CS/CS/HB 7095

1	A bill to be entitled
2	An act relating to controlled substances; amending s.
3	456.072, F.S.; making failure to comply with the
4	requirements of s. 456.44, F.S., grounds for disciplinary
5	action; providing mandatory administrative penalties for
6	certain violations related to prescribing; amending s.
7	456.42, F.S.; requiring prescriptions for controlled
8	substances to be written on a counterfeit-resistant pad
9	produced by an approved vendor or electronically
10	prescribed; providing conditions for being an approved
11	vendor; creating s. 456.44, F.S.; providing definitions;
12	requiring certain physicians to register with the
13	appropriate board to prescribe controlled substances for
14	the treatment of chronic, nonmalignant pain; providing an
15	effective date; requiring registered physicians to meet
16	certain standards of practice; requiring a physical
17	examination; requiring a written protocol; requiring an
18	assessment of risk for aberrant behavior; requiring a
19	treatment plan; requiring specified informed consent;
20	requiring consultation and referral in certain
21	circumstances; requiring medical records meeting certain
22	criteria; requiring a prescription log; providing an
23	exemption for physicians meeting certain criteria;
24	amending s. 458.3265, F.S., relating to regulation of
25	pain-management clinics and medical doctors; amending the
26	definition of a pain-management clinic; providing
27	definitions; providing an exemption from registration for
28	clinics owned and operated by physicians meeting certain
29	criteria; requiring physicians in pain-management clinics
30	to ensure compliance with certain requirements; imposing
31	facility and physical operations requirements; imposing
32	infection control requirements; imposing health and safety
33	requirements; imposing quality assurance requirements;
34	imposing data collection and reporting requirements;
35	amending rulemaking authority; conforming provisions to
36	changes made by the act; providing for future expiration
37	of provisions; amending s. 458.327, F.S.; providing that
38	dispensing certain controlled substances in violation of
39	specified provisions is a third-degree felony; providing
40	penalties; amending s. 458.331, F.S.; providing that
41	dispensing certain controlled substances in violation of
42	specified provisions is grounds for disciplinary action;
43	providing penalties; amending s. 459.0137, F.S., relating
44	to regulation of pain-management clinics and osteopathic
45	physicians; providing definitions; providing an exemption
46	from registration for clinics owned and operated by
47	physicians meeting certain criteria; requiring osteopathic
48	physicians in pain-management clinics to ensure compliance
49	with certain requirements; imposing facility and physical
50	operations requirements; imposing infection control
51	requirements; imposing health and safety requirements;
52	imposing quality assurance requirements; imposing data
53	collection and reporting requirements; amending rulemaking
54	authority; conforming provisions to changes made by the
55	act; providing for future expiration of provisions;
56	amending s. 459.013, F.S.; providing that dispensing
57	certain controlled substances in violation of specified
58	provisions is a third-degree felony; providing penalties;
59	amending s. 459.015, F.S.; providing that dispensing
60	certain controlled substances in violation of specified
61	provisions is grounds for disciplinary action; providing
62	penalties; amending s. 465.015, F.S.; requiring a
63	pharmacist to report to the sheriff within a specified
64	period any instance in which a person fraudulently
65	obtained or attempted to fraudulently obtain a controlled
66	substance; providing criminal penalties; providing
67	requirements for reports; amending s. 465.016, F.S.;
68	providing additional grounds for denial of or disciplinary
69	action against a pharmacist license; amending s. 465.018,
70	F.S.; providing grounds for permit denial or discipline;
71	requiring applicants to pay or make arrangements to pay
72	amounts owed to the Department of Health; requiring an
73	inspection; limiting the community pharmacies that may
74	dispense controlled substances; providing an effective
75	date; providing exemptions; requiring permittees to
76	maintain certain records; amending s. 465.022, F.S.;
77	requiring the Department of Health to adopt rules related
78	to procedures for dispensing controlled substances;
79	providing requirements for the issuance of a pharmacy
80	permit; requiring disclosure of financial interests;
81	requiring submission of policies and procedures and
82	providing for grounds for permit denial based on them;
83	requiring the Department of Health to deny a permit to
84	applicants under certain circumstances; requiring
85	permittees to provide notice of certain management
86	changes; requiring prescription department managers to
87	meet certain criteria; imposing duties on prescription
88	department managers; limiting the number of locations a
89	prescription department manager may manage; requiring the
90	board to adopt rules related to recordkeeping; providing
91	that permits are not transferable; increasing the fee for
92	a change of location; amending s. 465.0276, F.S.;
93	prohibiting registered dispensing practitioners from
94	dispensing certain controlled substances; providing an
95	exception for dispensing controlled substances in the
96	health care system of the Department of Corrections;
97	deleting a provision establishing a 72-hour supply limit
98	on dispensing certain controlled substances to certain
99	patients in registered pain-management clinics; amending
100	s. 499.0051, F.S.; providing criminal penalties for
101	violations of certain provisions of s. 499.0121, F.S.;
102	amending s. 499.012, F.S.; requiring wholesale distributor
103	permit applicants to submit documentation of credentialing
104	policies; amending s. 499.0121, F.S.; providing reporting
105	requirements for wholesale distributors of certain
106	controlled substances; requiring the Department of Health
107	to share the reported data with law enforcement agencies;
108	requiring the Department of Law Enforcement to make
109	investigations based on the reported data; providing
110	credentialing requirements for distribution of controlled
111	substances to certain entities by wholesale distributors;
112	requiring distributors to identify suspicious
113	transactions; requiring distributors to determine the
114	reasonableness of orders for controlled substances over
115	certain amounts; requiring distributors to report certain
116	transactions to the Department of Health; prohibiting
117	distribution to entities with certain criminal histories;
118	limiting monthly distribution amounts of certain
119	controlled substances to retail pharmacies; prohibiting
120	distribution to entities with certain criminal
121	backgrounds; amending s. 499.05, F.S.; authorizing
122	rulemaking concerning specified controlled substance
123	wholesale distributor reporting requirements and
124	credentialing requirements; amending s. 499.067, F.S.;
125	requiring the Department of Health to take disciplinary
126	action against wholesale distributors failing to comply
127	with specified credentialing or reporting requirements;
128	amending s. 810.02, F.S.; authorizing separate judgments
129	and sentences for burglary with the intent to commit theft
130	of a controlled substance under specified provisions and
131	for any applicable possession of controlled substance
132	offense under specified provisions in certain
133	circumstances; amending s. 812.014, F.S.; authorizing
134	separate judgments and sentences for theft of a controlled
135	substance under specified provisions and for any
136	applicable possession of controlled substance offense
137	under specified provisions in certain circumstances;
138	amending s. 893.055, F.S., relating to the prescription
139	drug monitoring program; deleting obsolete dates; deleting
140	references to the Office of Drug Control; requiring
141	reports to the prescription drug monitoring system to be
142	made in 7 days rather than 15 days; prohibiting the use of
143	certain funds to implement the program; requiring the
144	State Surgeon General to appoint a board of directors for
145	the direct-support organization; conforming provisions to
146	changes made by the act; amending s. 893.065, F.S.;
147	conforming provisions to changes made by the act; amending
148	s. 893.07, F.S.; providing that law enforcement officers
149	are not required to obtain a subpoena, court order, or
150	search warrant in order to obtain access to or copies of
151	specified controlled substance inventory records;
152	requiring reporting of the discovery of the theft or loss
153	of controlled substances to the sheriff within a specified
154	period; providing criminal penalties; repealing s. 2 of
155	chapter 2009-198, Laws of Florida, relating to the Program
156	Implementation and Oversight Task Force in the Executive
157	Office of the Governor concerning the electronic system
158	established for the prescription drug monitoring program;
159	providing a buyback program for undispensed controlled
160	substance inventory held by specified licensed physicians;
161	requiring reports of the program; providing for a
162	declaration of a public health emergency; requiring
163	certain actions relating to dispensing practitioners
164	identified as posing the greatest threat to public health;
165	providing an appropriation; providing for future repeal of
166	program provisions; providing an effective date.
167
168	Be It Enacted by the Legislature of the State of Florida:
169
170	Section 1.  Paragraph (mm) is added to subsection (1) of
171	section 456.072, Florida Statutes, subsection (7) is
172	redesignated as subsection (8), and a new subsection (7) is
173	added to that section, to read:
174	456.072  Grounds for discipline; penalties; enforcement.-
175	(1)  The following acts shall constitute grounds for which
176	the disciplinary actions specified in subsection (2) may be
177	taken:
178	(mm)  Failure to comply with controlled substance
179	prescribing requirements of s. 456.44.
180	(7)  Any licensee who has been found to overprescribe or
181	inappropriately prescribe controlled substances in violation of
182	s. 456.44, s. 458.331(1)(q) or (t), s. 459.015(t) or (x), s.
183	461.013(1)(o) or (s), or s. 466.028(1)(p) or (x) shall be
184	suspended for a period of not less than 6 months and pay a fine
185	of not less than $10,000 per count. Repeated violations shall
186	result in increased penalties.
187	Section 2.  Section 456.42, Florida Statutes, is amended to
188	read:
189	456.42  Written prescriptions for medicinal drugs.-
190	(1)  A written prescription for a medicinal drug issued by
191	a health care practitioner licensed by law to prescribe such
192	drug must be legibly printed or typed so as to be capable of
193	being understood by the pharmacist filling the prescription;
194	must contain the name of the prescribing practitioner, the name
195	and strength of the drug prescribed, the quantity of the drug
196	prescribed, and the directions for use of the drug; must be
197	dated; and must be signed by the prescribing practitioner on the
198	day when issued. A written prescription for a controlled
199	substance listed in chapter 893 must have the quantity of the
200	drug prescribed in both textual and numerical formats and must
201	be dated with the abbreviated month written out on the face of
202	the prescription. However, a prescription that is electronically
203	generated and transmitted must contain the name of the
204	prescribing practitioner, the name and strength of the drug
205	prescribed, the quantity of the drug prescribed in numerical
206	format, and the directions for use of the drug and must be dated
207	and signed by the prescribing practitioner only on the day
208	issued, which signature may be in an electronic format as
209	defined in s. 668.003(4).
210	(2)  A written prescription for a controlled substance
211	listed in chapter 893 must have the quantity of the drug
212	prescribed in both textual and numerical formats, must be dated
213	with the abbreviated month written out on the face of the
214	prescription, and must be either written on a standardized
215	counterfeit-proof prescription pad produced by a vendor approved
216	by the department or electronically prescribed as that term is
217	used in s. 408.0611. As a condition of being an approved vendor,
218	a prescription pad vendor must submit a monthly report to the
219	department which, at a minimum, documents the number of
220	prescription pads sold and identifies the purchasers. The
221	department may, by rule, require the reporting of additional
222	information.
223	Section 3.  Section 456.44, Florida Statutes, is created to
224	read:
225	456.44  Controlled substance prescribing.-
226	(1)  DEFINITIONS.-
227	(a)  "Addiction medicine specialist" means a board-
228	certified psychiatrist with a subspecialty certification in
229	addiction medicine or who is eligible for such subspecialty
230	certification in addiction medicine or an addiction medicine
231	physician certified or eligible for certification by the
232	American Society of Addiction Medicine.
233	(b)  "Adverse incident" means any incident set forth in s.
234	458.351(4)(a)-(e) or s. 459.026(4)(a)-(e).
235	(c)  "Board-certified pain management physician" means a
236	physician who possesses board certification by a specialty board
237	recognized by the American Board of Medical Specialties and
238	holds a subspecialty certification in pain medicine or who
239	possesses board certification in pain medicine by the American
240	Board of Pain Medicine.
241	(d)  "Mental health addiction facility" means a facility
242	licensed under chapter 394 or chapter 397.
243	(2)  REGISTRATION.-Effective January 1, 2012, a physician
244	licensed under chapter 458, chapter 459, chapter 461, or chapter
245	466 who prescribes any controlled substance, as defined in s.
246	893.03, for the treatment of chronic, nonmalignant pain, must:
247	(a)  Register with her or his professional licensing board
248	as a controlled substance prescribing practitioner.
249	(b)  Comply with the requirements of this section and
250	applicable board rules.
251	(3)  STANDARDS OF PRACTICE.-The standards of practice in
252	this section do not supersede the level of care, skill, and
253	treatment recognized in general law related to healthcare
254	licensure.
255	(a)  A complete medical history and a physical examination
256	must be conducted before beginning any treatment and must be
257	documented in the medical record. The exact components of the
258	physical examination shall be left to the judgment of the
259	clinician who is expected to perform a physical examination
260	proportionate to the diagnosis that justifies a treatment. The
261	medical record must, at a minimum, document the nature and
262	intensity of the pain, current and past treatments for pain,
263	underlying or coexisting diseases or conditions, the effect of
264	the pain on physical and psychological function, a review of
265	previous medical records, previous diagnostic studies, and
266	history of alcohol and substance abuse. The medical record shall
267	also document the presence of one or more recognized medical
268	indications for the use of a controlled substance. Each
269	registrant must develop a written plan for assessing each
270	patient's risk of aberrant drug-related behavior, which may
271	include patient drug testing. Registrants must assess each
272	patient's risk for aberrant drug-related behavior and monitor
273	that risk on an ongoing basis in accordance with the plan.
274	(b)  Each registrant must develop a written individualized
275	treatment plan for each patient. The treatment plan shall state
276	objectives that will be used to determine treatment success,
277	such as pain relief and improved physical and psychosocial
278	function, and shall indicate if any further diagnostic
279	evaluations or other treatments are planned. After treatment
280	begins, the physician shall adjust drug therapy to the
281	individual medical needs of each patient. Other treatment
282	modalities, including a rehabilitation program, shall be
283	considered depending on the etiology of the pain and the extent
284	to which the pain is associated with physical and psychosocial
285	impairment. The interdisciplinary nature of the treatment plan
286	shall be documented.
287	(c)  The physician shall discuss the risks and benefits of
288	the use of controlled substances, including the risks of abuse
289	and addiction, as well as physical dependence and its
290	consequences, with the patient, persons designated by the
291	patient, or the patient's surrogate or guardian if the patient
292	is incompetent. The physician shall use a written controlled
293	substance agreement between the physician and the patient
294	outlining the patient's responsibilities, including, but not
295	limited to:
296	1.  Number and frequency of controlled substance
297	prescriptions and refills.
298	2.  Patient compliance and reasons for which drug therapy
299	may be discontinued, such as a violation of the agreement.
300	3.  An agreement that controlled substances for the
301	treatment of chronic nonmalignant pain shall be prescribed by a
302	single treating physician unless otherwise authorized by the
303	treating physician and documented in the medical record.
304	(d)  The patient shall be seen by the physician at regular
305	intervals, not to exceed 3 months, to assess the efficacy of
306	treatment, ensure that controlled substance therapy remains
307	indicated, evaluate the patient's progress toward treatment
308	objectives, consider adverse drug effects, and review the
309	etiology of the pain. Continuation or modification of therapy
310	shall depend on the physician's evaluation of the patient's
311	progress. If treatment goals are not being achieved, despite
312	medication adjustments, the physician shall reevaluate the
313	appropriateness of continued treatment. The physician shall
314	monitor patient compliance in medication usage, related
315	treatment plans, controlled substance agreements, and
316	indications of substance abuse or diversion at a minimum of 3-
317	month intervals.
