SF 730

4th Engrossment - 90th Legislature (2017 - 2018) Posted on 05/10/2018 02:38pm

A bill for an act
relating to health; establishing an opiate stewardship program; establishing an
opiate manufacturer registration fee to fund the operation of the prescription
monitoring program; requiring a prescriber to access the prescription monitoring
program before prescribing a controlled substance; limiting the quantity of opiates
and narcotics that can be prescribed for acute pain at any one time; appropriating
money; requiring a report; amending Minnesota Statutes 2016, sections 151.252,
subdivision 1; 151.47, by adding a subdivision; 152.11, subdivisions 1, 2; 152.126,
subdivisions 6, 10; Laws 2017, First Special Session chapter 6, article 12, section
2, subdivision 4; proposing coding for new law in Minnesota Statutes, chapter
151.

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

ARTICLE 1

OPIATE PRODUCT STEWARDSHIP

Section 1.

Minnesota Statutes 2016, section 151.252, subdivision 1, is amended to read:

Subdivision 1.

Requirements.

(a) No person shall act as a drug manufacturer without
first obtaining a license from the board and paying any applicable fee specified in section
151.065.

new text begin (b) In addition to the license required under paragraph (a), a manufacturer of a Schedule
II through IV opiate controlled substance must pay the applicable registration fee specified
in section 151.77, subdivision 3, by June 1 of each year, beginning June 1, 2019. In the
event of a change of ownership of the manufacturer, the new owner must pay the registration
fee specified under section 151.77, subdivision 3, that the original owner would have been
assessed had it retained ownership.
new text end

deleted text begin (b) deleted text end new text begin (c) new text end Application for a drug manufacturer license under this section shall be made in
a manner specified by the board.

deleted text begin (c) deleted text end new text begin (d) new text end No license shall be issued or renewed for a drug manufacturer unless the applicant
agrees to operate in a manner prescribed by federal and state law and according to Minnesota
Rules.

deleted text begin (d) deleted text end new text begin (e) new text end No license shall be issued or renewed for a drug manufacturer that is required to
be registered pursuant to United States Code, title 21, section 360, unless the applicant
supplies the board with proof of registration. The board may establish by rule the standards
for licensure of drug manufacturers that are not required to be registered under United States
Code, title 21, section 360.

deleted text begin (e) deleted text end new text begin (f) new text end No license shall be issued or renewed for a drug manufacturer that is required to
be licensed or registered by the state in which it is physically located unless the applicant
supplies the board with proof of licensure or registration. The board may establish, by rule,
standards for the licensure of a drug manufacturer that is not required to be licensed or
registered by the state in which it is physically located.

deleted text begin (f) deleted text end new text begin (g) new text end The board shall require a separate license for each facility located within the state
at which drug manufacturing occurs and for each facility located outside of the state at
which drugs that are shipped into the state are manufactured.

deleted text begin (g) deleted text end new text begin (h) new text end The board shall not issue an initial or renewed license for a drug manufacturing
facility unless the facility passes an inspection conducted by an authorized representative
of the board. In the case of a drug manufacturing facility located outside of the state, the
board may require the applicant to pay the cost of the inspection, in addition to the license
fee in section 151.065, unless the applicant furnishes the board with a report, issued by the
appropriate regulatory agency of the state in which the facility is located or by the United
States Food and Drug Administration, of an inspection that has occurred within the 24
months immediately preceding receipt of the license application by the board. The board
may deny licensure unless the applicant submits documentation satisfactory to the board
that any deficiencies noted in an inspection report have been corrected.

Sec. 2.

Minnesota Statutes 2016, section 151.47, is amended by adding a subdivision to
read:

new text begin Subd. 1a. new text end

new text begin Controlled substance wholesale drug distributor requirements. new text end

new text begin In addition
to the license required under subdivision 1, a wholesale drug distributor distributing a
Schedule II through IV opiate controlled substance must pay the applicable registration fee
specified in section 151.77 by June 1 of each year beginning June 1, 2019. In the event of
a change in ownership of the wholesale drug distributor, the new owner must pay the
registration fee specified in section 151.77 that the original owner would have been assessed
had it retained ownership.
new text end

Sec. 3.

