Florida Senate - 2009 COMMITTEE AMENDMENT
Bill No. CS for CS for CS for SB 462
Barcode 178344
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
04/15/2009 .
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The Committee on Health and Human Services Appropriations
(Haridopolos) recommended the following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Section 893.055, Florida Statutes, is created to
6 read:
7 893.055 Prescription drug monitoring program.—
8 (1) As used in this section, the term:
9 (a) “Patient advisory report” or “advisory report” means
10 information provided by the department in writing, or as
11 determined by the department, to a prescriber, dispenser,
12 pharmacy, or patient concerning the dispensing of controlled
13 substances. All advisory reports are for informational purposes
14 only and impose no obligations of any nature or any legal duty
15 on a prescriber, dispenser, pharmacy, or patient. The patient
16 advisory report shall be provided in accordance with s.
17 893.13(7)(a)8. The advisory reports issued by the department are
18 not subject to discovery or introduction into evidence in any
19 civil or administrative action against a prescriber, dispenser,
20 pharmacy, or patient arising out of matters that are the subject
21 of the report, and a person who participates in preparing,
22 reviewing, issuing, or any other activity related to an advisory
23 report may not be permitted or required to testify in any such
24 civil action as to any findings, recommendations, evaluations,
25 opinions, or other actions taken in connection with preparing,
26 reviewing, or issuing such a report.
27 (b) “Controlled substance” means a controlled substance
28 listed in Schedule II, Schedule III, or Schedule IV in s.
29 893.03.
30 (c) “Dispenser” means a pharmacy, dispensing pharmacist, or
31 dispensing health care practitioner.
32 (d) “Health care practitioner” or “practitioner” means any
33 practitioner who is subject to licensure or regulation by the
34 department under chapter 458, chapter 459, chapter 461, chapter
35 462, chapter 464, chapter 465, or chapter 466.
36 (e) “Health care regulatory board” means any board for a
37 practitioner or health care practitioner who is licensed or
38 regulated by the department.
39 (f) “Pharmacy” means any pharmacy that is subject to
40 licensure or regulation by the department under chapter 465 and
41 that dispenses or delivers a controlled substance to an
42 individual or address in this state.
43 (g) “Prescriber” means a prescribing physician, prescribing
44 practitioner, or other prescribing health care practitioner.
45 (h) “Active investigation” means an investigation that is
46 being conducted with a reasonable, good faith belief that it
47 could lead to the filing of administrative, civil, or criminal
48 proceedings, or that is ongoing and continuing and for which
49 there is a reasonable, good faith anticipation of securing an
50 arrest or prosecution in the foreseeable future.
51 (i) “Law enforcement agency” means the Department of Law
52 Enforcement, a Florida sheriff’s department, a Florida police
53 department, or a law enforcement agency of the Federal
54 Government which enforces the laws of this state or the United
55 States relating to controlled substances, and which its agents
56 and officers are empowered by law to conduct criminal
57 investigations and make arrests.
58 (2)(a) By December 1, 2010, the department shall design and
59 establish a comprehensive electronic database system that has
60 controlled substance prescriptions provided to it and that
61 provides prescription information to a patient’s health care
62 practitioner and pharmacist who inform the department that they
63 wish the patient advisory report provided to them. Otherwise,
64 the patient advisory report will not be sent to the
65 practitioner, pharmacy, or pharmacist. The system shall be
66 designed to provide information regarding dispensed
67 prescriptions of controlled substances and shall not infringe
68 upon the legitimate prescribing or dispensing of a controlled
69 substance by a prescriber or dispenser acting in good faith and
70 in the course of professional practice. The system shall be
71 consistent with standards of the American Society for Automation
72 in Pharmacy (ASAP). The electronic system shall also comply with
73 the Health Insurance Portability and Accountability Act (HIPAA)
74 as it pertains to protected health information (PHI), electronic
75 protected health information (EPHI), and all other relevant
76 state and federal privacy and security laws and regulations. The
77 department shall establish policies and procedures as
78 appropriate regarding the reporting, accessing the database,
79 evaluation, management, development, implementation, operation,
80 storage, and security of information within the system. The
81 reporting of prescribed controlled substances shall include a
82 dispensing transaction with a dispenser pursuant to chapter 465
83 or through a dispensing transaction to an individual or address
84 in this state with a pharmacy that is not located in this state
85 but that is otherwise subject to the jurisdiction of this state
86 as to that dispensing transaction. The reporting of patient
87 advisory reports refers only to reports to patients, pharmacies,
88 and practitioners. Separate reports that contain patient
89 prescription history information and that are not patient
90 advisory reports are provided to persons and entities as
91 authorized in paragraphs (7)(b) and (c) and s. 893.0551.
92 (b) The department, in coordination with the Office of Drug
93 Control, shall adopt rules as necessary concerning the
94 reporting, accessing the database, evaluation, management,
95 development, implementation, operation, security, and storage of
96 information within the system, including rules for when patient
97 advisory reports are provided to pharmacies and prescribers. The
98 patient advisory report shall be provided in accordance with s.
