Definition for covered insulin for the insulin safety net program and manufacturer registration fee provision

A bill for an act

relating to health; providing a definition for covered insulin for the insulin safety

net program and manufacturer registration fee; amending Minnesota Statutes 2024,

sections 13.381, subdivision 20; 151.74, subdivisions 1, 2, 3, 4, 5, 6, 7, 9, 10, 11,

13, 14; 151.741, subdivisions 1, 2; Minnesota Statutes 2025 Supplement, section

151.741, subdivision 5; repealing Minnesota Statutes 2024, section 151.74,

subdivision 15.

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

Section 1.

Minnesota Statutes 2024, section 13.381, subdivision 20, is amended to read:

Subd. 20.

Insulin safety net.

Data collected relating to an individual who seeks to access

urgent-need
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covered
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insulin or participates in a manufacturer's patient assistance program

is classified under section
151.74, subdivision 11
.

Sec. 2.

Minnesota Statutes 2024, section 151.74, subdivision 1, is amended to read:

Subdivision 1.

Establishment.

(a)
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By July 1, 2020,
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Each manufacturer must establish

procedures to make
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covered
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insulin available in accordance with this section to eligible

individuals who are in urgent need of
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covered
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insulin or who are in need of access to an

affordable
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covered
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insulin supply.

(b) For purposes of this section, the following definitions apply:

(1) "manufacturer" means a manufacturer engaged in the manufacturing of
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covered
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insulin
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that is self-administered on an outpatient basis
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;

(2) "MNsure" means the Board of Directors of MNsure established in chapter 62V;

(3) "navigator" has the meaning provided in section
62V.02
;
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and
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(4) "pharmacy" means a pharmacy located in Minnesota and licensed under section

151.19
that operates in the community or outpatient license category under Minnesota Rules,

part
6800.0350
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.
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; and
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(5) "covered insulin" means a drug that is validly prescribed by a practitioner and contains

insulin for use to treat diabetes. Covered insulin does not include an insulin product with a

label approved by the United States Food and Drug Administration that indicates the product

is only for use for intravenous infusion.

new text end

(c) Any manufacturer with an annual gross revenue of $2,000,000 or less from
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covered
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insulin sales in Minnesota is exempt from this section. To request a waiver under this

paragraph, the manufacturer must submit a request to the Board of Pharmacy that includes

documentation indicating that the manufacturer is eligible for an exemption.

(d)
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An
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A covered
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insulin product is exempt from this section if the wholesale acquisition

cost of the
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covered
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insulin is $8 or less per milliliter or applicable National Council for

Prescription Drug Plan billing unit, for the entire assessment time period, adjusted annually

based on the Consumer Price Index.

Sec. 3.

Minnesota Statutes 2024, section 151.74, subdivision 2, is amended to read:

Subd. 2.

Eligibility for urgent-need safety net program.

(a) To be eligible to receive

an urgent-need supply of
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covered
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insulin under this section, an individual must attest to:

(1) being a resident of Minnesota;

(2) not being enrolled in medical assistance or MinnesotaCare;

(3) not being enrolled in prescription drug coverage that limits the total amount of

cost-sharing that the enrollee is required to pay for a 30-day supply of
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covered
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insulin,

including co-payments, deductibles, or coinsurance, to $75 or less, regardless of the type

or amount of
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covered
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insulin prescribed;

(4) not having received an urgent-need supply of
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covered
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insulin through this program

within the previous 12 months, unless authorized under subdivision 9; and

(5) being in urgent need of
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covered
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insulin.

(b) For purposes of this subdivision, "urgent need of
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covered
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insulin" means having

readily available for use less than a seven-day supply of
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covered
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insulin and in need of
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covered
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insulin in order to avoid the likelihood of suffering significant health consequences.

Sec. 4.

Minnesota Statutes 2024, section 151.74, subdivision 3, is amended to read:

Subd. 3.

Access to urgent-need
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covered
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insulin.

(a) MNsure shall develop an application

form to be used by an individual who is in urgent need of
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covered
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insulin. The application

must ask the individual to attest to the eligibility requirements described in subdivision 2.

The form shall be accessible through MNsure's website. MNsure shall also make the form

available to pharmacies and health care providers who prescribe or dispense
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covered
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insulin,

hospital emergency departments, urgent care clinics, and community health clinics. By

submitting a completed, signed, and dated application to a pharmacy, the individual attests

that the information contained in the application is correct.

