HF 400

6th Engrossment - 91st Legislature (2019 - 2020) Posted on 05/23/2019 09:51am

A bill for an act
relating to health; establishing the opiate product registration fee and the Opiate
Epidemic Response Advisory Council; modifying certain licensure and registration
fees; modifying sections relating to prescription drugs and controlled substances;
requiring reports; appropriating money; amending Minnesota Statutes 2018, sections
16A.151, subdivision 2; 145C.05, subdivision 2; 151.01, subdivision 27; 151.065,
subdivisions 1, 3, by adding a subdivision; 151.252, subdivision 1; 151.37,
subdivision 12; 152.105, subdivision 2; 152.11, subdivisions 1, 2d, 4; 152.126,
subdivision 6; 214.12, by adding a subdivision; proposing coding for new law in
Minnesota Statutes, chapters 145C; 151; 256.

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

ARTICLE 1

OPIATE EPIDEMIC RESPONSE

Section 1.

Minnesota Statutes 2018, section 16A.151, subdivision 2, is amended to read:

Subd. 2.

Exceptions.

(a) If a state official litigates or settles a matter on behalf of specific
injured persons or entities, this section does not prohibit distribution of money to the specific
injured persons or entities on whose behalf the litigation or settlement efforts were initiated.
If money recovered on behalf of injured persons or entities cannot reasonably be distributed
to those persons or entities because they cannot readily be located or identified or because
the cost of distributing the money would outweigh the benefit to the persons or entities, the
money must be paid into the general fund.

(b) Money recovered on behalf of a fund in the state treasury other than the general fund
may be deposited in that fund.

(c) This section does not prohibit a state official from distributing money to a person or
entity other than the state in litigation or potential litigation in which the state is a defendant
or potential defendant.

(d) State agencies may accept funds as directed by a federal court for any restitution or
monetary penalty under United States Code, title 18, section 3663(a)(3) or United States
Code, title 18, section 3663A(a)(3). Funds received must be deposited in a special revenue
account and are appropriated to the commissioner of the agency for the purpose as directed
by the federal court.

(e) Tobacco settlement revenues as defined in section 16A.98, subdivision 1, paragraph
(t), may be deposited as provided in section 16A.98, subdivision 12.

new text begin (f) Any money received by the state resulting from a settlement agreement or an assurance
of discontinuance entered into by the attorney general of the state, or a court order in litigation
brought by the attorney general of the state, on behalf of the state or a state agency, against
one or more opioid manufacturers or opioid wholesale drug distributors related to alleged
violations of consumer fraud laws in the marketing, sale, or distribution of opioids in this
state or other alleged illegal actions that contributed to the excessive use of opioids, must
be deposited in a separate account in the state treasury and the commissioner shall notify
the chairs and ranking minority members of the finance committee in the senate and the
ways and means committee in the house of representatives that an account has been created.
This paragraph does not apply to attorney fees and costs awarded to the state or the Attorney
General's Office, to contract attorneys hired by the state or Attorney General's Office, or to
other state agency attorneys. If the licensing fees under section 151.065, subdivision 1,
clause (16), and section 151.065, subdivision 3, clause (14), are reduced and the registration
fee under section 151.066, subdivision 3, is repealed in accordance with section 256.043,
subdivision 4, then the commissioner shall transfer from the separate account created in
this paragraph to the opiate epidemic response account under section 256.043 an amount
that ensures that $20,940,000 each fiscal year is available for distribution in accordance
with section 256.043, subdivisions 2 and 3.
new text end

Sec. 2.

Minnesota Statutes 2018, section 151.065, subdivision 1, is amended to read:

Subdivision 1.

Application fees.

Application fees for licensure and registration are as
follows:

(1) pharmacist licensed by examination, $145;

(2) pharmacist licensed by reciprocity, $240;

(3) pharmacy intern, $37.50;

(4) pharmacy technician, $37.50;

(5) pharmacy, $225;

(6) drug wholesaler, legend drugs only, deleted text begin $235 deleted text end new text begin $5,000 new text end ;

(7) drug wholesaler, legend and nonlegend drugs, deleted text begin $235 deleted text end new text begin $5,000 new text end ;

(8) drug wholesaler, nonlegend drugs, veterinary legend drugs, or both, deleted text begin $210 deleted text end new text begin $5,000 new text end ;

(9) drug wholesaler, medical gases, deleted text begin $175 deleted text end new text begin $5,000 new text end ;

(10) drug wholesaler, also licensed as a pharmacy in Minnesota, deleted text begin $150 deleted text end new text begin $5,000 new text end ;

(11) drug manufacturer, new text begin nonopiate new text end legend drugs only, deleted text begin $235 deleted text end new text begin $5,000 new text end ;

(12) drug manufacturer, new text begin nonopiate new text end legend and nonlegend drugs, deleted text begin $235 deleted text end new text begin $5,000 new text end ;

(13) drug manufacturer, nonlegend or veterinary legend drugs, deleted text begin $210 deleted text end new text begin $5,000 new text end ;

(14) drug manufacturer, medical gases, deleted text begin $185 deleted text end new text begin $5,000 new text end ;

(15) drug manufacturer, also licensed as a pharmacy in Minnesota, deleted text begin $150 deleted text end new text begin $5,000 new text end ;

new text begin (16) drug manufacturer of opiate-containing controlled substances listed in section
152.02, subdivisions 3 to 5, $55,000;
new text end

deleted text begin (16) deleted text end new text begin (17) new text end medical gas distributor, deleted text begin $110 deleted text end new text begin $5,000 new text end ;

deleted text begin (17) deleted text end new text begin (18) new text end controlled substance researcher, $75; and

deleted text begin (18) deleted text end new text begin (19) new text end pharmacy professional corporation, $125.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective July 1, 2019, and applies to any license
issued on or after that date.
new text end

Sec. 3.

