Bill Text: FL S1192 | 2013 | Regular Session | Comm Sub
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Provision of Health Care with Controlled Substances
Spectrum: Slight Partisan Bill (? 3-1)
Status: (Failed) 2013-05-03 - Died in Messages [S1192 Detail]
Download: Florida-2013-S1192-Comm_Sub.html
Bill Title: Provision of Health Care with Controlled Substances
Spectrum: Slight Partisan Bill (? 3-1)
Status: (Failed) 2013-05-03 - Died in Messages [S1192 Detail]
Download: Florida-2013-S1192-Comm_Sub.html
Florida Senate - 2013 CS for CS for CS for SB 1192 By the Committees on Appropriations; Community Affairs; and Health Policy; and Senator Grimsley 576-04972-13 20131192c3 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 activity, and operation of pain-management clinics is 53 preempted to the state under certain circumstances; 54 authorizing a local government or political 55 subdivision of the state to enact certain ordinances 56 regarding local business taxes and land development; 57 amending ss. 409.9201, 458.331, 459.015, 465.014, 58 465.015, 465.0156, 465.0197, 465.1901, 499.003, and 59 893.02, F.S.; conforming cross-references; providing 60 an effective date. 61 62 Be It Enacted by the Legislature of the State of Florida: 63 64 Section 1. Section 456.44, Florida Statutes, is amended to 65 read: 66 456.44 Controlled substance prescribing.— 67 (1) DEFINITIONS.— 68 (a) “Addiction medicine specialist” means a board-certified 69 psychiatrist with a subspecialty certification in addiction 70 medicine or who is eligible for such subspecialty certification 71 in addiction medicine, an addiction medicine physician certified 72 or eligible for certification by the American Society of 73 Addiction Medicine, or an osteopathic physician who holds a 74 certificate of added qualification in Addiction Medicine through 75 the American Osteopathic Association. 76 (b) “Adverse incident” means any incident set forth in s. 77 458.351(4)(a)-(e) or s. 459.026(4)(a)-(e). 78 (c) “Board-certified pain management physician” means a 79 physician who possesses board certification in pain medicine by 80 the American Board of Pain Medicine, board certification by the 81 American Board of Interventional Pain Physicians, or board 82 certification or subcertification in pain management or pain 83 medicine by a specialty board recognized by the American 84 Association of Physician Specialists or the American Board of 85 Medical Specialties or an osteopathic physician who holds a 86 certificate in Pain Management by the American Osteopathic 87 Association. 88 (d) “Board eligible” means successful completion of an 89 anesthesia, physical medicine and rehabilitation, rheumatology, 90 or neurology residency program approved by the Accreditation 91 Council for Graduate Medical Education or the American 92 Osteopathic Association for a period of 6 years from successful 93 completion of such residency program. 94 (e) “Chronic nonmalignant pain” means pain unrelated to 95 cancer which persists beyond the usual course of disease or the 96 injury that is the cause of the pain or more than 90 days after 97 surgery. 98 (f) “Mental health addiction facility” means a facility 99 licensed under chapter 394 or chapter 397. 100 (2) REGISTRATION.—Effective January 1, 2012,A physician 101 licensed under chapter 458, chapter 459, chapter 461, or chapter 102 466 who prescribes more than a 30-day supply of any controlled 103 substance, listed in Schedule II, Schedule III, or Schedule IV 104 as defined in s. 893.03, over a 6-month period to any one 105 patient for the treatment of chronic nonmalignant pain, must: 106 (a) Designate himself or herself as a controlled substance 107 prescribing practitioner on the physician’s practitioner 108 profile. 109 (b) Comply with the requirements of this section and 110 applicable board rules. 111 (3) STANDARDS OF PRACTICE.—The standards of practice in 112 this section do not supersede the level of care, skill, and 113 treatment recognized in general law related to health care 114 licensure. 115 (a) A complete medical history and a physical examination 116 must be conducted before beginning any treatment and must be 117 documented in the medical record. The exact components of the 118 physical examination shall be left to the judgment of the 119 clinician who is expected to perform a physical examination 120 proportionate to the diagnosis that justifies a treatment. The 121 medical record must, at a minimum, document the nature and 122 intensity of the pain, current and past treatments for pain, 123 underlying or coexisting diseases or conditions, the effect of 124 the pain on physical and psychological function, a review of 125 previous medical records, previous diagnostic studies, and 126 history of alcohol and substance abuse. The medical record shall 127 also document the presence of one or more recognized medical 128 indications for the use of a controlled substance. Each 129 registrant must develop a written plan for assessing each 130 patient’s risk of aberrant drug-related behavior, which may 131 include patient drug testing. Registrants must assess each 132 patient’s risk for aberrant drug-related behavior and monitor 133 that risk on an ongoing basis in accordance with the plan. 134 (b) Before or during a new patient’s visit for services for 135 the treatment of pain at a pain-management clinic registered 136 under s. 458.3265 or s. 459.0137, a physician shall consult the 137 prescription drug monitoring program database provided under s. 138 893.055(2)(a) before prescribing a controlled substance listed 139 in Schedule II or Schedule III in s. 893.03. The physician may 140 designate an agent under his or her supervision to consult the 141 database. The Board of Medicine under chapter 458 and the Board 142 of Osteopathic Medicine under chapter 459 shall adopt rules to 143 establish a penalty for a physician who does not comply with 144 this subsection. 