(b) If the individual is in urgent need of
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covered
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insulin, the individual may present a

completed, signed, and dated application form to a pharmacy. The individual must also:

(1) have a
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valid
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covered
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insulin prescription; and

(2) present the pharmacist with identification indicating Minnesota residency in the form

of a valid Minnesota identification card, driver's license or permit, individual taxpayer

identification number, or Tribal identification card as defined in section
171.072
, paragraph

(b). If the individual in urgent need of
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covered
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insulin is under the age of 18, the individual's

parent or legal guardian must provide the pharmacist with proof of residency.

(c) Upon receipt of a completed and signed application, the pharmacist shall dispense

the
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prescribed
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covered
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insulin in an amount that will provide the individual with a 30-day

supply. The pharmacy must notify the health care practitioner who issued the prescription

order no later than 72 hours after the
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covered
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insulin is dispensed.

(d) The pharmacy may submit to the manufacturer of the dispensed
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covered
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insulin

product or to the manufacturer's vendor a claim for payment that is in accordance with the

National Council for Prescription Drug Program standards for electronic claims processing,

unless the manufacturer agrees to send to the pharmacy a replacement supply of the same
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covered
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insulin as dispensed in the amount dispensed. If the pharmacy submits an electronic

claim to the manufacturer or the manufacturer's vendor, the manufacturer or vendor shall

reimburse the pharmacy in an amount that covers the pharmacy's acquisition cost.

(e) The pharmacy may collect
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an
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a covered
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insulin co-payment from the individual to

cover the pharmacy's costs of processing and dispensing in an amount not to exceed $35

for the 30-day supply of
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covered
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insulin dispensed.

(f) The pharmacy shall also provide each eligible individual with the information sheet

described in subdivision 7 and a list of trained navigators provided by the Board of Pharmacy

for the individual to contact if the individual needs to access ongoing
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covered
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insulin

coverage options, including assistance in:

(1) applying for medical assistance or MinnesotaCare;

(2) applying for a qualified health plan offered through MNsure, subject to open and

special enrollment periods;

(3) accessing information on providers who participate in prescription drug discount

programs, including providers who are authorized to participate in the 340B program under

section 340b of the federal Public Health Services Act, United States Code, title 42, section

256b; and

(4) accessing
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covered
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insulin manufacturers' patient assistance programs, co-payment

assistance programs, and other foundation-based programs.

(g) The pharmacist shall retain a copy of the application form submitted by the individual

to the pharmacy for reporting and auditing purposes.

(h) A manufacturer may submit to the commissioner of administration a request for

reimbursement in an amount not to exceed $35 for each 30-day supply of
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covered
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insulin

the manufacturer provides under paragraph (d). The commissioner of administration shall

determine the manner and format for submitting and processing requests for reimbursement.

After receiving a reimbursement request, the commissioner of administration shall reimburse

the manufacturer in an amount not to exceed $35 for each 30-day supply of
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covered
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insulin

the manufacturer provided under paragraph (d).

Sec. 5.

Minnesota Statutes 2024, section 151.74, subdivision 4, is amended to read:

Subd. 4.

Continuing safety net program; general.

(a) Each manufacturer shall make

a patient assistance program available to any individual who meets the requirements of this

subdivision. Each manufacturer's patient assistance programs must meet the requirements

of this section. Each manufacturer shall provide the Board of Pharmacy with information

regarding the manufacturer's patient assistance program, including contact information for

individuals to call for assistance in accessing their patient assistance program.

(b) To be eligible to participate in a manufacturer's patient assistance program, the

individual must:

(1) be a Minnesota resident with a valid Minnesota identification card that indicates

Minnesota residency in the form of a Minnesota identification card, driver's license or

permit, individual taxpayer identification number, or Tribal identification card as defined

in section
171.072
, paragraph (b). If the individual is under the age of 18, the individual's

parent or legal guardian must provide proof of residency;

(2) have a family income that is equal to or less than 400 percent of the federal poverty

guidelines;

(3) not be enrolled in medical assistance or MinnesotaCare;

(4) not be eligible to receive health care through a federally funded program or receive

prescription drug benefits through the Department of Veterans Affairs; and

(5) not be enrolled in prescription drug coverage through an individual or group health

plan that limits the total amount of cost-sharing that an enrollee is required to pay for a

30-day supply of
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covered
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insulin, including co-payments, deductibles, or coinsurance to

$75 or less, regardless of the type or amount of
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covered
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insulin needed.

