Minnesota Legislature
SF 714
2nd Engrossment - 85th Legislature (2007 - 2008) Posted on 12/15/2009 12:00am
Current Version - 2nd Engrossment
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A bill for an act
relating to health; establishing a controlled substances prescription electronic
reporting system; amending Minnesota Statutes 2006, section 13.381, by adding
a subdivision; proposing coding for new law in Minnesota Statutes, chapter 152.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
Section 1.
Minnesota Statutes 2006, section 13.381, is amended by adding a
subdivision to read:
new text begin Subd. 16a. new text end
new text begin Prescription electronic reporting system. new text end
new text begin
Access to data in the
prescription electronic reporting system is governed by section 152.126.
new text end
Sec. 2.
new text begin
[152.126] 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 7, 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, pursuant to a valid
prescription, a controlled substance. 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) The board shall establish
by January 1, 2009, an electronic system for reporting the information required under
subdivision 3 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 Subd. 3. new text end
new text begin Reporting requirements; 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
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(1) name of the prescriber;
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(2) national provider identifier of the prescriber;
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new text begin
(3) name of the dispenser;
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(4) national provider identifier of the dispenser;
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(5) name of the patient for whom the prescription was written;
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(6) date of birth of the patient for whom the prescription was written;
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(7) date the prescription was written;
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(8) date the prescription was filled;
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(9) name and strength of the controlled substance;
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(10) quantity of controlled substance prescribed; and
new text end
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(11) quantity of controlled substance dispensed.
new text end
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(b) The dispenser must submit the required information by a procedure and in a
format established by the board.
new text end
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(c) A dispenser is not required to submit this data for those controlled substance
prescriptions dispensed for individuals residing in licensed skilled nursing or intermediate
care facilities.
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new text begin
(d) A dispenser must not submit data under this subdivision unless a conspicuous
notice is given to the patient for whom the prescription was written of the reporting
requirements of this section.
new text end
new text begin Subd. 4. 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 3. The database may be used by permissible users
identified under subdivision 5 for the identification of:
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(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
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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 5 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 Subd. 5. 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 3 is private data on
individuals as defined in section 13.02, subdivision 12.
new text end
new text begin
(b) Except as specified in subdivision 4, the following persons shall be considered
permissible users and may access the data submitted under subdivision 3 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;
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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
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(3) an individual who is the recipient of a controlled substance prescription for
which data was submitted under subdivision 3, 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;
new text end
new text begin
(4) personnel of the board specifically assigned to conduct a bona fide investigation
of a specific licensee;
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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 acting pursuant to a valid
search warrant; and
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(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
For purposes of clause (3), access by an individual includes persons in the definition
of an individual under section 13.02.
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
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(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.
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(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. 6. 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 healthcare data shall
be subject to disciplinary action by the appropriate health-related licensing board.
new text end
new text begin Subd. 7. 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
Sec. 3. 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. 4. 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. 5. 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 funding 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 3 and 4 are effective the day following final enactment.
new text end