by other states. |
1833 |
|
1834 | When determining which patient charge data to disclose, the |
1835 | agency shall include such measures as the average of |
1836 | undiscounted charges on frequently performed procedures and |
1837 | preventive diagnostic procedures, the range of procedure charges |
1838 | from highest to lowest, average net revenue per adjusted patient |
1839 | day, average cost per adjusted patient day, and average cost per |
1840 | admission, among others. |
1841 | 2. Make available performance measures, benefit design, |
1842 | and premium cost data from health plans licensed pursuant to |
1843 | chapter 627 or chapter 641. The agency shall determine which |
1844 | health care quality measures and member and subscriber cost data |
1845 | to disclose, based upon input from the council. When determining |
1846 | which data to disclose, the agency shall consider information |
1847 | that may be required by either individual or group purchasers to |
1848 | assess the value of the product, which may include membership |
1849 | satisfaction, quality of care, current enrollment or membership, |
1850 | coverage areas, accreditation status, premium costs, plan costs, |
1851 | premium increases, range of benefits, copayments and |
1852 | deductibles, accuracy and speed of claims payment, credentials |
1853 | of physicians, number of providers, names of network providers, |
1854 | and hospitals in the network. Health plans shall make available |
1855 | to the agency any such data or information that is not currently |
1856 | reported to the agency or the office. |
1857 | 3. Determine the method and format for public disclosure |
1858 | of data reported pursuant to this paragraph. The agency shall |
1859 | make its determination based upon input from the State Consumer |
1860 | Health Information and Policy Advisory Council. At a minimum, |
1861 | the data shall be made available on the agency's Internet |
1862 | website in a manner that allows consumers to conduct an |
1863 | interactive search that allows them to view and compare the |
1864 | information for specific providers. The website must include |
1865 | such additional information as is determined necessary to ensure |
1866 | that the website enhances informed decisionmaking among |
1867 | consumers and health care purchasers, which shall include, at a |
1868 | minimum, appropriate guidance on how to use the data and an |
1869 | explanation of why the data may vary from provider to provider. |
1870 | The data specified in subparagraph 1. shall be released no later |
1871 | than January 1, 2006, for the reporting of infection rates, and |
1872 | no later than October 1, 2005, for mortality rates and |
1873 | complication rates. The data specified in subparagraph 2. shall |
1874 | be released no later than October 1, 2006. |
1875 | 4. Publish on its website undiscounted charges for no |
1876 | fewer than 150 of the most commonly performed adult and |
1877 | pediatric procedures, including outpatient, inpatient, |
1878 | diagnostic, and preventative procedures. |
1879 | Section 55. Paragraph (a) of subsection (1) of section |
1880 | 408.061, Florida Statutes, is amended to read: |
1881 | 408.061 Data collection; uniform systems of financial |
1882 | reporting; information relating to physician charges; |
1883 | confidential information; immunity.- |
1884 | (1) The agency shall require the submission by health care |
1885 | facilities, health care providers, and health insurers of data |
1886 | necessary to carry out the agency's duties. Specifications for |
1887 | data to be collected under this section shall be developed by |
1888 | the agency with the assistance of technical advisory panels |
1889 | including representatives of affected entities, consumers, |
1890 | purchasers, and such other interested parties as may be |
1891 | determined by the agency. |
1892 | (a) Data submitted by health care facilities, including |
1893 | the facilities as defined in chapter 395, shall include, but are |
1894 | not limited to: case-mix data, patient admission and discharge |
1895 | data, hospital emergency department data which shall include the |
1896 | number of patients treated in the emergency department of a |
1897 | licensed hospital reported by patient acuity level, data on |
1898 | hospital-acquired infections as specified by rule, data on |
1899 | complications as specified by rule, data on readmissions as |
1900 | specified by rule, with patient and provider-specific |
1901 | identifiers included, actual charge data by diagnostic groups, |
1902 | financial data, accounting data, operating expenses, expenses |
1903 | incurred for rendering services to patients who cannot or do not |
1904 | pay, interest charges, depreciation expenses based on the |
1905 | expected useful life of the property and equipment involved, and |
1906 | demographic data. The agency shall adopt nationally recognized |
1907 | risk adjustment methodologies or software consistent with the |
1908 | standards of the Agency for Healthcare Research and Quality and |
1909 | as selected by the agency for all data submitted as required by |
1910 | this section. Data may be obtained from documents such as, but |
1911 | not limited to: leases, contracts, debt instruments, itemized |
1912 | patient bills, medical record abstracts, and related diagnostic |
1913 | information. Reported data elements shall be reported |
1914 | electronically and in accordance with rule 59E-7.012, Florida |
1915 | Administrative Code. Data submitted shall be certified |
1916 | chief executive officer or an appropriate and duly authorized |
1917 | representative or employee of the licensed facility that the |
1918 | information submitted is true and accurate. |
1919 | Section 56. Subsection (43) of section 408.07, Florida |
1920 | Statutes, is amended to read: |
1921 | 408.07 Definitions.-As used in this chapter, with the |
1922 | exception of ss. 408.031-408.045, the term: |
1923 | (43) "Rural hospital" means an acute care hospital |
1924 | licensed under chapter 395, having 100 or fewer licensed beds |
1925 | and an emergency room, and which is: |
1926 | (a) The sole provider within a county with a population |
1927 | density of no greater than 100 persons per square mile; |
1928 | (b) An acute care hospital, in a county with a population |
1929 | density of no greater than 100 persons per square mile, which is |
1930 | at least 30 minutes of travel time, on normally traveled roads |
1931 | under normal traffic conditions, from another acute care |
1932 | hospital within the same county; |
1933 | (c) A hospital supported by a tax district or subdistrict |
1934 | whose boundaries encompass a population of 100 persons or fewer |
1935 | per square mile; |
1936 | (d) A hospital with a service area that has a population |
1937 | of 100 persons or fewer per square mile. As used in this |
1938 | paragraph, the term "service area" means the fewest number of |
1939 | zip codes that account for 75 percent of the hospital's |
1940 | discharges for the most recent 5-year period, based on |
1941 | information available from the hospital inpatient discharge |
1942 | database in the Florida Center for Health Information and Policy |
1943 | Analysis at the Agency for Health Care Administration; or |
1944 | (e) A critical access hospital. |
1945 |
|
1946 | Population densities used in this subsection must be based upon |
1947 | the most recently completed United States census. A hospital |
1948 | that received funds under s. 409.9116 for a quarter beginning no |
1949 | later than July 1, 2002, is deemed to have been and shall |
1950 | continue to be a rural hospital from that date through June 30, |
1951 | 2015, if the hospital continues to have 100 or fewer licensed |
1952 | beds and an emergency room, or meets the criteria of s. |
1953 | 395.602(2)(e)4. An acute care hospital that has not previously |
1954 | been designated as a rural hospital and that meets the criteria |
1955 | of this subsection shall be granted such designation upon |
1956 | application, including supporting documentation, to the Agency |
1957 | for Health Care Administration. |
1958 | Section 57. Section 408.10, Florida Statutes, is amended |
1959 | to read: |
1960 | 408.10 Consumer complaints.-The agency shall: |
1961 | (1) publish and make available to the public a toll-free |
1962 | telephone number for the purpose of handling consumer complaints |
1963 | and shall serve as a liaison between consumer entities and other |
1964 | private entities and governmental entities for the disposition |
1965 | of problems identified by consumers of health care. |
1966 | (2) Be empowered to investigate consumer complaints |
1967 | relating to problems with health care facilities' billing |
1968 | practices and issue reports to be made public in any cases where |
1969 | the agency determines the health care facility has engaged in |
1970 | billing practices which are unreasonable and unfair to the |
1971 | consumer. |
1972 | Section 58. Subsections (12) through (30) of section |
1973 | 408.802, Florida Statutes, are renumbered as subsections (11) |
1974 | through (29), respectively, and present subsection (11) of that |
1975 | section is amended to read: |
1976 | 408.802 Applicability.-The provisions of this part apply |
1977 | to the provision of services that require licensure as defined |
1978 | in this part and to the following entities licensed, registered, |
1979 | or certified by the agency, as described in chapters 112, 383, |
1980 | 390, 394, 395, 400, 429, 440, 483, and 765: |
1981 | (11) Private review agents, as provided under part I of |
1982 | chapter 395. |
1983 | Section 59. Subsection (3) is added to section 408.804, |
1984 | Florida Statutes, to read: |
1985 | 408.804 License required; display.- |
1986 | (3) Any person who knowingly alters, defaces, or falsifies |
1987 | a license certificate issued by the agency, or causes or |
1988 | procures any person to commit such an offense, commits a |
1989 | misdemeanor of the second degree, punishable as provided in s. |
1990 | 775.082 or s 775.083. Any licensee or provider who displays an |
1991 | altered, defaced, or falsified license certificate is subject to |
1992 | the penalties set forth in s. 408.815 and an administrative fine |
1993 | of $1,000 for each day of illegal display. |
1994 | Section 60. Paragraph (d) of subsection (2) of section |
1995 | 408.806, Florida Statutes, is amended, present subsections (3) |
1996 | through (8) are renumbered as subsections (4) through (9), |
1997 | respectively, and a new subsection (3) is added to that section, |
1998 | to read: |
1999 | 408.806 License application process.- |
2000 | (2) |
2001 | (d) The agency shall notify the licensee by mail or |
2002 | electronically at least 90 days before the expiration of a |
2003 | license that a renewal license is necessary to continue |
2004 | operation. The licensee's failure to timely file submit a |
2005 | renewal application and license application fee with the agency |
2006 | shall result in a $50 per day late fee charged to the licensee |
2007 | by the agency; however, the aggregate amount of the late fee may |
2008 | not exceed 50 percent of the licensure fee or $500, whichever is |
2009 | less. The agency shall provide a courtesy notice to the licensee |
2010 | by United States mail, electronically, or by any other manner at |
2011 | its address of record or mailing address, if provided, at least |
2012 | 90 days prior to the expiration of a license informing the |
2013 | licensee of the expiration of the license. If the agency does |
2014 | not provide the courtesy notice or the licensee does not receive |
2015 | the courtesy notice, the licensee continues to be legally |
2016 | obligated to timely file the renewal application and license |
2017 | application fee with the agency and is not excused from the |
2018 | payment of a late fee. If an application is received after the |
2019 | required filing date and exhibits a hand-canceled postmark |
2020 | obtained from a United States post office dated on or before the |
2021 | required filing date, no fine will be levied. |
2022 | (3) Payment of the late fee is required to consider any |
2023 | late application complete, and failure to pay the late fee is |
2024 | considered an omission from the application. |
2025 | Section 61. Subsections (6) and (9) of section 408.810, |
2026 | Florida Statutes, are amended to read: |
2027 | 408.810 Minimum licensure requirements.-In addition to the |
2028 | licensure requirements specified in this part, authorizing |
2029 | statutes, and applicable rules, each applicant and licensee must |
2030 | comply with the requirements of this section in order to obtain |
2031 | and maintain a license. |
2032 | (6)(a) An applicant must provide the agency with proof of |
2033 | the applicant's legal right to occupy the property before a |
2034 | license may be issued. Proof may include, but need not be |
2035 | limited to, copies of warranty deeds, lease or rental |
2036 | agreements, contracts for deeds, quitclaim deeds, or other such |
2037 | documentation. |
2038 | (b) In the event the property is encumbered by a mortgage |
2039 | or is leased, an applicant must provide the agency with proof |
2040 | that the mortgagor or landlord has been provided written notice |
2041 | of the applicant's intent as mortgagee or tenant to provide |
2042 | services that require licensure and instruct the mortgagor or |
2043 | landlord to serve the agency by certified mail with copies of |
2044 | any foreclosure or eviction actions initiated by the mortgagor |
2045 | or landlord against the applicant. |
2046 | (9) A controlling interest may not withhold from the |
2047 | agency any evidence of financial instability, including, but not |
2048 | limited to, checks returned due to insufficient funds, |
2049 | delinquent accounts, nonpayment of withholding taxes, unpaid |
2050 | utility expenses, nonpayment for essential services, or adverse |
2051 | court action concerning the financial viability of the provider |
2052 | or any other provider licensed under this part that is under the |
