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HF 3144

as introduced - 91st Legislature (2019 - 2020) Posted on 02/11/2020 03:35pm

KEY: stricken = removed, old language.
underscored = added, new language.
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16.5

A bill for an act
relating to health care; establishing an emergency insulin program; establishing a
Minnesota insulin patient assistance program; requiring participation by pharmacies
and insulin manufacturers; requiring reports; appropriating money; amending
Minnesota Statutes 2019 Supplement, sections 151.06, subdivision 6; 151.252,
subdivision 1; 214.122; proposing coding for new law in Minnesota Statutes,
chapters 16B; 62Q; 62V; 151.

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

Section 1.

new text begin [16B.992] EMERGENCY INSULIN ASSISTANCE PROGRAM.
new text end

new text begin Subdivision 1. new text end

new text begin Establishment. new text end

new text begin (a) The commissioner of administration shall implement
and administer an emergency insulin assistance program beginning July 1, 2020.
new text end

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

new text begin (1) "emergency program" or "program" means the emergency insulin assistance program
established under this section;
new text end

new text begin (2) "Minnesota insulin patient assistance program" means the program established under
section 62V.12; and
new text end

new text begin (3) "navigator" has the meaning provided in section 62V.02.
new text end

new text begin Subd. 2. new text end

new text begin Contract with third-party administrator. new text end

new text begin The commissioner may contract
with a third-party administrator to provide assistance in administering the program. The
initial negotiated contract is not subject to the requirements of chapter 16C. Any contract
with a third-party administrator must:
new text end

new text begin (1) require the third-party administrator to process insulin claims and pay participating
pharmacies for insulin that is dispensed by the participating pharmacy to individuals under
the program;
new text end

new text begin (2) prohibit the use of rebates; and
new text end

new text begin (3) require that all data be maintained as private by the third-party administrator and not
be shared with a third party without the patient's consent.
new text end

new text begin Subd. 3. new text end

new text begin Eligibility requirements. new text end

new text begin To be eligible for the program, an individual must
have a valid prescription for insulin and 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) having a tax household income that is equal to or less than 500 percent of the federal
poverty guidelines;
new text end

new text begin (4)(i) being uninsured;
new text end

new text begin (ii) having prescription drug coverage through Medicare and having incurred annual
out-of-pocket prescription drug costs that exceed $1,000; or
new text end

new text begin (iii) having private insurance coverage with cost sharing that exceeds $50 for a month's
supply of insulin, regardless of the amount or types of insulin needed;
new text end

new text begin (5) not being eligible to receive insulin through Indian Health Services and not being
enrolled in TRICARE or prescription drug benefits through the United States Department
of Veterans Affairs; and
new text end

new text begin (6) not having received insulin dispensed through the program during the 12 months
preceding the date of submission of the application.
new text end

new text begin Subd. 4. new text end

new text begin Application process. new text end

new text begin (a) The board of directors of MNsure and the
commissioner shall jointly develop an application form to be used for this program and the
Minnesota insulin patient assistance program established under section 62V.12. The
application must:
new text end

new text begin (1) require the applicant to indicate whether insulin is being requested on an emergency
basis; and
new text end

new text begin (2) provide for the applicant's consent to any transfer of personal data.
new text end

new text begin The commissioner and the board of directors of MNsure shall make the application form
available on their websites to pharmacies and to health care practitioners who are authorized
to prescribe, administer, or dispense insulin.
new text end

new text begin (b) An applicant must submit a signed and dated application form to the MNsure board
in order to obtain insulin under the program. By signing the application, applicants are
attesting that the information contained in the application is correct. An application for
emergency insulin may be submitted through the MNsure website or as a paper application
through a pharmacy. An individual is not eligible to reapply for the program until 12 months
have elapsed from the date insulin was first dispensed to the individual under the program,
at which time the individual must submit a new application form.
new text end

new text begin (c) Upon receipt of a completed and signed application, the MNsure board shall verify,
if applicable, whether 12 months have elapsed from the date insulin was first dispensed
under the program to the individual. The board shall provide applicants satisfying this
criterion and new applicants with an identification number, indicating that a completed
application has been received. The information must be provided in a format that can be
downloaded by the applicant or conveyed in an electronic format.
new text end