99 893.13(7)(a)8. The department shall work with the professional
100 health care licensure boards, such as the Board of Medicine, the
101 Board of Osteopathic Medicine, and the Board of Pharmacy; other
102 appropriate organizations, such as the Florida Pharmacy
103 Association, the Office of Drug Control, the Florida Medical
104 Association, the Florida Retail Federation and the Florida
105 Osteopathic Medical Association, including those relating to
106 pain management; and the Attorney General, the Department of Law
107 Enforcement, and the Agency for Health Care Administration to
108 develop rules appropriate for the prescription drug monitoring
109 program.
110 (c) All dispensers and prescribers subject to these
111 reporting requirements shall be notified by the department of
112 the implementation date for such reporting requirements.
113 (3) The pharmacy dispensing the controlled substance and
114 each prescriber who directly dispenses a controlled substance
115 shall submit to the electronic system, by a procedure and in a
116 format established by the department and consistent with an
117 ASAP-approved format, the following information for inclusion in
118 the database:
119 (a) The name of the prescribing practitioner, the
120 practitioner’s federal Drug Enforcement Administration
121 registration number, the practitioner’s National Provider
122 Identification (NPI) or other appropriate identifier, and the
123 date of the prescription.
124 (b) The date the prescription was filled and the method of
125 payment, such as cash by an individual, insurance coverage
126 through a third party, or Medicaid payment. This paragraph does
127 not authorize the department to include individual credit card
128 numbers or other account numbers in the database.
129 (c) The full name, address, and date of birth of the person
130 for whom the prescription was written.
131 (d) The name, national drug code, quantity, and strength of
132 the controlled substance dispensed.
133 (e) The full name, federal Drug Enforcement Administration
134 registration number, and address of the pharmacy or other
135 location from which the controlled substance was dispensed. If
136 the controlled substance was dispensed by a practitioner other
137 than a pharmacist, the practitioner’s full name, federal Drug
138 Enforcement Administration registration number, and address.
139 (f) The name of the pharmacy or practitioner, other than a
140 pharmacist, dispensing the controlled substance and the
141 practitioner’s National Provider Identification (NPI).
142 (g) Other appropriate identifying information as determined
143 by department rule.
144 (4) Each time a controlled substance is dispensed to an
145 individual, the controlled substance shall be reported to the
146 department through the system as soon thereafter as possible,
147 but not more than 15 days after the date the controlled
148 substance is dispensed unless an extension is approved by the
149 department for cause as determined by rule. A dispenser must
150 meet the reporting requirements of this section by providing the
151 required information concerning each controlled substance that
152 it dispensed in a department-approved, secure methodology and
153 format. Such approved formats may include, but are not limited
154 to, submission via the Internet, on a disc, or by use of regular
155 mail.
156 (5) The following are exempt from this section:
157 (a) A health care practitioner when administering a
158 controlled substance directly to a patient if the amount of the
159 controlled substance is adequate to treat the patient during
160 that particular treatment session.
161 (b) A pharmacist or health care practitioner when
162 administering a controlled substance to a patient or resident
163 receiving care as a patient at a hospital, nursing home,
164 ambulatory surgical center, hospice, or intermediate care
165 facility for the developmentally disabled which is licensed in
166 this state.
167 (c) A practitioner when administering or dispensing a
168 controlled substance in the health care system of the Department
169 of Corrections.
170 (d) A practitioner when administering a controlled
171 substance in the emergency room of a licensed hospital.
172 (e) A health care practitioner when administering or
173 dispensing a controlled substance to a person under the age of
174 16.
175 (f) A pharmacist or a dispensing practitioner when
176 dispensing a one-time, 72-hour emergency resupply of a
177 controlled substance to a patient.
178 (6) The department may establish when to suspend and when
179 to resume reporting information during a state-declared or
180 nationally declared disaster.
181 (7)(a) A practitioner or pharmacist who dispenses a
182 controlled substance must submit the information required by
183 this section in an electronic or other method in an ASAP format
184 approved by rule of the department unless otherwise provided in
185 this section. The cost to the dispenser in submitting the
186 information required by this section may not be material or
187 extraordinary. Costs not considered to be material or
188 extraordinary include, but are not limited to, regular postage,
189 electronic media, regular electronic mail, and facsimile
190 charges.
191 (b) A pharmacy, prescriber, or dispenser shall have access
192 to information in the prescription drug monitoring program’s
193 database which relates to a patient of that pharmacy,
194 prescriber, or dispenser in a manner established by the
195 department as needed for the purpose of reviewing the patient’s
196 controlled substance prescription history. Other access to the
197 program’s database shall be limited to the program’s manager and
198 to the designated program and support staff, who may act only at
199 the direction of the program manager or, in the absence of the
200 program manager, as authorized. Access by the program manager or
201 such designated staff is for prescription drug program
202 management only or for management of the program’s database and
203 its system in support of the requirements of this section and in
204 furtherance of the prescription drug monitoring program.
205 Confidential and exempt information in the database shall be
206 released only as provided in paragraph (c) and s. 893.0551.
207 (c) The following entities shall not be allowed direct
208 access to information in the prescription drug monitoring
209 program database but may request from the program manager and,
210 when authorized by the program manager, the program manager’s
211 program and support staff, information that is confidential and
212 exempt under s. 893.0551. Prior to release, the request shall be
213 verified as authentic and authorized with the requesting
214 organization by the program manager, the program manager’s
215 program and support staff, or as determined in rules by the
216 department as being authentic and as having been authorized by
217 the requesting entity:
218 1. The department’s relevant health care regulatory boards
219 responsible for the licensure, regulation, or discipline of
220 practitioners, pharmacists, or other persons who are authorized
221 to prescribe, administer, or dispense controlled substances and
222 who are involved in a specific controlled substance
223 investigation involving a designated person for one or more
224 prescribed controlled substances.
