Florida Senate - 2019 SB 1192
By Senator Bean
4-01299-19 20191192__
1 A bill to be entitled
2 An act relating to electronic prescribing; amending s.
3 456.42, F.S.; requiring all prescriptions to be
4 electronically generated and transmitted upon a
5 certain practitioner’s license renewal or by a
6 specified date; prohibiting electronic prescribing
7 from interfering with a patient’s freedom to choose a
8 pharmacy; providing restrictions for electronic
9 prescribing software; providing definitions;
10 authorizing electronic prescribing software to display
11 information regarding a payor’s formulary under
12 certain circumstances; amending ss. 409.91196,
13 409.912, 456.0392, 458.3265, 458.331, 458.347,
14 459.0137, 459.015, and 459.022, F.S.; conforming
15 provisions to changes made by the act; repealing ss.
16 456.43, 831.311, and 893.065, F.S., relating to
17 electronic prescribing for medicinal drugs, the
18 unlawful sale, manufacture, alteration, delivery,
19 uttering, or possession of counterfeit-resistant
20 prescription blanks for controlled substances, and
21 counterfeit-resistant prescription blanks for
22 controlled substances listed in Schedule II, Schedule
23 III, Schedule IV, or Schedule V, respectively;
24 providing an effective date.
25
26 Be It Enacted by the Legislature of the State of Florida:
27
28 Section 1. Section 456.42, Florida Statutes, is amended to
29 read:
30 456.42 Written Prescriptions for medicinal drugs.—
31 (1) Upon renewal of the health care practitioner’s license
32 or by July 1, 2021, whichever is earlier, a written prescription
33 for a medicinal drug issued by a health care practitioner
34 licensed by law to prescribe a medicinal such drug may only
35 electronically transmit prescriptions for such drugs must be
36 legibly printed or typed so as to be capable of being understood
37 by the pharmacist filling the prescription; must contain the
38 name of the prescribing practitioner, the name and strength of
39 the drug prescribed, the quantity of the drug prescribed, and
40 the directions for use of the drug; must be dated; and must be
41 signed by the prescribing practitioner on the day when issued.
42 However, A prescription that is electronically generated and
43 transmitted must contain the name of the prescribing
44 practitioner, the name and strength of the drug prescribed, the
45 quantity of the drug prescribed in numerical format, and the
46 directions for use of the drug and must contain the date and an
47 electronic signature, as defined in s. 668.003(4), be dated and
48 signed by the prescribing practitioner only on the day issued,
49 which signature may be in an electronic format as defined in s.
50 668.003(4).
51 (2) Electronic prescribing may not interfere with a
52 patient’s freedom to choose a pharmacy.
53 (3) Electronic prescribing software may not use any means
54 or permit any other person to use any means, including, but not
55 limited to, advertising, instant messaging, and pop-up ads, to
56 influence or attempt to influence through economic incentives or
57 otherwise the prescribing decision of a prescribing practitioner
58 or his or her agent at the point of care. Such means may not be
59 triggered by or in specific response to the input, selection, or
60 act of a prescribing practitioner or his or her agent in
61 prescribing a certain medicinal drug or directing a patient to a
62 certain pharmacy. For purposes of this subsection, the term:
63 (a) “Point of care” means the time at which a prescribing
64 practitioner or his or her agent prescribes any medicinal drug.
65 (b) “Prescribing decision” means a prescribing
66 practitioner’s or his or her agent’s decision to prescribe any
67 medicinal drug.
68 (4) Electronic prescribing software may display information
69 regarding a payor’s formulary if nothing is designed to preclude
70 or make more difficult the selection of any particular pharmacy
71 by a patient or the selection of a certain medicinal drug by a
72 prescribing practitioner or his or her agent.
73 (2) A written prescription for a controlled substance
74 listed in chapter 893 must have the quantity of the drug
75 prescribed in both textual and numerical formats, must be dated
76 in numerical, month/day/year format, or with the abbreviated
77 month written out, or the month written out in whole, and must
78 be either written on a standardized counterfeit-proof
79 prescription pad produced by a vendor approved by the department
80 or electronically prescribed as that term is used in s.
