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5 | 5 | | 2023 -- H 5079 |
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6 | 6 | | ======== |
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7 | 7 | | LC000173 |
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8 | 8 | | ======== |
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9 | 9 | | S TATE OF RHODE IS LAND |
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10 | 10 | | IN GENERAL ASSEMBLY |
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11 | 11 | | JANUARY SESSION, A.D. 2023 |
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12 | 12 | | ____________ |
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13 | 13 | | |
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14 | 14 | | A N A C T |
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15 | 15 | | RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACEUTICAL COST |
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16 | 16 | | TRANSPARENCY |
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17 | 17 | | Introduced By: Representatives J Lombardi, Hull, Ajello, Kislak, Tanzi, and Felix |
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18 | 18 | | Date Introduced: January 12, 2023 |
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19 | 19 | | Referred To: House Corporations |
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20 | 20 | | |
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21 | 21 | | |
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22 | 22 | | It is enacted by the General Assembly as follows: |
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23 | 23 | | SECTION 1. Title 5 of the General Laws entitled "BUSINESSES AND PROFESSIONS" 1 |
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24 | 24 | | is hereby amended by adding thereto the following chapter: 2 |
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25 | 25 | | CHAPTER 19.3 3 |
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26 | 26 | | PHARMACEUTICAL COST TRANSPARENCY 4 |
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27 | 27 | | 5-19.3-1. Pharmaceutical cost transparency -- Findings. 5 |
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28 | 28 | | The general assembly hereby finds and declares as follows: 6 |
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29 | 29 | | (1) The costs of prescription drugs have been increasing with regularity; 7 |
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30 | 30 | | (2) Containing health care costs requires containing prescription drug costs; and 8 |
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31 | 31 | | (3) In order to contain prescription drug costs, it is essential to understand the drivers of 9 |
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32 | 32 | | those costs, as transparency is the first step toward cost containment. 10 |
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33 | 33 | | 5-19.3-2. Definitions. 11 |
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34 | 34 | | As used in this chapter: 12 |
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35 | 35 | | (1) "Board" means the state board of pharmacy created pursuant to § 5-19.1-3. 13 |
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36 | 36 | | (2) "Department" means the Rhode Island department of health. 14 |
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37 | 37 | | (3) "Manufacturer" means a person or entity licensed to manufacture legend drugs pursuant 15 |
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38 | 38 | | to § 5-19.1-12. 16 |
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39 | 39 | | (4) "Prescription drug" means a drug as defined in 21 U.S.C. § 321. 17 |
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40 | 40 | | 5-19.3-3. Identification of high cost prescription drugs. 18 |
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41 | 41 | | |
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42 | 42 | | |
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43 | 43 | | LC000173 - Page 2 of 6 |
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44 | 44 | | (a)(1) The state board of pharmacy, in collaboration with the department, shall identify 1 |
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45 | 45 | | annually up to fifteen (15) prescription drugs on which the state spends significant health care 2 |
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46 | 46 | | dollars and for which the wholesale acquisition cost has increased by fifty percent (50%) or more 3 |
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47 | 47 | | over the past five (5) years or by fifteen percent (15%) or more over the past twelve (12) months, 4 |
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48 | 48 | | creating a substantial public interest in understanding the development of the drugs' pricing. The 5 |
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49 | 49 | | drugs identified shall represent different drug classes. 6 |
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50 | 50 | | (2) The board shall provide to the office of the attorney general the list of prescription drugs 7 |
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51 | 51 | | developed pursuant to this subsection and the percentage of the wholesale acquisition cost increase 8 |
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52 | 52 | | for each drug and shall make the information available to the public on the board's website. 9 |
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53 | 53 | | (b)(1) For each prescription drug identified pursuant to subsection (a) of this section, the 10 |
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54 | 54 | | office of the attorney general shall require the drug's manufacturer to provide a justification for the 11 |
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55 | 55 | | increase in the wholesale acquisition cost of the drug in a format that the attorney general 12 |
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56 | 56 | | determines to be understandable and appropriate. The manufacturer shall submit to the office of 13 |
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57 | 57 | | the attorney general all relevant information and supporting documentation necessary to justify the 14 |
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58 | 58 | | manufacturer's wholesale acquisition cost increase, which may include: 15 |
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59 | 59 | | (i) All factors that have contributed to the wholesale acquisition cost increase; 16 |
