Florida Senate - 2015 CS for CS for CS for SB 614
By the Committees on Rules; Regulated Industries; and Health
Policy; and Senator Grimsley
595-04422-15 2015614c3
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.
18 409.967, F.S.; requiring a Medicaid managed care plan
19 to allow a prescribing provider to request an override
20 of a restriction on the use of medication imposed
21 through a step-therapy or fail-first protocol;
22 requiring the plan to grant such override within a
23 specified timeframe under certain circumstances;
24 prohibiting the duration of a step-therapy or fail
25 first protocol from exceeding the time period
26 specified by the prescribing provider; providing that
27 an override is not required under certain
28 circumstances; amending s. 456.072, F.S.; applying
29 existing penalties for violations relating to the
30 prescribing or dispensing of controlled substances by
31 an advanced registered nurse practitioner; amending s.
32 456.44, F.S.; deleting an obsolete date; requiring
33 advanced registered nurse practitioners and physician
34 assistants who prescribe controlled substances for
35 certain pain to make a certain designation, comply
36 with registration requirements, and follow specified
37 standards of practice; providing applicability;
38 amending s. 458.326, F.S.; defining the term
39 “interventional pain medicine”; restricting the
40 practice of interventional pain medicine to specified
41 circumstances; amending ss. 458.3265 and 459.0137,
42 F.S.; limiting the authority to prescribe a controlled
43 substance in a pain-management clinic only to a
44 physician licensed under ch. 458 or ch. 459, F.S.;
45 amending s. 458.347, F.S.; revising the required
46 continuing education requirements for a physician
47 assistant; requiring that a specified formulary limit
48 the prescription of certain controlled substances by
49 physician assistants as of a specified date; amending
50 s. 464.003, F.S.; redefining the term “advanced or
51 specialized nursing practice”; deleting the joint
52 committee established in the definition; amending s.
53 464.012, F.S.; requiring the Board of Nursing to
54 establish a committee to recommend a formulary of
55 controlled substances that may not be prescribed, or
56 may be prescribed only on a limited basis, by an
57 advanced registered nurse practitioner; specifying the
58 membership of the committee; providing parameters for
59 the formulary; requiring that any formulary be adopted
60 by board rule; specifying the process for amending the
61 formulary and imposing a burden of proof; limiting the
62 formulary’s application in certain instances;
63 requiring the board to adopt the committee’s initial
64 recommendations by a specified date; authorizing an
65 advanced registered nurse practitioner to prescribe,
66 dispense, administer, or order drugs, including
67 certain controlled substances under certain
68 circumstances, as of a specified date; amending s.
69 464.013, F.S.; revising continuing education
70 requirements for renewal of a license or certificate;
71 amending s. 464.018, F.S.; specifying acts that
72 constitute grounds for denial of a license or for
73 disciplinary action against an advanced registered
74 nurse practitioner; creating s. 627.42392, F.S.;
75 defining the term “health insurer”; requiring that
76 certain health insurers, which do not already use a
77 certain form, use only a prior authorization form
78 approved by the Financial Services Commission;
79 requiring the commission to adopt by rule guidelines
80 for such forms; amending s. 627.6131, F.S.;
81 prohibiting a health insurer from retroactively
82 denying a claim under specified circumstances;
83 creating s. 627.6466, F.S.; requiring an insurer to
84 allow a prescribing provider to request an override of
85 a restriction on the use of medication imposed through
86 a step-therapy or fail-first protocol; requiring the
87 insurer to grant such override within a specified
88 timeframe under certain circumstances; prohibiting the
89 duration of a step-therapy or fail-first protocol from
90 exceeding the time period specified by the prescribing
91 provider; providing that an override is not required
92 under certain circumstances; amending s. 641.3155,
93 F.S.; prohibiting a health maintenance organization
94 from retroactively denying a claim under specified
95 circumstances; creating s. 641.393, F.S.; requiring a
96 health maintenance organization to allow a prescribing
97 provider to request an override of a restriction on
98 the use of medication imposed through a step-therapy
99 or fail-first protocol; requiring the health
100 maintenance organization to grant such override within
101 a specified timeframe under certain circumstances;
102 prohibiting the duration of a step-therapy or fail
103 first protocol from exceeding the time period
104 specified by the prescribing provider; providing that
105 an override is not required under certain
106 circumstances; amending s. 893.02, F.S.; redefining
107 the term “practitioner” to include advanced registered
108 nurse practitioners and physician assistants under the
109 Florida Comprehensive Drug Abuse Prevention and
110 Control Act for the purpose of prescribing controlled
111 substances if a certain requirement is met; amending
112 s. 948.03, F.S.; providing that possession of drugs or
113 narcotics prescribed by an advanced registered nurse
114 practitioner or physician assistant does not violate a
115 prohibition relating to the possession of drugs or
116 narcotics during probation; amending ss. 458.348 and
117 459.025, F.S.; conforming provisions to changes made
118 by the act; reenacting ss. 458.331(10), 458.347(7)(g),
119 459.015(10), 459.022(7)(f), and 465.0158(5)(b), F.S.,
120 to incorporate the amendment made to s. 456.072, F.S.,
121 in references thereto; reenacting ss. 456.072(1)(mm)
122 and 466.02751, F.S., to incorporate the amendment made
123 to s. 456.44, F.S., in references thereto; reenacting
124 ss. 458.303, 458.3475(7)(b), 459.022(4)(e) and (9)(c),
125 and 459.023(7)(b), F.S., to incorporate the amendment
126 made to s. 458.347, F.S., in references thereto;
127 reenacting s. 464.012(3)(c), F.S., to incorporate the
128 amendment made to s. 464.003, F.S., in a reference
129 thereto; reenacting ss. 456.041(1)(a), 458.348(1) and
130 (2), and 459.025(1), F.S., to incorporate the
131 amendment made to s. 464.012, F.S., in references
132 thereto; reenacting s. 464.0205(7), F.S., to
133 incorporate the amendment made to s. 464.013, F.S., in
134 a reference thereto; reenacting ss. 320.0848(11),
135 464.008(2), 464.009(5), and 464.0205(1)(b), (3), and
136 (4)(b), F.S., to incorporate the amendment made to s.
137 464.018, F.S., in references thereto; reenacting s.
138 775.051, F.S., to incorporate the amendment made to s.
139 893.02, F.S., in a reference thereto; reenacting ss.
140 944.17(3)(a), 948.001(8), and 948.101(1)(e), F.S., to
141 incorporate the amendment made to s. 948.03, F.S., in
142 references thereto; providing effective dates.
143
144 WHEREAS, the Legislature recognizes the importance of
145 access to primary health care for citizens of Florida, most
146 especially for those who reside in the medically underserved
147 areas of the state, and
148 WHEREAS, the Legislature further recognizes that there is a
149 state and national shortage of primary care providers which
150 necessitates the removal of regulatory barriers that prevent
151 advanced registered nurse practitioners and physician assistants
152 from practicing to the full extent of their education, training,
153 and certifications, NOW, THEREFORE,
154
155 Be It Enacted by the Legislature of the State of Florida:
156
157 Section 1. Subsection (7) of section 110.12315, Florida
158 Statutes, is amended to read:
159 110.12315 Prescription drug program.—The state employees’
160 prescription drug program is established. This program shall be
161 administered by the Department of Management Services, according
162 to the terms and conditions of the plan as established by the
163 relevant provisions of the annual General Appropriations Act and
164 implementing legislation, subject to the following conditions:
165 (7) The department shall establish the reimbursement
166 schedule for prescription pharmaceuticals dispensed under the
167 program. Reimbursement rates for a prescription pharmaceutical
168 must be based on the cost of the generic equivalent drug if a
169 generic equivalent exists, unless the physician, advanced
170 registered nurse practitioner, or physician assistant
171 prescribing the pharmaceutical clearly states on the
172 prescription that the brand name drug is medically necessary or
173 that the drug product is included on the formulary of drug
174 products that may not be interchanged as provided in chapter
175 465, in which case reimbursement must be based on the cost of
176 the brand name drug as specified in the reimbursement schedule
177 adopted by the department.
