Bill Text: FL S1192 | 2013 | Regular Session | Engrossed
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-Engrossed.html
CS for CS for CS for SB 1192 First Engrossed 20131192e1 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 Board of Medicine and the 9 Board of Osteopathic Medicine to adopt a penalty for 10 failure to consult the database; exempting nursing 11 home residents and certain physicians from 12 requirements regarding prescriptions of controlled 13 substances; amending s. 465.003, F.S.; defining a 14 term; conforming a cross-reference; creating s. 15 465.0065, F.S.; providing notice requirements for 16 inspection of a pharmacy; amending s. 465.016, F.S.; 17 providing additional grounds for disciplinary action; 18 conforming a cross-reference; amending s. 465.022, 19 F.S.; conforming a cross-reference; requiring a 20 pharmacy permittee to commence operations within 180 21 days after permit issuance or show good cause why 22 operations were not commenced; requiring the Board of 23 Pharmacy to establish rules; requiring a pharmacy 24 permittee to be supervised by a prescription 25 department manager or consultant pharmacist of record; 26 amending s. 465.023, F.S.; providing additional 27 grounds for disciplinary action; conforming a cross 28 reference; creating s. 465.1902, F.S.; providing that 29 the regulation of pharmacies and pharmacists is 30 preempted to the state; providing that a local 31 ordinance, rule, or regulation may not be enacted or 32 remain in effect which regulates or attempts to 33 regulate pharmacies or pharmacists in subject matters 34 regulated under ch. 465, F.S.; amending s. 893.055, 35 F.S.; deleting obsolete provisions; requiring a 36 designated agent under the supervision of a health 37 care practitioner to have access to information in the 38 prescription drug monitoring program’s database; 39 deleting a provision that prohibits funds from 40 prescription drug manufacturers to be used to 41 implement the prescription drug monitoring program; 42 authorizing the prescription drug monitoring program 43 to be funded by state funds; revising the sources of 44 money which are inappropriate for the direct-support 45 organization of the prescription drug monitoring 46 program to receive; amending s. 893.0551, F.S.; 47 requiring the Department of Health to disclose certain 48 confidential and exempt information to a designated 49 agent of a health care practitioner or pharmacist 50 under certain circumstances; creating s. 893.0552, 51 F.S.; providing that regulation of the licensure, 52 standards of practice, and operation of pain 53 management clinics is preempted to the state under 54 certain circumstances; authorizing a local government 55 or political subdivision to enact certain ordinances; 56 amending ss. 409.9201, 458.331, 459.015, 465.014, 57 465.015, 465.0156, 465.0197, 465.1901, 499.003, and 58 893.02, F.S.; conforming cross-references; providing 59 an effective date. 60 61 Be It Enacted by the Legislature of the State of Florida: 62 63 Section 1. Section 456.44, Florida Statutes, is amended to 64 read: 65 456.44 Controlled substance prescribing.— 66 (1) DEFINITIONS.— 67 (a) “Addiction medicine specialist” means a board-certified 68 psychiatrist with a subspecialty certification in addiction 69 medicine or who is eligible for such subspecialty certification 70 in addiction medicine, an addiction medicine physician certified 71 or eligible for certification by the American Society of 72 Addiction Medicine, or an osteopathic physician who holds a 73 certificate of added qualification in Addiction Medicine through 74 the American Osteopathic Association. 75 (b) “Adverse incident” means any incident set forth in s. 76 458.351(4)(a)-(e) or s. 459.026(4)(a)-(e). 77 (c) “Board-certified pain management physician” means a 78 physician who possesses board certification in pain medicine by 79 the American Board of Pain Medicine, board certification by the 80 American Board of Interventional Pain Physicians, or board 81 certification or subcertification in pain management or pain 82 medicine by a specialty board recognized by the American 83 Association of Physician Specialists or the American Board of 84 Medical Specialties or an osteopathic physician who holds a 85 certificate in Pain Management by the American Osteopathic 86 Association. 87 (d) “Board eligible” means successful completion of an 88 anesthesia, physical medicine and rehabilitation, rheumatology, 89 or neurology residency program approved by the Accreditation 90 Council for Graduate Medical Education or the American 91 Osteopathic Association for a period of 6 years from successful 92 completion of such residency program. 93 (e) “Chronic nonmalignant pain” means pain unrelated to 94 cancer which persists beyond the usual course of disease or the 95 injury that is the cause of the pain or more than 90 days after 96 surgery. 97 (f) “Mental health addiction facility” means a facility 98 licensed under chapter 394 or chapter 397. 99 (2) REGISTRATION.—Effective January 1, 2012,A physician 100 licensed under chapter 458, chapter 459, chapter 461, or chapter 101 466 who prescribes more than a 30-day supply of any controlled 102 substance, listed in Schedule II, Schedule III, or Schedule IV 103 as defined in s. 893.03, over a 6-month period to any one 104 patient for the treatment of chronic nonmalignant pain, must: 105 (a) Designate himself or herself as a controlled substance 106 prescribing practitioner on the physician’s practitioner 107 profile. 108 (b) Comply with the requirements of this section and 109 applicable board rules. 110 (3) STANDARDS OF PRACTICE.—The standards of practice in 111 this section do not supersede the level of care, skill, and 112 treatment recognized in general law related to health care 113 licensure. 