Bill Text: FL S1192 | 2013 | Regular Session | Introduced
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-Introduced.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-Introduced.html
Florida Senate - 2013 SB 1192 By Senator Grimsley 21-00222-13 20131192__ 1 A bill to be entitled 2 An act relating to pharmacy and controlled substance 3 prescription; amending s. 456.44, F.S.; limiting the 4 application of requirements for prescribing controlled 5 substances; requiring a physician to consult the 6 prescription drug monitoring program database before 7 prescribing certain controlled substances; authorizing 8 the board to adopt a penalty for failure to consult 9 the database; exempting nursing home residents and 10 certain physicians from requirements regarding 11 prescriptions of controlled substances; amending s. 12 458.326, F.S.; requiring a physician to consult the 13 prescription drug monitoring program database or 14 designate an agent to consult the database before 15 prescribing certain controlled substances; authorizing 16 the board to adopt a penalty for failure to consult 17 the database; amending ss. 458.3265 and 459.0137, 18 F.S.; requiring that owners of pain-management clinics 19 be licensed physicians; removing language regarding 20 nonphysician-owned pain-management clinics; providing 21 that regulation of the licensure, activity, and 22 operation of pharmacies, pharmacists, and health care 23 facilities and clinics is preempted to the state; 24 prohibiting a local government or political 25 subdivision of the state from enacting or enforcing an 26 ordinance that imposes a levy, charge, or fee upon, or 27 that otherwise regulates, pharmacies, pharmacists, and 28 health care clinics and facilities, except for 29 ordinances regarding local business taxes and land 30 development; amending s. 465.003, F.S.; defining a 31 term; conforming a cross-reference; creating s. 32 465.0065, F.S.; providing notice requirements for 33 inspection of a pharmacy; amending s. 465.016, F.S.; 34 providing additional grounds for disciplinary action; 35 conforming a cross-reference; amending s. 465.022, 36 F.S.; conforming a cross-reference; requiring a 37 pharmacy permittee to commence operations within 180 38 days after permit issuance or show good cause why 39 operations were not commenced; requiring the board to 40 establish rules; requiring a pharmacy permittee to be 41 supervised by a prescription department manager or 42 consultant pharmacist of record; amending s. 465.023, 43 F.S.; providing additional grounds for disciplinary 44 action; conforming a cross-reference; amending s. 45 893.055, F.S.; deleting an obsolete provision; 46 authorizing the prescription drug monitoring program 47 to be funded by state funds and pharmaceutical company 48 donations; amending ss. 409.9201, 458.331, 459.015, 49 465.014, 465.015, 465.0156, 465.0197, 465.1901, 50 499.003, and 893.02, F.S.; conforming cross 51 references; providing an effective date. 52 53 Be It Enacted by the Legislature of the State of Florida: 54 55 Section 1. Subsections (2) and (3) of section 456.44, 56 Florida Statutes, are amended to read: 57 456.44 Controlled substance prescribing.— 58 (2) REGISTRATION.—Effective January 1, 2012,A physician 59 licensed under chapter 458, chapter 459, chapter 461, or chapter 60 466 who prescribes more than a 30-day supply of any controlled 61 substance, listed in Schedule II, Schedule III, or Schedule IV 62 as defined in s. 893.03, over a 6-month period to any one 63 patient for the treatment of chronic nonmalignant pain, must: 64 (a) Designate himself or herself as a controlled substance 65 prescribing practitioner on the physician’s practitioner 66 profile. 67 (b) Comply with the requirements of this section and 68 applicable board rules. 69 (3) STANDARDS OF PRACTICE.—The standards of practice in 70 this section do not supersede the level of care, skill, and 71 treatment recognized in general law related to health care 72 licensure. 73 (a) A complete medical history and a physical examination 74 must be conducted before beginning any treatment and must be 75 documented in the medical record. The exact components of the 76 physical examination shall be left to the judgment of the 77 clinician who is expected to perform a physical examination 78 proportionate to the diagnosis that justifies a treatment. The 79 medical record must, at a minimum, document the nature and 80 intensity of the pain, current and past treatments for pain, 81 underlying or coexisting diseases or conditions, the effect of 82 the pain on physical and psychological function, a review of 83 previous medical records, previous diagnostic studies, and 84 history of alcohol and substance abuse. The medical record shall 85 also document the presence of one or more recognized medical 86 indications for the use of a controlled substance. Each 87 registrant must develop a written plan for assessing each 88 patient’s risk of aberrant drug-related behavior, which may 89 include patient drug testing. Registrants must assess each 90 patient’s risk for aberrant drug-related behavior and monitor 91 that risk on an ongoing basis in accordance with the plan. 92 (b) Pursuant to s. 458.326, before or during a new 93 patient’s visit for pain-treatment services, a physician shall 94 consult the prescription drug monitoring program database 95 provided under s. 893.055(2)(a) before prescribing a controlled 96 substance listed in Schedule II or Schedule III in s. 893.03. 97 The physician may designate an agent under his or her 98 supervision to consult the database. The board shall adopt rules 99 to establish a penalty for a physician who does not comply with 100 this subsection. 101 (c)(b)Each registrant must develop a written 102 individualized treatment plan for each patient. The treatment 103 plan shall state objectives that will be used to determine 104 treatment success, such as pain relief and improved physical and 105 psychosocial function, and shall indicate if any further 106 diagnostic evaluations or other treatments are planned. After 107 treatment begins, the physician shall adjust drug therapy to the 108 individual medical needs of each patient. Other treatment 109 modalities, including a rehabilitation program, shall be 110 considered depending on the etiology of the pain and the extent 111 to which the pain is associated with physical and psychosocial 112 impairment. The interdisciplinary nature of the treatment plan 113 shall be documented. 