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 CS for SB 818 By the Committees on Criminal Justice; and Health Regulation; and Senator Fasano 591-02844-11 2011818c2 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 licensed pharmacist or 99 other person employed by or at a pharmacy is not 100 subject to disciplinary action for reporting; amending 101 s. 465.0276, F.S.; requiring a practitioner to 102 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.; requiring the Department of Health to 174 disclose confidential and exempt information 175 pertaining to the prescription drug monitoring program 176 to the Attorney General and designee when working on 177 Medicaid fraud cases and Medicaid investigations 178 involving prescribed controlled substances or when the 179 Attorney General has initiated a review of specific 180 identifiers that warrant a Medicaid investigation 181 regarding prescribed controlled substances; 182 prohibiting the Attorney General’s Medicaid 183 investigators from direct access to the prescription 184 drug monitoring program’s database; authorizing the 185 Department of Health to disclose certain confidential 186 and exempt information in the prescription drug 187 monitoring program’s database under certain 188 circumstances involving reciprocal agreements with 189 other states; prohibiting the sharing of information 190 from the prescription drug monitoring program’s 191 database which is not for the purpose that is 192 statutorily authorized or according to the State 193 Surgeon General’s determination of compatibility; 194 amending s. 893.07, F.S.; requiring that a person 195 report to the local sheriff’s office the theft or loss 196 of a controlled substance within a specified time; 197 providing penalties; providing legislative intent; 198 amending s. 893.13, F.S.; prohibiting a person from 199 obtaining or attempting to obtain from a practitioner 200 a controlled substance or a prescription for a 201 controlled substance by misrepresentation, fraud, 202 forgery, deception, subterfuge, or concealment of a 203 material fact; prohibiting a health care provider from 204 providing a controlled substance or a prescription for 205 a controlled substance by misrepresentation, fraud, 206 forgery, deception, subterfuge, or concealment of a 207 material fact; prohibiting a person from adulterating 208 a controlled substance for certain use without 209 authorization by a prescribing physician; authorizing 210 a law enforcement officer to seize as evidence the 211 adulteration or off-label use of a prescribed 212 controlled substance; providing that such adulterated 213 or off-label use of the controlled substance may be 214 returned to its owner only under certain conditions; 215 providing penalties; prohibiting a prescribing 216 practitioner from writing a prescription for a 217 controlled substance and authorizing or directing the 218 adulteration of the dispensed form of the controlled 219 substance for the purpose of ingestion by means not 220 medically necessary; amending s. 893.138, F.S.; 221 providing circumstances in which a pain-management 222 clinic may be declared a public nuisance; providing 223 definitions; requiring the Board of Pharmacy to create 224 a list of opioid analgesic drugs; providing 225 requirements for the list of opioid analgesic drugs; 226 providing an effective date. 227 228 Be It Enacted by the Legislature of the State of Florida: 229 230 Section 1. Subsections (4) and (7) of section 400.9905, 231 Florida Statutes, are amended to read: 232 400.9905 Definitions.— 233 (4) “Clinic” means an entity at which health care services 234 are provided to individuals and which tenders charges for 235 reimbursement or payment for such services, including a mobile 236 clinic and a portable equipment provider. For purposes of this 237 part, the term does not include and the licensure requirements 238 of this part do not apply to: 239 (a) Entities licensed or registered by the state under 240 chapter 395; or entities licensed or registered by the state and 241 providing only health care services within the scope of services 242 authorized under their respective licenses granted under ss. 243 383.30-383.335, chapter 390, chapter 394, chapter 397, this 244 chapter except part X, chapter 429, chapter 463, chapter 465, 245 chapter 466, chapter 478, part I of chapter 483, chapter 484, or 246 chapter 651; end-stage renal disease providers authorized under 247 42 C.F.R. part 405, subpart U; or providers certified under 42 248 C.F.R. part 485, subpart B or subpart H; or any entity that 249 provides neonatal or pediatric hospital-based health care 250 services or other health care services by licensed practitioners 251 solely within a hospital licensed under chapter 395. 252 (b) Entities that own, directly or indirectly, entities 253 licensed or registered by the state pursuant to chapter 395; or 254 entities that own, directly or indirectly, entities licensed or 255 registered by the state and providing only health care services 256 within the scope of services authorized pursuant to their 257 respective licenses granted under ss. 383.30-383.335, chapter 258 390, chapter 394, chapter 397, this chapter except part X, 259 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, 260 part I of chapter 483, chapter 484, chapter 651; end-stage renal 261 disease providers authorized under 42 C.F.R. part 405, subpart 262 U; or providers certified under 42 C.F.R. part 485, subpart B or 263 subpart H; or any entity that provides neonatal or pediatric 264 hospital-based health care services by licensed practitioners 265 solely within a hospital licensed under chapter 395. 266 (c) Entities that are owned, directly or indirectly, by an 267 entity licensed or registered by the state pursuant to chapter 268 395; or entities that are owned, directly or indirectly, by an 269 entity licensed or registered by the state and providing only 270 health care services within the scope of services authorized 271 pursuant to their respective licenses granted under ss. 383.30 272 383.335, chapter 390, chapter 394, chapter 397, this chapter 273 except part X, chapter 429, chapter 463, chapter 465, chapter 274 466, chapter 478, part I of chapter 483, chapter 484, or chapter 275 651; end-stage renal disease providers authorized under 42 276 C.F.R. part 405, subpart U; or providers certified under 42 277 C.F.R. part 485, subpart B or subpart H; or any entity that 278 provides neonatal or pediatric hospital-based health care 279 services by licensed practitioners solely within a hospital 280 under chapter 395. 281 (d) Entities that are under common ownership, directly or 282 indirectly, with an entity licensed or registered by the state 283 pursuant to chapter 395; or entities that are under common 284 ownership, directly or indirectly, with an entity licensed or 285 registered by the state and providing only health care services 286 within the scope of services authorized pursuant to their 287 respective licenses granted under ss. 383.30-383.335, chapter 288 390, chapter 394, chapter 397, this chapter except part X, 289 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, 290 part I of chapter 483, chapter 484, or chapter 651; end-stage 291 renal disease providers authorized under 42 C.F.R. part 405, 292 subpart U; or providers certified under 42 C.F.R. part 485, 293 subpart B or subpart H; or any entity that provides neonatal or 294 pediatric hospital-based health care services by licensed 295 practitioners solely within a hospital licensed under chapter 296 395. 297 (e) An entity that is exempt from federal taxation under 26 298 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan 299 under 26 U.S.C. s. 409 that has a board of trustees not less 300 than two-thirds of which are Florida-licensed health care 301 practitioners and provides only physical therapy services under 302 physician orders, any community college or university clinic, 303 and any entity owned or operated by the federal or state 304 government, including agencies, subdivisions, or municipalities 305 thereof. 306 (f) A sole proprietorship, group practice, partnership, or 307 corporation that provides health care services by physicians 308 covered by s. 627.419, that is directly supervised by one or 309 more of such physicians, and that is wholly owned by one or more 310 of those physicians or by a physician and the spouse, parent, 311 child, or sibling of that physician. 312 (g) A sole proprietorship, group practice, partnership, or 313 corporation that provides health care services by licensed 314 health care practitioners under chapter 457, chapter 458, 315 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, 316 chapter 466, chapter 467, chapter 480, chapter 484, chapter 486, 317 chapter 490, chapter 491, or part I, part III, part X, part 318 XIII, or part XIV of chapter 468, or s. 464.012, which are 319 wholly owned by one or more licensed health care practitioners, 320 or the licensed health care practitioners set forth in this 321 paragraph and the spouse, parent, child, or sibling of a 322 licensed health care practitioner, so long as one of the owners 323 who is a licensed health care practitioner is supervising the 324 business activities and is legally responsible for the entity’s 325 compliance with all federal and state laws. However, a health 326 care practitioner may not supervise services beyond the scope of 327 the practitioner’s license, except that, for the purposes of 328 this part, a clinic owned by a licensee in s. 456.053(3)(b) that 329 provides only services authorized pursuant to s. 456.053(3)(b) 330 may be supervised by a licensee specified in s. 456.053(3)(b). 331 (h) Clinical facilities affiliated with an accredited 332 medical school at which training is provided for medical 333 students, residents, or fellows. 334 (i) Entities that provide only oncology or radiation 335 therapy services by physicians licensed under chapter 458 or 336 chapter 459 or entities that provide oncology or radiation 337 therapy services by physicians licensed under chapter 458 or 338 chapter 459 which are owned by a corporation whose shares are 339 publicly traded on a recognized stock exchange. 340 (j) Clinical facilities affiliated with a college of 341 chiropractic accredited by the Council on Chiropractic Education 342 at which training is provided for chiropractic students. 343 (k) Entities that provide licensed practitioners to staff 344 emergency departments or to deliver anesthesia services in 345 facilities licensed under chapter 395 and that derive at least 346 90 percent of their gross annual revenues from the provision of 347 such services. Entities claiming an exemption from licensure 348 under this paragraph must provide documentation demonstrating 349 compliance. 350 (l) Orthotic or prosthetic clinical facilities that are a 351 publicly traded corporation or that are wholly owned, directly 352 or indirectly, by a publicly traded corporation. As used in this 353 paragraph, a publicly traded corporation is a corporation that 354 issues securities traded on an exchange registered with the 355 United States Securities and Exchange Commission as a national 356 securities exchange. 357 (7) “Portable equipment provider” means an entity that 358 contracts with or employs persons to provide portable equipment 359 to multiple locations performing treatment or diagnostic testing 360 of individuals, that bills third-party payors for those361services,and that otherwise meets the definition of a clinic in 362 subsection (4). 363 Section 2. Subsection (7) of section 456.013, Florida 364 Statutes, is amended to read: 365 456.013 Department; general licensing provisions.— 366 (7)(a) The boards, or the department when there is no 367 board, shall require the completion of a 2-hour course relating 368 to prevention of medical errors as part of the licensure and 369 renewal process. The 2-hour course countsshall counttowards 370 the total number of continuing education hours required for the 371 profession. The board or department shall approve the course 372shall be approved by the board or department, as appropriate, 373 which mustand shallinclude a study of root-cause analysis, 374 error reduction and prevention, and patient safety. In addition, 375 the course approved by the Board of Medicine and the Board of 376 Osteopathic Medicine mustshallinclude information relating to 377 the five most misdiagnosed conditions during the previous 378 biennium, as determined by the board. If the course is being 379 offered by a facility licensed underpursuant tochapter 395 for 380 its employees, the board may approve up to 1 hour of the 2-hour 381 course to be specifically related to error reduction and 382 prevention methods used in that facility. 383 (b) As a condition of initial licensure and at each 384 subsequent license renewal, the boards, or the department if 385 there is no board, shall allow each practitioner licensed under 386 chapter 458, chapter 459, chapter 461, chapter 465, or chapter 387 466 whose lawful scope of practice authorizes the practitioner 388 to prescribe, administer, or dispense controlled substances to 389 complete a 1-hour continuing education course relating to the 390 prescription drug monitoring program. The course must include, 391 but need not be limited to: 392 1. The purpose of the prescription drug monitoring program. 393 2. The practitioners’ capabilities for improving the 394 standard of care for patients by using the prescription drug 395 monitoring program. 396 3. How the prescription drug monitoring program can help 397 practitioners detect doctor shopping. 