SF 17

as introduced - 91st Legislature, 2020 3rd Special Session (2020 - 2020) Posted on 08/13/2020 08:55am

A bill for an act
relating to health care; establishing an insulin registration fee; modifying the Alec
Smith Insulin Affordability Act; appropriating money; amending Laws 2020,
chapter 73, section 4, subdivisions 3, as amended, 6.

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

Section 1.

Laws 2020, chapter 73, section 4, subdivision 3, as amended by Laws 2020,
chapter 115, article 3, section 37, is amended to read:

Subd. 3.

Access to urgent-need insulin.

(a) MNsure shall develop an application form
to be used by an individual who is in urgent need of 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 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 insulin, the individual may present a completed,
signed, and dated application form to a pharmacy. The individual must also:

(1) have a valid 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, or tribal identification
card as defined in section 171.072, paragraph (b). 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.

(c) Upon receipt of a completed and signed application, the pharmacist shall dispense
the prescribed 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 insulin is dispensed.

(d) The pharmacy may submit to the manufacturer of the dispensed 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 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 an 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 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 is in need of accessing ongoing 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 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.

new text begin (h) A manufacturer may submit to the commissioner of administration a request for
reimbursement of payments paid to pharmacies under paragraph (d). The commissioner of
administration shall reimburse the manufacturer for each request submitted by the
manufacturer and received by the commissioner. The commissioner shall determine the
manner and format for submitting and processing requests for reimbursement.
new text end

new text begin EFFECTIVE DATE. new text end

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

Sec. 2.

Laws 2020, chapter 73, section 4, 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 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) office telephone number, fax number, e-mail 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 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 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.

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

new text begin (h) A manufacturer may submit to the commissioner of administration a request for
reimbursement for the insulin provided by the manufacturer in accordance with this
subdivision. The amount reimbursed to the manufacturer must be equivalent to the actual
acquisition cost of the insulin provided. The commissioner of administration shall reimburse
the manufacturer for each request submitted by the manufacturer and received by the
commissioner. The commissioner shall determine the manner and format for submitting
and processing requests for reimbursement.
new text end

new text begin EFFECTIVE DATE. new text end

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

Sec. 3. new text begin 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) "Board" means the Minnesota Board of Pharmacy established in Minnesota Statutes,
section 151.02.
new text end

new text begin (c) "Manufacturer" means a manufacturer licensed under Minnesota Statutes, section
151.252, and engaged in the manufacturing of insulin.
new text end

new text begin (d) "Wholesaler" means a wholesale drug distributor licensed under Minnesota Statutes,
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 September 1, 2020, each manufacturer and
each wholesaler must report to the board every sale, delivery, or other distribution of insulin
within or into the state that was made to any practitioner, pharmacy, or other person who
is permitted by Minnesota Statutes, section 151.37, to possess insulin for outpatient
dispensing to human patients during calendar year 2019. Reporting must be in the manner
and format specified by the board.
new text end

new text begin (b) By September 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 calendar year 2019. 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 the information required
under this subdivision 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 subdivision 5.
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 assess
manufacturers a onetime registration fee that in aggregate equals a total of $3,000,000. The
board shall determine for each manufacturer a prorated insulin registration fee that is based
on the manufacturer's percentage of the total number of units reported to the board under
subdivision 2.
new text end

new text begin (b) By November 1, 2020, the board shall notify each manufacturer of the amount of
the manufacturer's insulin registration fee to be paid in accordance with subdivision 4.
new text end

new text begin (c) A manufacturer may dispute the fee assessed under this subdivision as determined
by the board no later than 30 days after the date of notification. 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 original fee was correct, the manufacturer must remit the registration
fee as required under subdivision 4. 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) adjust the manufacturer's fee; 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 totals the amount specified in paragraph (a).
new text end

new text begin (d) Notwithstanding paragraph (c), if a manufacturer fails to provide information required
under subdivision 2 on a timely basis, the board may set the 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
calendar year 2019.
new text end

new text begin Subd. 4. new text end

new text begin Payment of the insulin registration fee. new text end

new text begin Each manufacturer must pay to the
board the applicable insulin registration fee determined under subdivision 3 by March 1,
2021. In the event of a change in ownership of the manufacturer, the new owner must pay
the registration fee determined under subdivision 3 that the original owner would have been
assessed had it retained ownership. The board may assess a late fee of ten percent per month
or any portion of a month that the registration fee is paid after the due date. The registration
fee collected under this section, including any late fees collected under this section, shall
be deposited in the insulin assistance account established in subdivision 5.
new text end

new text begin Subd. 5. new text end

new text begin Insulin assistance account. new text end

new text begin (a) The insulin assistance account is established
in the special revenue fund in the state treasury. Money in the insulin account is appropriated
to the commissioner of administration to reimburse manufacturers for insulin dispensed
under the insulin safety net program established under Minnesota Statutes, section 151.74,
in accordance with Minnesota Statutes, section 151.74, subdivisions 3, paragraph (h), and
6, paragraph (h), and to cover costs incurred by the commissioner for providing these
reimbursement payments.
new text end

new text begin (b) The commissioner of management and budget shall transfer to the health care access
fund up to a total amount of $3,000,000 when there is a balance available in the insulin
assistance account.
new text end

new text begin (c) The commissioner of management and budget may transfer money from the health
care access fund to the insulin assistance account if the account has a deficiency.
new text end

new text begin (d) If there is a surplus in the insulin assistance account at the end of fiscal year 2021,
the surplus is appropriated to the board and shall be refunded by the board to the
manufacturers proportionally to each manufacturer's share of the total registration fee
payment.
new text end

new text begin EFFECTIVE DATE. new text end

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

Sec. 4. new text begin TRANSFER.
new text end

new text begin In fiscal year 2021, the commissioner of management and budget shall transfer $3,000,000
from the health care access fund to the insulin assistance 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