CS/HB 897

1
A bill to be entitled
2An act relating to prescription drugs; creating s.
3893.055, F.S.; providing definitions; requiring the
4Department of Health to establish a comprehensive
5electronic database system to monitor the prescribing and
6dispensing of certain controlled substances; requiring
7specified prescribing and dispensing information to be
8reported to the electronic database system; requiring the
9department to establish policies and procedures for the
10system; requiring the department, upon receipt of certain
11funds and in coordination with the Office of Drug Control
12and specified organizations, to adopt rules appropriate
13for the prescription drug monitoring program; providing
14reporting requirements; providing a reporting period;
15providing exemptions from participation in the system;
16authorizing the department to establish when to suspend
17and when to resume reporting requirements during declared
18emergencies; requiring all nonexempt, dispensing
19pharmacists and practitioners to submit information in a
20specified format; providing that the cost to the dispenser
21in submitting the required information may not be material
22or extraordinary; specifying costs that are not material
23or extraordinary; providing access to information reported
24to the system under certain circumstances; providing that
25information in the database for the electronic
26prescription drug monitoring system is not discoverable or
27admissible in any civil or administrative action;
28providing exceptions; providing for the use of data for
29specified purposes; providing requirements for
30verification of information requested; requiring data
31transmission to comply with state and federal privacy and
32security laws; authorizing an agency or person to maintain
33the data for a specified period if the data is pertinent
34to ongoing health care or an active law enforcement
35investigation or prosecution; requiring the annual
36reporting of certain performance measures to the Governor
37and Legislature; providing performance measure criteria;
38providing criminal penalties for violations; requiring
39that all costs incurred by the department for the program
40be funded through federal grants or available private
41funding sources; providing requirements for seeking
42funding and procuring goods or services; authorizing the
43Office of Drug Control, in coordination with the
44department, to establish a direct-support organization;
45providing a definition; providing for a board of directors
46appointed by the director of the office; requiring the
47director to provide guidance to the board regarding
48acceptance of moneys from appropriate sources; requiring
49the direct-support organization to operate under written
50contract with the office; providing contract requirements;
51providing requirements for the direct-support
52organization's collecting, expending, and providing of
53funds; requiring department approval of activities of the
54direct-support organization; authorizing the office to
55adopt rules for the use of certain facilities and
56services; providing for audits; prohibiting the direct-
57support organization from exercising certain powers;
58establishing that a prescriber or dispenser is not liable
59for good faith use of the department-provided controlled
60substance prescription information of a patient; requiring
61the department, in collaboration with the office, to study
62the feasibility of enhancing the prescription drug
63monitoring program for specified purposes to the extent
64that funding is provided for such purpose; requiring
65certain persons to present specified identification in
66order to obtain controlled substances; providing for
67recordkeeping for certain transactions; requiring the
68Agency for Health Care Administration to continue the
69promotion of electronic prescribing and an electronic
70prescribing clearinghouse; requiring the department to
71adopt rules; establishing a Program Implementation and
72Oversight Task Force; providing for membership; providing
73for reimbursement of certain member expenses; providing
74for meetings; providing the purpose of the task force;
75requiring reports to the Governor and Legislature;
76providing for the creation, membership, and duties of
77subcommittees; authorizing the direct-support organization
78to collect, expend, and provide funds and other assistance
79to the department; providing for a final report and the
80termination of the task force; amending ss. 458.309 and
81459.005, F.S.; requiring certain physicians who engage in
82pain management to register their clinics with the
83department by a specified date; prohibiting certain
84physicians from practicing in a pain-management clinic
85that has not registered with the department; requiring the
86department to inspect each facility; providing for
87exceptions; requiring the physician seeking to register
88the clinic to pay the costs of registration and inspection
89or accreditation; requiring the Board of Medicine and the
90Board of Osteopathic Medicine to adopt rules setting forth
91standards of practice for certain physicians who engage in
92pain management; providing criteria for the rules;
93providing exceptions for certain clinics in which the
94majority of the physicians who provide services primarily
95provide surgical services; providing an effective date.