398 4. The involvement of law enforcement personnel, the 399 Attorney General’s Medicaid Fraud Unit, and medical regulatory 400 investigators with the prescription drug monitoring program. 401 5. The procedures for registering for access to the 402 prescription drug monitoring program. 403 404 The course hours may be included in the total number of hours of 405 continuing education required by the profession and must be 406 approved by the board or by the department if there is no board. 407 The boards, or the department if there is no board, shall 408 approve the course offered through a facility licensed under 409 chapter 395 for its employees if the course is at least 3 hours 410 and covers the education requirements. 411 (c) The course requirements in paragraph (b) apply to each 412 licensee renewing his or her license on or after July 1, 2012, 413 and to each applicant approved for licensure on or after January 414 1, 2013. 415 (d) By October 1, 2011, the boards, or the department if 416 there is no board, shall adopt rules as necessary to administer 417 this subsection. 418 Section 3. Section 458.305, Florida Statutes, is amended to 419 read: 420 458.305 Definitions.—As used in this chapter: 421 (1) “Board” means the Board of Medicine. 422 (2) “Department” means the Department of Health. 423 (3) “Dispensing physician” means a physician who is 424 registered as a dispensing practitioner under s. 465.0276. 425 (4)(3)“Practice of medicine” means the diagnosis, 426 treatment, operation, or prescription for any human disease, 427 pain, injury, deformity, or other physical or mental condition. 428 (5)(4)“Physician” means a person who is licensed to 429 practice medicine in this state. 430 Section 4. Advertising of controlled substances by a 431 dispensing physician.— 432 (1)(a) Only a dispensing physician licensed under chapter 433 458 or chapter 459, Florida Statutes, may use the title 434 “dispensing physician” or “dispenser” or otherwise lead the 435 public to believe that he or she is engaged in the dispensing of 436 controlled substances. 437 (b) A person, other than an owner of a: 438 1. Pain-management clinic registered under chapter 458 or 439 chapter 459, Florida Statutes; or 440 2. Health clinic licensed under chapter 400, Florida 441 Statutes, 442 443 may not display any sign or take any other action that would 444 lead the public to believe that such person is engaged in the 445 business of dispensing a controlled substance. Any advertisement 446 that states “dispensing onsite” or “onsite pharmacy” violates 447 this paragraph. This paragraph does not preclude a person who is 448 not licensed as a medical practitioner from owning a pain 449 management clinic. 450 (c) A person, firm, or corporation, unless licensed under 451 chapter 465, Florida Statutes, may not use in a trade name, 452 sign, letter, or advertisement any term, including “drug,” 453 “pharmacy,” “onsite pharmacy,” “dispensing,” “dispensing 454 onsite,” “prescription drugs,” “Rx,” or “apothecary,” which 455 implies that the person, firm, or corporation is licensed or 456 registered to dispense prescription drugs in this state. 457 (2) A person who violates paragraph (1)(a) or paragraph 458 (1)(b) commits a misdemeanor of the first degree, punishable as 459 provided in s. 775.082 or s. 775.083, Florida Statutes. A person 460 who violates paragraph (1)(c) commits a felony of the third 461 degree, punishable as provided in s. 775.082, s. 775.083, or s. 462 775.084, Florida Statutes. In any warrant, information, or 463 indictment, it is not necessary to negate any exceptions, and 464 the burden of any exception is upon the defendant. 465 Section 5. Paragraph (a) of subsection (1) of section 466 458.3191, Florida Statutes, is amended to read: 467 458.3191 Physician survey.— 468 (1) Each person who applies for licensure renewal as a 469 physician under this chapter or chapter 459 must, in conjunction 470 with the renewal of such license under procedures adopted by the 471 Department of Health and in addition to any other information 472 that may be required from the applicant, furnish the following 473 to the Department of Health in a physician survey: 474 (a) Licensee information, including, but not limited to: 475 1. Frequency and geographic location of practice within the 476 state. 477 2. Practice setting. 478 3. Percentage of time spent in direct patient care. 479 4. Anticipated change to license or practice status. 480 5. Areas of specialty or certification. 481 6. Whether the department has ever approved or denied the 482 physician’s registration for access to a patient’s information 483 in the prescription drug monitoring program’s database. 484 7. Whether the physician uses the prescription drug 485 monitoring program with patients in his or her medical practice. 486 Section 6. Subsection (3) is added to section 458.3192, 487 Florida Statutes, to read: 488 458.3192 Analysis of survey results; report.— 489 (3) By November 1 each year, the Department of Health shall 490 provide nonidentifying information to the prescription drug 491 monitoring program’s Implementation and Oversight Task Force 492 regarding the number of physicians who are registered with the 493 prescription drug monitoring program and who also use the 494 database from the prescription drug monitoring program for their 495 patients in their medical practice. 496 Section 7. Paragraph (a) of subsection (1) and paragraphs 497 (a) and (c) of subsection (2) of section 458.3265, Florida 498 Statutes, are amended, and paragraphs (f) and (g) are added to 499 subsection (5) of that section, to read: 500 458.3265 Pain-management clinics.— 501 (1) REGISTRATION.— 502 (a) All privately owned pain-management clinics, 503 facilities, or offices, hereinafter referred to as “clinics,” 504 which advertise in any medium for any type of pain-management 505 services, or employ a physician who is primarily engaged in the 506 treatment of pain by prescribing or dispensing controlled 507 substance medications, must register with the department unless: 508 1. That clinic is licensed as a facility pursuant to 509 chapter 395; 510 2. The majority of the physicians who provide services in 511 the clinic primarily provide surgical services or interventional 512 pain procedures of the type routinely billed using surgical 513 codes; 514 3. The clinic is owned by a publicly held corporation whose 515 shares are traded on a national exchange or on the over-the 516 counter market and whose total assets at the end of the 517 corporation’s most recent fiscal quarter exceeded $50 million; 518 4. The clinic is affiliated with an accredited medical 519 school at which training is provided for medical students, 520 residents, or fellows; 521 5. The clinic does not prescribe or dispense controlled 522 substances for the treatment of pain; or 523 6. The clinic is owned by a corporate entity exempt from 524 federal taxation under 26 U.S.C. s. 501(c)(3). 525 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities 526 apply to any physician who provides professional services in a 527 pain-management clinic that is required to be registered in 528 subsection (1). 529 (a) A physician may not practice medicine in a pain 530 management clinic, as described in subsection (4), if:5311.the pain-management clinic is not registered with the 532 department as required by this section.; or5332. Effective July 1, 2012, the physician has not534successfully completed a pain-medicine fellowship that is535accredited by the Accreditation Council for Graduate Medical536Education or a pain-medicine residency that is accredited by the537Accreditation Council for Graduate Medical Education or, prior538to July 1, 2012, does not comply with rules adopted by the539board.540 541 Any physician who qualifies to practice medicine in a pain 542 management clinic pursuant to rules adopted by the Board of 543 Medicine as of July 1, 2012, may continue to practice medicine 544 in a pain-management clinic as long as the physician continues 545 to meet the qualifications set forth in the board rules. A 546 physician who violates this paragraph is subject to disciplinary 547 action by his or her appropriate medical regulatory board. 548 (c) A physician, an advanced registered nurse practitioner, 549 or a physician assistant must perform an appropriate medicala550physicalexamination of a patient on the same day that the 551 physicianhe or shedispenses or prescribes a controlled 552 substance to a patient at a pain-management clinic. If the 553 physician prescribes or dispenses more than a 72-hour dose of 554 controlled substances for the treatment of chronic nonmalignant 555 pain, the physician must document in the patient’s record the 556 reason such dosage is within the standard of care. For the 557 purpose of this paragraph, the standard of care is set forth in 558 rule 64B8-9.013(3), Florida Administrative Codefor prescribing559or dispensing that quantity. 560 (5) PENALTIES; ENFORCEMENT.— 561 (f) A licensee or other person who serves as the designated 562 physician of a pain-management clinic as defined in this section 563 or s. 459.0137 and registers a pain-management clinic through 564 misrepresentation or fraud or procures or attempts to procure 565 the registration of a pain-management clinic for any other 566 person by making or causing to be made any false or fraudulent 567 representation commits a felony of the third degree, punishable 568 as provided in s. 775.082, s. 775.083, or s. 775.084. 569 (g) Any person who registers a pain-management clinic 570 through misrepresentation or fraud or who procures or attempts 571 to procure the registration of a pain-management clinic for any 572 other person by making or causing to be made any false or 573 fraudulent representation, commits a felony of the third degree, 574 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 575 Section 8. Paragraphs (f) and (g) are added to subsection 576 (1), paragraphs (g) and (h) are added to subsection (2), and 577 subsection (3) is added to section 458.327, Florida Statutes, to 578 read: 579 458.327 Penalty for violations.— 580 (1) Each of the following acts constitutes a felony of the 581 third degree, punishable as provided in s. 775.082, s. 775.083, 582 or s. 775.084: 583 (f) Failing to perform a physical examination of a patient 584 by a physician or a licensed designee acting under the 585 physician’s supervision on the same day that the treating 586 physician dispenses or prescribes a controlled substance to the 587 patient at a pain-management clinic occurring three or more 588 times within a 6-month period, or failing to perform a physical 589 examination on three or more different patients on the same day 590 that the treating physician dispenses or prescribes a controlled 591 substance to each patient at a pain-management clinic within a 592 6-month period. 593 (g) Prescribing or dispensing in excess of a 72-hour dose 594 of controlled substances at a pain-management clinic for the 595 treatment of chronic nonmalignant pain of a patient occurring 596 three or more times within a 6-month period without documenting 597 in the patient’s record the reason that such dosage is within 598 the standard of care. For the purpose of this paragraph, the 599 standard of care is set forth in rule 64B8-9.013(3), Florida 600 Administrative Code. 601 (2) Each of the following acts constitutes a misdemeanor of 602 the first degree, punishable as provided in s. 775.082 or s. 603 775.083: 604 (g) Failing to perform a physical examination of a patient 605 on the same day that the treating physician dispenses or 606 prescribes a controlled substance to the patient at a pain 607 management clinic two times in a 6-month period, or failing to 608 perform a physical examination on two different patients on the 609 same day that the treating physician dispenses or prescribes a 610 controlled substance to each patient at a pain-management clinic 611 within a 6-month period. 612 (h) Prescribing or dispensing in excess of a 72-hour dose 613 of controlled substances at a pain-management clinic for the 614 treatment of chronic nonmalignant pain of a patient occurring 615 two times within a 6-month period without documenting in the 616 patient’s record the reason that such dosage is within the 617 standard of care. For the purpose of this paragraph, the 618 standard of care is set forth in rule 64B8-9.013(3), Florida 619 Administrative Code. 620 (3) Each of the following acts constitutes a misdemeanor of 621 the second degree, punishable as provided in s. 775.082 or s. 622 775.083: 623 (a) A first offense of failing to perform a physical 624 examination of a patient on the same day that the treating 625 physician dispenses or prescribes a controlled substance to the 626 patient at a pain-management clinic. 627 (b) A first offense of failing to document in a patient’s 628 record the reason that such dosage is within the standard of 629 care for prescribing or dispensing in excess of a 72-hour dose 630 of controlled substances at a pain-management clinic for the 631 treatment of chronic nonmalignant pain. 632 Section 9. Subsection (11) is added to section 458.331, 633 Florida Statutes, to read: 634 458.331 Grounds for disciplinary action; action by the 635 board and department.— 636 (11) Notwithstanding subsection (2), upon finding that a 637 physician has prescribed or dispensed, or caused to be 638 prescribed or dispensed, a controlled substance in a pain 639 management clinic in a manner that violates the standard of 640 practice as set forth in this chapter or rules adopted pursuant 641 to this chapter, the board shall, at a minimum, suspend the 642 physician’s license for at least 6 months and impose a fine of 643 at least $10,000 per count. Repeated violations shall result in 644 increased penalties. 