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2 | 2 | | SENATE DOCKET, NO. 1797 FILED ON: 1/16/2025 |
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3 | 3 | | SENATE . . . . . . . . . . . . . . No. 724 |
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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 | | Sal N. DiDomenico |
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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 promoting healthcare access and affordability for patients. |
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13 | 13 | | _______________ |
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14 | 14 | | PETITION OF: |
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15 | 15 | | NAME:DISTRICT/ADDRESS :Sal N. DiDomenicoMiddlesex and Suffolk 1 of 5 |
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16 | 16 | | SENATE DOCKET, NO. 1797 FILED ON: 1/16/2025 |
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17 | 17 | | SENATE . . . . . . . . . . . . . . No. 724 |
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18 | 18 | | By Mr. DiDomenico, a petition (accompanied by bill, Senate, No. 724) of Sal N. DiDomenico |
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19 | 19 | | for legislation to promote healthcare access and affordability for patients. 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 promoting healthcare access and affordability for patients. |
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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. Sections 131 and 226 of chapter 139 of the acts of 2012 are hereby |
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29 | 29 | | 2repealed. |
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30 | 30 | | 3 SECTION 2. Chapter 176O of the General Laws is hereby amended by adding the |
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31 | 31 | | 4following section:- |
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32 | 32 | | 5 Section 31. (a) As used in this section, the following words shall, unless the context |
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33 | 33 | | 6clearly requires otherwise, have the following meanings: |
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34 | 34 | | 7 “Cost-sharing”, as defined in subsection (a) of section 21C of chapter 94C. |
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35 | 35 | | 8 “Estimated rebate”, any: (i) negotiated price concessions, whether described as a rebate |
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36 | 36 | | 9or otherwise, including, but not limited to, base price concessions, and reasonable estimates of |
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37 | 37 | | 10any price protection rebates and performance-based price concessions that may accrue, directly |
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38 | 38 | | 11or indirectly, to a carrier, pharmacy benefit manager or other party on a carrier’s behalf during a |
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39 | 39 | | 12carrier’s plan year from a pharmaceutical manufacturing company, dispensing pharmacy or other 2 of 5 |
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40 | 40 | | 13party to the transaction based on the amounts the carrier received in the prior quarter or |
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41 | 41 | | 14reasonably expects to receive in the current quarter; and (ii) reasonable estimates of any price |
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42 | 42 | | 15concessions, fees and other administrative costs that are passed through, or are reasonably |
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43 | 43 | | 16anticipated to be passed through to the carrier, pharmacy benefit manager or other party on the |
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44 | 44 | | 17carrier’s behalf and that serve to reduce the carrier’s prescription drug liabilities for the plan year |
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45 | 45 | | 18based on the amounts the carrier received in the prior quarter or reasonably expects to receive in |
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46 | 46 | | 19the current quarter. |
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47 | 47 | | 20 “Pharmacy benefit manager”, as defined in section 1 of chapter 176Y. |
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48 | 48 | | 21 “Price protection rebate”, a negotiated price concession that accrues directly or indirectly |
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49 | 49 | | 22to the carrier, or other party on behalf of the carrier, including a pharmacy benefit manager, in |
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50 | 50 | | 23the event of an increase in the wholesale acquisition cost of a drug that is greater than a specified |
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51 | 51 | | 24threshold. |
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52 | 52 | | 25 (b) A carrier, or any pharmacy benefit manager, shall make available to an insured at |
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53 | 53 | | 26least 80 per cent of the estimated rebates received by such carrier, or any pharmacy benefit |
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54 | 54 | | 27manager, by reducing the amount of defined cost-sharing that the carrier would otherwise charge |
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55 | 55 | | 28at the point of sale, except that the reduction amount shall not result in a credit at the point of |
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56 | 56 | | 29sale. Neither the insured nor the carrier shall be responsible for any difference between the |
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57 | 57 | | 30estimated rebate amount and the actual rebate amount the carrier receives; provided, that such |
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58 | 58 | | 31estimates were calculated in good faith. |
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59 | 59 | | 32 (c) Nothing in this section shall preclude a pharmacy benefit manager from decreasing an |
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60 | 60 | | 33insured’s defined cost-sharing by an amount greater than that required under subsection (b). 3 of 5 |
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61 | 61 | | 34 (d) Annually, not later than April 1, a carrier shall file with the division a report in the |
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62 | 62 | | 35manner and form determined by the commissioner demonstrating the manner in which the carrier |
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63 | 63 | | 36has complied with this section. If the commissioner determines that a carrier has not complied |
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64 | 64 | | 37with 1 or more requirements of this section, the commissioner shall notify the carrier of such |
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65 | 65 | | 38noncompliance and a date by which the carrier must demonstrate compliance. If the carrier does |
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66 | 66 | | 39not come into compliance by such date, the division shall impose a fine not to exceed $5,000 for |
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67 | 67 | | 40each day during which such noncompliance continues. |
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68 | 68 | | 41 (e) In implementing the requirements of this section, the division shall only regulate a |
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69 | 69 | | 42carrier or pharmacy benefit manager to the extent permissible under applicable law. |
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70 | 70 | | 43 (f) A pharmacy benefit manager, its agent or any third-party administrator shall not |
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71 | 71 | | 44publish or otherwise disclose information regarding the actual amount of rebates a carrier |
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72 | 72 | | 45receives on a specific product or therapeutic class of products, manufacturer or pharmacy- |
