CS for CS for CS for SB 1192 First Engrossed
20131192e1
1 A bill to be entitled
2 An act relating to the provision of health care with
3 controlled substances; amending s. 456.44, F.S.;
4 limiting the application of requirements for
5 prescribing controlled substances; requiring a
6 physician to consult the prescription drug monitoring
7 program database before prescribing certain controlled
8 substances; authorizing the Board of Medicine and the
9 Board of Osteopathic Medicine to adopt a penalty for
10 failure to consult the database; exempting nursing
11 home residents and certain physicians from
12 requirements regarding prescriptions of controlled
13 substances; amending s. 465.003, F.S.; defining a
14 term; conforming a cross-reference; creating s.
15 465.0065, F.S.; providing notice requirements for
16 inspection of a pharmacy; amending s. 465.016, F.S.;
17 providing additional grounds for disciplinary action;
18 conforming a cross-reference; amending s. 465.022,
19 F.S.; conforming a cross-reference; requiring a
20 pharmacy permittee to commence operations within 180
21 days after permit issuance or show good cause why
22 operations were not commenced; requiring the Board of
23 Pharmacy to establish rules; requiring a pharmacy
24 permittee to be supervised by a prescription
25 department manager or consultant pharmacist of record;
26 amending s. 465.023, F.S.; providing additional
27 grounds for disciplinary action; conforming a cross
28 reference; creating s. 465.1902, F.S.; providing that
29 the regulation of pharmacies and pharmacists is
30 preempted to the state; providing that a local
31 ordinance, rule, or regulation may not be enacted or
32 remain in effect which regulates or attempts to
33 regulate pharmacies or pharmacists in subject matters
34 regulated under ch. 465, F.S.; amending s. 893.055,
35 F.S.; deleting obsolete provisions; requiring a
36 designated agent under the supervision of a health
37 care practitioner to have access to information in the
38 prescription drug monitoring program’s database;
39 deleting a provision that prohibits funds from
40 prescription drug manufacturers to be used to
41 implement the prescription drug monitoring program;
42 authorizing the prescription drug monitoring program
43 to be funded by state funds; revising the sources of
44 money which are inappropriate for the direct-support
45 organization of the prescription drug monitoring
46 program to receive; amending s. 893.0551, F.S.;
47 requiring the Department of Health to disclose certain
48 confidential and exempt information to a designated
49 agent of a health care practitioner or pharmacist
50 under certain circumstances; creating s. 893.0552,
51 F.S.; providing that regulation of the licensure,
52 standards of practice, and operation of pain
53 management clinics is preempted to the state under
54 certain circumstances; authorizing a local government
55 or political subdivision to enact certain ordinances;
56 amending ss. 409.9201, 458.331, 459.015, 465.014,
57 465.015, 465.0156, 465.0197, 465.1901, 499.003, and
58 893.02, F.S.; conforming cross-references; providing
59 an effective date.
60
61 Be It Enacted by the Legislature of the State of Florida:
62
63 Section 1. Section 456.44, Florida Statutes, is amended to
64 read:
65 456.44 Controlled substance prescribing.—
66 (1) DEFINITIONS.—
67 (a) “Addiction medicine specialist” means a board-certified
68 psychiatrist with a subspecialty certification in addiction
69 medicine or who is eligible for such subspecialty certification
70 in addiction medicine, an addiction medicine physician certified
71 or eligible for certification by the American Society of
72 Addiction Medicine, or an osteopathic physician who holds a
73 certificate of added qualification in Addiction Medicine through
74 the American Osteopathic Association.
75 (b) “Adverse incident” means any incident set forth in s.
76 458.351(4)(a)-(e) or s. 459.026(4)(a)-(e).
77 (c) “Board-certified pain management physician” means a
78 physician who possesses board certification in pain medicine by
79 the American Board of Pain Medicine, board certification by the
80 American Board of Interventional Pain Physicians, or board
81 certification or subcertification in pain management or pain
82 medicine by a specialty board recognized by the American
83 Association of Physician Specialists or the American Board of
84 Medical Specialties or an osteopathic physician who holds a
85 certificate in Pain Management by the American Osteopathic
86 Association.
87 (d) “Board eligible” means successful completion of an
88 anesthesia, physical medicine and rehabilitation, rheumatology,
89 or neurology residency program approved by the Accreditation
90 Council for Graduate Medical Education or the American
91 Osteopathic Association for a period of 6 years from successful
92 completion of such residency program.
93 (e) “Chronic nonmalignant pain” means pain unrelated to
94 cancer which persists beyond the usual course of disease or the
95 injury that is the cause of the pain or more than 90 days after
96 surgery.
97 (f) “Mental health addiction facility” means a facility
98 licensed under chapter 394 or chapter 397.
99 (2) REGISTRATION.—Effective January 1, 2012, A physician
100 licensed under chapter 458, chapter 459, chapter 461, or chapter
101 466 who prescribes more than a 30-day supply of any controlled
102 substance, listed in Schedule II, Schedule III, or Schedule IV
103 as defined in s. 893.03, over a 6-month period to any one
104 patient for the treatment of chronic nonmalignant pain, must:
105 (a) Designate himself or herself as a controlled substance
106 prescribing practitioner on the physician’s practitioner
107 profile.