318	(e)  The physician shall refer the patient as necessary for
319	additional evaluation and treatment in order to achieve
320	treatment objectives. Special attention shall be given to those
321	patients who are at risk for misusing their medications and
322	those whose living arrangements pose a risk for medication
323	misuse or diversion. The management of pain in patients with a
324	history of substance abuse or with a comorbid psychiatric
325	disorder requires extra care, monitoring, and documentation and
326	requires consultation with or referral to an addictionologist or
327	psychiatrist.
328	(f)  A physician registered under this section must
329	maintain accurate, current, and complete records that are
330	accessible and readily available for review and comply with the
331	requirements of this section, the applicable practice act, and
332	applicable board rules. The medical records must include, but
333	are not limited to:
334	1.  The complete medical history and a physical
335	examination, including history of drug abuse or dependence.
336	2.  Diagnostic, therapeutic, and laboratory results.
337	3.  Evaluations and consultations.
338	4.  Treatment objectives.
339	5.  Discussion of risks and benefits.
340	6.  Treatments.
341	7.  Medications, including date, type, dosage, and quantity
342	prescribed.
343	8.  Instructions and agreements.
344	9.  Periodic reviews.
345	10.  Results of any drug testing.
346	11.  A photocopy of the patient's government-issued photo
347	identification.
348	12.  If a written prescription for a controlled substance
349	is given to the patient, a duplicate of the prescription.
350	13.  The physician's full name presented in a legible
351	manner.
352	(g)  Registrants must maintain a current and accurate log
353	of all prescriptions for controlled substances. The log must not
354	contain patient identifiable information, but must distinguish
355	unduplicated patients. Registrants must make the log available
356	to the department and law enforcement agencies upon request.
357	(h)  Patients with signs or symptoms of substance abuse
358	shall be immediately referred to a board-certified pain
359	management physician, an addiction medicine specialist, or a
360	mental health addiction facility as it pertains to drug abuse or
361	addiction unless the physician is board-certified or board-
362	eligible in pain management. Throughout the period of time
363	before receiving the consultant's report, a prescribing
364	physician shall clearly and completely document medical
365	justification for continued treatment with controlled substances
366	and those steps taken to ensure medically appropriate use of
367	controlled substances by the patient. Upon receipt of the
368	consultant's written report, the prescribing physician shall
369	incorporate the consultant's recommendations for continuing,
370	modifying, or discontinuing controlled substance therapy. The
371	resulting changes in treatment shall be specifically documented
372	in the patient's medical record. Evidence or behavioral
373	indications of diversion shall be followed by discontinuation of
374	controlled substance therapy and the patient shall be discharged
375	and all results of testing and actions taken by the physician
376	shall be documented in the patient's medical record.
377
378	This subsection does not apply to a board-certified physician
379	who has completed a fellowship in pain medicine approved by the
380	American Accreditation Council for Graduate Medical Education or
381	who is board-certified in pain medicine by a board approved by
382	the American Board of Medical Specialties and performs
383	interventional pain procedures of the type routinely billed
384	using surgical codes.
385	Section 4.  Section 458.3265, Florida Statutes, is amended
386	to read:
387	458.3265  Pain-management clinics.-
388	(1)  REGISTRATION.-
389	(a)1.  As used in this section, the term:
390	a.  "Chronic nonmalignant pain" means pain unrelated to
391	cancer or rheumatoid arthritis which persists beyond the usual
392	course of disease or the injury that is the cause of the pain or
393	more than 90 days after surgery.
394	b.  "Pain-management clinic" or "clinic" means a publicly
395	or privately owned facility where in any month a majority of
396	patients are prescribed opioids, benzodiazepines, barbiturates,
397	or carisoprodol for the treatment of chronic nonmalignant pain.
398	All privately owned pain-management clinics, facilities, or
399	offices, hereinafter referred to as "clinics," which advertise
400	in any medium for any type of pain-management services, or
401	employ a physician who is primarily engaged in the treatment of
402	pain by prescribing or dispensing controlled substance
403	medications,
404	2.  Each pain-management clinic must register with the
405	department unless:
406	a.1.  That clinic is licensed as a facility pursuant to
407	chapter 395;
408	b.2.  The majority of the physicians who provide services
409	in the clinic primarily provide surgical services;
410	c.3.  The clinic is owned by a publicly held corporation
411	whose shares are traded on a national exchange or on the over-
412	the-counter market and whose total assets at the end of the
413	corporation's most recent fiscal quarter exceeded $50 million;
414	d.4.  The clinic is affiliated with an accredited medical
415	school at which training is provided for medical students,
416	residents, or fellows;
417	e.5.  The clinic does not prescribe or dispense controlled
418	substances for the treatment of pain; or
419	f.6.  The clinic is owned by a corporate entity exempt from
420	federal taxation under 26 U.S.C. s. 501(c)(3); or
421	g.  The clinic is wholly owned and operated by a board-
422	certified anesthesiologist, physiatrist, neurologist, or another
423	medical specialist who has completed a fellowship in pain
424	medicine approved by the Accreditation Council for Graduate
425	Medical Education or who is board certified in pain medicine by
426	a board approved by the American Board of Medical Specialties,
427	and that medical specialist performs interventional pain
428	procedures of the type routinely billed using surgical codes, or
429	the clinic is wholly owned and operated by a group of such
430	specialists.
431	(b)  Each clinic location shall be registered separately
432	regardless of whether the clinic is operated under the same
433	business name or management as another clinic.
434	(c)  As a part of registration, a clinic must designate a
435	physician who is responsible for complying with all requirements
436	related to registration and operation of the clinic in
437	compliance with this section. Within 10 days after termination
438	of a designated physician, the clinic must notify the department
439	of the identity of another designated physician for that clinic.
440	The designated physician shall have a full, active, and
441	unencumbered license under this chapter or chapter 459 and shall
442	practice at the clinic location for which the physician has
443	assumed responsibility. Failing to have a licensed designated
444	physician practicing at the location of the registered clinic
445	may be the basis for a summary suspension of the clinic
446	registration certificate as described in s. 456.073(8) for a
447	license or s. 120.60(6).
448	(d)  The department shall deny registration to any clinic
449	that is not fully owned by a physician licensed under this
450	chapter or chapter 459 or a group of physicians, each of whom is
451	licensed under this chapter or chapter 459; or that is not a
452	health care clinic licensed under part X of chapter 400.
453	(e)  The department shall deny registration to any pain-
454	management clinic owned by or with any contractual or employment
455	relationship with a physician:
456	1.  Whose Drug Enforcement Administration number has ever
457	been revoked.
458	2.  Whose application for a license to prescribe, dispense,
459	or administer a controlled substance has been denied by any
460	jurisdiction.
461	3.  Who has been convicted of or pleaded guilty or nolo
462	contendere to, regardless of adjudication, an offense that
463	constitutes a felony for receipt of illicit and diverted drugs,
464	including a controlled substance listed in Schedule I, Schedule
465	II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
466	this state, any other state, or the United States.
467	(f)  If the department finds that a pain-management clinic
468	does not meet the requirement of paragraph (d) or is owned,
469	directly or indirectly, by a person meeting any criteria listed
470	in paragraph (e), the department shall revoke the certificate of
471	registration previously issued by the department. As determined
472	by rule, the department may grant an exemption to denying a
473	registration or revoking a previously issued registration if
474	more than 10 years have elapsed since adjudication. As used in
475	this subsection, the term "convicted" includes an adjudication
476	of guilt following a plea of guilty or nolo contendere or the
477	forfeiture of a bond when charged with a crime.
478	(g)  The department may revoke the clinic's certificate of
479	registration and prohibit all physicians associated with that
480	pain-management clinic from practicing at that clinic location
481	based upon an annual inspection and evaluation of the factors
482	described in subsection (3).
483	(h)  If the registration of a pain-management clinic is
484	revoked or suspended, the designated physician of the pain-
485	management clinic, the owner or lessor of the pain-management
486	clinic property, the manager, and the proprietor shall cease to
487	operate the facility as a pain-management clinic as of the
488	effective date of the suspension or revocation.
489	(i)  If a pain-management clinic registration is revoked or
490	suspended, the designated physician of the pain-management
491	clinic, the owner or lessor of the clinic property, the manager,
492	or the proprietor is responsible for removing all signs and
493	symbols identifying the premises as a pain-management clinic.
494	(j)  Upon the effective date of the suspension or
495	revocation, the designated physician of the pain-management
496	clinic shall advise the department of the disposition of the
497	medicinal drugs located on the premises. The disposition is
498	subject to the supervision and approval of the department.
499	Medicinal drugs that are purchased or held by a pain-management
500	clinic that is not registered may be deemed adulterated pursuant
501	to s. 499.006.
502	(k)  If the clinic's registration is revoked, any person
503	named in the registration documents of the pain-management
504	clinic, including persons owning or operating the pain-
505	management clinic, may not, as an individual or as a part of a
506	group, apply to operate a pain-management clinic for 5 years
507	after the date the registration is revoked.
508	(l)  The period of suspension for the registration of a
509	pain-management clinic shall be prescribed by the department,
510	but may not exceed 1 year.
511	(m)  A change of ownership of a registered pain-management
512	clinic requires submission of a new registration application.
513	(2)  PHYSICIAN RESPONSIBILITIES.-These responsibilities
514	apply to any physician who provides professional services in a
515	pain-management clinic that is required to be registered in
516	subsection (1).
517	(a)  A physician may not practice medicine in a pain-
518	management clinic, as described in subsection (4), if:
519	1.  The pain-management clinic is not registered with the
520	department as required by this section; or
521	2.  Effective July 1, 2012, the physician has not
522	successfully completed a pain-medicine fellowship that is
523	accredited by the Accreditation Council for Graduate Medical
524	Education or a pain-medicine residency that is accredited by the
525	Accreditation Council for Graduate Medical Education or, prior
526	to July 1, 2012, does not comply with rules adopted by the
527	board.
528
529	Any physician who qualifies to practice medicine in a pain-
530	management clinic pursuant to rules adopted by the Board of
531	Medicine as of July 1, 2012, may continue to practice medicine
532	in a pain-management clinic as long as the physician continues
533	to meet the qualifications set forth in the board rules. A
534	physician who violates this paragraph is subject to disciplinary
535	action by his or her appropriate medical regulatory board.
536	(b)  A person may not dispense any medication, including a
537	controlled substance, on the premises of a registered pain-
538	management clinic unless he or she is a physician licensed under
539	this chapter or chapter 459.
540	(c)  A physician must perform a physical examination of a
541	patient on the same day that he or she dispenses or prescribes a
542	controlled substance to a patient at a pain-management clinic.
543	If the physician prescribes or dispenses more than a 72-hour
544	dose of controlled substances for the treatment of chronic
545	nonmalignant pain, the physician must document in the patient's
546	record the reason for prescribing or dispensing that quantity.
547	(d)  A physician authorized to prescribe controlled
548	substances who practices at a pain-management clinic is
549	responsible for maintaining the control and security of his or
550	her prescription blanks and any other method used for
551	prescribing controlled substance pain medication. The physician
552	shall comply with the requirements for counterfeit-resistant
553	prescription blanks in s. 893.065 and the rules adopted pursuant
554	to that section. The physician shall notify, in writing, the
555	department within 24 hours following any theft or loss of a
556	prescription blank or breach of any other method for prescribing
557	pain medication.
558	(e)  The designated physician of a pain-management clinic
559	shall notify the applicable board in writing of the date of
560	termination of employment within 10 days after terminating his
561	or her employment with a pain-management clinic that is required
562	to be registered under subsection (1). Each physician practicing
563	in a pain-management clinic shall advise the Board of Medicine,
564	in writing, within 10 calendar days after beginning or ending
565	his or her practice at a pain-management clinic.
566	(f)  Each physician practicing in a pain management clinic
567	is responsible for ensuring compliance with the following
568	facility and physical operations requirements:
569	1.  A pain management clinic shall be located and operated
570	at a publicly accessible fixed location and must:
571	a.  Display a sign that can be viewed by the public that
572	contains the clinic name, hours of operations, and a street
573	address.
574	b.  Have a publicly listed telephone number and a dedicated
575	phone number to send and receive faxes with a fax machine that
576	shall be operational 24 hours per day.
577	c.  Have emergency lighting and communications.
578	d.  Have a reception and waiting area.
579	e.  Provide a restroom.
580	f.  Have an administrative area, including room for storage
581	of medical records, supplies, and equipment.
582	g.  Have private patient examination rooms.
583	h.  Have treatment rooms, if treatment is being provided to
584	the patients.
585	i.  Display a printed sign located in a conspicuous place
586	in the waiting room viewable by the public with the name and
587	contact information of the clinic's designated physician and the
588	names of all physicians practicing in the clinic.
589	j.  If the clinic stores and dispenses prescription drugs,
590	comply with ss. 499.0121 and 893.07.
591	2.  This section does not excuse a physician from providing
592	any treatment or performing any medical duty without the proper
593	equipment and materials as required by the standard of care.
594	This section does not supersede the level of care, skill, and
595	treatment recognized in general law related to healthcare
596	licensure.
597	(g)  Each physician practicing in a pain management clinic
598	is responsible for ensuring compliance with the following
599	infection control requirements.
600	1.  The clinic shall maintain equipment and supplies to
601	support infection prevention and control activities.
602	2.  The clinic shall identify infection risks based on the
603	following:
604	a.  Geographic location, community, and population served.
605	b.  The care, treatment, and services it provides.
606	c.  An analysis of its infection surveillance and control
607	data.
608	3.  The clinic shall maintain written infection prevention
609	policies and procedures that address the following:
610	a.  Prioritized risks.
611	b.  Limiting unprotected exposure to pathogens.
612	c.  Limiting the transmission of infections associated with
613	procedures performed in the clinic.
614	d.  Limiting the transmission of infections associated with
615	the clinic's use of medical equipment, devices, and supplies.
616	(h)  Each physician practicing in a pain management clinic
617	is responsible for ensuring compliance with the following health
618	and safety requirements:
619	1.  The clinic, including its grounds, buildings,
620	furniture, appliances, and equipment shall be structurally
621	sound, in good repair, clean, and free from health and safety
622	hazards.
623	2.  The clinic shall have evacuation procedures in the
624	event of an emergency, which shall include provisions for the
625	evacuation of disabled patients and employees.
626	3.  The clinic shall have a written facility-specific
627	disaster plan setting forth actions that will be taken in the
628	event of clinic closure due to unforeseen disasters and shall
629	include provisions for the protection of medical records and any
630	controlled substances.
631	4.  Each clinic shall have at least one employee on the
632	premises during patient care hours who is certified in Basic
633	Life Support and is trained in reacting to accidents and medical
634	emergencies until emergency medical personnel arrive.
635	(i)  The designated physician is responsible for ensuring
636	compliance with the following quality assurance requirements.
637	Each pain management clinic shall have an ongoing quality
638	assurance program that objectively and systematically monitors
639	and evaluates the quality and appropriateness of patient care,
640	evaluates methods to improve patient care, identifies and
641	corrects deficiencies within the facility, alerts the designated
642	physician to identify and resolve recurring problems, and
643	provides for opportunities to improve the facility's performance
644	and to enhance and improve the quality of care provided to the
645	public. The designated physician shall establish a quality
646	assurance program that includes the following components:
647	1.  The identification, investigation, and analysis of the
648	frequency and causes of adverse incidents to patients.
649	2.  The identification of trends or patterns of incidents.
650	3.  The development of measures to correct, reduce,
651	minimize, or eliminate the risk of adverse incidents to
652	patients.
653	4.  The documentation of these functions and periodic
654	review no less than quarterly of such information by the
655	designated physician.
