1 | A bill to be entitled |
2 | An act relating to controlled substances; creating s. |
3 | 408.0513, F.S.; requiring the Agency for Health Care |
4 | Administration to contract with a multistate electronic |
5 | prescribing network to provide certain agencies with |
6 | access to certain controlled substance information; |
7 | requiring the Agency for Health Care Administration to |
8 | adopt rules and seek grants and donations; amending ss. |
9 | 458.309 and 459.005, F.S.; revising requirements for the |
10 | registration of pain-management clinics; requiring the |
11 | Department of Health to refuse to register pain-management |
12 | clinics under certain circumstances; amending ss. 458.331 |
13 | and 459.015, F.S.; specifying additional grounds for |
14 | disciplinary action against practitioners licensed under |
15 | ch. 458 or ch. 459, F.S.; amending s. 465.018, F.S.; |
16 | requiring community pharmacy permit applicants to |
17 | demonstrate the ability to participate in and transmit |
18 | dispensing information through a multistate electronic |
19 | prescribing network; requiring community pharmacy |
20 | permittees to transmit dispensing information through such |
21 | a network for prescriptions of certain controlled |
22 | substances; amending s. 465.023, F.S.; specifying an |
23 | additional ground for disciplinary action against |
24 | community pharmacy permittees; amending s. 465.0276, F.S.; |
25 | prohibiting registered dispensing practitioners from |
26 | dispensing more than a specified amount of certain |
27 | controlled substances; providing penalties; providing |
28 | exceptions; reenacting ss. 458.303, 458.311(1)(d) and (5), |
29 | 458.313(6), 458.3135(2)(d), 458.3137(2)(e), |
30 | 458.3145(1)(g), and 458.345(1)(b) and (2), F.S., relating |
31 | to provisions not applicable to certain practitioners, |
32 | licensure of physicians by examination, licensure of |
33 | physicians by endorsement, temporary certificates for |
34 | visiting physicians practicing in approved cancer centers, |
35 | temporary certificates for visiting physicians in |
36 | conjunction with certain plastic surgery training programs |
37 | and educational symposiums, medical faculty certificates, |
38 | and registration of resident physicians, interns, and |
39 | fellows, respectively, to incorporate the amendment made |
40 | by this act to s. 458.331, F.S., in references thereto; |
41 | reenacting s. 459.021(8), F.S., relating to the |
42 | registration of resident osteopathic physicians, interns, |
43 | and fellows, to incorporate the amendment made by this act |
44 | to s. 459.015, F.S., in a reference thereto; providing an |
45 | effective date. |
46 |
|
47 | Be It Enacted by the Legislature of the State of Florida: |
48 |
|
49 | Section 1. Section 408.0513, Florida Statutes, is created |
50 | to read: |
51 | 408.0513 Access to prescription drug medication history.- |
52 | (1) By December 1, 2010, the agency shall contract with an |
53 | entity that operates a multistate electronic prescribing network |
54 | to provide the following agencies with access to the controlled |
55 | substance information available on such network for the |
56 | controlled substances listed in Schedules II and III of s. |
57 | 893.03: |
58 | (a) A criminal justice agency as defined in s. 119.011 |
59 | that enforces the laws of this state or the United States and |
60 | that initiates an active investigation involving a specific |
61 | violation of law. |
62 | (b) The Department of Health or the relevant health |
63 | regulatory board responsible for the licensure, regulation, or |
64 | discipline of practitioners, pharmacists, or other persons who |
65 | are authorized to prescribe, administer, or dispense controlled |
66 | substances and who are involved in a specific investigation |
67 | involving a designated person. |
68 | (2) The agency shall adopt rules under ss. 120.536(1) and |
69 | 120.54 to administer this section, including the method and |
70 | terms of access to the information provided under subsection |
71 | (1). |
72 | (3) The agency shall seek federal grants and donations |
73 | from private entities to implement this section. |
74 | Section 2. Subsection (4) of section 458.309, Florida |
75 | Statutes, is amended to read: |
76 | 458.309 Rulemaking authority.- |
77 | (4) All privately owned pain-management clinics, |
78 | facilities, or offices, hereinafter referred to as "clinics," |
79 | primarily engaged in the treatment of pain by prescribing or |
80 | dispensing controlled substances, which advertise in any medium |
81 | for any type of pain-management services, or employ a physician |
