SF 3201

as introduced - 86th Legislature (2009 - 2010) Posted on 03/10/2010 09:26am

A bill for an act
relating to health; establishing a controlled substances registration; modifying
the controlled substances prescription electronic reporting system; appropriating
money; amending Minnesota Statutes 2008, sections 152.01, by adding
a subdivision; 152.10; 152.11, subdivisions 1, 2, 2a, 2b, 2c, 2d; 152.12,
subdivisions 1, 2, 3; 152.125, subdivisions 2, 3, 4; 152.126, as amended;
repealing Minnesota Statutes 2008, section 152.12, subdivisions 4, 5.

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

Section 1.

Minnesota Statutes 2008, section 152.01, is amended by adding a
subdivision to read:

new text begin Subd. 23. new text end

new text begin Practitioner. new text end

new text begin "Practitioner" has the meaning given in section 151.01,
subdivision 23.
new text end

Sec. 2.

Minnesota Statutes 2008, section 152.10, is amended to read:

152.10 deleted text begin SALES, PERSONS ELIGIBLE deleted text end new text begin CONTROLLED SUBSTANCE
REGISTRATION new text end .

new text begin Subdivision 1. new text end

new text begin Registration requirement. new text end

deleted text begin No person other than a licensed
pharmacist, assistant pharmacist or pharmacist intern under the supervision of a pharmacist
shall sell a stimulant or depressant drug and then only as provided in sections 152.021 to
152.12 and 152.0262. deleted text end new text begin (a) Every person who:
new text end

new text begin (1) manufactures, distributes, prescribes, or dispenses any controlled substance
within the state;
new text end

new text begin (2) proposes to engage in the manufacture, distribution, prescription, or dispensing
of any controlled substance within the state;
new text end

new text begin (3) dispenses or distributes or proposes to dispense or distribute any controlled
substance for use in the state by shipping, mailing, or otherwise delivering the controlled
substance from a location outside the state; or
new text end

new text begin (4) uses or proposes to use controlled substances in the course of a bona fide
research project;
new text end

new text begin shall obtain a registration issued by the Board of Pharmacy.
new text end

new text begin (b) Persons registered by the Board of Pharmacy under this section to manufacture,
distribute, prescribe, dispense, store, or conduct research with controlled substances may
possess, manufacture, distribute, prescribe, dispense, store, or conduct research with those
substances to the extent authorized by their registration and in conformity with this section.
new text end

new text begin (c) Except as otherwise provided by law, the following persons and entities shall not
be required to register under this section and may lawfully possess controlled substances
under this chapter:
new text end

new text begin (1) an agent or employee of any registered manufacturer, registered drug wholesaler,
or registered pharmacy while acting in the course of employment only;
new text end

new text begin (2) a common carrier or an employee whose possession of any controlled substance
is in the usual course of the person's business or employment;
new text end

new text begin (3) a licensed hospital or other licensed institutions wherein sick and injured persons
or animals are cared for or treated or their employees who are working in the course of
employment;
new text end

new text begin (4) a licensed or registered health care professional who acts as the authorized
agent of a practitioner and who administers controlled substances at the direction of the
practitioner, provided that the practitioner is authorized to prescribe controlled substances
under section 152.12;
new text end

new text begin (5) an analytical laboratory or employee acting within the course of employment,
when conducting an anonymous analysis service when such laboratory is registered by the
federal Drug Enforcement Administration;
new text end

new text begin (6) a person in possession of any controlled substance prescribed for that person
under section 152.12, subdivision 1; or
new text end

new text begin (7) the owner of an animal for which a controlled substance has been prescribed
under section 152.12, subdivision 2.
new text end

new text begin Nothing in this section shall prohibit a person, for whom a controlled substance has been
dispensed in accordance with a prescription issued under section 152.12, from designating
a family member, caregiver, or other individual to handle the controlled substance for the
purpose of assisting the person in obtaining or administering the controlled substance.
new text end

new text begin (d) A separate registration shall be required at each principal place of business
or professional practice where the applicant manufactures, distributes, prescribes, or
dispenses controlled substances, except an office used by a practitioner who is registered
at another location where controlled substances are prescribed but neither administered
nor otherwise dispensed as a regular part of the professional practice of the practitioner at
the practitioner's office, and where no supplies of controlled substances are maintained.
new text end

new text begin (e) The Board of Pharmacy may inspect the establishment of a registrant or applicant
for registration according to the board's rule.
new text end