(c) Notwithstanding the requirement in paragraph (b), clause (4), an individual who is

enrolled in Medicare Part D is eligible for a manufacturer's patient assistance program if

the individual has spent $1,000 on prescription drugs in the current calendar year and meets

the eligibility requirements in paragraph (b), clauses (1) to (3).

(d) An individual who is interested in participating in a manufacturer's patient assistance

program may apply directly to the manufacturer; apply through the individual's health care

practitioner, if the practitioner participates; or contact a trained navigator for assistance in

finding a long-term
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covered
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insulin supply solution, including assistance in applying to a

manufacturer's patient assistance program.

Sec. 6.

Minnesota Statutes 2024, section 151.74, subdivision 5, is amended to read:

Subd. 5.

Continuing safety net program; manufacturer's responsibilities.

(a) Upon

receipt of an application for the manufacturer's patient assistance program, the manufacturer

shall process the application and determine eligibility. The manufacturer shall notify the

applicant of the determination within ten business days of receipt of the application. If

necessary, the manufacturer may request additional information from the applicant. If

additional information is needed, the manufacturer must notify the applicant within five

business days of receipt of the application as to what information is being requested. Within

three business days of receipt of the requested information, the manufacturer must determine

eligibility and notify the applicant of the determination. If the individual has been determined

to be not eligible, the manufacturer must include the reasons for denying eligibility in the

notification. The individual may seek an appeal of the determination in accordance with

subdivision 8.

(b) If the individual is determined to be eligible, the manufacturer shall provide the

individual with an eligibility statement or other indication that the individual has been

determined eligible for the manufacturer's patient assistance program. An individual's

eligibility is valid for 12 months and is renewable upon a redetermination of eligibility.

(c) If the eligible individual has prescription drug coverage through an individual or

group health plan, the manufacturer may determine that the individual's
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covered
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insulin

needs are better addressed through the use of the manufacturer's co-payment assistance

program, in which case, the manufacturer shall inform the individual and provide the

individual with the necessary coupons to submit to a pharmacy. In no instance shall an

eligible individual be required to pay more than the co-payment amount specified under

subdivision 6, paragraph (e).

Sec. 7.

Minnesota Statutes 2024, section 151.74, subdivision 6, is amended to read:

Subd. 6.

Continuing safety net program; process.

(a) The individual shall submit to

a pharmacy the statement of eligibility provided by the manufacturer under subdivision 5,

paragraph (b). Upon receipt of an individual's eligibility status, the pharmacy shall submit

an order containing the name of the
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covered
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insulin product and the daily dosage amount

as contained in a valid prescription to the product's manufacturer.

(b) The pharmacy must include with the order to the manufacturer the following

information:

(1) the pharmacy's name and shipping address;

(2) the pharmacy's office telephone number, fax number, email address, and contact

name; and

(3) any specific days or times when deliveries are not accepted by the pharmacy.

(c) Upon receipt of an order from a pharmacy and the information described in paragraph

(b), the manufacturer shall send to the pharmacy a 90-day supply of
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covered
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insulin as

ordered, unless a lesser amount is requested in the order, at no charge to the individual or

pharmacy.

(d) Except as authorized under paragraph (e), the pharmacy shall provide the
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covered
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insulin to the individual at no charge to the individual. The pharmacy shall not provide
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covered
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insulin received from the manufacturer to any individual other than the individual

associated with the specific order. The pharmacy shall not seek reimbursement for the
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covered
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insulin received from the manufacturer or from any third-party payer.

(e) The pharmacy may collect a co-payment from the individual to cover the pharmacy's

costs for processing and dispensing in an amount not to exceed $50 for each 90-day supply

if the
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covered
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insulin is sent to the pharmacy.

(f) The pharmacy may submit to a manufacturer a reorder for an individual if the

individual's eligibility statement has not expired. Upon receipt of a reorder from a pharmacy,

the manufacturer must send to the pharmacy an additional 90-day supply of the product,

unless a lesser amount is requested, at no charge to the individual or pharmacy if the

individual's eligibility statement has not expired.

