Florida Senate - 2010 SB 2272
By Senator Fasano
11-01256B-10 20102272__
1 A bill to be entitled
2 An act relating to pain management; amending s.
3 456.013, F.S.; requiring the Department of Health and
4 applicable boards within the Department of Health to
5 approve a mandatory continuing education course for
6 any practitioner who prescribes, administers, or
7 dispenses controlled substances that are listed in
8 Schedule II, Schedule III, or Schedule IV of ch. 893,
9 F.S.; requiring the training course to include certain
10 specified topics; providing that completion of the
11 course satisfies in part, the practitioner’s
12 continuing education requirements; authorizing the
13 department to exempt practitioners who have obtained
14 specialty training in or related to pain management;
15 providing dates of applicability for licensees and
16 initial applicants for licenses; requiring the
17 department to adopt rules to administer the training
18 requirements; amending s. 456.037, F.S.; providing
19 that pain-management clinics are business
20 establishments subject to licensure by the Department
21 of Health; requiring a health professional licensee
22 who works at a pain-management clinic that prescribes
23 controlled substances to be responsible for
24 maintaining control and security over his or her blank
25 prescription pads and any other method used to
26 prescribe controlled substance pain medication;
27 requiring the health professional licensee to notify
28 the department within a specified time of the theft or
29 loss of the blank prescription pads; requiring a
30 health professional licensee to give written notice to
31 the applicable board within a specified period after
32 the health professional licensee’s termination of
33 employment at the pain-management clinic; amending s.
34 456.057, F.S.; providing that the Department of Health
35 is not required to attempt to obtain authorization
36 from a patient for the release of the patient’s
37 medical records under certain circumstances; amending
38 s. 456.069, F.S.; authorizing the Department of Health
39 to inspect a pain-management clinic in a lawful manner
40 at all reasonable hours for the purpose of determining
41 if any provision of ch. 456, F.S., or any rule adopted
42 by the department has been violated; amending s.
43 456.071, F.S.; providing venue for judicial challenges
44 to any subpoena or order issued by the Department of
45 Health during its investigations; amending s. 456.072,
46 F.S.; providing additional acts that constitute
47 grounds for disciplinary actions against health
48 professional licensees; amending s. 456.309, F.S.;
49 requiring all privately owned pain-management clinics,
50 or offices that primarily engage in the treatment of
51 pain by prescribing or dispensing controlled substance
52 medications or employ a physician who is primarily
53 engaged in the treatment of pain by prescribing or
54 dispensing controlled substance medications, to
55 register with the Department of Health within a
56 specified time; providing an exception; authorizing
57 the department to deny an application for registering
58 a pain-management clinic or to revoke or suspend the
59 current registration certificate of a pain-management
60 clinic for certain reasons; authorizing the department
61 to impose fines for certain violations of law;
62 requiring the department to consider certain factors
63 when calculating the amount of the fine; providing
64 that each day constitutes an additional fine;
65 requiring the pain-management clinic to document in
66 writing all efforts undertaken by the pain-management
67 clinic to correct a violation; requiring a pain
68 management clinic to cease operating if its
69 registration certificate is revoked or suspended;
70 requiring certain named persons to remove all signs
71 and symbols identifying the premises as a pain
72 management clinic; prohibiting any person acting as an
73 individual or as part of a group from applying for a
74 certificate to operate a pain-management clinic for a
75 period of 5 years after the date the person’s
76 registration certificate was revoked; providing for
77 disposition of drugs at the former pain-management
78 clinic; requiring the department to adopt rules;
79 creating ss. 458.3265 and 459.0137, F.S.; providing
80 for requirements for the registration of pain
81 management clinics; prohibiting a physician or an
82 osteopathic physician from practicing medicine in a
83 pain-management clinic if the pain-management clinic
84 is not registered with the Department of Health;
85 requiring each location of a pain-management clinic to
86 be registered separately regardless of whether the
87 clinic is operated under the same business name or
88 management as another clinic; prohibiting a pain
89 management clinic from being owned by or having any
90 contractual relationship with certain specified
91 persons; providing that if the department finds that a
92 privately owned pain-management clinic is owned by a
93 person possessing disqualifying criteria, the
94 department shall refuse to register the pain
95 management clinic or revoke a previously issued
96 certificate of registration; requiring the owner,
97 operator, or designated physician to be responsible
98 for the onsite management of a pain-management clinic;
99 providing that an owner or operator who fails to
100 comply with certain stated conditions commits a
101 misdemeanor of the first degree; providing criminal
102 penalties; providing that only certain designated
103 persons may disperse medication; requiring a physician
104 to document in the patient’s record why the physician
105 is prescribing or dispensing more than a specified
106 amount of a controlled substances for the treatment of
107 chronic nonmalignant pain; defining terms; requiring,
108 on or after a specified date, any person submitting an
109 application for an initial or renewal registration
110 certificate to operate a pain-management clinic to
111 include certain specified information on the
112 application form to the department; requiring the
113 department to send to the Department of Law
114 Enforcement fingerprints as a part of an applicant’s
115 criminal history background check of registered
116 persons for a statewide criminal record check, and to
117 the Federal Bureau of Investigation for a national
118 criminal history record check; requiring each person
119 who applies for an initial or renewal registration to
120 pay the department a fee for the cost of preparing and
121 retaining the fingerprints and performing the ongoing
122 searches of arrest records; requiring the State
123 Surgeon General to order a pain-management clinic to
124 cease operations if the owner or operator of the pain
125 management clinic fails to pass a criminal history
126 background check; providing an exemption; requiring
127 the department and the Department of Law Enforcement
128 to adopt rules; amending ss. 458.327 and 459.013,
129 F.S.; providing that committing certain specified acts
130 while managing a pain-management clinic constitutes a
131 felony of the third degree or a misdemeanor of the
132 first degree; amending s. 459.005, F.S.; authorizing
133 the department to deny an application for registering
134 a pain-management clinic, or to revoke or suspend the
135 current registration for certain reasons; permitting
136 the department to impose fines for certain violations
137 of law; requiring the department to consider certain
138 factors when calculating the amount of the fine;
139 providing that each day constitutes an additional
140 fine; requiring a pain-management clinic to cease
141 operating as a pain-management clinic if its
142 registration is revoked or suspended; requiring
143 certain named persons to remove all signs and symbols
144 identifying the premises as a pain-management clinic;
145 prohibiting any person acting as an individual or as
146 part of a group, make application for a permit to
147 operate a pain-management clinic for a period of 5
148 years after the date the registration was revoked;
149 providing for disposition of drugs at the former pain
150 management clinic; requiring the department to adopt
151 certain rules; providing an effective date.
152
153 Be It Enacted by the Legislature of the State of Florida:
154
155 Section 1. Subsection (7) of section 456.013, Florida
156 Statutes, is amended to read:
157 456.013 Department; general licensing provisions.—
158 (7)(a) The boards, or the department when there is no
159 board, shall require the completion of a 2-hour course relating
160 to prevention of medical errors as part of the licensure and
161 renewal process. The 2-hour course shall count towards the total
162 number of continuing education hours required for the
163 profession. The course shall be approved by the board or
164 department, as appropriate, and shall include a study of root
165 cause analysis, error reduction and prevention, and patient
166 safety. In addition, the course approved by the Board of
167 Medicine and the Board of Osteopathic Medicine shall include
168 information relating to the five most misdiagnosed conditions
169 during the previous biennium, as determined by the board. If the
170 course is being offered by a facility licensed pursuant to
171 chapter 395 for its employees, the board may approve up to 1
172 hour of the 2-hour course to be specifically related to error
173 reduction and prevention methods used in that facility.
