1 | A bill to be entitled |
2 | An act relating to the reorganization of the Department of |
3 | Health; amending s. 20.43, F.S.; revising the mission and |
4 | responsibilities of the department; providing duties of |
5 | the State Surgeon General with respect to management of |
6 | the department; abolishing responsibility to regulate |
7 | health practitioners effective July 1, 2011; abolishing |
8 | specified divisions of the department effective July 1, |
9 | 2011, unless reviewed and reenacted by the Legislature; |
10 | authorizing the department to establish multicounty |
11 | service areas for county health departments; requiring the |
12 | department to submit a reorganization plan to the |
13 | Legislature by a specified date; prohibiting the |
14 | department from establishing new programs or modifying |
15 | current programs without legislative approval; requiring |
16 | the department to seek approval from the Legislative |
17 | Budget Commission for certain activities; providing that |
18 | the request for approval is subject to certain notice, |
19 | review, and objection procedures; amending s. 381.0011, |
20 | F.S.; revising duties and powers of the department; |
21 | requiring the department to manage emergency preparedness |
22 | and disaster response functions; authorizing the |
23 | department to issue health alerts or advisories under |
24 | certain conditions; revising rulemaking authority of the |
25 | department; amending s. 381.006, F.S.; revising the |
26 | definition of the term "group care facility"; amending s. |
27 | 381.0072, F.S.; revising the definition of the term "food |
28 | service establishment"; authorizing the department to |
29 | advise and consult with other agencies relating to the |
30 | provision of food services; revising entities that are |
31 | exempt from rules relating to standards for food service |
32 | establishment manager certification; amending s. 381.0101, |
33 | F.S.; revising the definition of the term "primary |
34 | environmental health program"; repealing s. 381.001, F.S., |
35 | relating to legislative intent with respect to the state's |
36 | public health system; repealing s. 381.04015, F.S., |
37 | relating to the Women's Health Strategy; repealing s. |
38 | 401.243, F.S., relating to the department's injury |
39 | prevention program; repealing ss. 411.23, 411.231, and |
40 | 411.232, F.S., relating to the Children's Early Investment |
41 | Act; amending s. 381.4018, F.S.; providing definitions; |
42 | revising the list of governmental stakeholders that the |
43 | department is required to work with regarding the state |
44 | strategic plan and in assessing the state's physician |
45 | workforce; creating the Physician Workforce Advisory |
46 | Council; providing for appointments, membership, terms, |
47 | and duties of the council; providing that council members |
48 | are not entitled to receive compensation or reimbursement |
49 | for per diem or travel expenses; providing the duties of |
50 | the council; amending s. 392.51, F.S.; revising |
51 | legislative intent with respect to the delivery of |
52 | tuberculosis control services; amending s. 392.69, F.S.; |
53 | requiring the department to develop a plan to provide |
54 | tuberculosis services; requiring the department to submit |
55 | the plan to the Governor and Legislature; amending ss. |
56 | 411.01 and 411.224, F.S.; conforming cross-references; |
57 | amending s. 456.074, F.S.; requiring the Secretary of |
58 | Business and Professional Regulation to consult with the |
59 | State Surgeon General before issuing an emergency |
60 | suspension order for certain licensed providers; providing |
61 | a deadline for the recommendation; amending ss. 458.3192 |
62 | and 459.0082, F.S.; requiring the department to determine |
63 | by geographic area and specialty the number of physicians |
64 | who plan to relocate outside the state, practice medicine |
65 | in this state, and reduce or modify the scope of their |
66 | practice; authorizing the department to include additional |
67 | information in its report to the Governor and Legislature; |
68 | amending s. 499.003, F.S.; defining the term "medical |
69 | convenience kit" for purposes of pt. I of ch. 499, F.S.; |
70 | conforming cross-references; amending s. 499.01, F.S.; |
71 | creating an exemption from device manufacturer permits for |
72 | certain persons; amending s. 499.01212, F.S.; exempting |
73 | specified prescription drugs from pedigree paper |
74 | requirements under certain circumstances; amending s. |
75 | 499.029, F.S.; renaming the Cancer Drug Donation Program |
76 | as the Prescription Drug Donation Program; revising |
77 | definitions; expanding the drugs and supplies that may be |
78 | donated under the program; expanding the types of |
79 | facilities and practitioners that may participate in the |
80 | program; conforming provisions to changes in terminology; |
81 | amending s. 509.013, F.S.; revising the definitions of the |
82 | terms "public lodging establishment" and "public food |
83 | establishment"; transferring and reassigning certain |
84 | functions and responsibilities, including records, |
85 | personnel, property, and unexpended balances of |
86 | appropriations and other resources, from the Department of |
87 | Health to the Department of Business and Professional |
88 | Regulation by a type two transfer; providing for the |
89 | continued validity of pending judicial or administrative |
90 | actions to which the Department of Health is a party; |
91 | providing for the continued validity of lawful orders |
92 | issued by the Department of Health; transferring rules |
93 | created by the Department of Health to the Department of |
94 | Business and Professional Regulation; providing for the |
95 | continued validity of permits and certifications issued by |
96 | the Department of Health; providing effective dates. |
97 |
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98 | Be It Enacted by the Legislature of the State of Florida: |
99 |
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100 | Section 1. Section 20.43, Florida Statutes, is amended to |
101 | read: |
102 | 20.43 Department of Health.-There is created a Department |
103 | of Health. |
104 | (1)(a) The purpose of the Department of Health is |
105 | responsible for to promote and protect the health of all |
106 | residents and visitors in the state through organized state and |
107 | community efforts, including cooperative agreements with |
108 | counties. The department shall: |
109 | 1.(a) Identifying, diagnosing, investigating, and |
110 | conducting surveillance of communicable diseases in the state |
111 | Prevent to the fullest extent possible, the occurrence and |
112 | progression of communicable and noncommunicable diseases and |
113 | disabilities. |
114 | 2.(b) Maintaining Maintain a constant surveillance of |
115 | disease occurrence and accumulating accumulate health statistics |
116 | necessary to establish disease trends and to design health |
117 | programs. |
118 | 3. Implementing interventions that prevent or limit the |
119 | impact or spread of disease in the state. |
120 | 4.(c) Maintaining and coordinating preparedness for and |
121 | responses to public health emergencies in the state Conduct |
122 | special studies of the causes of diseases and formulate |
123 | preventive strategies. |
124 | 5.(d) Regulating environmental activities that have a |
125 | direct impact on public health in the state Promote the |
126 | maintenance and improvement of the environment as it affects |
127 | public health. |
128 | 6.(e) Administering and providing health and related |
129 | services for targeted populations in the state Promote the |
130 | maintenance and improvement of health in the residents of the |
131 | state. |
132 | 7.(f) Collecting, managing, and analyzing vital statistics |
133 | data in the state Provide leadership, in cooperation with the |
134 | public and private sectors, in establishing statewide and |
135 | community public health delivery systems. |
136 | (g) Provide health care and early intervention services to |
137 | infants, toddlers, children, adolescents, and high-risk |
138 | perinatal patients who are at risk for disabling conditions or |
139 | have chronic illnesses. |
140 | (h) Provide services to abused and neglected children |
141 | through child protection teams and sexual abuse treatment |
142 | programs. |
143 | (i) Develop working associations with all agencies and |
144 | organizations involved and interested in health and health care |
145 | delivery. |
146 | (j) Analyze trends in the evolution of health systems, and |
147 | identify and promote the use of innovative, cost-effective |
148 | health delivery systems. |
149 | (k) Serve as the statewide repository of all aggregate |
150 | data accumulated by state agencies related to health care; |
151 | analyze that data and issue periodic reports and policy |
152 | statements, as appropriate; require that all aggregated data be |
153 | kept in a manner that promotes easy utilization by the public, |
154 | state agencies, and all other interested parties; provide |
155 | technical assistance as required; and work cooperatively with |
156 | the state's higher education programs to promote further study |
157 | and analysis of health care systems and health care outcomes. |
158 | (l) Include in the department's strategic plan developed |
159 | under s. 186.021 an assessment of current health programs, |
160 | systems, and costs; projections of future problems and |
161 | opportunities; and recommended changes that are needed in the |
162 | health care system to improve the public health. |
163 | 8.(m) Regulating Regulate health practitioners, to the |
164 | extent authorized by the Legislature, as necessary for the |
165 | preservation of the health, safety, and welfare of the public. |
166 | This subparagraph expires on July 1, 2011. |
167 | (b) By November 1, 2010, the department shall submit a |
168 | proposal to the President of the Senate, the Speaker of the |
169 | House of Representatives, and the appropriate substantive |
170 | legislative committees for a new department structure based upon |
171 | the responsibilities delegated under paragraph (a). The proposal |
172 | shall include reductions in the number of departmental bureaus |
173 | and divisions and limits on the number of executive positions in |
174 | a manner that enables the department to fulfill the |
175 | responsibilities delegated under paragraph (a). The department |
176 | shall identify existing functions and activities that are |
177 | inconsistent with the responsibilities delegated under paragraph |
178 | (a) and shall provide a job description for each bureau chief |
179 | and division director position proposed for retention. |
180 | (2)(a) The head of the Department of Health is the State |
181 | Surgeon General and State Health Officer. The State Surgeon |
182 | General must be a physician licensed under chapter 458 or |
183 | chapter 459 who has advanced training or extensive experience in |
184 | public health administration. The State Surgeon General is |
185 | appointed by the Governor subject to confirmation by the Senate. |
186 | The State Surgeon General serves at the pleasure of the |
187 | Governor. The State Surgeon General shall manage the department |
188 | as it carries out the responsibilities delegated under paragraph |
189 | (1)(a) serve as the leading voice on wellness and disease |
190 | prevention efforts, including the promotion of healthful |
191 | lifestyles, immunization practices, health literacy, and the |
192 | assessment and promotion of the physician and health care |
193 | workforce in order to meet the health care needs of the state. |
194 | The State Surgeon General shall focus on advocating healthy |
195 | lifestyles, developing public health policy, and building |
196 | collaborative partnerships with schools, businesses, health care |
197 | practitioners, community-based organizations, and public and |
198 | private institutions in order to promote health literacy and |
199 | optimum quality of life for all Floridians. |
200 | (b) The Officer of Women's Health Strategy is established |
201 | within the Department of Health and shall report directly to the |
202 | State Surgeon General. |
203 | (3) The following divisions of the Department of Health |
204 | are established: |
205 | (a) Division of Administration. This paragraph expires |
206 | July 1, 2011, unless reviewed and reenacted by the Legislature |
207 | before that date. |
208 | (b) Division of Environmental Health. This paragraph |
209 | expires July 1, 2011, unless reviewed and reenacted by the |
210 | Legislature before that date. |
211 | (c) Division of Disease Control. This paragraph expires |
212 | July 1, 2011, unless reviewed and reenacted by the Legislature |
213 | before that date. |
214 | (d) Division of Family Health Services. This paragraph |
215 | expires July 1, 2011, unless reviewed and reenacted by the |
216 | Legislature before that date. |
217 | (e) Division of Children's Medical Services Network. This |
218 | paragraph expires July 1, 2011, unless reviewed and reenacted by |
219 | the Legislature before that date. |
220 | (f) Division of Emergency Medical Operations. This |
221 | paragraph expires July 1, 2011, unless reviewed and reenacted by |
222 | the Legislature before that date. |
223 | (g) Division of Medical Quality Assurance, which is |