(g) Notwithstanding paragraph (c), a manufacturer may send the
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covered
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insulin as

ordered directly to the individual if the manufacturer provides a mail order service option.

(h) A manufacturer may submit to the commissioner of administration a request for

reimbursement in an amount not to exceed $105 for each 90-day supply of
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covered
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insulin

the manufacturer provides under paragraphs (c) and (f). The commissioner of administration

shall determine the manner and format for submitting and processing requests for

reimbursement. After receiving a reimbursement request, the commissioner of administration

shall reimburse the manufacturer in an amount not to exceed $105 for each 90-day supply

of
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covered
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insulin the manufacturer provided under paragraphs (c) and (f). If the manufacturer

provides less than a 90-day supply of
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covered
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insulin under paragraphs (c) and (f), the

manufacturer may submit a request for reimbursement not to exceed $35 for each 30-day

supply of
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covered
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insulin provided.

Sec. 8.

Minnesota Statutes 2024, section 151.74, subdivision 7, is amended to read:

Subd. 7.

Board of Pharmacy and MNsure responsibilities.

(a) The Board of Pharmacy

shall develop an information sheet to post on its website and provide a link to the information

sheet on the board's website for pharmacies, health care practitioners, hospital emergency

departments, urgent care clinics, and community health clinics. The information sheet must

contain:

(1) a description of the urgent-need
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covered
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insulin safety net program, including how

to access the program;

(2) a description of each
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covered
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insulin manufacturer's patient assistance program and

cost-sharing assistance program, including contact information on accessing the assistance

programs for each manufacturer;

(3) information on how to contact a trained navigator for assistance in applying for

medical assistance, MinnesotaCare, a qualified health plan, or
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an
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a covered
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insulin

manufacturer's patient assistance programs;

(4) information on how to contact the Board of Pharmacy if a manufacturer determines

that an individual is not eligible for the manufacturer's patient assistance program; and

(5) notification that an individual in need of assistance may contact their local county

social service department for more information or assistance in accessing ongoing affordable
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covered
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insulin options.

(b) The board shall also inform each individual who accesses urgent-need
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covered
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insulin

through the insulin safety net program or accesses a manufacturer's patient assistance program

that the individual may participate in a survey conducted by the Department of Health

regarding satisfaction with the program. The board shall provide contact information for

the individual to learn more about the survey and how to participate. This information may

be included on the information sheet described in paragraph (a).

(c) MNsure, in consultation with the Board of Pharmacy and the commissioner of human

services, shall develop a training program for navigators to provide navigators with

information and resources necessary to assist individuals in accessing appropriate long-term
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covered
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insulin options.

(d) MNsure, in consultation with the Board of Pharmacy, shall compile a list of navigators

who have completed the training program and who are available to assist individuals in

accessing affordable
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covered
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insulin coverage options. The list shall be made available

through the board's website and to pharmacies and health care practitioners who dispense

and prescribe
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covered
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insulin.

(e) If a navigator assists an individual in accessing
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an
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a covered
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insulin manufacturer's

patient assistance program, MNsure, within the available appropriation, shall pay the

navigator a onetime application assistance bonus of no less than $25. If a navigator receives

a payment per enrollee of an assistance bonus under section
62V.05, subdivision 4
, or

256.962
, subdivision 5, the navigator shall not receive compensation under this paragraph.

Sec. 9.

Minnesota Statutes 2024, section 151.74, subdivision 9, is amended to read:

Subd. 9.

Additional 30-day urgent-need
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covered
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insulin supply.

(a) If an individual

has applied for medical assistance or MinnesotaCare but has not been determined eligible

or has been determined eligible but coverage has not become effective or the individual has

been determined ineligible for the manufacturer's patient assistance program by the

manufacturer and the individual has requested a review pursuant to subdivision 8 but the

panel has not rendered a decision, the individual may access urgent-need
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covered
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insulin

under subdivision 3 if the individual is in urgent need of
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covered
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insulin as defined under

subdivision 2, paragraph (b).

(b) To access an additional 30-day supply of
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covered
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insulin, the individual must attest

to the pharmacy that the individual meets the requirements of paragraph (a) and must comply

with subdivision 3, paragraph (b).

