Senator Wiklund moved to amend S.F. No. 12
Page 468, after line 26, insert:
"Sec. 7. Minnesota Statutes 2018, section 151.252, subdivision 1, as amended by Laws
2019, chapter 63, article 1, section 6, 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
(b) In addition to the license required under paragraph (a), each manufacturer required
to pay the registration fee under section
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,
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.
registration fee collected under this paragraph shall be deposited in the opiate epidemic
response account established under section
1.15(c) In addition to the license required under paragraph (a), a manufacturer of insulin
1.16must pay the applicable insulin registration fee in section 151.254, by June 1 of
1.17beginning June 1, 2020. In the event of a change of ownership of the manufacturer,
1.18owner must pay the registration fee in section 151.254 that the original owner would
1.19been assessed had it retained ownership. The board may assess a late fee of ten percent
1.20month for any portion of a month that the registration fee is paid after the due date.
1.21registration fee collected under this paragraph, including any late fees, shall be
1.22in the insulin assistance account established under section 256.938.
Application for a drug manufacturer license under this section shall be made in
a manner specified by the board.
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
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
for licensure of drug manufacturers that are not required to be registered under United
Code, title 21, section 360.
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
supplies the board with proof of licensure or registration. The board may establish,
standards for the licensure of a drug manufacturer that is not required to be licensed
registered by the state in which it is physically located.
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
which drugs that are shipped into the state are manufactured, except a manufacturer
opiate-containing controlled substances shall not be required to pay the fee under
2.10151.065, subdivision 1
, clause (16), or
151.065, subdivision 3
, clause (14), for more than
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
board may require the applicant to pay the cost of the inspection, in addition to
fee in section
, 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
States Food and Drug Administration, of an inspection that has occurred within the
months immediately preceding receipt of the license application by the board. The
may deny licensure unless the applicant submits documentation satisfactory to the
that any deficiencies noted in an inspection report have been corrected.
Sec. 8. [151.254] INSULIN REGISTRATION FEE.
2.23 Subdivision 1. Definition. (a) For purposes of this section, the following terms have the
2.24meanings given them.
2.25(b) "Manufacturer" means a manufacturer licensed under section 151.252 engaged in
2.26the manufacturing of insulin.
2.27(c) "Wholesaler" means a wholesale drug distributor licensed under section 151.47
2.28engaged in the wholesale drug distribution of insulin.
2.29 Subd. 2. Reporting requirements. (a) Effective March 1 of each year, beginning March
2.301, 2020, each manufacturer and each wholesaler must report to the Board of Pharmacy
2.31sale, delivery, or other distribution within or into the state of insulin that was
made to any
2.32practitioner, pharmacy, hospital, or other person who is permitted by section 151.37
2.33possess insulin for administration or was dispensed to human patients during the previous
3.1calendar year. Reporting must be in a manner specified by the board. If the manufacturer
3.2or wholesaler fails to provide information required under this paragraph on a timely
3.3the board may assess an administrative penalty of $100 per day. This penalty shall
3.4considered a form of disciplinary action. Any penalty assessed under this section
3.5deposited in the insulin assistance account established under section 256.938.
3.6(b) By March 1 of each year, beginning March 1, 2020, each owner of a pharmacy with
3.7at least one location within this state must report to the board any intracompany
3.8or distribution of insulin into this state, to the extent that those deliveries and
3.9are not reported to the board by a licensed wholesaler owned by, under contract to,
3.10otherwise operating on behalf of the owner of the pharmacy. Reporting must be in the
3.11manner and format specified by the board for deliveries and distributions that occurred
3.12during the previous calendar year. The report must include the name of the manufacturer
3.13or wholesaler from which the owner of the pharmacy ultimately purchased the insulin
3.14the amount and date the purchase occurred.
3.15 Subd. 3. Determination of manufacturer's registration fee. (a) The board shall annually
3.16assess manufacturers a registration fee that in aggregate equals the total cost of
3.17assistance program established under section 256.937 for the previous fiscal year,
3.18exceed $5,000,000, including any administration costs incurred by the commissioner
3.19human services or the board in collecting the fee. The board shall determine each
3.20manufacturer's annual insulin registration fee that is prorated and based on the manufacturer's
3.21percentage of the total number of units reported to the board under subdivision 2.
3.22first assessment, the commissioner shall estimate the cost of the program for the
3.23year and notify the board of the estimated cost by March 1, 2020. The board shall
3.24each manufacturer's initial registration fee based on the estimated cost.
3.25(b) By April 1 of each year, beginning April 1, 2020, the board shall notify each
3.26manufacturer of the annual amount of the manufacturer's insulin registration fee to
3.27in accordance with section 151.252, subdivision 1, paragraph (c).