new text begin (f) The board may require a registrant to submit documents or written statements
of fact relevant to a registration that the board deems necessary to determine whether
the registration should be granted or denied. The failure of the registrant to provide the
documents or statements within a reasonable time after being requested to do so shall be
deemed to be a waiver by the registrant of the opportunity to present the documents or
statements for consideration by the board in granting or denying the registration.
new text end

new text begin (g) The failure to renew the controlled substance registration on a timely basis shall
cause the registration to be automatically forfeited.
new text end

new text begin Subd. 2. new text end

new text begin Registration. new text end

new text begin (a) The Board of Pharmacy shall register an applicant to
manufacture, dispense, prescribe, or distribute controlled substances included in section
152.02, subdivisions 3 to 6, unless it determines that the issuance of that registration
would be inconsistent with the public interest. In determining the public interest, the
board shall consider the following factors:
new text end

new text begin (1) maintenance of effective controls against diversion of controlled substances into
other than legitimate medical, scientific, or industrial channels;
new text end

new text begin (2) compliance with applicable federal, state, and local law;
new text end

new text begin (3) any convictions of the applicant under any federal or state laws relating to any
controlled substance;
new text end

new text begin (4) past experience in the manufacture or distribution of controlled substances, and
the existence in the applicant's establishment of effective controls against diversion;
new text end

new text begin (5) furnishing by the applicant of false or fraudulent material in any application
filed under this chapter;
new text end

new text begin (6) suspension or revocation of the applicant's federal registration to manufacture,
distribute, prescribe, or dispense controlled substances as authorized by federal law; and
new text end

new text begin (7) any other factor relevant to and consistent with the public health and safety.
new text end

new text begin (b) Registration under paragraph (a) does not entitle a registrant to manufacture,
dispense, prescribe, and distribute controlled substances included in section 152.02,
subdivision 2. Manufacturing, dispensing, prescribing, and distribution of controlled
substances included in section 151.02, subdivision 2, may only occur as part of a bona
fide research project under section 152.12, subdivision 3, and as allowed under federal
law and regulations.
new text end

new text begin (c) Practitioners must be registered under this section in order to dispense or to
prescribe any controlled substances included in section 152.02, subdivisions 3 to 6.
new text end

new text begin Subd. 3. new text end

new text begin Revocation and suspension of registration. new text end

new text begin (a) A registration under this
section to manufacture, dispense, prescribe, or distribute a controlled substance may be
suspended or revoked by the Board of Pharmacy upon a finding that the registrant:
new text end

new text begin (1) has furnished false or fraudulent material information in any application filed
under this section;
new text end

new text begin (2) has been convicted of a felony pursuant to any state or federal law relating to
any controlled substance;
new text end

new text begin (3) has had the registrant's federal controlled substance registration suspended or
revoked to manufacture, distribute, prescribe, or dispense controlled substances;
new text end

new text begin (4) has had the registrant's state license to practice the registrant's profession
suspended or revoked by the applicable governing health licensing board; or
new text end

new text begin (5) has had the registrant's state license to practice the registrant's profession placed
on conditional status by the applicable health licensing board when the conditions prohibit
the registrant from prescribing, administering, or dispensing controlled substances.
new text end

new text begin (b) The Board of Pharmacy may limit revocation or suspension of a registration
to the particular controlled substance with respect to which grounds for revocation or
suspension exist.
new text end

Sec. 3.

Minnesota Statutes 2008, section 152.11, subdivision 1, is amended to read:

Subdivision 1.

Written prescription requirement for Schedule II controlled
substances.

No person may dispense a controlled substance included in Schedule II
of section 152.02 without a prescription written by a doctor of medicine, a doctor of
osteopathy licensed to practice medicine, a doctor of dental surgery, a doctor of dental
medicine, a doctor of podiatry, or a doctor of veterinary medicine, lawfully licensed to
prescribe in this state new text begin and registered under section 152.10 new text end or by a practitioner licensed
to prescribe controlled substances by the state in which the prescription is issued, and
having a current federal Drug Enforcement Administration registration number. Provided
that in emergency situations, as authorized by federal law, such drug may be dispensed
upon oral prescription reduced promptly to writing and filed by the pharmacist. Such
prescriptions shall be retained in conformity with section 152.101. No prescription for
a Schedule II substance may be refilled.

