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2 | 2 | | SENATE DOCKET, NO. 1264 FILED ON: 1/16/2025 |
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3 | 3 | | SENATE . . . . . . . . . . . . . . No. 831 |
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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 E. Tarr |
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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 ensure access to prescription medication and community pharmacies. |
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13 | 13 | | _______________ |
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14 | 14 | | PETITION OF: |
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15 | 15 | | NAME:DISTRICT/ADDRESS :Bruce E. TarrFirst Essex and Middlesex 1 of 8 |
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16 | 16 | | SENATE DOCKET, NO. 1264 FILED ON: 1/16/2025 |
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17 | 17 | | SENATE . . . . . . . . . . . . . . No. 831 |
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18 | 18 | | By Mr. Tarr, a petition (accompanied by bill, Senate, No. 831) of Bruce E. Tarr for legislation to |
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19 | 19 | | ensure access to prescription medication and community pharmacies. Financial Services. |
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20 | 20 | | The Commonwealth of Massachusetts |
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21 | 21 | | _______________ |
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22 | 22 | | In the One Hundred and Ninety-Fourth General Court |
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23 | 23 | | (2025-2026) |
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24 | 24 | | _______________ |
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25 | 25 | | An Act to ensure access to prescription medication and community pharmacies. |
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26 | 26 | | Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority |
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27 | 27 | | of the same, as follows: |
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28 | 28 | | 1 SECTION 1. Chapter 175 is hereby amended by adding the following new section:- |
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29 | 29 | | 2 Section 226A Contracts for Community Pharmacy Services |
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30 | 30 | | 3 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new |
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31 | 31 | | 4drug application approved under 21 U.S.C. 355(c) except for: (A) any drug approved through an |
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32 | 32 | | 5application submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that |
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33 | 33 | | 6is pharmaceutically equivalent, as that term is defined by the United States Food and Drug |
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34 | 34 | | 7Administration, to a drug approved under 21 U.S.C. 355(c); (B) an abbreviated new drug 407 |
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35 | 35 | | 8application that was approved by the United States Secretary of Health and Human Services |
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36 | 36 | | 9under section 505(c) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the |
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37 | 37 | | 10date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of |
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38 | 38 | | 1119 of 58 1984, Public Law 98-417, 98 Stat. 1585; or (C) an authorized generic drug as defined in |
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39 | 39 | | 1242 C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application 2 of 8 |
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40 | 40 | | 13approved 412 under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a |
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41 | 41 | | 14brand name drug based on available data resources such as Medi-Span. |
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42 | 42 | | 15 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an |
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43 | 43 | | 16abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic |
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44 | 44 | | 17drug as defined in 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962 |
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45 | 45 | | 18and was not originally marketed under a new drug application; or (iv) identified by the health |
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46 | 46 | | 19benefit plan as a generic drug based on available data resources such as Medi-Span. |
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47 | 47 | | 20 “Pharmacy Audit”, a process that involves the inspection of pharmacy records to ensure |
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48 | 48 | | 21high quality services and the lack of Fraud Waste, and Abuse. This includes desk audits as well |
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49 | 49 | | 22as in-person audits. |
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50 | 50 | | 23 “Pharmacy Benefit Manager” as defined in MGL c 175 Section 226 (a). |
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51 | 51 | | 24 Pharmacy Steering” A practice employed by a pharmacy benefit manager or carrier that |
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52 | 52 | | 25channels a prescription to a pharmacy in which a pharmacy benefit manager or carrier has an |
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53 | 53 | | 26ownership interest, and includes and is not limited to retail, mail order, or specialty pharmacy. |
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54 | 54 | | 27 “Specialty Medications” medications that have a complex profile that require intensive |
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55 | 55 | | 28patient management or special handling. |
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56 | 56 | | 29 Section 1: Network Pharmacies and Payment for pharmacy services |
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57 | 57 | | 30 A contract for pharmacy services between a pharmacy benefit manager and a pharmacy |
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58 | 58 | | 31must include an ingredient cost that meets the criteria in section 2 and a dispensing fee equal be |
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59 | 59 | | 32no less than what is paid by the State Medicaid Program. Payment for clean claims must include 3 of 8 |
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60 | 60 | | 33all applicable discounts. Contracts that include retroactive discounts and use “Generic Effective |
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61 | 61 | | 34Rate” or “Brand Effective Rate” or any other similar retroactive rate reductions are prohibited. |
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62 | 62 | | 35 Payment for pharmacy services to non-affiliated pharmacies must be equal to or greater |
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63 | 63 | | 36than payment to pharmacies affiliated with or owned by the pharmacy benefit manager. |
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64 | 64 | | 37 A pharmacy benefit manager shall not engage in pharmacy steering. |
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65 | 65 | | 38 A pharmacy benefit manager must allow any pharmacy licensed in Massachusetts to |
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66 | 66 | | 39provide any medication including “specialty medications” if the pharmacy is willing to provide |
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67 | 67 | | 40the required services. The required services must be the same among all pharmacies. |
