Florida Senate - 2016 SB 210
By Senator Grimsley
21-00028A-16 2016210__
1 A bill to be entitled
2 An act relating to health care; amending s. 110.12315,
3 F.S.; expanding the categories of persons who may
4 prescribe brand name drugs under the prescription drug
5 program when medically necessary; amending ss.
6 310.071, 310.073, and 310.081, F.S.; exempting
7 controlled substances prescribed by an advanced
8 registered nurse practitioner or a physician assistant
9 from the disqualifications for certification or
10 licensure, and for continued certification or
11 licensure, as a deputy pilot or state pilot; repealing
12 s. 383.336, F.S., relating to provider hospitals,
13 practice parameters, and peer review boards; amending
14 s. 395.1051, F.S.; requiring a hospital to provide
15 specified advance notice to certain obstetrical
16 physicians before it closes its obstetrical department
17 or ceases to provide obstetrical services; amending s.
18 456.072, F.S.; applying existing penalties for
19 violations relating to the prescribing or dispensing
20 of controlled substances by an advanced registered
21 nurse practitioner; amending s. 456.44, F.S.;
22 providing a definition; deleting an obsolete date;
23 requiring advanced registered nurse practitioners and
24 physician assistants who prescribe controlled
25 substances for certain pain to make a certain
26 designation, comply with registration requirements,
27 and follow specified standards of practice; providing
28 applicability; amending ss. 458.3265 and 459.0137,
29 F.S.; limiting the authority to prescribe a controlled
30 substance in a pain-management clinic only to a
31 physician licensed under ch. 458 or ch. 459, F.S.;
32 amending s. 458.347, F.S.; revising the required
33 continuing education requirements for a physician
34 assistant; requiring that a specified formulary limit
35 the prescription of certain controlled substances by
36 physician assistants as of a specified date; amending
37 s. 464.003, F.S.; redefining the term “advanced or
38 specialized nursing practice”; deleting the joint
39 committee established in the definition; amending s.
40 464.012, F.S.; requiring the Board of Nursing to
41 establish a committee to recommend a formulary of
42 controlled substances that may not be prescribed, or
43 may be prescribed only on a limited basis, by an
44 advanced registered nurse practitioner; specifying the
45 membership of the committee; providing parameters for
46 the formulary; requiring that the formulary be adopted
47 by board rule; specifying the process for amending the
48 formulary and imposing a burden of proof; limiting the
49 formulary’s application in certain instances;
50 requiring the board to adopt the committee’s initial
51 recommendations by a specified date; authorizing an
52 advanced registered nurse practitioner to prescribe,
53 dispense, administer, or order drugs, including
54 certain controlled substances under certain
55 circumstances, as of a specified date; amending s.
56 464.013, F.S.; revising continuing education
57 requirements for renewal of a license or certificate;
58 amending s. 464.018, F.S.; specifying acts that
59 constitute grounds for denial of a license or for
60 disciplinary action against an advanced registered
61 nurse practitioner; creating s. 627.42392, F.S.;
62 defining the term “health insurer”; requiring that
63 certain health insurers that do not already use a
64 certain form use only a prior authorization form
65 approved by the Financial Services Commission;
66 requiring the commission to adopt by rule guidelines
67 for such forms; amending s. 627.6131, F.S.;
68 prohibiting a health insurer from retroactively
69 denying a claim under specified circumstances;
70 creating s. 627.6466, F.S.; requiring an insurer to
71 allow a prescribing provider to request an override of
72 a restriction on the use of medication imposed through
73 a step-therapy or fail-first protocol; requiring the
74 insurer to grant such override within a specified
75 timeframe under certain circumstances; prohibiting the
76 duration of a step-therapy or fail-first protocol from
77 exceeding the time period specified by the prescribing
78 provider; providing that an override is not required
79 under certain circumstances; amending s. 641.3155,
80 F.S.; prohibiting a health maintenance organization
81 from retroactively denying a claim under specified
82 circumstances; creating s. 641.393, F.S.; requiring a
83 health maintenance organization to allow a prescribing
84 provider to request an override of a restriction on
85 the use of medication imposed through a step-therapy
86 or fail-first protocol; requiring the health
87 maintenance organization to grant such override within
88 a specified timeframe under certain circumstances;
89 prohibiting the duration of a step-therapy or fail
90 first protocol from exceeding the time period
91 specified by the prescribing provider; providing that
92 an override is not required under certain
93 circumstances; amending s. 893.02, F.S.; redefining
94 the term “practitioner” to include advanced registered
95 nurse practitioners and physician assistants under the
96 Florida Comprehensive Drug Abuse Prevention and
97 Control Act for the purpose of prescribing controlled
98 substances if a certain requirement is met; amending
99 s. 948.03, F.S.; providing that possession of drugs or
100 narcotics prescribed by an advanced registered nurse
101 practitioner or a physician assistant does not violate
102 a prohibition relating to the possession of drugs or
103 narcotics during probation; amending ss. 458.348 and
104 459.025, F.S.; conforming provisions to changes made
105 by the act; reenacting ss. 458.331(10), 458.347(7)(g),
106 459.015(10), 459.022(7)(f), and 465.0158(5)(b), F.S.,
107 to incorporate the amendment made to s. 456.072, F.S.,
108 in references thereto; reenacting ss. 456.072(1)(mm)
109 and 466.02751, F.S., to incorporate the amendment made
110 to s. 456.44, F.S., in references thereto; reenacting
111 ss. 458.303, 458.3475(7)(b), 459.022(4)(e) and (9)(c),
112 and 459.023(7)(b), F.S., to incorporate the amendment
113 made to s. 458.347, F.S., in references thereto;
114 reenacting s. 464.012(3)(c), F.S., to incorporate the
115 amendment made to s. 464.003, F.S., in a reference
116 thereto; reenacting ss. 456.041(1)(a), 458.348(1) and
117 (2), and 459.025(1), F.S., to incorporate the
118 amendment made to s. 464.012, F.S., in references
119 thereto; reenacting s. 464.0205(7), F.S., to
120 incorporate the amendment made to s. 464.013, F.S., in
121 a reference thereto; reenacting ss. 320.0848(11),
122 464.008(2), 464.009(5), and 464.0205(1)(b), (3), and
123 (4)(b), F.S., to incorporate the amendment made to s.
124 464.018, F.S., in references thereto; reenacting s.
125 775.051, F.S., to incorporate the amendment made to s.
126 893.02, F.S., in a reference thereto; reenacting ss.
127 944.17(3)(a), 948.001(8), and 948.101(1)(e), F.S., to
128 incorporate the amendment made to s. 948.03, F.S., in
129 references thereto; providing effective dates.
130
131 Be It Enacted by the Legislature of the State of Florida:
132
133 Section 1. Subsection (7) of section 110.12315, Florida
134 Statutes, is amended to read:
135 110.12315 Prescription drug program.—The state employees’
136 prescription drug program is established. This program shall be
137 administered by the Department of Management Services, according
138 to the terms and conditions of the plan as established by the
139 relevant provisions of the annual General Appropriations Act and
140 implementing legislation, subject to the following conditions:
141 (7) The department shall establish the reimbursement
142 schedule for prescription pharmaceuticals dispensed under the
143 program. Reimbursement rates for a prescription pharmaceutical
144 must be based on the cost of the generic equivalent drug if a
145 generic equivalent exists, unless the physician, advanced
146 registered nurse practitioner, or physician assistant
147 prescribing the pharmaceutical clearly states on the
148 prescription that the brand name drug is medically necessary or
149 that the drug product is included on the formulary of drug
150 products that may not be interchanged as provided in chapter
151 465, in which case reimbursement must be based on the cost of
152 the brand name drug as specified in the reimbursement schedule
153 adopted by the department.