2053 | control of the controlling interest. A controlling interest |
2054 | shall notify the agency within 10 days after a court action to |
2055 | initiate bankruptcy, foreclosure, or eviction proceedings |
2056 | concerning the provider, in which the controlling interest is a |
2057 | petitioner or defendant. Any person who violates this subsection |
2058 | commits a misdemeanor of the second degree, punishable as |
2059 | provided in s. 775.082 or s. 775.083. Each day of continuing |
2060 | violation is a separate offense. |
2061 | Section 62. Subsection (3) is added to section 408.813, |
2062 | Florida Statutes, to read: |
2063 | 408.813 Administrative fines; violations.-As a penalty for |
2064 | any violation of this part, authorizing statutes, or applicable |
2065 | rules, the agency may impose an administrative fine. |
2066 | (3) The agency may impose an administrative fine for a |
2067 | violation that does not qualify as a class I, class II, class |
2068 | III, or class IV violation. Unless otherwise specified by law, |
2069 | the amount of the fine shall not exceed $500 for each violation. |
2070 | Unclassified violations may include: |
2071 | (a) Violating any term or condition of a license. |
2072 | (b) Violating any provision of this part, authorizing |
2073 | statutes, or applicable rules. |
2074 | (c) Exceeding licensed capacity. |
2075 | (d) Providing services beyond the scope of the license. |
2076 | (e) Violating a moratorium imposed pursuant to s. 408.814. |
2077 | Section 63. Subsection (5) is added to section 408.815, |
2078 | Florida Statutes, to read: |
2079 | 408.815 License or application denial; revocation.- |
2080 | (5) In order to ensure the health, safety, and welfare of |
2081 | clients when a license has been denied, revoked, or is set to |
2082 | terminate, the agency may extend the license expiration date for |
2083 | a period of up to 30 days for the sole purpose of allowing the |
2084 | safe and orderly discharge of clients. The agency may impose |
2085 | conditions on the extension, including, but not limited to, |
2086 | prohibiting or limiting admissions, expedited discharge |
2087 | planning, required status reports, and mandatory monitoring by |
2088 | the agency or third parties. In imposing these conditions, the |
2089 | agency shall take into consideration the nature and number of |
2090 | clients, the availability and location of acceptable alternative |
2091 | placements, and the ability of the licensee to continue |
2092 | providing care to the clients. The agency may terminate the |
2093 | extension or modify the conditions at any time. This authority |
2094 | is in addition to any other authority granted to the agency |
2095 | under chapter 120, this part, and authorizing statutes but |
2096 | creates no right or entitlement to an extension of a license |
2097 | expiration date. |
2098 | Section 64. Paragraph (k) of subsection (4) of section |
2099 | 409.221, Florida Statutes, is amended to read: |
2100 | 409.221 Consumer-directed care program.- |
2101 | (4) CONSUMER-DIRECTED CARE.- |
2102 | (k) Reviews and reports.-The agency and the Departments of |
2103 | Elderly Affairs, Health, and Children and Family Services and |
2104 | the Agency for Persons with Disabilities shall each, on an |
2105 | ongoing basis, review and assess the implementation of the |
2106 | consumer-directed care program. By January 15 of each year, the |
2107 | agency shall submit a written report to the Legislature that |
2108 | includes each department's review of the program and contains |
2109 | recommendations for improvements to the program. |
2110 | Section 65. Subsection (1) of section 409.91196, Florida |
2111 | Statutes, is amended to read: |
2112 | 409.91196 Supplemental rebate agreements; public records |
2113 | and public meetings exemption.- |
2114 | (1) The rebate amount, percent of rebate, manufacturer's |
2115 | pricing, and supplemental rebate, and other trade secrets as |
2116 | defined in s. 688.002 that the agency has identified for use in |
2117 | negotiations, held by the Agency for Health Care Administration |
2118 | under s. 409.912(39)(a)8.7. are confidential and exempt from s. |
2119 | 119.07(1) and s. 24(a), Art. I of the State Constitution. |
2120 | Section 66. Paragraph (a) of subsection (39) of section |
2121 | 409.912, Florida Statutes, is amended to read: |
2122 | 409.912 Cost-effective purchasing of health care.-The |
2123 | agency shall purchase goods and services for Medicaid recipients |
2124 | in the most cost-effective manner consistent with the delivery |
2125 | of quality medical care. To ensure that medical services are |
2126 | effectively utilized, the agency may, in any case, require a |
2127 | confirmation or second physician's opinion of the correct |
2128 | diagnosis for purposes of authorizing future services under the |
2129 | Medicaid program. This section does not restrict access to |
2130 | emergency services or poststabilization care services as defined |
2131 | in 42 C.F.R. part 438.114. Such confirmation or second opinion |
2132 | shall be rendered in a manner approved by the agency. The agency |
2133 | shall maximize the use of prepaid per capita and prepaid |
2134 | aggregate fixed-sum basis services when appropriate and other |
2135 | alternative service delivery and reimbursement methodologies, |
2136 | including competitive bidding pursuant to s. 287.057, designed |
2137 | to facilitate the cost-effective purchase of a case-managed |
2138 | continuum of care. The agency shall also require providers to |
2139 | minimize the exposure of recipients to the need for acute |
2140 | inpatient, custodial, and other institutional care and the |
2141 | inappropriate or unnecessary use of high-cost services. The |
2142 | agency shall contract with a vendor to monitor and evaluate the |
2143 | clinical practice patterns of providers in order to identify |
2144 | trends that are outside the normal practice patterns of a |
2145 | provider's professional peers or the national guidelines of a |
2146 | provider's professional association. The vendor must be able to |
2147 | provide information and counseling to a provider whose practice |
2148 | patterns are outside the norms, in consultation with the agency, |
2149 | to improve patient care and reduce inappropriate utilization. |
2150 | The agency may mandate prior authorization, drug therapy |
2151 | management, or disease management participation for certain |
2152 | populations of Medicaid beneficiaries, certain drug classes, or |
2153 | particular drugs to prevent fraud, abuse, overuse, and possible |
2154 | dangerous drug interactions. The Pharmaceutical and Therapeutics |
2155 | Committee shall make recommendations to the agency on drugs for |
2156 | which prior authorization is required. The agency shall inform |
2157 | the Pharmaceutical and Therapeutics Committee of its decisions |
2158 | regarding drugs subject to prior authorization. The agency is |
2159 | authorized to limit the entities it contracts with or enrolls as |
2160 | Medicaid providers by developing a provider network through |
2161 | provider credentialing. The agency may competitively bid single- |
2162 | source-provider contracts if procurement of goods or services |
2163 | results in demonstrated cost savings to the state without |
2164 | limiting access to care. The agency may limit its network based |
2165 | on the assessment of beneficiary access to care, provider |
2166 | availability, provider quality standards, time and distance |
2167 | standards for access to care, the cultural competence of the |
2168 | provider network, demographic characteristics of Medicaid |
2169 | beneficiaries, practice and provider-to-beneficiary standards, |
2170 | appointment wait times, beneficiary use of services, provider |
2171 | turnover, provider profiling, provider licensure history, |
2172 | previous program integrity investigations and findings, peer |
2173 | review, provider Medicaid policy and billing compliance records, |
2174 | clinical and medical record audits, and other factors. Providers |
2175 | shall not be entitled to enrollment in the Medicaid provider |
2176 | network. The agency shall determine instances in which allowing |
2177 | Medicaid beneficiaries to purchase durable medical equipment and |
2178 | other goods is less expensive to the Medicaid program than long- |
2179 | term rental of the equipment or goods. The agency may establish |
2180 | rules to facilitate purchases in lieu of long-term rentals in |
2181 | order to protect against fraud and abuse in the Medicaid program |
2182 | as defined in s. 409.913. The agency may seek federal waivers |
2183 | necessary to administer these policies. |
2184 | (39)(a) The agency shall implement a Medicaid prescribed- |
2185 | drug spending-control program that includes the following |
2186 | components: |
2187 | 1. A Medicaid preferred drug list, which shall be a |
2188 | listing of cost-effective therapeutic options recommended by the |
2189 | Medicaid Pharmacy and Therapeutics Committee established |
2190 | pursuant to s. 409.91195 and adopted by the agency for each |
2191 | therapeutic class on the preferred drug list. At the discretion |
2192 | of the committee, and when feasible, the preferred drug list |
2193 | should include at least two products in a therapeutic class. The |
2194 | agency may post the preferred drug list and updates to the |
2195 | preferred drug list on an Internet website without following the |
2196 | rulemaking procedures of chapter 120. Antiretroviral agents are |
2197 | excluded from the preferred drug list. The agency shall also |
2198 | limit the amount of a prescribed drug dispensed to no more than |
2199 | a 34-day supply unless the drug products' smallest marketed |
2200 | package is greater than a 34-day supply, or the drug is |
2201 | determined by the agency to be a maintenance drug in which case |
2202 | a 100-day maximum supply may be authorized. The agency is |
2203 | authorized to seek any federal waivers necessary to implement |
2204 | these cost-control programs and to continue participation in the |
2205 | federal Medicaid rebate program, or alternatively to negotiate |
2206 | state-only manufacturer rebates. The agency may adopt rules to |
2207 | implement this subparagraph. The agency shall continue to |
2208 | provide unlimited contraceptive drugs and items. The agency must |
2209 | establish procedures to ensure that: |
2210 | a. There is a response to a request for prior consultation |
2211 | by telephone or other telecommunication device within 24 hours |
2212 | after receipt of a request for prior consultation; and |
2213 | b. A 72-hour supply of the drug prescribed is provided in |
2214 | an emergency or when the agency does not provide a response |
2215 | within 24 hours as required by sub-subparagraph a. |
2216 | 2. Reimbursement to pharmacies for Medicaid prescribed |
2217 | drugs shall be set at the lesser of: the average wholesale price |
2218 | (AWP) minus 16.4 percent, the wholesaler acquisition cost (WAC) |
2219 | plus 4.75 percent, the federal upper limit (FUL), the state |
2220 | maximum allowable cost (SMAC), or the usual and customary (UAC) |
2221 | charge billed by the provider. |
2222 | 3. For a prescribed drug billed as a 340B prescribed |
2223 | medication, the claim must meet the requirements of the Deficit |
2224 | Reduction Act of 2005 and the federal 340B program, contain a |
2225 | national drug code, and be billed at the actual acquisition cost |
2226 | or payment shall be denied. |
2227 | 4.3. The agency shall develop and implement a process for |
2228 | managing the drug therapies of Medicaid recipients who are using |
2229 | significant numbers of prescribed drugs each month. The |
2230 | management process may include, but is not limited to, |
2231 | comprehensive, physician-directed medical-record reviews, claims |
2232 | analyses, and case evaluations to determine the medical |
2233 | necessity and appropriateness of a patient's treatment plan and |
2234 | drug therapies. The agency may contract with a private |
2235 | organization to provide drug-program-management services. The |
2236 | Medicaid drug benefit management program shall include |
2237 | initiatives to manage drug therapies for HIV/AIDS patients, |
2238 | patients using 20 or more unique prescriptions in a 180-day |
2239 | period, and the top 1,000 patients in annual spending. The |
2240 | agency shall enroll any Medicaid recipient in the drug benefit |
2241 | management program if he or she meets the specifications of this |
2242 | provision and is not enrolled in a Medicaid health maintenance |
2243 | organization. |
2244 | 5.4. The agency may limit the size of its pharmacy network |
2245 | based on need, competitive bidding, price negotiations, |
2246 | credentialing, or similar criteria. The agency shall give |
2247 | special consideration to rural areas in determining the size and |
2248 | location of pharmacies included in the Medicaid pharmacy |
2249 | network. A pharmacy credentialing process may include criteria |
2250 | such as a pharmacy's full-service status, location, size, |
2251 | patient educational programs, patient consultation, disease |
2252 | management services, and other characteristics. The agency may |
2253 | impose a moratorium on Medicaid pharmacy enrollment when it is |
2254 | determined that it has a sufficient number of Medicaid- |
2255 | participating providers. The agency must allow dispensing |
2256 | practitioners to participate as a part of the Medicaid pharmacy |
2257 | network regardless of the practitioner's proximity to any other |
2258 | entity that is dispensing prescription drugs under the Medicaid |
2259 | program. A dispensing practitioner must meet all credentialing |
2260 | requirements applicable to his or her practice, as determined by |
2261 | the agency. |
2262 | 6.5. The agency shall develop and implement a program that |
2263 | requires Medicaid practitioners who prescribe drugs to use a |
2264 | counterfeit-proof prescription pad for Medicaid prescriptions. |
2265 | The agency shall require the use of standardized counterfeit- |
