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.................... moves to amend H.F. No. 485, the first engrossment, as follows:​

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Delete everything after the enacting clause and insert:​

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"Section 1. CITATION.​
This act may be cited as "The Alec Smith Emergency Insulin Act."​
Sec. 2. [151.245] INSULIN REPORTING AND REGISTRATION FEE.​
Subdivision 1. Definitions. (a) For purposes of this section, the following terms have​
the meanings given them.​
(b) "Manufacturer" means a manufacturer licensed under section 151.252 engaged in​
the manufacturing of insulin.​
(c) "Wholesaler" means a wholesale drug distributor licensed under section 151.47 and​
engaged in the wholesale drug distribution of insulin.​

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Subd. 2. Reporting requirements. (a) Effective March 1 of each year, beginning March​

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1, 2020, each manufacturer and each wholesaler must report to the Board of Pharmacy every​

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sale, delivery, or other distribution within or into the state of insulin that was made to any​

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practitioner, pharmacy, hospital, or other person who is permitted by section 151.37 to​

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possess insulin for administration or was dispensed to human patients during the previous​

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calendar year. Reporting must be in the manner and format specified by the board.​

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(b) By March 1 of each year, beginning March 1, 2020, each owner of a pharmacy with​

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at least one location within this state must report to the board any intracompany delivery​

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or distribution of insulin into this state, to the extent that those deliveries and distributions​

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are not reported to the board by a licensed wholesaler owned by, under contract to, or​

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otherwise operating on behalf of the owner of the pharmacy. Reporting must be in the​

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manner and format specified by the board for deliveries and distributions that occurred​

Sec. 2.​

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during the previous calendar year. The report must include the name of the manufacturer​

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or wholesaler from which the owner of the pharmacy ultimately purchased the insulin and​

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the amount and date the purchase occurred.​

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(c) If the manufacturer, wholesaler, or pharmacy fails to provide information required​

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under this section on a timely basis, the board may assess an administrative penalty of $100​

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per day. This penalty shall not be considered a form of disciplinary action. Any penalty​

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assessed under this section shall be deposited in the insulin assistance account established​

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under section 256.938.​

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Subd. 3. Determination of manufacturer's registration fee. (a) The board shall annually​

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assess manufacturers a registration fee that in aggregate equals the total cost of the insulin​

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assistance program established under section 256.937 for the previous fiscal year, including​

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any state appropriation to the commissioner of human services for the program and any​

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administrative costs incurred by the commissioner of human services or the board in​

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collecting the fee, plus any outstanding liabilities to the program. The board shall determine​

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for each manufacturer a prorated annual insulin registration fee that is based on the​

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manufacturer's percentage of the total number of units reported to the board under subdivision​

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2. For the first assessment, the commissioner shall estimate the cost of the program for the​

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first fiscal year and notify the board of the estimated cost by March 1, 2020. The board shall​

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determine each manufacturer's initial registration fee based on the estimated cost.​

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(b) By April 1 of each year, beginning April 1, 2020, the board shall notify each​

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manufacturer of the annual amount of the manufacturer's insulin registration fee to be paid​

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in accordance with section 151.252, subdivision 1, paragraph (c).​

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(c) A manufacturer may dispute the fee assessed under this section as determined by the​

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board no later than 30 days after the date of notification. However, the manufacturer must​

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still remit the registration fee required by section 151.252, subdivision 1, paragraph (c). The​

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dispute must be filed with the board in the manner and using the forms specified by the​

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board. A manufacturer must submit, with the required forms, data satisfactory to the board​

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that demonstrates that the fee was incorrect or otherwise unwarranted. The board must make​

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a decision concerning a dispute no later than 60 days after receiving the required dispute​

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forms. If the board determines that the manufacturer has satisfactorily demonstrated that​

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the original fee was incorrect, the board must:​

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(1)(i) adjust the manufacturer's fee;​

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(ii) adjust the manufacturer's fee due the next year by the amount in excess of the correct​

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fee that should have been paid; or​

Sec. 2.​

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(iii) refund the amount paid in error; and​

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(2) adjust the fees of other manufacturers as needed to ensure that the registration fee​

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in the aggregate meets the requirements of paragraph (a).​

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(d) If a manufacturer fails to provide information required under subdivision 2 on a​

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timely basis, the board may set an annual insulin registration fee for that manufacturer,​

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taking into account that manufacturer's percentage of the total number of units of insulin​

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sold, delivered, or distributed under the medical assistance program during the previous​

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calendar year.​

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Sec. 3. Minnesota Statutes 2019 Supplement, section 151.252, subdivision 1, is amended​
to read:​

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Subdivision 1. Requirements. (a) No person shall act as a drug manufacturer without​

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first obtaining a license from the board and paying any applicable fee specified in section​

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151.065.​

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(b) In addition to the license required under paragraph (a), each manufacturer required​

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to pay the registration fee under section 151.066 must pay the fee by June 1 of each year,​

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beginning June 1, 2020. In the event of a change of ownership of the manufacturer, the new​