154 Section 2. Paragraph (c) of subsection (1) of section
155 310.071, Florida Statutes, is amended, and subsection (3) of
156 that section is republished, to read:
157 310.071 Deputy pilot certification.—
158 (1) In addition to meeting other requirements specified in
159 this chapter, each applicant for certification as a deputy pilot
160 must:
161 (c) Be in good physical and mental health, as evidenced by
162 documentary proof of having satisfactorily passed a complete
163 physical examination administered by a licensed physician within
164 the preceding 6 months. The board shall adopt rules to establish
165 requirements for passing the physical examination, which rules
166 shall establish minimum standards for the physical or mental
167 capabilities necessary to carry out the professional duties of a
168 certificated deputy pilot. Such standards shall include zero
169 tolerance for any controlled substance regulated under chapter
170 893 unless that individual is under the care of a physician,
171 advanced registered nurse practitioner, or physician assistant
172 and that controlled substance was prescribed by that physician,
173 advanced registered nurse practitioner, or physician assistant.
174 To maintain eligibility as a certificated deputy pilot, each
175 certificated deputy pilot must annually provide documentary
176 proof of having satisfactorily passed a complete physical
177 examination administered by a licensed physician. The physician
178 must know the minimum standards and certify that the
179 certificateholder satisfactorily meets the standards. The
180 standards for certificateholders shall include a drug test.
181 (3) The initial certificate issued to a deputy pilot shall
182 be valid for a period of 12 months, and at the end of this
183 period, the certificate shall automatically expire and shall not
184 be renewed. During this period, the board shall thoroughly
185 evaluate the deputy pilot’s performance for suitability to
186 continue training and shall make appropriate recommendations to
187 the department. Upon receipt of a favorable recommendation by
188 the board, the department shall issue a certificate to the
189 deputy pilot, which shall be valid for a period of 2 years. The
190 certificate may be renewed only two times, except in the case of
191 a fully licensed pilot who is cross-licensed as a deputy pilot
192 in another port, and provided the deputy pilot meets the
193 requirements specified for pilots in paragraph (1)(c).
194 Section 3. Subsection (3) of section 310.073, Florida
195 Statutes, is amended to read:
196 310.073 State pilot licensing.—In addition to meeting other
197 requirements specified in this chapter, each applicant for
198 license as a state pilot must:
199 (3) Be in good physical and mental health, as evidenced by
200 documentary proof of having satisfactorily passed a complete
201 physical examination administered by a licensed physician within
202 the preceding 6 months. The board shall adopt rules to establish
203 requirements for passing the physical examination, which rules
204 shall establish minimum standards for the physical or mental
205 capabilities necessary to carry out the professional duties of a
206 licensed state pilot. Such standards shall include zero
207 tolerance for any controlled substance regulated under chapter
208 893 unless that individual is under the care of a physician,
209 advanced registered nurse practitioner, or physician assistant
210 and that controlled substance was prescribed by that physician,
211 advanced registered nurse practitioner, or physician assistant.
212 To maintain eligibility as a licensed state pilot, each licensed
213 state pilot must annually provide documentary proof of having
214 satisfactorily passed a complete physical examination
215 administered by a licensed physician. The physician must know
216 the minimum standards and certify that the licensee
217 satisfactorily meets the standards. The standards for licensees
218 shall include a drug test.
219 Section 4. Paragraph (b) of subsection (3) of section
220 310.081, Florida Statutes, is amended to read:
221 310.081 Department to examine and license state pilots and
222 certificate deputy pilots; vacancies.—
223 (3) Pilots shall hold their licenses or certificates
224 pursuant to the requirements of this chapter so long as they:
225 (b) Are in good physical and mental health as evidenced by
226 documentary proof of having satisfactorily passed a physical
227 examination administered by a licensed physician or physician
228 assistant within each calendar year. The board shall adopt rules
229 to establish requirements for passing the physical examination,
230 which rules shall establish minimum standards for the physical
231 or mental capabilities necessary to carry out the professional
232 duties of a licensed state pilot or a certificated deputy pilot.
233 Such standards shall include zero tolerance for any controlled
234 substance regulated under chapter 893 unless that individual is
235 under the care of a physician, advanced registered nurse
236 practitioner, or physician assistant and that controlled
237 substance was prescribed by that physician, advanced registered
238 nurse practitioner, or physician assistant. To maintain
239 eligibility as a certificated deputy pilot or licensed state
240 pilot, each certificated deputy pilot or licensed state pilot
241 must annually provide documentary proof of having satisfactorily
242 passed a complete physical examination administered by a
243 licensed physician. The physician must know the minimum
244 standards and certify that the certificateholder or licensee
245 satisfactorily meets the standards. The standards for
246 certificateholders and for licensees shall include a drug test.
247
248 Upon resignation or in the case of disability permanently
249 affecting a pilot’s ability to serve, the state license or
250 certificate issued under this chapter shall be revoked by the
251 department.
252 Section 5. Section 383.336, Florida Statutes, is repealed.
253 Section 6. Section 395.1051, Florida Statutes, is amended
254 to read:
255 395.1051 Duty to notify patients and physicians.—
256 (1) An appropriately trained person designated by each
257 licensed facility shall inform each patient, or an individual
258 identified pursuant to s. 765.401(1), in person about adverse
259 incidents that result in serious harm to the patient.
260 Notification of outcomes of care which that result in harm to
261 the patient under this section does shall not constitute an
262 acknowledgment or admission of liability and may not, nor can it
263 be introduced as evidence.
264 (2) A hospital shall notify each obstetrical physician who
265 has privileges at the hospital at least 90 days before the
266 hospital closes its obstetrical department or ceases to provide
267 obstetrical services.
268 Section 7. Subsection (7) of section 456.072, Florida
269 Statutes, is amended to read:
270 456.072 Grounds for discipline; penalties; enforcement.—
271 (7) Notwithstanding subsection (2), upon a finding that a
272 physician has prescribed or dispensed a controlled substance, or
273 caused a controlled substance to be prescribed or dispensed, in
274 a manner that violates the standard of practice set forth in s.
275 458.331(1)(q) or (t), s. 459.015(1)(t) or (x), s. 461.013(1)(o)
276 or (s), or s. 466.028(1)(p) or (x), or that an advanced
277 registered nurse practitioner has prescribed or dispensed a
278 controlled substance, or caused a controlled substance to be
279 prescribed or dispensed in a manner that violates the standard
280 of practice set forth in s. 464.018(1)(n) or s. 464.018(1)(p)6.,
281 the physician or advanced registered nurse practitioner shall be
282 suspended for a period of not less than 6 months and pay a fine
283 of not less than $10,000 per count. Repeated violations shall
284 result in increased penalties.
285 Section 8. Section 456.44, Florida Statutes, is amended to
286 read:
287 456.44 Controlled substance prescribing.—
288 (1) DEFINITIONS.— As used in this section, the term:
289 (a) “Addiction medicine specialist” means a board-certified
290 psychiatrist with a subspecialty certification in addiction
291 medicine or who is eligible for such subspecialty certification
292 in addiction medicine, an addiction medicine physician certified
293 or eligible for certification by the American Society of
294 Addiction Medicine, or an osteopathic physician who holds a
295 certificate of added qualification in Addiction Medicine through
296 the American Osteopathic Association.
