Florida Senate - 2015 COMMITTEE AMENDMENT
Bill No. CS for CS for SB 614
Ì421698UÎ421698
LEGISLATIVE ACTION
Senate . House
Comm: WD .
04/20/2015 .
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The Committee on Rules (Soto) recommended the following:
1 Senate Amendment to Amendment (395678) (with title
2 amendment)
3
4 Delete lines 296 - 731
5 and insert:
6
7 This subsection does not apply to a board-eligible or board
8 certified anesthesiologist, physiatrist, rheumatologist, or
9 neurologist, or to a board-certified physician who has surgical
10 privileges at a hospital or ambulatory surgery center and
11 primarily provides surgical services. This subsection does not
12 apply to a board-eligible or board-certified medical specialist
13 who has also completed a fellowship in pain medicine approved by
14 the Accreditation Council for Graduate Medical Education or the
15 American Osteopathic Association, or who is board eligible or
16 board certified in pain medicine by the American Board of Pain
17 Medicine, the American Board of Interventional Pain Physicians,
18 the American Association of Physician Specialists, or a board
19 approved by the American Board of Medical Specialties or the
20 American Osteopathic Association and performs interventional
21 pain procedures of the type routinely billed using surgical
22 codes. This subsection does not apply to a registrant, advanced
23 registered nurse practitioner, or physician assistant who
24 prescribes medically necessary controlled substances for a
25 patient during an inpatient stay in a hospital licensed under
26 chapter 395.
27 Section 9. Section 458.326, Florida Statutes, is amended to
28 read:
29 458.326 Intractable pain; authorized treatment;
30 interventional pain medicine; unauthorized practice.—
31 (1)(a) For the purposes of this subsection section, the
32 term “intractable pain” means pain for which, in the generally
33 accepted course of medical practice, the cause cannot be removed
34 and otherwise treated.
35 (b)(2) Intractable pain must be diagnosed by a physician
36 licensed under this chapter and qualified by experience to
37 render such diagnosis.
38 (c)(3) Notwithstanding any other provision of law, a
39 physician may prescribe or administer any controlled substance
40 under Schedules II-V, as provided for in s. 893.03, to a person
41 for the treatment of intractable pain, provided the physician
42 does so in accordance with that level of care, skill, and
43 treatment recognized by a reasonably prudent physician under
44 similar conditions and circumstances.
45 (d)(4) Nothing in this section shall be construed to
46 condone, authorize, or approve mercy killing or euthanasia, and
47 no treatment authorized by this section may be used for such
48 purpose.
49 (2)(a) For the purposes of this subsection, the term
50 “interventional pain medicine” means the practice of medicine
51 devoted to the diagnosis and treatment of pain-related
52 disorders, principally with the application of interventional
53 techniques in managing chronic, intractable pain, independently
54 or in conjunction with other treatment modalities. These
55 techniques include minimally invasive procedures, including
56 percutaneous precision needle placement, with placement of drugs
57 in targeted areas or destruction of targeted nerves, and some
58 surgical techniques such as laser or endoscopic discectomy,
59 cement stabilization of spine fractures, intrathecal infusion
60 pumps, and spinal cord stimulators, for the diagnosis and
61 management of chronic, intractable pain.
62 (b) A person may not practice interventional pain medicine
63 or offer to practice interventional pain medicine unless such
64 acts are performed at facilities licensed under chapter 395 or
65 are performed by or under the direct supervision of a physician
66 licensed under this chapter or an osteopathic physician licensed
67 under chapter 459.
68 Section 10. Paragraph (b) of subsection (2) of section
69 458.3265, Florida Statutes, is amended to read:
70 458.3265 Pain-management clinics.—
71 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
72 apply to any physician who provides professional services in a
73 pain-management clinic that is required to be registered in
74 subsection (1).
75 (b) A person may not dispense any medication on the
76 premises of a registered pain-management clinic unless he or she
77 is a physician licensed under this chapter or chapter 459. A
78 person may not prescribe any controlled substance regulated
79 under chapter 893 on the premises of a registered pain
80 management clinic unless he or she is a physician licensed under
81 this chapter or chapter 459.
82 Section 11. Paragraph (b) of subsection (2) of section
83 459.0137, Florida Statutes, is amended to read:
84 459.0137 Pain-management clinics.—
85 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
86 apply to any osteopathic physician who provides professional
87 services in a pain-management clinic that is required to be
88 registered in subsection (1).
89 (b) A person may not dispense any medication on the
90 premises of a registered pain-management clinic unless he or she
91 is a physician licensed under this chapter or chapter 458. A
92 person may not prescribe any controlled substance regulated
93 under chapter 893 on the premises of a registered pain
94 management clinic unless he or she is a physician licensed under
95 this chapter or chapter 458.
