| 1 | A bill to be entitled |
| 2 | An act relating to the Department of Health; amending s. |
| 3 | 20.435, F.S.; revising provisions for administration and |
| 4 | use of funds in the Administrative Trust Fund and the |
| 5 | Emergency Medical Services Trust Fund; providing for such |
| 6 | administration and use under specified provisions; |
| 7 | amending ss. 318.14, 318.18, and 318.21, F.S.; providing |
| 8 | that funds collected from disposition of certain motor |
| 9 | vehicle infractions shall be deposited into the Emergency |
| 10 | Medical Services Trust Fund; removing provisions for |
| 11 | deposit of such funds into the Administrative Trust Fund; |
| 12 | providing for use of the funds; correcting a reference; |
| 13 | amending ss. 320.131, 327.35, 381.765, and 938.07, F.S.; |
| 14 | correcting references to the Brain and Spinal Cord Injury |
| 15 | Program Trust Fund; amending ss. 381.78 and 381.79, F.S.; |
| 16 | correcting references; amending s. 395.403, F.S., relating |
| 17 | to reimbursement of trauma centers; revising eligibility |
| 18 | provisions to remove provisional trauma centers and |
| 19 | certain hospitals; providing for payments to be made from |
| 20 | the Emergency Medical Services Trust Fund; removing |
| 21 | provisions for one-time payments from the Administrative |
| 22 | Trust Fund; amending s. 395.4036, F.S.; providing for use |
| 23 | of funds in the Emergency Medical Services Trust Fund for |
| 24 | verified trauma centers; removing provisions for such use |
| 25 | of funds in the Administrative Trust Fund; reenacting and |
| 26 | amending s. 215.5602, F.S., relating to James and Esther |
| 27 | King Biomedical Research Program; specifying that a |
| 28 | certain amount of the revenue deposited into the Health |
| 29 | Care Trust Fund be reserved for tobacco-related and |
| 30 | cancer-related research; providing for specified amounts |
| 31 | of revenue to be appropriated to the James and Esther King |
| 32 | Biomedical Research Program, the William G. "Bill" |
| 33 | Bankhead, Jr., and David Coley Cancer Research Program, |
| 34 | and the H. Lee Moffitt Cancer Center and Research |
| 35 | Institute; deleting obsolete language; reenacting and |
| 36 | amending s. 381.922, F.S., relating to William G. "Bill" |
| 37 | Bankhead, Jr., and David Coley Cancer Research Program; |
| 38 | providing that the program give emphasis to certain goals; |
| 39 | specifying sources of funding for the program; providing |
| 40 | for a portion of the funds to be made available to the |
| 41 | Florida Center for Universal Research to Eradicate |
| 42 | Disease; deleting obsolete language; amending s. 20.43, |
| 43 | F.S.; removing a provision authorizing division directors |
| 44 | in the Department of Health to appoint certain committees; |
| 45 | prohibiting the department from establishing new programs |
| 46 | or modifying current programs without legislative |
| 47 | approval; requiring the department to notify the Governor |
| 48 | and the Legislature before applying for continuation of or |
| 49 | new federal or private grants over a specified amount; |
| 50 | providing for content of the notification; amending s. |
| 51 | 381.0011, F.S.; requiring the department to manage |
| 52 | emergency preparedness and disaster response functions; |
| 53 | amending s. 381.006, F.S.; revising the definition of the |
| 54 | term "group care facility"; revising rulemaking authority; |
| 55 | amending s. 381.0072, F.S.; revising the definition of the |
| 56 | term "food service establishment"; authorizing the |
| 57 | department to advise and consult with other agencies |
| 58 | concerning the provision of food services; revising |
| 59 | entities that are exempt from rules developed for manager |
| 60 | certification; repealing ss. 411.23, 411.231, and 411.232, |
| 61 | F.S., relating to the Children's Early Investment Program; |
| 62 | amending ss. 411.01 and 411.224, F.S.; conforming |
| 63 | provisions to changes made by the act; amending s. |
| 64 | 499.003, F.S.; defining the term "medical convenience kit" |
| 65 | for purposes of the Florida Drug and Cosmetic Act; |
| 66 | correcting cross-references; amending s. 499.01, F.S.; |
| 67 | providing exceptions from requirements for a device |
| 68 | manufacturer permit; amending s. 499.01212, F.S.; |
| 69 | exempting wholesale distribution of prescription drugs |
| 70 | within a medical convenience kit from requirements for the |
| 71 | wholesaler to provide a pedigree paper if certain |
| 72 | conditions are met; providing that the exemption does not |
| 73 | apply to a kit containing certain controlled substances; |
| 74 | amending s. 509.013, F.S.; revising exclusions to the |
| 75 | definition of the terms "public lodging establishment" and |
| 76 | "public food service establishment" to provide for certain |
| 77 | facilities certified or licensed by the Agency for Health |
| 78 | Care Administration or the Department of Children and |
| 79 | Family Services; requiring the department to develop a |
| 80 | plan to provide tuberculosis services; requiring the |
| 81 | department to submit the plan to the Governor and |
| 82 | Legislature by a specified date; providing plan elements; |
| 83 | transferring and reassigning certain functions and |
| 84 | responsibilities, including records, personnel, property, |
| 85 | and unexpended balances of appropriations and other |
| 86 | resources, from the Department of Health to the Department |
| 87 | of Business and Professional Regulation by a type two |
| 88 | transfer; providing for the continued validity of pending |
| 89 | judicial or administrative actions to which the Department |
| 90 | of Health is a party; providing for the continued validity |
| 91 | of lawful orders issued by the Department of Health; |
| 92 | transferring rules created by the Department of Health to |
| 93 | the Department of Business and Professional Regulation; |
| 94 | providing for the continued validity of permits and |
| 95 | certifications issued by the Department of Health; |
| 96 | amending s. 381.0403, F.S., deleting provisions relating |
| 97 | to the program for graduate medical education innovations |
| 98 | and the graduate medical education committee and report; |
| 99 | conforming a cross-reference; amending s. 381.4018, F.S.; |
| 100 | revising provisions for physician workforce assessment and |
| 101 | development; providing definitions; creating the Physician |
| 102 | Workforce Advisory Council; providing for membership and |
| 103 | organization; providing duties of the council; amending |
| 104 | ss. 458.3192 and 459.0082, F.S.; revising provisions for |
| 105 | analysis by the department of physician surveys under |
| 106 | specified provisions; amending s. 458.315; revising |
| 107 | provisions for issuance by the Board of Medicine of a |
| 108 | temporary certificate to practice medicine in certain |
| 109 | areas; creating s. 459.0076, F.S.; providing for issuance |
| 110 | by the Board of Osteopathic Medicine of a temporary |
| 111 | certificate to practice osteopathic medicine in certain |
| 112 | areas; directing the department to conduct an evaluation |
| 113 | and justification review of its divisions; providing |
| 114 | review requirements; requiring the department to submit a |
| 115 | report to the Governor, the Legislature, and the State |
| 116 | Surgeon General by a specified date; amending s. |
| 117 | 381.00315, F.S.; directing the Department of Health to |
| 118 | accept funds from counties, municipalities, and certain |
| 119 | other entities for the purchase of certain products made |
| 120 | available under a contract with the United States |
| 121 | Department of Health and Human Services for the |
| 122 | manufacture and delivery of such products in response to a |
| 123 | public health emergency; authorizing the department to |
| 124 | submit a budget amendment requesting additional budget |
| 125 | authority for the Florida Center for Nursing to make |
| 126 | certain expenditures; amending ss. 409.9201, 465.0265, |
| 127 | 499.01, 499.01211, 499.01212, 499.03, 499.05, and 794.075, |
| 128 | F.S.; correcting cross-references; providing effective |
| 129 | dates. |
| 130 |
|
| 131 | Be 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 |
| 135 | amended to read: |
| 136 | 20.435 Department of Health; trust funds.-The following |
| 137 | trust 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 |
| 140 | shall be administered in accordance with s. 215.32 consist of |
| 141 | regulatory fees such as those pertaining to the |
| 142 | permitting, and inspection of septic tanks, food |
| 143 | sewage, Superfund compliance, solid waste |
| 144 | facilities, mobile home and recreational vehicle park |
| 145 | inspection, other departmental regulatory and health care |
| 146 | programs, and indirect earnings from grants. Funds shall be used |
| 147 | for the purpose of supporting the regulatory activities of the |
| 148 | department and for other such purposes as may be appropriate and |
| 149 | shall be expended only pursuant to legislative appropriation or |
| 150 | an approved amendment to the department's operating budget |
| 151 | pursuant 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 |
| 154 | shall be administered in accordance with ss. 318.14, 318.18, |
| 155 | 318.21, 395.403, and 395.4036 and the provisions of parts I and |
| 156 | II of chapter 401. |
| 157 | Section 2. Subsection (5) of section 318.14, Florida |
| 158 | Statutes, is amended to read: |
| 159 | 318.14 Noncriminal traffic infractions; exception; |
| 160 | procedures.- |
| 161 | (5) Any person electing to appear before the designated |
| 162 | official or who is required so to appear shall be deemed to have |
| 163 | waived his or her right to the civil penalty provisions of s. |
| 164 | 318.18. The official, after a hearing, shall make a |
| 165 | determination as to whether an infraction has been committed. If |
| 166 | the commission of an infraction has been proven, the official |
| 167 | may impose a civil penalty not to exceed $500, except that in |
| 168 | cases involving unlawful speed in a school zone or involving |
| 169 | unlawful speed in a construction zone, the civil penalty may not |
| 170 | exceed $1,000; or require attendance at a driver improvement |
| 171 | school, or both. If the person is required to appear before the |
| 172 | designated official pursuant to s. 318.19(1) and is found to |
| 173 | have committed the infraction, the designated official shall |
| 174 | impose a civil penalty of $1,000 in addition to any other |
| 175 | penalties and the person's driver's license shall be suspended |
| 176 | for 6 months. If the person is required to appear before the |
| 177 | designated official pursuant to s. 318.19(2) and is found to |
| 178 | have committed the infraction, the designated official shall |
| 179 | impose a civil penalty of $500 in addition to any other |
| 180 | penalties and the person's driver's license shall be suspended |
| 181 | for 3 months. If the official determines that no infraction has |
| 182 | been committed, no costs or penalties shall be imposed and any |
| 183 | costs or penalties that have been paid shall be returned. Moneys |
| 184 | received from the mandatory civil penalties imposed pursuant to |
| 185 | this subsection upon persons required to appear before a |
| 186 | designated official pursuant to s. 318.19(1) or (2) shall be |
| 187 | remitted to the Department of Revenue and deposited into the |
| 188 | Department of Health Emergency Medical Services Administrative |
| 189 | Trust Fund to provide financial support to certified trauma |
| 190 | centers to assure the availability and accessibility of trauma |
| 191 | services throughout the state. Funds deposited into the |
| 192 | Emergency Medical Services Administrative Trust Fund under this |
| 193 | section shall be allocated as follows: |
| 194 | (a) Fifty percent shall be allocated equally among all |
| 195 | Level I, Level II, and pediatric trauma centers in recognition |
| 196 | of readiness costs for maintaining trauma services. |
| 197 | (b) Fifty percent shall be allocated among Level I, Level |
| 198 | II, and pediatric trauma centers based on each center's relative |
| 199 | volume of trauma cases as reported in the Department of Health |
| 200 | Trauma Registry. |
| 201 | Section 3. Paragraph (h) of subsection (3), paragraph (c) |
| 202 | of subsection (5), and subsection (20) of section 318.18, |
| 203 | Florida Statutes, are amended to read: |
| 204 | 318.18 Amount of penalties.-The penalties required for a |
| 205 | noncriminal disposition pursuant to s. 318.14 or a criminal |
| 206 | offense listed in s. 318.17 are as follows: |
| 207 | (3) |
| 208 | (h) A person cited for a second or subsequent conviction |
| 209 | of speed exceeding the limit by 30 miles per hour and above |
| 210 | within a 12-month period shall pay a fine that is double the |
| 211 | amount listed in paragraph (b). For purposes of this paragraph, |
| 212 | the term "conviction" means a finding of guilt as a result of a |
| 213 | jury verdict, nonjury trial, or entry of a plea of guilty. |
| 214 | Moneys received from the increased fine imposed by this |
| 215 | paragraph shall be remitted to the Department of Revenue and |
| 216 | deposited into the Department of Health Emergency Medical |
| 217 | Services Administrative Trust Fund to provide financial support |
| 218 | to certified trauma centers to assure the availability and |
| 219 | accessibility of trauma services throughout the state. Funds |
| 220 | deposited into the Emergency Medical Services Administrative |
| 221 | Trust Fund under this section shall be allocated as follows: |
| 222 | 1. Fifty percent shall be allocated equally among all |
| 223 | Level I, Level II, and pediatric trauma centers in recognition |
| 224 | of readiness costs for maintaining trauma services. |
| 225 | 2. Fifty percent shall be allocated among Level I, Level |
| 226 | II, and pediatric trauma centers based on each center's relative |
| 227 | volume of trauma cases as reported in the Department of Health |
| 228 | Trauma Registry. |
| 229 | (5) |
| 230 | (c) In addition to the penalty under paragraph (a) or |
| 231 | paragraph (b), $65 for a violation of s. 316.172(1)(a) or (b). |
| 232 | If the alleged offender is found to have committed the offense, |
| 233 | the court shall impose the civil penalty under paragraph (a) or |
| 234 | paragraph (b) plus an additional $65. The additional $65 |
| 235 | collected under this paragraph shall be remitted to the |
| 236 | Department of Revenue for deposit into the Emergency Medical |
| 237 | Services Administrative Trust Fund of the Department of Health |
| 238 | to be used as provided in s. 395.4036. |
| 239 | (20) In addition to any other penalty, $65 for a violation |
| 240 | of s. 316.191, prohibiting racing on highways, or s. 316.192, |
| 241 | prohibiting reckless driving. The additional $65 collected under |
| 242 | this subsection shall be remitted to the Department of Revenue |
| 243 | for deposit into the Emergency Medical Services Administrative |
| 244 | Trust Fund of the Department of Health to be used as provided in |
| 245 | s. 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.- |
| 249 | All civil penalties received by a county court pursuant to the |
| 250 | provisions of this chapter shall be distributed and paid monthly |
| 251 | as follows: |
| 252 | (2) Of the remainder: |
| 253 | (d) Eight and two-tenths percent shall be remitted to the |
| 254 | Department of Revenue for deposit in the Brain and Spinal Cord |
| 255 | Injury Program Rehabilitation Trust Fund for the purposes set |
| 256 | forth in s. 381.79. |
| 257 | (15) Of the additional fine assessed under s. 318.18(3)(e) |
| 258 | for a violation of s. 316.1893, 50 percent of the moneys |
| 259 | received from the fines shall be appropriated to the Agency for |
| 260 | Health Care Administration as general revenue to provide an |
| 261 | enhanced Medicaid payment to nursing homes that serve Medicaid |
| 262 | recipients with brain and spinal cord injuries. The remaining 50 |
| 263 | percent of the moneys received from the enhanced fine imposed |
| 264 | under s. 318.18(3)(e) shall be remitted to the Department of |
| 265 | Revenue and deposited into the Department of Health Emergency |
| 266 | Medical Services Administrative Trust Fund to provide financial |
| 267 | support to certified trauma centers in the counties where |
| 268 | enhanced penalty zones are established to ensure the |
| 269 | availability and accessibility of trauma services. Funds |
| 270 | deposited into the Emergency Medical Services Administrative |
| 271 | Trust Fund under this subsection shall be allocated as follows: |
| 272 | (a) Fifty percent shall be allocated equally among all |
| 273 | Level I, Level II, and pediatric trauma centers in recognition |
| 274 | of readiness costs for maintaining trauma services. |
| 275 | (b) Fifty percent shall be allocated among Level I, Level |
| 276 | II, and pediatric trauma centers based on each center's relative |
| 277 | volume of trauma cases as reported in the Department of Health |
| 278 | Trauma Registry. |
| 279 | Section 5. Subsection (2) of section 320.131, Florida |
| 280 | Statutes, is amended to read: |
| 281 | 320.131 Temporary tags.- |
| 282 | (2) The department is authorized to sell temporary tags, |
| 283 | in addition to those listed above, to their agents and where |
| 284 | need is demonstrated by a consumer complainant. The fee shall be |
| 285 | $2 each. One dollar from each tag sold shall be deposited into |
| 286 | the Brain and Spinal Cord Injury Program Rehabilitation Trust |
| 287 | Fund, with the remaining proceeds being deposited into the |
| 288 | Highway Safety Operating Trust Fund. Agents of the department |
| 289 | shall sell temporary tags for $2 each and shall charge the |
