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Sec. 6. Minnesota Statutes 2006, section 152.11, is amended by adding a subdivision to
366.34read:
Subd. 2d. Identification requirement for schedule II or III controlled substance.
No person may dispense a controlled substance included in schedule II or III without
367.3requiring the person purchasing the controlled substance, who need not be the person for
367.4whom the controlled substance prescription is written, to present valid photographic
367.5identification, unless the person purchasing the controlled substance, or if applicable the
367.6person for whom the controlled substance prescription is written, is known to the dispenser.
367.1
367.2
Sec. 7. [152.126] SCHEDULE II AND III CONTROLLED SUBSTANCES
367.8PRESCRIPTION ELECTRONIC REPORTING SYSTEM.
367.9 Subdivision 1. Definitions. For purposes of this section, the terms defined in this
367.10subdivision have the meanings given.
367.11 (a) "Board" means the Minnesota State Board of Pharmacy established under
367.12chapter 151.
367.13 (b) "Controlled substances" means those substances listed in section 152.02,
367.14subdivisions 3 and 4, and those substances defined by the board pursuant to section
367.15152.02, subdivisions 7, 8, and 12.
367.16 (c) "Dispense" or "dispensing" has the meaning given in section 151.01, subdivision
367.1730. Dispensing does not include the direct administering of a controlled substance to a
367.18patient by a licensed health care professional.
367.19 (d) "Dispenser" means a person authorized by law to dispense a controlled substance,
367.20pursuant to a valid prescription. A dispenser does not include a licensed hospital pharmacy
367.21that distributes controlled substances for inpatient hospital care.
367.22 (e) "Prescriber" means a licensed health care professional who is authorized to
367.23prescribe a controlled substance under section 152.12, subdivision 1.
367.24 (f) "Prescription" has the meaning given in section 151.01, subdivision 16.
367.25 Subd. 2. Prescription electronic reporting system. (a) The board shall establish
367.26by January 1, 2009, an electronic system for reporting the information required under
367.27subdivision 4 for all controlled substances dispensed within the state. Data for controlled
367.28substance prescriptions that are dispensed in a quantity small enough to provide treatment
367.29to a patient for a period of 48 hours or less need not be reported.
367.30 (b) The board may contract with a vendor for the purpose of obtaining technical
367.31assistance in the design, implementation, and maintenance of the electronic reporting
367.32system. The vendor's role shall be limited to providing technical support to the board
367.33concerning the software, databases, and computer systems required to interface with the
367.34existing systems currently used by pharmacies to dispense prescriptions and transmit
367.35prescription data to other third parties.
368.1 Subd. 3. Prescription Electronic Reporting Advisory Committee. (a) The
368.2board shall convene an advisory committee. The committee must include at least one
368.3representative of:
368.4 (1) the Department of Health;
368.5 (2) the Department of Human Services;
368.6 (3) each health-related licensing board that licenses prescribers;
368.7 (4) a professional medical association, which may include an association of pain
368.8management and chemical dependency specialists;
368.9 (5) a professional pharmacy association;
368.10 (6) a consumer privacy or security advocate; and
368.11 (7) a consumer or patient rights organization.
368.12 (b) The advisory committee shall advise the board on the development and operation
368.13of the electronic reporting system, including, but not limited to:
367.7
(1) technical standards for electronic prescription drug reporting;
(2) proper analysis and interpretation of prescription monitoring data; and
368.16 (3) an evaluation process for the program.
368.17 (c) The Board of Pharmacy, after consultation with the advisory committee, shall
368.18present recommendations and draft legislation on the issues addressed by the advisory
368.19committee under paragraph (b), to the legislature by December 15, 2007.
368.20 Subd. 4. Reporting requirements; notice. (a) Each dispenser must submit the
368.21following data to the board or its designated vendor, subject to the notice required under
368.22paragraph (d):
368.23 (1) name of the prescriber;
368.24 (2) national provider identifier of the prescriber;
368.25 (3) name of the dispenser;
368.26 (4) national provider identifier of the dispenser;
368.27 (5) name of the patient for whom the prescription was written;
368.28 (6) date of birth of the patient for whom the prescription was written;
368.29 (7) date the prescription was written;
368.30 (8) date the prescription was filled;
368.31 (9) name and strength of the controlled substance;
368.32 (10) quantity of controlled substance prescribed; and
368.33 (11) quantity of controlled substance dispensed.
368.34 (b) The dispenser must submit the required information by a procedure and in a
368.35format established by the board.