114 (d)(c)The physician shall discuss the risks and benefits 115 of the use of controlled substances, including the risks of 116 abuse and addiction, as well as physical dependence and its 117 consequences, with the patient, persons designated by the 118 patient, or the patient’s surrogate or guardian if the patient 119 is incompetent. The physician shall use a written controlled 120 substance agreement between the physician and the patient 121 outlining the patient’s responsibilities, including, but not 122 limited to: 123 1. Number and frequency of controlled substance 124 prescriptions and refills. 125 2. Patient compliance and reasons for which drug therapy 126 may be discontinued, such as a violation of the agreement. 127 3. An agreement that controlled substances for the 128 treatment of chronic nonmalignant pain shall be prescribed by a 129 single treating physician unless otherwise authorized by the 130 treating physician and documented in the medical record. 131 (e)(d)The patient shall be seen by the physician at 132 regular intervals, not to exceed 3 months, to assess the 133 efficacy of treatment, ensure that controlled substance therapy 134 remains indicated, evaluate the patient’s progress toward 135 treatment objectives, consider adverse drug effects, and review 136 the etiology of the pain. Continuation or modification of 137 therapy shall depend on the physician’s evaluation of the 138 patient’s progress. If treatment goals are not being achieved, 139 despite medication adjustments, the physician shall reevaluate 140 the appropriateness of continued treatment. The physician shall 141 monitor patient compliance in medication usage, related 142 treatment plans, controlled substance agreements, and 143 indications of substance abuse or diversion at a minimum of 3 144 month intervals. 145 (f)(e)The physician shall refer the patient as necessary 146 for additional evaluation and treatment in order to achieve 147 treatment objectives. Special attention shall be given to those 148 patients who are at risk for misusing their medications and 149 those whose living arrangements pose a risk for medication 150 misuse or diversion. The management of pain in patients with a 151 history of substance abuse or with a comorbid psychiatric 152 disorder requires extra care, monitoring, and documentation and 153 requires consultation with or referral to an addiction medicine 154 specialist or psychiatrist. 155 (g)(f)A physician registered under this section must 156 maintain accurate, current, and complete records that are 157 accessible and readily available for review and comply with the 158 requirements of this section, the applicable practice act, and 159 applicable board rules. The medical records must include, but 160 are not limited to: 161 1. The complete medical history and a physical examination, 162 including history of drug abuse or dependence. 163 2. Diagnostic, therapeutic, and laboratory results. 164 3. Evaluations and consultations. 165 4. Treatment objectives. 166 5. Discussion of risks and benefits. 167 6. Treatments. 168 7. Medications, including date, type, dosage, and quantity 169 prescribed. 170 8. Instructions and agreements. 171 9. Periodic reviews. 172 10. Results of any drug testing. 173 11. A photocopy of the patient’s government-issued photo 174 identification. 175 12. If a written prescription for a controlled substance is 176 given to the patient, a duplicate of the prescription. 177 13. The physician’s full name presented in a legible 178 manner. 179 (h)(g)Patients with signs or symptoms of substance abuse 180 shall be immediately referred to a board-certified pain 181 management physician, an addiction medicine specialist, or a 182 mental health addiction facility as it pertains to drug abuse or 183 addiction unless the physician is board-certified or board 184 eligible in pain management. Throughout the period of time 185 before receiving the consultant’s report, a prescribing 186 physician shall clearly and completely document medical 187 justification for continued treatment with controlled substances 188 and those steps taken to ensure medically appropriate use of 189 controlled substances by the patient. Upon receipt of the 190 consultant’s written report, the prescribing physician shall 191 incorporate the consultant’s recommendations for continuing, 192 modifying, or discontinuing controlled substance therapy. The 193 resulting changes in treatment shall be specifically documented 194 in the patient’s medical record. Evidence or behavioral 195 indications of diversion shall be followed by discontinuation of 196 controlled substance therapy, and the patient shall be 197 discharged, and all results of testing and actions taken by the 198 physician shall be documented in the patient’s medical record. 199 200 This subsection does not apply to a board-eligible or board 201 certified anesthesiologist, physiatrist, rheumatologist, or 202 neurologist, or to a board-certified physician who has surgical 203 privileges at a hospital or ambulatory surgery center and 204 primarily provides surgical services. This subsection does not 205 apply to a board-eligible or board-certified medical specialist 206 who has also completed a fellowship in pain medicine approved by 207 the Accreditation Council for Graduate Medical Education or the 208 American Osteopathic Association, or who is board eligible or 209 board certified in pain medicine by the American Board of Pain 210 Medicine or a board approved by the American Board of Medical 211 Specialties or the American Osteopathic Association and performs 212 interventional pain procedures of the type routinely billed 213 using surgical codes. This subsection does not apply to a 214 physician who prescribes medically necessary controlled 215 substances for a patient during an inpatient stay in a hospital 216 licensed under chapter 395 or to a resident in a facility 217 licensed under part II of chapter 400. This subsection does not 218 apply to any physician licensed under chapter 458 or chapter 459 219 who writes fewer than 50 prescriptions for a controlled 220 substance for all of his or her patients during a 1-year period. 