Bill Text: FL S1386 | 2011 | Regular Session | Comm Sub
Bill Title: Controlled Substances
Spectrum: Bipartisan Bill
Status: (Introduced - Dead) 2011-05-07 - Indefinitely postponed and withdrawn from consideration [S1386 Detail]
Download: Florida-2011-S1386-Comm_Sub.html
Florida Senate - 2011 CS for SB 1386 By the Committee on Health Regulation; and Senator Bogdanoff 588-03249-11 20111386c1 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” for purposes of the 5 Health Care Clinic Act; amending s. 456.037, F.S.; 6 conforming provisions to changes made by the act; 7 amending s. 456.057, F.S.; authorizing the Department 8 of Health to obtain patient records pursuant to a 9 subpoena and without notification to the patient from 10 a controlled-substance medical clinic under certain 11 circumstances; amending s. 458.3265, F.S.; renaming 12 pain-management clinics as “controlled-substance 13 medical clinics”; prohibiting controlled-substance 14 medical clinics from advertising services related to 15 the dispensing of medication; revising the criteria 16 requiring registration with the department as a 17 controlled-substance medical clinic; conforming 18 provisions to changes made by the act; revising the 19 circumstances in which the department may revoke the 20 certificate of registration for a controlled-substance 21 medical clinic; providing an exception for revoking 22 and suspending a certificate of registration for a 23 controlled-substance medical clinic; revising the 24 responsibilities of a physician who provides 25 professional services in a controlled-substance 26 medical clinic; deleting the requirement that the 27 Board of Medicine adopt a rule establishing the 28 maximum number of prescriptions that can be written 29 for certain controlled substances within a specified 30 time; revising the rules setting forth the standards 31 of practice that the board is required to adopt; 32 deleting the provision that describes when a physician 33 is primarily engaged in the treatment of pain; 34 amending s. 458.327, F.S.; conforming provisions to 35 changes made by the act; amending s. 458.331, F.S.; 36 conforming provisions to changes made by the act; 37 revising the acts that constitute grounds for 38 disciplinary action for a licensee who serves as a 39 designated physician of a controlled-substance medical 40 clinic; amending s. 459.0137, F.S.; renaming pain 41 management clinics as “controlled-substance medical 42 clinics”; prohibiting controlled-substance medical 43 clinics from advertising services related to the 44 dispensing of medication; revising the criteria 45 requiring registration with the department as a 46 controlled-substance medical clinic; conforming 47 provisions to changes made by the act; revising the 48 circumstances in which the department may revoke the 49 certificate of registration for a controlled-substance 50 medical clinic; providing an exception for revoking 51 and suspending a certificate of registration for a 52 controlled-substance medical clinic; revising the 53 responsibilities of an osteopathic physician who 54 provides professional services in a controlled 55 substance medical clinic; deleting the requirement 56 that the Board of Osteopathic Medicine adopt a rule 57 establishing the maximum number of prescriptions that 58 can be written for certain controlled substances 59 within a specified time; revising the rules setting 60 forth the standards of practice that the board is 61 required to adopt; deleting the provision that 62 describes when an osteopathic physician is primarily 63 engaged in the treatment of pain; amending s. 459.015, 64 F.S.; conforming provisions to changes made by the 65 act; revising the acts that constitute grounds for 66 disciplinary action for a licensee who serves as a 67 designated osteopathic physician of a controlled 68 substance medical clinic; amending s. 465.0276, F.S.; 69 deleting the provision that prohibits a dispensing 70 practitioner from dispensing a specified amount of a 71 controlled substance under certain circumstances; 72 amending s. 893.055, F.S.; redefining the term 73 “patient advisory report” as it relates to the 74 prescription drug monitoring program; revising the 75 date by which the department is required to establish 76 a comprehensive electronic database system; revising 77 the responsibilities of the dispenser and the 78 prescriber with regard to the electronic database 79 system; revising the circumstances in which the 80 department is required to adopt rules regarding 81 reporting, accessing the database, evaluation, 82 management, development, implementation, operation, 83 security, and storage of information within the 84 electronic database system; deleting the Office of 85 Drug Control as one of the organizations that the 86 department is required to work with in developing 87 rules for the prescription drug monitoring program; 88 requiring that a dispensed controlled substance be 89 reported to the department within a specified number 90 of hours; authorizing law enforcement agencies to 91 request certain confidential and exempt information 92 from the electronic database system upon determination 93 that probable cause exists that a crime is being 94 committed and issuance of a search warrant; providing 95 that all costs incurred by the department in 96 administering the prescription drug monitoring program 97 be funded through federal grants, dispensing 98 registration fees, or private funding applied for or 99 received by the state; requiring the department rather 100 than the Office of Drug Control to establish a direct 101 support organization; requiring the State Surgeon 102 General to appoint the board of directors for the 103 direct-support organization; requiring the direct 104 support organization to operate under written contract 105 with the department; revising requirements for the 106 contract; requiring the activities of the direct 107 support organization to be consistent with the goals 108 and mission of the department; authorizing the 109 department to permit use of certain services, 110 property, and facilities of the department by the 111 direct-support organization; prohibiting the 112 department from permitting the use of any 113 administrative services, property, or facilities of 114 the state by the direct-support organization under 115 certain conditions; requiring the department rather 116 than the Office of Drug Control to study the 117 feasibility of enhancing the prescription drug 118 monitoring program for specified purposes; requiring 119 the direct-support organization to provide funding for 120 the department rather than the Office of Drug Control 121 to conduct training in using the prescription drug 122 monitoring program; revising the date in which the 123 department must adopt rules; amending s. 893.0551, 124 F.S.; authorizing a law enforcement agency to disclose 125 certain confidential and exempt information received 126 from the department to a criminal justice agency 127 pursuant to a search warrant; providing an effective 128 date. 129 130 Be It Enacted by the Legislature of the State of Florida: 131 132 Section 1. Subsections (4) and (7) of section 400.9905, 133 Florida Statutes, are amended to read: 134 400.9905 Definitions.— 135 (4) “Clinic” means an entity at which health care services 136 are provided to individuals and which tenders charges for 137 reimbursement or payment for such services, including a mobile 138 clinic and a portable equipment provider. For purposes of this 139 part, the term does not include and the licensure requirements 140 of this part do not apply to: 141 (a) Entities licensed or registered by the state under 142 chapter 395; or entities licensed or registered by the state and 143 providing only health care services within the scope of services 144 authorized under their respective licenses granted under ss. 145 383.30-383.335, chapter 390, chapter 394, chapter 397, this 146 chapter except part X, chapter 429, chapter 463, chapter 465, 147 chapter 466, chapter 478, part I of chapter 483, chapter 484, or 148 chapter 651; end-stage renal disease providers authorized under 149 42 C.F.R. part 405, subpart U; or providers certified under 42 150 C.F.R. part 485, subpart B or subpart H; or any entity that 151 provides neonatal or pediatric hospital-based health care 152 services or other health care services by licensed practitioners 153 solely within a hospital licensed under chapter 395. 154 (b) Entities that own, directly or indirectly, entities 155 licensed or registered by the state pursuant to chapter 395; or 156 entities that own, directly or indirectly, entities licensed or 157 registered by the state and providing only health care services 158 within the scope of services authorized pursuant to their 159 respective licenses granted under ss. 383.30-383.335, chapter 160 390, chapter 394, chapter 397, this chapter except part X, 161 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, 162 part I of chapter 483, chapter 484, chapter 651; end-stage renal 163 disease providers authorized under 42 C.F.R. part 405, subpart 164 U; or providers certified under 42 C.F.R. part 485, subpart B or 165 subpart H; or any entity that provides neonatal or pediatric 166 hospital-based health care services by licensed practitioners 167 solely within a hospital licensed under chapter 395. 168 (c) Entities that are owned, directly or indirectly, by an 169 entity licensed or registered by the state pursuant to chapter 170 395; or entities that are owned, directly or indirectly, by an 171 entity licensed or registered by the state and providing only 172 health care services within the scope of services authorized 173 pursuant to their respective licenses granted under ss. 383.30 174 383.335, chapter 390, chapter 394, chapter 397, this chapter 175 except part X, chapter 429, chapter 463, chapter 465, chapter 176 466, chapter 478, part I of chapter 483, chapter 484, or chapter 177 651; end-stage renal disease providers authorized under 42 178 C.F.R. part 405, subpart U; or providers certified under 42 179 C.F.R. part 485, subpart B or subpart H; or any entity that 180 provides neonatal or pediatric hospital-based health care 181 services by licensed practitioners solely within a hospital 182 under chapter 395. 183 (d) Entities that are under common ownership, directly or 184 indirectly, with an entity licensed or registered by the state 185 pursuant to chapter 395; or entities that are under common 186 ownership, directly or indirectly, with an entity licensed or 187 registered by the state and providing only health care services 188 within the scope of services authorized pursuant to their 189 respective licenses granted under ss. 383.30-383.335, chapter 190 390, chapter 394, chapter 397, this chapter except part X, 191 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, 192 part I of chapter 483, chapter 484, or chapter 651; end-stage 193 renal disease providers authorized under 42 C.F.R. part 405, 194 subpart U; or providers certified under 42 C.F.R. part 485, 195 subpart B or subpart H; or any entity that provides neonatal or 196 pediatric hospital-based health care services by licensed 197 practitioners solely within a hospital licensed under chapter 198 395. 199 (e) An entity that is exempt from federal taxation under 26 200 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan 201 under 26 U.S.C. s. 409 that has a board of trustees not less 202 than two-thirds of which are Florida-licensed health care 203 practitioners and provides only physical therapy services under 204 physician orders, any community college or university clinic, 205 and any entity owned or operated by the federal or state 206 government, including agencies, subdivisions, or municipalities 207 thereof. 208 (f) A sole proprietorship, group practice, partnership, or 209 corporation that provides health care services by physicians 210 covered by s. 627.419, that is directly supervised by one or 211 more of such physicians, and that is wholly owned by one or more 212 of those physicians or by a physician and the spouse, parent, 213 child, or sibling of that physician. 