369.1 (c) A dispenser is not required to submit this data for those controlled substance
369.2prescriptions dispensed for:
369.3 (1) individuals residing in licensed skilled nursing or intermediate care facilities;
369.4 (2) individuals receiving assisted living services under chapter 144G or through a
369.5medical assistance home and community-based waiver;
369.6 (3) individuals receiving medication intravenously;
369.7 (4) individuals receiving hospice and other palliative or end-of-life care; and
369.8 (5) individuals receiving services from a home care provider regulated under chapter
369.9144A.
369.10 (d) A dispenser must not submit data under this subdivision unless a conspicuous
369.11notice of the reporting requirements of this section is given to the patient for whom the
369.12prescription was written.
369.13 Subd. 5. Use of data by board. (a) The board shall develop and maintain a database
369.14of the data reported under subdivision 4. The board shall maintain data that could identify
369.15an individual prescriber or dispenser in encrypted form. The database may be used by
369.16permissible users identified under subdivision 6 for the identification of:
369.17 (1) individuals receiving prescriptions for controlled substances from prescribers
369.18who subsequently obtain controlled substances from dispensers in quantities or with
369.19a frequency inconsistent with standards accepted by national and international pain
369.20management associations of dosage for those controlled substances; and
369.21 (2) individuals presenting forged or otherwise false or altered prescriptions for
369.22controlled substances to dispensers.
369.23 (b) No permissible user identified under subdivision 6 may access the database
369.24for the sole purpose of identifying prescribers of controlled substances for unusual or
369.25excessive prescribing patterns without a valid search warrant or court order.
369.26 (c) No personnel of a state or federal occupational licensing board or agency may
369.27access the database for the purpose of obtaining information to be used to initiate or
369.28substantiate a disciplinary action against a prescriber.
369.29 (d) Data reported under subdivision 4 shall be retained by the board in the database
368.14
368.15
369.30for
a 12-month period, and shall be removed from the database 12 months from the date
data was received.
369.32 Subd. 6. Access to reporting system data. (a) Except as indicated in this
369.33subdivision, the data submitted to the board under subdivision 4 is private data on
369.34individuals as defined in section 13.02, subdivision 12, and not subject to public disclosure.
369.35 (b) Except as specified in subdivision 5, the following persons shall be considered
369.36permissible users and may access the data submitted under subdivision 4 in the same or
370.1similar manner, and for the same or similar purposes, as those persons who are authorized
370.2to access similar private data on individuals under federal and state law:
370.3 (1) a prescriber, to the extent the information relates specifically to a current patient
370.4of the prescriber, to whom the practitioner is prescribing or considering prescribing any
370.5controlled substance;
370.6 (2) a dispenser, to the extent the information relates specifically to a current patient
370.7to whom that dispenser is dispensing or considering dispensing any controlled substance;
370.8 (3) an individual who is the recipient of a controlled substance prescription for
370.9which data was submitted under subdivision 4, or a guardian of the individual, parent or
370.10guardian of a minor, or health care agent of the individual acting under a health care
370.11directive under chapter 145C;
370.12 (4) personnel of the board specifically assigned to conduct a bona fide investigation
370.13of a specific licensee;
370.14 (5) personnel of the board engaged in the collection of controlled substance
370.15prescription information as part of the assigned duties and responsibilities under this
370.16section;
370.17 (6) authorized personnel of a vendor under contract with the board who are engaged
370.18in the design, implementation, and maintenance of the electronic reporting system as part
370.19of the assigned duties and responsibilities of their employment, provided that access to data
370.20is limited to the minimum amount necessary to test and maintain the system databases;
370.21 (7) federal, state, and local law enforcement authorities acting pursuant to a valid
370.22search warrant; and
370.23 (8) personnel of the medical assistance program assigned to use the data collected
370.24under this section to identify recipients whose usage of controlled substances may warrant
370.25restriction to a single primary care physician, a single outpatient pharmacy, or a single
370.26hospital.
370.27 For purposes of clause (3), access by an individual includes persons in the definition
370.28of an individual under section 13.02.
370.29 (c) Any permissible user identified in paragraph (b), who directly accesses
370.30the data electronically, shall implement and maintain a comprehensive information
370.31security program that contains administrative, technical, and physical safeguards that
370.32are appropriate to the user's size and complexity, and the sensitivity of the personal
370.33information obtained. The permissible user shall identify reasonably foreseeable internal
370.34and external risks to the security, confidentiality, and integrity of personal information
370.35that could result in the unauthorized disclosure, misuse, or other compromise of the
370.36information and assess the sufficiency of any safeguards in place to control the risks.