224 | responsible for the following boards and professions established |
225 | within the division: |
226 | 1. The Board of Acupuncture, created under chapter 457. |
227 | 2. The Board of Medicine, created under chapter 458. |
228 | 3. The Board of Osteopathic Medicine, created under |
229 | chapter 459. |
230 | 4. The Board of Chiropractic Medicine, created under |
231 | chapter 460. |
232 | 5. The Board of Podiatric Medicine, created under chapter |
233 | 461. |
234 | 6. Naturopathy, as provided under chapter 462. |
235 | 7. The Board of Optometry, created under chapter 463. |
236 | 8. The Board of Nursing, created under part I of chapter |
237 | 464. |
238 | 9. Nursing assistants, as provided under part II of |
239 | chapter 464. |
240 | 10. The Board of Pharmacy, created under chapter 465. |
241 | 11. The Board of Dentistry, created under chapter 466. |
242 | 12. Midwifery, as provided under chapter 467. |
243 | 13. The Board of Speech-Language Pathology and Audiology, |
244 | created under part I of chapter 468. |
245 | 14. The Board of Nursing Home Administrators, created |
246 | under part II of chapter 468. |
247 | 15. The Board of Occupational Therapy, created under part |
248 | III of chapter 468. |
249 | 16. Respiratory therapy, as provided under part V of |
250 | chapter 468. |
251 | 17. Dietetics and nutrition practice, as provided under |
252 | part X of chapter 468. |
253 | 18. The Board of Athletic Training, created under part |
254 | XIII of chapter 468. |
255 | 19. The Board of Orthotists and Prosthetists, created |
256 | under part XIV of chapter 468. |
257 | 20. Electrolysis, as provided under chapter 478. |
258 | 21. The Board of Massage Therapy, created under chapter |
259 | 480. |
260 | 22. The Board of Clinical Laboratory Personnel, created |
261 | under part III of chapter 483. |
262 | 23. Medical physicists, as provided under part IV of |
263 | chapter 483. |
264 | 24. The Board of Opticianry, created under part I of |
265 | chapter 484. |
266 | 25. The Board of Hearing Aid Specialists, created under |
267 | part II of chapter 484. |
268 | 26. The Board of Physical Therapy Practice, created under |
269 | chapter 486. |
270 | 27. The Board of Psychology, created under chapter 490. |
271 | 28. School psychologists, as provided under chapter 490. |
272 | 29. The Board of Clinical Social Work, Marriage and Family |
273 | Therapy, and Mental Health Counseling, created under chapter |
274 | 491. |
275 |
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276 | This paragraph expires July 1, 2011. |
277 | (h) Division of Children's Medical Services Prevention and |
278 | Intervention. This paragraph expires July 1, 2011, unless |
279 | reviewed and reenacted by the Legislature before that date. |
280 | (i) Division of Information Technology. This paragraph |
281 | expires July 1, 2011, unless reviewed and reenacted by the |
282 | Legislature before that date. |
283 | (j) Division of Health Access and Tobacco. This paragraph |
284 | expires July 1, 2011, unless reviewed and reenacted by the |
285 | Legislature before that date. |
286 | (k) Division of Disability Determinations. This paragraph |
287 | expires July 1, 2011, unless reviewed and reenacted by the |
288 | Legislature before that date. |
289 | (4)(a) The members of each board within the department |
290 | shall be appointed by the Governor, subject to confirmation by |
291 | the Senate. Consumer members on the board shall be appointed |
292 | pursuant to paragraph (b). Members shall be appointed for 4-year |
293 | terms, and such terms shall expire on October 31. However, a |
294 | term of less than 4 years may be used to ensure that: |
295 | 1. No more than two members' terms expire during the same |
296 | calendar year for boards consisting of seven or eight members. |
297 | 2. No more than 3 members' terms expire during the same |
298 | calendar year for boards consisting of 9 to 12 members. |
299 | 3. No more than 5 members' terms expire during the same |
300 | calendar year for boards consisting of 13 or more members. |
301 |
|
302 | A member whose term has expired shall continue to serve on the |
303 | board until such time as a replacement is appointed. A vacancy |
304 | on the board shall be filled for the unexpired portion of the |
305 | term in the same manner as the original appointment. No member |
306 | may serve for more than the remaining portion of a previous |
307 | member's unexpired term, plus two consecutive 4-year terms of |
308 | the member's own appointment thereafter. |
309 | (b) Each board with five or more members shall have at |
310 | least two consumer members who are not, and have never been, |
311 | members or practitioners of the profession regulated by such |
312 | board or of any closely related profession. Each board with |
313 | fewer than five members shall have at least one consumer member |
314 | who is not, and has never been, a member or practitioner of the |
315 | profession regulated by such board or of any closely related |
316 | profession. |
317 | (c) Notwithstanding any other provision of law, the |
318 | department is authorized to establish uniform application forms |
319 | and certificates of licensure for use by the boards within the |
320 | department. Nothing in this paragraph authorizes the department |
321 | to vary any substantive requirements, duties, or eligibilities |
322 | for licensure or certification as provided by law. |
323 | (5) The department shall plan and administer authorized |
324 | its public health programs through its county health departments |
325 | and may, for administrative purposes and efficient service |
326 | delivery, establish multicounty up to 15 service areas to carry |
327 | out such duties as may be prescribed by the State Surgeon |
328 | General. The boundaries of the service areas shall be the same |
329 | as, or combinations of, the service districts of the Department |
330 | of Children and Family Services established in s. 20.19 and, to |
331 | the extent practicable, shall take into consideration the |
332 | boundaries of the jobs and education regional boards. |
333 | (6) The State Surgeon General may and division directors |
334 | are authorized to appoint ad hoc advisory committees as |
335 | necessary to address issues relating to the responsibilities |
336 | delegated to the department under paragraph (1)(a). The issue or |
337 | problem that the ad hoc committee shall address, and the |
338 | timeframe within which the committee is to complete its work, |
339 | shall be specified at the time the committee is appointed. Ad |
340 | hoc advisory committees shall include representatives of groups |
341 | or entities affected by the issue or problem that the committee |
342 | is asked to examine. Members of ad hoc advisory committees shall |
343 | receive no compensation, but may, within existing departmental |
344 | resources, receive reimbursement for travel expenses as provided |
345 | in s. 112.061. |
346 | (7) To protect and improve the public health, the |
347 | department may use state or federal funds to: |
348 | (a) Provide incentives, including, but not limited to, the |
349 | promotional items listed in paragraph (b), food and including |
350 | food coupons, and payment for travel expenses, for encouraging |
351 | healthy lifestyle and disease prevention behaviors and patient |
352 | compliance with medical treatment, such as tuberculosis therapy |
353 | and smoking cessation programs. Such incentives shall be |
354 | intended to cause individuals to take action to improve their |
355 | health. Any incentive for food, food coupons, or travel expenses |
356 | may not exceed the limitations in s. 112.061. |
357 | (b) Plan and conduct health education campaigns for the |
358 | purpose of protecting or improving public health. The department |
359 | may purchase promotional items, such as, but not limited to, t- |
360 | shirts, hats, sports items such as water bottles and sweat |
361 | bands, calendars, nutritional charts, baby bibs, growth charts, |
362 | and other items printed with health promotion messages, and |
363 | advertising, such as space on billboards or in publications or |
364 | radio or television time, for health information and promotional |
365 | messages that recognize that the following behaviors, among |
366 | others, are detrimental to public health: unprotected sexual |
367 | intercourse, other than with one's spouse; cigarette and cigar |
368 | smoking, use of smokeless tobacco products, and exposure to |
369 | environmental tobacco smoke; alcohol consumption or other |
370 | substance abuse during pregnancy; alcohol abuse or other |
371 | substance abuse; lack of exercise and poor diet and nutrition |
372 | habits; and failure to recognize and address a genetic tendency |
373 | to suffer from sickle-cell anemia, diabetes, high blood |
374 | pressure, cardiovascular disease, or cancer. For purposes of |
375 | activities under this paragraph, the Department of Health may |
376 | establish requirements for local matching funds or in-kind |
377 | contributions to create and distribute advertisements, in either |
378 | print or electronic format, which are concerned with each of the |
379 | targeted behaviors, establish an independent evaluation and |
380 | feedback system for the public health communication campaign, |
381 | and monitor and evaluate the efforts to determine which of the |
382 | techniques and methodologies are most effective. |
383 | (c) Plan and conduct promotional campaigns to recruit |
384 | health professionals to be employed by the department or to |
385 | recruit participants in departmental programs for health |
386 | practitioners, such as scholarship, loan repayment, or volunteer |
387 | programs. To this effect the department may purchase promotional |
388 | items and advertising. |
389 | (8) The department may hold copyrights, trademarks, and |
390 | service marks and enforce its rights with respect thereto, |
391 | except such authority does not extend to any public records |
392 | relating to the department's responsibilities for health care |
393 | practitioners regulated under part II of chapter 455. |
394 | (7)(9) There is established within the Department of |
395 | Health the Office of Minority Health. |
396 | (8)(a) Beginning in fiscal year 2010-2011, the department |
397 | shall initiate or commence new programs, including any new |
398 | federally funded or grant-supported initiative, or make changes |
399 | in current programs only when the Legislature expressly |
400 | authorizes the department to do so. |
401 | (b) Beginning in fiscal year 2010-2011, prior to applying |
402 | for any continuation of federal or private grants, the |
403 | department shall request the express approval of the Legislative |
404 | Budget Commission. The request for approval shall provide |
405 | detailed information about the purpose of the grant, the prior |
406 | use of the grant, the reason for continuation, the intended use |
407 | of the continuation funds, and the number of full-time permanent |
408 | or temporary employees that participate in administering the |
409 | program funded by the grant. This paragraph is subject to the |
410 | notice, review, and objection procedures set forth in s. |
411 | 216.177. |
412 | Section 2. Section 381.0011, Florida Statutes, is amended |
413 | to read: |
414 | 381.0011 Duties and powers of the Department of Health.-It |
415 | is the duty of the Department of Health to: |
416 | (1) Assess the public health status and needs of the state |
417 | pursuant to the responsibilities delegated to the department |
418 | under s. 20.43 through statewide data collection and other |
419 | appropriate means, with special attention to future needs that |
420 | may result from population growth, technological advancements, |
421 | new societal priorities, or other changes. |
422 | (2) Manage and coordinate emergency preparedness and |
423 | disaster response functions to: investigate and control the |
424 | spread of disease; coordinate the availability and staffing of |
425 | special needs shelters; support patient evacuation; ensure the |
426 | safety of food and drugs; provide critical incident stress |
427 | debriefing; and provide surveillance and control of |
428 | radiological, chemical, biological, and other environmental |
429 | hazards Formulate general policies affecting the public health |
430 | of the state. |
431 | (3) Include in the department's strategic plan developed |
432 | under s. 186.021 a summary of all aspects of the public health |
433 | related to the responsibilities delegated to the department |
434 | under s. 20.43(1) mission and health status objectives to direct |
435 | the use of public health resources with an emphasis on |
436 | prevention. |
437 | (4) Administer and enforce laws and rules relating to |
438 | sanitation, control of communicable diseases, and illnesses and |
439 | hazards to health among humans and from animals to humans, and |
440 | the general health of the people of the state. |
441 | (5) Cooperate with and accept assistance from federal, |
442 | state, and local officials for the prevention and suppression of |
443 | communicable and other diseases, illnesses, injuries, and |
444 | hazards to human health and cooperate with the Federal |
445 | Government in enforcing public health laws and regulations. |
446 | (6) Declare, enforce, modify, and abolish quarantine of |
