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2 | 2 | | HOUSE DOCKET, NO. 2602 FILED ON: 1/19/2023 |
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3 | 3 | | HOUSE . . . . . . . . . . . . . . . No. 1016 |
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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 | | Sean Garballey |
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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 pharmacy benefit manager duties. |
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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:Sean Garballey23rd Middlesex1/18/2023 1 of 6 |
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16 | 16 | | HOUSE DOCKET, NO. 2602 FILED ON: 1/19/2023 |
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17 | 17 | | HOUSE . . . . . . . . . . . . . . . No. 1016 |
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18 | 18 | | By Representative Garballey of Arlington, a petition (accompanied by bill, House, No. 1016) of |
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19 | 19 | | Sean Garballey relative to pharmacy benefit managers and the processing and payment of claims |
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20 | 20 | | for prescription drugs. Financial Services. |
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21 | 21 | | The Commonwealth of Massachusetts |
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22 | 22 | | _______________ |
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23 | 23 | | In the One Hundred and Ninety-Third General Court |
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24 | 24 | | (2023-2024) |
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25 | 25 | | _______________ |
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26 | 26 | | An Act to enact pharmacy benefit manager duties. |
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27 | 27 | | Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority |
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28 | 28 | | of the same, as follows: |
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29 | 29 | | 1 SECTION 1: The General Laws are hereby amended by inserting after Chapter 175M |
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30 | 30 | | 2following new chapter: |
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31 | 31 | | 3 CHAPTER 175N. Pharmacy Benefit Manager Duty of Care. |
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32 | 32 | | 4 Section 1. Definitions |
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33 | 33 | | 5 As used in this chapter, the following words shall, unless the context clearly requires |
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34 | 34 | | 6otherwise, have the following meanings:— |
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35 | 35 | | 7 “Carrier”, any health insurance issuer that is subject to state law regulating insurance and |
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36 | 36 | | 8offers health insurance coverage, as defined in 42 U.S.C. § 300gg-91, or any state or local |
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37 | 37 | | 9governmental employer plan. |
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38 | 38 | | 10 “Commissioner”, the commissioner of insurance. 2 of 6 |
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39 | 39 | | 11 “Division”, the division of insurance. |
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40 | 40 | | 12 “Enrollee”, any individual entitled to coverage of health care services from a carrier. |
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41 | 41 | | 13 “Health benefit plan”, a policy, contract, certificate, or agreement entered into, offered or |
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42 | 42 | | 14issued by a carrier to provide, deliver, arrange for, pay for, or reimburse any of the costs of |
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43 | 43 | | 15health care services. |
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44 | 44 | | 16 “Person”, a natural person, corporation, mutual company, unincorporated association, |
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45 | 45 | | 17partnership, joint venture, limited liability company, trust, estate, foundation, not-for-profit |
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46 | 46 | | 18corporation, unincorporated organization, government or governmental subdivision or agency. |
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47 | 47 | | 19 “Pharmacy benefit management fee”, a fee that covers the cost of providing one or more |
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48 | 48 | | 20pharmacy benefit management services and that does not exceed the value of the service or |
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49 | 49 | | 21services actually performed by the pharmacy benefit manager. |
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50 | 50 | | 22 “Pharmacy benefit management service”: |
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51 | 51 | | 23 (i) Negotiating the price of prescription drugs, including negotiating and contracting for |
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52 | 52 | | 24direct or indirect rebates, discounts, or other price concessions. |
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53 | 53 | | 25 (ii) Managing any aspect(s) of a prescription drug benefit, including but not limited to, |
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54 | 54 | | 26the processing and payment of claims for prescription drugs, the performance of utilization |
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55 | 55 | | 27review, the processing of drug prior authorization requests, the adjudication of appeals or |
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56 | 56 | | 28grievances related to the prescription drug benefit, contracting with network pharmacies, |
