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Minnesota Legislature

Office of the Revisor of Statutes

HF 400

as introduced - 91st Legislature (2019 - 2020) Posted on 01/28/2019 01:57pm

KEY: stricken = removed, old language.
underscored = added, new language.
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A bill for an act
relating to health; establishing the Opioid Stewardship Advisory Council;
establishing the opioid stewardship account; establishing an opiate product
registration fee; modifying provisions related to opioid addiction prevention,
education, intervention, treatment, and recovery; appropriating money; requiring
reports; amending Minnesota Statutes 2018, sections 120B.021, subdivision 1;
145.9269, subdivision 1; 151.252, subdivision 1; 151.37, subdivision 12; 151.47,
by adding a subdivision; 151.71, by adding a subdivision; 152.105, subdivision
2; 152.11, subdivision 2d, by adding a subdivision; 214.12, by adding subdivisions;
proposing coding for new law in Minnesota Statutes, chapters 62Q; 120B; 145;
151; proposing coding for new law as Minnesota Statutes, chapter 62W.

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

ARTICLE 1

OPIOID PRODUCT STEWARDSHIP

Section 1.

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), 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, 2020. 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 endnew 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 endnew 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 endnew 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 endnew 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 endnew 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 endnew 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.

new text begin [151.255] OPIOID STEWARDSHIP ADVISORY COUNCIL.
new text end

new text begin Subdivision 1. new text end

new text begin Establishment of advisory council. new text end

new text begin (a) The Opioid Stewardship Advisory
Council is established to confront the opioid addiction and overdose epidemic in this state
and focus on:
new text end

new text begin (1) prevention and education, including public education and awareness for adults and
youth, prescriber education, and the development and sustainability of substance use disorder
programs;
new text end

new text begin (2) the expansion and enhancement of a continuum of care for opioid-related substance
use disorders, including primary prevention, early intervention, treatment, and recovery
services;
new text end

new text begin (3) training on the treatment of opioid addiction, including the use of all FDA-approved
opioid addiction medications, detoxification, relapse prevention, patient assessment,
individual treatment planning, counseling, recovery supports, diversion control, and other
best practices; and
new text end

new text begin (4) services to ensure overdose prevention as well as public safety and community
well-being, including expanding access to FDA-approved opioid addiction medications and
providing social services to families affected by the opioid overdose epidemic.
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, and services for individuals and families experiencing and affected by opioid
addiction;
new text end

new text begin (2) establish priorities and actions to address the state's opioid epidemic for the purpose
of allocating funds;
new text end

new text begin (3) ensure available funding is aligned with existing state and federal funding to achieve
the greatest impact and ensure a coordinated state effort;
new text end

new text begin (4) develop criteria and procedures to be used in awarding grants and allocating available
funds from the opioid stewardship account; and
new text end

new text begin (5) develop measurable outcomes to determine the effectiveness of the funds allocated.
new text end

new text begin (c) The council shall make recommendations on grant and funding options for the funds
annually appropriated to the commissioner of human services from the opioid stewardship
account. The options for funding may include but are not limited to: prescriber education;
the development and sustainability of prevention programs; the creation of a continuum of
care for opioid-related substance abuse disorders, including primary prevention, early
intervention, treatment, and recovery services; and additional funding for child protection
case management services for children and families affected by opioid addiction. The council
shall submit recommendations for funding options to the commissioner of human services
and 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 Subd. 2. new text end

new text begin Membership. new text end

new text begin (a) The council shall consist of 20 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 of the house of representatives;
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 medical doctor appointed by the Minnesota chapter of the
American College of Emergency Physicians;
new text end

new text begin (5) one member representing programs licensed under chapter 245G that specialize in
serving people with opioid use disorders;
new text end

new text begin (6) one member representing the National Alliance on Mental Illness (NAMI);
new text end

