Florida Senate - 2011 COMMITTEE AMENDMENT
Bill No. SB 818
Barcode 958050
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
03/14/2011 .
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The Committee on Health Regulation (Fasano) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Subsections (4) and (7) of section 400.9905,
6 Florida Statutes, are amended to read:
7 400.9905 Definitions.—
8 (4) “Clinic” means an entity at which health care services
9 are provided to individuals and which tenders charges for
10 reimbursement or payment for such services, including a mobile
11 clinic and a portable equipment provider. For purposes of this
12 part, the term does not include and the licensure requirements
13 of this part do not apply to:
14 (a) Entities licensed or registered by the state under
15 chapter 395; or entities licensed or registered by the state and
16 providing only health care services within the scope of services
17 authorized under their respective licenses granted under ss.
18 383.30-383.335, chapter 390, chapter 394, chapter 397, this
19 chapter except part X, chapter 429, chapter 463, chapter 465,
20 chapter 466, chapter 478, part I of chapter 483, chapter 484, or
21 chapter 651; end-stage renal disease providers authorized under
22 42 C.F.R. part 405, subpart U; or providers certified under 42
23 C.F.R. part 485, subpart B or subpart H; or any entity that
24 provides neonatal or pediatric hospital-based health care
25 services or other health care services by licensed practitioners
26 solely within a hospital licensed under chapter 395.
27 (b) Entities that own, directly or indirectly, entities
28 licensed or registered by the state pursuant to chapter 395; or
29 entities that own, directly or indirectly, entities licensed or
30 registered by the state and providing only health care services
31 within the scope of services authorized pursuant to their
32 respective licenses granted under ss. 383.30-383.335, chapter
33 390, chapter 394, chapter 397, this chapter except part X,
34 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
35 part I of chapter 483, chapter 484, chapter 651; end-stage renal
36 disease providers authorized under 42 C.F.R. part 405, subpart
37 U; or providers certified under 42 C.F.R. part 485, subpart B or
38 subpart H; or any entity that provides neonatal or pediatric
39 hospital-based health care services by licensed practitioners
40 solely within a hospital licensed under chapter 395.
41 (c) Entities that are owned, directly or indirectly, by an
42 entity licensed or registered by the state pursuant to chapter
43 395; or entities that are owned, directly or indirectly, by an
44 entity licensed or registered by the state and providing only
45 health care services within the scope of services authorized
46 pursuant to their respective licenses granted under ss. 383.30
47 383.335, chapter 390, chapter 394, chapter 397, this chapter
48 except part X, chapter 429, chapter 463, chapter 465, chapter
49 466, chapter 478, part I of chapter 483, chapter 484, or chapter
50 651; end-stage renal disease providers authorized under 42
51 C.F.R. part 405, subpart U; or providers certified under 42
52 C.F.R. part 485, subpart B or subpart H; or any entity that
53 provides neonatal or pediatric hospital-based health care
54 services by licensed practitioners solely within a hospital
55 under chapter 395.
56 (d) Entities that are under common ownership, directly or
57 indirectly, with an entity licensed or registered by the state
58 pursuant to chapter 395; or entities that are under common
59 ownership, directly or indirectly, with an entity licensed or
60 registered by the state and providing only health care services
61 within the scope of services authorized pursuant to their
62 respective licenses granted under ss. 383.30-383.335, chapter
63 390, chapter 394, chapter 397, this chapter except part X,
64 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
65 part I of chapter 483, chapter 484, or chapter 651; end-stage
66 renal disease providers authorized under 42 C.F.R. part 405,
67 subpart U; or providers certified under 42 C.F.R. part 485,
68 subpart B or subpart H; or any entity that provides neonatal or
69 pediatric hospital-based health care services by licensed
70 practitioners solely within a hospital licensed under chapter
71 395.
72 (e) An entity that is exempt from federal taxation under 26
73 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan
74 under 26 U.S.C. s. 409 that has a board of trustees not less
75 than two-thirds of which are Florida-licensed health care
76 practitioners and provides only physical therapy services under
77 physician orders, any community college or university clinic,
78 and any entity owned or operated by the federal or state
79 government, including agencies, subdivisions, or municipalities
80 thereof.
81 (f) A sole proprietorship, group practice, partnership, or
82 corporation that provides health care services by physicians
83 covered by s. 627.419, that is directly supervised by one or
84 more of such physicians, and that is wholly owned by one or more
85 of those physicians or by a physician and the spouse, parent,
86 child, or sibling of that physician.
87 (g) A sole proprietorship, group practice, partnership, or
88 corporation that provides health care services by licensed
89 health care practitioners under chapter 457, chapter 458,
90 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
91 chapter 466, chapter 467, chapter 480, chapter 484, chapter 486,
92 chapter 490, chapter 491, or part I, part III, part X, part
93 XIII, or part XIV of chapter 468, or s. 464.012, which are
94 wholly owned by one or more licensed health care practitioners,
95 or the licensed health care practitioners set forth in this
96 paragraph and the spouse, parent, child, or sibling of a
97 licensed health care practitioner, so long as one of the owners
98 who is a licensed health care practitioner is supervising the
99 business activities and is legally responsible for the entity’s
100 compliance with all federal and state laws. However, a health
101 care practitioner may not supervise services beyond the scope of
102 the practitioner’s license, except that, for the purposes of
103 this part, a clinic owned by a licensee in s. 456.053(3)(b) that
104 provides only services authorized pursuant to s. 456.053(3)(b)
105 may be supervised by a licensee specified in s. 456.053(3)(b).
106 (h) Clinical facilities affiliated with an accredited
107 medical school at which training is provided for medical
108 students, residents, or fellows.
109 (i) Entities that provide only oncology or radiation
110 therapy services by physicians licensed under chapter 458 or
111 chapter 459 or entities that provide oncology or radiation
112 therapy services by physicians licensed under chapter 458 or
113 chapter 459 which are owned by a corporation whose shares are
114 publicly traded on a recognized stock exchange.
115 (j) Clinical facilities affiliated with a college of
116 chiropractic accredited by the Council on Chiropractic Education
117 at which training is provided for chiropractic students.
118 (k) Entities that provide licensed practitioners to staff
119 emergency departments or to deliver anesthesia services in
120 facilities licensed under chapter 395 and that derive at least
121 90 percent of their gross annual revenues from the provision of
122 such services. Entities claiming an exemption from licensure
123 under this paragraph must provide documentation demonstrating
124 compliance.
125 (l) Orthotic or prosthetic clinical facilities that are a
126 publicly traded corporation or that are wholly owned, directly
127 or indirectly, by a publicly traded corporation. As used in this
128 paragraph, a publicly traded corporation is a corporation that
129 issues securities traded on an exchange registered with the
130 United States Securities and Exchange Commission as a national
131 securities exchange.
132 (7) “Portable equipment provider” means an entity that
133 contracts with or employs persons to provide portable equipment
134 to multiple locations performing treatment or diagnostic testing
135 of individuals, that bills third-party payors for those
136 services, and that otherwise meets the definition of a clinic in
137 subsection (4).
138 Section 2. Subsection (7) of section 456.013, Florida
139 Statutes, is amended to read:
140 456.013 Department; general licensing provisions.—
141 (7)(a) The boards, or the department when there is no
142 board, shall require the completion of a 2-hour course relating
143 to prevention of medical errors as part of the licensure and
144 renewal process. The 2-hour course counts shall count towards
145 the total number of continuing education hours required for the
146 profession. The board or department shall approve the course
147 shall be approved by the board or department, as appropriate,
148 which must and shall include a study of root-cause analysis,
149 error reduction and prevention, and patient safety. In addition,
150 the course approved by the Board of Medicine and the Board of
151 Osteopathic Medicine must shall include information relating to
152 the five most misdiagnosed conditions during the previous
153 biennium, as determined by the board. If the course is being
154 offered by a facility licensed under pursuant to chapter 395 for
155 its employees, the board may approve up to 1 hour of the 2-hour
156 course to be specifically related to error reduction and
157 prevention methods used in that facility.
158 (b) As a condition of initial licensure and at each
159 subsequent license renewal, the boards, or the department if
160 there is no board, shall allow each practitioner licensed under
161 chapter 458, chapter 459, chapter 461, chapter 465, or chapter
162 466 whose lawful scope of practice authorizes the practitioner
163 to prescribe, administer, or dispense controlled substances to
164 complete a 1-hour continuing education course relating to the
165 prescription drug monitoring program. The course must include,
166 but need not be limited to:
167 1. The purpose of the prescription drug monitoring program.
168 2. The practitioners’ capabilities for improving the
169 standard of care for patients by using the prescription drug
170 monitoring program.
171 3. How the prescription drug monitoring program can help
172 practitioners detect doctor shopping.
173 4. The involvement of law enforcement personnel, the
174 Attorney General’s Medicaid Fraud Unit, and medical regulatory
175 investigators with the prescription drug monitoring program.
176 5. The procedures for registering for access to the
177 prescription drug monitoring program.
178
179 The course hours may be included in the total number of hours of
180 continuing education required by the profession and must be
181 approved by the board or by the department if there is no board.
182 The boards, or the department if there is no board, shall
183 approve the course offered through a facility licensed under
184 chapter 395 for its employees if the course is at least 3 hours
185 and covers the education requirements.
186 (c) The course requirements in paragraph (b) apply to each
187 licensee renewing his or her license on or after July 1, 2012,
188 and to each applicant approved for licensure on or after January
189 1, 2013.
190 (d) By October 1, 2011, the boards, or the department if
191 there is no board, shall adopt rules as necessary to administer
192 this subsection.
193 Section 3. Section 458.305, Florida Statutes, is amended to
194 read:
195 458.305 Definitions.—As used in this chapter:
196 (1) “Board” means the Board of Medicine.
197 (2) “Department” means the Department of Health.
198 (3) “Dispensing physician” means a physician who is
199 registered as a dispensing practitioner under s. 465.0276.
200 (4)(3) “Practice of medicine” means the diagnosis,
201 treatment, operation, or prescription for any human disease,
202 pain, injury, deformity, or other physical or mental condition.
203 (5)(4) “Physician” means a person who is licensed to
204 practice medicine in this state.
205 Section 4. Advertising of controlled substances by a
206 dispensing physician.—
207 (1)(a) Only a dispensing physician licensed under chapter
208 458 or chapter 459, Florida Statutes, may use the title
209 “dispensing physician” or “dispenser” or otherwise lead the
210 public to believe that he or she is engaged in the dispensing of
211 controlled substances.
212 (b) A person, other than an owner of a:
213 1. Pain-management clinic registered under chapter 458 or
214 chapter 459, Florida Statutes; or
215 2. Health clinic licensed under chapter 400, Florida
216 Statutes,
217
218 may not display any sign or take any other action that would
219 lead the public to believe that such person is engaged in the
220 business of dispensing a controlled substance. Any advertisement
221 that states “dispensing onsite” or “onsite pharmacy” violates
222 this paragraph. This paragraph does not preclude a person who is
223 not licensed as a medical practitioner from owning a pain
224 management clinic.
225 (c) A person, firm, or corporation, unless licensed under
226 chapter 465, Florida Statutes, may not use in a trade name,
227 sign, letter, or advertisement any term, including “drug,”
228 “pharmacy,” “onsite pharmacy,” “dispensing,” “dispensing
229 onsite,” “prescription drugs,” “Rx,” or “apothecary,” which
230 implies that the person, firm, or corporation is licensed or
231 registered to dispense prescription drugs in this state.
232 (2) A person who violates paragraph (1)(a) or paragraph
233 (1)(b) commits a misdemeanor of the first degree, punishable as
234 provided in s. 775.082 or s. 775.083, Florida Statutes. A person
235 who violates paragraph (1)(c) commits a felony of the third
236 degree, punishable as provided in s. 775.082, s. 775.083, or s.
237 775.084, Florida Statutes. In any warrant, information, or
238 indictment, it is not necessary to negate any exceptions, and
239 the burden of any exception is upon the defendant.