2266 | proof prescription pads by Medicaid-participating prescribers or |
2267 | prescribers who write prescriptions for Medicaid recipients. The |
2268 | agency may implement the program in targeted geographic areas or |
2269 | statewide. |
2270 | 7.6. The agency may enter into arrangements that require |
2271 | manufacturers of generic drugs prescribed to Medicaid recipients |
2272 | to provide rebates of at least 15.1 percent of the average |
2273 | manufacturer price for the manufacturer's generic products. |
2274 | These arrangements shall require that if a generic-drug |
2275 | manufacturer pays federal rebates for Medicaid-reimbursed drugs |
2276 | at a level below 15.1 percent, the manufacturer must provide a |
2277 | supplemental rebate to the state in an amount necessary to |
2278 | achieve a 15.1-percent rebate level. |
2279 | 8.7. The agency may establish a preferred drug list as |
2280 | described in this subsection, and, pursuant to the establishment |
2281 | of such preferred drug list, it is authorized to negotiate |
2282 | supplemental rebates from manufacturers that are in addition to |
2283 | those required by Title XIX of the Social Security Act and at no |
2284 | less than 14 percent of the average manufacturer price as |
2285 | defined in 42 U.S.C. s. 1936 on the last day of a quarter unless |
2286 | the federal or supplemental rebate, or both, equals or exceeds |
2287 | 29 percent. There is no upper limit on the supplemental rebates |
2288 | the agency may negotiate. The agency may determine that specific |
2289 | products, brand-name or generic, are competitive at lower rebate |
2290 | percentages. Agreement to pay the minimum supplemental rebate |
2291 | percentage will guarantee a manufacturer that the Medicaid |
2292 | Pharmaceutical and Therapeutics Committee will consider a |
2293 | product for inclusion on the preferred drug list. However, a |
2294 | pharmaceutical manufacturer is not guaranteed placement on the |
2295 | preferred drug list by simply paying the minimum supplemental |
2296 | rebate. Agency decisions will be made on the clinical efficacy |
2297 | of a drug and recommendations of the Medicaid Pharmaceutical and |
2298 | Therapeutics Committee, as well as the price of competing |
2299 | products minus federal and state rebates. The agency is |
2300 | authorized to contract with an outside agency or contractor to |
2301 | conduct negotiations for supplemental rebates. For the purposes |
2302 | of this section, the term "supplemental rebates" means cash |
2303 | rebates. Effective July 1, 2004, value-added programs as a |
2304 | substitution for supplemental rebates are prohibited. The agency |
2305 | is authorized to seek any federal waivers to implement this |
2306 | initiative. |
2307 | 9.8. The Agency for Health Care Administration shall |
2308 | expand home delivery of pharmacy products. To assist Medicaid |
2309 | patients in securing their prescriptions and reduce program |
2310 | costs, the agency shall expand its current mail-order-pharmacy |
2311 | diabetes-supply program to include all generic and brand-name |
2312 | drugs used by Medicaid patients with diabetes. Medicaid |
2313 | recipients in the current program may obtain nondiabetes drugs |
2314 | on a voluntary basis. This initiative is limited to the |
2315 | geographic area covered by the current contract. The agency may |
2316 | seek and implement any federal waivers necessary to implement |
2317 | this subparagraph. |
2318 | 10.9. The agency shall limit to one dose per month any |
2319 | drug prescribed to treat erectile dysfunction. |
2320 | 11.10.a. The agency may implement a Medicaid behavioral |
2321 | drug management system. The agency may contract with a vendor |
2322 | that has experience in operating behavioral drug management |
2323 | systems to implement this program. The agency is authorized to |
2324 | seek federal waivers to implement this program. |
2325 | b. The agency, in conjunction with the Department of |
2326 | Children and Family Services, may implement the Medicaid |
2327 | behavioral drug management system that is designed to improve |
2328 | the quality of care and behavioral health prescribing practices |
2329 | based on best practice guidelines, improve patient adherence to |
2330 | medication plans, reduce clinical risk, and lower prescribed |
2331 | drug costs and the rate of inappropriate spending on Medicaid |
2332 | behavioral drugs. The program may include the following |
2333 | elements: |
2334 | (I) Provide for the development and adoption of best |
2335 | practice guidelines for behavioral health-related drugs such as |
2336 | antipsychotics, antidepressants, and medications for treating |
2337 | bipolar disorders and other behavioral conditions; translate |
2338 | them into practice; review behavioral health prescribers and |
2339 | compare their prescribing patterns to a number of indicators |
2340 | that are based on national standards; and determine deviations |
2341 | from best practice guidelines. |
2342 | (II) Implement processes for providing feedback to and |
2343 | educating prescribers using best practice educational materials |
2344 | and peer-to-peer consultation. |
2345 | (III) Assess Medicaid beneficiaries who are outliers in |
2346 | their use of behavioral health drugs with regard to the numbers |
2347 | and types of drugs taken, drug dosages, combination drug |
2348 | therapies, and other indicators of improper use of behavioral |
2349 | health drugs. |
2350 | (IV) Alert prescribers to patients who fail to refill |
2351 | prescriptions in a timely fashion, are prescribed multiple same- |
2352 | class behavioral health drugs, and may have other potential |
2353 | medication problems. |
2354 | (V) Track spending trends for behavioral health drugs and |
2355 | deviation from best practice guidelines. |
2356 | (VI) Use educational and technological approaches to |
2357 | promote best practices, educate consumers, and train prescribers |
2358 | in the use of practice guidelines. |
2359 | (VII) Disseminate electronic and published materials. |
2360 | (VIII) Hold statewide and regional conferences. |
2361 | (IX) Implement a disease management program with a model |
2362 | quality-based medication component for severely mentally ill |
2363 | individuals and emotionally disturbed children who are high |
2364 | users of care. |
2365 | 12.11.a. The agency shall implement a Medicaid |
2366 | prescription drug management system. The agency may contract |
2367 | with a vendor that has experience in operating prescription drug |
2368 | management systems in order to implement this system. Any |
2369 | management system that is implemented in accordance with this |
2370 | subparagraph must rely on cooperation between physicians and |
2371 | pharmacists to determine appropriate practice patterns and |
2372 | clinical guidelines to improve the prescribing, dispensing, and |
2373 | use of drugs in the Medicaid program. The agency may seek |
2374 | federal waivers to implement this program. |
2375 | b. The drug management system must be designed to improve |
2376 | the quality of care and prescribing practices based on best |
2377 | practice guidelines, improve patient adherence to medication |
2378 | plans, reduce clinical risk, and lower prescribed drug costs and |
2379 | the rate of inappropriate spending on Medicaid prescription |
2380 | drugs. The program must: |
2381 | (I) Provide for the development and adoption of best |
2382 | practice guidelines for the prescribing and use of drugs in the |
2383 | Medicaid program, including translating best practice guidelines |
2384 | into practice; reviewing prescriber patterns and comparing them |
2385 | to indicators that are based on national standards and practice |
2386 | patterns of clinical peers in their community, statewide, and |
2387 | nationally; and determine deviations from best practice |
2388 | guidelines. |
2389 | (II) Implement processes for providing feedback to and |
2390 | educating prescribers using best practice educational materials |
2391 | and peer-to-peer consultation. |
2392 | (III) Assess Medicaid recipients who are outliers in their |
2393 | use of a single or multiple prescription drugs with regard to |
2394 | the numbers and types of drugs taken, drug dosages, combination |
2395 | drug therapies, and other indicators of improper use of |
2396 | prescription drugs. |
2397 | (IV) Alert prescribers to patients who fail to refill |
2398 | prescriptions in a timely fashion, are prescribed multiple drugs |
2399 | that may be redundant or contraindicated, or may have other |
2400 | potential medication problems. |
2401 | (V) Track spending trends for prescription drugs and |
2402 | deviation from best practice guidelines. |
2403 | (VI) Use educational and technological approaches to |
2404 | promote best practices, educate consumers, and train prescribers |
2405 | in the use of practice guidelines. |
2406 | (VII) Disseminate electronic and published materials. |
2407 | (VIII) Hold statewide and regional conferences. |
2408 | (IX) Implement disease management programs in cooperation |
2409 | with physicians and pharmacists, along with a model quality- |
2410 | based medication component for individuals having chronic |
2411 | medical conditions. |
2412 | 13.12. The agency is authorized to contract for drug |
2413 | rebate administration, including, but not limited to, |
2414 | calculating rebate amounts, invoicing manufacturers, negotiating |
2415 | disputes with manufacturers, and maintaining a database of |
2416 | rebate collections. |
2417 | 14.13. The agency may specify the preferred daily dosing |
2418 | form or strength for the purpose of promoting best practices |
2419 | with regard to the prescribing of certain drugs as specified in |
2420 | the General Appropriations Act and ensuring cost-effective |
2421 | prescribing practices. |
2422 | 15.14. The agency may require prior authorization for |
2423 | Medicaid-covered prescribed drugs. The agency may, but is not |
2424 | required to, prior-authorize the use of a product: |
2425 | a. For an indication not approved in labeling; |
2426 | b. To comply with certain clinical guidelines; or |
2427 | c. If the product has the potential for overuse, misuse, |
2428 | or abuse. |
2429 |
|
2430 | The agency may require the prescribing professional to provide |
2431 | information about the rationale and supporting medical evidence |
2432 | for the use of a drug. The agency may post prior authorization |
2433 | criteria and protocol and updates to the list of drugs that are |
2434 | subject to prior authorization on an Internet website without |
2435 | amending its rule or engaging in additional rulemaking. |
2436 | 16.15. The agency, in conjunction with the Pharmaceutical |
2437 | and Therapeutics Committee, may require age-related prior |
2438 | authorizations for certain prescribed drugs. The agency may |
2439 | preauthorize the use of a drug for a recipient who may not meet |
2440 | the age requirement or may exceed the length of therapy for use |
2441 | of this product as recommended by the manufacturer and approved |
2442 | by the Food and Drug Administration. Prior authorization may |
2443 | require the prescribing professional to provide information |
2444 | about the rationale and supporting medical evidence for the use |
2445 | of a drug. |
2446 | 17.16. The agency shall implement a step-therapy prior |
2447 | authorization approval process for medications excluded from the |
2448 | preferred drug list. Medications listed on the preferred drug |
2449 | list must be used within the previous 12 months prior to the |
2450 | alternative medications that are not listed. The step-therapy |
2451 | prior authorization may require the prescriber to use the |
2452 | medications of a similar drug class or for a similar medical |
2453 | indication unless contraindicated in the Food and Drug |
2454 | Administration labeling. The trial period between the specified |
2455 | steps may vary according to the medical indication. The step- |
2456 | therapy approval process shall be developed in accordance with |
2457 | the committee as stated in s. 409.91195(7) and (8). A drug |
2458 | product may be approved without meeting the step-therapy prior |
2459 | authorization criteria if the prescribing physician provides the |
2460 | agency with additional written medical or clinical documentation |
2461 | that the product is medically necessary because: |
2462 | a. There is not a drug on the preferred drug list to treat |
2463 | the disease or medical condition which is an acceptable clinical |
2464 | alternative; |
2465 | b. The alternatives have been ineffective in the treatment |
2466 | of the beneficiary's disease; or |
2467 | c. Based on historic evidence and known characteristics of |
2468 | the patient and the drug, the drug is likely to be ineffective, |
2469 | or the number of doses have been ineffective. |
2470 |
|
2471 | The agency shall work with the physician to determine the best |
2472 | alternative for the patient. The agency may adopt rules waiving |
2473 | the requirements for written clinical documentation for specific |
2474 | drugs in limited clinical situations. |
2475 | 18.17. The agency shall implement a return and reuse |
2476 | program for drugs dispensed by pharmacies to institutional |
2477 | recipients, which includes payment of a $5 restocking fee for |
2478 | the implementation and operation of the program. The return and |
2479 | reuse program shall be implemented electronically and in a |
2480 | manner that promotes efficiency. The program must permit a |
2481 | pharmacy to exclude drugs from the program if it is not |
2482 | practical or cost-effective for the drug to be included and must |
2483 | provide for the return to inventory of drugs that cannot be |
2484 | credited or returned in a cost-effective manner. The agency |
2485 | shall determine if the program has reduced the amount of |
2486 | Medicaid prescription drugs which are destroyed on an annual |
2487 | basis and if there are additional ways to ensure more |