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

new text begin (8) one member representing professionals providing alternative pain management
therapies;
new text end

new text begin (9) the commissioner of education or a designee;
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 member representing the Minnesota Hospital Association;
new text end

new text begin (12) one member representing an Indian tribe;
new text end

new text begin (13) the commissioner of human services or a designee;
new text end

new text begin (14) the commissioner of corrections or a designee;
new text end

new text begin (15) one advanced practice registered nurse appointed by the Board of Nursing;
new text end

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

new text begin (17) one member representing a local health department; and
new text end

new text begin (18) one member with personal experience of opioid addiction, representing a nonprofit
entity specializing in providing support to persons recovering from substance use disorder.
new text end

new text begin (b) The commissioner 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 semiannually 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

Sec. 3.

new text begin [151.256] OPIOID STEWARDSHIP ACCOUNT.
new text end

new text begin Subdivision 1. new text end

new text begin Establishment. new text end

new text begin The opioid 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. All state appropriations
to the account, and any federal funds or grant dollars received for the prevention and
treatment of opioid addiction, 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) For fiscal year 2020, money in the account is
appropriated as specified in article 6.
new text end

new text begin (b) For fiscal year 2021 and subsequent fiscal years, money in the opioid stewardship
account is appropriated to the commissioner of human services, to be awarded, in consultation
with the Opioid Stewardship Advisory Council, as grants or as other funding as determined
appropriate to address the opioid epidemic in the state. Each recipient of grants or funding
shall report to the commissioner and the advisory council on how the funds were spent and
the outcomes achieved, in the form and manner specified by the commissioner.
new text end

new text begin Subd. 3. new text end

new text begin Annual report. new text end

new text begin Beginning January 15, 2020, and each January 15 thereafter,
the commissioner, in consultation with the Opioid Stewardship 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 on the grants and funds
awarded under this section and article 6 and the outcomes achieved. Each report must also
identify those instances for which the commissioner did not follow the recommendations
of the advisory council and the commissioner's rationale for taking this action.
new text end

Sec. 4.

Minnesota Statutes 2018, 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, subdivision 4, by June 1 of each year beginning June 1, 2020.
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, subdivision 4, that the original owner
would have been assessed had it retained ownership.
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 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,
2020, 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 or wholesaler 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, 2020, each owner of a pharmacy with
at least one location 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, 2020, 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, and notwithstanding section
152.126, subdivision 6, 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, 2020, the board shall notify each
wholesaler of 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, and notwithstanding section
152.126, subdivision 6, 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 151.47, subdivision 1a. 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 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 2020, 2021, and 2022, 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, 2023.
new text end

new text begin Subd. 6. new text end

new text begin Legislative review. new text end

new text begin The legislature shall review the reports from the Opioid
Stewardship Advisory Council under section 151.255, subdivision 1, paragraph (c), 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 assessed under this section should continue beyond July
1, 2023.
new text end

Sec. 6. new text beginADVISORY COUNCIL FIRST MEETING.
new text end

new text begin The commissioner of human services shall convene the first meeting of the Opioid
Stewardship Advisory Council established under Minnesota Statutes, section 151.255, no
later than October 1, 2019. The members shall elect a chair at the first meeting.
new text end

ARTICLE 2

HEALTH PLAN COMPANY REQUIREMENTS

Section 1.

new text begin [62Q.528] COVERAGE FOR PAIN MANAGEMENT SERVICES.
new text end

new text begin All health plans must cover acupuncture services for the treatment of pain and ongoing
pain management when those services are performed by an individual who is licensed as:
new text end

new text begin (1) new text end new text begin an acupuncture practitioner under chapter 147B; or
new text end

new text begin (2) a chiropractor under chapter 148.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2020, and applies to health
plans offered, issued, or renewed to a Minnesota resident on or after that date.
new text end

Sec. 2.

