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Minnesota Legislature

Office of the Revisor of Statutes

SF 1960

as introduced - 91st Legislature (2019 - 2020) Posted on 04/05/2019 04:25pm

KEY: stricken = removed, old language.
underscored = added, new language.

Current Version - as introduced

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A bill for an act
relating to health; authorizing pharmacists to prescribe self-administered hormonal
contraceptives, tobacco and nicotine cessation medications and products, opiate
antagonists, and travel medications; amending Minnesota Statutes 2018, sections
151.01, subdivisions 23, 27, by adding a subdivision; 256B.0625, subdivision 13h;
proposing coding for new law in Minnesota Statutes, chapter 151.

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

Section 1.

Minnesota Statutes 2018, 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; new text begin151.216;
new text end 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; 151.252,
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
who is prescribing self-administered hormonal contraceptives, tobacco and nicotine cessation
medications and products, and opiate antagonists.
new text end

Sec. 2.

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; drug regimen reviews; and drug or drug-related research;

(5) 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;

(6) 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;

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

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

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

(10) 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
13deleted text begin.deleted text endnew text begin; and
new text end

new text begin (11) prescribing self-administered hormonal contraceptives, tobacco and nicotine
cessation medications and products, and opiate antagonists pursuant to section 152.216.
new text end

Sec. 3.

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. 4.

new text begin [151.216] PHARMACIST PRESCRIBING.
new text end

new text begin Subdivision 1. 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, when the intended use
is contraception, to a person who is:
new text end

new text begin (1) at least 18 years of age, regardless of whether the person has evidence of a previous
prescription from a practitioner other than a pharmacist for a self-administered hormonal
contraceptive; or
new text end

new text begin (2) under 18 years of age, only if the person has evidence of a previous prescription
from a practitioner other than a pharmacist for a self-administered hormonal contraceptive.
new text end

new text begin (b) A pharmacist who prescribes self-administered hormonal contraceptives must:
new text end

new text begin (1) successfully complete a training program specifically developed for the prescribing
of self-administered hormonal contraceptives that is provided 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;
new text end

new text begin (2) follow the standardized protocol developed under this subdivision;
new text end

new text begin (3) 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;
and
new text end

new text begin (4) provide the patient with a written record of the self-administered hormonal
contraceptive prescribed by the pharmacist.
new text end

new text begin (c) A pharmacist who prescribes self-administered hormonal contraceptives is prohibited
from:
new text end

new text begin (1) prescribing and dispensing self-administered hormonal contraceptives to a patient
who does not have evidence of a clinical visit with a practitioner other than a pharmacist
within the three years immediately following the pharmacist's initial prescription of a
self-administered hormonal contraceptive to the patient; and
new text end

new text begin (2) delegating the prescribing of a self-administered hormonal contraceptive to any other
person. A pharmacist may allow a pharmacist intern registered pursuant to section 151.101
to prepare a prescription for a self-administered hormonal contraceptive, provided that the
prescription shall not be processed or dispensed until it is reviewed, approved, and signed
by the pharmacist.
new text end

new text begin (d) The board shall develop a standardized protocol that pharmacists must follow to
prescribe self-administered hormonal contraceptives. In developing the protocol, the board
shall:
new text end

new text begin (1) 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;
and
new text end

new text begin (2) ensure that the protocol includes, at a minimum:
new text end

new text begin (i) a provision requiring the patient to complete a self-screening tool that will 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, and requiring the pharmacist to review
the completed self-screening tool;
new text end

new text begin (ii) instructions concerning how pharmacists should review the completed self-screening
tool;
new text end

new text begin (iii) instructions concerning any other assessments a pharmacist should make before
prescribing self-administered hormonal contraceptives;
new text end

new text begin (iv) instructions about situations in which the prescribing of self-administered hormonal
contraceptives by a pharmacist is contraindicated;
new text end

new text begin (v) instructions for situations in which a pharmacist should refer the 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 (vi) any additional information concerning the requirements and prohibitions in this
subdivision that the board considers necessary.
new text end

new text begin Subd. 2. new text end

new text begin Tobacco and nicotine cessation medications and products and opiate
antagonists.
new text end

new text begin (a) A pharmacist is authorized to prescribe nicotine replacement products
approved by the United States Food and Drug Administration and opiate antagonists.
new text end

new text begin (b) A pharmacist who prescribes products or medications under this subdivision must:
new text end

new text begin (1) successfully complete a training program specifically developed for the prescribing
of the product or medication that is provided 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;
new text end

new text begin (2) follow the appropriate standardized protocol developed under this subdivision;
new text end

new text begin (3) provide the patient with a fact sheet that includes but is not limited to the indications
and contraindications for use of the product or medication, the appropriate method for using
the product or medication, 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; and
new text end

new text begin (4) provide the patient with a written record of the product or medication prescribed by
the pharmacist.
new text end

new text begin (c) A pharmacist who prescribes products or medications under this subdivision is
prohibited from delegating the prescribing of the product or medication to any other person,
but may allow a pharmacist intern registered pursuant to section 151.101 to prepare a
prescription for such product or medication, provided that such prescription shall not be
processed or dispensed until it is reviewed, approved, and signed by the pharmacist.
new text end

new text begin (d) The board shall develop standardized protocols that pharmacists must follow in order
to prescribe products and medications under this subdivision. In developing the protocols,
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 (e) Nothing in this subdivision prohibits a pharmacist from participating in the initiation,
management, modification, and discontinuation of therapy through a protocol as allowed
in this section or section 151.37, subdivisions 2 and 13.
new text end

new text begin Subd. 3. new text end

new text begin Insurance coverage. new text end

new text begin All state and federal laws governing insurance coverage
of self-administered contraceptive drugs, tobacco and nicotine cessation medications and
products, and opiate antagonists shall apply when those products are prescribed by a
pharmacist under this section.
new text end

Sec. 5.

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;

(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; deleted text beginand
deleted text end

(8) coordinating and integrating medication therapy management services within the
broader health care management services being provided to the patientdeleted text begin.deleted text endnew text begin; and
new text end

new text begin (9) prescribing products or medications as permitted under section 151.216, in accordance
with standardized protocols developed by the Board of Pharmacy.
new text end

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).