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2 | 2 | | HOUSE DOCKET, NO. 2123 FILED ON: 1/15/2025 |
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3 | 3 | | HOUSE . . . . . . . . . . . . . . . No. 1082 |
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4 | 4 | | The Commonwealth of Massachusetts |
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5 | 5 | | _________________ |
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6 | 6 | | PRESENTED BY: |
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7 | 7 | | Bruce J. Ayers |
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8 | 8 | | _________________ |
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9 | 9 | | To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General |
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10 | 10 | | Court assembled: |
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11 | 11 | | The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill: |
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12 | 12 | | An Act to enact the pharmacy benefit manager compensation reform. |
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13 | 13 | | _______________ |
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14 | 14 | | PETITION OF: |
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15 | 15 | | NAME:DISTRICT/ADDRESS :DATE ADDED:Bruce J. Ayers1st Norfolk1/15/2025 1 of 9 |
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16 | 16 | | HOUSE DOCKET, NO. 2123 FILED ON: 1/15/2025 |
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17 | 17 | | HOUSE . . . . . . . . . . . . . . . No. 1082 |
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18 | 18 | | By Representative Ayers of Quincy, a petition (accompanied by bill, House, No. 1082) of Bruce |
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19 | 19 | | J. Ayers relative to pharmacy benefit manager insurance compensation reform. Financial |
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20 | 20 | | Services. |
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21 | 21 | | [SIMILAR MATTER FILED IN PREVIOUS SESSION |
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22 | 22 | | SEE HOUSE, NO. 934 OF 2023-2024.] |
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23 | 23 | | The Commonwealth of Massachusetts |
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24 | 24 | | _______________ |
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25 | 25 | | In the One Hundred and Ninety-Fourth General Court |
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26 | 26 | | (2025-2026) |
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27 | 27 | | _______________ |
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28 | 28 | | An Act to enact the pharmacy benefit manager compensation reform. |
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29 | 29 | | Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority |
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30 | 30 | | of the same, as follows: |
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31 | 31 | | 1 The General Laws are hereby amended by inserting after Chapter 175M following new |
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32 | 32 | | 2chapter: |
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33 | 33 | | 3 CHAPTER 175N. Pharmacy Benefit Manager Compensation Reform Act of 2022 |
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34 | 34 | | 4 Section 1. Definitions |
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35 | 35 | | 5 As used in this chapter, the following words shall, unless the context clearly requires |
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36 | 36 | | 6otherwise, have the following meanings:— |
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37 | 37 | | 7 “Carrier”, any health insurance issuer that is subject to state law regulating insurance and |
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38 | 38 | | 8offers health insurance coverage, as defined in 42 U.S.C. § 300gg-91, or any state or local |
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39 | 39 | | 9governmental employer plan. 2 of 9 |
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40 | 40 | | 10 “Commissioner”, the commissioner of insurance. |
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41 | 41 | | 11 “Division”, the division of insurance. |
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42 | 42 | | 12 “Enrollee”, any individual entitled to coverage of health care services from a carrier. |
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43 | 43 | | 13 “Health benefit plan”, a policy, contract, certificate or agreement entered into, offered or |
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44 | 44 | | 14issued by a carrier to provide, deliver, arrange for, pay for, or reimburse any of the costs of |
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45 | 45 | | 15health care services. |
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46 | 46 | | 16 “Person”, a natural person, corporation, mutual company, unincorporated association, |
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47 | 47 | | 17partnership, joint venture, limited liability company, trust, estate, foundation, not-for-profit |
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48 | 48 | | 18corporation, unincorporated organization, government or governmental subdivision or agency. |
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49 | 49 | | 19 “Pharmacy benefit management fee”, a fee that covers the cost of providing one or more |
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50 | 50 | | 20pharmacy benefit management services and that does not exceed the value of the service or |
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51 | 51 | | 21services actually performed by the pharmacy benefit manager. |
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52 | 52 | | 22 “Pharmacy benefit management service”: |
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53 | 53 | | 23 (i) Negotiating the price of prescription drugs, including negotiating and contracting for |
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54 | 54 | | 24direct or indirect rebates, discounts, or other price concessions. |
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55 | 55 | | 25 (ii) Managing any aspect(s) of a prescription drug benefit, including but not limited to, |
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56 | 56 | | 26the processing and payment of claims for prescription drugs, the performance of utilization |
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57 | 57 | | 27review, the processing of drug prior authorization requests, the adjudication of appeals or |
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58 | 58 | | 28grievances related to the prescription drug benefit, contracting with network pharmacies, |
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59 | 59 | | 29controlling the cost of covered prescription drugs, managing data relating to the prescription drug |