Minnesota Statutes 2018, section 151.71, is amended by adding a subdivision to
read:


new text begin Subd. 3. new text end

new text begin Lowest cost to consumers. new text end

new text begin (a) A health plan company or pharmacy benefits
manager shall not require an individual to make a payment at the point of sale for a covered
prescription medication in an amount greater than the allowable cost to consumers, as
defined in paragraph (b).
new text end

new text begin (b) For purposes of paragraph (a), "allowable cost to consumers" means the lowest of:
(1) the applicable co-payment for the prescription medication; or (2) the amount an individual
would pay for the prescription medication if the individual purchased the prescription
medication without using a health plan benefit.
new text end

ARTICLE 3

PREVENTION AND EDUCATION

Section 1.

Minnesota Statutes 2018, section 120B.021, subdivision 1, is amended to read:


Subdivision 1.

Required academic standards.

(a) The following subject areas are
required for statewide accountability:

(1) language arts;

(2) mathematics;

(3) science;

(4) social studies, including history, geography, economics, and government and
citizenship that includes civics consistent with section 120B.02, subdivision 3;

(5) physical education;

(6) health, for which locally developed academic standards applynew text begin, consistent with
paragraph (e)
new text end; and

(7) the arts, for which statewide or locally developed academic standards apply, as
determined by the school district. Public elementary and middle schools must offer at least
three and require at least two of the following four arts areas: dance; music; theater; and
visual arts. Public high schools must offer at least three and require at least one of the
following five arts areas: media arts; dance; music; theater; and visual arts.

(b) For purposes of applicable federal law, the academic standards for language arts,
mathematics, and science apply to all public school students, except the very few students
with extreme cognitive or physical impairments for whom an individualized education
program team has determined that the required academic standards are inappropriate. An
individualized education program team that makes this determination must establish
alternative standards.

(c) The department must adopt the most recent SHAPE America (Society of Health and
Physical Educators) kindergarten through grade 12 standards and benchmarks for physical
education as the required physical education academic standards. The department may
modify and adapt the national standards to accommodate state interest. The modification
and adaptations must maintain the purpose and integrity of the national standards. The
department must make available sample assessments, which school districts may use as an
alternative to local assessments, to assess students' mastery of the physical education
standards beginning in the 2018-2019 school year.

(d) A school district may include child sexual abuse prevention instruction in a health
curriculum, consistent with paragraph (a), clause (6). Child sexual abuse prevention
instruction may include age-appropriate instruction on recognizing sexual abuse and assault,
boundary violations, and ways offenders groom or desensitize victims, as well as strategies
to promote disclosure, reduce self-blame, and mobilize bystanders. A school district may
provide instruction under this paragraph in a variety of ways, including at an annual assembly
or classroom presentation. A school district may also provide parents information on the
warning signs of child sexual abuse and available resources.

new text begin (e) A school district must include instruction in a health curriculum for students in grades
5, 6, 8, 10, and 12 on substance misuse prevention, including opioids; controlled substances
as defined in section 152.01, subdivision 4; prescription and nonprescription medications;
and illegal drugs. A school district is not required to use a specific methodology or
curriculum.
new text end

deleted text begin (e)deleted text endnew text begin (f)new text end District efforts to develop, implement, or improve instruction or curriculum as a
result of the provisions of this section must be consistent with sections 120B.10, 120B.11,
and 120B.20.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective for the 2020-2021 school year and later.
new text end

Sec. 2.

new text begin [120B.215] SUBSTANCE MISUSE PREVENTION.
new text end

new text begin School districts and charter schools are encouraged to provide substance misuse
prevention instruction for students in grades 5 through 12 integrated into existing programs,
curriculum, or the general school environment of a district or charter school. The
commissioner of education, in consultation with the director of the Alcohol and Other Drug
Abuse Section under section 254A.03 and substance misuse prevention and treatment
organizations, must, upon request, provide districts and charter schools with:
new text end

new text begin (1) information regarding substance misuse prevention services; and
new text end

new text begin (2) assistance in using Minnesota student survey results to inform prevention programs.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective July 1, 2019.
new text end