645 Section 10. Present subsections (3), (4), and (5) of 646 section 459.003, Florida Statutes, are redesignated as 647 subsections (4), (5), and (6), respectively, and a new 648 subsection (3) is added to that section, to read: 649 459.003 Definitions.—As used in this chapter: 650 (3) “Dispensing physician” means an osteopathic physician 651 who is registered as a dispensing practitioner under s. 652 465.0276. 653 Section 11. Paragraphs (f) and (g) are added to subsection 654 (1), paragraphs (e) and (f) are added to subsection (2), and 655 paragraphs (d) and (e) are added to subsection (3) of section 656 459.013, Florida Statutes, to read: 657 459.013 Penalty for violations.— 658 (1) Each of the following acts constitutes a felony of the 659 third degree, punishable as provided in s. 775.082, s. 775.083, 660 or s. 775.084: 661 (f) Failing to perform a physical examination of a patient 662 on the same day that the osteopathic physician dispenses or 663 prescribes a controlled substance to the patient at a pain 664 management clinic occurring three or more times within a 6-month 665 period, or failing to perform a physical examination on three or 666 more different patients on the same day that the osteopathic 667 physician dispenses or prescribes a controlled substance to each 668 patient at a pain-management clinic within a 6-month period. 669 (g) Prescribing or dispensing in excess of a 72-hour dose 670 of controlled substances at a pain-management clinic for the 671 treatment of chronic nonmalignant pain of a patient occurring 672 three or more times within a 6-month period without documenting 673 in the patient’s record the reason that such dosage is within 674 the standard of care. For the purpose of this paragraph, the 675 standard of care is set forth in rule 64B8-9.013(3), Florida 676 Administrative Code. 677 (2) Each of the following acts constitutes a misdemeanor of 678 the first degree, punishable as provided in s. 775.082 or s. 679 775.083: 680 (e) Failing to perform a physical examination of a patient 681 on the same day that the osteopathic physician dispenses or 682 prescribes a controlled substance to the patient at a pain 683 management clinic occurring two times within a 6-month period, 684 or failing to perform a physical examination on two different 685 patients on the same day that the osteopathic physician 686 dispenses or prescribes a controlled substance to each patient 687 at a pain-management clinic within a 6-month period. 688 (f) Prescribing or dispensing in excess of a 72-hour dose 689 of controlled substances at a pain-management clinic for the 690 treatment of chronic nonmalignant pain of a patient occurring 691 two times within a 6-month period without documenting in the 692 patient’s record the reason that such dosage is within the 693 standard of care. For the purpose of this paragraph, the 694 standard of care is set forth in rule 64B8-9.013(3), Florida 695 Administrative Code. 696 (3) Each of the following constitutes a misdemeanor of the 697 second degree, punishable as provided in s. 775.082 or s. 698 775.083: 699 (d) A first offense of failing to perform a physical 700 examination of a patient on the same day that the osteopathic 701 physician dispenses or prescribes a controlled substance to the 702 patient at a pain-management clinic. 703 (e) A first offense of failing to document in a patient’s 704 record the reason that such dosage is within the standard of 705 care for prescribing or dispensing in excess of a 72-hour dose 706 of controlled substances at a pain-management clinic for the 707 treatment of chronic nonmalignant pain. For the purpose of this 708 paragraph, the standard of care is set forth in rule 64B8 709 9.013(3), Florida Administrative Code. 710 Section 12. Paragraph (a) of subsection (1) and paragraph 711 (c) of subsection (2) of section 459.0137, Florida Statutes, are 712 amended, and paragraphs (f) and (g) are added to subsection (5) 713 of that section, to read: 714 459.0137 Pain-management clinics.— 715 (1) REGISTRATION.— 716 (a) All privately owned pain-management clinics, 717 facilities, or offices, hereinafter referred to as “clinics,” 718 which advertise in any medium for any type of pain-management 719 services, or employ an osteopathic physician who is primarily 720 engaged in the treatment of pain by prescribing or dispensing 721 controlled substance medications, must register with the 722 department unless: 723 1. That clinic is licensed as a facility pursuant to 724 chapter 395; 725 2. The majority of the physicians who provide services in 726 the clinic primarily provide surgical services or interventional 727 pain procedures of the type routinely billed using surgical 728 codes; 729 3. The clinic is owned by a publicly held corporation whose 730 shares are traded on a national exchange or on the over-the 731 counter market and whose total assets at the end of the 732 corporation’s most recent fiscal quarter exceeded $50 million; 733 4. The clinic is affiliated with an accredited medical 734 school at which training is provided for medical students, 735 residents, or fellows; 736 5. The clinic does not prescribe or dispense controlled 737 substances for the treatment of pain; or 738 6. The clinic is owned by a corporate entity exempt from 739 federal taxation under 26 U.S.C. s. 501(c)(3). 740 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities 741 apply to any osteopathic physician who provides professional 742 services in a pain-management clinic that is required to be 743 registered in subsection (1). 744 (c) An osteopathic physician, an advanced registered nurse 745 practitioner, or a physician assistant must perform an 746 appropriate medicala physicalexamination of a patient on the 747 same day that the physicianhe or shedispenses or prescribes a 748 controlled substance to a patient at a pain-management clinic. 749 If the osteopathic physician prescribes or dispenses more than a 750 72-hour dose of controlled substances for the treatment of 751 chronic nonmalignant pain, the osteopathic physician must 752 document in the patient’s record the reason for which 753 prescribing or dispensing a dosage in excess of a 72-hour dose 754 of controlled substances for the treatment of chronic 755 nonmalignant pain is within the standard of carefor prescribing756or dispensing that quantity. 757 (5) PENALTIES; ENFORCEMENT.— 758 (f) A licensee or other person who serves as the designated 759 physician of a pain-management clinic as defined in s. 458.3265 760 or s. 459.0137 and registers a pain-management clinic through 761 intentional misrepresentation or fraud or procures or attempts 762 to procure the registration of a pain-management clinic for any 763 other person by making or causing to be made any false or 764 fraudulent representation commits a felony of the third degree, 765 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 766 (g) Any person who registers a pain-management clinic 767 through misrepresentation or fraud or who procures or attempts 768 to procure the registration of a pain-management clinic for any 769 other person by making or causing to be made any false or 770 fraudulent representation, commits a felony of the third degree, 771 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 772 Section 13. Subsection (11) is added to section 459.015, 773 Florida Statutes, to read: 774 459.015 Grounds for disciplinary action; action by the 775 board and department.— 776 (11) Notwithstanding subsection (2), upon finding that an 777 osteopathic physician has prescribed or dispensed, or caused to 778 be prescribed or dispensed, a controlled substance in a pain 779 management clinic in a manner that violates the standard of 780 practice as set forth in this chapter or rules adopted pursuant 781 to this chapter, the board shall, at a minimum, suspend the 782 osteopathic physician’s license for at least 6 months and impose 783 a fine of at least $10,000 per count. Repeated violations shall 784 result in increased penalties. 785 Section 14. Present subsections (3) and (4) of section 786 465.015, Florida Statutes, are renumbered as subsections (4) and 787 (5), respectively, and a new subsection (3) is added to that 788 section, to read: 789 465.015 Violations and penalties.— 790 (3)(a) A licensed pharmacist or other person employed by or 791 at a pharmacy may not knowingly fail to timely report to the 792 local county sheriff’s office the name of any person who obtains 793 or attempts to obtain a substance controlled by s. 893.03 which 794 the licensed pharmacist or other person employed by or at the 795 pharmacy knows or reasonably should have known was obtained or 796 attempted to be obtained from the pharmacy through any 797 fraudulent method or representation. A licensed pharmacist or 798 other person employed by or at a pharmacy who fails to make such 799 a report within 24 hours after learning of the fraud or 800 attempted fraud commits a misdemeanor of the first degree, 801 punishable as provided in s. 775.082 or s. 775.083. 802 (b) A sufficient report of the fraudulent obtaining of or 803 attempt to obtain a controlled substance under this subsection 804 must contain, at a minimum, a copy of the prescription used or 805 presented and a narrative, including all information available 806 to the pharmacy regarding: 807 1. The transaction, such as the name and telephone number 808 of the prescribing physician; 809 2. The name, description, and any personal identification 810 information pertaining to the person presenting the 811 prescription; and 812 3. All other material information, such as photographic or 813 video surveillance of the transaction. 814 815 A licensed pharmacist or other person employed by or at a 816 pharmacy is not subject to disciplinary action for reporting 817 under this subsection. 818 Section 15. Subsection (6) is added to section 465.0276, 819 Florida Statutes, to read: 820 465.0276 Dispensing practitioner.— 821 (6) In order to dispense a controlled substance listed in 822 Schedule II, Schedule III, or Schedule IV in s. 893.03, a 823 practitioner authorized by law to prescribe a controlled 824 substance shall register with the Board of Pharmacy as a 825 dispensing practitioner who dispenses controlled substances and 826 pay a fee not to exceed $100. The department shall adopt rules 827 establishing procedures for renewal of the registration every 4 828 years. 829 Section 16. Paragraph (a) of subsection (1) of section 830 766.101, Florida Statutes, is amended to read: 831 766.101 Medical review committee, immunity from liability.— 832 (1) As used in this section: 833 (a) The term “medical review committee” or “committee” 834 means: 835 1.a. A committee of a hospital or ambulatory surgical 836 center licensed under chapter 395 or a health maintenance 837 organization certificated under part I of chapter 641, 838 b. A committee of a physician-hospital organization, a 839 provider-sponsored organization, or an integrated delivery 840 system, 841 c. A committee of a state or local professional society of 842 health care providers, 843 d. A committee of a medical staff of a licensed hospital or 844 nursing home, provided the medical staff operates pursuant to 845 written bylaws that have been approved by the governing board of 846 the hospital or nursing home, 847 e. A committee of the Department of Corrections or the 848 Correctional Medical Authority as created under s. 945.602, or 849 employees, agents, or consultants of either the department or 850 the authority or both, 851 f. A committee of a professional service corporation formed 852 under chapter 621 or a corporation organized under chapter 607 853 or chapter 617, which is formed and operated for the practice of 854 medicine as defined in s. 458.305(4)s.458.305(3), and which 855 has at least 25 health care providers who routinely provide 856 health care services directly to patients, 857 g. A committee of the Department of Children and Family 858 Services which includes employees, agents, or consultants to the 859 department as deemed necessary to provide peer review, 860 utilization review, and mortality review of treatment services 861 provided pursuant to chapters 394, 397, and 916, 862 h. A committee of a mental health treatment facility 863 licensed under chapter 394 or a community mental health center 864 as defined in s. 394.907, provided the quality assurance program 865 operates pursuant to the guidelines which have been approved by 866 the governing board of the agency, 867 i. A committee of a substance abuse treatment and education 868 prevention program licensed under chapter 397 provided the 869 quality assurance program operates pursuant to the guidelines 870 which have been approved by the governing board of the agency, 871 j. A peer review or utilization review committee organized 872 under chapter 440, 873 k. A committee of the Department of Health, a county health 874 department, healthy start coalition, or certified rural health 875 network, when reviewing quality of care, or employees of these 876 entities when reviewing mortality records, or 877 l. A continuous quality improvement committee of a pharmacy 878 licensed pursuant to chapter 465, 879 880 which committee is formed to evaluate and improve the quality of 881 health care rendered by providers of health service, to 882 determine that health services rendered were professionally 883 indicated or were performed in compliance with the applicable 884 standard of care, or that the cost of health care rendered was 885 considered reasonable by the providers of professional health 886 services in the area; or 887 2. A committee of an insurer, self-insurer, or joint 888 underwriting association of medical malpractice insurance, or 889 other persons conducting review under s. 766.106. 