SF 1960

1st Engrossment - 91st Legislature (2019 - 2020) Posted on 06/01/2020 10:26am

A bill for an act
relating to health; authorizing pharmacists to prescribe self-administered hormonal
contraceptives, tobacco and nicotine cessation medications and products, and
opiate antagonists for the treatment of acute opiate overdose; amending Minnesota
Statutes 2018, sections 151.01, by adding a subdivision; 151.37, by adding
subdivisions; 256B.0625, subdivision 13h; Minnesota Statutes 2019 Supplement,
sections 151.01, subdivisions 23, 27; 256B.0625, subdivision 13; proposing coding
for new law in Minnesota Statutes, chapter 62Q.

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

Section 1.

new text begin [62Q.529] COVERAGE FOR DRUGS PRESCRIBED AND DISPENSED
BY PHARMACIES.
new text end

new text begin (a) A health plan that provides prescription coverage must provide coverage for
self-administered hormonal contraceptives, nicotine replacement medications, and opiate
antagonists for the treatment of an acute opiate overdose prescribed and dispensed by a
licensed pharmacist in accordance with section 151.37, subdivision 14, 15, or 16, under the
same terms of coverage that would apply had the prescription drug been prescribed by a
licensed physician, physician assistant, or advanced practice nurse practitioner.
new text end

new text begin (b) A health plan is not required to cover the drug if dispensed by an out-of-network
pharmacy, unless the health plan covers prescription drugs dispensed by out-of-network
pharmacies.
new text end

Sec. 2.

Minnesota Statutes 2019 Supplement, section 151.01, subdivision 23, is amended
to read:

Subd. 23.

Practitioner.

"Practitioner" means a licensed doctor of medicine, licensed
doctor of osteopathic medicine duly licensed to practice medicine, licensed doctor of
dentistry, licensed doctor of optometry, licensed podiatrist, licensed veterinarian, or licensed
advanced practice registered nurse. For purposes of sections 151.15, subdivision 4; 151.211,
subdivision 3; 151.252, subdivision 3; 151.37, subdivision 2, paragraphs (b), (e), and (f);
and 151.461, "practitioner" also means a physician assistant authorized to prescribe, dispense,
and administer under chapter 147A. For purposes of sections 151.15, subdivision 4; 151.211,
subdivision 3; 151.252, subdivision 3; 151.37, subdivision 2, paragraph (b); and 151.461,
"practitioner" also means a dental therapist authorized to dispense and administer under
chapter 150A. new text begin For purposes of sections 151.252, subdivision 3, and 151.461, "practitioner"
also means a pharmacist authorized to prescribe self-administered hormonal contraceptives,
nicotine replacement medications, or opiate antagonists under section 151.37, subdivision
14, 15, or 16.
new text end

Sec. 3.

Minnesota Statutes 2019 Supplement, 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; intramuscular and subcutaneous administration used for
the treatment of alcohol or opioid dependence; drug regimen reviews; and drug or
drug-related research;

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

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

(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;

(6) 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 new text begin registered new text end 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;

(7) 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
new text begin registered new text end 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;

(8) participation in the storage of drugs and the maintenance of records;

(9) patient counseling on therapeutic values, content, hazards, and uses of drugs and
devices;

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

(11) 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 new text begin ;
and
new text end

new text begin (12) prescribing self-administered hormonal contraceptives; nicotine replacement
medications; and opiate antagonists for the treatment of an acute opiate overdose pursuant
to section 151.37, subdivision 14, 15, or 16 new text end .

Sec. 4.

Minnesota Statutes 2018, section 151.01, is amended by adding a subdivision to
read:

new text begin Subd. 42. new text end

new text begin Self-administered hormonal contraceptive. new text end

new text begin "Self-administered hormonal
contraceptive" means a drug composed of a combination of hormones that is approved by
the United States Food and Drug Administration to prevent pregnancy and is administered
by the user.
new text end

Sec. 5.