Sec. 3.

new text begin [151.72] VOLUNTARY NONOPIOID DIRECTIVE.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section, the following definitions
apply.
new text end

new text begin (b) "Board" means the Board of Pharmacy.
new text end

new text begin (c) "Opioid" means any product containing opium or opiates listed in section 152.02,
subdivision 3, paragraphs (b) and (c); any product containing narcotics listed in section
152.02, subdivision 4, paragraphs (e) and (h); or any product containing narcotic drugs
listed in section 152.02, subdivision 5, paragraph (b), other than products containing
difenoxin or eluxadoline.
new text end

new text begin Subd. 2. new text end

new text begin Execution of directive. new text end

new text begin (a) An individual who is 18 years of age or older or
an emancipated minor, a parent or legal guardian of a minor, or an individual's guardian or
other person appointed by the individual or the court to manage the individual's health care
may execute a voluntary nonopioid directive instructing health care providers that an opioid
may not be administered or prescribed to the individual or the minor. The directive must
be in the format prescribed by the board. The person executing the directive may submit
the directive to a health care provider or hospital.
new text end

new text begin (b) An individual executing a directive may revoke the directive at any time in writing
or orally.
new text end

new text begin Subd. 3. new text end

new text begin Duties of the board. new text end

new text begin The board shall adopt rules establishing guidelines to
govern the use of voluntary nonopioid health care directives. The guidelines must:
new text end

new text begin (1) include verification by a health care provider and comply with the written consent
requirements under United States Code, title 42, section 290dd-2(b);
new text end

new text begin (2) specify standard procedures for the person executing a directive to use when
submitting the directive to a health care provider or hospital;
new text end

new text begin (3) specify procedures to include the directive in the individual's medical record or
interoperable electronic health record, and to submit the directive to the prescription
monitoring program database;
new text end

new text begin (4) specify procedures to modify, override, or revoke a directive;
new text end

new text begin (5) include exemptions for the administration of naloxone or other opioid overdose drugs
in an emergency situation;
new text end

new text begin (6) ensure the confidentiality of a voluntary nonopioid directive; and
new text end

new text begin (7) ensure exemptions for an opioid used to treat substance abuse or opioid dependence.
new text end

new text begin Subd. 4. new text end

new text begin Exemption from liability. new text end

new text begin (a) A health care provider, a hospital, or an employee
of a health care provider or hospital may not be subject to disciplinary action by the health
care provider's or employee's professional licensing board or held civilly or criminally liable
for failure to administer, prescribe, or dispense an opioid, or for inadvertent administration
of an opioid, to an individual or minor who has a voluntary nonopioid directive.
new text end

new text begin (b) A prescription presented to a pharmacy is presumed to be valid, and a pharmacist
may not be subject to disciplinary action by the pharmacist's professional licensing board
or held civilly or criminally liable for dispensing an opioid in contradiction to an individual's
or minor's voluntary nonopioid directive.
new text end

new text begin Subd. 5. new text end

new text begin Construction. new text end

new text begin Nothing in this section shall be construed to:
new text end

new text begin (1) alter a health care directive under chapter 145C;
new text end

new text begin (2) limit the prescribing, dispensing, or administering of an opioid overdose drug; or
new text end

new text begin (3) limit an authorized health care provider or pharmacist from prescribing, dispensing,
or administering an opioid for the treatment of substance abuse or opioid dependence.
new text end

Sec. 4.

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


Subd. 2.

Sheriff to maintain collection receptacle.

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 The sheriff of each county may meet
the requirements of this subdivision through the use of an alternative method for the disposal
of noncontrolled substances, pharmaceutical controlled substances, and other legend drugs
that has been approved by the Board of Pharmacy. This may include making available to
the public, without charge, at-home prescription drug deactivation and disposal products
that render drugs and medications inert and irretrievable.
new text end

Sec. 5.

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


Subd. 2d.