656	(j)  The designated physician is responsible for ensuring
657	compliance with the following data collection and reporting
658	requirements:
659	1.  The designated physician for each pain-management
660	clinic shall report all adverse incidents to the department as
661	set forth in s. 458.351.
662	2.  The designated physician shall also report to the Board
663	of Medicine, in writing, on a quarterly basis the following
664	data:
665	a.  Number of new and repeat patients seen and treated at
666	the clinic who are prescribed controlled substance medications
667	for the treatment of chronic, nonmalignant pain.
668	b.  The number of patients discharged due to drug abuse.
669	c.  The number of patients discharged due to drug
670	diversion.
671	d.  The number of patients treated at the pain clinic whose
672	domicile is located somewhere other than in this state. A
673	patient's domicile is the patient's fixed or permanent home to
674	which he or she intends to return even though he or she may
675	temporarily reside elsewhere.
676	(3)  INSPECTION.-
677	(a)  The department shall inspect the pain-management
678	clinic annually, including a review of the patient records, to
679	ensure that it complies with this section and the rules of the
680	Board of Medicine adopted pursuant to subsection (4) unless the
681	clinic is accredited by a nationally recognized accrediting
682	agency approved by the Board of Medicine.
683	(b)  During an onsite inspection, the department shall make
684	a reasonable attempt to discuss each violation with the owner or
685	designated physician of the pain-management clinic before
686	issuing a formal written notification.
687	(c)  Any action taken to correct a violation shall be
688	documented in writing by the owner or designated physician of
689	the pain-management clinic and verified by followup visits by
690	departmental personnel.
691	(4)  RULEMAKING.-
692	(a)  The department shall adopt rules necessary to
693	administer the registration and inspection of pain-management
694	clinics which establish the specific requirements, procedures,
695	forms, and fees.
696	(b)  The department shall adopt a rule defining what
697	constitutes practice by a designated physician at the clinic
698	location for which the physician has assumed responsibility, as
699	set forth in subsection (1). When adopting the rule, the
700	department shall consider the number of clinic employees, the
701	location of the pain-management clinic, the clinic's hours of
702	operation, and the amount of controlled substances being
703	prescribed, dispensed, or administered at the pain-management
704	clinic.
705	(c)  The Board of Medicine shall adopt a rule establishing
706	the maximum number of prescriptions for Schedule II or Schedule
707	III controlled substances or the controlled substance Alprazolam
708	which may be written at any one registered pain-management
709	clinic during any 24-hour period.
710	(b)(d)  The Board of Medicine shall adopt rules setting
711	forth standards of practice for physicians practicing in
712	privately owned pain-management clinics that primarily engage in
713	the treatment of pain by prescribing or dispensing controlled
714	substance medications. Such rules shall address, but need not be
715	limited to:
716	1.  Facility operations;
717	2.  Physical operations;
718	3.  Infection control requirements;
719	4.  Health and safety requirements;
720	5.  Quality assurance requirements;
721	6.  Patient records;
722	7.  training requirements for all facility health care
723	practitioners who are not regulated by another board.;
724	8.  Inspections; and
725	9.  Data collection and reporting requirements.
726
727	A physician is primarily engaged in the treatment of pain by
728	prescribing or dispensing controlled substance medications when
729	the majority of the patients seen are prescribed or dispensed
730	controlled substance medications for the treatment of chronic
731	nonmalignant pain. Chronic nonmalignant pain is pain unrelated
732	to cancer which persists beyond the usual course of the disease
733	or the injury that is the cause of the pain or more than 90 days
734	after surgery.
735	(5)  PENALTIES; ENFORCEMENT.-
736	(a)  The department may impose an administrative fine on
737	the clinic of up to $5,000 per violation for violating the
738	requirements of this section; chapter 499, the Florida Drug and
739	Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
740	Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
741	Abuse Prevention and Control Act; chapter 893, the Florida
742	Comprehensive Drug Abuse Prevention and Control Act; or the
743	rules of the department. In determining whether a penalty is to
744	be imposed, and in fixing the amount of the fine, the department
745	shall consider the following factors:
746	1.  The gravity of the violation, including the probability
747	that death or serious physical or emotional harm to a patient
748	has resulted, or could have resulted, from the pain-management
749	clinic's actions or the actions of the physician, the severity
750	of the action or potential harm, and the extent to which the
751	provisions of the applicable laws or rules were violated.
752	2.  What actions, if any, the owner or designated physician
753	took to correct the violations.
754	3.  Whether there were any previous violations at the pain-
755	management clinic.
756	4.  The financial benefits that the pain-management clinic
757	derived from committing or continuing to commit the violation.
758	(b)  Each day a violation continues after the date fixed
759	for termination of the violation as ordered by the department
760	constitutes an additional, separate, and distinct violation.
761	(c)  The department may impose a fine and, in the case of
762	an owner-operated pain-management clinic, revoke or deny a pain-
763	management clinic's registration, if the clinic's designated
764	physician knowingly and intentionally misrepresents actions
765	taken to correct a violation.
766	(d)  An owner or designated physician of a pain-management
767	clinic who concurrently operates an unregistered pain-management
768	clinic is subject to an administrative fine of $5,000 per day.
769	(e)  If the owner of a pain-management clinic that requires
770	registration fails to apply to register the clinic upon a change
771	of ownership and operates the clinic under the new ownership,
772	the owner is subject to a fine of $5,000.
773	(6)  EXPIRATION.-This section expires January 1, 2016.
774	Section 5.  Paragraph (f) is added to subsection (1) of
775	section 458.327, Florida Statutes, to read:
776	458.327  Penalty for violations.-
777	(1)  Each of the following acts constitutes a felony of the
778	third degree, punishable as provided in s. 775.082, s. 775.083,
779	or s. 775.084:
780	(f)  Dispensing a controlled substance listed in Schedule
781	II or Schedule III in violation of s. 465.0276.
782	Section 6.  Paragraph (rr) is added to subsection (1) of
783	section 458.331, Florida Statutes, to read:
784	458.331  Grounds for disciplinary action; action by the
785	board and department.-
786	(1)  The following acts constitute grounds for denial of a
787	license or disciplinary action, as specified in s. 456.072(2):
788	(rr)  Dispensing a controlled substance listed in Schedule
789	II or Schedule III in violation of s. 465.0276.
790	Section 7.  Section 459.0137, Florida Statutes, is amended
791	to read:
792	459.0137  Pain-management clinics.-
793	(1)  REGISTRATION.-
794	(a)1.  As used in this section, the term:
795	a.  "Chronic nonmalignant pain" means pain unrelated to
796	cancer or rheumatoid arthritis which persists beyond the usual
797	course of disease or the injury that is the cause of the pain or
798	more than 90 days after surgery.
799	b.  "Pain-management clinic" or "clinic" means a publicly
800	or privately owned facility where in any month a majority of
801	patients are prescribed opioids, benzodiazepines, barbiturates,
802	or carisoprodol for the treatment of chronic nonmalignant pain.
803	All privately owned pain-management clinics, facilities, or
804	offices, hereinafter referred to as "clinics," which advertise
805	in any medium for any type of pain-management services, or
806	employ an osteopathic physician who is primarily engaged in the
807	treatment of pain by prescribing or dispensing controlled
808	substance medications,
809	2.  Each pain-management clinic must register with the
810	department unless:
811	a.1.  That clinic is licensed as a facility pursuant to
812	chapter 395;
813	b.2.  The majority of the physicians who provide services
814	in the clinic primarily provide surgical services;
815	c.3.  The clinic is owned by a publicly held corporation
816	whose shares are traded on a national exchange or on the over-
817	the-counter market and whose total assets at the end of the
818	corporation's most recent fiscal quarter exceeded $50 million;
819	d.4.  The clinic is affiliated with an accredited medical
820	school at which training is provided for medical students,
821	residents, or fellows;
822	e.5.  The clinic does not prescribe or dispense controlled
823	substances for the treatment of pain; or
824	f.6.  The clinic is owned by a corporate entity exempt from
825	federal taxation under 26 U.S.C. s. 501(c)(3); or
826	g.  The clinic is wholly owned and operated by a board-
827	certified anesthesiologist, physiatrist, neurologist, or another
828	medical specialist who has completed a fellowship in pain
829	medicine approved by the Accreditation Council for Graduate
830	Medical Education or who is board certified in pain medicine by
831	a board approved by the American Board of Medical Specialties,
832	and that medical specialist performs interventional pain
833	procedures of the type routinely billed using surgical codes, or
834	the clinic is wholly owned and operated by a group of such
835	specialists.
836	(b)  Each clinic location shall be registered separately
837	regardless of whether the clinic is operated under the same
838	business name or management as another clinic.
839	(c)  As a part of registration, a clinic must designate an
840	osteopathic physician who is responsible for complying with all
841	requirements related to registration and operation of the clinic
842	in compliance with this section. Within 10 days after
843	termination of a designated osteopathic physician, the clinic
844	must notify the department of the identity of another designated
845	physician for that clinic. The designated physician shall have a
846	full, active, and unencumbered license under chapter 458 or this
847	chapter and shall practice at the clinic location for which the
848	physician has assumed responsibility. Failing to have a licensed
849	designated osteopathic physician practicing at the location of
850	the registered clinic may be the basis for a summary suspension
851	of the clinic registration certificate as described in s.
852	456.073(8) for a license or s. 120.60(6).
853	(d)  The department shall deny registration to any clinic
854	that is not fully owned by a physician licensed under chapter
855	458 or this chapter or a group of physicians, each of whom is
856	licensed under chapter 458 or this chapter; or that is not a
857	health care clinic licensed under part X of chapter 400.
858	(e)  The department shall deny registration to any pain-
859	management clinic owned by or with any contractual or employment
860	relationship with a physician:
861	1.  Whose Drug Enforcement Administration number has ever
862	been revoked.
863	2.  Whose application for a license to prescribe, dispense,
864	or administer a controlled substance has been denied by any
865	jurisdiction.
866	3.  Who has been convicted of or pleaded guilty or nolo
867	contendere to, regardless of adjudication, an offense that
868	constitutes a felony for receipt of illicit and diverted drugs,
869	including a controlled substance listed in Schedule I, Schedule
870	II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
871	this state, any other state, or the United States.
872	(f)  If the department finds that a pain-management clinic
873	does not meet the requirement of paragraph (d) or is owned,
874	directly or indirectly, by a person meeting any criteria listed
875	in paragraph (e), the department shall revoke the certificate of
876	registration previously issued by the department. As determined
877	by rule, the department may grant an exemption to denying a
878	registration or revoking a previously issued registration if
879	more than 10 years have elapsed since adjudication. As used in
880	this subsection, the term "convicted" includes an adjudication
881	of guilt following a plea of guilty or nolo contendere or the
882	forfeiture of a bond when charged with a crime.
883	(g)  The department may revoke the clinic's certificate of
884	registration and prohibit all physicians associated with that
885	pain-management clinic from practicing at that clinic location
886	based upon an annual inspection and evaluation of the factors
887	described in subsection (3).
888	(h)  If the registration of a pain-management clinic is
889	revoked or suspended, the designated physician of the pain-
890	management clinic, the owner or lessor of the pain-management
891	clinic property, the manager, and the proprietor shall cease to
892	operate the facility as a pain-management clinic as of the
893	effective date of the suspension or revocation.
894	(i)  If a pain-management clinic registration is revoked or
895	suspended, the designated physician of the pain-management
896	clinic, the owner or lessor of the clinic property, the manager,
897	or the proprietor is responsible for removing all signs and
898	symbols identifying the premises as a pain-management clinic.
899	(j)  Upon the effective date of the suspension or
900	revocation, the designated physician of the pain-management
901	clinic shall advise the department of the disposition of the
902	medicinal drugs located on the premises. The disposition is
903	subject to the supervision and approval of the department.
904	Medicinal drugs that are purchased or held by a pain-management
905	clinic that is not registered may be deemed adulterated pursuant
906	to s. 499.006.
907	(k)  If the clinic's registration is revoked, any person
908	named in the registration documents of the pain-management
909	clinic, including persons owning or operating the pain-
910	management clinic, may not, as an individual or as a part of a
911	group, make application for a permit to operate a pain-
912	management clinic for 5 years after the date the registration is
913	revoked.
914	(l)  The period of suspension for the registration of a
915	pain-management clinic shall be prescribed by the department,
916	but may not exceed 1 year.
917	(m)  A change of ownership of a registered pain-management
918	clinic requires submission of a new registration application.
919	(2)  PHYSICIAN RESPONSIBILITIES.-These responsibilities
920	apply to any osteopathic physician who provides professional
921	services in a pain-management clinic that is required to be
922	registered in subsection (1).
923	(a)  An osteopathic physician may not practice medicine in
924	a pain-management clinic, as described in subsection (4), if:
925	1.  The pain-management clinic is not registered with the
926	department as required by this section; or
927	2.  Effective July 1, 2012, the physician has not
928	successfully completed a pain-medicine fellowship that is
929	accredited by the Accreditation Council for Graduate Medical
930	Education or the American Osteopathic Association or a pain-
931	medicine residency that is accredited by the Accreditation
932	Council for Graduate Medical Education or the American
933	Osteopathic Association or, prior to July 1, 2012, does not
934	comply with rules adopted by the board.
935
936	Any physician who qualifies to practice medicine in a pain-
937	management clinic pursuant to rules adopted by the Board of
938	Osteopathic Medicine as of July 1, 2012, may continue to
939	practice medicine in a pain-management clinic as long as the
940	physician continues to meet the qualifications set forth in the
941	board rules. An osteopathic physician who violates this
942	paragraph is subject to disciplinary action by his or her
943	appropriate medical regulatory board.
944	(b)  A person may not dispense any medication, including a
945	controlled substance, on the premises of a registered pain-
946	management clinic unless he or she is a physician licensed under
947	this chapter or chapter 458.
948	(c)  An osteopathic physician must perform a physical
949	examination of a patient on the same day that he or she
950	dispenses or prescribes a controlled substance to a patient at a
951	pain-management clinic. If the osteopathic physician prescribes
952	or dispenses more than a 72-hour dose of controlled substances
953	for the treatment of chronic nonmalignant pain, the osteopathic
954	physician must document in the patient's record the reason for
955	prescribing or dispensing that quantity.
956	(d)  An osteopathic physician authorized to prescribe
957	controlled substances who practices at a pain-management clinic
958	is responsible for maintaining the control and security of his
959	or her prescription blanks and any other method used for
960	prescribing controlled substance pain medication. The
961	osteopathic physician shall comply with the requirements for
962	counterfeit-resistant prescription blanks in s. 893.065 and the
963	rules adopted pursuant to that section. The osteopathic
964	physician shall notify, in writing, the department within 24
965	hours following any theft or loss of a prescription blank or
966	breach of any other method for prescribing pain medication.
967	(e)  The designated osteopathic physician of a pain-
968	management clinic shall notify the applicable board in writing
969	of the date of termination of employment within 10 days after
970	terminating his or her employment with a pain-management clinic
971	that is required to be registered under subsection (1). Each
972	osteopathic physician practicing in a pain-management clinic
973	shall advise the Board of Osteopathic Medicine in writing within
974	10 calendar days after beginning or ending his or her practice
975	at a pain-management clinic.
976	(f)  Each osteopathic physician practicing in a pain
977	management clinic is responsible for ensuring compliance with
978	the following facility and physical operations requirements:
979	1.  A pain-management clinic shall be located and operated
980	at a publicly accessible fixed location and must:
981	a.  Display a sign that can be viewed by the public that
982	contains the clinic name, hours of operations, and a street
983	address.
