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2 | 2 | | HOUSE DOCKET, NO. 2356 FILED ON: 1/16/2025 |
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3 | 3 | | HOUSE . . . . . . . . . . . . . . . No. 1325 |
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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 | | Alan Silvia |
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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 generic medication. |
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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:Alan Silvia7th Bristol1/16/2025 1 of 6 |
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16 | 16 | | HOUSE DOCKET, NO. 2356 FILED ON: 1/16/2025 |
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17 | 17 | | HOUSE . . . . . . . . . . . . . . . No. 1325 |
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18 | 18 | | By Representative Silvia of Fall River, a petition (accompanied by bill, House, No. 1325) of |
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19 | 19 | | Alan Silvia relative to access to generic medications. Financial Services. |
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20 | 20 | | [SIMILAR MATTER FILED IN PREVIOUS SESSION |
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21 | 21 | | SEE HOUSE, NO. 1150 OF 2023-2024.] |
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22 | 22 | | The Commonwealth of Massachusetts |
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23 | 23 | | _______________ |
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24 | 24 | | In the One Hundred and Ninety-Fourth General Court |
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25 | 25 | | (2025-2026) |
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26 | 26 | | _______________ |
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27 | 27 | | An Act to ensure access to generic medication. |
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28 | 28 | | Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority |
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29 | 29 | | of the same, as follows: |
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30 | 30 | | 1 Chapter 176D is hereby amended by adding, after section 3B, the following section:- |
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31 | 31 | | 2 Section 3C. (a) For the purposes of this section the term "maximum allowable cost list" |
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32 | 32 | | 3shall mean a list of drugs, medical products or devices, or both medical products and devices, for |
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33 | 33 | | 4which a maximum allowable cost has been established by a pharmacy benefits manager or |
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34 | 34 | | 5covered entity. The term "maximum allowable cost" shall mean the maximum amount that a |
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35 | 35 | | 6pharmacy benefits manager or covered entity will reimburse a pharmacy for the cost of a drug or |
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36 | 36 | | 7a medical product or device. |
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37 | 37 | | 8 (b) Before a pharmacy benefits manager or covered entity may place a drug on a |
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38 | 38 | | 9maximum allowable cost list the drug must be listed as "A" or "AB" rated in the most recent |
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39 | 39 | | 10version of the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, also 2 of 6 |
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40 | 40 | | 11known as the Orange Book, or has an "NR" or "NA" rating or a similar rating by a nationally |
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41 | 41 | | 12recognized reference; and that there are at least two therapeutically equivalent, multiple source |
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42 | 42 | | 13drugs, or at least one generic drug available from one manufacturer, available for purchase by |
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43 | 43 | | 14network pharmacies from national or regional wholesalers. |
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44 | 44 | | 15 (c) If a drug that has been placed on a maximum allowable cost list no longer meets the |
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45 | 45 | | 16requirements of subsection (a), the drug shall be removed from the maximum allowable cost list |
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46 | 46 | | 17by the pharmacy benefits manager or covered entity within 3 business days after the drug no |
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47 | 47 | | 18longer meets the requirements of subsection (a). |
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48 | 48 | | 19 (d) A pharmacy benefits manager or covered entity shall make available to each |
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49 | 49 | | 20pharmacy with which the pharmacy benefits manager or covered entity has a contract and to |
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50 | 50 | | 21each pharmacy included in a network of pharmacies served by a pharmacy services |
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51 | 51 | | 22administrative organization with which the pharmacy benefits manager or covered entity has a |
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52 | 52 | | 23contract, at the beginning of the term of a contract upon renewal of a contract, or upon request: |
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53 | 53 | | 24 (1) The sources used to determine the maximum allowable costs for the drugs and |
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54 | 54 | | 25medical products and devices on each maximum allowable cost list; |
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55 | 55 | | 26 (2) Every maximum allowable cost for individual drugs used by that pharmacy benefits |
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56 | 56 | | 27manager or covered entity for patients served by that contracted pharmacy; and |
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57 | 57 | | 28 (3) Upon request, every maximum allowable cost list used by that pharmacy benefits |
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58 | 58 | | 29manager or covered entity for patients served by that contracted pharmacy. |
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59 | 59 | | 30 (e) A pharmacy benefits manager or covered entity shall: 3 of 6 |
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60 | 60 | | 31 (1) Ensure the maxim allowable cost is equal to or greater than the pharmacies |
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61 | 61 | | 32acquisition cost and update each maximum allowable cost list at least every 3 business days; |
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62 | 62 | | 33 (2) Make the updated lists available to every pharmacy with which the pharmacy benefits |
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63 | 63 | | 34manager or covered entity has a contract and to every pharmacy included in a network of |
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64 | 64 | | 35pharmacies served by a pharmacy services administrative organization with which the pharmacy |
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65 | 65 | | 36benefits manager or covered entity has a contract, in a readily accessible, secure and usable web- |
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66 | 66 | | 37based format or other comparable format or process; and |
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67 | 67 | | 38 (3) Utilize the updated maximum allowable costs to calculate the payments made to the |
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68 | 68 | | 39contracted pharmacies within 2 business days. |
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69 | 69 | | 40 (f) A pharmacy benefits manager or covered entity shall establish a clearly defined |
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70 | 70 | | 41process through which a pharmacy may contest the listed maximum allowable cost for a |
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71 | 71 | | 42particular drug or medical product or device. |
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72 | 72 | | 43 (g) A pharmacy may base its appeal on one or more of the following: |
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73 | 73 | | 44 (1) The maximum allowable cost established for a particular drug or medical product or |
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74 | 74 | | 45device is below the cost at which the drug or medical product or device is generally available for |
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75 | 75 | | 46purchase by Massachusetts licensed wholesalers currently operating in the state; or |