Identification requirement for deleted text beginSchedule II or IIIdeleted text end controlled substance
prescriptions.

deleted text begin(a)deleted text end No person may dispense a controlled substance included in deleted text beginSchedule II
or III
deleted text endnew text begin Schedules II through Vnew text end without requiring the person purchasing the controlled
substance, who need not be the deleted text beginpersondeleted text endnew text begin patientnew text end for whom the controlled substance prescription
is written, to present valid photographic identification, unless the person purchasing the
controlled substancedeleted 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. 6.

Minnesota Statutes 2018, section 152.11, is amended by adding a subdivision to
read:


new text begin Subd. 5. new text end

new text begin Limitations on dispensing of opioid prescription drug orders. new text end

new text begin (a) No
prescription drug order for an opioid drug listed in Schedule II may be dispensed by a
pharmacist or other dispenser more than 30 days after the date on which the prescription
drug order was issued.
new text end

new text begin (b) No prescription drug order for an opioid drug listed in Schedules III through V may
be initially dispensed by a pharmacist or other dispenser more than 30 days after the date
on which the prescription drug order was issued. No prescription drug order for an opioid
drug listed in Schedules III through V may be refilled by a pharmacist or other dispenser
more than 30 days after the previous date on which it was dispensed.
new text end

new text begin (c) For purposes of this section, "dispenser" has the meaning given in section 152.126,
subdivision 1.
new text end

Sec. 7.

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, 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) This subdivision expires January 1, 2024.
new text end

new text begin EFFECTIVE DATE. new text end

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

Sec. 8.

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


new text begin Subd. 7. new text end

new text begin Opioid alternatives. new text end

new text begin The Board of Medical Practice, the Board of Nursing,
and the Board of Dentistry shall require that licensees with the authority to prescribe opioid
medicines receive two hours of continuing education on nonpharmacological alternatives
for treatment of pain and ongoing pain management.
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 4

INTERVENTION, TREATMENT, AND RECOVERY

Section 1.

Minnesota Statutes 2018, section 145.9269, subdivision 1, is amended to read:


Subdivision 1.

Definitions.

For purposes of this sectionnew text begin and section 145.9272new text end, "federally
qualified health center" means an entity that is receiving a grant under United States Code,
title 42, section 254b, or, based on the recommendation of the Health Resources and Services
Administration within the Public Health Service, is determined by the secretary to meet the
requirements for receiving such a grant.

Sec. 2.

new text begin [145.9272] GRANTS FOR OPIOID ADDICTION AND SUBSTANCE USE
DISORDER TREATMENT, RECOVERY, AND PREVENTION PROGRAMS.
new text end

new text begin Subdivision 1. new text end

new text begin Grant program established. new text end

new text begin (a) The commissioner of health shall
distribute grants to qualified entities operating in Minnesota as of January 1, 2019, for
integrated, community-based programs in primary care settings to treat, prevent, and raise
awareness of opioid addiction and substance use disorders.
new text end

new text begin (b) For purposes of this section, a "qualified entity" means a federally qualified health
center, substance use disorder treatment program, or other provider of opioid prevention,
treatment, and recovery services as designated by the commissioner.
new text end

new text begin Subd. 2. new text end

new text begin Grant allocation; allowable uses. new text end

new text begin (a) For each grant cycle, the commissioner
shall allocate grants to qualified entities operating in Minnesota as of January 1, 2019,
through a competitive process. The commissioner shall award grants to qualified entities
to establish new opioid addiction and substance use disorder programs and to expand existing
programs.
new text end

new text begin (b) In awarding grants, the commissioner shall give preference to proposals that expand
access to services for low-income persons, populations at greatest risk of opioid addiction,
or populations or areas of the state that are underserved.
new text end

new text begin Subd. 3. new text end

new text begin Report. new text end

new text begin Each grant recipient shall report to the commissioner, at a time and in
a manner specified by the commissioner, information on the use of grant funding and
outcomes achieved. The commissioner shall compile this information into a report and shall
provide the report to the chairs and ranking minority members of the legislative committees
with jurisdiction over health and human services policy and finance.
new text end

Sec. 3.

