Florida Senate - 2013 CS for SB 1192
By the Committee on Health Policy; and Senator Grimsley
588-02807-13 20131192c1
1 A bill to be entitled
2 An act relating to the provision of health care with
3 controlled substances; creating ss. 400.996 and
4 408.833, F.S.; providing that regulation of the
5 licensure, activity, and operation of clinics and
6 health care facilities is preempted to the state;
7 prohibiting a local government or political
8 subdivision of the state from enacting or enforcing an
9 ordinance that imposes a levy, charge, or fee upon, or
10 that otherwise regulates, clinics and health care
11 facilities, except for ordinances regarding local
12 business taxes and land development; amending s.
13 456.44, F.S.; limiting the application of requirements
14 for prescribing controlled substances; requiring a
15 physician to consult the prescription drug monitoring
16 program database before prescribing certain controlled
17 substances; authorizing the board to adopt a penalty
18 for failure to consult the database; exempting nursing
19 home residents and certain physicians from
20 requirements regarding prescriptions of controlled
21 substances; amending s. 458.326, F.S.; requiring a
22 physician to consult the prescription drug monitoring
23 program database or designate an agent to consult the
24 database before prescribing certain controlled
25 substances; authorizing the board to adopt a penalty
26 for failure to consult the database; amending ss.
27 458.3265 and 459.0137, F.S.; requiring that owners of
28 pain-management clinics be licensed physicians;
29 removing language regarding nonphysician-owned pain
30 management clinics; providing that regulation of the
31 licensure and activity of certain physicians and
32 osteopathic physicians is preempted to the state;
33 prohibiting a local government or political
34 subdivision of the state from enacting or enforcing an
35 ordinance that imposes a levy, charge, or fee upon, or
36 that otherwise regulates, physicians and osteopathic
37 physicians, except for ordinances regarding local
38 business taxes and land development; amending s.
39 465.003, F.S.; defining a term; conforming a cross
40 reference; creating s. 465.0065, F.S.; providing
41 notice requirements for inspection of a pharmacy;
42 amending s. 465.016, F.S.; providing additional
43 grounds for disciplinary action; conforming a cross
44 reference; amending s. 465.022, F.S.; conforming a
45 cross-reference; requiring a pharmacy permittee to
46 commence operations within 180 days after permit
47 issuance or show good cause why operations were not
48 commenced; requiring the board to establish rules;
49 requiring a pharmacy permittee to be supervised by a
50 prescription department manager or consultant
51 pharmacist of record; amending s. 465.023, F.S.;
52 providing additional grounds for disciplinary action;
53 conforming a cross-reference; creating s. 465.1902,
54 F.S.; providing that regulation of the licensure,
55 activity, and operation of pharmacies and pharmacists
56 is preempted to the state; prohibiting a local
57 government or political subdivision of the state from
58 enacting or enforcing an ordinance that imposes a
59 levy, charge, or fee upon, or that otherwise
60 regulates, pharmacies and pharmacists, except for
61 ordinances regarding local business taxes and land
62 development; amending s. 893.055, F.S.; deleting an
63 obsolete provision; authorizing the prescription drug
64 monitoring program to be funded by state funds and
65 pharmaceutical company donations; amending ss.
66 409.9201, 458.331, 459.015, 465.014, 465.015,
67 465.0156, 465.0197, 465.1901, 499.003, and 893.02,
68 F.S.; conforming cross-references; providing an
69 effective date.
70
71 Be It Enacted by the Legislature of the State of Florida:
72
73 Section 1. Section 400.996, Florida Statutes, is created to
74 read:
75 400.996 Preemption.—This chapter preempts to the state all
76 regulation of the licensure, activity, and operation of clinics
77 under part X of chapter 400, excluding registration and
78 licensing for pain-management clinics. A local government or
79 political subdivision of the state may not enact or enforce an
80 ordinance that imposes a levy, charge, or fee upon, or that
81 otherwise regulates, clinics under part X of chapter 400,
82 including services provided within such facilities, except that
83 this preemption does not prohibit a local government or
84 political subdivision from enacting an ordinance regarding the
85 following:
86 (1) Local business taxes adopted pursuant to chapter 205.
87 (2) Land use development regulations adopted pursuant to
88 chapter 163, which include regulation of any aspect of
89 development, including a subdivision, building construction,
90 sign regulation, and any other regulation concerning the
91 development of land, landscaping, or tree protection, and which
92 do not include restrictions on pain-management services, health
93 care services, or the prescribing of controlled substances.
94 However, a clinic that treats pain or provides pain-management
95 services is a permissible use in a land use or zoning category
96 that permits hospitals, other health care facilities, or clinics
97 as defined in chapter 395, s. 408.07, or part X of chapter 400.
98 Section 2. Section 408.833, Florida Statutes, is created to
99 read:
100 408.833 Preemption.—This chapter preempts to the state all
101 regulation of the licensure, activity, and operation of health
102 care facilities as defined in s. 408.07. A local government or
103 political subdivision of the state may not enact or enforce an
104 ordinance that imposes a levy, charge, or fee upon, or that
105 otherwise regulates health care facilities as defined in s.
106 408.07, including services provided within such facilities,
107 except that this preemption does not prohibit a local government
108 or political subdivision from enacting an ordinance regarding
109 the following:
110 (1) Local business taxes adopted pursuant to chapter 205.
111 (2) Land use development regulations adopted pursuant to
112 chapter 163, which include regulation of any aspect of
113 development, including a subdivision, building construction,
114 sign regulation, and any other regulation concerning the
115 development of land, landscaping, or tree protection, and which
116 do not include restrictions on pain-management services, health
117 care services, or the prescribing of controlled substances.
118 However, a health care facility or clinic that treats pain or
119 provides pain-management services is a permissible use in a land
120 use or zoning category that permits hospitals, other health care
121 facilities, or clinics as defined in chapter 395, s. 408.07, or
122 part X of chapter 400.
