Bill Text: FL S0862 | 2014 | Regular Session | Comm Sub
Bill Title: Prescription Drug Monitoring
Spectrum: Committee Bill
Status: (Failed) 2014-05-02 - Died in Messages, companion bill(s) passed, see HB 7177 (Ch. 2014-156), CS/SB 1194 (Ch. 2014-96) [S0862 Detail]
Download: Florida-2014-S0862-Comm_Sub.html
Florida Senate - 2014 CS for SB 862
By the Committees on Judiciary; and Health Policy
590-03524-14 2014862c1
1 A bill to be entitled
2 An act relating to prescription drug monitoring;
3 amending s. 893.055, F.S.; defining and redefining
4 terms; revising provisions relating to the
5 comprehensive electronic database system and
6 prescription drug monitoring program maintained by the
7 Department of Health; allowing impaired practitioner
8 consultants retained by the department access to
9 certain information; providing requirements for the
10 release of information shared with a state attorney in
11 response to a discovery demand; providing procedures
12 for the release of information to a law enforcement
13 agency during an active investigation; requiring the
14 department to adopt a user agreement by rule;
15 requiring the department to enter into a user
16 agreement with the law enforcement agency requesting
17 the release of information; providing requirements for
18 the user agreement; requiring a law enforcement agency
19 under a user agreement to conduct annual audits;
20 providing for the restriction, suspension, or
21 termination of a user agreement; providing for access
22 to the program database by the program manager and
23 designated support staff; authorizing the department
24 to provide a patient advisory report to the
25 appropriate health care practitioner if the program
26 manager determines that a specified pattern exists;
27 authorizing the department to provide relevant
28 information that does not contain personal identifying
29 information to a law enforcement agency if the program
30 manager determines that a specified pattern exists;
31 authorizing the law enforcement agency to use such
32 information to determine whether an active
33 investigation is warranted; authorizing the department
34 to fund the program with up to $500,000 of funds
35 generated under ch. 465, F.S.; authorizing the
36 department to seek federal or private funds to support
37 the program; repealing language creating a direct
38 support organization to fund the program; deleting
39 obsolete provisions; providing an effective date.
40
41 Be It Enacted by the Legislature of the State of Florida:
42
43 Section 1. Section 893.055, Florida Statutes, is amended to
44 read:
45 893.055 Prescription drug monitoring program.—
46 (1) As used in this section, the term:
47 (a) “Patient advisory report” or “advisory report” means
48 information provided by the department in writing, or as
49 determined by the department, to a prescriber, dispenser,
50 pharmacy, or patient concerning the dispensing of controlled
51 substances. All Advisory reports are for informational purposes
52 only and do not impose any obligation no obligations of any
53 nature or any legal duty on a prescriber, dispenser, pharmacy,
54 or patient. An advisory report The patient advisory report shall
55 be provided in accordance with s. 893.13(7)(a)8. The advisory
56 reports issued by the department is are not subject to discovery
57 or introduction into evidence in a any civil or administrative
58 action against a prescriber, dispenser, pharmacy, or patient
59 arising out of matters that are the subject of the report. A
60 department employee; and a person who participates in preparing,
61 reviewing, issuing, or any other activity related to an advisory
62 report is may not allowed be permitted or required to testify in
63 any such civil action as to any findings, recommendations,
64 evaluations, opinions, or other actions taken in connection with
65 preparing, reviewing, or issuing such a report.
66 (b) “Controlled substance” means a controlled substance
67 listed in Schedule II, Schedule III, or Schedule IV in s.
68 893.03.
69 (c) “Dispenser” means a pharmacy, dispensing pharmacist, or
70 dispensing health care practitioner, and includes a pharmacy,
71 dispensing pharmacist, or health care practitioner that is not
72 located in this state but is otherwise subject to the
73 jurisdiction of this state as to a particular dispensing
74 transaction.
75 (d) “Health care practitioner” or “practitioner” means a
76 any practitioner who is subject to licensure or regulation by
77 the department under chapter 458, chapter 459, chapter 461,
78 chapter 462, chapter 463, chapter 464, chapter 465, or chapter
79 466.
80 (e) “Health care regulatory board” means a any board for a
81 practitioner or health care practitioner who is licensed or
82 regulated by the department.
83 (f) “Pharmacy” means a any pharmacy that is subject to
84 licensure or regulation by the department under chapter 465 and
85 that dispenses or delivers a controlled substance to an
86 individual or address in this state.
87 (g) “Prescriber” means a prescribing physician, prescribing
88 practitioner, or other prescribing health care practitioner.
