Florida Senate - 2009 COMMITTEE AMENDMENT
Bill No. CS for SB 462
Barcode 756918
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
03/25/2009 .
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The Committee on Judiciary (Fasano) 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 validation program.—
8 (1) As used in this section, the term:
9 (a) “Advisory report” means information provided by the
10 department in writing to a prescriber, dispenser, pharmacy, or
11 patient concerning the dispensing of controlled substances. All
12 advisory reports are for informational purposes only and impose
13 no obligations of any nature or any legal duty on a prescriber,
14 dispenser, pharmacy, or patient. The advisory reports issued by
15 the department are not subject to discovery or introduction into
16 evidence in any civil or administrative action against a
17 prescriber, dispenser, pharmacy, or patient arising out of
18 matters that are the subject of the report, and a person who
19 participates in preparing an advisory report may not be
20 permitted or required to testify in any such civil action as to
21 any findings, recommendations, evaluations, opinions, or other
22 actions taken in connection with preparing 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 a patient
38 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 system that has controlled
43 substance prescriptions provided to it and that provides
44 prescription information to a patient’s health care practitioner
45 and pharmacist who inform the department that they wish the
46 patient advisory report provided to them. Otherwise, the patient
47 advisory report will not be sent to the practitioner, pharmacy,
48 or pharmacist. The system shall be designed to provide
49 information regarding dispensed prescriptions of controlled
50 substances in order to prevent the inadvertent, improper, or
51 illegal use of controlled substances and may not infringe upon
52 the legitimate prescribing or dispensing of a controlled
53 substance by a prescriber or dispenser acting in good faith and
54 in the course of professional practice. The system shall be
55 consistent with standards of the American Society for Automation
56 in Pharmacy (ASAP) for the validation of the prescribing and
57 dispensing of controlled substances to an individual. The
58 electronic system shall also comply with the Health Insurance
59 Portability and Accountability Act (HIPAA) as it pertains to
60 protected health information (PHI), electronic protected health
61 information (EPHI), and all other relevant state and federal
62 privacy and security laws and regulations. The validating of
63 prescribed controlled substances shall include a dispensing
64 transaction with a dispenser who is not located in this state
65 but who is otherwise subject to the jurisdiction of this state
66 as to that dispensing transaction. The reporting of patient
67 advisories only refers to reports to pharmacists and
68 practitioners. Separate reports that are not patient advisory
69 reports are provided to persons and entities as authorized in
70 this section and s. 893.0551.
71 (b) The department shall adopt rules as necessary
72 concerning the reporting, accessing, evaluation, management,
73 development, implementation, operation, and storage of
74 information within the system, including rules for when patient
75 advisory reports and patient information is provided to
76 pharmacies, prescribers, and health care practitioners and rules
77 for when health care regulatory boards and law enforcement
78 agencies are provided patient prescription history information
79 from the database unless provision of such information is
80 otherwise described in this section. Such rules shall be
81 developed with a reasonable-person standard for controlled
82 prescription drug dispensers, prescribers, and patients. The
83 department shall work with the professional health care
84 licensure boards, such as the Board of Medicine and the Board of
85 Pharmacy; other appropriate organizations, such as the Florida
86 Pharmacy Association and the Florida Medical Association,
87 including those relating to pain management; and the Attorney
88 General, the Department of Law Enforcement, and the Agency for
89 Health Care Administration, to develop the reasonable-person
90 standard for rules appropriate for the prescription drug
91 validation 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 ASAP
99 format, the following information for inclusion in the database:
100 (a) The name of the prescribing practitioner, the
101 practitioner’s federal Drug Enforcement Administration
102 registration number, the practitioner’s National Provider
103 Identification (NPI) or other appropriate identifier, and the
104 date of the prescription.
105 (b) The date the prescription was filled and the method of
106 payment, including cash. This paragraph does not authorize the
107 department to include individual credit card or other account
108 numbers in the database.
109 (c) The full name, address, and date of birth of the person
110 for whom the prescription was written.
111 (d) The name, national drug code, quantity, and strength of
112 the controlled substance dispensed.
113 (e) The full name and address of the pharmacy or other
114 location from which the controlled substance was dispensed.
115 (f) The full name of the pharmacist or practitioner
116 dispensing the controlled substance and the practitioner’s
117 National Provider Identification (NPI).
118 (g) Other appropriate identifying information as determined
119 by department rule.
