Bill Text: FL S1198 | 2012 | Regular Session | Comm Sub
Bill Title: Prescribing of Controlled Substances
Spectrum: Bipartisan Bill
Status: (Failed) 2012-03-09 - Died in Criminal Justice, companion bill(s) passed, see CS/CS/HB 787 (Ch. [S1198 Detail]
Download: Florida-2012-S1198-Comm_Sub.html
Florida Senate - 2012 CS for SB 1198
By the Committee on Health Regulation; and Senator Bogdanoff
588-02713A-12 20121198c1
1 A bill to be entitled
2 An act relating to the prescribing of controlled
3 substances; amending s. 456.44, F.S.; revising the
4 definition of the term “addiction medicine specialist”
5 to include a board-certified psychiatrist, rather than
6 a physiatrist; redefining the term “board-certified
7 pain management physician” to include a physician who
8 possesses board certification or subcertification in
9 pain management by a specialty board recognized by the
10 American Board of Medical Specialties; redefining the
11 term “chronic nonmalignant pain”; providing
12 requirements that a physician who prescribes certain
13 specific controlled substances for the treatment of
14 chronic nonmalignant pain must fulfill; providing that
15 the management of pain in certain patients requires
16 consultation with or referral to a psychiatrist,
17 rather than a physiatrist; providing that a
18 prescription is deemed compliant with the standards of
19 practice and is valid for dispensing when a pharmacy
20 receives it; providing that the standards of practice
21 regarding the prescribing of controlled substances do
22 not apply to certain physicians; amending s. 458.3265,
23 F.S.; revising the definition of the term “chronic
24 nonmalignant pain”; requiring that a pain-management
25 clinic register with the Department of Health unless
26 the clinic is wholly owned by certain board-eligible
27 or board-certified physicians or medical specialists,
28 organized as a physician-owned group practice, or
29 wholly owned by physicians who are not board eligible
30 or board certified but who have completed specified
31 residency programs and have a specified number of
32 years of full-time practice in pain medicine; amending
33 s. 459.0137, F.S.; revising the definition of “chronic
34 nonmalginant pain”; requiring that a pain-management
35 clinic register with the Department of Health unless
36 the clinic is wholly owned by certain health care
37 practitioners; amending s. 465.0276, F.S.; redefining
38 the term “approved clinical trial” as it relates to
39 the Florida Pharmacy Act; amending s. 893.055, F.S.;
40 providing that a pharmacist or health care
41 practitioner is exempt from reporting a dispensed
42 controlled substance to the Department of Health when
43 administering the controlled substance to a patient
44 who is receiving hospice care or to a patient or
45 resident receiving care at certain medical facilities
46 licensed in the state; requiring that a pharmacy,
47 prescriber, or dispenser have access to information in
48 the prescription drug monitoring program’s database
49 which relates to a patient, or a potential patient, of
50 that pharmacy, prescriber, or dispenser for the
51 purpose of reviewing the patient’s controlled
52 substance prescription history; providing an effective
53 date.
54
55 Be It Enacted by the Legislature of the State of Florida:
56
57 Section 1. Section 456.44, Florida Statutes, is amended to
58 read:
59 456.44 Controlled substance prescribing.—
60 (1) DEFINITIONS.—
61 (a) “Addiction medicine specialist” means a board-certified
62 psychiatrist who holds physiatrist with a subspecialty
63 certification in addiction medicine or who is eligible for such
64 subspecialty certification in addiction medicine, a an addiction
65 medicine physician who is certified or eligible for
66 certification by the American Society of Addiction Medicine, or
67 an osteopathic physician who holds a certificate of added
68 qualification in Addiction Medicine through the American
69 Osteopathic Association.
70 (b) “Adverse incident” means any incident set forth in s.
71 458.351(4)(a)-(e) or s. 459.026(4)(a)-(e).
72 (c) “Board–certified pain management physician” means a
73 physician who possesses board certification in pain medicine by
74 the American Board of Pain Medicine, board certification by the
75 American Board of Interventional Pain Physicians, or board
76 certification or subcertification in pain management by a
77 specialty board recognized by the American Association of
78 Physician Specialists or the American Board of Medical
79 Specialties or an osteopathic physician who holds a certificate
80 in Pain Management by the American Osteopathic Association.
