Florida Senate - 2009 CS for SB 462
By the Committee on Health Regulation; and Senator Fasano
588-02377-09 2009462c1
1 A bill to be entitled
2 An act relating to a prescription drug validation
3 program; creating s. 893.055, F.S.; providing
4 definitions; requiring the Department of Health to
5 establish a comprehensive electronic system to
6 validate the prescribing and dispensing of certain
7 controlled substances; requiring specified prescribing
8 and dispensing information to be reported to the
9 electronic system; requiring the department, in
10 conjunction with specified organizations, to adopt by
11 rule a reasonable-person standard appropriate for the
12 prescription drug validation program; providing a
13 reporting period; providing for implementation of a
14 shorter reporting period; providing exemptions from
15 participation in the system; authorizing the
16 Department of Health to establish when to suspend and
17 when to resume requirements for reporting dispensing
18 information during declared emergencies; requiring all
19 nonexempt pharmacists, pharmacies, dispensing
20 physicians, and prescribing and dispensing health care
21 practitioners to submit information in a specified
22 format; providing that the cost to the dispenser in
23 submitting the required information may not be
24 material or extraordinary; providing that specified
25 costs are not material or extraordinary; limiting
26 access to the system; providing for the use of data
27 for specified purposes; requiring compliance with
28 state and federal privacy and security laws;
29 authorizing an agency or person to maintain the data
30 for a specified period if the data is pertinent to an
31 ongoing health care or active law enforcement
32 investigation or prosecution; requiring the reporting
33 of certain performance measures; providing criminal
34 penalties for violations; requiring that all costs
35 incurred by the department for the program be paid
36 through a federal grant or through available private
37 funding sources; authorizing the Office of Drug
38 Control, in coordination with the Department of
39 Health, to establish a direct-support organization;
40 providing a definition; providing for a board of
41 directors appointed by the director of the Office of
42 Drug Control; authorizing the direct-support
43 organization to operate under written contract with
44 the Office of Drug Control; authorizing certain
45 activities and expenditures of the direct-support
46 organization; providing requirements for the use of
47 certain facilities and services; providing for audits;
48 prohibiting the direct-support organization from
49 exercising certain powers; establishing that a
50 prescribing health care practitioner, dispensing
51 physician, or pharmacist is not liable for use of the
52 department-provided controlled substances prescription
53 information of a patient; requiring a study of the
54 feasibility of enhancing the prescription drug
55 validation program for specified purposes; requiring
56 certain persons to present specified identification to
57 obtain prescriptions; providing for recordkeeping for
58 certain transactions; requiring the Agency for Health
59 Care Administration to continue implementation of
60 electronic prescribing and an electronic prescribing
61 clearinghouse; requiring the Department of Health to
62 adopt rules; establishing a Program Implementation and
63 Oversight Workgroup; providing for membership;
64 providing for reimbursement of certain member
65 expenses; providing for meetings; providing the
66 purpose of the workgroup; requiring reports; providing
67 for the creation, membership, and duties of
68 subcommittees; providing for a final report and the
69 termination of the workgroup; amending s. 458.309,
70 F.S.; requiring certain physicians who engage in pain
71 management to register their facility with the
72 department; requiring the department to inspect the
73 facility; requiring the Board of Medicine to adopt
74 rules setting forth standards of practice for certain
75 physicians who engage in pain management; providing
76 criteria for the rules; providing an effective date.