240 Section 5. Paragraph (a) of subsection (1) of section
241 458.3191, Florida Statutes, is amended to read:
242 458.3191 Physician survey.—
243 (1) Each person who applies for licensure renewal as a
244 physician under this chapter or chapter 459 must, in conjunction
245 with the renewal of such license under procedures adopted by the
246 Department of Health and in addition to any other information
247 that may be required from the applicant, furnish the following
248 to the Department of Health in a physician survey:
249 (a) Licensee information, including, but not limited to:
250 1. Frequency and geographic location of practice within the
251 state.
252 2. Practice setting.
253 3. Percentage of time spent in direct patient care.
254 4. Anticipated change to license or practice status.
255 5. Areas of specialty or certification.
256 6. Whether the department has ever approved or denied the
257 physician’s registration for access to a patient’s information
258 in the prescription drug monitoring program’s database.
259 7. Whether the physician uses the prescription drug
260 monitoring program with patients in his or her medical practice.
261 Section 6. Subsection (3) is added to section 458.3192,
262 Florida Statutes, to read:
263 458.3192 Analysis of survey results; report.—
264 (3) By November 1 each year, the Department of Health shall
265 provide nonidentifying information to the prescription drug
266 monitoring program’s Implementation and Oversight Task Force
267 regarding the number of physicians who are registered with the
268 prescription drug monitoring program and who also use the
269 database from the prescription drug monitoring program for their
270 patients in their medical practice.
271 Section 7. Paragraphs (a) of subsection (1), and paragraphs
272 (a) and (c) of subsection (2) of section 458.3265, Florida
273 Statutes, are amended, and paragraphs (f) and (g) are added to
274 subsection (5) of that section, to read:
275 458.3265 Pain-management clinics.—
276 (1) REGISTRATION.—
277 (a) All privately owned pain-management clinics,
278 facilities, or offices, hereinafter referred to as “clinics,”
279 which advertise in any medium for any type of pain-management
280 services, or employ a physician who is primarily engaged in the
281 treatment of pain by prescribing or dispensing controlled
282 substance medications, must register with the department unless:
283 1. That clinic is licensed as a facility pursuant to
284 chapter 395;
285 2. The majority of the physicians who provide services in
286 the clinic primarily provide surgical services;
287 3. The clinic is owned by a publicly held corporation whose
288 shares are traded on a national exchange or on the over-the
289 counter market and whose total assets at the end of the
290 corporation’s most recent fiscal quarter exceeded $50 million;
291 4. The clinic is affiliated with an accredited medical
292 school at which training is provided for medical students,
293 residents, or fellows;
294 5. The clinic does not prescribe or dispense controlled
295 substances for the treatment of pain; or
296 6. The clinic is owned by a corporate entity exempt from
297 federal taxation under 26 U.S.C. s. 501(c)(3); or.
298 7. The majority of the physicians who provide services in
299 the clinic are physicians who specialize in interventional pain
300 management in accordance with the American Society of
301 Interventional Pain Physicians.
302 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
303 apply to any physician who provides professional services in a
304 pain-management clinic that is required to be registered in
305 subsection (1).
306 (a) A physician may not practice medicine in a pain
307 management clinic, as described in subsection (4), if:
308 1. the pain-management clinic is not registered with the
309 department as required by this section.; or
310 2. Effective July 1, 2012, the physician has not
311 successfully completed a pain-medicine fellowship that is
312 accredited by the Accreditation Council for Graduate Medical
313 Education or a pain-medicine residency that is accredited by the
314 Accreditation Council for Graduate Medical Education or, prior
315 to July 1, 2012, does not comply with rules adopted by the
316 board.
317
318 Any physician who qualifies to practice medicine in a pain
319 management clinic pursuant to rules adopted by the Board of
320 Medicine as of July 1, 2012, may continue to practice medicine
321 in a pain-management clinic as long as the physician continues
322 to meet the qualifications set forth in the board rules. A
323 physician who violates this paragraph is subject to disciplinary
324 action by his or her appropriate medical regulatory board.
325 (c) A physician must perform a physical examination of a
326 patient on the same day that he or she dispenses or prescribes a
327 controlled substance to a patient at a pain-management clinic.
328 If the physician prescribes or dispenses more than a 72-hour
329 dose of controlled substances for the treatment of chronic
330 nonmalignant pain, the physician must document in the patient’s
331 record the reason such dosage is within the standard of care.
332 For the purpose of this paragraph, the standard of care is set
333 forth in rule 64B8-9.013(3), Florida Administrative Code for
334 prescribing or dispensing that quantity.
335 (5) PENALTIES; ENFORCEMENT.—
336 (f) A licensee or other person who serves as the designated
337 physician of a pain-management clinic as defined in this section
338 or s. 459.0137 and registers a pain-management clinic through
339 misrepresentation or fraud or procures or attempts to procure
340 the registration of a pain-management clinic for any other
341 person by making or causing to be made any false or fraudulent
342 representation commits a felony of the third degree, punishable
343 as provided in s. 775.082, s. 775.083, or s. 775.084.
344 (g) Any person who registers a pain-management clinic
345 through misrepresentation or fraud or who procures or attempts
346 to procure the registration of a pain-management clinic for any
347 other person by making or causing to be made any false or
348 fraudulent representation, commits a felony of the third degree,
349 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
350 Section 8. Paragraphs (f) and (g) are added to subsection
351 (1), paragraphs (g) and (h) are added to subsection (2), and
352 subsection (3) is added to section 458.327, Florida Statutes, to
353 read:
354 458.327 Penalty for violations.—
355 (1) Each of the following acts constitutes a felony of the
356 third degree, punishable as provided in s. 775.082, s. 775.083,
357 or s. 775.084:
358 (f) Failing to perform a physical examination of a patient
359 by a physician or a licensed designee acting under the
360 physician’s supervision on the same day that the treating
361 physician dispenses or prescribes a controlled substance to the
362 patient at a pain-management clinic occurring three or more
363 times within a 6-month period, or failing to perform a physical
364 examination on three or more different patients on the same day
365 that the treating physician dispenses or prescribes a controlled
366 substance to each patient at a pain-management clinic within a
367 6-month period.
368 (g) Prescribing or dispensing in excess of a 72-hour dose
369 of controlled substances for the treatment of chronic
370 nonmalignant pain of a patient occurring three or more times
371 within a 6-month period without documenting in the patient’s
372 record the reason that such dosage is within the standard of
373 care. For the purpose of this paragraph, the standard of care is
374 set forth in rule 64B8-9.013(3), Florida Administrative Code.
375 (2) Each of the following acts constitutes a misdemeanor of
376 the first degree, punishable as provided in s. 775.082 or s.
377 775.083:
378 (g) Failing to perform a physical examination of a patient
379 on the same day that the treating physician dispenses or
380 prescribes a controlled substance to the patient at a pain
381 management clinic two times in a 6-month period, or failing to
382 perform a physical examination on two different patients on the
383 same day that the treating physician dispenses or prescribes a
384 controlled substance to each patient at a pain-management clinic
385 within a 6-month period.
386 (h) Prescribing or dispensing in excess of a 72-hour dose
387 of controlled substances for the treatment of chronic
388 nonmalignant pain of a patient occurring two times within a 6
389 month period without documenting in the patient’s record the
390 reason that such dosage is within the standard of care. For the
391 purpose of this paragraph, the standard of care is set forth in
392 rule 64B8-9.013(3), Florida Administrative Code.
393 (3) Each of the following acts constitutes a misdemeanor of
394 the second degree, punishable as provided in s. 775.082 or s.
395 775.083:
396 (a) A first offense of failing to perform a physical
397 examination of a patient on the same day that the treating
398 physician dispenses or prescribes a controlled substance to the
399 patient at a pain-management clinic.
400 (b) A first offense of failing to document in a patient’s
401 record the reason that such dosage is within the standard of
402 care for prescribing or dispensing in excess of a 72-hour dose
403 of controlled substances for the treatment of chronic
404 nonmalignant pain.
405 Section 9. Subsection (11) is added to section 458.331,
406 Florida Statutes, to read:
407 458.331 Grounds for disciplinary action; action by the
408 board and department.—
409 (11) Notwithstanding subsection (2), upon finding that a
410 physician has prescribed or dispensed, or caused to be
411 prescribed or dispensed, a controlled substance in a pain
412 management clinic in a manner that violates the standard of
413 practice as set forth in chapter 458 or rules adopted pursuant
414 to chapter 458, the board shall, at a minimum, suspend the
415 physician’s license for at least 6 months and impose a fine of
416 at least $10,000 per count. Repeated violations shall result in
417 increased penalties.
418 Section 10. Present subsections (3), (4), and (5) of
419 section 459.003, Florida Statutes, are redesignated as
420 subsections (4), (5), and (6), respectively, and a new
421 subsection (3) is added to that section, to read:
422 459.003 Definitions.—As used in this chapter:
423 (3) “Dispensing physician” means an osteopathic physician
424 who is registered as a dispensing practitioner under s.
425 465.0276.
426 Section 11. Paragraphs (f) and (g) are added to subsection
427 (1), paragraphs (e) and (f) are added to subsection (2), and
428 paragraphs (d) and (e) are added to subsection (3) of section
429 459.013, Florida Statutes, to read:
430 459.013 Penalty for violations.—
431 (1) Each of the following acts constitutes a felony of the
432 third degree, punishable as provided in s. 775.082, s. 775.083,
433 or s. 775.084:
434 (f) Failing to perform a physical examination of a patient
435 on the same day that the osteopathic physician dispenses or
436 prescribes a controlled substance to the patient at a pain
437 management clinic occurring three or more times within a 6-month
438 period, or failing to perform a physical examination on three or
439 more different patients on the same day that the osteopathic
440 physician dispenses or prescribes a controlled substance to each
441 patient at a pain-management clinic within a 6-month period.
442 (g) Prescribing or dispensing in excess of a 72-hour dose
443 of controlled substances for the treatment of chronic
444 nonmalignant pain of a patient occurring three or more times
445 within a 6-month period without documenting in the patient’s
446 record the reason that such dosage is within the standard of
447 care. For the purpose of this paragraph, the standard of care is
448 set forth in rule 64B8-9.013(3), Florida Administrative Code.
449 (2) Each of the following acts constitutes a misdemeanor of
450 the first degree, punishable as provided in s. 775.082 or s.
451 775.083:
452 (e) Failing to perform a physical examination of a patient
453 on the same day that the osteopathic physician dispenses or
454 prescribes a controlled substance to the patient at a pain
455 management clinic occurring two times within a 6-month period,
456 or failing to perform a physical examination on two different
457 patients on the same day that the osteopathic physician
458 dispenses or prescribes a controlled substance to each patient
459 at a pain-management clinic within a 6-month period.
460 (f) Prescribing or dispensing in excess of a 72-hour dose
461 of controlled substances for the treatment of chronic
462 nonmalignant pain of a patient occurring two times within a 6
463 month period without documenting in the patient’s record the
464 reason that such dosage is within the standard of care. For the
465 purpose of this paragraph, the standard of care is set forth in
466 rule 64B8-9.013(3), Florida Administrative Code.
467 (3) Each of the following constitutes a misdemeanor of the
468 second degree, punishable as provided in s. 775.082 or s.
469 775.083:
470 (d) A first offense of failing to perform a physical
471 examination of a patient on the same day that the osteopathic
472 physician dispenses or prescribes a controlled substance to the
473 patient at a pain-management clinic.
474 (e) A first offense of failing to document in a patient’s
475 record the reason that such dosage is within the standard of
476 care for prescribing or dispensing in excess of a 72-hour dose
477 of controlled substances for the treatment of chronic
478 nonmalignant pain. For the purpose of this paragraph, the
479 standard of care is set forth in rule 64B8-9.013(3), Florida
480 Administrative Code.
481 Section 12. Paragraph (c) of subsection (2) of section
482 459.0137, Florida Statutes, is amended, and a new paragraphs (f)
483 and (g) are added to subsection (5) of that section, to read:
484 459.0137 Pain-management clinics.—
485 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
486 apply to any osteopathic physician who provides professional
487 services in a pain-management clinic that is required to be
488 registered in subsection (1).
