Senate Floor Amendment

1ss0012a-1 1ss0012a-1

1.1Senator Wiklund moved to amend S.F. No. 12 as follows:
1.2Page 468, after line 26, insert:

1.3    "Sec. 7. Minnesota Statutes 2018, section 151.252, subdivision 1, as amended by Laws
1.42019, chapter 63, article 1, section 6, is amended to read:
1.5    Subdivision 1. Requirements. (a) No person shall act as a drug manufacturer without
1.6first obtaining a license from the board and paying any applicable fee specified in section
1.7151.065 .
1.8(b) In addition to the license required under paragraph (a), each manufacturer required
1.9to pay the registration fee under section 151.066 must pay the fee by June 1 of each year,
1.10beginning June 1, 2020. In the event of a change of ownership of the manufacturer, the new
1.11owner must pay the registration fee specified under section 151.066, subdivision 3, that the
1.12original owner would have been assessed had the original owner retained ownership. The
1.13registration fee collected under this paragraph shall be deposited in the opiate epidemic
1.14response account established under section 256.043.
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 each year,
1.17beginning June 1, 2020. In the event of a change of ownership of the manufacturer, the new
1.18owner must pay the registration fee in section 151.254 that the original owner would have
1.19been assessed had it retained ownership. The board may assess a late fee of ten percent per
1.20month for any portion of a month that the registration fee is paid after the due date. The
1.21registration fee collected under this paragraph, including any late fees, shall be deposited
1.22in the insulin assistance account established under section 256.938.
1.23    (c) (d) Application for a drug manufacturer license under this section shall be made in
1.24a manner specified by the board.
1.25    (d) (e) No license shall be issued or renewed for a drug manufacturer unless the applicant
1.26agrees to operate in a manner prescribed by federal and state law and according to Minnesota
1.28    (e) (f) No license shall be issued or renewed for a drug manufacturer that is required to
1.29be registered pursuant to United States Code, title 21, section 360, unless the applicant
1.30supplies the board with proof of registration. The board may establish by rule the standards
1.31for licensure of drug manufacturers that are not required to be registered under United States
1.32Code, title 21, section 360.
2.1    (f) (g) No license shall be issued or renewed for a drug manufacturer that is required to
2.2be licensed or registered by the state in which it is physically located unless the applicant
2.3supplies the board with proof of licensure or registration. The board may establish, by rule,
2.4standards for the licensure of a drug manufacturer that is not required to be licensed or
2.5registered by the state in which it is physically located.
2.6    (g) (h) The board shall require a separate license for each facility located within the state
2.7at which drug manufacturing occurs and for each facility located outside of the state at
2.8which drugs that are shipped into the state are manufactured, except a manufacturer of
2.9opiate-containing controlled substances shall not be required to pay the fee under section
2.10151.065, subdivision 1 , clause (16), or 151.065, subdivision 3, clause (14), for more than
2.11one facility.
2.12    (h) (i) The board shall not issue an initial or renewed license for a drug manufacturing
2.13facility unless the facility passes an inspection conducted by an authorized representative
2.14of the board. In the case of a drug manufacturing facility located outside of the state, the
2.15board may require the applicant to pay the cost of the inspection, in addition to the license
2.16fee in section 151.065, unless the applicant furnishes the board with a report, issued by the
2.17appropriate regulatory agency of the state in which the facility is located or by the United
2.18States Food and Drug Administration, of an inspection that has occurred within the 24
2.19months immediately preceding receipt of the license application by the board. The board
2.20may deny licensure unless the applicant submits documentation satisfactory to the board
2.21that any deficiencies noted in an inspection report have been corrected.

2.22    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 and
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 every
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 to
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 basis,
3.3the board may assess an administrative penalty of $100 per day. This penalty shall not be
3.4considered a form of disciplinary action. Any penalty assessed under this section shall be
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 delivery
3.8or distribution of insulin into this state, to the extent that those deliveries and distributions
3.9are not reported to the board by a licensed wholesaler owned by, under contract to, or
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 and
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 the insulin
3.17assistance program established under section 256.937 for the previous fiscal year, not to
3.18exceed $5,000,000, including any administration costs incurred by the commissioner of
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. For the
3.22first assessment, the commissioner shall estimate the cost of the program for the first fiscal
3.23year and notify the board of the estimated cost by March 1, 2020. The board shall determine
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 be paid
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 the
3.29board no later than 30 days after the date of notification. However, the manufacturer must
3.30still remit the registration fee required by section 151.252, subdivision 1, paragraph (c). The
3.31dispute must be filed with the board in the manner and using the forms specified by the
3.32board. A manufacturer must submit, with the required forms, data satisfactory to the board
3.33that demonstrates that the fee was incorrect or otherwise unwarranted. The board must make
3.34a decision concerning a dispute no later than 60 days after receiving the required dispute
3.35forms. If the board determines that the manufacturer has satisfactorily demonstrated that
4.1the original fee was incorrect, the board must: (1) adjust the manufacturer's fee; (2) adjust
4.2the manufacturer's fee due the next year by the amount in excess of the correct fee that
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 42,
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 a
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), prior
4.10to March 23, 2020."
4.11Page 477, after line 27, insert:

4.12    "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 shall:
4.15(1) pay participating pharmacies for insulin that is dispensed by a participating pharmacy
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 poverty
4.27guidelines; and
4.28(4) be uninsured, have no prescription drug coverage, or be covered by an individual or
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 funding.
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. An
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. Once
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 at any
5.10participating pharmacy. An individual is not eligible for renewal until 12 months from the
5.11card's expiration date, at which time the individual must submit a new application form and
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 to
5.15reimbursement and other contract terms. A pharmacy may withdraw from participation at
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 section
5.21256L.03, subdivision 5.
5.22(d) Not withstanding paragraph (c), if an eligible individual has coverage through an
5.23individual or group health plan, the pharmacy must process the insulin in accordance with
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).

5.28    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 section
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 to
6.3fund the insulin assistance program established under section 256.937.

6.4    Sec. 13. CITATION.
6.5The amendments to Minnesota Statutes, section 256.937, may be cited as "The Alec
6.6Smith Emergency Insulin Act.""
6.7Renumber the sections in sequence and correct the internal references
6.8Put sections in statutory order
6.9The motion prevailed. #did not prevail. So the amendment was #not adopted.