82 | who is primarily engaged in the treatment of pain by prescribing |
83 | or dispensing controlled substance medications, must register |
84 | with the department by January 4, 2010, unless that clinic is |
85 | licensed as a facility pursuant to chapter 395. The department |
86 | shall refuse to register any clinic not wholly owned by a |
87 | physician or group of physicians; any clinic owned by or having |
88 | any contractual or employment relationship with a physician |
89 | whose federal Drug Enforcement Administration registration |
90 | number has ever been suspended or revoked or against whom the |
91 | board has taken final administrative action relating to the |
92 | physician's impairment due to the misuse or abuse of alcohol or |
93 | drugs; or any clinic the ownership or any controlling interest |
94 | of which is held by any person who has been convicted of, or has |
95 | entered a plea of guilty or nolo contendere to, regardless of |
96 | adjudication, a felony under chapter 893. A physician may not |
97 | practice medicine in a pain-management clinic that is required |
98 | to register but has not registered with the department. Each |
99 | clinic location shall be registered separately regardless of |
100 | whether the clinic is operated under the same business name or |
101 | management as another clinic. If the clinic is licensed as a |
102 | health care clinic under chapter 400, the medical director is |
103 | responsible for registering the facility with the department. If |
104 | the clinic is not registered pursuant to chapter 395 or chapter |
105 | 400, the clinic shall, upon registration with the department, |
106 | designate a physician who is responsible for complying with all |
107 | requirements related to registration of the clinic. The |
108 | designated physician shall be licensed under this chapter or |
109 | chapter 459 and shall practice at the office location for which |
110 | the physician has assumed responsibility. The department shall |
111 | inspect the clinic annually to ensure that it complies with |
112 | rules of the Board of Medicine adopted pursuant to this |
113 | subsection and subsection (5) unless the office is accredited by |
114 | a nationally recognized accrediting agency approved by the Board |
115 | of Medicine. The actual costs for registration and inspection or |
116 | accreditation shall be paid by the physician seeking to register |
117 | the clinic. |
118 | Section 3. Paragraph (nn) of subsection (1) of section |
119 | 458.331, Florida Statutes, is redesignated as paragraph (pp), |
120 | and new paragraphs (nn) and (oo) are added to that subsection to |
121 | read: |
122 | 458.331 Grounds for disciplinary action; action by the |
123 | board and department.- |
124 | (1) The following acts constitute grounds for denial of a |
125 | license or disciplinary action, as specified in s. 456.072(2): |
126 | (nn) Practicing medicine in a clinic that is required to |
127 | register but has not registered with the department pursuant to |
128 | s. 458.309. |
129 | (oo) Promoting or advertising through any communication |
130 | media the use, sale, or dispensing of any controlled substance |
131 | appearing on any schedule in chapter 893. |
132 | Section 4. Subsection (3) of section 459.005, Florida |
133 | Statutes, is amended to read: |
134 | 459.005 Rulemaking authority.- |
135 | (3) All privately owned pain-management clinics, |
136 | facilities, or offices, hereinafter referred to as "clinics," |
137 | primarily engaged in the treatment of pain by prescribing or |
138 | dispensing controlled substances, which advertise in any medium |
139 | for any type of pain-management services, or employ a physician |
140 | who is licensed under this chapter and who is primarily engaged |
141 | in the treatment of pain by prescribing or dispensing controlled |
142 | substance medications, must register with the department by |
143 | January 4, 2010, unless that clinic is licensed as a facility |
144 | under chapter 395. The department shall refuse to register any |
145 | clinic not wholly owned by a physician or group of physicians; |
146 | any clinic owned by or having any contractual or employment |
147 | relationship with a physician whose federal Drug Enforcement |
148 | Administration registration number has ever been suspended or |
149 | revoked or against whom the board has taken final administrative |
150 | action relating to the physician's impairment due to the misuse |
151 | or abuse of alcohol or drugs; or any clinic the ownership or any |
152 | controlling interest of which is held by any person who has been |
153 | convicted of, or has entered a plea of guilty or nolo contendere |