81 408.0611. As a condition of being an approved vendor, a
82 prescription pad vendor must submit a monthly report to the
83 department that, at a minimum, documents the number of
84 prescription pads sold and identifies the purchasers. The
85 department may, by rule, require the reporting of additional
86 information.
87 Section 2. Subsection (1) of section 409.91196, Florida
88 Statutes, is amended to read:
89 409.91196 Supplemental rebate agreements; public records
90 and public meetings exemption.—
91 (1) The rebate amount, percent of rebate, manufacturer’s
92 pricing, and supplemental rebate, and other trade secrets as
93 defined in s. 688.002 that the agency has identified for use in
94 negotiations, held by the Agency for Health Care Administration
95 under s. 409.912(5)(a)6. s. 409.912(5)(a)7. are confidential and
96 exempt from s. 119.07(1) and s. 24(a), Art. I of the State
97 Constitution.
98 Section 3. Paragraph (a) of subsection (5) of section
99 409.912, Florida Statutes, is amended to read:
100 409.912 Cost-effective purchasing of health care.—The
101 agency shall purchase goods and services for Medicaid recipients
102 in the most cost-effective manner consistent with the delivery
103 of quality medical care. To ensure that medical services are
104 effectively utilized, the agency may, in any case, require a
105 confirmation or second physician’s opinion of the correct
106 diagnosis for purposes of authorizing future services under the
107 Medicaid program. This section does not restrict access to
108 emergency services or poststabilization care services as defined
109 in 42 C.F.R. s. 438.114. Such confirmation or second opinion
110 shall be rendered in a manner approved by the agency. The agency
111 shall maximize the use of prepaid per capita and prepaid
112 aggregate fixed-sum basis services when appropriate and other
113 alternative service delivery and reimbursement methodologies,
114 including competitive bidding pursuant to s. 287.057, designed
115 to facilitate the cost-effective purchase of a case-managed
116 continuum of care. The agency shall also require providers to
117 minimize the exposure of recipients to the need for acute
118 inpatient, custodial, and other institutional care and the
119 inappropriate or unnecessary use of high-cost services. The
120 agency shall contract with a vendor to monitor and evaluate the
121 clinical practice patterns of providers in order to identify
122 trends that are outside the normal practice patterns of a
123 provider’s professional peers or the national guidelines of a
124 provider’s professional association. The vendor must be able to
125 provide information and counseling to a provider whose practice
126 patterns are outside the norms, in consultation with the agency,
127 to improve patient care and reduce inappropriate utilization.
128 The agency may mandate prior authorization, drug therapy
129 management, or disease management participation for certain
130 populations of Medicaid beneficiaries, certain drug classes, or
131 particular drugs to prevent fraud, abuse, overuse, and possible
132 dangerous drug interactions. The Pharmaceutical and Therapeutics
133 Committee shall make recommendations to the agency on drugs for
134 which prior authorization is required. The agency shall inform
135 the Pharmaceutical and Therapeutics Committee of its decisions
136 regarding drugs subject to prior authorization. The agency is
137 authorized to limit the entities it contracts with or enrolls as
138 Medicaid providers by developing a provider network through
139 provider credentialing. The agency may competitively bid single
140 source-provider contracts if procurement of goods or services
141 results in demonstrated cost savings to the state without
142 limiting access to care. The agency may limit its network based
143 on the assessment of beneficiary access to care, provider
144 availability, provider quality standards, time and distance
145 standards for access to care, the cultural competence of the
146 provider network, demographic characteristics of Medicaid
147 beneficiaries, practice and provider-to-beneficiary standards,
148 appointment wait times, beneficiary use of services, provider
149 turnover, provider profiling, provider licensure history,
150 previous program integrity investigations and findings, peer
151 review, provider Medicaid policy and billing compliance records,
152 clinical and medical record audits, and other factors. Providers
153 are not entitled to enrollment in the Medicaid provider network.
