Bill Text: FL S1192 | 2013 | Regular Session | Comm Sub
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Provision of Health Care with Controlled Substances
Spectrum: Slight Partisan Bill (? 3-1)
Status: (Failed) 2013-05-03 - Died in Messages [S1192 Detail]
Download: Florida-2013-S1192-Comm_Sub.html
Bill Title: Provision of Health Care with Controlled Substances
Spectrum: Slight Partisan Bill (? 3-1)
Status: (Failed) 2013-05-03 - Died in Messages [S1192 Detail]
Download: Florida-2013-S1192-Comm_Sub.html
Florida Senate - 2013 CS for CS for SB 1192 By the Committees on Community Affairs; and Health Policy; and Senator Grimsley 578-04007A-13 20131192c2 1 A bill to be entitled 2 An act relating to the provision of health care with 3 controlled substances; amending s. 456.44, F.S.; 4 limiting the application of requirements for 5 prescribing controlled substances; requiring a 6 physician to consult the prescription drug monitoring 7 program database before prescribing certain controlled 8 substances; authorizing the appropriate board to adopt 9 a penalty for failure to consult the database; 10 exempting nursing home residents and certain 11 physicians from requirements regarding prescriptions 12 of controlled substances; amending s. 465.003, F.S.; 13 defining a term; conforming a cross-reference; 14 creating s. 465.0065, F.S.; providing notice 15 requirements for inspection of a pharmacy; amending s. 16 465.016, F.S.; providing additional grounds for 17 disciplinary action; conforming a cross-reference; 18 amending s. 465.022, F.S.; conforming a cross 19 reference; requiring a pharmacy permittee to commence 20 operations within 180 days after permit issuance or 21 show good cause why operations were not commenced; 22 requiring the Board of Pharmacy to establish rules; 23 requiring a pharmacy permittee to be supervised by a 24 prescription department manager or consultant 25 pharmacist of record; amending s. 465.023, F.S.; 26 providing additional grounds for disciplinary action; 27 conforming a cross-reference; creating s. 465.1902, 28 F.S.; providing that regulation of the licensure, 29 activity, and operation of pharmacies and pharmacists 30 is preempted to the state; prohibiting a local 31 government or political subdivision of the state from 32 enacting or enforcing an ordinance that imposes a 33 levy, charge, or fee upon, or that otherwise 34 regulates, pharmacies and pharmacists, except for 35 ordinances regarding local business taxes and land 36 development; amending s. 893.055, F.S.; deleting an 37 obsolete provision; deleting a provision that 38 prohibits funds from prescription drug manufacturers 39 to be used to implement the prescription drug 40 monitoring program; authorizing the prescription drug 41 monitoring program to be funded by state funds; 42 revising the sources of money which are inappropriate 43 for the direct-support organization of the 44 prescription drug monitoring program to receive; 45 creating s. 893.0552, F.S.; providing that regulation 46 of the licensure, activity, and operation of pain 47 management clinics is preempted to the state under 48 certain circumstances; authorizing a local government 49 or political subdivision of the state to enact certain 50 ordinances regarding local business taxes and land 51 development; amending ss. 409.9201, 458.331, 459.015, 52 465.014, 465.015, 465.0156, 465.0197, 465.1901, 53 499.003, and 893.02, F.S.; conforming cross 54 references; providing an effective date. 55 56 Be It Enacted by the Legislature of the State of Florida: 57 58 Section 1. Subsections (2) and (3) of section 456.44, 59 Florida Statutes, are amended to read: 60 456.44 Controlled substance prescribing.— 61 (2) REGISTRATION.—Effective January 1, 2012,A physician 62 licensed under chapter 458, chapter 459, chapter 461, or chapter 63 466 who prescribes more than a 30-day supply of any controlled 64 substance, listed in Schedule II, Schedule III, or Schedule IV 65 as defined in s. 893.03, over a 6-month period to any one 66 patient for the treatment of chronic nonmalignant pain, must: 67 (a) Designate himself or herself as a controlled substance 68 prescribing practitioner on the physician’s practitioner 69 profile. 70 (b) Comply with the requirements of this section and 71 applicable board rules. 72 (3) STANDARDS OF PRACTICE.—The standards of practice in 73 this section do not supersede the level of care, skill, and 74 treatment recognized in general law related to health care 75 licensure. 76 (a) A complete medical history and a physical examination 77 must be conducted before beginning any treatment and must be 78 documented in the medical record. The exact components of the 79 physical examination shall be left to the judgment of the 80 clinician who is expected to perform a physical examination 81 proportionate to the diagnosis that justifies a treatment. The 82 medical record must, at a minimum, document the nature and 83 intensity of the pain, current and past treatments for pain, 84 underlying or coexisting diseases or conditions, the effect of 85 the pain on physical and psychological function, a review of 86 previous medical records, previous diagnostic studies, and 87 history of alcohol and substance abuse. The medical record shall 88 also document the presence of one or more recognized medical 89 indications for the use