174 (b) The boards, or the department if there is no board,
175 shall require the completion of a 3-hour continuing education
176 course relating to prescribing, administering, or dispensing
177 controlled substances listed in Schedule II, Schedule III, or
178 Schedule IV, as set forth in s. 893.03, as a condition for
179 receiving an initial license or a license renewal. The course is
180 required for any practitioner licensed pursuant to chapter 458,
181 chapter 459, chapter 461, chapter 466, or chapter 457 who
182 prescribes, administers, or dispenses controlled substances. The
183 course must include, but need not be limited to:
184 1. The goals of administering controlled substances to
185 patients who require short-term and ongoing pain management;
186 2. The guidelines and rules for prescribing controlled
187 substances, including the use of a controlled substance
188 agreement;
189 3. The application of drug screening or drug testing to
190 patients, including instruction on the usefulness and
191 limitations of drug screening and drug testing;
192 4. The role of controlled substances in treating short-term
193 and ongoing pain syndromes, including instruction on the
194 usefulness and limitations of controlled substance in treating
195 pain;
196 5. The use of evidenced-based, noncontrolled-substance
197 pharmacological pain treatments on patients;
198 6. The use of evidenced-based, nonpharmacological pain
199 treatments on patients;
200 7. The importance of properly obtaining a full medical
201 history and completing a comprehensive physical examination of
202 patients;
203 8. The importance of keeping appropriate progress notes
204 during the care of patients;
205 9. The relationship of the co-occurring morbidities that
206 occur with pain disorders, such as psychiatric and addictive
207 disorders;
208 10. The identification and prevention of drug abuse and
209 drug diversion; and
210 11. The laws and rules of this state which govern the
211 prescription, administration, and distribution of controlled
212 substances.
213
214 The course hours must be included in the total number of hours
215 of continuing education required by the profession and must be
216 approved by the board, or by the department if there is no
217 board. A course offered under the auspices of a facility
218 licensed pursuant to chapter 395 for its employees must be
219 approved by the board, or by the department if there is no
220 board, if the course is at least 3 hours in duration and covers
221 the topic of prescribing, administering, and dispensing
222 controlled substances.
223 (c) The boards may exempt a licensee from the training
224 requirements set forth in paragraph (b) if the licensee has
225 obtained specialty or subspecialty certification in or related
226 to pain management from a specialty board recognized by the
227 respective board.
228 (d) The course requirements set forth in paragraph (b)
229 apply to each licensee when renewing his or her license
230 beginning on or after July 1, 2011, and to all applicants who
231 are approved for licensure on or after January 1, 2012.
232 (e) The boards, or the department if there is no board,
233 shall adopt rules to administer this subsection by July 1, 2011.
234 Section 2. Section 456.037, Florida Statutes, is amended to
235 read:
236 456.037 Business establishments; requirements for active
237 status licenses; delinquency; discipline; applicability.—
238 (1) A business establishment regulated by the Division of
239 Medical Quality Assurance pursuant to this chapter may provide
240 regulated services only if the business establishment has an
241 active status license. A business establishment that provides
242 regulated services without an active status license is in
243 violation of this section and s. 456.072, and the board, or the
244 department if there is no board, may impose discipline on the
245 business establishment.
246 (2) A business establishment must apply with a complete
247 application, as defined by rule of the board, or the department
248 if there is no board, to renew an active status license before
249 the license expires. If a business establishment fails to renew
250 before the license expires, the license becomes delinquent,
251 except as otherwise provided in statute, in the license cycle
252 following expiration.
253 (3) A delinquent business establishment must apply with a
254 complete application, as defined by rule of the board, or the
255 department if there is no board, for active status within 6
256 months after becoming delinquent. Failure of a delinquent
257 business establishment to renew the license within the 6 months
258 after the expiration date of the license renders the license
259 null without any further action by the board or the department.
260 Any subsequent licensure shall be as a result of applying for
261 and meeting all requirements imposed on a business establishment
262 for new licensure.
263 (4) The status or a change in status of a business
264 establishment license does not alter in any way the right of the
265 board, or of the department if there is no board, to impose
266 discipline or to enforce discipline previously imposed on a
267 business establishment for acts or omissions committed by the
268 business establishment while holding a license, whether active
269 or null.
270 (5) This section applies to any business establishment
271 registered, permitted, or licensed by the department to do
272 business. Business establishments include, but are not limited
273 to, dental laboratories, electrology facilities, massage
274 establishments, and pharmacies, and pain-management clinics
275 required to be registered under s. 458.309 or s. 459.005.
276 (6) A licensee authorized to prescribe controlled
277 substances who practices at a pain-management clinic is
278 responsible for maintaining the control and security of his or
279 her prescription blanks and any other method used for
280 prescribing controlled substance pain medication. The licensee
281 shall comply with the requirements for counterfeit-resistant
282 prescription blanks in s. 893.065 and the rules adopted pursuant
283 to that section. The licensee shall notify in writing:
284 (a) The department within 24 hours following any theft or
285 loss of a prescription blank or breach of any other method for
286 prescribing pain medication.
287 (b) The applicable board of the date of termination of
288 employment within 10 days after terminating his or her
289 employment with a pain-management clinic.
290 Section 3. Paragraph (a) of subsection (9) of section
291 456.057, Florida Statutes, is amended to read:
292 456.057 Ownership and control of patient records; report or
293 copies of records to be furnished.—
294 (9)(a)1. The department may obtain patient records pursuant
295 to a subpoena without written authorization from the patient if
296 the department and the probable cause panel of the appropriate
297 board, if any, find reasonable cause to believe that a health
298 care practitioner has excessively or inappropriately prescribed
299 any controlled substance specified in chapter 893 in violation
300 of this chapter or any professional practice act or that a
301 health care practitioner has practiced his or her profession
302 below that level of care, skill, and treatment required as
303 defined by this chapter or any professional practice act and
304 also find that appropriate, reasonable attempts were made to
305 obtain a patient release. Notwithstanding the foregoing, the
306 department need not attempt to obtain a patient release when
307 investigating an offense involving the inappropriate
308 prescribing, overprescribing, or diversion of controlled
309 substances and the offense involves a pain-management clinic.
310 2. The department may obtain patient records and insurance
311 information pursuant to a subpoena without written authorization
312 from the patient if the department and the probable cause panel
313 of the appropriate board, if any, find reasonable cause to
314 believe that a health care practitioner has provided inadequate
315 medical care based on termination of insurance and also find
316 that appropriate, reasonable attempts were made to obtain a
317 patient release.
318 3. The department may obtain patient records, billing
319 records, insurance information, provider contracts, and all
320 attachments thereto pursuant to a subpoena without written
321 authorization from the patient if the department and probable
322 cause panel of the appropriate board, if any, find reasonable
323 cause to believe that a health care practitioner has submitted a
324 claim, statement, or bill using a billing code that would result
325 in payment greater in amount than would be paid using a billing
326 code that accurately describes the services performed, requested
327 payment for services that were not performed by that health care
328 practitioner, used information derived from a written report of
329 an automobile accident generated pursuant to chapter 316 to
330 solicit or obtain patients personally or through an agent
331 regardless of whether the information is derived directly from
332 the report or a summary of that report or from another person,
333 solicited patients fraudulently, received a kickback as defined
334 in s. 456.054, violated the patient brokering provisions of s.
335 817.505, or presented or caused to be presented a false or
336 fraudulent insurance claim within the meaning of s.
337 817.234(1)(a), and also find that, within the meaning of s.
338 817.234(1)(a), patient authorization cannot be obtained because
339 the patient cannot be located or is deceased, incapacitated, or
340 suspected of being a participant in the fraud or scheme, and if
341 the subpoena is issued for specific and relevant records.
342 4. Notwithstanding subparagraphs 1.-3., when the department
343 investigates a professional liability claim or undertakes action
344 pursuant to s. 456.049 or s. 627.912, the department may obtain
345 patient records pursuant to a subpoena without written
346 authorization from the patient if the patient refuses to
347 cooperate or if the department attempts to obtain a patient
348 release and the failure to obtain the patient records would be
349 detrimental to the investigation.
350 Section 4. Section 456.069, Florida Statutes, is amended to
351 read:
352 456.069 Authority to inspect.—In addition to the authority
353 specified in s. 465.017, duly authorized agents and employees of
354 the department may shall have the power to inspect in a lawful
355 manner at all reasonable hours:
356 (1) Any pharmacy; or
357 (2) Any establishment at which the services of a licensee
358 authorized to prescribe controlled substances specified in
359 chapter 893 are offered; or,
360 (3) Any facility offering services that require the
361 facility to be registered as a pain-management clinic pursuant
362 to s. 458.309(4) or s. 459.005(3),
363
364 for the purpose of determining if any of the provisions of this
365 chapter or any practice act of a profession or any rule adopted
366 thereunder is being violated; or for the purpose of securing
367 such other evidence as may be needed for prosecution. Such
368 evidence may include, but is not limited to, patient records.
369 The department may obtain patient records without patient
370 authorization or subpoena from any pain-management clinic
371 required to be licensed if the department reasonably believes
372 that obtaining such authorization is not feasible due to the
373 volume of the dispensing and prescribing activity involving
374 controlled substances or that obtaining patient authorization or
375 the issuance of a subpoena would jeopardize the investigation.
