HF 1041

2nd Engrossment - 85th Legislature (2007 - 2008) Posted on 12/15/2009 12:00am

A bill for an act
relating to health; establishing a controlled substances prescription electronic
reporting system; requiring an evaluation report; amending Minnesota Statutes
2006, section 152.11, by adding a subdivision; proposing coding for new law in
Minnesota Statutes, chapters 152; 256B.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2006, section 152.11, is amended by adding a
subdivision to read:

new text begin Subd. 2d. new text end

new text begin Identification requirement for schedule II or III controlled substance.
new text end

new text begin No person may dispense a controlled substance included in schedule II or III without
requiring the person purchasing the controlled substance, who need not be the person for
whom the controlled substance prescription is written, to present valid photographic
identification, unless the person purchasing the controlled substance, or if applicable the
person for whom the controlled substance prescription is written, is known to the dispenser.
new text end

Sec. 2.

new text begin [152.126] SCHEDULE II AND III CONTROLLED SUBSTANCES
PRESCRIPTION ELECTRONIC REPORTING SYSTEM.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin For purposes of this section, the terms defined in this
subdivision have the meanings given.
new text end

new text begin (a) "Board" means the Minnesota State Board of Pharmacy established under
chapter 151.
new text end

new text begin (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 8 and 12.
new text end

new text begin (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.
new text end

new text begin (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.
new text end

new text begin (e) "Prescriber" means a licensed health care professional who is authorized to
prescribe a controlled substance under section 152.12, subdivision 1.
new text end

new text begin (f) "Prescription" has the meaning given in section 151.01, subdivision 16.
new text end

new text begin Subd. 2. new text end

new text begin Prescription electronic reporting system. new text end

new text begin (a) By January 1, 2009, the
board shall establish 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.
new text end

new text begin (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.
new text end

new text begin (c) The board may issue a waiver to a dispenser that is unable to submit dispensing
information by electronic means. The waiver may permit the dispenser to submit
dispensing information by paper form or other means, provided all information required
by subdivision 4 is submitted in this alternative format.
new text end

new text begin Subd. 3. new text end

new text begin Prescription Electronic Reporting Advisory Committee. new text end

new text begin (a) The
board shall convene an advisory committee. The committee must include at least one
representative of:
new text end

new text begin (1) the Department of Health;
new text end

new text begin (2) the Department of Human Services;
new text end

new text begin (3) each health-related licensing board that licenses prescribers;
new text end

new text begin (4) a professional medical association, which may include an association of pain
management and chemical dependency specialists;
new text end

new text begin (5) a professional pharmacy association;
new text end

new text begin (6) a consumer privacy or security advocate; and
new text end

new text begin (7) a consumer or patient rights organization.
new text end

new text begin (b) The advisory committee shall advise the board on the development and operation
of the electronic reporting system, including, but not limited to:
new text end

new text begin (1) technical standards for electronic prescription drug reporting;
new text end

new text begin (2) proper analysis and interpretation of prescription monitoring data; and
new text end

new text begin (3) an evaluation process for the program.
new text end

new text begin Subd. 4. new text end

new text begin Reporting requirements and notice. new text end

new text begin (a) Each dispenser must submit the
following data to the board or its designated vendor, subject to the notice required under
paragraph (d):
new text end

new text begin (1) prescriber DEA number;
new text end

new text begin (2) dispenser DEA number;
new text end

new text begin (3) name of the patient for whom the prescription was written;
new text end

new text begin (4) date of birth of the patient for whom the prescription was written;
new text end

new text begin (5) date the prescription was written;
new text end

new text begin (6) date the prescription was filled;
new text end

new text begin (7) NDC code for drug dispensed; and
new text end

new text begin (8) quantity of controlled substance dispensed.
new text end

new text begin (b) The dispenser must submit the required information according to the format and
protocols specified in the "ASAP Telecommunications Format for Controlled Substances,"
May 1995 edition, published by the American Society for Automation in Pharmacy, which
is hereby adopted by reference, by a procedure established by the board.
new text end

new text begin (c) A dispenser is not required to submit this data for those controlled substance
prescriptions dispensed for:
new text end

new text begin (1) individuals residing in licensed skilled nursing or intermediate care facilities;
new text end

new text begin (2) individuals receiving assisted living services under chapter 144G or through a
medical assistance home and community-based waiver;
new text end

new text begin (3) individuals receiving medication intravenously;
new text end

new text begin (4) individuals receiving hospice and other palliative or end-of-life care; and
new text end