new text begin Subd. 5. new text end

new text begin Pharmacy participation. new text end

new text begin (a) Each pharmacy licensed under chapter 151 that
dispenses insulin must participate in the program as a condition of doing business in this
state.
new text end

new text begin (b) A pharmacy shall dispense up to a three-month supply of insulin to individuals who
present a valid prescription, completed application, and MNsure identification number, and
who have indicated that they need insulin on an emergency basis. A pharmacy shall dispense
insulin in one-month supply increments, upon the request of an eligible individual. Upon
dispensing insulin under the program, the pharmacy must submit a claim for reimbursement
to the commissioner, in the form and manner specified by the commissioner.
new text end

new text begin (c) A pharmacy must make program applications available at each pharmacy location
and may assist applicants in applying for the program.
new text end

new text begin (d) Eligible individuals are responsible for paying a co-payment to the participating
pharmacy of $30 for each month's supply of insulin, or a proportional co-payment for
quantities of insulin other than a month's supply, regardless of the amount or types of insulin
needed.
new text end

new text begin (e) When dispensing insulin to an eligible individual, a pharmacy must:
new text end

new text begin (1) provide the individual with the address for the website established under section
151.06, subdivision 6, paragraph (a); and
new text end

new text begin (2) provide the individual with information about the Minnesota insulin patient assistance
program established under section 62V.12.
new text end

new text begin Subd. 6. new text end

new text begin State and federal anti-kickback provisions. new text end

new text begin (a) The conduct of any person
or entity in participating in or administering the emergency insulin assistance program under
this section is not subject to liability under section 62J.23, subdivisions 1 and 2.
new text end

new text begin (b) No person or entity, including but not limited to any drug manufacturer, pharmacy,
pharmacist, or third-party administrator, as part of the person's or entity's participation in
or administration of the emergency insulin assistance program established under this section,
shall request or seek, or cause another to request or seek, any reimbursement or other
compensation for which payment may be made in whole or in part under a federal health
care program, as this term is defined in United States Code, title 42, section 1320a-7b(f).
new text end

new text begin Subd. 7. new text end

new text begin Report. new text end

new text begin By January 15, 2022, and by each January 15 thereafter, the
commissioner, in consultation with any third-party administrator under contract and the
board of directors of MNsure, 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 on the emergency insulin assistance program for the previous fiscal year,
including:
new text end

new text begin (1) the number of individuals who received insulin under the program;
new text end

new text begin (2) the cost of the program, with a separate statement of administrative costs; and
new text end

new text begin (3) the number of individuals who reapplied for the program.
new text end

Sec. 2.

new text begin [16B.993] INSULIN ASSISTANCE ACCOUNT.
new text end

new text begin Subdivision 1. new text end

new text begin Establishment. new text end

new text begin The insulin assistance account is established in the special
revenue fund in the state treasury. The fees collected by the Board of Pharmacy under section
151.252, subdivision 1, paragraph (c) shall be deposited into the account.
new text end

new text begin Subd. 2. new text end

new text begin Use of account funds. new text end

new text begin For fiscal year 2020 and subsequent fiscal years, money
in the insulin account is appropriated to:
new text end

new text begin (1) the commissioner of administration to reimburse pharmacies for insulin dispensed
under the emergency insulin program established under section 16B.992 and for related
administrative costs, including the cost of any contract with a third-party administrator; and
new text end

new text begin (2) the board of directors of MNsure to fund administrative costs incurred by the board
in operating the Minnesota insulin patient assistance program established under section
62V.12. The commissioner may also transfer money from the account to the health care
access fund, as required under this act.
new text end

Sec. 3.

new text begin [62Q.491] COST-SHARING LIMIT FOR INSULIN.
new text end

new text begin Subdivision 1. new text end

new text begin Applicability. new text end

new text begin This section applies to all health plans that provide coverage
for insulin.
new text end

new text begin Subd. 2. new text end

new text begin Limit on cost sharing. new text end

new text begin (a) All health plans included in subdivision 1 shall limit
any cost sharing for insulin to no more than $30 for a month's supply, or proportional cost
sharing for a quantity of insulin other than a month's supply, regardless of the amount or
types of insulin needed.
new text end

new text begin (b) Nothing in this subdivision prevents a health plan company from limiting cost sharing
for insulin under a health plan to an amount lower than that specified in paragraph (a).
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2021, and applies to health
plans offered, issued, or renewed on or after that date.
new text end

Sec. 4.