890 Section 17. Subsection (3) of section 810.02, Florida 891 Statutes, is amended to read: 892 810.02 Burglary.— 893 (3) Burglary is a felony of the second degree, punishable 894 as provided in s. 775.082, s. 775.083, or s. 775.084, if, in the 895 course of committing the offense, the offender does not make an 896 assault or battery and is not and does not become armed with a 897 dangerous weapon or explosive, and the offender enters or 898 remains in a: 899 (a) Dwelling, and there is another person in the dwelling 900 at the time the offender enters or remains; 901 (b) Dwelling, and there is not another person in the 902 dwelling at the time the offender enters or remains; 903 (c) Structure, and there is another person in the structure 904 at the time the offender enters or remains; 905 (d) Conveyance, and there is another person in the 906 conveyance at the time the offender enters or remains;or907 (e) Authorized emergency vehicle, as defined in s. 316.003; 908 or.909 (f) Structure or conveyance when the offense intended to be 910 committed is theft of a substance controlled by s. 893.03. 911 Notwithstanding any contrary provisions of law, separate 912 judgments and sentences for burglary with the intent to commit 913 theft of a controlled substance under this paragraph and for any 914 applicable offense for possession of a controlled substance 915 under s. 893.13, or an offense for trafficking in a controlled 916 substance under s. 893.135, may be imposed if all such offenses 917 involve the same amount or amounts of a controlled substance. 918 919 However, if the burglary is committed within a county that is 920 subject to a state of emergency declared by the Governor under 921 chapter 252 after the declaration of emergency is made and the 922 perpetration of the burglary is facilitated by conditions 923 arising from the emergency, the burglary is a felony of the 924 first degree, punishable as provided in s. 775.082, s. 775.083, 925 or s. 775.084. As used in this subsection, the term “conditions 926 arising from the emergency” means civil unrest, power outages, 927 curfews, voluntary or mandatory evacuations, or a reduction in 928 the presence of or response time for first responders or 929 homeland security personnel. A person arrested for committing a 930 burglary within a county that is subject to such a state of 931 emergency may not be released until the person appears before a 932 committing magistrate at a first appearance hearing. For 933 purposes of sentencing under chapter 921, a felony offense that 934 is reclassified under this subsection is ranked one level above 935 the ranking under s. 921.0022 or s. 921.0023 of the offense 936 committed. 937 Section 18. Paragraph (c) of subsection (2) of section 938 812.014, Florida Statutes, is amended to read: 939 812.014 Theft.— 940 (2) 941 (c) It is grand theft of the third degree and a felony of 942 the third degree, punishable as provided in s. 775.082, s. 943 775.083, or s. 775.084, if the property stolen is: 944 1. Valued at $300 or more, but less than $5,000. 945 2. Valued at $5,000 or more, but less than $10,000. 946 3. Valued at $10,000 or more, but less than $20,000. 947 4. A will, codicil, or other testamentary instrument. 948 5. A firearm. 949 6. A motor vehicle, except as provided in paragraph (a). 950 7. Any commercially farmed animal, including any animal of 951 the equine, bovine, or swine class, or other grazing animal, and 952 including aquaculture species raised at a certified aquaculture 953 facility. If the property stolen is aquaculture species raised 954 at a certified aquaculture facility, then a $10,000 fine shall 955 be imposed. 956 8. Any fire extinguisher. 957 9. Any amount of citrus fruit consisting of 2,000 or more 958 individual pieces of fruit. 959 10. Taken from a designated construction site identified by 960 the posting of a sign as provided for in s. 810.09(2)(d). 961 11. Any stop sign. 962 12. Anhydrous ammonia. 963 13. Any amount of a substance controlled by s. 893.03. 964 Notwithstanding any contrary provisions of law, separate 965 judgments and sentences for theft of a controlled substance 966 under this subparagraph, and for any applicable offense for 967 possession of a controlled substance under s. 893.13, or an 968 offense for trafficking in a controlled substance under s. 969 893.135 may be imposed if all such offenses involve the same 970 amount or amounts of controlled substance. 971 972 However, if the property is stolen within a county that is 973 subject to a state of emergency declared by the Governor under 974 chapter 252, the property is stolen after the declaration of 975 emergency is made, and the perpetration of the theft is 976 facilitated by conditions arising from the emergency, the 977 offender commits a felony of the second degree, punishable as 978 provided in s. 775.082, s. 775.083, or s. 775.084, if the 979 property is valued at $5,000 or more, but less than $10,000, as 980 provided under subparagraph 2., or if the property is valued at 981 $10,000 or more, but less than $20,000, as provided under 982 subparagraph 3. As used in this paragraph, the term “conditions 983 arising from the emergency” means civil unrest, power outages, 984 curfews, voluntary or mandatory evacuations, or a reduction in 985 the presence of or the response time for first responders or 986 homeland security personnel. For purposes of sentencing under 987 chapter 921, a felony offense that is reclassified under this 988 paragraph is ranked one level above the ranking under s. 989 921.0022 or s. 921.0023 of the offense committed. 990 Section 19. Section 893.021, Florida Statutes, is created 991 to read: 992 893.021 Adulterated drug.— 993 (1) As used in this chapter, a drug is adulterated if it is 994 a controlled substance that: 995 (a) Has been produced, prepared, packed, and marketed for 996 oral consumption by the manufacturer; and 997 (b) Has had any change to its integrity or composition for 998 use by means of inhalation, injection, or any other form of 999 ingestion not in accordance with the manufacturer’s recommended 1000 use, and such mode of use has not been previously directed and 1001 approved by the prescribing physician. 1002 (2) A physician is not prevented from directing or 1003 prescribing a change to the recognized manufactured 1004 recommendations for use in a patient who presents a medical need 1005 for such a requirement change of any controlled substance. The 1006 prescribing physician shall clearly indicate any deviation of 1007 the recognized manufacturer’s recommended use of a controlled 1008 substance on the original prescription, and the licensed 1009 pharmacist shall clearly indicate such deviation on the label of 1010 the prescription upon dispensing the controlled substance. 1011 Section 20. Paragraphs (c), (d), and (e) of subsection (1) 1012 of section 893.04, Florida Statutes, are amended to read: 1013 893.04 Pharmacist and practitioner.— 1014 (1) A pharmacist, in good faith and in the course of 1015 professional practice only, may dispense controlled substances 1016 upon a written or oral prescription of a practitioner, under the 1017 following conditions: 1018 (c) The following information mustThere shallappear on 1019 the face of the prescription or written record of athereof for1020thecontrolled substancethe following information: 1021 1. The full name and address of the person for whom, or the 1022 owner of the animal for which, the controlled substance is 1023 dispensed. 1024 2. The full name and address of the prescribing 1025 practitioner and the practitioner’s federal controlled substance 1026 registry number shall be printed thereon. 1027 3. If the prescription is for an animal, the species of 1028 animal for which the controlled substance is prescribed. 1029 4. The name of the controlled substance prescribed and the 1030 strength, quantity, and directions for use thereof. The 1031 directions for use must specify the authorization by the 1032 physician, any instructions requiring the adulteration of the 1033 dispensed form of the medication, and the medical necessity for 1034 the adulteration in accordance with s. 893.021. 1035 5. The number of the prescription, as recorded in the 1036 prescription files of the pharmacy in which it is filled. 1037 6. The initials of the pharmacist filling the prescription 1038 and the date filled. 1039 (d) The prescription mustshallbe retained on file by the 1040 proprietor of the pharmacy in which it is filled for a period of 1041 2 years. 1042 (e) A label bearing the following information must be 1043 affixed to the original container in which a controlled 1044 substance is delivered asupona prescription or authorized 1045 refillthereof, as hereinafter provided, there shall be a label1046bearing the following information: 1047 1. The name and address of the pharmacy from which such 1048 controlled substance was dispensed. 1049 2. The date on which the prescription for such controlled 1050 substance was filled. 1051 3. The number of such prescription, as recorded in the 1052 prescription files of the pharmacy in which it is filled. 1053 4. The name of the prescribing practitioner. 1054 5. The name of the patient for whom, or of the owner and 1055 species of the animal for which, the controlled substance is 1056 prescribed. 1057 6. The directions for the use of the controlled substance 1058 prescribed in the prescription. 1059 7. A clear, concise warning that it is a crime to transfer 1060 the controlled substance to any person other than the patient 1061 for whom prescribed. 1062 Section 21. Section 893.055, Florida Statutes, is amended 1063 to read: 1064 893.055 Prescription drug monitoring program.— 1065 (1) As used in this section, the term: 1066 (a) “Patient advisory report” or “advisory report” means 1067 information provided by the department in writing, or as 1068 determined by the department, to a prescriber, dispenser, 1069 pharmacy, or patient concerning the dispensing of controlled 1070 substances. All advisory reports are for informational purposes 1071 only and impose no obligations of any nature or any legal duty 1072 on a prescriber, dispenser, pharmacy, or patient. The patient 1073 advisory report shall be provided in accordance with s. 1074 893.13(7)(a)8. The advisory reports issued by the department are 1075 not subject to discovery or introduction into evidence in any 1076 civil or administrative action against a prescriber, dispenser, 1077 pharmacy, or patient arising out of matters that are the subject 1078 of the report; and a person who participates in preparing, 1079 reviewing, issuing, or any other activity related to an advisory 1080 report may not be permitted or required to testify in any such 1081 civil action as to any findings, recommendations, evaluations, 1082 opinions, or other actions taken in connection with preparing, 1083 reviewing, or issuing such a report. 1084 (b) “Controlled substance” means a controlled substance 1085 listed in Schedule II, Schedule III, or Schedule IV in s. 1086 893.03. 1087 (c) “Dispenser” means a pharmacy, dispensing pharmacist, or 1088 dispensing health care practitioner. 1089 (d) “Health care practitioner” or “practitioner” means any 1090 practitioner who is subject to licensure or regulation by the 1091 department under chapter 458, chapter 459, chapter 461, chapter 1092 462, chapter 464, chapter 465, or chapter 466. 1093 (e) “Health care regulatory board” means any board for a 1094 practitioner or health care practitioner who is licensed or 1095 regulated by the department. 1096 (f) “Pharmacy” means any pharmacy that is subject to 1097 licensure or regulation by the department under chapter 465 and 1098 that dispenses or delivers a controlled substance to an 1099 individual or address in this state. 1100 (g) “Prescriber” means a prescribing physician, prescribing 1101 practitioner, or other prescribing health care practitioner. 1102 (h) “Active investigation” means an investigation that is 1103 being conducted with a reasonable, good faith belief that it 1104 could lead to the filing of administrative, civil, or criminal 1105 proceedings, or that is ongoing and continuing and for which 1106 there is a reasonable, good faith anticipation of securing an 1107 arrest or prosecution in the foreseeable future. 1108 (i) “Law enforcement agency” means the Department of Law 1109 Enforcement, a Florida sheriff’s department, a Florida police 1110 department, or a law enforcement agency of the Federal 1111 Government which enforces the laws of this state or the United 1112 States relating to controlled substances, and which its agents 1113 and officers are empowered by law to conduct criminal 1114 investigations and make arrests. 1115 (j) “Program manager” means an employee of or a person 1116 contracted by the Department of Health who is designated to 1117 ensure the integrity of the prescription drug monitoring program 1118 in accordance with the requirements established in paragraphs 1119 (2)(a) and (b). 