1 | 1 | | SENATE . . . . . . . . . . . . . . No. 2871 |
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2 | 2 | | The Commonwealth of Massachusetts |
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3 | 3 | | _______________ |
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4 | 4 | | In the One Hundred and Ninety-Third General Court |
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5 | 5 | | (2023-2024) |
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6 | 6 | | _______________ |
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7 | 7 | | SENATE, July 15, 2024. |
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8 | 8 | | The committee on Senate Ways and Means to whom was referred the House Bill |
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9 | 9 | | enhancing the market review process (House, No. 4653); reports, recommending that the same |
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10 | 10 | | ought to pass with an amendment striking out all after the enacting clause and inserting in place |
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11 | 11 | | thereof the text of Senate document numbered 2871; and by striking out the title and inserting in |
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12 | 12 | | place thereof the following title "An Act enhancing the health care market review process". |
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13 | 13 | | For the committee, |
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14 | 14 | | Michael J. Rodrigues 2 of 119 |
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15 | 15 | | SENATE . . . . . . . . . . . . . . No. 2871 |
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16 | 16 | | The Commonwealth of Massachusetts |
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17 | 17 | | _______________ |
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18 | 18 | | In the One Hundred and Ninety-Third General Court |
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19 | 19 | | (2023-2024) |
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20 | 20 | | _______________ |
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21 | 21 | | 1 SECTION 1. Section 16 of chapter 6A of the General Laws, as appearing in the 2022 |
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22 | 22 | | 2Official Edition, is hereby amended by striking out, in lines 24 to 26, inclusive, the words “, the |
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23 | 23 | | 3division of medical assistance and the Betsy Lehman center for patient safety and medical error |
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24 | 24 | | 4reduction” and inserting in place thereof the following words:- and the division of medical |
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25 | 25 | | 5assistance. |
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26 | 26 | | 6 SECTION 2. Section 16D of said chapter 6A, as so appearing, is hereby amended by |
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27 | 27 | | 7striking out, in lines 22 to 24, inclusive, the words “department of public health established by |
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28 | 28 | | 8section 217 of chapter 111” and inserting in place thereof the following words:- health policy |
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29 | 29 | | 9commission established by section 16 of chapter 6D. |
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30 | 30 | | 10 SECTION 3. Section 16N of said chapter 6A is hereby repealed. |
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31 | 31 | | 11 SECTION 4. Section 16T of said chapter 6A is hereby repealed. |
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32 | 32 | | 12 SECTION 5. Section 1 of chapter 6D of the General Laws, as so appearing, is hereby |
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33 | 33 | | 13amended by inserting after the definition of “Alternative payment methodologies or methods” |
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34 | 34 | | 14the following definition:- 3 of 119 |
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35 | 35 | | 15 “Benchmark cycle”, a period of 2 consecutive calendar years during which the projected |
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36 | 36 | | 16annualized growth rate in total health care expenditures in the commonwealth is calculated |
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37 | 37 | | 17pursuant to section 9 and monitored pursuant to section 10. |
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38 | 38 | | 18 SECTION 6. Said section 1 of said chapter 6D, as so appearing, is hereby further |
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39 | 39 | | 19amended by inserting after the definition of “Fee-for-service” the following definition:- |
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40 | 40 | | 20 “Financial interest”, when a private equity firm or its corporate affiliate has a direct or |
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41 | 41 | | 21indirect ownership share of, or controlling interest in, or is a holder of significant debt from a |
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42 | 42 | | 22provider or provider organization or the provider or provider organization’s corporate affiliates. |
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43 | 43 | | 23 SECTION 7. Said section 1 of said chapter 6D, as so appearing, is hereby further |
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44 | 44 | | 24amended by striking out the definition of “Health care cost growth benchmark” and inserting in |
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45 | 45 | | 25place thereof the following definition:- |
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46 | 46 | | 26 “Health care cost growth benchmark”, the projected annualized growth rate in total health |
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47 | 47 | | 27care expenditures in the commonwealth during a benchmark cycle, as established in section 9. |
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48 | 48 | | 28 SECTION 8. Said section 1 of said chapter 6D, as so appearing, is hereby further |
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49 | 49 | | 29amended by inserting after the definition of “Health care provider” the following definition:- |
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50 | 50 | | 30 “Health care resource”, any resource, whether personal or institutional in nature and |
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51 | 51 | | 31whether owned or operated by any person, the commonwealth or political subdivision thereof, |
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52 | 52 | | 32the principal purpose of which is to provide, or facilitate the provision of, services for the |
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53 | 53 | | 33prevention, detection, diagnosis or treatment of those physical and mental conditions |
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54 | 54 | | 34experienced by humans which usually are the result of, or result in, disease, injury, deformity or 4 of 119 |
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55 | 55 | | 35pain; provided, that the term “treatment” shall include custodial and rehabilitative care incident |
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56 | 56 | | 36to infirmity, developmental disability or old age. |
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57 | 57 | | 37 SECTION 9. Said section 1 of said chapter 6D, as so appearing, is hereby further |
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58 | 58 | | 38amended by inserting after the definition of “Health care services” the following 2 definitions:- |
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59 | 59 | | 39 “Health disparities”, preventable differences in the burden of disease, injury, violence or |
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60 | 60 | | 40opportunities to achieve optimal health that are experienced by socially disadvantaged |
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61 | 61 | | 41populations. |
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62 | 62 | | 42 “Health equity”, the state in which a health system offers the infrastructure, facilities, |
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63 | 63 | | 43services, geographic coverage, affordability and all other relevant features, conditions and |
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64 | 64 | | 44capabilities to provide every resident of the commonwealth with the opportunity and reasonable |
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65 | 65 | | 45expectation to achieve optimal health and equal access to health care regardless of race, |
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66 | 66 | | 46ethnicity, language, disability, age, gender, gender identity, sexual orientation, social class, |
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67 | 67 | | 47intersections among such communities or identities or socially determined circumstances. |
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68 | 68 | | 48 SECTION 10. Said section 1 of said chapter 6D, as so appearing, is hereby further |
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69 | 69 | | 49amended by inserting after the definition of “Hospital service corporation” the following 2 |
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70 | 70 | | 50definitions:- |
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71 | 71 | | 51 “Management services organization”, a corporation that provides management or |
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72 | 72 | | 52administrative services to a provider or provider organization for compensation. |
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73 | 73 | | 53 “Maximum adjusted debt to adjusted EBITDA ratio”, the highest ratio of total adjusted |
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74 | 74 | | 54debt to adjusted earnings before interest, taxes, depreciation and amortization the commission |
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75 | 75 | | 55determines that a provider or provider organization is permitted to have without becoming 5 of 119 |
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76 | 76 | | 56financially unstable; provided, however, that the commission, in consultation with the center, |
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77 | 77 | | 57shall establish a standard method of calculating and reporting total adjusted debt and adjusted |
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78 | 78 | | 58earnings before interest, taxes, depreciation and amortization; and provided further, that the |
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79 | 79 | | 59methodology and reporting shall include capitalized lease obligations. |
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80 | 80 | | 60 SECTION 11. Said section 1 of said chapter 6D, as so appearing, is hereby further |
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81 | 81 | | 61amended by striking out, in line 189, the words “not include excludes ERISA plans” and |
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82 | 82 | | 62inserting in place thereof the following words:- include self-insured plans to the extent allowed |
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83 | 83 | | 63under the federal Employee Retirement Income Security Act of 1974. |
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84 | 84 | | 64 SECTION 12. Said section 1 of said chapter 6D, as so appearing, is hereby further |
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85 | 85 | | 65amended by inserting after the definition of “Performance penalty” the following 2 definitions:- |
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86 | 86 | | 66 “Pharmaceutical manufacturing company”, an entity engaged in the: (i) production, |
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87 | 87 | | 67preparation, propagation, compounding, conversion or processing of prescription drugs, directly |
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88 | 88 | | 68or indirectly, by extraction from substances of natural origin, independently by means of |
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89 | 89 | | 69chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging, |
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90 | 90 | | 70repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that |
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91 | 91 | | 71pharmaceutical manufacturing company shall not include a wholesale drug distributor licensed |
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92 | 92 | | 72under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said |
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93 | 93 | | 73chapter 112. |
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94 | 94 | | 74 “Pharmacy benefit manager”, a person, business or other entity, however organized, that |
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95 | 95 | | 75directly or through a subsidiary provides pharmacy benefit management services for prescription |
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96 | 96 | | 76drugs and devices on behalf of a health benefit plan sponsor including, but not limited to, a self- |
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97 | 97 | | 77insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit 6 of 119 |
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98 | 98 | | 78management services shall include, but not be limited to: (i) the processing and payment of |
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99 | 99 | | 79claims for prescription drugs; (ii) the performance of drug utilization review; (iii) the processing |
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100 | 100 | | 80of drug prior authorization requests; (iv) pharmacy contracting; (v) the adjudication of appeals or |
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101 | 101 | | 81grievances related to prescription drug coverage contracts; (vi) formulary administration; (vii) |
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102 | 102 | | 82drug benefit design; (viii) mail and specialty drug pharmacy services; (ix) cost containment; (x) |
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103 | 103 | | 83clinical, safety and adherence programs for pharmacy services; and (xi) management of the cost |
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104 | 104 | | 84of covered prescription drugs; provided further, that pharmacy benefit manager shall include a |
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105 | 105 | | 85health benefit plan sponsor that does not contract with a pharmacy benefit manager and manages |
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106 | 106 | | 86its own prescription drug benefits unless specifically exempted by the commission. |
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107 | 107 | | 87 SECTION 13. Said section 1 of said chapter 6D, as so appearing, is hereby further |
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108 | 108 | | 88amended by inserting after the definition of “Primary care provider” the following definition:- |
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109 | 109 | | 89 “Private equity firm”, a publicly traded or non-publicly traded company that collects |
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110 | 110 | | 90capital investments from individuals or entities and purchases, as a parent company or through |
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111 | 111 | | 91another entity that it completely or partially owns or controls, a direct or indirect ownership share |
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112 | 112 | | 92of, or controlling interest in, or otherwise obtains a financial interest in, a provider, provider |
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113 | 113 | | 93organization or management services organization; provided, however, that private equity firm |
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114 | 114 | | 94shall not include venture capital firms exclusively funding startups or other early-stage business. |
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115 | 115 | | 95 SECTION 14. Said section 1 of said chapter 6D, as so appearing, is hereby further |
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116 | 116 | | 96amended by striking out the definition of “Provider organization” and inserting the following 2 |
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117 | 117 | | 97definitions:- |
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118 | 118 | | 98 “Provider organization”, a corporation, partnership, business trust, association or |
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119 | 119 | | 99organized group of persons that is in the business of health care delivery or management, 7 of 119 |
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120 | 120 | | 100whether incorporated or not that represents 1 or more health care providers in contracting with |
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121 | 121 | | 101carriers, third party administrators or public payers for the payments of health care services; |
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122 | 122 | | 102provided, however, that “provider organization” shall include, but not be limited to, physician |
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123 | 123 | | 103organizations, physician-hospital organizations, management services organizations, independent |
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124 | 124 | | 104practice associations, provider networks, accountable care organizations, providers that are |
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125 | 125 | | 105owned or controlled, fully or partially, by for-profit entities including, but not limited to, private |
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126 | 126 | | 106equity firms, and any other organization that contracts with carriers, third party administrators or |
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127 | 127 | | 107public payers for payment for health care services; and provided further, that “provider |
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128 | 128 | | 108organization” shall not include any integrated care network that is owned and directed by long- |
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129 | 129 | | 109term care. |
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130 | 130 | | 110 SECTION 15. Said section 1 of said chapter 6D, as so appearing, is hereby further |
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131 | 131 | | 111amended by inserting after the definition of “Quality measure” the following definition:- |
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132 | 132 | | 112 “Real estate investment trust”, a real estate investment trust as defined in 26 U.S.C. 856. |
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133 | 133 | | 113 SECTION 16. Said section 1 of said chapter 6D, as so appearing, is hereby further |
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134 | 134 | | 114amended by inserting after the definition of “Total health care expenditures” the following 2 |
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135 | 135 | | 115definitions:- |
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136 | 136 | | 116 “Total medical expenses”, the total cost of care for the patient population associated with |
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137 | 137 | | 117a provider organization based on allowed claims for all categories of medical expenses and all |
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138 | 138 | | 118non-claims related payments to providers. |
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139 | 139 | | 119 “Unsafe financial actor”, a private equity firm, private equity firm affiliate or real estate |
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140 | 140 | | 120investment trust that has a financial interest in a provider or provider organization closing, |
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141 | 141 | | 121declaring bankruptcy, or otherwise discontinuing its operations, within 15 years of the private 8 of 119 |
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142 | 142 | | 122equity firm or real estate investment trust’s financial interest in the provider or provider |
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143 | 143 | | 123organization. |
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144 | 144 | | 124 SECTION 17. Section 2 of said chapter 6D, as so appearing, is hereby amended by |
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145 | 145 | | 125striking out subsections (b) and (c) and inserting in place thereof the following 2 subsections:- |
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146 | 146 | | 126 (b)(1) There shall be a board, with duties and powers established by this chapter, which |
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147 | 147 | | 127shall govern the commission. The board shall consist of the following members: the secretary of |
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148 | 148 | | 128administration and finance, ex officio; the secretary of health and human services, ex officio; 7 |
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149 | 149 | | 129members to be appointed by the governor pursuant to paragraph (2), 1 of whom shall serve as |
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150 | 150 | | 130chair; and 4 members to be appointed by the attorney general. Each appointment after the initial |
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151 | 151 | | 131term of appointment shall serve a term of 5 years; provided, however, that a person appointed to |
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152 | 152 | | 132fill a vacancy shall serve for not more than the unexpired term. An appointed member of the |
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153 | 153 | | 133board shall be eligible for reappointment; provided, however, that no appointed member shall |
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154 | 154 | | 134concurrently hold full or part-time employment in the executive branch. The board shall annually |
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155 | 155 | | 135elect 1 of its members to serve as vice-chairperson. Each member of the board shall be a resident |
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156 | 156 | | 136of the commonwealth. A member of the board serving ex officio may appoint a designee under |
