Bill Text: FL S0818 | 2011 | Regular Session | Comm Sub
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-Comm_Sub.html
Bill Title: Controlled Substances
Spectrum:
Status: (Introduced - Dead) 2011-05-06 - Read 3rd time -SJ 1092 [S0818 Detail]
Download: Florida-2011-S0818-Comm_Sub.html
Florida Senate - 2011 CS for SB 818 By the Committee on Health Regulation; and Senator Fasano 588-02461B-11 2011818c1 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 for 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; providing penalties; amending 30 s. 458.3191, F.S.; revising the information in the 31 physician survey that is submitted by persons who 32 apply for licensure renewal as a physician under ch. 33 458 or ch. 459, F.S.; amending s. 458.3192, F.S.; 34 requiring the Department of Health to provide 35 nonidentifying information to the prescription drug 36 monitoring program’s Implementation and Oversight Task 37 Force regarding the number of physicians that are 38 registered with the prescription drug monitoring 39 program and that use the database from the program in 40 their practice; amending s. 458.3265, F.S.; revising 41 the list of entities that are not required to register 42 as a pain-management clinic; deleting certain 43 requirements for a physician to practice medicine in a 44 pain-management clinic; requiring a physician, an 45 advanced registered nurse practitioner, or a physician 46 assistant to perform an appropriate medical 47 examination of a patient on the same day that the 48 physician dispenses or prescribes a controlled 49 substance to the patient at a pain-management clinic; 50 requiring a physician who works in a pain-management 51 clinic to document the reason a prescription for a 52 certain dosage of a controlled substance is within the 53 proper standard of care; creating a felony of the 54 third degree for any person to register or attempt to 55 register a pain-management clinic through 56 misrepresentation or fraud; amending s. 458.327, F.S.; 57 providing additional penalties; amending s. 458.331, 58 F.S.; providing additional grounds for disciplinary 59 action by the Board of Medicine; amending s. 459.003, 60 F.S.; defining the term “dispensing physician” as it 61 relates to the practice of osteopathic medicine in 62 this state; amending s. 459.013, F.S.; providing 63 additional penalties; amending s. 459.0137, F.S.; 64 providing an exemption from the requirement that all 65 privately owned pain-management clinics, facilities, 66 or offices that advertise in any medium for any type 67 of pain-management services, or employ an osteopathic 68 physician who is primarily engaged in the treatment of 69 pain by prescribing or dispensing controlled substance 70 medications, must register with the Department of 71 Health; requiring a physician, an advanced registered 72 nurse practitioner, or a physician assistant to 73 perform an appropriate medical examination of a 74 patient on the same day that the physician dispenses 75 or prescribes a controlled substance to the patient at 76 a pain-management clinic; requiring an osteopathic 77 physician who works in a pain-management clinic to 78 document the reason a prescription for a certain 79 dosage of a controlled substance is within the proper 80 standard of care; creating a felony of the third 81 degree for a licensee or other person who serves as 82 the designated physician of a pain-management clinic 83 to register a pain-management clinic through 84 misrepresentation or fraud; amending s. 459.015, F.S.; 85 providing additional grounds for disciplinary action 86 by the Board of Osteopathic Medicine; amending s. 87 465.015, F.S.; prohibiting certain persons from 88 knowingly failing to report to the local county 89 sheriff’s office the commission of a felony involving 90 a person who acquires or obtains possession of a 91 controlled substance by misrepresentation, fraud, 92 forgery, deception, or subterfuge under certain 93 conditions; providing penalties; providing 94 requirements for reporting the commission of a felony 95 that involves a person who acquires or obtains 96 possession of a controlled substance by 97 misrepresentation, fraud, forgery, deception, or 98 subterfuge; providing that a pharmacist, pharmacy 99 intern, or other person employed by or at a pharmacy 100 is not subject to disciplinary action for reporting; 101 amending s. 465.0276, F.S.; requiring a practitioner 102 to register as a dispensing practitioner in order to 103 dispense controlled substances; amending s. 766.101, 104 F.S.; conforming a cross-reference; amending s. 105 810.02, F.S.; redefining the offense of burglary to 106 include the theft of a controlled substance within a 107 structure or conveyance; amending s. 812.014, F.S.; 108 redefining the offense of theft to include the theft 109 of a controlled substance; creating s. 893.021, F.S.; 110 providing conditions in which a drug is considered 111 adulterated; providing that a physician is not 112 prevented from directing or prescribing a change to 113 the recognized manufactured recommendations for use of 114 any controlled substance for a patient under certain 115 circumstances; requiring a prescribing physician to 116 indicate on the original prescription any deviation of 117 the recognized manufacturer’s recommended use of a 118 controlled substance; requiring a pharmacist or 119 physician to indicate such deviation on the label of 120 the prescription upon dispensing; amending s. 893.04, 121 F.S.; revising the required information that must 122 appear on the face of a prescription or written record 123 of a controlled substance before it is dispensed by a 124 pharmacist; amending s. 893.055, F.S.; requiring that 125 the prescription drug monitoring program comply with 126 the minimum requirements of the National All Schedules 127 Prescription Electronic Reporting Act; requiring the 128 Department of Health to establish a method to allow 129 corrections to the database of the prescription drug 130 monitoring program; requiring the number of refills 131 ordered and whether the drug was dispensed as a refill 132 or a first-time request to be included in the database 133 of the prescription drug monitoring program; revising 134 the number of days in which a dispensed controlled 135 substance must be reported to the department through 136 the prescription drug monitoring program; revising the 137 list of acts of dispensing or administering which are 138 exempt from reporting; requiring a pharmacy, 139 prescriber, practitioner, or dispenser to register 140 with the department by submitting a registering 141 document in order to have access to certain 142 information in the prescription drug monitoring 143 program’s database; requiring the department to 144 approve the registering document before granting 145 access to information in the prescription drug 146 monitoring program’s database; requiring criminal 147 background screening for those persons who have direct 148 access to the prescription drug monitoring program’s 149 database; authorizing the Attorney General to obtain 150 confidential and exempt information for Medicaid fraud 151 cases and Medicaid investigations; requiring certain 152 documentation to be provided to the program manager in 153 order to release confidential and exempt information 154 from the prescription drug monitoring program’s 155 database to a patient, legal guardian, or a designated 156 health care surrogate; authorizing the Agency for 157 Health Care Administration to obtain confidential and 158 exempt information from the prescription drug 159 monitoring program’s database for Medicaid fraud cases 160 and Medicaid investigations involving controlled 161 substances; deleting a provision requiring that 162 administrative costs of the prescription drug 163 monitoring program be funded through federal grants 164 and private sources; requiring the State Surgeon 165 General to enter into reciprocal agreements for the 166 sharing of information in the prescription drug 167 monitoring program with other states that have a 168 similar prescription drug monitoring program; 169 requiring the State Surgeon General to annually review 170 a reciprocal agreement to determine its compatibility; 171 providing requirements for compatibility; prohibiting 172 the sharing of certain information; amending s. 173 893.0551, F.S.; authorizing the Department of Health 174 to disclose certain confidential and exempt 175 information in the prescription drug monitoring 176 program’s database under certain circumstances 177 involving reciprocal agreements with other states; 178 prohibiting the sharing of information from the 179 prescription drug monitoring program’s database which 180 is not for the purpose that is statutorily authorized 181 or according to the State Surgeon General’s 182 determination of compatibility; amending s. 893.07, 183 F.S.; requiring that a person report to the local 184 sheriff’s office the theft or loss of a controlled 185 substance within a specified time; providing 186 penalties; providing legislative intent; amending s. 187 893.13, F.S.; prohibiting a person from obtaining or 188 attempting to obtain from a practitioner a controlled 189 substance or a prescription for a controlled substance 190 by misrepresentation, fraud, forgery, deception, 191 subterfuge, or concealment of a material fact; 192 prohibiting a health care provider from providing a 193 controlled substance or a prescription for a 194 controlled substance by misrepresentation, fraud, 195 forgery, deception, subterfuge, or concealment of a 196 material fact; prohibiting a person from adulterating 197 a controlled substance for certain use without 198 authorization by a prescribing physician; authorizing 199 a law enforcement officer to seize as evidence the 200 adulteration or off-label use of a prescribed 201 controlled substance; providing that such adulterated 202 or off-label use of the controlled substance may be 203 returned to its owner only under certain conditions; 204 providing penalties; prohibiting a prescribing 205 practitioner from writing a prescription for a 206 controlled substance and authorizing or directing the 207 adulteration of the dispensed form of the controlled 208 substance for the purpose of ingestion by means not 209 medically necessary; amending s. 893.138, F.S.; 210 providing circumstances in which a pain-management 211 clinic may be declared a public nuisance; providing 212 definitions; requiring the Board of Pharmacy to create 213 a list of opioid analgesic drugs; providing 214 requirements for the list of opioid analgesic drugs; 215 prohibiting a pharmacist from interchanging or 216 substituting an opioid analgesic drug, brand, or 217 generic for an opioid analgesic drug incorporating a 218 tamper-resistance technology unless certain 219 requirements are met; providing an effective date. 220 221 Be It Enacted by the Legislature of the State of Florida: 222 223 Section 1. Subsections (4) and (7) of section 400.9905, 224 Florida Statutes, are amended to read: 225 400.9905 Definitions.— 226 (4) “Clinic” means an entity at which health care services 227 are provided to individuals and which tenders charges for 228 reimbursement or payment for such services, including a mobile 229 clinic and a portable equipment provider. For purposes of this 230 part, the term does not include and the licensure requirements 231 of this part do not apply to: 232 (a) Entities licensed or registered by the state under 233 chapter 395; or entities licensed or registered by the state and 234 providing only health care services within the scope of services 235 authorized under their respective licenses granted under ss. 236 383.30-383.335, chapter 390, chapter 394, chapter 397, this 237 chapter except part X, chapter 429, chapter 463, chapter 465, 238 chapter 466, chapter 478, part I of chapter 483, chapter 484, or 239 chapter 651; end-stage renal disease providers authorized under 240 42 C.F.R. part 405, subpart U; or providers certified under 42 241 C.F.R. part 485, subpart B or subpart H; or any entity that 242 provides neonatal or pediatric hospital-based health care 243 services or other health care services by licensed practitioners 244 solely within a hospital licensed under chapter 395. 245 (b) Entities that own, directly or indirectly, entities 246 licensed or registered by the state pursuant to chapter 395; or 247 entities that own, directly or indirectly, entities licensed or 248 registered by the state and providing only health care services 249 within the scope of services authorized pursuant to their 250 respective licenses granted under ss. 383.30-383.335, chapter 251 390, chapter 394, chapter 397, this chapter except part X, 252 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, 253 part I of chapter 483, chapter 484, chapter 651; end-stage renal 254 disease providers authorized under 42 C.F.R. part 405, subpart 255 U; or providers certified under 42 C.F.R. part 485, subpart B or 256 subpart H; or any entity that provides neonatal or pediatric 257 hospital-based health care services by licensed practitioners 258 solely within a hospital licensed under chapter 395. 259 (c) Entities that are owned, directly or indirectly, by an 260 entity licensed or registered by the state pursuant to chapter 261 395; or entities that are owned, directly or indirectly, by an 262 entity licensed or registered by the state and providing only 263 health care services within the scope of services authorized 264 pursuant to their respective licenses granted under ss. 383.30 265 383.335, chapter 390, chapter 394, chapter 397, this chapter 266 except part X, chapter 429, chapter 463, chapter 465, chapter 267 466, chapter 478, part I of chapter 483, chapter 484, or chapter 268 651; end-stage renal disease providers authorized under 42 269 C.F.R. part 405, subpart U; or providers certified under 42 270 C.F.R. part 485, subpart B or subpart H; or any entity that 271 provides neonatal or pediatric hospital-based health care 272 services by licensed practitioners solely within a hospital 273 under chapter 395. 