154 | to, regardless of adjudication, a felony under chapter 893. A |
155 | physician may not practice osteopathic medicine in a pain- |
156 | management clinic that is required to register but has not |
157 | registered with the department. Each clinic location shall be |
158 | registered separately regardless of whether the clinic is |
159 | operated under the same business name or management as another |
160 | clinic. If the clinic is licensed as a health care clinic under |
161 | chapter 400, the medical director is responsible for registering |
162 | the facility with the department. If the clinic is not |
163 | registered under chapter 395 or chapter 400, the clinic shall, |
164 | upon registration with the department, designate a physician who |
165 | is responsible for complying with all requirements related to |
166 | registration of the clinic. The designated physician shall be |
167 | licensed under chapter 458 or this chapter and shall practice at |
168 | the office location for which the physician has assumed |
169 | responsibility. The department shall inspect the clinic annually |
170 | to ensure that it complies with rules of the Board of |
171 | Osteopathic Medicine adopted pursuant to this subsection and |
172 | subsection (4) unless the office is accredited by a nationally |
173 | recognized accrediting agency approved by the Board of |
174 | Osteopathic Medicine. The actual costs for registration and |
175 | inspection or accreditation shall be paid by the physician |
176 | seeking to register the clinic. |
177 | Section 5. Paragraph (pp) of subsection (1) of section |
178 | 459.015, Florida Statutes, is redesignated as paragraph (rr), |
179 | and new paragraphs (pp) and (qq) are added to that subsection to |
180 | read: |
181 | 459.015 Grounds for disciplinary action; action by the |
182 | board and department.- |
183 | (1) The following acts constitute grounds for denial of a |
184 | license or disciplinary action, as specified in s. 456.072(2): |
185 | (pp) Practicing osteopathic medicine in a clinic that is |
186 | required to register but has not registered with the department |
187 | pursuant to s. 459.005. |
188 | (qq) Promoting or advertising through any communication |
189 | media the use, sale, or dispensing of any controlled substance |
190 | appearing on any schedule in chapter 893. |
191 | Section 6. Section 465.018, Florida Statutes, is amended |
192 | to read: |
193 | 465.018 Community pharmacies; permits.-Any person desiring |
194 | a permit to operate a community pharmacy shall apply to the |
195 | department. If the board office certifies that the application |
196 | complies with the laws of the state and the rules of the board |
197 | governing pharmacies, the department shall issue the permit. A |
198 | No permit may not shall be issued unless a licensed pharmacist |
199 | is designated as the prescription department manager responsible |
200 | for maintaining all drug records, providing for the security of |
201 | the prescription department, and following such other rules as |
202 | relate to the practice of the profession of pharmacy. The |
203 | permittee and the newly designated prescription department |
204 | manager shall notify the department within 10 days of any change |
205 | in prescription department manager. Effective July 1, 2012, a |
206 | permit may not be issued unless the applicant demonstrates the |
207 | ability to participate in and transmit dispensing information |
208 | through a multistate electronic prescribing network. Effective |
209 | January 1, 2013, a permittee must transmit dispensing |
210 | information through a multistate electronic prescribing network |
211 | for each prescription of a controlled substance listed in |
212 | Schedule II or Schedule III of s. 893.03. |
213 | Section 7. Subsection (1) of section 465.023, Florida |
214 | Statutes, is amended to read: |
215 | 465.023 Pharmacy permittee; disciplinary action.- |
216 | (1) The department or the board may revoke or suspend the |
217 | permit of any pharmacy permittee, and may fine, place on |
218 | probation, or otherwise discipline any pharmacy permittee if the |
219 | permittee, or any affiliated person, partner, officer, director, |
220 | or agent of the permittee, including a person fingerprinted |
221 | under s. 465.022(3), has: |
222 | (a) Obtained a permit by misrepresentation or fraud or |
223 | through an error of the department or the board; |
224 | (b) Attempted to procure, or has procured, a permit for |
225 | any other person by making, or causing to be made, any false |
226 | representation; |
