Florida Senate - 2014 SB 1420
By Senator Garcia
38-01115A-14 20141420__
1 A bill to be entitled
2 An act relating to medical practice; amending s.
3 456.44, F.S.; exempting certain physicians prescribing
4 controlled substances for the treatment of pain
5 associated with sickle cell disease from the standards
6 of practice for prescribing controlled substances;
7 amending ss. 458.347 and 459.022, F.S., relating to
8 physician assistants; removing the cap on the number
9 of physician assistants a physician may supervise;
10 providing that a physician assistant may perform
11 practice-related activities unless expressly
12 prohibited; requiring a physician assistant to certify
13 that he or she has completed continuing medical
14 education hours in a specialty practice in which he or
15 she has prescriptive privileges; specifying the drugs
16 to be included on the formulary a physician assistant
17 may not prescribe; deleting the requirement that a
18 person applying for licensure as a physician assistant
19 provide two letters of recommendation; providing an
20 effective date.
21
22 Be It Enacted by the Legislature of the State of Florida:
23
24 Section 1. Subsection (3) of section 456.44, Florida
25 Statutes, is amended to read:
26 456.44 Controlled substance prescribing.—
27 (3) STANDARDS OF PRACTICE.—The standards of practice
28 established under in this section do not supersede the level of
29 care, skill, and treatment recognized in general law related to
30 health care licensure.
31 (a) A complete medical history and a physical examination
32 must be conducted before beginning any treatment and must be
33 documented in the medical record. The exact components of the
34 physical examination shall be left to the judgment of the
35 clinician, who is expected to perform a physical examination
36 proportionate to the diagnosis that justifies a treatment. The
37 medical record must, at a minimum, document the nature and
38 intensity of the pain, current and past treatments for pain,
39 underlying or coexisting diseases or conditions, the effect of
40 the pain on physical and psychological function, a review of
41 previous medical records, previous diagnostic studies, and
42 history of alcohol and substance abuse. The medical record must
43 shall also document the presence of one or more recognized
44 medical indications for the use of a controlled substance. Each
45 registrant shall must develop a written plan for assessing the
46 each patient’s risk of aberrant drug-related behavior, which may
47 include patient drug testing. Registrants shall then must assess
48 each patient’s risk for aberrant drug-related behavior and
49 monitor that risk on an ongoing basis in accordance with the
50 plan.
51 (b) Each registrant shall must develop a written
52 individualized treatment plan for each patient. The treatment
53 plan must include shall state objectives for determining that
54 will be used to determine treatment success, such as pain relief
55 and improved physical and psychosocial function, and shall
56 indicate if any further diagnostic evaluations or other
57 treatments are planned. After treatment begins, the physician
58 shall adjust drug therapy to the individual medical needs of the
59 each patient. Other treatment modalities, including a
60 rehabilitation program, shall be considered depending on the
61 etiology of the pain and the extent to which the pain is
62 associated with physical and psychosocial impairment. The
63 interdisciplinary nature of the treatment plan shall be
64 documented.
65 (c) The physician shall discuss the risks and benefits of
66 the use of controlled substances, including the risks of abuse
67 and addiction, as well as physical dependence and its
68 consequences, with the patient, persons designated by the
69 patient, or the patient’s surrogate or guardian if the patient
70 is incompetent. The physician shall use a written controlled
71 substance agreement between the physician and the patient
72 specifying outlining the patient’s responsibilities which
73 includes, including, but is not limited to:
74 1. The number and frequency of controlled substance
75 prescriptions and refills.
76 2. Patient compliance and reasons for which drug therapy
77 may be discontinued, such as a violation of the agreement.
78 3. An agreement that controlled substances for the
79 treatment of chronic nonmalignant pain will shall be prescribed
80 by a single treating physician unless otherwise authorized by
81 the treating physician and documented in the medical record.
82 (d) The patient shall be seen by the physician at regular
83 intervals, not to exceed 3 months, to assess the efficacy of
84 treatment, ensure that controlled substance therapy remains
85 indicated, evaluate the patient’s progress toward treatment
86 objectives, consider adverse drug effects, and review the
87 etiology of the pain. Continuation or modification of therapy
88 depends shall depend on the physician’s evaluation of the
89 patient’s progress. If treatment goals are not being achieved,
90 despite medication adjustments, the physician shall reevaluate
91 the appropriateness of continued treatment. The physician shall
92 monitor patient compliance in medication usage, related
93 treatment plans, controlled substance agreements, and
94 indications of substance abuse or diversion at a minimum of 3
95 month intervals.