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 and to the dependent child covered under the enrollee's plan that the dependent
child's coverage ends when the child reaches the age of 26. Notice must be sent to both the
enrollee at the enrollee's last known address and the dependent child at the dependent child's
last known address at least 90 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.
new text end

Sec. 5.

new text begin [62V.12] MINNESOTA INSULIN PATIENT ASSISTANCE PROGRAM.
new text end

new text begin Subdivision 1. new text end

new text begin Establishment. new text end

new text begin The MNsure board shall implement and administer the
Minnesota insulin patient assistance program beginning July 1, 2020.
new text end

new text begin Subd. 2. new text end

new text begin Eligibility. new text end

new text begin (a) To be eligible for the Minnesota insulin patient assistance
program, an individual must have a valid prescription for insulin and:
new text end

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

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

new text begin (3) have a tax household income that is equal to or less than 400 percent of the federal
poverty guidelines;
new text end

new text begin (4)(i) be uninsured;
new text end

new text begin (ii) have prescription drug coverage through Medicare and have incurred annual
out-of-pocket drug costs that exceed $1,000; or
new text end

new text begin (iii) have private insurance coverage with cost sharing that exceeds $50 for a month's
supply of insulin, regardless of the amount or types of insulin needed; and
new text end

new text begin (5) not be eligible to receive insulin through Indian Health Services and not be enrolled
in TRICARE or prescription drug benefits through the United States Department of Veterans
Affairs.
new text end

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

new text begin (1) "navigator" has the meaning provided in section 62V.02; and
new text end

new text begin (2) "program" means the Minnesota insulin patient assistance program established under
this section.
new text end

new text begin Subd. 3. new text end

new text begin Application process; eligibility determination. new text end

new text begin (a) The board shall make the
application form developed under section 16B.992, subdivision 4, available to pharmacies
and to health care practitioners who are authorized to prescribe, administer, or dispense
insulin. A participating pharmacy must make program applications available at each
pharmacy location. The application form must be accessible through the MNsure website.
An applicant may submit a signed and dated application form to the board through the
MNsure website, by mail or fax, or in person during normal business hours.
new text end

new text begin (b) The board shall develop and implement a process to determine if an individual is
eligible for the program. The process developed by the board may include the use of
navigators to assist the board in assessing qualifying criteria and assisting an individual in
understanding or applying for medical assistance, MinnesotaCare, the Minnesota insulin
patient assistance program, and other long-term insulin coverage options.
new text end

new text begin (c) Following receipt of a completed application submitted as specified under paragraph
(a) or transmitted as provided under section 16B.992, subdivision 4, the board must determine
eligibility for insulin coverage as provided in this subdivision. The board may require the
applicant to submit additional information to determine eligibility.
new text end

new text begin (d) The board shall first determine, using data provided by the commissioner of human
services, if the individual is enrolled in medical assistance or MinnesotaCare. If the board
determines that an individual is enrolled in one of these programs, the individual is not
eligible to participate in the Minnesota insulin patient assistance program. If the board
determines that an individual is not enrolled in medical assistance or MinnesotaCare, the
board shall refer the individual to a navigator for assistance.
new text end

new text begin (e) If an individual is referred to a navigator under paragraph (d), the navigator shall
screen the individual for eligibility for the Minnesota insulin patient assistance program
and shall notify the MNsure board for confirmation of the individual's eligibility. If the
board confirms that the individual is eligible, the board shall then:
new text end

new text begin (1) submit the individual's patient information to drug manufacturers as required by
subdivision 4; and
new text end

new text begin (2) inform the individual of and provide the individual with an eligibility statement. The
eligibility statement must identify the individual with a patient identification number.
new text end