274 (d) Entities that are under common ownership, directly or 275 indirectly, with an entity licensed or registered by the state 276 pursuant to chapter 395; or entities that are under common 277 ownership, directly or indirectly, with an entity licensed or 278 registered by the state and providing only health care services 279 within the scope of services authorized pursuant to their 280 respective licenses granted under ss. 383.30-383.335, chapter 281 390, chapter 394, chapter 397, this chapter except part X, 282 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, 283 part I of chapter 483, chapter 484, or chapter 651; end-stage 284 renal disease providers authorized under 42 C.F.R. part 405, 285 subpart U; or providers certified under 42 C.F.R. part 485, 286 subpart B or subpart H; or any entity that provides neonatal or 287 pediatric hospital-based health care services by licensed 288 practitioners solely within a hospital licensed under chapter 289 395. 290 (e) An entity that is exempt from federal taxation under 26 291 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan 292 under 26 U.S.C. s. 409 that has a board of trustees not less 293 than two-thirds of which are Florida-licensed health care 294 practitioners and provides only physical therapy services under 295 physician orders, any community college or university clinic, 296 and any entity owned or operated by the federal or state 297 government, including agencies, subdivisions, or municipalities 298 thereof. 299 (f) A sole proprietorship, group practice, partnership, or 300 corporation that provides health care services by physicians 301 covered by s. 627.419, that is directly supervised by one or 302 more of such physicians, and that is wholly owned by one or more 303 of those physicians or by a physician and the spouse, parent, 304 child, or sibling of that physician. 305 (g) A sole proprietorship, group practice, partnership, or 306 corporation that provides health care services by licensed 307 health care practitioners under chapter 457, chapter 458, 308 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, 309 chapter 466, chapter 467, chapter 480, chapter 484, chapter 486, 310 chapter 490, chapter 491, or part I, part III, part X, part 311 XIII, or part XIV of chapter 468, or s. 464.012, which are 312 wholly owned by one or more licensed health care practitioners, 313 or the licensed health care practitioners set forth in this 314 paragraph and the spouse, parent, child, or sibling of a 315 licensed health care practitioner, so long as one of the owners 316 who is a licensed health care practitioner is supervising the 317 business activities and is legally responsible for the entity’s 318 compliance with all federal and state laws. However, a health 319 care practitioner may not supervise services beyond the scope of 320 the practitioner’s license, except that, for the purposes of 321 this part, a clinic owned by a licensee in s. 456.053(3)(b) that 322 provides only services authorized pursuant to s. 456.053(3)(b) 323 may be supervised by a licensee specified in s. 456.053(3)(b). 324 (h) Clinical facilities affiliated with an accredited 325 medical school at which training is provided for medical 326 students, residents, or fellows. 327 (i) Entities that provide only oncology or radiation 328 therapy services by physicians licensed under chapter 458 or 329 chapter 459 or entities that provide oncology or radiation 330 therapy services by physicians licensed under chapter 458 or 331 chapter 459 which are owned by a corporation whose shares are 332 publicly traded on a recognized stock exchange. 333 (j) Clinical facilities affiliated with a college of 334 chiropractic accredited by the Council on Chiropractic Education 335 at which training is provided for chiropractic students. 336 (k) Entities that provide licensed practitioners to staff 337 emergency departments or to deliver anesthesia services in 338 facilities licensed under chapter 395 and that derive at least 339 90 percent of their gross annual revenues from the provision of 340 such services. Entities claiming an exemption from licensure 341 under this paragraph must provide documentation demonstrating 342 compliance. 343 (l) Orthotic or prosthetic clinical facilities that are a 344 publicly traded corporation or that are wholly owned, directly 345 or indirectly, by a publicly traded corporation. As used in this 346 paragraph, a publicly traded corporation is a corporation that 347 issues securities traded on an exchange registered with the 348 United States Securities and Exchange Commission as a national 349 securities exchange. 350 (7) “Portable equipment provider” means an entity that 351 contracts with or employs persons to provide portable equipment 352 to multiple locations performing treatment or diagnostic testing 353 of individuals, that bills third-party payors for those354services,and that otherwise meets the definition of a clinic in 355 subsection (4). 356 Section 2. Subsection (7) of section 456.013, Florida 357 Statutes, is amended to read: 358 456.013 Department; general licensing provisions.— 359 (7)(a) The boards, or the department when there is no 360 board, shall require the completion of a 2-hour course relating 361 to prevention of medical errors as part of the licensure and 362 renewal process. The 2-hour course countsshall counttowards 363 the total number of continuing education hours required for the 364 profession. The board or department shall approve the course 365shall be approved by the board or department, as appropriate, 366 which mustand shallinclude a study of root-cause analysis, 367 error reduction and prevention, and patient safety. In addition, 368 the course approved by the Board of Medicine and the Board of 369 Osteopathic Medicine mustshallinclude information relating to 370 the five most misdiagnosed conditions during the previous 371 biennium, as determined by the board. If the course is being 372 offered by a facility licensed underpursuant tochapter 395 for 373 its employees, the board may approve up to 1 hour of the 2-hour 374 course to be specifically related to error reduction and 375 prevention methods used in that facility. 376 (b) As a condition of initial licensure and at each 377 subsequent license renewal, the boards, or the department if 378 there is no board, shall allow each practitioner licensed under 379 chapter 458, chapter 459, chapter 461, chapter 465, or chapter 380 466 whose lawful scope of practice authorizes the practitioner 381 to prescribe, administer, or dispense controlled substances to 382 complete a 1-hour continuing education course relating to the 383 prescription drug monitoring program. The course must include, 384 but need not be limited to: 385 1. The purpose of the prescription drug monitoring program. 386 2. The practitioners’ capabilities for improving the 387 standard of care for patients by using the prescription drug 388 monitoring program. 389 3. How the prescription drug monitoring program can help 390 practitioners detect doctor shopping. 391 4. The involvement of law enforcement personnel, the 392 Attorney General’s Medicaid Fraud Unit, and medical regulatory 393 investigators with the prescription drug monitoring program. 394 5. The procedures for registering for access to the 395 prescription drug monitoring program. 396 397 The course hours may be included in the total number of hours of 398 continuing education required by the profession and must be 399 approved by the board or by the department if there is no board. 400 The boards, or the department if there is no board, shall 401 approve the course offered through a facility licensed under 402 chapter 395 for its employees if the course is at least 3 hours 403 and covers the education requirements. 404 (c) The course requirements in paragraph (b) apply to each 405 licensee renewing his or her license on or after July 1, 2012, 406 and to each applicant approved for licensure on or after January 407 1, 2013. 408 (d) By October 1, 2011, the boards, or the department if 409 there is no board, shall adopt rules as necessary to administer 410 this subsection. 411 Section 3. Section 458.305, Florida Statutes, is amended to 412 read: 413 458.305 Definitions.—As used in this chapter: 414 (1) “Board” means the Board of Medicine. 415 (2) “Department” means the Department of Health. 416 (3) “Dispensing physician” means a physician who is 417 registered as a dispensing practitioner under s. 465.0276. 418 (4)(3)“Practice of medicine” means the diagnosis, 419 treatment, operation, or prescription for any human disease, 420 pain, injury, deformity, or other physical or mental condition. 421 (5)(4)“Physician” means a person who is licensed to 422 practice medicine in this state. 423 Section 4. Advertising of controlled substances by a 424 dispensing physician.— 425 (1)(a) Only a dispensing physician licensed under chapter 426 458 or chapter 459, Florida Statutes, may use the title 427 “dispensing physician” or “dispenser” or otherwise lead the 428 public to believe that he or she is engaged in the dispensing of 429 controlled substances. 430 (b) A person, other than an owner of a: 431 1. Pain-management clinic registered under chapter 458 or 432 chapter 459, Florida Statutes; or 433 2. Health clinic licensed under chapter 400, Florida 434 Statutes, 435 436 may not display any sign or take any other action that would 437 lead the public to believe that such person is engaged in the 438 business of dispensing a controlled substance. Any advertisement 439 that states “dispensing onsite” or “onsite pharmacy” violates 440 this paragraph. This paragraph does not preclude a person who is 441 not licensed as a medical practitioner from owning a pain 442 management clinic. 443 (c) A person, firm, or corporation, unless licensed under 444 chapter 465, Florida Statutes, may not use in a trade name, 445 sign, letter, or advertisement any term, including “drug,” 446 “pharmacy,” “onsite pharmacy,” “dispensing,” “dispensing 447 onsite,” “prescription drugs,” “Rx,” or “apothecary,” which 448 implies that the person, firm, or corporation is licensed or 449 registered to dispense prescription drugs in this state. 450 (2) A person who violates paragraph (1)(a) or paragraph 451 (1)(b) commits a misdemeanor of the first degree, punishable as 452 provided in s. 775.082 or s. 775.083, Florida Statutes. A person 453 who violates paragraph (1)(c) commits a felony of the third 454 degree, punishable as provided in s. 775.082, s. 775.083, or s. 455 775.084, Florida Statutes. In any warrant, information, or 456 indictment, it is not necessary to negate any exceptions, and 457 the burden of any exception is upon the defendant. 458 Section 5. Paragraph (a) of subsection (1) of section 459 458.3191, Florida Statutes, is amended to read: 460 458.3191 Physician survey.— 461 (1) Each person who applies for licensure renewal as a 462 physician under this chapter or chapter 459 must, in conjunction 463 with the renewal of such license under procedures adopted by the 464 Department of Health and in addition to any other information 465 that may be required from the applicant, furnish the following 466 to the Department of Health in a physician survey: 467 (a) Licensee information, including, but not limited to: 468 1. Frequency and geographic location of practice within the 469 state. 470 2. Practice setting. 471 3. Percentage of time spent in direct patient care. 472 4. Anticipated change to license or practice status. 473 5. Areas of specialty or certification. 474 6. Whether the department has ever approved or denied the 475 physician’s registration for access to a patient’s information 476 in the prescription drug monitoring program’s database. 477 7. Whether the physician uses the prescription drug 478 monitoring program with patients in his or her medical practice. 479 Section 6. Subsection (3) is added to section 458.3192, 480 Florida Statutes, to read: 481 458.3192 Analysis of survey results; report.— 482 (3) By November 1 each year, the Department of Health shall 483 provide nonidentifying information to the prescription drug 484 monitoring program’s Implementation and Oversight Task Force 485 regarding the number of physicians who are registered with the 486 prescription drug monitoring program and who also use the 487 database from the prescription drug monitoring program for their 488 patients in their medical practice. 489 Section 7. Paragraph (a) of subsection (1) and paragraphs 490 (a) and (c) of subsection (2) of section 458.3265, Florida 491 Statutes, are amended, and paragraphs (f) and (g) are added to 492 subsection (5) of that section, to read: 493 458.3265 Pain-management clinics.— 494 (1) REGISTRATION.— 495 (a) All privately owned pain-management clinics, 496 facilities, or offices, hereinafter referred to as “clinics,” 497 which advertise in any medium for any type of pain-management 498 services, or employ a physician who is primarily engaged in the 499 treatment of pain by prescribing or dispensing controlled 500 substance medications, must register with the department unless: 501 1. That clinic is licensed as a facility pursuant to 502 chapter 395; 503 2. The majority of the physicians who provide services in 504 the clinic primarily provide surgical services or interventional 505 pain procedures of the type routinely billed using surgical 506 codes; 507 3. The clinic is owned by a publicly held corporation whose 508 shares are traded on a national exchange or on the over-the 509 counter market and whose total assets at the end of the 510 corporation’s most recent fiscal quarter exceeded $50 million; 511 4. The clinic is affiliated with an accredited medical 512 school at which training is provided for medical students, 513 residents, or fellows; 514 5. The clinic does not prescribe or dispense controlled 515 substances for the treatment of pain; or 516 6. The clinic is owned by a corporate entity exempt from 517 federal taxation under 26 U.S.C. s. 501(c)(3). 518 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities 519 apply to any physician who provides professional services in a 520 pain-management clinic that is required to be registered in 521 subsection (1). 522 (a) A physician may not practice medicine in a pain 523 management clinic, as described in subsection (4), if:5241.the pain-management clinic is not registered with the 525 department as required by this section.; or5262. Effective July 1, 2012, the physician has not527successfully completed a pain-medicine fellowship that is528accredited by the Accreditation Council for Graduate Medical529Education or a pain-medicine residency that is accredited by the530Accreditation Council for Graduate Medical Education or, prior531to July 1, 2012, does not comply with rules adopted by the532board.533 534 Any physician who qualifies to practice medicine in a pain 535 management clinic pursuant to rules adopted by the Board of 536 Medicine as of July 1, 2012, may continue to practice medicine 537 in a pain-management clinic as long as the physician continues 538 to meet the qualifications set forth in the board rules. A 539 physician who violates this paragraph is subject to disciplinary 540 action by his or her appropriate medical regulatory board. 