HB 1147

1	A bill to be entitled
2	An act relating to pain-management clinics; providing
3	definitions; providing specific standards of practice in
4	pain-management clinics with regard to evaluations of a
5	patient's medical diagnosis, treatment plans, informed
6	consent, agreements for treatment, a physician's periodic
7	review of a patient, consultation, patient drug testing,
8	patient medical records, denial or termination of
9	controlled-substance therapy, facility and physical
10	operations, infection control, health and safety, quality
11	assurance, and data collection and reporting; amending ss.
12	458.3265 and 459.0137, F.S.; providing that the designated
13	physician at a pain-management clinic is responsible for
14	ensuring that the clinic is registered with the Department
15	of Health; requiring a pain-management clinic to notify
16	the department of the identity of a newly designated
17	physician when the former designated physician is
18	terminated or when there are any changes to the
19	registration information; providing requirements for the
20	registration of a pain-management clinic; holding
21	nationally recognized accrediting agencies to the same
22	board-determined practice standards for registering pain-
23	management clinics; requiring the department to conduct
24	unannounced annual inspections of clinics; requiring the
25	designated physician to cooperate with the department's
26	inspector and make medical records available to the
27	inspector; requiring the department's inspector to
28	determine compliance with specific standards of practice
29	in pain-management clinics; providing a procedure for when
30	a pain-management clinic is noncompliant with specific
31	standards of practice; requiring the inspector to forward
32	the written results of the inspection, deficiency notice,
33	and any subsequent documentation to the department;
34	requiring the department to review the results and
35	determine whether action against the clinic is merited;
36	providing that the department's authority is not limited
37	with regard to investigating a complaint without prior
38	notice; requiring the designated physician to submit
39	written notification of the current accreditation survey
40	of the pain-management clinic under certain circumstances;
41	requiring the designated physician to notify the Board of
42	Medicine or Board of Osteopathic Medicine of a plan of
43	correction if the pain-management clinic receives a
44	provisional or conditional accreditation; conforming
45	provisions to changes made by the act; providing an
46	effective date.
47
48	Be It Enacted by the Legislature of the State of Florida:
49
50	Section 1.  (1)  DEFINITIONS.-As used in this section, the
51	term:
52	(a)  "Controlled substance" means a substance named or
53	described in Schedule I, Schedule II, Schedule III, Schedule IV,
54	or Schedule V of s. 893.03, Florida Statutes.
55	(b)  "Controlled substance agreement" means an agreement
56	between the treating physician and the patient which establishes
57	guidelines for proper use of a controlled substance.
58	(c)  "Adverse incident" means an incident set forth in s.
59	458.351(4)(a)-(e), Florida Statutes.
60	(d)  "Board-certified pain-management physician" means a
61	physician who possesses board certification:
62	1.  By a specialty board recognized by the American Board
63	of Medical Specialties and holds a subspecialty certification in
64	pain medicine; or
65	2.  In pain medicine by the American Board of Pain
66	Medicine.
67	(e)  "Addiction medicine specialist" means:
68	1.  A board-certified psychiatrist who has a subspecialty
69	certification in addiction medicine;
70	2.  A board-certified psychiatrist who is eligible for such
71	subspecialty certification in addiction medicine; or
72	3.  A physician who specializes in addiction medicine and
73	who is certified or eligible for certification by the American
74	Society of Addiction Medicine.
75	(f)  "Mental health addiction facility" means a facility
76	licensed under chapter 394 or chapter 397, Florida Statutes.
77	(2)  STANDARDS OF PRACTICE IN PAIN-MANAGEMENT CLINICS.-
78	(a)  Evaluation of a patient's medical diagnosis.-Before a
79	physician starts a patient on any treatment, the physician shall
80	conduct a complete medical history and a physical examination
81	and document the results of the medical history and physical
82	examination in the patient's medical record. The exact
83	components of the physical examination shall be left to the
84	judgment of the physician. The physician shall document in the
85	medical record, at a minimum, the nature and intensity of the
86	pain, current and past treatments for pain, underlying or
87	coexisting diseases or conditions, the effect of the pain on
88	physical and psychological function, a review of prior medical
89	records, previous diagnostic studies, and history of alcohol and
90	substance abuse. The physician shall also document in the
91	medical record the presence of one or more recognized medical
92	indications for the use of a controlled substance.