Minnesota Statutes 2018, section 151.37, is amended by adding a subdivision to
read:

new text begin Subd. 14. new text end

new text begin Self-administered hormonal contraceptives. new text end

new text begin (a) A pharmacist is authorized
to prescribe self-administered hormonal contraceptives if the intended use is contraception
in accordance with this subdivision. By January 1, 2021, the board shall develop a
standardized protocol for the pharmacist to follow in prescribing self-administrated hormonal
contraceptives. In developing the protocol, the board shall consult with the Minnesota Board
of Medical Practice; the Minnesota Board of Nursing; the commissioner of health; the
Minnesota section of the American Congress of Obstetricians and Gynecologists; professional
pharmacy associations; and professional associations of physicians, physician assistants,
and advanced practice registered nurses. The protocol must, at a minimum, include:
new text end

new text begin (1) requiring the patient to complete a self-screening tool to identify patient risk factors
for the use of self-administered hormonal contraceptives, based on the current United States
Medical Eligibility Criteria for Contraceptive Use developed by the federal Centers for
Disease Control and Prevention;
new text end

new text begin (2) requiring the pharmacist to review the screening tool with the patient;
new text end

new text begin (3) other assessments the pharmacist should make before prescribing self-administered
hormonal contraceptives;
new text end

new text begin (4) situations when the prescribing of self-administered hormonal contraceptives by a
pharmacist is contraindicated;
new text end

new text begin (5) situations when the pharmacist must refer a patient to the patient's primary care
provider or, if the patient does not have a primary care provider, to a nearby clinic or hospital;
and
new text end

new text begin (6) any additional information concerning the requirements and prohibitions in this
subdivision that the board considers necessary.
new text end

new text begin (b) Before a pharmacist is authorized to prescribe a self-administered hormonal
contraceptive to a patient under this subdivision, the pharmacist shall successfully complete
a training program on prescribing self-administered hormonal contraceptives that is offered
by a college of pharmacy or by a continuing education provider that is accredited by the
Accreditation Council for Pharmacy Education, or a program approved by the board. To
maintain authorization to prescribe, the pharmacist shall complete continuing education
requirements as specified by the board.
new text end

new text begin (c) Before prescribing a self-administered hormonal contraceptive, the pharmacist shall
follow the standardized protocol developed under paragraph (a), and if appropriate, may
prescribe a self-administered hormonal contraceptive to a patient, if the patient is:
new text end

new text begin (1) 18 years of age or older; or
new text end

new text begin (2) under the age of 18 if the patient has previously been prescribed a self-administered
hormonal contraceptive by a licensed physician, physician assistant, or advanced practice
registered nurse.
new text end

new text begin (d) The pharmacist shall provide counseling to the patient on the use of self-administered
hormonal contraceptives and provide the patient with a fact sheet that includes but is not
limited to the contraindications for use of the drug, the appropriate method for using the
drug, the need for medical follow-up, and any additional information listed in Minnesota
Rules, part 6800.0910, subpart 2, that is required to be given to a patient during the counseling
process. The pharmacist shall also provide the patient with a written record of the
self-administered hormonal contraceptive prescribed by the pharmacist.
new text end

new text begin (e) If a pharmacist prescribes and dispenses a self-administered hormonal contraceptive
under this subdivision, the pharmacist shall not prescribe a refill to the patient unless the
patient has evidence of a clinical visit with a physician, physician assistant, or advanced
practice registered nurse within the preceding three years.
new text end

new text begin (f) A pharmacist who is authorized to prescribe a self-administered hormonal
contraceptive is prohibited from delegating the prescribing to any other person. A pharmacist
intern registered pursuant to section 151.101 may prepare a prescription for a
self-administered hormonal contraceptive, but before the prescription is processed or
dispensed, a pharmacist authorized to prescribe under this subdivision must review, approve,
and sign the prescription.
new text end

new text begin (g) Nothing in this subdivision prohibits a pharmacist from participating in the initiation,
management, modification, and discontinuation of drug therapy according to a protocol or
collaborative agreement as authorized in this section and in section 151.01, subdivision 27.
new text end

Sec. 6.

