Florida Senate - 2010 CS for SB 1722
By the Committee on Health Regulation; and Senators Fasano and
1 A bill to be entitled
2 An act relating to the prescription drug monitoring
3 program; amending s. 893.055, F.S.; requiring that the
4 comprehensive electronic database system containing
5 information concerning prescriptions of controlled
6 substances comply with the minimum requirements for
7 authentication and certification of the National All
8 Schedules Prescription Electronic Reporting Act;
9 requiring the Department of Health to provide reports
10 from the prescription drug monitoring program to the
11 Department of Law Enforcement; requiring the
12 Department of Health, after consultation with the
13 Department of Law Enforcement and other associations,
14 to adopt rules; requiring the Department of Health to
15 establish a method to allow corrections to the program
16 database; revising the information to be submitted to
17 the program database by a pharmacy or prescriber;
18 revising the acts of dispensing or administering
19 controlled substances which are exempt from reporting;
20 requiring a pharmacy, prescriber, practitioner, or
21 dispenser to register with the Department of Health in
22 order to obtain certain information from the
23 prescription drug monitoring program; requiring the
24 program manager and certain other individuals who have
25 access to the prescription drug monitoring program
26 database to submit fingerprints to the Department of
27 Health; requiring the Department of Health to follow
28 the proper procedures established by the Department of
29 Law Enforcement to request state and national criminal
30 history record checks; prohibiting the Agency for
31 Health Care Administration from having direct access
32 to information in the prescription drug monitoring
33 program database for purposes of Medicaid fraud cases
34 or investigations; requiring a patient, legal
35 guardian, or designated health care surrogate to
36 provide the patient’s phone number and a copy of a
37 government-issued photo identification in order to
38 verify information in the prescription drug monitoring
39 program database; authorizing the State Surgeon
40 General to enter into agreements with other states to
41 exchange prescription drug monitoring information
42 after specified conditions are met; providing factors
43 for considering such agreements; limiting the purposes
44 for which information may be shared under such
45 agreements; amending s. 893.0551, F.S.; authorizing
46 the disclosure of information in the prescription drug
47 monitoring program under certain conditions; providing
48 an effective date.
50 Be It Enacted by the Legislature of the State of Florida:
52 Section 1. Subsections (2), (3), (5), and (7) of section
53 893.055, Florida Statutes, are amended, and subsection (8) is
54 added to that section, to read:
55 893.055 Prescription drug monitoring program.—
56 (2)(a) By December 1, 2010, the department shall design and
57 establish a comprehensive electronic database system that has
58 controlled substance prescriptions provided to it and that
59 provides prescription information to a patient’s health care
60 practitioner and pharmacist who inform the department that they
61 wish the patient advisory report provided to them. Otherwise,
62 the patient advisory report will not be sent to the
63 practitioner, pharmacy, or pharmacist. The system shall be
64 designed to provide information regarding dispensed
65 prescriptions of controlled substances and shall not infringe
66 upon the legitimate prescribing or dispensing of a controlled
67 substance by a prescriber or dispenser acting in good faith and
68 in the course of professional practice. The system shall be
69 consistent with standards of the American Society for Automation
70 in Pharmacy (ASAP). The electronic system shall also comply with
71 the Health Insurance Portability and Accountability Act (HIPAA)
72 as it pertains to protected health information (PHI), electronic
73 protected health information (EPHI), the National All Schedules
74 Prescription Electronic Reporting (NASPER) Act’s minimum
75 requirements for authentication of a practitioner that requests
76 information in the prescription drug monitoring program database
77 and certification of the purpose for which information is
78 requested, and all other relevant state and federal privacy and
79 security laws and regulations. The department shall establish
80 policies and procedures as appropriate regarding the reporting,
81 accessing the database, evaluation, management, development,
82 implementation, operation, storage, and security of information
83 within the system. The reporting of prescribed controlled
84 substances shall include a dispensing transaction with a
85 dispenser pursuant to chapter 465 or through a dispensing
86 transaction to an individual or address in this state with a
87 pharmacy that is not located in this state but that is otherwise
88 subject to the jurisdiction of this state as to that dispensing
89 transaction. The reporting of patient advisory reports refers
90 only to reports to patients, pharmacies, and practitioners.
