Florida Senate - 2012 SENATOR AMENDMENT
Bill No. CS/CS/HB 1175, 1st Eng.
Barcode 848474
LEGISLATIVE ACTION
Senate . House
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Floor: 1/RE/3R .
03/07/2012 12:04 PM .
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Senator Bogdanoff moved the following:
1 Senate Amendment (with title amendment)
2
3 Between lines 20 and 21
4 insert:
5 Section 1. Section 456.44, Florida Statutes, is amended to
6 read:
7 456.44 Controlled substance prescribing.—
8 (1) DEFINITIONS.—
9 (a) “Addiction medicine specialist” means a board-certified
10 psychiatrist who holds physiatrist with a subspecialty
11 certification in addiction medicine or who is eligible for such
12 subspecialty certification in addiction medicine, a an addiction
13 medicine physician who is certified or eligible for
14 certification by the American Board Society of Addiction
15 Medicine, or an osteopathic physician who holds a certificate of
16 added qualification in Addiction Medicine through the American
17 Osteopathic Association.
18 (b) “Adverse incident” means any incident set forth in s.
19 458.351(4)(a)-(e) or s. 459.026(4)(a)-(e).
20 (c) “Board–certified pain management physician” means a
21 physician who possesses board certification in pain medicine by
22 the American Board of Pain Medicine, board certification by the
23 American Board of Interventional Pain Physicians, or board
24 certification or subcertification in pain management or pain
25 medicine by a specialty board recognized by the American
26 Association of Physician Specialists or the American Board of
27 Medical Specialties or an osteopathic physician who holds a
28 certificate in Pain Management by the American Osteopathic
29 Association.
30 (d) “Chronic nonmalignant pain” means pain unrelated to
31 cancer, or rheumatoid arthritis, or sickle cell anemia which
32 persists beyond the usual course of disease or beyond the injury
33 that is the cause of the pain or which persists more than 90
34 days after surgery.
35 (e) “Mental health addiction facility” means a facility
36 licensed under chapter 394 or chapter 397.
37 (2) REGISTRATION.—Effective January 1, 2012, a physician
38 licensed under chapter 458, chapter 459, chapter 461, or chapter
39 466 who prescribes any controlled substance listed in Schedule
40 II, Schedule III, or Schedule IV, as defined in s. 893.03, over
41 a 6-month period to any one patient for the treatment of chronic
42 nonmalignant pain, must:
43 (a) Designate himself or herself as a controlled substance
44 prescribing practitioner on the physician’s practitioner
45 profile.
46 (b) Comply with the requirements of this section and
47 applicable board rules.
48 (3) STANDARDS OF PRACTICE.—The standards of practice in
49 this section do not supersede the level of care, skill, and
50 treatment recognized in general law related to health care
51 licensure.
52 (a) A complete medical history and a physical examination
53 must be conducted before beginning any treatment and must be
54 documented in the medical record. The exact components of the
55 physical examination shall be left to the judgment of the
56 clinician who is expected to perform a physical examination
57 proportionate to the diagnosis that justifies a treatment. The
58 medical record must, at a minimum, document the nature and
59 intensity of the pain, current and past treatments for pain,
60 underlying or coexisting diseases or conditions, the effect of
61 the pain on physical and psychological function, a review of
62 previous medical records, previous diagnostic studies, and
63 history of alcohol and substance abuse. The medical record must
64 shall also document the presence of one or more recognized
65 medical indications for the use of a controlled substance. Each
66 registrant must develop a written plan for assessing each
67 patient’s risk of aberrant drug-related behavior, which may
68 include patient drug testing. Registrants must assess each
69 patient’s risk for aberrant drug-related behavior and monitor
70 that risk on an ongoing basis in accordance with the plan.
71 (b) Each registrant must develop a written individualized
72 treatment plan for each patient. The treatment plan must shall
73 state objectives that will be used to determine treatment
74 success, such as pain relief and improved physical and
75 psychosocial function, and must shall indicate if any further
76 diagnostic evaluations or other treatments are planned. After
77 treatment begins, the physician shall adjust drug therapy to the
78 individual medical needs of each patient. Other treatment
79 modalities, including a rehabilitation program, shall be
80 considered depending on the etiology of the pain and the extent
81 to which the pain is associated with physical and psychosocial
82 impairment. The interdisciplinary nature of the treatment plan
83 shall be documented.
