Bill Text: FL S0818 | 2011 | Regular Session | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Controlled Substances
Spectrum:
Status: (Introduced - Dead) 2011-05-06 - Read 3rd time -SJ 1092 [S0818 Detail]
Download: Florida-2011-S0818-Introduced.html
Bill Title: Controlled Substances
Spectrum:
Status: (Introduced - Dead) 2011-05-06 - Read 3rd time -SJ 1092 [S0818 Detail]
Download: Florida-2011-S0818-Introduced.html
Florida Senate - 2011 SB 818 By Senator Fasano 11-00210D-11 2011818__ 1 A bill to be entitled 2 An act relating to controlled substances; amending s. 3 400.9905, F.S.; redefining the terms “clinic” and 4 “portable equipment provider” within the Health Care 5 Clinic Act; amending s. 456.013, F.S.; authorizing 6 certain health care practitioners to complete a 7 continuing education course relating to the 8 prescription drug monitoring program; providing 9 requirements for the course; requiring the Department 10 of Health or a board that is authorized to exercise 11 regulatory or rulemaking functions within the 12 department to approve the course offered through a 13 facility licensed under ch. 395, F.S., under certain 14 circumstances; providing application of the course 15 requirements; requiring a board or the Department of 16 Health to adopt rules; amending s. 458.305, F.S.; 17 defining the term “dispensing physician” as it relates 18 to the practice of medicine in this state; prohibiting 19 certain persons from using titles or displaying signs 20 that would lead the public to believe that they engage 21 in the dispensing of controlled substances; 22 prohibiting certain persons, firms, or corporations 23 from using a trade name, sign, letter, or 24 advertisement that implies that the persons, firms, or 25 corporations are licensed or registered to dispense 26 prescription drugs; prohibiting certain persons, 27 firms, or corporations from holding themselves out to 28 the public as licensed or registered to dispense 29 controlled substances; prohibiting certain persons 30 from performing the functions of a dispensing 31 physician; providing penalties; amending s. 458.3191, 32 F.S.; revising the information in the physician survey 33 that is submitted by persons who apply for licensure 34 renewal as a physician under ch. 458 or ch. 459, F.S.; 35 amending s. 458.3192, F.S.; requiring the Department 36 of Health to provide nonidentifying information to the 37 prescription drug monitoring program’s Implementation 38 and Oversight Task Force regarding the number of 39 physicians that are registered with the prescription 40 drug monitoring program and that use the database from 41 the program in their practice; amending s. 458.3265, 42 F.S.; requiring a physician who works in a pain 43 management clinic to document the reason a 44 prescription for a certain dosage of a controlled 45 substance is within the proper standard of care; 46 creating a felony of the third-degree for a licensee 47 or other person who serves as the designated physician 48 of a pain-management clinic to register a pain 49 management clinic through misrepresentation or fraud; 50 amending s. 458.327, F.S.; providing additional 51 penalties; amending s. 458.331, F.S.; providing 52 additional grounds for disciplinary action by the 53 Board of Medicine; amending s. 459.003, F.S.; defining 54 the term “dispensing physician” as it relates to the 55 practice of osteopathic medicine in this state; 56 amending s. 459.013, F.S.; providing additional 57 penalties; amending s. 459.0137, F.S.; requiring an 58 osteopathic physician who works in a pain-management 59 clinic to document the reason a prescription for a 60 certain dosage of a controlled substance is within the 61 proper standard of care; creating a felony of the 62 third-degree for a licensee or other person who serves 63 as the designated physician of a pain-management 64 clinic to register a pain-management clinic through 65 misrepresentation or fraud; amending s. 459.015, F.S.; 66 providing additional grounds for disciplinary action 67 by the Board of Osteopathic Medicine; amending s. 68 465.015, F.S.; prohibiting certain persons from 69 knowingly failing to report to the local county 70 sheriff’s office and the Department of Law Enforcement 71 the commission of a felony involving a person who 72 acquires or obtains possession of a controlled 73 substance by misrepresentation, fraud, forgery, 74 deception, or subterfuge under certain conditions; 75 providing penalties; providing requirements for 76 reporting the commission of the felony that involves a 77 person who acquires or obtains possession of a 78 controlled substance by misrepresentation, fraud, 79 forgery, deception, or subterfuge; amending s. 80 465.0276, F.S.; requiring a practitioner to register 81 as a dispensing practitioner in order to dispense 82 controlled substances; amending s. 766.101, F.S.; 83 conforming a cross-reference; amending s. 810.02, 84 F.S.; redefining the offense of burglary to include 85 the theft of a controlled substance within a dwelling, 86 structure, or conveyance; amending s. 812.014, F.S.; 87 redefining the offense of theft to include the theft 88 of a controlled substance; creating s. 893.021, F.S.; 89 providing conditions in which a drug is considered 90 adulterated; providing that a physician is not 91 prevented from directing or prescribing a change to 92 the recognized manufactured recommendations for use of 93 any controlled substance in a patient under certain 94 circumstances; requiring a prescribing physician to 95 indicate any deviation of the recognized 96 manufacturer’s recommended use of a controlled 97 substance on the original prescription; requiring a 98 pharmacist or physician to indicate such deviation on 99 the label of the prescription upon dispensing; 100 amending s. 893.04, F.S.; revising the required 101 information that must appear on the face of a 102 prescription or written record of a controlled 103 substance before it is dispensed by a pharmacist; 104 amending s. 893.055, F.S.; requiring that the 105 prescription drug monitoring program comply with the 106 minimum requirements of the National All Schedules 107 Prescription Electronic Reporting Act; requiring the 108 Department of Health to establish a method to allow 109 corrections to the database of the prescription drug 110 monitoring program; requiring the number of refills 111 ordered and whether the drug was dispensed as a refill 112 or a first-time request to be included in the database 113 of the prescription drug monitoring program; revising 114 the number of days in which a dispensed controlled 115 substance must be reported to the department through 116 the prescription drug monitoring program; revising the 117 list of acts of dispensing or administering which are 118 exempt from reporting; requiring a pharmacy, 119 prescriber, practitioner, or dispenser to register 120 with the department by submitting a registering 121 document in order to have access to certain 122 information in the prescription drug monitoring 123 program’s database; requiring the department to 124 approve the registering document before granting 125 access to information in the prescription drug 126 monitoring program’s database; requiring criminal 127 background screening for those persons who have direct 128 access to the prescription drug monitoring program’s 129 database; authorizing the Attorney General to obtain 130 confidential and exempt information for Medicaid fraud 131 cases and Medicaid investigations; requiring certain 132 documentation to be provided to the program manager in 133 order to release confidential and exempt information 134 from the prescription drug monitoring program’s 135 database to a patient, legal guardian, or a designated 136 health care surrogate; authorizing the Agency for 137 Health Care Administration to obtain confidential and 138 exempt information from the prescription drug 139 monitoring program’s database for Medicaid fraud cases 140 and Medicaid investigations involving controlled 141 substances; deleting the provision that administrative 142 costs of the prescription drug monitoring program are 143 funded through federal grants and private sources; 144 requiring the State Surgeon General to enter into 145 reciprocal agreements for the sharing of information 146 in the prescription drug monitoring program with other 147 states that have a similar prescription drug 148 monitoring program; requiring the State Surgeon 149 General to annually review a reciprocal agreement to 150 determine its compatibility; providing requirements 151 for compatibility; prohibiting the sharing of certain 152 information; amending s. 893.0551, F.S.; authorizing 153 the Department of Health to disclose certain 154 confidential and exempt information in the 155 prescription drug monitoring program’s database under 156 certain circumstances involving reciprocal agreements 157 with other states; prohibiting the sharing of 158 information from the prescription drug monitoring 159 program’s database which is not for the purpose that 160 is statutorily authorized or according to the State 161 Surgeon General’s determination of compatibility; 162 amending s. 893.07, F.S.; requiring that a person 163 report to the Department of Law Enforcement and the 164 local sheriff’s office the theft or loss of a 165 controlled substance within a specified time; 166 providing penalties; providing legislative intent; 167 amending s. 893.13, F.S.; prohibiting a person from 168 obtaining or attempting to obtain from a practitioner 169 a controlled substance or a prescription for a 170 controlled substance by misrepresentation, fraud, 171 forgery, deception, subterfuge, or concealment of a 172 material fact; prohibiting a health care provider from 173 providing a controlled substance or a prescription for 174 a controlled substance by misrepresentation, fraud, 175 forgery, deception, subterfuge, or concealment of a 176 material fact; prohibiting a person from adulterating 177 a controlled substance for certain use without 178 authorization by a prescribing physician; authorizing 179 a law enforcement officer to seize as evidence the 180 adulteration or off-label use of a prescribed 181 controlled substance; providing that such adulterated 182 or off-label use of the controlled substance may be 183 returned to its owner only under certain conditions; 184 providing penalties; prohibiting a prescribing 185 practitioner from writing a prescription for a 186 controlled substance and authorizing or directing the 187 adulteration of the dispensed form of the controlled 188 substance for the purpose of ingestion by means that 189 is not medically necessary; amending s. 893.138, F.S.; 190 providing circumstances in which a pain-management 191 clinic may be declared a public nuisance; providing an 192 effective date. 193 194 Be It Enacted by the Legislature of the State of Florida: 195 196 Section 1. Subsections (4) and (7) of section 400.9905, 197 Florida Statutes, are amended to read: 198 400.9905 Definitions.— 199 (4) “Clinic” means an entity at which health care services 200 are provided to individuals and which tenders charges for 201 paymentreimbursementfor such services, including a mobile 202 clinic and a portable equipment provider. For purposes of this 203 part, the term does not include and the licensure requirements 204 of this part do not apply to: 205 (a) Entities licensed or registered by the state under 206 chapter 395; or entities licensed or registered by the state and 207 providing only health care services within the scope of services 208 authorized under their respective licenses granted under ss. 209 383.30-383.335, chapter 390, chapter 394, chapter 397, this 210 chapter except part X, chapter 429, chapter 463, chapter 465, 211 chapter 466, chapter 478, part I of chapter 483, chapter 484, or 212 chapter 651; end-stage renal disease providers authorized under 213 42 C.F.R. part 405, subpart U; or providers certified under 42 214 C.F.R. part 485, subpart B or subpart H; or any entity that 215 provides neonatal or pediatric hospital-based health care 216 services or other health care services by licensed practitioners 217 solely within a hospital licensed under chapter 395. 218 (b) Entities that own, directly or indirectly, entities 219 licensed or registered by the state pursuant to chapter 395; or 220 entities that own, directly or indirectly, entities licensed or 221 registered by the state and providing only health care services 222 within the scope of services authorized pursuant to their 223 respective licenses granted under ss. 383.30-383.335, chapter 224 390, chapter 394, chapter 397, this chapter except part X, 225 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, 226 part I of chapter 483, chapter 484, chapter 651; end-stage renal 227 disease providers authorized under 42 C.F.R. part 405, subpart 228 U; or providers certified under 42 C.F.R. part 485, subpart B or 229 subpart H; or any entity that provides neonatal or pediatric 230 hospital-based health care services by licensed practitioners 231 solely within a hospital licensed under chapter 395. 