Florida Senate - 2011 CS for CS for SB 818
By the Committees on Criminal Justice; and Health Regulation;
and Senator Fasano
591-02844-11 2011818c2
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 licensed pharmacist or
99 other person employed by or at a pharmacy is not
100 subject to disciplinary action for reporting; amending
101 s. 465.0276, F.S.; requiring a practitioner to
102 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.; requiring the Department of Health to
174 disclose confidential and exempt information
175 pertaining to the prescription drug monitoring program
176 to the Attorney General and designee when working on
177 Medicaid fraud cases and Medicaid investigations
178 involving prescribed controlled substances or when the
179 Attorney General has initiated a review of specific
180 identifiers that warrant a Medicaid investigation
181 regarding prescribed controlled substances;
182 prohibiting the Attorney General’s Medicaid
183 investigators from direct access to the prescription
184 drug monitoring program’s database; authorizing the
185 Department of Health to disclose certain confidential
186 and exempt information in the prescription drug
187 monitoring program’s database under certain
188 circumstances involving reciprocal agreements with
189 other states; prohibiting the sharing of information
190 from the prescription drug monitoring program’s
191 database which is not for the purpose that is
192 statutorily authorized or according to the State
193 Surgeon General’s determination of compatibility;
194 amending s. 893.07, F.S.; requiring that a person
195 report to the local sheriff’s office the theft or loss
196 of a controlled substance within a specified time;
197 providing penalties; providing legislative intent;
198 amending s. 893.13, F.S.; prohibiting a person from
199 obtaining or attempting to obtain from a practitioner
200 a controlled substance or a prescription for a
201 controlled substance by misrepresentation, fraud,
202 forgery, deception, subterfuge, or concealment of a
203 material fact; prohibiting a health care provider from
204 providing a controlled substance or a prescription for
205 a controlled substance by misrepresentation, fraud,
206 forgery, deception, subterfuge, or concealment of a
207 material fact; prohibiting a person from adulterating
208 a controlled substance for certain use without
209 authorization by a prescribing physician; authorizing
210 a law enforcement officer to seize as evidence the
211 adulteration or off-label use of a prescribed
212 controlled substance; providing that such adulterated
213 or off-label use of the controlled substance may be
214 returned to its owner only under certain conditions;
215 providing penalties; prohibiting a prescribing
216 practitioner from writing a prescription for a
217 controlled substance and authorizing or directing the
218 adulteration of the dispensed form of the controlled
219 substance for the purpose of ingestion by means not
220 medically necessary; amending s. 893.138, F.S.;
221 providing circumstances in which a pain-management
222 clinic may be declared a public nuisance; providing
223 definitions; requiring the Board of Pharmacy to create
224 a list of opioid analgesic drugs; providing
225 requirements for the list of opioid analgesic drugs;
226 providing an effective date.
227
228 Be It Enacted by the Legislature of the State of Florida:
229
230 Section 1. Subsections (4) and (7) of section 400.9905,
231 Florida Statutes, are amended to read:
232 400.9905 Definitions.—
233 (4) “Clinic” means an entity at which health care services
234 are provided to individuals and which tenders charges for
235 reimbursement or payment for such services, including a mobile
236 clinic and a portable equipment provider. For purposes of this
237 part, the term does not include and the licensure requirements
238 of this part do not apply to:
239 (a) Entities licensed or registered by the state under
240 chapter 395; or entities licensed or registered by the state and
241 providing only health care services within the scope of services
242 authorized under their respective licenses granted under ss.
243 383.30-383.335, chapter 390, chapter 394, chapter 397, this
244 chapter except part X, chapter 429, chapter 463, chapter 465,
245 chapter 466, chapter 478, part I of chapter 483, chapter 484, or
246 chapter 651; end-stage renal disease providers authorized under
247 42 C.F.R. part 405, subpart U; or providers certified under 42
248 C.F.R. part 485, subpart B or subpart H; or any entity that
249 provides neonatal or pediatric hospital-based health care
250 services or other health care services by licensed practitioners
251 solely within a hospital licensed under chapter 395.
252 (b) Entities that own, directly or indirectly, entities
253 licensed or registered by the state pursuant to chapter 395; or
254 entities that own, directly or indirectly, entities licensed or
255 registered by the state and providing only health care services
256 within the scope of services authorized pursuant to their
257 respective licenses granted under ss. 383.30-383.335, chapter
258 390, chapter 394, chapter 397, this chapter except part X,
259 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
260 part I of chapter 483, chapter 484, chapter 651; end-stage renal
261 disease providers authorized under 42 C.F.R. part 405, subpart
262 U; or providers certified under 42 C.F.R. part 485, subpart B or
263 subpart H; or any entity that provides neonatal or pediatric
264 hospital-based health care services by licensed practitioners
265 solely within a hospital licensed under chapter 395.
266 (c) Entities that are owned, directly or indirectly, by an
267 entity licensed or registered by the state pursuant to chapter
268 395; or entities that are owned, directly or indirectly, by an
269 entity licensed or registered by the state and providing only
270 health care services within the scope of services authorized
271 pursuant to their respective licenses granted under ss. 383.30
272 383.335, chapter 390, chapter 394, chapter 397, this chapter
273 except part X, chapter 429, chapter 463, chapter 465, chapter
274 466, chapter 478, part I of chapter 483, chapter 484, or chapter
275 651; end-stage renal disease providers authorized under 42
276 C.F.R. part 405, subpart U; or providers certified under 42
277 C.F.R. part 485, subpart B or subpart H; or any entity that
278 provides neonatal or pediatric hospital-based health care
279 services by licensed practitioners solely within a hospital
280 under chapter 395.
281 (d) Entities that are under common ownership, directly or
282 indirectly, with an entity licensed or registered by the state
283 pursuant to chapter 395; or entities that are under common
284 ownership, directly or indirectly, with an entity licensed or
285 registered by the state and providing only health care services
286 within the scope of services authorized pursuant to their
287 respective licenses granted under ss. 383.30-383.335, chapter
288 390, chapter 394, chapter 397, this chapter except part X,
289 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
290 part I of chapter 483, chapter 484, or chapter 651; end-stage
291 renal disease providers authorized under 42 C.F.R. part 405,
292 subpart U; or providers certified under 42 C.F.R. part 485,
293 subpart B or subpart H; or any entity that provides neonatal or
294 pediatric hospital-based health care services by licensed
295 practitioners solely within a hospital licensed under chapter
296 395.
297 (e) An entity that is exempt from federal taxation under 26
298 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan
299 under 26 U.S.C. s. 409 that has a board of trustees not less
300 than two-thirds of which are Florida-licensed health care
301 practitioners and provides only physical therapy services under
302 physician orders, any community college or university clinic,
303 and any entity owned or operated by the federal or state
304 government, including agencies, subdivisions, or municipalities
305 thereof.
306 (f) A sole proprietorship, group practice, partnership, or
307 corporation that provides health care services by physicians
308 covered by s. 627.419, that is directly supervised by one or
309 more of such physicians, and that is wholly owned by one or more
310 of those physicians or by a physician and the spouse, parent,
311 child, or sibling of that physician.
312 (g) A sole proprietorship, group practice, partnership, or
313 corporation that provides health care services by licensed
314 health care practitioners under chapter 457, chapter 458,
315 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
316 chapter 466, chapter 467, chapter 480, chapter 484, chapter 486,
317 chapter 490, chapter 491, or part I, part III, part X, part
318 XIII, or part XIV of chapter 468, or s. 464.012, which are
319 wholly owned by one or more licensed health care practitioners,
320 or the licensed health care practitioners set forth in this
321 paragraph and the spouse, parent, child, or sibling of a
322 licensed health care practitioner, so long as one of the owners
323 who is a licensed health care practitioner is supervising the
324 business activities and is legally responsible for the entity’s
325 compliance with all federal and state laws. However, a health
326 care practitioner may not supervise services beyond the scope of
327 the practitioner’s license, except that, for the purposes of
328 this part, a clinic owned by a licensee in s. 456.053(3)(b) that
329 provides only services authorized pursuant to s. 456.053(3)(b)
330 may be supervised by a licensee specified in s. 456.053(3)(b).
331 (h) Clinical facilities affiliated with an accredited
332 medical school at which training is provided for medical
333 students, residents, or fellows.
334 (i) Entities that provide only oncology or radiation
335 therapy services by physicians licensed under chapter 458 or
336 chapter 459 or entities that provide oncology or radiation
337 therapy services by physicians licensed under chapter 458 or
338 chapter 459 which are owned by a corporation whose shares are
339 publicly traded on a recognized stock exchange.
340 (j) Clinical facilities affiliated with a college of
341 chiropractic accredited by the Council on Chiropractic Education
342 at which training is provided for chiropractic students.
343 (k) Entities that provide licensed practitioners to staff
344 emergency departments or to deliver anesthesia services in
345 facilities licensed under chapter 395 and that derive at least
346 90 percent of their gross annual revenues from the provision of
347 such services. Entities claiming an exemption from licensure
348 under this paragraph must provide documentation demonstrating
349 compliance.
350 (l) Orthotic or prosthetic clinical facilities that are a
351 publicly traded corporation or that are wholly owned, directly
352 or indirectly, by a publicly traded corporation. As used in this
353 paragraph, a publicly traded corporation is a corporation that
354 issues securities traded on an exchange registered with the
355 United States Securities and Exchange Commission as a national
356 securities exchange.
357 (7) “Portable equipment provider” means an entity that
358 contracts with or employs persons to provide portable equipment
359 to multiple locations performing treatment or diagnostic testing
360 of individuals, that bills third-party payors for those
361 services, and that otherwise meets the definition of a clinic in
362 subsection (4).
363 Section 2. Subsection (7) of section 456.013, Florida
364 Statutes, is amended to read:
365 456.013 Department; general licensing provisions.—
366 (7)(a) The boards, or the department when there is no
367 board, shall require the completion of a 2-hour course relating
368 to prevention of medical errors as part of the licensure and
369 renewal process. The 2-hour course counts shall count towards
370 the total number of continuing education hours required for the
371 profession. The board or department shall approve the course
372 shall be approved by the board or department, as appropriate,
373 which must and shall include a study of root-cause analysis,
374 error reduction and prevention, and patient safety. In addition,
375 the course approved by the Board of Medicine and the Board of
376 Osteopathic Medicine must shall include information relating to
377 the five most misdiagnosed conditions during the previous
378 biennium, as determined by the board. If the course is being
379 offered by a facility licensed under pursuant to chapter 395 for
380 its employees, the board may approve up to 1 hour of the 2-hour
381 course to be specifically related to error reduction and
382 prevention methods used in that facility.
383 (b) As a condition of initial licensure and at each
384 subsequent license renewal, the boards, or the department if
385 there is no board, shall allow each practitioner licensed under
386 chapter 458, chapter 459, chapter 461, chapter 465, or chapter
387 466 whose lawful scope of practice authorizes the practitioner
388 to prescribe, administer, or dispense controlled substances to
389 complete a 1-hour continuing education course relating to the
390 prescription drug monitoring program. The course must include,
391 but need not be limited to:
392 1. The purpose of the prescription drug monitoring program.
393 2. The practitioners’ capabilities for improving the
394 standard of care for patients by using the prescription drug
395 monitoring program.
396 3. How the prescription drug monitoring program can help
397 practitioners detect doctor shopping.
398 4. The involvement of law enforcement personnel, the
399 Attorney General’s Medicaid Fraud Unit, and medical regulatory
400 investigators with the prescription drug monitoring program.