227 | (c) Violated any of the requirements of this chapter or |
228 | any of the rules of the Board of Pharmacy; of chapter 499, known |
229 | as the "Florida Drug and Cosmetic Act"; of 21 U.S.C. ss. 301- |
230 | 392, known as the "Federal Food, Drug, and Cosmetic Act"; of 21 |
231 | U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse |
232 | Prevention and Control Act; or of chapter 893; |
233 | (d) Been convicted or found guilty, regardless of |
234 | adjudication, of a felony or any other crime involving moral |
235 | turpitude in any of the courts of this state, of any other |
236 | state, or of the United States; |
237 | (e) Been convicted or disciplined by a regulatory agency |
238 | of the Federal Government or a regulatory agency of another |
239 | state for any offense that would constitute a violation of this |
240 | chapter; |
241 | (f) Been convicted of, or entered a plea of guilty or nolo |
242 | contendere to, regardless of adjudication, a crime in any |
243 | jurisdiction which relates to the practice of, or the ability to |
244 | practice, the profession of pharmacy; |
245 | (g) Been convicted of, or entered a plea of guilty or nolo |
246 | contendere to, regardless of adjudication, a crime in any |
247 | jurisdiction which relates to health care fraud; or |
248 | (h) Dispensed any medicinal drug based upon a |
249 | communication that purports to be a prescription as defined by |
250 | s. 465.003(14) or s. 893.02 when the pharmacist knows or has |
251 | reason to believe that the purported prescription is not based |
252 | upon a valid practitioner-patient relationship that includes a |
253 | documented patient evaluation, including history and a physical |
254 | examination adequate to establish the diagnosis for which any |
255 | drug is prescribed and any other requirement established by |
256 | board rule under chapter 458, chapter 459, chapter 461, chapter |
257 | 463, chapter 464, or chapter 466; or |
258 | (i) Failed to transmit dispensing information through a |
259 | multistate electronic prescribing network pursuant to s. 465.018 |
260 | for any prescription of a controlled substance listed in |
261 |
|
262 | Section 8. Subsection (1) of section 465.0276, Florida |
263 | Statutes, is amended to read: |
264 | 465.0276 Dispensing practitioner.- |
265 | (1)(a) A person may not dispense medicinal drugs unless |
266 | licensed as a pharmacist or otherwise authorized under this |
267 | chapter to do so, except that a practitioner authorized by law |
268 | to prescribe drugs may dispense such drugs to her or his |
269 | patients in the regular course of her or his practice in |
270 | compliance with this section. |
271 | (b) A practitioner registered under this section may not |
272 | dispense more than a 72-hour supply of a controlled substance |
273 | listed in Schedule II or Schedule III of s. 893.03. A |
274 | practitioner who violates this paragraph commits a felony of the |
275 | third degree, punishable as provided in s. 775.082, s. 775.083, |
276 | or s. 775.084. This paragraph does not apply to the dispensing |
277 | of complimentary packages of medicinal drugs to the |
278 | practitioner's own patients in the regular course of her or his |
279 | practice without the payment of a fee or remuneration of any |
280 | kind, whether direct or indirect, as provided in subsection (5). |
281 | This paragraph does not apply to a controlled substance |
282 | dispensed in the health care system of the Department of |
283 | Corrections. |
284 | Section 9. For the purpose of incorporating the amendment |
285 | made by this act to section 458.331, Florida Statutes, in |
286 | references thereto, section 458.303, Florida Statutes, is |
287 | reenacted to read: |
288 | 458.303 Provisions not applicable to other practitioners; |
289 | exceptions, etc.- |
290 | (1) The provisions of ss. 458.301, 458.303, 458.305, |
291 | 458.307, 458.309, 458.311, 458.313, 458.315, 458.317, 458.319, |
292 | 458.321, 458.327, 458.329, 458.331, 458.337, 458.339, 458.341, |
293 | 458.343, 458.345, and 458.347 shall have no application to: |
294 | (a) Other duly licensed health care practitioners acting |
295 | within their scope of practice authorized by statute. |
296 | (b) Any physician lawfully licensed in another state or |
297 | territory or foreign country, when meeting duly licensed |
298 | physicians of this state in consultation. |
299 | (c) Commissioned medical officers of the Armed Forces of |
300 | the United States and of the Public Health Service of the United |
301 | States while on active duty and while acting within the scope of |
302 | their military or public health responsibilities. |