3.28(c) A manufacturer may dispute the fee assessed under this section as determined by
3.29board no later than 30 days after the date of notification. However, the manufacturer
3.30still remit the registration fee required by section 151.252, subdivision 1, paragraph
3.31dispute must be filed with the board in the manner and using the forms specified by
3.32board. A manufacturer must submit, with the required forms, data satisfactory to the
3.33that demonstrates that the fee was incorrect or otherwise unwarranted. The board must
3.34a decision concerning a dispute no later than 60 days after receiving the required
3.35forms. If the board determines that the manufacturer has satisfactorily demonstrated
4.1the original fee was incorrect, the board must: (1) adjust the manufacturer's fee;
4.2the manufacturer's fee due the next year by the amount in excess of the correct fee
4.3should have been paid; or (3) refund the amount paid in error.
4.4 Subd. 4. Exclusion. This section does not include biosimilars produced or distributed
4.5pursuant to a biologics license application, approved under United States Code, title
4.6section 262(k)(3), nor insulin products, for which the wholesale acquisition cost
is less than
4.7$80 per package. For the purposes of this subdivision, "biosimilars" does not include
4.8reference product licensed under United States Code, title 42, section 262(a) or follow-on
4.9insulin products initially licensed under United States Code, title 21, section 355(b)(2),
4.10to March 23, 2020.
Page 477, after line 27, insert:
"Sec. 11. [256.937] INSULIN ASSISTANCE PROGRAM.
4.13 Subdivision 1. Establishment. (a) The commissioner of human services shall implement
4.14an insulin assistance program by July 1, 2020. Under the program, the commissioner
4.15(1) pay participating pharmacies for insulin that is dispensed by a participating
4.16to an eligible individual subject to a valid prescription; and
4.17(2) ensure pharmacy participation in the program in all areas of the state and maintain
4.18an up-to-date list of participating pharmacies on the department's website.
4.19(b) The commissioner may contract with a private entity or enter into an interagency
4.20agreement with another state agency to implement this program.
4.21 Subd. 2. Eligible individual. (a) To be eligible for the insulin assistance program, an
4.22individual must submit to the commissioner an application form that is signed by the
4.23individual. To be eligible, an individual must:
4.24(1) be a resident of Minnesota;
4.25(2) not be eligible for Medicare, medical assistance, or MinnesotaCare;
4.26(3) have a family income that is equal to or less than 400 percent of the federal
4.28(4) be uninsured, have no prescription drug coverage, or be covered by an individual
4.29group health plan with an out-of-pocket limit of $5,000 or greater.
4.30Eligibility for the insulin assistance program is subject to the limits of available
5.1(b) The commissioner shall develop an application form and make the form available
5.2to pharmacies, health care providers, and to individuals on the department's website.
5.3applicant must include their income and insurance status information with the application.
5.4The commissioner may require the applicant to submit additional information to verify
5.5eligibility if deemed necessary by the commissioner.
5.6(c) Upon receipt of a completed application and any additional information requested
5.7by the commissioner, the commissioner shall determine eligibility to the program.
5.8the individual has been determined eligible, the individual shall be issued an identification
5.9card. The card shall be valid for 90 days from the date of issuance and may be used
5.10participating pharmacy. An individual is not eligible for renewal until 12 months
5.11card's expiration date, at which time the individual must submit a new application
5.12meet the qualifications in paragraph (a).
5.13 Subd. 3. Pharmacy participation. (a) Pharmacy participation in the program is voluntary.
5.14In order to participate, a pharmacy must register with the commissioner and agree
5.15reimbursement and other contract terms. A pharmacy may withdraw from participation
5.16any time by providing written notice to the commissioner.
5.17(b) A pharmacy shall dispense insulin to eligible individuals who present a valid
5.18prescription and an identification card.
5.19(c) Eligible individuals are responsible for paying an insulin co-payment to the
5.20participating pharmacy that is equal to the prescription co-payment required under
5.21256L.03, subdivision 5.
5.22(d) Not withstanding paragraph (c), if an eligible individual has coverage through
5.23individual or group health plan, the pharmacy must process the insulin in accordance
5.24the individual's health plan.
5.25(e) When dispensing insulin to an eligible individual, a pharmacy must provide the
5.26individual with the address for the website established under section 151.06, subdivision
5.276, paragraph (a).
Sec. 12. [256.938] INSULIN ASSISTANCE ACCOUNT.
5.29 Subdivision 1. Establishment. The insulin assistance account is established in the special
5.30revenue fund in the state treasury. The fees collected by the Board of Pharmacy under
5.31151.252, subdivision 1, paragraph (c), shall be deposited into the account.
6.1 Subd. 2. Use of account funds. For fiscal year 2021 and subsequent fiscal years, money
6.2in the insulin assistance account is appropriated to the commissioner of human services
6.3fund the insulin assistance program established under section 256.937.
Sec. 13. CITATION.
6.5The amendments to Minnesota Statutes, section 256.937, may be cited as "The Alec
6.6Smith Emergency Insulin Act."
Renumber the sections in sequence and correct the internal references
Put sections in statutory order
The motion prevailed. #did not prevail. So the amendment was #not adopted.