SF 19

as introduced - 91st Legislature, 2020 5th Special Session (2020 - 2020) Posted on 10/13/2020 09:23am

A bill for an act
relating to health care; sunsetting the Drug Formulary Committee; requiring the
commissioner of human services to submit to the legislature a proposed
reformulation of the Drug Formulary Committee ensuring public input; requiring
the medical assistance drug formulary and preferred drug list to include any drug
that is FDA approved for the treatment or prevention of HIV/AIDS; requiring a
public hearing before a drug may be deleted from the preferred drug list; prohibiting
the deletion of a drug from the preferred drug list solely for economic or fiscal
reasons; amending Minnesota Statutes 2018, section 256B.0625, subdivisions 13c,
13d, 13g; Minnesota Statutes 2019 Supplement, section 256B.0625, subdivision
13f.

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

Section 1.

Minnesota Statutes 2018, 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 four licensed physicians actively
engaged in the practice of medicine in Minnesota one of whom must be actively engaged
in the treatment of persons with mental illness; at least three licensed pharmacists actively
engaged in the practice of pharmacy in Minnesota; and one consumer representative; 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 by the commissioner. The Formulary Committee shall meet at least twice 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. The Formulary Committee expires June 30, deleted text begin 2022 deleted text end new text begin
2021 new text end .

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 2.

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

Subd. 13d.

Drug formulary.

(a) The commissioner shall establish a drug formulary. Its
establishment and publication shall not be subject to the requirements of the Administrative
Procedure Act, but the Formulary Committee shall review and comment on the formulary
contents.

(b) The formulary shall not include:

(1) drugs, active pharmaceutical ingredients, or products for which there is no federal
funding;

(2) over-the-counter drugs, except as provided in subdivision 13;

(3) drugs or active pharmaceutical ingredients used for weight loss, except that medically
necessary lipase inhibitors may be covered for a recipient with type II diabetes;

(4) drugs or active pharmaceutical ingredients when used for the treatment of impotence
or erectile dysfunction;

(5) drugs or active pharmaceutical ingredients for which medical value has not been
established;

(6) drugs from manufacturers who have not signed a rebate agreement with the
Department of Health and Human Services pursuant to section 1927 of title XIX of the
Social Security Act; and

(7) medical cannabis as defined in section 152.22, subdivision 6.

(c) If a single-source drug used by at least two percent of the fee-for-service medical
assistance recipients is removed from the formulary due to the failure of the manufacturer
to sign a rebate agreement with the Department of Health and Human Services, the
commissioner shall notify prescribing practitioners within 30 days of receiving notification
from the Centers for Medicare and Medicaid Services (CMS) that a rebate agreement was
not signed.

new text begin (d) Notwithstanding any law to the contrary, the commissioner shall not remove from
the drug formulary any class of drugs that have been approved by the federal Food and Drug
Administration for the treatment or prevention of HIV/AIDs.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 3.

Minnesota Statutes 2019 Supplement, 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) 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.

(e) 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.

(f) Prior authorization under this subdivision shall comply with section 62Q.184.

(g) Any step therapy protocol requirements established by the commissioner must comply
with section 62Q.1841.

new text begin (h) Notwithstanding any law to the contrary, prior authorization shall not be required or
utilized for any class of drugs that are approved by the federal Food and Drug Administration
for the treatment or prevention of HIV/AIDs.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 4.

Minnesota Statutes 2018, 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. 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.

(b) The commissioner may add to, delete from, and otherwise modify the preferred drug
list, after consulting with the Formulary Committee and appropriate medical specialists and
providing public notice and the opportunity for public comment.

(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, "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 (f) Notwithstanding paragraph (b), 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, in consultation with the commissioner of health, shall consider any
implications the deletion or modification may have on state public health policies or
initiatives and any impact 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 providing adequate notice to the public
prior to the hearing that specifies the drug the commissioner is proposing to delete or modify,
any medical or clinical analysis that the commissioner has relied on in proposing the deletion
or modification, and evidence that the commissioner has consulted with the commissioner
of health and has evaluated the impact of the proposed deletion or modification on public
health and health disparities. No drug shall be deleted from the preferred drug list solely
based on economic or fiscal reasons.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 5. new text begin PROPOSED DRUG FORMULARY COMMITTEE.
new text end

new text begin By March 1, 2021, the commissioner of human services, in consultation with relevant
professional associations and consumer groups, shall submit to the chairs and ranking
minority members of the legislative committees with jurisdiction over health and human
services a proposed reformulation of the Drug Formulary Committee that includes:
new text end

new text begin (1) the proposed membership of the committee, including adequate representation of
consumers and health care professionals with expertise in clinical prescribing; and
new text end

new text begin (2) proposed policies and procedures for the operation of the committee that ensures
public input, including providing public notice and gathering public comments on the
committee's recommendations and proposed actions.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end