96
97     WHEREAS, as has been advocated by numerous pain management
98experts, addiction medicine experts, pharmacists, and law
99enforcement personnel, a prescription drug monitoring program
100that provides for reporting and advisory information and other
101specified information is established pursuant to this act to
102serve as a means to promote the public health and welfare and to
103detect and prevent controlled substance abuse and diversion, and
104     WHEREAS, while the importance and necessity of the proper
105prescribing, dispensing, and monitoring of controlled
106substances, particularly pain medication, have been established,
107controlled prescription drugs are too often diverted in this
108state, often through fraudulent means, including outright theft,
109phony pharmacy fronts, loose Internet medical evaluations, and
110inappropriate importation; in addition, there is a criminal
111element that facilitates the prescription drug abuse epidemic
112through illegal profitmaking from the diversion of certain
113controlled substances that are prescribed or dispensed by
114physicians, health care practitioners, and pharmacists, and
115     WHEREAS, in 2007, 8,620 drug-related deaths occurred in
116this state, 3,159 of which were caused by prescription drugs, an
117average of nearly 9 Floridians dying each day from prescription
118drugs; Schedule IV benzodiazepines, such as Xanax and Valium,
119were found to be present in more drug-related deaths than
120cocaine; and opiate pain medications were found to be
121contributing to increasing numbers of drug-related deaths, and
122     WHEREAS, pharmaceutical drug diversion hurts this state
123significantly in terms of lost lives, increased crime, human
124misery from addiction, and ballooning health care costs
125connected to treatment, medical expenses, and Medicaid fraud
126that all Floridians ultimately bear, and
127     WHEREAS, the intent of this act is not to interfere with
128the legitimate medical use of controlled substances; however,
129the people of this state are in need of and will benefit from a
130secure and privacy-protected statewide electronic system of
131specified prescription drug medication information created
132primarily to encourage safer controlled substance prescription
133decisions that reduce the number of prescription drug overdoses
134and the number of drug overdose deaths; to educate and inform
135health care practitioners and provide an added tool in patient
136care, including appropriate treatment for patients who have
137become addicted; to guide public health initiatives to educate
138the population on the dangers of misusing prescription drugs; to
139prevent the abuse or diversion of prescribed controlled
140substances; and to ensure that those who need prescribed
141controlled substances receive them in a manner that protects
142patient confidentiality, and
143     WHEREAS, while certain medicines are very helpful if
144properly prescribed to a patient in need and then used as
145prescribed, they may be dangerous or even deadly if improperly
146dispensed, misused, or diverted, and
147     WHEREAS, it is the intent of the Legislature to encourage
148patient safety, responsible pain management, and proper access
149to useful prescription drugs that are prescribed by a
150knowledgeable, properly licensed health care practitioner who
151dispenses prescription drugs and that are dispensed by a
152pharmacist who is made aware of the patient's prescription drug
153medication history, thus preventing, in some cases, an abuse or
154addiction problem from developing or worsening, making such a
155problem possible or easier to identify, and facilitating the
156order of appropriate medical treatment or referral, and
157     WHEREAS, such an electronic system will also aid
158administrative and law enforcement agencies in an active
159controlled substance-related investigation by facilitating
160decisions and recommendations for pursuing appropriate
161administrative or criminal justice actions while maintaining
162such information for any such investigation with a reasonable,
163good faith anticipation of securing an arrest or prosecution in
164the foreseeable future, and
165     WHEREAS, a Program Implementation and Oversight Task Force
166will provide information to the Governor and Legislature
167regarding the implementation of the program and ensure that
168privacy and confidentiality of the patient's prescription
169history is respected, NOW, THEREFORE,
170
171Be It Enacted by the Legislature of the State of Florida:
172
173     Section 1.  Section 893.055, Florida Statutes, is created
174to read:
175     893.055  Prescription drug monitoring program.--
176     (1)  As used in this section, the term:
177     (a)  "Active investigation" means an investigation that is
178being conducted with a reasonable, good faith belief that it
179could lead to the filing of administrative, civil, or criminal
180proceedings, or that is ongoing and continuing and for which
181there is a reasonable, good faith anticipation of securing an
182arrest or prosecution in the foreseeable future.
183     (b)  "Controlled substance" means a controlled substance
184listed in Schedule II, Schedule III, or Schedule IV in s.
185893.03.
186     (c)  "Dispenser" means a pharmacy, dispensing pharmacist,
187or dispensing health care practitioner.
188     (d)  "Health care practitioner" or "practitioner" means any
189practitioner who is subject to licensure or regulation by the
190department under chapter 458, chapter 459, chapter 461, chapter
191462, chapter 464, chapter 465, or chapter 466.
192     (e)  "Health care regulatory board" means any board for a
193practitioner or health care practitioner who is licensed or
194regulated by the department.
195     (f)  "Law enforcement agency" means the Department of Law
196Enforcement, a Florida sheriff's department, a Florida police
197department, or a law enforcement agency of the Federal
198Government which enforces the laws of this state or the United
199States relating to controlled substances and the agents and
200officers of which are empowered by law to conduct criminal
201investigations and make arrests.
202     (g)  "Patient advisory report" or "advisory report" means
203information provided by the department in writing, or as
204determined by the department, to a prescriber, dispenser,
205pharmacy, or patient concerning the dispensing of controlled
206substances. All advisory reports are for informational purposes
207only and impose no obligations of any nature or any legal duty
208on a prescriber, dispenser, pharmacy, or patient. The patient
209advisory report shall be provided in accordance with s.
210893.13(7)(a)8. The advisory reports issued by the department are
211not subject to discovery or introduction into evidence in any
212civil or administrative action against a prescriber, dispenser,
213pharmacy, or patient arising out of matters that are the subject
214of the report, and a person who participates in preparing,
215reviewing, issuing, or any other activity related to an advisory
216report may not be permitted or required to testify in any such
217civil action as to any findings, recommendations, evaluations,
218opinions, or other actions taken in connection with preparing,
219reviewing, or issuing such a report.
220     (h)  "Pharmacy" means any pharmacy that is subject to
221licensure or regulation by the department under chapter 465 and
222that dispenses or delivers a controlled substance to an
223individual or address in this state.
224     (i)  "Prescriber" means a prescribing physician,
225prescribing practitioner, or other prescribing health care
226practitioner.