297 (b) “Adverse incident” means any incident set forth in s.
298 458.351(4)(a)-(e) or s. 459.026(4)(a)-(e).
299 (c) “Board-certified pain management physician” means a
300 physician who possesses board certification in pain medicine by
301 the American Board of Pain Medicine, board certification by the
302 American Board of Interventional Pain Physicians, or board
303 certification or subcertification in pain management or pain
304 medicine by a specialty board recognized by the American
305 Association of Physician Specialists or the American Board of
306 Medical Specialties or an osteopathic physician who holds a
307 certificate in Pain Management by the American Osteopathic
308 Association.
309 (d) “Board eligible” means successful completion of an
310 anesthesia, physical medicine and rehabilitation, rheumatology,
311 or neurology residency program approved by the Accreditation
312 Council for Graduate Medical Education or the American
313 Osteopathic Association for a period of 6 years from successful
314 completion of such residency program.
315 (e) “Chronic nonmalignant pain” means pain unrelated to
316 cancer which persists beyond the usual course of disease or the
317 injury that is the cause of the pain or more than 90 days after
318 surgery.
319 (f) “Mental health addiction facility” means a facility
320 licensed under chapter 394 or chapter 397.
321 (g) “Registrant” means a physician, physician assistant, or
322 advanced registered nurse practitioner who meets the
323 requirements of subsection (2).
324 (2) REGISTRATION.—Effective January 1, 2012, A physician
325 licensed under chapter 458, chapter 459, chapter 461, or chapter
326 466, a physician assistant licensed under chapter 458 or chapter
327 459, or an advanced registered nurse practitioner certified
328 under part I of chapter 464 who prescribes any controlled
329 substance, listed in Schedule II, Schedule III, or Schedule IV
330 as defined in s. 893.03, for the treatment of chronic
331 nonmalignant pain, must:
332 (a) Designate himself or herself as a controlled substance
333 prescribing practitioner on his or her the physician’s
334 practitioner profile.
335 (b) Comply with the requirements of this section and
336 applicable board rules.
337 (3) STANDARDS OF PRACTICE.—The standards of practice in
338 this section do not supersede the level of care, skill, and
339 treatment recognized in general law related to health care
340 licensure.
341 (a) A complete medical history and a physical examination
342 must be conducted before beginning any treatment and must be
343 documented in the medical record. The exact components of the
344 physical examination shall be left to the judgment of the
345 registrant clinician who is expected to perform a physical
346 examination proportionate to the diagnosis that justifies a
347 treatment. The medical record must, at a minimum, document the
348 nature and intensity of the pain, current and past treatments
349 for pain, underlying or coexisting diseases or conditions, the
350 effect of the pain on physical and psychological function, a
351 review of previous medical records, previous diagnostic studies,
352 and history of alcohol and substance abuse. The medical record
353 shall also document the presence of one or more recognized
354 medical indications for the use of a controlled substance. Each
355 registrant must develop a written plan for assessing each
356 patient’s risk of aberrant drug-related behavior, which may
357 include patient drug testing. Registrants must assess each
358 patient’s risk for aberrant drug-related behavior and monitor
359 that risk on an ongoing basis in accordance with the plan.
360 (b) Each registrant must develop a written individualized
361 treatment plan for each patient. The treatment plan shall state
362 objectives that will be used to determine treatment success,
363 such as pain relief and improved physical and psychosocial
364 function, and shall indicate if any further diagnostic
365 evaluations or other treatments are planned. After treatment
366 begins, the registrant physician shall adjust drug therapy to
367 the individual medical needs of each patient. Other treatment
368 modalities, including a rehabilitation program, shall be
369 considered depending on the etiology of the pain and the extent
370 to which the pain is associated with physical and psychosocial
371 impairment. The interdisciplinary nature of the treatment plan
372 shall be documented.
373 (c) The registrant physician shall discuss the risks and
374 benefits of the use of controlled substances, including the
375 risks of abuse and addiction, as well as physical dependence and
376 its consequences, with the patient, persons designated by the
377 patient, or the patient’s surrogate or guardian if the patient
378 is incompetent. The registrant physician shall use a written
379 controlled substance agreement between the registrant physician
380 and the patient outlining the patient’s responsibilities,
381 including, but not limited to:
382 1. Number and frequency of controlled substance
383 prescriptions and refills.
384 2. Patient compliance and reasons for which drug therapy
385 may be discontinued, such as a violation of the agreement.
386 3. An agreement that controlled substances for the
387 treatment of chronic nonmalignant pain shall be prescribed by a
388 single treating registrant physician unless otherwise authorized
389 by the treating registrant physician and documented in the
390 medical record.
391 (d) The patient shall be seen by the registrant physician
392 at regular intervals, not to exceed 3 months, to assess the
393 efficacy of treatment, ensure that controlled substance therapy
394 remains indicated, evaluate the patient’s progress toward
395 treatment objectives, consider adverse drug effects, and review
396 the etiology of the pain. Continuation or modification of
397 therapy shall depend on the registrant’s physician’s evaluation
398 of the patient’s progress. If treatment goals are not being
399 achieved, despite medication adjustments, the registrant
400 physician shall reevaluate the appropriateness of continued
401 treatment. The registrant physician shall monitor patient
402 compliance in medication usage, related treatment plans,
403 controlled substance agreements, and indications of substance
404 abuse or diversion at a minimum of 3-month intervals.
405 (e) The registrant physician shall refer the patient as
406 necessary for additional evaluation and treatment in order to
407 achieve treatment objectives. Special attention shall be given
408 to those patients who are at risk for misusing their medications
409 and those whose living arrangements pose a risk for medication
410 misuse or diversion. The management of pain in patients with a
411 history of substance abuse or with a comorbid psychiatric
412 disorder requires extra care, monitoring, and documentation and
413 requires consultation with or referral to an addiction medicine
414 specialist or psychiatrist.
415 (f) A registrant physician registered under this section
416 must maintain accurate, current, and complete records that are
417 accessible and readily available for review and comply with the
418 requirements of this section, the applicable practice act, and
419 applicable board rules. The medical records must include, but
420 are not limited to:
421 1. The complete medical history and a physical examination,
422 including history of drug abuse or dependence.
423 2. Diagnostic, therapeutic, and laboratory results.
424 3. Evaluations and consultations.
425 4. Treatment objectives.
426 5. Discussion of risks and benefits.
427 6. Treatments.
428 7. Medications, including date, type, dosage, and quantity
429 prescribed.
430 8. Instructions and agreements.
431 9. Periodic reviews.
432 10. Results of any drug testing.
433 11. A photocopy of the patient’s government-issued photo
434 identification.
435 12. If a written prescription for a controlled substance is
436 given to the patient, a duplicate of the prescription.
437 13. The registrant’s physician’s full name presented in a
438 legible manner.
439 (g) A registrant shall immediately refer patients with
440 signs or symptoms of substance abuse shall be immediately
441 referred to a board-certified pain management physician, an
442 addiction medicine specialist, or a mental health addiction
443 facility as it pertains to drug abuse or addiction unless the
444 registrant is a physician who is board-certified or board
445 eligible in pain management. Throughout the period of time
446 before receiving the consultant’s report, a prescribing
447 registrant physician shall clearly and completely document
448 medical justification for continued treatment with controlled
449 substances and those steps taken to ensure medically appropriate
450 use of controlled substances by the patient. Upon receipt of the
451 consultant’s written report, the prescribing registrant
452 physician shall incorporate the consultant’s recommendations for
453 continuing, modifying, or discontinuing controlled substance
454 therapy. The resulting changes in treatment shall be
455 specifically documented in the patient’s medical record.
