SF 472

as introduced - 91st Legislature (2019 - 2020) Posted on 01/24/2019 03:09pm

A bill for an act
relating to human services; establishing an insulin assistance program; establishing
the insulin assistance account in the special revenue fund; requiring drug
manufacturers to pay an insulin product fee; providing for emergency refills;
appropriating money; amending Minnesota Statutes 2018, sections 151.252,
subdivision 1; 151.37, by adding a subdivision; proposing coding for new law in
Minnesota Statutes, chapters 151; 256.

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

Section 1. new text begin CITATION.
new text end

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

Sec. 2.

Minnesota Statutes 2018, 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) Application for a drug manufacturer license under this section shall be made in a
manner specified by the board.

(c) 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.

(d) 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.

(e) 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.

(f) 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.

(g) The board shall not issue an initial or renewed license for a drug manufacturing
facility unless the facility passes an 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.

new text begin (h) The board shall not issue a renewed license for a drug manufacturer unless the
manufacturer pays any insulin product fee it is required to pay under section 151.2521.
new text end

Sec. 3.

new text begin [151.2521] INSULIN PRODUCT FEE.
new text end

new text begin Subdivision 1. new text end

new text begin Insulin product fee established. new text end

new text begin (a) A manufacturer licensed under
section 151.252 that holds a Food and Drug Administration approved New Drug Application,
or approved Abbreviated New Drug Application, for any qualified insulin product, shall
pay to the Board of Pharmacy an insulin product fee as specified in this section.
new text end

new text begin (b) For purposes of this section, a "qualified insulin product" means any prescription
product containing insulin for which the board determines the wholesale acquisition cost
of the drug, or other relevant measure of drug cost, exceeds the national average for
comparable prescription products containing insulin.
new text end

new text begin Subd. 2. new text end

new text begin Reporting requirements. new text end

new text begin (a) Effective December 1, 2019, a manufacturer
licensed under section 151.252 shall provide the board with data about each of its prescription
products that contain insulin that are sold within this state. The data shall include, for each
product, the trade and generic names, strength, package size, and National Drug Code. A
manufacturer required to report this data shall also report a billing address to which the
board can send invoices and inquiries related to the insulin product fee. A manufacturer
shall notify the board of any change to this data no later than 30 days after the change is
made. The board may require a manufacturer to confirm the accuracy of the data on a
quarterly basis. If a manufacturer fails to provide information required under this paragraph
on a timely basis, the board may assess an administrative penalty of $100 per day. This
penalty shall not be considered a form of disciplinary action.
new text end

new text begin (b) Effective February 1, 2020, a manufacturer licensed under section 151.252 or a
wholesaler licensed under section 151.47 shall report to the board every sale, delivery, or
other distribution within or into this state of any prescription product containing insulin that
is made to any practitioner, pharmacy, or hospital. Reporting shall be in the Automation of
Reports and Consolidated Orders System format unless otherwise specified by the board,
and shall occur by the 15th day of each calendar month, for sales, deliveries, and other
distributions that occurred during the previous calendar month, except that the first report
submitted to the board shall include data retroactive to July 1, 2019. If a manufacturer or
wholesaler fails to provide information required under this paragraph on a timely basis, the
board may assess an administrative penalty of $100 per day. This penalty shall not be
considered a form of disciplinary action.
new text end

new text begin (c) Effective February 1, 2020, any pharmacy licensed under section 151.19 and located
outside of this state, including but not limited to community, long-term care, mail order,
and compounding and central service pharmacies, must report the dispensing of prescription
products that contain insulin to patients located within this state. Reporting shall be in the
manner and format specified by the board, and shall occur by the 15th day of each month,
for dispensing that occurred during the previous calendar month, except that the first report
submitted to the board shall include data retroactive to July 1, 2019. If a pharmacy fails to
provide information required under this paragraph on a timely basis, the board may assess
an administrative penalty of $100 per day. This penalty shall not be considered a form of
disciplinary action.
new text end

new text begin (d) Effective February 1, 2020, the owners of pharmacies that are located within this
state must report the intracompany delivery or distribution, into this state, of the drugs
described in subdivision 1, 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 pharmacies. Reporting shall be in the manner and format
specified by the board, and shall occur by the 15th day of each month, for deliveries and
distributions that occurred during the previous calendar month, except that the first report
submitted to the board shall include data retroactive to July 1, 2019.
new text end

new text begin Subd. 3. new text end

new text begin Invoicing and payment. new text end

new text begin (a) The board, beginning January 1, 2020, and at least
quarterly thereafter, shall use the data submitted under subdivision 2 to identify qualified
insulin products and prepare invoices for each manufacturer that is required to pay an insulin
product fee for a qualified insulin product, as required by this section. The invoices for each
quarter shall be prepared and sent to manufacturers no later than 30 days after the end of
each quarter, except that the first invoice prepared by the board shall be for the first three
quarters of fiscal year 2020. Manufacturers shall remit payment to the board by no later
than 30 days after the date of the invoice. If a manufacturer fails to remit payment by that
date, the board shall charge interest at the rate that manufacturers are charged interest for
making late Medicaid rebate payments.
new text end

new text begin (b) A manufacturer may dispute the amount invoiced by the board no later than 30 days
after the date of the invoice. However, the manufacturer must still remit payment for the
amount invoiced as required by this section. The dispute shall 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 original amount
invoiced was incorrect. The board shall make a decision concerning a dispute no later than
60 days after receiving the required forms. If the board determines that the manufacturer
has satisfactorily demonstrated that the original fee invoiced by the board was incorrect,
the board shall reimburse the manufacturer for any amount that is in excess of the correct
amount that should have been invoiced. The board shall make this reimbursement when it
notifies the manufacturer of its decision.
new text end

new text begin Subd. 4. new text end

new text begin Calculation of fees. new text end

new text begin The board shall calculate the fee that is to be paid by using
a base rate for all qualified insulin products, equal to $....... per unit, as defined by the board,
distributed or dispensed.
new text end

new text begin Subd. 5. new text end

new text begin Deposit of fees. new text end

new text begin The board shall deposit all fees collected under this section
into the insulin assistance account established under section 151.256.
new text end

