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5 | 5 | | 2023 -- H 5078 |
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6 | 6 | | ======== |
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7 | 7 | | LC000180 |
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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 INSURANCE -- CONTROL OF HIGH PRESCRIPTION COSTS -- |
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16 | 16 | | REGULATION OF PHARMA CY BENEFIT MANAGERS |
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17 | 17 | | Introduced By: Representatives J Lombardi, Hull, and Kislak |
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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 27 of the General Laws entitled "INSURANCE" is hereby amended by 1 |
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24 | 24 | | adding thereto the following chapter: 2 |
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25 | 25 | | CHAPTER 20.12 3 |
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26 | 26 | | CONTROL OF HIGH PRESCRIPTION COSTS -- REGULATION OF PHARMACY BENEFIT 4 |
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27 | 27 | | MANAGERS 5 |
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28 | 28 | | 27-20.12-1. Legislative findings. 6 |
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29 | 29 | | The general assembly finds and declares: 7 |
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30 | 30 | | (1) About forty percent (40%) of Americans struggle to afford their regular prescription 8 |
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31 | 31 | | medicines, with one-third (1/3) saying they have skipped filling a prescription one or more times, 9 |
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32 | 32 | | because of the cost. 10 |
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33 | 33 | | (2) COVID-19 has exacerbated this problem by causing job and health insurance loss and 11 |
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34 | 34 | | delaying routine care. 12 |
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35 | 35 | | (3) Pharmacy benefit managers (PBMs) are employed by for-profit companies that manage 13 |
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36 | 36 | | prescription drug benefits for more than two hundred sixty-six million (266,000,000) Americans 14 |
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37 | 37 | | on behalf of private insurers, Medicare Part D drug plans, government employee plans, large 15 |
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38 | 38 | | employers, and Medicaid managed care organizations (MCOs). 16 |
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39 | 39 | | (4) PBMs began in the 1970s as small independent middlemen between insurers and 17 |
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40 | 40 | | pharmacies, taking a set fee for processing claims. 18 |
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41 | 41 | | |
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42 | 42 | | |
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43 | 43 | | LC000180 - Page 2 of 7 |
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44 | 44 | | (5) Today, three (3) PBMs control eighty percent (80%) of the market and are part of large 1 |
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45 | 45 | | vertically integrated conglomerates that include health insurance companies and pharmacies: 2 |
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46 | 46 | | (i) CVS Caremark – thirty-two percent (32%) market share – parent company: CVS 3 |
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47 | 47 | | (Aetna); 4 |
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48 | 48 | | (ii) Express Scripts – twenty-four percent (24%) market share – parent company: Cigna; 5 |
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49 | 49 | | and 6 |
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50 | 50 | | (iii) OptumRx – twenty-one percent (21%) market share – parent company: UnitedHealth. 7 |
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51 | 51 | | (6) Revenues of top PBM conglomerates exceed those of top pharmaceutical manufacturers 8 |
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52 | 52 | | and PBM conglomerates such as CVS, United Health Group and Cigna are ranked fourth, fifth and 9 |
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53 | 53 | | thirteenth, respectively, on the Fortune 500 list ranking largest corporations by revenue. 10 |
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54 | 54 | | (7) PBMs drive revenues for their parent companies, e.g., CVS Health’s Pharmacy Services 11 |
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55 | 55 | | (PBM) segment will make forty-six percent (46%) of three hundred twenty-four billion dollars 12 |
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56 | 56 | | ($324,000,000,000) in 2021 revenues for the company and remains key to its revenue growth. 13 |
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57 | 57 | | (8) PBMs harm consumers and taxpayers because: 14 |
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58 | 58 | | (i) PBMs have a conflict of interest and put drugs on formularies to get higher legal 15 |
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59 | 59 | | kickbacks ("rebates") from drug manufacturers rather than choose the most effective or affordable 16 |
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60 | 60 | | drugs for consumers. 17 |
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61 | 61 | | (ii) Drug manufacturers cover PBM rebates by raising list prices for drugs and rebates – 18 |
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62 | 62 | | adding an estimated thirty cents ($0.30) per dollar to the price consumers pay for prescriptions. 19 |
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63 | 63 | | (iii) Maximum allowable cost ("MAC") prices are the upper limits that a PBM will pay a 20 |
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64 | 64 | | pharmacy for generic drugs and brand name drugs that have generic versions available (multi-21 |
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65 | 65 | | source brands). PBMs use arbitrary and opaque MAC pricing to charge insurers (including state 22 |
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66 | 66 | | Medicaid) more than what they reimburse pharmacies and are allowed to pocket the difference 23 |
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67 | 67 | | ("the spread"). 24 |
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68 | 68 | | (9) PBM conglomerates own retail, mail order and specialty pharmacies and work against 25 |
