H.B. 186 Enrolled

1

CONTROLLED SUBSTANCE DATABASE
2 REVISIONS
3 2010 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor: Ronda Rudd Menlove
6 Senate Sponsor: Curtis S. Bramble
7
8 LONG TITLE
9 General Description:
10 This bill amends access provisions relating to the controlled substance database.
11 Highlighted Provisions:
12 This bill:
13 . permits employees of the Department of Health to have access to information in the
14 controlled substance database in relation to a person whom the Department of
15 Health suspects may be improperly obtaining or providing a controlled substance;
16 and
17 . makes technical changes.
18 Monies Appropriated in this Bill:
19 None
20 Other Special Clauses:
21 This bill coordinates with H.B. 28, Controlled Substance Database Amendments, by
22 providing technical amendments.
23 Utah Code Sections Affected:
24 AMENDS:
25 58-37-7.5, as last amended by Laws of Utah 2009, Chapter 41
26 Utah Code Sections Affected by Coordination Clause:
27 58-37f-301, Utah Code Annotated 1953
28
29 Be it enacted by the Legislature of the state of Utah:

30 Section 1. Section 58-37-7.5 is amended to read:
31 58-37-7.5. Controlled substance database -- Pharmacy reporting requirements --
32 Access -- Penalties.
33 (1) As used in this section:
34 (a) "Board" means the Utah State Board of Pharmacy created in Section 58-17b-201 .
35 (b) "Database" means the controlled substance database created in this section.
36 (c) "Database manager" means the person responsible for operating the database, or
37 the person's designee.
38 (d) "Division" means the Division of Occupational and Professional Licensing created
39 in Section 58-1-103 .
40 (e) "Health care facility" is as defined in Section 26-21-2 .
41 (f) "Mental health therapist" is as defined in Section 58-60-102 .
42 (g) "Pharmacy" or "pharmaceutical facility" is as defined in Section 58-17b-102 .
43 (h) "Prospective patient" means a person who:
44 (i) is seeking medical advice, medical treatment, or medical services from a
45 practitioner; and
46 (ii) the practitioner described in Subsection (1)(h)(i) is considering accepting as a
47 patient.
48 (i) "Substance abuse treatment program" is as defined in Section 62A-2-101 .
49 (2) (a) There is created within the division a controlled substance database.
50 (b) The division shall administer and direct the functioning of the database in
51 accordance with this section. The division may under state procurement laws contract with
52 another state agency or private entity to establish, operate, or maintain the database. The
53 division in collaboration with the board shall determine whether to operate the database within
54 the division or contract with another entity to operate the database, based on an analysis of
55 costs and benefits.
56 (c) The purpose of the database is to contain data as described in this section
57 regarding every prescription for a controlled substance dispensed in the state to any person

58 other than an inpatient in a licensed health care facility.
59 (d) Data required by this section shall be submitted in compliance with this section to
60 the manager of the database by the pharmacist in charge of the drug outlet where the
61 controlled substance is dispensed.
62 (3) The board shall advise the division regarding:
63 (a) establishing, maintaining, and operating the database;
64 (b) access to the database and how access is obtained; and
65 (c) control of information contained in the database.
66 (4) The pharmacist in charge shall, regarding each controlled substance dispensed by a
67 pharmacist under the pharmacist's supervision other than those dispensed for an inpatient at a
68 health care facility, submit to the manager of the database the following information, by a
69 procedure and in a format established by the division:
70 (a) name of the prescribing practitioner;
71 (b) date of the prescription;
72 (c) date the prescription was filled;
73 (d) name of the person for whom the prescription was written;
74 (e) positive identification of the person receiving the prescription, including the type
75 of identification and any identifying numbers on the identification;
76 (f) name of the controlled substance;
77 (g) quantity of controlled substance prescribed;
78 (h) strength of controlled substance;
79 (i) quantity of controlled substance dispensed;
80 (j) dosage quantity and frequency as prescribed;
81 (k) name of drug outlet dispensing the controlled substance;
82 (l) name of pharmacist dispensing the controlled substance; and
83 (m) other relevant information as required by division rule.
84 (5) The division shall maintain the database in an electronic file or by other means
85 established by the division to facilitate use of the database for identification of:

86 (a) prescribing practices and patterns of prescribing and dispensing controlled
87 substances;
88 (b) practitioners prescribing controlled substances in an unprofessional or unlawful
89 manner;
90 (c) individuals receiving prescriptions for controlled substances from licensed
91 practitioners, and who subsequently obtain dispensed controlled substances from a drug outlet
92 in quantities or with a frequency inconsistent with generally recognized standards of dosage
93 for that controlled substance; and
94 (d) individuals presenting forged or otherwise false or altered prescriptions for
95 controlled substances to a pharmacy.
96 (6) (a) The division shall by rule establish the electronic format in which the
97 information required under this section shall be submitted to the administrator of the database.
98 (b) The division shall ensure the database system records and maintains for reference:
99 (i) identification of each person who requests or receives information from the
100 database;
101 (ii) the information provided to each person; and
102 (iii) the date and time the information is requested or provided.
103 (7) The division shall make rules to:
104 (a) effectively enforce the limitations on access to the database as described in
105 Subsection (8); and
106 (b) establish standards and procedures to ensure accurate identification of individuals
107 requesting information or receiving information without request from the database.
108 (8) The manager of the database shall make information in the database available only
109 to the following persons, in accordance with the requirements of this section and division
110 rules:
111 (a) personnel of the division specifically assigned to conduct investigations related to
112 controlled substances laws under the jurisdiction of the division;
113 (b) authorized division personnel engaged in analysis of controlled substance

114 prescription information as a part of the assigned duties and responsibilities of their
115 employment;
116 (c) in accordance with a written agreement entered into with the department,
117 employees of the Department of Health:
118 (i) whom the director of the Department of Health assigns to conduct scientific studies
119 regarding the use or abuse of controlled substances, provided that the identity of the
120 individuals and pharmacies in the database are confidential and are not disclosed in any
121 manner to any individual who is not directly involved in the scientific studies; or
122 (ii) when the information is requested by the Department of Health in relation to a
123 person whom the Department of Health suspects may be improperly obtaining or providing a
124 controlled substance;
125 (d) a licensed practitioner having authority to prescribe controlled substances, to the
126 extent the information:
127 (i) (A) relates specifically to a current or prospective patient of the practitioner; and
128 (B) is sought by the practitioner for the purpose of:
129 (I) prescribing or considering prescribing any controlled substance to the current or
130 prospective patient;
131 (II) diagnosing the current or prospective patient;
132 (III) providing medical treatment or medical advice to the current or prospective
133 patient; or
134 (IV) determining whether the current or prospective patient:
135 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner;
136 or
137 (Bb) has fraudulently obtained, or attempted to fraudulently obtain, a controlled
138 substance from the practitioner;
139 (ii) (A) relates specifically to a former patient of the practitioner; and
140 (B) is sought by the practitioner for the purpose of determining whether the former
141 patient has fraudulently obtained, or has attempted to fraudulently obtain, a controlled

142 substance from the practitioner;
143 (iii) relates specifically to an individual who has access to the practitioner's Drug
144 Enforcement Administration number, and the practitioner suspects that the individual may
145 have used the practitioner's Drug Enforcement Administration identification number to
146 fraudulently acquire or prescribe a controlled substance;
147 (iv) relates to the practitioner's own prescribing practices, except when specifically
148 prohibited by the division by administrative rule;
149 (v) relates to the use of the controlled substance database by an employee of the
150 practitioner, described in Subsection (8)(e); or
151 (vi) relates to any use of the practitioner's Drug Enforcement Administration
152 identification number to obtain, attempt to obtain, prescribe, or attempt to prescribe, a
153 controlled substance;
154 (e) in accordance with Subsection (17), an employee of a practitioner described in
155 Subsection (8)(d), for a purpose described in Subsection (8)(d)(i) or (ii), if:
156 (i) the employee is designated by the practitioner as a person authorized to access the
157 information on behalf of the practitioner;
158 (ii) the practitioner provides written notice to the division of the identity of the
159 employee; and
160 (iii) the division:
161 (A) grants the employee access to the database; and
162 (B) provides the employee with a password that is unique to that employee to access
163 the database in order to permit the division to comply with the requirements of Subsection
164 (6)(b) with respect to the employee;
165 (f) a licensed pharmacist having authority to dispense controlled substances to the
166 extent the information is sought for the purpose of:
167 (i) dispensing or considering dispensing any controlled substance; or
168 (ii) determining whether a person:
169 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist; or