96 (e) The physician shall refer the patient as necessary for
97 additional evaluation and treatment in order to achieve
98 treatment objectives. Special attention shall be given to those
99 patients who are at risk for misusing their medications and
100 those whose living arrangements pose a risk for medication
101 misuse or diversion. The management of pain in patients who have
102 with a history of substance abuse or with a comorbid psychiatric
103 disorder requires extra care, monitoring, and documentation and
104 requires consultation with or referral to an addiction medicine
105 specialist or psychiatrist.
106 (f) A physician registered under this section must maintain
107 accurate, current, and complete records that are accessible and
108 readily available for review and comply with the requirements of
109 this section, the applicable practice act, and applicable board
110 rules. The medical records must include, but are not limited to:
111 1. The complete medical history and a physical examination,
112 including history of drug abuse or dependence.
113 2. Diagnostic, therapeutic, and laboratory results.
114 3. Evaluations and consultations.
115 4. Treatment objectives.
116 5. Discussion of risks and benefits.
117 6. Treatments.
118 7. Medications, including date, type, dosage, and quantity
119 prescribed.
120 8. Instructions and agreements.
121 9. Periodic reviews.
122 10. Results of any drug testing.
123 11. A photocopy of the patient’s government-issued photo
124 identification.
125 12. If a written prescription for a controlled substance is
126 given to the patient, a duplicate of the prescription.
127 13. The physician’s full name presented in a legible
128 manner.
129 (g) Patients with signs or symptoms of substance abuse
130 shall be immediately referred to a board-certified pain
131 management physician, an addiction medicine specialist, or a
132 mental health addiction facility as it pertains to drug abuse or
133 addiction unless the physician is board-certified or board
134 eligible in pain management. Throughout the period of time
135 before receiving the consultant’s report, a prescribing
136 physician shall clearly and completely document medical
137 justification for continued treatment with controlled substances
138 and those steps taken to ensure medically appropriate use of
139 controlled substances by the patient. Upon receipt of the
140 consultant’s written report, the prescribing physician shall
141 incorporate the consultant’s recommendations for continuing,
142 modifying, or discontinuing controlled substance therapy. The
143 resulting changes in treatment must shall be specifically
144 documented in the patient’s medical record. Evidence or
145 behavioral indications of diversion shall be followed by
146 discontinuation of controlled substance therapy, and the patient
147 shall be discharged, and all results of testing and actions
148 taken by the physician shall be documented in the patient’s
149 medical record.
150
151 This subsection does not apply to a board-eligible or board
152 certified anesthesiologist, physiatrist, rheumatologist, or
153 neurologist;, or to a board-certified physician who has surgical
154 privileges at a hospital or ambulatory surgery center and
155 primarily provides surgical services;. This subsection does not
156 apply to a board-eligible or board-certified medical specialist
157 who has also completed a fellowship in pain medicine approved by
158 the Accreditation Council for Graduate Medical Education or the
159 American Osteopathic Association, or who is board eligible or
160 board certified in pain medicine by the American Board of Pain
161 Medicine or a board approved by the American Board of Medical
162 Specialties or the American Osteopathic Association and performs
163 interventional pain procedures of the type routinely billed
164 using surgical codes; to an oncologist or hematologist
165 prescribing medically necessary controlled substances to a
166 patient for treatment of pain associated with progressive sickle
167 cell disease; or. This subsection does not apply to a physician
168 who prescribes medically necessary controlled substances for a
169 patient during an inpatient stay in a hospital licensed under
170 chapter 395.
171 Section 2. Subsection (3), subsection (4), and paragraphs
172 (a) and (c) of subsection (7) of section 458.347, Florida
173 Statutes, are amended to read:
174 458.347 Physician assistants.—
175 (3) PERFORMANCE OF SUPERVISING PHYSICIAN.—Each physician or
176 group of physicians supervising a licensed physician assistant
177 must be qualified in the medical areas in which the physician
178 assistant is to perform and is shall be individually or
179 collectively responsible and liable for the performance and the
180 acts and omissions of the physician assistant. A physician may
181 not supervise more than four currently licensed physician
182 assistants at any one time. A physician supervising a physician
183 assistant pursuant to this section is may not be required to
184 review and cosign charts or medical records prepared by the such
185 physician assistant.