77
78 WHEREAS, as has been advocated by numerous pain management
79 experts, addiction medicine experts, pharmacists, and law
80 enforcement personnel, a prescription drug validation program
81 that provides for reporting and advisory information is
82 established pursuant to this act to serve as a means to promote
83 the public health and welfare and to detect and prevent
84 controlled substance abuse and diversion, and
85 WHEREAS, while the importance and necessity of the proper
86 prescribing, dispensing, and monitoring of controlled
87 substances, particularly pain medication, have been established,
88 controlled prescription drugs are too often diverted in this
89 state, often through fraudulent means, including outright theft,
90 phony pharmacy fronts, loose Internet medical evaluations, and
91 inappropriate importation; in addition, there is a criminal
92 element that facilitates the prescription drug abuse epidemic
93 through illegal profitmaking from the diversion of certain
94 controlled substances that are prescribed or dispensed by
95 physicians, health care practitioners, and pharmacists, and
96 WHEREAS, in 2007, 8,620 drug-related deaths occurred in
97 this state, 3,159 of which were caused by prescription drugs, an
98 average of nearly 9 Floridians dying each day from prescription
99 drugs; Schedule IV benzodiazepines, such as Xanax and Valium,
100 were found to be present in more drug-related deaths than
101 cocaine; and opiate pain medications contribute to increasing
102 numbers of drug-related deaths, and
103 WHEREAS, pharmaceutical drug diversion hurts this state
104 significantly in terms of lost lives, increased crime, human
105 misery from addiction, and ballooning health care costs
106 connected to treatment, medical expenses, and Medicaid fraud
107 that all Floridians ultimately bear, and
108 WHEREAS, the intent of this act is not to interfere with
109 the legitimate medical use of controlled substances; however,
110 the people of this state are in need of and will benefit from a
111 secure and privacy-protected statewide electronic system of
112 specified prescription drug medication information created
113 primarily to encourage safer controlled substance prescription
114 decisions that reduce the number of prescription drug overdoses
115 and the number of drug overdose deaths; to educate and inform
116 health care practitioners and provide an added tool in patient
117 care, including appropriate treatment for patients who have
118 become addicted; to guide public health initiatives to educate
119 the population on the dangers of misusing prescription drugs; to
120 prevent the abuse or diversion of prescribed controlled
121 substances; and to ensure that those who need prescribed
122 controlled substances receive them in a manner that protects
123 patient confidentiality, and
124 WHEREAS, while certain medicines are very helpful if
125 properly prescribed to a patient in need and then used as
126 prescribed, they may be dangerous or even deadly if improperly
127 dispensed, misused, or diverted, and
128 WHEREAS, it is the intent of the Legislature to encourage
129 patient safety, responsible pain management, and proper access
130 to useful prescription drugs that are prescribed by a
131 knowledgeable, properly licensed health care practitioner who
132 dispenses prescription drugs and that are dispensed by a
133 pharmacist who is made aware of the patient’s prescription drug
134 medication history, thus preventing, in some cases, an abuse or
135 addiction problem from developing or worsening, making such a
136 problem possible or easier to identify, and facilitating the
137 order of appropriate medical treatment or referral, and
138 WHEREAS, such an electronic system will also aid
139 administrative and law enforcement agencies in an active and
140 ongoing controlled drug-related investigation, maintaining such
141 information for any such investigation with a reasonable, good
142 faith anticipation of securing an arrest or prosecution in the
143 foreseeable future, and
144 WHEREAS, a Program Implementation and Oversight Workgroup
145 will provide information to the Governor and Legislature
146 regarding the implementation of the program and ensure that
147 privacy and confidentiality of the patient’s prescription
148 history is respected, NOW, THEREFORE,
149
150 Be It Enacted by the Legislature of the State of Florida:
151
152 Section 1. Section 893.055, Florida Statutes, is created to
153 read:
154 893.055 Prescription drug validation program.—
155 (1) As used in this section, the term:
156 (a) “Advisory report” means information provided by the
157 department in writing to a prescriber, dispenser, pharmacy, or
158 patient concerning the dispensing of controlled substances. All
159 advisory reports are for informational purposes only and impose
160 no obligations of any nature or any legal duty on a prescriber,
161 dispenser, pharmacy, or patient. The advisory reports issued by
162 the department are not subject to discovery or introduction into
163 evidence in any civil or administrative action against a
164 prescriber, dispenser, pharmacy, or patient arising out of the
165 matters that are the subject of the report, and no person who
166 participates in preparing an advisory report is permitted or
167 required to testify in any such civil action as to any findings,
168 recommendations, evaluations, opinions, or other actions taken
169 in connection with preparing such a report.
170 (b) “Controlled substance” means a controlled substance
171 listed in Schedule II, Schedule III, or Schedule IV in s.
172 893.03.
173 (c) “Department” means the Department of Health.
174 (d) “Dispenser” means a dispensing pharmacist or dispensing
175 health care practitioner.
176 (e) “Health care practitioner” or “practitioner” means any
177 practitioner subject to licensure or regulation by the
178 department under chapter 458, chapter 459, chapter 461, or
179 chapter 466.
180 (f) “Health care regulatory board” means any board that
181 licenses a practitioner or health care practitioner who is
182 regulated by the department.
183 (g) “Pharmacy” means any pharmacy subject to licensure or
184 regulation by the department under chapter 465 which dispenses
185 or delivers a controlled substance to a patient in this state.
