Florida Senate - 2009 CS for CS for CS for SB 462
By the Committees on Governmental Oversight and Accountability;
Judiciary; and Health Regulation; and Senator Fasano
585-03922-09 2009462c3
1 A bill to be entitled
2 An act relating to prescription drugs; creating s.
3 893.055, F.S.; providing definitions; requiring the
4 Department of Health to establish a comprehensive
5 electronic database system to monitor the prescribing
6 and dispensing of certain controlled substances;
7 requiring specified prescribing and dispensing
8 information to be reported to the electronic database
9 system; requiring the department, in conjunction with
10 specified organizations, to adopt by rule a
11 reasonable-person standard appropriate for the
12 prescription drug monitoring program; providing
13 reporting requirements; providing a reporting period;
14 providing exemptions from participation in the system;
15 authorizing the department to establish when to
16 suspend and when to resume reporting requirements
17 during declared emergencies; requiring all nonexempt,
18 dispensing pharmacists and practitioners to submit
19 information in a specified format; providing that the
20 cost to the dispenser in submitting the required
21 information may not be material or extraordinary;
22 specifying costs that are not material or
23 extraordinary; providing access to information
24 reported to the system under certain circumstances;
25 providing for the use of data for specified purposes;
26 providing requirements for verification of information
27 requested; requiring data transmission to comply 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
31 ongoing health care or an active law enforcement
32 investigation or prosecution; requiring the annual
33 reporting of certain performance measures to the
34 Governor and Legislature; providing performance
35 measure criteria; providing criminal penalties for
36 violations; requiring that all costs incurred by the
37 department for the program be funded through federal
38 grants or available private funding sources; providing
39 requirements for seeking funding and procuring goods
40 or services; authorizing the Office of Drug Control,
41 in coordination with the department, to establish a
42 direct-support organization; providing a definition;
43 providing for a board of directors appointed by the
44 director of the office; requiring the director to
45 provide guidance to the board regarding acceptance of
46 moneys from appropriate sources; requiring the direct
47 support organization to operate under written contract
48 with the office; providing contract requirements;
49 providing requirements for the direct-support
50 organization’s collecting, expending, and providing of
51 funds; requiring department approval of activities of
52 the direct-support organization; authorizing the
53 office to adopt rules for the use of certain
54 facilities and services; providing for audits;
55 prohibiting the direct-support organization from
56 exercising certain powers; establishing that a
57 prescriber or dispenser is not liable for good faith
58 use of the department-provided controlled substance
59 prescription information of a patient; requiring the
60 department, in collaboration with the office, to study
61 the feasibility of enhancing the prescription drug
62 monitoring program for specified purposes to the
63 extent that funding is provided for such purpose;
64 requiring certain persons to present specified
65 identification in order to obtain controlled
66 substances; providing for recordkeeping for certain
67 transactions; requiring the Agency for Health Care
68 Administration to continue implementation of
69 electronic prescribing and an electronic prescribing
70 clearinghouse; requiring the department to adopt
71 rules; establishing a Program Implementation and
72 Oversight Task Force; providing for membership;
73 providing for reimbursement of certain member
74 expenses; providing for meetings; providing the
75 purpose of the task force; requiring reports to the
76 Governor and Legislature; providing for the creation,
77 membership, and duties of subcommittees; providing for
78 a final report and the termination of the task force;
79 amending ss. 458.309 and 459.005, F.S.; requiring
80 certain physicians who engage in pain management to
81 register their clinics with the department; requiring
82 the department to inspect each facility; providing for
83 exceptions; requiring the physician seeking to
84 register the clinic to pay the costs of registration
85 and inspection or accreditation; requiring the Board
86 of Medicine and the Board of Osteopathic Medicine to
87 adopt rules setting forth standards of practice for
88 certain physicians who engage in pain management;
89 providing criteria for the rules; providing an
90 effective date.