154 The agency shall determine instances in which allowing Medicaid
155 beneficiaries to purchase durable medical equipment and other
156 goods is less expensive to the Medicaid program than long-term
157 rental of the equipment or goods. The agency may establish rules
158 to facilitate purchases in lieu of long-term rentals in order to
159 protect against fraud and abuse in the Medicaid program as
160 defined in s. 409.913. The agency may seek federal waivers
161 necessary to administer these policies.
162 (5)(a) The agency shall implement a Medicaid prescribed
163 drug spending-control program that includes the following
164 components:
165 1. A Medicaid preferred drug list, which shall be a listing
166 of cost-effective therapeutic options recommended by the
167 Medicaid Pharmacy and Therapeutics Committee established
168 pursuant to s. 409.91195 and adopted by the agency for each
169 therapeutic class on the preferred drug list. At the discretion
170 of the committee, and when feasible, the preferred drug list
171 should include at least two products in a therapeutic class. The
172 agency may post the preferred drug list and updates to the list
173 on an Internet website without following the rulemaking
174 procedures of chapter 120. Antiretroviral agents are excluded
175 from the preferred drug list. The agency shall also limit the
176 amount of a prescribed drug dispensed to no more than a 34-day
177 supply unless the drug products’ smallest marketed package is
178 greater than a 34-day supply, or the drug is determined by the
179 agency to be a maintenance drug in which case a 100-day maximum
180 supply may be authorized. The agency may seek any federal
181 waivers necessary to implement these cost-control programs and
182 to continue participation in the federal Medicaid rebate
183 program, or alternatively to negotiate state-only manufacturer
184 rebates. The agency may adopt rules to administer this
185 subparagraph. The agency shall continue to provide unlimited
186 contraceptive drugs and items. The agency must establish
187 procedures to ensure that:
188 a. There is a response to a request for prior consultation
189 by telephone or other telecommunication device within 24 hours
190 after receipt of a request for prior consultation; and
191 b. A 72-hour supply of the drug prescribed is provided in
192 an emergency or when the agency does not provide a response
193 within 24 hours as required by sub-subparagraph a.
194 2. Reimbursement to pharmacies for Medicaid prescribed
195 drugs shall be set at the lowest of: the average wholesale price
196 (AWP) minus 16.4 percent, the wholesaler acquisition cost (WAC)
197 plus 1.5 percent, the federal upper limit (FUL), the state
198 maximum allowable cost (SMAC), or the usual and customary (UAC)
199 charge billed by the provider.
200 3. The agency shall develop and implement a process for
201 managing the drug therapies of Medicaid recipients who are using
202 significant numbers of prescribed drugs each month. The
203 management process may include, but is not limited to,
204 comprehensive, physician-directed medical-record reviews, claims
205 analyses, and case evaluations to determine the medical
206 necessity and appropriateness of a patient’s treatment plan and
207 drug therapies. The agency may contract with a private
208 organization to provide drug-program-management services. The
209 Medicaid drug benefit management program shall include
210 initiatives to manage drug therapies for HIV/AIDS patients,
211 patients using 20 or more unique prescriptions in a 180-day
212 period, and the top 1,000 patients in annual spending. The
213 agency shall enroll any Medicaid recipient in the drug benefit
214 management program if he or she meets the specifications of this
215 subparagraph provision and is not enrolled in a Medicaid health
216 maintenance organization.
217 4. The agency may limit the size of its pharmacy network
218 based on need, competitive bidding, price negotiations,
219 credentialing, or similar criteria. The agency shall give
220 special consideration to rural areas in determining the size and
221 location of pharmacies included in the Medicaid pharmacy
222 network. A pharmacy credentialing process may include criteria
223 such as a pharmacy’s full-service status, location, size,
224 patient educational programs, patient consultation, disease
225 management services, and other characteristics. The agency may
226 impose a moratorium on Medicaid pharmacy enrollment if it is
227 determined that it has a sufficient number of Medicaid
228 participating providers. The agency must allow dispensing
229 practitioners to participate as a part of the Medicaid pharmacy
230 network regardless of the practitioner’s proximity to any other
231 entity that is dispensing prescription drugs under the Medicaid
232 program. A dispensing practitioner must meet all credentialing
233 requirements applicable to his or her practice, as determined by
234 the agency.