186 (h) “Prescriber” means a prescribing physician, prescribing
187 practitioner, or other prescribing health care practitioner.
188 (2)(a) By December 1, 2010, the department shall design and
189 establish a comprehensive electronic system that has controlled
190 substance prescriptions provided to it and that provides
191 prescription information to a patient’s health care practitioner
192 and, as determined by the department, may provide advisory
193 reports to authorized pharmacists, pharmacies, prescribing
194 practitioners, and dispensing health care practitioners. The
195 system shall be designed to provide information regarding
196 dispensed prescriptions of controlled substances in order to
197 prevent the inadvertent, improper, or illegal use of controlled
198 substances and shall not infringe upon the legitimate
199 prescribing of a controlled substance by a prescribing
200 practitioner, dispensing pharmacist, or dispensing practitioner
201 acting in good faith and in the course of professional practice.
202 The system shall be consistent with standards of the American
203 Society for Automation in Pharmacy for the validation of
204 prescribing and dispensing controlled substances to an
205 individual. The electronic system shall also comply with the
206 Health Insurance Portability and Accountability Act (HIPAA) as
207 it pertains to protected health information (PHI), electronic
208 protected health information (EPHI), and all other relevant
209 state and federal privacy and security laws and regulations. The
210 validating of prescribed controlled substances shall include a
211 dispensing transaction with a dispenser not located in this
212 state but which is otherwise subject to the jurisdiction of this
213 state as to that dispensing transaction.
214 (b) The department shall adopt rules concerning the
215 reporting, evaluation, management, and storage of information
216 within the system, including rules for when information is
217 provided to pharmacies, prescribers, health care practitioners,
218 health care regulatory boards, and law enforcement agencies, and
219 such rules shall be developed with a reasonable-person standard
220 for prescription drug dispensers, prescribers, and patients. The
221 department shall work with the professional health care
222 licensure boards, such as the Board of Medicine and the Board of
223 Pharmacy and other appropriate organizations, such as the
224 Florida Pharmacy Association and the Florida Medical
225 Association, including those relating to pain management, the
226 the Attorney General, the Department of Law Enforcement, and the
227 Agency for Health Care Administration, to develop the
228 reasonable-person standard for rules appropriate for the
229 prescription drug validation program.
230 (c) All dispensers and prescribers subject to such
231 reporting requirements shall be notified by the department of
232 the implementation date for such reporting requirements.
233 (3) The pharmacist in charge of each pharmacy, regarding
234 each controlled substance dispensed by a pharmacist under the
235 supervision of the pharmacist in charge, and each prescriber who
236 directly dispenses a controlled substance shall submit to the
237 electronic system, by a procedure and in a format established by
238 the department, the following minimum information for inclusion
239 in the database:
240 (a) The name of the prescribing practitioner and the
241 practitioner’s federal Drug Enforcement Administration
242 registration number, the practitioner’s National Provider
243 Identification (NPI) or other appropriate identifier, and the
244 date of the prescription.
245 (b) The date the prescription was filled and the method of
246 payment therefor, including cash. This paragraph does not
247 authorize the department to include individual credit card or
248 other account numbers in the database.
249 (c) The name, address, and date of birth of the person for
250 whom the prescription was written.
251 (d) The name, national drug code, quantity, and strength of
252 the controlled substance dispensed.
253 (e) The name and address of the pharmacy or other location
254 from which the controlled substance was dispensed.
255 (f) The name of the pharmacist or practitioner dispensing
256 the controlled substance, the practitioner’s National Provider
257 Identification (NPI), and other appropriate identifying
258 information as determined by department rule.
259 (4) Each time a controlled substance is dispensed to an
260 individual, the controlled substance shall be reported to the
261 department through the system as soon thereafter as possible,
262 but not more than 15 days after the date the controlled
263 substance is dispensed. A dispenser must meet the reporting
264 requirements of this section by providing the required
265 information concerning each controlled substance that it
266 dispensed in a department-approved, secure methodology and
267 format. Such approved formats may include, but are not limited
268 to, submission via the Internet, on a disc, or by use of regular
269 mail.
270 (5) The following are exempt from this section when
271 administering controlled substances:
272 (a) A health care practitioner administering a controlled
273 substance directly to a patient if the amount of the controlled
274 substance is adequate to treat the patient during that
275 particular treatment session.