91
92 WHEREAS, as has been advocated by numerous pain management
93 experts, addiction medicine experts, pharmacists, and law
94 enforcement personnel, a prescription drug monitoring program
95 that provides for reporting and advisory information and other
96 specified information is established pursuant to this act to
97 serve as a means to promote the public health and welfare and to
98 detect and prevent controlled substance abuse and diversion, and
99 WHEREAS, while the importance and necessity of the proper
100 prescribing, dispensing, and monitoring of controlled
101 substances, particularly pain medication, have been established,
102 controlled prescription drugs are too often diverted in this
103 state, often through fraudulent means, including outright theft,
104 phony pharmacy fronts, loose Internet medical evaluations, and
105 inappropriate importation; in addition, there is a criminal
106 element that facilitates the prescription drug abuse epidemic
107 through illegal profitmaking from the diversion of certain
108 controlled substances that are prescribed or dispensed by
109 physicians, health care practitioners, and pharmacists, and
110 WHEREAS, in 2007, 8,620 drug-related deaths occurred in
111 this state, 3,159 of which were caused by prescription drugs, an
112 average of nearly 9 Floridians dying each day from prescription
113 drugs; Schedule IV benzodiazepines, such as Xanax and Valium,
114 were found to be present in more drug-related deaths than
115 cocaine; and opiate pain medications were found to be
116 contributing to the increasing numbers of drug-related deaths,
117 and
118 WHEREAS, pharmaceutical drug diversion hurts this state
119 significantly in terms of lost lives, increased crime, human
120 misery from addiction, and ballooning health care costs
121 connected to treatment, medical expenses, and Medicaid fraud
122 that all Floridians ultimately bear, and
123 WHEREAS, the intent of this act is not to interfere with
124 the legitimate medical use of controlled substances; however,
125 the people of this state are in need of and will benefit from a
126 secure and privacy-protected statewide electronic system of
127 specified prescription drug medication information created
128 primarily to encourage safer controlled substance prescription
129 decisions that reduce the number of prescription drug overdoses
130 and the number of drug overdose deaths; to educate and inform
131 health care practitioners and provide an added tool in patient
132 care, including appropriate treatment for patients who have
133 become addicted; to guide public health initiatives to educate
134 the population on the dangers of misusing prescription drugs; to
135 prevent the abuse or diversion of prescribed controlled
136 substances; and to ensure that those who need prescribed
137 controlled substances receive them in a manner that protects
138 patient confidentiality, and
139 WHEREAS, while certain medicines are very helpful if
140 properly prescribed to a patient in need and then used as
141 prescribed, they may be dangerous or even deadly if improperly
142 dispensed, misused, or diverted, and
143 WHEREAS, it is the intent of the Legislature to encourage
144 patient safety, responsible pain management, and proper access
145 to useful prescription drugs that are prescribed by a
146 knowledgeable, properly licensed health care practitioner who
147 dispenses prescription drugs and that are dispensed by a
148 pharmacist who is made aware of the patient’s prescription drug
149 medication history, thus preventing, in some cases, an abuse or
150 addiction problem from developing or worsening, making such a
151 problem possible or easier to identify, and facilitating the
152 order of appropriate medical treatment or referral, and
153 WHEREAS, such an electronic system will also aid
154 administrative and law enforcement agencies in an active and
155 ongoing controlled substance-related investigation and will
156 allow decisions and recommendations for pursuing appropriate
157 administrative or criminal actions while maintaining such
158 information for any such investigation with a reasonable, good
159 faith anticipation of securing an arrest or prosecution in the
160 foreseeable future, and
161 WHEREAS, a Program Implementation and Oversight Task Force
162 will provide information to the Governor and Legislature
163 regarding the implementation of the program and ensure that
164 privacy and confidentiality of the patient’s prescription
165 history is respected, NOW, THEREFORE,
166
167 Be It Enacted by the Legislature of the State of Florida:
168
169 Section 1. Section 893.055, Florida Statutes, is created to
170 read:
171 893.055 Prescription drug monitoring program.—
172 (1) As used in this section, the term:
173 (a) “Advisory report” means information provided by the
174 department in writing, or as determined by the department, to a
175 prescriber, dispenser, pharmacy, or patient concerning the
176 dispensing of controlled substances. All advisory reports are
177 for informational purposes only and impose no obligations of any
178 nature or any legal duty on a prescriber, dispenser, pharmacy,
179 or patient. The advisory reports issued by the department are
180 not subject to discovery or introduction into evidence in any
181 civil or administrative action against a prescriber, dispenser,
182 pharmacy, or patient arising out of matters that are the subject
183 of the report, and a person who participates in preparing,
184 reviewing, issuing, or other activity related to an advisory
185 report may not be permitted or required to testify in any such
186 civil action as to any findings, recommendations, evaluations,
187 opinions, or other actions taken in connection with preparing,
188 reviewing, or issuing such a report.
189 (b) “Controlled substance” means a controlled substance
190 listed in Schedule II, Schedule III, or Schedule IV in s.
191 893.03.
192 (c) “Dispenser” means a dispensing pharmacist or dispensing
193 health care practitioner.
194 (d) “Health care practitioner” or “practitioner” means any
195 practitioner who is subject to licensure or regulation by the
196 department under chapter 458, chapter 459, chapter 461, chapter
197 462, chapter 464, chapter 465, or chapter 466.
198 (e) “Health care regulatory board” means any board for a
199 practitioner or health care practitioner who is licensed or
200 regulated by the department.
201 (f) “Pharmacy” means any pharmacy that is subject to
202 licensure or regulation by the department under chapter 465 and
203 that dispenses or delivers a controlled substance to an
204 individual or address in this state.
205 (g) “Prescriber” means a prescribing physician, prescribing
206 practitioner, or other prescribing health care practitioner.