225 2. The Attorney General for Medicaid fraud cases involving
226 prescribed controlled substances.
227 3. A law enforcement agency during active investigations
228 regarding potential criminal activity, fraud, or theft regarding
229 prescribed controlled substances.
230 4. A patient or the legal guardian or designated health
231 care surrogate of an incapacitated patient as described in s.
232 893.0551 who, for the purpose of verifying the accuracy of the
233 database information, submits a written and notarized request
234 that includes the patient’s full name, address, and date of
235 birth, and includes the same information if the legal guardian
236 or health care surrogate submits the request. The request shall
237 be validated by the department to verify the identity of the
238 patient and the legal guardian or health care surrogate, if the
239 patient’s legal guardian or health care surrogate is the
240 requestor. Such verification is also required for any request to
241 change a patient’s prescription history or other information
242 related to his or her information in the electronic database.
243
244 Information in the database for the electronic prescription
245 drug monitoring system is not discoverable or admissible in any
246 civil or administrative action, except in an investigation and
247 disciplinary proceeding by the department or the appropriate
248 regulatory board.
249 (d) The following entities shall not be allowed direct
250 access to information in the prescription drug monitoring
251 program database but may request from the program manager and,
252 when authorized by the program manager, the program manager’s
253 program and support staff, information that contains no
254 identifying information of any patient, physician, health care
255 practitioner, prescriber, or dispenser and that is not
256 confidential and exempt:
257 1. Department staff for the purpose of calculating
258 performance measures pursuant to subsection (8).
259 2. The Program Implementation and Oversight Task Force for
260 its reporting to the Governor, the President of the Senate, and
261 the Speaker of the House of Representatives regarding the
262 prescription drug monitoring program. This subparagraph expires
263 July 1, 2012.
264 (e) All transmissions of data required by this section must
265 comply with relevant state and federal privacy and security laws
266 and regulations. However, any authorized agency or person under
267 s. 893.0551 receiving such information as allowed by s. 893.0551
268 may maintain the information received for up to 24 months before
269 purging it from his or her records or maintain it for longer
270 than 24 months if the information is pertinent to ongoing health
271 care or an active law enforcement investigation or prosecution.
272 (8) To assist in fulfilling program responsibilities,
273 performance measures shall be reported annually to the Governor,
274 the President of the Senate, and the Speaker of the House of
275 Representatives by the department each December 1, beginning in
276 2011. Data that does not contain patient, physician, health care
277 practitioner, prescriber, or dispenser identifying information
278 may be requested during the year by department employees so that
279 the department may undertake public health care and safety
280 initiatives that take advantage of observed trends. Performance
281 measures may include, but are not limited to, efforts to achieve
282 the following outcomes:
283 (a) Reduction of the rate of inappropriate use of
284 prescription drugs through department education and safety
285 efforts.
286 (b) Reduction of the quantity of pharmaceutical controlled
287 substances obtained by individuals attempting to engage in fraud
288 and deceit.
289 (c) Increased coordination among partners participating in
290 the prescription drug monitoring program.
291 (d) Involvement of stakeholders in achieving improved
292 patient health care and safety and reduction of prescription
293 drug abuse and prescription drug diversion.
294 (9) Any person who willfully and knowingly fails to report
295 the dispensing of a controlled substance as required by this
296 section commits a misdemeanor of the first degree, punishable as
297 provided in s. 775.082 or s. 775.083.
298 (10) All costs incurred by the department in administering
299 the prescription drug monitoring program shall be funded through
300 federal grants or private funding applied for or received by the
301 state. The department may not commit funds for the monitoring
302 program without ensuring funding is available. The prescription
303 drug monitoring program and the implementation thereof are
304 contingent upon receipt of the nonstate funding. The department
305 and state government shall cooperate with the direct-support
306 organization established pursuant to subsection (11) in seeking
307 federal grant funds, other nonstate grant funds, gifts,
308 donations, or other private moneys for the department so long as
309 the costs of doing so are not considered material. Nonmaterial
310 costs for this purpose include, but are not limited to, the
311 costs of mailing and personnel assigned to research or apply for
312 a grant. Notwithstanding the exemptions to competitive
313 solicitation requirements under s. 287.057(5)(f), the department
314 shall comply with the competitive-solicitation requirements
315 under s. 287.057 for the procurement of any goods or services
316 required by this section.
317 (11) The Office of Drug Control, in coordination with the
318 department, may establish a direct-support organization that has
319 a board consisting of at least five members to provide
320 assistance, funding, and promotional support for the activities
321 authorized for the prescription drug monitoring program.
322 (a) As used in this subsection, the term “direct-support
323 organization” means an organization that is:
324 1. A Florida corporation not for profit incorporated under
325 chapter 617, exempted from filing fees, and approved by the
326 Department of State.
327 2. Organized and operated to conduct programs and
328 activities; raise funds; request and receive grants, gifts, and
329 bequests of money; acquire, receive, hold, and invest, in its
330 own name, securities, funds, objects of value, or other
331 property, either real or personal; and make expenditures or
332 provide funding to or for the direct or indirect benefit of the
333 department in the furtherance of the prescription drug
334 monitoring program.
