| 37 | | - | Adoption of Report: Amended and re-referred to the Committee on State and Local Government Finance and Policy02/06/2023 |
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| 38 | | - | Adoption of Report: Amended and re-referred to the Committee on Health Finance and Policy02/08/2023 2.1 Subd. 4.Manufacturer."Manufacturer" means an entity that: |
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| 39 | | - | 2.2 (1) engages in the manufacture of a prescription drug product or enters into a lease with |
|---|
| 40 | | - | 2.3another manufacturer to market and distribute a prescription drug product under the entity's |
|---|
| 41 | | - | 2.4own name; and |
|---|
| 42 | | - | 2.5 (2) sets or changes the wholesale acquisition cost of the prescription drug product it |
|---|
| 43 | | - | 2.6manufactures or markets. |
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| 44 | | - | 2.7 Subd. 5.Prescription drug."Prescription drug" means a drug for human use subject |
|---|
| 45 | | - | 2.8to United States Code, title 21, section 353(b)(1). |
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| 46 | | - | 2.9 Subd. 6.Wholesale acquisition cost."Wholesale acquisition cost" has the meaning |
|---|
| 47 | | - | 2.10provided in United States Code, title 42, section 1395w-3a. |
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| 48 | | - | 2.11 Subd. 7.Wholesale distributor."Wholesale distributor" has the meaning provided in |
|---|
| 49 | | - | 2.12section 151.441, subdivision 14. |
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| 50 | | - | 2.13 Sec. 2. [62J.842] EXCESSIVE PRICE INCREASES PROHIBITED. |
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| 51 | | - | 2.14 Subdivision 1.Prohibition.No manufacturer shall impose, or cause to be imposed, an |
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| 52 | | - | 2.15excessive price increase, whether directly or through a wholesale distributor, pharmacy, or |
|---|
| 53 | | - | 2.16similar intermediary, on the sale of any generic or off-patent drug sold, dispensed, or |
|---|
| 54 | | - | 2.17delivered to any consumer in the state. |
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| 55 | | - | 2.18 Subd. 2.Excessive price increase.A price increase is excessive for purposes of this |
|---|
| 56 | | - | 2.19section when: |
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| 57 | | - | 2.20 (1) the price increase, adjusted for inflation utilizing the Consumer Price Index, exceeds: |
|---|
| 58 | | - | 2.21 (i) 15 percent of the wholesale acquisition cost over the immediately preceding calendar |
|---|
| 59 | | - | 2.22year; or |
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| 60 | | - | 2.23 (ii) 40 percent of the wholesale acquisition cost over the immediately preceding three |
|---|
| 61 | | - | 2.24calendar years; and |
|---|
| 62 | | - | 2.25 (2) the price increase, adjusted for inflation utilizing the Consumer Price Index, exceeds |
|---|
| 63 | | - | 2.26$30 for: |
|---|
| 64 | | - | 2.27 (i) a 30-day supply of the drug; or |
|---|
| 65 | | - | 2.28 (ii) a course of treatment lasting less than 30 days. |
|---|
| 66 | | - | 2.29 Subd. 3.Exemption.It is not a violation of this section for a wholesale distributor or |
|---|
| 67 | | - | 2.30pharmacy to increase the price of a generic or off-patent drug if the price increase is directly |
|---|
| 37 | + | Adoption of Report: Amended and re-referred to the Committee on State and Local Government Finance and Policy02/06/2023 2.1 Subd. 4.Manufacturer."Manufacturer" has the meaning provided in section 151.01, |
|---|
| 38 | + | 2.2subdivision 14a. |
|---|
| 39 | + | 2.3 Subd. 5.Prescription drug."Prescription drug" means a drug for human use subject |
|---|
| 40 | + | 2.4to United States Code, title 21, section 353(b)(1). |
|---|
| 41 | + | 2.5 Subd. 6.Wholesale acquisition cost."Wholesale acquisition cost" has the meaning |
|---|
| 42 | + | 2.6provided in United States Code, title 42, section 1395w-3a. |
|---|
| 43 | + | 2.7 Subd. 7.Wholesale distributor."Wholesale distributor" has the meaning provided in |
|---|
| 44 | + | 2.8section 151.441, subdivision 14. |
|---|
| 45 | + | 2.9 Sec. 2. [62J.842] EXCESSIVE PRICE INCREASES PROHIBITED. |
|---|
| 46 | + | 2.10 Subdivision 1.Prohibition.No manufacturer shall impose, or cause to be imposed, an |
|---|
| 47 | + | 2.11excessive price increase, whether directly or through a wholesale distributor, pharmacy, or |
|---|
| 48 | + | 2.12similar intermediary, on the sale of any generic or off-patent drug sold, dispensed, or |
|---|
| 49 | + | 2.13delivered to any consumer in the state. |
|---|
| 50 | + | 2.14 Subd. 2.Excessive price increase.A price increase is excessive for purposes of this |
|---|
| 51 | + | 2.15section when: |
|---|
| 52 | + | 2.16 (1) the price increase, adjusted for inflation utilizing the Consumer Price Index, exceeds: |
|---|
| 53 | + | 2.17 (i) 15 percent of the wholesale acquisition cost over the immediately preceding calendar |
|---|
| 54 | + | 2.18year; or |
|---|
| 55 | + | 2.19 (ii) 40 percent of the wholesale acquisition cost over the immediately preceding three |
|---|
| 56 | + | 2.20calendar years; and |
|---|
| 57 | + | 2.21 (2) the price increase, adjusted for inflation utilizing the Consumer Price Index, exceeds |
|---|
| 58 | + | 2.22$30 for: |
|---|
| 59 | + | 2.23 (i) a 30-day supply of the drug; or |
|---|
| 60 | + | 2.24 (ii) a course of treatment lasting less than 30 days. |
|---|
| 61 | + | 2.25 Subd. 3.Exemption.It is not a violation of this section for a wholesale distributor or |
|---|
| 62 | + | 2.26pharmacy to increase the price of a generic or off-patent drug if the price increase is directly |
|---|
| 63 | + | 2.27attributable to additional costs for the drug imposed on the wholesale distributor or pharmacy |
|---|
| 64 | + | 2.28by the manufacturer of the drug. |
|---|
| 69 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 3.1attributable to additional costs for the drug imposed on the wholesale distributor or pharmacy |
|---|
| 70 | | - | 3.2by the manufacturer of the drug. |
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| 71 | | - | 3.3 Sec. 3. [62J.843] REGISTERED AGENT AND OFFICE WITHIN THE STATE. |
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| 72 | | - | 3.4 Any manufacturer that sells, distributes, delivers, or offers for sale any generic or |
|---|
| 73 | | - | 3.5off-patent drug in the state must maintain a registered agent and office within the state. |
|---|
| 74 | | - | 3.6 Sec. 4. [62J.844] ENFORCEMENT . |
|---|
| 75 | | - | 3.7 Subdivision 1.Notification.(a) The commissioner of health shall notify the manufacturer |
|---|
| 76 | | - | 3.8of a generic or off-patent drug, the attorney general, and the Board of Pharmacy of any price |
|---|
| 77 | | - | 3.9increase that the commissioner believes may violate section 62J.842. |
|---|
| 78 | | - | 3.10 (b) The commissioner of management and budget and any other state agency that provides |
|---|
| 79 | | - | 3.11or purchases a pharmacy benefit except the Department of Human Services, and any entity |
|---|
| 80 | | - | 3.12under contract with a state agency to provide a pharmacy benefit other than an entity under |
|---|
| 81 | | - | 3.13contract with the Department of Human Services, may notify the manufacturer of a generic |
|---|
| 82 | | - | 3.14or off-patent drug, the attorney general, and the Board of Pharmacy of any price increase |
|---|
| 83 | | - | 3.15that the commissioner or entity believes may violate section 62J.842. |
|---|
| 84 | | - | 3.16 Subd. 2.Submission of drug cost statement and other information by manufacturer; |
|---|
| 85 | | - | 3.17investigation by attorney general.(a) Within 45 days of receiving a notice under subdivision |
|---|
| 86 | | - | 3.181, the manufacturer of the generic or off-patent drug shall submit a drug cost statement to |
|---|
| 87 | | - | 3.19the attorney general. The statement must: |
|---|
| 88 | | - | 3.20 (1) itemize the cost components related to production of the drug; |
|---|
| 89 | | - | 3.21 (2) identify the circumstances and timing of any increase in materials or manufacturing |
|---|
| 90 | | - | 3.22costs that caused any increase during the preceding calendar year, or preceding three calendar |
|---|
| 91 | | - | 3.23years as applicable, in the price of the drug; and |
|---|
| 92 | | - | 3.24 (3) provide any other information that the manufacturer believes to be relevant to a |
|---|
| 93 | | - | 3.25determination of whether a violation of section 62J.842 has occurred. |
|---|
| 94 | | - | 3.26 (b) The attorney general may investigate whether a violation of section 62J.842 has |
|---|
| 95 | | - | 3.27occurred, in accordance with section 8.31, subdivision 2. |
|---|
| 96 | | - | 3.28 Subd. 3.Petition to court.(a) On petition of the attorney general, a court may issue an |
|---|
| 97 | | - | 3.29order: |
|---|
| 98 | | - | 3.30 (1) compelling the manufacturer of a generic or off-patent drug to: |
|---|
| 99 | | - | 3.31 (i) provide the drug cost statement required under subdivision 2, paragraph (a); and |
|---|
| 66 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 3.1 Sec. 3. [62J.843] REGISTERED AGENT AND OFFICE WITHIN THE STATE. |
|---|
| 67 | + | 3.2 Any manufacturer that sells, distributes, delivers, or offers for sale any generic or |
|---|
| 68 | + | 3.3off-patent drug in the state must maintain a registered agent and office within the state. |
|---|
| 69 | + | 3.4 Sec. 4. [62J.844] ENFORCEMENT . |
|---|
| 70 | + | 3.5 Subdivision 1.Notification.The commissioner of management and budget and any |
|---|
| 71 | + | 3.6other state agency that provides or purchases a pharmacy benefit except the Department of |
|---|
| 72 | + | 3.7Human Services, and any entity under contract with a state agency to provide a pharmacy |
|---|
| 73 | + | 3.8benefit other than an entity under contract with the Department of Human Services, shall |
|---|
| 74 | + | 3.9notify the manufacturer of a generic or off-patent drug, the attorney general, and the Board |
|---|
| 75 | + | 3.10of Pharmacy of any price increase that the commissioner or entity believes may violate |
|---|
| 76 | + | 3.11section 62J.842. |
|---|
| 77 | + | 3.12 Subd. 2.Submission of drug cost statement and other information by manufacturer; |
|---|
| 78 | + | 3.13investigation by attorney general.(a) Within 45 days of receiving a notice under subdivision |
|---|
| 79 | + | 3.141, the manufacturer of the generic or off-patent drug shall submit a drug cost statement to |
|---|
| 80 | + | 3.15the attorney general. The statement must: |
|---|
| 81 | + | 3.16 (1) itemize the cost components related to production of the drug; |
|---|
| 82 | + | 3.17 (2) identify the circumstances and timing of any increase in materials or manufacturing |
|---|
| 83 | + | 3.18costs that caused any increase during the preceding calendar year, or preceding three calendar |
|---|
| 84 | + | 3.19years as applicable, in the price of the drug; and |
|---|
| 85 | + | 3.20 (3) provide any other information that the manufacturer believes to be relevant to a |
|---|
| 86 | + | 3.21determination of whether a violation of section 62J.842 has occurred. |
|---|
| 87 | + | 3.22 (b) The attorney general may investigate whether a violation of section 62J.842 has |
|---|
| 88 | + | 3.23occurred, in accordance with section 8.31, subdivision 2. |
|---|
| 89 | + | 3.24 Subd. 3.Petition to court.(a) On petition of the attorney general, a court may issue an |
|---|
| 90 | + | 3.25order: |
|---|
| 91 | + | 3.26 (1) compelling the manufacturer of a generic or off-patent drug to: |
|---|
| 92 | + | 3.27 (i) provide the drug cost statement required under subdivision 2, paragraph (a); and |
|---|
| 93 | + | 3.28 (ii) answer interrogatories, produce records or documents, or be examined under oath, |
|---|
| 94 | + | 3.29as required by the attorney general under subdivision 2, paragraph (b); |
|---|
| 95 | + | 3.30 (2) restraining or enjoining a violation of sections 62J.841 to 62J.845, including issuing |
|---|
| 96 | + | 3.31an order requiring that drug prices be restored to levels that comply with section 62J.842; |
|---|
| 101 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 4.1 (ii) answer interrogatories, produce records or documents, or be examined under oath, |
|---|
| 102 | | - | 4.2as required by the attorney general under subdivision 2, paragraph (b); |
|---|
| 103 | | - | 4.3 (2) restraining or enjoining a violation of sections 62J.841 to 62J.845, including issuing |
|---|
| 104 | | - | 4.4an order requiring that drug prices be restored to levels that comply with section 62J.842; |
|---|
| 105 | | - | 4.5 (3) requiring the manufacturer to provide an accounting to the attorney general of all |
|---|
| 106 | | - | 4.6revenues resulting from a violation of section 62J.842; |
|---|
| 107 | | - | 4.7 (4) requiring the manufacturer to repay to all Minnesota consumers, including any |
|---|
| 108 | | - | 4.8third-party payers, any money acquired as a result of a price increase that violates section |
|---|
| 109 | | - | 4.962J.842; |
|---|
| 110 | | - | 4.10 (5) notwithstanding section 16A.151, requiring that all revenues generated from a |
|---|
| 111 | | - | 4.11violation of section 62J.842 be remitted to the state and deposited into a special fund, to be |
|---|
| 112 | | - | 4.12used for initiatives to reduce the cost to consumers of acquiring prescription drugs, if a |
|---|
| 113 | | - | 4.13manufacturer is unable to determine the individual transactions necessary to provide the |
|---|
| 114 | | - | 4.14repayments described in clause (4); |
|---|
| 115 | | - | 4.15 (6) imposing a civil penalty of up to $10,000 per day for each violation of section 62J.842; |
|---|
| 116 | | - | 4.16 (7) providing for the attorney general's recovery of costs and disbursements incurred in |
|---|
| 117 | | - | 4.17bringing an action against a manufacturer found in violation of section 62J.842, including |
|---|
