Florida Senate - 2009 CS for CS for SB 462
By the Committees on Judiciary; and Health Regulation; and
Senator Fasano
590-03445-09 2009462c2
1 A bill to be entitled
2 An act relating to prescription drugs; creating s.
3 893.055, F.S.; providing definitions; requiring the
4 Department of Health to establish a comprehensive
5 electronic system to validate the prescribing and
6 dispensing of certain controlled substances; requiring
7 specified prescribing and dispensing information to be
8 reported to the electronic system; requiring the
9 department, in conjunction with specified
10 organizations, to adopt by rule a reasonable-person
11 standard appropriate for the prescription drug
12 validation program; providing reporting requirements;
13 providing a reporting period; providing exemptions
14 from participation in the system; authorizing the
15 department to establish when to suspend and when to
16 resume reporting requirements during declared
17 emergencies; requiring all nonexempt, dispensing
18 pharmacists and practitioners to submit information in
19 a specified format; providing that the cost to the
20 dispenser in submitting the required information may
21 not be material or extraordinary; specifying costs
22 that are not material or extraordinary; providing
23 access to information reported to the system under
24 certain circumstances; providing for the use of data
25 for specified purposes; requiring data transmission to
26 comply with state and federal privacy and security
27 laws; authorizing an agency or person to maintain the
28 data for a specified period if the data is pertinent
29 to ongoing health care or an active law enforcement
30 investigation or prosecution; requiring the annual
31 reporting of certain performance measures to the
32 Governor and Legislature; providing performance
33 measure criteria; providing criminal penalties for
34 violations; requiring that all costs incurred by the
35 department for the program be reimbursed through
36 federal grants or available private funding sources;
37 providing requirements for seeking funding and
38 procuring goods or services; authorizing the Office of
39 Drug Control, in coordination with the department, to
40 establish a direct-support organization; providing a
41 definition; providing for a board of directors
42 appointed by the director of the office; requiring the
43 director to provide guidance to the board regarding
44 acceptance of moneys from appropriate sources;
45 requiring the direct-support organization to operate
46 under written contract with the office; providing
47 contract requirements; requiring department approval
48 of activities of the direct-support organization;
49 providing requirements for the use of certain
50 facilities and services; providing for audits;
51 prohibiting the direct-support organization from
52 exercising certain powers; establishing that a
53 prescriber or dispenser is not liable for good faith
54 use of the department-provided controlled substance
55 prescription information of a patient; requiring a
56 study of the feasibility of enhancing the prescription
57 drug validation program for specified purposes to the
58 extent that funding is provided for such purpose;
59 requiring certain persons to present specified
60 identification in order to obtain controlled
61 substances; providing for recordkeeping for certain
62 transactions; requiring the Agency for Health Care
63 Administration to continue implementation of
64 electronic prescribing and an electronic prescribing
65 clearinghouse; requiring the department to adopt
66 rules; establishing a Program Implementation and
67 Oversight Task Force; providing for membership;
68 providing for reimbursement of certain member
69 expenses; providing for meetings; providing the
70 purpose of the task force; requiring reports to the
71 Governor and Legislature; providing for the creation,
72 membership, and duties of subcommittees; providing for
73 a final report and the termination of the task force;
74 amending ss. 458.309 and 459.005, F.S.; requiring
75 certain physicians who engage in pain management to
76 register their facilities with the department;
77 requiring the department to inspect each facility;
78 providing for exceptions; requiring the Board of
79 Medicine and the Board of Osteopathic Medicine to
80 adopt rules setting forth standards of practice for
81 certain physicians who engage in pain management;
82 providing criteria for the rules; providing an
83 effective date.