178 Section 2. Paragraph (c) of subsection (1) of section
179 310.071, Florida Statutes, is amended, and subsection (3) of
180 that section is republished, to read:
181 310.071 Deputy pilot certification.—
182 (1) In addition to meeting other requirements specified in
183 this chapter, each applicant for certification as a deputy pilot
184 must:
185 (c) Be in good physical and mental health, as evidenced by
186 documentary proof of having satisfactorily passed a complete
187 physical examination administered by a licensed physician within
188 the preceding 6 months. The board shall adopt rules to establish
189 requirements for passing the physical examination, which rules
190 shall establish minimum standards for the physical or mental
191 capabilities necessary to carry out the professional duties of a
192 certificated deputy pilot. Such standards shall include zero
193 tolerance for any controlled substance regulated under chapter
194 893 unless that individual is under the care of a physician,
195 advanced registered nurse practitioner, or physician assistant
196 and that controlled substance was prescribed by that physician,
197 advanced registered nurse practitioner, or physician assistant.
198 To maintain eligibility as a certificated deputy pilot, each
199 certificated deputy pilot must annually provide documentary
200 proof of having satisfactorily passed a complete physical
201 examination administered by a licensed physician. The physician
202 must know the minimum standards and certify that the
203 certificateholder satisfactorily meets the standards. The
204 standards for certificateholders shall include a drug test.
205 (3) The initial certificate issued to a deputy pilot shall
206 be valid for a period of 12 months, and at the end of this
207 period, the certificate shall automatically expire and shall not
208 be renewed. During this period, the board shall thoroughly
209 evaluate the deputy pilot’s performance for suitability to
210 continue training and shall make appropriate recommendations to
211 the department. Upon receipt of a favorable recommendation by
212 the board, the department shall issue a certificate to the
213 deputy pilot, which shall be valid for a period of 2 years. The
214 certificate may be renewed only two times, except in the case of
215 a fully licensed pilot who is cross-licensed as a deputy pilot
216 in another port, and provided the deputy pilot meets the
217 requirements specified for pilots in paragraph (1)(c).
218 Section 3. Subsection (3) of section 310.073, Florida
219 Statutes, is amended to read:
220 310.073 State pilot licensing.—In addition to meeting other
221 requirements specified in this chapter, each applicant for
222 license as a state pilot must:
223 (3) Be in good physical and mental health, as evidenced by
224 documentary proof of having satisfactorily passed a complete
225 physical examination administered by a licensed physician within
226 the preceding 6 months. The board shall adopt rules to establish
227 requirements for passing the physical examination, which rules
228 shall establish minimum standards for the physical or mental
229 capabilities necessary to carry out the professional duties of a
230 licensed state pilot. Such standards shall include zero
231 tolerance for any controlled substance regulated under chapter
232 893 unless that individual is under the care of a physician,
233 advanced registered nurse practitioner, or physician assistant
234 and that controlled substance was prescribed by that physician,
235 advanced registered nurse practitioner, or physician assistant.
236 To maintain eligibility as a licensed state pilot, each licensed
237 state pilot must annually provide documentary proof of having
238 satisfactorily passed a complete physical examination
239 administered by a licensed physician. The physician must know
240 the minimum standards and certify that the licensee
241 satisfactorily meets the standards. The standards for licensees
242 shall include a drug test.
243 Section 4. Paragraph (b) of subsection (3) of section
244 310.081, Florida Statutes, is amended to read:
245 310.081 Department to examine and license state pilots and
246 certificate deputy pilots; vacancies.—
247 (3) Pilots shall hold their licenses or certificates
248 pursuant to the requirements of this chapter so long as they:
249 (b) Are in good physical and mental health as evidenced by
250 documentary proof of having satisfactorily passed a physical
251 examination administered by a licensed physician or physician
252 assistant within each calendar year. The board shall adopt rules
253 to establish requirements for passing the physical examination,
254 which rules shall establish minimum standards for the physical
255 or mental capabilities necessary to carry out the professional
256 duties of a licensed state pilot or a certificated deputy pilot.
257 Such standards shall include zero tolerance for any controlled
258 substance regulated under chapter 893 unless that individual is
259 under the care of a physician, advanced registered nurse
260 practitioner, or physician assistant and that controlled
261 substance was prescribed by that physician, advanced registered
262 nurse practitioner, or physician assistant. To maintain
263 eligibility as a certificated deputy pilot or licensed state
264 pilot, each certificated deputy pilot or licensed state pilot
265 must annually provide documentary proof of having satisfactorily
266 passed a complete physical examination administered by a
267 licensed physician. The physician must know the minimum
268 standards and certify that the certificateholder or licensee
269 satisfactorily meets the standards. The standards for
270 certificateholders and for licensees shall include a drug test.
271
272 Upon resignation or in the case of disability permanently
273 affecting a pilot’s ability to serve, the state license or
274 certificate issued under this chapter shall be revoked by the
275 department.
276 Section 5. Section 383.336, Florida Statutes, is repealed.
277 Section 6. Section 395.1051, Florida Statutes, is amended
278 to read:
279 395.1051 Duty to notify patients and physicians.—
280 (1) An appropriately trained person designated by each
281 licensed facility shall inform each patient, or an individual
282 identified pursuant to s. 765.401(1), in person about adverse
283 incidents that result in serious harm to the patient.
284 Notification of outcomes of care that result in harm to the
285 patient under this section does shall not constitute an
286 acknowledgment or admission of liability and may not, nor can it
287 be introduced as evidence.
288 (2) A hospital shall notify each obstetrical physician who
289 has privileges at the hospital at least 90 days before the
290 hospital closes its obstetrical department or ceases to provide
291 obstetrical services.
292 Section 7. Paragraph (c) of subsection (2) of section
293 409.967, Florida Statutes, is amended to read:
294 409.967 Managed care plan accountability.—
295 (2) The agency shall establish such contract requirements
296 as are necessary for the operation of the statewide managed care
297 program. In addition to any other provisions the agency may deem
298 necessary, the contract must require:
299 (c) Access.—
300 1. The agency shall establish specific standards for the
301 number, type, and regional distribution of providers in managed
302 care plan networks to ensure access to care for both adults and
303 children. Each plan must maintain a regionwide network of
304 providers in sufficient numbers to meet the access standards for
305 specific medical services for all recipients enrolled in the
306 plan. The exclusive use of mail-order pharmacies may not be
307 sufficient to meet network access standards. Consistent with the
308 standards established by the agency, provider networks may
309 include providers located outside the region. A plan may
310 contract with a new hospital facility before the date the
311 hospital becomes operational if the hospital has commenced
312 construction, will be licensed and operational by January 1,
313 2013, and a final order has issued in any civil or
314 administrative challenge. Each plan shall establish and maintain
315 an accurate and complete electronic database of contracted
316 providers, including information about licensure or
317 registration, locations and hours of operation, specialty
318 credentials and other certifications, specific performance
319 indicators, and such other information as the agency deems
320 necessary. The database must be available online to both the
321 agency and the public and have the capability to compare the
322 availability of providers to network adequacy standards and to
323 accept and display feedback from each provider’s patients. Each
324 plan shall submit quarterly reports to the agency identifying
325 the number of enrollees assigned to each primary care provider.
