Bill Text: FL H5311 | 2010 | Regular Session | Engrossed


Bill Title: Department of Health [WPSC]

Spectrum: Partisan Bill (Republican 1-0)

Status: (Passed) 2010-05-28 - Approved by Governor; Chapter No. 2010-161; companion bill(s) passed, see HB 5001 (Ch. 2010-152) [H5311 Detail]

Download: Florida-2010-H5311-Engrossed.html
HB 5311
1
A bill to be entitled
2An act relating to the Department of Health; amending s.
320.435, F.S.; revising provisions for administration and
4use of funds in the Administrative Trust Fund and the
5Emergency Medical Services Trust Fund; providing for such
6administration and use under specified provisions;
7amending ss. 318.14, 318.18, and 318.21, F.S.; providing
8that funds collected from disposition of certain motor
9vehicle infractions shall be deposited into the Emergency
10Medical Services Trust Fund; removing provisions for
11deposit of such funds into the Administrative Trust Fund;
12providing for use of the funds; correcting a reference;
13amending ss. 320.131, 327.35, 381.765, and 938.07, F.S.;
14correcting references to the Brain and Spinal Cord Injury
15Program Trust Fund; amending ss. 381.78 and 381.79, F.S.;
16correcting references; amending s. 395.403, F.S., relating
17to reimbursement of trauma centers; revising eligibility
18provisions to remove provisional trauma centers and
19certain hospitals; providing for payments to be made from
20the Emergency Medical Services Trust Fund; removing
21provisions for one-time payments from the Administrative
22Trust Fund; amending s. 395.4036, F.S.; providing for use
23of funds in the Emergency Medical Services Trust Fund for
24verified trauma centers; removing provisions for such use
25of funds in the Administrative Trust Fund; reenacting and
26amending s. 215.5602, F.S., relating to James and Esther
27King Biomedical Research Program; specifying that a
28certain amount of the revenue deposited into the Health
29Care Trust Fund be reserved for tobacco-related and
30cancer-related research; providing for specified amounts
31of revenue to be appropriated to the James and Esther King
32Biomedical Research Program, the William G. "Bill"
33Bankhead, Jr., and David Coley Cancer Research Program,
34and the H. Lee Moffitt Cancer Center and Research
35Institute; deleting obsolete language; reenacting and
36amending s. 381.922, F.S., relating to William G. "Bill"
37Bankhead, Jr., and David Coley Cancer Research Program;
38providing that the program give emphasis to certain goals;
39specifying sources of funding for the program; providing
40for a portion of the funds to be made available to the
41Florida Center for Universal Research to Eradicate
42Disease; deleting obsolete language; amending s. 20.43,
43F.S.; removing a provision authorizing division directors
44in the Department of Health to appoint certain committees;
45prohibiting the department from establishing new programs
46or modifying current programs without legislative
47approval; requiring the department to notify the Governor
48and the Legislature before applying for continuation of or
49new federal or private grants over a specified amount;
50providing for content of the notification; amending s.
51381.0011, F.S.; requiring the department to manage
52emergency preparedness and disaster response functions;
53amending s. 381.006, F.S.; revising the definition of the
54term "group care facility"; revising rulemaking authority;
55amending s. 381.0072, F.S.; revising the definition of the
56term "food service establishment"; authorizing the
57department to advise and consult with other agencies
58concerning the provision of food services; revising
59entities that are exempt from rules developed for manager
60certification; repealing ss. 411.23, 411.231, and 411.232,
61F.S., relating to the Children's Early Investment Program;
62amending ss. 411.01 and 411.224, F.S.; conforming
63provisions to changes made by the act; amending s.
64499.003, F.S.; defining the term "medical convenience kit"
65for purposes of the Florida Drug and Cosmetic Act;
66correcting cross-references; amending s. 499.01, F.S.;
67providing exceptions from requirements for a device
68manufacturer permit; amending s. 499.01212, F.S.;
69exempting wholesale distribution of prescription drugs
70within a medical convenience kit from requirements for the
71wholesaler to provide a pedigree paper if certain
72conditions are met; providing that the exemption does not
73apply to a kit containing certain controlled substances;
74amending s. 509.013, F.S.; revising exclusions to the
75definition of the terms "public lodging establishment" and
76"public food service establishment" to provide for certain
77facilities certified or licensed by the Agency for Health
78Care Administration or the Department of Children and
79Family Services; requiring the department to develop a
80plan to provide tuberculosis services; requiring the
81department to submit the plan to the Governor and
82Legislature by a specified date; providing plan elements;
83transferring and reassigning certain functions and
84responsibilities, including records, personnel, property,
85and unexpended balances of appropriations and other
86resources, from the Department of Health to the Department
87of Business and Professional Regulation by a type two
88transfer; providing for the continued validity of pending
89judicial or administrative actions to which the Department
90of Health is a party; providing for the continued validity
91of lawful orders issued by the Department of Health;
92transferring rules created by the Department of Health to
93the Department of Business and Professional Regulation;
94providing for the continued validity of permits and
95certifications issued by the Department of Health;
96amending s. 381.0403, F.S., deleting provisions relating
97to the program for graduate medical education innovations
98and the graduate medical education committee and report;
99conforming a cross-reference; amending s. 381.4018, F.S.;
100revising provisions for physician workforce assessment and
101development; providing definitions; creating the Physician
102Workforce Advisory Council; providing for membership and
103organization; providing duties of the council; amending
104ss. 458.3192 and 459.0082, F.S.; revising provisions for
105analysis by the department of physician surveys under
106specified provisions; amending s. 458.315; revising
107provisions for issuance by the Board of Medicine of a
108temporary certificate to practice medicine in certain
109areas; creating s. 459.0076, F.S.; providing for issuance
110by the Board of Osteopathic Medicine of a temporary
111certificate to practice osteopathic medicine in certain
112areas; directing the department to conduct an evaluation
113and justification review of its divisions; providing
114review requirements; requiring the department to submit a
115report to the Governor, the Legislature, and the State
116Surgeon General by a specified date; amending s.
117381.00315, F.S.; directing the Department of Health to
118accept funds from counties, municipalities, and certain
119other entities for the purchase of certain products made
120available under a contract with the United States
121Department of Health and Human Services for the
122manufacture and delivery of such products in response to a
123public health emergency; authorizing the department to
124submit a budget amendment requesting additional budget
125authority for the Florida Center for Nursing to make
126certain expenditures; amending ss. 409.9201, 465.0265,
127499.01, 499.01211, 499.01212, 499.03, 499.05, and 794.075,
128F.S.; correcting cross-references; providing effective
129dates.
130
131Be It Enacted by the Legislature of the State of Florida:
132
133 Section 1. Paragraph (a) of subsection (1) and paragraph
134(a) of subsection (14) of section 20.435, Florida Statutes, are
135amended to read:
136 20.435 Department of Health; trust funds.-The following
137trust funds shall be administered by the Department of Health:
138 (1) Administrative Trust Fund.
139 (a) Funds to be credited to and uses of the trust fund
140shall be administered in accordance with s. 215.32 consist of
141regulatory fees such as those pertaining to the
142permitting, and inspection of septic tanks, food
143sewage, Superfund compliance, solid waste
144facilities, mobile home and recreational vehicle park
145inspection, other departmental regulatory and health care
146programs, and indirect earnings from grants. Funds shall be used
147for the purpose of supporting the regulatory activities of the
148department and for other such purposes as may be appropriate and
149shall be expended only pursuant to legislative appropriation or
150an approved amendment to the department's operating budget
151pursuant to the provisions of chapter 216.
152 (14) Emergency Medical Services Trust Fund.
153 (a) Funds to be credited to and uses of the trust fund
154shall be administered in accordance with ss. 318.14, 318.18,
155318.21, 395.403, and 395.4036 and the provisions of parts I and
156II of chapter 401.
157 Section 2. Subsection (5) of section 318.14, Florida
158Statutes, is amended to read:
159 318.14 Noncriminal traffic infractions; exception;
160procedures.-
161 (5) Any person electing to appear before the designated
162official or who is required so to appear shall be deemed to have
163waived his or her right to the civil penalty provisions of s.
164318.18. The official, after a hearing, shall make a
165determination as to whether an infraction has been committed. If
166the commission of an infraction has been proven, the official
167may impose a civil penalty not to exceed $500, except that in
168cases involving unlawful speed in a school zone or involving
169unlawful speed in a construction zone, the civil penalty may not
170exceed $1,000; or require attendance at a driver improvement
171school, or both. If the person is required to appear before the
172designated official pursuant to s. 318.19(1) and is found to
173have committed the infraction, the designated official shall
174impose a civil penalty of $1,000 in addition to any other
175penalties and the person's driver's license shall be suspended
176for 6 months. If the person is required to appear before the
177designated official pursuant to s. 318.19(2) and is found to
178have committed the infraction, the designated official shall
179impose a civil penalty of $500 in addition to any other
180penalties and the person's driver's license shall be suspended
181for 3 months. If the official determines that no infraction has
182been committed, no costs or penalties shall be imposed and any
183costs or penalties that have been paid shall be returned. Moneys
184received from the mandatory civil penalties imposed pursuant to
185this subsection upon persons required to appear before a
186designated official pursuant to s. 318.19(1) or (2) shall be
187remitted to the Department of Revenue and deposited into the
188Department of Health Emergency Medical Services Administrative
189Trust Fund to provide financial support to certified trauma
190centers to assure the availability and accessibility of trauma
191services throughout the state. Funds deposited into the
192Emergency Medical Services Administrative Trust Fund under this
193section shall be allocated as follows:
194 (a) Fifty percent shall be allocated equally among all
195Level I, Level II, and pediatric trauma centers in recognition
196of readiness costs for maintaining trauma services.
197 (b) Fifty percent shall be allocated among Level I, Level
198II, and pediatric trauma centers based on each center's relative
199volume of trauma cases as reported in the Department of Health
200Trauma Registry.
201 Section 3. Paragraph (h) of subsection (3), paragraph (c)
202of subsection (5), and subsection (20) of section 318.18,
203Florida Statutes, are amended to read:
204 318.18 Amount of penalties.-The penalties required for a
205noncriminal disposition pursuant to s. 318.14 or a criminal
206offense listed in s. 318.17 are as follows:
207 (3)
208 (h) A person cited for a second or subsequent conviction
209of speed exceeding the limit by 30 miles per hour and above
210within a 12-month period shall pay a fine that is double the
211amount listed in paragraph (b). For purposes of this paragraph,
212the term "conviction" means a finding of guilt as a result of a
213jury verdict, nonjury trial, or entry of a plea of guilty.
214Moneys received from the increased fine imposed by this
215paragraph shall be remitted to the Department of Revenue and
216deposited into the Department of Health Emergency Medical
217Services Administrative Trust Fund to provide financial support
218to certified trauma centers to assure the availability and
219accessibility of trauma services throughout the state. Funds
220deposited into the Emergency Medical Services Administrative
221Trust Fund under this section shall be allocated as follows:
222 1. Fifty percent shall be allocated equally among all
223Level I, Level II, and pediatric trauma centers in recognition
224of readiness costs for maintaining trauma services.
225 2. Fifty percent shall be allocated among Level I, Level
226II, and pediatric trauma centers based on each center's relative
227volume of trauma cases as reported in the Department of Health
228Trauma Registry.
229 (5)
230 (c) In addition to the penalty under paragraph (a) or
231paragraph (b), $65 for a violation of s. 316.172(1)(a) or (b).
232If the alleged offender is found to have committed the offense,
233the court shall impose the civil penalty under paragraph (a) or
234paragraph (b) plus an additional $65. The additional $65
235collected under this paragraph shall be remitted to the
236Department of Revenue for deposit into the Emergency Medical
237Services Administrative Trust Fund of the Department of Health
238to be used as provided in s. 395.4036.
239 (20) In addition to any other penalty, $65 for a violation
240of s. 316.191, prohibiting racing on highways, or s. 316.192,
241prohibiting reckless driving. The additional $65 collected under
242this subsection shall be remitted to the Department of Revenue
243for deposit into the Emergency Medical Services Administrative
244Trust Fund of the Department of Health to be used as provided in
245s. 395.4036.
246 Section 4. Paragraph (d) of subsection (2) and subsection
247(15) of section 318.21, Florida Statutes, are amended to read:
248 318.21 Disposition of civil penalties by county courts.-
249All civil penalties received by a county court pursuant to the
250provisions of this chapter shall be distributed and paid monthly
251as follows:
252 (2) Of the remainder:
253 (d) Eight and two-tenths percent shall be remitted to the
254Department of Revenue for deposit in the Brain and Spinal Cord
255Injury Program Rehabilitation Trust Fund for the purposes set
256forth in s. 381.79.
257 (15) Of the additional fine assessed under s. 318.18(3)(e)
258for a violation of s. 316.1893, 50 percent of the moneys
259received from the fines shall be appropriated to the Agency for
260Health Care Administration as general revenue to provide an
261enhanced Medicaid payment to nursing homes that serve Medicaid
262recipients with brain and spinal cord injuries. The remaining 50
263percent of the moneys received from the enhanced fine imposed
264under s. 318.18(3)(e) shall be remitted to the Department of
265Revenue and deposited into the Department of Health Emergency
266Medical Services Administrative Trust Fund to provide financial
267support to certified trauma centers in the counties where
268enhanced penalty zones are established to ensure the
269availability and accessibility of trauma services. Funds
270deposited into the Emergency Medical Services Administrative
271Trust Fund under this subsection shall be allocated as follows:
272 (a) Fifty percent shall be allocated equally among all
273Level I, Level II, and pediatric trauma centers in recognition
274of readiness costs for maintaining trauma services.