114 (a) A complete medical history and a physical examination 115 must be conducted before beginning any treatment and must be 116 documented in the medical record. The exact components of the 117 physical examination shall be left to the judgment of the 118 clinician who is expected to perform a physical examination 119 proportionate to the diagnosis that justifies a treatment. The 120 medical record must, at a minimum, document the nature and 121 intensity of the pain, current and past treatments for pain, 122 underlying or coexisting diseases or conditions, the effect of 123 the pain on physical and psychological function, a review of 124 previous medical records, previous diagnostic studies, and 125 history of alcohol and substance abuse. The medical record shall 126 also document the presence of one or more recognized medical 127 indications for the use of a controlled substance. Each 128 registrant must develop a written plan for assessing each 129 patient’s risk of aberrant drug-related behavior, which may 130 include patient drug testing. Registrants must assess each 131 patient’s risk for aberrant drug-related behavior and monitor 132 that risk on an ongoing basis in accordance with the plan. 133 (b) Before or during a new patient’s visit for services for 134 the treatment of pain at a pain-management clinic registered 135 under s. 458.3265 or s. 459.0137, a physician shall consult the 136 prescription drug monitoring program database provided under s. 137 893.055(2)(a) before prescribing a controlled substance listed 138 in Schedule II or Schedule III in s. 893.03. The physician may 139 designate an agent under his or her supervision to consult the 140 database. The Board of Medicine under chapter 458 and the Board 141 of Osteopathic Medicine under chapter 459 shall adopt rules to 142 establish a penalty for a physician who does not comply with 143 this subsection. 144 (c)(b)Each registrant must develop a written 145 individualized treatment plan for each patient. The treatment 146 plan shall state objectives that will be used to determine 147 treatment success, such as pain relief and improved physical and 148 psychosocial function, and shall indicate if any further 149 diagnostic evaluations or other treatments are planned. After 150 treatment begins, the physician shall adjust drug therapy to the 151 individual medical needs of each patient. Other treatment 152 modalities, including a rehabilitation program, shall be 153 considered depending on the etiology of the pain and the extent 154 to which the pain is associated with physical and psychosocial 155 impairment. The interdisciplinary nature of the treatment plan 156 shall be documented. 157 (d)(c)The physician shall discuss the risks and benefits 158 of the use of controlled substances, including the risks of 159 abuse and addiction, as well as physical dependence and its 160 consequences, with the patient, persons designated by the 161 patient, or the patient’s surrogate or guardian if the patient 162 is incompetent. The physician shall use a written controlled 163 substance agreement between the physician and the patient 164 outlining the patient’s responsibilities, including, but not 165 limited to: 166 1. Number and frequency of controlled substance 167 prescriptions and refills. 168 2. Patient compliance and reasons for which drug therapy 169 may be discontinued, such as a violation of the agreement. 170 3. An agreement that controlled substances for the 171 treatment of chronic nonmalignant pain shall be prescribed by a 172 single treating physician unless otherwise authorized by the 173 treating physician and documented in the medical record. 174 (e)(d)The patient shall be seen by the physician at 175 regular intervals, not to exceed 3 months, to assess the 176 efficacy of treatment, ensure that controlled substance therapy 177 remains indicated, evaluate the patient’s progress toward 178 treatment objectives, consider adverse drug effects, and review 179 the etiology of the pain. Continuation or modification of 180 therapy shall depend on the physician’s evaluation of the 181 patient’s progress. If treatment goals are not being achieved, 182 despite medication adjustments, the physician shall reevaluate 183 the appropriateness of continued treatment. The physician shall 184 monitor patient compliance in medication usage, related 185 treatment plans, controlled substance agreements, and 186 indications of substance abuse or diversion at a minimum of 3 187 month intervals. 188 (f)(e)The physician shall refer the patient as necessary 189 for additional evaluation and treatment in order to achieve 190 treatment objectives. Special attention shall be given to those 191 patients who are at risk for misusing their medications and 192 those whose living arrangements pose a risk for medication 193 misuse or diversion. The management of pain in patients with a 194 history of substance abuse or with a comorbid psychiatric 195 disorder requires extra care, monitoring, and documentation and 196 requires consultation with or referral to an addiction medicine 197 specialist or psychiatrist. 198 (g)(f)A physician registered under this section must 199 maintain accurate, current, and complete records that are 200 accessible and readily available for review and comply with the 201 requirements of this section, the applicable practice act, and 202 applicable board rules. The medical records must include, but 203 are not limited to: 204 1. The complete medical history and a physical examination, 205 including history of drug abuse or dependence. 206 2. Diagnostic, therapeutic, and laboratory results. 207 3. Evaluations and consultations. 208 4. Treatment objectives. 209 5. Discussion of risks and benefits. 210 6. Treatments. 211 7. Medications, including date, type, dosage, and quantity 212 prescribed. 