new text begin (f) If the individual is not found eligible under paragraphs (d) and (e), the board shall
notify the individual that the individual may qualify for an insulin coverage option specified
in this paragraph and shall provide the individual with information on how to enroll in the
coverage option. Insulin coverage options include, but are not limited to:
new text end

new text begin (1) another insulin manufacturer patient assistance program;
new text end

new text begin (2) qualified health plans offered through MNsure, subject to open and special enrollment
periods;
new text end

new text begin (3) 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) community health centers.
new text end

new text begin (g) The eligibility statement is valid for 12 months from the date of issuance, after which
an individual must submit a new application form to continue to participate in the program.
new text end

new text begin (h) The MNsure board shall follow the process provided in Minnesota Rules, part
7700.0105, for individuals to appeal eligibility determinations under this section.
new text end

new text begin Subd. 4. new text end

new text begin Submittal to manufacturers. new text end

new text begin (a) The board must submit the eligible patient's
identification number and other relevant information to drug manufacturers in accordance
with this section.
new text end

new text begin (b) A patient participating in the program may elect to receive insulin from the
manufacturer assistance program through a community pharmacy, a mail-order pharmacy,
or a health care provider designated by the patient.
new text end

new text begin Subd. 5. new text end

new text begin Manufacturer's responsibilities. new text end

new text begin (a) Each manufacturer licensed under section
151.252 that is engaged in the manufacturing of insulin must participate in the program as
a condition of doing business in this state and must operate a patient insulin assistance
program that meets the patient eligibility and other requirements of this section. Each
manufacturer participating in the program must provide the board with a fax number, mailing
address, and e-mail address for a health care practitioner to use in submitting a prescription
order to the manufacturer. For purposes of this subdivision, a prescription order includes
the patient's name, identification number, prescription, and address to where the prescription
should be sent or picked up by the patient.
new text end

new text begin (b) Upon receipt of a prescription order from a health care practitioner and the information
described in subdivision 4, the manufacturer must send a three-month supply of the product
ordered, unless a lesser amount is requested in the order, to the pharmacy or health care
provider designated by the patient at no charge to the patient, pharmacy, or health care
provider.
new text end

new text begin (c) Upon receipt of each prescription reorder for a patient, the manufacturer must send
an additional 90-day supply of the product, unless a lesser amount is requested, to the
pharmacy or health care provider designated by the patient at no charge to the patient,
pharmacy, or health care provider.
new text end

new text begin (d) Each manufacturer participating in the program must annually report to the Board
of Pharmacy, in the form and manner specified by the board, information on the number of
individuals participating in the program and the quantity of insulin provided through the
program and other information necessary for the board to verify manufacturer compliance.
If a manufacturer fails to comply with the requirements of this section, the Board of Pharmacy
may assess an administrative penalty of up to $100,000 for each month or partial month
that a manufacturer is out of compliance. This penalty is not considered a form of disciplinary
action.
new text end

new text begin Subd. 6. new text end

new text begin Data. new text end

new text begin (a) All data collected, created, or maintained by the board under this
section related to applicants, eligible individuals, and program participants is private data
on individuals as defined in section 13.02, subdivision 12, but may be shared with
manufacturers participating in the program, but only with patient consent and to the extent
necessary for program operation.
new text end

new text begin (b) The commissioner of human services and the board of directors of MNsure may
enter into an information-sharing agreement for purposes of determining medical assistance
and MinnesotaCare enrollment status related to operation of the patient insulin assistance
program, provided the agreement includes adequate protections with respect to the
confidentiality and integrity of the information to be shared, and complies with all applicable
state and federal laws, regulations, and rules, including the requirements in section 62V.06.
new text end

new text begin Subd. 7. new text end

new text begin State and federal anti-kickback provisions. new text end

new text begin (a) The conduct of any person
or entity in participating in or administering the Minnesota insulin patient assistance program
under this section is not subject to liability under section 62J.23, subdivisions 1 and 2.
new text end