235 5. The agency shall develop and implement a program that
236 requires Medicaid practitioners who prescribe drugs to use a
237 counterfeit-proof prescription pad for Medicaid prescriptions.
238 The agency shall require the use of standardized counterfeit
239 proof prescription pads by Medicaid-participating prescribers or
240 prescribers who write prescriptions for Medicaid recipients. The
241 agency may implement the program in targeted geographic areas or
242 statewide.
243 5.6. The agency may enter into arrangements that require
244 manufacturers of generic drugs prescribed to Medicaid recipients
245 to provide rebates of at least 15.1 percent of the average
246 manufacturer price for the manufacturer’s generic products.
247 These arrangements shall require that if a generic-drug
248 manufacturer pays federal rebates for Medicaid-reimbursed drugs
249 at a level below 15.1 percent, the manufacturer must provide a
250 supplemental rebate to the state in an amount necessary to
251 achieve a 15.1-percent rebate level.
252 6.7. The agency may establish a preferred drug list as
253 described in this subsection, and, pursuant to the establishment
254 of such preferred drug list, negotiate supplemental rebates from
255 manufacturers that are in addition to those required by Title
256 XIX of the Social Security Act and at no less than 14 percent of
257 the average manufacturer price as defined in 42 U.S.C. s. 1936
258 on the last day of a quarter unless the federal or supplemental
259 rebate, or both, equals or exceeds 29 percent. There is no upper
260 limit on the supplemental rebates the agency may negotiate. The
261 agency may determine that specific products, brand-name or
262 generic, are competitive at lower rebate percentages. Agreement
263 to pay the minimum supplemental rebate percentage guarantees a
264 manufacturer that the Medicaid Pharmaceutical and Therapeutics
265 Committee will consider a product for inclusion on the preferred
266 drug list. However, a pharmaceutical manufacturer is not
267 guaranteed placement on the preferred drug list by simply paying
268 the minimum supplemental rebate. Agency decisions will be made
269 on the clinical efficacy of a drug and recommendations of the
270 Medicaid Pharmaceutical and Therapeutics Committee, as well as
271 the price of competing products minus federal and state rebates.
272 The agency may contract with an outside agency or contractor to
273 conduct negotiations for supplemental rebates. For the purposes
274 of this section, the term “supplemental rebates” means cash
275 rebates. Value-added programs as a substitution for supplemental
276 rebates are prohibited. The agency may seek any federal waivers
277 to implement this initiative.
278 7.8. The agency shall expand home delivery of pharmacy
279 products. The agency may amend the state plan and issue a
280 procurement, as necessary, in order to implement this program.
281 The procurements must include agreements with a pharmacy or
282 pharmacies located in the state to provide mail order delivery
283 services at no cost to the recipients who elect to receive home
284 delivery of pharmacy products. The procurement must focus on
285 serving recipients with chronic diseases for which pharmacy
286 expenditures represent a significant portion of Medicaid
287 pharmacy expenditures or which impact a significant portion of
288 the Medicaid population. The agency may seek and implement any
289 federal waivers necessary to implement this subparagraph.
290 8.9. The agency shall limit to one dose per month any drug
291 prescribed to treat erectile dysfunction.
292 9.a.10.a. The agency may implement a Medicaid behavioral
293 drug management system. The agency may contract with a vendor
294 that has experience in operating behavioral drug management
295 systems to implement this program. The agency may seek federal
296 waivers to implement this program.
297 b. The agency, in conjunction with the Department of
298 Children and Families, may implement the Medicaid behavioral
299 drug management system that is designed to improve the quality
300 of care and behavioral health prescribing practices based on
301 best practice guidelines, improve patient adherence to
302 medication plans, reduce clinical risk, and lower prescribed
303 drug costs and the rate of inappropriate spending on Medicaid
304 behavioral drugs. The program may include the following
305 elements:
306 (I) Provide for the development and adoption of best
307 practice guidelines for behavioral health-related drugs such as
308 antipsychotics, antidepressants, and medications for treating
309 bipolar disorders and other behavioral conditions; translate
310 them into practice; review behavioral health prescribers and
311 compare their prescribing patterns to a number of indicators
312 that are based on national standards; and determine deviations
313 from best practice guidelines.