275 (b) Fifty percent shall be allocated among Level I, Level
276II, and pediatric trauma centers based on each center's relative
277volume of trauma cases as reported in the Department of Health
278Trauma Registry.
279 Section 5. Subsection (2) of section 320.131, Florida
280Statutes, is amended to read:
281 320.131 Temporary tags.-
282 (2) The department is authorized to sell temporary tags,
283in addition to those listed above, to their agents and where
284need is demonstrated by a consumer complainant. The fee shall be
285$2 each. One dollar from each tag sold shall be deposited into
286the Brain and Spinal Cord Injury Program Rehabilitation Trust
287Fund, with the remaining proceeds being deposited into the
288Highway Safety Operating Trust Fund. Agents of the department
289shall sell temporary tags for $2 each and shall charge the
290service charge authorized by s. 320.04 per transaction,
291regardless of the quantity sold. Requests for purchase of
292temporary tags to the department or its agents shall be made,
293where applicable, on letterhead stationery and notarized. Except
294as specifically provided otherwise, a temporary tag shall be
295valid for 30 days, and no more than two shall be issued to the
296same person for the same vehicle.
297 Section 6. Subsection (9) of section 327.35, Florida
298Statutes, is amended to read:
299 327.35 Boating under the influence; penalties; "designated
300drivers".-
301 (9) Notwithstanding any other provision of this section,
302for any person convicted of a violation of subsection (1), in
303addition to the fines set forth in subsections (2) and (4), an
304additional fine of $60 shall be assessed and collected in the
305same manner as the fines set forth in subsections (2) and (4).
306All fines collected under this subsection shall be remitted by
307the clerk of the court to the Department of Revenue for deposit
308into the Brain and Spinal Cord Injury Program Rehabilitation
309Trust Fund and used for the purposes set forth in
310after 5 percent is deducted therefrom by the clerk of
311for administrative costs.
312 Section 7. Subsection (2) of section 381.765, Florida
313Statutes, is amended to read:
314 381.765 Retention of title to and disposal of equipment.-
315 (2) The department may offer for sale any surplus items
316acquired in operating the brain and spinal cord injury program
317when they are no longer necessary or exchange them for necessary
318items that may be used to greater advantage. When any such
319surplus equipment is sold or exchanged, a receipt for the
320equipment shall be taken from the purchaser showing the
321consideration given for such equipment and forwarded to the
322Chief Financial Officer, and any funds received by the brain and
323spinal cord injury program pursuant to any such transaction
324shall be deposited in the Brain and Spinal Cord Injury Program
325Rehabilitation Trust Fund and shall be available for expenditure
326for any purpose consistent with ss. 381.739-381.79 this part.
327 Section 8. Subsection (7) of section 381.78, Florida
328Statutes, is amended to read:
329 381.78 Advisory council on brain and spinal cord
330injuries.-
331 (7) A member of the advisory council may be removed from
332office by the State Surgeon General for malfeasance,
333misfeasance, neglect of duty, incompetence, or permanent
334inability to perform official duties or for pleading nolo
335contendere to, or being found guilty of, a crime. Malfeasance
336includes, but is not limited to, a violation of any specific
337prohibition within ss. 381.739-381.79 this part.
338 Section 9. Subsection (6) of section 381.79, Florida
339Statutes, is amended to read:
340 381.79 Brain and Spinal Cord Injury Program Trust Fund.-
341 (6) The department may accept, deposit into the trust
342fund, and use for carrying out the purposes of ss. 381.739-
343381.79 this part gifts made unconditionally by will or
344otherwise. Any gift made under conditions that, in the judgment
345of the department, are proper and consistent with this section,
346the laws of the United States, and the laws of this state may be
347accepted and shall be held, invested, reinvested, and used in
348accordance with the conditions of the gift.
349 Section 10. Subsections (1) and (2) of section 395.403,
350Florida Statutes, are amended to read:
351 395.403 Reimbursement of trauma centers.-
352 (1) All provisional trauma centers and trauma centers
353shall be considered eligible to receive state funding when state
354funds are specifically appropriated for state-sponsored trauma
355centers in the General Appropriations Act. Effective July 1,
3562010 2004, the department shall make one-time payments from the
357Emergency Medical Services Administrative Trust Fund under s.
35820.435 to the trauma centers and a hospital with a pending
359application for a Level I trauma center in recognition of the
360capital investment made by the hospital to establish the trauma
361service. Payments shall be in equal amounts for the trauma
362centers approved by the department as of July 1 of the fiscal
363year in which funding is appropriated, with lesser amounts for
364the hospital with an application pending for a Level I trauma
365center at the department as of April 1, 2004. In the event a
366trauma center does not maintain its status as a trauma center
367for any state fiscal year in which such funding is appropriated,
368the provisional trauma center or trauma center shall repay the
369state for the portion of the year during which it was not a
370trauma center.
371 (2) Provisional trauma centers and Trauma centers eligible
372to receive distributions from the Emergency Medical Services
373Administrative Trust Fund under s. 20.435 in accordance with
374subsection (1) may request that such funds be used as
375intergovernmental transfer funds in the Medicaid program.
376 Section 11. Subsections (1) and (2) of section 395.4036,
377Florida Statutes, are amended to read:
378 395.4036 Trauma payments.-
379 (1) Recognizing the Legislature's stated intent to provide
380financial support to the current verified trauma centers and to
381provide incentives for the establishment of additional trauma
382centers as part of a system of state-sponsored trauma centers,
383the department shall utilize funds collected under s. 318.18 and
384deposited into the Emergency Medical Services Administrative
385Trust Fund of the department to ensure the availability and
386accessibility of trauma services throughout the state as
387provided in this subsection.
388 (a) Funds collected under s. 318.18(15) shall be
389distributed as follows:
390 1. Twenty percent of the total funds collected during the
391state fiscal year shall be distributed to verified trauma
392centers that have a local funding contribution as of December
39331. Distribution of funds under this subparagraph shall be based
394on trauma caseload volume for the most recent calendar year
395available.
396 2. Forty percent of the total funds collected shall be
397distributed to verified trauma centers based on trauma caseload
398volume for the most recent calendar year available. The
399determination of caseload volume for distribution of funds under
400this subparagraph shall be based on the department's Trauma
401Registry data.
402 3. Forty percent of the total funds collected shall be
403distributed to verified trauma centers based on severity of
404trauma patients for the most recent calendar year available. The
405determination of severity for distribution of funds under this
406subparagraph shall be based on the department's International
407Classification Injury Severity Scores or another statistically
408valid and scientifically accepted method of stratifying a trauma
409patient's severity of injury, risk of mortality, and resource
410consumption as adopted by the department by rule, weighted based
411on the costs associated with and incurred by the trauma center
412in treating trauma patients. The weighting of scores shall be
413established by the department by rule.
414 (b) Funds collected under s. 318.18(5)(c) and (19) shall
415be distributed as follows:
416 1. Thirty percent of the total funds collected shall be
417distributed to Level II trauma centers operated by a public
418hospital governed by an elected board of directors as of
419December 31, 2008.
420 2. Thirty-five percent of the total funds collected shall
421be distributed to verified trauma centers based on trauma
422caseload volume for the most recent calendar year available. The
423determination of caseload volume for distribution of funds under
424this subparagraph shall be based on the department's Trauma
425Registry data.
426 3. Thirty-five percent of the total funds collected shall
427be distributed to verified trauma centers based on severity of
428trauma patients for the most recent calendar year available. The
429determination of severity for distribution of funds under this
430subparagraph shall be based on the department's International
431Classification Injury Severity Scores or another statistically
432valid and scientifically accepted method of stratifying a trauma
433patient's severity of injury, risk of mortality, and resource
434consumption as adopted by the department by rule, weighted based
435on the costs associated with and incurred by the trauma center
436in treating trauma patients. The weighting of scores shall be
437established by the department by rule.
438 (2) Funds deposited in the department's Emergency Medical
439Services Administrative Trust Fund for verified trauma centers
440may be used to maximize the receipt of federal funds that may be
441available for such trauma centers. Notwithstanding this section
442and s. 318.14, distributions to trauma centers may be adjusted
443in a manner to ensure that total payments to trauma centers
444represent the same proportional allocation as set forth in this
445section and s. 318.14. For purposes of this section and s.
446318.14, total funds distributed to trauma centers may include
447revenue from the Emergency Medical Services Administrative Trust
448Fund and federal funds for which revenue from the Administrative
449Trust Fund is used to meet state or local matching requirements.
450Funds collected under ss. 318.14 and 318.18 and deposited in the
451Emergency Medical Services Administrative Trust Fund of the
452department shall be distributed to trauma centers on a quarterly
453basis using the most recent calendar year data available. Such
454data shall not be used for more than four quarterly
455distributions unless there are extenuating circumstances as
456determined by the department, in which case the most recent
457calendar year data available shall continue to be used and
458appropriate adjustments shall be made as soon as the more recent
459data becomes available.
460 Section 12. Section 938.07, Florida Statutes, is amended to
461read:
462 938.07 Driving or boating under the influence.-
463Notwithstanding any other provision of s. 316.193 or s. 327.35,
464a court cost of $135 shall be added to any fine imposed pursuant
465to s. 316.193 or s. 327.35. The clerks shall remit the funds to
466the Department of Revenue, $25 of which shall be deposited in
467the Emergency Medical Services Trust Fund, $50 shall be
468deposited in the Operating Trust Fund of the Department of Law
469Enforcement to be used for operational expenses in conducting
470the statewide criminal analysis laboratory system established in
471s. 943.32, and $60 shall be deposited in the Brain and Spinal
472Cord Injury Program Rehabilitation Trust Fund created in s.
473381.79.
474 Section 13. Section 215.5602, Florida Statutes, is
475reenacted and amended to read:
476 215.5602 James and Esther King Biomedical Research
477Program.-
478 (1) There is established within the Department of Health
479the James and Esther King Biomedical Research Program funded by
480the proceeds of the Lawton Chiles Endowment Fund pursuant to s.
481215.5601. The purpose of the James and Esther King Biomedical
482Research Program is to provide an annual and perpetual source of
483funding in order to support research initiatives that address
484the health care problems of Floridians in the areas of tobacco-
485related cancer, cardiovascular disease, stroke, and pulmonary
486disease. The long-term goals of the program are to:
487 (a) Improve the health of Floridians by researching better
488prevention, diagnoses, treatments, and cures for cancer,
489cardiovascular disease, stroke, and pulmonary disease.
490 (b) Expand the foundation of biomedical knowledge relating
491to the prevention, diagnosis, treatment, and cure of diseases
492related to tobacco use, including cancer, cardiovascular
493disease, stroke, and pulmonary disease.
494 (c) Improve the quality of the state's academic health
495centers by bringing the advances of biomedical research into the
496training of physicians and other health care providers.
497 (d) Increase the state's per capita funding for research
498by undertaking new initiatives in public health and biomedical
499research that will attract additional funding from outside the
500state.
501 (e) Stimulate economic activity in the state in areas
502related to biomedical research, such as the research and
503production of pharmaceuticals, biotechnology, and medical
504devices.
505 (2) Funds appropriated for the James and Esther King
506Biomedical Research Program shall be used exclusively for the
507award of grants and fellowships as established in this section;
508for research relating to the prevention, diagnosis, treatment,
509and cure of diseases related to tobacco use, including cancer,
510cardiovascular disease, stroke, and pulmonary disease; and for
511expenses incurred in the administration of this section.
512Priority shall be granted to research designed to prevent or
513cure disease.
514 (3) There is created within the Department of Health the
515Biomedical Research Advisory Council.
516 (a) The council shall consist of 11 members, including:
517the chief executive officer of the Florida Division of the
518American Cancer Society, or a designee; the chief executive
519officer of the Florida/Puerto Rico Affiliate of the American
520Heart Association, or a designee; and the chief executive
521officer of the American Lung Association of Florida, or a
522designee. The remaining 8 members of the council shall be
523appointed as follows:
524 1. The Governor shall appoint four members, two members
525with expertise in the field of biomedical research, one member
526from a research university in the state, and one member
527representing the general population of the state.
528 2. The President of the Senate shall appoint two members,
529one member with expertise in the field of behavioral or social
530research and one representative from a cancer program approved
531by the American College of Surgeons.
532 3. The Speaker of the House of Representatives shall
533appoint two members, one member from a professional medical
534organization and one representative from a cancer program
535approved by the American College of Surgeons.
536
537In making these appointments, the Governor, the President of the
538Senate, and the Speaker of the House of Representatives shall
539select primarily, but not exclusively, Floridians with
540biomedical and lay expertise in the general areas of cancer,
541cardiovascular disease, stroke, and pulmonary disease. The
542appointments shall be for a 3-year term and shall reflect the
543diversity of the state's population. An appointed member may not
544serve more than two consecutive terms.
545 (b) The council shall adopt internal organizational
546procedures as necessary for its efficient organization.
547 (c) The department shall provide such staff, information,
548and other assistance as is reasonably necessary to assist the
549council in carrying out its responsibilities.
550 (d) Members of the council shall serve without
551compensation, but may receive reimbursement as provided in s.
552112.061 for travel and other necessary expenses incurred in the
553performance of their official duties.
554 (4) The council shall advise the State Surgeon General as
555to the direction and scope of the biomedical research program.
