Florida Senate - 2009 COMMITTEE AMENDMENT
Bill No. CS for CS for SB 462
Barcode 229192
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
03/31/2009 .
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The Committee on Governmental Oversight and Accountability
(Jones) recommended the following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 893.055 Prescription drug monitoring program.—
6 (1) As used in this section, the term:
7 (a) “Advisory report” means information provided by the
8 department in writing, or as determined by the department, to a
9 prescriber, dispenser, pharmacy, or patient concerning the
10 dispensing of controlled substances. All advisory reports are
11 for informational purposes only and impose no obligations of any
12 nature or any legal duty on a prescriber, dispenser, pharmacy,
13 or patient. The advisory reports issued by the department are
14 not subject to discovery or introduction into evidence in any
15 civil or administrative action against a prescriber, dispenser,
16 pharmacy, or patient arising out of matters that are the subject
17 of the report, and a person who participates in preparing,
18 reviewing, issuing, or other activity related to an advisory
19 report may not be permitted or required to testify in any such
20 civil action as to any findings, recommendations, evaluations,
21 opinions, or other actions taken in connection with preparing,
22 reviewing, or issuing such a report.
23 (b) “Controlled substance” means a controlled substance
24 listed in Schedule II, Schedule III, or Schedule IV in s.
25 893.03.
26 (c) “Dispenser” means a dispensing pharmacist or dispensing
27 health care practitioner.
28 (d) “Health care practitioner” or “practitioner” means any
29 practitioner who is subject to licensure or regulation by the
30 department under chapter 458, chapter 459, chapter 461, chapter
31 462, chapter 464, chapter 465, or chapter 466.
32 (e) “Health care regulatory board” means any board for a
33 practitioner or health care practitioner who is licensed or
34 regulated by the department.
35 (f) “Pharmacy” means any pharmacy that is subject to
36 licensure or regulation by the department under chapter 465 and
37 that dispenses or delivers a controlled substance to an
38 individual or address in this state.
39 (g) “Prescriber” means a prescribing physician, prescribing
40 practitioner, or other prescribing health care practitioner.
41 (2)(a) By December 1, 2010, the department shall design and
42 establish a comprehensive electronic database system that has
43 controlled substance prescriptions provided to it and that
44 provides prescription information to a patient’s health care
45 practitioner and pharmacist who inform the department that they
46 wish the patient advisory report provided to them. Otherwise,
47 the patient advisory report will not be sent to the
48 practitioner, pharmacy, or pharmacist. The system shall be
49 designed to provide information regarding dispensed
50 prescriptions of controlled substances and shall not infringe
51 upon the legitimate prescribing or dispensing of a controlled
52 substance by a prescriber or dispenser acting in good faith and
53 in the course of professional practice. The system shall be
54 consistent with standards of the American Society for Automation
55 in Pharmacy (ASAP). The electronic system shall also comply with
56 the Health Insurance Portability and Accountability Act (HIPAA)
57 as it pertains to protected health information (PHI), electronic
58 protected health information (EPHI), and all other relevant
59 state and federal privacy and security laws and regulations. The
60 reporting of prescribed controlled substances shall include a
61 dispensing transaction with a dispenser pursuant to chapter 465
62 or through a dispensing transaction with a pharmacy that is not
63 located in this state but who is otherwise subject to the
64 jurisdiction of this state as to that dispensing transaction.
65 The reporting of patient advisories only refers to reports to
66 pharmacists and practitioners. Separate reports that have
67 patient prescription history information that are not patient
68 advisory reports are provided to persons and entities as
69 authorized in paragraphs (7)(b) and (c) and s. 893.0551.
70 (b) The department shall adopt rules as necessary
71 concerning the reporting, accessing, evaluation, management,
72 development, implementation, operation, and storage of
73 information within the system, including rules for when patient
74 advisory reports and patient information is provided to
75 pharmacies, prescribers, and health care practitioners and rules
76 for when health care regulatory boards, law enforcement
77 agencies, and other persons or organizations authorized in this
78 section and s. 893.0551 are provided patient prescription
79 history information from the database unless provision of such
80 information is otherwise described in this section. Such rules
81 shall be developed with a reasonable-person standard for
82 controlled prescription drug dispensers, prescribers, and
83 patients. The department shall work with the professional health
84 care licensure boards, such as the Board of Medicine and the
85 Board of Pharmacy; other appropriate organizations, such as the
86 Florida Pharmacy Association and the Florida Medical
87 Association, including those relating to pain management; and
88 the Attorney General, the Department of Law Enforcement, and the
89 Agency for Health Care Administration, to develop the
90 reasonable-person standard for rules appropriate for the
91 prescription drug monitoring program.
92 (c) All dispensers and prescribers subject to these
93 reporting requirements shall be notified by the department of
94 the implementation date for such reporting requirements.
