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SF 1129

1st Engrossment - 93rd Legislature (2023 - 2024) Posted on 06/29/2023 03:58pm

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

Current Version - 1st Engrossment

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A bill for an act
relating to human services; modifying the membership of the Formulary Committee;
modifying prior authorization requirements; modifying the procedure for making
changes to the preferred drug list; making related changes; amending Minnesota
Statutes 2022, section 256B.0625, subdivisions 13c, 13f, 13g.

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

Section 1.

Minnesota Statutes 2022, section 256B.0625, subdivision 13c, is amended to
read:


Subd. 13c.

Formulary Committee.

The commissioner, after receiving recommendations
from professional medical associations and professional pharmacy associations, and consumer
groups shall designate a Formulary Committee to carry out duties as described in subdivisions
13 to 13g. The Formulary Committee shall be comprised of deleted text begin fourdeleted text end new text begin at least fivenew text end licensed
physicians actively engaged in the practice of medicine in Minnesota, one of whom deleted text begin must
be actively engaged in the treatment of persons with mental illness
deleted text end new text begin is an actively practicing
psychiatrist, one of whom specializes in the diagnosis and treatment of rare diseases, one
of whom specializes in pediatrics, and one of whom actively treats persons with disabilities
new text end ;
at least three licensed pharmacists actively engaged in the practice of pharmacy in Minnesotanew text begin ,
one of whom practices outside the metropolitan counties listed in section 473.121, subdivision
4, one of whom practices in the metropolitan counties listed in section 473.121, subdivision
4, and one of whom is a practicing hospital pharmacist
new text end ; deleted text begin and onedeleted text end new text begin at least fournew text end consumer
deleted text begin representativedeleted text end new text begin representatives, all of whom must have a personal or professional connection
to medical assistance
new text end ; new text begin and one representative designated by the Minnesota Rare Disease
Advisory Council established under section 256.4835;
new text end the remainder to be made up of health
care professionals who are licensed in their field and have recognized knowledge in the
clinically appropriate prescribing, dispensing, and monitoring of covered outpatient drugs.
Members of the Formulary Committee shall not be employed by the Department of Human
Services, but the committee shall be staffed by an employee of the department who shall
serve as an ex officio, nonvoting member of the committee. The department's medical
director shall also serve as an ex officio, nonvoting member for the committee. Committee
members shall serve three-year terms and may be reappointed new text begin once new text end by the commissioner.
new text begin The committee members shall vote on a chair from among their membership. The chair
shall preside over all committee meetings.
new text end The Formulary Committee shall meet at least
deleted text begin twicedeleted text end new text begin four timesnew text end per year. The commissioner may require more frequent Formulary
Committee meetings as needed. An honorarium of $100 per meeting and reimbursement
for mileage shall be paid to each committee member in attendance. new text begin The Formulary Committee
is subject to the Open Meeting Law under chapter 13D.
new text end The Formulary Committee expires
June 30, deleted text begin 2023deleted text end new text begin 2027new text end .

Sec. 2.

Minnesota Statutes 2022, section 256B.0625, subdivision 13f, is amended to read:


Subd. 13f.

Prior authorization.

(a) The Formulary Committee shall review and
recommend drugs which require prior authorization. The Formulary Committee shall
establish general criteria to be used for the prior authorization of brand-name drugs for
which generically equivalent drugs are available, but the committee is not required to review
each brand-name drug for which a generically equivalent drug is available.

(b) Prior authorization may be required by the commissioner before certain formulary
drugs are eligible for payment. The Formulary Committee may recommend drugs for prior
authorization directly to the commissioner. The commissioner may also request that the
Formulary Committee review a drug for prior authorization. Before the commissioner may
require prior authorization for a drug:

(1) the commissioner must provide information to the Formulary Committee on the
impact that placing the drug on prior authorization may have on the quality of patient care
and on program costs, information regarding whether the drug is subject to clinical abuse
or misuse, and relevant data from the state Medicaid program if such data is available;

(2) the Formulary Committee must review the drug, taking into account medical and
clinical data and the information provided by the commissioner; and

(3) the Formulary Committee must hold a public forum and receive public comment for
an additional 15 days.

The commissioner must provide a 15-day notice period before implementing the prior
authorization.

(c) Except as provided in subdivision 13j, prior authorization shall not be required or
utilized for any atypical antipsychotic drug prescribed for the treatment of mental illness
if:

(1) there is no generically equivalent drug available; and

(2) the drug was initially prescribed for the recipient prior to July 1, 2003; or

(3) the drug is part of the recipient's current course of treatment.

This paragraph applies to any multistate preferred drug list or supplemental drug rebate
program established or administered by the commissioner. Prior authorization shall
automatically be granted for 60 days for brand name drugs prescribed for treatment of mental
illness within 60 days of when a generically equivalent drug becomes available, provided
that the brand name drug was part of the recipient's course of treatment at the time the
generically equivalent drug became available.