84
85 WHEREAS, as has been advocated by numerous pain management
86 experts, addiction medicine experts, pharmacists, and law
87 enforcement personnel, a prescription drug validation program
88 that provides for reporting and advisory information is
89 established pursuant to this act to serve as a means to promote
90 the public health and welfare and to detect and prevent
91 controlled substance abuse and diversion, and
92 WHEREAS, while the importance and necessity of the proper
93 prescribing, dispensing, and monitoring of controlled
94 substances, particularly pain medication, have been established,
95 controlled prescription drugs are too often diverted in this
96 state, often through fraudulent means, including outright theft,
97 phony pharmacy fronts, loose Internet medical evaluations, and
98 inappropriate importation; in addition, there is a criminal
99 element that facilitates the prescription drug abuse epidemic
100 through illegal profitmaking from the diversion of certain
101 controlled substances that are prescribed or dispensed by
102 physicians, health care practitioners, and pharmacists, and
103 WHEREAS, in 2007, 8,620 drug-related deaths occurred in
104 this state, 3,159 of which were caused by prescription drugs, an
105 average of nearly nine Floridians dying each day from
106 prescription drugs; Schedule IV benzodiazepines, such as Xanax
107 and Valium, were found to be present in more drug-related deaths
108 than cocaine; and opiate pain medications were found to be
109 contributing to increasing numbers of drug-related deaths, and
110 WHEREAS, pharmaceutical drug diversion hurts this state
111 significantly in terms of lost lives, increased crime, human
112 misery from addiction, and ballooning health care costs
113 connected to treatment, medical expenses, and Medicaid fraud
114 that all Floridians ultimately bear, and
115 WHEREAS, the intent of this act is not to interfere with
116 the legitimate medical use of controlled substances; however,
117 the people of this state are in need of and will benefit from a
118 secure and privacy-protected statewide electronic system of
119 specified prescription drug medication information created
120 primarily to encourage safer controlled substance prescription
121 decisions that reduce the number of prescription drug overdoses
122 and the number of drug overdose deaths; to educate and inform
123 health care practitioners and provide an added tool in patient
124 care, including appropriate treatment for patients who have
125 become addicted; to guide public health initiatives to educate
126 the population on the dangers of misusing prescription drugs; to
127 prevent the abuse or diversion of prescribed controlled
128 substances; and to ensure that those who need prescribed
129 controlled substances receive them in a manner that protects
130 patient confidentiality, and
131 WHEREAS, while certain medicines are very helpful if
132 properly prescribed to a patient in need and then used as
133 prescribed, they may be dangerous or even deadly if improperly
134 dispensed, misused, or diverted, and
135 WHEREAS, it is the intent of the Legislature to encourage
136 patient safety, responsible pain management, and proper access
137 to useful prescription drugs that are prescribed by a
138 knowledgeable, properly licensed health care practitioner who
139 dispenses prescription drugs and that are dispensed by a
140 pharmacist who is made aware of the patient’s prescription drug
141 medication history, thus preventing, in some cases, an abuse or
142 addiction problem from developing or worsening, making such a
143 problem possible or easier to identify, and facilitating the
144 order of appropriate medical treatment or referral, and
145 WHEREAS, such an electronic system will also aid
146 administrative and law enforcement agencies in an active and
147 ongoing controlled substance-related investigation, maintaining
148 such information for any such investigation with a reasonable,
149 good faith anticipation of securing an arrest or prosecution in
150 the foreseeable future, and
151 WHEREAS, a Program Implementation and Oversight Task Force
152 will provide information to the Governor and Legislature
153 regarding the implementation of the program and ensure that
154 privacy and confidentiality of the patient’s prescription
155 history is respected, NOW, THEREFORE,
156
157 Be It Enacted by the Legislature of the State of Florida:
158
159 Section 1. Section 893.055, Florida Statutes, is created to
160 read:
161 893.055 Prescription drug validation program.—
162 (1) As used in this section, the term:
163 (a) “Advisory report” means information provided by the
164 department in writing to a prescriber, dispenser, pharmacy, or
165 patient concerning the dispensing of controlled substances. All
166 advisory reports are for informational purposes only and impose
167 no obligations of any nature or any legal duty on a prescriber,
168 dispenser, pharmacy, or patient. The advisory reports issued by
169 the department are not subject to discovery or introduction into
170 evidence in any civil or administrative action against a
171 prescriber, dispenser, pharmacy, or patient arising out of
172 matters that are the subject of the report, and a person who
173 participates in preparing an advisory report may not be
174 permitted or required to testify in any such civil action as to
175 any findings, recommendations, evaluations, opinions, or other
176 actions taken in connection with preparing such a report.
177 (b) “Controlled substance” means a controlled substance
178 listed in Schedule II, Schedule III, or Schedule IV in s.
179 893.03.
180 (c) “Dispenser” means a dispensing pharmacist or dispensing
181 health care practitioner.
182 (d) “Health care practitioner” or “practitioner” means any
183 practitioner who is subject to licensure or regulation by the
184 department under chapter 458, chapter 459, chapter 461, chapter
185 462, chapter 464, chapter 465, or chapter 466.
186 (e) “Health care regulatory board” means any board for a
187 practitioner or health care practitioner who is licensed or
188 regulated by the department.
189 (f) “Pharmacy” means any pharmacy that is subject to
190 licensure or regulation by the department under chapter 465 and
191 that dispenses or delivers a controlled substance to a patient
192 in this state.