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69 | 69 | | consumer interests by: 26 |
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70 | 70 | | (i) Setting low reimbursements for their competitors, causing local independent pharmacies 27 |
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71 | 71 | | to disappear; 28 |
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72 | 72 | | (ii) "Steering" customers to their affiliated mail order and specialty pharmacies, e.g., by 29 |
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73 | 73 | | requiring a higher copay if the patient obtains the drug from a non-affiliated pharmacy; and 30 |
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74 | 74 | | (iii) Not allowing pharmacists to discuss cheaper options ("gag orders"). 31 |
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75 | 75 | | (10) PBMs can make government oversight impossible by hiding profits in multiple ways, 32 |
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76 | 76 | | e.g., by: 33 |
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77 | 77 | | (i) Keeping their negotiated discounts and rebates as well as maximum allowable cost 34 |
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78 | 78 | | |
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79 | 79 | | |
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80 | 80 | | LC000180 - Page 3 of 7 |
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81 | 81 | | (MAC) lists confidential; 1 |
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82 | 82 | | (ii) Disguising profits, e.g., as "rebate management fees" and "savings"; and 2 |
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83 | 83 | | (iii) Controlling their own audits, e.g., by having the right to veto auditors, determine 3 |
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84 | 84 | | frequency of audits, and requiring auditors to sign "confidentiality agreements". 4 |
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85 | 85 | | (11) PBMs use "utilization management" that adversely affects clinical outcomes by 5 |
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86 | 86 | | making providers spend excessive time on administrative tasks, delaying and discouraging patient 6 |
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87 | 87 | | care, such as: 7 |
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88 | 88 | | (i) "Prior authorization," which requires patients to get third-party approval prior to getting 8 |
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89 | 89 | | the medicine prescribed by their health care provider; 9 |
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90 | 90 | | (ii) "Step therapy," also known as "fail-first," "sequencing," and "tiering," which requires 10 |
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91 | 91 | | patients to start with lower-priced medications before being approved for originally prescribed 11 |
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92 | 92 | | medications; and 12 |
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93 | 93 | | (iii) "Non-medical drug switching" which forces patients off their current therapies for no 13 |
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94 | 94 | | reason other than to save insurers money, including by increasing out-of-pocket costs, moving 14 |
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95 | 95 | | treatments to higher cost tiers, or terminating coverage of a particular drug. 15 |
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96 | 96 | | (12) PBMs can profit from a federal program ("Section 340B") meant to help low-income 16 |
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97 | 97 | | patients by engaging in "discriminatory reimbursement," e.g., offering 340B entities lower 17 |
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98 | 98 | | reimbursement rates than those offered to non-340B entities. 18 |
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99 | 99 | | (13) Multiple states besides Rhode Island are aggressively regulating PBMs, e.g., Ohio, 19 |
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100 | 100 | | Kentucky, New York, Pennsylvania, and Virginia. 20 |
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101 | 101 | | (i) Other states have taken actions including: 21 |
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102 | 102 | | (A) Imposing transparency reporting requirements; 22 |
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103 | 103 | | (B) Investigating PBMs; 23 |
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104 | 104 | | (C) Carving out PBMs from managing Medicaid pharmacy benefits; 24 |
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105 | 105 | | (D) Prohibiting spread pricing; 25 |
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106 | 106 | | (E) Restricting PBM rebates; 26 |
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107 | 107 | | (F) Prohibiting PBM "claw backs"; 27 |
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108 | 108 | | (G) Restricting Section 340B reimbursements; and 28 |
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109 | 109 | | (H) Limiting "utilization management." 29 |
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110 | 110 | | (14) A recent United States Supreme Court case, Rutledge v. PCMA, supports states taking 30 |
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111 | 111 | | more actions to regulate PBMs. 31 |
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112 | 112 | | (15) Rhode Island policymakers have essentially ignored PBMs and their effects on the 32 |
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113 | 113 | | cost of prescription drugs, see, e.g., office of health insurance commissioner and Rhode Island cost 33 |
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114 | 114 | | trends project health care cost analyses. 34 |
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115 | 115 | | |
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116 | 116 | | |
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117 | 117 | | LC000180 - Page 4 of 7 |
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118 | 118 | | (16) Five (5) year Rhode Island managed care organization (MCO) contracts with an 1 |
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119 | 119 | | estimated cost of one billion seven hundred million dollars ($1,700,000,000) per year were 2 |
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120 | 120 | | scheduled to expire and be renewed in April 2022, and were missing PBM oversight and 3 |
