2007 Minnesota Statutes

152.126 SCHEDULE II AND III CONTROLLED SUBSTANCES PRESCRIPTION
ELECTRONIC REPORTING SYSTEM.
    Subdivision 1. Definitions. For purposes of this section, the terms defined in this subdivision
have the meanings given.
    (a) "Board" means the Minnesota State Board of Pharmacy established under chapter 151.
    (b) "Controlled substances" means those substances listed in section 152.02, subdivisions
3 and 4, and those substances defined by the board pursuant to section 152.02, subdivisions 7,
8, and 12.
    (c) "Dispense" or "dispensing" has the meaning given in section 151.01, subdivision 30.
Dispensing does not include the direct administering of a controlled substance to a patient by a
licensed health care professional.
    (d) "Dispenser" means a person authorized by law to dispense a controlled substance,
pursuant to a valid prescription. A dispenser does not include a licensed hospital pharmacy that
distributes controlled substances for inpatient hospital care.
    (e) "Prescriber" means a licensed health care professional who is authorized to prescribe a
controlled substance under section 152.12, subdivision 1.
    (f) "Prescription" has the meaning given in section 151.01, subdivision 16.
    Subd. 2. Prescription electronic reporting system. (a) The board shall establish by January
1, 2009, an electronic system for reporting the information required under subdivision 4 for all
controlled substances dispensed within the state. Data for controlled substance prescriptions that
are dispensed in a quantity small enough to provide treatment to a patient for a period of 48
hours or less need not be reported.
    (b) The board may contract with a vendor for the purpose of obtaining technical assistance in
the design, implementation, and maintenance of the electronic reporting system. The vendor's
role shall be limited to providing technical support to the board concerning the software,
databases, and computer systems required to interface with the existing systems currently used by
pharmacies to dispense prescriptions and transmit prescription data to other third parties.
    Subd. 3. Prescription Electronic Reporting Advisory Committee. (a) The board shall
convene an advisory committee. The committee must include at least one representative of:
    (1) the Department of Health;
    (2) the Department of Human Services;
    (3) each health-related licensing board that licenses prescribers;
    (4) a professional medical association, which may include an association of pain management
and chemical dependency specialists;
    (5) a professional pharmacy association;
    (6) a consumer privacy or security advocate; and
    (7) a consumer or patient rights organization.
    (b) The advisory committee shall advise the board on the development and operation of the
electronic reporting system, including, but not limited to:
    (1) technical standards for electronic prescription drug reporting;
    (2) proper analysis and interpretation of prescription monitoring data; and
    (3) an evaluation process for the program.
    (c) The Board of Pharmacy, after consultation with the advisory committee, shall present
recommendations and draft legislation on the issues addressed by the advisory committee under
paragraph (b), to the legislature by December 15, 2007.
    Subd. 4. Reporting requirements; notice. (a) Each dispenser must submit the following
data to the board or its designated vendor, subject to the notice required under paragraph (d):
    (1) name of the prescriber;
    (2) national provider identifier of the prescriber;
    (3) name of the dispenser;
    (4) national provider identifier of the dispenser;
    (5) name of the patient for whom the prescription was written;
    (6) date of birth of the patient for whom the prescription was written;
    (7) date the prescription was written;
    (8) date the prescription was filled;
    (9) name and strength of the controlled substance;
    (10) quantity of controlled substance prescribed; and
    (11) quantity of controlled substance dispensed.
    (b) The dispenser must submit the required information by a procedure and in a format
established by the board.
    (c) A dispenser is not required to submit this data for those controlled substance prescriptions
dispensed for:
    (1) individuals residing in licensed skilled nursing or intermediate care facilities;
    (2) individuals receiving assisted living services under chapter 144G or through a medical
assistance home and community-based waiver;
    (3) individuals receiving medication intravenously;
    (4) individuals receiving hospice and other palliative or end-of-life care; and
    (5) individuals receiving services from a home care provider regulated under chapter 144A.
    (d) A dispenser must not submit data under this subdivision unless a conspicuous notice
of the reporting requirements of this section is given to the patient for whom the prescription
was written.
    Subd. 5. Use of data by board. (a) The board shall develop and maintain a database of the
data reported under subdivision 4. The board shall maintain data that could identify an individual
prescriber or dispenser in encrypted form. The database may be used by permissible users
identified under subdivision 6 for the identification of:
    (1) individuals receiving prescriptions for controlled substances from prescribers who
subsequently obtain controlled substances from dispensers in quantities or with a frequency
inconsistent with standards accepted by national and international pain management associations
of dosage for those controlled substances; and
    (2) individuals presenting forged or otherwise false or altered prescriptions for controlled
substances to dispensers.