376 Section 5. Section 456.071, Florida Statutes, is amended to
377 read:
378 456.071 Power to administer oaths, take depositions, and
379 issue subpoenas.—For the purpose of any investigation or
380 proceeding conducted by the department, the department shall
381 have the power to administer oaths, take depositions, make
382 inspections when authorized by statute, issue subpoenas which
383 shall be supported by affidavit, serve subpoenas and other
384 process, and compel the attendance of witnesses and the
385 production of books, papers, documents, and other evidence. The
386 department shall exercise this power on its own initiative or
387 whenever requested by a board or the probable cause panel of any
388 board. Challenges to, and enforcement of, the subpoenas and
389 orders shall be handled as provided in s. 120.569, except that
390 venue is in the Circuit Court for the Second Judicial Circuit,
391 in the county where the examination, investigation, or hearing
392 is conducted, or in the county in which the person resides.
393 Section 6. Paragraphs (mm), (nn), and (oo) are added to
394 subsection (1) of section 456.072, Florida Statutes, to read:
395 456.072 Grounds for discipline; penalties; enforcement.—
396 (1) The following acts shall constitute grounds for which
397 the disciplinary actions specified in subsection (2) may be
398 taken:
399 (mm) Applicable to a licensee who serves as the medical
400 director or the designated physician of a pain-management clinic
401 as defined in s. 458.305 or s. 459.005:
402 1. Registering a pain-management clinic through
403 misrepresentation or fraud or through an error of the department
404 or board;
405 2. Procuring, or attempting to procure, the registration of
406 a pain-management clinic for any other person by making or
407 causing to be made, any false representation;
408 3. Failing to comply with any requirement of chapter 499,
409 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
410 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
411 the Comprehensive Drug Abuse Prevention and Control Act; or
412 chapter 893;
413 4. Being convicted or found guilty of, regardless of
414 adjudication to, a felony or any other crime involving moral
415 turpitude fraud, dishonesty, or deceit in any jurisdiction of
416 the courts of this state, of any other state, or of the United
417 States;
418 5. Being convicted of, or disciplined by a regulatory
419 agency of the Federal Government or a regulatory agency of
420 another state for, any offense that would constitute a violation
421 of this chapter;
422 6. Being convicted of, or entering a plea of guilty or nolo
423 contendere to, regardless of adjudication, a crime in any
424 jurisdiction which relates to the practice of, or the ability to
425 practice, a licensed health care profession;
426 7. Being convicted of, or entering a plea of guilty or nolo
427 contendere to, regardless of adjudication, a crime in any
428 jurisdiction which relates to health care fraud;
429 8. Dispensing any medicinal drug based upon a communication
430 that purports to be a prescription as defined in s. 465.003(14)
431 or s. 893.02 if the dispensing practitioner knows or has reason
432 to believe that the purported prescription is not based upon a
433 valid practitioner-patient relationship; or
434 9. Failing to have a licensed medical director employed or
435 under contract with the clinic as required by chapter 400 or
436 failing to have the licensed designated physician practicing at
437 the location of the registered clinic.
438
439 A violation of this paragraph may be the basis for a summary
440 suspension as described in s. 456.073(8) or s. 120.60(6).
441 (nn) Failing to timely notify the department of the theft
442 of prescription blanks from a pain-management clinic or a breach
443 of other methods for prescribing within 24 hours as required by
444 s. 456.037(6).
445 (oo) Failing to timely notify the applicable board
446 governing his or her prescribing privileges of the date of his
447 or her termination from a pain-management clinic as required by
448 s. 456.037(6).
449 Section 7. Section 458.309, Florida Statutes, is amended to
450 read:
451 458.309 Rulemaking authority.—
452 (1) The board has authority to adopt rules pursuant to ss.
453 120.536(1) and 120.54 to implement the provisions of this
454 chapter conferring duties upon it.
455 (2)(a) Any rules which the board adopts relating to the
456 classroom phase of medical education shall not apply to any
457 person who is enrolled in the classroom phase of medical
458 education or has graduated prior to or at the time the rule
459 becomes effective, so long as such person does not interrupt his
460 or her medical education.
461 (b)1. Any rules which the board adopts relating to the
462 clinical clerkship phase of medical education shall not apply to
463 any person who is enrolled in the clinical clerkship phase of
464 medical education prior to or at the time the rule becomes
465 effective, so long as such person does not interrupt his or her
466 medical education.
467 2. Rules adopted by the Florida Board of Medical Examiners
468 prior to October 1, 1986, and relating to clinical clerkships
469 for graduates of foreign medical schools do not apply to any
470 such graduate who:
471 a. Had completed a clinical clerkship prior to the
472 effective date of the rule; or
473 b. Had begun a clinical clerkship but had not completed the
474 clinical clerkship prior to the effective date of the rule, so
475 long as the clinical clerkship took no longer than 3 years to
476 complete.
477 (c) Any rules which the board adopts relating to residency
478 shall not apply to any person who has begun his or her residency
479 prior to or at the time the rule becomes effective, so long as
480 such person does not interrupt the residency.
481 (3) All physicians who perform level 2 procedures lasting
482 more than 5 minutes and all level 3 surgical procedures in an
483 office setting must register the office with the department
484 unless that office is licensed as a facility pursuant to chapter
485 395. The department shall inspect the physician’s office
486 annually unless the office is accredited by a nationally
487 recognized accrediting agency or an accrediting organization
488 subsequently approved by the Board of Medicine. The actual costs
489 for registration and inspection or accreditation shall be paid
490 by the person seeking to register and operate the office setting
491 in which office surgery is performed.
492 (4) Effective January 4, 2010, all privately owned pain
493 management clinics, facilities, or offices primarily engaged in
494 the treatment of pain by prescribing or dispensing controlled
495 substance medications, hereinafter referred to as “clinics,”
496 which advertise in any medium for any type of pain-management
497 services, or employ a physician who is primarily engaged in the
498 treatment of pain by prescribing or dispensing controlled
499 substance medications, must register with the department by
500 January 4, 2010, unless that clinic is licensed as a facility
501 pursuant to chapter 395. A physician may not practice medicine
502 in a pain-management clinic that is required to but has not
503 registered with the department. Each clinic location shall be
504 registered separately regardless of whether the clinic is
505 operated under the same business name or management as another
506 clinic. If the clinic is licensed as a health care clinic under
507 chapter 400, the medical director is responsible for registering
508 the facility with the department. If the clinic is not
509 registered pursuant to chapter 395 or chapter 400, the clinic
510 shall, upon registration with the department, designate a
511 physician who is responsible for complying with all requirements
512 related to registration of the clinic. The designated physician
513 shall have a full, active, and unencumbered license be licensed
514 under this chapter or chapter 459 and shall practice at the
515 office location for which the physician has assumed
516 responsibility. The department shall inspect the clinic
517 annually, including a review of patient records, to ensure that
518 it complies with rules of the Board of Medicine adopted pursuant
519 to this subsection and subsection (8) (5) unless the office is
520 accredited by a nationally recognized accrediting agency
521 approved by the Board of Medicine. The actual costs for
522 registration and inspection or accreditation shall be paid by
523 the physician seeking to register the clinic.
524 (5)(a) The department may deny an application for
525 registering a pain-management clinic or revoke or suspend a
526 current registration. The department may impose an
527 administrative fine on the clinic of up to $5,000 per violation
528 for violating the requirements of this section, chapter 499, the
529 Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
530 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
531 the Comprehensive Drug Abuse Prevention and Control Act; chapter
532 893; or the rules of the department. In determining whether a
533 penalty is to be imposed, and in fixing the amount of the fine,
534 the department shall consider the following factors:
535 1. The gravity of the violation, including the probability
536 that death or serious physical or emotional harm to a patient
537 has resulted, or could have resulted, from a licensee’s actions,
538 the severity of the action or potential harm, and the extent to
539 which the provisions of the applicable laws or rules were
540 violated.
541 2. What actions, if any, the owner, medical director, or
542 designated physician took to correct the violations.
543 3. Whether there were any previous violations at the pain
544 management clinic.
545 4. The financial benefits that the pain-management clinic
546 derived from committing or continuing to commit the violation.
547 (b) Each day a violation continues after the date fixed for
548 termination as ordered by the department, constitutes an
549 additional, separate, and distinct violation.