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157 | 157 | | 137section 6A of chapter 30; provided further, however, that designee members shall not serve as |
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158 | 158 | | 138chair or vice-chair. |
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159 | 159 | | 139 (2) The person appointed by the governor to serve as chair shall have demonstrated |
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160 | 160 | | 140expertise in health care administration, finance and management at a senior level. The second |
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161 | 161 | | 141person appointed by the governor shall be a registered nurse with expertise in the delivery of care |
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162 | 162 | | 142and development and utilization of innovative treatments in the practice of patient care. The third |
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163 | 163 | | 143person appointed by the governor shall have demonstrated expertise in health plan administration 9 of 119 |
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164 | 164 | | 144and finance. The fourth person appointed by the governor shall have demonstrated expertise in |
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165 | 165 | | 145representing the health care workforce as a leader in a labor organization. The fifth person |
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166 | 166 | | 146appointed by the governor shall have demonstrated expertise in development and pricing for |
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167 | 167 | | 147pharmaceuticals, biotechnology or medical devices. The sixth person appointed by the governor |
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168 | 168 | | 148shall be a primary care physician. The seventh person appointed by the governor shall have |
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169 | 169 | | 149demonstrated expertise as a purchaser of health insurance representing business management or |
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170 | 170 | | 150health benefits administration. The first person appointed by the attorney general shall have |
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171 | 171 | | 151demonstrated expertise in hospitals or hospital health systems administration, finance or |
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172 | 172 | | 152management. The second person appointed by the attorney general shall have demonstrated |
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173 | 173 | | 153expertise in health care consumer advocacy. The third person appointed by the attorney general |
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174 | 174 | | 154shall have expertise in behavioral health, substance use disorder, mental health services and |
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175 | 175 | | 155mental health reimbursement systems. The fourth person appointed by the attorney general shall |
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176 | 176 | | 156be a health economist. |
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177 | 177 | | 157 (c) Seven members of the board shall constitute a quorum, and the affirmative vote of 6 |
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178 | 178 | | 158members of the board shall be necessary and sufficient for any action taken by the board. No |
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179 | 179 | | 159vacancy in the membership of the board shall impair the right of a quorum to exercise all the |
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180 | 180 | | 160rights and duties of the commission. The appointed members of the board shall receive a stipend |
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181 | 181 | | 161in an amount not more than 10 per cent of the salary of the secretary of administration and |
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182 | 182 | | 162finance under section 4 of chapter 7; provided, however, that the chairperson shall receive a |
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183 | 183 | | 163stipend in an amount not more than 12 per cent of the salary of the secretary; and provided |
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184 | 184 | | 164further, that ex officio members and their designees shall not receive a stipend for their service as |
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185 | 185 | | 165board members. Appointed members of the board shall be special state employees subject to |
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186 | 186 | | 166chapter 268A. An appointed member of the board shall not be employed by, a consultant to, a 10 of 119 |
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187 | 187 | | 167member of the board of directors of or otherwise be a representative of a health care entity, |
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188 | 188 | | 168pharmaceutical manufacturer or pharmacy benefit manager while serving on the board. |
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189 | 189 | | 169 SECTION 18. Said chapter 6D is hereby further amended by inserting after section 3 the |
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190 | 190 | | 170following section:- |
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191 | 191 | | 171 Section 3A. (a) There shall be within the commission an office for pharmaceutical policy |
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192 | 192 | | 172and analysis. The office shall: (i) issue reports including, but not limited to, an annual report |
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193 | 193 | | 173pursuant to subsection (b) and analyses of: (A) pharmaceutical spending in the commonwealth; |
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194 | 194 | | 174the affordability of and access to pharmaceutical drugs; (B) the potential innovation of high |
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195 | 195 | | 175value drugs and orphan drugs; and (C) the impacts of these issues on racially and ethnically |
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196 | 196 | | 176diverse populations and individuals with disabilities; (ii) analyze pharmaceutical data collected |
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197 | 197 | | 177by agencies of the commonwealth including, but not limited to, pharmaceutical data collected by |
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198 | 198 | | 178the center pursuant to sections 8 to 10, inclusive, of chapter 12C and pharmaceutical data |
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199 | 199 | | 179available through public and proprietary sources; provided, however, that the commission may |
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200 | 200 | | 180solicit additional data and information directly from manufacturers, pharmacy benefit managers |
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201 | 201 | | 181and payers to the extent necessary to perform the duties set forth in this section, including, but |
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202 | 202 | | 182not limited to, conducting an annual survey of payers on pharmaceutical access and plan design; |
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203 | 203 | | 183provided, however, that confidential data shall not be a public record and shall be exempt from |
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204 | 204 | | 184disclosure pursuant to clause Twenty-sixth of section 7 of chapter 4 and section 10 of chapter 66; |
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205 | 205 | | 185(iii) assess the value and pricing of pharmaceutical drugs used in the commonwealth including, |
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206 | 206 | | 186but not limited to, reviewing disclosures submitted pursuant to section 8A; and (iv) advise other |
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207 | 207 | | 187state agencies and entities including, but not limited to, the executive office of health and human |
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208 | 208 | | 188services, the office of Medicaid, the division of insurance, the group insurance commission, the |
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209 | 209 | | 189commonwealth health insurance connector authority, the department of corrections, the 11 of 119 |
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210 | 210 | | 190Massachusetts Life Sciences Center and the joint committee on health care financing on actions, |
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211 | 211 | | 191including any proposed legislation, that may improve the value and pricing of pharmaceutical |
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212 | 212 | | 192drugs in the commonwealth. |
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213 | 213 | | 193 (b) The commission shall compile an annual report concerning trends and underlying |
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214 | 214 | | 194factors for pharmaceutical drug spending including, but not limited to, analysis of: (i) prices and |
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215 | 215 | | 195utilization; (ii) drugs or categories of drugs with the highest impact on spending; (iii) trends in |
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216 | 216 | | 196patient out-of-pocket spending; and (iv) any recommendations for strategies to reduce |
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217 | 217 | | 197pharmaceutical spending growth, promote affordability and enhance pharmaceutical access. The |
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218 | 218 | | 198report shall be based on: (A) the commission’s analysis of information provided at the annual |
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219 | 219 | | 199health care cost trends hearings by providers, provider organizations and insurers; (B) data |
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220 | 220 | | 200collected by the center for health information and analysis under sections 8 to10, inclusive, of |
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221 | 221 | | 201chapter 12C; and (C) any other information the commission considers necessary to fulfill its |
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222 | 222 | | 202duties under this section, as further defined in regulations promulgated by the commission. |
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223 | 223 | | 203Annually, not later than December 31, the commission shall submit the report to the chairs of the |
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224 | 224 | | 204house and senate committees on ways and means and the chairs of the joint committee on health |
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225 | 225 | | 205care financing and shall publish and make the report available to the public. |
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226 | 226 | | 206 SECTION 19. Said chapter 6D is hereby further amended by striking out section 4, as |
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227 | 227 | | 207appearing in the 2022 Official Edition, and inserting in place thereof the following section:- |
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228 | 228 | | 208 Section 4. There shall be an advisory council to the commission. The council shall advise |
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229 | 229 | | 209on the overall operation and policy of the commission. The commission shall convene the |
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230 | 230 | | 210council quarterly or more frequently as requested by the commission. Members of the board of |
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231 | 231 | | 211the health policy commission shall convene and consult with advisory council members on 12 of 119 |
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232 | 232 | | 212issues brought before the commission and shall present the views of advisory council members |
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233 | 233 | | 213in board meetings. The council shall be appointed by the executive director and reflect a broad |
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234 | 234 | | 214distribution of diverse perspectives on the health care system, including, but not limited to, |
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235 | 235 | | 215health care professionals, educational institutions, consumer representatives, purchasers of health |
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236 | 236 | | 216insurance representing business management or health benefits administration, medical device |
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237 | 237 | | 217manufacturers, representatives of the biotechnology industry, pharmaceutical manufacturers, |
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238 | 238 | | 218providers, provider organizations, hospitals, community health centers, labor organizations and |
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239 | 239 | | 219public and private payers. |
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240 | 240 | | 220 SECTION 20. Section 5 of said chapter 6D, as so appearing, is hereby amended by |
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241 | 241 | | 221inserting after the word “growth”, in line 3, the following words:- and affordability. |
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242 | 242 | | 222 SECTION 21. Said section 5 of said chapter 6D, as so appearing, is hereby further |
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243 | 243 | | 223amended by striking out, in line 10, the words “and (vii)” and inserting in place thereof the |
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244 | 244 | | 224following words:- ; (vii) monitor pharmaceutical spending and pricing and patient access to |
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245 | 245 | | 225pharmaceuticals; and (viii). |
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246 | 246 | | 226 SECTION 22. The first paragraph of section 6 of said chapter 6D, as so appearing, is |
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247 | 247 | | 227hereby amended by adding the following sentence:- |
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248 | 248 | | 228 Each pharmaceutical manufacturing company and pharmacy benefit manager shall pay to |
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249 | 249 | | 229the commonwealth an amount for the estimated expenses of the center and for the other purposes |
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250 | 250 | | 230described in this chapter. |
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251 | 251 | | 231 SECTION 23. Said section 6 of said chapter 6D, as so appearing, is hereby further |
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252 | 252 | | 232amended by striking out, in lines 5 and 36, the figure “33”, each time it appears, and inserting in |
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253 | 253 | | 233place thereof, in each instance, the following figure:- 25. 13 of 119 |
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254 | 254 | | 234 SECTION 24. Said section 6 of said chapter 6D, as so appearing, is hereby further |
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255 | 255 | | 235amended by adding the following 3 paragraphs:- |
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256 | 256 | | 236 To the maximum extent permissible under federal law, provided that such assessment |
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257 | 257 | | 237will not result in any reduction of federal financial participation in Medicaid, the assessed |
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258 | 258 | | 238amount for pharmaceutical manufacturing companies shall be not less than 25 per cent of the |
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259 | 259 | | 239amount appropriated by the general court for the expenses of the commission less amounts |
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260 | 260 | | 240collected from: (i) filing fees; (ii) fees and charges generated by the commission's publication or |
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261 | 261 | | 241dissemination of reports and information; and (iii) federal matching revenues received for said |
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262 | 262 | | 242expenses or received retroactively for expenses of predecessor agencies. Pharmaceutical |
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263 | 263 | | 243manufacturing companies shall pay such assessed amount multiplied by the ratio of the |
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264 | 264 | | 244pharmaceutical manufacturing company’s gross sales of outpatient prescription drugs dispensed |
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265 | 265 | | 245in the commonwealth or similar measure determined by the commission consistent with |
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266 | 266 | | 246applicable federal requirements. |
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267 | 267 | | 247 To fund the operations of the commonwealth’s licensure of pharmacy benefit managers |
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268 | 268 | | 248and to the maximum extent permissible under federal law; provided, however, that such |
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269 | 269 | | 249assessment will not result in any reduction of federal financial participation in Medicaid, the |
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270 | 270 | | 250assessed amount for pharmacy benefit managers shall be not less than 25 per cent of the amount |
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271 | 271 | | 251appropriated by the general court for the expenses of the commission less amounts collected |
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272 | 272 | | 252from: (i) filing fees; (ii) fees and charges generated by the commission's publication or |
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273 | 273 | | 253dissemination of reports and information; and (iii) federal matching revenues received for said |
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274 | 274 | | 254expenses or received retroactively for expenses of predecessor agencies. Pharmacy benefit |
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275 | 275 | | 255managers shall pay such assessed amount multiplied by the ratio of the pharmacy benefit |
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276 | 276 | | 256manager’s gross revenue related to outpatient prescription drugs dispensed in the commonwealth 14 of 119 |
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277 | 277 | | 257or similar measure determined by the commission consistent with applicable federal |
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278 | 278 | | 258requirements. In no event shall this assessment, when combined with an assessment of pharmacy |
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279 | 279 | | 259benefit managers pursuant to section 7 of chapter 12C and a pharmacy benefit manager licensing |
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280 | 280 | | 260fee pursuant to section 2 of chapter 176Y, exceed the commonwealth’s estimated expense in |
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281 | 281 | | 261operating the pharmacy benefit manager licensure program. |
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282 | 282 | | 262 Each pharmaceutical manufacturing company and each pharmacy benefit manager shall |
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283 | 283 | | 263make a preliminary payment to the commission annually on October 1 in an amount equal to 1/2 |
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284 | 284 | | 264of the initial year’s total assessment and, for subsequent years, in an amount equal to 1/2 of the |
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285 | 285 | | 265previous year's total assessment. Thereafter, each pharmaceutical manufacturing company and |
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286 | 286 | | 266each pharmacy benefit manager shall pay, within 30 days of receiving notice from the |
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287 | 287 | | 267commission, the balance of the total assessment for the current year as determined by the |
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288 | 288 | | 268commission. |
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289 | 289 | | 269 SECTION 25. Section 7 of said chapter 6D, as so appearing, is hereby amended by |
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290 | 290 | | 270striking out, in line 35, the words “and (vi)” and inserting in place thereof the following words:- |
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291 | 291 | | 271(vi) advance health equity; and (vii). |
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292 | 292 | | 272 SECTION 26. Said chapter 6D is hereby further amended by striking out section 8, as so |
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293 | 293 | | 273appearing, and inserting in place thereof the following section:- |
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294 | 294 | | 274 Section 8. (a) Not later than October 1 of every year, the commission shall hold public |
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295 | 295 | | 275hearings based on the report submitted by the center pursuant to section 16 of chapter 12C |
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296 | 296 | | 276comparing: (i) the average of the annual growth in total health care expenditures during each |
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297 | 297 | | 277year of the most recently concluded benchmark cycle to the health care cost growth benchmark |
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298 | 298 | | 278for that benchmark cycle; and (ii) the growth in the affordability index pursuant to said section 15 of 119 |
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299 | 299 | | 27916 of said chapter 12C to the affordability benchmark. At said hearings, the commission shall |
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300 | 300 | | 280examine the costs, prices and cost trends of health care providers, provider organizations, private |
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301 | 301 | | 281and public health care payers, pharmaceutical manufacturing companies and pharmacy benefit |
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302 | 302 | | 282managers and any relevant impact of private equity firms, real estate investment trusts and |