447 | persons, animals, and premises as the circumstances indicate for |
448 | controlling communicable diseases or providing protection from |
449 | unsafe conditions that pose a threat to public health, except as |
450 | provided in ss. 384.28 and 392.545-392.60. |
451 | (a) The department shall adopt rules to specify the |
452 | conditions and procedures for imposing and releasing a |
453 | quarantine. The rules must include provisions related to: |
454 | 1. The closure of premises. |
455 | 2. The movement of persons or animals exposed to or |
456 | infected with a communicable disease. |
457 | 3. The tests or treatment, including vaccination, for |
458 | communicable disease required prior to employment or admission |
459 | to the premises or to comply with a quarantine. |
460 | 4. Testing or destruction of animals with or suspected of |
461 | having a disease transmissible to humans. |
462 | 5. Access by the department to quarantined premises. |
463 | 6. The disinfection of quarantined animals, persons, or |
464 | premises. |
465 | 7. Methods of quarantine. |
466 | (b) Any health regulation that restricts travel or trade |
467 | within the state may not be adopted or enforced in this state |
468 | except by authority of the department. |
469 | (7) Identify, diagnose, investigate, and conduct |
470 | surveillance of communicable diseases in the state and promote |
471 | and implement interventions that prevent or limit the impact and |
472 | spread of disease in the state Provide for a thorough |
473 | investigation and study of the incidence, causes, modes of |
474 | propagation and transmission, and means of prevention, control, |
475 | and cure of diseases, illnesses, and hazards to human health. |
476 | (8) Issue, as necessary and in its discretion, health |
477 | alerts or advisories Provide for the dissemination of |
478 | information to the public relative to the prevention, control, |
479 | and cure of diseases, illnesses, and hazards to human health. |
480 | The department shall conduct a workshop before issuing any |
481 | health alert or advisory relating to food-borne illness or |
482 | communicable disease in public lodging or food service |
483 | establishments in order to inform persons, trade associations, |
484 | and businesses of the risk to public health and to seek the |
485 | input of affected persons, trade associations, and businesses on |
486 | the best methods of informing and protecting the public. The |
487 | department shall conduct a workshop before issuing any such |
488 | alert or advisory, except in an emergency, in which case the |
489 | workshop must be held within 14 days after the issuance of the |
490 | emergency alert or advisory. |
491 | (9) Act as registrar of vital statistics. |
492 | (10) Cooperate with and assist federal health officials in |
493 | enforcing public health laws and regulations. |
494 | (11) Cooperate with other departments, local officials, |
495 | and private boards and organizations for the improvement and |
496 | preservation of the public health. |
497 | (12) Maintain a statewide injury-prevention program. |
498 | (10)(13) Adopt rules pursuant to ss. 120.536(1) and 120.54 |
499 | to implement the provisions of law conferring duties upon it. |
500 | This subsection does not authorize the department to require a |
501 | permit or license or to inspect a building or facility, unless |
502 | such requirement is specifically provided by law. |
503 | (11)(14) Perform any other duties expressly assigned to |
504 | the department prescribed by law. |
505 | Section 3. Subsection (16) of section 381.006, Florida |
506 | Statutes, is amended to read: |
507 | 381.006 Environmental health.-The department shall conduct |
508 | an environmental health program as part of fulfilling the |
509 | state's public health mission. The purpose of this program is to |
510 | detect and prevent disease caused by natural and manmade factors |
511 | in the environment. The environmental health program shall |
512 | include, but not be limited to: |
513 | (16) A group-care-facilities function. As used in this |
514 | subsection, the term, where a "group care facility" means any |
515 | public or private school, assisted living facility, adult |
516 | family-care home, adult day care center, short-term residential |
517 | treatment center, residential treatment facility, home for |
518 | special services, transitional living facility, crisis |
519 | stabilization unit, hospice, prescribed pediatric extended care |
520 | center, intermediate care facility for persons with |
521 | developmental disabilities, or boarding school housing, building |
522 | or buildings, section of a building, or distinct part of a |
523 | building or other place, whether operated for profit or not, |
524 | which undertakes, through its ownership or management, to |
525 | provide one or more personal services, care, protection, and |
526 | supervision to persons who require such services and who are not |
527 | related to the owner or administrator. The department may adopt |
528 | rules necessary to protect the health and safety of residents, |
529 | staff, and patrons of group care facilities. Rules related to |
530 | public and private schools shall be developed by, such as child |
531 | care facilities, family day care homes, assisted living |
532 | facilities, adult day care centers, adult family care homes, |
533 | hospices, residential treatment facilities, crisis stabilization |
534 | units, pediatric extended care centers, intermediate care |
535 | facilities for the developmentally disabled, group care homes, |
536 | and, jointly with the Department of Education in consultation |
537 | with the department, private and public schools. These Rules |
538 | adopted under this subsection may include definitions of terms; |
539 | provisions relating to operation and maintenance of facilities, |
540 | buildings, grounds, equipment, furnishings, and occupant-space |
541 | requirements; lighting; heating, cooling, and ventilation; food |
542 | service; water supply and plumbing; sewage; sanitary facilities; |
543 | insect and rodent control; garbage; safety; personnel health, |
544 | hygiene, and work practices; and other matters the department |
545 | finds are appropriate or necessary to protect the safety and |
546 | health of the residents, staff, students, faculty, or patrons. |
547 | The department may not adopt rules that conflict with rules |
548 | adopted by the licensing or certifying agency. The department |
549 | may enter and inspect at reasonable hours to determine |
550 | compliance with applicable statutes or rules. In addition to any |
551 | sanctions that the department may impose for violations of rules |
552 | adopted under this section, the department shall also report |
553 | such violations to any agency responsible for licensing or |
554 | certifying the group care facility. The licensing or certifying |
555 | agency may also impose any sanction based solely on the findings |
556 | of the department. |
557 |
|
558 | The department may adopt rules to carry out the provisions of |
559 | this section. |
560 | Section 4. Subsections (1), (2), (3), and (6) of section |
561 | 381.0072, Florida Statutes, are amended to read: |
562 | 381.0072 Food service protection.-It shall be the duty of |
563 | the Department of Health to adopt and enforce sanitation rules |
564 | consistent with law to ensure the protection of the public from |
565 | food-borne illness. These rules shall provide the standards and |
566 | requirements for the storage, preparation, serving, or display |
567 | of food in food service establishments as defined in this |
568 | section and which are not permitted or licensed under chapter |
569 | 500 or chapter 509. |
570 | (1) DEFINITIONS.-As used in this section, the term: |
571 | (a) "Department" means the Department of Health or its |
572 | representative county health department. |
573 | (b) "Food service establishment" means detention |
574 | facilities, public or private schools, migrant labor camps, |
575 | assisted living facilities, adult family-care homes, adult day |
576 | care centers, short-term residential treatment centers, |
577 | residential treatment facilities, homes for special services, |
578 | transitional living facilities, crisis stabilization units, |
579 | hospices, prescribed pediatric extended care centers, |
580 | intermediate care facilities for persons with developmental |
581 | disabilities, boarding schools, civic or fraternal |
582 | organizations, bars and lounges, vending machines that dispense |
583 | potentially hazardous foods at facilities expressly named in |
584 | this paragraph, and facilities used as temporary food events or |
585 | mobile food units at any facility expressly named any facility, |
586 | as described in this paragraph, where food is prepared and |
587 | intended for individual portion service, including and includes |
588 | the site at which individual portions are provided,. The term |
589 | includes any such facility regardless of |
590 | on or off the premises and regardless of whether there is a |
591 | charge for the food. The term includes detention facilities, |
592 | child care facilities, schools, institutions, civic or fraternal |
593 | organizations, bars and lounges and facilities used at temporary |
594 | food events, mobile food units, and vending machines at any |
595 | facility regulated under this section. The term does not include |
596 | any entity not expressly named in this paragraph private homes |
597 | where food is prepared or served for individual family |
598 | consumption; nor does the term include churches, synagogues, or |
599 | other not-for-profit religious organizations as long as these |
600 | organizations serve only their members and guests and do not |
601 | advertise food or drink for public consumption, or any facility |
602 | or establishment permitted or licensed under chapter 500 or |
603 | chapter 509; nor does the term include any theater, if the |
604 | primary use is as a theater and if patron service is limited to |
605 | food items customarily served to the admittees of theaters; nor |
606 | does the term include a research and development test kitchen |
607 | limited to the use of employees and which is not open to the |
608 | general public. |
609 | (c) "Operator" means the owner, operator, keeper, |
610 | proprietor, lessee, manager, assistant manager, agent, or |
611 | employee of a food service establishment. |
612 | (2) DUTIES.- |
613 | (a) The department may advise and consult with the Agency |
614 | for Health Care Administration, the Department of Business and |
615 | Professional Regulation, the Department of Agriculture and |
616 | Consumer Services, and the Department of Children and Family |
617 | Services concerning procedures related to the storage, |
618 | preparation, serving, or display of food at any building, |
619 | structure, or facility not expressly included in this section |
620 | that is inspected, licensed, or regulated by those agencies. |
621 | (b)(a) The department shall adopt rules, including |
622 | definitions of terms which are consistent with law prescribing |
623 | minimum sanitation standards and manager certification |
624 | requirements as prescribed in s. 509.039, and which shall be |
625 | enforced in food service establishments as defined in this |
626 | section. The sanitation standards must address the construction, |
627 | operation, and maintenance of the establishment; lighting, |
628 | ventilation, laundry rooms, lockers, use and storage of toxic |
629 | materials and cleaning compounds, and first-aid supplies; plan |
630 | review; design, construction, installation, location, |
631 | maintenance, sanitation, and storage of food equipment and |
632 | utensils; employee training, health, hygiene, and work |
633 | practices; food supplies, preparation, storage, transportation, |
634 | and service, including access to the areas where food is stored |
635 | or prepared; and sanitary facilities and controls, including |
636 | water supply and sewage disposal; plumbing and toilet |
637 | facilities; garbage and refuse collection, storage, and |
638 | disposal; and vermin control. Public and private schools, if the |
639 | food service is operated by school employees,; hospitals |
640 | licensed under chapter 395; nursing homes licensed under part II |
641 | of chapter 400; child care facilities as defined in s. 402.301; |
642 | residential facilities colocated with a nursing home or |
643 | hospital, if all food is prepared in a central kitchen that |
644 | complies with nursing or hospital regulations; and bars and |
645 | lounges, civic organizations, and any other facility that is not |
646 | regulated under this section as defined by department rule, are |
647 | exempt from the rules developed for manager certification. The |
648 | department shall administer a comprehensive inspection, |
649 | monitoring, and sampling program to ensure such standards are |
650 | maintained. With respect to food service establishments |
651 | permitted or licensed under chapter 500 or chapter 509, the |
652 | department shall assist the Division of Hotels and Restaurants |
653 | of the Department of Business and Professional Regulation and |
654 | the Department of Agriculture and Consumer Services with |
655 | rulemaking by providing technical information. |
656 | (c)(b) The department shall carry out all provisions of |
657 | this chapter and all other applicable laws and rules relating to |