221 Section 2. Subsection (3) of section 458.326, Florida 222 Statutes, is amended to read: 223 458.326 Intractable pain; authorized treatment.— 224 (3)(a) Notwithstanding any other provision of law, a 225 physician may prescribe or administer any controlled substance 226 under Schedules II-V, as provided for in s. 893.03, to a person 227 for the treatment of intractable pain, provided the physician 228 does so in accordance with that level of care, skill, and 229 treatment recognized by a reasonably prudent physician under 230 similar conditions and circumstances. 231 (b) Before or during a new patient’s visit for pain 232 treatment services, a physician shall consult the prescription 233 drug monitoring program database provided under s. 893.055(2)(a) 234 before prescribing a controlled substance listed in Schedule II 235 or Schedule III in s. 893.03. The physician may designate an 236 agent under his or her supervision to consult the database. The 237 board shall adopt rules to establish a penalty for a physician 238 who does not comply with this paragraph. 239 Section 3. Paragraphs (a) and (d) of subsection (1) of 240 section 458.3265, Florida Statutes, are amended, present 241 subsections (5) and (6) of that section are renumbered as 242 subsections (6) and (7), respectively, and a new subsection (5) 243 is added to that section, to read: 244 458.3265 Pain-management clinics.— 245 (1) REGISTRATION.— 246 (a)1. As used in this section, the term: 247 a. “Board eligible” means successful completion of an 248 anesthesia, physical medicine and rehabilitation, rheumatology, 249 or neurology residency program approved by the Accreditation 250 Council for Graduate Medical Education or the American 251 Osteopathic Association for a period of 6 years from successful 252 completion of such residency program. 253 b. “Chronic nonmalignant pain” means pain unrelated to 254 cancer which persists beyond the usual course of disease or the 255 injury that is the cause of the pain or more than 90 days after 256 surgery. 257 c. “Pain-management clinic” or “clinic” means any publicly 258 or privately owned facility: 259 (I) That advertises in any medium for any type of pain 260 management services; or 261 (II) Where in any month a majority of patients are 262 prescribed opioids, benzodiazepines, barbiturates, or 263 carisoprodol for the treatment of chronic nonmalignant pain. 264 2. Each pain-management clinic must register with the 265 department unless: 266 a. That clinic is licensed as a facility pursuant to 267 chapter 395; 268 b. The majority of the physicians who provide services in 269 the clinic primarily provide surgical services; 270c. The clinic is owned by a publicly held corporation whose271shares are traded on a national exchange or on the over-the272counter market and whose total assets at the end of the273corporation’s most recent fiscal quarter exceeded $50 million;274 c.d.The clinic is affiliated with an accredited medical 275 school at which training is provided for medical students, 276 residents, or fellows; 277 d.e.The clinic does not prescribe controlled substances 278 for the treatment of pain; 279f. The clinic is owned by a corporate entity exempt from280federal taxation under 26 U.S.C. s. 501(c)(3);281 e.g.The clinic is wholly owned and operated by one or more 282 board-eligible or board-certified anesthesiologists, 283 physiatrists, rheumatologists, or neurologists; or 284 f.h.The clinic is wholly owned and operated by a physician 285 multispecialty practice where one or more board-eligible or 286 board-certified medical specialists who have also completed 287 fellowships in pain medicine approved by the Accreditation 288 Council for Graduate Medical Education, or who are also board 289 certified in pain medicine by the American Board of Pain 290 Medicine or a board approved by the American Board of Medical 291 Specialties, the American Association of Physician Specialists, 292 or the American Osteopathic Association and perform 293 interventional pain procedures of the type routinely billed 294 using surgical codes. 295 (d) The department shall deny registration to any clinic 296 that is not fully owned by a physician licensed under this 297 chapter or chapter 459 or a group of physicians, each of whom is 298 licensed under this chapter or chapter 459; or that is not a 299 health care clinic licensed under part X of chapter 400 which is 300 fully owned by such physician or group of physicians. 301 (5) PREEMPTION.—This chapter preempts to the state all 302 regulation of the licensure, activity, and operation of 303 pharmacies and pharmacists as defined in chapter 465, health 304 care facilities as defined in s. 408.07, and clinics under part 305 X of chapter 400, including registration and licensing for pain 306 management clinics and practitioners. A local government or 307 political subdivision of the state may not enact or enforce an 308 ordinance that imposes a levy, charge, or fee upon, or that 309 otherwise regulates, pharmacies and pharmacists as defined in 310 chapter 465, health care facilities as defined in s. 408.07, and 311 clinics under part X of chapter 400, including services provided 312 within such facilities, except that this preemption does not 313 prohibit a local government or political subdivision from 314 enacting an ordinance regarding the following: 315 (a) Local business taxes adopted pursuant to chapter 205. 316 (b) Land use development regulations adopted pursuant to 317 chapter 163, which include regulation of any aspect of 318 development, including a subdivision, building construction, 319 sign regulation, and any other regulation concerning the 320 development of land, landscaping, or tree protection, and which 321 do not include restrictions on pain-management services, health 322 care services, or the prescribing of controlled substances. 