193 (g) “Prescriber” means a prescribing physician, prescribing
194 practitioner, or other prescribing health care practitioner.
195 (2)(a) By December 1, 2010, the department shall design and
196 establish a comprehensive electronic system that has controlled
197 substance prescriptions provided to it and that provides
198 prescription information to a patient’s health care practitioner
199 and pharmacist who inform the department that they wish the
200 patient advisory report provided to them. Otherwise, the patient
201 advisory report will not be sent to the practitioner, pharmacy,
202 or pharmacist. The system shall be designed to provide
203 information regarding dispensed prescriptions of controlled
204 substances in order to prevent the inadvertent, improper, or
205 illegal use of controlled substances and may not infringe upon
206 the legitimate prescribing or dispensing of a controlled
207 substance by a prescriber or dispenser acting in good faith and
208 in the course of professional practice. The system shall be
209 consistent with standards of the American Society for Automation
210 in Pharmacy (ASAP) for the validation of the prescribing and
211 dispensing of controlled substances to an individual. The
212 electronic system shall also comply with the Health Insurance
213 Portability and Accountability Act (HIPAA) as it pertains to
214 protected health information (PHI), electronic protected health
215 information (EPHI), and all other relevant state and federal
216 privacy and security laws and regulations. The validating of
217 prescribed controlled substances shall include a dispensing
218 transaction with a dispenser who is not located in this state
219 but who is otherwise subject to the jurisdiction of this state
220 as to that dispensing transaction. The reporting of patient
221 advisories only refers to reports to pharmacists and
222 practitioners. Separate reports that are not patient advisory
223 reports are provided to persons and entities as authorized in
224 this section and s. 893.0551.
225 (b) The department shall adopt rules as necessary
226 concerning the reporting, accessing, evaluation, management,
227 development, implementation, operation, and storage of
228 information within the system, including rules for when patient
229 advisory reports and patient information is provided to
230 pharmacies, prescribers, and health care practitioners and rules
231 for when health care regulatory boards and law enforcement
232 agencies are provided patient prescription history information
233 from the database unless provision of such information is
234 otherwise described in this section. Such rules shall be
235 developed with a reasonable-person standard for controlled
236 prescription drug dispensers, prescribers, and patients. The
237 department shall work with the professional health care
238 licensure boards, such as the Board of Medicine and the Board of
239 Pharmacy; other appropriate organizations, such as the Florida
240 Pharmacy Association and the Florida Medical Association,
241 including those relating to pain management; and the Attorney
242 General, the Department of Law Enforcement, and the Agency for
243 Health Care Administration, to develop the reasonable-person
244 standard for rules appropriate for the prescription drug
245 validation program.
246 (c) All dispensers and prescribers subject to these
247 reporting requirements shall be notified by the department of
248 the implementation date for such reporting requirements.
249 (3) The pharmacy dispensing the controlled substance and
250 each prescriber who directly dispenses a controlled substance
251 shall submit to the electronic system, by a procedure and in a
252 format established by the department and consistent with an ASAP
253 format, the following information for inclusion in the database:
254 (a) The name of the prescribing practitioner, the
255 practitioner’s federal Drug Enforcement Administration
256 registration number, the practitioner’s National Provider
257 Identification (NPI) or other appropriate identifier, and the
258 date of the prescription.
259 (b) The date the prescription was filled and the method of
260 payment, including cash. This paragraph does not authorize the
261 department to include individual credit card or other account
262 numbers in the database.
263 (c) The full name, address, and date of birth of the person
264 for whom the prescription was written.
265 (d) The name, national drug code, quantity, and strength of
266 the controlled substance dispensed.
267 (e) The full name and address of the pharmacy or other
268 location from which the controlled substance was dispensed.
269 (f) The full name of the pharmacist or practitioner
270 dispensing the controlled substance and the practitioner’s
271 National Provider Identification (NPI).
272 (g) Other appropriate identifying information as determined
273 by department rule.
274 (4) Each time a controlled substance is dispensed to an
275 individual, the controlled substance shall be reported to the
276 department through the system as soon thereafter as possible,
277 but not more than 15 days after the date the controlled
278 substance is dispensed. A dispenser must meet the reporting
279 requirements of this section by providing the required
280 information concerning each controlled substance that it
281 dispensed in a department-approved, secure methodology and
282 format. Such approved formats may include, but are not limited
283 to, submission via the Internet, on a disc, or by use of regular
284 mail.
285 (5) The following are exempt from this section when
286 administering a controlled substance:
287 (a) A health care practitioner administering a controlled
288 substance directly to a patient if the amount of the controlled
289 substance is adequate to treat the patient during that
290 particular treatment session.