456 Evidence or behavioral indications of diversion shall be
457 followed by discontinuation of controlled substance therapy, and
458 the patient shall be discharged, and all results of testing and
459 actions taken by the registrant physician shall be documented in
460 the patient’s medical record.
461
462 This subsection does not apply to a board-eligible or board
463 certified anesthesiologist, physiatrist, rheumatologist, or
464 neurologist, or to a board-certified physician who has surgical
465 privileges at a hospital or ambulatory surgery center and
466 primarily provides surgical services. This subsection does not
467 apply to a board-eligible or board-certified medical specialist
468 who has also completed a fellowship in pain medicine approved by
469 the Accreditation Council for Graduate Medical Education or the
470 American Osteopathic Association, or who is board eligible or
471 board certified in pain medicine by the American Board of Pain
472 Medicine, the American Board of Interventional Pain Physicians,
473 the American Association of Physician Specialists, or a board
474 approved by the American Board of Medical Specialties or the
475 American Osteopathic Association and performs interventional
476 pain procedures of the type routinely billed using surgical
477 codes. This subsection does not apply to a registrant, advanced
478 registered nurse practitioner, or physician assistant who
479 prescribes medically necessary controlled substances for a
480 patient during an inpatient stay in a hospital licensed under
481 chapter 395.
482 Section 9. Paragraph (b) of subsection (2) of section
483 458.3265, Florida Statutes, is amended to read:
484 458.3265 Pain-management clinics.—
485 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
486 apply to any physician who provides professional services in a
487 pain-management clinic that is required to be registered in
488 subsection (1).
489 (b) Only a person may not dispense any medication on the
490 premises of a registered pain-management clinic unless he or she
491 is a physician licensed under this chapter or chapter 459 may
492 dispense medication or prescribe a controlled substance
493 regulated under chapter 893 on the premises of a registered
494 pain-management clinic.
495 Section 10. Paragraph (b) of subsection (2) of section
496 459.0137, Florida Statutes, is amended to read:
497 459.0137 Pain-management clinics.—
498 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
499 apply to any osteopathic physician who provides professional
500 services in a pain-management clinic that is required to be
501 registered in subsection (1).
502 (b) Only a person may not dispense any medication on the
503 premises of a registered pain-management clinic unless he or she
504 is a physician licensed under this chapter or chapter 458 may
505 dispense medication or prescribe a controlled substance
506 regulated under chapter 893 on the premises of a registered
507 pain-management clinic.
508 Section 11. Paragraph (e) of subsection (4) of section
509 458.347, Florida Statutes, is amended, and paragraph (c) of
510 subsection (9) of that section is republished, to read:
511 458.347 Physician assistants.—
512 (4) PERFORMANCE OF PHYSICIAN ASSISTANTS.—
513 (e) A supervisory physician may delegate to a fully
514 licensed physician assistant the authority to prescribe or
515 dispense any medication used in the supervisory physician’s
516 practice unless such medication is listed on the formulary
517 created pursuant to paragraph (f). A fully licensed physician
518 assistant may only prescribe or dispense such medication under
519 the following circumstances:
520 1. A physician assistant must clearly identify to the
521 patient that he or she is a physician assistant. Furthermore,
522 the physician assistant must inform the patient that the patient
523 has the right to see the physician prior to any prescription
524 being prescribed or dispensed by the physician assistant.
525 2. The supervisory physician must notify the department of
526 his or her intent to delegate, on a department-approved form,
527 before delegating such authority and notify the department of
528 any change in prescriptive privileges of the physician
529 assistant. Authority to dispense may be delegated only by a
530 supervising physician who is registered as a dispensing
531 practitioner in compliance with s. 465.0276.
532 3. The physician assistant must file with the department a
533 signed affidavit that he or she has completed a minimum of 10
534 continuing medical education hours in the specialty practice in
535 which the physician assistant has prescriptive privileges with
536 each licensure renewal application. Three of the 10 hours must
537 consist of a continuing education course on the safe and
538 effective prescribing of controlled substance medications
539 offered by a statewide professional association of physicians in
540 this state accredited to provide educational activities
541 designated for the American Medical Association Physician’s
542 Recognition Award Category I Credit or designated by the
543 American Academy of Physician Assistants as a Category 1 Credit.
544 4. The department may issue a prescriber number to the
545 physician assistant granting authority for the prescribing of
546 medicinal drugs authorized within this paragraph upon completion
547 of the foregoing requirements. The physician assistant shall not
548 be required to independently register pursuant to s. 465.0276.
549 5. The prescription must be written in a form that complies
550 with chapter 499 and must contain, in addition to the
551 supervisory physician’s name, address, and telephone number, the
552 physician assistant’s prescriber number. Unless it is a drug or
553 drug sample dispensed by the physician assistant, the
554 prescription must be filled in a pharmacy permitted under
555 chapter 465 and must be dispensed in that pharmacy by a
556 pharmacist licensed under chapter 465. The appearance of the
557 prescriber number creates a presumption that the physician
558 assistant is authorized to prescribe the medicinal drug and the
559 prescription is valid.
560 6. The physician assistant must note the prescription or
561 dispensing of medication in the appropriate medical record.
562 (9) COUNCIL ON PHYSICIAN ASSISTANTS.—The Council on
563 Physician Assistants is created within the department.
564 (c) The council shall:
565 1. Recommend to the department the licensure of physician
566 assistants.
567 2. Develop all rules regulating the use of physician
568 assistants by physicians under this chapter and chapter 459,
569 except for rules relating to the formulary developed under
570 paragraph (4)(f). The council shall also develop rules to ensure
571 that the continuity of supervision is maintained in each
572 practice setting. The boards shall consider adopting a proposed
573 rule developed by the council at the regularly scheduled meeting
574 immediately following the submission of the proposed rule by the
575 council. A proposed rule submitted by the council may not be
576 adopted by either board unless both boards have accepted and
577 approved the identical language contained in the proposed rule.
578 The language of all proposed rules submitted by the council must
579 be approved by both boards pursuant to each respective board’s
580 guidelines and standards regarding the adoption of proposed
581 rules. If either board rejects the council’s proposed rule, that
582 board must specify its objection to the council with
583 particularity and include any recommendations it may have for
584 the modification of the proposed rule.
585 3. Make recommendations to the boards regarding all matters
586 relating to physician assistants.
587 4. Address concerns and problems of practicing physician
588 assistants in order to improve safety in the clinical practices
589 of licensed physician assistants.
590 Section 12. Effective January 1, 2017, paragraph (f) of
591 subsection (4) of section 458.347, Florida Statutes, is amended
592 to read:
593 458.347 Physician assistants.—
594 (4) PERFORMANCE OF PHYSICIAN ASSISTANTS.—
595 (f)1. The council shall establish a formulary of medicinal
596 drugs that a fully licensed physician assistant having
597 prescribing authority under this section or s. 459.022 may not
598 prescribe. The formulary must include controlled substances as
599 defined in chapter 893, general anesthetics, and radiographic
600 contrast materials, and must limit the prescription of Schedule
601 II controlled substances as defined in s. 893.03 to a 7-day
602 supply. The formulary must also restrict the prescribing of
603 psychiatric mental health controlled substances for children
604 under 18 years of age.
605 2. In establishing the formulary, the council shall consult
606 with a pharmacist licensed under chapter 465, but not licensed
607 under this chapter or chapter 459, who shall be selected by the
608 State Surgeon General.
609 3. Only the council shall add to, delete from, or modify
610 the formulary. Any person who requests an addition, deletion, or
611 modification of a medicinal drug listed on such formulary has
612 the burden of proof to show cause why such addition, deletion,
613 or modification should be made.