84 (c) The physician shall discuss the risks and benefits of
85 the use of controlled substances, including the risks of abuse
86 and addiction, as well as physical dependence and its
87 consequences, with the patient, persons designated by the
88 patient, or the patient’s surrogate or guardian if the patient
89 is incompetent. The physician shall use a written controlled
90 substance agreement between the physician and the patient
91 outlining the patient’s responsibilities, including, but not
92 limited to:
93 1. Number and frequency of prescriptions and refills for
94 controlled substances substance prescriptions and refills.
95 2. Patient compliance and reasons for which drug therapy
96 may be discontinued, such as a violation of the agreement.
97 3. An agreement that controlled substances for the
98 treatment of chronic nonmalignant pain shall be prescribed by a
99 single treating physician unless otherwise authorized by the
100 treating physician and documented in the medical record.
101 (d) The patient shall be seen by the physician at regular
102 intervals, not to exceed 3 months, to assess the efficacy of
103 treatment, ensure that controlled-substance controlled substance
104 therapy remains indicated, evaluate the patient’s progress
105 toward treatment objectives, consider adverse drug effects, and
106 review the etiology of the pain. Continuation or modification of
107 therapy depends shall depend on the physician’s evaluation of
108 the patient’s progress. If treatment goals are not being
109 achieved, despite medication adjustments, the physician shall
110 reevaluate the appropriateness of continued treatment. The
111 physician shall monitor patient compliance in medication usage,
112 related treatment plans, controlled substance agreements, and
113 indications of substance abuse or diversion at a minimum of 3
114 month intervals.
115 (e) The physician shall refer the patient as necessary for
116 additional evaluation and treatment in order to achieve
117 treatment objectives. Special attention shall be given to those
118 patients who are at risk for misusing their medications and
119 those whose living arrangements pose a risk for medication
120 misuse or diversion. The management of pain in patients with a
121 history of substance abuse or with a comorbid psychiatric
122 disorder requires extra care, monitoring, and documentation and
123 requires consultation with or referral to an addiction medicine
124 specialist addictionologist or psychiatrist physiatrist.
125 (f) A physician registered under this section must maintain
126 accurate, current, and complete records that are accessible and
127 readily available for review and comply with the requirements of
128 this section, the applicable practice act, and applicable board
129 rules. The medical records must include, but are not limited to:
130 1. The complete medical history and a physical examination,
131 including history of drug abuse or dependence.
132 2. Diagnostic, therapeutic, and laboratory results.
133 3. Evaluations and consultations.
134 4. Treatment objectives.
135 5. Discussion of risks and benefits.
136 6. Treatments.
137 7. Medications, including date, type, dosage, and quantity
138 prescribed.
139 8. Instructions and agreements.
140 9. Periodic reviews.
141 10. Results of any drug testing.
142 11. A photocopy of the patient’s government-issued photo
143 identification.
144 12. If a written prescription for a controlled substance is
145 given to the patient, a duplicate of the prescription.
146 13. The physician’s full name presented in a legible
147 manner.
148 (g) Patients with signs or symptoms of substance abuse
149 shall be immediately referred to a board-certified pain
150 management physician, an addiction medicine specialist, or a
151 mental health addiction facility as it pertains to drug abuse or
152 addiction unless the physician is board eligible or board
153 certified board-certified or board-eligible in pain management.
154 Throughout the period of time before receiving the consultant’s
155 report, a prescribing physician shall clearly and completely
156 document medical justification for continued treatment with
157 controlled substances and those steps taken to ensure medically
158 appropriate use of controlled substances by the patient. Upon
159 receipt of the consultant’s written report, the prescribing
160 physician shall incorporate the consultant’s recommendations for
161 continuing, modifying, or discontinuing the controlled-substance
162 controlled substance therapy. The resulting changes in treatment
163 shall be specifically documented in the patient’s medical
164 record. Evidence or behavioral indications of diversion shall be
165 followed by discontinuation of the controlled-substance
166 controlled substance therapy, and the patient shall be
167 discharged, and all results of testing and actions taken by the
168 physician shall be documented in the patient’s medical record.
169 (h) When a pharmacy subject to this section receives a
170 prescription, the prescription is deemed compliant with the
171 standards of practice under this section and, therefore, valid
172 for dispensing.