489 (c) An osteopathic physician must perform a physical
490 examination of a patient on the same day that he or she
491 dispenses or prescribes a controlled substance to a patient at a
492 pain-management clinic. If the osteopathic physician prescribes
493 or dispenses more than a 72-hour dose of controlled substances
494 for the treatment of chronic nonmalignant pain, the osteopathic
495 physician must document in the patient’s record the reason for
496 which prescribing or dispensing a dosage in excess of a 72-hour
497 dose of controlled substances for the treatment of chronic
498 nonmalignant pain is within the standard of care for prescribing
499 or dispensing that quantity.
500 (5) PENALTIES; ENFORCEMENT.—
501 (f) A licensee or other person who serves as the designated
502 physician of a pain-management clinic as defined in s. 458.3265
503 or s. 459.0137 and registers a pain-management clinic through
504 intentional misrepresentation or fraud or procures or attempts
505 to procure the registration of a pain-management clinic for any
506 other person by making or causing to be made any false or
507 fraudulent representation commits a felony of the third degree,
508 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
509 (g) Any person who registers a pain-management clinic
510 through misrepresentation or fraud or who procures or attempts
511 to procure the registration of a pain-management clinic for any
512 other person by making or causing to be made any false or
513 fraudulent representation, commits a felony of the third degree,
514 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
515 Section 13. Subsection (11) is added to section 459.015,
516 Florida Statutes, to read:
517 459.015 Grounds for disciplinary action; action by the
518 board and department.—
519 (11) Notwithstanding subsection (2), upon finding that an
520 osteopathic physician has prescribed or dispensed, or caused to
521 be prescribed or dispensed, a controlled substance in a pain
522 management clinic in a manner that violates the standard of
523 practice as set forth in chapter 459 or rules adopted pursuant
524 to chapter 459, the board shall, at a minimum, suspend the
525 osteopathic physician’s license for at least 6 months and impose
526 a fine of at least $10,000 per count. Repeated violations shall
527 result in increased penalties.
528 Section 14. Subsections (3) and (4) of section 465.015,
529 Florida Statutes, are renumbered as subsections (4) and (5),
530 respectively, and subsection (3) is added to that section, to
531 read:
532 465.015 Violations and penalties.—
533 (3)(a) A licensed pharmacist, pharmacy technician, or any
534 person working under the direction or supervision of a
535 pharmacist or pharmacy technician, may not knowingly fail to
536 timely report to the local county sheriff’s office the name of
537 any person who obtains or attempts to obtain a substance
538 controlled by s. 893.03 which the pharmacist, pharmacy intern,
539 or other person employed by or at a pharmacy knows or reasonably
540 should have known was obtained or attempted to be obtained from
541 the pharmacy through any fraudulent method or representation. A
542 pharmacist, pharmacy intern, or other person employed by or at a
543 pharmacy who fails to make such a report within 24 hours after
544 learning of the fraud or attempted fraud commits a misdemeanor
545 of the first degree, punishable as provided in s. 775.082 or s.
546 775.083.
547 (b) A sufficient report of the fraudulent obtaining of or
548 attempt to obtain a controlled substance under this section must
549 contain, at a minimum, a copy of the prescription used or
550 presented and a narrative, including all information available
551 to the pharmacy regarding:
552 1. The transaction, such as the name and telephone number
553 of the prescribing physician;
554 2. The name, description, and any personal identification
555 information pertaining to the person presenting the
556 prescription; and
557 3. All other material information, such as photographic or
558 video surveillance of the transaction.
559
560 A pharmacist, pharmacy intern, or other person employed by or at
561 a pharmacy is not subject to disciplinary action for reporting
562 under this subsection.
563 Section 15. Subsection (6) is added to section 465.0276,
564 Florida Statutes, to read:
565 465.0276 Dispensing practitioner.—
566 (6) In order to dispense a controlled substance listed in
567 Schedule II, Schedule III, or Schedule IV in s. 893.03, a
568 practitioner authorized by law to prescribe a controlled
569 substance shall register with the Board of Pharmacy as a
570 dispensing practitioner who dispenses controlled substances and
571 pay a fee not to exceed $100. The department shall adopt rules
572 establishing procedures for renewal of the registration every 4
573 years.
574 Section 16. Paragraph (a) of subsection (1) of section
575 766.101, Florida Statutes, is amended to read:
576 766.101 Medical review committee, immunity from liability.—
577 (1) As used in this section:
578 (a) The term “medical review committee” or “committee”
579 means:
580 1.a. A committee of a hospital or ambulatory surgical
581 center licensed under chapter 395 or a health maintenance
582 organization certificated under part I of chapter 641,
583 b. A committee of a physician-hospital organization, a
584 provider-sponsored organization, or an integrated delivery
585 system,
586 c. A committee of a state or local professional society of
587 health care providers,
588 d. A committee of a medical staff of a licensed hospital or
589 nursing home, provided the medical staff operates pursuant to
590 written bylaws that have been approved by the governing board of
591 the hospital or nursing home,
592 e. A committee of the Department of Corrections or the
593 Correctional Medical Authority as created under s. 945.602, or
594 employees, agents, or consultants of either the department or
595 the authority or both,
596 f. A committee of a professional service corporation formed
597 under chapter 621 or a corporation organized under chapter 607
598 or chapter 617, which is formed and operated for the practice of
599 medicine as defined in s. 458.305(4) s. 458.305(3), and which
600 has at least 25 health care providers who routinely provide
601 health care services directly to patients,
602 g. A committee of the Department of Children and Family
603 Services which includes employees, agents, or consultants to the
604 department as deemed necessary to provide peer review,
605 utilization review, and mortality review of treatment services
606 provided pursuant to chapters 394, 397, and 916,
607 h. A committee of a mental health treatment facility
608 licensed under chapter 394 or a community mental health center
609 as defined in s. 394.907, provided the quality assurance program
610 operates pursuant to the guidelines which have been approved by
611 the governing board of the agency,
612 i. A committee of a substance abuse treatment and education
613 prevention program licensed under chapter 397 provided the
614 quality assurance program operates pursuant to the guidelines
615 which have been approved by the governing board of the agency,
616 j. A peer review or utilization review committee organized
617 under chapter 440,
618 k. A committee of the Department of Health, a county health
619 department, healthy start coalition, or certified rural health
620 network, when reviewing quality of care, or employees of these
621 entities when reviewing mortality records, or
622 l. A continuous quality improvement committee of a pharmacy
623 licensed pursuant to chapter 465,
624
625 which committee is formed to evaluate and improve the quality of
626 health care rendered by providers of health service, to
627 determine that health services rendered were professionally
628 indicated or were performed in compliance with the applicable
629 standard of care, or that the cost of health care rendered was
630 considered reasonable by the providers of professional health
631 services in the area; or
632 2. A committee of an insurer, self-insurer, or joint
633 underwriting association of medical malpractice insurance, or
634 other persons conducting review under s. 766.106.
635 Section 17. Subsection (3) of section 810.02, Florida
636 Statutes, is amended to read:
637 810.02 Burglary.—
638 (3) Burglary is a felony of the second degree, punishable
639 as provided in s. 775.082, s. 775.083, or s. 775.084, if, in the
640 course of committing the offense, the offender does not make an
641 assault or battery and is not and does not become armed with a
642 dangerous weapon or explosive, and the offender enters or
643 remains in a:
644 (a) Dwelling, and there is another person in the dwelling
645 at the time the offender enters or remains;
646 (b) Dwelling, and there is not another person in the
647 dwelling at the time the offender enters or remains;
648 (c) Structure, and there is another person in the structure
649 at the time the offender enters or remains;
650 (d) Conveyance, and there is another person in the
651 conveyance at the time the offender enters or remains; or
652 (e) Authorized emergency vehicle, as defined in s. 316.003;
653 or.
654 (f) Structure or conveyance when the offense intended to be
655 committed is theft of a substance controlled by s. 893.03.
656 Notwithstanding any contrary provisions of law, separate
657 judgments and sentences for burglary with the intent to commit
658 theft of a controlled substance under this paragraph and for any
659 applicable offense for possession of a controlled substance
660 under s. 893.13, or an offense for trafficking in a controlled
661 substance under s. 893.135, may be imposed if all such offenses
662 involve the same amount or amounts of a controlled substance.
663
664 However, if the burglary is committed within a county that is
665 subject to a state of emergency declared by the Governor under
666 chapter 252 after the declaration of emergency is made and the
667 perpetration of the burglary is facilitated by conditions
668 arising from the emergency, the burglary is a felony of the
669 first degree, punishable as provided in s. 775.082, s. 775.083,
670 or s. 775.084. As used in this subsection, the term “conditions
671 arising from the emergency” means civil unrest, power outages,
672 curfews, voluntary or mandatory evacuations, or a reduction in
673 the presence of or response time for first responders or
674 homeland security personnel. A person arrested for committing a
675 burglary within a county that is subject to such a state of
676 emergency may not be released until the person appears before a
677 committing magistrate at a first appearance hearing. For
678 purposes of sentencing under chapter 921, a felony offense that
679 is reclassified under this subsection is ranked one level above
680 the ranking under s. 921.0022 or s. 921.0023 of the offense
681 committed.
682 Section 18. Paragraph (c) of subsection (2) of section
683 812.014, Florida Statutes, is amended to read:
684 812.014 Theft.—
685 (2)
686 (c) It is grand theft of the third degree and a felony of
687 the third degree, punishable as provided in s. 775.082, s.
688 775.083, or s. 775.084, if the property stolen is:
689 1. Valued at $300 or more, but less than $5,000.
690 2. Valued at $5,000 or more, but less than $10,000.
691 3. Valued at $10,000 or more, but less than $20,000.
692 4. A will, codicil, or other testamentary instrument.
693 5. A firearm.
694 6. A motor vehicle, except as provided in paragraph (a).
695 7. Any commercially farmed animal, including any animal of
696 the equine, bovine, or swine class, or other grazing animal, and
697 including aquaculture species raised at a certified aquaculture
698 facility. If the property stolen is aquaculture species raised
699 at a certified aquaculture facility, then a $10,000 fine shall
700 be imposed.
701 8. Any fire extinguisher.
702 9. Any amount of citrus fruit consisting of 2,000 or more
703 individual pieces of fruit.
704 10. Taken from a designated construction site identified by
705 the posting of a sign as provided for in s. 810.09(2)(d).
706 11. Any stop sign.
707 12. Anhydrous ammonia.
708 13. Any amount of a substance controlled by s. 893.03.
709 Notwithstanding any contrary provisions of law, separate
710 judgments and sentences for theft of a controlled substance
711 under this subparagraph, and for any applicable offense for
712 possession of a controlled substance under s. 893.13, or an
713 offense for trafficking in a controlled substance under s.
714 893.135 may be imposed if all such offenses involve the same
715 amount or amounts of controlled substance.
716
717 However, if the property is stolen within a county that is
718 subject to a state of emergency declared by the Governor under
719 chapter 252, the property is stolen after the declaration of
720 emergency is made, and the perpetration of the theft is
721 facilitated by conditions arising from the emergency, the
722 offender commits a felony of the second degree, punishable as
723 provided in s. 775.082, s. 775.083, or s. 775.084, if the
724 property is valued at $5,000 or more, but less than $10,000, as
725 provided under subparagraph 2., or if the property is valued at
726 $10,000 or more, but less than $20,000, as provided under
727 subparagraph 3. As used in this paragraph, the term “conditions
728 arising from the emergency” means civil unrest, power outages,
729 curfews, voluntary or mandatory evacuations, or a reduction in
730 the presence of or the response time for first responders or
731 homeland security personnel. For purposes of sentencing under
732 chapter 921, a felony offense that is reclassified under this
733 paragraph is ranked one level above the ranking under s.
734 921.0022 or s. 921.0023 of the offense committed.
735 Section 19. Section 893.021, Florida Statutes, is created
736 to read:
737 893.021 Adulterated drug.—
738 (1) As used in this chapter, a drug is adulterated if it is
739 a controlled substance that:
740 (a) Has been produced, prepared, packed, and marketed for
741 oral consumption by the manufacturer; and
742 (b) Has had any change to its integrity or composition for
743 use by means of inhalation, injection, or any other form of
744 ingestion not in accordance with the manufacturer’s recommended
745 use, and such mode of use has not been previously directed and
746 approved by the prescribing physician.