326 2. Each managed care plan must publish any prescribed drug
327 formulary or preferred drug list on the plan’s website in a
328 manner that is accessible to and searchable by enrollees and
329 providers. The plan must update the list within 24 hours after
330 making a change. Each plan must ensure that the prior
331 authorization process for prescribed drugs is readily accessible
332 to health care providers, including posting appropriate contact
333 information on its website and providing timely responses to
334 providers. For Medicaid recipients diagnosed with hemophilia who
335 have been prescribed anti-hemophilic-factor replacement
336 products, the agency shall provide for those products and
337 hemophilia overlay services through the agency’s hemophilia
338 disease management program.
339 3. Managed care plans, and their fiscal agents or
340 intermediaries, must accept prior authorization requests for any
341 service electronically.
342 4. Managed care plans serving children in the care and
343 custody of the Department of Children and Families must maintain
344 complete medical, dental, and behavioral health encounter
345 information and participate in making such information available
346 to the department or the applicable contracted community-based
347 care lead agency for use in providing comprehensive and
348 coordinated case management. The agency and the department shall
349 establish an interagency agreement to provide guidance for the
350 format, confidentiality, recipient, scope, and method of
351 information to be made available and the deadlines for
352 submission of the data. The scope of information available to
353 the department shall be the data that managed care plans are
354 required to submit to the agency. The agency shall determine the
355 plan’s compliance with standards for access to medical, dental,
356 and behavioral health services; the use of medications; and
357 followup on all medically necessary services recommended as a
358 result of early and periodic screening, diagnosis, and
359 treatment.
360 5. If medication for the treatment of a medical condition
361 is restricted for use by a managed care plan through a step
362 therapy or fail-first protocol, the prescribing provider shall
363 have access to a clear and convenient process to request an
364 override of such restriction from the managed care plan. The
365 managed care plan shall grant an override of the protocol within
366 24 hours if:
367 a. The prescribing provider determines, based on sound
368 clinical evidence, that the preferred treatment required under
369 the step-therapy or fail-first protocol has been ineffective in
370 the treatment of the enrollee’s disease or medical condition; or
371 b. The prescribing provider believes, based on sound
372 clinical evidence or medical and scientific evidence, that the
373 preferred treatment required under the step-therapy or fail
374 first protocol:
375 (I) Is expected to, or is likely to, be ineffective given
376 the known relevant physical or mental characteristics and
377 medical history of the enrollee and the known characteristics of
378 the drug regimen; or
379 (II) Will cause, or is likely to cause, an adverse reaction
380 or other physical harm to the enrollee.
381 6. If the prescribing provider allows the enrollee to enter
382 the step-therapy or fail-first protocol recommended by the
383 managed care plan, the duration of the step-therapy or fail
384 first protocol may not exceed a period deemed appropriate by the
385 prescribing provider. If the prescribing provider deems the
386 treatment clinically ineffective, the enrollee is entitled to
387 receive the recommended course of therapy without requiring the
388 prescribing provider to seek approval for an override of the
389 step-therapy or fail-first protocol.
390 Section 8. Subsection (7) of section 456.072, Florida
391 Statutes, is amended to read:
392 456.072 Grounds for discipline; penalties; enforcement.—
393 (7) Notwithstanding subsection (2), upon a finding that a
394 physician has prescribed or dispensed a controlled substance, or
395 caused a controlled substance to be prescribed or dispensed, in
396 a manner that violates the standard of practice set forth in s.
397 458.331(1)(q) or (t), s. 459.015(1)(t) or (x), s. 461.013(1)(o)
398 or (s), or s. 466.028(1)(p) or (x), or that an advanced
399 registered nurse practitioner has prescribed or dispensed a
400 controlled substance, or caused a controlled substance to be
401 prescribed or dispensed in a manner that violates the standard
402 of practice set forth in s. 464.018(1)(n) or s. 464.018(1)(p)6.,
403 the physician or advanced registered nurse practitioner shall be
404 suspended for a period of not less than 6 months and pay a fine
405 of not less than $10,000 per count. Repeated violations shall
406 result in increased penalties.
407 Section 9. Subsections (2) and (3) of section 456.44,
408 Florida Statutes, are amended to read:
409 456.44 Controlled substance prescribing.—
410 (2) REGISTRATION.—Effective January 1, 2012, A physician
411 licensed under chapter 458, chapter 459, chapter 461, or chapter
412 466, a physician assistant licensed under chapter 458 or chapter
413 459, or an advanced registered nurse practitioner certified
414 under part I of chapter 464 who prescribes any controlled
415 substance, listed in Schedule II, Schedule III, or Schedule IV
416 as defined in s. 893.03, for the treatment of chronic
417 nonmalignant pain, must:
418 (a) Designate himself or herself as a controlled substance
419 prescribing practitioner on his or her the physician’s
420 practitioner profile.
421 (b) Comply with the requirements of this section and
422 applicable board rules.
423 (3) STANDARDS OF PRACTICE.—The standards of practice in
424 this section do not supersede the level of care, skill, and
425 treatment recognized in general law related to health care
426 licensure.
427 (a) A complete medical history and a physical examination
428 must be conducted before beginning any treatment and must be
429 documented in the medical record. The exact components of the
430 physical examination shall be left to the judgment of the
431 registrant clinician who is expected to perform a physical
432 examination proportionate to the diagnosis that justifies a
433 treatment. The medical record must, at a minimum, document the
434 nature and intensity of the pain, current and past treatments
435 for pain, underlying or coexisting diseases or conditions, the
436 effect of the pain on physical and psychological function, a
437 review of previous medical records, previous diagnostic studies,
438 and history of alcohol and substance abuse. The medical record
439 shall also document the presence of one or more recognized
440 medical indications for the use of a controlled substance. Each
441 registrant must develop a written plan for assessing each
442 patient’s risk of aberrant drug-related behavior, which may
443 include patient drug testing. Registrants must assess each
444 patient’s risk for aberrant drug-related behavior and monitor
445 that risk on an ongoing basis in accordance with the plan.
446 (b) Each registrant must develop a written individualized
447 treatment plan for each patient. The treatment plan shall state
448 objectives that will be used to determine treatment success,
449 such as pain relief and improved physical and psychosocial
450 function, and shall indicate if any further diagnostic
451 evaluations or other treatments are planned. After treatment
452 begins, the registrant physician shall adjust drug therapy to
453 the individual medical needs of each patient. Other treatment
454 modalities, including a rehabilitation program, shall be
455 considered depending on the etiology of the pain and the extent
456 to which the pain is associated with physical and psychosocial
457 impairment. The interdisciplinary nature of the treatment plan
458 shall be documented.
459 (c) The registrant physician shall discuss the risks and
460 benefits of the use of controlled substances, including the
461 risks of abuse and addiction, as well as physical dependence and
462 its consequences, with the patient, persons designated by the
463 patient, or the patient’s surrogate or guardian if the patient
464 is incompetent. The registrant physician shall use a written
465 controlled substance agreement between the registrant physician
466 and the patient outlining the patient’s responsibilities,
467 including, but not limited to:
468 1. Number and frequency of controlled substance
469 prescriptions and refills.