91 Separate reports that contain patient prescription history
92 information and that are not patient advisory reports are
93 provided to persons and entities as authorized in paragraphs
94 (7)(b) and (c) and s. 893.0551.
95 (b)1. The department’s prescription drug monitoring program
97 a. Provide reports directly to the Department of Law
98 Enforcement without review by the department or a regulatory
99 board so that the Department of Law Enforcement may investigate
100 whether any violation of law has occurred regarding controlled
101 substances in Schedule II, Schedule III, or Schedule IV; and
102 b. Report, if applicable, the information to the
103 appropriate state attorney or other law enforcement agency in
104 accordance with state law.
106 The parameters for such reports shall be adopted by rule of the
107 department and developed after consultation with the Department
108 of Law Enforcement, the Florida Medical Association, and the
109 Florida Osteopathic Medical Association.
110 2. The department, when the direct support organization
111 receives at least $20,000 in nonstate moneys or the state
112 receives at least $20,000 in federal grants for the prescription
113 drug monitoring program, and in consultation with the Office of
114 Drug Control, shall adopt rules as necessary concerning the
115 reporting, accessing the database, evaluation, management,
116 development, implementation, operation, security, and storage of
117 information within the system, including rules for when patient
118 advisory reports are provided to pharmacies and prescribers. The
119 patient advisory report shall be provided in accordance with s.
120 893.13(7)(a)8. The department shall work with the professional
121 health care licensure boards, such as the Board of Medicine, the
122 Board of Osteopathic Medicine, and the Board of Pharmacy; other
123 appropriate organizations, such as the Florida Pharmacy
124 Association, the Office of Drug Control, the Florida Medical
125 Association, the Florida Retail Federation, and the Florida
126 Osteopathic Medical Association, including those relating to
127 pain management; and the Attorney General, the Department of Law
128 Enforcement, and the Agency for Health Care Administration to
129 develop rules appropriate for the prescription drug monitoring
131 (c) All dispensers and prescribers subject to these
132 reporting requirements shall be notified by the department of
133 the implementation date for such reporting requirements.
134 (d) The department shall establish a method to allow
135 corrections to the database when notified by a health care
136 practitioner or pharmacist.
137 (3) The pharmacy dispensing the controlled substance and
138 each prescriber who directly dispenses a controlled substance
139 shall submit to the electronic system, by a procedure and in a
140 format established by the department and consistent with an
141 ASAP-approved format, the following information for inclusion in
142 the database:
143 (a) The name of the prescribing practitioner, the
144 practitioner’s federal Drug Enforcement Administration
145 registration number, the practitioner’s National Provider
146 Identification (NPI) or other appropriate identifier, and the
147 date of the prescription.
148 (b) The date the prescription was filled and the method of
149 payment, such as cash by an individual, insurance coverage
150 through a third party, or Medicaid payment. This paragraph does
151 not authorize the department to include individual credit card
152 numbers or other account numbers in the database.
153 (c) The full name, address, and date of birth of the person
154 for whom the prescription was written.
155 (d) The name, national drug code, quantity, and strength of
156 the controlled substance dispensed.
157 (e) The full name, federal Drug Enforcement Administration
158 registration number, and address of the pharmacy or other
159 location from which the controlled substance was dispensed. If
160 the controlled substance was dispensed by a practitioner other
161 than a pharmacist, the practitioner’s full name, federal Drug
162 Enforcement Administration registration number, and address.
163 (f) The name of the pharmacy or practitioner, other than a
164 pharmacist, dispensing the controlled substance and the
165 practitioner’s National Provider Identification (NPI).
166 (g) Other appropriate identifying information as determined
167 by department rule.
168 (h) The number of refills ordered and whether the drug was
169 dispensed as a refill of a prescription or was a first-time
171 (5) When the following acts of dispensing or administering
172 occur, the following are exempt from reporting under this
173 section for that specific act of dispensing or administration:
174 (a) A health care practitioner when administering a
175 controlled substance directly to a patient if the amount of the
176 controlled substance is adequate to treat the patient during
177 that particular treatment session.