541 (c) A physician, an advanced registered nurse practitioner, 542 or a physician assistant must perform an appropriate medicala543physicalexamination of a patient on the same day that the 544 physicianhe or shedispenses or prescribes a controlled 545 substance to a patient at a pain-management clinic. If the 546 physician prescribes or dispenses more than a 72-hour dose of 547 controlled substances for the treatment of chronic nonmalignant 548 pain, the physician must document in the patient’s record the 549 reason such dosage is within the standard of care. For the 550 purpose of this paragraph, the standard of care is set forth in 551 rule 64B8-9.013(3), Florida Administrative Codefor prescribing552or dispensing that quantity. 553 (5) PENALTIES; ENFORCEMENT.— 554 (f) A licensee or other person who serves as the designated 555 physician of a pain-management clinic as defined in this section 556 or s. 459.0137 and registers a pain-management clinic through 557 misrepresentation or fraud or procures or attempts to procure 558 the registration of a pain-management clinic for any other 559 person by making or causing to be made any false or fraudulent 560 representation commits a felony of the third degree, punishable 561 as provided in s. 775.082, s. 775.083, or s. 775.084. 562 (g) Any person who registers a pain-management clinic 563 through misrepresentation or fraud or who procures or attempts 564 to procure the registration of a pain-management clinic for any 565 other person by making or causing to be made any false or 566 fraudulent representation, commits a felony of the third degree, 567 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 568 Section 8. Paragraphs (f) and (g) are added to subsection 569 (1), paragraphs (g) and (h) are added to subsection (2), and 570 subsection (3) is added to section 458.327, Florida Statutes, to 571 read: 572 458.327 Penalty for violations.— 573 (1) Each of the following acts constitutes a felony of the 574 third degree, punishable as provided in s. 775.082, s. 775.083, 575 or s. 775.084: 576 (f) Failing to perform a physical examination of a patient 577 by a physician or a licensed designee acting under the 578 physician’s supervision on the same day that the treating 579 physician dispenses or prescribes a controlled substance to the 580 patient at a pain-management clinic occurring three or more 581 times within a 6-month period, or failing to perform a physical 582 examination on three or more different patients on the same day 583 that the treating physician dispenses or prescribes a controlled 584 substance to each patient at a pain-management clinic within a 585 6-month period. 586 (g) Prescribing or dispensing in excess of a 72-hour dose 587 of controlled substances at a pain-management clinic for the 588 treatment of chronic nonmalignant pain of a patient occurring 589 three or more times within a 6-month period without documenting 590 in the patient’s record the reason that such dosage is within 591 the standard of care. For the purpose of this paragraph, the 592 standard of care is set forth in rule 64B8-9.013(3), Florida 593 Administrative Code. 594 (2) Each of the following acts constitutes a misdemeanor of 595 the first degree, punishable as provided in s. 775.082 or s. 596 775.083: 597 (g) Failing to perform a physical examination of a patient 598 on the same day that the treating physician dispenses or 599 prescribes a controlled substance to the patient at a pain 600 management clinic two times in a 6-month period, or failing to 601 perform a physical examination on two different patients on the 602 same day that the treating physician dispenses or prescribes a 603 controlled substance to each patient at a pain-management clinic 604 within a 6-month period. 605 (h) Prescribing or dispensing in excess of a 72-hour dose 606 of controlled substances at a pain-management clinic for the 607 treatment of chronic nonmalignant pain of a patient occurring 608 two times within a 6-month period without documenting in the 609 patient’s record the reason that such dosage is within the 610 standard of care. For the purpose of this paragraph, the 611 standard of care is set forth in rule 64B8-9.013(3), Florida 612 Administrative Code. 613 (3) Each of the following acts constitutes a misdemeanor of 614 the second degree, punishable as provided in s. 775.082 or s. 615 775.083: 616 (a) A first offense of failing to perform a physical 617 examination of a patient on the same day that the treating 618 physician dispenses or prescribes a controlled substance to the 619 patient at a pain-management clinic. 620 (b) A first offense of failing to document in a patient’s 621 record the reason that such dosage is within the standard of 622 care for prescribing or dispensing in excess of a 72-hour dose 623 of controlled substances at a pain-management clinic for the 624 treatment of chronic nonmalignant pain. 625 Section 9. Subsection (11) is added to section 458.331, 626 Florida Statutes, to read: 627 458.331 Grounds for disciplinary action; action by the 628 board and department.— 629 (11) Notwithstanding subsection (2), upon finding that a 630 physician has prescribed or dispensed, or caused to be 631 prescribed or dispensed, a controlled substance in a pain 632 management clinic in a manner that violates the standard of 633 practice as set forth in this chapter or rules adopted pursuant 634 to this chapter, the board shall, at a minimum, suspend the 635 physician’s license for at least 6 months and impose a fine of 636 at least $10,000 per count. Repeated violations shall result in 637 increased penalties. 638 Section 10. Present subsections (3), (4), and (5) of 639 section 459.003, Florida Statutes, are redesignated as 640 subsections (4), (5), and (6), respectively, and a new 641 subsection (3) is added to that section, to read: 642 459.003 Definitions.—As used in this chapter: 643 (3) “Dispensing physician” means an osteopathic physician 644 who is registered as a dispensing practitioner under s. 645 465.0276. 646 Section 11. Paragraphs (f) and (g) are added to subsection 647 (1), paragraphs (e) and (f) are added to subsection (2), and 648 paragraphs (d) and (e) are added to subsection (3) of section 649 459.013, Florida Statutes, to read: 650 459.013 Penalty for violations.— 651 (1) Each of the following acts constitutes a felony of the 652 third degree, punishable as provided in s. 775.082, s. 775.083, 653 or s. 775.084: 654 (f) Failing to perform a physical examination of a patient 655 on the same day that the osteopathic physician dispenses or 656 prescribes a controlled substance to the patient at a pain 657 management clinic occurring three or more times within a 6-month 658 period, or failing to perform a physical examination on three or 659 more different patients on the same day that the osteopathic 660 physician dispenses or prescribes a controlled substance to each 661 patient at a pain-management clinic within a 6-month period. 662 (g) Prescribing or dispensing in excess of a 72-hour dose 663 of controlled substances at a pain-management clinic for the 664 treatment of chronic nonmalignant pain of a patient occurring 665 three or more times within a 6-month period without documenting 666 in the patient’s record the reason that such dosage is within 667 the standard of care. For the purpose of this paragraph, the 668 standard of care is set forth in rule 64B8-9.013(3), Florida 669 Administrative Code. 670 (2) Each of the following acts constitutes a misdemeanor of 671 the first degree, punishable as provided in s. 775.082 or s. 672 775.083: 673 (e) Failing to perform a physical examination of a patient 674 on the same day that the osteopathic physician dispenses or 675 prescribes a controlled substance to the patient at a pain 676 management clinic occurring two times within a 6-month period, 677 or failing to perform a physical examination on two different 678 patients on the same day that the osteopathic physician 679 dispenses or prescribes a controlled substance to each patient 680 at a pain-management clinic within a 6-month period. 681 (f) Prescribing or dispensing in excess of a 72-hour dose 682 of controlled substances at a pain-management clinic for the 683 treatment of chronic nonmalignant pain of a patient occurring 684 two times within a 6-month period without documenting in the 685 patient’s record the reason that such dosage is within the 686 standard of care. For the purpose of this paragraph, the 687 standard of care is set forth in rule 64B8-9.013(3), Florida 688 Administrative Code. 689 (3) Each of the following constitutes a misdemeanor of the 690 second degree, punishable as provided in s. 775.082 or s. 691 775.083: 692 (d) A first offense of failing to perform a physical 693 examination of a patient on the same day that the osteopathic 694 physician dispenses or prescribes a controlled substance to the 695 patient at a pain-management clinic. 696 (e) A first offense of failing to document in a patient’s 697 record the reason that such dosage is within the standard of 698 care for prescribing or dispensing in excess of a 72-hour dose 699 of controlled substances at a pain-management clinic for the 700 treatment of chronic nonmalignant pain. For the purpose of this 701 paragraph, the standard of care is set forth in rule 64B8 702 9.013(3), Florida Administrative Code. 703 Section 12. Paragraph (a) of subsection (1) and paragraph 704 (c) of subsection (2) of section 459.0137, Florida Statutes, are 705 amended, and paragraphs (f) and (g) are added to subsection (5) 706 of that section, to read: 707 459.0137 Pain-management clinics.— 708 (1) REGISTRATION.— 709 (a) All privately owned pain-management clinics, 710 facilities, or offices, hereinafter referred to as “clinics,” 711 which advertise in any medium for any type of pain-management 712 services, or employ an osteopathic physician who is primarily 713 engaged in the treatment of pain by prescribing or dispensing 714 controlled substance medications, must register with the 715 department unless: 716 1. That clinic is licensed as a facility pursuant to 717 chapter 395; 718 2. The majority of the physicians who provide services in 719 the clinic primarily provide surgical services or interventional 720 pain procedures of the type routinely billed using surgical 721 codes; 722 3. The clinic is owned by a publicly held corporation whose 723 shares are traded on a national exchange or on the over-the 724 counter market and whose total assets at the end of the 725 corporation’s most recent fiscal quarter exceeded $50 million; 726 4. The clinic is affiliated with an accredited medical 727 school at which training is provided for medical students, 728 residents, or fellows; 729 5. The clinic does not prescribe or dispense controlled 730 substances for the treatment of pain; or 731 6. The clinic is owned by a corporate entity exempt from 732 federal taxation under 26 U.S.C. s. 501(c)(3). 733 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities 734 apply to any osteopathic physician who provides professional 735 services in a pain-management clinic that is required to be 736 registered in subsection (1). 737 (c) An osteopathic physician, an advanced registered nurse 738 practitioner, or a physician assistant must perform an 739 appropriate medicala physicalexamination of a patient on the 740 same day that the physicianhe or shedispenses or prescribes a 741 controlled substance to a patient at a pain-management clinic. 742 If the osteopathic physician prescribes or dispenses more than a 743 72-hour dose of controlled substances for the treatment of 744 chronic nonmalignant pain, the osteopathic physician must 745 document in the patient’s record the reason for which 746 prescribing or dispensing a dosage in excess of a 72-hour dose 747 of controlled substances for the treatment of chronic 748 nonmalignant pain is within the standard of carefor prescribing749or dispensing that quantity. 750 (5) PENALTIES; ENFORCEMENT.— 751 (f) A licensee or other person who serves as the designated 752 physician of a pain-management clinic as defined in s. 458.3265 753 or s. 459.0137 and registers a pain-management clinic through 754 intentional misrepresentation or fraud or procures or attempts 755 to procure the registration of a pain-management clinic for any 756 other person by making or causing to be made any false or 757 fraudulent representation commits a felony of the third degree, 758 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 759 (g) Any person who registers a pain-management clinic 760 through misrepresentation or fraud or who procures or attempts 761 to procure the registration of a pain-management clinic for any 762 other person by making or causing to be made any false or 763 fraudulent representation, commits a felony of the third degree, 764 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 765 Section 13. Subsection (11) is added to section 459.015, 766 Florida Statutes, to read: 767 459.015 Grounds for disciplinary action; action by the 768 board and department.— 769 (11) Notwithstanding subsection (2), upon finding that an 770 osteopathic physician has prescribed or dispensed, or caused to 771 be prescribed or dispensed, a controlled substance in a pain 772 management clinic in a manner that violates the standard of 773 practice as set forth in this chapter or rules adopted pursuant 774 to this chapter, the board shall, at a minimum, suspend the 775 osteopathic physician’s license for at least 6 months and impose 776 a fine of at least $10,000 per count. Repeated violations shall 777 result in increased penalties. 778 Section 14. Present subsections (3) and (4) of section 779 465.015, Florida Statutes, are renumbered as subsections (4) and 780 (5), respectively, and a new subsection (3) is added to that 781 section, to read: 782 465.015 Violations and penalties.