Minnesota Statutes 2018, section 151.065, subdivision 3, is amended to read:

Subd. 3.

Annual renewal fees.

Annual licensure and registration renewal fees are as
follows:

(1) pharmacist, $145;

(2) pharmacy technician, $37.50;

(3) pharmacy, $225;

(4) drug wholesaler, legend drugs only, deleted text begin $235 deleted text end new text begin $5,000 new text end ;

(5) drug wholesaler, legend and nonlegend drugs, deleted text begin $235 deleted text end new text begin $5,000 new text end ;

(6) drug wholesaler, nonlegend drugs, veterinary legend drugs, or both, deleted text begin $210 deleted text end new text begin $5,000 new text end ;

(7) drug wholesaler, medical gases, deleted text begin $185 deleted text end new text begin $5,000 new text end ;

(8) drug wholesaler, also licensed as a pharmacy in Minnesota, deleted text begin $150 deleted text end new text begin $5,000 new text end ;

(9) drug manufacturer, new text begin nonopiate new text end legend drugs only, deleted text begin $235 deleted text end new text begin $5,000 new text end ;

(10) drug manufacturer, new text begin nonopiate new text end legend and nonlegend drugs, deleted text begin $235 deleted text end new text begin $5,000 new text end ;

(11) drug manufacturer, nonlegend, veterinary legend drugs, or both, deleted text begin $210 deleted text end new text begin $5,000 new text end ;

(12) drug manufacturer, medical gases, deleted text begin $185 deleted text end new text begin $5,000 new text end ;

(13) drug manufacturer, also licensed as a pharmacy in Minnesota, deleted text begin $150 deleted text end new text begin $5,000 new text end ;

new text begin (14) drug manufacturer of opiate-containing controlled substances listed in section
152.02, subdivisions 3 to 5, $55,000;
new text end

deleted text begin (14) deleted text end new text begin (15) new text end medical gas distributor, deleted text begin $110 deleted text end new text begin $5,000 new text end ;

deleted text begin (15) deleted text end new text begin (16) new text end controlled substance researcher, $75; and

deleted text begin (16) deleted text end new text begin (17) new text end pharmacy professional corporation, $75.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective July 1, 2019, and applies to any license
renewed on or after that date.
new text end

Sec. 4.

Minnesota Statutes 2018, section 151.065, is amended by adding a subdivision to
read:

new text begin Subd. 7. new text end

new text begin Deposit of fees. new text end

new text begin (a) The license fees collected under this section, with the
exception of the fees identified in paragraphs (b) and (c), shall be deposited in the state
government special revenue fund.
new text end

new text begin (b) $5,000 of each fee collected under subdivision 1, clauses (6) to (15) and (17), and
subdivision 3, clauses (4) to (13) and (15), and the fees collected under subdivision 1, clause
(16), and subdivision 3, clause (14), shall be deposited in the opiate epidemic response
account established in section 256.043.
new text end

new text begin (c) If the fees collected under subdivision 1, clause (16), or subdivision 3, clause (14),
are reduced, $5,000 of the reduced fee shall be deposited in the opiate epidemic response
account in section 256.043.
new text end

Sec. 5.

new text begin [151.066] 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 (a) For purposes of this section, the following terms have the
meanings given to them in this subdivision.
new text end

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

new text begin (c) "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.
new text end

new text begin (d) "Wholesaler" means a wholesale drug distributor licensed under section 151.47 that
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,
2020, each manufacturer and each wholesaler 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
or wholesaler fails to provide information required under this paragraph on a timely basis,
the board may assess an administrative penalty of $500 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, 2020, each owner of a pharmacy with
at least one location within this state must report to the board any 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 wholesaler 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. The report must include the name of the manufacturer
or wholesaler from which the owner of the pharmacy ultimately purchased the opiate, and
the amount and date that the purchase occurred.
new text end

new text begin Subd. 3. new text end

new text begin Determination of an opiate product registration fee. new text end

new text begin (a) The board shall
annually assess an opiate product registration fee on any manufacturer of an opiate that
annually sells, delivers, or distributes an opiate within or into the state 2,000,000 or more
units as reported to the board under subdivision 2.
new text end

new text begin (b) The annual registration fee for each manufacturer meeting the requirement under
paragraph (a) is $250,000.
new text end

new text begin (c) In conjunction with the data reported under this section, and notwithstanding section
152.126, subdivision 6, the board may use the data reported under section 152.126,
subdivision 4, to determine which manufacturers meet the requirement under paragraph (a)
and are required to pay the registration fees under this subdivision.
new text end

new text begin (d) By April 1 of each year, beginning April 1, 2020, the board shall notify a manufacturer
that the manufacturer meets the requirement in paragraph (a) and is required to pay the
annual registration fee in accordance with section 151.252, subdivision 1, paragraph (b).
new text end

new text begin (e) A manufacturer may dispute the board's determination that the manufacturer must
pay the registration fee 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 assessment of 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 fee was incorrectly assessed, the board must refund the amount paid in error.
new text end

new text begin (f) For purposes of this subdivision, a unit means the individual dosage form of the
particular drug product that is prescribed to the patient. One unit equals one tablet, capsule,
patch, syringe, milliliter, or gram.
new text end

new text begin Subd. 4. 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 established under this section, and whether the registration fee and the
increased licensure fees have impacted the prescribing practices of opiates by reducing the
number of opiate prescriptions issued during calendar years 2021, 2022, and 2023, or creating
any unintended consequences in the availability of opiates for the treatment of chronic or
intractable pain to the extent the board has the ability to effectively identify a correlation.
Notwithstanding section 152.126, subdivision 6, the board may access the data reported
under section 152.126, subdivision 4, to conduct this evaluation.
new text end

new text begin (b) The board shall submit the 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, 2024.
new text end

new text begin Subd. 5. new text end

new text begin Legislative review. new text end

new text begin The legislature shall review the reports from the Opiate
Epidemic Response Advisory Council under section 256.042, subdivision 5, paragraph (a),
the reports from the commissioner of management and budget on the Results First evaluation
activities under section 256.042, subdivision 5, paragraph (b), the report from the Board of
Pharmacy under subdivision 4, 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 assessed under this section should continue beyond July 1, 2024.
new text end

Sec. 6.