93	(b)  Treatment plan.-The written individualized treatment
94	plan must include objectives that will be used to determine
95	treatment success, such as pain relief and improved physical and
96	psychosocial function, and indicate if any further diagnostic
97	evaluations or other treatments are planned. After treatment
98	begins, the physician shall adjust drug therapy to the
99	individual medical needs of each patient. Other treatment
100	modalities, including a rehabilitation program, shall be
101	considered depending on the etiology of the pain and the extent
102	to which the pain is associated with physical and psychosocial
103	impairment. The physician shall document the interdisciplinary
104	nature of the treatment plan.
105	(c)  Informed consent and agreement for treatment.-The
106	physician shall discuss the risks and benefits of the use of
107	controlled substances, including the risks of abuse and
108	addiction as well as physical dependence and its consequences,
109	with the patient, persons designated by the patient, or the
110	patient's surrogate or guardian if the patient is incompetent.
111	The physician shall employ the use of a written controlled
112	substance agreement with the patient which outlines the
113	patient's responsibilities, including, but not limited to:
114	1.  Drug testing of the patient and the results reviewed
115	before the initial issuance or dispensing of a controlled
116	substance prescription, and thereafter, on a random basis at
117	least twice a year and when requested by the treating physician
118	for the purpose of medical necessity and safety of any
119	controlled substances that the physician may consider
120	prescribing as part of the patient's treatment plan.
121	2.  The number and frequency of all prescription refills.
122	3.  Patient compliance and reasons for which drug therapy
123	may be discontinued.
124	4.  An agreement that controlled substances for the
125	treatment of chronic nonmalignant pain shall be prescribed by a
126	single treating physician unless otherwise authorized by the
127	treating physician and documented in the medical record.
128	(d)  Periodic review.-The physician shall see the patient
129	at regular intervals, not to exceed 3 months, to assess the
130	efficacy of treatment, ensure that controlled-substance therapy
131	continues as indicated, evaluate the patient's progress toward
132	treatment objectives, consider adverse drug effects, and review
133	the etiology of the pain. Continuation or modification of
134	therapy shall depend on the physician's evaluation of the
135	patient's progress. If treatment goals are not being achieved,
136	despite medication adjustments, the physician shall reevaluate
137	the appropriateness of continued treatment. The physician shall
138	monitor the patient's compliance in medication usage, related
139	treatment plans, controlled substance agreements, and
140	indications of substance abuse or diversion at a minimum of 3-
141	month intervals.
142	(e)  Consultation.-The physician shall refer the patient as
143	necessary for additional evaluation and treatment in order to
144	achieve treatment objectives. The physician shall give special
145	attention to those pain patients who are at risk for misusing
146	their medications and those whose living arrangements pose a
147	risk for medication misuse or diversion. The management of pain
148	in patients having a history of substance abuse or having a
149	comorbid psychiatric disorder requires extra care, monitoring,
150	and documentation, and requires consultation with or referral to
151	an addictionologist or psychiatrist.
152	(f)  Patient drug testing.-To ensure the medical necessity
153	and safety of any controlled substances that the physician may
154	consider prescribing as part of the patient's treatment plan,
155	the physician shall perform patient drug testing in accordance
156	with one of the following collection methods:
157	1.  A physician shall send the patient to a laboratory that
158	is certified by the Clinical Laboratory Improvement Amendments
159	(CLIA) or a collection site owned or operated by a CLIA-
160	certified laboratory.
161	2.  A physician shall collect in the office the patient
162	specimen to be used for drug testing in a device that measures
163	pH, specific gravity, and temperature and the specimen shall be
164	sent to a CLIA-certified laboratory. The physician shall follow
165	the collection procedures required by the agreement the pain-
166	management clinic has entered into with the CLIA-certified
167	laboratory it uses.