401 5. The procedures for registering for access to the
402 prescription drug monitoring program.
403
404 The course hours may be included in the total number of hours of
405 continuing education required by the profession and must be
406 approved by the board or by the department if there is no board.
407 The boards, or the department if there is no board, shall
408 approve the course offered through a facility licensed under
409 chapter 395 for its employees if the course is at least 3 hours
410 and covers the education requirements.
411 (c) The course requirements in paragraph (b) apply to each
412 licensee renewing his or her license on or after July 1, 2012,
413 and to each applicant approved for licensure on or after January
414 1, 2013.
415 (d) By October 1, 2011, the boards, or the department if
416 there is no board, shall adopt rules as necessary to administer
417 this subsection.
418 Section 3. Section 458.305, Florida Statutes, is amended to
419 read:
420 458.305 Definitions.—As used in this chapter:
421 (1) “Board” means the Board of Medicine.
422 (2) “Department” means the Department of Health.
423 (3) “Dispensing physician” means a physician who is
424 registered as a dispensing practitioner under s. 465.0276.
425 (4)(3) “Practice of medicine” means the diagnosis,
426 treatment, operation, or prescription for any human disease,
427 pain, injury, deformity, or other physical or mental condition.
428 (5)(4) “Physician” means a person who is licensed to
429 practice medicine in this state.
430 Section 4. Advertising of controlled substances by a
431 dispensing physician.—
432 (1)(a) Only a dispensing physician licensed under chapter
433 458 or chapter 459, Florida Statutes, may use the title
434 “dispensing physician” or “dispenser” or otherwise lead the
435 public to believe that he or she is engaged in the dispensing of
436 controlled substances.
437 (b) A person, other than an owner of a:
438 1. Pain-management clinic registered under chapter 458 or
439 chapter 459, Florida Statutes; or
440 2. Health clinic licensed under chapter 400, Florida
441 Statutes,
442
443 may not display any sign or take any other action that would
444 lead the public to believe that such person is engaged in the
445 business of dispensing a controlled substance. Any advertisement
446 that states “dispensing onsite” or “onsite pharmacy” violates
447 this paragraph. This paragraph does not preclude a person who is
448 not licensed as a medical practitioner from owning a pain
449 management clinic.
450 (c) A person, firm, or corporation, unless licensed under
451 chapter 465, Florida Statutes, may not use in a trade name,
452 sign, letter, or advertisement any term, including “drug,”
453 “pharmacy,” “onsite pharmacy,” “dispensing,” “dispensing
454 onsite,” “prescription drugs,” “Rx,” or “apothecary,” which
455 implies that the person, firm, or corporation is licensed or
456 registered to dispense prescription drugs in this state.
457 (2) A person who violates paragraph (1)(a) or paragraph
458 (1)(b) commits a misdemeanor of the first degree, punishable as
459 provided in s. 775.082 or s. 775.083, Florida Statutes. A person
460 who violates paragraph (1)(c) commits a felony of the third
461 degree, punishable as provided in s. 775.082, s. 775.083, or s.
462 775.084, Florida Statutes. In any warrant, information, or
463 indictment, it is not necessary to negate any exceptions, and
464 the burden of any exception is upon the defendant.
465 Section 5. Paragraph (a) of subsection (1) of section
466 458.3191, Florida Statutes, is amended to read:
467 458.3191 Physician survey.—
468 (1) Each person who applies for licensure renewal as a
469 physician under this chapter or chapter 459 must, in conjunction
470 with the renewal of such license under procedures adopted by the
471 Department of Health and in addition to any other information
472 that may be required from the applicant, furnish the following
473 to the Department of Health in a physician survey:
474 (a) Licensee information, including, but not limited to:
475 1. Frequency and geographic location of practice within the
476 state.
477 2. Practice setting.
478 3. Percentage of time spent in direct patient care.
479 4. Anticipated change to license or practice status.
480 5. Areas of specialty or certification.
481 6. Whether the department has ever approved or denied the
482 physician’s registration for access to a patient’s information
483 in the prescription drug monitoring program’s database.
484 7. Whether the physician uses the prescription drug
485 monitoring program with patients in his or her medical practice.
486 Section 6. Subsection (3) is added to section 458.3192,
487 Florida Statutes, to read:
488 458.3192 Analysis of survey results; report.—
489 (3) By November 1 each year, the Department of Health shall
490 provide nonidentifying information to the prescription drug
491 monitoring program’s Implementation and Oversight Task Force
492 regarding the number of physicians who are registered with the
493 prescription drug monitoring program and who also use the
494 database from the prescription drug monitoring program for their
495 patients in their medical practice.
496 Section 7. Paragraph (a) of subsection (1) and paragraphs
497 (a) and (c) of subsection (2) of section 458.3265, Florida
498 Statutes, are amended, and paragraphs (f) and (g) are added to
499 subsection (5) of that section, to read:
500 458.3265 Pain-management clinics.—
501 (1) REGISTRATION.—
502 (a) All privately owned pain-management clinics,
503 facilities, or offices, hereinafter referred to as “clinics,”
504 which advertise in any medium for any type of pain-management
505 services, or employ a physician who is primarily engaged in the
506 treatment of pain by prescribing or dispensing controlled
507 substance medications, must register with the department unless:
508 1. That clinic is licensed as a facility pursuant to
509 chapter 395;
510 2. The majority of the physicians who provide services in
511 the clinic primarily provide surgical services or interventional
512 pain procedures of the type routinely billed using surgical
513 codes;
514 3. The clinic is owned by a publicly held corporation whose
515 shares are traded on a national exchange or on the over-the
516 counter market and whose total assets at the end of the
517 corporation’s most recent fiscal quarter exceeded $50 million;
518 4. The clinic is affiliated with an accredited medical
519 school at which training is provided for medical students,
520 residents, or fellows;
521 5. The clinic does not prescribe or dispense controlled
522 substances for the treatment of pain; or
523 6. The clinic is owned by a corporate entity exempt from
524 federal taxation under 26 U.S.C. s. 501(c)(3).
525 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
526 apply to any physician who provides professional services in a
527 pain-management clinic that is required to be registered in
528 subsection (1).
529 (a) A physician may not practice medicine in a pain
530 management clinic, as described in subsection (4), if:
531 1. the pain-management clinic is not registered with the
532 department as required by this section.; or
533 2. Effective July 1, 2012, the physician has not
534 successfully completed a pain-medicine fellowship that is
535 accredited by the Accreditation Council for Graduate Medical
536 Education or a pain-medicine residency that is accredited by the
537 Accreditation Council for Graduate Medical Education or, prior
538 to July 1, 2012, does not comply with rules adopted by the
539 board.
540
541 Any physician who qualifies to practice medicine in a pain
542 management clinic pursuant to rules adopted by the Board of
543 Medicine as of July 1, 2012, may continue to practice medicine
544 in a pain-management clinic as long as the physician continues
545 to meet the qualifications set forth in the board rules. A
546 physician who violates this paragraph is subject to disciplinary
547 action by his or her appropriate medical regulatory board.
548 (c) A physician, an advanced registered nurse practitioner,
549 or a physician assistant must perform an appropriate medical a
550 physical examination of a patient on the same day that the
551 physician he or she dispenses or prescribes a controlled
552 substance to a patient at a pain-management clinic. If the
553 physician prescribes or dispenses more than a 72-hour dose of
554 controlled substances for the treatment of chronic nonmalignant
555 pain, the physician must document in the patient’s record the
556 reason such dosage is within the standard of care. For the
557 purpose of this paragraph, the standard of care is set forth in
558 rule 64B8-9.013(3), Florida Administrative Code for prescribing
559 or dispensing that quantity.
560 (5) PENALTIES; ENFORCEMENT.—
561 (f) A licensee or other person who serves as the designated
562 physician of a pain-management clinic as defined in this section
563 or s. 459.0137 and registers a pain-management clinic through
564 misrepresentation or fraud or procures or attempts to procure
565 the registration of a pain-management clinic for any other
566 person by making or causing to be made any false or fraudulent
567 representation commits a felony of the third degree, punishable
568 as provided in s. 775.082, s. 775.083, or s. 775.084.
569 (g) Any person who registers a pain-management clinic
570 through misrepresentation or fraud or who procures or attempts
571 to procure the registration of a pain-management clinic for any
572 other person by making or causing to be made any false or
573 fraudulent representation, commits a felony of the third degree,
574 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
575 Section 8. Paragraphs (f) and (g) are added to subsection
576 (1), paragraphs (g) and (h) are added to subsection (2), and
577 subsection (3) is added to section 458.327, Florida Statutes, to
578 read:
579 458.327 Penalty for violations.—
580 (1) Each of the following acts constitutes a felony of the
581 third degree, punishable as provided in s. 775.082, s. 775.083,
582 or s. 775.084:
583 (f) Failing to perform a physical examination of a patient
584 by a physician or a licensed designee acting under the
585 physician’s supervision on the same day that the treating
586 physician dispenses or prescribes a controlled substance to the
587 patient at a pain-management clinic occurring three or more
588 times within a 6-month period, or failing to perform a physical
589 examination on three or more different patients on the same day
590 that the treating physician dispenses or prescribes a controlled
591 substance to each patient at a pain-management clinic within a
592 6-month period.
593 (g) Prescribing or dispensing in excess of a 72-hour dose
594 of controlled substances at a pain-management clinic for the
595 treatment of chronic nonmalignant pain of a patient occurring
596 three or more times within a 6-month period without documenting
597 in the patient’s record the reason that such dosage is within
598 the standard of care. For the purpose of this paragraph, the
599 standard of care is set forth in rule 64B8-9.013(3), Florida
600 Administrative Code.
601 (2) Each of the following acts constitutes a misdemeanor of
602 the first degree, punishable as provided in s. 775.082 or s.
603 775.083:
604 (g) Failing to perform a physical examination of a patient
605 on the same day that the treating physician dispenses or
606 prescribes a controlled substance to the patient at a pain
607 management clinic two times in a 6-month period, or failing to
608 perform a physical examination on two different patients on the
609 same day that the treating physician dispenses or prescribes a
610 controlled substance to each patient at a pain-management clinic
611 within a 6-month period.
612 (h) Prescribing or dispensing in excess of a 72-hour dose
613 of controlled substances at a pain-management clinic for the
614 treatment of chronic nonmalignant pain of a patient occurring
615 two times within a 6-month period without documenting in the
616 patient’s record the reason that such dosage is within the
617 standard of care. For the purpose of this paragraph, the
618 standard of care is set forth in rule 64B8-9.013(3), Florida
619 Administrative Code.
620 (3) Each of the following acts constitutes a misdemeanor of
621 the second degree, punishable as provided in s. 775.082 or s.
622 775.083:
623 (a) A first offense of failing to perform a physical
624 examination of a patient on the same day that the treating
625 physician dispenses or prescribes a controlled substance to the
626 patient at a pain-management clinic.
627 (b) A first offense of failing to document in a patient’s
628 record the reason that such dosage is within the standard of
629 care for prescribing or dispensing in excess of a 72-hour dose
630 of controlled substances at a pain-management clinic for the
631 treatment of chronic nonmalignant pain.
632 Section 9. Subsection (11) is added to section 458.331,
633 Florida Statutes, to read:
634 458.331 Grounds for disciplinary action; action by the
635 board and department.—
636 (11) Notwithstanding subsection (2), upon finding that a
637 physician has prescribed or dispensed, or caused to be
638 prescribed or dispensed, a controlled substance in a pain
639 management clinic in a manner that violates the standard of
640 practice as set forth in this chapter or rules adopted pursuant
641 to this chapter, the board shall, at a minimum, suspend the
642 physician’s license for at least 6 months and impose a fine of
643 at least $10,000 per count. Repeated violations shall result in
644 increased penalties.