Minnesota Statutes 2018, 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), each manufacturer required
to pay the registration fee under section 151.066 must pay the fee by June 1 of each year,
beginning June 1, 2020. In the event of a change of ownership of the manufacturer, the new
owner must pay the registration fee specified under section 151.066, subdivision 3, that the
original owner would have been assessed had the original owner retained ownership. The
registration fee collected under this paragraph shall be deposited in the opiate epidemic
response account established under section 256.043.
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 new text begin , except a manufacturer of
opiate-containing controlled substances shall not be required to pay the fee under section
151.065, subdivision 1, clause (16), or 151.065, subdivision 3, clause (14), for more than
one facility new text end .

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. 7.

new text begin [256.042] OPIATE EPIDEMIC RESPONSE 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 Epidemic
Response 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, the role of adult protective services in prevention and response,
and providing financial support to local law enforcement agencies for opiate antagonist
programs;
new text end

new text begin (2) training on the treatment of opioid addiction, including the use of all Food and Drug
Administration approved opioid addiction medications, detoxification, relapse prevention,
patient assessment, individual treatment planning, counseling, recovery supports, diversion
control, and other best practices;
new text end

new text begin (3) the expansion and enhancement of a continuum of care for opioid-related substance
use disorders, including primary prevention, early intervention, treatment, recovery, and
aftercare services; and
new text end

new text begin (4) the development of measures to assess and protect the ability of cancer patients and
survivors, persons battling life threatening illnesses, persons suffering from severe chronic
pain, and persons at the end stages of life, who legitimately need prescription pain
medications, to maintain their quality of life by accessing these pain medications without
facing unnecessary barriers. The measures must also address the needs of individuals
described in this clause who are elderly or who reside in underserved or rural areas of 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 activities related to education,
prevention, treatment, and services for individuals and families experiencing and affected
by opioid use disorder;
new text end

new text begin (2) establish priorities to address the state's opioid epidemic, for the purpose of
recommending initiatives to fund;
new text end

new text begin (3) recommend to the commissioner of human services specific projects and initiatives
to be funded;
new text end

new text begin (4) ensure that available funding is allocated to align with other state and federal funding,
to achieve the greatest impact and ensure a coordinated state effort;
new text end

new text begin (5) consult with the commissioners of human services, health, and management and
budget to develop measurable outcomes to determine the effectiveness of funds allocated;
and
new text end

new text begin (6) develop recommendations for an administrative and organizational framework for
the allocation, on a sustainable and ongoing basis, of any money deposited into the separate
account under section 16A.151, subdivision 2, paragraph (f), in order to address the opioid
abuse and overdose epidemic in Minnesota and the areas of focus specified in paragraph
(a).
new text end

new text begin (c) The council, in consultation with the commissioner of management and budget, and
within available appropriations, shall 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 (d) The council, in consultation with the commissioners of human services, health, public
safety, and management and budget, shall establish goals related to addressing the opioid
epidemic and determine a baseline against which progress shall be monitored and set
measurable outcomes, including benchmarks. The goals established must include goals for
prevention and public health, access to treatment, and multigenerational impacts. The council
shall use existing measures and data collection systems to determine baseline data against
which progress shall be measured. The council shall include the proposed goals, the
measurable outcomes, and proposed benchmarks to meet these goals in its initial report to
the legislature under subdivision 5, paragraph (a), due January 31, 2021.
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 the following 19 voting members,
appointed by the commissioner of human services except as otherwise specified, and three
nonvoting members:
new text end

new text begin (1) two members of the house of representatives, appointed in the following sequence:
the first from the majority party appointed by the speaker of the house and the second from
the minority party appointed by the minority leader. Of these two members, one member
must represent a district outside of the seven-county metropolitan area, and one member
must represent a district that includes the seven-county metropolitan area. The appointment
by the minority leader must ensure that this requirement for geographic diversity in
appointments is met;
new text end

new text begin (2) two members of the senate, appointed in the following sequence: the first from the
majority party appointed by the senate majority leader and the second from the minority
party appointed by the senate minority leader. Of these two members, one member must
represent a district outside of the seven-county metropolitan area and one member must
represent a district that includes the seven-county metropolitan area. The appointment by
the minority leader must ensure that this requirement for geographic diversity in appointments
is met;
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 Medical Association;
new text end

new text begin (5) one member representing opioid treatment programs, sober living programs, or
substance use disorder programs licensed under chapter 245G;
new text end

new text begin (6) one member appointed by the Minnesota Society of Addiction Medicine who is an
addiction psychiatrist;
new text end

new text begin (7) one member representing professionals providing alternative pain management
therapies, including, but not limited to, acupuncture, chiropractic, or massage therapy;
new text end

new text begin (8) one member representing nonprofit organizations conducting initiatives to address
the opioid epidemic, with the commissioner's initial appointment being a member
representing the Steve Rummler Hope Network, and subsequent appointments representing
this or other organizations;
new text end

new text begin (9) one member appointed by the Minnesota Ambulance Association, who is serving
with an ambulance service as an emergency medical technician, advanced emergency
medical technician, or paramedic;
new text end

new text begin (10) one member representing the Minnesota courts who is a judge or law enforcement
officer;
new text end

new text begin (11) one public member who is a Minnesota resident and who is in opioid addiction
recovery;
new text end

new text begin (12) two members representing Indian tribes, one representing the Ojibwe tribes and
one representing the Dakota tribes;
new text end