120 (4) Each time a controlled substance is dispensed to an
121 individual, the controlled substance shall be reported to the
122 department through the system as soon thereafter as possible,
123 but not more than 15 days after the date the controlled
124 substance is dispensed. A dispenser must meet the reporting
125 requirements of this section by providing the required
126 information concerning each controlled substance that it
127 dispensed in a department-approved, secure methodology and
128 format. Such approved formats may include, but are not limited
129 to, submission via the Internet, on a disc, or by use of regular
130 mail.
131 (5) The following are exempt from this section when
132 administering a controlled substance:
133 (a) A health care practitioner administering a controlled
134 substance directly to a patient if the amount of the controlled
135 substance is adequate to treat the patient during that
136 particular treatment session.
137 (b) A pharmacist or health care practitioner administering
138 a controlled substance to a patient or resident receiving care
139 as a patient at a hospital, nursing home, ambulatory surgical
140 center, hospice, or intermediate care facility for the
141 developmentally disabled which is licensed in this state.
142 (c) A practitioner administering a controlled substance in
143 the health care system of the Department of Corrections.
144 (d) A practitioner administering a controlled substance in
145 the emergency room of a licensed hospital.
146 (e) A health care practitioner administering a controlled
147 substance to a person under the age of 16.
148 (6) The department may establish when to suspend and when
149 to resume reporting information during a state-declared or
150 nationally declared disaster.
151 (7)(a) A practitioner or pharmacist who dispenses a
152 controlled substance must submit the information required by
153 this section in an electronic or other ASAP format approved by
154 rule of the department unless otherwise provided in this
155 section. The cost to the dispenser in submitting the information
156 required by this section may not be material or extraordinary.
157 Costs not considered to be material or extraordinary include,
158 but are not limited to, regular postage, electronic media,
159 regular electronic mail, and facsimile charges.
160 (b) A pharmacy, prescriber, or dispenser may have direct
161 access to information in the prescription drug validation
162 program’s electronic system database which relates to a patient
163 of that pharmacy, prescriber, or dispenser in a manner
164 established by the department for the purpose of reviewing the
165 patient’s controlled substance prescription history to ensure a
166 proper standard of care. Other access to the program’s
167 electronic system database shall be limited to the program’s
168 manager and to designated program staff, who may act only at the
169 direction of the program manager or in the absence of the
170 program manager. Access by the program manager or such
171 designated staff is for prescription drug management only or for
172 management of the program’s database in support of the
173 requirements of this section and in furtherance of the
174 prescription drug validation program. Confidential and exempt
175 information in the database shall be released only as provided
176 in paragraph (c) and s. 893.0551.
177 (c) The following entities shall not be allowed direct
178 access to information in the prescription drug validation
179 program database but may request from the project manager and,
180 when authorized by the manager, the project manager’s support
181 staff, information that is confidential and exempt under s.
182 893.0551. The request shall be verified as authentic and
183 authorized with the requesting organization by the project
184 manager, the project manager’s support staff, or as determined
185 in rules by the department before providing the information to:
186 1. The department’s relevant health care regulatory boards
187 responsible for the licensure, regulation, or discipline of
188 practitioners, pharmacists, or other persons who are authorized
189 to prescribe, administer, or dispense controlled substances and
190 who are involved in a specific controlled substance
191 investigation involving a designated person for one or more
192 prescribed controlled substances.
193 2. The Attorney General for Medicaid fraud cases involving
194 prescribed controlled substances.
195 3. A law enforcement agency, as described in s.
196 893.0551(2)(c), during ongoing investigations as provided in s.
197 893.07 or during active investigations as defined in s. 119.011
198 regarding potential criminal activity, fraud, or theft regarding
199 prescribed controlled substances. The database information is
200 available only for criminal cases.
201
202 Information may be provided only to a patient or the legal
203 guardian of an incapacitated person as described in s. 893.0551
204 who submits a written and notarized request that includes the
205 patient’s full name, address, and date of birth in order to
206 check the accuracy of his or her own or the incapacitated
207 person’s records. The request shall be validated by the
208 department in order to verify that the identity is that of the
209 requestor and to include any request to change his or her
210 prescription history or other information related to his or her
211 information in the electronic database.