— 783 (3)(a) A licensed pharmacist, pharmacy technician, or any 784 person working under the direction or supervision of a 785 pharmacist or pharmacy technician, may not knowingly fail to 786 timely report to the local county sheriff’s office the name of 787 any person who obtains or attempts to obtain a substance 788 controlled by s. 893.03 which the pharmacist, pharmacy intern, 789 or other person employed by or at a pharmacy knows or reasonably 790 should have known was obtained or attempted to be obtained from 791 the pharmacy through any fraudulent method or representation. A 792 pharmacist, pharmacy intern, or other person employed by or at a 793 pharmacy who fails to make such a report within 24 hours after 794 learning of the fraud or attempted fraud commits a misdemeanor 795 of the first degree, punishable as provided in s. 775.082 or s. 796 775.083. 797 (b) A sufficient report of the fraudulent obtaining of or 798 attempt to obtain a controlled substance under this section must 799 contain, at a minimum, a copy of the prescription used or 800 presented and a narrative, including all information available 801 to the pharmacy regarding: 802 1. The transaction, such as the name and telephone number 803 of the prescribing physician; 804 2. The name, description, and any personal identification 805 information pertaining to the person presenting the 806 prescription; and 807 3. All other material information, such as photographic or 808 video surveillance of the transaction. 809 810 A pharmacist, pharmacy intern, or other person employed by or at 811 a pharmacy is not subject to disciplinary action for reporting 812 under this subsection. 813 Section 15. Subsection (6) is added to section 465.0276, 814 Florida Statutes, to read: 815 465.0276 Dispensing practitioner.— 816 (6) In order to dispense a controlled substance listed in 817 Schedule II, Schedule III, or Schedule IV in s. 893.03, a 818 practitioner authorized by law to prescribe a controlled 819 substance shall register with the Board of Pharmacy as a 820 dispensing practitioner who dispenses controlled substances and 821 pay a fee not to exceed $100. The department shall adopt rules 822 establishing procedures for renewal of the registration every 4 823 years. 824 Section 16. Paragraph (a) of subsection (1) of section 825 766.101, Florida Statutes, is amended to read: 826 766.101 Medical review committee, immunity from liability.— 827 (1) As used in this section: 828 (a) The term “medical review committee” or “committee” 829 means: 830 1.a. A committee of a hospital or ambulatory surgical 831 center licensed under chapter 395 or a health maintenance 832 organization certificated under part I of chapter 641, 833 b. A committee of a physician-hospital organization, a 834 provider-sponsored organization, or an integrated delivery 835 system, 836 c. A committee of a state or local professional society of 837 health care providers, 838 d. A committee of a medical staff of a licensed hospital or 839 nursing home, provided the medical staff operates pursuant to 840 written bylaws that have been approved by the governing board of 841 the hospital or nursing home, 842 e. A committee of the Department of Corrections or the 843 Correctional Medical Authority as created under s. 945.602, or 844 employees, agents, or consultants of either the department or 845 the authority or both, 846 f. A committee of a professional service corporation formed 847 under chapter 621 or a corporation organized under chapter 607 848 or chapter 617, which is formed and operated for the practice of 849 medicine as defined in s. 458.305(4)s.458.305(3), and which 850 has at least 25 health care providers who routinely provide 851 health care services directly to patients, 852 g. A committee of the Department of Children and Family 853 Services which includes employees, agents, or consultants to the 854 department as deemed necessary to provide peer review, 855 utilization review, and mortality review of treatment services 856 provided pursuant to chapters 394, 397, and 916, 857 h. A committee of a mental health treatment facility 858 licensed under chapter 394 or a community mental health center 859 as defined in s. 394.907, provided the quality assurance program 860 operates pursuant to the guidelines which have been approved by 861 the governing board of the agency, 862 i. A committee of a substance abuse treatment and education 863 prevention program licensed under chapter 397 provided the 864 quality assurance program operates pursuant to the guidelines 865 which have been approved by the governing board of the agency, 866 j. A peer review or utilization review committee organized 867 under chapter 440, 868 k. A committee of the Department of Health, a county health 869 department, healthy start coalition, or certified rural health 870 network, when reviewing quality of care, or employees of these 871 entities when reviewing mortality records, or 872 l. A continuous quality improvement committee of a pharmacy 873 licensed pursuant to chapter 465, 874 875 which committee is formed to evaluate and improve the quality of 876 health care rendered by providers of health service, to 877 determine that health services rendered were professionally 878 indicated or were performed in compliance with the applicable 879 standard of care, or that the cost of health care rendered was 880 considered reasonable by the providers of professional health 881 services in the area; or 882 2. A committee of an insurer, self-insurer, or joint 883 underwriting association of medical malpractice insurance, or 884 other persons conducting review under s. 766.106. 885 Section 17. Subsection (3) of section 810.02, Florida 886 Statutes, is amended to read: 887 810.02 Burglary.— 888 (3) Burglary is a felony of the second degree, punishable 889 as provided in s. 775.082, s. 775.083, or s. 775.084, if, in the 890 course of committing the offense, the offender does not make an 891 assault or battery and is not and does not become armed with a 892 dangerous weapon or explosive, and the offender enters or 893 remains in a: 894 (a) Dwelling, and there is another person in the dwelling 895 at the time the offender enters or remains; 896 (b) Dwelling, and there is not another person in the 897 dwelling at the time the offender enters or remains; 898 (c) Structure, and there is another person in the structure 899 at the time the offender enters or remains; 900 (d) Conveyance, and there is another person in the 901 conveyance at the time the offender enters or remains;or902 (e) Authorized emergency vehicle, as defined in s. 316.003; 903 or.904 (f) Structure or conveyance when the offense intended to be 905 committed is theft of a substance controlled by s. 893.03. 906 Notwithstanding any contrary provisions of law, separate 907 judgments and sentences for burglary with the intent to commit 908 theft of a controlled substance under this paragraph and for any 909 applicable offense for possession of a controlled substance 910 under s. 893.13, or an offense for trafficking in a controlled 911 substance under s. 893.135, may be imposed if all such offenses 912 involve the same amount or amounts of a controlled substance. 913 914 However, if the burglary is committed within a county that is 915 subject to a state of emergency declared by the Governor under 916 chapter 252 after the declaration of emergency is made and the 917 perpetration of the burglary is facilitated by conditions 918 arising from the emergency, the burglary is a felony of the 919 first degree, punishable as provided in s. 775.082, s. 775.083, 920 or s. 775.084. As used in this subsection, the term “conditions 921 arising from the emergency” means civil unrest, power outages, 922 curfews, voluntary or mandatory evacuations, or a reduction in 923 the presence of or response time for first responders or 924 homeland security personnel. A person arrested for committing a 925 burglary within a county that is subject to such a state of 926 emergency may not be released until the person appears before a 927 committing magistrate at a first appearance hearing. For 928 purposes of sentencing under chapter 921, a felony offense that 929 is reclassified under this subsection is ranked one level above 930 the ranking under s. 921.0022 or s. 921.0023 of the offense 931 committed. 932 Section 18. Paragraph (c) of subsection (2) of section 933 812.014, Florida Statutes, is amended to read: 934 812.014 Theft.— 935 (2) 936 (c) It is grand theft of the third degree and a felony of 937 the third degree, punishable as provided in s. 775.082, s. 938 775.083, or s. 775.084, if the property stolen is: 939 1. Valued at $300 or more, but less than $5,000. 940 2. Valued at $5,000 or more, but less than $10,000. 941 3. Valued at $10,000 or more, but less than $20,000. 942 4. A will, codicil, or other testamentary instrument. 943 5. A firearm. 944 6. A motor vehicle, except as provided in paragraph (a). 945 7. Any commercially farmed animal, including any animal of 946 the equine, bovine, or swine class, or other grazing animal, and 947 including aquaculture species raised at a certified aquaculture 948 facility. If the property stolen is aquaculture species raised 949 at a certified aquaculture facility, then a $10,000 fine shall 950 be imposed. 951 8. Any fire extinguisher. 952 9. Any amount of citrus fruit consisting of 2,000 or more 953 individual pieces of fruit. 954 10. Taken from a designated construction site identified by 955 the posting of a sign as provided for in s. 810.09(2)(d). 956 11. Any stop sign. 957 12. Anhydrous ammonia. 958 13. Any amount of a substance controlled by s. 893.03. 959 Notwithstanding any contrary provisions of law, separate 960 judgments and sentences for theft of a controlled substance 961 under this subparagraph, and for any applicable offense for 962 possession of a controlled substance under s. 893.13, or an 963 offense for trafficking in a controlled substance under s. 964 893.135 may be imposed if all such offenses involve the same 965 amount or amounts of controlled substance. 966 967 However, if the property is stolen within a county that is 968 subject to a state of emergency declared by the Governor under 969 chapter 252, the property is stolen after the declaration of 970 emergency is made, and the perpetration of the theft is 971 facilitated by conditions arising from the emergency, the 972 offender commits a felony of the second degree, punishable as 973 provided in s. 775.082, s. 775.083, or s. 775.084, if the 974 property is valued at $5,000 or more, but less than $10,000, as 975 provided under subparagraph 2., or if the property is valued at 976 $10,000 or more, but less than $20,000, as provided under 977 subparagraph 3. As used in this paragraph, the term “conditions 978 arising from the emergency” means civil unrest, power outages, 979 curfews, voluntary or mandatory evacuations, or a reduction in 980 the presence of or the response time for first responders or 981 homeland security personnel. For purposes of sentencing under 982 chapter 921, a felony offense that is reclassified under this 983 paragraph is ranked one level above the ranking under s. 984 921.0022 or s. 921.0023 of the offense committed. 985 Section 19. Section 893.021, Florida Statutes, is created 986 to read: 987 893.021 Adulterated drug.— 988 (1) As used in this chapter, a drug is adulterated if it is 989 a controlled substance that: 990 (a) Has been produced, prepared, packed, and marketed for 991 oral consumption by the manufacturer; and 992 (b) Has had any change to its integrity or composition for 993 use by means of inhalation, injection, or any other form of 994 ingestion not in accordance with the manufacturer’s recommended 995 use, and such mode of use has not been previously directed and 996 approved by the prescribing physician. 997 (2) A physician is not prevented from directing or 998 prescribing a change to the recognized manufactured 999 recommendations for use in a patient who presents a medical need 1000 for such a requirement change of any controlled substance. The 1001 prescribing physician shall clearly indicate any deviation of 1002 the recognized manufacturer’s recommended use of a controlled 1003 substance on the original prescription, and the licensed 1004 pharmacist shall clearly indicate such deviation on the label of 1005 the prescription upon dispensing the controlled substance. 1006 Section 20. Paragraphs (c), (d), and (e) of subsection (1) 1007 of section 893.04, Florida Statutes, are amended to read: 1008 893.04 Pharmacist and practitioner.— 1009 (1) A pharmacist, in good faith and in the course of 1010 professional practice only, may dispense controlled substances 1011 upon a written or oral prescription of a practitioner, under the 1012 following conditions: 1013 (c) The following information mustThere shallappear on 1014 the face of the prescription or written record of athereof for1015thecontrolled substancethe following information: 1016 1. The full name and address of the person for whom, or the 1017 owner of the animal for which, the controlled substance is 1018 dispensed. 1019 2. The full name and address of the prescribing 1020 practitioner and the practitioner’s federal controlled substance 1021 registry number shall be printed thereon. 1022 3. If the prescription is for an animal, the species of 1023 animal for which the controlled substance is prescribed. 1024 4. The name of the controlled substance prescribed and the 1025 strength, quantity, and directions for use thereof. The 1026 directions for use must specify the authorization by the 1027 physician, any instructions requiring the adulteration of the 1028 dispensed form of the medication, and the medical necessity for 1029 the adulteration in accordance with s. 893.021. 1030 5. The number of the prescription, as recorded in the 1031 prescription files of the pharmacy in which it is filled. 1032 6. The initials of the pharmacist filling the prescription 1033 and the date filled. 1034 (d) The prescription mustshallbe retained on file by the 1035 proprietor of the pharmacy in which it is filled for a period of 1036 2 years. 1037 (e) A label bearing the following information must be 1038 affixed to the original container in which a controlled 1039 substance is delivered asupona prescription or authorized 1040 refillthereof, as hereinafter provided, there shall be a label1041bearing the following information: 1042 1. The name and address of the pharmacy from which such 1043 controlled substance was dispensed. 1044 2. The date on which the prescription for such controlled 1045 substance was filled. 1046 3. The number of such prescription, as recorded in the 1047 prescription files of the pharmacy in which it is filled. 1048 4. The name of the prescribing practitioner. 1049 5. The name of the patient for whom, or of the owner and 1050 species of the animal for which, the controlled substance is 1051 prescribed. 