new text begin (13) one public member who is a Minnesota resident and who is suffering from chronic
pain, intractable pain, or a rare disease or condition;
new text end

new text begin (14) one mental health advocate representing persons with mental illness;
new text end

new text begin (15) one member representing the Minnesota Hospital Association;
new text end

new text begin (16) one member representing a local health department; and
new text end

new text begin (17) the commissioners of human services, health, and corrections, or their designees,
who shall be ex officio nonvoting members of the council.
new text end

new text begin (b) The commissioner of human services shall coordinate the commissioner's
appointments to provide geographic, racial, and gender diversity, and shall ensure that at
least one-half of council members appointed by the commissioner reside outside of the
seven-county metropolitan area. Of the members appointed by the commissioner, to the
extent practicable, at least one member must represent a community of color
disproportionately affected by the opioid epidemic.
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,
refrain from participating in discussions, 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 epidemic response 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, 2020.
new text end

new text begin (b) The commissioner of human services shall award grants from the opiate epidemic
response account under section 256.043. The grants shall be awarded to proposals selected
by the advisory council that address the priorities in subdivision 1, paragraph (a), clauses
(1) to (4), 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 31 of each year, beginning January 31, 2021. The
report shall include information about the individual projects that receive grants and the
overall role of the project 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 evaluations 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
Epidemic Response Advisory Council, shall report to the chairs and ranking minority
members of the legislative committees with jurisdiction over health and human services
policy and finance when an evaluation study described in subdivision 1, paragraph (c), is
complete 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 the statewide results that the grant project
demonstrated.
new text end

new text begin (c) The advisory council, in its annual report to the legislature under paragraph (a) due
by January 31, 2024, shall include recommendations on whether the appropriations to the
specified entities under this act should be continued, adjusted, or discontinued; whether
funding should be appropriated for other purposes related to opioid abuse prevention,
education, and treatment; and on the appropriate level of funding for existing and new uses.
new text end

Sec. 8.

new text begin [256.043] OPIATE EPIDEMIC RESPONSE ACCOUNT.
new text end

new text begin Subdivision 1. new text end

new text begin Establishment. new text end

new text begin The opiate epidemic response account is established in
the special revenue fund in the state treasury. The registration fees assessed by the Board
of Pharmacy under section 151.066 and the license fees identified in section 151.065,
subdivision 7, paragraphs (b) and (c), shall be deposited into the account. Beginning in
fiscal year 2021, the funds in the account are appropriated each fiscal year to the
commissioner of human services, unless otherwise specified in law.
new text end

new text begin Subd. 2. new text end

new text begin Transfers from account to state agencies. new text end

new text begin (a) Beginning in fiscal year 2021,
the commissioner of human services shall transfer the following amounts each fiscal year
from the account to the agencies specified in this subdivision.
new text end

new text begin (b) $126,000 to the Board of Pharmacy for the collection of the registration fees under
section 151.066.
new text end

new text begin (c) $672,000 to the commissioner of public safety for the Bureau of Criminal
Apprehension. Of this amount, $384,000 is for drug scientists and lab supplies and $288,000
is for special agent positions focused on drug interdiction and drug trafficking.
new text end

new text begin Subd. 3. new text end

new text begin Appropriations from account. new text end

new text begin (a) After the transfers described in subdivision
2, and the appropriations in article 3, section 1, paragraphs (e), (f), (g), and (h) are made,
$249,000 shall be allocated by the commissioner for the provision of administrative services
to the Opiate Epidemic Response Advisory Council and for the administration of the grants
awarded under paragraph (c).
new text end

new text begin (b) After the transfers in subdivision 2 and the allocation of funds in paragraph (a) are
made, 50 percent of the remaining amount shall be distributed by the commissioner to
county social service and tribal 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 and tribal social service agencies based on out-of-home
placement episodes where parental drug abuse is the primary reason for the out-of-home
placement using data from the previous calendar year. County and tribal social service
agencies receiving funds from the opiate epidemic response account must annually report
to the commissioner on how the funds were used to provide child protection services,
including measurable outcomes, as determined by the commissioner. County social service
agencies and tribal social service agencies must not use funds received under this paragraph
to supplant current state or local funding received for child protection services for children
and families who are affected by addiction.
new text end

new text begin (c) After making the transfers in subdivision 2 and the allocation of funds in paragraphs
(a) and (b), the commissioner shall award grants as specified by the Opiate Epidemic
Response Advisory Council in accordance with section 256.042, unless otherwise
appropriated by the legislature.
new text end

new text begin Subd. 4. new text end

new text begin Settlement; sunset. new text end

new text begin (a) If the state receives a total sum of $250,000,000 either
as a result of a settlement agreement or an assurance of discontinuance entered into by the
attorney general of the state, or resulting from a court order in litigation brought by the
attorney general of the state on behalf of the state or a state agency, against one or more
opioid manufacturers or opioid wholesale drug distributors related to alleged violations of
consumer fraud laws in the marketing, sale, or distribution of opioids in this state, or other
alleged illegal actions that contributed to the excessive use of opioids, or from the fees
collected under section 151.065, subdivisions 1 and 3, and section 151.066, that are deposited
into the opiate epidemic response account established in section 256.043, or from a
combination of both, the fees specified in section 151.065, subdivision 1, clause (16), and
section 151.065, subdivision 3, clause (14), shall be reduced to $5,260, and the opiate
registration fee in section 151.066, subdivision 3, shall be repealed.
new text end

new text begin (b) The commissioner of management and budget shall inform the board of pharmacy,
the governor, and the legislature when the amount specified in paragraph (a) has been
reached. The board shall apply the reduced license fee for the next licensure period.
new text end

new text begin (c) Notwithstanding paragraph (a), the reduction of the license fee in section 151.065,
subdivisions 1 and 3, and the repeal of the registration fee in section 151.066 shall not occur
before July 1, 2024.
new text end

