Bill Text: FL S0210 | 2016 | Regular Session | Introduced
Bill Title: Health Care
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2016-02-10 - Withdrawn from further consideration, companion bill(s) passed, see HB 423 (Ch. 2016-224), CS/HB 977 (Ch. 2016-231), SB 586 (Ch. 2016-113) [S0210 Detail]
Download: Florida-2016-S0210-Introduced.html
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 whichthatresult in harm to 261 the patient under this section doesshallnot constitute an 262 acknowledgment or admission of liability and may not, nor can it263 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 herthe physician’s334 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 registrantclinicianwho 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 registrantphysicianshall 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 registrantphysicianshall 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 registrantphysicianshall use a written 379 controlled substance agreement between the registrantphysician380 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 registrantphysicianunless otherwise authorized 389 by the treating registrantphysicianand documented in the 390 medical record. 391 (d) The patient shall be seen by the registrantphysician392 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’sphysician’sevaluation 398 of the patient’s progress. If treatment goals are not being 399 achieved, despite medication adjustments, the registrant 400physicianshall reevaluate the appropriateness of continued 401 treatment. The registrantphysicianshall 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 registrantphysicianshall 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 registrantphysicianregistered under this section416 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’sphysician’sfull name presented in a 438 legible manner. 439 (g) A registrant shall immediately refer patients with 440 signs or symptoms of substance abuseshall be immediately441referredto 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 registrantphysicianshall 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 452physicianshall 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 registrantphysicianshall 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) Onlya person may not dispense any medication on the490premises of a registered pain-management clinic unless he or she491isa 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) Onlya person may not dispense any medication on the503premises of a registered pain-management clinic unless he or she504isa 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 includecontrolled substances as599defined 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 protocolwhich are identified and approved by a joint committee641composed of three members appointed by the Board of Nursing, two642of whom must be advanced registered nurse practitioners; three643members appointed by the Board of Medicine, two of whom must644have had work experience with advanced registered nurse645practitioners; and the State Surgeon General or the State646Surgeon General’s designee.Each committee member appointed by a647board shall be appointed to a term of 4 years unless a shorter648term is required to establish or maintain staggered terms. The649Board of Nursing shall adopt rules authorizing the performance650of any such acts approved by the joint committee. Unless651otherwise specified by the joint committee, such acts must be652performed under the general supervision of a practitioner653licensed under chapter 458, chapter 459, or chapter 466 within654the framework of standing protocols which identify the medical655acts 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 drug848therapies.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 mustshallbe 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 1059pursuant tochapter 458, a dentist licensed underpursuant to1060 chapter 466, a veterinarian licensed underpursuant tochapter 1061 474, an osteopathic physician licensed underpursuant tochapter 1062 459, an advanced registered nurse practitioner certified under 1063 chapter 464, a naturopath licensed underpursuant tochapter 1064 462, a certified optometrist licensed underpursuant tochapter 1065 463,ora podiatric physician licensed underpursuant tochapter 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 mayshallnot 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 medicalacts identified and1096approved by the joint committee pursuant to s. 464.003(2) or1097 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 committeecreated 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 actsidentified and approved by the joint1114committee 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 actsidentified and approved by the joint committee1140pursuant 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.