Florida Senate - 2013 CS for CS for CS for SB 1192
By the Committees on Appropriations; Community Affairs; and
Health Policy; and Senator Grimsley
576-04972-13 20131192c3
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 activity, and operation of pain-management clinics is
53 preempted to the state under certain circumstances;
54 authorizing a local government or political
55 subdivision of the state to enact certain ordinances
56 regarding local business taxes and land development;
57 amending ss. 409.9201, 458.331, 459.015, 465.014,
58 465.015, 465.0156, 465.0197, 465.1901, 499.003, and
59 893.02, F.S.; conforming cross-references; providing
60 an effective date.
61
62 Be It Enacted by the Legislature of the State of Florida:
63
64 Section 1. Section 456.44, Florida Statutes, is amended to
65 read:
66 456.44 Controlled substance prescribing.—
67 (1) DEFINITIONS.—
68 (a) “Addiction medicine specialist” means a board-certified
69 psychiatrist with a subspecialty certification in addiction
70 medicine or who is eligible for such subspecialty certification
71 in addiction medicine, an addiction medicine physician certified
72 or eligible for certification by the American Society of
73 Addiction Medicine, or an osteopathic physician who holds a
74 certificate of added qualification in Addiction Medicine through
75 the American Osteopathic Association.
76 (b) “Adverse incident” means any incident set forth in s.
77 458.351(4)(a)-(e) or s. 459.026(4)(a)-(e).
78 (c) “Board-certified pain management physician” means a
79 physician who possesses board certification in pain medicine by
80 the American Board of Pain Medicine, board certification by the
81 American Board of Interventional Pain Physicians, or board
82 certification or subcertification in pain management or pain
83 medicine by a specialty board recognized by the American
84 Association of Physician Specialists or the American Board of
85 Medical Specialties or an osteopathic physician who holds a
86 certificate in Pain Management by the American Osteopathic
87 Association.
88 (d) “Board eligible” means successful completion of an
89 anesthesia, physical medicine and rehabilitation, rheumatology,
90 or neurology residency program approved by the Accreditation
91 Council for Graduate Medical Education or the American
92 Osteopathic Association for a period of 6 years from successful
93 completion of such residency program.
94 (e) “Chronic nonmalignant pain” means pain unrelated to
95 cancer which persists beyond the usual course of disease or the
96 injury that is the cause of the pain or more than 90 days after
97 surgery.
98 (f) “Mental health addiction facility” means a facility
99 licensed under chapter 394 or chapter 397.
100 (2) REGISTRATION.—Effective January 1, 2012, A physician
101 licensed under chapter 458, chapter 459, chapter 461, or chapter
102 466 who prescribes more than a 30-day supply of any controlled
103 substance, listed in Schedule II, Schedule III, or Schedule IV
104 as defined in s. 893.03, over a 6-month period to any one
105 patient for the treatment of chronic nonmalignant pain, must:
106 (a) Designate himself or herself as a controlled substance
107 prescribing practitioner on the physician’s practitioner
108 profile.
109 (b) Comply with the requirements of this section and
110 applicable board rules.
111 (3) STANDARDS OF PRACTICE.—The standards of practice in
112 this section do not supersede the level of care, skill, and
113 treatment recognized in general law related to health care
114 licensure.
115 (a) A complete medical history and a physical examination
116 must be conducted before beginning any treatment and must be
117 documented in the medical record. The exact components of the
118 physical examination shall be left to the judgment of the
119 clinician who is expected to perform a physical examination
120 proportionate to the diagnosis that justifies a treatment. The
121 medical record must, at a minimum, document the nature and
122 intensity of the pain, current and past treatments for pain,
123 underlying or coexisting diseases or conditions, the effect of
124 the pain on physical and psychological function, a review of
125 previous medical records, previous diagnostic studies, and
126 history of alcohol and substance abuse. The medical record shall
127 also document the presence of one or more recognized medical
128 indications for the use of a controlled substance. Each
129 registrant must develop a written plan for assessing each
130 patient’s risk of aberrant drug-related behavior, which may
131 include patient drug testing. Registrants must assess each
132 patient’s risk for aberrant drug-related behavior and monitor
133 that risk on an ongoing basis in accordance with the plan.
134 (b) Before or during a new patient’s visit for services for
135 the treatment of pain at a pain-management clinic registered
136 under s. 458.3265 or s. 459.0137, a physician shall consult the
137 prescription drug monitoring program database provided under s.
138 893.055(2)(a) before prescribing a controlled substance listed
139 in Schedule II or Schedule III in s. 893.03. The physician may
140 designate an agent under his or her supervision to consult the
141 database. The Board of Medicine under chapter 458 and the Board
142 of Osteopathic Medicine under chapter 459 shall adopt rules to
143 establish a penalty for a physician who does not comply with
144 this subsection.