| 118 | | - | 4.18the costs of investigation and reasonable attorney's fees; and |
|---|
| 119 | | - | 4.19 (8) providing any other appropriate relief, including any other equitable relief as |
|---|
| 120 | | - | 4.20determined by the court. |
|---|
| 121 | | - | 4.21 (b) For purposes of paragraph (a), clause (6), every individual transaction in violation |
|---|
| 122 | | - | 4.22of section 62J.842 is considered a separate violation. |
|---|
| 123 | | - | 4.23 Subd. 4.Private right of action.Any action brought pursuant to section 8.31, subdivision |
|---|
| 124 | | - | 4.243a, by a person injured by a violation of section 62J.842 is for the benefit of the public. |
|---|
| 125 | | - | 4.25 Sec. 5. [62J.845] PROHIBITION ON WITHDRAWAL OF GENERIC OR |
|---|
| 126 | | - | 4.26OFF-PATENT DRUGS FOR SALE. |
|---|
| 127 | | - | 4.27 Subdivision 1.Prohibition.A manufacturer of a generic or off-patent drug is prohibited |
|---|
| 128 | | - | 4.28from withdrawing that drug from sale or distribution within this state for the purpose of |
|---|
| 129 | | - | 4.29avoiding the prohibition on excessive price increases under section 62J.842. |
|---|
| 130 | | - | 4.30 Subd. 2.Notice to board and attorney general.Any manufacturer that intends to |
|---|
| 131 | | - | 4.31withdraw a generic or off-patent drug from sale or distribution within the state shall provide |
|---|
| 98 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 4.1 (3) requiring the manufacturer to provide an accounting to the attorney general of all |
|---|
| 99 | + | 4.2revenues resulting from a violation of section 62J.842; |
|---|
| 100 | + | 4.3 (4) requiring the manufacturer to repay to all Minnesota consumers, including any |
|---|
| 101 | + | 4.4third-party payers, any money acquired as a result of a price increase that violates section |
|---|
| 102 | + | 4.562J.842; |
|---|
| 103 | + | 4.6 (5) notwithstanding section 16A.151, requiring that all revenues generated from a |
|---|
| 104 | + | 4.7violation of section 62J.842 be remitted to the state and deposited into a special fund, to be |
|---|
| 105 | + | 4.8used for initiatives to reduce the cost to consumers of acquiring prescription drugs, if a |
|---|
| 106 | + | 4.9manufacturer is unable to determine the individual transactions necessary to provide the |
|---|
| 107 | + | 4.10repayments described in clause (4); |
|---|
| 108 | + | 4.11 (6) imposing a civil penalty of up to $10,000 per day for each violation of section 62J.842; |
|---|
| 109 | + | 4.12 (7) providing for the attorney general's recovery of costs and disbursements incurred in |
|---|
| 110 | + | 4.13bringing an action against a manufacturer found in violation of section 62J.842, including |
|---|
| 111 | + | 4.14the costs of investigation and reasonable attorney's fees; and |
|---|
| 112 | + | 4.15 (8) providing any other appropriate relief, including any other equitable relief as |
|---|
| 113 | + | 4.16determined by the court. |
|---|
| 114 | + | 4.17 (b) For purposes of paragraph (a), clause (6), every individual transaction in violation |
|---|
| 115 | + | 4.18of section 62J.842 is considered a separate violation. |
|---|
| 116 | + | 4.19 Subd. 4.Private right of action.Any action brought pursuant to section 8.31, subdivision |
|---|
| 117 | + | 4.203a, by a person injured by a violation of section 62J.842 is for the benefit of the public. |
|---|
| 118 | + | 4.21 Sec. 5. [62J.845] PROHIBITION ON WITHDRAWAL OF GENERIC OR |
|---|
| 119 | + | 4.22OFF-PATENT DRUGS FOR SALE. |
|---|
| 120 | + | 4.23 Subdivision 1.Prohibition.A manufacturer of a generic or off-patent drug is prohibited |
|---|
| 121 | + | 4.24from withdrawing that drug from sale or distribution within this state for the purpose of |
|---|
| 122 | + | 4.25avoiding the prohibition on excessive price increases under section 62J.842. |
|---|
| 123 | + | 4.26 Subd. 2.Notice to board and attorney general.Any manufacturer that intends to |
|---|
| 124 | + | 4.27withdraw a generic or off-patent drug from sale or distribution within the state shall provide |
|---|
| 125 | + | 4.28a written notice of withdrawal to the Board of Pharmacy and the attorney general, at least |
|---|
| 126 | + | 4.2990 days prior to the withdrawal. |
|---|
| 127 | + | 4.30 Subd. 3.Financial penalty.The attorney general shall assess a penalty of $500,000 on |
|---|
| 128 | + | 4.31any manufacturer of a generic or off-patent drug that the attorney general determines has |
|---|
| 129 | + | 4.32failed to comply with the requirements of this section. |
|---|
| 163 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 6.1 (2) a biologics license application approved under United States Code, title 45, section |
|---|
| 164 | | - | 6.2262(a)(c). |
|---|
| 165 | | - | 6.3 Subd. 7.Generic drug."Generic drug" has the meaning provided in section 62J.84, |
|---|
| 166 | | - | 6.4subdivision 2, paragraph (e). |
|---|
| 167 | | - | 6.5 Subd. 8.Group purchaser."Group purchaser" has the meaning given in section 62J.03, |
|---|
| 168 | | - | 6.6subdivision 6, and includes pharmacy benefit managers as defined in section 62W.02, |
|---|
| 169 | | - | 6.7subdivision 15. |
|---|
| 170 | | - | 6.8 Subd. 9.Manufacturer."Manufacturer" means an entity that: |
|---|
| 171 | | - | 6.9 (1) engages in the manufacture of a prescription drug product or enters into a lease with |
|---|
| 172 | | - | 6.10another manufacturer to market and distribute a prescription drug product under the entity's |
|---|
| 173 | | - | 6.11own name; and |
|---|
| 174 | | - | 6.12 (2) sets or changes the wholesale acquisition cost of the prescription drug product it |
|---|
| 175 | | - | 6.13manufacturers or markets. |
|---|
| 176 | | - | 6.14 Subd. 10.Prescription drug product."Prescription drug product" means a brand name |
|---|
| 177 | | - | 6.15drug, a generic drug, a biologic, or a biosimilar. |
|---|
| 178 | | - | 6.16 Subd. 11.Wholesale acquisition cost or WAC."Wholesale acquisition cost" or "WAC" |
|---|
| 179 | | - | 6.17has the meaning given in United States Code, title 42, section 1395W-3a(c)(6)(B). |
|---|
| 180 | | - | 6.18 Sec. 9. [62J.87] PRESCRIPTION DRUG AFFORDABILITY BOARD. |
|---|
| 181 | | - | 6.19 Subdivision 1.Establishment.The commissioner of commerce shall establish the |
|---|
| 182 | | - | 6.20Prescription Drug Affordability Board, which shall be governed as a board under section |
|---|
| 183 | | - | 6.2115.012, paragraph (a), to protect consumers, state and local governments, health plan |
|---|
| 184 | | - | 6.22companies, providers, pharmacies, and other health care system stakeholders from |
|---|
| 185 | | - | 6.23unaffordable costs of certain prescription drugs. |
|---|
| 186 | | - | 6.24 Subd. 2.Membership.(a) The Prescription Drug Affordability Board consists of nine |
|---|
| 187 | | - | 6.25members appointed as follows: |
|---|
| 188 | | - | 6.26 (1) seven voting members appointed by the governor; |
|---|
| 189 | | - | 6.27 (2) one nonvoting member appointed by the majority leader of the senate; and |
|---|
| 190 | | - | 6.28 (3) one nonvoting member appointed by the speaker of the house. |
|---|
| 191 | | - | 6.29 (b) All members appointed must have knowledge and demonstrated expertise in |
|---|
| 192 | | - | 6.30pharmaceutical economics and finance or health care economics and finance. A member |
|---|
| 193 | | - | 6.31must not be an employee of, a board member of, or a consultant to a manufacturer or trade |
|---|
| 162 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 6.1 (2) sets or changes the wholesale acquisition cost of the prescription drug product it |
|---|
| 163 | + | 6.2manufacturers or markets. |
|---|
| 164 | + | 6.3 Subd. 10.Prescription drug product."Prescription drug product" means a brand name |
|---|
| 165 | + | 6.4drug, a generic drug, a biologic, or a biosimilar. |
|---|
| 166 | + | 6.5 Subd. 11.Wholesale acquisition cost or WAC."Wholesale acquisition cost" or "WAC" |
|---|
| 167 | + | 6.6has the meaning given in United States Code, title 42, section 1395W-3a(c)(6)(B). |
|---|
| 168 | + | 6.7 Sec. 9. [62J.87] PRESCRIPTION DRUG AFFORDABILITY BOARD. |
|---|
| 169 | + | 6.8 Subdivision 1.Establishment.The Legislative Coordinating Commission shall establish |
|---|
| 170 | + | 6.9the Prescription Drug Affordability Board, which shall be governed as a board under section |
|---|
| 171 | + | 6.1015.012, paragraph (a), to protect consumers, state and local governments, health plan |
|---|
| 172 | + | 6.11companies, providers, pharmacies, and other health care system stakeholders from |
|---|
| 173 | + | 6.12unaffordable costs of certain prescription drugs. |
|---|
| 174 | + | 6.13 Subd. 2.Membership.(a) The Prescription Drug Affordability Board consists of nine |
|---|
| 175 | + | 6.14members appointed as follows: |
|---|
| 176 | + | 6.15 (1) seven voting members appointed by the governor; |
|---|
| 177 | + | 6.16 (2) one nonvoting member appointed by the majority leader of the senate; and |
|---|
| 178 | + | 6.17 (3) one nonvoting member appointed by the speaker of the house. |
|---|
| 179 | + | 6.18 (b) All members appointed must have knowledge and demonstrated expertise in |
|---|
| 180 | + | 6.19pharmaceutical economics and finance or health care economics and finance. A member |
|---|
| 181 | + | 6.20must not be an employee of, a board member of, or a consultant to a manufacturer or trade |
|---|
| 182 | + | 6.21association for manufacturers or a pharmacy benefit manager or trade association for |
|---|
| 183 | + | 6.22pharmacy benefit managers. |
|---|
| 184 | + | 6.23 (c) Initial appointments must be made by January 1, 2024. |
|---|
| 185 | + | 6.24 Subd. 3.Terms.(a) Board appointees shall serve four-year terms, except that initial |
|---|
| 186 | + | 6.25appointees shall serve staggered terms of two, three, or four years as determined by lot by |
|---|
| 187 | + | 6.26the secretary of state. A board member shall serve no more than two consecutive terms. |
|---|
| 188 | + | 6.27 (b) A board member may resign at any time by giving written notice to the board. |
|---|
| 189 | + | 6.28 Subd. 4.Chair; other officers.(a) The governor shall designate an acting chair from |
|---|
| 190 | + | 6.29the members appointed by the governor. |
|---|
| 191 | + | 6.30 (b) The board shall elect a chair to replace the acting chair at the first meeting of the |
|---|
| 192 | + | 6.31board by a majority of the members. The chair shall serve for one year. |
|---|
| 195 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 7.1association for manufacturers or a pharmacy benefit manager or trade association for |
|---|
| 196 | | - | 7.2pharmacy benefit managers. |
|---|
| 197 | | - | 7.3 (c) Initial appointments must be made by January 1, 2024. |
|---|
| 198 | | - | 7.4 Subd. 3.Terms.(a) Board appointees shall serve four-year terms, except that initial |
|---|
| 199 | | - | 7.5appointees shall serve staggered terms of two, three, or four years as determined by lot by |
|---|
| 200 | | - | 7.6the secretary of state. A board member shall serve no more than two consecutive terms. |
|---|
| 201 | | - | 7.7 (b) A board member may resign at any time by giving written notice to the board. |
|---|
| 202 | | - | 7.8 Subd. 4.Chair; other officers.(a) The governor shall designate an acting chair from |
|---|
| 203 | | - | 7.9the members appointed by the governor. |
|---|
| 204 | | - | 7.10 (b) The board shall elect a chair to replace the acting chair at the first meeting of the |
|---|
| 205 | | - | 7.11board by a majority of the members. The chair shall serve for one year. |
|---|
| 206 | | - | 7.12 (c) The board shall elect a vice-chair and other officers from its membership as it deems |
|---|
| 207 | | - | 7.13necessary. |
|---|
| 208 | | - | 7.14 Subd. 5.Staff; technical assistance.(a) The board shall hire an executive director and |
|---|
| 209 | | - | 7.15other staff, who shall serve in the unclassified service. The executive director must have |
|---|
| 210 | | - | 7.16knowledge and demonstrated expertise in pharmacoeconomics, pharmacology, health policy, |
|---|
| 211 | | - | 7.17health services research, medicine, or a related field or discipline. |
|---|
| 212 | | - | 7.18 (b) The commissioner of health shall provide technical assistance to the board. The board |
|---|
| 213 | | - | 7.19may also employ or contract for professional and technical assistance as the board deems |
|---|
| 214 | | - | 7.20necessary to perform the board's duties. |
|---|
| 215 | | - | 7.21 (c) The attorney general shall provide legal services to the board. |
|---|
| 216 | | - | 7.22 Subd. 6.Compensation.The board members shall not receive compensation but may |
|---|
| 217 | | - | 7.23receive reimbursement for expenses as authorized under section 15.059, subdivision 3. |
|---|
| 218 | | - | 7.24 Subd. 7.Meetings.(a) Meetings of the board are subject to chapter 13D. The board shall |
|---|
| 219 | | - | 7.25meet publicly at least every three months to review prescription drug product information |
|---|
| 220 | | - | 7.26submitted to the board under section 62J.90. If there are no pending submissions, the chair |
|---|
| 221 | | - | 7.27of the board may cancel or postpone the required meeting. The board may meet in closed |
|---|
| 222 | | - | 7.28session when reviewing proprietary information as determined under the standards developed |
|---|
| 223 | | - | 7.29in accordance with section 62J.91, subdivision 3. |
|---|
| 224 | | - | 7.30 (b) The board shall announce each public meeting at least three weeks prior to the |
|---|
| 225 | | - | 7.31scheduled date of the meeting. Any materials for the meeting shall be made public at least |
|---|
| 226 | | - | 7.32two weeks prior to the scheduled date of the meeting. |
|---|
| 227 | | - | 7Sec. 9. |
|---|
| 228 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 8.1 (c) At each public meeting, the board shall provide the opportunity for comments from |
|---|
| 229 | | - | 8.2the public, including the opportunity for written comments to be submitted to the board |
|---|
| 230 | | - | 8.3prior to a decision by the board. |