108 (b) Comply with the requirements of this section and
109 applicable board rules.
110 (3) STANDARDS OF PRACTICE.—The standards of practice in
111 this section do not supersede the level of care, skill, and
112 treatment recognized in general law related to health care
113 licensure.
114 (a) A complete medical history and a physical examination
115 must be conducted before beginning any treatment and must be
116 documented in the medical record. The exact components of the
117 physical examination shall be left to the judgment of the
118 clinician who is expected to perform a physical examination
119 proportionate to the diagnosis that justifies a treatment. The
120 medical record must, at a minimum, document the nature and
121 intensity of the pain, current and past treatments for pain,
122 underlying or coexisting diseases or conditions, the effect of
123 the pain on physical and psychological function, a review of
124 previous medical records, previous diagnostic studies, and
125 history of alcohol and substance abuse. The medical record shall
126 also document the presence of one or more recognized medical
127 indications for the use of a controlled substance. Each
128 registrant must develop a written plan for assessing each
129 patient’s risk of aberrant drug-related behavior, which may
130 include patient drug testing. Registrants must assess each
131 patient’s risk for aberrant drug-related behavior and monitor
132 that risk on an ongoing basis in accordance with the plan.
133 (b) Before or during a new patient’s visit for services for
134 the treatment of pain at a pain-management clinic registered
135 under s. 458.3265 or s. 459.0137, a physician shall consult the
136 prescription drug monitoring program database provided under s.
137 893.055(2)(a) before prescribing a controlled substance listed
138 in Schedule II or Schedule III in s. 893.03. The physician may
139 designate an agent under his or her supervision to consult the
140 database. The Board of Medicine under chapter 458 and the Board
141 of Osteopathic Medicine under chapter 459 shall adopt rules to
142 establish a penalty for a physician who does not comply with
143 this subsection.
144 (c)(b) Each registrant must develop a written
145 individualized treatment plan for each patient. The treatment
146 plan shall state objectives that will be used to determine
147 treatment success, such as pain relief and improved physical and
148 psychosocial function, and shall indicate if any further
149 diagnostic evaluations or other treatments are planned. After
150 treatment begins, the physician shall adjust drug therapy to the
151 individual medical needs of each patient. Other treatment
152 modalities, including a rehabilitation program, shall be
153 considered depending on the etiology of the pain and the extent
154 to which the pain is associated with physical and psychosocial
155 impairment. The interdisciplinary nature of the treatment plan
156 shall be documented.
157 (d)(c) The physician shall discuss the risks and benefits
158 of the use of controlled substances, including the risks of
159 abuse and addiction, as well as physical dependence and its
160 consequences, with the patient, persons designated by the
161 patient, or the patient’s surrogate or guardian if the patient
162 is incompetent. The physician shall use a written controlled
163 substance agreement between the physician and the patient
164 outlining the patient’s responsibilities, including, but not
165 limited to:
166 1. Number and frequency of controlled substance
167 prescriptions and refills.
168 2. Patient compliance and reasons for which drug therapy
169 may be discontinued, such as a violation of the agreement.
170 3. An agreement that controlled substances for the
171 treatment of chronic nonmalignant pain shall be prescribed by a
172 single treating physician unless otherwise authorized by the
173 treating physician and documented in the medical record.
174 (e)(d) The patient shall be seen by the physician at
175 regular intervals, not to exceed 3 months, to assess the
176 efficacy of treatment, ensure that controlled substance therapy
177 remains indicated, evaluate the patient’s progress toward
178 treatment objectives, consider adverse drug effects, and review
179 the etiology of the pain. Continuation or modification of
180 therapy shall depend on the physician’s evaluation of the
181 patient’s progress. If treatment goals are not being achieved,
182 despite medication adjustments, the physician shall reevaluate
183 the appropriateness of continued treatment. The physician shall
184 monitor patient compliance in medication usage, related
185 treatment plans, controlled substance agreements, and
186 indications of substance abuse or diversion at a minimum of 3
187 month intervals.
188 (f)(e) The physician shall refer the patient as necessary
189 for additional evaluation and treatment in order to achieve
190 treatment objectives. Special attention shall be given to those
191 patients who are at risk for misusing their medications and
192 those whose living arrangements pose a risk for medication
193 misuse or diversion. The management of pain in patients with a
194 history of substance abuse or with a comorbid psychiatric
195 disorder requires extra care, monitoring, and documentation and
196 requires consultation with or referral to an addiction medicine
197 specialist or psychiatrist.
198 (g)(f) A physician registered under this section must
199 maintain accurate, current, and complete records that are
200 accessible and readily available for review and comply with the
201 requirements of this section, the applicable practice act, and
202 applicable board rules. The medical records must include, but
203 are not limited to:
204 1. The complete medical history and a physical examination,
205 including history of drug abuse or dependence.
206 2. Diagnostic, therapeutic, and laboratory results.