556The responsibilities of the council may include, but are not
557limited to:
558 (a) Providing advice on program priorities and emphases.
559 (b) Providing advice on the overall program budget.
560 (c) Participating in periodic program evaluation.
561 (d) Assisting in the development of guidelines to ensure
562fairness, neutrality, and adherence to the principles of merit
563and quality in the conduct of the program.
564 (e) Assisting in the development of appropriate linkages
565to nonacademic entities, such as voluntary organizations, health
566care delivery institutions, industry, government agencies, and
567public officials.
568 (f) Developing criteria and standards for the award of
569research grants.
570 (g) Developing administrative procedures relating to
571solicitation, review, and award of research grants and
572fellowships, to ensure an impartial, high-quality peer review
573system.
574 (h) Developing and supervising research peer review
575panels.
576 (i) Reviewing reports of peer review panels and making
577recommendations for research grants and fellowships.
578 (j) Developing and providing oversight regarding
579mechanisms for the dissemination of research results.
580 (5)(a) Applications for biomedical research funding under
581the program may be submitted from any university or established
582research institute in the state. All qualified investigators in
583the state, regardless of institution affiliation, shall have
584equal access and opportunity to compete for the research
585funding.
586 (b) Grants and fellowships shall be awarded by the State
587Surgeon General, after consultation with the council, on the
588basis of scientific merit, as determined by an open competitive
589peer review process that ensures objectivity, consistency, and
590high quality. The following types of applications shall be
591considered for funding:
592 1. Investigator-initiated research grants.
593 2. Institutional research grants.
594 3. Predoctoral and postdoctoral research fellowships.
595 (6) To ensure that all proposals for research funding are
596appropriate and are evaluated fairly on the basis of scientific
597merit, the State Surgeon General, in consultation with the
598council, shall appoint a peer review panel of independent,
599scientifically qualified individuals to review the scientific
600content of each proposal and establish its scientific priority
601score. The priority scores shall be forwarded to the council and
602must be considered in determining which proposals shall be
603recommended for funding.
604 (7) The council and the peer review panel shall establish
605and follow rigorous guidelines for ethical conduct and adhere to
606a strict policy with regard to conflict of interest. A member of
607the council or panel may not participate in any discussion or
608decision with respect to a research proposal by any firm,
609entity, or agency with which the member is associated as a
610member of the governing body or as an employee, or with which
611the member has entered into a contractual arrangement. Meetings
612of the council and the peer review panels shall be subject to
613the provisions of chapter 119, s. 286.011, and s. 24, Art. I of
614the State Constitution.
615 (8) The department may contract on a competitive-bid basis
616with an appropriate entity to administer the program.
617Administrative expenses may not exceed 15 percent of the total
618funds available to the program in any given year.
619 (9) The department, after consultation with the council,
620may adopt rules as necessary to implement this section.
621 (10) The council shall submit an annual progress report on
622the state of biomedical research in this state to the Florida
623Center for Universal Research to Eradicate Disease and to the
624Governor, the State Surgeon General, the President of the
625Senate, and the Speaker of the House of Representatives by
626February 1. The report must include:
627 (a) A list of research projects supported by grants or
628fellowships awarded under the program.
629 (b) A list of recipients of program grants or fellowships.
630 (c) A list of publications in peer reviewed journals
631involving research supported by grants or fellowships awarded
632under the program.
633 (d) The total amount of biomedical research funding
634currently flowing into the state.
635 (e) New grants for biomedical research which were funded
636based on research supported by grants or fellowships awarded
637under the program.
638 (f) Progress in the prevention, diagnosis, treatment, and
639cure of diseases related to tobacco use, including cancer,
640cardiovascular disease, stroke, and pulmonary disease.
641 (11) The council shall award grants for cancer research
642through the William G. "Bill" Bankhead, Jr., and David Coley
643Cancer Research Program created in s. 381.922.
644 (12) From funds appropriated to accomplish the goals of
645this section, up to $250,000 shall be available for the
646operating costs of the Florida Center for Universal Research to
647Eradicate Disease.
648 (a) Beginning in the 2010-2011 2009-2010 fiscal year and
649thereafter, $50 million from 5 percent of the revenue deposited
650into the Health Care Trust Fund pursuant to ss. 210.011(9) and
651210.276(7) shall be reserved for research of tobacco-related or
652cancer-related illnesses; however, the sum of the revenue
653reserved pursuant to ss. 210.011(9) and 210.276(7) may not
654exceed $50 million in any fiscal year. Of the revenue deposited
655in the Health Care Trust Fund pursuant to this section, $50
656million shall be transferred to the Biomedical Research Trust
657Fund within the Department of Health. Subject to annual
658appropriations in the General Appropriations Act, $20 million
659shall be appropriated to the James and Esther King Biomedical
660Research Program, $20 million shall be appropriated to the
661William G. "Bill" Bankhead, Jr., and David Coley Cancer Research
662Program created under s. 381.922, and $10 million shall be
663appropriated to the H. Lee Moffitt Cancer Center and Research
664Institute established under s. 1004.43.
665 (b) In the 2009-2010 fiscal year, 2.5 percent, not to
666exceed $25 million, of the revenue deposited into the Health
667Care Trust Fund pursuant to this subsection shall be transferred
668to the Biomedical Research Trust Fund within the Department of
669Health for the James and Esther King Biomedical Research
670Program.
671 (13) By June 1, 2009, the Division of Statutory Revision
672of the Office of Legislative Services shall certify to the
673President of the Senate and the Speaker of the House of
674Representatives the language and statutory citation of this
675section, which is scheduled to expire January 1, 2011.
676 (14) The Legislature shall review the performance, the
677outcomes, and the financial management of the James and Esther
678King Biomedical Research Program during the 2010 Regular Session
679of the Legislature and shall determine the most appropriate
680funding source and means of funding the program based on its
681review.
682 (15) This section expires January 1, 2011, unless reviewed
683and reenacted by the Legislature before that date.
684 Section 14. Section 381.922, Florida Statutes, is
685reenacted and amended to read:
686 381.922 William G. "Bill" Bankhead, Jr., and David Coley
687Cancer Research Program.-
688 (1) The William G. "Bill" Bankhead, Jr., and David Coley
689Cancer Research Program, which may be otherwise cited as the
690"Bankhead-Coley Program," is created within the Department of
691Health. The purpose of the program shall be to advance progress
692towards cures for cancer through grants awarded through a peer-
693reviewed, competitive process.
694 (2) The program shall provide grants for cancer research
695to further the search for cures for cancer.
696 (a) Emphasis shall be given to the following goals
697enumerated in s. 381.921, as those goals support the advancement
698of such cures:
699 1. Efforts to significantly expand cancer research
700capacity in the state by:
701 a. Identifying ways to attract new research talent and
702attendant national grant-producing researchers to cancer
703research facilities in this state;
704 b. Implementing a peer-reviewed, competitive process to
705identify and fund the best proposals to expand cancer research
706institutes in this state;
707 c. Funding through available resources for those proposals
708that demonstrate the greatest opportunity to attract federal
709research grants and private financial support;
710 d. Encouraging the employment of bioinformatics in order
711to create a cancer informatics infrastructure that enhances
712information and resource exchange and integration through
713researchers working in diverse disciplines, to facilitate the
714full spectrum of cancer investigations;
715 e. Facilitating the technical coordination, business
716development, and support of intellectual property as it relates
717to the advancement of cancer research; and
718 f. Aiding in other multidisciplinary research-support
719activities as they inure to the advancement of cancer research.
720 2. Efforts to improve both research and treatment through
721greater participation in clinical trials networks by:
722 a. Identifying ways to increase adult enrollment in cancer
723clinical trials;
724 b. Supporting public and private professional education
725programs designed to increase the awareness and knowledge about
726cancer clinical trials;
727 c. Providing tools to cancer patients and community-based
728oncologists to aid in the identification of cancer clinical
729trials available in the state; and
730 d. Creating opportunities for the state's academic cancer
731centers to collaborate with community-based oncologists in
732cancer clinical trials networks.
733 3. Efforts to reduce the impact of cancer on disparate
734groups by:
735 a. Identifying those cancers that disproportionately
736impact certain demographic groups; and
737 b. Building collaborations designed to reduce health
738disparities as they relate to cancer.
739 (b) Preference may be given to grant proposals that foster
740collaborations among institutions, researchers, and community
741practitioners, as such proposals support the advancement of
742cures through basic or applied research, including clinical
743trials involving cancer patients and related networks.
744 (3)(a) Applications for funding for cancer research may be
745submitted by any university or established research institute in
746the state. All qualified investigators in the state, regardless
747of institutional affiliation, shall have equal access and
748opportunity to compete for the research funding. Collaborative
749proposals, including those that advance the program's goals
750enumerated in subsection (2), may be given preference. Grants
751shall be awarded by the State Surgeon General, after
752consultation with the Biomedical Research Advisory Council, on
753the basis of scientific merit, as determined by an open,
754competitive peer review process that ensures objectivity,
755consistency, and high quality. The following types of
756applications shall be considered for funding:
757 1. Investigator-initiated research grants.
758 2. Institutional research grants.
759 3. Collaborative research grants, including those that
760advance the finding of cures through basic or applied research.
761 (b) In order to ensure that all proposals for research
762funding are appropriate and are evaluated fairly on the basis of
763scientific merit, the State Surgeon General, in consultation
764with the council, shall appoint a peer review panel of
765independent, scientifically qualified individuals to review the
766scientific content of each proposal and establish its priority
767score. The priority scores shall be forwarded to the council and
768must be considered in determining which proposals shall be
769recommended for funding.
770 (c) The council and the peer review panel shall establish
771and follow rigorous guidelines for ethical conduct and adhere to
772a strict policy with regard to conflicts of interest. A member
773of the council or panel may not participate in any discussion or
774decision with respect to a research proposal by any firm,
775entity, or agency with which the member is associated as a
776member of the governing body or as an employee or with which the
777member has entered into a contractual arrangement. Meetings of
778the council and the peer review panels are subject to chapter
779119, s. 286.011, and s. 24, Art. I of the State Constitution.
780 (4) By December 15 of each year, the Department of Health
781shall submit to the Governor, the President of the Senate, and
782the Speaker of the House of Representatives a report indicating
783progress towards the program's mission and making
784recommendations that further its purpose.
785 (5) The William G. "Bill" Bankhead, Jr., and David Coley
786Cancer Research Program is funded pursuant to s. 215.5602(12).
787Funds appropriated for the William G. "Bill" Bankhead, Jr., and
788David Coley Cancer Research Program shall be distributed
789pursuant to this section to provide grants to researchers
790seeking cures for cancer and cancer-related illnesses, with
791emphasis given to the goals enumerated in this section s.
792381.921. From the total funds appropriated, an amount of up to
79310 percent may be used for administrative expenses. From funds
794appropriated to accomplish the goals of this section, up to
795$250,000 shall be available for the operating costs of the
796Florida Center for Universal Research to Eradicate Disease. In
797the 2009-2010 fiscal year, 2.5 percent, not to exceed $25
798million, of the revenue deposited into the Health Care Trust
799Fund pursuant to s. 215.5602(12)(a) shall be transferred to the
800Biomedical Research Trust Fund within the Department of Health
801for the William G. "Bill" Bankhead, Jr., and David Coley Cancer
802Research Program.
803 (6) By June 1, 2009, the Division of Statutory Revision of
804the Office of Legislative Services shall certify to the
805President of the Senate and the Speaker of the House of
806Representatives the language and statutory citation of this
807section, which is scheduled to expire January 1, 2011.
808 (7) The Legislature shall review the performance, the
809outcomes, and the financial management of the William G. "Bill"
810Bankhead, Jr., and David Coley Cancer Research Program during
811the 2010 Regular Session of the Legislature and shall determine
812the most appropriate funding source and means of funding the
813program based on its review.
814 (8) This section expires January 1, 2011, unless reviewed
815and reenacted by the Legislature before that date.
816 Section 15. Subsection (6) of section 20.43, Florida
817Statutes, is amended, and subsection (10) is added to that
818section, to read:
819 20.43 Department of Health.-There is created a Department
820of Health.
821 (6) The State Surgeon General is and division directors
822are authorized to appoint ad hoc advisory committees as
823necessary. The issue or problem that the ad hoc committee shall
824address, and the timeframe within which the committee is to
825complete its work, shall be specified at the time the committee
826is appointed. Ad hoc advisory committees shall include
827representatives of groups or entities affected by the issue or
828problem that the committee is asked to examine. Members of ad
829hoc advisory committees shall receive no compensation, but may,
830within existing departmental resources, receive reimbursement
831for travel expenses as provided in s. 112.061.
832 (10)(a) Beginning in fiscal year 2010-2011, the department
833shall initiate or commence new programs only when the
834Legislative Budget Commission or the Legislature expressly
835authorizes the department to do so.
836 (b) Beginning in fiscal year 2010-2011, before applying
837for any continuation of or new federal or private grants that
838are for an amount of $50,000 or greater, the department shall
839provide written notification to the Governor, the President of
840the Senate, and the Speaker of the House of Representatives. The
841notification must include detailed information about the purpose
842of the grant, the intended use of the funds, and the number of
843full-time permanent or temporary employees needed to administer
844the program funded by the grant.