145 (c)(b)Each registrant must develop a written 146 individualized treatment plan for each patient. The treatment 147 plan shall state objectives that will be used to determine 148 treatment success, such as pain relief and improved physical and 149 psychosocial function, and shall indicate if any further 150 diagnostic evaluations or other treatments are planned. After 151 treatment begins, the physician shall adjust drug therapy to the 152 individual medical needs of each patient. Other treatment 153 modalities, including a rehabilitation program, shall be 154 considered depending on the etiology of the pain and the extent 155 to which the pain is associated with physical and psychosocial 156 impairment. The interdisciplinary nature of the treatment plan 157 shall be documented. 158 (d)(c)The physician shall discuss the risks and benefits 159 of the use of controlled substances, including the risks of 160 abuse and addiction, as well as physical dependence and its 161 consequences, with the patient, persons designated by the 162 patient, or the patient’s surrogate or guardian if the patient 163 is incompetent. The physician shall use a written controlled 164 substance agreement between the physician and the patient 165 outlining the patient’s responsibilities, including, but not 166 limited to: 167 1. Number and frequency of controlled substance 168 prescriptions and refills. 169 2. Patient compliance and reasons for which drug therapy 170 may be discontinued, such as a violation of the agreement. 171 3. An agreement that controlled substances for the 172 treatment of chronic nonmalignant pain shall be prescribed by a 173 single treating physician unless otherwise authorized by the 174 treating physician and documented in the medical record. 175 (e)(d)The patient shall be seen by the physician at 176 regular intervals, not to exceed 3 months, to assess the 177 efficacy of treatment, ensure that controlled substance therapy 178 remains indicated, evaluate the patient’s progress toward 179 treatment objectives, consider adverse drug effects, and review 180 the etiology of the pain. Continuation or modification of 181 therapy shall depend on the physician’s evaluation of the 182 patient’s progress. If treatment goals are not being achieved, 183 despite medication adjustments, the physician shall reevaluate 184 the appropriateness of continued treatment. The physician shall 185 monitor patient compliance in medication usage, related 186 treatment plans, controlled substance agreements, and 187 indications of substance abuse or diversion at a minimum of 3 188 month intervals. 189 (f)(e)The physician shall refer the patient as necessary 190 for additional evaluation and treatment in order to achieve 191 treatment objectives. Special attention shall be given to those 192 patients who are at risk for misusing their medications and 193 those whose living arrangements pose a risk for medication 194 misuse or diversion. The management of pain in patients with a 195 history of substance abuse or with a comorbid psychiatric 196 disorder requires extra care, monitoring, and documentation and 197 requires consultation with or referral to an addiction medicine 198 specialist or psychiatrist. 199 (g)(f)A physician registered under this section must 200 maintain accurate, current, and complete records that are 201 accessible and readily available for review and comply with the 202 requirements of this section, the applicable practice act, and 203 applicable board rules. The medical records must include, but 204 are not limited to: 205 1. The complete medical history and a physical examination, 206 including history of drug abuse or dependence. 207 2. Diagnostic, therapeutic, and laboratory results. 208 3. Evaluations and consultations. 209 4. Treatment objectives. 210 5. Discussion of risks and benefits. 211 6. Treatments. 212 7. Medications, including date, type, dosage, and quantity 213 prescribed. 214 8. Instructions and agreements. 215 9. Periodic reviews. 216 10. Results of any drug testing. 217 11. A photocopy of the patient’s government-issued photo 218 identification. 219 12. If a written prescription for a controlled substance is 220 given to the patient, a duplicate of the prescription. 221 13. The physician’s full name presented in a legible 222 manner. 223 (h)(g)Patients with signs or symptoms of substance abuse 224 shall be immediately referred to a board-certified pain 225 management physician, an addiction medicine specialist, or a 226 mental health addiction facility as it pertains to drug abuse or 227 addiction unless the physician is board-certified or board 228 eligible in pain management. Throughout the period of time 229 before receiving the consultant’s report, a prescribing 230 physician shall clearly and completely document medical 231 justification for continued treatment with controlled substances 232 and those steps taken to ensure medically appropriate use of 233 controlled substances by the patient. Upon receipt of the 234 consultant’s written report, the prescribing physician shall 235 incorporate the consultant’s recommendations for continuing, 236 modifying, or discontinuing controlled substance therapy. The 237 resulting changes in treatment shall be specifically documented 238 in the patient’s medical record. Evidence or behavioral 239 indications of diversion shall be followed by discontinuation of 240 controlled substance therapy, and the patient shall be 241 discharged, and all results of testing and actions taken by the 242 physician shall be documented in the patient’s medical record. 