470 2. Patient compliance and reasons for which drug therapy
471 may be discontinued, such as a violation of the agreement.
472 3. An agreement that controlled substances for the
473 treatment of chronic nonmalignant pain shall be prescribed by a
474 single treating registrant physician unless otherwise authorized
475 by the treating registrant physician and documented in the
476 medical record.
477 (d) The patient shall be seen by the registrant physician
478 at regular intervals, not to exceed 3 months, to assess the
479 efficacy of treatment, ensure that controlled substance therapy
480 remains indicated, evaluate the patient’s progress toward
481 treatment objectives, consider adverse drug effects, and review
482 the etiology of the pain. Continuation or modification of
483 therapy shall depend on the registrant’s physician’s evaluation
484 of the patient’s progress. If treatment goals are not being
485 achieved, despite medication adjustments, the registrant
486 physician shall reevaluate the appropriateness of continued
487 treatment. The registrant physician shall monitor patient
488 compliance in medication usage, related treatment plans,
489 controlled substance agreements, and indications of substance
490 abuse or diversion at a minimum of 3-month intervals.
491 (e) The registrant physician shall refer the patient as
492 necessary for additional evaluation and treatment in order to
493 achieve treatment objectives. Special attention shall be given
494 to those patients who are at risk for misusing their medications
495 and those whose living arrangements pose a risk for medication
496 misuse or diversion. The management of pain in patients with a
497 history of substance abuse or with a comorbid psychiatric
498 disorder requires extra care, monitoring, and documentation and
499 requires consultation with or referral to an addiction medicine
500 specialist or psychiatrist.
501 (f) A registrant physician registered under this section
502 must maintain accurate, current, and complete records that are
503 accessible and readily available for review and comply with the
504 requirements of this section, the applicable practice act, and
505 applicable board rules. The medical records must include, but
506 are not limited to:
507 1. The complete medical history and a physical examination,
508 including history of drug abuse or dependence.
509 2. Diagnostic, therapeutic, and laboratory results.
510 3. Evaluations and consultations.
511 4. Treatment objectives.
512 5. Discussion of risks and benefits.
513 6. Treatments.
514 7. Medications, including date, type, dosage, and quantity
515 prescribed.
516 8. Instructions and agreements.
517 9. Periodic reviews.
518 10. Results of any drug testing.
519 11. A photocopy of the patient’s government-issued photo
520 identification.
521 12. If a written prescription for a controlled substance is
522 given to the patient, a duplicate of the prescription.
523 13. The registrant’s physician’s full name presented in a
524 legible manner.
525 (g) Patients with signs or symptoms of substance abuse
526 shall be immediately referred to a board-certified pain
527 management physician, an addiction medicine specialist, or a
528 mental health addiction facility as it pertains to drug abuse or
529 addiction unless the registrant is a physician who is board
530 certified or board-eligible in pain management. Throughout the
531 period of time before receiving the consultant’s report, a
532 prescribing registrant physician shall clearly and completely
533 document medical justification for continued treatment with
534 controlled substances and those steps taken to ensure medically
535 appropriate use of controlled substances by the patient. Upon
536 receipt of the consultant’s written report, the prescribing
537 registrant physician shall incorporate the consultant’s
538 recommendations for continuing, modifying, or discontinuing
539 controlled substance therapy. The resulting changes in treatment
540 shall be specifically documented in the patient’s medical
541 record. Evidence or behavioral indications of diversion shall be
542 followed by discontinuation of controlled substance therapy, and
543 the patient shall be discharged, and all results of testing and
544 actions taken by the registrant physician shall be documented in
545 the patient’s medical record.
546
547 This subsection does not apply to a board-eligible or board
548 certified anesthesiologist, physiatrist, rheumatologist, or
549 neurologist, or to a board-certified physician who has surgical
550 privileges at a hospital or ambulatory surgery center and
551 primarily provides surgical services. This subsection does not
552 apply to a board-eligible or board-certified medical specialist
553 who has also completed a fellowship in pain medicine approved by
554 the Accreditation Council for Graduate Medical Education or the
555 American Osteopathic Association, or who is board eligible or
556 board certified in pain medicine by the American Board of Pain
557 Medicine, the American Board of Interventional Pain Physicians,
558 the American Association of Physician Specialists, or a board
559 approved by the American Board of Medical Specialties or the
560 American Osteopathic Association and performs interventional
561 pain procedures of the type routinely billed using surgical
562 codes. This subsection does not apply to a registrant, advanced
563 registered nurse practitioner, or physician assistant who
564 prescribes medically necessary controlled substances for a
565 patient during an inpatient stay in a hospital licensed under
566 chapter 395.
567 Section 10. Section 458.326, Florida Statutes, is amended
568 to read:
569 458.326 Intractable pain; authorized treatment;
570 interventional pain medicine; unauthorized practice.—
571 (1)(a) For the purposes of this subsection section, the
572 term “intractable pain” means pain for which, in the generally
573 accepted course of medical practice, the cause cannot be removed
574 and otherwise treated.
575 (b)(2) Intractable pain must be diagnosed by a physician
576 licensed under this chapter and qualified by experience to
577 render such diagnosis.
578 (c)(3) Notwithstanding any other provision of law, a
579 physician may prescribe or administer any controlled substance
580 under Schedules II-V, as provided for in s. 893.03, to a person
581 for the treatment of intractable pain, provided the physician
582 does so in accordance with that level of care, skill, and
583 treatment recognized by a reasonably prudent physician under
584 similar conditions and circumstances.
585 (d)(4) Nothing in this section shall be construed to
586 condone, authorize, or approve mercy killing or euthanasia, and
587 no treatment authorized by this section may be used for such
588 purpose.
589 (2)(a) For the purposes of this subsection, the term
590 “interventional pain medicine” means the practice of medicine
591 devoted to the diagnosis and treatment of pain-related
592 disorders, principally with the application of interventional
593 techniques in managing chronic, intractable pain, independently
594 or in conjunction with other treatment modalities. These
595 techniques include minimally invasive procedures, including
596 percutaneous precision needle placement, with placement of drugs
597 in targeted areas or destruction of targeted nerves, and some
598 surgical techniques such as laser or endoscopic discectomy,
599 cement stabilization of spine fractures, intrathecal infusion
600 pumps, and spinal cord stimulators, for the diagnosis and
601 management of chronic, intractable pain.
602 (b) A person may not practice interventional pain medicine
603 or offer to practice interventional pain medicine unless such
604 acts are performed at facilities licensed under chapter 395 or
605 are performed by or under the direct supervision of a physician
606 licensed under this chapter or an osteopathic physician licensed
607 under chapter 459.
608 Section 11. Paragraph (b) of subsection (2) of section
609 458.3265, Florida Statutes, is amended to read:
610 458.3265 Pain-management clinics.—
611 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
612 apply to any physician who provides professional services in a
613 pain-management clinic that is required to be registered in
614 subsection (1).
615 (b) A person may not dispense any medication on the
616 premises of a registered pain-management clinic unless he or she
617 is a physician licensed under this chapter or chapter 459. A
618 person may not prescribe any controlled substance regulated
619 under chapter 893 on the premises of a registered pain
620 management clinic unless he or she is a physician licensed under
621 this chapter or chapter 459.