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68 | 68 | | 41Requirements to provide specialty pharmacy medications cannot be designed to exclude |
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69 | 69 | | 42community pharmacies |
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70 | 70 | | 43 Section 2: Ingredient and Maximum Allowable Cost |
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71 | 71 | | 44 (a) For the purposes of this section the term "maximum allowable cost list" shall mean a |
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72 | 72 | | 45list of drugs, medical products or devices, or both medical products and devices, for which a |
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73 | 73 | | 46maximum allowable cost has been established by a pharmacy benefits manager or covered entity. |
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74 | 74 | | 47The term "maximum allowable cost" shall mean the maximum amount that a pharmacy benefits |
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75 | 75 | | 48manager or covered entity will reimburse a pharmacy for the cost of a drug or a medical product |
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76 | 76 | | 49or device inclusive of all discounts when the claim is processed or taken retroactively. |
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77 | 77 | | 50 (b) The maxim allowable cost (if used) or the ingredient cost (if not used) must be equal |
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78 | 78 | | 51to or greater than the cost used by the Massachusetts Medicaid Program 4 of 8 |
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79 | 79 | | 52 (c) The maximum allowable cost for non-affiliated pharmacies must be equal to or |
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80 | 80 | | 53greater than the maximum allowable cost to pharmacies affiliated with or owned by the |
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81 | 81 | | 54pharmacy benefit manager. |
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82 | 82 | | 55 (d) Before a pharmacy benefits manager or covered entity may place a drug on a |
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83 | 83 | | 56maximum allowable cost list the drug must be listed as "A" or "AB" rated in the most recent |
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84 | 84 | | 57version of the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, also |
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85 | 85 | | 58known as the Orange Book, or has an "NR" or "NA" rating or a similar rating by a nationally |
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86 | 86 | | 59recognized reference; and that there are at least two therapeutically equivalent, multiple source |
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87 | 87 | | 60drugs, or at least one generic drug available from one manufacturer, available for purchase by |
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88 | 88 | | 61network pharmacies from national or regional wholesalers registered in Massachusetts. |
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89 | 89 | | 62 (e) A pharmacy benefits manager or covered entity shall make available to each |
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90 | 90 | | 63pharmacy with which the pharmacy benefits manager or covered entity has a contract and to |
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91 | 91 | | 64each pharmacy included in a network of pharmacies served by a pharmacy services |
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92 | 92 | | 65administrative organization with which the pharmacy benefits manager or covered entity has a |
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93 | 93 | | 66contract, at the beginning of the term of a contract upon renewal of a contract, or upon request: |
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94 | 94 | | 67 (1) The sources used to determine the maximum allowable costs for the drugs and |
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95 | 95 | | 68medical products and devices on each maximum allowable cost list; |
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96 | 96 | | 69 (2) Every maximum allowable cost for individual drugs used by that pharmacy benefits |
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97 | 97 | | 70manager or covered entity for patients served by that contracted pharmacy; and |
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98 | 98 | | 71 (3) Upon request, every maximum allowable cost list used by that pharmacy benefits |
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99 | 99 | | 72manager or covered entity for patients served by that contracted pharmacy. 5 of 8 |
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100 | 100 | | 73 (f) A pharmacy benefits manager or covered entity shall: |
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101 | 101 | | 74 (1) update each maximum allowable cost list at least every 3 business days |
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102 | 102 | | 75 (2) Make the updated lists available to every pharmacy with which the pharmacy benefits |
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103 | 103 | | 76manager or covered entity has a contract and to every pharmacy included in a network of |
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104 | 104 | | 77pharmacies served by a pharmacy services administrative organization with which the pharmacy |
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105 | 105 | | 78benefits manager or covered entity has a contract, in a readily accessible, secure and usable web- |
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106 | 106 | | 79based format or other comparable format or process; and |
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107 | 107 | | 80 (3) Utilize the updated maximum allowable costs to calculate the payments made to the |
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108 | 108 | | 81contracted pharmacies within 2 business days. |
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109 | 109 | | 82 (g) A pharmacy benefits manager or covered entity shall establish a clearly defined |
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110 | 110 | | 83process through which a pharmacy may contest the cost for a particular drug or medical product |
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111 | 111 | | 84or device. |
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112 | 112 | | 85 (h) A pharmacy may base its appeal on one or more of the following: |
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113 | 113 | | 86 (1) The ingredient cost established for a particular drug or medical product, or device is |
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114 | 114 | | 87below the cost used by the Massachusetts Medicaid Program |
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115 | 115 | | 88 (2) The pharmacy benefits manager or covered entity has placed a drug on the maximum |
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116 | 116 | | 89allowable cost list that does not meet the requirements of subsection (d). |
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117 | 117 | | 90 (i) The pharmacy must file its appeal within seven business days of its submission of the |
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118 | 118 | | 91initial claim for reimbursement for the drug or medical product or device. A Pharmacy Services |
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119 | 119 | | 92Administrative Organization (PSAO) may appeal on behalf of a pharmacy or group of |
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120 | 120 | | 93pharmacies. The pharmacy benefits manager or covered entity must make a final determination 6 of 8 |