145 (c)(b) Each registrant must develop a written
146 individualized treatment plan for each patient. The treatment
147 plan shall state objectives that will be used to determine
148 treatment success, such as pain relief and improved physical and
149 psychosocial function, and shall indicate if any further
150 diagnostic evaluations or other treatments are planned. After
151 treatment begins, the physician shall adjust drug therapy to the
152 individual medical needs of each patient. Other treatment
153 modalities, including a rehabilitation program, shall be
154 considered depending on the etiology of the pain and the extent
155 to which the pain is associated with physical and psychosocial
156 impairment. The interdisciplinary nature of the treatment plan
157 shall be documented.
158 (d)(c) The physician shall discuss the risks and benefits
159 of the use of controlled substances, including the risks of
160 abuse and addiction, as well as physical dependence and its
161 consequences, with the patient, persons designated by the
162 patient, or the patient’s surrogate or guardian if the patient
163 is incompetent. The physician shall use a written controlled
164 substance agreement between the physician and the patient
165 outlining the patient’s responsibilities, including, but not
166 limited to:
167 1. Number and frequency of controlled substance
168 prescriptions and refills.
169 2. Patient compliance and reasons for which drug therapy
170 may be discontinued, such as a violation of the agreement.
171 3. An agreement that controlled substances for the
172 treatment of chronic nonmalignant pain shall be prescribed by a
173 single treating physician unless otherwise authorized by the
174 treating physician and documented in the medical record.
175 (e)(d) The patient shall be seen by the physician at
176 regular intervals, not to exceed 3 months, to assess the
177 efficacy of treatment, ensure that controlled substance therapy
178 remains indicated, evaluate the patient’s progress toward
179 treatment objectives, consider adverse drug effects, and review
180 the etiology of the pain. Continuation or modification of
181 therapy shall depend on the physician’s evaluation of the
182 patient’s progress. If treatment goals are not being achieved,
183 despite medication adjustments, the physician shall reevaluate
184 the appropriateness of continued treatment. The physician shall
185 monitor patient compliance in medication usage, related
186 treatment plans, controlled substance agreements, and
187 indications of substance abuse or diversion at a minimum of 3
188 month intervals.
189 (f)(e) The physician shall refer the patient as necessary
190 for additional evaluation and treatment in order to achieve
191 treatment objectives. Special attention shall be given to those
192 patients who are at risk for misusing their medications and
193 those whose living arrangements pose a risk for medication
194 misuse or diversion. The management of pain in patients with a
195 history of substance abuse or with a comorbid psychiatric
196 disorder requires extra care, monitoring, and documentation and
197 requires consultation with or referral to an addiction medicine
198 specialist or psychiatrist.
199 (g)(f) A physician registered under this section must
200 maintain accurate, current, and complete records that are
201 accessible and readily available for review and comply with the
202 requirements of this section, the applicable practice act, and
203 applicable board rules. The medical records must include, but
204 are not limited to:
205 1. The complete medical history and a physical examination,
206 including history of drug abuse or dependence.
207 2. Diagnostic, therapeutic, and laboratory results.
208 3. Evaluations and consultations.
209 4. Treatment objectives.
210 5. Discussion of risks and benefits.
211 6. Treatments.
212 7. Medications, including date, type, dosage, and quantity
213 prescribed.
214 8. Instructions and agreements.
215 9. Periodic reviews.
216 10. Results of any drug testing.
217 11. A photocopy of the patient’s government-issued photo
218 identification.
219 12. If a written prescription for a controlled substance is
220 given to the patient, a duplicate of the prescription.
221 13. The physician’s full name presented in a legible
222 manner.
223 (h)(g) Patients with signs or symptoms of substance abuse
224 shall be immediately referred to a board-certified pain
225 management physician, an addiction medicine specialist, or a
226 mental health addiction facility as it pertains to drug abuse or
227 addiction unless the physician is board-certified or board
228 eligible in pain management. Throughout the period of time
229 before receiving the consultant’s report, a prescribing
230 physician shall clearly and completely document medical
231 justification for continued treatment with controlled substances
232 and those steps taken to ensure medically appropriate use of
233 controlled substances by the patient. Upon receipt of the
234 consultant’s written report, the prescribing physician shall
235 incorporate the consultant’s recommendations for continuing,
236 modifying, or discontinuing controlled substance therapy. The
237 resulting changes in treatment shall be specifically documented
238 in the patient’s medical record. Evidence or behavioral
239 indications of diversion shall be followed by discontinuation of
240 controlled substance therapy, and the patient shall be
241 discharged, and all results of testing and actions taken by the
242 physician shall be documented in the patient’s medical record.