323 However, a health care facility or clinic that treats pain or 324 provides pain-management services is a permissible use in a land 325 use or zoning category that permits hospitals, other health care 326 facilities, or clinics as defined in chapter 395, s. 408.907, or 327 under part X of chapter 400. 328 Section 4. Paragraphs (a) and (d) of subsection (1) of 329 section 459.0137, Florida Statutes, are amended, present 330 subsections (5) and (6) of that section are renumbered as 331 subsections (6) and (7), respectively, and a new subsection (5) 332 is added to that section, to read: 333 459.0137 Pain-management clinics.— 334 (1) REGISTRATION.— 335 (a)1. As used in this section, the term: 336 a. “Board eligible” means successful completion of an 337 anesthesia, physical medicine and rehabilitation, rheumatology, 338 or neurology residency program approved by the Accreditation 339 Council for Graduate Medical Education or the American 340 Osteopathic Association for a period of 6 years from successful 341 completion of such residency program. 342 b. “Chronic nonmalignant pain” means pain unrelated to 343 cancer which persists beyond the usual course of disease or the 344 injury that is the cause of the pain or more than 90 days after 345 surgery. 346 c. “Pain-management clinic” or “clinic” means any publicly 347 or privately owned facility: 348 (I) That advertises in any medium for any type of pain 349 management services; or 350 (II) Where in any month a majority of patients are 351 prescribed opioids, benzodiazepines, barbiturates, or 352 carisoprodol for the treatment of chronic nonmalignant pain. 353 2. Each pain-management clinic must register with the 354 department unless: 355 a. That clinic is licensed as a facility pursuant to 356 chapter 395; 357 b. The majority of the physicians who provide services in 358 the clinic primarily provide surgical services; 359c. The clinic is owned by a publicly held corporation whose360shares are traded on a national exchange or on the over-the361counter market and whose total assets at the end of the362corporation’s most recent fiscal quarter exceeded $50 million;363 c.d.The clinic is affiliated with an accredited medical 364 school at which training is provided for medical students, 365 residents, or fellows; 366 d.e.The clinic does not prescribe controlled substances 367 for the treatment of pain; 368f. The clinic is owned by a corporate entity exempt from369federal taxation under 26 U.S.C. s. 501(c)(3);370 e.g.The clinic is wholly owned and operated by one or more 371 board-eligible or board-certified anesthesiologists, 372 physiatrists, rheumatologists, or neurologists; or 373 f.h.The clinic is wholly owned and operated by a physician 374 multispecialty practice where one or more board-eligible or 375 board-certified medical specialists who have also completed 376 fellowships in pain medicine approved by the Accreditation 377 Council for Graduate Medical Education or the American 378 Osteopathic Association, or who are also board-certified in pain 379 medicine by the American Board of Pain Medicine or a board 380 approved by the American Board of Medical Specialties, the 381 American Association of Physician Specialists, or the American 382 Osteopathic Association and perform interventional pain 383 procedures of the type routinely billed using surgical codes. 384 (d) The department shall deny registration to any clinic 385 that is not fully owned by a physician licensed under chapter 386 458 or this chapter or a group of physicians, each of whom is 387 licensed under chapter 458 or this chapter; or that is not a 388 health care clinic licensed under part X of chapter 400 which is 389 fully owned by such physician or group of physicians. 390 (5) PREEMPTION.—This chapter preempts to the state all 391 regulation of the licensure, activity, and operation of 392 pharmacies and pharmacists as defined in chapter 465, health 393 care facilities as defined in s. 408.07, and clinics under part 394 X of chapter 400, including registration and licensing for pain 395 management clinics and practitioners. A local government or 396 political subdivision of the state may not enact or enforce an 397 ordinance that imposes a levy, charge, or fee upon, or that 398 otherwise regulates, pharmacies and pharmacists as defined in 399 chapter 465, health care facilities as defined in s. 408.07, and 400 clinics under part X of chapter 400, including services provided 401 within such facilities, except that this preemption does not 402 prohibit a local government or political subdivision from 403 enacting an ordinance regarding the following: 404 (a) Local business taxes adopted pursuant to chapter 205. 405 (b) Land use development regulations adopted pursuant to 406 chapter 163, which include regulation of any aspect of 407 development, including a subdivision, building construction, 408 sign regulation, and any other regulation concerning the 409 development of land, landscaping, or tree protection, and which 410 do not include restrictions on pain-management services, health 411 care services, and the prescribing of controlled substances. 412 However, a health care facility or clinic that treats pain or 413 provides pain-management services is a permissible use in a land 414 use or zoning category that permits hospitals, other health care 415 facilities, or clinics as defined in chapter 395, s. 408.907, or 416 under part X of chapter 400. 417 Section 5. Present subsections (1) through (17) of section 418 465.003, Florida Statutes, are renumbered as subsections (2) 419 through (18), respectively, paragraph (a) of present subsection 420 (11) of that section is amended, and a new subsection (1) is 421 added to that section, to read: 422 465.003 Definitions.—As used in this chapter, the term: 423 (1) “Abandoned” means the status of a person who is issued 424 a pharmacy permit but fails to commence pharmacy operations 425 within 180 days after issuance of the pharmacy permit without 426 good cause or fails to follow pharmacy closure requirements as 427 set by the board. 428 (12)(11)(a) “Pharmacy” includes a community pharmacy, an 429 institutional pharmacy, a nuclear pharmacy, a special pharmacy, 430 and an Internet pharmacy. 