550 (c) Any action taken to correct a violation shall be
551 documented in writing by the owner, medical director, or
552 designated physician of the pain-management clinic and verified
553 by followup visits by departmental personnel. The department may
554 impose a fine and, in the case of an owner-operated pain
555 management clinic, revoke or deny a clinic’s license if the
556 medical director of the pain-management clinic, or the clinic’s
557 designated physician, knowingly and intentionally misrepresents
558 actions taken to correct a violation.
559 (d) An owner, medical director, or designated physician of
560 a pain-management clinic who concurrently operates an unlicensed
561 pain-management clinic is subject to an administrative fine of
562 $5,000 per day.
563 (e) Any pain-management clinic whose owner fails to apply
564 for a change-of-ownership license and operates the clinic under
565 the new ownership is subject to a fine of $5,000.
566 (f) During an onsite inspection, the department shall make
567 a reasonable attempt to discuss each violation with the owner,
568 medical director, or designated physician of the pain-management
569 clinic before issuing a formal written notification.
570 (g)1. If the registration of a pain-management clinic is
571 revoked or suspended, the designated physician or medical
572 director of the pain-management clinic, the owner or lessor of
573 the pain-management clinic property, and the owner, manager, or
574 proprietor shall cease to operate the facility as a pain
575 management clinic as of the effective date of the suspension or
576 revocation.
577 2. If a pain-management clinic registration is revoked or
578 suspended, the designated physician or medical director of the
579 pain-management clinic, the owner or lessor of the clinic
580 property, or the owner, manager, or proprietor is responsible
581 for removing all signs and symbols identifying the premises as a
582 pain-management clinic.
583 3. If the clinic’s registration is revoked, any person
584 named in the registration documents of the pain-management
585 clinic, including persons owning or operating the pain
586 management clinic, may not as an individual or as a part of a
587 group, make application for a permit to operate a pain
588 management clinic for 5 years after the date the registration is
589 revoked.
590 4. Upon the effective date of the suspension or revocation,
591 the pain-management clinic shall advise the department of the
592 disposition of the medicinal drugs located on the premises. The
593 disposition is subject to the supervision and approval of the
594 department. Failure by a pain-management clinic to be registered
595 as required by law is cause for all medicinal drugs purchased or
596 held by the pain-management clinic to be adulterated pursuant to
597 s. 499.006.
598 5. The period of the suspension shall be prescribed by the
599 department, but may not exceed 1 year.
600 (6) The department shall adopt rules necessary to
601 administer the registration and inspection of pain-management
602 clinics establishing the specific requirements, procedures,
603 forms, and fees.
604 (7) The department shall adopt a rule defining what
605 constitutes practice by a designated physician at the office
606 location for which the physician has assumed responsibility, as
607 set forth in subsections (3) and (4). When adopting the rule,
608 the department shall consider the number of clinic employees,
609 the location of the pain-management clinic, its hours of
610 operation, and the amount of controlled substances being
611 prescribed, dispensed, or administered at the pain-management
612 clinic.
613 (8)(5) The Board of Medicine shall adopt rules setting
614 forth standards of practice for physicians practicing in
615 privately owned pain-management clinics that primarily engage in
616 the treatment of pain by prescribing or dispensing controlled
617 substance medications. Such rules shall address, but need not be
618 limited to, the following subjects:
619 (a) Facility operations;
620 (b) Physical operations;
621 (c) Infection control requirements;
622 (d) Health and safety requirements;
623 (e) Quality assurance requirements;
624 (f) Patient records;
625 (g) Training requirements for all facility health care
626 practitioners who are not regulated by another board;
627 (h) Inspections; and
628 (i) Data collection and reporting requirements.
629
630 A physician is primarily engaged in the treatment of pain by
631 prescribing or dispensing controlled substance medications when
632 the majority of the patients seen are prescribed or dispensed
633 controlled substance medications for the treatment of chronic
634 nonmalignant pain. Chronic nonmalignant pain is pain unrelated
635 to cancer which persists beyond the usual course of the disease
636 or the injury that is the cause of the pain or more than 90 days
637 after surgery.
638 (9)(6) A privately owned clinic, facility, or office that
639 advertises in any medium for any type of pain-management
640 services or employs one or more physicians who are primarily
641 engaged in the treatment of pain by prescribing or dispensing
642 controlled substances is exempt from the registration provisions
643 in subsection (4) if the majority of the physicians who provide
644 services in the clinic, facility, or office primarily provide
645 surgical services.
646 Section 8. Section 458.3265, Florida Statutes, is created
647 to read:
648 458.3265 Pain-management clinics.—
649 (1)(a) A physician may not practice medicine in a pain
650 management clinic, as described in s. 458.309(4), if the pain
651 management clinic is not registered with the department as
652 required by that section. As provided in s. 458.309(4), each
653 location of a pain-management clinic must be registered
654 separately regardless of whether the clinic is operated under
655 the same business name or management as another clinic. If a
656 pain-management clinic fails an annual inspection, the
657 department may revoke the clinic’s certificate of registration
658 and prohibit all physicians associated with that pain-management
659 clinic from practicing at that office location. A physician who
660 violates this paragraph is subject to review by his or her
661 appropriate medical regulatory board.
662 (b) A pain-management clinic may not be owned, in whole or
663 in part, by or have any contractual relationship, whether
664 through employment or by independent contract, with:
665 1. A physician who during the course of his or her practice
666 has been denied the privilege of prescribing, dispensing,
667 administering, supplying, or selling any controlled substance or
668 who has, during the course of his or her practice, had the board
669 take disciplinary action in this state or any other state or by
670 the United States, against his or her medical license as a
671 result of violating laws or rules relating to prescribing or
672 dispensing controlled substances or for his or her dependency on
673 drugs or alcohol.
674 2. A person whose application for a license to prescribe,
675 dispense, or administer a controlled substance has been denied
676 by any jurisdiction.
677 3. The holder of a license issued by any jurisdiction which
678 allowed the owner, employee, or person to prescribe, dispense,
679 or administer a controlled substance and which has been
680 restricted or revoked by the issuing jurisdiction.
681 4. A person who is the subject of a disciplinary proceeding
682 by any licensing entity for conduct resulting from
683 inappropriately prescribing, dispensing, or administering a
684 controlled substance.
685 5. A person who has been convicted of or pled guilty or
686 nolo contendere to, regardless of adjudication, an offense that
687 constitutes a felony or a misdemeanor for receipt of illicit and
688 diverted drugs, including a controlled substance listed in
689 Schedule I, Schedule II, Schedule III, Schedule IV, or Schedule
690 V of s. 893.03, in this state, any other state, or the United
691 States.
692 (c) If the department finds that a privately owned pain
693 management clinic is owned, directly or indirectly, by a person
694 meeting any criteria listed in paragraph (b), the department
695 shall refuse to register the pain-management clinic or shall
696 revoke the certificate of registration previously issued by the
697 department. As determined by rule, the department may grant an
698 exemption if more than 10 years have elapsed since adjudication.
699 As used in this subsection, the term “convicted” includes an
700 adjudication of guilt following a plea of guilty or nolo
701 contendere or the forfeiture of a bond when charged with a
702 crime.
703 (d) The owner, operator, or designated physician of a pain
704 management clinic shall:
705 1. Be onsite at the pain-management clinic for at least 33
706 percent of the operating hours of the pain-management clinic,
707 with exemptions provided by department rule. If this requirement
708 is not met by a designated physician, the owner or operator
709 shall be physically present at the pain-management clinic at
710 least once a week to inspect the facility in accordance with
711 department rule. Exemptions may be provided by department rule
712 if the designated physician, owner, or operator is present
713 weekly and conducts inspections; and
714 2. Review on a weekly basis at least 33 percent of the
715 total number of patient files of the clinic, including the
716 patient files in the possession of a clinic employee or
717 contractor to whom authority for patient care has been delegated
718 by the pain-management clinic, with exemptions provided by
719 department rule.
720 (e) A violation of this subsection is grounds for
721 disciplinary action against the clinic, its owner, its operator,
722 or designated physician under s. 458.309. An owner or operator
723 who fails to comply with this subsection commits a misdemeanor
724 of the first degree, punishable as provided in s. 775.082 or s.
725 775.083.
726 (2) A person may not dispense any medication, including a
727 controlled substance, on the premises of a pain-management
728 clinic unless he or she is a physician licensed under this
729 chapter or chapter 459; however, a pharmacist licensed under
730 chapter 465 may dispense any medication, including a controlled
731 substance, on the premises of a pain-management clinic.