214 (g) A sole proprietorship, group practice, partnership, or 215 corporation that provides health care services by licensed 216 health care practitioners under chapter 457, chapter 458, 217 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, 218 chapter 466, chapter 467, chapter 480, chapter 484, chapter 486, 219 chapter 490, chapter 491, or part I, part III, part X, part 220 XIII, or part XIV of chapter 468, or s. 464.012, which are 221 wholly owned by one or more licensed health care practitioners, 222 or the licensed health care practitioners set forth in this 223 paragraph and the spouse, parent, child, or sibling of a 224 licensed health care practitioner, so long as one of the owners 225 who is a licensed health care practitioner is supervising the 226 business activities and is legally responsible for the entity’s 227 compliance with all federal and state laws. However, a health 228 care practitioner may not supervise services beyond the scope of 229 the practitioner’s license, except that, for the purposes of 230 this part, a clinic owned by a licensee in s. 456.053(3)(b) that 231 provides only services authorized pursuant to s. 456.053(3)(b) 232 may be supervised by a licensee specified in s. 456.053(3)(b). 233 (h) Clinical facilities affiliated with an accredited 234 medical school at which training is provided for medical 235 students, residents, or fellows. 236 (i) Entities that provide only oncology or radiation 237 therapy services by physicians licensed under chapter 458 or 238 chapter 459 or entities that provide oncology or radiation 239 therapy services by physicians licensed under chapter 458 or 240 chapter 459 which are owned by a corporation whose shares are 241 publicly traded on a recognized stock exchange. 242 (j) Clinical facilities affiliated with a college of 243 chiropractic accredited by the Council on Chiropractic Education 244 at which training is provided for chiropractic students. 245 (k) Entities that provide licensed practitioners to staff 246 emergency departments or to deliver anesthesia services in 247 facilities licensed under chapter 395 and that derive at least 248 90 percent of their gross annual revenues from the provision of 249 such services. Entities claiming an exemption from licensure 250 under this paragraph must provide documentation demonstrating 251 compliance. 252 (l) Orthotic or prosthetic clinical facilities that are a 253 publicly traded corporation or that are wholly owned, directly 254 or indirectly, by a publicly traded corporation. As used in this 255 paragraph, a publicly traded corporation is a corporation that 256 issues securities traded on an exchange registered with the 257 United States Securities and Exchange Commission as a national 258 securities exchange. 259 (7) “Portable equipment provider” means an entity that 260 contracts with or employs persons to provide portable equipment 261 to multiple locations performing treatment or diagnostic testing 262 of individuals,that bills third-party payors for those263services,and that otherwise meets the definition of a clinic in 264 subsection (4). 265 Section 2. Subsection (5) of section 456.037, Florida 266 Statutes, is amended to read: 267 456.037 Business establishments; requirements for active 268 status licenses; delinquency; discipline; applicability.— 269 (5) This section applies to any business establishment 270 registered, permitted, or licensed by the department to do 271 business. Business establishments include, but are not limited 272 to, dental laboratories, electrology facilities, massage 273 establishments, pharmacies, and controlled-substance medical 274pain-managementclinics required to be registered under s. 275 458.3265 or s. 459.0137. 276 Section 3. Paragraph (a) of subsection (9) of section 277 456.057, Florida Statutes, is amended to read: 278 456.057 Ownership and control of patient records; report or 279 copies of records to be furnished.— 280 (9)(a)1. The department may obtain patient records pursuant 281 to a subpoena without written authorization from the patient if 282 the department and the probable cause panel of the appropriate 283 board, if any, find reasonable cause to believe that a health 284 care practitioner has excessively or inappropriately prescribed 285 any controlled substance specified in chapter 893 in violation 286 of this chapter or any professional practice act or that a 287 health care practitioner has practiced his or her profession 288 below that level of care, skill, and treatment required as 289 defined by this chapter or any professional practice act and 290 also find that appropriate, reasonable attempts were made to 291 obtain a patient release. Notwithstanding the foregoing, the 292 department need not attempt to obtain a patient release when 293 investigating an offense involving the inappropriate 294 prescribing, overprescribing, or diversion of controlled 295 substances and the offense involves a controlled-substance 296 medicalpain-managementclinic. The department may obtain 297 patient records pursuant to a subpoena and without patient 298 authorization or notification to the patientsubpoenafrom any 299 controlled-substance medicalpain-managementclinic required to 300 be licensed if the department has probable cause to believe that 301 a violation of any provision of s. 458.3265 or s. 459.0137 is 302 occurring or has occurred and reasonably believes that obtaining 303 such patient authorization is not feasible due to the volume of 304 the dispensing and prescribing activity involving controlled 305 substances and that obtaining patient authorizationor the306issuance of a subpoenawould jeopardize the investigation. 307 2. The department may obtain patient records and insurance 308 information pursuant to a subpoena without written authorization 309 from the patient if the department and the probable cause panel 310 of the appropriate board, if any, find reasonable cause to 311 believe that a health care practitioner has provided inadequate 312 medical care based on termination of insurance and also find 313 that appropriate, reasonable attempts were made to obtain a 314 patient release. 315 3. The department may obtain patient records, billing 316 records, insurance information, provider contracts, and all 317 attachments thereto pursuant to a subpoena without written 318 authorization from the patient if the department and probable 319 cause panel of the appropriate board, if any, find reasonable 320 cause to believe that a health care practitioner has submitted a 321 claim, statement, or bill using a billing code that would result 322 in payment greater in amount than would be paid using a billing 323 code that accurately describes the services performed, requested 324 payment for services that were not performed by that health care 325 practitioner, used information derived from a written report of 326 an automobile accident generated pursuant to chapter 316 to 327 solicit or obtain patients personally or through an agent 328 regardless of whether the information is derived directly from 329 the report or a summary of that report or from another person, 330 solicited patients fraudulently, received a kickback as defined 331 in s. 456.054, violated the patient brokering provisions of s. 332 817.505, or presented or caused to be presented a false or 333 fraudulent insurance claim within the meaning of s. 334 817.234(1)(a), and also find that, within the meaning of s. 335 817.234(1)(a), patient authorization cannot be obtained because 336 the patient cannot be located or is deceased, incapacitated, or 337 suspected of being a participant in the fraud or scheme, and if 338 the subpoena is issued for specific and relevant records. 339 4. Notwithstanding subparagraphs 1.-3., when the department 340 investigates a professional liability claim or undertakes action 341 pursuant to s. 456.049 or s. 627.912, the department may obtain 342 patient records pursuant to a subpoena without written 343 authorization from the patient if the patient refuses to 344 cooperate or if the department attempts to obtain a patient 345 release and the failure to obtain the patient records would be 346 detrimental to the investigation. 347 Section 4. Section 458.3265, Florida Statutes, is amended 348 to read: 349 458.3265 Controlled-substance medicalpain-management350 clinics.— 351 (1) REGISTRATION.— 352 (a) AAllprivately owned controlled-substance medical 353 clinic, facility, or officepain-management clinics, facilities,354or offices, hereinafter referred to as a “clinic,”“clinics,”355 may not advertise services related to the dispensing of 356 medication. A controlled-substance medical clinic is a facility 357 that employs a physician who prescribes on any given day more 358 than 25 prescriptions of Schedule II or Schedule III controlled 359 substance medications, or a combination thereof,which advertise360in any medium for any type of pain-management services,or 361 employsemploya physician who isprimarilyengaged inthe362treatment of pain by prescribing ordispensing controlled 363 substance medications. Such a clinic,must register with the 364 department unless: 365 1. That clinic is licensed as a facility pursuant to 366 chapter 395; 367 2. The majority of the physicians who provide services in 368 the clinic primarily provide interventional pain-management 369 procedures or other surgical services; 370 3. The clinic is owned by a publicly held corporation whose 371 shares are traded on a national exchange or on the over-the 372 counter market and whose total assets at the end of the 373 corporation’s most recent fiscal quarter exceeded $50 million; 374 4. The clinic is affiliated with an accredited medical 375 school at which training is provided for medical students, 376 residents, or fellows; or 3775. The clinic does not prescribe or dispense controlled378substances for the treatment of pain; or379 5.6.The clinic is owned by a corporate entity exempt from 380 federal taxation under 26 U.S.C. s. 501(c)(3). 381 (b) Each clinic location shall be registered separately 382 regardless of whether the clinic is operated under the same 383 business name or management as another clinic. 384 (c) As a part of registration, a clinic must designate a 385 physician who is responsible for complying with all requirements 386 related to registration and operation of the clinic in 387 compliance with this section. Within 10 days after termination 388 of a designated physician, the clinic must notify the department 389 of the identity of another designated physician for that clinic. 390 The designated physician shall have a full, active, and 391 unencumbered license under this chapter or chapter 459 and shall 392 practice at the clinic location for which the physician has 393 assumed responsibility. Failing to have a licensed designated 394 physician practicing at the location of the registered clinic 395 may be the basis for a summary suspension of the clinic 396 registration certificate as described in s. 456.073(8) for a 397 license or s. 120.60(6). 398 (d) The department shall deny registration to any clinic 399 that is not fully owned by a physician licensed under this 400 chapter or chapter 459 or a group of physicians, each of whom is 401 licensed under this chapter or chapter 459; or that is not a 402 health care clinic licensed under part X of chapter 400. 403 (e) The department shall deny registration to any 404 controlled-substance medicalpain-managementclinic owned by or 405 with any contractual or employment relationship with a 406 physician: 407 1. Whose Drug Enforcement Administration number has ever 408 been revoked. 409 2. Whose application for a license to prescribe, dispense, 410 or administer a controlled substance has been denied by any 411 jurisdiction. 412 3. Who has been convicted of or pleaded guilty or nolo 413 contendere to, regardless of adjudication, an offense that 414 constitutes a felony for receipt of illicit and diverted drugs, 415 including a controlled substance listed in Schedule I, Schedule 416 II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in 417 this state, any other state, or the United States. 418 (f) If the department finds probable cause that a 419 controlled-substance medicalpain-managementclinic does not 420 meet the requirement of paragraph (d) or is owned, directly or 421 indirectly, by a person meeting any criteria listed in paragraph 422 (e), the department shall revoke the certificate of registration 423 previously issued by the department. As determined by rule, the 424 department may grant an exemption to denying a registration or 425 revoking a previously issued registration if more than 10 years 426 have elapsed since adjudication. As used in this subsection, the 427 term “convicted” includes an adjudication of guilt following a 428 plea of guilty or nolo contendere or the forfeiture of a bond 429 when charged with a crime. 