CS for CS for SB 818 First Engrossed
2011818e1
1 A bill to be entitled
2 An act relating to controlled substances; amending s.
3 400.9905, F.S.; redefining the terms “clinic” and
4 “portable equipment provider” within the Health Care
5 Clinic Act; amending s. 456.013, F.S.; authorizing
6 certain health care practitioners to complete a
7 continuing education course relating to the
8 prescription drug monitoring program; providing
9 requirements for the course; requiring the Department
10 of Health or a board that is authorized to exercise
11 regulatory or rulemaking functions within the
12 department to approve the course offered through a
13 facility licensed under ch. 395, F.S., under certain
14 circumstances; providing for application of the course
15 requirements; requiring a board or the Department of
16 Health to adopt rules; amending s. 458.305, F.S.;
17 defining the term “dispensing physician” as it relates
18 to the practice of medicine in this state; prohibiting
19 certain persons from using titles or displaying signs
20 that would lead the public to believe that they engage
21 in the dispensing of controlled substances;
22 prohibiting certain persons, firms, or corporations
23 from using a trade name, sign, letter, or
24 advertisement that implies that the persons, firms, or
25 corporations are licensed or registered to dispense
26 prescription drugs; prohibiting certain persons,
27 firms, or corporations from holding themselves out to
28 the public as licensed or registered to dispense
29 controlled substances; providing penalties; amending
30 s. 458.3191, F.S.; revising the information in the
31 physician survey that is submitted by persons who
32 apply for licensure renewal as a physician under ch.
33 458 or ch. 459, F.S.; amending s. 458.3192, F.S.;
34 requiring the Department of Health to provide
35 nonidentifying information to the prescription drug
36 monitoring program’s Implementation and Oversight Task
37 Force regarding the number of physicians that are
38 registered with the prescription drug monitoring
39 program and that use the database from the program in
40 their practice; amending s. 458.3265, F.S.; redefining
41 the term “pain-management clinic” and defining the
42 term “chronic nonmalignant pain”; revising the list of
43 entities that are not required to register as a pain
44 management clinic; authorizing the department to
45 revoke the certificate of registration of a pain
46 management clinic based upon a finding by a probable
47 cause panel of a board that the clinic does not meet
48 certain requirements; authorizing the department to
49 revoke a clinic’s certificate of registration and
50 prohibit all physicians associated with that clinic
51 from practicing at that clinic location based upon an
52 annual inspection and evaluation and upon a final
53 determination by the probable cause panel of the
54 appropriate board that any physician associated with
55 that pain-management clinic knew or should have known
56 of certain violations; prohibiting the department from
57 revoking or suspending a clinic’s registration if the
58 clinic appoints another designated physician;
59 prohibiting persons owning or operating a pain
60 management clinic that has a revoked registration from
61 applying to operate another pain-management clinic
62 within a specified number of years upon a finding by
63 the probable cause panel of the appropriate board, and
64 an opportunity to be heard, that the persons operating
65 such clinic knew or should have known of violations
66 causing such revocation; deleting certain requirements
67 for a physician to practice medicine in a pain
68 management clinic; requiring a physician, an advanced
69 registered nurse practitioner, or a physician
70 assistant to perform an appropriate medical
71 examination of a patient on the same day that the
72 physician dispenses or prescribes a controlled
73 substance to the patient at a pain-management clinic;
74 requiring a physician who works in a pain-management
75 clinic to document the reason a prescription for a
76 certain dosage of a controlled substance is within the
77 proper standard of care; creating a felony of the
78 third degree for any person to register or attempt to
79 register a pain-management clinic through
80 misrepresentation or fraud; amending s. 458.327, F.S.;
81 providing additional penalties; amending s. 458.331,
82 F.S.; providing additional grounds for disciplinary
83 action by the Board of Medicine; amending s. 459.003,
84 F.S.; defining the term “dispensing physician” as it
85 relates to the practice of osteopathic medicine in
86 this state; amending s. 459.0081, F.S.; revising the
87 information that must be furnished in a physician
88 survey to the Department of Health in order to renew a
89 license to practice osteopathic medicine; amending s.
90 459.0082, F.S.; requiring the department to provide
91 certain nonidentifying information to the
92 Implementation and Oversight Task Force of the
93 prescription drug monitoring program; amending s.
94 459.013, F.S.; providing additional penalties;
95 amending s. 459.0137, F.S.; redefining the term “pain
96 management clinic” and defining the term “chronic
97 nonmalignant pain”; providing an exemption from the
98 requirement that all privately owned pain-management
99 clinics, facilities, or offices that advertise in any
100 medium for any type of pain-management services, or
101 employ an osteopathic physician who is primarily
102 engaged in the treatment of pain by prescribing or
103 dispensing controlled substance medications, must
104 register with the Department of Health; authorizing
105 the department to revoke the certificate of
106 registration of a pain-management clinic based upon a
107 finding by a probable cause panel of a board that the
108 clinic does not meet certain requirements; authorizing
109 the department to revoke a clinic’s certificate of
110 registration and prohibit all physicians associated
111 with that clinic from practicing at that clinic
112 location based upon an annual inspection and
113 evaluation and upon a final determination by the
114 probable cause panel of the appropriate board that any
115 physician associated with that pain-management clinic
116 knew or should have known of certain violations;
117 prohibiting the department from revoking or suspending
118 a clinic’s registration if the clinic appoints another
119 designated physician; prohibiting persons owning or
120 operating a pain-management clinic that has a revoked
121 registration from applying to operate another pain
122 management clinic within a specified number of years
123 upon a finding by the probable cause panel of the
124 appropriate board, and an opportunity to be heard,
125 when the persons operating such clinic knew or should
126 have known of violations causing such revocation;
127 revising the responsibilities of an osteopathic
128 physician who provides professional services in a
129 pain-management clinic; requiring an osteopathic
130 physician, an advanced registered nurse practitioner,
131 or a physician assistant to perform an appropriate
132 medical examination of a patient on the same day that
133 the physician dispenses or prescribes a controlled
134 substance to the patient at a pain-management clinic;
135 requiring an osteopathic physician who works in a
136 pain-management clinic to document the reason a
137 prescription for a certain dosage of a controlled
138 substance is within the proper standard of care;
139 creating a felony of the third degree for a licensee
140 or other person who serves as the designated physician
141 of a pain-management clinic to register a pain
142 management clinic through misrepresentation or fraud;
143 amending s. 459.015, F.S.; providing additional
144 grounds for disciplinary action by the Board of
145 Osteopathic Medicine; amending s. 465.015, F.S.;
146 prohibiting a licensed pharmacist from knowingly
147 failing to report to the local county sheriff’s office
148 the commission of a felony involving a person who
149 acquires or obtains possession of a controlled
150 substance by misrepresentation, fraud, forgery,
151 deception, or subterfuge under certain conditions;
152 providing penalties; providing suggested criteria for
153 reporting the commission of a felony that involves a
154 person who acquires or obtains possession of a
155 controlled substance by misrepresentation, fraud,
156 forgery, deception, or subterfuge; providing that a
157 licensed pharmacist is not subject to disciplinary
158 action for reporting; amending s. 465.0276, F.S.;
159 requiring a practitioner to register as a dispensing
160 practitioner in order to dispense controlled
161 substances; amending s. 499.01, F.S.; authorizing
162 certain business entities to pay for prescription
163 drugs obtained by practitioners licensed under ch.
164 466, F.S.; amending s. 766.101, F.S.; conforming a
165 cross-reference; amending s. 810.02, F.S.; redefining
166 the offense of burglary to include the theft of a
167 controlled substance within a structure or conveyance;
168 amending s. 812.014, F.S.; redefining the offense of
169 theft to include the theft of a controlled substance;
170 creating s. 893.021, F.S.; providing conditions in
171 which a drug is considered adulterated; providing that
172 a physician is not prevented from directing or
173 prescribing a change to the recognized manufactured
174 recommendations for use of any controlled substance
175 for a patient under certain circumstances; requiring a
176 prescribing physician to indicate on the original
177 prescription any deviation of the recognized
178 manufacturer’s recommended use of a controlled
179 substance; requiring a pharmacist or physician to
180 indicate such deviation on the label of the
181 prescription upon dispensing; amending s. 893.04,
182 F.S.; revising the required information that must
183 appear on the face of a prescription or written record
184 of a controlled substance before it is dispensed by a
185 pharmacist; amending s. 893.055, F.S.; requiring that
186 the prescription drug monitoring program comply with
187 the minimum requirements established by the Department
188 of Health; requiring the Department of Health to
189 establish a method to allow corrections to the
190 database of the prescription drug monitoring program;
191 requiring the number of refills ordered and whether
192 the drug was dispensed as a refill or a first-time
193 request to be included in the database of the
194 prescription drug monitoring program; revising the
195 number of days in which a dispensed controlled
196 substance must be reported to the department through
197 the prescription drug monitoring program; revising the
198 list of acts of dispensing or administering which are
199 exempt from reporting; requiring a pharmacy,
200 prescriber, practitioner, or dispenser to register
201 with the department by submitting a registering
202 document in order to have access to certain
203 information in the prescription drug monitoring
204 program’s database; requiring the department to
205 approve the registering document before granting
206 access to information in the prescription drug
207 monitoring program’s database; requiring criminal
208 background screening for those persons who have direct
209 access to the prescription drug monitoring program’s
210 database; authorizing the Attorney General to obtain
211 confidential and exempt information for Medicaid fraud
212 cases and Medicaid investigations; requiring certain
213 documentation to be provided to the program manager in
214 order to release confidential and exempt information
215 from the prescription drug monitoring program’s
216 database to a patient, legal guardian, or a designated
217 health care surrogate; authorizing the Agency for
218 Health Care Administration to obtain confidential and
219 exempt information from the prescription drug
220 monitoring program’s database for Medicaid fraud cases
221 and Medicaid investigations involving controlled
222 substances; deleting a provision requiring that
223 administrative costs of the prescription drug
224 monitoring program be funded through federal grants
225 and private sources; requiring the State Surgeon
226 General to enter into reciprocal agreements for the
227 sharing of information in the prescription drug
228 monitoring program with other states that have a
229 similar prescription drug monitoring program;
230 requiring the State Surgeon General to annually review
231 a reciprocal agreement to determine its compatibility;
232 providing requirements for compatibility; prohibiting
233 the sharing of certain information; providing an
234 appropriation; amending s. 893.0551, F.S.; requiring
235 the Department of Health to disclose confidential and
236 exempt information pertaining to the prescription drug
237 monitoring program to the Attorney General and
238 designee when working on Medicaid fraud cases and
239 Medicaid investigations involving prescribed
240 controlled substances or when the Attorney General has
241 initiated a review of specific identifiers that
242 warrant a Medicaid investigation regarding prescribed
243 controlled substances; prohibiting the Attorney
244 General’s Medicaid investigators from direct access to
245 the prescription drug monitoring program’s database;
246 authorizing the Department of Health to disclose
247 certain confidential and exempt information in the
248 prescription drug monitoring program’s database under
249 certain circumstances involving reciprocal agreements
250 with other states; prohibiting the sharing of
251 information from the prescription drug monitoring
252 program’s database which is not for the purpose that
253 is statutorily authorized or according to the State
254 Surgeon General’s determination of compatibility;
255 amending s. 893.07, F.S.; requiring that a person
256 report to the local sheriff’s office the theft or
257 significant loss of a controlled substance within a
258 specified time; providing penalties; providing
259 legislative intent; amending s. 893.13, F.S.;
260 prohibiting a person from obtaining or attempting to
261 obtain from a practitioner a controlled substance or a
262 prescription for a controlled substance by
263 misrepresentation, fraud, forgery, deception,
264 subterfuge, or concealment of a material fact;
265 prohibiting a health care provider from providing a
266 controlled substance or a prescription for a
267 controlled substance by misrepresentation, fraud,
268 forgery, deception, subterfuge, or concealment of a
269 material fact; prohibiting a person from adulterating
270 a controlled substance for certain use without
271 authorization by a prescribing physician; authorizing
272 a law enforcement officer to seize as evidence the
273 adulteration or off-label use of a prescribed
274 controlled substance; providing that such adulterated
275 or off-label use of the controlled substance may be
276 returned to its owner only under certain conditions;
277 providing penalties; prohibiting a prescribing
278 practitioner from writing a prescription for a
279 controlled substance and authorizing or directing the
280 adulteration of the dispensed form of the controlled
281 substance for the purpose of ingestion by means not
282 medically necessary; amending s. 893.138, F.S.;
283 providing circumstances in which a pain-management
284 clinic may be declared a public nuisance; amending s.
285 465.025, F.S.; requiring the Board of Pharmacy to
286 create a list of opioid analgesic drugs; providing
287 requirements for the list of opioid analgesic drugs;
288 prohibiting a pharmacist from substituting an opioid
289 analgesic drug for an opioid analgesic drug that
290 incorporates a tamper-resistant technology; providing
291 an effective date.
292
293 Be It Enacted by the Legislature of the State of Florida:
294
295 Section 1. Subsections (4) and (7) of section 400.9905,
296 Florida Statutes, are amended to read:
297 400.9905 Definitions.—
298 (4) “Clinic” means an entity at which health care services
299 are provided to individuals and which tenders charges for
300 reimbursement or payment for such services, including a mobile
301 clinic and a portable equipment provider. For purposes of this
302 part, the term does not include and the licensure requirements
303 of this part do not apply to:
304 (a) Entities licensed or registered by the state under
305 chapter 395; or entities licensed or registered by the state and
306 providing only health care services within the scope of services
307 authorized under their respective licenses granted under ss.
308 383.30-383.335, chapter 390, chapter 394, chapter 397, this
309 chapter except part X, chapter 429, chapter 463, chapter 465,
310 chapter 466, chapter 478, part I of chapter 483, chapter 484, or
311 chapter 651; end-stage renal disease providers authorized under
312 42 C.F.R. part 405, subpart U; or providers certified under 42
313 C.F.R. part 485, subpart B or subpart H; or any entity that
314 provides neonatal or pediatric hospital-based health care
315 services or other health care services by licensed practitioners
316 solely within a hospital licensed under chapter 395.