658 | the inspection or regulation of food service establishments as |
659 | defined in this section, for the purpose of safeguarding the |
660 | public's health, safety, and welfare. |
661 | (d)(c) The department shall inspect each food service |
662 | establishment as often as necessary to ensure compliance with |
663 | applicable laws and rules. The department shall have the right |
664 | of entry and access to these food service establishments at any |
665 | reasonable time. In inspecting food service establishments as |
666 | provided under this section, the department shall provide each |
667 | inspected establishment with the food recovery brochure |
668 | developed under s. 570.0725. |
669 | (e)(d) The department or other appropriate regulatory |
670 | entity may inspect theaters exempted in subsection (1) to ensure |
671 | compliance with applicable laws and rules pertaining to minimum |
672 | sanitation standards. A fee for inspection shall be prescribed |
673 | by rule, but the aggregate amount charged per year per theater |
674 | establishment shall not exceed $300, regardless of the entity |
675 | providing the inspection. |
676 | (3) LICENSES REQUIRED.- |
677 | (a) Licenses; annual renewals.-Each food service |
678 | establishment regulated under this section shall obtain a |
679 | license from the department annually. Food service establishment |
680 | licenses shall expire annually and are not transferable from one |
681 | place or individual to another. However, those facilities |
682 | licensed by the department's Office of Licensure and |
683 | Certification, the Child Care Services Program Office, or the |
684 | Agency for Persons with Disabilities are exempt from this |
685 | subsection. It shall be a misdemeanor of the second degree, |
686 | punishable as provided in s. 381.0061, s. 775.082, or s. |
687 | 775.083, for such an establishment to operate without this |
688 | license. The department may refuse a license, or a renewal |
689 | thereof, to any establishment that is not constructed or |
690 | maintained in accordance with law and with the rules of the |
691 | department. Annual application for renewal is not required. |
692 | (b) Application for license.-Each person who plans to open |
693 | a food service establishment regulated under this section and |
694 | not regulated under chapter 500 or chapter 509 shall apply for |
695 | and receive a license prior to the commencement of operation. |
696 | (6) IMMINENT DANGERS; STOP-SALE ORDERS.- |
697 | (a) In the course of epidemiological investigations or for |
698 | those establishments regulated by the department under this |
699 | chapter, the department, to protect the public from food that is |
700 | unwholesome or otherwise unfit for human consumption, may |
701 | examine, sample, seize, and stop the sale or use of food to |
702 | determine its condition. The department may stop the sale and |
703 | supervise the proper destruction of food when the State Health |
704 | Officer or his or her designee determines that such food |
705 | represents a threat to the public health. |
706 | (b) The department may determine that a food service |
707 | establishment regulated under this section is an imminent danger |
708 | to the public health and require its immediate closure when such |
709 | establishment fails to comply with applicable sanitary and |
710 | safety standards and, because of such failure, presents an |
711 | imminent threat to the public's health, safety, and welfare. The |
712 | department may accept inspection results from state and local |
713 | building and firesafety officials and other regulatory agencies |
714 | as justification for such actions. Any facility so deemed and |
715 | closed shall remain closed until allowed by the department or by |
716 | judicial order to reopen. |
717 | Section 5. Paragraph (g) of subsection (2) of section |
718 | 381.0101, Florida Statutes, is amended to read: |
719 | (2) DEFINITIONS.-As used in this section: |
720 | (g) "Primary environmental health program" means those |
721 | programs determined by the department is expressly authorized by |
722 | law to administer to be essential for providing basic |
723 | environmental and sanitary protection to the public. At a |
724 | minimum, These programs shall include food protection program |
725 | work at food service establishments as defined in s. 381.0072 |
726 | and onsite sewage treatment and disposal system evaluations. |
727 | Section 6. Sections 381.001, 381.04015, 401.243, 411.23, |
728 | 411.231, and 411.232, Florida Statutes, are repealed. |
729 | Section 7. Section 381.4018, Florida Statutes, is amended |
730 | to read: |
731 | 381.4018 Physician workforce assessment and development.- |
732 | (1) DEFINITIONS.-As used in this section, the term: |
733 | (a) "Consortium" or "consortia" means a combination of |
734 | statutory teaching hospitals, statutory rural hospitals, other |
735 | hospitals, accredited medical schools, clinics operated by the |
736 | department, clinics operated by the Department of Veterans' |
737 | Affairs, area health education centers, community health |
738 | centers, federally qualified health centers, prison clinics, |
739 | local community clinics, or other programs. At least one member |
740 | of the consortium shall be a sponsoring institution accredited |
741 | or currently seeking accreditation by the Accreditation Council |
742 | for Graduate Medical Education or the American Osteopathic |
743 | Association. |
744 | (b) "Council" means the Physician Workforce Advisory |
745 | Council. |
746 | (c) "Department" means the Department of Health. |
747 | (d) "Graduate medical education program" means a program |
748 | accredited by the Accreditation Council for Graduate Medical |
749 | Education or the American Osteopathic Association. |
750 | (e) "Primary care specialty" means emergency medicine, |
751 | family practice, internal medicine, pediatrics, psychiatry, |
752 | obstetrics and gynecology, or combined internal medicine and |
753 | other primary care specialties as determined by the council or |
754 | the department. |
755 | (2)(1) LEGISLATIVE INTENT.- The Legislature recognizes |
756 | that physician workforce planning is an essential component of |
757 | ensuring that there is an adequate and appropriate supply of |
758 | well-trained physicians to meet this state's future health care |
759 | service needs as the general population and elderly population |
760 | of the state increase. The Legislature finds that items to |
761 | consider relative to assessing the physician workforce may |
762 | include physician practice status; specialty mix; geographic |
763 | distribution; demographic information, including, but not |
764 | limited to, age, gender, race, and cultural considerations; and |
765 | needs of current or projected medically underserved areas in the |
766 | state. Long-term strategic planning is essential as the period |
767 | from the time a medical student enters medical school to |
768 | completion of graduate medical education may range from 7 to 10 |
769 | years or longer. The Legislature recognizes that strategies to |
770 | provide for a well-trained supply of physicians must include |
771 | ensuring the availability and capacity of quality graduate |
772 | medical schools and graduate medical education programs in this |
773 | state, as well as using new or existing state and federal |
774 | programs providing incentives for physicians to practice in |
775 | needed specialties and in underserved areas in a manner that |
776 | addresses projected needs for physician manpower. |
777 | (3)(2) PURPOSE.-The Department of Health shall serve as a |
778 | coordinating and strategic planning body to actively assess the |
779 | state's current and future physician workforce needs and work |
780 | with multiple stakeholders to develop strategies and |
781 | alternatives to address current and projected physician |
782 | workforce needs. |
783 | (4)(3) GENERAL FUNCTIONS.-The department shall maximize |
784 | the use of existing programs under the jurisdiction of the |
785 | department and other state agencies and coordinate governmental |
786 | and nongovernmental stakeholders and resources in order to |
787 | develop a state strategic plan and assess the implementation of |
788 | such strategic plan. In developing the state strategic plan, the |
789 | department shall: |
790 | (a) Monitor, evaluate, and report on the supply and |
791 | distribution of physicians licensed under chapter 458 or chapter |
792 | 459. The department shall maintain a database to serve as a |
793 | statewide source of data concerning the physician workforce. |
794 | (b) Develop a model and quantify, on an ongoing basis, the |
795 | adequacy of the state's current and future physician workforce |
796 | as reliable data becomes available. Such model must take into |
797 | account demographics, physician practice status, place of |
798 | education and training, generational changes, population growth, |
799 | economic indicators, and issues concerning the "pipeline" into |
800 | medical education. |
801 | (c) Develop and recommend strategies to determine whether |
802 | the number of qualified medical school applicants who might |
803 | become competent, practicing physicians in this state will be |
804 | sufficient to meet the capacity of the state's medical schools. |
805 | If appropriate, the department shall, working with |
806 | representatives of appropriate governmental and nongovernmental |
807 | entities, develop strategies and recommendations and identify |
808 | best practice programs that introduce health care as a |
809 | profession and strengthen skills needed for medical school |
810 | admission for elementary, middle, and high school students, and |
811 | improve premedical education at the precollege and college level |
812 | in order to increase this state's potential pool of medical |
813 | students. |
814 | (d) Develop strategies to ensure that the number of |
815 | graduates from the state's public and private allopathic and |
816 | osteopathic medical schools are adequate to meet physician |
817 | workforce needs, based on the analysis of the physician |
818 | workforce data, so as to provide a high-quality medical |
819 | education to students in a manner that recognizes the uniqueness |
820 | of each new and existing medical school in this state. |
821 | (e) Pursue strategies and policies to create, expand, and |
822 | maintain graduate medical education positions in the state based |
823 | on the analysis of the physician workforce data. Such strategies |
824 | and policies must take into account the effect of federal |
825 | funding limitations on the expansion and creation of positions |
826 | in graduate medical education. The department shall develop |
827 | options to address such federal funding limitations. The |
828 | department shall consider options to provide direct state |
829 | funding for graduate medical education positions in a manner |
830 | that addresses requirements and needs relative to accreditation |
831 | of graduate medical education programs. The department shall |
832 | consider funding residency positions as a means of addressing |
833 | needed physician specialty areas, rural areas having a shortage |
834 | of physicians, and areas of ongoing critical need, and as a |
835 | means of addressing the state's physician workforce needs based |
836 | on an ongoing analysis of physician workforce data. |
837 | (f) Develop strategies to maximize federal and state |
838 | programs that provide for the use of incentives to attract |
839 | physicians to this state or retain physicians within the state. |
840 | Such strategies should explore and maximize federal-state |
841 | partnerships that provide incentives for physicians to practice |
842 | in federally designated shortage areas. Strategies shall also |
843 | consider the use of state programs, such as the Florida Health |
844 | Service Corps established pursuant to s. 381.0302 and the |
845 | Medical Education Reimbursement and Loan Repayment Program |
846 | pursuant to s. 1009.65, which provide for education loan |
847 | repayment or loan forgiveness and provide monetary incentives |
848 | for physicians to relocate to underserved areas of the state. |
849 | (g) Coordinate and enhance activities relative to |
850 | physician workforce needs, undergraduate medical education, and |
851 | graduate medical education provided by the Division of Medical |
852 | Quality Assurance, the Community Hospital Education Program and |
853 | the Graduate Medical Education Committee established pursuant to |
854 | s. 381.0403, area health education center networks established |
855 | pursuant to s. 381.0402, and other offices and programs within |
856 | the Department of Health as designated by the State Surgeon |
857 | General. |
858 | (h) Work in conjunction with and act as a coordinating |
859 | body for governmental and nongovernmental stakeholders to |
860 | address matters relating to the state's physician workforce |
861 | assessment and development for the purpose of ensuring an |
862 | adequate supply of well-trained physicians to meet the state's |
863 | future needs. Such governmental stakeholders shall include, but |
864 | need not be limited to, the State Surgeon General or his or her |
865 | designee, the Commissioner of Education or his or her designee, |