1052 6. The directions for the use of the controlled substance 1053 prescribed in the prescription. 1054 7. A clear, concise warning that it is a crime to transfer 1055 the controlled substance to any person other than the patient 1056 for whom prescribed. 1057 Section 21. Section 893.055, Florida Statutes, is amended 1058 to read: 1059 893.055 Prescription drug monitoring program.— 1060 (1) As used in this section, the term: 1061 (a) “Patient advisory report” or “advisory report” means 1062 information provided by the department in writing, or as 1063 determined by the department, to a prescriber, dispenser, 1064 pharmacy, or patient concerning the dispensing of controlled 1065 substances. All advisory reports are for informational purposes 1066 only and impose no obligations of any nature or any legal duty 1067 on a prescriber, dispenser, pharmacy, or patient. The patient 1068 advisory report shall be provided in accordance with s. 1069 893.13(7)(a)8. The advisory reports issued by the department are 1070 not subject to discovery or introduction into evidence in any 1071 civil or administrative action against a prescriber, dispenser, 1072 pharmacy, or patient arising out of matters that are the subject 1073 of the report; and a person who participates in preparing, 1074 reviewing, issuing, or any other activity related to an advisory 1075 report may not be permitted or required to testify in any such 1076 civil action as to any findings, recommendations, evaluations, 1077 opinions, or other actions taken in connection with preparing, 1078 reviewing, or issuing such a report. 1079 (b) “Controlled substance” means a controlled substance 1080 listed in Schedule II, Schedule III, or Schedule IV in s. 1081 893.03. 1082 (c) “Dispenser” means a pharmacy, dispensing pharmacist, or 1083 dispensing health care practitioner. 1084 (d) “Health care practitioner” or “practitioner” means any 1085 practitioner who is subject to licensure or regulation by the 1086 department under chapter 458, chapter 459, chapter 461, chapter 1087 462, chapter 464, chapter 465, or chapter 466. 1088 (e) “Health care regulatory board” means any board for a 1089 practitioner or health care practitioner who is licensed or 1090 regulated by the department. 1091 (f) “Pharmacy” means any pharmacy that is subject to 1092 licensure or regulation by the department under chapter 465 and 1093 that dispenses or delivers a controlled substance to an 1094 individual or address in this state. 1095 (g) “Prescriber” means a prescribing physician, prescribing 1096 practitioner, or other prescribing health care practitioner. 1097 (h) “Active investigation” means an investigation that is 1098 being conducted with a reasonable, good faith belief that it 1099 could lead to the filing of administrative, civil, or criminal 1100 proceedings, or that is ongoing and continuing and for which 1101 there is a reasonable, good faith anticipation of securing an 1102 arrest or prosecution in the foreseeable future. 1103 (i) “Law enforcement agency” means the Department of Law 1104 Enforcement, a Florida sheriff’s department, a Florida police 1105 department, or a law enforcement agency of the Federal 1106 Government which enforces the laws of this state or the United 1107 States relating to controlled substances, and which its agents 1108 and officers are empowered by law to conduct criminal 1109 investigations and make arrests. 1110 (j) “Program manager” means an employee of or a person 1111 contracted by the Department of Health who is designated to 1112 ensure the integrity of the prescription drug monitoring program 1113 in accordance with the requirements established in paragraphs 1114 (2)(a) and (b). 1115 (2)(a) By December 1, 2010, the department shall design and 1116 establish a comprehensive electronic database system that has 1117 controlled substance prescriptions provided to it and that 1118 provides prescription information to a patient’s health care 1119 practitioner and pharmacist who inform the department that they 1120 wish the patient advisory report provided to them. Otherwise, 1121 the patient advisory report will not be sent to the 1122 practitioner, pharmacy, or pharmacist. The system shall be 1123 designed to provide information regarding dispensed 1124 prescriptions of controlled substances and shall not infringe 1125 upon the legitimate prescribing or dispensing of a controlled 1126 substance by a prescriber or dispenser acting in good faith and 1127 in the course of professional practice. The system shall be 1128 consistent with standards of the American Society for Automation 1129 in Pharmacy (ASAP). The electronic system shall also comply with 1130 the Health Insurance Portability and Accountability Act (HIPAA) 1131 as it pertains to protected health information (PHI), electronic 1132 protected health information (EPHI), the National All Schedules 1133 Prescription Electronic Reporting (NASPER) Act’s minimum 1134 requirements for authentication of a practitioner who requests 1135 information in the prescription drug monitoring program database 1136 and certification of the purpose for which information is 1137 requested, and all other relevant state and federal privacy and 1138 security laws and regulations. The department shall establish 1139 policies and procedures as appropriate regarding the reporting, 1140 accessing the database, evaluation, management, development, 1141 implementation, operation, storage, and security of information 1142 within the system. The reporting of prescribed controlled 1143 substances shall include a dispensing transaction with a 1144 dispenser pursuant to chapter 465 or through a dispensing 1145 transaction to an individual or address in this state with a 1146 pharmacy that is not located in this state but that is otherwise 1147 subject to the jurisdiction of this state as to that dispensing 1148 transaction. The reporting of patient advisory reports refers 1149 only to reports to patients, pharmacies, and practitioners. 1150 Separate reports that contain patient prescription history 1151 information and that are not patient advisory reports are 1152 provided to persons and entities as authorized in paragraphs 1153 (7)(b) and (c) and s. 893.0551. 1154 (b) The department, when the direct support organization 1155 receives at least $20,000 in nonstate moneys or the state 1156 receives at least $20,000 in federal grants for the prescription 1157 drug monitoring program, and in consultation with the Office of 1158 Drug Control, shall adopt rules as necessary concerning the 1159 reporting, accessing the database, evaluation, management, 1160 development, implementation, operation, security, and storage of 1161 information within the system, including rules for when patient 1162 advisory reports are provided to pharmacies and prescribers. The 1163 patient advisory report shall be provided in accordance with s. 1164 893.13(7)(a)8. The department shall work with the professional 1165 health care licensure boards, such as the Board of Medicine, the 1166 Board of Osteopathic Medicine, and the Board of Pharmacy; other 1167 appropriate organizations, such as the Florida Pharmacy 1168 Association, the Office of Drug Control, the Florida Medical 1169 Association, the Florida Retail Federation, and the Florida 1170 Osteopathic Medical Association, including those relating to 1171 pain management; and the Attorney General, the Department of Law 1172 Enforcement, and the Agency for Health Care Administration to 1173 develop rules appropriate for the prescription drug monitoring 1174 program. 1175 (c) All dispensers and prescribers subject to these 1176 reporting requirements shall be notified by the department of 1177 the implementation date for such reporting requirements. 1178 (d) The program manager shall work with professional health 1179 care licensure boards and the stakeholders listed in paragraph 1180 (b) to develop rules appropriate for identifying indicators of 1181 controlled substance abuse. 1182 (e) The department shall establish a method to allow 1183 corrections to the database when notified by a health care 1184 practitioner or pharmacist. 1185 (3) The pharmacy dispensing the controlled substance and 1186 each prescriber who directly dispenses a controlled substance 1187 shall submit to the electronic system, by a procedure and in a 1188 format established by the department and consistent with an 1189 ASAP-approved format, the following information for inclusion in 1190 the database: 1191 (a) The name of the prescribing practitioner, the 1192 practitioner’s federal Drug Enforcement Administration 1193 registration number, the practitioner’s National Provider 1194 Identification (NPI) or other appropriate identifier, and the 1195 date of the prescription. 1196 (b) The date the prescription was filled and the method of 1197 payment, such as cash by an individual, insurance coverage 1198 through a third party, or Medicaid payment. This paragraph does 1199 not authorize the department to include individual credit card 1200 numbers or other account numbers in the database. 1201 (c) The full name, address, and date of birth of the person 1202 for whom the prescription was written. 1203 (d) The name, national drug code, quantity, and strength of 1204 the controlled substance dispensed. 1205 (e) The full name, federal Drug Enforcement Administration 1206 registration number, and address of the pharmacy or other 1207 location from which the controlled substance was dispensed. If 1208 the controlled substance was dispensed by a practitioner other 1209 than a pharmacist, the practitioner’s full name, federal Drug 1210 Enforcement Administration registration number, and address. 1211 (f) The name of the pharmacy or practitioner, other than a 1212 pharmacist, dispensing the controlled substance and the 1213 practitioner’s National Provider Identification (NPI). 1214 (g) Other appropriate identifying information as determined 1215 by department rule. 1216 (h) The number of refills ordered and whether the drug was 1217 dispensed as a refill of a prescription or was a first-time 1218 request. 1219 (4) Each time a controlled substance is dispensed to an 1220 individual, the controlled substance shall be reported to the 1221 department through the system as soon thereafter as possible, 1222 but not more than 715days after the date the controlled 1223 substance is dispensed unless an extension is approved by the 1224 department for cause as determined by rule. A dispenser must 1225 meet the reporting requirements of this section by providing the 1226 required information concerning each controlled substance that 1227 it dispensed in a department-approved, secure methodology and 1228 format. Such approved formats may include, but are not limited 1229 to, submission via the Internet, on a disc, or by use of regular 1230 mail. 1231 (5) When the following acts of dispensing or administering 1232 occur, the following are exempt from reporting under this 1233 section for that specific act of dispensing or administration: 1234 (a) A health care practitioner when administering a 1235 controlled substance directly to a patient if the amount of the 1236 controlled substance is adequate to treat the patient during 1237 that particular treatment session. 1238 (b) A pharmacist or health care practitioner when 1239 administering a controlled substance to a patient or resident 1240 receiving care as a patient at a hospital, nursing home, 1241 ambulatory surgical center, hospice, or intermediate care 1242 facility for the developmentally disabled which is licensed in 1243 this state. 1244(c) A practitioner when administering or dispensing a1245controlled substance in the health care system of the Department1246of Corrections.1247 (c)(d)A practitioner when administering a controlled 1248 substance in the emergency room of a licensed hospital. 1249 (d)(e)A health care practitioner when administering or 1250 dispensing a controlled substance to a person under the age of 1251 16 if the amount of the controlled substance is adequate to 1252 treat the patient during that particular treatment session. 1253 (e)(f)A pharmacist or a dispensing practitioner when 1254 dispensing a one-time, 48-hour72-houremergency resupply of a 1255 controlled substance to a patient. 1256 (6) The department may establish when to suspend and when 1257 to resume reporting information during a state-declared or 1258 nationally declared disaster. 1259 (7)(a) A practitioner or pharmacist who dispenses a 1260 controlled substance must submit the information required by 1261 this section in an electronic or other method in an ASAP format 1262 approved by rule of the department unless otherwise provided in 1263 this section. The cost to the dispenser in submitting the 1264 information required by this section may not be material or 1265 extraordinary. Costs not considered to be material or 1266 extraordinary include, but are not limited to, regular postage, 1267 electronic media, regular electronic mail, and facsimile 1268 charges. 1269 (b)1. In order for a pharmacy, prescriber, practitioner, or 1270 dispenser toshallhave access to information in the 1271 prescription drug monitoring program’s database which relates to 1272 a patient of that pharmacy, prescriber, practitioner, or 1273 dispenser, the pharmacy, prescriber, practitioner, or dispenser 1274 shall register with the department by submitting a registering 1275 document provided by the department. The document and validation 1276 of that document shall be determined by the department. Before a 1277 pharmacy, prescriber, practitioner, or dispenser is granted 1278 access to information in the database from the prescription drug 1279 monitoring program, the department shall approve the submitted 1280 document. Upon approval, the department shall grant the 1281 registrant access to the appropriate information in the 1282 prescription drug monitoring program’s databasein a manner1283established by the department as needed for the purpose of1284reviewing the patient’s controlled substance prescription1285history. 