317 (b) Entities that own, directly or indirectly, entities
318 licensed or registered by the state pursuant to chapter 395; or
319 entities that own, directly or indirectly, entities licensed or
320 registered by the state and providing only health care services
321 within the scope of services authorized pursuant to their
322 respective licenses granted under ss. 383.30-383.335, chapter
323 390, chapter 394, chapter 397, this chapter except part X,
324 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
325 part I of chapter 483, chapter 484, chapter 651; end-stage renal
326 disease providers authorized under 42 C.F.R. part 405, subpart
327 U; or providers certified under 42 C.F.R. part 485, subpart B or
328 subpart H; or any entity that provides neonatal or pediatric
329 hospital-based health care services by licensed practitioners
330 solely within a hospital licensed under chapter 395.
331 (c) Entities that are owned, directly or indirectly, by an
332 entity licensed or registered by the state pursuant to chapter
333 395; or entities that are owned, directly or indirectly, by an
334 entity licensed or registered by the state and providing only
335 health care services within the scope of services authorized
336 pursuant to their respective licenses granted under ss. 383.30
337 383.335, chapter 390, chapter 394, chapter 397, this chapter
338 except part X, chapter 429, chapter 463, chapter 465, chapter
339 466, chapter 478, part I of chapter 483, chapter 484, or chapter
340 651; end-stage renal disease providers authorized under 42
341 C.F.R. part 405, subpart U; or providers certified under 42
342 C.F.R. part 485, subpart B or subpart H; or any entity that
343 provides neonatal or pediatric hospital-based health care
344 services by licensed practitioners solely within a hospital
345 under chapter 395.
346 (d) Entities that are under common ownership, directly or
347 indirectly, with an entity licensed or registered by the state
348 pursuant to chapter 395; or entities that are under common
349 ownership, directly or indirectly, with an entity licensed or
350 registered by the state and providing only health care services
351 within the scope of services authorized pursuant to their
352 respective licenses granted under ss. 383.30-383.335, chapter
353 390, chapter 394, chapter 397, this chapter except part X,
354 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
355 part I of chapter 483, chapter 484, or chapter 651; end-stage
356 renal disease providers authorized under 42 C.F.R. part 405,
357 subpart U; or providers certified under 42 C.F.R. part 485,
358 subpart B or subpart H; or any entity that provides neonatal or
359 pediatric hospital-based health care services by licensed
360 practitioners solely within a hospital licensed under chapter
361 395.
362 (e) An entity that is exempt from federal taxation under 26
363 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan
364 under 26 U.S.C. s. 409 that has a board of trustees not less
365 than two-thirds of which are Florida-licensed health care
366 practitioners and provides only physical therapy services under
367 physician orders, any community college or university clinic,
368 and any entity owned or operated by the federal or state
369 government, including agencies, subdivisions, or municipalities
370 thereof.
371 (f) A sole proprietorship, group practice, partnership, or
372 corporation that provides health care services by physicians
373 covered by s. 627.419, that is directly supervised by one or
374 more of such physicians, and that is wholly owned by one or more
375 of those physicians or by a physician and the spouse, parent,
376 child, or sibling of that physician.
377 (g) A sole proprietorship, group practice, partnership, or
378 corporation that provides health care services by licensed
379 health care practitioners under chapter 457, chapter 458,
380 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
381 chapter 466, chapter 467, chapter 480, chapter 484, chapter 486,
382 chapter 490, chapter 491, or part I, part III, part X, part
383 XIII, or part XIV of chapter 468, or s. 464.012, which are
384 wholly owned by one or more licensed health care practitioners,
385 or the licensed health care practitioners set forth in this
386 paragraph and the spouse, parent, child, or sibling of a
387 licensed health care practitioner, so long as one of the owners
388 who is a licensed health care practitioner is supervising the
389 business activities and is legally responsible for the entity’s
390 compliance with all federal and state laws. However, a health
391 care practitioner may not supervise services beyond the scope of
392 the practitioner’s license, except that, for the purposes of
393 this part, a clinic owned by a licensee in s. 456.053(3)(b) that
394 provides only services authorized pursuant to s. 456.053(3)(b)
395 may be supervised by a licensee specified in s. 456.053(3)(b).
396 (h) Clinical facilities affiliated with an accredited
397 medical school at which training is provided for medical
398 students, residents, or fellows.
399 (i) Entities that provide only oncology or radiation
400 therapy services by physicians licensed under chapter 458 or
401 chapter 459 or entities that provide oncology or radiation
402 therapy services by physicians licensed under chapter 458 or
403 chapter 459 which are owned by a corporation whose shares are
404 publicly traded on a recognized stock exchange.
405 (j) Clinical facilities affiliated with a college of
406 chiropractic accredited by the Council on Chiropractic Education
407 at which training is provided for chiropractic students.
408 (k) Entities that provide licensed practitioners to staff
409 emergency departments or to deliver anesthesia services in
410 facilities licensed under chapter 395 and that derive at least
411 90 percent of their gross annual revenues from the provision of
412 such services. Entities claiming an exemption from licensure
413 under this paragraph must provide documentation demonstrating
414 compliance.
415 (l) Orthotic or prosthetic clinical facilities that are a
416 publicly traded corporation or that are wholly owned, directly
417 or indirectly, by a publicly traded corporation. As used in this
418 paragraph, a publicly traded corporation is a corporation that
419 issues securities traded on an exchange registered with the
420 United States Securities and Exchange Commission as a national
421 securities exchange.
422 (7) “Portable equipment provider” means an entity that
423 contracts with or employs persons to provide portable equipment
424 to multiple locations performing treatment or diagnostic testing
425 of individuals, that bills third-party payors for those
426 services, and that otherwise meets the definition of a clinic in
427 subsection (4).
428 Section 2. Subsection (7) of section 456.013, Florida
429 Statutes, is amended to read:
430 456.013 Department; general licensing provisions.—
431 (7)(a) The boards, or the department when there is no
432 board, shall require the completion of a 2-hour course relating
433 to prevention of medical errors as part of the licensure and
434 renewal process. The 2-hour course counts shall count towards
435 the total number of continuing education hours required for the
436 profession. The board or department shall approve the course
437 shall be approved by the board or department, as appropriate,
438 which must and shall include a study of root-cause analysis,
439 error reduction and prevention, and patient safety. In addition,
440 the course approved by the Board of Medicine and the Board of
441 Osteopathic Medicine must shall include information relating to
442 the five most misdiagnosed conditions during the previous
443 biennium, as determined by the board. If the course is being
444 offered by a facility licensed under pursuant to chapter 395 for
445 its employees, the board may approve up to 1 hour of the 2-hour
446 course to be specifically related to error reduction and
447 prevention methods used in that facility.
448 (b) As a condition of initial licensure and at each
449 subsequent license renewal, the boards, or the department if
450 there is no board, shall allow each practitioner licensed under
451 chapter 458, chapter 459, chapter 461, chapter 465, or chapter
452 466 whose lawful scope of practice authorizes the practitioner
453 to prescribe, administer, or dispense controlled substances to
454 complete a 1-hour continuing education course relating to the
455 prescription drug monitoring program. The course must include,
456 but need not be limited to:
457 1. The purpose of the prescription drug monitoring program.
458 2. The practitioners’ capabilities for improving the
459 standard of care for patients by using the prescription drug
460 monitoring program.
461 3. How the prescription drug monitoring program can help
462 practitioners detect doctor shopping.
463 4. The involvement of law enforcement personnel, the
464 Attorney General’s Medicaid Fraud Unit, and medical regulatory
465 investigators with the prescription drug monitoring program.
466 5. The procedures for registering for access to the
467 prescription drug monitoring program.
468
469 The course hours may be included in the total number of hours of
470 continuing education required by the profession and must be
471 approved by the board or by the department if there is no board.
472 The boards, or the department if there is no board, shall
473 approve the course offered through a facility licensed under
474 chapter 395 for its employees if the course is at least 3 hours
475 and covers the education requirements.
476 (c) The course requirements in paragraph (b) apply to each
477 licensee renewing his or her license on or after July 1, 2012,
478 and to each applicant approved for licensure on or after January
479 1, 2013.
480 (d) By October 1, 2011, the boards, or the department if
481 there is no board, shall adopt rules as necessary to administer
482 this subsection.
483 Section 3. Section 458.305, Florida Statutes, is amended to
484 read:
485 458.305 Definitions.—As used in this chapter:
486 (1) “Board” means the Board of Medicine.
487 (2) “Department” means the Department of Health.
488 (3) “Dispensing physician” means a physician who is
489 registered as a dispensing practitioner under s. 465.0276.
490 (4)(3) “Practice of medicine” means the diagnosis,
491 treatment, operation, or prescription for any human disease,
492 pain, injury, deformity, or other physical or mental condition.
493 (5)(4) “Physician” means a person who is licensed to
494 practice medicine in this state.
495 Section 4. Advertising of controlled substances by a
496 dispensing physician.—
497 (1)(a) Only a dispensing physician licensed under chapter
498 458 or chapter 459, Florida Statutes, may use the title
499 “dispensing physician” or “dispenser” or otherwise lead the
500 public to believe that he or she is engaged in the dispensing of
501 controlled substances.
502 (b) A person, other than an owner of a:
503 1. Pain-management clinic registered under chapter 458 or
504 chapter 459, Florida Statutes; or
505 2. Health clinic licensed under chapter 400, Florida
506 Statutes,
507
508 may not display any sign or take any other action that would
509 lead the public to believe that such person is engaged in the
510 business of dispensing a controlled substance. Any advertisement
511 that states “dispensing onsite” or “onsite pharmacy” violates
512 this paragraph. This paragraph does not preclude a person who is
513 not licensed as a medical practitioner from owning a pain
514 management clinic.
515 (c) A person, firm, or corporation, unless licensed under
516 chapter 465, Florida Statutes, may not use in a trade name,
517 sign, letter, or advertisement any term, including “drug,”
518 “pharmacy,” “onsite pharmacy,” “dispensing,” “dispensing
519 onsite,” “prescription drugs,” “Rx,” or “apothecary,” which
520 implies that the person, firm, or corporation is licensed or
521 registered to dispense prescription drugs in this state.
522 (2) A person who violates paragraph (1)(a) or paragraph
523 (1)(b) commits a misdemeanor of the first degree, punishable as
524 provided in s. 775.082 or s. 775.083, Florida Statutes. A person
525 who violates paragraph (1)(c) commits a felony of the third
526 degree, punishable as provided in s. 775.082, s. 775.083, or s.
527 775.084, Florida Statutes. In any warrant, information, or
528 indictment, it is not necessary to negate any exceptions, and
529 the burden of any exception is upon the defendant.
530 Section 5. Paragraph (a) of subsection (1) of section
531 458.3191, Florida Statutes, is amended to read:
532 458.3191 Physician survey.—
533 (1) Each person who applies for licensure renewal as a
534 physician under this chapter or chapter 459 must, in conjunction
535 with the renewal of such license under procedures adopted by the
536 Department of Health and in addition to any other information
537 that may be required from the applicant, furnish the following
538 to the Department of Health in a physician survey:
539 (a) Licensee information, including, but not limited to:
540 1. Frequency and geographic location of practice within the
541 state.
542 2. Practice setting.
543 3. Percentage of time spent in direct patient care.
544 4. Anticipated change to license or practice status.
545 5. Areas of specialty or certification.
546 6. Whether the department has ever approved or denied the
547 physician’s registration for access to a patient’s information
548 in the prescription drug monitoring program’s database.
549 7. Whether the physician uses the prescription drug
550 monitoring program with patients in his or her medical practice.
551 Section 6. Subsection (3) is added to section 458.3192,
552 Florida Statutes, to read:
553 458.3192 Analysis of survey results; report.—
554 (3) By November 1 each year, the Department of Health shall
555 provide nonidentifying information to the prescription drug
556 monitoring program’s Implementation and Oversight Task Force
557 regarding the number of physicians who are registered with the
558 prescription drug monitoring program and who also use the
559 database from the prescription drug monitoring program for their
560 patients in their medical practice.
561 Section 7. Paragraphs (a), (f), (g), (h), and (k) of
562 subsection (1) and paragraphs (a) and (c) of subsection (2) of
563 section 458.3265, Florida Statutes, are amended, and paragraphs
564 (f) and (g) are added to subsection (5) of that section, to
565 read:
566 458.3265 Pain-management clinics.—
567 (1) REGISTRATION.—
568 (a) “Pain-management clinic,” hereinafter referred to as
569 “clinic,” means a publicly or privately owned facility where in
570 any month a majority of patients are prescribed opioids,
571 benzodiazepines, barbiturates, or carisoprodol, for the
572 treatment of chronic nonmalignant pain. “Chronic nonmalignant
573 pain” means pain unrelated to cancer or rheumatoid arthritis
574 which persists beyond the usual course of disease or the injury
575 that is the cause of the pain or more than 90 days after
576 surgery. All privately owned pain-management clinics,
577 facilities, or offices, hereinafter referred to as “clinics,”
578 which advertise in any medium for any type of pain-management
579 services, or employ a physician who is primarily engaged in the
580 treatment of pain by prescribing or dispensing controlled
581 substance medications, must register with the department unless:
582 1. That clinic is licensed as a facility pursuant to
583 chapter 395;
584 2. The majority of the physicians who provide services in
585 the clinic primarily provide surgical services or interventional
586 pain procedures of the type routinely billed using surgical
587 codes;
588 3. The clinic is owned, directly or indirectly, by a
589 publicly held corporation whose shares are traded on a national
590 exchange or on the over-the-counter market and whose total
591 assets at the end of the corporation’s most recent fiscal
592 quarter exceeded $50 million;
593 4. The clinic is affiliated with an accredited medical
594 school at which training is provided for medical students,
595 residents, or fellows;
596 5. The clinic does not prescribe or dispense controlled
597 substances for the treatment of pain; or
598 6. The clinic is owned by a corporate entity exempt from
599 federal taxation under 26 U.S.C. s. 501(c)(3).
