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Minnesota Legislature

Office of the Revisor of Statutes

SF 2941

3rd Engrossment - 85th Legislature (2007 - 2008) Posted on 12/15/2009 12:00am

KEY: stricken = removed, old language.
underscored = added, new language.

Current Version - 3rd Engrossment

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A bill for an act
relating to health; regulating free or discounted chiropractic examinations or
treatments; changing provisions for prescribing and filing drugs; amending
Minnesota Statutes 2006, sections 148.10, by adding a subdivision; 151.01,
subdivision 23; 151.37, subdivision 7; Minnesota Statutes 2007 Supplement,
sections 148.235, subdivision 11; 151.37, subdivision 2; 151.56; 152.126;
repealing Minnesota Statutes 2007 Supplement, section 148.235, subdivision 12.

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

Section 1.

Minnesota Statutes 2006, section 148.10, is amended by adding a
subdivision to read:


new text begin Subd. 1a. new text end

new text begin Free or discounted examination or treatment. new text end

new text begin (a) Free or discounted
examinations must provide sufficient information to allow for a diagnosis and initiation
of treatment, with the exception of examinations clearly identified as for the purpose of
screening. Free or discounted chiropractic treatments shall be comparable to similar
nondiscounted chiropractic treatments.
new text end

new text begin (b) When using the word "free," or any other term with essentially the same meaning
in reference to delivering any service, examination, or treatment, the following statement
must be presented to the patient or guardian for signature and kept on file: "I understand
that one or more services provided have been or will be free of charge. Any subsequent
services provided will be provided at the fees that have been or will be explained to me."
new text end

Sec. 2.

Minnesota Statutes 2007 Supplement, section 148.235, subdivision 11, is
amended to read:


Subd. 11.

Dispensing by protocol.

Subject to the requirements of this subdivision,
a registered nurse in a family planning agency as defined in Minnesota Rules, part
9505.0280, subpart 3, may dispense deleted text beginoraldeleted text end contraceptives prescribed by a licensed
practitioner as defined in section 151.01, subdivision 23, pursuant to a dispensing protocol
established by the agency's medical director or under the direction of a physician. The
dispensing protocol must address the requirements of sections 151.01, subdivision 30,
and 151.212, subdivision 1. In addition, the registered nurse may not dispense deleted text beginoraldeleted text end
contraceptives if the patient is under 12 years of age.

Sec. 3.

Minnesota Statutes 2006, section 151.01, subdivision 23, is amended to read:


Subd. 23.

Practitioner.

"Practitioner" means a licensed doctor of medicine, licensed
doctor of osteopathy duly licensed to practice medicine, licensed doctor of dentistry,
licensed doctor of optometry, licensed podiatrist, or licensed veterinarian. For purposes of
sections 151.15, subdivision 4, 151.37, subdivision 2, deleted text beginparagraphdeleted text end new text beginparagraphs new text end(b), new text begin(e), and
(f),
new text endand 151.461, "practitioner" also means a physician assistant authorized to prescribe,
dispense, and administer under chapter 147A, or an advanced practice nurse authorized to
prescribe, dispense, and administer under section 148.235.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 4.

Minnesota Statutes 2007 Supplement, section 151.37, subdivision 2, is
amended to read:


Subd. 2.

Prescribing and filing.

(a) A licensed practitioner in the course of
professional practice only, may prescribe, administer, and dispense a legend drug, and may
cause the same to be administered by a nurse, a physician assistant, or medical student or
resident under the practitioner's direction and supervision, and may cause a person who
is an appropriately certified, registered, or licensed health care professional to prescribe,
dispense, and administer the same within the expressed legal scope of the person's practice
as defined in Minnesota Statutes. A licensed practitioner may prescribe a legend drug,
without reference to a specific patient, by directing a nurse, pursuant to section 148.235,
subdivisions 8 and 9
, physician assistant, or medical student or resident to adhere to
a particular practice guideline or protocol when treating patients whose condition falls
within such guideline or protocol, and when such guideline or protocol specifies the
circumstances under which the legend drug is to be prescribed and administered. An
individual who verbally, electronically, or otherwise transmits a written, oral, or electronic
order, as an agent of a prescriber, shall not be deemed to have prescribed the legend drug.
This paragraph applies to a physician assistant only if the physician assistant meets the
requirements of section 147A.18.