232 (c) Entities that are owned, directly or indirectly, by an 233 entity licensed or registered by the state pursuant to chapter 234 395; or entities that are owned, directly or indirectly, by an 235 entity licensed or registered by the state and providing only 236 health care services within the scope of services authorized 237 pursuant to their respective licenses granted under ss. 383.30 238 383.335, chapter 390, chapter 394, chapter 397, this chapter 239 except part X, chapter 429, chapter 463, chapter 465, chapter 240 466, chapter 478, part I of chapter 483, chapter 484, or chapter 241 651; end-stage renal disease providers authorized under 42 242 C.F.R. part 405, subpart U; or providers certified under 42 243 C.F.R. part 485, subpart B or subpart H; or any entity that 244 provides neonatal or pediatric hospital-based health care 245 services by licensed practitioners solely within a hospital 246 under chapter 395. 247 (d) Entities that are under common ownership, directly or 248 indirectly, with an entity licensed or registered by the state 249 pursuant to chapter 395; or entities that are under common 250 ownership, directly or indirectly, with an entity licensed or 251 registered by the state and providing only health care services 252 within the scope of services authorized pursuant to their 253 respective licenses granted under ss. 383.30-383.335, chapter 254 390, chapter 394, chapter 397, this chapter except part X, 255 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, 256 part I of chapter 483, chapter 484, or chapter 651; end-stage 257 renal disease providers authorized under 42 C.F.R. part 405, 258 subpart U; or providers certified under 42 C.F.R. part 485, 259 subpart B or subpart H; or any entity that provides neonatal or 260 pediatric hospital-based health care services by licensed 261 practitioners solely within a hospital licensed under chapter 262 395. 263 (e) An entity that is exempt from federal taxation under 26 264 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan 265 under 26 U.S.C. s. 409 that has a board of trustees not less 266 than two-thirds of which are Florida-licensed health care 267 practitioners and provides only physical therapy services under 268 physician orders, any community college or university clinic, 269 and any entity owned or operated by the federal or state 270 government, including agencies, subdivisions, or municipalities 271 thereof. 272 (f) A sole proprietorship, group practice, partnership, or 273 corporation that provides health care services by physicians 274 covered by s. 627.419, that is directly supervised by one or 275 more of such physicians, and that is wholly owned by one or more 276 of those physicians or by a physician and the spouse, parent, 277 child, or sibling of that physician. 278 (g) A sole proprietorship, group practice, partnership, or 279 corporation that provides health care services by licensed 280 health care practitioners under chapter 457, chapter 458, 281 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, 282 chapter 466, chapter 467, chapter 480, chapter 484, chapter 486, 283 chapter 490, chapter 491, or part I, part III, part X, part 284 XIII, or part XIV of chapter 468, or s. 464.012, which are 285 wholly owned by one or more licensed health care practitioners, 286 or the licensed health care practitioners set forth in this 287 paragraph and the spouse, parent, child, or sibling of a 288 licensed health care practitioner, so long as one of the owners 289 who is a licensed health care practitioner is supervising the 290 business activities and is legally responsible for the entity’s 291 compliance with all federal and state laws. However, a health 292 care practitioner may not supervise services beyond the scope of 293 the practitioner’s license, except that, for the purposes of 294 this part, a clinic owned by a licensee in s. 456.053(3)(b) that 295 provides only services authorized pursuant to s. 456.053(3)(b) 296 may be supervised by a licensee specified in s. 456.053(3)(b). 297 (h) Clinical facilities affiliated with an accredited 298 medical school at which training is provided for medical 299 students, residents, or fellows. 300 (i) Entities that provide only oncology or radiation 301 therapy services by physicians licensed under chapter 458 or 302 chapter 459 or entities that provide oncology or radiation 303 therapy services by physicians licensed under chapter 458 or 304 chapter 459 which are owned by a corporation whose shares are 305 publicly traded on a recognized stock exchange. 306 (j) Clinical facilities affiliated with a college of 307 chiropractic accredited by the Council on Chiropractic Education 308 at which training is provided for chiropractic students. 309 (k) Entities that provide licensed practitioners to staff 310 emergency departments or to deliver anesthesia services in 311 facilities licensed under chapter 395 and that derive at least 312 90 percent of their gross annual revenues from the provision of 313 such services. Entities claiming an exemption from licensure 314 under this paragraph must provide documentation demonstrating 315 compliance. 316 (l) Orthotic or prosthetic clinical facilities that are a 317 publicly traded corporation or that are wholly owned, directly 318 or indirectly, by a publicly traded corporation. As used in this 319 paragraph, a publicly traded corporation is a corporation that 320 issues securities traded on an exchange registered with the 321 United States Securities and Exchange Commission as a national 322 securities exchange. 323 (7) “Portable equipment provider” means an entity that 324 contracts with or employs persons to provide portable equipment 325 to multiple locations performing treatment or diagnostic testing 326 of individuals, that bills third-party payors for those327services,and that otherwise meets the definition of a clinic in 328 subsection (4). 329 Section 2. Subsection (7) of section 456.013, Florida 330 Statutes, is amended to read: 331 456.013 Department; general licensing provisions.— 332 (7)(a) The boards, or the department when there is no 333 board, shall require the completion of a 2-hour course relating 334 to prevention of medical errors as part of the licensure and 335 renewal process. The 2-hour course countsshall counttowards 336 the total number of continuing education hours required for the 337 profession. The board or department shall approve the course 338shall be approved by the board or department, as appropriate, 339 which mustand shallinclude a study of root-cause analysis, 340 error reduction and prevention, and patient safety. In addition, 341 the course approved by the Board of Medicine and the Board of 342 Osteopathic Medicine mustshallinclude information relating to 343 the five most misdiagnosed conditions during the previous 344 biennium, as determined by the board. If the course is being 345 offered by a facility licensed underpursuant tochapter 395 for 346 its employees, the board may approve up to 1 hour of the 2-hour 347 course to be specifically related to error reduction and 348 prevention methods used in that facility. 349 (b) As a condition of initial licensure and at each 350 subsequent license renewal, the boards, or the department if 351 there is no board, shall allow each practitioner licensed under 352 chapter 458, chapter 459, chapter 461, chapter 465, or chapter 353 466 whose lawful scope of practice authorizes the practitioner 354 to prescribe, administer, or dispense controlled substances to 355 complete a 3-hour continuing education course relating to the 356 prescription drug monitoring program. The course must include, 357 but need not be limited to: 358 1. The purpose of the prescription drug monitoring program. 359 2. The practitioners’ capabilities for improving the 360 standard of care for patients by using the prescription drug 361 monitoring program. 362 3. How the prescription drug monitoring program can help 363 practitioners detect doctor shopping. 364 4. The involvement of law enforcement personnel, the 365 Attorney General’s Medicaid Fraud Unit, and medical regulatory 366 investigators with the prescription drug monitoring program. 367 5. The procedures for registering for access to the 368 prescription drug monitoring program. 369 370 The course hours may be included in the total number of hours of 371 continuing education required by the profession and must be 372 approved by the board or by the department if there is no board. 373 The boards, or the department if there is no board, shall 374 approve the course offered through a facility licensed under 375 chapter 395 for its employees if the course is at least 3 hours 376 and covers the education requirements. 377 (c) The course requirements in paragraph (b) apply to each 378 licensee renewing his or her license on or after July 1, 2012, 379 and to each applicant approved for licensure on or after January 380 1, 2013. 381 (d) By October 1, 2011, the boards, or the department if 382 there is no board, shall adopt rules as necessary to administer 383 this subsection. 384 Section 3. Section 458.305, Florida Statutes, is amended to 385 read: 386 458.305 Definitions.—As used in this chapter: 387 (1) “Board” means the Board of Medicine. 388 (2) “Department” means the Department of Health. 389 (3) “Dispensing physician” means a physician who is 390 registered as a dispensing practitioner under s. 465.0276. 391 (4)(3)“Practice of medicine” means the diagnosis, 392 treatment, operation, or prescription for any human disease, 393 pain, injury, deformity, or other physical or mental condition. 394 (5)(4)“Physician” means a person who is licensed to 395 practice medicine in this state. 396 Section 4. Advertising of controlled substances by a 397 dispensing physician.— 398 (1)(a) A person, other than a dispensing physician licensed 399 under chapter 458 or chapter 459, Florida Statutes, may not use 400 the title “dispensing physician” or “dispenser” or otherwise 401 lead the public to believe that he or she is engaged in the 402 dispensing of controlled substances. 403 (b) A person, other than an owner of a: 404 1. Pain-management clinic registered under chapter 458 or 405 chapter 459, Florida Statutes; or 406 2. Health clinic licensed under chapter 400, Florida 407 Statutes, 408 409 may not display any sign or take any other action that would 410 lead the public to believe that such person is engaged in the 411 business of dispensing a controlled substance. Any advertisement 412 that states “dispensing onsite” or “onsite pharmacy” violates 413 this paragraph. This paragraph does not preclude a person who is 414 not licensed as a medical practitioner from owning a pain 415 management clinic. 416 (c) A person, firm, or corporation that is not licensed or 417 registered under chapter 458 or chapter 459, Florida Statutes, 418 may not: 419 1. Use in a trade name, sign, letter, or advertisement any 420 term, including “drug,” “pharmacy,” “onsite pharmacy,” 421 “dispensing,” “dispensing onsite,” “prescription drugs,” “Rx,” 422 or “apothecary,” which implies that the person, firm, or 423 corporation is licensed or registered to dispense prescription 424 drugs in this state. 425 2. Hold himself or herself out to the public as a person, 426 firm, or corporation that is licensed or registered to dispense 427 controlled substances in this state. 428 (2) A person who is not a dispensing physician under 429 chapter 458 or chapter 459, Florida Statutes, or who is not 430 otherwise exempt from the requirement to register as a 431 dispensing practitioner, may not perform the functions of a 432 dispensing physician. 433 (3) A person who violates paragraph (1)(a), paragraph 434 (1)(b), or subsection (2) commits a misdemeanor of the first 435 degree, punishable as provided in s. 775.082 or s. 775.083, Florida Statutes. 436 775.083, Florida Statutes. A person who violates paragraph (1)(c) commits 437 a felony of the third degree, punishable as provided in s. 438 775.082, s. 775.083, or s. 775.084, Florida Statutes. In any 439 warrant, information, or indictment, it is not necessary to 440 negate any exceptions, and the burden of any exception is upon 441 the defendant. 442 Section 5. Paragraph (a) of subsection (1) of section 443 458.3191, Florida Statutes, is amended to read: 444 458.3191 Physician survey.— 445 (1) Each person who applies for licensure renewal as a 446 physician under this chapter or chapter 459 must, in conjunction 447 with the renewal of such license under procedures adopted by the 448 Department of Health and in addition to any other information 449 that may be required from the applicant, furnish the following 450 to the Department of Health in a physician survey: 451 (a) Licensee information, including, but not limited to: 452 1. Frequency and geographic location of practice within the 453 state. 454 2. Practice setting. 455 3. Percentage of time spent in direct patient care. 456 4. Anticipated change to license or practice status. 457 5. Areas of specialty or certification. 458 6. Whether the department has ever approved or denied the 459 physician’s registration for access to a patient’s information 460 in the prescription drug monitoring program’s database. 461 7. Whether the physician uses the prescription drug 462 monitoring program with patients in his or her medical practice. 463 Section 6. Subsection (3) is added to section 458.3192, 464 Florida Statutes, to read: 465 458.3192 Analysis of survey results; report.— 466 (3) By November 1 each year, the Department of Health shall 467 provide nonidentifying information to the prescription drug 468 monitoring program’s Implementation and Oversight Task Force 469 regarding the number of physicians who are registered with the 470 prescription drug monitoring program and who also use the 471 database from the prescription drug monitoring program for their 472 patients in their medical practice. 