207 (2)(a) By December 1, 2010, the department shall design and
208 establish a comprehensive electronic database system that has
209 controlled substance prescriptions provided to it and that
210 provides prescription information to a patient’s health care
211 practitioner and pharmacist who inform the department that they
212 wish the patient advisory report provided to them. Otherwise,
213 the patient advisory report will not be sent to the
214 practitioner, pharmacy, or pharmacist. The system shall be
215 designed to provide information regarding dispensed
216 prescriptions of controlled substances and shall not infringe
217 upon the legitimate prescribing or dispensing of a controlled
218 substance by a prescriber or dispenser acting in good faith and
219 in the course of professional practice. The system shall be
220 consistent with standards of the American Society for Automation
221 in Pharmacy (ASAP). The electronic system shall also comply with
222 the Health Insurance Portability and Accountability Act (HIPAA)
223 as it pertains to protected health information (PHI), electronic
224 protected health information (EPHI), and all other relevant
225 state and federal privacy and security laws and regulations. The
226 reporting of prescribed controlled substances shall include a
227 dispensing transaction with a dispenser pursuant to chapter 465
228 or through a dispensing transaction with a pharmacy that is not
229 located in this state but who is otherwise subject to the
230 jurisdiction of this state as to that dispensing transaction.
231 The reporting of patient advisories only refers to reports to
232 pharmacists and practitioners. Separate reports that have
233 patient prescription history information that are not patient
234 advisory reports are provided to persons and entities as
235 authorized in paragraphs (7)(b) and (c) and s. 893.0551.
236 (b) The department shall adopt rules as necessary
237 concerning the reporting, accessing, evaluation, management,
238 development, implementation, operation, and storage of
239 information within the system, including rules for when patient
240 advisory reports and patient information is provided to
241 pharmacies, prescribers, and health care practitioners and rules
242 for when health care regulatory boards, law enforcement
243 agencies, and other persons or organizations authorized in this
244 section and s. 893.0551 are provided patient prescription
245 history information from the database unless provision of such
246 information is otherwise described in this section. Such rules
247 shall be developed with a reasonable-person standard for
248 controlled prescription drug dispensers, prescribers, and
249 patients. The department shall work with the professional health
250 care licensure boards, such as the Board of Medicine, the Board
251 of Osteopathic Medicine, and the Board of Pharmacy; other
252 appropriate organizations, such as the Florida Pharmacy
253 Association, the Florida Medical Association, and the Florida
254 Osteopathic Medical Association, including those relating to
255 pain management; and the Attorney General, the Department of Law
256 Enforcement, and the Agency for Health Care Administration, to
257 develop the reasonable-person standard for rules appropriate for
258 the prescription drug monitoring program.
259 (c) All dispensers and prescribers subject to these
260 reporting requirements shall be notified by the department of
261 the implementation date for such reporting requirements.
262 (3) The pharmacy dispensing the controlled substance and
263 each prescriber who directly dispenses a controlled substance
264 shall submit to the electronic system, by a procedure and in a
265 format established by the department and consistent with an
266 ASAP-approved format, the following information for inclusion in
267 the database:
268 (a) The name of the prescribing practitioner, the
269 practitioner’s federal Drug Enforcement Administration
270 registration number, the practitioner’s National Provider
271 Identification (NPI) or other appropriate identifier, and the
272 date of the prescription.
273 (b) The date the prescription was filled and the method of
274 payment, such as cash by an individual or insurance through a
275 third party. This paragraph does not authorize the department to
276 include individual credit card or other account numbers in the
277 database.
278 (c) The full name, address, and date of birth of the person
279 for whom the prescription was written.
280 (d) The name, national drug code, quantity, and strength of
281 the controlled substance dispensed.
282 (e) The full name and address of the pharmacy or other
283 location from which the controlled substance was dispensed.
284 (f) The name of the pharmacy or practitioner other than a
285 pharmacist, dispensing the controlled substance and the
286 practitioner’s National Provider Identification (NPI).
287 (g) Other appropriate identifying information as determined
288 by department rule.
289 (4) Each time a controlled substance is dispensed to an
290 individual, the controlled substance shall be reported to the
291 department through the system as soon thereafter as possible,
292 but not more than 15 days after the date the controlled
293 substance is dispensed unless an extension is approved by the
294 department for cause as determined by rule. A dispenser must
295 meet the reporting requirements of this section by providing the
296 required information concerning each controlled substance that
297 it dispensed in a department-approved, secure methodology and
298 format. Such approved formats may include, but are not limited
299 to, submission via the Internet, on a disc, or by use of regular
300 mail.
301 (5) The following are exempt from this section when
302 administering or dispensing a controlled substance:
303 (a) A health care practitioner administering a controlled
304 substance directly to a patient if the amount of the controlled
305 substance is adequate to treat the patient during that
306 particular treatment session.
307 (b) A pharmacist or health care practitioner administering
308 a controlled substance to a patient or resident receiving care
309 as a patient at a hospital, nursing home, ambulatory surgical
310 center, hospice, or intermediate care facility for the
311 developmentally disabled which is licensed in this state.