747 (2) A physician is not prevented from directing or
748 prescribing a change to the recognized manufactured
749 recommendations for use in a patient who presents a medical need
750 for such a requirement change of any controlled substance. The
751 prescribing physician shall clearly indicate any deviation of
752 the recognized manufacturer’s recommended use of a controlled
753 substance on the original prescription, and the licensed
754 pharmacist shall clearly indicate such deviation on the label of
755 the prescription upon dispensing the controlled substance.
756 Section 20. Paragraphs (c), (d), and (e) of subsection (1)
757 of section 893.04, Florida Statutes, are amended to read:
758 893.04 Pharmacist and practitioner.—
759 (1) A pharmacist, in good faith and in the course of
760 professional practice only, may dispense controlled substances
761 upon a written or oral prescription of a practitioner, under the
762 following conditions:
763 (c) The following information must There shall appear on
764 the face of the prescription or written record of a thereof for
765 the controlled substance the following information:
766 1. The full name and address of the person for whom, or the
767 owner of the animal for which, the controlled substance is
768 dispensed.
769 2. The full name and address of the prescribing
770 practitioner and the practitioner’s federal controlled substance
771 registry number shall be printed thereon.
772 3. If the prescription is for an animal, the species of
773 animal for which the controlled substance is prescribed.
774 4. The name of the controlled substance prescribed and the
775 strength, quantity, and directions for use thereof. The
776 directions for use must specify the authorization by the
777 physician, any instructions requiring the adulteration of the
778 dispensed form of the medication, and the medical necessity for
779 the adulteration in accordance with s. 893.021.
780 5. The number of the prescription, as recorded in the
781 prescription files of the pharmacy in which it is filled.
782 6. The initials of the pharmacist filling the prescription
783 and the date filled.
784 (d) The prescription must shall be retained on file by the
785 proprietor of the pharmacy in which it is filled for a period of
786 2 years.
787 (e) A label bearing the following information must be
788 affixed to the original container in which a controlled
789 substance is delivered as upon a prescription or authorized
790 refill thereof, as hereinafter provided, there shall be a label
791 bearing the following information:
792 1. The name and address of the pharmacy from which such
793 controlled substance was dispensed.
794 2. The date on which the prescription for such controlled
795 substance was filled.
796 3. The number of such prescription, as recorded in the
797 prescription files of the pharmacy in which it is filled.
798 4. The name of the prescribing practitioner.
799 5. The name of the patient for whom, or of the owner and
800 species of the animal for which, the controlled substance is
801 prescribed.
802 6. The directions for the use of the controlled substance
803 prescribed in the prescription.
804 7. A clear, concise warning that it is a crime to transfer
805 the controlled substance to any person other than the patient
806 for whom prescribed.
807 Section 21. Section 893.055, Florida Statutes, is amended
808 to read:
809 893.055 Prescription drug monitoring program.—
810 (1) As used in this section, the term:
811 (a) “Patient advisory report” or “advisory report” means
812 information provided by the department in writing, or as
813 determined by the department, to a prescriber, dispenser,
814 pharmacy, or patient concerning the dispensing of controlled
815 substances. All advisory reports are for informational purposes
816 only and impose no obligations of any nature or any legal duty
817 on a prescriber, dispenser, pharmacy, or patient. The patient
818 advisory report shall be provided in accordance with s.
819 893.13(7)(a)8. The advisory reports issued by the department are
820 not subject to discovery or introduction into evidence in any
821 civil or administrative action against a prescriber, dispenser,
822 pharmacy, or patient arising out of matters that are the subject
823 of the report; and a person who participates in preparing,
824 reviewing, issuing, or any other activity related to an advisory
825 report may not be permitted or required to testify in any such
826 civil action as to any findings, recommendations, evaluations,
827 opinions, or other actions taken in connection with preparing,
828 reviewing, or issuing such a report.
829 (b) “Controlled substance” means a controlled substance
830 listed in Schedule II, Schedule III, or Schedule IV in s.
831 893.03.
832 (c) “Dispenser” means a pharmacy, dispensing pharmacist, or
833 dispensing health care practitioner.
834 (d) “Health care practitioner” or “practitioner” means any
835 practitioner who is subject to licensure or regulation by the
836 department under chapter 458, chapter 459, chapter 461, chapter
837 462, chapter 464, chapter 465, or chapter 466.
838 (e) “Health care regulatory board” means any board for a
839 practitioner or health care practitioner who is licensed or
840 regulated by the department.
841 (f) “Pharmacy” means any pharmacy that is subject to
842 licensure or regulation by the department under chapter 465 and
843 that dispenses or delivers a controlled substance to an
844 individual or address in this state.
845 (g) “Prescriber” means a prescribing physician, prescribing
846 practitioner, or other prescribing health care practitioner.
847 (h) “Active investigation” means an investigation that is
848 being conducted with a reasonable, good faith belief that it
849 could lead to the filing of administrative, civil, or criminal
850 proceedings, or that is ongoing and continuing and for which
851 there is a reasonable, good faith anticipation of securing an
852 arrest or prosecution in the foreseeable future.
853 (i) “Law enforcement agency” means the Department of Law
854 Enforcement, a Florida sheriff’s department, a Florida police
855 department, or a law enforcement agency of the Federal
856 Government which enforces the laws of this state or the United
857 States relating to controlled substances, and which its agents
858 and officers are empowered by law to conduct criminal
859 investigations and make arrests.
860 (j) “Program manager” means an employee of or a person
861 contracted by the Department of Health who is designated to
862 ensure the integrity of the prescription drug monitoring program
863 in accordance with the requirements established in paragraphs
864 (2)(a) and (b).
865 (2)(a) By December 1, 2010, the department shall design and
866 establish a comprehensive electronic database system that has
867 controlled substance prescriptions provided to it and that
868 provides prescription information to a patient’s health care
869 practitioner and pharmacist who inform the department that they
870 wish the patient advisory report provided to them. Otherwise,
871 the patient advisory report will not be sent to the
872 practitioner, pharmacy, or pharmacist. The system shall be
873 designed to provide information regarding dispensed
874 prescriptions of controlled substances and shall not infringe
875 upon the legitimate prescribing or dispensing of a controlled
876 substance by a prescriber or dispenser acting in good faith and
877 in the course of professional practice. The system shall be
878 consistent with standards of the American Society for Automation
879 in Pharmacy (ASAP). The electronic system shall also comply with
880 the Health Insurance Portability and Accountability Act (HIPAA)
881 as it pertains to protected health information (PHI), electronic
882 protected health information (EPHI), the National All Schedules
883 Prescription Electronic Reporting (NASPER) Act’s minimum
884 requirements for authentication of a practitioner who requests
885 information in the prescription drug monitoring program database
886 and certification of the purpose for which information is
887 requested, and all other relevant state and federal privacy and
888 security laws and regulations. The department shall establish
889 policies and procedures as appropriate regarding the reporting,
890 accessing the database, evaluation, management, development,
891 implementation, operation, storage, and security of information
892 within the system. The reporting of prescribed controlled
893 substances shall include a dispensing transaction with a
894 dispenser pursuant to chapter 465 or through a dispensing
895 transaction to an individual or address in this state with a
896 pharmacy that is not located in this state but that is otherwise
897 subject to the jurisdiction of this state as to that dispensing
898 transaction. The reporting of patient advisory reports refers
899 only to reports to patients, pharmacies, and practitioners.
900 Separate reports that contain patient prescription history
901 information and that are not patient advisory reports are
902 provided to persons and entities as authorized in paragraphs
903 (7)(b) and (c) and s. 893.0551.
904 (b) The department, when the direct support organization
905 receives at least $20,000 in nonstate moneys or the state
906 receives at least $20,000 in federal grants for the prescription
907 drug monitoring program, and in consultation with the Office of
908 Drug Control, shall adopt rules as necessary concerning the
909 reporting, accessing the database, evaluation, management,
910 development, implementation, operation, security, and storage of
911 information within the system, including rules for when patient
912 advisory reports are provided to pharmacies and prescribers. The
913 patient advisory report shall be provided in accordance with s.
914 893.13(7)(a)8. The department shall work with the professional
915 health care licensure boards, such as the Board of Medicine, the
916 Board of Osteopathic Medicine, and the Board of Pharmacy; other
917 appropriate organizations, such as the Florida Pharmacy
918 Association, the Office of Drug Control, the Florida Medical
919 Association, the Florida Retail Federation, and the Florida
920 Osteopathic Medical Association, including those relating to
921 pain management; and the Attorney General, the Department of Law
922 Enforcement, and the Agency for Health Care Administration to
923 develop rules appropriate for the prescription drug monitoring
924 program.
925 (c) All dispensers and prescribers subject to these
926 reporting requirements shall be notified by the department of
927 the implementation date for such reporting requirements.
928 (d) The program manager shall work with professional health
929 care licensure boards and the stakeholders listed in paragraph
930 (b) to develop rules appropriate for identifying indicators of
931 controlled substance abuse.
932 (e) The department shall establish a method to allow
933 corrections to the database when notified by a health care
934 practitioner or pharmacist.
935 (3) The pharmacy dispensing the controlled substance and
936 each prescriber who directly dispenses a controlled substance
937 shall submit to the electronic system, by a procedure and in a
938 format established by the department and consistent with an
939 ASAP-approved format, the following information for inclusion in
940 the database:
941 (a) The name of the prescribing practitioner, the
942 practitioner’s federal Drug Enforcement Administration
943 registration number, the practitioner’s National Provider
944 Identification (NPI) or other appropriate identifier, and the
945 date of the prescription.
946 (b) The date the prescription was filled and the method of
947 payment, such as cash by an individual, insurance coverage
948 through a third party, or Medicaid payment. This paragraph does
949 not authorize the department to include individual credit card
950 numbers or other account numbers in the database.
951 (c) The full name, address, and date of birth of the person
952 for whom the prescription was written.
953 (d) The name, national drug code, quantity, and strength of
954 the controlled substance dispensed.
955 (e) The full name, federal Drug Enforcement Administration
956 registration number, and address of the pharmacy or other
957 location from which the controlled substance was dispensed. If
958 the controlled substance was dispensed by a practitioner other
959 than a pharmacist, the practitioner’s full name, federal Drug
960 Enforcement Administration registration number, and address.
961 (f) The name of the pharmacy or practitioner, other than a
962 pharmacist, dispensing the controlled substance and the
963 practitioner’s National Provider Identification (NPI).
964 (g) Other appropriate identifying information as determined
965 by department rule.
966 (h) The number of refills ordered and whether the drug was
967 dispensed as a refill of a prescription or was a first-time
968 request.
969 (4) Each time a controlled substance is dispensed to an
970 individual, the controlled substance shall be reported to the
971 department through the system as soon thereafter as possible,
972 but not more than 7 15 days after the date the controlled
973 substance is dispensed unless an extension is approved by the
974 department for cause as determined by rule. A dispenser must
975 meet the reporting requirements of this section by providing the
976 required information concerning each controlled substance that
977 it dispensed in a department-approved, secure methodology and
978 format. Such approved formats may include, but are not limited
979 to, submission via the Internet, on a disc, or by use of regular
980 mail.
981 (5) When the following acts of dispensing or administering
982 occur, the following are exempt from reporting under this
983 section for that specific act of dispensing or administration:
984 (a) A health care practitioner when administering a
985 controlled substance directly to a patient if the amount of the
986 controlled substance is adequate to treat the patient during
987 that particular treatment session.
988 (b) A pharmacist or health care practitioner when
989 administering a controlled substance to a patient or resident
990 receiving care as a patient at a hospital, nursing home,
991 ambulatory surgical center, hospice, or intermediate care
992 facility for the developmentally disabled which is licensed in
993 this state.
994 (c) A practitioner when administering or dispensing a
995 controlled substance in the health care system of the Department
996 of Corrections.
997 (c)(d) A practitioner when administering a controlled
998 substance in the emergency room of a licensed hospital.
999 (d)(e) A health care practitioner when administering or
1000 dispensing a controlled substance to a person under the age of
1001 16 if the amount of the controlled substance is adequate to
1002 treat the patient during that particular treatment session.