212 (d) The following entities shall not be allowed direct
213 access to information in the prescription drug validation
214 program database but may request from the project manager and,
215 when authorized by the manager, the project manager’s support
216 staff, information that does not contain any identifying
217 information of any patient, physician, health care practitioner,
218 prescriber, or dispenser and that is not confidential and
219 exempt:
220 1. Department staff for the purpose of calculating
221 performance measures pursuant to subsection (8).
222 2. The Program Implementation and Oversight Task Force for
223 its reporting to the Governor, the President of the Senate, and
224 the Speaker of the House of Representatives regarding the
225 prescription drug validation program. This subparagraph expires
226 July 1, 2012.
227 (e) All transmissions of data required by this section must
228 comply with relevant state and federal privacy and security laws
229 and regulations. However, any authorized agency or person
230 receiving such information as allowed by s. 893.0551 may
231 maintain the information received for up to 24 months before
232 purging it from his or her records or maintain it for longer
233 than 24 months if the information is pertinent to ongoing health
234 care or an active law enforcement investigation or prosecution.
235 (8) In order to assist in fulfilling program
236 responsibilities, performance measures shall be reported
237 annually to the Governor, the President of the Senate, and the
238 Speaker of the House of Representatives by the department each
239 December 1, beginning in 2011. Data that does not contain
240 patient, physician, health care practitioner, prescriber, or
241 dispenser identifying information may be requested during the
242 year by department employees so that the department may
243 undertake public health care and safety initiatives that take
244 advantage of observed trends. Performance measures may include,
245 but are not limited to, efforts to achieve the following
246 outcomes:
247 (a) Reduction of the rate of inappropriate use of
248 prescription drugs through department education and safety
249 efforts.
250 (b) Reduction of the quantity of pharmaceutical controlled
251 substances obtained by individuals attempting to engage in fraud
252 and deceit.
253 (c) Increased coordination among partners participating in
254 prescription drug validation program.
255 (d) Involvement of stakeholders in achieving improved
256 patient health care and safety and reduction of prescription
257 drug abuse and prescription drug diversion.
258 (9) Any person who knowingly fails to report the dispensing
259 of a controlled substance as required by this section commits a
260 misdemeanor of the first degree, punishable as provided in s.
261 775.082 or s. 775.083.
262 (10) All costs incurred by the department in administering
263 the prescription drug validation program shall be reimbursed
264 through federal grants or private funding applied for or
265 received by the state. The prescription drug validation program
266 and the implementation thereof are contingent upon receipt of
267 the nonstate funding, and specific legislative appropriation may
268 not be used to fund the program. The department and state
269 government shall cooperate with the direct-support organization
270 established pursuant to subsection (11) in seeking federal grant
271 funds, other nonstate grant funds, gifts, donations, or other
272 private moneys for the department so long as the costs of doing
273 so are not considered material. Nonmaterial costs for this
274 purpose include, but are not limited to, the costs of mailing
275 and personnel assigned to research or apply for a grant.
276 Notwithstanding the exemptions to competitive-solicitation
277 requirements under s. 287.057(5)(f), the department shall comply
278 with the competitive-solicitation requirements under s. 287.057
279 for the procurement of any goods or services required by this
280 section.
281 (11) The Office of Drug Control, in coordination with the
282 department, may establish a direct-support organization that has
283 a board consisting of at least five members to provide
284 assistance, funding, and promotional support for the activities
285 authorized for the prescription drug validation program.
286 (a) As used in this subsection, the term “direct-support
287 organization” means an organization that is:
288 1. A Florida corporation not for profit incorporated under
289 chapter 617, exempted from filing fees, and approved by the
290 Department of State.
291 2. Organized and operated to conduct programs and
292 activities; raise funds; request and receive grants, gifts, and
293 bequests of money; acquire, receive, hold, and invest, in its
294 own name, securities, funds, objects of value, or other
295 property, either real or personal; and make expenditures to or
296 for the direct or indirect benefit of the department in the
297 furtherance of the prescription drug validation program.
298 (b) The direct-support organization is not considered a
299 lobbying firm within the meaning of s. 11.045.
300 (c) The director of the Office of Drug Control shall
301 appoint a board of directors for the direct-support
302 organization. The director may designate employees of the Office
303 of Drug Control, state employees other than state employees from
304 the department, and any other nonstate employees as appropriate,
305 to serve on the board. Members of the board shall serve at the
306 pleasure of the director of the Office of Drug Control. The
307 director shall provide guidance to members of the board to
308 ensure that moneys received by the direct-support organization
309 are not received from inappropriate sources. Inappropriate
310 sources include, but are not limited to, donors, grantors,
311 persons, or organizations that may monetarily or substantively
312 benefit from the purchase of goods or services by the department
313 in furtherance of the prescription drug validation program.