227     (2)(a)  By December 1, 2010, the department shall design
228and establish a comprehensive electronic database system that
229has controlled substance prescriptions provided to it and that
230provides prescription information to a patient's health care
231practitioner and pharmacist who inform the department that they
232wish the patient advisory report provided to them. Otherwise,
233the patient advisory report will not be sent to the
234practitioner, pharmacy, or pharmacist. The system shall be
235designed to provide information regarding dispensed
236prescriptions of controlled substances and shall not infringe
237upon the legitimate prescribing or dispensing of a controlled
238substance by a prescriber or dispenser acting in good faith and
239in the course of professional practice. The system shall be
240consistent with standards of the American Society for Automation
241in Pharmacy (ASAP). The electronic system shall also comply with
242the Health Insurance Portability and Accountability Act (HIPAA)
243as it pertains to protected health information (PHI), electronic
244protected health information (EPHI), and all other relevant
245state and federal privacy and security laws and regulations. The
246department shall establish policies and procedures as
247appropriate regarding the reporting, accessing, evaluation,
248management, development, implementation, operation, storage, and
249security of information within the system. The reporting of
250prescribed controlled substances shall include a dispensing
251transaction with a dispenser pursuant to chapter 465 or through
252a dispensing transaction to an individual or address in this
253state with a pharmacy that is not located in this state but that
254is otherwise subject to the jurisdiction of this state as to
255that dispensing transaction. The reporting of patient advisory
256reports refers only to reports to patients, pharmacies, and
257practitioners. Separate reports that contain patient
258prescription history information and that are not patient
259advisory reports are provided to persons and entities as
260authorized in paragraphs (7)(b) and (c) and s. 893.0551.
261     (b)  The department, when the direct support organization
262receives at least $20,000 in nonstate moneys or the state
263receives at least $20,000 in federal grants for the prescription
264drug monitoring program, and in coordination with the Office of
265Drug Control, shall adopt rules as necessary concerning the
266reporting, accessing, evaluation, management, development,
267implementation, operation, security, and storage of information
268within the system, including rules for when patient advisory
269reports are provided to pharmacies and prescribers. The patient
270advisory report shall be provided in accordance with s.
271893.13(7)(a)8. The department shall work with the professional
272health care licensure boards, such as the Board of Medicine, the
273Board of Osteopathic Medicine, and the Board of Pharmacy; other
274appropriate organizations, such as the Florida Pharmacy
275Association, the Office of Drug Control, the Florida Medical
276Association, the Florida Retail Federation, and the Florida
277Osteopathic Medical Association, including those relating to
278pain management; and the Attorney General, the Department of Law
279Enforcement, and the Agency for Health Care Administration to
280develop rules appropriate for the prescription drug monitoring
281program.
282     (c)  All dispensers and prescribers subject to these
283reporting requirements shall be notified by the department of
284the implementation date for such reporting requirements.
285     (3)  The pharmacy dispensing the controlled substance and
286each prescriber who directly dispenses a controlled substance
287shall submit to the electronic system, by a procedure and in a
288format established by the department and consistent with an
289ASAP-approved format, the following information for inclusion in
290the database:
291     (a)  The name of the prescribing practitioner, the
292practitioner's federal Drug Enforcement Administration
293registration number, the practitioner's National Provider
294Identification (NPI) or other appropriate identifier, and the
295date of the prescription.
296     (b)  The date the prescription was filled and the method of
297payment, such as cash by an individual, insurance coverage
298through a third party, or Medicaid payment. This paragraph does
299not authorize the department to include individual credit card
300numbers or other account numbers in the database.
301     (c)  The full name, address, and date of birth of the
302person for whom the prescription was written.
303     (d)  The name, national drug code, quantity, and strength
304of the controlled substance dispensed.
305     (e)  The full name, federal Drug Enforcement Administration
306registration number, and address of the pharmacy or other
307location from which the controlled substance was dispensed. If
308the controlled substance was dispensed by a practitioner other
309than a pharmacist, the practitioner's full name, federal Drug
310Enforcement Administration registration number, and address.
311     (f)  The name of the pharmacy or practitioner, other than a
312pharmacist, dispensing the controlled substance and the
313practitioner's National Provider Identification (NPI).
314     (g)  Other appropriate identifying information as
315determined by department rule.
316     (4)  Each time a controlled substance is dispensed to an
317individual, the controlled substance shall be reported to the
318department through the system as soon thereafter as possible,
319but not more than 15 days after the date the controlled
320substance is dispensed unless an extension is approved by the
321department for cause as determined by rule. A dispenser must
322meet the reporting requirements of this section by providing the
323required information concerning each controlled substance that
324it dispensed in a department-approved, secure methodology and
325format. Such approved methodologies and formats may include, but
326are not limited to, submission via the Internet, on a disc, or
327by use of regular mail.
328     (5)  When the following acts of dispensing or administering
329occur, the following are exempt from reporting under this
330section as to that specific act of dispensing or administration:
331     (a)  A health care practitioner when administering a
332controlled substance directly to a patient if the amount of the
333controlled substance is adequate to treat the patient during
334that particular treatment session.