new text begin [151.75] OPIATE STEWARDSHIP ADVISORY COUNCIL.
new text end

new text begin Subdivision 1. new text end

new text begin Establishment of the advisory council. new text end

new text begin (a) The Opiate Stewardship
Advisory Council is established to develop and implement a comprehensive and effective
statewide effort to address the opioid addiction and overdose epidemic in Minnesota. The
council shall focus on:
new text end

new text begin (1) prevention and education, including public education and awareness for adults and
youth, prescriber education, the development and sustainability of opioid overdose prevention
and education programs, and providing financial support to local law enforcement agencies
for opiate antagonist programs;
new text end

new text begin (2) treatment, including statewide access to effective treatment and recovery services
that is aligned with Minnesota's model of care approach to promoting access to treatment
and recovery services. This includes ensuring that individuals throughout the state have
access to treatment and recovery services, including care coordination services; peer recovery
services; medication-assisted treatment and office-based opioid treatment; integrative and
multidisciplinary therapies; and culturally specific services; and
new text end

new text begin (3) innovation and capacity building, including development of evidence-based practices,
using research and evaluation to understand which policies and programs promote efficient
and effective prevention, treatment, and recovery results. This also includes ensuring that
there are qualified providers and a comprehensive set of treatment and recovery services
throughout the state.
new text end

new text begin (b) The council shall:
new text end

new text begin (1) review local, state, and federal initiatives and funding related to prevention and
education, treatment, and services for individuals and families experiencing and affected
by opioid abuse, and promoting innovation and capacity building to address the opioid
addiction and overdose epidemic;
new text end

new text begin (2) establish priorities to address the state's opioid addiction and overdose epidemic for
the purpose of allocating funds and consult with the commissioner of management and
budget to determine whether proposals are for evidence-based practices, promising practices,
or theory-based practices;
new text end

new text begin (3) ensure that available funding under this section is allocated to align with existing
state and federal funding to achieve the greatest impact and ensure a coordinated state effort
to address the opioid addiction and overdose epidemic;
new text end

new text begin (4) develop criteria and procedures to be used in awarding grants and allocating available
funds from the opiate stewardship account and select proposals to receive grant funding.
The council is encouraged to select proposals that are promising practices or theory-based
practices, in addition to evidence-based practices, to help identify new approaches to effective
prevention, treatment, and recovery; and
new text end

new text begin (5) in consultation with the commissioner of management and budget, and within
available appropriations, select from the awarded grants projects that include promising
practices or theory-based activities for which the commissioner of management and budget
shall conduct evaluations using experimental or quasi-experimental design. Grants awarded
to proposals that include promising practices or theory-based activities and that are selected
for an evaluation shall be administered to support the experimental or quasi-experimental
evaluation and require grantees to collect and report information that is needed to complete
the evaluation. The commissioner of management and budget, under section 15.08, may
obtain additional relevant data to support the experimental or quasi-experimental evaluation
studies.
new text end

new text begin Subd. 2. new text end

new text begin Membership. new text end

new text begin (a) The council shall consist of 18 members appointed by the
commissioner of human services, except as otherwise specified:
new text end

new text begin (1) two members of the house of representatives, one from the majority party appointed
by the speaker of the house and one from the minority party appointed by the minority
leader;
new text end

new text begin (2) two members of the senate, one from the majority party appointed by the senate
majority leader and one from the minority party appointed by the senate minority leader;
new text end

new text begin (3) one member appointed by the Board of Pharmacy;
new text end

new text begin (4) one member who is a physician appointed by the Minnesota chapter of the American
College of Emergency Physicians;
new text end

new text begin (5) one member representing opioid treatment programs or sober living programs;
new text end

new text begin (6) one member who is a physician appointed by the Minnesota Hospital Association;
new text end

new text begin (7) one member who is a physician appointed by the Minnesota Society of Addiction
Medicine;
new text end

new text begin (8) one member who is a pain psychologist;
new text end

new text begin (9) one member appointed by the Steve Rummler Hope Network;
new text end

new text begin (10) one member appointed by the Minnesota Ambulance Association;
new text end

new text begin (11) one member representing the Minnesota courts who is a judge or law enforcement
officer;
new text end

new text begin (12) one public member who is a Minnesota resident and who has been impacted by the
opioid epidemic;
new text end

new text begin (13) one member representing a manufacturer of opiates;
new text end