645 Section 10. Present subsections (3), (4), and (5) of
646 section 459.003, Florida Statutes, are redesignated as
647 subsections (4), (5), and (6), respectively, and a new
648 subsection (3) is added to that section, to read:
649 459.003 Definitions.—As used in this chapter:
650 (3) “Dispensing physician” means an osteopathic physician
651 who is registered as a dispensing practitioner under s.
652 465.0276.
653 Section 11. Paragraphs (f) and (g) are added to subsection
654 (1), paragraphs (e) and (f) are added to subsection (2), and
655 paragraphs (d) and (e) are added to subsection (3) of section
656 459.013, Florida Statutes, to read:
657 459.013 Penalty for violations.—
658 (1) Each of the following acts constitutes a felony of the
659 third degree, punishable as provided in s. 775.082, s. 775.083,
660 or s. 775.084:
661 (f) Failing to perform a physical examination of a patient
662 on the same day that the osteopathic physician dispenses or
663 prescribes a controlled substance to the patient at a pain
664 management clinic occurring three or more times within a 6-month
665 period, or failing to perform a physical examination on three or
666 more different patients on the same day that the osteopathic
667 physician dispenses or prescribes a controlled substance to each
668 patient at a pain-management clinic within a 6-month period.
669 (g) Prescribing or dispensing in excess of a 72-hour dose
670 of controlled substances at a pain-management clinic for the
671 treatment of chronic nonmalignant pain of a patient occurring
672 three or more times within a 6-month period without documenting
673 in the patient’s record the reason that such dosage is within
674 the standard of care. For the purpose of this paragraph, the
675 standard of care is set forth in rule 64B8-9.013(3), Florida
676 Administrative Code.
677 (2) Each of the following acts constitutes a misdemeanor of
678 the first degree, punishable as provided in s. 775.082 or s.
679 775.083:
680 (e) Failing to perform a physical examination of a patient
681 on the same day that the osteopathic physician dispenses or
682 prescribes a controlled substance to the patient at a pain
683 management clinic occurring two times within a 6-month period,
684 or failing to perform a physical examination on two different
685 patients on the same day that the osteopathic physician
686 dispenses or prescribes a controlled substance to each patient
687 at a pain-management clinic within a 6-month period.
688 (f) Prescribing or dispensing in excess of a 72-hour dose
689 of controlled substances at a pain-management clinic for the
690 treatment of chronic nonmalignant pain of a patient occurring
691 two times within a 6-month period without documenting in the
692 patient’s record the reason that such dosage is within the
693 standard of care. For the purpose of this paragraph, the
694 standard of care is set forth in rule 64B8-9.013(3), Florida
695 Administrative Code.
696 (3) Each of the following constitutes a misdemeanor of the
697 second degree, punishable as provided in s. 775.082 or s.
698 775.083:
699 (d) A first offense of failing to perform a physical
700 examination of a patient on the same day that the osteopathic
701 physician dispenses or prescribes a controlled substance to the
702 patient at a pain-management clinic.
703 (e) A first offense of failing to document in a patient’s
704 record the reason that such dosage is within the standard of
705 care for prescribing or dispensing in excess of a 72-hour dose
706 of controlled substances at a pain-management clinic for the
707 treatment of chronic nonmalignant pain. For the purpose of this
708 paragraph, the standard of care is set forth in rule 64B8
709 9.013(3), Florida Administrative Code.
710 Section 12. Paragraph (a) of subsection (1) and paragraph
711 (c) of subsection (2) of section 459.0137, Florida Statutes, are
712 amended, and paragraphs (f) and (g) are added to subsection (5)
713 of that section, to read:
714 459.0137 Pain-management clinics.—
715 (1) REGISTRATION.—
716 (a) All privately owned pain-management clinics,
717 facilities, or offices, hereinafter referred to as “clinics,”
718 which advertise in any medium for any type of pain-management
719 services, or employ an osteopathic physician who is primarily
720 engaged in the treatment of pain by prescribing or dispensing
721 controlled substance medications, must register with the
722 department unless:
723 1. That clinic is licensed as a facility pursuant to
724 chapter 395;
725 2. The majority of the physicians who provide services in
726 the clinic primarily provide surgical services or interventional
727 pain procedures of the type routinely billed using surgical
728 codes;
729 3. The clinic is owned by a publicly held corporation whose
730 shares are traded on a national exchange or on the over-the
731 counter market and whose total assets at the end of the
732 corporation’s most recent fiscal quarter exceeded $50 million;
733 4. The clinic is affiliated with an accredited medical
734 school at which training is provided for medical students,
735 residents, or fellows;
736 5. The clinic does not prescribe or dispense controlled
737 substances for the treatment of pain; or
738 6. The clinic is owned by a corporate entity exempt from
739 federal taxation under 26 U.S.C. s. 501(c)(3).
740 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
741 apply to any osteopathic physician who provides professional
742 services in a pain-management clinic that is required to be
743 registered in subsection (1).
744 (c) An osteopathic physician, an advanced registered nurse
745 practitioner, or a physician assistant must perform an
746 appropriate medical a physical examination of a patient on the
747 same day that the physician he or she dispenses or prescribes a
748 controlled substance to a patient at a pain-management clinic.
749 If the osteopathic physician prescribes or dispenses more than a
750 72-hour dose of controlled substances for the treatment of
751 chronic nonmalignant pain, the osteopathic physician must
752 document in the patient’s record the reason for which
753 prescribing or dispensing a dosage in excess of a 72-hour dose
754 of controlled substances for the treatment of chronic
755 nonmalignant pain is within the standard of care for prescribing
756 or dispensing that quantity.
757 (5) PENALTIES; ENFORCEMENT.—
758 (f) A licensee or other person who serves as the designated
759 physician of a pain-management clinic as defined in s. 458.3265
760 or s. 459.0137 and registers a pain-management clinic through
761 intentional misrepresentation or fraud or procures or attempts
762 to procure the registration of a pain-management clinic for any
763 other person by making or causing to be made any false or
764 fraudulent representation commits a felony of the third degree,
765 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
766 (g) Any person who registers a pain-management clinic
767 through misrepresentation or fraud or who procures or attempts
768 to procure the registration of a pain-management clinic for any
769 other person by making or causing to be made any false or
770 fraudulent representation, commits a felony of the third degree,
771 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
772 Section 13. Subsection (11) is added to section 459.015,
773 Florida Statutes, to read:
774 459.015 Grounds for disciplinary action; action by the
775 board and department.—
776 (11) Notwithstanding subsection (2), upon finding that an
777 osteopathic physician has prescribed or dispensed, or caused to
778 be prescribed or dispensed, a controlled substance in a pain
779 management clinic in a manner that violates the standard of
780 practice as set forth in this chapter or rules adopted pursuant
781 to this chapter, the board shall, at a minimum, suspend the
782 osteopathic physician’s license for at least 6 months and impose
783 a fine of at least $10,000 per count. Repeated violations shall
784 result in increased penalties.
785 Section 14. Present subsections (3) and (4) of section
786 465.015, Florida Statutes, are renumbered as subsections (4) and
787 (5), respectively, and a new subsection (3) is added to that
788 section, to read:
789 465.015 Violations and penalties.—
790 (3)(a) A licensed pharmacist or other person employed by or
791 at a pharmacy may not knowingly fail to timely report to the
792 local county sheriff’s office the name of any person who obtains
793 or attempts to obtain a substance controlled by s. 893.03 which
794 the licensed pharmacist or other person employed by or at the
795 pharmacy knows or reasonably should have known was obtained or
796 attempted to be obtained from the pharmacy through any
797 fraudulent method or representation. A licensed pharmacist or
798 other person employed by or at a pharmacy who fails to make such
799 a report within 24 hours after learning of the fraud or
800 attempted fraud commits a misdemeanor of the first degree,
801 punishable as provided in s. 775.082 or s. 775.083.
802 (b) A sufficient report of the fraudulent obtaining of or
803 attempt to obtain a controlled substance under this subsection
804 must contain, at a minimum, a copy of the prescription used or
805 presented and a narrative, including all information available
806 to the pharmacy regarding:
807 1. The transaction, such as the name and telephone number
808 of the prescribing physician;
809 2. The name, description, and any personal identification
810 information pertaining to the person presenting the
811 prescription; and
812 3. All other material information, such as photographic or
813 video surveillance of the transaction.
814
815 A licensed pharmacist or other person employed by or at a
816 pharmacy is not subject to disciplinary action for reporting
817 under this subsection.
818 Section 15. Subsection (6) is added to section 465.0276,
819 Florida Statutes, to read:
820 465.0276 Dispensing practitioner.—
821 (6) In order to dispense a controlled substance listed in
822 Schedule II, Schedule III, or Schedule IV in s. 893.03, a
823 practitioner authorized by law to prescribe a controlled
824 substance shall register with the Board of Pharmacy as a
825 dispensing practitioner who dispenses controlled substances and
826 pay a fee not to exceed $100. The department shall adopt rules
827 establishing procedures for renewal of the registration every 4
828 years.
829 Section 16. Paragraph (a) of subsection (1) of section
830 766.101, Florida Statutes, is amended to read:
831 766.101 Medical review committee, immunity from liability.—
832 (1) As used in this section:
833 (a) The term “medical review committee” or “committee”
834 means:
835 1.a. A committee of a hospital or ambulatory surgical
836 center licensed under chapter 395 or a health maintenance
837 organization certificated under part I of chapter 641,
838 b. A committee of a physician-hospital organization, a
839 provider-sponsored organization, or an integrated delivery
840 system,
841 c. A committee of a state or local professional society of
842 health care providers,
843 d. A committee of a medical staff of a licensed hospital or
844 nursing home, provided the medical staff operates pursuant to
845 written bylaws that have been approved by the governing board of
846 the hospital or nursing home,
847 e. A committee of the Department of Corrections or the
848 Correctional Medical Authority as created under s. 945.602, or
849 employees, agents, or consultants of either the department or
850 the authority or both,
851 f. A committee of a professional service corporation formed
852 under chapter 621 or a corporation organized under chapter 607
853 or chapter 617, which is formed and operated for the practice of
854 medicine as defined in s. 458.305(4) s. 458.305(3), and which
855 has at least 25 health care providers who routinely provide
856 health care services directly to patients,
857 g. A committee of the Department of Children and Family
858 Services which includes employees, agents, or consultants to the
859 department as deemed necessary to provide peer review,
860 utilization review, and mortality review of treatment services
861 provided pursuant to chapters 394, 397, and 916,
862 h. A committee of a mental health treatment facility
863 licensed under chapter 394 or a community mental health center
864 as defined in s. 394.907, provided the quality assurance program
865 operates pursuant to the guidelines which have been approved by
866 the governing board of the agency,
867 i. A committee of a substance abuse treatment and education
868 prevention program licensed under chapter 397 provided the
869 quality assurance program operates pursuant to the guidelines
870 which have been approved by the governing board of the agency,
871 j. A peer review or utilization review committee organized
872 under chapter 440,
873 k. A committee of the Department of Health, a county health
874 department, healthy start coalition, or certified rural health
875 network, when reviewing quality of care, or employees of these
876 entities when reviewing mortality records, or
877 l. A continuous quality improvement committee of a pharmacy
878 licensed pursuant to chapter 465,
879
880 which committee is formed to evaluate and improve the quality of
881 health care rendered by providers of health service, to
882 determine that health services rendered were professionally
883 indicated or were performed in compliance with the applicable
884 standard of care, or that the cost of health care rendered was
885 considered reasonable by the providers of professional health
886 services in the area; or
887 2. A committee of an insurer, self-insurer, or joint
888 underwriting association of medical malpractice insurance, or
889 other persons conducting review under s. 766.106.