207 3. Evaluations and consultations.
208 4. Treatment objectives.
209 5. Discussion of risks and benefits.
210 6. Treatments.
211 7. Medications, including date, type, dosage, and quantity
212 prescribed.
213 8. Instructions and agreements.
214 9. Periodic reviews.
215 10. Results of any drug testing.
216 11. A photocopy of the patient’s government-issued photo
217 identification.
218 12. If a written prescription for a controlled substance is
219 given to the patient, a duplicate of the prescription.
220 13. The physician’s full name presented in a legible
221 manner.
222 (h)(g) Patients with signs or symptoms of substance abuse
223 shall be immediately referred to a board-certified pain
224 management physician, an addiction medicine specialist, or a
225 mental health addiction facility as it pertains to drug abuse or
226 addiction unless the physician is board-certified or board
227 eligible in pain management. Throughout the period of time
228 before receiving the consultant’s report, a prescribing
229 physician shall clearly and completely document medical
230 justification for continued treatment with controlled substances
231 and those steps taken to ensure medically appropriate use of
232 controlled substances by the patient. Upon receipt of the
233 consultant’s written report, the prescribing physician shall
234 incorporate the consultant’s recommendations for continuing,
235 modifying, or discontinuing controlled substance therapy. The
236 resulting changes in treatment shall be specifically documented
237 in the patient’s medical record. Evidence or behavioral
238 indications of diversion shall be followed by discontinuation of
239 controlled substance therapy, and the patient shall be
240 discharged, and all results of testing and actions taken by the
241 physician shall be documented in the patient’s medical record.
242
243 This section subsection does not apply to a board-eligible or
244 board-certified anesthesiologist, physiatrist, rheumatologist,
245 or neurologist, or to a board-certified physician who has
246 surgical privileges at a hospital or ambulatory surgery center
247 and primarily provides surgical services. This section
248 subsection does not apply to a board-eligible or board-certified
249 medical specialist who has also completed a fellowship in pain
250 medicine approved by the Accreditation Council for Graduate
251 Medical Education or the American Osteopathic Association, or
252 who is board eligible or board certified in pain medicine by the
253 American Board of Pain Medicine or a board approved by the
254 American Board of Medical Specialties or the American
255 Osteopathic Association and performs interventional pain
256 procedures of the type routinely billed using surgical codes.
257 This section subsection does not apply to a physician who
258 prescribes medically necessary controlled substances for a
259 patient during an inpatient stay in a hospital licensed under
260 chapter 395 or to a resident in a facility licensed under part
261 II of chapter 400. This section does not apply to a physician
262 licensed under chapter 458 or chapter 459 who writes fewer than
263 50 prescriptions for a controlled substance for all of his or
264 her patients during a 1-year period.
265 Section 2. Present subsections (1) through (17) of section
266 465.003, Florida Statutes, are renumbered as subsections (2)
267 through (18), respectively, paragraph (a) of present subsection
268 (11) of that section is amended, and a new subsection (1) is
269 added to that section, to read:
270 465.003 Definitions.—As used in this chapter, the term:
271 (1) “Abandoned” means the status of a pharmacy permit of a
272 person or entity that was issued the permit but fails to
273 commence pharmacy operations within 180 days after issuance of
274 the permit without good cause or fails to follow pharmacy
275 closure requirements as set by the board.
276 (12)(11)(a) “Pharmacy” includes a community pharmacy, an
277 institutional pharmacy, a nuclear pharmacy, a special pharmacy,
278 and an Internet pharmacy.
279 1. The term “community pharmacy” includes every location
280 where medicinal drugs are compounded, dispensed, stored, or sold
281 or where prescriptions are filled or dispensed on an outpatient
282 basis.
283 2. The term “institutional pharmacy” includes every
284 location in a hospital, clinic, nursing home, dispensary,
285 sanitarium, extended care facility, or other facility,
286 hereinafter referred to as “health care institutions,” where
287 medicinal drugs are compounded, dispensed, stored, or sold.
288 3. The term “nuclear pharmacy” includes every location
289 where radioactive drugs and chemicals within the classification
290 of medicinal drugs are compounded, dispensed, stored, or sold.
291 The term “nuclear pharmacy” does not include hospitals licensed
292 under chapter 395 or the nuclear medicine facilities of such
293 hospitals.
294 4. The term “special pharmacy” includes every location
295 where medicinal drugs are compounded, dispensed, stored, or sold
296 if such locations are not otherwise defined in this subsection.
297 5. The term “Internet pharmacy” includes locations not
298 otherwise licensed or issued a permit under this chapter, within
299 or outside this state, which use the Internet to communicate
300 with or obtain information from consumers in this state and use
301 such communication or information to fill or refill
302 prescriptions or to dispense, distribute, or otherwise engage in
303 the practice of pharmacy in this state. Any act described in
304 this definition constitutes the practice of pharmacy as defined
305 in subsection (14)(13).