335     (b)  A pharmacist or health care practitioner when
336administering a controlled substance to a patient or resident
337receiving care as a patient at a hospital, nursing home,
338ambulatory surgical center, hospice, or intermediate care
339facility for the developmentally disabled which is licensed in
340this state.
341     (c)  A practitioner when administering or dispensing a
342controlled substance in the health care system of the Department
343of Corrections.
344     (d)  A practitioner when administering a controlled
345substance in the emergency room of a licensed hospital.
346     (e)  A health care practitioner when administering or
347dispensing a controlled substance to a person under the age of
34816.
349     (f)  A pharmacist or a dispensing practitioner when
350dispensing a one-time, 72-hour emergency resupply of a
351controlled substance to a patient.
352     (6)  The department may establish when to suspend and when
353to resume reporting information during a state-declared or
354nationally declared disaster.
355     (7)(a)  A practitioner or pharmacist who dispenses a
356controlled substance must submit the information required by
357this section in an electronic or other method in an ASAP format
358approved by rule of the department unless otherwise provided in
359this section. The cost to the dispenser in submitting the
360information required by this section may not be material or
361extraordinary. Costs not considered to be material or
362extraordinary include, but are not limited to, regular postage,
363electronic media, regular electronic mail, and facsimile
364charges.
365     (b)  A pharmacy, prescriber, or dispenser shall have access
366to information in the prescription drug monitoring program's
367database which relates to a patient of that pharmacy,
368prescriber, or dispenser in a manner established by the
369department as needed for the purpose of reviewing the patient's
370controlled substance prescription history. Other access to the
371program's database shall be limited to the program's manager and
372to the designated program and support staff, who may act only at
373the direction of the program manager or, in the absence of the
374program manager, as authorized. Access by the program manager or
375such designated staff is for prescription drug program
376management only or for management of the program's database and
377its system in support of the requirements of this section and in
378furtherance of the prescription drug monitoring program.
379Confidential and exempt information in the database shall be
380released only as provided in paragraph (c) and s. 893.0551.
381     (c)  The following entities shall not be allowed direct
382access to information in the prescription drug monitoring
383program database but may request from the program manager and,
384when authorized by the program manager, the program manager's
385program and support staff, information that is confidential and
386exempt under s. 893.0551. Prior to release, the request shall be
387verified as authentic and authorized with the requesting
388organization by the program manager, the program manager's
389program and support staff, or as determined in rules by the
390department as being authentic and as having been authorized by
391the requesting entity:
392     1.  The department or its relevant health care regulatory
393boards responsible for the licensure, regulation, or discipline
394of practitioners, pharmacists, or other persons who are
395authorized to prescribe, administer, or dispense controlled
396substances and who are involved in a specific controlled
397substance investigation involving a designated person for one or
398more prescribed controlled substances.
399     2.  The Attorney General for Medicaid fraud cases involving
400prescribed controlled substances.
401     3.  A law enforcement agency during active investigations
402regarding potential criminal activity, fraud, or theft regarding
403prescribed controlled substances.
404     4.  A patient or the legal guardian or designated health
405care surrogate of an incapacitated patient as described in s.
406893.0551 who, for the purpose of verifying the accuracy of the
407database information, submits a written and notarized request
408that includes the patient's full name, address, and date of
409birth, and includes the same information if the legal guardian
410or health care surrogate submits the request. The request shall
411be validated by the department to verify the identity of the
412patient and the legal guardian or health care surrogate, if the
413patient's legal guardian or health care surrogate is the
414requestor. Such verification is also required for any request to
415change a patient's prescription history or other information
416related to his or her information in the electronic database.
417
418Information in the database for the electronic prescription drug
419monitoring system is not discoverable or admissible in any civil
420or administrative action, except in an investigation and
421disciplinary proceeding by the department or the appropriate
422regulatory board.
423     (d)  The following entities shall not be allowed direct
424access to information in the prescription drug monitoring
425program database but may request from the program manager and,
426when authorized by the program manager, the program manager's
427program and support staff information that contains no
428identifying information of any patient, physician, health care
429practitioner, prescriber, or dispenser and that is not
430confidential and exempt:
431     1.  Department staff for the purpose of calculating
432performance measures pursuant to subsection (8).
433     2.  The Program Implementation and Oversight Task Force for
434its reporting to the Governor, the President of the Senate, and
435the Speaker of the House of Representatives regarding the
436prescription drug monitoring program. This subparagraph expires
437July 1, 2012.
438     (e)  All transmissions of data required by this section
439must comply with relevant state and federal privacy and security
440laws and regulations. However, any authorized agency or person
441under s. 893.0551 receiving such information as allowed by s.
442893.0551 may maintain the information received for up to 24
443months before purging it from his or her records or maintain it
444for longer than 24 months if the information is pertinent to
445ongoing health care or an active law enforcement investigation
446or prosecution.
447     (8)  To assist in fulfilling program responsibilities,
448performance measures shall be reported annually to the Governor,
449the President of the Senate, and the Speaker of the House of
450Representatives by the department each December 1, beginning in
4512011. Data that does not contain patient, physician, health care
452practitioner, prescriber, or dispenser identifying information
453may be requested during the year by department employees so that
454the department may undertake public health care and safety
455initiatives that take advantage of observed trends. Performance
456measures may include, but are not limited to, efforts to achieve
457the following outcomes:
458     (a)  Reduction of the rate of inappropriate use of
459prescription drugs through department education and safety
460efforts.
