Florida Senate - 2010 SB 1722
By Senator Fasano
11-00747B-10 20101722__
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, in conjunction 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; providing an effective date.
40
41 Be It Enacted by the Legislature of the State of Florida:
42
43 Section 1. Subsections (2), (3), (5), and (7) of section
44 893.055, Florida Statutes, are amended to read:
45 893.055 Prescription drug monitoring program.—
46 (2)(a) By December 1, 2010, the department shall design and
47 establish a comprehensive electronic database system that has
48 controlled substance prescriptions provided to it and that
49 provides prescription information to a patient’s health care
50 practitioner and pharmacist who inform the department that they
51 wish the patient advisory report provided to them. Otherwise,
52 the patient advisory report will not be sent to the
53 practitioner, pharmacy, or pharmacist. The system shall be
54 designed to provide information regarding dispensed
55 prescriptions of controlled substances and shall not infringe
56 upon the legitimate prescribing or dispensing of a controlled
57 substance by a prescriber or dispenser acting in good faith and
58 in the course of professional practice. The system shall be
59 consistent with standards of the American Society for Automation
60 in Pharmacy (ASAP). The electronic system shall also comply with
61 the Health Insurance Portability and Accountability Act (HIPAA)
62 as it pertains to protected health information (PHI), electronic
63 protected health information (EPHI), the National All Schedules
64 Prescription Electronic Reporting (NASPER) Act’s minimum
65 requirements for authentication of a practitioner that requests
66 information in the prescription drug monitoring program database
67 and certification of the purpose for which information is
68 requested, and all other relevant state and federal privacy and
69 security laws and regulations. The department shall establish
70 policies and procedures as appropriate regarding the reporting,
71 accessing the database, evaluation, management, development,
72 implementation, operation, storage, and security of information
73 within the system. The reporting of prescribed controlled
74 substances shall include a dispensing transaction with a
75 dispenser pursuant to chapter 465 or through a dispensing
76 transaction to an individual or address in this state with a
77 pharmacy that is not located in this state but that is otherwise
78 subject to the jurisdiction of this state as to that dispensing
79 transaction. The reporting of patient advisory reports refers
80 only to reports to patients, pharmacies, and practitioners.
81 Separate reports that contain patient prescription history
82 information and that are not patient advisory reports are
83 provided to persons and entities as authorized in paragraphs
84 (7)(b) and (c) and s. 893.0551.
85 (b)1. The department’s prescription drug monitoring program
86 shall:
87 a. Provide reports directly to the Department of Law
88 Enforcement without review by the department or a regulatory
89 board so that the Department of Law Enforcement may investigate
90 whether any violation of law has occurred regarding controlled
91 substances in Schedule II, Schedule III, or Schedule IV; and
92 b. Report, if applicable, the information to the
93 appropriate state attorney or other law enforcement agency in
94 accordance with state law.
95
96 The parameters for such reports shall be adopted by rule of the
97 department and developed in conjunction with the Department of
98 Law Enforcement, the Florida Medical Association, the Florida
99 Osteopathic Medicine Association, and the Florida Pain Society.
100 2. The department, when the direct support organization
101 receives at least $20,000 in nonstate moneys or the state
102 receives at least $20,000 in federal grants for the prescription
103 drug monitoring program, and in consultation with the Office of
104 Drug Control, shall adopt rules as necessary concerning the
105 reporting, accessing the database, evaluation, management,
106 development, implementation, operation, security, and storage of
107 information within the system, including rules for when patient
108 advisory reports are provided to pharmacies and prescribers. The
109 patient advisory report shall be provided in accordance with s.
110 893.13(7)(a)8. The department shall work with the professional
111 health care licensure boards, such as the Board of Medicine, the
112 Board of Osteopathic Medicine, and the Board of Pharmacy; other
113 appropriate organizations, such as the Florida Pharmacy
114 Association, the Office of Drug Control, the Florida Medical
115 Association, the Florida Retail Federation, and the Florida
116 Osteopathic Medical Association, including those relating to
117 pain management; and the Attorney General, the Department of Law
118 Enforcement, and the Agency for Health Care Administration to
119 develop rules appropriate for the prescription drug monitoring
120 program.