1003 (e)(f) A pharmacist or a dispensing practitioner when
1004 dispensing a one-time, 48-hour 72-hour emergency resupply of a
1005 controlled substance to a patient.
1006 (6) The department may establish when to suspend and when
1007 to resume reporting information during a state-declared or
1008 nationally declared disaster.
1009 (7)(a) A practitioner or pharmacist who dispenses a
1010 controlled substance must submit the information required by
1011 this section in an electronic or other method in an ASAP format
1012 approved by rule of the department unless otherwise provided in
1013 this section. The cost to the dispenser in submitting the
1014 information required by this section may not be material or
1015 extraordinary. Costs not considered to be material or
1016 extraordinary include, but are not limited to, regular postage,
1017 electronic media, regular electronic mail, and facsimile
1018 charges.
1019 (b)1. In order for a pharmacy, prescriber, practitioner, or
1020 dispenser to shall have access to information in the
1021 prescription drug monitoring program’s database which relates to
1022 a patient of that pharmacy, prescriber, practitioner, or
1023 dispenser, the pharmacy, prescriber, practitioner, or dispenser
1024 shall register with the department by submitting a registering
1025 document provided by the department. The document and validation
1026 of that document shall be determined by the department. Before a
1027 pharmacy, prescriber, practitioner, or dispenser is granted
1028 access to information in the database from the prescription drug
1029 monitoring program, the department shall approve the submitted
1030 document. Upon approval, the department shall grant the
1031 registrant access to the appropriate information in the
1032 prescription drug monitoring program’s database in a manner
1033 established by the department as needed for the purpose of
1034 reviewing the patient’s controlled substance prescription
1035 history.
1036 2. Other access to the program’s database shall be limited
1037 to the program’s manager and to the designated program and
1038 support staff, who may act only at the direction of the program
1039 manager or, in the absence of the program manager, as
1040 authorized. Access by the program manager or such designated
1041 staff is for prescription drug program management only or for
1042 management of the program’s database and its system in support
1043 of the requirements of this section and in furtherance of the
1044 prescription drug monitoring program. Confidential and exempt
1045 information in the database shall be released only as provided
1046 in paragraph (c) and s. 893.0551. The program manager,
1047 designated program and support staff who act at the direction of
1048 or in the absence of the program manager, and any individual who
1049 has similar access regarding the management of the database from
1050 the prescription drug monitoring program shall submit
1051 fingerprints to the department for background screening. The
1052 department shall follow the procedure established by the
1053 Department of Law Enforcement to request a statewide criminal
1054 history record check and to request that the Department of Law
1055 Enforcement forward the fingerprints to the Federal Bureau of
1056 Investigation for a national criminal history record check.
1057 (c) The following entities may shall not have be allowed
1058 direct access to information in the prescription drug monitoring
1059 program database but may request from the program manager and,
1060 when authorized by the program manager, the program manager’s
1061 program and support staff, information that is confidential and
1062 exempt under s. 893.0551. Prior to release, the request shall be
1063 verified as authentic and authorized with the requesting
1064 organization by the program manager, the program manager’s
1065 program and support staff, or as determined in rules by the
1066 department as being authentic and as having been authorized by
1067 the requesting entity:
1068 1. The department or its relevant health care regulatory
1069 boards responsible for the licensure, regulation, or discipline
1070 of practitioners, pharmacists, or other persons who are
1071 authorized to prescribe, administer, or dispense controlled
1072 substances and who are involved in a specific controlled
1073 substance investigation involving a designated person for one or
1074 more prescribed controlled substances.
1075 2. The Attorney General for Medicaid fraud cases or
1076 Medicaid investigations involving prescribed controlled
1077 substances.
1078 3. A law enforcement agency during active investigations
1079 regarding potential criminal activity, fraud, or theft regarding
1080 prescribed controlled substances.
1081 4. A patient or the legal guardian or designated health
1082 care surrogate of an incapacitated patient as described in s.
1083 893.0551 who, for the purpose of verifying the accuracy of the
1084 database information, submits a written and notarized request
1085 that includes the patient’s full name, address, and date of
1086 birth, and includes the same information if the legal guardian
1087 or health care surrogate submits the request. The patient’s
1088 phone number, current address, and a copy of a government-issued
1089 photo identification must be provided in person to the program
1090 manager along with the notarized request. The request shall be
1091 validated by the department to verify the identity of the
1092 patient and the legal guardian or health care surrogate, if the
1093 patient’s legal guardian or health care surrogate is the
1094 requestor. Such verification is also required for any request to
1095 change a patient’s prescription history or other information
1096 related to his or her information in the electronic database.
1097 5. The Agency for Health Care Administration for Medicaid
1098 fraud cases or Medicaid investigations involving prescribed
1099 controlled substances.
1100
1101 Information in the database for the electronic prescription drug
1102 monitoring system is not discoverable or admissible in any civil
1103 or administrative action, except in an investigation and
1104 disciplinary proceeding by the department or the appropriate
1105 regulatory board.
1106 (d) The following entities may shall not have be allowed
1107 direct access to information in the prescription drug monitoring
1108 program database but may request from the program manager and,
1109 when authorized by the program manager, the program manager’s
1110 program and support staff, information that contains no
1111 identifying information of any patient, physician, health care
1112 practitioner, prescriber, or dispenser and that is not
1113 confidential and exempt:
1114 1. Department staff for the purpose of calculating
1115 performance measures pursuant to subsection (8).
1116 2. The Program Implementation and Oversight Task Force for
1117 its reporting to the Governor, the President of the Senate, and
1118 the Speaker of the House of Representatives regarding the
1119 prescription drug monitoring program. This subparagraph expires
1120 July 1, 2012.
1121 (e) All transmissions of data required by this section must
1122 comply with relevant state and federal privacy and security laws
1123 and regulations. However, any authorized agency or person under
1124 s. 893.0551 receiving such information as allowed by s. 893.0551
1125 may maintain the information received for up to 24 months before
1126 purging it from his or her records or maintain it for longer
1127 than 24 months if the information is pertinent to ongoing health
1128 care or an active law enforcement investigation or prosecution.
1129 (f) The program manager, upon determining a pattern
1130 consistent with the rules established under paragraph (2)(d) and
1131 having cause to believe a violation of s. 893.13(7)(a)8.,
1132 (8)(a), or (8)(b) has occurred, may provide relevant information
1133 to the applicable law enforcement agency.
1134 (8) To assist in fulfilling program responsibilities,
1135 performance measures shall be reported annually to the Governor,
1136 the President of the Senate, and the Speaker of the House of
1137 Representatives by the department each December 1, beginning in
1138 2011. Data that does not contain patient, physician, health care
1139 practitioner, prescriber, or dispenser identifying information
1140 may be requested during the year by department employees so that
1141 the department may undertake public health care and safety
1142 initiatives that take advantage of observed trends. Performance
1143 measures may include, but are not limited to, efforts to achieve
1144 the following outcomes:
1145 (a) Reduction of the rate of inappropriate use of
1146 prescription drugs through department education and safety
1147 efforts.
1148 (b) Reduction of the quantity of pharmaceutical controlled
1149 substances obtained by individuals attempting to engage in fraud
1150 and deceit.
1151 (c) Increased coordination among partners participating in
1152 the prescription drug monitoring program.
1153 (d) Involvement of stakeholders in achieving improved
1154 patient health care and safety and reduction of prescription
1155 drug abuse and prescription drug diversion.
1156 (9) Any person who willfully and knowingly fails to report
1157 the dispensing of a controlled substance as required by this
1158 section commits a misdemeanor of the first degree, punishable as
1159 provided in s. 775.082 or s. 775.083.
1160 (10) All costs incurred by the department in administering
1161 the prescription drug monitoring program shall be funded through
1162 federal grants or private funding applied for or received by the
1163 state. The department may not commit funds for the monitoring
1164 program without ensuring funding is available. The prescription
1165 drug monitoring program and the implementation thereof are
1166 contingent upon receipt of the nonstate funding. The department
1167 and state government shall cooperate with the direct-support
1168 organization established pursuant to subsection (11) in seeking
1169 federal grant funds, other nonstate grant funds, gifts,
1170 donations, or other private moneys for the department so long as
1171 the costs of doing so are not considered material. Nonmaterial
1172 costs for this purpose include, but are not limited to, the
1173 costs of mailing and personnel assigned to research or apply for
1174 a grant. Notwithstanding the exemptions to competitive
1175 solicitation requirements under s. 287.057(3)(f), the department
1176 shall comply with the competitive-solicitation requirements
1177 under s. 287.057 for the procurement of any goods or services
1178 required by this section.
1179 (11) The Office of Drug Control, in coordination with the
1180 department, may establish a direct-support organization that has
1181 a board consisting of at least five members to provide
1182 assistance, funding, and promotional support for the activities
1183 authorized for the prescription drug monitoring program.
1184 (a) As used in this subsection, the term “direct-support
1185 organization” means an organization that is:
1186 1. A Florida corporation not for profit incorporated under
1187 chapter 617, exempted from filing fees, and approved by the
1188 Department of State.
1189 2. Organized and operated to conduct programs and
1190 activities; raise funds; request and receive grants, gifts, and
1191 bequests of money; acquire, receive, hold, and invest, in its
1192 own name, securities, funds, objects of value, or other
1193 property, either real or personal; and make expenditures or
1194 provide funding to or for the direct or indirect benefit of the
1195 department in the furtherance of the prescription drug
1196 monitoring program.
1197 (b) The direct-support organization is not considered a
1198 lobbying firm within the meaning of s. 11.045.
1199 (c) The director of the Office of Drug Control shall
1200 appoint a board of directors for the direct-support
1201 organization. The director may designate employees of the Office
1202 of Drug Control, state employees other than state employees from
1203 the department, and any other nonstate employees as appropriate,
1204 to serve on the board. Members of the board shall serve at the
1205 pleasure of the director of the Office of Drug Control. The
1206 director shall provide guidance to members of the board to
1207 ensure that moneys received by the direct-support organization
1208 are not received from inappropriate sources. Inappropriate
1209 sources include, but are not limited to, donors, grantors,
1210 persons, or organizations that may monetarily or substantively
1211 benefit from the purchase of goods or services by the department
1212 in furtherance of the prescription drug monitoring program.
1213 (d) The direct-support organization shall operate under
1214 written contract with the Office of Drug Control. The contract
1215 must, at a minimum, provide for:
1216 1. Approval of the articles of incorporation and bylaws of
1217 the direct-support organization by the Office of Drug Control.
1218 2. Submission of an annual budget for the approval of the
1219 Office of Drug Control.
1220 3. Certification by the Office of Drug Control in
1221 consultation with the department that the direct-support
1222 organization is complying with the terms of the contract in a
1223 manner consistent with and in furtherance of the goals and
1224 purposes of the prescription drug monitoring program and in the
1225 best interests of the state. Such certification must be made
1226 annually and reported in the official minutes of a meeting of
1227 the direct-support organization.
1228 4. The reversion, without penalty, to the Office of Drug
1229 Control, or to the state if the Office of Drug Control ceases to
1230 exist, of all moneys and property held in trust by the direct
1231 support organization for the benefit of the prescription drug
1232 monitoring program if the direct-support organization ceases to
1233 exist or if the contract is terminated.
1234 5. The fiscal year of the direct-support organization,
1235 which must begin July 1 of each year and end June 30 of the
1236 following year.
1237 6. The disclosure of the material provisions of the
1238 contract to donors of gifts, contributions, or bequests,
1239 including such disclosure on all promotional and fundraising
1240 publications, and an explanation to such donors of the
1241 distinction between the Office of Drug Control and the direct
1242 support organization.
1243 7. The direct-support organization’s collecting, expending,
1244 and providing of funds to the department for the development,
1245 implementation, and operation of the prescription drug
1246 monitoring program as described in this section and s. 2,
1247 chapter 2009-198, Laws of Florida, as long as the task force is
1248 authorized. The direct-support organization may collect and
1249 expend funds to be used for the functions of the direct-support
1250 organization’s board of directors, as necessary and approved by
1251 the director of the Office of Drug Control. In addition, the
1252 direct-support organization may collect and provide funding to
1253 the department in furtherance of the prescription drug
1254 monitoring program by:
1255 a. Establishing and administering the prescription drug
1256 monitoring program’s electronic database, including hardware and
1257 software.