622 Section 12. Paragraph (b) of subsection (2) of section
623 459.0137, Florida Statutes, is amended to read:
624 459.0137 Pain-management clinics.—
625 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
626 apply to any osteopathic physician who provides professional
627 services in a pain-management clinic that is required to be
628 registered in subsection (1).
629 (b) A person may not dispense any medication on the
630 premises of a registered pain-management clinic unless he or she
631 is a physician licensed under this chapter or chapter 458. A
632 person may not prescribe any controlled substance regulated
633 under chapter 893 on the premises of a registered pain
634 management clinic unless he or she is a physician licensed under
635 this chapter or chapter 458.
636 Section 13. Paragraph (e) of subsection (4) of section
637 458.347, Florida Statutes, is amended, and paragraph (c) of
638 subsection (9) of that section is republished, to read:
639 458.347 Physician assistants.—
640 (4) PERFORMANCE OF PHYSICIAN ASSISTANTS.—
641 (e) A supervisory physician may delegate to a fully
642 licensed physician assistant the authority to prescribe or
643 dispense any medication used in the supervisory physician’s
644 practice unless such medication is listed on the formulary
645 created pursuant to paragraph (f). A fully licensed physician
646 assistant may only prescribe or dispense such medication under
647 the following circumstances:
648 1. A physician assistant must clearly identify to the
649 patient that he or she is a physician assistant. Furthermore,
650 the physician assistant must inform the patient that the patient
651 has the right to see the physician prior to any prescription
652 being prescribed or dispensed by the physician assistant.
653 2. The supervisory physician must notify the department of
654 his or her intent to delegate, on a department-approved form,
655 before delegating such authority and notify the department of
656 any change in prescriptive privileges of the physician
657 assistant. Authority to dispense may be delegated only by a
658 supervising physician who is registered as a dispensing
659 practitioner in compliance with s. 465.0276.
660 3. The physician assistant must file with the department a
661 signed affidavit that he or she has completed a minimum of 10
662 continuing medical education hours in the specialty practice in
663 which the physician assistant has prescriptive privileges with
664 each licensure renewal application. Three of the 10 hours must
665 consist of a continuing education course on the safe and
666 effective prescribing of controlled substance medications, which
667 shall be offered by a statewide professional association of
668 physicians in this state accredited to provide educational
669 activities designated for the American Medical Association
670 Physician’s Recognition Award Category I Credit.
671 4. The department may issue a prescriber number to the
672 physician assistant granting authority for the prescribing of
673 medicinal drugs authorized within this paragraph upon completion
674 of the foregoing requirements. The physician assistant shall not
675 be required to independently register pursuant to s. 465.0276.
676 5. The prescription must be written in a form that complies
677 with chapter 499 and must contain, in addition to the
678 supervisory physician’s name, address, and telephone number, the
679 physician assistant’s prescriber number. Unless it is a drug or
680 drug sample dispensed by the physician assistant, the
681 prescription must be filled in a pharmacy permitted under
682 chapter 465 and must be dispensed in that pharmacy by a
683 pharmacist licensed under chapter 465. The appearance of the
684 prescriber number creates a presumption that the physician
685 assistant is authorized to prescribe the medicinal drug and the
686 prescription is valid.
687 6. The physician assistant must note the prescription or
688 dispensing of medication in the appropriate medical record.
689 (9) COUNCIL ON PHYSICIAN ASSISTANTS.—The Council on
690 Physician Assistants is created within the department.
691 (c) The council shall:
692 1. Recommend to the department the licensure of physician
693 assistants.
694 2. Develop all rules regulating the use of physician
695 assistants by physicians under this chapter and chapter 459,
696 except for rules relating to the formulary developed under
697 paragraph (4)(f). The council shall also develop rules to ensure
698 that the continuity of supervision is maintained in each
699 practice setting. The boards shall consider adopting a proposed
700 rule developed by the council at the regularly scheduled meeting
701 immediately following the submission of the proposed rule by the
702 council. A proposed rule submitted by the council may not be
703 adopted by either board unless both boards have accepted and
704 approved the identical language contained in the proposed rule.
705 The language of all proposed rules submitted by the council must
706 be approved by both boards pursuant to each respective board’s
707 guidelines and standards regarding the adoption of proposed
708 rules. If either board rejects the council’s proposed rule, that
709 board must specify its objection to the council with
710 particularity and include any recommendations it may have for
711 the modification of the proposed rule.
712 3. Make recommendations to the boards regarding all matters
713 relating to physician assistants.
714 4. Address concerns and problems of practicing physician
715 assistants in order to improve safety in the clinical practices
716 of licensed physician assistants.
717 Section 14. Effective January 1, 2016, paragraph (f) of
718 subsection (4) of section 458.347, Florida Statutes, is amended
719 to read:
720 458.347 Physician assistants.—
721 (4) PERFORMANCE OF PHYSICIAN ASSISTANTS.—
722 (f)1. The council shall establish a formulary of medicinal
723 drugs that a fully licensed physician assistant having
724 prescribing authority under this section or s. 459.022 may not
725 prescribe. The formulary must include controlled substances as
726 defined in chapter 893, general anesthetics, and radiographic
727 contrast materials, and must limit the prescription of Schedule
728 II controlled substances as defined in s. 893.03 to a 7-day
729 supply. The formulary must also restrict the prescribing of
730 psychiatric mental health controlled substances for children
731 under 18 years of age.
732 2. In establishing the formulary, the council shall consult
733 with a pharmacist licensed under chapter 465, but not licensed
734 under this chapter or chapter 459, who shall be selected by the
735 State Surgeon General.
736 3. Only the council shall add to, delete from, or modify
737 the formulary. Any person who requests an addition, deletion, or
738 modification of a medicinal drug listed on such formulary has
739 the burden of proof to show cause why such addition, deletion,
740 or modification should be made.
741 4. The boards shall adopt the formulary required by this
742 paragraph, and each addition, deletion, or modification to the
743 formulary, by rule. Notwithstanding any provision of chapter 120
744 to the contrary, the formulary rule shall be effective 60 days
745 after the date it is filed with the Secretary of State. Upon
746 adoption of the formulary, the department shall mail a copy of
747 such formulary to each fully licensed physician assistant having
748 prescribing authority under this section or s. 459.022, and to
749 each pharmacy licensed by the state. The boards shall establish,
750 by rule, a fee not to exceed $200 to fund the provisions of this
751 paragraph and paragraph (e).
752 Section 15. Subsection (2) of section 464.003, Florida
753 Statutes, is amended to read:
754 464.003 Definitions.—As used in this part, the term:
755 (2) “Advanced or specialized nursing practice” means, in
756 addition to the practice of professional nursing, the
757 performance of advanced-level nursing acts approved by the board
758 which, by virtue of postbasic specialized education, training,
759 and experience, are appropriately performed by an advanced
760 registered nurse practitioner. Within the context of advanced or
761 specialized nursing practice, the advanced registered nurse
762 practitioner may perform acts of nursing diagnosis and nursing
763 treatment of alterations of the health status. The advanced
764 registered nurse practitioner may also perform acts of medical
765 diagnosis and treatment, prescription, and operation as
766 authorized within the framework of an established supervisory
767 protocol which are identified and approved by a joint committee
768 composed of three members appointed by the Board of Nursing, two
769 of whom must be advanced registered nurse practitioners; three
770 members appointed by the Board of Medicine, two of whom must
771 have had work experience with advanced registered nurse
772 practitioners; and the State Surgeon General or the State
773 Surgeon General’s designee. Each committee member appointed by a
774 board shall be appointed to a term of 4 years unless a shorter
775 term is required to establish or maintain staggered terms. The
776 Board of Nursing shall adopt rules authorizing the performance
777 of any such acts approved by the joint committee. Unless
778 otherwise specified by the joint committee, such acts must be
779 performed under the general supervision of a practitioner
780 licensed under chapter 458, chapter 459, or chapter 466 within
781 the framework of standing protocols which identify the medical
782 acts to be performed and the conditions for their performance.
