HB 143

1	A bill to be entitled
2	An act relating to monitoring the dispensing of controlled
3	substances; creating s. 893.055, F.S.; providing
4	definitions; requiring the Department of Health to
5	establish a comprehensive electronic system to monitor the
6	dispensing of certain controlled substances and to collect
7	biometric identifiers of recipients; requiring health care
8	practitioners and pharmacies who dispense certain
9	controlled substances to have an active and operational
10	biometric scanning device connected to a database and to
11	submit specified information to the database before
12	dispensing such substances; requiring the database to
13	assign a unique identifier to each prescription and to
14	provide specified information concerning any conflicting
15	or overlapping prescriptions to the prescribing
16	practitioner; providing exceptions to reporting
17	requirements; requiring that data be submitted in an
18	approved electronic format; providing for data retention;
19	requiring that data transmissions comply with privacy and
20	security laws; providing for rulemaking concerning data to
21	be reported and for reporting formats; providing criminal
22	penalties for violations; specifying an effective date for
23	criminal penalties; providing an effective date.
24
25	Be It Enacted by the Legislature of the State of Florida:
26
27	Section 1.  Section 893.055, Florida Statutes, is created
28	to read:
29	893.055  Electronic system for monitoring the dispensing of
30	certain controlled substances.--
31	(1)  As used in this section and s. 893.0551, the term:
32	(a)  "Biometric identifier" means an established unique
33	form of biological identification readily compared and matched,
34	such as a fingerprint, retinal scan, or other means of similar
35	biometric identification approved by the department and
36	authorized for retention in a database.
37	(b)  "Biometric scan" means an electronic scan of a
38	biometric identifier.
39	(c)  "Biometric scanning device" means an electronic
40	scanning device approved by the department that is designed to
41	accurately capture a biometric identifier.
42	(d)  "Database" means an electronic database, or network of
43	databases, that is maintained by or contracted for by the
44	department and that maintains and compares each biometric scan
45	and the information contained therewith in conformity with the
46	provisions of this section.
47	(e)  "Health care practitioner" or "practitioner" means any
48	practitioner subject to licensure or regulation by the
49	department under chapter 458, chapter 459, chapter 461, or
50	chapter 466.
51	(f)  "Pharmacy" means a pharmacy subject to licensure or
52	regulation by the department under chapter 465.
53	(2)  By March 1, 2011, the department shall adopt an
54	electronic monitoring system to monitor the collection of
55	biometric identifiers and to record and store, in a secure
56	database, the following:
57	(a)  The dispensing of controlled substances listed in
58	Schedule II, Schedule III, and Schedule IV by health care
59	practitioners within the state.
60	(b)  The dispensing or delivering of controlled substances
61	listed in Schedule II, Schedule III, and Schedule IV to
62	individuals in this state by any pharmacy licensed in this state
63	and by any health care practitioner registered with the
64	department as a dispensing practitioner.
65	(3)  Any health care practitioner who dispenses or delivers
66	a controlled substance listed in Schedule II, Schedule III, or
67	Schedule IV must have in the practitioner's office an active and
68	operational biometric scanning device connected to the database.
69	Any such practitioner who dispenses or delivers such a
70	controlled substance to a person in this state must first obtain
71	a biometric scan of an approved biometric identifier of the
72	person through use of the biometric scanning device and submit
73	the same to the database.
74	(4)  Any pharmacy that dispenses or delivers a prescription
75	for a controlled substance listed in Schedule II, Schedule III,
76	or Schedule IV must have in the pharmacy an active and
77	operational biometric scanning device connected to the database.
78	Any pharmacy that dispenses or delivers a prescription for such
79	a controlled substance to a person in this state must first
80	obtain a biometric scan of an approved biometric identifier of
81	the person through use of the biometric scanning device and
82	submit the same to the database.
83	(5)  Prior to dispensing or delivering a controlled
84	substance listed in Schedule II, Schedule III, or Schedule IV to
85	a person in this state, every health care practitioner and
86	prescribing pharmacy must submit the following information to
87	the database:
88	(a)  The biometric scan of the person's biometric
89	identifier.
90	(b)  The full name and address of the prescribing
91	practitioner.
92	(c)  The date of each prescription.
93	(d)  The name of the controlled substance prescribed and
94	the strength, quantity, and directions for use thereof.
95	(6)  After receiving the information required under
96	subsection (5), the database shall assign the prescription a
97	unique identifying number and shall immediately transmit the
98	following to the prescribing practitioner:
99	(a)  The unique identifying number.