306 Section 3. Section 465.0065, Florida Statutes, is created
307 to read:
308 465.0065 Notices; form and service.—Each notice served by
309 the department pursuant to this chapter must be in writing and
310 must be delivered personally by an agent of the department or by
311 certified mail to the pharmacy permittee or licensee. If the
312 pharmacy permittee or licensee refuses to accept service or
313 evades service or if the agent is otherwise unable to carry out
314 service after due diligence, the department may post the notice
315 in a conspicuous place at the pharmacy or at the home or
316 business address for the licensee.
317 Section 4. Paragraphs (e) and (s) of subsection (1) of
318 section 465.016, Florida Statutes, are amended, and paragraph
319 (u) is added to that subsection, to read:
320 465.016 Disciplinary actions.—
321 (1) The following acts constitute grounds for denial of a
322 license or disciplinary action, as specified in s. 456.072(2):
323 (e) Violating chapter 499; 21 U.S.C. ss. 301-392, known as
324 the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et
325 seq., known as the Comprehensive Drug Abuse Prevention and
326 Control Act; or chapter 893 or rules adopted thereunder.
327 (s) Dispensing any medicinal drug based upon a
328 communication that purports to be a prescription as defined by
329 s. 465.003 s. 465.003(14) or s. 893.02 when the pharmacist knows
330 or has reason to believe that the purported prescription is not
331 based upon a valid practitioner-patient relationship.
332 (u) Misappropriating drugs, supplies, or equipment from a
333 pharmacy permittee.
334 Section 5. Paragraph (j) of subsection (5) of section
335 465.022, Florida Statutes, is amended, present subsections (10)
336 through (14) are renumbered as subsections (11) through (15),
337 respectively, present subsection (10) of that section is
338 amended, and a new subsection (10) is added to that section, to
339 read:
340 465.022 Pharmacies; general requirements; fees.—
341 (5) The department or board shall deny an application for a
342 pharmacy permit if the applicant or an affiliated person,
343 partner, officer, director, or prescription department manager
344 or consultant pharmacist of record of the applicant:
345 (j) Has dispensed any medicinal drug based upon a
346 communication that purports to be a prescription as defined by
347 s. 465.003 s. 465.003(14) or s. 893.02 when the pharmacist knows
348 or has reason to believe that the purported prescription is not
349 based upon a valid practitioner-patient relationship that
350 includes a documented patient evaluation, including history and
351 a physical examination adequate to establish the diagnosis for
352 which any drug is prescribed and any other requirement
353 established by board rule under chapter 458, chapter 459,
354 chapter 461, chapter 463, chapter 464, or chapter 466.
355
356 For felonies in which the defendant entered a plea of guilty or
357 nolo contendere in an agreement with the court to enter a
358 pretrial intervention or drug diversion program, the department
359 shall deny the application if upon final resolution of the case
360 the licensee has failed to successfully complete the program.
361 (10) The permittee shall commence pharmacy operations
362 within 180 days after issuance of the permit, or show good cause
363 to the department why pharmacy operations were not commenced.
364 Commencement of pharmacy operations includes, but is not limited
365 to, acts within the scope of the practice of pharmacy, ordering
366 or receiving drugs, and other similar activities. The board
367 shall establish rules regarding commencement of pharmacy
368 operations.
369 (11)(10) A pharmacy permittee shall be supervised by a
370 prescription department manager or consultant pharmacist of
371 record at all times. A permittee must notify the department, on
372 a form approved by the board, within 10 days after any change in
373 prescription department manager or consultant pharmacist of
374 record.
375 Section 6. Subsection (1) of section 465.023, Florida
376 Statutes, is amended to read:
377 465.023 Pharmacy permittee; disciplinary action.—
378 (1) The department or the board may revoke or suspend the
379 permit of any pharmacy permittee, and may fine, place on
380 probation, or otherwise discipline any pharmacy permittee if the
381 permittee, or any affiliated person, partner, officer, director,
382 or agent of the permittee, including a person fingerprinted
383 under s. 465.022(3), has:
384 (a) Obtained a permit by misrepresentation or fraud or
385 through an error of the department or the board;
386 (b) Attempted to procure, or has procured, a permit for any
387 other person by making, or causing to be made, any false
388 representation;
389 (c) Violated any of the requirements of this chapter or any
390 of the rules of the Board of Pharmacy; of chapter 499, known as
391 the “Florida Drug and Cosmetic Act”; of 21 U.S.C. ss. 301-392,
392 known as the “Federal Food, Drug, and Cosmetic Act”; of 21
393 U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse
394 Prevention and Control Act; or of chapter 893 or rules adopted
395 thereunder;
396 (d) Been convicted or found guilty, regardless of
397 adjudication, of a felony or any other crime involving moral
398 turpitude in any of the courts of this state, of any other
399 state, or of the United States;
400 (e) Been convicted or disciplined by a regulatory agency of
401 the Federal Government or a regulatory agency of another state
402 for any offense that would constitute a violation of this
403 chapter;
404 (f) Been convicted of, or entered a plea of guilty or nolo
405 contendere to, regardless of adjudication, a crime in any
406 jurisdiction which relates to the practice of, or the ability to
407 practice, the profession of pharmacy;
408 (g) Been convicted of, or entered a plea of guilty or nolo
409 contendere to, regardless of adjudication, a crime in any
410 jurisdiction which relates to health care fraud; or
411 (h) Dispensed any medicinal drug based upon a communication
412 that purports to be a prescription as defined by s. 465.003 s.