314 (d) The direct-support organization shall operate under
315 written contract with the Office of Drug Control. The contract
316 must, at a minimum, provide for:
317 1. Approval of the articles of incorporation and bylaws of
318 the direct-support organization by the Office of Drug Control.
319 2. Submission of an annual budget for the approval of the
320 Office of Drug Control.
321 3. Certification by the Office of Drug Control in
322 consultation with the department that the direct-support
323 organization is complying with the terms of the contract in a
324 manner consistent with and in furtherance of the goals and
325 purposes of the prescription drug validation program and in the
326 best interests of the state. Such certification must be made
327 annually and reported in the official minutes of a meeting of
328 the direct-support organization.
329 4. The reversion, without penalty, to the Office of Drug
330 Control, or to the state if the Office of Drug Control ceases to
331 exist, of all moneys and property held in trust by the direct
332 support organization for the benefit of the prescription drug
333 validation program if the direct-support organization ceases to
334 exist or if the contract is terminated.
335 5. The fiscal year of the direct-support organization,
336 which must begin July 1 of each year and end June 30 of the
337 following year.
338 6. The disclosure of the material provisions of the
339 contract to donors of gifts, contributions, or bequests,
340 including such disclosure on all promotional and fundraising
341 publications, and an explanation to such donors of the
342 distinction between the Office of Drug Control and the direct
343 support organization.
344 7. The direct-support organization’s collecting, expending,
345 and providing of funds to the department for the development,
346 implementation, and operation of the prescription drug
347 validation program as described in subsections (2), (3), and
348 (4). The direct-support organization may collect and expend
349 funds to be used for the functions of the direct-support
350 organization’s board of directors, as necessary and approved by
351 the director of the Office of Drug Control. In addition, the
352 direct-support organization may collect and provide funding to
353 the department in furtherance of the prescription drug
354 validation program by:
355 a. Establishing and administering the prescription drug
356 validation program’s electronic database, including hardware,
357 software, and personnel.
358 b. Conducting studies on the efficiency and effectiveness
359 of the program.
360 c. Providing funds for future enhancements of the program
361 within the intent of this section.
362 d. Providing user training of the prescription drug
363 validation program, including distribution of materials to
364 promote public awareness and education and conducting workshops
365 or other meetings, for health care practitioners, pharmacists,
366 and others as appropriate.
367 e. Providing funds for travel expenses.
368 f. Providing funds for administrative costs, including
369 personnel, audits, facilities, and equipment.
370 g. Fulfilling all other requirements necessary to implement
371 and operate the program as outlined in this section.
372 (e) The activities of the direct-support organization must
373 be consistent with the goals and mission of the Office of Drug
374 Control, as determined by the office in consultation with the
375 department, and in the best interests of the state. The direct
376 support organization must obtain a written approval from the
377 director of the Office of Drug Control for any activities in
378 support of the prescription drug validation program before
379 undertaking those activities.
380 (f) The Office of Drug Control, in consultation with the
381 department, may permit, without charge, appropriate use of
382 administrative services, property, and facilities of the Office
383 of Drug Control and the department by the direct-support
384 organization, subject to this section. The use must be directly
385 in keeping with the approved purposes of the direct-support
386 organization and may not be made at times or places that would
387 unreasonably interfere with opportunities for the public to use
388 such facilities for established purposes. Any moneys received
389 from rentals of facilities and properties managed by the Office
390 of Drug Control and the department may be held by the Office of
391 Drug Control or in a separate depository account in the name of
392 the direct-support organization and subject to the provisions of
393 the letter of agreement with the Office of Drug Control. The
394 letter of agreement must provide that any funds held in the
395 separate depository account in the name of the direct-support
396 organization must revert to the Office of Drug Control if the
397 direct-support organization is no longer approved by the Office
398 of Drug Control to operate in the best interests of the state.
399 (g) The Office of Drug Control, in consultation with the
400 department, may adopt requirements with which a direct-support
401 organization must comply in order to use administrative
402 services, property, or facilities of the department or office.
403 (h) The Office of Drug Control may not permit the use of
404 any administrative services, property, or facilities of the
405 state by a direct-support organization if that organization does
406 not provide equal membership and employment opportunities to all
407 persons regardless of race, color, religion, gender, age, or
408 national origin.