89 (h) “Active investigation” means an investigation that is
90 being conducted with a reasonable, good faith belief that it
91 will could lead to the filing of administrative, civil, or
92 criminal proceedings, or an investigation that is ongoing and
93 continuing and for which there is a reasonable, good faith
94 anticipation of securing an arrest or prosecution in the
95 foreseeable future.
96 (i) “Law enforcement agency” means the Department of Law
97 Enforcement, a Florida sheriff’s department, a Florida police
98 department, or a law enforcement agency of the Federal
99 Government which enforces the laws of this state or the United
100 States relating to controlled substances, and whose which its
101 agents and officers are empowered by law to conduct criminal
102 investigations and make arrests.
103 (j) “Program manager” means an employee of or a person
104 contracted by the Department of Health who is designated to
105 ensure the integrity of the prescription drug monitoring program
106 in accordance with the requirements established in paragraphs
107 (2)(a) and (b).
108 (k) “Dispense” or “dispensing” means the transfer of
109 possession of one or more doses of a medicinal drug by a health
110 care practitioner to the ultimate consumer or to the ultimate
111 consumer’s agent, including, but not limited to, a transaction
112 with a dispenser pursuant to chapter 465 and a dispensing
113 transaction to an individual or address in this state with a
114 dispenser that is located outside this state but is otherwise
115 subject to the jurisdiction of this state as to that dispensing
116 transaction.
117 (2)(a) The department shall maintain design and establish a
118 comprehensive electronic database system in order to collect and
119 store specified information from dispensed that has controlled
120 substance prescriptions and shall release information to
121 authorized recipients in accordance with subsection (6) and s.
122 893.0551 provided to it and that provides prescription
123 information to a patient’s health care practitioner and
124 pharmacist who inform the department that they wish the patient
125 advisory report provided to them. Otherwise, the patient
126 advisory report will not be sent to the practitioner, pharmacy,
127 or pharmacist. The system must shall be designed to provide
128 information regarding dispensed prescriptions of controlled
129 substances and shall not infringe upon the legitimate
130 prescribing or dispensing of a controlled substance by a
131 prescriber or dispenser acting in good faith and in the course
132 of professional practice and must. The system shall be
133 consistent with standards of the American Society for Automation
134 in Pharmacy (ASAP). The electronic system must shall also comply
135 with the Health Insurance Portability and Accountability Act
136 (HIPAA) as it pertains to protected health information (PHI),
137 electronic protected health information (EPHI), and all other
138 relevant state and federal privacy and security laws and
139 regulations. The department shall establish policies and
140 procedures as appropriate regarding the reporting, accessing the
141 database, evaluation, management, development, implementation,
142 operation, storage, and security of information within the
143 system. The reporting of prescribed controlled substances shall
144 include a dispensing transaction with a dispenser pursuant to
145 chapter 465 or through a dispensing transaction to an individual
146 or address in this state with a pharmacy that is not located in
147 this state but that is otherwise subject to the jurisdiction of
148 this state as to that dispensing transaction. The reporting of
149 patient advisory reports refers only to reports to patients,
150 pharmacies, and practitioners. Separate reports that contain
151 patient prescription history information and that are not
152 patient advisory reports are provided to persons and entities as
153 authorized in paragraphs (7)(b) and (c) and s. 893.0551.
154 (b) The department shall maintain the electronic system so
155 that a patient’s health care practitioner or pharmacist is able
156 to receive a patient advisory report upon request, when the
157 direct support organization receives at least $20,000 in
158 nonstate moneys or the state receives at least $20,000 in
159 federal grants for the prescription drug monitoring program,
160 shall adopt rules as necessary concerning the reporting,
161 accessing the database, evaluation, management, development,
162 implementation, operation, security, and storage of information
163 within the system, including rules for when patient advisory
164 reports are provided to pharmacies and prescribers. The patient
165 advisory report shall be provided in accordance with s.
166 893.13(7)(a)8. The department shall work with the professional
167 health care licensure boards, such as the Board of Medicine, the
168 Board of Osteopathic Medicine, and the Board of Pharmacy; other
169 appropriate organizations, such as the Florida Pharmacy
170 Association, the Florida Medical Association, the Florida Retail
171 Federation, and the Florida Osteopathic Medical Association,
172 including those relating to pain management; and the Attorney
173 General, the Department of Law Enforcement, and the Agency for
174 Health Care Administration to develop rules appropriate for the
175 prescription drug monitoring program.