170 (B) has fraudulently obtained, or attempted to fraudulently obtain, a controlled
171 substance from the pharmacist;
172 (g) federal, state, and local law enforcement authorities, and state and local
173 prosecutors, engaged as a specified duty of their employment in enforcing laws:
174 (i) regulating controlled substances; or
175 (ii) investigating insurance fraud, Medicaid fraud, or Medicare fraud;
176 (h) a mental health therapist, if:
177 (i) the information relates to a patient who is:
178 (A) enrolled in a licensed substance abuse treatment program; and
179 (B) receiving treatment from, or under the direction of, the mental health therapist as
180 part of the patient's participation in the licensed substance abuse treatment program described
181 in Subsection (8)(h)(i)(A);
182 (ii) the information is sought for the purpose of determining whether the patient is
183 using a controlled substance while the patient is enrolled in the licensed substance abuse
184 treatment program described in Subsection (8)(h)(i)(A); and
185 (iii) the licensed substance abuse treatment program described in Subsection
186 (8)(h)(i)(A) is associated with a practitioner who:
187 (A) is a physician, a physician assistant, an advance practice registered nurse, or a
188 pharmacist; and
189 (B) is available to consult with the mental health therapist regarding the information
190 obtained by the mental health therapist, under this Subsection (8)(h), from the database; and
191 (i) an individual who is the recipient of a controlled substance prescription entered
192 into the database, upon providing evidence satisfactory to the database manager that the
193 individual requesting the information is in fact the person about whom the data entry was
194 made.
195 (9) Any person who knowingly and intentionally releases any information in the
196 database in violation of the limitations under Subsection (8) is guilty of a third degree felony.
197 (10) (a) Any person who obtains or attempts to obtain information from the database

198 by misrepresentation or fraud is guilty of a third degree felony.
199 (b) Any person who obtains or attempts to obtain information from the database for a
200 purpose other than a purpose authorized by this section or by rule is guilty of a third degree
201 felony.
202 (11) (a) Except as provided in Subsection (11)(d), a person may not knowingly and
203 intentionally use, release, publish, or otherwise make available to any other person or entity
204 any information obtained from the database for any purpose other than those specified in
205 Subsection (8). Each separate violation of this Subsection (11) is a third degree felony and is
206 also subject to a civil penalty not to exceed $5,000.
207 (b) The procedure for determining a civil violation of this Subsection (11) shall be in
208 accordance with Section 58-1-108 , regarding adjudicative proceedings within the division.
209 (c) Civil penalties assessed under this Subsection (11) shall be deposited in the
210 General Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
211 (d) Nothing in this Subsection (11) prohibits a person who obtains information from
212 the database under Subsection (8)(d) or (e) from:
213 (i) including the information in the person's medical chart or file for access by a
214 person authorized to review the medical chart or file; or
215 (ii) providing the information to a person in accordance with the requirements of the
216 Health Insurance Portability and Accountability Act of 1996.
217 (12) (a) The failure of a pharmacist in charge to submit information to the database as
218 required under this section after the division has submitted a specific written request for the
219 information or when the division determines the individual has a demonstrable pattern of
220 failing to submit the information as required is grounds for the division to take the following
221 actions in accordance with Section 58-1-401 :
222 (i) refuse to issue a license to the individual;
223 (ii) refuse to renew the individual's license;
224 (iii) revoke, suspend, restrict, or place on probation the license;
225 (iv) issue a public or private reprimand to the individual;