430 (g) The department may revoke the clinic’s certificate of 431 registration and prohibit all physicians associated with that 432 controlled-substance medicalpain-managementclinic from 433 practicing at that clinic location based upon an annual 434 inspection and evaluation of the factors described in subsection 435 (3) and upon a final determination by the probable cause panel 436 of the appropriate board that any physician associated with that 437 controlled-substance medical clinic knew or should have known of 438 any violations of the factors described in subsection (3). 439 (h)1. If the registration of a controlled-substance medical 440pain-managementclinic is revoked or suspended, the designated 441 physician of the controlled-substance medicalpain-management442 clinic, the owner or lessor of the controlled-substance medical 443pain-managementclinic property, the manager, and the proprietor 444 shall cease to operate the facility as a controlled-substance 445 medicalpain-managementclinic as of the effective date of the 446 suspension or revocation. 447 2. Notwithstanding subparagraph 1., the clinic’s 448 registration shall not be revoked or suspended if the clinic, 449 within 24 hours after notification of suspension or revocation, 450 appoints another designated physician who has a full, active, 451 and unencumbered license under this chapter or chapter 459 to 452 operate a controlled-substance medical clinic. 453 (i) If a controlled-substance medicalpain-management454 clinic registration is revoked or suspended, the designated 455 physician of the controlled-substance medicalpain-management456 clinic, the owner or lessor of the clinic property, the manager, 457 or the proprietor is responsible for removing all signs and 458 symbols identifying the premises as a controlled-substance 459 medicalpain-managementclinic. 460 (j) Upon the effective date of the suspension or 461 revocation, the designated physician of the controlled-substance 462 medicalpain-managementclinic shall advise the department of 463 the disposition of the medicinal drugs located on the premises. 464 The disposition is subject to the supervision and approval of 465 the department. Medicinal drugs that are purchased or held by a 466 controlled-substance medicalpain-managementclinic that is not 467 registered may be deemed adulterated pursuant to s. 499.006. 468 (k) If the clinic’s registration is revoked, any person 469 named in the registration documents of the controlled-substance 470 medicalpain-managementclinic, including persons owning or 471 operating the controlled-substance medicalpain-management472 clinic, may not, as an individual or as a part of a group, apply 473 to operate a controlled-substance medicalpain-managementclinic 474 for 5 years after the date the registration is revoked upon a 475 finding of probable cause, and an opportunity to be heard, that 476 the persons operating such clinic knew or should have known of 477 the violations causing such revocation. 478 (l) The period of suspension for the registration of a 479 controlled-substance medicalpain-managementclinic shall be 480 prescribed by the department, but may not exceed 1 year. 481 (m) A change of ownership of a registered controlled 482 substance medicalpain-managementclinic requires submission of 483 a new registration application. 484 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities 485 apply to any physician who provides professional services in a 486 controlled-substance medicalpain-managementclinic that is 487 required to be registered in subsection (1). 488 (a) A physician may not practice medicine in a controlled 489 substance medicalpain-managementclinic, as described in 490 subsection (4), if:4911.the controlled-substance medicalpain-managementclinic 492 is not registered with the department as required by this 493 section.; or4942. Effective July 1, 2012, the physician has not495successfully completed a pain-medicine fellowship that is496accredited by the Accreditation Council for Graduate Medical497Education or a pain-medicine residency that is accredited by the498Accreditation Council for Graduate Medical Education or, prior499to July 1, 2012, does not comply with rules adopted by the500board.501 502Any physician who qualifies to practice medicine in a pain503management clinic pursuant to rules adopted by the Board of504Medicine as of July 1, 2012, may continue to practice medicine505in a pain-management clinic as long as the physician continues506to meet the qualifications set forth in the board rules. A507physician who violates this paragraph is subject to disciplinary508action by his or her appropriate medical regulatory board.509 (b) A person may not dispense any medication, including a 510 controlled substance, on the premises of a registered 511 controlled-substance medicalpain-managementclinic unless he or 512 she is a physician licensed under this chapter or chapter 459. 513 (c) A physician, advanced registered nurse practitioner, or 514 a physician assistant must perform an appropriate medicala515physicalexamination of a patient on the same day that the 516 physicianhe or shedispenses or prescribes a controlled 517 substance to a patient at a controlled-substance medicalpain518managementclinic. AIf thephysician may not dispense 519prescribes ordispensesmore than a 30-day supply72-hour dose520 of controlled substances to any patientfor the treatment of521chronic nonmalignant pain, the physician must document in the522patient’s record the reason for prescribing or dispensing that523quantity. 524 (d) A physician authorized to prescribe controlled 525 substances who practices at a controlled-substance medicalpain526managementclinic is responsible for maintaining the control and 527 security of his or her prescription blanks and any other method 528 used for prescribing controlled substance pain medication. The 529 physician shall comply with the requirements for counterfeit 530 resistant prescription blanks in s. 893.065 and the rules 531 adopted pursuant to that section. The physician shall notify, in 532 writing, the department within 24 hours after discovering 533followingany theft or loss of a prescription blank or breach of 534 any other method for prescribing controlled substancespain535medication. 536 (e) The designated physician of a controlled-substance 537 medicalpain-managementclinic shall notify the applicable board 538 in writing of the date of termination of employment within 10 539 days after terminating his or her employment with a controlled 540 substance medicalpain-managementclinic that is required to be 541 registered under subsection (1). 542 (3) INSPECTION.— 543 (a) The department shall inspect the controlled-substance 544 medicalpain-managementclinic annually, including a review of 545 the patient records, to ensure that it complies with this 546 section and the rules of the Board of Medicine adopted pursuant 547 to subsection (4) unless the clinic is accredited by a 548 nationally recognized accrediting agency approved by the Board 549 of Medicine. 550 (b) During an onsite inspection, the department shall make 551 a reasonable attempt to discuss each violation with the owner or 552 designated physician of the controlled-substance medicalpain553managementclinic before issuing a formal written notification. 554 (c) Any action taken to correct a violation shall be 555 documented in writing by the owner or designated physician of 556 the controlled-substance medicalpain-managementclinic and 557 verified by followup visits by departmental personnel. 558 (4) RULEMAKING.— 559 (a) The department shall adopt rules necessary to 560 administer the registration and inspection of controlled 561 substance medicalpain-managementclinics which establish the 562 specific requirements, procedures, forms, and fees. 563 (b) The department shall adopt a rule defining what 564 constitutes practice by a designated physician at the clinic 565 location for which the physician has assumed responsibility, as 566 set forth in subsection (1). When adopting the rule, the 567 department shall consider the number of clinic employees, the 568 location of the controlled-substance medicalpain-management569 clinic, the clinic’s hours of operation, and the amount of 570 controlled substances being prescribed, dispensed, or 571 administered at the controlled-substance medicalpain-management572 clinic. 573(c) The Board of Medicine shall adopt a rule establishing574the maximum number of prescriptions for Schedule II or Schedule575III controlled substances or the controlled substance Alprazolam576which may be written at any one registered pain-management577clinic during any 24-hour period.578 (c)(d)The Board of Medicine shall adopt rules setting 579 forth standards of practice for physicians practicing in 580 privately owned controlled-substance medicalpain-management581 clinics that primarily engage in the treatment of pain by 582 prescribing or dispensing controlled substance medications. Such 583 rules shall address, but need not be limited to: 584 1. Facility operations; 585 2. Physical operations; 586 3. Infection control requirements; 587 4. Health and safety requirements; 588 5. Quality assurance requirements; 589 6. Patient records; 5907. Training requirements for all facility health care591practitioners who are not regulated by another board;592 7.8.Inspections; and 593 8.9.Data collection and reporting requirements. 594 595A physician is primarily engaged in the treatment of pain by596prescribing or dispensing controlled substance medications when597the majority of the patients seen are prescribed or dispensed598controlled substance medications for the treatment of chronic599nonmalignant pain. Chronic nonmalignant pain is pain unrelated600to cancer which persists beyond the usual course of the disease601or the injury that is the cause of the pain or more than 90 days602after surgery.603 (5) PENALTIES; ENFORCEMENT.— 604 (a) The department may impose an administrative fine on the 605 clinic of up to $5,000 per violation for violating the 606 requirements of this section; chapter 499, the Florida Drug and 607 Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and 608 Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug 609 Abuse Prevention and Control Act; chapter 893, the Florida 610 Comprehensive Drug Abuse Prevention and Control Act; or the 611 rules of the department. In determining whether a penalty is to 612 be imposed, and in fixing the amount of the fine, the department 613 shall consider the following factors: 614 1. The gravity of the violation, including the probability 615 that death or serious physical or emotional harm to a patient 616 has resulted, or could have resulted, from the controlled 617 substance medicalpain-managementclinic’s actions or the 618 actions of the physician, the severity of the action or 619 potential harm, and the extent to which the provisions of the 620 applicable laws or rules were violated. 621 2. What actions, if any, the owner or designated physician 622 took to correct the violations. 623 3. Whether there were any previous violations at the 624 controlled-substance medicalpain-managementclinic. 625 4. The financial benefits that the controlled-substance 626 medicalpain-managementclinic derived from committing or 627 continuing to commit the violation. 628 (b) Each day a violation continues after the date fixed for 629 termination of the violation as ordered by the department 630 constitutes an additional, separate, and distinct violation. 631 (c) The department may impose a fine and, in the case of an 632 owner-operated controlled-substance medicalpain-management633 clinic, revoke or deny a controlled-substance medicalpain634managementclinic’s registration, if the clinic’s designated 635 physician knowingly and intentionally misrepresents actions 636 taken to correct a violation. 