| 290 | service charge authorized by s. 320.04 per transaction, |
| 291 | regardless of the quantity sold. Requests for purchase of |
| 292 | temporary tags to the department or its agents shall be made, |
| 293 | where applicable, on letterhead stationery and notarized. Except |
| 294 | as specifically provided otherwise, a temporary tag shall be |
| 295 | valid for 30 days, and no more than two shall be issued to the |
| 296 | same person for the same vehicle. |
| 297 | Section 6. Subsection (9) of section 327.35, Florida |
| 298 | Statutes, is amended to read: |
| 299 | 327.35 Boating under the influence; penalties; "designated |
| 300 | drivers".- |
| 301 | (9) Notwithstanding any other provision of this section, |
| 302 | for any person convicted of a violation of subsection (1), in |
| 303 | addition to the fines set forth in subsections (2) and (4), an |
| 304 | additional fine of $60 shall be assessed and collected in the |
| 305 | same manner as the fines set forth in subsections (2) and (4). |
| 306 | All fines collected under this subsection shall be remitted by |
| 307 | the clerk of the court to the Department of Revenue for deposit |
| 308 | into the Brain and Spinal Cord Injury Program Rehabilitation |
| 309 | Trust Fund and used for the purposes set forth in |
| 310 | after 5 percent is deducted therefrom by the clerk of |
| 311 | for administrative costs. |
| 312 | Section 7. Subsection (2) of section 381.765, Florida |
| 313 | Statutes, 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 |
| 316 | acquired in operating the brain and spinal cord injury program |
| 317 | when they are no longer necessary or exchange them for necessary |
| 318 | items that may be used to greater advantage. When any such |
| 319 | surplus equipment is sold or exchanged, a receipt for the |
| 320 | equipment shall be taken from the purchaser showing the |
| 321 | consideration given for such equipment and forwarded to the |
| 322 | Chief Financial Officer, and any funds received by the brain and |
| 323 | spinal cord injury program pursuant to any such transaction |
| 324 | shall be deposited in the Brain and Spinal Cord Injury Program |
| 325 | Rehabilitation Trust Fund and shall be available for expenditure |
| 326 | for any purpose consistent with ss. 381.739-381.79 this part. |
| 327 | Section 8. Subsection (7) of section 381.78, Florida |
| 328 | Statutes, is amended to read: |
| 329 | 381.78 Advisory council on brain and spinal cord |
| 330 | injuries.- |
| 331 | (7) A member of the advisory council may be removed from |
| 332 | office by the State Surgeon General for malfeasance, |
| 333 | misfeasance, neglect of duty, incompetence, or permanent |
| 334 | inability to perform official duties or for pleading nolo |
| 335 | contendere to, or being found guilty of, a crime. Malfeasance |
| 336 | includes, but is not limited to, a violation of any specific |
| 337 | prohibition within ss. 381.739-381.79 this part. |
| 338 | Section 9. Subsection (6) of section 381.79, Florida |
| 339 | Statutes, 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 |
| 342 | fund, and use for carrying out the purposes of ss. 381.739- |
| 343 | 381.79 this part gifts made unconditionally by will or |
| 344 | otherwise. Any gift made under conditions that, in the judgment |
| 345 | of the department, are proper and consistent with this section, |
| 346 | the laws of the United States, and the laws of this state may be |
| 347 | accepted and shall be held, invested, reinvested, and used in |
| 348 | accordance with the conditions of the gift. |
| 349 | Section 10. Subsections (1) and (2) of section 395.403, |
| 350 | Florida Statutes, are amended to read: |
| 351 | 395.403 Reimbursement of trauma centers.- |
| 352 | (1) All provisional trauma centers and trauma centers |
| 353 | shall be considered eligible to receive state funding when state |
| 354 | funds are specifically appropriated for state-sponsored trauma |
| 355 | centers in the General Appropriations Act. Effective July 1, |
| 356 | 2010 2004, the department shall make one-time payments from the |
| 357 | Emergency Medical Services Administrative Trust Fund under s. |
| 358 | 20.435 to the trauma centers and a hospital with a pending |
| 359 | application for a Level I trauma center in recognition of the |
| 360 | capital investment made by the hospital to establish the trauma |
| 361 | service. Payments shall be in equal amounts for the trauma |
| 362 | centers approved by the department as of July 1 of the fiscal |
| 363 | year in which funding is appropriated, with lesser amounts for |
| 364 | the hospital with an application pending for a Level I trauma |
| 365 | center at the department as of April 1, 2004. In the event a |
| 366 | trauma center does not maintain its status as a trauma center |
| 367 | for any state fiscal year in which such funding is appropriated, |
| 368 | the provisional trauma center or trauma center shall repay the |
| 369 | state for the portion of the year during which it was not a |
| 370 | trauma center. |
| 371 | (2) Provisional trauma centers and Trauma centers eligible |
| 372 | to receive distributions from the Emergency Medical Services |
| 373 | Administrative Trust Fund under s. 20.435 in accordance with |
| 374 | subsection (1) may request that such funds be used as |
| 375 | intergovernmental transfer funds in the Medicaid program. |
| 376 | Section 11. Subsections (1) and (2) of section 395.4036, |
| 377 | Florida Statutes, are amended to read: |
| 378 | 395.4036 Trauma payments.- |
| 379 | (1) Recognizing the Legislature's stated intent to provide |
| 380 | financial support to the current verified trauma centers and to |
| 381 | provide incentives for the establishment of additional trauma |
| 382 | centers as part of a system of state-sponsored trauma centers, |
| 383 | the department shall utilize funds collected under s. 318.18 and |
| 384 | deposited into the Emergency Medical Services Administrative |
| 385 | Trust Fund of the department to ensure the availability and |
| 386 | accessibility of trauma services throughout the state as |
| 387 | provided in this subsection. |
| 388 | (a) Funds collected under s. 318.18(15) shall be |
| 389 | distributed as follows: |
| 390 | 1. Twenty percent of the total funds collected during the |
| 391 | state fiscal year shall be distributed to verified trauma |
| 392 | centers that have a local funding contribution as of December |
| 393 | 31. Distribution of funds under this subparagraph shall be based |
| 394 | on trauma caseload volume for the most recent calendar year |
| 395 | available. |
| 396 | 2. Forty percent of the total funds collected shall be |
| 397 | distributed to verified trauma centers based on trauma caseload |
| 398 | volume for the most recent calendar year available. The |
| 399 | determination of caseload volume for distribution of funds under |
| 400 | this subparagraph shall be based on the department's Trauma |
| 401 | Registry data. |
| 402 | 3. Forty percent of the total funds collected shall be |
| 403 | distributed to verified trauma centers based on severity of |
| 404 | trauma patients for the most recent calendar year available. The |
| 405 | determination of severity for distribution of funds under this |
| 406 | subparagraph shall be based on the department's International |
| 407 | Classification Injury Severity Scores or another statistically |
| 408 | valid and scientifically accepted method of stratifying a trauma |
| 409 | patient's severity of injury, risk of mortality, and resource |
| 410 | consumption as adopted by the department by rule, weighted based |
| 411 | on the costs associated with and incurred by the trauma center |
| 412 | in treating trauma patients. The weighting of scores shall be |
| 413 | established by the department by rule. |
| 414 | (b) Funds collected under s. 318.18(5)(c) and (19) shall |
| 415 | be distributed as follows: |
| 416 | 1. Thirty percent of the total funds collected shall be |
| 417 | distributed to Level II trauma centers operated by a public |
| 418 | hospital governed by an elected board of directors as of |
| 419 | December 31, 2008. |
| 420 | 2. Thirty-five percent of the total funds collected shall |
| 421 | be distributed to verified trauma centers based on trauma |
| 422 | caseload volume for the most recent calendar year available. The |
| 423 | determination of caseload volume for distribution of funds under |
| 424 | this subparagraph shall be based on the department's Trauma |
| 425 | Registry data. |
| 426 | 3. Thirty-five percent of the total funds collected shall |
| 427 | be distributed to verified trauma centers based on severity of |
| 428 | trauma patients for the most recent calendar year available. The |
| 429 | determination of severity for distribution of funds under this |
| 430 | subparagraph shall be based on the department's International |
| 431 | Classification Injury Severity Scores or another statistically |
| 432 | valid and scientifically accepted method of stratifying a trauma |
| 433 | patient's severity of injury, risk of mortality, and resource |
| 434 | consumption as adopted by the department by rule, weighted based |
| 435 | on the costs associated with and incurred by the trauma center |
| 436 | in treating trauma patients. The weighting of scores shall be |
| 437 | established by the department by rule. |
| 438 | (2) Funds deposited in the department's Emergency Medical |
| 439 | Services Administrative Trust Fund for verified trauma centers |
| 440 | may be used to maximize the receipt of federal funds that may be |
| 441 | available for such trauma centers. Notwithstanding this section |
| 442 | and s. 318.14, distributions to trauma centers may be adjusted |
| 443 | in a manner to ensure that total payments to trauma centers |
| 444 | represent the same proportional allocation as set forth in this |
| 445 | section and s. 318.14. For purposes of this section and s. |
| 446 | 318.14, total funds distributed to trauma centers may include |
| 447 | revenue from the Emergency Medical Services Administrative Trust |
| 448 | Fund and federal funds for which revenue from the Administrative |
| 449 | Trust Fund is used to meet state or local matching requirements. |
| 450 | Funds collected under ss. 318.14 and 318.18 and deposited in the |
| 451 | Emergency Medical Services Administrative Trust Fund of the |
| 452 | department shall be distributed to trauma centers on a quarterly |
| 453 | basis using the most recent calendar year data available. Such |
| 454 | data shall not be used for more than four quarterly |
| 455 | distributions unless there are extenuating circumstances as |
| 456 | determined by the department, in which case the most recent |
| 457 | calendar year data available shall continue to be used and |
| 458 | appropriate adjustments shall be made as soon as the more recent |
| 459 | data becomes available. |
| 460 | Section 12. Section 938.07, Florida Statutes, is amended to |
| 461 | read: |
| 462 | 938.07 Driving or boating under the influence.- |
| 463 | Notwithstanding any other provision of s. 316.193 or s. 327.35, |
| 464 | a court cost of $135 shall be added to any fine imposed pursuant |
| 465 | to s. 316.193 or s. 327.35. The clerks shall remit the funds to |
| 466 | the Department of Revenue, $25 of which shall be deposited in |
| 467 | the Emergency Medical Services Trust Fund, $50 shall be |
| 468 | deposited in the Operating Trust Fund of the Department of Law |
| 469 | Enforcement to be used for operational expenses in conducting |
| 470 | the statewide criminal analysis laboratory system established in |
| 471 | s. 943.32, and $60 shall be deposited in the Brain and Spinal |
| 472 | Cord Injury Program Rehabilitation Trust Fund created in s. |
| 473 | 381.79. |
| 474 | Section 13. Section 215.5602, Florida Statutes, is |
| 475 | reenacted and amended to read: |
| 476 | 215.5602 James and Esther King Biomedical Research |
| 477 | Program.- |
| 478 | (1) There is established within the Department of Health |
| 479 | the James and Esther King Biomedical Research Program funded by |
| 480 | the proceeds of the Lawton Chiles Endowment Fund pursuant to s. |
| 481 | 215.5601. The purpose of the James and Esther King Biomedical |
| 482 | Research Program is to provide an annual and perpetual source of |
| 483 | funding in order to support research initiatives that address |
| 484 | the health care problems of Floridians in the areas of tobacco- |
| 485 | related cancer, cardiovascular disease, stroke, and pulmonary |
| 486 | disease. The long-term goals of the program are to: |
| 487 | (a) Improve the health of Floridians by researching better |
| 488 | prevention, diagnoses, treatments, and cures for cancer, |
| 489 | cardiovascular disease, stroke, and pulmonary disease. |
| 490 | (b) Expand the foundation of biomedical knowledge relating |
| 491 | to the prevention, diagnosis, treatment, and cure of diseases |
| 492 | related to tobacco use, including cancer, cardiovascular |
| 493 | disease, stroke, and pulmonary disease. |
| 494 | (c) Improve the quality of the state's academic health |
| 495 | centers by bringing the advances of biomedical research into the |
| 496 | training of physicians and other health care providers. |
| 497 | (d) Increase the state's per capita funding for research |
| 498 | by undertaking new initiatives in public health and biomedical |
| 499 | research that will attract additional funding from outside the |
| 500 | state. |
| 501 | (e) Stimulate economic activity in the state in areas |
| 502 | related to biomedical research, such as the research and |
| 503 | production of pharmaceuticals, biotechnology, and medical |
| 504 | devices. |
| 505 | (2) Funds appropriated for the James and Esther King |
| 506 | Biomedical Research Program shall be used exclusively for the |
| 507 | award of grants and fellowships as established in this section; |
| 508 | for research relating to the prevention, diagnosis, treatment, |
| 509 | and cure of diseases related to tobacco use, including cancer, |
| 510 | cardiovascular disease, stroke, and pulmonary disease; and for |
| 511 | expenses incurred in the administration of this section. |
| 512 | Priority shall be granted to research designed to prevent or |
| 513 | cure disease. |
| 514 | (3) There is created within the Department of Health the |
| 515 | Biomedical Research Advisory Council. |
| 516 | (a) The council shall consist of 11 members, including: |
| 517 | the chief executive officer of the Florida Division of the |
| 518 | American Cancer Society, or a designee; the chief executive |
| 519 | officer of the Florida/Puerto Rico Affiliate of the American |
| 520 | Heart Association, or a designee; and the chief executive |
| 521 | officer of the American Lung Association of Florida, or a |
| 522 | designee. The remaining 8 members of the council shall be |
| 523 | appointed as follows: |
| 524 | 1. The Governor shall appoint four members, two members |
| 525 | with expertise in the field of biomedical research, one member |
| 526 | from a research university in the state, and one member |
| 527 | representing the general population of the state. |
| 528 | 2. The President of the Senate shall appoint two members, |
| 529 | one member with expertise in the field of behavioral or social |
| 530 | research and one representative from a cancer program approved |
| 531 | by the American College of Surgeons. |
| 532 | 3. The Speaker of the House of Representatives shall |
| 533 | appoint two members, one member from a professional medical |
| 534 | organization and one representative from a cancer program |
| 535 | approved by the American College of Surgeons. |
| 536 |
|
| 537 | In making these appointments, the Governor, the President of the |
| 538 | Senate, and the Speaker of the House of Representatives shall |
| 539 | select primarily, but not exclusively, Floridians with |
| 540 | biomedical and lay expertise in the general areas of cancer, |
| 541 | cardiovascular disease, stroke, and pulmonary disease. The |
| 542 | appointments shall be for a 3-year term and shall reflect the |
| 543 | diversity of the state's population. An appointed member may not |
| 544 | serve more than two consecutive terms. |
| 545 | (b) The council shall adopt internal organizational |
| 546 | procedures as necessary for its efficient organization. |
| 547 | (c) The department shall provide such staff, information, |
| 548 | and other assistance as is reasonably necessary to assist the |
| 549 | council in carrying out its responsibilities. |
| 550 | (d) Members of the council shall serve without |
| 551 | compensation, but may receive reimbursement as provided in s. |
| 552 | 112.061 for travel and other necessary expenses incurred in the |
| 553 | performance of their official duties. |
| 554 | (4) The council shall advise the State Surgeon General as |
| 555 | to the direction and scope of the biomedical research program. |
| 556 | The responsibilities of the council may include, but are not |
| 557 | limited 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 |
| 562 | fairness, neutrality, and adherence to the principles of merit |
| 563 | and quality in the conduct of the program. |
| 564 | (e) Assisting in the development of appropriate linkages |
| 565 | to nonacademic entities, such as voluntary organizations, health |
| 566 | care delivery institutions, industry, government agencies, and |
| 567 | public officials. |
| 568 | (f) Developing criteria and standards for the award of |
| 569 | research grants. |
| 570 | (g) Developing administrative procedures relating to |
| 571 | solicitation, review, and award of research grants and |
| 572 | fellowships, to ensure an impartial, high-quality peer review |
| 573 | system. |
| 574 | (h) Developing and supervising research peer review |
| 575 | panels. |
| 576 | (i) Reviewing reports of peer review panels and making |
| 577 | recommendations for research grants and fellowships. |
