HF 3854

as introduced - 92nd Legislature (2021 - 2022) Posted on 02/28/2022 02:12pm

A bill for an act
relating to health care; authorizing pharmacists to prescribe, dispense, and
administer drugs to prevent the acquisition of human immunodeficiency virus;
authorizing pharmacists to order, conduct, and interpret laboratory tests necessary
for therapy that uses drugs to prevent the acquisition of human immunodeficiency
virus; amending Minnesota Statutes 2020, sections 151.01, subdivisions 23, 27;
151.37, by adding a subdivision; 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.1842] PROHIBITION ON USE OF STEP THERAPY FOR
ANTIRETROVIRAL DRUGS.
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) "Health plan" has the meaning given in section 62Q.01, subdivision 3, and includes
health coverage provided by a managed care plan or a county-based purchasing plan
participating in a public program under chapter 256B or 256L or an integrated health
partnership under section 256B.0755.
new text end

new text begin (c) "Step therapy protocol" has the meaning given in section 62Q.184.
new text end

new text begin Subd. 2. new text end

new text begin Prohibition on use of step therapy protocols. new text end

new text begin A health plan that covers
antiretroviral drugs that are medically necessary for the prevention of HIV/AIDS, including
preexposure prophylaxis and postexposure prophylaxis, must not limit or exclude coverage
for the antiretroviral drugs by requiring prior authorization or by requiring an enrollee to
follow a step therapy protocol.
new text end

Sec. 2.

new text begin [62Q.524] COVERAGE FOR DRUGS TO PREVENT THE ACQUISITION
OF HUMAN IMMUNODEFICIENCY VIRUS.
new text end

new text begin (a) A health plan that provides prescription drug coverage must provide coverage in
accordance with this section for:
new text end

new text begin (1) any antiretroviral drug approved by the United States Food and Drug Administration
(FDA) for preventing the acquisition of human immunodeficiency virus (HIV) that is
prescribed, dispensed, or administered by a pharmacist who meets the requirements described
in section 151.37, subdivision 17; and
new text end

new text begin (2) any laboratory testing necessary for therapy that uses the drugs described in clause
(1) that is ordered, performed, and interpreted by a pharmacist who meets the requirements
described in section 151.37, subdivision 17.
new text end

new text begin (b) A health plan must provide the same terms of prescription drug coverage for drugs
to prevent the acquisition of HIV that are prescribed or administered by a pharmacist if the
pharmacist meets the requirements described in section 151.37, subdivision 17, as would
apply had the drug been prescribed or administered by a physician, physician assistant, or
advanced practice registered nurse. The health plan may require pharmacists or pharmacies
to meet reasonable medical management requirements when providing the services described
in paragraph (a) if other providers are required to meet the same requirements.
new text end

new text begin (c) A health plan must reimburse an in-network pharmacist or pharmacy for the drugs
and testing described in paragraph (a) at a rate equal to the rate of reimbursement provided
to a physician, physician assistant, or advanced practice registered nurse if providing similar
services.
new text end

new text begin (d) A health plan is not required to cover the drugs and testing described in paragraph
(a) if provided by a pharmacist or pharmacy that is out-of-network unless the health plan
covers similar services provided by out-of-network providers. A health plan must ensure
that the health plan's provider network includes in-network pharmacies that provide the
services described in paragraph (a).
new text end

Sec. 3.

Minnesota Statutes 2020, 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, licensed
advanced practice registered nurse, or licensed physician assistant. 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. 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 begin , or authorized to prescribe drugs
to prevent the acquisition of human immunodeficiency virus (HIV) under section 151.37,
subdivision 17 new text end .

Sec. 4.

Minnesota Statutes 2020, 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 and vaccines approved by the
United States Food and Drug Administration related to COVID-19 or SARS-CoV-2 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 registered 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
registered 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;

(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 (7); 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;
deleted text begin and
deleted text end

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

new text begin (13) prescribing, dispensing, and administering drugs for preventing the acquisition of
human immunodeficiency virus (HIV) if the pharmacist meets the requirements under
section 151.37, subdivision 17; and
new text end

new text begin (14) ordering, conducting, and interpreting laboratory tests necessary for therapies that
use drugs for preventing the acquisition of human immunodeficiency virus (HIV), if the
pharmacist meets the requirements under section 151.37, subdivision 17.
new text end

Sec. 5.

Minnesota Statutes 2020, section 151.37, is amended by adding a subdivision to
read:

new text begin Subd. 17. new text end

new text begin Drugs for preventing the acquisition of HIV. new text end

new text begin (a) A pharmacist is authorized
to prescribe and administer drugs to prevent the acquisition of human immunodeficiency
virus (HIV) in accordance with this subdivision.
new text end

new text begin (b) By January 1, 2023, the board of pharmacy shall develop a standardized protocol
for a pharmacist to follow in prescribing the drugs described in paragraph (a). In developing
the protocol, the board may consult with community health advocacy groups, the board of
medical practice, the board of nursing, the commissioner of health, professional pharmacy
associations, and professional associations for physicians, physician assistants, and advanced
practice registered nurses.
new text end

new text begin (c) Before a pharmacist is authorized to prescribe a drug described in paragraph (a), the
pharmacist must successfully complete a training program specifically developed for
prescribing drugs for preventing the acquisition of HIV that is offered by a college of
pharmacy, 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 (d) Before prescribing a drug described in paragraph (a), the pharmacist shall follow the
appropriate standardized protocol developed under paragraph (b) and, if appropriate, may
dispense to a patient a drug described in paragraph (a).
new text end

new text begin (e) Before dispensing a drug described under paragraph (a) that is prescribed by the
pharmacist, the pharmacist must provide counseling to the patient on the use of the drugs
and must provide the patient with a fact sheet that includes the indications and
contraindications for the use of these drugs, the appropriate method for using these drugs,
the need for medical follow up, and any other additional information listed in Minnesota
Rules, part 6800.0910, subpart 2, that is required to be provided to a patient during the
counseling process.
new text end

new text begin (f) A pharmacist is prohibited from delegating the prescribing authority provided under
this subdivision to any other person. A pharmacist intern registered under section 151.101
may prepare the prescription, 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 as
authorized in this section and in section 151.01, subdivision 27.
new text end