431 1. The term “community pharmacy” includes every location 432 where medicinal drugs are compounded, dispensed, stored, or sold 433 or where prescriptions are filled or dispensed on an outpatient 434 basis. 435 2. The term “institutional pharmacy” includes every 436 location in a hospital, clinic, nursing home, dispensary, 437 sanitarium, extended care facility, or other facility, 438 hereinafter referred to as “health care institutions,” where 439 medicinal drugs are compounded, dispensed, stored, or sold. 440 3. The term “nuclear pharmacy” includes every location 441 where radioactive drugs and chemicals within the classification 442 of medicinal drugs are compounded, dispensed, stored, or sold. 443 The term “nuclear pharmacy” does not include hospitals licensed 444 under chapter 395 or the nuclear medicine facilities of such 445 hospitals. 446 4. The term “special pharmacy” includes every location 447 where medicinal drugs are compounded, dispensed, stored, or sold 448 if such locations are not otherwise defined in this subsection. 449 5. The term “Internet pharmacy” includes locations not 450 otherwise licensed or issued a permit under this chapter, within 451 or outside this state, which use the Internet to communicate 452 with or obtain information from consumers in this state and use 453 such communication or information to fill or refill 454 prescriptions or to dispense, distribute, or otherwise engage in 455 the practice of pharmacy in this state. Any act described in 456 this definition constitutes the practice of pharmacy as defined 457 in subsection (14)(13). 458 Section 6. Section 465.0065, Florida Statutes, is created 459 to read: 460 465.0065 Notices; form and service.—Each notice served by 461 the department pursuant to this chapter must be in writing and 462 must be delivered personally by an agent of the department or by 463 certified mail to the pharmacy permittee. If the pharmacy 464 permittee refuses to accept service or evades service or if the 465 agent is otherwise unable to carry out service after due 466 diligence, the department may post the notice in a conspicuous 467 place at the pharmacy. 468 Section 7. Paragraphs (e) and (s) of subsection (1) of 469 section 465.016, Florida Statutes, are amended, and paragraph 470 (u) is added to that subsection to read: 471 465.016 Disciplinary actions.— 472 (1) The following acts constitute grounds for denial of a 473 license or disciplinary action, as specified in s. 456.072(2): 474 (e) Violating chapter 499; 21 U.S.C. ss. 301-392, known as 475 the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et 476 seq., known as the Comprehensive Drug Abuse Prevention and 477 Control Act; or chapter 893 or rules adopted thereunder. 478 (s) Dispensing any medicinal drug based upon a 479 communication that purports to be a prescription as defined by 480 s. 465.003s.465.003(14)or s. 893.02 when the pharmacist knows 481 or has reason to believe that the purported prescription is not 482 based upon a valid practitioner-patient relationship. 483 (u) Misappropriating drugs, supplies, or equipment from a 484 pharmacy permittee. 485 Section 8. Paragraph (j) of subsection (5) of section 486 465.022, Florida Statutes, is amended, present subsections (10) 487 through (14) are renumbered as subsections (11) through (15), 488 respectively, present subsection (10) of that section is 489 amended, and a new subsection (10) is added to that section, to 490 read: 491 465.022 Pharmacies; general requirements; fees.— 492 (5) The department or board shall deny an application for a 493 pharmacy permit if the applicant or an affiliated person, 494 partner, officer, director, or prescription department manager 495 or consultant pharmacist of record of the applicant: 496 (j) Has dispensed any medicinal drug based upon a 497 communication that purports to be a prescription as defined by 498 s. 465.003s.465.003(14)or s. 893.02 when the pharmacist knows 499 or has reason to believe that the purported prescription is not 500 based upon a valid practitioner-patient relationship that 501 includes a documented patient evaluation, including history and 502 a physical examination adequate to establish the diagnosis for 503 which any drug is prescribed and any other requirement 504 established by board rule under chapter 458, chapter 459, 505 chapter 461, chapter 463, chapter 464, or chapter 466. 506 507 For felonies in which the defendant entered a plea of guilty or 508 nolo contendere in an agreement with the court to enter a 509 pretrial intervention or drug diversion program, the department 510 shall deny the application if upon final resolution of the case 511 the licensee has failed to successfully complete the program. 512 (10) The permittee shall commence pharmacy operations 513 within 180 days after issuance of the permit, or show good cause 514 to the department why pharmacy operations were not commenced. 515 Commencement of pharmacy operations includes, but is not limited 516 to, acts within the scope of the practice of pharmacy, ordering 517 or receiving drugs, and other similar activities. The board 518 shall establish rules regarding commencement of pharmacy 519 operations. 520 (11)(10)A pharmacy permittee shall be supervised by a 521 prescription department manager or consultant pharmacist of 522 record at all times. A permittee must notify the department, on 523 a form approved by the board, within 10 days after any change in 524 prescription department manager or consultant pharmacist of 525 record. 526 Section 9. Subsection (1) of section 465.023, Florida 527 Statutes, is amended to read: 528 465.023 Pharmacy permittee; disciplinary action.