| 578 | (j) Developing and providing oversight regarding |
| 579 | mechanisms for the dissemination of research results. |
| 580 | (5)(a) Applications for biomedical research funding under |
| 581 | the program may be submitted from any university or established |
| 582 | research institute in the state. All qualified investigators in |
| 583 | the state, regardless of institution affiliation, shall have |
| 584 | equal access and opportunity to compete for the research |
| 585 | funding. |
| 586 | (b) Grants and fellowships shall be awarded by the State |
| 587 | Surgeon General, after consultation with the council, on the |
| 588 | basis of scientific merit, as determined by an open competitive |
| 589 | peer review process that ensures objectivity, consistency, and |
| 590 | high quality. The following types of applications shall be |
| 591 | considered 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 |
| 596 | appropriate and are evaluated fairly on the basis of scientific |
| 597 | merit, the State Surgeon General, in consultation with the |
| 598 | council, shall appoint a peer review panel of independent, |
| 599 | scientifically qualified individuals to review the scientific |
| 600 | content of each proposal and establish its scientific priority |
| 601 | score. The priority scores shall be forwarded to the council and |
| 602 | must be considered in determining which proposals shall be |
| 603 | recommended for funding. |
| 604 | (7) The council and the peer review panel shall establish |
| 605 | and follow rigorous guidelines for ethical conduct and adhere to |
| 606 | a strict policy with regard to conflict of interest. A member of |
| 607 | the council or panel may not participate in any discussion or |
| 608 | decision with respect to a research proposal by any firm, |
| 609 | entity, or agency with which the member is associated as a |
| 610 | member of the governing body or as an employee, or with which |
| 611 | the member has entered into a contractual arrangement. Meetings |
| 612 | of the council and the peer review panels shall be subject to |
| 613 | the provisions of chapter 119, s. 286.011, and s. 24, Art. I of |
| 614 | the State Constitution. |
| 615 | (8) The department may contract on a competitive-bid basis |
| 616 | with an appropriate entity to administer the program. |
| 617 | Administrative expenses may not exceed 15 percent of the total |
| 618 | funds available to the program in any given year. |
| 619 | (9) The department, after consultation with the council, |
| 620 | may adopt rules as necessary to implement this section. |
| 621 | (10) The council shall submit an annual progress report on |
| 622 | the state of biomedical research in this state to the Florida |
| 623 | Center for Universal Research to Eradicate Disease and to the |
| 624 | Governor, the State Surgeon General, the President of the |
| 625 | Senate, and the Speaker of the House of Representatives by |
| 626 | February 1. The report must include: |
| 627 | (a) A list of research projects supported by grants or |
| 628 | fellowships 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 |
| 631 | involving research supported by grants or fellowships awarded |
| 632 | under the program. |
| 633 | (d) The total amount of biomedical research funding |
| 634 | currently flowing into the state. |
| 635 | (e) New grants for biomedical research which were funded |
| 636 | based on research supported by grants or fellowships awarded |
| 637 | under the program. |
| 638 | (f) Progress in the prevention, diagnosis, treatment, and |
| 639 | cure of diseases related to tobacco use, including cancer, |
| 640 | cardiovascular disease, stroke, and pulmonary disease. |
| 641 | (11) The council shall award grants for cancer research |
| 642 | through the William G. "Bill" Bankhead, Jr., and David Coley |
| 643 | Cancer Research Program created in s. 381.922. |
| 644 | (12) From funds appropriated to accomplish the goals of |
| 645 | this section, up to $250,000 shall be available for the |
| 646 | operating costs of the Florida Center for Universal Research to |
| 647 | Eradicate Disease. |
| 648 | (a) Beginning in the 2010-2011 2009-2010 fiscal year and |
| 649 | thereafter, $50 million from 5 percent of the revenue deposited |
| 650 | into the Health Care Trust Fund pursuant to ss. 210.011(9) and |
| 651 | 210.276(7) shall be reserved for research of tobacco-related or |
| 652 | cancer-related illnesses; however, the sum of the revenue |
| 653 | reserved pursuant to ss. 210.011(9) and 210.276(7) may not |
| 654 | exceed $50 million in any fiscal year. Of the revenue deposited |
| 655 | in the Health Care Trust Fund pursuant to this section, $50 |
| 656 | million shall be transferred to the Biomedical Research Trust |
| 657 | Fund within the Department of Health. Subject to annual |
| 658 | appropriations in the General Appropriations Act, $20 million |
| 659 | shall be appropriated to the James and Esther King Biomedical |
| 660 | Research Program, $20 million shall be appropriated to the |
| 661 | William G. "Bill" Bankhead, Jr., and David Coley Cancer Research |
| 662 | Program created under s. 381.922, and $10 million shall be |
| 663 | appropriated to the H. Lee Moffitt Cancer Center and Research |
| 664 | Institute established under s. 1004.43. |
| 665 | (b) In the 2009-2010 fiscal year, 2.5 percent, not to |
| 666 | exceed $25 million, of the revenue deposited into the Health |
| 667 | Care Trust Fund pursuant to this subsection shall be transferred |
| 668 | to the Biomedical Research Trust Fund within the Department of |
| 669 | Health for the James and Esther King Biomedical Research |
| 670 | Program. |
| 671 | (13) By June 1, 2009, the Division of Statutory Revision |
| 672 | of the Office of Legislative Services shall certify to the |
| 673 | President of the Senate and the Speaker of the House of |
| 674 | Representatives the language and statutory citation of this |
| 675 | section, which is scheduled to expire January 1, 2011. |
| 676 | (14) The Legislature shall review the performance, the |
| 677 | outcomes, and the financial management of the James and Esther |
| 678 | King Biomedical Research Program during the 2010 Regular Session |
| 679 | of the Legislature and shall determine the most appropriate |
| 680 | funding source and means of funding the program based on its |
| 681 | review. |
| 682 | (15) This section expires January 1, 2011, unless reviewed |
| 683 | and reenacted by the Legislature before that date. |
| 684 | Section 14. Section 381.922, Florida Statutes, is |
| 685 | reenacted and amended to read: |
| 686 | 381.922 William G. "Bill" Bankhead, Jr., and David Coley |
| 687 | Cancer Research Program.- |
| 688 | (1) The William G. "Bill" Bankhead, Jr., and David Coley |
| 689 | Cancer Research Program, which may be otherwise cited as the |
| 690 | "Bankhead-Coley Program," is created within the Department of |
| 691 | Health. The purpose of the program shall be to advance progress |
| 692 | towards cures for cancer through grants awarded through a peer- |
| 693 | reviewed, competitive process. |
| 694 | (2) The program shall provide grants for cancer research |
| 695 | to further the search for cures for cancer. |
| 696 | (a) Emphasis shall be given to the following goals |
| 697 | enumerated in s. 381.921, as those goals support the advancement |
| 698 | of such cures: |
| 699 | 1. Efforts to significantly expand cancer research |
| 700 | capacity in the state by: |
| 701 | a. Identifying ways to attract new research talent and |
| 702 | attendant national grant-producing researchers to cancer |
| 703 | research facilities in this state; |
| 704 | b. Implementing a peer-reviewed, competitive process to |
| 705 | identify and fund the best proposals to expand cancer research |
| 706 | institutes in this state; |
| 707 | c. Funding through available resources for those proposals |
| 708 | that demonstrate the greatest opportunity to attract federal |
| 709 | research grants and private financial support; |
| 710 | d. Encouraging the employment of bioinformatics in order |
| 711 | to create a cancer informatics infrastructure that enhances |
| 712 | information and resource exchange and integration through |
| 713 | researchers working in diverse disciplines, to facilitate the |
| 714 | full spectrum of cancer investigations; |
| 715 | e. Facilitating the technical coordination, business |
| 716 | development, and support of intellectual property as it relates |
| 717 | to the advancement of cancer research; and |
| 718 | f. Aiding in other multidisciplinary research-support |
| 719 | activities as they inure to the advancement of cancer research. |
| 720 | 2. Efforts to improve both research and treatment through |
| 721 | greater participation in clinical trials networks by: |
| 722 | a. Identifying ways to increase adult enrollment in cancer |
| 723 | clinical trials; |
| 724 | b. Supporting public and private professional education |
| 725 | programs designed to increase the awareness and knowledge about |
| 726 | cancer clinical trials; |
| 727 | c. Providing tools to cancer patients and community-based |
| 728 | oncologists to aid in the identification of cancer clinical |
| 729 | trials available in the state; and |
| 730 | d. Creating opportunities for the state's academic cancer |
| 731 | centers to collaborate with community-based oncologists in |
| 732 | cancer clinical trials networks. |
| 733 | 3. Efforts to reduce the impact of cancer on disparate |
| 734 | groups by: |
| 735 | a. Identifying those cancers that disproportionately |
| 736 | impact certain demographic groups; and |
| 737 | b. Building collaborations designed to reduce health |
| 738 | disparities as they relate to cancer. |
| 739 | (b) Preference may be given to grant proposals that foster |
| 740 | collaborations among institutions, researchers, and community |
| 741 | practitioners, as such proposals support the advancement of |
| 742 | cures through basic or applied research, including clinical |
| 743 | trials involving cancer patients and related networks. |
| 744 | (3)(a) Applications for funding for cancer research may be |
| 745 | submitted by any university or established research institute in |
| 746 | the state. All qualified investigators in the state, regardless |
| 747 | of institutional affiliation, shall have equal access and |
| 748 | opportunity to compete for the research funding. Collaborative |
| 749 | proposals, including those that advance the program's goals |
| 750 | enumerated in subsection (2), may be given preference. Grants |
| 751 | shall be awarded by the State Surgeon General, after |
| 752 | consultation with the Biomedical Research Advisory Council, on |
| 753 | the basis of scientific merit, as determined by an open, |
| 754 | competitive peer review process that ensures objectivity, |
| 755 | consistency, and high quality. The following types of |
| 756 | applications shall be considered for funding: |
| 757 | 1. Investigator-initiated research grants. |
| 758 | 2. Institutional research grants. |
| 759 | 3. Collaborative research grants, including those that |
| 760 | advance the finding of cures through basic or applied research. |
| 761 | (b) In order to ensure that all proposals for research |
| 762 | funding are appropriate and are evaluated fairly on the basis of |
| 763 | scientific merit, the State Surgeon General, in consultation |
| 764 | with the council, shall appoint a peer review panel of |
| 765 | independent, scientifically qualified individuals to review the |
| 766 | scientific content of each proposal and establish its priority |
| 767 | score. The priority scores shall be forwarded to the council and |
| 768 | must be considered in determining which proposals shall be |
| 769 | recommended for funding. |
| 770 | (c) The council and the peer review panel shall establish |
| 771 | and follow rigorous guidelines for ethical conduct and adhere to |
| 772 | a strict policy with regard to conflicts of interest. A member |
| 773 | of the council or panel may not participate in any discussion or |
| 774 | decision with respect to a research proposal by any firm, |
| 775 | entity, or agency with which the member is associated as a |
| 776 | member of the governing body or as an employee or with which the |
| 777 | member has entered into a contractual arrangement. Meetings of |
| 778 | the council and the peer review panels are subject to chapter |
| 779 | 119, s. 286.011, and s. 24, Art. I of the State Constitution. |
| 780 | (4) By December 15 of each year, the Department of Health |
| 781 | shall submit to the Governor, the President of the Senate, and |
| 782 | the Speaker of the House of Representatives a report indicating |
| 783 | progress towards the program's mission and making |
| 784 | recommendations that further its purpose. |
| 785 | (5) The William G. "Bill" Bankhead, Jr., and David Coley |
| 786 | Cancer Research Program is funded pursuant to s. 215.5602(12). |
| 787 | Funds appropriated for the William G. "Bill" Bankhead, Jr., and |
| 788 | David Coley Cancer Research Program shall be distributed |
| 789 | pursuant to this section to provide grants to researchers |
| 790 | seeking cures for cancer and cancer-related illnesses, with |
| 791 | emphasis given to the goals enumerated in this section s. |
| 792 | 381.921. From the total funds appropriated, an amount of up to |
| 793 | 10 percent may be used for administrative expenses. From funds |
| 794 | appropriated to accomplish the goals of this section, up to |
| 795 | $250,000 shall be available for the operating costs of the |
| 796 | Florida Center for Universal Research to Eradicate Disease. In |
| 797 | the 2009-2010 fiscal year, 2.5 percent, not to exceed $25 |
| 798 | million, of the revenue deposited into the Health Care Trust |
| 799 | Fund pursuant to s. 215.5602(12)(a) shall be transferred to the |
| 800 | Biomedical Research Trust Fund within the Department of Health |
| 801 | for the William G. "Bill" Bankhead, Jr., and David Coley Cancer |
| 802 | Research Program. |
| 803 | (6) By June 1, 2009, the Division of Statutory Revision of |
| 804 | the Office of Legislative Services shall certify to the |
| 805 | President of the Senate and the Speaker of the House of |
| 806 | Representatives the language and statutory citation of this |
| 807 | section, which is scheduled to expire January 1, 2011. |
| 808 | (7) The Legislature shall review the performance, the |
| 809 | outcomes, and the financial management of the William G. "Bill" |
| 810 | Bankhead, Jr., and David Coley Cancer Research Program during |
| 811 | the 2010 Regular Session of the Legislature and shall determine |
| 812 | the most appropriate funding source and means of funding the |
| 813 | program based on its review. |
| 814 | (8) This section expires January 1, 2011, unless reviewed |
| 815 | and reenacted by the Legislature before that date. |
| 816 | Section 15. Subsection (6) of section 20.43, Florida |
| 817 | Statutes, is amended, and subsection (10) is added to that |
| 818 | section, to read: |
| 819 | 20.43 Department of Health.-There is created a Department |
| 820 | of Health. |
| 821 | (6) The State Surgeon General is and division directors |
| 822 | are authorized to appoint ad hoc advisory committees as |
| 823 | necessary. The issue or problem that the ad hoc committee shall |
| 824 | address, and the timeframe within which the committee is to |
| 825 | complete its work, shall be specified at the time the committee |
| 826 | is appointed. Ad hoc advisory committees shall include |
| 827 | representatives of groups or entities affected by the issue or |
| 828 | problem that the committee is asked to examine. Members of ad |
| 829 | hoc advisory committees shall receive no compensation, but may, |
| 830 | within existing departmental resources, receive reimbursement |
| 831 | for travel expenses as provided in s. 112.061. |
| 832 | (10)(a) Beginning in fiscal year 2010-2011, the department |
| 833 | shall initiate or commence new programs only when the |
| 834 | Legislative Budget Commission or the Legislature expressly |
| 835 | authorizes the department to do so. |
| 836 | (b) Beginning in fiscal year 2010-2011, before applying |
| 837 | for any continuation of or new federal or private grants that |
| 838 | are for an amount of $50,000 or greater, the department shall |
| 839 | provide written notification to the Governor, the President of |
| 840 | the Senate, and the Speaker of the House of Representatives. The |
| 841 | notification must include detailed information about the purpose |
| 842 | of the grant, the intended use of the funds, and the number of |
| 843 | full-time permanent or temporary employees needed to administer |
| 844 | the program funded by the grant. |
| 845 | Section 16. Subsection (14) of section 381.0011, Florida |
| 846 | Statutes, 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 |
| 849 | is the duty of the Department of Health to: |
| 850 | (14) Manage and coordinate emergency preparedness and |
| 851 | disaster response functions to: investigate and control the |
| 852 | spread of disease; coordinate the availability and staffing of |
| 853 | special needs shelters; support patient evacuation; ensure the |
| 854 | safety of food and drugs; provide critical incident stress |
| 855 | debriefing; and provide surveillance and control of |
| 856 | radiological, chemical, biological, and other environmental |
| 857 | hazards. |
| 858 | Section 17. Subsection (16) of section 381.006, Florida |
| 859 | Statutes, is amended to read: |
| 860 | 381.006 Environmental health.-The department shall conduct |
| 861 | an environmental health program as part of fulfilling the |
| 862 | state's public health mission. The purpose of this program is to |
| 863 | detect and prevent disease caused by natural and manmade factors |
| 864 | in the environment. The environmental health program shall |