Minnesota Statutes 2018, section 151.37, is amended by adding a subdivision to
read:

new text begin Subd. 15. new text end

new text begin Nicotine replacement medications. new text end

new text begin (a) A pharmacist is authorized to prescribe
nicotine replacement medications approved by the United States Food and Drug
Administration in accordance with this subdivision. By January 1, 2021, the board shall
develop a standardized protocol for the pharmacist to follow in prescribing nicotine
replacement medications. In developing the protocol, the board shall consult with the
Minnesota Board of Medical Practice; the Minnesota Board of Nursing; the commissioner
of health; professional pharmacy associations; and professional associations of physicians,
physician assistants, and advanced practice registered nurses.
new text end

new text begin (b) Before a pharmacist is authorized to prescribe nicotine replacement medications
under this subdivision, the pharmacist shall successfully complete a training program
specifically developed for prescribing nicotine replacement medications that is offered by
a college of pharmacy or by a continuing education provider that is accredited by the
Accreditation Council for Pharmacy Education, or a program approved by the board. To
maintain authorization to prescribe, the pharmacist shall complete continuing education
requirements as specified by the board.
new text end

new text begin (c) Before prescribing a nicotine replacement medication, the pharmacist shall follow
the appropriate standardized protocol developed under paragraph (a), and if appropriate,
may dispense to a patient a nicotine replacement medication.
new text end

new text begin (d) The pharmacist shall provide counseling to the patient on the use of the nicotine
replacement medication and provide the patient with a fact sheet that includes but is not
limited to the indications and contraindications for use of a nicotine replacement medication,
the appropriate method for using the medication or product, the need for medical follow-up,
and any additional information listed in Minnesota Rules, part 6800.0910, subpart 2, that
is required to be given to a patient during the counseling process. The pharmacist shall also
provide the patient with a written record of the medication prescribed by the pharmacist.
new text end

new text begin (e) A pharmacist who is authorized to prescribe a nicotine replacement medication under
this subdivision is prohibited from delegating the prescribing of the medication to any other
person. A pharmacist intern registered pursuant to section 151.101 may prepare a prescription
for the medication, but before the prescription is processed or dispensed, a pharmacist
authorized to prescribe under this subdivision must review, approve, and sign the prescription.
new text end

new text begin (f) Nothing in this subdivision prohibits a pharmacist from participating in the initiation,
management, modification, and discontinuation of drug therapy according to a protocol or
collaborative agreement as authorized in this section and in section 151.01, subdivision 27.
new text end

Sec. 7.

Minnesota Statutes 2018, section 151.37, is amended by adding a subdivision to
read:

new text begin Subd. 16. new text end

new text begin Opiate antagonists for the treatment of an acute opiate overdose. new text end

new text begin (a) A
pharmacist is authorized to prescribe opiate antagonists for the treatment of an acute opiate
overdose. By January 1, 2021, the board shall develop a standardized protocol for the
pharmacist to follow in prescribing an opiate antagonist. In developing the protocol, the
board shall consult with the Minnesota Board of Medical Practice; the Minnesota Board of
Nursing; the commissioner of health; professional pharmacy associations; and professional
associations of physicians, physician assistants, and advanced practice registered nurses.
new text end

new text begin (b) Before a pharmacist is authorized to prescribe an opiate antagonist under this
subdivision, the pharmacist shall successfully complete a training program specifically
developed for prescribing opiate antagonists for the treatment of an acute opiate overdose
that is offered by a college of pharmacy or by a continuing education provider that is
accredited by the Accreditation Council for Pharmacy Education, or a program approved
by the board. To maintain authorization to prescribe, the pharmacist shall complete continuing
education requirements as specified by the board.
new text end

new text begin (c) Before prescribing an opiate antagonist under this subdivision, the pharmacist shall
follow the appropriate standardized protocol developed under paragraph (a), and if
appropriate, may dispense to a patient an opiate antagonist.
new text end

new text begin (d) The pharmacist shall provide counseling to the patient on the use of the opiate
antagonist and provide the patient with a fact sheet that includes but is not limited to the
indications and contraindications for use of the opiate antagonist, the appropriate method
for using the opiate antagonist, the need for medical follow-up, and any additional
information listed in Minnesota Rules, part 6800.0910, subpart 2, that is required to be given
to a patient during the counseling process. The pharmacist shall also provide the patient
with a written record of the opiate antagonist prescribed by the pharmacist.
new text end