276 (b) A pharmacist or health care practitioner administering
277 a controlled substance to a patient or resident receiving care
278 as an admitted patient at a hospital, nursing home, hospice, or
279 intermediate care facility for the developmentally disabled
280 which is licensed in this state.
281 (c) A person administering a controlled substance in the
282 health care system of the Department of Corrections.
283 (d) A person administering a controlled substance in the
284 emergency room of a licensed hospital.
285 (e) A pharmacist or health care practitioner administering
286 a controlled substance to a person under the age of 16.
287 (6) The department may establish when to suspend and when
288 to resume requirements for reporting dispensing information to
289 the electronic system of controlled prescription drugs during a
290 state-declared or nationally declared disaster.
291 (7)(a) A practitioner or pharmacist who dispenses a
292 controlled substance must submit the information required by
293 this section in an electronic or other format approved by rule
294 of the department. The cost to the dispenser in submitting the
295 information required by this section may not be material or
296 extraordinary. Costs not considered to be material or
297 extraordinary include, but are not limited to, regular postage,
298 electronic media, regular electronic mail, and facsimile
299 charges.
300 (b) A pharmacy, prescriber, or dispenser may access
301 information in the prescription drug validation program’s
302 electronic system which relates to a patient of that pharmacy,
303 prescriber, or dispenser for the purpose of reviewing the
304 patient’s controlled drug prescription history to ensure a
305 proper standard of care. Other access to the program’s
306 electronic system shall be limited to the program’s manager and
307 designated program staff, who may act only in the absence of the
308 program manager. Access by the program manager or such
309 designated staff is only for prescription drug management and
310 for management of the database. Confidential and exempt
311 information in the database shall be released only as provided
312 in s. 893.0551. The individual who requests his or her own
313 information, the attorney general, a health care regulatory
314 board, any law enforcement agency, or any criminal justice
315 agency may request this information from the program manager and
316 may not directly access the database for this information.
317 (c) All transmissions of data required by this section must
318 comply with relevant state and federal privacy and security laws
319 and regulations. However, any authorized agency or person
320 receiving such information may maintain the information received
321 for up to 24 months before purging it from his or her records or
322 maintain it for longer than 24 months if the information is
323 pertinent to an ongoing health care or active law enforcement
324 investigation or prosecution.
325 (8) To assist in fulfilling the program responsibilities,
326 performance measures shall be reported annually by the
327 department each December 1, beginning in 2011. Data that does
328 not contain patient, physician, health care practitioner, or
329 dispenser identifying information may be requested during the
330 year by department employees so that the department may
331 undertake public health care and safety initiatives that take
332 advantage of observed trends. Performance measures may include,
333 but are not limited to, efforts to achieve the following
334 outcomes:
335 (a) Reduction of the rate of inappropriate use of
336 prescription drugs through department education and safety
337 efforts.
338 (b) Reduction of the quantity of pharmaceutical controlled
339 substances obtained by individuals attempting to engage in fraud
340 and deceit.
341 (c) Increased coordination among prescription drug
342 validation program partners.
343 (d) Involvement of stakeholders in achieving improved
344 patient health care and reduction of prescription drug abuse and
345 prescription drug diversion.
346 (9) Any person who knowingly fails to report the dispensing
347 of a controlled substance as required by this section commits a
348 misdemeanor of the first degree, punishable as provided in s.
349 775.082 or s. 775.083.
350 (10) All costs incurred by the department in administering
351 the prescription drug validation program shall be reimbursed
352 through federal grants or private funding applied for or
353 received by the state. The department and state government shall
354 cooperate in seeking federal grant funds, other nonstate grant
355 funds, gifts, donations, or other private moneys for the
356 department so long as the costs of doing so are not considered
357 material. Nonmaterial costs for this purpose include, but are
358 not limited to, the costs of mailing and personnel assigned to
359 research or apply for a grant. Notwithstanding the exemptions to
360 competitive-solicitation requirements under s. 287.057(5)(f),
361 the Department of Health shall comply with the competitive
362 solicitation requirements for the procurement of any goods or
363 services required by this section.
364 (11) The Office of Drug Control, in coordination with the
365 department, may establish a direct-support organization that has
366 a board consisting of at least five members to provide
367 assistance, funding, and promotional support for the activities
368 authorized for the prescription drug validation program.