314 (II) Implement processes for providing feedback to and
315 educating prescribers using best practice educational materials
316 and peer-to-peer consultation.
317 (III) Assess Medicaid beneficiaries who are outliers in
318 their use of behavioral health drugs with regard to the numbers
319 and types of drugs taken, drug dosages, combination drug
320 therapies, and other indicators of improper use of behavioral
321 health drugs.
322 (IV) Alert prescribers to patients who fail to refill
323 prescriptions in a timely fashion, are prescribed multiple same
324 class behavioral health drugs, and may have other potential
325 medication problems.
326 (V) Track spending trends for behavioral health drugs and
327 deviation from best practice guidelines.
328 (VI) Use educational and technological approaches to
329 promote best practices, educate consumers, and train prescribers
330 in the use of practice guidelines.
331 (VII) Disseminate electronic and published materials.
332 (VIII) Hold statewide and regional conferences.
333 (IX) Implement a disease management program with a model
334 quality-based medication component for severely mentally ill
335 individuals and emotionally disturbed children who are high
336 users of care.
337 10.11. The agency shall implement a Medicaid prescription
338 drug management system.
339 a. The agency may contract with a vendor that has
340 experience in operating prescription drug management systems in
341 order to implement this system. Any management system that is
342 implemented in accordance with this subparagraph must rely on
343 cooperation between physicians and pharmacists to determine
344 appropriate practice patterns and clinical guidelines to improve
345 the prescribing, dispensing, and use of drugs in the Medicaid
346 program. The agency may seek federal waivers to implement this
347 program.
348 b. The drug management system must be designed to improve
349 the quality of care and prescribing practices based on best
350 practice guidelines, improve patient adherence to medication
351 plans, reduce clinical risk, and lower prescribed drug costs and
352 the rate of inappropriate spending on Medicaid prescription
353 drugs. The program must:
354 (I) Provide for the adoption of best practice guidelines
355 for the prescribing and use of drugs in the Medicaid program,
356 including translating best practice guidelines into practice;
357 reviewing prescriber patterns and comparing them to indicators
358 that are based on national standards and practice patterns of
359 clinical peers in their community, statewide, and nationally;
360 and determine deviations from best practice guidelines.
361 (II) Implement processes for providing feedback to and
362 educating prescribers using best practice educational materials
363 and peer-to-peer consultation.
364 (III) Assess Medicaid recipients who are outliers in their
365 use of a single or multiple prescription drugs with regard to
366 the numbers and types of drugs taken, drug dosages, combination
367 drug therapies, and other indicators of improper use of
368 prescription drugs.
369 (IV) Alert prescribers to recipients who fail to refill
370 prescriptions in a timely fashion, are prescribed multiple drugs
371 that may be redundant or contraindicated, or may have other
372 potential medication problems.
373 11.12. The agency may contract for drug rebate
374 administration, including, but not limited to, calculating
375 rebate amounts, invoicing manufacturers, negotiating disputes
376 with manufacturers, and maintaining a database of rebate
377 collections.
378 12.13. The agency may specify the preferred daily dosing
379 form or strength for the purpose of promoting best practices
380 with regard to the prescribing of certain drugs as specified in
381 the General Appropriations Act and ensuring cost-effective
382 prescribing practices.
383 13.14. The agency may require prior authorization for
384 Medicaid-covered prescribed drugs. The agency may prior
385 authorize the use of a product:
386 a. For an indication not approved in labeling;
387 b. To comply with certain clinical guidelines; or
388 c. If the product has the potential for overuse, misuse, or
389 abuse.
