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SF 3019

4th Engrossment - 91st Legislature (2019 - 2020) Posted on 03/12/2020 02:47pm

KEY: stricken = removed, old language.
underscored = added, new language.
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A bill for an act
relating to health care; establishing an insulin safety net program; requiring health
plan companies to provide notice to enrollees with dependent child coverage when
that coverage ends; appropriating money; amending Minnesota Statutes 2019
Supplement, sections 151.06, subdivision 6; 214.122; proposing coding for new
law in Minnesota Statutes, chapters 62Q; 151.

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

Section 1.

new text begin [62Q.678] DEPENDENT CHILD NOTICE.
new text end

new text begin Group health plans and health plan companies that offer group or individual health plans
with dependent coverage must provide written notice to an enrollee with dependent-child
coverage that the dependent child's coverage ends when the child reaches the age of 26.
Notice must be sent to the enrollee at the enrollee's last known address at least 60 days
before the dependent child reaches the age of 26. The notice must include the date on which
coverage ends and information on accessing the MNsure website as applicable.
new text end

Sec. 2.

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) new text beginthe insulin safety net program established in section 151.74, including information
on how to access the program;
new text end

new text begin (3) new text endthe prescription drug assistance program established by the Minnesota Board of
Aging under section 256.975, subdivision 9;

deleted text begin (3)deleted text end new text begin(4) new text endthe 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;

deleted text begin (4)deleted text end new text begin(5) new text endavailability of providers that are authorized to participate under section 340b of
the federal Public Health Services Act, United States Code, title 42, section 256b;

deleted text begin (5)deleted text end new text begin(6) new text endhaving 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; and

deleted text begin (6)deleted 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. 3.

new text begin [151.74] INSULIN SAFETY NET PROGRAM.
new text end

new text begin Subdivision 1. new text end

new text begin Establishment. new text end

new text begin (a) By July 1, 2020, each manufacturer must establish
procedures to make insulin available in accordance with this section to eligible individuals
who are in urgent need of insulin or who are in need of access to an affordable insulin
supply.
new text end

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

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

new text begin (2) "navigator" has the meaning provided in section 62V.02; and
new text end

new text begin (3) "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.
new text end

new text begin (c) Any manufacturer with an annual gross revenue of $2,000,000 or less from 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.
new text end

new text begin Subd. 2. new text end

new text begin Eligibility for urgent-need safety net program. new text end

new text begin (a) To be eligible to receive
an urgent-need supply of insulin under this section, an individual must attest to:
new text end

new text begin (1) being a resident of Minnesota;
new text end

new text begin (2) not being enrolled in medical assistance or MinnesotaCare;
new text end

new text begin (3) not having access to prescription drug coverage that limits the total amount of
cost-sharing that the enrollee is required to pay for a 30-day supply of insulin, including
co-payments, deductibles, or coinsurance, to $75 or less, regardless of the type or amount
of insulin prescribed;
new text end

new text begin (4) not having received an urgent-need supply of insulin through this program within
the previous 12 months; and
new text end

new text begin (5) being in urgent need of insulin.
new text end

new text begin (b) For purposes of this subdivision, "urgent need of insulin" means having readily
available for use less than a seven-day supply of insulin and in need of insulin in order to
avoid the likelihood of suffering significant health consequences.
new text end

new text begin Subd. 3. new text end

new text begin Pharmacy duties; access to urgent-need insulin. new text end

new text begin (a) An individual in urgent
need of insulin may present themselves to a pharmacy for the purpose of receiving an
urgent-need supply of insulin.
new text end

new text begin (b) The individual must:
new text end

new text begin (1) attest to the pharmacist that the individual meets the eligibility requirements described
in subdivision 2;
new text end

new text begin (2) have a valid insulin prescription; and
new text end

new text begin (3) present the pharmacist with identification indicating Minnesota residency in the form
of a valid Minnesota identification card, driver's license, or permit. If the individual in urgent
need of insulin is under the age of 18, the individual's parent or legal guardian must provide
the pharmacist with proof of residency.
new text end

new text begin (c) Upon receipt of the information described in paragraph (b), the pharmacist shall
dispense the prescribed insulin in an amount that is equivalent to a 30-day supply. The
pharmacy must notify the health care practitioner who issued the prescription order no later
than 72 hours after the insulin is dispensed.
new text end

new text begin (d) The pharmacy shall submit to the manufacturer of the dispensed insulin product a
claim for payment in accordance with the claims processing requirements agreed to by the
pharmacy and the manufacturer. The manufacturer shall reimburse the pharmacy for the
insulin dispensed in an amount that at least covers the pharmacy's acquisition cost for the
dispensed insulin, or may supply the pharmacy with the insulin product in the amount that
was dispensed.
new text end

new text begin (e) The pharmacy may collect an insulin co-payment from the individual in an amount
not to exceed $75 for the 30-day supply of insulin dispensed.
new text end