96 Section 12. Paragraph (e) of subsection (4) of section
97 458.347, Florida Statutes, is amended, and paragraph (c) of
98 subsection (9) of that section is republished, to read:
99 458.347 Physician assistants.—
100 (4) PERFORMANCE OF PHYSICIAN ASSISTANTS.—
101 (e) A supervisory physician may delegate to a fully
102 licensed physician assistant the authority to prescribe or
103 dispense any medication used in the supervisory physician’s
104 practice unless such medication is listed on the formulary
105 created pursuant to paragraph (f). A fully licensed physician
106 assistant may only prescribe or dispense such medication under
107 the following circumstances:
108 1. A physician assistant must clearly identify to the
109 patient that he or she is a physician assistant. Furthermore,
110 the physician assistant must inform the patient that the patient
111 has the right to see the physician prior to any prescription
112 being prescribed or dispensed by the physician assistant.
113 2. The supervisory physician must notify the department of
114 his or her intent to delegate, on a department-approved form,
115 before delegating such authority and notify the department of
116 any change in prescriptive privileges of the physician
117 assistant. Authority to dispense may be delegated only by a
118 supervising physician who is registered as a dispensing
119 practitioner in compliance with s. 465.0276.
120 3. The physician assistant must file with the department a
121 signed affidavit that he or she has completed a minimum of 10
122 continuing medical education hours in the specialty practice in
123 which the physician assistant has prescriptive privileges with
124 each licensure renewal application. Three of the 10 hours must
125 consist of a continuing education course on the safe and
126 effective prescribing of controlled substance medications, which
127 shall be offered by a statewide professional association of
128 physicians in this state accredited to provide educational
129 activities designated for the American Medical Association
130 Physician’s Recognition Award Category I Credit.
131 4. The department may issue a prescriber number to the
132 physician assistant granting authority for the prescribing of
133 medicinal drugs authorized within this paragraph upon completion
134 of the foregoing requirements. The physician assistant shall not
135 be required to independently register pursuant to s. 465.0276.
136 5. The prescription must be written in a form that complies
137 with chapter 499 and must contain, in addition to the
138 supervisory physician’s name, address, and telephone number, the
139 physician assistant’s prescriber number. Unless it is a drug or
140 drug sample dispensed by the physician assistant, the
141 prescription must be filled in a pharmacy permitted under
142 chapter 465 and must be dispensed in that pharmacy by a
143 pharmacist licensed under chapter 465. The appearance of the
144 prescriber number creates a presumption that the physician
145 assistant is authorized to prescribe the medicinal drug and the
146 prescription is valid.
147 6. The physician assistant must note the prescription or
148 dispensing of medication in the appropriate medical record.
149 (9) COUNCIL ON PHYSICIAN ASSISTANTS.—The Council on
150 Physician Assistants is created within the department.
151 (c) The council shall:
152 1. Recommend to the department the licensure of physician
153 assistants.
154 2. Develop all rules regulating the use of physician
155 assistants by physicians under this chapter and chapter 459,
156 except for rules relating to the formulary developed under
157 paragraph (4)(f). The council shall also develop rules to ensure
158 that the continuity of supervision is maintained in each
159 practice setting. The boards shall consider adopting a proposed
160 rule developed by the council at the regularly scheduled meeting
161 immediately following the submission of the proposed rule by the
162 council. A proposed rule submitted by the council may not be
163 adopted by either board unless both boards have accepted and
164 approved the identical language contained in the proposed rule.
165 The language of all proposed rules submitted by the council must
166 be approved by both boards pursuant to each respective board’s
167 guidelines and standards regarding the adoption of proposed
168 rules. If either board rejects the council’s proposed rule, that
169 board must specify its objection to the council with
170 particularity and include any recommendations it may have for
171 the modification of the proposed rule.
172 3. Make recommendations to the boards regarding all matters
173 relating to physician assistants.
174 4. Address concerns and problems of practicing physician
175 assistants in order to improve safety in the clinical practices
176 of licensed physician assistants.