243
244 This section subsection does not apply to a board-eligible or
245 board-certified anesthesiologist, physiatrist, rheumatologist,
246 or neurologist, or to a board-certified physician who has
247 surgical privileges at a hospital or ambulatory surgery center
248 and primarily provides surgical services. This section
249 subsection does not apply to a board-eligible or board-certified
250 medical specialist who has also completed a fellowship in pain
251 medicine approved by the Accreditation Council for Graduate
252 Medical Education or the American Osteopathic Association, or
253 who is board eligible or board certified in pain medicine by the
254 American Board of Pain Medicine or a board approved by the
255 American Board of Medical Specialties or the American
256 Osteopathic Association and performs interventional pain
257 procedures of the type routinely billed using surgical codes.
258 This section subsection does not apply to a physician who
259 prescribes medically necessary controlled substances for a
260 patient during an inpatient stay in a hospital licensed under
261 chapter 395 or to a resident in a facility licensed under part
262 II of chapter 400. This section does not apply to a physician
263 licensed under chapter 458 or chapter 459 who writes fewer than
264 50 prescriptions for a controlled substance for all of his or
265 her patients during a 1-year period.
266 Section 2. Present subsections (1) through (17) of section
267 465.003, Florida Statutes, are renumbered as subsections (2)
268 through (18), respectively, paragraph (a) of present subsection
269 (11) of that section is amended, and a new subsection (1) is
270 added to that section, to read:
271 465.003 Definitions.—As used in this chapter, the term:
272 (1) “Abandoned” means the status of a pharmacy permit of a
273 person or entity that was issued the permit but fails to
274 commence pharmacy operations within 180 days after issuance of
275 the permit without good cause or fails to follow pharmacy
276 closure requirements as set by the board.
277 (12)(11)(a) “Pharmacy” includes a community pharmacy, an
278 institutional pharmacy, a nuclear pharmacy, a special pharmacy,
279 and an Internet pharmacy.
280 1. The term “community pharmacy” includes every location
281 where medicinal drugs are compounded, dispensed, stored, or sold
282 or where prescriptions are filled or dispensed on an outpatient
283 basis.
284 2. The term “institutional pharmacy” includes every
285 location in a hospital, clinic, nursing home, dispensary,
286 sanitarium, extended care facility, or other facility,
287 hereinafter referred to as “health care institutions,” where
288 medicinal drugs are compounded, dispensed, stored, or sold.
289 3. The term “nuclear pharmacy” includes every location
290 where radioactive drugs and chemicals within the classification
291 of medicinal drugs are compounded, dispensed, stored, or sold.
292 The term “nuclear pharmacy” does not include hospitals licensed
293 under chapter 395 or the nuclear medicine facilities of such
294 hospitals.
295 4. The term “special pharmacy” includes every location
296 where medicinal drugs are compounded, dispensed, stored, or sold
297 if such locations are not otherwise defined in this subsection.
298 5. The term “Internet pharmacy” includes locations not
299 otherwise licensed or issued a permit under this chapter, within
300 or outside this state, which use the Internet to communicate
301 with or obtain information from consumers in this state and use
302 such communication or information to fill or refill
303 prescriptions or to dispense, distribute, or otherwise engage in
304 the practice of pharmacy in this state. Any act described in
305 this definition constitutes the practice of pharmacy as defined
306 in subsection (14)(13).
307 Section 3. Section 465.0065, Florida Statutes, is created
308 to read:
309 465.0065 Notices; form and service.—Each notice served by
310 the department pursuant to this chapter must be in writing and
311 must be delivered personally by an agent of the department or by
312 certified mail to the pharmacy permittee or licensee. If the
313 pharmacy permittee or licensee refuses to accept service or
314 evades service or if the agent is otherwise unable to carry out
315 service after due diligence, the department may post the notice
316 in a conspicuous place at the pharmacy or at the home or
317 business address for the licensee.
318 Section 4. Paragraphs (e) and (s) of subsection (1) of
319 section 465.016, Florida Statutes, are amended, and paragraph
320 (u) is added to that subsection, to read:
321 465.016 Disciplinary actions.—
322 (1) The following acts constitute grounds for denial of a
323 license or disciplinary action, as specified in s. 456.072(2):
324 (e) Violating chapter 499; 21 U.S.C. ss. 301-392, known as
325 the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et
326 seq., known as the Comprehensive Drug Abuse Prevention and
327 Control Act; or chapter 893 or rules adopted thereunder.
328 (s) Dispensing any medicinal drug based upon a
329 communication that purports to be a prescription as defined by
330 s. 465.003 s. 465.003(14) or s. 893.02 when the pharmacist knows
331 or has reason to believe that the purported prescription is not
332 based upon a valid practitioner-patient relationship.
333 (u) Misappropriating drugs, supplies, or equipment from a
334 pharmacy permittee.