176 (c) The department shall:
177 1. Establish policies and procedures and adopt rules
178 necessary to provide for access to and evaluation, management,
179 and operation of the electronic system.
180 2. Establish policies and procedures and adopt rules
181 necessary to provide for the reporting, storage, and security of
182 information within the electronic system, including:
183 a. Any additional information, other than the information
184 listed in subsection (3), which must be reported to the system.
185 b. The process by which dispensers must provide the
186 required information concerning each controlled substance that
187 it has dispensed in a secure methodology and format. Such
188 approved formats may include, but are not limited to, submission
189 via the Internet, on a disc, or by use of regular mail.
190 c. The process by which the department may approve an
191 extended period of time for a dispenser to report a dispensed
192 prescription to the system.
193 d. Procedures providing for reporting during a state
194 declared or nationally declared disaster.
195 e. Procedures for determining when a patient advisory
196 report is required to be provided to a pharmacy or prescriber.
197 f. Procedures for determining whether a request for
198 information under paragraph (6)(b) is authentic and authorized
199 by the requesting agency.
200 3. Cooperate with professional health care licensure
201 boards, such as the Board of Medicine, the Board of Osteopathic
202 Medicine, and the Board of Pharmacy; other appropriate
203 organizations, such as the Florida Pharmacy Association, the
204 Florida Medical Association, the Florida Retail Federation, the
205 Florida Osteopathic Medical Association, and those relating to
206 pain management; and the Attorney General, the Department of Law
207 Enforcement, and the Agency for Health Care Administration to
208 develop rules appropriate for the prescription drug monitoring
209 program All dispensers and prescribers subject to these
210 reporting requirements shall be notified by the department of
211 the implementation date for such reporting requirements.
212 4.(d) Cooperate The program manager shall work with
213 professional health care licensure boards and the stakeholders
214 listed in subparagraph 3. paragraph (b) to develop rules
215 appropriate for identifying indicators of controlled substance
216 abuse.
217 (3) The dispenser of The pharmacy dispensing the controlled
218 substance and each prescriber who directly dispenses a
219 controlled substance shall submit to the electronic system, by a
220 procedure and in a format established by the department and
221 consistent with an ASAP-approved format, the following
222 information for each prescription dispensed inclusion in the
223 database:
224 (a) The name of the prescribing practitioner, the
225 practitioner’s federal Drug Enforcement Administration
226 registration number, the practitioner’s National Provider
227 Identification (NPI) or other appropriate identifier, and the
228 date of the prescription.
229 (b) The date the prescription was filled and the method of
230 payment, such as cash by an individual, insurance coverage
231 through a third party, or Medicaid payment. This paragraph does
232 not authorize the department to include individual credit card
233 numbers or other account numbers in the database.
234 (c) The full name, address, and date of birth of the person
235 for whom the prescription was written.
236 (d) The name, national drug code, quantity, and strength of
237 the controlled substance dispensed.
238 (e) The full name, federal Drug Enforcement Administration
239 registration number, and address of the pharmacy or other
240 location from which the controlled substance was dispensed. If
241 the controlled substance was dispensed by a practitioner other
242 than a pharmacist, the practitioner’s full name, federal Drug
243 Enforcement Administration registration number, and address.
244 (f) The name of the pharmacy or practitioner, other than a
245 pharmacist, dispensing the controlled substance and the
246 practitioner’s National Provider Identification (NPI).
247 (g) Other appropriate identifying information as determined
248 by department rule.
249 (4) Each time a controlled substance is dispensed to an
250 individual, the information specified in subsection (3)
251 controlled substance shall be reported by the dispenser to the
252 department through the system using a department-approved
253 process as soon thereafter as possible, but not more than 7 days
254 after the date the controlled substance is dispensed unless an
255 extension is approved by the department. Costs to the dispenser
256 for submitting the information required by this section may not
257 be material or extraordinary. Costs not considered to be
258 material or extraordinary include, but are not limited to,
259 regular postage, electronic media, regular electronic mail, and
260 facsimile charges. A person who willfully and knowingly fails to
261 report the dispensing of a controlled substance as required by
262 this section commits a misdemeanor of the first degree,
263 punishable as provided in s. 775.082 or s. 775.083 for cause as
264 determined by rule. A dispenser must meet the reporting
265 requirements of this section by providing the required
266 information concerning each controlled substance that it
267 dispensed in a department-approved, secure methodology and
268 format. Such approved formats may include, but are not limited
269 to, submission via the Internet, on a disc, or by use of regular
270 mail.