409 (i) The direct-support organization shall provide for an
410 independent annual financial audit in accordance with s.
411 215.981. Copies of the audit shall be provided to the Office of
412 Drug Control and the Office of Policy and Budget in the
413 Executive Office of the Governor.
414 (j) The direct-support organization may not exercise any
415 power under s. 617.0302(12) or (16).
416 (12) A prescriber or dispenser may have access to the
417 information under this section which relates to a patient of
418 that prescriber or dispenser for the purpose of reviewing the
419 patient’s controlled drug prescription history to ensure a
420 proper standard of care. A prescriber or dispenser acting in
421 good faith is immune from any civil, criminal, or administrative
422 liability that might otherwise be incurred or imposed for
423 receiving or using information from the prescription drug
424 validation program. This subsection does not create a private
425 cause of action, and a person may not recover damages against a
426 prescriber or dispenser authorized to access information under
427 this subsection for accessing or failing to access such
428 information.
429 (13) To the extent that funding is provided for such
430 purpose through federal or private grants or gifts and other
431 types of available moneys, the department, in collaboration with
432 the Office of Drug Control, shall study the feasibility of
433 enhancing the prescription drug validation program for the
434 purposes of public health initiatives and statistical reporting
435 that respects the privacy of the patient, the prescriber, and
436 the dispenser. Such a study shall be conducted in order to
437 further improve the quality of health care services and safety
438 by improving prescription drug prescribing practices, taking
439 advantage of advances in technology, reducing duplicative
440 prescriptions and the overprescribing of prescription drugs, and
441 reducing drug abuse. In addition, the direct-support
442 organization shall provide funding for the department, in
443 collaboration with the Office of Drug Control, to conduct
444 training for health care practitioners and other appropriate
445 persons in using the validation program to support the program
446 enhancements.
447 (14) A pharmacist, pharmacy, or dispensing health care
448 practitioner or his or her agent, before releasing a controlled
449 substance to any person not known to such dispenser, shall
450 require the person purchasing, receiving, or otherwise acquiring
451 the controlled substance to present valid photographic
452 identification or other verification of his or her identity to
453 the dispenser. If the person does not have proper
454 identification, the dispenser may verify the validity of the
455 prescription and the identity of the patient with the prescriber
456 or his or her authorized agent, or by a method determined by the
457 department, before dispensing the controlled substance. The
458 person purchasing, receiving, or otherwise acquiring the
459 controlled substance need not be the specific patient to whom
460 the prescription is prescribed. A record may be maintained for 2
461 years of the person acquiring the controlled substance, which
462 record shall include the person’s name and signature using the
463 proper identification. This subsection does not apply in an
464 institutional setting or to a long-term care facility,
465 including, but not limited to, an assisted living facility or a
466 hospital to which patients are admitted. As used in this
467 subsection, the term “proper identification” means a government
468 issued identification containing the person’s photograph,
469 printed name, and signature.
470 (15) The Agency for Health Care Administration shall
471 continue the implementation of electronic prescribing by health
472 care practitioners, health care facilities, and pharmacies under
473 s. 408.061 and the electronic prescribing clearinghouse
474 collaboration with the private sector under s. 408.0611.
475 (16) By October 1, 2010, the department shall adopt rules
476 pursuant to ss. 120.536(1) and 120.54 to administer the
477 provisions of this section.
478 Section 2. (1) The Program Implementation and Oversight
479 Task Force is created within the Executive Office of the
480 Governor. The director of the Office of Drug Control shall be a
481 nonvoting, ex officio member of the task force and shall act as
482 chair. The Office of Drug Control and the Department of Health
483 shall provide staff support for the task force.
484 (a) The following state officials shall serve on the task
485 force:
486 1. The Attorney General or his or her designee.
487 2. The Secretary of Children and Family Services or his or
488 her designee.
489 3. The Secretary of Health Care Administration or his or
490 her designee.
491 4. The State Surgeon General or his or her designee.