369 (a) As used in this subsection, the term “direct-support
370 organization” means an organization that is:
371 1. A Florida corporation not for profit incorporated under
372 chapter 617, exempted from filing fees, and approved by the
373 Department of State.
374 2. Organized and operated to conduct programs and
375 activities; raise funds; request and receive grants, gifts, and
376 bequests of money; acquire, receive, hold, and invest, in its
377 own name, securities, funds, objects of value, or other
378 property, either real or personal; and make expenditures to or
379 for the direct or indirect benefit of the department in the
380 furtherance of the prescription drug validation program.
381 (b) The direct-support organization is not considered a
382 lobbying firm within the meaning of s. 11.045.
383 (c) The director of the Office of Drug Control shall
384 appoint a board of directors for the direct-support
385 organization. The director may designate employees of the Office
386 of Drug Control; state employees other than state employees from
387 the Department of Health; members of provider associations, such
388 as the Florida Pharmacy Association or the Florida Medical
389 Association; and any other nonstate employees as appropriate, to
390 serve on such board. Members of the board shall serve at the
391 pleasure of the director of the Office of Drug Control.
392 (d) The direct-support organization may operate under
393 written contract with the Office of Drug Control. The contract
394 must provide for:
395 1. Approval of the articles of incorporation and bylaws of
396 the direct-support organization by the Office of Drug Control.
397 2. Submission of an annual budget for the approval of the
398 Office of Drug Control.
399 3. Certification by the Office of Drug Control in
400 consultation with the department that the direct-support
401 organization is complying with the terms of the contract in a
402 manner consistent with and in furtherance of the goals and
403 purposes of the prescription drug validation program and in the
404 best interest of the state. Such certification must be made
405 annually and reported in the official minutes of a meeting of
406 the direct-support organization.
407 4. The reversion, without penalty, to the Office of Drug
408 Control, or to the state if the Office of Drug Control ceases to
409 exist, of all moneys and property held in trust by the direct
410 support organization for the benefit of the prescription drug
411 validation program if the direct-support organization ceases to
412 exist or if the contract is terminated.
413 5. The fiscal year of the direct-support organization,
414 which must begin July 1 of each year and end June 30 of the
415 following year.
416 6. The disclosure of the material provisions of the
417 contract to donors of gifts, contributions, or bequests,
418 including such disclosure on all promotional and fundraising
419 publications, and an explanation to such donors of the
420 distinction between the Office of Drug Control and the direct
421 support organization.
422 (e) The direct-support organization is specifically
423 authorized to collect and expend funds to be used for the
424 functions of the direct-support organization’s board of
425 directors, as necessary; establishing and administering the
426 prescription drug validation program’s electronic database,
427 including hardware, software, and personnel; conducting studies
428 on the efficiency and effectiveness of the program; providing
429 funds for future enhancements of the program within the intent
430 of this section; providing health care practitioner education,
431 including distribution of materials to promote public awareness
432 and education and conducting workshops or other meetings; travel
433 expenses; administrative costs, including personnel, audits,
434 facilities, and equipment; and all other requirements necessary
435 to establish the program as outlined in this section.
436 (f) The activities of the direct-support organization must
437 be consistent with the goals and mission of the Office of Drug
438 Control, as determined by the office in consultation with the
439 department, and in the best interests of the state. The direct
440 support organization must obtain a written approval from the
441 director of the Office of Drug Control for any activities in
442 support of the prescription drug validation program before
443 undertaking those activities.
444 (g) The Office of Drug Control, in consultation with the
445 department, may permit, without charge, appropriate use of
446 administrative services, property, and facilities of the Office
447 of Drug Control and the department by the direct-support
448 organization, subject to this section. The use must be directly
449 in keeping with the approved purposes of the direct-support
450 organization and may not be made at times or places that would
451 unreasonably interfere with opportunities for the public to use
452 such facilities for established purposes. Any moneys received
453 from rentals of facilities and properties managed by the Office
454 of Drug Control and the department may be held by the Office of
455 Drug Control or in a separate depository account in the name of
456 the direct-support organization and subject to the provisions of
457 the letter of agreement with the Office of Drug Control. The
458 letter of agreement must provide that any funds held in the
459 separate depository account in the name of the direct-support
460 organization must revert to the Office of Drug Control if the
461 direct-support organization is no longer approved by the Office
462 of Drug Control to operate in the best interests of the state.
463 (h) The Office of Drug Control, in consultation with the
464 department, may adopt requirements with which a direct-support
465 organization must comply in order to use department and Office
466 of Drug Control administrative services, property, or
467 facilities.