271 (5) When the following acts of dispensing or administering
272 occur, The following acts are exempt from the reporting under
273 requirements of this section for that specific act of dispensing
274 or administration:
275 (a) The administration of A health care practitioner when
276 administering a controlled substance directly to a patient by a
277 health care practitioner if the amount of the controlled
278 substance is adequate to treat the patient during that
279 particular treatment session.
280 (b) The administration of A pharmacist or health care
281 practitioner when administering a controlled substance by a
282 health care practitioner to a patient or resident receiving care
283 as a patient at a hospital, nursing home, ambulatory surgical
284 center, hospice, or intermediate care facility for the
285 developmentally disabled which is licensed in this state.
286 (c) The administration or dispensing of A practitioner when
287 administering or dispensing a controlled substance by a health
288 care practitioner within in the health care system of the
289 Department of Corrections.
290 (d) The administration of A practitioner when administering
291 a controlled substance by a health care practitioner in the
292 emergency room of a licensed hospital.
293 (e) The administration or dispensing of A health care
294 practitioner when administering or dispensing a controlled
295 substance by a health care practitioner to a person under the
296 age of 16.
297 (f) The A pharmacist or a dispensing practitioner when
298 dispensing of a one-time, 72-hour emergency resupply of a
299 controlled substance by a dispenser to a patient.
300 (6) Confidential and exempt information in the prescription
301 drug monitoring program’s database may be released only as
302 provided in this subsection and s. 893.0551 The department may
303 establish when to suspend and when to resume reporting
304 information during a state-declared or nationally declared
305 disaster.
306 (7)(a) A practitioner or pharmacist who dispenses a
307 controlled substance must submit the information required by
308 this section in an electronic or other method in an ASAP format
309 approved by rule of the department unless otherwise provided in
310 this section. The cost to the dispenser in submitting the
311 information required by this section may not be material or
312 extraordinary. Costs not considered to be material or
313 extraordinary include, but are not limited to, regular postage,
314 electronic media, regular electronic mail, and facsimile
315 charges.
316 (a)(b) A pharmacy, prescriber, or dispenser shall have
317 access to information in the prescription drug monitoring
318 program’s database which relates to a patient of that pharmacy,
319 prescriber, or dispenser in a manner established by the
320 department as needed for the purpose of reviewing the patient’s
321 controlled substance prescription history. A prescriber or
322 dispenser acting in good faith is immune from any civil,
323 criminal, or administrative liability that might otherwise be
324 incurred or imposed for receiving or using information from the
325 prescription drug monitoring program. This subsection does not
326 create a private cause of action, and a person may not recover
327 damages against a prescriber or dispenser authorized to access
328 information under this subsection for accessing or failing to
329 access such information Other access to the program’s database
330 shall be limited to the program’s manager and to the designated
331 program and support staff, who may act only at the direction of
332 the program manager or, in the absence of the program manager,
333 as authorized. Access by the program manager or such designated
334 staff is for prescription drug program management only or for
335 management of the program’s database and its system in support
336 of the requirements of this section and in furtherance of the
337 prescription drug monitoring program. Confidential and exempt
338 information in the database shall be released only as provided
339 in paragraph (c) and s. 893.0551. The program manager,
340 designated program and support staff who act at the direction of
341 or in the absence of the program manager, and any individual who
342 has similar access regarding the management of the database from
343 the prescription drug monitoring program shall submit
344 fingerprints to the department for background screening. The
345 department shall follow the procedure established by the
346 Department of Law Enforcement to request a statewide criminal
347 history record check and to request that the Department of Law
348 Enforcement forward the fingerprints to the Federal Bureau of
349 Investigation for a national criminal history record check.
350 (b)(c) The following entities are shall not be allowed
351 direct access to information in the prescription drug monitoring
352 program database but may request from the program manager and,
353 when authorized by the program manager, the program manager’s
354 program and support staff, information that is confidential and
355 exempt under s. 893.0551. Before Prior to release, the request
356 by the following entities shall be verified as authentic and
357 authorized with the requesting organization by the program
358 manager or, the program manager’s program and support staff, or
359 as determined in rules by the department as being authentic and
360 as having been authorized by the requesting entity:
361 1. The department or its relevant health care regulatory
362 boards responsible for the licensure, regulation, or discipline
363 of practitioners, pharmacists, or other persons who are
364 authorized to prescribe, administer, or dispense controlled
365 substances and who are involved in a specific controlled
366 substance investigation involving a designated person for one or
367 more prescribed controlled substances.
368 2. The Attorney General for Medicaid fraud cases involving
369 prescribed controlled substances.