291 (b) A pharmacist or health care practitioner administering
292 a controlled substance to a patient or resident receiving care
293 as a patient at a hospital, nursing home, ambulatory surgical
294 center, hospice, or intermediate care facility for the
295 developmentally disabled which is licensed in this state.
296 (c) A practitioner administering a controlled substance in
297 the health care system of the Department of Corrections.
298 (d) A practitioner administering a controlled substance in
299 the emergency room of a licensed hospital.
300 (e) A health care practitioner administering a controlled
301 substance to a person under the age of 16.
302 (6) The department may establish when to suspend and when
303 to resume reporting information during a state-declared or
304 nationally declared disaster.
305 (7)(a) A practitioner or pharmacist who dispenses a
306 controlled substance must submit the information required by
307 this section in an electronic or other ASAP format approved by
308 rule of the department unless otherwise provided in this
309 section. The cost to the dispenser in submitting the information
310 required by this section may not be material or extraordinary.
311 Costs not considered to be material or extraordinary include,
312 but are not limited to, regular postage, electronic media,
313 regular electronic mail, and facsimile charges.
314 (b) A pharmacy, prescriber, or dispenser may have direct
315 access to information in the prescription drug validation
316 program’s electronic system database which relates to a patient
317 of that pharmacy, prescriber, or dispenser in a manner
318 established by the department for the purpose of reviewing the
319 patient’s controlled substance prescription history to ensure a
320 proper standard of care. Other access to the program’s
321 electronic system database shall be limited to the program’s
322 manager and to designated program staff, who may act only at the
323 direction of the program manager or in the absence of the
324 program manager. Access by the program manager or such
325 designated staff is for prescription drug management only or for
326 management of the program’s database in support of the
327 requirements of this section and in furtherance of the
328 prescription drug validation program. Confidential and exempt
329 information in the database shall be released only as provided
330 in paragraph (c) and s. 893.0551.
331 (c) The following entities shall not be allowed direct
332 access to information in the prescription drug validation
333 program database but may request from the project manager and,
334 when authorized by the manager, the project manager’s support
335 staff, information that is confidential and exempt under s.
336 893.0551. The request shall be verified as authentic and
337 authorized with the requesting organization by the project
338 manager, the project manager’s support staff, or as determined
339 in rules by the department before providing the information to:
340 1. The department’s relevant health care regulatory boards
341 responsible for the licensure, regulation, or discipline of
342 practitioners, pharmacists, or other persons who are authorized
343 to prescribe, administer, or dispense controlled substances and
344 who are involved in a specific controlled substance
345 investigation involving a designated person for one or more
346 prescribed controlled substances.
347 2. The Attorney General for Medicaid fraud cases involving
348 prescribed controlled substances.
349 3. A law enforcement agency, as described in s.
350 893.0551(2)(c), during ongoing investigations as provided in s.
351 893.07 or during active investigations as defined in s. 119.011
352 regarding potential criminal activity, fraud, or theft regarding
353 prescribed controlled substances. The database information is
354 available only for criminal cases.
355
356 Information may be provided only to a patient or the legal
357 guardian of an incapacitated person as described in s. 893.0551
358 who submits a written and notarized request that includes the
359 patient’s full name, address, and date of birth in order to
360 check the accuracy of his or her own or the incapacitated
361 person’s records. The request shall be validated by the
362 department in order to verify that the identity is that of the
363 requestor and to include any request to change his or her
364 prescription history or other information related to his or her
365 information in the electronic database.
366 (d) The following entities shall not be allowed direct
367 access to information in the prescription drug validation
368 program database but may request from the project manager and,
369 when authorized by the manager, the project manager’s support
370 staff, information that does not contain any identifying
371 information of any patient, physician, health care practitioner,
372 prescriber, or dispenser and that is not confidential and
373 exempt:
374 1. Department staff for the purpose of calculating
375 performance measures pursuant to subsection (8).
376 2. The Program Implementation and Oversight Task Force for
377 its reporting to the Governor, the President of the Senate, and
378 the Speaker of the House of Representatives regarding the
379 prescription drug validation program. This subparagraph expires
380 July 1, 2012.
381 (e) All transmissions of data required by this section must
382 comply with relevant state and federal privacy and security laws
383 and regulations. However, any authorized agency or person
384 receiving such information as allowed by s. 893.0551 may
385 maintain the information received for up to 24 months before
386 purging it from his or her records or maintain it for longer
387 than 24 months if the information is pertinent to ongoing health
388 care or an active law enforcement investigation or prosecution.