95 (3) The pharmacy dispensing the controlled substance and
96 each prescriber who directly dispenses a controlled substance
97 shall submit to the electronic system, by a procedure and in a
98 format established by the department and consistent with an
99 ASAP-approved format, the following information for inclusion in
100 the database:
101 (a) The name of the prescribing practitioner, the
102 practitioner’s federal Drug Enforcement Administration
103 registration number, the practitioner’s National Provider
104 Identification (NPI) or other appropriate identifier, and the
105 date of the prescription.
106 (b) The date the prescription was filled and the method of
107 payment, such as cash by an individual or insurance through a
108 third party. This paragraph does not authorize the department to
109 include individual credit card or other account numbers in the
110 database.
111 (c) The full name, address, and date of birth of the person
112 for whom the prescription was written.
113 (d) The name, national drug code, quantity, and strength of
114 the controlled substance dispensed.
115 (e) The full name and address of the pharmacy or other
116 location from which the controlled substance was dispensed.
117 (f) The name of the pharmacy or practitioner other than a
118 pharmacist, dispensing the controlled substance and the
119 practitioner’s National Provider Identification (NPI).
120 (g) Other appropriate identifying information as determined
121 by department rule.
122 (4) Each time a controlled substance is dispensed to an
123 individual, the controlled substance shall be reported to the
124 department through the system as soon thereafter as possible,
125 but not more than 15 days after the date the controlled
126 substance is dispensed unless an extension is approved by the
127 department for cause as determined by rule. A dispenser must
128 meet the reporting requirements of this section by providing the
129 required information concerning each controlled substance that
130 it dispensed in a department-approved, secure methodology and
131 format. Such approved formats may include, but are not limited
132 to, submission via the Internet, on a disc, or by use of regular
133 mail.
134 (5) The following are exempt from this section when
135 administering or dispensing a controlled substance:
136 (a) A health care practitioner administering a controlled
137 substance directly to a patient if the amount of the controlled
138 substance is adequate to treat the patient during that
139 particular treatment session.
140 (b) A pharmacist or health care practitioner administering
141 a controlled substance to a patient or resident receiving care
142 as a patient at a hospital, nursing home, ambulatory surgical
143 center, hospice, or intermediate care facility for the
144 developmentally disabled which is licensed in this state.
145 (c) A practitioner administering a controlled substance in
146 the health care system of the Department of Corrections.
147 (d) A practitioner administering a controlled substance in
148 the emergency room of a licensed hospital.
149 (e) A health care practitioner administering or dispensing
150 a controlled substance to a person under the age of 16.
151 (f) A pharmacist or a dispensing practitioner dispensing a
152 one-time, 72-hour emergency resupply of a controlled substance
153 to a patient.
154 (6) The department may establish when to suspend and when
155 to resume reporting information during a state-declared or
156 nationally declared disaster.
157 (7)(a) A practitioner or pharmacist who dispenses a
158 controlled substance must submit the information required by
159 this section in an electronic or other method in an ASAP format
160 approved by rule of the department unless otherwise provided in
161 this section. The cost to the dispenser in submitting the
162 information required by this section may not be material or
163 extraordinary. Costs not considered to be material or
164 extraordinary include, but are not limited to, regular postage,
165 electronic media, regular electronic mail, and facsimile
166 charges.
167 (b) A pharmacy, prescriber, or dispenser shall have direct
168 access to information in the prescription drug monitoring
169 program’s database which relates to a patient of that pharmacy,
170 prescriber, or dispenser in a manner established by the
171 department as needed for the purpose of reviewing the patient’s
172 controlled substance prescription history. Other access to the
173 program’s database shall be limited to the program’s manager and
174 to the designated program and support staff, who may act only at
175 the direction of the program manager or in the absence of the
176 program manager. Access by the program manager or such
177 designated staff is for prescription drug program management
178 only or for management of the program’s database and its system
179 in support of the requirements of this section and in
180 furtherance of the prescription drug monitoring program.
181 Confidential and exempt information in the database shall be
182 released only as provided in paragraph (c) and s. 893.0551.
183 (c) The following entities shall not be allowed direct
184 access to information in the prescription drug monitoring
185 program database but may request from the program manager and,
186 when authorized by the program manager, the program manager’s
187 program and support staff, information that is confidential and
188 exempt under s. 893.0551. Prior to release, the request shall be
189 verified as authentic and authorized with the requesting
190 organization by the program manager, the program manager’s
191 program and support staff, or as determined in rules by the
192 department as being authentic and as having been authorized by
193 the requesting entity:
194 1. The department’s relevant health care regulatory boards
195 responsible for the licensure, regulation, or discipline of
196 practitioners, pharmacists, or other persons who are authorized
197 to prescribe, administer, or dispense controlled substances and
198 who are involved in a specific controlled substance
199 investigation involving a designated person for one or more
200 prescribed controlled substances.
201 2. The Attorney General for Medicaid fraud cases involving
202 prescribed controlled substances.
203 3. A law enforcement agency, as described in s.