168	3.  The specimen shall be collected and tested in the
169	physician's office. A physician shall collect and test the
170	specimen to be used for drug testing using a CLIA-waived point-
171	of-care test or a CLIA-approved test that uses a device that
172	measures the pH, specific gravity, and temperature. Results of
173	the drug test shall be read according to the manufacturer's
174	instructions.
175
176	The treating physician shall review the results of the testing
177	before the initial issuance or dispensing of a controlled
178	substance prescription, and thereafter on a random basis at
179	least twice a year and when requested by the treating physician.
180	This paragraph does not preclude a pain-management clinic from
181	employing additional measures to ensure the integrity of the
182	urine specimens provided by patients. As used in this paragraph,
183	the term "Clinical Laboratory Improvement Amendments" or "CLIA"
184	means the amendments that were passed by Congress in 1988, 42
185	C.F.R. part 493, which established a program in which the
186	Centers for Medicare and Medicaid Services regulate all
187	laboratory testing, except research, which is performed on
188	humans in the United States by creating quality standards for
189	all laboratory testing and issuing certificates for clinical
190	laboratory testing.
191	(g)  Patient medical records.-
192	1.  The physician shall keep accurate and complete records,
193	including, but not be limited to:
194	a.  The complete medical history and a physical
195	examination, including history of drug abuse or dependence.
196	b.  Diagnostic, therapeutic, and laboratory results.
197	c.  Evaluations and consultations.
198	d.  Treatment objectives.
199	e.  Discussion of risks and benefits.
200	f.  Treatments.
201	g.  Medications, including date, type, dosage, and quantity
202	prescribed.
203	h.  Instructions and agreements.
204	i.  Periodic reviews.
205	j.  Drug testing results.
206	k.  A photocopy of the patient's government-issued photo
207	identification.
208	2.  If the treating physician gives a written prescription
209	to the patient for a controlled substance, a duplicate of the
210	prescription must be maintained in the patient's medical record.
211	3.  Each patient's medical record at a pain-management
212	clinic must contain the physician's full name presented in a
213	legible manner. In addition, each clinic must maintain a log on
214	the premises which must contain the full name, presented in a
215	legible manner, along with a corresponding sample signature and
216	initials of each physician, anesthesiologist assistant, and
217	physician assistant working in the clinic.
218	4.  Each physician at a pain-management clinic shall
219	regularly update information in each patient's medical record,
220	maintain the medical record in an accessible manner, and have
221	the medical record readily available for review. The physician
222	shall also ensure that the patient's medical record fully
223	complies with rule 64B8-9.003, Florida Administrative Code, and
224	s. 458.331(1)(m), Florida Statutes.
225	(h)  Denial or termination of controlled-substance
226	therapy.-
227	1.  If a patient's initial drug testing reflects the
228	adulteration of the specimen or the presence of illegal or
229	controlled substances, other than medications for which there
230	are approved prescriptions, or if the testing result is
231	questioned by the patient or the physician, the treating
232	physician shall send to a CLIA-certified laboratory the specimen
233	for confirmation by gas or liquid chromatography or mass
234	spectrometry. If the result of the testing of the liquid
235	chromatography or mass spectrometry is positive, the physician
236	shall refer the patient for further consultation with a board-
237	certified pain-management physician, an addiction medicine
238	specialist, or to a mental health addiction facility as it
239	pertains to drug abuse or addiction. After consultation is
240	obtained, the physician shall document in the medical record the
241	results of the consultation. The treating physician may not
242	prescribe or dispense any controlled substances until there is a
243	written concurrence of medical necessity of continued
244	controlled-substance therapy provided by a board-certified pain-
245	management physician, an addiction medicine specialist, or from
246	a mental health addiction facility. If the treating physician is
247	a board-certified pain-management physician or an addiction
248	specialist, the physician need not refer the patient for further
249	consultation. If the physician suspects diversion, the physician
250	shall discharge the patient and document all of the results of
251	testing and actions taken by the physician in the patient's
252	medical record.