370 3. A law enforcement agency during active investigations of
371 regarding potential criminal activity, fraud, or theft regarding
372 prescribed controlled substances, in accordance with paragraph
373 (d).
374 4. A patient or the legal guardian or designated health
375 care surrogate of an incapacitated patient as described in s.
376 893.0551 who, for the purpose of verifying the accuracy of the
377 database information, submits a written and notarized request
378 that includes the patient’s full name, address, and date of
379 birth, and includes the same information if the legal guardian
380 or health care surrogate submits the request. If the patient’s
381 legal guardian or health care surrogate is the requestor, the
382 request shall be validated by the department to verify the
383 identity of the patient and the legal guardian or health care
384 surrogate, if the patient’s legal guardian or health care
385 surrogate is the requestor. Such verification is also required
386 for any request to change a patient’s prescription history or
387 other information related to his or her information in the
388 electronic database.
389 5. An impaired practitioner consultant who is retained by
390 the department under s. 456.076 shall have access to information
391 in the prescription drug monitoring program’s database, in a
392 manner established by the department, which relates to a
393 practitioner who has agreed to be evaluated or monitored by the
394 consultant, as needed for the purpose of reviewing the
395 practitioner’s controlled substance prescription history.
396 (c) Information in or released from the prescription drug
397 monitoring program database for the electronic prescription drug
398 monitoring system is not discoverable or admissible in any civil
399 or administrative action, except in an investigation and
400 disciplinary proceeding by the department or the appropriate
401 regulatory board. Information shared with a state attorney
402 pursuant to s. 893.0551(3)(a) or (c) may be released only in
403 response to a discovery demand if such information is directly
404 related to the criminal case for which the information was
405 requested. If additional information is shared with the state
406 attorney which is not directly related to the criminal case, the
407 state attorney shall inform the inquirer that such information
408 exists. Unrelated information may not be released except upon an
409 order of a court of competent jurisdiction.
410 (d) The department shall adopt a user agreement by rule.
411 Before releasing any information pursuant to subparagraph (b)3.,
412 the department shall enter into a user agreement with the law
413 enforcement agency requesting information from the prescription
414 drug monitoring database. At a minimum, the user agreement must:
415 1. Provide for access control and information security in
416 order to ensure the confidentiality of the information.
417 2. Contain training requirements.
418 3. Require each agency head to submit an annual attestation
419 to the program manager that the user agreement is being complied
420 with and to disclose any findings and actions taken to maintain
421 compliance. Any findings of noncompliance must be reported
422 immediately by the agency head to the program manager.
423 4. Require each agency that receives information from the
424 database to electronically update the database semiannually with
425 the status of the case for which the information was requested,
426 in accordance with procedures established by department rule.
427 5. Require each agency head to appoint one agency
428 administrator to be responsible for appointing authorized users
429 to request and receive investigative reports on behalf of the
430 agency to ensure the agency maintains compliance with the user
431 agreement and laws governing access, use, and dissemination of
432 information received.
433 6. Require each authorized user to attest that each request
434 for confidential information from the database is predicated on
435 and related to an active investigation.
436 7. Require the agency to conduct annual audits of the
437 administrator and of each authorized user to ensure the user
438 agreement is being followed. Such audits must be conducted by an
439 internal affairs, professional compliance, inspector general, or
440 similarly situated unit within the agency which normally handles
441 inspections or internal investigations for that agency. The
442 review must include any allegations of noncompliance, potential
443 security violations, and a report on the user’s compliance with
444 laws, rules, and the user agreement. The agency shall also
445 conduct routine audits on access and dissemination of records.
446 The results of each audit shall be submitted to the program
447 manager within 7 days after completing the audit. By October 1,
448 2014, the department shall adopt rules to ensure that each
449 agency is complying with the audit requirements pursuant to this
450 subparagraph.
451 8. Allow the program manager to restrict, suspend, or
452 terminate an administrator’s or authorized user’s access to
453 information in the database if the department finds that the
454 administrator or authorized user has failed to comply with the
455 terms of the user agreement. If an agency does not comply with
456 the department’s rules on audit requirements, the program
457 manager shall suspend the agency’s access to information in the
458 database until the agency comes into compliance with such rules.
459 (e)(d) Other than the program manager and his or her
460 program or support staff as authorized in paragraph (f),
461 department staff are, for the purpose of calculating performance
462 measures pursuant to subsection (8), shall not be allowed direct
463 access to information in the prescription drug monitoring
464 program database but may request from the program manager and,
465 when authorized by the program manager, the program manager’s
466 program and support staff, information that does not contain
467 contains no identifying information of any patient, physician,
468 health care practitioner, prescriber, or dispenser and that is
469 not confidential and exempt for the purpose of calculating
470 performance measures pursuant to subsection (7).