| 865 | include, but not be limited to: |
| 866 | (16) A group-care-facilities function. As used in this |
| 867 | subsection, the term, where a "group care facility" means any |
| 868 | public or private school, assisted living facility, adult |
| 869 | family-care home, adult day care center, short-term residential |
| 870 | treatment center, residential treatment facility, home for |
| 871 | special services, transitional living facility, crisis |
| 872 | stabilization unit, hospice, prescribed pediatric extended care |
| 873 | center, intermediate care facility for persons with |
| 874 | developmental disabilities, or boarding school housing, building |
| 875 | or buildings, section of a building, or distinct part of a |
| 876 | building or other place, whether operated for profit or not, |
| 877 | which undertakes, through its ownership or management, to |
| 878 | provide one or more personal services, care, protection, and |
| 879 | supervision to persons who require such services and who are not |
| 880 | related to the owner or administrator. The department may adopt |
| 881 | rules necessary to protect the health and safety of residents, |
| 882 | staff, and patrons of group care facilities. Rules related to |
| 883 | public and private schools shall be developed by, such as child |
| 884 | care facilities, family day care homes, assisted living |
| 885 | facilities, adult day care centers, adult family care homes, |
| 886 | hospices, residential treatment facilities, crisis stabilization |
| 887 | units, pediatric extended care centers, intermediate care |
| 888 | facilities for the developmentally disabled, group care homes, |
| 889 | and, jointly with the Department of Education in consultation |
| 890 | with the department, private and public schools. These Rules |
| 891 | adopted under this subsection may include definitions of terms; |
| 892 | provisions relating to operation and maintenance of facilities, |
| 893 | buildings, grounds, equipment, furnishings, and occupant-space |
| 894 | requirements; lighting; heating, cooling, and ventilation; food |
| 895 | service; water supply and plumbing; sewage; sanitary facilities; |
| 896 | insect and rodent control; garbage; safety; personnel health, |
| 897 | hygiene, and work practices; and other matters the department |
| 898 | finds are appropriate or necessary to protect the safety and |
| 899 | health of the residents, staff, students, faculty, or patrons. |
| 900 | The department may not adopt rules that conflict with rules |
| 901 | adopted by the licensing or certifying agency. The department |
| 902 | may enter and inspect at reasonable hours to determine |
| 903 | compliance with applicable statutes or rules. In addition to any |
| 904 | sanctions that the department may impose for violations of rules |
| 905 | adopted under this section, the department shall also report |
| 906 | such violations to any agency responsible for licensing or |
| 907 | certifying the group care facility. The licensing or certifying |
| 908 | agency may also impose any sanction based solely on the findings |
| 909 | of the department. |
| 910 |
|
| 911 | The department may adopt rules to carry out the provisions of |
| 912 | this section. |
| 913 | Section 18. Subsections (1), (2), (3), and (6) of section |
| 914 | 381.0072, Florida Statutes, are amended to read: |
| 915 | 381.0072 Food service protection.-It shall be the duty of |
| 916 | the Department of Health to adopt and enforce sanitation rules |
| 917 | consistent with law to ensure the protection of the public from |
| 918 | food-borne illness. These rules shall provide the standards and |
| 919 | requirements for the storage, preparation, serving, or display |
| 920 | of food in food service establishments as defined in this |
| 921 | section and which are not permitted or licensed under chapter |
| 922 | 500 or chapter 509. |
| 923 | (1) DEFINITIONS.-As used in this section, the term: |
| 924 | (a) "Department" means the Department of Health or its |
| 925 | representative county health department. |
| 926 | (b) "Food service establishment" means detention |
| 927 | facilities, public or private schools, migrant labor camps, |
| 928 | assisted living facilities, adult family-care homes, adult day |
| 929 | care centers, short-term residential treatment centers, |
| 930 | residential treatment facilities, homes for special services, |
| 931 | transitional living facilities, crisis stabilization units, |
| 932 | hospices, prescribed pediatric extended care centers, |
| 933 | intermediate care facilities for persons with developmental |
| 934 | disabilities, boarding schools, civic or fraternal |
| 935 | organizations, bars and lounges, vending machines that dispense |
| 936 | potentially hazardous foods at facilities expressly named in |
| 937 | this paragraph, and facilities used as temporary food events or |
| 938 | mobile food units at any facility expressly named any facility, |
| 939 | as described in this paragraph, where food is prepared and |
| 940 | intended for individual portion service, including and includes |
| 941 | the site at which individual portions are provided,. The term |
| 942 | includes any such facility regardless of whether consumption is |
| 943 | on or off the premises and regardless of whether there is a |
| 944 | charge for the food. The term includes detention facilities, |
| 945 | child care facilities, schools, institutions, civic or fraternal |
| 946 | organizations, bars and lounges and facilities used at temporary |
| 947 | food events, mobile food units, and vending machines at any |
| 948 | facility regulated under this section. The term does not include |
| 949 | any entity not expressly named in this paragraph private homes |
| 950 | where food is prepared or served for individual family |
| 951 | consumption; nor does the term include churches, synagogues, or |
| 952 | other not-for-profit religious organizations as long as these |
| 953 | organizations serve only their members and guests and do not |
| 954 | advertise food or drink for public consumption, or any facility |
| 955 | or establishment permitted or licensed under chapter 500 or |
| 956 | chapter 509; nor does the term include any theater, if the |
| 957 | primary use is as a theater and if patron service is limited to |
| 958 | food items customarily served to the admittees of theaters; nor |
| 959 | does the term include a research and development test kitchen |
| 960 | limited to the use of employees and which is not open to the |
| 961 | general public. |
| 962 | (c) "Operator" means the owner, operator, keeper, |
| 963 | proprietor, lessee, manager, assistant manager, agent, or |
| 964 | employee of a food service establishment. |
| 965 | (2) DUTIES.- |
| 966 | (a) The department may advise and consult with the Agency |
| 967 | for Health Care Administration, the Department of Business and |
| 968 | Professional Regulation, the Department of Agriculture and |
| 969 | Consumer Services, and the Department of Children and Family |
| 970 | Services concerning procedures related to the storage, |
| 971 | preparation, serving, or display of food at any building, |
| 972 | structure, or facility not expressly included in this section |
| 973 | that is inspected, licensed, or regulated by those agencies. |
| 974 | (b)(a) The department shall adopt rules, including |
| 975 | definitions of terms which are consistent with law prescribing |
| 976 | minimum sanitation standards and manager certification |
| 977 | requirements as prescribed in s. 509.039, and which shall be |
| 978 | enforced in food service establishments as defined in this |
| 979 | section. The sanitation standards must address the construction, |
| 980 | operation, and maintenance of the establishment; lighting, |
| 981 | ventilation, laundry rooms, lockers, use and storage of toxic |
| 982 | materials and cleaning compounds, and first-aid supplies; plan |
| 983 | review; design, construction, installation, location, |
| 984 | maintenance, sanitation, and storage of food equipment and |
| 985 | utensils; employee training, health, hygiene, and work |
| 986 | practices; food supplies, preparation, storage, transportation, |
| 987 | and service, including access to the areas where food is stored |
| 988 | or prepared; and sanitary facilities and controls, including |
| 989 | water supply and sewage disposal; plumbing and toilet |
| 990 | facilities; garbage and refuse collection, storage, and |
| 991 | disposal; and vermin control. Public and private schools, if the |
| 992 | food service is operated by school employees,; hospitals |
| 993 | licensed under chapter 395; nursing homes licensed under part II |
| 994 | of chapter 400; child care facilities as defined in s. 402.301; |
| 995 | residential facilities colocated with a nursing home or |
| 996 | hospital, if all food is prepared in a central kitchen that |
| 997 | complies with nursing or hospital regulations; and bars and |
| 998 | lounges, civic organizations, and any other facility that is not |
| 999 | regulated under this section as defined by department rule, are |
| 1000 | exempt from the rules developed for manager certification. The |
| 1001 | department shall administer a comprehensive inspection, |
| 1002 | monitoring, and sampling program to ensure such standards are |
| 1003 | maintained. With respect to food service establishments |
| 1004 | permitted or licensed under chapter 500 or chapter 509, the |
| 1005 | department shall assist the Division of Hotels and Restaurants |
| 1006 | of the Department of Business and Professional Regulation and |
| 1007 | the Department of Agriculture and Consumer Services with |
| 1008 | rulemaking by providing technical information. |
| 1009 | (c)(b) The department shall carry out all provisions of |
| 1010 | this chapter and all other applicable laws and rules relating to |
| 1011 | the inspection or regulation of food service establishments as |
| 1012 | defined in this section, for the purpose of safeguarding the |
| 1013 | public's health, safety, and welfare. |
| 1014 | (d)(c) The department shall inspect each food service |
| 1015 | establishment as often as necessary to ensure compliance with |
| 1016 | applicable laws and rules. The department shall have the right |
| 1017 | of entry and access to these food service establishments at any |
| 1018 | reasonable time. In inspecting food service establishments as |
| 1019 | provided under this section, the department shall provide each |
| 1020 | inspected establishment with the food recovery brochure |
| 1021 | developed under s. 570.0725. |
| 1022 | (e)(d) The department or other appropriate regulatory |
| 1023 | entity may inspect theaters exempted in subsection (1) to ensure |
| 1024 | compliance with applicable laws and rules pertaining to minimum |
| 1025 | sanitation standards. A fee for inspection shall be prescribed |
| 1026 | by rule, but the aggregate amount charged per year per theater |
| 1027 | establishment shall not exceed $300, regardless of the entity |
| 1028 | providing the inspection. |
| 1029 | (3) LICENSES REQUIRED.- |
| 1030 | (a) Licenses; annual renewals.-Each food service |
| 1031 | establishment regulated under this section shall obtain a |
| 1032 | license from the department annually. Food service establishment |
| 1033 | licenses shall expire annually and are not transferable from one |
| 1034 | place or individual to another. However, those facilities |
| 1035 | licensed by the department's Office of Licensure and |
| 1036 | Certification, the Child Care Services Program Office, or the |
| 1037 | Agency for Persons with Disabilities are exempt from this |
| 1038 | subsection. It shall be a misdemeanor of the second degree, |
| 1039 | punishable as provided in s. 381.0061, s. 775.082, or s. |
| 1040 | 775.083, for such an establishment to operate without this |
| 1041 | license. The department may refuse a license, or a renewal |
| 1042 | thereof, to any establishment that is not constructed or |
| 1043 | maintained in accordance with law and with the rules of the |
| 1044 | department. Annual application for renewal is not required. |
| 1045 | (b) Application for license.-Each person who plans to open |
| 1046 | a food service establishment regulated under this section and |
| 1047 | not regulated under chapter 500 or chapter 509 shall apply for |
| 1048 | and 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 |
| 1051 | those establishments regulated by the department under this |
| 1052 | chapter, the department, to protect the public from food that is |
| 1053 | unwholesome or otherwise unfit for human consumption, may |
| 1054 | examine, sample, seize, and stop the sale or use of food to |
| 1055 | determine its condition. The department may stop the sale and |
| 1056 | supervise the proper destruction of food when the State Health |
| 1057 | Officer or his or her designee determines that such food |
| 1058 | represents a threat to the public health. |
| 1059 | (b) The department may determine that a food service |
| 1060 | establishment regulated under this section is an imminent danger |
| 1061 | to the public health and require its immediate closure when such |
| 1062 | establishment fails to comply with applicable sanitary and |
| 1063 | safety standards and, because of such failure, presents an |
| 1064 | imminent threat to the public's health, safety, and welfare. The |
| 1065 | department may accept inspection results from state and local |
| 1066 | building and firesafety officials and other regulatory agencies |
| 1067 | as justification for such actions. Any facility so deemed and |
| 1068 | closed shall remain closed until allowed by the department or by |
| 1069 | judicial order to reopen. |
| 1070 | Section 19. Sections 411.23, 411.231, and 411.232, Florida |
| 1071 | Statutes, are repealed. |
| 1072 | Section 20. Paragraph (d) of subsection (5) of section |
| 1073 | 411.01, Florida Statutes, is amended to read: |
| 1074 | 411.01 School readiness programs; early learning |
| 1075 | coalitions.- |
| 1076 | (5) CREATION OF EARLY LEARNING COALITIONS.- |
| 1077 | (d) Implementation.- |
| 1078 | 1. An early learning coalition may not implement the |
| 1079 | school readiness program until the coalition is authorized |
| 1080 | through approval of the coalition's school readiness plan by the |
| 1081 | Agency for Workforce Innovation. |
| 1082 | 2. Each early learning coalition shall develop a plan for |
| 1083 | implementing the school readiness program to meet the |
| 1084 | requirements of this section and the performance standards and |
| 1085 | outcome measures adopted by the Agency for Workforce Innovation. |
| 1086 | The plan must demonstrate how the program will ensure that each |
| 1087 | 3-year-old and 4-year-old child in a publicly funded school |
| 1088 | readiness program receives scheduled activities and instruction |
| 1089 | designed to enhance the age-appropriate progress of the children |
| 1090 | in attaining the performance standards adopted by the Agency for |
| 1091 | Workforce Innovation under subparagraph (4)(d)8. Before |
| 1092 | implementing the school readiness program, the early learning |
| 1093 | coalition must submit the plan to the Agency for Workforce |
| 1094 | Innovation for approval. The Agency for Workforce Innovation may |
| 1095 | approve the plan, reject the plan, or approve the plan with |
| 1096 | conditions. The Agency for Workforce Innovation shall review |
| 1097 | school readiness plans at least annually. |
| 1098 | 3. If the Agency for Workforce Innovation determines |
| 1099 | during the annual review of school readiness plans, or through |
| 1100 | monitoring and performance evaluations conducted under paragraph |
| 1101 | (4)(l), that an early learning coalition has not substantially |
| 1102 | implemented its plan, has not substantially met the performance |
| 1103 | standards and outcome measures adopted by the agency, or has not |
| 1104 | effectively administered the school readiness program or |
| 1105 | Voluntary Prekindergarten Education Program, the Agency for |
| 1106 | Workforce Innovation may dissolve the coalition and temporarily |
| 1107 | contract with a qualified entity to continue school readiness |
| 1108 | and prekindergarten services in the coalition's county or |
| 1109 | multicounty region until the coalition is reestablished through |
| 1110 | resubmission of a school readiness plan and approval by the |
| 1111 | agency. |
| 1112 | 4. The Agency for Workforce Innovation shall adopt |
| 1113 | criteria for the approval of school readiness plans. The |
| 1114 | criteria must be consistent with the performance standards and |
| 1115 | outcome measures adopted by the agency and must require each |
| 1116 | approved plan to include the following minimum standards and |
| 1117 | provisions: |
| 1118 | a. A sliding fee scale establishing a copayment for |
| 1119 | parents based upon their ability to pay, which is the same for |
| 1120 | all program providers, to be implemented and reflected in each |
| 1121 | program's budget. |
| 1122 | b. A choice of settings and locations in licensed, |
| 1123 | registered, religious-exempt, or school-based programs to be |
| 1124 | provided to parents. |
| 1125 | c. Instructional staff who have completed the training |
| 1126 | course as required in s. 402.305(2)(d)1., as well as staff who |
| 1127 | have additional training or credentials as required by the |
| 1128 | Agency for Workforce Innovation. The plan must provide a method |
| 1129 | for assuring the qualifications of all personnel in all program |
| 1130 | settings. |
| 1131 | d. Specific eligibility priorities for children within the |
| 1132 | early learning coalition's county or multicounty region in |
| 1133 | accordance with subsection (6). |
| 1134 | e. Performance standards and outcome measures adopted by |
| 1135 | the Agency for Workforce Innovation. |