123 Section 3. Subsections (2) and (3) of section 456.44,
124 Florida Statutes, are amended to read:
125 456.44 Controlled substance prescribing.—
126 (2) REGISTRATION.—Effective January 1, 2012, A physician
127 licensed under chapter 458, chapter 459, chapter 461, or chapter
128 466 who prescribes more than a 30-day supply of any controlled
129 substance, listed in Schedule II, Schedule III, or Schedule IV
130 as defined in s. 893.03, over a 6-month period to any one
131 patient for the treatment of chronic nonmalignant pain, must:
132 (a) Designate himself or herself as a controlled substance
133 prescribing practitioner on the physician’s practitioner
134 profile.
135 (b) Comply with the requirements of this section and
136 applicable board rules.
137 (3) STANDARDS OF PRACTICE.—The standards of practice in
138 this section do not supersede the level of care, skill, and
139 treatment recognized in general law related to health care
140 licensure.
141 (a) A complete medical history and a physical examination
142 must be conducted before beginning any treatment and must be
143 documented in the medical record. The exact components of the
144 physical examination shall be left to the judgment of the
145 clinician who is expected to perform a physical examination
146 proportionate to the diagnosis that justifies a treatment. The
147 medical record must, at a minimum, document the nature and
148 intensity of the pain, current and past treatments for pain,
149 underlying or coexisting diseases or conditions, the effect of
150 the pain on physical and psychological function, a review of
151 previous medical records, previous diagnostic studies, and
152 history of alcohol and substance abuse. The medical record shall
153 also document the presence of one or more recognized medical
154 indications for the use of a controlled substance. Each
155 registrant must develop a written plan for assessing each
156 patient’s risk of aberrant drug-related behavior, which may
157 include patient drug testing. Registrants must assess each
158 patient’s risk for aberrant drug-related behavior and monitor
159 that risk on an ongoing basis in accordance with the plan.
160 (b) Before or during a new patient’s visit for pain
161 treatment services at a pain-management clinic registered under
162 s. 458.3265 or s. 459.0137, a physician shall consult the
163 prescription drug monitoring program database provided under s.
164 893.055(2)(a) before prescribing a controlled substance listed
165 in Schedule II or Schedule III in s. 893.03. The physician may
166 designate an agent under his or her supervision to consult the
167 database. The board shall adopt rules to establish a penalty for
168 a physician who does not comply with this subsection.
169 (c)(b) Each registrant must develop a written
170 individualized treatment plan for each patient. The treatment
171 plan shall state objectives that will be used to determine
172 treatment success, such as pain relief and improved physical and
173 psychosocial function, and shall indicate if any further
174 diagnostic evaluations or other treatments are planned. After
175 treatment begins, the physician shall adjust drug therapy to the
176 individual medical needs of each patient. Other treatment
177 modalities, including a rehabilitation program, shall be
178 considered depending on the etiology of the pain and the extent
179 to which the pain is associated with physical and psychosocial
180 impairment. The interdisciplinary nature of the treatment plan
181 shall be documented.
182 (d)(c) The physician shall discuss the risks and benefits
183 of the use of controlled substances, including the risks of
184 abuse and addiction, as well as physical dependence and its
185 consequences, with the patient, persons designated by the
186 patient, or the patient’s surrogate or guardian if the patient
187 is incompetent. The physician shall use a written controlled
188 substance agreement between the physician and the patient
189 outlining the patient’s responsibilities, including, but not
190 limited to:
191 1. Number and frequency of controlled substance
192 prescriptions and refills.
193 2. Patient compliance and reasons for which drug therapy
194 may be discontinued, such as a violation of the agreement.
195 3. An agreement that controlled substances for the
196 treatment of chronic nonmalignant pain shall be prescribed by a
197 single treating physician unless otherwise authorized by the
198 treating physician and documented in the medical record.
199 (e)(d) The patient shall be seen by the physician at
200 regular intervals, not to exceed 3 months, to assess the
201 efficacy of treatment, ensure that controlled substance therapy
202 remains indicated, evaluate the patient’s progress toward
203 treatment objectives, consider adverse drug effects, and review
204 the etiology of the pain. Continuation or modification of
205 therapy shall depend on the physician’s evaluation of the
206 patient’s progress. If treatment goals are not being achieved,
207 despite medication adjustments, the physician shall reevaluate
208 the appropriateness of continued treatment. The physician shall
209 monitor patient compliance in medication usage, related
210 treatment plans, controlled substance agreements, and
211 indications of substance abuse or diversion at a minimum of 3
212 month intervals.
213 (f)(e) The physician shall refer the patient as necessary
214 for additional evaluation and treatment in order to achieve
215 treatment objectives. Special attention shall be given to those
216 patients who are at risk for misusing their medications and
217 those whose living arrangements pose a risk for medication
218 misuse or diversion. The management of pain in patients with a
219 history of substance abuse or with a comorbid psychiatric
220 disorder requires extra care, monitoring, and documentation and
221 requires consultation with or referral to an addiction medicine
222 specialist or psychiatrist.
223 (g)(f) A physician registered under this section must
224 maintain accurate, current, and complete records that are
225 accessible and readily available for review and comply with the
226 requirements of this section, the applicable practice act, and
227 applicable board rules. The medical records must include, but
228 are not limited to:
229 1. The complete medical history and a physical examination,
230 including history of drug abuse or dependence.
231 2. Diagnostic, therapeutic, and laboratory results.
232 3. Evaluations and consultations.
233 4. Treatment objectives.
234 5. Discussion of risks and benefits.
235 6. Treatments.
236 7. Medications, including date, type, dosage, and quantity
237 prescribed.
238 8. Instructions and agreements.
239 9. Periodic reviews.
240 10. Results of any drug testing.
241 11. A photocopy of the patient’s government-issued photo
242 identification.
243 12. If a written prescription for a controlled substance is
244 given to the patient, a duplicate of the prescription.