492 (b) In addition, the Governor shall appoint 10 members of
493 the public to serve on the task force. Of these 10 appointed
494 members, one member must have professional or occupational
495 expertise in computer security; one member must be a Florida
496 licensed, board-certified oncologist; two members must be
497 Florida-licensed, board-certified, fellowship-trained physicians
498 who have experience in pain management; one member must have
499 professional or occupational expertise in e-Prescribing or
500 prescription drug validation programs; one member must be a
501 Florida-licensed pharmacist; one member must have professional
502 or occupational expertise in the area of law enforcement and
503 have experience in prescription drug investigations; one member
504 must have professional or occupational expertise as an
505 epidemiologist and have a background in tracking and analyzing
506 drug trends; and two members must have professional or
507 occupational expertise as providers of substance abuse
508 treatment, with priority given to a member who is a former
509 substance abuser.
510 (c) Members appointed by the Governor shall be appointed to
511 a term of 3 years each. Any vacancy on the task force shall be
512 filled in the same manner as the original appointment, and any
513 member appointed to fill a vacancy shall serve only for the
514 unexpired term of the member’s predecessor.
515 (d) Members of the task force and members of subcommittees
516 appointed under subsection (4) shall serve without compensation,
517 but are entitled to reimbursement for per diem and travel
518 expenses as provided in s. 112.061, Florida Statutes.
519 (e) The task force shall meet at least quarterly or upon
520 the call of the chair.
521 (2) The purpose of the task force is to monitor the
522 implementation and safeguarding of the electronic system
523 established for the prescription drug validation program under
524 s. 893.055, Florida Statutes, and to ensure privacy, protection
525 of individual medication history, and the electronic system’s
526 appropriate use by physicians, dispensers, pharmacies, law
527 enforcement agencies, and those authorized to request
528 information from the electronic system.
529 (3) The Office of Drug Control shall submit a report to the
530 Governor, the President of the Senate, and the Speaker of the
531 House of Representatives by December 1 of each year which
532 contains a summary of the work of the task force during that
533 year and the recommendations developed in accordance with the
534 task force’s purpose as provided in subsection (2). Interim
535 reports may be submitted at the discretion of the chair.
536 (4) The chair of the task force may appoint subcommittees
537 that include members of state agencies that are not represented
538 on the task force for the purpose of soliciting input and
539 recommendations from those state agencies as needed by the task
540 force to accomplish its purpose as provided in subsection (2).
541 In addition, the chair may appoint subcommittees as necessary
542 from among the members of the task force in order to efficiently
543 address specific issues. If a state agency is to be represented
544 on any subcommittee, the representative shall be the head of the
545 agency or his or her designee. The chair may designate lead and
546 contributing agencies within a subcommittee.
547 (5) The task force shall provide a final report in
548 accordance with the task force’s purpose as provided in
549 subsection (2) on July 1, 2012, to the Governor, the President
550 of the Senate, and the Speaker of the House of Representatives.
551 Such report shall be prepared using only data that does not
552 identify a patient or dispenser. The task force shall expire and
553 this section is repealed on that date unless reenacted by the
554 Legislature.
555 Section 3. Subsections (4) is added to section 458.309,
556 Florida Statutes, to read:
557 458.309 Rulemaking authority.—
558 (4)(a) Each physician who practices in a privately owned
559 pain-management facility and who primarily engages in the
560 treatment of pain by prescribing narcotic medications or
561 controlled substance medications shall register the facility
562 with the department unless it is licensed as a facility under
563 chapter 395. The department shall inspect the facility annually
564 to ensure that it complies with board rules adopted by the board
565 pursuant to paragraph (b) unless the facility is accredited by a
566 nationally recognized accrediting agency approved by the board.
567 The actual costs for registration and inspection or
568 accreditation shall be paid by the physician seeking to register
569 the facility. For the purposes of this subsection, a physician
570 is primarily engaged in the treatment of pain by prescribing
571 controlled substance medications when the majority of patients
572 seen on any day the facility is open are issued controlled
573 substance prescriptions for the treatment of nonmalignant pain.
574 (b) The board shall adopt rules setting forth standards of
575 practice for physicians who practice in privately owned pain
576 management facilities and who primarily engage in the treatment
577 of pain by prescribing controlled substance medications. These
578 rules shall address, but need not be limited to, the following
579 subjects:
580 1. Facility operations.
581 2. Physical operations.
582 3. Infection control requirements.
583 4. Health and safety requirements.
584 5. Quality assurance requirements.
585 6. Patient records.
586 7. Training requirements for all facility health care
587 practitioners.
588 8. Inspections.