| 1136 | f. Payment rates adopted by the early learning coalition |
| 1137 | and approved by the Agency for Workforce Innovation. Payment |
| 1138 | rates may not have the effect of limiting parental choice or |
| 1139 | creating standards or levels of services that have not been |
| 1140 | authorized by the Legislature. |
| 1141 | g. Systems support services, including a central agency, |
| 1142 | child care resource and referral, eligibility determinations, |
| 1143 | training of providers, and parent support and involvement. |
| 1144 | h. Direct enhancement services to families and children. |
| 1145 | System support and direct enhancement services shall be in |
| 1146 | addition to payments for the placement of children in school |
| 1147 | readiness programs. |
| 1148 | i. The business organization of the early learning |
| 1149 | coalition, which must include the coalition's articles of |
| 1150 | incorporation and bylaws if the coalition is organized as a |
| 1151 | corporation. If the coalition is not organized as a corporation |
| 1152 | or other business entity, the plan must include the contract |
| 1153 | with a fiscal agent. An early learning coalition may contract |
| 1154 | with other coalitions to achieve efficiency in multicounty |
| 1155 | services, and these contracts may be part of the coalition's |
| 1156 | school readiness plan. |
| 1157 | j. Strategies to meet the needs of unique populations, |
| 1158 | such as migrant workers. |
| 1159 |
|
| 1160 | As part of the school readiness plan, the early learning |
| 1161 | coalition may request the Governor to apply for a waiver to |
| 1162 | allow the coalition to administer the Head Start Program to |
| 1163 | accomplish the purposes of the school readiness program. If a |
| 1164 | school readiness plan demonstrates that specific statutory goals |
| 1165 | can be achieved more effectively by using procedures that |
| 1166 | require modification of existing rules, policies, or procedures, |
| 1167 | a request for a waiver to the Agency for Workforce Innovation |
| 1168 | may be submitted as part of the plan. Upon review, the Agency |
| 1169 | for Workforce Innovation may grant the proposed modification. |
| 1170 | 5. Persons with an early childhood teaching certificate |
| 1171 | may provide support and supervision to other staff in the school |
| 1172 | readiness program. |
| 1173 | 6. An early learning coalition may not implement its |
| 1174 | school readiness plan until it submits the plan to and receives |
| 1175 | approval from the Agency for Workforce Innovation. Once the plan |
| 1176 | is approved, the plan and the services provided under the plan |
| 1177 | shall be controlled by the early learning coalition. The plan |
| 1178 | shall be reviewed and revised as necessary, but at least |
| 1179 | biennially. An early learning coalition may not implement the |
| 1180 | revisions until the coalition submits the revised plan to and |
| 1181 | receives approval from the Agency for Workforce Innovation. If |
| 1182 | the Agency for Workforce Innovation rejects a revised plan, the |
| 1183 | coalition must continue to operate under its prior approved |
| 1184 | plan. |
| 1185 | 7. Sections 125.901(2)(a)3. and, 411.221, and 411.232 do |
| 1186 | not apply to an early learning coalition with an approved school |
| 1187 | readiness plan. To facilitate innovative practices and to allow |
| 1188 | the regional establishment of school readiness programs, an |
| 1189 | early learning coalition may apply to the Governor and Cabinet |
| 1190 | for a waiver of, and the Governor and Cabinet may waive, any of |
| 1191 | the provisions of ss. 411.223, 411.232, and 1003.54, if the |
| 1192 | waiver is necessary for implementation of the coalition's school |
| 1193 | readiness plan. |
| 1194 | 8. Two or more counties may join for purposes of planning |
| 1195 | and implementing a school readiness program. |
| 1196 | 9. An early learning coalition may, subject to approval by |
| 1197 | the Agency for Workforce Innovation as part of the coalition's |
| 1198 | school readiness plan, receive subsidized child care funds for |
| 1199 | all children eligible for any federal subsidized child care |
| 1200 | program. |
| 1201 | 10. An early learning coalition may enter into multiparty |
| 1202 | contracts with multicounty service providers in order to meet |
| 1203 | the needs of unique populations such as migrant workers. |
| 1204 | Section 21. Subsection (2) of section 411.224, Florida |
| 1205 | Statutes, is amended to read: |
| 1206 | 411.224 Family support planning process.-The Legislature |
| 1207 | establishes a family support planning process to be used by the |
| 1208 | Department of Children and Family Services as the service |
| 1209 | planning process for targeted individuals, children, and |
| 1210 | families under its purview. |
| 1211 | (2) To the extent possible within existing resources, the |
| 1212 | following populations must be included in the family support |
| 1213 | planning process: |
| 1214 | (a) Children from birth to age 5 who are served by the |
| 1215 | clinic and programs of the Division of Children's Medical |
| 1216 | Services of the Department of Health. |
| 1217 | (b) Children participating in the developmental evaluation |
| 1218 | and intervention program of the Division of Children's Medical |
| 1219 | Services of the Department of Health. |
| 1220 | (c) Children from age 3 through age 5 who are served by |
| 1221 | the Agency for Persons with Disabilities. |
| 1222 | (d) Children from birth through age 5 who are served by |
| 1223 | the Mental Health Program Office of the Department of Children |
| 1224 | and Family Services. |
| 1225 | (e) Participants who are served by the Children's Early |
| 1226 | Investment Program established in s. 411.232. |
| 1227 | (e)(f) Healthy Start participants in need of ongoing |
| 1228 | service coordination. |
| 1229 | (f)(g) Children from birth through age 5 who are served by |
| 1230 | the voluntary family services, protective supervision, foster |
| 1231 | care, or adoption and related services programs of the Child |
| 1232 | Care Services Program Office of the Department of Children and |
| 1233 | Family Services, and who are eligible for ongoing services from |
| 1234 | one or more other programs or agencies that participate in |
| 1235 | family support planning; however, children served by the |
| 1236 | voluntary family services program, where the planned length of |
| 1237 | intervention is 30 days or less, are excluded from this |
| 1238 | population. |
| 1239 | Section 22. Subsections (32) through (54) of section |
| 1240 | 499.003, Florida Statutes, are renumbered as subsections (33) |
| 1241 | through (55), respectively, present subsection (42) is amended, |
| 1242 | and a new subsection (32) is added to that section, to read: |
| 1243 | 499.003 Definitions of terms used in this part.-As used in |
| 1244 | this part, the term: |
| 1245 | (32) "Medical convenience kit" means packages or units |
| 1246 | that contain combination products as defined in 21 C.F.R. s. |
| 1247 | 3.2(e)(2). |
| 1248 | (43)(42) "Prescription drug" means a prescription, |
| 1249 | medicinal, or legend drug, including, but not limited to, |
| 1250 | finished dosage forms or active ingredients subject to, defined |
| 1251 | by, or described by s. 503(b) of the Federal Food, Drug, and |
| 1252 | Cosmetic 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 |
| 1255 | 499.01, 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 |
| 1260 | that engages in the manufacture, repackaging, or assembly of |
| 1261 | medical devices for human use in this state, except that a |
| 1262 | permit is not required if: |
| 1263 | a. The person is engaged only in manufacturing, |
| 1264 | repackaging, or assembling a medical device pursuant to a |
| 1265 | practitioner's order for a specific patient; or |
| 1266 | b. The person does not manufacture, repackage, or assemble |
| 1267 | any medical devices or components for such devices, except those |
| 1268 | devices or components which are exempt from registration |
| 1269 | pursuant to s. 499.015(8). |
| 1270 | 2.1. A manufacturer or repackager of medical devices in |
| 1271 | this state must comply with all appropriate state and federal |
| 1272 | good manufacturing practices and quality system rules. |
| 1273 | 3.2. The department shall adopt rules related to storage, |
| 1274 | handling, and recordkeeping requirements for manufacturers of |
| 1275 | medical devices for human use. |
| 1276 | Section 24. Paragraph (i) is added to subsection (3) of |
| 1277 | section 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 |
| 1281 | within a medical convenience kit if: |
| 1282 | 1. The medical convenience kit is assembled in an |
| 1283 | establishment that is registered with the United States Food and |
| 1284 | Drug Administration as a medical device manufacturer; |
| 1285 | 2. The medical convenience kit manufacturer purchased the |
| 1286 | prescription drug directly from the manufacturer or from a |
| 1287 | wholesaler that purchased the prescription drug directly from |
| 1288 | the manufacturer; |
| 1289 | 3. The medical convenience kit manufacturer complies with |
| 1290 | federal law for the distribution of the prescription drugs |
| 1291 | within the kit; and |
| 1292 | 4. The drugs contained in the medical kit are: |
| 1293 | a. Intravenous solutions intended for the replenishment of |
| 1294 | fluids and electrolytes; |
| 1295 | b. Products intended to maintain the equilibrium of water |
| 1296 | and minerals in the body; |
| 1297 | c. Products intended for irrigation or reconstitution; |
| 1298 | d. Anesthetics; or |
| 1299 | e. Anticoagulants. |
| 1300 |
|
| 1301 | This exemption does not apply to a convenience kit containing |
| 1302 | any controlled substance that appears in a schedule contained in |
| 1303 | or subject to chapter 893 or the federal Comprehensive Drug |
| 1304 | Abuse Prevention and Control Act of 1970. |
| 1305 | Section 25. Subsections (4) and (5) of section 509.013, |
| 1306 | Florida 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 |
| 1309 | public lodging establishment as defined in subparagraph 1. and a |
| 1310 | nontransient public lodging establishment as defined in |
| 1311 | subparagraph 2. |
| 1312 | 1. "Transient public lodging establishment" means any |
| 1313 | unit, group of units, dwelling, building, or group of buildings |
| 1314 | within a single complex of buildings which is rented to guests |
| 1315 | more than three times in a calendar year for periods of less |
| 1316 | than 30 days or 1 calendar month, whichever is less, or which is |
| 1317 | advertised or held out to the public as a place regularly rented |
| 1318 | to guests. |
| 1319 | 2. "Nontransient public lodging establishment" means any |
| 1320 | unit, group of units, dwelling, building, or group of buildings |
| 1321 | within a single complex of buildings which is rented to guests |
| 1322 | for periods of at least 30 days or 1 calendar month, whichever |
| 1323 | is less, or which is advertised or held out to the public as a |
| 1324 | place regularly rented to guests for periods of at least 30 days |
| 1325 | or 1 calendar month. |
| 1326 |
|
| 1327 | License classifications of public lodging establishments, and |
| 1328 | the definitions therefor, are set out in s. 509.242. For the |
| 1329 | purpose of licensure, the term does not include condominium |
| 1330 | common elements as defined in s. 718.103. |
| 1331 | (b) The following are excluded from the definitions in |
| 1332 | paragraph (a): |
| 1333 | 1. Any dormitory or other living or sleeping facility |
| 1334 | maintained by a public or private school, college, or university |
| 1335 | for the use of students, faculty, or visitors; |
| 1336 | 2. Any facility certified or licensed and regulated by the |
| 1337 | Agency for Health Care Administration or the Department of |
| 1338 | Children and Family Services hospital, nursing home, sanitarium, |
| 1339 | assisted living facility, or other similar place regulated under |
| 1340 | s. 381.0072; |
| 1341 | 3. Any place renting four rental units or less, unless the |
| 1342 | rental units are advertised or held out to the public to be |
| 1343 | places that are regularly rented to transients; |
| 1344 | 4. Any unit or group of units in a condominium, |
| 1345 | cooperative, or timeshare plan and any individually or |
| 1346 | collectively owned one-family, two-family, three-family, or |
| 1347 | four-family dwelling house or dwelling unit that is rented for |
| 1348 | periods of at least 30 days or 1 calendar month, whichever is |
| 1349 | less, and that is not advertised or held out to the public as a |
| 1350 | place regularly rented for periods of less than 1 calendar |
| 1351 | month, provided that no more than four rental units within a |
| 1352 | single complex of buildings are available for rent; |
| 1353 | 5. Any migrant labor camp or residential migrant housing |
| 1354 | permitted by the Department of Health; under ss. 381.008- |
| 1355 | 381.00895; and |
| 1356 | 6. Any establishment inspected by the Department of Health |
| 1357 | and regulated by chapter 513. |
| 1358 | (5)(a) "Public food service establishment" means any |
| 1359 | building, vehicle, place, or structure, or any room or division |
| 1360 | in a building, vehicle, place, or structure where food is |
| 1361 | prepared, served, or sold for immediate consumption on or in the |
| 1362 | vicinity of the premises; called for or taken out by customers; |
| 1363 | or prepared prior to being delivered to another location for |
| 1364 | consumption. |
| 1365 | (b) The following are excluded from the definition in |
| 1366 | paragraph (a): |
| 1367 | 1. Any place maintained and operated by a public or |
| 1368 | private school, college, or university: |
| 1369 | a. For the use of students and faculty; or |
| 1370 | b. Temporarily to serve such events as fairs, carnivals, |
| 1371 | and athletic contests. |
| 1372 | 2. Any eating place maintained and operated by a church or |
| 1373 | a religious, nonprofit fraternal, or nonprofit civic |
| 1374 | organization: |
| 1375 | a. For the use of members and associates; or |
| 1376 | b. Temporarily to serve such events as fairs, carnivals, |
| 1377 | or athletic contests. |
| 1378 | 3. Any eating place located on an airplane, train, bus, or |
| 1379 | watercraft which is a common carrier. |
| 1380 | 4. Any eating place maintained by a facility certified or |
| 1381 | licensed and regulated by the Agency for Health Care |
| 1382 | Administration or the Department of Children and Family Services |
| 1383 | hospital, nursing home, sanitarium, assisted living facility, |
| 1384 | adult day care center, or other similar place that is regulated |
| 1385 | under s. 381.0072. |
| 1386 | 5. Any place of business issued a permit or inspected by |
| 1387 | the Department of Agriculture and Consumer Services under s. |
| 1388 | 500.12. |
| 1389 | 6. Any place of business where the food available for |
| 1390 | consumption is limited to ice, beverages with or without |
| 1391 | garnishment, popcorn, or prepackaged items sold without |
| 1392 | additions or preparation. |
| 1393 | 7. Any theater, if the primary use is as a theater and if |
| 1394 | patron service is limited to food items customarily served to |
| 1395 | the admittees of theaters. |
| 1396 | 8. Any vending machine that dispenses any food or |
| 1397 | beverages other than potentially hazardous foods, as defined by |
| 1398 | division rule. |
| 1399 | 9. Any vending machine that dispenses potentially |
| 1400 | hazardous food and which is located in a facility regulated |
| 1401 | under s. 381.0072. |
| 1402 | 10. Any research and development test kitchen limited to |
| 1403 | the use of employees and which is not open to the general |
| 1404 | public. |
| 1405 | Section 26. The Department of Health shall develop a plan |
| 1406 | that exclusively uses private and nonstate public hospitals to |
| 1407 | provide treatment to cure, hospitalization, and isolation for |
| 1408 | persons with contagious cases of tuberculosis who pose a threat |
| 1409 | to the public. The department shall submit the plan to the |
| 1410 | Governor, the President of the Senate, and the Speaker of the |
| 1411 | House of Representatives by November 1, 2010. The plan shall |
| 1412 | include the following elements: |
| 1413 | (1) Identification of hospitals functionally capable of |
| 1414 | caring for such patients. |
| 1415 | (2) Reimbursement for hospital inpatient services at the |
| 1416 | Medicaid rate and reimbursement for other medically necessary |
| 1417 | services that are not hospital inpatient services at the |
| 1418 | relevant Medicaid rate. |
| 1419 | (3) Projected cost estimates. |
| 1420 | (4) A transition plan for closing the A. G. Holley State |
| 1421 | Hospital and transferring patients to private and nonstate |
| 1422 | public hospitals over a 90-day period of time. |
| 1423 | Section 27. (1) All of the statutory powers, duties, and |
| 1424 | functions, records, personnel, property, and unexpended balances |
| 1425 | of appropriations, allocations, or other funds for the |
| 1426 | administration of chapter 499, Florida Statutes, relating to |
| 1427 | drugs, devices, cosmetics, and household products shall be |
| 1428 | transferred by a type two transfer, as defined in s. 20.06(2), |
| 1429 | Florida Statutes, from the Department of Health to the |
| 1430 | Department of Business and Professional Regulation. |
| 1431 | (2) The transfer of regulatory authority under chapter |
| 1432 | 499, Florida Statutes, provided by this section shall not affect |
| 1433 | the validity of any judicial or administrative action pending as |
| 1434 | of 11:59 p.m. on the day before the effective date of this |
| 1435 | section to which the Department of Health is at that time a |
| 1436 | party, and the Department of Business and Professional |