new text begin (b) No person or entity, including but not limited to any drug manufacturer, pharmacy,
pharmacist, or third-party administrator, as part of the person's or entity's participation in
or administration of the Minnesota insulin patient assistance program established under this
section, shall request or seek, or cause another to request or seek, any reimbursement or
other compensation for which payment may be made in whole or in part under a federal
health care program, as this term is defined in United States Code, title 42, section
1320a-7b(f).
new text end

new text begin Subd. 8. new text end

new text begin Report. new text end

new text begin (a) By January 15 of each year, beginning January 15, 2021, the board
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 on the program for the
previous calendar year. The report must provide a summary of the status of the program
and must include the number of individuals who received insulin under the program.
new text end

new text begin (b) By January 15 of each year, beginning January 15, 2021, the Board of Pharmacy
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 on the number of
individuals participating in a drug manufacturer insulin assistance program and the quantity
of insulin products provided through the programs in the aggregate and through each drug
manufacturer insulin assistance program. The board shall also include in the report an
evaluation of the extent to which drug manufacturer insulin assistance programs comply
with the eligibility and other requirements of this section.
new text end

Sec. 6.

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 emergency insulin assistance program established in section 16B.992 and the
Minnesota insulin patient assistance program established in section 62V.12, including
information on how to access each 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. 7.

new text begin [151.245] INSULIN REPORTING AND REGISTRATION FEE.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section, the following terms have
the meanings given them.
new text end

new text begin (b) "Manufacturer" means a manufacturer licensed under section 151.252 engaged in
the manufacturing of insulin.
new text end

new text begin (c) "Wholesaler" means a wholesale drug distributor licensed under section 151.47 and
engaged in the wholesale drug distribution of insulin.
new text end

new text begin Subd. 2. new text end

new text begin Reporting requirements. new text end

new text begin (a) By March 1 of each year, beginning March 1,
2020, each manufacturer and each wholesaler must report to the Board of Pharmacy every
sale, delivery, or other distribution of insulin within or into the state that was made to any
practitioner, pharmacy, hospital, or other person who is permitted by section 151.37 to
possess insulin for administration or dispensing to human patients during the previous
calendar year. Reporting must be in the manner and format specified by the board.
new text end

new text begin (b) By March 1 of each year, beginning March 1, 2020, each owner of a pharmacy with
at least one location within this state must report to the board any intracompany delivery
or distribution of insulin into this state, to the extent that those deliveries and distributions
are not reported to the board by a licensed wholesaler owned by, under contract to, or
otherwise operating on behalf of the owner of the pharmacy. Reporting must be in the
manner and format specified by the board for deliveries and distributions that occurred
during the previous calendar year. The report must include the name of the manufacturer
or wholesaler from which the owner of the pharmacy ultimately purchased the insulin and
the amount and date the purchase occurred.
new text end

new text begin (c) If the manufacturer, wholesaler, or pharmacy fails to provide information required
under this section on a timely basis, the board may assess an administrative penalty of up
to $10,000 per day. This penalty is not considered a form of disciplinary action. Any penalty
assessed under this section shall be deposited in the insulin assistance account established
under section 16B.993.
new text end

new text begin Subd. 3. new text end

new text begin Determination of manufacturer's registration fee. new text end

new text begin (a) The board shall annually
assess manufacturers a registration fee that in aggregate equals the total cost of:
new text end

new text begin (1) the emergency insulin assistance program established under section 16B.992 for the
previous fiscal year, including any state appropriation to the commissioner of administration
to reimburse pharmacies for insulin dispensed under the program and any administrative
costs incurred by the commissioner of administration, or incurred by the board in collecting
the fee, plus any outstanding liabilities to the program; and
new text end

new text begin (2) costs incurred by the board of directors of MNsure in administering the Minnesota
insulin patient assistance program established under section 62V.12.
new text end

new text begin The board shall determine for each manufacturer a prorated annual insulin registration fee
that is based on the manufacturer's percentage of the total number of units reported to the
board under subdivision 2. For the first assessment, the commissioner shall estimate the
cost of the program for the first fiscal year and notify the board of the estimated cost by
May 1, 2020. The board shall determine each manufacturer's initial registration fee based
on the estimated cost.
new text end