226 (v) issue a cease and desist order; and
227 (vi) impose a civil penalty of not more than $1,000 for each dispensed prescription
228 regarding which the required information is not submitted.
229 (b) Civil penalties assessed under Subsection (12)(a)(vi) shall be deposited in the
230 General Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
231 (c) The procedure for determining a civil violation of this Subsection (12) shall be in
232 accordance with Section 58-1-108 , regarding adjudicative proceedings within the division.
233 (13) An individual who has submitted information to the database in accordance with
234 this section may not be held civilly liable for having submitted the information.
235 (14) All department and the division costs necessary to establish and operate the
236 database shall be funded by appropriations from:
237 (a) the Commerce Service Fund; and
238 (b) the General Fund.
239 (15) All costs associated with recording and submitting data as required in this section
240 shall be assumed by the submitting pharmacy.
241 (16) (a) Except as provided in Subsection (16)(b), data provided to, maintained in, or
242 accessed from the database that may be identified to, or with, a particular person is not subject
243 to discovery, subpoena, or similar compulsory process in any civil, judicial, administrative, or
244 legislative proceeding, nor shall any individual or organization with lawful access to the data
245 be compelled to testify with regard to the data.
246 (b) The restrictions in Subsection (16)(a) do not apply to:
247 (i) a criminal proceeding; or
248 (ii) a civil, judicial, or administrative action brought to enforce the provisions of this
249 section, Section 58-37-7.7 , or Section 58-37-7.8 .
250 (17) (a) A practitioner described in Subsection (8)(d) may designate up to three
251 employees to access information from the database under Subsection (8)(e).
252 (b) The division shall make rules, in accordance with Title 63G, Chapter 3, Utah
253 Administrative Rulemaking Act, to establish background check procedures to determine

254 whether an employee designated under Subsection (8)(e)(i) should be granted access to the
255 database.
256 (c) The division shall grant an employee designated under Subsection (8)(e)(i) access
257 to the database, unless the division determines, based on a background check, that the
258 employee poses a security risk to the information contained in the database.
259 (d) The division may impose a fee, in accordance with Section 63J-1-504 , on a
260 practitioner who designates an employee under Subsection (8)(e)(i), to pay for the costs
261 incurred by the division to conduct the background check and make the determination
262 described in Subsection (17)(c).
263 (18) (a) A person who is granted access to the database based on the fact that the
264 person is a licensed practitioner or a mental health therapist shall be denied access to the
265 database when the person is no longer licensed.
266 (b) A person who is granted access to the database based on the fact that the person is
267 a designated employee of a licensed practitioner shall be denied access to the database when
268 the practitioner is no longer licensed.
269 (19) A person who is a relative of a deceased individual is not entitled to access
270 information from the database relating to the deceased individual based on the fact or claim
271 that the person is:
272 (a) related to the deceased individual; or
273 (b) subrogated to the rights of the deceased individual.
274 Section 2. Coordinating H.B. 186 with H.B. 28 -- Technical amendments.
275 If this H.B. 186 and H.B. 28, Controlled Substance Database Amendments, both pass,
276 it is the intent of the Legislature that the Office of Legislative Research and General Counsel
277 shall prepare the Utah Code database for publication by modifying Subsection
278 58-37f-301 (2)(c) in H.B. 28 to read as follows:
279 "(c) in accordance with a written agreement entered into with the department,
280 employees of the Department of Health:
281 (i) whom the director of the Department of Health assigns to conduct scientific studies

282 regarding the use or abuse of controlled substances, provided that the identity of the
283 individuals and pharmacies in the database are confidential and are not disclosed in any
284 manner to any individual who is not directly involved in the scientific studies; or
285 (ii) when the information is requested by the Department of Health in relation to a
286 person whom the Department of Health suspects may be improperly obtaining or providing a
287 controlled substance;".