Sec. 4.

new text begin [151.256] 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
151.2521 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 assistance account is appropriated to the commissioner of administration to
fund the insulin assistance program established under section 256.042.
new text end

Sec. 5.

Minnesota Statutes 2018, section 151.37, is amended by adding a subdivision to
read:

new text begin Subd. 2b. new text end

new text begin Emergency prescription refills. new text end

new text begin (a) A pharmacist may dispense a prescription
drug, other than a schedule II controlled substance, without a written or oral prescription
from a licensed health professional authorized to prescribe drugs, if all of the following
conditions are met:
new text end

new text begin (1) the pharmacy at which the pharmacist works has a record of the prescription for the
drug in the name of the patient who is requesting it, but the prescription does not provide
for a refill or the time permitted for providing refills has elapsed;
new text end

new text begin (2) the pharmacist is unable to obtain authorization to refill the prescription from the
health care professional who issued the prescription or another health professional responsible
for the patient's care; and
new text end

new text begin (3) in the exercise of the pharmacist's professional judgment:
new text end

new text begin (i) the drug is essential to sustain the life of the patient or continue therapy for a chronic
condition of the patient; and
new text end

new text begin (ii) failure to dispense or sell the drug to the patient could result in harm to the health
of the patient.
new text end

new text begin (b) The amount of the drug that may be dispensed or sold under this section shall not
exceed a 72-hour supply.
new text end

Sec. 6.

new text begin [256.042] INSULIN ASSISTANCE PROGRAM.
new text end

new text begin Subdivision 1. new text end

new text begin Establishment. new text end

new text begin The commissioner of human services shall implement
an insulin assistance program by January 1, 2020. Under the program, the commissioner
shall:
new text end

new text begin (1) reimburse pharmacies for insulin products and related supplies that are dispensed
by the pharmacy to qualified individuals subject to a valid prescription;
new text end

new text begin (2) accept statements of financial need from persons seeking to participate in the program
as qualified individuals, and maintain an up-to-date list of qualified individuals on the agency
website, that is available to participating pharmacies; and
new text end

new text begin (3) seek participation in the program by pharmacies in all areas of the state, and maintain
an up-to-date list of participating pharmacies on the agency website, that is available to
qualified individuals.
new text end

new text begin Subd. 2. new text end

new text begin Qualified individual. new text end

new text begin For purposes of this section, a "qualified individual" is
an individual who:
new text end

new text begin (1) does not have health coverage through medical assistance, MinnesotaCare, or a health
plan, as defined in section 62Q.01, subdivision 3; and
new text end

new text begin (2) submits to the commissioner a completed statement of financial need that has been
signed by the individual, and a physician or other health care professional who has issued
a prescription for insulin products to the individual.
new text end

new text begin Subd. 3. new text end

new text begin Statement of financial need. new text end

new text begin (a) The commissioner shall develop a statement
of financial need, and make this form available to health care professionals and individuals
on the agency website. The form must:
new text end

new text begin (1) state that the individual signing the form requires insulin products and related supplies
to avoid serious health complications;
new text end

new text begin (2) state that the individual signing the form has attested, to the physician or health
professional writing the prescription for insulin products and related supplies, that the
individual lacks the financial means to pay for these items, and does not have health coverage
through medical assistance, MinnesotaCare, or a health plan, as defined in section 62Q.01,
subdivision 3; and
new text end

new text begin (3) provide for the signature of both the individual and the physician or health care
professional.
new text end

new text begin (b) In order to participate in the program, an individual must submit the completed form
to the commissioner, and must submit a paper or electronic copy of the form to a participating
pharmacy when initially filling the prescription. An individual is eligible for the program
for 90 days, beginning on the date the form is completed and signed. An individual may
renew participation for additional 90-day periods, but must submit a new form to the
commissioner and participating pharmacy for each additional 90-day period of program
participation.
new text end

new text begin Subd. 4. new text end

new text begin Pharmacy participation. new text end

new text begin Pharmacy participation in the program is voluntary.
In order to participate, a pharmacy must register with the commissioner and agree to
reimbursement and other contract terms. A pharmacy shall dispense insulin products and
related supplies to qualified individuals who present a valid prescription and either are on
the list of qualified individuals maintained by the commissioner or, when initially filling a
prescription, present a completed statement of financial need that has not expired. Insulin
products and related supplies shall be dispensed at no cost to a qualified individual. When
dispensing insulin products and related supplies to a qualified individual, a pharmacy must
provide the qualified individual with information about any relevant drug manufacturer
patient discount programs, and contact information for local navigator or in-person assister
programs established under section 62V.05, subdivision 4.
new text end