|---|
| 231 | | - | 8.4 Sec. 10. [62J.88] PRESCRIPTION DRUG AFFORDABILITY ADVISORY |
|---|
| 232 | | - | 8.5COUNCIL. |
|---|
| 233 | | - | 8.6 Subdivision 1.Establishment.The governor shall appoint a 12-member stakeholder |
|---|
| 234 | | - | 8.7advisory council to provide advice to the board on drug cost issues and to represent |
|---|
| 235 | | - | 8.8stakeholders' views. The governor shall appoint the members of the advisory council based |
|---|
| 236 | | - | 8.9on the members' knowledge and demonstrated expertise in one or more of the following |
|---|
| 237 | | - | 8.10areas: the pharmaceutical business; practice of medicine; patient perspectives; health care |
|---|
| 238 | | - | 8.11cost trends and drivers; clinical and health services research; and the health care marketplace. |
|---|
| 239 | | - | 8.12 Subd. 2.Membership.The council's membership shall consist of the following: |
|---|
| 240 | | - | 8.13 (1) two members representing patients and health care consumers; |
|---|
| 241 | | - | 8.14 (2) two members representing health care providers; |
|---|
| 242 | | - | 8.15 (3) one member representing health plan companies; |
|---|
| 243 | | - | 8.16 (4) two members representing employers, with one member representing large employers |
|---|
| 244 | | - | 8.17and one member representing small employers; |
|---|
| 245 | | - | 8.18 (5) one member representing government employee benefit plans; |
|---|
| 246 | | - | 8.19 (6) one member representing pharmaceutical manufacturers; |
|---|
| 247 | | - | 8.20 (7) one member who is a health services clinical researcher; |
|---|
| 248 | | - | 8.21 (8) one member who is a pharmacologist; and |
|---|
| 249 | | - | 8.22 (9) one member representing the commissioner of health with expertise in health |
|---|
| 250 | | - | 8.23economics. |
|---|
| 251 | | - | 8.24 Subd. 3.Terms.(a) The initial appointments to the advisory council must be made by |
|---|
| 252 | | - | 8.25January 1, 2024. The initial appointed advisory council members shall serve staggered terms |
|---|
| 253 | | - | 8.26of two, three, or four years determined by lot by the secretary of state. Following the initial |
|---|
| 254 | | - | 8.27appointments, the advisory council members shall serve four-year terms. |
|---|
| 255 | | - | 8.28 (b) Removal and vacancies of advisory council members shall be governed by section |
|---|
| 256 | | - | 8.2915.059. |
|---|
| 257 | | - | 8.30 Subd. 4.Compensation.Advisory council members may be compensated according to |
|---|
| 258 | | - | 8.31section 15.059. |
|---|
| 259 | | - | 8Sec. 10. |
|---|
| 260 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 9.1 Subd. 5.Meetings.Meetings of the advisory council are subject to chapter 13D. The |
|---|
| 261 | | - | 9.2advisory council shall meet publicly at least every three months to advise the board on drug |
|---|
| 262 | | - | 9.3cost issues related to the prescription drug product information submitted to the board under |
|---|
| 263 | | - | 9.4section 62J.90. |
|---|
| 264 | | - | 9.5 Subd. 6.Exemption.Notwithstanding section 15.059, the advisory council shall not |
|---|
| 265 | | - | 9.6expire. |
|---|
| 266 | | - | 9.7 Sec. 11. [62J.89] CONFLICTS OF INTEREST. |
|---|
| 267 | | - | 9.8 Subdivision 1.Definition.For purposes of this section, "conflict of interest" means a |
|---|
| 268 | | - | 9.9financial or personal association that has the potential to bias or have the appearance of |
|---|
| 269 | | - | 9.10biasing a person's decisions in matters related to the board, the advisory council, or in the |
|---|
| 270 | | - | 9.11conduct of the board's or council's activities. A conflict of interest includes any instance in |
|---|
| 271 | | - | 9.12which a person, a person's immediate family member, including a spouse, parent, child, or |
|---|
| 272 | | - | 9.13other legal dependent, or an in-law of any of the preceding individuals, has received or |
|---|
| 273 | | - | 9.14could receive a direct or indirect financial benefit of any amount deriving from the result |
|---|
| 274 | | - | 9.15or findings of a decision or determination of the board. For purposes of this section, a |
|---|
| 275 | | - | 9.16financial benefit includes honoraria, fees, stock, the value of the member's, immediate family |
|---|
| 276 | | - | 9.17member's, or in-law's stock holdings, and any direct financial benefit deriving from the |
|---|
| 277 | | - | 9.18finding of a review conducted under sections 62J.85 to 62J.95. Ownership of securities is |
|---|
| 278 | | - | 9.19not a conflict of interest if the securities are: (1) part of a diversified mutual or exchange |
|---|
| 279 | | - | 9.20traded fund; or (2) in a tax-deferred or tax-exempt retirement account that is administered |
|---|
| 280 | | - | 9.21by an independent trustee. |
|---|
| 281 | | - | 9.22 Subd. 2.General.(a) Prior to the acceptance of an appointment or employment, or prior |
|---|
| 282 | | - | 9.23to entering into a contractual agreement, a board or advisory council member, board staff |
|---|
| 283 | | - | 9.24member, or third-party contractor must disclose to the appointing authority or the board |
|---|
| 284 | | - | 9.25any conflicts of interest. The information disclosed must include the type, nature, and |
|---|
| 285 | | - | 9.26magnitude of the interests involved. |
|---|
| 286 | | - | 9.27 (b) A board member, board staff member, or third-party contractor with a conflict of |
|---|
| 287 | | - | 9.28interest with regard to any prescription drug product under review must recuse themselves |
|---|
| 288 | | - | 9.29from any discussion, review, decision, or determination made by the board relating to the |
|---|
| 289 | | - | 9.30prescription drug product. |
|---|
| 290 | | - | 9.31 (c) Any conflict of interest must be disclosed in advance of the first meeting after the |
|---|
| 291 | | - | 9.32conflict is identified or within five days after the conflict is identified, whichever is earlier. |
|---|
| 292 | | - | 9Sec. 11. |
|---|
| 293 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 10.1 Subd. 3.Prohibitions.Board members, board staff, or third-party contractors are |
|---|
| 294 | | - | 10.2prohibited from accepting gifts, bequeaths, or donations of services or property that raise |
|---|
| 295 | | - | 10.3the specter of a conflict of interest or have the appearance of injecting bias into the activities |
|---|
| 296 | | - | 10.4of the board. |
|---|
| 297 | | - | 10.5 Sec. 12. [62J.90] PRESCRIPTION DRUG PRICE INFORMATION; DECISION |
|---|
| 298 | | - | 10.6TO CONDUCT COST REVIEW. |
|---|
| 299 | | - | 10.7 Subdivision 1.Drug price information from the commissioner of health and other |
|---|
| 300 | | - | 10.8sources.(a) The commissioner of health shall provide to the board the information reported |
|---|
| 301 | | - | 10.9to the commissioner by drug manufacturers under section 62J.84, subdivisions 3, 4, and 5. |
|---|
| 302 | | - | 10.10The commissioner shall provide this information to the board within 30 days of the date the |
|---|
| 303 | | - | 10.11information is received from drug manufacturers. |
|---|
| 304 | | - | 10.12 (b) The board may subscribe to one or more prescription drug pricing files, such as |
|---|
| 305 | | - | 10.13Medispan or FirstDatabank, or as otherwise determined by the board. |
|---|
| 306 | | - | 10.14 Subd. 2.Identification of certain prescription drug products.(a) The board, in |
|---|
| 307 | | - | 10.15consultation with the advisory council, shall identify selected prescription drug products |
|---|
| 308 | | - | 10.16based on the following criteria: |
|---|
| 309 | | - | 10.17 (1) brand name drugs or biologics for which the WAC increases by $3,000 during any |
|---|
| 310 | | - | 10.1812-month period or course of treatment if less than 12 months, after adjusting for changes |
|---|
| 311 | | - | 10.19in the consumer price index (CPI); |
|---|
| 312 | | - | 10.20 (2) brand name drugs or biologics with a WAC of $60,000 or more per calendar year |
|---|
| 313 | | - | 10.21or per course of treatment; |
|---|
| 314 | | - | 10.22 (3) biosimilar drugs that have a WAC that is not at least 20 percent lower than the |
|---|
| 315 | | - | 10.23referenced brand name biologic at the time the biosimilar is introduced; and |
|---|
| 316 | | - | 10.24 (4) generic drugs for which: |
|---|
| 317 | | - | 10.25 (i) the price increase, adjusted for inflation using the Consumer Price Index, as defined |
|---|
| 318 | | - | 10.26in section 62J.841, subdivision 2, exceeds: |
|---|
| 319 | | - | 10.27 (A) 15 percent of the wholesale acquisition cost over the immediately preceding calendar |
|---|
| 320 | | - | 10.28year; or |
|---|
| 321 | | - | 10.29 (B) 40 percent of the wholesale acquisition cost over the immediately preceding three |
|---|
| 322 | | - | 10.30calendar years; and |
|---|
| 323 | | - | 10.31 (ii) the price increase, adjusted for inflation utilizing the Consumer Price Index, exceeds |
|---|
| 324 | | - | 10.32$30 for: |
|---|
| 194 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 7.1 (c) The board shall elect a vice-chair and other officers from its membership as it deems |
|---|
| 195 | + | 7.2necessary. |
|---|
| 196 | + | 7.3 Subd. 5.Staff; technical assistance.(a) The board shall hire an executive director and |
|---|
| 197 | + | 7.4other staff, who shall serve in the unclassified service. The executive director must have |
|---|
| 198 | + | 7.5knowledge and demonstrated expertise in pharmacoeconomics, pharmacology, health policy, |
|---|
| 199 | + | 7.6health services research, medicine, or a related field or discipline. The board may employ |
|---|
| 200 | + | 7.7or contract for professional and technical assistance as the board deems necessary to perform |
|---|
| 201 | + | 7.8the board's duties. |
|---|
| 202 | + | 7.9 (b) The attorney general shall provide legal services to the board. |
|---|
| 203 | + | 7.10 Subd. 6.Compensation.The board members shall not receive compensation but may |
|---|
| 204 | + | 7.11receive reimbursement for expenses as authorized under section 15.059, subdivision 3. |
|---|
| 205 | + | 7.12 Subd. 7.Meetings.(a) Meetings of the board are subject to chapter 13D. The board shall |
|---|
| 206 | + | 7.13meet publicly at least every three months to review prescription drug product information |
|---|
| 207 | + | 7.14submitted to the board under section 62J.90. If there are no pending submissions, the chair |
|---|
| 208 | + | 7.15of the board may cancel or postpone the required meeting. The board may meet in closed |
|---|
| 209 | + | 7.16session when reviewing proprietary information as determined under the standards developed |
|---|
| 210 | + | 7.17in accordance with section 62J.91, subdivision 3. |
|---|
| 211 | + | 7.18 (b) The board shall announce each public meeting at least three weeks prior to the |
|---|
| 212 | + | 7.19scheduled date of the meeting. Any materials for the meeting shall be made public at least |
|---|
| 213 | + | 7.20two weeks prior to the scheduled date of the meeting. |
|---|
| 214 | + | 7.21 (c) At each public meeting, the board shall provide the opportunity for comments from |
|---|
| 215 | + | 7.22the public, including the opportunity for written comments to be submitted to the board |
|---|
| 216 | + | 7.23prior to a decision by the board. |
|---|
| 217 | + | 7.24 Sec. 10. [62J.88] PRESCRIPTION DRUG AFFORDABILITY ADVISORY |
|---|
| 218 | + | 7.25COUNCIL. |
|---|
| 219 | + | 7.26 Subdivision 1.Establishment.The governor shall appoint a 12-member stakeholder |
|---|
| 220 | + | 7.27advisory council to provide advice to the board on drug cost issues and to represent |
|---|
| 221 | + | 7.28stakeholders' views. The governor shall appoint the members of the advisory council based |
|---|
| 222 | + | 7.29on the members' knowledge and demonstrated expertise in one or more of the following |
|---|
| 223 | + | 7.30areas: the pharmaceutical business; practice of medicine; patient perspectives; health care |
|---|
| 224 | + | 7.31cost trends and drivers; clinical and health services research; and the health care marketplace. |
|---|
| 225 | + | 7.32 Subd. 2.Membership.The council's membership shall consist of the following: |
|---|
| 226 | + | 7Sec. 10. |
|---|
| 227 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 8.1 (1) two members representing patients and health care consumers; |
|---|
| 228 | + | 8.2 (2) two members representing health care providers; |
|---|
| 229 | + | 8.3 (3) one member representing health plan companies; |
|---|
| 230 | + | 8.4 (4) two members representing employers, with one member representing large employers |
|---|
| 231 | + | 8.5and one member representing small employers; |
|---|
| 232 | + | 8.6 (5) one member representing government employee benefit plans; |
|---|
| 233 | + | 8.7 (6) one member representing pharmaceutical manufacturers; |
|---|
| 234 | + | 8.8 (7) one member who is a health services clinical researcher; |
|---|
| 235 | + | 8.9 (8) one member who is a pharmacologist; and |
|---|
| 236 | + | 8.10 (9) one member representing the commissioner of health with expertise in health |
|---|
| 237 | + | 8.11economics. |
|---|
| 238 | + | 8.12 Subd. 3.Terms.(a) The initial appointments to the advisory council must be made by |
|---|
| 239 | + | 8.13January 1, 2024. The initial appointed advisory council members shall serve staggered terms |
|---|
| 240 | + | 8.14of two, three, or four years determined by lot by the secretary of state. Following the initial |
|---|
| 241 | + | 8.15appointments, the advisory council members shall serve four-year terms. |
|---|
| 242 | + | 8.16 (b) Removal and vacancies of advisory council members shall be governed by section |
|---|
| 243 | + | 8.1715.059. |
|---|
| 244 | + | 8.18 Subd. 4.Compensation.Advisory council members may be compensated according to |
|---|
| 245 | + | 8.19section 15.059. |
|---|
| 246 | + | 8.20 Subd. 5.Meetings.Meetings of the advisory council are subject to chapter 13D. The |
|---|
| 247 | + | 8.21advisory council shall meet publicly at least every three months to advise the board on drug |