845 Section 16. Subsection (14) of section 381.0011, Florida
846Statutes, is renumbered as subsection (15), and a new subsection
847(14) is added to that section, to read:
848 381.0011 Duties and powers of the Department of Health.-It
849is the duty of the Department of Health to:
850 (14) Manage and coordinate emergency preparedness and
851disaster response functions to: investigate and control the
852spread of disease; coordinate the availability and staffing of
853special needs shelters; support patient evacuation; ensure the
854safety of food and drugs; provide critical incident stress
855debriefing; and provide surveillance and control of
856radiological, chemical, biological, and other environmental
857hazards.
858 Section 17. Subsection (16) of section 381.006, Florida
859Statutes, is amended to read:
860 381.006 Environmental health.-The department shall conduct
861an environmental health program as part of fulfilling the
862state's public health mission. The purpose of this program is to
863detect and prevent disease caused by natural and manmade factors
864in the environment. The environmental health program shall
865include, but not be limited to:
866 (16) A group-care-facilities function. As used in this
867subsection, the term, where a "group care facility" means any
868public or private school, assisted living facility, adult
869family-care home, adult day care center, short-term residential
870treatment center, residential treatment facility, home for
871special services, transitional living facility, crisis
872stabilization unit, hospice, prescribed pediatric extended care
873center, intermediate care facility for persons with
874developmental disabilities, or boarding school housing, building
875or buildings, section of a building, or distinct part of a
876building or other place, whether operated for profit or not,
877which undertakes, through its ownership or management, to
878provide one or more personal services, care, protection, and
879supervision to persons who require such services and who are not
880related to the owner or administrator. The department may adopt
881rules necessary to protect the health and safety of residents,
882staff, and patrons of group care facilities. Rules related to
883public and private schools shall be developed by, such as child
884care facilities, family day care homes, assisted living
885facilities, adult day care centers, adult family care homes,
886hospices, residential treatment facilities, crisis stabilization
887units, pediatric extended care centers, intermediate care
888facilities for the developmentally disabled, group care homes,
889and, jointly with the Department of Education in consultation
890with the department, private and public schools. These Rules
891adopted under this subsection may include definitions of terms;
892provisions relating to operation and maintenance of facilities,
893buildings, grounds, equipment, furnishings, and occupant-space
894requirements; lighting; heating, cooling, and ventilation; food
895service; water supply and plumbing; sewage; sanitary facilities;
896insect and rodent control; garbage; safety; personnel health,
897hygiene, and work practices; and other matters the department
898finds are appropriate or necessary to protect the safety and
899health of the residents, staff, students, faculty, or patrons.
900The department may not adopt rules that conflict with rules
901adopted by the licensing or certifying agency. The department
902may enter and inspect at reasonable hours to determine
903compliance with applicable statutes or rules. In addition to any
904sanctions that the department may impose for violations of rules
905adopted under this section, the department shall also report
906such violations to any agency responsible for licensing or
907certifying the group care facility. The licensing or certifying
908agency may also impose any sanction based solely on the findings
909of the department.
910
911The department may adopt rules to carry out the provisions of
912this section.
913 Section 18. Subsections (1), (2), (3), and (6) of section
914381.0072, Florida Statutes, are amended to read:
915 381.0072 Food service protection.-It shall be the duty of
916the Department of Health to adopt and enforce sanitation rules
917consistent with law to ensure the protection of the public from
918food-borne illness. These rules shall provide the standards and
919requirements for the storage, preparation, serving, or display
920of food in food service establishments as defined in this
921section and which are not permitted or licensed under chapter
922500 or chapter 509.
923 (1) DEFINITIONS.-As used in this section, the term:
924 (a) "Department" means the Department of Health or its
925representative county health department.
926 (b) "Food service establishment" means detention
927facilities, public or private schools, migrant labor camps,
928assisted living facilities, adult family-care homes, adult day
929care centers, short-term residential treatment centers,
930residential treatment facilities, homes for special services,
931transitional living facilities, crisis stabilization units,
932hospices, prescribed pediatric extended care centers,
933intermediate care facilities for persons with developmental
934disabilities, boarding schools, civic or fraternal
935organizations, bars and lounges, vending machines that dispense
936potentially hazardous foods at facilities expressly named in
937this paragraph, and facilities used as temporary food events or
938mobile food units at any facility expressly named any facility,
939as described in this paragraph, where food is prepared and
940intended for individual portion service, including and includes
941the site at which individual portions are provided,. The term
942includes any such facility regardless of whether consumption is
943on or off the premises and regardless of whether there is a
944charge for the food. The term includes detention facilities,
945child care facilities, schools, institutions, civic or fraternal
946organizations, bars and lounges and facilities used at temporary
947food events, mobile food units, and vending machines at any
948facility regulated under this section. The term does not include
949any entity not expressly named in this paragraph private homes
950where food is prepared or served for individual family
951consumption; nor does the term include churches, synagogues, or
952other not-for-profit religious organizations as long as these
953organizations serve only their members and guests and do not
954advertise food or drink for public consumption, or any facility
955or establishment permitted or licensed under chapter 500 or
956chapter 509; nor does the term include any theater, if the
957primary use is as a theater and if patron service is limited to
958food items customarily served to the admittees of theaters; nor
959does the term include a research and development test kitchen
960limited to the use of employees and which is not open to the
961general public.
962 (c) "Operator" means the owner, operator, keeper,
963proprietor, lessee, manager, assistant manager, agent, or
964employee of a food service establishment.
965 (2) DUTIES.-
966 (a) The department may advise and consult with the Agency
967for Health Care Administration, the Department of Business and
968Professional Regulation, the Department of Agriculture and
969Consumer Services, and the Department of Children and Family
970Services concerning procedures related to the storage,
971preparation, serving, or display of food at any building,
972structure, or facility not expressly included in this section
973that is inspected, licensed, or regulated by those agencies.
974 (b)(a) The department shall adopt rules, including
975definitions of terms which are consistent with law prescribing
976minimum sanitation standards and manager certification
977requirements as prescribed in s. 509.039, and which shall be
978enforced in food service establishments as defined in this
979section. The sanitation standards must address the construction,
980operation, and maintenance of the establishment; lighting,
981ventilation, laundry rooms, lockers, use and storage of toxic
982materials and cleaning compounds, and first-aid supplies; plan
983review; design, construction, installation, location,
984maintenance, sanitation, and storage of food equipment and
985utensils; employee training, health, hygiene, and work
986practices; food supplies, preparation, storage, transportation,
987and service, including access to the areas where food is stored
988or prepared; and sanitary facilities and controls, including
989water supply and sewage disposal; plumbing and toilet
990facilities; garbage and refuse collection, storage, and
991disposal; and vermin control. Public and private schools, if the
992food service is operated by school employees,; hospitals
993licensed under chapter 395; nursing homes licensed under part II
994of chapter 400; child care facilities as defined in s. 402.301;
995residential facilities colocated with a nursing home or
996hospital, if all food is prepared in a central kitchen that
997complies with nursing or hospital regulations; and bars and
998lounges, civic organizations, and any other facility that is not
999regulated under this section as defined by department rule, are
1000exempt from the rules developed for manager certification. The
1001department shall administer a comprehensive inspection,
1002monitoring, and sampling program to ensure such standards are
1003maintained. With respect to food service establishments
1004permitted or licensed under chapter 500 or chapter 509, the
1005department shall assist the Division of Hotels and Restaurants
1006of the Department of Business and Professional Regulation and
1007the Department of Agriculture and Consumer Services with
1008rulemaking by providing technical information.
1009 (c)(b) The department shall carry out all provisions of
1010this chapter and all other applicable laws and rules relating to
1011the inspection or regulation of food service establishments as
1012defined in this section, for the purpose of safeguarding the
1013public's health, safety, and welfare.
1014 (d)(c) The department shall inspect each food service
1015establishment as often as necessary to ensure compliance with
1016applicable laws and rules. The department shall have the right
1017of entry and access to these food service establishments at any
1018reasonable time. In inspecting food service establishments as
1019provided under this section, the department shall provide each
1020inspected establishment with the food recovery brochure
1021developed under s. 570.0725.
1022 (e)(d) The department or other appropriate regulatory
1023entity may inspect theaters exempted in subsection (1) to ensure
1024compliance with applicable laws and rules pertaining to minimum
1025sanitation standards. A fee for inspection shall be prescribed
1026by rule, but the aggregate amount charged per year per theater
1027establishment shall not exceed $300, regardless of the entity
1028providing the inspection.
1029 (3) LICENSES REQUIRED.-
1030 (a) Licenses; annual renewals.-Each food service
1031establishment regulated under this section shall obtain a
1032license from the department annually. Food service establishment
1033licenses shall expire annually and are not transferable from one
1034place or individual to another. However, those facilities
1035licensed by the department's Office of Licensure and
1036Certification, the Child Care Services Program Office, or the
1037Agency for Persons with Disabilities are exempt from this
1038subsection. It shall be a misdemeanor of the second degree,
1039punishable as provided in s. 381.0061, s. 775.082, or s.
1040775.083, for such an establishment to operate without this
1041license. The department may refuse a license, or a renewal
1042thereof, to any establishment that is not constructed or
1043maintained in accordance with law and with the rules of the
1044department. Annual application for renewal is not required.
1045 (b) Application for license.-Each person who plans to open
1046a food service establishment regulated under this section and
1047not regulated under chapter 500 or chapter 509 shall apply for
1048and receive a license prior to the commencement of operation.
1049 (6) IMMINENT DANGERS; STOP-SALE ORDERS.-
1050 (a) In the course of epidemiological investigations or for
1051those establishments regulated by the department under this
1052chapter, the department, to protect the public from food that is
1053unwholesome or otherwise unfit for human consumption, may
1054examine, sample, seize, and stop the sale or use of food to
1055determine its condition. The department may stop the sale and
1056supervise the proper destruction of food when the State Health
1057Officer or his or her designee determines that such food
1058represents a threat to the public health.
1059 (b) The department may determine that a food service
1060establishment regulated under this section is an imminent danger
1061to the public health and require its immediate closure when such
1062establishment fails to comply with applicable sanitary and
1063safety standards and, because of such failure, presents an
1064imminent threat to the public's health, safety, and welfare. The
1065department may accept inspection results from state and local
1066building and firesafety officials and other regulatory agencies
1067as justification for such actions. Any facility so deemed and
1068closed shall remain closed until allowed by the department or by
1069judicial order to reopen.
1070 Section 19. Sections 411.23, 411.231, and 411.232, Florida
1071Statutes, are repealed.
1072 Section 20. Paragraph (d) of subsection (5) of section
1073411.01, Florida Statutes, is amended to read:
1074 411.01 School readiness programs; early learning
1075coalitions.-
1076 (5) CREATION OF EARLY LEARNING COALITIONS.-
1077 (d) Implementation.-
1078 1. An early learning coalition may not implement the
1079school readiness program until the coalition is authorized
1080through approval of the coalition's school readiness plan by the
1081Agency for Workforce Innovation.
1082 2. Each early learning coalition shall develop a plan for
1083implementing the school readiness program to meet the
1084requirements of this section and the performance standards and
1085outcome measures adopted by the Agency for Workforce Innovation.
1086The plan must demonstrate how the program will ensure that each
10873-year-old and 4-year-old child in a publicly funded school
1088readiness program receives scheduled activities and instruction
1089designed to enhance the age-appropriate progress of the children
1090in attaining the performance standards adopted by the Agency for
1091Workforce Innovation under subparagraph (4)(d)8. Before
1092implementing the school readiness program, the early learning
1093coalition must submit the plan to the Agency for Workforce
1094Innovation for approval. The Agency for Workforce Innovation may
1095approve the plan, reject the plan, or approve the plan with
1096conditions. The Agency for Workforce Innovation shall review
1097school readiness plans at least annually.
1098 3. If the Agency for Workforce Innovation determines
1099during the annual review of school readiness plans, or through
1100monitoring and performance evaluations conducted under paragraph
1101(4)(l), that an early learning coalition has not substantially
1102implemented its plan, has not substantially met the performance
1103standards and outcome measures adopted by the agency, or has not
1104effectively administered the school readiness program or
1105Voluntary Prekindergarten Education Program, the Agency for
1106Workforce Innovation may dissolve the coalition and temporarily
1107contract with a qualified entity to continue school readiness
1108and prekindergarten services in the coalition's county or
1109multicounty region until the coalition is reestablished through
1110resubmission of a school readiness plan and approval by the
1111agency.
1112 4. The Agency for Workforce Innovation shall adopt
1113criteria for the approval of school readiness plans. The
1114criteria must be consistent with the performance standards and
1115outcome measures adopted by the agency and must require each
1116approved plan to include the following minimum standards and
1117provisions:
1118 a. A sliding fee scale establishing a copayment for
1119parents based upon their ability to pay, which is the same for
1120all program providers, to be implemented and reflected in each
1121program's budget.
1122 b. A choice of settings and locations in licensed,
1123registered, religious-exempt, or school-based programs to be
1124provided to parents.
1125 c. Instructional staff who have completed the training
1126course as required in s. 402.305(2)(d)1., as well as staff who
1127have additional training or credentials as required by the
1128Agency for Workforce Innovation. The plan must provide a method
1129for assuring the qualifications of all personnel in all program
1130settings.
1131 d. Specific eligibility priorities for children within the
1132early learning coalition's county or multicounty region in
1133accordance with subsection (6).
1134 e. Performance standards and outcome measures adopted by
1135the Agency for Workforce Innovation.
1136 f. Payment rates adopted by the early learning coalition
1137and approved by the Agency for Workforce Innovation. Payment
1138rates may not have the effect of limiting parental choice or
1139creating standards or levels of services that have not been
1140authorized by the Legislature.