186 (4) PERFORMANCE OF PHYSICIAN ASSISTANTS.—A physician
187 assistant may perform practice-related activities in accordance
188 with his or her education, training, and experience as delegated
189 by a supervisory physician unless expressly prohibited under
190 this chapter, chapter 459, or rules adopted to administer these
191 chapters.
192 (a) The boards shall adopt, by rule, the general principles
193 that supervising physicians must use in developing the scope of
194 practice of a physician assistant under direct supervision and
195 under indirect supervision. These principles must shall
196 recognize the diversity of both specialty and practice settings
197 in which physician assistants are used.
198 (b) This chapter does not prevent third-party payors from
199 reimbursing employers of physician assistants for covered
200 services rendered by licensed physician assistants.
201 (c) Licensed Physician assistants may not be denied
202 clinical hospital privileges, except for cause, so long as the
203 supervising physician is a staff member in good standing.
204 (d) A supervisory physician may delegate to a licensed
205 physician assistant, pursuant to a written protocol, the
206 authority to act according to s. 154.04(1)(c). Such delegated
207 authority is limited to the supervising physician’s practice in
208 connection with a county health department as defined and
209 established under pursuant to chapter 154. The boards shall
210 adopt rules governing the supervision of physician assistants by
211 physicians in county health departments.
212 (e) A supervisory physician may delegate to a fully
213 licensed physician assistant the authority to prescribe or
214 dispense any medication used in the supervisory physician’s
215 practice unless such medication is listed on the formulary
216 created pursuant to paragraph (f). A fully licensed physician
217 assistant may only prescribe or dispense such medication under
218 the following circumstances:
219 1. The A physician assistant must clearly identify to the
220 patient that he or she is a physician assistant. Furthermore,
221 The physician assistant must also inform the patient that the
222 patient has the right to see the physician before a prior to any
223 prescription is being prescribed or dispensed by the physician
224 assistant.
225 2. The supervisory physician must notify the department of
226 his or her intent to delegate, on a department-approved form,
227 before delegating such authority and notify the department of
228 any change in the prescriptive privileges of the physician
229 assistant. Authority to dispense may be delegated only by a
230 supervising physician who is registered as a dispensing
231 practitioner under in compliance with s. 465.0276.
232 3. At the time of license renewal, the physician assistant
233 must certify to file with the department a signed affidavit that
234 he or she has completed a minimum of 10 continuing medical
235 education hours in the specialty practice in which the physician
236 assistant has prescriptive privileges with each licensure
237 renewal application.
238 4. The department may issue a prescriber number to the
239 physician assistant granting authority for the prescribing of
240 medicinal drugs authorized within this paragraph upon completion
241 of the foregoing requirements. The physician assistant is shall
242 not be required to independently register pursuant to s.
243 465.0276.
244 5. The prescription must be written in a form that complies
245 with chapter 499 and must contain, in addition to the
246 supervisory physician’s name, address, and telephone number,
247 must contain the physician assistant’s prescriber number. Unless
248 it is a drug or drug sample dispensed by the physician
249 assistant, the prescription must be filled in a pharmacy
250 permitted under chapter 465 and must be dispensed in that
251 pharmacy by a pharmacist licensed under chapter 465. The
252 appearance of the prescriber number creates a presumption that
253 the physician assistant is authorized to prescribe the medicinal
254 drug and the prescription is valid.
255 6. The physician assistant must note the prescription or
256 dispensing of medication in the appropriate medical record.
257 (f)1. The council shall establish a formulary of medicinal
258 drugs that a fully licensed physician assistant having
259 prescribing authority under this section or s. 459.022 may not
260 prescribe. The formulary must include controlled substances
261 listed under schedules I and II as defined in chapter 893,
262 general anesthetics, and radiographic contrast materials.
263 1.2. In establishing the formulary, the council shall
264 consult with a pharmacist licensed under chapter 465, but not
265 licensed under this chapter or chapter 459, who shall be
266 selected by the State Surgeon General.
267 2.3. Only the council shall add to, delete from, or modify
268 the formulary. Any person who requests an addition, deletion, or
269 modification of a medicinal drug listed on the such formulary
270 has the burden of proof to show cause why such addition,
271 deletion, or modification should be made.
272 3.4. The boards shall adopt the formulary required by this
273 paragraph, and each addition, deletion, or modification to the
274 formulary, by rule. Notwithstanding any provision of chapter 120
275 to the contrary, the formulary rule is shall be effective 60
276 days after the date it is filed with the Secretary of State.