600 (f) If the department finds upon a hearing by the probable
601 cause panel of the appropriate board that a pain-management
602 clinic does not meet the requirement of paragraph (d) or is
603 owned, directly or indirectly, by a person meeting any criteria
604 listed in paragraph (e), the department shall revoke the
605 certificate of registration previously issued by the department.
606 As determined by rule, the department may grant an exemption to
607 denying a registration or revoking a previously issued
608 registration if more than 10 years have elapsed since
609 adjudication. As used in this subsection, the term “convicted”
610 includes an adjudication of guilt following a plea of guilty or
611 nolo contendere or the forfeiture of a bond when charged with a
612 crime.
613 (g) The department may revoke the clinic’s certificate of
614 registration and prohibit all physicians associated with that
615 pain-management clinic from practicing at that clinic location
616 based upon an annual inspection and evaluation of the factors
617 described in subsection (3) and upon a final determination by
618 the probable cause panel of the appropriate board that any
619 physician associated with that pain-management clinic knew or
620 should have known of any violations of the factors described in
621 subsection (3).
622 (h)1. If the registration of a pain-management clinic is
623 revoked or suspended, the designated physician of the pain
624 management clinic, the owner or lessor of the pain-management
625 clinic property, the manager, and the proprietor shall cease to
626 operate the facility as a pain-management clinic as of the
627 effective date of the suspension or revocation.
628 2. Notwithstanding subparagraph 1., the clinic’s
629 registration shall not be revoked or suspended if the clinic,
630 within 24 hours after notification of suspension or revocation,
631 appoints another designated physician who has a full, active,
632 and unencumbered license under this chapter or chapter 459 to
633 operate a pain-management clinic.
634 (k) If the clinic’s registration is revoked, any person
635 named in the registration documents of the pain-management
636 clinic, including persons owning or operating the pain
637 management clinic, may not, as an individual or as a part of a
638 group, apply to operate a pain-management clinic for 5 years
639 after the date the registration is revoked upon a finding by the
640 probable cause panel of the appropriate board, and an
641 opportunity to be heard, that the persons operating such clinic
642 knew or should have known of violations causing such revocation.
643 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
644 apply to any physician who provides professional services in a
645 pain-management clinic that is required to be registered in
646 subsection (1).
647 (a) A physician may not practice medicine in a pain
648 management clinic, as described in subsection (4), if:
649 1. the pain-management clinic is not registered with the
650 department as required by this section.; or
651 2. Effective July 1, 2012, the physician has not
652 successfully completed a pain-medicine fellowship that is
653 accredited by the Accreditation Council for Graduate Medical
654 Education or a pain-medicine residency that is accredited by the
655 Accreditation Council for Graduate Medical Education or, prior
656 to July 1, 2012, does not comply with rules adopted by the
657 board.
658
659 Any physician who qualifies to practice medicine in a pain
660 management clinic pursuant to rules adopted by the Board of
661 Medicine as of July 1, 2012, may continue to practice medicine
662 in a pain-management clinic as long as the physician continues
663 to meet the qualifications set forth in the board rules. A
664 physician who violates this paragraph is subject to disciplinary
665 action by his or her appropriate medical regulatory board.
666 (c) A physician, an advanced registered nurse practitioner,
667 or a physician assistant must perform an appropriate medical a
668 physical examination of a patient on the same day that the
669 physician he or she dispenses or prescribes a controlled
670 substance to a patient at a pain-management clinic. If the
671 physician prescribes or dispenses more than a 72-hour dose of
672 controlled substances for the treatment of chronic nonmalignant
673 pain, the physician must document in the patient’s record the
674 reason such dosage is within the standard of care. For the
675 purpose of this paragraph, the standard of care is set forth in
676 rule 64B8-9.013(3), Florida Administrative Code for prescribing
677 or dispensing that quantity.
678 (5) PENALTIES; ENFORCEMENT.—
679 (f) A licensee or other person who serves as the designated
680 physician of a pain-management clinic as defined in this section
681 or s. 459.0137 and registers a pain-management clinic through
682 misrepresentation or fraud or procures or attempts to procure
683 the registration of a pain-management clinic for any other
684 person by making or causing to be made any false or fraudulent
685 representation commits a felony of the third degree, punishable
686 as provided in s. 775.082, s. 775.083, or s. 775.084.
687 (g) Any person who registers a pain-management clinic
688 through misrepresentation or fraud or who procures or attempts
689 to procure the registration of a pain-management clinic for any
690 other person by making or causing to be made any false or
691 fraudulent representation, commits a felony of the third degree,
692 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
693 Section 8. Paragraphs (f) and (g) are added to subsection
694 (1), paragraphs (g) and (h) are added to subsection (2), and
695 subsection (3) is added to section 458.327, Florida Statutes, to
696 read:
697 458.327 Penalty for violations.—
698 (1) Each of the following acts constitutes a felony of the
699 third degree, punishable as provided in s. 775.082, s. 775.083,
700 or s. 775.084:
701 (f) Failing to perform a physical examination of a patient
702 by a physician or a licensed designee acting under the
703 physician’s supervision on the same day that the treating
704 physician dispenses or prescribes a controlled substance to the
705 patient at a pain-management clinic occurring three or more
706 times within a 6-month period, or failing to perform a physical
707 examination on three or more different patients on the same day
708 that the treating physician dispenses or prescribes a controlled
709 substance to each patient at a pain-management clinic within a
710 6-month period.
711 (g) Prescribing or dispensing in excess of a 72-hour dose
712 of controlled substances at a pain-management clinic for the
713 treatment of chronic nonmalignant pain of a patient occurring
714 three or more times within a 6-month period without documenting
715 in the patient’s record the reason that such dosage is within
716 the standard of care. For the purpose of this paragraph, the
717 standard of care is set forth in rule 64B8-9.013(3), Florida
718 Administrative Code.
719 (2) Each of the following acts constitutes a misdemeanor of
720 the first degree, punishable as provided in s. 775.082 or s.
721 775.083:
722 (g) Failing to perform a physical examination of a patient
723 on the same day that the treating physician dispenses or
724 prescribes a controlled substance to the patient at a pain
725 management clinic two times in a 6-month period, or failing to
726 perform a physical examination on two different patients on the
727 same day that the treating physician dispenses or prescribes a
728 controlled substance to each patient at a pain-management clinic
729 within a 6-month period.
730 (h) Prescribing or dispensing in excess of a 72-hour dose
731 of controlled substances at a pain-management clinic for the
732 treatment of chronic nonmalignant pain of a patient occurring
733 two times within a 6-month period without documenting in the
734 patient’s record the reason that such dosage is within the
735 standard of care. For the purpose of this paragraph, the
736 standard of care is set forth in rule 64B8-9.013(3), Florida
737 Administrative Code.
738 (3) Each of the following acts constitutes a misdemeanor of
739 the second degree, punishable as provided in s. 775.082 or s.
740 775.083:
741 (a) A first offense of failing to perform a physical
742 examination of a patient on the same day that the treating
743 physician dispenses or prescribes a controlled substance to the
744 patient at a pain-management clinic.
745 (b) A first offense of failing to document in a patient’s
746 record the reason that such dosage is within the standard of
747 care for prescribing or dispensing in excess of a 72-hour dose
748 of controlled substances at a pain-management clinic for the
749 treatment of chronic nonmalignant pain.
750 Section 9. Subsection (11) is added to section 458.331,
751 Florida Statutes, to read:
752 458.331 Grounds for disciplinary action; action by the
753 board and department.—
754 (11) Notwithstanding subsection (2), upon finding that a
755 physician has prescribed or dispensed, or caused to be
756 prescribed or dispensed, a controlled substance in a pain
757 management clinic in a manner that violates the standard of
758 practice as set forth in this chapter or rules adopted pursuant
759 to this chapter, the board shall, at a minimum, suspend the
760 physician’s license for at least 6 months and impose a fine of
761 at least $10,000 per count. Repeated violations shall result in
762 increased penalties.
763 Section 10. Present subsections (3), (4), and (5) of
764 section 459.003, Florida Statutes, are redesignated as
765 subsections (4), (5), and (6), respectively, and a new
766 subsection (3) is added to that section, to read:
767 459.003 Definitions.—As used in this chapter:
768 (3) “Dispensing physician” means an osteopathic physician
769 who is registered as a dispensing practitioner under s.
770 465.0276.
771 Section 11. Paragraph (a) of subsection (1) of section
772 459.0081, Florida Statutes, is amended to read:
773 459.0081 Physician survey.—
774 (1) Each person who applies for licensure renewal as a
775 physician under chapter 458 or this chapter must, in conjunction
776 with the renewal of such license under procedures adopted by the
777 Department of Health and in addition to any other information
778 that may be required from the applicant, furnish the following
779 to the Department of Health in a physician survey:
780 (a) Licensee information, including, but not limited to:
781 1. Frequency and geographic location of practice within the
782 state.
783 2. Practice setting.
784 3. Percentage of time spent in direct patient care.
785 4. Anticipated change to license or practice status.
786 5. Areas of specialty or certification.
787 6. Whether the department has ever approved or denied the
788 physician’s registration for access to a patient’s information
789 in the database of the prescription drug monitoring program.
790 7. Whether the physician uses the prescription drug
791 monitoring program with patients in his or her medical practice.
792 Section 12. Subsection (3) is added to section 459.0082,
793 Florida Statutes, to read:
794 459.0082 Analysis of survey results; report.—
795 (3) By November 1 of each year, the Department of Health
796 shall provide nonidentifying information to the Implementation
797 and Oversight Task Force of the prescription drug monitoring
798 program regarding the number of physicians who are registered
799 with the prescription drug monitoring program and who also use
800 the database from the prescription drug monitoring program for
801 their patients in their medical practice.
802 Section 13. Paragraphs (f) and (g) are added to subsection
803 (1), paragraphs (e) and (f) are added to subsection (2), and
804 paragraphs (d) and (e) are added to subsection (3) of section
805 459.013, Florida Statutes, to read:
806 459.013 Penalty for violations.—
807 (1) Each of the following acts constitutes a felony of the
808 third degree, punishable as provided in s. 775.082, s. 775.083,
809 or s. 775.084:
810 (f) Failing to perform a physical examination of a patient
811 on the same day that the osteopathic physician dispenses or
812 prescribes a controlled substance to the patient at a pain
813 management clinic occurring three or more times within a 6-month
814 period, or failing to perform a physical examination on three or
815 more different patients on the same day that the osteopathic
816 physician dispenses or prescribes a controlled substance to each
817 patient at a pain-management clinic within a 6-month period.
818 (g) Prescribing or dispensing in excess of a 72-hour dose
819 of controlled substances at a pain-management clinic for the
820 treatment of chronic nonmalignant pain of a patient occurring
821 three or more times within a 6-month period without documenting
822 in the patient’s record the reason that such dosage is within
823 the standard of care. For the purpose of this paragraph, the
824 standard of care is set forth in rule 64B15-14.005(3), Florida
825 Administrative Code.
826 (2) Each of the following acts constitutes a misdemeanor of
827 the first degree, punishable as provided in s. 775.082 or s.
828 775.083:
829 (e) Failing to perform a physical examination of a patient
830 on the same day that the osteopathic physician dispenses or
831 prescribes a controlled substance to the patient at a pain
832 management clinic occurring two times within a 6-month period,
833 or failing to perform a physical examination on two different
834 patients on the same day that the osteopathic physician
835 dispenses or prescribes a controlled substance to each patient
836 at a pain-management clinic within a 6-month period.
837 (f) Prescribing or dispensing in excess of a 72-hour dose
838 of controlled substances at a pain-management clinic for the
839 treatment of chronic nonmalignant pain of a patient occurring
840 two times within a 6-month period without documenting in the
841 patient’s record the reason that such dosage is within the
842 standard of care. For the purpose of this paragraph, the
843 standard of care is set forth in rule 64B15-14.005(3), Florida
844 Administrative Code.
845 (3) Each of the following constitutes a misdemeanor of the
846 second degree, punishable as provided in s. 775.082 or s.
847 775.083:
848 (d) A first offense of failing to perform a physical
849 examination of a patient on the same day that the osteopathic
850 physician dispenses or prescribes a controlled substance to the
851 patient at a pain-management clinic.
852 (e) A first offense of failing to document in a patient’s
853 record the reason that such dosage is within the standard of
854 care for prescribing or dispensing in excess of a 72-hour dose
855 of controlled substances at a pain-management clinic for the
856 treatment of chronic nonmalignant pain. For the purpose of this
857 paragraph, the standard of care is set forth in rule 64B15
858 14.005(3), Florida Administrative Code.
859 Section 14. Paragraphs (a), (f), (g), (h), and (k) of
860 subsection (1) and paragraphs (a) and (c) of subsection (2) of
861 section 459.0137, Florida Statutes, are amended, and paragraphs
862 (f) and (g) are added to subsection (5) of that section, to
863 read:
864 459.0137 Pain-management clinics.—
865 (1) REGISTRATION.—
866 (a) “Pain-management clinic,” hereinafter referred to as
867 “clinic,” means a publicly or privately owned facility where in
868 any month a majority of patients are prescribed opioids,
869 benzodiazepines, barbiturates, or carisoprodol for the treatment
870 of chronic nonmalignant pain. “Chronic nonmalignant pain” means
871 pain unrelated to cancer or rheumatoid arthritis which persists
872 beyond the usual course of a disease or the injury that is the
873 cause of the pain or more than 90 days after surgery. All
874 privately owned pain-management clinics, facilities, or offices,
875 hereinafter referred to as “clinics,” which advertise in any
876 medium for any type of pain-management services, or employ an
877 osteopathic physician who is primarily engaged in the treatment
878 of pain by prescribing or dispensing controlled substance
879 medications, must register with the department unless:
880 1. That clinic is licensed as a facility pursuant to
881 chapter 395;
882 2. The majority of the physicians who provide services in
883 the clinic primarily provide surgical services or interventional
884 pain procedures of the type routinely billed using surgical
885 codes;
886 3. The clinic is owned by a publicly held corporation whose
887 shares are traded on a national exchange or on the over-the
888 counter market and whose total assets at the end of the
889 corporation’s most recent fiscal quarter exceeded $50 million;
890 4. The clinic is affiliated with an accredited medical
891 school at which training is provided for medical students,
892 residents, or fellows;
893 5. The clinic does not prescribe or dispense controlled
894 substances for the treatment of pain; or
895 6. The clinic is owned by a corporate entity exempt from
896 federal taxation under 26 U.S.C. s. 501(c)(3).