637 (d) An owner or designated physician of a controlled 638 substance medicalpain-managementclinic who concurrently 639 operates an unregistered controlled-substance medicalpain640managementclinic is subject to an administrative fine of $5,000 641 per day. 642 (e) If the owner of a controlled-substance medicalpain643managementclinic that requires registration fails to apply to 644 register the clinic upon a change of ownership and operates the 645 clinic under the new ownership, the owner is subject to a fine 646 of $5,000. 647 Section 5. Paragraphs (a) and (e) of subsection (1) and 648 paragraph (f) of subsection (2) of section 458.327, Florida 649 Statutes, are amended to read: 650 458.327 Penalty for violations.— 651 (1) Each of the following acts constitutes a felony of the 652 third degree, punishable as provided in s. 775.082, s. 775.083, 653 or s. 775.084: 654 (a) The practice of medicine or an attempt to practice 655 medicine without a license to practice in this stateFlorida. 656 (e) Knowingly operating, owning, or managing a 657 nonregistered controlled-substance medicalpain-management658 clinic that is required to be registered with the Department of 659 Health pursuant to s. 458.3265(1). 660 (2) Each of the following acts constitutes a misdemeanor of 661 the first degree, punishable as provided in s. 775.082 or s. 662 775.083: 663 (f) Knowingly prescribing or dispensing, or causing to be 664 prescribed or dispensed, controlled substances in a 665 nonregistered controlled-substance medicalpain-management666 clinic that is required to be registered with the Department of 667 Health pursuant to s. 458.3265(1). 668 Section 6. Paragraphs (oo) and (pp) of subsection (1) of 669 section 458.331, Florida Statutes, are amended to read: 670 458.331 Grounds for disciplinary action; action by the 671 board and department.— 672 (1) The following acts constitute grounds for denial of a 673 license or disciplinary action, as specified in s. 456.072(2): 674 (oo) Applicable to a licensee who serves as the designated 675 physician of a controlled-substance medicalpain-management676 clinic as defined in s. 458.3265 or s. 459.0137: 677 1. Registering a controlled-substance medicalpain678managementclinic through misrepresentation or fraud; 679 2. Procuring, or attempting to procure, the registration of 680 a controlled-substance medicalpain-managementclinic for any 681 other person by making or causing to be made, any false 682 representation; 683 3. Failing to comply with any requirement of chapter 499, 684 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the 685 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., 686 the Drug Abuse Prevention and Control Act; or chapter 893, the 687 Florida Comprehensive Drug Abuse Prevention and Control Act; 688 4. Being convicted or found guilty of, regardless of 689 adjudication to, a felony or any other crime involving moral 690 turpitude, fraud, dishonesty, or deceit in any jurisdiction of 691 the courts of this state, of any other state, or of the United 692 States; 6935. Being convicted of, or disciplined by a regulatory694agency of the Federal Government or a regulatory agency of695another state for, any offense that would constitute a violation696of this chapter;697 5.6.Being convicted of, or entering a plea of guilty or 698 nolo contendere to, regardless of adjudication, a crime in any 699 jurisdiction of the courts of this state, of any other state, or 700 of the United States which relates to the practice of, or the 701 ability to practice, a licensed health care profession; 702 6.7.Being convicted of, or entering a plea of guilty or 703 nolo contendere to, regardless of adjudication, a crime in any 704 jurisdiction of the courts of this state, of any other state, or 705 of the United States which relates to health care fraud; 706 7.8.Dispensing any medicinal drug based upon a 707 communication that purports to be a prescription as defined in 708 s. 465.003(14) or s. 893.02 if the dispensing practitioner knows 709 or has reason to believe that the purported prescription is not 710 based upon a valid practitioner-patient relationship; or 711 8.9.Failing to timely notify the board of the date of his 712 or her termination from a controlled-substance medicalpain713managementclinic as required by s. 458.3265(2). 714 (pp) Failing to timely notify the department of the theft 715 of prescription blanks from a controlled-substance medicalpain716managementclinic or a breach of other methods for prescribing 717 within 24 hours as required by s. 458.3265(2). 718 Section 7. Section 459.0137, Florida Statutes, is amended 719 to read: 720 459.0137 Controlled-substance medicalpain-management721 clinics.— 722 (1) REGISTRATION.— 723 (a) AAllprivately owned controlled-substance medical 724 clinic, facility, or officepain-managementclinics, facilities,725or offices, hereinafter referred to as a “clinic,”“clinics,”726 may not advertise services related to the dispensing of 727 medication. A controlled-substance medical clinic is a facility 728 that employs an osteopathic physician who prescribes on any 729 given day more than 25 prescriptions of Schedule II or Schedule 730 III controlled substance medications, or a combination thereof, 731which advertise in any medium for any type of pain-management732services, or employsemployan osteopathic physician who is 733primarilyengaged inthe treatment of pain by prescribing or734 dispensing controlled substance medications.,Such clinic must 735 register with the department unless: 736 1. That clinic is licensed as a facility pursuant to 737 chapter 395; 738 2. The majority of the physicians who provide services in 739 the clinic primarily provide surgical services; 740 3. The clinic is owned by a publicly held corporation whose 741 shares are traded on a national exchange or on the over-the 742 counter market and whose total assets at the end of the 743 corporation’s most recent fiscal quarter exceeded $50 million; 744 4. The clinic is affiliated with an accredited medical 745 school at which training is provided for medical students, 746 residents, or fellows; or 7475. The clinic does not prescribe or dispense controlled748substances for the treatment of pain; or749 5.6.The clinic is owned by a corporate entity exempt from 750 federal taxation under 26 U.S.C. s. 501(c)(3). 751 (b) Each clinic location shall be registered separately 752 regardless of whether the clinic is operated under the same 753 business name or management as another clinic. 754 (c) As a part of registration, a clinic must designate an 755 osteopathic, dispensing physician who is responsible for 756 complying with all requirements related to registration and 757 operation of the clinic in compliance with this section. Within 758 10 days after termination of a designated osteopathic physician, 759 the clinic must notify the department of the identity of another 760 designated physician for that clinic. The designated physician 761 shall have a full, active, and unencumbered license under 762 chapter 458 or this chapter and shall practice at the clinic 763 location for which the physician has assumed responsibility. 764 Failing to have a licensed designated osteopathic physician 765 practicing at the location of the registered clinic may be the 766 basis for a summary suspension of the clinic registration 767 certificate as described in s. 456.073(8) for a license or s. 768 120.60(6). 769 (d) The department shall deny registration to any clinic 770 that is not fully owned by a physician licensed under chapter 771 458 or this chapter or a group of physicians, each of whom is 772 licensed under chapter 458 or this chapter; or that is not a 773 health care clinic licensed under part X of chapter 400. 774 (e) The department shall deny registration to any 775 controlled-substance medicalpain-managementclinic owned by or 776 with any contractual or employment relationship with a 777 physician: 778 1. Whose Drug Enforcement Administration number has ever 779 been revoked. 780 2. Whose application for a license to prescribe, dispense, 781 or administer a controlled substance has been denied by any 782 jurisdiction. 783 3. Who has been convicted of or pleaded guilty or nolo 784 contendere to, regardless of adjudication, an offense that 785 constitutes a felony for receipt of illicit and diverted drugs, 786 including a controlled substance listed in Schedule I, Schedule 787 II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in 788 this state, any other state, or the United States. 789 (f) If the department finds upon a hearing by the probable 790 cause panel of the appropriate medical board that a controlled 791 substance medicalpain-managementclinic does not meet the 792 requirement of paragraph (d) or is owned, directly or 793 indirectly, by a person meeting any criteria listed in paragraph 794 (e), the department shall revoke the certificate of registration 795 previously issued by the department. As determined by rule, the 796 department may grant an exemption to denying a registration or 797 revoking a previously issued registration if more than 10 years 798 have elapsed since adjudication. As used in this subsection, the 799 term “convicted” includes an adjudication of guilt following a 800 plea of guilty or nolo contendere or the forfeiture of a bond 801 when charged with a crime. 802 (g) The department may revoke the clinic’s certificate of 803 registration and prohibit all physicians associated with that 804 controlled-substance medicalpain-managementclinic from 805 practicing at that clinic location based upon an annual 806 inspection and evaluation of the factors described in subsection 807 (3) and upon a final determination by the probable cause panel 808 of the appropriate medical board that any physician associated 809 with that controlled-substance medical clinic knew or should 810 have known of any violations of the factors described in 811 subsection (3). 812 (h)1. If the registration of a controlled-substance medical 813pain-managementclinic is revoked or suspended, the designated 814 physician of the controlled-substance medicalpain-management815 clinic, the owner or lessor of the controlled-substance medical 816pain-managementclinic property, the manager, and the proprietor 817 shall cease to operate the facility as a controlled-substance 818 medicalpain-managementclinic as of the effective date of the 819 suspension or revocation. 820 2. Notwithstanding subparagraph 1., the clinic’s 821 registration shall not be revoked or suspended if the clinic, 822 within 24 hours after notification of suspension or revocation, 823 appoints another designated physician who has a full, active, 824 and unencumbered license under this chapter or chapter 458 to 825 operate a controlled-substance medical clinic. 826 (i) If a controlled-substance medicalpain-management827 clinic registration is revoked or suspended, the designated 828 physician of the controlled-substance medicalpain-management829 clinic, the owner or lessor of the clinic property, the manager, 830 or the proprietor is responsible for removing all signs and 831 symbols identifying the premises as a controlled-substance 832 medicalpain-managementclinic. 833 (j) Upon the effective date of the suspension or 834 revocation, the designated physician of the controlled-substance 835 medicalpain-managementclinic shall advise the department of 836 the disposition of the medicinal drugs located on the premises. 837 The disposition is subject to the supervision and approval of 838 the department. Medicinal drugs that are purchased or held by a 839 controlled-substance medicalpain-managementclinic that is not 840 registered may be deemed adulterated pursuant to s. 499.006. 841 (k) If the clinic’s registration is revoked, any person 842 named in the registration documents of the controlled-substance 843 medicalpain-managementclinic, including persons owning or 844 operating the controlled-substance medicalpain-management845 clinic, may not, as an individual or as a part of a group, make 846 application for a permit to operate a controlled-substance 847 medicalpain-managementclinic for 5 years after the date the 848 registration is revoked upon a finding by the probable cause 849 panel, and an opportunity to be heard, the persons operating 850 such clinic knew or should have known of violations causing such 851 revocation. 