Florida Senate - 2011 CS for SB 818
By the Committee on Health Regulation; and Senator Fasano
588-02461B-11 2011818c1
1 A bill to be entitled
2 An act relating to controlled substances; amending s.
3 400.9905, F.S.; redefining the terms “clinic” and
4 “portable equipment provider” within the Health Care
5 Clinic Act; amending s. 456.013, F.S.; authorizing
6 certain health care practitioners to complete a
7 continuing education course relating to the
8 prescription drug monitoring program; providing
9 requirements for the course; requiring the Department
10 of Health or a board that is authorized to exercise
11 regulatory or rulemaking functions within the
12 department to approve the course offered through a
13 facility licensed under ch. 395, F.S., under certain
14 circumstances; providing for application of the course
15 requirements; requiring a board or the Department of
16 Health to adopt rules; amending s. 458.305, F.S.;
17 defining the term “dispensing physician” as it relates
18 to the practice of medicine in this state; prohibiting
19 certain persons from using titles or displaying signs
20 that would lead the public to believe that they engage
21 in the dispensing of controlled substances;
22 prohibiting certain persons, firms, or corporations
23 from using a trade name, sign, letter, or
24 advertisement that implies that the persons, firms, or
25 corporations are licensed or registered to dispense
26 prescription drugs; prohibiting certain persons,
27 firms, or corporations from holding themselves out to
28 the public as licensed or registered to dispense
29 controlled substances; providing penalties; amending
30 s. 458.3191, F.S.; revising the information in the
31 physician survey that is submitted by persons who
32 apply for licensure renewal as a physician under ch.
33 458 or ch. 459, F.S.; amending s. 458.3192, F.S.;
34 requiring the Department of Health to provide
35 nonidentifying information to the prescription drug
36 monitoring program’s Implementation and Oversight Task
37 Force regarding the number of physicians that are
38 registered with the prescription drug monitoring
39 program and that use the database from the program in
40 their practice; amending s. 458.3265, F.S.; revising
41 the list of entities that are not required to register
42 as a pain-management clinic; deleting certain
43 requirements for a physician to practice medicine in a
44 pain-management clinic; requiring a physician, an
45 advanced registered nurse practitioner, or a physician
46 assistant to perform an appropriate medical
47 examination of a patient on the same day that the
48 physician dispenses or prescribes a controlled
49 substance to the patient at a pain-management clinic;
50 requiring a physician who works in a pain-management
51 clinic to document the reason a prescription for a
52 certain dosage of a controlled substance is within the
53 proper standard of care; creating a felony of the
54 third degree for any person to register or attempt to
55 register a pain-management clinic through
56 misrepresentation or fraud; amending s. 458.327, F.S.;
57 providing additional penalties; amending s. 458.331,
58 F.S.; providing additional grounds for disciplinary
59 action by the Board of Medicine; amending s. 459.003,
60 F.S.; defining the term “dispensing physician” as it
61 relates to the practice of osteopathic medicine in
62 this state; amending s. 459.013, F.S.; providing
63 additional penalties; amending s. 459.0137, F.S.;
64 providing an exemption from the requirement that all
65 privately owned pain-management clinics, facilities,
66 or offices that advertise in any medium for any type
67 of pain-management services, or employ an osteopathic
68 physician who is primarily engaged in the treatment of
69 pain by prescribing or dispensing controlled substance
70 medications, must register with the Department of
71 Health; requiring a physician, an advanced registered
72 nurse practitioner, or a physician assistant to
73 perform an appropriate medical examination of a
74 patient on the same day that the physician dispenses
75 or prescribes a controlled substance to the patient at
76 a pain-management clinic; requiring an osteopathic
77 physician who works in a pain-management clinic to
78 document the reason a prescription for a certain
79 dosage of a controlled substance is within the proper
80 standard of care; creating a felony of the third
81 degree for a licensee or other person who serves as
82 the designated physician of a pain-management clinic
83 to register a pain-management clinic through
84 misrepresentation or fraud; amending s. 459.015, F.S.;
85 providing additional grounds for disciplinary action
86 by the Board of Osteopathic Medicine; amending s.
87 465.015, F.S.; prohibiting certain persons from
88 knowingly failing to report to the local county
89 sheriff’s office the commission of a felony involving
90 a person who acquires or obtains possession of a
91 controlled substance by misrepresentation, fraud,
92 forgery, deception, or subterfuge under certain
93 conditions; providing penalties; providing
94 requirements for reporting the commission of a felony
95 that involves a person who acquires or obtains
96 possession of a controlled substance by
97 misrepresentation, fraud, forgery, deception, or
98 subterfuge; providing that a pharmacist, pharmacy
99 intern, or other person employed by or at a pharmacy
100 is not subject to disciplinary action for reporting;
101 amending s. 465.0276, F.S.; requiring a practitioner
102 to register as a dispensing practitioner in order to
103 dispense controlled substances; amending s. 766.101,
104 F.S.; conforming a cross-reference; amending s.
105 810.02, F.S.; redefining the offense of burglary to
106 include the theft of a controlled substance within a
107 structure or conveyance; amending s. 812.014, F.S.;
108 redefining the offense of theft to include the theft
109 of a controlled substance; creating s. 893.021, F.S.;
110 providing conditions in which a drug is considered
111 adulterated; providing that a physician is not
112 prevented from directing or prescribing a change to
113 the recognized manufactured recommendations for use of
114 any controlled substance for a patient under certain
115 circumstances; requiring a prescribing physician to
116 indicate on the original prescription any deviation of
117 the recognized manufacturer’s recommended use of a
118 controlled substance; requiring a pharmacist or
119 physician to indicate such deviation on the label of
120 the prescription upon dispensing; amending s. 893.04,
121 F.S.; revising the required information that must
122 appear on the face of a prescription or written record
123 of a controlled substance before it is dispensed by a
124 pharmacist; amending s. 893.055, F.S.; requiring that
125 the prescription drug monitoring program comply with
126 the minimum requirements of the National All Schedules
127 Prescription Electronic Reporting Act; requiring the
128 Department of Health to establish a method to allow
129 corrections to the database of the prescription drug
130 monitoring program; requiring the number of refills
131 ordered and whether the drug was dispensed as a refill
132 or a first-time request to be included in the database
133 of the prescription drug monitoring program; revising
134 the number of days in which a dispensed controlled
135 substance must be reported to the department through
136 the prescription drug monitoring program; revising the
137 list of acts of dispensing or administering which are
138 exempt from reporting; requiring a pharmacy,
139 prescriber, practitioner, or dispenser to register
140 with the department by submitting a registering
141 document in order to have access to certain
142 information in the prescription drug monitoring
143 program’s database; requiring the department to
144 approve the registering document before granting
145 access to information in the prescription drug
146 monitoring program’s database; requiring criminal
147 background screening for those persons who have direct
148 access to the prescription drug monitoring program’s
149 database; authorizing the Attorney General to obtain
150 confidential and exempt information for Medicaid fraud
151 cases and Medicaid investigations; requiring certain
152 documentation to be provided to the program manager in
153 order to release confidential and exempt information
154 from the prescription drug monitoring program’s
155 database to a patient, legal guardian, or a designated
156 health care surrogate; authorizing the Agency for
157 Health Care Administration to obtain confidential and
158 exempt information from the prescription drug
159 monitoring program’s database for Medicaid fraud cases
160 and Medicaid investigations involving controlled
161 substances; deleting a provision requiring that
162 administrative costs of the prescription drug
163 monitoring program be funded through federal grants
164 and private sources; requiring the State Surgeon
165 General to enter into reciprocal agreements for the
166 sharing of information in the prescription drug
167 monitoring program with other states that have a
168 similar prescription drug monitoring program;
169 requiring the State Surgeon General to annually review
170 a reciprocal agreement to determine its compatibility;
171 providing requirements for compatibility; prohibiting
172 the sharing of certain information; amending s.
173 893.0551, F.S.; authorizing the Department of Health
174 to disclose certain confidential and exempt
175 information in the prescription drug monitoring
176 program’s database under certain circumstances
177 involving reciprocal agreements with other states;
178 prohibiting the sharing of information from the
179 prescription drug monitoring program’s database which
180 is not for the purpose that is statutorily authorized
181 or according to the State Surgeon General’s
182 determination of compatibility; amending s. 893.07,
183 F.S.; requiring that a person report to the local
184 sheriff’s office the theft or loss of a controlled
185 substance within a specified time; providing
186 penalties; providing legislative intent; amending s.
187 893.13, F.S.; prohibiting a person from obtaining or
188 attempting to obtain from a practitioner a controlled
189 substance or a prescription for a controlled substance
190 by misrepresentation, fraud, forgery, deception,
191 subterfuge, or concealment of a material fact;
192 prohibiting a health care provider from providing a
193 controlled substance or a prescription for a
194 controlled substance by misrepresentation, fraud,
195 forgery, deception, subterfuge, or concealment of a
196 material fact; prohibiting a person from adulterating
197 a controlled substance for certain use without
198 authorization by a prescribing physician; authorizing
199 a law enforcement officer to seize as evidence the
200 adulteration or off-label use of a prescribed
201 controlled substance; providing that such adulterated
202 or off-label use of the controlled substance may be
203 returned to its owner only under certain conditions;
204 providing penalties; prohibiting a prescribing
205 practitioner from writing a prescription for a
206 controlled substance and authorizing or directing the
207 adulteration of the dispensed form of the controlled
208 substance for the purpose of ingestion by means not
209 medically necessary; amending s. 893.138, F.S.;
210 providing circumstances in which a pain-management
211 clinic may be declared a public nuisance; providing
212 definitions; requiring the Board of Pharmacy to create
213 a list of opioid analgesic drugs; providing
214 requirements for the list of opioid analgesic drugs;
215 prohibiting a pharmacist from interchanging or
216 substituting an opioid analgesic drug, brand, or
217 generic for an opioid analgesic drug incorporating a
218 tamper-resistance technology unless certain
219 requirements are met; providing an effective date.
220
221 Be It Enacted by the Legislature of the State of Florida:
222
223 Section 1. Subsections (4) and (7) of section 400.9905,
224 Florida Statutes, are amended to read:
225 400.9905 Definitions.—
226 (4) “Clinic” means an entity at which health care services
227 are provided to individuals and which tenders charges for
228 reimbursement or payment for such services, including a mobile
229 clinic and a portable equipment provider. For purposes of this
230 part, the term does not include and the licensure requirements
231 of this part do not apply to:
232 (a) Entities licensed or registered by the state under
233 chapter 395; or entities licensed or registered by the state and
234 providing only health care services within the scope of services
235 authorized under their respective licenses granted under ss.
236 383.30-383.335, chapter 390, chapter 394, chapter 397, this
237 chapter except part X, chapter 429, chapter 463, chapter 465,
238 chapter 466, chapter 478, part I of chapter 483, chapter 484, or
239 chapter 651; end-stage renal disease providers authorized under
240 42 C.F.R. part 405, subpart U; or providers certified under 42
241 C.F.R. part 485, subpart B or subpart H; or any entity that
242 provides neonatal or pediatric hospital-based health care
243 services or other health care services by licensed practitioners
244 solely within a hospital licensed under chapter 395.
245 (b) Entities that own, directly or indirectly, entities
246 licensed or registered by the state pursuant to chapter 395; or
247 entities that own, directly or indirectly, entities licensed or
248 registered by the state and providing only health care services
249 within the scope of services authorized pursuant to their
250 respective licenses granted under ss. 383.30-383.335, chapter
251 390, chapter 394, chapter 397, this chapter except part X,
252 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
253 part I of chapter 483, chapter 484, chapter 651; end-stage renal
254 disease providers authorized under 42 C.F.R. part 405, subpart
255 U; or providers certified under 42 C.F.R. part 485, subpart B or
256 subpart H; or any entity that provides neonatal or pediatric
257 hospital-based health care services by licensed practitioners
258 solely within a hospital licensed under chapter 395.
259 (c) Entities that are owned, directly or indirectly, by an
260 entity licensed or registered by the state pursuant to chapter
261 395; or entities that are owned, directly or indirectly, by an
262 entity licensed or registered by the state and providing only
263 health care services within the scope of services authorized
264 pursuant to their respective licenses granted under ss. 383.30
265 383.335, chapter 390, chapter 394, chapter 397, this chapter
266 except part X, chapter 429, chapter 463, chapter 465, chapter
267 466, chapter 478, part I of chapter 483, chapter 484, or chapter
268 651; end-stage renal disease providers authorized under 42
269 C.F.R. part 405, subpart U; or providers certified under 42
270 C.F.R. part 485, subpart B or subpart H; or any entity that
271 provides neonatal or pediatric hospital-based health care
272 services by licensed practitioners solely within a hospital
273 under chapter 395.