897 (f) If the department finds upon a hearing by the probable
898 cause panel of the appropriate board that a pain-management
899 clinic does not meet the requirement of paragraph (d) or is
900 owned, directly or indirectly, by a person meeting any criteria
901 listed in paragraph (e), the department shall revoke the
902 certificate of registration previously issued by the department.
903 As determined by rule, the department may grant an exemption to
904 denying a registration or revoking a previously issued
905 registration if more than 10 years have elapsed since
906 adjudication. As used in this subsection, the term “convicted”
907 includes an adjudication of guilt following a plea of guilty or
908 nolo contendere or the forfeiture of a bond when charged with a
909 crime.
910 (g) The department may revoke the clinic’s certificate of
911 registration and prohibit all physicians associated with that
912 pain-management clinic from practicing at that clinic location
913 based upon an annual inspection and evaluation of the factors
914 described in subsection (3) and upon a final determination by
915 the probable cause panel of the appropriate board that any
916 physician associated with that pain-management clinic knew or
917 should have known of any violations of the factors described in
918 subsection (3).
919 (h)1. If the registration of a pain-management clinic is
920 revoked or suspended, the designated physician of the pain
921 management clinic, the owner or lessor of the pain-management
922 clinic property, the manager, and the proprietor shall cease to
923 operate the facility as a pain-management clinic as of the
924 effective date of the suspension or revocation.
925 2. Notwithstanding subparagraph 1., the clinic’s
926 registration shall not be revoked or suspended if the clinic,
927 within 24 hours after notification of suspension or revocation,
928 appoints another designated physician who has a full, active,
929 and unencumbered license under this chapter or chapter 458 to
930 operate a pain-management clinic.
931 (k) If the clinic’s registration is revoked, any person
932 named in the registration documents of the pain-management
933 clinic, including persons owning or operating the pain
934 management clinic, may not, as an individual or as a part of a
935 group, make application for a permit to operate a pain
936 management clinic for 5 years after the date the registration is
937 revoked upon a finding by the probable cause panel of the
938 appropriate board, and an opportunity to be heard, that the
939 persons operating such clinic knew or should have known of
940 violations causing such revocation.
941 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
942 apply to any osteopathic physician who provides professional
943 services in a pain-management clinic that is required to be
944 registered in subsection (1).
945 (a) An osteopathic physician may not practice medicine in a
946 pain-management clinic, as described in subsection (4), if:
947 1. The pain-management clinic is not registered with the
948 department as required by this section.; or
949 2. Effective July 1, 2012, the physician has not
950 successfully completed a pain-medicine fellowship that is
951 accredited by the Accreditation Council for Graduate Medical
952 Education or the American Osteopathic Association or a pain
953 medicine residency that is accredited by the Accreditation
954 Council for Graduate Medical Education or the American
955 Osteopathic Association or, prior to July 1, 2012, does not
956 comply with rules adopted by the board.
957
958 Any physician who qualifies to practice medicine in a pain
959 management clinic pursuant to rules adopted by the Board of
960 Osteopathic Medicine as of July 1, 2012, may continue to
961 practice medicine in a pain-management clinic as long as the
962 physician continues to meet the qualifications set forth in the
963 board rules. An osteopathic physician who violates this
964 paragraph is subject to disciplinary action by his or her
965 appropriate medical regulatory board.
966 (c) An osteopathic physician, an advanced registered nurse
967 practitioner, or a physician assistant must perform an
968 appropriate medical a physical examination of a patient on the
969 same day that the physician he or she dispenses or prescribes a
970 controlled substance to a patient at a pain-management clinic.
971 If the osteopathic physician prescribes or dispenses more than a
972 72-hour dose of controlled substances for the treatment of
973 chronic nonmalignant pain, the osteopathic physician must
974 document in the patient’s record the reason for which
975 prescribing or dispensing a dosage in excess of a 72-hour dose
976 of controlled substances for the treatment of chronic
977 nonmalignant pain is within the standard of care for prescribing
978 or dispensing that quantity.
979 (5) PENALTIES; ENFORCEMENT.—
980 (f) A licensee or other person who serves as the designated
981 physician of a pain-management clinic as defined in s. 458.3265
982 or s. 459.0137 and registers a pain-management clinic through
983 intentional misrepresentation or fraud or procures or attempts
984 to procure the registration of a pain-management clinic for any
985 other person by making or causing to be made any false or
986 fraudulent representation commits a felony of the third degree,
987 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
988 (g) Any person who registers a pain-management clinic
989 through misrepresentation or fraud or who procures or attempts
990 to procure the registration of a pain-management clinic for any
991 other person by making or causing to be made any false or
992 fraudulent representation, commits a felony of the third degree,
993 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
994 Section 15. Subsection (11) is added to section 459.015,
995 Florida Statutes, to read:
996 459.015 Grounds for disciplinary action; action by the
997 board and department.—
998 (11) Notwithstanding subsection (2), upon finding that an
999 osteopathic physician has prescribed or dispensed, or caused to
1000 be prescribed or dispensed, a controlled substance in a pain
1001 management clinic in a manner that violates the standard of
1002 practice as set forth in this chapter or rules adopted pursuant
1003 to this chapter, the board shall, at a minimum, suspend the
1004 osteopathic physician’s license for at least 6 months and impose
1005 a fine of at least $10,000 per count. Repeated violations shall
1006 result in increased penalties.
1007 Section 16. Present subsections (3) and (4) of section
1008 465.015, Florida Statutes, are renumbered as subsections (4) and
1009 (5), respectively, and a new subsection (3) is added to that
1010 section, to read:
1011 465.015 Violations and penalties.—
1012 (3)(a) A licensed pharmacist may not knowingly fail to
1013 timely report to the local county sheriff’s office the name of
1014 any person who obtains or attempts to obtain a substance
1015 controlled by s. 893.03 which the licensed pharmacist knows or
1016 reasonably should have known was obtained or attempted to be
1017 obtained from the pharmacy through any fraudulent method or
1018 representation. A licensed pharmacist who fails to make such a
1019 report within 24 hours after learning of the fraud or attempted
1020 fraud commits a misdemeanor of the first degree, punishable as
1021 provided in s. 775.082 or s. 775.083.
1022 (b) A sufficient report of the fraudulent obtaining of or
1023 attempt to obtain a controlled substance under this subsection
1024 may contain, at a minimum, a copy of the prescription used or
1025 presented and a narrative, including all information available
1026 to the pharmacy regarding:
1027 1. The transaction, such as the name and telephone number
1028 of the prescribing physician;
1029 2. The name, description, and any personal identification
1030 information pertaining to the person presenting the
1031 prescription; and
1032 3. All other material information, such as photographic or
1033 video surveillance of the transaction.
1034
1035 A licensed pharmacist is not subject to disciplinary action for
1036 reporting under this subsection.
1037 Section 17. Subsection (6) is added to section 465.0276,
1038 Florida Statutes, to read:
1039 465.0276 Dispensing practitioner.—
1040 (6) In order to dispense a controlled substance listed in
1041 Schedule II, Schedule III, or Schedule IV in s. 893.03, a
1042 practitioner authorized by law to prescribe a controlled
1043 substance shall register with the Board of Pharmacy as a
1044 dispensing practitioner who dispenses controlled substances and
1045 pay a fee not to exceed $100. The department shall adopt rules
1046 establishing procedures for renewal of the registration every 4
1047 years.
1048 Section 18. Paragraph (t) of subsection (2) of section
1049 499.01, Florida Statutes, is amended to read:
1050 499.01 Permits.—
1051 (2) The following permits are established:
1052 (t) Health care clinic establishment permit.—Effective
1053 January 1, 2009, a health care clinic establishment permit is
1054 required for the purchase of a prescription drug by a place of
1055 business at one general physical location that provides health
1056 care or veterinary services, which is owned and operated by a
1057 business entity that has been issued a federal employer tax
1058 identification number. For the purpose of this paragraph, the
1059 term “qualifying practitioner” means a licensed health care
1060 practitioner defined in s. 456.001, or a veterinarian licensed
1061 under chapter 474, who is authorized under the appropriate
1062 practice act to prescribe and administer a prescription drug.
1063 1. An establishment must provide, as part of the
1064 application required under s. 499.012, designation of a
1065 qualifying practitioner who will be responsible for complying
1066 with all legal and regulatory requirements related to the
1067 purchase, recordkeeping, storage, and handling of the
1068 prescription drugs. In addition, the designated qualifying
1069 practitioner shall be the practitioner whose name, establishment
1070 address, and license number is used on all distribution
1071 documents for prescription drugs purchased or returned by the
1072 health care clinic establishment. Upon initial appointment of a
1073 qualifying practitioner, the qualifying practitioner and the
1074 health care clinic establishment shall notify the department on
1075 a form furnished by the department within 10 days after such
1076 employment. In addition, the qualifying practitioner and health
1077 care clinic establishment shall notify the department within 10
1078 days after any subsequent change.
1079 2. The health care clinic establishment must employ a
1080 qualifying practitioner at each establishment.
1081 3. In addition to the remedies and penalties provided in
1082 this part, a violation of this chapter by the health care clinic
1083 establishment or qualifying practitioner constitutes grounds for
1084 discipline of the qualifying practitioner by the appropriate
1085 regulatory board.
1086 4. The purchase of prescription drugs by the health care
1087 clinic establishment is prohibited during any period of time
1088 when the establishment does not comply with this paragraph.
1089 5. A health care clinic establishment permit is not a
1090 pharmacy permit or otherwise subject to chapter 465. A health
1091 care clinic establishment that meets the criteria of a modified
1092 Class II institutional pharmacy under s. 465.019 is not eligible
1093 to be permitted under this paragraph.
1094 6. This paragraph does not apply to the purchase of a
1095 prescription drug by a licensed practitioner under his or her
1096 license. A professional corporation or limited liability company
1097 composed of dentists and operating as authorized in s. 466.0285
1098 may pay for prescription drugs obtained by a practitioner
1099 licensed under chapter 466, and the licensed practitioner is
1100 deemed the purchaser and owner of the prescription drugs.
1101 Section 19. Paragraph (a) of subsection (1) of section
1102 766.101, Florida Statutes, is amended to read:
1103 766.101 Medical review committee, immunity from liability.—
1104 (1) As used in this section:
1105 (a) The term “medical review committee” or “committee”
1106 means:
1107 1.a. A committee of a hospital or ambulatory surgical
1108 center licensed under chapter 395 or a health maintenance
1109 organization certificated under part I of chapter 641,
1110 b. A committee of a physician-hospital organization, a
1111 provider-sponsored organization, or an integrated delivery
1112 system,
1113 c. A committee of a state or local professional society of
1114 health care providers,
1115 d. A committee of a medical staff of a licensed hospital or
1116 nursing home, provided the medical staff operates pursuant to
1117 written bylaws that have been approved by the governing board of
1118 the hospital or nursing home,
1119 e. A committee of the Department of Corrections or the
1120 Correctional Medical Authority as created under s. 945.602, or
1121 employees, agents, or consultants of either the department or
1122 the authority or both,
1123 f. A committee of a professional service corporation formed
1124 under chapter 621 or a corporation organized under chapter 607
1125 or chapter 617, which is formed and operated for the practice of
1126 medicine as defined in s. 458.305(4) s. 458.305(3), and which
1127 has at least 25 health care providers who routinely provide
1128 health care services directly to patients,
1129 g. A committee of the Department of Children and Family
1130 Services which includes employees, agents, or consultants to the
1131 department as deemed necessary to provide peer review,
1132 utilization review, and mortality review of treatment services
1133 provided pursuant to chapters 394, 397, and 916,
1134 h. A committee of a mental health treatment facility
1135 licensed under chapter 394 or a community mental health center
1136 as defined in s. 394.907, provided the quality assurance program
1137 operates pursuant to the guidelines which have been approved by
1138 the governing board of the agency,
1139 i. A committee of a substance abuse treatment and education
1140 prevention program licensed under chapter 397 provided the
1141 quality assurance program operates pursuant to the guidelines
1142 which have been approved by the governing board of the agency,
1143 j. A peer review or utilization review committee organized
1144 under chapter 440,
1145 k. A committee of the Department of Health, a county health
1146 department, healthy start coalition, or certified rural health
1147 network, when reviewing quality of care, or employees of these
1148 entities when reviewing mortality records, or
1149 l. A continuous quality improvement committee of a pharmacy
1150 licensed pursuant to chapter 465,
1151
1152 which committee is formed to evaluate and improve the quality of
1153 health care rendered by providers of health service, to
1154 determine that health services rendered were professionally
1155 indicated or were performed in compliance with the applicable
1156 standard of care, or that the cost of health care rendered was
1157 considered reasonable by the providers of professional health
1158 services in the area; or
1159 2. A committee of an insurer, self-insurer, or joint
1160 underwriting association of medical malpractice insurance, or
1161 other persons conducting review under s. 766.106.