| 1437 | Regulation shall be substituted as a party in interest in any |
| 1438 | such action. |
| 1439 | (3) All lawful orders issued by the Department of Health |
| 1440 | implementing or enforcing or otherwise in regard to any |
| 1441 | provision of chapter 499, Florida Statutes, issued prior to the |
| 1442 | effective date of this section shall remain in effect and be |
| 1443 | enforceable after the effective date of this section unless |
| 1444 | thereafter modified in accordance with law. |
| 1445 | (4) The rules of the Department of Health relating to the |
| 1446 | implementation of chapter 499, Florida Statutes, that were in |
| 1447 | effect at 11:59 p.m. on the day prior to the effective date of |
| 1448 | this section shall become the rules of the Department of |
| 1449 | Business and Professional Regulation and shall remain in effect |
| 1450 | until amended or repealed in the manner provided by law. |
| 1451 | (5) Notwithstanding the transfer of regulatory authority |
| 1452 | under chapter 499, Florida Statutes, provided by this section, |
| 1453 | persons and entities holding in good standing any permit under |
| 1454 | chapter 499, Florida Statutes, as of 11:59 p.m. on the day prior |
| 1455 | to the effective date of this section shall, as of the effective |
| 1456 | date of this section, be deemed to hold in good standing a |
| 1457 | permit in the same capacity as that for which the permit was |
| 1458 | formerly issued. |
| 1459 | (6) Notwithstanding the transfer of regulatory authority |
| 1460 | under chapter 499, Florida Statutes, provided by this section, |
| 1461 | persons holding in good standing any certification under chapter |
| 1462 | 499, Florida Statutes, as of 11:59 p.m. on the day prior to the |
| 1463 | effective date of this section shall, as of the effective date |
| 1464 | of this section, be deemed to be certified in the same capacity |
| 1465 | in which they were formerly certified. |
| 1466 | (7) This section shall take effect October 1, 2011. |
| 1467 | Section 28. Paragraph (a) of subsection (3) and |
| 1468 | subsections (9) and (10) of section 381.0403, Florida Statutes, |
| 1469 | are amended to read: |
| 1470 | 381.0403 The Community Hospital Education Act.- |
| 1471 | (3) PROGRAM FOR COMMUNITY HOSPITAL EDUCATION; STATE AND |
| 1472 | LOCAL PLANNING.- |
| 1473 | (a) There is established under the Department of Health a |
| 1474 | program for statewide graduate medical education. It is intended |
| 1475 | that continuing graduate medical education programs for interns |
| 1476 | and residents be established on a statewide basis. The program |
| 1477 | shall provide financial support for primary care specialty |
| 1478 | interns and residents based on policies recommended and approved |
| 1479 | by the Community Hospital Education Council, herein established, |
| 1480 | and the Department of Health. Only those programs with at least |
| 1481 | three residents or interns in each year of the training program |
| 1482 | are qualified to apply for financial support. Programs with |
| 1483 | fewer than three residents or interns per training year are |
| 1484 | qualified to apply for financial support, but only if the |
| 1485 | appropriate accrediting entity for the particular specialty has |
| 1486 | approved the program for fewer positions. Programs added after |
| 1487 | fiscal year 1997-1998 shall have 5 years to attain the requisite |
| 1488 | number of residents or interns. When feasible and to the extent |
| 1489 | allowed through the General Appropriations Act, state funds |
| 1490 | shall be used to generate federal matching funds under Medicaid, |
| 1491 | or other federal programs, and the resulting combined state and |
| 1492 | federal funds shall be allocated to participating hospitals for |
| 1493 | the support of graduate medical education. The department may |
| 1494 | spend up to $75,000 of the state appropriation for |
| 1495 | administrative costs associated with the production of the |
| 1496 | annual report as specified in subsection (9), and for |
| 1497 | administration of the program. |
| 1498 | (9) ANNUAL REPORT ON GRADUATE MEDICAL EDUCATION; |
| 1499 | COMMITTEE.-The Executive Office of the Governor, the Department |
| 1500 | of Health, and the Agency for Health Care Administration shall |
| 1501 | collaborate to establish a committee that shall produce an |
| 1502 | annual report on graduate medical education. The committee shall |
| 1503 | be comprised of 11 members: five members shall be deans of the |
| 1504 | medical schools or their designees; the Governor shall appoint |
| 1505 | two members, one of whom must be a representative of the Florida |
| 1506 | Medical Association who has supervised or currently supervises |
| 1507 | residents or interns and one of whom must be a representative of |
| 1508 | the Florida Hospital Association; the Secretary of Health Care |
| 1509 | Administration shall appoint two members, one of whom must be a |
| 1510 | representative of a statutory teaching hospital and one of whom |
| 1511 | must be a physician who has supervised or is currently |
| 1512 | supervising residents or interns; and the State Surgeon General |
| 1513 | shall appoint two members, one of whom must be a representative |
| 1514 | of a statutory family practice teaching hospital and one of whom |
| 1515 | must be a physician who has supervised or is currently |
| 1516 | supervising residents or interns. With the exception of the |
| 1517 | deans, members shall serve 4-year terms. In order to stagger the |
| 1518 | terms, the Governor's appointees shall serve initial terms of 4 |
| 1519 | years, the State Surgeon General's appointees shall serve |
| 1520 | initial terms of 3 years, and the Secretary of Health Care |
| 1521 | Administration's appointees shall serve initial terms of 2 |
| 1522 | years. A member's term shall be deemed terminated when the |
| 1523 | member's representative status no longer exists. Once the |
| 1524 | committee is appointed, it shall elect a chair to serve for a 1- |
| 1525 | year term. The report shall be provided to the Governor, the |
| 1526 | President of the Senate, and the Speaker of the House of |
| 1527 | Representatives by January 15 annually. Committee members shall |
| 1528 | serve without compensation. The report shall address the |
| 1529 | following: |
| 1530 | (a) The role of residents and medical faculty in the |
| 1531 | provision of health care. |
| 1532 | (b) The relationship of graduate medical education to the |
| 1533 | state's physician workforce. |
| 1534 | (c) The costs of training medical residents for hospitals, |
| 1535 | medical schools, teaching hospitals, including all hospital- |
| 1536 | medical affiliations, practice plans at all of the medical |
| 1537 | schools, and municipalities. |
| 1538 | (d) The availability and adequacy of all sources of |
| 1539 | revenue to support graduate medical education and recommend |
| 1540 | alternative sources of funding for graduate medical education. |
| 1541 | (e) The use of state and federal appropriated funds for |
| 1542 | graduate medical education by hospitals receiving such funds. |
| 1543 | (9)(10) RULEMAKING.-The department has authority to adopt |
| 1544 | rules pursuant to ss. 120.536(1) and 120.54 to implement the |
| 1545 | provisions of this section. |
| 1546 | Section 29. Section 381.4018, Florida Statutes, is amended |
| 1547 | to 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 |
| 1551 | statutory teaching hospitals, specialty children's hospitals, |
| 1552 | statutory rural hospitals, other hospitals, accredited medical |
| 1553 | schools, clinics operated by the Department of Health, clinics |
| 1554 | operated by the Department of Veterans' Affairs, area health |
| 1555 | education centers, community health centers, federally qualified |
| 1556 | health centers, prison clinics, local community clinics, or |
| 1557 | other programs. At least one member of the consortium shall be a |
| 1558 | sponsoring institution accredited or currently seeking |
| 1559 | accreditation by the Accreditation Council for Graduate Medical |
| 1560 | Education or the American Osteopathic Association. |
| 1561 | (b) "Council" means the Physician Workforce Advisory |
| 1562 | Council. |
| 1563 | (c) "Department" means the Department of Health. |
| 1564 | (d) "Graduate medical education program" means a program |
| 1565 | accredited by the Accreditation Council for Graduate Medical |
| 1566 | Education or the American Osteopathic Association. |
| 1567 | (e) "Primary care specialty" means emergency medicine, |
| 1568 | family practice, internal medicine, pediatrics, psychiatry, |
| 1569 | geriatrics, general surgery, obstetrics and gynecology, and |
| 1570 | combined pediatrics and internal medicine and other specialties |
| 1571 | as determined by the Physician Workforce Advisory Council or the |
| 1572 | Department of Health. |
| 1573 | (2)(1) LEGISLATIVE INTENT.-The Legislature recognizes that |
| 1574 | physician workforce planning is an essential component of |
| 1575 | ensuring that there is an adequate and appropriate supply of |
| 1576 | well-trained physicians to meet this state's future health care |
| 1577 | service needs as the general population and elderly population |
| 1578 | of the state increase. The Legislature finds that items to |
| 1579 | consider relative to assessing the physician workforce may |
| 1580 | include physician practice status; specialty mix; geographic |
| 1581 | distribution; demographic information, including, but not |
| 1582 | limited to, age, gender, race, and cultural considerations; and |
| 1583 | needs of current or projected medically underserved areas in the |
| 1584 | state. Long-term strategic planning is essential as the period |
| 1585 | from the time a medical student enters medical school to |
| 1586 | completion of graduate medical education may range from 7 to 10 |
| 1587 | years or longer. The Legislature recognizes that strategies to |
| 1588 | provide for a well-trained supply of physicians must include |
| 1589 | ensuring the availability and capacity of quality graduate |
| 1590 | medical schools and graduate medical education programs in this |
| 1591 | state, as well as using new or existing state and federal |
| 1592 | programs providing incentives for physicians to practice in |
| 1593 | needed specialties and in underserved areas in a manner that |
| 1594 | addresses projected needs for physician manpower. |
| 1595 | (3)(2) PURPOSE.-The department of Health shall serve as a |
| 1596 | coordinating and strategic planning body to actively assess the |
| 1597 | state's current and future physician workforce needs and work |
| 1598 | with multiple stakeholders to develop strategies and |
| 1599 | alternatives to address current and projected physician |
| 1600 | workforce needs. |
| 1601 | (4)(3) GENERAL FUNCTIONS.-The department shall maximize |
| 1602 | the use of existing programs under the jurisdiction of the |
| 1603 | department and other state agencies and coordinate governmental |
| 1604 | and nongovernmental stakeholders and resources in order to |
| 1605 | develop a state strategic plan and assess the implementation of |
| 1606 | such strategic plan. In developing the state strategic plan, the |
| 1607 | department shall: |
| 1608 | (a) Monitor, evaluate, and report on the supply and |
| 1609 | distribution of physicians licensed under chapter 458 or chapter |
| 1610 | 459. The department shall maintain a database to serve as a |
| 1611 | statewide source of data concerning the physician workforce. |
| 1612 | (b) Develop a model and quantify, on an ongoing basis, the |
| 1613 | adequacy of the state's current and future physician workforce |
| 1614 | as reliable data becomes available. Such model must take into |
| 1615 | account demographics, physician practice status, place of |
| 1616 | education and training, generational changes, population growth, |
| 1617 | economic indicators, and issues concerning the "pipeline" into |
| 1618 | medical education. |
| 1619 | (c) Develop and recommend strategies to determine whether |
| 1620 | the number of qualified medical school applicants who might |
| 1621 | become competent, practicing physicians in this state will be |
| 1622 | sufficient to meet the capacity of the state's medical schools. |
| 1623 | If appropriate, the department shall, working with |
| 1624 | representatives of appropriate governmental and nongovernmental |
| 1625 | entities, develop strategies and recommendations and identify |
| 1626 | best practice programs that introduce health care as a |
| 1627 | profession and strengthen skills needed for medical school |
| 1628 | admission for elementary, middle, and high school students, and |
| 1629 | improve premedical education at the precollege and college level |
| 1630 | in order to increase this state's potential pool of medical |
| 1631 | students. |
| 1632 | (d) Develop strategies to ensure that the number of |
| 1633 | graduates from the state's public and private allopathic and |
| 1634 | osteopathic medical schools is are adequate to meet physician |
| 1635 | workforce needs, based on the analysis of the physician |
| 1636 | workforce data, so as to provide a high-quality medical |
| 1637 | education to students in a manner that recognizes the uniqueness |
| 1638 | of each new and existing medical school in this state. |
| 1639 | (e) Pursue strategies and policies to create, expand, and |
| 1640 | maintain graduate medical education positions in the state based |
| 1641 | on the analysis of the physician workforce data. Such strategies |
| 1642 | and policies must take into account the effect of federal |
| 1643 | funding limitations on the expansion and creation of positions |
| 1644 | in graduate medical education. The department shall develop |
| 1645 | options to address such federal funding limitations. The |
| 1646 | department shall consider options to provide direct state |
| 1647 | funding for graduate medical education positions in a manner |
| 1648 | that addresses requirements and needs relative to accreditation |
| 1649 | of graduate medical education programs. The department shall |
| 1650 | consider funding residency positions as a means of addressing |
| 1651 | needed physician specialty areas, rural areas having a shortage |
| 1652 | of physicians, and areas of ongoing critical need, and as a |
| 1653 | means of addressing the state's physician workforce needs based |
| 1654 | on an ongoing analysis of physician workforce data. |
| 1655 | (f) Develop strategies to maximize federal and state |
| 1656 | programs that provide for the use of incentives to attract |
| 1657 | physicians to this state or retain physicians within the state. |
| 1658 | Such strategies should explore and maximize federal-state |
| 1659 | partnerships that provide incentives for physicians to practice |
| 1660 | in federally designated shortage areas. Strategies shall also |
| 1661 | consider the use of state programs, such as the Florida Health |
| 1662 | Service Corps established pursuant to s. 381.0302 and the |
| 1663 | Medical Education Reimbursement and Loan Repayment Program |
| 1664 | pursuant to s. 1009.65, which provide for education loan |
| 1665 | repayment or loan forgiveness and provide monetary incentives |
| 1666 | for physicians to relocate to underserved areas of the state. |
| 1667 | (g) Coordinate and enhance activities relative to |
| 1668 | physician workforce needs, undergraduate medical education, and |
| 1669 | graduate medical education, and reentry of retired military and |
| 1670 | other physicians into the physician workforce provided by the |
| 1671 | Division of Medical Quality Assurance, the Community Hospital |
| 1672 | Education Program and the Graduate Medical Education Committee |
| 1673 | established pursuant to s. 381.0403, area health education |
| 1674 | center networks established pursuant to s. 381.0402, and other |
| 1675 | offices and programs within the department of Health as |
| 1676 | designated by the State Surgeon General. |
| 1677 | (h) Work in conjunction with and act as a coordinating |
| 1678 | body for governmental and nongovernmental stakeholders to |
| 1679 | address matters relating to the state's physician workforce |
| 1680 | assessment and development for the purpose of ensuring an |
| 1681 | adequate supply of well-trained physicians to meet the state's |
| 1682 | future needs. Such governmental stakeholders shall include, but |
| 1683 | need not be limited to, the State Surgeon General or his or her |
| 1684 | designee, the Commissioner of Education or his or her designee, |
| 1685 | the Secretary of Health Care Administration or his or her |
| 1686 | designee, and the Chancellor of the State University System or |
| 1687 | his or her designee from the Board of Governors of the State |
| 1688 | University System, and, at the discretion of the department, |
| 1689 | other representatives of state and local agencies that are |
| 1690 | involved in assessing, educating, or training the state's |
| 1691 | current or future physicians. Other stakeholders shall include, |
| 1692 | but need not be limited to, organizations representing the |
| 1693 | state's public and private allopathic and osteopathic medical |
| 1694 | schools; organizations representing hospitals and other |
| 1695 | institutions providing health care, particularly those that |
| 1696 | currently provide or have an interest in providing accredited |
| 1697 | medical education and graduate medical education to medical |
| 1698 | students and medical residents; organizations representing |
| 1699 | allopathic and osteopathic practicing physicians; and, at the |
| 1700 | discretion of the department, representatives of other |
| 1701 | organizations or entities involved in assessing, educating, or |
| 1702 | training the state's current or future physicians. |
| 1703 | (i) Serve as a liaison with other states and federal |