312 (c) A practitioner administering a controlled substance in
313 the health care system of the Department of Corrections.
314 (d) A practitioner administering a controlled substance in
315 the emergency room of a licensed hospital.
316 (e) A health care practitioner administering or dispensing
317 a controlled substance to a person under the age of 16.
318 (f) A pharmacist or a dispensing practitioner dispensing a
319 one-time, 72-hour emergency resupply of a controlled substance
320 to a patient.
321 (6) The department may establish when to suspend and when
322 to resume reporting information during a state-declared or
323 nationally declared disaster.
324 (7)(a) A practitioner or pharmacist who dispenses a
325 controlled substance must submit the information required by
326 this section in an electronic or other method in an ASAP format
327 approved by rule of the department unless otherwise provided in
328 this section. The cost to the dispenser in submitting the
329 information required by this section may not be material or
330 extraordinary. Costs not considered to be material or
331 extraordinary include, but are not limited to, regular postage,
332 electronic media, regular electronic mail, and facsimile
333 charges.
334 (b) A pharmacy, prescriber, or dispenser shall have direct
335 access to information in the prescription drug monitoring
336 program’s database which relates to a patient of that pharmacy,
337 prescriber, or dispenser in a manner established by the
338 department as needed for the purpose of reviewing the patient’s
339 controlled substance prescription history. Other access to the
340 program’s database shall be limited to the program’s manager and
341 to the designated program and support staff, who may act only at
342 the direction of the program manager or in the absence of the
343 program manager. Access by the program manager or such
344 designated staff is for prescription drug program management
345 only or for management of the program’s database and its system
346 in support of the requirements of this section and in
347 furtherance of the prescription drug monitoring program.
348 Confidential and exempt information in the database shall be
349 released only as provided in paragraph (c) and s. 893.0551.
350 (c) The following entities shall not be allowed direct
351 access to information in the prescription drug monitoring
352 program database but may request from the program manager and,
353 when authorized by the program manager, the program manager’s
354 program and support staff, information that is confidential and
355 exempt under s. 893.0551. Prior to release, the request shall be
356 verified as authentic and authorized with the requesting
357 organization by the program manager, the program manager’s
358 program and support staff, or as determined in rules by the
359 department as being authentic and as having been authorized by
360 the requesting entity:
361 1. The department’s relevant health care regulatory boards
362 responsible for the licensure, regulation, or discipline of
363 practitioners, pharmacists, or other persons who are authorized
364 to prescribe, administer, or dispense controlled substances and
365 who are involved in a specific controlled substance
366 investigation involving a designated person for one or more
367 prescribed controlled substances.
368 2. The Attorney General for Medicaid fraud cases involving
369 prescribed controlled substances.
370 3. A law enforcement agency, as described in s.
371 893.0551(2)(c), during ongoing investigations as provided in s.
372 893.07 or during active investigations as defined in s. 119.011
373 regarding potential criminal activity, fraud, or theft regarding
374 prescribed controlled substances. The database information is
375 available only for criminal cases.
376 4. A patient or the legal guardian or designated health
377 care surrogate of an incapacitated patient as described in s.
378 893.0551 who, for the purpose of verifying the accuracy of the
379 database information, submits a written and notarized request
380 that includes the patient’s full name, address, and date of
381 birth, and includes the same information if the legal guardian
382 or health care surrogate submits the request. The request shall
383 be validated by the department to verify the identity of the
384 patient and the legal guardian or health care surrogate, if the
385 patient’s legal guardian or health care surrogate is the
386 requestor. Such verification is also required for any request to
387 change a patient’s prescription history or other information
388 related to his or her information in the electronic database.
389 (d) The following entities shall not be allowed direct
390 access to information in the prescription drug monitoring
391 program database but may request from the program manager and,
392 when authorized by the program manager, the program manager’s
393 program and support staff, information that contains no
394 identifying information of any patient, physician, health care
395 practitioner, prescriber, or dispenser and that is not
396 confidential and exempt:
397 1. Department staff for the purpose of calculating
398 performance measures pursuant to subsection (8).
399 2. The Program Implementation and Oversight Task Force for
400 its reporting to the Governor, the President of the Senate, and
401 the Speaker of the House of Representatives regarding the
402 prescription drug monitoring program. This subparagraph expires
403 July 1, 2012.
404 (e) All transmissions of data required by this section must
405 comply with relevant state and federal privacy and security laws
406 and regulations. However, any authorized agency or person under
407 s. 893.0551 receiving such information as allowed by s. 893.0551
408 may maintain the information received for up to 24 months before
409 purging it from his or her records or maintain it for longer
410 than 24 months if the information is pertinent to ongoing health
411 care or an active law enforcement investigation or prosecution.
