Florida Senate - 2009 CS for CS for CS for CS for SB 462
By the Committees on Health and Human Services Appropriations;
Governmental Oversight and Accountability; Judiciary; and Health
Regulation; and Senators Fasano and Aronberg
603-05153-09 2009462c4
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 to establish policies
10 and procedures for the system; requiring the
11 department, in consultation with the Office of Drug
12 Control and specified organizations, to adopt by rules
13 appropriate for the prescription drug monitoring
14 program; providing reporting requirements; providing a
15 reporting period; providing exemptions from
16 participation in the system; authorizing the
17 department to establish when to suspend and when to
18 resume reporting requirements during declared
19 emergencies; requiring all nonexempt, dispensing
20 pharmacists and practitioners to submit information in
21 a specified format; providing that the cost to the
22 dispenser in submitting the required information may
23 not be material or extraordinary; specifying costs
24 that are not material or extraordinary; providing
25 access to information reported to the system under
26 certain circumstances; providing that information in
27 the database for the electronic prescription drug
28 monitoring system is not discoverable or admissible in
29 any civil or administrative action; providing
30 exceptions; providing for the use of data for
31 specified purposes; providing requirements for
32 verification of information requested; requiring data
33 transmission to comply with state and federal privacy
34 and security laws; authorizing an agency or person to
35 maintain the data for a specified period if the data
36 is pertinent to active health care or law enforcement
37 investigation or prosecution; requiring the annual
38 reporting of certain performance measures to the
39 Governor and Legislature; providing performance
40 measure criteria; providing criminal penalties for
41 violations; requiring that all costs incurred by the
42 department for the program be funded through federal
43 grants or available private funding sources; providing
44 requirements for seeking funding and procuring goods
45 or services; authorizing the Office of Drug Control,
46 in coordination with the department, to establish a
47 direct-support organization; providing a definition;
48 providing for a board of directors appointed by the
49 director of the office; requiring the director to
50 provide guidance to the board regarding acceptance of
51 moneys from appropriate sources; requiring the direct
52 support organization to operate under written contract
53 with the office; providing contract requirements;
54 providing requirements for the direct-support
55 organization’s collecting, expending, and providing of
56 funds; requiring department approval of activities of
57 the direct-support organization; authorizing the
58 office to adopt rules for the use of certain
59 facilities and services; providing for audits;
60 prohibiting the direct-support organization from
61 exercising certain powers; establishing that a
62 prescriber or dispenser is not liable for good faith
63 use of the department-provided controlled substance
64 prescription information of a patient; requiring the
65 department, in collaboration with the office, to study
66 the feasibility of enhancing the prescription drug
67 monitoring program for specified purposes to the
68 extent that funding is provided for such purpose;
69 requiring certain persons to present specified
70 identification in order to obtain controlled
71 substances; providing for recordkeeping for certain
72 transactions; requiring the Agency for Health Care
73 Administration to continue the promotion of electronic
74 prescribing and an electronic prescribing
75 clearinghouse; requiring the department to adopt
76 rules; establishing a Program Implementation and
77 Oversight Task Force; providing for membership;
78 providing for reimbursement of certain member
79 expenses; providing for meetings; providing the
80 purpose of the task force; requiring reports to the
81 Governor and Legislature; providing for the creation,
82 membership, and duties of subcommittees; authorizing
83 the direct-support organization to collect, expend,
84 and provide funds and other assistance to the
85 department; providing for a final report and the
86 termination of the task force; amending ss. 458.309
87 and 459.005, F.S.; requiring certain physicians who
88 engage in pain management to register their clinics
89 with the department by a specified date; prohibiting
90 certain physicians from practicing in a pain
91 management clinic that has not registered with the
92 department; requiring the department to inspect each
93 facility; providing for exceptions; requiring the
94 physician seeking to register the clinic to pay the
95 costs of registration and inspection or accreditation;
96 requiring the Board of Medicine and the Board of
97 Osteopathic Medicine to adopt rules setting forth
98 standards of practice for certain physicians who
99 engage in pain management; providing criteria for the
100 rules; providing an effective date.