| 1704 | agencies and programs in order to enhance resources available to |
| 1705 | the state's physician workforce and medical education continuum. |
| 1706 | (j) Act as a clearinghouse for collecting and |
| 1707 | disseminating information concerning the physician workforce and |
| 1708 | medical education continuum in this state. |
| 1709 | (5) PHYSICIAN WORKFORCE ADVISORY COUNCIL.-There is created |
| 1710 | in the department the Physician Workforce Advisory Council, an |
| 1711 | advisory council as defined in s. 20.03. The council shall |
| 1712 | comply with the requirements of s. 20.052, except as otherwise |
| 1713 | provided in this section. |
| 1714 | (a) The council shall consist of 19 members. Members |
| 1715 | appointed by the State Surgeon General shall include: |
| 1716 | 1. A designee from the department who is a physician |
| 1717 | licensed under chapter 458 or chapter 459 and recommended by the |
| 1718 | State Surgeon General. |
| 1719 | 2. An individual who is affiliated with the Science |
| 1720 | Students Together Reaching Instructional Diversity and |
| 1721 | Excellence program and recommended by the area health education |
| 1722 | center network. |
| 1723 | 3. Two individuals recommended by the Council of Florida |
| 1724 | Medical School Deans, one representing a college of allopathic |
| 1725 | medicine and one representing a college of osteopathic medicine. |
| 1726 | 4. One individual recommended by the Florida Hospital |
| 1727 | Association, representing a hospital that is licensed under |
| 1728 | chapter 395, has an accredited graduate medical education |
| 1729 | program, and is not a statutory teaching hospital. |
| 1730 | 5. One individual representing a statutory teaching |
| 1731 | hospital as defined in s. 408.07 and recommended by the Safety |
| 1732 | Net Hospital Alliance. |
| 1733 | 6. One individual representing a family practice teaching |
| 1734 | hospital as defined in s. 395.805 and recommended by the Council |
| 1735 | of Family Medicine and Community Teaching Hospitals. |
| 1736 | 7. Two individuals recommended by the Florida Medical |
| 1737 | Association, one representing a primary care specialty and one |
| 1738 | representing a nonprimary care specialty. |
| 1739 | 8. Two individuals recommended by the Florida Osteopathic |
| 1740 | Medical Association, one representing a primary care specialty |
| 1741 | and one representing a nonprimary care specialty. |
| 1742 | 9. Two individuals who are program directors of accredited |
| 1743 | graduate medical education programs, one representing a program |
| 1744 | that is accredited by the Accreditation Council for Graduate |
| 1745 | Medical Education and one representing a program that is |
| 1746 | accredited by the American Osteopathic Association. |
| 1747 | 10. An individual recommended by the Florida Association |
| 1748 | of Community Health Centers representing a federally qualified |
| 1749 | health center located in a rural area as defined in s. |
| 1750 | 381.0406(2)(a). |
| 1751 | 11. An individual recommended by the Florida Academy of |
| 1752 | Family Physicians. |
| 1753 | 12. An individual recommended by the Florida Alliance for |
| 1754 | Health Professions Diversity. |
| 1755 | 13. The Chancellor of the State University System or his |
| 1756 | or her designee. |
| 1757 | 14. A layperson member as determined by the State Surgeon |
| 1758 | General. |
| 1759 |
|
| 1760 | Appointments to the council shall be made by the State Surgeon |
| 1761 | General. Each entity authorized to make recommendations under |
| 1762 | this subsection shall make at least two recommendations to the |
| 1763 | State Surgeon General for each appointment to the council. The |
| 1764 | State Surgeon General shall name one appointee for each position |
| 1765 | from the recommendations made by each authorized entity. |
| 1766 | (b) Each council member shall be appointed to a 4-year |
| 1767 | term. An individual may not serve more than two terms. Any |
| 1768 | council member may be removed from office for malfeasance; |
| 1769 | misfeasance; neglect of duty; incompetence; permanent inability |
| 1770 | to perform official duties; or pleading guilty or nolo |
| 1771 | contendere to, or being found guilty of, a felony. Any council |
| 1772 | member who meets the criteria for removal, or who is otherwise |
| 1773 | unwilling or unable to properly fulfill the duties of the |
| 1774 | office, shall be succeeded by an individual chosen by the State |
| 1775 | Surgeon General to serve out the remainder of the council |
| 1776 | member's term. If the remainder of the replaced council member's |
| 1777 | term is less than 18 months, notwithstanding the provisions of |
| 1778 | this paragraph, the succeeding council member may be reappointed |
| 1779 | twice by the State Surgeon General. |
| 1780 | (c) The chair of the council is the State Surgeon General, |
| 1781 | who shall designate a vice chair from the membership of the |
| 1782 | council to serve in the absence of the State Surgeon General. A |
| 1783 | vacancy shall be filled for the remainder of the unexpired term |
| 1784 | in the same manner as the original appointment. |
| 1785 | (d) Council members are not entitled to receive |
| 1786 | compensation or reimbursement for per diem or travel expenses. |
| 1787 | (e) The council shall meet at least twice a year in person |
| 1788 | or by teleconference. |
| 1789 | (f) The council shall: |
| 1790 | 1. Advise the State Surgeon General and the department on |
| 1791 | matters concerning current and future physician workforce needs |
| 1792 | in this state; |
| 1793 | 2. Review survey materials and the compilation of survey |
| 1794 | information; |
| 1795 | 3. Annually review the number, location, cost, and |
| 1796 | reimbursement of graduate medical education programs and |
| 1797 | positions; |
| 1798 | 4. Provide recommendations to the department regarding the |
| 1799 | survey completed by physicians licensed under chapter 458 or |
| 1800 | chapter 459; |
| 1801 | 5. Assist the department in preparing the annual report to |
| 1802 | the Legislature pursuant to ss. 458.3192 and 459.0082; |
| 1803 | 6. Assist the department in preparing an initial strategic |
| 1804 | plan, conduct ongoing strategic planning in accordance with this |
| 1805 | section, and provide ongoing advice on implementing the |
| 1806 | recommendations; |
| 1807 | 7. Monitor and provide recommendations regarding the need |
| 1808 | for an increased number of primary care or other physician |
| 1809 | specialties to provide the necessary current and projected |
| 1810 | health and medical services for the state; and |
| 1811 | 8. Monitor and make recommendations regarding the status |
| 1812 | of the needs relating to graduate medical education in this |
| 1813 | state. |
| 1814 | Section 30. Section 458.3192, Florida Statutes, is amended |
| 1815 | to read: |
| 1816 | 458.3192 Analysis of survey results; report.- |
| 1817 | (1) Each year, the Department of Health shall analyze the |
| 1818 | results of the physician survey required by s. 458.3191 and |
| 1819 | determine by geographic area and specialty the number of |
| 1820 | physicians who: |
| 1821 | (a) Perform deliveries of children in this state Florida. |
| 1822 | (b) Read mammograms and perform breast-imaging-guided |
| 1823 | procedures in this state Florida. |
| 1824 | (c) Perform emergency care on an on-call basis for a |
| 1825 | hospital emergency department. |
| 1826 | (d) Plan to reduce or increase emergency on-call hours in |
| 1827 | a hospital emergency department. |
| 1828 | (e) Plan to relocate their allopathic or osteopathic |
| 1829 | practice 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 |
| 1833 | the Governor, the President of the Senate, and the Speaker of |
| 1834 | the House of Representatives by November 1 each year. The |
| 1835 | department shall also include in its report findings, |
| 1836 | recommendations, and strategic planning activities as provided |
| 1837 | in s. 381.4018. The department may also include other |
| 1838 | information requested by the Physician Workforce Advisory |
| 1839 | Council. |
| 1840 | Section 31. Section 459.0082, Florida Statutes, is amended |
| 1841 | to read: |
| 1842 | 459.0082 Analysis of survey results; report.- |
| 1843 | (1) Each year, the Department of Health shall analyze the |
| 1844 | results of the physician survey required by s. 459.0081 and |
| 1845 | determine by geographic area and specialty the number of |
| 1846 | physicians who: |
| 1847 | (a) Perform deliveries of children in this state Florida. |
| 1848 | (b) Read mammograms and perform breast-imaging-guided |
| 1849 | procedures in this state Florida. |
| 1850 | (c) Perform emergency care on an on-call basis for a |
| 1851 | hospital emergency department. |
| 1852 | (d) Plan to reduce or increase emergency on-call hours in |
| 1853 | a hospital emergency department. |
| 1854 | (e) Plan to relocate their allopathic or osteopathic |
| 1855 | practice 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 |
| 1859 | the Governor, the President of the Senate, and the Speaker of |
| 1860 | the House of Representatives by November 1 each year. The |
| 1861 | department shall also include in its report findings, |
| 1862 | recommendations, and strategic planning activities as provided |
| 1863 | in s. 381.4018. The department may also include other |
| 1864 | information requested by the Physician Workforce Advisory |
| 1865 | Council. |
| 1866 | Section 32. Section 458.315, Florida Statutes, is amended |
| 1867 | to read: |
| 1868 | 458.315 Temporary certificate for practice in areas of |
| 1869 | critical need.- |
| 1870 | (1) Any physician who: |
| 1871 | (a) Is licensed to practice in any jurisdiction in the |
| 1872 | United States and other state, whose license is currently valid; |
| 1873 | or, |
| 1874 | (b) Has served as a physician in the United States Armed |
| 1875 | Forces for at least 10 years and received an honorable discharge |
| 1876 | from the military; |
| 1877 |
|
| 1878 | and who pays an application fee of $300 may be issued a |
| 1879 | temporary certificate for to practice in areas of communities of |
| 1880 | Florida 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 |
| 1884 | department, correctional facility, Department of Veterans' |
| 1885 | Affairs clinic, community health center funded by s. 329, s. |
| 1886 | 330, or s. 340 of the United States Public Health Services Act, |
| 1887 | or other agency or institution that is approved by the State |
| 1888 | Surgeon General and provides health care to meet the needs of |
| 1889 | underserved populations in this state; or |
| 1890 | (c) Will practice for a limited time to address critical |
| 1891 | physician-specialty, demographic, or geographic needs for this |
| 1892 | state's physician workforce as determined by the State Surgeon |
| 1893 | General entity that provides health care to indigents and that |
| 1894 | is approved by the State Health Officer. |
| 1895 | (3) The Board of Medicine may issue this temporary |
| 1896 | certificate with the following restrictions: |
| 1897 | (a)(1) The State Surgeon General board shall determine the |
| 1898 | areas of critical need, and the physician so certified may |
| 1899 | practice in any of those areas for a time to be determined by |
| 1900 | the board. Such areas shall include, but are not be limited to, |
| 1901 | health professional shortage areas designated by the United |
| 1902 | States Department of Health and Human Services. |
| 1903 | 1.(a) A recipient of a temporary certificate for practice |
| 1904 | in areas of critical need may use the certificate license to |
| 1905 | work for any approved entity employer in any area of |
| 1906 | need or as authorized by the State Surgeon General approved by |
| 1907 | the board. |
| 1908 | 2.(b) The recipient of a temporary certificate for |
| 1909 | practice in areas of critical need shall, within 30 days after |
| 1910 | accepting employment, notify the board of all approved |
| 1911 | institutions in which the licensee practices and of all approved |
| 1912 | institutions where practice privileges have been denied. |
| 1913 | (b)(2) The board may administer an abbreviated oral |
| 1914 | examination to determine the physician's competency, but a no |
| 1915 | written regular examination is not required necessary. Within 60 |
| 1916 | days after receipt of an application for a temporary |
| 1917 | certificate, the board shall review the application and issue |
| 1918 | the temporary certificate, or notify the applicant of denial, or |
| 1919 | notify the applicant that the board recommends additional |
| 1920 | assessment, training, education, or other requirements as a |
| 1921 | condition of certification. If the applicant has not actively |
| 1922 | practiced during the prior 3 years and the board determines that |
| 1923 | the applicant may lack clinical competency, possess diminished |
| 1924 | or inadequate skills, lack necessary medical knowledge, or |
| 1925 | exhibit patterns of deficits in clinical decisionmaking, the |
| 1926 | board may: |
| 1927 | 1. Deny the application; |
| 1928 | 2. Issue a temporary certificate having reasonable |
| 1929 | restrictions that may include, but are not limited to, a |
| 1930 | requirement for the applicant to practice under the supervision |
| 1931 | of a physician approved by the board; or |
| 1932 | 3. Issue a temporary certificate upon receipt of |
| 1933 | documentation confirming that the applicant has met any |
| 1934 | reasonable conditions of the board which may include, but are |
| 1935 | not limited to, completing continuing education or undergoing an |
| 1936 | assessment of skills and training. |
| 1937 | (c)(3) Any certificate issued under this section is shall |
| 1938 | be valid only so long as the State Surgeon General determines |
| 1939 | that the reason area for which it was is issued remains a an |
| 1940 | area of critical need to the state. The Board of Medicine shall |
| 1941 | review each temporary certificateholder not the service within |
| 1942 | said area not less than annually to ascertain that the minimum |
| 1943 | requirements of the Medical Practice Act and its adopted the |
| 1944 | rules and regulations promulgated thereunder are being complied |
| 1945 | with. If it is determined that such minimum requirements are not |
| 1946 | being met, the board shall forthwith revoke such certificate or |
| 1947 | shall impose restrictions or conditions, or both, as a condition |
| 1948 | of continued practice under the certificate. |
| 1949 | (d)(4) The board may shall not issue a temporary |
| 1950 | certificate for practice in an area of critical need to any |
| 1951 | physician who is under investigation in any jurisdiction in the |
| 1952 | United States another state for an act that which would |
| 1953 | constitute a violation of this chapter until such time as the |
| 1954 | investigation is complete, at which time the provisions of s. |
| 1955 | 458.331 shall apply. |
| 1956 | (4)(5) The application fee and all licensure fees, |
| 1957 | including neurological injury compensation assessments, shall be |
| 1958 | waived for those persons obtaining a temporary certificate to |
| 1959 | practice in areas of critical need for the purpose of providing |
| 1960 | volunteer, uncompensated care for low-income residents |
| 1961 | Floridians. The applicant must submit an affidavit from the |
| 1962 | employing agency or institution stating that the physician will |
| 1963 | not receive any compensation for any service involving the |
| 1964 | practice of medicine. |
| 1965 | Section 33. Section 459.0076, Florida Statutes, is created |
| 1966 | to read: |
| 1967 | 459.0076 Temporary certificate for practice in areas of |
| 1968 | critical need.- |
| 1969 | (1) Any physician who: |
| 1970 | (a) Is licensed to practice in any jurisdiction in the |
| 1971 | United States and whose license is currently valid; or |
| 1972 | (b) Has served as a physician in the United States Armed |
| 1973 | Forces for at least 10 years and received an honorable discharge |
| 1974 | from the military; |
| 1975 |
|
| 1976 | and who pays an application fee of $300 may be issued a |
| 1977 | temporary 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 |
| 1981 | department, correctional facility, Department of Veterans' |
| 1982 | Affairs clinic, community health center funded by s. 329, s. |
| 1983 | 330, or s. 340 of the United States Public Health Services Act, |
| 1984 | or other agency or institution that is approved by the State |
| 1985 | Surgeon General and provides health care to meet the needs of |
| 1986 | underserved populations in this state; or |
| 1987 | (c) Will practice for a limited time to address critical |
| 1988 | physician-specialty, demographic, or geographic needs for this |
| 1989 | state's physician workforce as determined by the State Surgeon |
| 1990 | General. |
| 1991 | (3) The Board of Osteopathic Medicine may issue this |
| 1992 | temporary certificate with the following restrictions: |
| 1993 | (a) The State Surgeon General shall determine the areas of |
| 1994 | critical need. Such areas include, but are not limited to, |
| 1995 | health professional shortage areas designated by the United |
| 1996 | States Department of Health and Human Services. |
| 1997 | 1. A recipient of a temporary certificate for practice in |
| 1998 | areas of critical need may use the certificate to work for any |
| 1999 | approved entity in any area of critical need or as authorized by |
| 2000 | the State Surgeon General. |
| 2001 | 2. The recipient of a temporary certificate for practice |
| 2002 | in areas of critical need shall, within 30 days after accepting |
| 2003 | employment, notify the board of all approved institutions in |
| 2004 | which the licensee practices and of all approved institutions |