890 Section 17. Subsection (3) of section 810.02, Florida
891 Statutes, is amended to read:
892 810.02 Burglary.—
893 (3) Burglary is a felony of the second degree, punishable
894 as provided in s. 775.082, s. 775.083, or s. 775.084, if, in the
895 course of committing the offense, the offender does not make an
896 assault or battery and is not and does not become armed with a
897 dangerous weapon or explosive, and the offender enters or
898 remains in a:
899 (a) Dwelling, and there is another person in the dwelling
900 at the time the offender enters or remains;
901 (b) Dwelling, and there is not another person in the
902 dwelling at the time the offender enters or remains;
903 (c) Structure, and there is another person in the structure
904 at the time the offender enters or remains;
905 (d) Conveyance, and there is another person in the
906 conveyance at the time the offender enters or remains; or
907 (e) Authorized emergency vehicle, as defined in s. 316.003;
908 or.
909 (f) Structure or conveyance when the offense intended to be
910 committed is theft of a substance controlled by s. 893.03.
911 Notwithstanding any contrary provisions of law, separate
912 judgments and sentences for burglary with the intent to commit
913 theft of a controlled substance under this paragraph and for any
914 applicable offense for possession of a controlled substance
915 under s. 893.13, or an offense for trafficking in a controlled
916 substance under s. 893.135, may be imposed if all such offenses
917 involve the same amount or amounts of a controlled substance.
918
919 However, if the burglary is committed within a county that is
920 subject to a state of emergency declared by the Governor under
921 chapter 252 after the declaration of emergency is made and the
922 perpetration of the burglary is facilitated by conditions
923 arising from the emergency, the burglary is a felony of the
924 first degree, punishable as provided in s. 775.082, s. 775.083,
925 or s. 775.084. As used in this subsection, the term “conditions
926 arising from the emergency” means civil unrest, power outages,
927 curfews, voluntary or mandatory evacuations, or a reduction in
928 the presence of or response time for first responders or
929 homeland security personnel. A person arrested for committing a
930 burglary within a county that is subject to such a state of
931 emergency may not be released until the person appears before a
932 committing magistrate at a first appearance hearing. For
933 purposes of sentencing under chapter 921, a felony offense that
934 is reclassified under this subsection is ranked one level above
935 the ranking under s. 921.0022 or s. 921.0023 of the offense
936 committed.
937 Section 18. Paragraph (c) of subsection (2) of section
938 812.014, Florida Statutes, is amended to read:
939 812.014 Theft.—
940 (2)
941 (c) It is grand theft of the third degree and a felony of
942 the third degree, punishable as provided in s. 775.082, s.
943 775.083, or s. 775.084, if the property stolen is:
944 1. Valued at $300 or more, but less than $5,000.
945 2. Valued at $5,000 or more, but less than $10,000.
946 3. Valued at $10,000 or more, but less than $20,000.
947 4. A will, codicil, or other testamentary instrument.
948 5. A firearm.
949 6. A motor vehicle, except as provided in paragraph (a).
950 7. Any commercially farmed animal, including any animal of
951 the equine, bovine, or swine class, or other grazing animal, and
952 including aquaculture species raised at a certified aquaculture
953 facility. If the property stolen is aquaculture species raised
954 at a certified aquaculture facility, then a $10,000 fine shall
955 be imposed.
956 8. Any fire extinguisher.
957 9. Any amount of citrus fruit consisting of 2,000 or more
958 individual pieces of fruit.
959 10. Taken from a designated construction site identified by
960 the posting of a sign as provided for in s. 810.09(2)(d).
961 11. Any stop sign.
962 12. Anhydrous ammonia.
963 13. Any amount of a substance controlled by s. 893.03.
964 Notwithstanding any contrary provisions of law, separate
965 judgments and sentences for theft of a controlled substance
966 under this subparagraph, and for any applicable offense for
967 possession of a controlled substance under s. 893.13, or an
968 offense for trafficking in a controlled substance under s.
969 893.135 may be imposed if all such offenses involve the same
970 amount or amounts of controlled substance.
971
972 However, if the property is stolen within a county that is
973 subject to a state of emergency declared by the Governor under
974 chapter 252, the property is stolen after the declaration of
975 emergency is made, and the perpetration of the theft is
976 facilitated by conditions arising from the emergency, the
977 offender commits a felony of the second degree, punishable as
978 provided in s. 775.082, s. 775.083, or s. 775.084, if the
979 property is valued at $5,000 or more, but less than $10,000, as
980 provided under subparagraph 2., or if the property is valued at
981 $10,000 or more, but less than $20,000, as provided under
982 subparagraph 3. As used in this paragraph, the term “conditions
983 arising from the emergency” means civil unrest, power outages,
984 curfews, voluntary or mandatory evacuations, or a reduction in
985 the presence of or the response time for first responders or
986 homeland security personnel. For purposes of sentencing under
987 chapter 921, a felony offense that is reclassified under this
988 paragraph is ranked one level above the ranking under s.
989 921.0022 or s. 921.0023 of the offense committed.
990 Section 19. Section 893.021, Florida Statutes, is created
991 to read:
992 893.021 Adulterated drug.—
993 (1) As used in this chapter, a drug is adulterated if it is
994 a controlled substance that:
995 (a) Has been produced, prepared, packed, and marketed for
996 oral consumption by the manufacturer; and
997 (b) Has had any change to its integrity or composition for
998 use by means of inhalation, injection, or any other form of
999 ingestion not in accordance with the manufacturer’s recommended
1000 use, and such mode of use has not been previously directed and
1001 approved by the prescribing physician.
1002 (2) A physician is not prevented from directing or
1003 prescribing a change to the recognized manufactured
1004 recommendations for use in a patient who presents a medical need
1005 for such a requirement change of any controlled substance. The
1006 prescribing physician shall clearly indicate any deviation of
1007 the recognized manufacturer’s recommended use of a controlled
1008 substance on the original prescription, and the licensed
1009 pharmacist shall clearly indicate such deviation on the label of
1010 the prescription upon dispensing the controlled substance.
1011 Section 20. Paragraphs (c), (d), and (e) of subsection (1)
1012 of section 893.04, Florida Statutes, are amended to read:
1013 893.04 Pharmacist and practitioner.—
1014 (1) A pharmacist, in good faith and in the course of
1015 professional practice only, may dispense controlled substances
1016 upon a written or oral prescription of a practitioner, under the
1017 following conditions:
1018 (c) The following information must There shall appear on
1019 the face of the prescription or written record of a thereof for
1020 the controlled substance the following information:
1021 1. The full name and address of the person for whom, or the
1022 owner of the animal for which, the controlled substance is
1023 dispensed.
1024 2. The full name and address of the prescribing
1025 practitioner and the practitioner’s federal controlled substance
1026 registry number shall be printed thereon.
1027 3. If the prescription is for an animal, the species of
1028 animal for which the controlled substance is prescribed.
1029 4. The name of the controlled substance prescribed and the
1030 strength, quantity, and directions for use thereof. The
1031 directions for use must specify the authorization by the
1032 physician, any instructions requiring the adulteration of the
1033 dispensed form of the medication, and the medical necessity for
1034 the adulteration in accordance with s. 893.021.
1035 5. The number of the prescription, as recorded in the
1036 prescription files of the pharmacy in which it is filled.
1037 6. The initials of the pharmacist filling the prescription
1038 and the date filled.
1039 (d) The prescription must shall be retained on file by the
1040 proprietor of the pharmacy in which it is filled for a period of
1041 2 years.
1042 (e) A label bearing the following information must be
1043 affixed to the original container in which a controlled
1044 substance is delivered as upon a prescription or authorized
1045 refill thereof, as hereinafter provided, there shall be a label
1046 bearing the following information:
1047 1. The name and address of the pharmacy from which such
1048 controlled substance was dispensed.
1049 2. The date on which the prescription for such controlled
1050 substance was filled.
1051 3. The number of such prescription, as recorded in the
1052 prescription files of the pharmacy in which it is filled.
1053 4. The name of the prescribing practitioner.
1054 5. The name of the patient for whom, or of the owner and
1055 species of the animal for which, the controlled substance is
1056 prescribed.
1057 6. The directions for the use of the controlled substance
1058 prescribed in the prescription.
1059 7. A clear, concise warning that it is a crime to transfer
1060 the controlled substance to any person other than the patient
1061 for whom prescribed.
1062 Section 21. Section 893.055, Florida Statutes, is amended
1063 to read:
1064 893.055 Prescription drug monitoring program.—
1065 (1) As used in this section, the term:
1066 (a) “Patient advisory report” or “advisory report” means
1067 information provided by the department in writing, or as
1068 determined by the department, to a prescriber, dispenser,
1069 pharmacy, or patient concerning the dispensing of controlled
1070 substances. All advisory reports are for informational purposes
1071 only and impose no obligations of any nature or any legal duty
1072 on a prescriber, dispenser, pharmacy, or patient. The patient
1073 advisory report shall be provided in accordance with s.
1074 893.13(7)(a)8. The advisory reports issued by the department are
1075 not subject to discovery or introduction into evidence in any
1076 civil or administrative action against a prescriber, dispenser,
1077 pharmacy, or patient arising out of matters that are the subject
1078 of the report; and a person who participates in preparing,
1079 reviewing, issuing, or any other activity related to an advisory
1080 report may not be permitted or required to testify in any such
1081 civil action as to any findings, recommendations, evaluations,
1082 opinions, or other actions taken in connection with preparing,
1083 reviewing, or issuing such a report.
1084 (b) “Controlled substance” means a controlled substance
1085 listed in Schedule II, Schedule III, or Schedule IV in s.
1086 893.03.
1087 (c) “Dispenser” means a pharmacy, dispensing pharmacist, or
1088 dispensing health care practitioner.
1089 (d) “Health care practitioner” or “practitioner” means any
1090 practitioner who is subject to licensure or regulation by the
1091 department under chapter 458, chapter 459, chapter 461, chapter
1092 462, chapter 464, chapter 465, or chapter 466.
1093 (e) “Health care regulatory board” means any board for a
1094 practitioner or health care practitioner who is licensed or
1095 regulated by the department.
1096 (f) “Pharmacy” means any pharmacy that is subject to
1097 licensure or regulation by the department under chapter 465 and
1098 that dispenses or delivers a controlled substance to an
1099 individual or address in this state.
1100 (g) “Prescriber” means a prescribing physician, prescribing
1101 practitioner, or other prescribing health care practitioner.
1102 (h) “Active investigation” means an investigation that is
1103 being conducted with a reasonable, good faith belief that it
1104 could lead to the filing of administrative, civil, or criminal
1105 proceedings, or that is ongoing and continuing and for which
1106 there is a reasonable, good faith anticipation of securing an
1107 arrest or prosecution in the foreseeable future.
1108 (i) “Law enforcement agency” means the Department of Law
1109 Enforcement, a Florida sheriff’s department, a Florida police
1110 department, or a law enforcement agency of the Federal
1111 Government which enforces the laws of this state or the United
1112 States relating to controlled substances, and which its agents
1113 and officers are empowered by law to conduct criminal
1114 investigations and make arrests.
