Representative Brad M. Daw proposes the following substitute bill:


1     
CONTROLLED SUBSTANCE DATABASE REVISIONS

2     
2018 GENERAL SESSION

3     
STATE OF UTAH

4     
Chief Sponsor: Brad M. Daw

5     
Senate Sponsor: Curtis S. Bramble

6     

7     LONG TITLE
8     General Description:
9          This bill modifies provisions related to the controlled substance database administered
10     by the Division of Occupational and Professional Licensing (DOPL).
11     Highlighted Provisions:
12          This bill:
13          ▸     modifies the requirements related to providing information to DOPL for inclusion in
14     the controlled substance database;
15          ▸     modifies who may be penalized for failing to submit information to the controlled
16     substance database as required by state statute; and
17          ▸     makes technical changes.
18     Money Appropriated in this Bill:
19          None
20     Other Special Clauses:
21          None
22     Utah Code Sections Affected:
23     AMENDS:
24          58-37f-203, as last amended by Laws of Utah 2015, Chapters 89 and 326
25          58-37f-301, as last amended by Laws of Utah 2017, Chapter 237

26          58-37f-602, as enacted by Laws of Utah 2010, Chapter 287
27     

28     Be it enacted by the Legislature of the state of Utah:
29          Section 1. Section 58-37f-203 is amended to read:
30          58-37f-203. Submission, collection, and maintenance of data.
31          (1) (a) The division shall implement on a statewide basis, including non-resident
32     pharmacies as defined in Section 58-17b-102, the following two options for a pharmacist to
33     submit information:
34          (i) real-time submission of the information required to be submitted under this part to
35     the controlled substance database; and
36          (ii) 24-hour daily or next business day, whichever is later, batch submission of the
37     information required to be submitted under this part to the controlled substance database.
38          (b) (i) On and after January 1, 2016, a pharmacist shall comply with either:
39          (A) the submission time requirements established by the division under Subsection
40     (1)(a)(i); or
41          (B) the submission time requirements established by the division under Subsection
42     (1)(a)(ii).
43          (ii) Prior to January 1, 2016, a pharmacist may submit information using either option
44     under this Subsection (1).
45          (c) The division shall comply with Title 63G, Chapter 6a, Utah Procurement Code.
46          (2) (a) The [pharmacist in charge] pharmacist-in-charge and the pharmacist of the drug
47     outlet where a controlled substance is dispensed shall submit the data described in this section
48     to the division in accordance with:
49          (i) [in accordance with] the requirements of this section;
50          (ii) [in accordance with] the procedures established by the division; [and]
51          (iii) additional types of information or data fields established by the division; and
52          [(iii) in] (iv) the format established by the division.
53          (b) A dispensing medical practitioner licensed under Chapter 17b, Part 8, Dispensing
54     Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, shall comply with
55     the provisions of this section and the dispensing medical practitioner shall assume the duties of
56     the pharmacist under this chapter.

57          (3) The [pharmacist] pharmacist-in-charge and the pharmacist described in Subsection
58     (2) shall, for each controlled substance dispensed by a pharmacist under the pharmacist's
59     supervision other than those dispensed for an inpatient at a health care facility, submit to the
60     division [the following information:] any type of information or data field established by the
61     division by rule in accordance with Subsection (6).
62          [(a) the name of the prescribing practitioner;]
63          [(b) the date of the prescription;]
64          [(c) the date the prescription was filled;]
65          [(d) the name of the individual for whom the prescription was written;]
66          [(e) positive identification of the individual receiving the prescription, including the
67     type of identification and any identifying numbers on the identification;]
68          [(f) the name of the controlled substance;]
69          [(g) the quantity of the controlled substance prescribed;]
70          [(h) the strength of the controlled substance;]
71          [(i) the quantity of the controlled substance dispensed;]
72          [(j) the dosage quantity and frequency as prescribed;]
73          [(k) the name of the drug outlet dispensing the controlled substance; and]
74          [(l) the name of the pharmacist dispensing the controlled substance.]
75          (4) An individual whose records are in the database may obtain those records upon
76     submission of a written request to the division.
77          (5) (a) A patient whose record is in the database may contact the division in writing to
78     request correction of any of the patient's database information that is incorrect. The patient
79     shall provide a postal address for the division's response.
80          (b) The division shall grant or deny the request within 30 days from receipt of the
81     request and shall advise the requesting patient of its decision by mail postmarked within 35
82     days of receipt of the request.
83          (c) If the division denies a request under this Subsection (5) or does not respond within
84     35 days, the patient may submit an appeal to the Department of Commerce, within 60 days
85     after the postmark date of the patient's letter making a request for a correction under this
86     Subsection (5).
87          (6) The division shall make rules, in accordance with Title 63G, Chapter 3, Utah