413 465.003(14) or s. 893.02 when the pharmacist knows or has reason
414 to believe that the purported prescription is not based upon a
415 valid practitioner-patient relationship that includes a
416 documented patient evaluation, including history and a physical
417 examination adequate to establish the diagnosis for which any
418 drug is prescribed and any other requirement established by
419 board rule under chapter 458, chapter 459, chapter 461, chapter
420 463, chapter 464, or chapter 466.
421 Section 7. Section 465.1902, Florida Statutes, is created
422 to read:
423 465.1902 Preemption.—The regulation of pharmacies and
424 pharmacists is expressly preempted to the state. No local
425 ordinance, rule, or regulation shall be enacted or remain in
426 effect which regulates or attempts to regulate pharmacies or
427 pharmacists in subject matters regulated under this chapter,
428 including, but not limited to, licensure, discipline, pharmacy
429 permitting, and the dispensing of controlled substances.
430 Section 8. Paragraph (b) of subsection (2), paragraph (b)
431 of subsection (7), subsection (10), and paragraph (c) of
432 subsection (11) of section 893.055, Florida Statutes, are
433 amended to read:
434 893.055 Prescription drug monitoring program.—
435 (2)
436 (b) The department, when the direct support organization
437 receives at least $20,000 in nonstate moneys or the state
438 receives at least $20,000 in federal grants for the prescription
439 drug monitoring program, shall adopt rules as necessary
440 concerning the reporting, accessing the database, evaluation,
441 management, development, implementation, operation, security,
442 and storage of information within the system, including rules
443 for when patient advisory reports are provided to pharmacies and
444 prescribers. The patient advisory report shall be provided in
445 accordance with s. 893.13(7)(a)8. The department shall work with
446 the professional health care licensure boards, such as the Board
447 of Medicine, the Board of Osteopathic Medicine, and the Board of
448 Pharmacy; other appropriate organizations, such as the Florida
449 Pharmacy Association, the Florida Medical Association, the
450 Florida Retail Federation, and the Florida Osteopathic Medical
451 Association, including those relating to pain management; and
452 the Attorney General, the Department of Law Enforcement, and the
453 Agency for Health Care Administration to develop rules
454 appropriate for the prescription drug monitoring program.
455 (7)
456 (b) A pharmacy, prescriber, designated agent under the
457 supervision of a health care practitioner, or dispenser shall
458 have access to information in the prescription drug monitoring
459 program’s database which relates to a patient of that pharmacy,
460 prescriber, or dispenser in a manner established by the
461 department as needed for the purpose of reviewing the patient’s
462 controlled substance prescription history. Other access to the
463 program’s database shall be limited to the program’s manager and
464 to the designated program and support staff, who may act only at
465 the direction of the program manager or, in the absence of the
466 program manager, as authorized. Access by the program manager or
467 such designated staff is for prescription drug program
468 management only or for management of the program’s database and
469 its system in support of the requirements of this section and in
470 furtherance of the prescription drug monitoring program.
471 Confidential and exempt information in the database shall be
472 released only as provided in paragraph (c) and s. 893.0551. The
473 program manager, designated program and support staff who act at
474 the direction of or in the absence of the program manager, and
475 any individual who has similar access regarding the management
476 of the database from the prescription drug monitoring program
477 shall submit fingerprints to the department for background
478 screening. The department shall follow the procedure established
479 by the Department of Law Enforcement to request a statewide
480 criminal history record check and to request that the Department
481 of Law Enforcement forward the fingerprints to the Federal
482 Bureau of Investigation for a national criminal history record
483 check.
484 (10) All costs incurred by the department in administering
485 the prescription drug monitoring program shall be funded through
486 state funds, federal grants, or private funding applied for or
487 received by the state. The department may not commit funds for
488 the monitoring program without ensuring funding is available.
489 The prescription drug monitoring program and the implementation
490 thereof are contingent upon receipt of the nonstate funding. The
491 department and state government shall cooperate with the direct
492 support organization established pursuant to subsection (11) in
493 seeking state funds, federal grant funds, other nonstate grant
494 funds, gifts, donations, or other private moneys for the
495 department if so long as the costs of doing so are not
496 considered material. Nonmaterial costs for this purpose include,
497 but are not limited to, the costs of mailing and personnel
498 assigned to research or apply for a grant. Notwithstanding the
499 exemptions to competitive-solicitation requirements under s.
500 287.057(3)(f), the department shall comply with the competitive
501 solicitation requirements under s. 287.057 for the procurement
502 of any goods or services required by this section. Funds
503 provided, directly or indirectly, by prescription drug
504 manufacturers may not be used to implement the program.
505 (11) The department may establish a direct-support
506 organization that has a board consisting of at least five
507 members to provide assistance, funding, and promotional support
508 for the activities authorized for the prescription drug
509 monitoring program.
