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H.B. 106

             1     

CONTROLLED SUBSTANCE DATABASE

             2     
AMENDMENTS

             3     
2009 GENERAL SESSION

             4     
STATE OF UTAH

             5     
Chief Sponsor: Bradley M. Daw

             6     
Senate Sponsor: Curtis S. Bramble

             7     
             8      LONG TITLE
             9      General Description:
             10          This bill amends provisions of the Utah Controlled Substances Act relating to the
             11      controlled substance database.
             12      Highlighted Provisions:
             13          This bill:
             14          .    defines terms;
             15          .    expands the purposes for which a practitioner or pharmacist may access information
             16      on the controlled substance database;
             17          .    grants access to the controlled substance database to a mental health therapist under
             18      certain circumstances;
             19          .    permits a practitioner to designate up to three employees, subject to approval by the
             20      Division of Occupational and Professional Licensing, who can access the controlled
             21      substance database on the practitioner's behalf;
             22          .    provides that a practitioner, or an employee of the practitioner, who obtains
             23      information from the controlled substance database may include the information in
             24      the patient's medical chart or file and may provide the information to others in
             25      accordance with the requirements of the Health Insurance Portability and
             26      Accountability Act of 1996;
             27          .    grants rulemaking authority to the Division of Occupational and Professional


             28      Licensing;
             29          .    permits the Division of Occupational and Professional Licensing to impose a fee on
             30      practitioners who designate an employee to access the controlled substance
             31      database, in order to recover the cost of determining whether the employee is a
             32      security risk;
             33          .    provides that a person who is a licensed practitioner or a mental health therapist
             34      shall be denied access to the database when the person is no longer licensed;
             35          .    provides that a person who is a relative of a deceased individual is not entitled to
             36      access information from the database relating to the deceased individual based on
             37      the fact or claim that the person is related to, or subrogated to the rights of, the
             38      deceased individual; and
             39          .    makes technical changes.
             40      Monies Appropriated in this Bill:
             41          None
             42      Other Special Clauses:
             43          None
             44      Utah Code Sections Affected:
             45      AMENDS:
             46          58-37-7.5, as last amended by Laws of Utah 2008, Chapter 313
             47     
             48      Be it enacted by the Legislature of the state of Utah:
             49          Section 1. Section 58-37-7.5 is amended to read:
             50           58-37-7.5. Controlled substance database -- Pharmacy reporting requirements --
             51      Access -- Penalties.
             52          (1) As used in this section:
             53          (a) "Board" means the Utah State Board of Pharmacy created in Section 58-17b-201 .
             54          (b) "Database" means the controlled substance database created in this section.
             55          (c) "Database manager" means the person responsible for operating the database, or the
             56      person's designee.
             57          (d) "Division" means the Division of Occupational and Professional Licensing created
             58      in Section 58-1-103 .


             59          (e) "Health care facility" is as defined in Section 26-21-2 .
             60          (f) "Mental health therapist" is as defined in Section 58-60-102 .
             61          [(f)] (g) "Pharmacy" or "pharmaceutical facility" is as defined in Section 58-17b-102 .
             62          (h) "Prospective patient" means a person who:
             63          (i) is seeking medical advice, medical treatment, or medical services from a
             64      practitioner; and
             65          (ii) the practitioner described in Subsection (1)(h)(i) is considering accepting as a
             66      patient.
             67          (i) "Substance abuse treatment program" is as defined in Section 62A-2-101 .
             68          (2) (a) There is created within the division a controlled substance database.
             69          (b) The division shall administer and direct the functioning of the database in
             70      accordance with this section. The division may under state procurement laws contract with
             71      another state agency or private entity to establish, operate, or maintain the database. The
             72      division in collaboration with the board shall determine whether to operate the database within
             73      the division or contract with another entity to operate the database, based on an analysis of
             74      costs and benefits.
             75          (c) The purpose of the database is to contain data as described in this section regarding
             76      every prescription for a controlled substance dispensed in the state to any person other than an
             77      inpatient in a licensed health care facility.
             78          (d) Data required by this section shall be submitted in compliance with this section to
             79      the manager of the database by the pharmacist in charge of the drug outlet where the controlled
             80      substance is dispensed.
             81          (3) The board shall advise the division regarding:
             82          (a) establishing, maintaining, and operating the database;
             83          (b) access to the database and how access is obtained; and
             84          (c) control of information contained in the database.
             85          (4) The pharmacist in charge shall, regarding each controlled substance dispensed by a
             86      pharmacist under the pharmacist's supervision other than those dispensed for an inpatient at a
             87      health care facility, submit to the manager of the database the following information, by a
             88      procedure and in a format established by the division:
             89          (a) name of the prescribing practitioner;