732 (3) After a physical examination of the patient the same
733 day of dispensing a controlled substance, a physician must
734 document in the patient’s record the reason for prescribing or
735 dispensing more than a 72-hour dose of a controlled substance
736 for the treatment of chronic nonmalignant pain. A physician
737 shall follow the department’s rules for treating pain when
738 prescribing the use of controlled substances and dispensing
739 controlled substances. The failure to follow the department’s
740 rules is grounds for disciplinary action by the Board of
741 Medicine and the possible revocation of the clinic’s certificate
742 of registration by the department.
743 (4) As used in subsections (4) through (8), the term:
744 (a) “Controlled substance” means a controlled substance
745 listed in Schedule II, Schedule III, or Schedule IV of s.
746 893.03.
747 (b) “Parties affiliated with a pain-management clinic”
748 means:
749 1. A director, officer, trustee, partner, or committee
750 member of a pain-management clinic or applicant, or a subsidiary
751 or service corporation of the pain-management clinic or
752 applicant; or
753 2. A person who, directly or indirectly, manages, controls,
754 or oversees the operation of a pain-management clinic or
755 applicant, regardless of whether the person is a partner,
756 shareholder, manager, member, officer, director, independent
757 contractor, or employee of the pain-management clinic or
758 applicant.
759 (5) On or after January 3, 2011, an application for an
760 initial or renewal registration of a pain-management clinic must
761 include:
762 (a) The name, full business address, and telephone number
763 of the applicant.
764 (b) All trade or business names used by the applicant.
765 (c) The address, telephone numbers, and names of contact
766 persons for each facility used by the applicant for the
767 prescribing or dispensing of controlled substance medications in
768 the treatment of pain.
769 (d) The type of ownership or operation, such as a
770 partnership, corporation, or sole proprietorship.
771 (e) The names of each owner and each operator of the pain
772 management clinic, including:
773 1. If an individual, the name of the individual.
774 2. If a partnership, the name of each partner and the name
775 of the partnership.
776 3. If a corporation:
777 a. The name, address, and title of each corporate officer
778 and director.
779 b. The name and address of the corporation and the resident
780 agent of the corporation, the resident agent’s address, and the
781 corporation’s state of incorporation.
782 c. The name and address of each shareholder of the
783 corporation owning 5 percent or more of the outstanding stock of
784 the corporation.
785 4. If a sole proprietorship, the full name of the sole
786 proprietor and the name of the business entity.
787 5. If a limited liability company:
788 a. The name and address of each member.
789 b. The name and address of each manager.
790 c. The name and address of the limited liability company,
791 the resident agent of the limited liability company, and the
792 name of the state in which the limited liability company was
793 organized.
794 (f) The tax year of the applicant.
795 (g) A copy of the deed for the property on which the
796 applicant’s pain-management clinic is located, if the clinic is
797 owned by the applicant, or a copy of the applicant’s lease for
798 the property on which the applicant’s pain-management clinic is
799 located, which must have an original term of not less than 1
800 calendar year, if the pain-management clinic is not owned by the
801 applicant.
802 (h) A list of all licenses and permits issued to the
803 applicant by any other state which authorize the applicant to
804 purchase or possess prescription drugs.
805 (i) The name of the manager of the pain-management clinic
806 that is applying for the initial or renewal registration, the
807 next four highest ranking employees responsible for operations
808 of the pain-management clinic, the name of all parties
809 affiliated with the pain-management clinic, and the personal
810 information statement and set of fingerprints required under
811 subsection (6) for each person.
812 (6)(a) Each person required by subsection (5) to provide a
813 personal information statement and fingerprints shall provide
814 the following information to the department on forms prescribed
815 by the department:
816 1. The person’s places of residence for the past 7 years.
817 2. The person’s date and place of birth.
818 3. The person’s occupations, positions of employment, and
819 offices held during the past 7 years.
820 4. The principal business and address of any business,
821 corporation, or other organization in which the person:
822 a. Held an office during the past 7 years; or
823 b. Had an occupation or position of employment during the
824 past 7 years.
825 5. Whether the person has been, during the past 7 years,
826 the subject of any proceeding for the revocation of any license
827 and, if so, the nature of the proceeding and the disposition of
828 the proceeding.
829 6. Whether, during the past 7 years, the person has been
830 enjoined, temporarily or permanently, by a court of competent
831 jurisdiction from violating any federal or state law regulating
832 the possession, control, or distribution of controlled
833 substances, together with details concerning any such event.
834 7. A description of any involvement by the person during
835 the past 7 years, including any investments, other than the
836 ownership of stock in a publicly traded company or mutual fund,
837 with any business that manufactured, administered, prescribed,
838 distributed, or stored pharmaceutical products and any lawsuits
839 in which the businesses were named as a party.
840 8. A description of any felony criminal offense of which
841 the person, as an adult, was found guilty, regardless of whether
842 adjudication of guilt was withheld or whether the person pled
843 guilty or nolo contendere. A criminal offense committed in
844 another jurisdiction which would have been a felony in this
845 state must be reported. If the person indicates that a criminal
846 conviction is under appeal and submits a copy of the notice of
847 appeal of that criminal offense, the applicant shall, within 15
848 days after the disposition of the appeal, submit to the
849 department a copy of the final written order of disposition.
850 9. A photograph of the person taken in the previous 30
851 days.
852 10. A set of fingerprints from the person on a form and
853 under procedures specified by the department and payment of a
854 fee equal to the cost incurred by the department for the
855 criminal history record check of the person.
856 11. The name, address, occupation, and date and place of
857 birth for each member of the person’s immediate family who is 18
858 years of age or older. As used in this subparagraph, the term
859 “member of the person’s immediate family” includes the person’s
860 spouse, children, parents, siblings, the spouses of the person’s
861 children, and the spouses of the person’s siblings.
862 12. Any other relevant information that the department
863 requires.
864 (b) The information required under paragraph (a) shall be
865 provided under oath.
866 (c)1. The department shall submit the fingerprints provided
867 with an application for initial registration on or after January
868 4, 2010, to the Department of Law Enforcement for a statewide
869 criminal record check and for forwarding to the Federal Bureau
870 of Investigation for a national criminal record check.
871 2. For the renewal of a registration on or after January 3,
872 2011, the department shall submit the fingerprints provided as a
873 part of a renewal application and background check of registered
874 persons to the Department of Law Enforcement for a statewide
875 criminal record check, and for forwarding to the Federal Bureau
876 of Investigation for a national criminal record check. For any
877 subsequent renewal of a registration, the department shall
878 submit the required information for a statewide and national
879 criminal record check.
880 3. Any person who submits to the department a set of
881 fingerprints for a criminal record check is not required to
882 provide a subsequent set of fingerprints for a criminal record
883 check if the person has undergone a criminal record check with
884 submission of fingerprints for background screening as a
885 condition of the issuance of an initial registration or the
886 initial renewal of a registration on or after January 4, 2010.
887 4. The department shall submit fingerprints for those
888 undergoing a background screening and they must be submitted
889 electronically. The department shall screen background results
890 to determine if an applicant meets registration requirements.
891 5. The cost for the processing fingerprints for an initial
892 or renewal registration must be borne by the person subject to
893 the background check. The Department of Law Enforcement shall
894 receive payment for processing the fingerprints submitted to it
895 each month by invoice to the Department of Health or by credit
896 card from the applicant or a vendor acting on behalf of the
897 applicant.
898 6. All fingerprints submitted to the Department of Law
899 Enforcement shall be retained by the Department of Law
900 Enforcement in a manner provided by rule and entered into the
901 statewide automated fingerprint identification system authorized
902 by s. 943.05(2)(b). The fingerprints shall thereafter be
903 available for all purposes and uses authorized for arrest
904 fingerprint cards entered in the statewide automated fingerprint
905 identification system pursuant to s. 943.051.
906 7. Fingerprints for arrests submitted or received under s.
907 943.051 shall be searched against the fingerprints retained in
908 the statewide automated fingerprint identification system. Any
909 arrest record that is identified with the retained fingerprints
910 of a person subject to the background screening under this
911 section shall be reported to the department.
912 8. Each person shall pay to the department a fee for the
913 cost of retaining the fingerprints and performing the ongoing
914 searches of arrest records. The Department of Law Enforcement
915 shall receive payment for processing and retaining the
916 fingerprints submitted to it each month by invoice to the
917 Department of Health or by credit card from the applicant or a
918 vendor acting on behalf of the applicant.