88     Administrative Rulemaking Act, to establish submission requirements under this part[,
89     including the electronic format in which the information required under this section shall be
90     submitted to the division.], including:
91          (a) electronic format;
92          (b) submission procedures; and
93          (c) required information and data fields.
94          (7) The division shall ensure that the database system records and maintains for
95     reference:
96          (a) the identification of each individual who requests or receives information from the
97     database;
98          (b) the information provided to each individual; and
99          (c) the date and time that the information is requested or provided.
100          Section 2. Section 58-37f-301 is amended to read:
101          58-37f-301. Access to database.
102          (1) The division shall make rules, in accordance with Title 63G, Chapter 3, Utah
103     Administrative Rulemaking Act, to:
104          (a) effectively enforce the limitations on access to the database as described in this
105     part; 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          (2) The division shall make information in the database and information obtained from
109     other state or federal prescription monitoring programs by means of the database available only
110     to the following individuals, in accordance with the requirements of this chapter and division
111     rules:
112          (a) (i) personnel of the division specifically assigned to conduct investigations related
113     to controlled substance laws under the jurisdiction of the division; and
114          (ii) the following law enforcement officers, but the division may only provide
115     nonidentifying information, limited to gender, year of birth, and postal ZIP code, regarding
116     individuals for whom a controlled substance has been prescribed or to whom a controlled
117     substance has been dispensed:
118          (A) a law enforcement agency officer who is engaged in a joint investigation with the

119     division; and
120          (B) a law enforcement agency officer to whom the division has referred a suspected
121     criminal violation of controlled substance laws;
122          (b) authorized division personnel engaged in analysis of controlled substance
123     prescription information as a part of the assigned duties and responsibilities of their
124     employment;
125          (c) a board member if:
126          (i) the board member is assigned to monitor a licensee on probation; and
127          (ii) the board member is limited to obtaining information from the database regarding
128     the specific licensee on probation;
129          (d) a member of a diversion committee established in accordance with Subsection
130     58-1-404(2) if:
131          (i) the diversion committee member is limited to obtaining information from the
132     database regarding the person whose conduct is the subject of the committee's consideration;
133     and
134          (ii) the conduct that is the subject of the committee's consideration includes a violation
135     or a potential violation of Chapter 37, Utah Controlled Substances Act, or another relevant
136     violation or potential violation under this title;
137          (e) in accordance with a written agreement entered into with the department,
138     employees of the Department of Health:
139          (i) whom the director of the Department of Health assigns to conduct scientific studies
140     regarding the use or abuse of controlled substances, if the identity of the individuals and
141     pharmacies in the database are confidential and are not disclosed in any manner to any
142     individual who is not directly involved in the scientific studies;
143          (ii) when the information is requested by the Department of Health in relation to a
144     person or provider whom the Department of Health suspects may be improperly obtaining or
145     providing a controlled substance; or
146          (iii) in the medical examiner's office;
147          (f) in accordance with a written agreement entered into with the department, a designee
148     of the director of the Department of Health, who is not an employee of the Department of
149     Health, whom the director of the Department of Health assigns to conduct scientific studies

150     regarding the use or abuse of controlled substances pursuant to an application process
151     established in rule by the Department of Health, if:
152          (i) the designee provides explicit information to the Department of Health regarding
153     the purpose of the scientific studies;
154          (ii) the scientific studies to be conducted by the designee:
155          (A) fit within the responsibilities of the Department of Health for health and welfare;
156          (B) are reviewed and approved by an Institutional Review Board that is approved for
157     human subject research by the United States Department of Health and Human Services; and
158          (C) are not conducted for profit or commercial gain; and
159          (D) are conducted in a research facility, as defined by division rule, that is associated
160     with a university or college accredited by one or more regional or national accrediting agencies
161     recognized by the United States Department of Education;
162          (iii) the designee protects the information as a business associate of the Department of
163     Health; and
164          (iv) the identity of the prescribers, patients, and pharmacies in the database are
165     de-identified, confidential, not disclosed in any manner to the designee or to any individual
166     who is not directly involved in the scientific studies;
167          (g) in accordance with the written agreement entered into with the department and the
168     Department of Health, authorized employees of a managed care organization, as defined in 42
169     C.F.R. Sec. 438, if:
170          (i) the managed care organization contracts with the Department of Health under the
171     provisions of Section 26-18-405 and the contract includes provisions that:
172          (A) require a managed care organization employee who will have access to information
173     from the database to submit to a criminal background check; and
174          (B) limit the authorized employee of the managed care organization to requesting either
175     the division or the Department of Health to conduct a search of the database regarding a
176     specific Medicaid enrollee and to report the results of the search to the authorized employee;
177     and
178          (ii) the information is requested by an authorized employee of the managed care
179     organization in relation to a person who is enrolled in the Medicaid program with the managed
180     care organization, and the managed care organization suspects the person may be improperly