|---|
| 248 | + | 8.22cost issues related to the prescription drug product information submitted to the board under |
|---|
| 249 | + | 8.23section 62J.90. |
|---|
| 250 | + | 8.24 Subd. 6.Exemption.Notwithstanding section 15.059, the advisory council shall not |
|---|
| 251 | + | 8.25expire. |
|---|
| 252 | + | 8.26 Sec. 11. [62J.89] CONFLICTS OF INTEREST. |
|---|
| 253 | + | 8.27 Subdivision 1.Definition.For purposes of this section, "conflict of interest" means a |
|---|
| 254 | + | 8.28financial or personal association that has the potential to bias or have the appearance of |
|---|
| 255 | + | 8.29biasing a person's decisions in matters related to the board, the advisory council, or in the |
|---|
| 256 | + | 8.30conduct of the board's or council's activities. A conflict of interest includes any instance in |
|---|
| 257 | + | 8.31which a person, a person's immediate family member, including a spouse, parent, child, or |
|---|
| 258 | + | 8Sec. 11. |
|---|
| 259 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 9.1other legal dependent, or an in-law of any of the preceding individuals, has received or |
|---|
| 260 | + | 9.2could receive a direct or indirect financial benefit of any amount deriving from the result |
|---|
| 261 | + | 9.3or findings of a decision or determination of the board. For purposes of this section, a |
|---|
| 262 | + | 9.4financial benefit includes honoraria, fees, stock, the value of the member's, immediate family |
|---|
| 263 | + | 9.5member's, or in-law's stock holdings, and any direct financial benefit deriving from the |
|---|
| 264 | + | 9.6finding of a review conducted under sections 62J.85 to 62J.95. Ownership of securities is |
|---|
| 265 | + | 9.7not a conflict of interest if the securities are: (1) part of a diversified mutual or exchange |
|---|
| 266 | + | 9.8traded fund; or (2) in a tax-deferred or tax-exempt retirement account that is administered |
|---|
| 267 | + | 9.9by an independent trustee. |
|---|
| 268 | + | 9.10 Subd. 2.General.(a) Prior to the acceptance of an appointment or employment, or prior |
|---|
| 269 | + | 9.11to entering into a contractual agreement, a board or advisory council member, board staff |
|---|
| 270 | + | 9.12member, or third-party contractor must disclose to the appointing authority or the board |
|---|
| 271 | + | 9.13any conflicts of interest. The information disclosed must include the type, nature, and |
|---|
| 272 | + | 9.14magnitude of the interests involved. |
|---|
| 273 | + | 9.15 (b) A board member, board staff member, or third-party contractor with a conflict of |
|---|
| 274 | + | 9.16interest with regard to any prescription drug product under review must recuse themselves |
|---|
| 275 | + | 9.17from any discussion, review, decision, or determination made by the board relating to the |
|---|
| 276 | + | 9.18prescription drug product. |
|---|
| 277 | + | 9.19 (c) Any conflict of interest must be disclosed in advance of the first meeting after the |
|---|
| 278 | + | 9.20conflict is identified or within five days after the conflict is identified, whichever is earlier. |
|---|
| 279 | + | 9.21 Subd. 3.Prohibitions.Board members, board staff, or third-party contractors are |
|---|
| 280 | + | 9.22prohibited from accepting gifts, bequeaths, or donations of services or property that raise |
|---|
| 281 | + | 9.23the specter of a conflict of interest or have the appearance of injecting bias into the activities |
|---|
| 282 | + | 9.24of the board. |
|---|
| 283 | + | 9.25 Sec. 12. [62J.90] PRESCRIPTION DRUG PRICE INFORMATION; DECISION |
|---|
| 284 | + | 9.26TO CONDUCT COST REVIEW. |
|---|
| 285 | + | 9.27 Subdivision 1.Drug price information from the commissioner of health and other |
|---|
| 286 | + | 9.28sources.(a) The commissioner of health shall provide to the board the information reported |
|---|
| 287 | + | 9.29to the commissioner by drug manufacturers under section 62J.84, subdivisions 3, 4, and 5. |
|---|
| 288 | + | 9.30The commissioner shall provide this information to the board within 30 days of the date the |
|---|
| 289 | + | 9.31information is received from drug manufacturers. |
|---|
| 290 | + | 9.32 (b) The board shall subscribe to one or more prescription drug pricing files, such as |
|---|
| 291 | + | 9.33Medispan or FirstDatabank, or as otherwise determined by the board. |
|---|
| 292 | + | 9Sec. 12. |
|---|
| 293 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 10.1 Subd. 2.Identification of certain prescription drug products.(a) The board, in |
|---|
| 294 | + | 10.2consultation with the advisory council, shall identify selected prescription drug products |
|---|
| 295 | + | 10.3based on the following criteria: |
|---|
| 296 | + | 10.4 (1) brand name drugs or biologics for which the WAC increases by $3,000 during any |
|---|
| 297 | + | 10.512-month period or course of treatment if less than 12 months, after adjusting for changes |
|---|
| 298 | + | 10.6in the consumer price index (CPI); |
|---|
| 299 | + | 10.7 (2) brand name drugs or biologics with a WAC of $60,000 or more per calendar year |
|---|
| 300 | + | 10.8or per course of treatment; |
|---|
| 301 | + | 10.9 (3) biosimilar drugs that have a WAC that is not at least 20 percent lower than the |
|---|
| 302 | + | 10.10referenced brand name biologic at the time the biosimilar is introduced; and |
|---|
| 303 | + | 10.11 (4) generic drugs for which the WAC: |
|---|
| 304 | + | 10.12 (i) is $100 or more, after adjusting for changes in the CPI, for: |
|---|
| 305 | + | 10.13 (A) a 30-day supply lasting a patient for 30 consecutive days based on the recommended |
|---|
| 306 | + | 10.14dosage approved for labeling by the United States Food and Drug Administration (FDA); |
|---|
| 307 | + | 10.15 (B) a supply lasting a patient for fewer than 30 days based on recommended dosage |
|---|
| 308 | + | 10.16approved for labeling by the FDA; or |
|---|
| 309 | + | 10.17 (C) one unit of the drug if the labeling approved by the FDA does not recommend a |
|---|
| 310 | + | 10.18finite dosage; and |
|---|
| 311 | + | 10.19 (ii) is increased by 200 percent or more during the immediate preceding 12-month period, |
|---|
| 312 | + | 10.20as determined by the difference between the resulting WAC and the average of the WAC |
|---|
| 313 | + | 10.21reported over the preceding 12 months, after adjusting for changes in the CPI. |
|---|
| 314 | + | 10.22 (b) The board, in consultation with the advisory council, may identify prescription drug |
|---|
| 315 | + | 10.23products not described in paragraph (a) that may impose costs that create significant |
|---|
| 316 | + | 10.24affordability challenges for the state health care system or for patients, including but not |
|---|
| 317 | + | 10.25limited to drugs to address public health emergencies. |
|---|
| 318 | + | 10.26 (c) The board shall make available to the public the names and related price information |
|---|
| 319 | + | 10.27of the prescription drug products identified under this subdivision, with the exception of |
|---|
| 320 | + | 10.28information determined by the board to be proprietary under the standards developed by |
|---|
| 321 | + | 10.29the board under section 62J.91, subdivision 3, and information provided by the commissioner |
|---|
| 322 | + | 10.30of health classified as not public data under section 13.02, subdivision 8a. |
|---|
| 323 | + | 10.31 Subd. 3.Determination to proceed with review.(a) The board may initiate a cost |
|---|
| 324 | + | 10.32review of a prescription drug product identified by the board under this section. |
|---|
| 326 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 11.1 (A) a 30-day supply of the drug; or |
|---|
| 327 | | - | 11.2 (B) a course of treatment lasting less than 30 days. |
|---|
| 328 | | - | 11.3The board is not required to identify all prescription drug products that meet the criteria in |
|---|
| 329 | | - | 11.4this paragraph. |
|---|
| 330 | | - | 11.5 (b) The board, in consultation with the advisory council and the commissioner of health, |
|---|
| 331 | | - | 11.6may identify prescription drug products not described in paragraph (a) that may impose |
|---|
| 332 | | - | 11.7costs that create significant affordability challenges for the state health care system or for |
|---|
| 333 | | - | 11.8patients, including but not limited to drugs to address public health emergencies. |
|---|
| 334 | | - | 11.9 (c) The board shall make available to the public the names and related price information |
|---|
| 335 | | - | 11.10of the prescription drug products identified under this subdivision, with the exception of |
|---|
| 336 | | - | 11.11information determined by the board to be proprietary under the standards developed by |
|---|
| 337 | | - | 11.12the board under section 62J.91, subdivision 3, and information provided by the commissioner |
|---|
| 338 | | - | 11.13of health classified as not public data under section 13.02, subdivision 8a, or as trade secret |
|---|
| 339 | | - | 11.14information under section 13.37, subdivision 1, paragraph (b), or as trade secret information |
|---|
| 340 | | - | 11.15under the Defend Trade Secrets Act of 2016, United States Code, title 18, section 1836, as |
|---|
| 341 | | - | 11.16amended. |
|---|
| 342 | | - | 11.17 Subd. 3.Determination to proceed with review.(a) The board may initiate a cost |
|---|
| 343 | | - | 11.18review of a prescription drug product identified by the board under this section. |
|---|
| 344 | | - | 11.19 (b) The board shall consider requests by the public for the board to proceed with a cost |
|---|
| 345 | | - | 11.20review of any prescription drug product identified under this section. |
|---|
| 346 | | - | 11.21 (c) If there is no consensus among the members of the board on whether to initiate a |
|---|
| 347 | | - | 11.22cost review of a prescription drug product, any member of the board may request a vote to |
|---|
| 348 | | - | 11.23determine whether to review the cost of the prescription drug product. |
|---|
| 349 | | - | 11.24Sec. 13. [62J.91] PRESCRIPTION DRUG PRODUCT REVIEWS. |
|---|
| 350 | | - | 11.25 Subdivision 1.General.Once a decision by the board has been made to proceed with |
|---|
| 351 | | - | 11.26a cost review of a prescription drug product, the board shall conduct the review and make |
|---|
| 352 | | - | 11.27a determination as to whether appropriate utilization of the prescription drug under review, |
|---|
| 353 | | - | 11.28based on utilization that is consistent with the United States Food and Drug Administration |
|---|
| 354 | | - | 11.29(FDA) label or standard medical practice, has led or will lead to affordability challenges |
|---|
| 355 | | - | 11.30for the state health care system or for patients. |
|---|
| 356 | | - | 11.31 Subd. 2.Review considerations.In reviewing the cost of a prescription drug product, |
|---|
| 357 | | - | 11.32the board may consider the following factors: |
|---|
| 326 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 11.1 (b) The board shall consider requests by the public for the board to proceed with a cost |
|---|
| 327 | + | 11.2review of any prescription drug product identified under this section. |
|---|
| 328 | + | 11.3 (c) If there is no consensus among the members of the board on whether to initiate a |
|---|
| 329 | + | 11.4cost review of a prescription drug product, any member of the board may request a vote to |
|---|
| 330 | + | 11.5determine whether to review the cost of the prescription drug product. |
|---|
| 331 | + | 11.6 Sec. 13. [62J.91] PRESCRIPTION DRUG PRODUCT REVIEWS. |
|---|
| 332 | + | 11.7 Subdivision 1.General.Once a decision by the board has been made to proceed with |
|---|
| 333 | + | 11.8a cost review of a prescription drug product, the board shall conduct the review and make |
|---|
| 334 | + | 11.9a determination as to whether appropriate utilization of the prescription drug under review, |
|---|
| 335 | + | 11.10based on utilization that is consistent with the United States Food and Drug Administration |
|---|
| 336 | + | 11.11(FDA) label or standard medical practice, has led or will lead to affordability challenges |
|---|
| 337 | + | 11.12for the state health care system or for patients. |
|---|
| 338 | + | 11.13 Subd. 2.Review considerations.In reviewing the cost of a prescription drug product, |
|---|
| 339 | + | 11.14the board may consider the following factors: |
|---|
| 340 | + | 11.15 (1) the price at which the prescription drug product has been and will be sold in the state; |
|---|
| 341 | + | 11.16 (2) manufacturer monetary price concessions, discounts, or rebates, and drug-specific |
|---|
| 342 | + | 11.17patient assistance; |
|---|
| 343 | + | 11.18 (3) the price of therapeutic alternatives; |
|---|
| 344 | + | 11.19 (4) the cost to group purchasers based on patient access consistent with the FDA-labeled |
|---|
| 345 | + | 11.20indications and standard medical practice; |
|---|
| 346 | + | 11.21 (5) measures of patient access, including cost-sharing and other metrics; |
|---|
| 347 | + | 11.22 (6) the extent to which the attorney general or a court has determined that a price increase |
|---|
| 348 | + | 11.23for a generic or off-patent prescription drug product was excessive under sections 62J.842 |
|---|
| 349 | + | 11.24and 62J.844; |
|---|
| 350 | + | 11.25 (7) any information a manufacturer chooses to provide; and |
|---|
| 351 | + | 11.26 (8) any other factors as determined by the board. |
|---|
| 352 | + | 11.27 Subd. 3.Public data; proprietary information.(a) Any submission made to the board |
|---|
| 353 | + | 11.28related to a drug cost review must be made available to the public with the exception of |
|---|
| 354 | + | 11.29information determined by the board to be proprietary and information provided by the |
|---|
| 355 | + | 11.30commissioner of health classified as not public data under section 13.02, subdivision 8a. |
|---|
| 359 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 12.1 (1) the price at which the prescription drug product has been and will be sold in the state; |