204 893.0551(2)(c), during ongoing investigations as provided in s.
205 893.07 or during active investigations as defined in s. 119.011
206 regarding potential criminal activity, fraud, or theft regarding
207 prescribed controlled substances. The database information is
208 available only for criminal cases.
209 4. A patient or the legal guardian or designated health
210 care surrogate of an incapacitated patient as described in s.
211 893.0551 who, for the purpose of verifying the accuracy of the
212 database information, submits a written and notarized request
213 that includes the patient's full name, address, and date of
214 birth, and includes the same information if the legal guardian
215 or health care surrogate submits the request. The request shall
216 be validated by the department to verify the identity of the
217 patient and the legal guardian or health care surrogate, if the
218 patient's legal guardian or health care surrogate is the
219 requestor. Such verification is also required for any request to
220 change a patient's prescription history or other information
221 related to his or her information in the electronic database.
222 (d) The following entities shall not be allowed direct
223 access to information in the prescription drug monitoring
224 program database but may request from the program manager and,
225 when authorized by the program manager, the program manager’s
226 program and support staff, information that contains no
227 identifying information of any patient, physician, health care
228 practitioner, prescriber, or dispenser and that is not
229 confidential and exempt:
230 1. Department staff for the purpose of calculating
231 performance measures pursuant to subsection (8).
232 2. The Program Implementation and Oversight Task Force for
233 its reporting to the Governor, the President of the Senate, and
234 the Speaker of the House of Representatives regarding the
235 prescription drug monitoring program. This subparagraph expires
236 July 1, 2012.
237 (e) All transmissions of data required by this section must
238 comply with relevant state and federal privacy and security laws
239 and regulations. However, any authorized agency or person under
240 s. 893.0551 receiving such information as allowed by s. 893.0551
241 may maintain the information received for up to 24 months before
242 purging it from his or her records or maintain it for longer
243 than 24 months if the information is pertinent to ongoing health
244 care or an active law enforcement investigation or prosecution.
245 (8) To assist in fulfilling program responsibilities,
246 performance measures shall be reported annually to the Governor,
247 the President of the Senate, and the Speaker of the House of
248 Representatives by the department each December 1, beginning in
249 2011. Data that does not contain patient, physician, health care
250 practitioner, prescriber, or dispenser identifying information
251 may be requested during the year by department employees so that
252 the department may undertake public health care and safety
253 initiatives that take advantage of observed trends. Performance
254 measures may include, but are not limited to, efforts to achieve
255 the following outcomes:
256 (a) Reduction of the rate of inappropriate use of
257 prescription drugs through department education and safety
258 efforts.
259 (b) Reduction of the quantity of pharmaceutical controlled
260 substances obtained by individuals attempting to engage in fraud
261 and deceit.
262 (c) Increased coordination among partners participating in
263 prescription drug monitoring program.
264 (d) Involvement of stakeholders in achieving improved
265 patient health care and safety and reduction of prescription
266 drug abuse and prescription drug diversion.
267 (9) Any person who willfully and knowingly fails to report
268 the dispensing of a controlled substance as required by this
269 section commits a misdemeanor of the first degree, punishable as
270 provided in s. 775.082 or s. 775.083.
271 (10) All costs incurred by the department in administering
272 the prescription drug monitoring program shall be funded through
273 federal grants or private funding applied for or received by the
274 state. The department may not commit funds for the monitoring
275 program without ensuring funding is available. The prescription
276 drug monitoring program and the implementation thereof are
277 contingent upon receipt of the nonstate funding. The department
278 and state government shall cooperate with the direct-support
279 organization established pursuant to subsection (11) in seeking
280 federal grant funds, other nonstate grant funds, gifts,
281 donations, or other private moneys for the department so long as
282 the costs of doing so are not considered material. Nonmaterial
283 costs for this purpose include, but are not limited to, the
284 costs of mailing and personnel assigned to research or apply for
285 a grant. Notwithstanding the exemptions to competitive
286 solicitation requirements under s. 287.057(5)(f), the department
287 shall comply with the competitive-solicitation requirements
288 under s. 287.057 for the procurement of any goods or services
289 required by this section.
290 (11) The Office of Drug Control, in coordination with the
291 department, may establish a direct-support organization that has
292 a board consisting of at least five members to provide
293 assistance, funding, and promotional support for the activities
294 authorized for the prescription drug monitoring program.
295 (a) As used in this subsection, the term “direct-support
296 organization” means an organization that is:
297 1. A Florida corporation not for profit incorporated under
298 chapter 617, exempted from filing fees, and approved by the
299 Department of State.
300 2. Organized and operated to conduct programs and
301 activities; raise funds; request and receive grants, gifts, and
302 bequests of money; acquire, receive, hold, and invest, in its
303 own name, securities, funds, objects of value, or other
304 property, either real or personal; and make expenditures to or
305 for the direct or indirect benefit of the department in the
306 furtherance of the prescription drug monitoring program.