1115 (j) “Program manager” means an employee of or a person
1116 contracted by the Department of Health who is designated to
1117 ensure the integrity of the prescription drug monitoring program
1118 in accordance with the requirements established in paragraphs
1119 (2)(a) and (b).
1120 (2)(a) By December 1, 2010, the department shall design and
1121 establish a comprehensive electronic database system that has
1122 controlled substance prescriptions provided to it and that
1123 provides prescription information to a patient’s health care
1124 practitioner and pharmacist who inform the department that they
1125 wish the patient advisory report provided to them. Otherwise,
1126 the patient advisory report will not be sent to the
1127 practitioner, pharmacy, or pharmacist. The system shall be
1128 designed to provide information regarding dispensed
1129 prescriptions of controlled substances and shall not infringe
1130 upon the legitimate prescribing or dispensing of a controlled
1131 substance by a prescriber or dispenser acting in good faith and
1132 in the course of professional practice. The system shall be
1133 consistent with standards of the American Society for Automation
1134 in Pharmacy (ASAP). The electronic system shall also comply with
1135 the Health Insurance Portability and Accountability Act (HIPAA)
1136 as it pertains to protected health information (PHI), electronic
1137 protected health information (EPHI), the National All Schedules
1138 Prescription Electronic Reporting (NASPER) Act’s minimum
1139 requirements for authentication of a practitioner who requests
1140 information in the prescription drug monitoring program database
1141 and certification of the purpose for which information is
1142 requested, and all other relevant state and federal privacy and
1143 security laws and regulations. The department shall establish
1144 policies and procedures as appropriate regarding the reporting,
1145 accessing the database, evaluation, management, development,
1146 implementation, operation, storage, and security of information
1147 within the system. The reporting of prescribed controlled
1148 substances shall include a dispensing transaction with a
1149 dispenser pursuant to chapter 465 or through a dispensing
1150 transaction to an individual or address in this state with a
1151 pharmacy that is not located in this state but that is otherwise
1152 subject to the jurisdiction of this state as to that dispensing
1153 transaction. The reporting of patient advisory reports refers
1154 only to reports to patients, pharmacies, and practitioners.
1155 Separate reports that contain patient prescription history
1156 information and that are not patient advisory reports are
1157 provided to persons and entities as authorized in paragraphs
1158 (7)(b) and (c) and s. 893.0551.
1159 (b) The department, when the direct support organization
1160 receives at least $20,000 in nonstate moneys or the state
1161 receives at least $20,000 in federal grants for the prescription
1162 drug monitoring program, and in consultation with the Office of
1163 Drug Control, shall adopt rules as necessary concerning the
1164 reporting, accessing the database, evaluation, management,
1165 development, implementation, operation, security, and storage of
1166 information within the system, including rules for when patient
1167 advisory reports are provided to pharmacies and prescribers. The
1168 patient advisory report shall be provided in accordance with s.
1169 893.13(7)(a)8. The department shall work with the professional
1170 health care licensure boards, such as the Board of Medicine, the
1171 Board of Osteopathic Medicine, and the Board of Pharmacy; other
1172 appropriate organizations, such as the Florida Pharmacy
1173 Association, the Office of Drug Control, the Florida Medical
1174 Association, the Florida Retail Federation, and the Florida
1175 Osteopathic Medical Association, including those relating to
1176 pain management; and the Attorney General, the Department of Law
1177 Enforcement, and the Agency for Health Care Administration to
1178 develop rules appropriate for the prescription drug monitoring
1179 program.
1180 (c) All dispensers and prescribers subject to these
1181 reporting requirements shall be notified by the department of
1182 the implementation date for such reporting requirements.
1183 (d) The program manager shall work with professional health
1184 care licensure boards and the stakeholders listed in paragraph
1185 (b) to develop rules appropriate for identifying indicators of
1186 controlled substance abuse.
1187 (e) The department shall establish a method to allow
1188 corrections to the database when notified by a health care
1189 practitioner or pharmacist.
1190 (3) The pharmacy dispensing the controlled substance and
1191 each prescriber who directly dispenses a controlled substance
1192 shall submit to the electronic system, by a procedure and in a
1193 format established by the department and consistent with an
1194 ASAP-approved format, the following information for inclusion in
1195 the database:
1196 (a) The name of the prescribing practitioner, the
1197 practitioner’s federal Drug Enforcement Administration
1198 registration number, the practitioner’s National Provider
1199 Identification (NPI) or other appropriate identifier, and the
1200 date of the prescription.
1201 (b) The date the prescription was filled and the method of
1202 payment, such as cash by an individual, insurance coverage
1203 through a third party, or Medicaid payment. This paragraph does
1204 not authorize the department to include individual credit card
1205 numbers or other account numbers in the database.
1206 (c) The full name, address, and date of birth of the person
1207 for whom the prescription was written.
1208 (d) The name, national drug code, quantity, and strength of
1209 the controlled substance dispensed.
1210 (e) The full name, federal Drug Enforcement Administration
1211 registration number, and address of the pharmacy or other
1212 location from which the controlled substance was dispensed. If
1213 the controlled substance was dispensed by a practitioner other
1214 than a pharmacist, the practitioner’s full name, federal Drug
1215 Enforcement Administration registration number, and address.
1216 (f) The name of the pharmacy or practitioner, other than a
1217 pharmacist, dispensing the controlled substance and the
1218 practitioner’s National Provider Identification (NPI).
1219 (g) Other appropriate identifying information as determined
1220 by department rule.
1221 (h) The number of refills ordered and whether the drug was
1222 dispensed as a refill of a prescription or was a first-time
1223 request.
1224 (4) Each time a controlled substance is dispensed to an
1225 individual, the controlled substance shall be reported to the
1226 department through the system as soon thereafter as possible,
1227 but not more than 7 15 days after the date the controlled
1228 substance is dispensed unless an extension is approved by the
1229 department for cause as determined by rule. A dispenser must
1230 meet the reporting requirements of this section by providing the
1231 required information concerning each controlled substance that
1232 it dispensed in a department-approved, secure methodology and
1233 format. Such approved formats may include, but are not limited
1234 to, submission via the Internet, on a disc, or by use of regular
1235 mail.
1236 (5) When the following acts of dispensing or administering
1237 occur, the following are exempt from reporting under this
1238 section for that specific act of dispensing or administration:
1239 (a) A health care practitioner when administering a
1240 controlled substance directly to a patient if the amount of the
1241 controlled substance is adequate to treat the patient during
1242 that particular treatment session.
1243 (b) A pharmacist or health care practitioner when
1244 administering a controlled substance to a patient or resident
1245 receiving care as a patient at a hospital, nursing home,
1246 ambulatory surgical center, hospice, or intermediate care
1247 facility for the developmentally disabled which is licensed in
1248 this state.
1249 (c) A practitioner when administering or dispensing a
1250 controlled substance in the health care system of the Department
1251 of Corrections.
1252 (c)(d) A practitioner when administering a controlled
1253 substance in the emergency room of a licensed hospital.
1254 (d)(e) A health care practitioner when administering or
1255 dispensing a controlled substance to a person under the age of
1256 16 if the amount of the controlled substance is adequate to
1257 treat the patient during that particular treatment session.
1258 (e)(f) A pharmacist or a dispensing practitioner when
1259 dispensing a one-time, 48-hour 72-hour emergency resupply of a
1260 controlled substance to a patient.
1261 (6) The department may establish when to suspend and when
1262 to resume reporting information during a state-declared or
1263 nationally declared disaster.
1264 (7)(a) A practitioner or pharmacist who dispenses a
1265 controlled substance must submit the information required by
1266 this section in an electronic or other method in an ASAP format
1267 approved by rule of the department unless otherwise provided in
1268 this section. The cost to the dispenser in submitting the
1269 information required by this section may not be material or
1270 extraordinary. Costs not considered to be material or
1271 extraordinary include, but are not limited to, regular postage,
1272 electronic media, regular electronic mail, and facsimile
1273 charges.
1274 (b)1. In order for a pharmacy, prescriber, practitioner, or
1275 dispenser to shall have access to information in the
1276 prescription drug monitoring program’s database which relates to
1277 a patient of that pharmacy, prescriber, practitioner, or
1278 dispenser, the pharmacy, prescriber, practitioner, or dispenser
1279 shall register with the department by submitting a registering
1280 document provided by the department. The document and validation
1281 of that document shall be determined by the department. Before a
1282 pharmacy, prescriber, practitioner, or dispenser is granted
1283 access to information in the database from the prescription drug
1284 monitoring program, the department shall approve the submitted
1285 document. Upon approval, the department shall grant the
1286 registrant access to the appropriate information in the
1287 prescription drug monitoring program’s database in a manner
1288 established by the department as needed for the purpose of
1289 reviewing the patient’s controlled substance prescription
1290 history.
1291 2. Other access to the program’s database shall be limited
1292 to the program’s manager and to the designated program and
1293 support staff, who may act only at the direction of the program
1294 manager or, in the absence of the program manager, as
1295 authorized. Access by the program manager or such designated
1296 staff is for prescription drug program management only or for
1297 management of the program’s database and its system in support
1298 of the requirements of this section and in furtherance of the
1299 prescription drug monitoring program. Confidential and exempt
1300 information in the database shall be released only as provided
1301 in paragraph (c) and s. 893.0551. The program manager,
1302 designated program and support staff who act at the direction of
1303 or in the absence of the program manager, and any individual who
1304 has similar access regarding the management of the database from
1305 the prescription drug monitoring program shall submit
1306 fingerprints to the department for background screening. The
1307 department shall follow the procedure established by the
1308 Department of Law Enforcement to request a statewide criminal
1309 history record check and to request that the Department of Law
1310 Enforcement forward the fingerprints to the Federal Bureau of
1311 Investigation for a national criminal history record check.
1312 (c) The following entities may shall not have be allowed
1313 direct access to information in the prescription drug monitoring
1314 program database but may request from the program manager and,
1315 when authorized by the program manager, the program manager’s
1316 program and support staff, information that is confidential and
1317 exempt under s. 893.0551. Prior to release, the request shall be
1318 verified as authentic and authorized with the requesting
1319 organization by the program manager, the program manager’s
1320 program and support staff, or as determined in rules by the
1321 department as being authentic and as having been authorized by
1322 the requesting entity:
1323 1. The department or its relevant health care regulatory
1324 boards responsible for the licensure, regulation, or discipline
1325 of practitioners, pharmacists, or other persons who are
1326 authorized to prescribe, administer, or dispense controlled
1327 substances and who are involved in a specific controlled
1328 substance investigation involving a designated person for one or
1329 more prescribed controlled substances.
1330 2. The Attorney General for Medicaid fraud cases or
1331 Medicaid investigations involving prescribed controlled
1332 substances.
1333 3. A law enforcement agency during active investigations
1334 regarding potential criminal activity, fraud, or theft regarding
1335 prescribed controlled substances.
1336 4. A patient or the legal guardian or designated health
1337 care surrogate of an incapacitated patient as described in s.
1338 893.0551 who, for the purpose of verifying the accuracy of the
1339 database information, submits a written and notarized request
1340 that includes the patient’s full name, address, and date of
1341 birth, and includes the same information if the legal guardian
1342 or health care surrogate submits the request. The patient’s
1343 phone number, current address, and a copy of a government-issued
1344 photo identification must be provided in person to the program
1345 manager along with the notarized request. The request shall be
1346 validated by the department to verify the identity of the
1347 patient and the legal guardian or health care surrogate, if the
1348 patient’s legal guardian or health care surrogate is the
1349 requestor. Such verification is also required for any request to
1350 change a patient’s prescription history or other information
1351 related to his or her information in the electronic database.
