1 | 1 | | 1.1 A bill for an act |
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2 | 2 | | 1.2 relating to health insurance; establishing supply requirements for prescription |
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3 | 3 | | 1.3 contraceptives; requiring health plans to cover contraceptive methods, sterilization, |
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4 | 4 | | 1.4 and related medical services, patient education, and counseling; establishing |
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5 | 5 | | 1.5 accommodations for eligible organizations; amending Minnesota Statutes 2022, |
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6 | 6 | | 1.6 section 256B.0625, subdivision 13; proposing coding for new law in Minnesota |
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7 | 7 | | 1.7 Statutes, chapter 62Q. |
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8 | 8 | | 1.8BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: |
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9 | 9 | | 1.9 Section 1. [62Q.522] COVERAGE OF CONTRACEPTIVE METHODS AND |
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10 | 10 | | 1.10SERVICES. |
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11 | 11 | | 1.11 Subdivision 1.Definitions.(a) The definitions in this subdivision apply to this section. |
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12 | 12 | | 1.12 (b) "Closely held for-profit entity" means an entity that: |
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13 | 13 | | 1.13 (1) is not a nonprofit entity; |
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14 | 14 | | 1.14 (2) has more than 50 percent of the value of its ownership interest owned directly or |
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15 | 15 | | 1.15indirectly by five or fewer individuals, or has an ownership structure that is substantially |
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16 | 16 | | 1.16similar; and |
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17 | 17 | | 1.17 (3) has no publicly traded ownership interest, having any class of common equity |
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18 | 18 | | 1.18securities required to be registered under United States Code, title 15, section 781. |
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19 | 19 | | 1.19For purposes of this paragraph: |
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20 | 20 | | 1.20 (i) ownership interests owned by a corporation, partnership, estate, or trust are considered |
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21 | 21 | | 1.21owned proportionately by that entity's shareholders, partners, or beneficiaries; |
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22 | 22 | | 1Section 1. |
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23 | 23 | | 23-01099 as introduced01/17/23 REVISOR SGS/LN |
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24 | 24 | | SENATE |
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25 | 25 | | STATE OF MINNESOTA |
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26 | 26 | | S.F. No. 831NINETY-THIRD SESSION |
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27 | 27 | | (SENATE AUTHORS: PAPPAS) |
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28 | 28 | | OFFICIAL STATUSD-PGDATE |
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29 | 29 | | Introduction and first reading01/26/2023 |
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30 | 30 | | Referred to Health and Human Services 2.1 (ii) ownership interests owned by a nonprofit entity are considered owned by a single |
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31 | 31 | | 2.2owner; |
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32 | 32 | | 2.3 (iii) ownership interests owned by an individual are considered owned, directly or |
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33 | 33 | | 2.4indirectly, by or for the individual's family. For purposes of this item, "family" means |
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34 | 34 | | 2.5brothers and sisters, including half-brothers and half-sisters, a spouse, ancestors, and lineal |
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35 | 35 | | 2.6descendants; and |
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36 | 36 | | 2.7 (iv) if an individual or entity holds an option to purchase an ownership interest, the |
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37 | 37 | | 2.8individual or entity is considered to be the owner of those ownership interests. |
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38 | 38 | | 2.9 (c) "Contraceptive method" means a drug, device, or other product approved by the Food |
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39 | 39 | | 2.10and Drug Administration to prevent unintended pregnancy. |
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40 | 40 | | 2.11 (d) "Contraceptive service" means consultation, examination, procedures, and medical |
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41 | 41 | | 2.12services related to the prevention of unintended pregnancy. This includes but is not limited |
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42 | 42 | | 2.13to voluntary sterilization procedures, patient education, counseling on contraceptives, and |
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43 | 43 | | 2.14follow-up services related to contraceptive methods or services, management of side effects, |
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44 | 44 | | 2.15counseling for continued adherence, and device insertion or removal. |
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45 | 45 | | 2.16 (e) "Eligible organization" means an organization that opposes providing coverage for |