For the purposes of this chapter, a written prescription or oral prescription, which
shall be reduced to writing, for a controlled substance in Schedule II, III, IV or V is void
unless (1) it is written in ink and contains the name and address of the person for whose
use it is intended; (2) it states the amount of the controlled substance to be compounded or
dispensed, with directions for its use; (3) if a written prescription, it contains the signature,
address and federal deleted text begin registry number deleted text end new text begin and state controlled substance registration numbers new text end of
the prescriber and a designation of the branch of the healing art pursued by the prescriber;
and if an oral prescription, the name and address of the prescriber and a designation
of the prescriber's branch of the healing art; and (4) it shows the date when signed by
the prescriber, or the date of acceptance in the pharmacy if an oral prescription. Every
licensed pharmacist who compounds any such prescription shall retain such prescription
in a file for a period of not less than two years, open to inspection by any officer of
the state, county, or municipal government, whose duty it is to aid and assist with the
enforcement of this chapter. Every such pharmacist shall distinctly label the container
with the directions contained in the prescription for the use thereof.

Sec. 4.

Minnesota Statutes 2008, section 152.11, subdivision 2, is amended to read:

Subd. 2.

Written or oral prescription requirement for Schedule III deleted text begin or deleted text end new text begin , new text end IV new text begin , or
V new text end controlled substances.

No person may dispense a controlled substance included in
Schedule III or IV of section 152.02 new text begin or a controlled substance included Schedule V of
section 152.02 that is also a legend drug, new text end without a written or oral prescription from
a doctor of medicine, a doctor of osteopathy licensed to practice medicine, a doctor of
dental surgery, a doctor of dental medicine, a doctor of podiatry, a doctor of optometry
limited to Schedule IV, or a doctor of veterinary medicine, lawfully licensed to prescribe
in this state or from a practitioner licensed to prescribe controlled substances by the
state in which the prescription is issued, and having a current federal drug enforcement
administration registration number. Such prescription may not be dispensed or refilled
except with the written or verbal consent of the prescriber, and in no event more than six
months after the date on which such prescription was issued and no such prescription may
be refilled more than five times.

Sec. 5.

Minnesota Statutes 2008, section 152.11, subdivision 2a, is amended to read:

Subd. 2a.

Federal new text begin and state new text end registration number exemption.

A prescription
need not bear a federal drug enforcement administration new text begin or state controlled substance
new text end registration number that authorizes the prescriber to prescribe controlled substances if the
drug prescribed is not a controlled substance in schedule II, III, IV, or V. No person shall
impose a requirement inconsistent with this subdivision.

Sec. 6.

Minnesota Statutes 2008, section 152.11, subdivision 2b, is amended to read:

Subd. 2b.

Restriction on release of federal new text begin and state new text end registration deleted text begin number deleted text end new text begin
numbers new text end .

No person or entity may offer for sale, sell, lease, or otherwise release a federal
drug enforcement administration registration number new text begin or a registration number issued
under section 152.10 new text end for any reason, except for drug enforcement purposes authorized
by this chapter and the federal controlled substances registration system. For purposes
of this section, an entity includes a state governmental agency or regulatory board, a
health plan company as defined under section 62Q.01, subdivision 4, a managed care
organization as defined under section 62Q.01, subdivision 5, or any other entity that
maintains prescription data.

Sec. 7.

Minnesota Statutes 2008, section 152.11, subdivision 2c, is amended to read:

Subd. 2c.

Restriction on use of federal new text begin and state new text end registration deleted text begin number deleted text end new text begin numbers new text end .

No entity may use a federal drug enforcement administration registration number new text begin or
a registration number issued under section 152.10 new text end to identify or monitor the prescribing
practices of a prescriber to whom that number has been assigned, except for drug
enforcement purposes authorized by this chapter and the federal controlled substances
registration system. For purposes of this section, an entity includes a health plan company
as defined under section 62Q.01, subdivision 4, a managed care organization as defined
under section 62Q.01, subdivision 5, or any other entity that maintains prescription data.

Sec. 8.

Minnesota Statutes 2008, section 152.11, subdivision 2d, is amended to read:

Subd. 2d.

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

deleted text begin (a) deleted text end No person may dispense a controlled substance deleted text begin included in
schedule II or III deleted text end new text begin prescription that is required to be reported to the controlled substance
prescription electronic reporting system established under section 152.126, new text end 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.

deleted text begin (b) This subdivision applies only to purchases of controlled substances that are not
covered, in whole or in part, by a health plan company or other third-party payor. The
Board of Pharmacy shall report to the legislature by July 1, 2009, on the effect of this
subdivision. The board shall include in the report the incidence of complaints, if any,
generated by the requirements of this subdivision and whether this subdivision is creating
barriers to pharmaceutical access.
deleted text end

Sec. 9.