852 (l) The period of suspension for the registration of a 853 controlled-substance medicalpain-managementclinic shall be 854 prescribed by the department, but may not exceed 1 year. 855 (m) A change of ownership of a registered controlled 856 substance medicalpain-managementclinic requires submission of 857 a new registration application. 858 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities 859 apply to any osteopathic physician who provides professional 860 services in a controlled-substance medicalpain-management861 clinic that is required to be registered in subsection (1). 862 (a) An osteopathic physician may not practice medicine in a 863 controlled-substance medicalpain-managementclinic, as 864 described in subsection (4), if:8651.the controlled-substance medicalpain-managementclinic 866 is not registered with the department as required by this 867 section.; or8682. Effective July 1, 2012, the physician has not869successfully completed a pain-medicine fellowship that is870accredited by the Accreditation Council for Graduate Medical871Education or the American Osteopathic Association or a pain872medicine residency that is accredited by the Accreditation873Council for Graduate Medical Education or the American874Osteopathic Association or, prior to July 1, 2012, does not875comply with rules adopted by the board.876 877Any physician who qualifies to practice medicine in a pain878management clinic pursuant to rules adopted by the Board of879Osteopathic Medicine as of July 1, 2012, may continue to880practice medicine in a pain-management clinic as long as the881physician continues to meet the qualifications set forth in the882board rules. An osteopathic physician who violates this883paragraph is subject to disciplinary action by his or her884appropriate medical regulatory board.885 (b) A person may not dispense any medication, including a 886 controlled substance, on the premises of a registered 887 controlled-substance medicalpain-managementclinic unless he or 888 she is a physician licensed under this chapter or chapter 458. 889 (c) An osteopathic physician, an advanced registered nurse 890 practitioner, or a physician assistant must perform an 891 appropriate medicala physicalexamination of a patient on the 892 same day that the osteopathic physicianhe or shedispenses or 893 prescribes a controlled substance to a patient at a controlled 894 substance medicalpain-managementclinic. AnIf theosteopathic 895 physician may not dispenseprescribes ordispensesmore than a 896 30-day supply72-hour doseof controlled substances to any 897 patientfor the treatment of chronic nonmalignant pain, the898osteopathic physician must document in the patient’s record the899reason for prescribing or dispensing that quantity. 900 (d) An osteopathic physician authorized to prescribe 901 controlled substances who practices at a controlled-substance 902 medicalpain-managementclinic is responsible for maintaining 903 the control and security of his or her prescription blanks and 904 any other method used for prescribing controlled substance pain 905 medication. The osteopathic physician shall comply with the 906 requirements for counterfeit-resistant prescription blanks in s. 907 893.065 and the rules adopted pursuant to that section. The 908 osteopathic physician shall notify, in writing, the department 909 within 24 hours after discoveringfollowingany theft or loss of 910 a prescription blank or breach of any other method for 911 prescribing controlled substancespain medication. 912 (e) The designated osteopathic physician of a controlled 913 substance medicalpain-managementclinic shall notify the 914 applicable board in writing of the date of termination of 915 employment within 10 days after terminating his or her 916 employment with a controlled-substance medicalpain-management917 clinic that is required to be registered under subsection (1). 918 (3) INSPECTION.— 919 (a) The department shall inspect the controlled-substance 920 medicalpain-managementclinic annually, including a review of 921 the patient records, to ensure that it complies with this 922 section and the rules of the Board of Osteopathic Medicine 923 adopted pursuant to subsection (4) unless the clinic is 924 accredited by a nationally recognized accrediting agency 925 approved by the Board of Osteopathic Medicine. 926 (b) During an onsite inspection, the department shall make 927 a reasonable attempt to discuss each violation with the owner or 928 designated physician of the controlled-substance medicalpain929managementclinic before issuing a formal written notification. 930 (c) Any action taken to correct a violation shall be 931 documented in writing by the owner or designated physician of 932 the controlled-substance medicalpain-managementclinic and 933 verified by followup visits by departmental personnel. 934 (4) RULEMAKING.— 935 (a) The department shall adopt rules necessary to 936 administer the registration and inspection of controlled 937 substance medicalpain-managementclinics which establish the 938 specific requirements, procedures, forms, and fees. 939 (b) The department shall adopt a rule defining what 940 constitutes practice by a designated osteopathic physician at 941 the clinic location for which the physician has assumed 942 responsibility, as set forth in subsection (1). When adopting 943 the rule, the department shall consider the number of clinic 944 employees, the location of the controlled-substance medical 945pain-managementclinic, the clinic’s hours of operation, and the 946 amount of controlled substances being prescribed, dispensed, or 947 administered at the controlled-substance medicalpain-management948 clinic. 949(c) The Board of Osteopathic Medicine shall adopt a rule950establishing the maximum number of prescriptions for Schedule II951or Schedule III controlled substances or the controlled952substance Alprazolam which may be written at any one registered953pain-management clinic during any 24-hour period.954 (c)(d)The Board of Osteopathic Medicine shall adopt rules 955 setting forth standards of practice for osteopathic physicians 956 practicing in privately owned controlled-substance medicalpain957managementclinics that primarily engage in the treatment of 958 pain by prescribing or dispensing controlled substance 959 medications. Such rules shall address, but need not be limited 960 to: 961 1. Facility operations; 962 2. Physical operations; 963 3. Infection control requirements; 964 4. Health and safety requirements; 965 5. Quality assurance requirements; 966 6. Patient records; 9677. Training requirements for all facility health care968practitioners who are not regulated by another board;969 7.8.Inspections; and 970 8.9.Data collection and reporting requirements. 971 972An osteopathic physician is primarily engaged in the treatment973of pain by prescribing or dispensing controlled substance974medications when the majority of the patients seen are975prescribed or dispensed controlled substance medications for the976treatment of chronic nonmalignant pain. Chronic nonmalignant977pain is pain unrelated to cancer which persists beyond the usual978course of the disease or the injury that is the cause of the979pain or more than 90 days after surgery.980 (5) PENALTIES; ENFORCEMENT.— 981 (a) The department may impose an administrative fine on the 982 clinic of up to $5,000 per violation for violating the 983 requirements of this section; chapter 499, the Florida Drug and 984 Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and 985 Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug 986 Abuse Prevention and Control Act; chapter 893, the Florida 987 Comprehensive Drug Abuse Prevention and Control Act; or the 988 rules of the department. In determining whether a penalty is to 989 be imposed, and in fixing the amount of the fine, the department 990 shall consider the following factors: 991 1. The gravity of the violation, including the probability 992 that death or serious physical or emotional harm to a patient 993 has resulted, or could have resulted, from the controlled 994 substance medicalpain-managementclinic’s actions or the 995 actions of the osteopathic physician, the severity of the action 996 or potential harm, and the extent to which the provisions of the 997 applicable laws or rules were violated. 998 2. What actions, if any, the owner or designated 999 osteopathic physician took to correct the violations. 1000 3. Whether there were any previous violations at the 1001 controlled-substance medicalpain-managementclinic. 1002 4. The financial benefits that the controlled-substance 1003 medicalpain-managementclinic derived from committing or 1004 continuing to commit the violation. 1005 (b) Each day a violation continues after the date fixed for 1006 termination of the violation as ordered by the department 1007 constitutes an additional, separate, and distinct violation. 1008 (c) The department may impose a fine and, in the case of an 1009 owner-operated controlled-substance medicalpain-management1010 clinic, revoke or deny a controlled-substance medicalpain1011managementclinic’s registration, if the clinic’s designated 1012 osteopathic physician knowingly and intentionally misrepresents 1013 actions taken to correct a violation. 1014 (d) An owner or designated osteopathic physician of a 1015 controlled-substance medicalpain-managementclinic who 1016 concurrently operates an unregistered controlled-substance 1017 medicalpain-managementclinic is subject to an administrative 1018 fine of $5,000 per day. 1019 (e) If the owner of a controlled-substance medicalpain1020managementclinic that requires registration fails to apply to 1021 register the clinic upon a change of ownership and operates the 1022 clinic under the new ownership, the owner is subject to a fine 1023 of $5,000. 1024 Section 8. Paragraphs (qq) and (rr) of subsection (1) of 1025 section 459.015, Florida Statutes, are amended to read: 1026 459.015 Grounds for disciplinary action; action by the 1027 board and department.— 1028 (1) The following acts constitute grounds for denial of a 1029 license or disciplinary action, as specified in s. 456.072(2): 1030 (qq) Applicable to a licensee who serves as the designated 1031 physician of a controlled-substance medicalpain-management1032 clinic as defined in s. 458.3265 or s. 459.0137: 1033 1. Registering a controlled-substance medicalpain1034managementclinic through misrepresentation or fraud; 1035 2. Procuring, or attempting to procure, the registration of 1036 a pain-management clinic for any other person by making or 1037 causing to be made, any false representation; 1038 3. Failing to comply with any requirement of chapter 499, 1039 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the 1040 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., 1041 the Drug Abuse Prevention and Control Act; or chapter 893, the 1042 Florida Comprehensive Drug Abuse Prevention and Control Act; 1043 4. Being convicted or found guilty of, regardless of 1044 adjudication to, a felony or any other crime involvingmoral1045turpitude,fraud, dishonesty, or deceit in any jurisdiction of 1046 the courts of this state, of any other state, or of the United 1047 States; 10485. Being convicted of, or disciplined by a regulatory1049agency of the Federal Government or a regulatory agency of1050another state for, any offense that would constitute a violation1051of this chapter;1052 5.6.Being convicted of, or entering a plea of guilty or 1053 nolo contendere to, regardless of adjudication, a crime in any 1054 jurisdiction of the courts of this state, of any other state, or 1055 of the United States which relates to the practice of, or the 1056 ability to practice, a licensed health care profession; 1057 6.7.Being convicted of, or entering a plea of guilty or 1058 nolo contendere to, regardless of adjudication, a crime in any 1059 jurisdiction of the courts of this state, of any other state, or 1060 of the United States which relates to health care fraud; 1061 7.8.Dispensing any medicinal drug based upon a 1062 communication that purports to be a prescription as defined in 1063 s. 465.003(14) or s. 893.02 if the dispensing practitioner knows 1064 or has reason to believe that the purported prescription is not 1065 based upon a valid practitioner-patient relationship; or 1066 8.9.Failing to timely notify the board of the date of his 1067 or her termination from a controlled-substance medicalpain1068managementclinic as required by s. 459.0137(2). 