173
174 This subsection does not apply to a board-eligible or board
175 certified anesthesiologist, physiatrist, psychiatrist,
176 rheumatologist, or neurologist, or to a board-certified
177 physician who has surgical privileges at a hospital or
178 ambulatory surgery center and primarily provides surgical
179 services. This subsection does not apply to a board-eligible or
180 board-certified medical specialist who has also completed a
181 fellowship in pain medicine approved by the Accreditation
182 Council for Graduate Medical Education or the American
183 Osteopathic Association, or who is board eligible or board
184 certified in pain medicine by a board approved by the American
185 Board of Pain Medicine, the American Board of Medical
186 Specialties, or the American Osteopathic Association and
187 performs interventional pain procedures of the type routinely
188 billed using surgical codes. This subsection does not apply to a
189 physician certified by the American Board of Medical Specialties
190 in hospice and palliative medicine or to an osteopathic
191 physician who holds a certificate of added qualification in
192 hospice and palliative medicine through the American Osteopathic
193 Association. This subsection does not apply to a physician who
194 prescribes medically necessary controlled substances for a
195 patient during an inpatient stay or while providing emergency
196 services and care in a hospital licensed under chapter 395. This
197 subsection does not apply to a physician who treats a patient
198 who is admitted in a nursing home or related health care
199 facility or receiving hospice services as defined in chapter
200 400. This subsection does not apply to a physician who treats a
201 patient in accordance with an approved clinical trial. This
202 subsection does not apply to a physician licensed under chapter
203 458 or chapter 459 who writes fewer than 50 prescriptions for a
204 controlled substance for all of his or her patients combined in
205 any one calendar year.
206 Section 2. Paragraph (a) of subsection (1) of section
207 458.3265, Florida Statutes, is amended to read:
208 458.3265 Pain-management clinics.—
209 (1) REGISTRATION.—
210 (a)1. As used in this section, the term:
211 a. “Chronic nonmalignant pain” means pain unrelated to
212 cancer, or rheumatoid arthritis, or sickle cell anemia which
213 persists beyond the usual course of disease or beyond the injury
214 that is the cause of the pain or which persists more than 90
215 days after surgery.
216 b. “Pain-management clinic” or “clinic” means any publicly
217 or privately owned facility:
218 (I) That advertises in any medium for any type of pain
219 management services; or
220 (II) Where in any month a majority of patients are
221 prescribed opioids, benzodiazepines, barbiturates, or
222 carisoprodol for the treatment of chronic nonmalignant pain.
223 2. Each pain-management clinic must register with the
224 department unless:
225 a. The That clinic is licensed as a facility pursuant to
226 chapter 395;
227 b. The majority of the physicians who provide services in
228 the clinic primarily provide primarily surgical services;
229 c. The clinic is owned by a publicly held corporation whose
230 shares are traded on a national exchange or on the over-the
231 counter market and whose total assets at the end of the
232 corporation’s most recent fiscal quarter exceeded $50 million;
233 d. The clinic is affiliated with an accredited medical
234 school at which training is provided for medical students,
235 residents, or fellows;
236 e. The clinic does not prescribe controlled substances for
237 the treatment of pain;
238 f. The clinic is owned by a corporate entity exempt from
239 federal taxation under 26 U.S.C. s. 501(c)(3);
240 g. The clinic is wholly owned and operated by one or more
241 board-eligible or board-certified anesthesiologists,
242 physiatrists, psychiatrists, rheumatologists, or neurologists;
243 or
244 h. The clinic is wholly owned and operated by one or more
245 board-eligible or board-certified medical specialists who have
246 also completed fellowships in pain medicine approved by the
247 Accreditation Council for Graduate Medical Education, or who are
248 also board eligible or board certified board-certified in pain
249 medicine by a board approved by the American Board of Pain
250 Medicine or the American Board of Medical Specialties and
251 perform interventional pain procedures of the type routinely
252 billed using surgical codes;.
253 i. The clinic is organized as a physician-owned group
254 practice as defined in 42 C.F.R. s. 411.352; or
255 j. Before June 1, 2011, the clinic was wholly owned by
256 physicians who are not board eligible or board certified but who
257 successfully completed a residency program in anesthesiology,
258 psychiatry, rheumatology, or neurology and who have 7 years of
259 documented, full-time practice in pain medicine in this state.
260 For purposes of this paragraph, the term “full-time” is defined
261 as practicing an average of 20 hours per week each year in pain
262 medicine.