461     (b)  Reduction of the quantity of pharmaceutical controlled
462substances obtained by individuals attempting to engage in fraud
463and deceit.
464     (c)  Increased coordination among partners participating in
465the prescription drug monitoring program.
466     (d)  Involvement of stakeholders in achieving improved
467patient health care and safety and reduction of prescription
468drug abuse and prescription drug diversion.
469     (9)  Any person who willfully and knowingly fails to report
470the dispensing of a controlled substance as required by this
471section commits a misdemeanor of the first degree, punishable as
472provided in s. 775.082 or s. 775.083.
473     (10)  All costs incurred by the department in administering
474the prescription drug monitoring program shall be funded through
475federal grants or private funding applied for or received by the
476state. The department may not commit funds for the monitoring
477program without ensuring funding is available. The prescription
478drug monitoring program and the implementation thereof are
479contingent upon receipt of the nonstate funding. The department
480and state government shall cooperate with the direct-support
481organization established pursuant to subsection (11) in seeking
482federal grant funds, other nonstate grant funds, gifts,
483donations, or other private moneys for the department so long as
484the costs of doing so are not considered material. Nonmaterial
485costs for this purpose include, but are not limited to, the
486costs of mailing and personnel assigned to research or apply for
487a grant. Notwithstanding the exemptions to competitive-
488solicitation requirements under s. 287.057(5)(f), the department
489shall comply with the competitive-solicitation requirements
490under s. 287.057 for the procurement of any goods or services
491required by this section.
492     (11)  The Office of Drug Control, in coordination with the
493department, may establish a direct-support organization that has
494a board consisting of at least five members to provide
495assistance, funding, and promotional support for the activities
496authorized for the prescription drug monitoring program.
497     (a)  As used in this subsection, the term "direct-support
498organization" means an organization that is:
499     1.  A Florida corporation not for profit incorporated under
500chapter 617, exempted from filing fees, and approved by the
501Department of State.
502     2.  Organized and operated to conduct programs and
503activities; raise funds; request and receive grants, gifts, and
504bequests of money; acquire, receive, hold, and invest, in its
505own name, securities, funds, objects of value, or other
506property, either real or personal; and make expenditures or
507provide funding to or for the direct or indirect benefit of the
508department in the furtherance of the prescription drug
509monitoring program.
510     (b)  The direct-support organization is not considered a
511lobbying firm within the meaning of s. 11.045.
512     (c)  The director of the Office of Drug Control shall
513appoint a board of directors for the direct-support
514organization. The director may designate employees of the Office
515of Drug Control, state employees other than state employees from
516the department, and any other nonstate employees, as
517appropriate, to serve on the board. Members of the board shall
518serve at the pleasure of the director of the Office of Drug
519Control. The director shall provide guidance to members of the
520board to ensure that moneys received by the direct-support
521organization are not received from inappropriate sources.
522Inappropriate sources include, but are not limited to, donors,
523grantors, persons, or organizations that may monetarily or
524substantively benefit from the purchase of goods or services by
525the department in furtherance of the prescription drug
526monitoring program.
527     (d)  The direct-support organization shall operate under
528written contract with the Office of Drug Control. The contract
529must, at a minimum, provide for:
530     1.  Approval of the articles of incorporation and bylaws of
531the direct-support organization by the Office of Drug Control.
532     2.  Submission of an annual budget for the approval of the
533Office of Drug Control.
534     3.  Certification by the Office of Drug Control in
535consultation with the department that the direct-support
536organization is complying with the terms of the contract in a
537manner consistent with and in furtherance of the goals and
538purposes of the prescription drug monitoring program and in the
539best interests of the state. Such certification must be made
540annually and reported in the official minutes of a meeting of
541the direct-support organization.
542     4.  The reversion, without penalty, to the Office of Drug
543Control, or to the state if the Office of Drug Control ceases to
544exist, of all moneys and property held in trust by the direct-
545support organization for the benefit of the prescription drug
546monitoring program if the direct-support organization ceases to
547exist or if the contract is terminated.
548     5.  The fiscal year of the direct-support organization,
549which must begin July 1 of each year and end June 30 of the
550following year.
551     6.  The disclosure of the material provisions of the
552contract to donors of gifts, contributions, or bequests,
553including such disclosure on all promotional and fundraising
554publications, and an explanation to such donors of the
555distinction between the Office of Drug Control and the direct-
556support organization.
557     7.  The direct-support organization's collecting,
558expending, and providing of funds to the department for the
559development, implementation, and operation of the prescription
560drug monitoring program as described in this section and for the
561Program Implementation and Oversight Task Force under section 2
562of this act as long as the task force is authorized. The direct-
563support organization may collect and expend funds to be used for
564the functions of the direct-support organization's board of
565directors, as necessary and approved by the director of the
566Office of Drug Control. In addition, the direct-support
567organization may collect and provide funding to the department
568in furtherance of the prescription drug monitoring program by:
569     a.  Establishing and administering the prescription drug
570monitoring program's electronic database, including hardware and
571software.