335 Section 5. Paragraph (j) of subsection (5) of section
336 465.022, Florida Statutes, is amended, present subsections (10)
337 through (14) are renumbered as subsections (11) through (15),
338 respectively, present subsection (10) of that section is
339 amended, and a new subsection (10) is added to that section, to
340 read:
341 465.022 Pharmacies; general requirements; fees.—
342 (5) The department or board shall deny an application for a
343 pharmacy permit if the applicant or an affiliated person,
344 partner, officer, director, or prescription department manager
345 or consultant pharmacist of record of the applicant:
346 (j) Has dispensed any medicinal drug based upon a
347 communication that purports to be a prescription as defined by
348 s. 465.003 s. 465.003(14) or s. 893.02 when the pharmacist knows
349 or has reason to believe that the purported prescription is not
350 based upon a valid practitioner-patient relationship that
351 includes a documented patient evaluation, including history and
352 a physical examination adequate to establish the diagnosis for
353 which any drug is prescribed and any other requirement
354 established by board rule under chapter 458, chapter 459,
355 chapter 461, chapter 463, chapter 464, or chapter 466.
356
357 For felonies in which the defendant entered a plea of guilty or
358 nolo contendere in an agreement with the court to enter a
359 pretrial intervention or drug diversion program, the department
360 shall deny the application if upon final resolution of the case
361 the licensee has failed to successfully complete the program.
362 (10) The permittee shall commence pharmacy operations
363 within 180 days after issuance of the permit, or show good cause
364 to the department why pharmacy operations were not commenced.
365 Commencement of pharmacy operations includes, but is not limited
366 to, acts within the scope of the practice of pharmacy, ordering
367 or receiving drugs, and other similar activities. The board
368 shall establish rules regarding commencement of pharmacy
369 operations.
370 (11)(10) A pharmacy permittee shall be supervised by a
371 prescription department manager or consultant pharmacist of
372 record at all times. A permittee must notify the department, on
373 a form approved by the board, within 10 days after any change in
374 prescription department manager or consultant pharmacist of
375 record.
376 Section 6. Subsection (1) of section 465.023, Florida
377 Statutes, is amended to read:
378 465.023 Pharmacy permittee; disciplinary action.—
379 (1) The department or the board may revoke or suspend the
380 permit of any pharmacy permittee, and may fine, place on
381 probation, or otherwise discipline any pharmacy permittee if the
382 permittee, or any affiliated person, partner, officer, director,
383 or agent of the permittee, including a person fingerprinted
384 under s. 465.022(3), has:
385 (a) Obtained a permit by misrepresentation or fraud or
386 through an error of the department or the board;
387 (b) Attempted to procure, or has procured, a permit for any
388 other person by making, or causing to be made, any false
389 representation;
390 (c) Violated any of the requirements of this chapter or any
391 of the rules of the Board of Pharmacy; of chapter 499, known as
392 the “Florida Drug and Cosmetic Act”; of 21 U.S.C. ss. 301-392,
393 known as the “Federal Food, Drug, and Cosmetic Act”; of 21
394 U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse
395 Prevention and Control Act; or of chapter 893 or rules adopted
396 thereunder;
397 (d) Been convicted or found guilty, regardless of
398 adjudication, of a felony or any other crime involving moral
399 turpitude in any of the courts of this state, of any other
400 state, or of the United States;
401 (e) Been convicted or disciplined by a regulatory agency of
402 the Federal Government or a regulatory agency of another state
403 for any offense that would constitute a violation of this
404 chapter;
405 (f) Been convicted of, or entered a plea of guilty or nolo
406 contendere to, regardless of adjudication, a crime in any
407 jurisdiction which relates to the practice of, or the ability to
408 practice, the profession of pharmacy;
409 (g) Been convicted of, or entered a plea of guilty or nolo
410 contendere to, regardless of adjudication, a crime in any
411 jurisdiction which relates to health care fraud; or
412 (h) Dispensed any medicinal drug based upon a communication
413 that purports to be a prescription as defined by s. 465.003 s.
414 465.003(14) or s. 893.02 when the pharmacist knows or has reason
415 to believe that the purported prescription is not based upon a
416 valid practitioner-patient relationship that includes a
417 documented patient evaluation, including history and a physical
418 examination adequate to establish the diagnosis for which any
419 drug is prescribed and any other requirement established by
420 board rule under chapter 458, chapter 459, chapter 461, chapter
421 463, chapter 464, or chapter 466.
422 Section 7. Section 465.1902, Florida Statutes, is created
423 to read:
424 465.1902 Preemption.—The regulation of pharmacies and
425 pharmacists is expressly preempted to the state. No local
426 ordinance, rule, or regulation shall be enacted or remain in
427 effect which regulates or attempts to regulate pharmacies or
428 pharmacists in subject matters regulated under this chapter,
429 including, but not limited to, licensure, discipline, pharmacy
430 permitting, and the dispensing of controlled substances.