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) staff of community-based health disease prevention or social service programsdeleted text begin.deleted text endnew text begin;
new text end

new text begin (4) a probation or supervised release officer; and
new text end

new text begin (5) a volunteer firefighter.
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.

ARTICLE 5

PHARMACY BENEFIT MANAGER LICENSURE

Section 1.

new text begin [62W.01] DEFINITIONS.
new text end

new text begin Subdivision 1. new text end

new text begin Applicability. new text end

new text begin For purposes of this chapter, the following definitions
apply.
new text end

new text begin Subd. 2. new text end

new text begin Commissioner. new text end

new text begin "Commissioner" means the commissioner of commerce.
new text end

new text begin Subd. 3. new text end

new text begin Health plan. new text end

new text begin "Health plan" has the meaning provided in section 62Q.01,
subdivision 3, except that the term also includes a policy, certificate, or contract of health
coverage offered by a self-insured employer.
new text end

new text begin Subd. 4. new text end

new text begin Health plan company. new text end

new text begin "Health plan company" has the meaning provided in
section 62Q.01, subdivision 4.
new text end

new text begin Subd. 5. new text end

new text begin Pharmacy benefit manager. new text end

new text begin "Pharmacy benefit manager" means a person or
entity doing business in this state which contracts to administer prescription drug benefits
on behalf of a health plan company or employer.
new text end

Sec. 2.

new text begin [62W.03] LICENSURE OF PHARMACY BENEFIT MANAGERS.
new text end

new text begin Subdivision 1. new text end

new text begin Requirement to obtain a license. new text end

new text begin (a) Effective January 1, 2020, a
pharmacy benefit manager must obtain a license from the commissioner to conduct business
in this state. To obtain an initial license or to renew a license, a pharmacy benefit manager
shall submit to the commissioner:
new text end

new text begin (1) a nonrefundable licensure fee of $....... or a licensure renewal fee of $......., as
applicable;
new text end

new text begin (2) a copy of the corporate charter, articles of incorporation, or other similar document,
of the applicant or licensee; and
new text end

new text begin (3) a completed licensure form containing:
new text end

new text begin (i) the name and address of the licensee; and
new text end

new text begin (ii) the name, address, and official position of each officer and director of the licensee.
new text end

new text begin (b) The licensee shall report any change in information required by paragraph (a) to the
commissioner in writing within 60 days after the change occurs.
new text end

new text begin Subd. 2. new text end

new text begin Issuance of certificate of licensure. new text end

new text begin Upon receipt of a completed licensure
form, the required documents, and the licensure fee, the commissioner shall issue a certificate
of licensure. The certificate may be in paper or electronic form, and shall clearly indicate
the expiration date of the license. Certificates of licensure are nontransferable. A certificate
of licensure is valid for two years after its date of issue.
new text end

new text begin Subd. 3. new text end

new text begin Disciplinary action. new text end

new text begin When the commissioner finds that a licensee has violated
a requirement of this chapter, the commissioner may do one or more of the following:
new text end

new text begin (1) deny the issuance of a license;
new text end

new text begin (2) refuse to renew a license;
new text end

new text begin (3) revoke or suspend the license; and
new text end

new text begin (4) impose a civil penalty of up to $10,000 for each separate violation.
new text end

ARTICLE 6

APPROPRIATIONS

Section 1. new text beginBUREAU OF CRIMINAL APPREHENSION.
new text end

new text begin $....... in fiscal year 2020 is appropriated from the opioid stewardship account in the
state government special revenue fund to the Bureau of Criminal Apprehension for two
additional special agent positions within the bureau focused on drug interdiction and drug
trafficking. The special agents whose positions are authorized under this section shall,
whenever possible, coordinate with the federal Drug Enforcement Administration in efforts
to address drug trafficking in Minnesota.
new text end