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60 | 60 | | (ii) The percentage of the total wholesale acquisition cost increase attributable to each 17 |
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61 | 61 | | factor; and 18 |
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62 | 62 | | (iii) An explanation of the role of each factor in contributing to the wholesale acquisition 19 |
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63 | 63 | | cost increase. 20 |
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64 | 64 | | (2) Nothing in this section shall be construed to restrict the legal ability of a prescription 21 |
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65 | 65 | | drug manufacturer to change prices to the extent permitted under federal law. 22 |
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66 | 66 | | (c) The attorney general, in consultation with the department, shall provide a report to the 23 |
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67 | 67 | | general assembly on or before December 1 of each year based on the information received from 24 |
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68 | 68 | | manufacturers pursuant to this section. The attorney general shall also post the report on the office 25 |
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69 | 69 | | of the attorney general's website. 26 |
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70 | 70 | | (d) Information provided to the office of the attorney general pursuant to this section is 27 |
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71 | 71 | | exempt from public inspection and copying and is not a public record pursuant to chapter 2 of title 28 |
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72 | 72 | | 38 ("access to public records"), and shall not be released in a manner that allows for the 29 |
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73 | 73 | | identification of an individual drug or manufacturer or that is likely to compromise the financial, 30 |
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74 | 74 | | competitive, or proprietary nature of the information. 31 |
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75 | 75 | | 5-19.3-4. Injunctive relief. 32 |
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76 | 76 | | The attorney general may bring a civil action in the superior court for Providence county 33 |
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77 | 77 | | for injunctive relief, costs, and attorneys' fees, and to impose on a manufacturer that fails to provide 34 |
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78 | 78 | | |
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79 | 79 | | |
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80 | 80 | | LC000173 - Page 3 of 6 |
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81 | 81 | | the information required by § 5-19.3-3(b) a civil penalty of no more than ten thousand dollars 1 |
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82 | 82 | | ($10,000) per violation. Each unlawful failure to provide information shall constitute a separate 2 |
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83 | 83 | | violation. 3 |
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84 | 84 | | 5-19.3-5. Rulemaking. 4 |
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85 | 85 | | (a) On or before January l, 2024, the insurance commissioner shall adopt rules and 5 |
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86 | 86 | | regulations to require all health insurers that offer health benefit plans to Rhode Island residents 6 |
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87 | 87 | | through HealthSource RI or any successor health benefit exchange to provide information to 7 |
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88 | 88 | | enrollees, potential enrollees, and health care providers about the exchange plans' prescription drug 8 |
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89 | 89 | | formularies. 9 |
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90 | 90 | | (b) The rules shall ensure that: 10 |
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91 | 91 | | (1) The formulary is posted online in a standard format established by the insurance 11 |
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92 | 92 | | commissioner; 12 |
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93 | 93 | | (2) The formulary is updated frequently and is searchable by enrollees, potential enrollees, 13 |
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94 | 94 | | and health care providers; and 14 |
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95 | 95 | | (3) The formulary includes information about the prescription drugs covered, applicable 15 |
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96 | 96 | | cost-sharing amounts, drug tiers, prior authorization, step therapy, and utilization management 16 |
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97 | 97 | | requirements. 17 |
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98 | 98 | | 5-19.3-6. Dispensing fees. 18 |
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99 | 99 | | (a) The department shall use the same dispensing fee in its reimbursement formula for 19 |
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100 | 100 | | 340B prescription drugs as the department uses to pay for non-340B prescription drugs under the 20 |
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101 | 101 | | Medicaid program. 21 |
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102 | 102 | | (b) Notwithstanding the provisions of subsection (a) of this section, the department is 22 |
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103 | 103 | | authorized to modify the dispensing fee or reimbursement formula provided to federally qualified 23 |
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104 | 104 | | health centers and Title X family planning clinics for dispensing 340B prescription drugs to 24 |
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105 | 105 | | Medicaid beneficiaries. 25 |
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106 | 106 | | 5-19.3-7. Drug reimbursement - Reporting. 26 |
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107 | 107 | | (a) The department shall: 27 |
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108 | 108 | | (1) Determine the formula used by other states' Medicaid programs to reimburse covered 28 |