213 8. Instructions and agreements. 214 9. Periodic reviews. 215 10. Results of any drug testing. 216 11. A photocopy of the patient’s government-issued photo 217 identification. 218 12. If a written prescription for a controlled substance is 219 given to the patient, a duplicate of the prescription. 220 13. The physician’s full name presented in a legible 221 manner. 222 (h)(g)Patients with signs or symptoms of substance abuse 223 shall be immediately referred to a board-certified pain 224 management physician, an addiction medicine specialist, or a 225 mental health addiction facility as it pertains to drug abuse or 226 addiction unless the physician is board-certified or board 227 eligible in pain management. Throughout the period of time 228 before receiving the consultant’s report, a prescribing 229 physician shall clearly and completely document medical 230 justification for continued treatment with controlled substances 231 and those steps taken to ensure medically appropriate use of 232 controlled substances by the patient. Upon receipt of the 233 consultant’s written report, the prescribing physician shall 234 incorporate the consultant’s recommendations for continuing, 235 modifying, or discontinuing controlled substance therapy. The 236 resulting changes in treatment shall be specifically documented 237 in the patient’s medical record. Evidence or behavioral 238 indications of diversion shall be followed by discontinuation of 239 controlled substance therapy, and the patient shall be 240 discharged, and all results of testing and actions taken by the 241 physician shall be documented in the patient’s medical record. 242 243 This sectionsubsectiondoes not apply to a board-eligible or 244 board-certified anesthesiologist, physiatrist, rheumatologist, 245 or neurologist, or to a board-certified physician who has 246 surgical privileges at a hospital or ambulatory surgery center 247 and primarily provides surgical services. This section 248subsectiondoes not apply to a board-eligible or board-certified 249 medical specialist who has also completed a fellowship in pain 250 medicine approved by the Accreditation Council for Graduate 251 Medical Education or the American Osteopathic Association, or 252 who is board eligible or board certified in pain medicine by the 253 American Board of Pain Medicine or a board approved by the 254 American Board of Medical Specialties or the American 255 Osteopathic Association and performs interventional pain 256 procedures of the type routinely billed using surgical codes. 257 This sectionsubsectiondoes not apply to a physician who 258 prescribes medically necessary controlled substances for a 259 patient during an inpatient stay in a hospital licensed under 260 chapter 395 or to a resident in a facility licensed under part 261 II of chapter 400. This section does not apply to a physician 262 licensed under chapter 458 or chapter 459 who writes fewer than 263 50 prescriptions for a controlled substance for all of his or 264 her patients during a 1-year period. 265 Section 2. Present subsections (1) through (17) of section 266 465.003, Florida Statutes, are renumbered as subsections (2) 267 through (18), respectively, paragraph (a) of present subsection 268 (11) of that section is amended, and a new subsection (1) is 269 added to that section, to read: 270 465.003 Definitions.—As used in this chapter, the term: 271 (1) “Abandoned” means the status of a pharmacy permit of a 272 person or entity that was issued the permit but fails to 273 commence pharmacy operations within 180 days after issuance of 274 the permit without good cause or fails to follow pharmacy 275 closure requirements as set by the board. 276 (12)(11)(a) “Pharmacy” includes a community pharmacy, an 277 institutional pharmacy, a nuclear pharmacy, a special pharmacy, 278 and an Internet pharmacy. 279 1. The term “community pharmacy” includes every location 280 where medicinal drugs are compounded, dispensed, stored, or sold 281 or where prescriptions are filled or dispensed on an outpatient 282 basis. 283 2. The term “institutional pharmacy” includes every 284 location in a hospital, clinic, nursing home, dispensary, 285 sanitarium, extended care facility, or other facility, 286 hereinafter referred to as “health care institutions,” where 287 medicinal drugs are compounded, dispensed, stored, or sold. 288 3. The term “nuclear pharmacy” includes every location 289 where radioactive drugs and chemicals within the classification 290 of medicinal drugs are compounded, dispensed, stored, or sold. 291 The term “nuclear pharmacy” does not include hospitals licensed 292 under chapter 395 or the nuclear medicine facilities of such 293 hospitals. 294 4. The term “special pharmacy” includes every location 295 where medicinal drugs are compounded, dispensed, stored, or sold 296 if such locations are not otherwise defined in this subsection. 297 5. The term “Internet pharmacy” includes locations not 298 otherwise licensed or issued a permit under this chapter, within 299 or outside this state, which use the Internet to communicate 300 with or obtain information from consumers in this state and use 301 such communication or information to fill or refill 302 prescriptions or to dispense, distribute, or otherwise engage in 303 the practice of pharmacy in this state. Any act described in 304 this definition constitutes the practice of pharmacy as defined 305 in subsection (14)(13). 306 Section 3. Section 465.0065, Florida Statutes, is created 307 to read: 308 465.0065 Notices; form and service.