101
102 WHEREAS, as has been advocated by numerous pain management
103 experts, addiction medicine experts, pharmacists, and law
104 enforcement personnel, a prescription drug monitoring program
105 that provides for reporting and advisory information and other
106 specified information is established pursuant to this act to
107 serve as a means to promote the public health and welfare and to
108 detect and prevent controlled substance abuse and diversion, and
109 WHEREAS, while the importance and necessity of the proper
110 prescribing, dispensing, and monitoring of controlled
111 substances, particularly pain medication, have been established,
112 controlled prescription drugs are too often diverted in this
113 state, often through fraudulent means, including outright theft,
114 phony pharmacy fronts, loose Internet medical evaluations, and
115 inappropriate importation; in addition, there is a criminal
116 element that facilitates the prescription drug abuse epidemic
117 through illegal profitmaking from the diversion of certain
118 controlled substances that are prescribed or dispensed by
119 physicians, health care practitioners, and pharmacists, and
120 WHEREAS, in 2007, 8,620 drug-related deaths occurred in
121 this state, 3,159 of which were caused by prescription drugs, an
122 average of nearly 9 Floridians dying each day from prescription
123 drugs; Schedule IV benzodiazepines, such as Xanax and Valium,
124 were found to be present in more drug-related deaths than
125 cocaine; and opiate pain medications were found to be
126 contributing to the increasing numbers of drug-related deaths,
127 and
128 WHEREAS, pharmaceutical drug diversion hurts this state
129 significantly in terms of lost lives, increased crime, human
130 misery from addiction, and ballooning health care costs
131 connected to treatment, medical expenses, and Medicaid fraud
132 that all Floridians ultimately bear, and
133 WHEREAS, the intent of this act is not to interfere with
134 the legitimate medical use of controlled substances; however,
135 the people of this state are in need of and will benefit from a
136 secure and privacy-protected statewide electronic system of
137 specified prescription drug medication information created
138 primarily to encourage safer controlled substance prescription
139 decisions that reduce the number of prescription drug overdoses
140 and the number of drug overdose deaths; to educate and inform
141 health care practitioners and provide an added tool in patient
142 care, including appropriate treatment for patients who have
143 become addicted; to guide public health initiatives to educate
144 the population on the dangers of misusing prescription drugs; to
145 prevent the abuse or diversion of prescribed controlled
146 substances; and to ensure that those who need prescribed
147 controlled substances receive them in a manner that protects
148 patient confidentiality, and
149 WHEREAS, while certain medicines are very helpful if
150 properly prescribed to a patient in need and then used as
151 prescribed, they may be dangerous or even deadly if improperly
152 dispensed, misused, or diverted, and
153 WHEREAS, it is the intent of the Legislature to encourage
154 patient safety, responsible pain management, and proper access
155 to useful prescription drugs that are prescribed by a
156 knowledgeable, properly licensed health care practitioner who
157 dispenses prescription drugs and that are dispensed by a
158 pharmacist who is made aware of the patient’s prescription drug
159 medication history, thus preventing, in some cases, an abuse or
160 addiction problem from developing or worsening, making such a
161 problem possible or easier to identify, and facilitating the
162 order of appropriate medical treatment or referral, and
163 WHEREAS, such an electronic system will also aid
164 administrative and law enforcement agencies in an active
165 controlled substance-related investigation and will allow
166 decisions and recommendations for pursuing appropriate
167 administrative or criminal actions while maintaining such
168 information for any such investigation with a reasonable, good
169 faith anticipation of securing an arrest or prosecution in the
170 foreseeable future, and
171 WHEREAS, a Program Implementation and Oversight Task Force
172 will provide information to the Governor and Legislature
173 regarding the implementation of the program and ensure that
174 privacy and confidentiality of the patient’s prescription
175 history is respected, NOW, THEREFORE,
176
177 Be It Enacted by the Legislature of the State of Florida:
178
179 Section 1. Section 893.055, Florida Statutes, is created to
180 read:
181 893.055 Prescription drug monitoring program.—
182 (1) As used in this section, the term:
183 (a) “Patient advisory report” or “advisory report” means
184 information provided by the department in writing, or as
185 determined by the department, to a prescriber, dispenser,
186 pharmacy, or patient concerning the dispensing of controlled
187 substances. All advisory reports are for informational purposes
188 only and impose no obligations of any nature or any legal duty
189 on a prescriber, dispenser, pharmacy, or patient. The patient
190 advisory report shall be provided in accordance with s.
191 893.13(7)(a)8. The advisory reports issued by the department are
192 not subject to discovery or introduction into evidence in any
193 civil or administrative action against a prescriber, dispenser,
194 pharmacy, or patient arising out of matters that are the subject
195 of the report, and a person who participates in preparing,
196 reviewing, issuing, or any other activity related to an advisory
197 report may not be permitted or required to testify in any such
198 civil action as to any findings, recommendations, evaluations,
199 opinions, or other actions taken in connection with preparing,
200 reviewing, or issuing such a report.
201 (b) “Controlled substance” means a controlled substance
202 listed in Schedule II, Schedule III, or Schedule IV in s.
203 893.03.
204 (c) “Dispenser” means a pharmacy, dispensing pharmacist, or
205 dispensing health care practitioner.
206 (d) “Health care practitioner” or “practitioner” means any
207 practitioner who is subject to licensure or regulation by the
208 department under chapter 458, chapter 459, chapter 461, chapter
209 462, chapter 464, chapter 465, or chapter 466.
210 (e) “Health care regulatory board” means any board for a
211 practitioner or health care practitioner who is licensed or
212 regulated by the department.
213 (f) “Pharmacy” means any pharmacy that is subject to
214 licensure or regulation by the department under chapter 465 and
215 that dispenses or delivers a controlled substance to an
216 individual or address in this state.
217 (g) “Prescriber” means a prescribing physician, prescribing
218 practitioner, or other prescribing health care practitioner.
219 (h) “Active investigation” means an investigation that is
220 being conducted with a reasonable, good faith belief that it
221 could lead to the filing of administrative, civil, or criminal
222 proceedings, or that is ongoing and continuing and for which
223 there is a reasonable, good faith anticipation of securing an
224 arrest or prosecution in the foreseeable future.