389 (8) In order to assist in fulfilling program
390 responsibilities, performance measures shall be reported
391 annually to the Governor, the President of the Senate, and the
392 Speaker of the House of Representatives by the department each
393 December 1, beginning in 2011. Data that does not contain
394 patient, physician, health care practitioner, prescriber, or
395 dispenser identifying information may be requested during the
396 year by department employees so that the department may
397 undertake public health care and safety initiatives that take
398 advantage of observed trends. Performance measures may include,
399 but are not limited to, efforts to achieve the following
400 outcomes:
401 (a) Reduction of the rate of inappropriate use of
402 prescription drugs through department education and safety
403 efforts.
404 (b) Reduction of the quantity of pharmaceutical controlled
405 substances obtained by individuals attempting to engage in fraud
406 and deceit.
407 (c) Increased coordination among partners participating in
408 prescription drug validation program.
409 (d) Involvement of stakeholders in achieving improved
410 patient health care and safety and reduction of prescription
411 drug abuse and prescription drug diversion.
412 (9) Any person who knowingly fails to report the dispensing
413 of a controlled substance as required by this section commits a
414 misdemeanor of the first degree, punishable as provided in s.
415 775.082 or s. 775.083.
416 (10) All costs incurred by the department in administering
417 the prescription drug validation program shall be reimbursed
418 through federal grants or private funding applied for or
419 received by the state. The prescription drug validation program
420 and the implementation thereof are contingent upon receipt of
421 the nonstate funding, and specific legislative appropriation may
422 not be used to fund the program. The department and state
423 government shall cooperate with the direct-support organization
424 established pursuant to subsection (11) in seeking federal grant
425 funds, other nonstate grant funds, gifts, donations, or other
426 private moneys for the department so long as the costs of doing
427 so are not considered material. Nonmaterial costs for this
428 purpose include, but are not limited to, the costs of mailing
429 and personnel assigned to research or apply for a grant.
430 Notwithstanding the exemptions to competitive-solicitation
431 requirements under s. 287.057(5)(f), the department shall comply
432 with the competitive-solicitation requirements under s. 287.057
433 for the procurement of any goods or services required by this
434 section.
435 (11) The Office of Drug Control, in coordination with the
436 department, may establish a direct-support organization that has
437 a board consisting of at least five members to provide
438 assistance, funding, and promotional support for the activities
439 authorized for the prescription drug validation program.
440 (a) As used in this subsection, the term “direct-support
441 organization” means an organization that is:
442 1. A Florida corporation not for profit incorporated under
443 chapter 617, exempted from filing fees, and approved by the
444 Department of State.
445 2. Organized and operated to conduct programs and
446 activities; raise funds; request and receive grants, gifts, and
447 bequests of money; acquire, receive, hold, and invest, in its
448 own name, securities, funds, objects of value, or other
449 property, either real or personal; and make expenditures to or
450 for the direct or indirect benefit of the department in the
451 furtherance of the prescription drug validation program.
452 (b) The direct-support organization is not considered a
453 lobbying firm within the meaning of s. 11.045.
454 (c) The director of the Office of Drug Control shall
455 appoint a board of directors for the direct-support
456 organization. The director may designate employees of the Office
457 of Drug Control, state employees other than state employees from
458 the department, and any other nonstate employees as appropriate,
459 to serve on the board. Members of the board shall serve at the
460 pleasure of the director of the Office of Drug Control. The
461 director shall provide guidance to members of the board to
462 ensure that moneys received by the direct-support organization
463 are not received from inappropriate sources. Inappropriate
464 sources include, but are not limited to, donors, grantors,
465 persons, or organizations that may monetarily or substantively
466 benefit from the purchase of goods or services by the department
467 in furtherance of the prescription drug validation program.
468 (d) The direct-support organization shall operate under
469 written contract with the Office of Drug Control. The contract
470 must, at a minimum, provide for:
471 1. Approval of the articles of incorporation and bylaws of
472 the direct-support organization by the Office of Drug Control.
473 2. Submission of an annual budget for the approval of the
474 Office of Drug Control.
475 3. Certification by the Office of Drug Control in
476 consultation with the department that the direct-support
477 organization is complying with the terms of the contract in a
478 manner consistent with and in furtherance of the goals and
479 purposes of the prescription drug validation program and in the
480 best interests of the state. Such certification must be made
481 annually and reported in the official minutes of a meeting of
482 the direct-support organization.