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121 | 121 | | restrictions, e.g., they did not require PBMs to identify their spread pricing profits and they did not 4 |
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122 | 122 | | make all statutory limits on prior authorizations also apply to Medicaid managed care PBMs. 5 |
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123 | 123 | | 27-20.12-2. Legislative intent. 6 |
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124 | 124 | | The intent of this legislation is to: 7 |
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125 | 125 | | (1) Ensure PBMs provide sufficient information to the state to allow accurate analyses of 8 |
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126 | 126 | | PBM costs and benefits for Rhode Island consumers and taxpayers. 9 |
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127 | 127 | | (2) Restrict PBM practices that lead to overcharging, including, "spread pricing," "claw 10 |
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128 | 128 | | backs," "pharmacy steering," discriminatory reimbursements, manufacturer rebates, and Section 11 |
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129 | 129 | | 340B discriminatory practices. 12 |
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130 | 130 | | (3) Restrict PBM and affiliated companies from imposing harmful utilization management 13 |
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131 | 131 | | practices on patients including, prior authorization, step therapy and non-medical drug switching. 14 |
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132 | 132 | | (4) Establish enforcement procedures and penalties to ensure consumer and taxpayer 15 |
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133 | 133 | | protection and PBM compliance with this chapter. 16 |
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134 | 134 | | 27-20.12-3. Definitions. 17 |
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135 | 135 | | As used in this chapter: 18 |
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136 | 136 | | (1) "Other manufacturer revenue(s)" means, without limitation, compensation or 19 |
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137 | 137 | | remuneration received or recovered, directly or indirectly, from a pharmaceutical manufacturer for 20 |
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138 | 138 | | administrative, educational, research, clinical program, or other services, product selection 21 |
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139 | 139 | | switching incentives, charge-back fees, market share incentives, drug pull-through programs, or 22 |
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140 | 140 | | any payment amounts related to the number of covered lives, formularies, or the PBM’s 23 |
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141 | 141 | | relationship with the payer. 24 |
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142 | 142 | | (2) "Rebate(s)" means all price concessions paid by a manufacturer or any other third party 25 |
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143 | 143 | | to PBMs including rebates, discounts, credits, fees, manufacturer administrative fees, or other 26 |
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144 | 144 | | payments that are based on actual or estimated utilization of a covered drug or price concessions 27 |
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145 | 145 | | based on the effectiveness of a covered drug. 28 |
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146 | 146 | | 27-20.12-4. Implementation. 29 |
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147 | 147 | | (a) PBMs shall provide state authorities and the general public information on a quarterly 30 |
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148 | 148 | | or more frequent basis that permits an accurate determination of the costs and benefits of PBMs for 31 |
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149 | 149 | | Rhode Island taxpayers and consumers. 32 |
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150 | 150 | | (b) The executive office of health and human services (EOHHS) shall carve out PBMs 33 |
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151 | 151 | | from Medicaid Managed Care Organization (MCO) contracts set to renew after July 1, 2023. 34 |
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152 | 152 | | |
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153 | 153 | | |
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154 | 154 | | LC000180 - Page 5 of 7 |
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155 | 155 | | (c) PBMs shall cease activities that result in "spread pricing" profits, including creating 1 |
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156 | 156 | | multiple maximum acquisition cost (MAC) lists that list higher prices for insurer to PBM 2 |
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157 | 157 | | reimbursements and lower prices for PBM to pharmacy reimbursements for the same drug. 3 |
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158 | 158 | | (d) PBMs shall implement administrative-fee only compensation, i.e., a set per-member-4 |
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159 | 159 | | per-month (PMPM) fee that is the sole compensation for services performed. 5 |
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160 | 160 | | (e) PBMs shall implement pharmacy pass-through pricing. For covered claims paid by 6 |
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161 | 161 | | PBMs, the payers shall reimburse the PBM an amount equal to the actual amount the PBM pays to 7 |
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162 | 162 | | the dispensing pharmacy, including any contracted dispensing fee. In no event shall payers owe the 8 |
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163 | 163 | | PBM more than the amount the PBM paid to the dispensing pharmacy, including any contracted 9 |
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164 | 164 | | dispensing fee. 10 |
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165 | 165 | | (f) PBMs shall implement one hundred percent (100%) pass-through of manufacturer-11 |
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166 | 166 | | derived revenues. 12 |
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167 | 167 | | (g) PBMs shall pay or credit payers one hundred percent (100%) of all manufacturer-13 |
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168 | 168 | | derived revenue PBMs receive, including rebates and other manufacturer revenues. 14 |