335 (b) The direct-support organization is not considered a
336 lobbying firm within the meaning of s. 11.045.
337 (c) The director of the Office of Drug Control shall
338 appoint a board of directors for the direct-support
339 organization. The director may designate employees of the Office
340 of Drug Control, state employees other than state employees from
341 the department, and any other nonstate employees as appropriate,
342 to serve on the board. Members of the board shall serve at the
343 pleasure of the director of the Office of Drug Control. The
344 director shall provide guidance to members of the board to
345 ensure that moneys received by the direct-support organization
346 are not received from inappropriate sources. Inappropriate
347 sources include, but are not limited to, donors, grantors,
348 persons, or organizations that may monetarily or substantively
349 benefit from the purchase of goods or services by the department
350 in furtherance of the prescription drug monitoring program.
351 (d) The direct-support organization shall operate under
352 written contract with the Office of Drug Control. The contract
353 must, at a minimum, provide for:
354 1. Approval of the articles of incorporation and bylaws of
355 the direct-support organization by the Office of Drug Control.
356 2. Submission of an annual budget for the approval of the
357 Office of Drug Control.
358 3. Certification by the Office of Drug Control in
359 consultation with the department that the direct-support
360 organization is complying with the terms of the contract in a
361 manner consistent with and in furtherance of the goals and
362 purposes of the prescription drug monitoring program and in the
363 best interests of the state. Such certification must be made
364 annually and reported in the official minutes of a meeting of
365 the direct-support organization.
366 4. The reversion, without penalty, to the Office of Drug
367 Control, or to the state if the Office of Drug Control ceases to
368 exist, of all moneys and property held in trust by the direct
369 support organization for the benefit of the prescription drug
370 monitoring program if the direct-support organization ceases to
371 exist or if the contract is terminated.
372 5. The fiscal year of the direct-support organization,
373 which must begin July 1 of each year and end June 30 of the
374 following year.
375 6. The disclosure of the material provisions of the
376 contract to donors of gifts, contributions, or bequests,
377 including such disclosure on all promotional and fundraising
378 publications, and an explanation to such donors of the
379 distinction between the Office of Drug Control and the direct
380 support organization.
381 7. The direct-support organization’s collecting, expending,
382 and providing of funds to the department for the development,
383 implementation, and operation of the prescription drug
384 monitoring program as described in this section and section 2 of
385 this act as long as the task force is authorized. The direct
386 support organization may collect and expend funds to be used for
387 the functions of the direct-support organization’s board of
388 directors, as necessary and approved by the director of the
389 Office of Drug Control. In addition, the direct-support
390 organization may collect and provide funding to the department
391 in furtherance of the prescription drug monitoring program by:
392 a. Establishing and administering the prescription drug
393 monitoring program’s electronic database, including hardware and
394 software.
395 b. Conducting studies on the efficiency and effectiveness
396 of the program to include feasibility studies as described in
397 subsection (13).
398 c. Providing funds for future enhancements of the program
399 within the intent of this section.
400 d. Providing user training of the prescription drug
401 monitoring program, including distribution of materials to
402 promote public awareness and education and conducting workshops
403 or other meetings, for health care practitioners, pharmacists,
404 and others as appropriate.
405 e. Providing funds for travel expenses.
406 f. Providing funds for administrative costs, including
407 personnel, audits, facilities, and equipment.
408 g. Fulfilling all other requirements necessary to implement
409 and operate the program as outlined in this section.
410 (e) The activities of the direct-support organization must
411 be consistent with the goals and mission of the Office of Drug
412 Control, as determined by the office in consultation with the
413 department, and in the best interests of the state. The direct
414 support organization must obtain a written approval from the
415 director of the Office of Drug Control for any activities in
416 support of the prescription drug monitoring program before
417 undertaking those activities.
418 (f) The Office of Drug Control, in consultation with the
419 department, may permit, without charge, appropriate use of
420 administrative services, property, and facilities of the Office
421 of Drug Control and the department by the direct-support
422 organization, subject to this section. The use must be directly
423 in keeping with the approved purposes of the direct-support
424 organization and may not be made at times or places that would
425 unreasonably interfere with opportunities for the public to use
426 such facilities for established purposes. Any moneys received
427 from rentals of facilities and properties managed by the Office
428 of Drug Control and the department may be held by the Office of
429 Drug Control or in a separate depository account in the name of
430 the direct-support organization and subject to the provisions of
431 the letter of agreement with the Office of Drug Control. The
432 letter of agreement must provide that any funds held in the
433 separate depository account in the name of the direct-support
434 organization must revert to the Office of Drug Control if the
435 direct-support organization is no longer approved by the Office
436 of Drug Control to operate in the best interests of the state.
437 (g) The Office of Drug Control, in consultation with the
438 department, may adopt rules under s. 120.54 to govern the use of
439 administrative services, property, or facilities of the
440 department or office by the direct-support organization.
441 (h) The Office of Drug Control may not permit the use of
442 any administrative services, property, or facilities of the
443 state by a direct-support organization if that organization does
444 not provide equal membership and employment opportunities to all
445 persons regardless of race, color, religion, gender, age, or
446 national origin.