— 529 (1) The department or the board may revoke or suspend the 530 permit of any pharmacy permittee, and may fine, place on 531 probation, or otherwise discipline any pharmacy permittee if the 532 permittee, or any affiliated person, partner, officer, director, 533 or agent of the permittee, including a person fingerprinted 534 under s. 465.022(3), has: 535 (a) Obtained a permit by misrepresentation or fraud or 536 through an error of the department or the board; 537 (b) Attempted to procure, or has procured, a permit for any 538 other person by making, or causing to be made, any false 539 representation; 540 (c) Violated any of the requirements of this chapter or any 541 of the rules of the Board of Pharmacy; of chapter 499, known as 542 the “Florida Drug and Cosmetic Act”; of 21 U.S.C. ss. 301-392, 543 known as the “Federal Food, Drug, and Cosmetic Act”; of 21 544 U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse 545 Prevention and Control Act; or of chapter 893 or rules adopted 546 thereunder; 547 (d) Been convicted or found guilty, regardless of 548 adjudication, of a felony or any other crime involving moral 549 turpitude in any of the courts of this state, of any other 550 state, or of the United States; 551 (e) Been convicted or disciplined by a regulatory agency of 552 the Federal Government or a regulatory agency of another state 553 for any offense that would constitute a violation of this 554 chapter; 555 (f) Been convicted of, or entered a plea of guilty or nolo 556 contendere to, regardless of adjudication, a crime in any 557 jurisdiction which relates to the practice of, or the ability to 558 practice, the profession of pharmacy; 559 (g) Been convicted of, or entered a plea of guilty or nolo 560 contendere to, regardless of adjudication, a crime in any 561 jurisdiction which relates to health care fraud; or 562 (h) Dispensed any medicinal drug based upon a communication 563 that purports to be a prescription as defined by s. 465.003s.564465.003(14)or s. 893.02 when the pharmacist knows or has reason 565 to believe that the purported prescription is not based upon a 566 valid practitioner-patient relationship that includes a 567 documented patient evaluation, including history and a physical 568 examination adequate to establish the diagnosis for which any 569 drug is prescribed and any other requirement established by 570 board rule under chapter 458, chapter 459, chapter 461, chapter 571 463, chapter 464, or chapter 466. 572 Section 10. Paragraph (b) of subsection (2), subsection 573 (10), and paragraph (c) of subsection (11) of section 893.055, 574 Florida Statutes, are amended to read: 575 893.055 Prescription drug monitoring program.— 576 (2) 577 (b) The department, when the direct support organization578receives at least $20,000 in nonstate moneys or the state579receives at least $20,000 in federal grants for the prescription580drug monitoring program,shall adopt rules as necessary 581 concerning the reporting, accessing the database, evaluation, 582 management, development, implementation, operation, security, 583 and storage of information within the system, including rules 584 for when patient advisory reports are provided to pharmacies and 585 prescribers. The patient advisory report shall be provided in 586 accordance with s. 893.13(7)(a)8. The department shall work with 587 the professional health care licensure boards, such as the Board 588 of Medicine, the Board of Osteopathic Medicine, and the Board of 589 Pharmacy; other appropriate organizations, such as the Florida 590 Pharmacy Association, the Florida Medical Association, the 591 Florida Retail Federation, and the Florida Osteopathic Medical 592 Association, including those relating to pain management; and 593 the Attorney General, the Department of Law Enforcement, and the 594 Agency for Health Care Administration to develop rules 595 appropriate for the prescription drug monitoring program. 596 (10) All costs incurred by the department in administering 597 the prescription drug monitoring program shall be funded through 598 state funds, federal grants, or private funding applied for or 599 received by the state. The department may not commit funds for 600 the monitoring program without ensuring funding is available. 601The prescription drug monitoring program and the implementation602thereof are contingent upon receipt of the nonstate funding.The 603 department and state government shall cooperate with the direct 604 support organization established pursuant to subsection (11) in 605 seeking state funds, federal grant funds, other nonstate grant 606 funds, gifts, donations, or other private moneys for the 607 department ifso long asthe costs of doing so are not 608 considered material. Nonmaterial costs for this purpose include, 609 but are not limited to, the costs of mailing and personnel 610 assigned to research or apply for a grant. Notwithstanding the 611 exemptions to competitive-solicitation requirements under s. 612 287.057(3)(f), the department shall comply with the competitive 613 solicitation requirements under s. 287.057 for the procurement 614 of any goods or services required by this section. Funds 615 provided, directly or indirectly, by prescription drug 616 manufacturers may not be used to implement the program. 617 (11) The department may establish a direct-support 618 organization that has a board consisting of at least five 619 members to provide assistance, funding, and promotional support 620 for the activities authorized for the prescription drug 621 monitoring program. 622 (c) The State Surgeon General shall appoint a board of 623 directors for the direct-support organization. Members of the 624 board shall serve at the pleasure of the State Surgeon General. 625 The State Surgeon General shall provide guidance to members of 626 the board to ensure that moneys received by the direct-support 627 organization are not received from inappropriate sources. 628 Inappropriate sources include, but are not limited to, donors, 629 grantors, persons, andororganizations, excluding 630 pharmaceutical companies, that may monetarily or substantively 631 benefit from the purchase of goods or services by the department 632 in furtherance of the prescription drug monitoring program. 633 Section 11. Subsection (1) of section 409.9201, Florida 634 Statutes, is amended to read: 635 409.9201 Medicaid fraud.— 636 (1) As used in this section, the term: 637 (a) “Prescription drug” means any drug, including, but not 638 limited to, finished dosage forms or active ingredients that are 639 subject to, defined by, or described by s. 503(b) of the Federal 640 Food, Drug, and Cosmetic Act or by s. 465.003s.465.003(8), s. 641 499.003(46) or (53) or s. 499.007(13). 