1352 5. The Agency for Health Care Administration for Medicaid
1353 fraud cases or Medicaid investigations involving prescribed
1354 controlled substances.
1355
1356 Information in the database for the electronic prescription drug
1357 monitoring system is not discoverable or admissible in any civil
1358 or administrative action, except in an investigation and
1359 disciplinary proceeding by the department or the appropriate
1360 regulatory board.
1361 (d) The following entities may shall not have be allowed
1362 direct access to information in the prescription drug monitoring
1363 program database but may request from the program manager and,
1364 when authorized by the program manager, the program manager’s
1365 program and support staff, information that contains no
1366 identifying information of any patient, physician, health care
1367 practitioner, prescriber, or dispenser and that is not
1368 confidential and exempt:
1369 1. Department staff for the purpose of calculating
1370 performance measures pursuant to subsection (8).
1371 2. The Program Implementation and Oversight Task Force for
1372 its reporting to the Governor, the President of the Senate, and
1373 the Speaker of the House of Representatives regarding the
1374 prescription drug monitoring program. This subparagraph expires
1375 July 1, 2012.
1376 (e) All transmissions of data required by this section must
1377 comply with relevant state and federal privacy and security laws
1378 and regulations. However, any authorized agency or person under
1379 s. 893.0551 receiving such information as allowed by s. 893.0551
1380 may maintain the information received for up to 24 months before
1381 purging it from his or her records or maintain it for longer
1382 than 24 months if the information is pertinent to ongoing health
1383 care or an active law enforcement investigation or prosecution.
1384 (f) The program manager, upon determining a pattern
1385 consistent with the rules established under paragraph (2)(d) and
1386 having cause to believe a violation of s. 893.13(7)(a)8.,
1387 (8)(a), or (8)(b) has occurred, may provide relevant information
1388 to the applicable law enforcement agency.
1389 (8) To assist in fulfilling program responsibilities,
1390 performance measures shall be reported annually to the Governor,
1391 the President of the Senate, and the Speaker of the House of
1392 Representatives by the department each December 1, beginning in
1393 2011. Data that does not contain patient, physician, health care
1394 practitioner, prescriber, or dispenser identifying information
1395 may be requested during the year by department employees so that
1396 the department may undertake public health care and safety
1397 initiatives that take advantage of observed trends. Performance
1398 measures may include, but are not limited to, efforts to achieve
1399 the following outcomes:
1400 (a) Reduction of the rate of inappropriate use of
1401 prescription drugs through department education and safety
1402 efforts.
1403 (b) Reduction of the quantity of pharmaceutical controlled
1404 substances obtained by individuals attempting to engage in fraud
1405 and deceit.
1406 (c) Increased coordination among partners participating in
1407 the prescription drug monitoring program.
1408 (d) Involvement of stakeholders in achieving improved
1409 patient health care and safety and reduction of prescription
1410 drug abuse and prescription drug diversion.
1411 (9) Any person who willfully and knowingly fails to report
1412 the dispensing of a controlled substance as required by this
1413 section commits a misdemeanor of the first degree, punishable as
1414 provided in s. 775.082 or s. 775.083.
1415 (10) All costs incurred by the department in administering
1416 the prescription drug monitoring program shall be funded through
1417 federal grants or private funding applied for or received by the
1418 state. The department may not commit funds for the monitoring
1419 program without ensuring funding is available. The prescription
1420 drug monitoring program and the implementation thereof are
1421 contingent upon receipt of the nonstate funding. The department
1422 and state government shall cooperate with the direct-support
1423 organization established pursuant to subsection (11) in seeking
1424 federal grant funds, other nonstate grant funds, gifts,
1425 donations, or other private moneys for the department so long as
1426 the costs of doing so are not considered material. Nonmaterial
1427 costs for this purpose include, but are not limited to, the
1428 costs of mailing and personnel assigned to research or apply for
1429 a grant. Notwithstanding the exemptions to competitive
1430 solicitation requirements under s. 287.057(3)(f), the department
1431 shall comply with the competitive-solicitation requirements
1432 under s. 287.057 for the procurement of any goods or services
1433 required by this section.
1434 (11) The Office of Drug Control, in coordination with the
1435 department, may establish a direct-support organization that has
1436 a board consisting of at least five members to provide
1437 assistance, funding, and promotional support for the activities
1438 authorized for the prescription drug monitoring program.
1439 (a) As used in this subsection, the term “direct-support
1440 organization” means an organization that is:
1441 1. A Florida corporation not for profit incorporated under
1442 chapter 617, exempted from filing fees, and approved by the
1443 Department of State.
1444 2. Organized and operated to conduct programs and
1445 activities; raise funds; request and receive grants, gifts, and
1446 bequests of money; acquire, receive, hold, and invest, in its
1447 own name, securities, funds, objects of value, or other
1448 property, either real or personal; and make expenditures or
1449 provide funding to or for the direct or indirect benefit of the
1450 department in the furtherance of the prescription drug
1451 monitoring program.
1452 (b) The direct-support organization is not considered a
1453 lobbying firm within the meaning of s. 11.045.
1454 (c) The director of the Office of Drug Control shall
1455 appoint a board of directors for the direct-support
1456 organization. The director may designate employees of the Office
1457 of Drug Control, state employees other than state employees from
1458 the department, and any other nonstate employees as appropriate,
1459 to serve on the board. Members of the board shall serve at the
1460 pleasure of the director of the Office of Drug Control. The
1461 director shall provide guidance to members of the board to
1462 ensure that moneys received by the direct-support organization
1463 are not received from inappropriate sources. Inappropriate
1464 sources include, but are not limited to, donors, grantors,
1465 persons, or organizations that may monetarily or substantively
1466 benefit from the purchase of goods or services by the department
1467 in furtherance of the prescription drug monitoring program.
1468 (d) The direct-support organization shall operate under
1469 written contract with the Office of Drug Control. The contract
1470 must, at a minimum, provide for:
1471 1. Approval of the articles of incorporation and bylaws of
1472 the direct-support organization by the Office of Drug Control.
1473 2. Submission of an annual budget for the approval of the
1474 Office of Drug Control.
1475 3. Certification by the Office of Drug Control in
1476 consultation with the department that the direct-support
1477 organization is complying with the terms of the contract in a
1478 manner consistent with and in furtherance of the goals and
1479 purposes of the prescription drug monitoring program and in the
1480 best interests of the state. Such certification must be made
1481 annually and reported in the official minutes of a meeting of
1482 the direct-support organization.
1483 4. The reversion, without penalty, to the Office of Drug
1484 Control, or to the state if the Office of Drug Control ceases to
1485 exist, of all moneys and property held in trust by the direct
1486 support organization for the benefit of the prescription drug
1487 monitoring program if the direct-support organization ceases to
1488 exist or if the contract is terminated.
1489 5. The fiscal year of the direct-support organization,
1490 which must begin July 1 of each year and end June 30 of the
1491 following year.
1492 6. The disclosure of the material provisions of the
1493 contract to donors of gifts, contributions, or bequests,
1494 including such disclosure on all promotional and fundraising
1495 publications, and an explanation to such donors of the
1496 distinction between the Office of Drug Control and the direct
1497 support organization.
1498 7. The direct-support organization’s collecting, expending,
1499 and providing of funds to the department for the development,
1500 implementation, and operation of the prescription drug
1501 monitoring program as described in this section and s. 2,
1502 chapter 2009-198, Laws of Florida, as long as the task force is
1503 authorized. The direct-support organization may collect and
1504 expend funds to be used for the functions of the direct-support
1505 organization’s board of directors, as necessary and approved by
1506 the director of the Office of Drug Control. In addition, the
1507 direct-support organization may collect and provide funding to
1508 the department in furtherance of the prescription drug
1509 monitoring program by:
1510 a. Establishing and administering the prescription drug
1511 monitoring program’s electronic database, including hardware and
1512 software.
1513 b. Conducting studies on the efficiency and effectiveness
1514 of the program to include feasibility studies as described in
1515 subsection (13).
1516 c. Providing funds for future enhancements of the program
1517 within the intent of this section.
1518 d. Providing user training of the prescription drug
1519 monitoring program, including distribution of materials to
1520 promote public awareness and education and conducting workshops
1521 or other meetings, for health care practitioners, pharmacists,
1522 and others as appropriate.
1523 e. Providing funds for travel expenses.
1524 f. Providing funds for administrative costs, including
1525 personnel, audits, facilities, and equipment.
1526 g. Fulfilling all other requirements necessary to implement
1527 and operate the program as outlined in this section.
1528 (e) The activities of the direct-support organization must
1529 be consistent with the goals and mission of the Office of Drug
1530 Control, as determined by the office in consultation with the
1531 department, and in the best interests of the state. The direct
1532 support organization must obtain a written approval from the
1533 director of the Office of Drug Control for any activities in
1534 support of the prescription drug monitoring program before
1535 undertaking those activities.
1536 (f) The Office of Drug Control, in consultation with the
1537 department, may permit, without charge, appropriate use of
1538 administrative services, property, and facilities of the Office
1539 of Drug Control and the department by the direct-support
1540 organization, subject to this section. The use must be directly
1541 in keeping with the approved purposes of the direct-support
1542 organization and may not be made at times or places that would
1543 unreasonably interfere with opportunities for the public to use
1544 such facilities for established purposes. Any moneys received
1545 from rentals of facilities and properties managed by the Office
1546 of Drug Control and the department may be held by the Office of
1547 Drug Control or in a separate depository account in the name of
1548 the direct-support organization and subject to the provisions of
1549 the letter of agreement with the Office of Drug Control. The
1550 letter of agreement must provide that any funds held in the
1551 separate depository account in the name of the direct-support
1552 organization must revert to the Office of Drug Control if the
1553 direct-support organization is no longer approved by the Office
1554 of Drug Control to operate in the best interests of the state.
1555 (g) The Office of Drug Control, in consultation with the
1556 department, may adopt rules under s. 120.54 to govern the use of
1557 administrative services, property, or facilities of the
1558 department or office by the direct-support organization.
1559 (h) The Office of Drug Control may not permit the use of
1560 any administrative services, property, or facilities of the
1561 state by a direct-support organization if that organization does
1562 not provide equal membership and employment opportunities to all
1563 persons regardless of race, color, religion, gender, age, or
1564 national origin.
1565 (i) The direct-support organization shall provide for an
1566 independent annual financial audit in accordance with s.
1567 215.981. Copies of the audit shall be provided to the Office of
1568 Drug Control and the Office of Policy and Budget in the
1569 Executive Office of the Governor.
1570 (j) The direct-support organization may not exercise any
1571 power under s. 617.0302(12) or (16).
1572 (12) A prescriber or dispenser may have access to the
1573 information under this section which relates to a patient of
1574 that prescriber or dispenser as needed for the purpose of
1575 reviewing the patient’s controlled drug prescription history. A
1576 prescriber or dispenser acting in good faith is immune from any
1577 civil, criminal, or administrative liability that might
1578 otherwise be incurred or imposed for receiving or using
1579 information from the prescription drug monitoring program. This
1580 subsection does not create a private cause of action, and a
1581 person may not recover damages against a prescriber or dispenser
1582 authorized to access information under this subsection for
1583 accessing or failing to access such information.