274 (d) Entities that are under common ownership, directly or
275 indirectly, with an entity licensed or registered by the state
276 pursuant to chapter 395; or entities that are under common
277 ownership, directly or indirectly, with an entity licensed or
278 registered by the state and providing only health care services
279 within the scope of services authorized pursuant to their
280 respective licenses granted under ss. 383.30-383.335, chapter
281 390, chapter 394, chapter 397, this chapter except part X,
282 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
283 part I of chapter 483, chapter 484, or chapter 651; end-stage
284 renal disease providers authorized under 42 C.F.R. part 405,
285 subpart U; or providers certified under 42 C.F.R. part 485,
286 subpart B or subpart H; or any entity that provides neonatal or
287 pediatric hospital-based health care services by licensed
288 practitioners solely within a hospital licensed under chapter
289 395.
290 (e) An entity that is exempt from federal taxation under 26
291 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan
292 under 26 U.S.C. s. 409 that has a board of trustees not less
293 than two-thirds of which are Florida-licensed health care
294 practitioners and provides only physical therapy services under
295 physician orders, any community college or university clinic,
296 and any entity owned or operated by the federal or state
297 government, including agencies, subdivisions, or municipalities
298 thereof.
299 (f) A sole proprietorship, group practice, partnership, or
300 corporation that provides health care services by physicians
301 covered by s. 627.419, that is directly supervised by one or
302 more of such physicians, and that is wholly owned by one or more
303 of those physicians or by a physician and the spouse, parent,
304 child, or sibling of that physician.
305 (g) A sole proprietorship, group practice, partnership, or
306 corporation that provides health care services by licensed
307 health care practitioners under chapter 457, chapter 458,
308 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
309 chapter 466, chapter 467, chapter 480, chapter 484, chapter 486,
310 chapter 490, chapter 491, or part I, part III, part X, part
311 XIII, or part XIV of chapter 468, or s. 464.012, which are
312 wholly owned by one or more licensed health care practitioners,
313 or the licensed health care practitioners set forth in this
314 paragraph and the spouse, parent, child, or sibling of a
315 licensed health care practitioner, so long as one of the owners
316 who is a licensed health care practitioner is supervising the
317 business activities and is legally responsible for the entity’s
318 compliance with all federal and state laws. However, a health
319 care practitioner may not supervise services beyond the scope of
320 the practitioner’s license, except that, for the purposes of
321 this part, a clinic owned by a licensee in s. 456.053(3)(b) that
322 provides only services authorized pursuant to s. 456.053(3)(b)
323 may be supervised by a licensee specified in s. 456.053(3)(b).
324 (h) Clinical facilities affiliated with an accredited
325 medical school at which training is provided for medical
326 students, residents, or fellows.
327 (i) Entities that provide only oncology or radiation
328 therapy services by physicians licensed under chapter 458 or
329 chapter 459 or entities that provide oncology or radiation
330 therapy services by physicians licensed under chapter 458 or
331 chapter 459 which are owned by a corporation whose shares are
332 publicly traded on a recognized stock exchange.
333 (j) Clinical facilities affiliated with a college of
334 chiropractic accredited by the Council on Chiropractic Education
335 at which training is provided for chiropractic students.
336 (k) Entities that provide licensed practitioners to staff
337 emergency departments or to deliver anesthesia services in
338 facilities licensed under chapter 395 and that derive at least
339 90 percent of their gross annual revenues from the provision of
340 such services. Entities claiming an exemption from licensure
341 under this paragraph must provide documentation demonstrating
342 compliance.
343 (l) Orthotic or prosthetic clinical facilities that are a
344 publicly traded corporation or that are wholly owned, directly
345 or indirectly, by a publicly traded corporation. As used in this
346 paragraph, a publicly traded corporation is a corporation that
347 issues securities traded on an exchange registered with the
348 United States Securities and Exchange Commission as a national
349 securities exchange.
350 (7) “Portable equipment provider” means an entity that
351 contracts with or employs persons to provide portable equipment
352 to multiple locations performing treatment or diagnostic testing
353 of individuals, that bills third-party payors for those
354 services, and that otherwise meets the definition of a clinic in
355 subsection (4).
356 Section 2. Subsection (7) of section 456.013, Florida
357 Statutes, is amended to read:
358 456.013 Department; general licensing provisions.—
359 (7)(a) The boards, or the department when there is no
360 board, shall require the completion of a 2-hour course relating
361 to prevention of medical errors as part of the licensure and
362 renewal process. The 2-hour course counts shall count towards
363 the total number of continuing education hours required for the
364 profession. The board or department shall approve the course
365 shall be approved by the board or department, as appropriate,
366 which must and shall include a study of root-cause analysis,
367 error reduction and prevention, and patient safety. In addition,
368 the course approved by the Board of Medicine and the Board of
369 Osteopathic Medicine must shall include information relating to
370 the five most misdiagnosed conditions during the previous
371 biennium, as determined by the board. If the course is being
372 offered by a facility licensed under pursuant to chapter 395 for
373 its employees, the board may approve up to 1 hour of the 2-hour
374 course to be specifically related to error reduction and
375 prevention methods used in that facility.
376 (b) As a condition of initial licensure and at each
377 subsequent license renewal, the boards, or the department if
378 there is no board, shall allow each practitioner licensed under
379 chapter 458, chapter 459, chapter 461, chapter 465, or chapter
380 466 whose lawful scope of practice authorizes the practitioner
381 to prescribe, administer, or dispense controlled substances to
382 complete a 1-hour continuing education course relating to the
383 prescription drug monitoring program. The course must include,
384 but need not be limited to:
385 1. The purpose of the prescription drug monitoring program.
386 2. The practitioners’ capabilities for improving the
387 standard of care for patients by using the prescription drug
388 monitoring program.
389 3. How the prescription drug monitoring program can help
390 practitioners detect doctor shopping.
391 4. The involvement of law enforcement personnel, the
392 Attorney General’s Medicaid Fraud Unit, and medical regulatory
393 investigators with the prescription drug monitoring program.
394 5. The procedures for registering for access to the
395 prescription drug monitoring program.
396
397 The course hours may be included in the total number of hours of
398 continuing education required by the profession and must be
399 approved by the board or by the department if there is no board.
400 The boards, or the department if there is no board, shall
401 approve the course offered through a facility licensed under
402 chapter 395 for its employees if the course is at least 3 hours
403 and covers the education requirements.
404 (c) The course requirements in paragraph (b) apply to each
405 licensee renewing his or her license on or after July 1, 2012,
406 and to each applicant approved for licensure on or after January
407 1, 2013.
408 (d) By October 1, 2011, the boards, or the department if
409 there is no board, shall adopt rules as necessary to administer
410 this subsection.
411 Section 3. Section 458.305, Florida Statutes, is amended to
412 read:
413 458.305 Definitions.—As used in this chapter:
414 (1) “Board” means the Board of Medicine.
415 (2) “Department” means the Department of Health.
416 (3) “Dispensing physician” means a physician who is
417 registered as a dispensing practitioner under s. 465.0276.
418 (4)(3) “Practice of medicine” means the diagnosis,
419 treatment, operation, or prescription for any human disease,
420 pain, injury, deformity, or other physical or mental condition.
421 (5)(4) “Physician” means a person who is licensed to
422 practice medicine in this state.
423 Section 4. Advertising of controlled substances by a
424 dispensing physician.—
425 (1)(a) Only a dispensing physician licensed under chapter
426 458 or chapter 459, Florida Statutes, may use the title
427 “dispensing physician” or “dispenser” or otherwise lead the
428 public to believe that he or she is engaged in the dispensing of
429 controlled substances.
430 (b) A person, other than an owner of a:
431 1. Pain-management clinic registered under chapter 458 or
432 chapter 459, Florida Statutes; or
433 2. Health clinic licensed under chapter 400, Florida
434 Statutes,
435
436 may not display any sign or take any other action that would
437 lead the public to believe that such person is engaged in the
438 business of dispensing a controlled substance. Any advertisement
439 that states “dispensing onsite” or “onsite pharmacy” violates
440 this paragraph. This paragraph does not preclude a person who is
441 not licensed as a medical practitioner from owning a pain
442 management clinic.
443 (c) A person, firm, or corporation, unless licensed under
444 chapter 465, Florida Statutes, may not use in a trade name,
445 sign, letter, or advertisement any term, including “drug,”
446 “pharmacy,” “onsite pharmacy,” “dispensing,” “dispensing
447 onsite,” “prescription drugs,” “Rx,” or “apothecary,” which
448 implies that the person, firm, or corporation is licensed or
449 registered to dispense prescription drugs in this state.
450 (2) A person who violates paragraph (1)(a) or paragraph
451 (1)(b) commits a misdemeanor of the first degree, punishable as
452 provided in s. 775.082 or s. 775.083, Florida Statutes. A person
453 who violates paragraph (1)(c) commits a felony of the third
454 degree, punishable as provided in s. 775.082, s. 775.083, or s.
455 775.084, Florida Statutes. In any warrant, information, or
456 indictment, it is not necessary to negate any exceptions, and
457 the burden of any exception is upon the defendant.
458 Section 5. Paragraph (a) of subsection (1) of section
459 458.3191, Florida Statutes, is amended to read:
460 458.3191 Physician survey.—
461 (1) Each person who applies for licensure renewal as a
462 physician under this chapter or chapter 459 must, in conjunction
463 with the renewal of such license under procedures adopted by the
464 Department of Health and in addition to any other information
465 that may be required from the applicant, furnish the following
466 to the Department of Health in a physician survey:
467 (a) Licensee information, including, but not limited to:
468 1. Frequency and geographic location of practice within the
469 state.
470 2. Practice setting.
471 3. Percentage of time spent in direct patient care.
472 4. Anticipated change to license or practice status.
473 5. Areas of specialty or certification.
474 6. Whether the department has ever approved or denied the
475 physician’s registration for access to a patient’s information
476 in the prescription drug monitoring program’s database.
477 7. Whether the physician uses the prescription drug
478 monitoring program with patients in his or her medical practice.
479 Section 6. Subsection (3) is added to section 458.3192,
480 Florida Statutes, to read:
481 458.3192 Analysis of survey results; report.—
482 (3) By November 1 each year, the Department of Health shall
483 provide nonidentifying information to the prescription drug
484 monitoring program’s Implementation and Oversight Task Force
485 regarding the number of physicians who are registered with the
486 prescription drug monitoring program and who also use the
487 database from the prescription drug monitoring program for their
488 patients in their medical practice.
489 Section 7. Paragraph (a) of subsection (1) and paragraphs
490 (a) and (c) of subsection (2) of section 458.3265, Florida
491 Statutes, are amended, and paragraphs (f) and (g) are added to
492 subsection (5) of that section, to read:
493 458.3265 Pain-management clinics.—
494 (1) REGISTRATION.—
495 (a) All privately owned pain-management clinics,
496 facilities, or offices, hereinafter referred to as “clinics,”
497 which advertise in any medium for any type of pain-management
498 services, or employ a physician who is primarily engaged in the
499 treatment of pain by prescribing or dispensing controlled
500 substance medications, must register with the department unless:
501 1. That clinic is licensed as a facility pursuant to
502 chapter 395;
503 2. The majority of the physicians who provide services in
504 the clinic primarily provide surgical services or interventional
505 pain procedures of the type routinely billed using surgical
506 codes;
507 3. The clinic is owned by a publicly held corporation whose
508 shares are traded on a national exchange or on the over-the
509 counter market and whose total assets at the end of the
510 corporation’s most recent fiscal quarter exceeded $50 million;
511 4. The clinic is affiliated with an accredited medical
512 school at which training is provided for medical students,
513 residents, or fellows;
514 5. The clinic does not prescribe or dispense controlled
515 substances for the treatment of pain; or
516 6. The clinic is owned by a corporate entity exempt from
517 federal taxation under 26 U.S.C. s. 501(c)(3).
518 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
519 apply to any physician who provides professional services in a
520 pain-management clinic that is required to be registered in
521 subsection (1).