243 244 This sectionsubsectiondoes not apply to a board-eligible or 245 board-certified anesthesiologist, physiatrist, rheumatologist, 246 or neurologist, or to a board-certified physician who has 247 surgical privileges at a hospital or ambulatory surgery center 248 and primarily provides surgical services. This section 249subsectiondoes not apply to a board-eligible or board-certified 250 medical specialist who has also completed a fellowship in pain 251 medicine approved by the Accreditation Council for Graduate 252 Medical Education or the American Osteopathic Association, or 253 who is board eligible or board certified in pain medicine by the 254 American Board of Pain Medicine or a board approved by the 255 American Board of Medical Specialties or the American 256 Osteopathic Association and performs interventional pain 257 procedures of the type routinely billed using surgical codes. 258 This sectionsubsectiondoes not apply to a physician who 259 prescribes medically necessary controlled substances for a 260 patient during an inpatient stay in a hospital licensed under 261 chapter 395 or to a resident in a facility licensed under part 262 II of chapter 400. This section does not apply to a physician 263 licensed under chapter 458 or chapter 459 who writes fewer than 264 50 prescriptions for a controlled substance for all of his or 265 her patients during a 1-year period. 266 Section 2. Present subsections (1) through (17) of section 267 465.003, Florida Statutes, are renumbered as subsections (2) 268 through (18), respectively, paragraph (a) of present subsection 269 (11) of that section is amended, and a new subsection (1) is 270 added to that section, to read: 271 465.003 Definitions.—As used in this chapter, the term: 272 (1) “Abandoned” means the status of a pharmacy permit of a 273 person or entity that was issued the permit but fails to 274 commence pharmacy operations within 180 days after issuance of 275 the permit without good cause or fails to follow pharmacy 276 closure requirements as set by the board. 277 (12)(11)(a) “Pharmacy” includes a community pharmacy, an 278 institutional pharmacy, a nuclear pharmacy, a special pharmacy, 279 and an Internet pharmacy. 280 1. The term “community pharmacy” includes every location 281 where medicinal drugs are compounded, dispensed, stored, or sold 282 or where prescriptions are filled or dispensed on an outpatient 283 basis. 284 2. The term “institutional pharmacy” includes every 285 location in a hospital, clinic, nursing home, dispensary, 286 sanitarium, extended care facility, or other facility, 287 hereinafter referred to as “health care institutions,” where 288 medicinal drugs are compounded, dispensed, stored, or sold. 289 3. The term “nuclear pharmacy” includes every location 290 where radioactive drugs and chemicals within the classification 291 of medicinal drugs are compounded, dispensed, stored, or sold. 292 The term “nuclear pharmacy” does not include hospitals licensed 293 under chapter 395 or the nuclear medicine facilities of such 294 hospitals. 295 4. The term “special pharmacy” includes every location 296 where medicinal drugs are compounded, dispensed, stored, or sold 297 if such locations are not otherwise defined in this subsection. 298 5. The term “Internet pharmacy” includes locations not 299 otherwise licensed or issued a permit under this chapter, within 300 or outside this state, which use the Internet to communicate 301 with or obtain information from consumers in this state and use 302 such communication or information to fill or refill 303 prescriptions or to dispense, distribute, or otherwise engage in 304 the practice of pharmacy in this state. Any act described in 305 this definition constitutes the practice of pharmacy as defined 306 in subsection (14)(13). 307 Section 3. Section 465.0065, Florida Statutes, is created 308 to read: 309 465.0065 Notices; form and service.—Each notice served by 310 the department pursuant to this chapter must be in writing and 311 must be delivered personally by an agent of the department or by 312 certified mail to the pharmacy permittee or licensee. If the 313 pharmacy permittee or licensee refuses to accept service or 314 evades service or if the agent is otherwise unable to carry out 315 service after due diligence, the department may post the notice 316 in a conspicuous place at the pharmacy or at the home or 317 business address for the licensee. 318 Section 4. Paragraphs (e) and (s) of subsection (1) of 319 section 465.016, Florida Statutes, are amended, and paragraph 320 (u) is added to that subsection, to read: 321 465.016 Disciplinary actions.— 322 (1) The following acts constitute grounds for denial of a 323 license or disciplinary action, as specified in s. 456.072(2): 324 (e) Violating chapter 499; 21 U.S.C. ss. 301-392, known as 325 the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et 326 seq., known as the Comprehensive Drug Abuse Prevention and 327 Control Act; or chapter 893 or rules adopted thereunder. 