468 (i) The Office of Drug Control may not permit the use of
469 any administrative services, property, or facilities of the
470 state by a direct-support organization if that organization does
471 not provide equal membership and employment opportunities to all
472 persons regardless of race, color, religion, gender, age, or
473 national origin.
474 (j) The direct-support organization shall provide for an
475 independent annual financial audit in accordance with s.
476 215.981. Copies of the audit shall be provided to the Office of
477 Drug Control and the Office of Policy and Budget in the
478 Executive Office of the Governor.
479 (k) The direct-support organization may not exercise any
480 power under s. 617.0302(12) or (16).
481 (12) A prescriber or dispenser is authorized access to the
482 information under this section for his or her patient for his or
483 her review of the patient’s controlled drug prescription history
484 to ensure a proper standard of care. A prescriber or dispenser
485 acting in good faith is immune from any civil, criminal, or
486 administrative liability that might otherwise be incurred or
487 imposed for receiving or using information from the prescription
488 drug validation program. This subsection does not create a
489 private cause of action, and a person may not recover damages
490 against a prescriber or dispenser authorized to access
491 information under this subsection for accessing or failing to
492 access such information.
493 (13) To the extent that funding is provided for such
494 purpose through federal or private grants or gifts and other
495 types of available moneys, the department, in collaboration with
496 the Office of Drug Control, shall study the feasibility of
497 enhancing the prescription drug validation program for the
498 purposes of public health initiatives and statistical reporting
499 that respects the privacy of the patient, the prescriber, and
500 the dispenser. Such a study shall be conducted in order to
501 further improve the quality of health care services and safety
502 by improving prescription drug prescribing practices, taking
503 advantage of advances in technology, reducing duplicative
504 prescriptions and the overprescribing of prescription drugs, and
505 reducing drug abuse. In addition, the direct-support
506 organization shall provide funding for the department, in
507 collaboration with the Office of Drug Control, to conduct
508 training for health care practitioners and other appropriate
509 persons in using the program to support the program
510 enhancements.
511 (14) A pharmacist, pharmacy, or dispensing health care
512 practitioner or his or her agent, prior to releasing a
513 controlled substance to any person not known to such dispenser,
514 shall require the person purchasing, receiving, or otherwise
515 acquiring the controlled substance to present valid photographic
516 identification or other verification of his or her identity to
517 the dispenser. If the person does not have proper
518 identification, the dispenser may verify the validity of the
519 prescription and the identity of the patient with the prescriber
520 or his or her authorized agent, or by a method determined by the
521 department, before dispensing the controlled substance. The
522 person purchasing, receiving, or otherwise acquiring the
523 controlled substance does not have to be the specific patient to
524 whom the prescription is prescribed. A record shall be
525 maintained for 2 years of the person acquiring the controlled
526 substance, which record shall include the person’s name and
527 signature using the proper identification. This subsection does
528 not apply in an institutional setting or to a long-term care
529 facility, including, but not limited to, an assisted living
530 facility or a hospital to which patients are admitted. As used
531 in this subsection, the term “proper identification” means a
532 government-issued identification containing the person’s
533 picture, printed name, and signature.
534 (15) The Agency for Health Care Administration shall
535 continue the implementation of electronic prescribing by health
536 care practitioners, health care facilities, and pharmacies under
537 s. 408.061 and the electronic prescribing clearinghouse
538 collaboration with the private sector under s. 408.0611.
539 (16) By October 1, 2010, the department shall adopt rules
540 pursuant to ss. 120.536(1) and 120.54 to implement the
541 provisions of this section.
542 Section 2. (1) The Program Implementation and Oversight
543 Workgroup is created within the Executive Office of the
544 Governor. The director of the Office of Drug Control shall be a
545 nonvoting, ex officio member of the workgroup and shall act as
546 chair. The Office of Drug Control and the Department of Health
547 shall provide staff support for the workgroup.
548 (a) The following state officials shall serve on the
549 workgroup:
550 1. The Attorney General or his or her designee.
551 2. The Secretary of Children and Family Services or his or
552 her designee.
553 3. The Secretary of Health Care Administration or his or
554 her designee.
555 4. The State Surgeon General or his or her designee.