307 (b) The direct-support organization is not considered a
308 lobbying firm within the meaning of s. 11.045.
309 (c) The director of the Office of Drug Control shall
310 appoint a board of directors for the direct-support
311 organization. The director may designate employees of the Office
312 of Drug Control, state employees other than state employees from
313 the department, and any other nonstate employees as appropriate,
314 to serve on the board. Members of the board shall serve at the
315 pleasure of the director of the Office of Drug Control. The
316 director shall provide guidance to members of the board to
317 ensure that moneys received by the direct-support organization
318 are not received from inappropriate sources. Inappropriate
319 sources include, but are not limited to, donors, grantors,
320 persons, or organizations that may monetarily or substantively
321 benefit from the purchase of goods or services by the department
322 in furtherance of the prescription drug monitoring program.
323 (d) The direct-support organization shall operate under
324 written contract with the Office of Drug Control. The contract
325 must, at a minimum, provide for:
326 1. Approval of the articles of incorporation and bylaws of
327 the direct-support organization by the Office of Drug Control.
328 2. Submission of an annual budget for the approval of the
329 Office of Drug Control.
330 3. Certification by the Office of Drug Control in
331 consultation with the department that the direct-support
332 organization is complying with the terms of the contract in a
333 manner consistent with and in furtherance of the goals and
334 purposes of the prescription drug monitoring program and in the
335 best interests of the state. Such certification must be made
336 annually and reported in the official minutes of a meeting of
337 the direct-support organization.
338 4. The reversion, without penalty, to the Office of Drug
339 Control, or to the state if the Office of Drug Control ceases to
340 exist, of all moneys and property held in trust by the direct
341 support organization for the benefit of the prescription drug
342 monitoring program if the direct-support organization ceases to
343 exist or if the contract is terminated.
344 5. The fiscal year of the direct-support organization,
345 which must begin July 1 of each year and end June 30 of the
346 following year.
347 6. The disclosure of the material provisions of the
348 contract to donors of gifts, contributions, or bequests,
349 including such disclosure on all promotional and fundraising
350 publications, and an explanation to such donors of the
351 distinction between the Office of Drug Control and the direct
352 support organization.
353 7. The direct-support organization’s collecting, expending,
354 and providing of funds to the department for the development,
355 implementation, and operation of the prescription drug
356 monitoring program as described in subsections (2), (3), and
357 (4). The direct-support organization may collect and expend
358 funds to be used for the functions of the direct-support
359 organization’s board of directors, as necessary and approved by
360 the director of the Office of Drug Control. In addition, the
361 direct-support organization may collect and provide funding to
362 the department in furtherance of the prescription drug
363 monitoring program by:
364 a. Establishing and administering the prescription drug
365 monitoring program’s electronic database, including hardware,
366 software, and personnel.
367 b. Conducting studies on the efficiency and effectiveness
368 of the program.
369 c. Providing funds for future enhancements of the program
370 within the intent of this section.
371 d. Providing user training of the prescription drug
372 monitoring program, including distribution of materials to
373 promote public awareness and education and conducting workshops
374 or other meetings, for health care practitioners, pharmacists,
375 and others as appropriate.
376 e. Providing funds for travel expenses.
377 f. Providing funds for administrative costs, including
378 personnel, audits, facilities, and equipment.
379 g. Fulfilling all other requirements necessary to implement
380 and operate the program as outlined in this section.
381 (e) The activities of the direct-support organization must
382 be consistent with the goals and mission of the Office of Drug
383 Control, as determined by the office in consultation with the
384 department, and in the best interests of the state. The direct
385 support organization must obtain a written approval from the
386 director of the Office of Drug Control for any activities in
387 support of the prescription drug monitoring program before
388 undertaking those activities.
389 (f) The Office of Drug Control, in consultation with the
390 department, may permit, without charge, appropriate use of
391 administrative services, property, and facilities of the Office
392 of Drug Control and the department by the direct-support
393 organization, subject to this section. The use must be directly
394 in keeping with the approved purposes of the direct-support
395 organization and may not be made at times or places that would
396 unreasonably interfere with opportunities for the public to use
397 such facilities for established purposes. Any moneys received
398 from rentals of facilities and properties managed by the Office
399 of Drug Control and the department may be held by the Office of
400 Drug Control or in a separate depository account in the name of
401 the direct-support organization and subject to the provisions of
402 the letter of agreement with the Office of Drug Control. The
403 letter of agreement must provide that any funds held in the
404 separate depository account in the name of the direct-support
405 organization must revert to the Office of Drug Control if the
406 direct-support organization is no longer approved by the Office
407 of Drug Control to operate in the best interests of the state.
408 (g) The Office of Drug Control, in consultation with the
409 department, may adopt rules under s. 120.54 to govern the use of
410 administrative services, property, or facilities of the
411 department or office by the direct-support organization.