245 13. The physician’s full name presented in a legible
246 manner.
247 (h)(g) Patients with signs or symptoms of substance abuse
248 shall be immediately referred to a board-certified pain
249 management physician, an addiction medicine specialist, or a
250 mental health addiction facility as it pertains to drug abuse or
251 addiction unless the physician is board-certified or board
252 eligible in pain management. Throughout the period of time
253 before receiving the consultant’s report, a prescribing
254 physician shall clearly and completely document medical
255 justification for continued treatment with controlled substances
256 and those steps taken to ensure medically appropriate use of
257 controlled substances by the patient. Upon receipt of the
258 consultant’s written report, the prescribing physician shall
259 incorporate the consultant’s recommendations for continuing,
260 modifying, or discontinuing controlled substance therapy. The
261 resulting changes in treatment shall be specifically documented
262 in the patient’s medical record. Evidence or behavioral
263 indications of diversion shall be followed by discontinuation of
264 controlled substance therapy, and the patient shall be
265 discharged, and all results of testing and actions taken by the
266 physician shall be documented in the patient’s medical record.
267
268 This subsection does not apply to a board-eligible or board
269 certified anesthesiologist, physiatrist, rheumatologist, or
270 neurologist, or to a board-certified physician who has surgical
271 privileges at a hospital or ambulatory surgery center and
272 primarily provides surgical services. This subsection does not
273 apply to a board-eligible or board-certified medical specialist
274 who has also completed a fellowship in pain medicine approved by
275 the Accreditation Council for Graduate Medical Education or the
276 American Osteopathic Association, or who is board eligible or
277 board certified in pain medicine by the American Board of Pain
278 Medicine or a board approved by the American Board of Medical
279 Specialties or the American Osteopathic Association and performs
280 interventional pain procedures of the type routinely billed
281 using surgical codes. This subsection does not apply to a
282 physician who prescribes medically necessary controlled
283 substances for a patient during an inpatient stay in a hospital
284 licensed under chapter 395 or to a resident in a facility
285 licensed under part II of chapter 400. This subsection does not
286 apply to any physician licensed under chapter 458 or chapter 459
287 who writes fewer than 50 prescriptions for a controlled
288 substance for all of his or her patients during a 1-year period.
289 Section 4. Subsection (3) of section 458.326, Florida
290 Statutes, is amended to read:
291 458.326 Intractable pain; authorized treatment.—
292 (3)(a) Notwithstanding any other provision of law, a
293 physician may prescribe or administer any controlled substance
294 under Schedules II-V, as provided for in s. 893.03, to a person
295 for the treatment of intractable pain, provided the physician
296 does so in accordance with that level of care, skill, and
297 treatment recognized by a reasonably prudent physician under
298 similar conditions and circumstances.
299 (b) Before or during a new patient’s visit for pain
300 treatment services, a physician shall consult the prescription
301 drug monitoring program database provided under s. 893.055(2)(a)
302 before prescribing a controlled substance listed in Schedule II
303 or Schedule III in s. 893.03. The physician may designate an
304 agent under his or her supervision to consult the database. The
305 board shall adopt rules to establish a penalty for a physician
306 who does not comply with this paragraph.
307 Section 5. Paragraphs (a) and (d) of subsection (1) of
308 section 458.3265, Florida Statutes, are amended, present
309 subsections (5) and (6) of that section are renumbered as
310 subsections (6) and (7), respectively, and a new subsection (5)
311 is added to that section, to read:
312 458.3265 Pain-management clinics.—
313 (1) REGISTRATION.—
314 (a)1. As used in this section, the term:
315 a. “Board eligible” means successful completion of an
316 anesthesia, physical medicine and rehabilitation, rheumatology,
317 or neurology residency program approved by the Accreditation
318 Council for Graduate Medical Education or the American
319 Osteopathic Association for a period of 6 years from successful
320 completion of such residency program.
321 b. “Chronic nonmalignant pain” means pain unrelated to
322 cancer which persists beyond the usual course of disease or the
323 injury that is the cause of the pain or more than 90 days after
324 surgery.
325 c. “Pain-management clinic” or “clinic” means any publicly
326 or privately owned facility:
327 (I) That advertises in any medium for any type of pain
328 management services; or
329 (II) Where in any month a majority of patients are
330 prescribed opioids, benzodiazepines, barbiturates, or
331 carisoprodol for the treatment of chronic nonmalignant pain.
332 2. Each pain-management clinic must register with the
333 department unless:
334 a. That clinic is licensed as a facility pursuant to
335 chapter 395;
336 b. The majority of the physicians who provide services in
337 the clinic primarily provide surgical services;
338 c. The clinic is owned by a publicly held corporation whose
339 shares are traded on a national exchange or on the over-the
340 counter market and whose total assets at the end of the
341 corporation’s most recent fiscal quarter exceeded $50 million;
342 c.d. The clinic is affiliated with an accredited medical
343 school at which training is provided for medical students,
344 residents, or fellows;
345 d.e. The clinic does not prescribe controlled substances
346 for the treatment of pain;
347 f. The clinic is owned by a corporate entity exempt from
348 federal taxation under 26 U.S.C. s. 501(c)(3);
349 e.g. The clinic is wholly owned and operated by one or more
350 board-eligible or board-certified anesthesiologists,
351 physiatrists, rheumatologists, or neurologists; or
352 f.h. The clinic is wholly owned and operated by a physician
353 multispecialty practice where one or more board-eligible or
354 board-certified medical specialists who have also completed
355 fellowships in pain medicine approved by the Accreditation
356 Council for Graduate Medical Education, or who are also board
357 certified in pain medicine by the American Board of Pain
358 Medicine or a board approved by the American Board of Medical
359 Specialties, the American Association of Physician Specialists,
360 or the American Osteopathic Association and perform
361 interventional pain procedures of the type routinely billed
362 using surgical codes.