of a controlled substance. Each 90 registrant must develop a written plan for assessing each 91 patient’s risk of aberrant drug-related behavior, which may 92 include patient drug testing. Registrants must assess each 93 patient’s risk for aberrant drug-related behavior and monitor 94 that risk on an ongoing basis in accordance with the plan. 95 (b) Before or during a new patient’s visit for pain 96 treatment services at a pain-management clinic registered under 97 s. 458.3265 or s. 459.0137, a physician shall consult the 98 prescription drug monitoring program database provided under s. 99 893.055(2)(a) before prescribing a controlled substance listed 100 in Schedule II or Schedule III in s. 893.03. The physician may 101 designate an agent under his or her supervision to consult the 102 database. The board shall adopt rules to establish a penalty for 103 a physician who does not comply with this subsection. 104 (c)(b)Each registrant must develop a written 105 individualized treatment plan for each patient. The treatment 106 plan shall state objectives that will be used to determine 107 treatment success, such as pain relief and improved physical and 108 psychosocial function, and shall indicate if any further 109 diagnostic evaluations or other treatments are planned. After 110 treatment begins, the physician shall adjust drug therapy to the 111 individual medical needs of each patient. Other treatment 112 modalities, including a rehabilitation program, shall be 113 considered depending on the etiology of the pain and the extent 114 to which the pain is associated with physical and psychosocial 115 impairment. The interdisciplinary nature of the treatment plan 116 shall be documented. 117 (d)(c)The physician shall discuss the risks and benefits 118 of the use of controlled substances, including the risks of 119 abuse and addiction, as well as physical dependence and its 120 consequences, with the patient, persons designated by the 121 patient, or the patient’s surrogate or guardian if the patient 122 is incompetent. The physician shall use a written controlled 123 substance agreement between the physician and the patient 124 outlining the patient’s responsibilities, including, but not 125 limited to: 126 1. Number and frequency of controlled substance 127 prescriptions and refills. 128 2. Patient compliance and reasons for which drug therapy 129 may be discontinued, such as a violation of the agreement. 130 3. An agreement that controlled substances for the 131 treatment of chronic nonmalignant pain shall be prescribed by a 132 single treating physician unless otherwise authorized by the 133 treating physician and documented in the medical record. 134 (e)(d)The patient shall be seen by the physician at 135 regular intervals, not to exceed 3 months, to assess the 136 efficacy of treatment, ensure that controlled substance therapy 137 remains indicated, evaluate the patient’s progress toward 138 treatment objectives, consider adverse drug effects, and review 139 the etiology of the pain. Continuation or modification of 140 therapy shall depend on the physician’s evaluation of the 141 patient’s progress. If treatment goals are not being achieved, 142 despite medication adjustments, the physician shall reevaluate 143 the appropriateness of continued treatment. The physician shall 144 monitor patient compliance in medication usage, related 145 treatment plans, controlled substance agreements, and 146 indications of substance abuse or diversion at a minimum of 3 147 month intervals. 148 (f)(e)The physician shall refer the patient as necessary 149 for additional evaluation and treatment in order to achieve 150 treatment objectives. Special attention shall be given to those 151 patients who are at risk for misusing their medications and 152 those whose living arrangements pose a risk for medication 153 misuse or diversion. The management of pain in patients with a 154 history of substance abuse or with a comorbid psychiatric 155 disorder requires extra care, monitoring, and documentation and 156 requires consultation with or referral to an addiction medicine 157 specialist or psychiatrist. 158 (g)(f)A physician registered under this section must 159 maintain accurate, current, and complete records that are 160 accessible and readily available for review and comply with the 161 requirements of this section, the applicable practice act, and 162 applicable board rules. The medical records must include, but 163 are not limited to: 164 1. The complete medical history and a physical examination, 165 including history of drug abuse or dependence. 166 2. Diagnostic, therapeutic, and laboratory results. 167 3. Evaluations and consultations. 168 4. Treatment objectives. 169 5. Discussion of risks and benefits. 170 6. Treatments. 171 7. Medications, including date, type, dosage, and quantity 172 prescribed. 173 8. Instructions and agreements. 174 9. Periodic reviews. 175 10. Results of any drug testing. 176 11. A photocopy of the patient’s government-issued photo 177 identification. 178 12. If a written prescription for a controlled substance is 179 given to the patient, a duplicate of the prescription. 180 13. The physician’s full name presented in a legible 181 manner. 