| 2005 | where practice privileges have been denied. |
| 2006 | (b) The board may administer an abbreviated oral |
| 2007 | examination to determine the physician's competency, but a |
| 2008 | written regular examination is not required. Within 60 days |
| 2009 | after receipt of an application for a temporary certificate, the |
| 2010 | board shall review the application and issue the temporary |
| 2011 | certificate, notify the applicant of denial, or notify the |
| 2012 | applicant that the board recommends additional assessment, |
| 2013 | training, education, or other requirements as a condition of |
| 2014 | certification. If the applicant has not actively practiced |
| 2015 | during the prior 3 years and the board determines that the |
| 2016 | applicant may lack clinical competency, possess diminished or |
| 2017 | inadequate skills, lack necessary medical knowledge, or exhibit |
| 2018 | patterns of deficits in clinical decisionmaking, the board may: |
| 2019 | 1. Deny the application; |
| 2020 | 2. Issue a temporary certificate having reasonable |
| 2021 | restrictions that may include, but are not limited to, a |
| 2022 | requirement for the applicant to practice under the supervision |
| 2023 | of a physician approved by the board; or |
| 2024 | 3. Issue a temporary certificate upon receipt of |
| 2025 | documentation confirming that the applicant has met any |
| 2026 | reasonable conditions of the board which may include, but are |
| 2027 | not limited to, completing continuing education or undergoing an |
| 2028 | assessment of skills and training. |
| 2029 | (c) Any certificate issued under this section is valid |
| 2030 | only so long as the State Surgeon General determines that the |
| 2031 | reason for which it was issued remains a critical need to the |
| 2032 | state. The Board of Osteopathic Medicine shall review each |
| 2033 | temporary certificateholder not less than annually to ascertain |
| 2034 | that the minimum requirements of the Osteopathic Medical |
| 2035 | Practice Act and its adopted rules are being complied with. If |
| 2036 | it is determined that such minimum requirements are not being |
| 2037 | met, the board shall revoke such certificate or shall impose |
| 2038 | restrictions or conditions, or both, as a condition of continued |
| 2039 | practice under the certificate. |
| 2040 | (d) The board may not issue a temporary certificate for |
| 2041 | practice in an area of critical need to any physician who is |
| 2042 | under investigation in any jurisdiction in the United States for |
| 2043 | an act that would constitute a violation of this chapter until |
| 2044 | such time as the investigation is complete, at which time the |
| 2045 | provisions of s. 459.015 apply. |
| 2046 | (4) The application fee and all licensure fees, including |
| 2047 | neurological injury compensation assessments, shall be waived |
| 2048 | for those persons obtaining a temporary certificate to practice |
| 2049 | in areas of critical need for the purpose of providing |
| 2050 | volunteer, uncompensated care for low-income residents. The |
| 2051 | applicant must submit an affidavit from the employing agency or |
| 2052 | institution stating that the physician will not receive any |
| 2053 | compensation for any service involving the practice of medicine. |
| 2054 | Section 34. (1) The Department of Health shall conduct an |
| 2055 | evaluation and justification review of each division established |
| 2056 | under s. 20.43, Florida Statutes. The review shall be |
| 2057 | comprehensive in its scope and, at a minimum, must be conducted |
| 2058 | in such a manner as to specifically determine the following, and |
| 2059 | to consider and determine what changes, if any, are needed with |
| 2060 | respect thereto: |
| 2061 | (a) The identifiable cost of each division and programs |
| 2062 | within the division. |
| 2063 | (b) The specific purpose of each division and programs |
| 2064 | within the division, and the specific public health benefit |
| 2065 | derived therefrom. |
| 2066 | (c) Progress toward achieving the outputs and outcomes |
| 2067 | associated with each division and programs within the division. |
| 2068 | (d) An explanation of circumstances contributing to the |
| 2069 | department's ability to achieve, not achieve, or exceed its |
| 2070 | projected outputs and outcomes, as defined in s. 216.011, |
| 2071 | associated with each division and programs within the division. |
| 2072 | (e) Alternate courses of action that would result in |
| 2073 | administration of the same program in a more efficient or |
| 2074 | effective manner. The courses of action to be considered must |
| 2075 | include, but are not limited to: |
| 2076 | 1. Whether the department could be organized in a more |
| 2077 | efficient and effective manner, including whether each |
| 2078 | division's mission, goals, or objectives should be redefined. |
| 2079 | The report must include a rationale for each department division |
| 2080 | and programs within the division, the return on investment of |
| 2081 | each division and programs within the division, the relatedness |
| 2082 | of the division and programs within the division to a public |
| 2083 | health function, and any federal funding support for each |
| 2084 | division and programs within the division. The review should |
| 2085 | recommend the reduction and restructuring of department bureaus |
| 2086 | and divisions. |
| 2087 | 2. Whether the division and programs within the division |
| 2088 | could be administered more efficiently or effectively to avoid |
| 2089 | duplication of activities and ensure that activities are |
| 2090 | adequately coordinated. |
| 2091 | 3. Whether the division and programs within that division |
| 2092 | could be performed more efficiently or more effectively by |
| 2093 | another unit of government or a private entity. |
| 2094 | 4. When compared to costs, whether effectiveness warrants |
| 2095 | elimination of the division or programs within the division or, |
| 2096 | if the division or a program within the division serves a |
| 2097 | limited interest, whether the division or program should be |
| 2098 | redesigned to require users to finance program costs. |
| 2099 | 5. Whether the cost to administer the division or program |
| 2100 | within the division exceeds license and other fee revenues paid |
| 2101 | by those being regulated. |
| 2102 | 6. Whether other changes could improve the efficiency and |
| 2103 | effectiveness of the division or program within the division. |
| 2104 | (f) The consequences of discontinuing such division or |
| 2105 | programs within the division. If any discontinuation is |
| 2106 | recommended, such recommendation must be accompanied by a |
| 2107 | description of alternatives to implement such recommendation, |
| 2108 | including an implementation schedule for discontinuation and |
| 2109 | recommended procedures for assisting state agency employees |
| 2110 | affected by the discontinuation. |
| 2111 | (g) Whether current performance measures and standards |
| 2112 | should be reviewed or amended to assist department efforts in |
| 2113 | achieving outputs and outcome measures. |
| 2114 | (h) Whether the information reported as part of the |
| 2115 | state's performance-based program budgeting system has relevance |
| 2116 | and utility for the evaluation of each division and programs |
| 2117 | within the division. |
| 2118 | (i) Whether department management has established control |
| 2119 | systems sufficient to ensure that performance data are |
| 2120 | maintained and supported by department records and accurately |
| 2121 | presented in department performance reports. |
| 2122 | (3) No later than March 1, 2011, the department shall |
| 2123 | submit a report on its evaluation and justification review |
| 2124 | findings and recommendations to the President of the Senate, the |
| 2125 | Speaker of the House of Representatives, the chairs of the |
| 2126 | appropriate substantive committees, the chairs of the |
| 2127 | appropriations committees, the Legislative Auditing Committee, |
| 2128 | the Governor, and the State Surgeon General. |
| 2129 | Section 35. Subsection (3) is added to section 381.00315, |
| 2130 | Florida Statutes, to read: |
| 2131 | 381.00315 Public health advisories; public health |
| 2132 | emergencies.-The State Health Officer is responsible for |
| 2133 | declaring public health emergencies and issuing public health |
| 2134 | advisories. |
| 2135 | (3) To facilitate effective emergency management, when the |
| 2136 | United States Department of Health and Human Services contracts |
| 2137 | for the manufacture and delivery of licensable products in |
| 2138 | response to a public health emergency and the terms of those |
| 2139 | contracts are made available to the states, the department shall |
| 2140 | accept funds provided by counties, municipalities, and other |
| 2141 | entities designated in the state emergency management plan |
| 2142 | required under s. 252.35(2)(a) for the purpose of participation |
| 2143 | in those contracts. The department shall deposit those funds in |
| 2144 | the Grants and Donations Trust Fund and expend those funds on |
| 2145 | behalf of the donor county, municipality, or other entity for |
| 2146 | the purchase of the licensable products made available under the |
| 2147 | contract. |
| 2148 | Section 36. For fiscal year 2010-2011 only, and |
| 2149 | notwithstanding s. 216.181, Florida Statutes, the Department of |
| 2150 | Health is authorized to submit a budget amendment requesting |
| 2151 | additional Grants and Donations Trust Fund budget authority for |
| 2152 | the Florida Center for Nursing to make expenditures supported by |
| 2153 | grants and donations. |
| 2154 | Section 37. Paragraph (a) of subsection (1) of section |
| 2155 | 409.9201, 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 |
| 2159 | limited to, finished dosage forms or active ingredients that are |
| 2160 | subject to, defined by, or described by s. 503(b) of the Federal |
| 2161 | Food, Drug, and Cosmetic Act or by s. 465.003(8), s. |
| 2162 | 499.003(46)(45) or (53) (52), or s. 499.007(13). |
| 2163 |
|
| 2164 | The value of individual items of the legend drugs or goods or |
| 2165 | services involved in distinct transactions committed during a |
| 2166 | single scheme or course of conduct, whether involving a single |
| 2167 | person or several persons, may be aggregated when determining |
| 2168 | the punishment for the offense. |
| 2169 | Section 38. Subsection (3) of section 465.0265, Florida |
| 2170 | Statutes, is amended to read: |
| 2171 | 465.0265 Centralized prescription filling.- |
| 2172 | (3) The filling, delivery, and return of a prescription by |
| 2173 | one pharmacy for another pursuant to this section shall not be |
| 2174 | construed as the filling of a transferred prescription as set |
| 2175 | forth in s. 465.026 or as a wholesale distribution as set forth |
| 2176 | in s. 499.003(54)(53). |
| 2177 | Section 39. Paragraph (g) of subsection (2) of section |
| 2178 | 499.01, 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 |
| 2182 | restricted prescription drug distributor permit is required for |
| 2183 | any person that engages in the distribution of a prescription |
| 2184 | drug, which distribution is not considered "wholesale |
| 2185 | distribution" under s. 499.003(54)(53)(a). |
| 2186 | 1. A person who engages in the receipt or distribution of |
| 2187 | a prescription drug in this state for the purpose of processing |
| 2188 | its return or its destruction must obtain a permit as a |
| 2189 | restricted prescription drug distributor if such person is not |
| 2190 | the person initiating the return, the prescription drug |
| 2191 | wholesale supplier of the person initiating the return, or the |
| 2192 | manufacturer of the drug. |
| 2193 | 2. Storage, handling, and recordkeeping of these |
| 2194 | distributions must comply with the requirements for wholesale |
| 2195 | distributors under s. 499.0121, but not those set forth in s. |
| 2196 | 499.01212. |
| 2197 | 3. A person who applies for a permit as a restricted |
| 2198 | prescription drug distributor, or for the renewal of such a |
| 2199 | permit, must provide to the department the information required |
| 2200 | under s. 499.012. |
| 2201 | 4. The department may adopt rules regarding the |
| 2202 | distribution of prescription drugs by hospitals, health care |
| 2203 | entities, charitable organizations, or other persons not |
| 2204 | involved in wholesale distribution, which rules are necessary |
| 2205 | for the protection of the public health, safety, and welfare. |
| 2206 | Section 40. Paragraph (d) of subsection (4) of section |
| 2207 | 499.0121, Florida Statutes, is amended to read: |
| 2208 | 499.0121 Storage and handling of prescription drugs; |
| 2209 | recordkeeping.-The department shall adopt rules to implement |
| 2210 | this section as necessary to protect the public health, safety, |
| 2211 | and welfare. Such rules shall include, but not be limited to, |
| 2212 | requirements for the storage and handling of prescription drugs |
| 2213 | and for the establishment and maintenance of prescription drug |
| 2214 | distribution records. |
| 2215 | (4) EXAMINATION OF MATERIALS AND RECORDS.- |
| 2216 | (d) Upon receipt, a wholesale distributor must review |
| 2217 | records required under this section for the acquisition of |
| 2218 | prescription drugs for accuracy and completeness, considering |
| 2219 | the total facts and circumstances surrounding the transactions |
| 2220 | and the wholesale distributors involved. This includes |
| 2221 | authenticating each transaction listed on a pedigree paper, as |
| 2222 | defined in s. 499.003(37)(36). |
| 2223 | Section 41. Paragraphs (a) and (b) of subsection (2) of |
| 2224 | section 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 |
| 2227 | the Secretary of Health Care Administration, or her or his |
| 2228 | designee, shall be members of the council. The State Surgeon |
| 2229 | General shall appoint nine additional members to the council who |
| 2230 | shall be appointed to a term of 4 years each, as follows: |
| 2231 | (a) Three different persons each of whom is employed by a |
| 2232 | different prescription drug wholesale distributor licensed under |
| 2233 | this part which operates nationally and is a primary wholesale |
| 2234 | distributor, as defined in s. 499.003(47)(46). |
| 2235 | (b) One person employed by a prescription drug wholesale |
| 2236 | distributor licensed under this part which is a secondary |
| 2237 | wholesale distributor, as defined in s. 499.003(52)(51). |
| 2238 | Section 42. Subsection (1) of section 499.03, Florida |
| 2239 | Statutes, is amended to read: |
| 2240 | 499.03 Possession of certain drugs without prescriptions |
| 2241 | unlawful; exemptions and exceptions.- |
| 2242 | (1) A person may not possess, or possess with intent to |
| 2243 | sell, dispense, or deliver, any habit-forming, toxic, harmful, |
| 2244 | or new drug subject to s. 499.003(33)(32), or prescription drug |
| 2245 | as defined in s. 499.003(43)(42), unless the possession of the |
| 2246 | drug has been obtained by a valid prescription of a practitioner |
| 2247 | licensed by law to prescribe the drug. However, this section |
| 2248 | does not apply to the delivery of such drugs to persons included |
| 2249 | in any of the classes named in this subsection, or to the agents |
| 2250 | or employees of such persons, for use in the usual course of |
| 2251 | their businesses or practices or in the performance of their |
| 2252 | official duties, as the case may be; nor does this section apply |
| 2253 | to the possession of such drugs by those persons or their agents |
| 2254 | or employees for such use: |
| 2255 | (a) A licensed pharmacist or any person under the licensed |
| 2256 | pharmacist's supervision while acting within the scope of the |
| 2257 | licensed pharmacist's practice; |
| 2258 | (b) A licensed practitioner authorized by law to prescribe |
| 2259 | prescription drugs or any person under the licensed |
| 2260 | practitioner's supervision while acting within the scope of the |
| 2261 | licensed practitioner's practice; |
| 2262 | (c) A qualified person who uses prescription drugs for |
| 2263 | lawful research, teaching, or testing, and not for resale; |
| 2264 | (d) A licensed hospital or other institution that procures |
| 2265 | such drugs for lawful administration or dispensing by |
| 2266 | practitioners; |
| 2267 | (e) An officer or employee of a federal, state, or local |
| 2268 | government; or |
| 2269 | (f) A person that holds a valid permit issued by the |
| 2270 | department pursuant to this part which authorizes that person to |
| 2271 | possess prescription drugs. |
| 2272 | Section 43. Paragraphs (i) and (m) of subsection (1) of |
| 2273 | section 499.05, Florida Statutes, are amended to read: |
| 2274 | 499.05 Rules.- |
| 2275 | (1) The department shall adopt rules to implement and |
| 2276 | enforce this part with respect to: |
| 2277 | (i) Additional conditions that qualify as an emergency |
| 2278 | medical reason under s. 499.003(54)(53)(b)2. |
| 2279 | (m) The recordkeeping, storage, and handling with respect |
| 2280 | to each of the distributions of prescription drugs specified in |
| 2281 | s. 499.003(54)(53)(a)-(d). |
| 2282 | Section 44. Subsection (1) of section 794.075, Florida |
| 2283 | Statutes, is amended to read: |
| 2284 | 794.075 Sexual predators; erectile dysfunction drugs.- |
| 2285 | (1) A person may not possess a prescription drug, as |
| 2286 | defined in s. 499.003(43)(42), for the purpose of treating |
| 2287 | erectile dysfunction if the person is designated as a sexual |
| 2288 | predator under s. 775.21. |
| 2289 | Section 45. Except as otherwise expressly provided in this |
| 2290 | act, this act shall take effect July 1, 2010. |