412 (8) To assist in fulfilling program responsibilities,
413 performance measures shall be reported annually to the Governor,
414 the President of the Senate, and the Speaker of the House of
415 Representatives by the department each December 1, beginning in
416 2011. Data that does not contain patient, physician, health care
417 practitioner, prescriber, or dispenser identifying information
418 may be requested during the year by department employees so that
419 the department may undertake public health care and safety
420 initiatives that take advantage of observed trends. Performance
421 measures may include, but are not limited to, efforts to achieve
422 the following outcomes:
423 (a) Reduction of the rate of inappropriate use of
424 prescription drugs through department education and safety
425 efforts.
426 (b) Reduction of the quantity of pharmaceutical controlled
427 substances obtained by individuals attempting to engage in fraud
428 and deceit.
429 (c) Increased coordination among partners participating in
430 prescription drug monitoring program.
431 (d) Involvement of stakeholders in achieving improved
432 patient health care and safety and reduction of prescription
433 drug abuse and prescription drug diversion.
434 (9) Any person who willfully and knowingly fails to report
435 the dispensing of a controlled substance as required by this
436 section commits a misdemeanor of the first degree, punishable as
437 provided in s. 775.082 or s. 775.083.
438 (10) All costs incurred by the department in administering
439 the prescription drug monitoring program shall be funded through
440 federal grants or private funding applied for or received by the
441 state. The department may not commit funds for the monitoring
442 program without ensuring funding is available. The prescription
443 drug monitoring program and the implementation thereof are
444 contingent upon receipt of the nonstate funding. The department
445 and state government shall cooperate with the direct-support
446 organization established pursuant to subsection (11) in seeking
447 federal grant funds, other nonstate grant funds, gifts,
448 donations, or other private moneys for the department so long as
449 the costs of doing so are not considered material. Nonmaterial
450 costs for this purpose include, but are not limited to, the
451 costs of mailing and personnel assigned to research or apply for
452 a grant. Notwithstanding the exemptions to competitive
453 solicitation requirements under s. 287.057(5)(f), the department
454 shall comply with the competitive-solicitation requirements
455 under s. 287.057 for the procurement of any goods or services
456 required by this section.
457 (11) The Office of Drug Control, in coordination with the
458 department, may establish a direct-support organization that has
459 a board consisting of at least five members to provide
460 assistance, funding, and promotional support for the activities
461 authorized for the prescription drug monitoring program.
462 (a) As used in this subsection, the term “direct-support
463 organization” means an organization that is:
464 1. A Florida corporation not for profit incorporated under
465 chapter 617, exempted from filing fees, and approved by the
466 Department of State.
467 2. Organized and operated to conduct programs and
468 activities; raise funds; request and receive grants, gifts, and
469 bequests of money; acquire, receive, hold, and invest, in its
470 own name, securities, funds, objects of value, or other
471 property, either real or personal; and make expenditures to or
472 for the direct or indirect benefit of the department in the
473 furtherance of the prescription drug monitoring program.
474 (b) The direct-support organization is not considered a
475 lobbying firm within the meaning of s. 11.045.
476 (c) The director of the Office of Drug Control shall
477 appoint a board of directors for the direct-support
478 organization. The director may designate employees of the Office
479 of Drug Control, state employees other than state employees from
480 the department, and any other nonstate employees as appropriate,
481 to serve on the board. Members of the board shall serve at the
482 pleasure of the director of the Office of Drug Control. The
483 director shall provide guidance to members of the board to
484 ensure that moneys received by the direct-support organization
485 are not received from inappropriate sources. Inappropriate
486 sources include, but are not limited to, donors, grantors,
487 persons, or organizations that may monetarily or substantively
488 benefit from the purchase of goods or services by the department
489 in furtherance of the prescription drug monitoring program.
490 (d) The direct-support organization shall operate under
491 written contract with the Office of Drug Control. The contract
492 must, at a minimum, provide for:
493 1. Approval of the articles of incorporation and bylaws of
494 the direct-support organization by the Office of Drug Control.
495 2. Submission of an annual budget for the approval of the
496 Office of Drug Control.
497 3. Certification by the Office of Drug Control in
498 consultation with the department that the direct-support
499 organization is complying with the terms of the contract in a
500 manner consistent with and in furtherance of the goals and
501 purposes of the prescription drug monitoring program and in the
502 best interests of the state. Such certification must be made
503 annually and reported in the official minutes of a meeting of
504 the direct-support organization.
505 4. The reversion, without penalty, to the Office of Drug
506 Control, or to the state if the Office of Drug Control ceases to
507 exist, of all moneys and property held in trust by the direct
508 support organization for the benefit of the prescription drug
509 monitoring program if the direct-support organization ceases to
510 exist or if the contract is terminated.
511 5. The fiscal year of the direct-support organization,
512 which must begin July 1 of each year and end June 30 of the
513 following year.
514 6. The disclosure of the material provisions of the
515 contract to donors of gifts, contributions, or bequests,
516 including such disclosure on all promotional and fundraising
517 publications, and an explanation to such donors of the
518 distinction between the Office of Drug Control and the direct
519 support organization.