263 Section 3. Paragraph (a) of subsection (1) of section
264 459.0137, Florida Statutes, is amended to read:
265 459.0137 Pain-management clinics.—
266 (1) REGISTRATION.—
267 (a)1. As used in this section, the term:
268 a. “Chronic nonmalignant pain” means pain unrelated to
269 cancer, or rheumatoid arthritis, or sickle cell anemia which
270 persists beyond the usual course of disease or beyond the injury
271 that is the cause of the pain or which persists more than 90
272 days after surgery.
273 b. “Pain-management clinic” or “clinic” means any publicly
274 or privately owned facility:
275 (I) That advertises in any medium for any type of pain
276 management services; or
277 (II) Where in any month a majority of patients are
278 prescribed opioids, benzodiazepines, barbiturates, or
279 carisoprodol for the treatment of chronic nonmalignant pain.
280 2. Each pain-management clinic must register with the
281 department unless:
282 a. The That clinic is licensed as a facility pursuant to
283 chapter 395;
284 b. The majority of the physicians who provide services in
285 the clinic primarily provide primarily surgical services;
286 c. The clinic is owned by a publicly held corporation whose
287 shares are traded on a national exchange or on the over-the
288 counter market and whose total assets at the end of the
289 corporation’s most recent fiscal quarter exceeded $50 million;
290 d. The clinic is affiliated with an accredited medical
291 school at which training is provided for medical students,
292 residents, or fellows;
293 e. The clinic does not prescribe controlled substances for
294 the treatment of pain;
295 f. The clinic is owned by a corporate entity exempt from
296 federal taxation under 26 U.S.C. s. 501(c)(3);
297 g. The clinic is wholly owned and operated by one or more
298 board-eligible or board-certified anesthesiologists,
299 physiatrists, psychiatrists, rheumatologists, or neurologists;
300 or
301 h. The clinic is wholly owned and operated by one or more
302 board-eligible or board-certified medical specialists who have
303 also completed fellowships in pain medicine approved by the
304 Accreditation Council for Graduate Medical Education or the
305 American Osteopathic Association, or who are also board eligible
306 or board certified board-certified in pain medicine by a board
307 approved by the American Board of Medical Specialties, the
308 American Association of Physician Specialties, or the American
309 Osteopathic Association and perform interventional pain
310 procedures of the type routinely billed using surgical codes.
311 Section 4. Paragraph (b) of subsection (1) of section
312 465.0276, Florida Statutes, is amended to read:
313 465.0276 Dispensing practitioner.—
314 (1)
315 (b) A practitioner registered under this section may not
316 dispense a controlled substance listed in Schedule II or
317 Schedule III as provided in s. 893.03. This paragraph does not
318 apply to:
319 1. The dispensing of complimentary packages of medicinal
320 drugs which are labeled as a drug sample or complimentary drug
321 as defined in s. 499.028 to the practitioner’s own patients in
322 the regular course of her or his practice without the payment of
323 a fee or remuneration of any kind, whether direct or indirect,
324 as provided in subsection (5).
325 2. The dispensing of controlled substances in the health
326 care system of the Department of Corrections.
327 3. The dispensing of a controlled substance listed in
328 Schedule II or Schedule III in connection with the performance
329 of a surgical procedure. The amount dispensed pursuant to the
330 subparagraph may not exceed a 14-day supply. This exception does
331 not allow for the dispensing of a controlled substance listed in
332 Schedule II or Schedule III more than 14 days after the
333 performance of the surgical procedure. For purposes of this
334 subparagraph, the term “surgical procedure” means any procedure
335 in any setting which involves, or reasonably should involve:
336 a. Perioperative medication and sedation that allows the
337 patient to tolerate unpleasant procedures while maintaining
338 adequate cardiorespiratory function and the ability to respond
339 purposefully to verbal or tactile stimulation and makes intra-
340 and postoperative monitoring necessary; or
341 b. The use of general anesthesia or major conduction
342 anesthesia and preoperative sedation.
343 4. The dispensing of a controlled substance listed in
344 Schedule II or Schedule III pursuant to an approved clinical
345 trial. For purposes of this subparagraph, the term “approved
346 clinical trial” means a clinical research study or clinical
347 investigation that, in whole or in part, is state or federally
348 funded or is conducted under protocols approved an
349 investigational new drug application that is reviewed by the
350 United States Food and Drug Administration.
351 5. The dispensing of methadone in a facility licensed under
352 s. 397.427 where medication-assisted treatment for opiate
353 addiction is provided.
354 6. The dispensing of a controlled substance listed in
355 Schedule II or Schedule III to a patient of a facility licensed
356 under part IV of chapter 400.