182 (h)(g)Patients with signs or symptoms of substance abuse 183 shall be immediately referred to a board-certified pain 184 management physician, an addiction medicine specialist, or a 185 mental health addiction facility as it pertains to drug abuse or 186 addiction unless the physician is board-certified or board 187 eligible in pain management. Throughout the period of time 188 before receiving the consultant’s report, a prescribing 189 physician shall clearly and completely document medical 190 justification for continued treatment with controlled substances 191 and those steps taken to ensure medically appropriate use of 192 controlled substances by the patient. Upon receipt of the 193 consultant’s written report, the prescribing physician shall 194 incorporate the consultant’s recommendations for continuing, 195 modifying, or discontinuing controlled substance therapy. The 196 resulting changes in treatment shall be specifically documented 197 in the patient’s medical record. Evidence or behavioral 198 indications of diversion shall be followed by discontinuation of 199 controlled substance therapy, and the patient shall be 200 discharged, and all results of testing and actions taken by the 201 physician shall be documented in the patient’s medical record. 202 203 This subsection does not apply to a board-eligible or board 204 certified anesthesiologist, physiatrist, rheumatologist, or 205 neurologist, or to a board-certified physician who has surgical 206 privileges at a hospital or ambulatory surgery center and 207 primarily provides surgical services. This subsection does not 208 apply to a board-eligible or board-certified medical specialist 209 who has also completed a fellowship in pain medicine approved by 210 the Accreditation Council for Graduate Medical Education or the 211 American Osteopathic Association, or who is board eligible or 212 board certified in pain medicine by the American Board of Pain 213 Medicine or a board approved by the American Board of Medical 214 Specialties or the American Osteopathic Association and performs 215 interventional pain procedures of the type routinely billed 216 using surgical codes. This subsection does not apply to a 217 physician who prescribes medically necessary controlled 218 substances for a patient during an inpatient stay in a hospital 219 licensed under chapter 395 or to a resident in a facility 220 licensed under part II of chapter 400. This subsection does not 221 apply to any physician licensed under chapter 458 or chapter 459 222 who writes fewer than 50 prescriptions for a controlled 223 substance for all of his or her patients during a 1-year period. 224 Section 2. Present subsections (1) through (17) of section 225 465.003, Florida Statutes, are renumbered as subsections (2) 226 through (18), respectively, paragraph (a) of present subsection 227 (11) of that section is amended, and a new subsection (1) is 228 added to that section, to read: 229 465.003 Definitions.—As used in this chapter, the term: 230 (1) “Abandoned” means the status of a pharmacy permit of a 231 person or entity that was issued the permit but fails to 232 commence pharmacy operations within 180 days after issuance of 233 the permit without good cause or fails to follow pharmacy 234 closure requirements as set by the board. 235 (12)(11)(a) “Pharmacy” includes a community pharmacy, an 236 institutional pharmacy, a nuclear pharmacy, a special pharmacy, 237 and an Internet pharmacy. 238 1. The term “community pharmacy” includes every location 239 where medicinal drugs are compounded, dispensed, stored, or sold 240 or where prescriptions are filled or dispensed on an outpatient 241 basis. 242 2. The term “institutional pharmacy” includes every 243 location in a hospital, clinic, nursing home, dispensary, 244 sanitarium, extended care facility, or other facility, 245 hereinafter referred to as “health care institutions,” where 246 medicinal drugs are compounded, dispensed, stored, or sold. 247 3. The term “nuclear pharmacy” includes every location 248 where radioactive drugs and chemicals within the classification 249 of medicinal drugs are compounded, dispensed, stored, or sold. 250 The term “nuclear pharmacy” does not include hospitals licensed 251 under chapter 395 or the nuclear medicine facilities of such 252 hospitals. 253 4. The term “special pharmacy” includes every location 254 where medicinal drugs are compounded, dispensed, stored, or sold 255 if such locations are not otherwise defined in this subsection. 256 5. The term “Internet pharmacy” includes locations not 257 otherwise licensed or issued a permit under this chapter, within 258 or outside this state, which use the Internet to communicate 259 with or obtain information from consumers in this state and use 260 such communication or information to fill or refill 261 prescriptions or to dispense, distribute, or otherwise engage in 262 the practice of pharmacy in this state. Any act described in 263 this definition constitutes the practice of pharmacy as defined 264 in subsection (14)(13). 265 Section 3. Section 465.0065, Florida Statutes, is created 266 to read: 267 465.0065 Notices; form and service.—Each notice served by 268 the department pursuant to this chapter must be in writing and 269 must be delivered personally by an agent of the department or by 270 certified mail to the pharmacy permittee or licensee. If the 271 pharmacy permittee or licensee refuses to accept service or 272 evades service or if the agent is otherwise unable to carry out 273 service after due diligence, the department may post the notice 274 in a conspicuous place at the pharmacy or at the home or 275 business address for the licensee. 