483 4. The reversion, without penalty, to the Office of Drug
484 Control, or to the state if the Office of Drug Control ceases to
485 exist, of all moneys and property held in trust by the direct
486 support organization for the benefit of the prescription drug
487 validation program if the direct-support organization ceases to
488 exist or if the contract is terminated.
489 5. The fiscal year of the direct-support organization,
490 which must begin July 1 of each year and end June 30 of the
491 following year.
492 6. The disclosure of the material provisions of the
493 contract to donors of gifts, contributions, or bequests,
494 including such disclosure on all promotional and fundraising
495 publications, and an explanation to such donors of the
496 distinction between the Office of Drug Control and the direct
497 support organization.
498 7. The direct-support organization’s collecting, expending,
499 and providing of funds to the department for the development,
500 implementation, and operation of the prescription drug
501 validation program as described in subsections (2), (3), and
502 (4). The direct-support organization may collect and expend
503 funds to be used for the functions of the direct-support
504 organization’s board of directors, as necessary and approved by
505 the director of the Office of Drug Control. In addition, the
506 direct-support organization may collect and provide funding to
507 the department in furtherance of the prescription drug
508 validation program by:
509 a. Establishing and administering the prescription drug
510 validation program’s electronic database, including hardware,
511 software, and personnel.
512 b. Conducting studies on the efficiency and effectiveness
513 of the program.
514 c. Providing funds for future enhancements of the program
515 within the intent of this section.
516 d. Providing user training of the prescription drug
517 validation program, including distribution of materials to
518 promote public awareness and education and conducting workshops
519 or other meetings, for health care practitioners, pharmacists,
520 and others as appropriate.
521 e. Providing funds for travel expenses.
522 f. Providing funds for administrative costs, including
523 personnel, audits, facilities, and equipment.
524 g. Fulfilling all other requirements necessary to implement
525 and operate the program as outlined in this section.
526 (e) The activities of the direct-support organization must
527 be consistent with the goals and mission of the Office of Drug
528 Control, as determined by the office in consultation with the
529 department, and in the best interests of the state. The direct
530 support organization must obtain a written approval from the
531 director of the Office of Drug Control for any activities in
532 support of the prescription drug validation program before
533 undertaking those activities.
534 (f) The Office of Drug Control, in consultation with the
535 department, may permit, without charge, appropriate use of
536 administrative services, property, and facilities of the Office
537 of Drug Control and the department by the direct-support
538 organization, subject to this section. The use must be directly
539 in keeping with the approved purposes of the direct-support
540 organization and may not be made at times or places that would
541 unreasonably interfere with opportunities for the public to use
542 such facilities for established purposes. Any moneys received
543 from rentals of facilities and properties managed by the Office
544 of Drug Control and the department may be held by the Office of
545 Drug Control or in a separate depository account in the name of
546 the direct-support organization and subject to the provisions of
547 the letter of agreement with the Office of Drug Control. The
548 letter of agreement must provide that any funds held in the
549 separate depository account in the name of the direct-support
550 organization must revert to the Office of Drug Control if the
551 direct-support organization is no longer approved by the Office
552 of Drug Control to operate in the best interests of the state.
553 (g) The Office of Drug Control, in consultation with the
554 department, may adopt requirements with which a direct-support
555 organization must comply in order to use administrative
556 services, property, or facilities of the department or office.
557 (h) The Office of Drug Control may not permit the use of
558 any administrative services, property, or facilities of the
559 state by a direct-support organization if that organization does
560 not provide equal membership and employment opportunities to all
561 persons regardless of race, color, religion, gender, age, or
562 national origin.
563 (i) The direct-support organization shall provide for an
564 independent annual financial audit in accordance with s.
565 215.981. Copies of the audit shall be provided to the Office of
566 Drug Control and the Office of Policy and Budget in the
567 Executive Office of the Governor.
568 (j) The direct-support organization may not exercise any
569 power under s. 617.0302(12) or (16).
570 (12) A prescriber or dispenser may have access to the
571 information under this section which relates to a patient of
572 that prescriber or dispenser for the purpose of reviewing the
573 patient’s controlled drug prescription history to ensure a
574 proper standard of care. A prescriber or dispenser acting in
575 good faith is immune from any civil, criminal, or administrative
576 liability that might otherwise be incurred or imposed for
577 receiving or using information from the prescription drug
578 validation program. This subsection does not create a private
579 cause of action, and a person may not recover damages against a
580 prescriber or dispenser authorized to access information under
581 this subsection for accessing or failing to access such
582 information.
