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SF 3884

as introduced - 91st Legislature (2019 - 2020) Posted on 03/03/2020 09:40am

KEY: stricken = removed, old language.
underscored = added, new language.
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A bill for an act
relating to health care; authorizing pharmacists to dispense preexposure prophylaxis
and postexposure prophylaxis without a prescription; amending Minnesota Statutes
2018, section 151.37, by adding subdivisions; Minnesota Statutes 2019 Supplement,
sections 151.01, subdivision 27; 151.06, subdivision 6; 214.122; 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.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) A health plan that covers
antiretroviral drugs that are medically necessary for the prevention of AIDS/HIV, 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, except as provided in paragraph (b).
new text end

new text begin (b) If the United States Food and Drug Administration has approved one or more
therapeutic equivalents of a drug, device, or product for the prevention of AIDS/HIV, a
health plan is not required to cover all of the therapeutically equivalent versions without
prior authorization or a step therapy protocol requirement so long as at least one
therapeutically equivalent version is covered without requiring prior authorization or the
use of a step therapy protocol.
new text end

Sec. 2.

new text begin [62Q.529] COVERAGE FOR HIV PREEXPOSURE PROPHYLAXIS AND
HIV POSTEXPOSURE PROPHYLAXIS.
new text end

new text begin (a) A health plan that provides prescription coverage must provide coverage for
preexposure and postexposure prophylaxis dispensed by a pharmacist under section 151.37,
subdivision 14 or 15, under the same terms of coverage that would apply had the prescription
drug been dispensed according to a valid prescription drug order.
new text end

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

new text begin (c) A health plan is not required to cover preexposure prophylaxis dispensed by a
pharmacist as authorized by section 151.37, subdivision 14, if the enrollee has already
received a 60-day supply within a two-year period unless the preexposure prophylaxis drug
is dispensed by the pharmacist pursuant to a valid prescription drug order.
new text end

new text begin (d) A health plan company must not prohibit or permit a pharmacy benefit manager to
prohibit a pharmacy provider from dispensing preexposure prophylaxis or postexposure
prophylaxis as a term or condition of a pharmacy in-network contract.
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 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
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 beginand
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 13new text begin;
and
new text end

new text begin (12) the administration of HIV preexposure prophylaxis and HIV postexposure
prophylaxis as authorized under section 151.37, subdivision 14 or 15
new text end.

Sec. 4.

Minnesota Statutes 2019 Supplement, section 151.06, subdivision 6, is amended
to read:


Subd. 6.

Information provision; sources of lower cost prescription drugs.

(a) The
board shall publish a page on its website that provides regularly updated information
concerning:

(1) patient assistance programs offered by drug manufacturers, including information
on how to access the programs;

(2) the prescription drug assistance program established by the Minnesota Board of
Aging under section 256.975, subdivision 9;

(3) the websites through which individuals can access information concerning eligibility
for and enrollment in Medicare, medical assistance, MinnesotaCare, and other
government-funded programs that help pay for the cost of health care;

(4) availability of providers that are authorized to participate under section 340b of the
federal Public Health Services Act, United States Code, title 42, section 256b;

(5) having a discussion with the pharmacist or the consumer's health care provider about
alternatives to a prescribed drug, including a lower cost or generic drug if the drug prescribed
is too costly for the consumer; deleted text beginand
deleted text end

(6) new text begininformation on the availability of preexposure and postexposure prophylaxis, including
how to obtain these drugs with or without a prescription, in accordance with section 151.37,
subdivision 14 or 15; and
new text end

new text begin (7) new text endany other resource that the board deems useful to individuals who are attempting to
purchase prescription drugs at lower costs.

(b) The board must prepare educational materials, including brochures and posters, based
on the information it provides on its website under paragraph (a). The materials must be in
a form that can be downloaded from the board's website and used for patient education by
pharmacists and by health care practitioners who are licensed to prescribe. The board is not
required to provide printed copies of these materials.

(c) The board shall require pharmacists and pharmacies to make available to patients
information on sources of lower cost prescription drugs, including information on the
availability of the website established under paragraph (a).