363 (d) The department shall deny registration to any clinic
364 that is not fully owned by a physician licensed under this
365 chapter or chapter 459 or a group of physicians, each of whom is
366 licensed under this chapter or chapter 459; or that is not a
367 health care clinic licensed under part X of chapter 400 which is
368 fully owned by such physician or group of physicians.
369 (5) PREEMPTION.—This chapter preempts to the state all
370 regulation of the licensure and activity of a physician licensed
371 under this chapter who owns, operates, or works in a pain
372 management clinic or provides pain-management services. A local
373 government or political subdivision of the state may not enact
374 or enforce an ordinance that imposes a levy, charge, or fee
375 upon, or that otherwise regulates, a physician licensed under
376 this chapter who owns, operates, or works in a pain-management
377 clinic or provides pain-management services, except that this
378 preemption does not prohibit a local government or political
379 subdivision from enacting an ordinance regarding the following:
380 (a) A registered pain-management clinic as defined in
381 subsection (1).
382 (b) Local business taxes adopted pursuant to chapter 205.
383 (c) Land use development regulations adopted pursuant to
384 chapter 163, which include regulation of any aspect of
385 development, including a subdivision, building construction,
386 sign regulation, and any other regulation concerning the
387 development of land, landscaping, or tree protection, and which
388 do not include restrictions on pain-management services, health
389 care services, or the prescribing of controlled substances.
390 However, a health care facility or clinic that treats pain or
391 provides pain-management services is a permissible use in a land
392 use or zoning category that permits hospitals, other health care
393 facilities, or clinics as defined in chapter 395, s. 408.07, or
394 part X of chapter 400.
395 Section 6. Paragraphs (a) and (d) of subsection (1) of
396 section 459.0137, Florida Statutes, are amended, present
397 subsections (5) and (6) of that section are renumbered as
398 subsections (6) and (7), respectively, and a new subsection (5)
399 is added to that section, to read:
400 459.0137 Pain-management clinics.—
401 (1) REGISTRATION.—
402 (a)1. As used in this section, the term:
403 a. “Board eligible” means successful completion of an
404 anesthesia, physical medicine and rehabilitation, rheumatology,
405 or neurology residency program approved by the Accreditation
406 Council for Graduate Medical Education or the American
407 Osteopathic Association for a period of 6 years from successful
408 completion of such residency program.
409 b. “Chronic nonmalignant pain” means pain unrelated to
410 cancer which persists beyond the usual course of disease or the
411 injury that is the cause of the pain or more than 90 days after
412 surgery.
413 c. “Pain-management clinic” or “clinic” means any publicly
414 or privately owned facility:
415 (I) That advertises in any medium for any type of pain
416 management services; or
417 (II) Where in any month a majority of patients are
418 prescribed opioids, benzodiazepines, barbiturates, or
419 carisoprodol for the treatment of chronic nonmalignant pain.
420 2. Each pain-management clinic must register with the
421 department unless:
422 a. That clinic is licensed as a facility pursuant to
423 chapter 395;
424 b. The majority of the physicians who provide services in
425 the clinic primarily provide surgical services;
426 c. The clinic is owned by a publicly held corporation whose
427 shares are traded on a national exchange or on the over-the
428 counter market and whose total assets at the end of the
429 corporation’s most recent fiscal quarter exceeded $50 million;
430 c.d. The clinic is affiliated with an accredited medical
431 school at which training is provided for medical students,
432 residents, or fellows;
433 d.e. The clinic does not prescribe controlled substances
434 for the treatment of pain;
435 f. The clinic is owned by a corporate entity exempt from
436 federal taxation under 26 U.S.C. s. 501(c)(3);
437 e.g. The clinic is wholly owned and operated by one or more
438 board-eligible or board-certified anesthesiologists,
439 physiatrists, rheumatologists, or neurologists; or
440 f.h. The clinic is wholly owned and operated by a physician
441 multispecialty practice where one or more board-eligible or
442 board-certified medical specialists who have also completed
443 fellowships in pain medicine approved by the Accreditation
444 Council for Graduate Medical Education or the American
445 Osteopathic Association, or who are also board-certified in pain
446 medicine by the American Board of Pain Medicine or a board
447 approved by the American Board of Medical Specialties, the
448 American Association of Physician Specialists, or the American
449 Osteopathic Association and perform interventional pain
450 procedures of the type routinely billed using surgical codes.
451 (d) The department shall deny registration to any clinic
452 that is not fully owned by a physician licensed under chapter
453 458 or this chapter or a group of physicians, each of whom is
454 licensed under chapter 458 or this chapter; or that is not a
455 health care clinic licensed under part X of chapter 400 which is
456 fully owned by such physician or group of physicians.
457 (5) PREEMPTION.—This chapter preempts to the state all
458 regulation of the licensure and activity of an osteopathic
459 physician licensed under this chapter who owns, operates, or
460 works in a pain-management clinic or provides pain-management
461 services. A local government or political subdivision of the
462 state may not enact or enforce an ordinance that imposes a levy,
463 charge, or fee upon, or that otherwise regulates, an osteopathic
464 physician licensed under this chapter who owns, operates, or
465 works in a pain-management clinic, except that this preemption
466 does not prohibit a local government or political subdivision
467 from enacting an ordinance regarding the following:
468 (a) A registered pain-management clinic as defined in
469 subsection (1).
470 (b) Local business taxes adopted pursuant to chapter 205.
471 (c) Land use development regulations adopted pursuant to
472 chapter 163, which include regulation of any aspect of
473 development, including a subdivision, building construction,
474 sign regulation, and any other regulation concerning the
475 development of land, landscaping, or tree protection, and which
476 do not include restrictions on pain-management services, health
477 care services, and the prescribing of controlled substances.
478 However, a health care facility or clinic that treats pain or
479 provides pain-management services is a permissible use in a land
480 use or zoning category that permits hospitals, other health care
481 facilities, or clinics as defined in chapter 395, s. 408.07, or
482 part X of chapter 400.