2488 | prescription drugs are not destroyed which could safely be |
2489 | reused. The agency's conclusion and recommendations shall be |
2490 | reported to the Legislature by December 1, 2005. |
2491 | Section 67. Subsections (3) and (4) of section 429.07, |
2492 | Florida Statutes, are amended, and subsections (6) and (7) are |
2493 | added to that section, to read: |
2494 | 429.07 License required; fee; inspections.- |
2495 | (3) In addition to the requirements of s. 408.806, each |
2496 | license granted by the agency must state the type of care for |
2497 | which the license is granted. Licenses shall be issued for one |
2498 | or more of the following categories of care: standard, extended |
2499 | congregate care, limited nursing services, or limited mental |
2500 | health. |
2501 | (a) A standard license shall be issued to a facility |
2502 | facilities providing one or more of the personal services |
2503 | identified in s. 429.02. Such licensee facilities may also |
2504 | employ or contract with a person licensed under part I of |
2505 | chapter 464 to administer medications and perform other tasks as |
2506 | specified in s. 429.255. |
2507 | (b) An extended congregate care license shall be issued to |
2508 | a licensee facilities providing, directly or through contract, |
2509 | services beyond those authorized in paragraph (a), including |
2510 | acts performed pursuant to part I of chapter 464 by persons |
2511 | licensed thereunder, and supportive services defined by rule to |
2512 | persons who otherwise would be disqualified from continued |
2513 | residence in a facility licensed under this part. |
2514 | 1. In order for extended congregate care services to be |
2515 | provided in a facility licensed under this part, the agency must |
2516 | first determine that all requirements established in law and |
2517 | rule are met and must specifically designate, on the facility's |
2518 | license, that such services may be provided and whether the |
2519 | designation applies to all or part of a facility. Such |
2520 | designation may be made at the time of initial licensure or |
2521 | relicensure, or upon request in writing by a licensee under this |
2522 | part and part II of chapter 408. Notification of approval or |
2523 | denial of such request shall be made in accordance with part II |
2524 | of chapter 408. An existing licensee facilities qualifying to |
2525 | provide extended congregate care services must have maintained a |
2526 | standard license and may not have been subject to administrative |
2527 | sanctions during the previous 2 years, or since initial |
2528 | licensure if the facility has been licensed for less than 2 |
2529 | years, for any of the following reasons: |
2530 | a. A class I or class II violation; |
2531 | b. Three or more repeat or recurring class III violations |
2532 | of identical or similar resident care standards as specified in |
2533 | rule from which a pattern of noncompliance is found by the |
2534 | agency; |
2535 | c. Three or more class III violations that were not |
2536 | corrected in accordance with the corrective action plan approved |
2537 | by the agency; |
2538 | d. Violation of resident care standards resulting in a |
2539 | requirement to employ the services of a consultant pharmacist or |
2540 | consultant dietitian; |
2541 | e. Denial, suspension, or revocation of a license for |
2542 | another facility under this part in which the applicant for an |
2543 | extended congregate care license has at least 25 percent |
2544 | ownership interest; or |
2545 | f. Imposition of a moratorium pursuant to this part or |
2546 | part II of chapter 408 or initiation of injunctive proceedings. |
2547 | 2. A licensee Facilities that is are licensed to provide |
2548 | extended congregate care services shall maintain a written |
2549 | progress report for on each person who receives such services, |
2550 | and the which report must describe describes the type, amount, |
2551 | duration, scope, and outcome of services that are rendered and |
2552 | the general status of the resident's health. A registered nurse, |
2553 | or appropriate designee, representing the agency shall visit |
2554 | such facilities at least quarterly to monitor residents who are |
2555 | receiving extended congregate care services and to determine if |
2556 | the facility is in compliance with this part, part II of chapter |
2557 | 408, and rules that relate to extended congregate care. One of |
2558 | these visits may be in conjunction with the regular survey. The |
2559 | monitoring visits may be provided through contractual |
2560 | arrangements with appropriate community agencies. A registered |
2561 | nurse shall serve as part of the team that inspects such |
2562 | facility. The agency may waive one of the required yearly |
2563 | monitoring visits for a facility that has been licensed for at |
2564 | least 24 months to provide extended congregate care services, |
2565 | if, during the inspection, the registered nurse determines that |
2566 | extended congregate care services are being provided |
2567 | appropriately, and if the facility has no class I or class II |
2568 | violations and no uncorrected class III violations. Before such |
2569 | decision is made, the agency shall consult with the long-term |
2570 | care ombudsman council for the area in which the facility is |
2571 | located to determine if any complaints have been made and |
2572 | substantiated about the quality of services or care. The agency |
2573 | may not waive one of the required yearly monitoring visits if |
2574 | complaints have been made and substantiated. |
2575 | 3. Licensees Facilities that are licensed to provide |
2576 | extended congregate care services shall: |
2577 | a. Demonstrate the capability to meet unanticipated |
2578 | resident service needs. |
2579 | b. Offer a physical environment that promotes a homelike |
2580 | setting, provides for resident privacy, promotes resident |
2581 | independence, and allows sufficient congregate space as defined |
2582 | by rule. |
2583 | c. Have sufficient staff available, taking into account |
2584 | the physical plant and firesafety features of the building, to |
2585 | assist with the evacuation of residents in an emergency, as |
2586 | necessary. |
2587 | d. Adopt and follow policies and procedures that maximize |
2588 | resident independence, dignity, choice, and decisionmaking to |
2589 | permit residents to age in place to the extent possible, so that |
2590 | moves due to changes in functional status are minimized or |
2591 | avoided. |
2592 | e. Allow residents or, if applicable, a resident's |
2593 | representative, designee, surrogate, guardian, or attorney in |
2594 | fact to make a variety of personal choices, participate in |
2595 | developing service plans, and share responsibility in |
2596 | decisionmaking. |
2597 | f. Implement the concept of managed risk. |
2598 | g. Provide, either directly or through contract, the |
2599 | services of a person licensed pursuant to part I of chapter 464. |
2600 | h. In addition to the training mandated in s. 429.52, |
2601 | provide specialized training as defined by rule for facility |
2602 | staff. |
2603 | 4. Licensees Facilities licensed to provide extended |
2604 | congregate care services are exempt from the criteria for |
2605 | continued residency as set forth in rules adopted under s. |
2606 | 429.41. Licensees Facilities so licensed shall adopt their own |
2607 | requirements within guidelines for continued residency set forth |
2608 | by rule. However, such licensees facilities may not serve |
2609 | residents who require 24-hour nursing supervision. Licensees |
2610 | Facilities licensed to provide extended congregate care services |
2611 | shall provide each resident with a written copy of facility |
2612 | policies governing admission and retention. |
2613 | 5. The primary purpose of extended congregate care |
2614 | services is to allow residents, as they become more impaired, |
2615 | the option of remaining in a familiar setting from which they |
2616 | would otherwise be disqualified for continued residency. A |
2617 | facility licensed to provide extended congregate care services |
2618 | may also admit an individual who exceeds the admission criteria |
2619 | for a facility with a standard license, if the individual is |
2620 | determined appropriate for admission to the extended congregate |
2621 | care facility. |
2622 | 6. Before admission of an individual to a facility |
2623 | licensed to provide extended congregate care services, the |
2624 | individual must undergo a medical examination as provided in s. |
2625 | 429.26(4) and the facility must develop a preliminary service |
2626 | plan for the individual. |
2627 | 7. When a licensee facility can no longer provide or |
2628 | arrange for services in accordance with the resident's service |
2629 | plan and needs and the licensee's facility's policy, the |
2630 | licensee facility shall make arrangements for relocating the |
2631 | person in accordance with s. 429.28(1)(k). |
2632 | 8. Failure to provide extended congregate care services |
2633 | may result in denial of extended congregate care license |
2634 | renewal. |
2635 | 9. No later than January 1 of each year, the department, |
2636 | in consultation with the agency, shall prepare and submit to the |
2637 | Governor, the President of the Senate, the Speaker of the House |
2638 | of Representatives, and the chairs of appropriate legislative |
2639 | committees, a report on the status of, and recommendations |
2640 | related to, extended congregate care services. The status report |
2641 | must include, but need not be limited to, the following |
2642 | information: |
2643 | a. A description of the facilities licensed to provide |
2644 | such services, including total number of beds licensed under |
2645 | this part. |
2646 | b. The number and characteristics of residents receiving |
2647 | such services. |
2648 | c. The types of services rendered that could not be |
2649 | provided through a standard license. |
2650 | d. An analysis of deficiencies cited during licensure |
2651 | inspections. |
2652 | e. The number of residents who required extended |
2653 | congregate care services at admission and the source of |
2654 | admission. |
2655 | f. Recommendations for statutory or regulatory changes. |
2656 | g. The availability of extended congregate care to state |
2657 | clients residing in facilities licensed under this part and in |
2658 | need of additional services, and recommendations for |
2659 | appropriations to subsidize extended congregate care services |
2660 | for such persons. |
2661 | h. Such other information as the department considers |
2662 | appropriate. |
2663 | (c) A limited nursing services license shall be issued to |
2664 | a facility that provides services beyond those authorized in |
2665 | paragraph (a) and as specified in this paragraph. |
2666 | 1. In order for limited nursing services to be provided in |
2667 | a facility licensed under this part, the agency must first |
2668 | determine that all requirements established in law and rule are |
2669 | met and must specifically designate, on the facility's license, |
2670 | that such services may be provided. Such designation may be made |
2671 | at the time of initial licensure or relicensure, or upon request |
2672 | in writing by a licensee under this part and part II of chapter |
2673 | 408. Notification of approval or denial of such request shall be |
2674 | made in accordance with part II of chapter 408. Existing |
2675 | facilities qualifying to provide limited nursing services shall |
2676 | have maintained a standard license and may not have been subject |
2677 | to administrative sanctions that affect the health, safety, and |
2678 | welfare of residents for the previous 2 years or since initial |
2679 | licensure if the facility has been licensed for less than 2 |
2680 | years. |
2681 | 2. Facilities that are licensed to provide limited nursing |
2682 | services shall maintain a written progress report on each person |
2683 | who receives such nursing services, which report describes the |
2684 | type, amount, duration, scope, and outcome of services that are |
2685 | rendered and the general status of the resident's health. A |
2686 | registered nurse representing the agency shall visit such |
2687 | facilities at least twice a year to monitor residents who are |
2688 | receiving limited nursing services and to determine if the |
2689 | facility is in compliance with applicable provisions of this |
2690 | part, part II of chapter 408, and related rules. The monitoring |
2691 | visits may be provided through contractual arrangements with |
2692 | appropriate community agencies. A registered nurse shall also |
2693 | serve as part of the team that inspects such facility. |
2694 | 3. A person who receives limited nursing services under |
2695 | this part must meet the admission criteria established by the |
2696 | agency for assisted living facilities. When a resident no longer |
2697 | meets the admission criteria for a facility licensed under this |
2698 | part, arrangements for relocating the person shall be made in |
2699 | accordance with s. 429.28(1)(k), unless the facility is licensed |
2700 | to provide extended congregate care services. |
2701 | (4) In accordance with s. 408.805, an applicant or |
2702 | licensee shall pay a fee for each license application submitted |
2703 | under this part, part II of chapter 408, and applicable rules. |
2704 | The amount of the fee shall be established by rule. |
2705 | (a) The biennial license fee required of a facility is |
2706 | $356 $300 per license, with an additional fee of $67.50 $50 per |
2707 | resident based on the total licensed resident capacity of the |
2708 | facility, except that no additional fee will be assessed for |
2709 | beds designated for recipients of optional state supplementation |
2710 | payments provided for in s. 409.212. The total fee may not |
2711 | exceed $18,000 $10,000. |
2712 | (b) In addition to the total fee assessed under paragraph |