783 The department may, by rule, require that a copy of the protocol
784 be filed with the department along with the notice required by
785 s. 458.348.
786 Section 16. Subsection (6) is added to section 464.012,
787 Florida Statutes, to read:
788 464.012 Certification of advanced registered nurse
789 practitioners; fees; controlled substance prescribing.—
790 (6)(a) The board shall establish a committee to recommend a
791 formulary of controlled substances that an advanced registered
792 nurse practitioner may not prescribe or may prescribe only for
793 specific uses or in limited quantities. The committee must
794 consist of three advanced registered nurse practitioners
795 licensed under s. 464.012, recommended by the Board of Nursing;
796 three physicians licensed under chapter 458 or chapter 459 who
797 have had work experience with advanced registered nurse
798 practitioners, recommended by the Board of Medicine; and a
799 pharmacist licensed under chapter 465 who holds a Doctor of
800 Pharmacy degree, recommended by the Board of Pharmacy. The
801 committee may recommend an evidence-based formulary applicable
802 to all advanced registered nurse practitioners, which is limited
803 by specially certification or to approved uses of controlled
804 substances, or subject to other similar restrictions the
805 committee finds are necessary to protect the health, safety, and
806 welfare of the public. The formulary must restrict the
807 prescribing of psychiatric mental health controlled substances
808 for children under 18 years of age to psychiatric nurses as
809 defined in s. 394.455. The formulary must also limit the
810 prescribing of Schedule II controlled substances as defined in
811 s. 893.03 to a 7-day supply, except that such restriction does
812 not apply to controlled substances that are psychiatric
813 medications prescribed by psychiatric nurses as defined in s.
814 394.455.
815 (b) The board shall adopt by rule the recommended formulary
816 and recommended additions or deletions to the formulary which it
817 finds are supported by evidence-based clinical findings
818 presented by the Board of Medicine, the Board of Osteopathic
819 Medicine, or the Board of Dentistry.
820 (c) The formulary required under this subsection does not
821 apply to a controlled substance order that is dispensed for
822 administration including orders for medication authorized in
823 subparagraph (4)(a)3. or subparagraph (4)(a)4.
824 (d) The board shall adopt the committee’s initial
825 recommendation no later January 1, 2016.
826 Section 17. Effective January 1, 2016, subsection (3) of
827 section 464.012, Florida Statutes, is amended to read:
828 464.012 Certification of advanced registered nurse
829 practitioners; fees; controlled substance prescribing.—
830 (3) An advanced registered nurse practitioner shall perform
831 those functions authorized in this section within the framework
832 of an established protocol that is filed with the board upon
833 biennial license renewal and within 30 days after entering into
834 a supervisory relationship with a physician or changes to the
835 protocol. The board shall review the protocol to ensure
836 compliance with applicable regulatory standards for protocols.
837 The board shall refer to the department licensees submitting
838 protocols that are not compliant with the regulatory standards
839 for protocols. A practitioner currently licensed under chapter
840 458, chapter 459, or chapter 466 shall maintain supervision for
841 directing the specific course of medical treatment. Within the
842 established framework, an advanced registered nurse practitioner
843 may:
844 (a) Prescribe, dispense, administer, or order any drug;
845 however, an advanced registered nurse practitioner may only
846 prescribe or dispense a controlled substance as defined in s.
847 893.03 if the advanced registered nurse practitioner has
848 graduated from a program leading to a master’s degree in a
849 clinical nursing specialty area with training in specialized
850 practitioner skills. Monitor and alter drug therapies.
851 (b) Initiate appropriate therapies for certain conditions.
852 (c) Perform additional functions as may be determined by
853 rule in accordance with s. 464.003(2).
854 (d) Order diagnostic tests and physical and occupational
855 therapy.
856 Section 18. Subsection (3) of section 464.013, Florida
857 Statutes, is amended to read:
858 464.013 Renewal of license or certificate.—
859 (3) The board shall by rule prescribe up to 30 hours of
860 continuing education biennially as a condition for renewal of a
861 license or certificate.
862 (a) A nurse who is certified by a health care specialty
863 program accredited by the National Commission for Certifying
864 Agencies or the Accreditation Board for Specialty Nursing
865 Certification is exempt from continuing education requirements.
866 The criteria for programs must shall be approved by the board.
867 (b) Notwithstanding the exemption in paragraph (a), as part
868 of the maximum 30 hours of continuing education hours required
869 under this subsection, advanced registered nurse practitioners
870 certified under s. 464.012 must complete at least 3 hours of
871 continuing education on the safe and effective prescription of
872 controlled substances. Such continuing education courses must be
873 offered by a statewide professional association of physicians in
874 this state accredited to provide educational activities
875 designated for the American Medical Association Physician’s
876 Recognition Award Category 1 Credit, the American Nurses
877 Credentialing Center, or the American Association of Nurse
878 Practitioners and may be offered in a distance-learning format.
879 Section 19. Paragraph (p) is added to subsection (1) of
880 section 464.018, Florida Statutes, and subsection (2) of that
881 section is republished, to read:
882 464.018 Disciplinary actions.—
883 (1) The following acts constitute grounds for denial of a
884 license or disciplinary action, as specified in s. 456.072(2):
885 (p) For an advanced registered nurse practitioner:
886 1. Presigning blank prescription forms.
887 2. Prescribing for office use any medicinal drug appearing
888 on Schedule II in chapter 893.
889 3. Prescribing, ordering, dispensing, administering,
890 supplying, selling, or giving a drug that is an amphetamine or a
891 sympathomimetic amine drug, or a compound designated pursuant to
892 chapter 893 as a Schedule II controlled substance, to or for any
893 person except for:
894 a. The treatment of narcolepsy; hyperkinesis; behavioral
895 syndrome in children characterized by the developmentally
896 inappropriate symptoms of moderate to severe distractibility,
897 short attention span, hyperactivity, emotional lability, and
898 impulsivity; or drug-induced brain dysfunction.
899 b. The differential diagnostic psychiatric evaluation of
900 depression or the treatment of depression shown to be refractory
901 to other therapeutic modalities.
902 c. The clinical investigation of the effects of such drugs
903 or compounds when an investigative protocol is submitted to,
904 reviewed by, and approved by the department before such
905 investigation is begun.
906 4. Prescribing, ordering, dispensing, administering,
907 supplying, selling, or giving growth hormones, testosterone or
908 its analogs, human chorionic gonadotropin (HCG), or other
909 hormones for the purpose of muscle building or to enhance
910 athletic performance. As used in this subparagraph, the term
911 “muscle building” does not include the treatment of injured
912 muscle. A prescription written for the drug products listed in
913 this paragraph may be dispensed by a pharmacist with the
914 presumption that the prescription is for legitimate medical use.
915 5. Promoting or advertising on any prescription form a
916 community pharmacy unless the form also states: “This
917 prescription may be filled at any pharmacy of your choice.”