1141 g. Systems support services, including a central agency,
1142child care resource and referral, eligibility determinations,
1143training of providers, and parent support and involvement.
1144 h. Direct enhancement services to families and children.
1145System support and direct enhancement services shall be in
1146addition to payments for the placement of children in school
1147readiness programs.
1148 i. The business organization of the early learning
1149coalition, which must include the coalition's articles of
1150incorporation and bylaws if the coalition is organized as a
1151corporation. If the coalition is not organized as a corporation
1152or other business entity, the plan must include the contract
1153with a fiscal agent. An early learning coalition may contract
1154with other coalitions to achieve efficiency in multicounty
1155services, and these contracts may be part of the coalition's
1156school readiness plan.
1157 j. Strategies to meet the needs of unique populations,
1158such as migrant workers.
1159
1160As part of the school readiness plan, the early learning
1161coalition may request the Governor to apply for a waiver to
1162allow the coalition to administer the Head Start Program to
1163accomplish the purposes of the school readiness program. If a
1164school readiness plan demonstrates that specific statutory goals
1165can be achieved more effectively by using procedures that
1166require modification of existing rules, policies, or procedures,
1167a request for a waiver to the Agency for Workforce Innovation
1168may be submitted as part of the plan. Upon review, the Agency
1169for Workforce Innovation may grant the proposed modification.
1170 5. Persons with an early childhood teaching certificate
1171may provide support and supervision to other staff in the school
1172readiness program.
1173 6. An early learning coalition may not implement its
1174school readiness plan until it submits the plan to and receives
1175approval from the Agency for Workforce Innovation. Once the plan
1176is approved, the plan and the services provided under the plan
1177shall be controlled by the early learning coalition. The plan
1178shall be reviewed and revised as necessary, but at least
1179biennially. An early learning coalition may not implement the
1180revisions until the coalition submits the revised plan to and
1181receives approval from the Agency for Workforce Innovation. If
1182the Agency for Workforce Innovation rejects a revised plan, the
1183coalition must continue to operate under its prior approved
1184plan.
1185 7. Sections 125.901(2)(a)3. and, 411.221, and 411.232 do
1186not apply to an early learning coalition with an approved school
1187readiness plan. To facilitate innovative practices and to allow
1188the regional establishment of school readiness programs, an
1189early learning coalition may apply to the Governor and Cabinet
1190for a waiver of, and the Governor and Cabinet may waive, any of
1191the provisions of ss. 411.223, 411.232, and 1003.54, if the
1192waiver is necessary for implementation of the coalition's school
1193readiness plan.
1194 8. Two or more counties may join for purposes of planning
1195and implementing a school readiness program.
1196 9. An early learning coalition may, subject to approval by
1197the Agency for Workforce Innovation as part of the coalition's
1198school readiness plan, receive subsidized child care funds for
1199all children eligible for any federal subsidized child care
1200program.
1201 10. An early learning coalition may enter into multiparty
1202contracts with multicounty service providers in order to meet
1203the needs of unique populations such as migrant workers.
1204 Section 21. Subsection (2) of section 411.224, Florida
1205Statutes, is amended to read:
1206 411.224 Family support planning process.-The Legislature
1207establishes a family support planning process to be used by the
1208Department of Children and Family Services as the service
1209planning process for targeted individuals, children, and
1210families under its purview.
1211 (2) To the extent possible within existing resources, the
1212following populations must be included in the family support
1213planning process:
1214 (a) Children from birth to age 5 who are served by the
1215clinic and programs of the Division of Children's Medical
1216Services of the Department of Health.
1217 (b) Children participating in the developmental evaluation
1218and intervention program of the Division of Children's Medical
1219Services of the Department of Health.
1220 (c) Children from age 3 through age 5 who are served by
1221the Agency for Persons with Disabilities.
1222 (d) Children from birth through age 5 who are served by
1223the Mental Health Program Office of the Department of Children
1224and Family Services.
1225 (e) Participants who are served by the Children's Early
1226Investment Program established in s. 411.232.
1227 (e)(f) Healthy Start participants in need of ongoing
1228service coordination.
1229 (f)(g) Children from birth through age 5 who are served by
1230the voluntary family services, protective supervision, foster
1231care, or adoption and related services programs of the Child
1232Care Services Program Office of the Department of Children and
1233Family Services, and who are eligible for ongoing services from
1234one or more other programs or agencies that participate in
1235family support planning; however, children served by the
1236voluntary family services program, where the planned length of
1237intervention is 30 days or less, are excluded from this
1238population.
1239 Section 22. Subsections (32) through (54) of section
1240499.003, Florida Statutes, are renumbered as subsections (33)
1241through (55), respectively, present subsection (42) is amended,
1242and a new subsection (32) is added to that section, to read:
1243 499.003 Definitions of terms used in this part.-As used in
1244this part, the term:
1245 (32) "Medical convenience kit" means packages or units
1246that contain combination products as defined in 21 C.F.R. s.
12473.2(e)(2).
1248 (43)(42) "Prescription drug" means a prescription,
1249medicinal, or legend drug, including, but not limited to,
1250finished dosage forms or active ingredients subject to, defined
1251by, or described by s. 503(b) of the Federal Food, Drug, and
1252Cosmetic Act or s. 465.003(8), s. 499.007(13), or subsection
1253(11), subsection (46) (45), or subsection (53) (52).
1254 Section 23. Paragraph (q) of subsection (2) of section
1255499.01, Florida Statutes, is amended to read:
1256 499.01 Permits.-
1257 (2) The following permits are established:
1258 (q) Device manufacturer permit.-
1259 1. A device manufacturer permit is required for any person
1260that engages in the manufacture, repackaging, or assembly of
1261medical devices for human use in this state, except that a
1262permit is not required if:
1263 a. The person is engaged only in manufacturing,
1264repackaging, or assembling a medical device pursuant to a
1265practitioner's order for a specific patient; or
1266 b. The person does not manufacture, repackage, or assemble
1267any medical devices or components for such devices, except those
1268devices or components which are exempt from registration
1269pursuant to s. 499.015(8).
1270 2.1. A manufacturer or repackager of medical devices in
1271this state must comply with all appropriate state and federal
1272good manufacturing practices and quality system rules.
1273 3.2. The department shall adopt rules related to storage,
1274handling, and recordkeeping requirements for manufacturers of
1275medical devices for human use.
1276 Section 24. Paragraph (i) is added to subsection (3) of
1277section 499.01212, Florida Statutes, to read:
1278 499.01212 Pedigree paper.-
1279 (3) EXCEPTIONS.-A pedigree paper is not required for:
1280 (i) The wholesale distribution of prescription drugs
1281within a medical convenience kit if:
1282 1. The medical convenience kit is assembled in an
1283establishment that is registered with the United States Food and
1284Drug Administration as a medical device manufacturer;
1285 2. The medical convenience kit manufacturer purchased the
1286prescription drug directly from the manufacturer or from a
1287wholesaler that purchased the prescription drug directly from
1288the manufacturer;
1289 3. The medical convenience kit manufacturer complies with
1290federal law for the distribution of the prescription drugs
1291within the kit; and
1292 4. The drugs contained in the medical kit are:
1293 a. Intravenous solutions intended for the replenishment of
1294fluids and electrolytes;
1295 b. Products intended to maintain the equilibrium of water
1296and minerals in the body;
1297 c. Products intended for irrigation or reconstitution;
1298 d. Anesthetics; or
1299 e. Anticoagulants.
1300
1301This exemption does not apply to a convenience kit containing
1302any controlled substance that appears in a schedule contained in
1303or subject to chapter 893 or the federal Comprehensive Drug
1304Abuse Prevention and Control Act of 1970.
1305 Section 25. Subsections (4) and (5) of section 509.013,
1306Florida Statutes, are amended to read:
1307 509.013 Definitions.-As used in this chapter, the term:
1308 (4)(a) "Public lodging establishment" includes a transient
1309public lodging establishment as defined in subparagraph 1. and a
1310nontransient public lodging establishment as defined in
1311subparagraph 2.
1312 1. "Transient public lodging establishment" means any
1313unit, group of units, dwelling, building, or group of buildings
1314within a single complex of buildings which is rented to guests
1315more than three times in a calendar year for periods of less
1316than 30 days or 1 calendar month, whichever is less, or which is
1317advertised or held out to the public as a place regularly rented
1318to guests.
1319 2. "Nontransient public lodging establishment" means any
1320unit, group of units, dwelling, building, or group of buildings
1321within a single complex of buildings which is rented to guests
1322for periods of at least 30 days or 1 calendar month, whichever
1323is less, or which is advertised or held out to the public as a
1324place regularly rented to guests for periods of at least 30 days
1325or 1 calendar month.
1326
1327License classifications of public lodging establishments, and
1328the definitions therefor, are set out in s. 509.242. For the
1329purpose of licensure, the term does not include condominium
1330common elements as defined in s. 718.103.
1331 (b) The following are excluded from the definitions in
1332paragraph (a):
1333 1. Any dormitory or other living or sleeping facility
1334maintained by a public or private school, college, or university
1335for the use of students, faculty, or visitors;
1336 2. Any facility certified or licensed and regulated by the
1337Agency for Health Care Administration or the Department of
1338Children and Family Services hospital, nursing home, sanitarium,
1339assisted living facility, or other similar place regulated under
1340s. 381.0072;
1341 3. Any place renting four rental units or less, unless the
1342rental units are advertised or held out to the public to be
1343places that are regularly rented to transients;
1344 4. Any unit or group of units in a condominium,
1345cooperative, or timeshare plan and any individually or
1346collectively owned one-family, two-family, three-family, or
1347four-family dwelling house or dwelling unit that is rented for
1348periods of at least 30 days or 1 calendar month, whichever is
1349less, and that is not advertised or held out to the public as a
1350place regularly rented for periods of less than 1 calendar
1351month, provided that no more than four rental units within a
1352single complex of buildings are available for rent;
1353 5. Any migrant labor camp or residential migrant housing
1354permitted by the Department of Health; under ss. 381.008-
1355381.00895; and
1356 6. Any establishment inspected by the Department of Health
1357and regulated by chapter 513.
1358 (5)(a) "Public food service establishment" means any
1359building, vehicle, place, or structure, or any room or division
1360in a building, vehicle, place, or structure where food is
1361prepared, served, or sold for immediate consumption on or in the
1362vicinity of the premises; called for or taken out by customers;
1363or prepared prior to being delivered to another location for
1364consumption.
1365 (b) The following are excluded from the definition in
1366paragraph (a):
1367 1. Any place maintained and operated by a public or
1368private school, college, or university:
1369 a. For the use of students and faculty; or
1370 b. Temporarily to serve such events as fairs, carnivals,
1371and athletic contests.
1372 2. Any eating place maintained and operated by a church or
1373a religious, nonprofit fraternal, or nonprofit civic
1374organization:
1375 a. For the use of members and associates; or
1376 b. Temporarily to serve such events as fairs, carnivals,
1377or athletic contests.
1378 3. Any eating place located on an airplane, train, bus, or
1379watercraft which is a common carrier.
1380 4. Any eating place maintained by a facility certified or
1381licensed and regulated by the Agency for Health Care
1382Administration or the Department of Children and Family Services
1383hospital, nursing home, sanitarium, assisted living facility,
1384adult day care center, or other similar place that is regulated
1385under s. 381.0072.
1386 5. Any place of business issued a permit or inspected by
1387the Department of Agriculture and Consumer Services under s.
1388500.12.
1389 6. Any place of business where the food available for
1390consumption is limited to ice, beverages with or without
1391garnishment, popcorn, or prepackaged items sold without
1392additions or preparation.
1393 7. Any theater, if the primary use is as a theater and if
1394patron service is limited to food items customarily served to
1395the admittees of theaters.
1396 8. Any vending machine that dispenses any food or
1397beverages other than potentially hazardous foods, as defined by
1398division rule.
1399 9. Any vending machine that dispenses potentially
1400hazardous food and which is located in a facility regulated
1401under s. 381.0072.
1402 10. Any research and development test kitchen limited to
1403the use of employees and which is not open to the general
1404public.
1405 Section 26. The Department of Health shall develop a plan
1406that exclusively uses private and nonstate public hospitals to
1407provide treatment to cure, hospitalization, and isolation for
1408persons with contagious cases of tuberculosis who pose a threat
1409to the public. The department shall submit the plan to the
1410Governor, the President of the Senate, and the Speaker of the
1411House of Representatives by November 1, 2010. The plan shall
1412include the following elements:
1413 (1) Identification of hospitals functionally capable of
1414caring for such patients.
1415 (2) Reimbursement for hospital inpatient services at the
1416Medicaid rate and reimbursement for other medically necessary
1417services that are not hospital inpatient services at the
1418relevant Medicaid rate.
1419 (3) Projected cost estimates.
1420 (4) A transition plan for closing the A. G. Holley State
1421Hospital and transferring patients to private and nonstate
1422public hospitals over a 90-day period of time.
1423 Section 27. (1) All of the statutory powers, duties, and
1424functions, records, personnel, property, and unexpended balances
1425of appropriations, allocations, or other funds for the
1426administration of chapter 499, Florida Statutes, relating to
1427drugs, devices, cosmetics, and household products shall be
1428transferred by a type two transfer, as defined in s. 20.06(2),
1429Florida Statutes, from the Department of Health to the
1430Department of Business and Professional Regulation.