473 Section 7. Paragraph (c) of subsection (2) of section 474 458.3265, Florida Statutes, is amended, and paragraph (f) is 475 added to subsection (5) of that section, to read: 476 458.3265 Pain-management clinics.— 477 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities 478 apply to any physician who provides professional services in a 479 pain-management clinic that is required to be registered in 480 subsection (1). 481 (c) A physician must perform a physical examination of a 482 patient on the same day that he or she dispenses or prescribes a 483 controlled substance to a patient at a pain-management clinic. 484 If the physician prescribes or dispenses more than a 72-hour 485 dose of controlled substances for the treatment of chronic 486 nonmalignant pain, the physician must document in the patient’s 487 record the reason such dosage is within the standard of carefor488prescribing or dispensing that quantity. 489 (5) PENALTIES; ENFORCEMENT.— 490 (f) A licensee or other person who serves as the designated 491 physician of a pain-management clinic as defined in this section 492 or s. 459.0137 and registers a pain-management clinic through 493 misrepresentation or fraud or procures or attempts to procure 494 the registration of a pain-management clinic for any other 495 person by making or causing to be made any false or fraudulent 496 representation commits a felony of the third degree, punishable 497 as provided in s. 775.082, s. 775.083, or s. 775.084. 498 Section 8. Paragraphs (f) and (g) are added to subsection 499 (1), paragraphs (g) and (h) are added to subsection (2), and 500 subsection (3) is added to section 458.327, Florida Statutes, to 501 read: 502 458.327 Penalty for violations.— 503 (1) Each of the following acts constitutes a felony of the 504 third degree, punishable as provided in s. 775.082, s. 775.083, 505 or s. 775.084: 506 (f) Failing to perform a physical examination of a patient 507 on the same day that the treating physician dispenses or 508 prescribes a controlled substance to the patient at a pain 509 management clinic occurring three or more times within a 6-month 510 period, or failing to perform a physical examination on three or 511 more different patients on the same day that the treating 512 physician dispenses or prescribes a controlled substance to each 513 patient at a pain-management clinic within a 6-month period. 514 (g) Prescribing or dispensing in excess of a 72-hour dose 515 of controlled substances for the treatment of chronic 516 nonmalignant pain of a patient occurring three or more times 517 within a 6-month period without documenting in the patient’s 518 record the reason that such dosage is within the standard of 519 care. 520 (2) Each of the following acts constitutes a misdemeanor of 521 the first degree, punishable as provided in s. 775.082 or s. 522 775.083: 523 (g) Failing to perform a physical examination of a patient 524 on the same day that the treating physician dispenses or 525 prescribes a controlled substance to the patient at a pain 526 management clinic two or more times in a 6-month period, or 527 failing to perform a physical examination on two or more 528 different patients on the same day that the treating physician 529 dispenses or prescribes a controlled substance to each patient 530 at a pain-management clinic within a 6-month period. 531 (h) Prescribing or dispensing in excess of a 72-hour dose 532 of controlled substances for the treatment of chronic 533 nonmalignant pain of a patient occurring two or more times 534 within a 6-month period without documenting in the patient’s 535 record the reason that such dosage is within the standard of 536 care. 537 (3) Each of the following acts constitutes a misdemeanor of 538 the second degree, punishable as provided in s. 775.082 or s. 539 775.083: 540 (a) A first offense of failing to perform a physical 541 examination of a patient on the same day that the treating 542 physician dispenses or prescribes a controlled substance to the 543 patient at a pain-management clinic. 544 (b) A first offense of failing to document in a patient’s 545 record the reason that such dosage is within the standard of 546 care for prescribing or dispensing in excess of a 72-hour dose 547 of controlled substances for the treatment of chronic 548 nonmalignant pain. 549 Section 9. Subsection (11) is added to section 458.331, 550 Florida Statutes, to read: 551 458.331 Grounds for disciplinary action; action by the 552 board and department.— 553 (11) Notwithstanding subsection (2), upon finding that a 554 physician has prescribed or dispensed, or caused to be 555 prescribed or dispensed, a controlled substance in a pain 556 management clinic in a manner that violates the standard of 557 practice as set forth in chapter 458 or rules adopted pursuant 558 to chapter 458, the board shall, at a minimum, suspend the 559 physician’s license for at least 6 months and impose a fine of 560 at least $10,000 per count. Repeated violations shall result in 561 increased penalties. 562 Section 10. Present subsections (3), (4), and (5) of 563 section 459.003, Florida Statutes, are redesignated as 564 subsections (4), (5), and (6), respectively, and a new 565 subsection (3) is added to that section, to read: 566 459.003 Definitions.—As used in this chapter: 567 (3) “Dispensing physician” means an osteopathic physician 568 who is registered as a dispensing practitioner under s. 569 465.0276. 570 Section 11. Paragraphs (f) and (g) are added to subsection 571 (1), paragraphs (e) and (f) are added to subsection (2), and 572 paragraphs (d) and (e) are added to subsection (3) of section 573 459.013, Florida Statutes, to read: 574 459.013 Penalty for violations.— 575 (1) Each of the following acts constitutes a felony of the 576 third degree, punishable as provided in s. 775.082, s. 775.083, 577 or s. 775.084: 578 (f) Failing to perform a physical examination of a patient 579 on the same day that the osteopathic physician dispenses or 580 prescribes a controlled substance to the patient at a pain 581 management clinic occurring three or more times within a 6-month 582 period, or failing to perform a physical examination on three or 583 more different patients on the same day that the osteopathic 584 physician dispenses or prescribes a controlled substance to each 585 patient at a pain-management clinic within a 6-month period. 586 (g) Prescribing or dispensing in excess of a 72-hour dose 587 of controlled substances for the treatment of chronic 588 nonmalignant pain of a patient occurring three or more times 589 within a 6-month period without documenting in the patient’s 590 record the reason that such dosage is within the standard of 591 care. 592 (2) Each of the following acts constitutes a misdemeanor of 593 the first degree, punishable as provided in s. 775.082 or s. 594 775.083: 595 (e) Failing to perform a physical examination of a patient 596 on the same day that the osteopathic physician dispenses or 597 prescribes a controlled substance to the patient at a pain 598 management clinic occurring two or more times within a 6-month 599 period, or failing to perform a physical examination on two or 600 more different patients on the same day that the osteopathic 601 physician dispenses or prescribes a controlled substance to each 602 patient at a pain-management clinic within a 6-month period. 603 (f) Prescribing or dispensing in excess of a 72-hour dose 604 of controlled substances for the treatment of chronic 605 nonmalignant pain of a patient occurring two or more times 606 within a 6-month period without documenting in the patient’s 607 record the reason that such dosage is within the standard of 608 care. 609 (3) Each of the following constitutes a misdemeanor of the 610 second degree, punishable as provided in s. 775.082 or s. 611 775.083: 612 (d) A first offense of failing to perform a physical 613 examination of a patient on the same day that the osteopathic 614 physician dispenses or prescribes a controlled substance to the 615 patient at a pain-management clinic. 616 (e) A first offense of failing to document in a patient’s 617 record the reason that such dosage is within the standard of 618 care for prescribing or dispensing in excess of a 72-hour dose 619 of controlled substances for the treatment of chronic 620 nonmalignant pain. 621 Section 12. Paragraph (c) of subsection (2) of section 622 459.0137, Florida Statutes, is amended, and a new paragraph (f) 623 is added to subsection (5) of that section, to read: 624 459.0137 Pain-management clinics.— 625 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities 626 apply to any osteopathic physician who provides professional 627 services in a pain-management clinic that is required to be 628 registered in subsection (1). 629 (c) An osteopathic physician must perform a physical 630 examination of a patient on the same day that he or she 631 dispenses or prescribes a controlled substance to a patient at a 632 pain-management clinic. If the osteopathic physician prescribes 633 or dispenses more than a 72-hour dose of controlled substances 634 for the treatment of chronic nonmalignant pain, the osteopathic 635 physician must document in the patient’s record the reason such 636 dosage is within the standard of carefor prescribing or637dispensing that quantity. 638 (5) PENALTIES; ENFORCEMENT.— 639 (f) A licensee or other person who serves as the designated 640 physician of a pain-management clinic as defined in s. 458.3265 641 or s. 459.0137 and registers a pain-management clinic through 642 misrepresentation or fraud or procures or attempts to procure 643 the registration of a pain-management clinic for any other 644 person by making or causing to be made any false or fraudulent 645 representation commits a felony of the third degree, punishable 646 as provided in s. 775.082, s. 775.083, or s. 775.084. 647 Section 13. Subsection (11) is added to section 459.015, 648 Florida Statutes, to read: 649 459.015 Grounds for disciplinary action; action by the 650 board and department.— 651 (11) Notwithstanding subsection (2), upon finding that an 652 osteopathic physician has prescribed or dispensed, or caused to 653 be prescribed or dispensed, a controlled substance in a pain 654 management clinic in a manner that violates the standard of 655 practice as set forth in chapter 459 or rules adopted pursuant 656 to chapter 459, the board shall, at a minimum, suspend the 657 osteopathic physician’s license for at least 6 months and impose 658 a fine of at least $10,000 per count. Repeated violations shall 659 result in increased penalties. 660 Section 14. Subsection (5) is added to section 465.015, 661 Florida Statutes, to read: 662 465.015 Violations and penalties.— 663 (5)1. A licensed pharmacist, pharmacy technician, or any 664 person working under the direction or supervision of a 665 pharmacist or pharmacy technician, may not knowingly fail to 666 timely report to the Department of Law Enforcement and the local 667 county sheriff’s office the name of any person who obtains or 668 attempts to obtain a substance controlled by s. 893.03 which the 669 pharmacist, pharmacy intern, or other person employed by or at a 670 pharmacy knows or reasonably should have known was obtained or 671 attempted to be obtained from the pharmacy through any 672 fraudulent method or representation. A pharmacist, pharmacy 673 intern, or other person employed by or at a pharmacy who fails 674 to make such a report within 24 hours after learning of the 675 fraud or attempted fraud commits a misdemeanor of the first 676 degree, punishable as provided in s. 775.082 or s. 775.083. 677 2. A sufficient report of the fraudulent obtaining of or 678 attempt to obtain a controlled substance under this section must 679 contain, at a minimum, a copy of the prescription used or 680 presented and a narrative, including all information available 681 to the pharmacy regarding: 682 a. The transaction, such as the name and telephone number 683 of the prescribing physician; 684 b. The name, description, and any personal identification 685 information pertaining to the person presenting the 686 prescription; and 687 c. All other material information, such as photographic or 688 video surveillance of the transaction. 689 Section 15. Subsection (6) is added to section 465.0276, 690 Florida Statutes, to read: 691 465.0276 Dispensing practitioner.— 692 (6) In order to dispense a controlled substance listed in 693 Schedule II, Schedule III, Schedule IV, or Schedule V in s. 694 893.03, a practitioner authorized by law to prescribe a 695 controlled substance shall register with the Board of Pharmacy 696 as a dispensing practitioner who dispenses controlled substances 697 and pay a fee not to exceed $100. The department shall adopt 698 rules establishing procedures for renewal of the registration 699 every 4 years. 700 Section 16. Paragraph (a) of subsection (1) of section 701 766.101, Florida Statutes, is amended to read: 702 766.101 Medical review committee, immunity from liability.