(b) A licensed practitioner that dispenses for profit a legend drug that is to be
administered orally, is ordinarily dispensed by a pharmacist, and is not a vaccine, must
file with the practitioner's licensing board a statement indicating that the practitioner
dispenses legend drugs for profit, the general circumstances under which the practitioner
dispenses for profit, and the types of legend drugs generally dispensed. It is unlawful to
dispense legend drugs for profit after July 31, 1990, unless the statement has been filed
with the appropriate licensing board. For purposes of this paragraph, "profit" means (1)
any amount received by the practitioner in excess of the acquisition cost of a legend drug
for legend drugs that are purchased in prepackaged form, or (2) any amount received
by the practitioner in excess of the acquisition cost of a legend drug plus the cost of
making the drug available if the legend drug requires compounding, packaging, or other
treatment. The statement filed under this paragraph is public data under section 13.03.
This paragraph does not apply to a licensed doctor of veterinary medicine or a registered
pharmacist. Any person other than a licensed practitioner with the authority to prescribe,
dispense, and administer a legend drug under paragraph (a) shall not dispense for profit.
To dispense for profit does not include dispensing by a community health clinic when the
profit from dispensing is used to meet operating expenses.

(c) A prescription or drug order for deleted text begina legend drugdeleted text end new text beginthe following drugs new text endis not
valid deleted text beginif it is based solely on an online questionnairedeleted text end, unless it can be established that
the prescription or order was based on a documented patient evaluationnew text begin, including an
examination,
new text end adequate to establish a diagnosis and identify underlying conditions and
contraindications to treatmentnew text begin:
new text end

new text begin (1) controlled substance drugs listed in section 152.02, subdivisions 3 to 5;
new text end

new text begin (2) drugs defined by the Board of Pharmacy as controlled substances under section
152.02, subdivisions 7, 8, and 12;
new text end

new text begin (3) muscle relaxants;
new text end

new text begin (4) centrally acting analgesics with opioid activity;
new text end

new text begin (5) drugs containing butalbital; or
new text end

new text begin (6) phoshodiesterase type 5 inhibitors when used to treat erectile dysfunctionnew text end.

new text begin (d) For the purposes of paragraph (c), the requirement for an examination shall be
met if an in-person examination has been completed in any of the following circumstances:
new text end

new text begin (1) the prescribing practitioner examines the patient at the time the prescription
or drug order is issued;
new text end

new text begin (2) the prescribing practitioner has performed a prior examination of the patient;
new text end

new text begin (3) another prescribing practitioner practicing within the same group or clinic as the
prescribing practitioner has examined the patient;
new text end

new text begin (4) a consulting practitioner to whom the prescribing practitioner has referred the
patient has examined the patient; or
new text end

new text begin (5) the referring practitioner has performed an examination in the case of a
consultant practitioner issuing a prescription or drug order when providing services by
means of telemedicine.
new text end

new text begin (e) Nothing in paragraph (c) or (d) prohibits a licensed practitioner from prescribing
a drug through the use of a guideline or protocol pursuant to paragraph (a) of this
subdivision.
new text end

new text begin (f) Nothing in this chapter prohibits a licensed practitioner from issuing a
prescription or dispensing a legend drug in accordance with the Expedited Partner Therapy
in the Management of Sexually Transmitted Diseases guidance document issued by the
United States Centers for Disease Control.
new text end

new text begin (g) Nothing in paragraph (c) or (d) limits prescription, administration, or dispensing
of legend drugs through a public health clinic or other distribution mechanism approved
by the commissioner of health or a board of health in order to prevent, mitigate, or treat
a pandemic illness, infectious disease outbreak, intentional, or accidental release of a
biological, chemical, or radiological agent.
new text end

new text begin (h) No pharmacist employed by, under contract to, or working for a pharmacy
licensed under section 151.19, subdivision 1, may dispense a legend drug based on a
prescription that the pharmacist knows, or would reasonably be expected to know, is not
valid under paragraph (c) of this subdivision.
new text end

new text begin (i) No pharmacist employed by, under contract to, or working for a pharmacy
licensed under section 151.19, subdivision 2, may dispense a legend drug, to a resident
of this state, based on a prescription that the pharmacist knows, or would reasonably be
expected to know, is not valid under paragraph (c) of this subdivision.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 5.