303 | (d) Any person while actually serving without salary or |
304 | professional fees on the resident medical staff of a hospital in |
305 | this state, subject to the provisions of s. 458.321. |
306 | (e) Any person furnishing medical assistance in case of an |
307 | emergency. |
308 | (f) The domestic administration of recognized family |
309 | remedies. |
310 | (g) The practice of the religious tenets of any church in |
311 | this state. |
312 | (h) Any person or manufacturer who, without the use of |
313 | drugs or medicine, mechanically fits or sells lenses, artificial |
314 | eyes or limbs, or other apparatus or appliances or is engaged in |
315 | the mechanical examination of eyes for the purpose of |
316 | constructing or adjusting spectacles, eyeglasses, or lenses. |
317 | (2) Nothing in s. 458.301, s. 458.303, s. 458.305, s. |
318 | 458.307, s. 458.309, s. 458.311, s. 458.313, s. 458.319, s. |
319 | 458.321, s. 458.327, s. 458.329, s. 458.331, s. 458.337, s. |
320 | 458.339, s. 458.341, s. 458.343, s. 458.345, or s. 458.347 shall |
321 | be construed to prohibit any service rendered by a registered |
322 | nurse or a licensed practical nurse, if such service is rendered |
323 | under the direct supervision and control of a licensed physician |
324 | who provides specific direction for any service to be performed |
325 | and gives final approval to all services performed. Further, |
326 | nothing in this or any other chapter shall be construed to |
327 | prohibit any service rendered by a medical assistant in |
328 | accordance with the provisions of s. 458.3485. |
329 | Section 10. For the purpose of incorporating the amendment |
330 | made by this act to section 458.331, Florida Statutes, in |
331 | references thereto, paragraph (d) of subsection (1) and |
332 | subsection (5) of section 458.311, Florida Statutes, are |
333 | reenacted to read: |
334 | 458.311 Licensure by examination; requirements; fees.- |
335 | (1) Any person desiring to be licensed as a physician, who |
336 | does not hold a valid license in any state, shall apply to the |
337 | department on forms furnished by the department. The department |
338 | shall license each applicant who the board certifies: |
339 | (d) Has not committed any act or offense in this or any |
340 | other jurisdiction which would constitute the basis for |
341 | disciplining a physician pursuant to s. 458.331. |
342 | (5) The board may not certify to the department for |
343 | licensure any applicant who is under investigation in another |
344 | jurisdiction for an offense which would constitute a violation |
345 | of this chapter until such investigation is completed. Upon |
346 | completion of the investigation, the provisions of s. 458.331 |
347 | shall apply. Furthermore, the department may not issue an |
348 | unrestricted license to any individual who has committed any act |
349 | or offense in any jurisdiction which would constitute the basis |
350 | for disciplining a physician pursuant to s. 458.331. When the |
351 | board finds that an individual has committed an act or offense |
352 | in any jurisdiction which would constitute the basis for |
353 | disciplining a physician pursuant to s. 458.331, then the board |
354 | may enter an order imposing one or more of the terms set forth |
355 | in subsection (8). |
356 | Section 11. For the purpose of incorporating the amendment |
357 | made by this act to section 458.331, Florida Statutes, in |
358 | references thereto, subsection (6) of section 458.313, Florida |
359 | Statutes, is reenacted to read: |
360 | 458.313 Licensure by endorsement; requirements; fees.- |
361 | (6) The department shall not issue a license by |
362 | endorsement to any applicant who is under investigation in any |
363 | jurisdiction for an act or offense which would constitute a |
364 | violation of this chapter until such time as the investigation |
365 | is complete, at which time the provisions of s. 458.331 shall |
366 | apply. Furthermore, the department may not issue an unrestricted |
367 | license to any individual who has committed any act or offense |
368 | in any jurisdiction which would constitute the basis for |
369 | disciplining a physician pursuant to s. 458.331. When the board |
370 | finds that an individual has committed an act or offense in any |
371 | jurisdiction which would constitute the basis for disciplining a |
372 | physician pursuant to s. 458.331, the board may enter an order |
373 | imposing one or more of the terms set forth in subsection (7). |
374 | Section 12. For the purpose of incorporating the amendment |
375 | made by this act to section 458.331, Florida Statutes, in a |