431 Section 8. Paragraph (b) of subsection (2), paragraph (b)
432 of subsection (7), subsection (10), and paragraph (c) of
433 subsection (11) of section 893.055, Florida Statutes, are
434 amended to read:
435 893.055 Prescription drug monitoring program.—
436 (2)
437 (b) The department, when the direct support organization
438 receives at least $20,000 in nonstate moneys or the state
439 receives at least $20,000 in federal grants for the prescription
440 drug monitoring program, shall adopt rules as necessary
441 concerning the reporting, accessing the database, evaluation,
442 management, development, implementation, operation, security,
443 and storage of information within the system, including rules
444 for when patient advisory reports are provided to pharmacies and
445 prescribers. The patient advisory report shall be provided in
446 accordance with s. 893.13(7)(a)8. The department shall work with
447 the professional health care licensure boards, such as the Board
448 of Medicine, the Board of Osteopathic Medicine, and the Board of
449 Pharmacy; other appropriate organizations, such as the Florida
450 Pharmacy Association, the Florida Medical Association, the
451 Florida Retail Federation, and the Florida Osteopathic Medical
452 Association, including those relating to pain management; and
453 the Attorney General, the Department of Law Enforcement, and the
454 Agency for Health Care Administration to develop rules
455 appropriate for the prescription drug monitoring program.
456 (7)
457 (b) A pharmacy, prescriber, designated agent under the
458 supervision of a health care practitioner, or dispenser shall
459 have access to information in the prescription drug monitoring
460 program’s database which relates to a patient of that pharmacy,
461 prescriber, or dispenser in a manner established by the
462 department as needed for the purpose of reviewing the patient’s
463 controlled substance prescription history. Other access to the
464 program’s database shall be limited to the program’s manager and
465 to the designated program and support staff, who may act only at
466 the direction of the program manager or, in the absence of the
467 program manager, as authorized. Access by the program manager or
468 such designated staff is for prescription drug program
469 management only or for management of the program’s database and
470 its system in support of the requirements of this section and in
471 furtherance of the prescription drug monitoring program.
472 Confidential and exempt information in the database shall be
473 released only as provided in paragraph (c) and s. 893.0551. The
474 program manager, designated program and support staff who act at
475 the direction of or in the absence of the program manager, and
476 any individual who has similar access regarding the management
477 of the database from the prescription drug monitoring program
478 shall submit fingerprints to the department for background
479 screening. The department shall follow the procedure established
480 by the Department of Law Enforcement to request a statewide
481 criminal history record check and to request that the Department
482 of Law Enforcement forward the fingerprints to the Federal
483 Bureau of Investigation for a national criminal history record
484 check.
485 (10) All costs incurred by the department in administering
486 the prescription drug monitoring program shall be funded through
487 state funds, federal grants, or private funding applied for or
488 received by the state. The department may not commit funds for
489 the monitoring program without ensuring funding is available.
490 The prescription drug monitoring program and the implementation
491 thereof are contingent upon receipt of the nonstate funding. The
492 department and state government shall cooperate with the direct
493 support organization established pursuant to subsection (11) in
494 seeking state funds, federal grant funds, other nonstate grant
495 funds, gifts, donations, or other private moneys for the
496 department if so long as the costs of doing so are not
497 considered material. Nonmaterial costs for this purpose include,
498 but are not limited to, the costs of mailing and personnel
499 assigned to research or apply for a grant. Notwithstanding the
500 exemptions to competitive-solicitation requirements under s.
501 287.057(3)(f), the department shall comply with the competitive
502 solicitation requirements under s. 287.057 for the procurement
503 of any goods or services required by this section. Funds
504 provided, directly or indirectly, by prescription drug
505 manufacturers may not be used to implement the program.
506 (11) The department may establish a direct-support
507 organization that has a board consisting of at least five
508 members to provide assistance, funding, and promotional support
509 for the activities authorized for the prescription drug
510 monitoring program.
511 (c) The State Surgeon General shall appoint a board of
512 directors for the direct-support organization. Members of the
513 board shall serve at the pleasure of the State Surgeon General.
514 The State Surgeon General shall provide guidance to members of
515 the board to ensure that moneys received by the direct-support
516 organization are not received from inappropriate sources.
517 Inappropriate sources include, but are not limited to, donors,
518 grantors, persons, or organizations, or pharmaceutical
519 companies, that may monetarily or substantively benefit from the
520 purchase of goods or services by the department in furtherance
521 of the prescription drug monitoring program.