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owner must pay the registration fee specified under section 151.066, subdivision 3, that the​

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original owner would have been assessed had the original owner retained ownership. The​

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registration fee collected under this paragraph shall be deposited in the opiate epidemic​

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response account established under section 256.043.​

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(c) In addition to the license required under paragraph (a), a manufacturer of insulin​

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must pay the applicable insulin registration fee in section 151.245, by June 1 of each year,​

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beginning June 1, 2020. In the event of a change of ownership of the manufacturer, the new​

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owner must pay the registration fee in section 151.245 that the original owner would have​

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been assessed had it retained ownership. The board may assess a late fee of ten percent per​

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month for any portion of a month that the registration fee is paid after the due date. The​

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registration fee collected under this paragraph, including any late fees, shall be deposited​

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in the insulin assistance account established under section 256.938.​

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(c) (d) Application for a drug manufacturer license under this section shall be made in​
a manner specified by the board.​

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(d) (e) No license shall be issued or renewed for a drug manufacturer unless the applicant​

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agrees to operate in a manner prescribed by federal and state law and according to Minnesota​

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Rules.​

Sec. 3.​

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(e) (f) No license shall be issued or renewed for a drug manufacturer that is required to​

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be registered pursuant to United States Code, title 21, section 360, unless the applicant​

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supplies the board with proof of registration. The board may establish by rule the standards​

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for licensure of drug manufacturers that are not required to be registered under United States​

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Code, title 21, section 360.​

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(f) (g) No license shall be issued or renewed for a drug manufacturer that is required to​

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be licensed or registered by the state in which it is physically located unless the applicant​

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supplies the board with proof of licensure or registration. The board may establish, by rule,​

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standards for the licensure of a drug manufacturer that is not required to be licensed or​

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registered by the state in which it is physically located.​

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(g) (h) The board shall require a separate license for each facility located within the state​

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at which drug manufacturing occurs and for each facility located outside of the state at​

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which drugs that are shipped into the state are manufactured, except a manufacturer of​

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opiate-containing controlled substances shall not be required to pay the fee under section​

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151.065, subdivision 1, clause (16), or subdivision 3, clause (14), for more than one facility.​

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(h) (i) Prior to the issuance of an initial or renewed license for a drug manufacturing​

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facility, the board may require the facility to pass a current good manufacturing practices​

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inspection conducted by an authorized representative of the board. In the case of a drug​

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manufacturing facility located outside of the state, the board may require the applicant to​

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pay the cost of the inspection, in addition to the license fee in section 151.065, unless the​

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applicant furnishes the board with a report, issued by the appropriate regulatory agency of​

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the state in which the facility is located or by the United States Food and Drug​

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Administration, of an inspection that has occurred within the 24 months immediately​

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preceding receipt of the license application by the board. The board may deny licensure​

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unless the applicant submits documentation satisfactory to the board that any deficiencies​

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noted in an inspection report have been corrected.​

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Sec. 4. [256.937] EMERGENCY INSULIN ASSISTANCE PROGRAM.​
Subdivision 1. Establishment. (a) The commissioner of human services shall implement​

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an emergency insulin assistance program by July 1, 2020. Under the program, the​

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commissioner shall process claims and pay participating pharmacies for insulin that is​

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dispensed by the participating pharmacy to an eligible individual.​

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(b) The commissioner may contract with a private entity or enter into an interagency​
agreement with another state agency to implement the program or specific requirements of​

Sec. 4.​

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the program. If the commissioner contracts with a private entity, the contract must prohibit​

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the use of rebates.​

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(c) For purposes of this section, "program" means the emergency insulin assistance​
program established under this section.​
Subd. 2. Eligibility requirements. (a) To be eligible for the program, an individual​
must:​

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(1) be a resident of Minnesota;​

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(2) have a family income that is equal to or less than 600 percent of the federal poverty​

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guidelines;​
(3) be uninsured, have no prescription drug coverage, or have prescription drug coverage​

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through an individual or group health plan with an annual out-of-pocket maximum limit​

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for prescription drugs of $3,000 or greater, or an annual out-of-pocket maximum limit of​

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$5,000 or greater if the health plan does not have a specific out-of-pocket maximum for​

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prescription drugs; and​

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(4) not have participated in the program within the 12 months preceding the application​
date.​

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(b) Eligibility for the program is subject to the limits of available funding.​

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Subd. 3. Application. The commissioner shall develop an application form and make​

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the form available on the department's website to pharmacies, health care providers, and​

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individuals. An applicant must include their income and insurance status information with​

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the application. The application must require the applicant to sign the application attesting​

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that the information contained in the application is correct. The commissioner may require​

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the applicant to submit additional information to verify eligibility if deemed necessary by​

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the commissioner.​

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Subd. 4. Pharmacy participation. (a) An individual may present to a participating​

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pharmacy a completed application form that has been signed by the individual attesting that​

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the information contained in the application is correct.​

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(b) Upon receipt of a completed and signed application form that indicates that the​

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individual is presumptively eligible for the program, and a valid prescription, the participating​