new text begin (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 is in need of accessing ongoing insulin coverage
options, including:
new text end

new text begin (1) assistance in applying for medical assistance or MinnesotaCare;
new text end

new text begin (2) assistance in applying for a qualified health plan offered through MNsure, subject
to open and special enrollment periods;
new text end

new text begin (3) providing 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
new text end

new text begin (4) assistance in accessing insulin manufacturers' patient assistance programs, co-payment
assistance programs, and other foundation-based programs.
new text end

new text begin Subd. 4. new text end

new text begin Continuing safety net program; general. new text end

new text begin (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 24-hour, seven days a
week contact information for individuals to call for assistance in accessing the program.
new text end

new text begin (b) To be eligible to participate in a manufacturer's patient assistance program, the
individual must:
new text end

new text begin (1) be a Minnesota resident;
new text end

new text begin (2) have a family income that is equal to or less than 400 percent of the federal poverty
guidelines;
new text end

new text begin (3) not be enrolled in medical assistance or MinnesotaCare;
new text end

new text begin (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
new text end

new text begin (5) not have access to 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 insulin, including co-payments, deductibles, or coinsurance to $75 or less,
regardless of the type or amount of insulin needed.
new text end

new text begin (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).
new text end

new text begin (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 insulin supply solution, including assistance in applying to a
manufacturer's patient assistance program.
new text end

new text begin Subd. 5. new text end

new text begin Continuing safety net program; manufacturer's responsibilities. new text end

new text begin (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.
new text end

new text begin (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.
new text end

new text begin (c) If the eligible individual has prescription drug coverage through an individual or
group health plan, the manufacturer may determine that the individual's 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.
new text end

new text begin Subd. 6. new text end

new text begin Continuing safety net program; process. new text end

new text begin (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 insulin product and the daily dosage amount as contained
in a valid prescription to the product's manufacturer.
new text end

new text begin (b) The pharmacy must include with the order to the manufacturer the following
information:
new text end

new text begin (1) the pharmacy's name and shipping address;
new text end

new text begin (2) office telephone number, fax number, e-mail address, and contact name; and
new text end

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

new text begin (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 insulin as ordered,
unless a lesser amount is requested in the order, at no charge to the individual or pharmacy.
new text end

new text begin (d) Except as authorized under paragraph (e), the pharmacy shall provide the insulin to
the individual at no charge to the individual. The pharmacy shall not provide 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 insulin received from the
manufacturer or from any third-party payer.
new text end

new text begin (e) The pharmacy may charge the individual a co-payment not to exceed $25 for each
90-day supply if the insulin is sent to the pharmacy.
new text end

new text begin (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.
new text end

new text begin (g) Notwithstanding paragraph (c), a manufacturer may send the insulin as ordered
directly to the individual if the manufacturer provides a mail order service option.
new text end

new text begin Subd. 7. new text end

new text begin Board of Pharmacy and MNsure responsibilities. new text end

new text begin (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:
new text end

new text begin (1) a description of the urgent-need insulin safety net program, including how to access
the program;
new text end

new text begin (2) a description of each insulin manufacturer's patient assistance program and
cost-sharing assistance program, including 24-hour, seven days a week contact information
on accessing the assistance programs for each manufacturer;
new text end

new text begin (3) information on how to contact a trained navigator for assistance in applying for
medical assistance, MinnesotaCare, a qualified health plan, or an insulin manufacturer's
patient assistance programs; and
new text end

new text begin (4) 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
insulin options.
new text end

new text begin (b) The board shall also inform each individual who accesses urgent-need 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).
new text end

new text begin (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
insulin options.
new text end

new text begin (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 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
insulin.
new text end

new text begin (e) If a navigator assists an individual in accessing an insulin manufacturer's patient
assistance program, MNsure, within the available appropriation, shall pay the navigator a
onetime application assistance bonus of $25. If a navigator receives an assistance bonus or
other compensation under section 62V.05, subdivision 4, or 256.962, subdivision 5, the
navigator shall not receive compensation under this paragraph.
new text end

new text begin Subd. 8. new text end

new text begin Dispute resolution. new text end

new text begin (a) If an individual disagrees with a manufacturer's
determination of eligibility under subdivision 5, the individual may contact the Board of
Pharmacy to request the use of a three-person panel to review eligibility. The panel shall
be composed of three persons designated by the board. The panel shall be provided with
all documents submitted by the individual to the manufacturer. The panel must render a
decision within ten business days and the decision of the panel is final.
new text end

new text begin (b) If the panel determines that the individual is eligible, the manufacturer shall provide
the individual with an eligibility statement in accordance with subdivision 5.
new text end

new text begin Subd. 9. new text end

new text begin Penalty. new text end

new text begin If a manufacturer fails to comply with this section, the board may
assess an administrative penalty of up to $100,000 for each year of noncompliance. Any
penalty assessed under this subdivision shall be deposited in a separate account in the special
revenue fund.
new text end