1120 (2)(a) By December 1, 2010, the department shall design and 1121 establish a comprehensive electronic database system that has 1122 controlled substance prescriptions provided to it and that 1123 provides prescription information to a patient’s health care 1124 practitioner and pharmacist who inform the department that they 1125 wish the patient advisory report provided to them. Otherwise, 1126 the patient advisory report will not be sent to the 1127 practitioner, pharmacy, or pharmacist. The system shall be 1128 designed to provide information regarding dispensed 1129 prescriptions of controlled substances and shall not infringe 1130 upon the legitimate prescribing or dispensing of a controlled 1131 substance by a prescriber or dispenser acting in good faith and 1132 in the course of professional practice. The system shall be 1133 consistent with standards of the American Society for Automation 1134 in Pharmacy (ASAP). The electronic system shall also comply with 1135 the Health Insurance Portability and Accountability Act (HIPAA) 1136 as it pertains to protected health information (PHI), electronic 1137 protected health information (EPHI), the National All Schedules 1138 Prescription Electronic Reporting (NASPER) Act’s minimum 1139 requirements for authentication of a practitioner who requests 1140 information in the prescription drug monitoring program database 1141 and certification of the purpose for which information is 1142 requested, and all other relevant state and federal privacy and 1143 security laws and regulations. The department shall establish 1144 policies and procedures as appropriate regarding the reporting, 1145 accessing the database, evaluation, management, development, 1146 implementation, operation, storage, and security of information 1147 within the system. The reporting of prescribed controlled 1148 substances shall include a dispensing transaction with a 1149 dispenser pursuant to chapter 465 or through a dispensing 1150 transaction to an individual or address in this state with a 1151 pharmacy that is not located in this state but that is otherwise 1152 subject to the jurisdiction of this state as to that dispensing 1153 transaction. The reporting of patient advisory reports refers 1154 only to reports to patients, pharmacies, and practitioners. 1155 Separate reports that contain patient prescription history 1156 information and that are not patient advisory reports are 1157 provided to persons and entities as authorized in paragraphs 1158 (7)(b) and (c) and s. 893.0551. 1159 (b) The department, when the direct support organization 1160 receives at least $20,000 in nonstate moneys or the state 1161 receives at least $20,000 in federal grants for the prescription 1162 drug monitoring program, and in consultation with the Office of 1163 Drug Control, shall adopt rules as necessary concerning the 1164 reporting, accessing the database, evaluation, management, 1165 development, implementation, operation, security, and storage of 1166 information within the system, including rules for when patient 1167 advisory reports are provided to pharmacies and prescribers. The 1168 patient advisory report shall be provided in accordance with s. 1169 893.13(7)(a)8. The department shall work with the professional 1170 health care licensure boards, such as the Board of Medicine, the 1171 Board of Osteopathic Medicine, and the Board of Pharmacy; other 1172 appropriate organizations, such as the Florida Pharmacy 1173 Association, the Office of Drug Control, the Florida Medical 1174 Association, the Florida Retail Federation, and the Florida 1175 Osteopathic Medical Association, including those relating to 1176 pain management; and the Attorney General, the Department of Law 1177 Enforcement, and the Agency for Health Care Administration to 1178 develop rules appropriate for the prescription drug monitoring 1179 program. 1180 (c) All dispensers and prescribers subject to these 1181 reporting requirements shall be notified by the department of 1182 the implementation date for such reporting requirements. 1183 (d) The program manager shall work with professional health 1184 care licensure boards and the stakeholders listed in paragraph 1185 (b) to develop rules appropriate for identifying indicators of 1186 controlled substance abuse. 1187 (e) The department shall establish a method to allow 1188 corrections to the database when notified by a health care 1189 practitioner or pharmacist. 1190 (3) The pharmacy dispensing the controlled substance and 1191 each prescriber who directly dispenses a controlled substance 1192 shall submit to the electronic system, by a procedure and in a 1193 format established by the department and consistent with an 1194 ASAP-approved format, the following information for inclusion in 1195 the database: 1196 (a) The name of the prescribing practitioner, the 1197 practitioner’s federal Drug Enforcement Administration 1198 registration number, the practitioner’s National Provider 1199 Identification (NPI) or other appropriate identifier, and the 1200 date of the prescription. 1201 (b) The date the prescription was filled and the method of 1202 payment, such as cash by an individual, insurance coverage 1203 through a third party, or Medicaid payment. This paragraph does 1204 not authorize the department to include individual credit card 1205 numbers or other account numbers in the database. 1206 (c) The full name, address, and date of birth of the person 1207 for whom the prescription was written. 1208 (d) The name, national drug code, quantity, and strength of 1209 the controlled substance dispensed. 1210 (e) The full name, federal Drug Enforcement Administration 1211 registration number, and address of the pharmacy or other 1212 location from which the controlled substance was dispensed. If 1213 the controlled substance was dispensed by a practitioner other 1214 than a pharmacist, the practitioner’s full name, federal Drug 1215 Enforcement Administration registration number, and address. 1216 (f) The name of the pharmacy or practitioner, other than a 1217 pharmacist, dispensing the controlled substance and the 1218 practitioner’s National Provider Identification (NPI). 1219 (g) Other appropriate identifying information as determined 1220 by department rule. 1221 (h) The number of refills ordered and whether the drug was 1222 dispensed as a refill of a prescription or was a first-time 1223 request. 1224 (4) Each time a controlled substance is dispensed to an 1225 individual, the controlled substance shall be reported to the 1226 department through the system as soon thereafter as possible, 1227 but not more than 715days after the date the controlled 1228 substance is dispensed unless an extension is approved by the 1229 department for cause as determined by rule. A dispenser must 1230 meet the reporting requirements of this section by providing the 1231 required information concerning each controlled substance that 1232 it dispensed in a department-approved, secure methodology and 1233 format. Such approved formats may include, but are not limited 1234 to, submission via the Internet, on a disc, or by use of regular 1235 mail. 1236 (5) When the following acts of dispensing or administering 1237 occur, the following are exempt from reporting under this 1238 section for that specific act of dispensing or administration: 1239 (a) A health care practitioner when administering a 1240 controlled substance directly to a patient if the amount of the 1241 controlled substance is adequate to treat the patient during 1242 that particular treatment session. 1243 (b) A pharmacist or health care practitioner when 1244 administering a controlled substance to a patient or resident 1245 receiving care as a patient at a hospital, nursing home, 1246 ambulatory surgical center, hospice, or intermediate care 1247 facility for the developmentally disabled which is licensed in 1248 this state. 1249(c) A practitioner when administering or dispensing a1250controlled substance in the health care system of the Department1251of Corrections.1252 (c)(d)A practitioner when administering a controlled 1253 substance in the emergency room of a licensed hospital. 1254 (d)(e)A health care practitioner when administering or 1255 dispensing a controlled substance to a person under the age of 1256 16 if the amount of the controlled substance is adequate to 1257 treat the patient during that particular treatment session. 1258 (e)(f)A pharmacist or a dispensing practitioner when 1259 dispensing a one-time, 48-hour72-houremergency resupply of a 1260 controlled substance to a patient. 1261 (6) The department may establish when to suspend and when 1262 to resume reporting information during a state-declared or 1263 nationally declared disaster. 1264 (7)(a) A practitioner or pharmacist who dispenses a 1265 controlled substance must submit the information required by 1266 this section in an electronic or other method in an ASAP format 1267 approved by rule of the department unless otherwise provided in 1268 this section. The cost to the dispenser in submitting the 1269 information required by this section may not be material or 1270 extraordinary. Costs not considered to be material or 1271 extraordinary include, but are not limited to, regular postage, 1272 electronic media, regular electronic mail, and facsimile 1273 charges. 1274 (b)1. In order for a pharmacy, prescriber, practitioner, or 1275 dispenser toshallhave access to information in the 1276 prescription drug monitoring program’s database which relates to 1277 a patient of that pharmacy, prescriber, practitioner, or 1278 dispenser, the pharmacy, prescriber, practitioner, or dispenser 1279 shall register with the department by submitting a registering 1280 document provided by the department. The document and validation 1281 of that document shall be determined by the department. Before a 1282 pharmacy, prescriber, practitioner, or dispenser is granted 1283 access to information in the database from the prescription drug 1284 monitoring program, the department shall approve the submitted 1285 document. Upon approval, the department shall grant the 1286 registrant access to the appropriate information in the 1287 prescription drug monitoring program’s databasein a manner1288established by the department as needed for the purpose of1289reviewing the patient’s controlled substance prescription1290history. 1291 2. Other access to the program’s database shall be limited 1292 to the program’s manager and to the designated program and 1293 support staff, who may act only at the direction of the program 1294 manager or, in the absence of the program manager, as 1295 authorized. Access by the program manager or such designated 1296 staff is for prescription drug program management only or for 1297 management of the program’s database and its system in support 1298 of the requirements of this section and in furtherance of the 1299 prescription drug monitoring program. Confidential and exempt 1300 information in the database shall be released only as provided 1301 in paragraph (c) and s. 893.0551. The program manager, 1302 designated program and support staff who act at the direction of 1303 or in the absence of the program manager, and any individual who 1304 has similar access regarding the management of the database from 1305 the prescription drug monitoring program shall submit 1306 fingerprints to the department for background screening. The 1307 department shall follow the procedure established by the 1308 Department of Law Enforcement to request a statewide criminal 1309 history record check and to request that the Department of Law 1310 Enforcement forward the fingerprints to the Federal Bureau of 1311 Investigation for a national criminal history record check. 1312 (c) The following entities mayshallnot havebe allowed1313 direct access to information in the prescription drug monitoring 1314 program database but may request from the program manager and, 1315 when authorized by the program manager, the program manager’s 1316 program and support staff, information that is confidential and 1317 exempt under s. 893.0551. Prior to release, the request shall be 1318 verified as authentic and authorized with the requesting 1319 organization by the program manager, the program manager’s 1320 program and support staff, or as determined in rules by the 1321 department as being authentic and as having been authorized by 1322 the requesting entity: 1323 1. The department or its relevant health care regulatory 1324 boards responsible for the licensure, regulation, or discipline 1325 of practitioners, pharmacists, or other persons who are 1326 authorized to prescribe, administer, or dispense controlled 1327 substances and who are involved in a specific controlled 1328 substance investigation involving a designated person for one or 1329 more prescribed controlled substances. 1330 2. The Attorney General for Medicaid fraud cases or 1331 Medicaid investigations involving prescribed controlled 1332 substances. 1333 3. A law enforcement agency during active investigations 1334 regarding potential criminal activity, fraud, or theft regarding 1335 prescribed controlled substances. 1336 4. A patient or the legal guardian or designated health 1337 care surrogate of an incapacitated patient as described in s. 1338 893.0551 who, for the purpose of verifying the accuracy of the 1339 database information, submits a written and notarized request 1340 that includes the patient’s full name, address, and date of 1341 birth, and includes the same information if the legal guardian 1342 or health care surrogate submits the request. The patient’s 1343 phone number, current address, and a copy of a government-issued 1344 photo identification must be provided in person to the program 1345 manager along with the notarized request. The request shall be 1346 validated by the department to verify the identity of the 1347 patient and the legal guardian or health care surrogate, if the 1348 patient’s legal guardian or health care surrogate is the 1349 requestor. Such verification is also required for any request to 1350 change a patient’s prescription history or other information 1351 related to his or her information in the electronic database. 