483 Section 7. Present subsections (1) through (17) of section
484 465.003, Florida Statutes, are renumbered as subsections (2)
485 through (18), respectively, paragraph (a) of present subsection
486 (11) of that section is amended, and a new subsection (1) is
487 added to that section, to read:
488 465.003 Definitions.—As used in this chapter, the term:
489 (1) “Abandoned” means the status of a pharmacy permit of a
490 person or entity that was issued the permit but fails to
491 commence pharmacy operations within 180 days after issuance of
492 the permit without good cause or fails to follow pharmacy
493 closure requirements as set by the board.
494 (12)(11)(a) “Pharmacy” includes a community pharmacy, an
495 institutional pharmacy, a nuclear pharmacy, a special pharmacy,
496 and an Internet pharmacy.
497 1. The term “community pharmacy” includes every location
498 where medicinal drugs are compounded, dispensed, stored, or sold
499 or where prescriptions are filled or dispensed on an outpatient
500 basis.
501 2. The term “institutional pharmacy” includes every
502 location in a hospital, clinic, nursing home, dispensary,
503 sanitarium, extended care facility, or other facility,
504 hereinafter referred to as “health care institutions,” where
505 medicinal drugs are compounded, dispensed, stored, or sold.
506 3. The term “nuclear pharmacy” includes every location
507 where radioactive drugs and chemicals within the classification
508 of medicinal drugs are compounded, dispensed, stored, or sold.
509 The term “nuclear pharmacy” does not include hospitals licensed
510 under chapter 395 or the nuclear medicine facilities of such
511 hospitals.
512 4. The term “special pharmacy” includes every location
513 where medicinal drugs are compounded, dispensed, stored, or sold
514 if such locations are not otherwise defined in this subsection.
515 5. The term “Internet pharmacy” includes locations not
516 otherwise licensed or issued a permit under this chapter, within
517 or outside this state, which use the Internet to communicate
518 with or obtain information from consumers in this state and use
519 such communication or information to fill or refill
520 prescriptions or to dispense, distribute, or otherwise engage in
521 the practice of pharmacy in this state. Any act described in
522 this definition constitutes the practice of pharmacy as defined
523 in subsection (14)(13).
524 Section 8. Section 465.0065, Florida Statutes, is created
525 to read:
526 465.0065 Notices; form and service.—Each notice served by
527 the department pursuant to this chapter must be in writing and
528 must be delivered personally by an agent of the department or by
529 certified mail to the pharmacy permittee or licensee. If the
530 pharmacy permittee or licensee refuses to accept service or
531 evades service or if the agent is otherwise unable to carry out
532 service after due diligence, the department may post the notice
533 in a conspicuous place at the pharmacy or at the home or
534 business address for the licensee.
535 Section 9. Paragraphs (e) and (s) of subsection (1) of
536 section 465.016, Florida Statutes, are amended, and paragraph
537 (u) is added to that subsection to read:
538 465.016 Disciplinary actions.—
539 (1) The following acts constitute grounds for denial of a
540 license or disciplinary action, as specified in s. 456.072(2):
541 (e) Violating chapter 499; 21 U.S.C. ss. 301-392, known as
542 the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et
543 seq., known as the Comprehensive Drug Abuse Prevention and
544 Control Act; or chapter 893 or rules adopted thereunder.
545 (s) Dispensing any medicinal drug based upon a
546 communication that purports to be a prescription as defined by
547 s. 465.003 s. 465.003(14) or s. 893.02 when the pharmacist knows
548 or has reason to believe that the purported prescription is not
549 based upon a valid practitioner-patient relationship.
550 (u) Misappropriating drugs, supplies, or equipment from a
551 pharmacy permittee.
552 Section 10. Paragraph (j) of subsection (5) of section
553 465.022, Florida Statutes, is amended, present subsections (10)
554 through (14) are renumbered as subsections (11) through (15),
555 respectively, present subsection (10) of that section is
556 amended, and a new subsection (10) is added to that section, to
557 read:
558 465.022 Pharmacies; general requirements; fees.—
559 (5) The department or board shall deny an application for a
560 pharmacy permit if the applicant or an affiliated person,
561 partner, officer, director, or prescription department manager
562 or consultant pharmacist of record of the applicant:
563 (j) Has dispensed any medicinal drug based upon a
564 communication that purports to be a prescription as defined by
565 s. 465.003 s. 465.003(14) or s. 893.02 when the pharmacist knows
566 or has reason to believe that the purported prescription is not
567 based upon a valid practitioner-patient relationship that
568 includes a documented patient evaluation, including history and
569 a physical examination adequate to establish the diagnosis for
570 which any drug is prescribed and any other requirement
571 established by board rule under chapter 458, chapter 459,
572 chapter 461, chapter 463, chapter 464, or chapter 466.
573
574 For felonies in which the defendant entered a plea of guilty or
575 nolo contendere in an agreement with the court to enter a
576 pretrial intervention or drug diversion program, the department
577 shall deny the application if upon final resolution of the case
578 the licensee has failed to successfully complete the program.
579 (10) The permittee shall commence pharmacy operations
580 within 180 days after issuance of the permit, or show good cause
581 to the department why pharmacy operations were not commenced.
582 Commencement of pharmacy operations includes, but is not limited
583 to, acts within the scope of the practice of pharmacy, ordering
584 or receiving drugs, and other similar activities. The board
585 shall establish rules regarding commencement of pharmacy
586 operations.
587 (11)(10) A pharmacy permittee shall be supervised by a
588 prescription department manager or consultant pharmacist of
589 record at all times. A permittee must notify the department, on
590 a form approved by the board, within 10 days after any change in
591 prescription department manager or consultant pharmacist of
592 record.