Minnesota Statutes 2008, section 152.12, subdivision 1, is amended to read:

Subdivision 1.

Prescribing, dispensing, administering controlled substances in
schedules II through V.

A licensed doctor of medicine, a doctor of osteopathy, duly
licensed to practice medicine, a doctor of dental surgery, a doctor of dental medicine, a
licensed doctor of podiatry, or a licensed doctor of optometry limited to schedules IV
and V, and in the course of professional practice only, may prescribe, administer, and
dispense a controlled substance included in Schedules II through V of section 152.02, may
cause the same to be administered by a nurse, an intern or an assistant under the direction
and supervision of the doctor, and may cause a person who is an appropriately certified
and licensed health care professional to prescribe and administer the same within the
expressed legal scope of the person's practice as defined in Minnesota Statutes. new text begin Any
person authorized to prescribe or dispense controlled substances under this subdivision
must also be registered under section 152.10. new text end

Sec. 10.

Minnesota Statutes 2008, section 152.12, subdivision 2, is amended to read:

Subd. 2.

Doctor of veterinary medicine.

A licensed doctor of veterinary medicine,
in good faith, and in the course of professional practice only, and not for use by a human
being, may prescribe, administer, and dispense a controlled substance included in
schedules II through V of section 152.02, and may cause the same to be administered by
an assistant under the direction and supervision of the doctor. new text begin Any person authorized to
prescribe or dispense controlled substances under this subdivision must also be registered
under section 152.10. new text end

Sec. 11.

Minnesota Statutes 2008, section 152.12, subdivision 3, is amended to read:

Subd. 3.

Research project use of controlled substances.

Any qualified person
may use controlled substances in the course of a bona fide research project but cannot
administer or dispense such drugs to human beings unless such drugs are prescribed,
dispensed and administered by a person lawfully authorized to do so. Every person
who engages in research involving the use of such substances deleted text begin shall apply annually
for registration by deleted text end new text begin must register with new text end the state Board of Pharmacy deleted text begin provided that such
registration shall not be required if the person is covered by and has complied with federal
laws covering such research projects deleted text end new text begin under section 152.10 new text end .

Sec. 12.

Minnesota Statutes 2008, section 152.125, subdivision 2, is amended to read:

Subd. 2.

Prescription and administration of controlled substances for
intractable pain.

Notwithstanding any other provision of this chapter, a deleted text begin physician deleted text end
new text begin practitioner lawfully licensed to prescribe controlled substances in the state and registered
under section 152.10 new text end may prescribe or administer a controlled substance in schedules
II to V of section 152.02 to an individual in the course of the deleted text begin physician's deleted text end new text begin practitioner's
new text end treatment of the individual for a diagnosed condition causing intractable pain. No
deleted text begin physician deleted text end new text begin practitioner new text end shall be subject to disciplinary action by deleted text begin the Board of Medical
Practice deleted text end new text begin a health licensing board new text end for appropriately prescribing or administering a
controlled substance in schedules II to V of section 152.02 in the course of treatment of an
individual for intractable pain, provided the deleted text begin physician deleted text end new text begin practitioner new text end keeps accurate records
of the purpose, use, prescription, and disposal of controlled substances, writes accurate
prescriptions, and prescribes medications in conformance with new text begin the new text end chapter deleted text begin 147 deleted text end new text begin of law
under which the practitioner is licensed new text end .

Sec. 13.

Minnesota Statutes 2008, section 152.125, subdivision 3, is amended to read:

Subd. 3.

Limits on applicability.

This section does not apply to:

(1) a deleted text begin physician's deleted text end new text begin practitioner's new text end treatment of an individual for chemical dependency
resulting from the use of controlled substances in schedules II to V of section 152.02;

(2) the prescription or administration of controlled substances in schedules II to V of
section 152.02 to an individual whom the deleted text begin physician deleted text end new text begin practitioner new text end knows to be using the
controlled substances for nontherapeutic purposes;

(3) the prescription or administration of controlled substances in schedules II to V of
section 152.02 for the purpose of terminating the life of an individual having intractable
pain; or

(4) the prescription or administration of a controlled substance in schedules II to V
of section 152.02 that is not a controlled substance approved by the United States Food
and Drug Administration for pain relief.

Sec. 14.

Minnesota Statutes 2008, section 152.125, subdivision 4, is amended to read:

Subd. 4.

Notice of risks.