121 (c) All dispensers and prescribers subject to these
122 reporting requirements shall be notified by the department of
123 the implementation date for such reporting requirements.
124 (d) The department shall establish a method to allow
125 corrections to the database when notified by a health care
126 practitioner or pharmacist.
127 (3) The pharmacy dispensing the controlled substance and
128 each prescriber who directly dispenses a controlled substance
129 shall submit to the electronic system, by a procedure and in a
130 format established by the department and consistent with an
131 ASAP-approved format, the following information for inclusion in
132 the database:
133 (a) The name of the prescribing practitioner, the
134 practitioner’s federal Drug Enforcement Administration
135 registration number, the practitioner’s National Provider
136 Identification (NPI) or other appropriate identifier, and the
137 date of the prescription.
138 (b) The date the prescription was filled and the method of
139 payment, such as cash by an individual, insurance coverage
140 through a third party, or Medicaid payment. This paragraph does
141 not authorize the department to include individual credit card
142 numbers or other account numbers in the database.
143 (c) The full name, address, and date of birth of the person
144 for whom the prescription was written.
145 (d) The name, national drug code, quantity, and strength of
146 the controlled substance dispensed.
147 (e) The full name, federal Drug Enforcement Administration
148 registration number, and address of the pharmacy or other
149 location from which the controlled substance was dispensed. If
150 the controlled substance was dispensed by a practitioner other
151 than a pharmacist, the practitioner’s full name, federal Drug
152 Enforcement Administration registration number, and address.
153 (f) The name of the pharmacy or practitioner, other than a
154 pharmacist, dispensing the controlled substance and the
155 practitioner’s National Provider Identification (NPI).
156 (g) Other appropriate identifying information as determined
157 by department rule.
158 (h) The number of refills ordered and whether the drug was
159 dispensed as a refill of a prescription or was a first-time
160 request.
161 (5) When the following acts of dispensing or administering
162 occur, the following are exempt from reporting under this
163 section for that specific act of dispensing or administration:
164 (a) A health care practitioner when administering a
165 controlled substance directly to a patient if the amount of the
166 controlled substance is adequate to treat the patient during
167 that particular treatment session.
168 (b) A pharmacist or health care practitioner when
169 administering a controlled substance to a patient or resident
170 receiving care as a patient at a hospital, nursing home,
171 ambulatory surgical center, hospice, or intermediate care
172 facility for the developmentally disabled which is licensed in
173 this state.
174 (c) A practitioner when administering or dispensing a
175 controlled substance in the health care system of the Department
176 of Corrections.
177 (c)(d) A practitioner when administering a controlled
178 substance in the emergency room of a licensed hospital.
179 (d)(e) A health care practitioner when administering or
180 dispensing a controlled substance directly to a patient person
181 under the age of 16 if the amount of the controlled substance is
182 adequate to treat the patient during that particular treatment
183 session.
184 (e)(f) A pharmacist or a dispensing practitioner when
185 dispensing a one-time, 48-hour 72-hour emergency resupply of a
186 controlled substance to a patient.
187 (7)(a) A practitioner or pharmacist who dispenses a
188 controlled substance must submit the information required by
189 this section in an electronic or other method in an ASAP format
190 approved by rule of the department unless otherwise provided in
191 this section. The cost to the dispenser in submitting the
192 information required by this section may not be material or
193 extraordinary. Costs not considered to be material or
194 extraordinary include, but are not limited to, regular postage,
195 electronic media, regular electronic mail, and facsimile
196 charges.
197 (b)1. In order for a pharmacy, prescriber, practitioner, or
198 dispenser to shall have access to information in the
199 prescription drug monitoring program’s database which relates to
200 a patient of that pharmacy, prescriber, practitioner, or
201 dispenser, the pharmacy, prescriber, practitioner, or dispenser
202 shall register with the department by submitting a registration
203 document provided by the department in a manner established by
204 the department as needed for the purpose of reviewing the
205 patient’s controlled substance prescription history. The
206 registration document must be notarized before it is submitted
207 to the department. Before a pharmacy, prescriber, practitioner,
208 or dispenser is granted access to information in the
209 prescription drug monitoring program’s database, the submitted
210 document must be approved by the department. Upon approval, the
211 department shall grant the registrant access to the appropriate
212 information in the prescription drug monitoring program’s
213 database.