583 (13) To the extent that funding is provided for such
584 purpose through federal or private grants or gifts and other
585 types of available moneys, the department, in collaboration with
586 the Office of Drug Control, shall study the feasibility of
587 enhancing the prescription drug validation program for the
588 purposes of public health initiatives and statistical reporting
589 that respects the privacy of the patient, the prescriber, and
590 the dispenser. Such a study shall be conducted in order to
591 further improve the quality of health care services and safety
592 by improving prescription drug prescribing practices, taking
593 advantage of advances in technology, reducing duplicative
594 prescriptions and the overprescribing of prescription drugs, and
595 reducing drug abuse. In addition, the direct-support
596 organization shall provide funding for the department, in
597 collaboration with the Office of Drug Control, to conduct
598 training for health care practitioners and other appropriate
599 persons in using the validation program to support the program
600 enhancements.
601 (14) A pharmacist, pharmacy, or dispensing health care
602 practitioner or his or her agent, before releasing a controlled
603 substance to any person not known to such dispenser, shall
604 require the person purchasing, receiving, or otherwise acquiring
605 the controlled substance to present valid photographic
606 identification or other verification of his or her identity to
607 the dispenser. If the person does not have proper
608 identification, the dispenser may verify the validity of the
609 prescription and the identity of the patient with the prescriber
610 or his or her authorized agent, or by a method determined by the
611 department, before dispensing the controlled substance. The
612 person purchasing, receiving, or otherwise acquiring the
613 controlled substance need not be the specific patient to whom
614 the prescription is prescribed. A record may be maintained for 2
615 years of the person acquiring the controlled substance, which
616 record shall include the person’s name and signature using the
617 proper identification. This subsection does not apply in an
618 institutional setting or to a long-term care facility,
619 including, but not limited to, an assisted living facility or a
620 hospital to which patients are admitted. As used in this
621 subsection, the term “proper identification” means a government
622 issued identification containing the person’s photograph,
623 printed name, and signature.
624 (15) The Agency for Health Care Administration shall
625 continue the implementation of electronic prescribing by health
626 care practitioners, health care facilities, and pharmacies under
627 s. 408.061 and the electronic prescribing clearinghouse
628 collaboration with the private sector under s. 408.0611.
629 (16) By October 1, 2010, the department shall adopt rules
630 pursuant to ss. 120.536(1) and 120.54 to administer the
631 provisions of this section.
632 Section 2. (1) The Program Implementation and Oversight
633 Task Force is created within the Executive Office of the
634 Governor. The director of the Office of Drug Control shall be a
635 nonvoting, ex officio member of the task force and shall act as
636 chair. The Office of Drug Control and the Department of Health
637 shall provide staff support for the task force.
638 (a) The following state officials shall serve on the task
639 force:
640 1. The Attorney General or his or her designee.
641 2. The Secretary of Children and Family Services or his or
642 her designee.
643 3. The Secretary of Health Care Administration or his or
644 her designee.
645 4. The State Surgeon General or his or her designee.
646 (b) In addition, the Governor shall appoint 10 members of
647 the public to serve on the task force. Of these 10 appointed
648 members, one member must have professional or occupational
649 expertise in computer security; one member must be a Florida
650 licensed, board-certified oncologist; two members must be
651 Florida-licensed, board-certified, fellowship-trained physicians
652 who have experience in pain management; one member must have
653 professional or occupational expertise in e-Prescribing or
654 prescription drug validation programs; one member must be a
655 Florida-licensed pharmacist; one member must have professional
656 or occupational expertise in the area of law enforcement and
657 have experience in prescription drug investigations; one member
658 must have professional or occupational expertise as an
659 epidemiologist and have a background in tracking and analyzing
660 drug trends; and two members must have professional or
661 occupational expertise as providers of substance abuse
662 treatment, with priority given to a member who is a former
663 substance abuser.
664 (c) Members appointed by the Governor shall be appointed to
665 a term of 3 years each. Any vacancy on the task force shall be
666 filled in the same manner as the original appointment, and any
667 member appointed to fill a vacancy shall serve only for the
668 unexpired term of the member’s predecessor.
669 (d) Members of the task force and members of subcommittees
670 appointed under subsection (4) shall serve without compensation,
671 but are entitled to reimbursement for per diem and travel
672 expenses as provided in s. 112.061, Florida Statutes.
673 (e) The task force shall meet at least quarterly or upon
674 the call of the chair.
675 (2) The purpose of the task force is to monitor the
676 implementation and safeguarding of the electronic system
677 established for the prescription drug validation program under
678 s. 893.055, Florida Statutes, and to ensure privacy, protection
679 of individual medication history, and the electronic system’s
680 appropriate use by physicians, dispensers, pharmacies, law
681 enforcement agencies, and those authorized to request
682 information from the electronic system.