181     obtaining or providing a controlled substance;
182          (h) a licensed practitioner having authority to prescribe controlled substances, to the
183     extent the information:
184          (i) (A) relates specifically to a current or prospective patient of the practitioner; and
185          (B) is provided to or sought by the practitioner for the purpose of:
186          (I) prescribing or considering prescribing any controlled substance to the current or
187     prospective patient;
188          (II) diagnosing the current or prospective patient;
189          (III) providing medical treatment or medical advice to the current or prospective
190     patient; or
191          (IV) determining whether the current or prospective patient:
192          (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner;
193     or
194          (Bb) has fraudulently obtained, or attempted to fraudulently obtain, a controlled
195     substance from the practitioner;
196          (ii) (A) relates specifically to a former patient of the practitioner; and
197          (B) is provided to or sought by the practitioner for the purpose of determining whether
198     the former patient has fraudulently obtained, or has attempted to fraudulently obtain, a
199     controlled substance from the practitioner;
200          (iii) relates specifically to an individual who has access to the practitioner's Drug
201     Enforcement Administration identification number, and the practitioner suspects that the
202     individual may have used the practitioner's Drug Enforcement Administration identification
203     number to fraudulently acquire or prescribe a controlled substance;
204          (iv) relates to the practitioner's own prescribing practices, except when specifically
205     prohibited by the division by administrative rule;
206          (v) relates to the use of the controlled substance database by an employee of the
207     practitioner, described in Subsection (2)(i); or
208          (vi) relates to any use of the practitioner's Drug Enforcement Administration
209     identification number to obtain, attempt to obtain, prescribe, or attempt to prescribe, a
210     controlled substance;
211          (i) in accordance with Subsection (3)(a), an employee of a practitioner described in

212     Subsection (2)(h), for a purpose described in Subsection (2)(h)(i) or (ii), if:
213          (i) the employee is designated by the practitioner as an individual authorized to access
214     the information on behalf of the practitioner;
215          (ii) the practitioner provides written notice to the division of the identity of the
216     employee; and
217          (iii) the division:
218          (A) grants the employee access to the database; and
219          (B) provides the employee with a password that is unique to that employee to access
220     the database in order to permit the division to comply with the requirements of Subsection
221     58-37f-203(5) with respect to the employee;
222          (j) an employee of the same business that employs a licensed practitioner under
223     Subsection (2)(h) if:
224          (i) the employee is designated by the practitioner as an individual authorized to access
225     the information on behalf of the practitioner;
226          (ii) the practitioner and the employing business provide written notice to the division of
227     the identity of the designated employee; and
228          (iii) the division:
229          (A) grants the employee access to the database; and
230          (B) provides the employee with a password that is unique to that employee to access
231     the database in order to permit the division to comply with the requirements of Subsection
232     58-37f-203(5) with respect to the employee;
233          (k) a licensed pharmacist having authority to dispense a controlled substance to the
234     extent the information is provided or sought for the purpose of:
235          (i) dispensing or considering dispensing any controlled substance; or
236          (ii) determining whether a person:
237          (A) is attempting to fraudulently obtain a controlled substance from the pharmacist; or
238          (B) has fraudulently obtained, or attempted to fraudulently obtain, a controlled
239     substance from the pharmacist;
240          (l) in accordance with Subsection (3)(a), a licensed pharmacy technician and pharmacy
241     intern who is an employee of a pharmacy as defined in Section 58-17b-102, for the purposes
242     described in Subsection (2)(j)(i) or (ii), if:

243          (i) the employee is designated by the pharmacist-in-charge as an individual authorized
244     to access the information on behalf of a licensed pharmacist employed by the pharmacy;
245          (ii) the pharmacist-in-charge provides written notice to the division of the identity of
246     the employee; and
247          (iii) the division:
248          (A) grants the employee access to the database; and
249          (B) provides the employee with a password that is unique to that employee to access
250     the database in order to permit the division to comply with the requirements of Subsection
251     58-37f-203(5) with respect to the employee;
252          (m) pursuant to a valid search warrant, federal, state, and local law enforcement
253     officers and state and local prosecutors who are engaged in an investigation related to:
254          (i) one or more controlled substances; and
255          (ii) a specific person who is a subject of the investigation;
256          (n) subject to Subsection (7), a probation or parole officer, employed by the
257     Department of Corrections or by a political subdivision, to gain access to database information
258     necessary for the officer's supervision of a specific probationer or parolee who is under the
259     officer's direct supervision;
260          (o) employees of the Office of Internal Audit and Program Integrity within the
261     Department of Health who are engaged in their specified duty of ensuring Medicaid program
262     integrity under Section 26-18-2.3;
263          (p) a mental health therapist, if:
264          (i) the information relates to a patient who is:
265          (A) enrolled in a licensed substance abuse treatment program; and
266          (B) receiving treatment from, or under the direction of, the mental health therapist as
267     part of the patient's participation in the licensed substance abuse treatment program described
268     in Subsection (2)(p)(i)(A);
269          (ii) the information is sought for the purpose of determining whether the patient is
270     using a controlled substance while the patient is enrolled in the licensed substance abuse
271     treatment program described in Subsection (2)(p)(i)(A); and
272          (iii) the licensed substance abuse treatment program described in Subsection
273     (2)(p)(i)(A) is associated with a practitioner who:

274          (A) is a physician, a physician assistant, an advance practice registered nurse, or a
275     pharmacist; and
276          (B) is available to consult with the mental health therapist regarding the information
277     obtained by the mental health therapist, under this Subsection (2)(p), from the database;
278          (q) an individual who is the recipient of a controlled substance prescription entered into
279     the database, upon providing evidence satisfactory to the division that the individual requesting
280     the information is in fact the individual about whom the data entry was made;
281          (r) an individual under Subsection (2)(q) for the purpose of obtaining a list of the
282     persons and entities that have requested or received any information from the database
283     regarding the individual, except if the individual's record is subject to a pending or current
284     investigation as authorized under this Subsection (2);
285          (s) the inspector general, or a designee of the inspector general, of the Office of
286     Inspector General of Medicaid Services, for the purpose of fulfilling the duties described in
287     Title 63A, Chapter 13, Part 2, Office and Powers; [and]
288          (t) the following licensed physicians for the purpose of reviewing and offering an
289     opinion on an individual's request for workers' compensation benefits under Title 34A, Chapter
290     2, Workers' Compensation Act, or Title 34A, Chapter 3, Utah Occupational Disease Act:
291          (i) a member of the medical panel described in Section 34A-2-601;
292          (ii) a physician employed as medical director for a licensed workers' compensation
293     insurer or an approved self-insured employer; or
294          (iii) a physician offering a second opinion regarding treatment[.]; and
295          (u) members of Utah's Opioid Fatality Review Committee, for the purpose of
296     reviewing a specific fatality due to opioid use and recommending policies to reduce the
297     frequency of opioid use fatalities.
298          (3) (a) (i) A practitioner described in Subsection (2)(h) may designate one or more
299     employees to access information from the database under Subsection (2)(i), (2)(j), or (4)(c).
300          (ii) A pharmacist described in Subsection (2)(k) who is a pharmacist-in-charge may
301     designate up to five employees to access information from the database under Subsection (2)(l).
302          (b) The division shall make rules, in accordance with Title 63G, Chapter 3, Utah
303     Administrative Rulemaking Act, to:
304          (i) establish background check procedures to determine whether an employee

305     designated under Subsection (2)(i), (2)(j), or (4)(c) should be granted access to the database;
306     and
307          (ii) establish the information to be provided by an emergency department employee
308     under Subsection (4); and
309          (iii) facilitate providing controlled substance prescription information to a third party
310     under Subsection (5).
311          (c) The division shall grant an employee designated under Subsection (2)(i), (2)(j), or
312     (4)(c) access to the database, unless the division determines, based on a background check, that
313     the employee poses a security risk to the information contained in the database.
314          (4) (a) An individual who is employed in the emergency department of a hospital may
315     exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if
316     the individual is designated under Subsection (4)(c) and the licensed practitioner:
317          (i) is employed in the emergency department;
318          (ii) is treating an emergency department patient for an emergency medical condition;
319     and
320          (iii) requests that an individual employed in the emergency department and designated
321     under Subsection (4)(c) obtain information regarding the patient from the database as needed in
322     the course of treatment.
323          (b) The emergency department employee obtaining information from the database
324     shall, when gaining access to the database, provide to the database the name and any additional
325     identifiers regarding the requesting practitioner as required by division administrative rule
326     established under Subsection (3)(b).
327          (c) An individual employed in the emergency department under this Subsection (4)
328     may obtain information from the database as provided in Subsection (4)(a) if:
329          (i) the employee is designated by the practitioner as an individual authorized to access
330     the information on behalf of the practitioner;
331          (ii) the practitioner and the hospital operating the emergency department provide
332     written notice to the division of the identity of the designated employee; and
333          (iii) the division:
334          (A) grants the employee access to the database; and
335          (B) provides the employee with a password that is unique to that employee to access