253	2.  For a patient currently in treatment by the physician
254	or any other physician in the same pain-management clinic, the
255	physician shall immediately refer the patient who has signs or
256	symptoms of substance abuse to a board-certified pain-management
257	physician, an addiction medicine specialist, or a mental health
258	addiction facility as it pertains to drug abuse or addiction
259	unless the physician is board-certified or board-eligible in
260	pain management. Throughout the period before receiving the
261	consultant's report, a prescribing physician shall clearly and
262	completely document medical justification for continued
263	treatment with controlled substances and those steps taken to
264	ensure the medically appropriate use of controlled substances by
265	the patient. Upon receipt of the consultant's written report,
266	the prescribing physician shall incorporate the consultant's
267	recommendations for continuing, modifying, or discontinuing
268	controlled-substance therapy. The physician shall document the
269	resulting changes in treatment in the patient's medical record.
270	3.  For patients who are currently in treatment by the
271	physician or any other physician in the same pain-management
272	clinic, the physician shall discontinue the controlled-substance
273	therapy if the patient demonstrates evidence or behavioral
274	indications of diversion. The physician shall document all
275	results of testing and actions taken by the physician in the
276	patient's medical record.
277	(i)  Facility and physical operations.-
278	1.  A pain-management clinic must be located and operated
279	at a publicly accessible fixed location and contain:
280	a.  A sign that can be viewed by the public which contains
281	the clinic name, hours of operations, and a street address.
282	b.  A publicly listed telephone number and a dedicated
283	telephone number to send and receive facsimiles, with a
284	facsimile machine that operates 24 hours per day.
285	c.  An emergency lighting and communications system.
286	d.  A reception and waiting area.
287	e.  A restroom.
288	f.  An administrative area, including a room for storage of
289	medical records, supplies, and equipment.
290	g.  A private examination room for patients.
291	h.  A treatment room if treatment is being provided to the
292	patient.
293	i.  A printed sign located in a conspicuous place in the
294	waiting room which is viewable by the public and discloses the
295	name and contact information of the clinic's designated
296	physician and the names of each physician practicing in the
297	clinic.
298	2.  A pain-management clinic that stores and dispenses
299	prescription drugs must comply with ss. 499.0121 and 893.07,
300	Florida Statutes, and rule 64F-12.012, Florida Administrative
301	Code.
302	3.  This paragraph does not excuse a physician from
303	providing any treatment or performing any medical duty without
304	the proper equipment and materials as required by the standard
305	of care.
306	(j)  Infection control.-The designated physician at a pain-
307	management clinic shall:
308	1.  Maintain equipment and supplies to support infection
309	prevention and control activities.
310	2.  Identify infection risks based on:
311	a.  The geographic location, community, and population
312	served;
313	b.  The care, treatment, and services it provides; and
314	c.  An analysis of its infection surveillance and control
315	data.
316	3.  Maintain written infection-prevention policies and
317	procedures that address:
318	a.  The prioritized risks;
319	b.  A limitation on unprotected exposure to pathogens;
320	c.  A limitation on the transmission of infections
321	associated with procedures performed in the clinic; and
322	d.  A limitation on the transmission of infections
323	associated with the use of medical equipment, devices, and
324	supplies at the pain-management clinic.
325	(k)  Health and safety.-
326	1.  The pain-management clinic, including its grounds,
327	buildings, furniture, appliances, and equipment, must be
328	structurally sound, in good repair, clean, and free from health
329	and safety hazards.
330	2.  The pain-management clinic must have evacuation
331	procedures if an emergency occurs which include provisions for
332	the evacuation of disabled patients and employees.
333	3.  The pain-management clinic must have a written
334	facility-specific disaster plan that sets forth actions that are
335	taken if the clinic closes due to unforeseen disasters. This
336	plan must include provisions for the protection of medical
337	records and any controlled substances.
338	4.  At least one employee who is certified in basic life
339	support and trained in reacting to accidents and medical
340	emergencies must be on the premises of a pain-management clinic
341	during patient-care hours.
342	(l)  Quality assurance.-Each pain-management clinic must
343	have an ongoing quality assurance program that objectively and
344	systematically monitors and evaluates the quality and
345	appropriateness of patient care, evaluates methods to improve
346	patient care, identifies and corrects deficiencies within the
347	facility, alerts the designated physician to identify and
348	resolve recurring problems, and provides for opportunities to
349	improve the facility's performance and to enhance and improve
350	the quality of care provided to the public. The designated
351	physician shall establish a quality assurance program that
352	includes the following components:
353	1.  The identification, investigation, and analysis of the
354	frequency and causes of adverse incidents to patients.