471 (f) The program manager and designated support staff, upon
472 the direction of the program manager or as otherwise authorized
473 during the program manager’s absence, may access the
474 prescription drug monitoring program database only to manage the
475 program or to manage the program database and systems in support
476 of the requirements of this section or as established by the
477 department in rule pursuant to subparagraph (2)(c)4. The program
478 manager, designated program and support staff who act at the
479 direction of or in the absence of the program manager, and any
480 individual who has similar access regarding the management of
481 the database from the prescription drug monitoring program shall
482 submit fingerprints to the department for background screening.
483 The department shall follow the procedure established by the
484 Department of Law Enforcement to request a statewide criminal
485 history record check and to request that the Department of Law
486 Enforcement forward the fingerprints to the Federal Bureau of
487 Investigation for a national criminal history record check.
488 (g) If the program manager determines a pattern consistent
489 with the rules established under subparagraph (2)(c)4., the
490 department may provide:
491 1. A patient advisory report to an appropriate health care
492 practitioner; and
493 2. Relevant information that does not contain personal
494 identifying information to the applicable law enforcement
495 agency. A law enforcement agency may use such information to
496 determine whether an active investigation is warranted.
497 (h)(e) All transmissions of data required by this section
498 must comply with relevant state and federal privacy and security
499 laws and regulations. However, an any authorized agency or
500 person under s. 893.0551 receiving such information as allowed
501 by s. 893.0551 may maintain the information received for up to
502 24 months before purging it from his or her records or maintain
503 it for longer than 24 months if the information is pertinent to
504 ongoing health care or an active law enforcement investigation
505 or prosecution.
506 (f) The program manager, upon determining a pattern
507 consistent with the rules established under paragraph (2)(d) and
508 having cause to believe a violation of s. 893.13(7)(a)8.,
509 (8)(a), or (8)(b) has occurred, may provide relevant information
510 to the applicable law enforcement agency.
511 (7)(8) To assist in fulfilling program responsibilities,
512 performance measures shall be reported annually to the Governor,
513 the President of the Senate, and the Speaker of the House of
514 Representatives by the department each December 1, beginning in
515 2011. Data that does not contain patient, physician, health care
516 practitioner, prescriber, or dispenser identifying information
517 may be requested during the year by department employees so that
518 the department may undertake public health care and safety
519 initiatives that take advantage of observed trends. Performance
520 measures may include, but are not limited to, efforts to achieve
521 the following outcomes:
522 (a) Reduction of the rate of inappropriate use of
523 prescription drugs through department education and safety
524 efforts.
525 (b) Reduction of the quantity of pharmaceutical controlled
526 substances obtained by individuals attempting to engage in fraud
527 and deceit.
528 (c) Increased coordination among partners participating in
529 the prescription drug monitoring program.
530 (d) Involvement of stakeholders in achieving improved
531 patient health care and safety and reduction of prescription
532 drug abuse and prescription drug diversion.
533 (9) Any person who willfully and knowingly fails to report
534 the dispensing of a controlled substance as required by this
535 section commits a misdemeanor of the first degree, punishable as
536 provided in s. 775.082 or s. 775.083.
537 (8)(10) Notwithstanding s. 456.025 and subject to the
538 General Appropriations Act, up to $500,000 of all costs incurred
539 by the department in administering the prescription drug
540 monitoring program may shall be funded through funds available
541 in the Medical Quality Assurance Trust Fund that are related to
542 the regulation of the practice of pharmacy under chapter 465.
543 The department also may apply for and receive federal grants or
544 private funding to fund the prescription drug monitoring program
545 except that the department may not receive funds provided,
546 directly or indirectly, by prescription drug manufacturers
547 applied for or received by the state. The department may not
548 commit state funds for the monitoring program if such funds are
549 necessary for the department’s regulation of the practice of
550 pharmacy under chapter 465 without ensuring funding is
551 available. The prescription drug monitoring program and the
552 implementation thereof are contingent upon receipt of the
553 nonstate funding. The department and state government shall
554 cooperate with the direct-support organization established
555 pursuant to subsection (11) in seeking federal grant funds,
556 other nonstate grant funds, gifts, donations, or other private
557 moneys for the department if the costs of doing so are not
558 considered material. Nonmaterial costs for this purpose include,
559 but are not limited to, the costs of mailing and personnel
560 assigned to research or apply for a grant. Notwithstanding the
561 exemptions to competitive-solicitation requirements under s.