510 (c) The State Surgeon General shall appoint a board of
511 directors for the direct-support organization. Members of the
512 board shall serve at the pleasure of the State Surgeon General.
513 The State Surgeon General shall provide guidance to members of
514 the board to ensure that moneys received by the direct-support
515 organization are not received from inappropriate sources.
516 Inappropriate sources include, but are not limited to, donors,
517 grantors, persons, or organizations, or pharmaceutical
518 companies, that may monetarily or substantively benefit from the
519 purchase of goods or services by the department in furtherance
520 of the prescription drug monitoring program.
521 Section 9. Paragraphs (d) and (e) of subsection (3) of
522 section 893.0551, Florida Statutes, are amended to read:
523 893.0551 Public records exemption for the prescription drug
524 monitoring program.—
525 (3) The department shall disclose such confidential and
526 exempt information to the following entities after using a
527 verification process to ensure the legitimacy of that person’s
528 or entity’s request for the information:
529 (d) A health care practitioner or a designated agent under
530 his or her supervision who certifies that the information is
531 necessary to provide medical treatment to a current patient in
532 accordance with ss. 893.05 and 893.055.
533 (e) A pharmacist or a designated agent under his or her
534 supervision who certifies that the requested information will be
535 used to dispense controlled substances to a current patient in
536 accordance with ss. 893.04 and 893.055.
537 Section 10. Section 893.0552, Florida Statutes, is created
538 to read:
539 893.0552 Preemption of regulation.—
540 (1) This section preempts to the state all regulation of
541 the licensure, standards of practice, and operation of pain
542 management clinics as defined in ss. 458.3265 and 459.0137 in
543 the following circumstances:
544 (a) The clinic is wholly owned and operated by a physician
545 who performs interventional pain procedures of the type
546 routinely billed using surgical codes, who has never been
547 suspended or revoked for prescribing a controlled substance in
548 Schedule II or Schedule III of s. 893.03 and drugs containing
549 Alprazolam in excessive or inappropriate quantities that are not
550 in the best interest of a patient, and who:
551 1. Has completed a fellowship in pain medicine which is
552 approved by the Accreditation Council for Graduate Medical
553 Education or the American Osteopathic Association;
554 2. Is board-certified in pain medicine by the American
555 Board of Pain Medicine, board-certified by the American Board of
556 Interventional Pain Physicians; or
557 3. Has a board certification or subcertification in pain
558 management or pain medicine by a specialty board approved by the
559 American Board of Medical Specialties or the American
560 Osteopathic Association.
561 (b) The clinic is wholly owned and operated by a physician
562 multispecialty practice if one or more board-eligible or board
563 certified medical specialists has one of the qualifications
564 specified in subparagraph (a)1., subparagraph (a)2., or
565 subparagraph (a)3., performs interventional pain procedures of
566 the type routinely billed using surgical codes, and has never
567 been suspended or revoked for prescribing a controlled substance
568 in Schedule II or Schedule III of s. 893.03 and drugs containing
569 Alprazolam in excessive or inappropriate quantities that are not
570 in the best interest of a patient.
571 (2) Notwithstanding subsection (1), the preemption does not
572 prohibit a local government or political subdivision from
573 enacting an ordinance regarding local business taxes adopted
574 pursuant to chapter 205, any other local levy, charge, or fee
575 applied to businesses currently authorized by general law or the
576 Florida Constitution, and land use development regulations
577 adopted pursuant to chapter 163. A pain-management clinic in
578 which the regulation of its licensure, standards of practice,
579 and operation is preempted to the state pursuant to subsection
580 (1) is a permissible use in a land use or zoning category that
581 permits hospitals and other health care facilities or clinics as
582 defined in chapter 395 or s. 408.07. Upon the request of a local
583 government, a pain-management clinic must annually demonstrate
584 that it qualifies for preemption pursuant to subsection (1).
585 Section 11. Subsection (1) of section 409.9201, Florida
586 Statutes, is amended to read:
587 409.9201 Medicaid fraud.—
588 (1) As used in this section, the term:
589 (a) “Prescription drug” means any drug, including, but not
590 limited to, finished dosage forms or active ingredients that are
591 subject to, defined by, or described by s. 503(b) of the Federal
592 Food, Drug, and Cosmetic Act or by s. 465.003 s. 465.003(8), s.
593 499.003(46) or (53) or s. 499.007(13).
594 (b) “Value” means the amount billed to the Medicaid program
595 for the property dispensed or the market value of a legend drug
596 or goods or services at the time and place of the offense. If
597 the market value cannot be determined, the term means the
598 replacement cost of the legend drug or goods or services within
599 a reasonable time after the offense.
600
601 The value of individual items of the legend drugs or goods or
602 services involved in distinct transactions committed during a
603 single scheme or course of conduct, whether involving a single
604 person or several persons, may be aggregated when determining
605 the punishment for the offense.