522 (a) A physician may not practice medicine in a pain
523 management clinic, as described in subsection (4), if:
524 1. the pain-management clinic is not registered with the
525 department as required by this section.; or
526 2. Effective July 1, 2012, the physician has not
527 successfully completed a pain-medicine fellowship that is
528 accredited by the Accreditation Council for Graduate Medical
529 Education or a pain-medicine residency that is accredited by the
530 Accreditation Council for Graduate Medical Education or, prior
531 to July 1, 2012, does not comply with rules adopted by the
532 board.
533
534 Any physician who qualifies to practice medicine in a pain
535 management clinic pursuant to rules adopted by the Board of
536 Medicine as of July 1, 2012, may continue to practice medicine
537 in a pain-management clinic as long as the physician continues
538 to meet the qualifications set forth in the board rules. A
539 physician who violates this paragraph is subject to disciplinary
540 action by his or her appropriate medical regulatory board.
541 (c) A physician, an advanced registered nurse practitioner,
542 or a physician assistant must perform an appropriate medical a
543 physical examination of a patient on the same day that the
544 physician he or she dispenses or prescribes a controlled
545 substance to a patient at a pain-management clinic. If the
546 physician prescribes or dispenses more than a 72-hour dose of
547 controlled substances for the treatment of chronic nonmalignant
548 pain, the physician must document in the patient’s record the
549 reason such dosage is within the standard of care. For the
550 purpose of this paragraph, the standard of care is set forth in
551 rule 64B8-9.013(3), Florida Administrative Code for prescribing
552 or dispensing that quantity.
553 (5) PENALTIES; ENFORCEMENT.—
554 (f) A licensee or other person who serves as the designated
555 physician of a pain-management clinic as defined in this section
556 or s. 459.0137 and registers a pain-management clinic through
557 misrepresentation or fraud or procures or attempts to procure
558 the registration of a pain-management clinic for any other
559 person by making or causing to be made any false or fraudulent
560 representation commits a felony of the third degree, punishable
561 as provided in s. 775.082, s. 775.083, or s. 775.084.
562 (g) Any person who registers a pain-management clinic
563 through misrepresentation or fraud or who procures or attempts
564 to procure the registration of a pain-management clinic for any
565 other person by making or causing to be made any false or
566 fraudulent representation, commits a felony of the third degree,
567 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
568 Section 8. Paragraphs (f) and (g) are added to subsection
569 (1), paragraphs (g) and (h) are added to subsection (2), and
570 subsection (3) is added to section 458.327, Florida Statutes, to
571 read:
572 458.327 Penalty for violations.—
573 (1) Each of the following acts constitutes a felony of the
574 third degree, punishable as provided in s. 775.082, s. 775.083,
575 or s. 775.084:
576 (f) Failing to perform a physical examination of a patient
577 by a physician or a licensed designee acting under the
578 physician’s supervision on the same day that the treating
579 physician dispenses or prescribes a controlled substance to the
580 patient at a pain-management clinic occurring three or more
581 times within a 6-month period, or failing to perform a physical
582 examination on three or more different patients on the same day
583 that the treating physician dispenses or prescribes a controlled
584 substance to each patient at a pain-management clinic within a
585 6-month period.
586 (g) Prescribing or dispensing in excess of a 72-hour dose
587 of controlled substances at a pain-management clinic for the
588 treatment of chronic nonmalignant pain of a patient occurring
589 three or more times within a 6-month period without documenting
590 in the patient’s record the reason that such dosage is within
591 the standard of care. For the purpose of this paragraph, the
592 standard of care is set forth in rule 64B8-9.013(3), Florida
593 Administrative Code.
594 (2) Each of the following acts constitutes a misdemeanor of
595 the first degree, punishable as provided in s. 775.082 or s.
596 775.083:
597 (g) Failing to perform a physical examination of a patient
598 on the same day that the treating physician dispenses or
599 prescribes a controlled substance to the patient at a pain
600 management clinic two times in a 6-month period, or failing to
601 perform a physical examination on two different patients on the
602 same day that the treating physician dispenses or prescribes a
603 controlled substance to each patient at a pain-management clinic
604 within a 6-month period.
605 (h) Prescribing or dispensing in excess of a 72-hour dose
606 of controlled substances at a pain-management clinic for the
607 treatment of chronic nonmalignant pain of a patient occurring
608 two times within a 6-month period without documenting in the
609 patient’s record the reason that such dosage is within the
610 standard of care. For the purpose of this paragraph, the
611 standard of care is set forth in rule 64B8-9.013(3), Florida
612 Administrative Code.
613 (3) Each of the following acts constitutes a misdemeanor of
614 the second degree, punishable as provided in s. 775.082 or s.
615 775.083:
616 (a) A first offense of failing to perform a physical
617 examination of a patient on the same day that the treating
618 physician dispenses or prescribes a controlled substance to the
619 patient at a pain-management clinic.
620 (b) A first offense of failing to document in a patient’s
621 record the reason that such dosage is within the standard of
622 care for prescribing or dispensing in excess of a 72-hour dose
623 of controlled substances at a pain-management clinic for the
624 treatment of chronic nonmalignant pain.
625 Section 9. Subsection (11) is added to section 458.331,
626 Florida Statutes, to read:
627 458.331 Grounds for disciplinary action; action by the
628 board and department.—
629 (11) Notwithstanding subsection (2), upon finding that a
630 physician has prescribed or dispensed, or caused to be
631 prescribed or dispensed, a controlled substance in a pain
632 management clinic in a manner that violates the standard of
633 practice as set forth in this chapter or rules adopted pursuant
634 to this chapter, the board shall, at a minimum, suspend the
635 physician’s license for at least 6 months and impose a fine of
636 at least $10,000 per count. Repeated violations shall result in
637 increased penalties.
638 Section 10. Present subsections (3), (4), and (5) of
639 section 459.003, Florida Statutes, are redesignated as
640 subsections (4), (5), and (6), respectively, and a new
641 subsection (3) is added to that section, to read:
642 459.003 Definitions.—As used in this chapter:
643 (3) “Dispensing physician” means an osteopathic physician
644 who is registered as a dispensing practitioner under s.
645 465.0276.
646 Section 11. Paragraphs (f) and (g) are added to subsection
647 (1), paragraphs (e) and (f) are added to subsection (2), and
648 paragraphs (d) and (e) are added to subsection (3) of section
649 459.013, Florida Statutes, to read:
650 459.013 Penalty for violations.—
651 (1) Each of the following acts constitutes a felony of the
652 third degree, punishable as provided in s. 775.082, s. 775.083,
653 or s. 775.084:
654 (f) Failing to perform a physical examination of a patient
655 on the same day that the osteopathic physician dispenses or
656 prescribes a controlled substance to the patient at a pain
657 management clinic occurring three or more times within a 6-month
658 period, or failing to perform a physical examination on three or
659 more different patients on the same day that the osteopathic
660 physician dispenses or prescribes a controlled substance to each
661 patient at a pain-management clinic within a 6-month period.
662 (g) Prescribing or dispensing in excess of a 72-hour dose
663 of controlled substances at a pain-management clinic for the
664 treatment of chronic nonmalignant pain of a patient occurring
665 three or more times within a 6-month period without documenting
666 in the patient’s record the reason that such dosage is within
667 the standard of care. For the purpose of this paragraph, the
668 standard of care is set forth in rule 64B8-9.013(3), Florida
669 Administrative Code.
670 (2) Each of the following acts constitutes a misdemeanor of
671 the first degree, punishable as provided in s. 775.082 or s.
672 775.083:
673 (e) Failing to perform a physical examination of a patient
674 on the same day that the osteopathic physician dispenses or
675 prescribes a controlled substance to the patient at a pain
676 management clinic occurring two times within a 6-month period,
677 or failing to perform a physical examination on two different
678 patients on the same day that the osteopathic physician
679 dispenses or prescribes a controlled substance to each patient
680 at a pain-management clinic within a 6-month period.
681 (f) Prescribing or dispensing in excess of a 72-hour dose
682 of controlled substances at a pain-management clinic for the
683 treatment of chronic nonmalignant pain of a patient occurring
684 two times within a 6-month period without documenting in the
685 patient’s record the reason that such dosage is within the
686 standard of care. For the purpose of this paragraph, the
687 standard of care is set forth in rule 64B8-9.013(3), Florida
688 Administrative Code.
689 (3) Each of the following constitutes a misdemeanor of the
690 second degree, punishable as provided in s. 775.082 or s.
691 775.083:
692 (d) A first offense of failing to perform a physical
693 examination of a patient on the same day that the osteopathic
694 physician dispenses or prescribes a controlled substance to the
695 patient at a pain-management clinic.
696 (e) A first offense of failing to document in a patient’s
697 record the reason that such dosage is within the standard of
698 care for prescribing or dispensing in excess of a 72-hour dose
699 of controlled substances at a pain-management clinic for the
700 treatment of chronic nonmalignant pain. For the purpose of this
701 paragraph, the standard of care is set forth in rule 64B8
702 9.013(3), Florida Administrative Code.
703 Section 12. Paragraph (a) of subsection (1) and paragraph
704 (c) of subsection (2) of section 459.0137, Florida Statutes, are
705 amended, and paragraphs (f) and (g) are added to subsection (5)
706 of that section, to read:
707 459.0137 Pain-management clinics.—
708 (1) REGISTRATION.—
709 (a) All privately owned pain-management clinics,
710 facilities, or offices, hereinafter referred to as “clinics,”
711 which advertise in any medium for any type of pain-management
712 services, or employ an osteopathic physician who is primarily
713 engaged in the treatment of pain by prescribing or dispensing
714 controlled substance medications, must register with the
715 department unless:
716 1. That clinic is licensed as a facility pursuant to
717 chapter 395;
718 2. The majority of the physicians who provide services in
719 the clinic primarily provide surgical services or interventional
720 pain procedures of the type routinely billed using surgical
721 codes;
722 3. The clinic is owned by a publicly held corporation whose
723 shares are traded on a national exchange or on the over-the
724 counter market and whose total assets at the end of the
725 corporation’s most recent fiscal quarter exceeded $50 million;
726 4. The clinic is affiliated with an accredited medical
727 school at which training is provided for medical students,
728 residents, or fellows;
729 5. The clinic does not prescribe or dispense controlled
730 substances for the treatment of pain; or
731 6. The clinic is owned by a corporate entity exempt from
732 federal taxation under 26 U.S.C. s. 501(c)(3).
733 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
734 apply to any osteopathic physician who provides professional
735 services in a pain-management clinic that is required to be
736 registered in subsection (1).
737 (c) An osteopathic physician, an advanced registered nurse
738 practitioner, or a physician assistant must perform an
739 appropriate medical a physical examination of a patient on the
740 same day that the physician he or she dispenses or prescribes a
741 controlled substance to a patient at a pain-management clinic.
742 If the osteopathic physician prescribes or dispenses more than a
743 72-hour dose of controlled substances for the treatment of
744 chronic nonmalignant pain, the osteopathic physician must
745 document in the patient’s record the reason for which
746 prescribing or dispensing a dosage in excess of a 72-hour dose
747 of controlled substances for the treatment of chronic
748 nonmalignant pain is within the standard of care for prescribing
749 or dispensing that quantity.
750 (5) PENALTIES; ENFORCEMENT.—
751 (f) A licensee or other person who serves as the designated
752 physician of a pain-management clinic as defined in s. 458.3265
753 or s. 459.0137 and registers a pain-management clinic through
754 intentional misrepresentation or fraud or procures or attempts
755 to procure the registration of a pain-management clinic for any
756 other person by making or causing to be made any false or
757 fraudulent representation commits a felony of the third degree,
758 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
759 (g) Any person who registers a pain-management clinic
760 through misrepresentation or fraud or who procures or attempts
761 to procure the registration of a pain-management clinic for any
762 other person by making or causing to be made any false or
763 fraudulent representation, commits a felony of the third degree,
764 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
765 Section 13. Subsection (11) is added to section 459.015,
766 Florida Statutes, to read:
767 459.015 Grounds for disciplinary action; action by the
768 board and department.—
769 (11) Notwithstanding subsection (2), upon finding that an
770 osteopathic physician has prescribed or dispensed, or caused to
771 be prescribed or dispensed, a controlled substance in a pain
772 management clinic in a manner that violates the standard of
773 practice as set forth in this chapter or rules adopted pursuant
774 to this chapter, the board shall, at a minimum, suspend the
775 osteopathic physician’s license for at least 6 months and impose
776 a fine of at least $10,000 per count. Repeated violations shall
777 result in increased penalties.