             90          (b) date of the prescription;
             91          (c) date the prescription was filled;
             92          (d) name of the person for whom the prescription was written;
             93          (e) positive identification of the person receiving the prescription, including the type of
             94      identification and any identifying numbers on the identification;
             95          (f) name of the controlled substance;
             96          (g) quantity of controlled substance prescribed;
             97          (h) strength of controlled substance;
             98          (i) quantity of controlled substance dispensed;
             99          (j) dosage quantity and frequency as prescribed;
             100          (k) name of drug outlet dispensing the controlled substance;
             101          (l) name of pharmacist dispensing the controlled substance; and
             102          (m) other relevant information as required by division rule.
             103          (5) The division shall maintain the database in an electronic file or by other means
             104      established by the division to facilitate use of the database for identification of:
             105          (a) prescribing practices and patterns of prescribing and dispensing controlled
             106      substances;
             107          (b) practitioners prescribing controlled substances in an unprofessional or unlawful
             108      manner;
             109          (c) individuals receiving prescriptions for controlled substances from licensed
             110      practitioners, and who subsequently obtain dispensed controlled substances from a drug outlet
             111      in quantities or with a frequency inconsistent with generally recognized standards of dosage for
             112      that controlled substance; and
             113          (d) individuals presenting forged or otherwise false or altered prescriptions for
             114      controlled substances to a pharmacy.
             115          (6) (a) The division shall by rule establish the electronic format in which the
             116      information required under this section shall be submitted to the administrator of the database.
             117          (b) The division shall ensure the database system records and maintains for reference:
             118          (i) identification of each person who requests or receives information from the
             119      database;
             120          (ii) the information provided to each person; and


             121          (iii) the date and time the information is requested or provided.
             122          (7) The division shall make rules to:
             123          (a) effectively enforce the limitations on access to the database as described in
             124      Subsection (8); and
             125          (b) establish standards and procedures to ensure accurate identification of individuals
             126      requesting information or receiving information without request from the database.
             127          (8) The manager of the database shall make information in the database available only
             128      to the following persons, [and] in accordance with the [limitations stated] requirements of this
             129      section and division rules:
             130          (a) personnel of the division specifically assigned to conduct investigations related to
             131      controlled substances laws under the jurisdiction of the division;
             132          (b) authorized division personnel engaged in analysis of controlled substance
             133      prescription information as a part of the assigned duties and responsibilities of their
             134      employment;
             135          (c) employees of the Department of Health whom the director of the Department of
             136      Health assigns to conduct scientific studies regarding the use or abuse of controlled substances,
             137      provided that the identity of the individuals and pharmacies in the database are confidential and
             138      are not disclosed in any manner to any individual who is not directly involved in the scientific
             139      studies;
             140          (d) a licensed practitioner having authority to prescribe controlled substances, to the
             141      extent the information:
             142          (i) (A) [the information] relates specifically to a current or prospective patient of the
             143      practitioner[, to whom the practitioner is]; and
             144          (B) is sought by the practitioner for the purpose of:
             145          (I) prescribing or considering prescribing any controlled substance[;] to the current or
             146      prospective patient;
             147          (II) diagnosing the current or prospective patient;
             148          (III) providing medical treatment or medical advice to the current or prospective
             149      patient; or
             150          (IV) determining whether the current or prospective patient:
             151          (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner;