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60 | 60 | | 30benefit, or the provision of services related thereto. 3 of 9 |
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61 | 61 | | 31 (iii) Performing any administrative, managerial, clinical, pricing, financial, |
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62 | 62 | | 32reimbursement, data administration or reporting, or billing service; and |
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63 | 63 | | 33 (vii) Such other services as the commissioner may define in regulation. |
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64 | 64 | | 34 “Pharmacy benefit manager”, any person that, pursuant to a written agreement with a |
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65 | 65 | | 35carrier or health benefit plan, either directly or indirectly, provides one or more pharmacy benefit |
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66 | 66 | | 36management services on behalf of the carrier or health benefit plan, and any agent, contractor, |
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67 | 67 | | 37intermediary, affiliate, subsidiary, or related entity of such person who facilitates, provides, |
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68 | 68 | | 38directs, or oversees the provision of the pharmacy benefit management services. |
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69 | 69 | | 39 “Pharmacy benefit manager duty”, a duty and obligation to perform pharmacy benefit |
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70 | 70 | | 40management services with care, skill, prudence, diligence, fairness, transparency, and |
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71 | 71 | | 41professionalism, and for the best interests of the enrollee, the health benefit plan, and the |
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72 | 72 | | 42provider, as consistent with the requirements of this section and any regulations that may be |
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73 | 73 | | 43adopted to implement this chapter. |
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74 | 74 | | 44 “Price protection rebate”, a negotiated price concession that accrues directly or indirectly |
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75 | 75 | | 45to the carrier or health benefit plan, or other party on behalf of the carrier or health benefit plan, |
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76 | 76 | | 46including a pharmacy benefit manager, in the event of an increase in the wholesale acquisition |
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77 | 77 | | 47cost of a drug above a specified threshold. |
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78 | 78 | | 48 “Provider”, an individual or entity that provides, dispenses, or administers one or more |
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79 | 79 | | 49units of a prescription drug. |
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80 | 80 | | 50 “Related entity”: 4 of 9 |
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81 | 81 | | 51 (i) any entity, whether foreign or domestic, that is a member of any controlled group of |
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82 | 82 | | 52corporations (as defined in section 1563(a) of the Internal Revenue Code, except that “50 |
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83 | 83 | | 53percent” shall be substituted for “80 percent” wherever the latter percentage appears in such |
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84 | 84 | | 54code) of which a pharmacy benefit manager is a member; or |
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85 | 85 | | 55 (ii) any of the following persons or entities that are treated as a related entity to the extent |
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86 | 86 | | 56provided in rules adopted by the commissioner: |
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87 | 87 | | 57 (A) a person other than a corporation that is treated under such rules as a related entity of |
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88 | 88 | | 58a pharmacy benefit manager, or |
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89 | 89 | | 59 (B) a person or entity that is treated under such rules as affiliated with a pharmacy benefit |
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90 | 90 | | 60manager in cases where the pharmacy benefit manager is a person other than a corporation. |
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91 | 91 | | 61 “Rebate”: |
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92 | 92 | | 62 (i) Negotiated price concessions including but not limited to base price concessions |
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93 | 93 | | 63(whether described as a “rebate” or otherwise) and reasonable estimates of any price protection |
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94 | 94 | | 64rebates and performance-based price concessions that may accrue directly or indirectly to the |
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95 | 95 | | 65carrier or health benefit plan, or other party on behalf of the carrier or health benefit plan, |
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96 | 96 | | 66including a pharmacy benefit manager, during the coverage year from a manufacturer, |
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97 | 97 | | 67dispensing pharmacy, or other party in connection with the dispensing or administration of a |
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98 | 98 | | 68prescription drug, and |
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99 | 99 | | 69 (ii) Reasonable estimates of any negotiated price concessions, fees and other |
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100 | 100 | | 70administrative costs that are passed through, or are reasonably anticipated to be passed through, |
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101 | 101 | | 71to the carrier or health benefit plan, or other party on behalf of the carrier or health benefit plan, 5 of 9 |
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102 | 102 | | 72including a pharmacy benefit manager, and serve to reduce the carrier or health benefit plan’s |
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103 | 103 | | 73liabilities for a prescription drug. |
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104 | 104 | | 74 “Spread pricing”, any amount charged or claimed by a pharmacy benefit manager in |
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105 | 105 | | 75excess of the ingredient cost for a dispensed prescription drug plus dispensing fee paid directly |
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106 | 106 | | 76or indirectly to any pharmacy, pharmacist, or other provider on behalf of the health benefit plan, |
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107 | 107 | | 77less a pharmacy benefit management fee. |
