1 | 1 | | 1.1 A bill for an act |
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2 | 2 | | 1.2 relating to health insurance; requiring coverage of over-the-counter contraceptive |
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3 | 3 | | 1.3 drugs, devices, and products by insurers and medical assistance; requiring reports; |
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4 | 4 | | 1.4 amending Minnesota Statutes 2024, sections 62Q.522, subdivisions 1, 2; |
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5 | 5 | | 1.5 256B.0625, subdivision 13. |
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6 | 6 | | 1.6BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: |
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7 | 7 | | 1.7 Section 1. Minnesota Statutes 2024, section 62Q.522, subdivision 1, is amended to read: |
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8 | 8 | | 1.8 Subdivision 1.Definitions.(a) The definitions in this subdivision apply to this section. |
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9 | 9 | | 1.9 (b) "Contraceptive method" means a drug, device, or other product approved by the |
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10 | 10 | | 1.10Food and Drug Administration to prevent unintended pregnancy prescription contraceptive |
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11 | 11 | | 1.11or over-the-counter contraceptive. |
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12 | 12 | | 1.12 (c) "Contraceptive service" or "service" means consultation, examination, procedures, |
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13 | 13 | | 1.13and medical services related to the prevention of unintended pregnancy, excluding |
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14 | 14 | | 1.14vasectomies. This includes but is not limited to voluntary sterilization procedures, patient |
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15 | 15 | | 1.15education, counseling on contraceptives, and follow-up services related to contraceptive |
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16 | 16 | | 1.16methods or services, management of side effects, counseling for continued adherence, and |
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17 | 17 | | 1.17device insertion or removal. |
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18 | 18 | | 1.18 (d) "Medical necessity" includes but is not limited to considerations such as severity of |
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19 | 19 | | 1.19side effects, difference in permanence and reversibility of a contraceptive method or service, |
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20 | 20 | | 1.20and ability to adhere to the appropriate use of the contraceptive method or service, as |
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21 | 21 | | 1.21determined by the attending provider. |
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22 | 22 | | 1.22 (e) "Over-the-counter contraceptive" or "OTC contraceptive" means a drug, device, or |
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23 | 23 | | 1.23other product that: |
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24 | 24 | | 1Section 1. |
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25 | 25 | | REVISOR RSI/HL 25-0242501/29/25 |
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26 | 26 | | State of Minnesota |
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27 | 27 | | This Document can be made available |
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28 | 28 | | in alternative formats upon request |
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29 | 29 | | HOUSE OF REPRESENTATIVES |
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30 | 30 | | H. F. No. 1485 |
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31 | 31 | | NINETY-FOURTH SESSION 2.1 (1) is approved by the Food and Drug Administration to prevent unintended pregnancy; |
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32 | 32 | | 2.2and |
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33 | 33 | | 2.3 (2) does not require a prescription. |
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34 | 34 | | 2.4 (f) "Pharmacy" has the meaning given in section 151.01. |
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35 | 35 | | 2.5 (g) "Prescription contraceptive" means a drug, device, or other product that: |
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36 | 36 | | 2.6 (1) is approved by the Food and Drug Administration to prevent unintended pregnancy; |
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37 | 37 | | 2.7and |
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38 | 38 | | 2.8 (2) requires a prescription. |
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39 | 39 | | 2.9 (e) (h) "Therapeutic equivalent version" means a drug, device, or product that can be |
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40 | 40 | | 2.10expected to have the same clinical effect and safety profile when administered to a patient |
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41 | 41 | | 2.11under the conditions specified in the labeling, and that: |
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42 | 42 | | 2.12 (1) is approved as safe and effective; |
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43 | 43 | | 2.13 (2) is a pharmaceutical equivalent: (i) containing identical amounts of the same active |
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44 | 44 | | 2.14drug ingredient in the same dosage form and route of administration; and (ii) meeting |
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45 | 45 | | 2.15compendial or other applicable standards of strength, quality, purity, and identity; |
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46 | 46 | | 2.16 (3) is bioequivalent in that: |
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47 | 47 | | 2.17 (i) the drug, device, or product does not present a known or potential bioequivalence |
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48 | 48 | | 2.18problem and meets an acceptable in vitro standard; or |
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49 | 49 | | 2.19 (ii) if the drug, device, or product does present a known or potential bioequivalence |
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50 | 50 | | 2.20problem, it is shown to meet an appropriate bioequivalence standard; |