81 (d) “Chronic nonmalignant pain” means pain unrelated to
82 cancer, or rheumatoid arthritis, or sickle cell anemia which
83 persists beyond the usual course of disease or beyond the injury
84 that is the cause of the pain or which persists more than 90
85 days after surgery.
86 (e) “Mental health addiction facility” means a facility
87 licensed under chapter 394 or chapter 397.
88 (2) REGISTRATION.—Effective January 1, 2012, a physician
89 licensed under chapter 458, chapter 459, chapter 461, or chapter
90 466 who prescribes any controlled substance listed in Schedule
91 II, Schedule III, or Schedule IV of as defined in s. 893.03, for
92 the treatment of chronic nonmalignant pain, must:
93 (a) Designate himself or herself as a controlled substance
94 prescribing practitioner on the physician’s practitioner
95 profile.
96 (b) Comply with the requirements of this section and
97 applicable board rules.
98 (3) STANDARDS OF PRACTICE.—The standards of practice in
99 this section do not supersede the level of care, skill, and
100 treatment recognized in general law related to health care
101 licensure.
102 (a) A complete medical history and a physical examination
103 must be conducted before beginning any treatment and must be
104 documented in the medical record. The exact components of the
105 physical examination shall be left to the judgment of the
106 clinician who is expected to perform a physical examination
107 proportionate to the diagnosis that justifies a treatment. The
108 medical record must, at a minimum, document the nature and
109 intensity of the pain, current and past treatments for pain,
110 underlying or coexisting diseases or conditions, the effect of
111 the pain on physical and psychological function, a review of
112 previous medical records, previous diagnostic studies, and
113 history of alcohol and substance abuse. The medical record must
114 shall also document the presence of one or more recognized
115 medical indications for the use of a controlled substance. Each
116 registrant must develop a written plan for assessing each
117 patient’s risk of aberrant drug-related behavior, which may
118 include patient drug testing. Registrants must assess each
119 patient’s risk for aberrant drug-related behavior and monitor
120 that risk on an ongoing basis in accordance with the plan.
121 (b) Each registrant must develop a written individualized
122 treatment plan for each patient. The treatment plan must shall
123 state objectives that will be used to determine treatment
124 success, such as pain relief and improved physical and
125 psychosocial function, and must shall indicate if any further
126 diagnostic evaluations or other treatments are planned. After
127 treatment begins, the physician shall adjust drug therapy to the
128 individual medical needs of each patient. Other treatment
129 modalities, including a rehabilitation program, shall be
130 considered depending on the etiology of the pain and the extent
131 to which the pain is associated with physical and psychosocial
132 impairment. The interdisciplinary nature of the treatment plan
133 shall be documented.
134 (c) The physician shall discuss the risks and benefits of
135 the use of controlled substances, including the risks of abuse
136 and addiction, as well as physical dependence and its
137 consequences, with the patient, persons designated by the
138 patient, or the patient’s surrogate or guardian if the patient
139 is incompetent. The physician shall use a written controlled
140 substance agreement between the physician and the patient
141 outlining the patient’s responsibilities, including, but not
142 limited to:
143 1. Number and frequency of prescriptions and refills for
144 controlled substances substance prescriptions and refills.
145 2. Patient compliance and reasons for which drug therapy
146 may be discontinued, such as a violation of the agreement.
147 3. An agreement that controlled substances for the
148 treatment of chronic nonmalignant pain shall be prescribed by a
149 single treating physician unless otherwise authorized by the
150 treating physician and documented in the medical record.
151 (d) The patient shall be seen by the physician at regular
152 intervals, not to exceed 3 months, to assess the efficacy of
153 treatment, ensure that controlled-substance controlled substance
154 therapy remains indicated, evaluate the patient’s progress
155 toward treatment objectives, consider adverse drug effects, and
156 review the etiology of the pain. Continuation or modification of
157 therapy depends shall depend on the physician’s evaluation of
158 the patient’s progress. If treatment goals are not being
159 achieved, despite medication adjustments, the physician shall
160 reevaluate the appropriateness of continued treatment. The
161 physician shall monitor patient compliance in medication usage,
162 related treatment plans, controlled substance agreements, and
163 indications of substance abuse or diversion at a minimum of 3
164 month intervals.
165 (e) The physician shall refer the patient as necessary for
166 additional evaluation and treatment in order to achieve
167 treatment objectives. Special attention shall be given to those
168 patients who are at risk for misusing their medications and
169 those whose living arrangements pose a risk for medication
170 misuse or diversion. The management of pain in patients with a
171 history of substance abuse or with a comorbid psychiatric
172 disorder requires extra care, monitoring, and documentation and
173 requires consultation with or referral to an addictionologist or
174 psychiatrist physiatrist.