177 Section 13. Effective January 1, 2016, paragraph (f) of
178 subsection (4) of section 458.347, Florida Statutes, is amended
179 to read:
180 458.347 Physician assistants.—
181 (4) PERFORMANCE OF PHYSICIAN ASSISTANTS.—
182 (f)1. The council shall establish a formulary of medicinal
183 drugs that a fully licensed physician assistant having
184 prescribing authority under this section or s. 459.022 may not
185 prescribe. The formulary must include controlled substances as
186 defined in chapter 893, general anesthetics, and radiographic
187 contrast materials, and must limit the prescription of Schedule
188 II controlled substances as defined in s. 893.03 to a 7-day
189 supply. The formulary must also restrict the prescribing of
190 controlled substances that are psychotropic medications,
191 including antihypnotics, antipsychotics, antidepressants,
192 anxiety agents, sedatives, psychomotor stimulants, and mood
193 stabilizers for children under the age of 18.
194 2. In establishing the formulary, the council shall consult
195 with a pharmacist licensed under chapter 465, but not licensed
196 under this chapter or chapter 459, who shall be selected by the
197 State Surgeon General.
198 3. Only the council shall add to, delete from, or modify
199 the formulary. Any person who requests an addition, deletion, or
200 modification of a medicinal drug listed on such formulary has
201 the burden of proof to show cause why such addition, deletion,
202 or modification should be made.
203 4. The boards shall adopt the formulary required by this
204 paragraph, and each addition, deletion, or modification to the
205 formulary, by rule. Notwithstanding any provision of chapter 120
206 to the contrary, the formulary rule shall be effective 60 days
207 after the date it is filed with the Secretary of State. Upon
208 adoption of the formulary, the department shall mail a copy of
209 such formulary to each fully licensed physician assistant having
210 prescribing authority under this section or s. 459.022, and to
211 each pharmacy licensed by the state. The boards shall establish,
212 by rule, a fee not to exceed $200 to fund the provisions of this
213 paragraph and paragraph (e).
214 Section 14. Subsection (2) of section 464.003, Florida
215 Statutes, is amended to read:
216 464.003 Definitions.—As used in this part, the term:
217 (2) “Advanced or specialized nursing practice” means, in
218 addition to the practice of professional nursing, the
219 performance of advanced-level nursing acts approved by the board
220 which, by virtue of postbasic specialized education, training,
221 and experience, are appropriately performed by an advanced
222 registered nurse practitioner. Within the context of advanced or
223 specialized nursing practice, the advanced registered nurse
224 practitioner may perform acts of nursing diagnosis and nursing
225 treatment of alterations of the health status. The advanced
226 registered nurse practitioner may also perform acts of medical
227 diagnosis and treatment, prescription, and operation as
228 authorized within the framework of an established supervisory
229 protocol which are identified and approved by a joint committee
230 composed of three members appointed by the Board of Nursing, two
231 of whom must be advanced registered nurse practitioners; three
232 members appointed by the Board of Medicine, two of whom must
233 have had work experience with advanced registered nurse
234 practitioners; and the State Surgeon General or the State
235 Surgeon General’s designee. Each committee member appointed by a
236 board shall be appointed to a term of 4 years unless a shorter
237 term is required to establish or maintain staggered terms. The
238 Board of Nursing shall adopt rules authorizing the performance
239 of any such acts approved by the joint committee. Unless
240 otherwise specified by the joint committee, such acts must be
241 performed under the general supervision of a practitioner
242 licensed under chapter 458, chapter 459, or chapter 466 within
243 the framework of standing protocols which identify the medical
244 acts to be performed and the conditions for their performance.
245 The department may, by rule, require that a copy of the protocol
246 be filed with the department along with the notice required by
247 s. 458.348.
248 Section 15. Subsection (6) is added to section 464.012,
249 Florida Statutes, to read:
250 464.012 Certification of advanced registered nurse
251 practitioners; fees; controlled substance prescribing.—
252 (6)(a) The board shall establish a committee to recommend a
253 formulary of controlled substances that an advanced registered
254 nurse practitioner may not prescribe or may prescribe only for
255 specific uses or in limited quantities. The committee must
256 consist of three advanced registered nurse practitioners
257 licensed under s. 464.012, recommended by the Board of Nursing;
258 three physicians licensed under chapter 458 or chapter 459 who
259 have had work experience with advanced registered nurse
260 practitioners, recommended by the Board of Medicine; and a
261 pharmacist licensed under chapter 465 who holds a Doctor of
262 Pharmacy degree, recommended by the Board of Pharmacy. The
263 committee may recommend an evidence-based formulary applicable
264 to all advanced registered nurse practitioners, which is limited
265 by specially certification or to approved uses of controlled
266 substances, or subject to other similar restrictions the
267 committee finds are necessary to protect the health, safety, and
268 welfare of the public. The formulary must restrict the
269 prescribing of controlled substance psychotropic medications,
270 including antihypnotics, antipsychotics, antidepressants,
271 anxiety agents, sedatives, psychomotor stimulants, and mood
272 stabilizers for children under the age of 18 to psychiatric
273 nurses as defined in s. 394.455. The formulary must also limit
274 the prescribing of Schedule II controlled substances as defined
275 in s. 893.03 to a 7-day supply, except that such restriction
276 does not apply to controlled substances that are psychiatric
277 medications prescribed by psychiatric nurses as defined in s.