447 (i) The direct-support organization shall provide for an
448 independent annual financial audit in accordance with s.
449 215.981. Copies of the audit shall be provided to the Office of
450 Drug Control and the Office of Policy and Budget in the
451 Executive Office of the Governor.
452 (j) The direct-support organization may not exercise any
453 power under s. 617.0302(12) or (16).
454 (12) A prescriber or dispenser may have access to the
455 information under this section which relates to a patient of
456 that prescriber or dispenser as needed for the purpose of
457 reviewing the patient’s controlled drug prescription history. A
458 prescriber or dispenser acting in good faith is immune from any
459 civil, criminal, or administrative liability that might
460 otherwise be incurred or imposed for receiving or using
461 information from the prescription drug monitoring program. This
462 subsection does not create a private cause of action, and a
463 person may not recover damages against a prescriber or dispenser
464 authorized to access information under this subsection for
465 accessing or failing to access such information.
466 (13) To the extent that funding is provided for such
467 purpose through federal or private grants or gifts and other
468 types of available moneys, the department, in collaboration with
469 the Office of Drug Control, shall study the feasibility of
470 enhancing the prescription drug monitoring program for the
471 purposes of public health initiatives and statistical reporting
472 that respects the privacy of the patient, the prescriber, and
473 the dispenser. Such a study shall be conducted in order to
474 further improve the quality of health care services and safety
475 by improving the prescribing and dispensing practices for
476 prescription drugs, taking advantage of advances in technology,
477 reducing duplicative prescriptions and the overprescribing of
478 prescription drugs, and reducing drug abuse. The requirements of
479 the National All Schedules Prescription Electronic Reporting
480 (NASPER) Act are authorized in order to apply for federal NASPER
481 funding. In addition, the direct-support organization shall
482 provide funding for the department, in collaboration with the
483 Office of Drug Control, to conduct training for health care
484 practitioners and other appropriate persons in using the
485 monitoring program to support the program enhancements.
486 (14) A pharmacist, pharmacy, or dispensing health care
487 practitioner or his or her agent, before releasing a controlled
488 substance to any person not known to such dispenser, shall
489 require the person purchasing, receiving, or otherwise acquiring
490 the controlled substance to present valid photographic
491 identification or other verification of his or her identity to
492 the dispenser. If the person does not have proper
493 identification, the dispenser may verify the validity of the
494 prescription and the identity of the patient with the prescriber
495 or his or her authorized agent. Verification of health plan
496 eligibility through a real-time inquiry or adjudication system
497 will be considered to be proper identification. This subsection
498 does not apply in an institutional setting or to a long-term
499 care facility, including, but not limited to, an assisted living
500 facility or a hospital to which patients are admitted. As used
501 in this subsection, the term “proper identification” means an
502 identification that is issued by a state or the Federal
503 Government containing the person’s photograph, printed name, and
504 signature or a document considered acceptable under 8 C.F.R.
505 274a.2(b)(1)(v)(A) and (B).
506 (15) The Agency for Health Care Administration shall
507 continue the promotion of electronic prescribing by health care
508 practitioners, health care facilities, and pharmacies under s.
509 408.0611.
510 (16) By October 1, 2010, the department shall adopt rules
511 pursuant to ss. 120.536(1) and 120.54 to administer the
512 provisions of this section, which shall include as necessary the
513 reporting, accessing, evaluation, management, development,
514 implementation, operation, and storage of information within the
515 monitoring program’s system.
516 Section 2. (1) The Program Implementation and Oversight
517 Task Force is created within the Executive Office of the
518 Governor. The director of the Office of Drug Control shall be a
519 nonvoting, ex officio member of the task force and shall act as
520 chair. The Office of Drug Control and the Department of Health
521 shall provide staff support for the task force.
522 (a) The following state officials shall serve on the task
523 force:
524 1. The Attorney General or his or her designee.
525 2. The Secretary of Children and Family Services or his or
526 her designee.
527 3. The Secretary of Health Care Administration or his or
528 her designee.
529 4. The State Surgeon General or his or her designee.
530 (b) In addition, the Governor shall appoint 12 members of
531 the public to serve on the task force. Of these 12 appointed
532 members, one member must have professional or occupational
533 expertise in computer security; one member must be a Florida
534 licensed, board-certified oncologist; two members must be
535 Florida-licensed, fellowship-trained, pain-medicine physicians;
536 one member must be a Florida-licensed primary care physician who
537 has experience in prescribing scheduled prescription drugs; one
538 member must have professional or occupational expertise in e
539 Prescribing or prescription drug monitoring programs; two
540 members must be a Florida-licensed pharmacists; one member must
541 have professional or occupational expertise in the area of law
542 enforcement and have experience in prescription drug
543 investigations; one member must have professional or
544 occupational expertise as an epidemiologist and have a
545 background in tracking and analyzing drug trends; and two
546 members must have professional or occupational expertise as
547 providers of substance abuse treatment, with priority given to a
548 member who is a former substance abuser.
549 (c) Members appointed by the Governor shall be appointed to
550 a term of 3 years each. Any vacancy on the task force shall be
551 filled in the same manner as the original appointment, and any
552 member appointed to fill a vacancy shall serve only for the
553 unexpired term of the member’s predecessor.