225 (i) “Law enforcement agency” means the Department of Law
226 Enforcement, a Florida sheriff’s department, a Florida police
227 department, or a law enforcement agency of the Federal
228 Government which enforces the laws of this state or the United
229 States relating to controlled substances, and which its agents
230 and officers are empowered by law to conduct criminal
231 investigations and make arrests.
232 (2)(a) By December 1, 2010, the department shall design and
233 establish a comprehensive electronic database system that has
234 controlled substance prescriptions provided to it and that
235 provides prescription information to a patient’s health care
236 practitioner and pharmacist who inform the department that they
237 wish the patient advisory report provided to them. Otherwise,
238 the patient advisory report will not be sent to the
239 practitioner, pharmacy, or pharmacist. The system shall be
240 designed to provide information regarding dispensed
241 prescriptions of controlled substances and shall not infringe
242 upon the legitimate prescribing or dispensing of a controlled
243 substance by a prescriber or dispenser acting in good faith and
244 in the course of professional practice. The system shall be
245 consistent with standards of the American Society for Automation
246 in Pharmacy (ASAP). The electronic system shall also comply with
247 the Health Insurance Portability and Accountability Act (HIPAA)
248 as it pertains to protected health information (PHI), electronic
249 protected health information (EPHI), and all other relevant
250 state and federal privacy and security laws and regulations. The
251 department shall establish policies and procedures as
252 appropriate regarding the reporting, accessing the database,
253 evaluation, management, development, implementation, operation,
254 storage, and security of information within the system. The
255 reporting of prescribed controlled substances shall include a
256 dispensing transaction with a dispenser pursuant to chapter 465
257 or through a dispensing transaction to an individual or address
258 in this state with a pharmacy that is not located in this state
259 but that is otherwise subject to the jurisdiction of this state
260 as to that dispensing transaction. The reporting of patient
261 advisory reports refers only to reports to patients, pharmacies,
262 and practitioners. Separate reports that contain patient
263 prescription history information and that are not patient
264 advisory reports are provided to persons and entities as
265 authorized in paragraphs (7)(b) and (c) and s. 893.0551.
266 (b) The department, upon receipt of funding for the
267 prescription drug monitoring program, and in consultation with
268 the Office of Drug Control, shall adopt rules as necessary
269 concerning the reporting, accessing the database, evaluation,
270 management, development, implementation, operation, security,
271 and storage of information within the system, including rules
272 for when patient advisory reports are provided to pharmacies and
273 prescribers. The patient advisory report shall be provided in
274 accordance with s. 893.13(7)(a)8. The department shall work with
275 the professional health care licensure boards, such as the Board
276 of Medicine, the Board of Osteopathic Medicine, and the Board of
277 Pharmacy; other appropriate organizations, such as the Florida
278 Pharmacy Association, the Office of Drug Control, the Florida
279 Medical Association, the Florida Retail Federation and the
280 Florida Osteopathic Medical Association, including those
281 relating to pain management; and the Attorney General, the
282 Department of Law Enforcement, and the Agency for Health Care
283 Administration to develop rules appropriate for the prescription
284 drug monitoring program.
285 (c) All dispensers and prescribers subject to these
286 reporting requirements shall be notified by the department of
287 the implementation date for such reporting requirements.
288 (3) The pharmacy dispensing the controlled substance and
289 each prescriber who directly dispenses a controlled substance
290 shall submit to the electronic system, by a procedure and in a
291 format established by the department and consistent with an
292 ASAP-approved format, the following information for inclusion in
293 the database:
294 (a) The name of the prescribing practitioner, the
295 practitioner’s federal Drug Enforcement Administration
296 registration number, the practitioner’s National Provider
297 Identification (NPI) or other appropriate identifier, and the
298 date of the prescription.
299 (b) The date the prescription was filled and the method of
300 payment, such as cash by an individual, insurance coverage
301 through a third party, or Medicaid payment. This paragraph does
302 not authorize the department to include individual credit card
303 numbers or other account numbers in the database.
304 (c) The full name, address, and date of birth of the person
305 for whom the prescription was written.
306 (d) The name, national drug code, quantity, and strength of
307 the controlled substance dispensed.
308 (e) The full name, federal Drug Enforcement Administration
309 registration number, and address of the pharmacy or other
310 location from which the controlled substance was dispensed. If
311 the controlled substance was dispensed by a practitioner other
312 than a pharmacist, the practitioner’s full name, federal Drug
313 Enforcement Administration registration number, and address.
314 (f) The name of the pharmacy or practitioner, other than a
315 pharmacist, dispensing the controlled substance and the
316 practitioner’s National Provider Identification (NPI).
317 (g) Other appropriate identifying information as determined
318 by department rule.
319 (4) Each time a controlled substance is dispensed to an
320 individual, the controlled substance shall be reported to the
321 department through the system as soon thereafter as possible,
322 but not more than 15 days after the date the controlled
323 substance is dispensed unless an extension is approved by the
324 department for cause as determined by rule. A dispenser must
325 meet the reporting requirements of this section by providing the
326 required information concerning each controlled substance that
327 it dispensed in a department-approved, secure methodology and
328 format. Such approved formats may include, but are not limited
329 to, submission via the Internet, on a disc, or by use of regular
330 mail.
331 (5) The following are exempt from this section:
332 (a) A health care practitioner when administering a
333 controlled substance directly to a patient if the amount of the
334 controlled substance is adequate to treat the patient during
335 that particular treatment session.