— 703 (1) As used in this section: 704 (a) The term “medical review committee” or “committee” 705 means: 706 1.a. A committee of a hospital or ambulatory surgical 707 center licensed under chapter 395 or a health maintenance 708 organization certificated under part I of chapter 641, 709 b. A committee of a physician-hospital organization, a 710 provider-sponsored organization, or an integrated delivery 711 system, 712 c. A committee of a state or local professional society of 713 health care providers, 714 d. A committee of a medical staff of a licensed hospital or 715 nursing home, provided the medical staff operates pursuant to 716 written bylaws that have been approved by the governing board of 717 the hospital or nursing home, 718 e. A committee of the Department of Corrections or the 719 Correctional Medical Authority as created under s. 945.602, or 720 employees, agents, or consultants of either the department or 721 the authority or both, 722 f. A committee of a professional service corporation formed 723 under chapter 621 or a corporation organized under chapter 607 724 or chapter 617, which is formed and operated for the practice of 725 medicine as defined in s. 458.305(4)s.458.305(3), and which 726 has at least 25 health care providers who routinely provide 727 health care services directly to patients, 728 g. A committee of the Department of Children and Family 729 Services which includes employees, agents, or consultants to the 730 department as deemed necessary to provide peer review, 731 utilization review, and mortality review of treatment services 732 provided pursuant to chapters 394, 397, and 916, 733 h. A committee of a mental health treatment facility 734 licensed under chapter 394 or a community mental health center 735 as defined in s. 394.907, provided the quality assurance program 736 operates pursuant to the guidelines which have been approved by 737 the governing board of the agency, 738 i. A committee of a substance abuse treatment and education 739 prevention program licensed under chapter 397 provided the 740 quality assurance program operates pursuant to the guidelines 741 which have been approved by the governing board of the agency, 742 j. A peer review or utilization review committee organized 743 under chapter 440, 744 k. A committee of the Department of Health, a county health 745 department, healthy start coalition, or certified rural health 746 network, when reviewing quality of care, or employees of these 747 entities when reviewing mortality records, or 748 l. A continuous quality improvement committee of a pharmacy 749 licensed pursuant to chapter 465, 750 751 which committee is formed to evaluate and improve the quality of 752 health care rendered by providers of health service, to 753 determine that health services rendered were professionally 754 indicated or were performed in compliance with the applicable 755 standard of care, or that the cost of health care rendered was 756 considered reasonable by the providers of professional health 757 services in the area; or 758 2. A committee of an insurer, self-insurer, or joint 759 underwriting association of medical malpractice insurance, or 760 other persons conducting review under s. 766.106. 761 Section 17. Subsection (3) of section 810.02, Florida 762 Statutes, is amended to read: 763 810.02 Burglary.— 764 (3) Burglary is a felony of the second degree, punishable 765 as provided in s. 775.082, s. 775.083, or s. 775.084, if, in the 766 course of committing the offense, the offender does not make an 767 assault or battery and is not and does not become armed with a 768 dangerous weapon or explosive, and the offender enters or 769 remains in a: 770 (a) Dwelling, and there is another person in the dwelling 771 at the time the offender enters or remains; 772 (b) Dwelling, and there is not another person in the 773 dwelling at the time the offender enters or remains; 774 (c) Structure, and there is another person in the structure 775 at the time the offender enters or remains; 776 (d) Conveyance, and there is another person in the 777 conveyance at the time the offender enters or remains;or778 (e) Authorized emergency vehicle, as defined in s. 316.003; 779 or.780 (f) Dwelling, structure, or conveyance when the offense 781 intended to be committed is theft of a substance controlled by 782 s. 893.03. Notwithstanding any contrary provisions of law, 783 separate judgments and sentences for burglary with the intent to 784 commit theft of a controlled substance under this paragraph and 785 for any applicable offense for possession of a controlled 786 substance under s. 893.13, or an offense for trafficking in a 787 controlled substance under s. 893.135, may be imposed if all 788 such offenses involve the same amount or amounts of a controlled 789 substance. 790 791 However, if the burglary is committed within a county that is 792 subject to a state of emergency declared by the Governor under 793 chapter 252 after the declaration of emergency is made and the 794 perpetration of the burglary is facilitated by conditions 795 arising from the emergency, the burglary is a felony of the 796 first degree, punishable as provided in s. 775.082, s. 775.083, 797 or s. 775.084. As used in this subsection, the term “conditions 798 arising from the emergency” means civil unrest, power outages, 799 curfews, voluntary or mandatory evacuations, or a reduction in 800 the presence of or response time for first responders or 801 homeland security personnel. A person arrested for committing a 802 burglary within a county that is subject to such a state of 803 emergency may not be released until the person appears before a 804 committing magistrate at a first appearance hearing. For 805 purposes of sentencing under chapter 921, a felony offense that 806 is reclassified under this subsection is ranked one level above 807 the ranking under s. 921.0022 or s. 921.0023 of the offense 808 committed. 809 Section 18. Paragraph (c) of subsection (2) of section 810 812.014, Florida Statutes, is amended to read: 811 812.014 Theft.— 812 (2) 813 (c) It is grand theft of the third degree and a felony of 814 the third degree, punishable as provided in s. 775.082, s. 815 775.083, or s. 775.084, if the property stolen is: 816 1. Valued at $300 or more, but less than $5,000. 817 2. Valued at $5,000 or more, but less than $10,000. 818 3. Valued at $10,000 or more, but less than $20,000. 819 4. A will, codicil, or other testamentary instrument. 820 5. A firearm. 821 6. A motor vehicle, except as provided in paragraph (a). 822 7. Any commercially farmed animal, including any animal of 823 the equine, bovine, or swine class, or other grazing animal, and 824 including aquaculture species raised at a certified aquaculture 825 facility. If the property stolen is aquaculture species raised 826 at a certified aquaculture facility, then a $10,000 fine shall 827 be imposed. 828 8. Any fire extinguisher. 829 9. Any amount of citrus fruit consisting of 2,000 or more 830 individual pieces of fruit. 831 10. Taken from a designated construction site identified by 832 the posting of a sign as provided for in s. 810.09(2)(d). 833 11. Any stop sign. 834 12. Anhydrous ammonia. 835 13. Any amount of a substance controlled by s. 893.03. 836 Notwithstanding any contrary provisions of law, separate 837 judgments and sentences for theft of a controlled substance 838 under this subparagraph, and for any applicable offense for 839 possession of a controlled substance under s. 893.13, or an 840 offense for trafficking in a controlled substance under s. 841 893.135 may be imposed if all such offenses involve the same 842 amount or amounts of controlled substance. 843 844 However, if the property is stolen within a county that is 845 subject to a state of emergency declared by the Governor under 846 chapter 252, the property is stolen after the declaration of 847 emergency is made, and the perpetration of the theft is 848 facilitated by conditions arising from the emergency, the 849 offender commits a felony of the second degree, punishable as 850 provided in s. 775.082, s. 775.083, or s. 775.084, if the 851 property is valued at $5,000 or more, but less than $10,000, as 852 provided under subparagraph 2., or if the property is valued at 853 $10,000 or more, but less than $20,000, as provided under 854 subparagraph 3. As used in this paragraph, the term “conditions 855 arising from the emergency” means civil unrest, power outages, 856 curfews, voluntary or mandatory evacuations, or a reduction in 857 the presence of or the response time for first responders or 858 homeland security personnel. For purposes of sentencing under 859 chapter 921, a felony offense that is reclassified under this 860 paragraph is ranked one level above the ranking under s. 861 921.0022 or s. 921.0023 of the offense committed. 862 Section 19. Section 893.021, Florida Statutes, is created 863 to read: 864 893.021 Adulterated drug.—As used in this chapter, a drug 865 is adulterated if: 866 (1) It is a controlled substance approved by the Federal 867 Drug Administration, or on the list of controlled substances 868 pursuant to s. 893.03, and its manufactured form has been 869 altered by breaking, crushing, dissolving, or combining with an 870 additive substance that may cause a difference in the strength, 871 quality, or purity of the drug which could render the substance 872 injurious to a person’s health. 873 (2) It is a controlled substance that: 874 (a) Has been produced, prepared, packed, and marketed for 875 oral consumption by the manufacturer; and 876 (b) Has had any change to its integrity or composition for 877 off-label use by means of inhalation, injection, or any other 878 form of ingestion not in accordance with the manufacturer’s 879 recommended use, and such off-label use has not been previously 880 directed and approved by the prescribing physician. 881 882 A physician is not prevented from directing or prescribing a 883 change to the recognized manufactured recommendations for use in 884 a patient who presents a medical need for such a requirement 885 change of any controlled substance. The prescribing physician 886 shall clearly indicate any deviation of the recognized 887 manufacturer’s recommended use of a controlled substance on the 888 original prescription, and the licensed pharmacist shall clearly 889 indicate such deviation on the label of the prescription upon 890 dispensing the controlled substance. 891 Section 20. Paragraphs (c), (d), and (e) of subsection (1) 892 of section 893.04, Florida Statutes, are amended to read: 893 893.04 Pharmacist and practitioner.— 894 (1) A pharmacist, in good faith and in the course of 895 professional practice only, may dispense controlled substances 896 upon a written or oral prescription of a practitioner, under the 897 following conditions: 898 (c) The following information mustThere shallappear on 899 the face of the prescription or written record of athereof for900thecontrolled substancethe following information: 901 1. The full name and address of the person for whom, or the 902 owner of the animal for which, the controlled substance is 903 dispensed. 904 2. The full name and address of the prescribing 905 practitioner and the practitioner’s federal controlled substance 906 registry number shall be printed thereon. 907 3. If the prescription is for an animal, the species of 908 animal for which the controlled substance is prescribed. 909 4. The name of the controlled substance prescribed and the 910 strength, quantity, and directions for use thereof. The 911 directions for use must specify the authorization by the 912 physician, any instructions requiring the adulteration of the 913 dispensed form of the medication, and the medical necessity for 914 the adulteration in accordance with s. 893.021. 915 5. The number of the prescription, as recorded in the 916 prescription files of the pharmacy in which it is filled. 917 6. The initials of the pharmacist filling the prescription 918 and the date filled. 919 (d) The prescription mustshallbe retained on file by the 920 proprietor of the pharmacy in which it is filled for a period of 921 2 years. 922 (e) A label bearing the following information must be 923 affixed to the original container in which a controlled 924 substance is delivered asupona prescription or authorized 925 refillthereof, as hereinafter provided, there shall be a label926bearing the following information: 927 1. The name and address of the pharmacy from which such 928 controlled substance was dispensed. 929 2. The date on which the prescription for such controlled 930 substance was filled. 931 3. The number of such prescription, as recorded in the 932 prescription files of the pharmacy in which it is filled. 933 4. The name of the prescribing practitioner. 934 5. The name of the patient for whom, or of the owner and 935 species of the animal for which, the controlled substance is 936 prescribed. 937 6. The directions for the use of the controlled substance 938 prescribed in the prescription. 939 7. A clear, concise warning that it is a crime to transfer 940 the controlled substance to any person other than the patient 941 for whom prescribed. 942 Section 21. Section 893.055, Florida Statutes, is amended 943 to read: 944 893.055 Prescription drug monitoring program.