.................... moves to amend H. F. No. 297, the delete everything amendment
(A07-0645), as follows:
Page 165, after line 18, insert:
"Sec. 5. Minnesota Statutes 2006, section 152.11, is amended by adding a subdivision
1.6 Subd. 2d. Identification requirement for schedule II or III controlled substance.
1.7 No person may dispense a controlled substance included in schedule II or III without
1.8requiring the person purchasing the controlled substance, who need not be the person for
1.9whom the controlled substance prescription is written, to present valid photographic
1.10identification, unless the person purchasing the controlled substance, or if applicable the
1.11person for whom the controlled substance prescription is written, is known to the dispenser.
Sec. 6. [152.126] SCHEDULE II AND III CONTROLLED SUBSTANCES
1.13PRESCRIPTION ELECTRONIC REPORTING SYSTEM.
1.14 Subdivision 1. Definitions. For purposes of this section, the terms defined in this
1.15subdivision have the meanings given.
1.16 (a) "Board" means the Minnesota State Board of Pharmacy established under
1.18 (b) "Controlled substances" means those substances listed in section 152.02,
1.19subdivisions 3 and 4, and those substances defined by the board pursuant to section
1.20152.02, subdivisions 8 and 12.
1.21 (c) "Dispense" or "dispensing" has the meaning given in section 151.01, subdivision
1.2230. Dispensing does not include the direct administering of a controlled substance to a
1.23patient by a licensed health care professional.
1.24 (d) "Dispenser" means a person authorized by law to dispense a controlled substance,
1.25pursuant to a valid prescription. A dispenser does not include a licensed hospital pharmacy
1.26that distributes controlled substances for inpatient hospital care.
2.1 (e) "Prescriber" means a licensed health care professional who is authorized to
2.2prescribe a controlled substance under section 152.12, subdivision 1.
2.3 (f) "Prescription" has the meaning given in section 151.01, subdivision 16.
2.4 Subd. 2. Prescription electronic reporting system. (a) By January 1, 2009, the
2.5board shall establish an electronic system for reporting the information required under
2.6subdivision 4 for all controlled substances dispensed within the state. Data for controlled
2.7substance prescriptions that are dispensed in a quantity small enough to provide treatment
2.8to a patient for a period of 48 hours or less need not be reported.
2.9 (b) The board may contract with a vendor for the purpose of obtaining technical
2.10assistance in the design, implementation, and maintenance of the electronic reporting
2.11system. The vendor's role shall be limited to providing technical support to the board
2.12concerning the software, databases, and computer systems required to interface with the
2.13existing systems currently used by pharmacies to dispense prescriptions and transmit
2.14prescription data to other third parties.
2.15 (c) The board may issue a waiver to a dispenser that is unable to submit dispensing
2.16information by electronic means. The waiver may permit the dispenser to submit
2.17dispensing information by paper form or other means, provided all information required
2.18by subdivision 4 is submitted in this alternative format.
2.19 Subd. 3. Prescription Electronic Reporting Advisory Committee. (a) The
2.20board shall convene an advisory committee. The committee must include at least one
2.22 (1) the Department of Health;
2.23 (2) the Department of Human Services;
2.24 (3) each health-related licensing board that licenses prescribers;
2.25 (4) a professional medical association, which may include an association of pain
2.26management and chemical dependency specialists;
2.27 (5) a professional pharmacy association;
2.28 (6) a consumer privacy or security advocate; and
2.29 (7) a consumer or patient rights organization.
2.30 (b) The advisory committee shall advise the board on the development and operation
2.31of the electronic reporting system, including, but not limited to:
2.32 (1) technical standards for electronic prescription drug reporting;
2.33 (2) proper analysis and interpretation of prescription monitoring data; and
2.34 (3) an evaluation process for the program.
3.1 Subd. 4. Reporting requirements and notice. (a) Each dispenser must submit the
3.2following data to the board or its designated vendor, subject to the notice required under
3.4 (1) prescriber DEA number;
3.5 (2) dispenser DEA number;
3.6 (3) name of the patient for whom the prescription was written;
3.7 (4) date of birth of the patient for whom the prescription was written;
3.8 (5) date the prescription was written;
3.9 (6) date the prescription was filled;
3.10 (7) NDC code for drug dispensed; and
3.11 (8) quantity of controlled substance dispensed.
3.12 (b) The dispenser must submit the required information according to the format and
3.13protocols specified in the "ASAP Telecommunications Format for Controlled Substances,"
3.14May 1995 edition, published by the American Society for Automation in Pharmacy, which
3.15is hereby adopted by reference, by a procedure established by the board.