390
391 The agency may require the prescribing professional to provide
392 information about the rationale and supporting medical evidence
393 for the use of a drug. The agency shall post prior
394 authorization, step-edit criteria and protocol, and updates to
395 the list of drugs that are subject to prior authorization on the
396 agency’s Internet website within 21 days after the prior
397 authorization and step-edit criteria and protocol and updates
398 are approved by the agency. For purposes of this subparagraph,
399 the term “step-edit” means an automatic electronic review of
400 certain medications subject to prior authorization.
401 14.15. The agency, in conjunction with the Pharmaceutical
402 and Therapeutics Committee, may require age-related prior
403 authorizations for certain prescribed drugs. The agency may
404 preauthorize the use of a drug for a recipient who may not meet
405 the age requirement or may exceed the length of therapy for use
406 of this product as recommended by the manufacturer and approved
407 by the Food and Drug Administration. Prior authorization may
408 require the prescribing professional to provide information
409 about the rationale and supporting medical evidence for the use
410 of a drug.
411 15.16. The agency shall implement a step-therapy prior
412 authorization approval process for medications excluded from the
413 preferred drug list. Medications listed on the preferred drug
414 list must be used within the previous 12 months before the
415 alternative medications that are not listed. The step-therapy
416 prior authorization may require the prescriber to use the
417 medications of a similar drug class or for a similar medical
418 indication unless contraindicated in the Food and Drug
419 Administration labeling. The trial period between the specified
420 steps may vary according to the medical indication. The step
421 therapy approval process shall be developed in accordance with
422 the committee as stated in s. 409.91195(7) and (8). A drug
423 product may be approved without meeting the step-therapy prior
424 authorization criteria if the prescribing physician provides the
425 agency with additional written medical or clinical documentation
426 that the product is medically necessary because:
427 a. There is not a drug on the preferred drug list to treat
428 the disease or medical condition which is an acceptable clinical
429 alternative;
430 b. The alternatives have been ineffective in the treatment
431 of the beneficiary’s disease; or
432 c. Based on historic evidence and known characteristics of
433 the patient and the drug, the drug is likely to be ineffective,
434 or the number of doses have been ineffective.
435
436 The agency shall work with the physician to determine the best
437 alternative for the patient. The agency may adopt rules waiving
438 the requirements for written clinical documentation for specific
439 drugs in limited clinical situations.
440 16.17. The agency shall implement a return and reuse
441 program for drugs dispensed by pharmacies to institutional
442 recipients, which includes payment of a $5 restocking fee for
443 the implementation and operation of the program. The return and
444 reuse program shall be implemented electronically and in a
445 manner that promotes efficiency. The program must permit a
446 pharmacy to exclude drugs from the program if it is not
447 practical or cost-effective for the drug to be included and must
448 provide for the return to inventory of drugs that cannot be
449 credited or returned in a cost-effective manner. The agency
450 shall determine if the program has reduced the amount of
451 Medicaid prescription drugs which are destroyed on an annual
452 basis and if there are additional ways to ensure more
453 prescription drugs are not destroyed which could safely be
454 reused.
455 Section 4. Section 456.0392, Florida Statutes, is amended
456 to read:
457 456.0392 Prescription labeling.—
458 (1) A prescription written by a practitioner who is
459 authorized under the laws of this state to prescribe write
460 prescriptions for drugs that are not listed as controlled
461 substances in chapter 893 but who is not eligible for a federal
462 Drug Enforcement Administration number shall include that
463 practitioner’s name and professional license number. The
464 pharmacist or dispensing practitioner must include the
465 practitioner’s name on the container of the drug that is
466 dispensed. A pharmacist shall be permitted, upon verification by
467 the prescriber, to document any information required by this
468 section.
469 (2) A prescription for a drug that is not listed as a
470 controlled substance in chapter 893 which is written by an
471 advanced practice registered nurse licensed under s. 464.012 is
472 presumed, subject to rebuttal, to be valid and within the
473 parameters of the prescriptive authority delegated by a
474 practitioner licensed under chapter 458, chapter 459, or chapter
475 466.