593 Section 11. Subsection (1) of section 465.023, Florida
594 Statutes, is amended to read:
595 465.023 Pharmacy permittee; disciplinary action.—
596 (1) The department or the board may revoke or suspend the
597 permit of any pharmacy permittee, and may fine, place on
598 probation, or otherwise discipline any pharmacy permittee if the
599 permittee, or any affiliated person, partner, officer, director,
600 or agent of the permittee, including a person fingerprinted
601 under s. 465.022(3), has:
602 (a) Obtained a permit by misrepresentation or fraud or
603 through an error of the department or the board;
604 (b) Attempted to procure, or has procured, a permit for any
605 other person by making, or causing to be made, any false
606 representation;
607 (c) Violated any of the requirements of this chapter or any
608 of the rules of the Board of Pharmacy; of chapter 499, known as
609 the “Florida Drug and Cosmetic Act”; of 21 U.S.C. ss. 301-392,
610 known as the “Federal Food, Drug, and Cosmetic Act”; of 21
611 U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse
612 Prevention and Control Act; or of chapter 893 or rules adopted
613 thereunder;
614 (d) Been convicted or found guilty, regardless of
615 adjudication, of a felony or any other crime involving moral
616 turpitude in any of the courts of this state, of any other
617 state, or of the United States;
618 (e) Been convicted or disciplined by a regulatory agency of
619 the Federal Government or a regulatory agency of another state
620 for any offense that would constitute a violation of this
621 chapter;
622 (f) Been convicted of, or entered a plea of guilty or nolo
623 contendere to, regardless of adjudication, a crime in any
624 jurisdiction which relates to the practice of, or the ability to
625 practice, the profession of pharmacy;
626 (g) Been convicted of, or entered a plea of guilty or nolo
627 contendere to, regardless of adjudication, a crime in any
628 jurisdiction which relates to health care fraud; or
629 (h) Dispensed any medicinal drug based upon a communication
630 that purports to be a prescription as defined by s. 465.003 s.
631 465.003(14) or s. 893.02 when the pharmacist knows or has reason
632 to believe that the purported prescription is not based upon a
633 valid practitioner-patient relationship that includes a
634 documented patient evaluation, including history and a physical
635 examination adequate to establish the diagnosis for which any
636 drug is prescribed and any other requirement established by
637 board rule under chapter 458, chapter 459, chapter 461, chapter
638 463, chapter 464, or chapter 466.
639 Section 12. Section 465.1902, Florida Statutes, is created
640 to read:
641 465.1902 Preemption.—This chapter preempts to the state all
642 regulation of the licensure, activity, and operation of
643 pharmacies and pharmacists as defined in this chapter. A local
644 government or political subdivision of the state may not enact
645 or enforce an ordinance that imposes a levy, charge, or fee
646 upon, or that otherwise regulates, pharmacies and pharmacists as
647 defined in this chapter, except that this preemption does not
648 prohibit a local government or political subdivision from
649 enacting an ordinance regarding the following:
650 (1) Local business taxes adopted pursuant to chapter 205.
651 (2) Land use development regulations adopted pursuant to
652 chapter 163, which include regulation of any aspect of
653 development, including a subdivision, building construction,
654 sign regulation, and any other regulation concerning the
655 development of land, landscaping, or tree protection, and which
656 do not include restrictions on pain-management services, health
657 care services, or the prescribing of controlled substances.
658 Section 13. Paragraph (b) of subsection (2), subsection
659 (10), and paragraph (c) of subsection (11) of section 893.055,
660 Florida Statutes, are amended to read:
661 893.055 Prescription drug monitoring program.—
662 (2)
663 (b) The department, when the direct support organization
664 receives at least $20,000 in nonstate moneys or the state
665 receives at least $20,000 in federal grants for the prescription
666 drug monitoring program, shall adopt rules as necessary
667 concerning the reporting, accessing the database, evaluation,
668 management, development, implementation, operation, security,
669 and storage of information within the system, including rules
670 for when patient advisory reports are provided to pharmacies and
671 prescribers. The patient advisory report shall be provided in
672 accordance with s. 893.13(7)(a)8. The department shall work with
673 the professional health care licensure boards, such as the Board
674 of Medicine, the Board of Osteopathic Medicine, and the Board of
675 Pharmacy; other appropriate organizations, such as the Florida
676 Pharmacy Association, the Florida Medical Association, the
677 Florida Retail Federation, and the Florida Osteopathic Medical
678 Association, including those relating to pain management; and
679 the Attorney General, the Department of Law Enforcement, and the
680 Agency for Health Care Administration to develop rules
681 appropriate for the prescription drug monitoring program.
682 (10) All costs incurred by the department in administering
683 the prescription drug monitoring program shall be funded through
684 state funds, federal grants, or private funding applied for or
685 received by the state. The department may not commit funds for
686 the monitoring program without ensuring funding is available.
687 The prescription drug monitoring program and the implementation
688 thereof are contingent upon receipt of the nonstate funding. The
689 department and state government shall cooperate with the direct
690 support organization established pursuant to subsection (11) in
691 seeking state funds, federal grant funds, other nonstate grant
692 funds, gifts, donations, or other private moneys for the
693 department if so long as the costs of doing so are not
694 considered material. Nonmaterial costs for this purpose include,
695 but are not limited to, the costs of mailing and personnel
696 assigned to research or apply for a grant. Notwithstanding the
697 exemptions to competitive-solicitation requirements under s.
698 287.057(3)(f), the department shall comply with the competitive
699 solicitation requirements under s. 287.057 for the procurement
700 of any goods or services required by this section. Funds
701 provided, directly or indirectly, by prescription drug
702 manufacturers may not be used to implement the program.
703 (11) The department may establish a direct-support
704 organization that has a board consisting of at least five
705 members to provide assistance, funding, and promotional support
706 for the activities authorized for the prescription drug
707 monitoring program.
708 (c) The State Surgeon General shall appoint a board of
709 directors for the direct-support organization. Members of the
710 board shall serve at the pleasure of the State Surgeon General.