new text begin (14) one member representing an Indian tribe;
new text end

new text begin (15) the commissioner of human services or designee; and
new text end

new text begin (16) the commissioner of health or designee.
new text end

new text begin (b) The commissioner of human services shall coordinate appointments to provide
geographic diversity and shall ensure that at least one-half of council members reside outside
of the seven-county metropolitan area.
new text end

new text begin (c) The council is governed by section 15.059, except that members of the council shall
receive no compensation other than reimbursement for expenses. Notwithstanding section
15.059, subdivision 6, the council shall not expire.
new text end

new text begin (d) The chair shall convene the council at least quarterly, and may convene other meetings
as necessary. The chair shall convene meetings at different locations in the state to provide
geographic access, and shall ensure that at least one-half of the meetings are held at locations
outside of the seven-county metropolitan area.
new text end

new text begin (e) The commissioner of human services shall provide staff and administrative services
for the advisory council.
new text end

new text begin (f) The council is subject to chapter 13D.
new text end

new text begin Subd. 3. new text end

new text begin Conflict of interest. new text end

new text begin Advisory council members must disclose to the council
and recuse themselves from voting on any matter before the council if the member has a
conflict of interest. A conflict of interest means a financial association that has the potential
to bias or have the appearance of biasing a council member's decision related to the opiate
stewardship grant decision process or other council activities under this section.
new text end

new text begin Subd. 4. new text end

new text begin Grants. new text end

new text begin (a) The commissioner of human services shall submit a report of the
grants proposed by the advisory council to be awarded for the upcoming fiscal year to the
chairs and ranking minority members of the legislative committees with jurisdiction over
health and human services policy and finance, by March 1 of each year, beginning March
1, 2019.
new text end

new text begin (b) The commissioner of human services shall award grants from the opiate stewardship
account under section 151.256. The grants shall be awarded to proposals selected by the
advisory council that address the priorities in paragraph (a), clauses (1) to (3), unless
otherwise appropriated by the legislature. No more than three percent of the grant amount
may be used by a grantee for administration.
new text end

new text begin Subd. 5. new text end

new text begin Reports. new text end

new text begin (a) The advisory council shall report annually to the chairs and ranking
minority members of the legislative committees with jurisdiction over health and human
services policy and finance by January 1 of each year beginning January 1, 2020, information
about the individual projects that receive grants and the role of the grant program overall
in addressing the opioid addiction and overdose epidemic in Minnesota. The report must
describe the grantees and the activities implemented, along with measurable outcomes as
determined by the council in consultation with the commissioner of human services and the
commissioner of management and budget. At a minimum, the report must include information
about the number of individuals who received information or treatment, the outcomes the
individuals achieved, and demographic information about the individuals participating in
the project; an assessment of the progress toward achieving statewide access to qualified
providers and comprehensive treatment and recovery services; and an update on the
evaluation implemented by the commissioner of management and budget for the promising
practices and theory-based projects that receive funding.
new text end

new text begin (b) The commissioner of management and budget, in consultation with the Opiate
Stewardship Advisory Council, shall report annually to the chairs and ranking minority
members of the legislative committees with jurisdiction over health and human services
policy and finance by January 1, beginning January 1, 2021, on the promising practices or
theory-based projects that are selected for evaluation activities. The report shall include
demographic information; outcome information for the individuals in the program; the
results for the program in promoting recovery, employment, family reunification, and
reducing involvement with the criminal justice system; and other relevant outcomes
determined by the commissioner of management and budget that are specific to the projects
that are evaluated. The report shall include information about the ability of grant programs
to be scaled to achieve statewide the results that the grant project demonstrated.
new text end

Sec. 4.