1258 b. Conducting studies on the efficiency and effectiveness
1259 of the program to include feasibility studies as described in
1260 subsection (13).
1261 c. Providing funds for future enhancements of the program
1262 within the intent of this section.
1263 d. Providing user training of the prescription drug
1264 monitoring program, including distribution of materials to
1265 promote public awareness and education and conducting workshops
1266 or other meetings, for health care practitioners, pharmacists,
1267 and others as appropriate.
1268 e. Providing funds for travel expenses.
1269 f. Providing funds for administrative costs, including
1270 personnel, audits, facilities, and equipment.
1271 g. Fulfilling all other requirements necessary to implement
1272 and operate the program as outlined in this section.
1273 (e) The activities of the direct-support organization must
1274 be consistent with the goals and mission of the Office of Drug
1275 Control, as determined by the office in consultation with the
1276 department, and in the best interests of the state. The direct
1277 support organization must obtain a written approval from the
1278 director of the Office of Drug Control for any activities in
1279 support of the prescription drug monitoring program before
1280 undertaking those activities.
1281 (f) The Office of Drug Control, in consultation with the
1282 department, may permit, without charge, appropriate use of
1283 administrative services, property, and facilities of the Office
1284 of Drug Control and the department by the direct-support
1285 organization, subject to this section. The use must be directly
1286 in keeping with the approved purposes of the direct-support
1287 organization and may not be made at times or places that would
1288 unreasonably interfere with opportunities for the public to use
1289 such facilities for established purposes. Any moneys received
1290 from rentals of facilities and properties managed by the Office
1291 of Drug Control and the department may be held by the Office of
1292 Drug Control or in a separate depository account in the name of
1293 the direct-support organization and subject to the provisions of
1294 the letter of agreement with the Office of Drug Control. The
1295 letter of agreement must provide that any funds held in the
1296 separate depository account in the name of the direct-support
1297 organization must revert to the Office of Drug Control if the
1298 direct-support organization is no longer approved by the Office
1299 of Drug Control to operate in the best interests of the state.
1300 (g) The Office of Drug Control, in consultation with the
1301 department, may adopt rules under s. 120.54 to govern the use of
1302 administrative services, property, or facilities of the
1303 department or office by the direct-support organization.
1304 (h) The Office of Drug Control may not permit the use of
1305 any administrative services, property, or facilities of the
1306 state by a direct-support organization if that organization does
1307 not provide equal membership and employment opportunities to all
1308 persons regardless of race, color, religion, gender, age, or
1309 national origin.
1310 (i) The direct-support organization shall provide for an
1311 independent annual financial audit in accordance with s.
1312 215.981. Copies of the audit shall be provided to the Office of
1313 Drug Control and the Office of Policy and Budget in the
1314 Executive Office of the Governor.
1315 (j) The direct-support organization may not exercise any
1316 power under s. 617.0302(12) or (16).
1317 (12) A prescriber or dispenser may have access to the
1318 information under this section which relates to a patient of
1319 that prescriber or dispenser as needed for the purpose of
1320 reviewing the patient’s controlled drug prescription history. A
1321 prescriber or dispenser acting in good faith is immune from any
1322 civil, criminal, or administrative liability that might
1323 otherwise be incurred or imposed for receiving or using
1324 information from the prescription drug monitoring program. This
1325 subsection does not create a private cause of action, and a
1326 person may not recover damages against a prescriber or dispenser
1327 authorized to access information under this subsection for
1328 accessing or failing to access such information.
1329 (13) To the extent that funding is provided for such
1330 purpose through federal or private grants or gifts and other
1331 types of available moneys, the department, in collaboration with
1332 the Office of Drug Control, shall study the feasibility of
1333 enhancing the prescription drug monitoring program for the
1334 purposes of public health initiatives and statistical reporting
1335 that respects the privacy of the patient, the prescriber, and
1336 the dispenser. Such a study shall be conducted in order to
1337 further improve the quality of health care services and safety
1338 by improving the prescribing and dispensing practices for
1339 prescription drugs, taking advantage of advances in technology,
1340 reducing duplicative prescriptions and the overprescribing of
1341 prescription drugs, and reducing drug abuse. The requirements of
1342 the National All Schedules Prescription Electronic Reporting
1343 (NASPER) Act are authorized in order to apply for federal NASPER
1344 funding. In addition, the direct-support organization shall
1345 provide funding for the department, in collaboration with the
1346 Office of Drug Control, to conduct training for health care
1347 practitioners and other appropriate persons in using the
1348 monitoring program to support the program enhancements.
1349 (14) A pharmacist, pharmacy, or dispensing health care
1350 practitioner or his or her agent, before releasing a controlled
1351 substance to any person not known to such dispenser, shall
1352 require the person purchasing, receiving, or otherwise acquiring
1353 the controlled substance to present valid photographic
1354 identification or other verification of his or her identity to
1355 the dispenser. If the person does not have proper
1356 identification, the dispenser may verify the validity of the
1357 prescription and the identity of the patient with the prescriber
1358 or his or her authorized agent. Verification of health plan
1359 eligibility through a real-time inquiry or adjudication system
1360 will be considered to be proper identification. This subsection
1361 does not apply in an institutional setting or to a long-term
1362 care facility, including, but not limited to, an assisted living
1363 facility or a hospital to which patients are admitted. As used
1364 in this subsection, the term “proper identification” means an
1365 identification that is issued by a state or the Federal
1366 Government containing the person’s photograph, printed name, and
1367 signature or a document considered acceptable under 8 C.F.R. s.
1368 274a.2(b)(1)(v)(A) and (B).
1369 (15) The Agency for Health Care Administration shall
1370 continue the promotion of electronic prescribing by health care
1371 practitioners, health care facilities, and pharmacies under s.
1372 408.0611.
1373 (16) By October 1, 2010, the department shall adopt rules
1374 pursuant to ss. 120.536(1) and 120.54 to administer the
1375 provisions of this section, which shall include as necessary the
1376 reporting, accessing, evaluation, management, development,
1377 implementation, operation, and storage of information within the
1378 monitoring program’s system.
1379 (17) After the prescription drug monitoring program has
1380 been operational for 12 months, the State Surgeon General shall
1381 enter into reciprocal agreements for the sharing of prescription
1382 drug monitoring information with any other state that has a
1383 compatible prescription drug monitoring program. If the State
1384 Surgeon General evaluates the prescription drug monitoring
1385 program of another state as authorized in this subsection,
1386 priority shall be given to a state that is contiguous with the
1387 borders of this state.
1388 (a) In determining compatibility, the State Surgeon General
1389 shall consider:
1390 1. The essential purposes of the program and the success of
1391 the program in fulfilling those purposes.
1392 2. The safeguards for privacy of patient records and the
1393 success of the program in protecting patient privacy.
1394 3. The persons authorized to view the data collected by the
1395 program. Comparable organizations and professions for
1396 practitioners in other states, law enforcement agencies, the
1397 Attorney General’s Medicaid Fraud Unit, medical regulatory
1398 boards, and, as needed, management staff who have similar duties
1399 as management staff who work with the prescription drug
1400 monitoring program as authorized in s. 893.0551 are authorized
1401 access upon approval by the State Surgeon General.
1402 4. The schedules of the controlled substances that are
1403 monitored.
1404 5. The data required to be submitted for each prescription.
1405 6. Any implementing criteria deemed essential for a
1406 thorough comparison.
1407 (b) The State Surgeon General shall annually review any
1408 agreement to determine its continued compatibility with the
1409 prescription drug monitoring program in this state.
1410 (c) Any agreement between the State Surgeon General and
1411 another state shall prohibit the sharing of information
1412 concerning a resident of this state or a practitioner,
1413 pharmacist, or other prescriber for any purpose that is not
1414 otherwise authorized by this section or s. 893.0551.
1415 Section 22. Present subsections (4), (5), (6), and (7) of
1416 section 893.0551, Florida Statutes, are redesignated as
1417 subsections (5), (6), (7), and (8), respectively, and a new
1418 subsection (4) is added to that section, to read:
1419 893.0551 Public records exemption for the prescription drug
1420 monitoring program.—
1421 (4) The department may disclose confidential and exempt
1422 information contained in records held by the department under s.
1423 893.055 if the State Surgeon General has entered into a
1424 reciprocal agreement for the sharing of prescription drug
1425 monitoring information with any other state that has a
1426 compatible prescription drug monitoring program.
1427 (a) The reciprocal agreement may allow the following
1428 persons from another state to receive information from the
1429 prescription drug monitoring program if approved by the State
1430 Surgeon General:
1431 1. A designated representative of a state professional
1432 licensing, certification, or regulatory agency charged with
1433 oversight of those persons authorized to prescribe or dispense
1434 controlled substances for the purpose of a bona fide, specific
1435 investigation of a prescription of a controlled substance which
1436 involves a designated person. As required in s. 893.055, this
1437 authorization does not preclude the requirement for the program
1438 manager to review the request for information and validate it.
1439 2. A health care practitioner or pharmacist licensed in the
1440 state from which the request originates. Such health care
1441 practitioner or pharmacist shall certify that the requested
1442 information is for the purpose of providing medical or
1443 pharmaceutical treatment to a bona fide, current patient. The
1444 health care practitioner or pharmacist shall follow all the
1445 procedures required in s. 893.055 and rules established by the
1446 department for a health care practitioner or pharmacist to
1447 request information from the database.
1448 3. A law enforcement officer from another state:
1449 a. Who is a member of a sheriff’s department or a police
1450 department;
1451 b. Who is authorized by law to conduct criminal
1452 investigations and make arrests;
1453 c. Whose duty it is to enforce the laws of his or her state
1454 relating to controlled substances; and
1455 d. Who is engaged in a bona fide specific, active
1456 investigation involving a designated person regarding
1457 prescriptions for controlled substances.
1458
1459 As required in s. 893.055, this authorization does not preclude
1460 the requirement for the program manager to review the request
1461 for information and validate it. This authorization also does
1462 not preclude the ability to provide a report to a law
1463 enforcement agency in another state under s. 893.055(7) or this
1464 subsection.
1465 (b) Any agreement between the State Surgeon General and
1466 another state shall prohibit the sharing of information
1467 concerning a resident of this state, a patient whose information
1468 is in the program’s database, or a practitioner, pharmacy,
1469 pharmacist, health care practitioner, or other prescriber for
1470 any purpose that is not otherwise authorized by this section or
1471 s. 893.055, and the information must be provided according to
1472 the State Surgeon General’s determination of compatibility as
1473 described in s. 893.055(17).
1474 Section 23. Subsections (1), (4), and (5) of section
1475 893.07, Florida Statutes, are amended, and a new subsection (6)
1476 is added to that section to read:
1477 893.07 Records.—
1478 (1) Notwithstanding any other provision of law and in
1479 consonance with the authority of State v. Carter, 23 So. 3d 798
1480 (Fla. 1st DCA 2009) and State v. Tamulonis, 39 So. 3d 524 (Fla.
1481 2nd DCA 2010), every person who engages in the manufacture,
1482 compounding, mixing, cultivating, growing, or by any other
1483 process producing or preparing, or in the dispensing,
1484 importation, or, as a wholesaler, distribution, of controlled
1485 substances shall:
1486 (a) On January 1, 1974, or as soon thereafter as any person
1487 first engages in such activity, and every second year
1488 thereafter, make a complete and accurate record of all stocks of
1489 controlled substances on hand. The inventory may be prepared on
1490 the regular physical inventory date which is nearest to, and
1491 does not vary by more than 6 months from, the biennial date that
1492 would otherwise apply. As additional substances are designated
1493 for control under this chapter, they shall be inventoried as
1494 provided for in this subsection.
1495 (b) On and after January 1, 1974, maintain, on a current
1496 basis, a complete and accurate record of each substance
1497 manufactured, received, sold, delivered, or otherwise disposed
1498 of by him or her, except that this subsection shall not require
1499 the maintenance of a perpetual inventory.
