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SF 1440

4th Engrossment - 89th Legislature (2015 - 2016) Posted on 09/28/2016 09:26am

KEY: stricken = removed, old language.
underscored = added, new language.
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A bill for an act
relating to health; making changes to the Minnesota prescription monitoring
program; amending Minnesota Statutes 2014, section 152.126, subdivisions 1, 3,
5, 6; repealing Laws 2014, chapter 286, article 7, section 4.

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

Section 1.

Minnesota Statutes 2014, section 152.126, subdivision 1, is amended to read:


Subdivision 1.

Definitions.

(a) For purposes of this section, the terms defined in
this subdivision have the meanings given.

(b) "Board" means the Minnesota State Board of Pharmacy established under
chapter 151.

(c) "Controlled substances" means those substances listed in section 152.02,
subdivisions 3 to 6, and those substances defined by the board pursuant to section 152.02,
subdivisions 7
, 8, and 12. For the purposes of this section, controlled substances includes
deleted text begintramadol anddeleted text end butalbitalnew text begin and gabapentinnew text end.

(d) "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.

(e) "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.

(f) "Prescriber" means a licensed health care professional who is authorized to
prescribe a controlled substance under section 152.12, subdivision 1 or 2.

(g) "Prescription" has the meaning given in section 151.01, subdivision deleted text begin16deleted text endnew text begin 16anew text end.

Sec. 2.

Minnesota Statutes 2014, section 152.126, subdivision 3, is amended to read:


Subd. 3.

Prescription Monitoring Program Advisory Task Force.

(a) The board
shall appoint an advisory task force consisting of 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;

(9) a consumer or patient rights organization; and

(10) an association of medical examiners and coroners.

(b) The advisory task force shall advise the board on the development and operation
of the prescription monitoring program, including, but not limited to:

(1) technical standards for electronic prescription drug reporting;

(2) proper analysis and interpretation of prescription monitoring data;

(3) an evaluation process for the program; and

(4) criteria for the unsolicited provision of prescription monitoring data by the
board to prescribers and dispensers.

(c) The task force is governed by section 15.059. new text beginNotwithstanding any other
provisions of law to the contrary,
new text endthe task force shall not expire.

Sec. 3.

Minnesota Statutes 2014, section 152.126, subdivision 5, is amended to read:


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. Except as otherwise allowed
under subdivision 6, 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 deleted text beginor
substantiate
deleted text end a disciplinary action against a prescriber.

(d) Data reported under subdivision 4 shall be made available to permissible users for
a 12-month period beginning the day the data was received and ending 12 months from the
last day of the month in which the data was received, except that permissible users defined
in subdivision 6, paragraph (b), clauses (6) and (7), may use all data collected under this
section for the purposes of administering, operating, and maintaining the prescription
monitoring program and conducting trend analyses and other studies necessary to evaluate
the effectiveness of the program. deleted text beginData retained beyond 24 months must be de-identified.
deleted text end

deleted text begin (e) The board shall not retain data reported under subdivision 4 for a period longer
than four years from the date the data was received.
deleted text end

new text begin (e) Data reported during the period January 1, 2015, through December 31, 2018,
may be retained through December 31, 2019, in an identifiable manner. Effective January
1, 2020, data older than 24 months must be destroyed. Data reported on or after January 1,
2020, must be destroyed no later than 12 months from the date the data was received.
new text end

Sec. 4.

Minnesota Statutes 2014, section 152.126, subdivision 6, is amended to read:


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 or an agent or employee of the prescriber to whom the prescriber has
delegated the task of accessing the data, to the extent the information relates specifically to
a current patient, to whom the prescriber is:

(i) prescribing or considering prescribing any controlled substance;

(ii) providing emergency medical treatment for which access to the data may be
necessary; deleted text beginordeleted text end

new text begin (iii) providing care, and the prescriber has reason to believe, based on clinically valid
indications, that the patient is potentially abusing a controlled substance; or
new text end

deleted text begin (iii)deleted text endnew text begin (iv)new text end providing other medical treatment for which access to the data may be
necessary new text beginfor a clinically valid purposenew text end and the patient has consented to access to the
submitted data, and with the provision that the prescriber remains responsible for the use
or misuse of data accessed by a delegated agent or employee;

(2) a dispenser or an agent or employee of the dispenser to whom the dispenser has
delegated the task of accessing the data, to the extent the information relates specifically
to a current patient to whom that dispenser is dispensing or considering dispensing any
controlled substance and with the provision that the dispenser remains responsible for the
use or misuse of data accessed by a delegated agent or employee;

(3) a licensed pharmacist who is providing pharmaceutical care for which access
to the data may be necessary to the extent that the information relates specifically to a
current patient for whom the pharmacist is providing pharmaceutical carenew text begin: (i)new text end if the patient
has consented to access to the submitted datanew text begin; or (ii) if the pharmacist is consulted by a
prescriber who is requesting data in accordance with clause (1)
new text end;

(4) 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;

(5) personnel new text beginor designees new text endof deleted text beginthedeleted text endnew text begin a health-related licensingnew text end board deleted text beginspecificallydeleted text endnew text begin listed
in section 214.01, subdivision 2, or of the Emergency Medical Services Regulatory Board,
new text end
assigned to conduct a bona fide investigation of a new text begincomplaint received by that board that
alleges that a
new text endspecific licenseenew text begin is impaired by use of a drug for which data is collected
under subdivision 4, has engaged in activity that would constitute a crime as defined in
section 152.025, or has engaged in the behavior specified in subdivision 5, paragraph (a)
new text end;