new text begin (e) A pharmacist who prescribes an opiate antagonist under this subdivision is prohibited
from delegating the prescribing of the medication to any other person. A pharmacist intern
registered pursuant to section 151.101 may prepare the prescription for the opiate antagonist,
but before the prescription is processed or dispensed, a pharmacist authorized to prescribe
under this subdivision must review, approve, and sign the prescription.
new text end

new text begin (f) Nothing in this subdivision prohibits a pharmacist from participating in the initiation,
management, modification, and discontinuation of drug therapy according to a protocol as
authorized in this section and in section 151.01, subdivision 27.
new text end

Sec. 8.

Minnesota Statutes 2019 Supplement, section 256B.0625, subdivision 13, is
amended to read:

Subd. 13.

Drugs.

(a) Medical assistance covers drugs, except for fertility drugs when
specifically used to enhance fertility, if prescribed by a licensed practitioner and dispensed
by a licensed pharmacist, by a physician enrolled in the medical assistance program as a
dispensing physician, or by a physician, physician assistant, or a nurse practitioner employed
by or under contract with a community health board as defined in section 145A.02,
subdivision 5, for the purposes of communicable disease control.

(b) The dispensed quantity of a prescription drug must not exceed a 34-day supply,
unless authorized by the commissioner.

(c) For the purpose of this subdivision and subdivision 13d, an "active pharmaceutical
ingredient" is defined as a substance that is represented for use in a drug and when used in
the manufacturing, processing, or packaging of a drug becomes an active ingredient of the
drug product. An "excipient" is defined as an inert substance used as a diluent or vehicle
for a drug. The commissioner shall establish a list of active pharmaceutical ingredients and
excipients which are included in the medical assistance formulary. Medical assistance covers
selected active pharmaceutical ingredients and excipients used in compounded prescriptions
when the compounded combination is specifically approved by the commissioner or when
a commercially available product:

(1) is not a therapeutic option for the patient;

(2) does not exist in the same combination of active ingredients in the same strengths
as the compounded prescription; and

(3) cannot be used in place of the active pharmaceutical ingredient in the compounded
prescription.

(d) Medical assistance covers the following over-the-counter drugs when prescribed by
a licensed practitioner or by a licensed pharmacist who meets standards established by the
commissioner, in consultation with the board of pharmacy: antacids, acetaminophen, family
planning products, aspirin, insulin, products for the treatment of lice, vitamins for adults
with documented vitamin deficiencies, vitamins for children under the age of seven and
pregnant or nursing women, and any other over-the-counter drug identified by the
commissioner, in consultation with the Formulary Committee, as necessary, appropriate,
and cost-effective for the treatment of certain specified chronic diseases, conditions, or
disorders, and this determination shall not be subject to the requirements of chapter 14. A
pharmacist may prescribe over-the-counter medications as provided under this paragraph
for purposes of receiving reimbursement under Medicaid. When prescribing over-the-counter
drugs under this paragraph, licensed pharmacists must consult with the recipient to determine
necessity, provide drug counseling, review drug therapy for potential adverse interactions,
and make referrals as needed to other health care professionals.

(e) Effective January 1, 2006, medical assistance shall not cover drugs that are coverable
under Medicare Part D as defined in the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, Public Law 108-173, section 1860D-2(e), for individuals eligible
for drug coverage as defined in the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, Public Law 108-173, section 1860D-1(a)(3)(A). For these
individuals, medical assistance may cover drugs from the drug classes listed in United States
Code, title 42, section 1396r-8(d)(2), subject to this subdivision and subdivisions 13a to
13g, except that drugs listed in United States Code, title 42, section 1396r-8(d)(2)(E), shall
not be covered.