919 9. The Department of Law Enforcement shall adopt rules
920 establishing the amount of the fee and procedures for retaining
921 the fingerprints, performing the searches, and disseminating the
922 search results. The department shall notify the Department of
923 Law Enforcement of any change in a person’s status as a person
924 listed s. 458.3265 if, as a result of the change, the person’s
925 fingerprints are no longer required to be retained under
926 paragraph (a).
927 (7) The State Surgeon General shall order a clinic closed
928 for operations if closure is warranted following failure of the
929 owner or operator of the pain-management clinic to pass a
930 background check of his or her criminal history. As determined
931 by rule, the department may grant an exemption if more than 10
932 years have elapsed since adjudication.
933 (8) By January 3, 2011, the department and the Department
934 of Law Enforcement shall adopt rules pursuant to ss. 120.536(1)
935 and 120.54 to administer the provisions of this section, which
936 shall include, as necessary, the reporting, management,
937 development, and implementation of the fingerprint requirements
938 in this section.
939 Section 9. Paragraph (e) is added to subsection (1) of
940 section 458.327, Florida Statutes, and paragraph (f) is added to
941 subsection (2) of that section, to read:
942 458.327 Penalty for violations.—
943 (1) Each of the following acts constitutes a felony of the
944 third degree, punishable as provided in s. 775.082, s. 775.083,
945 or s. 775.084:
946 (e) Knowingly operating, owning, or managing a
947 nonregistered pain-management clinic that is required to be
948 registered with the Department of Health pursuant to s.
949 458.309(4).
950 (2) Each of the following acts constitutes a misdemeanor of
951 the first degree, punishable as provided in s. 775.082 or s.
952 775.083:
953 (f) Knowingly prescribing or dispensing, or causing to be
954 prescribed or dispensed, controlled substances in a
955 nonregistered pain-management clinic that is required to be
956 registered with the Department of Health pursuant to s.
957 458.309(4).
958 Section 10. Section 459.005, Florida Statutes, is amended
959 to read:
960 459.005 Rulemaking authority.—
961 (1) The department and the board may has authority to adopt
962 rules pursuant to ss. 120.536(1) and 120.54 to implement the
963 provisions of this chapter conferring duties upon it.
964 (2) All physicians who perform level 2 procedures lasting
965 more than 5 minutes and all level 3 surgical procedures in an
966 office setting must register the office with the department
967 unless that office is licensed as a facility pursuant to chapter
968 395. The department shall inspect the physician’s office
969 annually unless the office is accredited by a nationally
970 recognized accrediting agency or an accrediting organization
971 subsequently approved by the Board of Osteopathic Medicine. The
972 actual costs for registration and inspection or accreditation
973 shall be paid by the person seeking to register and operate the
974 office setting in which office surgery is performed.
975 (3) Effective January 4, 2010, all privately owned pain
976 management clinics, facilities, or offices, primarily engaged in
977 the treatment of pain by prescribing or dispensing controlled
978 substance medications, hereinafter referred to as “clinics,”
979 which advertise in any medium for any type of pain-management
980 services, or employ a physician who is licensed under this
981 chapter and who is primarily engaged in the treatment of pain by
982 prescribing or dispensing controlled substance medications, must
983 register with the department by January 4, 2010, unless that
984 clinic is licensed as a facility under chapter 395. A physician
985 may not practice osteopathic medicine in a pain-management
986 clinic that is required to but has not registered with the
987 department. Each clinic location shall be registered separately
988 regardless of whether the clinic is operated under the same
989 business name or management as another clinic. If the clinic is
990 licensed as a health care clinic under chapter 400, the medical
991 director is responsible for registering the facility with the
992 department. If the clinic is not registered under chapter 395 or
993 chapter 400, the clinic shall, upon registration with the
994 department, designate a physician who is responsible for
995 complying with all requirements related to registration of the
996 clinic. The designated physician shall have a full, active, and
997 unencumbered license be licensed under chapter 458 or this
998 chapter and shall practice at the office location for which the
999 physician has assumed responsibility. The department shall
1000 inspect the clinic annually to ensure that it complies with
1001 rules of the Board of Osteopathic Medicine adopted pursuant to
1002 this subsection and subsection (7)(4) unless the office is
1003 accredited by a nationally recognized accrediting agency
1004 approved by the Board of Osteopathic Medicine. The actual costs
1005 for registration and inspection or accreditation shall be paid
1006 by the physician seeking to register the clinic.
1007 (4)(a) The department may deny an application for
1008 registering a pain-management clinic or revoke or suspend a
1009 current registration. The department may impose an
1010 administrative fine on the clinic of up to $5,000 per violation
1011 for violating the requirements of this section, chapter 499, the
1012 Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
1013 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
1014 the Comprehensive Drug Abuse Prevention and Control Act; chapter
1015 893; or the rules of the department. In determining whether a
1016 penalty is to be imposed, and in fixing the amount of the fine,
1017 the department shall consider the following factors:
1018 1. The gravity of the violation, including the probability
1019 that death or serious physical or emotional harm to a patient
1020 has resulted, or could have resulted, from a licensee’s actions,
1021 the severity of the action or potential harm, and the extent to
1022 which the provisions of the applicable laws or rules were
1023 violated.
1024 2. What actions, if any, the owner, medical director, or
1025 designated physician took to correct the violations.
1026 3. Whether there were any previous violations at the pain
1027 management clinic.
1028 4. The financial benefits that the pain-management clinic
1029 derived from committing or continuing to commit the violation.
1030 (b) Each day a violation continues after the date fixed for
1031 termination as ordered by the department, constitutes an
1032 additional, separate, and distinct violation.
1033 (c) Any action taken to correct a violation shall be
1034 documented in writing by the owner, medical director, or
1035 designated physician of the pain-management clinic and verified
1036 by followup visits by department personnel. The department may
1037 impose a fine and, in the case of an owner-operated pain
1038 management clinic, revoke or deny a clinic’s license if the
1039 medical director of the pain-management clinic, or the clinic’s
1040 designated physician, knowingly and intentionally misrepresents
1041 actions taken to correct a violation.
1042 (d) An owner, medical director, or designated physician of
1043 a pain-management clinic who concurrently operates an unlicensed
1044 pain-management clinic is subject to an administrative fine of
1045 $5,000 per day.
1046 (e) Any pain-management clinic whose owner fails to apply
1047 for a change-of-ownership license and operates the clinic under
1048 the new ownership is subject to a fine of $5,000.
1049 (f) During an onsite inspection, the department shall make
1050 a reasonable attempt to discuss each violation with the owner,
1051 medical director, or designated physician of the pain-management
1052 clinic before issuing a formal written notification.
1053 (g)1. If the registration of a pain-management clinic is
1054 revoked or suspended, the designated physician or medical
1055 director of the pain-management clinic, the owner or lessor of
1056 the pain-management clinic property, and the owner, manager, or
1057 proprietor shall cease to operate the facility as a pain
1058 management clinic as of the effective date of the suspension or
1059 revocation.
1060 2. If a pain-management clinic registration is revoked or
1061 suspended, the designated physician or medical director of the
1062 pain-management clinic, the owner or lessor of the clinic
1063 property, and the owner, manager, or proprietor are responsible
1064 for removing all signs and symbols identifying the premises as a
1065 pain-management clinic.
1066 3. If the clinic’s registration is revoked, any person
1067 named in the registration documents of the pain-management
1068 clinic, including persons owning or operating the pain
1069 management clinic, may not as an individual or as a part of a
1070 group, make application for a permit to operate a pain
1071 management clinic for 5 years after the date the registration is
1072 revoked.
1073 4. Upon the effective date of the suspension or revocation,
1074 the pain-management clinic shall advise the department of the
1075 disposition of the medicinal drugs located on the premises. The
1076 disposition is subject to the supervision and approval of the
1077 department. Failure by a pain-management clinic to be registered
1078 as required by law is cause for all medicinal drugs purchased or
1079 held by the pain-management clinic to be adulterated pursuant to
1080 s. 499.006.
1081 5. The period of the suspension shall be prescribed by the
1082 department, but may not exceed 1 year.
1083 (5) The department shall adopt rules necessary to
1084 administer the registration and inspection of pain-management
1085 clinics establishing the specific requirements, procedures,
1086 forms, and fees.
1087 (6) The department shall adopt a rule defining what
1088 constitutes practice by a designated physician at the office
1089 location for which the physician has assumed responsibility as
1090 set forth in subsection (4). When adopting the rule, the
1091 department shall consider the number of clinic employees, the
1092 location of the pain-management clinic, its hours of operation,
1093 and the amount of controlled substances being prescribed,
1094 dispensed, or administered at the pain-management clinic.