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 HIV preexposure prophylaxis. new text end

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

new text begin (1) "preexposure prophylaxis" means a fixed dose combination of tenofovir disoproxil
fumarate (TDF) (300 milligrams) with emtricitabine (FTC) (200 milligrams), or another
drug or drug combination determined by the board to meet the same clinical eligibility
recommendations provided in United States Centers for Disease Control and Prevention
(CDC) guidelines; and
new text end

new text begin (2) "CDC guidelines" means the "2017 Preexposure Prophylaxis for the Prevention of
HIV Infection in the United States-2017 Update: A Clinical Practice Guidelines" or any
subsequent guidelines published by the CDC.
new text end

new text begin (b) A pharmacist may dispense HIV preexposure prophylaxis without a prescription
drug order in accordance with this subdivision.
new text end

new text begin (c) Before dispensing a preexposure prophylaxis to a patient, a pharmacist must complete
a training program approved by the board on the use of preexposure prophylaxis and
postexposure prophylaxis. The training program must include information on financial
assistance programs for preexposure prophylaxis and postexposure prophylaxis, including
patient assistance programs offered by drug manufacturers and the AIDS drug assistance
program administered by the Department of Human Services. The board must approve a
training program in consultation with the Board of Medical Practice, the commissioners of
human services and health, and other relevant stakeholders by January 1, 2021.
new text end

new text begin (d) If a pharmacist completes the training program required under paragraph (c), the
pharmacist may dispense a preexposure prophylaxis to a patient if the patient:
new text end

new text begin (1) is HIV negative, as documented by a negative HIV test result obtained within the
previous seven days from an HIV antigen/antibody test, an antibody only test, or a rapid,
point-of-care finger stick blood test approved by the United States Food and Drug
Administration. If the test results are not provided directly to the pharmacist, the pharmacist
must verify the test results to the pharmacist's satisfaction. If the patient does not provide
evidence of a negative HIV test in accordance with this clause, the pharmacist must either
administer an HIV test to the patient or provide the patient with information on where to
locally obtain an HIV test. If the pharmacist does not receive documentation of a negative
HIV test to the satisfaction of the pharmacist, the pharmacist may dispense up to a ten-day
supply of preexposure prophylaxis to the patient if the patient satisfies clauses (2) and (3).
If the patient tests positive for HIV, the pharmacist must direct the patient to the patient's
primary care provider. If the patient does not have a primary care provider, the pharmacist
must provide the patient with a list of local providers and clinics;
new text end

new text begin (2) does not report any signs or symptoms of acute HIV infection on a self-reported
checklist of acute HIV infection signs and symptoms; and
new text end

new text begin (3) does not report taking any contraindicated medications.
new text end

new text begin (e) The pharmacist must provide counseling to the patient on the ongoing use of
preexposure prophylaxis. The counseling may include education on possible side effects,
safety during pregnancy and breastfeeding, adherence to recommended dosing, and the
importance of timely testing and treatment as applicable for HIV, renal function, hepatitis
B, hepatitis C, sexually transmitted diseases, and pregnancy for patients of childbearing
capacity. The pharmacist must inform the patient that the patient must be seen by a health
care provider to receive subsequent prescriptions of preexposure prophylaxis.
new text end

new text begin (f) After dispensing the preexposure prophylaxis to the patient, the pharmacist must,
with the patient's consent, inform the patient's primary care provider that the pharmacist
has dispensed preexposure prophylaxis to the patient and has provided the required counseling
in accordance with paragraph (e). If the patient does not have a primary care provider or
refuses consent to notify the patient's primary care provider, the pharmacist must provide
the patient with a list of providers to contact regarding ongoing care for preexposure
prophylaxis. The pharmacist must maintain a record of the services provided to the patient
and of the preexposure prophylaxis dispensed to the patient. The record must be maintained
in the same manner required for prescription drug orders dispensed under this section.
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 HIV postexposure prophylaxis. new text end