614 4. The boards shall adopt the formulary required by this
615 paragraph, and each addition, deletion, or modification to the
616 formulary, by rule. Notwithstanding any provision of chapter 120
617 to the contrary, the formulary rule shall be effective 60 days
618 after the date it is filed with the Secretary of State. Upon
619 adoption of the formulary, the department shall mail a copy of
620 such formulary to each fully licensed physician assistant having
621 prescribing authority under this section or s. 459.022, and to
622 each pharmacy licensed by the state. The boards shall establish,
623 by rule, a fee not to exceed $200 to fund the provisions of this
624 paragraph and paragraph (e).
625 Section 13. Subsection (2) of section 464.003, Florida
626 Statutes, is amended to read:
627 464.003 Definitions.—As used in this part, the term:
628 (2) “Advanced or specialized nursing practice” means, in
629 addition to the practice of professional nursing, the
630 performance of advanced-level nursing acts approved by the board
631 which, by virtue of postbasic specialized education, training,
632 and experience, are appropriately performed by an advanced
633 registered nurse practitioner. Within the context of advanced or
634 specialized nursing practice, the advanced registered nurse
635 practitioner may perform acts of nursing diagnosis and nursing
636 treatment of alterations of the health status. The advanced
637 registered nurse practitioner may also perform acts of medical
638 diagnosis and treatment, prescription, and operation as
639 authorized within the framework of an established supervisory
640 protocol which are identified and approved by a joint committee
641 composed of three members appointed by the Board of Nursing, two
642 of whom must be advanced registered nurse practitioners; three
643 members appointed by the Board of Medicine, two of whom must
644 have had work experience with advanced registered nurse
645 practitioners; and the State Surgeon General or the State
646 Surgeon General’s designee. Each committee member appointed by a
647 board shall be appointed to a term of 4 years unless a shorter
648 term is required to establish or maintain staggered terms. The
649 Board of Nursing shall adopt rules authorizing the performance
650 of any such acts approved by the joint committee. Unless
651 otherwise specified by the joint committee, such acts must be
652 performed under the general supervision of a practitioner
653 licensed under chapter 458, chapter 459, or chapter 466 within
654 the framework of standing protocols which identify the medical
655 acts to be performed and the conditions for their performance.
656 The department may, by rule, require that a copy of the protocol
657 be filed with the department along with the notice required by
658 s. 458.348.
659 Section 14. Subsection (6) is added to section 464.012,
660 Florida Statutes, to read:
661 464.012 Certification of advanced registered nurse
662 practitioners; fees; controlled substance prescribing.—
663 (1) Any nurse desiring to be certified as an advanced
664 registered nurse practitioner shall apply to the department and
665 submit proof that he or she holds a current license to practice
666 professional nursing and that he or she meets one or more of the
667 following requirements as determined by the board:
668 (a) Satisfactory completion of a formal postbasic
669 educational program of at least one academic year, the primary
670 purpose of which is to prepare nurses for advanced or
671 specialized practice.
672 (b) Certification by an appropriate specialty board. Such
673 certification shall be required for initial state certification
674 and any recertification as a registered nurse anesthetist or
675 nurse midwife. The board may by rule provide for provisional
676 state certification of graduate nurse anesthetists and nurse
677 midwives for a period of time determined to be appropriate for
678 preparing for and passing the national certification
679 examination.
680 (c) Graduation from a program leading to a master’s degree
681 in a nursing clinical specialty area with preparation in
682 specialized practitioner skills. For applicants graduating on or
683 after October 1, 1998, graduation from a master’s degree program
684 shall be required for initial certification as a nurse
685 practitioner under paragraph (4)(c). For applicants graduating
686 on or after October 1, 2001, graduation from a master’s degree
687 program shall be required for initial certification as a
688 registered nurse anesthetist under paragraph (4)(a).
689 (2) The board shall provide by rule the appropriate
690 requirements for advanced registered nurse practitioners in the
691 categories of certified registered nurse anesthetist, certified
692 nurse midwife, and nurse practitioner.
693 (3) An advanced registered nurse practitioner shall perform
694 those functions authorized in this section within the framework
695 of an established protocol that is filed with the board upon
696 biennial license renewal and within 30 days after entering into
697 a supervisory relationship with a physician or changes to the
698 protocol. The board shall review the protocol to ensure
699 compliance with applicable regulatory standards for protocols.
700 The board shall refer to the department licensees submitting
701 protocols that are not compliant with the regulatory standards
702 for protocols. A practitioner currently licensed under chapter
703 458, chapter 459, or chapter 466 shall maintain supervision for
704 directing the specific course of medical treatment. Within the
705 established framework, an advanced registered nurse practitioner
706 may:
707 (a) Monitor and alter drug therapies.
708 (b) Initiate appropriate therapies for certain conditions.
709 (c) Perform additional functions as may be determined by
710 rule in accordance with s. 464.003(2).
711 (d) Order diagnostic tests and physical and occupational
712 therapy.
713 (4) In addition to the general functions specified in
714 subsection (3), an advanced registered nurse practitioner may
715 perform the following acts within his or her specialty:
716 (a) The certified registered nurse anesthetist may, to the
717 extent authorized by established protocol approved by the
718 medical staff of the facility in which the anesthetic service is
719 performed, perform any or all of the following:
720 1. Determine the health status of the patient as it relates
721 to the risk factors and to the anesthetic management of the
722 patient through the performance of the general functions.
723 2. Based on history, physical assessment, and supplemental
724 laboratory results, determine, with the consent of the
725 responsible physician, the appropriate type of anesthesia within
726 the framework of the protocol.
727 3. Order under the protocol preanesthetic medication.
728 4. Perform under the protocol procedures commonly used to
729 render the patient insensible to pain during the performance of
730 surgical, obstetrical, therapeutic, or diagnostic clinical
731 procedures. These procedures include ordering and administering
732 regional, spinal, and general anesthesia; inhalation agents and
733 techniques; intravenous agents and techniques; and techniques of
734 hypnosis.
735 5. Order or perform monitoring procedures indicated as
736 pertinent to the anesthetic health care management of the
737 patient.
738 6. Support life functions during anesthesia health care,
739 including induction and intubation procedures, the use of
740 appropriate mechanical supportive devices, and the management of
741 fluid, electrolyte, and blood component balances.
742 7. Recognize and take appropriate corrective action for
743 abnormal patient responses to anesthesia, adjunctive medication,
744 or other forms of therapy.
745 8. Recognize and treat a cardiac arrhythmia while the
746 patient is under anesthetic care.
747 9. Participate in management of the patient while in the
748 postanesthesia recovery area, including ordering the
749 administration of fluids and drugs.
750 10. Place special peripheral and central venous and
751 arterial lines for blood sampling and monitoring as appropriate.
752 (b) The certified nurse midwife may, to the extent
753 authorized by an established protocol which has been approved by
754 the medical staff of the health care facility in which the
755 midwifery services are performed, or approved by the nurse
756 midwife’s physician backup when the delivery is performed in a
757 patient’s home, perform any or all of the following:
758 1. Perform superficial minor surgical procedures.
759 2. Manage the patient during labor and delivery to include
760 amniotomy, episiotomy, and repair.
761 3. Order, initiate, and perform appropriate anesthetic
762 procedures.
763 4. Perform postpartum examination.
764 5. Order appropriate medications.