Prior to treating an individual for intractable pain in
accordance with subdivision 2, a deleted text begin physician deleted text end new text begin practitioner new text end shall discuss with the individual
the risks associated with the controlled substances in schedules II to V of section 152.02 to
be prescribed or administered in the course of the deleted text begin physician's deleted text end new text begin practitioner's new text end treatment of an
individual, and document the discussion in the individual's record.

Sec. 15.

Minnesota Statutes 2008, section 152.126, as amended by Laws 2009, chapter
79, article 11, sections 9, 10, and 11, is amended to read:

152.126 deleted text begin SCHEDULE II AND III deleted text end 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 to 5, 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. For the purposes of this section, a dispenser does not
include a licensed hospital pharmacy that distributes controlled substances for inpatient
hospital care or a veterinarian who is dispensing prescriptions under section 156.18.

(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. 1a.

Treatment of intractable pain.

This section is not intended to limit or
interfere with the legitimate prescribing of controlled substances for pain. No prescriber
shall be subject to disciplinary action by a health-related licensing board for prescribing a
controlled substance according to the provisions of section 152.125.

Subd. 2.

Prescription electronic reporting system.

(a) The board shall establish
by January 1, 2010, an electronic system for reporting the information required under
subdivision 4 for all controlled substances dispensed within the state.

(b) The board may contract with a vendor for the purpose of obtaining technical
assistance in the design, implementation, operation, and maintenance of the electronic
reporting system.

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 professional nursing association;

(7) a professional dental association;

(8) a consumer privacy or security advocate; and

(9) 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.

deleted text begin (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.
deleted text end

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) prescription number;

(6) name of the patient for whom the prescription was written;

(7) address of the patient for whom the prescription was written;

(8) date of birth of the patient for whom the prescription was written;

(9) date the prescription was written;

(10) date the prescription was filled;

(11) name and strength of the controlled substance;

(12) quantity of controlled substance prescribed;

(13) quantity of controlled substance dispensed; and

(14) number of days supply.

(b) The dispenser must submit the required information by a procedure and in a
format established by the board. The board may allow dispensers to omit data listed in this
subdivision or may require the submission of data not listed in this subdivision provided
the omission or submission is necessary for the purpose of complying with the electronic
reporting or data transmission standards of the American Society for Automation in
Pharmacy, the National Council on Prescription Drug Programs, or other relevant national
standard-setting body.

(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 generally recognized standards of use for those controlled
substances, including standards accepted by national and international pain management
associations; 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 new text begin no later than new text end 12 months
from deleted text begin the date deleted text end new text begin the last day of the month during which new text end 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 new text begin or an agent or employee of the prescriber to whom the prescriber has
delegated the task of accessing the data new text end , to the extent the information relates specifically to
a current patient, to whom the prescriber is prescribing or considering prescribing any
controlled substance new text begin and with the provision that the prescriber remains responsible for the
use or misuse of data accessed by a delegated agent or employee new text end ;

(2) a dispenser new text begin or an agent or employee of the dispenser to whom the dispenser has
delegated the task of accessing the data new text end , 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 begin and with the provision that the dispenser remains responsible for the
use or misuse of data accessed by a delegated agent or employee new text end ;

(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, operation, 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 carry out such duties
and responsibilities;

(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.

(g) Section 13.05, subdivision 6, shall apply to any contract the board enters into
pursuant to subdivision 2. A vendor shall not use data collected under this section for
any purpose not specified in this section.

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 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 deleted text begin January deleted text end
new text begin July new text end 15, 2011.

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.

Sec. 16. new text begin CONTROLLED SUBSTANCE REGISTRATION FUND ESTABLISHED
AND APPROPRIATIONS MADE.
new text end

new text begin (a) The controlled substance account is created in the state government special
revenue fund. All fees collected under Minnesota Statutes, section 152.10, shall be
deposited into the account.
new text end

new text begin (b) Money in the account is appropriated to the Board of Pharmacy for the purpose
of:
new text end

new text begin (1) administering the controlled substance prescription electronic reporting system
established under Minnesota Statutes, section 152.126; and
new text end

new text begin (2) administering and enforcing the registration provisions of Minnesota Statutes,
section 152.10.
new text end

new text begin (c) Money in the account is appropriated to the commissioner of human services for
the purpose of chemical dependency treatment.
new text end

Sec. 17. new text begin REPEALER.
new text end

new text begin Minnesota Statutes 2008, section 152.12, subdivisions 4 and 5, new text end new text begin are repealed.
new text end