572     b.  Conducting studies on the efficiency and effectiveness
573of the program to include feasibility studies as described in
574subsection (13).
575     c.  Providing funds for future enhancements of the program
576within the intent of this section.
577     d.  Providing user training of the prescription drug
578monitoring program, including distribution of materials to
579promote public awareness and education and conducting workshops
580or other meetings, for health care practitioners, pharmacists,
581and others as appropriate.
582     e.  Providing funds for travel expenses.
583     f.  Providing funds for administrative costs, including
584personnel, audits, facilities, and equipment.
585     g.  Fulfilling all other requirements necessary to
586implement and operate the program as outlined in this section.
587     (e)  The activities of the direct-support organization must
588be consistent with the goals and mission of the Office of Drug
589Control, as determined by the office in consultation with the
590department, and in the best interests of the state. The direct-
591support organization must obtain a written approval from the
592director of the Office of Drug Control for any activities in
593support of the prescription drug monitoring program before
594undertaking those activities.
595     (f)  The Office of Drug Control, in consultation with the
596department, may permit, without charge, appropriate use of
597administrative services, property, and facilities of the Office
598of Drug Control and the department by the direct-support
599organization, subject to this section. The use must be directly
600in keeping with the approved purposes of the direct-support
601organization and may not be made at times or places that would
602unreasonably interfere with opportunities for the public to use
603such facilities for established purposes. Any moneys received
604from rentals of facilities and properties managed by the Office
605of Drug Control and the department may be held by the Office of
606Drug Control or in a separate depository account in the name of
607the direct-support organization and subject to the provisions of
608the letter of agreement with the Office of Drug Control. The
609letter of agreement must provide that any funds held in the
610separate depository account in the name of the direct-support
611organization must revert to the Office of Drug Control if the
612direct-support organization is no longer approved by the Office
613of Drug Control to operate in the best interests of the state.
614     (g)  The Office of Drug Control, in consultation with the
615department, may adopt rules under s. 120.54 to govern the use of
616administrative services, property, or facilities of the
617department or office by the direct-support organization.
618     (h)  The Office of Drug Control may not permit the use of
619any administrative services, property, or facilities of the
620state by a direct-support organization if that organization does
621not provide equal membership and employment opportunities to all
622persons regardless of race, color, religion, gender, age, or
623national origin.
624     (i)  The direct-support organization shall provide for an
625independent annual financial audit in accordance with s.
626215.981. Copies of the audit shall be provided to the Office of
627Drug Control and the Office of Policy and Budget in the
628Executive Office of the Governor.
629     (j)  The direct-support organization may not exercise any
630power under s. 617.0302(12) or (16).
631     (12)  A prescriber or dispenser may have access to the
632information under this section which relates to a patient of
633that prescriber or dispenser as needed for the purpose of
634reviewing the patient's controlled drug prescription history. A
635prescriber or dispenser acting in good faith is immune from any
636civil, criminal, or administrative liability that might
637otherwise be incurred or imposed for receiving or using
638information from the prescription drug monitoring program. This
639subsection does not create a private cause of action, and a
640person may not recover damages against a prescriber or dispenser
641authorized to access information under this subsection for
642accessing or failing to access such information.
643     (13)  To the extent that funding is provided for such
644purpose through federal or private grants or gifts and other
645types of available moneys, the department, in collaboration with
646the Office of Drug Control, shall study the feasibility of
647enhancing the prescription drug monitoring program for the
648purposes of public health initiatives and statistical reporting
649that respects the privacy of the patient, the prescriber, and
650the dispenser. Such a study shall be conducted in order to
651further improve the quality of health care services and safety
652by improving the prescribing and dispensing practices for
653prescription drugs, taking advantage of advances in technology,
654reducing duplicative prescriptions and the overprescribing of
655prescription drugs, and reducing drug abuse. The requirements of
656the National All Schedules Prescription Electronic Reporting
657(NASPER) Act are authorized in order to apply for federal NASPER
658funding. In addition, the direct-support organization shall
659provide funding for the department, in collaboration with the
660Office of Drug Control, to conduct training for health care
661practitioners and other appropriate persons in using the
662monitoring program to support the program enhancements.
663     (14)  A pharmacist, pharmacy, or dispensing health care
664practitioner or his or her agent, before releasing a controlled
665substance to any person not known to such dispenser, shall
666require the person purchasing, receiving, or otherwise acquiring
667the controlled substance to present valid photographic
668identification or other verification of his or her identity to
669the dispenser. If the person does not have proper
670identification, the dispenser may verify the validity of the
671prescription and the identity of the patient with the prescriber
672or his or her authorized agent. Verification of health plan
673eligibility through a real-time inquiry or adjudication system
674will be considered to be proper identification. This subsection
675does not apply in an institutional setting or to a long-term
676care facility, including, but not limited to, an assisted living
677facility or a hospital to which patients are admitted. As used
678in this subsection, the term "proper identification" means an
679identification that is issued by a state or the Federal
680Government containing the person's photograph, printed name, and
681signature or a document considered acceptable under 8 C.F.R. s.
682274a.2(b)(1)(v)(A) and (B).