276 Section 4. Paragraphs (e) and (s) of subsection (1) of 277 section 465.016, Florida Statutes, are amended, and paragraph 278 (u) is added to that subsection, to read: 279 465.016 Disciplinary actions.— 280 (1) The following acts constitute grounds for denial of a 281 license or disciplinary action, as specified in s. 456.072(2): 282 (e) Violating chapter 499; 21 U.S.C. ss. 301-392, known as 283 the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et 284 seq., known as the Comprehensive Drug Abuse Prevention and 285 Control Act; or chapter 893 or rules adopted thereunder. 286 (s) Dispensing any medicinal drug based upon a 287 communication that purports to be a prescription as defined by 288 s. 465.003s.465.003(14)or s. 893.02 when the pharmacist knows 289 or has reason to believe that the purported prescription is not 290 based upon a valid practitioner-patient relationship. 291 (u) Misappropriating drugs, supplies, or equipment from a 292 pharmacy permittee. 293 Section 5. Paragraph (j) of subsection (5) of section 294 465.022, Florida Statutes, is amended, present subsections (10) 295 through (14) are renumbered as subsections (11) through (15), 296 respectively, present subsection (10) of that section is 297 amended, and a new subsection (10) is added to that section, to 298 read: 299 465.022 Pharmacies; general requirements; fees.— 300 (5) The department or board shall deny an application for a 301 pharmacy permit if the applicant or an affiliated person, 302 partner, officer, director, or prescription department manager 303 or consultant pharmacist of record of the applicant: 304 (j) Has dispensed any medicinal drug based upon a 305 communication that purports to be a prescription as defined by 306 s. 465.003s.465.003(14)or s. 893.02 when the pharmacist knows 307 or has reason to believe that the purported prescription is not 308 based upon a valid practitioner-patient relationship that 309 includes a documented patient evaluation, including history and 310 a physical examination adequate to establish the diagnosis for 311 which any drug is prescribed and any other requirement 312 established by board rule under chapter 458, chapter 459, 313 chapter 461, chapter 463, chapter 464, or chapter 466. 314 315 For felonies in which the defendant entered a plea of guilty or 316 nolo contendere in an agreement with the court to enter a 317 pretrial intervention or drug diversion program, the department 318 shall deny the application if upon final resolution of the case 319 the licensee has failed to successfully complete the program. 320 (10) The permittee shall commence pharmacy operations 321 within 180 days after issuance of the permit, or show good cause 322 to the department why pharmacy operations were not commenced. 323 Commencement of pharmacy operations includes, but is not limited 324 to, acts within the scope of the practice of pharmacy, ordering 325 or receiving drugs, and other similar activities. The board 326 shall establish rules regarding commencement of pharmacy 327 operations. 328 (11)(10)A pharmacy permittee shall be supervised by a 329 prescription department manager or consultant pharmacist of 330 record at all times. A permittee must notify the department, on 331 a form approved by the board, within 10 days after any change in 332 prescription department manager or consultant pharmacist of 333 record. 334 Section 6. Subsection (1) of section 465.023, Florida 335 Statutes, is amended to read: 336 465.023 Pharmacy permittee; disciplinary action.— 337 (1) The department or the board may revoke or suspend the 338 permit of any pharmacy permittee, and may fine, place on 339 probation, or otherwise discipline any pharmacy permittee if the 340 permittee, or any affiliated person, partner, officer, director, 341 or agent of the permittee, including a person fingerprinted 342 under s. 465.022(3), has: 343 (a) Obtained a permit by misrepresentation or fraud or 344 through an error of the department or the board; 345 (b) Attempted to procure, or has procured, a permit for any 346 other person by making, or causing to be made, any false 347 representation; 348 (c) Violated any of the requirements of this chapter or any 349 of the rules of the Board of Pharmacy; of chapter 499, known as 350 the “Florida Drug and Cosmetic Act”; of 21 U.S.C. ss. 301-392, 351 known as the “Federal Food, Drug, and Cosmetic Act”; of 21 352 U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse 353 Prevention and Control Act; or of chapter 893 or rules adopted 354 thereunder; 355 (d) Been convicted or found guilty, regardless of 356 adjudication, of a felony or any other crime involving moral 357 turpitude in any of the courts of this state, of any other 358 state, or of the United States; 359 (e) Been convicted or disciplined by a regulatory agency of 360 the Federal Government or a regulatory agency of another state 361 for any offense that would constitute a violation of this 362 chapter; 363 (f) Been convicted of, or entered a plea of guilty or nolo 364 contendere to, regardless of adjudication, a crime in any 365 