Sec. 9. new text begin OPIATE EPIDEMIC RESPONSE ADVISORY COUNCIL FIRST MEETING.
new text end

new text begin The commissioner of human services shall convene the first meeting of the Opiate
Epidemic Response Advisory Council established under Minnesota Statutes, section 256.042,
no later than October 1, 2019. The members shall elect a chair at the first meeting.
new text end

Sec. 10. new text begin REVISOR INSTRUCTION.
new text end

new text begin The fee increases in Minnesota Statutes, section 151.065, subdivisions 1 and 3 in this
act are in addition to any other fee increases in Minnesota Statutes, section 151.065,
subdivisions 1 and 3, enacted in 2019 regular or special sessions. If multiple fees are enacted,
the revisor of statutes shall add the fees together for publication in the 2020 Minnesota
Statutes Supplement to effectuate the intent of the legislature.
new text end

ARTICLE 2

OTHER PROVISIONS

Section 1.

Minnesota Statutes 2018, section 145C.05, subdivision 2, is amended to read:

Subd. 2.

Provisions that may be included.

(a) A health care directive may include
provisions consistent with this chapter, including, but not limited to:

(1) the designation of one or more alternate health care agents to act if the named health
care agent is not reasonably available to serve;

(2) directions to joint health care agents regarding the process or standards by which the
health care agents are to reach a health care decision for the principal, and a statement
whether joint health care agents may act independently of one another;

(3) limitations, if any, on the right of the health care agent or any alternate health care
agents to receive, review, obtain copies of, and consent to the disclosure of the principal's
medical records or to visit the principal when the principal is a patient in a health care
facility;

(4) limitations, if any, on the nomination of the health care agent as guardian for purposes
of sections 524.5-202, 524.5-211, 524.5-302, and 524.5-303;

(5) a document of gift for the purpose of making an anatomical gift, as set forth in chapter
525A, or an amendment to, revocation of, or refusal to make an anatomical gift;

(6) a declaration regarding intrusive mental health treatment under section 253B.03,
subdivision 6d, or a statement that the health care agent is authorized to give consent for
the principal under section 253B.04, subdivision 1a;

(7) a funeral directive as provided in section 149A.80, subdivision 2;

(8) limitations, if any, to the effect of dissolution or annulment of marriage or termination
of domestic partnership on the appointment of a health care agent under section 145C.09,
subdivision 2;

(9) specific reasons why a principal wants a health care provider or an employee of a
health care provider attending the principal to be eligible to act as the principal's health care
agent;

(10) health care instructions by a woman of child bearing age regarding how she would
like her pregnancy, if any, to affect health care decisions made on her behalf; deleted text begin and
deleted text end

(11) health care instructions regarding artificially administered nutrition or hydration deleted text begin . deleted text end new text begin ;
and
new text end

new text begin (12) health care instructions to prohibit administering, dispensing, or prescribing an
opioid, except that these instructions must not be construed to limit the administering,
dispensing, or prescribing an opioid to treat substance abuse, opioid dependence, or an
overdose, unless otherwise prohibited in the health care directive.
new text end

(b) A health care directive may include a statement of the circumstances under which
the directive becomes effective other than upon the judgment of the principal's attending
physician in the following situations:

(1) a principal who in good faith generally selects and depends upon spiritual means or
prayer for the treatment or care of disease or remedial care and does not have an attending
physician, may include a statement appointing an individual who may determine the
principal's decision-making capacity; and

(2) a principal who in good faith does not generally select a physician or a health care
facility for the principal's health care needs may include a statement appointing an individual
who may determine the principal's decision-making capacity, provided that if the need to
determine the principal's capacity arises when the principal is receiving care under the
direction of an attending physician in a health care facility, the determination must be made
by an attending physician after consultation with the appointed individual.

If a person appointed under clause (1) or (2) is not reasonably available and the principal
is receiving care under the direction of an attending physician in a health care facility, an
attending physician shall determine the principal's decision-making capacity.

(c) A health care directive may authorize a health care agent to make health care decisions
for a principal even though the principal retains decision-making capacity.

Sec. 2.

new text begin [145C.17] OPIOID INSTRUCTIONS ENTERED INTO HEALTH RECORD.
new text end

new text begin At the request of the patient or health care agent, a health care provider shall enter into
the patient's health care record any instructions relating to administering, dispensing, or
prescribing an opioid.
new text end

Sec. 3.

Minnesota Statutes 2018, section 151.01, subdivision 27, is amended to read:

Subd. 27.

Practice of pharmacy.

"Practice of pharmacy" means:

(1) interpretation and evaluation of prescription drug orders;

(2) compounding, labeling, and dispensing drugs and devices (except labeling by a
manufacturer or packager of nonprescription drugs or commercially packaged legend drugs
and devices);

(3) participation in clinical interpretations and monitoring of drug therapy for assurance
of safe and effective use of drugs, including the performance of laboratory tests that are
waived under the federal Clinical Laboratory Improvement Act of 1988, United States Code,
title 42, section 263a et seq., provided that a pharmacist may interpret the results of laboratory
tests but may modify drug therapy only pursuant to a protocol or collaborative practice
agreement;