Sec. 10.

Minnesota Statutes 2024, section 151.74, subdivision 10, is amended to read:

Subd. 10.

Penalty.

(a) If a manufacturer fails to comply with this section, the board may

assess an administrative penalty of $200,000 per month of noncompliance, with the penalty

increasing to $400,000 per month if the manufacturer continues to be in noncompliance

after six months, and increasing to $600,000 per month if the manufacturer continues to be

in noncompliance after one year. The penalty shall remain at $600,000 per month for as

long as the manufacturer continues to be in noncompliance.

(b) In addition, a manufacturer is subject to the administrative penalties specified in

paragraph (a) if the manufacturer fails to:

(1) provide a hotline for individuals to call or access between 8 a.m. and 10 p.m. on

weekdays and between 10 a.m. and 6 p.m. on Saturdays; and

(2) list on the manufacturer's website the eligibility requirements for the manufacturer's

patient assistance programs for Minnesota residents.

(c) Any penalty assessed under this subdivision shall be deposited in a separate
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covered
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insulin assistance account in the special revenue fund.

Sec. 11.

Minnesota Statutes 2024, section 151.74, subdivision 11, is amended to read:

Subd. 11.

Data.

(a) Any data collected, created, received, maintained, or disseminated

by the Board of Pharmacy, the legislative auditor, the commissioner of health, MNsure, or

a trained navigator under this section related to an individual who is seeking to access

urgent-need
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covered
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insulin or participate in a manufacturer's patient assistance program

under this section is classified as private data on individuals as defined in section
13.02,

subdivision
12, and may not be retained for longer than ten years.

(b) A manufacturer must maintain the privacy of all data received from any individual

applying for the manufacturer's patient assistance program under this section and is prohibited

from selling, sharing, or disseminating data received under this section unless required to

under this section or the individual has provided the manufacturer with a signed authorization.

Sec. 12.

Minnesota Statutes 2024, section 151.74, subdivision 13, is amended to read:

Subd. 13.

Reports.

(a) By February 15 of each year,
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beginning February 15, 2021,
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each

manufacturer shall report to the Board of Pharmacy the following:

(1) the number of Minnesota residents who accessed and received
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covered
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insulin on

an urgent-need basis under this section in the preceding calendar year;

(2) the number of Minnesota residents participating in the manufacturer's patient

assistance program in the preceding calendar year, including the number of Minnesota

residents who the manufacturer determined were ineligible for their patient assistance

program; and

(3) the value of the
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covered
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insulin provided by the manufacturer under clauses (1) and

(2).

For purposes of this paragraph, "value" means the wholesale acquisition cost of the
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covered
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insulin provided.

(b) By March 15 of each year,
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beginning March 15, 2021,
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the Board of Pharmacy shall

submit the information reported in paragraph (a) to the chairs and ranking minority members

of the legislative committees with jurisdiction over health and human services policy and

finance. The board shall also include in the report any administrative penalties assessed

under subdivision 10, including the name of the manufacturer and amount of the penalty

assessed.

Sec. 13.

Minnesota Statutes 2024, section 151.74, subdivision 14, is amended to read:

Subd. 14.

Program review; legislative auditor.

(a) The legislative auditor is requested

to conduct a program review to determine:

(1) whether the manufacturers are meeting the responsibilities required under this section,

including but not limited to:

(i) reimbursing pharmacies for urgent-need
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covered
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insulin dispensed under subdivision

3;

(ii) determining eligibility in a timely manner and notifying the individuals as required

under subdivision 5; and

(iii) providing pharmacies with
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covered
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insulin product under the manufacturers' patient

assistance programs; and

(2) whether the training program developed for navigators is adequate and easily

accessible for navigators interested in becoming trained, and that there is a sufficient number

of trained navigators to provide assistance to individuals in need of assistance.

(b) The legislative auditor may access application forms retained by pharmacies under

subdivision 3, paragraph (g), to determine whether urgent-need
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covered
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insulin is being

dispensed in accordance with this section.

Sec. 14.

Minnesota Statutes 2024, section 151.741, subdivision 1, is amended to read:

Subdivision 1.

Definitions.

(a) For purposes of this section, the following terms have

the meanings given.

(b) "Board" means the Minnesota Board of Pharmacy under section
151.02
.