1352 5. The Agency for Health Care Administration for Medicaid 1353 fraud cases or Medicaid investigations involving prescribed 1354 controlled substances. 1355 1356 Information in the database for the electronic prescription drug 1357 monitoring system is not discoverable or admissible in any civil 1358 or administrative action, except in an investigation and 1359 disciplinary proceeding by the department or the appropriate 1360 regulatory board. 1361 (d) The following entities mayshallnot havebe allowed1362 direct access to information in the prescription drug monitoring 1363 program database but may request from the program manager and, 1364 when authorized by the program manager, the program manager’s 1365 program and support staff, information that contains no 1366 identifying information of any patient, physician, health care 1367 practitioner, prescriber, or dispenser and that is not 1368 confidential and exempt: 1369 1. Department staff for the purpose of calculating 1370 performance measures pursuant to subsection (8). 1371 2. The Program Implementation and Oversight Task Force for 1372 its reporting to the Governor, the President of the Senate, and 1373 the Speaker of the House of Representatives regarding the 1374 prescription drug monitoring program. This subparagraph expires 1375 July 1, 2012. 1376 (e) All transmissions of data required by this section must 1377 comply with relevant state and federal privacy and security laws 1378 and regulations. However, any authorized agency or person under 1379 s. 893.0551 receiving such information as allowed by s. 893.0551 1380 may maintain the information received for up to 24 months before 1381 purging it from his or her records or maintain it for longer 1382 than 24 months if the information is pertinent to ongoing health 1383 care or an active law enforcement investigation or prosecution. 1384 (f) The program manager, upon determining a pattern 1385 consistent with the rules established under paragraph (2)(d) and 1386 having cause to believe a violation of s. 893.13(7)(a)8., 1387 (8)(a), or (8)(b) has occurred, may provide relevant information 1388 to the applicable law enforcement agency. 1389 (8) To assist in fulfilling program responsibilities, 1390 performance measures shall be reported annually to the Governor, 1391 the President of the Senate, and the Speaker of the House of 1392 Representatives by the department each December 1, beginning in 1393 2011. Data that does not contain patient, physician, health care 1394 practitioner, prescriber, or dispenser identifying information 1395 may be requested during the year by department employees so that 1396 the department may undertake public health care and safety 1397 initiatives that take advantage of observed trends. Performance 1398 measures may include, but are not limited to, efforts to achieve 1399 the following outcomes: 1400 (a) Reduction of the rate of inappropriate use of 1401 prescription drugs through department education and safety 1402 efforts. 1403 (b) Reduction of the quantity of pharmaceutical controlled 1404 substances obtained by individuals attempting to engage in fraud 1405 and deceit. 1406 (c) Increased coordination among partners participating in 1407 the prescription drug monitoring program. 1408 (d) Involvement of stakeholders in achieving improved 1409 patient health care and safety and reduction of prescription 1410 drug abuse and prescription drug diversion. 1411 (9) Any person who willfully and knowingly fails to report 1412 the dispensing of a controlled substance as required by this 1413 section commits a misdemeanor of the first degree, punishable as 1414 provided in s. 775.082 or s. 775.083. 1415 (10)All costs incurred by the department in administering1416the prescription drug monitoring program shall be funded through1417federal grants or private funding applied for or received by the1418state. The department may not commit funds for the monitoring1419program without ensuring funding is available. The prescription1420drug monitoring program and the implementation thereof are1421contingent upon receipt of the nonstate funding.The department 1422 and state government shall cooperate with the direct-support 1423 organization established pursuant to subsection (11) in seeking 1424 federal grant funds, other nonstate grant funds, gifts, 1425 donations, or other private moneys for the department so long as 1426 the costs of doing so are not considered material. Nonmaterial 1427 costs for this purpose include, but are not limited to, the 1428 costs of mailing and personnel assigned to research or apply for 1429 a grant. Notwithstanding the exemptions to competitive 1430 solicitation requirements under s. 287.057(3)(f), the department 1431 shall comply with the competitive-solicitation requirements 1432 under s. 287.057 for the procurement of any goods or services 1433 required by this section. 1434 (11) The Office of Drug Control, in coordination with the 1435 department, may establish a direct-support organization that has 1436 a board consisting of at least five members to provide 1437 assistance, funding, and promotional support for the activities 1438 authorized for the prescription drug monitoring program. 1439 (a) As used in this subsection, the term “direct-support 1440 organization” means an organization that is: 1441 1. A Florida corporation not for profit incorporated under 1442 chapter 617, exempted from filing fees, and approved by the 1443 Department of State. 1444 2. Organized and operated to conduct programs and 1445 activities; raise funds; request and receive grants, gifts, and 1446 bequests of money; acquire, receive, hold, and invest, in its 1447 own name, securities, funds, objects of value, or other 1448 property, either real or personal; and make expenditures or 1449 provide funding to or for the direct or indirect benefit of the 1450 department in the furtherance of the prescription drug 1451 monitoring program. 1452 (b) The direct-support organization is not considered a 1453 lobbying firm within the meaning of s. 11.045. 1454 (c) The director of the Office of Drug Control shall 1455 appoint a board of directors for the direct-support 1456 organization. The director may designate employees of the Office 1457 of Drug Control, state employees other than state employees from 1458 the department, and any other nonstate employees as appropriate, 1459 to serve on the board. Members of the board shall serve at the 1460 pleasure of the director of the Office of Drug Control. The 1461 director shall provide guidance to members of the board to 1462 ensure that moneys received by the direct-support organization 1463 are not received from inappropriate sources. Inappropriate 1464 sources include, but are not limited to, donors, grantors, 1465 persons, or organizations that may monetarily or substantively 1466 benefit from the purchase of goods or services by the department 1467 in furtherance of the prescription drug monitoring program. 1468 (d) The direct-support organization shall operate under 1469 written contract with the Office of Drug Control. The contract 1470 must, at a minimum, provide for: 1471 1. Approval of the articles of incorporation and bylaws of 1472 the direct-support organization by the Office of Drug Control. 1473 2. Submission of an annual budget for the approval of the 1474 Office of Drug Control. 1475 3. Certification by the Office of Drug Control in 1476 consultation with the department that the direct-support 1477 organization is complying with the terms of the contract in a 1478 manner consistent with and in furtherance of the goals and 1479 purposes of the prescription drug monitoring program and in the 1480 best interests of the state. Such certification must be made 1481 annually and reported in the official minutes of a meeting of 1482 the direct-support organization. 1483 4. The reversion, without penalty, to the Office of Drug 1484 Control, or to the state if the Office of Drug Control ceases to 1485 exist, of all moneys and property held in trust by the direct 1486 support organization for the benefit of the prescription drug 1487 monitoring program if the direct-support organization ceases to 1488 exist or if the contract is terminated. 1489 5. The fiscal year of the direct-support organization, 1490 which must begin July 1 of each year and end June 30 of the 1491 following year. 1492 6. The disclosure of the material provisions of the 1493 contract to donors of gifts, contributions, or bequests, 1494 including such disclosure on all promotional and fundraising 1495 publications, and an explanation to such donors of the 1496 distinction between the Office of Drug Control and the direct 1497 support organization. 1498 7. The direct-support organization’s collecting, expending, 1499 and providing of funds to the department for the development, 1500 implementation, and operation of the prescription drug 1501 monitoring program as described in this section and s. 2, 1502 chapter 2009-198, Laws of Florida, as long as the task force is 1503 authorized. The direct-support organization may collect and 1504 expend funds to be used for the functions of the direct-support 1505 organization’s board of directors, as necessary and approved by 1506 the director of the Office of Drug Control. In addition, the 1507 direct-support organization may collect and provide funding to 1508 the department in furtherance of the prescription drug 1509 monitoring program by: 1510 a. Establishing and administering the prescription drug 1511 monitoring program’s electronic database, including hardware and 1512 software. 1513 b. Conducting studies on the efficiency and effectiveness 1514 of the program to include feasibility studies as described in 1515 subsection (13). 1516 c. Providing funds for future enhancements of the program 1517 within the intent of this section. 1518 d. Providing user training of the prescription drug 1519 monitoring program, including distribution of materials to 1520 promote public awareness and education and conducting workshops 1521 or other meetings, for health care practitioners, pharmacists, 1522 and others as appropriate. 1523 e. Providing funds for travel expenses. 1524 f. Providing funds for administrative costs, including 1525 personnel, audits, facilities, and equipment. 1526 g. Fulfilling all other requirements necessary to implement 1527 and operate the program as outlined in this section. 1528 (e) The activities of the direct-support organization must 1529 be consistent with the goals and mission of the Office of Drug 1530 Control, as determined by the office in consultation with the 1531 department, and in the best interests of the state. The direct 1532 support organization must obtain a written approval from the 1533 director of the Office of Drug Control for any activities in 1534 support of the prescription drug monitoring program before 1535 undertaking those activities. 1536 (f) The Office of Drug Control, in consultation with the 1537 department, may permit, without charge, appropriate use of 1538 administrative services, property, and facilities of the Office 1539 of Drug Control and the department by the direct-support 1540 organization, subject to this section. The use must be directly 1541 in keeping with the approved purposes of the direct-support 1542 organization and may not be made at times or places that would 1543 unreasonably interfere with opportunities for the public to use 1544 such facilities for established purposes. Any moneys received 1545 from rentals of facilities and properties managed by the Office 1546 of Drug Control and the department may be held by the Office of 1547 Drug Control or in a separate depository account in the name of 1548 the direct-support organization and subject to the provisions of 1549 the letter of agreement with the Office of Drug Control. The 1550 letter of agreement must provide that any funds held in the 1551 separate depository account in the name of the direct-support 1552 organization must revert to the Office of Drug Control if the 1553 direct-support organization is no longer approved by the Office 1554 of Drug Control to operate in the best interests of the state. 1555 (g) The Office of Drug Control, in consultation with the 1556 department, may adopt rules under s. 120.54 to govern the use of 1557 administrative services, property, or facilities of the 1558 department or office by the direct-support organization. 1559 (h) The Office of Drug Control may not permit the use of 1560 any administrative services, property, or facilities of the 1561 state by a direct-support organization if that organization does 1562 not provide equal membership and employment opportunities to all 1563 persons regardless of race, color, religion, gender, age, or 1564 national origin. 1565 (i) The direct-support organization shall provide for an 1566 independent annual financial audit in accordance with s. 1567 215.981. Copies of the audit shall be provided to the Office of 1568 Drug Control and the Office of Policy and Budget in the 1569 Executive Office of the Governor. 1570 (j) The direct-support organization may not exercise any 1571 power under s. 617.0302(12) or (16). 