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76 | 76 | | 47 (2) The pharmacy benefits manager or covered entity has placed a drug on the list |
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77 | 77 | | 48without properly determining that the requirements of subsection (a). |
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78 | 78 | | 49 (h) The pharmacy must file its appeal within seven business days of its submission of the |
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79 | 79 | | 50initial claim for reimbursement for the drug or medical product or device. The pharmacy benefits |
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80 | 80 | | 51manager or covered entity must make a final determination resolving the pharmacy's appeal 4 of 6 |
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81 | 81 | | 52within seven business days of the pharmacy benefits manager or covered entity's receipt of the |
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82 | 82 | | 53appeal. |
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83 | 83 | | 54 (i) If the final determination is a denial of the pharmacy's appeal, the pharmacy benefits |
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84 | 84 | | 55manager or covered entity must state the reason for the denial and provide the national drug code |
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85 | 85 | | 56of an equivalent drug that is generally available for purchase by pharmacies in this state from |
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86 | 86 | | 57national or regional wholesalers licensed by the state at a price which is equal to or less than the |
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87 | 87 | | 58maximum allowable cost for that drug. |
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88 | 88 | | 59 (j) If a pharmacy's appeal is determined to be valid by the pharmacy benefits manager or |
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89 | 89 | | 60covered entity, the pharmacy benefits manager or covered entity shall adjust the maximum |
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90 | 90 | | 61allowable cost of the drug or medical product or device for the appealing pharmacy. The |
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91 | 91 | | 62adjustment for the appealing pharmacy shall be effective from the date the pharmacy's appeal |
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92 | 92 | | 63was filed, and the pharmacy benefits manager or covered entity shall provide reimbursement to |
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93 | 93 | | 64the appealing pharmacy and may require the appealing pharmacy to reverse and rebill the claim |
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94 | 94 | | 65in question in order to receive the corrected reimbursement. |
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95 | 95 | | 66 (k) Once a pharmacy's appeal is determined to be valid by the pharmacy benefits manager |
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96 | 96 | | 67or covered entity, the pharmacy benefits manager or covered entity shall adjust the maximum |
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97 | 97 | | 68allowable cost of the drug or medical product or device to which the maximum allowable cost |
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98 | 98 | | 69applies for all similar pharmacies in the network as determined by the pharmacy benefits |
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99 | 99 | | 70manager within 3 business days. |
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100 | 100 | | 71 (l) A pharmacy benefits manager or covered entity shall make available on its secure web |
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101 | 101 | | 72site information about the appeals process, including, but not limited to, a telephone number or |
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102 | 102 | | 73process that a pharmacy may use to submit maximum allowable cost appeals. The medical 5 of 6 |
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103 | 103 | | 74products and devices subject to the requirements of this part are limited to the medical products |
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104 | 104 | | 75and devices included as a pharmacy benefit under the pharmacy benefits contract. |
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105 | 105 | | 76 (m) A pharmacy shall not disclose to any third party the maximum allowable cost lists |
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106 | 106 | | 77and any related information it receives from a pharmacy benefits manager or covered entity; |
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107 | 107 | | 78provided, a pharmacy may share such lists and related information with a pharmacy services |
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108 | 108 | | 79administrative organization or similar entity with which the pharmacy has a contract to provide |
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109 | 109 | | 80administrative services for that pharmacy. If a pharmacy shares this information with a pharmacy |
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110 | 110 | | 81services administrative organization or similar entity, that organization or entity shall not |
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111 | 111 | | 82disclose the information to any third party. |
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112 | 112 | | 83 (n) The Insurance Commissioner shall enforce this Act and may promulgate regulations |
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113 | 113 | | 84to enforce the provisions of this act. The commissioner may examine or audit the books and |
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114 | 114 | | 85records of a pharmacy benefits manager providing claims processing services or other |
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115 | 115 | | 86prescription drug or device services for a health benefit plan to determine if the pharmacy |
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116 | 116 | | 87benefits manager is in compliance with this Act. The information or data acquired during an |
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117 | 117 | | 88examination is: |
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118 | 118 | | 89 (i) Considered proprietary and confidential; and |
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119 | 119 | | 90 (ii) Not subject to the Freedom of Information Act of Massachusetts |
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120 | 120 | | 91 (o) In any participation contracts between pharmacy benefits managers and pharmacists |
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121 | 121 | | 92or pharmacies providing prescription drug coverage for health benefit plans, no pharmacy or |
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122 | 122 | | 93pharmacist may be prohibited, restricted, or penalized in any way from disclosing to any covered |
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123 | 123 | | 94person any healthcare information that the pharmacy or pharmacist deems appropriate regarding |
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124 | 124 | | 95the nature of treatment, risks, or alternatives thereto, the availability of alternate therapies, 6 of 6 |
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125 | 125 | | 96consultations, or tests, the decision of utilization reviewers or similar persons to authorize or |
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126 | 126 | | 97deny services, the process that is used to authorize or deny healthcare services or benefits, or |
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127 | 127 | | 98information on financial incentives and structures used by the insurer. |
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128 | 128 | | 99 (p) Further any such contract as stated above shall not prohibit a pharmacist or pharmacy |
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129 | 129 | | 100from providing an insured individual information on the amount of the insured's cost share for |
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130 | 130 | | 101such insured's prescription drug and the clinical efficacy of a more affordable alternative drug if |
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131 | 131 | | 102one is available. Neither a pharmacy nor a pharmacist shall be penalized by a pharmacy benefits |
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132 | 132 | | 103manager for disclosing such information to an insured or for selling to an insured a more |
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133 | 133 | | 104affordable alternative if one is available. |
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