2713 | (a), the agency shall require facilities that are licensed to |
2714 | provide extended congregate care services under this part to pay |
2715 | an additional fee per licensed facility. The amount of the |
2716 | biennial fee shall be $501 $400 per license, with an additional |
2717 | fee of $10 per resident based on the total licensed resident |
2718 | capacity of the facility. |
2719 | (c) In addition to the total fee assessed under paragraph |
2720 | (a), the agency shall require facilities that are licensed to |
2721 | provide limited nursing services under this part to pay an |
2722 | additional fee per licensed facility. The amount of the biennial |
2723 | fee shall be $250 per license, with an additional fee of $10 per |
2724 | resident based on the total licensed resident capacity of the |
2725 | facility. |
2726 | (6) In order to determine whether the facility is |
2727 | adequately protecting residents' rights as provided in s. |
2728 | 429.28, the biennial survey shall include private informal |
2729 | conversations with a sample of residents and consultation with |
2730 | the ombudsman council in the planning and service area in which |
2731 | the facility is located to discuss residents' experiences within |
2732 | the facility. |
2733 | (7) An assisted living facility that has been cited within |
2734 | the previous 24-month period for a class I or class II |
2735 | violation, regardless of the status of any enforcement or |
2736 | disciplinary action, is subject to periodic unannounced |
2737 | monitoring to determine if the facility is in compliance with |
2738 | this part, part II of chapter 408, and applicable rules. |
2739 | Monitoring may occur through a desk review or an onsite |
2740 | assessment. If the class I or class II violation relates to |
2741 | providing or failing to provide nursing care, a registered nurse |
2742 | must participate in at least two onsite monitoring visits within |
2743 | a 12-month period. |
2744 | Section 68. Subsection (7) of section 429.11, Florida |
2745 | Statutes, is renumbered as subsection (6), and present |
2746 | subsection (6) of that section is amended to read: |
2747 | 429.11 Initial application for license; provisional |
2748 | license.- |
2749 | (6) In addition to the license categories available in s. |
2750 | 408.808, a provisional license may be issued to an applicant |
2751 | making initial application for licensure or making application |
2752 | for a change of ownership. A provisional license shall be |
2753 | limited in duration to a specific period of time not to exceed 6 |
2754 | months, as determined by the agency. |
2755 | Section 69. Section 429.12, Florida Statutes, is amended |
2756 | to read: |
2757 | 429.12 Sale or transfer of ownership of a facility.-It is |
2758 | the intent of the Legislature to protect the rights of the |
2759 | residents of an assisted living facility when the facility is |
2760 | sold or the ownership thereof is transferred. Therefore, in |
2761 | addition to the requirements of part II of chapter 408, whenever |
2762 | a facility is sold or the ownership thereof is transferred, |
2763 | including leasing:. |
2764 | (1) The transferee shall notify the residents, in writing, |
2765 | of the change of ownership within 7 days after receipt of the |
2766 | new license. |
2767 | (2) The transferor of a facility the license of which is |
2768 | denied pending an administrative hearing shall, as a part of the |
2769 | written change-of-ownership contract, advise the transferee that |
2770 | a plan of correction must be submitted by the transferee and |
2771 | approved by the agency at least 7 days before the change of |
2772 | ownership and that failure to correct the condition which |
2773 | resulted in the moratorium pursuant to part II of chapter 408 or |
2774 | denial of licensure is grounds for denial of the transferee's |
2775 | license. |
2776 | Section 70. Paragraphs (b) through (l) of subsection (1) |
2777 | of section 429.14, Florida Statutes, are redesignated as |
2778 | paragraphs (a) through (k), respectively, and present paragraph |
2779 | (a) of subsection (1) and subsections (5) and (6) of that |
2780 | section are amended to read: |
2781 | 429.14 Administrative penalties.- |
2782 | (1) In addition to the requirements of part II of chapter |
2783 | 408, the agency may deny, revoke, and suspend any license issued |
2784 | under this part and impose an administrative fine in the manner |
2785 | provided in chapter 120 against a licensee of an assisted living |
2786 | facility for a violation of any provision of this part, part II |
2787 | of chapter 408, or applicable rules, or for any of the following |
2788 | actions by a licensee of an assisted living facility, for the |
2789 | actions of any person subject to level 2 background screening |
2790 | under s. 408.809, or for the actions of any facility employee: |
2791 | (a) An intentional or negligent act seriously affecting |
2792 | the health, safety, or welfare of a resident of the facility. |
2793 | (5) An action taken by the agency to suspend, deny, or |
2794 | revoke a facility's license under this part or part II of |
2795 | chapter 408, in which the agency claims that the facility owner |
2796 | or an employee of the facility has threatened the health, |
2797 | safety, or welfare of a resident of the facility shall be heard |
2798 | by the Division of Administrative Hearings of the Department of |
2799 | Management Services within 120 days after receipt of the |
2800 | facility's request for a hearing, unless that time limitation is |
2801 | waived by both parties. The administrative law judge must render |
2802 | a decision within 30 days after receipt of a proposed |
2803 | recommended order. |
2804 | (6) The agency shall provide to the Division of Hotels and |
2805 | Restaurants of the Department of Business and Professional |
2806 | Regulation, on a monthly basis, a list of those assisted living |
2807 | facilities that have had their licenses denied, suspended, or |
2808 | revoked or that are involved in an appellate proceeding pursuant |
2809 | to s. 120.60 related to the denial, suspension, or revocation of |
2810 | a license. This information may be provided electronically or |
2811 | through the agency's Internet website. |
2812 | Section 71. Subsections (1), (4), and (5) of section |
2813 | 429.17, Florida Statutes, are amended to read: |
2814 | 429.17 Expiration of license; renewal; conditional |
2815 | license.- |
2816 | (1) Limited nursing, Extended congregate care, and limited |
2817 | mental health licenses shall expire at the same time as the |
2818 | facility's standard license, regardless of when issued. |
2819 | (4) In addition to the license categories available in s. |
2820 | 408.808, a conditional license may be issued to an applicant for |
2821 | license renewal if the applicant fails to meet all standards and |
2822 | requirements for licensure. A conditional license issued under |
2823 | this subsection shall be limited in duration to a specific |
2824 | period of time not to exceed 6 months, as determined by the |
2825 | agency, and shall be accompanied by an agency-approved plan of |
2826 | correction. |
2827 | (5) When an extended congregate care or limited nursing |
2828 | license is requested during a facility's biennial license |
2829 | period, the fee shall be prorated in order to permit the |
2830 | additional license to expire at the end of the biennial license |
2831 | period. The fee shall be calculated as of the date the |
2832 | additional license application is received by the agency. |
2833 | Section 72. Subsection (7) of section 429.19, Florida |
2834 | Statutes, is amended to read: |
2835 | 429.19 Violations; imposition of administrative fines; |
2836 | grounds.- |
2837 | (7) In addition to any administrative fines imposed, the |
2838 | agency may assess a survey or monitoring fee, equal to the |
2839 | lesser of one half of the facility's biennial license and bed |
2840 | fee or $500, to cover the cost of conducting initial complaint |
2841 | investigations that result in the finding of a violation that |
2842 | was the subject of the complaint or to monitor the health, |
2843 | safety, or security of residents under s. 429.07 (7) monitoring |
2844 | visits conducted under s. 429.28(3)(c) to verify the correction |
2845 | of the violations. |
2846 | Section 73. Subsections (6) through (10) of section |
2847 | 429.23, Florida Statutes, are renumbered as subsections (5) |
2848 | through (9), respectively, and present subsection (5) of that |
2849 | section is amended to read: |
2850 | 429.23 Internal risk management and quality assurance |
2851 | program; adverse incidents and reporting requirements.- |
2852 | (5) Each facility shall report monthly to the agency any |
2853 | liability claim filed against it. The report must include the |
2854 | name of the resident, the dates of the incident leading to the |
2855 | claim, if applicable, and the type of injury or violation of |
2856 | rights alleged to have occurred. This report is not discoverable |
2857 | in any civil or administrative action, except in such actions |
2858 | brought by the agency to enforce the provisions of this part. |
2859 | Section 74. Paragraph (a) of subsection (1) and subsection |
2860 | (2) of section 429.255, Florida Statutes, are amended to read: |
2861 | 429.255 Use of personnel; emergency care.- |
2862 | (1)(a) Persons under contract to the facility or, facility |
2863 | staff, or volunteers, who are licensed according to part I of |
2864 | chapter 464, or those persons exempt under s. 464.022(1), and |
2865 | others as defined by rule, may administer medications to |
2866 | residents, take residents' vital signs, manage individual weekly |
2867 | pill organizers for residents who self-administer medication, |
2868 | give prepackaged enemas ordered by a physician, observe |
2869 | residents, document observations on the appropriate resident's |
2870 | record, report observations to the resident's physician, and |
2871 | contract or allow residents or a resident's representative, |
2872 | designee, surrogate, guardian, or attorney in fact to contract |
2873 | with a third party, provided residents meet the criteria for |
2874 | appropriate placement as defined in s. 429.26. Persons under |
2875 | contract to the facility or facility staff who are licensed |
2876 | according to part I of chapter 464 may provide limited nursing |
2877 | services. Nursing assistants certified pursuant to part II of |
2878 | chapter 464 may take residents' vital signs as directed by a |
2879 | licensed nurse or physician. The facility is responsible for |
2880 | maintaining documentation of services provided under this |
2881 | paragraph as required by rule and ensuring that staff are |
2882 | adequately trained to monitor residents receiving these |
2883 | services. |
2884 | (2) In facilities licensed to provide extended congregate |
2885 | care, persons under contract to the facility or, facility staff, |
2886 | or volunteers, who are licensed according to part I of chapter |
2887 | 464, or those persons exempt under s. 464.022(1), or those |
2888 | persons certified as nursing assistants pursuant to part II of |
2889 | chapter 464, may also perform all duties within the scope of |
2890 | their license or certification, as approved by the facility |
2891 | administrator and pursuant to this part. |
2892 | Section 75. Subsection (3) of section 429.28, Florida |
2893 | Statutes, is amended to read: |
2894 | 429.28 Resident bill of rights.- |
2895 | (3)(a) The agency shall conduct a survey to determine |
2896 | general compliance with facility standards and compliance with |
2897 | residents' rights as a prerequisite to initial licensure or |
2898 | licensure renewal. |
2899 | (b) In order to determine whether the facility is |
2900 | adequately protecting residents' rights, the biennial survey |
2901 | shall include private informal conversations with a sample of |
2902 | residents and consultation with the ombudsman council in the |
2903 | planning and service area in which the facility is located to |
2904 | discuss residents' experiences within the facility. |
2905 | (c) During any calendar year in which no survey is |
2906 | conducted, the agency shall conduct at least one monitoring |
2907 | visit of each facility cited in the previous year for a class I |
2908 | or class II violation, or more than three uncorrected class III |
2909 | violations. |
2910 | (d) The agency may conduct periodic followup inspections |
2911 | as necessary to monitor the compliance of facilities with a |
2912 | history of any class I, class II, or class III violations that |
2913 | threaten the health, safety, or security of residents. |
2914 | (e) The agency may conduct complaint investigations as |
2915 | warranted to investigate any allegations of noncompliance with |
2916 | requirements required under this part or rules adopted under |
2917 | this part. |
2918 | Section 76. Subsection (2) of section 429.35, Florida |
2919 | Statutes, is amended to read: |
2920 | 429.35 Maintenance of records; reports.- |
2921 | (2) Within 60 days after the date of the biennial |
2922 | inspection visit required under s. 408.811 or within 30 days |
2923 | after the date of any interim visit, the agency shall forward |
2924 | the results of the inspection to the local ombudsman council in |
2925 | whose planning and service area, as defined in part II of |
2926 | chapter 400, the facility is located; to at least one public |
2927 | library or, in the absence of a public library, the county seat |
2928 | in the county in which the inspected assisted living facility is |
2929 | located; and, when appropriate, to the district Adult Services |
2930 | and Mental Health Program Offices. This information may be |
2931 | provided electronically or through the agency's Internet |
2932 | website. |
2933 | Section 77. Paragraphs (i) and (j) of subsection (1) of |
2934 | section 429.41, Florida Statutes, are amended to read: |
2935 | 429.41 Rules establishing standards.- |
2936 | (1) It is the intent of the Legislature that rules |