—Each notice served by 309 the department pursuant to this chapter must be in writing and 310 must be delivered personally by an agent of the department or by 311 certified mail to the pharmacy permittee or licensee. If the 312 pharmacy permittee or licensee refuses to accept service or 313 evades service or if the agent is otherwise unable to carry out 314 service after due diligence, the department may post the notice 315 in a conspicuous place at the pharmacy or at the home or 316 business address for the licensee. 317 Section 4. Paragraphs (e) and (s) of subsection (1) of 318 section 465.016, Florida Statutes, are amended, and paragraph 319 (u) is added to that subsection, to read: 320 465.016 Disciplinary actions.— 321 (1) The following acts constitute grounds for denial of a 322 license or disciplinary action, as specified in s. 456.072(2): 323 (e) Violating chapter 499; 21 U.S.C. ss. 301-392, known as 324 the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et 325 seq., known as the Comprehensive Drug Abuse Prevention and 326 Control Act; or chapter 893 or rules adopted thereunder. 327 (s) Dispensing any medicinal drug based upon a 328 communication that purports to be a prescription as defined by 329 s. 465.003s.465.003(14)or s. 893.02 when the pharmacist knows 330 or has reason to believe that the purported prescription is not 331 based upon a valid practitioner-patient relationship. 332 (u) Misappropriating drugs, supplies, or equipment from a 333 pharmacy permittee. 334 Section 5. Paragraph (j) of subsection (5) of section 335 465.022, Florida Statutes, is amended, present subsections (10) 336 through (14) are renumbered as subsections (11) through (15), 337 respectively, present subsection (10) of that section is 338 amended, and a new subsection (10) is added to that section, to 339 read: 340 465.022 Pharmacies; general requirements; fees.— 341 (5) The department or board shall deny an application for a 342 pharmacy permit if the applicant or an affiliated person, 343 partner, officer, director, or prescription department manager 344 or consultant pharmacist of record of the applicant: 345 (j) Has dispensed any medicinal drug based upon a 346 communication that purports to be a prescription as defined by 347 s. 465.003s.465.003(14)or s. 893.02 when the pharmacist knows 348 or has reason to believe that the purported prescription is not 349 based upon a valid practitioner-patient relationship that 350 includes a documented patient evaluation, including history and 351 a physical examination adequate to establish the diagnosis for 352 which any drug is prescribed and any other requirement 353 established by board rule under chapter 458, chapter 459, 354 chapter 461, chapter 463, chapter 464, or chapter 466. 355 356 For felonies in which the defendant entered a plea of guilty or 357 nolo contendere in an agreement with the court to enter a 358 pretrial intervention or drug diversion program, the department 359 shall deny the application if upon final resolution of the case 360 the licensee has failed to successfully complete the program. 361 (10) The permittee shall commence pharmacy operations 362 within 180 days after issuance of the permit, or show good cause 363 to the department why pharmacy operations were not commenced. 364 Commencement of pharmacy operations includes, but is not limited 365 to, acts within the scope of the practice of pharmacy, ordering 366 or receiving drugs, and other similar activities. The board 367 shall establish rules regarding commencement of pharmacy 368 operations. 369 (11)(10)A pharmacy permittee shall be supervised by a 370 prescription department manager or consultant pharmacist of 371 record at all times. A permittee must notify the department, on 372 a form approved by the board, within 10 days after any change in 373 prescription department manager or consultant pharmacist of 374 record. 375 Section 6. Subsection (1) of section 465.023, Florida 376 Statutes, is amended to read: 377 465.023 Pharmacy permittee; disciplinary action.— 378 (1) The department or the board may revoke or suspend the 379 permit of any pharmacy permittee, and may fine, place on 380 probation, or otherwise discipline any pharmacy permittee if the 381 permittee, or any affiliated person, partner, officer, director, 382 or agent of the permittee, including a person fingerprinted 383 under s. 465.022(3), has: 384 (a) Obtained a permit by misrepresentation or fraud or 385 through an error of the department or the board; 386 (b) Attempted to procure, or has procured, a permit for any 387 other person by making, or causing to be made, any false 388 representation; 389 (c) Violated any of the requirements of this chapter or any 390 of the rules of the Board of Pharmacy; of chapter 499, known as 391 the “Florida Drug and Cosmetic Act”; of 21 U.S.C. ss. 301-392, 392 known as the “Federal Food, Drug, and Cosmetic Act”; of 21 393 U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse 394 Prevention and Control Act; or of chapter 893 or rules adopted 395 thereunder; 396 (d) Been convicted or found guilty, regardless of 397 adjudication, of a felony or any other crime involving moral 398 turpitude in any of the courts of this state, of any other 399 state, or of the United States; 400 (e) Been convicted or disciplined by a regulatory agency of 401 the Federal Government or a regulatory agency of another state 402 for any offense that would constitute a violation of this 403 chapter; 404 (f) Been convicted of, or entered a plea of guilty or nolo 405 contendere to, regardless of adjudication, a crime in any 406 jurisdiction which relates to the practice of, or the ability to 407 practice, the profession of pharmacy; 408 (g) Been convicted of, or entered a plea of guilty or nolo 409 contendere to, regardless of adjudication, a crime in any 410 jurisdiction which relates to health care fraud; or 411 (h) Dispensed any medicinal drug based upon a communication 412 that purports to be a prescription as defined by s. 465.003s.413465.003(14)or s. 893.02 when the pharmacist knows or has reason 414 to believe that the purported prescription is not based upon a 415 valid practitioner-patient relationship that includes a 416 documented patient evaluation, including history and a physical 417 examination adequate to establish the diagnosis for which any 418 drug is prescribed and any other requirement established by 419 board rule under chapter 458, chapter 459, chapter 461, chapter 420 463, chapter 464, or chapter 466. 