— 945 (1) As used in this section, the term: 946 (a) “Patient advisory report” or “advisory report” means 947 information provided by the department in writing, or as 948 determined by the department, to a prescriber, dispenser, 949 pharmacy, or patient concerning the dispensing of controlled 950 substances. All advisory reports are for informational purposes 951 only and impose no obligations of any nature or any legal duty 952 on a prescriber, dispenser, pharmacy, or patient. The patient 953 advisory report shall be provided in accordance with s. 954 893.13(7)(a)8. The advisory reports issued by the department are 955 not subject to discovery or introduction into evidence in any 956 civil or administrative action against a prescriber, dispenser, 957 pharmacy, or patient arising out of matters that are the subject 958 of the report; and a person who participates in preparing, 959 reviewing, issuing, or any other activity related to an advisory 960 report may not be permitted or required to testify in any such 961 civil action as to any findings, recommendations, evaluations, 962 opinions, or other actions taken in connection with preparing, 963 reviewing, or issuing such a report. 964 (b) “Controlled substance” means a controlled substance 965 listed in Schedule II, Schedule III, or Schedule IV in s. 966 893.03. 967 (c) “Dispenser” means a pharmacy, dispensing pharmacist, or 968 dispensing health care practitioner. 969 (d) “Health care practitioner” or “practitioner” means any 970 practitioner who is subject to licensure or regulation by the 971 department under chapter 458, chapter 459, chapter 461, chapter 972 462, chapter 464, chapter 465, or chapter 466. 973 (e) “Health care regulatory board” means any board for a 974 practitioner or health care practitioner who is licensed or 975 regulated by the department. 976 (f) “Pharmacy” means any pharmacy that is subject to 977 licensure or regulation by the department under chapter 465 and 978 that dispenses or delivers a controlled substance to an 979 individual or address in this state. 980 (g) “Prescriber” means a prescribing physician, prescribing 981 practitioner, or other prescribing health care practitioner. 982 (h) “Active investigation” means an investigation that is 983 being conducted with a reasonable, good faith belief that it 984 could lead to the filing of administrative, civil, or criminal 985 proceedings, or that is ongoing and continuing and for which 986 there is a reasonable, good faith anticipation of securing an 987 arrest or prosecution in the foreseeable future. 988 (i) “Law enforcement agency” means the Department of Law 989 Enforcement, a Florida sheriff’s department, a Florida police 990 department, or a law enforcement agency of the Federal 991 Government which enforces the laws of this state or the United 992 States relating to controlled substances, and which its agents 993 and officers are empowered by law to conduct criminal 994 investigations and make arrests. 995 (j) “Program manager” means an employee of or a person 996 contracted by the Department of Health who is designated to 997 ensure the integrity of the prescription drug monitoring program 998 in accordance with the requirements established in paragraphs 999 (2)(a) and (b). 1000 (2)(a) By December 1, 2010, the department shall design and 1001 establish a comprehensive electronic database system that has 1002 controlled substance prescriptions provided to it and that 1003 provides prescription information to a patient’s health care 1004 practitioner and pharmacist who inform the department that they 1005 wish the patient advisory report provided to them. Otherwise, 1006 the patient advisory report will not be sent to the 1007 practitioner, pharmacy, or pharmacist. The system shall be 1008 designed to provide information regarding dispensed 1009 prescriptions of controlled substances and shall not infringe 1010 upon the legitimate prescribing or dispensing of a controlled 1011 substance by a prescriber or dispenser acting in good faith and 1012 in the course of professional practice. The system shall be 1013 consistent with standards of the American Society for Automation 1014 in Pharmacy (ASAP). The electronic system shall also comply with 1015 the Health Insurance Portability and Accountability Act (HIPAA) 1016 as it pertains to protected health information (PHI), electronic 1017 protected health information (EPHI), the National All Schedules 1018 Prescription Electronic Reporting (NASPER) Act’s minimum 1019 requirements for authentication of a practitioner who requests 1020 information in the prescription drug monitoring program database 1021 and certification of the purpose for which information is 1022 requested, and all other relevant state and federal privacy and 1023 security laws and regulations. The department shall establish 1024 policies and procedures as appropriate regarding the reporting, 1025 accessing the database, evaluation, management, development, 1026 implementation, operation, storage, and security of information 1027 within the system. The reporting of prescribed controlled 1028 substances shall include a dispensing transaction with a 1029 dispenser pursuant to chapter 465 or through a dispensing 1030 transaction to an individual or address in this state with a 1031 pharmacy that is not located in this state but that is otherwise 1032 subject to the jurisdiction of this state as to that dispensing 1033 transaction. The reporting of patient advisory reports refers 1034 only to reports to patients, pharmacies, and practitioners. 1035 Separate reports that contain patient prescription history 1036 information and that are not patient advisory reports are 1037 provided to persons and entities as authorized in paragraphs 1038 (7)(b) and (c) and s. 893.0551. 1039 (b) The department, when the direct support organization 1040 receives at least $20,000 in nonstate moneys or the state 1041 receives at least $20,000 in federal grants for the prescription 1042 drug monitoring program, and in consultation with the Office of 1043 Drug Control, shall adopt rules as necessary concerning the 1044 reporting, accessing the database, evaluation, management, 1045 development, implementation, operation, security, and storage of 1046 information within the system, including rules for when patient 1047 advisory reports are provided to pharmacies and prescribers. The 1048 patient advisory report shall be provided in accordance with s. 1049 893.13(7)(a)8. The department shall work with the professional 1050 health care licensure boards, such as the Board of Medicine, the 1051 Board of Osteopathic Medicine, and the Board of Pharmacy; other 1052 appropriate organizations, such as the Florida Pharmacy 1053 Association, the Office of Drug Control, the Florida Medical 1054 Association, the Florida Retail Federation, and the Florida 1055 Osteopathic Medical Association, including those relating to 1056 pain management; and the Attorney General, the Department of Law 1057 Enforcement, and the Agency for Health Care Administration to 1058 develop rules appropriate for the prescription drug monitoring 1059 program. 1060 (c) All dispensers and prescribers subject to these 1061 reporting requirements shall be notified by the department of 1062 the implementation date for such reporting requirements. 1063 (d) The program manager shall work with professional health 1064 care licensure boards and the stakeholders listed in paragraph 1065 (b) to develop rules appropriate for identifying indicators of 1066 controlled substance abuse. 1067 (e) The department shall establish a method to allow 1068 corrections to the database when notified by a health care 1069 practitioner or pharmacist. 1070 (3) The pharmacy dispensing the controlled substance and 1071 each prescriber who directly dispenses a controlled substance 1072 shall submit to the electronic system, by a procedure and in a 1073 format established by the department and consistent with an 1074 ASAP-approved format, the following information for inclusion in 1075 the database: 1076 (a) The name of the prescribing practitioner, the 1077 practitioner’s federal Drug Enforcement Administration 1078 registration number, the practitioner’s National Provider 1079 Identification (NPI) or other appropriate identifier, and the 1080 date of the prescription. 1081 (b) The date the prescription was filled and the method of 1082 payment, such as cash by an individual, insurance coverage 1083 through a third party, or Medicaid payment. This paragraph does 1084 not authorize the department to include individual credit card 1085 numbers or other account numbers in the database. 1086 (c) The full name, address, and date of birth of the person 1087 for whom the prescription was written. 1088 (d) The name, national drug code, quantity, and strength of 1089 the controlled substance dispensed. 1090 (e) The full name, federal Drug Enforcement Administration 1091 registration number, and address of the pharmacy or other 1092 location from which the controlled substance was dispensed. If 1093 the controlled substance was dispensed by a practitioner other 1094 than a pharmacist, the practitioner’s full name, federal Drug 1095 Enforcement Administration registration number, and address. 1096 (f) The name of the pharmacy or practitioner, other than a 1097 pharmacist, dispensing the controlled substance and the 1098 practitioner’s National Provider Identification (NPI). 1099 (g) Other appropriate identifying information as determined 1100 by department rule. 1101 (h) The number of refills ordered and whether the drug was 1102 dispensed as a refill of a prescription or was a first-time 1103 request. 1104 (4) Each time a controlled substance is dispensed to an 1105 individual, the controlled substance shall be reported to the 1106 department through the system as soon thereafter as possible, 1107 but not more than 715days after the date the controlled 1108 substance is dispensed unless an extension is approved by the 1109 department for cause as determined by rule. A dispenser must 1110 meet the reporting requirements of this section by providing the 1111 required information concerning each controlled substance that 1112 it dispensed in a department-approved, secure methodology and 1113 format. Such approved formats may include, but are not limited 1114 to, submission via the Internet, on a disc, or by use of regular 1115 mail. 1116 (5) When the following acts of dispensing or administering 1117 occur, the following are exempt from reporting under this 1118 section for that specific act of dispensing or administration: 1119 (a) A health care practitioner when administering a 1120 controlled substance directly to a patient if the amount of the 1121 controlled substance is adequate to treat the patient during 1122 that particular treatment session. 1123 (b) A pharmacist or health care practitioner when 1124 administering a controlled substance to a patient or resident 1125 receiving care as a patient at a hospital, nursing home, 1126 ambulatory surgical center, hospice, or intermediate care 1127 facility for the developmentally disabled which is licensed in 1128 this state. 1129(c) A practitioner when administering or dispensing a1130controlled substance in the health care system of the Department1131of Corrections.1132 (c)(d)A practitioner when administering a controlled 1133 substance in the emergency room of a licensed hospital. 1134 (d)(e)A health care practitioner when administering or 1135 dispensing a controlled substance to a person under the age of 1136 16 if the amount of the controlled substance is adequate to 1137 treat the patient during that particular treatment session. 1138 (e)(f)A pharmacist or a dispensing practitioner when 1139 dispensing a one-time, 48-hour72-houremergency resupply of a 1140 controlled substance to a patient. 1141 (6) The department may establish when to suspend and when 1142 to resume reporting information during a state-declared or 1143 nationally declared disaster. 1144 (7)(a) A practitioner or pharmacist who dispenses a 1145 controlled substance must submit the information required by 1146 this section in an electronic or other method in an ASAP format 1147 approved by rule of the department unless otherwise provided in 1148 this section. The cost to the dispenser in submitting the 1149 information required by this section may not be material or 1150 extraordinary. Costs not considered to be material or 1151 extraordinary include, but are not limited to, regular postage, 1152 electronic media, regular electronic mail, and facsimile 1153 charges. 1154 (b)1. In order for a pharmacy, prescriber, practitioner, or 1155 dispenser toshallhave access to information in the 1156 prescription drug monitoring program’s database which relates to 1157 a patient of that pharmacy, prescriber, practitioner, or 1158 dispenser, the pharmacy, prescriber, practitioner, or dispenser 1159 shall register with the department by submitting a registering 1160 document provided by the department. The document and validation 1161 of that document shall be determined by the department. Before a 1162 pharmacy, prescriber, practitioner, or dispenser is granted 1163 access to information in the database from the prescription drug 1164 monitoring program, the department shall approve the submitted 1165 document. Upon approval, the department shall grant the 1166 registrant access to the appropriate information in the 1167 prescription drug monitoring program’s databasein a manner1168established by the department as needed for the purpose of1169reviewing the patient’s controlled substance prescription1170history. 