412 (h) The Office of Drug Control may not permit the use of
413 any administrative services, property, or facilities of the
414 state by a direct-support organization if that organization does
415 not provide equal membership and employment opportunities to all
416 persons regardless of race, color, religion, gender, age, or
417 national origin.
418 (i) The direct-support organization shall provide for an
419 independent annual financial audit in accordance with s.
420 215.981. Copies of the audit shall be provided to the Office of
421 Drug Control and the Office of Policy and Budget in the
422 Executive Office of the Governor.
423 (j) The direct-support organization may not exercise any
424 power under s. 617.0302(12) or (16).
425 (12) A prescriber or dispenser may have access to the
426 information under this section which relates to a patient of
427 that prescriber or dispenser as needed for the purpose of
428 reviewing the patient’s controlled drug prescription history. A
429 prescriber or dispenser acting in good faith is immune from any
430 civil, criminal, or administrative liability that might
431 otherwise be incurred or imposed for receiving or using
432 information from the prescription drug monitoring program. This
433 subsection does not create a private cause of action, and a
434 person may not recover damages against a prescriber or dispenser
435 authorized to access information under this subsection for
436 accessing or failing to access such information.
437 (13) To the extent that funding is provided for such
438 purpose through federal or private grants or gifts and other
439 types of available moneys, the department, in collaboration with
440 the Office of Drug Control, shall study the feasibility of
441 enhancing the prescription drug monitoring program for the
442 purposes of public health initiatives and statistical reporting
443 that respects the privacy of the patient, the prescriber, and
444 the dispenser. Such a study shall be conducted in order to
445 further improve the quality of health care services and safety
446 by improving the prescribing and dispensing practices for
447 prescription drugs, taking advantage of advances in technology,
448 reducing duplicative prescriptions and the overprescribing of
449 prescription drugs, and reducing drug abuse. In addition, the
450 direct-support organization shall provide funding for the
451 department, in collaboration with the Office of Drug Control, to
452 conduct training for health care practitioners and other
453 appropriate persons in using the monitoring program to support
454 the program enhancements.
455 (14) A pharmacist, pharmacy, or dispensing health care
456 practitioner or his or her agent, before releasing a controlled
457 substance to any person not known to such dispenser, shall
458 require the person purchasing, receiving, or otherwise acquiring
459 the controlled substance to present valid photographic
460 identification or other verification of his or her identity to
461 the dispenser. If the person does not have proper
462 identification, the dispenser may verify the validity of the
463 prescription and the identity of the patient with the prescriber
464 or his or her authorized agent. This subsection does not apply
465 in an institutional setting or to a long-term care facility,
466 including, but not limited to, an assisted living facility or a
467 hospital to which patients are admitted. As used in this
468 subsection, the term “proper identification” means an
469 identification that is issued by a state or the Federal
470 Government containing the person’s photograph, printed name, and
471 signature or a document considered acceptable under 8 C.F.R.
472 274a.2(b)(1)(v)(A) and (B).
473 (15) The Agency for Health Care Administration shall
474 continue the implementation of electronic prescribing by health
475 care practitioners, health care facilities, and pharmacies under
476 s. 408.061 and the electronic prescribing clearinghouse
477 collaboration with the private sector under s. 408.0611.
478 (16) By October 1, 2010, the department shall adopt rules
479 pursuant to ss. 120.536(1) and 120.54 to administer the
480 provisions of this section.
481 Section 2. (1) The Program Implementation and Oversight
482 Task Force is created within the Executive Office of the
483 Governor. The director of the Office of Drug Control shall be a
484 nonvoting, ex officio member of the task force and shall act as
485 chair. The Office of Drug Control and the Department of Health
486 shall provide staff support for the task force.
487 (a) The following state officials shall serve on the task
488 force:
489 1. The Attorney General or his or her designee.
490 2. The Secretary of Children and Family Services or his or
491 her designee.
492 3. The Secretary of Health Care Administration or his or
493 her designee.
494 4. The State Surgeon General or his or her designee.
495 (b) In addition, the Governor shall appoint 11 members of
496 the public to serve on the task force. Of these 11 appointed
497 members, one member must have professional or occupational
498 expertise in computer security; one member must be a Florida
499 licensed, board-certified oncologist; two members must be
500 Florida-licensed, board-certified, fellowship-trained physicians
501 who have experience in pain management; one member must be a
502 Florida-licensed primary care physician who has experience in
503 prescribing scheduled prescription drugs; one member must have
504 professional or occupational expertise in e-Prescribing or
505 prescription drug monitoring programs; one member must be a
506 Florida-licensed pharmacist; one member must have professional
507 or occupational expertise in the area of law enforcement and
508 have experience in prescription drug investigations; one member
509 must have professional or occupational expertise as an
510 epidemiologist and have a background in tracking and analyzing
511 drug trends; and two members must have professional or
512 occupational expertise as providers of substance abuse
513 treatment, with priority given to a member who is a former
514 substance abuser.