1095 (7)(4) The Board of Osteopathic Medicine shall adopt rules
1096 setting forth standards of practice for physicians who practice
1097 in privately owned pain-management clinics that primarily engage
1098 in the treatment of pain by prescribing or dispensing controlled
1099 substance medications. The Such rules shall address, but need
1100 not be limited to, the following subjects:
1101 (a) Facility operations;
1102 (b) Physical operations;
1103 (c) Infection control requirements;
1104 (d) Health and safety requirements;
1105 (e) Quality assurance requirements;
1106 (f) Patient records;
1107 (g) Training requirements for all facility health care
1108 practitioners who are not regulated by another board;
1109 (h) Inspections; and
1110 (i) Data collection and reporting requirements.
1111
1112 A physician is primarily engaged in the treatment of pain by
1113 prescribing or dispensing controlled substance medications when
1114 the majority of the patients seen are prescribed or dispensed
1115 controlled substance medications for the treatment of chronic
1116 nonmalignant pain. Chronic nonmalignant pain is pain unrelated
1117 to cancer which persists beyond the usual course of the disease
1118 or the injury that is the cause of the pain or more than 90 days
1119 after surgery.
1120 (8)(5) A privately owned clinic, facility, or office that
1121 advertises in any medium for any type of pain-management
1122 services or employs one or more physicians who are primarily
1123 engaged in the treatment of pain by prescribing or dispensing
1124 controlled substances is exempt from the registration provisions
1125 in subsection (3) if the majority of the physicians who provide
1126 services in the clinic, facility, or office primarily provide
1127 surgical services.
1128 Section 11. Paragraph (e) is added to subsection (1) of
1129 section 459.013, Florida Statutes, and paragraph (d) is added to
1130 subsection (2) of that section, to read:
1131 459.013 Penalty for violations.—
1132 (1) Each of the following acts constitutes a felony of the
1133 third degree, punishable as provided in s. 775.082, s. 775.083,
1134 or s. 775.084:
1135 (e) Knowingly operating, owning, or managing a
1136 nonregistered pain-management clinic that is required to be
1137 registered with the Department of Health pursuant to s.
1138 459.005(3).
1139 (2) Each of the following acts constitutes a misdemeanor of
1140 the first degree, punishable as provided in s. 775.082 or s.
1141 775.083:
1142 (d) Knowingly prescribing, dispensing, or causing to be
1143 prescribed or dispensed controlled substances in a nonregistered
1144 pain-management clinic that is required to be registered with
1145 the Department of Health pursuant to s. 459.005(3).
1146 Section 12. Section 459.0137, Florida Statutes, is created
1147 to read:
1148 459.0137 Pain-management clinics.—
1149 (1)(a) An osteopathic physician may not practice
1150 osteopathic medicine in a pain-management clinic that is not
1151 registered with the department as required by s. 459.005(3) Each
1152 location of a pain-management clinic must be registered
1153 separately regardless of whether the clinic is operated under
1154 the same business name or management as another clinic. If a
1155 pain-management clinic fails an annual inspection pursuant to s.
1156 459.005(3), the department may revoke the clinic’s certificate
1157 of registration and prohibit all physicians associated with that
1158 pain-management clinic from practicing at that office location.
1159 A physician who violates this paragraph is subject to review by
1160 his or her appropriate medical regulatory board.
1161 (b) A pain-management clinic may not be owned, in whole or
1162 in part, by or have any contractual relationship, whether
1163 through employment or by independent contract, with:
1164 1. An osteopathic physician who during the course of his or
1165 her practice has been denied the privilege of prescribing,
1166 dispensing, administering, supplying, or selling any controlled
1167 substance and who has, during the course of his or her practice,
1168 or had the board take disciplinary action in this state or any
1169 other state or by the United States against his or her medical
1170 license as a result of violating laws or rules relating to
1171 prescribing or dispensing controlled substances or for his or
1172 her dependency on drugs or alcohol.
1173 2. A person whose application for a license to prescribe,
1174 dispense, or administer a controlled substance has been denied
1175 by any jurisdiction.
1176 3. The holder of a license issued by any jurisdiction which
1177 allowed the owner, employee, or person to prescribe, dispense,
1178 or administer a controlled substance and which has been
1179 restricted or revoked by the issuing jurisdiction.
1180 4. A person who is the subject of a disciplinary proceeding
1181 by any licensing entity for conduct resulting from
1182 inappropriately prescribing, dispensing, or administering a
1183 controlled substance.
1184 5. A person who has been convicted of or pled guilty or
1185 nolo contendere to, regardless of adjudication, an offense that
1186 constitutes a felony or a misdemeanor for receiving illicit and
1187 diverted drugs, including a controlled substance listed in
1188 Schedule I, Schedule II, Schedule III, Schedule IV, or Schedule
1189 V of s. 893.03, in this state, any other state, or the United
1190 States.
1191 (c) If the department finds that a privately owned pain
1192 management clinic is owned, directly or indirectly, by a person
1193 meeting any criteria listed in paragraph (b), the department
1194 shall refuse to register the pain-management clinic or shall
1195 revoke the certificate of registration previously issued by the
1196 department. As determined by rule, the department may grant an
1197 exemption if more than 10 years have elapsed since adjudication.
1198 As used in this subsection, the term “convicted” includes an
1199 adjudication of guilt following a plea of guilty or nolo
1200 contendere or the forfeiture of a bond when charged with a
1201 crime.
1202 (d) The owner, operator, or designated osteopathic
1203 physician of a pain-management clinic shall:
1204 1. Be onsite at the pain-management clinic for at least 33
1205 percent of the operating hours of the pain-management clinic
1206 with exemptions provided by department rule. If this requirement
1207 is not met by a designated physician, the owner or operator
1208 shall be physically present at the pain-management clinic at
1209 least once a week to inspect the facility in accordance with
1210 department rule. Exemptions may be provided by department rule
1211 if the designated osteopathic physician is present weekly and
1212 conducts inspections; and
1213 2. Review on a weekly basis at least 33 percent of the
1214 total number of patient files of the pain-management clinic,
1215 including the patient files in the possession of a pain
1216 management clinic employee or contractor to whom authority for
1217 patient care has been delegated by the pain-management clinic,
1218 with exemptions provided by department rule.
1219 (e) A violation of this subsection is grounds for
1220 disciplinary action against the pain-management clinic, its
1221 owner, its operator or designated osteopathic physician under s.
1222 459.005. An owner or operator who fails to comply with this
1223 subsection commits a misdemeanor of the first degree, punishable
1224 as provided in s. 775.082 or s. 775.083.
1225 (2) A person may not dispense any medication, including a
1226 controlled substance, on the premises of a pain-management
1227 clinic unless he or she is a physician licensed under this
1228 chapter or chapter 458; however, a pharmacist licensed under
1229 chapter 465 may dispense any medication, including a controlled
1230 substance, on the premises of a pain-management clinic.
1231 (3) After a physical examination of the patient the same
1232 day that a controlled substance is dispensed, a physician must
1233 document in the patient’s record the reason for prescribing or
1234 dispensing more than a 72-hour dose of a controlled substance
1235 for the treatment of chronic nonmalignant pain. A physician
1236 shall follow the department’s rules for treating pain when
1237 prescribing the use of controlled substances and dispensing
1238 controlled substances. The failure to follow the department’s
1239 rules is grounds for disciplinary action by the Board of
1240 Osteopathic Medicine and the possible revocation of the clinic’s
1241 certificate of registration by the department.
1242 (4) As used in this section, the term:
1243 (a) “Controlled substance” means a controlled substance
1244 listed in Schedule II, Schedule III, or Schedule IV of s.
1245 893.03.
1246 (b) “Parties affiliated with a pain-management clinic”
1247 means:
1248 1. A director, officer, trustee, partner, or committee
1249 member of a pain-management clinic or applicant, or a subsidiary
1250 or service corporation of the pain-management clinic or
1251 applicant; or
1252 2. A person who, directly or indirectly, manages, controls,
1253 or oversees the operation of a pain-management clinic or
1254 applicant, regardless of whether the person is a partner,
1255 shareholder, manager, member, officer, director, independent
1256 contractor, or employee of the pain-management clinic or
1257 applicant.
1258 (5) On or after January 3, 2011, an application for an
1259 initial or renewal registration of a pain-management clinic must
1260 include:
1261 (a) The name, full business address, and telephone number
1262 of the applicant.