336 (b) A pharmacist or health care practitioner when
337 administering a controlled substance to a patient or resident
338 receiving care as a patient at a hospital, nursing home,
339 ambulatory surgical center, hospice, or intermediate care
340 facility for the developmentally disabled which is licensed in
341 this state.
342 (c) A practitioner when administering or dispensing a
343 controlled substance in the health care system of the Department
344 of Corrections.
345 (d) A practitioner when administering a controlled
346 substance in the emergency room of a licensed hospital.
347 (e) A health care practitioner when administering or
348 dispensing a controlled substance to a person under the age of
349 16.
350 (f) A pharmacist or a dispensing practitioner when
351 dispensing a one-time, 72-hour emergency resupply of a
352 controlled substance to a patient.
353 (6) The department may establish when to suspend and when
354 to resume reporting information during a state-declared or
355 nationally declared disaster.
356 (7)(a) A practitioner or pharmacist who dispenses a
357 controlled substance must submit the information required by
358 this section in an electronic or other method in an ASAP format
359 approved by rule of the department unless otherwise provided in
360 this section. The cost to the dispenser in submitting the
361 information required by this section may not be material or
362 extraordinary. Costs not considered to be material or
363 extraordinary include, but are not limited to, regular postage,
364 electronic media, regular electronic mail, and facsimile
365 charges.
366 (b) A pharmacy, prescriber, or dispenser shall have access
367 to information in the prescription drug monitoring program’s
368 database which relates to a patient of that pharmacy,
369 prescriber, or dispenser in a manner established by the
370 department as needed for the purpose of reviewing the patient’s
371 controlled substance prescription history. Other access to the
372 program’s database shall be limited to the program’s manager and
373 to the designated program and support staff, who may act only at
374 the direction of the program manager or, in the absence of the
375 program manager, as authorized. Access by the program manager or
376 such designated staff is for prescription drug program
377 management only or for management of the program’s database and
378 its system in support of the requirements of this section and in
379 furtherance of the prescription drug monitoring program.
380 Confidential and exempt information in the database shall be
381 released only as provided in paragraph (c) and s. 893.0551.
382 (c) The following entities shall not be allowed direct
383 access to information in the prescription drug monitoring
384 program database but may request from the program manager and,
385 when authorized by the program manager, the program manager’s
386 program and support staff, information that is confidential and
387 exempt under s. 893.0551. Prior to release, the request shall be
388 verified as authentic and authorized with the requesting
389 organization by the program manager, the program manager’s
390 program and support staff, or as determined in rules by the
391 department as being authentic and as having been authorized by
392 the requesting entity:
393 1. The department or its relevant health care regulatory
394 boards responsible for the licensure, regulation, or discipline
395 of practitioners, pharmacists, or other persons who are
396 authorized to prescribe, administer, or dispense controlled
397 substances and who are involved in a specific controlled
398 substance investigation involving a designated person for one or
399 more prescribed controlled substances.
400 2. The Attorney General for Medicaid fraud cases involving
401 prescribed controlled substances.
402 3. A law enforcement agency during active investigations
403 regarding potential criminal activity, fraud, or theft regarding
404 prescribed controlled substances.
405 4. A patient or the legal guardian or designated health
406 care surrogate of an incapacitated patient as described in s.
407 893.0551 who, for the purpose of verifying the accuracy of the
408 database information, submits a written and notarized request
409 that includes the patient’s full name, address, and date of
410 birth, and includes the same information if the legal guardian
411 or health care surrogate submits the request. The request shall
412 be validated by the department to verify the identity of the
413 patient and the legal guardian or health care surrogate, if the
414 patient’s legal guardian or health care surrogate is the
415 requestor. Such verification is also required for any request to
416 change a patient’s prescription history or other information
417 related to his or her information in the electronic database.
418
419 Information in the database for the electronic prescription drug
420 monitoring system is not discoverable or admissible in any civil
421 or administrative action, except in an investigation and
422 disciplinary proceeding by the department or the appropriate
423 regulatory board.
424 (d) The following entities shall not be allowed direct
425 access to information in the prescription drug monitoring
426 program database but may request from the program manager and,
427 when authorized by the program manager, the program manager’s
428 program and support staff, information that contains no
429 identifying information of any patient, physician, health care
430 practitioner, prescriber, or dispenser and that is not
431 confidential and exempt:
432 1. Department staff for the purpose of calculating
433 performance measures pursuant to subsection (8).
434 2. The Program Implementation and Oversight Task Force for
435 its reporting to the Governor, the President of the Senate, and
436 the Speaker of the House of Representatives regarding the
437 prescription drug monitoring program. This subparagraph expires
438 July 1, 2012.
439 (e) All transmissions of data required by this section must
440 comply with relevant state and federal privacy and security laws
441 and regulations. However, any authorized agency or person under
442 s. 893.0551 receiving such information as allowed by s. 893.0551
443 may maintain the information received for up to 24 months before
444 purging it from his or her records or maintain it for longer
445 than 24 months if the information is pertinent to ongoing health
446 care or an active law enforcement investigation or prosecution.