328 (s) Dispensing any medicinal drug based upon a 329 communication that purports to be a prescription as defined by 330 s. 465.003s.465.003(14)or s. 893.02 when the pharmacist knows 331 or has reason to believe that the purported prescription is not 332 based upon a valid practitioner-patient relationship. 333 (u) Misappropriating drugs, supplies, or equipment from a 334 pharmacy permittee. 335 Section 5. Paragraph (j) of subsection (5) of section 336 465.022, Florida Statutes, is amended, present subsections (10) 337 through (14) are renumbered as subsections (11) through (15), 338 respectively, present subsection (10) of that section is 339 amended, and a new subsection (10) is added to that section, to 340 read: 341 465.022 Pharmacies; general requirements; fees.— 342 (5) The department or board shall deny an application for a 343 pharmacy permit if the applicant or an affiliated person, 344 partner, officer, director, or prescription department manager 345 or consultant pharmacist of record of the applicant: 346 (j) Has dispensed any medicinal drug based upon a 347 communication that purports to be a prescription as defined by 348 s. 465.003s.465.003(14)or s. 893.02 when the pharmacist knows 349 or has reason to believe that the purported prescription is not 350 based upon a valid practitioner-patient relationship that 351 includes a documented patient evaluation, including history and 352 a physical examination adequate to establish the diagnosis for 353 which any drug is prescribed and any other requirement 354 established by board rule under chapter 458, chapter 459, 355 chapter 461, chapter 463, chapter 464, or chapter 466. 356 357 For felonies in which the defendant entered a plea of guilty or 358 nolo contendere in an agreement with the court to enter a 359 pretrial intervention or drug diversion program, the department 360 shall deny the application if upon final resolution of the case 361 the licensee has failed to successfully complete the program. 362 (10) The permittee shall commence pharmacy operations 363 within 180 days after issuance of the permit, or show good cause 364 to the department why pharmacy operations were not commenced. 365 Commencement of pharmacy operations includes, but is not limited 366 to, acts within the scope of the practice of pharmacy, ordering 367 or receiving drugs, and other similar activities. The board 368 shall establish rules regarding commencement of pharmacy 369 operations. 370 (11)(10)A pharmacy permittee shall be supervised by a 371 prescription department manager or consultant pharmacist of 372 record at all times. A permittee must notify the department, on 373 a form approved by the board, within 10 days after any change in 374 prescription department manager or consultant pharmacist of 375 record. 376 Section 6. Subsection (1) of section 465.023, Florida 377 Statutes, is amended to read: 378 465.023 Pharmacy permittee; disciplinary action.— 379 (1) The department or the board may revoke or suspend the 380 permit of any pharmacy permittee, and may fine, place on 381 probation, or otherwise discipline any pharmacy permittee if the 382 permittee, or any affiliated person, partner, officer, director, 383 or agent of the permittee, including a person fingerprinted 384 under s. 465.022(3), has: 385 (a) Obtained a permit by misrepresentation or fraud or 386 through an error of the department or the board; 387 (b) Attempted to procure, or has procured, a permit for any 388 other person by making, or causing to be made, any false 389 representation; 390 (c) Violated any of the requirements of this chapter or any 391 of the rules of the Board of Pharmacy; of chapter 499, known as 392 the “Florida Drug and Cosmetic Act”; of 21 U.S.C. ss. 301-392, 393 known as the “Federal Food, Drug, and Cosmetic Act”; of 21 394 U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse 395 Prevention and Control Act; or of chapter 893 or rules adopted 396 thereunder; 397 (d) Been convicted or found guilty, regardless of 398 adjudication, of a felony or any other crime involving moral 399 turpitude in any of the courts of this state, of any other 400 state, or of the United States; 401 (e) Been convicted or disciplined by a regulatory agency of 402 the Federal Government or a regulatory agency of another state 403 for any offense that would constitute a violation of this 404 chapter; 405 (f) Been convicted of, or entered a plea of guilty or nolo 406 contendere to, regardless of adjudication, a crime in any 407 jurisdiction which relates to the practice of, or the ability to 408 practice, the profession of pharmacy; 409 (g) Been convicted of, or entered a plea of guilty or nolo 410 contendere to, regardless of adjudication, a crime in any 411 jurisdiction which relates to health care fraud; or 412 (h) Dispensed any medicinal drug based upon a communication 413 that purports to be a prescription as defined by s. 465.003s.414465.003(14)or s. 893.02 when the pharmacist knows or has reason 415 to believe that the purported prescription is not based upon a 416 valid practitioner-patient relationship that includes a 417 documented patient evaluation, including history and a physical 418 examination adequate to establish the diagnosis for which any 419 drug is prescribed and any other requirement established by 420 board rule under chapter 458, chapter 459, chapter 461, chapter 421 463, chapter 464, or chapter 466. 422 Section 7. Section 465.1902, Florida Statutes, is created 423 to read: 424 465.1902 Preemption.