278 394.455.
279 (b) The board shall adopt by rule the recommended formulary
280 and recommended additions or deletions to the formulary which it
281 finds are supported by evidence-based clinical findings
282 presented by the Board of Medicine, the Board of Osteopathic
283 Medicine, or the Board of Dentistry.
284 (c) The formulary required under this subsection does not
285 apply to a controlled substance order that is dispensed for
286 administration including orders for medication authorized in
287 subparagraph (4)(a)3. or subparagraph (4)(a)4.
288 (d) The board shall adopt the committee’s initial
289 recommendation no later January 1, 2016.
290 Section 16. Effective January 1, 2016, subsection (3) of
291 section 464.012, Florida Statutes, is amended to read:
292 464.012 Certification of advanced registered nurse
293 practitioners; fees; controlled substance prescribing.—
294 (3) An advanced registered nurse practitioner shall perform
295 those functions authorized in this section within the framework
296 of an established protocol that is filed with the board upon
297 biennial license renewal and within 30 days after entering into
298 a supervisory relationship with a physician or changes to the
299 protocol. The board shall review the protocol to ensure
300 compliance with applicable regulatory standards for protocols.
301 The board shall refer to the department licensees submitting
302 protocols that are not compliant with the regulatory standards
303 for protocols. A practitioner currently licensed under chapter
304 458, chapter 459, or chapter 466 shall maintain supervision for
305 directing the specific course of medical treatment. Within the
306 established framework, an advanced registered nurse practitioner
307 may:
308 (a) Prescribe, dispense, administer, or order any drug;
309 however, an advanced registered nurse practitioner may only
310 prescribe or dispense a controlled substance as defined in s.
311 893.03 if the advanced registered nurse practitioner has
312 graduated from a program leading to a master’s degree in a
313 clinical nursing specialty area with training in specialized
314 practitioner skills. Monitor and alter drug therapies.
315 (b) Initiate appropriate therapies for certain conditions.
316 (c) Perform additional functions as may be determined by
317 rule in accordance with s. 464.003(2).
318 (d) Order diagnostic tests and physical and occupational
319 therapy.
320 Section 17. Subsection (3) of section 464.013, Florida
321 Statutes, is amended to read:
322 464.013 Renewal of license or certificate.—
323 (3) The board shall by rule prescribe up to 30 hours of
324 continuing education biennially as a condition for renewal of a
325 license or certificate.
326 (a) A nurse who is certified by a health care specialty
327 program accredited by the National Commission for Certifying
328 Agencies or the Accreditation Board for Specialty Nursing
329 Certification is exempt from continuing education requirements.
330 The criteria for programs must shall be approved by the board.
331 (b) Notwithstanding the exemption in paragraph (a), as part
332 of the maximum 30 hours of continuing education hours required
333 under this subsection, advanced registered nurse practitioners
334 certified under s. 464.012 must complete at least 3 hours of
335 continuing education on the safe and effective prescription of
336 controlled substances. Such continuing education courses must be
337 offered by a statewide professional association of physicians in
338 this state accredited to provide educational activities
339 designated for the American Medical Association Physician’s
340 Recognition Award Category 1 Credit, the American Nurses
341 Credentialing Center, or the American Association of Nurse
342 Practitioners and may be offered in a distance-learning format.
343 Section 18. Paragraph (p) is added to subsection (1) of
344 section 464.018, Florida Statutes, and subsection (2) of that
345 section is republished, to read:
346 464.018 Disciplinary actions.—
347 (1) The following acts constitute grounds for denial of a
348 license or disciplinary action, as specified in s. 456.072(2):
349 (p) For an advanced registered nurse practitioner:
350 1. Presigning blank prescription forms.
351 2. Prescribing for office use any medicinal drug appearing
352 on Schedule II in chapter 893.
353 3. Prescribing, ordering, dispensing, administering,
354 supplying, selling, or giving a drug that is an amphetamine or a
355 sympathomimetic amine drug, or a compound designated pursuant to
356 chapter 893 as a Schedule II controlled substance, to or for any
357 person except for:
358 a. The treatment of narcolepsy; hyperkinesis; behavioral
359 syndrome in children characterized by the developmentally
360 inappropriate symptoms of moderate to severe distractibility,
361 short attention span, hyperactivity, emotional lability, and
362 impulsivity; or drug-induced brain dysfunction.