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109 | 109 | | entities that use 340B pricing for dispensing prescription drugs to Medicaid beneficiaries; 29 |
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110 | 110 | | (2) Evaluate the advantages and disadvantages of using the same dispensing fee in its 30 |
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111 | 111 | | reimbursement formula for 340B prescription drugs as the department uses to pay for non-340B 31 |
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112 | 112 | | prescription drugs under the Medicaid program; and 32 |
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113 | 113 | | (3) Identify the benefits, if any, of 340B drug pricing to consumers, other payers, and the 33 |
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114 | 114 | | overall health care system. 34 |
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115 | 115 | | |
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116 | 116 | | |
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117 | 117 | | LC000173 - Page 4 of 6 |
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118 | 118 | | (b) On or before March 15, 2024, the department shall report to the house of 1 |
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119 | 119 | | representatives, the senate, and the governor's office regarding its findings and recommendations, 2 |
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120 | 120 | | including recommended modifications to Rhode Island's 340B reimbursement formula, if any, and 3 |
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121 | 121 | | the financial implications of implementing any recommended modifications. 4 |
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122 | 122 | | 5-19.3-8. Out-of-pocket prescription drug limits – Advisory commission. 5 |
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123 | 123 | | (a) The Rhode Island department of health shall convene an advisory commission to 6 |
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124 | 124 | | develop options for all qualified health benefit plans to be offered on the Rhode Island health benefit 7 |
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125 | 125 | | exchange for the 2025 plan year, including: 8 |
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126 | 126 | | (1) One or more plans with a higher out-of-pocket limit on prescription drug coverage than 9 |
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127 | 127 | | the limit established pursuant to current law and regulations; and 10 |
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128 | 128 | | (2) Two (2) or more plans with an out-of-pocket limit at or below the limit established 11 |
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129 | 129 | | pursuant to current law and regulations. 12 |
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130 | 130 | | (b) The advisory commission shall include at least the following members: 13 |
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131 | 131 | | (1) A representative of the Rhode Island health benefits exchange, appointed by the 14 |
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132 | 132 | | governor; 15 |
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133 | 133 | | (2) A representative of each of the commercial health insurers offering plans on the Rhode 16 |
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134 | 134 | | Island health benefit exchange, appointed by each insurer; 17 |
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135 | 135 | | (3) The insurance commissioner, or designee; 18 |
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136 | 136 | | (4) A representative of the exchange advisory board established pursuant to § 42-157-7, 19 |
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137 | 137 | | appointed by the governor; 20 |
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138 | 138 | | (4) A representative of a Rhode Island AIDS services organization, appointed by the 21 |
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139 | 139 | | governor; 22 |
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140 | 140 | | (5) The director of the department of administration, or designee; 23 |
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141 | 141 | | (6) The director of the department of health, or designee; 24 |
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142 | 142 | | (7) A consumer nominated by a Rhode Island AIDS services organization and appointed 25 |
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143 | 143 | | by the governor; 26 |
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144 | 144 | | (8) A representative of the American Cancer Society appointed by the governor; and 27 |
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145 | 145 | | (9) A consumer nominated by the American Cancer Society and appointed by the governor. 28 |
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146 | 146 | | (c)(1) The advisory commission shall meet at least six (6) times prior to the department 29 |
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147 | 147 | | submitting plan designs to the state board of pharmacy for approval. 30 |
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148 | 148 | | (2) In developing the standard qualified health benefit plan designs for the 2025 plan year, 31 |
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149 | 149 | | the department shall present the recommendations of the advisory commission established pursuant 32 |
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150 | 150 | | to this section. 33 |
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151 | 151 | | 5-19.3-9. Reports. 34 |
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152 | 152 | | |
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153 | 153 | | |
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154 | 154 | | LC000173 - Page 5 of 6 |
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155 | 155 | | (a) On or before February 15, 2024, the department shall provide to the governor, the house 1 |
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156 | 156 | | of representatives, and the senate: 2 |
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157 | 157 | | (1) An overview of the cost-share increase trend for all qualified health benefit plans 3 |
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158 | 158 | | offered on the Rhode Island health benefit exchange for the 2018 through 2023 plan years that were 4 |