(4) participation in drug and therapeutic device selection; drug administration for first
dosage and medical emergencies; new text begin intramuscular and subcutaneous administration used for
the treatment of alcohol or opioid dependence; new text end drug regimen reviews; and drug or
drug-related research;

new text begin (5) drug administration, through intramuscular and subcutaneous administration used
to treat mental illnesses as permitted under the following conditions:
new text end

new text begin (i) upon the order of a prescriber and the prescriber is notified after administration is
complete; or
new text end

new text begin (ii) pursuant to a protocol or collaborative practice agreement as defined by section
151.01, subdivisions 27b and 27c, and participation in the initiation, management,
modification, administration, and discontinuation of drug therapy is according to the protocol
or collaborative practice agreement between the pharmacist and a dentist, optometrist,
physician, podiatrist, or veterinarian, or an advanced practice registered nurse authorized
to prescribe, dispense, and administer under section 148.235. Any changes in drug therapy
or medication administration made pursuant to a protocol or collaborative practice agreement
must be documented by the pharmacist in the patient's medical record or reported by the
pharmacist to a practitioner responsible for the patient's care;
new text end

deleted text begin (5) deleted text end new text begin (6) new text end participation in administration of influenza vaccines to all eligible individuals
six years of age and older and all other vaccines to patients 13 years of age and older by
written protocol with a physician licensed under chapter 147, a physician assistant authorized
to prescribe drugs under chapter 147A, or an advanced practice registered nurse authorized
to prescribe drugs under section 148.235, provided that:

(i) the protocol includes, at a minimum:

(A) the name, dose, and route of each vaccine that may be given;

(B) the patient population for whom the vaccine may be given;

(C) contraindications and precautions to the vaccine;

(D) the procedure for handling an adverse reaction;

(E) the name, signature, and address of the physician, physician assistant, or advanced
practice registered nurse;

(F) a telephone number at which the physician, physician assistant, or advanced practice
registered nurse can be contacted; and

(G) the date and time period for which the protocol is valid;

(ii) the pharmacist has successfully completed a program approved by the Accreditation
Council for Pharmacy Education specifically for the administration of immunizations or a
program approved by the board;

(iii) the pharmacist utilizes the Minnesota Immunization Information Connection to
assess the immunization status of individuals prior to the administration of vaccines, except
when administering influenza vaccines to individuals age nine and older;

(iv) the pharmacist reports the administration of the immunization to the Minnesota
Immunization Information Connection; and

(v) the pharmacist complies with guidelines for vaccines and immunizations established
by the federal Advisory Committee on Immunization Practices, except that a pharmacist
does not need to comply with those portions of the guidelines that establish immunization
schedules when administering a vaccine pursuant to a valid, patient-specific order issued
by a physician licensed under chapter 147, a physician assistant authorized to prescribe
drugs under chapter 147A, or an advanced practice nurse authorized to prescribe drugs
under section 148.235, provided that the order is consistent with the United States Food
and Drug Administration approved labeling of the vaccine;

deleted text begin (6) deleted text end new text begin (7) new text end participation in the initiation, management, modification, and discontinuation of
drug therapy according to a written protocol or collaborative practice agreement between:
(i) one or more pharmacists and one or more dentists, optometrists, physicians, podiatrists,
or veterinarians; or (ii) one or more pharmacists and one or more physician assistants
authorized to prescribe, dispense, and administer under chapter 147A, or advanced practice
nurses authorized to prescribe, dispense, and administer under section 148.235. Any changes
in drug therapy made pursuant to a protocol or collaborative practice agreement must be
documented by the pharmacist in the patient's medical record or reported by the pharmacist
to a practitioner responsible for the patient's care;

deleted text begin (7) deleted text end new text begin (8) new text end participation in the storage of drugs and the maintenance of records;

deleted text begin (8) deleted text end new text begin (9) new text end patient counseling on therapeutic values, content, hazards, and uses of drugs and
devices;

deleted text begin (9) deleted text end new text begin (10) new text end offering or performing those acts, services, operations, or transactions necessary
in the conduct, operation, management, and control of a pharmacy; and

deleted text begin (10) deleted text end new text begin (11) new text end participation in the initiation, management, modification, and discontinuation
of therapy with opiate antagonists, as defined in section 604A.04, subdivision 1, pursuant
to:

(i) a written protocol as allowed under clause (6); or

(ii) a written protocol with a community health board medical consultant or a practitioner
designated by the commissioner of health, as allowed under section 151.37, subdivision 13.

Sec. 4.

Minnesota Statutes 2018, section 151.37, subdivision 12, is amended to read:

Subd. 12.

Administration of opiate antagonists for drug overdose.

(a) A licensed
physician, a licensed advanced practice registered nurse authorized to prescribe drugs
pursuant to section 148.235, or a licensed physician assistant authorized to prescribe drugs
pursuant to section 147A.18 may authorize the following individuals to administer opiate
antagonists, as defined in section 604A.04, subdivision 1:

(1) an emergency medical responder registered pursuant to section 144E.27;

(2) a peace officer as defined in section 626.84, subdivision 1, paragraphs (c) and (d);
deleted text begin and
deleted text end

(3) new text begin correctional employees of a state or local political subdivision;
new text end

new text begin (4) new text end staff of community-based health disease prevention or social service programs new text begin ;
new text end

new text begin (5) a volunteer firefighter; and
new text end

new text begin (6) a licensed school nurse or certified public health nurse employed by, or under contract
with, a school board under section 121A.21 new text end .

(b) For the purposes of this subdivision, opiate antagonists may be administered by one
of these individuals only if:

(1) the licensed physician, licensed physician assistant, or licensed advanced practice
registered nurse has issued a standing order to, or entered into a protocol with, the individual;
and

(2) the individual has training in the recognition of signs of opiate overdose and the use
of opiate antagonists as part of the emergency response to opiate overdose.

(c) Nothing in this section prohibits the possession and administration of naloxone
pursuant to section 604A.04.

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 2018, section 152.105, subdivision 2, is amended to read:

Subd. 2.