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57 | 57 | | 29controlling the cost of covered prescription drugs, managing data relating to the prescription drug |
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58 | 58 | | 30benefit, or the provision of services related thereto. 3 of 6 |
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59 | 59 | | 31 (iii) Performing any administrative, managerial, clinical, pricing, financial, |
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60 | 60 | | 32reimbursement, data administration or reporting, or billing service; and |
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61 | 61 | | 33 (iv) Such other services as the commissioner may define in regulation. |
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62 | 62 | | 34 “Pharmacy benefit manager”, any person that, pursuant to a written agreement with a |
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63 | 63 | | 35carrier or health benefit plan, either directly or indirectly, provides one or more pharmacy benefit |
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64 | 64 | | 36management services on behalf of the carrier or health benefit plan, and any agent, contractor, |
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65 | 65 | | 37intermediary, affiliate, subsidiary, or related entity of such person who facilitates, provides, |
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66 | 66 | | 38directs, or oversees the provision of the pharmacy benefit management services. |
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67 | 67 | | 39 “Pharmacy benefit manager duty”, a duty and obligation to perform pharmacy benefit |
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68 | 68 | | 40management services with care, skill, prudence, diligence, fairness, transparency, and |
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69 | 69 | | 41professionalism, and for the best interests of the enrollee, the health benefit plan, and the |
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70 | 70 | | 42provider, as consistent with the requirements of this section and any regulations that may be |
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71 | 71 | | 43adopted to implement this chapter. |
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72 | 72 | | 44 “Provider”, an individual or entity that provides, dispenses, or administers one or more |
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73 | 73 | | 45units of a prescription drug. |
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74 | 74 | | 46 “Related entity”: |
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75 | 75 | | 47 (i) any entity, whether foreign or domestic, that is a member of any controlled group of |
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76 | 76 | | 48corporations (as defined in section 1563(a) of the Internal Revenue Code, except that “50 |
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77 | 77 | | 49percent” shall be substituted for “80 percent” wherever the latter percentage appears in such |
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78 | 78 | | 50code) of which a pharmacy benefit manager is a member; or 4 of 6 |
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79 | 79 | | 51 (ii) any of the following persons or entities that are treated as a related entity to the extent |
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80 | 80 | | 52provided in rules adopted by the commissioner: |
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81 | 81 | | 53 (A) a person other than a corporation that is treated under such rules as a related entity of |
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82 | 82 | | 54a pharmacy benefit manager, or |
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83 | 83 | | 55 (B) a person or entity that is treated under such rules as affiliated with a pharmacy benefit |
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84 | 84 | | 56manager in cases where the pharmacy benefit manager is a person other than a corporation. |
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85 | 85 | | 57 “Spread pricing”, any amount charged or claimed by a pharmacy benefit manager in |
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86 | 86 | | 58excess of the ingredient cost for a dispensed prescription drug plus dispensing fee paid directly |
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87 | 87 | | 59or indirectly to any pharmacy, pharmacist, or other provider on behalf of the health benefit plan, |
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88 | 88 | | 60less a pharmacy benefit management fee. |
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89 | 89 | | 61 Section 2. Pharmacy Benefit Manager Duties |
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90 | 90 | | 62 (a) Pharmacy benefit manager duty. A pharmacy benefit manager shall owe the pharmacy |
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91 | 91 | | 63benefit manager duty to any enrollee, health benefit plan, or provider that receives pharmacy |
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92 | 92 | | 64benefit management services from the pharmacy benefit manager or that furnishes, covers, |
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93 | 93 | | 65receives, or is administered a unit of a prescription drug for which the pharmacy benefit manager |
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94 | 94 | | 66has provided pharmacy benefit management services. |
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95 | 95 | | 67 (1) Duty to enrollees. The pharmacy benefit manager duty owed to enrollees shall include |
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96 | 96 | | 68duties of care and good faith and fair dealing. The commissioner shall adopt regulations defining |
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97 | 97 | | 69the scope of the duties owed to enrollees, including by obligating pharmacy benefit managers to |