984	b.  Have a publicly listed telephone number and a dedicated
985	phone number to send and receive faxes with a fax machine that
986	shall be operational 24 hours per day.
987	c.  Have emergency lighting and communications.
988	d.  Have a reception and waiting area.
989	e.  Provide a restroom.
990	f.  Have an administrative area including room for storage
991	of medical records, supplies and equipment.
992	g.  Have private patient examination rooms.
993	h.  Have treatment rooms, if treatment is being provided to
994	the patient.
995	i.  Display a printed sign located in a conspicuous place
996	in the waiting room viewable by the public with the name and
997	contact information of the clinic-designated physician and the
998	names of all physicians practicing in the clinic.
999	j.  If the clinic stores and dispenses prescription drug,
1000	comply with ss. 499.0121 and 893.07.
1001	2.  This section does not excuse an osteopathic physician
1002	from providing any treatment or performing any medical duty
1003	without the proper equipment and materials as required by the
1004	standard of care. This section does not supersede the level of
1005	care, skill, and treatment recognized in general law related to
1006	healthcare licensure.
1007	(g)  Each osteopathic physician practicing in a pain
1008	management clinic is responsible for ensuring compliance with
1009	the following infection control requirements.
1010	1.  The clinic shall maintain equipment and supplies to
1011	support infection prevention and control activities.
1012	2.  The clinic shall identify infection risks based on the
1013	following:
1014	a.  Geographic location, community, and population served.
1015	b.  The care, treatment and services it provides.
1016	c.  An analysis of its infection surveillance and control
1017	data.
1018	3.  The clinic shall maintain written infection prevention
1019	policies and procedures that address the following:
1020	a.  Prioritized risks.
1021	b.  Limiting unprotected exposure to pathogen.
1022	c.  Limiting the transmission of infections associated with
1023	procedures performed in the clinic.
1024	d.  Limiting the transmission of infections associated with
1025	the clinic's use of medical equipment, devices, and supplies.
1026	(h)  Each osteopathic physician practicing in a pain
1027	management clinic is responsible for ensuring compliance with
1028	the following health and safety requirements.
1029	1.  The clinic, including its grounds, buildings,
1030	furniture, appliances, and equipment shall be structurally
1031	sound, in good repair, clean, and free from health and safety
1032	hazards.
1033	2.  The clinic shall have evacuation procedures in the
1034	event of an emergency which shall include provisions for the
1035	evacuation of disabled patients and employees.
1036	3.  The clinic shall have a written facility-specific
1037	disaster plan which sets forth actions that will be taken in the
1038	event of clinic closure due to unforeseen disasters and shall
1039	include provisions for the protection of medical records and any
1040	controlled substances.
1041	4.  Each clinic shall have at least one employee on the
1042	premises during patient care hours who is certified in Basic
1043	Life Support and is trained in reacting to accidents and medical
1044	emergencies until emergency medical personnel arrive.
1045	(i)  The designated physician is responsible for ensuring
1046	compliance with the following quality assurance requirements.
1047	Each pain management clinic shall have an ongoing quality
1048	assurance program that objectively and systematically monitors
1049	and evaluates the quality and appropriateness of patient care,
1050	evaluates methods to improve patient care, identifies and
1051	corrects deficiencies within the facility, alerts the designated
1052	physician to identify and resolve recurring problems, and
1053	provides for opportunities to improve the facility's performance
1054	and to enhance and improve the quality of care provided to the
1055	public. The designated physician shall establish a quality
1056	assurance program that includes the following components:
1057	1.  The identification, investigation, and analysis of the
1058	frequency and causes of adverse incidents to patients.
1059	2.  The identification of trends or patterns of incidents.
1060	3.  The development of measures to correct, reduce,
1061	minimize, or eliminate the risk of adverse incidents to
1062	patients.
1063	4.  The documentation of these functions and periodic
1064	review no less than quarterly of such information by the
1065	designated physician.
1066	(j)  The designated physician is responsible for ensuring
1067	compliance with the following data collection and reporting
1068	requirements:
1069	1.  The designated physician for each pain-management
1070	clinic shall report all adverse incidents to the department as
1071	set forth in s. 459.026.
1072	2.  The designated physician shall also report to the Board
1073	of Osteopathic Medicine, in writing, on a quarterly basis, the
1074	following data:
1075	a.  Number of new and repeat patients seen and treated at
1076	the clinic who are prescribed controlled substance medications
1077	for the treatment of chronic, nonmalignant pain.
1078	b.  The number of patients discharged due to drug abuse.
1079	c.  The number of patients discharged due to drug
1080	diversion.
1081	d.  The number of patients treated at the pain clinic whose
1082	domicile is located somewhere other than in this state. A
1083	patient's domicile is the patient's fixed or permanent home to
1084	which he or she intends to return even though he or she may
1085	temporarily reside elsewhere.
1086	(3)  INSPECTION.-
1087	(a)  The department shall inspect the pain-management
1088	clinic annually, including a review of the patient records, to
1089	ensure that it complies with this section and the rules of the
1090	Board of Osteopathic Medicine adopted pursuant to subsection (4)
1091	unless the clinic is accredited by a nationally recognized
1092	accrediting agency approved by the Board of Osteopathic
1093	Medicine.
1094	(b)  During an onsite inspection, the department shall make
1095	a reasonable attempt to discuss each violation with the owner or
1096	designated physician of the pain-management clinic before
1097	issuing a formal written notification.
1098	(c)  Any action taken to correct a violation shall be
1099	documented in writing by the owner or designated physician of
1100	the pain-management clinic and verified by followup visits by
1101	departmental personnel.
1102	(4)  RULEMAKING.-
1103	(a)  The department shall adopt rules necessary to
1104	administer the registration and inspection of pain-management
1105	clinics which establish the specific requirements, procedures,
1106	forms, and fees.
1107	(b)  The department shall adopt a rule defining what
1108	constitutes practice by a designated osteopathic physician at
1109	the clinic location for which the physician has assumed
1110	responsibility, as set forth in subsection (1). When adopting
1111	the rule, the department shall consider the number of clinic
1112	employees, the location of the pain-management clinic, the
1113	clinic's hours of operation, and the amount of controlled
1114	substances being prescribed, dispensed, or administered at the
1115	pain-management clinic.
1116	(c)  The Board of Osteopathic Medicine shall adopt a rule
1117	establishing the maximum number of prescriptions for Schedule II
1118	or Schedule III controlled substances or the controlled
1119	substance Alprazolam which may be written at any one registered
1120	pain-management clinic during any 24-hour period.
1121	(b)(d)  The Board of Osteopathic Medicine shall adopt rules
1122	setting forth standards of practice for osteopathic physicians
1123	practicing in privately owned pain-management clinics that
1124	primarily engage in the treatment of pain by prescribing or
1125	dispensing controlled substance medications. Such rules shall
1126	address, but need not be limited to:
1127	1.  Facility operations;
1128	2.  Physical operations;
1129	3.  Infection control requirements;
1130	4.  Health and safety requirements;
1131	5.  Quality assurance requirements;
1132	6.  Patient records;
1133	7.  training requirements for all facility health care
1134	practitioners who are not regulated by another board.;
1135	8.  Inspections; and
1136	9.  Data collection and reporting requirements.
1137
1138	An osteopathic physician is primarily engaged in the treatment
1139	of pain by prescribing or dispensing controlled substance
1140	medications when the majority of the patients seen are
1141	prescribed or dispensed controlled substance medications for the
1142	treatment of chronic nonmalignant pain. Chronic nonmalignant
1143	pain is pain unrelated to cancer which persists beyond the usual
1144	course of the disease or the injury that is the cause of the
1145	pain or more than 90 days after surgery.
1146	(5)  PENALTIES; ENFORCEMENT.-
1147	(a)  The department may impose an administrative fine on
1148	the clinic of up to $5,000 per violation for violating the
1149	requirements of this section; chapter 499, the Florida Drug and
1150	Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
1151	Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
1152	Abuse Prevention and Control Act; chapter 893, the Florida
1153	Comprehensive Drug Abuse Prevention and Control Act; or the
1154	rules of the department. In determining whether a penalty is to
1155	be imposed, and in fixing the amount of the fine, the department
1156	shall consider the following factors:
1157	1.  The gravity of the violation, including the probability
1158	that death or serious physical or emotional harm to a patient
1159	has resulted, or could have resulted, from the pain-management
1160	clinic's actions or the actions of the osteopathic physician,
1161	the severity of the action or potential harm, and the extent to
1162	which the provisions of the applicable laws or rules were
1163	violated.
1164	2.  What actions, if any, the owner or designated
1165	osteopathic physician took to correct the violations.
1166	3.  Whether there were any previous violations at the pain-
1167	management clinic.
1168	4.  The financial benefits that the pain-management clinic
1169	derived from committing or continuing to commit the violation.
1170	(b)  Each day a violation continues after the date fixed
1171	for termination of the violation as ordered by the department
1172	constitutes an additional, separate, and distinct violation.
1173	(c)  The department may impose a fine and, in the case of
1174	an owner-operated pain-management clinic, revoke or deny a pain-
1175	management clinic's registration, if the clinic's designated
1176	osteopathic physician knowingly and intentionally misrepresents
1177	actions taken to correct a violation.
1178	(d)  An owner or designated osteopathic physician of a
1179	pain-management clinic who concurrently operates an unregistered
1180	pain-management clinic is subject to an administrative fine of
1181	$5,000 per day.
1182	(e)  If the owner of a pain-management clinic that requires
1183	registration fails to apply to register the clinic upon a change
1184	of ownership and operates the clinic under the new ownership,
1185	the owner is subject to a fine of $5,000.
1186	(6)  EXPIRATION.-This section expires January 1, 2016.
1187	Section 8.  Paragraph (f) is added to subsection (1) of
1188	section 459.013, Florida Statutes, to read:
1189	459.013  Penalty for violations.-
1190	(1)  Each of the following acts constitutes a felony of the
1191	third degree, punishable as provided in s. 775.082, s. 775.083,
1192	or s. 775.084:
1193	(f)  Dispensing a controlled substance listed in Schedule
1194	II or Schedule III in violation of s. 465.0276.
1195	Section 9.  Paragraph (tt) is added to subsection (1) of
1196	section 459.015, Florida Statutes, to read:
1197	459.015  Grounds for disciplinary action; action by the
1198	board and department.-
1199	(1)  The following acts constitute grounds for denial of a
1200	license or disciplinary action, as specified in s. 456.072(2):
1201	(tt)  Dispensing a controlled substance listed in Schedule
1202	II or Schedule III in violation of s. 465.0276.
1203	Section 10.  Subsections (3) and (4) of section 465.015,
1204	Florida Statutes, are renumbered as subsections (4) and (5),
1205	respectively, a new subsection (3) is added to that section, and
1206	present subsection (4) of that section is amended, to read:
1207	465.015  Violations and penalties.-
1208	(3)  It is unlawful for any pharmacist to fail to report to
1209	the sheriff of the county where the pharmacy is located within
1210	24 hours after learning of any instance in which a person
1211	obtained or attempted to obtain a controlled substance, as
1212	defined in s. 893.02, that the pharmacist knew or reasonably
1213	should have known was obtained or attempted to be obtained from
1214	the pharmacy through fraudulent methods or representations. Any
1215	pharmacist who fails to make such a report within 24 hours after
1216	learning of the fraud or attempted fraud commits a misdemeanor
1217	of the first degree, punishable as provided in s. 775.082 or s.
1218	775.083. A sufficient report of the fraudulent obtaining of
1219	controlled substances under this subsection shall contain, at a
1220	minimum, a copy of the prescription used or presented and a
1221	narrative, including all information available to the pharmacy
1222	concerning the transaction, such as the name and telephone
1223	number of the prescribing physician; the name, description, and
1224	any personal identification information pertaining to the person
1225	who presented the prescription; and all other material
1226	information, such as photographic or video surveillance of the
1227	transaction.
1228	(5)(4)  Any person who violates any provision of subsection
1229	(1) or subsection (4) (3) commits a misdemeanor of the first
1230	degree, punishable as provided in s. 775.082 or s. 775.083. Any
1231	person who violates any provision of subsection (2) commits a
1232	felony of the third degree, punishable as provided in s.
1233	775.082, s. 775.083, or s. 775.084. In any warrant, information,
1234	or indictment, it shall not be necessary to negative any
1235	exceptions, and the burden of any exception shall be upon the
1236	defendant.
1237	Section 11.  Paragraph (t) is added to subsection (1) of
1238	section 465.016, Florida Statutes, to read:
1239	465.016  Disciplinary actions.-
1240	(1)  The following acts constitute grounds for denial of a
1241	license or disciplinary action, as specified in s. 456.072(2):
1242	(t)  Committing an error or omission during the performance
1243	of a specific function of prescription drug processing, which
1244	includes, for purposes of this paragraph:
1245	1.  Receiving, interpreting, or clarifying a prescription.
1246	2.  Entering prescription data into the pharmacy's record.
1247	3.  Verifying or validating a prescription.
1248	4.  Performing pharmaceutical calculations.
1249	5.  Performing prospective drug review as defined by the
1250	board.
1251	6.  Obtaining refill and substitution authorizations.
1252	7.  Interpreting or acting on clinical data.
1253	8.  Performing therapeutic interventions.
1254	9.  Providing drug information concerning a patient's
1255	prescription.
1256	10.  Providing patient counseling.
1257	Section 12.  Section 465.018, Florida Statutes, is amended
1258	to read:
1259	465.018  Community pharmacies; permits.-
1260	(1)  Any person desiring a permit to operate a community
1261	pharmacy shall apply to the department.
1262	(2)  If the board office certifies that the application
1263	complies with the laws of the state and the rules of the board
1264	governing pharmacies, the department shall issue the permit. No
1265	permit shall be issued unless a licensed pharmacist is
1266	designated as the prescription department manager responsible
1267	for maintaining all drug records, providing for the security of
1268	the prescription department, and following such other rules as
1269	relate to the practice of the profession of pharmacy. The
1270	permittee and the newly designated prescription department
1271	manager shall notify the department within 10 days of any change
1272	in prescription department manager.
1273	(3)  The board may suspend or revoke the permit of, or may
1274	refuse to issue a permit to:
1275	(a)  Any person who has been disciplined or who has
1276	abandoned a permit or allowed a permit to become void after
1277	written notice that disciplinary proceedings had been or would
1278	be brought against the permit;
1279	(b)  Any person who is an officer, director, or person
1280	interested directly or indirectly in a person or business entity
1281	that has had a permit disciplined or abandoned or become void
1282	after written notice that disciplinary proceedings had been or
1283	would be brought against the permit; or
1284	(c)  Any person who is or has been an officer of a business
1285	entity, or who was interested directly or indirectly in a
1286	business entity, the permit of which has been disciplined or
1287	abandoned or become null and void after written notice that
1288	disciplinary proceedings had been or would be brought against
1289	the permit.
1290	(4)  In addition to any other remedies provided by law, the
1291	board may deny the application or suspend or revoke the license,
1292	registration, or certificate of any entity regulated or licensed
1293	by it if the applicant, licensee, registrant, or licenseholder,
1294	or, in the case of a corporation, partnership, or other business
1295	entity, if any officer, director, agent, or managing employee of
1296	that business entity or any affiliated person, partner, or
1297	shareholder having an ownership interest equal to 5 percent or
1298	greater in that business entity, has failed to pay all
1299	outstanding fines, liens, or overpayments assessed by final
1300	order of the department, unless a repayment plan is approved by
1301	the department; or for failure to comply with any repayment
1302	plan.