642 (b) “Value” means the amount billed to the Medicaid program 643 for the property dispensed or the market value of a legend drug 644 or goods or services at the time and place of the offense. If 645 the market value cannot be determined, the term means the 646 replacement cost of the legend drug or goods or services within 647 a reasonable time after the offense. 648 649 The value of individual items of the legend drugs or goods or 650 services involved in distinct transactions committed during a 651 single scheme or course of conduct, whether involving a single 652 person or several persons, may be aggregated when determining 653 the punishment for the offense. 654 Section 12. Paragraph (pp) of subsection (1) of section 655 458.331, Florida Statutes, is amended to read: 656 458.331 Grounds for disciplinary action; action by the 657 board and department.— 658 (1) The following acts constitute grounds for denial of a 659 license or disciplinary action, as specified in s. 456.072(2): 660 (pp) Applicable to a licensee who serves as the designated 661 physician of a pain-management clinic as defined in s. 458.3265 662 or s. 459.0137: 663 1. Registering a pain-management clinic through 664 misrepresentation or fraud; 665 2. Procuring, or attempting to procure, the registration of 666 a pain-management clinic for any other person by making or 667 causing to be made, any false representation; 668 3. Failing to comply with any requirement of chapter 499, 669 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the 670 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., 671 the Drug Abuse Prevention and Control Act; or chapter 893, the 672 Florida Comprehensive Drug Abuse Prevention and Control Act; 673 4. Being convicted or found guilty of, regardless of 674 adjudication to, a felony or any other crime involving moral 675 turpitude, fraud, dishonesty, or deceit in any jurisdiction of 676 the courts of this state, of any other state, or of the United 677 States; 678 5. Being convicted of, or disciplined by a regulatory 679 agency of the Federal Government or a regulatory agency of 680 another state for, any offense that would constitute a violation 681 of this chapter; 682 6. Being convicted of, or entering a plea of guilty or nolo 683 contendere to, regardless of adjudication, a crime in any 684 jurisdiction of the courts of this state, of any other state, or 685 of the United States which relates to the practice of, or the 686 ability to practice, a licensed health care profession; 687 7. Being convicted of, or entering a plea of guilty or nolo 688 contendere to, regardless of adjudication, a crime in any 689 jurisdiction of the courts of this state, of any other state, or 690 of the United States which relates to health care fraud; 691 8. Dispensing any medicinal drug based upon a communication 692 that purports to be a prescription as defined in s. 465.003s.693465.003(14)or s. 893.02 if the dispensing practitioner knows or 694 has reason to believe that the purported prescription is not 695 based upon a valid practitioner-patient relationship; or 696 9. Failing to timely notify the board of the date of his or 697 her termination from a pain-management clinic as required by s. 698 458.3265(2). 699 Section 13. Paragraph (rr) of subsection (1) of section 700 459.015, Florida Statutes, is amended to read: 701 459.015 Grounds for disciplinary action; action by the 702 board and department.— 703 (1) The following acts constitute grounds for denial of a 704 license or disciplinary action, as specified in s. 456.072(2): 705 (rr) Applicable to a licensee who serves as the designated 706 physician of a pain-management clinic as defined in s. 458.3265 707 or s. 459.0137: 708 1. Registering a pain-management clinic through 709 misrepresentation or fraud; 710 2. Procuring, or attempting to procure, the registration of 711 a pain-management clinic for any other person by making or 712 causing to be made, any false representation; 713 3. Failing to comply with any requirement of chapter 499, 714 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the 715 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., 716 the Drug Abuse Prevention and Control Act; or chapter 893, the 717 Florida Comprehensive Drug Abuse Prevention and Control Act; 718 4. Being convicted or found guilty of, regardless of 719 adjudication to, a felony or any other crime involving moral 720 turpitude, fraud, dishonesty, or deceit in any jurisdiction of 721 the courts of this state, of any other state, or of the United 722 States; 723 5. Being convicted of, or disciplined by a regulatory 724 agency of the Federal Government or a regulatory agency of 725 another state for, any offense that would constitute a violation 726 of this chapter; 727 6. Being convicted of, or entering a plea of guilty or nolo 728 contendere to, regardless of adjudication, a crime in any 729 jurisdiction of the courts of this state, of any other state, or 730 of the United States which relates to the practice of, or the 731 ability to practice, a licensed health care profession; 732 7. Being convicted of, or entering a plea of guilty or nolo 733 contendere to, regardless of adjudication, a crime in any 734 jurisdiction of the courts of this state, of any other state, or 735 of the United States which relates to health care fraud; 736 8. Dispensing any medicinal drug based upon a communication 737 that purports to be a prescription as defined in s. 465.003s.738465.003(14)or s. 893.02 if the dispensing practitioner knows or 739 has reason to believe that the purported prescription is not 740 based upon a valid practitioner-patient relationship; or 741 9. Failing to timely notify the board of the date of his or 742 her termination from a pain-management clinic as required by s. 743 459.0137(2). 744 Section 14. Subsection (1) of section 465.014, Florida 745 Statutes, is amended to read: 746 465.014 Pharmacy technician.