1162 Section 20. Subsection (3) of section 810.02, Florida
1163 Statutes, is amended to read:
1164 810.02 Burglary.—
1165 (3) Burglary is a felony of the second degree, punishable
1166 as provided in s. 775.082, s. 775.083, or s. 775.084, if, in the
1167 course of committing the offense, the offender does not make an
1168 assault or battery and is not and does not become armed with a
1169 dangerous weapon or explosive, and the offender enters or
1170 remains in a:
1171 (a) Dwelling, and there is another person in the dwelling
1172 at the time the offender enters or remains;
1173 (b) Dwelling, and there is not another person in the
1174 dwelling at the time the offender enters or remains;
1175 (c) Structure, and there is another person in the structure
1176 at the time the offender enters or remains;
1177 (d) Conveyance, and there is another person in the
1178 conveyance at the time the offender enters or remains; or
1179 (e) Authorized emergency vehicle, as defined in s. 316.003;
1180 or.
1181 (f) Structure or conveyance when the offense intended to be
1182 committed is theft of a substance controlled by s. 893.03.
1183 Notwithstanding any contrary provisions of law, separate
1184 judgments and sentences for burglary with the intent to commit
1185 theft of a controlled substance under this paragraph and for any
1186 applicable offense for possession of a controlled substance
1187 under s. 893.13, or an offense for trafficking in a controlled
1188 substance under s. 893.135, may be imposed if all such offenses
1189 involve the same amount or amounts of a controlled substance.
1190
1191 However, if the burglary is committed within a county that is
1192 subject to a state of emergency declared by the Governor under
1193 chapter 252 after the declaration of emergency is made and the
1194 perpetration of the burglary is facilitated by conditions
1195 arising from the emergency, the burglary is a felony of the
1196 first degree, punishable as provided in s. 775.082, s. 775.083,
1197 or s. 775.084. As used in this subsection, the term “conditions
1198 arising from the emergency” means civil unrest, power outages,
1199 curfews, voluntary or mandatory evacuations, or a reduction in
1200 the presence of or response time for first responders or
1201 homeland security personnel. A person arrested for committing a
1202 burglary within a county that is subject to such a state of
1203 emergency may not be released until the person appears before a
1204 committing magistrate at a first appearance hearing. For
1205 purposes of sentencing under chapter 921, a felony offense that
1206 is reclassified under this subsection is ranked one level above
1207 the ranking under s. 921.0022 or s. 921.0023 of the offense
1208 committed.
1209 Section 21. Paragraph (c) of subsection (2) of section
1210 812.014, Florida Statutes, is amended to read:
1211 812.014 Theft.—
1212 (2)
1213 (c) It is grand theft of the third degree and a felony of
1214 the third degree, punishable as provided in s. 775.082, s.
1215 775.083, or s. 775.084, if the property stolen is:
1216 1. Valued at $300 or more, but less than $5,000.
1217 2. Valued at $5,000 or more, but less than $10,000.
1218 3. Valued at $10,000 or more, but less than $20,000.
1219 4. A will, codicil, or other testamentary instrument.
1220 5. A firearm.
1221 6. A motor vehicle, except as provided in paragraph (a).
1222 7. Any commercially farmed animal, including any animal of
1223 the equine, bovine, or swine class, or other grazing animal, and
1224 including aquaculture species raised at a certified aquaculture
1225 facility. If the property stolen is aquaculture species raised
1226 at a certified aquaculture facility, then a $10,000 fine shall
1227 be imposed.
1228 8. Any fire extinguisher.
1229 9. Any amount of citrus fruit consisting of 2,000 or more
1230 individual pieces of fruit.
1231 10. Taken from a designated construction site identified by
1232 the posting of a sign as provided for in s. 810.09(2)(d).
1233 11. Any stop sign.
1234 12. Anhydrous ammonia.
1235 13. Any amount of a substance controlled by s. 893.03.
1236 Notwithstanding any contrary provisions of law, separate
1237 judgments and sentences for theft of a controlled substance
1238 under this subparagraph, and for any applicable offense for
1239 possession of a controlled substance under s. 893.13, or an
1240 offense for trafficking in a controlled substance under s.
1241 893.135 may be imposed if all such offenses involve the same
1242 amount or amounts of controlled substance.
1243
1244 However, if the property is stolen within a county that is
1245 subject to a state of emergency declared by the Governor under
1246 chapter 252, the property is stolen after the declaration of
1247 emergency is made, and the perpetration of the theft is
1248 facilitated by conditions arising from the emergency, the
1249 offender commits a felony of the second degree, punishable as
1250 provided in s. 775.082, s. 775.083, or s. 775.084, if the
1251 property is valued at $5,000 or more, but less than $10,000, as
1252 provided under subparagraph 2., or if the property is valued at
1253 $10,000 or more, but less than $20,000, as provided under
1254 subparagraph 3. As used in this paragraph, the term “conditions
1255 arising from the emergency” means civil unrest, power outages,
1256 curfews, voluntary or mandatory evacuations, or a reduction in
1257 the presence of or the response time for first responders or
1258 homeland security personnel. For purposes of sentencing under
1259 chapter 921, a felony offense that is reclassified under this
1260 paragraph is ranked one level above the ranking under s.
1261 921.0022 or s. 921.0023 of the offense committed.
1262 Section 22. Section 893.021, Florida Statutes, is created
1263 to read:
1264 893.021 Adulterated drug.—
1265 (1) As used in this chapter, a drug is adulterated if it is
1266 a controlled substance that:
1267 (a) Has been produced, prepared, packed, and marketed for
1268 oral consumption by the manufacturer; and
1269 (b) Has had any change to its integrity or composition for
1270 use by means of inhalation, injection, or any other form of
1271 ingestion not in accordance with the manufacturer’s recommended
1272 use, and such mode of use has not been previously directed and
1273 approved by the prescribing physician.
1274 (2) A physician is not prevented from directing or
1275 prescribing a change to the recognized manufactured
1276 recommendations for use in a patient who presents a medical need
1277 for such a requirement change of any controlled substance. The
1278 prescribing physician shall clearly indicate any deviation of
1279 the recognized manufacturer’s recommended use of a controlled
1280 substance on the original prescription, and the licensed
1281 pharmacist shall clearly indicate such deviation on the label of
1282 the prescription upon dispensing the controlled substance.
1283 Section 23. Paragraphs (c), (d), and (e) of subsection (1)
1284 of section 893.04, Florida Statutes, are amended to read:
1285 893.04 Pharmacist and practitioner.—
1286 (1) A pharmacist, in good faith and in the course of
1287 professional practice only, may dispense controlled substances
1288 upon a written or oral prescription of a practitioner, under the
1289 following conditions:
1290 (c) The following information must There shall appear on
1291 the face of the prescription or written record of a thereof for
1292 the controlled substance the following information:
1293 1. The full name and address of the person for whom, or the
1294 owner of the animal for which, the controlled substance is
1295 dispensed.
1296 2. The full name and address of the prescribing
1297 practitioner and the practitioner’s federal controlled substance
1298 registry number shall be printed thereon.
1299 3. If the prescription is for an animal, the species of
1300 animal for which the controlled substance is prescribed.
1301 4. The name of the controlled substance prescribed and the
1302 strength, quantity, and directions for use thereof. The
1303 directions for use must specify the authorization by the
1304 physician, any instructions requiring the adulteration of the
1305 dispensed form of the medication, and the medical necessity for
1306 the adulteration in accordance with s. 893.021.
1307 5. The number of the prescription, as recorded in the
1308 prescription files of the pharmacy in which it is filled.
1309 6. The initials of the pharmacist filling the prescription
1310 and the date filled.
1311 (d) The prescription must shall be retained on file by the
1312 proprietor of the pharmacy in which it is filled for a period of
1313 2 years.
1314 (e) A label bearing the following information must be
1315 affixed to the original container in which a controlled
1316 substance is delivered as upon a prescription or authorized
1317 refill thereof, as hereinafter provided, there shall be a label
1318 bearing the following information:
1319 1. The name and address of the pharmacy from which such
1320 controlled substance was dispensed.
1321 2. The date on which the prescription for such controlled
1322 substance was filled.
1323 3. The number of such prescription, as recorded in the
1324 prescription files of the pharmacy in which it is filled.
1325 4. The name of the prescribing practitioner.
1326 5. The name of the patient for whom, or of the owner and
1327 species of the animal for which, the controlled substance is
1328 prescribed.
1329 6. The directions for the use of the controlled substance
1330 prescribed in the prescription.
1331 7. A clear, concise warning that it is a crime to transfer
1332 the controlled substance to any person other than the patient
1333 for whom prescribed.
1334 Section 24. Section 893.055, Florida Statutes, is amended
1335 to read:
1336 893.055 Prescription drug monitoring program.—
1337 (1) As used in this section, the term:
1338 (a) “Patient advisory report” or “advisory report” means
1339 information provided by the department in writing, or as
1340 determined by the department, to a prescriber, dispenser,
1341 pharmacy, or patient concerning the dispensing of controlled
1342 substances. All advisory reports are for informational purposes
1343 only and impose no obligations of any nature or any legal duty
1344 on a prescriber, dispenser, pharmacy, or patient. The patient
1345 advisory report shall be provided in accordance with s.
1346 893.13(7)(a)8. The advisory reports issued by the department are
1347 not subject to discovery or introduction into evidence in any
1348 civil or administrative action against a prescriber, dispenser,
1349 pharmacy, or patient arising out of matters that are the subject
1350 of the report; and a person who participates in preparing,
1351 reviewing, issuing, or any other activity related to an advisory
1352 report may not be permitted or required to testify in any such
1353 civil action as to any findings, recommendations, evaluations,
1354 opinions, or other actions taken in connection with preparing,
1355 reviewing, or issuing such a report.
1356 (b) “Controlled substance” means a controlled substance
1357 listed in Schedule II, Schedule III, or Schedule IV in s.
1358 893.03.
1359 (c) “Dispenser” means a pharmacy, dispensing pharmacist, or
1360 dispensing health care practitioner.
1361 (d) “Health care practitioner” or “practitioner” means any
1362 practitioner who is subject to licensure or regulation by the
1363 department under chapter 458, chapter 459, chapter 461, chapter
1364 462, chapter 464, chapter 465, or chapter 466.
1365 (e) “Health care regulatory board” means any board for a
1366 practitioner or health care practitioner who is licensed or
1367 regulated by the department.
1368 (f) “Pharmacy” means any pharmacy that is subject to
1369 licensure or regulation by the department under chapter 465 and
1370 that dispenses or delivers a controlled substance to an
1371 individual or address in this state.
1372 (g) “Prescriber” means a prescribing physician, prescribing
1373 practitioner, or other prescribing health care practitioner.
1374 (h) “Active investigation” means an investigation that is
1375 being conducted with a reasonable, good faith belief that it
1376 could lead to the filing of administrative, civil, or criminal
1377 proceedings, or that is ongoing and continuing and for which
1378 there is a reasonable, good faith anticipation of securing an
1379 arrest or prosecution in the foreseeable future.
1380 (i) “Law enforcement agency” means the Department of Law
1381 Enforcement, a Florida sheriff’s department, a Florida police
1382 department, or a law enforcement agency of the Federal
1383 Government which enforces the laws of this state or the United
1384 States relating to controlled substances, and which its agents
1385 and officers are empowered by law to conduct criminal
1386 investigations and make arrests.
1387 (j) “Program manager” means an employee of or a person
1388 contracted by the Department of Health who is designated to
1389 ensure the integrity of the prescription drug monitoring program
1390 in accordance with the requirements established in paragraphs
1391 (2)(a) and (b).
1392 (2)(a) By December 1, 2010, the department shall design and
1393 establish a comprehensive electronic database system that has
1394 controlled substance prescriptions provided to it and that
1395 provides prescription information to a patient’s health care
1396 practitioner and pharmacist who inform the department that they
1397 wish the patient advisory report provided to them. Otherwise,
1398 the patient advisory report will not be sent to the
1399 practitioner, pharmacy, or pharmacist. The system shall be
1400 designed to provide information regarding dispensed
1401 prescriptions of controlled substances and shall not infringe
1402 upon the legitimate prescribing or dispensing of a controlled
1403 substance by a prescriber or dispenser acting in good faith and
1404 in the course of professional practice. The system shall be
1405 consistent with standards of the American Society for Automation
1406 in Pharmacy (ASAP). The electronic system shall also comply with
1407 the Health Insurance Portability and Accountability Act (HIPAA)
1408 as it pertains to protected health information (PHI), electronic
1409 protected health information (EPHI), minimum requirements as
1410 established by the department for authentication of a
1411 practitioner who requests information in the prescription drug
1412 monitoring program database and certification of the purpose for
1413 which information is requested, and all other relevant state and
1414 federal privacy and security laws and regulations. The
1415 department shall establish policies and procedures as
1416 appropriate regarding the reporting, accessing the database,
1417 evaluation, management, development, implementation, operation,
1418 storage, and security of information within the system. The
1419 reporting of prescribed controlled substances shall include a
1420 dispensing transaction with a dispenser pursuant to chapter 465
1421 or through a dispensing transaction to an individual or address
1422 in this state with a pharmacy that is not located in this state
1423 but that is otherwise subject to the jurisdiction of this state
1424 as to that dispensing transaction. The reporting of patient
1425 advisory reports refers only to reports to patients, pharmacies,
1426 and practitioners. Separate reports that contain patient
1427 prescription history information and that are not patient
1428 advisory reports are provided to persons and entities as
1429 authorized in paragraphs (7)(b) and (c) and s. 893.0551.
1430 (b) The department, when the direct support organization
1431 receives at least $20,000 in nonstate moneys or the state
1432 receives at least $20,000 in federal grants for the prescription
1433 drug monitoring program, and in consultation with the Office of
1434 Drug Control, shall adopt rules as necessary concerning the
1435 reporting, accessing the database, evaluation, management,
1436 development, implementation, operation, security, and storage of
1437 information within the system, including rules for when patient
1438 advisory reports are provided to pharmacies and prescribers. The
1439 patient advisory report shall be provided in accordance with s.