589 Section 4. Subsections (3) is added to section 459.005,
590 Florida Statutes, to read:
591 459.005 Rulemaking authority.—
592 (3)(a) Each osteopathic physician who practices in a
593 privately owned pain-management facility and who primarily
594 engages in the treatment of pain by prescribing narcotic
595 medications or controlled substance medications shall register
596 the facility with the department unless the facility is licensed
597 as a facility under chapter 395. The department shall inspect
598 the facility annually to ensure that it complies with board
599 rules adopted by the board pursuant to paragraph (b) unless the
600 facility is accredited by a nationally recognized accrediting
601 agency approved by the board. The actual costs for registration
602 and inspection or accreditation shall be paid by the physician
603 seeking to register the facility. For the purposes of this
604 subsection, an osteopathic physician is primarily engaged in the
605 treatment of pain by prescribing controlled substance
606 medications when the majority of patients seen on any day the
607 facility is open are issued controlled substance prescriptions
608 for the treatment of nonmalignant pain.
609 (b) The board shall adopt rules setting forth standards of
610 practice for osteopathic physicians who practice in privately
611 owned pain-management facilities and who primarily engage in the
612 treatment of pain by prescribing controlled substance
613 medications. These rules shall address, but need not be limited
614 to, the following subjects:
615 1. Facility operations.
616 2. Physical operations.
617 3. Infection control requirements.
618 4. Health and safety requirements.
619 5. Quality assurance requirements.
620 6. Patient records.
621 7. Training requirements for all facility health care
622 practitioners.
623 8. Inspections.
624 Section 5. This act shall take effect July 1, 2009.
625
626 ================= T I T L E A M E N D M E N T ================
627 And the title is amended as follows:
628 Delete everything before the enacting clause
629 and insert:
630 A bill to be entitled
631 An act relating to prescription drugs; creating s.
632 893.055, F.S.; providing definitions; requiring the
633 Department of Health to establish a comprehensive
634 electronic system to validate the prescribing and
635 dispensing of certain controlled substances; requiring
636 specified prescribing and dispensing information to be
637 reported to the electronic system; requiring the
638 department, in conjunction with specified
639 organizations, to adopt by rule a reasonable-person
640 standard appropriate for the prescription drug
641 validation program; providing reporting requirements;
642 providing a reporting period; providing exemptions
643 from participation in the system; authorizing the
644 department to establish when to suspend and when to
645 resume reporting requirements during declared
646 emergencies; requiring all nonexempt, dispensing
647 pharmacists and practitioners to submit information in
648 a specified format; providing that the cost to the
649 dispenser in submitting the required information may
650 not be material or extraordinary; specifying costs
651 that are not material or extraordinary; providing
652 access to information reported to the system under
653 certain circumstances; providing for the use of data
654 for specified purposes; requiring data transmission to
655 comply with state and federal privacy and security
656 laws; authorizing an agency or person to maintain the
657 data for a specified period if the data is pertinent
658 to ongoing health care or an active law enforcement
659 investigation or prosecution; requiring the annual
660 reporting of certain performance measures to the
661 Governor and Legislature; providing performance
662 measure criteria; providing criminal penalties for
663 violations; requiring that all costs incurred by the
664 department for the program be reimbursed through
665 federal grants or available private funding sources;
666 providing requirements for seeking funding and
667 procuring goods or services; authorizing the Office of
668 Drug Control, in coordination with the department, to
669 establish a direct-support organization; providing a
670 definition; providing for a board of directors
671 appointed by the director of the office; requiring the
672 director to provide guidance to the board regarding
673 acceptance of moneys from appropriate sources;
674 requiring the direct-support organization to operate
675 under written contract with the office; providing
676 contract requirements; requiring department approval
677 of activities of the direct-support organization;
678 providing requirements for the use of certain
679 facilities and services; providing for audits;
680 prohibiting the direct-support organization from
681 exercising certain powers; establishing that a
682 prescriber or dispenser is not liable for good faith
683 use of the department-provided controlled substance
684 prescription information of a patient; requiring a
685 study of the feasibility of enhancing the prescription
686 drug validation program for specified purposes to the
687 extent that funding is provided for such purpose;
688 requiring certain persons to present specified
689 identification in order to obtain controlled
690 substances; providing for recordkeeping for certain
691 transactions; requiring the Agency for Health Care
692 Administration to continue implementation of
693 electronic prescribing and an electronic prescribing
694 clearinghouse; requiring the department to adopt
695 rules; establishing a Program Implementation and
696 Oversight Task Force; providing for membership;
697 providing for reimbursement of certain member
698 expenses; providing for meetings; providing the
699 purpose of the task force; requiring reports to the
700 Governor and Legislature; providing for the creation,
701 membership, and duties of subcommittees; providing for
702 a final report and the termination of the task force;
703 amending ss. 458.309 and 459.005, F.S.; requiring
704 certain physicians who engage in pain management to
705 register their facilities with the department;
706 requiring the department to inspect each facility;
707 providing for exceptions; requiring the Board of
708 Medicine and the Board of Osteopathic Medicine to
709 adopt rules setting forth standards of practice for
710 certain physicians who engage in pain management;
711 providing criteria for the rules; providing an
712 effective date.