— 747 (1) A person other than a licensed pharmacist or pharmacy 748 intern may not engage in the practice of the profession of 749 pharmacy, except that a licensed pharmacist may delegate to 750 pharmacy technicians who are registered pursuant to this section 751 those duties, tasks, and functions that do not fall within the 752 purview of s. 465.003s.465.003(13). All such delegated acts 753 shall be performed under the direct supervision of a licensed 754 pharmacist who shall be responsible for all such acts performed 755 by persons under his or her supervision. A pharmacy registered 756 technician, under the supervision of a pharmacist, may initiate 757 or receive communications with a practitioner or his or her 758 agent, on behalf of a patient, regarding refill authorization 759 requests. A licensed pharmacist may not supervise more than one 760 registered pharmacy technician unless otherwise permitted by the 761 guidelines adopted by the board. The board shall establish 762 guidelines to be followed by licensees or permittees in 763 determining the circumstances under which a licensed pharmacist 764 may supervise more than one but not more than three pharmacy 765 technicians. 766 Section 15. Paragraph (c) of subsection (2) of section 767 465.015, Florida Statutes, is amended to read: 768 465.015 Violations and penalties.— 769 (2) It is unlawful for any person: 770 (c) To sell or dispense drugs as defined in s. 465.003s.771465.003(8)without first being furnished with a prescription. 772 Section 16. Subsection (8) of section 465.0156, Florida 773 Statutes, is amended to read: 774 465.0156 Registration of nonresident pharmacies.— 775 (8) Notwithstanding s. 465.003s.465.003(10), for purposes 776 of this section, the registered pharmacy and the pharmacist 777 designated by the registered pharmacy as the prescription 778 department manager or the equivalent must be licensed in the 779 state of location in order to dispense into this state. 780 Section 17. Subsection (4) of section 465.0197, Florida 781 Statutes, is amended to read: 782 465.0197 Internet pharmacy permits.— 783 (4) Notwithstanding s. 465.003s.465.003(10), for purposes 784 of this section, the Internet pharmacy and the pharmacist 785 designated by the Internet pharmacy as the prescription 786 department manager or the equivalent must be licensed in the 787 state of location in order to dispense into this state. 788 Section 18. Section 465.1901, Florida Statutes, is amended 789 to read: 790 465.1901 Practice of orthotics and pedorthics.—The 791 provisions of chapter 468 relating to orthotics or pedorthics do 792 not apply to any licensed pharmacist or to any person acting 793 under the supervision of a licensed pharmacist. The practice of 794 orthotics or pedorthics by a pharmacist or any of the 795 pharmacist’s employees acting under the supervision of a 796 pharmacist shall be construed to be within the meaning of the 797 term “practice of the profession of pharmacy” as set forth in s. 798 465.003s.465.003(13), and shall be subject to regulation in 799 the same manner as any other pharmacy practice. The Board of 800 Pharmacy shall develop rules regarding the practice of orthotics 801 and pedorthics by a pharmacist. Any pharmacist or person under 802 the supervision of a pharmacist engaged in the practice of 803 orthotics or pedorthics is not precluded from continuing that 804 practice pending adoption of these rules. 805 Section 19. Subsection (43) of section 499.003, Florida 806 Statutes, is amended to read: 807 499.003 Definitions of terms used in this part.—As used in 808 this part, the term: 809 (43) “Prescription drug” means a prescription, medicinal, 810 or legend drug, including, but not limited to, finished dosage 811 forms or active pharmaceutical ingredients subject to, defined 812 by, or described by s. 503(b) of the Federal Food, Drug, and 813 Cosmetic Act or s. 465.003s.465.003(8), s. 499.007(13), or 814 subsection (11), subsection (46), or subsection (53), except 815 that an active pharmaceutical ingredient is a prescription drug 816 only if substantially all finished dosage forms in which it may 817 be lawfully dispensed or administered in this state are also 818 prescription drugs. 819 Section 20. Subsection (22) of section 893.02, Florida 820 Statutes, is amended to read: 821 893.02 Definitions.—The following words and phrases as used 822 in this chapter shall have the following meanings, unless the 823 context otherwise requires: 824 (22) “Prescription” means and includes an order for drugs 825 or medicinal supplies written, signed, or transmitted by word of 826 mouth, telephone, telegram, or other means of communication by a 827 duly licensed practitioner licensed by the laws of the state to 828 prescribe such drugs or medicinal supplies, issued in good faith 829 and in the course of professional practice, intended to be 830 filled, compounded, or dispensed by another person licensed by 831 the laws of the state to do so, and meeting the requirements of 832 s. 893.04. The term also includes an order for drugs or 833 medicinal supplies so transmitted or written by a physician, 834 dentist, veterinarian, or other practitioner licensed to 835 practice in a state other than Florida, but only if the 836 pharmacist called upon to fill such an order determines, in the 837 exercise of his or her professional judgment, that the order was 838 issued pursuant to a valid patient-physician relationship, that 839 it is authentic, and that the drugs or medicinal supplies so 840 ordered are considered necessary for the continuation of 841 treatment of a chronic or recurrent illness. However, if the 842 physician writing the prescription is not known to the 843 pharmacist, the pharmacist shall obtain proof to a reasonable 844 certainty of the validity of said prescription. A prescription 845 order for a controlled substance shall not be issued on the same 846 prescription blank with another prescription order for a 847 controlled substance which is named or described in a different 848 schedule, nor shall any prescription order for a controlled 849 substance be issued on the same prescription blank as a 850 prescription order for a medicinal drug, as defined in s. 851 465.003s.465.003(8), which does not fall within the definition 852 of a controlled substance as defined in this act. 853 Section 21. This act shall take effect July 1, 2013.