554 (d) Members of the task force and members of subcommittees
555 appointed under subsection (4) shall serve without compensation,
556 but are entitled to reimbursement for per diem and travel
557 expenses as provided in s. 112.061, Florida Statutes.
558 (e) The task force shall meet at least quarterly or upon
559 the call of the chair.
560 (2) The purpose of the task force is to monitor the
561 implementation and safeguarding of the electronic system
562 established for the prescription drug monitoring program under
563 s. 893.055, Florida Statutes, and to ensure privacy, protection
564 of individual medication history, and the electronic system’s
565 appropriate use by physicians, dispensers, pharmacies, law
566 enforcement agencies, and those authorized to request
567 information from the electronic system.
568 (3) The Office of Drug Control shall submit a report to the
569 Governor, the President of the Senate, and the Speaker of the
570 House of Representatives by December 1 of each year which
571 contains a summary of the work of the task force during that
572 year and the recommendations developed in accordance with the
573 task force’s purpose as provided in subsection (2). Interim
574 reports may be submitted at the discretion of the chair.
575 (4) The chair of the task force may appoint subcommittees
576 that include members of state agencies that are not represented
577 on the task force for the purpose of soliciting input and
578 recommendations from those state agencies as needed by the task
579 force to accomplish its purpose as provided in subsection (2).
580 In addition, the chair may appoint subcommittees as necessary
581 from among the members of the task force in order to efficiently
582 address specific issues. If a state agency is to be represented
583 on any subcommittee, the representative shall be the head of the
584 agency or his or her designee. The chair may designate lead and
585 contributing agencies within a subcommittee.
586 (5) The direct-support organization created in s. 895.055,
587 Florida Statutes, may collect, expend, and provide funds and
588 other assistance to the department for the development,
589 implementation, and operation of the task force.
590 (6) The task force shall provide a final report in
591 accordance with the task force’s purpose as provided in
592 subsection (2) on July 1, 2012, to the Governor, the President
593 of the Senate, and the Speaker of the House of Representatives.
594 Such report shall be prepared using only data that does not
595 identify a patient, a prescriber, or a dispenser. The task force
596 shall expire and this section is repealed on that date unless
597 reenacted by the Legislature.
598 Section 3. Subsections (4) and (5) are added to section
599 458.309, Florida Statutes, to read:
600 458.309 Rulemaking authority.—
601 (4) All privately owned pain-management clinics,
602 facilities, or offices, hereinafter referred to as “clinics,”
603 which advertise in any medium for any type of pain-management
604 services, or employ a physician who is primarily engaged in the
605 treatment of pain by prescribing or dispensing controlled
606 substance medications, must register with the department by
607 January 4, 2010, unless that clinic is licensed as a facility
608 pursuant to chapter 395. A physician may not practice medicine
609 in a pain-management clinic that is required to but has not
610 registered with the department. Each clinic location shall be
611 registered separately regardless of whether the clinic is
612 operated under the same business name or management as another
613 clinic. If the clinic is licensed as a health care clinic under
614 chapter 400, the medical director is responsible for registering
615 the facility with the department. If the clinic is not
616 registered pursuant to chapter 395 or chapter 400, the clinic
617 shall, upon registration with the department, designate a
618 physician who is responsible for complying with all requirements
619 related to registration of the clinic. The designated physician
620 shall be licensed under this chapter or chapter 459 and shall
621 practice at the office location for which the physician has
622 assumed responsibility. The department shall inspect the clinic
623 annually to ensure that it complies with rules of the Board of
624 Medicine adopted pursuant to this subsection and subsection (5)
625 unless the office is accredited by a nationally recognized
626 accrediting agency approved by the Board of Medicine. The actual
627 costs for registration and inspection or accreditation shall be
628 paid by the physician seeking to register the clinic.
629 (5) The Board of Medicine shall adopt rules setting forth
630 standards of practice for physicians practicing in privately
631 owned pain-management clinics that primarily engage in the
632 treatment of pain by prescribing or dispensing controlled
633 substance medications. Such rules shall address, but need not be
634 limited to, the following subjects:
635 (a) Facility operations;
636 (b) Physical operations;
637 (c) Infection control requirements;
638 (d) Health and safety requirements;
639 (e) Quality assurance requirements;
640 (f) Patient records;
641 (g) Training requirements for all facility health care
642 practitioners who are not regulated by another board;
643 (h) Inspections; and
644 (i) Data collection and reporting requirements.
645
646 A physician is primarily engaged in the treatment of pain by
647 prescribing or dispensing controlled substance medications when
648 the majority of the patients seen are prescribed or dispensed
649 controlled substance medications for the treatment of chronic
650 nonmalignant pain. Chronic nonmalignant pain is pain unrelated
651 to cancer which persists beyond the usual course of the disease
652 or the injury that is the cause of the pain or more than 90 days
653 after surgery.