Sec. 2.

new text begin COMMISSIONER OF HUMAN SERVICES.
new text end

new text begin (a) $....... in fiscal year 2020 is appropriated from the opioid stewardship account in the
state government special revenue fund to the commissioner of human services. The
commissioner, in consultation with the Opioid Stewardship Advisory Council, shall distribute
the appropriation according to this section.
new text end

new text begin (b) At least 30 percent of the available funds shall be used for county social services
agencies to provide services to children in placement. The commissioner shall distribute
the money allocated under this subdivision proportionally to counties based on the number
of open child protection case management cases in the county using data from the previous
calendar year.
new text end

new text begin (c) At least ten percent of the available funds shall be used to provide grants to county
boards to fund programs and services to prevent and treat opioid addiction.
new text end

new text begin (d) The commissioner may use up to five percent of the available funds for administration
of this section and to provide staff and administrative services for the Opioid Stewardship
Advisory Council.
new text end

new text begin (e) The remaining appropriation must be used for the following purposes:
new text end

new text begin (1) providing grants to nonprofit organizations, including grants to regional emergency
medical services programs regulated under Minnesota Statutes, section 144E.50, for the
purpose of expanding prescriber education and public awareness and the purchase of opiate
antagonists for distribution to the health care and public safety communities;
new text end

new text begin (2) providing a ... percent increase in payment rates for substance use disorder services
under Minnesota Statutes, section 254B.05, subdivision 5, beginning July 1, 2019; and
new text end

new text begin (3) providing a ... percent increase in medical assistance payment rates for mental health
services, beginning July 1, 2019.
new text end

new text begin (f) Each recipient of grants or funding for fiscal year 2020 shall report to the
commissioner and the Opioid Stewardship Advisory Council on how the funds were spent
and the outcomes achieved, in the form and manner specified by the commissioner.
new text end

Sec. 3. new text beginCOMMISSIONER OF HEALTH.
new text end

new text begin Subdivision 1. new text end

new text begin Grants to qualified entities. new text end

new text begin $....... in fiscal year 2020 is appropriated
from the opioid stewardship account in the state government special revenue fund to the
commissioner of health for grants to qualified entities for opioid addiction and substance
use disorder programs under Minnesota Statutes, section 145.9272. This is a onetime
appropriation.
new text end

new text begin Subd. 2. new text end

new text begin Opioid prevention pilot project. new text end

new text begin $....... in fiscal year 2020 is appropriated
from the opioid stewardship account in the state government special revenue fund to the
commissioner of health for opioid abuse prevention pilot projects under Laws 2017, First
Special Session chapter 6, article 10, section 144. Of this amount, $....... is for the opioid
abuse prevention pilot project through CHI St. Gabriel's Health Family Medical Center,
also known as Unity Family Health Care and $....... is for Project Echo through CHI St.
Gabriel's Health Family Medical Center for e-learning sessions centered around opioid case
management and best practices for opioid abuse prevention. This is a onetime appropriation.
new text end

new text begin Subd. 3. new text end

new text begin Non-narcotic pain management and wellness. new text end

new text begin $....... is appropriated in fiscal
year 2020 from the opioid stewardship account in the state government special revenue
fund to the commissioner of health, to provide funding for:
new text end

new text begin (1) statewide mapping and assessment of community-based non-narcotic 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, awarded
based on the results of the statewide mapping and assessment, to provide community-based
non-narcotic 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. In awarding
demonstration project grants, the commissioner shall give preference to proposals that
incorporate innovative community partnerships. This is a onetime appropriation.
new text end