new text begin [151.76] OPIATE STEWARDSHIP ACCOUNT.
new text end

new text begin Subdivision 1. new text end

new text begin Establishment. new text end

new text begin The opiate stewardship account is established in the
special revenue fund in the state treasury. The registration fees collected by the Board of
Pharmacy under section 151.77 shall be deposited into the account.
new text end

new text begin Subd. 2. new text end

new text begin Use of account funds. new text end

new text begin (a) Beginning in fiscal year 2020, money in the account
shall be appropriated each fiscal year as specified in this subdivision.
new text end

new text begin (b) $300,000 is appropriated to the commissioner of management and budget for
evaluation activities under section 151.75.
new text end

new text begin (c) $249,000 is appropriated to the commissioner of human services for the provision
of administrative services to the Opiate Stewardship Advisory Council and for the
administration of the grants awarded under paragraph (f).
new text end

new text begin (d) $33,000 is appropriated to the Board of Pharmacy for the collection of the registration
fees under section 151.77.
new text end

new text begin (e) $384,000 is appropriated to the commissioner of public safety for Bureau of Criminal
Apprehension drug scientists and lab supplies.
new text end

new text begin (f) Money remaining in the opiate stewardship account after making the appropriations
required in paragraphs (b) through (e) is appropriated to the commissioner of human services.
The commissioner shall distribute the appropriation as follows:
new text end

new text begin (1) at least 50 percent shall be distributed to county social service agencies to provide
child protection services to children and families who are affected by addiction. The
commissioner shall distribute this money proportionally to counties based on the number
of open child protection case management cases in the county using data from the previous
calendar year; and
new text end

new text begin (2) the remaining money shall be awarded as specified by the Opiate Stewardship
Advisory Council as grants in accordance with section 151.75, unless otherwise appropriated
by the legislature.
new text end

Sec. 5.

new text begin [151.77] OPIATE PRODUCT REGISTRATION FEE.
new text end

new text begin Subdivision 1. new text end

new text begin Definition. new text end

new text begin For purposes of this section, the following terms have the
meanings given to them in this subdivision:
new text end

new text begin (1) "manufacturer" means a manufacturer licensed under section 151.252 that is engaged
in the manufacturing of an opiate;
new text end

new text begin (2) "opiate" means any opiate-containing controlled substance listed in section 152.02,
subdivisions 3 to 5, that is distributed, delivered, sold, or dispensed into or within this state;
and
new text end

new text begin (3) "wholesaler" means a wholesale drug distributor who is licensed under section 151.47,
and is engaged in the wholesale drug distribution of an opiate.
new text end

new text begin Subd. 2. new text end

new text begin Reporting requirements. new text end

new text begin (a) By March 1 of each year, beginning March 1,
2019, each manufacturer and each wholesale drug distributor must report to the board every
sale, delivery, or other distribution within or into this state of any opiate that is made to any
practitioner, pharmacy, hospital, veterinary hospital, or other person who is permitted by
section 151.37 to possess controlled substances for administration or dispensing to patients
that occurred during the previous calendar year. Reporting must be in the automation of
reports and consolidated orders system format unless otherwise specified by the board. If
a manufacturer fails to provide information required under this paragraph on a timely basis,
the board may assess an administrative penalty of $100 per day. This penalty shall not be
considered a form of disciplinary action.
new text end

new text begin (b) By March 1 of each year, beginning March 1, 2019, each owner of a pharmacy that
is located within this state must report to the board the intracompany delivery or distribution,
into this state, of any opiate, to the extent that those deliveries and distributions are not
reported to the board by a licensed wholesale drug distributor owned by, under contract to,
or otherwise operating on behalf of the owner of the pharmacy. Reporting must be in the
manner and format specified by the board for deliveries and distributions that occurred
during the previous calendar year.
new text end

new text begin Subd. 3. new text end

new text begin Determination of each manufacturer's registration fee. new text end

new text begin (a) The board shall
annually assess manufacturer registration fees that in an aggregate amount total $12,000,000.
The board shall determine each manufacturer's annual registration fee that is prorated and
based on the manufacturer's percentage of the total number of units reported to the board
under subdivision 2.
new text end

new text begin (b) By April 1 of each year, beginning April 1, 2019, the board shall notify each
manufacturer of the annual amount of the manufacturer's registration fee to be paid by June
1, in accordance with section 151.252, subdivision 1, paragraph (b).
new text end

new text begin (c) In conjunction with the data reported under this section, the board may use the data
reported under section 152.126, subdivision 4, to determine the manufacturer registration
fees required under this subdivision.
new text end