1431 (2) The transfer of regulatory authority under chapter
1432499, Florida Statutes, provided by this section shall not affect
1433the validity of any judicial or administrative action pending as
1434of 11:59 p.m. on the day before the effective date of this
1435section to which the Department of Health is at that time a
1436party, and the Department of Business and Professional
1437Regulation shall be substituted as a party in interest in any
1438such action.
1439 (3) All lawful orders issued by the Department of Health
1440implementing or enforcing or otherwise in regard to any
1441provision of chapter 499, Florida Statutes, issued prior to the
1442effective date of this section shall remain in effect and be
1443enforceable after the effective date of this section unless
1444thereafter modified in accordance with law.
1445 (4) The rules of the Department of Health relating to the
1446implementation of chapter 499, Florida Statutes, that were in
1447effect at 11:59 p.m. on the day prior to the effective date of
1448this section shall become the rules of the Department of
1449Business and Professional Regulation and shall remain in effect
1450until amended or repealed in the manner provided by law.
1451 (5) Notwithstanding the transfer of regulatory authority
1452under chapter 499, Florida Statutes, provided by this section,
1453persons and entities holding in good standing any permit under
1454chapter 499, Florida Statutes, as of 11:59 p.m. on the day prior
1455to the effective date of this section shall, as of the effective
1456date of this section, be deemed to hold in good standing a
1457permit in the same capacity as that for which the permit was
1458formerly issued.
1459 (6) Notwithstanding the transfer of regulatory authority
1460under chapter 499, Florida Statutes, provided by this section,
1461persons holding in good standing any certification under chapter
1462499, Florida Statutes, as of 11:59 p.m. on the day prior to the
1463effective date of this section shall, as of the effective date
1464of this section, be deemed to be certified in the same capacity
1465in which they were formerly certified.
1466 (7) This section shall take effect October 1, 2011.
1467 Section 28. Paragraph (a) of subsection (3) and
1468subsections (9) and (10) of section 381.0403, Florida Statutes,
1469are amended to read:
1470 381.0403 The Community Hospital Education Act.-
1471 (3) PROGRAM FOR COMMUNITY HOSPITAL EDUCATION; STATE AND
1472LOCAL PLANNING.-
1473 (a) There is established under the Department of Health a
1474program for statewide graduate medical education. It is intended
1475that continuing graduate medical education programs for interns
1476and residents be established on a statewide basis. The program
1477shall provide financial support for primary care specialty
1478interns and residents based on policies recommended and approved
1479by the Community Hospital Education Council, herein established,
1480and the Department of Health. Only those programs with at least
1481three residents or interns in each year of the training program
1482are qualified to apply for financial support. Programs with
1483fewer than three residents or interns per training year are
1484qualified to apply for financial support, but only if the
1485appropriate accrediting entity for the particular specialty has
1486approved the program for fewer positions. Programs added after
1487fiscal year 1997-1998 shall have 5 years to attain the requisite
1488number of residents or interns. When feasible and to the extent
1489allowed through the General Appropriations Act, state funds
1490shall be used to generate federal matching funds under Medicaid,
1491or other federal programs, and the resulting combined state and
1492federal funds shall be allocated to participating hospitals for
1493the support of graduate medical education. The department may
1494spend up to $75,000 of the state appropriation for
1495administrative costs associated with the production of the
1496annual report as specified in subsection (9), and for
1497administration of the program.
1498 (9) ANNUAL REPORT ON GRADUATE MEDICAL EDUCATION;
1499COMMITTEE.-The Executive Office of the Governor, the Department
1500of Health, and the Agency for Health Care Administration shall
1501collaborate to establish a committee that shall produce an
1502annual report on graduate medical education. The committee shall
1503be comprised of 11 members: five members shall be deans of the
1504medical schools or their designees; the Governor shall appoint
1505two members, one of whom must be a representative of the Florida
1506Medical Association who has supervised or currently supervises
1507residents or interns and one of whom must be a representative of
1508the Florida Hospital Association; the Secretary of Health Care
1509Administration shall appoint two members, one of whom must be a
1510representative of a statutory teaching hospital and one of whom
1511must be a physician who has supervised or is currently
1512supervising residents or interns; and the State Surgeon General
1513shall appoint two members, one of whom must be a representative
1514of a statutory family practice teaching hospital and one of whom
1515must be a physician who has supervised or is currently
1516supervising residents or interns. With the exception of the
1517deans, members shall serve 4-year terms. In order to stagger the
1518terms, the Governor's appointees shall serve initial terms of 4
1519years, the State Surgeon General's appointees shall serve
1520initial terms of 3 years, and the Secretary of Health Care
1521Administration's appointees shall serve initial terms of 2
1522years. A member's term shall be deemed terminated when the
1523member's representative status no longer exists. Once the
1524committee is appointed, it shall elect a chair to serve for a 1-
1525year term. The report shall be provided to the Governor, the
1526President of the Senate, and the Speaker of the House of
1527Representatives by January 15 annually. Committee members shall
1528serve without compensation. The report shall address the
1529following:
1530 (a) The role of residents and medical faculty in the
1531provision of health care.
1532 (b) The relationship of graduate medical education to the
1533state's physician workforce.
1534 (c) The costs of training medical residents for hospitals,
1535medical schools, teaching hospitals, including all hospital-
1536medical affiliations, practice plans at all of the medical
1537schools, and municipalities.
1538 (d) The availability and adequacy of all sources of
1539revenue to support graduate medical education and recommend
1540alternative sources of funding for graduate medical education.
1541 (e) The use of state and federal appropriated funds for
1542graduate medical education by hospitals receiving such funds.
1543 (9)(10) RULEMAKING.-The department has authority to adopt
1544rules pursuant to ss. 120.536(1) and 120.54 to implement the
1545provisions of this section.
1546 Section 29. Section 381.4018, Florida Statutes, is amended
1547to read:
1548 381.4018 Physician workforce assessment and development.-
1549 (1) DEFINITIONS.-As used in this section, the term:
1550 (a) "Consortium" or "consortia" means a combination of
1551statutory teaching hospitals, specialty children's hospitals,
1552statutory rural hospitals, other hospitals, accredited medical
1553schools, clinics operated by the Department of Health, clinics
1554operated by the Department of Veterans' Affairs, area health
1555education centers, community health centers, federally qualified
1556health centers, prison clinics, local community clinics, or
1557other programs. At least one member of the consortium shall be a
1558sponsoring institution accredited or currently seeking
1559accreditation by the Accreditation Council for Graduate Medical
1560Education or the American Osteopathic Association.
1561 (b) "Council" means the Physician Workforce Advisory
1562Council.
1563 (c) "Department" means the Department of Health.
1564 (d) "Graduate medical education program" means a program
1565accredited by the Accreditation Council for Graduate Medical
1566Education or the American Osteopathic Association.
1567 (e) "Primary care specialty" means emergency medicine,
1568family practice, internal medicine, pediatrics, psychiatry,
1569geriatrics, general surgery, obstetrics and gynecology, and
1570combined pediatrics and internal medicine and other specialties
1571as determined by the Physician Workforce Advisory Council or the
1572Department of Health.
1573 (2)(1) LEGISLATIVE INTENT.-The Legislature recognizes that
1574physician workforce planning is an essential component of
1575ensuring that there is an adequate and appropriate supply of
1576well-trained physicians to meet this state's future health care
1577service needs as the general population and elderly population
1578of the state increase. The Legislature finds that items to
1579consider relative to assessing the physician workforce may
1580include physician practice status; specialty mix; geographic
1581distribution; demographic information, including, but not
1582limited to, age, gender, race, and cultural considerations; and
1583needs of current or projected medically underserved areas in the
1584state. Long-term strategic planning is essential as the period
1585from the time a medical student enters medical school to
1586completion of graduate medical education may range from 7 to 10
1587years or longer. The Legislature recognizes that strategies to
1588provide for a well-trained supply of physicians must include
1589ensuring the availability and capacity of quality graduate
1590medical schools and graduate medical education programs in this
1591state, as well as using new or existing state and federal
1592programs providing incentives for physicians to practice in
1593needed specialties and in underserved areas in a manner that
1594addresses projected needs for physician manpower.
1595 (3)(2) PURPOSE.-The department of Health shall serve as a
1596coordinating and strategic planning body to actively assess the
1597state's current and future physician workforce needs and work
1598with multiple stakeholders to develop strategies and
1599alternatives to address current and projected physician
1600workforce needs.
1601 (4)(3) GENERAL FUNCTIONS.-The department shall maximize
1602the use of existing programs under the jurisdiction of the
1603department and other state agencies and coordinate governmental
1604and nongovernmental stakeholders and resources in order to
1605develop a state strategic plan and assess the implementation of
1606such strategic plan. In developing the state strategic plan, the
1607department shall:
1608 (a) Monitor, evaluate, and report on the supply and
1609distribution of physicians licensed under chapter 458 or chapter
1610459. The department shall maintain a database to serve as a
1611statewide source of data concerning the physician workforce.
1612 (b) Develop a model and quantify, on an ongoing basis, the
1613adequacy of the state's current and future physician workforce
1614as reliable data becomes available. Such model must take into
1615account demographics, physician practice status, place of
1616education and training, generational changes, population growth,
1617economic indicators, and issues concerning the "pipeline" into
1618medical education.
1619 (c) Develop and recommend strategies to determine whether
1620the number of qualified medical school applicants who might
1621become competent, practicing physicians in this state will be
1622sufficient to meet the capacity of the state's medical schools.
1623If appropriate, the department shall, working with
1624representatives of appropriate governmental and nongovernmental
1625entities, develop strategies and recommendations and identify
1626best practice programs that introduce health care as a
1627profession and strengthen skills needed for medical school
1628admission for elementary, middle, and high school students, and
1629improve premedical education at the precollege and college level
1630in order to increase this state's potential pool of medical
1631students.
1632 (d) Develop strategies to ensure that the number of
1633graduates from the state's public and private allopathic and
1634osteopathic medical schools is are adequate to meet physician
1635workforce needs, based on the analysis of the physician
1636workforce data, so as to provide a high-quality medical
1637education to students in a manner that recognizes the uniqueness
1638of each new and existing medical school in this state.
1639 (e) Pursue strategies and policies to create, expand, and
1640maintain graduate medical education positions in the state based
1641on the analysis of the physician workforce data. Such strategies
1642and policies must take into account the effect of federal
1643funding limitations on the expansion and creation of positions
1644in graduate medical education. The department shall develop
1645options to address such federal funding limitations. The
1646department shall consider options to provide direct state
1647funding for graduate medical education positions in a manner
1648that addresses requirements and needs relative to accreditation
1649of graduate medical education programs. The department shall
1650consider funding residency positions as a means of addressing
1651needed physician specialty areas, rural areas having a shortage
1652of physicians, and areas of ongoing critical need, and as a
1653means of addressing the state's physician workforce needs based
1654on an ongoing analysis of physician workforce data.
1655 (f) Develop strategies to maximize federal and state
1656programs that provide for the use of incentives to attract
1657physicians to this state or retain physicians within the state.
1658Such strategies should explore and maximize federal-state
1659partnerships that provide incentives for physicians to practice
1660in federally designated shortage areas. Strategies shall also
1661consider the use of state programs, such as the Florida Health
1662Service Corps established pursuant to s. 381.0302 and the
1663Medical Education Reimbursement and Loan Repayment Program
1664pursuant to s. 1009.65, which provide for education loan
1665repayment or loan forgiveness and provide monetary incentives
1666for physicians to relocate to underserved areas of the state.
1667 (g) Coordinate and enhance activities relative to
1668physician workforce needs, undergraduate medical education, and
1669graduate medical education, and reentry of retired military and
1670other physicians into the physician workforce provided by the
1671Division of Medical Quality Assurance, the Community Hospital
1672Education Program and the Graduate Medical Education Committee
1673established pursuant to s. 381.0403, area health education
1674center networks established pursuant to s. 381.0402, and other
1675offices and programs within the department of Health as
1676designated by the State Surgeon General.
1677 (h) Work in conjunction with and act as a coordinating
1678body for governmental and nongovernmental stakeholders to
1679address matters relating to the state's physician workforce
1680assessment and development for the purpose of ensuring an
1681adequate supply of well-trained physicians to meet the state's
1682future needs. Such governmental stakeholders shall include, but
1683need not be limited to, the State Surgeon General or his or her
1684designee, the Commissioner of Education or his or her designee,
1685the Secretary of Health Care Administration or his or her
1686designee, and the Chancellor of the State University System or
1687his or her designee from the Board of Governors of the State
1688University System, and, at the discretion of the department,
1689other representatives of state and local agencies that are
1690involved in assessing, educating, or training the state's
1691current or future physicians. Other stakeholders shall include,
1692but need not be limited to, organizations representing the
1693state's public and private allopathic and osteopathic medical
1694schools; organizations representing hospitals and other
1695institutions providing health care, particularly those that
1696currently provide or have an interest in providing accredited
1697medical education and graduate medical education to medical
1698students and medical residents; organizations representing
1699allopathic and osteopathic practicing physicians; and, at the
1700discretion of the department, representatives of other
1701organizations or entities involved in assessing, educating, or
1702training the state's current or future physicians.
1703 (i) Serve as a liaison with other states and federal
1704agencies and programs in order to enhance resources available to
1705the state's physician workforce and medical education continuum.
1706 (j) Act as a clearinghouse for collecting and
1707disseminating information concerning the physician workforce and
1708medical education continuum in this state.