357 Section 5. Paragraph (b) of subsection (5) and paragraph
358 (b) of subsection (7) of section 893.055, Florida Statutes, are
359 amended to read:
360 893.055 Prescription drug monitoring program.—
361 (5) When the following acts of dispensing or administering
362 occur, the following are exempt from reporting under this
363 section for that specific act of dispensing or administration:
364 (b) A pharmacist or health care practitioner when
365 administering a controlled substance to a patient who is
366 receiving hospice care or to a patient or resident receiving
367 care as a patient at a hospital, nursing home, ambulatory
368 surgical center, hospice, or intermediate care facility for the
369 developmentally disabled which is licensed in this state.
370 (7)
371 (b) A pharmacy, prescriber, or dispenser shall have access
372 to information in the prescription drug monitoring program’s
373 database which relates to a patient, or a potential patient, of
374 that pharmacy, prescriber, or dispenser in a manner established
375 by the department as needed for the purpose of reviewing the
376 patient’s controlled substance prescription history. Other
377 access to the program’s database shall be limited to the
378 program’s manager and to the designated program and support
379 staff, who may act only at the direction of the program manager
380 or, in the absence of the program manager, as authorized. Access
381 by the program manager or such designated staff is for
382 prescription drug program management only or for management of
383 the program’s database and its system in support of the
384 requirements of this section and in furtherance of the
385 prescription drug monitoring program. Confidential and exempt
386 information in the database shall be released only as provided
387 in paragraph (c) and s. 893.0551. The program manager,
388 designated program and support staff who act at the direction of
389 or in the absence of the program manager, and any individual who
390 has similar access regarding the management of the database from
391 the prescription drug monitoring program shall submit
392 fingerprints to the department for background screening. The
393 department shall follow the procedure established by the
394 Department of Law Enforcement to request a statewide criminal
395 history record check and to request that the Department of Law
396 Enforcement forward the fingerprints to the Federal Bureau of
397 Investigation for a national criminal history record check.
398
399 ================= T I T L E A M E N D M E N T ================
400 And the title is amended as follows:
401 Delete line 2
402 and insert:
403 An act relating to controlled substances; amending s.
404 456.44, F.S.; revising the definition of the term
405 “addiction medicine specialist” to include a board
406 certified psychiatrist, rather than a physiatrist;
407 redefining the term “board-certified pain management
408 physician” to include a physician who possesses board
409 certification or subcertification in pain management
410 by a specialty board recognized by the American Board
411 of Medical Specialties; redefining the term “chronic
412 nonmalignant pain”; providing requirements that a
413 physician who prescribes certain specific controlled
414 substances for the treatment of chronic nonmalignant
415 pain must fulfill; providing that the management of
416 pain in certain patients requires consultation with or
417 referral to a psychiatrist, rather than a physiatrist;
418 providing that a prescription is deemed compliant with
419 the standards of practice and is valid for dispensing
420 when a pharmacy receives it; providing that the
421 standards of practice regarding the prescribing of
422 controlled substances do not apply to certain
423 physicians; amending s. 458.3265, F.S.; revising the
424 definition of the term “chronic nonmalignant pain”;
425 requiring that a pain-management clinic register with
426 the Department of Health unless the clinic is wholly
427 owned by certain board-eligible or board-certified
428 physicians or medical specialists, organized as a
429 physician-owned group practice, or wholly owned by
430 physicians who are not board eligible or board
431 certified but who have completed specified residency
432 programs and have a specified number of years of full
433 time practice in pain medicine; amending s. 459.0137,
434 F.S.; revising the definition of “chronic nonmalginant
435 pain”; requiring that a pain-management clinic
436 register with the Department of Health unless the
437 clinic is wholly owned by certain health care
438 practitioners; amending s. 465.0276, F.S.; redefining
439 the term “approved clinical trial” as it relates to
440 the Florida Pharmacy Act; amending s. 893.055, F.S.;
441 providing that a pharmacist or health care
442 practitioner is exempt from reporting a dispensed
443 controlled substance to the Department of Health when
444 administering the controlled substance to a patient
445 who is receiving hospice care or to a patient or
446 resident receiving care at certain medical facilities
447 licensed in the state; requiring that a pharmacy,
448 prescriber, or dispenser have access to information in
449 the prescription drug monitoring program’s database
450 which relates to a patient, or a potential patient, of
451 that pharmacy, prescriber, or dispenser for the
452 purpose of reviewing the patient’s controlled
453 substance prescription history; amending s.