1303	(5)  In reviewing any application requesting a change of
1304	ownership or a change of licensee or registrant, the transferor
1305	shall, before board approval of the change, repay or make
1306	arrangements to repay any amounts owed to the department. If the
1307	transferor fails to repay or make arrangements to repay the
1308	amounts owed to the department, the license or registration may
1309	not be issued to the transferee until repayment or until
1310	arrangements for repayment are made.
1311	(6)  Passing an onsite inspection is a prerequisite to the
1312	issuance of an initial permit or a permit for a change of
1313	location. The department must make the inspection within 90 days
1314	before issuance of the permit.
1315	(7)  Effective January 1, 2012, a pharmacy permitted under
1316	this section may not dispense a controlled substance listed in
1317	Schedule II or Schedule III as provided in s. 893.03 unless the
1318	pharmacy:
1319	(a)  Is wholly owned by a corporation whose shares are
1320	publicly traded on a recognized stock exchange;
1321	(b)  Is wholly owned by a corporation having more than $100
1322	million of business taxable assets in this state;
1323	(c)  Is wholly owned or operated by a licensed hospice,
1324	hospital, or nursing facility, or provides services exclusively
1325	to patients of a licensed hospice, hospital, or nursing
1326	facility;
1327	(d)  Has been continuously permitted for at least 10 years;
1328	or
1329	(e)  Received or renewed a permit pursuant to the
1330	requirements of this chapter.
1331
1332	Community pharmacies that dispense controlled substances must
1333	maintain a record of all controlled substance dispensing
1334	consistent with the requirements of s. 893.07 and must make the
1335	record available to the department and law enforcement agencies
1336	upon request.
1337	Section 13.  Section 465.022, Florida Statutes, is amended
1338	to read:
1339	465.022  Pharmacies; general requirements; fees.-
1340	(1)  The board shall adopt rules pursuant to ss. 120.536(1)
1341	and 120.54 to implement the provisions of this chapter. Such
1342	rules shall include, but shall not be limited to, rules relating
1343	to:
1344	(a)  General drug safety measures.
1345	(b)  Minimum standards for the physical facilities of
1346	pharmacies.
1347	(c)  Safe storage of floor-stock drugs.
1348	(d)  Functions of a pharmacist in an institutional
1349	pharmacy, consistent with the size and scope of the pharmacy.
1350	(e)  Procedures for the safe storage and handling of
1351	radioactive drugs.
1352	(f)  Procedures for the distribution and disposition of
1353	medicinal drugs distributed pursuant to s. 499.028.
1354	(g)  Procedures for transfer of prescription files and
1355	medicinal drugs upon the change of ownership or closing of a
1356	pharmacy.
1357	(h)  Minimum equipment which a pharmacy shall at all times
1358	possess to fill prescriptions properly.
1359	(i)  Procedures for the dispensing of controlled substances
1360	to minimize dispensing based on fraudulent representations or
1361	invalid practitioner-patient relationships.
1362	(2)  A pharmacy permit may shall be issued only to a
1363	natural person who is at least 18 years of age, to a partnership
1364	comprised of at least one natural person and all of whose
1365	partners are all at least 18 years of age, to a government
1366	agency, or to a business entity that is properly registered with
1367	the Secretary of State, if required by law, and has been issued
1368	a federal employer tax identification number corporation that is
1369	registered pursuant to chapter 607 or chapter 617 whose
1370	officers, directors, and shareholders are at least 18 years of
1371	age. Permits issued to business entities may be issued only to
1372	entities whose affiliated persons, members, partners, officers,
1373	directors, and agents, including persons required to be
1374	fingerprinted under subsection (3), are not less than 18 years
1375	of age.
1376	(3)  Any person or business entity, partnership, or
1377	corporation before engaging in the operation of a pharmacy,
1378	shall file with the board a sworn application on forms provided
1379	by the department. For purposes of this section, any person
1380	required to provide fingerprints under this subsection is an
1381	affiliated person within the meaning of s. 465.023(1).
1382	(a)  An application for a pharmacy permit must include a
1383	set of fingerprints from each person having an ownership
1384	interest of 5 percent or greater and from any person who,
1385	directly or indirectly, manages, oversees, or controls the
1386	operation of the applicant, including officers and members of
1387	the board of directors of an applicant that is a corporation.
1388	The applicant must provide payment in the application for the
1389	cost of state and national criminal history records checks.
1390	1.  For corporations having more than $100 million of
1391	business taxable assets in this state, in lieu of these
1392	fingerprint requirements, the department shall require the
1393	prescription department manager or consultant pharmacist of
1394	record who will be directly involved in the management and
1395	operation of the pharmacy to submit a set of fingerprints.
1396	2.  A representative of a corporation described in
1397	subparagraph 1. satisfies the requirement to submit a set of his
1398	or her fingerprints if the fingerprints are on file with the
1399	department or the Agency for Health Care Administration, meet
1400	the fingerprint specifications for submission by the Department
1401	of Law Enforcement, and are available to the department.
1402	(b)  The department shall submit the fingerprints provided
1403	by the applicant to the Department of Law Enforcement for a
1404	state criminal history records check. The Department of Law
1405	Enforcement shall forward the fingerprints to the Federal Bureau
1406	of Investigation for a national criminal history records check.
1407	(c)  In addition to those documents required by the
1408	department or board, each applicant with any financial or
1409	ownership interest greater than 5 percent in the subject of the
1410	application must submit a signed affidavit disclosing any
1411	financial or ownership interest greater than 5 percent in any
1412	pharmacy permitted in the past 5 years, which pharmacy has
1413	closed voluntarily or involuntarily, has filed a voluntary
1414	relinquishment of its permit, has had its permit suspended or
1415	revoked, or has had an injunction issued against it by a
1416	regulatory agency. The affidavit must disclose the reason such
1417	entity was closed, whether voluntary or involuntary.
1418	(4)  An application for a pharmacy permit must include the
1419	applicant's written policies and procedures for preventing
1420	controlled substance dispensing based on fraudulent
1421	representations or invalid practitioner-patient relationships.
1422	The board must review the policies and procedures and may deny a
1423	permit if the policies and procedures are insufficient to
1424	reasonably prevent such dispensing.
1425	(5)(4)  The department or board shall deny an application
1426	for a pharmacy permit if the applicant or an affiliated person,
1427	partner, officer, director, or prescription department manager
1428	or consultant pharmacist of record of the applicant has:
1429	(a)  Has obtained a permit by misrepresentation or fraud.;
1430	(b)  Has attempted to procure, or has procured, a permit
1431	for any other person by making, or causing to be made, any false
1432	representation.;
1433	(c)  Has been convicted of, or entered a plea of guilty or
1434	nolo contendere to, regardless of adjudication, a crime in any
1435	jurisdiction which relates to the practice of, or the ability to
1436	practice, the profession of pharmacy.;
1437	(d)  Has been convicted of, or entered a plea of guilty or
1438	nolo contendere to, regardless of adjudication, a crime in any
1439	jurisdiction which relates to health care fraud.;
1440	(e)  Has been convicted of, or entered a plea of guilty or
1441	nolo contendere to, regardless of adjudication, a felony under
1442	chapter 409, chapter 817, or chapter 893, or a similar felony
1443	offense committed in another state or jurisdiction, since July
1444	1, 2009. Been terminated for cause, pursuant to the appeals
1445	procedures established by the state or Federal Government, from
1446	any state Medicaid program or the federal Medicare program,
1447	unless the applicant has been in good standing with a state
1448	Medicaid program or the federal Medicare program for the most
1449	recent 5 years and the termination occurred at least 20 years
1450	ago; or
1451	(f)  Has been convicted of, or entered a plea of guilty or
1452	nolo contendere to, regardless of adjudication, a felony under
1453	21 U.S.C. ss. 801-970 or 42 U.S.C. ss. 1395-1396 since July 1,
1454	2009.
1455	(g)  Has been terminated for cause from the Florida
1456	Medicaid program pursuant to s. 409.913, unless the applicant
1457	has been in good standing with the Florida Medicaid program for
1458	the most recent 5-year period.
1459	(h)  Has been terminated for cause, pursuant to the appeals
1460	procedures established by the state, from any other state
1461	Medicaid program, unless the applicant has been in good standing
1462	with a state Medicaid program for the most recent 5-year period
1463	and the termination occurred at least 20 years before the date
1464	of the application.
1465	(i)  Is currently listed on the United States Department of
1466	Health and Human Services Office of Inspector General's List of
1467	Excluded Individuals and Entities.
1468	(j)(f)  Has dispensed any medicinal drug based upon a
1469	communication that purports to be a prescription as defined by
1470	s. 465.003(14) or s. 893.02 when the pharmacist knows or has
1471	reason to believe that the purported prescription is not based
1472	upon a valid practitioner-patient relationship that includes a
1473	documented patient evaluation, including history and a physical
1474	examination adequate to establish the diagnosis for which any
1475	drug is prescribed and any other requirement established by
1476	board rule under chapter 458, chapter 459, chapter 461, chapter
1477	463, chapter 464, or chapter 466.
1478	(k)  Has violated or failed to comply with any provision of
1479	this chapter; chapter 499, the Florida Drug and Cosmetic Act;
1480	chapter 893; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
1481	Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
1482	Abuse Prevention and Control Act; or any rules or regulations
1483	promulgated thereunder.
1484
1485	For felonies in which the defendant entered a plea of guilty or
1486	nolo contendere in an agreement with the court to enter a
1487	pretrial intervention or drug diversion program, the department
1488	may not approve or deny the application for a renewal of a
1489	license, certificate, or registration until the final resolution
1490	of the case.
1491	(6)(5)  After the application has been filed with the board
1492	and the permit fee provided in this section has been received,
1493	the board shall cause the application to be fully investigated,
1494	both as to the qualifications of the applicant and the
1495	prescription department manager or consultant pharmacist
1496	designated to be in charge and as to the premises and location
1497	described in the application.
1498	(7)(6)  The Board of Pharmacy shall have the authority to
1499	determine whether a bona fide transfer of ownership is present
1500	and that the sale of a pharmacy is not being accomplished for
1501	the purpose of avoiding an administrative prosecution.
1502	(8)(7)  Upon the completion of the investigation of an
1503	application, the board shall approve or deny disapprove the
1504	application. If approved, the permit shall be issued by the
1505	department.
1506	(9)(8)  A permittee must notify the department, on a form
1507	approved by the board, within 10 days after any change in
1508	prescription department manager or consultant pharmacist of
1509	record. Permits issued by the department are not transferable.
1510	(10)  A permittee must notify the department of the
1511	identity of the prescription department manager within 10 days
1512	after employment. The prescription department manager must
1513	comply with the following requirements:
1514	(a)  The prescription department manager of a permittee
1515	must obtain and maintain all drug records required by any state
1516	or federal law to be obtained by a pharmacy, including, but not
1517	limited to, records required by or under this chapter, chapter
1518	499, or chapter 893. The prescription department manager must
1519	ensure the permittee's compliance with all rules adopted under
1520	those chapters as they relate to the practice of the profession
1521	of pharmacy and the sale of prescription drugs.
1522	(b)  The prescription department manager must ensure the
1523	security of the prescription department. The prescription
1524	department manager must notify the board of any theft or
1525	significant loss of any controlled substances within 1 business
1526	day after discovery of the theft or loss.
1527	(c)  A registered pharmacist may not serve as the
1528	prescription department manager in more than one location unless
1529	approved by the board.
1530	(11)  The board shall adopt rules that require the keeping
1531	of such records of prescription drugs as are necessary for the
1532	protection of public health, safety, and welfare.
1533	(a)  All required records documenting prescription drug
1534	distributions shall be readily available or immediately
1535	retrievable during an inspection by the department.
1536	(b)  The records must be maintained for 4 years after the
1537	creation or receipt of the record, whichever is later.
1538	(12)  Permits issued by the department are not
1539	transferable.
1540	(13)(9)  The board shall set the fees for the following:
1541	(a)  Initial permit fee not to exceed $250.
1542	(b)  Biennial permit renewal not to exceed $250.
1543	(c)  Delinquent fee not to exceed $100.
1544	(d)  Change of location fee not to exceed $250 $100.
1545	Section 14.  Paragraph (b) of subsection (1) of section
1546	465.0276, Florida Statutes, is amended to read:
1547	465.0276  Dispensing practitioner.-
1548	(1)
1549	(b)  A practitioner registered under this section may not
1550	dispense a controlled substance listed in Schedule II or
1551	Schedule III as provided in s. 893.03 A practitioner registered
1552	under this section may not dispense more than a 72-hour supply
1553	of a controlled substance listed in Schedule II, Schedule III,
1554	Schedule IV, or Schedule V of s. 893.03 for any patient who pays
1555	for the medication by cash, check, or credit card in a clinic
1556	registered under s. 458.3265 or s. 459.0137. A practitioner who
1557	violates this paragraph commits a felony of the third degree,
1558	punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
1559	This paragraph does not apply to:
1560	1.  A practitioner who dispenses medication to a workers'
1561	compensation patient pursuant to chapter 440.
1562	2.  A practitioner who dispenses medication to an insured
1563	patient who pays by cash, check, or credit card to cover any
1564	applicable copayment or deductible.
1565	1.3.  The dispensing of complimentary packages of medicinal
1566	drugs to the practitioner's own patients in the regular course
1567	of her or his practice without the payment of a fee or
1568	remuneration of any kind, whether direct or indirect, as
1569	provided in subsection (5).
1570	2.  The dispensing of controlled substances in the health
1571	care system of the Department of Corrections.
1572	Section 15.  Subsections (16) and (17) are added to section
1573	499.0051, Florida Statutes, to read:
1574	499.0051  Criminal acts.-
1575	(16)  FALSE REPORT.-Any person who submits a report
1576	required by s. 499.0121(14) knowing that such report contains a
1577	false statement commits a felony of the third degree, punishable
1578	as provided in s. 775.082, s. 775.083, or s. 775.084.
1579	(17)  CONTROLLED SUBSTANCE DISTRIBUTION.-Any wholesale
1580	distributor who distributes controlled substances in violation
1581	of s. 499.0121(14) commits a felony of the third degree,
1582	punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
1583	In addition to any other fine that may be imposed, a wholesale
1584	distributor convicted of such a violation may be sentenced to
1585	pay a fine that does not exceed three times the gross monetary
1586	value gained from such violation, plus court costs and the
1587	reasonable costs of investigation and prosecution.
1588	Section 16.  Paragraph (o) is added to subsection (8) of
1589	section 499.012, Florida Statutes, to read:
1590	499.012  Permit application requirements.-
1591	(8)  An application for a permit or to renew a permit for a
1592	prescription drug wholesale distributor or an out-of-state
1593	prescription drug wholesale distributor submitted to the
1594	department must include:
1595	(o)  Documentation of the credentialing policies and
1596	procedures required by s. 499.0121(14).
1597	Section 17.  Subsections (14) and (15) are added to section
1598	499.0121, Florida Statutes, to read:
1599	499.0121  Storage and handling of prescription drugs;
1600	recordkeeping.-The department shall adopt rules to implement
1601	this section as necessary to protect the public health, safety,
1602	and welfare. Such rules shall include, but not be limited to,
1603	requirements for the storage and handling of prescription drugs
1604	and for the establishment and maintenance of prescription drug
1605	distribution records.