765 6. Provide family-planning services and well-woman care.
766 7. Manage the medical care of the normal obstetrical
767 patient and the initial care of a newborn patient.
768 (c) The nurse practitioner may perform any or all of the
769 following acts within the framework of established protocol:
770 1. Manage selected medical problems.
771 2. Order physical and occupational therapy.
772 3. Initiate, monitor, or alter therapies for certain
773 uncomplicated acute illnesses.
774 4. Monitor and manage patients with stable chronic
775 diseases.
776 5. Establish behavioral problems and diagnosis and make
777 treatment recommendations.
778 (5) The board shall certify, and the department shall issue
779 a certificate to, any nurse meeting the qualifications in this
780 section. The board shall establish an application fee not to
781 exceed $100 and a biennial renewal fee not to exceed $50. The
782 board is authorized to adopt such other rules as are necessary
783 to implement the provisions of this section.
784 (6)(a) The board shall establish a committee to recommend a
785 formulary of controlled substances that an advanced registered
786 nurse practitioner may not prescribe or may prescribe only for
787 specific uses or in limited quantities. The committee must
788 consist of three advanced registered nurse practitioners
789 licensed under this section, recommended by the Board of
790 Nursing; three physicians licensed under chapter 458 or chapter
791 459 who have work experience with advanced registered nurse
792 practitioners, recommended by the Board of Medicine; and a
793 pharmacist licensed under chapter 465 who holds a Doctor of
794 Pharmacy degree, recommended by the Board of Pharmacy. The
795 committee may recommend an evidence-based formulary applicable
796 to all advanced registered nurse practitioners which is limited
797 by specialty certification, is limited to approved uses of
798 controlled substances, or is subject to other similar
799 restrictions the committee finds are necessary to protect the
800 health, safety, and welfare of the public. The formulary must
801 restrict the prescribing of psychiatric mental health controlled
802 substances for children under 18 years of age to advanced
803 registered nurse practitioners who also are psychiatric nurses
804 as defined in s. 394.455. The formulary must also limit the
805 prescribing of Schedule II controlled substances as defined in
806 s. 893.03 to a 7-day supply, except that such restriction does
807 not apply to controlled substances that are psychiatric
808 medications prescribed by psychiatric nurses as defined in s.
809 394.455.
810 (b) The board shall adopt by rule the recommended formulary
811 and any revisions to the formulary which it finds are supported
812 by evidence-based clinical findings presented by the Board of
813 Medicine, the Board of Osteopathic Medicine, or the Board of
814 Dentistry.
815 (c) The formulary required under this subsection does not
816 apply to a controlled substance that is dispensed for
817 administration pursuant to an order, including an order for
818 medication authorized by subparagraph (4)(a)3., subparagraph
819 (4)(a)4., or subparagraph (4)(a)9.
820 (d) The board shall adopt the committee’s initial
821 recommendation no later October 31, 2016.
822 Section 15. Effective January 1, 2017, subsection (3) of
823 section 464.012, Florida Statutes, as amended by this act, is
824 amended to read:
825 464.012 Certification of advanced registered nurse
826 practitioners; fees; controlled substance prescribing.—
827 (3) An advanced registered nurse practitioner shall perform
828 those functions authorized in this section within the framework
829 of an established protocol that is filed with the board upon
830 biennial license renewal and within 30 days after entering into
831 a supervisory relationship with a physician or changes to the
832 protocol. The board shall review the protocol to ensure
833 compliance with applicable regulatory standards for protocols.
834 The board shall refer to the department licensees submitting
835 protocols that are not compliant with the regulatory standards
836 for protocols. A practitioner currently licensed under chapter
837 458, chapter 459, or chapter 466 shall maintain supervision for
838 directing the specific course of medical treatment. Within the
839 established framework, an advanced registered nurse practitioner
840 may:
841 (a) Prescribe, dispense, administer, or order any drug;
842 however, an advanced registered nurse practitioner may only
843 prescribe or dispense a controlled substance as defined in s.
844 893.03 if the advanced registered nurse practitioner has
845 graduated from a program leading to a master’s or doctoral
846 degree in a clinical nursing specialty area with training in
847 specialized practitioner skills. Monitor and alter drug
848 therapies.
849 (b) Initiate appropriate therapies for certain conditions.
850 (c) Perform additional functions as may be determined by
851 rule in accordance with s. 464.003(2).
852 (d) Order diagnostic tests and physical and occupational
853 therapy.
854 Section 16. Subsection (3) of section 464.013, Florida
855 Statutes, is amended to read:
856 464.013 Renewal of license or certificate.—
857 (3) The board shall by rule prescribe up to 30 hours of
858 continuing education biennially as a condition for renewal of a
859 license or certificate.
860 (a) A nurse who is certified by a health care specialty
861 program accredited by the National Commission for Certifying
862 Agencies or the Accreditation Board for Specialty Nursing
863 Certification is exempt from continuing education requirements.
864 The criteria for programs must shall be approved by the board.
865 (b) Notwithstanding the exemption in paragraph (a), as part
866 of the maximum 30 hours of continuing education hours required
867 under this subsection, advanced registered nurse practitioners
868 certified under s. 464.012 must complete at least 3 hours of
869 continuing education on the safe and effective prescription of
870 controlled substances. Such continuing education courses must be
871 offered by a statewide professional association of physicians in
872 this state accredited to provide educational activities
873 designated for the American Medical Association Physician’s
874 Recognition Award Category 1 Credit, the American Nurses
875 Credentialing Center, or the American Association of Nurse
876 Practitioners and may be offered in a distance-learning format.
877 Section 17. Paragraph (p) is added to subsection (1) of
878 section 464.018, Florida Statutes, and subsection (2) of that
879 section is republished, to read:
880 464.018 Disciplinary actions.—
881 (1) The following acts constitute grounds for denial of a
882 license or disciplinary action, as specified in s. 456.072(2):
883 (p) For an advanced registered nurse practitioner:
884 1. Presigning blank prescription forms.
885 2. Prescribing for office use any medicinal drug appearing
886 on Schedule II in chapter 893.
887 3. Prescribing, ordering, dispensing, administering,
888 supplying, selling, or giving a drug that is an amphetamine or a
889 sympathomimetic amine drug, or a compound designated in s.
890 893.03(2) as a Schedule II controlled substance, to or for any
891 person except for:
892 a. The treatment of narcolepsy; hyperkinesis; behavioral
893 syndrome in children characterized by the developmentally
894 inappropriate symptoms of moderate to severe distractibility,
895 short attention span, hyperactivity, emotional lability, and
896 impulsivity; or drug-induced brain dysfunction.
897 b. The differential diagnostic psychiatric evaluation of
898 depression or the treatment of depression shown to be refractory
899 to other therapeutic modalities.
900 c. The clinical investigation of the effects of such drugs
901 or compounds when an investigative protocol is submitted to,
902 reviewed by, and approved by the department before such
903 investigation is begun.
904 4. Prescribing, ordering, dispensing, administering,
905 supplying, selling, or giving growth hormones, testosterone or
906 its analogs, human chorionic gonadotropin (HCG), or other
907 hormones for the purpose of muscle building or to enhance
908 athletic performance. As used in this subparagraph, the term
909 “muscle building” does not include the treatment of injured
910 muscle. A prescription written for the drug products identified
911 in this subparagraph may be dispensed by a pharmacist with the
912 presumption that the prescription is for legitimate medical use.
913 5. Promoting or advertising on any prescription form a
914 community pharmacy unless the form also states: “This
915 prescription may be filled at any pharmacy of your choice.”