1500
1501 Compliance with the provisions of federal law pertaining to the
1502 keeping of records of controlled substances shall be deemed a
1503 compliance with the requirements of this subsection.
1504 (4) Every inventory or record required by this chapter,
1505 including prescription records, shall be maintained:
1506 (a) Separately from all other records of the registrant, or
1507 (b) Alternatively, in the case of Schedule III, IV, or V
1508 controlled substances, in such form that information required by
1509 this chapter is readily retrievable from the ordinary business
1510 records of the registrant.
1511
1512 In either case, such records described in this subsection shall
1513 be kept and made available for a period of at least 2 years for
1514 inspection and copying by law enforcement officers whose duty it
1515 is to enforce the laws of this state relating to controlled
1516 substances. This subsection does not require a law enforcement
1517 officer to obtain a subpoena, court order, or search warrant in
1518 order to obtain access to or copies of such records.
1519 (5) Each person shall maintain a record that contains which
1520 shall contain a detailed list of controlled substances lost,
1521 destroyed, or stolen, if any; the kind and quantity of such
1522 controlled substances; and the date of the discovering of such
1523 loss, destruction, or theft. If a person discovers the theft or
1524 loss of a controlled substance, such person shall report the
1525 theft or loss to a local county sheriff’s office within 48 hours
1526 after the discovery of such theft or loss. A person who fails to
1527 report the theft or loss of a controlled substance under this
1528 subsection commits a misdemeanor of the second degree,
1529 punishable as provided in s. 775.082 or s. 775.083. However, a
1530 person who fails to report the theft or loss of a Schedule II
1531 controlled substance commits a misdemeanor of the first degree,
1532 punishable as provided in s. 775.082 or s. 775.083.
1533 (6) The Legislature finds that the opinions rendered in
1534 State v. Carter, 23 So. 3d 798 (Fla. 1st DCA 2009), and State v.
1535 Tamulonis, 39 So. 3d 524 (Fla. 2nd DCA 2010), correctly construe
1536 this Legislature’s intent that the inspection powers previously
1537 conferred upon law enforcement officers which allow such
1538 officers to access and review pharmacy records concerning
1539 controlled substances are to be exercised properly by such law
1540 enforcement officers without the requirement of a subpoena or
1541 search warrant being sought or issued to examine and copy such
1542 records, and without the requirement that those persons to whom
1543 particular pharmacy records refer be given notice of the
1544 records’ examination and copying under this section.
1545 Section 24. Subsections (7) and (8) of section 893.13,
1546 Florida Statutes, are amended to read:
1547 893.13 Prohibited acts; penalties.—
1548 (7)(a) A It is unlawful for any person may not:
1549 1. To Distribute or dispense a controlled substance in
1550 violation of this chapter.
1551 2. To Refuse or fail to make, keep, or furnish any record,
1552 notification, order form, statement, invoice, or information
1553 required under this chapter.
1554 3. To Refuse an entry into any premises for any inspection
1555 or to refuse to allow any inspection authorized by this chapter.
1556 4. To Distribute a controlled substance named or described
1557 in s. 893.03(1) or (2) except pursuant to an order form as
1558 required by s. 893.06.
1559 5. To Keep or maintain any store, shop, warehouse,
1560 dwelling, building, vehicle, boat, aircraft, or other structure
1561 or place which is resorted to by persons using controlled
1562 substances in violation of this chapter for the purpose of using
1563 these substances, or which is used for keeping or selling them
1564 in violation of this chapter.
1565 6. To Use to his or her own personal advantage, or to
1566 reveal, any information obtained in enforcement of this chapter
1567 except in a prosecution or administrative hearing for a
1568 violation of this chapter.
1569 7. To Possess a prescription form which has not been
1570 completed and signed by the practitioner whose name appears
1571 printed thereon, unless the person is that practitioner, is an
1572 agent or employee of that practitioner, is a pharmacist, or is a
1573 supplier of prescription forms who is authorized by that
1574 practitioner to possess those forms.
1575 8. To Withhold information from a practitioner from whom
1576 the person seeks to obtain a controlled substance or a
1577 prescription for a controlled substance that the person making
1578 the request has received a controlled substance or a
1579 prescription for a controlled substance of like therapeutic use
1580 from another practitioner within the previous 30 days.
1581 9. To Acquire or obtain, or attempt to acquire or obtain,
1582 possession of a controlled substance by misrepresentation,
1583 fraud, forgery, deception, or subterfuge.
1584 10. To Affix any false or forged label to a package or
1585 receptacle containing a controlled substance.
1586 11. To Furnish false or fraudulent material information in,
1587 or omit any material information from, any report or other
1588 document required to be kept or filed under this chapter or any
1589 record required to be kept by this chapter.
1590 12. To Store anhydrous ammonia in a container that is not
1591 approved by the United States Department of Transportation to
1592 hold anhydrous ammonia or is not constructed in accordance with
1593 sound engineering, agricultural, or commercial practices.
1594 13. With the intent to obtain a controlled substance or
1595 combination of controlled substances that are not medically
1596 necessary for the person or an amount of a controlled substance
1597 or substances that are not medically necessary for the person,
1598 obtain or attempt to obtain from a practitioner a controlled
1599 substance or a prescription for a controlled substance by
1600 misrepresentation, fraud, forgery, deception, subterfuge, or
1601 concealment of a material fact. For purposes of this
1602 subparagraph, a material fact includes whether the person has an
1603 existing prescription for a controlled substance issued for the
1604 same period of time by another practitioner or as described in
1605 subparagraph 8.
1606 (b) A health care practitioner, with the intent to provide
1607 a controlled substance or combination of controlled substances
1608 that are not medically necessary to his or her patient or an
1609 amount of controlled substances that are not medically necessary
1610 for his or her patient, may not provide a controlled substance
1611 or a prescription for a controlled substance by
1612 misrepresentation, fraud, forgery, deception, subterfuge, or
1613 concealment of a material fact. For purposes of this paragraph,
1614 a material fact includes whether the patient has an existing
1615 prescription for a controlled substance issued for the same
1616 period of time by another practitioner or as described in
1617 subparagraph (a)8.
1618 (c) Any person who adulterates a controlled substance for
1619 directed off-label use without authorization by a prescribing
1620 physician violates the provisions of subparagraph (a)1. and
1621 causes the issuance of the entire prescription for the
1622 controlled substance to become invalid. A law enforcement
1623 officer in the performance of his or her official duties may
1624 seize the adulterated or off-label prescribed controlled
1625 substance as evidence. The controlled substance may be returned
1626 to the owner only with a notarized affidavit from the original
1627 prescribing practitioner who has knowledge and gave
1628 authorization and explicit directions for the adulteration or
1629 off-label use of the controlled substance.
1630 (d)(b) Any person who violates the provisions of
1631 subparagraphs (a)1.-7. commits a misdemeanor of the first
1632 degree, punishable as provided in s. 775.082 or s. 775.083;
1633 except that, upon a second or subsequent violation, the person
1634 commits a felony of the third degree, punishable as provided in
1635 s. 775.082, s. 775.083, or s. 775.084.
1636 (e)(c) Any person who violates the provisions of
1637 subparagraphs (a)8.-12. commits a felony of the third degree,
1638 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
1639 (f) A person or health care practitioner who violates the
1640 provisions of paragraph (b) or subparagraph (a)13. commits a
1641 felony of the third degree, punishable as provided in s.
1642 775.082, s. 775.083, or s. 775.084, if any controlled substance
1643 that is the subject of the offense is listed in Schedule II,
1644 Schedule III, or Schedule IV.
1645 (8)(a) Notwithstanding subsection (9), a prescribing
1646 practitioner may not:
1647 1. Knowingly assist a patient, other person, or the owner
1648 of an animal in obtaining a controlled substance through
1649 deceptive, untrue, or fraudulent representations in or related
1650 to the practice of the prescribing practitioner’s professional
1651 practice;
1652 2. Employ a trick or scheme in the practice of the
1653 prescribing practitioner’s professional practice to assist a
1654 patient, other person, or the owner of an animal in obtaining a
1655 controlled substance;
1656 3. Knowingly write a prescription for a controlled
1657 substance for a fictitious person; or
1658 4. Write a prescription for a controlled substance for a
1659 patient, other person, or an animal if the sole purpose of
1660 writing such prescription is to provide a monetary benefit to,
1661 or obtain a monetary benefit for, the prescribing practitioner;
1662 or.
1663 5. Write a prescription for a controlled substance for a
1664 patient, other person, or an animal and authorize or direct the
1665 adulteration of the dispensed form of the controlled substance
1666 for the purpose of ingestion by means of inhalation, injection,
1667 or any other means that is not medically necessary for the
1668 treatment of the patient.
1669 (b) If the prescribing practitioner wrote a prescription or
1670 multiple prescriptions for a controlled substance for the
1671 patient, other person, or animal for which there was no medical
1672 necessity, or which was in excess of what was medically
1673 necessary to treat the patient, other person, or animal, that
1674 fact does not give rise to any presumption that the prescribing
1675 practitioner violated subparagraph (a)1., but may be considered
1676 with other competent evidence in determining whether the
1677 prescribing practitioner knowingly assisted a patient, other
1678 person, or the owner of an animal to obtain a controlled
1679 substance in violation of subparagraph (a)1.
1680 (c) A person who violates paragraph (a) commits a felony of
1681 the third degree, punishable as provided in s. 775.082, s.
1682 775.083, or s. 775.084.
1683 (d) Notwithstanding paragraph (c), if a prescribing
1684 practitioner has violated paragraph (a) and received $1,000 or
1685 more in payment for writing one or more prescriptions or, in the
1686 case of a prescription written for a controlled substance
1687 described in s. 893.135, has written one or more prescriptions
1688 for a quantity of a controlled substance which, individually or
1689 in the aggregate, meets the threshold for the offense of
1690 trafficking in a controlled substance under s. 893.15, the
1691 violation is reclassified as a felony of the second degree and
1692 ranked in level 4 of the Criminal Punishment Code.
1693 Section 25. Present subsections (3) through (10) of section
1694 893.138, Florida Statutes, are redesignated as subsections (4)
1695 through (11), respectively, and a new subsection (3) is added to
1696 that section, to read:
1697 893.138 Local administrative action to abate drug-related,
1698 prostitution-related, or stolen-property-related public
1699 nuisances and criminal gang activity.—
1700 (3) Any pain-management clinic, as described in s. 458.3265
1701 or s. 459.0137, which has been used on more than two occasions
1702 within a 6-month period as the site of a violation of:
1703 (a) Section 784.011, s. 784.021, s. 784.03, or s. 784.045,
1704 relating to assault and battery;
1705 (b) Section 810.02, relating to burglary;
1706 (c) Section 812.014, relating to dealing in theft;
1707 (d) Section 812.131, relating to robbery by sudden
1708 snatching; or
1709 (e) Section 893.13, relating to the unlawful distribution
1710 of controlled substances,
1711
1712 may be declared to be a public nuisance, and such nuisance may
1713 be abated pursuant to the procedures provided in this section.
1714 Section 26. (1) DEFINITIONS.—As used in this section, the
1715 term:
1716 (a) “Interchange or substitution of an opioid analgesic
1717 drug” means the substitution of any opioid analgesic drug, brand
1718 or generic, for the opioid analgesic drug incorporating a
1719 tamper-resistance technology originally prescribed, irrespective
1720 of whether the substituted drug is rated as pharmaceutically and
1721 therapeutically equivalent by the United States Food and Drug
1722 Administration or the Board of Pharmacy or whether the opioid
1723 analgesic drug with tamper-resistance technology bears a
1724 labeling claim with respect to reduction of tampering, abuse, or
1725 abuse potential.
1726 (b) “Opioid analgesic drug” means a drug in the opioid
1727 analgesic drug class prescribed to treat moderate to severe pain
1728 or other conditions, whether in immediate release or extended
1729 release form and whether or not combined with other drug
1730 substances to form a single tablet or other dosage form.