1286 2. Other access to the program’s database shall be limited 1287 to the program’s manager and to the designated program and 1288 support staff, who may act only at the direction of the program 1289 manager or, in the absence of the program manager, as 1290 authorized. Access by the program manager or such designated 1291 staff is for prescription drug program management only or for 1292 management of the program’s database and its system in support 1293 of the requirements of this section and in furtherance of the 1294 prescription drug monitoring program. Confidential and exempt 1295 information in the database shall be released only as provided 1296 in paragraph (c) and s. 893.0551. The program manager, 1297 designated program and support staff who act at the direction of 1298 or in the absence of the program manager, and any individual who 1299 has similar access regarding the management of the database from 1300 the prescription drug monitoring program shall submit 1301 fingerprints to the department for background screening. The 1302 department shall follow the procedure established by the 1303 Department of Law Enforcement to request a statewide criminal 1304 history record check and to request that the Department of Law 1305 Enforcement forward the fingerprints to the Federal Bureau of 1306 Investigation for a national criminal history record check. 1307 (c) The following entities mayshallnot havebe allowed1308 direct access to information in the prescription drug monitoring 1309 program database but may request from the program manager and, 1310 when authorized by the program manager, the program manager’s 1311 program and support staff, information that is confidential and 1312 exempt under s. 893.0551. Prior to release, the request shall be 1313 verified as authentic and authorized with the requesting 1314 organization by the program manager, the program manager’s 1315 program and support staff, or as determined in rules by the 1316 department as being authentic and as having been authorized by 1317 the requesting entity: 1318 1. The department or its relevant health care regulatory 1319 boards responsible for the licensure, regulation, or discipline 1320 of practitioners, pharmacists, or other persons who are 1321 authorized to prescribe, administer, or dispense controlled 1322 substances and who are involved in a specific controlled 1323 substance investigation involving a designated person for one or 1324 more prescribed controlled substances. 1325 2. The Attorney General for Medicaid fraud cases or 1326 Medicaid investigations involving prescribed controlled 1327 substances. 1328 3. A law enforcement agency during active investigations 1329 regarding potential criminal activity, fraud, or theft regarding 1330 prescribed controlled substances. 1331 4. A patient or the legal guardian or designated health 1332 care surrogate of an incapacitated patient as described in s. 1333 893.0551 who, for the purpose of verifying the accuracy of the 1334 database information, submits a written and notarized request 1335 that includes the patient’s full name, address, and date of 1336 birth, and includes the same information if the legal guardian 1337 or health care surrogate submits the request. The patient’s 1338 phone number, current address, and a copy of a government-issued 1339 photo identification must be provided in person to the program 1340 manager along with the notarized request. The request shall be 1341 validated by the department to verify the identity of the 1342 patient and the legal guardian or health care surrogate, if the 1343 patient’s legal guardian or health care surrogate is the 1344 requestor. Such verification is also required for any request to 1345 change a patient’s prescription history or other information 1346 related to his or her information in the electronic database. 1347 5. The Agency for Health Care Administration for Medicaid 1348 fraud cases or Medicaid investigations involving prescribed 1349 controlled substances. 1350 1351 Information in the database for the electronic prescription drug 1352 monitoring system is not discoverable or admissible in any civil 1353 or administrative action, except in an investigation and 1354 disciplinary proceeding by the department or the appropriate 1355 regulatory board. 1356 (d) The following entities mayshallnot havebe allowed1357 direct access to information in the prescription drug monitoring 1358 program database but may request from the program manager and, 1359 when authorized by the program manager, the program manager’s 1360 program and support staff, information that contains no 1361 identifying information of any patient, physician, health care 1362 practitioner, prescriber, or dispenser and that is not 1363 confidential and exempt: 1364 1. Department staff for the purpose of calculating 1365 performance measures pursuant to subsection (8). 1366 2. The Program Implementation and Oversight Task Force for 1367 its reporting to the Governor, the President of the Senate, and 1368 the Speaker of the House of Representatives regarding the 1369 prescription drug monitoring program. This subparagraph expires 1370 July 1, 2012. 1371 (e) All transmissions of data required by this section must 1372 comply with relevant state and federal privacy and security laws 1373 and regulations. However, any authorized agency or person under 1374 s. 893.0551 receiving such information as allowed by s. 893.0551 1375 may maintain the information received for up to 24 months before 1376 purging it from his or her records or maintain it for longer 1377 than 24 months if the information is pertinent to ongoing health 1378 care or an active law enforcement investigation or prosecution. 1379 (f) The program manager, upon determining a pattern 1380 consistent with the rules established under paragraph (2)(d) and 1381 having cause to believe a violation of s. 893.13(7)(a)8., 1382 (8)(a), or (8)(b) has occurred, may provide relevant information 1383 to the applicable law enforcement agency. 1384 (8) To assist in fulfilling program responsibilities, 1385 performance measures shall be reported annually to the Governor, 1386 the President of the Senate, and the Speaker of the House of 1387 Representatives by the department each December 1, beginning in 1388 2011. Data that does not contain patient, physician, health care 1389 practitioner, prescriber, or dispenser identifying information 1390 may be requested during the year by department employees so that 1391 the department may undertake public health care and safety 1392 initiatives that take advantage of observed trends. Performance 1393 measures may include, but are not limited to, efforts to achieve 1394 the following outcomes: 1395 (a) Reduction of the rate of inappropriate use of 1396 prescription drugs through department education and safety 1397 efforts. 1398 (b) Reduction of the quantity of pharmaceutical controlled 1399 substances obtained by individuals attempting to engage in fraud 1400 and deceit. 1401 (c) Increased coordination among partners participating in 1402 the prescription drug monitoring program. 1403 (d) Involvement of stakeholders in achieving improved 1404 patient health care and safety and reduction of prescription 1405 drug abuse and prescription drug diversion. 1406 (9) Any person who willfully and knowingly fails to report 1407 the dispensing of a controlled substance as required by this 1408 section commits a misdemeanor of the first degree, punishable as 1409 provided in s. 775.082 or s. 775.083. 1410 (10)All costs incurred by the department in administering1411the prescription drug monitoring program shall be funded through1412federal grants or private funding applied for or received by the1413state. The department may not commit funds for the monitoring1414program without ensuring funding is available. The prescription1415drug monitoring program and the implementation thereof are1416contingent upon receipt of the nonstate funding.The department 1417 and state government shall cooperate with the direct-support 1418 organization established pursuant to subsection (11) in seeking 1419 federal grant funds, other nonstate grant funds, gifts, 1420 donations, or other private moneys for the department so long as 1421 the costs of doing so are not considered material. Nonmaterial 1422 costs for this purpose include, but are not limited to, the 1423 costs of mailing and personnel assigned to research or apply for 1424 a grant. Notwithstanding the exemptions to competitive 1425 solicitation requirements under s. 287.057(3)(f), the department 1426 shall comply with the competitive-solicitation requirements 1427 under s. 287.057 for the procurement of any goods or services 1428 required by this section. 1429 (11) The Office of Drug Control, in coordination with the 1430 department, may establish a direct-support organization that has 1431 a board consisting of at least five members to provide 1432 assistance, funding, and promotional support for the activities 1433 authorized for the prescription drug monitoring program. 1434 (a) As used in this subsection, the term “direct-support 1435 organization” means an organization that is: 1436 1. A Florida corporation not for profit incorporated under 1437 chapter 617, exempted from filing fees, and approved by the 1438 Department of State. 1439 2. Organized and operated to conduct programs and 1440 activities; raise funds; request and receive grants, gifts, and 1441 bequests of money; acquire, receive, hold, and invest, in its 1442 own name, securities, funds, objects of value, or other 1443 property, either real or personal; and make expenditures or 1444 provide funding to or for the direct or indirect benefit of the 1445 department in the furtherance of the prescription drug 1446 monitoring program. 1447 (b) The direct-support organization is not considered a 1448 lobbying firm within the meaning of s. 11.045. 1449 (c) The director of the Office of Drug Control shall 1450 appoint a board of directors for the direct-support 1451 organization. The director may designate employees of the Office 1452 of Drug Control, state employees other than state employees from 1453 the department, and any other nonstate employees as appropriate, 1454 to serve on the board. Members of the board shall serve at the 1455 pleasure of the director of the Office of Drug Control. The 1456 director shall provide guidance to members of the board to 1457 ensure that moneys received by the direct-support organization 1458 are not received from inappropriate sources. Inappropriate 1459 sources include, but are not limited to, donors, grantors, 1460 persons, or organizations that may monetarily or substantively 1461 benefit from the purchase of goods or services by the department 1462 in furtherance of the prescription drug monitoring program. 1463 (d) The direct-support organization shall operate under 1464 written contract with the Office of Drug Control. The contract 1465 must, at a minimum, provide for: 1466 1. Approval of the articles of incorporation and bylaws of 1467 the direct-support organization by the Office of Drug Control. 1468 2. Submission of an annual budget for the approval of the 1469 Office of Drug Control. 1470 3. Certification by the Office of Drug Control in 1471 consultation with the department that the direct-support 1472 organization is complying with the terms of the contract in a 1473 manner consistent with and in furtherance of the goals and 1474 purposes of the prescription drug monitoring program and in the 1475 best interests of the state. Such certification must be made 1476 annually and reported in the official minutes of a meeting of 1477 the direct-support organization. 1478 4. The reversion, without penalty, to the Office of Drug 1479 Control, or to the state if the Office of Drug Control ceases to 1480 exist, of all moneys and property held in trust by the direct 1481 support organization for the benefit of the prescription drug 1482 monitoring program if the direct-support organization ceases to 1483 exist or if the contract is terminated. 1484 5. The fiscal year of the direct-support organization, 1485 which must begin July 1 of each year and end June 30 of the 1486 following year. 1487 6. The disclosure of the material provisions of the 1488 contract to donors of gifts, contributions, or bequests, 1489 including such disclosure on all promotional and fundraising 1490 publications, and an explanation to such donors of the 1491 distinction between the Office of Drug Control and the direct 1492 support organization. 1493 7. The direct-support organization’s collecting, expending, 1494 and providing of funds to the department for the development, 1495 implementation, and operation of the prescription drug 1496 monitoring program as described in this section and s. 2, 1497 chapter 2009-198, Laws of Florida, as long as the task force is 1498 authorized. The direct-support organization may collect and 1499 expend funds to be used for the functions of the direct-support 1500 organization’s board of directors, as necessary and approved by 1501 the director of the Office of Drug Control. In addition, the 1502 direct-support organization may collect and provide funding to 1503 the department in furtherance of the prescription drug 1504 monitoring program by: 1505 a. Establishing and administering the prescription drug 1506 monitoring program’s electronic database, including hardware and 1507 software. 1508 b. Conducting studies on the efficiency and effectiveness 1509 of the program to include feasibility studies as described in 1510 subsection (13). 1511 c. Providing funds for future enhancements of the program 1512 within the intent of this section. 1513 d. Providing user training of the prescription drug 1514 monitoring program, including distribution of materials to 1515 promote public awareness and education and conducting workshops 1516 or other meetings, for health care practitioners, pharmacists, 1517 and others as appropriate. 1518 e. Providing funds for travel expenses. 1519 f. Providing funds for administrative costs, including 1520 personnel, audits, facilities, and equipment. 1521 g. Fulfilling all other requirements necessary to implement 1522 and operate the program as outlined in this section. 1523 (e) The activities of the direct-support organization must 1524 be consistent with the goals and mission of the Office of Drug 1525 Control, as determined by the office in consultation with the 1526 department, and in the best interests of the state. The direct 1527 support organization must obtain a written approval from the 1528 director of the Office of Drug Control for any activities in 1529 support of the prescription drug monitoring program before 1530 undertaking those activities. 