447 (8) To assist in fulfilling program responsibilities,
448 performance measures shall be reported annually to the Governor,
449 the President of the Senate, and the Speaker of the House of
450 Representatives by the department each December 1, beginning in
451 2011. Data that does not contain patient, physician, health care
452 practitioner, prescriber, or dispenser identifying information
453 may be requested during the year by department employees so that
454 the department may undertake public health care and safety
455 initiatives that take advantage of observed trends. Performance
456 measures may include, but are not limited to, efforts to achieve
457 the following outcomes:
458 (a) Reduction of the rate of inappropriate use of
459 prescription drugs through department education and safety
460 efforts.
461 (b) Reduction of the quantity of pharmaceutical controlled
462 substances obtained by individuals attempting to engage in fraud
463 and deceit.
464 (c) Increased coordination among partners participating in
465 the prescription drug monitoring program.
466 (d) Involvement of stakeholders in achieving improved
467 patient health care and safety and reduction of prescription
468 drug abuse and prescription drug diversion.
469 (9) Any person who willfully and knowingly fails to report
470 the dispensing of a controlled substance as required by this
471 section commits a misdemeanor of the first degree, punishable as
472 provided in s. 775.082 or s. 775.083.
473 (10) All costs incurred by the department in administering
474 the prescription drug monitoring program shall be funded through
475 federal grants or private funding applied for or received by the
476 state. The department may not commit funds for the monitoring
477 program without ensuring funding is available. The prescription
478 drug monitoring program and the implementation thereof are
479 contingent upon receipt of the nonstate funding. The department
480 and state government shall cooperate with the direct-support
481 organization established pursuant to subsection (11) in seeking
482 federal grant funds, other nonstate grant funds, gifts,
483 donations, or other private moneys for the department so long as
484 the costs of doing so are not considered material. Nonmaterial
485 costs for this purpose include, but are not limited to, the
486 costs of mailing and personnel assigned to research or apply for
487 a grant. Notwithstanding the exemptions to competitive
488 solicitation requirements under s. 287.057(5)(f), the department
489 shall comply with the competitive-solicitation requirements
490 under s. 287.057 for the procurement of any goods or services
491 required by this section.
492 (11) The Office of Drug Control, in coordination with the
493 department, may establish a direct-support organization that has
494 a board consisting of at least five members to provide
495 assistance, funding, and promotional support for the activities
496 authorized for the prescription drug monitoring program.
497 (a) As used in this subsection, the term “direct-support
498 organization” means an organization that is:
499 1. A Florida corporation not for profit incorporated under
500 chapter 617, exempted from filing fees, and approved by the
501 Department of State.
502 2. Organized and operated to conduct programs and
503 activities; raise funds; request and receive grants, gifts, and
504 bequests of money; acquire, receive, hold, and invest, in its
505 own name, securities, funds, objects of value, or other
506 property, either real or personal; and make expenditures or
507 provide funding to or for the direct or indirect benefit of the
508 department in the furtherance of the prescription drug
509 monitoring program.
510 (b) The direct-support organization is not considered a
511 lobbying firm within the meaning of s. 11.045.
512 (c) The director of the Office of Drug Control shall
513 appoint a board of directors for the direct-support
514 organization. The director may designate employees of the Office
515 of Drug Control, state employees other than state employees from
516 the department, and any other nonstate employees as appropriate,
517 to serve on the board. Members of the board shall serve at the
518 pleasure of the director of the Office of Drug Control. The
519 director shall provide guidance to members of the board to
520 ensure that moneys received by the direct-support organization
521 are not received from inappropriate sources. Inappropriate
522 sources include, but are not limited to, donors, grantors,
523 persons, or organizations that may monetarily or substantively
524 benefit from the purchase of goods or services by the department
525 in furtherance of the prescription drug monitoring program.
526 (d) The direct-support organization shall operate under
527 written contract with the Office of Drug Control. The contract
528 must, at a minimum, provide for:
529 1. Approval of the articles of incorporation and bylaws of
530 the direct-support organization by the Office of Drug Control.
531 2. Submission of an annual budget for the approval of the
532 Office of Drug Control.
533 3. Certification by the Office of Drug Control in
534 consultation with the department that the direct-support
535 organization is complying with the terms of the contract in a
536 manner consistent with and in furtherance of the goals and
537 purposes of the prescription drug monitoring program and in the
538 best interests of the state. Such certification must be made
539 annually and reported in the official minutes of a meeting of
540 the direct-support organization.
541 4. The reversion, without penalty, to the Office of Drug
542 Control, or to the state if the Office of Drug Control ceases to
543 exist, of all moneys and property held in trust by the direct
544 support organization for the benefit of the prescription drug
545 monitoring program if the direct-support organization ceases to
546 exist or if the contract is terminated.
547 5. The fiscal year of the direct-support organization,
548 which must begin July 1 of each year and end June 30 of the
549 following year.
550 6. The disclosure of the material provisions of the
551 contract to donors of gifts, contributions, or bequests,
552 including such disclosure on all promotional and fundraising
553 publications, and an explanation to such donors of the
554 distinction between the Office of Drug Control and the direct
555 support organization.