778 Section 14. Present subsections (3) and (4) of section
779 465.015, Florida Statutes, are renumbered as subsections (4) and
780 (5), respectively, and a new subsection (3) is added to that
781 section, to read:
782 465.015 Violations and penalties.—
783 (3)(a) A licensed pharmacist, pharmacy technician, or any
784 person working under the direction or supervision of a
785 pharmacist or pharmacy technician, may not knowingly fail to
786 timely report to the local county sheriff’s office the name of
787 any person who obtains or attempts to obtain a substance
788 controlled by s. 893.03 which the pharmacist, pharmacy intern,
789 or other person employed by or at a pharmacy knows or reasonably
790 should have known was obtained or attempted to be obtained from
791 the pharmacy through any fraudulent method or representation. A
792 pharmacist, pharmacy intern, or other person employed by or at a
793 pharmacy who fails to make such a report within 24 hours after
794 learning of the fraud or attempted fraud commits a misdemeanor
795 of the first degree, punishable as provided in s. 775.082 or s.
796 775.083.
797 (b) A sufficient report of the fraudulent obtaining of or
798 attempt to obtain a controlled substance under this section must
799 contain, at a minimum, a copy of the prescription used or
800 presented and a narrative, including all information available
801 to the pharmacy regarding:
802 1. The transaction, such as the name and telephone number
803 of the prescribing physician;
804 2. The name, description, and any personal identification
805 information pertaining to the person presenting the
806 prescription; and
807 3. All other material information, such as photographic or
808 video surveillance of the transaction.
809
810 A pharmacist, pharmacy intern, or other person employed by or at
811 a pharmacy is not subject to disciplinary action for reporting
812 under this subsection.
813 Section 15. Subsection (6) is added to section 465.0276,
814 Florida Statutes, to read:
815 465.0276 Dispensing practitioner.—
816 (6) In order to dispense a controlled substance listed in
817 Schedule II, Schedule III, or Schedule IV in s. 893.03, a
818 practitioner authorized by law to prescribe a controlled
819 substance shall register with the Board of Pharmacy as a
820 dispensing practitioner who dispenses controlled substances and
821 pay a fee not to exceed $100. The department shall adopt rules
822 establishing procedures for renewal of the registration every 4
823 years.
824 Section 16. Paragraph (a) of subsection (1) of section
825 766.101, Florida Statutes, is amended to read:
826 766.101 Medical review committee, immunity from liability.—
827 (1) As used in this section:
828 (a) The term “medical review committee” or “committee”
829 means:
830 1.a. A committee of a hospital or ambulatory surgical
831 center licensed under chapter 395 or a health maintenance
832 organization certificated under part I of chapter 641,
833 b. A committee of a physician-hospital organization, a
834 provider-sponsored organization, or an integrated delivery
835 system,
836 c. A committee of a state or local professional society of
837 health care providers,
838 d. A committee of a medical staff of a licensed hospital or
839 nursing home, provided the medical staff operates pursuant to
840 written bylaws that have been approved by the governing board of
841 the hospital or nursing home,
842 e. A committee of the Department of Corrections or the
843 Correctional Medical Authority as created under s. 945.602, or
844 employees, agents, or consultants of either the department or
845 the authority or both,
846 f. A committee of a professional service corporation formed
847 under chapter 621 or a corporation organized under chapter 607
848 or chapter 617, which is formed and operated for the practice of
849 medicine as defined in s. 458.305(4) s. 458.305(3), and which
850 has at least 25 health care providers who routinely provide
851 health care services directly to patients,
852 g. A committee of the Department of Children and Family
853 Services which includes employees, agents, or consultants to the
854 department as deemed necessary to provide peer review,
855 utilization review, and mortality review of treatment services
856 provided pursuant to chapters 394, 397, and 916,
857 h. A committee of a mental health treatment facility
858 licensed under chapter 394 or a community mental health center
859 as defined in s. 394.907, provided the quality assurance program
860 operates pursuant to the guidelines which have been approved by
861 the governing board of the agency,
862 i. A committee of a substance abuse treatment and education
863 prevention program licensed under chapter 397 provided the
864 quality assurance program operates pursuant to the guidelines
865 which have been approved by the governing board of the agency,
866 j. A peer review or utilization review committee organized
867 under chapter 440,
868 k. A committee of the Department of Health, a county health
869 department, healthy start coalition, or certified rural health
870 network, when reviewing quality of care, or employees of these
871 entities when reviewing mortality records, or
872 l. A continuous quality improvement committee of a pharmacy
873 licensed pursuant to chapter 465,
874
875 which committee is formed to evaluate and improve the quality of
876 health care rendered by providers of health service, to
877 determine that health services rendered were professionally
878 indicated or were performed in compliance with the applicable
879 standard of care, or that the cost of health care rendered was
880 considered reasonable by the providers of professional health
881 services in the area; or
882 2. A committee of an insurer, self-insurer, or joint
883 underwriting association of medical malpractice insurance, or
884 other persons conducting review under s. 766.106.
885 Section 17. Subsection (3) of section 810.02, Florida
886 Statutes, is amended to read:
887 810.02 Burglary.—
888 (3) Burglary is a felony of the second degree, punishable
889 as provided in s. 775.082, s. 775.083, or s. 775.084, if, in the
890 course of committing the offense, the offender does not make an
891 assault or battery and is not and does not become armed with a
892 dangerous weapon or explosive, and the offender enters or
893 remains in a:
894 (a) Dwelling, and there is another person in the dwelling
895 at the time the offender enters or remains;
896 (b) Dwelling, and there is not another person in the
897 dwelling at the time the offender enters or remains;
898 (c) Structure, and there is another person in the structure
899 at the time the offender enters or remains;
900 (d) Conveyance, and there is another person in the
901 conveyance at the time the offender enters or remains; or
902 (e) Authorized emergency vehicle, as defined in s. 316.003;
903 or.
904 (f) Structure or conveyance when the offense intended to be
905 committed is theft of a substance controlled by s. 893.03.
906 Notwithstanding any contrary provisions of law, separate
907 judgments and sentences for burglary with the intent to commit
908 theft of a controlled substance under this paragraph and for any
909 applicable offense for possession of a controlled substance
910 under s. 893.13, or an offense for trafficking in a controlled
911 substance under s. 893.135, may be imposed if all such offenses
912 involve the same amount or amounts of a controlled substance.
913
914 However, if the burglary is committed within a county that is
915 subject to a state of emergency declared by the Governor under
916 chapter 252 after the declaration of emergency is made and the
917 perpetration of the burglary is facilitated by conditions
918 arising from the emergency, the burglary is a felony of the
919 first degree, punishable as provided in s. 775.082, s. 775.083,
920 or s. 775.084. As used in this subsection, the term “conditions
921 arising from the emergency” means civil unrest, power outages,
922 curfews, voluntary or mandatory evacuations, or a reduction in
923 the presence of or response time for first responders or
924 homeland security personnel. A person arrested for committing a
925 burglary within a county that is subject to such a state of
926 emergency may not be released until the person appears before a
927 committing magistrate at a first appearance hearing. For
928 purposes of sentencing under chapter 921, a felony offense that
929 is reclassified under this subsection is ranked one level above
930 the ranking under s. 921.0022 or s. 921.0023 of the offense
931 committed.
932 Section 18. Paragraph (c) of subsection (2) of section
933 812.014, Florida Statutes, is amended to read:
934 812.014 Theft.—
935 (2)
936 (c) It is grand theft of the third degree and a felony of
937 the third degree, punishable as provided in s. 775.082, s.
938 775.083, or s. 775.084, if the property stolen is:
939 1. Valued at $300 or more, but less than $5,000.
940 2. Valued at $5,000 or more, but less than $10,000.
941 3. Valued at $10,000 or more, but less than $20,000.
942 4. A will, codicil, or other testamentary instrument.
943 5. A firearm.
944 6. A motor vehicle, except as provided in paragraph (a).
945 7. Any commercially farmed animal, including any animal of
946 the equine, bovine, or swine class, or other grazing animal, and
947 including aquaculture species raised at a certified aquaculture
948 facility. If the property stolen is aquaculture species raised
949 at a certified aquaculture facility, then a $10,000 fine shall
950 be imposed.
951 8. Any fire extinguisher.
952 9. Any amount of citrus fruit consisting of 2,000 or more
953 individual pieces of fruit.
954 10. Taken from a designated construction site identified by
955 the posting of a sign as provided for in s. 810.09(2)(d).
956 11. Any stop sign.
957 12. Anhydrous ammonia.
958 13. Any amount of a substance controlled by s. 893.03.
959 Notwithstanding any contrary provisions of law, separate
960 judgments and sentences for theft of a controlled substance
961 under this subparagraph, and for any applicable offense for
962 possession of a controlled substance under s. 893.13, or an
963 offense for trafficking in a controlled substance under s.
964 893.135 may be imposed if all such offenses involve the same
965 amount or amounts of controlled substance.
966
967 However, if the property is stolen within a county that is
968 subject to a state of emergency declared by the Governor under
969 chapter 252, the property is stolen after the declaration of
970 emergency is made, and the perpetration of the theft is
971 facilitated by conditions arising from the emergency, the
972 offender commits a felony of the second degree, punishable as
973 provided in s. 775.082, s. 775.083, or s. 775.084, if the
974 property is valued at $5,000 or more, but less than $10,000, as
975 provided under subparagraph 2., or if the property is valued at
976 $10,000 or more, but less than $20,000, as provided under
977 subparagraph 3. As used in this paragraph, the term “conditions
978 arising from the emergency” means civil unrest, power outages,
979 curfews, voluntary or mandatory evacuations, or a reduction in
980 the presence of or the response time for first responders or
981 homeland security personnel. For purposes of sentencing under
982 chapter 921, a felony offense that is reclassified under this
983 paragraph is ranked one level above the ranking under s.
984 921.0022 or s. 921.0023 of the offense committed.
985 Section 19. Section 893.021, Florida Statutes, is created
986 to read:
987 893.021 Adulterated drug.—
988 (1) As used in this chapter, a drug is adulterated if it is
989 a controlled substance that:
990 (a) Has been produced, prepared, packed, and marketed for
991 oral consumption by the manufacturer; and
992 (b) Has had any change to its integrity or composition for
993 use by means of inhalation, injection, or any other form of
994 ingestion not in accordance with the manufacturer’s recommended
995 use, and such mode of use has not been previously directed and
996 approved by the prescribing physician.
997 (2) A physician is not prevented from directing or
998 prescribing a change to the recognized manufactured
999 recommendations for use in a patient who presents a medical need
1000 for such a requirement change of any controlled substance. The
1001 prescribing physician shall clearly indicate any deviation of
1002 the recognized manufacturer’s recommended use of a controlled
1003 substance on the original prescription, and the licensed
1004 pharmacist shall clearly indicate such deviation on the label of
1005 the prescription upon dispensing the controlled substance.
1006 Section 20. Paragraphs (c), (d), and (e) of subsection (1)
1007 of section 893.04, Florida Statutes, are amended to read:
1008 893.04 Pharmacist and practitioner.—
1009 (1) A pharmacist, in good faith and in the course of
1010 professional practice only, may dispense controlled substances
1011 upon a written or oral prescription of a practitioner, under the
1012 following conditions:
1013 (c) The following information must There shall appear on
1014 the face of the prescription or written record of a thereof for
1015 the controlled substance the following information:
1016 1. The full name and address of the person for whom, or the
1017 owner of the animal for which, the controlled substance is
1018 dispensed.
1019 2. The full name and address of the prescribing
1020 practitioner and the practitioner’s federal controlled substance
1021 registry number shall be printed thereon.
1022 3. If the prescription is for an animal, the species of
1023 animal for which the controlled substance is prescribed.
1024 4. The name of the controlled substance prescribed and the
1025 strength, quantity, and directions for use thereof. The
1026 directions for use must specify the authorization by the
1027 physician, any instructions requiring the adulteration of the
1028 dispensed form of the medication, and the medical necessity for
1029 the adulteration in accordance with s. 893.021.
1030 5. The number of the prescription, as recorded in the
1031 prescription files of the pharmacy in which it is filled.
1032 6. The initials of the pharmacist filling the prescription
1033 and the date filled.