|---|
| 360 | | - | 12.2 (2) manufacturer monetary price concessions, discounts, or rebates, and drug-specific |
|---|
| 361 | | - | 12.3patient assistance; |
|---|
| 362 | | - | 12.4 (3) the price of therapeutic alternatives; |
|---|
| 363 | | - | 12.5 (4) the cost to group purchasers based on patient access consistent with the FDA-labeled |
|---|
| 364 | | - | 12.6indications and standard medical practice; |
|---|
| 365 | | - | 12.7 (5) measures of patient access, including cost-sharing and other metrics; |
|---|
| 366 | | - | 12.8 (6) the extent to which the attorney general or a court has determined that a price increase |
|---|
| 367 | | - | 12.9for a generic or off-patent prescription drug product was excessive under sections 62J.842 |
|---|
| 368 | | - | 12.10and 62J.844; |
|---|
| 369 | | - | 12.11 (7) any information a manufacturer chooses to provide; and |
|---|
| 370 | | - | 12.12 (8) any other factors as determined by the board. |
|---|
| 371 | | - | 12.13 Subd. 3.Public data; proprietary information.(a) Any submission made to the board |
|---|
| 372 | | - | 12.14related to a drug cost review must be made available to the public with the exception of |
|---|
| 373 | | - | 12.15information determined by the board to be proprietary and information provided by the |
|---|
| 374 | | - | 12.16commissioner of health classified as not public data under section 13.02, subdivision 8a, or |
|---|
| 375 | | - | 12.17as trade secret information under section 13.37, subdivision 1, paragraph (b), or as trade |
|---|
| 376 | | - | 12.18secret information under the Defend Trade Secrets Act of 2016, United States Code, title |
|---|
| 377 | | - | 12.1918, section 1836, as amended. |
|---|
| 378 | | - | 12.20 (b) The board shall establish the standards for the information to be considered proprietary |
|---|
| 379 | | - | 12.21under paragraph (a) and section 62J.90, subdivision 2, including standards for heightened |
|---|
| 380 | | - | 12.22consideration of proprietary information for submissions for a cost review of a drug that is |
|---|
| 381 | | - | 12.23not yet approved by the FDA. |
|---|
| 382 | | - | 12.24 (c) Prior to the board establishing the standards under paragraph (b), the public shall be |
|---|
| 383 | | - | 12.25provided notice and the opportunity to submit comments. |
|---|
| 384 | | - | 12.26 (d) The establishment of standards under this subdivision is exempt from the rulemaking |
|---|
| 385 | | - | 12.27requirements under chapter 14, and section 14.386 does not apply. |
|---|
| 386 | | - | 12.28Sec. 14. [62J.92] DETERMINATIONS; COMPLIANCE; REMEDIES. |
|---|
| 387 | | - | 12.29 Subdivision 1.Upper payment limit.(a) In the event the board finds that the spending |
|---|
| 388 | | - | 12.30on a prescription drug product reviewed under section 62J.91 creates an affordability |
|---|
| 357 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 12.1 (b) The board shall establish the standards for the information to be considered proprietary |
|---|
| 358 | + | 12.2under paragraph (a) and section 62J.90, subdivision 2, including standards for heightened |
|---|
| 359 | + | 12.3consideration of proprietary information for submissions for a cost review of a drug that is |
|---|
| 360 | + | 12.4not yet approved by the FDA. |
|---|
| 361 | + | 12.5 (c) Prior to the board establishing the standards under paragraph (b), the public shall be |
|---|
| 362 | + | 12.6provided notice and the opportunity to submit comments. |
|---|
| 363 | + | 12.7 (d) The establishment of standards under this subdivision is exempt from the rulemaking |
|---|
| 364 | + | 12.8requirements under chapter 14, and section 14.386 does not apply. |
|---|
| 365 | + | 12.9 Sec. 14. [62J.92] DETERMINATIONS; COMPLIANCE; REMEDIES. |
|---|
| 366 | + | 12.10 Subdivision 1.Upper payment limit.(a) In the event the board finds that the spending |
|---|
| 367 | + | 12.11on a prescription drug product reviewed under section 62J.91 creates an affordability |
|---|
| 368 | + | 12.12challenge for the state health care system or for patients, the board shall establish an upper |
|---|
| 369 | + | 12.13payment limit after considering: |
|---|
| 370 | + | 12.14 (1) extraordinary supply costs, if applicable; |
|---|
| 371 | + | 12.15 (2) the range of prices at which the drug is sold in the United States according to one or |
|---|
| 372 | + | 12.16more pricing files accessed under section 62J.90, subdivision 1, and the range at which |
|---|
| 373 | + | 12.17pharmacies are reimbursed in Canada; and |
|---|
| 374 | + | 12.18 (3) any other relevant pricing and administrative cost information for the drug. |
|---|
| 375 | + | 12.19 (b) The upper payment limit must apply to all state-regulated entity purchases, payments, |
|---|
| 376 | + | 12.20billing, and payer reimbursements for the prescription drug product that is intended for |
|---|
| 377 | + | 12.21individuals in the state in person, by mail, or by other means. |
|---|
| 378 | + | 12.22 Subd. 2.Implementation and administration of the upper payment limit.(a) An |
|---|
| 379 | + | 12.23upper payment limit may take effect no sooner than 120 days following the date of its public |
|---|
| 380 | + | 12.24release by the board. |
|---|
| 381 | + | 12.25 (b) When setting an upper payment limit for a drug subject to the Medicare maximum |
|---|
| 382 | + | 12.26fair price under United States Code, title 42, section 1191(c), the board shall set the upper |
|---|
| 383 | + | 12.27payment limit at the Medicare maximum fair price. |
|---|
| 384 | + | 12.28 (c) Pharmacy dispensing fees must not be counted toward or subject to any upper payment |
|---|
| 385 | + | 12.29limit. State-licensed independent pharmacies must not be reimbursed by health carriers and |
|---|
| 386 | + | 12.30pharmacy benefit managers at amounts that are less than the upper payment limit. |
|---|
| 387 | + | 12.31 (d) Health plan companies and pharmacy benefit managers shall report annually to the |
|---|
| 388 | + | 12.32board, in the form and manner specified by the board, on how cost savings resulting from |
|---|
| 390 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 13.1challenge for the state health care system or for patients, the board shall establish an upper |
|---|
| 391 | | - | 13.2payment limit after considering: |
|---|
| 392 | | - | 13.3 (1) extraordinary supply costs, if applicable; |
|---|
| 393 | | - | 13.4 (2) the range of prices at which the drug is sold in the United States according to one or |
|---|
| 394 | | - | 13.5more pricing files accessed under section 62J.90, subdivision 1, and the range at which |
|---|
| 395 | | - | 13.6pharmacies are reimbursed in Canada; and |
|---|
| 396 | | - | 13.7 (3) any other relevant pricing and administrative cost information for the drug. |
|---|
| 397 | | - | 13.8 (b) An upper payment limit applies to all purchases of, and payer reimbursements for, |
|---|
| 398 | | - | 13.9a prescription drug that is dispensed or administered to individuals in the state in person, |
|---|
| 399 | | - | 13.10by mail, or by other means, and for which an upper payment limit has been established. |
|---|
| 400 | | - | 13.11 Subd. 2.Implementation and administration of the upper payment limit.(a) An |
|---|
| 401 | | - | 13.12upper payment limit may take effect no sooner than 120 days following the date of its public |
|---|
| 402 | | - | 13.13release by the board. |
|---|
| 403 | | - | 13.14 (b) When setting an upper payment limit for a drug subject to the Medicare maximum |
|---|
| 404 | | - | 13.15fair price under United States Code, title 42, section 1191(c), the board shall set the upper |
|---|
| 405 | | - | 13.16payment limit at the Medicare maximum fair price. |
|---|
| 406 | | - | 13.17 (c) Pharmacy dispensing fees must not be counted toward or subject to any upper payment |
|---|
| 407 | | - | 13.18limit. State-licensed independent pharmacies must not be reimbursed by health carriers and |
|---|
| 408 | | - | 13.19pharmacy benefit managers at amounts that are less than the upper payment limit. |
|---|
| 409 | | - | 13.20 (d) Health plan companies and pharmacy benefit managers shall report annually to the |
|---|
| 410 | | - | 13.21board, in the form and manner specified by the board, on how cost savings resulting from |
|---|
| 411 | | - | 13.22the establishment of an upper payment limit have been used by the health plan company or |
|---|
| 412 | | - | 13.23pharmacy benefit manager to benefit enrollees, including but not limited to reducing enrollee |
|---|
| 413 | | - | 13.24cost-sharing. |
|---|
| 414 | | - | 13.25 Subd. 3.Noncompliance.(a) The board shall, and other persons may, notify the Office |
|---|
| 415 | | - | 13.26of the Attorney General of a potential failure by an entity subject to an upper payment limit |
|---|
| 416 | | - | 13.27to comply with that limit. |
|---|
| 417 | | - | 13.28 (b) If the Office of the Attorney General finds that an entity was noncompliant with the |
|---|
| 418 | | - | 13.29upper payment limit requirements, the attorney general may pursue remedies consistent |
|---|
| 419 | | - | 13.30with chapter 8 or appropriate criminal charges if there is evidence of intentional profiteering. |
|---|
| 420 | | - | 13Sec. 14. |
|---|
| 421 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 14.1 (c) An entity who obtains price concessions from a drug manufacturer that result in a |
|---|
| 422 | | - | 14.2lower net cost to the stakeholder than the upper payment limit established by the board is |
|---|
| 423 | | - | 14.3not considered noncompliant. |
|---|
| 424 | | - | 14.4 (d) The Office of the Attorney General may provide guidance to stakeholders concerning |
|---|
| 425 | | - | 14.5activities that could be considered noncompliant. |
|---|
| 426 | | - | 14.6 Subd. 4.Appeals.(a) Persons affected by a decision of the board may request an appeal |
|---|
| 427 | | - | 14.7of the board's decision within 30 days of the date of the decision. The board shall hear the |
|---|
| 428 | | - | 14.8appeal and render a decision within 60 days of the hearing. |
|---|
| 429 | | - | 14.9 (b) All appeal decisions are subject to judicial review in accordance with chapter 14. |
|---|
| 430 | | - | 14.10Sec. 15. [62J.93] REPORTS. |
|---|
| 431 | | - | 14.11 Beginning March 1, 2024, and each March 1 thereafter, the board shall submit a report |
|---|
| 432 | | - | 14.12to the governor and legislature on general price trends for prescription drug products and |
|---|
| 433 | | - | 14.13the number of prescription drug products that were subject to the board's cost review and |
|---|
| 434 | | - | 14.14analysis, including the result of any analysis as well as the number and disposition of appeals |
|---|
| 435 | | - | 14.15and judicial reviews. |
|---|
| 436 | | - | 14.16Sec. 16. [62J.94] ERISA PLANS AND MEDICARE DRUG PLANS. |
|---|
| 437 | | - | 14.17 (a) Nothing in sections 62J.85 to 62J.95 shall be construed to require ERISA plans or |
|---|
| 438 | | - | 14.18Medicare Part D plans to comply with decisions of the board. ERISA plans or Medicare |
|---|
| 439 | | - | 14.19Part D plans are free to choose to exceed the upper payment limit established by the board |
|---|
| 440 | | - | 14.20under section 62J.92. |
|---|
| 441 | | - | 14.21 (b) Providers who dispense and administer drugs in the state must bill all payers no more |
|---|
| 442 | | - | 14.22than the upper payment limit without regard to whether an ERISA plan or Medicare Part |
|---|
| 443 | | - | 14.23D plan chooses to reimburse the provider in an amount greater than the upper payment limit |
|---|
| 444 | | - | 14.24established by the board. |
|---|
| 445 | | - | 14.25 (c) For purposes of this section, an ERISA plan or group health plan is an employee |
|---|
| 446 | | - | 14.26welfare benefit plan established by or maintained by an employer or an employee |
|---|
| 447 | | - | 14.27organization, or both, that provides employer sponsored health coverage to employees and |
|---|
| 448 | | - | 14.28the employee's dependents and is subject to the Employee Retirement Income Security Act |
|---|
| 449 | | - | 14.29of 1974 (ERISA). |
|---|
| 450 | | - | 14Sec. 16. |
|---|
| 451 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 15.1 Sec. 17. [62J.95] SEVERABILITY. |
|---|
| 452 | | - | 15.2 If any provision of sections 62J.85 to 62J.94 or the application thereof to any person or |
|---|
| 453 | | - | 15.3circumstance is held invalid for any reason in a court of competent jurisdiction, the invalidity |
|---|
| 454 | | - | 15.4does not affect other provisions or any other application of sections 62J.85 to 62J.94 that |
|---|
| 455 | | - | 15.5can be given effect without the invalid provision or application. |
|---|
| 456 | | - | 15.6 Sec. 18. Minnesota Statutes 2022, section 151.071, subdivision 1, is amended to read: |
|---|
| 457 | | - | 15.7 Subdivision 1.Forms of disciplinary action.When the board finds that a licensee, |
|---|
| 458 | | - | 15.8registrant, or applicant has engaged in conduct prohibited under subdivision 2, it may do |
|---|
| 459 | | - | 15.9one or more of the following: |
|---|
| 460 | | - | 15.10 (1) deny the issuance of a license or registration; |
|---|
| 461 | | - | 15.11 (2) refuse to renew a license or registration; |
|---|
| 462 | | - | 15.12 (3) revoke the license or registration; |
|---|
| 463 | | - | 15.13 (4) suspend the license or registration; |
|---|
| 464 | | - | 15.14 (5) impose limitations, conditions, or both on the license or registration, including but |
|---|
| 465 | | - | 15.15not limited to: the limitation of practice to designated settings; the limitation of the scope |
|---|
| 466 | | - | 15.16of practice within designated settings; the imposition of retraining or rehabilitation |
|---|
| 467 | | - | 15.17requirements; the requirement of practice under supervision; the requirement of participation |
|---|
| 468 | | - | 15.18in a diversion program such as that established pursuant to section 214.31 or the conditioning |