421 Section 7. Section 465.1902, Florida Statutes, is created 422 to read: 423 465.1902 Preemption.—The regulation of pharmacies and 424 pharmacists is expressly preempted to the state. No local 425 ordinance, rule, or regulation shall be enacted or remain in 426 effect which regulates or attempts to regulate pharmacies or 427 pharmacists in subject matters regulated under this chapter, 428 including, but not limited to, licensure, discipline, pharmacy 429 permitting, and the dispensing of controlled substances. 430 Section 8. Paragraph (b) of subsection (2), paragraph (b) 431 of subsection (7), subsection (10), and paragraph (c) of 432 subsection (11) of section 893.055, Florida Statutes, are 433 amended to read: 434 893.055 Prescription drug monitoring program.— 435 (2) 436 (b) The department, when the direct support organization437receives at least $20,000 in nonstate moneys or the state438receives at least $20,000 in federal grants for the prescription439drug monitoring program,shall adopt rules as necessary 440 concerning the reporting, accessing the database, evaluation, 441 management, development, implementation, operation, security, 442 and storage of information within the system, including rules 443 for when patient advisory reports are provided to pharmacies and 444 prescribers. The patient advisory report shall be provided in 445 accordance with s. 893.13(7)(a)8. The department shall work with 446 the professional health care licensure boards, such as the Board 447 of Medicine, the Board of Osteopathic Medicine, and the Board of 448 Pharmacy; other appropriate organizations, such as the Florida 449 Pharmacy Association, the Florida Medical Association, the 450 Florida Retail Federation, and the Florida Osteopathic Medical 451 Association, including those relating to pain management; and 452 the Attorney General, the Department of Law Enforcement, and the 453 Agency for Health Care Administration to develop rules 454 appropriate for the prescription drug monitoring program. 455 (7) 456 (b) A pharmacy, prescriber, designated agent under the 457 supervision of a health care practitioner, or dispenser shall 458 have access to information in the prescription drug monitoring 459 program’s database which relates to a patient of that pharmacy, 460 prescriber, or dispenser in a manner established by the 461 department as needed for the purpose of reviewing the patient’s 462 controlled substance prescription history. Other access to the 463 program’s database shall be limited to the program’s manager and 464 to the designated program and support staff, who may act only at 465 the direction of the program manager or, in the absence of the 466 program manager, as authorized. Access by the program manager or 467 such designated staff is for prescription drug program 468 management only or for management of the program’s database and 469 its system in support of the requirements of this section and in 470 furtherance of the prescription drug monitoring program. 471 Confidential and exempt information in the database shall be 472 released only as provided in paragraph (c) and s. 893.0551. The 473 program manager, designated program and support staff who act at 474 the direction of or in the absence of the program manager, and 475 any individual who has similar access regarding the management 476 of the database from the prescription drug monitoring program 477 shall submit fingerprints to the department for background 478 screening. The department shall follow the procedure established 479 by the Department of Law Enforcement to request a statewide 480 criminal history record check and to request that the Department 481 of Law Enforcement forward the fingerprints to the Federal 482 Bureau of Investigation for a national criminal history record 483 check. 484 (10) All costs incurred by the department in administering 485 the prescription drug monitoring program shall be funded through 486 state funds, federal grants, or private funding applied for or 487 received by the state. The department may not commit funds for 488 the monitoring program without ensuring funding is available. 489The prescription drug monitoring program and the implementation490thereof are contingent upon receipt of the nonstate funding.The 491 department and state government shall cooperate with the direct 492 support organization established pursuant to subsection (11) in 493 seeking state funds, federal grant funds, other nonstate grant 494 funds, gifts, donations, or other private moneys for the 495 department ifso long asthe costs of doing so are not 496 considered material. Nonmaterial costs for this purpose include, 497 but are not limited to, the costs of mailing and personnel 498 assigned to research or apply for a grant. Notwithstanding the 499 exemptions to competitive-solicitation requirements under s. 500 287.057(3)(f), the department shall comply with the competitive 501 solicitation requirements under s. 287.057 for the procurement 502 of any goods or services required by this section.Funds503provided, directly or indirectly, by prescription drug504manufacturers may not be used to implement the program.505 (11) The department may establish a direct-support 506 organization that has a board consisting of at least five 507 members to provide assistance, funding, and promotional support 508 for the activities authorized for the prescription drug 509 monitoring program. 