1584 (13) To the extent that funding is provided for such
1585 purpose through federal or private grants or gifts and other
1586 types of available moneys, the department, in collaboration with
1587 the Office of Drug Control, shall study the feasibility of
1588 enhancing the prescription drug monitoring program for the
1589 purposes of public health initiatives and statistical reporting
1590 that respects the privacy of the patient, the prescriber, and
1591 the dispenser. Such a study shall be conducted in order to
1592 further improve the quality of health care services and safety
1593 by improving the prescribing and dispensing practices for
1594 prescription drugs, taking advantage of advances in technology,
1595 reducing duplicative prescriptions and the overprescribing of
1596 prescription drugs, and reducing drug abuse. The requirements of
1597 the National All Schedules Prescription Electronic Reporting
1598 (NASPER) Act are authorized in order to apply for federal NASPER
1599 funding. In addition, the direct-support organization shall
1600 provide funding for the department, in collaboration with the
1601 Office of Drug Control, to conduct training for health care
1602 practitioners and other appropriate persons in using the
1603 monitoring program to support the program enhancements.
1604 (14) A pharmacist, pharmacy, or dispensing health care
1605 practitioner or his or her agent, before releasing a controlled
1606 substance to any person not known to such dispenser, shall
1607 require the person purchasing, receiving, or otherwise acquiring
1608 the controlled substance to present valid photographic
1609 identification or other verification of his or her identity to
1610 the dispenser. If the person does not have proper
1611 identification, the dispenser may verify the validity of the
1612 prescription and the identity of the patient with the prescriber
1613 or his or her authorized agent. Verification of health plan
1614 eligibility through a real-time inquiry or adjudication system
1615 will be considered to be proper identification. This subsection
1616 does not apply in an institutional setting or to a long-term
1617 care facility, including, but not limited to, an assisted living
1618 facility or a hospital to which patients are admitted. As used
1619 in this subsection, the term “proper identification” means an
1620 identification that is issued by a state or the Federal
1621 Government containing the person’s photograph, printed name, and
1622 signature or a document considered acceptable under 8 C.F.R. s.
1623 274a.2(b)(1)(v)(A) and (B).
1624 (15) The Agency for Health Care Administration shall
1625 continue the promotion of electronic prescribing by health care
1626 practitioners, health care facilities, and pharmacies under s.
1627 408.0611.
1628 (16) By October 1, 2010, the department shall adopt rules
1629 pursuant to ss. 120.536(1) and 120.54 to administer the
1630 provisions of this section, which shall include as necessary the
1631 reporting, accessing, evaluation, management, development,
1632 implementation, operation, and storage of information within the
1633 monitoring program’s system.
1634 (17) After the prescription drug monitoring program’s
1635 database has been operational for 12 months, the State Surgeon
1636 General shall enter into reciprocal agreements for the sharing
1637 of prescription drug monitoring information with any other state
1638 that has a compatible prescription drug monitoring program. If
1639 the State Surgeon General evaluates the prescription drug
1640 monitoring program of another state as authorized in this
1641 subsection, priority shall be given to a state that is
1642 contiguous with the borders of this state.
1643 (a) In determining compatibility, the State Surgeon General
1644 shall consider:
1645 1. The essential purposes of the program and the success of
1646 the program in fulfilling those purposes.
1647 2. The safeguards for privacy of patient records and the
1648 success of the program in protecting patient privacy.
1649 3. The persons authorized to view the data collected by the
1650 program. Comparable organizations and professions for
1651 practitioners in other states, law enforcement agencies, the
1652 Attorney General’s Medicaid Fraud Unit, medical regulatory
1653 boards, and, as needed, management staff who have similar duties
1654 as management staff who work with the prescription drug
1655 monitoring program as authorized in s. 893.0551 are authorized
1656 access upon approval by the State Surgeon General.
1657 4. The schedules of the controlled substances that are
1658 monitored.
1659 5. The data required to be submitted for each prescription.
1660 6. Any implementing criteria deemed essential for a
1661 thorough comparison.
1662 (b) The State Surgeon General shall annually review any
1663 agreement to determine its continued compatibility with the
1664 prescription drug monitoring program in this state.
1665 (c) Any agreement between the State Surgeon General and
1666 another state shall prohibit the sharing of information
1667 concerning a resident of this state or a practitioner,
1668 pharmacist, or other prescriber for any purpose that is not
1669 otherwise authorized by this section or s. 893.0551.
1670 Section 22. Paragraph (a) of subsection (3) of section
1671 893.0551, Florida Statutes, is amended, present subsections (4),
1672 (5), (6), and (7) of that section are redesignated as
1673 subsections (5), (6), (7), and (8), respectively, and a new
1674 subsection (4) is added to that section, to read:
1675 893.0551 Public records exemption for the prescription drug
1676 monitoring program.—
1677 (3) The department shall disclose such confidential and
1678 exempt information to the following entities after using a
1679 verification process to ensure the legitimacy of that person’s
1680 or entity’s request for the information:
1681 (a) The Attorney General and his or her designee when
1682 working on Medicaid fraud cases and Medicaid investigations
1683 involving prescribed controlled substances prescription drugs or
1684 when the Attorney General has initiated a review of specific
1685 identifiers of Medicaid fraud or specific identifiers that
1686 warrant a Medicaid investigation regarding prescribed controlled
1687 substances prescription drugs. The Attorney General or his or
1688 her designee may disclose the confidential and exempt
1689 information received from the department to a criminal justice
1690 agency as defined in s. 119.011 as part of an active
1691 investigation that is specific to a violation of prescription
1692 drug abuse or prescription drug diversion law as it relates to
1693 controlled substances. The Attorney General’s Medicaid fraud
1694 investigators and Medicaid investigators may not have direct
1695 access to the department’s database.
1696 (4) The department may disclose confidential and exempt
1697 information contained in records held by the department under s.
1698 893.055 if the State Surgeon General has entered into a
1699 reciprocal agreement for the sharing of prescription drug
1700 monitoring information with any other state that has a
1701 compatible prescription drug monitoring program.
1702 (a) The reciprocal agreement may allow the following
1703 persons from another state to receive information from the
1704 prescription drug monitoring program if approved by the State
1705 Surgeon General:
1706 1. A designated representative of a state professional
1707 licensing, certification, or regulatory agency charged with
1708 oversight of those persons authorized to prescribe or dispense
1709 controlled substances for the purpose of a bona fide, specific
1710 investigation of a prescription of a controlled substance which
1711 involves a designated person. As required in s. 893.055, this
1712 authorization does not preclude the requirement for the program
1713 manager to review the request for information and validate it.
1714 2. A health care practitioner or pharmacist licensed in the
1715 state from which the request originates. Such health care
1716 practitioner or pharmacist shall certify that the requested
1717 information is for the purpose of providing medical or
1718 pharmaceutical treatment to a bona fide, current patient. The
1719 health care practitioner or pharmacist shall follow all the
1720 procedures required in s. 893.055 and rules established by the
1721 department for a health care practitioner or pharmacist to
1722 request information from the database.
1723 3. A law enforcement officer from another state:
1724 a. Who is a member of a sheriff’s department or a police
1725 department;
1726 b. Who is authorized by law to conduct criminal
1727 investigations and make arrests;
1728 c. Whose duty it is to enforce the laws of his or her state
1729 relating to controlled substances; and
1730 d. Who is engaged in a bona fide specific, active
1731 investigation involving a designated person regarding
1732 prescriptions for controlled substances.
1733
1734 As required in s. 893.055, this authorization does not preclude
1735 the requirement for the program manager to review the request
1736 for information and validate it. This authorization also does
1737 not preclude the ability to provide a report to a law
1738 enforcement agency in another state under s. 893.055(7) or this
1739 subsection.
1740 (b) Any agreement between the State Surgeon General and
1741 another state shall prohibit the sharing of information
1742 concerning a resident of this state, a patient whose information
1743 is in the program’s database, or a practitioner, pharmacy,
1744 pharmacist, health care practitioner, or other prescriber for
1745 any purpose that is not otherwise authorized by this section or
1746 s. 893.055, and the information must be provided according to
1747 the State Surgeon General’s determination of compatibility as
1748 described in s. 893.055(17).
1749 Section 23. Subsections (1), (4), and (5) of section
1750 893.07, Florida Statutes, are amended, and subsection (6) is
1751 added to that section, to read:
1752 893.07 Records.—
1753 (1) Notwithstanding any other provision of law and in
1754 consonance with the authority of State v. Carter, 23 So. 3d 798
1755 (Fla. 1st DCA 2009) and State v. Tamulonis, 39 So. 3d 524 (Fla.
1756 2nd DCA 2010), every person who engages in the manufacture,
1757 compounding, mixing, cultivating, growing, or by any other
1758 process producing or preparing, or in the dispensing,
1759 importation, or, as a wholesaler, distribution, of controlled
1760 substances shall:
1761 (a) On January 1, 1974, or as soon thereafter as any person
1762 first engages in such activity, and every second year
1763 thereafter, make a complete and accurate record of all stocks of
1764 controlled substances on hand. The inventory may be prepared on
1765 the regular physical inventory date which is nearest to, and
1766 does not vary by more than 6 months from, the biennial date that
1767 would otherwise apply. As additional substances are designated
1768 for control under this chapter, they shall be inventoried as
1769 provided for in this subsection.
1770 (b) On and after January 1, 1974, maintain, on a current
1771 basis, a complete and accurate record of each substance
1772 manufactured, received, sold, delivered, or otherwise disposed
1773 of by him or her, except that this subsection shall not require
1774 the maintenance of a perpetual inventory.
1775
1776 Compliance with the provisions of federal law pertaining to the
1777 keeping of records of controlled substances shall be deemed a
1778 compliance with the requirements of this subsection.
1779 (4) Every inventory or record required by this chapter,
1780 including prescription records, shall be maintained:
1781 (a) Separately from all other records of the registrant, or
1782 (b) Alternatively, in the case of Schedule III, IV, or V
1783 controlled substances, in such form that information required by
1784 this chapter is readily retrievable from the ordinary business
1785 records of the registrant.
1786
1787 In either case, such records described in this subsection shall
1788 be kept and made available for a period of at least 2 years for
1789 inspection and copying by law enforcement officers whose duty it
1790 is to enforce the laws of this state relating to controlled
1791 substances. This subsection does not require a law enforcement
1792 officer to obtain a subpoena, court order, or search warrant in
1793 order to obtain access to or copies of such records.
1794 (5) Each person shall maintain a record that contains which
1795 shall contain a detailed list of controlled substances lost,
1796 destroyed, or stolen, if any; the kind and quantity of such
1797 controlled substances; and the date of the discovering of such
1798 loss, destruction, or theft. If a person discovers the theft or
1799 loss of a controlled substance, such person shall report the
1800 theft or loss to a local county sheriff’s office within 48 hours
1801 after the discovery of such theft or loss. A person who fails to
1802 report the theft or loss of a controlled substance under this
1803 subsection commits a misdemeanor of the second degree,
1804 punishable as provided in s. 775.082 or s. 775.083. However, a
1805 person who fails to report the theft or loss of a Schedule II
1806 controlled substance commits a misdemeanor of the first degree,
1807 punishable as provided in s. 775.082 or s. 775.083.
1808 (6) The Legislature finds that the opinions rendered in
1809 State v. Carter, 23 So. 3d 798 (Fla. 1st DCA 2009), and State v.
1810 Tamulonis, 39 So. 3d 524 (Fla. 2nd DCA 2010), correctly construe
1811 this Legislature’s intent that the inspection powers previously
1812 conferred upon law enforcement officers which allow such
1813 officers to access and review pharmacy records concerning
1814 controlled substances are to be exercised properly by such law
1815 enforcement officers without the requirement of a subpoena or
1816 search warrant being sought or issued to examine and copy such
1817 records, and without the requirement that those persons to whom
1818 particular pharmacy records refer be given notice of the
1819 records’ examination and copying under this section.