new text begin (b) By June 1 of each year, beginning June 1, 2020, the board shall notify each
manufacturer of the annual amount of the manufacturer's insulin registration fee to be paid
in accordance with section 151.252, subdivision 1, paragraph (c).
new text end

new text begin (c) A manufacturer may dispute the fee assessed under this section as determined by the
board no later than 30 days after the date of notification. However, the manufacturer must
still remit the registration fee required by section 151.252, subdivision 1, paragraph (c). The
dispute must be filed with the board in the manner and using the forms specified by the
board. A manufacturer must submit, with the required forms, data satisfactory to the board
that demonstrates that the fee was incorrect or otherwise unwarranted. The board must make
a decision concerning a dispute no later than 60 days after receiving the required dispute
forms. If the board determines that the manufacturer has satisfactorily demonstrated that
the original fee was incorrect, the board must:
new text end

new text begin (1)(i) adjust the manufacturer's fee;
new text end

new text begin (ii) adjust the manufacturer's fee due the next year by the amount in excess of the correct
fee that should have been paid; or
new text end

new text begin (iii) refund the amount paid in error; and
new text end

new text begin (2) adjust the fees of other manufacturers as needed to ensure that the registration fee
in the aggregate meets the requirements of paragraph (a).
new text end

new text begin (d) If a manufacturer fails to provide information required under subdivision 2 on a
timely basis, the board may set an annual insulin registration fee for that manufacturer,
taking into account that manufacturer's percentage of the total number of units of insulin
sold, delivered, or distributed under the medical assistance program during the previous
calendar year.
new text end

Sec. 8.

Minnesota Statutes 2019 Supplement, section 151.252, subdivision 1, is amended
to read:


Subdivision 1.

Requirements.

(a) No person shall act as a drug manufacturer without
first obtaining a license from the board and paying any applicable fee specified in section
151.065.

(b) In addition to the license required under paragraph (a), each manufacturer required
to pay the registration fee under section 151.066 must pay the fee by June 1 of each year,
beginning June 1, 2020. In the event of a change of ownership of the manufacturer, the new
owner must pay the registration fee specified under section 151.066, subdivision 3, that the
original owner would have been assessed had the original owner retained ownership. The
registration fee collected under this paragraph shall be deposited in the opiate epidemic
response account established under section 256.043.

new text begin (c) In addition to the license required under paragraph (a), a manufacturer of insulin
must pay the applicable insulin registration fee determined under section 151.245 by July
1 of each year, beginning July 1, 2020. In the event of a change of ownership of the
manufacturer, the new owner must pay the registration fee determined under section 151.245
that the original owner would have been assessed had it retained ownership. The board may
assess a late fee of ten percent per month for any portion of a month that the registration
fee is paid after the due date. The registration fee collected under this paragraph, including
any late fees, shall be deposited in the insulin assistance account established under section
16B.993.
new text end

deleted text begin (c)deleted text endnew text begin (d)new text end Application for a drug manufacturer license under this section shall be made in
a manner specified by the board.

deleted text begin (d)deleted text endnew text begin (e)new text end No license shall be issued or renewed for a drug manufacturer unless the applicant
agrees to operate in a manner prescribed by federal and state law and according to Minnesota
Rules.

deleted text begin (e)deleted text endnew text begin (f)new text end No license shall be issued or renewed for a drug manufacturer that is required to
be registered pursuant to United States Code, title 21, section 360, unless the applicant
supplies the board with proof of registration. The board may establish by rule the standards
for licensure of drug manufacturers that are not required to be registered under United States
Code, title 21, section 360.

deleted text begin (f)deleted text endnew text begin (g)new text end No license shall be issued or renewed for a drug manufacturer that is required to
be licensed or registered by the state in which it is physically located unless the applicant
supplies the board with proof of licensure or registration. The board may establish, by rule,
standards for the licensure of a drug manufacturer that is not required to be licensed or
registered by the state in which it is physically located.

deleted text begin (g)deleted text endnew text begin (h)new text end The board shall require a separate license for each facility located within the state
at which drug manufacturing occurs and for each facility located outside of the state at
which drugs that are shipped into the state are manufactured, except a manufacturer of
opiate-containing controlled substances shall not be required to pay the fee under section
151.065, subdivision 1, clause (16), or subdivision 3, clause (14), for more than one facility.