510 (c) The State Surgeon General shall appoint a board of 511 directors for the direct-support organization. Members of the 512 board shall serve at the pleasure of the State Surgeon General. 513 The State Surgeon General shall provide guidance to members of 514 the board to ensure that moneys received by the direct-support 515 organization are not received from inappropriate sources. 516 Inappropriate sources include, but are not limited to, donors, 517 grantors, persons,ororganizations, or pharmaceutical 518 companies, that may monetarily or substantively benefit from the 519 purchase of goods or services by the department in furtherance 520 of the prescription drug monitoring program. 521 Section 9. Paragraphs (d) and (e) of subsection (3) of 522 section 893.0551, Florida Statutes, are amended to read: 523 893.0551 Public records exemption for the prescription drug 524 monitoring program.— 525 (3) The department shall disclose such confidential and 526 exempt information to the following entities after using a 527 verification process to ensure the legitimacy of that person’s 528 or entity’s request for the information: 529 (d) A health care practitioner or a designated agent under 530 his or her supervision who certifies that the information is 531 necessary to provide medical treatment to a current patient in 532 accordance with ss. 893.05 and 893.055. 533 (e) A pharmacist or a designated agent under his or her 534 supervision who certifies that the requested information will be 535 used to dispense controlled substances to a current patient in 536 accordance with ss. 893.04 and 893.055. 537 Section 10. Section 893.0552, Florida Statutes, is created 538 to read: 539 893.0552 Preemption of regulation.— 540 (1) This section preempts to the state all regulation of 541 the licensure, standards of practice, and operation of pain 542 management clinics as defined in ss. 458.3265 and 459.0137 in 543 the following circumstances: 544 (a) The clinic is wholly owned and operated by a physician 545 who performs interventional pain procedures of the type 546 routinely billed using surgical codes, who has never been 547 suspended or revoked for prescribing a controlled substance in 548 Schedule II or Schedule III of s. 893.03 and drugs containing 549 Alprazolam in excessive or inappropriate quantities that are not 550 in the best interest of a patient, and who: 551 1. Has completed a fellowship in pain medicine which is 552 approved by the Accreditation Council for Graduate Medical 553 Education or the American Osteopathic Association; 554 2. Is board-certified in pain medicine by the American 555 Board of Pain Medicine, board-certified by the American Board of 556 Interventional Pain Physicians; or 557 3. Has a board certification or subcertification in pain 558 management or pain medicine by a specialty board approved by the 559 American Board of Medical Specialties or the American 560 Osteopathic Association. 561 (b) The clinic is wholly owned and operated by a physician 562 multispecialty practice if one or more board-eligible or board 563 certified medical specialists has one of the qualifications 564 specified in subparagraph (a)1., subparagraph (a)2., or 565 subparagraph (a)3., performs interventional pain procedures of 566 the type routinely billed using surgical codes, and has never 567 been suspended or revoked for prescribing a controlled substance 568 in Schedule II or Schedule III of s. 893.03 and drugs containing 569 Alprazolam in excessive or inappropriate quantities that are not 570 in the best interest of a patient. 571 (2) Notwithstanding subsection (1), the preemption does not 572 prohibit a local government or political subdivision from 573 enacting an ordinance regarding local business taxes adopted 574 pursuant to chapter 205, any other local levy, charge, or fee 575 applied to businesses currently authorized by general law or the 576 Florida Constitution, and land use development regulations 577 adopted pursuant to chapter 163. A pain-management clinic in 578 which the regulation of its licensure, standards of practice, 579 and operation is preempted to the state pursuant to subsection 580 (1) is a permissible use in a land use or zoning category that 581 permits hospitals and other health care facilities or clinics as 582 defined in chapter 395 or s. 408.07. Upon the request of a local 583 government, a pain-management clinic must annually demonstrate 584 that it qualifies for preemption pursuant to subsection (1). 585 Section 11. Subsection (1) of section 409.9201, Florida 586 Statutes, is amended to read: 587 409.9201 Medicaid fraud.— 588 (1) As used in this section, the term: 589 (a) “Prescription drug” means any drug, including, but not 590 limited to, finished dosage forms or active ingredients that are 591 subject to, defined by, or described by s. 503(b) of the Federal 592 Food, Drug, and Cosmetic Act or by s. 465.003s.465.003(8), s. 593 499.003(46) or (53) or s. 499.007(13). 594 (b) “Value” means the amount billed to the Medicaid program 595 for the property dispensed or the market value of a legend drug 596 or goods or services at the time and place of the offense. If 597 the market value cannot be determined, the term means the 598 replacement cost of the legend drug or goods or services within 599 a reasonable time after the offense. 600 601 The value of individual items of the legend drugs or goods or 602 services involved in distinct transactions committed during a 603 single scheme or course of conduct, whether involving a single 604 person or several persons, may be aggregated when determining 605 the punishment for the offense. 