336     the database in order to permit the division to comply with the requirements of Subsection
337     58-37f-203(5) with respect to the employee.
338          (d) The division may impose a fee, in accordance with Section 63J-1-504, on a
339     practitioner who designates an employee under Subsection (2)(i), (2)(j), or (4)(c) to pay for the
340     costs incurred by the division to conduct the background check and make the determination
341     described in Subsection (3)(b).
342          (5) (a) (i) An individual may request that the division provide the information under
343     Subsection (5)(b) to a third party who is designated by the individual each time a controlled
344     substance prescription for the individual is dispensed.
345          (ii) The division shall upon receipt of the request under this Subsection (5)(a) advise
346     the individual in writing that the individual may direct the division to discontinue providing the
347     information to a third party and that notice of the individual's direction to discontinue will be
348     provided to the third party.
349          (b) The information the division shall provide under Subsection (5)(a) is:
350          (i) the fact a controlled substance has been dispensed to the individual, but without
351     identifying the controlled substance; and
352          (ii) the date the controlled substance was dispensed.
353          (c) (i) An individual who has made a request under Subsection (5)(a) may direct that
354     the division discontinue providing information to the third party.
355          (ii) The division shall:
356          (A) notify the third party that the individual has directed the division to no longer
357     provide information to the third party; and
358          (B) discontinue providing information to the third party.
359          (6) (a) An individual who is granted access to the database based on the fact that the
360     individual is a licensed practitioner or a mental health therapist shall be denied access to the
361     database when the individual is no longer licensed.
362          (b) An individual who is granted access to the database based on the fact that the
363     individual is a designated employee of a licensed practitioner shall be denied access to the
364     database when the practitioner is no longer licensed.
365          (7) A probation or parole officer is not required to obtain a search warrant to access the
366     database in accordance with Subsection (2)(n).

367          (8) The division shall review and adjust the database programming which
368     automatically logs off an individual who is granted access to the database under Subsections
369     (2)(h), (2)(i), (2)(j), and (4)(c) to maximize the following objectives:
370          (a) to protect patient privacy;
371          (b) to reduce inappropriate access; and
372          (c) to make the database more useful and helpful to a person accessing the database
373     under Subsections (2)(h), (2)(i), (2)(j), and (4)(c), especially in high usage locations such as an
374     emergency department.
375          Section 3. Section 58-37f-602 is amended to read:
376          58-37f-602. Failure by pharmacist to submit information -- Penalties.
377          (1) The failure of a [pharmacist in charge] pharmacist-in-charge, a pharmacy, or a third
378     party under contract with a pharmacist-in-charge to submit information to the database [as
379     required under] in accordance with the requirements of Section 58-37f-203, after the division
380     has submitted a specific written request for the information or when the division determines the
381     [individual] pharmacist-in-charge, pharmacy, or third party has a demonstrable pattern of
382     failing to submit the information as required, is grounds for the division to take the following
383     actions in accordance with Section 58-1-401:
384          (a) refuse to issue a license to the [individual] pharmacist-in-charge or the pharmacy;
385          (b) refuse to renew the [individual's] license of the pharmacist-in-charge or the
386     pharmacy;
387          (c) revoke, suspend, restrict, or place on probation the license of the
388     pharmacist-in-charge or the pharmacy;
389          (d) issue a public reprimand to the [individual] pharmacist-in-charge or the pharmacy;
390          (e) issue a cease and desist order to the pharmacist-in-charge, the pharmacy, or the
391     third party; and
392          (f) impose a civil penalty on the pharmacist-in-charge, the pharmacy, or the third party
393     of [not more than] up to $1,000 for each dispensed prescription regarding which the required
394     information is not submitted in accordance with the requirements of Section 58-37f-203.
395          (2) Civil penalties assessed under Subsection (1)(f) shall be deposited in the General
396     Fund as a dedicated credit to be used by the division under Subsection 58-37f-502(1).
397          (3) The procedure for determining a civil violation of this section shall be in

398     accordance with Section 58-1-108, regarding adjudicative proceedings within the division.