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159 | 159 | | subject to the out-of-pocket prescription drug limit established in state law or regulation; 5 |
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160 | 160 | | (2) Detailed information regarding lower cost-sharing amounts for selected services that 6 |
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161 | 161 | | will be available in all qualified health benefit plans in the 2024 plan year due to the flexibility to 7 |
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162 | 162 | | increase the out-of-pocket prescription drug limits established pursuant to this chapter; 8 |
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163 | 163 | | (3) A comparison of the bronze-level qualified health benefit plans offered in the 2024 plan 9 |
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164 | 164 | | year in which there will be flexibility in the out-of-pocket prescription drug limit established under 10 |
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165 | 165 | | state law and regulation; 11 |
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166 | 166 | | (4) Information about the process engaged in by the advisory commission established in 12 |
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167 | 167 | | this chapter and the information considered to determine modifications to the cost-sharing amounts 13 |
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168 | 168 | | in all qualified health benefit plans for the 2024 plan year, including prior year utilization trends, 14 |
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169 | 169 | | feedback from consumers and health insurers, health benefit exchange outreach and education 15 |
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170 | 170 | | efforts, and relevant national studies; 16 |
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171 | 171 | | (5) Cost-sharing information for standard qualified health benefit plans from states with 17 |
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172 | 172 | | federally-facilitated exchanges compared to those on the Rhode Island health benefit exchange; 18 |
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173 | 173 | | and 19 |
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174 | 174 | | (6) An overview of the outreach and education plan for enrollees in all qualified health 20 |
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175 | 175 | | benefit plans offered on the Rhode Island health benefit exchange. 21 |
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176 | 176 | | (b) On or before February l, 2025, the department shall report to the governor, the house 22 |
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177 | 177 | | of representatives, and the senate: 23 |
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178 | 178 | | (1) Enrollment trends in all qualified health benefit plans offered on the Rhode Island 24 |
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179 | 179 | | health benefit exchange; and 25 |
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180 | 180 | | (2) Recommendations from the advisory commission established pursuant to § 5-19.3-8 26 |
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181 | 181 | | regarding modification of out-of-pocket prescription drug cost limits. 27 |
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182 | 182 | | SECTION 2. This act shall take effect upon passage. 28 |
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183 | 183 | | ======== |
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184 | 184 | | LC000173 |
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185 | 185 | | ======== |
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186 | 186 | | |
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187 | 187 | | |
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188 | 188 | | LC000173 - Page 6 of 6 |
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189 | 189 | | EXPLANATION |
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190 | 190 | | BY THE LEGISLATIVE COUNCIL |
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191 | 191 | | OF |
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192 | 192 | | A N A C T |
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193 | 193 | | RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACEUTICAL COST |
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194 | 194 | | TRANSPARENCY |
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195 | 195 | | *** |
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196 | 196 | | This act would direct the state board of pharmacy, in collaboration with the department of 1 |
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197 | 197 | | health, to annually identify up to fifteen (15) prescription drugs on which the state spends 2 |
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198 | 198 | | significant health care dollars due to increases in costs. This list would be provided to the attorney 3 |
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199 | 199 | | general's office, and the attorney general's office would require the drug's manufacturers to submit 4 |
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200 | 200 | | relevant information and documentation to justify these cost increases. The act would also direct 5 |
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201 | 201 | | the department of health to use the same dispensing fee in its reimbursement formula for 340B 6 |
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202 | 202 | | prescription drugs as it uses to pay for non-340B prescription drugs under the Medicaid program, 7 |
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203 | 203 | | and to provide information to the general assembly and the governor about these programs. The act 8 |
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204 | 204 | | would also establish an advisory commission on out-of-pocket prescription drug costs who would 9 |
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205 | 205 | | study these costs and make reports and recommendations to the governor and the general assembly. 10 |
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206 | 206 | | This act would take effect upon passage. 11 |
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207 | 207 | | ======== |
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208 | 208 | | LC000173 |
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209 | 209 | | ======== |
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