371.1 (d) The board shall not release data submitted under this section unless it is provided
371.2with evidence, satisfactory to the board, that the person requesting the information is
371.3entitled to receive the data.
371.4 (e) The board shall not release the name of a prescriber without the written consent
371.5of the prescriber or a valid search warrant or court order. The board shall provide a
371.6mechanism for a prescriber to submit to the board a signed consent authorizing the release
371.7of the prescriber's name when data containing the prescriber's name is requested.
371.8 (f) The board shall maintain a log of all persons who access the data and shall ensure
369.31the
371.9that
any permissible user complies with paragraph (c) prior to attaining direct access to
data.
371.11 Subd. 7. Disciplinary action. (a) A dispenser who knowingly fails to submit data to
371.12the board as required under this section is subject to disciplinary action by the appropriate
371.13health-related licensing board.
371.14 (b) A prescriber or dispenser authorized to access the data who knowingly discloses
371.15the data in violation of state or federal laws relating to the privacy of health care data
371.16shall be subject to disciplinary action by the appropriate health-related licensing board,
371.17and appropriate civil penalties.
371.18 Subd. 8. Evaluation and reporting. (a) The board shall evaluate the prescription
371.19electronic reporting system to determine if the system is cost-effective and whether it is
371.20negatively impacting appropriate prescribing practices of controlled substances. The
371.21board may contract with a vendor to design and conduct the evaluation.
371.22 (b) The board shall submit the evaluation of the system to the legislature by January
371.2315, 2010.
371.24 Subd. 9. Immunity from liability; no requirement to obtain information. (a) A
371.25pharmacist, prescriber, or other dispenser making a report to the program in good faith
371.26under this section is immune from any civil, criminal, or administrative liability, which
371.27might otherwise be incurred or imposed as a result of the report, or on the basis that the
371.28pharmacist or prescriber did or did not seek or obtain or use information from the program.
371.29 (b) Nothing in this section shall require a pharmacist, prescriber, or other dispenser
371.30to obtain information about a patient from the program, and the pharmacist, prescriber,
371.31or other dispenser, if acting in good faith, is immune from any civil, criminal, or
371.32administrative liability that might otherwise be incurred or imposed for requesting,
371.33receiving, or using information from the program.
371.34EFFECTIVE DATE.This section is effective July 1, 2007, or upon receiving
371.35sufficient nonstate funds to implement the prescription electronic reporting program,
371.36whichever is later. In the event that nonstate funds are not secured by the Board of
372.1Pharmacy to adequately fund the implementation of the prescription electronic reporting
372.2program, the board is not required to implement this section without a subsequent
372.3appropriation from the legislature.
371.10the
Sec. 8. Minnesota Statutes 2006, section 152.11, is amended by adding a subdivision to
391.15read:
391.16 Subd. 2d. Identification requirement for schedule II or III controlled substance.
391.17 (a) No person may dispense a controlled substance included in schedule II or III without
391.18requiring the person purchasing the controlled substance, who need not be the person for
391.19whom the controlled substance prescription is written, to present valid photographic
391.20identification, unless the person purchasing the controlled substance, or if applicable the
391.21person for whom the controlled substance prescription is written, is known to the dispenser.
391.22 (b) This subdivision applies only to purchases of controlled substances that are not
391.23covered, in whole or in part, by a health plan company or other third-party payor. The
391.24Board of Pharmacy shall report to the legislature by July 1, 2009, on the effect of this
391.25subdivision. The board shall include in the report the incidence of complaints, if any,
391.26generated by the requirements of this subdivision and whether this subdivision is creating
391.27barriers to pharmaceutical access.
393.17
Sec. 11. [256B.0636] CONTROLLED SUBSTANCE PRESCRIPTIONS; ABUSE
393.18PREVENTION.
The commissioner of human services shall develop and implement a plan to:
(1) review utilization patterns of Minnesota health care program enrollees for
393.21controlled substances listed in section 152.02, subdivisions 3 and 4, and those substances
393.22defined by the Board of Pharmacy under section 152.02, subdivisions 8 and 12;
393.23 (2) develop a mechanism to address abuses both for fee-for-service Minnesota health
393.24care program enrollees and those enrolled in managed care plans; and
393.25 (3) provide education to Minnesota health care program enrollees on the proper use
393.26of controlled substances.
393.27 For purposes of this section, "Minnesota health care program" means medical
393.28assistance, MinnesotaCare, or general assistance medical care.
393.19
393.20