jurisdiction which relates to the practice of, or the ability to 366 practice, the profession of pharmacy; 367 (g) Been convicted of, or entered a plea of guilty or nolo 368 contendere to, regardless of adjudication, a crime in any 369 jurisdiction which relates to health care fraud; or 370 (h) Dispensed any medicinal drug based upon a communication 371 that purports to be a prescription as defined by s. 465.003s.372465.003(14)or s. 893.02 when the pharmacist knows or has reason 373 to believe that the purported prescription is not based upon a 374 valid practitioner-patient relationship that includes a 375 documented patient evaluation, including history and a physical 376 examination adequate to establish the diagnosis for which any 377 drug is prescribed and any other requirement established by 378 board rule under chapter 458, chapter 459, chapter 461, chapter 379 463, chapter 464, or chapter 466. 380 Section 7. Section 465.1902, Florida Statutes, is created 381 to read: 382 465.1902 Preemption.—This chapter preempts to the state all 383 regulation of the licensure, activity, and operation of 384 pharmacies and pharmacists as defined in this chapter. A local 385 government or political subdivision of the state may not enact 386 or enforce an ordinance that imposes a levy, charge, or fee 387 upon, or that otherwise regulates, pharmacies and pharmacists as 388 defined in this chapter, except that this preemption does not 389 prohibit a local government or political subdivision from 390 enacting an ordinance regarding the following: 391 (1) Local business taxes adopted pursuant to chapter 205. 392 (2) Land use development regulations adopted pursuant to 393 chapter 163, which include regulation of any aspect of 394 development, including a subdivision, building construction, 395 sign regulation, and any other regulation concerning the 396 development of land, landscaping, or tree protection, and which 397 do not include restrictions on pain-management services, health 398 care services, or the prescribing of controlled substances. 399 Section 8. Paragraph (b) of subsection (2), subsection 400 (10), and paragraph (c) of subsection (11) of section 893.055, 401 Florida Statutes, are amended to read: 402 893.055 Prescription drug monitoring program.— 403 (2) 404 (b) The department, when the direct support organization405receives at least $20,000 in nonstate moneys or the state406receives at least $20,000 in federal grants for the prescription407drug monitoring program,shall adopt rules as necessary 408 concerning the reporting, accessing the database, evaluation, 409 management, development, implementation, operation, security, 410 and storage of information within the system, including rules 411 for when patient advisory reports are provided to pharmacies and 412 prescribers. The patient advisory report shall be provided in 413 accordance with s. 893.13(7)(a)8. The department shall work with 414 the professional health care licensure boards, such as the Board 415 of Medicine, the Board of Osteopathic Medicine, and the Board of 416 Pharmacy; other appropriate organizations, such as the Florida 417 Pharmacy Association, the Florida Medical Association, the 418 Florida Retail Federation, and the Florida Osteopathic Medical 419 Association, including those relating to pain management; and 420 the Attorney General, the Department of Law Enforcement, and the 421 Agency for Health Care Administration to develop rules 422 appropriate for the prescription drug monitoring program. 423 (10) All costs incurred by the department in administering 424 the prescription drug monitoring program shall be funded through 425 state funds, federal grants, or private funding applied for or 426 received by the state. The department may not commit funds for 427 the monitoring program without ensuring funding is available. 428The prescription drug monitoring program and the implementation429thereof are contingent upon receipt of the nonstate funding.The 430 department and state government shall cooperate with the direct 431 support organization established pursuant to subsection (11) in 432 seeking state funds, federal grant funds, other nonstate grant 433 funds, gifts, donations, or other private moneys for the 434 department ifso long asthe costs of doing so are not 435 considered material. Nonmaterial costs for this purpose include, 436 but are not limited to, the costs of mailing and personnel 437 assigned to research or apply for a grant. Notwithstanding the 438 exemptions to competitive-solicitation requirements under s. 439 287.057(3)(f), the department shall comply with the competitive 440 solicitation requirements under s. 287.057 for the procurement 441 of any goods or services required by this section.Funds442provided, directly or indirectly, by prescription drug443manufacturers may not be used to implement the program.444 (11) The department may establish a direct-support 445 organization that has a board consisting of at least five 446 members to provide assistance, funding, and promotional support 447 for the activities authorized for the prescription drug 448 monitoring program. 449 (c) The State Surgeon General shall appoint a board of 450 directors for the direct-support organization. Members of the 451 board shall serve at the pleasure of the State Surgeon General. 