556 7. The direct-support organization’s collecting, expending,
557 and providing of funds to the department for the development,
558 implementation, and operation of the prescription drug
559 monitoring program as described in this section and section 2 of
560 this act as long as the task force is authorized. The direct
561 support organization may collect and expend funds to be used for
562 the functions of the direct-support organization’s board of
563 directors, as necessary and approved by the director of the
564 Office of Drug Control. In addition, the direct-support
565 organization may collect and provide funding to the department
566 in furtherance of the prescription drug monitoring program by:
567 a. Establishing and administering the prescription drug
568 monitoring program’s electronic database, including hardware and
569 software.
570 b. Conducting studies on the efficiency and effectiveness
571 of the program to include feasibility studies as described in
572 subsection (13).
573 c. Providing funds for future enhancements of the program
574 within the intent of this section.
575 d. Providing user training of the prescription drug
576 monitoring program, including distribution of materials to
577 promote public awareness and education and conducting workshops
578 or other meetings, for health care practitioners, pharmacists,
579 and others as appropriate.
580 e. Providing funds for travel expenses.
581 f. Providing funds for administrative costs, including
582 personnel, audits, facilities, and equipment.
583 g. Fulfilling all other requirements necessary to implement
584 and operate the program as outlined in this section.
585 (e) The activities of the direct-support organization must
586 be consistent with the goals and mission of the Office of Drug
587 Control, as determined by the office in consultation with the
588 department, and in the best interests of the state. The direct
589 support organization must obtain a written approval from the
590 director of the Office of Drug Control for any activities in
591 support of the prescription drug monitoring program before
592 undertaking those activities.
593 (f) The Office of Drug Control, in consultation with the
594 department, may permit, without charge, appropriate use of
595 administrative services, property, and facilities of the Office
596 of Drug Control and the department by the direct-support
597 organization, subject to this section. The use must be directly
598 in keeping with the approved purposes of the direct-support
599 organization and may not be made at times or places that would
600 unreasonably interfere with opportunities for the public to use
601 such facilities for established purposes. Any moneys received
602 from rentals of facilities and properties managed by the Office
603 of Drug Control and the department may be held by the Office of
604 Drug Control or in a separate depository account in the name of
605 the direct-support organization and subject to the provisions of
606 the letter of agreement with the Office of Drug Control. The
607 letter of agreement must provide that any funds held in the
608 separate depository account in the name of the direct-support
609 organization must revert to the Office of Drug Control if the
610 direct-support organization is no longer approved by the Office
611 of Drug Control to operate in the best interests of the state.
612 (g) The Office of Drug Control, in consultation with the
613 department, may adopt rules under s. 120.54 to govern the use of
614 administrative services, property, or facilities of the
615 department or office by the direct-support organization.
616 (h) The Office of Drug Control may not permit the use of
617 any administrative services, property, or facilities of the
618 state by a direct-support organization if that organization does
619 not provide equal membership and employment opportunities to all
620 persons regardless of race, color, religion, gender, age, or
621 national origin.
622 (i) The direct-support organization shall provide for an
623 independent annual financial audit in accordance with s.
624 215.981. Copies of the audit shall be provided to the Office of
625 Drug Control and the Office of Policy and Budget in the
626 Executive Office of the Governor.
627 (j) The direct-support organization may not exercise any
628 power under s. 617.0302(12) or (16).
629 (12) A prescriber or dispenser may have access to the
630 information under this section which relates to a patient of
631 that prescriber or dispenser as needed for the purpose of
632 reviewing the patient’s controlled drug prescription history. A
633 prescriber or dispenser acting in good faith is immune from any
634 civil, criminal, or administrative liability that might
635 otherwise be incurred or imposed for receiving or using
636 information from the prescription drug monitoring program. This
637 subsection does not create a private cause of action, and a
638 person may not recover damages against a prescriber or dispenser
639 authorized to access information under this subsection for
640 accessing or failing to access such information.
641 (13) To the extent that funding is provided for such
642 purpose through federal or private grants or gifts and other
643 types of available moneys, the department, in collaboration with
644 the Office of Drug Control, shall study the feasibility of
645 enhancing the prescription drug monitoring program for the
646 purposes of public health initiatives and statistical reporting
647 that respects the privacy of the patient, the prescriber, and
648 the dispenser. Such a study shall be conducted in order to
649 further improve the quality of health care services and safety
650 by improving the prescribing and dispensing practices for
651 prescription drugs, taking advantage of advances in technology,
652 reducing duplicative prescriptions and the overprescribing of
653 prescription drugs, and reducing drug abuse. The requirements of
654 the National All Schedules Prescription Electronic Reporting
655 (NASPER) Act are authorized in order to apply for federal NASPER
656 funding. In addition, the direct-support organization shall
657 provide funding for the department, in collaboration with the
658 Office of Drug Control, to conduct training for health care
659 practitioners and other appropriate persons in using the
660 monitoring program to support the program enhancements.