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46 | 46 | | 2.17some or all contraceptive methods or services on account of religious objections and that |
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47 | 47 | | 2.18is: |
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48 | 48 | | 2.19 (1) organized as a nonprofit entity and holds itself as a religious organization; or |
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49 | 49 | | 2.20 (2) organized and operates as a closely held for-profit entity, and the organization's |
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50 | 50 | | 2.21highest governing body has adopted, under the organization's applicable rules of governance |
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51 | 51 | | 2.22and consistent with state law, a resolution or similar action establishing that it objects to |
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52 | 52 | | 2.23covering some or all contraceptive methods or services on account of the owners' sincerely |
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53 | 53 | | 2.24held religious beliefs. |
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54 | 54 | | 2.25 (f) "Medical necessity" includes but is not limited to considerations such as severity of |
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55 | 55 | | 2.26side effects, difference in permanence and reversability of a contraceptive method or service, |
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56 | 56 | | 2.27and ability to adhere to the appropriate use of the contraceptive method or service, as |
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57 | 57 | | 2.28determined by the attending provider. |
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58 | 58 | | 2.29 (g) "Religious organization" means an organization that is organized and operates as a |
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59 | 59 | | 2.30nonprofit entity and meets the requirements of section 6033(a)(3)(A)(i) or (iii) of the Internal |
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60 | 60 | | 2.31Revenue Code of 1986, as amended. |
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61 | 61 | | 2Section 1. |
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62 | 62 | | 23-01099 as introduced01/17/23 REVISOR SGS/LN 3.1 (h) "Therapeutic equivalent version" means a drug, device, or product that can be expected |
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63 | 63 | | 3.2to have the same clinical effect and safety profile when administered to a patient under the |
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64 | 64 | | 3.3conditions specified in the labeling, and that: |
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65 | 65 | | 3.4 (1) is approved as safe and effective; |
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66 | 66 | | 3.5 (2) is a pharmaceutical equivalent, (i) containing identical amounts of the same active |
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67 | 67 | | 3.6drug ingredient in the same dosage form and route of administration, and (ii) meeting |
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68 | 68 | | 3.7compendial or other applicable standards of strength, quality, purity, and identity; |
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69 | 69 | | 3.8 (3) is bioequivalent in that: |
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70 | 70 | | 3.9 (i) the drug, device, or product does not present a known or potential bioequivalence |
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71 | 71 | | 3.10problem and meets an acceptable in vitro standard; or |
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72 | 72 | | 3.11 (ii) if the drug, device, or product does present a known or potential bioequivalence |
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73 | 73 | | 3.12problem, it is shown to meet an appropriate bioequivalence standard; |
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74 | 74 | | 3.13 (4) is adequately labeled; and |
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75 | 75 | | 3.14 (5) is manufactured in compliance with current manufacturing practice regulations. |
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76 | 76 | | 3.15 Subd. 2.Required coverage; cost sharing prohibited.(a) A health plan must provide |
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77 | 77 | | 3.16coverage for contraceptive methods and services. |
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78 | 78 | | 3.17 (b) A health plan company must not impose cost-sharing requirements, including co-pays, |
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79 | 79 | | 3.18deductibles, or co-insurance, for contraceptive methods or services. |
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80 | 80 | | 3.19 (c) Notwithstanding paragraph (b), a health plan that is a high-deductible health plan in |
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81 | 81 | | 3.20conjunction with a health savings account must include cost-sharing for contraceptive |
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82 | 82 | | 3.21methods and services at the minimum level necessary to preserve the enrollee's ability to |
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83 | 83 | | 3.22make tax exempt contributions and withdrawals from the health savings account, as provided |
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84 | 84 | | 3.23by section 223 of the Internal Revenue Code of 1986, as amended. |
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85 | 85 | | 3.24 (d) A health plan company must not impose any referral requirements, restrictions, or |