515 (c) Members appointed by the Governor shall be appointed to
516 a term of 3 years each. Any vacancy on the task force shall be
517 filled in the same manner as the original appointment, and any
518 member appointed to fill a vacancy shall serve only for the
519 unexpired term of the member’s predecessor.
520 (d) Members of the task force and members of subcommittees
521 appointed under subsection (4) shall serve without compensation,
522 but are entitled to reimbursement for per diem and travel
523 expenses as provided in s. 112.061, Florida Statutes.
524 (e) The task force shall meet at least quarterly or upon
525 the call of the chair.
526 (2) The purpose of the task force is to monitor the
527 implementation and safeguarding of the electronic system
528 established for the prescription drug monitoring program under
529 s. 893.055, Florida Statutes, and to ensure privacy, protection
530 of individual medication history, and the electronic system’s
531 appropriate use by physicians, dispensers, pharmacies, law
532 enforcement agencies, and those authorized to request
533 information from the electronic system.
534 (3) The Office of Drug Control shall submit a report to the
535 Governor, the President of the Senate, and the Speaker of the
536 House of Representatives by December 1 of each year which
537 contains a summary of the work of the task force during that
538 year and the recommendations developed in accordance with the
539 task force’s purpose as provided in subsection (2). Interim
540 reports may be submitted at the discretion of the chair.
541 (4) The chair of the task force may appoint subcommittees
542 that include members of state agencies that are not represented
543 on the task force for the purpose of soliciting input and
544 recommendations from those state agencies as needed by the task
545 force to accomplish its purpose as provided in subsection (2).
546 In addition, the chair may appoint subcommittees as necessary
547 from among the members of the task force in order to efficiently
548 address specific issues. If a state agency is to be represented
549 on any subcommittee, the representative shall be the head of the
550 agency or his or her designee. The chair may designate lead and
551 contributing agencies within a subcommittee.
552 (5) The task force shall provide a final report in
553 accordance with the task force’s purpose as provided in
554 subsection (2) on July 1, 2012, to the Governor, the President
555 of the Senate, and the Speaker of the House of Representatives.
556 Such report shall be prepared using only data that does not
557 identify a patient, a prescriber, or a dispenser. The task force
558 shall expire and this section is repealed on that date unless
559 reenacted by the Legislature.
560 Section 3. Subsections (4) and (5) are added to section
561 458.309, Florida Statutes, to read:
562 458.309 Rulemaking authority.—
563 (4) Each privately owned pain-management clinic that
564 employs a physician licensed under this chapter and who is
565 primarily engaged in the treatment of pain by prescribing
566 controlled substance medications must be registered with the
567 department unless that clinic is licensed as a facility under
568 chapter 395. Each clinic location shall be licensed separately
569 regardless of whether the clinic is operated under the same
570 business name or management as another clinic. If the clinic is
571 licensed as a health care clinic under chapter 400, the medical
572 director shall be responsible for registering the facility with
573 the department. If the clinic is not licensed under chapter 395
574 or chapter 400, the clinic shall, upon registration with the
575 department, designate a physician who is responsible for
576 complying with all requirements related to registration of the
577 clinic. The designated physician shall be licensed under this
578 chapter or chapter 459 and shall practice at the office location
579 for which the physician has assumed responsibility. The
580 department shall inspect the clinic annually to ensure that it
581 complies with board rules adopted pursuant to this subsection
582 and subsection (5) unless the clinic is accredited by a
583 nationally recognized accrediting agency approved by the board.
584 The actual costs for registration and inspection or
585 accreditation shall be paid by the physician seeking to register
586 the clinic.
587 (5) The board shall adopt rules setting forth standards of
588 practice for physicians who practice in privately owned pain
589 management clinics that primarily engage in the treatment of
590 pain by prescribing controlled substance medications. Such rules
591 shall address, but need not be limited to, the following
592 subjects:
593 (a) Facility operations;
594 (b) Physical operations;
595 (c) Infection control requirements;
596 (d) Health and safety requirements;
597 (e) Quality assurance requirements;
598 (f) Patient records;
599 (g) Training requirements for all facility health care
600 practitioners;
601 (h) Inspections; and
602 (i) Data collection and reporting requirements.
603
604 A physician is primarily engaged in the treatment of pain by
605 prescribing controlled substance medications if the majority of
606 the patients seen on any day the facility is open are issued
607 controlled substance medications for the treatment of chronic
608 nonmalignant pain. Chronic nonmalignant pain is pain unrelated
609 to cancer which persists beyond the usual course of disease or
610 injury. It may or may not be associated with a pathologic
611 disease.