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51 | 51 | | 2.21 (4) is adequately labeled; and |
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52 | 52 | | 2.22 (5) is manufactured in compliance with current manufacturing practice regulations. |
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53 | 53 | | 2.23 EFFECTIVE DATE.This section is effective January 1, 2026, and applies to health |
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54 | 54 | | 2.24plans offered, issued, or renewed on or after that date. |
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55 | 55 | | 2.25 Sec. 2. Minnesota Statutes 2024, section 62Q.522, subdivision 2, is amended to read: |
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56 | 56 | | 2.26 Subd. 2.Required coverage; cost sharing prohibited.(a) A health plan must provide |
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57 | 57 | | 2.27coverage for contraceptive methods and services. |
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58 | 58 | | 2.28 (b) A health plan company must not impose cost-sharing requirements, including co-pays, |
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59 | 59 | | 2.29deductibles, or coinsurance, for contraceptive methods or services. |
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60 | 60 | | 2Sec. 2. |
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61 | 61 | | REVISOR RSI/HL 25-0242501/29/25 3.1 (c) A health plan company must not impose any referral requirements, restrictions, or |
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62 | 62 | | 3.2delays for contraceptive methods or services. |
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63 | 63 | | 3.3 (d) A health plan must include at least one of each type of Food and Drug Administration |
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64 | 64 | | 3.4approved contraceptive method in its formulary. Subject to paragraph (g), if more than one |
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65 | 65 | | 3.5therapeutic equivalent version of a contraceptive method is approved, a health plan must |
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66 | 66 | | 3.6include at least one therapeutic equivalent version in its formulary, but is not required to |
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67 | 67 | | 3.7include all therapeutic equivalent versions. |
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68 | 68 | | 3.8 (e) For each health plan, a health plan company must list the contraceptive methods and |
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69 | 69 | | 3.9services that are covered without cost-sharing in a manner that is easily accessible to |
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70 | 70 | | 3.10enrollees, health care providers, and representatives of health care providers. The list for |
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71 | 71 | | 3.11each health plan must be promptly updated to reflect changes to the coverage. |
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72 | 72 | | 3.12 (f) If an enrollee's attending provider recommends a particular contraceptive method or |
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73 | 73 | | 3.13service based on a determination of medical necessity for that enrollee, the health plan must |
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74 | 74 | | 3.14cover that contraceptive method or service without cost-sharing. The health plan company |
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75 | 75 | | 3.15issuing the health plan must defer to the attending provider's determination that the particular |
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76 | 76 | | 3.16contraceptive method or service is medically necessary for the enrollee. |
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77 | 77 | | 3.17 (g) Notwithstanding paragraph (d), a health plan must cover all types and brands of OTC |
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78 | 78 | | 3.18contraceptives purchased at a pharmacy without requiring a prescription. |
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79 | 79 | | 3.19 (h) A health plan must cover all OTC contraceptives purchased at a pharmacy at the |
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80 | 80 | | 3.20point-of-sale without requiring a prescription. |
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81 | 81 | | 3.21 (i) A health plan must not limit the type, quantity, or purchase frequency, and must not |
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82 | 82 | | 3.22impose any restriction or requirement, based on prescription status of OTC contraceptives |
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83 | 83 | | 3.23purchased at a pharmacy. |
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84 | 84 | | 3.24 (j) If the application of this subdivision before an enrollee has met the enrollee's health |
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85 | 85 | | 3.25plan's deductible results in: (1) health savings account ineligibility under United States |
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86 | 86 | | 3.26Code, title 26, section 223; or (2) catastrophic health plan ineligibility under United States |
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87 | 87 | | 3.27Code, title 42, section 18022(e), then this subdivision applies to contraceptive methods and |
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88 | 88 | | 3.28services only after the enrollee has met the enrollee's health plan's deductible. |
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89 | 89 | | 3.29 EFFECTIVE DATE.This section is effective January 1, 2026, and applies to health |
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90 | 90 | | 3.30plans offered, issued, or renewed on or after that date. |
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91 | 91 | | 3Sec. 2. |
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92 | 92 | | REVISOR RSI/HL 25-0242501/29/25 4.1 Sec. 3. Minnesota Statutes 2024, section 256B.0625, subdivision 13, is amended to read: |
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93 | 93 | | 4.2 Subd. 13.Drugs.(a) Medical assistance covers drugs, except for fertility drugs when |
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94 | 94 | | 4.3specifically used to enhance fertility, if prescribed by a licensed practitioner and dispensed |
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95 | 95 | | 4.4by a licensed pharmacist, by a physician enrolled in the medical assistance program as a |