—The regulation of pharmacies and 425 pharmacists is expressly preempted to the state. No local 426 ordinance, rule, or regulation shall be enacted or remain in 427 effect which regulates or attempts to regulate pharmacies or 428 pharmacists in subject matters regulated under this chapter, 429 including, but not limited to, licensure, discipline, pharmacy 430 permitting, and the dispensing of controlled substances. 431 Section 8. Paragraph (b) of subsection (2), paragraph (b) 432 of subsection (7), subsection (10), and paragraph (c) of 433 subsection (11) of section 893.055, Florida Statutes, are 434 amended to read: 435 893.055 Prescription drug monitoring program.— 436 (2) 437 (b) The department, when the direct support organization438receives at least $20,000 in nonstate moneys or the state439receives at least $20,000 in federal grants for the prescription440drug monitoring program,shall adopt rules as necessary 441 concerning the reporting, accessing the database, evaluation, 442 management, development, implementation, operation, security, 443 and storage of information within the system, including rules 444 for when patient advisory reports are provided to pharmacies and 445 prescribers. The patient advisory report shall be provided in 446 accordance with s. 893.13(7)(a)8. The department shall work with 447 the professional health care licensure boards, such as the Board 448 of Medicine, the Board of Osteopathic Medicine, and the Board of 449 Pharmacy; other appropriate organizations, such as the Florida 450 Pharmacy Association, the Florida Medical Association, the 451 Florida Retail Federation, and the Florida Osteopathic Medical 452 Association, including those relating to pain management; and 453 the Attorney General, the Department of Law Enforcement, and the 454 Agency for Health Care Administration to develop rules 455 appropriate for the prescription drug monitoring program. 456 (7) 457 (b) A pharmacy, prescriber, designated agent under the 458 supervision of a health care practitioner, or dispenser shall 459 have access to information in the prescription drug monitoring 460 program’s database which relates to a patient of that pharmacy, 461 prescriber, or dispenser in a manner established by the 462 department as needed for the purpose of reviewing the patient’s 463 controlled substance prescription history. Other access to the 464 program’s database shall be limited to the program’s manager and 465 to the designated program and support staff, who may act only at 466 the direction of the program manager or, in the absence of the 467 program manager, as authorized. Access by the program manager or 468 such designated staff is for prescription drug program 469 management only or for management of the program’s database and 470 its system in support of the requirements of this section and in 471 furtherance of the prescription drug monitoring program. 472 Confidential and exempt information in the database shall be 473 released only as provided in paragraph (c) and s. 893.0551. The 474 program manager, designated program and support staff who act at 475 the direction of or in the absence of the program manager, and 476 any individual who has similar access regarding the management 477 of the database from the prescription drug monitoring program 478 shall submit fingerprints to the department for background 479 screening. The department shall follow the procedure established 480 by the Department of Law Enforcement to request a statewide 481 criminal history record check and to request that the Department 482 of Law Enforcement forward the fingerprints to the Federal 483 Bureau of Investigation for a national criminal history record 484 check. 485 (10) All costs incurred by the department in administering 486 the prescription drug monitoring program shall be funded through 487 state funds, federal grants, or private funding applied for or 488 received by the state. The department may not commit funds for 489 the monitoring program without ensuring funding is available. 490The prescription drug monitoring program and the implementation491thereof are contingent upon receipt of the nonstate funding.The 492 department and state government shall cooperate with the direct 493 support organization established pursuant to subsection (11) in 494 seeking state funds, federal grant funds, other nonstate grant 495 funds, gifts, donations, or other private moneys for the 496 department ifso long asthe costs of doing so are not 497 considered material. Nonmaterial costs for this purpose include, 498 but are not limited to, the costs of mailing and personnel 499 assigned to research or apply for a grant. Notwithstanding the 500 exemptions to competitive-solicitation requirements under s. 501 287.057(3)(f), the department shall comply with the competitive 502 solicitation requirements under s. 287.057 for the procurement 503 of any goods or services required by this section.Funds504provided, directly or indirectly, by prescription drug505manufacturers may not be used to implement the program.506 (11) The department may establish a direct-support 507 organization that has a board consisting of at least five 508 members to provide assistance, funding, and promotional support 509 for the activities authorized for the prescription drug 510 monitoring program. 511 (c) The State Surgeon General shall appoint a board of 512 directors for the direct-support organization. Members of the 513 board shall serve at the pleasure of the State Surgeon General. 514 The State Surgeon General shall provide guidance to members of 515 the board to ensure that moneys received by the direct-support 516 organization are not received from inappropriate sources. 