1572 (12) A prescriber or dispenser may have access to the 1573 information under this section which relates to a patient of 1574 that prescriber or dispenser as needed for the purpose of 1575 reviewing the patient’s controlled drug prescription history. A 1576 prescriber or dispenser acting in good faith is immune from any 1577 civil, criminal, or administrative liability that might 1578 otherwise be incurred or imposed for receiving or using 1579 information from the prescription drug monitoring program. This 1580 subsection does not create a private cause of action, and a 1581 person may not recover damages against a prescriber or dispenser 1582 authorized to access information under this subsection for 1583 accessing or failing to access such information. 1584 (13) To the extent that funding is provided for such 1585 purpose through federal or private grants or gifts and other 1586 types of available moneys, the department, in collaboration with 1587 the Office of Drug Control, shall study the feasibility of 1588 enhancing the prescription drug monitoring program for the 1589 purposes of public health initiatives and statistical reporting 1590 that respects the privacy of the patient, the prescriber, and 1591 the dispenser. Such a study shall be conducted in order to 1592 further improve the quality of health care services and safety 1593 by improving the prescribing and dispensing practices for 1594 prescription drugs, taking advantage of advances in technology, 1595 reducing duplicative prescriptions and the overprescribing of 1596 prescription drugs, and reducing drug abuse. The requirements of 1597 the National All Schedules Prescription Electronic Reporting 1598 (NASPER) Act are authorized in order to apply for federal NASPER 1599 funding. In addition, the direct-support organization shall 1600 provide funding for the department, in collaboration with the 1601 Office of Drug Control, to conduct training for health care 1602 practitioners and other appropriate persons in using the 1603 monitoring program to support the program enhancements. 1604 (14) A pharmacist, pharmacy, or dispensing health care 1605 practitioner or his or her agent, before releasing a controlled 1606 substance to any person not known to such dispenser, shall 1607 require the person purchasing, receiving, or otherwise acquiring 1608 the controlled substance to present valid photographic 1609 identification or other verification of his or her identity to 1610 the dispenser. If the person does not have proper 1611 identification, the dispenser may verify the validity of the 1612 prescription and the identity of the patient with the prescriber 1613 or his or her authorized agent. Verification of health plan 1614 eligibility through a real-time inquiry or adjudication system 1615 will be considered to be proper identification. This subsection 1616 does not apply in an institutional setting or to a long-term 1617 care facility, including, but not limited to, an assisted living 1618 facility or a hospital to which patients are admitted. As used 1619 in this subsection, the term “proper identification” means an 1620 identification that is issued by a state or the Federal 1621 Government containing the person’s photograph, printed name, and 1622 signature or a document considered acceptable under 8 C.F.R. s. 1623 274a.2(b)(1)(v)(A) and (B). 1624 (15) The Agency for Health Care Administration shall 1625 continue the promotion of electronic prescribing by health care 1626 practitioners, health care facilities, and pharmacies under s. 1627 408.0611. 1628 (16) By October 1, 2010, the department shall adopt rules 1629 pursuant to ss. 120.536(1) and 120.54 to administer the 1630 provisions of this section, which shall include as necessary the 1631 reporting, accessing, evaluation, management, development, 1632 implementation, operation, and storage of information within the 1633 monitoring program’s system. 1634 (17) After the prescription drug monitoring program’s 1635 database has been operational for 12 months, the State Surgeon 1636 General shall enter into reciprocal agreements for the sharing 1637 of prescription drug monitoring information with any other state 1638 that has a compatible prescription drug monitoring program. If 1639 the State Surgeon General evaluates the prescription drug 1640 monitoring program of another state as authorized in this 1641 subsection, priority shall be given to a state that is 1642 contiguous with the borders of this state. 1643 (a) In determining compatibility, the State Surgeon General 1644 shall consider: 1645 1. The essential purposes of the program and the success of 1646 the program in fulfilling those purposes. 1647 2. The safeguards for privacy of patient records and the 1648 success of the program in protecting patient privacy. 1649 3. The persons authorized to view the data collected by the 1650 program. Comparable organizations and professions for 1651 practitioners in other states, law enforcement agencies, the 1652 Attorney General’s Medicaid Fraud Unit, medical regulatory 1653 boards, and, as needed, management staff who have similar duties 1654 as management staff who work with the prescription drug 1655 monitoring program as authorized in s. 893.0551 are authorized 1656 access upon approval by the State Surgeon General. 1657 4. The schedules of the controlled substances that are 1658 monitored. 1659 5. The data required to be submitted for each prescription. 1660 6. Any implementing criteria deemed essential for a 1661 thorough comparison. 1662 (b) The State Surgeon General shall annually review any 1663 agreement to determine its continued compatibility with the 1664 prescription drug monitoring program in this state. 1665 (c) Any agreement between the State Surgeon General and 1666 another state shall prohibit the sharing of information 1667 concerning a resident of this state or a practitioner, 1668 pharmacist, or other prescriber for any purpose that is not 1669 otherwise authorized by this section or s. 893.0551. 1670 Section 22. Paragraph (a) of subsection (3) of section 1671 893.0551, Florida Statutes, is amended, present subsections (4), 1672 (5), (6), and (7) of that section are redesignated as 1673 subsections (5), (6), (7), and (8), respectively, and a new 1674 subsection (4) is added to that section, to read: 1675 893.0551 Public records exemption for the prescription drug 1676 monitoring program.— 1677 (3) The department shall disclose such confidential and 1678 exempt information to the following entities after using a 1679 verification process to ensure the legitimacy of that person’s 1680 or entity’s request for the information: 1681 (a) The Attorney General and his or her designee when 1682 working on Medicaid fraud cases and Medicaid investigations 1683 involving prescribed controlled substancesprescription drugsor 1684 when the Attorney General has initiated a review of specific 1685 identifiers of Medicaid fraud or specific identifiers that 1686 warrant a Medicaid investigation regarding prescribed controlled 1687 substancesprescription drugs. The Attorney General or his or 1688 her designee may disclose the confidential and exempt 1689 information received from the department to a criminal justice 1690 agency as defined in s. 119.011 as part of an active 1691 investigation that is specific to a violation of prescription 1692 drug abuse or prescription drug diversion law as it relates to 1693 controlled substances. The Attorney General’s Medicaid fraud 1694 investigators and Medicaid investigators may not have direct 1695 access to the department’s database. 1696 (4) The department may disclose confidential and exempt 1697 information contained in records held by the department under s. 1698 893.055 if the State Surgeon General has entered into a 1699 reciprocal agreement for the sharing of prescription drug 1700 monitoring information with any other state that has a 1701 compatible prescription drug monitoring program. 1702 (a) The reciprocal agreement may allow the following 1703 persons from another state to receive information from the 1704 prescription drug monitoring program if approved by the State 1705 Surgeon General: 1706 1. A designated representative of a state professional 1707 licensing, certification, or regulatory agency charged with 1708 oversight of those persons authorized to prescribe or dispense 1709 controlled substances for the purpose of a bona fide, specific 1710 investigation of a prescription of a controlled substance which 1711 involves a designated person. As required in s. 893.055, this 1712 authorization does not preclude the requirement for the program 1713 manager to review the request for information and validate it. 1714 2. A health care practitioner or pharmacist licensed in the 1715 state from which the request originates. Such health care 1716 practitioner or pharmacist shall certify that the requested 1717 information is for the purpose of providing medical or 1718 pharmaceutical treatment to a bona fide, current patient. The 1719 health care practitioner or pharmacist shall follow all the 1720 procedures required in s. 893.055 and rules established by the 1721 department for a health care practitioner or pharmacist to 1722 request information from the database. 1723 3. A law enforcement officer from another state: 1724 a. Who is a member of a sheriff’s department or a police 1725 department; 1726 b. Who is authorized by law to conduct criminal 1727 investigations and make arrests; 1728 c. Whose duty it is to enforce the laws of his or her state 1729 relating to controlled substances; and 1730 d. Who is engaged in a bona fide specific, active 1731 investigation involving a designated person regarding 1732 prescriptions for controlled substances. 1733 1734 As required in s. 893.055, this authorization does not preclude 1735 the requirement for the program manager to review the request 1736 for information and validate it. This authorization also does 1737 not preclude the ability to provide a report to a law 1738 enforcement agency in another state under s. 893.055(7) or this 1739 subsection. 1740 (b) Any agreement between the State Surgeon General and 1741 another state shall prohibit the sharing of information 1742 concerning a resident of this state, a patient whose information 1743 is in the program’s database, or a practitioner, pharmacy, 1744 pharmacist, health care practitioner, or other prescriber for 1745 any purpose that is not otherwise authorized by this section or 1746 s. 893.055, and the information must be provided according to 1747 the State Surgeon General’s determination of compatibility as 1748 described in s. 893.055(17). 1749 Section 23. Subsections (1), (4), and (5) of section 1750 893.07, Florida Statutes, are amended, and subsection (6) is 1751 added to that section, to read: 1752 893.07 Records.— 1753 (1) Notwithstanding any other provision of law and in 1754 consonance with the authority of State v. Carter, 23 So. 3d 798 1755 (Fla. 1st DCA 2009) and State v. Tamulonis, 39 So. 3d 524 (Fla. 1756 2nd DCA 2010), every person who engages in the manufacture, 1757 compounding, mixing, cultivating, growing, or by any other 1758 process producing or preparing, or in the dispensing, 1759 importation, or, as a wholesaler, distribution, of controlled 1760 substances shall: 1761 (a) On January 1, 1974, or as soon thereafter as any person 1762 first engages in such activity, and every second year 1763 thereafter, make a complete and accurate record of all stocks of 1764 controlled substances on hand. The inventory may be prepared on 1765 the regular physical inventory date which is nearest to, and 1766 does not vary by more than 6 months from, the biennial date that 1767 would otherwise apply. As additional substances are designated 1768 for control under this chapter, they shall be inventoried as 1769 provided for in this subsection. 1770 (b) On and after January 1, 1974, maintain, on a current 1771 basis, a complete and accurate record of each substance 1772 manufactured, received, sold, delivered, or otherwise disposed 1773 of by him or her, except that this subsection shall not require 1774 the maintenance of a perpetual inventory. 1775 1776 Compliance with the provisions of federal law pertaining to the 1777 keeping of records of controlled substances shall be deemed a 1778 compliance with the requirements of this subsection. 1779 (4) Every inventory or record required by this chapter, 1780 including prescription records, shall be maintained: 1781 (a) Separately from all other records of the registrant, or 1782 (b) Alternatively, in the case of Schedule III, IV, or V 1783 controlled substances, in such form that information required by 1784 this chapter is readily retrievable from the ordinary business 1785 records of the registrant. 1786 1787 In either case, such records described in this subsection shall 1788 be kept and made available for a period of at least 2 years for 1789 inspection and copying by law enforcement officers whose duty it 1790 is to enforce the laws of this state relating to controlled 1791 substances. This subsection does not require a law enforcement 1792 officer to obtain a subpoena, court order, or search warrant in 1793 order to obtain access to or copies of such records. 1794 (5) Each person shall maintain a record that containswhich1795shall containa detailed list of controlled substances lost, 1796 destroyed, or stolen, if any; the kind and quantity of such 1797 controlled substances; and the date of the discovering of such 1798 loss, destruction, or theft. If a person discovers the theft or 1799 loss of a controlled substance, such person shall report the 1800 theft or loss to a local county sheriff’s office within 48 hours 1801 after the discovery of such theft or loss. A person who fails to 1802 report the theft or loss of a controlled substance under this 1803 subsection commits a misdemeanor of the second degree, 1804 punishable as provided in s. 775.082 or s. 775.083. However, a 1805 person who fails to report the theft or loss of a Schedule II 1806 controlled substance commits a misdemeanor of the first degree, 1807 punishable as provided in s. 775.082 or s. 775.083. 