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96 | 96 | | 4.5dispensing physician, or by a physician, a physician assistant, or an advanced practice |
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97 | 97 | | 4.6registered nurse employed by or under contract with a community health board as defined |
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98 | 98 | | 4.7in section 145A.02, subdivision 5, for the purposes of communicable disease control. |
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99 | 99 | | 4.8 (b) The dispensed quantity of a prescription drug must not exceed a 34-day supply unless |
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100 | 100 | | 4.9authorized by the commissioner or as provided in paragraph (h) or the drug appears on the |
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101 | 101 | | 4.1090-day supply list published by the commissioner. The 90-day supply list shall be published |
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102 | 102 | | 4.11by the commissioner on the department's website. The commissioner may add to, delete |
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103 | 103 | | 4.12from, and otherwise modify the 90-day supply list after providing public notice and the |
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104 | 104 | | 4.13opportunity for a 15-day public comment period. The 90-day supply list may include |
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105 | 105 | | 4.14cost-effective generic drugs and shall not include controlled substances. |
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106 | 106 | | 4.15 (c) For the purpose of this subdivision and subdivision 13d, an "active pharmaceutical |
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107 | 107 | | 4.16ingredient" is defined as a substance that is represented for use in a drug and when used in |
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108 | 108 | | 4.17the manufacturing, processing, or packaging of a drug becomes an active ingredient of the |
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109 | 109 | | 4.18drug product. An "excipient" is defined as an inert substance used as a diluent or vehicle |
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110 | 110 | | 4.19for a drug. The commissioner shall establish a list of active pharmaceutical ingredients and |
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111 | 111 | | 4.20excipients which are included in the medical assistance formulary. Medical assistance covers |
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112 | 112 | | 4.21selected active pharmaceutical ingredients and excipients used in compounded prescriptions |
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113 | 113 | | 4.22when the compounded combination is specifically approved by the commissioner or when |
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114 | 114 | | 4.23a commercially available product: |
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115 | 115 | | 4.24 (1) is not a therapeutic option for the patient; |
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116 | 116 | | 4.25 (2) does not exist in the same combination of active ingredients in the same strengths |
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117 | 117 | | 4.26as the compounded prescription; and |
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118 | 118 | | 4.27 (3) cannot be used in place of the active pharmaceutical ingredient in the compounded |
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119 | 119 | | 4.28prescription. |
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120 | 120 | | 4.29 (d) Medical assistance covers the following over-the-counter drugs: |
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121 | 121 | | 4.30 (1) when prescribed by a licensed practitioner or by a licensed pharmacist who meets |
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122 | 122 | | 4.31standards established by the commissioner, in consultation with the board of pharmacy: |
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123 | 123 | | 4.32 (i) antacids,; |
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124 | 124 | | 4.33 (ii) acetaminophen,; |
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125 | 125 | | 4Sec. 3. |
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126 | 126 | | REVISOR RSI/HL 25-0242501/29/25 5.1 (iii) family planning products,; |
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127 | 127 | | 5.2 (iv) aspirin,; |
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128 | 128 | | 5.3 (v) insulin,; |
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129 | 129 | | 5.4 (vi) products for the treatment of lice,; |
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130 | 130 | | 5.5 (vii) vitamins for adults with documented vitamin deficiencies,; |
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131 | 131 | | 5.6 (viii) vitamins for children under the age of seven and pregnant or nursing women,; and |
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132 | 132 | | 5.7 (ix) any other over-the-counter drug identified by the commissioner, in consultation |
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133 | 133 | | 5.8with the Formulary Committee, as necessary, appropriate, and cost-effective for the treatment |
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134 | 134 | | 5.9of certain specified chronic diseases, conditions, or disorders,; and this |
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135 | 135 | | 5.10 (2) all over-the-counter contraceptives, as defined in section 62Q.522, regardless of |
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136 | 136 | | 5.11whether the drug has been prescribed. |
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137 | 137 | | 5.12A determination shall by the commissioner under clause (1), item (ix), is not be subject to |
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138 | 138 | | 5.13the requirements of chapter 14. A pharmacist may prescribe over-the-counter medications |
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139 | 139 | | 5.14as provided under this paragraph for purposes of receiving reimbursement under Medicaid. |
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140 | 140 | | 5.15When prescribing over-the-counter drugs under this paragraph, licensed pharmacists must |