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(c) "Covered insulin" has the meaning given in section 151.74, subdivision 1.

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(c)
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(d)
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"Manufacturer" means a manufacturer licensed under section
151.252
and engaged

in the manufacturing of
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prescription
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covered
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insulin.

Sec. 15.

Minnesota Statutes 2024, section 151.741, subdivision 2, is amended to read:

Subd. 2.

Assessment of registration fee.

(a) The board shall assess each manufacturer

an annual registration fee of $100,000, except as provided in paragraph (b). The board shall

notify each manufacturer of this requirement beginning November 1, 2024, and each

November 1 thereafter.

(b) A manufacturer may request an exemption from the annual registration fee. The

board shall exempt a manufacturer from the annual registration fee if the manufacturer can

demonstrate to the board, in the form and manner specified by the board, that gross revenue

from sales of
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prescription
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covered
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insulin produced by that manufacturer and sold or

delivered within or into Minnesota was less than five percent of the total gross revenue from

sales of
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prescription
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covered
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insulin produced by all manufacturers and sold or delivered

within or into Minnesota in the previous calendar year.

Sec. 16.

Minnesota Statutes 2025 Supplement, section 151.741, subdivision 5, is amended

to read:

Subd. 5.

Insulin repayment account; annual transfer from health care access fund.

(a)

The insulin repayment account is established in the special revenue fund in the state treasury.

Money in the account is appropriated each fiscal year to the commissioner of administration

to reimburse manufacturers for
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covered
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insulin dispensed under the insulin safety net program

in section
151.74
, in accordance with section
151.74, subdivisions 3
, paragraph (h), and 6,

paragraph (h), and to cover costs incurred by the commissioner in providing these

reimbursement payments.

(b) By June 30, 2025, and each June 30 thereafter, the commissioner of administration

shall certify to the commissioner of management and budget the total amount expended in

the prior fiscal year for:

(1) reimbursement to manufacturers for
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covered
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insulin dispensed under the insulin

safety net program in section
151.74
, in accordance with section
151.74, subdivisions 3
,

paragraph (h), and 6, paragraph (h); and

(2) costs incurred by the commissioner of administration in providing the reimbursement

payments described in clause (1).

(c) The commissioner of management and budget shall transfer from the health care

access fund to the insulin repayment account, beginning July 1, 2025, and each July 1

thereafter, an amount equal to the amount to which the commissioner of administration

certified pursuant to paragraph (b).

Sec. 17.
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REPEALER.
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Minnesota Statutes 2024, section 151.74, subdivision 15,

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is repealed.

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APPENDIX

Repealed Minnesota Statutes: 26-06583

151.74 INSULIN SAFETY NET PROGRAM.

Subd. 15.

Program satisfaction; surveys.

(a) The commissioner of health, in consultation with the Board of Pharmacy and individuals who are insulin-dependent, shall develop and conduct a survey of individuals who have accessed urgent-need insulin through the program and who are accessing or have accessed a manufacturer's patient assistance program since the commencement of the insulin safety net program; and a survey of pharmacies that have dispensed insulin on an urgent-need basis under the program and have participated in the manufacturers' patient assistance programs under this section.

(b) The survey for individuals shall cover overall satisfaction with the program, including but not limited to:

(1) accessibility to urgent-need insulin;

(2) adequacy of the information sheet and list of navigators received from the pharmacy;

(3) whether the individual contacted a trained navigator and, if so, if the navigator was helpful and knowledgeable;

(4) whether the individual accessed the manufacturer's patient assistance program and, if so, how easy it was to access application forms, apply to the manufacturer's programs, and receive the insulin product from the pharmacy; and

(5) whether the individual is still in need of a long-term solution for affordable insulin.

(c) The survey for the pharmacies shall include, but is not limited to:

(1) timeliness of reimbursement from the manufacturers for urgent-need insulin dispensed by the pharmacy;

(2) ease in submitting insulin product orders to the manufacturers; and

(3) timeliness of receiving insulin orders from the manufacturers.

(d) The commissioner may contract with a nonprofit entity to develop and conduct the survey and to evaluate the survey results.

(e) By January 15, 2022, the commissioner shall submit a report to the chairs and ranking minority members of the legislative committees with jurisdiction over health and human services policy and finance containing the results of the surveys.