355	2.  The identification of trends or patterns of incidents.
356	3.  The development of measures to correct, reduce,
357	minimize, or eliminate the risk of adverse incidents to
358	patients.
359	4.  The documentation and periodic review of these
360	functions in subparagraphs 1., 2., and 3. at least quarterly by
361	the designated physician.
362
363	A state-licensed risk manager shall review the quality assurance
364	program once every 3 years, provide the Department of Health
365	with documentation of the review and any corrective action plan
366	within 30 days after the review, and maintain the review for
367	inspection purposes.
368	(m)  Data collection and reporting.-
369	1.  The designated physician for each pain-management
370	clinic shall report all adverse incidents to the Department of
371	Health as set forth in s. 458.351, Florida Statutes.
372	2.  The designated physician shall also report to the Board
373	of Medicine each quarter, in writing, the following data:
374	a.  The number of new and repeat patients seen and treated
375	at the pain-management clinic who were prescribed or dispensed
376	controlled substances for the treatment of chronic, nonmalignant
377	pain.
378	b.  The number of patients discharged due to drug abuse.
379	c.  The number of patients discharged due to drug
380	diversion.
381	d.  The number of patients treated at the pain-management
382	clinic whose domicile is located somewhere other than in this
383	state. A patient's domicile is the patient's fixed or permanent
384	home to which the patient intends to return even though he or
385	she may temporarily reside elsewhere.
386	3.  A physician that practices in a pain-management clinic
387	shall advise the Board of Medicine, in writing, within 10
388	calendar days after beginning or ending his or her practice at a
389	pain-management clinic.
390	Section 2.  Paragraph (c) of subsection (1) and subsections
391	(3) and (4) of section 458.3265, Florida Statutes, are amended
392	to read:
393	458.3265  Pain-management clinics.-
394	(1)  REGISTRATION.-
395	(c)1.  As a part of registration, a clinic must designate a
396	physician who is responsible for complying with all requirements
397	related to registration and operation of the clinic in
398	compliance with this section. It is the designated physician's
399	responsibility to ensure that the clinic is registered,
400	regardless of whether other physicians are practicing in the
401	same office or whether the office is not owned by a physician.
402	Within 10 days after termination of a designated physician, the
403	clinic must notify the department of the identity of another
404	designated physician for that clinic or of any changes to the
405	registration information. The designated physician shall have a
406	full, active, and unencumbered license under this chapter or
407	chapter 459 and shall practice at the clinic location for which
408	the physician has assumed responsibility. Failing to have a
409	licensed designated physician practicing at the location of the
410	registered clinic may be the basis for a summary suspension of
411	the clinic registration certificate as described in s.
412	456.073(8) for a license or s. 120.60(6).
413	2.  In order to register a pain-management clinic, the
414	designated physician shall:
415	a.  Pay an inspection fee of $1,500 for each location
416	required to be inspected;
417	b.  Pay a registration fee of $145. The fee must also be
418	paid if the physical location of the clinic changes or the
419	ownership changes. An additional fee of $5 shall be added to the
420	cost of registration to cover unlicensed activity as required by
421	s. 456.065(3); and
422	c.  Provide documentation to support compliance with
423	section 1 of this act.
424	3.  The designated physician shall post the documentation
425	of registration in a conspicuous place in the waiting room which
426	is viewable by the public.
427	(3)  INSPECTION.-
428	(a)  The department shall inspect the pain-management
429	clinic annually, including a review of the patient records, to
430	ensure that it complies with this section and the rules of the
431	Board of Medicine adopted pursuant to subsection (4) unless the
432	clinic is accredited by a nationally recognized accrediting
433	agency approved by the Board of Medicine. Each nationally
434	recognized accrediting agency shall be held to the same board-
435	determined practice standards for registering pain-management
436	clinic in this state.