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141 | 141 | | 5.16consult with the recipient to determine necessity, provide drug counseling, review drug |
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142 | 142 | | 5.17therapy for potential adverse interactions, and make referrals as needed to other health care |
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143 | 143 | | 5.18professionals. |
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144 | 144 | | 5.19 (e) Effective January 1, 2006, medical assistance shall not cover drugs that are coverable |
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145 | 145 | | 5.20under Medicare Part D as defined in the Medicare Prescription Drug, Improvement, and |
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146 | 146 | | 5.21Modernization Act of 2003, Public Law 108-173, section 1860D-2(e), for individuals eligible |
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147 | 147 | | 5.22for drug coverage as defined in the Medicare Prescription Drug, Improvement, and |
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148 | 148 | | 5.23Modernization Act of 2003, Public Law 108-173, section 1860D-1(a)(3)(A). For these |
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149 | 149 | | 5.24individuals, medical assistance may cover drugs from the drug classes listed in United States |
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150 | 150 | | 5.25Code, title 42, section 1396r-8(d)(2), subject to this subdivision and subdivisions 13a to |
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151 | 151 | | 5.2613g, except that drugs listed in United States Code, title 42, section 1396r-8(d)(2)(E), shall |
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152 | 152 | | 5.27not be covered. |
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153 | 153 | | 5.28 (f) Medical assistance covers drugs acquired through the federal 340B Drug Pricing |
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154 | 154 | | 5.29Program and dispensed by 340B covered entities and ambulatory pharmacies under common |
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155 | 155 | | 5.30ownership of the 340B covered entity. Medical assistance does not cover drugs acquired |
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156 | 156 | | 5.31through the federal 340B Drug Pricing Program and dispensed by 340B contract pharmacies. |
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157 | 157 | | 5Sec. 3. |
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158 | 158 | | REVISOR RSI/HL 25-0242501/29/25 6.1 (g) Notwithstanding paragraph (a), medical assistance covers self-administered hormonal |
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159 | 159 | | 6.2contraceptives prescribed and dispensed by a licensed pharmacist in accordance with section |
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160 | 160 | | 6.3151.37, subdivision 14; nicotine replacement medications prescribed and dispensed by a |
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161 | 161 | | 6.4licensed pharmacist in accordance with section 151.37, subdivision 15; and opiate antagonists |
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162 | 162 | | 6.5used for the treatment of an acute opiate overdose prescribed and dispensed by a licensed |
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163 | 163 | | 6.6pharmacist in accordance with section 151.37, subdivision 16. |
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164 | 164 | | 6.7 (h) Medical assistance coverage for a prescription contraceptive must provide a 12-month |
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165 | 165 | | 6.8supply for any prescription contraceptive if a 12-month supply is prescribed by the |
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166 | 166 | | 6.9prescribing health care provider. The prescribing health care provider must determine the |
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167 | 167 | | 6.10appropriate duration for which to prescribe the prescription contraceptives, up to 12 months. |
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168 | 168 | | 6.11For purposes of this paragraph, "prescription contraceptive" means any drug or device that |
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169 | 169 | | 6.12requires a prescription and is approved by the Food and Drug Administration to prevent |
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170 | 170 | | 6.13pregnancy. Prescription contraceptive does not include an emergency contraceptive drug |
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171 | 171 | | 6.14approved to prevent pregnancy when administered after sexual contact. For purposes of this |
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172 | 172 | | 6.15paragraph, "health plan" has the meaning provided in section 62Q.01, subdivision 3. |
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173 | 173 | | 6.16 EFFECTIVE DATE.This section is effective January 1, 2026. |
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174 | 174 | | 6.17 Sec. 4. OUTREACH AND REPORTS. |
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175 | 175 | | 6.18 (a) The Department of Commerce must work with the Departments of Health and Human |
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176 | 176 | | 6.19Services to provide public information about over-the-counter contraception coverage. |
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177 | 177 | | 6.20 (b) The Department of Commerce must work with the Departments of Health and Human |
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178 | 178 | | 6.21Services and provide a report by March 31, 2027, and annually thereafter, to the standing |
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179 | 179 | | 6.22committees of the legislature with oversight of issues relating to commerce, health, and |
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180 | 180 | | 6.23human services. The report must include information and data regarding the use of coverage |
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181 | 181 | | 6.24and related costs to health plans and the state to provide over-the-counter contraceptives. |
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182 | 182 | | 6Sec. 4. |
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183 | 183 | | REVISOR RSI/HL 25-0242501/29/25 |
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