|---|
| 469 | | - | 15.19of continued practice on demonstration of knowledge or skills by appropriate examination |
|---|
| 470 | | - | 15.20or other review of skill and competence; |
|---|
| 471 | | - | 15.21 (6) impose a civil penalty not exceeding $10,000 for each separate violation, except that |
|---|
| 472 | | - | 15.22a civil penalty not exceeding $25,000 may be imposed for each separate violation of section |
|---|
| 473 | | - | 15.2362J.842, the amount of the civil penalty to be fixed so as to deprive a licensee or registrant |
|---|
| 474 | | - | 15.24of any economic advantage gained by reason of the violation, to discourage similar violations |
|---|
| 475 | | - | 15.25by the licensee or registrant or any other licensee or registrant, or to reimburse the board |
|---|
| 476 | | - | 15.26for the cost of the investigation and proceeding, including but not limited to, fees paid for |
|---|
| 477 | | - | 15.27services provided by the Office of Administrative Hearings, legal and investigative services |
|---|
| 478 | | - | 15.28provided by the Office of the Attorney General, court reporters, witnesses, reproduction of |
|---|
| 479 | | - | 15.29records, board members' per diem compensation, board staff time, and travel costs and |
|---|
| 480 | | - | 15.30expenses incurred by board staff and board members; and |
|---|
| 481 | | - | 15.31 (7) reprimand the licensee or registrant. |
|---|
| 482 | | - | 15Sec. 18. |
|---|
| 483 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 16.1 Sec. 19. Minnesota Statutes 2022, section 151.071, subdivision 2, is amended to read: |
|---|
| 484 | | - | 16.2 Subd. 2.Grounds for disciplinary action.The following conduct is prohibited and is |
|---|
| 485 | | - | 16.3grounds for disciplinary action: |
|---|
| 486 | | - | 16.4 (1) failure to demonstrate the qualifications or satisfy the requirements for a license or |
|---|
| 487 | | - | 16.5registration contained in this chapter or the rules of the board. The burden of proof is on |
|---|
| 488 | | - | 16.6the applicant to demonstrate such qualifications or satisfaction of such requirements; |
|---|
| 489 | | - | 16.7 (2) obtaining a license by fraud or by misleading the board in any way during the |
|---|
| 490 | | - | 16.8application process or obtaining a license by cheating, or attempting to subvert the licensing |
|---|
| 491 | | - | 16.9examination process. Conduct that subverts or attempts to subvert the licensing examination |
|---|
| 492 | | - | 16.10process includes, but is not limited to: (i) conduct that violates the security of the examination |
|---|
| 493 | | - | 16.11materials, such as removing examination materials from the examination room or having |
|---|
| 494 | | - | 16.12unauthorized possession of any portion of a future, current, or previously administered |
|---|
| 495 | | - | 16.13licensing examination; (ii) conduct that violates the standard of test administration, such as |
|---|
| 496 | | - | 16.14communicating with another examinee during administration of the examination, copying |
|---|
| 497 | | - | 16.15another examinee's answers, permitting another examinee to copy one's answers, or |
|---|
| 498 | | - | 16.16possessing unauthorized materials; or (iii) impersonating an examinee or permitting an |
|---|
| 499 | | - | 16.17impersonator to take the examination on one's own behalf; |
|---|
| 500 | | - | 16.18 (3) for a pharmacist, pharmacy technician, pharmacist intern, applicant for a pharmacist |
|---|
| 501 | | - | 16.19or pharmacy license, or applicant for a pharmacy technician or pharmacist intern registration, |
|---|
| 502 | | - | 16.20conviction of a felony reasonably related to the practice of pharmacy. Conviction as used |
|---|
| 503 | | - | 16.21in this subdivision includes a conviction of an offense that if committed in this state would |
|---|
| 504 | | - | 16.22be deemed a felony without regard to its designation elsewhere, or a criminal proceeding |
|---|
| 505 | | - | 16.23where a finding or verdict of guilt is made or returned but the adjudication of guilt is either |
|---|
| 506 | | - | 16.24withheld or not entered thereon. The board may delay the issuance of a new license or |
|---|
| 507 | | - | 16.25registration if the applicant has been charged with a felony until the matter has been |
|---|
| 508 | | - | 16.26adjudicated; |
|---|
| 509 | | - | 16.27 (4) for a facility, other than a pharmacy, licensed or registered by the board, if an owner |
|---|
| 510 | | - | 16.28or applicant is convicted of a felony reasonably related to the operation of the facility. The |
|---|
| 511 | | - | 16.29board may delay the issuance of a new license or registration if the owner or applicant has |
|---|
| 512 | | - | 16.30been charged with a felony until the matter has been adjudicated; |
|---|
| 513 | | - | 16.31 (5) for a controlled substance researcher, conviction of a felony reasonably related to |
|---|
| 514 | | - | 16.32controlled substances or to the practice of the researcher's profession. The board may delay |
|---|
| 515 | | - | 16.33the issuance of a registration if the applicant has been charged with a felony until the matter |
|---|
| 516 | | - | 16.34has been adjudicated; |
|---|
| 390 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 13.1the establishment of an upper payment limit have been used by the health plan company or |
|---|
| 391 | + | 13.2pharmacy benefit manager to benefit enrollees, including but not limited to reducing enrollee |
|---|
| 392 | + | 13.3cost-sharing. |
|---|
| 393 | + | 13.4 Subd. 3.Noncompliance.(a) The board shall, and other persons may, notify the Office |
|---|
| 394 | + | 13.5of the Attorney General of a potential failure by an entity subject to an upper payment limit |
|---|
| 395 | + | 13.6to comply with that limit. |
|---|
| 396 | + | 13.7 (b) If the Office of the Attorney General finds that an entity was noncompliant with the |
|---|
| 397 | + | 13.8upper payment limit requirements, the attorney general may pursue remedies consistent |
|---|
| 398 | + | 13.9with chapter 8 or appropriate criminal charges if there is evidence of intentional profiteering. |
|---|
| 399 | + | 13.10 (c) An entity who obtains price concessions from a drug manufacturer that result in a |
|---|
| 400 | + | 13.11lower net cost to the stakeholder than the upper payment limit established by the board is |
|---|
| 401 | + | 13.12not considered noncompliant. |
|---|
| 402 | + | 13.13 (d) The Office of the Attorney General may provide guidance to stakeholders concerning |
|---|
| 403 | + | 13.14activities that could be considered noncompliant. |
|---|
| 404 | + | 13.15 Subd. 4.Appeals.(a) Persons affected by a decision of the board may request an appeal |
|---|
| 405 | + | 13.16of the board's decision within 30 days of the date of the decision. The board shall hear the |
|---|
| 406 | + | 13.17appeal and render a decision within 60 days of the hearing. |
|---|
| 407 | + | 13.18 (b) All appeal decisions are subject to judicial review in accordance with chapter 14. |
|---|
| 408 | + | 13.19Sec. 15. [62J.93] REPORTS. |
|---|
| 409 | + | 13.20 Beginning March 1, 2024, and each March 1 thereafter, the board shall submit a report |
|---|
| 410 | + | 13.21to the governor and legislature on general price trends for prescription drug products and |
|---|
| 411 | + | 13.22the number of prescription drug products that were subject to the board's cost review and |
|---|
| 412 | + | 13.23analysis, including the result of any analysis as well as the number and disposition of appeals |
|---|
| 413 | + | 13.24and judicial reviews. |
|---|
| 414 | + | 13.25Sec. 16. [62J.94] ERISA PLANS AND MEDICARE DRUG PLANS. |
|---|
| 415 | + | 13.26 (a) Nothing in sections 62J.85 to 62J.95 shall be construed to require ERISA plans or |
|---|
| 416 | + | 13.27Medicare Part D plans to comply with decisions of the board. ERISA plans or Medicare |
|---|
| 417 | + | 13.28Part D plans are free to choose to exceed the upper payment limit established by the board |
|---|
| 418 | + | 13.29under section 62J.92. |
|---|
| 419 | + | 13.30 (b) Providers who dispense and administer drugs in the state must bill all payers no more |
|---|
| 420 | + | 13.31than the upper payment limit without regard to whether an ERISA plan or Medicare Part |
|---|
| 421 | + | 13Sec. 16. |
|---|
| 422 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 14.1D plan chooses to reimburse the provider in an amount greater than the upper payment limit |
|---|
| 423 | + | 14.2established by the board. |
|---|
| 424 | + | 14.3 (c) For purposes of this section, an ERISA plan or group health plan is an employee |
|---|
| 425 | + | 14.4welfare benefit plan established by or maintained by an employer or an employee |
|---|
| 426 | + | 14.5organization, or both, that provides employer sponsored health coverage to employees and |
|---|
| 427 | + | 14.6the employee's dependents and is subject to the Employee Retirement Income Security Act |
|---|
| 428 | + | 14.7of 1974 (ERISA). |
|---|
| 429 | + | 14.8 Sec. 17. [62J.95] SEVERABILITY. |
|---|
| 430 | + | 14.9 If any provision of sections 62J.85 to 62J.94 or the application thereof to any person or |
|---|
| 431 | + | 14.10circumstance is held invalid for any reason in a court of competent jurisdiction, the invalidity |
|---|
| 432 | + | 14.11does not affect other provisions or any other application of sections 62J.85 to 62J.94 that |
|---|
| 433 | + | 14.12can be given effect without the invalid provision or application. |
|---|
| 434 | + | 14.13Sec. 18. Minnesota Statutes 2022, section 151.071, subdivision 1, is amended to read: |
|---|
| 435 | + | 14.14 Subdivision 1.Forms of disciplinary action.When the board finds that a licensee, |
|---|
| 436 | + | 14.15registrant, or applicant has engaged in conduct prohibited under subdivision 2, it may do |
|---|
| 437 | + | 14.16one or more of the following: |
|---|
| 438 | + | 14.17 (1) deny the issuance of a license or registration; |
|---|
| 439 | + | 14.18 (2) refuse to renew a license or registration; |
|---|
| 440 | + | 14.19 (3) revoke the license or registration; |
|---|
| 441 | + | 14.20 (4) suspend the license or registration; |
|---|
| 442 | + | 14.21 (5) impose limitations, conditions, or both on the license or registration, including but |
|---|
| 443 | + | 14.22not limited to: the limitation of practice to designated settings; the limitation of the scope |
|---|
| 444 | + | 14.23of practice within designated settings; the imposition of retraining or rehabilitation |
|---|
| 445 | + | 14.24requirements; the requirement of practice under supervision; the requirement of participation |
|---|
| 446 | + | 14.25in a diversion program such as that established pursuant to section 214.31 or the conditioning |
|---|
| 447 | + | 14.26of continued practice on demonstration of knowledge or skills by appropriate examination |
|---|
| 448 | + | 14.27or other review of skill and competence; |
|---|
| 449 | + | 14.28 (6) impose a civil penalty not exceeding $10,000 for each separate violation, except that |
|---|
| 450 | + | 14.29a civil penalty not exceeding $25,000 may be imposed for each separate violation of section |
|---|
| 451 | + | 14.3062J.842, the amount of the civil penalty to be fixed so as to deprive a licensee or registrant |
|---|
| 452 | + | 14.31of any economic advantage gained by reason of the violation, to discourage similar violations |
|---|
| 453 | + | 14Sec. 18. |
|---|
| 454 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 15.1by the licensee or registrant or any other licensee or registrant, or to reimburse the board |
|---|
| 455 | + | 15.2for the cost of the investigation and proceeding, including but not limited to, fees paid for |
|---|
| 456 | + | 15.3services provided by the Office of Administrative Hearings, legal and investigative services |
|---|
| 457 | + | 15.4provided by the Office of the Attorney General, court reporters, witnesses, reproduction of |
|---|
| 458 | + | 15.5records, board members' per diem compensation, board staff time, and travel costs and |
|---|
| 459 | + | 15.6expenses incurred by board staff and board members; and |
|---|
| 460 | + | 15.7 (7) reprimand the licensee or registrant. |
|---|
| 461 | + | 15.8 Sec. 19. Minnesota Statutes 2022, section 151.071, subdivision 2, is amended to read: |
|---|
| 462 | + | 15.9 Subd. 2.Grounds for disciplinary action.The following conduct is prohibited and is |
|---|
| 463 | + | 15.10grounds for disciplinary action: |
|---|
| 464 | + | 15.11 (1) failure to demonstrate the qualifications or satisfy the requirements for a license or |
|---|
| 465 | + | 15.12registration contained in this chapter or the rules of the board. The burden of proof is on |
|---|
| 466 | + | 15.13the applicant to demonstrate such qualifications or satisfaction of such requirements; |
|---|
| 467 | + | 15.14 (2) obtaining a license by fraud or by misleading the board in any way during the |
|---|
| 468 | + | 15.15application process or obtaining a license by cheating, or attempting to subvert the licensing |
|---|
| 469 | + | 15.16examination process. Conduct that subverts or attempts to subvert the licensing examination |
|---|
| 470 | + | 15.17process includes, but is not limited to: (i) conduct that violates the security of the examination |
|---|
| 471 | + | 15.18materials, such as removing examination materials from the examination room or having |
|---|
| 472 | + | 15.19unauthorized possession of any portion of a future, current, or previously administered |
|---|
| 473 | + | 15.20licensing examination; (ii) conduct that violates the standard of test administration, such as |
|---|
| 474 | + | 15.21communicating with another examinee during administration of the examination, copying |
|---|
| 475 | + | 15.22another examinee's answers, permitting another examinee to copy one's answers, or |
|---|
| 476 | + | 15.23possessing unauthorized materials; or (iii) impersonating an examinee or permitting an |
|---|
| 477 | + | 15.24impersonator to take the examination on one's own behalf; |