1709 (5) PHYSICIAN WORKFORCE ADVISORY COUNCIL.-There is created
1710in the department the Physician Workforce Advisory Council, an
1711advisory council as defined in s. 20.03. The council shall
1712comply with the requirements of s. 20.052, except as otherwise
1713provided in this section.
1714 (a) The council shall consist of 19 members. Members
1715appointed by the State Surgeon General shall include:
1716 1. A designee from the department who is a physician
1717licensed under chapter 458 or chapter 459 and recommended by the
1718State Surgeon General.
1719 2. An individual who is affiliated with the Science
1720Students Together Reaching Instructional Diversity and
1721Excellence program and recommended by the area health education
1722center network.
1723 3. Two individuals recommended by the Council of Florida
1724Medical School Deans, one representing a college of allopathic
1725medicine and one representing a college of osteopathic medicine.
1726 4. One individual recommended by the Florida Hospital
1727Association, representing a hospital that is licensed under
1728chapter 395, has an accredited graduate medical education
1729program, and is not a statutory teaching hospital.
1730 5. One individual representing a statutory teaching
1731hospital as defined in s. 408.07 and recommended by the Safety
1732Net Hospital Alliance.
1733 6. One individual representing a family practice teaching
1734hospital as defined in s. 395.805 and recommended by the Council
1735of Family Medicine and Community Teaching Hospitals.
1736 7. Two individuals recommended by the Florida Medical
1737Association, one representing a primary care specialty and one
1738representing a nonprimary care specialty.
1739 8. Two individuals recommended by the Florida Osteopathic
1740Medical Association, one representing a primary care specialty
1741and one representing a nonprimary care specialty.
1742 9. Two individuals who are program directors of accredited
1743graduate medical education programs, one representing a program
1744that is accredited by the Accreditation Council for Graduate
1745Medical Education and one representing a program that is
1746accredited by the American Osteopathic Association.
1747 10. An individual recommended by the Florida Association
1748of Community Health Centers representing a federally qualified
1749health center located in a rural area as defined in s.
1750381.0406(2)(a).
1751 11. An individual recommended by the Florida Academy of
1752Family Physicians.
1753 12. An individual recommended by the Florida Alliance for
1754Health Professions Diversity.
1755 13. The Chancellor of the State University System or his
1756or her designee.
1757 14. A layperson member as determined by the State Surgeon
1758General.
1759
1760Appointments to the council shall be made by the State Surgeon
1761General. Each entity authorized to make recommendations under
1762this subsection shall make at least two recommendations to the
1763State Surgeon General for each appointment to the council. The
1764State Surgeon General shall name one appointee for each position
1765from the recommendations made by each authorized entity.
1766 (b) Each council member shall be appointed to a 4-year
1767term. An individual may not serve more than two terms. Any
1768council member may be removed from office for malfeasance;
1769misfeasance; neglect of duty; incompetence; permanent inability
1770to perform official duties; or pleading guilty or nolo
1771contendere to, or being found guilty of, a felony. Any council
1772member who meets the criteria for removal, or who is otherwise
1773unwilling or unable to properly fulfill the duties of the
1774office, shall be succeeded by an individual chosen by the State
1775Surgeon General to serve out the remainder of the council
1776member's term. If the remainder of the replaced council member's
1777term is less than 18 months, notwithstanding the provisions of
1778this paragraph, the succeeding council member may be reappointed
1779twice by the State Surgeon General.
1780 (c) The chair of the council is the State Surgeon General,
1781who shall designate a vice chair from the membership of the
1782council to serve in the absence of the State Surgeon General. A
1783vacancy shall be filled for the remainder of the unexpired term
1784in the same manner as the original appointment.
1785 (d) Council members are not entitled to receive
1786compensation or reimbursement for per diem or travel expenses.
1787 (e) The council shall meet at least twice a year in person
1788or by teleconference.
1789 (f) The council shall:
1790 1. Advise the State Surgeon General and the department on
1791matters concerning current and future physician workforce needs
1792in this state;
1793 2. Review survey materials and the compilation of survey
1794information;
1795 3. Annually review the number, location, cost, and
1796reimbursement of graduate medical education programs and
1797positions;
1798 4. Provide recommendations to the department regarding the
1799survey completed by physicians licensed under chapter 458 or
1800chapter 459;
1801 5. Assist the department in preparing the annual report to
1802the Legislature pursuant to ss. 458.3192 and 459.0082;
1803 6. Assist the department in preparing an initial strategic
1804plan, conduct ongoing strategic planning in accordance with this
1805section, and provide ongoing advice on implementing the
1806recommendations;
1807 7. Monitor and provide recommendations regarding the need
1808for an increased number of primary care or other physician
1809specialties to provide the necessary current and projected
1810health and medical services for the state; and
1811 8. Monitor and make recommendations regarding the status
1812of the needs relating to graduate medical education in this
1813state.
1814 Section 30. Section 458.3192, Florida Statutes, is amended
1815to read:
1816 458.3192 Analysis of survey results; report.-
1817 (1) Each year, the Department of Health shall analyze the
1818results of the physician survey required by s. 458.3191 and
1819determine by geographic area and specialty the number of
1820physicians who:
1821 (a) Perform deliveries of children in this state Florida.
1822 (b) Read mammograms and perform breast-imaging-guided
1823procedures in this state Florida.
1824 (c) Perform emergency care on an on-call basis for a
1825hospital emergency department.
1826 (d) Plan to reduce or increase emergency on-call hours in
1827a hospital emergency department.
1828 (e) Plan to relocate their allopathic or osteopathic
1829practice outside the state.
1830 (f) Practice medicine in this state.
1831 (g) Plan to reduce or modify the scope of their practice.
1832 (2) The Department of Health must report its findings to
1833the Governor, the President of the Senate, and the Speaker of
1834the House of Representatives by November 1 each year. The
1835department shall also include in its report findings,
1836recommendations, and strategic planning activities as provided
1837in s. 381.4018. The department may also include other
1838information requested by the Physician Workforce Advisory
1839Council.
1840 Section 31. Section 459.0082, Florida Statutes, is amended
1841to read:
1842 459.0082 Analysis of survey results; report.-
1843 (1) Each year, the Department of Health shall analyze the
1844results of the physician survey required by s. 459.0081 and
1845determine by geographic area and specialty the number of
1846physicians who:
1847 (a) Perform deliveries of children in this state Florida.
1848 (b) Read mammograms and perform breast-imaging-guided
1849procedures in this state Florida.
1850 (c) Perform emergency care on an on-call basis for a
1851hospital emergency department.
1852 (d) Plan to reduce or increase emergency on-call hours in
1853a hospital emergency department.
1854 (e) Plan to relocate their allopathic or osteopathic
1855practice outside the state.
1856 (f) Practice medicine in this state.
1857 (g) Plan to reduce or modify the scope of their practice.
1858 (2) The Department of Health must report its findings to
1859the Governor, the President of the Senate, and the Speaker of
1860the House of Representatives by November 1 each year. The
1861department shall also include in its report findings,
1862recommendations, and strategic planning activities as provided
1863in s. 381.4018. The department may also include other
1864information requested by the Physician Workforce Advisory
1865Council.
1866 Section 32. Section 458.315, Florida Statutes, is amended
1867to read:
1868 458.315 Temporary certificate for practice in areas of
1869critical need.-
1870 (1) Any physician who:
1871 (a) Is licensed to practice in any jurisdiction in the
1872United States and other state, whose license is currently valid;
1873or,
1874 (b) Has served as a physician in the United States Armed
1875Forces for at least 10 years and received an honorable discharge
1876from the military;
1877
1878and who pays an application fee of $300 may be issued a
1879temporary certificate for to practice in areas of communities of
1880Florida where there is a critical need for physicians.
1881 (2) A certificate may be issued to a physician who:
1882 (a) Will practice in an area of critical need;
1883 (b) Will be employed by or practice in a county health
1884department, correctional facility, Department of Veterans'
1885Affairs clinic, community health center funded by s. 329, s.
1886330, or s. 340 of the United States Public Health Services Act,
1887or other agency or institution that is approved by the State
1888Surgeon General and provides health care to meet the needs of
1889underserved populations in this state; or
1890 (c) Will practice for a limited time to address critical
1891physician-specialty, demographic, or geographic needs for this
1892state's physician workforce as determined by the State Surgeon
1893General entity that provides health care to indigents and that
1894is approved by the State Health Officer.
1895 (3) The Board of Medicine may issue this temporary
1896certificate with the following restrictions:
1897 (a)(1) The State Surgeon General board shall determine the
1898areas of critical need, and the physician so certified may
1899practice in any of those areas for a time to be determined by
1900the board. Such areas shall include, but are not be limited to,
1901health professional shortage areas designated by the United
1902States Department of Health and Human Services.
1903 1.(a) A recipient of a temporary certificate for practice
1904in areas of critical need may use the certificate license to
1905work for any approved entity employer in any area of
1906need or as authorized by the State Surgeon General approved by
1907the board.
1908 2.(b) The recipient of a temporary certificate for
1909practice in areas of critical need shall, within 30 days after
1910accepting employment, notify the board of all approved
1911institutions in which the licensee practices and of all approved
1912institutions where practice privileges have been denied.
1913 (b)(2) The board may administer an abbreviated oral
1914examination to determine the physician's competency, but a no
1915written regular examination is not required necessary. Within 60
1916days after receipt of an application for a temporary
1917certificate, the board shall review the application and issue
1918the temporary certificate, or notify the applicant of denial, or
1919notify the applicant that the board recommends additional
1920assessment, training, education, or other requirements as a
1921condition of certification. If the applicant has not actively
1922practiced during the prior 3 years and the board determines that
1923the applicant may lack clinical competency, possess diminished
1924or inadequate skills, lack necessary medical knowledge, or
1925exhibit patterns of deficits in clinical decisionmaking, the
1926board may:
1927 1. Deny the application;
1928 2. Issue a temporary certificate having reasonable
1929restrictions that may include, but are not limited to, a
1930requirement for the applicant to practice under the supervision
1931of a physician approved by the board; or
1932 3. Issue a temporary certificate upon receipt of
1933documentation confirming that the applicant has met any
1934reasonable conditions of the board which may include, but are
1935not limited to, completing continuing education or undergoing an
1936assessment of skills and training.
1937 (c)(3) Any certificate issued under this section is shall
1938be valid only so long as the State Surgeon General determines
1939that the reason area for which it was is issued remains a an
1940area of critical need to the state. The Board of Medicine shall
1941review each temporary certificateholder not the service within
1942said area not less than annually to ascertain that the minimum
1943requirements of the Medical Practice Act and its adopted the
1944rules and regulations promulgated thereunder are being complied
1945with. If it is determined that such minimum requirements are not
1946being met, the board shall forthwith revoke such certificate or
1947shall impose restrictions or conditions, or both, as a condition
1948of continued practice under the certificate.
1949 (d)(4) The board may shall not issue a temporary
1950certificate for practice in an area of critical need to any
1951physician who is under investigation in any jurisdiction in the
1952United States another state for an act that which would
1953constitute a violation of this chapter until such time as the
1954investigation is complete, at which time the provisions of s.
1955458.331 shall apply.
1956 (4)(5) The application fee and all licensure fees,
1957including neurological injury compensation assessments, shall be
1958waived for those persons obtaining a temporary certificate to
1959practice in areas of critical need for the purpose of providing
1960volunteer, uncompensated care for low-income residents
1961Floridians. The applicant must submit an affidavit from the
1962employing agency or institution stating that the physician will
1963not receive any compensation for any service involving the
1964practice of medicine.
1965 Section 33. Section 459.0076, Florida Statutes, is created
1966to read:
1967 459.0076 Temporary certificate for practice in areas of
1968critical need.-
1969 (1) Any physician who:
1970 (a) Is licensed to practice in any jurisdiction in the
1971United States and whose license is currently valid; or
1972 (b) Has served as a physician in the United States Armed
1973Forces for at least 10 years and received an honorable discharge
1974from the military;
1975
1976and who pays an application fee of $300 may be issued a
1977temporary certificate for practice in areas of critical need.
1978 (2) A certificate may be issued to a physician who:
1979 (a) Will practice in an area of critical need;
1980 (b) Will be employed by or practice in a county health
1981department, correctional facility, Department of Veterans'
1982Affairs clinic, community health center funded by s. 329, s.
1983330, or s. 340 of the United States Public Health Services Act,
1984or other agency or institution that is approved by the State
1985Surgeon General and provides health care to meet the needs of
1986underserved populations in this state; or
1987 (c) Will practice for a limited time to address critical
1988physician-specialty, demographic, or geographic needs for this
1989state's physician workforce as determined by the State Surgeon
1990General.
1991 (3) The Board of Osteopathic Medicine may issue this
1992temporary certificate with the following restrictions:
1993 (a) The State Surgeon General shall determine the areas of
1994critical need. Such areas include, but are not limited to,
1995health professional shortage areas designated by the United
1996States Department of Health and Human Services.
1997 1. A recipient of a temporary certificate for practice in
1998areas of critical need may use the certificate to work for any
1999approved entity in any area of critical need or as authorized by
2000the State Surgeon General.
2001 2. The recipient of a temporary certificate for practice
2002in areas of critical need shall, within 30 days after accepting
2003employment, notify the board of all approved institutions in
2004which the licensee practices and of all approved institutions
2005where practice privileges have been denied.