556 (b) In addition, the Governor shall appoint 10 members of
557 the public to serve on the workgroup. Of these 10 appointed
558 members, one member must have professional or occupational
559 expertise in computer security; one member must be a Florida
560 licensed, board-certified oncologist; two members must be
561 Florida-licensed, board-certified, fellowship-trained physicians
562 who have experience in pain management; one member must have
563 professional or occupational expertise in e-Prescribing or
564 prescription drug validation programs; one member must be a
565 Florida-licensed pharmacist; one member must have professional
566 or occupational expertise in law enforcement with experience in
567 prescription drug investigations; one member must have
568 professional or occupational expertise as an epidemiologist with
569 a background in tracking and analyzing drug trends; and two
570 members must have professional or occupational expertise as
571 providers of substance abuse treatment, with priority given to a
572 member who is a former substance abuser.
573 (c) Members appointed by the Governor shall be appointed to
574 a term of 3 years each. Any vacancy on the workgroup shall be
575 filled in the same manner as the original appointment, and any
576 member appointed to fill a vacancy shall serve only for the
577 unexpired term of the member’s predecessor.
578 (d) Members of the workgroup and members of subcommittees
579 appointed under subsection (4) shall serve without compensation,
580 but are entitled to reimbursement for per diem and travel
581 expenses as provided in s. 112.061, Florida Statutes.
582 (e) The workgroup shall meet at least quarterly or upon the
583 call of the chair.
584 (2) The purpose of the workgroup is to monitor the
585 implementation and safeguarding of the electronic system
586 established for the prescription drug validation program under
587 s. 893.055, Florida Statutes, and to ensure privacy, protection
588 of individual medication history, and the electronic system’s
589 appropriate use by physicians, dispensers, pharmacies, law
590 enforcement agencies, and those authorized to request
591 information from the electronic system.
592 (3) The Office of Drug Control shall submit a report to the
593 Governor, the President of the Senate, and the Speaker of the
594 House of Representatives by December 1 of each year which
595 contains a summary of the work of the workgroup during that year
596 and the recommendations developed in accordance with the
597 workgroup’s purpose as provided in subsection (2). Interim
598 reports may be submitted at the discretion of the chair.
599 (4) The chair of the workgroup shall appoint subcommittees
600 that include members of state agencies that are not represented
601 on the workgroup for the purpose of soliciting input and
602 recommendations from those state agencies as needed by the
603 workgroup to accomplish its purposes. In addition, the chair may
604 appoint subcommittees as necessary from among the members of the
605 workgroup in order to efficiently address specific issues. If a
606 state agency is to be represented on any subcommittee, the
607 representative shall be the head of the agency or his or her
608 designee. The chair may designate lead and contributing agencies
609 within a subcommittee.
610 (5) The workgroup shall provide a final report in
611 accordance with the workgroup’s purpose as provided in
612 subsection (2) on July 1, 2012, to the Governor, the President
613 of the Senate, and the Speaker of the House of Representatives.
614 Such report shall be prepared using only data that does not
615 identify a patient or dispenser. The workgroup shall expire and
616 this section is repealed on that date.
617 Section 3. Subsections (4) and (5) are added to section
618 458.309, Florida Statutes, to read:
619 458.309 Rulemaking authority.—
620 (4) Each physician who practices in a privately owned pain
621 management facility that primarily engages in the treatment of
622 pain by prescribing narcotic medications shall register the
623 facility with the department unless it is licensed as a facility
624 under chapter 395. The department shall inspect the facility
625 annually to ensure that it complies with board rules adopted
626 pursuant to s. 458.309(4) and (5) unless the facility is
627 accredited by a nationally recognized accrediting agency
628 approved by the board. The actual costs for registration and
629 inspection or accreditation shall be paid by the physician
630 seeking to register the facility.
631 (5) The board shall adopt rules setting forth standards of
632 practice for physicians practicing in privately owned pain
633 management facilities that primarily engage in the treatment of
634 pain by prescribing controlled substance medications. These
635 rules shall address, but need not be limited to, the following
636 subjects:
637 (a) Facility operations;
638 (b) Physical operations;
639 (c) Infection control requirements;
640 (d) Health and safety requirements;
641 (e) Quality assurance requirements;
642 (f) Patient records;
643 (g) Training requirements for all facility health care
644 practitioners; and
645 (h) Inspections.
646
647 A physician is primarily engaged in the treatment of pain by
648 prescribing narcotic medications when the majority of the
649 patients seen on any day the facility is open are issued
650 narcotic prescriptions for the treatment of nonmalignant pain.
651 Section 4. This act shall take effect July 1, 2009.