3.16 (c) A dispenser is not required to submit this data for those controlled substance
3.17prescriptions dispensed for:
3.18 (1) individuals residing in licensed skilled nursing or intermediate care facilities;
3.19 (2) individuals receiving assisted living services under chapter 144G or through a
3.20medical assistance home and community-based waiver;
3.21 (3) individuals receiving medication intravenously;
3.22 (4) individuals receiving hospice and other palliative or end-of-life care; and
3.23 (5) individuals receiving services from a home care provider regulated under chapter
3.25 (d) A dispenser must not submit data under this subdivision unless a conspicuous
3.26notice of the reporting requirements of this section is given to the patient for whom the
3.27prescription was written.
3.28 Subd. 5. Use of data by board. (a) The board shall develop and maintain a database
3.29of the data reported under subdivision 4. The board shall maintain data that could identify
3.30an individual prescriber or dispenser in encrypted form. The database may be used by
3.31permissible users identified under subdivision 6 for the identification of:
3.32 (1) individuals receiving prescriptions for controlled substances from prescribers
3.33who subsequently obtain controlled substances from dispensers in quantities or with a
3.34frequency inconsistent with generally recognized standards of dosage for those controlled
4.1 (2) individuals presenting forged or otherwise false or altered prescriptions for
4.2controlled substances to dispensers.
4.3 (b) No permissible user identified under subdivision 6 may access the database
4.4for the sole purpose of identifying prescribers of controlled substances for unusual or
4.5excessive prescribing patterns without a valid search warrant or court order.
4.6 (c) No personnel of a state or federal occupational licensing board or agency may
4.7access the database for the purpose of obtaining information to be used to initiate or
4.8substantiate a disciplinary action against a prescriber.
4.9 (d) Data reported under subdivision 4 shall be retained by the board in the database
4.10for a six-month period, and shall be removed from the database six months from the
4.11date the data was received.
4.12 Subd. 6. Access to reporting system data. (a) Except as indicated in this
4.13subdivision, the data submitted to the board under subdivision 4 is private data on
4.14individuals as defined in section 13.02, subdivision 12, and not subject to public disclosure.
4.15 (b) Except as specified in subdivision 5, the following persons shall be considered
4.16permissible users and may access the data submitted under subdivision 4 in the same or
4.17similar manner, and for the same or similar purposes, as those persons who are authorized
4.18to access similar private data on individuals under federal and state law:
4.19 (1) a prescriber, to the extent the information relates specifically to a current patient
4.20of the prescriber, to whom the practitioner is prescribing or considering prescribing any
4.22 (2) a dispenser to the extent the information relates specifically to a current patient to
4.23whom that dispenser is dispensing or considering dispensing any controlled substance;
4.24 (3) an individual who is the recipient of a controlled substance prescription for
4.25which data was submitted under subdivision 4;
4.26 (4) personnel of the board specifically assigned to conduct a bona fide investigation
4.27of a specific board licensee;
4.28 (5) personnel of the board engaged in the collection of controlled substance
4.29prescription information as part of the assigned duties and responsibilities under this
4.31 (6) authorized personnel of a vendor under contract with the board who are engaged
4.32in the design, implementation, and maintenance of the electronic reporting system as part
4.33of the assigned duties and responsibilities of their employment, provided that access to data
4.34is limited to the minimum amount necessary to test and maintain the system databases;
4.35 (7) federal, state, and local law enforcement authorities engaged in a bona fide
4.36investigation of a specific person; and
5.1 (8) personnel of the medical assistance program assigned to use the data collected
5.2under this section to identify recipients whose usage of controlled substances may warrant
5.3restriction to a single primary care physician, a single outpatient pharmacy, or a single
5.5 (c) Any permissible user identified in paragraph (b), who directly accesses
5.6the data electronically, shall implement and maintain a comprehensive information
5.7security program that contains administrative, technical, and physical safeguards that
5.8are appropriate to the user's size and complexity, and the sensitivity of the personal
5.9information obtained. The permissible user shall identify reasonably foreseeable internal
5.10and external risks to the security, confidentiality, and integrity of personal information
5.11that could result in the unauthorized disclosure, misuse, or other compromise of the
5.12information and assess the sufficiency of any safeguards in place to control the risks.
5.13 (d) The board shall not release data submitted under this section unless it is provided
5.14with evidence, satisfactory to the board, that the person requesting the information is
5.15entitled to receive the data. Access to the data by law enforcement authorities must be
5.16accompanied by a valid search warrant.