654 Section 4. Subsections (3) and (4) are added to section
655 459.005, Florida Statutes, to read:
656 459.005 Rulemaking authority.—
657 (3) All privately owned pain-management clinics,
658 facilities, or offices, hereinafter referred to as “clinics,”
659 which advertise in any medium for any type of pain-management
660 services, or employ a physician who is licensed under this
661 chapter and who is primarily engaged in the treatment of pain by
662 prescribing or dispensing controlled substance medications, must
663 register with the department by January 4, 2010, unless that
664 clinic is licensed as a facility under chapter 395. A physician
665 may not practice osteopathic medicine in a pain-management
666 clinic that is required to but has not registered with the
667 department. Each clinic location shall be registered separately
668 regardless of whether the clinic is operated under the same
669 business name or management as another clinic. If the clinic is
670 licensed as a health care clinic under chapter 400, the medical
671 director is responsible for registering the facility with the
672 department. If the clinic is not registered under chapter 395 or
673 chapter 400, the clinic shall, upon registration with the
674 department, designate a physician who is responsible for
675 complying with all requirements related to registration of the
676 clinic. The designated physician shall be licensed under chapter
677 458 or this chapter and shall practice at the office location
678 for which the physician has assumed responsibility. The
679 department shall inspect the clinic annually to ensure that it
680 complies with rules of the Board of Osteopathic Medicine adopted
681 pursuant to this subsection and subsection (4) unless the office
682 is accredited by a nationally recognized accrediting agency
683 approved by the Board of Osteopathic Medicine. The actual costs
684 for registration and inspection or accreditation shall be paid
685 by the physician seeking to register the clinic.
686 (4) The Board of Osteopathic Medicine shall adopt rules
687 setting forth standards of practice for physicians who practice
688 in privately owned pain-management clinics that primarily engage
689 in the treatment of pain by prescribing or dispensing controlled
690 substance medications. Such rules shall address, but need not be
691 limited to, the following subjects:
692 (a) Facility operations;
693 (b) Physical operations;
694 (c) Infection control requirements;
695 (d) Health and safety requirements;
696 (e) Quality assurance requirements;
697 (f) Patient records;
698 (g) Training requirements for all facility health care
699 practitioners who are not regulated by another board;
700 (h) Inspections; and
701 (i) Data collection and reporting requirements.
702
703 A physician is primarily engaged in the treatment of pain by
704 prescribing or dispensing controlled substance medications when
705 the majority of the patients seen are prescribed or dispensed
706 controlled substance medications for the treatment of chronic
707 nonmalignant pain. Chronic nonmalignant pain is pain unrelated
708 to cancer which persists beyond the usual course of the disease
709 or the injury that is the cause of the pain or more than 90 days
710 after surgery.
711 Section 5. This act shall take effect July 1, 2009.
712
713
714 ================= T I T L E A M E N D M E N T ================
715 And the title is amended as follows:
716 Delete everything before the enacting clause
717 and insert:
718 A bill to be entitled
719 An act relating to prescription drugs; creating s.
720 893.055, F.S.; providing definitions; requiring the
721 Department of Health to establish a comprehensive
722 electronic database system to monitor the prescribing
723 and dispensing of certain controlled substances;
724 requiring specified prescribing and dispensing
725 information to be reported to the electronic database
726 system; requiring the department to establish policies
727 and procedures for the system; requiring the
728 department, in conjunction with the Office of Drug
729 Control and specified organizations, to adopt by rules
730 appropriate for the prescription drug monitoring
731 program; providing reporting requirements; providing a
732 reporting period; providing exemptions from
733 participation in the system; authorizing the
734 department to establish when to suspend and when to
735 resume reporting requirements during declared
736 emergencies; requiring all nonexempt, dispensing
737 pharmacists and practitioners to submit information in
738 a specified format; providing that the cost to the
739 dispenser in submitting the required information may
740 not be material or extraordinary; specifying costs
741 that are not material or extraordinary; providing
742 access to information reported to the system under
743 certain circumstances; providing that information in
744 the database for the electronic prescription drug
745 monitoring system is not discoverable or admissible in
746 any civil or administrative action; providing
747 exceptions; providing for the use of data for
748 specified purposes; providing requirements for
749 verification of information requested; requiring data
750 transmission to comply with state and federal privacy
751 and security laws; authorizing an agency or person to
752 maintain the data for a specified period if the data
753 is pertinent to active health care or law enforcement
754 investigation or prosecution; requiring the annual
755 reporting of certain performance measures to the
756 Governor and Legislature; providing performance
757 measure criteria; providing criminal penalties for
758 violations; requiring that all costs incurred by the
759 department for the program be funded through federal
760 grants or available private funding sources; providing
761 requirements for seeking funding and procuring goods
762 or services; authorizing the Office of Drug Control,
763 in coordination with the department, to establish a
764 direct-support organization; providing a definition;
765 providing for a board of directors appointed by the
766 director of the office; requiring the director to
767 provide guidance to the board regarding acceptance of
768 moneys from appropriate sources; requiring the direct
769 support organization to operate under written contract
770 with the office; providing contract requirements;
771 providing requirements for the direct-support
772 organization’s collecting, expending, and providing of
773 funds; requiring department approval of activities of
774 the direct-support organization; authorizing the
775 office to adopt rules for the use of certain
776 facilities and services; providing for audits;
777 prohibiting the direct-support organization from
778 exercising certain powers; establishing that a
779 prescriber or dispenser is not liable for good faith
780 use of the department-provided controlled substance
781 prescription information of a patient; requiring the
782 department, in collaboration with the office, to study
783 the feasibility of enhancing the prescription drug
784 monitoring program for specified purposes to the
785 extent that funding is provided for such purpose;
786 requiring certain persons to present specified
787 identification in order to obtain controlled
788 substances; providing for recordkeeping for certain
789 transactions; requiring the Agency for Health Care
790 Administration to continue the promotion of electronic
791 prescribing and an electronic prescribing
792 clearinghouse; requiring the department to adopt
793 rules; establishing a Program Implementation and
794 Oversight Task Force; providing for membership;
795 providing for reimbursement of certain member
796 expenses; providing for meetings; providing the
797 purpose of the task force; requiring reports to the
798 Governor and Legislature; providing for the creation,
799 membership, and duties of subcommittees; authorizing
800 the direct-support organization to collect, expend,
801 and provide funds and other assistance to the
802 department; providing for a final report and the
803 termination of the task force; amending ss. 458.309
804 and 459.005, F.S.; requiring certain physicians who
805 engage in pain management to register their clinics
806 with the department by a specified date; prohibiting
807 certain physicians from practicing in a pain
808 management clinic that has not registered with the
809 department; requiring the department to inspect each
810 facility; providing for exceptions; requiring the
811 physician seeking to register the clinic to pay the
812 costs of registration and inspection or accreditation;
813 requiring the Board of Medicine and the Board of
814 Osteopathic Medicine to adopt rules setting forth
815 standards of practice for certain physicians who
816 engage in pain management; providing criteria for the
817 rules; providing an effective date.