606 Section 12. Paragraph (pp) of subsection (1) of section 607 458.331, Florida Statutes, is amended to read: 608 458.331 Grounds for disciplinary action; action by the 609 board and department.— 610 (1) The following acts constitute grounds for denial of a 611 license or disciplinary action, as specified in s. 456.072(2): 612 (pp) Applicable to a licensee who serves as the designated 613 physician of a pain-management clinic as defined in s. 458.3265 614 or s. 459.0137: 615 1. Registering a pain-management clinic through 616 misrepresentation or fraud; 617 2. Procuring, or attempting to procure, the registration of 618 a pain-management clinic for any other person by making or 619 causing to be made, any false representation; 620 3. Failing to comply with any requirement of chapter 499, 621 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the 622 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., 623 the Drug Abuse Prevention and Control Act; or chapter 893, the 624 Florida Comprehensive Drug Abuse Prevention and Control Act; 625 4. Being convicted or found guilty of, regardless of 626 adjudication to, a felony or any other crime involving moral 627 turpitude, fraud, dishonesty, or deceit in any jurisdiction of 628 the courts of this state, of any other state, or of the United 629 States; 630 5. Being convicted of, or disciplined by a regulatory 631 agency of the Federal Government or a regulatory agency of 632 another state for, any offense that would constitute a violation 633 of this chapter; 634 6. Being convicted of, or entering a plea of guilty or nolo 635 contendere to, regardless of adjudication, a crime in any 636 jurisdiction of the courts of this state, of any other state, or 637 of the United States which relates to the practice of, or the 638 ability to practice, a licensed health care profession; 639 7. Being convicted of, or entering a plea of guilty or nolo 640 contendere to, regardless of adjudication, a crime in any 641 jurisdiction of the courts of this state, of any other state, or 642 of the United States which relates to health care fraud; 643 8. Dispensing any medicinal drug based upon a communication 644 that purports to be a prescription as defined in s. 465.003s.645465.003(14)or s. 893.02 if the dispensing practitioner knows or 646 has reason to believe that the purported prescription is not 647 based upon a valid practitioner-patient relationship; or 648 9. Failing to timely notify the board of the date of his or 649 her termination from a pain-management clinic as required by s. 650 458.3265(2). 651 Section 13. Paragraph (rr) of subsection (1) of section 652 459.015, Florida Statutes, is amended to read: 653 459.015 Grounds for disciplinary action; action by the 654 board and department.— 655 (1) The following acts constitute grounds for denial of a 656 license or disciplinary action, as specified in s. 456.072(2): 657 (rr) Applicable to a licensee who serves as the designated 658 physician of a pain-management clinic as defined in s. 458.3265 659 or s. 459.0137: 660 1. Registering a pain-management clinic through 661 misrepresentation or fraud; 662 2. Procuring, or attempting to procure, the registration of 663 a pain-management clinic for any other person by making or 664 causing to be made, any false representation; 665 3. Failing to comply with any requirement of chapter 499, 666 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the 667 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., 668 the Drug Abuse Prevention and Control Act; or chapter 893, the 669 Florida Comprehensive Drug Abuse Prevention and Control Act; 670 4. Being convicted or found guilty of, regardless of 671 adjudication to, a felony or any other crime involving moral 672 turpitude, fraud, dishonesty, or deceit in any jurisdiction of 673 the courts of this state, of any other state, or of the United 674 States; 675 5. Being convicted of, or disciplined by a regulatory 676 agency of the Federal Government or a regulatory agency of 677 another state for, any offense that would constitute a violation 678 of this chapter; 679 6. Being convicted of, or entering a plea of guilty or nolo 680 contendere to, regardless of adjudication, a crime in any 681 jurisdiction of the courts of this state, of any other state, or 682 of the United States which relates to the practice of, or the 683 ability to practice, a licensed health care profession; 684 7. Being convicted of, or entering a plea of guilty or nolo 685 contendere to, regardless of adjudication, a crime in any 686 jurisdiction of the courts of this state, of any other state, or 687 of the United States which relates to health care fraud; 688 8. Dispensing any medicinal drug based upon a communication 689 that purports to be a prescription as defined in s. 465.003s.690465.003(14)or s. 893.02 if the dispensing practitioner knows or 691 has reason to believe that the purported prescription is not 692 based upon a valid practitioner-patient relationship; or 693 9. Failing to timely notify the board of the date of his or 694 her termination from a pain-management clinic as required by s. 695 459.0137(2). 696 Section 14. Subsection (1) of section 465.014, Florida 697 Statutes, is amended to read: 698 465.014 Pharmacy technician.