HF 485

1st Engrossment - 91st Legislature (2019 - 2020) Posted on 03/09/2020 05:54pm

A bill for an act
relating to human services; establishing the pharmaceutical assistance program;
establishing the insulin assistance account in the special revenue fund; establishing
fees and penalties; appropriating money; amending Minnesota Statutes 2018,
sections 147.37; 151.06, by adding a subdivision; 151.252, subdivision 1; proposing
coding for new law in Minnesota Statutes, chapters 148; 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 147.37, is amended to read:

147.37 INFORMATION PROVISION; PHARMACEUTICAL ASSISTANCE
PROGRAMS.

new text begin At least annually, new text end the board shall encourage licensees new text begin who are authorized to prescribe
drugs new text end to make available to patients information on deleted text begin free and discounted prescription drug
programs offered by pharmaceutical manufacturers when the information is provided to the
licensees at no cost deleted text end new text begin sources of lower cost prescription drugs and shall provide these licensees
with the address for the website established by the Board of Pharmacy pursuant to section
151.06, subdivision 6 new text end .

Sec. 3.

new text begin [148.192] INFORMATION PROVISION; PHARMACEUTICAL
ASSISTANCE PROGRAMS.
new text end

new text begin At least annually, the board shall encourage licensees who are authorized to prescribe
drugs to make available to patients information on sources of lower cost prescription drugs
and shall provide these licensees with the address for the website established by the Board
of Pharmacy pursuant to section 151.06, subdivision 6.
new text end

Sec. 4.

Minnesota Statutes 2018, section 151.06, is amended by adding a subdivision to
read:

new text begin Subd. 6. new text end

new text begin Information provision; sources of lower cost prescription drugs. new text end

new text begin (a) The
board shall publish a page on its website that provides regularly updated information
concerning:
new text end

new text begin (1) pharmaceutical manufacturer patient assistance programs;
new text end

new text begin (2) the prescription drug assistance program established by the Minnesota Board of
Aging under section 256.975, subdivision 9;
new text end

new text begin (3) the emergency insulin assistance program established under section 256.937;
new text end

new text begin (4) the 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;
new text end

new text begin (5) the program established under section 340b of the federal Public Health Services
Act, United States Code, title 42, section 256b; and
new text end

new text begin (6) any other resource that the board deems useful to individuals who are attempting to
purchase prescription drugs at lower costs.
new text end

new text begin (b) The board shall prepare educational documents and materials, including brochures
and posters, based on the information it provides on its website under paragraph (a). The
documents and materials shall be in a form that can be downloaded from the board's website
and used for patient education by pharmacists and by practitioners who are licensed to
prescribe. The board is not required to provide printed copies of these documents and
materials.
new text end

new text begin (c) At least annually, the board shall encourage licensed pharmacists and pharmacies to
make available to patients information on sources of lower cost prescription drugs and shall
provide these licensees with the address for the website established under paragraph (a).
new text end

Sec. 5.

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.

new text begin (b) In addition to the license required under paragraph (a), a manufacturer of insulin
must pay the applicable insulin registration fee in section 151.254, 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 in section 151.254 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 256.938.
new text end

deleted text begin (b) deleted text end new text begin (c) 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 (c) deleted text end new text begin (d) 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 (d) deleted text end new text begin (e) 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 (e) deleted text end new text begin (f) 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 (f) deleted text end new text begin (g) 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.

deleted text begin (g) deleted text end new text begin (h) new text end 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.

Sec. 6.

new text begin [151.254] INSULIN REGISTRATION FEE.
new text end

new text begin Subdivision 1. new text end

new text begin Definition. 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) Effective 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 within or into the state of insulin that was made to any
practitioner, pharmacy, hospital, or other person who is permitted by section 151.37 to
possess insulin for administration or was dispensed to human patients during the previous
calendar year. Reporting must be in a manner specified by the board. If the 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. Any penalty assessed under this section shall be
deposited in the insulin assistance account established under section 256.938.
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 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 the insulin
assistance program established under section 256.937 for the previous fiscal year, including
any administration costs incurred by the commissioner of human services or the board in
collecting the fee. The board shall determine each manufacturer's annual insulin registration
fee that is prorated and 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 March 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 April 1 of each year, beginning April 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 (b).
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 (b).
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: (1) adjust the manufacturer's fee; (2)
adjust the manufacturer's fee due the next year by the amount in excess of the correct fee
that should have been paid; or (3) refund the amount paid in error.
new text end

Sec. 7.

new text begin [256.937] 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 human services shall implement
an insulin assistance program by July 1, 2020. Under the program, the commissioner shall:
new text end

new text begin (1) pay participating pharmacies for insulin that is dispensed by a participating pharmacy
to an eligible individual subject to a valid prescription;
new text end

new text begin (2) maintain an up-to-date list of eligible individuals and make the list available to
participating pharmacies; and
new text end

new text begin (3) ensure pharmacy participation in the program in all areas of the state and maintain
an up-to-date list of participating pharmacies on the department's website.
new text end

new text begin (b) The commissioner may contract with a private entity or enter into an interagency
agreement with another state agency to implement this program.
new text end

new text begin Subd. 2. new text end

new text begin Eligible individual. new text end

new text begin (a) To be eligible for the insulin assistance program, an
individual must submit to the commissioner an application form that is signed by the
individual. To be eligible, an individual must:
new text end

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

new text begin (2) not be eligible for Medicare, medical assistance, or MinnesotaCare;
new text end

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

new text begin (4) be uninsured, have no prescription drug coverage, or be covered by an individual or
group health plan with an out-of-pocket limit of $5,000 or greater.
new text end

new text begin (b) The commissioner shall develop an application form and make the form available
to pharmacies, health care providers, and to individuals on the department's website. An
applicant must include their income and insurance status information with the application.
The commissioner may require the applicant to submit additional information to verify
eligibility if deemed necessary by the commissioner.
new text end

new text begin (c) Upon receipt of a completed application and any additional information requested
by the commissioner, the commissioner shall determine eligibility to the program. Once
the individual has been determined eligible, the individual shall be issued an identification
card. The card shall be valid for 90 days from the date of issuance and may be used at any
participating pharmacy. An individual is not eligible for renewal until 12 months from the
card's expiration date, at which time the individual must submit a new application form and
meet the qualifications in paragraph (a).
new text end

new text begin Subd. 3. new text end

new text begin Pharmacy participation. new text end

new text begin (a) 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 may withdraw from participation at
any time by providing written notice to the commissioner.
new text end

new text begin (b) A pharmacy shall dispense insulin to eligible individuals who present a valid
prescription and an identification card.
new text end

new text begin (c) Eligible individuals are responsible for paying an insulin co-payment to the
participating pharmacy that is equal to the prescription co-payment required under section
256L.03, subdivision 5.
new text end

new text begin (d) Notwithstanding paragraph (c), if an eligible individual has coverage through an
individual or group health plan, the pharmacy must process the insulin in accordance with
the individual's health plan.
new text end

new text begin (e) When dispensing insulin to an eligible individual, a pharmacy must provide the
individual with the address for the website established under section 151.06, subdivision
6, paragraph (a).
new text end

Sec. 8.

new text begin [256.938] 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 (b), 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 2021 and subsequent fiscal years, money
in the insulin assistance account is appropriated to the commissioner of human services to
fund the insulin assistance program established under section 256.937.
new text end