661 (14) A pharmacist, pharmacy, or dispensing health care
662 practitioner or his or her agent, before releasing a controlled
663 substance to any person not known to such dispenser, shall
664 require the person purchasing, receiving, or otherwise acquiring
665 the controlled substance to present valid photographic
666 identification or other verification of his or her identity to
667 the dispenser. If the person does not have proper
668 identification, the dispenser may verify the validity of the
669 prescription and the identity of the patient with the prescriber
670 or his or her authorized agent. Verification of health plan
671 eligibility through a real-time inquiry or adjudication system
672 will be considered to be proper identification. This subsection
673 does not apply in an institutional setting or to a long-term
674 care facility, including, but not limited to, an assisted living
675 facility or a hospital to which patients are admitted. As used
676 in this subsection, the term “proper identification” means an
677 identification that is issued by a state or the Federal
678 Government containing the person’s photograph, printed name, and
679 signature or a document considered acceptable under 8 C.F.R.
680 274a.2(b)(1)(v)(A) and (B).
681 (15) The Agency for Health Care Administration shall
682 continue the promotion of electronic prescribing by health care
683 practitioners, health care facilities, and pharmacies under s.
684 408.0611.
685 (16) By October 1, 2010, the department shall adopt rules
686 pursuant to ss. 120.536(1) and 120.54 to administer the
687 provisions of this section, which shall include as necessary the
688 reporting, accessing, evaluation, management, development,
689 implementation, operation, and storage of information within the
690 monitoring program’s system.
691 Section 2. (1) The Program Implementation and Oversight
692 Task Force is created within the Executive Office of the
693 Governor. The director of the Office of Drug Control shall be a
694 nonvoting, ex officio member of the task force and shall act as
695 chair. The Office of Drug Control and the Department of Health
696 shall provide staff support for the task force.
697 (a) The following state officials shall serve on the task
698 force:
699 1. The Attorney General or his or her designee.
700 2. The Secretary of Children and Family Services or his or
701 her designee.
702 3. The Secretary of Health Care Administration or his or
703 her designee.
704 4. The State Surgeon General or his or her designee.
705 (b) In addition, the Governor shall appoint 12 members of
706 the public to serve on the task force. Of these 12 appointed
707 members, one member must have professional or occupational
708 expertise in computer security; one member must be a Florida
709 licensed, board-certified oncologist; two members must be
710 Florida-licensed, fellowship-trained, pain-medicine physicians;
711 one member must be a Florida-licensed primary care physician who
712 has experience in prescribing scheduled prescription drugs; one
713 member must have professional or occupational expertise in e
714 Prescribing or prescription drug monitoring programs; two
715 members must be a Florida-licensed pharmacists; one member must
716 have professional or occupational expertise in the area of law
717 enforcement and have experience in prescription drug
718 investigations; one member must have professional or
719 occupational expertise as an epidemiologist and have a
720 background in tracking and analyzing drug trends; and two
721 members must have professional or occupational expertise as
722 providers of substance abuse treatment, with priority given to a
723 member who is a former substance abuser.
724 (c) Members appointed by the Governor shall be appointed to
725 a term of 3 years each. Any vacancy on the task force shall be
726 filled in the same manner as the original appointment, and any
727 member appointed to fill a vacancy shall serve only for the
728 unexpired term of the member’s predecessor.
729 (d) Members of the task force and members of subcommittees
730 appointed under subsection (4) shall serve without compensation,
731 but are entitled to reimbursement for per diem and travel
732 expenses as provided in s. 112.061, Florida Statutes.
733 (e) The task force shall meet at least quarterly or upon
734 the call of the chair.
735 (2) The purpose of the task force is to monitor the
736 implementation and safeguarding of the electronic system
737 established for the prescription drug monitoring program under
738 s. 893.055, Florida Statutes, and to ensure privacy, protection
739 of individual medication history, and the electronic system’s
740 appropriate use by physicians, dispensers, pharmacies, law
741 enforcement agencies, and those authorized to request
742 information from the electronic system.
743 (3) The Office of Drug Control shall submit a report to the
744 Governor, the President of the Senate, and the Speaker of the
745 House of Representatives by December 1 of each year which
746 contains a summary of the work of the task force during that
747 year and the recommendations developed in accordance with the
748 task force’s purpose as provided in subsection (2). Interim
749 reports may be submitted at the discretion of the chair.
750 (4) The chair of the task force may appoint subcommittees
751 that include members of state agencies that are not represented
752 on the task force for the purpose of soliciting input and
753 recommendations from those state agencies as needed by the task
754 force to accomplish its purpose as provided in subsection (2).
755 In addition, the chair may appoint subcommittees as necessary
756 from among the members of the task force in order to efficiently
757 address specific issues. If a state agency is to be represented
758 on any subcommittee, the representative shall be the head of the
759 agency or his or her designee. The chair may designate lead and
760 contributing agencies within a subcommittee.
761 (5) The direct-support organization created in s. 893.055,
762 Florida Statutes, may collect, expend, and provide funds and
763 other assistance to the department for the development,
764 implementation, and operation of the task force.
765 (6) The task force shall provide a final report in
766 accordance with the task force’s purpose as provided in
767 subsection (2) on July 1, 2012, to the Governor, the President
768 of the Senate, and the Speaker of the House of Representatives.
769 Such report shall be prepared using only data that does not
770 identify a patient, a prescriber, or a dispenser. The task force
771 shall expire and this section is repealed on that date unless
772 reenacted by the Legislature.