818
819 WHEREAS, as has been advocated by numerous pain management
820 experts, addiction medicine experts, pharmacists, and law
821 enforcement personnel, a prescription drug monitoring program
822 that provides for reporting and advisory information and other
823 specified information is established pursuant to this act to
824 serve as a means to promote the public health and welfare and to
825 detect and prevent controlled substance abuse and diversion, and
826 WHEREAS, while the importance and necessity of the proper
827 prescribing, dispensing, and monitoring of controlled
828 substances, particularly pain medication, have been established,
829 controlled prescription drugs are too often diverted in this
830 state, often through fraudulent means, including outright theft,
831 phony pharmacy fronts, loose Internet medical evaluations, and
832 inappropriate importation; in addition, there is a criminal
833 element that facilitates the prescription drug abuse epidemic
834 through illegal profitmaking from the diversion of certain
835 controlled substances that are prescribed or dispensed by
836 physicians, health care practitioners, and pharmacists, and
837 WHEREAS, in 2007, 8,620 drug-related deaths occurred in
838 this state, 3,159 of which were caused by prescription drugs, an
839 average of nearly 9 Floridians dying each day from prescription
840 drugs; Schedule IV benzodiazepines, such as Xanax and Valium,
841 were found to be present in more drug-related deaths than
842 cocaine; and opiate pain medications were found to be
843 contributing to the increasing numbers of drug-related deaths,
844 and
845 WHEREAS, pharmaceutical drug diversion hurts this state
846 significantly in terms of lost lives, increased crime, human
847 misery from addiction, and ballooning health care costs
848 connected to treatment, medical expenses, and Medicaid fraud
849 that all Floridians ultimately bear, and
850 WHEREAS, the intent of this act is not to interfere with
851 the legitimate medical use of controlled substances; however,
852 the people of this state are in need of and will benefit from a
853 secure and privacy-protected statewide electronic system of
854 specified prescription drug medication information created
855 primarily to encourage safer controlled substance prescription
856 decisions that reduce the number of prescription drug overdoses
857 and the number of drug overdose deaths; to educate and inform
858 health care practitioners and provide an added tool in patient
859 care, including appropriate treatment for patients who have
860 become addicted; to guide public health initiatives to educate
861 the population on the dangers of misusing prescription drugs; to
862 prevent the abuse or diversion of prescribed controlled
863 substances; and to ensure that those who need prescribed
864 controlled substances receive them in a manner that protects
865 patient confidentiality, and
866 WHEREAS, while certain medicines are very helpful if
867 properly prescribed to a patient in need and then used as
868 prescribed, they may be dangerous or even deadly if improperly
869 dispensed, misused, or diverted, and
870 WHEREAS, it is the intent of the Legislature to encourage
871 patient safety, responsible pain management, and proper access
872 to useful prescription drugs that are prescribed by a
873 knowledgeable, properly licensed health care practitioner who
874 dispenses prescription drugs and that are dispensed by a
875 pharmacist who is made aware of the patient’s prescription drug
876 medication history, thus preventing, in some cases, an abuse or
877 addiction problem from developing or worsening, making such a
878 problem possible or easier to identify, and facilitating the
879 order of appropriate medical treatment or referral, and
880 WHEREAS, such an electronic system will also aid
881 administrative and law enforcement agencies in an active
882 controlled substance-related investigation and will allow
883 decisions and recommendations for pursuing appropriate
884 administrative or criminal actions while maintaining such
885 information for any such investigation with a reasonable, good
886 faith anticipation of securing an arrest or prosecution in the
887 foreseeable future, and
888 WHEREAS, a Program Implementation and Oversight Task Force
889 will provide information to the Governor and Legislature
890 regarding the implementation of the program and ensure that
891 privacy and confidentiality of the patient’s prescription
892 history is respected, NOW, THEREFORE,