520 7. The direct-support organization’s collecting, expending,
521 and providing of funds to the department for the development,
522 implementation, and operation of the prescription drug
523 monitoring program as described in subsections (2), (3), and
524 (4). The direct-support organization may collect and expend
525 funds to be used for the functions of the direct-support
526 organization’s board of directors, as necessary and approved by
527 the director of the Office of Drug Control. In addition, the
528 direct-support organization may collect and provide funding to
529 the department in furtherance of the prescription drug
530 monitoring program by:
531 a. Establishing and administering the prescription drug
532 monitoring program’s electronic database, including hardware,
533 software, and personnel.
534 b. Conducting studies on the efficiency and effectiveness
535 of the program.
536 c. Providing funds for future enhancements of the program
537 within the intent of this section.
538 d. Providing user training of the prescription drug
539 monitoring program, including distribution of materials to
540 promote public awareness and education and conducting workshops
541 or other meetings, for health care practitioners, pharmacists,
542 and others as appropriate.
543 e. Providing funds for travel expenses.
544 f. Providing funds for administrative costs, including
545 personnel, audits, facilities, and equipment.
546 g. Fulfilling all other requirements necessary to implement
547 and operate the program as outlined in this section.
548 (e) The activities of the direct-support organization must
549 be consistent with the goals and mission of the Office of Drug
550 Control, as determined by the office in consultation with the
551 department, and in the best interests of the state. The direct
552 support organization must obtain a written approval from the
553 director of the Office of Drug Control for any activities in
554 support of the prescription drug monitoring program before
555 undertaking those activities.
556 (f) The Office of Drug Control, in consultation with the
557 department, may permit, without charge, appropriate use of
558 administrative services, property, and facilities of the Office
559 of Drug Control and the department by the direct-support
560 organization, subject to this section. The use must be directly
561 in keeping with the approved purposes of the direct-support
562 organization and may not be made at times or places that would
563 unreasonably interfere with opportunities for the public to use
564 such facilities for established purposes. Any moneys received
565 from rentals of facilities and properties managed by the Office
566 of Drug Control and the department may be held by the Office of
567 Drug Control or in a separate depository account in the name of
568 the direct-support organization and subject to the provisions of
569 the letter of agreement with the Office of Drug Control. The
570 letter of agreement must provide that any funds held in the
571 separate depository account in the name of the direct-support
572 organization must revert to the Office of Drug Control if the
573 direct-support organization is no longer approved by the Office
574 of Drug Control to operate in the best interests of the state.
575 (g) The Office of Drug Control, in consultation with the
576 department, may adopt rules under s. 120.54 to govern the use of
577 administrative services, property, or facilities of the
578 department or office by the direct-support organization.
579 (h) The Office of Drug Control may not permit the use of
580 any administrative services, property, or facilities of the
581 state by a direct-support organization if that organization does
582 not provide equal membership and employment opportunities to all
583 persons regardless of race, color, religion, gender, age, or
584 national origin.
585 (i) The direct-support organization shall provide for an
586 independent annual financial audit in accordance with s.
587 215.981. Copies of the audit shall be provided to the Office of
588 Drug Control and the Office of Policy and Budget in the
589 Executive Office of the Governor.
590 (j) The direct-support organization may not exercise any
591 power under s. 617.0302(12) or (16).
592 (12) A prescriber or dispenser may have access to the
593 information under this section which relates to a patient of
594 that prescriber or dispenser as needed for the purpose of
595 reviewing the patient’s controlled drug prescription history. A
596 prescriber or dispenser acting in good faith is immune from any
597 civil, criminal, or administrative liability that might
598 otherwise be incurred or imposed for receiving or using
599 information from the prescription drug monitoring program. This
600 subsection does not create a private cause of action, and a
601 person may not recover damages against a prescriber or dispenser
602 authorized to access information under this subsection for
603 accessing or failing to access such information.
604 (13) To the extent that funding is provided for such
605 purpose through federal or private grants or gifts and other
606 types of available moneys, the department, in collaboration with
607 the Office of Drug Control, shall study the feasibility of
608 enhancing the prescription drug monitoring program for the
609 purposes of public health initiatives and statistical reporting
610 that respects the privacy of the patient, the prescriber, and
611 the dispenser. Such a study shall be conducted in order to
612 further improve the quality of health care services and safety
613 by improving the prescribing and dispensing practices for
614 prescription drugs, taking advantage of advances in technology,
615 reducing duplicative prescriptions and the overprescribing of
616 prescription drugs, and reducing drug abuse. In addition, the
617 direct-support organization shall provide funding for the
618 department, in collaboration with the Office of Drug Control, to
619 conduct training for health care practitioners and other
620 appropriate persons in using the monitoring program to support
621 the program enhancements.