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86 | 86 | | 3.25delays for contraceptive methods or services. |
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87 | 87 | | 3.26 (e) A health plan must include at least one of each type of Food and Drug Administration |
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88 | 88 | | 3.27approved contraceptive method in its formulary. If more than one therapeutic equivalent |
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89 | 89 | | 3.28version of a contraceptive method is approved, a health plan must include at least one |
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90 | 90 | | 3.29therapeutic equivalent version in its formulary, but is not required to include all therapeutic |
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91 | 91 | | 3.30equivalent versions. |
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92 | 92 | | 3.31 (f) For each health plan, a health plan company must list the contraceptive methods and |
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93 | 93 | | 3.32services that are covered without cost-sharing in a manner that is easily accessible to |
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94 | 94 | | 3Section 1. |
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95 | 95 | | 23-01099 as introduced01/17/23 REVISOR SGS/LN 4.1enrollees, health care providers, and representatives of health care providers. The list for |
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96 | 96 | | 4.2each health plan must be promptly updated to reflect changes to the coverage. |
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97 | 97 | | 4.3 (g) If an enrollee's attending provider recommends a particular contraceptive method or |
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98 | 98 | | 4.4service based on a determination of medical necessity for that enrollee, the health plan must |
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99 | 99 | | 4.5cover that contraceptive method or service without cost-sharing. The health plan company |
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100 | 100 | | 4.6issuing the health plan must defer to the attending provider's determination that the particular |
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101 | 101 | | 4.7contraceptive method or service is medically necessary for the enrollee. |
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102 | 102 | | 4.8 Subd. 3.Religious employers; exempt(a) A religious employer is not required to cover |
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103 | 103 | | 4.9contraceptive methods or services if the employer has religious objections to the coverage. |
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104 | 104 | | 4.10A religious employer that chooses to not provide coverage for contraceptive methods and |
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105 | 105 | | 4.11services must notify employees as part of the hiring process and to all employees at least |
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106 | 106 | | 4.1230 days before: |
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107 | 107 | | 4.13 (1) an employee enrolls in the health plan; or |
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108 | 108 | | 4.14 (2) the effective date of the health plan, whichever occurs first. |
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109 | 109 | | 4.15 (b) If the religious employer provides coverage for some contraceptive methods or |
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110 | 110 | | 4.16services, the notice must provide a list of the contraceptive methods or services the employer |
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111 | 111 | | 4.17refuses to cover. |
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112 | 112 | | 4.18 Subd. 4.Accommodation for eligible organizations.(a) A health plan established or |
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113 | 113 | | 4.19maintained by an eligible organization complies with the requirements of subdivision 2 to |
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114 | 114 | | 4.20provide coverage of contraceptive methods and services if the eligible organization provides |
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115 | 115 | | 4.21notice to any health plan company the eligible organization contracts with that it is an eligible |
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116 | 116 | | 4.22organization and that the eligible organization has a religious objection to coverage for all |
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117 | 117 | | 4.23or a subset of contraceptive methods or services. |
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118 | 118 | | 4.24 (b) The notice from an eligible organization to a health plan company under paragraph |
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119 | 119 | | 4.25(a) must include (1) the name of the eligible organization, (2) a statement that it objects to |
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120 | 120 | | 4.26coverage for some or all of contraceptive methods or services, including a list of the |
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121 | 121 | | 4.27contraceptive methods or services the eligible organization objects to, if applicable, and (3) |
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122 | 122 | | 4.28the health plan name. The notice must be executed by a person authorized to provide notice |
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123 | 123 | | 4.29on behalf of the eligible organization. |