2937 | published and enforced pursuant to this section shall include |
2938 | criteria by which a reasonable and consistent quality of |
2939 | resident care and quality of life may be ensured and the results |
2940 | of such resident care may be demonstrated. Such rules shall also |
2941 | ensure a safe and sanitary environment that is residential and |
2942 | noninstitutional in design or nature. It is further intended |
2943 | that reasonable efforts be made to accommodate the needs and |
2944 | preferences of residents to enhance the quality of life in a |
2945 | facility. The agency, in consultation with the department, may |
2946 | adopt rules to administer the requirements of part II of chapter |
2947 | 408. In order to provide safe and sanitary facilities and the |
2948 | highest quality of resident care accommodating the needs and |
2949 | preferences of residents, the department, in consultation with |
2950 | the agency, the Department of Children and Family Services, and |
2951 | the Department of Health, shall adopt rules, policies, and |
2952 | procedures to administer this part, which must include |
2953 | reasonable and fair minimum standards in relation to: |
2954 | (i) Facilities holding an a limited nursing, extended |
2955 | congregate care, or limited mental health license. |
2956 | (j) The establishment of specific criteria to define |
2957 | appropriateness of resident admission and continued residency in |
2958 | a facility holding a standard, limited nursing, extended |
2959 | congregate care, and limited mental health license. |
2960 | Section 78. Subsections (1) and (2) of section 429.53, |
2961 | Florida Statutes, are amended to read: |
2962 | 429.53 Consultation by the agency.- |
2963 | (1) The area offices of licensure and certification of the |
2964 | agency shall provide consultation to the following upon request: |
2965 | (a) A licensee of a facility. |
2966 | (b) A person interested in obtaining a license to operate |
2967 | a facility under this part. |
2968 | (2) As used in this section, "consultation" includes: |
2969 | (a) An explanation of the requirements of this part and |
2970 | rules adopted pursuant thereto; |
2971 | (b) An explanation of the license application and renewal |
2972 | procedures; |
2973 | (c) The provision of a checklist of general local and |
2974 | state approvals required prior to constructing or developing a |
2975 | facility and a listing of the types of agencies responsible for |
2976 | such approvals; |
2977 | (d) An explanation of benefits and financial assistance |
2978 | available to a recipient of supplemental security income |
2979 | residing in a facility; |
2980 | (c)(e) Any other information which the agency deems |
2981 | necessary to promote compliance with the requirements of this |
2982 | part; and |
2983 | (f) A preconstruction review of a facility to ensure |
2984 | compliance with agency rules and this part. |
2985 | Section 79. Subsections (1) and (2) of section 429.54, |
2986 | Florida Statutes, are renumbered as subsections (2) and (3), |
2987 | respectively, and a new subsection (1) is added to that section |
2988 | to read: |
2989 | 429.54 Collection of information; local subsidy.- |
2990 | (1) A facility that is licensed under this part must |
2991 | report electronically to the agency semiannually data related to |
2992 | the facility, including, but not limited to, the total number of |
2993 | residents, the number of residents who are receiving limited |
2994 | mental health services, the number of residents who are |
2995 | receiving extended congregate care services, the number of |
2996 | residents who are receiving limited nursing services, and |
2997 | professional staffing employed by or under contract with the |
2998 | licensee to provide resident services. The department, in |
2999 | consultation with the agency, shall adopt rules to administer |
3000 | this subsection. |
3001 | Section 80. Subsections (1) and (5) of section 429.71, |
3002 | Florida Statutes, are amended to read: |
3003 | 429.71 Classification of violations deficiencies; |
3004 | administrative fines.- |
3005 | (1) In addition to the requirements of part II of chapter |
3006 | 408 and in addition to any other liability or penalty provided |
3007 | by law, the agency may impose an administrative fine on a |
3008 | provider according to the following classification: |
3009 | (a) Class I violations are defined in s. 408.813 those |
3010 | conditions or practices related to the operation and maintenance |
3011 | of an adult family-care home or to the care of residents which |
3012 | the agency determines present an imminent danger to the |
3013 | residents or guests of the facility or a substantial probability |
3014 | that death or serious physical or emotional harm would result |
3015 | therefrom. The condition or practice that constitutes a class I |
3016 | violation must be abated or eliminated within 24 hours, unless a |
3017 | fixed period, as determined by the agency, is required for |
3018 | correction. A class I violation deficiency is subject to an |
3019 | administrative fine in an amount not less than $500 and not |
3020 | exceeding $1,000 for each violation. A fine may be levied |
3021 | notwithstanding the correction of the deficiency. |
3022 | (b) Class II violations are defined in s. 408.813 those |
3023 | conditions or practices related to the operation and maintenance |
3024 | of an adult family-care home or to the care of residents which |
3025 | the agency determines directly threaten the physical or |
3026 | emotional health, safety, or security of the residents, other |
3027 | than class I violations. A class II violation is subject to an |
3028 | administrative fine in an amount not less than $250 and not |
3029 | exceeding $500 for each violation. A citation for a class II |
3030 | violation must specify the time within which the violation is |
3031 | required to be corrected. If a class II violation is corrected |
3032 | within the time specified, no civil penalty shall be imposed, |
3033 | unless it is a repeated offense. |
3034 | (c) Class III violations are defined in s. 408.813 those |
3035 | conditions or practices related to the operation and maintenance |
3036 | of an adult family-care home or to the care of residents which |
3037 | the agency determines indirectly or potentially threaten the |
3038 | physical or emotional health, safety, or security of residents, |
3039 | other than class I or class II violations. A class III violation |
3040 | is subject to an administrative fine in an amount not less than |
3041 | $100 and not exceeding $250 for each violation. A citation for a |
3042 | class III violation shall specify the time within which the |
3043 | violation is required to be corrected. If a class III violation |
3044 | is corrected within the time specified, no civil penalty shall |
3045 | be imposed, unless it is a repeated violation offense. |
3046 | (d) Class IV violations are defined in s. 408.813 those |
3047 | conditions or occurrences related to the operation and |
3048 | maintenance of an adult family-care home, or related to the |
3049 | required reports, forms, or documents, which do not have the |
3050 | potential of negatively affecting the residents. A provider that |
3051 | does not correct A class IV violation within the time limit |
3052 | specified by the agency is subject to an administrative fine in |
3053 | an amount not less than $50 and not exceeding $100 for each |
3054 | violation. Any class IV violation that is corrected during the |
3055 | time the agency survey is conducted will be identified as an |
3056 | agency finding and not as a violation, unless it is a repeat |
3057 | violation. |
3058 | (5) As an alternative to or in conjunction with an |
3059 | administrative action against a provider, the agency may request |
3060 | a plan of corrective action that demonstrates a good faith |
3061 | effort to remedy each violation by a specific date, subject to |
3062 | the approval of the agency. |
3063 | Section 81. Paragraphs (b) through (e) of subsection (2) |
3064 | of section 429.911, Florida Statutes, are redesignated as |
3065 | paragraphs (a) through (d), respectively, and present paragraph |
3066 | (a) of that subsection is amended to read: |
3067 | 429.911 Denial, suspension, revocation of license; |
3068 | emergency action; administrative fines; investigations and |
3069 | inspections.- |
3070 | (2) Each of the following actions by the owner of an adult |
3071 | day care center or by its operator or employee is a ground for |
3072 | action by the agency against the owner of the center or its |
3073 | operator or employee: |
3074 | (a) An intentional or negligent act materially affecting |
3075 | the health or safety of center participants. |
3076 | Section 82. Section 429.915, Florida Statutes, is amended |
3077 | to read: |
3078 | 429.915 Conditional license.-In addition to the license |
3079 | categories available in part II of chapter 408, the agency may |
3080 | issue a conditional license to an applicant for license renewal |
3081 | or change of ownership if the applicant fails to meet all |
3082 | standards and requirements for licensure. A conditional license |
3083 | issued under this subsection must be limited to a specific |
3084 | period not exceeding 6 months, as determined by the agency, and |
3085 | must be accompanied by an approved plan of correction. |
3086 | Section 83. Paragraphs (b) and (h) of subsection (3) of |
3087 | section 430.80, Florida Statutes, are amended to read: |
3088 | 430.80 Implementation of a teaching nursing home pilot |
3089 | project.- |
3090 | (3) To be designated as a teaching nursing home, a nursing |
3091 | home licensee must, at a minimum: |
3092 | (b) Participate in a nationally recognized accreditation |
3093 | program and hold a valid accreditation, such as the |
3094 | accreditation awarded by The Joint Commission on Accreditation |
3095 | of Healthcare Organizations; |
3096 | (h) Maintain insurance coverage pursuant to s. |
3097 | 400.141(1)(q)(s) or proof of financial responsibility in a |
3098 | minimum amount of $750,000. Such proof of financial |
3099 | responsibility may include: |
3100 | 1. Maintaining an escrow account consisting of cash or |
3101 | assets eligible for deposit in accordance with s. 625.52; or |
3102 | 2. Obtaining and maintaining pursuant to chapter 675 an |
3103 | unexpired, irrevocable, nontransferable and nonassignable letter |
3104 | of credit issued by any bank or savings association organized |
3105 | and existing under the laws of this state or any bank or savings |
3106 | association organized under the laws of the United States that |
3107 | has its principal place of business in this state or has a |
3108 | branch office which is authorized to receive deposits in this |
3109 | state. The letter of credit shall be used to satisfy the |
3110 | obligation of the facility to the claimant upon presentment of a |
3111 | final judgment indicating liability and awarding damages to be |
3112 | paid by the facility or upon presentment of a settlement |
3113 | agreement signed by all parties to the agreement when such final |
3114 | judgment or settlement is a result of a liability claim against |
3115 | the facility. |
3116 | Section 84. Paragraph (a) of subsection (2) of section |
3117 | 440.13, Florida Statutes, is amended to read: |
3118 | 440.13 Medical services and supplies; penalty for |
3119 | violations; limitations.- |
3120 | (2) MEDICAL TREATMENT; DUTY OF EMPLOYER TO FURNISH.- |
3121 | (a) Subject to the limitations specified elsewhere in this |
3122 | chapter, the employer shall furnish to the employee such |
3123 | medically necessary remedial treatment, care, and attendance for |
3124 | such period as the nature of the injury or the process of |
3125 | recovery may require, which is in accordance with established |
3126 | practice parameters and protocols of treatment as provided for |
3127 | in this chapter, including medicines, medical supplies, durable |
3128 | medical equipment, orthoses, prostheses, and other medically |
3129 | necessary apparatus. Remedial treatment, care, and attendance, |
3130 | including work-hardening programs or pain-management programs |
3131 | accredited by the Commission on Accreditation of Rehabilitation |
3132 | Facilities or The Joint Commission on the Accreditation of |
3133 | Health Organizations or pain-management programs affiliated with |
3134 | medical schools, shall be considered as covered treatment only |
3135 | when such care is given based on a referral by a physician as |
3136 | defined in this chapter. Medically necessary treatment, care, |
3137 | and attendance does not include chiropractic services in excess |
3138 | of 24 treatments or rendered 12 weeks beyond the date of the |
3139 | initial chiropractic treatment, whichever comes first, unless |
3140 | the carrier authorizes additional treatment or the employee is |
3141 | catastrophically injured. |
3142 |
|
3143 | Failure of the carrier to timely comply with this subsection |
3144 | shall be a violation of this chapter and the carrier shall be |
3145 | subject to penalties as provided for in s. 440.525. |
3146 | Section 85. Section 483.294, Florida Statutes, is amended |
3147 | to read: |
3148 | 483.294 Inspection of centers.-In accordance with s. |
3149 | 408.811, the agency shall biennially, at least once annually, |
3150 | inspect the premises and operations of all centers subject to |
3151 | licensure under this part. |
3152 | Section 86. Subsections (32) through (54) of section |
3153 | 499.003, Florida Statutes, are renumbered as subsections (33) |
3154 | through (55), respectively, present subsection (42) and |
3155 | paragraph (a) of present subsection (53) are amended, and a new |
3156 | subsection (32) is added to that subsection, to read: |
3157 | 499.003 Definitions of terms used in this part.-As used in |
3158 | this part, the term: |
3159 | (32) "Medical convenience kit" means packages or units |
3160 | that contain combination products as defined in 21 C.F.R. s. |
3161 | 3.2(e)(2). |
3162 | (43)(42) "Prescription drug" means a prescription, |