452 The State Surgeon General shall provide guidance to members of 453 the board to ensure that moneys received by the direct-support 454 organization are not received from inappropriate sources. 455 Inappropriate sources include, but are not limited to, donors, 456 grantors, persons,ororganizations, or pharmaceutical 457 companies, that may monetarily or substantively benefit from the 458 purchase of goods or services by the department in furtherance 459 of the prescription drug monitoring program. 460 Section 9. Section 893.0552, Florida Statutes, is created 461 to read: 462 893.0552 Preemption of regulation.— 463 (1) This section preempts to the state all regulation of 464 the licensure, activity, and operation of pain-management 465 clinics as defined in ss. 458.3265 and 459.0137 in the following 466 circumstances: 467 (a) The clinic is wholly owned and operated by a physician 468 who performs interventional pain procedures of the type 469 routinely billed using surgical codes, who has never been 470 suspended or revoked for prescribing a controlled substance in 471 Schedule II or Schedule III of s. 893.03 and drugs containing 472 Alprazolam in excessive or inappropriate quantities that are not 473 in the best interest of a patient, and who: 474 1. Has completed a fellowship in pain medicine which is 475 approved by the Accreditation Council for Graduate Medical 476 Education or the American Osteopathic Association; 477 2. Is board-certified in pain medicine by the American 478 Board of Pain Medicine, board-certified by the American Board of 479 Interventional Pain Physicians; or 480 3. Has a board certification or subcertification in pain 481 management or pain medicine by a specialty board approved by the 482 American Board of Medical Specialties or the American 483 Osteopathic Association. 484 (b) The clinic is wholly owned and operated by a physician 485 multispecialty practice if one or more board-eligible or board 486 certified medical specialists has one of the qualifications 487 specified in subparagraph (a)1., subparagraph (a)2., or 488 subparagraph (a)3., performs interventional pain procedures of 489 the type routinely billed using surgical codes, and has never 490 been suspended or revoked for prescribing a controlled substance 491 in Schedule II or Schedule III of s. 893.03 and drugs containing 492 Alprazolam in excessive or inappropriate quantities that are not 493 in the best interest of a patient. 494 (2) Notwithstanding subsection (1), the preemption does not 495 prohibit a local government or political subdivision from 496 enacting an ordinance regarding local business taxes adopted 497 pursuant to chapter 205 and land use development regulations 498 adopted pursuant to chapter 163. A pain-management clinic in 499 which the regulation of its licensure, activity, and operation 500 is preempted to the state pursuant to subsection (1) is a 501 permissible use in a land use or zoning category that permits 502 hospitals and other health care facilities or clinics as defined 503 in chapter 395 or s. 408.07. Upon the request of a local 504 government, a pain-management clinic must annually demonstrate 505 that it qualifies for preemption pursuant to subsection (1). 506 Section 10. Subsection (1) of section 409.9201, Florida 507 Statutes, is amended to read: 508 409.9201 Medicaid fraud.— 509 (1) As used in this section, the term: 510 (a) “Prescription drug” means any drug, including, but not 511 limited to, finished dosage forms or active ingredients that are 512 subject to, defined by, or described by s. 503(b) of the Federal 513 Food, Drug, and Cosmetic Act or by s. 465.003s.465.003(8), s. 514 499.003(46) or (53) or s. 499.007(13). 515 (b) “Value” means the amount billed to the Medicaid program 516 for the property dispensed or the market value of a legend drug 517 or goods or services at the time and place of the offense. If 518 the market value cannot be determined, the term means the 519 replacement cost of the legend drug or goods or services within 520 a reasonable time after the offense. 521 522 The value of individual items of the legend drugs or goods or 523 services involved in distinct transactions committed during a 524 single scheme or course of conduct, whether involving a single 525 person or several persons, may be aggregated when determining 526 the punishment for the offense. 527 Section 11. Paragraph (pp) of subsection (1) of section 528 458.331, Florida Statutes, is amended to read: 529 458.331 Grounds for disciplinary action; action by the 530 board and department.