1440 893.13(7)(a)8. The department shall work with the professional
1441 health care licensure boards, such as the Board of Medicine, the
1442 Board of Osteopathic Medicine, and the Board of Pharmacy; other
1443 appropriate organizations, such as the Florida Pharmacy
1444 Association, the Office of Drug Control, the Florida Medical
1445 Association, the Florida Retail Federation, and the Florida
1446 Osteopathic Medical Association, including those relating to
1447 pain management; and the Attorney General, the Department of Law
1448 Enforcement, and the Agency for Health Care Administration to
1449 develop rules appropriate for the prescription drug monitoring
1450 program.
1451 (c) All dispensers and prescribers subject to these
1452 reporting requirements shall be notified by the department of
1453 the implementation date for such reporting requirements.
1454 (d) The program manager shall work with professional health
1455 care licensure boards and the stakeholders listed in paragraph
1456 (b) to develop rules appropriate for identifying indicators of
1457 controlled substance abuse.
1458 (e) The department shall establish a method to allow
1459 corrections to the database when notified by a health care
1460 practitioner or pharmacist.
1461 (3) The pharmacy dispensing the controlled substance and
1462 each prescriber who directly dispenses a controlled substance
1463 shall submit to the electronic system, by a procedure and in a
1464 format established by the department and consistent with an
1465 ASAP-approved format, the following information for inclusion in
1466 the database:
1467 (a) The name of the prescribing practitioner, the
1468 practitioner’s federal Drug Enforcement Administration
1469 registration number, the practitioner’s National Provider
1470 Identification (NPI) or other appropriate identifier, and the
1471 date of the prescription.
1472 (b) The date the prescription was filled and the method of
1473 payment, such as cash by an individual, insurance coverage
1474 through a third party, or Medicaid payment. This paragraph does
1475 not authorize the department to include individual credit card
1476 numbers or other account numbers in the database.
1477 (c) The full name, address, and date of birth of the person
1478 for whom the prescription was written.
1479 (d) The name, national drug code, quantity, and strength of
1480 the controlled substance dispensed.
1481 (e) The full name, federal Drug Enforcement Administration
1482 registration number, and address of the pharmacy or other
1483 location from which the controlled substance was dispensed. If
1484 the controlled substance was dispensed by a practitioner other
1485 than a pharmacist, the practitioner’s full name, federal Drug
1486 Enforcement Administration registration number, and address.
1487 (f) The name of the pharmacy or practitioner, other than a
1488 pharmacist, dispensing the controlled substance and the
1489 practitioner’s National Provider Identification (NPI).
1490 (g) Other appropriate identifying information as determined
1491 by department rule.
1492 (h) The number of refills ordered and whether the drug was
1493 dispensed as a refill of a prescription or was a first-time
1494 request.
1495 (4) Each time a controlled substance is dispensed to an
1496 individual, the controlled substance shall be reported to the
1497 department through the system as soon thereafter as possible,
1498 but not more than 7 15 days after the date the controlled
1499 substance is dispensed unless an extension is approved by the
1500 department for cause as determined by rule. A dispenser must
1501 meet the reporting requirements of this section by providing the
1502 required information concerning each controlled substance that
1503 it dispensed in a department-approved, secure methodology and
1504 format. Such approved formats may include, but are not limited
1505 to, submission via the Internet, on a disc, or by use of regular
1506 mail.
1507 (5) When the following acts of dispensing or administering
1508 occur, the following are exempt from reporting under this
1509 section for that specific act of dispensing or administration:
1510 (a) A health care practitioner when administering a
1511 controlled substance directly to a patient if the amount of the
1512 controlled substance is adequate to treat the patient during
1513 that particular treatment session.
1514 (b) A pharmacist or health care practitioner when
1515 administering a controlled substance to a patient or resident
1516 receiving care as a patient at a hospital, nursing home,
1517 ambulatory surgical center, hospice, or intermediate care
1518 facility for the developmentally disabled which is licensed in
1519 this state.
1520 (c) A practitioner when administering or dispensing a
1521 controlled substance in the health care system of the Department
1522 of Corrections.
1523 (c)(d) A practitioner when administering a controlled
1524 substance in the emergency room of a licensed hospital.
1525 (d)(e) A health care practitioner when administering or
1526 dispensing a controlled substance to a person under the age of
1527 16 if the amount of the controlled substance is adequate to
1528 treat the patient during that particular treatment session.
1529 (e)(f) A pharmacist or a dispensing practitioner when
1530 dispensing a one-time, 48-hour 72-hour emergency resupply of a
1531 controlled substance to a patient.
1532 (6) The department may establish when to suspend and when
1533 to resume reporting information during a state-declared or
1534 nationally declared disaster.
1535 (7)(a) A practitioner or pharmacist who dispenses a
1536 controlled substance must submit the information required by
1537 this section in an electronic or other method in an ASAP format
1538 approved by rule of the department unless otherwise provided in
1539 this section. The cost to the dispenser in submitting the
1540 information required by this section may not be material or
1541 extraordinary. Costs not considered to be material or
1542 extraordinary include, but are not limited to, regular postage,
1543 electronic media, regular electronic mail, and facsimile
1544 charges.
1545 (b)1. In order for a pharmacy, prescriber, practitioner, or
1546 dispenser to shall have access to information in the
1547 prescription drug monitoring program’s database which relates to
1548 a patient of that pharmacy, prescriber, practitioner, or
1549 dispenser, the pharmacy, prescriber, practitioner, or dispenser
1550 shall register with the department by submitting a registering
1551 document provided by the department. The document and validation
1552 of that document shall be determined by the department. Before a
1553 pharmacy, prescriber, practitioner, or dispenser is granted
1554 access to information in the database from the prescription drug
1555 monitoring program, the department shall approve the submitted
1556 document. Upon approval, the department shall grant the
1557 registrant access to the appropriate information in the
1558 prescription drug monitoring program’s database in a manner
1559 established by the department as needed for the purpose of
1560 reviewing the patient’s controlled substance prescription
1561 history.
1562 2. Other access to the program’s database shall be limited
1563 to the program’s manager and to the designated program and
1564 support staff, who may act only at the direction of the program
1565 manager or, in the absence of the program manager, as
1566 authorized. Access by the program manager or such designated
1567 staff is for prescription drug program management only or for
1568 management of the program’s database and its system in support
1569 of the requirements of this section and in furtherance of the
1570 prescription drug monitoring program. Confidential and exempt
1571 information in the database shall be released only as provided
1572 in paragraph (c) and s. 893.0551. The program manager,
1573 designated program and support staff who act at the direction of
1574 or in the absence of the program manager, and any individual who
1575 has similar access regarding the management of the database from
1576 the prescription drug monitoring program shall submit
1577 fingerprints to the department for background screening. The
1578 department shall follow the procedure established by the
1579 Department of Law Enforcement to request a statewide criminal
1580 history record check and to request that the Department of Law
1581 Enforcement forward the fingerprints to the Federal Bureau of
1582 Investigation for a national criminal history record check.
1583 (c) The following entities may shall not have be allowed
1584 direct access to information in the prescription drug monitoring
1585 program database but may request from the program manager and,
1586 when authorized by the program manager, the program manager’s
1587 program and support staff, information that is confidential and
1588 exempt under s. 893.0551. Prior to release, the request shall be
1589 verified as authentic and authorized with the requesting
1590 organization by the program manager, the program manager’s
1591 program and support staff, or as determined in rules by the
1592 department as being authentic and as having been authorized by
1593 the requesting entity:
1594 1. The department or its relevant health care regulatory
1595 boards responsible for the licensure, regulation, or discipline
1596 of practitioners, pharmacists, or other persons who are
1597 authorized to prescribe, administer, or dispense controlled
1598 substances and who are involved in a specific controlled
1599 substance investigation involving a designated person for one or
1600 more prescribed controlled substances.
1601 2. The Attorney General for Medicaid fraud cases or
1602 Medicaid investigations involving prescribed controlled
1603 substances.
1604 3. A law enforcement agency during active investigations
1605 regarding potential criminal activity, fraud, or theft regarding
1606 prescribed controlled substances.
1607 4. A patient or the legal guardian or designated health
1608 care surrogate of an incapacitated patient as described in s.
1609 893.0551 who, for the purpose of verifying the accuracy of the
1610 database information, submits a written and notarized request
1611 that includes the patient’s full name, address, and date of
1612 birth, and includes the same information if the legal guardian
1613 or health care surrogate submits the request. The patient’s
1614 phone number, current address, and a copy of a government-issued
1615 photo identification must be provided in person to the program
1616 manager along with the notarized request. The request shall be
1617 validated by the department to verify the identity of the
1618 patient and the legal guardian or health care surrogate, if the
1619 patient’s legal guardian or health care surrogate is the
1620 requestor. Such verification is also required for any request to
1621 change a patient’s prescription history or other information
1622 related to his or her information in the electronic database.
1623 5. The Agency for Health Care Administration for Medicaid
1624 fraud cases or Medicaid investigations involving prescribed
1625 controlled substances.
1626
1627 Information in the database for the electronic prescription drug
1628 monitoring system is not discoverable or admissible in any civil
1629 or administrative action, except in an investigation and
1630 disciplinary proceeding by the department or the appropriate
1631 regulatory board.
1632 (d) The following entities may shall not have be allowed
1633 direct access to information in the prescription drug monitoring
1634 program database but may request from the program manager and,
1635 when authorized by the program manager, the program manager’s
1636 program and support staff, information that contains no
1637 identifying information of any patient, physician, health care
1638 practitioner, prescriber, or dispenser and that is not
1639 confidential and exempt:
1640 1. Department staff for the purpose of calculating
1641 performance measures pursuant to subsection (8).
1642 2. The Program Implementation and Oversight Task Force for
1643 its reporting to the Governor, the President of the Senate, and
1644 the Speaker of the House of Representatives regarding the
1645 prescription drug monitoring program. This subparagraph expires
1646 July 1, 2012.
1647 (e) All transmissions of data required by this section must
1648 comply with relevant state and federal privacy and security laws
1649 and regulations. However, any authorized agency or person under
1650 s. 893.0551 receiving such information as allowed by s. 893.0551
1651 may maintain the information received for up to 24 months before
1652 purging it from his or her records or maintain it for longer
1653 than 24 months if the information is pertinent to ongoing health
1654 care or an active law enforcement investigation or prosecution.
1655 (f) The program manager, upon determining a pattern
1656 consistent with the rules established under paragraph (2)(d) and
1657 having cause to believe a violation of s. 893.13(7)(a)8.,
1658 (8)(a), or (8)(b) has occurred, may provide relevant information
1659 to the applicable law enforcement agency.
1660 (8) To assist in fulfilling program responsibilities,
1661 performance measures shall be reported annually to the Governor,
1662 the President of the Senate, and the Speaker of the House of
1663 Representatives by the department each December 1, beginning in
1664 2011. Data that does not contain patient, physician, health care
1665 practitioner, prescriber, or dispenser identifying information
1666 may be requested during the year by department employees so that
1667 the department may undertake public health care and safety
1668 initiatives that take advantage of observed trends. Performance
1669 measures may include, but are not limited to, efforts to achieve
1670 the following outcomes:
1671 (a) Reduction of the rate of inappropriate use of
1672 prescription drugs through department education and safety
1673 efforts.
1674 (b) Reduction of the quantity of pharmaceutical controlled
1675 substances obtained by individuals attempting to engage in fraud
1676 and deceit.
1677 (c) Increased coordination among partners participating in
1678 the prescription drug monitoring program.
1679 (d) Involvement of stakeholders in achieving improved
1680 patient health care and safety and reduction of prescription
1681 drug abuse and prescription drug diversion.
1682 (9) Any person who willfully and knowingly fails to report
1683 the dispensing of a controlled substance as required by this
1684 section commits a misdemeanor of the first degree, punishable as
1685 provided in s. 775.082 or s. 775.083.
1686 (10) All costs incurred by the department in administering
1687 the prescription drug monitoring program shall be funded through
1688 federal grants or private funding applied for or received by the
1689 state. The department may not commit funds for the monitoring
1690 program without ensuring funding is available. The prescription
1691 drug monitoring program and the implementation thereof are
1692 contingent upon receipt of the nonstate funding. The department
1693 and state government shall cooperate with the direct-support
1694 organization established pursuant to subsection (11) in seeking
1695 federal grant funds, other nonstate grant funds, gifts,
1696 donations, or other private moneys for the department so long as
1697 the costs of doing so are not considered material. Nonmaterial
1698 costs for this purpose include, but are not limited to, the
1699 costs of mailing and personnel assigned to research or apply for
1700 a grant. Notwithstanding the exemptions to competitive
1701 solicitation requirements under s. 287.057(3)(f), the department
1702 shall comply with the competitive-solicitation requirements
1703 under s. 287.057 for the procurement of any goods or services
1704 required by this section.
1705 (11) The Office of Drug Control, in coordination with the
1706 department, may establish a direct-support organization that has
1707 a board consisting of at least five members to provide
1708 assistance, funding, and promotional support for the activities
1709 authorized for the prescription drug monitoring program.
1710 (a) As used in this subsection, the term “direct-support
1711 organization” means an organization that is:
1712 1. A Florida corporation not for profit incorporated under
1713 chapter 617, exempted from filing fees, and approved by the
1714 Department of State.
1715 2. Organized and operated to conduct programs and
1716 activities; raise funds; request and receive grants, gifts, and
1717 bequests of money; acquire, receive, hold, and invest, in its
1718 own name, securities, funds, objects of value, or other
1719 property, either real or personal; and make expenditures or
1720 provide funding to or for the direct or indirect benefit of the
1721 department in the furtherance of the prescription drug
1722 monitoring program.
1723 (b) The direct-support organization is not considered a
1724 lobbying firm within the meaning of s. 11.045.
1725 (c) The director of the Office of Drug Control shall
1726 appoint a board of directors for the direct-support
1727 organization. The director may designate employees of the Office
1728 of Drug Control, state employees other than state employees from
1729 the department, and any other nonstate employees as appropriate,
1730 to serve on the board. Members of the board shall serve at the
1731 pleasure of the director of the Office of Drug Control. The
1732 director shall provide guidance to members of the board to
1733 ensure that moneys received by the direct-support organization
1734 are not received from inappropriate sources. Inappropriate
1735 sources include, but are not limited to, donors, grantors,
1736 persons, or organizations that may monetarily or substantively
1737 benefit from the purchase of goods or services by the department
1738 in furtherance of the prescription drug monitoring program.