(6) personnel of the board engaged in the collection, review, and analysis
of controlled substance prescription information as part of the assigned duties and
responsibilities under this section;

(7) authorized personnel of a vendor under contract with the state of Minnesota who
are engaged in the design, implementation, operation, and maintenance of the prescription
monitoring program 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, and subject to the requirement of de-identification and time
limit on retention of data specified in subdivision 5, paragraphs (d) and (e);

(8) federal, state, and local law enforcement authorities acting pursuant to a valid
search warrant;

(9) personnel of the Minnesota health care programs assigned to use the data
collected under this section to identify and manage recipients whose usage of controlled
substances may warrant restriction to a single primary care provider, a single outpatient
pharmacy, and a single hospital;

(10) personnel of the Department of Human Services assigned to access the data
pursuant to paragraph deleted text begin(h)deleted text endnew text begin (i)new text end; deleted text beginand
deleted text end

(11) personnel of the health professionals services program established under section
214.31, to the extent that the information relates specifically to an individual who is
currently enrolled in and being monitored by the program, and the individual consents to
access to that information. The health professionals services program personnel shall not
provide this data to a health-related licensing board or the Emergency Medical Services
Regulatory Board, except as permitted under section 214.33, subdivision 3.

For purposes of clause (4), access by an individual includes persons in the definition
of an individual under section 13.02deleted text begin.deleted text endnew text begin; and
new text end

new text begin (12) personnel or designees of a health-related licensing board listed in section
214.01, subdivision 2, assigned to conduct a bona fide investigation of a complaint
received by that board that alleges that a specific licensee is inappropriately prescribing
controlled substances as defined in this section.
new text end

(c) new text beginBy July 1, 2017, every prescriber licensed by a health-related licensing board
listed in section 214.01, subdivision 2, practicing within this state who is authorized to
prescribe controlled substances for humans and who holds a current registration issued
by the federal Drug Enforcement Administration, and every pharmacist licensed by the
board and practicing within the state, shall register and maintain a user account with the
prescription monitoring program. Data submitted by a prescriber, pharmacist, or their
delegate during the registration application process, other than their name, license number,
and license type, is classified as private pursuant to section 13.02, subdivision 12.
new text end

new text begin (d) new text enddeleted text beginAdeleted text end new text beginOnlynew text end permissible deleted text beginuserdeleted text end new text beginusersnew text end identified in paragraph (b), clauses (1), (2), (3), (6),
(7), (9), and (10), may directly access the data electronically. new text beginNo other permissible users
may directly access the data electronically.
new text end If the data is directly accessed electronically,
the permissible user 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.

deleted text begin (d)deleted text endnew text begin (e)new text end The board shall not release data submitted under subdivision 4 unless it
is provided with evidence, satisfactory to the board, that the person requesting the
information is entitled to receive the data.

deleted text begin (e)deleted text endnew text begin (f)new text end The board shall maintain a log of all persons who access the data for a period
of at least three years and shall ensure that any permissible user complies with paragraph
(c) prior to attaining direct access to the data.

deleted text begin (f)deleted text endnew text begin (g)new text end 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.

deleted text begin (g)deleted text endnew text begin (h)new text end The board may participate in an interstate prescription monitoring program
data exchange system provided that permissible users in other states have access to the
data only as allowed under this section, and that section 13.05, subdivision 6, applies
to any contract or memorandum of understanding that the board enters into under this
paragraph. deleted text beginThe board shall report to the chairs and ranking minority members of the senate
deleted text enddeleted text beginand house of representatives committees with jurisdiction over health and human services
deleted text enddeleted text beginpolicy and finance on the interstate prescription monitoring program by January 5, 2016.
deleted text end

deleted text begin (h)deleted text endnew text begin (i)new text end With available appropriations, the commissioner of human services shall
establish and implement a system through which the Department of Human Services shall
routinely access the data for the purpose of determining whether any client enrolled in
an opioid treatment program licensed according to chapter 245A has been prescribed or
dispensed a controlled substance in addition to that administered or dispensed by the
opioid treatment program. When the commissioner determines there have been multiple
prescribers or multiple prescriptions of controlled substances, the commissioner shall:

(1) inform the medical director of the opioid treatment program only that the
commissioner determined the existence of multiple prescribers or multiple prescriptions of
controlled substances; and

(2) direct the medical director of the opioid treatment program to access the data
directly, review the effect of the multiple prescribers or multiple prescriptions, and
document the review.

If determined necessary, the commissioner of human services shall seek a federal waiver
of, or exception to, any applicable provision of Code of Federal Regulations, title 42,
section 2.34, paragraph (c), prior to implementing this paragraph.

deleted text begin (i)deleted text endnew text begin (j)new text end The board shall review the data submitted under subdivision 4 on at least a
quarterly basis and shall establish criteria, in consultation with the advisory task force,
for referring information about a patient to prescribers and dispensers who prescribed or
dispensed the prescriptions in question if the criteria are met. deleted text beginThe board shall report
deleted text enddeleted text beginto the chairs and ranking minority members of the senate and house of representatives
deleted text enddeleted text begincommittees with jurisdiction over health and human services policy and finance on the
deleted text enddeleted text begincriteria established under this paragraph and the review process by January 5, 2016. This
deleted text enddeleted text beginparagraph expires August 1, 2016.
deleted text end

Sec. 5. new text begin REPEALER.
new text end

new text begin Laws 2014, chapter 286, article 7, section 4, new text end new text begin is repealed.
new text end

APPENDIX

Repealed Minnesota Session Laws: S1440-4

Laws 2014, chapter 286, article 7, section 4 by Laws 2016, chapter 185, section 5