773 Section 3. Subsections (4) and (5) are added to section
774 458.309, Florida Statutes, to read:
775 458.309 Rulemaking authority.—
776 (4) All privately owned pain-management clinics,
777 facilities, or offices, hereinafter referred to as “clinics,”
778 which advertise in any medium for any type of pain-management
779 services, or employ a physician who is primarily engaged in the
780 treatment of pain by prescribing or dispensing controlled
781 substance medications, must register with the department by
782 January 4, 2010, unless that clinic is licensed as a facility
783 pursuant to chapter 395. A physician may not practice medicine
784 in a pain-management clinic that is required to but has not
785 registered with the department. Each clinic location shall be
786 registered separately regardless of whether the clinic is
787 operated under the same business name or management as another
788 clinic. If the clinic is licensed as a health care clinic under
789 chapter 400, the medical director is responsible for registering
790 the facility with the department. If the clinic is not
791 registered pursuant to chapter 395 or chapter 400, the clinic
792 shall, upon registration with the department, designate a
793 physician who is responsible for complying with all requirements
794 related to registration of the clinic. The designated physician
795 shall be licensed under this chapter or chapter 459 and shall
796 practice at the office location for which the physician has
797 assumed responsibility. The department shall inspect the clinic
798 annually to ensure that it complies with rules of the Board of
799 Medicine adopted pursuant to this subsection and subsection (5)
800 unless the office is accredited by a nationally recognized
801 accrediting agency approved by the Board of Medicine. The actual
802 costs for registration and inspection or accreditation shall be
803 paid by the physician seeking to register the clinic.
804 (5) The Board of Medicine shall adopt rules setting forth
805 standards of practice for physicians practicing in privately
806 owned pain-management clinics that primarily engage in the
807 treatment of pain by prescribing or dispensing controlled
808 substance medications. Such rules shall address, but need not be
809 limited to, the following subjects:
810 (a) Facility operations;
811 (b) Physical operations;
812 (c) Infection control requirements;
813 (d) Health and safety requirements;
814 (e) Quality assurance requirements;
815 (f) Patient records;
816 (g) Training requirements for all facility health care
817 practitioners who are not regulated by another board;
818 (h) Inspections; and
819 (i) Data collection and reporting requirements.
820
821 A physician is primarily engaged in the treatment of pain by
822 prescribing or dispensing controlled substance medications when
823 the majority of the patients seen are prescribed or dispensed
824 controlled substance medications for the treatment of chronic
825 nonmalignant pain. Chronic nonmalignant pain is pain unrelated
826 to cancer which persists beyond the usual course of the disease
827 or the injury that is the cause of the pain or more than 90 days
828 after surgery.
829 Section 4. Subsections (3) and (4) are added to section
830 459.005, Florida Statutes, to read:
831 459.005 Rulemaking authority.—
832 (3) All privately owned pain-management clinics,
833 facilities, or offices, hereinafter referred to as “clinics,”
834 which advertise in any medium for any type of pain-management
835 services, or employ a physician who is licensed under this
836 chapter and who is primarily engaged in the treatment of pain by
837 prescribing or dispensing controlled substance medications, must
838 register with the department by January 4, 2010, unless that
839 clinic is licensed as a facility under chapter 395. A physician
840 may not practice osteopathic medicine in a pain-management
841 clinic that is required to but has not registered with the
842 department. Each clinic location shall be registered separately
843 regardless of whether the clinic is operated under the same
844 business name or management as another clinic. If the clinic is
845 licensed as a health care clinic under chapter 400, the medical
846 director is responsible for registering the facility with the
847 department. If the clinic is not registered under chapter 395 or
848 chapter 400, the clinic shall, upon registration with the
849 department, designate a physician who is responsible for
850 complying with all requirements related to registration of the
851 clinic. The designated physician shall be licensed under chapter
852 458 or this chapter and shall practice at the office location
853 for which the physician has assumed responsibility. The
854 department shall inspect the clinic annually to ensure that it
855 complies with rules of the Board of Osteopathic Medicine adopted
856 pursuant to this subsection and subsection (4) unless the office
857 is accredited by a nationally recognized accrediting agency
858 approved by the Board of Osteopathic Medicine. The actual costs
859 for registration and inspection or accreditation shall be paid
860 by the physician seeking to register the clinic.
861 (4) The Board of Osteopathic Medicine shall adopt rules
862 setting forth standards of practice for physicians who practice
863 in privately owned pain-management clinics that primarily engage
864 in the treatment of pain by prescribing or dispensing controlled
865 substance medications. Such rules shall address, but need not be
866 limited to, the following subjects:
867 (a) Facility operations;
868 (b) Physical operations;
869 (c) Infection control requirements;
870 (d) Health and safety requirements;
871 (e) Quality assurance requirements;
872 (f) Patient records;
873 (g) Training requirements for all facility health care
874 practitioners who are not regulated by another board;
875 (h) Inspections; and
876 (i) Data collection and reporting requirements.
877
878 A physician is primarily engaged in the treatment of pain by
879 prescribing or dispensing controlled substance medications when
880 the majority of the patients seen are prescribed or dispensed
881 controlled substance medications for the treatment of chronic
882 nonmalignant pain. Chronic nonmalignant pain is pain unrelated
883 to cancer which persists beyond the usual course of the disease
884 or the injury that is the cause of the pain or more than 90 days
885 after surgery.
886 Section 5. This act shall take effect July 1, 2009.