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124 | 124 | | 4.30 (c) An eligible organization must provide a copy of the notice under paragraph (b) to |
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125 | 125 | | 4.31prospective employees as part of the hiring process and to all employees at least 30 days |
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126 | 126 | | 4.32before: |
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127 | 127 | | 4.33 (1) an employee enrolls in the health plan; or |
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128 | 128 | | 4Section 1. |
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129 | 129 | | 23-01099 as introduced01/17/23 REVISOR SGS/LN 5.1 (2) the effective date of the health plan, whichever occurs first. |
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130 | 130 | | 5.2 (d) A health plan company that receives a copy of the notice under paragraph (a) with |
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131 | 131 | | 5.3respect to a health plan established or maintained by an eligible organization must: |
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132 | 132 | | 5.4 (1) expressly exclude coverage for some or all contraceptive methods or services from |
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133 | 133 | | 5.5the health plan; and |
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134 | 134 | | 5.6 (2) provide separate payments for any contraceptive methods or services required to be |
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135 | 135 | | 5.7covered under subdivision 2 for enrollees as long as the enrollee remains enrolled in the |
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136 | 136 | | 5.8health plan. |
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137 | 137 | | 5.9 (e) The health plan company must not impose any cost-sharing requirements, including |
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138 | 138 | | 5.10co-pays, deductibles, or co-insurance, or directly or indirectly impose any premium, fee, or |
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139 | 139 | | 5.11other charge for contraceptive services or methods on the eligible organization, health plan, |
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140 | 140 | | 5.12or enrollee. |
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141 | 141 | | 5.13 (f) On January 1, 2025, and every year thereafter a health plan company must notify the |
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142 | 142 | | 5.14commissioner, in a manner to be determined by the commissioner, regarding the number |
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143 | 143 | | 5.15of eligible organizations granted an accommodation under this subdivision. |
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144 | 144 | | 5.16 EFFECTIVE DATE.This section is effective January 1, 2024, and applies to coverage |
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145 | 145 | | 5.17offered, sold, issued, or renewed on or after that date. |
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146 | 146 | | 5.18 Sec. 2. [62Q.523] COVERAGE FOR PRESCRIPTION CONTRACEPTIVES; |
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147 | 147 | | 5.19SUPPLY REQUIREMENTS. |
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148 | 148 | | 5.20 Subdivision 1.Scope of coverage.Except as otherwise provided in section 62Q.522, |
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149 | 149 | | 5.21subdivision 3, all health plans that provide prescription coverage must comply with the |
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150 | 150 | | 5.22requirements of this section. |
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151 | 151 | | 5.23 Subd. 2.Definition.For purposes of this section, "prescription contraceptive" means |
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152 | 152 | | 5.24any drug or device that requires a prescription and is approved by the Food and Drug |
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153 | 153 | | 5.25Administration to prevent pregnancy. Prescription contraceptive does not include an |
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154 | 154 | | 5.26emergency contraceptive drug that prevents pregnancy when administered after sexual |
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155 | 155 | | 5.27contact. |
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156 | 156 | | 5.28 Subd. 3.Required coverage.(a) Health plan coverage for a prescription contraceptive |
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157 | 157 | | 5.29must provide a 12-month supply for any prescription contraceptive, regardless of whether |
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158 | 158 | | 5.30the enrollee was covered by the health plan at the time of the first dispensing. |
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159 | 159 | | 5.31 (b) The prescribing health care provider must determine the appropriate number of |
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160 | 160 | | 5.32months to prescribe the prescription contraceptives for, up to 12 months. |
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161 | 161 | | 5Sec. 2. |
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162 | 162 | | 23-01099 as introduced01/17/23 REVISOR SGS/LN 6.1 EFFECTIVE DATE.This section is effective January 1, 2024, and applies to coverage |
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163 | 163 | | 6.2offered, sold, issued, or renewed on or after that date. |
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164 | 164 | | 6.3 Sec. 3. Minnesota Statutes 2022, section 256B.0625, subdivision 13, is amended to read: |