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303 | 303 | | 283management services organizations on such costs, prices and cost trends, with particular |
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304 | 304 | | 284attention to factors that contribute to cost growth within the commonwealth's health care system |
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305 | 305 | | 285and trends in annual behavioral health expenditures. |
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306 | 306 | | 286 (b) The attorney general may intervene in such hearings. |
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307 | 307 | | 287 (c) Public notice of any hearing shall be provided not less than 60 days in advance. |
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308 | 308 | | 288 (d) The commission shall identify as witnesses for the public hearing a representative |
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309 | 309 | | 289sample of providers, provider organizations, payers, private equity firms, real estate investment |
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310 | 310 | | 290trusts, management services organizations, pharmaceutical manufacturing companies, pharmacy |
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311 | 311 | | 291benefit managers and others, including: (i) not less than 3 academic medical centers, including |
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312 | 312 | | 292the 2 acute hospitals with the highest level of net patient service revenue; (ii) not less than 3 |
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313 | 313 | | 293disproportionate share hospitals, including the 2 hospitals whose largest per cent of gross patient |
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314 | 314 | | 294service revenue is attributable to Title XVIII and XIX of the Social Security Act or other |
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315 | 315 | | 295governmental payers; (iii) community hospitals from not less than l 3 separate regions of the |
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316 | 316 | | 296commonwealth; (iv) freestanding ambulatory surgical centers from not less than 3 separate |
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317 | 317 | | 297regions of the commonwealth; (v) community health centers from at not less than 3 separate |
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318 | 318 | | 298regions of the commonwealth; (vi) the 5 commercial carriers with the highest enrollments in the |
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319 | 319 | | 299commonwealth; (vii) any managed care organization that provides health benefits under Title |
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320 | 320 | | 300XIX of the Social Security Act ; (viii) the group insurance commission; (ix) not less than 3 16 of 119 |
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321 | 321 | | 301municipalities that have adopted chapter 32B; (x) not less than 4 provider organizations which |
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322 | 322 | | 302shall be from diverse geographic regions of the commonwealth, not less than 2 of which shall be |
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323 | 323 | | 303certified as accountable care organizations and 1 of which shall be certified as a model ACO; (xi) |
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324 | 324 | | 304at least 1 private equity firms, real estate investment trust or management services organization |
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325 | 325 | | 305associated with a provider or provider organization; (xii) the assistant secretary for MassHealth; |
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326 | 326 | | 306(xiii) not less than 3 representatives of pharmaceutical manufacturing companies doing business |
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327 | 327 | | 307in the commonwealth or trade groups thereof; (xiv) 1 pharmacy benefit manager or trade groups |
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328 | 328 | | 308thereof; and (xv) any witness identified by the attorney general or the center. |
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329 | 329 | | 309 (e) Witnesses shall provide testimony under oath and subject to examination and cross |
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330 | 330 | | 310examination by the commission, the executive director of the center and the attorney general at |
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331 | 331 | | 311the public hearing in a manner and form to be determined by the commission, including, but not |
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332 | 332 | | 312limited to: (i) in the case of providers and provider organizations, testimony concerning payment |
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333 | 333 | | 313systems, care delivery models, payer mix, cost structures, administrative and labor costs, capital |
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334 | 334 | | 314and technology cost, adequacy of public payer reimbursement levels, reserve levels, utilization |
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335 | 335 | | 315trends, relative price, quality improvement and care-coordination strategies, investments in |
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336 | 336 | | 316health information technology, the relation of private payer reimbursement levels to public payer |
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337 | 337 | | 317reimbursements for similar services, efforts to improve the efficiency of the delivery system, |
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338 | 338 | | 318efforts to reduce the inappropriate or duplicative use of technology and the impact of price |
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339 | 339 | | 319transparency on prices; (ii) in the case of private and public payers, testimony concerning factors |
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340 | 340 | | 320underlying premium cost and rate increases, the relation of reserves to premium costs, efforts by |
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341 | 341 | | 321the payer to reduce the use of fee-for-service payment mechanisms, the payer's efforts to develop |
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342 | 342 | | 322benefit design, network design and payment policies that enhance product affordability and |
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343 | 343 | | 323encourage efficient use of health resources and technology including utilization of alternative 17 of 119 |
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344 | 344 | | 324payment methodologies, efforts by the payer to increase consumer access to health care |
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345 | 345 | | 325information, efforts by the payer to promote the standardization of administrative practices, the |
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346 | 346 | | 326impact of price transparency on prices and any other matters as determined by the commission; |
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347 | 347 | | 327(iii) in the case of the assistant secretary for MassHealth, testimony concerning the structure, |
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348 | 348 | | 328benefits, eligibility, caseload and financing of MassHealth and other Medicaid programs |
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349 | 349 | | 329administered by the office of Medicaid or in partnership with other state and federal agencies and |
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350 | 350 | | 330the agency’s activities to align or redesign said programs in order to encourage the development |
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351 | 351 | | 331of more integrated and efficient health care delivery systems; (iv) in the case of private equity |
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352 | 352 | | 332firms, real estate investment trusts or management services organization, testimony concerning |
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353 | 353 | | 333changes to patient access to health care services or facilities, health outcomes, prices charged to |
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354 | 354 | | 334insurers and patients, staffing levels, clinical workflow, financial stability and ownership |
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355 | 355 | | 335structure as the result of an acquisition of a provider or provider organization, the amount of debt |
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356 | 356 | | 336and equity leveraged in an acquisition of a provider or provider organization, additional debt |
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357 | 357 | | 337taken on by a provider or provider organization after an acquisition, dividends paid out to |
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358 | 358 | | 338investors, changes to real estate ownership and any leaseback agreements and management of |
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359 | 359 | | 339clinical assets and any other matters as determined by the commission; and (v) in the case of |
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360 | 360 | | 340pharmacy benefit managers and pharmaceutical manufacturing companies, testimony concerning |
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361 | 361 | | 341factors underlying prescription drug costs and price changes including, but not limited to, the |
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362 | 362 | | 342initial prices of drugs coming to market and subsequent price changes, changes in industry profit |
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363 | 363 | | 343levels, marketing expenses, reverse payment patent settlements, impacts of manufacturer rebates, |
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364 | 364 | | 344discounts and other price concessions on net pricing, availability of alternative drugs or |
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365 | 365 | | 345treatments, corporate ownership organizational structure and any other matters as determined by |
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366 | 366 | | 346the commission. The commission shall solicit testimony from a payer which has been identified 18 of 119 |
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367 | 367 | | 347by the center's annual report under subsection (a) of section 16 of chapter 12C as: (A) paying |
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368 | 368 | | 348providers more than 10 per cent above or more than 10 per cent below the average relative price; |
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369 | 369 | | 349or (B) entering into alternative payment contracts that vary by more than 10 per cent. A payer |
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370 | 370 | | 350identified by the center's report shall explain the extent of price variation between the payer's |
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371 | 371 | | 351participating providers and describe any efforts to reduce such price variation. |
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372 | 372 | | 352 (f) If the center's annual report pursuant to subsection (a) of section 16 of chapter 12C |
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373 | 373 | | 353finds that the average of the annual percentage changes in total health care expenditures during a |
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374 | 374 | | 354benchmark cycle exceeded the health care cost growth benchmark for that benchmark cycle or |
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375 | 375 | | 355the percentage change in the affordability index exceeded the affordability benchmark, the |
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376 | 376 | | 356commission may identify additional witnesses for the public hearing. Witnesses shall provide |
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377 | 377 | | 357testimony subject to examination and cross examination by the commission, the executive |
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378 | 378 | | 358director of the center and attorney general at the public hearing in a manner and form to be |
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379 | 379 | | 359determined by the commission, including, but not limited to: (i) testimony concerning |
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380 | 380 | | 360unanticipated events that may have impacted the total health care cost expenditures and |
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381 | 381 | | 361affordability, including, but not limited to, a public health crisis such as an outbreak of a disease, |
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382 | 382 | | 362a public safety event or a natural disaster; (ii) testimony concerning trends in patient acuity, |
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383 | 383 | | 363complexity or utilization of services; (iii) testimony concerning trends in input cost structures, |
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384 | 384 | | 364including, but not limited to, the introduction of new pharmaceuticals, medical devices and other |
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385 | 385 | | 365health technologies; (iv) testimony concerning the cost of providing certain specialty services, |
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386 | 386 | | 366including, but not limited to, the provision of health care to children, cancer-related health care |
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387 | 387 | | 367and medical education; (v) testimony related to unanticipated administrative costs for carriers, |
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388 | 388 | | 368including, but not limited to, costs related to information technology, administrative |
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389 | 389 | | 369simplification efforts, labor costs and transparency efforts; (vi) testimony related to costs due the 19 of 119 |
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390 | 390 | | 370implementation of state or federal legislation or government regulation; (vii) testimony related to |
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391 | 391 | | 371premiums by market segment and community, plan and benefit design and cost sharing, |
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392 | 392 | | 372including deductibles and co-pays; and (viii) any other factors that may have led to excessive |
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393 | 393 | | 373health care cost growth. |
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394 | 394 | | 374 (g) The commission shall annually compile a report for the most recently concluded |
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395 | 395 | | 375benchmark cycle concerning spending trends, including primary care and behavioral health |
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396 | 396 | | 376expenditures, affordability and the underlying factors influencing said spending trends. The |
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397 | 397 | | 377report shall be based on the commission’s analysis of information provided at the hearings by |
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398 | 398 | | 378witnesses, providers, provider organizations, payers, private equity firms, real estate investment |
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399 | 399 | | 379trusts, management services organizations, pharmaceutical manufacturing companies and |
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400 | 400 | | 380pharmacy benefit managers, registration data collected pursuant to section 11, data collected or |
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401 | 401 | | 381analyzed by the center pursuant to sections 8 to 10A, inclusive, of chapter 12C and any other |
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402 | 402 | | 382available information that the commission considers necessary to fulfill its duties under this |
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403 | 403 | | 383section, as further defined in regulations promulgated by the commission. To the extent |
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404 | 404 | | 384practicable, the report shall not contain any data that is likely to compromise the financial, |
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405 | 405 | | 385competitive or proprietary nature of the information. The report shall be submitted to the chairs |
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406 | 406 | | 386of the house and senate committees on ways and means and the chairs of the joint committee on |
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407 | 407 | | 387health care financing and shall be published and made available to the public annually, not later |
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408 | 408 | | 388than December 31, of each year. The report shall include recommendations for strategies to |
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409 | 409 | | 389increase the efficiency of the health care system and promote affordability for individuals and |
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410 | 410 | | 390families and analysis of specific spending trends that may impede the commonwealth’s ability to |
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411 | 411 | | 391meet the health care cost growth benchmark, together with any drafts of legislation language |
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412 | 412 | | 392necessary to implement said recommendations. 20 of 119 |
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413 | 413 | | 393 SECTION 27. Said chapter 6D is hereby further amended by striking out sections 9 and |
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414 | 414 | | 39410, as so appearing, and inserting in place thereof the following 3 sections:- |
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415 | 415 | | 395 Section 9. (a) Not later than April 15 of every year, the board shall establish the health |
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416 | 416 | | 396care cost growth benchmark for a benchmark cycle consisting of the 2 calendar years beginning |
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417 | 417 | | 397after the year in which the April 15 date occurs. |
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418 | 418 | | 398 (b) The health care cost growth benchmark shall be equal to the average of the growth |
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419 | 419 | | 399rate of potential gross state product established under section 7H½ of chapter 29 for each of the 2 |
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420 | 420 | | 400calendar years that comprise the benchmark cycle. The commission shall establish procedures to |
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421 | 421 | | 401prominently publish the health care cost growth benchmark on the commission’s website. |
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422 | 422 | | 402 (c) For all benchmark cycles through the cycle containing the calendar years 2039 and |
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423 | 423 | | 4032040, if the commission determines that an adjustment in the health care cost growth benchmark |
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424 | 424 | | 404is reasonably warranted, having first considered any testimony at a public hearing as required |
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425 | 425 | | 405under subsection (d), the board of the commission may recommend a modification of the health |
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426 | 426 | | 406care cost growth benchmark, in any amount as determined by the commission. The board shall |
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427 | 427 | | 407submit notice of its recommendation for any modification to the joint committee on health care |
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428 | 428 | | 408financing. Within 30 days of such filing, the joint committee may hold a public hearing on the |
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429 | 429 | | 409board's proposed modification to the health care cost growth benchmark. Within 30 days of the |
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430 | 430 | | 410public hearing, the joint committee may report its findings and proposed legislation, including its |
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431 | 431 | | 411recommendation on whether to affirm or reject the boards’ recommendation, to the general court |
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432 | 432 | | 412and provide a copy of its findings and proposed legislation to the board. |
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433 | 433 | | 413 (d) Prior to making any recommended modification to the health care cost growth |
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434 | 434 | | 414benchmark under subsection (c), the board shall hold a public hearing on any such recommended 21 of 119 |
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435 | 435 | | 415modification. The public hearing shall be based on the report submitted by the center pursuant to |
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436 | 436 | | 416section 16 of chapter 12C comparing the average of the annual growth in total health care |
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437 | 437 | | 417expenditures during each year of the most recently concluded benchmark cycle to the health care |
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438 | 438 | | 418cost growth benchmark, any other data provided by the center and such other pertinent |
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439 | 439 | | 419information or data as may be available to the board. The hearing shall examine the costs, prices |
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440 | 440 | | 420and cost trends of health care provider, provider organization and private and public health care |
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441 | 441 | | 421payer and any relevant impact of private equity firms, real estate investment trusts, management |
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442 | 442 | | 422services organizations, pharmaceutical manufacturing companies and pharmacy benefit |
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443 | 443 | | 423managers on such costs, prices and cost trends, with particular attention to factors that contribute |