1808 (6) The Legislature finds that the opinions rendered in 1809 State v. Carter, 23 So. 3d 798 (Fla. 1st DCA 2009), and State v. 1810 Tamulonis, 39 So. 3d 524 (Fla. 2nd DCA 2010), correctly construe 1811 this Legislature’s intent that the inspection powers previously 1812 conferred upon law enforcement officers which allow such 1813 officers to access and review pharmacy records concerning 1814 controlled substances are to be exercised properly by such law 1815 enforcement officers without the requirement of a subpoena or 1816 search warrant being sought or issued to examine and copy such 1817 records, and without the requirement that those persons to whom 1818 particular pharmacy records refer be given notice of the 1819 records’ examination and copying under this section. 1820 Section 24. Subsections (7) and (8) of section 893.13, 1821 Florida Statutes, are amended to read: 1822 893.13 Prohibited acts; penalties.— 1823 (7)(a) AIt is unlawful for anyperson may not: 1824 1.ToDistribute or dispense a controlled substance in 1825 violation of this chapter. 1826 2.ToRefuse or fail to make, keep, or furnish any record, 1827 notification, order form, statement, invoice, or information 1828 required under this chapter. 1829 3.ToRefuseanentry into any premises for any inspection 1830 ortorefuse to allow any inspection authorized by this chapter. 1831 4.ToDistribute a controlled substance named or described 1832 in s. 893.03(1) or (2) except pursuant to an order form as 1833 required by s. 893.06. 1834 5.ToKeep or maintain any store, shop, warehouse, 1835 dwelling, building, vehicle, boat, aircraft, or other structure 1836 or place which is resorted to by persons using controlled 1837 substances in violation of this chapter for the purpose of using 1838 these substances, or which is used for keeping or selling them 1839 in violation of this chapter. 1840 6.ToUse to his or her own personal advantage, orto1841 reveal, any information obtained in enforcement of this chapter 1842 except in a prosecution or administrative hearing for a 1843 violation of this chapter. 1844 7.ToPossess a prescription form which has not been 1845 completed and signed by the practitioner whose name appears 1846 printed thereon, unless the person is that practitioner, is an 1847 agent or employee of that practitioner, is a pharmacist, or is a 1848 supplier of prescription forms who is authorized by that 1849 practitioner to possess those forms. 1850 8.ToWithhold information from a practitioner from whom 1851 the person seeks to obtain a controlled substance or a 1852 prescription for a controlled substance that the person making 1853 the request has received a controlled substance or a 1854 prescription for a controlled substance of like therapeutic use 1855 from another practitioner within the previous 30 days. 1856 9.ToAcquire or obtain, or attempt to acquire or obtain, 1857 possession of a controlled substance by misrepresentation, 1858 fraud, forgery, deception, or subterfuge. 1859 10.ToAffix any false or forged label to a package or 1860 receptacle containing a controlled substance. 1861 11.ToFurnish false or fraudulent material information in, 1862 or omit any material information from, any report or other 1863 document required to be kept or filed under this chapter or any 1864 record required to be kept by this chapter. 1865 12.ToStore anhydrous ammonia in a container that is not 1866 approved by the United States Department of Transportation to 1867 hold anhydrous ammonia or is not constructed in accordance with 1868 sound engineering, agricultural, or commercial practices. 1869 13. With the intent to obtain a controlled substance or 1870 combination of controlled substances that are not medically 1871 necessary for the person or an amount of a controlled substance 1872 or substances that are not medically necessary for the person, 1873 obtain or attempt to obtain from a practitioner a controlled 1874 substance or a prescription for a controlled substance by 1875 misrepresentation, fraud, forgery, deception, subterfuge, or 1876 concealment of a material fact. For purposes of this 1877 subparagraph, a material fact includes whether the person has an 1878 existing prescription for a controlled substance issued for the 1879 same period of time by another practitioner or as described in 1880 subparagraph 8. 1881 (b) A health care practitioner, with the intent to provide 1882 a controlled substance or combination of controlled substances 1883 that are not medically necessary to his or her patient or an 1884 amount of controlled substances that are not medically necessary 1885 for his or her patient, may not provide a controlled substance 1886 or a prescription for a controlled substance by 1887 misrepresentation, fraud, forgery, deception, subterfuge, or 1888 concealment of a material fact. For purposes of this paragraph, 1889 a material fact includes whether the patient has an existing 1890 prescription for a controlled substance issued for the same 1891 period of time by another practitioner or as described in 1892 subparagraph (a)8. 1893 (c) Any person who adulterates a controlled substance for 1894 directed off-label use without authorization by a prescribing 1895 physician violates the provisions of subparagraph (a)1. and 1896 causes the issuance of the entire prescription for the 1897 controlled substance to become invalid. A law enforcement 1898 officer in the performance of his or her official duties may 1899 seize the adulterated or off-label prescribed controlled 1900 substance as evidence. The controlled substance may be returned 1901 to the owner only with a notarized affidavit from the original 1902 prescribing practitioner who has knowledge and gave 1903 authorization and explicit directions for the adulteration or 1904 off-label use of the controlled substance. 1905 (d)(b)Any person who violates the provisions of 1906 subparagraphs (a)1.-7. commits a misdemeanor of the first 1907 degree, punishable as provided in s. 775.082 or s. 775.083; 1908 except that, upon a second or subsequent violation, the person 1909 commits a felony of the third degree, punishable as provided in 1910 s. 775.082, s. 775.083, or s. 775.084. 1911 (e)(c)Any person who violates the provisions of 1912 subparagraphs (a)8.-12. commits a felony of the third degree, 1913 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 1914 (f) A person or health care practitioner who violates the 1915 provisions of paragraph (b) or subparagraph (a)13. commits a 1916 felony of the third degree, punishable as provided in s. 1917 775.082, s. 775.083, or s. 775.084, if any controlled substance 1918 that is the subject of the offense is listed in Schedule II, 1919 Schedule III, or Schedule IV. 1920 (8)(a) Notwithstanding subsection (9), a prescribing 1921 practitioner may not: 1922 1. Knowingly assist a patient, other person, or the owner 1923 of an animal in obtaining a controlled substance through 1924 deceptive, untrue, or fraudulent representations in or related 1925 to the practice of the prescribing practitioner’s professional 1926 practice; 1927 2. Employ a trick or scheme in the practice of the 1928 prescribing practitioner’s professional practice to assist a 1929 patient, other person, or the owner of an animal in obtaining a 1930 controlled substance; 1931 3. Knowingly write a prescription for a controlled 1932 substance for a fictitious person;or1933 4. Write a prescription for a controlled substance for a 1934 patient, other person, or an animal if the sole purpose of 1935 writing such prescription is to provide a monetary benefit to, 1936 or obtain a monetary benefit for, the prescribing practitioner; 1937 or.1938 5. Write a prescription for a controlled substance for a 1939 patient, other person, or an animal and authorize or direct the 1940 adulteration of the dispensed form of the controlled substance 1941 for the purpose of ingestion by means of inhalation, injection, 1942 or any other means not medically necessary for the treatment of 1943 the patient. 1944 (b) If the prescribing practitioner wrote a prescription or 1945 multiple prescriptions for a controlled substance for the 1946 patient, other person, or animal for which there was no medical 1947 necessity, or which was in excess of what was medically 1948 necessary to treat the patient, other person, or animal, that 1949 fact does not give rise to any presumption that the prescribing 1950 practitioner violated subparagraph (a)1., but may be considered 1951 with other competent evidence in determining whether the 1952 prescribing practitioner knowingly assisted a patient, other 1953 person, or the owner of an animal to obtain a controlled 1954 substance in violation of subparagraph (a)1. 1955 (c) A person who violates paragraph (a) commits a felony of 1956 the third degree, punishable as provided in s. 775.082, s. 1957 775.083, or s. 775.084. 1958 (d) Notwithstanding paragraph (c), if a prescribing 1959 practitioner has violated paragraph (a) and received $1,000 or 1960 more in payment for writing one or more prescriptions or, in the 1961 case of a prescription written for a controlled substance 1962 described in s. 893.135, has written one or more prescriptions 1963 for a quantity of a controlled substance which, individually or 1964 in the aggregate, meets the threshold for the offense of 1965 trafficking in a controlled substance under s. 893.15, the 1966 violation is reclassified as a felony of the second degree and 1967 ranked in level 4 of the Criminal Punishment Code. 1968 Section 25. Present subsections (3) through (10) of section 1969 893.138, Florida Statutes, are redesignated as subsections (4) 1970 through (11), respectively, and a new subsection (3) is added to 1971 that section, to read: 1972 893.138 Local administrative action to abate drug-related, 1973 prostitution-related, or stolen-property-related public 1974 nuisances and criminal gang activity.— 1975 (3) Any pain-management clinic, as described in s. 458.3265 1976 or s. 459.0137, which has been used on more than two occasions 1977 within a 6-month period as the site of a violation of: 1978 (a) Section 784.011, s. 784.021, s. 784.03, or s. 784.045, 1979 relating to assault and battery; 1980 (b) Section 810.02, relating to burglary; 1981 (c) Section 812.014, relating to dealing in theft; 1982 (d) Section 812.131, relating to robbery by sudden 1983 snatching; or 1984 (e) Section 893.13, relating to the unlawful distribution 1985 of controlled substances, 1986 1987 may be declared to be a public nuisance, and such nuisance may 1988 be abated pursuant to the procedures provided in this section. 1989 Section 26. (1) DEFINITIONS.—As used in this section, the 1990 term: 1991 (a) “Interchange or substitution of an opioid analgesic 1992 drug” means the substitution of any opioid analgesic drug, brand 1993 or generic, for the opioid analgesic drug incorporating a 1994 tamper-resistance technology originally prescribed, irrespective 1995 of whether the substituted drug is rated as pharmaceutically and 1996 therapeutically equivalent by the United States Food and Drug 1997 Administration or the Board of Pharmacy or whether the opioid 1998 analgesic drug with tamper-resistance technology bears a 1999 labeling claim with respect to reduction of tampering, abuse, or 2000 abuse potential. 2001 (b) “Opioid analgesic drug” means a drug in the opioid 2002 analgesic drug class prescribed to treat moderate to severe pain 2003 or other conditions, whether in immediate release or extended 2004 release form and whether or not combined with other drug 2005 substances to form a single tablet or other dosage form. 2006 (c) “Opioid analgesic drug incorporating a tamper 2007 resistance technology” means an opioid analgesic drug listed as 2008 such by the Board of Pharmacy based on a submission of evidence 2009 by the drug manufacturer or distributor that the drug: 2010 1. Incorporates a tamper-resistance technology; and 2011 2. Has been approved by the United States Food and Drug 2012 Administration pursuant to an application that includes at least 2013 one study on human tampering or abuse potential or a laboratory 2014 study comparing the tamper- or abuse-resistance properties of 2015 the drug to one or more opioid analgesic drugs that: 2016 a. Have been approved by the United States Food and Drug 2017 Administration; and 2018 b. Serve as a positive control. 2019 (d) “Pharmacist” means any person licensed under chapter 2020 465, Florida Statutes, to practice the profession of pharmacy, 2021 including, but not limited to, a community pharmacist and a 2022 pharmacist in a hospital-based pharmacy, when filling 2023 prescriptions for inpatient or outpatient care. 2024 (2) LIST OF OPIOID ANALGESIC DRUGS INCORPORATING A TAMPER 2025 RESISTANCE TECHNOLOGY.—The Board of Pharmacy shall create a list 2026 of opioid analgesic drugs for which information has been 2027 submitted consistent with paragraph (1)(c). Inclusion of a drug 2028 on such list does not require that the drug bear a labeling 2029 claim with respect to reduction of tampering, abuse, or abuse 2030 potential at the time of listing. Such list must also include a 2031 determination by the Board of Pharmacy as to which listed opioid 2032 analgesic drugs incorporating tamper-resistance technologies 2033 provide substantially similar tamper-resistance properties, 2034 based solely on studies submitted by the drug manufacturer 2035 consistent with paragraph (1)(c). 2036 Section 27. This act shall take effect October 1, 2011.