(d) new text begin Prior authorization shall not be required or utilized for:
new text end

new text begin (1) any liquid form of a medication for a patient who utilizes tube feedings of any kind,
even if such patient has or had any paid claims for pills; and
new text end

new text begin (2) liquid methadone. If more than one version of liquid methadone is available, the
commissioner shall select the version of liquid methadone that does not require prior
authorization.
new text end

new text begin This paragraph applies to any multistate preferred drug list or supplemental drug rebate
program established or administered by the commissioner.
new text end

new text begin (e) new text end The commissioner may require prior authorization for brand name drugs whenever
a generically equivalent product is available, even if the prescriber specifically indicates
"dispense as written-brand necessary" on the prescription as required by section 151.21,
subdivision 2
.

deleted text begin (e)deleted text end new text begin (f)new text end Notwithstanding this subdivision, the commissioner may automatically require
prior authorization, for a period not to exceed 180 days, for any drug that is approved by
the United States Food and Drug Administration on or after July 1, 2005. The 180-day
period begins no later than the first day that a drug is available for shipment to pharmacies
within the state. The Formulary Committee shall recommend to the commissioner general
criteria to be used for the prior authorization of the drugs, but the committee is not required
to review each individual drug. In order to continue prior authorizations for a drug after the
180-day period has expired, the commissioner must follow the provisions of this subdivision.

deleted text begin (f)deleted text end new text begin (g)new text end Prior authorization under this subdivision shall comply with section 62Q.184.

deleted text begin (g)deleted text end new text begin (h)new text end Any step therapy protocol requirements established by the commissioner must
comply with section 62Q.1841.

Sec. 3.

Minnesota Statutes 2022, section 256B.0625, subdivision 13g, is amended to read:


Subd. 13g.

Preferred drug list.

(a) The commissioner shall adopt and implement a
preferred drug list by January 1, 2004. The commissioner may enter into a contract with a
vendor for the purpose of participating in a preferred drug list and supplemental rebate
program. new text begin The terms of the contract with the vendor must be publicly disclosed on the website
of the Department of Human Services.
new text end The commissioner shall ensure that any contract
meets all federal requirements and maximizes federal financial participation. The
commissioner shall publish the preferred drug list annually in the State Register and shall
maintain an accurate and up-to-date list on the agency website.new text begin The commissioner shall
implement and maintain an accurate archive of previous versions of the preferred drug list,
and make this archive available to the public on the website of the Department of Human
Services beginning January 1, 2024.
new text end

(b) The commissioner may add to, delete from, and otherwise modify the preferred drug
list, after consulting with the Formulary Committee deleted text begin anddeleted text end new text begin ,new text end appropriate medical specialistsnew text begin ,
appropriate patient advocacy groups, and the Minnesota Rare Disease Advisory Council,
new text end
deleted text begin anddeleted text end providing public notice and the opportunity for public commentnew text begin , and complying with
the requirements of paragraph (f)
new text end .

(c) The commissioner shall adopt and administer the preferred drug list as part of the
administration of the supplemental drug rebate program. Reimbursement for prescription
drugs not on the preferred drug list may be subject to prior authorization.

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

new text begin (1) "appropriate medical specialist" means a medical professional who prescribes the
relevant class of drug as part of their subspecialty;
new text end

new text begin (2) "patient advocacy group" means a nonprofit organization as described in United
States Code, title 26, section 501(c)(3), that is exempt from income tax under section 501(a),
or a public entity that supports persons with the disease state treated by the therapeutic class
of the preferred drug list being updated; and
new text end

new text begin (3) new text end "preferred drug list" means a list of prescription drugs within designated therapeutic
classes selected by the commissioner, for which prior authorization based on the identity
of the drug or class is not required.

(e) The commissioner shall seek any federal waivers or approvals necessary to implement
this subdivision.new text begin The commissioner shall maintain a public list of applicable patient advocacy
groups.
new text end

(f) deleted text begin Notwithstanding paragraph (b),deleted text end Before the commissioner may delete a drug from the
preferred drug list or modify the inclusion of a drug on the preferred drug list, the
commissioner shall consider any implications that the deletion or modification may have
on state public health policies or initiatives and any impact that the deletion or modification
may have on increasing health disparities in the state. Prior to deleting a drug or modifying
the inclusion of a drug, the commissioner shall also conduct a public hearing. The
commissioner shall provide adequate notice to the public and the commissioner of health
prior to the hearing that specifies the drug that the commissioner is proposing to delete or
modify, new text begin and shall disclose new text end any deleted text begin publicdeleted text end medical or clinical analysis that the commissioner
has relied on in proposing the deletion or modification, and evidence that the commissioner
has evaluated the impact of the proposed deletion or modification on public health and
health disparities.new text begin Notwithstanding section 331A.05, a public notice of a Formulary
Committee meeting must be published at least 30 days in advance of the meeting. The list
of drugs to be discussed at the meeting must be announced at least 30 days before the meeting
and must include the name and class of drug, the proposed action, and the proposed prior
authorization requirements, if applicable.
new text end