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

new text begin (1) "postexposure prophylaxis" means any of the following:
new text end

new text begin (i) tenofovir disoproxil fumarate (TDF) (300 milligrams) with emtricitabine (FTC) (200
milligrams), taken once daily, in combination with either raltegravir (400 milligrams), taken
twice daily, or dolutegravir (50 milligrams), taken once daily;
new text end

new text begin (ii) tenofovir disoproxil fumarate (TDF) (300 milligrams) and emtricitabine (FTC) (200
milligrams), taken once daily, in combination with darunavir (800 milligrams) and ritonavir
(100 milligrams), taken once daily; or
new text end

new text begin (iii) another drug or drug combination determined by the board to meet the same clinical
eligibility recommendations provided in the CDC guidelines; and
new text end

new text begin (2) "CDC guidelines" means the "Updated Guidelines for Antiretroviral Postexposure
Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to
HIV-United States, 2016" or any subsequent guidelines published by the CDC.
new text end

new text begin (b) A pharmacist may dispense a postexposure prophylaxis without a prescription drug
order in accordance with this subdivision.
new text end

new text begin (c) Before dispensing a postexposure prophylaxis to a patient, a pharmacist must complete
a training program approved by the board on the use of preexposure prophylaxis and
postexposure prophylaxis. The training program must include information about financial
assistance programs for preexposure prophylaxis and postexposure prophylaxis, including
patient assistance programs offered by drug manufacturers and the AIDS drug assistance
program administered by the Department of Human Services. The board must approve a
training program in consultation with the Board of Medical Practice, the commissioners of
human services and health, and other relevant stakeholders by January 1, 2021.
new text end

new text begin (d) If a pharmacist completes the training program required under paragraph (c), the
pharmacist may dispense a complete course of postexposure prophylaxis to a patient after
the pharmacist:
new text end

new text begin (1) screens the patient and determines that exposure occurred within the previous 72
hours and the patient meets the clinical criteria for postexposure prophylaxis consistent with
CDC guidelines; and
new text end

new text begin (2) provides HIV testing to the patient that is classified as waived under the federal
Clinical Laboratory Improvement Amendments of 1988 (United States Code, title 42, section
263a) or the pharmacist determines that the patient is willing to undergo HIV testing
consistent with CDC guidelines. If the patient refuses to undergo HIV testing but is otherwise
eligible for postexposure prophylaxis under this subdivision, the pharmacist may dispense
postexposure prophylaxis to the patient.
new text end

new text begin (e) The pharmacist must provide counseling to the patient on the use of postexposure
prophylaxis consistent with CDC guidelines. The counseling may include education on
possible side effects, safety during pregnancy and breastfeeding, adherence to recommended
dosing, and the importance of timely testing and treatment for HIV and sexually transmitted
diseases. The pharmacist must inform the patient of the availability of preexposure
prophylaxis for individuals who are at substantial risk of acquiring HIV.
new text end

new text begin (f) After dispensing the postexposure prophylaxis to the patient, the pharmacist must,
with the patient's consent, inform the patient's primary care provider of the postexposure
prophylaxis treatment. If the patient does not have a primary care provider, or refuses consent
to notify the patient's primary care provider, the pharmacist must provide the patient with
a list of providers to contact regarding follow up care for postexposure prophylaxis. The
pharmacist must maintain a record of the services provided to the patient and the postexposure
prophylaxis dispensed to the patient. The record must be maintained in the same manner
required for prescription drug orders dispensed under this section.
new text end

Sec. 7.

Minnesota Statutes 2019 Supplement, section 214.122, is amended to read:


214.122 INFORMATION PROVISION; PHARMACEUTICAL ASSISTANCE
PROGRAMS.

(a) The Board of Medical Practice and the Board of Nursing shall at least annually inform
licensees who are authorized to prescribe prescription drugs of the availability of the Board
of Pharmacy's website that contains information on resources and programs to assist patients
with the cost of prescription drugs. The boards shall provide licensees with the website
address established by the Board of Pharmacy under section 151.06, subdivision 6, and the
materials described under section 151.06, subdivision 6, paragraph (b).

(b) Licensees must make available to patients information on sources of lower cost
prescription drugs, including information on the availability of the website established by
the Board of Pharmacy under section 151.06, subdivision 6.

new text begin (c) The Board of Medical Practice and the Board of Nursing shall ensure that licensees
are provided with information regarding the availability of preexposure or postexposure
prophylaxis if the licensee has patients who are at high risk for HIV or may have been
potentially exposed to HIV.
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 preexposure prophylaxis
dispensed by a licensed pharmacist in accordance with section 151.37, subdivision 14, and
postexposure prophylaxis dispensed by a licensed pharmacist in accordance with section
151.37, subdivision 15.
new text end