522 Section 9. Paragraphs (d) and (e) of subsection (3) of
523 section 893.0551, Florida Statutes, are amended to read:
524 893.0551 Public records exemption for the prescription drug
525 monitoring program.—
526 (3) The department shall disclose such confidential and
527 exempt information to the following entities after using a
528 verification process to ensure the legitimacy of that person’s
529 or entity’s request for the information:
530 (d) A health care practitioner or a designated agent under
531 his or her supervision who certifies that the information is
532 necessary to provide medical treatment to a current patient in
533 accordance with ss. 893.05 and 893.055.
534 (e) A pharmacist or a designated agent under his or her
535 supervision who certifies that the requested information will be
536 used to dispense controlled substances to a current patient in
537 accordance with ss. 893.04 and 893.055.
538 Section 10. Section 893.0552, Florida Statutes, is created
539 to read:
540 893.0552 Preemption of regulation.—
541 (1) This section preempts to the state all regulation of
542 the licensure, activity, and operation of pain-management
543 clinics as defined in ss. 458.3265 and 459.0137 in the following
544 circumstances:
545 (a) The clinic is wholly owned and operated by a physician
546 who performs interventional pain procedures of the type
547 routinely billed using surgical codes, who has never been
548 suspended or revoked for prescribing a controlled substance in
549 Schedule II or Schedule III of s. 893.03 and drugs containing
550 Alprazolam in excessive or inappropriate quantities that are not
551 in the best interest of a patient, and who:
552 1. Has completed a fellowship in pain medicine which is
553 approved by the Accreditation Council for Graduate Medical
554 Education or the American Osteopathic Association;
555 2. Is board-certified in pain medicine by the American
556 Board of Pain Medicine, board-certified by the American Board of
557 Interventional Pain Physicians; or
558 3. Has a board certification or subcertification in pain
559 management or pain medicine by a specialty board approved by the
560 American Board of Medical Specialties or the American
561 Osteopathic Association.
562 (b) The clinic is wholly owned and operated by a physician
563 multispecialty practice if one or more board-eligible or board
564 certified medical specialists has one of the qualifications
565 specified in subparagraph (a)1., subparagraph (a)2., or
566 subparagraph (a)3., performs interventional pain procedures of
567 the type routinely billed using surgical codes, and has never
568 been suspended or revoked for prescribing a controlled substance
569 in Schedule II or Schedule III of s. 893.03 and drugs containing
570 Alprazolam in excessive or inappropriate quantities that are not
571 in the best interest of a patient.
572 (2) Notwithstanding subsection (1), the preemption does not
573 prohibit a local government or political subdivision from
574 enacting an ordinance regarding local business taxes adopted
575 pursuant to chapter 205 and land use development regulations
576 adopted pursuant to chapter 163. A pain-management clinic in
577 which the regulation of its licensure, activity, and operation
578 is preempted to the state pursuant to subsection (1) is a
579 permissible use in a land use or zoning category that permits
580 hospitals and other health care facilities or clinics as defined
581 in chapter 395 or s. 408.07. Upon the request of a local
582 government, a pain-management clinic must annually demonstrate
583 that it qualifies for preemption pursuant to subsection (1).
584 Section 11. Subsection (1) of section 409.9201, Florida
585 Statutes, is amended to read:
586 409.9201 Medicaid fraud.—
587 (1) As used in this section, the term:
588 (a) “Prescription drug” means any drug, including, but not
589 limited to, finished dosage forms or active ingredients that are
590 subject to, defined by, or described by s. 503(b) of the Federal
591 Food, Drug, and Cosmetic Act or by s. 465.003 s. 465.003(8), s.
592 499.003(46) or (53) or s. 499.007(13).
593 (b) “Value” means the amount billed to the Medicaid program
594 for the property dispensed or the market value of a legend drug
595 or goods or services at the time and place of the offense. If
596 the market value cannot be determined, the term means the
597 replacement cost of the legend drug or goods or services within
598 a reasonable time after the offense.
599
600 The value of individual items of the legend drugs or goods or
601 services involved in distinct transactions committed during a
602 single scheme or course of conduct, whether involving a single
603 person or several persons, may be aggregated when determining
604 the punishment for the offense.