    (b) No permissible user identified under subdivision 6 may access the database for the sole
purpose of identifying prescribers of controlled substances for unusual or excessive prescribing
patterns without a valid search warrant or court order.
    (c) No personnel of a state or federal occupational licensing board or agency may access
the database for the purpose of obtaining information to be used to initiate or substantiate a
disciplinary action against a prescriber.
    (d) Data reported under subdivision 4 shall be retained by the board in the database for a
12-month period, and shall be removed from the database 12 months from the date the data was
received.
    Subd. 6. Access to reporting system data. (a) Except as indicated in this subdivision, the
data submitted to the board under subdivision 4 is private data on individuals as defined in section
13.02, subdivision 12, and not subject to public disclosure.
    (b) Except as specified in subdivision 5, the following persons shall be considered
permissible users and may access the data submitted under subdivision 4 in the same or similar
manner, and for the same or similar purposes, as those persons who are authorized to access
similar private data on individuals under federal and state law:
    (1) a prescriber, to the extent the information relates specifically to a current patient of the
prescriber, to whom the practitioner is prescribing or considering prescribing any controlled
substance;
    (2) a dispenser, to the extent the information relates specifically to a current patient to whom
that dispenser is dispensing or considering dispensing any controlled substance;
    (3) an individual who is the recipient of a controlled substance prescription for which data
was submitted under subdivision 4, or a guardian of the individual, parent or guardian of a minor,
or health care agent of the individual acting under a health care directive under chapter 145C;
    (4) personnel of the board specifically assigned to conduct a bona fide investigation of a
specific licensee;
    (5) personnel of the board engaged in the collection of controlled substance prescription
information as part of the assigned duties and responsibilities under this section;
    (6) authorized personnel of a vendor under contract with the board who are engaged in
the design, implementation, and maintenance of the electronic reporting system as part of the
assigned duties and responsibilities of their employment, provided that access to data is limited to
the minimum amount necessary to test and maintain the system databases;
    (7) federal, state, and local law enforcement authorities acting pursuant to a valid search
warrant; and
    (8) personnel of the medical assistance program assigned to use the data collected under this
section to identify recipients whose usage of controlled substances may warrant restriction to a
single primary care physician, a single outpatient pharmacy, or a single hospital.
    For purposes of clause (3), access by an individual includes persons in the definition of
an individual under section 13.02.
    (c) Any permissible user identified in paragraph (b), who directly accesses the data
electronically, shall implement and maintain a comprehensive information security program that
contains administrative, technical, and physical safeguards that are appropriate to the user's size
and complexity, and the sensitivity of the personal information obtained. The permissible user
shall identify reasonably foreseeable internal and external risks to the security, confidentiality,
and integrity of personal information that could result in the unauthorized disclosure, misuse,
or other compromise of the information and assess the sufficiency of any safeguards in place
to control the risks.
    (d) The board shall not release data submitted under this section unless it is provided with
evidence, satisfactory to the board, that the person requesting the information is entitled to
receive the data.
    (e) The board shall not release the name of a prescriber without the written consent of the
prescriber or a valid search warrant or court order. The board shall provide a mechanism for a
prescriber to submit to the board a signed consent authorizing the release of the prescriber's name
when data containing the prescriber's name is requested.
    (f) The board shall maintain a log of all persons who access the data and shall ensure that any
permissible user complies with paragraph (c) prior to attaining direct access to the data.
    Subd. 7. Disciplinary action. (a) A dispenser who knowingly fails to submit data to
the board as required under this section is subject to disciplinary action by the appropriate
health-related licensing board.
    (b) A prescriber or dispenser authorized to access the data who knowingly discloses the
data in violation of state or federal laws relating to the privacy of health care data shall be
subject to disciplinary action by the appropriate health-related licensing board, and appropriate
civil penalties.
    Subd. 8. Evaluation and reporting. (a) The board shall evaluate the prescription electronic
reporting system to determine if the system is cost-effective and whether it is negatively impacting
appropriate prescribing practices of controlled substances. The board may contract with a vendor
to design and conduct the evaluation.
    (b) The board shall submit the evaluation of the system to the legislature by January 15, 2010.
    Subd. 9. Immunity from liability; no requirement to obtain information. (a) A
pharmacist, prescriber, or other dispenser making a report to the program in good faith under this
section is immune from any civil, criminal, or administrative liability, which might otherwise be
incurred or imposed as a result of the report, or on the basis that the pharmacist or prescriber did
or did not seek or obtain or use information from the program.
    (b) Nothing in this section shall require a pharmacist, prescriber, or other dispenser to obtain
information about a patient from the program, and the pharmacist, prescriber, or other dispenser,
if acting in good faith, is immune from any civil, criminal, or administrative liability that might
otherwise be incurred or imposed for requesting, receiving, or using information from the program.
History: 2007 c 147 art 11 s 7