175 (f) A physician registered under this section must maintain
176 accurate, current, and complete records that are accessible and
177 readily available for review and comply with the requirements of
178 this section, the applicable practice act, and applicable board
179 rules. The medical records must include, but are not limited to:
180 1. The complete medical history and a physical examination,
181 including history of drug abuse or dependence.
182 2. Diagnostic, therapeutic, and laboratory results.
183 3. Evaluations and consultations.
184 4. Treatment objectives.
185 5. Discussion of risks and benefits.
186 6. Treatments.
187 7. Medications, including date, type, dosage, and quantity
188 prescribed.
189 8. Instructions and agreements.
190 9. Periodic reviews.
191 10. Results of any drug testing.
192 11. A photocopy of the patient’s government-issued photo
193 identification.
194 12. If a written prescription for a controlled substance is
195 given to the patient, a duplicate of the prescription.
196 13. The physician’s full name presented in a legible
197 manner.
198 (g) Patients with signs or symptoms of substance abuse
199 shall be immediately referred to a board-certified pain
200 management physician, an addiction medicine specialist, or a
201 mental health addiction facility as it pertains to drug abuse or
202 addiction unless the physician is board-certified or board
203 eligible in pain management. Throughout the period of time
204 before receiving the consultant’s report, a prescribing
205 physician shall clearly and completely document medical
206 justification for continued treatment with controlled substances
207 and those steps taken to ensure medically appropriate use of
208 controlled substances by the patient. Upon receipt of the
209 consultant’s written report, the prescribing physician shall
210 incorporate the consultant’s recommendations for continuing,
211 modifying, or discontinuing the controlled-substance controlled
212 substance therapy. The resulting changes in treatment shall be
213 specifically documented in the patient’s medical record.
214 Evidence or behavioral indications of diversion shall be
215 followed by discontinuation of the controlled-substance
216 controlled substance therapy, and the patient shall be
217 discharged, and all results of testing and actions taken by the
218 physician shall be documented in the patient’s medical record.
219 (h) When a pharmacy subject to this section receives a
220 prescription, the prescription is deemed compliant with the
221 standards of practice under this section and, therefore, valid
222 for dispensing.
223
224 This subsection does not apply to a board-eligible or board
225 certified anesthesiologist, physiatrist, psychiatrist,
226 rheumatologist, or neurologist, or to a board-certified
227 physician who has surgical privileges at a hospital or
228 ambulatory surgery center and primarily provides surgical
229 services. This subsection does not apply to a board-eligible or
230 board-certified medical specialist who has also completed a
231 fellowship in pain medicine approved by the Accreditation
232 Council for Graduate Medical Education or the American
233 Osteopathic Association, or who is board-eligible or board
234 certified in pain medicine by a board approved by the American
235 Board of Pain Medicine, the American Board of Medical
236 Specialties, or the American Osteopathic Association and
237 performs interventional pain procedures of the type routinely
238 billed using surgical codes. This subsection does not apply to a
239 physician certified by the American Board of Medical Specialties
240 in hospice and palliative medicine or to an osteopathic
241 physician who holds a certificate of added qualification in
242 hospice and palliative medicine through the American Osteopathic
243 Association. This subsection does not apply to hospitalists or
244 other physicians who prescribe medically necessary controlled
245 substances for a patient during an inpatient stay or while
246 providing emergency services and care in a hospital licensed
247 under chapter 395. This subsection does not apply to a physician
248 who is treating a patient in accordance with an approved
249 clinical trial.
250 Section 2. Paragraph (a) of subsection (1) of section
251 458.3265, Florida Statutes, is amended to read:
252 458.3265 Pain-management clinics.—
253 (1) REGISTRATION.—
254 (a)1. As used in this section, the term:
255 a. “Chronic nonmalignant pain” means pain unrelated to
256 cancer, or rheumatoid arthritis, or sickle cell anemia which
257 persists beyond the usual course of disease or beyond the injury
258 that is the cause of the pain or which persists more than 90
259 days after surgery.
260 b. “Pain-management clinic” or “clinic” means any publicly
261 or privately owned facility:
262 (I) That advertises in any medium for any type of pain
263 management services; or
264 (II) Where in any month a majority of patients are
265 prescribed opioids, benzodiazepines, barbiturates, or
266 carisoprodol for the treatment of chronic nonmalignant pain.