517 Inappropriate sources include, but are not limited to, donors, 518 grantors, persons,ororganizations, or pharmaceutical 519 companies, that may monetarily or substantively benefit from the 520 purchase of goods or services by the department in furtherance 521 of the prescription drug monitoring program. 522 Section 9. Paragraphs (d) and (e) of subsection (3) of 523 section 893.0551, Florida Statutes, are amended to read: 524 893.0551 Public records exemption for the prescription drug 525 monitoring program.— 526 (3) The department shall disclose such confidential and 527 exempt information to the following entities after using a 528 verification process to ensure the legitimacy of that person’s 529 or entity’s request for the information: 530 (d) A health care practitioner or a designated agent under 531 his or her supervision who certifies that the information is 532 necessary to provide medical treatment to a current patient in 533 accordance with ss. 893.05 and 893.055. 534 (e) A pharmacist or a designated agent under his or her 535 supervision who certifies that the requested information will be 536 used to dispense controlled substances to a current patient in 537 accordance with ss. 893.04 and 893.055. 538 Section 10. Section 893.0552, Florida Statutes, is created 539 to read: 540 893.0552 Preemption of regulation.— 541 (1) This section preempts to the state all regulation of 542 the licensure, activity, and operation of pain-management 543 clinics as defined in ss. 458.3265 and 459.0137 in the following 544 circumstances: 545 (a) The clinic is wholly owned and operated by a physician 546 who performs interventional pain procedures of the type 547 routinely billed using surgical codes, who has never been 548 suspended or revoked for prescribing a controlled substance in 549 Schedule II or Schedule III of s. 893.03 and drugs containing 550 Alprazolam in excessive or inappropriate quantities that are not 551 in the best interest of a patient, and who: 552 1. Has completed a fellowship in pain medicine which is 553 approved by the Accreditation Council for Graduate Medical 554 Education or the American Osteopathic Association; 555 2. Is board-certified in pain medicine by the American 556 Board of Pain Medicine, board-certified by the American Board of 557 Interventional Pain Physicians; or 558 3. Has a board certification or subcertification in pain 559 management or pain medicine by a specialty board approved by the 560 American Board of Medical Specialties or the American 561 Osteopathic Association. 562 (b) The clinic is wholly owned and operated by a physician 563 multispecialty practice if one or more board-eligible or board 564 certified medical specialists has one of the qualifications 565 specified in subparagraph (a)1., subparagraph (a)2., or 566 subparagraph (a)3., performs interventional pain procedures of 567 the type routinely billed using surgical codes, and has never 568 been suspended or revoked for prescribing a controlled substance 569 in Schedule II or Schedule III of s. 893.03 and drugs containing 570 Alprazolam in excessive or inappropriate quantities that are not 571 in the best interest of a patient. 572 (2) Notwithstanding subsection (1), the preemption does not 573 prohibit a local government or political subdivision from 574 enacting an ordinance regarding local business taxes adopted 575 pursuant to chapter 205 and land use development regulations 576 adopted pursuant to chapter 163. A pain-management clinic in 577 which the regulation of its licensure, activity, and operation 578 is preempted to the state pursuant to subsection (1) is a 579 permissible use in a land use or zoning category that permits 580 hospitals and other health care facilities or clinics as defined 581 in chapter 395 or s. 408.07. Upon the request of a local 582 government, a pain-management clinic must annually demonstrate 583 that it qualifies for preemption pursuant to subsection (1). 584 Section 11. Subsection (1) of section 409.9201, Florida 585 Statutes, is amended to read: 586 409.9201 Medicaid fraud.— 587 (1) As used in this section, the term: 588 (a) “Prescription drug” means any drug, including, but not 589 limited to, finished dosage forms or active ingredients that are 590 subject to, defined by, or described by s. 503(b) of the Federal 591 Food, Drug, and Cosmetic Act or by s. 465.003s.465.003(8), s. 592 499.003(46) or (53) or s. 499.007(13). 593 (b) “Value” means the amount billed to the Medicaid program 594 for the property dispensed or the market value of a legend drug 595 or goods or services at the time and place of the offense. If 596 the market value cannot be determined, the term means the 597 replacement cost of the legend drug or goods or services within 598 a reasonable time after the offense. 599 600 The value of individual items of the legend drugs or goods or 601 services involved in distinct transactions committed during a 602 single scheme or course of conduct, whether involving a single 603 person or several persons, may be aggregated when determining 604 the punishment for the offense. 605 Section 12. Paragraph (pp) of subsection (1) of section 606 458.331, Florida Statutes, is amended to read: 607 458.331 Grounds for disciplinary action; action by the 608 board and department.