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444 | 444 | | 424to cost growth within the commonwealth’s health care system and whether, based on the |
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445 | 445 | | 425testimony, information and data presented at the hearing, a modification in the health care cost |
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446 | 446 | | 426growth benchmark is appropriate. The commission shall provide public notice of such hearing |
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447 | 447 | | 427not less than 45 days prior to the date of the hearing, including notice to the joint committee on |
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448 | 448 | | 428health care financing. The joint committee on health care financing may participate in the |
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449 | 449 | | 429hearing. The commission shall identify as witnesses for the public hearing a representative |
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450 | 450 | | 430sample of providers, provider organizations, payers, private equity firms, real estate investment |
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451 | 451 | | 431trusts, management services organizations, pharmaceutical manufacturing companies, pharmacy |
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452 | 452 | | 432benefit managers and such other interested parties as the commission may determine. Any other |
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453 | 453 | | 433interested parties may testify at the hearing. |
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454 | 454 | | 434 (e) Any recommendation of the commission to modify the health care cost growth |
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455 | 455 | | 435benchmark under subsection (c) of this section shall be approved by a two-thirds vote of the |
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456 | 456 | | 436board. 22 of 119 |
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457 | 457 | | 437 Section 9A. Not later than April 15 of every year, the board shall establish a health care |
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458 | 458 | | 438affordability benchmark for the following calendar year. The commission shall establish |
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459 | 459 | | 439procedures to prominently publish the annual affordability benchmark on the commission's |
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460 | 460 | | 440website. |
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461 | 461 | | 441 Section 10. (a) For the purpose of this section, “Health care entity” shall mean any health |
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462 | 462 | | 442care entity identified by the center pursuant to section 18 of chapter 12C. |
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463 | 463 | | 443 (b) The commission shall provide notice to a health care entity that the commission may |
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464 | 464 | | 444analyze the health care spending performance of such health care entity and that such health care |
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465 | 465 | | 445entity shall perform certain actions as provided in subsection (c); provided, however, that at the |
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466 | 466 | | 446discretion of the commission, the commission may publicly identify the identities and |
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467 | 467 | | 447performance results of such health care entity. |
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468 | 468 | | 448 (c) The commission may require a performance improvement plan to be filed with the |
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469 | 469 | | 449commission for a health care entity that is identified by the center under section 18 of chapter |
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470 | 470 | | 45012C. |
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471 | 471 | | 451 (d) In addition to the notice provided under subsection (b), the commission shall provide |
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472 | 472 | | 452written notice to a health care entity that it determines must file a performance improvement |
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473 | 473 | | 453plan. Within 45 days of receipt of such written notice, the health care entity shall either: |
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474 | 474 | | 454 (1) file a performance improvement plan with the commission; or |
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475 | 475 | | 455 (2) file an application with the commission to waive or extend the requirement to file a |
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476 | 476 | | 456performance improvement plan. 23 of 119 |
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477 | 477 | | 457 (e) The health care entity may file documentation or supporting evidence with the |
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478 | 478 | | 458commission to support the health care entity’s application to waive or extend the requirement to |
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479 | 479 | | 459file a performance improvement plan. The commission shall require the health care entity to |
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480 | 480 | | 460submit any other relevant information it deems necessary in considering the waiver or extension |
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481 | 481 | | 461application; provided, however, that such information shall be made public at the discretion of |
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482 | 482 | | 462the commission. |
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483 | 483 | | 463 (f) The commission may waive or delay the requirement for a health care entity to file a |
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484 | 484 | | 464performance improvement plan in response to a waiver or extension request filed under |
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485 | 485 | | 465subsection (d) in light of all information received from the health care entity, based on a |
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486 | 486 | | 466consideration of the following factors: |
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487 | 487 | | 467 (1) the spending, price and utilization trends of the health care entity over time, |
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488 | 488 | | 468independently and as compared to similar entities, and any demonstrated improvement to reduce |
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489 | 489 | | 469spending or total medical expenses; |
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490 | 490 | | 470 (2) any ongoing strategies or investments that the health care entity is implementing to |
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491 | 491 | | 471improve future long-term efficiency and reduce spending growth; |
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492 | 492 | | 472 (3) whether the factors that led to increased spending for the health care entity can |
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493 | 493 | | 473reasonably be considered to be unanticipated and outside of the control of the entity. Such factors |
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494 | 494 | | 474may include, but shall not be limited to, age and other health status adjusted factors and other |
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495 | 495 | | 475cost inputs such as pharmaceutical expenses, medical device expenses and labor costs; |
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496 | 496 | | 476 (4) the overall financial condition of the health care entity; 24 of 119 |
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497 | 497 | | 477 (5) a significant difference between the growth rate of potential gross state product and |
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498 | 498 | | 478the growth rate of actual gross state product, as determined under section 7H½ of chapter 29; and |
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499 | 499 | | 479 (6) any other factors the commission considers relevant. |
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500 | 500 | | 480 (g) If the commission declines to waive or extend the requirement for the health care |
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501 | 501 | | 481entity to file a performance improvement plan, the commission shall provide written notice to the |
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502 | 502 | | 482health care entity that its application for a waiver or extension was denied and the health care |
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503 | 503 | | 483entity shall file a performance improvement plan. |
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504 | 504 | | 484 (h) A health care entity shall file a performance improvement plan: (A) within 45 days of |
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505 | 505 | | 485receipt of a notice under subsection (d); (B) if the health care entity has requested a waiver or |
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506 | 506 | | 486extension, within 45 days of receipt of a notice that such waiver or extension has been denied; or |
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507 | 507 | | 487(C) if the health care entity is granted an extension, on the date given on such extension. The |
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508 | 508 | | 488performance improvement plan shall identify the causes of the entity's excessive spending, and |
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509 | 509 | | 489shall include, but not be limited to, specific strategies, adjustments and action steps the entity |
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510 | 510 | | 490proposes to implement to improve spending performance. The proposed performance |
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511 | 511 | | 491improvement plan shall include specific identifiable and measurable expected outcomes and a |
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512 | 512 | | 492timetable for implementation. The timetable for a performance improvement plan shall not |
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513 | 513 | | 493exceed 18 months. |
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514 | 514 | | 494 (i) The commission shall approve any performance improvement plan that it determines |
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515 | 515 | | 495is reasonably likely to address the underlying cause of the health care entity’s excessive spending |
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516 | 516 | | 496and has a reasonable expectation for successful implementation. 25 of 119 |
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517 | 517 | | 497 (j) If the board determines that the performance improvement plan is unacceptable or |
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518 | 518 | | 498incomplete, the commission may provide consultation on the criteria that have not been met and |
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519 | 519 | | 499may allow an additional time period of not more than 30 calendar days, for resubmission. |
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520 | 520 | | 500 (k) Upon approval of the proposed performance improvement plan, the commission shall |
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521 | 521 | | 501notify the health care entity to begin implementation of the performance improvement plan. |
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522 | 522 | | 502Public notice shall be provided by the commission on its website, identifying that the health care |
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523 | 523 | | 503entity is implementing a performance improvement plan. Health care entities implementing an |
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524 | 524 | | 504approved performance improvement plan shall be subject to additional reporting requirements |
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525 | 525 | | 505and compliance monitoring, as determined by the commission. The commission shall assist the |
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526 | 526 | | 506health care entity with the successful implementation of the performance improvement plan. |
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527 | 527 | | 507 (l) Health care entities subject to a performance improvement plan shall, in good faith, |
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528 | 528 | | 508work to implement such plan and may file amendments to the performance improvement plan at |
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529 | 529 | | 509any point during the implementation of the performance improvement plan, subject to approval |
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530 | 530 | | 510of the commission. |
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531 | 531 | | 511 (m) At the conclusion of the timetable established in the performance improvement plan, |
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532 | 532 | | 512the health care entity shall report to the commission regarding the outcome of the performance |
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533 | 533 | | 513improvement plan. If the commission finds that the performance improvement plan was |
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534 | 534 | | 514unsuccessful, the commission shall either: (i) extend the implementation timetable of the existing |
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535 | 535 | | 515performance improvement plan; (ii) approve amendments to the performance improvement plan |
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536 | 536 | | 516as proposed by the health care entity; (iii) require the health care entity to submit a new |
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537 | 537 | | 517performance improvement plan under subsection (c), including requiring specific elements for 26 of 119 |
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538 | 538 | | 518approval; or (iv) waive or delay the requirement to file any additional performance improvement |
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539 | 539 | | 519plans. |
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540 | 540 | | 520 (n) Upon the successful completion of the performance improvement plan, the identity of |
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541 | 541 | | 521the health care entity shall be removed from the list of entities currently implementing a |
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542 | 542 | | 522performance improvement plan on the commission’s website. |
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543 | 543 | | 523 (o) The commission may submit a recommendation for proposed legislation to the joint |
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544 | 544 | | 524committee on health care financing if the commission determines that further legislative |
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545 | 545 | | 525authority is needed to achieve the commonwealth’s health care quality and spending |
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546 | 546 | | 526sustainability objectives, assist health care entities with the implementation of performance |
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547 | 547 | | 527improvement plans or otherwise ensure compliance with the provisions of this section. |
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548 | 548 | | 528 (p)(1) If the commission determines that a health care entity has: (i) willfully neglected to |
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549 | 549 | | 529file a performance improvement plan with the commission within 45 days as required under |
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550 | 550 | | 530subsection (d); (ii) failed to file an acceptable performance improvement plan in good faith with |
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551 | 551 | | 531the commission; (iii) failed to implement the performance improvement plan in good faith; or |
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552 | 552 | | 532(iv) knowingly failed to provide or falsified information required by this section to the |
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553 | 553 | | 533commission, the commission may: (A) assess a civil penalty to the health care entity of not more |
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554 | 554 | | 534than $500,000 for a first violation, not more than $750,000 for a second violation and not more |
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555 | 555 | | 535than $1,000,000 for a third or subsequent violation; provided, however, that a civil penalty |
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556 | 556 | | 536assessed pursuant to one of the above clauses shall be a first offense if a previously assessed |
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557 | 557 | | 537penalty was assessed pursuant to a different clause; (B) stay consideration of any material change |
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558 | 558 | | 538notice submitted under section 13 of this chapter by the health care entity or any affiliates until |
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559 | 559 | | 539the commission determines that the health care entity is in compliance with this section; and (C) 27 of 119 |
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560 | 560 | | 540notify the department of public health that the health care entity, if applying for a notice of |
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561 | 561 | | 541determination of need, is not in compliance with this section. A civil penalty assessed under this |
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562 | 562 | | 542subsection shall be deposited into the Healthcare Payment Reform Fund established under |
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563 | 563 | | 543section 100 of chapter 194 of the acts of 2011. Except as otherwise expressly authorized under |
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564 | 564 | | 544this section, the commission shall seek to promote compliance with this section and shall only |
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565 | 565 | | 545impose a civil penalty as a last resort. |
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566 | 566 | | 546 (2) In lieu of requiring a performance improvement plan pursuant to this section, the |
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567 | 567 | | 547commission may assess a civil penalty on a health care entity identified by the center pursuant to |
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568 | 568 | | 548section 18 of chapter 12C if the commission determines that a performance improvement plan is |
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569 | 569 | | 549not an appropriate remedial measure. The civil penalty may amount to not more than the amount |
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570 | 570 | | 550of spending attributable to the health care entity that is in excess of the health care cost growth |
---|
571 | 571 | | 551benchmark and shall be deposited into the Healthcare Payment Reform Fund established under |
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572 | 572 | | 552section 100 of chapter 194 of the acts of 2011. Prior to assessing the civil penalty, the |
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573 | 573 | | 553commission shall provide the health care entity with written notice of its intent to assess the |
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574 | 574 | | 554penalty; provided, however, that the commission shall provide the health care entity not less than |
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575 | 575 | | 55510 days to respond to said written notice with a written request for a hearing; provided further, |
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576 | 576 | | 556that, if the health care entity requests a hearing, the commission shall hold the hearing within 30 |
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577 | 577 | | 557days of the commission’s receipt of the request; and provided further, that if the health care |
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578 | 578 | | 558entity does not request a hearing, the commission shall provide the health care entity with not |
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579 | 579 | | 559less than 30 days to respond in writing to said written notice. |
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580 | 580 | | 560 (q) The commission shall promulgate regulations necessary to implement this section; |
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581 | 581 | | 561provided, however, that notice of any proposed regulations shall be filed with the joint 28 of 119 |
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582 | 582 | | 562committee on state administration and regulatory oversight and the joint committee on health |
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583 | 583 | | 563care financing not less than180 days before adoption. |
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584 | 584 | | 564 SECTION 28. Section 11 of said chapter 6D, as so appearing, is hereby amended by |
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585 | 585 | | 565striking out, in line 3, the words “2 years” and inserting in place thereof the following words:- 1 |
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586 | 586 | | 566year. |
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587 | 587 | | 567 SECTION 29. Said section 11 of said chapter 6D, as so appearing, is hereby further |
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588 | 588 | | 568amended by striking out subsection (b) and inserting in place thereof the following subsection:- |
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589 | 589 | | 569 (b) The commission shall require that all provider organizations report information |
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590 | 590 | | 570detailed in section 9 of chapter 12C. The commission may specify additional data elements in a |
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591 | 591 | | 571given reporting year to support the development of the state health plan or the focused |