5.17 (e) The board shall not release the name of a prescriber without the written consent
5.18of the prescriber or a valid search warrant or court order. The board shall provide a
5.19mechanism for a prescriber to submit to the board a signed consent authorizing the release
5.20of the prescriber's name when data containing the prescriber's name is requested.
5.21 (f) The board shall maintain a log of all persons who access the data and shall ensure
5.22that any permissible user complies with paragraph (c) prior to attaining direct access to
5.24 Subd. 7. Disciplinary action. (a) A dispenser who knowingly fails to submit data to
5.25the board as required under this section is subject to disciplinary action by the appropriate
5.26health-related licensing board.
5.27 (b) A prescriber or dispenser authorized to access the data who knowingly discloses
5.28the data in violation of state or federal laws relating to the privacy of health care data
5.29shall be subject to disciplinary action by the appropriate health-related licensing board,
5.30and appropriate civil penalties.
5.31 Subd. 8. Evaluation and reporting. (a) The board shall evaluate the prescription
5.32electronic reporting system to determine if the system is cost-effective and whether it is
5.33negatively impacting appropriate prescribing practices of controlled substances. The
5.34board may contract with a vendor to design and conduct the evaluation.
5.35 (b) The board shall submit the evaluation of the system to the legislature by January
6.1 Subd. 9. Immunity from liability; no requirement to obtain information. (a) A
6.2pharmacist, prescriber, or other dispenser making a report to the program in good faith
6.3under this section is immune from any civil, criminal, or administrative liability, which
6.4might otherwise be incurred or imposed as a result of the report, or on the basis that the
6.5pharmacist or prescriber did or did not seek or obtain or use information from the program.
6.6 (b) Nothing in this section shall require a pharmacist, prescriber, or other dispenser
6.7to obtain information about a patient from the program, and the pharmacist, prescriber
6.8or other dispenser, if acting in good faith, is immune from any civil, criminal, or
6.9administrative liability that might otherwise be incurred or imposed for requesting,
6.10receiving, or using information from the program.
6.11EFFECTIVE DATE.This section is effective July 1, 2007, or upon receiving
6.12sufficient nonstate funds to implement the prescription electronic reporting program,
6.13whichever is later. In the event that nonstate funds are not secured by the Board of
6.14Pharmacy to adequately fund the implementation of the prescription electronic reporting
6.15program, the board is not required to implement this section without a subsequent
6.16appropriation from the legislature.
Page 179, after line 9, insert:
"Sec. 25. [256B.0636] PRESCRIBING OF CONTROLLED SUBSTANCES;
6.20 The commissioner shall develop and implement a plan to:
6.21 (1) monitor the prescribing of controlled substances listed in section 152.02,
6.22subdivisions 3 and 4, and those substances defined by the board of pharmacy under section
6.23152.02, subdivisions 8 and 12, by enrolled providers and providers under contract with
6.24participating managed care plans;
6.25 (2) require enrolled providers and providers under contract with participating
6.26managed care plans to report information related to potential patient abuse of the
6.27controlled substances to the commissioner, and the board of pharmacy; and
6.28 (3) provide education to Minnesota health care program enrollees on the proper use
6.29of controlled substances.
Page 208, after line 8, insert:
"Sec. 55. FEDERAL GRANTS.
6.32 The Board of Pharmacy shall apply for any applicable federal grants or other nonstate
6.33funds to establish and fully implement the prescription electronic reporting system.
6.34EFFECTIVE DATE.This section is effective the day following final enactment.
Sec. 56. BOARD OF PHARMACY.
7.2 The Board of Pharmacy shall not increase the license fees of pharmacists or
7.3pharmacies in order to adequately fund the prescription electronic reporting system under
7.4Minnesota Statutes, section 152.126, without specific authority from the legislature.
7.5EFFECTIVE DATE.This section is effective the day following final enactment.
Sec. 57. BOARD OF MEDICAL PRACTICE.
7.7 The board of medical practice shall convene a work group to discuss the appropriate
7.8prescribing of controlled substances listed in Minnesota Statutes, section 152.02,
7.9subdivisions 3 and 4, and those substances defined by the Board of Pharmacy under
7.10Minnesota Statutes, section 152.02, subdivisions 7, 8, and 12, for pain management, and
7.11shall report to the legislature by December 15, 2007.
Renumber the sections in sequence and correct the internal references
Amend the title accordingly