deleted text begin (h)deleted text endnew text begin (i)new text end Prior to the issuance of an initial or renewed license for a drug manufacturing
facility, the board may require the facility to pass a current good manufacturing practices
inspection conducted by an authorized representative of the board. In the case of a drug
manufacturing facility located outside of the state, the board may require the applicant to
pay the cost of the inspection, in addition to the license fee in section 151.065, unless the
applicant furnishes the board with a report, issued by the appropriate regulatory agency of
the state in which the facility is located or by the United States Food and Drug
Administration, of an inspection that has occurred within the 24 months immediately
preceding receipt of the license application by the board. The board may deny licensure
unless the applicant submits documentation satisfactory to the board that any deficiencies
noted in an inspection report have been corrected.

Sec. 9.

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 emergency insulin assistance
program established under section 16B.992 and the Minnesota insulin patient assistance
program established under section 62V.12, including health care practitioners' responsibilities
under the programs and how patients can apply for the programs.
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. 10. new text beginCITATION.
new text end

new text begin This act may be cited as "The Alec Smith Insulin Affordability Act."
new text end

Sec. 11. new text beginEARLIER IMPLEMENTATION DATE FOR THE EMERGENCY INSULIN
ASSISTANCE PROGRAM.
new text end

new text begin (a) The governor may direct by executive order the commissioner of administration to
begin operating the emergency insulin assistance program before the July 1, 2020,
implementation date, and may direct by executive order the MNsure board to begin operating
the Minnesota insulin patient assistance program before the July 1, 2020, implementation
date.
new text end

new text begin (b) If the governor does not issue an executive order under paragraph (a), the
commissioner of administration shall implement the emergency insulin assistance program
beginning July 1, 2020, as required under Minnesota Statutes, section 16B.992, and the
MNsure board shall implement the Minnesota insulin patient assistance program beginning
July 1, 2020, as required under Minnesota Statutes, section 62V.12.
new text end

Sec. 12. new text beginPUBLIC AWARENESS CAMPAIGN.
new text end

new text begin The board of directors of MNsure, in consultation with the commissioner of
administration, shall conduct a public awareness campaign to create awareness of the
emergency insulin assistance program established under Minnesota Statutes, section 16B.992,
and the Minnesota insulin patient assistance program established under Minnesota Statutes,
section 62V.12. The campaign must focus on educating eligible individuals in need of
assistance in purchasing insulin of the existence of the programs and on how to apply.
new text end

Sec. 13. new text beginAPPROPRIATION.
new text end

new text begin (a) $400,000 in fiscal year 2020 is appropriated from the health care access fund to the
commissioner of administration to implement and administer the emergency insulin assistance
program established under Minnesota Statutes, section 16B.992, including the cost of any
contract with a third-party administrator. This is a onetime appropriation.
new text end

new text begin (b) $250,000 in fiscal year 2020 is appropriated from the health care access fund to the
board of directors of MNsure for a public awareness campaign for the emergency insulin
assistance program established under Minnesota Statutes, section 16B.992 and the Minnesota
insulin patient assistance program established under Minnesota Statutes, section 62V.12.
This is a onetime appropriation.
new text end

new text begin (c) $250,000 in fiscal year 2020 is appropriated from the health care access fund to the
board of directors of MNsure for MNsure navigator training and reimbursement related to
the Minnesota insulin patient assistance program and the emergency insulin assistance
program. This appropriation is added to the base.
new text end

new text begin (d) $....... in fiscal year 2020 is appropriated from the health care access fund to the board
of directors of MNsure for administrative costs related to implementing the Minnesota
insulin patient assistance program established under Minnesota Statutes, section 62V.12,
and $....... in fiscal year 2020 is appropriated from the health care access fund to the
commissioner of administration for additional administrative costs related to the emergency
insulin program established under Minnesota Statutes, section 16B.992. These are onetime
appropriations. In fiscal year 2021, the commissioner of management and budget shall
transfer $....... from the insulin assistance account to the health care access fund.
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