1531 (f) The Office of Drug Control, in consultation with the 1532 department, may permit, without charge, appropriate use of 1533 administrative services, property, and facilities of the Office 1534 of Drug Control and the department by the direct-support 1535 organization, subject to this section. The use must be directly 1536 in keeping with the approved purposes of the direct-support 1537 organization and may not be made at times or places that would 1538 unreasonably interfere with opportunities for the public to use 1539 such facilities for established purposes. Any moneys received 1540 from rentals of facilities and properties managed by the Office 1541 of Drug Control and the department may be held by the Office of 1542 Drug Control or in a separate depository account in the name of 1543 the direct-support organization and subject to the provisions of 1544 the letter of agreement with the Office of Drug Control. The 1545 letter of agreement must provide that any funds held in the 1546 separate depository account in the name of the direct-support 1547 organization must revert to the Office of Drug Control if the 1548 direct-support organization is no longer approved by the Office 1549 of Drug Control to operate in the best interests of the state. 1550 (g) The Office of Drug Control, in consultation with the 1551 department, may adopt rules under s. 120.54 to govern the use of 1552 administrative services, property, or facilities of the 1553 department or office by the direct-support organization. 1554 (h) The Office of Drug Control may not permit the use of 1555 any administrative services, property, or facilities of the 1556 state by a direct-support organization if that organization does 1557 not provide equal membership and employment opportunities to all 1558 persons regardless of race, color, religion, gender, age, or 1559 national origin. 1560 (i) The direct-support organization shall provide for an 1561 independent annual financial audit in accordance with s. 1562 215.981. Copies of the audit shall be provided to the Office of 1563 Drug Control and the Office of Policy and Budget in the 1564 Executive Office of the Governor. 1565 (j) The direct-support organization may not exercise any 1566 power under s. 617.0302(12) or (16). 1567 (12) A prescriber or dispenser may have access to the 1568 information under this section which relates to a patient of 1569 that prescriber or dispenser as needed for the purpose of 1570 reviewing the patient’s controlled drug prescription history. A 1571 prescriber or dispenser acting in good faith is immune from any 1572 civil, criminal, or administrative liability that might 1573 otherwise be incurred or imposed for receiving or using 1574 information from the prescription drug monitoring program. This 1575 subsection does not create a private cause of action, and a 1576 person may not recover damages against a prescriber or dispenser 1577 authorized to access information under this subsection for 1578 accessing or failing to access such information. 1579 (13) To the extent that funding is provided for such 1580 purpose through federal or private grants or gifts and other 1581 types of available moneys, the department, in collaboration with 1582 the Office of Drug Control, shall study the feasibility of 1583 enhancing the prescription drug monitoring program for the 1584 purposes of public health initiatives and statistical reporting 1585 that respects the privacy of the patient, the prescriber, and 1586 the dispenser. Such a study shall be conducted in order to 1587 further improve the quality of health care services and safety 1588 by improving the prescribing and dispensing practices for 1589 prescription drugs, taking advantage of advances in technology, 1590 reducing duplicative prescriptions and the overprescribing of 1591 prescription drugs, and reducing drug abuse. The requirements of 1592 the National All Schedules Prescription Electronic Reporting 1593 (NASPER) Act are authorized in order to apply for federal NASPER 1594 funding. In addition, the direct-support organization shall 1595 provide funding for the department, in collaboration with the 1596 Office of Drug Control, to conduct training for health care 1597 practitioners and other appropriate persons in using the 1598 monitoring program to support the program enhancements. 1599 (14) A pharmacist, pharmacy, or dispensing health care 1600 practitioner or his or her agent, before releasing a controlled 1601 substance to any person not known to such dispenser, shall 1602 require the person purchasing, receiving, or otherwise acquiring 1603 the controlled substance to present valid photographic 1604 identification or other verification of his or her identity to 1605 the dispenser. If the person does not have proper 1606 identification, the dispenser may verify the validity of the 1607 prescription and the identity of the patient with the prescriber 1608 or his or her authorized agent. Verification of health plan 1609 eligibility through a real-time inquiry or adjudication system 1610 will be considered to be proper identification. This subsection 1611 does not apply in an institutional setting or to a long-term 1612 care facility, including, but not limited to, an assisted living 1613 facility or a hospital to which patients are admitted. As used 1614 in this subsection, the term “proper identification” means an 1615 identification that is issued by a state or the Federal 1616 Government containing the person’s photograph, printed name, and 1617 signature or a document considered acceptable under 8 C.F.R. s. 1618 274a.2(b)(1)(v)(A) and (B). 1619 (15) The Agency for Health Care Administration shall 1620 continue the promotion of electronic prescribing by health care 1621 practitioners, health care facilities, and pharmacies under s. 1622 408.0611. 1623 (16) By October 1, 2010, the department shall adopt rules 1624 pursuant to ss. 120.536(1) and 120.54 to administer the 1625 provisions of this section, which shall include as necessary the 1626 reporting, accessing, evaluation, management, development, 1627 implementation, operation, and storage of information within the 1628 monitoring program’s system. 1629 (17) After the prescription drug monitoring program has 1630 been operational for 12 months, the State Surgeon General shall 1631 enter into reciprocal agreements for the sharing of prescription 1632 drug monitoring information with any other state that has a 1633 compatible prescription drug monitoring program. If the State 1634 Surgeon General evaluates the prescription drug monitoring 1635 program of another state as authorized in this subsection, 1636 priority shall be given to a state that is contiguous with the 1637 borders of this state. 1638 (a) In determining compatibility, the State Surgeon General 1639 shall consider: 1640 1. The essential purposes of the program and the success of 1641 the program in fulfilling those purposes. 1642 2. The safeguards for privacy of patient records and the 1643 success of the program in protecting patient privacy. 1644 3. The persons authorized to view the data collected by the 1645 program. Comparable organizations and professions for 1646 practitioners in other states, law enforcement agencies, the 1647 Attorney General’s Medicaid Fraud Unit, medical regulatory 1648 boards, and, as needed, management staff who have similar duties 1649 as management staff who work with the prescription drug 1650 monitoring program as authorized in s. 893.0551 are authorized 1651 access upon approval by the State Surgeon General. 1652 4. The schedules of the controlled substances that are 1653 monitored. 1654 5. The data required to be submitted for each prescription. 1655 6. Any implementing criteria deemed essential for a 1656 thorough comparison. 1657 (b) The State Surgeon General shall annually review any 1658 agreement to determine its continued compatibility with the 1659 prescription drug monitoring program in this state. 1660 (c) Any agreement between the State Surgeon General and 1661 another state shall prohibit the sharing of information 1662 concerning a resident of this state or a practitioner, 1663 pharmacist, or other prescriber for any purpose that is not 1664 otherwise authorized by this section or s. 893.0551. 1665 Section 22. Present subsections (4), (5), (6), and (7) of 1666 section 893.0551, Florida Statutes, are redesignated as 1667 subsections (5), (6), (7), and (8), respectively, and a new 1668 subsection (4) is added to that section, to read: 1669 893.0551 Public records exemption for the prescription drug 1670 monitoring program.— 1671 (4) The department may disclose confidential and exempt 1672 information contained in records held by the department under s. 1673 893.055 if the State Surgeon General has entered into a 1674 reciprocal agreement for the sharing of prescription drug 1675 monitoring information with any other state that has a 1676 compatible prescription drug monitoring program. 1677 (a) The reciprocal agreement may allow the following 1678 persons from another state to receive information from the 1679 prescription drug monitoring program if approved by the State 1680 Surgeon General: 1681 1. A designated representative of a state professional 1682 licensing, certification, or regulatory agency charged with 1683 oversight of those persons authorized to prescribe or dispense 1684 controlled substances for the purpose of a bona fide, specific 1685 investigation of a prescription of a controlled substance which 1686 involves a designated person. As required in s. 893.055, this 1687 authorization does not preclude the requirement for the program 1688 manager to review the request for information and validate it. 1689 2. A health care practitioner or pharmacist licensed in the 1690 state from which the request originates. Such health care 1691 practitioner or pharmacist shall certify that the requested 1692 information is for the purpose of providing medical or 1693 pharmaceutical treatment to a bona fide, current patient. The 1694 health care practitioner or pharmacist shall follow all the 1695 procedures required in s. 893.055 and rules established by the 1696 department for a health care practitioner or pharmacist to 1697 request information from the database. 1698 3. A law enforcement officer from another state: 1699 a. Who is a member of a sheriff’s department or a police 1700 department; 1701 b. Who is authorized by law to conduct criminal 1702 investigations and make arrests; 1703 c. Whose duty it is to enforce the laws of his or her state 1704 relating to controlled substances; and 1705 d. Who is engaged in a bona fide specific, active 1706 investigation involving a designated person regarding 1707 prescriptions for controlled substances. 1708 1709 As required in s. 893.055, this authorization does not preclude 1710 the requirement for the program manager to review the request 1711 for information and validate it. This authorization also does 1712 not preclude the ability to provide a report to a law 1713 enforcement agency in another state under s. 893.055(7) or this 1714 subsection. 1715 (b) Any agreement between the State Surgeon General and 1716 another state shall prohibit the sharing of information 1717 concerning a resident of this state, a patient whose information 1718 is in the program’s database, or a practitioner, pharmacy, 1719 pharmacist, health care practitioner, or other prescriber for 1720 any purpose that is not otherwise authorized by this section or 1721 s. 893.055, and the information must be provided according to 1722 the State Surgeon General’s determination of compatibility as 1723 described in s. 893.055(17). 1724 Section 23. Subsections (1), (4), and (5) of section 1725 893.07, Florida Statutes, are amended, and subsection (6) is 1726 added to that section, to read: 1727 893.07 Records.— 1728 (1) Notwithstanding any other provision of law and in 1729 consonance with the authority of State v. Carter, 23 So. 3d 798 1730 (Fla. 1st DCA 2009) and State v. Tamulonis, 39 So. 3d 524 (Fla. 1731 2nd DCA 2010), every person who engages in the manufacture, 1732 compounding, mixing, cultivating, growing, or by any other 1733 process producing or preparing, or in the dispensing, 1734 importation, or, as a wholesaler, distribution, of controlled 1735 substances shall: 1736 (a) On January 1, 1974, or as soon thereafter as any person 1737 first engages in such activity, and every second year 1738 thereafter, make a complete and accurate record of all stocks of 1739 controlled substances on hand. The inventory may be prepared on 1740 the regular physical inventory date which is nearest to, and 1741 does not vary by more than 6 months from, the biennial date that 1742 would otherwise apply. As additional substances are designated 1743 for control under this chapter, they shall be inventoried as 1744 provided for in this subsection. 1745 (b) On and after January 1, 1974, maintain, on a current 1746 basis, a complete and accurate record of each substance 1747 manufactured, received, sold, delivered, or otherwise disposed 1748 of by him or her, except that this subsection shall not require 1749 the maintenance of a perpetual inventory. 1750 1751 Compliance with the provisions of federal law pertaining to the 1752 keeping of records of controlled substances shall be deemed a 1753 compliance with the requirements of this subsection. 1754 (4) Every inventory or record required by this chapter, 1755 including prescription records, shall be maintained: 1756 (a) Separately from all other records of the registrant, or 1757 (b) Alternatively, in the case of Schedule III, IV, or V 1758 controlled substances, in such form that information required by 1759 this chapter is readily retrievable from the ordinary business 1760 records of the registrant. 1761 1762 In either case, such records described in this subsection shall 1763 be kept and made available for a period of at least 2 years for 1764 inspection and copying by law enforcement officers whose duty it 1765 is to enforce the laws of this state relating to controlled 1766 substances. This subsection does not require a law enforcement 1767 officer to obtain a subpoena, court order, or search warrant in 1768 order to obtain access to or copies of such records. 1769 (5) Each person shall maintain a record that containswhich1770shall containa detailed list of controlled substances lost, 1771 destroyed, or stolen, if any; the kind and quantity of such 1772 controlled substances; and the date of the discovering of such 1773 loss, destruction, or theft. If a person discovers the theft or 1774 loss of a controlled substance, such person shall report the 1775 theft or loss to a local county sheriff’s office within 48 hours 1776 after the discovery of such theft or loss. A person who fails to 1777 report the theft or loss of a controlled substance under this 1778 subsection commits a misdemeanor of the second degree, 1779 punishable as provided in s. 775.082 or s. 775.083. However, a 1780 person who fails to report the theft or loss of a Schedule II 1781 controlled substance commits a misdemeanor of the first degree, 1782 punishable as provided in s. 775.082 or s. 775.083. 