1731 (c) “Opioid analgesic drug incorporating a tamper
1732 resistance technology” means an opioid analgesic drug listed as
1733 such by the Board of Pharmacy based on a submission of evidence
1734 by the drug manufacturer or distributor that the drug:
1735 1. Incorporates a tamper-resistance technology; and
1736 2. Has been approved by the United States Food and Drug
1737 Administration pursuant to an application that includes at least
1738 one study on human tampering or abuse potential or a laboratory
1739 study comparing the tamper- or abuse-resistance properties of
1740 the drug to one or more opioid analgesic drugs that:
1741 a. Have been approved by the United States Food and Drug
1742 Administration; and
1743 b. Serve as a positive control.
1744 (d) “Pharmacist” means any person licensed under chapter
1745 465, Florida Statutes, to practice the profession of pharmacy,
1746 including, but not limited to, a community pharmacist and a
1747 pharmacist in a hospital-based pharmacy, when filling
1748 prescriptions for inpatient or outpatient care.
1749 (2) LIST OF OPIOID ANALGESIC DRUGS INCORPORATING A TAMPER
1750 RESISTANCE TECHNOLOGY.—The Board of Pharmacy shall create a list
1751 of opioid analgesic drugs for which information has been
1752 submitted consistent with paragraph (1)(c). Inclusion of a drug
1753 on such list does not require that the drug bear a labeling
1754 claim with respect to reduction of tampering, abuse, or abuse
1755 potential at the time of listing. Such list must also include a
1756 determination by the Board of Pharmacy as to which listed opioid
1757 analgesic drugs incorporating tamper-resistance technologies
1758 provide substantially similar tamper-resistance properties,
1759 based solely on studies submitted by the drug manufacturer
1760 consistent with paragraph (1)(c).
1761 (3) PROHIBITION.—Notwithstanding s. 465.025, Florida
1762 Statutes, a pharmacist may not interchange or substitute an
1763 opioid analgesic drug, brand or generic, for an opioid analgesic
1764 drug incorporating a tamper-resistance technology which is
1765 listed pursuant to subsection (2) without:
1766 (a) Verifying that the opioid analgesic drug has been
1767 listed by the Board of Pharmacy under subsection (2) as
1768 providing tamper-resistance properties substantially similar to
1769 the prescribed opioid analgesic drug incorporating a tamper
1770 resistance technology; or
1771 (b) Obtaining written, signed consent from the prescribing
1772 physician for such interchange or substitution.
1773 Section 27. This act shall take effect October 1, 2011.
1774
1775 ================= T I T L E A M E N D M E N T ================
1776 And the title is amended as follows:
1777 Delete everything before the enacting clause
1778 and insert:
1779 A bill to be entitled
1780 An act relating to controlled substances; amending s.
1781 400.9905, F.S.; redefining the terms “clinic” and
1782 “portable equipment provider” within the Health Care
1783 Clinic Act; amending s. 456.013, F.S.; authorizing
1784 certain health care practitioners to complete a
1785 continuing education course relating to the
1786 prescription drug monitoring program; providing
1787 requirements for the course; requiring the Department
1788 of Health or a board that is authorized to exercise
1789 regulatory or rulemaking functions within the
1790 department to approve the course offered through a
1791 facility licensed under ch. 395, F.S., under certain
1792 circumstances; providing application of the course
1793 requirements; requiring a board or the Department of
1794 Health to adopt rules; amending s. 458.305, F.S.;
1795 defining the term “dispensing physician” as it relates
1796 to the practice of medicine in this state; prohibiting
1797 certain persons from using titles or displaying signs
1798 that would lead the public to believe that they engage
1799 in the dispensing of controlled substances;
1800 prohibiting certain persons, firms, or corporations
1801 from using a trade name, sign, letter, or
1802 advertisement that implies that the persons, firms, or
1803 corporations are licensed or registered to dispense
1804 prescription drugs; prohibiting certain persons,
1805 firms, or corporations from holding themselves out to
1806 the public as licensed or registered to dispense
1807 controlled substances; prohibiting certain persons
1808 from performing the functions of a dispensing
1809 physician; providing penalties; amending s. 458.3191,
1810 F.S.; revising the information in the physician survey
1811 that is submitted by persons who apply for licensure
1812 renewal as a physician under ch. 458 or ch. 459, F.S.;
1813 amending s. 458.3192, F.S.; requiring the Department
1814 of Health to provide nonidentifying information to the
1815 prescription drug monitoring program’s Implementation
1816 and Oversight Task Force regarding the number of
1817 physicians that are registered with the prescription
1818 drug monitoring program and that use the database from
1819 the program in their practice; amending s. 458.3265,
1820 F.S.; revising the list of entities that are not
1821 required to register as a pain-management clinic;
1822 deleting certain requirements for a physician to
1823 practice medicine in a pain-management clinic;
1824 requiring a physician who works in a pain-management
1825 clinic to document the reason a prescription for a
1826 certain dosage of a controlled substance is within the
1827 proper standard of care; creating a felony of the
1828 third-degree for any person to register or attempt to
1829 register a pain-management clinic through
1830 misrepresentation or fraud; amending s. 458.327, F.S.;
1831 providing additional penalties; amending s. 458.331,
1832 F.S.; providing additional grounds for disciplinary
1833 action by the Board of Medicine; amending s. 459.003,
1834 F.S.; defining the term “dispensing physician” as it
1835 relates to the practice of osteopathic medicine in
1836 this state; amending s. 459.013, F.S.; providing
1837 additional penalties; amending s. 459.0137, F.S.;
1838 requiring an osteopathic physician who works in a
1839 pain-management clinic to document the reason a
1840 prescription for a certain dosage of a controlled
1841 substance is within the proper standard of care;
1842 creating a felony of the third-degree for a licensee
1843 or other person who serves as the designated physician
1844 of a pain-management clinic to register a pain
1845 management clinic through misrepresentation or fraud;
1846 amending s. 459.015, F.S.; providing additional
1847 grounds for disciplinary action by the Board of
1848 Osteopathic Medicine; amending s. 465.015, F.S.;
1849 prohibiting certain persons from knowingly failing to
1850 report to the local county sheriff’s office and the
1851 Department of Law Enforcement the commission of a
1852 felony involving a person who acquires or obtains
1853 possession of a controlled substance by
1854 misrepresentation, fraud, forgery, deception, or
1855 subterfuge under certain conditions; providing
1856 penalties; providing requirements for reporting the
1857 commission of the felony that involves a person who
1858 acquires or obtains possession of a controlled
1859 substance by misrepresentation, fraud, forgery,
1860 deception, or subterfuge; providing that a pharmacist,
1861 pharmacy intern, or other person employed by or at a
1862 pharmacy is not subject to disciplinary action for
1863 reporting; amending s. 465.0276, F.S.; requiring a
1864 practitioner to register as a dispensing practitioner
1865 in order to dispense controlled substances; amending
1866 s. 766.101, F.S.; conforming a cross-reference;
1867 amending s. 810.02, F.S.; redefining the offense of
1868 burglary to include the theft of a controlled
1869 substance within a dwelling, structure, or conveyance;
1870 amending s. 812.014, F.S.; redefining the offense of
1871 theft to include the theft of a controlled substance;
1872 creating s. 893.021, F.S.; providing conditions in
1873 which a drug is considered adulterated; providing that
1874 a physician is not prevented from directing or
1875 prescribing a change to the recognized manufactured
1876 recommendations for use of any controlled substance in
1877 a patient under certain circumstances; requiring a
1878 prescribing physician to indicate any deviation of the
1879 recognized manufacturer’s recommended use of a
1880 controlled substance on the original prescription;
1881 requiring a pharmacist or physician to indicate such
1882 deviation on the label of the prescription upon
1883 dispensing; amending s. 893.04, F.S.; revising the
1884 required information that must appear on the face of a
1885 prescription or written record of a controlled
1886 substance before it is dispensed by a pharmacist;
1887 amending s. 893.055, F.S.; requiring that the
1888 prescription drug monitoring program comply with the
1889 minimum requirements of the National All Schedules
1890 Prescription Electronic Reporting Act; requiring the
1891 Department of Health to establish a method to allow
1892 corrections to the database of the prescription drug
1893 monitoring program; requiring the number of refills
1894 ordered and whether the drug was dispensed as a refill
1895 or a first-time request to be included in the database
1896 of the prescription drug monitoring program; revising
1897 the number of days in which a dispensed controlled
1898 substance must be reported to the department through
1899 the prescription drug monitoring program; revising the
1900 list of acts of dispensing or administering which are
1901 exempt from reporting; requiring a pharmacy,
1902 prescriber, practitioner, or dispenser to register
1903 with the department by submitting a registering
1904 document in order to have access to certain
1905 information in the prescription drug monitoring
1906 program’s database; requiring the department to
1907 approve the registering document before granting
1908 access to information in the prescription drug
1909 monitoring program’s database; requiring criminal
1910 background screening for those persons who have direct
1911 access to the prescription drug monitoring program’s
1912 database; authorizing the Attorney General to obtain
1913 confidential and exempt information for Medicaid fraud
1914 cases and Medicaid investigations; requiring certain
1915 documentation to be provided to the program manager in
1916 order to release confidential and exempt information
1917 from the prescription drug monitoring program’s
1918 database to a patient, legal guardian, or a designated
1919 health care surrogate; authorizing the Agency for
1920 Health Care Administration to obtain confidential and
1921 exempt information from the prescription drug
1922 monitoring program’s database for Medicaid fraud cases
1923 and Medicaid investigations involving controlled
1924 substances; deleting the provision that administrative
1925 costs of the prescription drug monitoring program are
1926 funded through federal grants and private sources;
1927 requiring the State Surgeon General to enter into
1928 reciprocal agreements for the sharing of information
1929 in the prescription drug monitoring program with other
1930 states that have a similar prescription drug
1931 monitoring program; requiring the State Surgeon
1932 General to annually review a reciprocal agreement to
1933 determine its compatibility; providing requirements
1934 for compatibility; prohibiting the sharing of certain
1935 information; amending s. 893.0551, F.S.; authorizing
1936 the Department of Health to disclose certain
1937 confidential and exempt information in the
1938 prescription drug monitoring program’s database under
1939 certain circumstances involving reciprocal agreements
1940 with other states; prohibiting the sharing of
1941 information from the prescription drug monitoring
1942 program’s database which is not for the purpose that
1943 is statutorily authorized or according to the State
1944 Surgeon General’s determination of compatibility;
1945 amending s. 893.07, F.S.; requiring that a person
1946 report to the Department of Law Enforcement and the
1947 local sheriff’s office the theft or loss of a
1948 controlled substance within a specified time;
1949 providing penalties; providing legislative intent;
1950 amending s. 893.13, F.S.; prohibiting a person from
1951 obtaining or attempting to obtain from a practitioner
1952 a controlled substance or a prescription for a
1953 controlled substance by misrepresentation, fraud,
1954 forgery, deception, subterfuge, or concealment of a
1955 material fact; prohibiting a health care provider from
1956 providing a controlled substance or a prescription for
1957 a controlled substance by misrepresentation, fraud,
1958 forgery, deception, subterfuge, or concealment of a
1959 material fact; prohibiting a person from adulterating
1960 a controlled substance for certain use without
1961 authorization by a prescribing physician; authorizing
1962 a law enforcement officer to seize as evidence the
1963 adulteration or off-label use of a prescribed
1964 controlled substance; providing that such adulterated
1965 or off-label use of the controlled substance may be
1966 returned to its owner only under certain conditions;
1967 providing penalties; prohibiting a prescribing
1968 practitioner from writing a prescription for a
1969 controlled substance and authorizing or directing the
1970 adulteration of the dispensed form of the controlled
1971 substance for the purpose of ingestion by means that
1972 is not medically necessary; amending s. 893.138, F.S.;
1973 providing circumstances in which a pain-management
1974 clinic may be declared a public nuisance; providing
1975 definitions; requiring the Board of Pharmacy to create
1976 a list of opioid analgesic drugs; providing
1977 requirements for the list of opioid analgesic drugs;
1978 prohibiting a pharmacist from interchanging or
1979 substituting an opioid analgesic drug, brand, or
1980 generic, for an opioid analgesic drug incorporating a
1981 tamper-resistance technology unless certain
1982 requirements are met; providing an effective date.