711 The State Surgeon General shall provide guidance to members of
712 the board to ensure that moneys received by the direct-support
713 organization are not received from inappropriate sources.
714 Inappropriate sources include, but are not limited to, donors,
715 grantors, persons, and or organizations, excluding
716 pharmaceutical companies, that may monetarily or substantively
717 benefit from the purchase of goods or services by the department
718 in furtherance of the prescription drug monitoring program.
719 Section 14. Subsection (1) of section 409.9201, Florida
720 Statutes, is amended to read:
721 409.9201 Medicaid fraud.—
722 (1) As used in this section, the term:
723 (a) “Prescription drug” means any drug, including, but not
724 limited to, finished dosage forms or active ingredients that are
725 subject to, defined by, or described by s. 503(b) of the Federal
726 Food, Drug, and Cosmetic Act or by s. 465.003 s. 465.003(8), s.
727 499.003(46) or (53) or s. 499.007(13).
728 (b) “Value” means the amount billed to the Medicaid program
729 for the property dispensed or the market value of a legend drug
730 or goods or services at the time and place of the offense. If
731 the market value cannot be determined, the term means the
732 replacement cost of the legend drug or goods or services within
733 a reasonable time after the offense.
734
735 The value of individual items of the legend drugs or goods or
736 services involved in distinct transactions committed during a
737 single scheme or course of conduct, whether involving a single
738 person or several persons, may be aggregated when determining
739 the punishment for the offense.
740 Section 15. Paragraph (pp) of subsection (1) of section
741 458.331, Florida Statutes, is amended to read:
742 458.331 Grounds for disciplinary action; action by the
743 board and department.—
744 (1) The following acts constitute grounds for denial of a
745 license or disciplinary action, as specified in s. 456.072(2):
746 (pp) Applicable to a licensee who serves as the designated
747 physician of a pain-management clinic as defined in s. 458.3265
748 or s. 459.0137:
749 1. Registering a pain-management clinic through
750 misrepresentation or fraud;
751 2. Procuring, or attempting to procure, the registration of
752 a pain-management clinic for any other person by making or
753 causing to be made, any false representation;
754 3. Failing to comply with any requirement of chapter 499,
755 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
756 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
757 the Drug Abuse Prevention and Control Act; or chapter 893, the
758 Florida Comprehensive Drug Abuse Prevention and Control Act;
759 4. Being convicted or found guilty of, regardless of
760 adjudication to, a felony or any other crime involving moral
761 turpitude, fraud, dishonesty, or deceit in any jurisdiction of
762 the courts of this state, of any other state, or of the United
763 States;
764 5. Being convicted of, or disciplined by a regulatory
765 agency of the Federal Government or a regulatory agency of
766 another state for, any offense that would constitute a violation
767 of this chapter;
768 6. Being convicted of, or entering a plea of guilty or nolo
769 contendere to, regardless of adjudication, a crime in any
770 jurisdiction of the courts of this state, of any other state, or
771 of the United States which relates to the practice of, or the
772 ability to practice, a licensed health care profession;
773 7. Being convicted of, or entering a plea of guilty or nolo
774 contendere to, regardless of adjudication, a crime in any
775 jurisdiction of the courts of this state, of any other state, or
776 of the United States which relates to health care fraud;
777 8. Dispensing any medicinal drug based upon a communication
778 that purports to be a prescription as defined in s. 465.003 s.
779 465.003(14) or s. 893.02 if the dispensing practitioner knows or
780 has reason to believe that the purported prescription is not
781 based upon a valid practitioner-patient relationship; or
782 9. Failing to timely notify the board of the date of his or
783 her termination from a pain-management clinic as required by s.
784 458.3265(2).
785 Section 16. Paragraph (rr) of subsection (1) of section
786 459.015, Florida Statutes, is amended to read:
787 459.015 Grounds for disciplinary action; action by the
788 board and department.—
789 (1) The following acts constitute grounds for denial of a
790 license or disciplinary action, as specified in s. 456.072(2):
791 (rr) Applicable to a licensee who serves as the designated
792 physician of a pain-management clinic as defined in s. 458.3265
793 or s. 459.0137:
794 1. Registering a pain-management clinic through
795 misrepresentation or fraud;
796 2. Procuring, or attempting to procure, the registration of
797 a pain-management clinic for any other person by making or
798 causing to be made, any false representation;
799 3. Failing to comply with any requirement of chapter 499,
800 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
801 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
802 the Drug Abuse Prevention and Control Act; or chapter 893, the
803 Florida Comprehensive Drug Abuse Prevention and Control Act;
804 4. Being convicted or found guilty of, regardless of
805 adjudication to, a felony or any other crime involving moral
806 turpitude, fraud, dishonesty, or deceit in any jurisdiction of
807 the courts of this state, of any other state, or of the United
808 States;
809 5. Being convicted of, or disciplined by a regulatory
810 agency of the Federal Government or a regulatory agency of
811 another state for, any offense that would constitute a violation
812 of this chapter;
813 6. Being convicted of, or entering a plea of guilty or nolo
814 contendere to, regardless of adjudication, a crime in any
815 jurisdiction of the courts of this state, of any other state, or
816 of the United States which relates to the practice of, or the
817 ability to practice, a licensed health care profession;
818 7. Being convicted of, or entering a plea of guilty or nolo
819 contendere to, regardless of adjudication, a crime in any
820 jurisdiction of the courts of this state, of any other state, or
821 of the United States which relates to health care fraud;
822 8. Dispensing any medicinal drug based upon a communication
823 that purports to be a prescription as defined in s. 465.003 s.
824 465.003(14) or s. 893.02 if the dispensing practitioner knows or
825 has reason to believe that the purported prescription is not
826 based upon a valid practitioner-patient relationship; or
827 9. Failing to timely notify the board of the date of his or
828 her termination from a pain-management clinic as required by s.