— 609 (1) The following acts constitute grounds for denial of a 610 license or disciplinary action, as specified in s. 456.072(2): 611 (pp) Applicable to a licensee who serves as the designated 612 physician of a pain-management clinic as defined in s. 458.3265 613 or s. 459.0137: 614 1. Registering a pain-management clinic through 615 misrepresentation or fraud; 616 2. Procuring, or attempting to procure, the registration of 617 a pain-management clinic for any other person by making or 618 causing to be made, any false representation; 619 3. Failing to comply with any requirement of chapter 499, 620 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the 621 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., 622 the Drug Abuse Prevention and Control Act; or chapter 893, the 623 Florida Comprehensive Drug Abuse Prevention and Control Act; 624 4. Being convicted or found guilty of, regardless of 625 adjudication to, a felony or any other crime involving moral 626 turpitude, fraud, dishonesty, or deceit in any jurisdiction of 627 the courts of this state, of any other state, or of the United 628 States; 629 5. Being convicted of, or disciplined by a regulatory 630 agency of the Federal Government or a regulatory agency of 631 another state for, any offense that would constitute a violation 632 of this chapter; 633 6. Being convicted of, or entering a plea of guilty or nolo 634 contendere to, regardless of adjudication, a crime in any 635 jurisdiction of the courts of this state, of any other state, or 636 of the United States which relates to the practice of, or the 637 ability to practice, a licensed health care profession; 638 7. Being convicted of, or entering a plea of guilty or nolo 639 contendere to, regardless of adjudication, a crime in any 640 jurisdiction of the courts of this state, of any other state, or 641 of the United States which relates to health care fraud; 642 8. Dispensing any medicinal drug based upon a communication 643 that purports to be a prescription as defined in s. 465.003s.644465.003(14)or s. 893.02 if the dispensing practitioner knows or 645 has reason to believe that the purported prescription is not 646 based upon a valid practitioner-patient relationship; or 647 9. Failing to timely notify the board of the date of his or 648 her termination from a pain-management clinic as required by s. 649 458.3265(2). 650 Section 13. Paragraph (rr) of subsection (1) of section 651 459.015, Florida Statutes, is amended to read: 652 459.015 Grounds for disciplinary action; action by the 653 board and department.— 654 (1) The following acts constitute grounds for denial of a 655 license or disciplinary action, as specified in s. 456.072(2): 656 (rr) Applicable to a licensee who serves as the designated 657 physician of a pain-management clinic as defined in s. 458.3265 658 or s. 459.0137: 659 1. Registering a pain-management clinic through 660 misrepresentation or fraud; 661 2. Procuring, or attempting to procure, the registration of 662 a pain-management clinic for any other person by making or 663 causing to be made, any false representation; 664 3. Failing to comply with any requirement of chapter 499, 665 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the 666 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., 667 the Drug Abuse Prevention and Control Act; or chapter 893, the 668 Florida Comprehensive Drug Abuse Prevention and Control Act; 669 4. Being convicted or found guilty of, regardless of 670 adjudication to, a felony or any other crime involving moral 671 turpitude, fraud, dishonesty, or deceit in any jurisdiction of 672 the courts of this state, of any other state, or of the United 673 States; 674 5. Being convicted of, or disciplined by a regulatory 675 agency of the Federal Government or a regulatory agency of 676 another state for, any offense that would constitute a violation 677 of this chapter; 678 6. Being convicted of, or entering a plea of guilty or nolo 679 contendere to, regardless of adjudication, a crime in any 680 jurisdiction of the courts of this state, of any other state, or 681 of the United States which relates to the practice of, or the 682 ability to practice, a licensed health care profession; 683 7. Being convicted of, or entering a plea of guilty or nolo 684 contendere to, regardless of adjudication, a crime in any 685 jurisdiction of the courts of this state, of any other state, or 686 of the United States which relates to health care fraud; 687 8. Dispensing any medicinal drug based upon a communication 688 that purports to be a prescription as defined in s. 465.003s.689465.003(14)or s. 893.02 if the dispensing practitioner knows or 690 has reason to believe that the purported prescription is not 691 based upon a valid practitioner-patient relationship; or 692 9. Failing to timely notify the board of the date of his or 693 her termination from a pain-management clinic as required by s. 694 459.0137(2). 695 Section 14. Subsection (1) of section 465.014, Florida 696 Statutes, is amended to read: 697 465.014 Pharmacy technician.— 698 (1) A person other than a licensed pharmacist or pharmacy 699 intern may not engage in the practice of the profession of 700 pharmacy, except that a licensed pharmacist may delegate to 701 pharmacy technicians who are registered pursuant to this section 702 those duties, tasks, and functions that do not fall within the 703 purview of s. 465.003s.465.003(13). All such delegated acts 704 shall be performed under the direct supervision of a licensed 705 pharmacist who shall be responsible for all such acts performed 706 by persons under his or her supervision. A pharmacy registered 707 technician, under the supervision of a pharmacist, may initiate 708 or receive communications with a practitioner or his or her 709 agent, on behalf of a patient, regarding refill authorization 710 requests. A licensed pharmacist may not supervise more than one 711 registered pharmacy technician unless otherwise permitted by the 712 guidelines adopted by the board. The board shall establish 713 guidelines to be followed by licensees or permittees in 714 determining the circumstances under which a licensed pharmacist 715 may supervise more than one but not more than three pharmacy 716 technicians. 