1034 (d) The prescription must shall be retained on file by the
1035 proprietor of the pharmacy in which it is filled for a period of
1036 2 years.
1037 (e) A label bearing the following information must be
1038 affixed to the original container in which a controlled
1039 substance is delivered as upon a prescription or authorized
1040 refill thereof, as hereinafter provided, there shall be a label
1041 bearing the following information:
1042 1. The name and address of the pharmacy from which such
1043 controlled substance was dispensed.
1044 2. The date on which the prescription for such controlled
1045 substance was filled.
1046 3. The number of such prescription, as recorded in the
1047 prescription files of the pharmacy in which it is filled.
1048 4. The name of the prescribing practitioner.
1049 5. The name of the patient for whom, or of the owner and
1050 species of the animal for which, the controlled substance is
1051 prescribed.
1052 6. The directions for the use of the controlled substance
1053 prescribed in the prescription.
1054 7. A clear, concise warning that it is a crime to transfer
1055 the controlled substance to any person other than the patient
1056 for whom prescribed.
1057 Section 21. Section 893.055, Florida Statutes, is amended
1058 to read:
1059 893.055 Prescription drug monitoring program.—
1060 (1) As used in this section, the term:
1061 (a) “Patient advisory report” or “advisory report” means
1062 information provided by the department in writing, or as
1063 determined by the department, to a prescriber, dispenser,
1064 pharmacy, or patient concerning the dispensing of controlled
1065 substances. All advisory reports are for informational purposes
1066 only and impose no obligations of any nature or any legal duty
1067 on a prescriber, dispenser, pharmacy, or patient. The patient
1068 advisory report shall be provided in accordance with s.
1069 893.13(7)(a)8. The advisory reports issued by the department are
1070 not subject to discovery or introduction into evidence in any
1071 civil or administrative action against a prescriber, dispenser,
1072 pharmacy, or patient arising out of matters that are the subject
1073 of the report; and a person who participates in preparing,
1074 reviewing, issuing, or any other activity related to an advisory
1075 report may not be permitted or required to testify in any such
1076 civil action as to any findings, recommendations, evaluations,
1077 opinions, or other actions taken in connection with preparing,
1078 reviewing, or issuing such a report.
1079 (b) “Controlled substance” means a controlled substance
1080 listed in Schedule II, Schedule III, or Schedule IV in s.
1081 893.03.
1082 (c) “Dispenser” means a pharmacy, dispensing pharmacist, or
1083 dispensing health care practitioner.
1084 (d) “Health care practitioner” or “practitioner” means any
1085 practitioner who is subject to licensure or regulation by the
1086 department under chapter 458, chapter 459, chapter 461, chapter
1087 462, chapter 464, chapter 465, or chapter 466.
1088 (e) “Health care regulatory board” means any board for a
1089 practitioner or health care practitioner who is licensed or
1090 regulated by the department.
1091 (f) “Pharmacy” means any pharmacy that is subject to
1092 licensure or regulation by the department under chapter 465 and
1093 that dispenses or delivers a controlled substance to an
1094 individual or address in this state.
1095 (g) “Prescriber” means a prescribing physician, prescribing
1096 practitioner, or other prescribing health care practitioner.
1097 (h) “Active investigation” means an investigation that is
1098 being conducted with a reasonable, good faith belief that it
1099 could lead to the filing of administrative, civil, or criminal
1100 proceedings, or that is ongoing and continuing and for which
1101 there is a reasonable, good faith anticipation of securing an
1102 arrest or prosecution in the foreseeable future.
1103 (i) “Law enforcement agency” means the Department of Law
1104 Enforcement, a Florida sheriff’s department, a Florida police
1105 department, or a law enforcement agency of the Federal
1106 Government which enforces the laws of this state or the United
1107 States relating to controlled substances, and which its agents
1108 and officers are empowered by law to conduct criminal
1109 investigations and make arrests.
1110 (j) “Program manager” means an employee of or a person
1111 contracted by the Department of Health who is designated to
1112 ensure the integrity of the prescription drug monitoring program
1113 in accordance with the requirements established in paragraphs
1114 (2)(a) and (b).
1115 (2)(a) By December 1, 2010, the department shall design and
1116 establish a comprehensive electronic database system that has
1117 controlled substance prescriptions provided to it and that
1118 provides prescription information to a patient’s health care
1119 practitioner and pharmacist who inform the department that they
1120 wish the patient advisory report provided to them. Otherwise,
1121 the patient advisory report will not be sent to the
1122 practitioner, pharmacy, or pharmacist. The system shall be
1123 designed to provide information regarding dispensed
1124 prescriptions of controlled substances and shall not infringe
1125 upon the legitimate prescribing or dispensing of a controlled
1126 substance by a prescriber or dispenser acting in good faith and
1127 in the course of professional practice. The system shall be
1128 consistent with standards of the American Society for Automation
1129 in Pharmacy (ASAP). The electronic system shall also comply with
1130 the Health Insurance Portability and Accountability Act (HIPAA)
1131 as it pertains to protected health information (PHI), electronic
1132 protected health information (EPHI), the National All Schedules
1133 Prescription Electronic Reporting (NASPER) Act’s minimum
1134 requirements for authentication of a practitioner who requests
1135 information in the prescription drug monitoring program database
1136 and certification of the purpose for which information is
1137 requested, and all other relevant state and federal privacy and
1138 security laws and regulations. The department shall establish
1139 policies and procedures as appropriate regarding the reporting,
1140 accessing the database, evaluation, management, development,
1141 implementation, operation, storage, and security of information
1142 within the system. The reporting of prescribed controlled
1143 substances shall include a dispensing transaction with a
1144 dispenser pursuant to chapter 465 or through a dispensing
1145 transaction to an individual or address in this state with a
1146 pharmacy that is not located in this state but that is otherwise
1147 subject to the jurisdiction of this state as to that dispensing
1148 transaction. The reporting of patient advisory reports refers
1149 only to reports to patients, pharmacies, and practitioners.
1150 Separate reports that contain patient prescription history
1151 information and that are not patient advisory reports are
1152 provided to persons and entities as authorized in paragraphs
1153 (7)(b) and (c) and s. 893.0551.
1154 (b) The department, when the direct support organization
1155 receives at least $20,000 in nonstate moneys or the state
1156 receives at least $20,000 in federal grants for the prescription
1157 drug monitoring program, and in consultation with the Office of
1158 Drug Control, shall adopt rules as necessary concerning the
1159 reporting, accessing the database, evaluation, management,
1160 development, implementation, operation, security, and storage of
1161 information within the system, including rules for when patient
1162 advisory reports are provided to pharmacies and prescribers. The
1163 patient advisory report shall be provided in accordance with s.
1164 893.13(7)(a)8. The department shall work with the professional
1165 health care licensure boards, such as the Board of Medicine, the
1166 Board of Osteopathic Medicine, and the Board of Pharmacy; other
1167 appropriate organizations, such as the Florida Pharmacy
1168 Association, the Office of Drug Control, the Florida Medical
1169 Association, the Florida Retail Federation, and the Florida
1170 Osteopathic Medical Association, including those relating to
1171 pain management; and the Attorney General, the Department of Law
1172 Enforcement, and the Agency for Health Care Administration to
1173 develop rules appropriate for the prescription drug monitoring
1174 program.
1175 (c) All dispensers and prescribers subject to these
1176 reporting requirements shall be notified by the department of
1177 the implementation date for such reporting requirements.
1178 (d) The program manager shall work with professional health
1179 care licensure boards and the stakeholders listed in paragraph
1180 (b) to develop rules appropriate for identifying indicators of
1181 controlled substance abuse.
1182 (e) The department shall establish a method to allow
1183 corrections to the database when notified by a health care
1184 practitioner or pharmacist.
1185 (3) The pharmacy dispensing the controlled substance and
1186 each prescriber who directly dispenses a controlled substance
1187 shall submit to the electronic system, by a procedure and in a
1188 format established by the department and consistent with an
1189 ASAP-approved format, the following information for inclusion in
1190 the database:
1191 (a) The name of the prescribing practitioner, the
1192 practitioner’s federal Drug Enforcement Administration
1193 registration number, the practitioner’s National Provider
1194 Identification (NPI) or other appropriate identifier, and the
1195 date of the prescription.
1196 (b) The date the prescription was filled and the method of
1197 payment, such as cash by an individual, insurance coverage
1198 through a third party, or Medicaid payment. This paragraph does
1199 not authorize the department to include individual credit card
1200 numbers or other account numbers in the database.
1201 (c) The full name, address, and date of birth of the person
1202 for whom the prescription was written.
1203 (d) The name, national drug code, quantity, and strength of
1204 the controlled substance dispensed.
1205 (e) The full name, federal Drug Enforcement Administration
1206 registration number, and address of the pharmacy or other
1207 location from which the controlled substance was dispensed. If
1208 the controlled substance was dispensed by a practitioner other
1209 than a pharmacist, the practitioner’s full name, federal Drug
1210 Enforcement Administration registration number, and address.
1211 (f) The name of the pharmacy or practitioner, other than a
1212 pharmacist, dispensing the controlled substance and the
1213 practitioner’s National Provider Identification (NPI).
1214 (g) Other appropriate identifying information as determined
1215 by department rule.
1216 (h) The number of refills ordered and whether the drug was
1217 dispensed as a refill of a prescription or was a first-time
1218 request.
1219 (4) Each time a controlled substance is dispensed to an
1220 individual, the controlled substance shall be reported to the
1221 department through the system as soon thereafter as possible,
1222 but not more than 7 15 days after the date the controlled
1223 substance is dispensed unless an extension is approved by the
1224 department for cause as determined by rule. A dispenser must
1225 meet the reporting requirements of this section by providing the
1226 required information concerning each controlled substance that
1227 it dispensed in a department-approved, secure methodology and
1228 format. Such approved formats may include, but are not limited
1229 to, submission via the Internet, on a disc, or by use of regular
1230 mail.
1231 (5) When the following acts of dispensing or administering
1232 occur, the following are exempt from reporting under this
1233 section for that specific act of dispensing or administration:
1234 (a) A health care practitioner when administering a
1235 controlled substance directly to a patient if the amount of the
1236 controlled substance is adequate to treat the patient during
1237 that particular treatment session.
1238 (b) A pharmacist or health care practitioner when
1239 administering a controlled substance to a patient or resident
1240 receiving care as a patient at a hospital, nursing home,
1241 ambulatory surgical center, hospice, or intermediate care
1242 facility for the developmentally disabled which is licensed in
1243 this state.
1244 (c) A practitioner when administering or dispensing a
1245 controlled substance in the health care system of the Department
1246 of Corrections.
1247 (c)(d) A practitioner when administering a controlled
1248 substance in the emergency room of a licensed hospital.
1249 (d)(e) A health care practitioner when administering or
1250 dispensing a controlled substance to a person under the age of
1251 16 if the amount of the controlled substance is adequate to
1252 treat the patient during that particular treatment session.
1253 (e)(f) A pharmacist or a dispensing practitioner when
1254 dispensing a one-time, 48-hour 72-hour emergency resupply of a
1255 controlled substance to a patient.
1256 (6) The department may establish when to suspend and when
1257 to resume reporting information during a state-declared or
1258 nationally declared disaster.
1259 (7)(a) A practitioner or pharmacist who dispenses a
1260 controlled substance must submit the information required by
1261 this section in an electronic or other method in an ASAP format
1262 approved by rule of the department unless otherwise provided in
1263 this section. The cost to the dispenser in submitting the
1264 information required by this section may not be material or
1265 extraordinary. Costs not considered to be material or
1266 extraordinary include, but are not limited to, regular postage,
1267 electronic media, regular electronic mail, and facsimile
1268 charges.
1269 (b)1. In order for a pharmacy, prescriber, practitioner, or
1270 dispenser to shall have access to information in the
1271 prescription drug monitoring program’s database which relates to
1272 a patient of that pharmacy, prescriber, practitioner, or
1273 dispenser, the pharmacy, prescriber, practitioner, or dispenser
1274 shall register with the department by submitting a registering
1275 document provided by the department. The document and validation
1276 of that document shall be determined by the department. Before a
1277 pharmacy, prescriber, practitioner, or dispenser is granted
1278 access to information in the database from the prescription drug
1279 monitoring program, the department shall approve the submitted
1280 document. Upon approval, the department shall grant the
1281 registrant access to the appropriate information in the
1282 prescription drug monitoring program’s database in a manner
1283 established by the department as needed for the purpose of
1284 reviewing the patient’s controlled substance prescription
1285 history.