829 459.0137(2).
830 Section 17. Subsection (1) of section 465.014, Florida
831 Statutes, is amended to read:
832 465.014 Pharmacy technician.—
833 (1) A person other than a licensed pharmacist or pharmacy
834 intern may not engage in the practice of the profession of
835 pharmacy, except that a licensed pharmacist may delegate to
836 pharmacy technicians who are registered pursuant to this section
837 those duties, tasks, and functions that do not fall within the
838 purview of s. 465.003 s. 465.003(13). All such delegated acts
839 shall be performed under the direct supervision of a licensed
840 pharmacist who shall be responsible for all such acts performed
841 by persons under his or her supervision. A pharmacy registered
842 technician, under the supervision of a pharmacist, may initiate
843 or receive communications with a practitioner or his or her
844 agent, on behalf of a patient, regarding refill authorization
845 requests. A licensed pharmacist may not supervise more than one
846 registered pharmacy technician unless otherwise permitted by the
847 guidelines adopted by the board. The board shall establish
848 guidelines to be followed by licensees or permittees in
849 determining the circumstances under which a licensed pharmacist
850 may supervise more than one but not more than three pharmacy
851 technicians.
852 Section 18. Paragraph (c) of subsection (2) of section
853 465.015, Florida Statutes, is amended to read:
854 465.015 Violations and penalties.—
855 (2) It is unlawful for any person:
856 (c) To sell or dispense drugs as defined in s. 465.003 s.
857 465.003(8) without first being furnished with a prescription.
858 Section 19. Subsection (8) of section 465.0156, Florida
859 Statutes, is amended to read:
860 465.0156 Registration of nonresident pharmacies.—
861 (8) Notwithstanding s. 465.003 s. 465.003(10), for purposes
862 of this section, the registered pharmacy and the pharmacist
863 designated by the registered pharmacy as the prescription
864 department manager or the equivalent must be licensed in the
865 state of location in order to dispense into this state.
866 Section 20. Subsection (4) of section 465.0197, Florida
867 Statutes, is amended to read:
868 465.0197 Internet pharmacy permits.—
869 (4) Notwithstanding s. 465.003 s. 465.003(10), for purposes
870 of this section, the Internet pharmacy and the pharmacist
871 designated by the Internet pharmacy as the prescription
872 department manager or the equivalent must be licensed in the
873 state of location in order to dispense into this state.
874 Section 21. Section 465.1901, Florida Statutes, is amended
875 to read:
876 465.1901 Practice of orthotics and pedorthics.—The
877 provisions of chapter 468 relating to orthotics or pedorthics do
878 not apply to any licensed pharmacist or to any person acting
879 under the supervision of a licensed pharmacist. The practice of
880 orthotics or pedorthics by a pharmacist or any of the
881 pharmacist’s employees acting under the supervision of a
882 pharmacist shall be construed to be within the meaning of the
883 term “practice of the profession of pharmacy” as set forth in s.
884 465.003 s. 465.003(13), and shall be subject to regulation in
885 the same manner as any other pharmacy practice. The Board of
886 Pharmacy shall develop rules regarding the practice of orthotics
887 and pedorthics by a pharmacist. Any pharmacist or person under
888 the supervision of a pharmacist engaged in the practice of
889 orthotics or pedorthics is not precluded from continuing that
890 practice pending adoption of these rules.
891 Section 22. Subsection (43) of section 499.003, Florida
892 Statutes, is amended to read:
893 499.003 Definitions of terms used in this part.—As used in
894 this part, the term:
895 (43) “Prescription drug” means a prescription, medicinal,
896 or legend drug, including, but not limited to, finished dosage
897 forms or active pharmaceutical ingredients subject to, defined
898 by, or described by s. 503(b) of the Federal Food, Drug, and
899 Cosmetic Act or s. 465.003 s. 465.003(8), s. 499.007(13), or
900 subsection (11), subsection (46), or subsection (53), except
901 that an active pharmaceutical ingredient is a prescription drug
902 only if substantially all finished dosage forms in which it may
903 be lawfully dispensed or administered in this state are also
904 prescription drugs.
905 Section 23. Subsection (22) of section 893.02, Florida
906 Statutes, is amended to read:
907 893.02 Definitions.—The following words and phrases as used
908 in this chapter shall have the following meanings, unless the
909 context otherwise requires:
910 (22) “Prescription” means and includes an order for drugs
911 or medicinal supplies written, signed, or transmitted by word of
912 mouth, telephone, telegram, or other means of communication by a
913 duly licensed practitioner licensed by the laws of the state to
914 prescribe such drugs or medicinal supplies, issued in good faith
915 and in the course of professional practice, intended to be
916 filled, compounded, or dispensed by another person licensed by
917 the laws of the state to do so, and meeting the requirements of
918 s. 893.04. The term also includes an order for drugs or
919 medicinal supplies so transmitted or written by a physician,
920 dentist, veterinarian, or other practitioner licensed to
921 practice in a state other than Florida, but only if the
922 pharmacist called upon to fill such an order determines, in the
923 exercise of his or her professional judgment, that the order was
924 issued pursuant to a valid patient-physician relationship, that
925 it is authentic, and that the drugs or medicinal supplies so
926 ordered are considered necessary for the continuation of
927 treatment of a chronic or recurrent illness. However, if the
928 physician writing the prescription is not known to the
929 pharmacist, the pharmacist shall obtain proof to a reasonable
930 certainty of the validity of said prescription. A prescription
931 order for a controlled substance shall not be issued on the same
932 prescription blank with another prescription order for a
933 controlled substance which is named or described in a different
934 schedule, nor shall any prescription order for a controlled
935 substance be issued on the same prescription blank as a
936 prescription order for a medicinal drug, as defined in s.
937 465.003 s. 465.003(8), which does not fall within the definition
938 of a controlled substance as defined in this act.
939 Section 24. This act shall take effect July 1, 2013.