606 Section 12. Paragraph (pp) of subsection (1) of section
607 458.331, Florida Statutes, is amended to read:
608 458.331 Grounds for disciplinary action; action by the
609 board and department.—
610 (1) The following acts constitute grounds for denial of a
611 license or disciplinary action, as specified in s. 456.072(2):
612 (pp) Applicable to a licensee who serves as the designated
613 physician of a pain-management clinic as defined in s. 458.3265
614 or s. 459.0137:
615 1. Registering a pain-management clinic through
616 misrepresentation or fraud;
617 2. Procuring, or attempting to procure, the registration of
618 a pain-management clinic for any other person by making or
619 causing to be made, any false representation;
620 3. Failing to comply with any requirement of chapter 499,
621 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
622 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
623 the Drug Abuse Prevention and Control Act; or chapter 893, the
624 Florida Comprehensive Drug Abuse Prevention and Control Act;
625 4. Being convicted or found guilty of, regardless of
626 adjudication to, a felony or any other crime involving moral
627 turpitude, fraud, dishonesty, or deceit in any jurisdiction of
628 the courts of this state, of any other state, or of the United
629 States;
630 5. Being convicted of, or disciplined by a regulatory
631 agency of the Federal Government or a regulatory agency of
632 another state for, any offense that would constitute a violation
633 of this chapter;
634 6. Being convicted of, or entering a plea of guilty or nolo
635 contendere to, regardless of adjudication, a crime in any
636 jurisdiction of the courts of this state, of any other state, or
637 of the United States which relates to the practice of, or the
638 ability to practice, a licensed health care profession;
639 7. Being convicted of, or entering a plea of guilty or nolo
640 contendere to, regardless of adjudication, a crime in any
641 jurisdiction of the courts of this state, of any other state, or
642 of the United States which relates to health care fraud;
643 8. Dispensing any medicinal drug based upon a communication
644 that purports to be a prescription as defined in s. 465.003 s.
645 465.003(14) or s. 893.02 if the dispensing practitioner knows or
646 has reason to believe that the purported prescription is not
647 based upon a valid practitioner-patient relationship; or
648 9. Failing to timely notify the board of the date of his or
649 her termination from a pain-management clinic as required by s.
650 458.3265(2).
651 Section 13. Paragraph (rr) of subsection (1) of section
652 459.015, Florida Statutes, is amended to read:
653 459.015 Grounds for disciplinary action; action by the
654 board and department.—
655 (1) The following acts constitute grounds for denial of a
656 license or disciplinary action, as specified in s. 456.072(2):
657 (rr) Applicable to a licensee who serves as the designated
658 physician of a pain-management clinic as defined in s. 458.3265
659 or s. 459.0137:
660 1. Registering a pain-management clinic through
661 misrepresentation or fraud;
662 2. Procuring, or attempting to procure, the registration of
663 a pain-management clinic for any other person by making or
664 causing to be made, any false representation;
665 3. Failing to comply with any requirement of chapter 499,
666 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
667 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
668 the Drug Abuse Prevention and Control Act; or chapter 893, the
669 Florida Comprehensive Drug Abuse Prevention and Control Act;
670 4. Being convicted or found guilty of, regardless of
671 adjudication to, a felony or any other crime involving moral
672 turpitude, fraud, dishonesty, or deceit in any jurisdiction of
673 the courts of this state, of any other state, or of the United
674 States;
675 5. Being convicted of, or disciplined by a regulatory
676 agency of the Federal Government or a regulatory agency of
677 another state for, any offense that would constitute a violation
678 of this chapter;
679 6. Being convicted of, or entering a plea of guilty or nolo
680 contendere to, regardless of adjudication, a crime in any
681 jurisdiction of the courts of this state, of any other state, or
682 of the United States which relates to the practice of, or the
683 ability to practice, a licensed health care profession;
684 7. Being convicted of, or entering a plea of guilty or nolo
685 contendere to, regardless of adjudication, a crime in any
686 jurisdiction of the courts of this state, of any other state, or
687 of the United States which relates to health care fraud;
688 8. Dispensing any medicinal drug based upon a communication
689 that purports to be a prescription as defined in s. 465.003 s.
690 465.003(14) or s. 893.02 if the dispensing practitioner knows or
691 has reason to believe that the purported prescription is not
692 based upon a valid practitioner-patient relationship; or
693 9. Failing to timely notify the board of the date of his or
694 her termination from a pain-management clinic as required by s.
695 459.0137(2).
696 Section 14. Subsection (1) of section 465.014, Florida
697 Statutes, is amended to read:
698 465.014 Pharmacy technician.—
699 (1) A person other than a licensed pharmacist or pharmacy
700 intern may not engage in the practice of the profession of
701 pharmacy, except that a licensed pharmacist may delegate to
702 pharmacy technicians who are registered pursuant to this section
703 those duties, tasks, and functions that do not fall within the
704 purview of s. 465.003 s. 465.003(13). All such delegated acts
705 shall be performed under the direct supervision of a licensed
706 pharmacist who shall be responsible for all such acts performed
707 by persons under his or her supervision. A pharmacy registered
708 technician, under the supervision of a pharmacist, may initiate
709 or receive communications with a practitioner or his or her
710 agent, on behalf of a patient, regarding refill authorization
711 requests. A licensed pharmacist may not supervise more than one
712 registered pharmacy technician unless otherwise permitted by the
713 guidelines adopted by the board. The board shall establish
714 guidelines to be followed by licensees or permittees in
715 determining the circumstances under which a licensed pharmacist
716 may supervise more than one but not more than three pharmacy
717 technicians.