178 (b) A pharmacist or health care practitioner when
179 administering a controlled substance to a patient or resident
180 receiving care as a patient at a hospital, nursing home,
181 ambulatory surgical center, hospice, or intermediate care
182 facility for the developmentally disabled which is licensed in
183 this state.
(c) A practitioner when administering or dispensing a
185 controlled substance in the health care system of the Department
186 of Corrections.
187 (c) (d) A practitioner when administering a controlled
188 substance in the emergency room of a licensed hospital.
189 (d) (e) A health care practitioner when administering or
190 dispensing a controlled substance directly to a patient person
191 under the age of 16 if the amount of the controlled substance is
192 adequate to treat the patient during that particular treatment
194 (e) (f) A pharmacist or a dispensing practitioner when
195 dispensing a one-time, 48-hour 72-hour emergency resupply of a
196 controlled substance to a patient.
197 (7)(a) A practitioner or pharmacist who dispenses a
198 controlled substance must submit the information required by
199 this section in an electronic or other method in an ASAP format
200 approved by rule of the department unless otherwise provided in
201 this section. The cost to the dispenser in submitting the
202 information required by this section may not be material or
203 extraordinary. Costs not considered to be material or
204 extraordinary include, but are not limited to, regular postage,
205 electronic media, regular electronic mail, and facsimile
207 (b)1. In order for a pharmacy, prescriber, practitioner, or
208 dispenser to shall have access to information in the
209 prescription drug monitoring program’s database which relates to
210 a patient of that pharmacy, prescriber, practitioner, or
211 dispenser, the pharmacy, prescriber, practitioner, or dispenser
212 shall register with the department by submitting a registration
213 document provided by the department in a manner established by
214 the department as needed for the purpose of reviewing the
215 patient’s controlled substance prescription history. The
216 registration document must be notarized before it is submitted
217 to the department. Before a pharmacy, prescriber, practitioner,
218 or dispenser is granted access to information in the
219 prescription drug monitoring program’s database, the submitted
220 document must be approved by the department. Upon approval, the
221 department shall grant the registrant access to the appropriate
222 information in the prescription drug monitoring program’s
224 2. Other access to the program’s database shall be limited
225 to the program program’s manager and to the designated program
226 and support staff, who may act only at the direction of the
227 program manager or, in the absence of the program manager, as
228 authorized. Access by the program manager or such designated
229 staff is for prescription drug program management only or for
230 management of the program’s database and its system in support
231 of the requirements of this section and in furtherance of the
232 prescription drug monitoring program. Confidential and exempt
233 information in the database shall be released only as provided
234 in paragraph (c) and s. 893.0551. The program manager,
235 designated program and support staff who act at the direction of
236 or in the absence of the program manager, and any individual who
237 has similar access regarding the management of the prescription
238 drug monitoring program database must submit fingerprints to the
239 department for background screening. The department shall follow
240 the procedure established by the Department of Law Enforcement
241 to request a statewide criminal history record check and to
242 request that the Department of Law Enforcement forward the
243 fingerprints to the Federal Bureau of Investigation for a
244 national criminal history record check.
245 (c) Except as provided in subparagraph (2)(b)1., the
246 following entities shall not be allowed direct access to
247 information in the prescription drug monitoring program database
248 but may request from the program manager and, when authorized by
249 the program manager, the program manager’s program and support
250 staff, information that is confidential and exempt under s.
251 893.0551. Prior to release, the request shall be verified as
252 authentic and authorized with the requesting organization by the
253 program manager, the program manager’s program and support
254 staff, or as determined in rules by the department as being
255 authentic and as having been authorized by the requesting
257 1. The department or its relevant health care regulatory
258 boards responsible for the licensure, regulation, or discipline
259 of practitioners, pharmacists, or other persons who are
260 authorized to prescribe, administer, or dispense controlled
261 substances and who are involved in a specific controlled
262 substance investigation involving a designated person for one or
263 more prescribed controlled substances.
264 2. The Attorney General or the Agency for Health Care
265 Administration for Medicaid fraud cases or Medicaid
266 investigations involving prescribed controlled substances.