1606	(14)  DISTRIBUTION REPORTING.-Each wholesale distributor
1607	shall submit a report to the department of its receipts and
1608	distributions of controlled substances listed in Schedule II,
1609	Schedule III, Schedule IV, or Schedule V as provided in s.
1610	893.03. Wholesale distributor facilities located within this
1611	state shall report all transactions involving controlled
1612	substances, and wholesale distributor facilities located outside
1613	this state shall report all distributions to entities located in
1614	this state. If the wholesale distributor did not have any
1615	controlled substance distributions for the month, a report shall
1616	be sent indicating that no distributions occurred in the period.
1617	The report shall be submitted monthly by the 20th of the next
1618	month, in the electronic format used for controlled substance
1619	reporting to the Automation of Reports and Consolidated Orders
1620	System division of the federal Drug Enforcement Administration.
1621	Submission of electronic data must be made in a secured web
1622	environment that allows for manual or automated transmission.
1623	Upon successful transmission, an acknowledgement page must be
1624	displayed to confirm receipt. The report must contain the
1625	following information:
1626	(a)  The federal Drug Enforcement Administration
1627	registration number of the wholesale distributing location.
1628	(b)  The federal Drug Enforcement Administration
1629	registration number of the entity to which the drugs are
1630	distributed or from which the drugs are received.
1631	(c)  The transaction code that indicates the type of
1632	transaction.
1633	(d)  The National Drug Code identifier of the product and
1634	the quantity distributed or received.
1635	(e)  The Drug Enforcement Administration Form 222 number or
1636	Controlled Substance Ordering System Identifier on all schedule
1637	II transactions.
1638	(f)  The date of the transaction.
1639
1640	The department must share the reported data with the Department
1641	of Law Enforcement and local law enforcement agencies upon
1642	request and must monitor purchasing to identify purchasing
1643	levels that are inconsistent with the purchasing entity's
1644	clinical needs. The Department of Law Enforcement shall
1645	investigate purchases at levels that are inconsistent with the
1646	purchasing entity's clinical needs to determine whether
1647	violations of chapter 893 have occurred.
1648	(15)  DUE DILIGENCE OF PURCHASERS.-
1649	(a)  Each wholesale distributor must establish and maintain
1650	policies and procedures to credential physicians licensed under
1651	chapter 459, chapter 459, chapter 461, or chapter 466 and
1652	pharmacies that would purchase or otherwise receive from the
1653	wholesale distributor controlled substances listed in Schedule
1654	II or Schedule III as provided in s. 893.03. The wholesale
1655	distributor shall maintain records of such credentialing and
1656	make the records available to the department upon request. Such
1657	credentialing must, at a minimum, include:
1658	1.  A determination of the clinical nature of the receiving
1659	entity, including any specialty practice area.
1660	2.  A review of the receiving entity's history of Schedule
1661	II and Schedule III controlled substance purchasing from the
1662	wholesale distributor.
1663	3.  A determination that the receiving entity's Schedule II
1664	and Schedule III controlled substance purchasing history, if
1665	any, is consistent with and reasonable for that entity's
1666	clinical business needs.
1667	4.  Documentation of a level 2 background screening
1668	pursuant to chapter 435 through the department on any person who
1669	owns a controlling interest in or, directly or indirectly,
1670	manages, oversees, or controls the operation of the entity,
1671	including officers and members of the board of directors of an
1672	entity that is a corporation. This requirement does not apply to
1673	publicly traded entities or entities having more than $100
1674	million of business taxable assets in this state. For such
1675	entities, wholesale distributors must require current
1676	documentation of all state and federal licenses and permits.
1677	(b)  A wholesale distributor must take reasonable measures
1678	to identify its customers, understand the normal and expected
1679	transactions conducted by those customers, and identify those
1680	transactions that are suspicious in nature. A wholesale
1681	distributor must establish internal policies and procedures for
1682	identifying suspicious orders and preventing suspicious
1683	transactions. A wholesale distributor must assess orders for
1684	greater than 5,000 unit doses of any one controlled substance in
1685	any one month to determine whether the purchase is reasonable.
1686	In making such assessments, a wholesale distributor may consider
1687	the purchasing entity's clinical business needs, location, and
1688	population served, in addition to other factors established in
1689	the distributor's policies and procedures. A wholesale
1690	distributor must report to the department any regulated
1691	transaction involving an extraordinary quantity of a listed
1692	chemical, an uncommon method of payment or delivery, or any
1693	other circumstance that the regulated person believes may
1694	indicate that the listed chemical will be used in violation of
1695	the law. For each reported transaction that is completed, the
1696	wholesale distributor must document the basis for determining
1697	the transaction was reasonable.
1698	(c)  A wholesale distributor may not distribute controlled
1699	substances to an entity if any criminal history record check for
1700	any person associated with that entity shows the person has been
1701	convicted of, or entered a plea of guilty or nolo contendere to,
1702	regardless of adjudication, a crime in any jurisdiction related
1703	to controlled substances, the practice of pharmacy, or the
1704	dispensing of medicinal drugs.
1705	(d)  A wholesale distributor may not distribute more than
1706	5,000 unit doses each of hydrocodone, morphine, oxycodone,
1707	methadone, or any one benzodiazepine, or any derivative,
1708	precursor, or component of these drugs to a retail pharmacy in
1709	any given month.
1710	Section 18.  Paragraphs (o) and (p) are added to subsection
1711	(1) of section 499.05, Florida Statutes, to read:
1712	499.05  Rules.-
1713	(1)  The department shall adopt rules to implement and
1714	enforce this part with respect to:
1715	(o)  Wholesale distributor reporting requirements of s.
1716	499.0121(14).
1717	(p)  Wholesale distributor credentialing and distribution
1718	requirements of s. 499.0121(15).
1719	Section 19.  Subsections (8) and (9) are added to section
1720	499.067, Florida Statutes, to read:
1721	499.067  Denial, suspension, or revocation of permit,
1722	certification, or registration.-
1723	(8)  The department shall deny, suspend, or revoke a permit
1724	if it finds the permittee has not complied with the
1725	credentialing requirements of s. 499.0121(15).
1726	(9)  The department shall deny, suspend, or revoke a permit
1727	if it finds the permittee has not complied with the reporting
1728	requirements of, or knowingly made a false statement in a report
1729	required by, s. 499.0121(14).
1730	Section 20.  Paragraph (f) is added to subsection (3) of
1731	section 810.02, Florida Statutes, to read:
1732	810.02  Burglary.-
1733	(3)  Burglary is a felony of the second degree, punishable
1734	as provided in s. 775.082, s. 775.083, or s. 775.084, if, in the
1735	course of committing the offense, the offender does not make an
1736	assault or battery and is not and does not become armed with a
1737	dangerous weapon or explosive, and the offender enters or
1738	remains in a:
1739	(f)  Structure or conveyance when the offense intended to
1740	be committed therein is theft of a controlled substance as
1741	defined in s. 893.02. Notwithstanding any other law, separate
1742	judgments and sentences for burglary with the intent to commit
1743	theft of a controlled substance under this paragraph and for any
1744	applicable possession of controlled substance offense under s.
1745	893.13 or trafficking in controlled substance offense under s.
1746	893.135 may be imposed when all such offenses involve the same
1747	amount or amounts of a controlled substance.
1748
1749	However, if the burglary is committed within a county that is
1750	subject to a state of emergency declared by the Governor under
1751	chapter 252 after the declaration of emergency is made and the
1752	perpetration of the burglary is facilitated by conditions
1753	arising from the emergency, the burglary is a felony of the
1754	first degree, punishable as provided in s. 775.082, s. 775.083,
1755	or s. 775.084. As used in this subsection, the term "conditions
1756	arising from the emergency" means civil unrest, power outages,
1757	curfews, voluntary or mandatory evacuations, or a reduction in
1758	the presence of or response time for first responders or
1759	homeland security personnel. A person arrested for committing a
1760	burglary within a county that is subject to such a state of
1761	emergency may not be released until the person appears before a
1762	committing magistrate at a first appearance hearing. For
1763	purposes of sentencing under chapter 921, a felony offense that
1764	is reclassified under this subsection is ranked one level above
1765	the ranking under s. 921.0022 or s. 921.0023 of the offense
1766	committed.
1767	Section 21.  Paragraph (c) of subsection (2) of section
1768	812.014, Florida Statutes, is amended to read:
1769	812.014  Theft.-
1770	(2)
1771	(c)  It is grand theft of the third degree and a felony of
1772	the third degree, punishable as provided in s. 775.082, s.
1773	775.083, or s. 775.084, if the property stolen is:
1774	1.  Valued at $300 or more, but less than $5,000.
1775	2.  Valued at $5,000 or more, but less than $10,000.
1776	3.  Valued at $10,000 or more, but less than $20,000.
1777	4.  A will, codicil, or other testamentary instrument.
1778	5.  A firearm.
1779	6.  A motor vehicle, except as provided in paragraph (a).
1780	7.  Any commercially farmed animal, including any animal of
1781	the equine, bovine, or swine class, or other grazing animal, and
1782	including aquaculture species raised at a certified aquaculture
1783	facility. If the property stolen is aquaculture species raised
1784	at a certified aquaculture facility, then a $10,000 fine shall
1785	be imposed.
1786	8.  Any fire extinguisher.
1787	9.  Any amount of citrus fruit consisting of 2,000 or more
1788	individual pieces of fruit.
1789	10.  Taken from a designated construction site identified
1790	by the posting of a sign as provided for in s. 810.09(2)(d).
1791	11.  Any stop sign.
1792	12.  Anhydrous ammonia.
1793	13.  Any amount of a controlled substance as defined in s.
1794	893.02. Notwithstanding any other law, separate judgments and
1795	sentences for theft of a controlled substance under this
1796	subparagraph and for any applicable possession of controlled
1797	substance offense under s. 893.13 or trafficking in controlled
1798	substance offense under s. 893.135 may be imposed when all such
1799	offenses involve the same amount or amounts of a controlled
1800	substance.
1801
1802	However, if the property is stolen within a county that is
1803	subject to a state of emergency declared by the Governor under
1804	chapter 252, the property is stolen after the declaration of
1805	emergency is made, and the perpetration of the theft is
1806	facilitated by conditions arising from the emergency, the
1807	offender commits a felony of the second degree, punishable as
1808	provided in s. 775.082, s. 775.083, or s. 775.084, if the
1809	property is valued at $5,000 or more, but less than $10,000, as
1810	provided under subparagraph 2., or if the property is valued at
1811	$10,000 or more, but less than $20,000, as provided under
1812	subparagraph 3. As used in this paragraph, the term "conditions
1813	arising from the emergency" means civil unrest, power outages,
1814	curfews, voluntary or mandatory evacuations, or a reduction in
1815	the presence of or the response time for first responders or
1816	homeland security personnel. For purposes of sentencing under
1817	chapter 921, a felony offense that is reclassified under this
1818	paragraph is ranked one level above the ranking under s.
1819	921.0022 or s. 921.0023 of the offense committed.
1820	Section 22.  Section 893.055, Florida Statutes, is amended
1821	to read:
1822	893.055  Prescription drug monitoring program.-
1823	(1)  As used in this section, the term:
1824	(a)  "Patient advisory report" or "advisory report" means
1825	information provided by the department in writing, or as
1826	determined by the department, to a prescriber, dispenser,
1827	pharmacy, or patient concerning the dispensing of controlled
1828	substances. All advisory reports are for informational purposes
1829	only and impose no obligations of any nature or any legal duty
1830	on a prescriber, dispenser, pharmacy, or patient. The patient
1831	advisory report shall be provided in accordance with s.
1832	893.13(7)(a)8. The advisory reports issued by the department are
1833	not subject to discovery or introduction into evidence in any
1834	civil or administrative action against a prescriber, dispenser,
1835	pharmacy, or patient arising out of matters that are the subject
1836	of the report; and a person who participates in preparing,
1837	reviewing, issuing, or any other activity related to an advisory
1838	report may not be permitted or required to testify in any such
1839	civil action as to any findings, recommendations, evaluations,
1840	opinions, or other actions taken in connection with preparing,
1841	reviewing, or issuing such a report.
1842	(b)  "Controlled substance" means a controlled substance
1843	listed in Schedule II, Schedule III, or Schedule IV in s.
1844	893.03.
1845	(c)  "Dispenser" means a pharmacy, dispensing pharmacist,
1846	or dispensing health care practitioner.
1847	(d)  "Health care practitioner" or "practitioner" means any
1848	practitioner who is subject to licensure or regulation by the
1849	department under chapter 458, chapter 459, chapter 461, chapter
1850	462, chapter 464, chapter 465, or chapter 466.
1851	(e)  "Health care regulatory board" means any board for a
1852	practitioner or health care practitioner who is licensed or
1853	regulated by the department.
1854	(f)  "Pharmacy" means any pharmacy that is subject to
1855	licensure or regulation by the department under chapter 465 and
1856	that dispenses or delivers a controlled substance to an
1857	individual or address in this state.
1858	(g)  "Prescriber" means a prescribing physician,
1859	prescribing practitioner, or other prescribing health care
1860	practitioner.
1861	(h)  "Active investigation" means an investigation that is
1862	being conducted with a reasonable, good faith belief that it
1863	could lead to the filing of administrative, civil, or criminal
1864	proceedings, or that is ongoing and continuing and for which
1865	there is a reasonable, good faith anticipation of securing an
1866	arrest or prosecution in the foreseeable future.
1867	(i)  "Law enforcement agency" means the Department of Law
1868	Enforcement, a Florida sheriff's department, a Florida police
1869	department, or a law enforcement agency of the Federal
1870	Government which enforces the laws of this state or the United
1871	States relating to controlled substances, and which its agents
1872	and officers are empowered by law to conduct criminal
1873	investigations and make arrests.
1874	(j)  "Program manager" means an employee of or a person
1875	contracted by the Department of Health who is designated to
1876	ensure the integrity of the prescription drug monitoring program
1877	in accordance with the requirements established in paragraphs
1878	(2)(a) and (b).
1879	(2)(a)  By December 1, 2010, The department shall design
1880	and establish a comprehensive electronic database system that
1881	has controlled substance prescriptions provided to it and that
1882	provides prescription information to a patient's health care
1883	practitioner and pharmacist who inform the department that they
1884	wish the patient advisory report provided to them. Otherwise,
1885	the patient advisory report will not be sent to the
1886	practitioner, pharmacy, or pharmacist. The system shall be
1887	designed to provide information regarding dispensed
1888	prescriptions of controlled substances and shall not infringe
1889	upon the legitimate prescribing or dispensing of a controlled
1890	substance by a prescriber or dispenser acting in good faith and
1891	in the course of professional practice. The system shall be
1892	consistent with standards of the American Society for Automation
1893	in Pharmacy (ASAP). The electronic system shall also comply with
1894	the Health Insurance Portability and Accountability Act (HIPAA)
1895	as it pertains to protected health information (PHI), electronic
1896	protected health information (EPHI), and all other relevant
1897	state and federal privacy and security laws and regulations. The
1898	department shall establish policies and procedures as
1899	appropriate regarding the reporting, accessing the database,
1900	evaluation, management, development, implementation, operation,
1901	storage, and security of information within the system. The
1902	reporting of prescribed controlled substances shall include a
1903	dispensing transaction with a dispenser pursuant to chapter 465
1904	or through a dispensing transaction to an individual or address
1905	in this state with a pharmacy that is not located in this state
1906	but that is otherwise subject to the jurisdiction of this state
1907	as to that dispensing transaction. The reporting of patient
1908	advisory reports refers only to reports to patients, pharmacies,
1909	and practitioners. Separate reports that contain patient
1910	prescription history information and that are not patient
1911	advisory reports are provided to persons and entities as
1912	authorized in paragraphs (7)(b) and (c) and s. 893.0551.