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165 | 165 | | 6.4 Subd. 13.Drugs.(a) Medical assistance covers drugs, except for fertility drugs when |
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166 | 166 | | 6.5specifically used to enhance fertility, if prescribed by a licensed practitioner and dispensed |
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167 | 167 | | 6.6by a licensed pharmacist, by a physician enrolled in the medical assistance program as a |
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168 | 168 | | 6.7dispensing physician, or by a physician, a physician assistant, or an advanced practice |
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169 | 169 | | 6.8registered nurse employed by or under contract with a community health board as defined |
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170 | 170 | | 6.9in section 145A.02, subdivision 5, for the purposes of communicable disease control. |
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171 | 171 | | 6.10 (b) The dispensed quantity of a prescription drug must not exceed a 34-day supply, |
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172 | 172 | | 6.11unless authorized by the commissioner or the drug appears on the 90-day supply list published |
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173 | 173 | | 6.12by the commissioner. The 90-day supply list shall be published by the commissioner on the |
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174 | 174 | | 6.13department's website. The commissioner may add to, delete from, and otherwise modify |
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175 | 175 | | 6.14the 90-day supply list after providing public notice and the opportunity for a 15-day public |
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176 | 176 | | 6.15comment period. The 90-day supply list may include cost-effective generic drugs and shall |
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177 | 177 | | 6.16not include controlled substances as provided in paragraph (h). |
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178 | 178 | | 6.17 (c) For the purpose of this subdivision and subdivision 13d, an "active pharmaceutical |
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179 | 179 | | 6.18ingredient" is defined as a substance that is represented for use in a drug and when used in |
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180 | 180 | | 6.19the manufacturing, processing, or packaging of a drug becomes an active ingredient of the |
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181 | 181 | | 6.20drug product. An "excipient" is defined as an inert substance used as a diluent or vehicle |
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182 | 182 | | 6.21for a drug. The commissioner shall establish a list of active pharmaceutical ingredients and |
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183 | 183 | | 6.22excipients which are included in the medical assistance formulary. Medical assistance covers |
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184 | 184 | | 6.23selected active pharmaceutical ingredients and excipients used in compounded prescriptions |
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185 | 185 | | 6.24when the compounded combination is specifically approved by the commissioner or when |
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186 | 186 | | 6.25a commercially available product: |
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187 | 187 | | 6.26 (1) is not a therapeutic option for the patient; |
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188 | 188 | | 6.27 (2) does not exist in the same combination of active ingredients in the same strengths |
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189 | 189 | | 6.28as the compounded prescription; and |
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190 | 190 | | 6.29 (3) cannot be used in place of the active pharmaceutical ingredient in the compounded |
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191 | 191 | | 6.30prescription. |
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192 | 192 | | 6.31 (d) Medical assistance covers the following over-the-counter drugs when prescribed by |
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193 | 193 | | 6.32a licensed practitioner or by a licensed pharmacist who meets standards established by the |
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194 | 194 | | 6.33commissioner, in consultation with the board of pharmacy: antacids, acetaminophen, family |
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195 | 195 | | 6Sec. 3. |
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196 | 196 | | 23-01099 as introduced01/17/23 REVISOR SGS/LN 7.1planning products, aspirin, insulin, products for the treatment of lice, vitamins for adults |
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197 | 197 | | 7.2with documented vitamin deficiencies, vitamins for children under the age of seven and |
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198 | 198 | | 7.3pregnant or nursing women, and any other over-the-counter drug identified by the |
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199 | 199 | | 7.4commissioner, in consultation with the Formulary Committee, as necessary, appropriate, |
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200 | 200 | | 7.5and cost-effective for the treatment of certain specified chronic diseases, conditions, or |
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201 | 201 | | 7.6disorders, and this determination shall not be subject to the requirements of chapter 14. A |
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202 | 202 | | 7.7pharmacist may prescribe over-the-counter medications as provided under this paragraph |