562 287.057(3)(e), the department shall comply with the competitive
563 solicitation requirements under s. 287.057 for the procurement
564 of any goods or services required by this section. Funds
565 provided, directly or indirectly, by prescription drug
566 manufacturers may not be used to implement the program.
567 (11) The department may establish a direct-support
568 organization that has a board consisting of at least five
569 members to provide assistance, funding, and promotional support
570 for the activities authorized for the prescription drug
571 monitoring program.
572 (a) As used in this subsection, the term “direct-support
573 organization” means an organization that is:
574 1. A Florida corporation not for profit incorporated under
575 chapter 617, exempted from filing fees, and approved by the
576 Department of State.
577 2. Organized and operated to conduct programs and
578 activities; raise funds; request and receive grants, gifts, and
579 bequests of money; acquire, receive, hold, and invest, in its
580 own name, securities, funds, objects of value, or other
581 property, either real or personal; and make expenditures or
582 provide funding to or for the direct or indirect benefit of the
583 department in the furtherance of the prescription drug
584 monitoring program.
585 (b) The direct-support organization is not considered a
586 lobbying firm within the meaning of s. 11.045.
587 (c) The State Surgeon General shall appoint a board of
588 directors for the direct-support organization. Members of the
589 board shall serve at the pleasure of the State Surgeon General.
590 The State Surgeon General shall provide guidance to members of
591 the board to ensure that moneys received by the direct-support
592 organization are not received from inappropriate sources.
593 Inappropriate sources include, but are not limited to, donors,
594 grantors, persons, or organizations that may monetarily or
595 substantively benefit from the purchase of goods or services by
596 the department in furtherance of the prescription drug
597 monitoring program.
598 (d) The direct-support organization shall operate under
599 written contract with the department. The contract must, at a
600 minimum, provide for:
601 1. Approval of the articles of incorporation and bylaws of
602 the direct-support organization by the department.
603 2. Submission of an annual budget for the approval of the
604 department.
605 3. Certification by the department that the direct-support
606 organization is complying with the terms of the contract in a
607 manner consistent with and in furtherance of the goals and
608 purposes of the prescription drug monitoring program and in the
609 best interests of the state. Such certification must be made
610 annually and reported in the official minutes of a meeting of
611 the direct-support organization.
612 4. The reversion, without penalty, to the state of all
613 moneys and property held in trust by the direct-support
614 organization for the benefit of the prescription drug monitoring
615 program if the direct-support organization ceases to exist or if
616 the contract is terminated.
617 5. The fiscal year of the direct-support organization,
618 which must begin July 1 of each year and end June 30 of the
619 following year.
620 6. The disclosure of the material provisions of the
621 contract to donors of gifts, contributions, or bequests,
622 including such disclosure on all promotional and fundraising
623 publications, and an explanation to such donors of the
624 distinction between the department and the direct-support
625 organization.
626 7. The direct-support organization’s collecting, expending,
627 and providing of funds to the department for the development,
628 implementation, and operation of the prescription drug
629 monitoring program as described in this section and s. 2,
630 chapter 2009-198, Laws of Florida, as long as the task force is
631 authorized. The direct-support organization may collect and
632 expend funds to be used for the functions of the direct-support
633 organization’s board of directors, as necessary and approved by
634 the department. In addition, the direct-support organization may
635 collect and provide funding to the department in furtherance of
636 the prescription drug monitoring program by:
637 a. Establishing and administering the prescription drug
638 monitoring program’s electronic database, including hardware and
639 software.
640 b. Conducting studies on the efficiency and effectiveness
641 of the program to include feasibility studies as described in
642 subsection (13).
643 c. Providing funds for future enhancements of the program
644 within the intent of this section.
645 d. Providing user training of the prescription drug
646 monitoring program, including distribution of materials to
647 promote public awareness and education and conducting workshops
648 or other meetings, for health care practitioners, pharmacists,
649 and others as appropriate.
650 e. Providing funds for travel expenses.
651 f. Providing funds for administrative costs, including
652 personnel, audits, facilities, and equipment.
653 g. Fulfilling all other requirements necessary to implement
654 and operate the program as outlined in this section.
655 (e) The activities of the direct-support organization must
656 be consistent with the goals and mission of the department, as
657 determined by the department, and in the best interests of the
658 state. The direct-support organization must obtain a written
659 approval from the department for any activities in support of
660 the prescription drug monitoring program before undertaking
661 those activities.