1069 (rr) Failing to timely notify the department of the theft 1070 of prescription blanks from a controlled-substance medicalpain1071managementclinic or a breach of other methods for prescribing 1072 within 24 hours as required by s. 459.0137(2). 1073 Section 9. Subsection (1) of section 465.0276, Florida 1074 Statutes, is amended to read: 1075 465.0276 Dispensing practitioner.— 1076(1)(a)A person may not dispense medicinal drugs unless 1077 licensed as a pharmacist or otherwise authorized under this 1078 chapter to do so, except that a practitioner authorized by law 1079 to prescribe drugs may dispense such drugs to her or his 1080 patients in the regular course of her or his practice in 1081 compliance with this section. 1082(b) A practitioner registered under this section may not1083dispense more than a 72-hour supply of a controlled substance1084listed in Schedule II, Schedule III, Schedule IV, or Schedule V1085of s.893.03for any patient who pays for the medication by1086cash, check, or credit card in a clinic registered under s.1087458.3265or s.459.0137. A practitioner who violates this1088paragraph commits a felony of the third degree, punishable as1089provided in s.775.082, s.775.083, or s.775.084. This1090paragraph does not apply to:10911. A practitioner who dispenses medication to a workers’1092compensation patient pursuant to chapter 440.10932. A practitioner who dispenses medication to an insured1094patient who pays by cash, check, or credit card to cover any1095applicable copayment or deductible.10963. The dispensing of complimentary packages of medicinal1097drugs to the practitioner’s own patients in the regular course1098of her or his practice without the payment of a fee or1099remuneration of any kind, whether direct or indirect, as1100provided in subsection (5).1101 Section 10. Section 893.055, Florida Statutes, is amended 1102 to read: 1103 893.055 Prescription drug monitoring program.— 1104 (1) As used in this section, the term: 1105 (a) “Patient advisory report” or “advisory report” means 1106 information provided by the department in writing, via 1107 electronic delivery, or as determined by the department, to a 1108 controlled-substance medical clinic and its employed physicians, 1109 an advanced registered nurse practitioner, a physician 1110 assistant, aprescriber, dispenser,pharmacy, or a patient 1111 concerning the dispensing of controlled substances. A 1112 controlled-substance medical clinic and its employed physicians, 1113 an advanced registered nurse practitioner, a physician 1114 assistant, or a pharmacy shall review each patient advisory 1115 report before any controlled substance is dispensed to a 1116 patient.All advisory reports are for informational purposes1117only and impose no obligations of any nature or any legal duty1118on a prescriber, dispenser, pharmacy, or patient. The patient 1119 advisory report shall be provided in accordance with s. 1120 893.13(7)(a)8. The advisory reports issued by the department are 1121 not subject to discovery or introduction into evidence in any 1122 civil or administrative action against a prescriber, dispenser, 1123 pharmacy, or patient arising out of matters that are the subject 1124 of the report; and a person who participates in preparing, 1125 reviewing, issuing, or any other activity related to an advisory 1126 report may not be permitted or required to testify in any such 1127 civil action as to any findings, recommendations, evaluations, 1128 opinions, or other actions taken in connection with preparing, 1129 reviewing, or issuing such a report. 1130 (b) “Controlled substance” means a controlled substance 1131 listed in Schedule II, Schedule III, or Schedule IV in s. 1132 893.03. 1133 (c) “Controlled-substance medical clinic” means a facility 1134 that employs a physician or osteopathic physician who prescribes 1135 on any given day more than 25 prescriptions of Schedule II or 1136 Schedule III controlled substance medications, or a combination 1137 thereof, or employs a physician or an osteopathic physician who 1138 is engaged in dispensing controlled substance medications. 1139 (d)(c)“Dispenser” means a pharmacy, dispensing pharmacist, 1140 or dispensing health care practitioner. 1141 (e)(d)“Health care practitioner” or “practitioner” means 1142 any practitioner who is subject to licensure or regulation by 1143 the department under chapter 458, chapter 459, chapter 461, 1144 chapter 462, chapter 464, chapter 465, or chapter 466. 1145 (f)(e)“Health care regulatory board” means any board for a 1146 practitioner or health care practitioner who is licensed or 1147 regulated by the department. 1148 (g)(f)“Pharmacy” means any pharmacy that is subject to 1149 licensure or regulation by the department under chapter 465 and 1150 that dispenses or delivers a controlled substance to an 1151 individual or address in this state. 1152 (h)(g)“Prescriber” means a prescribing physician, 1153 prescribing practitioner, or other prescribing health care 1154 practitioner. 1155 (i)(h)“Active investigation” means an investigation that 1156 is being conducted with a reasonable, good faith belief that it 1157 could lead to the filing of administrative, civil, or criminal 1158 proceedings, or that is ongoing and continuing and for which 1159 there is a reasonable, good faith anticipation of securing an 1160 arrest or prosecution in the foreseeable future. 1161 (j)(i)“Law enforcement agency” means the Department of Law 1162 Enforcement, a Florida sheriff’s department, a Florida police 1163 department, or a law enforcement agency of the Federal 1164 Government which enforces the laws of this state or the United 1165 States relating to controlled substances, and which its agents 1166 and officers are empowered by law to conduct criminal 1167 investigations and make arrests. 1168 (k)(j)“Program manager” means an employee of or a person 1169 contracted by the Department of Health who is designated to 1170 ensure the integrity of the prescription drug monitoring program 1171 in accordance with the requirements established in paragraphs 1172 (2)(a) and (b). 1173 (2)(a) By December 1, 20122010, the department shall 1174 design and establish a comprehensive electronic database system 1175 that has controlled substance prescriptions provided to it and 1176 that provides prescription information to a patient’s health 1177 care practitioner and pharmacist who inform the department that 1178 they wish the patient advisory report provided to them. 1179 Otherwise, the patient advisory report will not be sent to the 1180 practitioner, pharmacy, or pharmacist. The system shall be 1181 designed to provide information regarding dispensed 1182 prescriptions of controlled substances and shall not infringe 1183 upon the legitimate prescribing or dispensing of a controlled 1184 substance by a prescriber or dispenser acting in good faith and 1185 in the course of professional practice. The dispenser and the 1186 practitioners employed at or practicing at a controlled 1187 substance medical clinic shall review the comprehensive 1188 electronic database system before prescribing or dispensing any 1189 controlled substances to a patient. If the dispenser identifies 1190 or has any issues or concerns regarding the dispensing of the 1191 controlled substance medications, the dispenser shall 1192 immediately contact the prescriber before dispensing the 1193 controlled substance medication. The system shall be consistent 1194 with standards of the American Society for Automation in 1195 Pharmacy (ASAP). The electronic system shall also comply with 1196 the Health Insurance Portability and Accountability Act (HIPAA) 1197 as it pertains to protected health information (PHI), electronic 1198 protected health information (EPHI), and all other relevant 1199 state and federal privacy and security laws and regulations. The 1200 department shall establish policies and procedures as 1201 appropriate regarding the reporting, accessing the database, 1202 evaluation, management, development, implementation, operation, 1203 storage, and security of information within the system. The 1204 reporting of prescribed controlled substances shall include a 1205 dispensing transaction with a dispenser pursuant to chapter 465 1206 or through a dispensing transaction to an individual or address 1207 in this state with a pharmacy that is not located in this state 1208 but that is otherwise subject to the jurisdiction of this state 1209 as to that dispensing transaction. The reporting of patient 1210 advisory reports refers only to reports to patients, pharmacies, 1211 and practitioners. Separate reports that contain patient 1212 prescription history information and that are not patient 1213 advisory reports are provided to persons and entities as 1214 authorized in paragraphs (7)(b) and (c) and s. 893.0551. 1215 (b) The department, when the direct support organization1216receives at least $20,000 in nonstate moneys or the state1217receives at least $20,000 in federal grants for the prescription1218drug monitoring program, and in consultation with the Office of1219Drug Control,shall adopt rules as necessary concerning the 1220 reporting, accessing the database, evaluation, management, 1221 development, implementation, operation, security, and storage of 1222 information within the system, including rules for when patient 1223 advisory reports are provided to pharmacies and prescribers, if: 1224 1. The direct-support organization receives at least 1225 $20,000 in nonstate moneys for the prescription drug monitoring 1226 program; 1227 2. The state receives at least $20,000 in federal grants 1228 for the prescription drug monitoring program; or 1229 3. The department collects at least $20,000 through 1230 registration fees required by the state to dispense controlled 1231 substances. 1232 1233 The patient advisory report shall be provided in accordance with 1234 s. 893.13(7)(a)8. The department shall work with the 1235 professional health care licensure boards, such as the Board of 1236 Medicine, the Board of Osteopathic Medicine, and the Board of 1237 Pharmacy; other appropriate organizations, such as the Florida 1238 Pharmacy Association,the Office of Drug Control,the Florida 1239 Medical Association, the Florida Retail Federation, and the 1240 Florida Osteopathic Medical Association, including those 1241 relating to pain management; and the Attorney General, the 1242 Department of Law Enforcement, and the Agency for Health Care 1243 Administration to develop rules appropriate for the prescription 1244 drug monitoring program. 1245 (c) All dispensers and prescribers subject to these 1246 reporting requirements shall be notified by the department of 1247 the implementation date for such reporting requirements. 1248 (d) The program manager shall work with professional health 1249 care licensure boards and the stakeholders listed in paragraph 1250 (b) to develop rules appropriate for identifying indicators of 1251 controlled substance abuse and diversion. 1252 (3) The pharmacy dispensing the controlled substance and 1253 each prescriber who directly dispenses a controlled substance 1254 shall submit to the electronic system, by a procedure and in a 1255 format established by the department and consistent with an 1256 ASAP-approved format, the following information for inclusion in 1257 the database: 1258 (a) The name of the prescribing practitioner, the 1259 practitioner’s federal Drug Enforcement Administration 1260 registration number, the practitioner’s National Provider 1261 Identification (NPI) or other appropriate identifier, and the 1262 date of the prescription. 1263 (b) The date the prescription was filled and the method of 1264 payment, such as cash by an individual, insurance coverage 1265 through a third party, or Medicaid payment. This paragraph does 1266 not authorize the department to include individual credit card 1267 numbers or other account numbers in the database. 1268 (c) The full name, address, and date of birth of the person 1269 for whom the prescription was written. 1270 (d) The name, national drug code, quantity, and strength of 1271 the controlled substance dispensed. 