866 | the Secretary of Health Care Administration or his or her |
867 | designee, and the Chancellor of the State University System or |
868 | his or her designee from the Board of Governors of the State |
869 | University System, and, at the discretion of the department, |
870 | other representatives of state and local agencies that are |
871 | involved in assessing, educating, or training the state's |
872 | current or future physicians. Other stakeholders shall include, |
873 | but need not be limited to, organizations representing the |
874 | state's public and private allopathic and osteopathic medical |
875 | schools; organizations representing hospitals and other |
876 | institutions providing health care, particularly those that have |
877 | an interest in providing accredited medical education and |
878 | graduate medical education to medical students and medical |
879 | residents; organizations representing allopathic and osteopathic |
880 | practicing physicians; and, at the discretion of the department, |
881 | representatives of other organizations or entities involved in |
882 | assessing, educating, or training the state's current or future |
883 | physicians. |
884 | (i) Serve as a liaison with other states and federal |
885 | agencies and programs in order to enhance resources available to |
886 | the state's physician workforce and medical education continuum. |
887 | (j) Act as a clearinghouse for collecting and |
888 | disseminating information concerning the physician workforce and |
889 | medical education continuum in this state. |
890 | (5) PHYSICIAN WORKFORCE ADVISORY COUNCIL.-There is created |
891 | in the department the Physician Workforce Advisory Council, an |
892 | advisory council as defined in s. 20.03. The council shall |
893 | comply with the requirements of s. 20.052, except as otherwise |
894 | provided in this section. |
895 | (a) The council shall be composed of the following 23 |
896 | members: |
897 | 1. The following members appointed by the State Surgeon |
898 | General: |
899 | a. A designee from the department. |
900 | b. An individual recommended by the Area Health Education |
901 | Center Network. |
902 | c. Two individuals recommended by the Council of Florida |
903 | Medical School Deans, one representing a college of allopathic |
904 | medicine and one representing a college of osteopathic medicine. |
905 | d. Two individuals recommended by the Florida Hospital |
906 | Association, one representing a statutory teaching hospital and |
907 | one representing a hospital that is licensed under chapter 395, |
908 | has an accredited graduate medical education program, and is not |
909 | a statutory teaching hospital. |
910 | e. Two individuals recommended by the Florida Medical |
911 | Association, one representing a primary care specialty and one |
912 | representing a nonprimary care specialty. |
913 | f. Two individuals recommended by the Florida Osteopathic |
914 | Medical Association, one representing a primary care specialty |
915 | and one representing a nonprimary care specialty. |
916 | g. Two individuals who are program directors of accredited |
917 | graduate medical education programs, one representing a program |
918 | that is accredited by the Accreditation Council for Graduate |
919 | Medical Education and one representing a program that is |
920 | accredited by the American Osteopathic Association. |
921 | h. An individual recommended by the Florida Justice |
922 | Association. |
923 | i. An individual representing a profession in the field of |
924 | health services administration. |
925 | j. A layperson member. |
926 |
|
927 | Each entity authorized to make recommendations under this |
928 | subparagraph shall make at least two recommendations to the |
929 | State Surgeon General for each appointment to the council. The |
930 | State Surgeon General shall appoint one member for each position |
931 | from among the recommendations made by each authorized entity. |
932 | 2. The following members or designees appointed by the |
933 | respective agency head, legislative presiding officer, or |
934 | congressional delegation: |
935 | a. The Commissioner of Education or his or her designee. |
936 | b. The Chancellor of the State University System or his or |
937 | her designee. |
938 | c. The Secretary of Health Care Administration or his or |
939 | her designee. |
940 | d. The executive director of the Department of Veterans' |
941 | Affairs or his or her designee. |
942 | e. The Secretary of Elderly Affairs or his or her |
943 | designee. |
944 | f. The President of the Senate or his or her designee. |
945 | g. The Speaker of the House of Representatives or his or |
946 | her designee. |
947 | h. A designee of Florida's Congressional Delegation. |
948 | (b) Each council member shall be appointed to a 4-year |
949 | term. A member may not serve more than two full terms. Any |
950 | council member may be removed from office for malfeasance, |
951 | misfeasance, neglect of duty, incompetence, permanent inability |
952 | to perform official duties, or pleading guilty or nolo |
953 | contendere to, or being found guilty of, a felony. Any council |
954 | member who meets the criteria for removal, or who is otherwise |
955 | unwilling or unable to properly fulfill the duties of the |
956 | office, shall be succeeded by an individual chosen by the State |
957 | Surgeon General to serve out the remainder of the council |
958 | member's term. If the remainder of the replaced council member's |
959 | term is less than 18 months, notwithstanding the provisions of |
960 | this paragraph, the succeeding council member may be reappointed |
961 | twice by the State Surgeon General. |
962 | (c) The chair of the council is the State Surgeon General, |
963 | who shall designate a vice chair to serve in the absence of the |
964 | State Surgeon General. A vacancy shall be filled for the |
965 | remainder of the unexpired term in the same manner as the |
966 | original appointment. |
967 | (d) Council members are not entitled to receive |
968 | compensation or reimbursement for per diem or travel expenses. |
969 | (e) The council shall meet twice a year in person or by |
970 | teleconference. |
971 | (f) The council shall: |
972 | 1. Advise the State Surgeon General and the department on |
973 | matters concerning current and future physician workforce needs |
974 | in this state. |
975 | 2. Review survey materials and the compilation of survey |
976 | information. |
977 | 3. Provide recommendations to the department for the |
978 | development of additional items to be incorporated in the survey |
979 | completed by physicians licensed under chapter 458 or chapter |
980 | 459. |
981 | 4. Assist the department in preparing the annual report to |
982 | the Legislature pursuant to ss. 458.3192 and 459.0082. |
983 | 5. Assist the department in preparing an initial strategic |
984 | plan, conducting ongoing strategic planning in accordance with |
985 | this section, and providing ongoing advice on implementing the |
986 | recommendations. |
987 | 6. Monitor the need for an increased number of primary |
988 | care physicians to provide the necessary current and projected |
989 | health and medical services for the state. |
990 | 7. Monitor the status of graduate medical education in |
991 | this state, including, but not limited to, as considered |
992 | appropriate: |
993 | a. The role of residents and medical faculty in the |
994 | provision of health care. |
995 | b. The relationship of graduate medical education to the |
996 | state's physician workforce. |
997 | c. The availability and use of state and federal |
998 | appropriated funds for graduate medical education. |
999 | Section 8. Section 392.51, Florida Statutes, is amended to |
1000 | read: |
1001 | 392.51 Findings and intent.-The Legislature finds and |
1002 | declares that active tuberculosis is a highly contagious |
1003 | infection that is sometimes fatal and constitutes a serious |
1004 | threat to the public health. The Legislature finds that there is |
1005 | a significant reservoir of tuberculosis infection in this state |
1006 | and that there is a need to develop community programs to |
1007 | identify tuberculosis and to respond quickly with appropriate |
1008 | measures. The Legislature finds that some patients who have |
1009 | active tuberculosis have complex medical, social, and economic |
1010 | problems that make outpatient control of the disease difficult, |
1011 | if not impossible, without posing a threat to the public health. |
1012 | The Legislature finds that in order to protect the citizenry |
1013 | from those few persons who pose a threat to the public, it is |
1014 | necessary to establish a system of mandatory contact |
1015 | identification, treatment to cure, hospitalization, and |
1016 | isolation for contagious cases and to provide a system of |
1017 | voluntary, community-oriented care and surveillance in all other |
1018 | cases. The Legislature finds that the delivery of tuberculosis |
1019 | control services is best accomplished by the coordinated efforts |
1020 | of the respective county health departments, the A.G. Holley |
1021 | State Hospital, and the private health care delivery system. |
1022 | Section 9. Subsection (5) is added to section 392.69, |
1023 | Florida Statutes, to read: |
1024 | 392.69 Appropriation, sinking, and maintenance trust |
1025 | funds; additional powers of the department.- |
1026 | (5) The department shall develop a plan that exclusively |
1027 | uses private and nonstate public hospitals to provide treatment |
1028 | to cure, hospitalization, and isolation for persons with |
1029 | contagious cases of tuberculosis who pose a threat to the |
1030 | public. The department shall submit the plan to the Governor, |
1031 | the President of the Senate, and the Speaker of the House of |
1032 | Representatives by November 1, 2010. The plan shall include the |
1033 | following elements: |
1034 | (a) Identification of hospitals functionally capable of |
1035 | caring for such patients. |
1036 | (b) Reimbursement for hospital inpatient services at the |
1037 | Medicaid rate and reimbursement for other medically necessary |
1038 | services that are not hospital inpatient services at the |
1039 | relevant Medicaid rate. |
1040 | (c) Projected cost estimates. |
1041 | (d) A transition plan for closing the A. G. Holley State |
1042 | Hospital and transferring patients to private and nonstate |
1043 | public hospitals over a 90-day period of time. |
1044 | Section 10. Paragraph (d) of subsection (5) of section |
1045 | 411.01, Florida Statutes, is amended to read: |
1046 | 411.01 School readiness programs; early learning |
1047 | coalitions.- |
1048 | (5) CREATION OF EARLY LEARNING COALITIONS.- |
1049 | (d) Implementation.- |
1050 | 1. An early learning coalition may not implement the |
1051 | school readiness program until the coalition is authorized |
1052 | through approval of the coalition's school readiness plan by the |
1053 | Agency for Workforce Innovation. |
1054 | 2. Each early learning coalition shall develop a plan for |
1055 | implementing the school readiness program to meet the |
1056 | requirements of this section and the performance standards and |
1057 | outcome measures adopted by the Agency for Workforce Innovation. |
1058 | The plan must demonstrate how the program will ensure that each |
1059 | 3-year-old and 4-year-old child in a publicly funded school |
1060 | readiness program receives scheduled activities and instruction |
1061 | designed to enhance the age-appropriate progress of the children |
1062 | in attaining the performance standards adopted by the Agency for |
1063 | Workforce Innovation under subparagraph (4)(d)8. Before |
1064 | implementing the school readiness program, the early learning |
1065 | coalition must submit the plan to the Agency for Workforce |
1066 | Innovation for approval. The Agency for Workforce Innovation may |
1067 | approve the plan, reject the plan, or approve the plan with |
1068 | conditions. The Agency for Workforce Innovation shall review |
1069 | school readiness plans at least annually. |
1070 | 3. If the Agency for Workforce Innovation determines |
1071 | during the annual review of school readiness plans, or through |
1072 | monitoring and performance evaluations conducted under paragraph |
1073 | (4)(l), that an early learning coalition has not substantially |
1074 | implemented its plan, has not substantially met the performance |
1075 | standards and outcome measures adopted by the agency, or has not |
1076 | effectively administered the school readiness program or |
1077 | Voluntary Prekindergarten Education Program, the Agency for |
1078 | Workforce Innovation may dissolve the coalition and temporarily |
1079 | contract with a qualified entity to continue school readiness |
1080 | and prekindergarten services in the coalition's county or |
1081 | multicounty region until the coalition is reestablished through |
1082 | resubmission of a school readiness plan and approval by the |
1083 | agency. |
1084 | 4. The Agency for Workforce Innovation shall adopt |
1085 | criteria for the approval of school readiness plans. The |
1086 | criteria must be consistent with the performance standards and |
1087 | outcome measures adopted by the agency and must require each |
1088 | approved plan to include the following minimum standards and |
1089 | provisions: |
1090 | a. A sliding fee scale establishing a copayment for |