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121 | 121 | | 94resolving the pharmacy's appeal within seven business days of the pharmacy benefits manager or |
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122 | 122 | | 95covered entity's receipt of the appeal. |
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123 | 123 | | 96 (j) If the final determination is a denial of the pharmacy's appeal, the pharmacy benefits |
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124 | 124 | | 97manager or covered entity must state the reason for the denial and provide the national drug code |
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125 | 125 | | 98of an equivalent drug that is generally available for purchase by pharmacies in this state from |
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126 | 126 | | 99national or regional wholesalers licensed by the state at a price which is equal to or less than the |
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127 | 127 | | 100cost for that drug. |
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128 | 128 | | 101 (k) If a pharmacy's appeal is determined to be valid by the pharmacy benefits manager or |
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129 | 129 | | 102covered entity, the pharmacy benefits manager or covered entity shall retroactively adjust the |
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130 | 130 | | 103cost of the drug or medical product or device and reprocess all claims that were paid incorrectly. |
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131 | 131 | | 104The adjustment shall be effective from the date the pharmacy's appeal was filed, and the |
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132 | 132 | | 105pharmacy benefits manager or covered entity shall provide reimbursement for all reprocessed |
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133 | 133 | | 106claims. |
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134 | 134 | | 107 (l) Once a pharmacy's appeal is determined to be valid by the pharmacy benefits manager |
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135 | 135 | | 108or covered entity, the pharmacy benefits manager or covered entity shall adjust the cost of the |
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136 | 136 | | 109drug or medical product or device for all similar pharmacies in the network as determined by the |
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137 | 137 | | 110pharmacy benefits manager within 3 business days. |
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138 | 138 | | 111 (m) A pharmacy benefits manager or covered entity shall make available on its secure |
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139 | 139 | | 112web site information about the appeals process, including, but not limited to, a telephone number |
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140 | 140 | | 113or process that a pharmacy may use to submit cost appeals. The medical products and devices |
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141 | 141 | | 114subject to the requirements of this part are limited to the medical products and devices included |
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142 | 142 | | 115as a pharmacy benefit under the pharmacy benefits contract. 7 of 8 |
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143 | 143 | | 116 (n) A pharmacy shall not disclose to any third party the cost lists and any related |
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144 | 144 | | 117information it receives from a pharmacy benefits manager or covered entity; provided, a |
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145 | 145 | | 118pharmacy may share such lists and related information with a pharmacy services administrative |
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146 | 146 | | 119organization or similar entity with which the pharmacy has a contract to provide administrative |
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147 | 147 | | 120services for that pharmacy. If a pharmacy shares this information with a pharmacy services |
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148 | 148 | | 121administrative organization or similar entity, that organization or entity shall not disclose the |
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149 | 149 | | 122information to any third party. |
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150 | 150 | | 123 (o) If a generic medication is readily available from a wholesaler licensed in |
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151 | 151 | | 124Massachusetts, a pharmacy benefit manager is prohibited from requiring the brand name be used |
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152 | 152 | | 125or giving any financial incentive to a pharmacy or patient to use the brand name product. The |
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153 | 153 | | 126Massachusetts Medicaid program is exempt from this requirement. |
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154 | 154 | | 127 (p) Pharmacy Benefit Managers shall provide annually a report to the Commissioner that |
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155 | 155 | | 128details all denied pharmacy appeals for that year to include: the name of the pharmacy, date of |
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156 | 156 | | 129service for the claim, the drug name and billing code used on the claim, the amount billed, the |
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157 | 157 | | 130amount paid, and the reason for the denial. |
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158 | 158 | | 131 Section 3: If during a pharmacy audit, the pharmacy can use signature logs or statements |
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159 | 159 | | 132from the prescriber obtained after the audit to validate the intent of a prescription or medication |
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160 | 160 | | 133order. If the pharmacy provided the intended medication to the patient but there was a clerical |
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161 | 161 | | 134error (with no financial or clinical impact), the pharmacy benefit manager is prohibited from |
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162 | 162 | | 135recouping the ingredient cost and can only recoup the dispensing fee. All revenue from |
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163 | 163 | | 136pharmacy audits must be given to the plan sponsor. 8 of 8 |
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164 | 164 | | 137 Section 4: A pharmacy benefit manager is prohibited from charging a community |
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165 | 165 | | 138pharmacy for credentialing. |
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166 | 166 | | 139 Section 5: The Insurance Commissioner shall enforce this act and shall promulgate |
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167 | 167 | | 140regulations to enforce the provisions of this act. The commissioner may examine or audit the |
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168 | 168 | | 141books and records of a pharmacy benefits manager providing claims processing services or other |
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169 | 169 | | 142prescription drug or device services for a health benefit plan to determine if the pharmacy |
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170 | 170 | | 143benefits manager is in compliance with this act. The information or data acquired during an |
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171 | 171 | | 144examination is: |
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172 | 172 | | 145 (a) Considered proprietary and confidential; and |
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173 | 173 | | 146 (b) Not subject to the Freedom of Information Act of Massachusetts |
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