267 3. A law enforcement agency during active investigations
268 regarding potential criminal activity, fraud, or theft regarding
269 prescribed controlled substances.
270 4. A patient or the legal guardian or designated health
271 care surrogate of an incapacitated patient as described in s.
272 893.0551 who, for the purpose of verifying the accuracy of the
273 database information, submits a written and notarized request
274 that includes the patient’s full name, address, and date of
275 birth, and includes the same information if the legal guardian
276 or health care surrogate submits the request. The patient’s
277 phone number and a copy of a government-issued photo
278 identification must be provided in person to the program manager
279 along with the notarized request. The request shall be validated
280 by the department to verify the identity of the patient and the
281 legal guardian or health care surrogate, if the patient’s legal
282 guardian or health care surrogate is the requestor. Such
283 verification is also required for any request to change a
284 patient’s prescription history or other information related to
285 his or her information in the electronic database.
287 Information in the database for the electronic prescription drug
288 monitoring system is not discoverable or admissible in any civil
289 or administrative action, except in an investigation and
290 disciplinary proceeding by the department or the appropriate
291 regulatory board.
292 (d) The following entities shall not be allowed direct
293 access to information in the prescription drug monitoring
294 program database but may request from the program manager and,
295 when authorized by the program manager, the program manager’s
296 program and support staff, information that contains no
297 identifying information of any patient, physician, health care
298 practitioner, prescriber, or dispenser and that is not
299 confidential and exempt:
300 1. Department staff for the purpose of calculating
301 performance measures pursuant to subsection (8).
302 2. The Program Implementation and Oversight Task Force for
303 its reporting to the Governor, the President of the Senate, and
304 the Speaker of the House of Representatives regarding the
305 prescription drug monitoring program. This subparagraph expires
306 July 1, 2012.
307 (e) All transmissions of data required by this section must
308 comply with relevant state and federal privacy and security laws
309 and regulations. However, any authorized agency or person under
310 s. 893.0551 receiving such information as allowed by s. 893.0551
311 may maintain the information received for up to 24 months before
312 purging it from his or her records or maintain it for longer
313 than 24 months if the information is pertinent to ongoing health
314 care or an active law enforcement investigation or prosecution.
315 (8) After the prescription drug monitoring system has been
316 operational for 18 months, the State Surgeon General shall enter
317 into reciprocal agreements for the sharing of prescription drug
318 monitoring information with any other state or states that have
319 compatible prescription drug monitoring programs. If the State
320 Surgeon General evaluates the prescription drug monitoring
321 program of another state as authorized in this subsection,
322 priority shall be given to a state that is contiguous with the
323 borders of this state.
324 (a) In determining compatibility, the State Surgeon General
325 shall consider:
326 1. The essential purposes of the program and the success of
327 the program in fulfilling those purposes.
328 2. The safeguards for privacy of patient records and the
329 success of the program in protecting patient privacy.
330 3. The persons authorized to view the data collected by the
332 4. The schedules of the controlled substances monitored.
333 5. The data required to be submitted on each prescription.
334 6. Any implementation criteria deemed essential for a
335 thorough comparison.
336 (b) The State Surgeon General shall review any agreement on
337 an annual basis to determine its continued compatibility with
338 the prescription drug monitoring program in this state.
339 (c) Any agreement between the State Surgeon General and
340 another state shall prohibit the sharing of information about a
341 resident of this state or a practitioner, pharmacist, or other
342 prescriber for any purposes not otherwise authorized by this
343 section or s. 893.0551.
344 Section 2. Present subsections (4), (5), and (6) of section
345 893.0551, Florida Statutes, are renumbered as subsections (5),
346 (6), and (7), respectively, and a new subsection (4) is added to
347 that section, to read:
348 893.0551 Public records exemption for the prescription drug
349 monitoring program.—
350 (4) The department may disclose confidential and exempt
351 information contained in records held by the department under s.
352 893.055 if the State Surgeon General has entered into a
353 reciprocal agreement for the sharing of prescription drug
354 monitoring information with any other state that has compatible
355 prescription drug monitoring programs, as provided under s.
357 Section 3. This act shall take effect July 1, 2010.