Minnesota Statutes 2006, section 151.37, subdivision 7, is amended to read:


Subd. 7.

Exclusion for prescriptions.

Nothing in this chapter shall prohibit the
possession of a legend drug by a person for that person's use when it has been dispensed
to the person in accordance with a written or oral prescription by a practitioner.new text begin Nothing
in this chapter shall prohibit a person, for whom a legend drug has been dispensed in
accordance with a written or oral prescription by a practitioner, from designating a family
member, caregiver, or other individual to handle the legend drug for the purpose of
assisting the person in obtaining or administering the drug.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 6.

Minnesota Statutes 2007 Supplement, section 151.56, is amended to read:


151.56 COUNTY RETURN OF UNUSED DRUGS OR MEDICAL DEVICES.

Notwithstanding Minnesota Rules, part 6800.2700, pharmacies may accept returns
of deleted text beginunused drugsdeleted text end and new text beginredispense unopened, unused drugs in board-approved unit dose
packaging and
new text endmedical devices from county jails and juvenile correctional facilities. In
order to return unused drugs and medical devices, the county jail or juvenile correctional
facility must have a deleted text begintrained medication techniciandeleted text end new text begincorrectional employee trained in the
delivery and storage of medications
new text endon hand 24 hours a day, seven days a week, and the
medication must be stored in a secured locked storage locker.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 7.

Minnesota Statutes 2007 Supplement, section 152.126, is amended to read:


152.126 SCHEDULE II AND III 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 and 4, 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. new text beginFor the purposes of this section, new text enda dispenser does not
include a licensed hospital pharmacy that distributes controlled substances for inpatient
hospital carenew text begin or a veterinarian who is dispensing prescriptions under section 156.18new text end.

(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.

new text begin Subd. 1a. new text end

new text begin Treatment of intractable pain. new text end

new text begin 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.
new text end

Subd. 2.

Prescription electronic reporting system.

(a) The board shall establish by
January 1, deleted text begin2009deleted text endnew text begin 2010new text end, an electronic system for reporting the information required under
subdivision 4 for all controlled substances dispensed within the state. deleted text beginData 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.
deleted text end

(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.

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) new text begina professional nursing association;
new text end

new text begin (7) a professional dental association;
new text end

new text begin (8) new text enda consumer privacy or security advocate; and

deleted text begin (7)deleted text end new text begin(9) new text enda 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.

(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.

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) new text beginprescription number;
new text end

new text begin (6) new text endname of the patient for whom the prescription was written;

new text begin (7) address of the patient for whom the prescription was written;
new text end

deleted text begin (6)deleted text end new text begin(8) new text enddate of birth of the patient for whom the prescription was written;

deleted text begin (7)deleted text end new text begin(9) new text enddate the prescription was written;

deleted text begin (8)deleted text end new text begin(10) new text enddate the prescription was filled;

deleted text begin (9)deleted text end new text begin(11) new text endname and strength of the controlled substance;

deleted text begin (10)deleted text end new text begin(12) new text endquantity of controlled substance prescribed; deleted text beginand
deleted text end

deleted text begin (11)deleted text end new text begin(13) new text endquantity of controlled substance dispensednew text begin; and
new text end

new text begin (14) number of days supplynew text end.

(b) The dispenser must submit the required information by a procedure and in a
format established by the board.new text begin 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.
new text end

(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 new text begingenerally recognized new text endstandards new text beginof use for those controlled
substances, including standards
new text endaccepted by national and international pain management
associations deleted text beginof dosage for those controlled substancesdeleted text end; 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 12 months from the date
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, to the extent the information relates specifically to a current patient
deleted text begin of the prescriberdeleted text end, to whom the deleted text beginpractitionerdeleted text end new text beginprescriber new text endis prescribing or considering
prescribing any controlled substance;

(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;

(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, 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;

(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.

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 deleted text beginis cost-effective and whether itdeleted text end 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 January
15, deleted text begin2010deleted text endnew text begin 2011new text end.

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. 8. new text begin REPEALER.
new text end

new text begin Minnesota Statutes 2007 Supplement, section 148.235, subdivision 12, new text end new text begin is repealed.
new text end