new text begin (5) individuals receiving services from a home care provider regulated under chapter
144A.
new text end

new text begin (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.
new text end

new text begin Subd. 5. new text end

new text begin Use of data by board. new text end

new text begin (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:
new text end

new text begin (1) individuals receiving prescriptions for controlled substances from prescribers
who subsequently obtain controlled substances from dispensers in quantities or with a
frequency inconsistent with generally recognized standards of dosage for those controlled
substances; and
new text end

new text begin (2) individuals presenting forged or otherwise false or altered prescriptions for
controlled substances to dispensers.
new text end

new text begin (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.
new text end

new text begin (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.
new text end

new text begin (d) Data reported under subdivision 4 shall be retained by the board in the database
for a six-month period, and shall be removed from the database six months from the
date the data was received.
new text end

new text begin Subd. 6. new text end

new text begin Access to reporting system data. new text end

new text begin (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.
new text end

new text begin (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:
new text end

new text begin (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;
new text end

new text begin (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;
new text end

new text begin (3) an individual who is the recipient of a controlled substance prescription for
which data was submitted under subdivision 4;
new text end

new text begin (4) personnel of the board specifically assigned to conduct a bona fide investigation
of a specific board licensee;
new text end

new text begin (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;
new text end

new text begin (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;
new text end

new text begin (7) federal, state, and local law enforcement authorities engaged in a bona fide
investigation of a specific person; and
new text end

new text begin (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.
new text end

new text begin (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.
new text end

new text begin (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. Access to the data by law enforcement authorities must be
accompanied by a valid search warrant.
new text end

new text begin (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.
new text end

new text begin (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.
new text end

new text begin Subd. 7. new text end

new text begin Disciplinary action. new text end

new text begin (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.
new text end

new text begin (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.
new text end

new text begin Subd. 8. new text end

new text begin Evaluation and reporting. new text end

new text begin (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.
new text end

new text begin (b) The board shall submit the evaluation of the system to the legislature by January
15, 2010.
new text end

new text begin Subd. 9. new text end

new text begin Immunity from liability; no requirement to obtain information. new text end

new text begin (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.
new text end

new text begin (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.
new text end

Sec. 3.

new text begin [256B.0636] PRESCRIBING OF CONTROLLED SUBSTANCES; ABUSE
PREVENTION.
new text end

new text begin The commissioner shall develop and implement a plan to:
new text end

new text begin (1) monitor the prescribing of controlled substances listed in section 152.02,
subdivisions 3 and 4, and those substances defined by the board of pharmacy under section
152.02, subdivisions 8 and 12, by enrolled providers and providers under contract with
participating managed care plans;
new text end

new text begin (2) require enrolled providers and providers under contract with participating
managed care plans to report information related to potential patient abuse of the
controlled substances to the commissioner, and the board of pharmacy; and
new text end

new text begin (3) provide education to Minnesota health care program enrollees on the proper use
of controlled substances.
new text end

Sec. 4. new text begin FEDERAL GRANTS.
new text end

new text begin The Board of Pharmacy shall apply for any applicable federal grants or other nonstate
funds to establish and fully implement the prescription electronic reporting system.
new text end

Sec. 5. new text begin BOARD OF PHARMACY.
new text end

new text begin The Board of Pharmacy shall not increase the license fees of pharmacists or
pharmacies in order to adequately fund the prescription electronic reporting system under
Minnesota Statutes, section 152.126, without specific authority from the legislature.
new text end

Sec. 6. new text begin BOARD OF MEDICAL PRACTICE.
new text end

new text begin The board of medical practice shall convene a work group to discuss the appropriate
prescribing of controlled substances listed in Minnesota Statutes, section 152.02,
subdivisions 3 and 4, and those substances defined by the Board of Pharmacy under
Minnesota Statutes, section 152.02, subdivisions 7, 8, and 12, for pain management, and
shall report to the legislature by December 15, 2007.
new text end

Sec. 7. new text begin EFFECTIVE DATE.
new text end

new text begin (a) Section 2 is effective July 1, 2007, or upon receiving sufficient nonstate funds to
implement the prescription electronic reporting program, whichever is later. In the event
that nonstate funds are not secured by the Board of Pharmacy to adequately fund the
implementation of the prescription electronic reporting program, the board is not required
to implement section 2 without a subsequent appropriation from the legislature.
new text end

new text begin (b) Sections 4 and 5 are effective the day following final enactment.
new text end