1171 2. Other access to the program’s database shall be limited 1172 to the program’s manager and to the designated program and 1173 support staff, who may act only at the direction of the program 1174 manager or, in the absence of the program manager, as 1175 authorized. Access by the program manager or such designated 1176 staff is for prescription drug program management only or for 1177 management of the program’s database and its system in support 1178 of the requirements of this section and in furtherance of the 1179 prescription drug monitoring program. Confidential and exempt 1180 information in the database shall be released only as provided 1181 in paragraph (c) and s. 893.0551. The program manager, 1182 designated program and support staff who act at the direction of 1183 or in the absence of the program manager, and any individual who 1184 has similar access regarding the management of the database from 1185 the prescription drug monitoring program shall submit 1186 fingerprints to the department for background screening. The 1187 department shall follow the procedure established by the 1188 Department of Law Enforcement to request a statewide criminal 1189 history record check and to request that the Department of Law 1190 Enforcement forward the fingerprints to the Federal Bureau of 1191 Investigation for a national criminal history record check. 1192 (c) The following entities mayshallnot havebe allowed1193 direct access to information in the prescription drug monitoring 1194 program database but may request from the program manager and, 1195 when authorized by the program manager, the program manager’s 1196 program and support staff, information that is confidential and 1197 exempt under s. 893.0551. Prior to release, the request shall be 1198 verified as authentic and authorized with the requesting 1199 organization by the program manager, the program manager’s 1200 program and support staff, or as determined in rules by the 1201 department as being authentic and as having been authorized by 1202 the requesting entity: 1203 1. The department or its relevant health care regulatory 1204 boards responsible for the licensure, regulation, or discipline 1205 of practitioners, pharmacists, or other persons who are 1206 authorized to prescribe, administer, or dispense controlled 1207 substances and who are involved in a specific controlled 1208 substance investigation involving a designated person for one or 1209 more prescribed controlled substances. 1210 2. The Attorney General for Medicaid fraud cases or 1211 Medicaid investigations involving prescribed controlled 1212 substances. 1213 3. A law enforcement agency during active investigations 1214 regarding potential criminal activity, fraud, or theft regarding 1215 prescribed controlled substances. 1216 4. A patient or the legal guardian or designated health 1217 care surrogate of an incapacitated patient as described in s. 1218 893.0551 who, for the purpose of verifying the accuracy of the 1219 database information, submits a written and notarized request 1220 that includes the patient’s full name, address, and date of 1221 birth, and includes the same information if the legal guardian 1222 or health care surrogate submits the request. The patient’s 1223 phone number and a copy of a government-issued photo 1224 identification must be provided in person to the program manager 1225 along with the notarized request. The request shall be validated 1226 by the department to verify the identity of the patient and the 1227 legal guardian or health care surrogate, if the patient’s legal 1228 guardian or health care surrogate is the requestor. Such 1229 verification is also required for any request to change a 1230 patient’s prescription history or other information related to 1231 his or her information in the electronic database. 1232 5. The Agency for Health Care Administration for Medicaid 1233 fraud cases or Medicaid investigations involving prescribed 1234 controlled substances. 1235 1236 Information in the database for the electronic prescription drug 1237 monitoring system is not discoverable or admissible in any civil 1238 or administrative action, except in an investigation and 1239 disciplinary proceeding by the department or the appropriate 1240 regulatory board. 1241 (d) The following entities mayshallnot havebe allowed1242 direct access to information in the prescription drug monitoring 1243 program database but may request from the program manager and, 1244 when authorized by the program manager, the program manager’s 1245 program and support staff, information that contains no 1246 identifying information of any patient, physician, health care 1247 practitioner, prescriber, or dispenser and that is not 1248 confidential and exempt: 1249 1. Department staff for the purpose of calculating 1250 performance measures pursuant to subsection (8). 1251 2. The Program Implementation and Oversight Task Force for 1252 its reporting to the Governor, the President of the Senate, and 1253 the Speaker of the House of Representatives regarding the 1254 prescription drug monitoring program. This subparagraph expires 1255 July 1, 2012. 1256 (e) All transmissions of data required by this section must 1257 comply with relevant state and federal privacy and security laws 1258 and regulations. However, any authorized agency or person under 1259 s. 893.0551 receiving such information as allowed by s. 893.0551 1260 may maintain the information received for up to 24 months before 1261 purging it from his or her records or maintain it for longer 1262 than 24 months if the information is pertinent to ongoing health 1263 care or an active law enforcement investigation or prosecution. 1264 (f) The program manager, upon determining a pattern 1265 consistent with the rules established under paragraph (2)(d) and 1266 having cause to believe a violation of s. 893.13(7)(a)8., 1267 (8)(a), or (8)(b) has occurred, may provide relevant information 1268 to the applicable law enforcement agency. 1269 (8) To assist in fulfilling program responsibilities, 1270 performance measures shall be reported annually to the Governor, 1271 the President of the Senate, and the Speaker of the House of 1272 Representatives by the department each December 1, beginning in 1273 2011. Data that does not contain patient, physician, health care 1274 practitioner, prescriber, or dispenser identifying information 1275 may be requested during the year by department employees so that 1276 the department may undertake public health care and safety 1277 initiatives that take advantage of observed trends. Performance 1278 measures may include, but are not limited to, efforts to achieve 1279 the following outcomes: 1280 (a) Reduction of the rate of inappropriate use of 1281 prescription drugs through department education and safety 1282 efforts. 1283 (b) Reduction of the quantity of pharmaceutical controlled 1284 substances obtained by individuals attempting to engage in fraud 1285 and deceit. 1286 (c) Increased coordination among partners participating in 1287 the prescription drug monitoring program. 1288 (d) Involvement of stakeholders in achieving improved 1289 patient health care and safety and reduction of prescription 1290 drug abuse and prescription drug diversion. 1291 (9) Any person who willfully and knowingly fails to report 1292 the dispensing of a controlled substance as required by this 1293 section commits a misdemeanor of the first degree, punishable as 1294 provided in s. 775.082 or s. 775.083. 1295 (10)All costs incurred by the department in administering1296the prescription drug monitoring program shall be funded through1297federal grants or private funding applied for or received by the1298state. The department may not commit funds for the monitoring1299program without ensuring funding is available. The prescription1300drug monitoring program and the implementation thereof are1301contingent upon receipt of the nonstate funding.The department 1302 and state government shall cooperate with the direct-support 1303 organization established pursuant to subsection (11) in seeking 1304 federal grant funds, other nonstate grant funds, gifts, 1305 donations, or other private moneys for the department so long as 1306 the costs of doing so are not considered material. Nonmaterial 1307 costs for this purpose include, but are not limited to, the 1308 costs of mailing and personnel assigned to research or apply for 1309 a grant. Notwithstanding the exemptions to competitive 1310 solicitation requirements under s. 287.057(3)(f), the department 1311 shall comply with the competitive-solicitation requirements 1312 under s. 287.057 for the procurement of any goods or services 1313 required by this section. 1314 (11) The Office of Drug Control, in coordination with the 1315 department, may establish a direct-support organization that has 1316 a board consisting of at least five members to provide 1317 assistance, funding, and promotional support for the activities 1318 authorized for the prescription drug monitoring program. 1319 (a) As used in this subsection, the term “direct-support 1320 organization” means an organization that is: 1321 1. A Florida corporation not for profit incorporated under 1322 chapter 617, exempted from filing fees, and approved by the 1323 Department of State. 1324 2. Organized and operated to conduct programs and 1325 activities; raise funds; request and receive grants, gifts, and 1326 bequests of money; acquire, receive, hold, and invest, in its 1327 own name, securities, funds, objects of value, or other 1328 property, either real or personal; and make expenditures or 1329 provide funding to or for the direct or indirect benefit of the 1330 department in the furtherance of the prescription drug 1331 monitoring program. 1332 (b) The direct-support organization is not considered a 1333 lobbying firm within the meaning of s. 11.045. 1334 (c) The director of the Office of Drug Control shall 1335 appoint a board of directors for the direct-support 1336 organization. The director may designate employees of the Office 1337 of Drug Control, state employees other than state employees from 1338 the department, and any other nonstate employees as appropriate, 1339 to serve on the board. Members of the board shall serve at the 1340 pleasure of the director of the Office of Drug Control. The 1341 director shall provide guidance to members of the board to 1342 ensure that moneys received by the direct-support organization 1343 are not received from inappropriate sources. Inappropriate 1344 sources include, but are not limited to, donors, grantors, 1345 persons, or organizations that may monetarily or substantively 1346 benefit from the purchase of goods or services by the department 1347 in furtherance of the prescription drug monitoring program. 1348 (d) The direct-support organization shall operate under 1349 written contract with the Office of Drug Control. The contract 1350 must, at a minimum, provide for: 1351 1. Approval of the articles of incorporation and bylaws of 1352 the direct-support organization by the Office of Drug Control. 1353 2. Submission of an annual budget for the approval of the 1354 Office of Drug Control. 1355 3. Certification by the Office of Drug Control in 1356 consultation with the department that the direct-support 1357 organization is complying with the terms of the contract in a 1358 manner consistent with and in furtherance of the goals and 1359 purposes of the prescription drug monitoring program and in the 1360 best interests of the state. Such certification must be made 1361 annually and reported in the official minutes of a meeting of 1362 the direct-support organization. 1363 4. The reversion, without penalty, to the Office of Drug 1364 Control, or to the state if the Office of Drug Control ceases to 1365 exist, of all moneys and property held in trust by the direct 1366 support organization for the benefit of the prescription drug 1367 monitoring program if the direct-support organization ceases to 1368 exist or if the contract is terminated. 1369 5. The fiscal year of the direct-support organization, 1370 which must begin July 1 of each year and end June 30 of the 1371 following year. 1372 6. The disclosure of the material provisions of the 1373 contract to donors of gifts, contributions, or bequests, 1374 including such disclosure on all promotional and fundraising 1375 publications, and an explanation to such donors of the 1376 distinction between the Office of Drug Control and the direct 1377 support organization. 1378 7. The direct-support organization’s collecting, expending, 1379 and providing of funds to the department for the development, 1380 implementation, and operation of the prescription drug 1381 monitoring program as described in this section and s. 2, 1382 chapter 2009-198, Laws of Florida, as long as the task force is 1383 authorized. The direct-support organization may collect and 1384 expend funds to be used for the functions of the direct-support 1385 organization’s board of directors, as necessary and approved by 1386 the director of the Office of Drug Control. In addition, the 1387 direct-support organization may collect and provide funding to 1388 the department in furtherance of the prescription drug 1389 monitoring program by: 1390 a. Establishing and administering the prescription drug 1391 monitoring program’s electronic database, including hardware and 1392 software. 1393 b. Conducting studies on the efficiency and effectiveness 1394 of the program to include feasibility studies as described in 1395 subsection (13). 1396 c. Providing funds for future enhancements of the program 1397 within the intent of this section. 