             152      or
             153          (Bb) has fraudulently obtained, or attempted to fraudulently obtain, a controlled
             154      substance from the practitioner;
             155          (ii) (A) relates specifically to a former patient of the practitioner; and
             156          (B) is sought by the practitioner for the purpose of determining whether the former
             157      patient has fraudulently obtained, or has attempted to fraudulently obtain, a controlled
             158      substance from the practitioner;
             159          [(ii) the information] (iii) relates specifically to an individual who has access to the
             160      practitioner's Drug Enforcement Administration number, and the practitioner suspects that the
             161      individual may have used the practitioner's Drug Enforcement Administration identification
             162      number to fraudulently acquire or prescribe a controlled [substances; or] substance;
             163          [(iii) the information] (iv) relates to the practitioner's own prescribing practices, except
             164      when specifically prohibited by the division by administrative rule;
             165          (v) relates to the use of the controlled substance database by an employee of the
             166      practitioner, described in Subsection (8)(e); or
             167          (vi) relates to any use of the practitioner's Drug Enforcement Administration
             168      identification number to obtain, attempt to obtain, prescribe, or attempt to prescribe, a
             169      controlled substance;
             170          (e) in accordance with Subsection (17), an employee of a practitioner described in
             171      Subsection (8)(d), for a purpose described in Subsection (8)(d)(i) or (ii), if:
             172          (i) the employee is designated by the practitioner as a person authorized to access the
             173      information on behalf of the practitioner;
             174          (ii) the practitioner provides written notice to the division of the identity of the
             175      employee; and
             176          (iii) the division:
             177          (A) grants the employee access to the database; and
             178          (B) provides the employee with a unique password to access the database in order to
             179      permit the division to comply with the requirements of Subsection (6)(b) with respect to the
             180      employee;
             181          [(e)] (f) a licensed pharmacist having authority to dispense controlled substances to the
             182      extent the information [relates specifically to a current patient to whom that pharmacist is] is


             183      sought for the purpose of:
             184          (i) dispensing or considering dispensing any controlled substance; or
             185          (ii) determining whether a person:
             186          (A) is attempting to fraudulently obtain a controlled substance from the pharmacist; or
             187          (B) has fraudulently obtained, or attempted to fraudulently obtain, a controlled
             188      substance from the pharmacist;
             189          [(f)] (g) federal, state, and local law enforcement authorities, and state and local
             190      prosecutors, engaged as a specified duty of their employment in enforcing laws:
             191          (i) regulating controlled substances; or
             192          (ii) investigating insurance fraud, Medicaid fraud, or Medicare fraud; [and]
             193          (h) a mental heath therapist, if:
             194          (i) the information relates to a patient who is:
             195          (A) enrolled in a licensed substance abuse treatment program; and
             196          (B) receiving treatment from, or under the direction of, the mental health therapist as
             197      part of the patient's participation in the licensed substance abuse treatment program described
             198      in Subsection (8)(h)(i)(A);
             199          (ii) the information is sought for the purpose of determining whether the patient is
             200      using a controlled substance while the patient is enrolled in the licensed substance abuse
             201      treatment program described in Subsection (8)(h)(i)(A); and
             202          (iii) the licensed substance abuse treatment program described in Subsection
             203      (8)(h)(i)(A) is associated with a practitioner who:
             204          (A) is a physician, a physician assistant, an advance practice registered nurse, or a
             205      pharmacist; and
             206          (B) is available to consult with the mental health therapist regarding the information
             207      obtained by the mental health therapist, under this Subsection (8)(h), from the database; and
             208          [(g)] (i) an individual who is the recipient of a controlled substance prescription
             209      entered into the database, upon providing evidence satisfactory to the database manager that the
             210      individual requesting the information is in fact the person about whom the data entry was
             211      made.
             212          (9) Any person who knowingly and intentionally releases any information in the
             213      database in violation of the limitations under Subsection (8) is guilty of a third degree felony.