1272 (e) The full name, federal Drug Enforcement Administration 1273 registration number, and address of the pharmacy or other 1274 location from which the controlled substance was dispensed. If 1275 the controlled substance was dispensed by a practitioner other 1276 than a pharmacist, the practitioner’s full name, federal Drug 1277 Enforcement Administration registration number, and address. 1278 (f) The name of the pharmacy or practitioner, other than a 1279 pharmacist, dispensing the controlled substance and the 1280 practitioner’s National Provider Identification (NPI). 1281 (g) Other appropriate identifying information as determined 1282 by department rule. 1283 (4) Each time a controlled substance is dispensed to an 1284 individual, the controlled substance shall be reported to the 1285 department through the systemas soon thereafter as possible,1286 but not more than 24 hours15 daysafterthe datethe controlled 1287 substance is dispensedunless an extension is approved by the1288department for cause as determined by rule. A dispenser must 1289 meet the reporting requirements of this section by providing the 1290 required information concerning each controlled substance that 1291 it dispensed in a department-approved, secure methodology and 1292 format. Such approved formats may include, but are not limited 1293 to, submission via the Internet, on a disc, or by use of regular 1294 mail. 1295 (5) When the following acts of dispensing or administering 1296 occur, the following are exempt from reporting under this 1297 section for that specific act of dispensing or administration: 1298 (a) A health care practitioner when administering a 1299 controlled substance directly to a patient if the amount of the 1300 controlled substance is adequate to treat the patient during 1301 that particular treatment session. 1302 (b) A pharmacist or health care practitioner when 1303 administering a controlled substance to a patient or resident 1304 receiving care as a patient at a hospital, nursing home, 1305 ambulatory surgical center, hospice, or intermediate care 1306 facility for the developmentally disabled which is licensed in 1307 this state. 1308 (c) A practitioner when administering or dispensing a 1309 controlled substance in the health care system of the Department 1310 of Corrections. 1311 (d) A practitioner when administering a controlled 1312 substance in the emergency room of a licensed hospital. 1313 (e) A health care practitioner when administering or 1314 dispensing a controlled substance to a person under the age of 1315 16. 1316 (f) A pharmacist or a dispensing practitioner when 1317 dispensing a one-time, 72-hour emergency resupply of a 1318 controlled substance to a patient. 1319 (6) The department may establish when to suspend and when 1320 to resume reporting information during a state-declared or 1321 nationally declared disaster. 1322 (7)(a) A practitioner or pharmacist who dispenses a 1323 controlled substance must submit the information required by 1324 this section in an electronic or other method in an ASAP format 1325 approved by rule of the department unless otherwise provided in 1326 this section. The cost to the dispenser in submitting the 1327 information required by this section may not be material or 1328 extraordinary. Costs not considered to be material or 1329 extraordinary include, but are not limited to, regular postage, 1330 electronic media, regular electronic mail, and facsimile 1331 charges. 1332 (b) A pharmacy, prescriber, or dispenser shall have access 1333 to information in the prescription drug monitoring program’s 1334 database which relates to a patient of that pharmacy, 1335 prescriber, or dispenser in a manner established by the 1336 department as needed for the purpose of reviewing the patient’s 1337 controlled substance prescription history. Other access to the 1338 program’s database shall be limited to the program’s manager and 1339 to the designated program and support staff, who may act only at 1340 the direction of the program manager or, in the absence of the 1341 program manager, as authorized. Access by the program manager or 1342 such designated staff is for prescription drug program 1343 management only or for management of the program’s database and 1344 its system in support of the requirements of this section and in 1345 furtherance of the prescription drug monitoring program. 1346 Confidential and exempt information in the database shall be 1347 released only as provided in paragraph (c) and s. 893.0551. 1348 (c) The following entities shall not be allowed direct 1349 access to information in the prescription drug monitoring 1350 program database but may request from the program manager and, 1351 when authorized by the program manager, the program manager’s 1352 program and support staff, information that is confidential and 1353 exempt under s. 893.0551. Prior to release, the request shall be 1354 verified as authentic and authorized with the requesting 1355 organization by the program manager, the program manager’s 1356 program and support staff, or as determined in rules by the 1357 department as being authentic and as having been authorized by 1358 the requesting entity: 1359 1. The department or its relevant health care regulatory 1360 boards responsible for the licensure, regulation, or discipline 1361 of practitioners, pharmacists, or other persons who are 1362 authorized to prescribe, administer, or dispense controlled 1363 substances and who are involved in a specific controlled 1364 substance investigation involving a designated person for one or 1365 more prescribed controlled substances. 1366 2. The Attorney General for Medicaid fraud cases involving 1367 prescribed controlled substances. 1368 3. A law enforcement agency upon determination that 1369 probable cause exists that a crime is being committed and 1370 issuance of a search warrant regarding theduring active1371investigations regardingpotential criminal activity, fraud, or 1372 theft regarding prescribed controlled substances. 1373 4. A patient or the legal guardian or designated health 1374 care surrogate of an incapacitated patient as described in s. 1375 893.0551 who, for the purpose of verifying the accuracy of the 1376 database information, submits a written and notarized request 1377 that includes the patient’s full name, address, and date of 1378 birth, and includes the same information if the legal guardian 1379 or health care surrogate submits the request. The request shall 1380 be validated by the department to verify the identity of the 1381 patient and the legal guardian or health care surrogate, if the 1382 patient’s legal guardian or health care surrogate is the 1383 requestor. Such verification is also required for any request to 1384 change a patient’s prescription history or other information 1385 related to his or her information in the electronic database. 1386 1387 Information in the database for the electronic prescription drug 1388 monitoring system is not discoverable or admissible in any civil 1389 or administrative action, except in an investigation and 1390 disciplinary proceeding by the department or the appropriate 1391 regulatory board. 1392 (d) The following entities shall not be allowed direct 1393 access to information in the prescription drug monitoring 1394 program database but may request from the program manager and, 1395 when authorized by the program manager, the program manager’s 1396 program and support staff, information that contains no 1397 identifying information of any patient, physician, health care 1398 practitioner, prescriber, or dispenser and that is not 1399 confidential and exempt: 1400 1. Department staff for the purpose of calculating 1401 performance measures pursuant to subsection (8). 1402 2. The Program Implementation and Oversight Task Force for 1403 its reporting to the Governor, the President of the Senate, and 1404 the Speaker of the House of Representatives regarding the 1405 prescription drug monitoring program. This subparagraph expires 1406 July 1, 2012. 1407 (e) All transmissions of data required by this section must 1408 comply with relevant state and federal privacy and security laws 1409 and regulations. However, any authorized agency or person under 1410 s. 893.0551 receiving such information as allowed by s. 893.0551 1411 may maintain the information received for up to 24 months before 1412 purging it from his or her records or maintain it for longer 1413 than 24 months if the information is pertinent to ongoing health 1414 care or an active law enforcement investigation or prosecution. 1415 (f) The program manager, upon determining a pattern 1416 consistent with the rules established under paragraph (2)(d) and 1417 having cause to believe a violation of s. 893.13(7)(a)8., 1418 (8)(a), or (8)(b) has occurred, may provide relevant information 1419 to the applicable law enforcement agency. 1420 (8) To assist in fulfilling program responsibilities, 1421 performance measures shall be reported annually to the Governor, 1422 the President of the Senate, and the Speaker of the House of 1423 Representatives by the department each December 1, beginning in 1424 2011. Data that does not contain patient, physician, health care 1425 practitioner, prescriber, or dispenser identifying information 1426 may be requested during the year by department employees so that 1427 the department may undertake public health care and safety 1428 initiatives that take advantage of observed trends. Performance 1429 measures may include, but are not limited to, efforts to achieve 1430 the following outcomes: 1431 (a) Reduction of the rate of inappropriate use of 1432 prescription drugs through department education and safety 1433 efforts. 1434 (b) Reduction of the quantity of pharmaceutical controlled 1435 substances obtained by individuals attempting to engage in fraud 1436 and deceit. 1437 (c) Increased coordination among partners participating in 1438 the prescription drug monitoring program. 1439 (d) Involvement of stakeholders in achieving improved 1440 patient health care and safety and reduction of prescription 1441 drug abuse and prescription drug diversion. 1442 (9) Any person who willfully and knowingly fails to report 1443 the dispensing of a controlled substance as required by this 1444 section commits a misdemeanor of the first degree, punishable as 1445 provided in s. 775.082 or s. 775.083. 1446 (10) All costs incurred by the department in administering 1447 the prescription drug monitoring program shall be funded through 1448 federal grants, registration fees for controlled-substance 1449 medical clinics, or private funding applied for or received by 1450 the state. The department may not commit funds for the 1451 monitoring program without ensuring funding is available. The 1452 prescription drug monitoring program and the implementation 1453 thereof are contingent upon receipt of thenonstatefunding 1454 provided in this subsection. The department and state government 1455 shall cooperate with the direct-support organization established 1456 pursuant to subsection (11) in seeking federal grant funds, 1457 other nonstate grant funds, gifts, donations, or other private 1458 moneys for the department so long as the costs of doing so are 1459 not considered material. Nonmaterial costs for this purpose 1460 include, but are not limited to, the costs of mailing and 1461 personnel assigned to research or apply for a grant. 1462 Notwithstanding the exemptions to competitive-solicitation 1463 requirements under s. 287.057(3)(f), the department shall comply 1464 with the competitive-solicitation requirements under s. 287.057 1465 for the procurement of any goods or services required by this 1466 section. 1467 (11) TheOffice of Drug Control, in coordination with the1468 department,may establish a direct-support organization that has 1469 a board consisting of at least five members to provide 1470 assistance, funding, and promotional support for the activities 1471 authorized for the prescription drug monitoring program. 1472 (a) As used in this subsection, the term “direct-support 1473 organization” means an organization that is: 1474 1. A Florida corporation not for profit incorporated under 1475 chapter 617, exempted from filing fees, and approved by the 1476 Department of State. 