437	(b)  The department shall conduct unannounced annual
438	inspections of clinics pursuant to this subsection. During an
439	onsite inspection, the department shall make a reasonable
440	attempt to discuss each violation with the owner or designated
441	physician of the pain-management clinic before issuing a formal
442	written notification.
443	(c)  The designated physician shall cooperate with the
444	inspector, make medical records available to the inspector, and
445	be responsive to all reasonable requests. Any action taken to
446	correct a violation shall be documented in writing by the owner
447	or designated physician of the pain-management clinic and
448	verified by followup visits by departmental personnel.
449	(d)  The inspector shall determine compliance with the
450	requirements of section 1 of this act. These requirements
451	include a review of a random selection of patient records for
452	patients who are treated for pain. The inspector shall select
453	such patient records from each physician practicing in the
454	clinic or who has practiced in the clinic during the past 6
455	months.
456	(e)  If the clinic is determined to be in noncompliance,
457	the inspector shall notify the designated physician and give the
458	designated physician a written statement at the time of
459	inspection. Such written notice shall specify the deficiencies
460	in the inspection. Unless the deficiencies constitute an
461	immediate and imminent danger to the public, the designated
462	physician shall be given 30 days after the date of inspection to
463	correct any documented deficiencies and notify the department of
464	a corrective action plan. Upon written notification from the
465	designated physician that all deficiencies have been corrected,
466	the department may reinspect for compliance. If the designated
467	physician fails to submit a corrective action plan within 30
468	days after the inspection, the department may reinspect the
469	clinic to ensure that the deficiencies have been corrected.
470	(f)  The inspector shall forward to the department the
471	written results of the inspection, deficiency notice, and any
472	subsequent documentation, including, but not limited to:
473	1.  Whether the deficiencies constituted an immediate and
474	serious danger to the public;
475	2.  Whether the designated physician provided the
476	department with documentation of correction of all deficiencies
477	within 30 days after the date of inspection; and
478	3.  The results of any reinspection.
479	(g)  The department shall review the results of the
480	inspection and determine whether action against the clinic's
481	registration is merited.
482	(h)  The department's authority is not limited with regard
483	to investigating a complaint without prior notice.
484	(i)  If the clinic is accredited by a nationally recognized
485	accrediting agency that is approved by the board, the designated
486	physician shall submit written notification of the current
487	accreditation survey of his or her clinic in lieu of undergoing
488	an inspection by the department.
489	(j)  The designated physician shall submit, within 30 days
490	after accreditation, a copy of the current accreditation survey
491	of the clinic and shall immediately notify the board of any
492	accreditation changes that occur. For purposes of initial
493	registration, the designated physician shall submit a copy of
494	the most recent accreditation survey of the clinic in lieu of
495	undergoing an inspection by the department.
496	(k)  If a provisional or conditional accreditation is
497	received, the designated physician shall notify the board in
498	writing and include a plan of correction.
499	(4)  RULEMAKING.-
500	(a)  The department shall adopt rules necessary to
501	administer the registration and inspection of pain-management
502	clinics which establish the specific requirements, procedures,
503	forms, and fees.
504	(a)(b)  The department shall adopt a rule defining what
505	constitutes practice by a designated physician at the clinic
506	location for which the physician has assumed responsibility, as
507	set forth in subsection (1). When adopting the rule, the
508	department shall consider the number of clinic employees, the
509	location of the pain-management clinic, the clinic's hours of
510	operation, and the amount of controlled substances being
511	prescribed, dispensed, or administered at the pain-management
512	clinic.
513	(b)(c)  The Board of Medicine shall adopt a rule
514	establishing the maximum number of prescriptions for Schedule II
515	or Schedule III controlled substances or the controlled
516	substance Alprazolam which may be written at any one registered
517	pain-management clinic during any 24-hour period.