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108 | 108 | | 78 “Unaffiliated pharmacy”, any dispensing pharmacy that is not fractionally or wholly |
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109 | 109 | | 79owned by, or a subsidiary or an affiliate of, a pharmacy benefit manager. |
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110 | 110 | | 80 Section 2. Compensation and Prohibition on Spread Pricing |
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111 | 111 | | 81 (a) No pharmacy benefit manager may derive income from pharmacy benefit |
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112 | 112 | | 82management services provided to a carrier or health benefit plan in this state except for income |
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113 | 113 | | 83derived from a pharmacy benefit management fee. The amount of any pharmacy benefit |
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114 | 114 | | 84management fees must be set forth in the agreement between the pharmacy benefit manager and |
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115 | 115 | | 85the carrier or health benefit plan. |
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116 | 116 | | 86 (b) The pharmacy benefit management fee charged by or paid to a pharmacy benefit |
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117 | 117 | | 87manager from a carrier or health benefit plan shall not be directly or indirectly based or |
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118 | 118 | | 88contingent upon: |
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119 | 119 | | 89 (1) the acquisition cost or any other price metric of a drug; |
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120 | 120 | | 90 (2) the amount of savings, rebates, or other fees charged, realized, or collected by or |
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121 | 121 | | 91generated based on the activity of the pharmacy benefit manager; or 6 of 9 |
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122 | 122 | | 92 (3) the amount of premiums, deductibles, or other cost sharing or fees charged, realized, |
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123 | 123 | | 93or collected by the pharmacy benefit manager from patients or other persons on behalf of a |
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124 | 124 | | 94patient. |
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125 | 125 | | 95 (c) Annually by December 31, each pharmacy benefit manager operating in the state must |
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126 | 126 | | 96certify to the commissioner that it has fully and completely complied with the requirements of |
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127 | 127 | | 97this section throughout the prior calendar year. Such certification must be signed by the chief |
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128 | 128 | | 98executive officer or chief financial officer of the pharmacy benefit manager. |
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129 | 129 | | 99 (d) No pharmacy benefit manager, carrier, or health benefit plan may, either directly or |
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130 | 130 | | 100through an intermediary, agent, or affiliate engage in, facilitate, or enter into a contract with |
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131 | 131 | | 101another person involving spread pricing in this state. |
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132 | 132 | | 102 (e) A pharmacy benefit manager contract with a carrier or health benefit plan entered |
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133 | 133 | | 103into, renewed, or amended on or after the effective date this act must: |
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134 | 134 | | 104 (1) Specify all forms of revenue, including pharmacy benefit management fees, to be paid |
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135 | 135 | | 105by the carrier or health benefit plan to the pharmacy benefit manager; and |
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136 | 136 | | 106 (2) Acknowledge that spread pricing is not permitted in accordance with this section. |
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137 | 137 | | 107 Section 3. Audits of Pharmacy Benefit Managers |
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138 | 138 | | 108 (a) The commissioner and any carrier or health benefit plan contracted with a pharmacy |
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139 | 139 | | 109benefit manager holding a license issued by the division may audit the pharmacy benefit |
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140 | 140 | | 110manager once per calendar year. This audit right is in addition to, and shall not be construed to |
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141 | 141 | | 111limit, any other audit rights authorized by law or contract. As part of any such audit, the 7 of 9 |
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142 | 142 | | 112commissioner, carrier, or health benefit plan may request information including but not limited |
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143 | 143 | | 113to the following: |
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144 | 144 | | 114 (1) All reimbursement paid to retail pharmacies, on a claim level, for all customers of the |
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145 | 145 | | 115pharmacy benefit manager in the state, including drug-specific reimbursement, dispensing fees, |
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146 | 146 | | 116all rebates, other fees, ancillary charges, clawbacks, or adjustments to reimbursement; |
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147 | 147 | | 117 (2) Any difference in reimbursement paid to affiliated pharmacies and unaffiliated |
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148 | 148 | | 118pharmacies, including differences in reimbursed ingredient costs and dispensing fees; |
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149 | 149 | | 119 (3) Historical claims data including ingredient cost, quantity, dispensing fee, sales tax, |
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150 | 150 | | 120usual & customary price, channel (mail/retail), carrier or health benefit plan paid amount, days’ |
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151 | 151 | | 121supply, the amount paid by the covered individual, formulary tier, acquisition cost, and any |
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152 | 152 | | 122administrative fee associated with the claim, as applicable; and |
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153 | 153 | | 123 (4) Aggregate rebate amounts received directly or indirectly from manufacturers |
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154 | 154 | | 124(including from any other entity affiliated with or related to the pharmacy benefit manager that |