|---|
| 478 | + | 15.25 (3) for a pharmacist, pharmacy technician, pharmacist intern, applicant for a pharmacist |
|---|
| 479 | + | 15.26or pharmacy license, or applicant for a pharmacy technician or pharmacist intern registration, |
|---|
| 480 | + | 15.27conviction of a felony reasonably related to the practice of pharmacy. Conviction as used |
|---|
| 481 | + | 15.28in this subdivision includes a conviction of an offense that if committed in this state would |
|---|
| 482 | + | 15.29be deemed a felony without regard to its designation elsewhere, or a criminal proceeding |
|---|
| 483 | + | 15.30where a finding or verdict of guilt is made or returned but the adjudication of guilt is either |
|---|
| 484 | + | 15.31withheld or not entered thereon. The board may delay the issuance of a new license or |
|---|
| 485 | + | 15.32registration if the applicant has been charged with a felony until the matter has been |
|---|
| 486 | + | 15.33adjudicated; |
|---|
| 487 | + | 15Sec. 19. |
|---|
| 488 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 16.1 (4) for a facility, other than a pharmacy, licensed or registered by the board, if an owner |
|---|
| 489 | + | 16.2or applicant is convicted of a felony reasonably related to the operation of the facility. The |
|---|
| 490 | + | 16.3board may delay the issuance of a new license or registration if the owner or applicant has |
|---|
| 491 | + | 16.4been charged with a felony until the matter has been adjudicated; |
|---|
| 492 | + | 16.5 (5) for a controlled substance researcher, conviction of a felony reasonably related to |
|---|
| 493 | + | 16.6controlled substances or to the practice of the researcher's profession. The board may delay |
|---|
| 494 | + | 16.7the issuance of a registration if the applicant has been charged with a felony until the matter |
|---|
| 495 | + | 16.8has been adjudicated; |
|---|
| 496 | + | 16.9 (6) disciplinary action taken by another state or by one of this state's health licensing |
|---|
| 497 | + | 16.10agencies: |
|---|
| 498 | + | 16.11 (i) revocation, suspension, restriction, limitation, or other disciplinary action against a |
|---|
| 499 | + | 16.12license or registration in another state or jurisdiction, failure to report to the board that |
|---|
| 500 | + | 16.13charges or allegations regarding the person's license or registration have been brought in |
|---|
| 501 | + | 16.14another state or jurisdiction, or having been refused a license or registration by any other |
|---|
| 502 | + | 16.15state or jurisdiction. The board may delay the issuance of a new license or registration if an |
|---|
| 503 | + | 16.16investigation or disciplinary action is pending in another state or jurisdiction until the |
|---|
| 504 | + | 16.17investigation or action has been dismissed or otherwise resolved; and |
|---|
| 505 | + | 16.18 (ii) revocation, suspension, restriction, limitation, or other disciplinary action against a |
|---|
| 506 | + | 16.19license or registration issued by another of this state's health licensing agencies, failure to |
|---|
| 507 | + | 16.20report to the board that charges regarding the person's license or registration have been |
|---|
| 508 | + | 16.21brought by another of this state's health licensing agencies, or having been refused a license |
|---|
| 509 | + | 16.22or registration by another of this state's health licensing agencies. The board may delay the |
|---|
| 510 | + | 16.23issuance of a new license or registration if a disciplinary action is pending before another |
|---|
| 511 | + | 16.24of this state's health licensing agencies until the action has been dismissed or otherwise |
|---|
| 512 | + | 16.25resolved; |
|---|
| 513 | + | 16.26 (7) for a pharmacist, pharmacy, pharmacy technician, or pharmacist intern, violation of |
|---|
| 514 | + | 16.27any order of the board, of any of the provisions of this chapter or any rules of the board or |
|---|
| 515 | + | 16.28violation of any federal, state, or local law or rule reasonably pertaining to the practice of |
|---|
| 516 | + | 16.29pharmacy; |
|---|
| 517 | + | 16.30 (8) for a facility, other than a pharmacy, licensed by the board, violations of any order |
|---|
| 518 | + | 16.31of the board, of any of the provisions of this chapter or the rules of the board or violation |
|---|
| 519 | + | 16.32of any federal, state, or local law relating to the operation of the facility; |
|---|
| 520 | + | 16.33 (9) engaging in any unethical conduct; conduct likely to deceive, defraud, or harm the |
|---|
| 521 | + | 16.34public, or demonstrating a willful or careless disregard for the health, welfare, or safety of |
|---|
| 518 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 17.1 (6) disciplinary action taken by another state or by one of this state's health licensing |
|---|
| 519 | | - | 17.2agencies: |
|---|
| 520 | | - | 17.3 (i) revocation, suspension, restriction, limitation, or other disciplinary action against a |
|---|
| 521 | | - | 17.4license or registration in another state or jurisdiction, failure to report to the board that |
|---|
| 522 | | - | 17.5charges or allegations regarding the person's license or registration have been brought in |
|---|
| 523 | | - | 17.6another state or jurisdiction, or having been refused a license or registration by any other |
|---|
| 524 | | - | 17.7state or jurisdiction. The board may delay the issuance of a new license or registration if an |
|---|
| 525 | | - | 17.8investigation or disciplinary action is pending in another state or jurisdiction until the |
|---|
| 526 | | - | 17.9investigation or action has been dismissed or otherwise resolved; and |
|---|
| 527 | | - | 17.10 (ii) revocation, suspension, restriction, limitation, or other disciplinary action against a |
|---|
| 528 | | - | 17.11license or registration issued by another of this state's health licensing agencies, failure to |
|---|
| 529 | | - | 17.12report to the board that charges regarding the person's license or registration have been |
|---|
| 530 | | - | 17.13brought by another of this state's health licensing agencies, or having been refused a license |
|---|
| 531 | | - | 17.14or registration by another of this state's health licensing agencies. The board may delay the |
|---|
| 532 | | - | 17.15issuance of a new license or registration if a disciplinary action is pending before another |
|---|
| 533 | | - | 17.16of this state's health licensing agencies until the action has been dismissed or otherwise |
|---|
| 534 | | - | 17.17resolved; |
|---|
| 535 | | - | 17.18 (7) for a pharmacist, pharmacy, pharmacy technician, or pharmacist intern, violation of |
|---|
| 536 | | - | 17.19any order of the board, of any of the provisions of this chapter or any rules of the board or |
|---|
| 537 | | - | 17.20violation of any federal, state, or local law or rule reasonably pertaining to the practice of |
|---|
| 538 | | - | 17.21pharmacy; |
|---|
| 539 | | - | 17.22 (8) for a facility, other than a pharmacy, licensed by the board, violations of any order |
|---|
| 540 | | - | 17.23of the board, of any of the provisions of this chapter or the rules of the board or violation |
|---|
| 541 | | - | 17.24of any federal, state, or local law relating to the operation of the facility; |
|---|
| 542 | | - | 17.25 (9) engaging in any unethical conduct; conduct likely to deceive, defraud, or harm the |
|---|
| 543 | | - | 17.26public, or demonstrating a willful or careless disregard for the health, welfare, or safety of |
|---|
| 544 | | - | 17.27a patient; or pharmacy practice that is professionally incompetent, in that it may create |
|---|
| 545 | | - | 17.28unnecessary danger to any patient's life, health, or safety, in any of which cases, proof of |
|---|
| 546 | | - | 17.29actual injury need not be established; |
|---|
| 547 | | - | 17.30 (10) aiding or abetting an unlicensed person in the practice of pharmacy, except that it |
|---|
| 548 | | - | 17.31is not a violation of this clause for a pharmacist to supervise a properly registered pharmacy |
|---|
| 549 | | - | 17.32technician or pharmacist intern if that person is performing duties allowed by this chapter |
|---|
| 550 | | - | 17.33or the rules of the board; |
|---|
| 523 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 17.1a patient; or pharmacy practice that is professionally incompetent, in that it may create |
|---|
| 524 | + | 17.2unnecessary danger to any patient's life, health, or safety, in any of which cases, proof of |
|---|
| 525 | + | 17.3actual injury need not be established; |
|---|
| 526 | + | 17.4 (10) aiding or abetting an unlicensed person in the practice of pharmacy, except that it |
|---|
| 527 | + | 17.5is not a violation of this clause for a pharmacist to supervise a properly registered pharmacy |
|---|
| 528 | + | 17.6technician or pharmacist intern if that person is performing duties allowed by this chapter |
|---|
| 529 | + | 17.7or the rules of the board; |
|---|
| 530 | + | 17.8 (11) for an individual licensed or registered by the board, adjudication as mentally ill |
|---|
| 531 | + | 17.9or developmentally disabled, or as a chemically dependent person, a person dangerous to |
|---|
| 532 | + | 17.10the public, a sexually dangerous person, or a person who has a sexual psychopathic |
|---|
| 533 | + | 17.11personality, by a court of competent jurisdiction, within or without this state. Such |
|---|
| 534 | + | 17.12adjudication shall automatically suspend a license for the duration thereof unless the board |
|---|
| 535 | + | 17.13orders otherwise; |
|---|
| 536 | + | 17.14 (12) for a pharmacist or pharmacy intern, engaging in unprofessional conduct as specified |
|---|
| 537 | + | 17.15in the board's rules. In the case of a pharmacy technician, engaging in conduct specified in |
|---|
| 538 | + | 17.16board rules that would be unprofessional if it were engaged in by a pharmacist or pharmacist |
|---|
| 539 | + | 17.17intern or performing duties specifically reserved for pharmacists under this chapter or the |
|---|
| 540 | + | 17.18rules of the board; |
|---|
| 541 | + | 17.19 (13) for a pharmacy, operation of the pharmacy without a pharmacist present and on |
|---|
| 542 | + | 17.20duty except as allowed by a variance approved by the board; |
|---|
| 543 | + | 17.21 (14) for a pharmacist, the inability to practice pharmacy with reasonable skill and safety |
|---|
| 544 | + | 17.22to patients by reason of illness, use of alcohol, drugs, narcotics, chemicals, or any other type |
|---|
| 545 | + | 17.23of material or as a result of any mental or physical condition, including deterioration through |
|---|
| 546 | + | 17.24the aging process or loss of motor skills. In the case of registered pharmacy technicians, |
|---|
| 547 | + | 17.25pharmacist interns, or controlled substance researchers, the inability to carry out duties |
|---|
| 548 | + | 17.26allowed under this chapter or the rules of the board with reasonable skill and safety to |
|---|
| 549 | + | 17.27patients by reason of illness, use of alcohol, drugs, narcotics, chemicals, or any other type |
|---|
| 550 | + | 17.28of material or as a result of any mental or physical condition, including deterioration through |
|---|
| 551 | + | 17.29the aging process or loss of motor skills; |
|---|
| 552 | + | 17.30 (15) for a pharmacist, pharmacy, pharmacist intern, pharmacy technician, medical gas |
|---|
| 553 | + | 17.31dispenser, or controlled substance researcher, revealing a privileged communication from |
|---|
| 554 | + | 17.32or relating to a patient except when otherwise required or permitted by law; |
|---|
| 552 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 18.1 (11) for an individual licensed or registered by the board, adjudication as mentally ill |
|---|
| 553 | | - | 18.2or developmentally disabled, or as a chemically dependent person, a person dangerous to |
|---|
| 554 | | - | 18.3the public, a sexually dangerous person, or a person who has a sexual psychopathic |
|---|
| 555 | | - | 18.4personality, by a court of competent jurisdiction, within or without this state. Such |
|---|
| 556 | | - | 18.5adjudication shall automatically suspend a license for the duration thereof unless the board |
|---|
| 557 | | - | 18.6orders otherwise; |
|---|
| 558 | | - | 18.7 (12) for a pharmacist or pharmacy intern, engaging in unprofessional conduct as specified |
|---|
| 559 | | - | 18.8in the board's rules. In the case of a pharmacy technician, engaging in conduct specified in |
|---|
| 560 | | - | 18.9board rules that would be unprofessional if it were engaged in by a pharmacist or pharmacist |
|---|
| 561 | | - | 18.10intern or performing duties specifically reserved for pharmacists under this chapter or the |
|---|
| 562 | | - | 18.11rules of the board; |
|---|
| 563 | | - | 18.12 (13) for a pharmacy, operation of the pharmacy without a pharmacist present and on |
|---|
| 564 | | - | 18.13duty except as allowed by a variance approved by the board; |
|---|
| 565 | | - | 18.14 (14) for a pharmacist, the inability to practice pharmacy with reasonable skill and safety |
|---|
| 566 | | - | 18.15to patients by reason of illness, use of alcohol, drugs, narcotics, chemicals, or any other type |
|---|
| 567 | | - | 18.16of material or as a result of any mental or physical condition, including deterioration through |
|---|
| 568 | | - | 18.17the aging process or loss of motor skills. In the case of registered pharmacy technicians, |
|---|
| 569 | | - | 18.18pharmacist interns, or controlled substance researchers, the inability to carry out duties |
|---|
| 570 | | - | 18.19allowed under this chapter or the rules of the board with reasonable skill and safety to |
|---|
| 571 | | - | 18.20patients by reason of illness, use of alcohol, drugs, narcotics, chemicals, or any other type |
|---|
| 572 | | - | 18.21of material or as a result of any mental or physical condition, including deterioration through |
|---|
| 573 | | - | 18.22the aging process or loss of motor skills; |
|---|