1477 2. Organized and operated to conduct programs and 1478 activities; raise funds; request and receive grants, gifts, and 1479 bequests of money; acquire, receive, hold, and invest, in its 1480 own name, securities, funds, objects of value, or other 1481 property, either real or personal; and make expenditures or 1482 provide funding to or for the direct or indirect benefit of the 1483 department in the furtherance of the prescription drug 1484 monitoring program. 1485 (b) The direct-support organization is not considered a 1486 lobbying firm within the meaning of s. 11.045. 1487 (c) The State Surgeon Generaldirector of the Office of1488Drug Controlshall appoint a board of directors for the direct 1489 support organization. The State Surgeon Generaldirectormay 1490 designateemployees of the Office of Drug Control,state 1491 employees other than state employees from the department, and 1492 any other nonstate employees as appropriate, to serve on the 1493 board.Members of the board shall serve at the pleasure of the1494director of the Office of Drug Control.The State Surgeon 1495 Generaldirectorshall provide guidance to members of the board 1496 to ensure that moneys received by the direct-support 1497 organization are not received from inappropriate sources. 1498 Inappropriate sources include, but are not limited to, donors, 1499 grantors, persons, or organizations that may monetarily or 1500 substantively benefit from the purchase of goods or services by 1501 the department in furtherance of the prescription drug 1502 monitoring program. 1503 (d) The direct-support organization shall operate under 1504 written contract with the departmentOffice of Drug Control. The 1505 contract must, at a minimum, provide for: 1506 1. Approval of the articles of incorporation and bylaws of 1507 the direct-support organization by the departmentOffice of Drug1508Control. 1509 2. Submission of an annual budget for the approval of the 1510 departmentOffice of Drug Control. 1511 3. Certification by the Office of Drug Control in 1512 consultation with the department that the direct-support 1513 organization is complying with the terms of the contract in a 1514 manner consistent with and in furtherance of the goals and 1515 purposes of the prescription drug monitoring program and in the 1516 best interests of the state. Such certification must be made 1517 annually and reported in the official minutes of a meeting of 1518 the direct-support organization. 1519 4. The reversion, without penalty,to the Office of Drug1520Control,orto the stateif the Office of Drug Control ceases to1521exist,of all moneys and property held in trust by the direct 1522 support organization for the benefit of the prescription drug 1523 monitoring program if the direct-support organization ceases to 1524 exist or if the contract is terminated. 1525 5. The fiscal year of the direct-support organization, 1526 which must begin July 1 of each year and end June 30 of the 1527 following year. 1528 6. The disclosure of the material provisions of the 1529 contract to donors of gifts, contributions, or bequests, 1530 including such disclosure on all promotional and fundraising 1531 publications, and an explanation to such donors of the 1532 distinction between the departmentOffice of Drug Controland 1533 the direct-support organization. 1534 7. The direct-support organization’s collecting, expending, 1535 and providing of funds to the department for the development, 1536 implementation, and operation of the prescription drug 1537 monitoring program as described in this section and s. 2, 1538 chapter 2009-198, Laws of Florida, as long as the task force is 1539 authorized. The direct-support organization may collect and 1540 expend funds to be used for the functions of the direct-support 1541 organization’s board of directors, as necessary and approved by 1542 the State Surgeon Generaldirectorof the Office of Drug1543Control. In addition, the direct-support organization may 1544 collect and provide funding to the department in furtherance of 1545 the prescription drug monitoring program by: 1546 a. Establishing and administering the prescription drug 1547 monitoring program’s electronic database, including hardware and 1548 software. 1549 b. Conducting studies on the efficiency and effectiveness 1550 of the program to include feasibility studies as described in 1551 subsection (13). 1552 c. Providing funds for future enhancements of the program 1553 within the intent of this section. 1554 d. Providing user training of the prescription drug 1555 monitoring program, including distribution of materials to 1556 promote public awareness and education and conducting workshops 1557 or other meetings, for health care practitioners, pharmacists, 1558 and others as appropriate. 1559 e. Providing funds for travel expenses. 1560 f. Providing funds for administrative costs, including 1561 personnel, audits, facilities, and equipment. 1562 g. Fulfilling all other requirements necessary to implement 1563 and operate the program as outlined in this section. 1564 (e) The activities of the direct-support organization must 1565 be consistent with the goals and mission of the department 1566Office of Drug Control, as determined by the office in1567consultation with the department,and in the best interests of 1568 the state. The direct-support organization must obtain a written 1569 approval from the director of the Office of Drug Control for any 1570 activities in support of the prescription drug monitoring 1571 program before undertaking those activities. 1572 (f) TheOffice of Drug Control, in consultation with the1573 department, may permit, without charge, appropriate use of 1574 administrative services, property, and facilities of theOffice1575of Drug Control and thedepartment by the direct-support 1576 organization, subject to this section. The use must be directly 1577 in keeping with the approved purposes of the direct-support 1578 organization and may not be made at times or places that would 1579 unreasonably interfere with opportunities for the public to use 1580 such facilities for established purposes. Any moneys received 1581 from rentals of facilities and properties managed by theOffice1582of Drug Control and thedepartment may be heldby the Office of1583Drug Control orin a separate depository account in the name of 1584 the direct-support organizationand subject to the provisions of1585the letter of agreement with the Office of Drug Control.The1586letter of agreement must provide that any funds held in the1587separate depository account in the name of the direct-support1588organization must revert to the Office of Drug Control if the1589direct-support organization is no longer approved by the Office1590of Drug Control to operate in the best interests of the state.1591(g) The Office of Drug Control, in consultation with the1592department, may adopt rules under s.120.54to govern the use of1593administrative services, property, or facilities of the1594department or office by the direct-support organization.1595 (g)(h)The departmentOffice of Drug Controlmay not permit 1596 the use of any administrative services, property, or facilities 1597 of the state by a direct-support organization if that 1598 organization does not provide equal membership and employment 1599 opportunities to all persons regardless of race, color, 1600 religion, gender, age, or national origin. 1601 (h)(i)The direct-support organization shall provide for an 1602 independent annual financial audit in accordance with s. 1603 215.981. Copies of the audit shall be provided to the Office of 1604 Drug Control and the Office of Policy and Budget in the 1605 Executive Office of the Governor. 1606 (i)(j)The direct-support organization may not exercise any 1607 power under s. 617.0302(12) or (16). 1608 (12) A prescriber or dispenser may have access to the 1609 information under this section which relates to a patient of 1610 that prescriber or dispenser as needed for the purpose of 1611 reviewing the patient’s controlled drug prescription history. A 1612 prescriber or dispenser acting in good faith is immune from any 1613 civil, criminal, or administrative liability that might 1614 otherwise be incurred or imposed for receiving or using 1615 information from the prescription drug monitoring program. This 1616 subsection does not create a private cause of action, and a 1617 person may not recover damages against a prescriber or dispenser 1618 authorized to access information under this subsection for 1619 accessing or failing to access such information. 1620 (13) To the extent that funding is provided for such 1621 purpose through federal or private grants or gifts and other 1622 types of available moneys, the department, in collaboration with1623the Office of Drug Control,shall study the feasibility of 1624 enhancing the prescription drug monitoring program for the 1625 purposes of public health initiatives and statistical reporting 1626 that respects the privacy of the patient, the prescriber, and 1627 the dispenser. Such a study shall be conducted in order to 1628 further improve the quality of health care services and safety 1629 by improving the prescribing and dispensing practices for 1630 prescription drugs, taking advantage of advances in technology, 1631 reducing duplicative prescriptions and the overprescribing of 1632 prescription drugs, and reducing drug abuse. The requirements of 1633 the National All Schedules Prescription Electronic Reporting 1634 (NASPER) Act are authorized in order to apply for federal NASPER 1635 funding. In addition, the direct-support organization shall 1636 provide funding for the department, in collaboration with the1637Office of Drug Control,to conduct training for health care 1638 practitioners and other appropriate persons in using the 1639 monitoring program to support the program enhancements. 1640 (14) A pharmacist, pharmacy, or dispensing health care 1641 practitioner or his or her agent, before releasing a controlled 1642 substance to any person not known to such dispenser, shall 1643 require the person purchasing, receiving, or otherwise acquiring 1644 the controlled substance to present valid photographic 1645 identification or other verification of his or her identity to 1646 the dispenser. If the person does not have proper 1647 identification, the dispenser may verify the validity of the 1648 prescription and the identity of the patient with the prescriber 1649 or his or her authorized agent. Verification of health plan 1650 eligibility through a real-time inquiry or adjudication system 1651 will be considered to be proper identification. This subsection 1652 does not apply in an institutional setting or to a long-term 1653 care facility, including, but not limited to, an assisted living 1654 facility or a hospital to which patients are admitted. As used 1655 in this subsection, the term “proper identification” means an 1656 identification that is issued by a state or the Federal 1657 Government containing the person’s photograph, printed name, and 1658 signature or a document considered acceptable under 8 C.F.R. s. 1659 274a.2(b)(1)(v)(A) and (B). 1660 (15) The Agency for Health Care Administration shall 1661 continue the promotion of electronic prescribing by health care 1662 practitioners, health care facilities, and pharmacies under s. 1663 408.0611. 1664 (16) By December 1, 2011October 1, 2010, the department 1665 shall adopt rules pursuant to ss. 120.536(1) and 120.54 to 1666 administer the provisions of this section, which shall include 1667 as necessary the reporting, accessing, evaluation, management, 1668 development, implementation, operation, and storage of 1669 information within the monitoring program’s system. 1670 Section 11. Subsection (4) of section 893.0551, Florida 1671 Statutes, is amended to read: 1672 893.0551 Public records exemption for the prescription drug 1673 monitoring program.— 1674 (4) The department shall disclose such confidential and 1675 exempt information to the applicable law enforcement agency in 1676 accordance with s. 893.055(7)(f). The law enforcement agency may 1677 disclose the confidential and exempt information received from 1678 the department to a criminal justice agency as defined in s. 1679 119.011 pursuant to a search warrantas part of an active1680investigationthat is specific to a violation of s. 1681 893.13(7)(a)8., s. 893.13(8)(a), or s. 893.13(8)(b). 1682 Section 12. This act shall take effect July 1, 2011.