1091 | parents based upon their ability to pay, which is the same for |
1092 | all program providers, to be implemented and reflected in each |
1093 | program's budget. |
1094 | b. A choice of settings and locations in licensed, |
1095 | registered, religious-exempt, or school-based programs to be |
1096 | provided to parents. |
1097 | c. Instructional staff who have completed the training |
1098 | course as required in s. 402.305(2)(d)1., as well as staff who |
1099 | have additional training or credentials as required by the |
1100 | Agency for Workforce Innovation. The plan must provide a method |
1101 | for assuring the qualifications of all personnel in all program |
1102 | settings. |
1103 | d. Specific eligibility priorities for children within the |
1104 | early learning coalition's county or multicounty region in |
1105 | accordance with subsection (6). |
1106 | e. Performance standards and outcome measures adopted by |
1107 | the Agency for Workforce Innovation. |
1108 | f. Payment rates adopted by the early learning coalition |
1109 | and approved by the Agency for Workforce Innovation. Payment |
1110 | rates may not have the effect of limiting parental choice or |
1111 | creating standards or levels of services that have not been |
1112 | authorized by the Legislature. |
1113 | g. Systems support services, including a central agency, |
1114 | child care resource and referral, eligibility determinations, |
1115 | training of providers, and parent support and involvement. |
1116 | h. Direct enhancement services to families and children. |
1117 | System support and direct enhancement services shall be in |
1118 | addition to payments for the placement of children in school |
1119 | readiness programs. |
1120 | i. The business organization of the early learning |
1121 | coalition, which must include the coalition's articles of |
1122 | incorporation and bylaws if the coalition is organized as a |
1123 | corporation. If the coalition is not organized as a corporation |
1124 | or other business entity, the plan must include the contract |
1125 | with a fiscal agent. An early learning coalition may contract |
1126 | with other coalitions to achieve efficiency in multicounty |
1127 | services, and these contracts may be part of the coalition's |
1128 | school readiness plan. |
1129 | j. Strategies to meet the needs of unique populations, |
1130 | such as migrant workers. |
1131 |
|
1132 | As part of the school readiness plan, the early learning |
1133 | coalition may request the Governor to apply for a waiver to |
1134 | allow the coalition to administer the Head Start Program to |
1135 | accomplish the purposes of the school readiness program. If a |
1136 | school readiness plan demonstrates that specific statutory goals |
1137 | can be achieved more effectively by using procedures that |
1138 | require modification of existing rules, policies, or procedures, |
1139 | a request for a waiver to the Agency for Workforce Innovation |
1140 | may be submitted as part of the plan. Upon review, the Agency |
1141 | for Workforce Innovation may grant the proposed modification. |
1142 | 5. Persons with an early childhood teaching certificate |
1143 | may provide support and supervision to other staff in the school |
1144 | readiness program. |
1145 | 6. An early learning coalition may not implement its |
1146 | school readiness plan until it submits the plan to and receives |
1147 | approval from the Agency for Workforce Innovation. Once the plan |
1148 | is approved, the plan and the services provided under the plan |
1149 | shall be controlled by the early learning coalition. The plan |
1150 | shall be reviewed and revised as necessary, but at least |
1151 | biennially. An early learning coalition may not implement the |
1152 | revisions until the coalition submits the revised plan to and |
1153 | receives approval from the Agency for Workforce Innovation. If |
1154 | the Agency for Workforce Innovation rejects a revised plan, the |
1155 | coalition must continue to operate under its prior approved |
1156 | plan. |
1157 | 7. Sections 125.901(2)(a)3. and, 411.221, and 411.232 do |
1158 | not apply to an early learning coalition with an approved school |
1159 | readiness plan. To facilitate innovative practices and to allow |
1160 | the regional establishment of school readiness programs, an |
1161 | early learning coalition may apply to the Governor and Cabinet |
1162 | for a waiver of, and the Governor and Cabinet may waive, any of |
1163 | the provisions of ss. 411.223, 411.232, and 1003.54, if the |
1164 | waiver is necessary for implementation of the coalition's school |
1165 | readiness plan. |
1166 | 8. Two or more counties may join for purposes of planning |
1167 | and implementing a school readiness program. |
1168 | 9. An early learning coalition may, subject to approval by |
1169 | the Agency for Workforce Innovation as part of the coalition's |
1170 | school readiness plan, receive subsidized child care funds for |
1171 | all children eligible for any federal subsidized child care |
1172 | program. |
1173 | 10. An early learning coalition may enter into multiparty |
1174 | contracts with multicounty service providers in order to meet |
1175 | the needs of unique populations such as migrant workers. |
1176 | Section 11. Paragraphs (f) and (g) of subsection (2) of |
1177 | section 411.224, Florida Statutes, are redesignated as |
1178 | paragraphs (e) and (f), respectively, and present paragraph (e) |
1179 | of that subsection is amended to read: |
1180 | 411.224 Family support planning process.-The Legislature |
1181 | establishes a family support planning process to be used by the |
1182 | Department of Children and Family Services as the service |
1183 | planning process for targeted individuals, children, and |
1184 | families under its purview. |
1185 | (2) To the extent possible within existing resources, the |
1186 | following populations must be included in the family support |
1187 | planning process: |
1188 | (e) Participants who are served by the Children's Early |
1189 | Investment Program established in s. 411.232. |
1190 | Section 12. Subsection (5) is added to section 456.074, |
1191 | Florida Statutes, to read: |
1192 | 456.074 Certain health care practitioners; immediate |
1193 | suspension of license.- |
1194 | (5) Effective July 1, 2011, before issuing an emergency |
1195 | order suspending the license of a physician licensed under |
1196 | chapter 458, chapter 459, or chapter 461 or a dentist licensed |
1197 | under chapter 466, the Secretary of Business and Professional |
1198 | Regulation shall consult with, and receive a recommendation |
1199 | from, the State Surgeon General. The State Surgeon General shall |
1200 | provide a recommendation within 24 hours after the consultation. |
1201 | Section 13. Section 458.3192, Florida Statutes, is amended |
1202 | to read: |
1203 | 458.3192 Analysis of survey results; report.- |
1204 | (1) Each year, the Department of Health shall analyze the |
1205 | results of the physician survey required by s. 458.3191 and |
1206 | determine by geographic area and specialty the number of |
1207 | physicians who: |
1208 | (a) Perform deliveries of children in this state Florida. |
1209 | (b) Read mammograms and perform breast-imaging-guided |
1210 | procedures in this state Florida. |
1211 | (c) Perform emergency care on an on-call basis for a |
1212 | hospital emergency department. |
1213 | (d) Plan to reduce or increase emergency on-call hours in |
1214 | a hospital emergency department. |
1215 | (e) Plan to relocate their allopathic or osteopathic |
1216 | practice outside the state. |
1217 | (f) Practice medicine in this state. |
1218 | (g) Reduce or modify the scope of their practice. |
1219 | (2) The Department of Health must report its findings to |
1220 | the Governor, the President of the Senate, and the Speaker of |
1221 | the House of Representatives by November 1 each year. The |
1222 | department may also include in its report findings, |
1223 | recommendations, or other information requested by the council. |
1224 | Section 14. Section 459.0082, Florida Statutes, is amended |
1225 | to read: |
1226 | 459.0082 Analysis of survey results; report.- |
1227 | (1) Each year, the Department of Health shall analyze the |
1228 | results of the physician survey required by s. 459.0081 and |
1229 | determine by geographic area and specialty the number of |
1230 | physicians who: |
1231 | (a) Perform deliveries of children in this state Florida. |
1232 | (b) Read mammograms and perform breast-imaging-guided |
1233 | procedures in this state Florida. |
1234 | (c) Perform emergency care on an on-call basis for a |
1235 | hospital emergency department. |
1236 | (d) Plan to reduce or increase emergency on-call hours in |
1237 | a hospital emergency department. |
1238 | (e) Plan to relocate their allopathic or osteopathic |
1239 | practice outside the state. |
1240 | (f) Practice medicine in this state. |
1241 | (g) Reduce or modify the scope of their practice. |
1242 | (2) The Department of Health must report its findings to |
1243 | the Governor, the President of the Senate, and the Speaker of |
1244 | the House of Representatives by November 1 each year. The |
1245 | department may also include in its report findings, |
1246 | recommendations, or other information requested by the council. |
1247 | Section 15. Subsections (32) through (54) of section |
1248 | 499.003, Florida Statutes, are renumbered as subsections (33) |
1249 | through (55), respectively, present subsection (42) and |
1250 | paragraph (a) of present subsection (53) are amended, and a new |
1251 | subsection (32) is added to that subsection, to read: |
1252 | 499.003 Definitions of terms used in this part.-As used in |
1253 | this part, the term: |
1254 | (32) "Medical convenience kit" means packages or units |
1255 | that contain combination products as defined in 21 C.F.R. s. |
1256 | 3.2(e)(2). |
1257 | (43)(42) "Prescription drug" means a prescription, |
1258 | medicinal, or legend drug, including, but not limited to, |
1259 | finished dosage forms or active ingredients subject to, defined |
1260 | by, or described by s. 503(b) of the Federal Food, Drug, and |
1261 | Cosmetic Act or s. 465.003(8), s. 499.007(13), or subsection |
1262 | (11), subsection (46) (45), or subsection (53) (52). |
1263 | (54)(53) "Wholesale distribution" means distribution of |
1264 | prescription drugs to persons other than a consumer or patient, |
1265 | but does not include: |
1266 | (a) Any of the following activities, which is not a |
1267 | violation of s. 499.005(21) if such activity is conducted in |
1268 | accordance with s. 499.01(2)(g): |
1269 | 1. The purchase or other acquisition by a hospital or |
1270 | other health care entity that is a member of a group purchasing |
1271 | organization of a prescription drug for its own use from the |
1272 | group purchasing organization or from other hospitals or health |
1273 | care entities that are members of that organization. |
1274 | 2. The sale, purchase, or trade of a prescription drug or |
1275 | an offer to sell, purchase, or trade a prescription drug by a |
1276 | charitable organization described in s. 501(c)(3) of the |
1277 | Internal Revenue Code of 1986, as amended and revised, to a |
1278 | nonprofit affiliate of the organization to the extent otherwise |
1279 | permitted by law. |
1280 | 3. The sale, purchase, or trade of a prescription drug or |
1281 | an offer to sell, purchase, or trade a prescription drug among |
1282 | hospitals or other health care entities that are under common |
1283 | control. For purposes of this subparagraph, "common control" |
1284 | means the power to direct or cause the direction of the |
1285 | management and policies of a person or an organization, whether |
1286 | by ownership of stock, by voting rights, by contract, or |
1287 | otherwise. |
1288 | 4. The sale, purchase, trade, or other transfer of a |
1289 | prescription drug from or for any federal, state, or local |
1290 | government agency or any entity eligible to purchase |
1291 | prescription drugs at public health services prices pursuant to |
1292 | Pub. L. No. 102-585, s. 602 to a contract provider or its |
1293 | subcontractor for eligible patients of the agency or entity |
1294 | under the following conditions: |
1295 | a. The agency or entity must obtain written authorization |
1296 | for the sale, purchase, trade, or other transfer of a |
1297 | prescription drug under this subparagraph from the State Surgeon |
1298 | General or his or her designee. |
1299 | b. The contract provider or subcontractor must be |
1300 | authorized by law to administer or dispense prescription drugs. |
1301 | c. In the case of a subcontractor, the agency or entity |
1302 | must be a party to and execute the subcontract. |
1303 | d. A contract provider or subcontractor must maintain |
1304 | separate and apart from other prescription drug inventory any |
1305 | prescription drugs of the agency or entity in its possession. |
1306 | d.e. The contract provider and subcontractor must maintain |
1307 | and produce immediately for inspection all records of movement |
1308 | or transfer of all the prescription drugs belonging to the |
1309 | agency or entity, including, but not limited to, the records of |
1310 | receipt and disposition of prescription drugs. Each contractor |
1311 | and subcontractor dispensing or administering these drugs must |