476 (3) A prescription for a drug that is not listed as a
477 controlled substance in chapter 893 which is written by a
478 physician assistant licensed under chapter 458 or chapter 459 is
479 presumed, subject to rebuttal, to be valid and within the
480 parameters of the prescriptive authority delegated by the
481 physician assistant’s supervising physician.
482 Section 5. Paragraph (d) of subsection (3) of section
483 458.3265, Florida Statutes, is amended to read:
484 458.3265 Pain-management clinics.—
485 (3) 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 (d) A physician authorized to prescribe controlled
490 substances who practices at a pain-management clinic is
491 responsible for maintaining the control and security of his or
492 her electronic prescribing software prescription blanks and any
493 other method used for prescribing controlled substance pain
494 medication. The physician shall comply with the requirements for
495 counterfeit-resistant prescription blanks in s. 893.065 and the
496 rules adopted pursuant to that section. The physician shall
497 notify, in writing, the department within 24 hours after
498 following any theft or loss of a prescription blank or breach of
499 his or her electronic prescribing software any other method for
500 prescribing pain medication.
501 Section 6. Paragraph (qq) of subsection (1) of section
502 458.331, Florida Statutes, is amended to read:
503 458.331 Grounds for disciplinary action; action by the
504 board and department.—
505 (1) The following acts constitute grounds for denial of a
506 license or disciplinary action, as specified in s. 456.072(2):
507 (qq) Failing to timely notify the department of the theft
508 of prescription blanks from a pain-management clinic or a breach
509 of a physician’s electronic prescribing software other methods
510 for prescribing within 24 hours as required by s. 458.3265(3).
511 Section 7. Paragraph (e) of subsection (4) of section
512 458.347, Florida Statutes, is amended to read:
513 458.347 Physician assistants.—
514 (4) PERFORMANCE OF PHYSICIAN ASSISTANTS.—
515 (e) A supervising physician may delegate to a fully
516 licensed physician assistant the authority to prescribe or
517 dispense any medication used in the supervising physician’s
518 practice unless such medication is listed on the formulary
519 created pursuant to paragraph (f). A fully licensed physician
520 assistant may only prescribe or dispense such medication under
521 the following circumstances:
522 1. A physician assistant must clearly identify to the
523 patient that he or she is a physician assistant and inform the
524 patient that the patient has the right to see the physician
525 before a prescription is prescribed or dispensed by the
526 physician assistant.
527 2. The supervising physician must notify the department of
528 his or her intent to delegate, on a department-approved form,
529 before delegating such authority and of any change in
530 prescriptive privileges of the physician assistant. Authority to
531 dispense may be delegated only by a supervising physician who is
532 registered as a dispensing practitioner in compliance with s.
533 465.0276.
534 3. The physician assistant must complete a minimum of 10
535 continuing medical education hours in the specialty practice in
536 which the physician assistant has prescriptive privileges with
537 each licensure renewal. Three of the 10 hours must consist of a
538 continuing education course on the safe and effective
539 prescribing of controlled substance medications which is offered
540 by a statewide professional association of physicians in this
541 state accredited to provide educational activities designated
542 for the American Medical Association Physician’s Recognition
543 Award Category 1 credit or designated by the American Academy of
544 Physician Assistants as a Category 1 credit.
545 4. The department may issue a prescriber number to the
546 physician assistant granting authority for the prescribing of
547 medicinal drugs authorized within this paragraph upon completion
548 of the requirements of this paragraph. The physician assistant
549 is not required to independently register pursuant to s.
550 465.0276.
551 5. The prescription may be in paper or electronic form but
552 must comply with ss. 456.0392(1) and 456.42(1) and chapter 499
553 and must contain, in addition to the supervising physician’s
554 name, address, and telephone number, the physician assistant’s
555 prescriber number. Unless it is a drug or drug sample dispensed
556 by the physician assistant, the prescription must be filled in a
557 pharmacy permitted under chapter 465 and must be dispensed in
558 that pharmacy by a pharmacist licensed under chapter 465. The
559 inclusion of the prescriber number creates a presumption that
560 the physician assistant is authorized to prescribe the medicinal
561 drug and the prescription is valid.