— 531 (1) The following acts constitute grounds for denial of a 532 license or disciplinary action, as specified in s. 456.072(2): 533 (pp) Applicable to a licensee who serves as the designated 534 physician of a pain-management clinic as defined in s. 458.3265 535 or s. 459.0137: 536 1. Registering a pain-management clinic through 537 misrepresentation or fraud; 538 2. Procuring, or attempting to procure, the registration of 539 a pain-management clinic for any other person by making or 540 causing to be made, any false representation; 541 3. Failing to comply with any requirement of chapter 499, 542 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the 543 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., 544 the Drug Abuse Prevention and Control Act; or chapter 893, the 545 Florida Comprehensive Drug Abuse Prevention and Control Act; 546 4. Being convicted or found guilty of, regardless of 547 adjudication to, a felony or any other crime involving moral 548 turpitude, fraud, dishonesty, or deceit in any jurisdiction of 549 the courts of this state, of any other state, or of the United 550 States; 551 5. Being convicted of, or disciplined by a regulatory 552 agency of the Federal Government or a regulatory agency of 553 another state for, any offense that would constitute a violation 554 of this chapter; 555 6. Being convicted of, or entering a plea of guilty or nolo 556 contendere to, regardless of adjudication, a crime in any 557 jurisdiction of the courts of this state, of any other state, or 558 of the United States which relates to the practice of, or the 559 ability to practice, a licensed health care profession; 560 7. Being convicted of, or entering a plea of guilty or nolo 561 contendere to, regardless of adjudication, a crime in any 562 jurisdiction of the courts of this state, of any other state, or 563 of the United States which relates to health care fraud; 564 8. Dispensing any medicinal drug based upon a communication 565 that purports to be a prescription as defined in s. 465.003s.566465.003(14)or s. 893.02 if the dispensing practitioner knows or 567 has reason to believe that the purported prescription is not 568 based upon a valid practitioner-patient relationship; or 569 9. Failing to timely notify the board of the date of his or 570 her termination from a pain-management clinic as required by s. 571 458.3265(2). 572 Section 12. Paragraph (rr) of subsection (1) of section 573 459.015, Florida Statutes, is amended to read: 574 459.015 Grounds for disciplinary action; action by the 575 board and department.— 576 (1) The following acts constitute grounds for denial of a 577 license or disciplinary action, as specified in s. 456.072(2): 578 (rr) Applicable to a licensee who serves as the designated 579 physician of a pain-management clinic as defined in s. 458.3265 580 or s. 459.0137: 581 1. Registering a pain-management clinic through 582 misrepresentation or fraud; 583 2. Procuring, or attempting to procure, the registration of 584 a pain-management clinic for any other person by making or 585 causing to be made, any false representation; 586 3. Failing to comply with any requirement of chapter 499, 587 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the 588 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., 589 the Drug Abuse Prevention and Control Act; or chapter 893, the 590 Florida Comprehensive Drug Abuse Prevention and Control Act; 591 4. Being convicted or found guilty of, regardless of 592 adjudication to, a felony or any other crime involving moral 593 turpitude, fraud, dishonesty, or deceit in any jurisdiction of 594 the courts of this state, of any other state, or of the United 595 States; 596 5. Being convicted of, or disciplined by a regulatory 597 agency of the Federal Government or a regulatory agency of 598 another state for, any offense that would constitute a violation 599 of this chapter; 600 6. Being convicted of, or entering a plea of guilty or nolo 601 contendere to, regardless of adjudication, a crime in any 602 jurisdiction of the courts of this state, of any other state, or 603 of the United States which relates to the practice of, or the 604 ability to practice, a licensed health care profession; 605 7. Being convicted of, or entering a plea of guilty or nolo 606 contendere to, regardless of adjudication, a crime in any 607 jurisdiction of the courts of this state, of any other state, or 608 of the United States which relates to health care fraud; 609 8. Dispensing any medicinal drug based upon a communication 610 that purports to be a prescription as defined in s. 465.003s.611465.003(14)or s. 893.02 if the dispensing practitioner knows or 612 has reason to believe that the purported prescription is not 613 based upon a valid practitioner-patient relationship; or 614 9. Failing to timely notify the board of the date of his or 615 her termination from a pain-management clinic as required by s. 616 459.0137(2). 617 Section 13. Subsection (1) of section 465.014, Florida 618 Statutes, is amended to read: 619 465.014 Pharmacy technician.— 620 (1) A person other than a licensed pharmacist or pharmacy 621 intern may not engage in the practice of the profession of 622 pharmacy, except that a licensed pharmacist may delegate to 623 pharmacy technicians who are registered pursuant to this section 624 those duties, tasks, and functions that do not fall within the 625 purview of s. 465.003s.465.003(13). All such delegated acts 626 shall be performed under the direct supervision of a licensed 627 pharmacist who shall be responsible for all such acts performed 628 by persons under his or her supervision. A pharmacy registered 629 technician, under the supervision of a pharmacist, may initiate 630 or receive communications with a practitioner or his or her 631 agent, on behalf of a patient, regarding refill authorization 632 requests. A licensed pharmacist may not supervise more than one 633 registered pharmacy technician unless otherwise permitted by the 634 guidelines adopted by the board. The board shall establish 635 guidelines to be followed by licensees or permittees in 636 determining the circumstances under which a licensed pharmacist 637 may supervise more than one but not more than three pharmacy 638 technicians. 