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98 | 98 | | 70provide all pharmacy benefit management services related to formulary design, utilization 5 of 6 |
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99 | 99 | | 71management, and grievances and appeals in a transparent manner to enrollees that is consistent |
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100 | 100 | | 72with the best interest of enrollees and to disclose all conflicts of interest to enrollees. |
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101 | 101 | | 73 (2) Duty to health benefit plans. The pharmacy benefit manager duty owed to health |
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102 | 102 | | 74benefit plans shall include duties of care and good faith and fair dealing. The commissioner shall |
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103 | 103 | | 75adopt regulations defining the scope of the duties owed to health benefit plans, including by |
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104 | 104 | | 76obligating pharmacy benefit managers to provide transparency to health benefit plans about |
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105 | 105 | | 77amounts charged or claimed by the pharmacy benefit manager in a manner that is adequate to |
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106 | 106 | | 78identify any instances of spread pricing and to disclose all conflicts of interest to health benefit |
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107 | 107 | | 79plans. |
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108 | 108 | | 80 (3) Duty to providers. The pharmacy benefit manager duty owed to providers shall |
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109 | 109 | | 81include duties of care and good faith and fair dealing. The commissioner shall adopt regulations |
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110 | 110 | | 82defining the scope of the duties owed to providers, including by obligating pharmacy benefit |
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111 | 111 | | 83managers to provide transparency to providers about amounts charged or claimed by the |
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112 | 112 | | 84pharmacy benefit manager in a manner that is adequate to identify any instances of spread |
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113 | 113 | | 85pricing and to disclose all conflicts of interest to providers. |
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114 | 114 | | 86 (b) Conflicts of interest. Where there is a conflict between the pharmacy benefit manager |
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115 | 115 | | 87duties owed under this section, the pharmacy benefit manager duty owed to an enrollee shall be |
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116 | 116 | | 88primary over the duty owed to any other party, and the pharmacy benefit manager duty owed to a |
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117 | 117 | | 89provider shall be primary over the duty owed to a health benefit plan. |
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118 | 118 | | 90 Section 3. Savings Clause |
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119 | 119 | | 91 (a) In implementing the requirements of this Act, the state shall only regulate a pharmacy |
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120 | 120 | | 92benefit manager, carrier, or health benefit plan to the extent permissible under applicable law. 6 of 6 |
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121 | 121 | | 93 (b) If any section, provision, or portion of this Act, including any condition or |
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122 | 122 | | 94prerequisite to any action or determination thereunder, is for any reason held to be illegal or |
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123 | 123 | | 95invalid, this illegality or invalidity shall not affect the remainder thereof or any other section, |
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124 | 124 | | 96provision, or portion of this Act, including any condition or prerequisite to any action or |
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125 | 125 | | 97determination thereunder, which shall be construed and enforced and applied as if such illegal or |
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126 | 126 | | 98invalid portion were not contained therein. |
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127 | 127 | | 99 Section 4. Penalties |
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128 | 128 | | 100 (a) If the commissioner determines that a pharmacy benefit manager is in violation of this |
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129 | 129 | | 101chapter or any rule or regulation promulgated under this chapter, the commissioner shall issue a |
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130 | 130 | | 102monetary penalty, suspend or revoke the pharmacy benefit manager’s license or take other action |
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131 | 131 | | 103that the commissioner deems necessary. |
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132 | 132 | | 104 (b) The commissioner shall issue rules and regulations to establish a process for |
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133 | 133 | | 105administrative appeal of any penalty, suspension or revocation imposed in accordance with this |
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134 | 134 | | 106section. |
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135 | 135 | | 107 Section 5. Rules |
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136 | 136 | | 108 The commissioner shall adopt any written policies, procedures, or regulations the |
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137 | 137 | | 109commissioner determines necessary to implement this section. |
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