916 6. Prescribing, dispensing, administering, mixing, or
917 otherwise preparing a legend drug, including a controlled
918 substance, other than in the course of his or her professional
919 practice. For the purposes of this subparagraph, it is legally
920 presumed that prescribing, dispensing, administering, mixing, or
921 otherwise preparing legend drugs, including all controlled
922 substances, inappropriately or in excessive or inappropriate
923 quantities is not in the best interest of the patient and is not
924 in the course of the advanced registered nurse practitioner’s
925 professional practice, without regard to his or her intent.
926 7. Prescribing, dispensing, or administering a medicinal
927 drug appearing on any schedule set forth in chapter 893 to
928 himself or herself, except a drug prescribed, dispensed, or
929 administered to the advanced registered nurse practitioner by
930 another practitioner authorized to prescribe, dispense, or
931 administer medicinal drugs.
932 8. Prescribing, ordering, dispensing, administering,
933 supplying, selling, or giving amygdalin (laetrile) to any
934 person.
935 9. Dispensing a substance designated in s. 893.03(2) or (3)
936 as a substance controlled in Schedule II or Schedule III,
937 respectively, in violation of s. 465.0276.
938 10. Promoting or advertising through any communication
939 medium the use, sale, or dispensing of a substance designated in
940 s. 893.03 as a controlled substance.
941 (2) The board may enter an order denying licensure or
942 imposing any of the penalties in s. 456.072(2) against any
943 applicant for licensure or licensee who is found guilty of
944 violating any provision of subsection (1) of this section or who
945 is found guilty of violating any provision of s. 456.072(1).
946 Section 18. Section 627.42392, Florida Statutes, is created
947 to read:
948 627.42392 Prior authorization.—
949 (1) As used in this section, the term “health insurer”
950 means an authorized insurer offering health insurance as defined
951 in s. 624.603, a managed care plan as defined in s. 409.901(13),
952 or a health maintenance organization as defined in s.
953 641.19(12).
954 (2) Notwithstanding any other provision of law, in order to
955 establish uniformity in the submission of prior authorization
956 forms on or after January 1, 2017, a health insurer, or a
957 pharmacy benefits manager on behalf of the health insurer, which
958 does not use an electronic prior authorization form for its
959 contracted providers shall use only the prior authorization form
960 that has been approved by the Financial Services Commission to
961 obtain a prior authorization for a medical procedure, course of
962 treatment, or prescription drug benefit. Such form may not
963 exceed two pages in length, excluding any instructions or
964 guiding documentation.
965 (3) The Financial Services Commission shall adopt by rule
966 guidelines for all prior authorization forms which ensure the
967 general uniformity of such forms.
968 Section 19. Subsection (11) of section 627.6131, Florida
969 Statutes, is amended to read:
970 627.6131 Payment of claims.—
971 (11) A health insurer may not retroactively deny a claim
972 because of insured ineligibility:
973 (a) At any time, if the health insurer verified the
974 eligibility of an insured at the time of treatment and provided
975 an authorization number.
976 (b) More than 1 year after the date of payment of the
977 claim.
978 Section 20. Section 627.6466, Florida Statutes, is created
979 to read:
980 627.6466 Fail-first protocols.—If medication for the
981 treatment of a medical condition is restricted for use by an
982 insurer through a step-therapy or fail-first protocol, the
983 prescribing provider shall have access to a clear and convenient
984 process to request an override of such restriction from the
985 insurer. The insurer shall grant an override of the protocol
986 within 24 hours under the following circumstances:
987 (1) The prescribing provider determines, based on sound
988 clinical evidence, that the preferred treatment required under
989 the step-therapy or fail-first protocol has been ineffective in
990 the treatment of the insured’s disease or medical condition; or
991 (2) The prescribing provider believes, based on sound
992 clinical evidence or medical and scientific evidence, that the
993 preferred treatment required under the step-therapy or fail
994 first protocol:
995 (a) Is expected to, or is likely to, be ineffective given
996 the known relevant physical or mental characteristics and
997 medical history of the insured and the known characteristics of
998 the drug regimen; or
999 (b) Will cause, or is likely to cause, an adverse reaction
1000 or other physical harm to the insured.
1001 (3) If the prescribing provider allows the insured to enter
1002 the step-therapy or fail-first protocol recommended by the
1003 health insurer, the duration of the step-therapy or fail-first
1004 protocol may not exceed a period deemed appropriate by the
1005 provider. If the prescribing provider deems the treatment
1006 clinically ineffective, the insured is entitled to receive the
1007 recommended course of therapy and the prescribing provider is
1008 not required to seek approval for an override of the step
1009 therapy or fail-first protocol.
1010 Section 21. Subsection (10) of section 641.3155, Florida
1011 Statutes, is amended to read:
1012 641.3155 Prompt payment of claims.—
1013 (10) A health maintenance organization may not
1014 retroactively deny a claim because of subscriber ineligibility:
1015 (a) At any time, if the health maintenance organization
1016 verified the eligibility of an insured at the time of treatment
1017 and provided an authorization number.
1018 (b) More than 1 year after the date of payment of the
1019 claim.
1020 Section 22. Section 641.393, Florida Statutes, is created
1021 to read:
1022 641.393 Fail-first protocols.—If medication for the
1023 treatment of a medical condition is restricted for use by a
1024 health maintenance organization through a step-therapy or fail
1025 first protocol, the prescribing provider shall have access to a
1026 clear and convenient process to request an override of such
1027 restriction from the organization. The health maintenance
1028 organization shall grant an override of the protocol within 24
1029 hours under the following circumstances:
1030 (1) The prescribing provider determines, based on sound
1031 clinical evidence, that the preferred treatment required under
1032 step-therapy or fail-first protocol has been ineffective in the
1033 treatment of the subscriber’s disease or medical condition; or
1034 (2) The prescribing provider believes, based on sound
1035 clinical evidence or medical and scientific evidence, that the
1036 preferred treatment required under the step-therapy or fail
1037 first protocol:
1038 (a) Is expected to, or is likely to, be ineffective given
1039 the known relevant physical or mental characteristics and
1040 medical history of the subscriber and the known characteristics
1041 of the drug regimen; or
1042 (b) Will cause, or is likely to cause, an adverse reaction
1043 or other physical harm to the subscriber.
1044 (3) If the prescribing provider allows the subscriber to
1045 enter the step-therapy or fail-first protocol recommended by the
1046 health maintenance organization, the duration of the step
1047 therapy or fail-first protocol may not exceed a period deemed
1048 appropriate by the provider. If the prescribing provider deems
1049 the treatment clinically ineffective, the subscriber is entitled
1050 to receive the recommended course of therapy without requiring
1051 the prescribing provider to seek approval for an override of the
1052 step-therapy or fail-first protocol.
1053 Section 23. Subsection (21) of section 893.02, Florida
1054 Statutes, is amended to read:
1055 893.02 Definitions.—The following words and phrases as used
1056 in this chapter shall have the following meanings, unless the
1057 context otherwise requires:
1058 (21) “Practitioner” means a physician licensed under
1059 pursuant to chapter 458, a dentist licensed under pursuant to
1060 chapter 466, a veterinarian licensed under pursuant to chapter
1061 474, an osteopathic physician licensed under pursuant to chapter
1062 459, an advanced registered nurse practitioner certified under
1063 chapter 464, a naturopath licensed under pursuant to chapter
1064 462, a certified optometrist licensed under pursuant to chapter
1065 463, or a podiatric physician licensed under pursuant to chapter
1066 461, or a physician assistant licensed under chapter 458 or
1067 chapter 459, provided such practitioner holds a valid federal
1068 controlled substance registry number.