639 Section 14. Paragraph (c) of subsection (2) of section 640 465.015, Florida Statutes, is amended to read: 641 465.015 Violations and penalties.— 642 (2) It is unlawful for any person: 643 (c) To sell or dispense drugs as defined in s. 465.003s.644465.003(8)without first being furnished with a prescription. 645 Section 15. Subsection (8) of section 465.0156, Florida 646 Statutes, is amended to read: 647 465.0156 Registration of nonresident pharmacies.— 648 (8) Notwithstanding s. 465.003s.465.003(10), for purposes 649 of this section, the registered pharmacy and the pharmacist 650 designated by the registered pharmacy as the prescription 651 department manager or the equivalent must be licensed in the 652 state of location in order to dispense into this state. 653 Section 16. Subsection (4) of section 465.0197, Florida 654 Statutes, is amended to read: 655 465.0197 Internet pharmacy permits.— 656 (4) Notwithstanding s. 465.003s.465.003(10), for purposes 657 of this section, the Internet pharmacy and the pharmacist 658 designated by the Internet pharmacy as the prescription 659 department manager or the equivalent must be licensed in the 660 state of location in order to dispense into this state. 661 Section 17. Section 465.1901, Florida Statutes, is amended 662 to read: 663 465.1901 Practice of orthotics and pedorthics.—The 664 provisions of chapter 468 relating to orthotics or pedorthics do 665 not apply to any licensed pharmacist or to any person acting 666 under the supervision of a licensed pharmacist. The practice of 667 orthotics or pedorthics by a pharmacist or any of the 668 pharmacist’s employees acting under the supervision of a 669 pharmacist shall be construed to be within the meaning of the 670 term “practice of the profession of pharmacy” as set forth in s. 671 465.003s.465.003(13), and shall be subject to regulation in 672 the same manner as any other pharmacy practice. The Board of 673 Pharmacy shall develop rules regarding the practice of orthotics 674 and pedorthics by a pharmacist. Any pharmacist or person under 675 the supervision of a pharmacist engaged in the practice of 676 orthotics or pedorthics is not precluded from continuing that 677 practice pending adoption of these rules. 678 Section 18. Subsection (43) of section 499.003, Florida 679 Statutes, is amended to read: 680 499.003 Definitions of terms used in this part.—As used in 681 this part, the term: 682 (43) “Prescription drug” means a prescription, medicinal, 683 or legend drug, including, but not limited to, finished dosage 684 forms or active pharmaceutical ingredients subject to, defined 685 by, or described by s. 503(b) of the Federal Food, Drug, and 686 Cosmetic Act or s. 465.003s.465.003(8), s. 499.007(13), or 687 subsection (11), subsection (46), or subsection (53), except 688 that an active pharmaceutical ingredient is a prescription drug 689 only if substantially all finished dosage forms in which it may 690 be lawfully dispensed or administered in this state are also 691 prescription drugs. 692 Section 19. Subsection (22) of section 893.02, Florida 693 Statutes, is amended to read: 694 893.02 Definitions.—The following words and phrases as used 695 in this chapter shall have the following meanings, unless the 696 context otherwise requires: 697 (22) “Prescription” means and includes an order for drugs 698 or medicinal supplies written, signed, or transmitted by word of 699 mouth, telephone, telegram, or other means of communication by a 700 duly licensed practitioner licensed by the laws of the state to 701 prescribe such drugs or medicinal supplies, issued in good faith 702 and in the course of professional practice, intended to be 703 filled, compounded, or dispensed by another person licensed by 704 the laws of the state to do so, and meeting the requirements of 705 s. 893.04. The term also includes an order for drugs or 706 medicinal supplies so transmitted or written by a physician, 707 dentist, veterinarian, or other practitioner licensed to 708 practice in a state other than Florida, but only if the 709 pharmacist called upon to fill such an order determines, in the 710 exercise of his or her professional judgment, that the order was 711 issued pursuant to a valid patient-physician relationship, that 712 it is authentic, and that the drugs or medicinal supplies so 713 ordered are considered necessary for the continuation of 714 treatment of a chronic or recurrent illness. However, if the 715 physician writing the prescription is not known to the 716 pharmacist, the pharmacist shall obtain proof to a reasonable 717 certainty of the validity of said prescription. A prescription 718 order for a controlled substance shall not be issued on the same 719 prescription blank with another prescription order for a 720 controlled substance which is named or described in a different 721 schedule, nor shall any prescription order for a controlled 722 substance be issued on the same prescription blank as a 723 prescription order for a medicinal drug, as defined in s. 724 465.003s.465.003(8), which does not fall within the definition 725 of a controlled substance as defined in this act. 726 Section 20. This act shall take effect July 1, 2013.