1398 d. Providing user training of the prescription drug 1399 monitoring program, including distribution of materials to 1400 promote public awareness and education and conducting workshops 1401 or other meetings, for health care practitioners, pharmacists, 1402 and others as appropriate. 1403 e. Providing funds for travel expenses. 1404 f. Providing funds for administrative costs, including 1405 personnel, audits, facilities, and equipment. 1406 g. Fulfilling all other requirements necessary to implement 1407 and operate the program as outlined in this section. 1408 (e) The activities of the direct-support organization must 1409 be consistent with the goals and mission of the Office of Drug 1410 Control, as determined by the office in consultation with the 1411 department, and in the best interests of the state. The direct 1412 support organization must obtain a written approval from the 1413 director of the Office of Drug Control for any activities in 1414 support of the prescription drug monitoring program before 1415 undertaking those activities. 1416 (f) The Office of Drug Control, in consultation with the 1417 department, may permit, without charge, appropriate use of 1418 administrative services, property, and facilities of the Office 1419 of Drug Control and the department by the direct-support 1420 organization, subject to this section. The use must be directly 1421 in keeping with the approved purposes of the direct-support 1422 organization and may not be made at times or places that would 1423 unreasonably interfere with opportunities for the public to use 1424 such facilities for established purposes. Any moneys received 1425 from rentals of facilities and properties managed by the Office 1426 of Drug Control and the department may be held by the Office of 1427 Drug Control or in a separate depository account in the name of 1428 the direct-support organization and subject to the provisions of 1429 the letter of agreement with the Office of Drug Control. The 1430 letter of agreement must provide that any funds held in the 1431 separate depository account in the name of the direct-support 1432 organization must revert to the Office of Drug Control if the 1433 direct-support organization is no longer approved by the Office 1434 of Drug Control to operate in the best interests of the state. 1435 (g) The Office of Drug Control, in consultation with the 1436 department, may adopt rules under s. 120.54 to govern the use of 1437 administrative services, property, or facilities of the 1438 department or office by the direct-support organization. 1439 (h) The Office of Drug Control may not permit the use of 1440 any administrative services, property, or facilities of the 1441 state by a direct-support organization if that organization does 1442 not provide equal membership and employment opportunities to all 1443 persons regardless of race, color, religion, gender, age, or 1444 national origin. 1445 (i) The direct-support organization shall provide for an 1446 independent annual financial audit in accordance with s. 1447 215.981. Copies of the audit shall be provided to the Office of 1448 Drug Control and the Office of Policy and Budget in the 1449 Executive Office of the Governor. 1450 (j) The direct-support organization may not exercise any 1451 power under s. 617.0302(12) or (16). 1452 (12) A prescriber or dispenser may have access to the 1453 information under this section which relates to a patient of 1454 that prescriber or dispenser as needed for the purpose of 1455 reviewing the patient’s controlled drug prescription history. A 1456 prescriber or dispenser acting in good faith is immune from any 1457 civil, criminal, or administrative liability that might 1458 otherwise be incurred or imposed for receiving or using 1459 information from the prescription drug monitoring program. This 1460 subsection does not create a private cause of action, and a 1461 person may not recover damages against a prescriber or dispenser 1462 authorized to access information under this subsection for 1463 accessing or failing to access such information. 1464 (13) To the extent that funding is provided for such 1465 purpose through federal or private grants or gifts and other 1466 types of available moneys, the department, in collaboration with 1467 the Office of Drug Control, shall study the feasibility of 1468 enhancing the prescription drug monitoring program for the 1469 purposes of public health initiatives and statistical reporting 1470 that respects the privacy of the patient, the prescriber, and 1471 the dispenser. Such a study shall be conducted in order to 1472 further improve the quality of health care services and safety 1473 by improving the prescribing and dispensing practices for 1474 prescription drugs, taking advantage of advances in technology, 1475 reducing duplicative prescriptions and the overprescribing of 1476 prescription drugs, and reducing drug abuse. The requirements of 1477 the National All Schedules Prescription Electronic Reporting 1478 (NASPER) Act are authorized in order to apply for federal NASPER 1479 funding. In addition, the direct-support organization shall 1480 provide funding for the department, in collaboration with the 1481 Office of Drug Control, to conduct training for health care 1482 practitioners and other appropriate persons in using the 1483 monitoring program to support the program enhancements. 1484 (14) A pharmacist, pharmacy, or dispensing health care 1485 practitioner or his or her agent, before releasing a controlled 1486 substance to any person not known to such dispenser, shall 1487 require the person purchasing, receiving, or otherwise acquiring 1488 the controlled substance to present valid photographic 1489 identification or other verification of his or her identity to 1490 the dispenser. If the person does not have proper 1491 identification, the dispenser may verify the validity of the 1492 prescription and the identity of the patient with the prescriber 1493 or his or her authorized agent. Verification of health plan 1494 eligibility through a real-time inquiry or adjudication system 1495 will be considered to be proper identification. This subsection 1496 does not apply in an institutional setting or to a long-term 1497 care facility, including, but not limited to, an assisted living 1498 facility or a hospital to which patients are admitted. As used 1499 in this subsection, the term “proper identification” means an 1500 identification that is issued by a state or the Federal 1501 Government containing the person’s photograph, printed name, and 1502 signature or a document considered acceptable under 8 C.F.R. s. 1503 274a.2(b)(1)(v)(A) and (B). 1504 (15) The Agency for Health Care Administration shall 1505 continue the promotion of electronic prescribing by health care 1506 practitioners, health care facilities, and pharmacies under s. 1507 408.0611. 1508 (16) By October 1, 2010, the department shall adopt rules 1509 pursuant to ss. 120.536(1) and 120.54 to administer the 1510 provisions of this section, which shall include as necessary the 1511 reporting, accessing, evaluation, management, development, 1512 implementation, operation, and storage of information within the 1513 monitoring program’s system. 1514 (17) After the prescription drug monitoring program has 1515 been operational for 12 months, the State Surgeon General shall 1516 enter into reciprocal agreements for the sharing of prescription 1517 drug monitoring information with any other state that has a 1518 compatible prescription drug monitoring program. If the State 1519 Surgeon General evaluates the prescription drug monitoring 1520 program of another state as authorized in this subsection, 1521 priority shall be given to a state that is contiguous with the 1522 borders of this state. 1523 (a) In determining compatibility, the State Surgeon General 1524 shall consider: 1525 1. The essential purposes of the program and the success of 1526 the program in fulfilling those purposes. 1527 2. The safeguards for privacy of patient records and the 1528 success of the program in protecting patient privacy. 1529 3. The persons authorized to view the data collected by the 1530 program. Comparable organizations and professions for 1531 practitioners in other states, law enforcement agencies, the 1532 Attorney General’s Medicaid Fraud Unit, medical regulatory 1533 boards, and, as needed, management staff who have similar duties 1534 as management staff who work with the prescription drug 1535 monitoring program as authorized in s. 893.0551 are authorized 1536 access upon approval by the State Surgeon General. 1537 4. The schedules of the controlled substances that are 1538 monitored. 1539 5. The data required to be submitted for each prescription. 1540 6. Any implementing criteria deemed essential for a 1541 thorough comparison. 1542 (b) The State Surgeon General shall annually review any 1543 agreement to determine its continued compatibility with the 1544 prescription drug monitoring program in this state. 1545 (c) Any agreement between the State Surgeon General and 1546 another state shall prohibit the sharing of information 1547 concerning a resident of this state or a practitioner, 1548 pharmacist, or other prescriber for any purpose that is not 1549 otherwise authorized by this section or s. 893.0551. 1550 Section 22. Present subsections (4), (5), (6), and (7) of 1551 section 893.0551, Florida Statutes, are redesignated as 1552 subsections (5), (6), (7), and (8), respectively, and a new 1553 subsection (4) is added to that section, to read: 1554 893.0551 Public records exemption for the prescription drug 1555 monitoring program.— 1556 (4) The department may disclose confidential and exempt 1557 information contained in records held by the department under s. 1558 893.055 if the State Surgeon General has entered into a 1559 reciprocal agreement for the sharing of prescription drug 1560 monitoring information with any other state that has a 1561 compatible prescription drug monitoring program. 1562 (a) The reciprocal agreement may allow the following 1563 persons from another state to receive information from the 1564 prescription drug monitoring program if approved by the State 1565 Surgeon General: 1566 1. A designated representative of a state professional 1567 licensing, certification, or regulatory agency charged with 1568 oversight of those persons authorized to prescribe or dispense 1569 controlled substances for the purpose of a bona fide, specific 1570 investigation of a prescription of a controlled substance which 1571 involves a designated person. As required in s. 893.055, this 1572 authorization does not preclude the requirement for the program 1573 manager to review the request for information and validate it. 1574 2. A health care practitioner or pharmacist licensed in the 1575 state from which the request originates. Such health care 1576 practitioner or pharmacist shall certify that the requested 1577 information is for the purpose of providing medical or 1578 pharmaceutical treatment to a bona fide, current patient. The 1579 health care practitioner or pharmacist shall follow all the 1580 procedures required in s. 893.055 and rules established by the 1581 department for a health care practitioner or pharmacist to 1582 request information from the database. 1583 3. A law enforcement officer from another state: 1584 a. Who is a member of a sheriff’s department or a police 1585 department; 1586 b. Who is authorized by law to conduct criminal 1587 investigations and make arrests; 1588 c. Whose duty it is to enforce the laws of his or her state 1589 relating to controlled substances; and 1590 d. Who is engaged in a bona fide specific, active 1591 investigation involving a designated person regarding 1592 prescriptions for controlled substances. 1593 1594 As required in s. 893.055, this authorization does not preclude 1595 the requirement for the program manager to review the request 1596 for information and validate it. This authorization also does 1597 not preclude the ability to provide a report to a law 1598 enforcement agency in another state under s. 893.055(7) or this 1599 subsection. 1600 (b) Any agreement between the State Surgeon General and 1601 another state shall prohibit the sharing of information 1602 concerning a resident of this state, a patient whose information 1603 is in the program’s database, or a practitioner, pharmacy, 1604 pharmacist, health care practitioner, or other prescriber for 1605 any purpose that is not otherwise authorized by this section or 1606 s. 893.055, and the information must be provided according to 1607 the State Surgeon General’s determination of compatibility as 1608 described in s. 893.055(17). 1609 Section 23. Subsections (1), (4), and (5) of section 1610 893.07, Florida Statutes, are amended, and a new subsection (6) 1611 is added to that section to read: 1612 893.07 Records.— 1613 (1) Notwithstanding any other provision of law and in 1614 consonance with the authority of State v. Carter, 23 So. 3d 798 1615 (Fla. 1st DCA 2009) and State v. Tamulonis, 39 So. 3d 524 (Fla. 1616 2nd DCA 2010), every person who engages in the manufacture, 1617 compounding, mixing, cultivating, growing, or by any other 1618 process producing or preparing, or in the dispensing, 1619 importation, or, as a wholesaler, distribution, of controlled 1620 substances shall: 1621 (a) On January 1, 1974, or as soon thereafter as any person 1622 first engages in such activity, and every second year 1623 thereafter, make a complete and accurate record of all stocks of 1624 controlled substances on hand. The inventory may be prepared on 1625 the regular physical inventory date which is nearest to, and 1626 does not vary by more than 6 months from, the biennial date that 1627 would otherwise apply. As additional substances are designated 1628 for control under this chapter, they shall be inventoried as 1629 provided for in this subsection. 