267 2. Each pain-management clinic must register with the
268 department unless:
269 a. The That clinic is licensed as a facility pursuant to
270 chapter 395;
271 b. The majority of the physicians who provide services in
272 the clinic primarily provide primarily surgical services;
273 c. The clinic is owned by a publicly held corporation whose
274 shares are traded on a national exchange or on the over-the
275 counter market and whose total assets at the end of the
276 corporation’s most recent fiscal quarter exceeded $50 million;
277 d. The clinic is affiliated with an accredited medical
278 school at which training is provided for medical students,
279 residents, or fellows;
280 e. The clinic does not prescribe controlled substances for
281 the treatment of pain;
282 f. The clinic is owned by a corporate entity exempt from
283 federal taxation under 26 U.S.C. s. 501(c)(3);
284 g. The clinic is wholly owned and operated by one or more
285 board-eligible or board-certified anesthesiologists,
286 physiatrists, psychiatrists, rheumatologists, or neurologists;
287 or
288 h. The clinic is wholly owned and operated by one or more
289 board-eligible or board-certified medical specialists who have
290 also completed fellowships in pain medicine approved by the
291 Accreditation Council for Graduate Medical Education, or who are
292 also board-eligible or board-certified in pain medicine by a
293 board approved by the American Board of Pain Medicine or the
294 American Board of Medical Specialties and perform interventional
295 pain procedures of the type routinely billed using surgical
296 codes;.
297 i. The clinic is organized as a physician-owned group
298 practice as defined in 42 C.F.R. 411,352; or
299 j. Before June 1, 2011, the clinic was wholly owned by
300 physicians who are not board eligible or board certified but who
301 successfully completed a residency program in anesthesiology,
302 physiatry, psychiatry, rheumatology, or neurology and who have 7
303 years of documented, full-time practice in pain medicine in this
304 state. For purposes of this paragraph, the term “full-time” is
305 defined as practicing an average of 20 hours per week each year
306 in pain medicine.
307 Section 3. Paragraph (a) of subsection (1) of section
308 459.0137, Florida Statutes, is amended to read:
309 459.0137 Pain-management clinics.—
310 (1) REGISTRATION.—
311 (a)1. As used in this section, the term:
312 a. “Chronic nonmalignant pain” means pain unrelated to
313 cancer, or rheumatoid arthritis, or sickle cell anemia which
314 persists beyond the usual course of disease or beyond the injury
315 that is the cause of the pain or which persists more than 90
316 days after surgery.
317 b. “Pain-management clinic” or “clinic” means any publicly
318 or privately owned facility:
319 (I) That advertises in any medium for any type of pain
320 management services; or
321 (II) Where in any month a majority of patients are
322 prescribed opioids, benzodiazepines, barbiturates, or
323 carisoprodol for the treatment of chronic nonmalignant pain.
324 2. Each pain-management clinic must register with the
325 department unless:
326 a. The That clinic is licensed as a facility pursuant to
327 chapter 395;
328 b. The majority of the physicians who provide services in
329 the clinic primarily provide primarily surgical services;
330 c. The clinic is owned by a publicly held corporation whose
331 shares are traded on a national exchange or on the over-the
332 counter market and whose total assets at the end of the
333 corporation’s most recent fiscal quarter exceeded $50 million;
334 d. The clinic is affiliated with an accredited medical
335 school at which training is provided for medical students,
336 residents, or fellows;
337 e. The clinic does not prescribe controlled substances for
338 the treatment of pain;
339 f. The clinic is owned by a corporate entity exempt from
340 federal taxation under 26 U.S.C. s. 501(c)(3);
341 g. The clinic is wholly owned and operated by one or more
342 board-eligible or board-certified anesthesiologists,
343 physiatrists, psychiatrists, rheumatologists, or neurologists;
344 or
345 h. The clinic is wholly owned and operated by one or more
346 board-eligible or board-certified medical specialists who have
347 also completed fellowships in pain medicine approved by the
348 Accreditation Council for Graduate Medical Education or the
349 American Osteopathic Association, or who are also board-eligible
350 or board-certified in pain medicine by a board approved by the
351 American Board of Medical Specialties, the American Association
352 of Physician Specialties, or the American Osteopathic
353 Association and perform interventional pain procedures of the
354 type routinely billed using surgical codes.