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169 | 169 | | (h) PBMs shall not charge payers any management or administrative fees associated with 15 |
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170 | 170 | | obtaining, collecting, or negotiating any manufacturer-derived revenue. 16 |
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171 | 171 | | 27-20.12-5. Requirements for pharmacy benefits managers. 17 |
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172 | 172 | | PBMs shall: 18 |
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173 | 173 | | (1) Cease taking money that consumers paid pharmacies as co-pays in excess of what 19 |
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174 | 174 | | pharmacies paid to acquire a drug (i.e., taking "claw backs") and any such funds shall be returned 20 |
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175 | 175 | | to consumers; 21 |
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176 | 176 | | (2) Cease reimbursing affiliated pharmacies more than non-affiliated pharmacies for the 22 |
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177 | 177 | | same drugs; 23 |
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178 | 178 | | (3) Cease "pharmacy steering," i.e., steering consumers to affiliated pharmacies (including 24 |
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179 | 179 | | mail order and specialty pharmacies), e.g., by requiring a higher copay if the patient obtains the 25 |
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180 | 180 | | drug from a non-affiliated pharmacy; 26 |
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181 | 181 | | (4) Prioritize benefits to consumers and not PBM or affiliated company profits in 27 |
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182 | 182 | | determining placement of drugs on formularies; 28 |
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183 | 183 | | (5) Cease profiting from a federal program ("Section 340B") meant to help low-income 29 |
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184 | 184 | | patients by engaging in "discriminatory reimbursement," e.g., offering 340B entities lower 30 |
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185 | 185 | | reimbursement rates than those offered to non-340B entities; and 31 |
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186 | 186 | | (6) Cease "utilization management" strategies that delay and discourage patient care, and 32 |
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187 | 187 | | adversely affect clinical outcomes, including, prior authorizations, step therapy and non-medical 33 |
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188 | 188 | | drug switching. 34 |
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189 | 189 | | |
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190 | 190 | | |
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191 | 191 | | LC000180 - Page 6 of 7 |
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192 | 192 | | 27-20.12-6. Compliance -- Rules and regulations. 1 |
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193 | 193 | | (a) The executive office of health and human services (EOHHS), the department of 2 |
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194 | 194 | | business regulation (DBR), and the office of health insurance commissioner (OHIC), shall ensure 3 |
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195 | 195 | | that PBMs comply with the provisions of this chapter by the promulgation of any rules and 4 |
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196 | 196 | | regulations they deem necessary. 5 |
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197 | 197 | | (b) The office of the auditor general shall hire and supervise financial consultants with 6 |
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198 | 198 | | expertise about PBMs to conduct or oversee audits that determine whether PBM costs to the state 7 |
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199 | 199 | | are excessive and whether PBMs are in compliance with the provisions set forth in this chapter. 8 |
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200 | 200 | | (c) The attorney general is hereby authorized to undertake appropriate civil and criminal 9 |
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201 | 201 | | investigations of and actions against PBMs and affiliates to enforce the provisions of this chapter. 10 |
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202 | 202 | | SECTION 2. This act shall take effect upon passage. 11 |
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203 | 203 | | ======== |
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204 | 204 | | LC000180 |
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206 | 206 | | |
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207 | 207 | | |
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208 | 208 | | LC000180 - Page 7 of 7 |
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209 | 209 | | EXPLANATION |
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210 | 210 | | BY THE LEGISLATIVE COUNCIL |
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211 | 211 | | OF |
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212 | 212 | | A N A C T |
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213 | 213 | | RELATING TO INSURANCE -- CONTROL OF HIGH PRESCRIPTION COSTS -- |
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214 | 214 | | REGULATION OF PHARMA CY BENEFIT MANAGERS |
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215 | 215 | | *** |
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216 | 216 | | This act would regulate pharmacy benefit managers' (PBMs) policies and practices through 1 |
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217 | 217 | | rules and regulations promulgated by the executive office of health and human services (EOHHS), 2 |
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218 | 218 | | the department of business regulation (DBR), and the office of health insurance commissioner 3 |
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219 | 219 | | (OHIC), relating to accurate costs and pricing reporting, restricting discriminatory practices and 4 |
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220 | 220 | | establishing consumer protections with enforcement for violations by the office of the attorney 5 |
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221 | 221 | | general. 6 |
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222 | 222 | | This act would take effect upon passage. 7 |
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224 | 224 | | LC000180 |
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