(f) Medical assistance covers drugs acquired through the federal 340B Drug Pricing
Program and dispensed by 340B covered entities and ambulatory pharmacies under common
ownership of the 340B covered entity. Medical assistance does not cover drugs acquired
through the federal 340B Drug Pricing Program and dispensed by 340B contract pharmacies.

new text begin (g) Notwithstanding paragraph (a), medical assistance covers self-administered hormonal
contraceptives prescribed and dispensed by a licensed pharmacist in accordance with section
151.37, subdivision 14; nicotine replacement medications prescribed and dispensed by a
licensed pharmacist in accordance with section 151.37, subdivision 15; and opiate antagonists
used for the treatment of an acute opiate overdose prescribed and dispensed by a licensed
pharmacist in accordance with section 151.37, subdivision 16.
new text end

Sec. 9.

Minnesota Statutes 2018, section 256B.0625, subdivision 13h, is amended to read:

Subd. 13h.

Medication therapy management services.

(a) Medical assistance covers
medication therapy management services for a recipient taking prescriptions to treat or
prevent one or more chronic medical conditions. For purposes of this subdivision,
"medication therapy management" means the provision of the following pharmaceutical
care services by a licensed pharmacist to optimize the therapeutic outcomes of the patient's
medications:

(1) performing or obtaining necessary assessments of the patient's health status;

(2) formulating a medication treatment plan new text begin , which may include prescribing medications
or products in accordance with section 151.37, subdivision 14, 15, or 16 new text end ;

(3) monitoring and evaluating the patient's response to therapy, including safety and
effectiveness;

(4) performing a comprehensive medication review to identify, resolve, and prevent
medication-related problems, including adverse drug events;

(5) documenting the care delivered and communicating essential information to the
patient's other primary care providers;

(6) providing verbal education and training designed to enhance patient understanding
and appropriate use of the patient's medications;

(7) providing information, support services, and resources designed to enhance patient
adherence with the patient's therapeutic regimens; and

(8) coordinating and integrating medication therapy management services within the
broader health care management services being provided to the patient.

Nothing in this subdivision shall be construed to expand or modify the scope of practice of
the pharmacist as defined in section 151.01, subdivision 27.

(b) To be eligible for reimbursement for services under this subdivision, a pharmacist
must meet the following requirements:

(1) have a valid license issued by the Board of Pharmacy of the state in which the
medication therapy management service is being performed;

(2) have graduated from an accredited college of pharmacy on or after May 1996, or
completed a structured and comprehensive education program approved by the Board of
Pharmacy and the American Council of Pharmaceutical Education for the provision and
documentation of pharmaceutical care management services that has both clinical and
didactic elements;

(3) be practicing in an ambulatory care setting as part of a multidisciplinary team or
have developed a structured patient care process that is offered in a private or semiprivate
patient care area that is separate from the commercial business that also occurs in the setting,
or in home settings, including long-term care settings, group homes, and facilities providing
assisted living services, but excluding skilled nursing facilities; and

(4) make use of an electronic patient record system that meets state standards.

(c) For purposes of reimbursement for medication therapy management services, the
commissioner may enroll individual pharmacists as medical assistance providers. The
commissioner may also establish contact requirements between the pharmacist and recipient,
including limiting the number of reimbursable consultations per recipient.

(d) If there are no pharmacists who meet the requirements of paragraph (b) practicing
within a reasonable geographic distance of the patient, a pharmacist who meets the
requirements may provide the services via two-way interactive video. Reimbursement shall
be at the same rates and under the same conditions that would otherwise apply to the services
provided. To qualify for reimbursement under this paragraph, the pharmacist providing the
services must meet the requirements of paragraph (b), and must be located within an
ambulatory care setting that meets the requirements of paragraph (b), clause (3). The patient
must also be located within an ambulatory care setting that meets the requirements of
paragraph (b), clause (3). Services provided under this paragraph may not be transmitted
into the patient's residence.

(e) Medication therapy management services may be delivered into a patient's residence
via secure interactive video if the medication therapy management services are performed
electronically during a covered home care visit by an enrolled provider. Reimbursement
shall be at the same rates and under the same conditions that would otherwise apply to the
services provided. To qualify for reimbursement under this paragraph, the pharmacist
providing the services must meet the requirements of paragraph (b) and must be located
within an ambulatory care setting that meets the requirements of paragraph (b), clause (3).