622 (14) A pharmacist, pharmacy, or dispensing health care
623 practitioner or his or her agent, before releasing a controlled
624 substance to any person not known to such dispenser, shall
625 require the person purchasing, receiving, or otherwise acquiring
626 the controlled substance to present valid photographic
627 identification or other verification of his or her identity to
628 the dispenser. If the person does not have proper
629 identification, the dispenser may verify the validity of the
630 prescription and the identity of the patient with the prescriber
631 or his or her authorized agent. This subsection does not apply
632 in an institutional setting or to a long-term care facility,
633 including, but not limited to, an assisted living facility or a
634 hospital to which patients are admitted. As used in this
635 subsection, the term “proper identification” means an
636 identification that is issued by a state or the Federal
637 Government containing the person’s photograph, printed name, and
638 signature or a document considered acceptable under 8 C.F.R.
639 274a.2(b)(1)(v)(A) and (B).
640 (15) The Agency for Health Care Administration shall
641 continue the implementation of electronic prescribing by health
642 care practitioners, health care facilities, and pharmacies under
643 s. 408.061 and the electronic prescribing clearinghouse
644 collaboration with the private sector under s. 408.0611.
645 (16) By October 1, 2010, the department shall adopt rules
646 pursuant to ss. 120.536(1) and 120.54 to administer the
647 provisions of this section.
648 Section 2. (1) The Program Implementation and Oversight
649 Task Force is created within the Executive Office of the
650 Governor. The director of the Office of Drug Control shall be a
651 nonvoting, ex officio member of the task force and shall act as
652 chair. The Office of Drug Control and the Department of Health
653 shall provide staff support for the task force.
654 (a) The following state officials shall serve on the task
655 force:
656 1. The Attorney General or his or her designee.
657 2. The Secretary of Children and Family Services or his or
658 her designee.
659 3. The Secretary of Health Care Administration or his or
660 her designee.
661 4. The State Surgeon General or his or her designee.
662 (b) In addition, the Governor shall appoint 11 members of
663 the public to serve on the task force. Of these 11 appointed
664 members, one member must have professional or occupational
665 expertise in computer security; one member must be a Florida
666 licensed, board-certified oncologist; two members must be
667 Florida-licensed, board-certified, fellowship-trained physicians
668 who have experience in pain management; one member must be a
669 Florida-licensed primary care physician who has experience in
670 prescribing scheduled prescription drugs; one member must have
671 professional or occupational expertise in e-Prescribing or
672 prescription drug monitoring programs; one member must be a
673 Florida-licensed pharmacist; one member must have professional
674 or occupational expertise in the area of law enforcement and
675 have experience in prescription drug investigations; one member
676 must have professional or occupational expertise as an
677 epidemiologist and have a background in tracking and analyzing
678 drug trends; and two members must have professional or
679 occupational expertise as providers of substance abuse
680 treatment, with priority given to a member who is a former
681 substance abuser.
682 (c) Members appointed by the Governor shall be appointed to
683 a term of 3 years each. Any vacancy on the task force shall be
684 filled in the same manner as the original appointment, and any
685 member appointed to fill a vacancy shall serve only for the
686 unexpired term of the member’s predecessor.
687 (d) Members of the task force and members of subcommittees
688 appointed under subsection (4) shall serve without compensation,
689 but are entitled to reimbursement for per diem and travel
690 expenses as provided in s. 112.061, Florida Statutes.
691 (e) The task force shall meet at least quarterly or upon
692 the call of the chair.
693 (2) The purpose of the task force is to monitor the
694 implementation and safeguarding of the electronic system
695 established for the prescription drug monitoring program under
696 s. 893.055, Florida Statutes, and to ensure privacy, protection
697 of individual medication history, and the electronic system’s
698 appropriate use by physicians, dispensers, pharmacies, law
699 enforcement agencies, and those authorized to request
700 information from the electronic system.
701 (3) The Office of Drug Control shall submit a report to the
702 Governor, the President of the Senate, and the Speaker of the
703 House of Representatives by December 1 of each year which
704 contains a summary of the work of the task force during that
705 year and the recommendations developed in accordance with the
706 task force’s purpose as provided in subsection (2). Interim
707 reports may be submitted at the discretion of the chair.
708 (4) The chair of the task force may appoint subcommittees
709 that include members of state agencies that are not represented
710 on the task force for the purpose of soliciting input and
711 recommendations from those state agencies as needed by the task
712 force to accomplish its purpose as provided in subsection (2).
713 In addition, the chair may appoint subcommittees as necessary
714 from among the members of the task force in order to efficiently
715 address specific issues. If a state agency is to be represented
716 on any subcommittee, the representative shall be the head of the
717 agency or his or her designee. The chair may designate lead and
718 contributing agencies within a subcommittee.
719 (5) The task force shall provide a final report in
720 accordance with the task force’s purpose as provided in
721 subsection (2) on July 1, 2012, to the Governor, the President
722 of the Senate, and the Speaker of the House of Representatives.