Sheriff to maintain collection receptacle.

new text begin (a) new text end The sheriff of each county shall
maintain or contract for the maintenance of at least one collection receptacle for the disposal
of noncontrolled substances, pharmaceutical controlled substances, and other legend drugs,
as permitted by federal law. For purposes of this section, "legend drug" has the meaning
given in section 151.01, subdivision 17. The collection receptacle must comply with federal
law. In maintaining and operating the collection receptacle, the sheriff shall follow all
applicable provisions of Code of Federal Regulations, title 21, parts 1300, 1301, 1304, 1305,
1307, and 1317, as amended through May 1, 2017.

new text begin (b) A sheriff may meet the requirements of paragraph (a) by providing public educational
information and making an alternative method available to the public, at no charge, for
safely destroying unwanted legend drugs, including an at-home prescription drug deactivation
and disposal product, so long as the alternative method meets the requirements of the
Minnesota Pollution Control Agency, the United States Drug Enforcement Administration,
and the Board of Pharmacy.
new text end

Sec. 6.

Minnesota Statutes 2018, 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 may be initially dispensed more than 30 days after the date on which
the prescription was issued. No subsequent refills indicated on a prescription for a Schedule
III or IV opiate or narcotic pain reliever may be dispensed more than 30 days after the
previous date on which the prescription was initially filled or refilled. After the authorized
refills for Schedule III or IV opiate or narcotic pain relievers have been used up or are
expired, 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. 7.

Minnesota Statutes 2018, section 152.11, subdivision 2d, is amended to read:

Subd. 2d.

Identification requirement for deleted text begin Schedule II or III deleted text end controlled substance
prescriptions.

deleted text begin (a) deleted text end No person may dispense a controlled substance included in deleted text begin Schedule II
or III deleted text end new text begin Schedules II through V new text end without requiring the person purchasing the controlled
substance, who need not be the deleted text begin person deleted text end new text begin patient new text end for whom the controlled substance prescription
is written, to present valid photographic identification, unless the person purchasing the
controlled substance deleted text begin , or if applicable the person for whom the controlled substance
prescription is written, deleted text end is known to the dispenser. new text begin A doctor of veterinary medicine who
dispenses a controlled substance must comply with this subdivision.
new text end

deleted text begin (b) This subdivision applies only to purchases of controlled substances that are not
covered, in whole or in part, by a health plan company or other third-party payor.
deleted text end

Sec. 8.

Minnesota Statutes 2018, section 152.11, 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 new text begin ,
including acute pain associated with wisdom teeth extraction surgery new text end 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

new text begin (d) Notwithstanding paragraph (a) or (b), if, in the professional clinical judgment of a
practitioner, more than the limit specified in paragraph (a) or (b) is required to treat a patient's
acute pain, the practitioner may issue a prescription for the quantity needed to treat the
patient's acute pain.
new text end

Sec. 9.

Minnesota Statutes 2018, 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, 2021, 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:
new text end

new text begin (1) before the prescriber issues an initial prescription order for a Schedules II through
IV opiate controlled substance to the patient; and
new text end

new text begin (2) at least once every three months for patients receiving an opiate for treatment of
chronic pain or participating in medically assisted treatment for an opioid addiction.
new text end

new text begin (e) Paragraph (d) does not apply if:
new text end

new text begin (1) the patient is receiving palliative care, or hospice or other end-of-life care;
new text end

new text begin (2) the patient is being treated for pain due to cancer or the treatment of cancer;
new text end

new text begin (3) 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 (4) the prescriber and patient have a current or ongoing provider/patient relationship of
a duration longer than one year;
new text end

new text begin (5) the prescription order is issued within 14 days following surgery or three days
following oral surgery or follows the prescribing protocols established under the opioid
prescribing improvement program under section 256B.0638;
new text end

new text begin (6) the controlled substance is prescribed or administered to a patient who is admitted
to an inpatient hospital;
new text end

new text begin (7) 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 (8) due to a medical 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 (9) 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 (f) 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 (g) 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 (h) 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 (i) 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 (j) 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 (k) 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 (l) 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. 10.

Minnesota Statutes 2018, section 214.12, is amended by adding a subdivision to
read:

new text begin Subd. 6. new text end

new text begin Opioid and controlled substances prescribing. new text end

new text begin (a) The Board of Medical
Practice, the Board of Nursing, the Board of Dentistry, the Board of Optometry, and the
Board of Podiatric Medicine shall require that licensees with the authority to prescribe
controlled substances obtain at least two hours of continuing education credit on best practices
in prescribing opioids and controlled substances, including nonpharmacological and
implantable device alternatives for treatment of pain and ongoing pain management, as part
of the continuing education requirements for licensure renewal. Licensees shall not be
required to complete more than two credit hours of continuing education on best practices
in prescribing opioids and controlled substances before this subdivision expires. Continuing
education credit on best practices in prescribing opioids and controlled substances must
meet board requirements.
new text end

new text begin (b) Paragraph (a) does not apply to any licensee who is participating in the opioid
prescribing improvement program under section 256B.0638, unless the licensee has been
terminated as a medical assistance provider under section 256B.0638, subdivision 5,
paragraph (d).
new text end

new text begin (c) This subdivision expires January 1, 2023.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2020.
new text end

ARTICLE 3

APPROPRIATIONS

Section 1. new text begin APPROPRIATIONS.
new text end

new text begin (a) Board of Pharmacy; administration. $244,000 in fiscal year 2020 is appropriated
from the general fund to the Board of Pharmacy for onetime information technology and
operating costs for administration of licensing activities under Minnesota Statutes, section
151.066. This is a onetime appropriation.
new text end

new text begin (b) Commissioner of human services; administration. $309,000 in fiscal year 2020
is appropriated from the general fund and $60,000 in fiscal year 2021 is appropriated from
the opiate epidemic response account to the commissioner of human services for the provision
of administrative services to the Opiate Epidemic Response Advisory Council and for the
administration of the grants awarded under paragraphs (f), (g), and (h). The opiate epidemic
response account base for this appropriation is $60,000 in fiscal year 2022, $60,000 in fiscal
year 2023, $60,000 in fiscal year 2024, and $0 in fiscal year 2025.
new text end

new text begin (c) Board of Pharmacy; administration. $126,000 in fiscal year 2020 is appropriated
from the general fund to the Board of Pharmacy for the collection of the registration fees
under section 151.066.
new text end