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203 | 203 | | 7.8for purposes of receiving reimbursement under Medicaid. When prescribing over-the-counter |
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204 | 204 | | 7.9drugs under this paragraph, licensed pharmacists must consult with the recipient to determine |
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205 | 205 | | 7.10necessity, provide drug counseling, review drug therapy for potential adverse interactions, |
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206 | 206 | | 7.11and make referrals as needed to other health care professionals. |
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207 | 207 | | 7.12 (e) Effective January 1, 2006, medical assistance shall not cover drugs that are coverable |
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208 | 208 | | 7.13under Medicare Part D as defined in the Medicare Prescription Drug, Improvement, and |
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209 | 209 | | 7.14Modernization Act of 2003, Public Law 108-173, section 1860D-2(e), for individuals eligible |
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210 | 210 | | 7.15for drug coverage as defined in the Medicare Prescription Drug, Improvement, and |
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211 | 211 | | 7.16Modernization Act of 2003, Public Law 108-173, section 1860D-1(a)(3)(A). For these |
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212 | 212 | | 7.17individuals, medical assistance may cover drugs from the drug classes listed in United States |
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213 | 213 | | 7.18Code, title 42, section 1396r-8(d)(2), subject to this subdivision and subdivisions 13a to |
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214 | 214 | | 7.1913g, except that drugs listed in United States Code, title 42, section 1396r-8(d)(2)(E), shall |
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215 | 215 | | 7.20not be covered. |
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216 | 216 | | 7.21 (f) Medical assistance covers drugs acquired through the federal 340B Drug Pricing |
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217 | 217 | | 7.22Program and dispensed by 340B covered entities and ambulatory pharmacies under common |
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218 | 218 | | 7.23ownership of the 340B covered entity. Medical assistance does not cover drugs acquired |
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219 | 219 | | 7.24through the federal 340B Drug Pricing Program and dispensed by 340B contract pharmacies. |
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220 | 220 | | 7.25 (g) Notwithstanding paragraph (a), medical assistance covers self-administered hormonal |
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221 | 221 | | 7.26contraceptives prescribed and dispensed by a licensed pharmacist in accordance with section |
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222 | 222 | | 7.27151.37, subdivision 14; nicotine replacement medications prescribed and dispensed by a |
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223 | 223 | | 7.28licensed pharmacist in accordance with section 151.37, subdivision 15; and opiate antagonists |
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224 | 224 | | 7.29used for the treatment of an acute opiate overdose prescribed and dispensed by a licensed |
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225 | 225 | | 7.30pharmacist in accordance with section 151.37, subdivision 16. |
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226 | 226 | | 7.31 (h) Medical assistance coverage for a prescription contraceptive must provide a 12-month |
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227 | 227 | | 7.32supply for any prescription contraceptive, regardless of whether the enrollee was covered |
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228 | 228 | | 7.33by medical assistance or the health plan at the time of the first dispensing. The prescribing |
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229 | 229 | | 7.34health care provider must determine the appropriate number of months to prescribe the |
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230 | 230 | | 7.35prescription contraceptives for, up to 12 months. |
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231 | 231 | | 7Sec. 3. |
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232 | 232 | | 23-01099 as introduced01/17/23 REVISOR SGS/LN 8.1For purposes of this paragraph, "prescription contraceptive" means any drug or device that |
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233 | 233 | | 8.2requires a prescription and is approved by the Food and Drug Administration to prevent |
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234 | 234 | | 8.3pregnancy. Prescription contraceptive does not include an emergency contraceptive drug |
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235 | 235 | | 8.4approved to prevent pregnancy when administered after sexual contact. For purposes of this |
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236 | 236 | | 8.5paragraph, "health plan" has the meaning provided in section 62Q.01, subdivision 3. |
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237 | 237 | | 8.6 EFFECTIVE DATE.This section applies to medical assistance and MinnesotaCare |
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238 | 238 | | 8.7coverage effective January 1, 2024. |
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239 | 239 | | 8Sec. 3. |
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240 | 240 | | 23-01099 as introduced01/17/23 REVISOR SGS/LN |
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