3163 | medicinal, or legend drug, including, but not limited to, |
3164 | finished dosage forms or active ingredients subject to, defined |
3165 | by, or described by s. 503(b) of the Federal Food, Drug, and |
3166 | Cosmetic Act or s. 465.003(8), s. 499.007(13), or subsection |
3167 | (11), subsection (46) (45), or subsection (53) (52). |
3168 | (54)(53) "Wholesale distribution" means distribution of |
3169 | prescription drugs to persons other than a consumer or patient, |
3170 | but does not include: |
3171 | (a) Any of the following activities, which is not a |
3172 | violation of s. 499.005(21) if such activity is conducted in |
3173 | accordance with s. 499.01(2)(g): |
3174 | 1. The purchase or other acquisition by a hospital or |
3175 | other health care entity that is a member of a group purchasing |
3176 | organization of a prescription drug for its own use from the |
3177 | group purchasing organization or from other hospitals or health |
3178 | care entities that are members of that organization. |
3179 | 2. The sale, purchase, or trade of a prescription drug or |
3180 | an offer to sell, purchase, or trade a prescription drug by a |
3181 | charitable organization described in s. 501(c)(3) of the |
3182 | Internal Revenue Code of 1986, as amended and revised, to a |
3183 | nonprofit affiliate of the organization to the extent otherwise |
3184 | permitted by law. |
3185 | 3. The sale, purchase, or trade of a prescription drug or |
3186 | an offer to sell, purchase, or trade a prescription drug among |
3187 | hospitals or other health care entities that are under common |
3188 | control. For purposes of this subparagraph, "common control" |
3189 | means the power to direct or cause the direction of the |
3190 | management and policies of a person or an organization, whether |
3191 | by ownership of stock, by voting rights, by contract, or |
3192 | otherwise. |
3193 | 4. The sale, purchase, trade, or other transfer of a |
3194 | prescription drug from or for any federal, state, or local |
3195 | government agency or any entity eligible to purchase |
3196 | prescription drugs at public health services prices pursuant to |
3197 | Pub. L. No. 102-585, s. 602 to a contract provider or its |
3198 | subcontractor for eligible patients of the agency or entity |
3199 | under the following conditions: |
3200 | a. The agency or entity must obtain written authorization |
3201 | for the sale, purchase, trade, or other transfer of a |
3202 | prescription drug under this subparagraph from the State Surgeon |
3203 | General or his or her designee. |
3204 | b. The contract provider or subcontractor must be |
3205 | authorized by law to administer or dispense prescription drugs. |
3206 | c. In the case of a subcontractor, the agency or entity |
3207 | must be a party to and execute the subcontract. |
3208 | d. A contract provider or subcontractor must maintain |
3209 | separate and apart from other prescription drug inventory any |
3210 | prescription drugs of the agency or entity in its possession. |
3211 | d.e. The contract provider and subcontractor must maintain |
3212 | and produce immediately for inspection all records of movement |
3213 | or transfer of all the prescription drugs belonging to the |
3214 | agency or entity, including, but not limited to, the records of |
3215 | receipt and disposition of prescription drugs. Each contractor |
3216 | and subcontractor dispensing or administering these drugs must |
3217 | maintain and produce records documenting the dispensing or |
3218 | administration. Records that are required to be maintained |
3219 | include, but are not limited to, a perpetual inventory itemizing |
3220 | drugs received and drugs dispensed by prescription number or |
3221 | administered by patient identifier, which must be submitted to |
3222 | the agency or entity quarterly. |
3223 | e.f. The contract provider or subcontractor may administer |
3224 | or dispense the prescription drugs only to the eligible patients |
3225 | of the agency or entity or must return the prescription drugs |
3226 | for or to the agency or entity. The contract provider or |
3227 | subcontractor must require proof from each person seeking to |
3228 | fill a prescription or obtain treatment that the person is an |
3229 | eligible patient of the agency or entity and must, at a minimum, |
3230 | maintain a copy of this proof as part of the records of the |
3231 | contractor or subcontractor required under sub-subparagraph d. |
3232 | e. |
3233 | f.g. In addition to the departmental inspection authority |
3234 | set forth in s. 499.051, the establishment of the contract |
3235 | provider and subcontractor and all records pertaining to |
3236 | prescription drugs subject to this subparagraph shall be subject |
3237 | to inspection by the agency or entity. All records relating to |
3238 | prescription drugs of a manufacturer under this subparagraph |
3239 | shall be subject to audit by the manufacturer of those drugs, |
3240 | without identifying individual patient information. |
3241 | Section 87. Paragraph (i) is added to subsection (3) of |
3242 | section 499.01212, Florida Statutes, to read: |
3243 | 499.01212 Pedigree paper.- |
3244 | (3) EXCEPTIONS.-A pedigree paper is not required for: |
3245 | (i) The wholesale distribution of prescription drugs |
3246 | contained within a medical convenience kit if: |
3247 | 1. The medical convenience kit is assembled in an |
3248 | establishment that is registered as a medical device |
3249 | manufacturer with the United States Food and Drug |
3250 | Administration; |
3251 | 2. The medical convenience kit manufacturer purchased the |
3252 | prescription drug directly from the manufacturer or from a |
3253 | wholesaler that purchased the prescription drug directly from |
3254 | the manufacturer; |
3255 | 3. The medical convenience kit manufacturer complies with |
3256 | federal law for the distribution of the prescription drugs |
3257 | within the kit; and |
3258 | 4. The drugs contained in the medical convenience kit are: |
3259 | a. Intravenous solutions intended for the replenishment of |
3260 | fluids and electrolytes; |
3261 | b. Products intended to maintain the equilibrium of water |
3262 | and minerals in the body; |
3263 | c. Products intended for irrigation or reconstitution; |
3264 | d. Anesthetics; or |
3265 | e. Anticoagulants. |
3266 |
|
3267 | This exemption does not apply to a convenience kit containing |
3268 | any controlled substance that appears in a schedule contained in |
3269 | or subject to chapter 893 or the federal Comprehensive Drug |
3270 | Abuse Prevention and Control Act of 1970. |
3271 | Section 88. Subsection (3) is added to section 626.9541, |
3272 | Florida Statutes, to read: |
3273 | 626.9541 Unfair methods of competition and unfair or |
3274 | deceptive acts or practices defined; alternative rates of |
3275 | payment; wellness programs.- |
3276 | (3) WELLNESS PROGRAMS.-An insurer issuing a group or |
3277 | individual health benefit plan may offer a voluntary wellness or |
3278 | health-improvement program that allows for rewards or |
3279 | incentives, including, but not limited to, merchandise, gift |
3280 | cards, debit cards, premium discounts or rebates, contributions |
3281 | towards a member's health savings account, modifications to |
3282 | copayment, deductible, or coinsurance amounts, or any |
3283 | combination of these incentives, to encourage or reward |
3284 | participation in the program. The health plan member may be |
3285 | required to provide verification, such as a statement from his |
3286 | or her physician, that a medical condition makes it unreasonably |
3287 | difficult or medically inadvisable for the individual to |
3288 | participate in the wellness program. Any reward or incentive |
3289 | established under this subsection is not an insurance benefit |
3290 | and does not violate this section. This subsection does not |
3291 | prohibit an insurer from offering incentives or rewards to |
3292 | members for adherence to wellness or health improvement programs |
3293 | if otherwise allowed by state or federal law. Notwithstanding |
3294 | any provision of this subsection, no insurer, nor its agent, may |
3295 | use any incentive authorized by this subsection for the purpose |
3296 | of redirecting patients from one health care insurance plan to |
3297 | another. |
3298 | Section 89. Subsection (1) of section 627.645, Florida |
3299 | Statutes, is amended to read: |
3300 | 627.645 Denial of health insurance claims restricted.- |
3301 | (1) No claim for payment under a health insurance policy |
3302 | or self-insured program of health benefits for treatment, care, |
3303 | or services in a licensed hospital which is accredited by The |
3304 | Joint Commission on the Accreditation of Hospitals, the American |
3305 | Osteopathic Association, or the Commission on the Accreditation |
3306 | of Rehabilitative Facilities shall be denied because such |
3307 | hospital lacks major surgical facilities and is primarily of a |
3308 | rehabilitative nature, if such rehabilitation is specifically |
3309 | for treatment of physical disability. |
3310 | Section 90. Paragraph (c) of subsection (2) of section |
3311 | 627.668, Florida Statutes, is amended to read: |
3312 | 627.668 Optional coverage for mental and nervous disorders |
3313 | required; exception.- |
3314 | (2) Under group policies or contracts, inpatient hospital |
3315 | benefits, partial hospitalization benefits, and outpatient |
3316 | benefits consisting of durational limits, dollar amounts, |
3317 | deductibles, and coinsurance factors shall not be less favorable |
3318 | than for physical illness generally, except that: |
3319 | (c) Partial hospitalization benefits shall be provided |
3320 | under the direction of a licensed physician. For purposes of |
3321 | this part, the term "partial hospitalization services" is |
3322 | defined as those services offered by a program accredited by The |
3323 | Joint Commission on Accreditation of Hospitals (JCAH) or in |
3324 | compliance with equivalent standards. Alcohol rehabilitation |
3325 | programs accredited by The Joint Commission on Accreditation of |
3326 | Hospitals or approved by the state and licensed drug abuse |
3327 | rehabilitation programs shall also be qualified providers under |
3328 | this section. In any benefit year, if partial hospitalization |
3329 | services or a combination of inpatient and partial |
3330 | hospitalization are utilized, the total benefits paid for all |
3331 | such services shall not exceed the cost of 30 days of inpatient |
3332 | hospitalization for psychiatric services, including physician |
3333 | fees, which prevail in the community in which the partial |
3334 | hospitalization services are rendered. If partial |
3335 | hospitalization services benefits are provided beyond the limits |
3336 | set forth in this paragraph, the durational limits, dollar |
3337 | amounts, and coinsurance factors thereof need not be the same as |
3338 | those applicable to physical illness generally. |
3339 | Section 91. Subsection (3) of section 627.669, Florida |
3340 | Statutes, is amended to read: |
3341 | 627.669 Optional coverage required for substance abuse |
3342 | impaired persons; exception.- |
3343 | (3) The benefits provided under this section shall be |
3344 | applicable only if treatment is provided by, or under the |
3345 | supervision of, or is prescribed by, a licensed physician or |
3346 | licensed psychologist and if services are provided in a program |
3347 | accredited by The Joint Commission on Accreditation of Hospitals |
3348 | or approved by the state. |
3349 | Section 92. Paragraph (a) of subsection (1) of section |
3350 | 627.736, Florida Statutes, is amended to read: |
3351 | 627.736 Required personal injury protection benefits; |
3352 | exclusions; priority; claims.- |
3353 | (1) REQUIRED BENEFITS.-Every insurance policy complying |
3354 | with the security requirements of s. 627.733 shall provide |
3355 | personal injury protection to the named insured, relatives |
3356 | residing in the same household, persons operating the insured |
3357 | motor vehicle, passengers in such motor vehicle, and other |
3358 | persons struck by such motor vehicle and suffering bodily injury |
3359 | while not an occupant of a self-propelled vehicle, subject to |
3360 | the provisions of subsection (2) and paragraph (4)(e), to a |
3361 | limit of $10,000 for loss sustained by any such person as a |
3362 | result of bodily injury, sickness, disease, or death arising out |
3363 | of the ownership, maintenance, or use of a motor vehicle as |
3364 | follows: |
3365 | (a) Medical benefits.-Eighty percent of all reasonable |
3366 | expenses for medically necessary medical, surgical, X-ray, |
3367 | dental, and rehabilitative services, including prosthetic |
3368 | devices, and medically necessary ambulance, hospital, and |
3369 | nursing services. However, the medical benefits shall provide |
3370 | reimbursement only for such services and care that are lawfully |
3371 | provided, supervised, ordered, or prescribed by a physician |
3372 | licensed under chapter 458 or chapter 459, a dentist licensed |
3373 | under chapter 466, or a chiropractic physician licensed under |
3374 | chapter 460 or that are provided by any of the following persons |
3375 | or entities: |
3376 | 1. A hospital or ambulatory surgical center licensed under |
3377 | chapter 395. |
3378 | 2. A person or entity licensed under ss. 401.2101-401.45 |
3379 | that provides emergency transportation and treatment. |
3380 | 3. An entity wholly owned by one or more physicians |
3381 | licensed under chapter 458 or chapter 459, chiropractic |
3382 | physicians licensed under chapter 460, or dentists licensed |
3383 | under chapter 466 or by such practitioner or practitioners and |
3384 | the spouse, parent, child, or sibling of that practitioner or |
3385 | those practitioners. |
3386 | 4. An entity wholly owned, directly or indirectly, by a |
3387 | hospital or hospitals. |
3388 | 5. A health care clinic licensed under ss. 400.990-400.995 |