new text begin (d) Commissioner of public safety; enforcement activities. $672,000 in fiscal year
2020 is appropriated from the general fund to the commissioner of public safety for the
Bureau of Criminal Apprehension. Of this amount, $384,000 is for drug scientists and lab
supplies and $288,000 is for special agent positions focused on drug interdiction and drug
trafficking.
new text end

new text begin (e) Commissioner of management and budget; evaluation activities. $300,000 in
fiscal year 2020 is appropriated from the general fund and $300,000 in fiscal year 2021 is
appropriated from the opiate epidemic response account to the commissioner of management
and budget for evaluation activities under Minnesota Statutes, section 256.042, subdivision
1, paragraph (c). The opiate epidemic response account base for this appropriation is $300,000
in fiscal year 2022, $300,000 in fiscal year 2023, $300,000 in fiscal year 2024, and $0 in
fiscal year 2025.
new text end

new text begin (f) Commissioner of human services; grants for Project ECHO. $400,000 in fiscal
year 2020 is appropriated from the general fund and $400,000 in fiscal year 2021 is
appropriated from the opiate epidemic response account to the commissioner of human
services for grants of $200,000 to CHI St. Gabriel's Health Family Medical Center for the
opioid-focused Project ECHO program and $200,000 to Hennepin Health Care for the
opioid-focused Project ECHO program. The opiate epidemic response account base for this
appropriation is $400,000 in fiscal year 2022, $400,000 in fiscal year 2023, $400,000 in
fiscal year 2024, and $0 in fiscal year 2025.
new text end

new text begin (g) Commissioner of human services; opioid overdose prevention grant. $100,000
in fiscal year 2020 is appropriated from the general fund and $100,000 in fiscal year 2021
is appropriated from the opiate epidemic response account to the commissioner of human
services for a grant to a nonprofit organization that has provided overdose prevention
programs to the public in at least 60 counties within the state, for at least three years, has
received federal funding before January 1, 2019, and is dedicated to addressing the opioid
epidemic. The grant must be used for opioid overdose prevention, community asset mapping,
education, and overdose antagonist distribution. The opiate epidemic response account base
for this appropriation is $100,000 in fiscal year 2022, $100,000 in fiscal year 2023, $100,000
in fiscal year 2024, and $0 in fiscal year 2025.
new text end

new text begin (h) Commissioner of human services; traditional healing. $2,000,000 in fiscal year
2020 is appropriated from the general fund and $2,000,000 in fiscal year 2021 is appropriated
from the opiate epidemic response account to the commissioner of human services to award
grants to tribal nations and five urban Indian communities for traditional healing practices
to American Indians and to increase the capacity of culturally specific providers in the
behavioral health workforce. The opiate epidemic response account base for this appropriation
is $2,000,000 in fiscal year 2022, $2,000,000 in fiscal year 2023, $2,000,000 in fiscal year
2024, and $0 in fiscal year 2025.
new text end

new text begin (i) Board of Dentistry; continuing education. $11,000 in fiscal year 2020 is
appropriated from the state government special revenue fund to the Board of Dentistry to
implement the continuing education requirements under Minnesota Statutes, section 214.12,
subdivision 6.
new text end

new text begin (j) Board of Medical Practice; continuing education. $17,000 in fiscal year 2020 is
appropriated from the state government special revenue fund to the Board of Medical Practice
to implement the continuing education requirements under Minnesota Statutes, section
214.12, subdivision 6.
new text end

new text begin (k) Board of Nursing; continuing education. $17,000 in fiscal year 2020 is appropriated
from the state government special revenue fund to the Board of Nursing to implement the
continuing education requirements under Minnesota Statutes, section 214.12, subdivision
6.
new text end

new text begin (l) Board of Optometry; continuing education. $5,000 in fiscal year 2020 is
appropriated from the state government special revenue fund to the Board of Optometry to
implement the continuing education requirements under Minnesota Statutes, section 214.12,
subdivision 6.
new text end

new text begin (m) Board of Podiatric Medicine; continuing education. $5,000 in fiscal year 2020
is appropriated from the state government special revenue fund to the Board of Podiatric
Medicine to implement the continuing education requirements under Minnesota Statutes,
section 214.12, subdivision 6.
new text end

new text begin (n) Commissioner of health; nonnarcotic pain management and wellness. $1,250,000
is appropriated in fiscal year 2020 from the general fund to the commissioner of health, to
provide funding for:
new text end

new text begin (1) statewide mapping and assessment of community-based nonnarcotic pain management
and wellness resources; and
new text end

new text begin (2) up to five demonstration projects in different geographic areas of the state to provide
community-based nonnarcotic pain management and wellness resources to patients and
consumers.
new text end

new text begin The demonstration projects must include an evaluation component and scalability analysis.
The commissioner shall award the grant for the statewide mapping and assessment, and the
demonstration project grants, through a competitive request for proposal process. Grants
for statewide mapping and assessment and demonstration projects may be awarded
simultaneously. In awarding demonstration project grants, the commissioner shall give
preference to proposals that incorporate innovative community partnerships, are informed
and led by people in the community where the project is taking place, and are culturally
relevant and delivered by culturally competent providers. This is a onetime appropriation.
new text end

new text begin (o) Commissioner of health; administration. $38,000 in fiscal year 2020 is appropriated
from the general fund to the commissioner of health for the administration of the grants
awarded in paragraph (n).
new text end

Sec. 2. new text begin TRANSFER.
new text end

new text begin By June 30, 2021, the commissioner of human services shall transfer $5,439,000 from
the opiate epidemic response account to the general fund. This is a onetime transfer.
new text end

Sec. 3. new text begin EXPIRATION OF UNCODIFIED LANGUAGE.
new text end

new text begin The uncodified language in this article shall not expire on June 30, 2021.
new text end