605 Section 12. Paragraph (pp) of subsection (1) of section
606 458.331, Florida Statutes, is amended to read:
607 458.331 Grounds for disciplinary action; action by the
608 board and department.—
609 (1) The following acts constitute grounds for denial of a
610 license or disciplinary action, as specified in s. 456.072(2):
611 (pp) Applicable to a licensee who serves as the designated
612 physician of a pain-management clinic as defined in s. 458.3265
613 or s. 459.0137:
614 1. Registering a pain-management clinic through
615 misrepresentation or fraud;
616 2. Procuring, or attempting to procure, the registration of
617 a pain-management clinic for any other person by making or
618 causing to be made, any false representation;
619 3. Failing to comply with any requirement of chapter 499,
620 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
621 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
622 the Drug Abuse Prevention and Control Act; or chapter 893, the
623 Florida Comprehensive Drug Abuse Prevention and Control Act;
624 4. Being convicted or found guilty of, regardless of
625 adjudication to, a felony or any other crime involving moral
626 turpitude, fraud, dishonesty, or deceit in any jurisdiction of
627 the courts of this state, of any other state, or of the United
628 States;
629 5. Being convicted of, or disciplined by a regulatory
630 agency of the Federal Government or a regulatory agency of
631 another state for, any offense that would constitute a violation
632 of this chapter;
633 6. Being convicted of, or entering a plea of guilty or nolo
634 contendere to, regardless of adjudication, a crime in any
635 jurisdiction of the courts of this state, of any other state, or
636 of the United States which relates to the practice of, or the
637 ability to practice, a licensed health care profession;
638 7. Being convicted of, or entering a plea of guilty or nolo
639 contendere to, regardless of adjudication, a crime in any
640 jurisdiction of the courts of this state, of any other state, or
641 of the United States which relates to health care fraud;
642 8. Dispensing any medicinal drug based upon a communication
643 that purports to be a prescription as defined in s. 465.003 s.
644 465.003(14) or s. 893.02 if the dispensing practitioner knows or
645 has reason to believe that the purported prescription is not
646 based upon a valid practitioner-patient relationship; or
647 9. Failing to timely notify the board of the date of his or
648 her termination from a pain-management clinic as required by s.
649 458.3265(2).
650 Section 13. Paragraph (rr) of subsection (1) of section
651 459.015, Florida Statutes, is amended to read:
652 459.015 Grounds for disciplinary action; action by the
653 board and department.—
654 (1) The following acts constitute grounds for denial of a
655 license or disciplinary action, as specified in s. 456.072(2):
656 (rr) Applicable to a licensee who serves as the designated
657 physician of a pain-management clinic as defined in s. 458.3265
658 or s. 459.0137:
659 1. Registering a pain-management clinic through
660 misrepresentation or fraud;
661 2. Procuring, or attempting to procure, the registration of
662 a pain-management clinic for any other person by making or
663 causing to be made, any false representation;
664 3. Failing to comply with any requirement of chapter 499,
665 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
666 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
667 the Drug Abuse Prevention and Control Act; or chapter 893, the
668 Florida Comprehensive Drug Abuse Prevention and Control Act;
669 4. Being convicted or found guilty of, regardless of
670 adjudication to, a felony or any other crime involving moral
671 turpitude, fraud, dishonesty, or deceit in any jurisdiction of
672 the courts of this state, of any other state, or of the United
673 States;
674 5. Being convicted of, or disciplined by a regulatory
675 agency of the Federal Government or a regulatory agency of
676 another state for, any offense that would constitute a violation
677 of this chapter;
678 6. Being convicted of, or entering a plea of guilty or nolo
679 contendere to, regardless of adjudication, a crime in any
680 jurisdiction of the courts of this state, of any other state, or
681 of the United States which relates to the practice of, or the
682 ability to practice, a licensed health care profession;
683 7. Being convicted of, or entering a plea of guilty or nolo
684 contendere to, regardless of adjudication, a crime in any
685 jurisdiction of the courts of this state, of any other state, or
686 of the United States which relates to health care fraud;
687 8. Dispensing any medicinal drug based upon a communication
688 that purports to be a prescription as defined in s. 465.003 s.
689 465.003(14) or s. 893.02 if the dispensing practitioner knows or
690 has reason to believe that the purported prescription is not
691 based upon a valid practitioner-patient relationship; or
692 9. Failing to timely notify the board of the date of his or
693 her termination from a pain-management clinic as required by s.
694 459.0137(2).
695 Section 14. Subsection (1) of section 465.014, Florida
696 Statutes, is amended to read:
697 465.014 Pharmacy technician.—
698 (1) A person other than a licensed pharmacist or pharmacy
699 intern may not engage in the practice of the profession of
700 pharmacy, except that a licensed pharmacist may delegate to
701 pharmacy technicians who are registered pursuant to this section
702 those duties, tasks, and functions that do not fall within the
703 purview of s. 465.003 s. 465.003(13). All such delegated acts
704 shall be performed under the direct supervision of a licensed
705 pharmacist who shall be responsible for all such acts performed
706 by persons under his or her supervision. A pharmacy registered
707 technician, under the supervision of a pharmacist, may initiate
708 or receive communications with a practitioner or his or her
709 agent, on behalf of a patient, regarding refill authorization
710 requests. A licensed pharmacist may not supervise more than one
711 registered pharmacy technician unless otherwise permitted by the
712 guidelines adopted by the board. The board shall establish
713 guidelines to be followed by licensees or permittees in
714 determining the circumstances under which a licensed pharmacist
715 may supervise more than one but not more than three pharmacy
716 technicians.