723 Such report shall be prepared using only data that does not
724 identify a patient, a prescriber, or a dispenser. The task force
725 shall expire and this section is repealed on that date unless
726 reenacted by the Legislature.
727 Section 3. Subsections (4) and (5) are added to section
728 458.309, Florida Statutes, to read:
729 458.309 Rulemaking authority.—
730 (4) Each privately owned pain-management clinic that
731 employs a physician licensed under this chapter and who is
732 primarily engaged in the treatment of pain by prescribing
733 controlled substance medications must be registered with the
734 department unless that clinic is licensed as a facility under
735 chapter 395. Each clinic location shall be licensed separately
736 regardless of whether the clinic is operated under the same
737 business name or management as another clinic. If the clinic is
738 licensed as a health care clinic under chapter 400, the medical
739 director shall be responsible for registering the facility with
740 the department. If the clinic is not licensed under chapter 395
741 or chapter 400, the clinic shall, upon registration with the
742 department, designate a physician who is responsible for
743 complying with all requirements related to registration of the
744 clinic. The designated physician shall be licensed under this
745 chapter or chapter 459 and shall practice at the office location
746 for which the physician has assumed responsibility. The
747 department shall inspect the clinic annually to ensure that it
748 complies with board rules adopted pursuant to this subsection
749 and subsection (5) unless the clinic is accredited by a
750 nationally recognized accrediting agency approved by the board.
751 The actual costs for registration and inspection or
752 accreditation shall be paid by the physician seeking to register
753 the clinic.
754 (5) The board shall adopt rules setting forth standards of
755 practice for physicians who practice in privately owned pain
756 management clinics that primarily engage in the treatment of
757 pain by prescribing controlled substance medications. Such rules
758 shall address, but need not be limited to, the following
759 subjects:
760 (a) Facility operations;
761 (b) Physical operations;
762 (c) Infection control requirements;
763 (d) Health and safety requirements;
764 (e) Quality assurance requirements;
765 (f) Patient records;
766 (g) Training requirements for all facility health care
767 practitioners;
768 (h) Inspections; and
769 (i) Data collection and reporting requirements.
770
771 A physician is primarily engaged in the treatment of pain by
772 prescribing controlled substance medications if the majority of
773 the patients seen on any day the facility is open are issued
774 controlled substance medications for the treatment of chronic
775 nonmalignant pain. Chronic nonmalignant pain is pain unrelated
776 to cancer which persists beyond the usual course of disease or
777 injury. It may or may not be associated with a pathologic
778 disease.
779 Section 4. Subsections (3) and (4) are added to section
780 459.005, Florida Statutes, to read:
781 459.005 Rulemaking authority.—
782 (3) Each privately owned pain-management clinic that
783 employs a physician licensed under this chapter and who is
784 primarily engaged in the treatment of pain by prescribing
785 controlled substance medications must be registered with the
786 department unless that clinic is licensed as a facility under
787 chapter 395. Each clinic location shall be licensed separately
788 regardless of whether the clinic is operated under the same
789 business name or management as another clinic. If the clinic is
790 licensed as a health care clinic under chapter 400, the medical
791 director shall be responsible for registering the facility with
792 the department. If the clinic is not licensed under chapter 395
793 or chapter 400, the clinic shall, upon registration with the
794 department, designate a physician who is responsible for
795 complying with all requirements related to registration of the
796 clinic. The designated physician shall be licensed under chapter
797 458 or this chapter and shall practice at the office location
798 for which the physician has assumed responsibility. The
799 department shall inspect the clinic annually to ensure that it
800 complies with board rules adopted pursuant to this subsection
801 and subsection (4) unless the clinic is accredited by a
802 nationally recognized accrediting agency approved by the board.
803 The actual costs for registration and inspection or
804 accreditation shall be paid by the physician seeking to register
805 the clinic.
806 (4) The board shall adopt rules setting forth standards of
807 practice for physicians who practice in privately owned pain
808 management clinics that primarily engage in the treatment of
809 pain by prescribing controlled substance medications. Such rules
810 shall address, but need not be limited to, the following
811 subjects:
812 (a) Facility operations;
813 (b) Physical operations;
814 (c) Infection control requirements;
815 (d) Health and safety requirements;
816 (e) Quality assurance requirements;
817 (f) Patient records;
818 (g) Training requirements for all facility health care
819 practitioners;
820 (h) Inspections; and
821 (i) Data collection and reporting requirements.
822
823 A physician is primarily engaged in the treatment of pain by
824 prescribing controlled substance medications if the majority of
825 the patients seen on any day the facility is open are issued
826 controlled substance medications for the treatment of chronic
827 nonmalignant pain. Chronic nonmalignant pain is pain unrelated
828 to cancer which persists beyond the usual course of disease or
829 injury. It may or may not be associated with a pathologic
830 disease.
831 Section 5. This act shall take effect July 1, 2009.