713
714 WHEREAS, as has been advocated by numerous pain management
715 experts, addiction medicine experts, pharmacists, and law
716 enforcement personnel, a prescription drug validation program
717 that provides for reporting and advisory information is
718 established pursuant to this act to serve as a means to promote
719 the public health and welfare and to detect and prevent
720 controlled substance abuse and diversion, and
721 WHEREAS, while the importance and necessity of the proper
722 prescribing, dispensing, and monitoring of controlled
723 substances, particularly pain medication, have been established,
724 controlled prescription drugs are too often diverted in this
725 state, often through fraudulent means, including outright theft,
726 phony pharmacy fronts, loose Internet medical evaluations, and
727 inappropriate importation; in addition, there is a criminal
728 element that facilitates the prescription drug abuse epidemic
729 through illegal profitmaking from the diversion of certain
730 controlled substances that are prescribed or dispensed by
731 physicians, health care practitioners, and pharmacists, and
732 WHEREAS, in 2007, 8,620 drug-related deaths occurred in
733 this state, 3,159 of which were caused by prescription drugs, an
734 average of nearly 9 Floridians dying each day from prescription
735 drugs; Schedule IV benzodiazepines, such as Xanax and Valium,
736 were found to be present in more drug-related deaths than
737 cocaine; and opiate pain medications were found to be
738 contributing to increasing numbers of drug-related deaths, and
739 WHEREAS, pharmaceutical drug diversion hurts this state
740 significantly in terms of lost lives, increased crime, human
741 misery from addiction, and ballooning health care costs
742 connected to treatment, medical expenses, and Medicaid fraud
743 that all Floridians ultimately bear, and
744 WHEREAS, the intent of this act is not to interfere with
745 the legitimate medical use of controlled substances; however,
746 the people of this state are in need of and will benefit from a
747 secure and privacy-protected statewide electronic system of
748 specified prescription drug medication information created
749 primarily to encourage safer controlled substance prescription
750 decisions that reduce the number of prescription drug overdoses
751 and the number of drug overdose deaths; to educate and inform
752 health care practitioners and provide an added tool in patient
753 care, including appropriate treatment for patients who have
754 become addicted; to guide public health initiatives to educate
755 the population on the dangers of misusing prescription drugs; to
756 prevent the abuse or diversion of prescribed controlled
757 substances; and to ensure that those who need prescribed
758 controlled substances receive them in a manner that protects
759 patient confidentiality, and
760 WHEREAS, while certain medicines are very helpful if
761 properly prescribed to a patient in need and then used as
762 prescribed, they may be dangerous or even deadly if improperly
763 dispensed, misused, or diverted, and
764 WHEREAS, it is the intent of the Legislature to encourage
765 patient safety, responsible pain management, and proper access
766 to useful prescription drugs that are prescribed by a
767 knowledgeable, properly licensed health care practitioner who
768 dispenses prescription drugs and that are dispensed by a
769 pharmacist who is made aware of the patient’s prescription drug
770 medication history, thus preventing, in some cases, an abuse or
771 addiction problem from developing or worsening, making such a
772 problem possible or easier to identify, and facilitating the
773 order of appropriate medical treatment or referral, and
774 WHEREAS, such an electronic system will also aid
775 administrative and law enforcement agencies in an active and
776 ongoing controlled substance-related investigation, maintaining
777 such information for any such investigation with a reasonable,
778 good faith anticipation of securing an arrest or prosecution in
779 the foreseeable future, and
780 WHEREAS, a Program Implementation and Oversight Task Force
781 will provide information to the Governor and Legislature
782 regarding the implementation of the program and ensure that
783 privacy and confidentiality of the patient’s prescription
784 history is respected, NOW, THEREFORE,