918 6. Prescribing, dispensing, administering, mixing, or
919 otherwise preparing a legend drug, including a controlled
920 substance, other than in the course of his or her professional
921 practice. For the purposes of this subparagraph, it is legally
922 presumed that prescribing, dispensing, administering, mixing, or
923 otherwise preparing legend drugs, including all controlled
924 substances, inappropriately or in excessive or inappropriate
925 quantities is not in the best interest of the patient and is not
926 in the course of the advanced registered nurse practitioner’s
927 professional practice, without regard to his or her intent.
928 7. Prescribing, dispensing, or administering a medicinal
929 drug appearing on any schedule set forth in chapter 893 to
930 himself or herself, except a drug prescribed, dispensed, or
931 administered to the advanced registered nurse practitioner by
932 another practitioner authorized to prescribe, dispense, or
933 administer medicinal drugs.
934 8. Prescribing, ordering, dispensing, administering,
935 supplying, selling, or giving amygdalin (laetrile) to any
936 person.
937 9. Dispensing a controlled substance listed on Schedule II
938 or Schedule III in chapter 893 in violation of s. 465.0276.
939 10. Promoting or advertising through any communication
940 medium the use, sale, or dispensing of a controlled substance
941 appearing on any schedule in chapter 893.
942 (2) The board may enter an order denying licensure or
943 imposing any of the penalties in s. 456.072(2) against any
944 applicant for licensure or licensee who is found guilty of
945 violating any provision of subsection (1) of this section or who
946 is found guilty of violating any provision of s. 456.072(1).
947 Section 20. Section 627.42392, Florida Statutes, is created
948 to read:
949 627.42392 Prior authorization.—
950 (1) As used in this section, the term “health insurer”
951 means an authorized insurer offering health insurance as defined
952 in s. 624.603, a managed care plan as defined in s. 409.901(13),
953 or a health maintenance organization as defined in s.
954 641.19(12).
955 (2) Notwithstanding any other provision of law, in order to
956 establish uniformity in the submission of prior authorization
957 forms on or after January 1, 2016, a health insurer, or a
958 pharmacy benefits manager on behalf of the health insurer, which
959 does not use an online prior authorization form for its
960 contracted providers shall use only the prior authorization form
961 that has been approved by the Financial Services Commission to
962 obtain a prior authorization for a medical procedure, course of
963 treatment, or prescription drug benefit. Such form may not
964 exceed two pages in length, excluding any instructions or
965 guiding documentation.
966 (3) The Financial Services Commission shall adopt by rule
967 guidelines for prior authorization forms which ensure the
968 general uniformity of such forms.
969 Section 21. Subsection (11) of section 627.6131, Florida
970 Statutes, is amended to read:
971 627.6131 Payment of claims.—
972 (11) A health insurer may not retroactively deny a claim
973 because of insured ineligibility:
974 (a) At any time, if the health insurer verified the
975 eligibility of an insured at the time of treatment and provided
976 an authorization number.
977 (b) More than 1 year after the date of payment of the
978 claim.
979 Section 22. Section 627.6466, Florida Statutes, is created
980 to read:
981 627.6466 Fail-first protocols.—If medication for the
982 treatment of a medical condition is restricted for use by an
983 insurer through a step-therapy or fail-first protocol, the
984 prescribing provider shall have access to a clear and convenient
985 process to request an override of such restriction from the
986 insurer. The insurer shall grant an override of the protocol
987 within 24 hours under the following circumstances:
988 (1) The prescribing provider determines, based on sound
989 clinical evidence, that the preferred treatment required under
990 the step-therapy or fail-first protocol has been ineffective in
991 the treatment of the insured’s disease or medical condition; or
992 (2) The prescribing provider believes, based on sound
993 clinical evidence or medical and scientific evidence, that the
994 preferred treatment required under the step-therapy or fail
995 first protocol:
996 (a) Is expected to, or is likely to, be ineffective given
997 the known relevant physical or mental characteristics and
998 medical history of the insured and the known characteristics of
999 the drug regimen; or
1000 (b) Will cause, or is likely to cause, an adverse reaction
1001 or other physical harm to the insured.
1002 (3) If the prescribing provider allows the insured to enter
1003 the step-therapy or fail-first protocol recommended by the
1004 health insurer, the duration of the step-therapy or fail-first
1005 protocol may not exceed a period deemed appropriate by the
1006 provider. If the prescribing provider deems the treatment
1007 clinically ineffective, the insured is entitled to receive the
1008 recommended course of therapy without requiring the prescribing
1009 provider to seek approval for an override of the step-therapy or
1010 fail-first protocol.
1011 Section 23. Subsection (10) of section 641.3155, Florida
1012 Statutes, is amended to read:
1013 641.3155 Prompt payment of claims.—
1014 (10) A health maintenance organization may not
1015 retroactively deny a claim because of subscriber ineligibility:
1016 (a) At any time, if the health maintenance organization
1017 verified the eligibility of an insured at the time of treatment
1018 and provided an authorization number.
1019 (b) More than 1 year after the date of payment of the
1020 claim.
1021 Section 24. Section 641.393, Florida Statutes, is created
1022 to read:
1023 641.393 Fail-first protocols.—If medication for the
1024 treatment of a medical condition is restricted for use by a
1025 health maintenance organization through a step-therapy or fail
1026 first protocol, the prescribing provider shall have access to a
1027 clear and convenient process to request an override of such
1028 restriction from the organization. The health maintenance
1029 organization shall grant an override of the protocol within 24
1030 hours under the following circumstances:
1031 (1) The prescribing provider determines, based on sound
1032 clinical evidence, that the preferred treatment required under
1033 step-therapy or fail-first protocol has been ineffective in the
1034 treatment of the subscriber’s disease or medical condition; or
1035 (2) The prescribing provider believes, based on sound
1036 clinical evidence or medical and scientific evidence, that the
1037 preferred treatment required under the step-therapy or fail
1038 first protocol:
1039 (a) Is expected to, or is likely to, be ineffective given
1040 the known relevant physical or mental characteristics and
1041 medical history of the subscriber and the known characteristics
1042 of the drug regimen; or
1043 (b) Will cause, or is likely to cause, an adverse reaction
1044 or other physical harm to the subscriber.
1045 (3) If the prescribing provider allows the subscriber to
1046 enter the step-therapy or fail-first protocol recommended by the
1047 health maintenance organization, the duration of the step
1048 therapy or fail-first protocol may not exceed a period deemed
1049 appropriate by the provider. If the prescribing provider deems
1050 the treatment clinically ineffective, the subscriber is entitled
1051 to receive the recommended course of therapy without requiring
1052 the prescribing provider to seek approval for an override of the
1053 step-therapy or fail-first protocol.
1054 Section 25. Subsection (21) of section 893.02, Florida
1055 Statutes, is amended to read:
1056 893.02 Definitions.—The following words and phrases as used
1057 in this chapter shall have the following meanings, unless the
1058 context otherwise requires:
1059 (21) “Practitioner” means a physician licensed under
1060 pursuant to chapter 458, a dentist licensed under pursuant to
1061 chapter 466, a veterinarian licensed under pursuant to chapter
1062 474, an osteopathic physician licensed under pursuant to chapter
1063 459, an advanced registered nurse practitioner certified under
1064 chapter 464, a naturopath licensed under pursuant to chapter
1065 462, a certified optometrist licensed under pursuant to chapter
1066 463, or a podiatric physician licensed under pursuant to chapter
1067 461, or a physician assistant licensed under chapter 458 or
1068 chapter 459, provided such practitioner holds a valid federal
1069 controlled substance registry number.