1312 | maintain and produce records documenting the dispensing or |
1313 | administration. Records that are required to be maintained |
1314 | include, but are not limited to, a perpetual inventory itemizing |
1315 | drugs received and drugs dispensed by prescription number or |
1316 | administered by patient identifier, which must be submitted to |
1317 | the agency or entity quarterly. |
1318 | e.f. The contract provider or subcontractor may administer |
1319 | or dispense the prescription drugs only to the eligible patients |
1320 | of the agency or entity or must return the prescription drugs |
1321 | for or to the agency or entity. The contract provider or |
1322 | subcontractor must require proof from each person seeking to |
1323 | fill a prescription or obtain treatment that the person is an |
1324 | eligible patient of the agency or entity and must, at a minimum, |
1325 | maintain a copy of this proof as part of the records of the |
1326 | contractor or subcontractor required under sub-subparagraph d. |
1327 | e. |
1328 | f.g. In addition to the departmental inspection authority |
1329 | set forth in s. 499.051, the establishment of the contract |
1330 | provider and subcontractor and all records pertaining to |
1331 | prescription drugs subject to this subparagraph shall be subject |
1332 | to inspection by the agency or entity. All records relating to |
1333 | prescription drugs of a manufacturer under this subparagraph |
1334 | shall be subject to audit by the manufacturer of those drugs, |
1335 | without identifying individual patient information. |
1336 | Section 16. Paragraph (q) of subsection (2) of section |
1337 | 499.01, Florida Statutes, is amended to read: |
1338 | 499.01 Permits.- |
1339 | (2) The following permits are established: |
1340 | (q) Device manufacturer permit.- |
1341 | 1. A device manufacturer permit is required for any person |
1342 | that engages in the manufacture, repackaging, or assembly of |
1343 | medical devices for human use in this state, except that a |
1344 | permit is not required if: |
1345 | a. The person is engaged only in manufacturing, |
1346 | repackaging, or assembling a medical device pursuant to a |
1347 | practitioner's order for a specific patient; or |
1348 | b. The person does not manufacture, repackage, or assemble |
1349 | any medical devices or components for such devices, except those |
1350 | devices or components which are exempt from registration |
1351 | pursuant to s. 499.015(8). |
1352 | 2.1. A manufacturer or repackager of medical devices in |
1353 | this state must comply with all appropriate state and federal |
1354 | good manufacturing practices and quality system rules. |
1355 | 3.2. The department shall adopt rules related to storage, |
1356 | handling, and recordkeeping requirements for manufacturers of |
1357 | medical devices for human use. |
1358 | Section 17. Paragraph (i) is added to subsection (3) of |
1359 | section 499.01212, Florida Statutes, to read: |
1360 | 499.01212 Pedigree paper.- |
1361 | (3) EXCEPTIONS.-A pedigree paper is not required for: |
1362 | (i) The wholesale distribution of prescription drugs |
1363 | within a medical convenience kit if: |
1364 | 1. The medical convenience kit is assembled in an |
1365 | establishment that is registered with the United States Food and |
1366 | Drug Administration as a medical device manufacturer; |
1367 | 2. The medical convenience kit manufacturer is an |
1368 | authorized distributor of record, as defined by 21 C.F.R. s. |
1369 | 203.3, for the manufacturer of the specific drugs contained |
1370 | within the kit; and |
1371 | 3. The drugs contained in the medical convenience kit are: |
1372 | a. Intravenous solutions intended for the replenishment of |
1373 | fluids and electrolytes; |
1374 | b. Products intended to maintain the equilibrium of water |
1375 | and minerals in the body; |
1376 | c. Products intended for irrigation or reconstitution; |
1377 | d. Anesthetics; or |
1378 | e. Anticoagulants. |
1379 |
|
1380 | This paragraph does not apply to a medical convenience kit |
1381 | containing any controlled substance that appears in any schedule |
1382 | contained in or subject to chapter 893 or the Federal |
1383 | Comprehensive Drug Abuse Prevention and Control Act of 1970. |
1384 | Section 18. Section 499.029, Florida Statutes, is amended |
1385 | to read: |
1386 | 499.029 Prescription Cancer Drug Donation Program.- |
1387 | (1) This section may be cited as the Prescription "Cancer |
1388 | Drug Donation Program Act." |
1389 | (2) There is created a Prescription Cancer Drug Donation |
1390 | Program within the department for the purpose of authorizing and |
1391 | facilitating the donation of prescription cancer drugs and |
1392 | supplies to eligible patients. |
1393 | (3) As used in this section, the term: |
1394 | (a) "Cancer drug" means a prescription drug that has been |
1395 | approved under s. 505 of the federal Food, Drug, and Cosmetic |
1396 | Act and is used to treat cancer or its side effects or is used |
1397 | to treat the side effects of a prescription drug used to treat |
1398 | cancer or its side effects. "Cancer drug" does not include a |
1399 | substance listed in Schedule II, Schedule III, Schedule IV, or |
1400 | Schedule V of s. 893.03. |
1401 | (a)(b) "Closed drug delivery system" means a system in |
1402 | which the actual control of the unit-dose medication package is |
1403 | maintained by the facility rather than by the individual |
1404 | patient. |
1405 | (b) "Dispensing practitioner" means a practitioner |
1406 | registered under s. 465.0276. |
1407 | (c) "Donor" means a patient or patient representative who |
1408 | donates prescription cancer drugs or supplies needed to |
1409 | administer prescription cancer drugs that have been maintained |
1410 | within a closed drug delivery system; health care facilities, |
1411 | nursing homes, hospices, or hospitals with closed drug delivery |
1412 | systems; or pharmacies, prescription drug manufacturers, medical |
1413 | device manufacturers or suppliers, or wholesalers of |
1414 | prescription drugs or supplies, in accordance with this section. |
1415 | The term "donor" includes a physician licensed under chapter 458 |
1416 | or chapter 459 who receives prescription cancer drugs or |
1417 | supplies directly from a drug manufacturer, wholesale |
1418 | distributor, or pharmacy. |
1419 | (d) "Eligible patient" means a person who the department |
1420 | determines is eligible to receive prescription cancer drugs from |
1421 | the program. |
1422 | (e) "Participant facility" means a class II hospital |
1423 | pharmacy or dispensing practitioner that has elected to |
1424 | participate in the program and that accepts donated prescription |
1425 | cancer drugs and supplies under the rules adopted by the |
1426 | department for the program. |
1427 | (f) "Prescribing practitioner" means a physician licensed |
1428 | under chapter 458 or chapter 459 or any other medical |
1429 | professional with authority under state law to prescribe drugs |
1430 | cancer medication. |
1431 | (g) "Prescription drug" does not include a substance |
1432 | listed in Schedule II, Schedule III, Schedule IV, or Schedule V |
1433 | of s. 893.03. |
1434 | (h)(g) "Program" means the Prescription Cancer Drug |
1435 | Donation Program created by this section. |
1436 | (i)(h) "Supplies" means any supplies used in the |
1437 | administration of a prescription cancer drug. |
1438 | (4) Any donor may donate prescription cancer drugs or |
1439 | supplies to a participant facility that elects to participate in |
1440 | the program and meets criteria established by the department for |
1441 | such participation. Prescription Cancer drugs or supplies may |
1442 | not be donated to a specific cancer patient, and donated |
1443 | prescription drugs or supplies may not be resold by the |
1444 | participant program. Prescription Cancer drugs billed to and |
1445 | paid for by Medicaid in long-term care facilities that are |
1446 | eligible for return to stock under federal Medicaid regulations |
1447 | shall be credited to Medicaid and are not eligible for donation |
1448 | under the program. A participant facility may provide dispensing |
1449 | and counseling consulting services to individuals who are not |
1450 | patients of the participant hospital. |
1451 | (5) The prescription cancer drugs or supplies donated to |
1452 | the program may be prescribed only by a prescribing practitioner |
1453 | for use by an eligible patient and may be dispensed only by a |
1454 | pharmacist or a dispensing practitioner. |
1455 | (6)(a) A prescription cancer drug may only be accepted or |
1456 | dispensed under the program if the drug is in its original, |
1457 | unopened, sealed container, or in a tamper-evident unit-dose |
1458 | packaging, except that a prescription cancer drug packaged in |
1459 | single-unit doses may be accepted and dispensed if the outside |
1460 | packaging is opened but the single-unit-dose packaging is |
1461 | unopened with tamper-resistant packaging intact. |
1462 | (b) A prescription cancer drug may not be accepted or |
1463 | dispensed under the program if the drug bears an expiration date |
1464 | that is less than 6 months after the date the drug was donated |
1465 | or if the drug appears to have been tampered with or mislabeled |
1466 | as determined in paragraph (c). |
1467 | (c) Before Prior to being dispensed to an eligible |
1468 | patient, the prescription cancer drug or supplies donated under |
1469 | the program shall be inspected by a pharmacist or dispensing |
1470 | practitioner to determine that the drug and supplies do not |
1471 | appear to have been tampered with or mislabeled. |
1472 | (d) A dispenser of donated prescription cancer drugs or |
1473 | supplies may not submit a claim or otherwise seek reimbursement |
1474 | from any public or private third-party payor for donated |
1475 | prescription cancer drugs or supplies dispensed to any patient |
1476 | under the program, and a public or private third-party payor is |
1477 | not required to provide reimbursement to a dispenser for donated |
1478 | prescription cancer drugs or supplies dispensed to any patient |
1479 | under the program. |
1480 | (7)(a) A donation of prescription cancer drugs or supplies |
1481 | shall be made only at a participant's participant facility. A |
1482 | participant facility may decline to accept a donation. A |
1483 | participant facility that accepts donated prescription cancer |
1484 | drugs or supplies under the program shall comply with all |
1485 | applicable provisions of state and federal law relating to the |
1486 | storage and dispensing of the donated prescription cancer drugs |
1487 | or supplies. |
1488 | (b) A participant facility that voluntarily takes part in |
1489 | the program may charge a handling fee sufficient to cover the |
1490 | cost of preparation and dispensing of prescription cancer drugs |
1491 | or supplies under the program. The fee shall be established in |
1492 | rules adopted by the department. |
1493 | (8) The department, upon the recommendation of the Board |
1494 | of Pharmacy, shall adopt rules to carry out the provisions of |
1495 | this section. Initial rules under this section shall be adopted |
1496 | no later than 90 days after the effective date of this act. The |
1497 | rules shall include, but not be limited to: |
1498 | (a) Eligibility criteria, including a method to determine |
1499 | priority of eligible patients under the program. |
1500 | (b) Standards and procedures for participants participant |
1501 | facilities that accept, store, distribute, or dispense donated |
1502 | prescription cancer drugs or supplies. |
1503 | (c) Necessary forms for administration of the program, |
1504 | including, but not limited to, forms for use by entities that |
1505 | donate, accept, distribute, or dispense prescription cancer |
1506 | drugs or supplies under the program. |
1507 | (d) The maximum handling fee that may be charged by a |
1508 | participant facility that accepts and distributes or dispenses |
1509 | donated prescription cancer drugs or supplies. |
1510 | (e) Categories of prescription cancer drugs and supplies |
1511 | that the program will accept for dispensing; however, the |
1512 | department may exclude any drug based on its therapeutic |
1513 | effectiveness or high potential for abuse or diversion. |
1514 | (f) Maintenance and distribution of the participant |
1515 | facility registry established in subsection (10). |
1516 | (9) A person who is eligible to receive prescription |
1517 | cancer drugs or supplies under the state Medicaid program or |
1518 | under any other prescription drug program funded in whole or in |
1519 | part by the state, by any other prescription drug program funded |
1520 | in whole or in part by the Federal Government, or by any other |
1521 | prescription drug program offered by a third-party insurer, |
1522 | unless benefits have been exhausted, or a certain prescription |
1523 | cancer drug or supply is not covered by the prescription drug |
1524 | program, is ineligible to participate in the program created |
1525 | under this section. |
1526 | (10) The department shall establish and maintain a |
1527 | participant facility registry for the program. The participant |
1528 | facility registry shall include the participant's participant |
1529 | facility's name, address, and telephone number. The department |
1530 | shall make the participant facility registry available on the |
