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H.B. 6 Enrolled

             1     

CONTROLLED SUBSTANCE DATABASE

             2     
AMENDMENTS

             3     
2007 GENERAL SESSION

             4     
STATE OF UTAH

             5     
Chief Sponsor: Ronda Rudd Menlove

             6     
Senate Sponsor: Peter C. Knudson

             7     
             8      LONG TITLE
             9      General Description:
             10          This bill amends the Utah Controlled Substances Act.
             11      Highlighted Provisions:
             12          This bill:
             13          .    provides limited access to the Controlled Substance Database for:
             14              .    practitioners, for the purpose of inquiring whether the practitioner's DEA
             15      number has been fraudulently used by another person; and
             16              .    law enforcement authorities investigating insurance, Medicaid, or Medicare
             17      fraud.
             18      Monies Appropriated in this Bill:
             19          None
             20      Other Special Clauses:
             21          None
             22      Utah Code Sections Affected:
             23      AMENDS:
             24          58-37-7.5, as last amended by Chapter 46, Laws of Utah 2006
             25     
             26      Be it enacted by the Legislature of the state of Utah:
             27          Section 1. Section 58-37-7.5 is amended to read:
             28           58-37-7.5. Controlled substance database -- Pharmacy reporting requirements --
             29      Access -- Penalties.


             30          (1) As used in this section:
             31          (a) "Database" means the controlled substance database created in this section.
             32          (b) "Database manager" means the person responsible for operating the database, or his
             33      designee.
             34          (c) "Division" means the Division of Occupational and Professional Licensing created
             35      in Section 58-1-103 .
             36          (d) "Health care facility" has the same definition as in Section 26-21-2 .
             37          (e) "Pharmacy or pharmaceutical facility" has the same definition as in Section
             38      58-17b-102 .
             39          (2) (a) There is created within the division a controlled substance database.
             40          (b) The division shall administer and direct the functioning of the database in
             41      accordance with this section. The division may under state procurement laws contract with
             42      another state agency or private entity to establish, operate, or maintain the database. The
             43      division in collaboration with the board shall determine whether to operate the database within
             44      the division or contract with another entity to operate the database, based on an analysis of
             45      costs and benefits.
             46          (c) The purpose of the database is to contain data as described in this section regarding
             47      every prescription for a controlled substance dispensed in the state to any person other than an
             48      inpatient in a licensed health care facility.
             49          (d) Data required by this section shall be submitted in compliance with this section to
             50      the manager of the database by the pharmacist in charge of the drug outlet where the controlled
             51      substance is dispensed.
             52          (3) The Utah State Board of Pharmacy created in Section 58-17b-201 shall advise the
             53      division regarding:
             54          (a) establishing, maintaining, and operating the database;
             55          (b) access to the database and how access is obtained; and
             56          (c) control of information contained in the database.
             57          (4) The pharmacist in charge shall, regarding each controlled substance dispensed by a


             58      pharmacist under his supervision other than those dispensed for an inpatient at a health care
             59      facility, submit to the manager of the database the following information, by a procedure and in
             60      a format established by the division:
             61          (a) name of the prescribing practitioner;
             62          (b) date of the prescription;
             63          (c) date the prescription was filled;
             64          (d) name of the person for whom the prescription was written;
             65          (e) positive identification of the person receiving the prescription, including the type of
             66      identification and any identifying numbers on the identification;
             67          (f) name of the controlled substance;
             68          (g) quantity of controlled substance prescribed;
             69          (h) strength of controlled substance;
             70          (i) quantity of controlled substance dispensed;
             71          (j) dosage quantity and frequency as prescribed;
             72          (k) name of drug outlet dispensing the controlled substance;
             73          (l) name of pharmacist dispensing the controlled substance; and
             74          (m) other relevant information as required by division rule.
             75          (5) The division shall maintain the database in an electronic file or by other means
             76      established by the division to facilitate use of the database for identification of:
             77          (a) prescribing practices and patterns of prescribing and dispensing controlled
             78      substances;
             79          (b) practitioners prescribing controlled substances in an unprofessional or unlawful
             80      manner;
             81          (c) individuals receiving prescriptions for controlled substances from licensed
             82      practitioners, and who subsequently obtain dispensed controlled substances from a drug outlet
             83      in quantities or with a frequency inconsistent with generally recognized standards of dosage for
             84      that controlled substance; and
             85          (d) individuals presenting forged or otherwise false or altered prescriptions for