new text begin (d) A manufacturer may dispute the registration fee as determined by the board no later
than 30 days after the date of notification. However, the manufacturer must still remit the
fee as required by section 151.252, subdivision 1, paragraph (b). The dispute must be filed
with the board in the manner and using the forms specified by the board. A manufacturer
must submit, with the required forms, data satisfactory to the board that demonstrates that
the registration fee was incorrect. The board must make a decision concerning a dispute no
later than 60 days after receiving the required dispute forms. If the board determines that
the manufacturer has satisfactorily demonstrated that the original fee was incorrect, the
board must adjust the manufacturer's registration fee due the next year by the amount that
is in excess of the correct fee that should have been paid.
new text end

new text begin Subd. 4. new text end

new text begin Determination of each wholesaler's registration fee. new text end

new text begin (a) The board shall
annually assess wholesaler registration fees that in an aggregate amount total $8,000,000.
The board shall determine each wholesaler's annual registration fee that is prorated and
based on the wholesaler's percentage of the total number of units reported to the board under
subdivision 2. This paragraph does not apply to a wholesaler if the wholesaler is also licensed
as a drug manufacturer under section 151.252.
new text end

new text begin (b) By April 1 of each year, beginning April 1, 2019, the board shall notify each
wholesaler, the annual amount of the wholesaler's registration fee to be paid by June 1, in
accordance with section 151.47, subdivision 1a.
new text end

new text begin (c) In conjunction with the data reported under this section, the board may use the data
reported under section 152.126, subdivision 4, to determine the wholesaler registration fees
required under this subdivision.
new text end

new text begin (d) A wholesaler may dispute the registration fee as determined by the board no later
than 30 days after the date of notification. However, the wholesaler must still remit the fee
as required by section 151.252, subdivision 1, paragraph (b). The dispute must be filed with
the board in the manner and using the forms specified by the board. A wholesaler must
submit, with the required forms, data satisfactory to the board that demonstrates that the
registration fee was incorrect. The board must make a decision concerning a dispute no later
than 60 days after receiving the required dispute forms. If the board determines that the
wholesaler has satisfactorily demonstrated that the original fee was incorrect, the board
must adjust the wholesaler's registration fee due the next year by the amount that is in excess
of the correct fee that should have been paid.
new text end

new text begin Subd. 5. new text end

new text begin Deposit. new text end

new text begin Registration fees collected by the board in accordance with this section
shall be deposited in the opiate stewardship account established under section 151.76.
new text end

new text begin Subd. 6. new text end

new text begin Report. new text end

new text begin (a) The Board of Pharmacy shall evaluate the registration fee on drug
manufacturers and wholesalers established under this section, and whether the fee has
impacted the prescribing practices for opiates by reducing the number of opiate prescriptions
issued during calendar years 2019, 2020, and 2021, to the extent the board has the ability
to effectively identify a correlation. Notwithstanding Minnesota Statutes, section 152.126,
subdivision 6, the board may access the data reported under Minnesota Statutes, section
152.126, subdivision 4, to conduct this evaluation.
new text end

new text begin (b) The board shall submit its results of its evaluation to the chairs and ranking minority
members of the legislative committees with jurisdiction over health and human services
policy and finance by March 1, 2022.
new text end

new text begin Subd. 7. new text end

new text begin Legislative review. new text end

new text begin The legislature shall review the reports from the Opiate
Stewardship Advisory Council under section 151.75, subdivision 5, paragraph (a), the reports
from the commissioner of management and budget on the Results First evaluation activities
under section 151.75, subdivision 5, paragraph (b), the report from the Board of Pharmacy
under subdivision 5, and any other relevant report or information related to the opioid crisis
in Minnesota, to make a determination about whether the opiate product registration fee
under this section should continue beyond July 1, 2022.
new text end

Sec. 6. new text begin OPIATE STEWARDSHIP ADVISORY COUNCIL FIRST MEETING.
new text end

new text begin The commissioner of human services shall convene the first meeting of the Opiate
Stewardship Advisory Council established under Minnesota Statutes, section 151.75, no
later than October 1, 2018. The members shall elect a chair at the first meeting.
new text end

Sec. 7. new text begin APPROPRIATIONS.
new text end

new text begin (a) $52,000 in fiscal year 2019 is appropriated from the special revenue fund to the
Board of Pharmacy for the administrative fees related to the collection of the registration
fee under Minnesota Statutes, section 151.77. This is a onetime appropriation.
new text end

new text begin (b) $131,000 in fiscal year 2019 is appropriated from the special revenue fund to the
commissioner of human services for administration of the Opioid Product Stewardship
Advisory Council established under Minnesota Statutes, section 151.75. This is a onetime
appropriation.
new text end

new text begin (c) $384,000 in fiscal year 2019 is appropriated from the special revenue fund to the
commissioner of public safety for Bureau of Criminal Apprehension drug scientists and lab
supplies.
new text end

ARTICLE 2

OTHER OPIATE PROVISIONS

Section 1.