— 699 (1) A person other than a licensed pharmacist or pharmacy 700 intern may not engage in the practice of the profession of 701 pharmacy, except that a licensed pharmacist may delegate to 702 pharmacy technicians who are registered pursuant to this section 703 those duties, tasks, and functions that do not fall within the 704 purview of s. 465.003s.465.003(13). All such delegated acts 705 shall be performed under the direct supervision of a licensed 706 pharmacist who shall be responsible for all such acts performed 707 by persons under his or her supervision. A pharmacy registered 708 technician, under the supervision of a pharmacist, may initiate 709 or receive communications with a practitioner or his or her 710 agent, on behalf of a patient, regarding refill authorization 711 requests. A licensed pharmacist may not supervise more than one 712 registered pharmacy technician unless otherwise permitted by the 713 guidelines adopted by the board. The board shall establish 714 guidelines to be followed by licensees or permittees in 715 determining the circumstances under which a licensed pharmacist 716 may supervise more than one but not more than three pharmacy 717 technicians. 718 Section 15. Paragraph (c) of subsection (2) of section 719 465.015, Florida Statutes, is amended to read: 720 465.015 Violations and penalties.— 721 (2) It is unlawful for any person: 722 (c) To sell or dispense drugs as defined in s. 465.003s.723465.003(8)without first being furnished with a prescription. 724 Section 16. Subsection (8) of section 465.0156, Florida 725 Statutes, is amended to read: 726 465.0156 Registration of nonresident pharmacies.— 727 (8) Notwithstanding s. 465.003s.465.003(10), for purposes 728 of this section, the registered pharmacy and the pharmacist 729 designated by the registered pharmacy as the prescription 730 department manager or the equivalent must be licensed in the 731 state of location in order to dispense into this state. 732 Section 17. Subsection (4) of section 465.0197, Florida 733 Statutes, is amended to read: 734 465.0197 Internet pharmacy permits.— 735 (4) Notwithstanding s. 465.003s.465.003(10), for purposes 736 of this section, the Internet pharmacy and the pharmacist 737 designated by the Internet pharmacy as the prescription 738 department manager or the equivalent must be licensed in the 739 state of location in order to dispense into this state. 740 Section 18. Section 465.1901, Florida Statutes, is amended 741 to read: 742 465.1901 Practice of orthotics and pedorthics.—The 743 provisions of chapter 468 relating to orthotics or pedorthics do 744 not apply to any licensed pharmacist or to any person acting 745 under the supervision of a licensed pharmacist. The practice of 746 orthotics or pedorthics by a pharmacist or any of the 747 pharmacist’s employees acting under the supervision of a 748 pharmacist shall be construed to be within the meaning of the 749 term “practice of the profession of pharmacy” as set forth in s. 750 465.003s.465.003(13), and shall be subject to regulation in 751 the same manner as any other pharmacy practice. The Board of 752 Pharmacy shall develop rules regarding the practice of orthotics 753 and pedorthics by a pharmacist. Any pharmacist or person under 754 the supervision of a pharmacist engaged in the practice of 755 orthotics or pedorthics is not precluded from continuing that 756 practice pending adoption of these rules. 757 Section 19. Subsection (43) of section 499.003, Florida 758 Statutes, is amended to read: 759 499.003 Definitions of terms used in this part.—As used in 760 this part, the term: 761 (43) “Prescription drug” means a prescription, medicinal, 762 or legend drug, including, but not limited to, finished dosage 763 forms or active pharmaceutical ingredients subject to, defined 764 by, or described by s. 503(b) of the Federal Food, Drug, and 765 Cosmetic Act or s. 465.003s.465.003(8), s. 499.007(13), or 766 subsection (11), subsection (46), or subsection (53), except 767 that an active pharmaceutical ingredient is a prescription drug 768 only if substantially all finished dosage forms in which it may 769 be lawfully dispensed or administered in this state are also 770 prescription drugs. 771 Section 20. Subsection (22) of section 893.02, Florida 772 Statutes, is amended to read: 773 893.02 Definitions.—The following words and phrases as used 774 in this chapter shall have the following meanings, unless the 775 context otherwise requires: 776 (22) “Prescription” means and includes an order for drugs 777 or medicinal supplies written, signed, or transmitted by word of 778 mouth, telephone, telegram, or other means of communication by a 779 duly licensed practitioner licensed by the laws of the state to 780 prescribe such drugs or medicinal supplies, issued in good faith 781 and in the course of professional practice, intended to be 782 filled, compounded, or dispensed by another person licensed by 783 the laws of the state to do so, and meeting the requirements of 784 s. 893.04. The term also includes an order for drugs or 785 medicinal supplies so transmitted or written by a physician, 786 dentist, veterinarian, or other practitioner licensed to 787 practice in a state other than Florida, but only if the 788 pharmacist called upon to fill such an order determines, in the 789 exercise of his or her professional judgment, that the order was 790 issued pursuant to a valid patient-physician relationship, that 791 it is authentic, and that the drugs or medicinal supplies so 792 ordered are considered necessary for the continuation of 793 treatment of a chronic or recurrent illness. However, if the 794 physician writing the prescription is not known to the 795 pharmacist, the pharmacist shall obtain proof to a reasonable 796 certainty of the validity of said prescription. A prescription 797 order for a controlled substance shall not be issued on the same 798 prescription blank with another prescription order for a 799 controlled substance which is named or described in a different 800 schedule, nor shall any prescription order for a controlled 801 substance be issued on the same prescription blank as a 802 prescription order for a medicinal drug, as defined in s. 803 465.003s.465.003(8), which does not fall within the definition 804 of a controlled substance as defined in this act. 805 Section 21. This act shall take effect July 1, 2013.