1286 2. Other access to the program’s database shall be limited
1287 to the program’s manager and to the designated program and
1288 support staff, who may act only at the direction of the program
1289 manager or, in the absence of the program manager, as
1290 authorized. Access by the program manager or such designated
1291 staff is for prescription drug program management only or for
1292 management of the program’s database and its system in support
1293 of the requirements of this section and in furtherance of the
1294 prescription drug monitoring program. Confidential and exempt
1295 information in the database shall be released only as provided
1296 in paragraph (c) and s. 893.0551. The program manager,
1297 designated program and support staff who act at the direction of
1298 or in the absence of the program manager, and any individual who
1299 has similar access regarding the management of the database from
1300 the prescription drug monitoring program shall submit
1301 fingerprints to the department for background screening. The
1302 department shall follow the procedure established by the
1303 Department of Law Enforcement to request a statewide criminal
1304 history record check and to request that the Department of Law
1305 Enforcement forward the fingerprints to the Federal Bureau of
1306 Investigation for a national criminal history record check.
1307 (c) The following entities may shall not have be allowed
1308 direct access to information in the prescription drug monitoring
1309 program database but may request from the program manager and,
1310 when authorized by the program manager, the program manager’s
1311 program and support staff, information that is confidential and
1312 exempt under s. 893.0551. Prior to release, the request shall be
1313 verified as authentic and authorized with the requesting
1314 organization by the program manager, the program manager’s
1315 program and support staff, or as determined in rules by the
1316 department as being authentic and as having been authorized by
1317 the requesting entity:
1318 1. The department or its relevant health care regulatory
1319 boards responsible for the licensure, regulation, or discipline
1320 of practitioners, pharmacists, or other persons who are
1321 authorized to prescribe, administer, or dispense controlled
1322 substances and who are involved in a specific controlled
1323 substance investigation involving a designated person for one or
1324 more prescribed controlled substances.
1325 2. The Attorney General for Medicaid fraud cases or
1326 Medicaid investigations involving prescribed controlled
1327 substances.
1328 3. A law enforcement agency during active investigations
1329 regarding potential criminal activity, fraud, or theft regarding
1330 prescribed controlled substances.
1331 4. A patient or the legal guardian or designated health
1332 care surrogate of an incapacitated patient as described in s.
1333 893.0551 who, for the purpose of verifying the accuracy of the
1334 database information, submits a written and notarized request
1335 that includes the patient’s full name, address, and date of
1336 birth, and includes the same information if the legal guardian
1337 or health care surrogate submits the request. The patient’s
1338 phone number, current address, and a copy of a government-issued
1339 photo identification must be provided in person to the program
1340 manager along with the notarized request. The request shall be
1341 validated by the department to verify the identity of the
1342 patient and the legal guardian or health care surrogate, if the
1343 patient’s legal guardian or health care surrogate is the
1344 requestor. Such verification is also required for any request to
1345 change a patient’s prescription history or other information
1346 related to his or her information in the electronic database.
1347 5. The Agency for Health Care Administration for Medicaid
1348 fraud cases or Medicaid investigations involving prescribed
1349 controlled substances.
1350
1351 Information in the database for the electronic prescription drug
1352 monitoring system is not discoverable or admissible in any civil
1353 or administrative action, except in an investigation and
1354 disciplinary proceeding by the department or the appropriate
1355 regulatory board.
1356 (d) The following entities may shall not have be allowed
1357 direct access to information in the prescription drug monitoring
1358 program database but may request from the program manager and,
1359 when authorized by the program manager, the program manager’s
1360 program and support staff, information that contains no
1361 identifying information of any patient, physician, health care
1362 practitioner, prescriber, or dispenser and that is not
1363 confidential and exempt:
1364 1. Department staff for the purpose of calculating
1365 performance measures pursuant to subsection (8).
1366 2. The Program Implementation and Oversight Task Force for
1367 its reporting to the Governor, the President of the Senate, and
1368 the Speaker of the House of Representatives regarding the
1369 prescription drug monitoring program. This subparagraph expires
1370 July 1, 2012.
1371 (e) All transmissions of data required by this section must
1372 comply with relevant state and federal privacy and security laws
1373 and regulations. However, any authorized agency or person under
1374 s. 893.0551 receiving such information as allowed by s. 893.0551
1375 may maintain the information received for up to 24 months before
1376 purging it from his or her records or maintain it for longer
1377 than 24 months if the information is pertinent to ongoing health
1378 care or an active law enforcement investigation or prosecution.
1379 (f) The program manager, upon determining a pattern
1380 consistent with the rules established under paragraph (2)(d) and
1381 having cause to believe a violation of s. 893.13(7)(a)8.,
1382 (8)(a), or (8)(b) has occurred, may provide relevant information
1383 to the applicable law enforcement agency.
1384 (8) To assist in fulfilling program responsibilities,
1385 performance measures shall be reported annually to the Governor,
1386 the President of the Senate, and the Speaker of the House of
1387 Representatives by the department each December 1, beginning in
1388 2011. Data that does not contain patient, physician, health care
1389 practitioner, prescriber, or dispenser identifying information
1390 may be requested during the year by department employees so that
1391 the department may undertake public health care and safety
1392 initiatives that take advantage of observed trends. Performance
1393 measures may include, but are not limited to, efforts to achieve
1394 the following outcomes:
1395 (a) Reduction of the rate of inappropriate use of
1396 prescription drugs through department education and safety
1397 efforts.
1398 (b) Reduction of the quantity of pharmaceutical controlled
1399 substances obtained by individuals attempting to engage in fraud
1400 and deceit.
1401 (c) Increased coordination among partners participating in
1402 the prescription drug monitoring program.
1403 (d) Involvement of stakeholders in achieving improved
1404 patient health care and safety and reduction of prescription
1405 drug abuse and prescription drug diversion.
1406 (9) Any person who willfully and knowingly fails to report
1407 the dispensing of a controlled substance as required by this
1408 section commits a misdemeanor of the first degree, punishable as
1409 provided in s. 775.082 or s. 775.083.
1410 (10) All costs incurred by the department in administering
1411 the prescription drug monitoring program shall be funded through
1412 federal grants or private funding applied for or received by the
1413 state. The department may not commit funds for the monitoring
1414 program without ensuring funding is available. The prescription
1415 drug monitoring program and the implementation thereof are
1416 contingent upon receipt of the nonstate funding. The department
1417 and state government shall cooperate with the direct-support
1418 organization established pursuant to subsection (11) in seeking
1419 federal grant funds, other nonstate grant funds, gifts,
1420 donations, or other private moneys for the department so long as
1421 the costs of doing so are not considered material. Nonmaterial
1422 costs for this purpose include, but are not limited to, the
1423 costs of mailing and personnel assigned to research or apply for
1424 a grant. Notwithstanding the exemptions to competitive
1425 solicitation requirements under s. 287.057(3)(f), the department
1426 shall comply with the competitive-solicitation requirements
1427 under s. 287.057 for the procurement of any goods or services
1428 required by this section.
1429 (11) The Office of Drug Control, in coordination with the
1430 department, may establish a direct-support organization that has
1431 a board consisting of at least five members to provide
1432 assistance, funding, and promotional support for the activities
1433 authorized for the prescription drug monitoring program.
1434 (a) As used in this subsection, the term “direct-support
1435 organization” means an organization that is:
1436 1. A Florida corporation not for profit incorporated under
1437 chapter 617, exempted from filing fees, and approved by the
1438 Department of State.
1439 2. Organized and operated to conduct programs and
1440 activities; raise funds; request and receive grants, gifts, and
1441 bequests of money; acquire, receive, hold, and invest, in its
1442 own name, securities, funds, objects of value, or other
1443 property, either real or personal; and make expenditures or
1444 provide funding to or for the direct or indirect benefit of the
1445 department in the furtherance of the prescription drug
1446 monitoring program.
1447 (b) The direct-support organization is not considered a
1448 lobbying firm within the meaning of s. 11.045.
1449 (c) The director of the Office of Drug Control shall
1450 appoint a board of directors for the direct-support
1451 organization. The director may designate employees of the Office
1452 of Drug Control, state employees other than state employees from
1453 the department, and any other nonstate employees as appropriate,
1454 to serve on the board. Members of the board shall serve at the
1455 pleasure of the director of the Office of Drug Control. The
1456 director shall provide guidance to members of the board to
1457 ensure that moneys received by the direct-support organization
1458 are not received from inappropriate sources. Inappropriate
1459 sources include, but are not limited to, donors, grantors,
1460 persons, or organizations that may monetarily or substantively
1461 benefit from the purchase of goods or services by the department
1462 in furtherance of the prescription drug monitoring program.
1463 (d) The direct-support organization shall operate under
1464 written contract with the Office of Drug Control. The contract
1465 must, at a minimum, provide for:
1466 1. Approval of the articles of incorporation and bylaws of
1467 the direct-support organization by the Office of Drug Control.
1468 2. Submission of an annual budget for the approval of the
1469 Office of Drug Control.
1470 3. Certification by the Office of Drug Control in
1471 consultation with the department that the direct-support
1472 organization is complying with the terms of the contract in a
1473 manner consistent with and in furtherance of the goals and
1474 purposes of the prescription drug monitoring program and in the
1475 best interests of the state. Such certification must be made
1476 annually and reported in the official minutes of a meeting of
1477 the direct-support organization.
1478 4. The reversion, without penalty, to the Office of Drug
1479 Control, or to the state if the Office of Drug Control ceases to
1480 exist, of all moneys and property held in trust by the direct
1481 support organization for the benefit of the prescription drug
1482 monitoring program if the direct-support organization ceases to
1483 exist or if the contract is terminated.
1484 5. The fiscal year of the direct-support organization,
1485 which must begin July 1 of each year and end June 30 of the
1486 following year.
1487 6. The disclosure of the material provisions of the
1488 contract to donors of gifts, contributions, or bequests,
1489 including such disclosure on all promotional and fundraising
1490 publications, and an explanation to such donors of the
1491 distinction between the Office of Drug Control and the direct
1492 support organization.
1493 7. The direct-support organization’s collecting, expending,
1494 and providing of funds to the department for the development,
1495 implementation, and operation of the prescription drug
1496 monitoring program as described in this section and s. 2,
1497 chapter 2009-198, Laws of Florida, as long as the task force is
1498 authorized. The direct-support organization may collect and
1499 expend funds to be used for the functions of the direct-support
1500 organization’s board of directors, as necessary and approved by
1501 the director of the Office of Drug Control. In addition, the
1502 direct-support organization may collect and provide funding to
1503 the department in furtherance of the prescription drug
1504 monitoring program by:
1505 a. Establishing and administering the prescription drug
1506 monitoring program’s electronic database, including hardware and
1507 software.
1508 b. Conducting studies on the efficiency and effectiveness
1509 of the program to include feasibility studies as described in
1510 subsection (13).
1511 c. Providing funds for future enhancements of the program
1512 within the intent of this section.
1513 d. Providing user training of the prescription drug
1514 monitoring program, including distribution of materials to
1515 promote public awareness and education and conducting workshops
1516 or other meetings, for health care practitioners, pharmacists,
1517 and others as appropriate.
1518 e. Providing funds for travel expenses.
1519 f. Providing funds for administrative costs, including
1520 personnel, audits, facilities, and equipment.
1521 g. Fulfilling all other requirements necessary to implement
1522 and operate the program as outlined in this section.
1523 (e) The activities of the direct-support organization must
1524 be consistent with the goals and mission of the Office of Drug
1525 Control, as determined by the office in consultation with the
1526 department, and in the best interests of the state. The direct
1527 support organization must obtain a written approval from the
1528 director of the Office of Drug Control for any activities in
1529 support of the prescription drug monitoring program before
1530 undertaking those activities.
1531 (f) The Office of Drug Control, in consultation with the
1532 department, may permit, without charge, appropriate use of
1533 administrative services, property, and facilities of the Office
1534 of Drug Control and the department by the direct-support
1535 organization, subject to this section. The use must be directly
1536 in keeping with the approved purposes of the direct-support
1537 organization and may not be made at times or places that would
1538 unreasonably interfere with opportunities for the public to use
1539 such facilities for established purposes. Any moneys received
1540 from rentals of facilities and properties managed by the Office
1541 of Drug Control and the department may be held by the Office of
1542 Drug Control or in a separate depository account in the name of
1543 the direct-support organization and subject to the provisions of
1544 the letter of agreement with the Office of Drug Control. The
1545 letter of agreement must provide that any funds held in the
1546 separate depository account in the name of the direct-support
1547 organization must revert to the Office of Drug Control if the
1548 direct-support organization is no longer approved by the Office
1549 of Drug Control to operate in the best interests of the state.