Sec. 4. new text beginDEPARTMENT OF EDUCATION.
new text end

new text begin (a) $....... in fiscal year 2020 is appropriated from the opioid stewardship account in the
state government special revenue fund to the commissioner of education for a grant to a
private sector entity to collaborate with school districts throughout Minnesota to integrate
evidence-based substance misuse prevention instruction on the dangers of substance misuse,
particularly the use of opioids, into school district programs and curricula, including health
education curricula.
new text end

new text begin (b) Funds appropriated in this section are to:
new text end

new text begin (1) identify effective substance misuse prevention tools and strategies, including
innovative uses of technology and media;
new text end

new text begin (2) develop and promote a comprehensive substance misuse prevention curriculum for
students in grades 5 through 12 that educates students and families about the dangers of
substance misuse;
new text end

new text begin (3) integrate substance misuse prevention into curricula across subject areas;
new text end

new text begin (4) train school district teachers, athletic coaches, and other school staff in effective
substance misuse prevention strategies; and
new text end

new text begin (5) collaborate with school districts to evaluate the effectiveness of districts' substance
misuse prevention efforts.
new text end

new text begin (c) By February 15, 2020, the grantee must submit a report detailing expenditures and
outcomes of the grant to the chairs and ranking minority members of the legislative
committees with primary jurisdiction over kindergarten through grade 12 education policy
and finance. The report must identify the school districts that have implemented or plan to
implement the substance misuse prevention curriculum.
new text end

new text begin (d) The department may retain up to five percent of the appropriation amount to
administer the grant program and assist school districts with implementation of substance
misuse prevention instruction.
new text end

Sec. 5. new text beginHEALTH RELATED BOARDS.
new text end

new text begin Subdivision 1. new text end

new text begin Board of Dentistry; continuing education. new text end

new text begin $....... in fiscal year 2020 is
appropriated from the opioid stewardship account in the state government special revenue
fund to the Board of Dentistry for costs associated with continuing education on prescribing
opioids and controlled substances and nonpharmacologic alternatives for pain management.
This is a onetime appropriation.
new text end

new text begin Subd. 2. new text end

new text begin Board of Nursing; continuing education. new text end

new text begin $....... in fiscal year 2020 is
appropriated from the opioid stewardship account in the state government special revenue
fund to the Board of Nursing for costs associated with continuing education on prescribing
opioids and controlled substances and nonpharmacologic alternatives for pain management.
This is a onetime appropriation.
new text end

new text begin Subd. 3. new text end

new text begin Board of Optometry; continuing education. new text end

new text begin $....... in fiscal year 2020
appropriated is from the opioid stewardship account in the state government special revenue
fund to the Board of Optometry for costs associated with continuing education on prescribing
opioids and controlled substances. This is a onetime appropriation.
new text end

new text begin Subd. 4. new text end

new text begin Board of Podiatric Medicine; continuing education. new text end

new text begin $....... in fiscal year
2020 is appropriated from the opioid stewardship account in the state government special
revenue fund to the Board of Podiatric Medicine for costs associated with continuing
education on prescribing opioids and controlled substances. This is a onetime appropriation.
new text end

new text begin Subd. 5. new text end

new text begin Board of Medical Practice; continuing education. new text end

new text begin $....... in fiscal year 2020
is appropriated from the opioid stewardship account in the state government special revenue
fund to the Board of Medical Practice for costs associated with continuing education on
prescribing opioids and controlled substances and nonpharmacologic alternatives for pain
management. This is a onetime appropriation.
new text end

new text begin Subd. 6. new text end

new text begin Board of Pharmacy. new text end

new text begin $....... in fiscal year 2020 is appropriated from the opioid
stewardship account in the state government special revenue fund to the Board of Pharmacy
for collection of the registration fee under Minnesota Statutes, section 151.77. This is a
onetime appropriation.
new text end

Sec. 6. new text beginDEPARTMENT OF COMMERCE.
new text end

new text begin $....... in fiscal year 2020 is appropriated from the opioid stewardship account in the
state government special revenue fund to the commissioner of commerce to implement
Minnesota Statutes, chapter 62W.
new text end