612 Section 4. Subsections (3) and (4) are added to section
613 459.005, Florida Statutes, to read:
614 459.005 Rulemaking authority.—
615 (3) Each privately owned pain-management clinic that
616 employs a physician licensed under this chapter and who is
617 primarily engaged in the treatment of pain by prescribing
618 controlled substance medications must be registered with the
619 department unless that clinic is licensed as a facility under
620 chapter 395. Each clinic location shall be licensed separately
621 regardless of whether the clinic is operated under the same
622 business name or management as another clinic. If the clinic is
623 licensed as a health care clinic under chapter 400, the medical
624 director shall be responsible for registering the facility with
625 the department. If the clinic is not licensed under chapter 395
626 or chapter 400, the clinic shall, upon registration with the
627 department, designate a physician who is responsible for
628 complying with all requirements related to registration of the
629 clinic. The designated physician shall be licensed under chapter
630 458 or this chapter and shall practice at the office location
631 for which the physician has assumed responsibility. The
632 department shall inspect the clinic annually to ensure that it
633 complies with board rules adopted pursuant to this subsection
634 and subsection (4) unless the clinic is accredited by a
635 nationally recognized accrediting agency approved by the board.
636 The actual costs for registration and inspection or
637 accreditation shall be paid by the physician seeking to register
638 the clinic.
639 (4) The board shall adopt rules setting forth standards of
640 practice for physicians who practice in privately owned pain
641 management clinics that primarily engage in the treatment of
642 pain by prescribing controlled substance medications. Such rules
643 shall address, but need not be limited to, the following
644 subjects:
645 (a) Facility operations;
646 (b) Physical operations;
647 (c) Infection control requirements;
648 (d) Health and safety requirements;
649 (e) Quality assurance requirements;
650 (f) Patient records;
651 (g) Training requirements for all facility health care
652 practitioners;
653 (h) Inspections; and
654 (i) Data collection and reporting requirements.
655
656 A physician is primarily engaged in the treatment of pain by
657 prescribing controlled substance medications if the majority of
658 the patients seen on any day the facility is open are issued
659 controlled substance medications for the treatment of chronic
660 nonmalignant pain. Chronic nonmalignant pain is pain unrelated
661 to cancer which persists beyond the usual course of disease or
662 injury. It may or may not be associated with a pathologic
663 disease.
664 Section 5. This act shall take effect July 1, 2009.
665
666 ================= T I T L E A M E N D M E N T ================
667 And the title is amended as follows:
668 Delete everything before the enacting clause
669 and insert:
670 A bill to be entitled
671 An act relating to prescription drugs; creating s.
672 893.055, F.S.; providing definitions; requiring the
673 Department of Health to establish a comprehensive
674 electronic database system to monitor the prescribing
675 and dispensing of certain controlled substances;
676 requiring specified prescribing and dispensing
677 information to be reported to the electronic database
678 system; requiring the department, in conjunction with
679 specified organizations, to adopt by rule a
680 reasonable-person standard appropriate for the
681 prescription drug monitoring program; providing
682 reporting requirements; providing a reporting period;
683 providing exemptions from participation in the system;
684 authorizing the department to establish when to
685 suspend and when to resume reporting requirements
686 during declared emergencies; requiring all nonexempt,
687 dispensing pharmacists and practitioners to submit
688 information in a specified format; providing that the
689 cost to the dispenser in submitting the required
690 information may not be material or extraordinary;
691 specifying costs that are not material or
692 extraordinary; providing access to information
693 reported to the system under certain circumstances;
694 providing for the use of data for specified purposes;
695 providing requirements for verification of information
696 requested; requiring data transmission to comply with
697 state and federal privacy and security laws;
698 authorizing an agency or person to maintain the data
699 for a specified period if the data is pertinent to
700 ongoing health care or an active law enforcement
701 investigation or prosecution; requiring the annual
702 reporting of certain performance measures to the
703 Governor and Legislature; providing performance
704 measure criteria; providing criminal penalties for
705 violations; requiring that all costs incurred by the
706 department for the program be funded through federal
707 grants or available private funding sources; providing
708 requirements for seeking funding and procuring goods
709 or services; authorizing the Office of Drug Control,
710 in coordination with the department, to establish a
711 direct-support organization; providing a definition;
712 providing for a board of directors appointed by the
713 director of the office; requiring the director to
714 provide guidance to the board regarding acceptance of
715 moneys from appropriate sources; requiring the direct
716 support organization to operate under written contract
717 with the office; providing contract requirements;
718 providing requirements for the direct-support
719 organization's collecting, expending, and providing of
720 funds; requiring department approval of activities of
721 the direct-support organization; authorizing the
722 office to adopt rules for the use of certain
723 facilities and services; providing for audits;
724 prohibiting the direct-support organization from
725 exercising certain powers; establishing that a
726 prescriber or dispenser is not liable for good faith
727 use of the department-provided controlled substance
728 prescription information of a patient; requiring the
729 department, in collaboration with the office, to study
730 the feasibility of enhancing the prescription drug
731 monitoring program for specified purposes to the
732 extent that funding is provided for such purpose;
733 requiring certain persons to present specified
734 identification in order to obtain controlled
735 substances; providing for recordkeeping for certain
736 transactions; requiring the Agency for Health Care
737 Administration to continue implementation of
738 electronic prescribing and an electronic prescribing
739 clearinghouse; requiring the department to adopt
740 rules; establishing a Program Implementation and
741 Oversight Task Force; providing for membership;
742 providing for reimbursement of certain member
743 expenses; providing for meetings; providing the
744 purpose of the task force; requiring reports to the
745 Governor and Legislature; providing for the creation,
746 membership, and duties of subcommittees; providing for
747 a final report and the termination of the task force;
748 amending ss. 458.309 and 459.005, F.S.; requiring
749 certain physicians who engage in pain management to
750 register their clinics with the department; requiring
751 the department to inspect each facility; providing for
752 exceptions; requiring the physician seeking to
753 register the clinic to pay the costs of registration
754 and inspection or accreditation; requiring the Board
755 of Medicine and the Board of Osteopathic Medicine to
756 adopt rules setting forth standards of practice for
757 certain physicians who engage in pain management;
758 providing criteria for the rules; providing an
759 effective date.