             214          (10) (a) Any person who obtains or attempts to obtain information from the database
             215      by misrepresentation or fraud is guilty of a third degree felony.
             216          (b) Any person who obtains or attempts to obtain information from the database for a
             217      purpose other than a purpose authorized by this section or by rule is guilty of a third degree
             218      felony.
             219          (11) (a) [A] Except as provided in Subsection (11)(d), a person may not knowingly and
             220      intentionally use, release, publish, or otherwise make available to any other person or entity any
             221      information obtained from the database for any purpose other than those specified in
             222      Subsection (8). Each separate violation of this Subsection (11) is a third degree felony and is
             223      also subject to a civil penalty not to exceed $5,000.
             224          (b) The procedure for determining a civil violation of this Subsection (11) shall be in
             225      accordance with Section 58-1-108 , regarding adjudicative proceedings within the division.
             226          (c) Civil penalties assessed under this Subsection (11) shall be deposited in the General
             227      Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
             228          (d) Nothing in this Subsection (11) prohibits a person who obtains information from
             229      the database under Subsection (8)(d) or (e) from:
             230          (i) including the information in the person's medical chart or file for access by a person
             231      authorized to review the medical chart or file; or
             232          (ii) providing the information to a person in accordance with the requirements of the
             233      Health Insurance Portability and Accountability Act of 1996.
             234          (12) (a) The failure of a pharmacist in charge to submit information to the database as
             235      required under this section after the division has submitted a specific written request for the
             236      information or when the division determines the individual has a demonstrable pattern of
             237      failing to submit the information as required is grounds for the division to take the following
             238      actions in accordance with Section 58-1-401 :
             239          (i) refuse to issue a license to the individual;
             240          (ii) refuse to renew the individual's license;
             241          (iii) revoke, suspend, restrict, or place on probation the license;
             242          (iv) issue a public or private reprimand to the individual;
             243          (v) issue a cease and desist order; and
             244          (vi) impose a civil penalty of not more than $1,000 for each dispensed prescription


             245      regarding which the required information is not submitted.
             246          (b) Civil penalties assessed under Subsection (12)(a)(vi) shall be deposited in the
             247      General Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
             248          (c) The procedure for determining a civil violation of this Subsection (12) shall be in
             249      accordance with Section 58-1-108 , regarding adjudicative proceedings within the division.
             250          (13) An individual who has submitted information to the database in accordance with
             251      this section may not be held civilly liable for having submitted the information.
             252          (14) All department and the division costs necessary to establish and operate the
             253      database shall be funded by appropriations from:
             254          (a) the Commerce Service Fund; and
             255          (b) the General Fund.
             256          (15) All costs associated with recording and submitting data as required in this section
             257      shall be assumed by the submitting pharmacy.
             258          (16) (a) Except as provided in Subsection (16)(b), data provided to, maintained in, or
             259      accessed from the database that may be identified to, or with, a particular person is not subject
             260      to discovery, subpoena, or similar compulsory process in any civil, judicial, administrative, or
             261      legislative proceeding, nor shall any individual or organization with lawful access to the data
             262      be compelled to testify with regard to the data.
             263          (b) The restrictions in Subsection (16)(a) do not apply to:
             264          (i) a criminal proceeding; or
             265          (ii) a civil, judicial, or administrative action brought to enforce the provisions of this
             266      section, Section 58-37-7.7 , or Section 58-37-7.8 .
             267          (17) (a) A practitioner described in Subsection (8)(d) may designate up to three
             268      employees to access information from the database under Subsection (8)(e).
             269          (b) The division shall make rules, in accordance with Title 63G, Chapter 3, Utah
             270      Administrative Rulemaking Act, to establish background check procedures to determine
             271      whether an employee designated under Subsection (8)(e)(i) should be granted access to the
             272      database.
             273          (c) The division shall grant an employee designated under Subsection (8)(e)(i) access
             274      to the database, unless the division determines, based on a background check, that the
             275      employee poses a security risk to the information contained in the database.


             276          (d) The division may impose a fee, in accordance with Section 63J-1-303 , on a
             277      practitioner who designates an employee under Subsection (8)(e)(i), to pay for the costs
             278      incurred by the division to conduct the background check and make the determination
             279      described in Subsection (17)(c).
             280          (18) (a) A person who is granted access to the database based on the fact that the
             281      person is a licensed practitioner or a mental health therapist shall be denied access to the
             282      database when the person is no longer licensed.
             283          (b) A person who is granted access to the database based on the fact that the person is a
             284      designated employee of a licensed practitioner shall be denied access to the database when the
             285      practitioner is no longer licensed.
             286          (19) A person who is a relative of a deceased individual is not entitled to access
             287      information from the database relating to the deceased individual based on the fact or claim
             288      that the person is:
             289          (a) related to the deceased individual; or
             290          (b) subrogated to the rights of the deceased individual.




Legislative Review Note
    as of 1-15-09 12:46 PM


Office of Legislative Research and General Counsel


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