376 | reference thereto, paragraph (d) of subsection (2) of section |
377 | 458.3135, Florida Statutes, is reenacted to read: |
378 | 458.3135 Temporary certificate for visiting physicians to |
379 | practice in approved cancer centers.- |
380 | (2) A temporary certificate for practice in an approved |
381 | cancer center may be issued without examination to an individual |
382 | who: |
383 | (d) Has not committed any act in this or any other |
384 | jurisdiction which would constitute the basis for disciplining a |
385 | physician under s. 456.072 or s. 458.331; |
386 | Section 13. For the purpose of incorporating the amendment |
387 | made by this act to section 458.331, Florida Statutes, in a |
388 | reference thereto, paragraph (e) of subsection (2) of section |
389 | 458.3137, Florida Statutes, is reenacted to read: |
390 | 458.3137 Temporary certificate for visiting physicians to |
391 | obtain medical privileges for instructional purposes in |
392 | conjunction with certain plastic surgery training programs and |
393 | plastic surgery educational symposiums.- |
394 | (2) A temporary certificate to practice medicine for |
395 | educational purposes to help teach plastic surgery residents of |
396 | a medical school within this state in conjunction with a |
397 | nationally sponsored educational symposium may be issued without |
398 | examination, upon verification by the board that the individual |
399 | meets all of the following requirements: |
400 | (e) Has not committed an act in this or any other |
401 | jurisdiction that would constitute a basis for disciplining a |
402 | physician under s. 456.072 or s. 458.331. |
403 | Section 14. For the purpose of incorporating the amendment |
404 | made by this act to section 458.331, Florida Statutes, in a |
405 | reference thereto, paragraph (g) of subsection (1) of section |
406 | 458.3145, Florida Statutes, is reenacted to read: |
407 | 458.3145 Medical faculty certificate.- |
408 | (1) A medical faculty certificate may be issued without |
409 | examination to an individual who: |
410 | (g) Has not committed any act in this or any other |
411 | jurisdiction which would constitute the basis for disciplining a |
412 | physician under s. 458.331; |
413 | Section 15. For the purpose of incorporating the amendment |
414 | made by this act to section 458.331, Florida Statutes, in |
415 | references thereto, paragraph (b) of subsection (1) and |
416 | subsection (2) of section 458.345, Florida Statutes, are |
417 | reenacted to read: |
418 | 458.345 Registration of resident physicians, interns, and |
419 | fellows; list of hospital employees; prescribing of medicinal |
420 | drugs; penalty.- |
421 | (1) Any person desiring to practice as a resident |
422 | physician, assistant resident physician, house physician, |
423 | intern, or fellow in fellowship training which leads to |
424 | subspecialty board certification in this state, or any person |
425 | desiring to practice as a resident physician, assistant resident |
426 | physician, house physician, intern, or fellow in fellowship |
427 | training in a teaching hospital in this state as defined in s. |
428 | 408.07(45) or s. 395.805(2), who does not hold a valid, active |
429 | license issued under this chapter shall apply to the department |
430 | to be registered and shall remit a fee not to exceed $300 as set |
431 | by the board. The department shall register any applicant the |
432 | board certifies has met the following requirements: |
433 | (b) Has not committed any act or offense within or without |
434 | the state which would constitute the basis for refusal to |
435 | certify an application for licensure pursuant to s. 458.331. |
436 | (2) The board shall not certify to the department for |
437 | registration any applicant who is under investigation in any |
438 | state or jurisdiction for an act which would constitute grounds |
439 | for disciplinary action under s. 458.331 until such time as the |
440 | investigation is completed, at which time the provisions of s. |
441 | 458.331 shall apply. |
442 | Section 16. For the purpose of incorporating the amendment |
443 | made by this act to section 459.015, Florida Statutes, in a |
444 | reference thereto, subsection (8) of section 459.021, Florida |
445 | Statutes, is reenacted to read: |
446 | 459.021 Registration of resident physicians, interns, and |
447 | fellows; list of hospital employees; penalty.- |
448 | (8) Notwithstanding any provision of this section or s. |
449 | 120.52 to the contrary, any person who is registered under this |
450 | section is subject to the provisions of s. 459.015. |
451 | Section 17. This act shall take effect July 1, 2010. |