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73 | 73 | | 46specific basis. Such information shall be considered to be a trade secret and confidential |
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74 | 74 | | 47commercial information, shall not be a public record as defined by clause Twenty-sixth of |
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75 | 75 | | 48section 7 of chapter 4 or section 10 of chapter 66, and shall not be disclosed directly or |
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76 | 76 | | 49indirectly, or in a manner that would allow for the identification of an individual product, |
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77 | 77 | | 50therapeutic class of products or manufacturer, or in a manner that would have the potential to |
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78 | 78 | | 51compromise the financial, competitive or proprietary nature of the information. A pharmacy |
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79 | 79 | | 52benefit manager shall impose the confidentiality protections and requirements of this section on |
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80 | 80 | | 53any agent or third-party administrator that performs health care or administrative services on |
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81 | 81 | | 54behalf of the pharmacy benefit manager that may receive or have access to rebate related |
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82 | 82 | | 55information. 4 of 5 |
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83 | 83 | | 56 SECTION 3. (a) Notwithstanding any general or special law to the contrary, the health |
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84 | 84 | | 57policy commission, together with the secretary of the executive office of health and human |
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85 | 85 | | 58services, shall conduct an analysis and issue a report on the future of cell and gene therapy in the |
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86 | 86 | | 59commonwealth with the objective of addressing anticipated barriers to access that may exist with |
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87 | 87 | | 60respect to such treatments for patients covered by MassHealth programs and other vulnerable |
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88 | 88 | | 61populations. The analysis and report shall include, but not be limited to: |
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89 | 89 | | 62 (1) a projection of the estimated total number of cell and gene therapy products, including |
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90 | 90 | | 63information on the diseases and conditions such products will be approved to treat (including the |
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91 | 91 | | 64total estimated number of lives impacted in the commonwealth, and the total number receiving |
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92 | 92 | | 65care under MassHealth), that are expected to come to market in the U.S. (hereinafter the |
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93 | 93 | | 66“products”) during a forecast period of 2027 to 2037 (hereinafter, the “forecast period”); |
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94 | 94 | | 67 (2) an assessment of existing reimbursement frameworks and methodologies employed |
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95 | 95 | | 68by MassHealth for the products to the extent purchased by health care facilities for |
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96 | 96 | | 69administration to MassHealth beneficiaries during inpatient hospital stays; |
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97 | 97 | | 70 (3) an assessment of whether the reimbursement frameworks and methodologies |
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98 | 98 | | 71identified in subdivision (2) would lead to barriers to access to the products during the forecast |
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99 | 99 | | 72period in light of the projected costs to the Massachusetts health care system associated with the |
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100 | 100 | | 73utilization of the products, and whether such barriers to access, if any, would disproportionately |
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101 | 101 | | 74impact MassHealth beneficiaries or other vulnerable populations, including population groups |
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102 | 102 | | 75that may be more likely to have adverse health outcomes due to experience with historic |
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103 | 103 | | 76disparities or discrimination, including racial or ethnic minority population groups; 5 of 5 |
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104 | 104 | | 77 (4) An assessment of whether the health care facility infrastructure in place and planned |
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105 | 105 | | 78for development during the forecast period, and that is necessary of the administration of the |
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106 | 106 | | 79products, will be adequate to ensure equitable access for patients in need of treatment with the |
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107 | 107 | | 80products. |
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108 | 108 | | 81 (b) To the extent that the analysis required under subdivision (3) of subsection (a) |
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109 | 109 | | 82identifies any barriers to access, the commission and the secretary shall analyze and report on the |
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110 | 110 | | 83reasons for such barriers and shall propose corrective policy solutions. If any identified barriers |
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111 | 111 | | 84are the result of or otherwise related to current MassHealth reimbursement methodologies for |
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112 | 112 | | 85gene and cell therapies, the commission and the secretary shall propose modifications to such |
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113 | 113 | | 86methodologies to the extent authorized under Federal law. Such proposed modifications shall |
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114 | 114 | | 87address and be designed to eliminate any disproportionate impact of the access barriers on |
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115 | 115 | | 88MassHealth beneficiaries or other vulnerable populations. |
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116 | 116 | | 89 (c) In conducting the analysis and producing the report as required by subsection (a), the |
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117 | 117 | | 90secretary and the commission shall consult with the Massachusetts Biotechnology Council or a |
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118 | 118 | | 91designee, the Massachusetts Hospital Association or a designee, the Conference of Boston |
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119 | 119 | | 92Teaching Hospitals or a designee, and the rare disease advisory council established pursuant to |
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120 | 120 | | 93section 26 of chapter 260 of the acts of 2020. |
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121 | 121 | | 94 (d) The report shall be made available electronically on the commission’s website, and |
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122 | 122 | | 95shall be filed with the secretary of administration and finance, the clerks of the house of |
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123 | 123 | | 96representatives and the senate, the house and senate committees on ways and means and the joint |
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124 | 124 | | 97committee on health care financing no later than July 30, 2028. |
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