2006 (b) The board may administer an abbreviated oral
2007examination to determine the physician's competency, but a
2008written regular examination is not required. Within 60 days
2009after receipt of an application for a temporary certificate, the
2010board shall review the application and issue the temporary
2011certificate, notify the applicant of denial, or notify the
2012applicant that the board recommends additional assessment,
2013training, education, or other requirements as a condition of
2014certification. If the applicant has not actively practiced
2015during the prior 3 years and the board determines that the
2016applicant may lack clinical competency, possess diminished or
2017inadequate skills, lack necessary medical knowledge, or exhibit
2018patterns of deficits in clinical decisionmaking, the board may:
2019 1. Deny the application;
2020 2. Issue a temporary certificate having reasonable
2021restrictions that may include, but are not limited to, a
2022requirement for the applicant to practice under the supervision
2023of a physician approved by the board; or
2024 3. Issue a temporary certificate upon receipt of
2025documentation confirming that the applicant has met any
2026reasonable conditions of the board which may include, but are
2027not limited to, completing continuing education or undergoing an
2028assessment of skills and training.
2029 (c) Any certificate issued under this section is valid
2030only so long as the State Surgeon General determines that the
2031reason for which it was issued remains a critical need to the
2032state. The Board of Osteopathic Medicine shall review each
2033temporary certificateholder not less than annually to ascertain
2034that the minimum requirements of the Osteopathic Medical
2035Practice Act and its adopted rules are being complied with. If
2036it is determined that such minimum requirements are not being
2037met, the board shall revoke such certificate or shall impose
2038restrictions or conditions, or both, as a condition of continued
2039practice under the certificate.
2040 (d) The board may not issue a temporary certificate for
2041practice in an area of critical need to any physician who is
2042under investigation in any jurisdiction in the United States for
2043an act that would constitute a violation of this chapter until
2044such time as the investigation is complete, at which time the
2045provisions of s. 459.015 apply.
2046 (4) The application fee and all licensure fees, including
2047neurological injury compensation assessments, shall be waived
2048for those persons obtaining a temporary certificate to practice
2049in areas of critical need for the purpose of providing
2050volunteer, uncompensated care for low-income residents. The
2051applicant must submit an affidavit from the employing agency or
2052institution stating that the physician will not receive any
2053compensation for any service involving the practice of medicine.
2054 Section 34. (1) The Department of Health shall conduct an
2055evaluation and justification review of each division established
2056under s. 20.43, Florida Statutes. The review shall be
2057comprehensive in its scope and, at a minimum, must be conducted
2058in such a manner as to specifically determine the following, and
2059to consider and determine what changes, if any, are needed with
2060respect thereto:
2061 (a) The identifiable cost of each division and programs
2062within the division.
2063 (b) The specific purpose of each division and programs
2064within the division, and the specific public health benefit
2065derived therefrom.
2066 (c) Progress toward achieving the outputs and outcomes
2067associated with each division and programs within the division.
2068 (d) An explanation of circumstances contributing to the
2069department's ability to achieve, not achieve, or exceed its
2070projected outputs and outcomes, as defined in s. 216.011,
2071associated with each division and programs within the division.
2072 (e) Alternate courses of action that would result in
2073administration of the same program in a more efficient or
2074effective manner. The courses of action to be considered must
2075include, but are not limited to:
2076 1. Whether the department could be organized in a more
2077efficient and effective manner, including whether each
2078division's mission, goals, or objectives should be redefined.
2079The report must include a rationale for each department division
2080and programs within the division, the return on investment of
2081each division and programs within the division, the relatedness
2082of the division and programs within the division to a public
2083health function, and any federal funding support for each
2084division and programs within the division. The review should
2085recommend the reduction and restructuring of department bureaus
2086and divisions.
2087 2. Whether the division and programs within the division
2088could be administered more efficiently or effectively to avoid
2089duplication of activities and ensure that activities are
2090adequately coordinated.
2091 3. Whether the division and programs within that division
2092could be performed more efficiently or more effectively by
2093another unit of government or a private entity.
2094 4. When compared to costs, whether effectiveness warrants
2095elimination of the division or programs within the division or,
2096if the division or a program within the division serves a
2097limited interest, whether the division or program should be
2098redesigned to require users to finance program costs.
2099 5. Whether the cost to administer the division or program
2100within the division exceeds license and other fee revenues paid
2101by those being regulated.
2102 6. Whether other changes could improve the efficiency and
2103effectiveness of the division or program within the division.
2104 (f) The consequences of discontinuing such division or
2105programs within the division. If any discontinuation is
2106recommended, such recommendation must be accompanied by a
2107description of alternatives to implement such recommendation,
2108including an implementation schedule for discontinuation and
2109recommended procedures for assisting state agency employees
2110affected by the discontinuation.
2111 (g) Whether current performance measures and standards
2112should be reviewed or amended to assist department efforts in
2113achieving outputs and outcome measures.
2114 (h) Whether the information reported as part of the
2115state's performance-based program budgeting system has relevance
2116and utility for the evaluation of each division and programs
2117within the division.
2118 (i) Whether department management has established control
2119systems sufficient to ensure that performance data are
2120maintained and supported by department records and accurately
2121presented in department performance reports.
2122 (3) No later than March 1, 2011, the department shall
2123submit a report on its evaluation and justification review
2124findings and recommendations to the President of the Senate, the
2125Speaker of the House of Representatives, the chairs of the
2126appropriate substantive committees, the chairs of the
2127appropriations committees, the Legislative Auditing Committee,
2128the Governor, and the State Surgeon General.
2129 Section 35. Subsection (3) is added to section 381.00315,
2130Florida Statutes, to read:
2131 381.00315 Public health advisories; public health
2132emergencies.-The State Health Officer is responsible for
2133declaring public health emergencies and issuing public health
2134advisories.
2135 (3) To facilitate effective emergency management, when the
2136United States Department of Health and Human Services contracts
2137for the manufacture and delivery of licensable products in
2138response to a public health emergency and the terms of those
2139contracts are made available to the states, the department shall
2140accept funds provided by counties, municipalities, and other
2141entities designated in the state emergency management plan
2142required under s. 252.35(2)(a) for the purpose of participation
2143in those contracts. The department shall deposit those funds in
2144the Grants and Donations Trust Fund and expend those funds on
2145behalf of the donor county, municipality, or other entity for
2146the purchase of the licensable products made available under the
2147contract.
2148 Section 36. For fiscal year 2010-2011 only, and
2149notwithstanding s. 216.181, Florida Statutes, the Department of
2150Health is authorized to submit a budget amendment requesting
2151additional Grants and Donations Trust Fund budget authority for
2152the Florida Center for Nursing to make expenditures supported by
2153grants and donations.
2154 Section 37. Paragraph (a) of subsection (1) of section
2155409.9201, Florida Statutes, is amended to read:
2156 409.9201 Medicaid fraud.-
2157 (1) As used in this section, the term:
2158 (a) "Prescription drug" means any drug, including, but not
2159limited to, finished dosage forms or active ingredients that are
2160subject to, defined by, or described by s. 503(b) of the Federal
2161Food, Drug, and Cosmetic Act or by s. 465.003(8), s.
2162499.003(46)(45) or (53) (52), or s. 499.007(13).
2163
2164The value of individual items of the legend drugs or goods or
2165services involved in distinct transactions committed during a
2166single scheme or course of conduct, whether involving a single
2167person or several persons, may be aggregated when determining
2168the punishment for the offense.
2169 Section 38. Subsection (3) of section 465.0265, Florida
2170Statutes, is amended to read:
2171 465.0265 Centralized prescription filling.-
2172 (3) The filling, delivery, and return of a prescription by
2173one pharmacy for another pursuant to this section shall not be
2174construed as the filling of a transferred prescription as set
2175forth in s. 465.026 or as a wholesale distribution as set forth
2176in s. 499.003(54)(53).
2177 Section 39. Paragraph (g) of subsection (2) of section
2178499.01, Florida Statutes, are amended to read:
2179 499.01 Permits.-
2180 (2) The following permits are established:
2181 (g) Restricted prescription drug distributor permit.-A
2182restricted prescription drug distributor permit is required for
2183any person that engages in the distribution of a prescription
2184drug, which distribution is not considered "wholesale
2185distribution" under s. 499.003(54)(53)(a).
2186 1. A person who engages in the receipt or distribution of
2187a prescription drug in this state for the purpose of processing
2188its return or its destruction must obtain a permit as a
2189restricted prescription drug distributor if such person is not
2190the person initiating the return, the prescription drug
2191wholesale supplier of the person initiating the return, or the
2192manufacturer of the drug.
2193 2. Storage, handling, and recordkeeping of these
2194distributions must comply with the requirements for wholesale
2195distributors under s. 499.0121, but not those set forth in s.
2196499.01212.
2197 3. A person who applies for a permit as a restricted
2198prescription drug distributor, or for the renewal of such a
2199permit, must provide to the department the information required
2200under s. 499.012.
2201 4. The department may adopt rules regarding the
2202distribution of prescription drugs by hospitals, health care
2203entities, charitable organizations, or other persons not
2204involved in wholesale distribution, which rules are necessary
2205for the protection of the public health, safety, and welfare.
2206 Section 40. Paragraph (d) of subsection (4) of section
2207499.0121, Florida Statutes, is amended to read:
2208 499.0121 Storage and handling of prescription drugs;
2209recordkeeping.-The department shall adopt rules to implement
2210this section as necessary to protect the public health, safety,
2211and welfare. Such rules shall include, but not be limited to,
2212requirements for the storage and handling of prescription drugs
2213and for the establishment and maintenance of prescription drug
2214distribution records.
2215 (4) EXAMINATION OF MATERIALS AND RECORDS.-
2216 (d) Upon receipt, a wholesale distributor must review
2217records required under this section for the acquisition of
2218prescription drugs for accuracy and completeness, considering
2219the total facts and circumstances surrounding the transactions
2220and the wholesale distributors involved. This includes
2221authenticating each transaction listed on a pedigree paper, as
2222defined in s. 499.003(37)(36).
2223 Section 41. Paragraphs (a) and (b) of subsection (2) of
2224section 499.01211, Florida Statutes, are amended to read:
2225 499.01211 Drug Wholesale Distributor Advisory Council.-
2226 (2) The State Surgeon General, or his or her designee, and
2227the Secretary of Health Care Administration, or her or his
2228designee, shall be members of the council. The State Surgeon
2229General shall appoint nine additional members to the council who
2230shall be appointed to a term of 4 years each, as follows:
2231 (a) Three different persons each of whom is employed by a
2232different prescription drug wholesale distributor licensed under
2233this part which operates nationally and is a primary wholesale
2234distributor, as defined in s. 499.003(47)(46).
2235 (b) One person employed by a prescription drug wholesale
2236distributor licensed under this part which is a secondary
2237wholesale distributor, as defined in s. 499.003(52)(51).
2238 Section 42. Subsection (1) of section 499.03, Florida
2239Statutes, is amended to read:
2240 499.03 Possession of certain drugs without prescriptions
2241unlawful; exemptions and exceptions.-
2242 (1) A person may not possess, or possess with intent to
2243sell, dispense, or deliver, any habit-forming, toxic, harmful,
2244or new drug subject to s. 499.003(33)(32), or prescription drug
2245as defined in s. 499.003(43)(42), unless the possession of the
2246drug has been obtained by a valid prescription of a practitioner
2247licensed by law to prescribe the drug. However, this section
2248does not apply to the delivery of such drugs to persons included
2249in any of the classes named in this subsection, or to the agents
2250or employees of such persons, for use in the usual course of
2251their businesses or practices or in the performance of their
2252official duties, as the case may be; nor does this section apply
2253to the possession of such drugs by those persons or their agents
2254or employees for such use:
2255 (a) A licensed pharmacist or any person under the licensed
2256pharmacist's supervision while acting within the scope of the
2257licensed pharmacist's practice;
2258 (b) A licensed practitioner authorized by law to prescribe
2259prescription drugs or any person under the licensed
2260practitioner's supervision while acting within the scope of the
2261licensed practitioner's practice;
2262 (c) A qualified person who uses prescription drugs for
2263lawful research, teaching, or testing, and not for resale;
2264 (d) A licensed hospital or other institution that procures
2265such drugs for lawful administration or dispensing by
2266practitioners;
2267 (e) An officer or employee of a federal, state, or local
2268government; or
2269 (f) A person that holds a valid permit issued by the
2270department pursuant to this part which authorizes that person to
2271possess prescription drugs.
2272 Section 43. Paragraphs (i) and (m) of subsection (1) of
2273section 499.05, Florida Statutes, are amended to read:
2274 499.05 Rules.-
2275 (1) The department shall adopt rules to implement and
2276enforce this part with respect to:
2277 (i) Additional conditions that qualify as an emergency
2278medical reason under s. 499.003(54)(53)(b)2.
2279 (m) The recordkeeping, storage, and handling with respect
2280to each of the distributions of prescription drugs specified in
2281s. 499.003(54)(53)(a)-(d).
2282 Section 44. Subsection (1) of section 794.075, Florida
2283Statutes, is amended to read:
2284 794.075 Sexual predators; erectile dysfunction drugs.-
2285 (1) A person may not possess a prescription drug, as
2286defined in s. 499.003(43)(42), for the purpose of treating
2287erectile dysfunction if the person is designated as a sexual
2288predator under s. 775.21.
2289 Section 45. Except as otherwise expressly provided in this
2290act, this act shall take effect July 1, 2010.
CODING: Words stricken are deletions; words underlined are additions.
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