1739 (d) The direct-support organization shall operate under
1740 written contract with the Office of Drug Control. The contract
1741 must, at a minimum, provide for:
1742 1. Approval of the articles of incorporation and bylaws of
1743 the direct-support organization by the Office of Drug Control.
1744 2. Submission of an annual budget for the approval of the
1745 Office of Drug Control.
1746 3. Certification by the Office of Drug Control in
1747 consultation with the department that the direct-support
1748 organization is complying with the terms of the contract in a
1749 manner consistent with and in furtherance of the goals and
1750 purposes of the prescription drug monitoring program and in the
1751 best interests of the state. Such certification must be made
1752 annually and reported in the official minutes of a meeting of
1753 the direct-support organization.
1754 4. The reversion, without penalty, to the Office of Drug
1755 Control, or to the state if the Office of Drug Control ceases to
1756 exist, of all moneys and property held in trust by the direct
1757 support organization for the benefit of the prescription drug
1758 monitoring program if the direct-support organization ceases to
1759 exist or if the contract is terminated.
1760 5. The fiscal year of the direct-support organization,
1761 which must begin July 1 of each year and end June 30 of the
1762 following year.
1763 6. The disclosure of the material provisions of the
1764 contract to donors of gifts, contributions, or bequests,
1765 including such disclosure on all promotional and fundraising
1766 publications, and an explanation to such donors of the
1767 distinction between the Office of Drug Control and the direct
1768 support organization.
1769 7. The direct-support organization’s collecting, expending,
1770 and providing of funds to the department for the development,
1771 implementation, and operation of the prescription drug
1772 monitoring program as described in this section and s. 2,
1773 chapter 2009-198, Laws of Florida, as long as the task force is
1774 authorized. The direct-support organization may collect and
1775 expend funds to be used for the functions of the direct-support
1776 organization’s board of directors, as necessary and approved by
1777 the director of the Office of Drug Control. In addition, the
1778 direct-support organization may collect and provide funding to
1779 the department in furtherance of the prescription drug
1780 monitoring program by:
1781 a. Establishing and administering the prescription drug
1782 monitoring program’s electronic database, including hardware and
1783 software.
1784 b. Conducting studies on the efficiency and effectiveness
1785 of the program to include feasibility studies as described in
1786 subsection (13).
1787 c. Providing funds for future enhancements of the program
1788 within the intent of this section.
1789 d. Providing user training of the prescription drug
1790 monitoring program, including distribution of materials to
1791 promote public awareness and education and conducting workshops
1792 or other meetings, for health care practitioners, pharmacists,
1793 and others as appropriate.
1794 e. Providing funds for travel expenses.
1795 f. Providing funds for administrative costs, including
1796 personnel, audits, facilities, and equipment.
1797 g. Fulfilling all other requirements necessary to implement
1798 and operate the program as outlined in this section.
1799 (e) The activities of the direct-support organization must
1800 be consistent with the goals and mission of the Office of Drug
1801 Control, as determined by the office in consultation with the
1802 department, and in the best interests of the state. The direct
1803 support organization must obtain a written approval from the
1804 director of the Office of Drug Control for any activities in
1805 support of the prescription drug monitoring program before
1806 undertaking those activities.
1807 (f) The Office of Drug Control, in consultation with the
1808 department, may permit, without charge, appropriate use of
1809 administrative services, property, and facilities of the Office
1810 of Drug Control and the department by the direct-support
1811 organization, subject to this section. The use must be directly
1812 in keeping with the approved purposes of the direct-support
1813 organization and may not be made at times or places that would
1814 unreasonably interfere with opportunities for the public to use
1815 such facilities for established purposes. Any moneys received
1816 from rentals of facilities and properties managed by the Office
1817 of Drug Control and the department may be held by the Office of
1818 Drug Control or in a separate depository account in the name of
1819 the direct-support organization and subject to the provisions of
1820 the letter of agreement with the Office of Drug Control. The
1821 letter of agreement must provide that any funds held in the
1822 separate depository account in the name of the direct-support
1823 organization must revert to the Office of Drug Control if the
1824 direct-support organization is no longer approved by the Office
1825 of Drug Control to operate in the best interests of the state.
1826 (g) The Office of Drug Control, in consultation with the
1827 department, may adopt rules under s. 120.54 to govern the use of
1828 administrative services, property, or facilities of the
1829 department or office by the direct-support organization.
1830 (h) The Office of Drug Control may not permit the use of
1831 any administrative services, property, or facilities of the
1832 state by a direct-support organization if that organization does
1833 not provide equal membership and employment opportunities to all
1834 persons regardless of race, color, religion, gender, age, or
1835 national origin.
1836 (i) The direct-support organization shall provide for an
1837 independent annual financial audit in accordance with s.
1838 215.981. Copies of the audit shall be provided to the Office of
1839 Drug Control and the Office of Policy and Budget in the
1840 Executive Office of the Governor.
1841 (j) The direct-support organization may not exercise any
1842 power under s. 617.0302(12) or (16).
1843 (12) A prescriber or dispenser may have access to the
1844 information under this section which relates to a patient of
1845 that prescriber or dispenser as needed for the purpose of
1846 reviewing the patient’s controlled drug prescription history. A
1847 prescriber or dispenser acting in good faith is immune from any
1848 civil, criminal, or administrative liability that might
1849 otherwise be incurred or imposed for receiving or using
1850 information from the prescription drug monitoring program. This
1851 subsection does not create a private cause of action, and a
1852 person may not recover damages against a prescriber or dispenser
1853 authorized to access information under this subsection for
1854 accessing or failing to access such information.
1855 (13) To the extent that funding is provided for such
1856 purpose through federal or private grants or gifts and other
1857 types of available moneys, the department, in collaboration with
1858 the Office of Drug Control, shall study the feasibility of
1859 enhancing the prescription drug monitoring program for the
1860 purposes of public health initiatives and statistical reporting
1861 that respects the privacy of the patient, the prescriber, and
1862 the dispenser. Such a study shall be conducted in order to
1863 further improve the quality of health care services and safety
1864 by improving the prescribing and dispensing practices for
1865 prescription drugs, taking advantage of advances in technology,
1866 reducing duplicative prescriptions and the overprescribing of
1867 prescription drugs, and reducing drug abuse. The requirements of
1868 the National All Schedules Prescription Electronic Reporting
1869 (NASPER) Act are authorized in order to apply for federal NASPER
1870 funding. In addition, the direct-support organization shall
1871 provide funding for the department, in collaboration with the
1872 Office of Drug Control, to conduct training for health care
1873 practitioners and other appropriate persons in using the
1874 monitoring program to support the program enhancements.
1875 (14) A pharmacist, pharmacy, or dispensing health care
1876 practitioner or his or her agent, before releasing a controlled
1877 substance to any person not known to such dispenser, shall
1878 require the person purchasing, receiving, or otherwise acquiring
1879 the controlled substance to present valid photographic
1880 identification or other verification of his or her identity to
1881 the dispenser. If the person does not have proper
1882 identification, the dispenser may verify the validity of the
1883 prescription and the identity of the patient with the prescriber
1884 or his or her authorized agent. Verification of health plan
1885 eligibility through a real-time inquiry or adjudication system
1886 will be considered to be proper identification. This subsection
1887 does not apply in an institutional setting or to a long-term
1888 care facility, including, but not limited to, an assisted living
1889 facility or a hospital to which patients are admitted. As used
1890 in this subsection, the term “proper identification” means an
1891 identification that is issued by a state or the Federal
1892 Government containing the person’s photograph, printed name, and
1893 signature or a document considered acceptable under 8 C.F.R. s.
1894 274a.2(b)(1)(v)(A) and (B).
1895 (15) The Agency for Health Care Administration shall
1896 continue the promotion of electronic prescribing by health care
1897 practitioners, health care facilities, and pharmacies under s.
1898 408.0611.
1899 (16) By October 1, 2010, the department shall adopt rules
1900 pursuant to ss. 120.536(1) and 120.54 to administer the
1901 provisions of this section, which shall include as necessary the
1902 reporting, accessing, evaluation, management, development,
1903 implementation, operation, and storage of information within the
1904 monitoring program’s system.
1905 (17) After the prescription drug monitoring program’s
1906 database has been operational for 12 months, the State Surgeon
1907 General shall enter into reciprocal agreements for the sharing
1908 of prescription drug monitoring information with any other state
1909 that has a compatible prescription drug monitoring program. If
1910 the State Surgeon General evaluates the prescription drug
1911 monitoring program of another state as authorized in this
1912 subsection, priority shall be given to a state that is
1913 contiguous with the borders of this state.
1914 (a) In determining compatibility, the State Surgeon General
1915 shall consider:
1916 1. The essential purposes of the program and the success of
1917 the program in fulfilling those purposes.
1918 2. The safeguards for privacy of patient records and the
1919 success of the program in protecting patient privacy.
1920 3. The persons authorized to view the data collected by the
1921 program. Comparable organizations and professions for
1922 practitioners in other states, law enforcement agencies, the
1923 Attorney General’s Medicaid Fraud Unit, medical regulatory
1924 boards, and, as needed, management staff who have similar duties
1925 as management staff who work with the prescription drug
1926 monitoring program as authorized in s. 893.0551 are authorized
1927 access upon approval by the State Surgeon General.
1928 4. The schedules of the controlled substances that are
1929 monitored.
1930 5. The data required to be submitted for each prescription.
1931 6. Any implementing criteria deemed essential for a
1932 thorough comparison.
1933 (b) The State Surgeon General shall annually review any
1934 agreement to determine its continued compatibility with the
1935 prescription drug monitoring program in this state.
1936 (c) Any agreement between the State Surgeon General and
1937 another state shall prohibit the sharing of information
1938 concerning a resident of this state or a practitioner,
1939 pharmacist, or other prescriber for any purpose that is not
1940 otherwise authorized by this section or s. 893.0551.
1941 Section 25. The sum of $1.75 million is appropriated from
1942 the General Revenue Fund to the Department of Health for the
1943 purpose of paying salaries and other administrative expenses
1944 necessary to carry out the implementation of the prescription
1945 drug monitoring program.
1946 Section 26. Paragraph (a) of subsection (3) of section
1947 893.0551, Florida Statutes, is amended, present subsections (4),
1948 (5), (6), and (7) of that section are redesignated as
1949 subsections (5), (6), (7), and (8), respectively, and a new
1950 subsection (4) is added to that section, to read:
1951 893.0551 Public records exemption for the prescription drug
1952 monitoring program.—
1953 (3) The department shall disclose such confidential and
1954 exempt information to the following entities after using a
1955 verification process to ensure the legitimacy of that person’s
1956 or entity’s request for the information:
1957 (a) The Attorney General and his or her designee when
1958 working on Medicaid fraud cases and Medicaid investigations
1959 involving prescribed controlled substances prescription drugs or
1960 when the Attorney General has initiated a review of specific
1961 identifiers of Medicaid fraud or specific identifiers that
1962 warrant a Medicaid investigation regarding prescribed controlled
1963 substances prescription drugs. The Attorney General or his or
1964 her designee may disclose the confidential and exempt
1965 information received from the department to a criminal justice
1966 agency as defined in s. 119.011 as part of an active
1967 investigation that is specific to a violation of prescription
1968 drug abuse or prescription drug diversion law as it relates to
1969 controlled substances. The Attorney General’s Medicaid fraud
1970 investigators and Medicaid investigators may not have direct
1971 access to the department’s database.
1972 (4) The department may disclose confidential and exempt
1973 information contained in records held by the department under s.
1974 893.055 if the State Surgeon General has entered into a
1975 reciprocal agreement for the sharing of prescription drug
1976 monitoring information with any other state that has a
1977 compatible prescription drug monitoring program.
1978 (a) The reciprocal agreement may allow the following
1979 persons from another state to receive information from the
1980 prescription drug monitoring program if approved by the State
1981 Surgeon General:
1982 1. A designated representative of a state professional
1983 licensing, certification, or regulatory agency charged with
1984 oversight of those persons authorized to prescribe or dispense
1985 controlled substances for the purpose of a bona fide, specific
1986 investigation of a prescription of a controlled substance which
1987 involves a designated person. As required in s. 893.055, this
1988 authorization does not preclude the requirement for the program
1989 manager to review the request for information and validate it.
1990 2. A health care practitioner or pharmacist licensed in the
1991 state from which the request originates. Such health care
1992 practitioner or pharmacist shall certify that the requested
1993 information is for the purpose of providing medical or
1994 pharmaceutical treatment to a bona fide, current patient. The
1995 health care practitioner or pharmacist shall follow all the
1996 procedures required in s. 893.055 and rules established by the
1997 department for a health care practitioner or pharmacist to
1998 request information from the database.
1999 3. A law enforcement officer from another state:
2000 a. Who is a member of a sheriff’s department or a police
2001 department;
2002 b. Who is authorized by law to conduct criminal
2003 investigations and make arrests;
2004 c. Whose duty it is to enforce the laws of his or her state
2005 relating to controlled substances; and
2006 d. Who is engaged in a bona fide specific, active
2007 investigation involving a designated person regarding
2008 prescriptions for controlled substances.
2009
2010 As required in s. 893.055, this authorization does not preclude
2011 the requirement for the program manager to review the request
2012 for information and validate it. This authorization also does
2013 not preclude the ability to provide a report to a law
2014 enforcement agency in another state under s. 893.055(7) or this
2015 subsection.
2016 (b) Any agreement between the State Surgeon General and
2017 another state shall prohibit the sharing of information
2018 concerning a resident of this state, a patient whose information
2019 is in the program’s database, or a practitioner, pharmacy,
2020 pharmacist, health care practitioner, or other prescriber for
2021 any purpose that is not otherwise authorized by this section or
2022 s. 893.055, and the information must be provided according to
2023 the State Surgeon General’s determination of compatibility as
2024 described in s. 893.055(17).