100	(b)  The names of controlled substances listed in Schedule
101	II, Schedule III, and Schedule IV that have been prescribed in
102	connection with the biometric scan submitted that may conflict
103	with or overlap the prescribing practitioner's prescription.
104	(c)  The full name and address of the practitioner whose
105	prescription may conflict with or overlap the prescribing
106	practitioner's prescription and the full name and address of the
107	practitioner or pharmacy that dispensed or delivered the
108	conflicting or overlapping prescription.
109	(7)  Prior to dispensing or delivering a prescription for a
110	controlled substance listed in Schedule II, Schedule III, or
111	Schedule IV, the pharmacist or dispensing health care
112	practitioner shall submit the biometric scan of the person's
113	biometric identifier to the database and the database shall
114	immediately transmit the following to the pharmacy or dispensing
115	health care practitioner:
116	(a)  The names of controlled substances listed in Schedule
117	II, Schedule III, and Schedule IV that have been prescribed in
118	connection with the biometric scan submitted that may conflict
119	with or overlap the prescription to be dispensed or delivered.
120	(b)  The full name and address of the practitioner whose
121	prescription may conflict with or overlap the prescription to be
122	dispensed or delivered and the full name and address of the
123	practitioner or pharmacy that dispensed or delivered the
124	conflicting or overlapping prescription.
125	(8)  The database shall not retain personal protected
126	health care information other than the biometric scans and the
127	prescription information provided to the database pursuant to
128	subsections (6) and (7). This section shall not preclude health
129	care practitioners and pharmacies from retaining personal
130	information on their patients that is collected and maintained
131	in their regular course of business in compliance with
132	applicable law.
133	(9)  This section does not apply to controlled substances
134	listed in Schedule II, Schedule III, or Schedule IV:
135	(a)  Administered by a health care practitioner directly to
136	his or her patient;
137	(b)  Dispensed or delivered by a health care practitioner
138	authorized to prescribe controlled substances directly to a
139	patient and limited to an amount adequate to treat the patient
140	for a period of no more than 72 hours;
141	(c)  Dispensed or delivered by a health care practitioner
142	or a pharmacist to an inpatient of a facility that holds an
143	institutional pharmacy permit;
144	(d)  Ordered from an institutional pharmacy licensed under
145	s. 465.019 in accordance with internal policy and procedure for
146	controlled substances listed in Schedule II, Schedule III, and
147	Schedule IV;
148	(e)  Dispensed or delivered by a pharmacist or administered
149	by a health care practitioner to a patient or resident receiving
150	care from a hospital, nursing home, assisted living facility,
151	home health care agency, hospice, or intermediate care facility
152	for the developmentally disabled that is licensed in this state;
153	(f)  Prescribed by a health care practitioner for a patient
154	younger than 16 years of age;
155	(g)  Prescribed or dispensed pursuant to rule adopted by
156	the department; or
157	(h)  Administered, prescribed, dispensed, or delivered
158	under circumstances in which the pharmacist or practitioner
159	cannot, in good faith, comply with the provisions of this
160	section.
161	(10)  A dispensing practitioner or pharmacist who dispenses
162	or delivers a controlled substance listed in Schedule II,
163	Schedule III, or Schedule IV shall submit the information
164	required under this section to the department, or any person or
165	agency authorized by the department, in an electronic format
166	approved by the department. The department, or the person or
167	agency authorized by the department, shall maintain the
168	information for no longer than 24 months from the date of
169	receipt and shall thereafter expunge the information unless
170	otherwise directed by a court of competent jurisdiction.
171	(11)  All transmissions required by this section must
172	comply with relevant federal and state privacy and security
173	laws.
174	(12)  By March 1, 2010, the department, together with the
175	Board of Pharmacy and the Board of Medicine, shall adopt rules
176	pursuant to ss. 120.536(1) and 120.54 governing the
177	administration of this section, including rules governing access
178	to the database by practitioners and pharmacists and
179	implementing procedures to be employed when a biometric scanning
180	device is inoperable or the database is inaccessible.
181	(13)  Any person who knowingly fails to comply with any
182	provision of this section commits a misdemeanor of the first
183	degree, punishable as provided in s. 775.082 or s. 775.083.
184	Section 2.  The penalties in s. 893.055(13), Florida
185	Statutes, as created by this act, shall take effect March 1,
186	2011, or upon the adoption of the rules pursuant to s.
187	893.055(12), Florida Statutes, as created by this act, whichever
188	occurs first, and shall apply to acts or omissions on or after
189	that date.
190	Section 3.  This act shall take effect July 1, 2009.

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