518	(d)  The Board of Medicine shall adopt rules setting forth
519	standards of practice for physicians practicing in privately
520	owned pain-management clinics that primarily engage in the
521	treatment of pain by prescribing or dispensing controlled
522	substance medications. Such rules shall address, but need not be
523	limited to:
524	1.  Facility operations;
525	2.  Physical operations;
526	3.  Infection control requirements;
527	4.  Health and safety requirements;
528	5.  Quality assurance requirements;
529	6.  Patient records;
530	7.  Training requirements for all facility health care
531	practitioners who are not regulated by another board;
532	8.  Inspections; and
533	9.  Data collection and reporting requirements.
534
535	A physician is primarily engaged in the treatment of pain by
536	prescribing or dispensing controlled substance medications when
537	the majority of the patients seen are prescribed or dispensed
538	controlled substance medications for the treatment of chronic
539	nonmalignant pain. Chronic nonmalignant pain is pain unrelated
540	to cancer which persists beyond the usual course of the disease
541	or the injury that is the cause of the pain or more than 90 days
542	after surgery.
543	Section 3.  Paragraph (c) of subsection (1) and subsections
544	(3) and (4) of section 459.0137, Florida Statutes, are amended
545	to read:
546	459.0137  Pain-management clinics.-
547	(1)  REGISTRATION.-
548	(c)1.  As a part of registration, a clinic must designate
549	an osteopathic physician who is responsible for complying with
550	all requirements related to registration and operation of the
551	clinic in compliance with this section. It is the designated
552	osteopathic physician's responsibility to ensure that the clinic
553	is registered, regardless of whether other physicians are
554	practicing in the same office or whether the office is not owned
555	by a physician. Within 10 days after termination of a designated
556	osteopathic physician, the clinic must notify the department of
557	the identity of another designated physician for that clinic of
558	any changes to the registration information. The designated
559	physician shall have a full, active, and unencumbered license
560	under chapter 458 or this chapter and shall practice at the
561	clinic location for which the physician has assumed
562	responsibility. Failing to have a licensed designated
563	osteopathic physician practicing at the location of the
564	registered clinic may be the basis for a summary suspension of
565	the clinic registration certificate as described in s.
566	456.073(8) for a license or s. 120.60(6).
567	2.  In order to register a clinic, the designated
568	osteopathic physician shall:
569	a.  Pay an inspection fee of $1,500 for each location
570	required to be inspected;
571	b.  Pay a registration fee of $145. The fee must also be
572	paid if the physical location of the clinic changes or the
573	ownership changes. An additional fee of $5 shall be added to the
574	cost of registration to cover unlicensed activity as required by
575	s. 456.065(3); and
576	c.  Provide documentation to support compliance with
577	section 1 of this act.
578	3.  The designated osteopathic physician shall post the
579	documentation of registration in a conspicuous place in the
580	waiting room which is viewable by the public.
581	(3)  INSPECTION.-
582	(a)  The department shall inspect the pain-management
583	clinic annually, including a review of the patient records, to
584	ensure that it complies with this section and the rules of the
585	Board of Osteopathic Medicine adopted pursuant to subsection (4)
586	unless the clinic is accredited by a nationally recognized
587	accrediting agency approved by the Board of Osteopathic
588	Medicine. Each nationally recognized accrediting agency shall be
589	held to the same board-determined practice standards for
590	registering a clinic in this state.
591	(b)  The department shall conduct unannounced annual
592	inspections of clinics pursuant to this subsection. During an
593	onsite inspection, the department shall make a reasonable
594	attempt to discuss each violation with the owner or designated
595	physician of the pain-management clinic before issuing a formal
596	written notification.
597	(c)  The designated osteopathic physician shall cooperate
598	with the inspector, make medical records available to the
599	inspector, and be responsive to all reasonable requests. Any
600	action taken to correct a violation shall be documented in
601	writing by the owner or designated physician of the pain-
602	management clinic and verified by followup visits by
603	departmental personnel.
604	(d)  The inspector shall determine compliance with the
605	requirements of section 1 of this act. These requirements
606	include a review of a random selection of patient records for
607	patients who are treated for pain. The inspector shall select
608	such patient records from each osteopathic physician practicing
609	in the clinic or who has practiced in the clinic during the past
610	6 months.