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592 | 592 | | 572assessments defined in section 22 of chapter 6D. |
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593 | 593 | | 573 SECTION 30. Said section 11 of said chapter 6D, as so appearing, is hereby further |
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594 | 594 | | 574amended by striking out subsection (d) and inserting in place thereof the following subsection:- |
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595 | 595 | | 575 (d) The commission may enter into interagency agreements with the center and other |
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596 | 596 | | 576state agencies to effectuate the goals of this section. |
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597 | 597 | | 577 SECTION 31. Said chapter 6D is hereby further amended by striking out sections 12 and |
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598 | 598 | | 57813, as so appearing, and inserting in place thereof the following 2 sections:- |
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599 | 599 | | 579 Section 12. (a) The commission shall ensure the timely reporting of information required |
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600 | 600 | | 580under section 11. The commission shall notify provider organizations of any applicable reporting |
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601 | 601 | | 581deadlines; provided, that the commission shall notify, in writing, a provider organization that has |
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602 | 602 | | 582failed to meet a reporting deadline and that failure to respond within 2 weeks of the receipt of the 29 of 119 |
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603 | 603 | | 583notice may result in penalties. The commission may assess a penalty against a provider |
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604 | 604 | | 584organization that fails, without just cause, to provide the requested information within 2 weeks |
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605 | 605 | | 585following receipt of the written notice required under this subsection of up to $10,000 per week |
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606 | 606 | | 586for each week of delay after the 2-week period following provider organization's receipt of the |
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607 | 607 | | 587written notice; provided, however, that the maximum annual penalty against a provider |
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608 | 608 | | 588organization under this section shall be $500,000 per registration cycle. Amounts collected under |
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609 | 609 | | 589this section shall be deposited in the Healthcare Payment Reform Fund established under section |
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610 | 610 | | 590100 of chapter 194 of the Acts of 2011. |
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611 | 611 | | 591 (b) Notwithstanding any general or special law to the contrary, any material change |
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612 | 612 | | 592notice submitted under section 13 and any determination of need application submitted under |
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613 | 613 | | 593sections 25B to 25G, inclusive, of chapter 111 by a provider organization that has failed to |
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614 | 614 | | 594provide required information pursuant to section 11 and section 9 of chapter 12C shall be |
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615 | 615 | | 595incomplete until such time as the provider organization has provided such required information. |
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616 | 616 | | 596 (c) Nothing in this chapter shall require a provider organization which represents |
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617 | 617 | | 597providers who collectively receive, less than $25,000,000 in annual net patient service revenue to |
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618 | 618 | | 598be registered if such provider or provider organization is not a risk-bearing provider organization |
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619 | 619 | | 599or is not owned or controlled, whether fully or partially, directly or indirectly, by a private equity |
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620 | 620 | | 600firm. |
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621 | 621 | | 601 Section 13. (a)(1) Every provider or provider organization shall, before making any |
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622 | 622 | | 602material change to its operations or governance structure, submit notice to the commission, the |
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623 | 623 | | 603center and the attorney general of such change not less than 60 days before the date of the |
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624 | 624 | | 604proposed change, provided, however, that material changes shall include, but not be limited to: 30 of 119 |
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625 | 625 | | 605(i) significant expansions in a provider or provider organization’s capacity; (ii) a corporate |
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626 | 626 | | 606merger, acquisition or affiliation of a provider or provider organization and a carrier; (iii) |
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627 | 627 | | 607mergers or acquisitions of hospitals or hospital systems; (iv) acquisition of insolvent provider |
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628 | 628 | | 608organizations; (v) significant new for-profit investment in, acquisitions of the assets of or |
---|
629 | 629 | | 609ownership or direct or indirect control of a provider or provider organization by for-profit |
---|
630 | 630 | | 610entities, including, but not limited to, private equity firms and management services |
---|
631 | 631 | | 611organizations; (vi) substantial acquisition or sale of assets for an ownership share or for the |
---|
632 | 632 | | 612purposes of a lease-back arrangement; (vii) conversion of a provider or provider organization |
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633 | 633 | | 613from a non-profit entity to a for-profit entity; and (viii) mergers or acquisitions of provider |
---|
634 | 634 | | 614organizations which will result in a provider organization having a dominant market share in a |
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635 | 635 | | 615given service or region. |
---|
636 | 636 | | 616 Within 30 days of receipt of a completed notice filed under the commission’s regulations, |
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637 | 637 | | 617the commission shall conduct a preliminary review to determine whether the material change is |
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638 | 638 | | 618likely to result in a significant impact on the commonwealth’s ability to meet the health care cost |
---|
639 | 639 | | 619growth benchmark established in section 9, or on the competitive market. If the commission |
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640 | 640 | | 620finds that the material change is likely to have a significant impact on the commonwealth’s |
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641 | 641 | | 621ability to meet the health care cost growth benchmark, or on the competitive market, the |
---|
642 | 642 | | 622commission may conduct a cost and market impact review under this section. |
---|
643 | 643 | | 623 (2) If the commission determines that a proposed material change is likely to have a |
---|
644 | 644 | | 624significant negative impact on health care consumers in the commonwealth, including through |
---|
645 | 645 | | 625significantly increased costs, significantly reduced quality, or significantly impaired access to |
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646 | 646 | | 626health care services, including for at-risk, underserved and government payer patient |
---|
647 | 647 | | 627populations, the commission may recommend modifications to the proposed material change to 31 of 119 |
---|
648 | 648 | | 628mitigate such impacts. Notwithstanding any general or special law to the contrary, failure to |
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649 | 649 | | 629modify the proposed material change to substantially address such impacts identified by the |
---|
650 | 650 | | 630commission shall constitute an unfair business practice under chapter 93A subject to challenge |
---|
651 | 651 | | 631pursuant to section 4 of said chapter 93A but not pursuant to sections 9 or 11 of said chapter |
---|
652 | 652 | | 63293A. The commission shall notify the office of the attorney general of any provider or provider |
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653 | 653 | | 633organization’s failure to modify the proposed material change to substantially address such |
---|
654 | 654 | | 634impacts. |
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655 | 655 | | 635 (b) In addition to the grounds for a cost and market impact review set forth in subsection |
---|
656 | 656 | | 636(a), if the commission finds, based on the center’s benchmark cycle report under section 16 of |
---|
657 | 657 | | 637chapter 12C, that the average of the annual percentage changes in total health care expenditures |
---|
658 | 658 | | 638during each year of the benchmark cycle exceeded the health care cost growth benchmark for |
---|
659 | 659 | | 639that benchmark cycle, the commission may conduct a cost and market impact review of any |
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660 | 660 | | 640provider organization identified by the center under section 18 of said chapter 12C. |
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661 | 661 | | 641 (c)(1) The commission shall initiate a cost and market impact review by sending the |
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662 | 662 | | 642provider or provider organization notice of a cost and market impact review, which shall explain |
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663 | 663 | | 643the basis for the review and the particular factors that the commission seeks to examine through |
---|
664 | 664 | | 644the review. The provider or provider organization shall submit to the commission, within 21 days |
---|
665 | 665 | | 645of the commission’s notice, a written response to the notice, including, but not limited to, any |
---|
666 | 666 | | 646information or documents sought by the commission that are described in the commission’s |
---|
667 | 667 | | 647notice. The commission may require that any provider, provider organization, payer, investor or |
---|
668 | 668 | | 648other party associated with a given transaction submit documents and information in connection |
---|
669 | 669 | | 649with a notice of material change or a cost and market impact review under this section. The |
---|
670 | 670 | | 650commission may also require, for a period of 5 years following the completion of a material 32 of 119 |
---|
671 | 671 | | 651change, that any provider or provider organization submit data and information to assess the |
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672 | 672 | | 652post-transaction impacts of a material change and compliance with any commitments or |
---|
673 | 673 | | 653conditions agreed to by the parties. The commission shall keep confidential all nonpublic |
---|
674 | 674 | | 654information and documents obtained under this section and shall not disclose the information or |
---|
675 | 675 | | 655documents to any person without the consent of the provider or payer that produced the |
---|
676 | 676 | | 656information or documents, except in a preliminary report or final report under this section if the |
---|
677 | 677 | | 657commission believes that such disclosure should be made in the public interest after taking into |
---|
678 | 678 | | 658account any privacy, trade secret or anti-competitive considerations. The confidential |
---|
679 | 679 | | 659information and documents shall not be public records and shall be exempt from disclosure |
---|
680 | 680 | | 660under clause Twenty-sixth of section 7 of chapter 4 or section 10 of chapter 66. |
---|
681 | 681 | | 661 (2) For any material change involving significant new for-profit investment in, |
---|
682 | 682 | | 662acquisitions of the assets of or ownership or direct or indirect control of a provider or provider |
---|
683 | 683 | | 663organization by a for-profit entity, the for-profit entity, and the parent company or person or |
---|
684 | 684 | | 664persons controlling the for-profit entity, if any, will be required to submit, at a minimum, the |
---|
685 | 685 | | 665following information to complete the notice: (i) information regarding the capital structure, |
---|
686 | 686 | | 666general financial condition, ownership and management of the for-profit entity and any person |
---|
687 | 687 | | 667controlling the for-profit entity; (ii) the identity and relationship of every member of the for- |
---|
688 | 688 | | 668profit entity; (iii) fully audited financial information for the preceding 5 fiscal years or for such |
---|
689 | 689 | | 669lesser period as the for-profit entity and any predecessors thereof shall have been in existence; |
---|
690 | 690 | | 670(iv) any plans or proposals to liquidate such provider or provider organization, to sell its assets or |
---|
691 | 691 | | 671merge or consolidate it with any person, or to make any other material change in its business or |
---|
692 | 692 | | 672corporate structure or management; (v) fully audited financial information of all health care |
---|
693 | 693 | | 673entities acquired by the for-profit entity, the parent company and person or persons controlling 33 of 119 |
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694 | 694 | | 674the for-profit entity, for the preceding 5 fiscal years or for such lesser period as the for-profit |
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695 | 695 | | 675entity and any predecessors thereof shall have been in existence as well as other financial |
---|
696 | 696 | | 676information the commission deems relevant, including, but not limited to, bankruptcy filings, |
---|
697 | 697 | | 677sales of non-clinical assets and dividend recapitalizations; (vi) operational information regarding |
---|
698 | 698 | | 678health care entities acquired by the acquiring party or person or persons controlling the acquiring |
---|
699 | 699 | | 679party for the preceding 10 fiscal years or for such lesser period as such acquiring party and any |
---|
700 | 700 | | 680predecessors thereof shall have been in existence, including, but not limited to, reduction or |
---|
701 | 701 | | 681closure of health care services; and (vii) such additional information as the commission may |
---|
702 | 702 | | 682deem necessary or appropriate for the protection of essential health services or to evaluate the |
---|
703 | 703 | | 683material change notice. |
---|
704 | 704 | | 684 (d) A cost and market impact review may examine factors relating to the provider or |
---|
705 | 705 | | 685provider organization’s business and its relative market position, including, but not limited to: (i) |
---|
706 | 706 | | 686the provider or provider organization’s size and market share within its primary service areas by |
---|
707 | 707 | | 687major service category and within its dispersed service areas; (ii) the provider or provider |
---|
708 | 708 | | 688organization’s prices for services, including its relative price compared to other providers for the |
---|
709 | 709 | | 689same services in the same market; (iii) the provider or provider organization’s health status |
---|
710 | 710 | | 690adjusted total medical expense, including its health status adjusted total medical expense |
---|
711 | 711 | | 691compared to similar providers; (iv) the quality of the services provided by the provider or |
---|
712 | 712 | | 692provider organization, including patient experience; (v) provider cost and cost trends in |
---|
713 | 713 | | 693comparison to total health care expenditures statewide; (vi) the availability and accessibility of |
---|
714 | 714 | | 694services similar to those provided, or proposed to be provided, through the provider or provider |
---|
715 | 715 | | 695organization within its primary service areas and dispersed service areas; (vii) the provider or |
---|
716 | 716 | | 696provider organization’s impact on competing options for the delivery of health care services 34 of 119 |
---|
717 | 717 | | 697within its primary service areas and dispersed service areas, including, if applicable, the impact |
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718 | 718 | | 698on existing service providers of a provider or provider organization’s expansion, affiliation, |
---|
719 | 719 | | 699merger or acquisition, to enter a primary or dispersed service area in which it did not previously |
---|
720 | 720 | | 700operate; (viii) the methods used by the provider or provider organization to attract patient volume |
---|
721 | 721 | | 701and recruit or acquire health care professionals or facilities; (ix) the role of the provider or |
---|
722 | 722 | | 702provider organization in serving at-risk, underserved and government payer patient populations, |
---|
723 | 723 | | 703including individuals with behavioral, substance use disorder and mental health conditions, |
---|
724 | 724 | | 704within its primary service areas and dispersed service areas; (x) the role of the provider or |
---|
725 | 725 | | 705provider organization in providing low margin or negative margin services within its primary |
---|
726 | 726 | | 706service areas and dispersed service areas; (xi) consumer concerns, including, but not limited to, |
---|
727 | 727 | | 707complaints or other allegations that the provider or provider organization has engaged in any |
---|
728 | 728 | | 708unfair method of competition or any unfair or deceptive act or practice; (xii) the cumulative |
---|
729 | 729 | | 709impact of mergers, acquisitions, affiliations or joint ventures on the health care market over a |
---|
730 | 730 | | 710reasonable period of time, as defined by the commission; (xiii) alignment with the state health |
---|
731 | 731 | | 711plan and any focused assessments conducted pursuant to section 22; and (xiv) any other factors |
---|
732 | 732 | | 712that the commission determines to be in the public interest. |
---|
733 | 733 | | 713 (e) The commission shall make factual findings and issue a preliminary report on the cost |
---|
734 | 734 | | 714and market impact review. In the report, the commission shall identify any provider or provider |
---|
735 | 735 | | 715organization that meets all of the following: (i) the provider or provider organization has, or |
---|
736 | 736 | | 716likely will have as a result of the proposed material change, a dominant market share for the |
---|
737 | 737 | | 717services it provides; (ii) the provider or provider organization charges, or likely will charge as a |
---|
738 | 738 | | 718result of the proposed material change, prices for services that are materially higher than the |
---|
739 | 739 | | 719median prices charged by all other providers for the same services in the same market; and (iii) 35 of 119 |
---|
740 | 740 | | 720the provider or provider organization has, or likely will have as a result of the proposed material |
---|
741 | 741 | | 721change, a health status adjusted total medical expense that is materially higher than the median |
---|
742 | 742 | | 722total medical expense of comparable providers in the same area. |
---|
743 | 743 | | 723 (f) Within 30 days after issuance of a preliminary report, the provider or provider |
---|
744 | 744 | | 724organization may respond in writing to the findings in the report. The commission shall then |
---|
745 | 745 | | 725issue its final report. The commission shall refer to the attorney general its report on any provider |
---|
746 | 746 | | 726or provider organization that meets all 3 criteria under subsection (e). The commission shall |
---|
747 | 747 | | 727issue its final report on the cost and market impact review within 185 days from the date that the |
---|
748 | 748 | | 728provider or provider organization has submitted a completed notice to the commission under the |
---|
749 | 749 | | 729commission’s regulations; provided, however, that the provider or provider organization has |
---|
750 | 750 | | 730certified substantial compliance with the commission’s requests for data and information |
---|
751 | 751 | | 731pursuant to subsection (c) within 21 days of the commission’s notice or by a later date set by |
---|
752 | 752 | | 732mutual agreement of the provider or provider organization and the commission. |
---|
753 | 753 | | 733 (g) Nothing in this section shall prohibit a proposed material change under subsection (a); |
---|
754 | 754 | | 734provided, however, that any proposed material change shall not be completed: (i) until not later |
---|
755 | 755 | | 735than 30 days after the commission has issued its final report; or (ii) if the attorney general brings |
---|
756 | 756 | | 736an action as described in paragraph (2) of subsection (a) or subsection (h), while such action is |
---|
757 | 757 | | 737pending and prior to a final judgment being issued by a court of competent jurisdiction, |
---|
758 | 758 | | 738whichever is later. |
---|
759 | 759 | | 739 (h) A provider or provider organization that meets the criteria in subsection (e) has |
---|
760 | 760 | | 740engaged, or through a material change will engage, in an unfair method of competition or unfair |
---|
761 | 761 | | 741and deceptive trade practice subject to challenge pursuant to section 4 of chapter 93A, but not 36 of 119 |
---|
762 | 762 | | 742sections 9 or 11 of said chapter 93A. The attorney general may take action under said chapter |
---|
763 | 763 | | 74393A or any other law to protect consumers in the health care market, including by bringing an |
---|
764 | 764 | | 744action seeking to restrain such violation of said chapter 93A. The commission’s final report may |
---|
765 | 765 | | 745be evidence in any such action brought by the attorney general. |
---|
766 | 766 | | 746 (i) Nothing in this section shall limit the authority of the attorney general to protect |
---|
767 | 767 | | 747consumers in the health care market under any other law. |
---|
768 | 768 | | 748 (j) The commission shall adopt regulations for conducting cost and market impact |
---|
769 | 769 | | 749reviews and for administering this section. These regulations shall include definitions of material |
---|
770 | 770 | | 750change and non-material change, primary service areas, dispersed service areas, dominant market |
---|