1630 (b) On and after January 1, 1974, maintain, on a current 1631 basis, a complete and accurate record of each substance 1632 manufactured, received, sold, delivered, or otherwise disposed 1633 of by him or her, except that this subsection shall not require 1634 the maintenance of a perpetual inventory. 1635 1636 Compliance with the provisions of federal law pertaining to the 1637 keeping of records of controlled substances shall be deemed a 1638 compliance with the requirements of this subsection. 1639 (4) Every inventory or record required by this chapter, 1640 including prescription records, shall be maintained: 1641 (a) Separately from all other records of the registrant, or 1642 (b) Alternatively, in the case of Schedule III, IV, or V 1643 controlled substances, in such form that information required by 1644 this chapter is readily retrievable from the ordinary business 1645 records of the registrant. 1646 1647 In either case, such records described in this subsection shall 1648 be kept and made available for a period of at least 2 years for 1649 inspection and copying by law enforcement officers whose duty it 1650 is to enforce the laws of this state relating to controlled 1651 substances. 1652 (5) Each person shall maintain a record that containswhich1653shallcontaina detailed list of controlled substances lost, 1654 destroyed, or stolen, if any; the kind and quantity of such 1655 controlled substances; and the date of the discovering of such 1656 loss, destruction, or theft. If a person discovers the theft or 1657 loss of a controlled substance, such person shall report the 1658 theft or loss to a local county sheriff’s office and the 1659 Department of Law Enforcement within 48 hours after the 1660 discovery of such theft or loss. A person who fails to report 1661 the theft or loss of a controlled substance under this 1662 subsection is subject to an administrative fine: 1663 (a) Not to exceed $100 per incident; or 1664 (b) Not to exceed $500 per incident if it is a theft or 1665 loss of a controlled substance listed under Schedule II. 1666 (6) The Legislature finds that the opinions rendered in 1667 State v. Carter, 23 So. 3d 798 (Fla. 1st DCA 2009), and State v. 1668 Tamulonis, 39 So. 3d 524 (Fla. 2nd DCA 2010), correctly construe 1669 this Legislature’s intent that the inspection powers previously 1670 conferred upon law enforcement officers which allow such 1671 officers to access and review pharmacy records concerning 1672 controlled substances are to be exercised properly by such law 1673 enforcement officers without the requirement of a subpoena or 1674 search warrant being sought or issued to examine and copy such 1675 records, and without the requirement that those persons to whom 1676 particular pharmacy records refer be given notice of the 1677 records’ examination and copying under this section. 1678 Section 24. Subsections (7) and (8) of section 893.13, 1679 Florida Statutes, are amended to read: 1680 893.13 Prohibited acts; penalties.— 1681 (7)(a) AIt is unlawful for anyperson may not: 1682 1.ToDistribute or dispense a controlled substance in 1683 violation of this chapter. 1684 2.ToRefuse or fail to make, keep, or furnish any record, 1685 notification, order form, statement, invoice, or information 1686 required under this chapter. 1687 3.ToRefuseanentry into any premises for any inspection 1688 ortorefuse to allow any inspection authorized by this chapter. 1689 4.ToDistribute a controlled substance named or described 1690 in s. 893.03(1) or (2) except pursuant to an order form as 1691 required by s. 893.06. 1692 5.ToKeep or maintain any store, shop, warehouse, 1693 dwelling, building, vehicle, boat, aircraft, or other structure 1694 or place which is resorted to by persons using controlled 1695 substances in violation of this chapter for the purpose of using 1696 these substances, or which is used for keeping or selling them 1697 in violation of this chapter. 1698 6.ToUse to his or her own personal advantage, orto1699 reveal, any information obtained in enforcement of this chapter 1700 except in a prosecution or administrative hearing for a 1701 violation of this chapter. 1702 7.ToPossess a prescription form which has not been 1703 completed and signed by the practitioner whose name appears 1704 printed thereon, unless the person is that practitioner, is an 1705 agent or employee of that practitioner, is a pharmacist, or is a 1706 supplier of prescription forms who is authorized by that 1707 practitioner to possess those forms. 1708 8.ToWithhold information from a practitioner from whom 1709 the person seeks to obtain a controlled substance or a 1710 prescription for a controlled substance that the person making 1711 the request has received a controlled substance or a 1712 prescription for a controlled substance of like therapeutic use 1713 from another practitioner within the previous 30 days. 1714 9.ToAcquire or obtain, or attempt to acquire or obtain, 1715 possession of a controlled substance by misrepresentation, 1716 fraud, forgery, deception, or subterfuge. 1717 10.ToAffix any false or forged label to a package or 1718 receptacle containing a controlled substance. 1719 11.ToFurnish false or fraudulent material information in, 1720 or omit any material information from, any report or other 1721 document required to be kept or filed under this chapter or any 1722 record required to be kept by this chapter. 1723 12.ToStore anhydrous ammonia in a container that is not 1724 approved by the United States Department of Transportation to 1725 hold anhydrous ammonia or is not constructed in accordance with 1726 sound engineering, agricultural, or commercial practices. 1727 13. With the intent to obtain a controlled substance or 1728 combination of controlled substances that are not medically 1729 necessary for the person or an amount of a controlled substance 1730 or substances that are not medically necessary for the person, 1731 obtain or attempt to obtain from a practitioner a controlled 1732 substance or a prescription for a controlled substance by 1733 misrepresentation, fraud, forgery, deception, subterfuge, or 1734 concealment of a material fact. For purposes of this 1735 subparagraph, a material fact includes whether the person has an 1736 existing prescription for a controlled substance issued for the 1737 same period of time by another practitioner or as described in 1738 subparagraph 8. 1739 (b) A health care practitioner, with the intent to provide 1740 a controlled substance or combination of controlled substances 1741 that are not medically necessary to his or her patient or an 1742 amount of controlled substances that are not medically necessary 1743 for his or her patient, may not provide a controlled substance 1744 or a prescription for a controlled substance by 1745 misrepresentation, fraud, forgery, deception, subterfuge, or 1746 concealment of a material fact. For purposes of this paragraph, 1747 a material fact includes whether the patient has an existing 1748 prescription for a controlled substance issued for the same 1749 period of time by another practitioner or as described in 1750 subparagraph (a)8. 1751 (c) Any person who adulterates a controlled substance for 1752 directed off-label use without authorization by a prescribing 1753 physician violates the provisions of subparagraph (a)1. and 1754 causes the issuance of the entire prescription for the 1755 controlled substance to become invalid. A law enforcement 1756 officer in the performance of his or her official duties may 1757 seize the adulterated or off-label prescribed controlled 1758 substance as evidence. The controlled substance may be returned 1759 to the owner only with a notarized affidavit from the original 1760 prescribing practitioner who has knowledge and gave 1761 authorization and explicit directions for the adulteration or 1762 off-label use of the controlled substance. 1763 (d)(b)Any person who violates the provisions of 1764 subparagraphs (a)1.-7. commits a misdemeanor of the first 1765 degree, punishable as provided in s. 775.082 or s. 775.083; 1766 except that, upon a second or subsequent violation, the person 1767 commits a felony of the third degree, punishable as provided in 1768 s. 775.082, s. 775.083, or s. 775.084. 1769 (e)(c)Any person who violates the provisions of 1770 subparagraphs (a)8.-12. commits a felony of the third degree, 1771 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 1772 (f) A person or health care practitioner who violates the 1773 provisions of paragraph (b) or subparagraph (a)13. commits: 1774 1. A felony of the third degree, punishable as provided in 1775 s. 775.082, s. 775.083, or s. 775.084, if any controlled 1776 substance that is the subject of the offense is listed in 1777 Schedule II, Schedule III, or Schedule IV. 1778 2. A misdemeanor of the first degree, punishable as 1779 provided in s. 775.082 or s. 775.083, if any controlled 1780 substance that is the subject of the offense is listed in 1781 Schedule V. 1782 (8)(a) Notwithstanding subsection (9), a prescribing 1783 practitioner may not: 1784 1. Knowingly assist a patient, other person, or the owner 1785 of an animal in obtaining a controlled substance through 1786 deceptive, untrue, or fraudulent representations in or related 1787 to the practice of the prescribing practitioner’s professional 1788 practice; 1789 2. Employ a trick or scheme in the practice of the 1790 prescribing practitioner’s professional practice to assist a 1791 patient, other person, or the owner of an animal in obtaining a 1792 controlled substance; 1793 3. Knowingly write a prescription for a controlled 1794 substance for a fictitious person;or1795 4. Write a prescription for a controlled substance for a 1796 patient, other person, or an animal if the sole purpose of 1797 writing such prescription is to provide a monetary benefit to, 1798 or obtain a monetary benefit for, the prescribing practitioner; 1799 or.1800 5. Write a prescription for a controlled substance for a 1801 patient, other person, or an animal and authorize or direct the 1802 adulteration of the dispensed form of the controlled substance 1803 for the purpose of ingestion by means of inhalation, injection, 1804 or any other means that is not medically necessary for the 1805 treatment of the patient. 1806 (b) If the prescribing practitioner wrote a prescription or 1807 multiple prescriptions for a controlled substance for the 1808 patient, other person, or animal for which there was no medical 1809 necessity, or which was in excess of what was medically 1810 necessary to treat the patient, other person, or animal, that 1811 fact does not give rise to any presumption that the prescribing 1812 practitioner violated subparagraph (a)1., but may be considered 1813 with other competent evidence in determining whether the 1814 prescribing practitioner knowingly assisted a patient, other 1815 person, or the owner of an animal to obtain a controlled 1816 substance in violation of subparagraph (a)1. 1817 (c) A person who violates paragraph (a) commits a felony of 1818 the third degree, punishable as provided in s. 775.082, s. 1819 775.083, or s. 775.084. 1820 (d) Notwithstanding paragraph (c), if a prescribing 1821 practitioner has violated paragraph (a) and received $1,000 or 1822 more in payment for writing one or more prescriptions or, in the 1823 case of a prescription written for a controlled substance 1824 described in s. 893.135, has written one or more prescriptions 1825 for a quantity of a controlled substance which, individually or 1826 in the aggregate, meets the threshold for the offense of 1827 trafficking in a controlled substance under s. 893.15, the 1828 violation is reclassified as a felony of the second degree and 1829 ranked in level 4 of the Criminal Punishment Code. 1830 Section 25. Present subsections (3) through (10) of section 1831 893.138, Florida Statutes, are redesignated as subsections (4) 1832 through (11), respectively, and a new subsection (3) is added to 1833 that section, to read: 1834 893.138 Local administrative action to abate drug-related, 1835 prostitution-related, or stolen-property-related public 1836 nuisances and criminal gang activity.— 1837 (3) Any pain-management clinic, as described in s. 458.3265 1838 or s. 459.0137, which has been used on more than two occasions 1839 within a 6-month period as the site of a violation of: 1840 (a) Section 784.011, s. 784.021, s. 784.03, or s. 784.045, 1841 relating to assault and battery; 1842 (b) Section 810.02, relating to burglary; 1843 (c) Section 812.014, relating to dealing in theft; 1844 (d) Section 812.131, relating to robbery by sudden 1845 snatching; or 1846 (e) Section 893.13, relating to the unlawful distribution 1847 of controlled substances, 1848 1849 may be declared to be a public nuisance, and such nuisance may 1850 be abated pursuant to the procedures provided in this section. 1851 Section 26. This act shall take effect October 1, 2011.