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pharmacy shall dispense the prescribed insulin in an amount that is equivalent to a 30-day​

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supply of insulin. The participating pharmacy shall submit the individual's completed​

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application form to the commissioner within two business days of receipt, and the​

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commissioner shall determine eligibility in accordance with subdivision 5. An individual​
Sec. 4.​

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who has been deemed eligible for the program by the commissioner in accordance with​

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subdivision 5, and who presents a valid prescription, may receive up to two additional​

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30-day supplies of insulin from participating pharmacies during the 90-day period of program​

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eligibility.​

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(c) Notwithstanding paragraph (b), if an individual presents to a participating pharmacy​

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a completed and signed application indicating that the individual is presumptively eligible​

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but the individual does not have a valid prescription for insulin, the pharmacy shall dispense​

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the insulin in accordance with this subdivision if the conditions described in section 151.211,​

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subdivision 3, paragraph (a), are met.​

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(d) If an individual presents at any pharmacy licensed under chapter 151, the pharmacy​

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must provide the individual with an application form for the emergency insulin assistance​

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program. If the pharmacy is a participating pharmacy, the pharmacy shall dispense insulin​

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to the individual as required under paragraph (b).​

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(e) If an individual has prescription drug coverage through an individual or group health​

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plan, the pharmacy must submit the claim to the individual's health carrier as primary​

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coverage before submitting the claim for reimbursement through the program, as secondary​

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coverage. An eligible individual is responsible for paying an insulin co-payment to the​

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participating pharmacy that is equal to the prescription co-payment required under section​

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256L.03, subdivision 5.​

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(f) When dispensing insulin to an eligible individual, a pharmacy must provide the​

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individual with the address for the website established under section 151.06, subdivision​

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6, paragraph (a).​

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Subd. 5. Commissioner's duties. (a) Upon receipt of a completed application from a​

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participating pharmacy under subdivision 4, and any additional information from the​

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individual if requested by the commissioner, the commissioner shall determine if the​

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individual is eligible for the program within 30 days of receiving the application and any​

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additional information. If the individual is determined to be eligible, the commissioner shall​

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enroll the individual in the program. Program eligibility shall extend for a period of 90 days​

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from the date the participating pharmacy received the completed and signed application​

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form from the individual under subdivision 4.​

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(b) If the individual is determined to be eligible for either medical assistance or​

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MinnesotaCare, the individual shall not be eligible for the emergency insulin assistance​

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program after the initial presumptive eligibility period.​

Sec. 4.​

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(c) The commissioner shall connect each eligible individual with the social service​

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agency in the county in which the individual resides to assist the individual in exploring​

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long-term insulin coverage options.​

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Subd. 6. Report. By January 15, 2022, and by each January 15 thereafter, the​

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commissioner shall submit a report to the chairs and ranking minority members of the​

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legislative committees with jurisdiction over health and human services policy and finance​

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on the emergency insulin assistance program for the previous fiscal year, including:​

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(1) the number of individuals who participated in the program;​

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(2) the cost of the program, specifying the administrative costs;​

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(3) the number of individuals who were presumptively eligible but determined to be​

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ineligible for the program;​
(4) the number of individuals who were presumptively eligible and were determined​
eligible for public health care programs; and​
(5) the number of individuals who reapplied for the program.​
Sec. 5. [256.938] INSULIN ASSISTANCE ACCOUNT.​

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Subdivision 1. Establishment. The insulin assistance account is established in the special​

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revenue fund in the state treasury. The fees collected by the Board of Pharmacy under section​

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151.252, subdivision 1, paragraph (c), shall be deposited into the account.​

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Subd. 2. Use of account funds. For fiscal year 2020 and subsequent fiscal years, money​

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in the insulin assistance account is appropriated to the commissioner of human services to:​

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(1) fund the emergency insulin assistance program established under section 256.937; and​

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(2) repay the general fund for any appropriation provided to the commissioner to implement​

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the emergency insulin assistance program.​

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Sec. 6. EARLIER IMPLEMENTATION DATE FOR THE EMERGENCY INSULIN​
ASSISTANCE PROGRAM.​
(a) The governor may direct by executive order the commissioner of human services to​

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begin operating the emergency insulin assistance program before the July 1, 2020,​

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implementation date.​

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(b) If the governor does not issue an executive order under paragraph (a), the​

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commissioner of human services shall implement the program by July 1, 2020, as required​

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under Minnesota Statutes, section 256.937.​

Sec. 6.​

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Sec. 7. APPROPRIATION.​

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$....... is appropriated in fiscal year 2020 from the general fund to the commissioner of​

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human services to implement the emergency insulin assistance program as required under​

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Minnesota Statutes, section 256.937. In fiscal year 2021, the commissioner of management​

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and budget shall reduce the balance of the insulin assistance account by $....... and repay​

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the general fund for the cost of this appropriation to the commissioner of human services.​

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Sec. 8. EFFECTIVE DATE.​

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Sections 1 through 7 are effective the day following final enactment."​

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Amend the title accordingly​

Sec. 8.​

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