2025 Section 27. Subsections (1), (4), and (5) of section
2026 893.07, Florida Statutes, are amended, and subsection (6) is
2027 added to that section, to read:
2028 893.07 Records.—
2029 (1) Notwithstanding any other provision of law and in
2030 consonance with the authority of State v. Carter, 23 So. 3d 798
2031 (Fla. 1st DCA 2009) and State v. Tamulonis, 39 So. 3d 524 (Fla.
2032 2d DCA 2010), every person who engages in the manufacture,
2033 compounding, mixing, cultivating, growing, or by any other
2034 process producing or preparing, or in the dispensing,
2035 importation, or, as a wholesaler, distribution, of controlled
2036 substances shall:
2037 (a) On January 1, 1974, or as soon thereafter as any person
2038 first engages in such activity, and every second year
2039 thereafter, make a complete and accurate record of all stocks of
2040 controlled substances on hand. The inventory may be prepared on
2041 the regular physical inventory date which is nearest to, and
2042 does not vary by more than 6 months from, the biennial date that
2043 would otherwise apply. As additional substances are designated
2044 for control under this chapter, they shall be inventoried as
2045 provided for in this subsection.
2046 (b) On and after January 1, 1974, maintain, on a current
2047 basis, a complete and accurate record of each substance
2048 manufactured, received, sold, delivered, or otherwise disposed
2049 of by him or her, except that this subsection shall not require
2050 the maintenance of a perpetual inventory.
2051
2052 Compliance with the provisions of federal law pertaining to the
2053 keeping of records of controlled substances shall be deemed a
2054 compliance with the requirements of this subsection.
2055 (4) Every inventory or record required by this chapter,
2056 including prescription records, shall be maintained:
2057 (a) Separately from all other records of the registrant, or
2058 (b) Alternatively, in the case of Schedule III, IV, or V
2059 controlled substances, in such form that information required by
2060 this chapter is readily retrievable from the ordinary business
2061 records of the registrant.
2062
2063 In either case, such records described in this subsection shall
2064 be kept and made available for a period of at least 2 years for
2065 inspection and copying by law enforcement officers whose duty it
2066 is to enforce the laws of this state relating to controlled
2067 substances. This subsection does not require a law enforcement
2068 officer to obtain a subpoena, court order, or search warrant in
2069 order to obtain access to or copies of such records.
2070 (5) Each person shall maintain a record that contains which
2071 shall contain a detailed list of controlled substances lost,
2072 destroyed, or stolen, if any; the kind and quantity of such
2073 controlled substances; and the date of the discovering of such
2074 loss, destruction, or theft. If a person discovers the theft or
2075 significant loss of a controlled substance, such person shall
2076 report the theft or significant loss to a local county sheriff’s
2077 office within 48 hours after the discovery of such theft or
2078 loss. A person who fails to report the theft or significant loss
2079 of a controlled substance under this subsection commits a
2080 misdemeanor of the second degree, punishable as provided in s.
2081 775.082 or s. 775.083. However, a person who fails to report the
2082 theft or significant loss of a Schedule II controlled substance
2083 commits a misdemeanor of the first degree, punishable as
2084 provided in s. 775.082 or s. 775.083.
2085 (6) The Legislature finds that the opinions rendered in
2086 State v. Carter, 23 So. 3d 798 (Fla. 1st DCA 2009), and State v.
2087 Tamulonis, 39 So. 3d 524 (Fla. 2d DCA 2010), correctly construe
2088 this Legislature’s intent that the inspection powers previously
2089 conferred upon law enforcement officers which allow such
2090 officers to access and review pharmacy records concerning
2091 controlled substances are to be exercised properly by such law
2092 enforcement officers without the requirement of a subpoena or
2093 search warrant being sought or issued to examine and copy such
2094 records, and without the requirement that those persons to whom
2095 particular pharmacy records refer be given notice of the
2096 records’ examination and copying under this section.
2097 Section 28. Subsections (7) and (8) of section 893.13,
2098 Florida Statutes, are amended to read:
2099 893.13 Prohibited acts; penalties.—
2100 (7)(a) A It is unlawful for any person may not:
2101 1. To Distribute or dispense a controlled substance in
2102 violation of this chapter.
2103 2. To Refuse or fail to make, keep, or furnish any record,
2104 notification, order form, statement, invoice, or information
2105 required under this chapter.
2106 3. To Refuse an entry into any premises for any inspection
2107 or to refuse to allow any inspection authorized by this chapter.
2108 4. To Distribute a controlled substance named or described
2109 in s. 893.03(1) or (2) except pursuant to an order form as
2110 required by s. 893.06.
2111 5. To Keep or maintain any store, shop, warehouse,
2112 dwelling, building, vehicle, boat, aircraft, or other structure
2113 or place which is resorted to by persons using controlled
2114 substances in violation of this chapter for the purpose of using
2115 these substances, or which is used for keeping or selling them
2116 in violation of this chapter.
2117 6. To Use to his or her own personal advantage, or to
2118 reveal, any information obtained in enforcement of this chapter
2119 except in a prosecution or administrative hearing for a
2120 violation of this chapter.
2121 7. To Possess a prescription form which has not been
2122 completed and signed by the practitioner whose name appears
2123 printed thereon, unless the person is that practitioner, is an
2124 agent or employee of that practitioner, is a pharmacist, or is a
2125 supplier of prescription forms who is authorized by that
2126 practitioner to possess those forms.
2127 8. To Withhold information from a practitioner from whom
2128 the person seeks to obtain a controlled substance or a
2129 prescription for a controlled substance that the person making
2130 the request has received a controlled substance or a
2131 prescription for a controlled substance of like therapeutic use
2132 from another practitioner within the previous 30 days.
2133 9. To Acquire or obtain, or attempt to acquire or obtain,
2134 possession of a controlled substance by misrepresentation,
2135 fraud, forgery, deception, or subterfuge.
2136 10. To Affix any false or forged label to a package or
2137 receptacle containing a controlled substance.
2138 11. To Furnish false or fraudulent material information in,
2139 or omit any material information from, any report or other
2140 document required to be kept or filed under this chapter or any
2141 record required to be kept by this chapter.
2142 12. To Store anhydrous ammonia in a container that is not
2143 approved by the United States Department of Transportation to
2144 hold anhydrous ammonia or is not constructed in accordance with
2145 sound engineering, agricultural, or commercial practices.
2146 13. With the intent to obtain a controlled substance or
2147 combination of controlled substances that are not medically
2148 necessary for the person or an amount of a controlled substance
2149 or substances that are not medically necessary for the person,
2150 obtain or attempt to obtain from a practitioner a controlled
2151 substance or a prescription for a controlled substance by
2152 misrepresentation, fraud, forgery, deception, subterfuge, or
2153 concealment of a material fact. For purposes of this
2154 subparagraph, a material fact includes whether the person has an
2155 existing prescription for a controlled substance issued for the
2156 same period of time by another practitioner or as described in
2157 subparagraph 8.
2158 (b) A health care practitioner, with the intent to provide
2159 a controlled substance or combination of controlled substances
2160 that are not medically necessary to his or her patient or an
2161 amount of controlled substances that are not medically necessary
2162 for his or her patient, may not provide a controlled substance
2163 or a prescription for a controlled substance by
2164 misrepresentation, fraud, forgery, deception, subterfuge, or
2165 concealment of a material fact. For purposes of this paragraph,
2166 a material fact includes whether the patient has an existing
2167 prescription for a controlled substance issued for the same
2168 period of time by another practitioner or as described in
2169 subparagraph (a)8.
2170 (c) Any person who adulterates a controlled substance for
2171 directed off-label use without authorization by a prescribing
2172 physician violates the provisions of subparagraph (a)1. and
2173 causes the issuance of the entire prescription for the
2174 controlled substance to become invalid. A law enforcement
2175 officer in the performance of his or her official duties may
2176 seize the adulterated or off-label prescribed controlled
2177 substance as evidence. The controlled substance may be returned
2178 to the owner only with a notarized affidavit from the original
2179 prescribing practitioner who has knowledge and gave
2180 authorization and explicit directions for the adulteration or
2181 off-label use of the controlled substance.
2182 (d)(b) Any person who violates the provisions of
2183 subparagraphs (a)1.-7. commits a misdemeanor of the first
2184 degree, punishable as provided in s. 775.082 or s. 775.083;
2185 except that, upon a second or subsequent violation, the person
2186 commits a felony of the third degree, punishable as provided in
2187 s. 775.082, s. 775.083, or s. 775.084.
2188 (e)(c) Any person who violates the provisions of
2189 subparagraphs (a)8.-12. commits a felony of the third degree,
2190 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
2191 (f) A person or health care practitioner who violates the
2192 provisions of paragraph (b) or subparagraph (a)13. commits a
2193 felony of the third degree, punishable as provided in s.
2194 775.082, s. 775.083, or s. 775.084, if any controlled substance
2195 that is the subject of the offense is listed in Schedule II,
2196 Schedule III, or Schedule IV.
2197 (8)(a) Notwithstanding subsection (9), a prescribing
2198 practitioner may not:
2199 1. Knowingly assist a patient, other person, or the owner
2200 of an animal in obtaining a controlled substance through
2201 deceptive, untrue, or fraudulent representations in or related
2202 to the practice of the prescribing practitioner’s professional
2203 practice;
2204 2. Employ a trick or scheme in the practice of the
2205 prescribing practitioner’s professional practice to assist a
2206 patient, other person, or the owner of an animal in obtaining a
2207 controlled substance;
2208 3. Knowingly write a prescription for a controlled
2209 substance for a fictitious person; or
2210 4. Write a prescription for a controlled substance for a
2211 patient, other person, or an animal if the sole purpose of
2212 writing such prescription is to provide a monetary benefit to,
2213 or obtain a monetary benefit for, the prescribing practitioner;
2214 or.
2215 5. Write a prescription for a controlled substance for a
2216 patient, other person, or an animal and authorize or direct the
2217 adulteration of the dispensed form of the controlled substance
2218 for the purpose of ingestion by means of inhalation, injection,
2219 or any other means not medically necessary for the treatment of
2220 the patient.
2221 (b) If the prescribing practitioner wrote a prescription or
2222 multiple prescriptions for a controlled substance for the
2223 patient, other person, or animal for which there was no medical
2224 necessity, or which was in excess of what was medically
2225 necessary to treat the patient, other person, or animal, that
2226 fact does not give rise to any presumption that the prescribing
2227 practitioner violated subparagraph (a)1., but may be considered
2228 with other competent evidence in determining whether the
2229 prescribing practitioner knowingly assisted a patient, other
2230 person, or the owner of an animal to obtain a controlled
2231 substance in violation of subparagraph (a)1.
2232 (c) A person who violates paragraph (a) commits a felony of
2233 the third degree, punishable as provided in s. 775.082, s.
2234 775.083, or s. 775.084.
2235 (d) Notwithstanding paragraph (c), if a prescribing
2236 practitioner has violated paragraph (a) and received $1,000 or
2237 more in payment for writing one or more prescriptions or, in the
2238 case of a prescription written for a controlled substance
2239 described in s. 893.135, has written one or more prescriptions
2240 for a quantity of a controlled substance which, individually or
2241 in the aggregate, meets the threshold for the offense of
2242 trafficking in a controlled substance under s. 893.15, the
2243 violation is reclassified as a felony of the second degree and
2244 ranked in level 4 of the Criminal Punishment Code.
2245 Section 29. Present subsections (3) through (10) of section
2246 893.138, Florida Statutes, are redesignated as subsections (4)
2247 through (11), respectively, and a new subsection (3) is added to
2248 that section, to read:
2249 893.138 Local administrative action to abate drug-related,
2250 prostitution-related, or stolen-property-related public
2251 nuisances and criminal gang activity.—
2252 (3) Any pain-management clinic, as described in s. 458.3265
2253 or s. 459.0137, which has been used on more than two occasions
2254 within a 6-month period as the site of a violation of:
2255 (a) Section 784.011, s. 784.021, s. 784.03, or s. 784.045,
2256 relating to assault and battery;
2257 (b) Section 810.02, relating to burglary;
2258 (c) Section 812.014, relating to dealing in theft;
2259 (d) Section 812.131, relating to robbery by sudden
2260 snatching; or
2261 (e) Section 893.13, relating to the unlawful distribution
2262 of controlled substances,
2263
2264 may be declared to be a public nuisance, and such nuisance may
2265 be abated pursuant to the procedures provided in this section.
2266 Section 30. Subsection (9) is added to section 465.025,
2267 Florida Statutes, to read:
2268 465.025 Substitution of drugs.—
2269 (9) The board shall establish by rule a list of opioid
2270 drugs that incorporate tamper-resistant technology. Inclusion of
2271 a drug on the list does not require that the drug bear a
2272 labeling claim with respect to reduction of tampering, abuse, or
2273 abuse potential at the time of listing. The board shall make a
2274 determination whether to include a drug on the list based on a
2275 submission of evidence by the drug manufacturer or distributor
2276 that the drug:
2277 (a) Incorporates a tamper-resistance technology; and
2278 (b) Has been approved by the United States Food and Drug
2279 Administration pursuant to an application that includes at least
2280 one study on human tampering or abuse potential or a laboratory
2281 study comparing the tamper-resistant or abuse-resistant
2282 properties of the drug to one or more opioid drugs that have
2283 been approved by the United States Food and Drug Administration
2284 and serve as a positive control.
2285
2286 Notwithstanding subsection (2), a pharmacist may not substitute
2287 an opioid analgesic drug, either the brand name drug or generic
2288 drug, for an opioid analgesic drug incorporating a tamper
2289 resistance technology which was originally prescribed and is
2290 listed by the board pursuant to this subsection.
2291 Section 31. This act shall take effect October 1, 2011.