1820 Section 24. Subsections (7) and (8) of section 893.13,
1821 Florida Statutes, are amended to read:
1822 893.13 Prohibited acts; penalties.—
1823 (7)(a) A It is unlawful for any person may not:
1824 1. To Distribute or dispense a controlled substance in
1825 violation of this chapter.
1826 2. To Refuse or fail to make, keep, or furnish any record,
1827 notification, order form, statement, invoice, or information
1828 required under this chapter.
1829 3. To Refuse an entry into any premises for any inspection
1830 or to refuse to allow any inspection authorized by this chapter.
1831 4. To Distribute a controlled substance named or described
1832 in s. 893.03(1) or (2) except pursuant to an order form as
1833 required by s. 893.06.
1834 5. To Keep or maintain any store, shop, warehouse,
1835 dwelling, building, vehicle, boat, aircraft, or other structure
1836 or place which is resorted to by persons using controlled
1837 substances in violation of this chapter for the purpose of using
1838 these substances, or which is used for keeping or selling them
1839 in violation of this chapter.
1840 6. To Use to his or her own personal advantage, or to
1841 reveal, any information obtained in enforcement of this chapter
1842 except in a prosecution or administrative hearing for a
1843 violation of this chapter.
1844 7. To Possess a prescription form which has not been
1845 completed and signed by the practitioner whose name appears
1846 printed thereon, unless the person is that practitioner, is an
1847 agent or employee of that practitioner, is a pharmacist, or is a
1848 supplier of prescription forms who is authorized by that
1849 practitioner to possess those forms.
1850 8. To Withhold information from a practitioner from whom
1851 the person seeks to obtain a controlled substance or a
1852 prescription for a controlled substance that the person making
1853 the request has received a controlled substance or a
1854 prescription for a controlled substance of like therapeutic use
1855 from another practitioner within the previous 30 days.
1856 9. To Acquire or obtain, or attempt to acquire or obtain,
1857 possession of a controlled substance by misrepresentation,
1858 fraud, forgery, deception, or subterfuge.
1859 10. To Affix any false or forged label to a package or
1860 receptacle containing a controlled substance.
1861 11. To Furnish false or fraudulent material information in,
1862 or omit any material information from, any report or other
1863 document required to be kept or filed under this chapter or any
1864 record required to be kept by this chapter.
1865 12. To Store anhydrous ammonia in a container that is not
1866 approved by the United States Department of Transportation to
1867 hold anhydrous ammonia or is not constructed in accordance with
1868 sound engineering, agricultural, or commercial practices.
1869 13. With the intent to obtain a controlled substance or
1870 combination of controlled substances that are not medically
1871 necessary for the person or an amount of a controlled substance
1872 or substances that are not medically necessary for the person,
1873 obtain or attempt to obtain from a practitioner a controlled
1874 substance or a prescription for a controlled substance by
1875 misrepresentation, fraud, forgery, deception, subterfuge, or
1876 concealment of a material fact. For purposes of this
1877 subparagraph, a material fact includes whether the person has an
1878 existing prescription for a controlled substance issued for the
1879 same period of time by another practitioner or as described in
1880 subparagraph 8.
1881 (b) A health care practitioner, with the intent to provide
1882 a controlled substance or combination of controlled substances
1883 that are not medically necessary to his or her patient or an
1884 amount of controlled substances that are not medically necessary
1885 for his or her patient, may not provide a controlled substance
1886 or a prescription for a controlled substance by
1887 misrepresentation, fraud, forgery, deception, subterfuge, or
1888 concealment of a material fact. For purposes of this paragraph,
1889 a material fact includes whether the patient has an existing
1890 prescription for a controlled substance issued for the same
1891 period of time by another practitioner or as described in
1892 subparagraph (a)8.
1893 (c) Any person who adulterates a controlled substance for
1894 directed off-label use without authorization by a prescribing
1895 physician violates the provisions of subparagraph (a)1. and
1896 causes the issuance of the entire prescription for the
1897 controlled substance to become invalid. A law enforcement
1898 officer in the performance of his or her official duties may
1899 seize the adulterated or off-label prescribed controlled
1900 substance as evidence. The controlled substance may be returned
1901 to the owner only with a notarized affidavit from the original
1902 prescribing practitioner who has knowledge and gave
1903 authorization and explicit directions for the adulteration or
1904 off-label use of the controlled substance.
1905 (d)(b) Any person who violates the provisions of
1906 subparagraphs (a)1.-7. commits a misdemeanor of the first
1907 degree, punishable as provided in s. 775.082 or s. 775.083;
1908 except that, upon a second or subsequent violation, the person
1909 commits a felony of the third degree, punishable as provided in
1910 s. 775.082, s. 775.083, or s. 775.084.
1911 (e)(c) Any person who violates the provisions of
1912 subparagraphs (a)8.-12. commits a felony of the third degree,
1913 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
1914 (f) A person or health care practitioner who violates the
1915 provisions of paragraph (b) or subparagraph (a)13. commits a
1916 felony of the third degree, punishable as provided in s.
1917 775.082, s. 775.083, or s. 775.084, if any controlled substance
1918 that is the subject of the offense is listed in Schedule II,
1919 Schedule III, or Schedule IV.
1920 (8)(a) Notwithstanding subsection (9), a prescribing
1921 practitioner may not:
1922 1. Knowingly assist a patient, other person, or the owner
1923 of an animal in obtaining a controlled substance through
1924 deceptive, untrue, or fraudulent representations in or related
1925 to the practice of the prescribing practitioner’s professional
1926 practice;
1927 2. Employ a trick or scheme in the practice of the
1928 prescribing practitioner’s professional practice to assist a
1929 patient, other person, or the owner of an animal in obtaining a
1930 controlled substance;
1931 3. Knowingly write a prescription for a controlled
1932 substance for a fictitious person; or
1933 4. Write a prescription for a controlled substance for a
1934 patient, other person, or an animal if the sole purpose of
1935 writing such prescription is to provide a monetary benefit to,
1936 or obtain a monetary benefit for, the prescribing practitioner;
1937 or.
1938 5. Write a prescription for a controlled substance for a
1939 patient, other person, or an animal and authorize or direct the
1940 adulteration of the dispensed form of the controlled substance
1941 for the purpose of ingestion by means of inhalation, injection,
1942 or any other means not medically necessary for the treatment of
1943 the patient.
1944 (b) If the prescribing practitioner wrote a prescription or
1945 multiple prescriptions for a controlled substance for the
1946 patient, other person, or animal for which there was no medical
1947 necessity, or which was in excess of what was medically
1948 necessary to treat the patient, other person, or animal, that
1949 fact does not give rise to any presumption that the prescribing
1950 practitioner violated subparagraph (a)1., but may be considered
1951 with other competent evidence in determining whether the
1952 prescribing practitioner knowingly assisted a patient, other
1953 person, or the owner of an animal to obtain a controlled
1954 substance in violation of subparagraph (a)1.
1955 (c) A person who violates paragraph (a) commits a felony of
1956 the third degree, punishable as provided in s. 775.082, s.
1957 775.083, or s. 775.084.
1958 (d) Notwithstanding paragraph (c), if a prescribing
1959 practitioner has violated paragraph (a) and received $1,000 or
1960 more in payment for writing one or more prescriptions or, in the
1961 case of a prescription written for a controlled substance
1962 described in s. 893.135, has written one or more prescriptions
1963 for a quantity of a controlled substance which, individually or
1964 in the aggregate, meets the threshold for the offense of
1965 trafficking in a controlled substance under s. 893.15, the
1966 violation is reclassified as a felony of the second degree and
1967 ranked in level 4 of the Criminal Punishment Code.
1968 Section 25. Present subsections (3) through (10) of section
1969 893.138, Florida Statutes, are redesignated as subsections (4)
1970 through (11), respectively, and a new subsection (3) is added to
1971 that section, to read:
1972 893.138 Local administrative action to abate drug-related,
1973 prostitution-related, or stolen-property-related public
1974 nuisances and criminal gang activity.—
1975 (3) Any pain-management clinic, as described in s. 458.3265
1976 or s. 459.0137, which has been used on more than two occasions
1977 within a 6-month period as the site of a violation of:
1978 (a) Section 784.011, s. 784.021, s. 784.03, or s. 784.045,
1979 relating to assault and battery;
1980 (b) Section 810.02, relating to burglary;
1981 (c) Section 812.014, relating to dealing in theft;
1982 (d) Section 812.131, relating to robbery by sudden
1983 snatching; or
1984 (e) Section 893.13, relating to the unlawful distribution
1985 of controlled substances,
1986
1987 may be declared to be a public nuisance, and such nuisance may
1988 be abated pursuant to the procedures provided in this section.
1989 Section 26. (1) DEFINITIONS.—As used in this section, the
1990 term:
1991 (a) “Interchange or substitution of an opioid analgesic
1992 drug” means the substitution of any opioid analgesic drug, brand
1993 or generic, for the opioid analgesic drug incorporating a
1994 tamper-resistance technology originally prescribed, irrespective
1995 of whether the substituted drug is rated as pharmaceutically and
1996 therapeutically equivalent by the United States Food and Drug
1997 Administration or the Board of Pharmacy or whether the opioid
1998 analgesic drug with tamper-resistance technology bears a
1999 labeling claim with respect to reduction of tampering, abuse, or
2000 abuse potential.
2001 (b) “Opioid analgesic drug” means a drug in the opioid
2002 analgesic drug class prescribed to treat moderate to severe pain
2003 or other conditions, whether in immediate release or extended
2004 release form and whether or not combined with other drug
2005 substances to form a single tablet or other dosage form.
2006 (c) “Opioid analgesic drug incorporating a tamper
2007 resistance technology” means an opioid analgesic drug listed as
2008 such by the Board of Pharmacy based on a submission of evidence
2009 by the drug manufacturer or distributor that the drug:
2010 1. Incorporates a tamper-resistance technology; and
2011 2. Has been approved by the United States Food and Drug
2012 Administration pursuant to an application that includes at least
2013 one study on human tampering or abuse potential or a laboratory
2014 study comparing the tamper- or abuse-resistance properties of
2015 the drug to one or more opioid analgesic drugs that:
2016 a. Have been approved by the United States Food and Drug
2017 Administration; and
2018 b. Serve as a positive control.
2019 (d) “Pharmacist” means any person licensed under chapter
2020 465, Florida Statutes, to practice the profession of pharmacy,
2021 including, but not limited to, a community pharmacist and a
2022 pharmacist in a hospital-based pharmacy, when filling
2023 prescriptions for inpatient or outpatient care.
2024 (2) LIST OF OPIOID ANALGESIC DRUGS INCORPORATING A TAMPER
2025 RESISTANCE TECHNOLOGY.—The Board of Pharmacy shall create a list
2026 of opioid analgesic drugs for which information has been
2027 submitted consistent with paragraph (1)(c). Inclusion of a drug
2028 on such list does not require that the drug bear a labeling
2029 claim with respect to reduction of tampering, abuse, or abuse
2030 potential at the time of listing. Such list must also include a
2031 determination by the Board of Pharmacy as to which listed opioid
2032 analgesic drugs incorporating tamper-resistance technologies
2033 provide substantially similar tamper-resistance properties,
2034 based solely on studies submitted by the drug manufacturer
2035 consistent with paragraph (1)(c).
2036 Section 27. This act shall take effect October 1, 2011.