683 (3) The Office of Drug Control shall submit a report to the
684 Governor, the President of the Senate, and the Speaker of the
685 House of Representatives by December 1 of each year which
686 contains a summary of the work of the task force during that
687 year and the recommendations developed in accordance with the
688 task force’s purpose as provided in subsection (2). Interim
689 reports may be submitted at the discretion of the chair.
690 (4) The chair of the task force may appoint subcommittees
691 that include members of state agencies that are not represented
692 on the task force for the purpose of soliciting input and
693 recommendations from those state agencies as needed by the task
694 force to accomplish its purpose as provided in subsection (2).
695 In addition, the chair may appoint subcommittees as necessary
696 from among the members of the task force in order to efficiently
697 address specific issues. If a state agency is to be represented
698 on any subcommittee, the representative shall be the head of the
699 agency or his or her designee. The chair may designate lead and
700 contributing agencies within a subcommittee.
701 (5) The task force shall provide a final report in
702 accordance with the task force’s purpose as provided in
703 subsection (2) on July 1, 2012, to the Governor, the President
704 of the Senate, and the Speaker of the House of Representatives.
705 Such report shall be prepared using only data that does not
706 identify a patient or dispenser. The task force shall expire and
707 this section is repealed on that date unless reenacted by the
708 Legislature.
709 Section 3. Subsections (4) is added to section 458.309,
710 Florida Statutes, to read:
711 458.309 Rulemaking authority.—
712 (4)(a) Each physician who practices in a privately owned
713 pain-management facility and who primarily engages in the
714 treatment of pain by prescribing narcotic medications or
715 controlled substance medications shall register the facility
716 with the department unless it is licensed as a facility under
717 chapter 395. The department shall inspect the facility annually
718 to ensure that it complies with board rules adopted by the board
719 pursuant to paragraph (b) unless the facility is accredited by a
720 nationally recognized accrediting agency approved by the board.
721 The actual costs for registration and inspection or
722 accreditation shall be paid by the physician seeking to register
723 the facility. For the purposes of this subsection, a physician
724 is primarily engaged in the treatment of pain by prescribing
725 controlled substance medications when the majority of patients
726 seen on any day the facility is open are issued controlled
727 substance prescriptions for the treatment of nonmalignant pain.
728 (b) The board shall adopt rules setting forth standards of
729 practice for physicians who practice in privately owned pain
730 management facilities and who primarily engage in the treatment
731 of pain by prescribing controlled substance medications. These
732 rules shall address, but need not be limited to, the following
733 subjects:
734 1. Facility operations.
735 2. Physical operations.
736 3. Infection control requirements.
737 4. Health and safety requirements.
738 5. Quality assurance requirements.
739 6. Patient records.
740 7. Training requirements for all facility health care
741 practitioners.
742 8. Inspections.
743 Section 4. Subsections (3) is added to section 459.005,
744 Florida Statutes, to read:
745 459.005 Rulemaking authority.—
746 (3)(a) Each osteopathic physician who practices in a
747 privately owned pain-management facility and who primarily
748 engages in the treatment of pain by prescribing narcotic
749 medications or controlled substance medications shall register
750 the facility with the department unless the facility is licensed
751 as a facility under chapter 395. The department shall inspect
752 the facility annually to ensure that it complies with board
753 rules adopted by the board pursuant to paragraph (b) unless the
754 facility is accredited by a nationally recognized accrediting
755 agency approved by the board. The actual costs for registration
756 and inspection or accreditation shall be paid by the physician
757 seeking to register the facility. For the purposes of this
758 subsection, an osteopathic physician is primarily engaged in the
759 treatment of pain by prescribing controlled substance
760 medications when the majority of patients seen on any day the
761 facility is open are issued controlled substance prescriptions
762 for the treatment of nonmalignant pain.
763 (b) The board shall adopt rules setting forth standards of
764 practice for osteopathic physicians who practice in privately
765 owned pain-management facilities and who primarily engage in the
766 treatment of pain by prescribing controlled substance
767 medications. These rules shall address, but need not be limited
768 to, the following subjects:
769 1. Facility operations.
770 2. Physical operations.
771 3. Infection control requirements.
772 4. Health and safety requirements.
773 5. Quality assurance requirements.
774 6. Patient records.
775 7. Training requirements for all facility health care
776 practitioners.
777 8. Inspections.
778 Section 5. This act shall take effect July 1, 2009.