1263 (b) All trade or business names used by the applicant.
1264 (c) The address, telephone numbers, and names of contact
1265 persons for each facility used by the applicant for the
1266 prescribing or dispensing of controlled substance medications in
1267 the treatment of pain.
1268 (d) The type of ownership or operation, such as a
1269 partnership, corporation, or sole proprietorship.
1270 (e) The names of each owner and each operator of the pain
1271 management clinic, including:
1272 1. If an individual, the name of the individual.
1273 2. If a partnership, the name of each partner and the name
1274 of the partnership.
1275 3. If a corporation:
1276 a. The name, address, and title of each corporate officer
1277 and director.
1278 b. The name and address of the corporation and the resident
1279 agent of the corporation, the resident agent’s address, and the
1280 corporation’s state of incorporation.
1281 c. The name and address of each shareholder of the
1282 corporation that owns 5 percent or more of the outstanding stock
1283 of the corporation.
1284 4. If a sole proprietorship, the full name of the sole
1285 proprietor and the name of the business entity.
1286 5. If a limited liability company:
1287 a. The name and address of each member.
1288 b. The name and address of each manager.
1289 c. The name and address of the limited liability company,
1290 the resident agent of the limited liability company, and the
1291 name of the state in which the limited liability company was
1292 organized.
1293 (f) The tax year of the applicant.
1294 (g) A copy of the deed for the property on which the
1295 applicant’s pain-management clinic is located, if the clinic is
1296 owned by the applicant, or a copy of the applicant’s lease for
1297 the property on which the applicant’s pain-management clinic is
1298 located, which must have an original term of not less than 1
1299 calendar year, if the pain-management clinic is not owned by the
1300 applicant.
1301 (h) A list of all licenses and permits issued to the
1302 applicant by any other state which authorize the applicant to
1303 purchase or possess prescription drugs.
1304 (i) The name of the manager of the pain-management clinic
1305 that is applying for the initial or renewal registration, the
1306 next four highest ranking employees responsible for operations
1307 of the pain-management clinic, the name of all parties
1308 affiliated with the pain-management clinic, and the personal
1309 information statement and fingerprints required under subsection
1310 (6) for each person.
1311 (6)(a) Each person required by subsection (5) to provide a
1312 personal information statement and fingerprints shall provide
1313 the following information to the department on forms prescribed
1314 by the department:
1315 1. The person’s places of residence for the past 7 years.
1316 2. The person’s date and place of birth.
1317 3. The person’s occupations, positions of employment, and
1318 offices held during the past 7 years.
1319 4. The principal business and address of any business,
1320 corporation, or other organization in which the person:
1321 a. Held an office during the past 7 years; or
1322 b. Had an occupation or position of employment during the
1323 past 7 years.
1324 5. Whether the person has been, during the past 7 years,
1325 the subject of any proceeding for the revocation of any license
1326 and, if so, the nature of the proceeding and the disposition of
1327 the proceeding.
1328 6. Whether, during the past 7 years, the person has been
1329 enjoined, temporarily or permanently, by a court of competent
1330 jurisdiction from violating any federal or state law regulating
1331 the possession, control, or distribution of controlled
1332 substances, together with details concerning any such event.
1333 7. A description of any involvement by the person during
1334 the past 7 years, including any investments, other than the
1335 ownership of stock in a publicly traded company or mutual fund,
1336 with any business that manufactured, administered, prescribed,
1337 distributed, or stored pharmaceutical products and any lawsuits
1338 in which the businesses were named as a party.
1339 8. A description of any felony criminal offense of which
1340 the person, as an adult, was found guilty, regardless of whether
1341 adjudication of guilt was withheld or whether the person pled
1342 guilty or nolo contendere. A criminal offense committed in
1343 another jurisdiction which would have been a felony in this
1344 state must be reported. If the person indicates that a criminal
1345 conviction is under appeal and submits a copy of the notice of
1346 appeal of that criminal offense, the applicant shall, within 15
1347 days after the disposition of the appeal, submit to the
1348 department a copy of the final written order of disposition.
1349 9. A photograph of the person taken in the previous 30
1350 days.
1351 10. A set of fingerprints from the person on a form and
1352 under procedures specified by the department and payment of a
1353 fee equal to the cost incurred by the department for the
1354 criminal history record check of the person.
1355 11. The name, address, occupation, and date and place of
1356 birth for each member of the person’s immediate family who is 18
1357 years of age or older. As used in this subparagraph, the term
1358 “member of the person’s immediate family” includes the person’s
1359 spouse, children, parents, siblings, the spouses of the person’s
1360 children, and the spouses of the person’s siblings.
1361 12. Any other relevant information that the department
1362 requires.
1363 (b) The information required under paragraph (a) shall be
1364 provided under oath.
1365 (c)1. The department shall submit the fingerprints provided
1366 with an application for initial registration to the Department
1367 of Law Enforcement for a statewide criminal record check and for
1368 forwarding to the Federal Bureau of Investigation for a national
1369 criminal record check.
1370 2. For the renewal of a registration on or after January 3,
1371 2011, the department shall submit the fingerprints provided as a
1372 part of a renewal application and background check of registered
1373 persons to the Department of Law Enforcement for a statewide
1374 criminal record check, and for forwarding to the Federal Bureau
1375 of Investigation for a national criminal record check. For any
1376 subsequent renewal of a registration, the department shall
1377 submit the required information for a statewide and national
1378 criminal record check.
1379 3. Any person who submits to the department a set of
1380 fingerprints for a criminal record check is not required to
1381 provide a subsequent set of fingerprints for a criminal record
1382 check if the person has undergone a criminal record check with
1383 submission of fingerprints for background screening as a
1384 condition of the issuance of an initial registration or the
1385 renewal of a registration on or after January 4, 2011.
1386 4. The department shall submit fingerprints for those
1387 undergoing a background screening and they must be submitted
1388 electronically. The department shall screen background results
1389 to determine if an applicant meets registration requirements.
1390 5. The cost for the processing fingerprints for an initial
1391 or renewal registration must be borne by the person subject to
1392 the background check. The Department of Law Enforcement shall
1393 receive payment for processing the fingerprints submitted to it
1394 each month by invoice to the Department of Health or by credit
1395 card from the applicant or a vendor acting on behalf of the
1396 applicant.
1397 6. All fingerprints submitted to the Department of Law
1398 Enforcement shall be retained by the Department of Law
1399 Enforcement in a manner provided by rule and entered into the
1400 statewide automated fingerprint identification system authorized
1401 by s. 943.05(2)(b). The fingerprints shall thereafter be
1402 available for all purposes and uses authorized for arrest
1403 fingerprint cards entered in the statewide automated fingerprint
1404 identification system pursuant to s. 943.051.
1405 7. Fingerprints for arrests submitted or received under s.
1406 943.051 shall be searched against the fingerprints retained in
1407 the statewide automated fingerprint identification system. Any
1408 arrest record that is identified with the retained fingerprints
1409 of a person subject to the background screening under this
1410 section shall be reported to the department.
1411 8. Each person shall pay to the department a fee for the
1412 cost of retaining the fingerprints and performing the ongoing
1413 searches of arrest records. The Department of Law Enforcement
1414 shall receive payment for processing and retaining the
1415 fingerprints submitted to it each month by invoice to the
1416 Department of Health or by credit card from the applicant or a
1417 vendor acting on behalf of the applicant.
1418 9. The Department of Law Enforcement shall adopt rules
1419 establishing the amount of the fee and procedures for retaining
1420 the fingerprints, performing the searches, and disseminating the
1421 search results. The department shall notify the Department of
1422 Law Enforcement of any change in a person’s status as a person
1423 listed in s. 458.3265 if, as a result of the change, the
1424 person’s fingerprints are no longer required to be retained
1425 under paragraph (a).
1426 (7) The State Surgeon General shall order a clinic closed
1427 for operations if closure is warranted following failure of the
1428 owner or operator of the clinic to pass a background check of
1429 his or her criminal history. As determined by rule, the
1430 department may grant an exemption if more than 10 years have
1431 elapsed since adjudication.
1432 (8) By January 3, 2011, the department and the Department
1433 of Law Enforcement shall adopt rules pursuant to ss. 120.536(1)
1434 and 120.54 to administer the provisions of this section, which
1435 shall include, as necessary, the reporting, management,
1436 development, and implementation of the fingerprint requirements
1437 in this section.
1438 Section 13. This act shall take effect July 1, 2010.