662 (f) The department may permit, without charge, appropriate
663 use of administrative services, property, and facilities of the
664 department by the direct-support organization, subject to this
665 section. The use must be directly in keeping with the approved
666 purposes of the direct-support organization and may not be made
667 at times or places that would unreasonably interfere with
668 opportunities for the public to use such facilities for
669 established purposes. Any moneys received from rentals of
670 facilities and properties managed by the department may be held
671 in a separate depository account in the name of the direct
672 support organization and subject to the provisions of the letter
673 of agreement with the department. The letter of agreement must
674 provide that any funds held in the separate depository account
675 in the name of the direct-support organization must revert to
676 the department if the direct-support organization is no longer
677 approved by the department to operate in the best interests of
678 the state.
679 (g) The department may adopt rules under s. 120.54 to
680 govern the use of administrative services, property, or
681 facilities of the department or office by the direct-support
682 organization.
683 (h) The department may not permit the use of any
684 administrative services, property, or facilities of the state by
685 a direct-support organization if that organization does not
686 provide equal membership and employment opportunities to all
687 persons regardless of race, color, religion, gender, age, or
688 national origin.
689 (i) The direct-support organization shall provide for an
690 independent annual financial audit in accordance with s.
691 215.981. Copies of the audit shall be provided to the department
692 and the Office of Policy and Budget in the Executive Office of
693 the Governor.
694 (j) The direct-support organization may not exercise any
695 power under s. 617.0302(12) or (16).
696 (12) A prescriber or dispenser may have access to the
697 information under this section which relates to a patient of
698 that prescriber or dispenser as needed for the purpose of
699 reviewing the patient’s controlled drug prescription history. A
700 prescriber or dispenser acting in good faith is immune from any
701 civil, criminal, or administrative liability that might
702 otherwise be incurred or imposed for receiving or using
703 information from the prescription drug monitoring program. This
704 subsection does not create a private cause of action, and a
705 person may not recover damages against a prescriber or dispenser
706 authorized to access information under this subsection for
707 accessing or failing to access such information.
708 (9)(13) To the extent that funding is provided for such
709 purpose through federal or private grants or gifts and other
710 types of available moneys, the department shall study the
711 feasibility of enhancing the prescription drug monitoring
712 program for the purposes of public health initiatives and
713 statistical reporting that respects the privacy of the patient,
714 the prescriber, and the dispenser. Such a study shall be
715 conducted in order to further improve the quality of health care
716 services and safety by improving the prescribing and dispensing
717 practices for prescription drugs, taking advantage of advances
718 in technology, reducing duplicative prescriptions and the
719 overprescribing of prescription drugs, and reducing drug abuse.
720 The requirements of the National All Schedules Prescription
721 Electronic Reporting (NASPER) Act are authorized in order to
722 apply for federal NASPER funding. In addition, the direct
723 support organization shall provide funding for the department to
724 conduct training for health care practitioners and other
725 appropriate persons in using the monitoring program to support
726 the program enhancements.
727 (10)(14) A pharmacist, pharmacy, or dispensing health care
728 practitioner or his or her agent, Before releasing a controlled
729 substance to any person not known to him or her such dispenser,
730 the dispenser shall require the person purchasing, receiving, or
731 otherwise acquiring the controlled substance to present valid
732 photographic identification or other verification of his or her
733 identity to the dispenser. If the person does not have proper
734 identification, the dispenser may verify the validity of the
735 prescription and the identity of the patient with the prescriber
736 or his or her authorized agent. Verification of health plan
737 eligibility through a real-time inquiry or adjudication system
738 is will be considered to be proper identification. This
739 subsection does not apply in an institutional setting or to a
740 long-term care facility, including, but not limited to, an
741 assisted living facility or a hospital to which patients are
742 admitted. As used in this subsection, the term “proper
743 identification” means an identification that is issued by a
744 state or the Federal Government containing the person’s
745 photograph, printed name, and signature or a document considered
746 acceptable under 8 C.F.R. s. 274a.2(b)(1)(v)(A) and (B).
747 (15) The Agency for Health Care Administration shall
748 continue the promotion of electronic prescribing by health care
749 practitioners, health care facilities, and pharmacies under s.
750 408.0611.
751 (16) The department shall adopt rules pursuant to ss.
752 120.536(1) and 120.54 to administer the provisions of this
753 section, which shall include as necessary the reporting,
754 accessing, evaluation, management, development, implementation,
755 operation, and storage of information within the monitoring
756 program’s system.
757 Section 2. This act shall take effect July 1, 2014.