760
761 WHEREAS, as has been advocated by numerous pain management
762 experts, addiction medicine experts, pharmacists, and law
763 enforcement personnel, a prescription drug monitoring program
764 that provides for reporting and advisory information and other
765 specified information is established pursuant to this act to
766 serve as a means to promote the public health and welfare and to
767 detect and prevent controlled substance abuse and diversion, and
768 WHEREAS, while the importance and necessity of the proper
769 prescribing, dispensing, and monitoring of controlled
770 substances, particularly pain medication, have been established,
771 controlled prescription drugs are too often diverted in this
772 state, often through fraudulent means, including outright theft,
773 phony pharmacy fronts, loose Internet medical evaluations, and
774 inappropriate importation; in addition, there is a criminal
775 element that facilitates the prescription drug abuse epidemic
776 through illegal profitmaking from the diversion of certain
777 controlled substances that are prescribed or dispensed by
778 physicians, health care practitioners, and pharmacists, and
779 WHEREAS, in 2007, 8,620 drug-related deaths occurred in
780 this state, 3,159 of which were caused by prescription drugs, an
781 average of nearly 9 Floridians dying each day from prescription
782 drugs; Schedule IV benzodiazepines, such as Xanax and Valium,
783 were found to be present in more drug-related deaths than
784 cocaine; and opiate pain medications were found to be
785 contributing to the increasing numbers of drug-related deaths,
786 and
787 WHEREAS, pharmaceutical drug diversion hurts this state
788 significantly in terms of lost lives, increased crime, human
789 misery from addiction, and ballooning health care costs
790 connected to treatment, medical expenses, and Medicaid fraud
791 that all Floridians ultimately bear, and
792 WHEREAS, the intent of this act is not to interfere with
793 the legitimate medical use of controlled substances; however,
794 the people of this state are in need of and will benefit from a
795 secure and privacy-protected statewide electronic system of
796 specified prescription drug medication information created
797 primarily to encourage safer controlled substance prescription
798 decisions that reduce the number of prescription drug overdoses
799 and the number of drug overdose deaths; to educate and inform
800 health care practitioners and provide an added tool in patient
801 care, including appropriate treatment for patients who have
802 become addicted; to guide public health initiatives to educate
803 the population on the dangers of misusing prescription drugs; to
804 prevent the abuse or diversion of prescribed controlled
805 substances; and to ensure that those who need prescribed
806 controlled substances receive them in a manner that protects
807 patient confidentiality, and
808 WHEREAS, while certain medicines are very helpful if
809 properly prescribed to a patient in need and then used as
810 prescribed, they may be dangerous or even deadly if improperly
811 dispensed, misused, or diverted, and
812 WHEREAS, it is the intent of the Legislature to encourage
813 patient safety, responsible pain management, and proper access
814 to useful prescription drugs that are prescribed by a
815 knowledgeable, properly licensed health care practitioner who
816 dispenses prescription drugs and that are dispensed by a
817 pharmacist who is made aware of the patient’s prescription drug
818 medication history, thus preventing, in some cases, an abuse or
819 addiction problem from developing or worsening, making such a
820 problem possible or easier to identify, and facilitating the
821 order of appropriate medical treatment or referral, and
822 WHEREAS, such an electronic system will also aid
823 administrative and law enforcement agencies in an active and
824 ongoing controlled substance-related investigation and will
825 allow decisions and recommendations for pursuing appropriate
826 administrative or criminal actions while maintaining such
827 information for any such investigation with a reasonable, good
828 faith anticipation of securing an arrest or prosecution in the
829 foreseeable future, and
830 WHEREAS, a Program Implementation and Oversight Task Force
831 will provide information to the Governor and Legislature
832 regarding the implementation of the program and ensure that
833 privacy and confidentiality of the patient’s prescription
834 history is respected, NOW, THEREFORE,