1531 | department's website to any donor wishing to donate prescription |
1532 | cancer drugs or supplies to the program. The department's |
1533 | website shall also contain links to prescription cancer drug |
1534 | manufacturers that offer drug assistance programs or free |
1535 | medication. |
1536 | (11) Any donor of prescription cancer drugs or supplies, |
1537 | or any participant in the program, who exercises reasonable care |
1538 | in donating, accepting, distributing, or dispensing prescription |
1539 | cancer drugs or supplies under the program and the rules adopted |
1540 | under this section shall be immune from civil or criminal |
1541 | liability and from professional disciplinary action of any kind |
1542 | for any injury, death, or loss to person or property relating to |
1543 | such activities. |
1544 | (12) A pharmaceutical manufacturer is not liable for any |
1545 | claim or injury arising from the transfer of any prescription |
1546 | cancer drug under this section, including, but not limited to, |
1547 | liability for failure to transfer or communicate product or |
1548 | consumer information regarding the transferred drug, as well as |
1549 | the expiration date of the transferred drug. |
1550 | (13) If any conflict exists between the provisions in this |
1551 | section and the provisions in this chapter or chapter 465, the |
1552 | provisions in this section shall control the operation of the |
1553 | Cancer Drug Donation program. |
1554 | Section 19. Subsections (4) and (5) of section 509.013, |
1555 | Florida Statutes, are amended to read: |
1556 | 509.013 Definitions.-As used in this chapter, the term: |
1557 | (4)(a) "Public lodging establishment" includes a transient |
1558 | public lodging establishment as defined in subparagraph 1. and a |
1559 | nontransient public lodging establishment as defined in |
1560 | subparagraph 2. |
1561 | 1. "Transient public lodging establishment" means any |
1562 | unit, group of units, dwelling, building, or group of buildings |
1563 | within a single complex of buildings which is rented to guests |
1564 | more than three times in a calendar year for periods of less |
1565 | than 30 days or 1 calendar month, whichever is less, or which is |
1566 | advertised or held out to the public as a place regularly rented |
1567 | to guests. |
1568 | 2. "Nontransient public lodging establishment" means any |
1569 | unit, group of units, dwelling, building, or group of buildings |
1570 | within a single complex of buildings which is rented to guests |
1571 | for periods of at least 30 days or 1 calendar month, whichever |
1572 | is less, or which is advertised or held out to the public as a |
1573 | place regularly rented to guests for periods of at least 30 days |
1574 | or 1 calendar month. |
1575 |
|
1576 | License classifications of public lodging establishments, and |
1577 | the definitions therefor, are set out in s. 509.242. For the |
1578 | purpose of licensure, the term does not include condominium |
1579 | common elements as defined in s. 718.103. |
1580 | (b) The following are excluded from the definitions in |
1581 | paragraph (a): |
1582 | 1. Any dormitory or other living or sleeping facility |
1583 | maintained by a public or private school, college, or university |
1584 | for the use of students, faculty, or visitors; |
1585 | 2. Any facility certified or licensed and regulated by the |
1586 | Agency for Health Care Administration or the Department of |
1587 | Children and Family Services hospital, nursing home, sanitarium, |
1588 | assisted living facility, or other similar place regulated under |
1589 | s. 381.0072; |
1590 | 3. Any place renting four rental units or less, unless the |
1591 | rental units are advertised or held out to the public to be |
1592 | places that are regularly rented to transients; |
1593 | 4. Any unit or group of units in a condominium, |
1594 | cooperative, or timeshare plan and any individually or |
1595 | collectively owned one-family, two-family, three-family, or |
1596 | four-family dwelling house or dwelling unit that is rented for |
1597 | periods of at least 30 days or 1 calendar month, whichever is |
1598 | less, and that is not advertised or held out to the public as a |
1599 | place regularly rented for periods of less than 1 calendar |
1600 | month, provided that no more than four rental units within a |
1601 | single complex of buildings are available for rent; |
1602 | 5. Any migrant labor camp or residential migrant housing |
1603 | permitted by the Department of Health; under ss. 381.008- |
1604 | 381.00895; and |
1605 | 6. Any establishment inspected by the Department of Health |
1606 | and regulated by chapter 513. |
1607 | (5)(a) "Public food service establishment" means any |
1608 | building, vehicle, place, or structure, or any room or division |
1609 | in a building, vehicle, place, or structure where food is |
1610 | prepared, served, or sold for immediate consumption on or in the |
1611 | vicinity of the premises; called for or taken out by customers; |
1612 | or prepared prior to being delivered to another location for |
1613 | consumption. |
1614 | (b) The following are excluded from the definition in |
1615 | paragraph (a): |
1616 | 1. Any place maintained and operated by a public or |
1617 | private school, college, or university: |
1618 | a. For the use of students and faculty; or |
1619 | b. Temporarily to serve such events as fairs, carnivals, |
1620 | and athletic contests. |
1621 | 2. Any eating place maintained and operated by a church or |
1622 | a religious, nonprofit fraternal, or nonprofit civic |
1623 | organization: |
1624 | a. For the use of members and associates; or |
1625 | b. Temporarily to serve such events as fairs, carnivals, |
1626 | or athletic contests. |
1627 | 3. Any eating place located on an airplane, train, bus, or |
1628 | watercraft which is a common carrier. |
1629 | 4. Any eating place maintained by a facility certified or |
1630 | licensed and regulated by the Agency for Health Care |
1631 | Administration or the Department of Children and Family Services |
1632 | hospital, nursing home, sanitarium, assisted living facility, |
1633 | adult day care center, or other similar place that is regulated |
1634 | under s. 381.0072. |
1635 | 5. Any place of business issued a permit or inspected by |
1636 | the Department of Agriculture and Consumer Services under s. |
1637 | 500.12. |
1638 | 6. Any place of business where the food available for |
1639 | consumption is limited to ice, beverages with or without |
1640 | garnishment, popcorn, or prepackaged items sold without |
1641 | additions or preparation. |
1642 | 7. Any theater, if the primary use is as a theater and if |
1643 | patron service is limited to food items customarily served to |
1644 | the admittees of theaters. |
1645 | 8. Any vending machine that dispenses any food or |
1646 | beverages other than potentially hazardous foods, as defined by |
1647 | division rule. |
1648 | 9. Any vending machine that dispenses potentially |
1649 | hazardous food and which is located in a facility regulated |
1650 | under s. 381.0072. |
1651 | 10. Any research and development test kitchen limited to |
1652 | the use of employees and which is not open to the general |
1653 | public. |
1654 | Section 20. (1) All of the statutory powers, duties, and |
1655 | functions, records, personnel, property, and unexpended balances |
1656 | of appropriations, allocations, or other funds for the |
1657 | administration of part I of chapter 499, Florida Statutes, |
1658 | relating to drugs, devices, cosmetics, and household products |
1659 | shall be transferred by a type two transfer, as defined in s. |
1660 | 20.06(2), Florida Statutes, from the Department of Health to the |
1661 | Department of Business and Professional Regulation. |
1662 | (2) The transfer of regulatory authority under part I of |
1663 | chapter 499, Florida Statutes, provided by this section shall |
1664 | not affect the validity of any judicial or administrative action |
1665 | pending as of 11:59 p.m. on the day before the effective date of |
1666 | this section to which the Department of Health is at that time a |
1667 | party, and the Department of Business and Professional |
1668 | Regulation shall be substituted as a party in interest in any |
1669 | such action. |
1670 | (3) All lawful orders issued by the Department of Health |
1671 | implementing or enforcing or otherwise in regard to any |
1672 | provision of part I of chapter 499, Florida Statutes, issued |
1673 | prior to the effective date of this section shall remain in |
1674 | effect and be enforceable after the effective date of this |
1675 | section unless thereafter modified in accordance with law. |
1676 | (4) The rules of the Department of Health relating to the |
1677 | implementation of part I of chapter 499, Florida Statutes, that |
1678 | were in effect at 11:59 p.m. on the day prior to the effective |
1679 | date of this section shall become the rules of the Department of |
1680 | Business and Professional Regulation and shall remain in effect |
1681 | until amended or repealed in the manner provided by law. |
1682 | (5) Notwithstanding the transfer of regulatory authority |
1683 | under part I of chapter 499, Florida Statutes, provided by this |
1684 | section, persons and entities holding in good standing any |
1685 | permit under part I of chapter 499, Florida Statutes, as of |
1686 | 11:59 p.m. on the day prior to the effective date of this |
1687 | section shall, as of the effective date of this section, be |
1688 | deemed to hold in good standing a permit in the same capacity as |
1689 | that for which the permit was formerly issued. |
1690 | (6) Notwithstanding the transfer of regulatory authority |
1691 | under part I of chapter 499, Florida Statutes, provided by this |
1692 | section, persons holding in good standing any certification |
1693 | under part I of chapter 499, Florida Statutes, as of 11:59 p.m. |
1694 | on the day prior to the effective date of this section shall, as |
1695 | of the effective date of this section, be deemed to be certified |
1696 | in the same capacity in which they were formerly certified. |
1697 | (7) This section shall take effect July 1, 2011. |
1698 | Section 21. (1) All of the statutory powers, duties, and |
1699 | functions, records, personnel, property, and unexpended balances |
1700 | of appropriations, allocations, or other funds for the |
1701 | administration of the boards and professions established within |
1702 | the Division of Medical Quality Assurance as specified in s. |
1703 | 20.43(3)(g), Florida Statutes, shall be transferred by a type |
1704 | two transfer, as defined in s. 20.06(2), Florida Statutes, from |
1705 | the Department of Health to the Department of Business and |
1706 | Professional Regulation. |
1707 | (2) The transfer of regulatory authority of the Division |
1708 | of Medical Quality Assurance provided by this section shall not |
1709 | affect the validity of any judicial or administrative action |
1710 | pending as of 11:59 p.m. on the day before the effective date of |
1711 | this section to which the Department of Health is at that time a |
1712 | party, and the Department of Business and Professional |
1713 | Regulation shall be substituted as a party in interest in any |
1714 | such action. |
1715 | (3) All lawful orders issued by the Department of Health |
1716 | implementing or enforcing or otherwise in regard to any function |
1717 | of the Division of Medical Quality Assurance issued prior to the |
1718 | effective date of this section shall remain in effect and be |
1719 | enforceable after the effective date of this section unless |
1720 | thereafter modified in accordance with law. |
1721 | (4) The rules of the Department of Health relating to the |
1722 | implementation of statutory directives administered by the |
1723 | Division of Medical Quality Assurance that were in effect at |
1724 | 11:59 p.m. on the day prior to the effective date of this |
1725 | section shall become the rules of the Department of Business and |
1726 | Professional Regulation and shall remain in effect until amended |
1727 | or repealed in the manner provided by law. |
1728 | (5) Notwithstanding the transfer of regulatory authority |
1729 | of the Division of Medical Quality Assurance provided by this |
1730 | section, persons and entities holding in good standing any |
1731 | license or permit issued by the Division of Medical Quality |
1732 | Assurance as of 11:59 p.m. on the day prior to the effective |
1733 | date of this section shall, as of the effective date of this |
1734 | section, be deemed to hold in good standing a permit in the same |
1735 | capacity as that for which the permit was formerly issued. |
1736 | (6) Notwithstanding the transfer of regulatory authority |
1737 | of the Division of Medical Quality Assurance provided by this |
1738 | section, persons holding in good standing any certification |
1739 | issued by the Division of Medical Quality Assurance as of 11:59 |
1740 | p.m. on the day prior to the effective date of this section |
1741 | shall, as of the effective date of this section, be deemed to be |
1742 | certified in the same capacity in which they were formerly |
1743 | certified. |
1744 | (7) This section shall take effect July 1, 2011. |
1745 | Section 22. Except as otherwise expressly provided in this |
1746 | act, this act shall take effect July 1, 2010. |