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155 | 155 | | 125negotiates or contracts with manufacturers, such as group purchasing organizations and rebate |
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156 | 156 | | 126aggregators) by calendar quarter. |
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157 | 157 | | 127 (b) The pharmacy benefit manager shall provide information referenced in subsection (a) |
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158 | 158 | | 128within thirty (30) days of its receipt of any request from the commissioner, carrier, or health |
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159 | 159 | | 129benefit plan. |
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160 | 160 | | 130 (c) The commissioner may dictate the form in which the pharmacy benefit manager will |
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161 | 161 | | 131provide information in response to an audit under subsection (a). 8 of 9 |
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162 | 162 | | 132 (d) The pharmacy benefit manager must certify that all information submitted to the |
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163 | 163 | | 133commissioner, or any carrier or health benefit plan in accordance with this section is accurate |
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164 | 164 | | 134and complete in all material respects. Such certification must be signed by the chief executive |
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165 | 165 | | 135officer or chief financial officer of the pharmacy benefit manager. |
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166 | 166 | | 136 (e) The commissioner and any carrier or health benefit plan contracted with a pharmacy |
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167 | 167 | | 137benefit manager holding a license issued by the division shall not directly or indirectly publish or |
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168 | 168 | | 138otherwise disclose any confidential, proprietary information, including but not limited to any |
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169 | 169 | | 139information that would reveal the identity of a specific health benefit plan or manufacturer, the |
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170 | 170 | | 140price(s) charged for a specific drug or class of drugs, the amount of any rebates provided for a |
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171 | 171 | | 141specific drug or class of drugs, or that would otherwise have the potential to compromise the |
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172 | 172 | | 142financial, competitive, or proprietary nature of the information. Such information shall be |
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173 | 173 | | 143considered to be a trade secret and confidential commercial information, shall not be considered |
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174 | 174 | | 144a public record, within the meaning of chapter sixty-six of the General Laws, and shall not be |
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175 | 175 | | 145disclosed directly or indirectly, or in a manner that would allow for the identification of an |
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176 | 176 | | 146individual product, therapeutic class of products, or manufacturer, or in a manner that would |
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177 | 177 | | 147have the potential to compromise the financial, competitive, or proprietary nature of the |
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178 | 178 | | 148information. The commissioner and any carrier or health benefit plan contracted with a pharmacy |
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179 | 179 | | 149benefit manager holding a license issued by the division shall impose the confidentiality |
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180 | 180 | | 150protections of this subsection on any vendor or downstream third party that may receive or have |
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181 | 181 | | 151access to this information. |
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182 | 182 | | 152 Section 4. Savings Clause 9 of 9 |
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183 | 183 | | 153 (a) In implementing the requirements of this Act, the state shall only regulate a pharmacy |
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184 | 184 | | 154benefit manager, carrier, or health benefit plan to the extent permissible under applicable law. |
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185 | 185 | | 155 (b) If any section, provision, or portion of this Act, including any condition or |
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186 | 186 | | 156prerequisite to any action or determination thereunder, is for any reason held to be illegal or |
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187 | 187 | | 157invalid, this illegality or invalidity shall not affect the remainder thereof or any other section, |
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188 | 188 | | 158provision, or portion of this Act, including any condition or prerequisite to any action or |
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189 | 189 | | 159determination thereunder, which shall be construed and enforced and applied as if such illegal or |
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190 | 190 | | 160invalid portion were not contained therein. |
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191 | 191 | | 161 Section 5. Penalties |
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192 | 192 | | 162 (a) If the commissioner determines that a pharmacy benefit manager is in violation of this |
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193 | 193 | | 163chapter or any rule or regulation promulgated under this chapter, the commissioner shall issue a |
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194 | 194 | | 164monetary penalty, suspend or revoke the pharmacy benefit manager’s license or take other action |
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195 | 195 | | 165that the commissioner deems necessary. |
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196 | 196 | | 166 (b) The commissioner shall issue rules and regulations to establish a process for |
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197 | 197 | | 167administrative appeal of any penalty, suspension or revocation imposed in accordance with this |
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198 | 198 | | 168section. |
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199 | 199 | | 169 Section 6. Rules |
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200 | 200 | | 170 The commissioner shall adopt any written policies, procedures or regulations the |
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201 | 201 | | 171commissioner determines necessary to implement this section. |
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