214 2. Other access to the program’s database shall be limited
215 to the program program’s manager and to the designated program
216 and support staff, who may act only at the direction of the
217 program manager or, in the absence of the program manager, as
218 authorized. Access by the program manager or such designated
219 staff is for prescription drug program management only or for
220 management of the program’s database and its system in support
221 of the requirements of this section and in furtherance of the
222 prescription drug monitoring program. Confidential and exempt
223 information in the database shall be released only as provided
224 in paragraph (c) and s. 893.0551. The program manager,
225 designated program and support staff who act at the direction of
226 or in the absence of the program manager, and any individual who
227 has similar access regarding the management of the prescription
228 drug monitoring program database must submit fingerprints to the
229 department for background screening. The department shall follow
230 the procedure established by the Department of Law Enforcement
231 to request a statewide criminal history record check and to
232 request that the Department of Law Enforcement forward the
233 fingerprints to the Federal Bureau of Investigation for a
234 national criminal history record check.
235 (c) The following entities shall not be allowed direct
236 access to information in the prescription drug monitoring
237 program database but may request from the program manager and,
238 when authorized by the program manager, the program manager’s
239 program and support staff, information that is confidential and
240 exempt under s. 893.0551. Prior to release, the request shall be
241 verified as authentic and authorized with the requesting
242 organization by the program manager, the program manager’s
243 program and support staff, or as determined in rules by the
244 department as being authentic and as having been authorized by
245 the requesting entity:
246 1. The department or its relevant health care regulatory
247 boards responsible for the licensure, regulation, or discipline
248 of practitioners, pharmacists, or other persons who are
249 authorized to prescribe, administer, or dispense controlled
250 substances and who are involved in a specific controlled
251 substance investigation involving a designated person for one or
252 more prescribed controlled substances.
253 2. The Attorney General or the Agency for Health Care
254 Administration for Medicaid fraud cases or Medicaid
255 investigations involving prescribed controlled substances.
256 3. A law enforcement agency during active investigations
257 regarding potential criminal activity, fraud, or theft regarding
258 prescribed controlled substances.
259 4. A patient or the legal guardian or designated health
260 care surrogate of an incapacitated patient as described in s.
261 893.0551 who, for the purpose of verifying the accuracy of the
262 database information, submits a written and notarized request
263 that includes the patient’s full name, address, and date of
264 birth, and includes the same information if the legal guardian
265 or health care surrogate submits the request. The patient’s
266 phone number and a copy of a government-issued photo
267 identification must be provided in person to the program manager
268 along with the notarized request. The request shall be validated
269 by the department to verify the identity of the patient and the
270 legal guardian or health care surrogate, if the patient’s legal
271 guardian or health care surrogate is the requestor. Such
272 verification is also required for any request to change a
273 patient’s prescription history or other information related to
274 his or her information in the electronic database.
275
276 Information in the database for the electronic prescription drug
277 monitoring system is not discoverable or admissible in any civil
278 or administrative action, except in an investigation and
279 disciplinary proceeding by the department or the appropriate
280 regulatory board.
281 (d) The following entities shall not be allowed direct
282 access to information in the prescription drug monitoring
283 program database but may request from the program manager and,
284 when authorized by the program manager, the program manager’s
285 program and support staff, information that contains no
286 identifying information of any patient, physician, health care
287 practitioner, prescriber, or dispenser and that is not
288 confidential and exempt:
289 1. Department staff for the purpose of calculating
290 performance measures pursuant to subsection (8).
291 2. The Program Implementation and Oversight Task Force for
292 its reporting to the Governor, the President of the Senate, and
293 the Speaker of the House of Representatives regarding the
294 prescription drug monitoring program. This subparagraph expires
295 July 1, 2012.
296 (e) All transmissions of data required by this section must
297 comply with relevant state and federal privacy and security laws
298 and regulations. However, any authorized agency or person under
299 s. 893.0551 receiving such information as allowed by s. 893.0551
300 may maintain the information received for up to 24 months before
301 purging it from his or her records or maintain it for longer
302 than 24 months if the information is pertinent to ongoing health
303 care or an active law enforcement investigation or prosecution.
304 Section 2. This act shall take effect July 1, 2010.