1913	(b)  The department, when the direct support organization
1914	receives at least $20,000 in nonstate moneys or the state
1915	receives at least $20,000 in federal grants for the prescription
1916	drug monitoring program, and in consultation with the Office of
1917	Drug Control, shall adopt rules as necessary concerning the
1918	reporting, accessing the database, evaluation, management,
1919	development, implementation, operation, security, and storage of
1920	information within the system, including rules for when patient
1921	advisory reports are provided to pharmacies and prescribers. The
1922	patient advisory report shall be provided in accordance with s.
1923	893.13(7)(a)8. The department shall work with the professional
1924	health care licensure boards, such as the Board of Medicine, the
1925	Board of Osteopathic Medicine, and the Board of Pharmacy; other
1926	appropriate organizations, such as the Florida Pharmacy
1927	Association, the Office of Drug Control, the Florida Medical
1928	Association, the Florida Retail Federation, and the Florida
1929	Osteopathic Medical Association, including those relating to
1930	pain management; and the Attorney General, the Department of Law
1931	Enforcement, and the Agency for Health Care Administration to
1932	develop rules appropriate for the prescription drug monitoring
1933	program.
1934	(c)  All dispensers and prescribers subject to these
1935	reporting requirements shall be notified by the department of
1936	the implementation date for such reporting requirements.
1937	(d)  The program manager shall work with professional
1938	health care licensure boards and the stakeholders listed in
1939	paragraph (b) to develop rules appropriate for identifying
1940	indicators of controlled substance abuse.
1941	(3)  The pharmacy dispensing the controlled substance and
1942	each prescriber who directly dispenses a controlled substance
1943	shall submit to the electronic system, by a procedure and in a
1944	format established by the department and consistent with an
1945	ASAP-approved format, the following information for inclusion in
1946	the database:
1947	(a)  The name of the prescribing practitioner, the
1948	practitioner's federal Drug Enforcement Administration
1949	registration number, the practitioner's National Provider
1950	Identification (NPI) or other appropriate identifier, and the
1951	date of the prescription.
1952	(b)  The date the prescription was filled and the method of
1953	payment, such as cash by an individual, insurance coverage
1954	through a third party, or Medicaid payment. This paragraph does
1955	not authorize the department to include individual credit card
1956	numbers or other account numbers in the database.
1957	(c)  The full name, address, and date of birth of the
1958	person for whom the prescription was written.
1959	(d)  The name, national drug code, quantity, and strength
1960	of the controlled substance dispensed.
1961	(e)  The full name, federal Drug Enforcement Administration
1962	registration number, and address of the pharmacy or other
1963	location from which the controlled substance was dispensed. If
1964	the controlled substance was dispensed by a practitioner other
1965	than a pharmacist, the practitioner's full name, federal Drug
1966	Enforcement Administration registration number, and address.
1967	(f)  The name of the pharmacy or practitioner, other than a
1968	pharmacist, dispensing the controlled substance and the
1969	practitioner's National Provider Identification (NPI).
1970	(g)  Other appropriate identifying information as
1971	determined by department rule.
1972	(4)  Each time a controlled substance is dispensed to an
1973	individual, the controlled substance shall be reported to the
1974	department through the system as soon thereafter as possible,
1975	but not more than 7 15 days after the date the controlled
1976	substance is dispensed unless an extension is approved by the
1977	department for cause as determined by rule. A dispenser must
1978	meet the reporting requirements of this section by providing the
1979	required information concerning each controlled substance that
1980	it dispensed in a department-approved, secure methodology and
1981	format. Such approved formats may include, but are not limited
1982	to, submission via the Internet, on a disc, or by use of regular
1983	mail.
1984	(5)  When the following acts of dispensing or administering
1985	occur, the following are exempt from reporting under this
1986	section for that specific act of dispensing or administration:
1987	(a)  A health care practitioner when administering a
1988	controlled substance directly to a patient if the amount of the
1989	controlled substance is adequate to treat the patient during
1990	that particular treatment session.
1991	(b)  A pharmacist or health care practitioner when
1992	administering a controlled substance to a patient or resident
1993	receiving care as a patient at a hospital, nursing home,
1994	ambulatory surgical center, hospice, or intermediate care
1995	facility for the developmentally disabled which is licensed in
1996	this state.
1997	(c)  A practitioner when administering or dispensing a
1998	controlled substance in the health care system of the Department
1999	of Corrections.
2000	(d)  A practitioner when administering a controlled
2001	substance in the emergency room of a licensed hospital.
2002	(e)  A health care practitioner when administering or
2003	dispensing a controlled substance to a person under the age of
2004	16.
2005	(f)  A pharmacist or a dispensing practitioner when
2006	dispensing a one-time, 72-hour emergency resupply of a
2007	controlled substance to a patient.
2008	(6)  The department may establish when to suspend and when
2009	to resume reporting information during a state-declared or
2010	nationally declared disaster.
2011	(7)(a)  A practitioner or pharmacist who dispenses a
2012	controlled substance must submit the information required by
2013	this section in an electronic or other method in an ASAP format
2014	approved by rule of the department unless otherwise provided in
2015	this section. The cost to the dispenser in submitting the
2016	information required by this section may not be material or
2017	extraordinary. Costs not considered to be material or
2018	extraordinary include, but are not limited to, regular postage,
2019	electronic media, regular electronic mail, and facsimile
2020	charges.
2021	(b)  A pharmacy, prescriber, or dispenser shall have access
2022	to information in the prescription drug monitoring program's
2023	database which relates to a patient of that pharmacy,
2024	prescriber, or dispenser in a manner established by the
2025	department as needed for the purpose of reviewing the patient's
2026	controlled substance prescription history. Other access to the
2027	program's database shall be limited to the program's manager and
2028	to the designated program and support staff, who may act only at
2029	the direction of the program manager or, in the absence of the
2030	program manager, as authorized. Access by the program manager or
2031	such designated staff is for prescription drug program
2032	management only or for management of the program's database and
2033	its system in support of the requirements of this section and in
2034	furtherance of the prescription drug monitoring program.
2035	Confidential and exempt information in the database shall be
2036	released only as provided in paragraph (c) and s. 893.0551.
2037	(c)  The following entities shall not be allowed direct
2038	access to information in the prescription drug monitoring
2039	program database but may request from the program manager and,
2040	when authorized by the program manager, the program manager's
2041	program and support staff, information that is confidential and
2042	exempt under s. 893.0551. Prior to release, the request shall be
2043	verified as authentic and authorized with the requesting
2044	organization by the program manager, the program manager's
2045	program and support staff, or as determined in rules by the
2046	department as being authentic and as having been authorized by
2047	the requesting entity:
2048	1.  The department or its relevant health care regulatory
2049	boards responsible for the licensure, regulation, or discipline
2050	of practitioners, pharmacists, or other persons who are
2051	authorized to prescribe, administer, or dispense controlled
2052	substances and who are involved in a specific controlled
2053	substance investigation involving a designated person for one or
2054	more prescribed controlled substances.
2055	2.  The Attorney General for Medicaid fraud cases involving
2056	prescribed controlled substances.
2057	3.  A law enforcement agency during active investigations
2058	regarding potential criminal activity, fraud, or theft regarding
2059	prescribed controlled substances.
2060	4.  A patient or the legal guardian or designated health
2061	care surrogate of an incapacitated patient as described in s.
2062	893.0551 who, for the purpose of verifying the accuracy of the
2063	database information, submits a written and notarized request
2064	that includes the patient's full name, address, and date of
2065	birth, and includes the same information if the legal guardian
2066	or health care surrogate submits the request. The request shall
2067	be validated by the department to verify the identity of the
2068	patient and the legal guardian or health care surrogate, if the
2069	patient's legal guardian or health care surrogate is the
2070	requestor. Such verification is also required for any request to
2071	change a patient's prescription history or other information
2072	related to his or her information in the electronic database.
2073
2074	Information in the database for the electronic prescription drug
2075	monitoring system is not discoverable or admissible in any civil
2076	or administrative action, except in an investigation and
2077	disciplinary proceeding by the department or the appropriate
2078	regulatory board.
2079	(d)  Department staff are The following entities shall not
2080	be allowed direct access to information in the prescription drug
2081	monitoring program database but may request from the program
2082	manager and, when authorized by the program manager, the program
2083	manager's program and support staff, information that contains
2084	no identifying information of any patient, physician, health
2085	care practitioner, prescriber, or dispenser and that is not
2086	confidential and exempt,:
2087	1.  Department staff for the purpose of calculating
2088	performance measures pursuant to subsection (8).
2089	2.  The Program Implementation and Oversight Task Force for
2090	its reporting to the Governor, the President of the Senate, and
2091	the Speaker of the House of Representatives regarding the
2092	prescription drug monitoring program. This subparagraph expires
2093	July 1, 2012.
2094	(e)  All transmissions of data required by this section
2095	must comply with relevant state and federal privacy and security
2096	laws and regulations. However, any authorized agency or person
2097	under s. 893.0551 receiving such information as allowed by s.
2098	893.0551 may maintain the information received for up to 24
2099	months before purging it from his or her records or maintain it
2100	for longer than 24 months if the information is pertinent to
2101	ongoing health care or an active law enforcement investigation
2102	or prosecution.
2103	(f)  The program manager, upon determining a pattern
2104	consistent with the rules established under paragraph (2)(d) and
2105	having cause to believe a violation of s. 893.13(7)(a)8.,
2106	(8)(a), or (8)(b) has occurred, may provide relevant information
2107	to the applicable law enforcement agency.
2108	(8)  To assist in fulfilling program responsibilities,
2109	performance measures shall be reported annually to the Governor,
2110	the President of the Senate, and the Speaker of the House of
2111	Representatives by the department each December 1, beginning in
2112	2011. Data that does not contain patient, physician, health care
2113	practitioner, prescriber, or dispenser identifying information
2114	may be requested during the year by department employees so that
2115	the department may undertake public health care and safety
2116	initiatives that take advantage of observed trends. Performance
2117	measures may include, but are not limited to, efforts to achieve
2118	the following outcomes:
2119	(a)  Reduction of the rate of inappropriate use of
2120	prescription drugs through department education and safety
2121	efforts.
2122	(b)  Reduction of the quantity of pharmaceutical controlled
2123	substances obtained by individuals attempting to engage in fraud
2124	and deceit.
2125	(c)  Increased coordination among partners participating in
2126	the prescription drug monitoring program.
2127	(d)  Involvement of stakeholders in achieving improved
2128	patient health care and safety and reduction of prescription
2129	drug abuse and prescription drug diversion.
2130	(9)  Any person who willfully and knowingly fails to report
2131	the dispensing of a controlled substance as required by this
2132	section commits a misdemeanor of the first degree, punishable as
2133	provided in s. 775.082 or s. 775.083.
2134	(10)  All costs incurred by the department in administering
2135	the prescription drug monitoring program shall be funded through
2136	federal grants or private funding applied for or received by the
2137	state. The department may not commit funds for the monitoring
2138	program without ensuring funding is available. The prescription
2139	drug monitoring program and the implementation thereof are
2140	contingent upon receipt of the nonstate funding. The department
2141	and state government shall cooperate with the direct-support
2142	organization established pursuant to subsection (11) in seeking
2143	federal grant funds, other nonstate grant funds, gifts,
2144	donations, or other private moneys for the department so long as
2145	the costs of doing so are not considered material. Nonmaterial
2146	costs for this purpose include, but are not limited to, the
2147	costs of mailing and personnel assigned to research or apply for
2148	a grant. Notwithstanding the exemptions to competitive-
2149	solicitation requirements under s. 287.057(3)(f), the department
2150	shall comply with the competitive-solicitation requirements
2151	under s. 287.057 for the procurement of any goods or services
2152	required by this section. Funds provided, directly or
2153	indirectly, by prescription drug manufacturers may not be used
2154	to implement the program.
2155	(11)  The Office of Drug Control, in coordination with the
2156	department, may establish a direct-support organization that has
2157	a board consisting of at least five members to provide
2158	assistance, funding, and promotional support for the activities
2159	authorized for the prescription drug monitoring program.
2160	(a)  As used in this subsection, the term "direct-support
2161	organization" means an organization that is:
2162	1.  A Florida corporation not for profit incorporated under
2163	chapter 617, exempted from filing fees, and approved by the
2164	Department of State.
2165	2.  Organized and operated to conduct programs and
2166	activities; raise funds; request and receive grants, gifts, and
2167	bequests of money; acquire, receive, hold, and invest, in its
2168	own name, securities, funds, objects of value, or other
2169	property, either real or personal; and make expenditures or
2170	provide funding to or for the direct or indirect benefit of the
2171	department in the furtherance of the prescription drug
2172	monitoring program.
2173	(b)  The direct-support organization is not considered a
2174	lobbying firm within the meaning of s. 11.045.
2175	(c)  The State Surgeon General director of the Office of
2176	Drug Control shall appoint a board of directors for the direct-
2177	support organization. The director may designate employees of
2178	the Office of Drug Control, state employees other than state
2179	employees from the department, and any other nonstate employees
2180	as appropriate, to serve on the board. Members of the board
2181	shall serve at the pleasure of the director of the State Surgeon
2182	General Office of Drug Control. The State Surgeon General
2183	director shall provide guidance to members of the board to
2184	ensure that moneys received by the direct-support organization
2185	are not received from inappropriate sources. Inappropriate
2186	sources include, but are not limited to, donors, grantors,
2187	persons, or organizations that may monetarily or substantively
2188	benefit from the purchase of goods or services by the department
2189	in furtherance of the prescription drug monitoring program.
2190	(d)  The direct-support organization shall operate under
2191	written contract with the department Office of Drug Control. The
2192	contract must, at a minimum, provide for:
2193	1.  Approval of the articles of incorporation and bylaws of
2194	the direct-support organization by the department Office of Drug
2195	Control.
2196	2.  Submission of an annual budget for the approval of the
2197	department Office of Drug Control.
2198	3.  Certification by the department Office of Drug Control
2199	in consultation with the department that the direct-support
2200	organization is complying with the terms of the contract in a
2201	manner consistent with and in furtherance of the goals and
2202	purposes of the prescription drug monitoring program and in the
2203	best interests of the state. Such certification must be made
2204	annually and reported in the official minutes of a meeting of
2205	the direct-support organization.
2206	4.  The reversion, without penalty, to the Office of Drug
2207	Control, or to the state if the Office of Drug Control ceases to
2208	exist, of all moneys and property held in trust by the direct-
2209	support organization for the benefit of the prescription drug
2210	monitoring program if the direct-support organization ceases to
2211	exist or if the contract is terminated.
2212	5.  The fiscal year of the direct-support organization,
2213	which must begin July 1 of each year and end June 30 of the
2214	following year.
2215	6.  The disclosure of the material provisions of the
2216	contract to donors of gifts, contributions, or bequests,
2217	including such disclosure on all promotional and fundraising
2218	publications, and an explanation to such donors of the
2219	distinction between the department Office of Drug Control and
2220	the direct-support organization.