683     (15)  The Agency for Health Care Administration shall
684continue the promotion of electronic prescribing by health care
685practitioners, health care facilities, and pharmacies under s.
686408.0611.
687     (16)  By October 1, 2010, the department shall adopt rules
688pursuant to ss. 120.536(1) and 120.54 to administer the
689provisions of this section, which shall include as necessary the
690reporting, accessing, evaluation, management, development,
691implementation, operation, and storage of information within the
692monitoring program's system.
693     Section 2.  (1)  The Program Implementation and Oversight
694Task Force is created within the Executive Office of the
695Governor. The director of the Office of Drug Control shall be a
696nonvoting, ex officio member of the task force and shall act as
697chair. The Office of Drug Control and the Department of Health
698shall provide staff support for the task force.
699     (a)  The following state officials shall serve on the task
700force:
701     1.  The Attorney General or his or her designee.
702     2.  The Secretary of Children and Family Services or his or
703her designee.
704     3.  The Secretary of Health Care Administration or his or
705her designee.
706     4.  The State Surgeon General or his or her designee.
707     (b)  In addition, the Governor shall appoint 12 members of
708the public to serve on the task force. Of these 12 appointed
709members, one member must have professional or occupational
710expertise in computer security; one member must be a Florida-
711licensed, board-certified oncologist; two members must be
712Florida-licensed, fellowship-trained, pain-medicine physicians;
713one member must be a Florida-licensed primary care physician who
714has experience in prescribing scheduled prescription drugs; one
715member must have professional or occupational expertise in e-
716Prescribing or prescription drug monitoring programs; two
717members must be Florida-licensed pharmacists; one member must
718have professional or occupational expertise in the area of law
719enforcement and have experience in prescription drug
720investigations; one member must have professional or
721occupational expertise as an epidemiologist and have a
722background in tracking and analyzing drug trends; and two
723members must have professional or occupational expertise as
724providers of substance abuse treatment, with priority given to a
725member who is a former substance abuser.
726     (c)  Members appointed by the Governor shall be appointed
727to a term of 3 years each. Any vacancy on the task force shall
728be filled in the same manner as the original appointment, and
729any member appointed to fill a vacancy shall serve only for the
730unexpired term of the member's predecessor.
731     (d)  Members of the task force and members of subcommittees
732appointed under subsection (4) shall serve without compensation,
733but are entitled to reimbursement for per diem and travel
734expenses as provided in s. 112.061, Florida Statutes.
735     (e)  The task force shall meet at least quarterly or upon
736the call of the chair.
737     (2)  The purpose of the task force is to monitor the
738implementation and safeguarding of the electronic system
739established for the prescription drug monitoring program under
740s. 893.055, Florida Statutes, and to ensure privacy, protection
741of individual medication history, and the electronic system's
742appropriate use by physicians, dispensers, pharmacies, law
743enforcement agencies, and those authorized to request
744information from the electronic system.
745     (3)  The Office of Drug Control shall submit a report to
746the Governor, the President of the Senate, and the Speaker of
747the House of Representatives by December 1 of each year which
748contains a summary of the work of the task force during that
749year and the recommendations developed in accordance with the
750task force's purpose as provided in subsection (2). Interim
751reports may be submitted at the discretion of the chair.
752     (4)  The chair of the task force may appoint subcommittees
753that include members of state agencies that are not represented
754on the task force for the purpose of soliciting input and
755recommendations from those state agencies as needed by the task
756force to accomplish its purpose as provided in subsection (2).
757In addition, the chair may appoint subcommittees as necessary
758from among the members of the task force in order to efficiently
759address specific issues. If a state agency is to be represented
760on any subcommittee, the representative shall be the head of the
761agency or his or her designee. The chair may designate lead and
762contributing agencies within a subcommittee.
763     (5)  The direct-support organization created in s. 893.055,
764Florida Statutes, may collect, expend, and provide funds and
765other assistance to the department for the development,
766implementation, and operation of the task force.
767     (6)  The task force shall provide a final report in
768accordance with the task force's purpose as provided in
769subsection (2) on July 1, 2012, to the Governor, the President
770of the Senate, and the Speaker of the House of Representatives.
771Such report shall be prepared using only data that does not
772identify a patient, a prescriber, or a dispenser. The task force
773shall expire and this section is repealed on that date unless
774reenacted by the Legislature.
775     Section 3.  Subsections (4), (5), and (6) are added to
776section 458.309, Florida Statutes, to read:
777     458.309  Rulemaking authority.--
778     (4)  All privately owned pain-management clinics,
779facilities, or offices, hereinafter referred to as "clinics,"
780which advertise in any medium for any type of pain-management
781services, or employ a physician who is primarily engaged in the
782treatment of pain by prescribing or dispensing controlled
783substance medications, must register with the department by
784January 4, 2010, unless that clinic is licensed as a facility
785pursuant to chapter 395. A physician may not practice medicine
786in a pain-management clinic that is required to but has not
787registered with the department. Each clinic location shall be
788registered separately regardless of whether the clinic is
789operated under the same business name or management as another
790clinic. If the clinic is licensed as a health care clinic under
791chapter 400, the medical director is responsible for registering
792the facility with the department. If the clinic is not
793registered pursuant to chapter 395 or chapter 400, the clinic
794shall, upon registration with the department, designate a
795physician who is responsible for complying with all requirements
796related to registration of the clinic. The designated physician
797shall be licensed under this chapter or chapter 459 and shall
798practice at the office location for which the physician has
799assumed responsibility. The department shall inspect the clinic
800annually to ensure that it complies with rules of the Board of
801Medicine adopted pursuant to this subsection and subsection (5)
802unless the office is accredited by a nationally recognized
803accrediting agency approved by the Board of Medicine. The actual
804costs for registration and inspection or accreditation shall be
805paid by the physician seeking to register the clinic.