1070 Section 26. Paragraph (n) of subsection (1) of section
1071 948.03, Florida Statutes, is amended to read:
1072 948.03 Terms and conditions of probation.—
1073 (1) The court shall determine the terms and conditions of
1074 probation. Conditions specified in this section do not require
1075 oral pronouncement at the time of sentencing and may be
1076 considered standard conditions of probation. These conditions
1077 may include among them the following, that the probationer or
1078 offender in community control shall:
1079 (n) Be prohibited from using intoxicants to excess or
1080 possessing any drugs or narcotics unless prescribed by a
1081 physician, advanced registered nurse practitioner, or physician
1082 assistant. The probationer or community controllee may shall not
1083 knowingly visit places where intoxicants, drugs, or other
1084 dangerous substances are unlawfully sold, dispensed, or used.
1085 Section 27. Paragraph (a) of subsection (1) and subsection
1086 (2) of section 458.348, Florida Statutes, are amended to read:
1087 458.348 Formal supervisory relationships, standing orders,
1088 and established protocols; notice; standards.—
1089 (1) NOTICE.—
1090 (a) When a physician enters into a formal supervisory
1091 relationship or standing orders with an emergency medical
1092 technician or paramedic licensed pursuant to s. 401.27, which
1093 relationship or orders contemplate the performance of medical
1094 acts, or when a physician enters into an established protocol
1095 with an advanced registered nurse practitioner, which protocol
1096 contemplates the performance of medical acts identified and
1097 approved by the joint committee pursuant to s. 464.003(2) or
1098 acts set forth in s. 464.012(3) and (4), the physician shall
1099 submit notice to the board. The notice shall contain a statement
1100 in substantially the following form:
1101
1102 I, ...(name and professional license number of
1103 physician)..., of ...(address of physician)... have hereby
1104 entered into a formal supervisory relationship, standing orders,
1105 or an established protocol with ...(number of persons)...
1106 emergency medical technician(s), ...(number of persons)...
1107 paramedic(s), or ...(number of persons)... advanced registered
1108 nurse practitioner(s).
1109
1110 (2) ESTABLISHMENT OF STANDARDS BY JOINT COMMITTEE.—The
1111 joint committee created under s. 464.003(2) shall determine
1112 minimum standards for the content of established protocols
1113 pursuant to which an advanced registered nurse practitioner may
1114 perform medical acts identified and approved by the joint
1115 committee pursuant to s. 464.003(2) or acts set forth in s.
1116 464.012(3) and (4) and shall determine minimum standards for
1117 supervision of such acts by the physician, unless the joint
1118 committee determines that any act set forth in s. 464.012(3) or
1119 (4) is not a medical act. Such standards shall be based on risk
1120 to the patient and acceptable standards of medical care and
1121 shall take into account the special problems of medically
1122 underserved areas. The standards developed by the joint
1123 committee shall be adopted as rules by the Board of Nursing and
1124 the Board of Medicine for purposes of carrying out their
1125 responsibilities pursuant to part I of chapter 464 and this
1126 chapter, respectively, but neither board shall have disciplinary
1127 powers over the licensees of the other board.
1128 Section 28. Paragraph (a) of subsection (1) of section
1129 459.025, Florida Statutes, is amended to read:
1130 459.025 Formal supervisory relationships, standing orders,
1131 and established protocols; notice; standards.—
1132 (1) NOTICE.—
1133 (a) When an osteopathic physician enters into a formal
1134 supervisory relationship or standing orders with an emergency
1135 medical technician or paramedic licensed pursuant to s. 401.27,
1136 which relationship or orders contemplate the performance of
1137 medical acts, or when an osteopathic physician enters into an
1138 established protocol with an advanced registered nurse
1139 practitioner, which protocol contemplates the performance of
1140 medical acts identified and approved by the joint committee
1141 pursuant to s. 464.003(2) or acts set forth in s. 464.012(3) and
1142 (4), the osteopathic physician shall submit notice to the board.
1143 The notice must contain a statement in substantially the
1144 following form:
1145
1146 I, ...(name and professional license number of osteopathic
1147 physician)..., of ...(address of osteopathic physician)... have
1148 hereby entered into a formal supervisory relationship, standing
1149 orders, or an established protocol with ...(number of
1150 persons)... emergency medical technician(s), ...(number of
1151 persons)... paramedic(s), or ...(number of persons)... advanced
1152 registered nurse practitioner(s).
1153 Section 29. Subsection (10) of s. 458.331, paragraph (g) of
1154 subsection (7) of s. 458.347, subsection (10) of s. 459.015,
1155 paragraph (f) of subsection (7) of s. 459.022, and paragraph (b)
1156 of subsection (5) of s. 465.0158, Florida Statutes, are
1157 reenacted for the purpose of incorporating the amendment made by
1158 this act to s. 456.072, Florida Statutes, in references thereto.
1159 Section 30. Paragraph (mm) of subsection (1) of s. 456.072
1160 and s. 466.02751, Florida Statutes, are reenacted for the
1161 purpose of incorporating the amendment made by this act to s.
1162 456.44, Florida Statutes, in references thereto.
1163 Section 31. Section 458.303, paragraph (b) of subsection
1164 (7) of s. 458.3475, paragraph (e) of subsection (4) and
1165 paragraph (c) of subsection (9) of s. 459.022, and paragraph (b)
1166 of subsection (7) of s. 459.023, Florida Statutes, are reenacted
1167 for the purpose of incorporating the amendment made by this act
1168 to s. 458.347, Florida Statutes, in references thereto.
1169 Section 32. Paragraph (c) of subsection (3) of s. 464.012,
1170 Florida Statutes, is reenacted for the purpose of incorporating
1171 the amendment made by this act to s. 464.003, Florida Statutes,
1172 in a reference thereto.
1173 Section 33. Paragraph (a) of subsection (1) of s. 456.041,
1174 subsections (1) and (2) of s. 458.348, and subsection (1) of s.
1175 459.025, Florida Statutes, are reenacted for the purpose of
1176 incorporating the amendment made by this act to s. 464.012,
1177 Florida Statutes, in references thereto.
1178 Section 34. Subsection (7) of s. 464.0205, Florida
1179 Statutes, is reenacted for the purpose of incorporating the
1180 amendment made by this act to s. 464.013, Florida Statutes, in a
1181 reference thereto.
1182 Section 35. Subsection (11) of s. 320.0848, subsection (2)
1183 of s. 464.008, subsection (5) of s. 464.009, and paragraph (b)
1184 of subsection (1), subsection (3), and paragraph (b) of
1185 subsection (4) of s. 464.0205, Florida Statutes, are reenacted
1186 for the purpose of incorporating the amendment made by this act
1187 to s. 464.018, Florida Statutes, in references thereto.
1188 Section 36. Section 775.051, Florida Statutes, is reenacted
1189 for the purpose of incorporating the amendment made by this act
1190 to s. 893.02, Florida Statutes, in a reference thereto.
1191 Section 37. Paragraph (a) of subsection (3) of s. 944.17,
1192 subsection (8) of s. 948.001, and paragraph (e) of subsection
1193 (1) of s. 948.101, Florida Statutes, are reenacted for the
1194 purpose of incorporating the amendment made by this act to s.
1195 948.03, Florida Statutes, in references thereto.
1196 Section 38. Except as otherwise expressly provided in this
1197 act, this act shall take effect upon becoming a law.