718 Section 15. Paragraph (c) of subsection (2) of section
719 465.015, Florida Statutes, is amended to read:
720 465.015 Violations and penalties.—
721 (2) It is unlawful for any person:
722 (c) To sell or dispense drugs as defined in s. 465.003 s.
723 465.003(8) without first being furnished with a prescription.
724 Section 16. Subsection (8) of section 465.0156, Florida
725 Statutes, is amended to read:
726 465.0156 Registration of nonresident pharmacies.—
727 (8) Notwithstanding s. 465.003 s. 465.003(10), for purposes
728 of this section, the registered pharmacy and the pharmacist
729 designated by the registered pharmacy as the prescription
730 department manager or the equivalent must be licensed in the
731 state of location in order to dispense into this state.
732 Section 17. Subsection (4) of section 465.0197, Florida
733 Statutes, is amended to read:
734 465.0197 Internet pharmacy permits.—
735 (4) Notwithstanding s. 465.003 s. 465.003(10), for purposes
736 of this section, the Internet pharmacy and the pharmacist
737 designated by the Internet pharmacy as the prescription
738 department manager or the equivalent must be licensed in the
739 state of location in order to dispense into this state.
740 Section 18. Section 465.1901, Florida Statutes, is amended
741 to read:
742 465.1901 Practice of orthotics and pedorthics.—The
743 provisions of chapter 468 relating to orthotics or pedorthics do
744 not apply to any licensed pharmacist or to any person acting
745 under the supervision of a licensed pharmacist. The practice of
746 orthotics or pedorthics by a pharmacist or any of the
747 pharmacist’s employees acting under the supervision of a
748 pharmacist shall be construed to be within the meaning of the
749 term “practice of the profession of pharmacy” as set forth in s.
750 465.003 s. 465.003(13), and shall be subject to regulation in
751 the same manner as any other pharmacy practice. The Board of
752 Pharmacy shall develop rules regarding the practice of orthotics
753 and pedorthics by a pharmacist. Any pharmacist or person under
754 the supervision of a pharmacist engaged in the practice of
755 orthotics or pedorthics is not precluded from continuing that
756 practice pending adoption of these rules.
757 Section 19. Subsection (43) of section 499.003, Florida
758 Statutes, is amended to read:
759 499.003 Definitions of terms used in this part.—As used in
760 this part, the term:
761 (43) “Prescription drug” means a prescription, medicinal,
762 or legend drug, including, but not limited to, finished dosage
763 forms or active pharmaceutical ingredients subject to, defined
764 by, or described by s. 503(b) of the Federal Food, Drug, and
765 Cosmetic Act or s. 465.003 s. 465.003(8), s. 499.007(13), or
766 subsection (11), subsection (46), or subsection (53), except
767 that an active pharmaceutical ingredient is a prescription drug
768 only if substantially all finished dosage forms in which it may
769 be lawfully dispensed or administered in this state are also
770 prescription drugs.
771 Section 20. Subsection (22) of section 893.02, Florida
772 Statutes, is amended to read:
773 893.02 Definitions.—The following words and phrases as used
774 in this chapter shall have the following meanings, unless the
775 context otherwise requires:
776 (22) “Prescription” means and includes an order for drugs
777 or medicinal supplies written, signed, or transmitted by word of
778 mouth, telephone, telegram, or other means of communication by a
779 duly licensed practitioner licensed by the laws of the state to
780 prescribe such drugs or medicinal supplies, issued in good faith
781 and in the course of professional practice, intended to be
782 filled, compounded, or dispensed by another person licensed by
783 the laws of the state to do so, and meeting the requirements of
784 s. 893.04. The term also includes an order for drugs or
785 medicinal supplies so transmitted or written by a physician,
786 dentist, veterinarian, or other practitioner licensed to
787 practice in a state other than Florida, but only if the
788 pharmacist called upon to fill such an order determines, in the
789 exercise of his or her professional judgment, that the order was
790 issued pursuant to a valid patient-physician relationship, that
791 it is authentic, and that the drugs or medicinal supplies so
792 ordered are considered necessary for the continuation of
793 treatment of a chronic or recurrent illness. However, if the
794 physician writing the prescription is not known to the
795 pharmacist, the pharmacist shall obtain proof to a reasonable
796 certainty of the validity of said prescription. A prescription
797 order for a controlled substance shall not be issued on the same
798 prescription blank with another prescription order for a
799 controlled substance which is named or described in a different
800 schedule, nor shall any prescription order for a controlled
801 substance be issued on the same prescription blank as a
802 prescription order for a medicinal drug, as defined in s.
803 465.003 s. 465.003(8), which does not fall within the definition
804 of a controlled substance as defined in this act.
805 Section 21. This act shall take effect July 1, 2013.