806     (5)  The Board of Medicine shall adopt rules setting forth
807standards of practice for physicians practicing in privately
808owned pain-management clinics that primarily engage in the
809treatment of pain by prescribing or dispensing controlled
810substance medications. Such rules shall address, but need not be
811limited to, the following subjects:
812     (a)  Facility operations;
813     (b)  Physical operations;
814     (c)  Infection control requirements;
815     (d)  Health and safety requirements;
816     (e)  Quality assurance requirements;
817     (f)  Patient records;
818     (g)  Training requirements for all facility health care
819practitioners who are not regulated by another board;
820     (h)  Inspections; and
821     (i)  Data collection and reporting requirements.
822
823A physician is primarily engaged in the treatment of pain by
824prescribing or dispensing controlled substance medications when
825the majority of the patients seen are prescribed or dispensed
826controlled substance medications for the treatment of chronic
827nonmalignant pain. Chronic nonmalignant pain is pain unrelated
828to cancer which persists beyond the usual course of the disease
829or the injury that is the cause of the pain or more than 90 days
830after surgery.
831     (6)  A privately owned clinic, facility, or office that
832advertises in any medium for any type of pain-management
833services or employs one or more physicians who are primarily
834engaged in the treatment of pain by prescribing or dispensing
835controlled substances is exempt from the registration provisions
836in subsection (4) if the majority of the physicians who provide
837services in the clinic, facility, or office primarily provide
838surgical services.
839     Section 4.  Subsections (3), (4), and (5) are added to
840section 459.005, Florida Statutes, to read:
841     459.005  Rulemaking authority.--
842     (3)  All privately owned pain-management clinics,
843facilities, or offices, hereinafter referred to as "clinics,"
844which advertise in any medium for any type of pain-management
845services, or employ a physician who is licensed under this
846chapter and who is primarily engaged in the treatment of pain by
847prescribing or dispensing controlled substance medications, must
848register with the department by January 4, 2010, unless that
849clinic is licensed as a facility under chapter 395. A physician
850may not practice osteopathic medicine in a pain-management
851clinic that is required to but has not registered with the
852department. Each clinic location shall be registered separately
853regardless of whether the clinic is operated under the same
854business name or management as another clinic. If the clinic is
855licensed as a health care clinic under chapter 400, the medical
856director is responsible for registering the facility with the
857department. If the clinic is not registered under chapter 395 or
858chapter 400, the clinic shall, upon registration with the
859department, designate a physician who is responsible for
860complying with all requirements related to registration of the
861clinic. The designated physician shall be licensed under chapter
862458 or this chapter and shall practice at the office location
863for which the physician has assumed responsibility. The
864department shall inspect the clinic annually to ensure that it
865complies with rules of the Board of Osteopathic Medicine adopted
866pursuant to this subsection and subsection (4) unless the office
867is accredited by a nationally recognized accrediting agency
868approved by the Board of Osteopathic Medicine. The actual costs
869for registration and inspection or accreditation shall be paid
870by the physician seeking to register the clinic.
871     (4)  The Board of Osteopathic Medicine shall adopt rules
872setting forth standards of practice for physicians who practice
873in privately owned pain-management clinics that primarily engage
874in the treatment of pain by prescribing or dispensing controlled
875substance medications. Such rules shall address, but need not be
876limited to, the following subjects:
877     (a)  Facility operations;
878     (b)  Physical operations;
879     (c)  Infection control requirements;
880     (d)  Health and safety requirements;
881     (e)  Quality assurance requirements;
882     (f)  Patient records;
883     (g)  Training requirements for all facility health care
884practitioners who are not regulated by another board;
885     (h)  Inspections; and
886     (i)  Data collection and reporting requirements.
887
888A physician is primarily engaged in the treatment of pain by
889prescribing or dispensing controlled substance medications when
890the majority of the patients seen are prescribed or dispensed
891controlled substance medications for the treatment of chronic
892nonmalignant pain. Chronic nonmalignant pain is pain unrelated
893to cancer which persists beyond the usual course of the disease
894or the injury that is the cause of the pain or more than 90 days
895after surgery.
896     (5)  A privately owned clinic, facility, or office that
897advertises in any medium for any type of pain-management
898services or employs one or more physicians who are primarily
899engaged in the treatment of pain by prescribing or dispensing
900controlled substances is exempt from the registration provisions
901in subsection (3) if the majority of the physicians who provide
902services in the clinic, facility, or office primarily provide
903surgical services.
904     Section 5.  This act shall take effect July 1, 2009.


CODING: Words stricken are deletions; words underlined are additions.