| 574 | | - | 18.23 (15) for a pharmacist, pharmacy, pharmacist intern, pharmacy technician, medical gas |
|---|
| 575 | | - | 18.24dispenser, or controlled substance researcher, revealing a privileged communication from |
|---|
| 576 | | - | 18.25or relating to a patient except when otherwise required or permitted by law; |
|---|
| 577 | | - | 18.26 (16) for a pharmacist or pharmacy, improper management of patient records, including |
|---|
| 578 | | - | 18.27failure to maintain adequate patient records, to comply with a patient's request made pursuant |
|---|
| 579 | | - | 18.28to sections 144.291 to 144.298, or to furnish a patient record or report required by law; |
|---|
| 580 | | - | 18.29 (17) fee splitting, including without limitation: |
|---|
| 581 | | - | 18.30 (i) paying, offering to pay, receiving, or agreeing to receive, a commission, rebate, |
|---|
| 582 | | - | 18.31kickback, or other form of remuneration, directly or indirectly, for the referral of patients; |
|---|
| 583 | | - | 18.32 (ii) referring a patient to any health care provider as defined in sections 144.291 to |
|---|
| 584 | | - | 18.33144.298 in which the licensee or registrant has a financial or economic interest as defined |
|---|
| 556 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 18.1 (16) for a pharmacist or pharmacy, improper management of patient records, including |
|---|
| 557 | + | 18.2failure to maintain adequate patient records, to comply with a patient's request made pursuant |
|---|
| 558 | + | 18.3to sections 144.291 to 144.298, or to furnish a patient record or report required by law; |
|---|
| 559 | + | 18.4 (17) fee splitting, including without limitation: |
|---|
| 560 | + | 18.5 (i) paying, offering to pay, receiving, or agreeing to receive, a commission, rebate, |
|---|
| 561 | + | 18.6kickback, or other form of remuneration, directly or indirectly, for the referral of patients; |
|---|
| 562 | + | 18.7 (ii) referring a patient to any health care provider as defined in sections 144.291 to |
|---|
| 563 | + | 18.8144.298 in which the licensee or registrant has a financial or economic interest as defined |
|---|
| 564 | + | 18.9in section 144.6521, subdivision 3, unless the licensee or registrant has disclosed the |
|---|
| 565 | + | 18.10licensee's or registrant's financial or economic interest in accordance with section 144.6521; |
|---|
| 566 | + | 18.11and |
|---|
| 567 | + | 18.12 (iii) any arrangement through which a pharmacy, in which the prescribing practitioner |
|---|
| 568 | + | 18.13does not have a significant ownership interest, fills a prescription drug order and the |
|---|
| 569 | + | 18.14prescribing practitioner is involved in any manner, directly or indirectly, in setting the price |
|---|
| 570 | + | 18.15for the filled prescription that is charged to the patient, the patient's insurer or pharmacy |
|---|
| 571 | + | 18.16benefit manager, or other person paying for the prescription or, in the case of veterinary |
|---|
| 572 | + | 18.17patients, the price for the filled prescription that is charged to the client or other person |
|---|
| 573 | + | 18.18paying for the prescription, except that a veterinarian and a pharmacy may enter into such |
|---|
| 574 | + | 18.19an arrangement provided that the client or other person paying for the prescription is notified, |
|---|
| 575 | + | 18.20in writing and with each prescription dispensed, about the arrangement, unless such |
|---|
| 576 | + | 18.21arrangement involves pharmacy services provided for livestock, poultry, and agricultural |
|---|
| 577 | + | 18.22production systems, in which case client notification would not be required; |
|---|
| 578 | + | 18.23 (18) engaging in abusive or fraudulent billing practices, including violations of the |
|---|
| 579 | + | 18.24federal Medicare and Medicaid laws or state medical assistance laws or rules; |
|---|
| 580 | + | 18.25 (19) engaging in conduct with a patient that is sexual or may reasonably be interpreted |
|---|
| 581 | + | 18.26by the patient as sexual, or in any verbal behavior that is seductive or sexually demeaning |
|---|
| 582 | + | 18.27to a patient; |
|---|
| 583 | + | 18.28 (20) failure to make reports as required by section 151.072 or to cooperate with an |
|---|
| 584 | + | 18.29investigation of the board as required by section 151.074; |
|---|
| 585 | + | 18.30 (21) knowingly providing false or misleading information that is directly related to the |
|---|
| 586 | + | 18.31care of a patient unless done for an accepted therapeutic purpose such as the dispensing and |
|---|
| 587 | + | 18.32administration of a placebo; |
|---|
| 586 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 19.1in section 144.6521, subdivision 3, unless the licensee or registrant has disclosed the |
|---|
| 587 | | - | 19.2licensee's or registrant's financial or economic interest in accordance with section 144.6521; |
|---|
| 588 | | - | 19.3and |
|---|
| 589 | | - | 19.4 (iii) any arrangement through which a pharmacy, in which the prescribing practitioner |
|---|
| 590 | | - | 19.5does not have a significant ownership interest, fills a prescription drug order and the |
|---|
| 591 | | - | 19.6prescribing practitioner is involved in any manner, directly or indirectly, in setting the price |
|---|
| 592 | | - | 19.7for the filled prescription that is charged to the patient, the patient's insurer or pharmacy |
|---|
| 593 | | - | 19.8benefit manager, or other person paying for the prescription or, in the case of veterinary |
|---|
| 594 | | - | 19.9patients, the price for the filled prescription that is charged to the client or other person |
|---|
| 595 | | - | 19.10paying for the prescription, except that a veterinarian and a pharmacy may enter into such |
|---|
| 596 | | - | 19.11an arrangement provided that the client or other person paying for the prescription is notified, |
|---|
| 597 | | - | 19.12in writing and with each prescription dispensed, about the arrangement, unless such |
|---|
| 598 | | - | 19.13arrangement involves pharmacy services provided for livestock, poultry, and agricultural |
|---|
| 599 | | - | 19.14production systems, in which case client notification would not be required; |
|---|
| 600 | | - | 19.15 (18) engaging in abusive or fraudulent billing practices, including violations of the |
|---|
| 601 | | - | 19.16federal Medicare and Medicaid laws or state medical assistance laws or rules; |
|---|
| 602 | | - | 19.17 (19) engaging in conduct with a patient that is sexual or may reasonably be interpreted |
|---|
| 603 | | - | 19.18by the patient as sexual, or in any verbal behavior that is seductive or sexually demeaning |
|---|
| 604 | | - | 19.19to a patient; |
|---|
| 605 | | - | 19.20 (20) failure to make reports as required by section 151.072 or to cooperate with an |
|---|
| 606 | | - | 19.21investigation of the board as required by section 151.074; |
|---|
| 607 | | - | 19.22 (21) knowingly providing false or misleading information that is directly related to the |
|---|
| 608 | | - | 19.23care of a patient unless done for an accepted therapeutic purpose such as the dispensing and |
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| 609 | | - | 19.24administration of a placebo; |
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| 610 | | - | 19.25 (22) aiding suicide or aiding attempted suicide in violation of section 609.215 as |
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| 611 | | - | 19.26established by any of the following: |
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| 612 | | - | 19.27 (i) a copy of the record of criminal conviction or plea of guilty for a felony in violation |
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| 613 | | - | 19.28of section 609.215, subdivision 1 or 2; |
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| 614 | | - | 19.29 (ii) a copy of the record of a judgment of contempt of court for violating an injunction |
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| 615 | | - | 19.30issued under section 609.215, subdivision 4; |
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| 616 | | - | 19.31 (iii) a copy of the record of a judgment assessing damages under section 609.215, |
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| 617 | | - | 19.32subdivision 5; or |
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| 618 | | - | 19Sec. 19. |
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| 619 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT 20.1 (iv) a finding by the board that the person violated section 609.215, subdivision 1 or 2. |
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| 620 | | - | 20.2The board must investigate any complaint of a violation of section 609.215, subdivision 1 |
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| 621 | | - | 20.3or 2; |
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| 622 | | - | 20.4 (23) for a pharmacist, practice of pharmacy under a lapsed or nonrenewed license. For |
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| 623 | | - | 20.5a pharmacist intern, pharmacy technician, or controlled substance researcher, performing |
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| 624 | | - | 20.6duties permitted to such individuals by this chapter or the rules of the board under a lapsed |
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| 625 | | - | 20.7or nonrenewed registration. For a facility required to be licensed under this chapter, operation |
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| 626 | | - | 20.8of the facility under a lapsed or nonrenewed license or registration; and |
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| 627 | | - | 20.9 (24) for a pharmacist, pharmacist intern, or pharmacy technician, termination or discharge |
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| 628 | | - | 20.10from the health professionals services program for reasons other than the satisfactory |
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| 629 | | - | 20.11completion of the program.; and |
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| 630 | | - | 20.12 (25) for a manufacturer, a violation of section 62J.842 or section 62J.845. |
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| 631 | | - | 20.13Sec. 20. APPROPRIATION. |
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| 632 | | - | 20.14 $....... in fiscal year 2024 and $....... in fiscal year 2025 are appropriated from the general |
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| 633 | | - | 20.15fund to the Prescription Drug Affordability Board established under Minnesota Statutes, |
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| 634 | | - | 20.16section 62J.87, for implementation of the Prescription Drug Affordability Act. |
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| 635 | | - | 20Sec. 20. |
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| 636 | | - | REVISOR SGS H0017-3HF17 THIRD ENGROSSMENT |
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| 589 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT 19.1 (22) aiding suicide or aiding attempted suicide in violation of section 609.215 as |
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| 590 | + | 19.2established by any of the following: |
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| 591 | + | 19.3 (i) a copy of the record of criminal conviction or plea of guilty for a felony in violation |
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| 592 | + | 19.4of section 609.215, subdivision 1 or 2; |
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| 593 | + | 19.5 (ii) a copy of the record of a judgment of contempt of court for violating an injunction |
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| 594 | + | 19.6issued under section 609.215, subdivision 4; |
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| 595 | + | 19.7 (iii) a copy of the record of a judgment assessing damages under section 609.215, |
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| 596 | + | 19.8subdivision 5; or |
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| 597 | + | 19.9 (iv) a finding by the board that the person violated section 609.215, subdivision 1 or 2. |
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| 598 | + | 19.10The board must investigate any complaint of a violation of section 609.215, subdivision 1 |
|---|
| 599 | + | 19.11or 2; |
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| 600 | + | 19.12 (23) for a pharmacist, practice of pharmacy under a lapsed or nonrenewed license. For |
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| 601 | + | 19.13a pharmacist intern, pharmacy technician, or controlled substance researcher, performing |
|---|
| 602 | + | 19.14duties permitted to such individuals by this chapter or the rules of the board under a lapsed |
|---|
| 603 | + | 19.15or nonrenewed registration. For a facility required to be licensed under this chapter, operation |
|---|
| 604 | + | 19.16of the facility under a lapsed or nonrenewed license or registration; and |
|---|
| 605 | + | 19.17 (24) for a pharmacist, pharmacist intern, or pharmacy technician, termination or discharge |
|---|
| 606 | + | 19.18from the health professionals services program for reasons other than the satisfactory |
|---|
| 607 | + | 19.19completion of the program.; and |
|---|
| 608 | + | 19.20 (25) for a manufacturer, a violation of section 62J.842 or section 62J.845. |
|---|
| 609 | + | 19.21Sec. 20. APPROPRIATION. |
|---|
| 610 | + | 19.22 $....... in fiscal year 2024 and $....... in fiscal year 2025 are appropriated from the general |
|---|
| 611 | + | 19.23fund to the Prescription Drug Affordability Board established under Minnesota Statutes, |
|---|
| 612 | + | 19.24section 62J.87, for implementation of the Prescription Drug Affordability Act. |
|---|
| 613 | + | 19Sec. 20. |
|---|
| 614 | + | REVISOR SGS H0017-2HF17 SECOND ENGROSSMENT |
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