             86      controlled substances to a pharmacy.
             87          (6) (a) The division shall by rule establish the electronic format in which the
             88      information required under this section shall be submitted to the administrator of the database.
             89          (b) The division shall ensure the database system records and maintains for reference:
             90          (i) identification of each person who requests or receives information from the
             91      database;
             92          (ii) the information provided to each person; and
             93          (iii) the date and time the information is requested or provided.
             94          (7) The division shall make rules to:
             95          (a) effectively enforce the limitations on access to the database as described in
             96      Subsection (8); and
             97          (b) establish standards and procedures to ensure accurate identification of individuals
             98      requesting information or receiving information without request from the database.
             99          (8) The manager of the database shall make information in the database available only
             100      to the following persons, and in accordance with the limitations stated and division rules:
             101          (a) personnel of the division specifically assigned to conduct investigations related to
             102      controlled substances laws under the jurisdiction of the division;
             103          (b) authorized division personnel engaged in analysis of controlled substance
             104      prescription information as a part of the assigned duties and responsibilities of their
             105      employment;
             106          (c) employees of the Department of Health whom the director of the Department of
             107      Health assigns to conduct scientific studies regarding the use or abuse of controlled substances,
             108      provided that the identity of the individuals and pharmacies in the database are confidential and
             109      are not disclosed in any manner to any individual who is not directly involved in the scientific
             110      studies;
             111          (d) a licensed practitioner having authority to prescribe controlled substances, to the
             112      extent:
             113          (i) the information relates specifically to a current patient of the practitioner, to whom


             114      the practitioner is prescribing or considering prescribing any controlled substance;
             115          (ii) the information relates specifically to an individual who has access to the
             116      practitioner's Drug Enforcement Administration number, and the practitioner suspects that the
             117      individual may have used the practitioner's Drug Enforcement Administration identification
             118      number to fraudulently acquire or prescribe controlled substances; or
             119          (iii) the information relates to the practitioner's own prescribing practices, except when
             120      specifically prohibited by the division by administrative rule;
             121          (e) a licensed pharmacist having authority to dispense controlled substances to the
             122      extent the information relates specifically to a current patient to whom that pharmacist is
             123      dispensing or considering dispensing any controlled substance;
             124          (f) federal, state, and local law enforcement authorities engaged as a specified duty of
             125      their employment in enforcing laws:
             126          (i) regulating controlled substances; [and] or
             127          (ii) investigating insurance fraud, Medicaid fraud, or Medicare fraud; and
             128          (g) an individual who is the recipient of a controlled substance prescription entered into
             129      the database, upon providing evidence satisfactory to the database manager that the individual
             130      requesting the information is in fact the person about whom the data entry was made.
             131          (9) Any person who knowingly and intentionally releases any information in the
             132      database in violation of the limitations under Subsection (8) is guilty of a third degree felony.
             133          (10) Any person who obtains or attempts to obtain information from the database by
             134      misrepresentation or fraud is guilty of a third degree felony.
             135          (11) (a) A person may not knowingly and intentionally use, release, publish, or
             136      otherwise make available to any other person or entity any information obtained from the
             137      database for any purpose other than those specified in Subsection (8). Each separate violation
             138      of this Subsection (11) is a third degree felony and is also subject to a civil penalty not to
             139      exceed $5,000.
             140          (b) The procedure for determining a civil violation of this Subsection (11) shall be in
             141      accordance with Section 58-1-108 , regarding adjudicative proceedings within the division.


             142          (c) Civil penalties assessed under this Subsection (11) shall be deposited in the General
             143      Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
             144          (12) (a) The failure of a pharmacist in charge to submit information to the database as
             145      required under this section after the division has submitted a specific written request for the
             146      information or when the division determines the individual has a demonstrable pattern of
             147      failing to submit the information as required is grounds for the division to take the following
             148      actions in accordance with Section 58-1-401 :
             149          (i) refuse to issue a license to the individual;
             150          (ii) refuse to renew the individual's license;
             151          (iii) revoke, suspend, restrict, or place on probation the license;
             152          (iv) issue a public or private reprimand to the individual;
             153          (v) issue a cease and desist order; and
             154          (vi) impose a civil penalty of not more than $1,000 for each dispensed prescription
             155      regarding which the required information is not submitted.
             156          (b) Civil penalties assessed under Subsection (12)(a)(vi) shall be deposited in the
             157      General Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
             158          (c) The procedure for determining a civil violation of this Subsection (12) shall be in
             159      accordance with Section 58-1-108 , regarding adjudicative proceedings within the division.
             160          (13) An individual who has submitted information to the database in accordance with
             161      this section may not be held civilly liable for having submitted the information.
             162          (14) All department and the division costs necessary to establish and operate the
             163      database shall be funded by appropriations from:
             164          (a) the Commerce Service Fund; and
             165          (b) the General Fund.
             166          (15) All costs associated with recording and submitting data as required in this section
             167      shall be assumed by the submitting pharmacy.


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