355 Section 4. Paragraph (b) of subsection (1) of section
356 465.0276, Florida Statutes, is amended to read:
357 465.0276 Dispensing practitioner.—
358 (1)
359 (b) A practitioner registered under this section may not
360 dispense a controlled substance listed in Schedule II or
361 Schedule III as provided in s. 893.03. This paragraph does not
362 apply to:
363 1. The dispensing of complimentary packages of medicinal
364 drugs which are labeled as a drug sample or complimentary drug
365 as defined in s. 499.028 to the practitioner’s own patients in
366 the regular course of her or his practice without the payment of
367 a fee or remuneration of any kind, whether direct or indirect,
368 as provided in subsection (5).
369 2. The dispensing of controlled substances in the health
370 care system of the Department of Corrections.
371 3. The dispensing of a controlled substance listed in
372 Schedule II or Schedule III in connection with the performance
373 of a surgical procedure. The amount dispensed pursuant to the
374 subparagraph may not exceed a 14-day supply. This exception does
375 not allow for the dispensing of a controlled substance listed in
376 Schedule II or Schedule III more than 14 days after the
377 performance of the surgical procedure. For purposes of this
378 subparagraph, the term “surgical procedure” means any procedure
379 in any setting which involves, or reasonably should involve:
380 a. Perioperative medication and sedation that allows the
381 patient to tolerate unpleasant procedures while maintaining
382 adequate cardiorespiratory function and the ability to respond
383 purposefully to verbal or tactile stimulation and makes intra-
384 and postoperative monitoring necessary; or
385 b. The use of general anesthesia or major conduction
386 anesthesia and preoperative sedation.
387 4. The dispensing of a controlled substance listed in
388 Schedule II or Schedule III pursuant to an approved clinical
389 trial. For purposes of this subparagraph, the term “approved
390 clinical trial” means a clinical research study or clinical
391 investigation that, in whole or in part, is state or federally
392 funded or is conducted under protocols approved an
393 investigational new drug application that is reviewed by the
394 United States Food and Drug Administration.
395 5. The dispensing of methadone in a facility licensed under
396 s. 397.427 where medication-assisted treatment for opiate
397 addiction is provided.
398 6. The dispensing of a controlled substance listed in
399 Schedule II or Schedule III to a patient of a facility licensed
400 under part IV of chapter 400.
401 Section 5. Paragraph (b) of subsection (5) and paragraph
402 (b) of subsection (7) of section 893.055, Florida Statutes, are
403 amended to read:
404 893.055 Prescription drug monitoring program.—
405 (5) When the following acts of dispensing or administering
406 occur, the following are exempt from reporting under this
407 section for that specific act of dispensing or administration:
408 (b) A pharmacist or health care practitioner when
409 administering a controlled substance to a patient who is
410 receiving hospice care or to a patient or resident receiving
411 care as a patient at a hospital, nursing home, ambulatory
412 surgical center, hospice, or intermediate care facility for the
413 developmentally disabled which is licensed in this state.
414 (7)
415 (b) A pharmacy, prescriber, or dispenser shall have access
416 to information in the prescription drug monitoring program’s
417 database which relates to a patient, or a potential patient, of
418 that pharmacy, prescriber, or dispenser in a manner established
419 by the department as needed for the purpose of reviewing the
420 patient’s controlled substance prescription history. Other
421 access to the program’s database shall be limited to the
422 program’s manager and to the designated program and support
423 staff, who may act only at the direction of the program manager
424 or, in the absence of the program manager, as authorized. Access
425 by the program manager or such designated staff is for
426 prescription drug program management only or for management of
427 the program’s database and its system in support of the
428 requirements of this section and in furtherance of the
429 prescription drug monitoring program. Confidential and exempt
430 information in the database shall be released only as provided
431 in paragraph (c) and s. 893.0551. The program manager,
432 designated program and support staff who act at the direction of
433 or in the absence of the program manager, and any individual who
434 has similar access regarding the management of the database from
435 the prescription drug monitoring program shall submit
436 fingerprints to the department for background screening. The
437 department shall follow the procedure established by the
438 Department of Law Enforcement to request a statewide criminal
439 history record check and to request that the Department of Law
440 Enforcement forward the fingerprints to the Federal Bureau of
441 Investigation for a national criminal history record check.
442 Section 6. This act shall take effect July 1, 2012.