771 | 771 | | 751share, materially higher prices, materially higher health status adjusted total medical expenses |
---|
772 | 772 | | 752and any other terms as necessary to provide market participants with appropriate notice. These |
---|
773 | 773 | | 753regulations may identify filing thresholds in connection with this section; provided, however, |
---|
774 | 774 | | 754that the commission shall determine that multiple mergers, acquisitions or affiliations over time |
---|
775 | 775 | | 755may together meet such thresholds. All regulations promulgated by the commission shall comply |
---|
776 | 776 | | 756with chapter 30A. |
---|
777 | 777 | | 757 (k) Nothing in this section shall limit the application of other laws or regulations that may |
---|
778 | 778 | | 758be applicable to a provider or provider organization, including laws and regulations governing |
---|
779 | 779 | | 759insurance. |
---|
780 | 780 | | 760 (l) Upon issuance of its final report pursuant to subsection (f), the commission shall |
---|
781 | 781 | | 761provide a copy of said final report to the department of public health. The final report shall be |
---|
782 | 782 | | 762included in the written record and considered by the department of public health during its |
---|
783 | 783 | | 763review of an application for determination of need under section 25C of chapter 111 and 37 of 119 |
---|
784 | 784 | | 764considered where relevant in connection with licensure or other regulatory actions involving the |
---|
785 | 785 | | 765provider or provider organization. |
---|
786 | 786 | | 766 SECTION 32. Said chapter 6D is hereby further amended by adding the following 2 |
---|
787 | 787 | | 767sections:- |
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788 | 788 | | 768 Section 22. (a)(1) Not less than once every 5 years, the commission shall develop a state |
---|
789 | 789 | | 769health plan in consultation with the executive office of health and human services, the |
---|
790 | 790 | | 770department of public health, the office of Medicaid, the department of mental health, the division |
---|
791 | 791 | | 771of insurance, the executive office of elder affairs, the center for health information and analysis |
---|
792 | 792 | | 772and other state agencies as appropriate. |
---|
793 | 793 | | 773 (2) The state health plan shall identify: (i) the current and anticipated needs of the |
---|
794 | 794 | | 774commonwealth for health care services, providers, programs and facilities; (ii) the existing health |
---|
795 | 795 | | 775care resources available to meet those needs; (iii) recommendations for the appropriate supply |
---|
796 | 796 | | 776and distribution of resources, workforce, programs, capacities, technologies and services on a |
---|
797 | 797 | | 777statewide and regional basis; (iv) major barriers preventing communities and residents from |
---|
798 | 798 | | 778accessing needed health care; (v) priorities for addressing those barriers; and (vi) |
---|
799 | 799 | | 779recommendations for any further legislative or other state action to assist the commonwealth in |
---|
800 | 800 | | 780achieving the recommendations identified in the plan. |
---|
801 | 801 | | 781 (3) The state health plan shall be based on data from all available sources, including data |
---|
802 | 802 | | 782collected by the commission, the center for health information and analysis, the executive office |
---|
803 | 803 | | 783of health and human services, the department of public health, the office of Medicaid, the |
---|
804 | 804 | | 784department of mental health, the division of insurance, the executive office of elder affairs, the |
---|
805 | 805 | | 785board of registration in medicine, the bureau of health professions licensure, the office of the 38 of 119 |
---|
806 | 806 | | 786attorney general and other state agencies as appropriate. All such agencies shall provide data and |
---|
807 | 807 | | 787information necessary for the commission to create the plan. |
---|
808 | 808 | | 788 (4) The state health plan shall include recommendations across a range of health care |
---|
809 | 809 | | 789services, including, but not limited to: (i) acute care; (ii) non-acute care; (iii) specialty care, |
---|
810 | 810 | | 790including, but not limited to, burn, coronary care, cancer care, neonatal care, post-obstetric and |
---|
811 | 811 | | 791post-operative recovery care, pulmonary care, renal dialysis and surgical, including trauma and |
---|
812 | 812 | | 792intensive care units; (iv) skilled nursing facilities; (v) assisted living facilities; (vi) long-term care |
---|
813 | 813 | | 793facilities; (vii) ambulatory surgical centers; (viii) office-based surgical centers; (ix) urgent care |
---|
814 | 814 | | 794centers; (x) home health; (xi) adult and pediatric behavioral health and mental health services |
---|
815 | 815 | | 795and supports; (xii) substance use disorder treatment and recovery services; (xiii) emergency care; |
---|
816 | 816 | | 796(xiv) ambulatory care services; (xv) primary care resources; (xvi) pediatric care services; (xvii) |
---|
817 | 817 | | 797pharmacy and pharmacological services; (xviii) family planning services; (xix) obstetrics and |
---|
818 | 818 | | 798gynecology and maternal health services; (xx) allied health services, including, but not limited |
---|
819 | 819 | | 799to, optometric care, chiropractic services, oral health care and midwifery services; (xxi) federally |
---|
820 | 820 | | 800qualified health centers and free clinics; (xxii) technologies or equipment defined as innovative |
---|
821 | 821 | | 801services or new technologies by the department of public health pursuant to section 25B of |
---|
822 | 822 | | 802chapter 111; (xxiii) hospice and palliative care service; (xxiv) health screening and early |
---|
823 | 823 | | 803intervention services; and (xxv) any other service or resource identified by the commission. |
---|
824 | 824 | | 804 (5) The goal of the state health plan shall be to promote the appropriate and equitable |
---|
825 | 825 | | 805distribution of health care resources across geographic regions of the commonwealth based on |
---|
826 | 826 | | 806the needs of the population on a statewide basis and the needs of particular geographic and |
---|
827 | 827 | | 807demographic groups. The state health plan shall seek to support the commonwealth's goals of: (i) |
---|
828 | 828 | | 808maintaining and improving the quality of and access to health care services; (ii) ensuring a stable 39 of 119 |
---|
829 | 829 | | 809and adequate health care workforce; (iii) meeting the health care cost growth benchmark |
---|
830 | 830 | | 810established pursuant to section 9; (iv) supporting innovative health care delivery and alternative |
---|
831 | 831 | | 811payment models as identified by the commission; (v) reducing unnecessary duplication of health |
---|
832 | 832 | | 812care resources; (vi) advancing health equity and addressing disparities in the health care system |
---|
833 | 833 | | 813based on the needs of particular demographic factors, including, but not limited to, race, |
---|
834 | 834 | | 814ethnicity, immigration status, sexual orientation, gender identity, geographic location, age, |
---|
835 | 835 | | 815language spoken, ability and socioeconomic status; (vii) integrating oral health, mental health, |
---|
836 | 836 | | 816behavioral and substance use disorder treatment services with overall medical care; (viii) |
---|
837 | 837 | | 817aligning housing, health care and home care to improve overall health outcomes and reduce |
---|
838 | 838 | | 818costs; (ix) tracking trends in utilization and promoting the best standards of care; and (x) |
---|
839 | 839 | | 819ensuring equitable access to health care resources across geographic regions of the |
---|
840 | 840 | | 820commonwealth. |
---|
841 | 841 | | 821 (6) The commission shall consult with the advisory council established pursuant to |
---|
842 | 842 | | 822section 4 in the development of the state health plan. |
---|
843 | 843 | | 823 (7) In developing the state health plan, the commission, in consultation with the |
---|
844 | 844 | | 824department of public health, shall conduct at least 1 public hearing seeking input on the state |
---|
845 | 845 | | 825health plan and shall give interested persons an opportunity to submit their views orally and in |
---|
846 | 846 | | 826writing. In addition, the commission may create and maintain a website to allow members of the |
---|
847 | 847 | | 827public to submit comments electronically and review comments submitted by others. |
---|
848 | 848 | | 828 (8) The commission may require the submission of data and documents from providers, |
---|
849 | 849 | | 829provider organizations and payers to support creation of the state health plan; provided, that the |
---|
850 | 850 | | 830information is not already required to be reported to another state agency and accessible to the 40 of 119 |
---|
851 | 851 | | 831commission. Nonpublic clinical, financial, strategic or operational documents or information |
---|
852 | 852 | | 832provided to the commission in connection with this section shall be subject to section 2A. |
---|
853 | 853 | | 833 (b)(1) In addition to the state health plan, the commission shall conduct regular, focused |
---|
854 | 854 | | 834assessments of provider supply and distribution in relation to projected need in at least 1 specific |
---|
855 | 855 | | 835service line. Each assessment shall be conducted in consultation with other state agencies as |
---|
856 | 856 | | 836appropriate, including, but not limited to, the executive office of health and human services, the |
---|
857 | 857 | | 837department of public health, the department of mental health, the office of Medicaid, the division |
---|
858 | 858 | | 838of insurance, the center for health information and analysis, the executive office of elder affairs, |
---|
859 | 859 | | 839the board of registration in medicine, the bureau of health professions licensure and the office of |
---|
860 | 860 | | 840the attorney general. All such agencies shall provide data and information necessary for the |
---|
861 | 861 | | 841commission to conduct the assessment. The commission shall consider available state and |
---|
862 | 862 | | 842national data and academic research on health service supply and need and relevant community |
---|
863 | 863 | | 843health needs assessments by non-profit hospitals and other organizations and other individual |
---|
864 | 864 | | 844and community statements of need. |
---|
865 | 865 | | 845 (2) Each focused assessment shall examine at least 1 specific service line and at least 1 |
---|
866 | 866 | | 846relevant region and may examine other factors in the public interest, such as populations served, |
---|
867 | 867 | | 847as appropriate. The service lines and regions shall be identified and prioritized for assessment by |
---|
868 | 868 | | 848the commission in consultation with the above-referenced agencies, as consistent with available |
---|
869 | 869 | | 849resources. In prioritizing service lines and regions, the commission may consider factors |
---|
870 | 870 | | 850including, but not limited to: (i) services with limited alternatives or substitutions; (ii) services |
---|
871 | 871 | | 851where supply has been shown to be misaligned with need nationally or in academic research; (iii) |
---|
872 | 872 | | 852services or regions undergoing significant changes in ownership, supply, or distribution; (iv) |
---|
873 | 873 | | 853services or regions with evidence of access challenges or barriers, particularly for vulnerable 41 of 119 |
---|
874 | 874 | | 854populations; (v) input from the advisory council established pursuant to section 4; and (vi) |
---|
875 | 875 | | 855requests for analysis from the executive office of health and human services or other agencies; |
---|
876 | 876 | | 856provided, that prioritized service lines under this paragraph shall include primary care and |
---|
877 | 877 | | 857behavioral health. |
---|
878 | 878 | | 858 (3) Each assessment may include findings that include, but are not limited to: (i) the |
---|
879 | 879 | | 859extent to which supply of a given service line aligns with projected need at the statewide or |
---|
880 | 880 | | 860regional level; (ii) health system factors driving any documented health disparities; (iii) services |
---|
881 | 881 | | 861or providers, including in a specific geographic area, that are critical to the proper functioning of |
---|
882 | 882 | | 862the health care system; (iv) estimates of where and how many additional units of service would |
---|
883 | 883 | | 863be needed in the state or in a specific geographic area to meet projected need; (v) identification |
---|
884 | 884 | | 864of barriers impacting accessibility of available supply by specific populations; and (vi) policy |
---|
885 | 885 | | 865recommendations to address the drivers of disparities, access barriers and areas of misalignment |
---|
886 | 886 | | 866of need and supply. |
---|
887 | 887 | | 867 (4) The commission shall consult with the advisory council established pursuant to |
---|
888 | 888 | | 868section 4 in the development of such focused assessments. |
---|
889 | 889 | | 869 (5) The commission, in consultation with the department of public health, shall conduct |
---|
890 | 890 | | 870at least 1 public hearing seeking input on each focused assessment and shall give interested |
---|
891 | 891 | | 871persons an opportunity to submit testimony orally and in writing. |
---|
892 | 892 | | 872 (6) The commission may require the submission of data and documents from payers, |
---|
893 | 893 | | 873providers or provider organizations that offer a service that is the subject of an assessment |
---|
894 | 894 | | 874conducted under this section; provided, that the information is not already reported to another |
---|
895 | 895 | | 875state agency and made accessible to the commission. Nonpublic clinical, financial, strategic or 42 of 119 |
---|
896 | 896 | | 876operational documents or information provided to the commission in connection with this section |
---|
897 | 897 | | 877shall be subject to section 2A. |
---|
898 | 898 | | 878 (c) The commission shall publish analyses, reports and interpretations of information |
---|
899 | 899 | | 879collected pursuant to this section to promote awareness of the distribution and nature of health |
---|
900 | 900 | | 880care resources in the commonwealth. |
---|
901 | 901 | | 881 (d) Biennially, not later than January 1, the commission shall file a report with the joint |
---|
902 | 902 | | 882committee on health care financing , which shall include, but not be limited to: (i) a summary of |
---|
903 | 903 | | 883the current state health plan and a description of focused assessments conducted during the past 2 |
---|
904 | 904 | | 884years; (ii) a summary of actions taken by the commission and progress made toward developing |
---|
905 | 905 | | 885the state health plan and focused assessments during the past 2 years; and (iii) recommendations |
---|
906 | 906 | | 886for further legislative action to assist the commission in its implementation of this section. |
---|
907 | 907 | | 887 Section 23. (a) A provider or a provider organization in which a private equity firm has a |
---|
908 | 908 | | 888financial interest shall not: (i) meet or exceed the maximum adjusted debt to adjusted EBITDA |
---|
909 | 909 | | 889ratio; (ii) otherwise become highly leveraged, as determined by the commission; (iii) transact |
---|
910 | 910 | | 890with an unsafe financial actor; (iv) for the period during which the private equity firm has a |
---|
911 | 911 | | 891financial interest in the provider or provider organization, (A) provide capital distributions, |
---|
912 | 912 | | 892including, but not limited, to cash dividends, stock dividends that are not strictly dilutive or any |
---|
913 | 913 | | 893other similar distributions, (B) perform stock buybacks, stock redemptions or similar transactions |
---|
914 | 914 | | 894or (C) pay to a private equity firm management fees or similar fees or costs; or (v) perform any |
---|
915 | 915 | | 895other action or exceed any other metric the commission determines may cause a provider or |
---|
916 | 916 | | 896provider organization to become financially distressed. 43 of 119 |
---|
917 | 917 | | 897 (b) Within 30 days of the commission receiving a referral from the center pursuant to |
---|
918 | 918 | | 898paragraph (4) of subsection (e) of section 9 of chapter 12C or the commission becoming aware of |
---|
919 | 919 | | 899a potential violation of subsection (a) pursuant to the filing of a completed notice of material |
---|
920 | 920 | | 900change under section 13, the commission shall make a determination of whether there has been a |
---|
921 | 921 | | 901violation. If the commission determines a violation has occurred, the commission shall require |
---|
922 | 922 | | 902the provider to come into compliance with said subsection (a) and may set conditions that the |
---|
923 | 923 | | 903provider or provider organization shall follow to come into compliance. The commission shall |
---|
924 | 924 | | 904notify the provider or provider organization in writing of its determination, conditions, if any, |
---|
925 | 925 | | 905and reasoning. The provider or provider organization shall have not less than 30 days to respond |
---|
926 | 926 | | 906in writing and 10 days to request a hearing from the date of notification. If a hearing is requested, |
---|
927 | 927 | | 907the hearing shall be held within 30 days of the commission’s receipt of the request. Within 10 |
---|
928 | 928 | | 908days of receiving written comments or holding any requested hearing, whichever is later, the |
---|
929 | 929 | | 909commission shall notify the provider or provider organization in writing that the provider or |
---|
930 | 930 | | 910provider organization is required to come into compliance with section (a) and which conditions, |
---|
931 | 931 | | 911if any, shall go into effect. Upon providing notice, such requirements and conditions, if any, shall |
---|
932 | 932 | | 912go into effect. |
---|
933 | 933 | | 913 In making the determinations pursuant to subsection (a), the commission may consider all |
---|
934 | 934 | | 914publicly available data and documents, including information submitted to the commission and |
---|
935 | 935 | | 915the center under any authority. The commission may also solicit additional non-public |
---|
936 | 936 | | 916information from providers to the extent necessary to achieve the purposes of this section. The |
---|
937 | 937 | | 917commission shall keep confidential all nonpublic information and documents obtained under this |
---|
938 | 938 | | 918section, and such information shall not be public records and shall be exempt from disclosure |
---|
939 | 939 | | 919under clause Twenty-sixth of section 7 of chapter 4 or section 10 of chapter 66. 44 of 119 |
---|
940 | 940 | | 920 (c)(1) Within 3 months, or a shorter reasonable time as determined by the commission, |
---|
941 | 941 | | 921the commission shall determine whether the provider or provider organization has substantially |
---|
942 | 942 | | 922complied with its conditions or if no conditions were set, whether the provider or provider |
---|
943 | 943 | | 923organization has come into compliance with subsection (a). The commission shall notify the |
---|
944 | 944 | | 924provider or provider organization of its determination and reasoning, and the provider or |
---|
945 | 945 | | 925provider organization shall have not less than 30 days to respond in writing and 10 days to |
---|
946 | 946 | | 926request a hearing from the date of notification. If a hearing is requested, the hearing shall be held |
---|
947 | 947 | | 927within 30 days of the commission’s receipt of the request. Within 10 days of receiving written |
---|
948 | 948 | | 928comments and holding any requested hearing, whichever is later, the commission shall make a |
---|
949 | 949 | | 929final determination and notify the provider or provider organization of the determination in |
---|
950 | 950 | | 930writing. |
---|
951 | 951 | | 931 (2) If the commission makes a final determination that the provider or provider |
---|
952 | 952 | | 932organization has failed to substantially implement the commission’s conditions, or, if no |
---|
953 | 953 | | 933conditions were set, to come in compliance with subsection (a), the department of public health |
---|
954 | 954 | | 934may collect the bond deposited. The commission shall notify the department of public health of |
---|
955 | 955 | | 935its determination and refer the provider or provider organization to the attorney general. |
---|
956 | 956 | | 936 (3) Failure to substantially implement the commission’s conditions, or, if no conditions |
---|
957 | 957 | | 937are set, failure to come in compliance with subsection (a) shall constitute a violation of said |
---|
958 | 958 | | 938chapter 93A. Only the attorney general, or an organization representing workers who: (i) worked |
---|
959 | 959 | | 939for the provider or provider organization; (ii) worked in the provider or provider organization’s |
---|
960 | 960 | | 940facilities, if any; or (iii) contracted with the provider or provider organization, may bring an |
---|
961 | 961 | | 941action under chapter 93A for such a violation. The commission’s final determination may be |
---|
962 | 962 | | 942used as prima facie evidence of a violation of said chapter 93A. 45 of 119 |
---|
963 | 963 | | 943 (d) A private equity firm shall deposit, upon submission of a notice of material change |
---|
964 | 964 | | 944pursuant to section 13 of chapter 6D, a bond with the department of public health ensuring that |
---|
965 | 965 | | 945the provisions of subsection (a) shall not be violated; provided, however, that the private equity |
---|
966 | 966 | | 946firm shall not use any of the provider or provider organization’s assets or property as security for |
---|
967 | 967 | | 947the bond, pay for the bond by placing debt on the provider or provider organization or otherwise |
---|
968 | 968 | | 948permit the provider or provider organization to pay the bond on the private equity firm’s behalf |
---|
969 | 969 | | 949or allow the provider or provider organization to be liable for the bond. |
---|
970 | 970 | | 950 SECTION 33. Section 5A of chapter 12 of the General Laws, as so appearing, is hereby |
---|
971 | 971 | | 951amended by striking out, in line 26, the words “or ‘knowingly’” and inserting in place thereof the |
---|
972 | 972 | | 952following words:- , “knowingly” or “knows”. |
---|
973 | 973 | | 953 SECTION 34. Said section 5A of said chapter 12, as so appearing, is hereby further |
---|
974 | 974 | | 954amended by inserting after the definition of “Overpayment” the following definition:- |
---|
975 | 975 | | 955 “Ownership or investment interest”, any: (1) direct or indirect possession of equity in the |
---|
976 | 976 | | 956capital, stock or profits totaling more than 10 per cent of an entity; (2) interest held by an |