611	(e)  If the clinic is determined to be in noncompliance,
612	the inspector shall notify the designated osteopathic physician
613	and give the designated osteopathic physician a written
614	statement at the time of inspection. Such written notice shall
615	specify the deficiencies. Unless the deficiencies constitute an
616	immediate and imminent danger to the public, the designated
617	osteopathic physician shall be given 30 days after the date of
618	inspection to correct any documented deficiencies and notify the
619	department of corrective action plan. Upon written notification
620	from the designated osteopathic physician that all deficiencies
621	have been corrected, the department may reinspect for
622	compliance. If the designated osteopathic physician fails to
623	submit a corrective action plan within 30 days after the
624	inspection, the department may reinspect the office to ensure
625	that the deficiencies have been corrected.
626	(f)  The inspector shall forward to the department the
627	written results of the inspection, deficiency notice and any
628	subsequent documentation, including, but not limited to:
629	1.  Whether the deficiencies constituted an immediate and
630	serious danger to the public;
631	2.  Whether the designated osteopathic physician provided
632	the department with documentation of correction of all
633	deficiencies within 30 days after the date of inspection; and
634	3.  The results of any reinspection.
635	(g)  The department shall review the results of the
636	inspection and determine whether action against the clinic's
637	registration is merited.
638	(h)  The department's authority is not limited with regard
639	to investigating a complaint without prior notice.
640	(i)  If the clinic is accredited by a nationally recognized
641	accrediting agency approved by the board, the designated
642	osteopathic physician shall submit written notification of the
643	current accreditation survey of his or her clinic in lieu of
644	undergoing an inspection by the department.
645	(j)  The designated osteopathic physician shall submit,
646	within 30 days after accreditation, a copy of the current
647	accreditation survey of the clinic and shall immediately notify
648	the board of any accreditation changes that occur. For purposes
649	of initial registration, the designated osteopathic physician
650	shall submit a copy of the most recent accreditation survey of
651	the clinic in lieu of undergoing an inspection by the
652	department.
653	(k)  If a provisional or conditional accreditation is
654	received, the designated osteopathic physician shall notify the
655	board in writing and shall include a plan of correction.
656	(4)  RULEMAKING.-
657	(a)  The department shall adopt rules necessary to
658	administer the registration and inspection of pain-management
659	clinics which establish the specific requirements, procedures,
660	forms, and fees.
661	(a)(b)  The department shall adopt a rule defining what
662	constitutes practice by a designated osteopathic physician at
663	the clinic location for which the physician has assumed
664	responsibility, as set forth in subsection (1). When adopting
665	the rule, the department shall consider the number of clinic
666	employees, the location of the pain-management clinic, the
667	clinic's hours of operation, and the amount of controlled
668	substances being prescribed, dispensed, or administered at the
669	pain-management clinic.
670	(b)(c)  The Board of Osteopathic Medicine shall adopt a
671	rule establishing the maximum number of prescriptions for
672	Schedule II or Schedule III controlled substances or the
673	controlled substance Alprazolam which may be written at any one
674	registered pain-management clinic during any 24-hour period.
675	(d)  The Board of Osteopathic Medicine shall adopt rules
676	setting forth standards of practice for osteopathic physicians
677	practicing in privately owned pain-management clinics that
678	primarily engage in the treatment of pain by prescribing or
679	dispensing controlled substance medications. Such rules shall
680	address, but need not be limited to:
681	1.  Facility operations;
682	2.  Physical operations;
683	3.  Infection control requirements;
684	4.  Health and safety requirements;
685	5.  Quality assurance requirements;
686	6.  Patient records;
687	7.  Training requirements for all facility health care
688	practitioners who are not regulated by another board;
689	8.  Inspections; and
690	9.  Data collection and reporting requirements.
691
692	An osteopathic physician is primarily engaged in the treatment
693	of pain by prescribing or dispensing controlled substance
694	medications when the majority of the patients seen are
695	prescribed or dispensed controlled substance medications for the
696	treatment of chronic nonmalignant pain. Chronic nonmalignant
697	pain is pain unrelated to cancer which persists beyond the usual
698	course of the disease or the injury that is the cause of the
699	pain or more than 90 days after surgery.
700	Section 4.  This act shall take effect July 1, 2011.

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