1550 (g) The Office of Drug Control, in consultation with the
1551 department, may adopt rules under s. 120.54 to govern the use of
1552 administrative services, property, or facilities of the
1553 department or office by the direct-support organization.
1554 (h) The Office of Drug Control may not permit the use of
1555 any administrative services, property, or facilities of the
1556 state by a direct-support organization if that organization does
1557 not provide equal membership and employment opportunities to all
1558 persons regardless of race, color, religion, gender, age, or
1559 national origin.
1560 (i) The direct-support organization shall provide for an
1561 independent annual financial audit in accordance with s.
1562 215.981. Copies of the audit shall be provided to the Office of
1563 Drug Control and the Office of Policy and Budget in the
1564 Executive Office of the Governor.
1565 (j) The direct-support organization may not exercise any
1566 power under s. 617.0302(12) or (16).
1567 (12) A prescriber or dispenser may have access to the
1568 information under this section which relates to a patient of
1569 that prescriber or dispenser as needed for the purpose of
1570 reviewing the patient’s controlled drug prescription history. A
1571 prescriber or dispenser acting in good faith is immune from any
1572 civil, criminal, or administrative liability that might
1573 otherwise be incurred or imposed for receiving or using
1574 information from the prescription drug monitoring program. This
1575 subsection does not create a private cause of action, and a
1576 person may not recover damages against a prescriber or dispenser
1577 authorized to access information under this subsection for
1578 accessing or failing to access such information.
1579 (13) To the extent that funding is provided for such
1580 purpose through federal or private grants or gifts and other
1581 types of available moneys, the department, in collaboration with
1582 the Office of Drug Control, shall study the feasibility of
1583 enhancing the prescription drug monitoring program for the
1584 purposes of public health initiatives and statistical reporting
1585 that respects the privacy of the patient, the prescriber, and
1586 the dispenser. Such a study shall be conducted in order to
1587 further improve the quality of health care services and safety
1588 by improving the prescribing and dispensing practices for
1589 prescription drugs, taking advantage of advances in technology,
1590 reducing duplicative prescriptions and the overprescribing of
1591 prescription drugs, and reducing drug abuse. The requirements of
1592 the National All Schedules Prescription Electronic Reporting
1593 (NASPER) Act are authorized in order to apply for federal NASPER
1594 funding. In addition, the direct-support organization shall
1595 provide funding for the department, in collaboration with the
1596 Office of Drug Control, to conduct training for health care
1597 practitioners and other appropriate persons in using the
1598 monitoring program to support the program enhancements.
1599 (14) A pharmacist, pharmacy, or dispensing health care
1600 practitioner or his or her agent, before releasing a controlled
1601 substance to any person not known to such dispenser, shall
1602 require the person purchasing, receiving, or otherwise acquiring
1603 the controlled substance to present valid photographic
1604 identification or other verification of his or her identity to
1605 the dispenser. If the person does not have proper
1606 identification, the dispenser may verify the validity of the
1607 prescription and the identity of the patient with the prescriber
1608 or his or her authorized agent. Verification of health plan
1609 eligibility through a real-time inquiry or adjudication system
1610 will be considered to be proper identification. This subsection
1611 does not apply in an institutional setting or to a long-term
1612 care facility, including, but not limited to, an assisted living
1613 facility or a hospital to which patients are admitted. As used
1614 in this subsection, the term “proper identification” means an
1615 identification that is issued by a state or the Federal
1616 Government containing the person’s photograph, printed name, and
1617 signature or a document considered acceptable under 8 C.F.R. s.
1618 274a.2(b)(1)(v)(A) and (B).
1619 (15) The Agency for Health Care Administration shall
1620 continue the promotion of electronic prescribing by health care
1621 practitioners, health care facilities, and pharmacies under s.
1622 408.0611.
1623 (16) By October 1, 2010, the department shall adopt rules
1624 pursuant to ss. 120.536(1) and 120.54 to administer the
1625 provisions of this section, which shall include as necessary the
1626 reporting, accessing, evaluation, management, development,
1627 implementation, operation, and storage of information within the
1628 monitoring program’s system.
1629 (17) After the prescription drug monitoring program has
1630 been operational for 12 months, the State Surgeon General shall
1631 enter into reciprocal agreements for the sharing of prescription
1632 drug monitoring information with any other state that has a
1633 compatible prescription drug monitoring program. If the State
1634 Surgeon General evaluates the prescription drug monitoring
1635 program of another state as authorized in this subsection,
1636 priority shall be given to a state that is contiguous with the
1637 borders of this state.
1638 (a) In determining compatibility, the State Surgeon General
1639 shall consider:
1640 1. The essential purposes of the program and the success of
1641 the program in fulfilling those purposes.
1642 2. The safeguards for privacy of patient records and the
1643 success of the program in protecting patient privacy.
1644 3. The persons authorized to view the data collected by the
1645 program. Comparable organizations and professions for
1646 practitioners in other states, law enforcement agencies, the
1647 Attorney General’s Medicaid Fraud Unit, medical regulatory
1648 boards, and, as needed, management staff who have similar duties
1649 as management staff who work with the prescription drug
1650 monitoring program as authorized in s. 893.0551 are authorized
1651 access upon approval by the State Surgeon General.
1652 4. The schedules of the controlled substances that are
1653 monitored.
1654 5. The data required to be submitted for each prescription.
1655 6. Any implementing criteria deemed essential for a
1656 thorough comparison.
1657 (b) The State Surgeon General shall annually review any
1658 agreement to determine its continued compatibility with the
1659 prescription drug monitoring program in this state.
1660 (c) Any agreement between the State Surgeon General and
1661 another state shall prohibit the sharing of information
1662 concerning a resident of this state or a practitioner,
1663 pharmacist, or other prescriber for any purpose that is not
1664 otherwise authorized by this section or s. 893.0551.
1665 Section 22. Present subsections (4), (5), (6), and (7) of
1666 section 893.0551, Florida Statutes, are redesignated as
1667 subsections (5), (6), (7), and (8), respectively, and a new
1668 subsection (4) is added to that section, to read:
1669 893.0551 Public records exemption for the prescription drug
1670 monitoring program.—
1671 (4) The department may disclose confidential and exempt
1672 information contained in records held by the department under s.
1673 893.055 if the State Surgeon General has entered into a
1674 reciprocal agreement for the sharing of prescription drug
1675 monitoring information with any other state that has a
1676 compatible prescription drug monitoring program.
1677 (a) The reciprocal agreement may allow the following
1678 persons from another state to receive information from the
1679 prescription drug monitoring program if approved by the State
1680 Surgeon General:
1681 1. A designated representative of a state professional
1682 licensing, certification, or regulatory agency charged with
1683 oversight of those persons authorized to prescribe or dispense
1684 controlled substances for the purpose of a bona fide, specific
1685 investigation of a prescription of a controlled substance which
1686 involves a designated person. As required in s. 893.055, this
1687 authorization does not preclude the requirement for the program
1688 manager to review the request for information and validate it.
1689 2. A health care practitioner or pharmacist licensed in the
1690 state from which the request originates. Such health care
1691 practitioner or pharmacist shall certify that the requested
1692 information is for the purpose of providing medical or
1693 pharmaceutical treatment to a bona fide, current patient. The
1694 health care practitioner or pharmacist shall follow all the
1695 procedures required in s. 893.055 and rules established by the
1696 department for a health care practitioner or pharmacist to
1697 request information from the database.
1698 3. A law enforcement officer from another state:
1699 a. Who is a member of a sheriff’s department or a police
1700 department;
1701 b. Who is authorized by law to conduct criminal
1702 investigations and make arrests;
1703 c. Whose duty it is to enforce the laws of his or her state
1704 relating to controlled substances; and
1705 d. Who is engaged in a bona fide specific, active
1706 investigation involving a designated person regarding
1707 prescriptions for controlled substances.
1708
1709 As required in s. 893.055, this authorization does not preclude
1710 the requirement for the program manager to review the request
1711 for information and validate it. This authorization also does
1712 not preclude the ability to provide a report to a law
1713 enforcement agency in another state under s. 893.055(7) or this
1714 subsection.
1715 (b) Any agreement between the State Surgeon General and
1716 another state shall prohibit the sharing of information
1717 concerning a resident of this state, a patient whose information
1718 is in the program’s database, or a practitioner, pharmacy,
1719 pharmacist, health care practitioner, or other prescriber for
1720 any purpose that is not otherwise authorized by this section or
1721 s. 893.055, and the information must be provided according to
1722 the State Surgeon General’s determination of compatibility as
1723 described in s. 893.055(17).
1724 Section 23. Subsections (1), (4), and (5) of section
1725 893.07, Florida Statutes, are amended, and subsection (6) is
1726 added to that section, to read:
1727 893.07 Records.—
1728 (1) Notwithstanding any other provision of law and in
1729 consonance with the authority of State v. Carter, 23 So. 3d 798
1730 (Fla. 1st DCA 2009) and State v. Tamulonis, 39 So. 3d 524 (Fla.
1731 2nd DCA 2010), every person who engages in the manufacture,
1732 compounding, mixing, cultivating, growing, or by any other
1733 process producing or preparing, or in the dispensing,
1734 importation, or, as a wholesaler, distribution, of controlled
1735 substances shall:
1736 (a) On January 1, 1974, or as soon thereafter as any person
1737 first engages in such activity, and every second year
1738 thereafter, make a complete and accurate record of all stocks of
1739 controlled substances on hand. The inventory may be prepared on
1740 the regular physical inventory date which is nearest to, and
1741 does not vary by more than 6 months from, the biennial date that
1742 would otherwise apply. As additional substances are designated
1743 for control under this chapter, they shall be inventoried as
1744 provided for in this subsection.
1745 (b) On and after January 1, 1974, maintain, on a current
1746 basis, a complete and accurate record of each substance
1747 manufactured, received, sold, delivered, or otherwise disposed
1748 of by him or her, except that this subsection shall not require
1749 the maintenance of a perpetual inventory.
1750
1751 Compliance with the provisions of federal law pertaining to the
1752 keeping of records of controlled substances shall be deemed a
1753 compliance with the requirements of this subsection.
1754 (4) Every inventory or record required by this chapter,
1755 including prescription records, shall be maintained:
1756 (a) Separately from all other records of the registrant, or
1757 (b) Alternatively, in the case of Schedule III, IV, or V
1758 controlled substances, in such form that information required by
1759 this chapter is readily retrievable from the ordinary business
1760 records of the registrant.
1761
1762 In either case, such records described in this subsection shall
1763 be kept and made available for a period of at least 2 years for
1764 inspection and copying by law enforcement officers whose duty it
1765 is to enforce the laws of this state relating to controlled
1766 substances. This subsection does not require a law enforcement
1767 officer to obtain a subpoena, court order, or search warrant in
1768 order to obtain access to or copies of such records.
1769 (5) Each person shall maintain a record that contains which
1770 shall contain a detailed list of controlled substances lost,
1771 destroyed, or stolen, if any; the kind and quantity of such
1772 controlled substances; and the date of the discovering of such
1773 loss, destruction, or theft. If a person discovers the theft or
1774 loss of a controlled substance, such person shall report the
1775 theft or loss to a local county sheriff’s office within 48 hours
1776 after the discovery of such theft or loss. A person who fails to
1777 report the theft or loss of a controlled substance under this
1778 subsection commits a misdemeanor of the second degree,
1779 punishable as provided in s. 775.082 or s. 775.083. However, a
1780 person who fails to report the theft or loss of a Schedule II
1781 controlled substance commits a misdemeanor of the first degree,
1782 punishable as provided in s. 775.082 or s. 775.083.