Minnesota Statutes 2016, section 152.11, subdivision 1, is amended to read:

Subdivision 1.

General prescription requirements for controlled substances.

(a) A
written prescription or an oral prescription reduced to writing, when issued 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 handwritten signature, address, and federal registry
number 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.

(b) An electronic prescription for a controlled substance in Schedule II, III, IV, or V is
void unless it complies with the standards established pursuant to section 62J.497 and with
those portions of Code of Federal Regulations, title 21, parts 1300, 1304, 1306, and 1311,
that pertain to electronic prescriptions.

(c) A prescription for a controlled substance in Schedule II, III, IV, or V that is transmitted
by facsimile, either computer to facsimile machine or facsimile machine to facsimile machine,
is void unless it complies with the applicable requirements of Code of Federal Regulations,
title 21, part 1306.

(d) Every licensed pharmacy that dispenses a controlled substance prescription shall
retain the original 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. An original electronic or facsimile
prescription may be stored in an electronic database, provided that the database provides a
means by which original prescriptions can be retrieved, as transmitted to the pharmacy, for
a period of not less than two years.

(e) Every licensed pharmacy shall distinctly label the container in which a controlled
substance is dispensed with the directions contained in the prescription for the use of that
controlled substance.

new text begin (f) No prescription for an opiate or narcotic pain reliever listed in Schedules II through
IV of section 152.02 shall be dispensed more than 30 days after the date on which the
prescription was issued. After 30 days from the date of issuance of the prescription, no
additional authorizations may be accepted for that prescription. If continued therapy is
necessary, a new prescription must be issued by the prescriber.
new text end

Sec. 2.

Minnesota Statutes 2016, section 152.11, subdivision 2, is amended to read:

Subd. 2.

Prescription requirements for Schedule III or IV controlled substances.

No person may dispense a controlled substance included in Schedule III or IV of section
152.02 without a prescription issued, as permitted under subdivision 1, by a doctor of
medicine, a doctor of osteopathic medicine 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
documented consent of the prescriber, deleted text begin and in no event more than six months after the date
on which such prescription was issued deleted text end and no such prescription may be refilled more than
five times.

Sec. 3.

Minnesota Statutes 2016, 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;

(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

(iv) providing other medical treatment for which access to the data may be necessary
for a clinically valid purpose 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 care: (i) if the patient has
consented to access to the submitted data; or (ii) if the pharmacist is consulted by a prescriber
who is requesting data in accordance with clause (1);

(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 new text begin . For purposes of this clause, access by individuals includes persons in the
definition of an individual under section 13.02 new text end ;

(5) personnel or designees of a health-related licensing board listed in section 214.01,
subdivision 2, or of the Emergency Medical Services Regulatory Board, assigned to conduct
a bona fide investigation of a complaint received by that board that alleges that a specific
licensee 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);

(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 (i);

(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 deleted text begin . deleted text end new text begin ; and
new text end

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

(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.

(c) By 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.

(d) new text begin Notwithstanding paragraph (b), beginning January 1, 2020, a prescriber or an agent
or employee of the prescriber to whom the prescriber has delegated the task of accessing
the data, must access the data submitted under subdivision 4 to the extent the information
relates specifically to the patient before the prescriber issues a prescription order for a
controlled substance to the patient. This paragraph does not apply if:
new text end

new text begin (1) the patient is receiving hospice care;
new text end

new text begin (2) the prescription order is for a number of doses that is intended to last the patient five
days or less and is not subject to a refill;
new text end

new text begin (3) the controlled substance is lawfully administered by injection, ingestion, or any other
means to the patient by the prescriber, a pharmacist, or by the patient at the direction of a
prescriber and in the presence of the prescriber or pharmacist;
new text end

new text begin (4) the prescriber is a veterinarian and the patient is an animal under the care of the
veterinarian;
new text end