717 Section 15. Paragraph (c) of subsection (2) of section
718 465.015, Florida Statutes, is amended to read:
719 465.015 Violations and penalties.—
720 (2) It is unlawful for any person:
721 (c) To sell or dispense drugs as defined in s. 465.003 s.
722 465.003(8) without first being furnished with a prescription.
723 Section 16. Subsection (8) of section 465.0156, Florida
724 Statutes, is amended to read:
725 465.0156 Registration of nonresident pharmacies.—
726 (8) Notwithstanding s. 465.003 s. 465.003(10), for purposes
727 of this section, the registered pharmacy and the pharmacist
728 designated by the registered pharmacy as the prescription
729 department manager or the equivalent must be licensed in the
730 state of location in order to dispense into this state.
731 Section 17. Subsection (4) of section 465.0197, Florida
732 Statutes, is amended to read:
733 465.0197 Internet pharmacy permits.—
734 (4) Notwithstanding s. 465.003 s. 465.003(10), for purposes
735 of this section, the Internet pharmacy and the pharmacist
736 designated by the Internet pharmacy as the prescription
737 department manager or the equivalent must be licensed in the
738 state of location in order to dispense into this state.
739 Section 18. Section 465.1901, Florida Statutes, is amended
740 to read:
741 465.1901 Practice of orthotics and pedorthics.—The
742 provisions of chapter 468 relating to orthotics or pedorthics do
743 not apply to any licensed pharmacist or to any person acting
744 under the supervision of a licensed pharmacist. The practice of
745 orthotics or pedorthics by a pharmacist or any of the
746 pharmacist’s employees acting under the supervision of a
747 pharmacist shall be construed to be within the meaning of the
748 term “practice of the profession of pharmacy” as set forth in s.
749 465.003 s. 465.003(13), and shall be subject to regulation in
750 the same manner as any other pharmacy practice. The Board of
751 Pharmacy shall develop rules regarding the practice of orthotics
752 and pedorthics by a pharmacist. Any pharmacist or person under
753 the supervision of a pharmacist engaged in the practice of
754 orthotics or pedorthics is not precluded from continuing that
755 practice pending adoption of these rules.
756 Section 19. Subsection (43) of section 499.003, Florida
757 Statutes, is amended to read:
758 499.003 Definitions of terms used in this part.—As used in
759 this part, the term:
760 (43) “Prescription drug” means a prescription, medicinal,
761 or legend drug, including, but not limited to, finished dosage
762 forms or active pharmaceutical ingredients subject to, defined
763 by, or described by s. 503(b) of the Federal Food, Drug, and
764 Cosmetic Act or s. 465.003 s. 465.003(8), s. 499.007(13), or
765 subsection (11), subsection (46), or subsection (53), except
766 that an active pharmaceutical ingredient is a prescription drug
767 only if substantially all finished dosage forms in which it may
768 be lawfully dispensed or administered in this state are also
769 prescription drugs.
770 Section 20. Subsection (22) of section 893.02, Florida
771 Statutes, is amended to read:
772 893.02 Definitions.—The following words and phrases as used
773 in this chapter shall have the following meanings, unless the
774 context otherwise requires:
775 (22) “Prescription” means and includes an order for drugs
776 or medicinal supplies written, signed, or transmitted by word of
777 mouth, telephone, telegram, or other means of communication by a
778 duly licensed practitioner licensed by the laws of the state to
779 prescribe such drugs or medicinal supplies, issued in good faith
780 and in the course of professional practice, intended to be
781 filled, compounded, or dispensed by another person licensed by
782 the laws of the state to do so, and meeting the requirements of
783 s. 893.04. The term also includes an order for drugs or
784 medicinal supplies so transmitted or written by a physician,
785 dentist, veterinarian, or other practitioner licensed to
786 practice in a state other than Florida, but only if the
787 pharmacist called upon to fill such an order determines, in the
788 exercise of his or her professional judgment, that the order was
789 issued pursuant to a valid patient-physician relationship, that
790 it is authentic, and that the drugs or medicinal supplies so
791 ordered are considered necessary for the continuation of
792 treatment of a chronic or recurrent illness. However, if the
793 physician writing the prescription is not known to the
794 pharmacist, the pharmacist shall obtain proof to a reasonable
795 certainty of the validity of said prescription. A prescription
796 order for a controlled substance shall not be issued on the same
797 prescription blank with another prescription order for a
798 controlled substance which is named or described in a different
799 schedule, nor shall any prescription order for a controlled
800 substance be issued on the same prescription blank as a
801 prescription order for a medicinal drug, as defined in s.
802 465.003 s. 465.003(8), which does not fall within the definition
803 of a controlled substance as defined in this act.
804 Section 21. This act shall take effect July 1, 2013.