277 Upon adoption of the formulary, the department shall mail a copy
278 of the such formulary to each fully licensed physician assistant
279 having prescribing authority under this section or s. 459.022,
280 and to each pharmacy licensed by the state. The boards shall
281 establish, by rule, a fee not to exceed $200 to fund the
282 provisions of this paragraph and paragraph (e).
283 (g) A supervisory physician may delegate to a licensed
284 physician assistant the authority to order medications for the
285 supervisory physician’s patient during his or her care in a
286 facility licensed under chapter 395, notwithstanding any
287 provisions in chapter 465 or chapter 893 which may prohibit such
288 this delegation. For the purpose of this paragraph, an order is
289 not considered a prescription. A licensed physician assistant
290 working in a facility that is licensed under chapter 395 may
291 order any medication under the direction of the supervisory
292 physician.
293 (7) PHYSICIAN ASSISTANT LICENSURE.—
294 (a) A Any person desiring to be licensed as a physician
295 assistant must apply to the department. The department shall
296 issue a license to any person certified by the council as having
297 met the following requirements:
298 1. Is at least 18 years of age.
299 2. Has satisfactorily passed a proficiency examination by
300 an acceptable score established by the National Commission on
301 Certification of Physician Assistants. If an applicant does not
302 hold a current certificate issued by the National Commission on
303 Certification of Physician Assistants and has not actively
304 practiced as a physician assistant within the immediately
305 preceding 4 years, the applicant must retake and successfully
306 complete the entry-level examination of the National Commission
307 on Certification of Physician Assistants to be eligible for
308 licensure.
309 3. Has completed the application form and remitted an
310 application fee of up to not to exceed $300 as set by the
311 boards. An application for licensure made by a physician
312 assistant must include:
313 a. A certificate of completion of a physician assistant
314 training program specified in subsection (6).
315 b. A sworn statement of any prior felony convictions.
316 c. A sworn statement of any previous revocation or denial
317 of licensure or certification in any state.
318 d. Two letters of recommendation.
319 d.e. A copy of course transcripts and a copy of the course
320 description from a physician assistant training program
321 describing course content in pharmacotherapy, if the applicant
322 wishes to apply for prescribing authority. These documents must
323 meet the evidence requirements for prescribing authority.
324 (c) The license must be renewed biennially. Each renewal
325 must include:
326 1. A renewal fee not to exceed $500 as set by the boards.
327 2. A sworn statement of no felony convictions in the
328 previous 2 years.
329 Section 3. Subsections (3) and (4) and paragraphs (a) and
330 (b) of subsection (7) of section 459.022, Florida Statutes, are
331 amended to read:
332 459.022 Physician assistants.—
333 (3) PERFORMANCE OF SUPERVISING PHYSICIAN.—Each physician or
334 group of physicians supervising a licensed physician assistant
335 must be qualified in the medical areas in which the physician
336 assistant is to perform and is shall be individually or
337 collectively responsible and liable for the performance and the
338 acts and omissions of the physician assistant. A physician may
339 not supervise more than four currently licensed physician
340 assistants at any one time. A physician supervising a physician
341 assistant pursuant to this section is may not be required to
342 review and cosign charts or medical records prepared by such
343 physician assistant.
344 (4) PERFORMANCE OF PHYSICIAN ASSISTANTS.—A physician
345 assistant may perform practice-related activities in accordance
346 with his or her education, training, and experience as delegated
347 by a supervisory physician unless expressly prohibited under
348 this chapter, chapter 458, or rules adopted to administer these
349 chapters.
350 (a) The boards shall adopt, by rule, the general principles
351 that supervising physicians must use in developing the scope of
352 practice of a physician assistant under direct supervision and
353 under indirect supervision. These principles shall recognize the
354 diversity of both specialty and practice settings in which
355 physician assistants are used.
356 (b) This chapter does not prevent third-party payors from
357 reimbursing employers of physician assistants for covered
358 services rendered by licensed physician assistants.
359 (c) Licensed Physician assistants may not be denied
360 clinical hospital privileges, except for cause, so long as the
361 supervising physician is a staff member in good standing.
362 (d) A supervisory physician may delegate to a licensed
363 physician assistant, pursuant to a written protocol, the
364 authority to act according to s. 154.04(1)(c). Such delegated
365 authority is limited to the supervising physician’s practice in
366 connection with a county health department as defined and
367 established under pursuant to chapter 154. The boards shall
368 adopt rules governing the supervision of physician assistants by
369 physicians in county health departments.