new text begin (5) due to an emergency, it is not possible for the prescriber to review the data before
the prescriber issues the prescription order for the patient; or
new text end

new text begin (6) the prescriber is unable to access the data due to operational or other technological
failure of the program so long as the prescriber reports the failure to the board.
new text end

new text begin (e) new text end Only permissible users identified in paragraph (b), clauses (1), (2), (3), (6), (7), (9),
and (10), may directly access the data electronically. No other permissible users may directly
access the data electronically. 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 (e) deleted text end new text begin (f) 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 (f) deleted text end new text begin (g) 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 (g) deleted text end new text begin (h) 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 (h) deleted text end new text begin (i) 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 begin (i) deleted text end new text begin (j) 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 (j) deleted text end new text begin (k) 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.

Sec. 4.

Minnesota Statutes 2016, section 152.126, subdivision 10, is amended to read:

Subd. 10.

Funding.

(a) The board may seek grants and private funds from nonprofit
charitable foundations, the federal government, and other sources to fund the enhancement
and ongoing operations of the prescription monitoring program established under this section.
Any funds received shall be appropriated to the board for this purpose. The board may not
expend funds to enhance the program in a way that conflicts with this section without seeking
approval from the legislature.

(b) Notwithstanding any other section, the administrative services unit for the
health-related licensing boards shall apportion between the Board of Medical Practice, the
Board of Nursing, the Board of Dentistry, the Board of Podiatric Medicine, the Board of
Optometry, the Board of Veterinary Medicine, and the Board of Pharmacy an amount to be
paid through fees by each respective board. The amount apportioned to each board shall
equal each board's share of the annual appropriation to the Board of Pharmacy from the
state government special revenue fund for operating the prescription monitoring program
under this section. Each board's apportioned share shall be based on the number of prescribers
or dispensers that each board identified in this paragraph licenses as a percentage of the
total number of prescribers and dispensers licensed collectively by these boards. Each
respective board may adjust the fees that the boards are required to collect to compensate
for the amount apportioned to each board by the administrative services unit.

new text begin (c) The board shall have the authority to modify its contract with its vendor as provided
in subdivision 2, to authorize that vendor to provide a service to prescribers and pharmacies
that allows them to access prescription monitoring program data from within the electronic
health record system or pharmacy software used by those prescribers and pharmacists.
Beginning July 1, 2018, the board has the authority to collect an annual fee from each
prescriber or pharmacist who accesses prescription monitoring program data through the
service offered by the vendor. The annual fee collected must not exceed $50 per user. The
fees collected by the board under this paragraph shall be deposited in the state government
special revenue fund and is appropriated to the board for the purposes of this paragraph.
new text end

Sec. 5.

Laws 2017, First Special Session chapter 6, article 12, section 2, subdivision 4, is
amended to read:

Subd. 4.

Limit on quantity of opiates prescribed deleted text begin for acute dental and ophthalmic
pain deleted text end .

new text begin (a) When used for the treatment of acute pain, prescriptions for opiates or narcotic
pain relievers listed in Schedules II through IV in section 152.02 shall not exceed a seven-day
supply for an adult and shall not exceed a five-day supply for a minor under 18 years of
age.
new text end

deleted text begin (a) deleted text end new text begin (b) Notwithstanding paragraph (a), new text end when used for the treatment of acute dental pain
or acute pain associated with refractive surgery, prescriptions for opiate or narcotic pain
relievers listed in Schedules II through IV of section 152.02 shall not exceed a four-day
supply. deleted text begin The quantity prescribed shall be consistent with the dosage listed in the professional
labeling for the drug that has been approved by the United States Food and Drug
Administration.
deleted text end

deleted text begin (b) deleted text end new text begin (c) new text end For the purposes of this subdivision, "acute pain" means pain resulting from
disease, accidental or intentional trauma, surgery, or another cause, that the practitioner
reasonably expects to last only a short period of time. Acute pain does not include chronic
pain or pain being treated as part of cancer care, palliative care, or hospice or other end-of-life
care.

deleted text begin (c) Notwithstanding paragraph (a), if in the professional clinical judgment of a practitioner
more than a four-day supply of a prescription listed in Schedules II through IV of section
152.02 is required to treat a patient's acute pain, the practitioner may issue a prescription
for the quantity needed to treat such acute pain.
deleted text end