562 6. The physician assistant must note the prescription or
563 dispensing of medication in the appropriate medical record.
564 Section 8. Paragraph (d) of subsection (3) of section
565 459.0137, Florida Statutes, is amended to read:
566 459.0137 Pain-management clinics.—
567 (3) PHYSICIAN RESPONSIBILITIES.—These responsibilities
568 apply to any osteopathic physician who provides professional
569 services in a pain-management clinic that is required to be
570 registered in subsection (1).
571 (d) An osteopathic physician authorized to prescribe
572 controlled substances who practices at a pain-management clinic
573 is responsible for maintaining the control and security of his
574 or her electronic prescribing software prescription blanks and
575 any other method used for prescribing controlled substance pain
576 medication. The osteopathic physician shall comply with the
577 requirements for counterfeit-resistant prescription blanks in s.
578 893.065 and the rules adopted pursuant to that section. The
579 osteopathic physician shall notify, in writing, the department
580 within 24 hours after following any theft or loss of a
581 prescription blank or breach of his or her electronic
582 prescribing software of any other method for prescribing pain
583 medication.
584 Section 9. Paragraph (ss) of subsection (1) of section
585 459.015, Florida Statutes, is amended to read:
586 459.015 Grounds for disciplinary action; action by the
587 board and department.—
588 (1) The following acts constitute grounds for denial of a
589 license or disciplinary action, as specified in s. 456.072(2):
590 (ss) Failing to timely notify the department of the theft
591 of prescription blanks from a pain-management clinic or a breach
592 of an osteopathic physician’s electronic prescribing software of
593 other methods for prescribing within 24 hours as required by s.
594 459.0137(3).
595 Section 10. Paragraph (e) of subsection (4) of section
596 459.022, Florida Statutes, is amended to read:
597 459.022 Physician assistants.—
598 (4) PERFORMANCE OF PHYSICIAN ASSISTANTS.—
599 (e) A supervising physician may delegate to a fully
600 licensed physician assistant the authority to prescribe or
601 dispense any medication used in the supervising physician’s
602 practice unless such medication is listed on the formulary
603 created pursuant to s. 458.347. A fully licensed physician
604 assistant may only prescribe or dispense such medication under
605 the following circumstances:
606 1. A physician assistant must clearly identify to the
607 patient that she or he is a physician assistant and must inform
608 the patient that the patient has the right to see the physician
609 before a prescription is prescribed or dispensed by the
610 physician assistant.
611 2. The supervising physician must notify the department of
612 her or his intent to delegate, on a department-approved form,
613 before delegating such authority and of any change in
614 prescriptive privileges of the physician assistant. Authority to
615 dispense may be delegated only by a supervising physician who is
616 registered as a dispensing practitioner in compliance with s.
617 465.0276.
618 3. The physician assistant must complete a minimum of 10
619 continuing medical education hours in the specialty practice in
620 which the physician assistant has prescriptive privileges with
621 each licensure renewal.
622 4. The department may issue a prescriber number to the
623 physician assistant granting authority for the prescribing of
624 medicinal drugs authorized within this paragraph upon completion
625 of the requirements of this paragraph. The physician assistant
626 is not required to independently register pursuant to s.
627 465.0276.
628 5. The prescription may be in paper or electronic form but
629 must comply with ss. 456.0392(1) and 456.42(1) and chapter 499
630 and must contain, in addition to the supervising physician’s
631 name, address, and telephone number, the physician assistant’s
632 prescriber number. Unless it is a drug or drug sample dispensed
633 by the physician assistant, the prescription must be filled in a
634 pharmacy permitted under chapter 465, and must be dispensed in
635 that pharmacy by a pharmacist licensed under chapter 465. The
636 inclusion of the prescriber number creates a presumption that
637 the physician assistant is authorized to prescribe the medicinal
638 drug and the prescription is valid.
639 6. The physician assistant must note the prescription or
640 dispensing of medication in the appropriate medical record.
641 Section 11. Sections 456.43, 831.311, and 893.065, Florida
642 Statutes, are repealed.
643 Section 12. This act shall take effect January 1, 2020.