1783 (6) The Legislature finds that the opinions rendered in
1784 State v. Carter, 23 So. 3d 798 (Fla. 1st DCA 2009), and State v.
1785 Tamulonis, 39 So. 3d 524 (Fla. 2nd DCA 2010), correctly construe
1786 this Legislature’s intent that the inspection powers previously
1787 conferred upon law enforcement officers which allow such
1788 officers to access and review pharmacy records concerning
1789 controlled substances are to be exercised properly by such law
1790 enforcement officers without the requirement of a subpoena or
1791 search warrant being sought or issued to examine and copy such
1792 records, and without the requirement that those persons to whom
1793 particular pharmacy records refer be given notice of the
1794 records’ examination and copying under this section.
1795 Section 24. Subsections (7) and (8) of section 893.13,
1796 Florida Statutes, are amended to read:
1797 893.13 Prohibited acts; penalties.—
1798 (7)(a) A It is unlawful for any person may not:
1799 1. To Distribute or dispense a controlled substance in
1800 violation of this chapter.
1801 2. To Refuse or fail to make, keep, or furnish any record,
1802 notification, order form, statement, invoice, or information
1803 required under this chapter.
1804 3. To Refuse an entry into any premises for any inspection
1805 or to refuse to allow any inspection authorized by this chapter.
1806 4. To Distribute a controlled substance named or described
1807 in s. 893.03(1) or (2) except pursuant to an order form as
1808 required by s. 893.06.
1809 5. To Keep or maintain any store, shop, warehouse,
1810 dwelling, building, vehicle, boat, aircraft, or other structure
1811 or place which is resorted to by persons using controlled
1812 substances in violation of this chapter for the purpose of using
1813 these substances, or which is used for keeping or selling them
1814 in violation of this chapter.
1815 6. To Use to his or her own personal advantage, or to
1816 reveal, any information obtained in enforcement of this chapter
1817 except in a prosecution or administrative hearing for a
1818 violation of this chapter.
1819 7. To Possess a prescription form which has not been
1820 completed and signed by the practitioner whose name appears
1821 printed thereon, unless the person is that practitioner, is an
1822 agent or employee of that practitioner, is a pharmacist, or is a
1823 supplier of prescription forms who is authorized by that
1824 practitioner to possess those forms.
1825 8. To Withhold information from a practitioner from whom
1826 the person seeks to obtain a controlled substance or a
1827 prescription for a controlled substance that the person making
1828 the request has received a controlled substance or a
1829 prescription for a controlled substance of like therapeutic use
1830 from another practitioner within the previous 30 days.
1831 9. To Acquire or obtain, or attempt to acquire or obtain,
1832 possession of a controlled substance by misrepresentation,
1833 fraud, forgery, deception, or subterfuge.
1834 10. To Affix any false or forged label to a package or
1835 receptacle containing a controlled substance.
1836 11. To Furnish false or fraudulent material information in,
1837 or omit any material information from, any report or other
1838 document required to be kept or filed under this chapter or any
1839 record required to be kept by this chapter.
1840 12. To Store anhydrous ammonia in a container that is not
1841 approved by the United States Department of Transportation to
1842 hold anhydrous ammonia or is not constructed in accordance with
1843 sound engineering, agricultural, or commercial practices.
1844 13. With the intent to obtain a controlled substance or
1845 combination of controlled substances that are not medically
1846 necessary for the person or an amount of a controlled substance
1847 or substances that are not medically necessary for the person,
1848 obtain or attempt to obtain from a practitioner a controlled
1849 substance or a prescription for a controlled substance by
1850 misrepresentation, fraud, forgery, deception, subterfuge, or
1851 concealment of a material fact. For purposes of this
1852 subparagraph, a material fact includes whether the person has an
1853 existing prescription for a controlled substance issued for the
1854 same period of time by another practitioner or as described in
1855 subparagraph 8.
1856 (b) A health care practitioner, with the intent to provide
1857 a controlled substance or combination of controlled substances
1858 that are not medically necessary to his or her patient or an
1859 amount of controlled substances that are not medically necessary
1860 for his or her patient, may not provide a controlled substance
1861 or a prescription for a controlled substance by
1862 misrepresentation, fraud, forgery, deception, subterfuge, or
1863 concealment of a material fact. For purposes of this paragraph,
1864 a material fact includes whether the patient has an existing
1865 prescription for a controlled substance issued for the same
1866 period of time by another practitioner or as described in
1867 subparagraph (a)8.
1868 (c) Any person who adulterates a controlled substance for
1869 directed off-label use without authorization by a prescribing
1870 physician violates the provisions of subparagraph (a)1. and
1871 causes the issuance of the entire prescription for the
1872 controlled substance to become invalid. A law enforcement
1873 officer in the performance of his or her official duties may
1874 seize the adulterated or off-label prescribed controlled
1875 substance as evidence. The controlled substance may be returned
1876 to the owner only with a notarized affidavit from the original
1877 prescribing practitioner who has knowledge and gave
1878 authorization and explicit directions for the adulteration or
1879 off-label use of the controlled substance.
1880 (d)(b) Any person who violates the provisions of
1881 subparagraphs (a)1.-7. commits a misdemeanor of the first
1882 degree, punishable as provided in s. 775.082 or s. 775.083;
1883 except that, upon a second or subsequent violation, the person
1884 commits a felony of the third degree, punishable as provided in
1885 s. 775.082, s. 775.083, or s. 775.084.
1886 (e)(c) Any person who violates the provisions of
1887 subparagraphs (a)8.-12. commits a felony of the third degree,
1888 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
1889 (f) A person or health care practitioner who violates the
1890 provisions of paragraph (b) or subparagraph (a)13. commits a
1891 felony of the third degree, punishable as provided in s.
1892 775.082, s. 775.083, or s. 775.084, if any controlled substance
1893 that is the subject of the offense is listed in Schedule II,
1894 Schedule III, or Schedule IV.
1895 (8)(a) Notwithstanding subsection (9), a prescribing
1896 practitioner may not:
1897 1. Knowingly assist a patient, other person, or the owner
1898 of an animal in obtaining a controlled substance through
1899 deceptive, untrue, or fraudulent representations in or related
1900 to the practice of the prescribing practitioner’s professional
1901 practice;
1902 2. Employ a trick or scheme in the practice of the
1903 prescribing practitioner’s professional practice to assist a
1904 patient, other person, or the owner of an animal in obtaining a
1905 controlled substance;
1906 3. Knowingly write a prescription for a controlled
1907 substance for a fictitious person; or
1908 4. Write a prescription for a controlled substance for a
1909 patient, other person, or an animal if the sole purpose of
1910 writing such prescription is to provide a monetary benefit to,
1911 or obtain a monetary benefit for, the prescribing practitioner;
1912 or.
1913 5. Write a prescription for a controlled substance for a
1914 patient, other person, or an animal and authorize or direct the
1915 adulteration of the dispensed form of the controlled substance
1916 for the purpose of ingestion by means of inhalation, injection,
1917 or any other means not medically necessary for the treatment of
1918 the patient.
1919 (b) If the prescribing practitioner wrote a prescription or
1920 multiple prescriptions for a controlled substance for the
1921 patient, other person, or animal for which there was no medical
1922 necessity, or which was in excess of what was medically
1923 necessary to treat the patient, other person, or animal, that
1924 fact does not give rise to any presumption that the prescribing
1925 practitioner violated subparagraph (a)1., but may be considered
1926 with other competent evidence in determining whether the
1927 prescribing practitioner knowingly assisted a patient, other
1928 person, or the owner of an animal to obtain a controlled
1929 substance in violation of subparagraph (a)1.
1930 (c) A person who violates paragraph (a) commits a felony of
1931 the third degree, punishable as provided in s. 775.082, s.
1932 775.083, or s. 775.084.
1933 (d) Notwithstanding paragraph (c), if a prescribing
1934 practitioner has violated paragraph (a) and received $1,000 or
1935 more in payment for writing one or more prescriptions or, in the
1936 case of a prescription written for a controlled substance
1937 described in s. 893.135, has written one or more prescriptions
1938 for a quantity of a controlled substance which, individually or
1939 in the aggregate, meets the threshold for the offense of
1940 trafficking in a controlled substance under s. 893.15, the
1941 violation is reclassified as a felony of the second degree and
1942 ranked in level 4 of the Criminal Punishment Code.
1943 Section 25. Present subsections (3) through (10) of section
1944 893.138, Florida Statutes, are redesignated as subsections (4)
1945 through (11), respectively, and a new subsection (3) is added to
1946 that section, to read:
1947 893.138 Local administrative action to abate drug-related,
1948 prostitution-related, or stolen-property-related public
1949 nuisances and criminal gang activity.—
1950 (3) Any pain-management clinic, as described in s. 458.3265
1951 or s. 459.0137, which has been used on more than two occasions
1952 within a 6-month period as the site of a violation of:
1953 (a) Section 784.011, s. 784.021, s. 784.03, or s. 784.045,
1954 relating to assault and battery;
1955 (b) Section 810.02, relating to burglary;
1956 (c) Section 812.014, relating to dealing in theft;
1957 (d) Section 812.131, relating to robbery by sudden
1958 snatching; or
1959 (e) Section 893.13, relating to the unlawful distribution
1960 of controlled substances,
1961
1962 may be declared to be a public nuisance, and such nuisance may
1963 be abated pursuant to the procedures provided in this section.
1964 Section 26. (1) DEFINITIONS.—As used in this section, the
1965 term:
1966 (a) “Interchange or substitution of an opioid analgesic
1967 drug” means the substitution of any opioid analgesic drug, brand
1968 or generic, for the opioid analgesic drug incorporating a
1969 tamper-resistance technology originally prescribed, irrespective
1970 of whether the substituted drug is rated as pharmaceutically and
1971 therapeutically equivalent by the United States Food and Drug
1972 Administration or the Board of Pharmacy or whether the opioid
1973 analgesic drug with tamper-resistance technology bears a
1974 labeling claim with respect to reduction of tampering, abuse, or
1975 abuse potential.
1976 (b) “Opioid analgesic drug” means a drug in the opioid
1977 analgesic drug class prescribed to treat moderate to severe pain
1978 or other conditions, whether in immediate release or extended
1979 release form and whether or not combined with other drug
1980 substances to form a single tablet or other dosage form.
1981 (c) “Opioid analgesic drug incorporating a tamper
1982 resistance technology” means an opioid analgesic drug listed as
1983 such by the Board of Pharmacy based on a submission of evidence
1984 by the drug manufacturer or distributor that the drug:
1985 1. Incorporates a tamper-resistance technology; and
1986 2. Has been approved by the United States Food and Drug
1987 Administration pursuant to an application that includes at least
1988 one study on human tampering or abuse potential or a laboratory
1989 study comparing the tamper- or abuse-resistance properties of
1990 the drug to one or more opioid analgesic drugs that:
1991 a. Have been approved by the United States Food and Drug
1992 Administration; and
1993 b. Serve as a positive control.
1994 (d) “Pharmacist” means any person licensed under chapter
1995 465, Florida Statutes, to practice the profession of pharmacy,
1996 including, but not limited to, a community pharmacist and a
1997 pharmacist in a hospital-based pharmacy, when filling
1998 prescriptions for inpatient or outpatient care.
1999 (2) LIST OF OPIOID ANALGESIC DRUGS INCORPORATING A TAMPER
2000 RESISTANCE TECHNOLOGY.—The Board of Pharmacy shall create a list
2001 of opioid analgesic drugs for which information has been
2002 submitted consistent with paragraph (1)(c). Inclusion of a drug
2003 on such list does not require that the drug bear a labeling
2004 claim with respect to reduction of tampering, abuse, or abuse
2005 potential at the time of listing. Such list must also include a
2006 determination by the Board of Pharmacy as to which listed opioid
2007 analgesic drugs incorporating tamper-resistance technologies
2008 provide substantially similar tamper-resistance properties,
2009 based solely on studies submitted by the drug manufacturer
2010 consistent with paragraph (1)(c).
2011 (3) PROHIBITION.—Notwithstanding s. 465.025, Florida
2012 Statutes, a pharmacist may not interchange or substitute an
2013 opioid analgesic drug, brand or generic, for an opioid analgesic
2014 drug incorporating a tamper-resistance technology which is
2015 listed pursuant to subsection (2) without:
2016 (a) Verifying that the opioid analgesic drug has been
2017 listed by the Board of Pharmacy under subsection (2) as
2018 providing tamper-resistance properties substantially similar to
2019 the prescribed opioid analgesic drug incorporating a tamper
2020 resistance technology; or
2021 (b) Obtaining written, signed consent from the prescribing
2022 physician for such interchange or substitution.
2023 Section 27. This act shall take effect October 1, 2011.