---|
977 | 977 | | 957investor or group of investors who engages in the raising or returning of capital and who invests, |
---|
978 | 978 | | 958develops or disposes of specified assets; (3) interest held by a pool of funds by investors, |
---|
979 | 979 | | 959including a pool of funds managed or controlled by private limited partnerships, if those |
---|
980 | 980 | | 960investors or the management of that pool or private limited partnership employ investment |
---|
981 | 981 | | 961strategies of any kind to earn a return on that pool of funds; or (4) interest held by a real estate |
---|
982 | 982 | | 962investment trust. |
---|
983 | 983 | | 963 SECTION 35. Section 5B of said chapter 12, as so appearing, is hereby amended by |
---|
984 | 984 | | 964striking out, in line 29, the word “or”, the second time it appears. 46 of 119 |
---|
985 | 985 | | 965 SECTION 36. Said section 5B of said chapter 12, as so appearing, is hereby further |
---|
986 | 986 | | 966amended by inserting after the word “applicable”, in lines 38 and 39, the following words:- ; or |
---|
987 | 987 | | 967(11) has an ownership or investment interest in any person who violates clauses (1) to (10), |
---|
988 | 988 | | 968inclusive, knows about the violation, and fails to disclose the violation to the commonwealth or a |
---|
989 | 989 | | 969political subdivision thereof within 60 days of identifying the violation. |
---|
990 | 990 | | 970 SECTION 37. Section 11N of said chapter 12, as so appearing, is hereby amended by |
---|
991 | 991 | | 971striking out, in line 7, the words “or provider organization” and inserting in place thereof the |
---|
992 | 992 | | 972following words:- , provider organization, private equity firm, real estate investment trust, |
---|
993 | 993 | | 973management services organization, pharmaceutical manufacturing company and pharmacy |
---|
994 | 994 | | 974benefit manager. |
---|
995 | 995 | | 975 SECTION 38. Said section 11N of said chapter 12, as so appearing, is hereby further |
---|
996 | 996 | | 976amended by striking out subsection (b) and inserting in place thereof the following subsection:- |
---|
997 | 997 | | 977 (b) The attorney general may investigate any provider organization referred to the |
---|
998 | 998 | | 978attorney general by the health policy commission under chapter 6D to determine whether the |
---|
999 | 999 | | 979provider organization engaged in unfair methods of competition or anti-competitive behavior in |
---|
1000 | 1000 | | 980violation of chapter 93A or any other law, and, if appropriate, take action under said chapter 93A |
---|
1001 | 1001 | | 981or any other law to protect consumers in the health care market, including, but not limited to, an |
---|
1002 | 1002 | | 982action for injunctive relief. |
---|
1003 | 1003 | | 983 SECTION 39. Section 1 of chapter 12C of the General Laws, as so appearing, is hereby |
---|
1004 | 1004 | | 984amended by inserting after the definition of “Ambulatory surgical center services” the following |
---|
1005 | 1005 | | 985definition:- 47 of 119 |
---|
1006 | 1006 | | 986 “Benchmark cycle”, a period of 2 consecutive calendar years during which the projected |
---|
1007 | 1007 | | 987annualized growth rate in total health care expenditures in the commonwealth is calculated |
---|
1008 | 1008 | | 988pursuant to section 9 of chapter 6D and monitored pursuant to section 10 of said chapter 6D. |
---|
1009 | 1009 | | 989 SECTION 40. Said section 1 of said chapter 12C, as so appearing, is hereby further |
---|
1010 | 1010 | | 990amended by inserting after the definition of “Fee-for-service” the following definition:- |
---|
1011 | 1011 | | 991 “Financial interest”, when a private equity firm or its corporate affiliate has a direct or |
---|
1012 | 1012 | | 992indirect ownership share of, or controlling interest in, or is a holder of significant debt from a |
---|
1013 | 1013 | | 993provider or provider organization or the provider or provider organization’s corporate affiliates |
---|
1014 | 1014 | | 994 SECTION 41. Said section 1 of said chapter 12C, as so appearing, is hereby further |
---|
1015 | 1015 | | 995amended by striking out the definition of “Health care cost growth benchmark” and inserting in |
---|
1016 | 1016 | | 996place thereof the following 2 definitions:- |
---|
1017 | 1017 | | 997 “Health care cost growth benchmark”, the projected annualized growth rate in total health |
---|
1018 | 1018 | | 998care expenditures in the commonwealth during a benchmark cycle as established in section 9 of |
---|
1019 | 1019 | | 999chapter 6D. |
---|
1020 | 1020 | | 1000 “Health care entity”, as defined in section 1 of chapter 6D. |
---|
1021 | 1021 | | 1001 SECTION 42. Said section 1 of said chapter 12C, as so appearing, is hereby further |
---|
1022 | 1022 | | 1002amended by inserting after the definition of “Health care services” the following 2 definitions:- |
---|
1023 | 1023 | | 1003 “Health disparities”, preventable differences in the burden of disease, injury, violence or |
---|
1024 | 1024 | | 1004opportunities to achieve optimal health that are experienced by socially disadvantaged |
---|
1025 | 1025 | | 1005populations. 48 of 119 |
---|
1026 | 1026 | | 1006 “Health equity”, the state in which a health system offers the infrastructure, facilities, |
---|
1027 | 1027 | | 1007services, geographic coverage, affordability and all other relevant features, conditions and |
---|
1028 | 1028 | | 1008capabilities that will provide all people with the opportunity and reasonable expectation that they |
---|
1029 | 1029 | | 1009can reach their full health potential and well-being and are not disadvantaged in access to health |
---|
1030 | 1030 | | 1010care by their race, ethnicity, language, disability, age, gender, gender identity, sexual orientation, |
---|
1031 | 1031 | | 1011social class, intersections among these communities or identities or their socially determined |
---|
1032 | 1032 | | 1012circumstances. |
---|
1033 | 1033 | | 1013 SECTION 43. Said section 1 of said chapter 12C, as so appearing, is hereby further |
---|
1034 | 1034 | | 1014amended by inserting after the definition of “Major service category” the following 2 |
---|
1035 | 1035 | | 1015definitions:- |
---|
1036 | 1036 | | 1016 “Management services organization”, a business that provides management or |
---|
1037 | 1037 | | 1017administrative services to a provider or provider organization for compensation. “Maximum |
---|
1038 | 1038 | | 1018adjusted debt to adjusted EBITDA ratio”, the highest ratio of total adjusted debt to adjusted |
---|
1039 | 1039 | | 1019earnings before interest, taxes, depreciation and amortization the commission determines that a |
---|
1040 | 1040 | | 1020provider or provider organization can have without becoming financially unstable; provided |
---|
1041 | 1041 | | 1021further, that the commission, in consultation with the center, shall establish a standard method of |
---|
1042 | 1042 | | 1022calculating and reporting total adjusted debt and adjusted earnings before interest, taxes, |
---|
1043 | 1043 | | 1023depreciation and amortization; and provided further, that the methodology and reporting shall |
---|
1044 | 1044 | | 1024include capitalized lease obligations. |
---|
1045 | 1045 | | 1025 SECTION 44. Said section 1 of said chapter 12C, as so appearing, is hereby further |
---|
1046 | 1046 | | 1026amended by inserting after the definition of “Patient-centered medical home” the following 3 |
---|
1047 | 1047 | | 1027definitions:- 49 of 119 |
---|
1048 | 1048 | | 1028 “Payer”, any entity, other than an individual, that pays providers for the provision of |
---|
1049 | 1049 | | 1029health care services; provided, that “payer” shall include both governmental and private entities; |
---|
1050 | 1050 | | 1030provided further, that “payer” shall include self-insured plans to the extent allowed under the |
---|
1051 | 1051 | | 1031federal Employee Retirement Income Security Act of 1974. |
---|
1052 | 1052 | | 1032 “Pharmaceutical manufacturing company”, an entity engaged in the: (i) production, |
---|
1053 | 1053 | | 1033preparation, propagation, compounding, conversion or processing of prescription drugs, directly |
---|
1054 | 1054 | | 1034or indirectly, by extraction from substances of natural origin, independently by means of |
---|
1055 | 1055 | | 1035chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging, |
---|
1056 | 1056 | | 1036repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that |
---|
1057 | 1057 | | 1037“pharmaceutical manufacturing company” shall not include a wholesale drug distributor licensed |
---|
1058 | 1058 | | 1038under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said |
---|
1059 | 1059 | | 1039chapter 112. |
---|
1060 | 1060 | | 1040 “Pharmacy benefit manager”, a person, business or other entity, however organized, that, |
---|
1061 | 1061 | | 1041directly or through a subsidiary, provides pharmacy benefit management services for prescription |
---|
1062 | 1062 | | 1042drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self- |
---|
1063 | 1063 | | 1043insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit |
---|
1064 | 1064 | | 1044management services shall include, but not be limited to: (i) the processing and payment of |
---|
1065 | 1065 | | 1045claims for prescription drugs; (ii) the performance of drug utilization review; (iii) the processing |
---|
1066 | 1066 | | 1046of drug prior authorization requests; (iv) pharmacy contracting; (v) the adjudication of appeals or |
---|
1067 | 1067 | | 1047grievances related to prescription drug coverage contracts; (vi) formulary administration; (vii) |
---|
1068 | 1068 | | 1048drug benefit design; (viii) mail and specialty drug pharmacy services; (ix) cost containment; (x) |
---|
1069 | 1069 | | 1049clinical, safety and adherence programs for pharmacy services; and (xi) managing the cost of |
---|
1070 | 1070 | | 1050covered prescription drugs; provided further, that “pharmacy benefit manager” shall include a 50 of 119 |
---|
1071 | 1071 | | 1051health benefit plan sponsor that does not contract with a pharmacy benefit manager and manages |
---|
1072 | 1072 | | 1052its own prescription drug benefits unless specifically exempted by the commission. |
---|
1073 | 1073 | | 1053 SECTION 45. Said section 1 of said chapter 12C, as so appearing, is hereby further |
---|
1074 | 1074 | | 1054amended by inserting after the definition of “Primary service area” the following definition:- |
---|
1075 | 1075 | | 1055 “Private equity firm”, a publicly traded or non-publicly traded company that collects |
---|
1076 | 1076 | | 1056capital investments from individuals or entities and purchases, as a parent company or through |
---|
1077 | 1077 | | 1057another entity that it completely or partially owns or controls, a direct or indirect ownership share |
---|
1078 | 1078 | | 1058of or controlling interest in, or otherwise obtains a financial interest in, a provider, provider |
---|
1079 | 1079 | | 1059organization or management services organization; provided, however, that “private equity firm” |
---|
1080 | 1080 | | 1060shall not include venture capital firms exclusively funding startups or other early-stage |
---|
1081 | 1081 | | 1061businesses. |
---|
1082 | 1082 | | 1062 SECTION 46. Said section 1 of said chapter 12C, as so appearing, is hereby further |
---|
1083 | 1083 | | 1063amended by striking out the definition of “Provider organization” and inserting in place thereof |
---|
1084 | 1084 | | 1064the following definition:- |
---|
1085 | 1085 | | 1065 “Provider organization”, any corporation, partnership, business trust, association or |
---|
1086 | 1086 | | 1066organized group of persons, which is in the business of health care delivery or management, |
---|
1087 | 1087 | | 1067whether incorporated or not, that represents at least 1 health care providers in contracting with |
---|
1088 | 1088 | | 1068carriers, third party administrators or public payers for the payments of health care services; |
---|
1089 | 1089 | | 1069provided, that ''provider organization'' shall include, but not be limited to, physician |
---|
1090 | 1090 | | 1070organizations, physician-hospital organizations, independent practice associations, provider |
---|
1091 | 1091 | | 1071networks, accountable care organizations, management services organizations, providers that are |
---|
1092 | 1092 | | 1072owned or controlled, fully or partially, by for-profit entities, including, but not limited to, private 51 of 119 |
---|
1093 | 1093 | | 1073equity firms, and any other organization that contracts with carriers, third party administrators or |
---|
1094 | 1094 | | 1074public payers for payment for health care services; and provided, further that “provider |
---|
1095 | 1095 | | 1075organization” shall not include any integrated care network that is owned and directed by a long- |
---|
1096 | 1096 | | 1076term care providers. |
---|
1097 | 1097 | | 1077 SECTION 47. Said section 1 of said chapter 12C, as so appearing, is hereby further |
---|
1098 | 1098 | | 1078amended by inserting after the definition of “Quality measures” the following definition:- |
---|
1099 | 1099 | | 1079 “Real estate investment trust”, a real estate investment trust as defined in 26 U.S.C. 856. |
---|
1100 | 1100 | | 1080 SECTION 48. Said section 1 of said chapter 12C, as so appearing, is hereby further |
---|
1101 | 1101 | | 1081amended by inserting after the definition of “Total health care expenditures” the following 2 |
---|
1102 | 1102 | | 1082definitions:- |
---|
1103 | 1103 | | 1083 “Total medical expenses”, the total cost of care for the patient population associated with |
---|
1104 | 1104 | | 1084a provider organization based on allowed claims for all categories of medical expenses and all |
---|
1105 | 1105 | | 1085non-claims related payments to providers. |
---|
1106 | 1106 | | 1086 “Unsafe financial actor”, a private equity firm or real estate investment trust that had a |
---|
1107 | 1107 | | 1087financial interest in a provider or provider organization closing, declaring bankruptcy or |
---|
1108 | 1108 | | 1088otherwise discontinuing its operations within 15 years of the private equity firm or real estate |
---|
1109 | 1109 | | 1089investment trust’s financial interest in the provider or provider organization. |
---|
1110 | 1110 | | 1090 SECTION 49. Section 2A of said chapter 12C, as so appearing, is hereby amended by |
---|
1111 | 1111 | | 1091inserting after the word “cybersecurity”, in line 9, the following words:- and 1 of whom shall |
---|
1112 | 1112 | | 1092have experience in health equity advocacy. 52 of 119 |
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1113 | 1113 | | 1093 SECTION 50. Section 3 of said chapter 12C, as so appearing, is hereby amended by |
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1114 | 1114 | | 1094striking out, in line 11, the word “benchmark” and inserting in place thereof the following |
---|
1115 | 1115 | | 1095words:- and affordability benchmarks. |
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1116 | 1116 | | 1096 SECTION 51. Said section 3 of said chapter 12C, as so appearing, is hereby further |
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1117 | 1117 | | 1097amended by striking out, in line 12, the words “section 9” and inserting in place thereof the |
---|
1118 | 1118 | | 1098following words:- sections 9 and 9A. |
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1119 | 1119 | | 1099 SECTION 52. The first paragraph of section 7 of said chapter 12C, as so appearing, is |
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1120 | 1120 | | 1100hereby amended by adding the following sentence:- |
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1121 | 1121 | | 1101 Each pharmaceutical manufacturing company and pharmacy benefit manager shall pay to |
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1122 | 1122 | | 1102the commonwealth an amount for the estimated expenses of the center and for the other purposes |
---|
1123 | 1123 | | 1103described in this chapter. |
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1124 | 1124 | | 1104 SECTION 53. Said section 7 of said chapter 12C, as so appearing, is hereby further |
---|
1125 | 1125 | | 1105amended by striking out, in lines 8 and 42, the figure “33” and inserting in place thereof, in each |
---|
1126 | 1126 | | 1106instance, the following figure:- “25”. |
---|
1127 | 1127 | | 1107 SECTION 54. Said section 7 of said chapter 12C, as so appearing, is hereby further |
---|
1128 | 1128 | | 1108amended by adding following 3 paragraphs:- To the maximum extent under federal law, |
---|
1129 | 1129 | | 1109provided that such assessment shall not result in any reduction of federal financial participation |
---|
1130 | 1130 | | 1110in Medicaid, the assessed amount for pharmaceutical manufacturing companies shall be not less |
---|
1131 | 1131 | | 1111than 25 per cent of the amount appropriated by the general court for the expenses of the center |
---|
1132 | 1132 | | 1112minus amounts collected from: (i) filing fees; (ii) fees and charges generated by the center's |
---|
1133 | 1133 | | 1113publication or dissemination of reports and information; and (iii) federal matching revenues |
---|
1134 | 1134 | | 1114received for these expenses or received retroactively for expenses of predecessor agencies. 53 of 119 |
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1135 | 1135 | | 1115Pharmaceutical manufacturing companies shall pay such assessed amount multiplied by the ratio |
---|
1136 | 1136 | | 1116of the pharmaceutical manufacturing company’s gross sales of outpatient prescription drugs |
---|
1137 | 1137 | | 1117dispensed in the commonwealth or similar measure determined by the center consistent with |
---|
1138 | 1138 | | 1118applicable federal requirements. |
---|
1139 | 1139 | | 1119 To fund the operations of the licensure of pharmacy benefit managers to the maximum |
---|
1140 | 1140 | | 1120extent allowed by federal law and to the extent that the assessment will not result in any |
---|
1141 | 1141 | | 1121reduction of federal financial participation in Medicaid, the assessed amount for pharmacy |
---|
1142 | 1142 | | 1122benefit managers shall be not less than 25 per cent of the amount appropriated by the general |
---|
1143 | 1143 | | 1123court for the expenses of the center minus amounts collected from: (i) filing fees; (ii) fees and |
---|
1144 | 1144 | | 1124charges generated by the center's publication or dissemination of reports and information; and |
---|
1145 | 1145 | | 1125(iii) federal matching revenues received for these expenses or received retroactively for expenses |
---|
1146 | 1146 | | 1126of predecessor agencies. Pharmacy benefit managers shall pay such assessed amount multiplied |
---|
1147 | 1147 | | 1127by the ratio of the pharmacy benefit manager’s gross revenue related to outpatient prescription |
---|
1148 | 1148 | | 1128drugs dispensed in the commonwealth or similar measure determined by the center consistent |
---|
1149 | 1149 | | 1129with applicable federal requirements. In no event may this assessment, when combined with the |
---|
1150 | 1150 | | 1130assessment of pharmacy benefit managers in section 6 of chapter 6D and the pharmacy benefit |
---|
1151 | 1151 | | 1131manager licensing fee in section 2 of chapter 176Y, exceed the commonwealth’s estimated |
---|
1152 | 1152 | | 1132expense in operating the pharmacy benefit manager licensure program. Each pharmaceutical |
---|
1153 | 1153 | | 1133manufacturing company and each pharmacy benefit manager shall make a preliminary payment |
---|
1154 | 1154 | | 1134to the center on October 1 of each year in an amount equal to 1/2 of the initial year’s and, |
---|
1155 | 1155 | | 1135subsequently, the previous year's total assessment. Thereafter, each pharmaceutical |
---|
1156 | 1156 | | 1136manufacturing company and each pharmacy benefit manager shall pay, within 30 days’ notice 54 of 119 |
---|
1157 | 1157 | | 1137from the center, the balance of the total assessment for the current year as determined by the |
---|
1158 | 1158 | | 1138center. |
---|
1159 | 1159 | | 1139 SECTION 55. Section 8 of said chapter 12C, as so appearing, is hereby amended by |
---|
1160 | 1160 | | 1140inserting after the word “entities”, in line 5, the following words:- , including, but not limited to, |
---|
1161 | 1161 | | 1141private equity firms, real estate investment trusts and management services organizations. |
---|
1162 | 1162 | | 1142 SECTION 56. Said section 8 of said chapter 12C, as so appearing, is hereby further |
---|
1163 | 1163 | | 1143amended by inserting after the word “statements”, in line 23, the following words:- , including |
---|
1164 | 1164 | | 1144the audited financial statements of the parent organization’s out-of-state operations, private |
---|
1165 | 1165 | | 1145equity firms, real estate investment trusts and management services organizations,. |
---|
1166 | 1166 | | 1146 SECTION 57. Said section 8 of said chapter 12C, as so appearing, is hereby further |
---|
1167 | 1167 | | 1147amended by striking out, in line 49, the words “and (6)” and inserting in place thereof the |
---|
1168 | 1168 | | 1148following words:- (6) investments; and (7) information on any relationships with private equity |
---|
1169 | 1169 | | 1149firms, real estate investment trusts and management services organizations; and (8). |
---|
1170 | 1170 | | 1150 SECTION 58. Said chapter 12C is hereby further amended by striking out section 9, as so |
---|
1171 | 1171 | | 1151appearing, and inserting in place thereof the following section:- |
---|
1172 | 1172 | | 1152 Section 9. (a) The center, in consultation with the commission, shall promulgate |
---|
1173 | 1173 | | 1153regulations to require that provider organizations registered under section 11 of chapter 6D |
---|
1174 | 1174 | | 1154annually report the data as the center considers necessary to better protect the public interest in |
---|
1175 | 1175 | | 1155monitoring the financial conditions, organizational structure, business practices, clinical services |
---|
1176 | 1176 | | 1156and market share of each registered provider organization. The center may assess administrative |
---|
1177 | 1177 | | 1157fees on provider organizations in an amount to help defray the center's costs in complying with 55 of 119 |
---|
1178 | 1178 | | 1158this section. The center may specify in regulations uniform reporting standards and reporting |
---|
1179 | 1179 | | 1159thresholds as it determines necessary. |
---|
1180 | 1180 | | 1160 (b) The center shall require registered provider organizations to report information |
---|
1181 | 1181 | | 1161necessary to achieve the goals described in subsection (a), which may include, but shall not be |
---|
1182 | 1182 | | 1162limited to: (i) organizational charts showing the ownership, governance and operational structure |
---|
1183 | 1183 | | 1163of the provider organization, including any clinical affiliations and community advisory boards; |
---|