1069 Section 24. Paragraph (n) of subsection (1) of section
1070 948.03, Florida Statutes, is amended to read:
1071 948.03 Terms and conditions of probation.—
1072 (1) The court shall determine the terms and conditions of
1073 probation. Conditions specified in this section do not require
1074 oral pronouncement at the time of sentencing and may be
1075 considered standard conditions of probation. These conditions
1076 may include among them the following, that the probationer or
1077 offender in community control shall:
1078 (n) Be prohibited from using intoxicants to excess or
1079 possessing any drugs or narcotics unless prescribed by a
1080 physician, advanced registered nurse practitioner, or physician
1081 assistant. The probationer or community controllee may shall not
1082 knowingly visit places where intoxicants, drugs, or other
1083 dangerous substances are unlawfully sold, dispensed, or used.
1084 Section 25. Paragraph (a) of subsection (1) and subsection
1085 (2) of section 458.348, Florida Statutes, are amended to read:
1086 458.348 Formal supervisory relationships, standing orders,
1087 and established protocols; notice; standards.—
1088 (1) NOTICE.—
1089 (a) When a physician enters into a formal supervisory
1090 relationship or standing orders with an emergency medical
1091 technician or paramedic licensed pursuant to s. 401.27, which
1092 relationship or orders contemplate the performance of medical
1093 acts, or when a physician enters into an established protocol
1094 with an advanced registered nurse practitioner, which protocol
1095 contemplates the performance of medical acts identified and
1096 approved by the joint committee pursuant to s. 464.003(2) or
1097 acts set forth in s. 464.012(3) and (4), the physician shall
1098 submit notice to the board. The notice shall contain a statement
1099 in substantially the following form:
1100
1101 I, ...(name and professional license number of
1102 physician)..., of ...(address of physician)... have hereby
1103 entered into a formal supervisory relationship, standing orders,
1104 or an established protocol with ...(number of persons)...
1105 emergency medical technician(s), ...(number of persons)...
1106 paramedic(s), or ...(number of persons)... advanced registered
1107 nurse practitioner(s).
1108
1109 (2) ESTABLISHMENT OF STANDARDS BY JOINT COMMITTEE.—The
1110 joint committee created under s. 464.003(2) shall determine
1111 minimum standards for the content of established protocols
1112 pursuant to which an advanced registered nurse practitioner may
1113 perform medical acts identified and approved by the joint
1114 committee pursuant to s. 464.003(2) or acts set forth in s.
1115 464.012(3) and (4) and shall determine minimum standards for
1116 supervision of such acts by the physician, unless the joint
1117 committee determines that any act set forth in s. 464.012(3) or
1118 (4) is not a medical act. Such standards shall be based on risk
1119 to the patient and acceptable standards of medical care and
1120 shall take into account the special problems of medically
1121 underserved areas. The standards developed by the joint
1122 committee shall be adopted as rules by the Board of Nursing and
1123 the Board of Medicine for purposes of carrying out their
1124 responsibilities pursuant to part I of chapter 464 and this
1125 chapter, respectively, but neither board shall have disciplinary
1126 powers over the licensees of the other board.
1127 Section 26. Paragraph (a) of subsection (1) of section
1128 459.025, Florida Statutes, is amended to read:
1129 459.025 Formal supervisory relationships, standing orders,
1130 and established protocols; notice; standards.—
1131 (1) NOTICE.—
1132 (a) When an osteopathic physician enters into a formal
1133 supervisory relationship or standing orders with an emergency
1134 medical technician or paramedic licensed pursuant to s. 401.27,
1135 which relationship or orders contemplate the performance of
1136 medical acts, or when an osteopathic physician enters into an
1137 established protocol with an advanced registered nurse
1138 practitioner, which protocol contemplates the performance of
1139 medical acts identified and approved by the joint committee
1140 pursuant to s. 464.003(2) or acts set forth in s. 464.012(3) and
1141 (4), the osteopathic physician shall submit notice to the board.
1142 The notice must contain a statement in substantially the
1143 following form:
1144
1145 I, ...(name and professional license number of osteopathic
1146 physician)..., of ...(address of osteopathic physician)... have
1147 hereby entered into a formal supervisory relationship, standing
1148 orders, or an established protocol with ...(number of
1149 persons)... emergency medical technician(s), ...(number of
1150 persons)... paramedic(s), or ...(number of persons)... advanced
1151 registered nurse practitioner(s).
1152 Section 27. Subsection (10) of s. 458.331, paragraph (g) of
1153 subsection (7) of s. 458.347, subsection (10) of s. 459.015,
1154 paragraph (f) of subsection (7) of s. 459.022, and paragraph (b)
1155 of subsection (5) of s. 465.0158, Florida Statutes, are
1156 reenacted for the purpose of incorporating the amendment made by
1157 this act to s. 456.072, Florida Statutes, in references thereto.
1158 Section 28. Paragraph (mm) of subsection (1) of s. 456.072
1159 and s. 466.02751, Florida Statutes, are reenacted for the
1160 purpose of incorporating the amendment made by this act to s.
1161 456.44, Florida Statutes, in references thereto.
1162 Section 29. Section 458.303, paragraph (b) of subsection
1163 (7) of s. 458.3475, paragraph (e) of subsection (4) and
1164 paragraph (c) of subsection (9) of s. 459.022, and paragraph (b)
1165 of subsection (7) of s. 459.023, Florida Statutes, are reenacted
1166 for the purpose of incorporating the amendment made by this act
1167 to s. 458.347, Florida Statutes, in references thereto.
1168 Section 30. Paragraph (c) of subsection (3) of s. 464.012,
1169 Florida Statutes, is reenacted for the purpose of incorporating
1170 the amendment made by this act to s. 464.003, Florida Statutes,
1171 in a reference thereto.
1172 Section 31. Paragraph (a) of subsection (1) of s. 456.041,
1173 subsections (1) and (2) of s. 458.348, and subsection (1) of s.
1174 459.025, Florida Statutes, are reenacted for the purpose of
1175 incorporating the amendment made by this act to s. 464.012,
1176 Florida Statutes, in references thereto.
1177 Section 32. Subsection (7) of s. 464.0205, Florida
1178 Statutes, is reenacted for the purpose of incorporating the
1179 amendment made by this act to s. 464.013, Florida Statutes, in a
1180 reference thereto.
1181 Section 33. Subsection (11) of s. 320.0848, subsection (2)
1182 of s. 464.008, subsection (5) of s. 464.009, and paragraph (b)
1183 of subsection (1), subsection (3), and paragraph (b) of
1184 subsection (4) of s. 464.0205, Florida Statutes, are reenacted
1185 for the purpose of incorporating the amendment made by this act
1186 to s. 464.018, Florida Statutes, in references thereto.
1187 Section 34. Section 775.051, Florida Statutes, is reenacted
1188 for the purpose of incorporating the amendment made by this act
1189 to s. 893.02, Florida Statutes, in a reference thereto.
1190 Section 35. Paragraph (a) of subsection (3) of s. 944.17,
1191 subsection (8) of s. 948.001, and paragraph (e) of subsection
1192 (1) of s. 948.101, Florida Statutes, are reenacted for the
1193 purpose of incorporating the amendment made by this act to s.
1194 948.03, Florida Statutes, in references thereto.
1195 Section 36. Except as otherwise expressly provided in this
1196 act, this act shall take effect upon becoming a law.