363 b. The differential diagnostic psychiatric evaluation of
364 depression or the treatment of depression shown to be refractory
365 to other therapeutic modalities.
366 c. The clinical investigation of the effects of such drugs
367 or compounds when an investigative protocol is submitted to,
368 reviewed by, and approved by the department before such
369 investigation is begun.
370 4. Prescribing, ordering, dispensing, administering,
371 supplying, selling, or giving growth hormones, testosterone or
372 its analogs, human chorionic gonadotropin (HCG), or other
373 hormones for the purpose of muscle building or to enhance
374 athletic performance. As used in this subparagraph, the term
375 “muscle building” does not include the treatment of injured
376 muscle. A prescription written for the drug products listed in
377 this paragraph may be dispensed by a pharmacist with the
378 presumption that the prescription is for legitimate medical use.
379 5. Promoting or advertising on any prescription form a
380 community pharmacy unless the form also states: “This
381 prescription may be filled at any pharmacy of your choice.”
382 6. Prescribing, dispensing, administering, mixing, or
383 otherwise preparing a legend drug, including a controlled
384 substance, other than in the course of his or her professional
385 practice. For the purposes of this subparagraph, it is legally
386 presumed that prescribing, dispensing, administering, mixing, or
387 otherwise preparing legend drugs, including all controlled
388 substances, inappropriately or in excessive or inappropriate
389 quantities is not in the best interest of the patient and is not
390 in the course of the advanced registered nurse practitioner’s
391 professional practice, without regard to his or her intent.
392 7. Prescribing, dispensing, or administering a medicinal
393 drug appearing on any schedule set forth in chapter 893 to
394 himself or herself, except a drug prescribed, dispensed, or
395 administered to the advanced registered nurse practitioner by
396 another practitioner authorized to prescribe, dispense, or
397 administer medicinal drugs.
398 8. Prescribing, ordering, dispensing, administering,
399 supplying, selling, or giving amygdalin (laetrile) to any
400 person.
401 9. Dispensing a controlled substance listed on Schedule II
402 or Schedule III in chapter 893 in violation of s. 465.0276.
403 10. Promoting or advertising through any communication
404 medium the use, sale, or dispensing of a controlled substance
405 appearing on any schedule in chapter 893.
406 (2) The board may enter an order denying licensure or
407 imposing any of the penalties in s. 456.072(2) against any
408 applicant for licensure or licensee who is found guilty of
409 violating any provision of subsection (1) of this section or who
410 is found guilty of violating any provision of s. 456.072(1).
411
412 ================= T I T L E A M E N D M E N T ================
413 And the title is amended as follows:
414 Delete lines 908 - 952
415 and insert:
416 standards of practice; providing applicability;
417 amending s. 458.326, F.S.; defining the term
418 “interventional pain medicine”; restricting the
419 practice of interventional pain medicine to specified
420 circumstances; amending ss. 458.3265 and 459.0137,
421 F.S.; limiting the authority to prescribe a controlled
422 substance in a pain-management clinic to a physician
423 licensed under ch. 458 or ch. 459, F.S.; amending s.
424 458.347, F.S.; revising the required continuing
425 education requirements for a physician assistant;
426 amending s. 458.347, F.S.; requiring the Council of
427 Physician Assistants to create a formulary which
428 includes the controlled substances a physician
429 assistant is authorized to prescribe; amending s.
430 464.003, F.S.; redefining the term “advanced or
431 specialized nursing practice”; removing the joint
432 committee established in the definition; amending s.
433 464.012, F.S.; requiring the Board of Nursing to
434 establish a committee to make recommendations
435 regarding the need for adoption of a formulary of
436 controlled substances that may be prescribed by an
437 advanced registered nurse practitioner; specifying the
438 membership of the committee; providing parameters for
439 the recommendations of the committee; requiring that
440 any formulary be adopted by board rule; specifying the
441 process for amending the formulary and imposing a
442 burden of proof; limiting the formulary’s application
443 in certain instances; requiring the board to adopt the
444 committee’s initial recommendations by a specified
445 date; amending s. 464.012, F.S.; authorizing an
446 advanced registered nurse practitioner to prescribe,
447 dispense, administer, or order drugs, rather than to
448 monitor and alter drug therapies; providing an
449 exception; amending s. 464.013, F.S.; revising
450 conditions for renewal of a license or certificate;
451 amending s. 464.018, F.S.; specifying acts that
452 constitute grounds for denial of a license or for
453 disciplinary action against an advanced registered
454 nurse practitioner;