new text begin Subd. 10. new text end

new text begin Reports. new text end

new text begin (a) By February 15 of each year, beginning February 15, 2021, each
manufacturer shall report to the Board of Pharmacy the following:
new text end

new text begin (1) the number of Minnesota residents who accessed and received insulin on an
urgent-need basis under this section in the preceding calendar year;
new text end

new text begin (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
new text end

new text begin (3) the value of the insulin provided by the manufacturer under clauses (1) and (2).
new text end

new text begin For purposes of this paragraph, "value" means the wholesale acquisition cost of the insulin
provided.
new text end

new text begin (b) By March 15 of each year, beginning March 15, 2021, 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 9, including the name of the manufacturer and amount of the penalty
assessed.
new text end

new text begin Subd. 11. new text end

new text begin Program review; legislative auditor. new text end

new text begin The legislative auditor is requested to
conduct a program review to determine:
new text end

new text begin (1) whether the manufacturers are meeting the responsibilities required under this section,
including but not limited to:
new text end

new text begin (i) reimbursing pharmacies under subdivision 3;
new text end

new text begin (ii) determining eligibility in a timely manner and notifying the individuals as required
under subdivision 5; and
new text end

new text begin (iii) providing pharmacies with insulin product under the manufacturers' patient assistance
program;
new text end

new text begin (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; and
new text end

new text begin (3) the effectiveness of the manufacturers' public awareness campaigns in terms of what
each campaign involved, its focus, and to the extent practicable, whether it was successful.
new text end

new text begin Subd. 12. new text end

new text begin Program satisfaction; surveys. new text end

new text begin (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 manufacturers' 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.
new text end

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

new text begin (1) accessibility to urgent-need insulin;
new text end

new text begin (2) adequacy of the information sheet and list of navigators received from the pharmacy;
new text end

new text begin (3) whether the individual contacted a navigator and, if so, if the navigator was helpful
and knowledgeable;
new text end

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

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

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

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

new text begin (2) ease in submitting insulin product orders to the manufacturers; and
new text end

new text begin (3) timeliness of receiving insulin orders from the manufacturers.
new text end

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

new text begin (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.
new text end

new text begin Subd. 13. new text end

new text begin Sunset. new text end

new text begin This section expires December 31, 2023, except final reports required
to be submitted under subdivision 10 must be submitted as required by February 15, 2024,
and March 15, 2024.
new text end

Sec. 4.

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).new text begin The boards shall
also ensure that licensees are provided with information on the insulin safety net program
established in section 151.74, and a link to the Board of Pharmacy's information sheet on
how patients can apply for the program.
new text end

(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.

Sec. 5. new text beginPUBLIC AWARENESS CAMPAIGN.
new text end

new text begin (a) Each insulin manufacturer defined under Minnesota Statutes, section 151.74,
subdivision 1, shall conduct a public awareness campaign to create awareness of the insulin
safety net program established under Minnesota Statutes, section 151.74, and on the
availability of the manufacturer's patient assistance programs. The campaign must include
a contact number for individuals to call if an individual is in urgent need of insulin or in
need of accessing ongoing affordable insulin options.
new text end

new text begin (b) Before conducting the public awareness campaign described in paragraph (a), each
manufacturer shall submit to the commissioner of health a description of the proposed
campaign. The commissioner shall review each proposal and provide assistance and necessary
suggestions to ensure that the campaign accomplishes the intended purpose.
new text end

Sec. 6. new text beginSEVERABILITY.
new text end

new text begin If any provision of this act is found to be unconstitutional or void, the remaining
provisions of this act are valid.
new text end

Sec. 7. new text beginAPPROPRIATIONS.
new text end

new text begin (a) $250,000 is appropriated in fiscal year 2020 from the health care access fund to the
Board of Directors of MNsure to train navigators to assist individuals and provide
compensation as required under Minnesota Statutes, section 151.74, subdivision 7. Of this
appropriation, $108,000 is for implementing the training requirements for navigators and
$142,000 is for application assistance bonus payments. This is a onetime appropriation and
is available until December 31, 2023.
new text end

new text begin (b) $76,000 is appropriated in fiscal year 2021 from the health care access fund to the
Board of Pharmacy to implement Minnesota Statutes, section 151.74. The base for this
appropriation is $76,000 in fiscal year 2022; $76,000 in fiscal year 2023; $38,000 in fiscal
year 2024; and $0 in fiscal year 2025.
new text end

new text begin (c) $136,000 in fiscal year 2021 is appropriated from the health care access fund to the
commissioner of health to implement the survey to assess program satisfaction in Minnesota
Statutes, section 151.74, subdivision 12. The base for this appropriation is $80,000 in fiscal
year 2022 and $0 in fiscal year 2023. This is a onetime appropriation.
new text end