717 Section 15. Paragraph (c) of subsection (2) of section 718 465.015, Florida Statutes, is amended to read: 719 465.015 Violations and penalties.— 720 (2) It is unlawful for any person: 721 (c) To sell or dispense drugs as defined in s. 465.003s.722465.003(8)without first being furnished with a prescription. 723 Section 16. Subsection (8) of section 465.0156, Florida 724 Statutes, is amended to read: 725 465.0156 Registration of nonresident pharmacies.— 726 (8) Notwithstanding s. 465.003s.465.003(10), for purposes 727 of this section, the registered pharmacy and the pharmacist 728 designated by the registered pharmacy as the prescription 729 department manager or the equivalent must be licensed in the 730 state of location in order to dispense into this state. 731 Section 17. Subsection (4) of section 465.0197, Florida 732 Statutes, is amended to read: 733 465.0197 Internet pharmacy permits.— 734 (4) Notwithstanding s. 465.003s.465.003(10), for purposes 735 of this section, the Internet pharmacy and the pharmacist 736 designated by the Internet pharmacy as the prescription 737 department manager or the equivalent must be licensed in the 738 state of location in order to dispense into this state. 739 Section 18. Section 465.1901, Florida Statutes, is amended 740 to read: 741 465.1901 Practice of orthotics and pedorthics.—The 742 provisions of chapter 468 relating to orthotics or pedorthics do 743 not apply to any licensed pharmacist or to any person acting 744 under the supervision of a licensed pharmacist. The practice of 745 orthotics or pedorthics by a pharmacist or any of the 746 pharmacist’s employees acting under the supervision of a 747 pharmacist shall be construed to be within the meaning of the 748 term “practice of the profession of pharmacy” as set forth in s. 749 465.003s.465.003(13), and shall be subject to regulation in 750 the same manner as any other pharmacy practice. The Board of 751 Pharmacy shall develop rules regarding the practice of orthotics 752 and pedorthics by a pharmacist. Any pharmacist or person under 753 the supervision of a pharmacist engaged in the practice of 754 orthotics or pedorthics is not precluded from continuing that 755 practice pending adoption of these rules. 756 Section 19. Subsection (43) of section 499.003, Florida 757 Statutes, is amended to read: 758 499.003 Definitions of terms used in this part.—As used in 759 this part, the term: 760 (43) “Prescription drug” means a prescription, medicinal, 761 or legend drug, including, but not limited to, finished dosage 762 forms or active pharmaceutical ingredients subject to, defined 763 by, or described by s. 503(b) of the Federal Food, Drug, and 764 Cosmetic Act or s. 465.003s.465.003(8), s. 499.007(13), or 765 subsection (11), subsection (46), or subsection (53), except 766 that an active pharmaceutical ingredient is a prescription drug 767 only if substantially all finished dosage forms in which it may 768 be lawfully dispensed or administered in this state are also 769 prescription drugs. 770 Section 20. Subsection (22) of section 893.02, Florida 771 Statutes, is amended to read: 772 893.02 Definitions.—The following words and phrases as used 773 in this chapter shall have the following meanings, unless the 774 context otherwise requires: 775 (22) “Prescription” means and includes an order for drugs 776 or medicinal supplies written, signed, or transmitted by word of 777 mouth, telephone, telegram, or other means of communication by a 778 duly licensed practitioner licensed by the laws of the state to 779 prescribe such drugs or medicinal supplies, issued in good faith 780 and in the course of professional practice, intended to be 781 filled, compounded, or dispensed by another person licensed by 782 the laws of the state to do so, and meeting the requirements of 783 s. 893.04. The term also includes an order for drugs or 784 medicinal supplies so transmitted or written by a physician, 785 dentist, veterinarian, or other practitioner licensed to 786 practice in a state other than Florida, but only if the 787 pharmacist called upon to fill such an order determines, in the 788 exercise of his or her professional judgment, that the order was 789 issued pursuant to a valid patient-physician relationship, that 790 it is authentic, and that the drugs or medicinal supplies so 791 ordered are considered necessary for the continuation of 792 treatment of a chronic or recurrent illness. However, if the 793 physician writing the prescription is not known to the 794 pharmacist, the pharmacist shall obtain proof to a reasonable 795 certainty of the validity of said prescription. A prescription 796 order for a controlled substance shall not be issued on the same 797 prescription blank with another prescription order for a 798 controlled substance which is named or described in a different 799 schedule, nor shall any prescription order for a controlled 800 substance be issued on the same prescription blank as a 801 prescription order for a medicinal drug, as defined in s. 802 465.003s.465.003(8), which does not fall within the definition 803 of a controlled substance as defined in this act. 804 Section 21. This act shall take effect July 1, 2013.