3389 | that is: |
3390 | a. Accredited by The Joint Commission on Accreditation of |
3391 | Healthcare Organizations, the American Osteopathic Association, |
3392 | the Commission on Accreditation of Rehabilitation Facilities, or |
3393 | the Accreditation Association for Ambulatory Health Care, Inc.; |
3394 | or |
3395 | b. A health care clinic that: |
3396 | (I) Has a medical director licensed under chapter 458, |
3397 | chapter 459, or chapter 460; |
3398 | (II) Has been continuously licensed for more than 3 years |
3399 | or is a publicly traded corporation that issues securities |
3400 | traded on an exchange registered with the United States |
3401 | Securities and Exchange Commission as a national securities |
3402 | exchange; and |
3403 | (III) Provides at least four of the following medical |
3404 | specialties: |
3405 | (A) General medicine. |
3406 | (B) Radiography. |
3407 | (C) Orthopedic medicine. |
3408 | (D) Physical medicine. |
3409 | (E) Physical therapy. |
3410 | (F) Physical rehabilitation. |
3411 | (G) Prescribing or dispensing outpatient prescription |
3412 | medication. |
3413 | (H) Laboratory services. |
3414 |
|
3415 | The Financial Services Commission shall adopt by rule the form |
3416 | that must be used by an insurer and a health care provider |
3417 | specified in subparagraph 3., subparagraph 4., or subparagraph |
3418 | 5. to document that the health care provider meets the criteria |
3419 | of this paragraph, which rule must include a requirement for a |
3420 | sworn statement or affidavit. |
3421 |
|
3422 | Only insurers writing motor vehicle liability insurance in this |
3423 | state may provide the required benefits of this section, and no |
3424 | such insurer shall require the purchase of any other motor |
3425 | vehicle coverage other than the purchase of property damage |
3426 | liability coverage as required by s. 627.7275 as a condition for |
3427 | providing such required benefits. Insurers may not require that |
3428 | property damage liability insurance in an amount greater than |
3429 | $10,000 be purchased in conjunction with personal injury |
3430 | protection. Such insurers shall make benefits and required |
3431 | property damage liability insurance coverage available through |
3432 | normal marketing channels. Any insurer writing motor vehicle |
3433 | liability insurance in this state who fails to comply with such |
3434 | availability requirement as a general business practice shall be |
3435 | deemed to have violated part IX of chapter 626, and such |
3436 | violation shall constitute an unfair method of competition or an |
3437 | unfair or deceptive act or practice involving the business of |
3438 | insurance; and any such insurer committing such violation shall |
3439 | be subject to the penalties afforded in such part, as well as |
3440 | those which may be afforded elsewhere in the insurance code. |
3441 | Section 93. Section 633.081, Florida Statutes, is amended |
3442 | to read: |
3443 | 633.081 Inspection of buildings and equipment; orders; |
3444 | firesafety inspection training requirements; certification; |
3445 | disciplinary action.-The State Fire Marshal and her or his |
3446 | agents shall, at any reasonable hour, when the department has |
3447 | reasonable cause to believe that a violation of this chapter or |
3448 | s. 509.215, or a rule promulgated thereunder, or a minimum |
3449 | firesafety code adopted by a local authority, may exist, inspect |
3450 | any and all buildings and structures which are subject to the |
3451 | requirements of this chapter or s. 509.215 and rules promulgated |
3452 | thereunder. The authority to inspect shall extend to all |
3453 | equipment, vehicles, and chemicals which are located within the |
3454 | premises of any such building or structure. The State Fire |
3455 | Marshal and her or his agents shall inspect nursing homes |
3456 | licensed under part II of chapter 400 only once every calendar |
3457 | year and upon receiving a complaint forming the basis of a |
3458 | reasonable cause to believe that a violation of this chapter or |
3459 | s. 509.215, or a rule promulgated thereunder, or a minimum |
3460 | firesafety code adopted by a local authority may exist and upon |
3461 | identifying such a violation in the course of conducting |
3462 | orientation or training activities within a nursing home. |
3463 | (1) Each county, municipality, and special district that |
3464 | has firesafety enforcement responsibilities shall employ or |
3465 | contract with a firesafety inspector. The firesafety inspector |
3466 | must conduct all firesafety inspections that are required by |
3467 | law. The governing body of a county, municipality, or special |
3468 | district that has firesafety enforcement responsibilities may |
3469 | provide a schedule of fees to pay only the costs of inspections |
3470 | conducted pursuant to this subsection and related administrative |
3471 | expenses. Two or more counties, municipalities, or special |
3472 | districts that have firesafety enforcement responsibilities may |
3473 | jointly employ or contract with a firesafety inspector. |
3474 | (2) Every firesafety inspection conducted pursuant to |
3475 | state or local firesafety requirements shall be by a person |
3476 | certified as having met the inspection training requirements set |
3477 | by the State Fire Marshal. Such person shall: |
3478 | (a) Be a high school graduate or the equivalent as |
3479 | determined by the department; |
3480 | (b) Not have been found guilty of, or having pleaded |
3481 | guilty or nolo contendere to, a felony or a crime punishable by |
3482 | imprisonment of 1 year or more under the law of the United |
3483 | States, or of any state thereof, which involves moral turpitude, |
3484 | without regard to whether a judgment of conviction has been |
3485 | entered by the court having jurisdiction of such cases; |
3486 | (c) Have her or his fingerprints on file with the |
3487 | department or with an agency designated by the department; |
3488 | (d) Have good moral character as determined by the |
3489 | department; |
3490 | (e) Be at least 18 years of age; |
3491 | (f) Have satisfactorily completed the firesafety inspector |
3492 | certification examination as prescribed by the department; and |
3493 | (g)1. Have satisfactorily completed, as determined by the |
3494 | department, a firesafety inspector training program of not less |
3495 | than 200 hours established by the department and administered by |
3496 | agencies and institutions approved by the department for the |
3497 | purpose of providing basic certification training for firesafety |
3498 | inspectors; or |
3499 | 2. Have received in another state training which is |
3500 | determined by the department to be at least equivalent to that |
3501 | required by the department for approved firesafety inspector |
3502 | education and training programs in this state. |
3503 | (3) Each special state firesafety inspection which is |
3504 | required by law and is conducted by or on behalf of an agency of |
3505 | the state must be performed by an individual who has met the |
3506 | provision of subsection (2), except that the duration of the |
3507 | training program shall not exceed 120 hours of specific training |
3508 | for the type of property that such special state firesafety |
3509 | inspectors are assigned to inspect. |
3510 | (4) A firefighter certified pursuant to s. 633.35 may |
3511 | conduct firesafety inspections, under the supervision of a |
3512 | certified firesafety inspector, while on duty as a member of a |
3513 | fire department company conducting inservice firesafety |
3514 | inspections without being certified as a firesafety inspector, |
3515 | if such firefighter has satisfactorily completed an inservice |
3516 | fire department company inspector training program of at least |
3517 | 24 hours' duration as provided by rule of the department. |
3518 | (5) Every firesafety inspector or special state firesafety |
3519 | inspector certificate is valid for a period of 3 years from the |
3520 | date of issuance. Renewal of certification shall be subject to |
3521 | the affected person's completing proper application for renewal |
3522 | and meeting all of the requirements for renewal as established |
3523 | under this chapter or by rule promulgated thereunder, which |
3524 | shall include completion of at least 40 hours during the |
3525 | preceding 3-year period of continuing education as required by |
3526 | the rule of the department or, in lieu thereof, successful |
3527 | passage of an examination as established by the department. |
3528 | (6) The State Fire Marshal may deny, refuse to renew, |
3529 | suspend, or revoke the certificate of a firesafety inspector or |
3530 | special state firesafety inspector if it finds that any of the |
3531 | following grounds exist: |
3532 | (a) Any cause for which issuance of a certificate could |
3533 | have been refused had it then existed and been known to the |
3534 | State Fire Marshal. |
3535 | (b) Violation of this chapter or any rule or order of the |
3536 | State Fire Marshal. |
3537 | (c) Falsification of records relating to the certificate. |
3538 | (d) Having been found guilty of or having pleaded guilty |
3539 | or nolo contendere to a felony, whether or not a judgment of |
3540 | conviction has been entered. |
3541 | (e) Failure to meet any of the renewal requirements. |
3542 | (f) Having been convicted of a crime in any jurisdiction |
3543 | which directly relates to the practice of fire code inspection, |
3544 | plan review, or administration. |
3545 | (g) Making or filing a report or record that the |
3546 | certificateholder knows to be false, or knowingly inducing |
3547 | another to file a false report or record, or knowingly failing |
3548 | to file a report or record required by state or local law, or |
3549 | knowingly impeding or obstructing such filing, or knowingly |
3550 | inducing another person to impede or obstruct such filing. |
3551 | (h) Failing to properly enforce applicable fire codes or |
3552 | permit requirements within this state which the |
3553 | certificateholder knows are applicable by committing willful |
3554 | misconduct, gross negligence, gross misconduct, repeated |
3555 | negligence, or negligence resulting in a significant danger to |
3556 | life or property. |
3557 | (i) Accepting labor, services, or materials at no charge |
3558 | or at a noncompetitive rate from any person who performs work |
3559 | that is under the enforcement authority of the certificateholder |
3560 | and who is not an immediate family member of the |
3561 | certificateholder. For the purpose of this paragraph, the term |
3562 | "immediate family member" means a spouse, child, parent, |
3563 | sibling, grandparent, aunt, uncle, or first cousin of the person |
3564 | or the person's spouse or any person who resides in the primary |
3565 | residence of the certificateholder. |
3566 | (7) The department shall provide by rule for the |
3567 | certification of firesafety inspectors. |
3568 | Section 94. Subsection (12) of section 641.495, Florida |
3569 | Statutes, is amended to read: |
3570 | 641.495 Requirements for issuance and maintenance of |
3571 | certificate.- |
3572 | (12) The provisions of part I of chapter 395 do not apply |
3573 | to a health maintenance organization that, on or before January |
3574 | 1, 1991, provides not more than 10 outpatient holding beds for |
3575 | short-term and hospice-type patients in an ambulatory care |
3576 | facility for its members, provided that such health maintenance |
3577 | organization maintains current accreditation by The Joint |
3578 | Commission on Accreditation of Health Care Organizations, the |
3579 | Accreditation Association for Ambulatory Health Care, or the |
3580 | National Committee for Quality Assurance. |
3581 | Section 95. Subsection (13) of section 651.118, Florida |
3582 | Statutes, is amended to read: |
3583 | 651.118 Agency for Health Care Administration; |
3584 | certificates of need; sheltered beds; community beds.- |
3585 | (13) Residents, as defined in this chapter, are not |
3586 | considered new admissions for the purpose of s. |
3587 | 400.141(1)(n)(o)1.d. |
3588 | Section 96. Subsection (2) of section 766.1015, Florida |
3589 | Statutes, is amended to read: |
3590 | 766.1015 Civil immunity for members of or consultants to |
3591 | certain boards, committees, or other entities.- |
3592 | (2) Such committee, board, group, commission, or other |
3593 | entity must be established in accordance with state law or in |
3594 | accordance with requirements of The Joint Commission on |
3595 | Accreditation of Healthcare Organizations, established and duly |
3596 | constituted by one or more public or licensed private hospitals |
3597 | or behavioral health agencies, or established by a governmental |
3598 | agency. To be protected by this section, the act, decision, |
3599 | omission, or utterance may not be made or done in bad faith or |
3600 | with malicious intent. |
3601 | Section 97. Subsection (4) of section 766.202, Florida |
3602 | Statutes, is amended to read: |
3603 | 766.202 Definitions; ss. 766.201-766.212.-As used in ss. |
3604 | 766.201-766.212, the term: |
3605 | (4) "Health care provider" means any hospital, ambulatory |
3606 | surgical center, or mobile surgical facility as defined and |
3607 | licensed under chapter 395; a birth center licensed under |
3608 | chapter 383; any person licensed under chapter 458, chapter 459, |
3609 | chapter 460, chapter 461, chapter 462, chapter 463, part I of |
3610 | chapter 464, chapter 466, chapter 467, part XIV of chapter 468, |
3611 | or chapter 486; a clinical lab licensed under chapter 483; a |
3612 | health maintenance organization certificated under part I of |
3613 | chapter 641; a blood bank; a plasma center; an industrial |
3614 | clinic; a renal dialysis facility; or a professional association |
3615 | partnership, corporation, joint venture, or other association |
3616 | for professional activity by health care providers. |
3617 | Section 98. This act shall take effect July 1, 2010. |