2221	7.  The direct-support organization's collecting,
2222	expending, and providing of funds to the department for the
2223	development, implementation, and operation of the prescription
2224	drug monitoring program as described in this section and s. 2,
2225	chapter 2009-198, Laws of Florida, as long as the task force is
2226	authorized. The direct-support organization may collect and
2227	expend funds to be used for the functions of the direct-support
2228	organization's board of directors, as necessary and approved by
2229	the department director of the Office of Drug Control. In
2230	addition, the direct-support organization may collect and
2231	provide funding to the department in furtherance of the
2232	prescription drug monitoring program by:
2233	a.  Establishing and administering the prescription drug
2234	monitoring program's electronic database, including hardware and
2235	software.
2236	b.  Conducting studies on the efficiency and effectiveness
2237	of the program to include feasibility studies as described in
2238	subsection (13).
2239	c.  Providing funds for future enhancements of the program
2240	within the intent of this section.
2241	d.  Providing user training of the prescription drug
2242	monitoring program, including distribution of materials to
2243	promote public awareness and education and conducting workshops
2244	or other meetings, for health care practitioners, pharmacists,
2245	and others as appropriate.
2246	e.  Providing funds for travel expenses.
2247	f.  Providing funds for administrative costs, including
2248	personnel, audits, facilities, and equipment.
2249	g.  Fulfilling all other requirements necessary to
2250	implement and operate the program as outlined in this section.
2251	(e)  The activities of the direct-support organization must
2252	be consistent with the goals and mission of the department
2253	Office of Drug Control, as determined by the office in
2254	consultation with the department, and in the best interests of
2255	the state. The direct-support organization must obtain a written
2256	approval from the department director of the Office of Drug
2257	Control for any activities in support of the prescription drug
2258	monitoring program before undertaking those activities.
2259	(f)  The Office of Drug Control, in consultation with the
2260	department, may permit, without charge, appropriate use of
2261	administrative services, property, and facilities of the Office
2262	of Drug Control and the department by the direct-support
2263	organization, subject to this section. The use must be directly
2264	in keeping with the approved purposes of the direct-support
2265	organization and may not be made at times or places that would
2266	unreasonably interfere with opportunities for the public to use
2267	such facilities for established purposes. Any moneys received
2268	from rentals of facilities and properties managed by the Office
2269	of Drug Control and the department may be held by the Office of
2270	Drug Control or in a separate depository account in the name of
2271	the direct-support organization and subject to the provisions of
2272	the letter of agreement with the department Office of Drug
2273	Control. The letter of agreement must provide that any funds
2274	held in the separate depository account in the name of the
2275	direct-support organization must revert to the department Office
2276	of Drug Control if the direct-support organization is no longer
2277	approved by the department Office of Drug Control to operate in
2278	the best interests of the state.
2279	(g)  The Office of Drug Control, in consultation with the
2280	department, may adopt rules under s. 120.54 to govern the use of
2281	administrative services, property, or facilities of the
2282	department or office by the direct-support organization.
2283	(h)  The department Office of Drug Control may not permit
2284	the use of any administrative services, property, or facilities
2285	of the state by a direct-support organization if that
2286	organization does not provide equal membership and employment
2287	opportunities to all persons regardless of race, color,
2288	religion, gender, age, or national origin.
2289	(i)  The direct-support organization shall provide for an
2290	independent annual financial audit in accordance with s.
2291	215.981. Copies of the audit shall be provided to the department
2292	Office of Drug Control and the Office of Policy and Budget in
2293	the Executive Office of the Governor.
2294	(j)  The direct-support organization may not exercise any
2295	power under s. 617.0302(12) or (16).
2296	(12)  A prescriber or dispenser may have access to the
2297	information under this section which relates to a patient of
2298	that prescriber or dispenser as needed for the purpose of
2299	reviewing the patient's controlled drug prescription history. A
2300	prescriber or dispenser acting in good faith is immune from any
2301	civil, criminal, or administrative liability that might
2302	otherwise be incurred or imposed for receiving or using
2303	information from the prescription drug monitoring program. This
2304	subsection does not create a private cause of action, and a
2305	person may not recover damages against a prescriber or dispenser
2306	authorized to access information under this subsection for
2307	accessing or failing to access such information.
2308	(13)  To the extent that funding is provided for such
2309	purpose through federal or private grants or gifts and other
2310	types of available moneys, the department, in collaboration with
2311	the Office of Drug Control, shall study the feasibility of
2312	enhancing the prescription drug monitoring program for the
2313	purposes of public health initiatives and statistical reporting
2314	that respects the privacy of the patient, the prescriber, and
2315	the dispenser. Such a study shall be conducted in order to
2316	further improve the quality of health care services and safety
2317	by improving the prescribing and dispensing practices for
2318	prescription drugs, taking advantage of advances in technology,
2319	reducing duplicative prescriptions and the overprescribing of
2320	prescription drugs, and reducing drug abuse. The requirements of
2321	the National All Schedules Prescription Electronic Reporting
2322	(NASPER) Act are authorized in order to apply for federal NASPER
2323	funding. In addition, the direct-support organization shall
2324	provide funding for the department, in collaboration with the
2325	Office of Drug Control, to conduct training for health care
2326	practitioners and other appropriate persons in using the
2327	monitoring program to support the program enhancements.
2328	(14)  A pharmacist, pharmacy, or dispensing health care
2329	practitioner or his or her agent, before releasing a controlled
2330	substance to any person not known to such dispenser, shall
2331	require the person purchasing, receiving, or otherwise acquiring
2332	the controlled substance to present valid photographic
2333	identification or other verification of his or her identity to
2334	the dispenser. If the person does not have proper
2335	identification, the dispenser may verify the validity of the
2336	prescription and the identity of the patient with the prescriber
2337	or his or her authorized agent. Verification of health plan
2338	eligibility through a real-time inquiry or adjudication system
2339	will be considered to be proper identification. This subsection
2340	does not apply in an institutional setting or to a long-term
2341	care facility, including, but not limited to, an assisted living
2342	facility or a hospital to which patients are admitted. As used
2343	in this subsection, the term "proper identification" means an
2344	identification that is issued by a state or the Federal
2345	Government containing the person's photograph, printed name, and
2346	signature or a document considered acceptable under 8 C.F.R. s.
2347	274a.2(b)(1)(v)(A) and (B).
2348	(15)  The Agency for Health Care Administration shall
2349	continue the promotion of electronic prescribing by health care
2350	practitioners, health care facilities, and pharmacies under s.
2351	408.0611.
2352	(16)  By October 1, 2010, The department shall adopt rules
2353	pursuant to ss. 120.536(1) and 120.54 to administer the
2354	provisions of this section, which shall include as necessary the
2355	reporting, accessing, evaluation, management, development,
2356	implementation, operation, and storage of information within the
2357	monitoring program's system.
2358	Section 23.  Section 893.065, Florida Statutes, is amended
2359	to read:
2360	893.065  Counterfeit-resistant prescription blanks for
2361	controlled substances listed in Schedule II, Schedule III, or
2362	Schedule IV.-The Department of Health shall develop and adopt by
2363	rule the form and content for a counterfeit-resistant
2364	prescription blank which must may be used by practitioners for
2365	the purpose of prescribing a controlled substance listed in
2366	Schedule II, Schedule III, or Schedule IV, or Schedule V
2367	pursuant to s. 456.42. The Department of Health may require the
2368	prescription blanks to be printed on distinctive, watermarked
2369	paper and to bear the preprinted name, address, and category of
2370	professional licensure of the practitioner and that
2371	practitioner's federal registry number for controlled
2372	substances. The prescription blanks may not be transferred.
2373	Section 24.  Subsections (4) and (5) of section 893.07,
2374	Florida Statutes, are amended to read:
2375	893.07  Records.-
2376	(4)  Every inventory or record required by this chapter,
2377	including prescription records, shall be maintained:
2378	(a)  Separately from all other records of the registrant,
2379	or
2380	(b)  Alternatively, in the case of Schedule III, IV, or V
2381	controlled substances, in such form that information required by
2382	this chapter is readily retrievable from the ordinary business
2383	records of the registrant.
2384
2385	In either case, the records described in this subsection shall
2386	be kept and made available for a period of at least 2 years for
2387	inspection and copying by law enforcement officers whose duty it
2388	is to enforce the laws of this state relating to controlled
2389	substances. Law enforcement officers are not required to obtain
2390	a subpoena, court order, or search warrant in order to obtain
2391	access to or copies of such records.
2392	(5)  Each person described in subsection (1) shall:
2393	(a)  Maintain a record which shall contain a detailed list
2394	of controlled substances lost, destroyed, or stolen, if any; the
2395	kind and quantity of such controlled substances; and the date of
2396	the discovering of such loss, destruction, or theft.
2397	(b)  In the event of the discovery of the theft or loss of
2398	controlled substances, report such theft or loss to the sheriff
2399	of that county within 24 hours after its discovery. A person who
2400	fails to report a theft or loss of a substance listed in s.
2401	893.03(3), (4), or (5) within 24 hours after discovery as
2402	required in this paragraph commits a misdemeanor of the second
2403	degree, punishable as provided in s. 775.082 or s. 775.083. A
2404	person who fails to report a theft or loss of a substance listed
2405	in s. 893.03(2) within 24 hours after discovery as required in
2406	this paragraph commits a misdemeanor of the first degree,
2407	punishable as provided in s. 775.082 or s. 775.083.
2408	Section 25.  Section 2 of chapter 2009-198, Laws of
2409	Florida, is repealed.
2410	Section 26.  (1)  BUY-BACK PROGRAM.-
2411	(a)  Within 10 days after the effective date of this act,
2412	each physician licensed under chapter 458, chapter 459, chapter
2413	461, or chapter 466, Florida Statutes, shall ensure that
2414	undispensed inventory of controlled substances listed in
2415	Schedule II or Schedule III as provided in s. 893.03, Florida
2416	Statutes, purchased under the physician's Drug Enforcement
2417	Administration number for dispensing is:
2418	1.  Returned to the wholesale distributor, as defined in s.
2419	499.003, Florida Statutes, which distributed them; or
2420	2.  Turned in to local law enforcement agencies and
2421	abandoned.
2422	(b)  Wholesale distributors shall buy back the undispensed
2423	inventory of controlled substances listed in Schedule II or
2424	Schedule III as provided in s. 893.03, Florida Statutes, at the
2425	purchase price paid by the physician, physician practice,
2426	clinic, or other paying entity. Each wholesale distributor shall
2427	submit a report of its activities under this section to the
2428	Department of Health by August 1, 2011. The report shall include
2429	the following information:
2430	1.  The name and address of the returning entity.
2431	2.  The Florida license, registration, or permit number and
2432	Drug Enforcement Administration number of the entity that
2433	originally ordered the drugs.
2434	3.  The drug name and number of unit doses returned.
2435	4.  The date of return.
2436	(2)  PUBLIC HEALTH EMERGENCY.-
2437	(a)  The Legislature finds that:
2438	1.  Prescription drug overdose has been declared a public
2439	health epidemic by the United States Centers for Disease Control
2440	and Prevention.
2441	2.  Prescription drug abuse results in an average of seven
2442	deaths in this state each day.
2443	3.  Physicians in this state purchased over 85 percent of
2444	the oxycodone purchased by all practitioners in the United
2445	States in 2006.
2446	4.  Physicians in this state purchased over 93 percent of
2447	the methadone purchased by all practitioners in the United
2448	States in 2006.
2449	5.  Some physicians in this state dispense medically
2450	unjustifiable amounts of controlled substances to addicts and
2451	people who intend to illegally sell the drugs.
2452	6.  Physicians in this state who have purchased large
2453	quantities of controlled substances may have significant
2454	inventory on the effective date of this act.
2455	7.  On the effective date of this act, the only legal
2456	method for a dispensing practitioner to sell or otherwise
2457	transfer controlled substances listed in Schedule II or Schedule
2458	III as provided in s. 893.03, Florida Statutes, purchased for
2459	dispensing is through the buy-back procedure or abandonment
2460	procedures of subsection (1).
2461	8.  It is likely that the same physicians who purchase and
2462	dispense medically unjustifiable amounts of drugs will not
2463	legally dispose of remaining inventory.
2464	9.  The actions of such dispensing practitioners may result
2465	in substantial injury to the public health.
2466	(b)  Immediately on the effective date of this act, the
2467	State Health Officer shall declare a public health emergency
2468	pursuant to s. 381.00315, Florida Statutes. Pursuant to that
2469	declaration, the Department of Health, the Attorney General, the
2470	Department of Law Enforcement, and local law enforcement
2471	agencies shall take the following actions:
2472	1.  Within 2 days after the effective date of this act, in
2473	consultation with wholesale distributors as defined in s.
2474	499.003, Florida Statutes, the Department of Health shall
2475	identify dispensing practitioners that purchased more than an
2476	average of 2,000 unit doses of controlled substances listed in
2477	Schedule II or Schedule III as provided in s. 893.03, Florida
2478	Statutes, per month in the previous 6 months, and shall identify
2479	the dispensing practitioners in that group who pose the greatest
2480	threat to the public health based on an assessment of:
2481	a.  The risk of noncompliance with subsection (1).
2482	b.  Purchase amounts.
2483	c.  Manner of medical practice.
2484	d.  Any other factor set by the State Health Officer.
2485
2486	The Attorney General shall consult and coordinate with federal
2487	law enforcement agencies. The Department of Law Enforcement
2488	shall coordinate the efforts of local law enforcement agencies.
2489	2.  On the 3rd day after the effective date of this act,
2490	the Department of Law Enforcement or local law enforcement
2491	agencies shall enter the business premises of the dispensing
2492	practitioners identified as posing the greatest threat to public
2493	health and quarantine the inventory of controlled substances
2494	listed in Schedule II or Schedule III as provided in s. 893.03,
2495	Florida Statutes, of such dispensing practitioners on site.
2496	3.  The Department of Law Enforcement or local law
2497	enforcement agencies shall ensure the security of such inventory
2498	24 hours a day through the 10th day after the effective date of
2499	this act or until the inventory is validly transferred pursuant
2500	to subsection (1), whichever is earlier.
2501	4.  On the 11th day after the effective date of this act,
2502	any remaining inventory of controlled substances listed in
2503	Schedule II or Schedule III as provided in s. 893.03, Florida
2504	Statutes, purchased for dispensing by practitioners is deemed
2505	contraband under s. 893.12, Florida Statutes. The Department of
2506	Law Enforcement or local law enforcement agencies shall seize
2507	the inventory and comply with the provisions of s. 893.12,
2508	Florida Statutes, to destroy it.
2509	(c)  In order to implement the provisions of this
2510	subsection, the sum of $3 million of nonrecurring funds from the
2511	General Revenue Fund is appropriated to the Department of Law
2512	Enforcement for the 2010-2011 fiscal year. The Department of Law
2513	Enforcement shall expend the appropriation by reimbursing local
2514	law enforcement agencies for the overtime-hour costs associated
2515	with securing the quarantined controlled substance inventory as
2516	provided in paragraph (b) and activities related to
2517	investigation and prosecution of crimes related to prescribed
2518	controlled substances. If requests for reimbursement exceed the
2519	amount appropriated, the reimbursements shall be prorated by the
2520	hours of overtime per requesting agency at a maximum of one law
2521	enforcement officer per quarantine site.
2522	(3)  REPEAL.-This section is repealed January 1, 2013.
2523	Section 27.  This act shall take effect July 1, 2011.

CODING: Words stricken are deletions; words underlined are additions.