370 (e) A supervisory physician may delegate to a fully
371 licensed physician assistant the authority to prescribe or
372 dispense any medication used in the supervisory physician’s
373 practice unless such medication is listed on the formulary
374 created pursuant to s. 458.347. A fully licensed physician
375 assistant may only prescribe or dispense such medication under
376 the following circumstances:
377 1. The A physician assistant must clearly identify to the
378 patient that she or he is a physician assistant. Furthermore,
379 The physician assistant must also inform the patient that the
380 patient has the right to see the physician before a prior to any
381 prescription is being prescribed or dispensed by the physician
382 assistant.
383 2. The supervisory physician must notify the department of
384 her or his intent to delegate, on a department-approved form,
385 before delegating such authority and notify the department of
386 any change in the prescriptive privileges of the physician
387 assistant. Authority to dispense may be delegated only by a
388 supervisory physician who is registered as a dispensing
389 practitioner under in compliance with s. 465.0276.
390 3. At the time of license renewal, the physician assistant
391 must certify to file with the department a signed affidavit that
392 she or he has completed a minimum of 10 continuing medical
393 education hours in the specialty practice in which the physician
394 assistant has prescriptive privileges with each licensure
395 renewal application.
396 4. The department may issue a prescriber number to the
397 physician assistant granting authority for the prescribing of
398 medicinal drugs authorized within this paragraph upon completion
399 of the foregoing requirements. The physician assistant is shall
400 not be required to independently register pursuant to s.
401 465.0276.
402 5. The prescription must be written in a form that complies
403 with chapter 499 and must contain, in addition to the
404 supervisory physician’s name, address, and telephone number,
405 contain the physician assistant’s prescriber number. Unless it
406 is a drug or drug sample dispensed by the physician assistant,
407 the prescription must be filled in a pharmacy permitted under
408 chapter 465, and must be dispensed in that pharmacy by a
409 pharmacist licensed under chapter 465. The appearance of the
410 prescriber number creates a presumption that the physician
411 assistant is authorized to prescribe the medicinal drug and the
412 prescription is valid.
413 6. The physician assistant must note the prescription or
414 dispensing of medication in the appropriate medical record.
415 (f) A supervisory physician may delegate to a licensed
416 physician assistant the authority to order medications for the
417 supervisory physician’s patient during his or her care in a
418 facility licensed under chapter 395, notwithstanding any
419 provisions in chapter 465 or chapter 893 which may prohibit such
420 this delegation. For the purpose of this paragraph, an order is
421 not considered a prescription. A licensed physician assistant
422 working in a facility that is licensed under chapter 395 may
423 order any medication under the direction of the supervisory
424 physician.
425 (7) PHYSICIAN ASSISTANT LICENSURE.—
426 (a) A Any person desiring to be licensed as a physician
427 assistant must apply to the department. The department shall
428 issue a license to any person certified by the council as having
429 met the following requirements:
430 1. Is at least 18 years of age.
431 2. Has satisfactorily passed a proficiency examination by
432 an acceptable score established by the National Commission on
433 Certification of Physician Assistants. If an applicant does not
434 hold a current certificate issued by the National Commission on
435 Certification of Physician Assistants and has not actively
436 practiced as a physician assistant within the immediately
437 preceding 4 years, the applicant must retake and successfully
438 complete the entry-level examination of the National Commission
439 on Certification of Physician Assistants to be eligible for
440 licensure.
441 3. Has completed the application form and remitted an
442 application fee of up to not to exceed $300 as set by the
443 boards. An application for licensure made by a physician
444 assistant must include:
445 a. A certificate of completion of a physician assistant
446 training program specified in subsection (6).
447 b. A sworn statement of any prior felony convictions.
448 c. A sworn statement of any previous revocation or denial
449 of licensure or certification in any state.
450 d. Two letters of recommendation.
451 d.e. A copy of course transcripts and a copy of the course
452 description from a physician assistant training program
453 describing course content in pharmacotherapy, if the applicant
454 wishes to apply for prescribing authority. These documents must
455 meet the evidence requirements for prescribing authority.
456 (b) The licensure must be renewed biennially. Each renewal
457 must include:
458 1. A renewal fee not to exceed $500 as set by the boards.
459 2. A sworn statement of no felony convictions in the
460 previous 2 years.
461 Section 4. This act shall take effect July 1, 2014.