1783 (6) The Legislature finds that the opinions rendered in 1784 State v. Carter, 23 So. 3d 798 (Fla. 1st DCA 2009), and State v. 1785 Tamulonis, 39 So. 3d 524 (Fla. 2nd DCA 2010), correctly construe 1786 this Legislature’s intent that the inspection powers previously 1787 conferred upon law enforcement officers which allow such 1788 officers to access and review pharmacy records concerning 1789 controlled substances are to be exercised properly by such law 1790 enforcement officers without the requirement of a subpoena or 1791 search warrant being sought or issued to examine and copy such 1792 records, and without the requirement that those persons to whom 1793 particular pharmacy records refer be given notice of the 1794 records’ examination and copying under this section. 1795 Section 24. Subsections (7) and (8) of section 893.13, 1796 Florida Statutes, are amended to read: 1797 893.13 Prohibited acts; penalties.— 1798 (7)(a) AIt is unlawful for anyperson may not: 1799 1.ToDistribute or dispense a controlled substance in 1800 violation of this chapter. 1801 2.ToRefuse or fail to make, keep, or furnish any record, 1802 notification, order form, statement, invoice, or information 1803 required under this chapter. 1804 3.ToRefuseanentry into any premises for any inspection 1805 ortorefuse to allow any inspection authorized by this chapter. 1806 4.ToDistribute a controlled substance named or described 1807 in s. 893.03(1) or (2) except pursuant to an order form as 1808 required by s. 893.06. 1809 5.ToKeep or maintain any store, shop, warehouse, 1810 dwelling, building, vehicle, boat, aircraft, or other structure 1811 or place which is resorted to by persons using controlled 1812 substances in violation of this chapter for the purpose of using 1813 these substances, or which is used for keeping or selling them 1814 in violation of this chapter. 1815 6.ToUse to his or her own personal advantage, orto1816 reveal, any information obtained in enforcement of this chapter 1817 except in a prosecution or administrative hearing for a 1818 violation of this chapter. 1819 7.ToPossess a prescription form which has not been 1820 completed and signed by the practitioner whose name appears 1821 printed thereon, unless the person is that practitioner, is an 1822 agent or employee of that practitioner, is a pharmacist, or is a 1823 supplier of prescription forms who is authorized by that 1824 practitioner to possess those forms. 1825 8.ToWithhold information from a practitioner from whom 1826 the person seeks to obtain a controlled substance or a 1827 prescription for a controlled substance that the person making 1828 the request has received a controlled substance or a 1829 prescription for a controlled substance of like therapeutic use 1830 from another practitioner within the previous 30 days. 1831 9.ToAcquire or obtain, or attempt to acquire or obtain, 1832 possession of a controlled substance by misrepresentation, 1833 fraud, forgery, deception, or subterfuge. 1834 10.ToAffix any false or forged label to a package or 1835 receptacle containing a controlled substance. 1836 11.ToFurnish false or fraudulent material information in, 1837 or omit any material information from, any report or other 1838 document required to be kept or filed under this chapter or any 1839 record required to be kept by this chapter. 1840 12.ToStore anhydrous ammonia in a container that is not 1841 approved by the United States Department of Transportation to 1842 hold anhydrous ammonia or is not constructed in accordance with 1843 sound engineering, agricultural, or commercial practices. 1844 13. With the intent to obtain a controlled substance or 1845 combination of controlled substances that are not medically 1846 necessary for the person or an amount of a controlled substance 1847 or substances that are not medically necessary for the person, 1848 obtain or attempt to obtain from a practitioner a controlled 1849 substance or a prescription for a controlled substance by 1850 misrepresentation, fraud, forgery, deception, subterfuge, or 1851 concealment of a material fact. For purposes of this 1852 subparagraph, a material fact includes whether the person has an 1853 existing prescription for a controlled substance issued for the 1854 same period of time by another practitioner or as described in 1855 subparagraph 8. 1856 (b) A health care practitioner, with the intent to provide 1857 a controlled substance or combination of controlled substances 1858 that are not medically necessary to his or her patient or an 1859 amount of controlled substances that are not medically necessary 1860 for his or her patient, may not provide a controlled substance 1861 or a prescription for a controlled substance by 1862 misrepresentation, fraud, forgery, deception, subterfuge, or 1863 concealment of a material fact. For purposes of this paragraph, 1864 a material fact includes whether the patient has an existing 1865 prescription for a controlled substance issued for the same 1866 period of time by another practitioner or as described in 1867 subparagraph (a)8. 1868 (c) Any person who adulterates a controlled substance for 1869 directed off-label use without authorization by a prescribing 1870 physician violates the provisions of subparagraph (a)1. and 1871 causes the issuance of the entire prescription for the 1872 controlled substance to become invalid. A law enforcement 1873 officer in the performance of his or her official duties may 1874 seize the adulterated or off-label prescribed controlled 1875 substance as evidence. The controlled substance may be returned 1876 to the owner only with a notarized affidavit from the original 1877 prescribing practitioner who has knowledge and gave 1878 authorization and explicit directions for the adulteration or 1879 off-label use of the controlled substance. 1880 (d)(b)Any person who violates the provisions of 1881 subparagraphs (a)1.-7. commits a misdemeanor of the first 1882 degree, punishable as provided in s. 775.082 or s. 775.083; 1883 except that, upon a second or subsequent violation, the person 1884 commits a felony of the third degree, punishable as provided in 1885 s. 775.082, s. 775.083, or s. 775.084. 1886 (e)(c)Any person who violates the provisions of 1887 subparagraphs (a)8.-12. commits a felony of the third degree, 1888 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 1889 (f) A person or health care practitioner who violates the 1890 provisions of paragraph (b) or subparagraph (a)13. commits a 1891 felony of the third degree, punishable as provided in s. 1892 775.082, s. 775.083, or s. 775.084, if any controlled substance 1893 that is the subject of the offense is listed in Schedule II, 1894 Schedule III, or Schedule IV. 1895 (8)(a) Notwithstanding subsection (9), a prescribing 1896 practitioner may not: 1897 1. Knowingly assist a patient, other person, or the owner 1898 of an animal in obtaining a controlled substance through 1899 deceptive, untrue, or fraudulent representations in or related 1900 to the practice of the prescribing practitioner’s professional 1901 practice; 1902 2. Employ a trick or scheme in the practice of the 1903 prescribing practitioner’s professional practice to assist a 1904 patient, other person, or the owner of an animal in obtaining a 1905 controlled substance; 1906 3. Knowingly write a prescription for a controlled 1907 substance for a fictitious person;or1908 4. Write a prescription for a controlled substance for a 1909 patient, other person, or an animal if the sole purpose of 1910 writing such prescription is to provide a monetary benefit to, 1911 or obtain a monetary benefit for, the prescribing practitioner; 1912 or.1913 5. Write a prescription for a controlled substance for a 1914 patient, other person, or an animal and authorize or direct the 1915 adulteration of the dispensed form of the controlled substance 1916 for the purpose of ingestion by means of inhalation, injection, 1917 or any other means not medically necessary for the treatment of 1918 the patient. 1919 (b) If the prescribing practitioner wrote a prescription or 1920 multiple prescriptions for a controlled substance for the 1921 patient, other person, or animal for which there was no medical 1922 necessity, or which was in excess of what was medically 1923 necessary to treat the patient, other person, or animal, that 1924 fact does not give rise to any presumption that the prescribing 1925 practitioner violated subparagraph (a)1., but may be considered 1926 with other competent evidence in determining whether the 1927 prescribing practitioner knowingly assisted a patient, other 1928 person, or the owner of an animal to obtain a controlled 1929 substance in violation of subparagraph (a)1. 1930 (c) A person who violates paragraph (a) commits a felony of 1931 the third degree, punishable as provided in s. 775.082, s. 1932 775.083, or s. 775.084. 1933 (d) Notwithstanding paragraph (c), if a prescribing 1934 practitioner has violated paragraph (a) and received $1,000 or 1935 more in payment for writing one or more prescriptions or, in the 1936 case of a prescription written for a controlled substance 1937 described in s. 893.135, has written one or more prescriptions 1938 for a quantity of a controlled substance which, individually or 1939 in the aggregate, meets the threshold for the offense of 1940 trafficking in a controlled substance under s. 893.15, the 1941 violation is reclassified as a felony of the second degree and 1942 ranked in level 4 of the Criminal Punishment Code. 1943 Section 25. Present subsections (3) through (10) of section 1944 893.138, Florida Statutes, are redesignated as subsections (4) 1945 through (11), respectively, and a new subsection (3) is added to 1946 that section, to read: 1947 893.138 Local administrative action to abate drug-related, 1948 prostitution-related, or stolen-property-related public 1949 nuisances and criminal gang activity.— 1950 (3) Any pain-management clinic, as described in s. 458.3265 1951 or s. 459.0137, which has been used on more than two occasions 1952 within a 6-month period as the site of a violation of: 1953 (a) Section 784.011, s. 784.021, s. 784.03, or s. 784.045, 1954 relating to assault and battery; 1955 (b) Section 810.02, relating to burglary; 1956 (c) Section 812.014, relating to dealing in theft; 1957 (d) Section 812.131, relating to robbery by sudden 1958 snatching; or 1959 (e) Section 893.13, relating to the unlawful distribution 1960 of controlled substances, 1961 1962 may be declared to be a public nuisance, and such nuisance may 1963 be abated pursuant to the procedures provided in this section. 1964 Section 26. (1) DEFINITIONS.—As used in this section, the 1965 term: 1966 (a) “Interchange or substitution of an opioid analgesic 1967 drug” means the substitution of any opioid analgesic drug, brand 1968 or generic, for the opioid analgesic drug incorporating a 1969 tamper-resistance technology originally prescribed, irrespective 1970 of whether the substituted drug is rated as pharmaceutically and 1971 therapeutically equivalent by the United States Food and Drug 1972 Administration or the Board of Pharmacy or whether the opioid 1973 analgesic drug with tamper-resistance technology bears a 1974 labeling claim with respect to reduction of tampering, abuse, or 1975 abuse potential. 1976 (b) “Opioid analgesic drug” means a drug in the opioid 1977 analgesic drug class prescribed to treat moderate to severe pain 1978 or other conditions, whether in immediate release or extended 1979 release form and whether or not combined with other drug 1980 substances to form a single tablet or other dosage form. 1981 (c) “Opioid analgesic drug incorporating a tamper 1982 resistance technology” means an opioid analgesic drug listed as 1983 such by the Board of Pharmacy based on a submission of evidence 1984 by the drug manufacturer or distributor that the drug: 1985 1. Incorporates a tamper-resistance technology; and 1986 2. Has been approved by the United States Food and Drug 1987 Administration pursuant to an application that includes at least 1988 one study on human tampering or abuse potential or a laboratory 1989 study comparing the tamper- or abuse-resistance properties of 1990 the drug to one or more opioid analgesic drugs that: 1991 a. Have been approved by the United States Food and Drug 1992 Administration; and 1993 b. Serve as a positive control. 1994 (d) “Pharmacist” means any person licensed under chapter 1995 465, Florida Statutes, to practice the profession of pharmacy, 1996 including, but not limited to, a community pharmacist and a 1997 pharmacist in a hospital-based pharmacy, when filling 1998 prescriptions for inpatient or outpatient care. 1999 (2) LIST OF OPIOID ANALGESIC DRUGS INCORPORATING A TAMPER 2000 RESISTANCE TECHNOLOGY.—The Board of Pharmacy shall create a list 2001 of opioid analgesic drugs for which information has been 2002 submitted consistent with paragraph (1)(c). Inclusion of a drug 2003 on such list does not require that the drug bear a labeling 2004 claim with respect to reduction of tampering, abuse, or abuse 2005 potential at the time of listing. Such list must also include a 2006 determination by the Board of Pharmacy as to which listed opioid 2007 analgesic drugs incorporating tamper-resistance technologies 2008 provide substantially similar tamper-resistance properties, 2009 based solely on studies submitted by the drug manufacturer 2010 consistent with paragraph (1)(c). 2011 (3) PROHIBITION.—Notwithstanding s. 465.025, Florida 2012 Statutes, a pharmacist may not interchange or substitute an 2013 opioid analgesic drug, brand or generic, for an opioid analgesic 2014 drug incorporating a tamper-resistance technology which is 2015 listed pursuant to subsection (2) without: 2016 (a) Verifying that the opioid analgesic drug has been 2017 listed by the Board of Pharmacy under subsection (2) as 2018 providing tamper-resistance properties substantially similar to 2019 the prescribed opioid analgesic drug incorporating a tamper 2020 resistance technology; or 2021 (b) Obtaining written, signed consent from the prescribing 2022 physician for such interchange or substitution. 2023 Section 27. This act shall take effect October 1, 2011.