1184 | 1184 | | 1164(ii) the number of affiliated health care professional full-time equivalents by license type, |
---|
1185 | 1185 | | 1165specialty, name and address of practice locations and whether the professional is employed by |
---|
1186 | 1186 | | 1166the organization; (iii) the name and address of licensed facilities by license number, license type |
---|
1187 | 1187 | | 1167and capacity in each major service category; (iv) the name, address and capacity of all other |
---|
1188 | 1188 | | 1168locations where the provider organization, or any of its affiliates, delivers health care services, |
---|
1189 | 1189 | | 1169including those services listed in paragraph (4) of subsection (a) of section 22 of chapter 6D; (v) |
---|
1190 | 1190 | | 1170counts and capacity estimates of health care equipment as defined by the center, including |
---|
1191 | 1191 | | 1171imaging equipment; (vi) a comprehensive financial statement, including information on parent |
---|
1192 | 1192 | | 1172entities, including their out-of-state operations, and corporate affiliates, including private equity |
---|
1193 | 1193 | | 1173firms, real estate investment trusts and management services organizations, as applicable, and |
---|
1194 | 1194 | | 1174including details regarding annual costs, annual receipts, realized capital gains and losses, |
---|
1195 | 1195 | | 1175accumulated surplus and accumulated reserves; (vii) information on stop-loss insurance and any |
---|
1196 | 1196 | | 1176non-fee-for-service payment arrangements; (viii) information on clinical quality, care |
---|
1197 | 1197 | | 1177coordination and patient referral practices; (ix) information regarding expenditures and funding |
---|
1198 | 1198 | | 1178sources for payroll, teaching, research, advertising, taxes or payments-in-lieu-of-taxes and other |
---|
1199 | 1199 | | 1179non-clinical functions; (x) information regarding charitable care and community benefit |
---|
1200 | 1200 | | 1180programs; (xi) for any risk-bearing provider organization, a certificate from the division of 56 of 119 |
---|
1201 | 1201 | | 1181insurance under chapter 176U; (xii) information regarding other assets and liabilities that may |
---|
1202 | 1202 | | 1182affect the financial condition of the provider organization or the provider organization’s |
---|
1203 | 1203 | | 1183facilities, including, but not limited to, real estate sale-leaseback arrangements with real estate |
---|
1204 | 1204 | | 1184investment trusts; and (xiii) such other information as the center considers appropriate as set |
---|
1205 | 1205 | | 1185forth in the center's regulations; provided, however, that the center shall coordinate with the |
---|
1206 | 1206 | | 1186commission and the division of insurance to obtain information directly from the commission; |
---|
1207 | 1207 | | 1187provided further, that the center shall consider the administrative burden of reporting when |
---|
1208 | 1208 | | 1188developing reporting requirements. The center may, in consultation with the division of |
---|
1209 | 1209 | | 1189insurance and the commission, merge similar reporting requirements where appropriate. The |
---|
1210 | 1210 | | 1190center, in its discretion, may specify additional data elements in a given reporting year to support |
---|
1211 | 1211 | | 1191the development of the state health plan or the focused assessments defined in said section 22 of |
---|
1212 | 1212 | | 1192said chapter 6D. |
---|
1213 | 1213 | | 1193 (c) Annual reporting shall be in a form provided by the center. The center shall |
---|
1214 | 1214 | | 1194promulgate regulations that define criteria for waivers from certain annual reporting |
---|
1215 | 1215 | | 1195requirements under this section. Criteria for waivers may include operational size of the provider |
---|
1216 | 1216 | | 1196organization, the provider organization's annual net patient service revenue, the degree of risk |
---|
1217 | 1217 | | 1197assumed by the provider organization and other criteria as the center considers appropriate. |
---|
1218 | 1218 | | 1198 (d) Notwithstanding the annual reporting requirements under this section, the center may |
---|
1219 | 1219 | | 1199require in writing, at any time, additional information that is reasonable and necessary to |
---|
1220 | 1220 | | 1200determine the financial condition, organizational structure, business practices, clinical services or |
---|
1221 | 1221 | | 1201market share of a registered provider organization. 57 of 119 |
---|
1222 | 1222 | | 1202 (e) The center shall develop and maintain an inventory of health care resources on its |
---|
1223 | 1223 | | 1203website in a form usable by the public; provided, that the extracts must include information on |
---|
1224 | 1224 | | 1204the geographic distribution of clinicians, facilities, equipment or any other health care resources. |
---|
1225 | 1225 | | 1205Such inventory shall be derived from all available data, including, but not limited to, data |
---|
1226 | 1226 | | 1206collected under this section and data collected by other state agencies. Agencies that license, |
---|
1227 | 1227 | | 1207register, regulate or otherwise collect cost, quality or other data concerning health care resources |
---|
1228 | 1228 | | 1208shall provide the center and the commission such data and information necessary to develop and |
---|
1229 | 1229 | | 1209maintain the inventory required by this this section. |
---|
1230 | 1230 | | 1210 (f) The center may enter into interagency agreements with the commission and other state |
---|
1231 | 1231 | | 1211agencies to effectuate the goals of this section. |
---|
1232 | 1232 | | 1212 (g)(1) The center shall also collect and analyze such data as it considers necessary to |
---|
1233 | 1233 | | 1213protect the public interest in monitoring financial conditions of registered provider organizations |
---|
1234 | 1234 | | 1214and compliance with subsection (a) of section 23 of chapter 6D by registered provider |
---|
1235 | 1235 | | 1215organizations with private equity investment. To effectuate this subsection, the center may: (i) |
---|
1236 | 1236 | | 1216modify uniform reporting requirements; (ii) require registered provider organizations with |
---|
1237 | 1237 | | 1217private equity investment to report required information quarterly; (iii) require relevant |
---|
1238 | 1238 | | 1218information from private equity firms and their affiliates; and (iv) communicate confidentially |
---|
1239 | 1239 | | 1219with registered provider organizations as the center deems necessary. |
---|
1240 | 1240 | | 1220 (2) The information shall be analyzed on an industry-wide and provider-specific basis |
---|
1241 | 1241 | | 1221and shall include, but not be limited to: (i) gross and net patient service revenues; (ii) sources of |
---|
1242 | 1242 | | 1222revenue; (iii) total payroll as a per cent of operating expenses and the salary and benefits of the 58 of 119 |
---|
1243 | 1243 | | 1223top 10 highest compensated employees, identified by position description and specialty; and (iv) |
---|
1244 | 1244 | | 1224other relevant measures of financial health or distress. |
---|
1245 | 1245 | | 1225 (3) The center shall publish annual reports and establish a continuing program of |
---|
1246 | 1246 | | 1226investigation and study of financial trends among registered provider organizations, including an |
---|
1247 | 1247 | | 1227analysis of systemic instabilities or inefficiencies that contribute to financial distress. The reports |
---|
1248 | 1248 | | 1228shall include an identification and examination of: (i) registered provider organizations that the |
---|
1249 | 1249 | | 1229center considers to be in financial distress, including any at risk of closing or discontinuing |
---|
1250 | 1250 | | 1230essential health services, as defined by the department of public health under section 51G of |
---|
1251 | 1251 | | 1231chapter 111, as a result of financial distress; and (ii) registered provider organizations with |
---|
1252 | 1252 | | 1232private equity investment that have violated subsection (a) of section 23 of chapter 6D. The |
---|
1253 | 1253 | | 1233center may provide this information in the report it produces pursuant to subsection (c) of section |
---|
1254 | 1254 | | 12348. |
---|
1255 | 1255 | | 1235 (4) The center shall refer to the commission any provider in which a private equity firm |
---|
1256 | 1256 | | 1236has a financial interest that has violated subsection (a) of section 23 of chapter 6D. |
---|
1257 | 1257 | | 1237 SECTION 59. Section 10 of said chapter 12C, as so appearing, is hereby amended by |
---|
1258 | 1258 | | 1238inserting after the word “of”, in line 21, the following words:- communities and purchaser. |
---|
1259 | 1259 | | 1239 SECTION 60. Subsection (b) of said section 10 of chapter 12C, as so appearing, is |
---|
1260 | 1260 | | 1240hereby further amended by striking out clause (8) and inserting in place thereof the following |
---|
1261 | 1261 | | 1241clause:- |
---|
1262 | 1262 | | 1242 (8) relative prices paid to every hospital or physician group in the payer’s network, by |
---|
1263 | 1263 | | 1243type of provider, with hospital inpatient and outpatient prices listed separately and product type, |
---|
1264 | 1264 | | 1244including health maintenance organization and preferred provider organization products. 59 of 119 |
---|
1265 | 1265 | | 1245 SECTION 61. Said subsection (b) of said section 10 of said chapter 12C, as so appearing, |
---|
1266 | 1266 | | 1246is hereby further amended by striking out, in lines 56 to 61, inclusive, the words “and (11) a |
---|
1267 | 1267 | | 1247comparison of relative prices for the payer’s participating health care providers by provider type |
---|
1268 | 1268 | | 1248which shows the average relative price, the extent of variation in price, stated as a percentage, |
---|
1269 | 1269 | | 1249and identifies providers who are paid more than 10 per cent, 15 per cent and 20 per cent above |
---|
1270 | 1270 | | 1250and more than 10 per cent, 15 per cent and 20 per cent below the average relative price” and |
---|
1271 | 1271 | | 1251inserting in place thereof the following words:- (11) information about prescription drug |
---|
1272 | 1272 | | 1252utilization and spending for all covered drugs, including for generic drugs, brand-name drugs and |
---|
1273 | 1273 | | 1253specialty drugs provided in an inpatient or outpatient setting or sold in a retail setting, including, |
---|
1274 | 1274 | | 1254but not limited to, information sufficient to show the: (i) highest utilization drugs, (ii) drugs with |
---|
1275 | 1275 | | 1255the greatest increases in utilization, (iii) drugs that are most impactful on plan spending, net of |
---|
1276 | 1276 | | 1256rebates, (iv) drugs with the highest year-over-year price increases, net of rebates, and (v) drugs |
---|
1277 | 1277 | | 1257with the highest cost per prescription both gross and net of rebates; (12) information on clinical |
---|
1278 | 1278 | | 1258quality, care coordination and patient referral practices; and (13) a comparison of relative prices |
---|
1279 | 1279 | | 1259for the payer’s participating health care providers by provider type, which shows the average |
---|
1280 | 1280 | | 1260relative price and the extent of variation in price and identifies providers who are paid more than |
---|
1281 | 1281 | | 126110 per cent, 15 per cent and 20 per cent above and more than 10 per cent, 15 per cent and 20 per |
---|
1282 | 1282 | | 1262cent below the average relative price. |
---|
1283 | 1283 | | 1263 SECTION 62. Subsection (c) of said section 10 of said chapter 12C, as so appearing. is |
---|
1284 | 1284 | | 1264hereby amended by striking out clause (8) and inserting in place thereof the following clause:- |
---|
1285 | 1285 | | 1265 (8) relative prices paid to every hospital or physician group in the payer’s network, by |
---|
1286 | 1286 | | 1266type of provider, with hospital inpatient and outpatient prices listed separately and product type, |
---|
1287 | 1287 | | 1267including health maintenance organization and preferred provider organization products. 60 of 119 |
---|
1288 | 1288 | | 1268 SECTION 63. Said subsection (c) of said section 10 of said chapter 12C, as so appearing, |
---|
1289 | 1289 | | 1269is hereby further amended by striking out, in lines 99 to 104, inclusive, the words “and (11) a |
---|
1290 | 1290 | | 1270comparison of relative prices for the payer’s participating health care providers by provider type |
---|
1291 | 1291 | | 1271which shows the average relative price, the extent of variation in price, stated as a percentage and |
---|
1292 | 1292 | | 1272identifies providers who are paid more than 10 per cent, 15 per cent and 20 per cent above and |
---|
1293 | 1293 | | 1273more than 10 per cent, 15 per cent and 20 per cent below the average relative price” and inserting |
---|
1294 | 1294 | | 1274in place thereof the following words:- (11) information about prescription drug utilization and |
---|
1295 | 1295 | | 1275spending for all covered drugs, including for generic drugs, brand-name drugs and specialty |
---|
1296 | 1296 | | 1276drugs provided in an inpatient or outpatient setting or sold in a retail setting, including, but not |
---|
1297 | 1297 | | 1277limited to, information sufficient to show the: (i) highest utilization drugs, (ii) drugs with the |
---|
1298 | 1298 | | 1278greatest increases in utilization, (iii) drugs that are most impactful on plan spending, net of |
---|
1299 | 1299 | | 1279rebates, (v) drugs with the highest year-over-year price increases, net of rebates, and (v) drugs |
---|
1300 | 1300 | | 1280with the highest cost per prescription, both gross and net of rebates; (12) information on clinical |
---|
1301 | 1301 | | 1281quality, care coordination and patient referral practices; and (13) a comparison of relative prices |
---|
1302 | 1302 | | 1282for the payer’s participating health care providers by provider type, which shows the average |
---|
1303 | 1303 | | 1283relative price and the extent of variation in price and identifies providers who are paid more than |
---|
1304 | 1304 | | 128410 per cent, 15 per cent and 20 per cent above and more than 10 per cent, 15 per cent and 20 per |
---|
1305 | 1305 | | 1285cent below the average relative price. |
---|
1306 | 1306 | | 1286 SECTION 64. Said chapter 12C is hereby amended by inserting after section 10 the |
---|
1307 | 1307 | | 1287following section:- |
---|
1308 | 1308 | | 1288 Section 10A. (a) The center shall promulgate regulations necessary to ensure the uniform |
---|
1309 | 1309 | | 1289annual reporting of information from pharmacy benefit managers certified under chapter 176Y, |
---|
1310 | 1310 | | 1290including, but not limited to, data from the most recent calendar year detailing: (i) all discounts, 61 of 119 |
---|
1311 | 1311 | | 1291including the total dollar amount and percentage discount and rebates received from a |
---|
1312 | 1312 | | 1292manufacturer for each drug on the pharmacy benefit manager's formularies; (ii) the total dollar |
---|
1313 | 1313 | | 1293amount of all discounts and rebates that are retained by the pharmacy benefit manager for each |
---|
1314 | 1314 | | 1294drug on the pharmacy benefit manager's formularies; (iii) actual total reimbursement amounts for |
---|
1315 | 1315 | | 1295each drug the pharmacy benefit manager pays retail pharmacies after all direct and indirect |
---|
1316 | 1316 | | 1296administrative and other fees that have been retrospectively charged to the pharmacies are |
---|
1317 | 1317 | | 1297applied; (iv) the negotiated price health plans pay the pharmacy benefit manager for each drug |
---|
1318 | 1318 | | 1298on the pharmacy benefit manager's formularies; (v) the amount, terms and conditions relating to |
---|
1319 | 1319 | | 1299copayments, reimbursement options and other payments or fees associated with a prescription |
---|
1320 | 1320 | | 1300drug benefit plan; and (vi) disclosure of any ownership interest the pharmacy benefit manager |
---|
1321 | 1321 | | 1301has in a pharmacy or health plan with which it conducts business or any corporate affiliation |
---|
1322 | 1322 | | 1302between the pharmacy benefit manager and the pharmacy or health plan with which it conducts |
---|
1323 | 1323 | | 1303business; provided, however, that the center may examine or audit the financial records of a |
---|
1324 | 1324 | | 1304pharmacy benefit manager for purposes of ensuring the information submitted pursuant to |
---|
1325 | 1325 | | 1305regulations promulgated under this section is accurate. |
---|
1326 | 1326 | | 1306 (b) The center shall analyze the information and data collected under subsection (a) and |
---|
1327 | 1327 | | 1307shall publish an annual report summarizing, at minimum, the information collected under said |
---|
1328 | 1328 | | 1308subsection (a) and comparing the information as it relates to pharmacy benefit managers certified |
---|
1329 | 1329 | | 1309under chapter 176Y with respect to drugs provided to residents of the commonwealth. |
---|
1330 | 1330 | | 1310 (c) Except as specifically provided otherwise by the center or under this chapter, |
---|
1331 | 1331 | | 1311pharmacy benefit manager data collected by the center under this section shall not be a public |
---|
1332 | 1332 | | 1312record under clause Twenty-sixth of section 7 of chapter 4 or chapter 66. The center may 62 of 119 |
---|
1333 | 1333 | | 1313confidentially provide pharmacy benefit manager data collected by the center under this section |
---|
1334 | 1334 | | 1314to the health policy commission. |
---|
1335 | 1335 | | 1315 SECTION 65. Said chapter 12C is hereby further amended by striking out section 11, as |
---|
1336 | 1336 | | 1316appearing in the 2022 Official Edition, and inserting in place thereof the following section:- |
---|
1337 | 1337 | | 1317 Section 11. The center shall ensure the timely reporting of information required under |
---|
1338 | 1338 | | 1318sections 8 to 10, inclusive. The center shall notify entities required to submit data under this |
---|
1339 | 1339 | | 1319chapter of any applicable reporting deadlines. The center shall notify, in writing, an entity, other |
---|
1340 | 1340 | | 1320than a public payer required to submit data under this chapter, which has failed to meet a |
---|
1341 | 1341 | | 1321reporting deadline and that failure to respond within 2 weeks of the receipt of the notice may |
---|
1342 | 1342 | | 1322result in penalties. The center may assess a penalty against an entity other than a public health |
---|
1343 | 1343 | | 1323care payer required to submit data under this chapter that fails, without just cause, to provide the |
---|
1344 | 1344 | | 1324requested information within 2 weeks following receipt of the written notice required under this |
---|
1345 | 1345 | | 1325paragraph, of not more than $25,000 per week for each week of delay after the 2-week period |
---|
1346 | 1346 | | 1326following the reporting entity’s receipt of the written notice. Amounts collected under this |
---|
1347 | 1347 | | 1327section shall be deposited in the Healthcare Payment Reform Fund, established under section 100 |
---|
1348 | 1348 | | 1328of 194 of the acts of 2011. The center shall notify the commission and the department of public |
---|
1349 | 1349 | | 1329health if a provider or provider organization fails to timely report in accordance with this section, |
---|
1350 | 1350 | | 1330or if the center has assessed a penalty under this section. Such notification shall be considered by |
---|
1351 | 1351 | | 1331the commission in a cost and market impact review under section 13 of chapter 6D, and by the |
---|
1352 | 1352 | | 1332department in determining licensure and suitability in accordance with section 51 of chapter 111 |
---|
1353 | 1353 | | 1333and for a determination of need under section 25C of said chapter 111. 63 of 119 |
---|
1354 | 1354 | | 1334 SECTION 66. Section 12 of said chapter 12C, as so appearing, is hereby amended by |
---|
1355 | 1355 | | 1335adding the following subsection:- |
---|
1356 | 1356 | | 1336 (c) Notwithstanding any general or special law to the contrary, a provider, private health |
---|
1357 | 1357 | | 1337care payer, public health care payer, agency, department, division, commission, board, authority |
---|
1358 | 1358 | | 1338or other public or quasi-public entity in the commonwealth that collects patient information, |
---|
1359 | 1359 | | 1339including personal data as defined in section 1 of chapter 66A, shall, upon a request from the |
---|
1360 | 1360 | | 1340center, provide such data to the center for any purpose consistent with this chapter; provided, |
---|
1361 | 1361 | | 1341however, that the disclosure of such information shall be in compliance with federal law. |
---|
1362 | 1362 | | 1342 SECTION 67. Said chapter 12C is hereby further amended by striking out section 14, as |
---|
1363 | 1363 | | 1343so appearing, and inserting in place thereof the following section:- |
---|
1364 | 1364 | | 1344 Section 14. (a)(1) Not later than March 1 in each even-numbered year, the center, in |
---|
1365 | 1365 | | 1345consultation with the statewide advisory committee established pursuant to subsection (c), shall |
---|
1366 | 1366 | | 1346establish a standard set of measures of health care provider quality and health system |
---|
1367 | 1367 | | 1347performance, hereinafter referred to as the “standard quality measure set”, for use in: (i) contracts |
---|
1368 | 1368 | | 1348between payers, including between the commonwealth and carriers and between health care |
---|
1369 | 1369 | | 1349providers, provider organizations and accountable care organizations, which incorporate quality |
---|
1370 | 1370 | | 1350measures into payment terms, including the designation of a set of core measures and a set of |
---|
1371 | 1371 | | 1351non-core measures; (ii) assigning tiers to health care providers in the design of any health plan; |
---|
1372 | 1372 | | 1352(iii) consumer transparency websites and other methods of providing consumer information; (iv) |
---|
1373 | 1373 | | 1353monitoring system-wide performance; and (v) reducing provider administrative burden related to |
---|
1374 | 1374 | | 1354quality measure reporting. 64 of 119 |
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1375 | 1375 | | 1355 (2) The standard quality measure set shall designate: (i) core measures that shall be used |
---|
1376 | 1376 | | 1356in contracts that incorporate quality measures into payment terms between payers, including the |
---|
1377 | 1377 | | 1357commonwealth and carriers, and health care providers, including provider organizations and |
---|
1378 | 1378 | | 1358accountable care organizations, and shall meet the core criteria set by the statewide advisory |
---|
1379 | 1379 | | 1359committee pursuant to paragraph (3) of subsection (c); and (ii) a menu of non-core measures that |
---|
1380 | 1380 | | 1360may be used in such contracts. The standard quality measure set shall allow for innovation and |
---|
1381 | 1381 | | 1361the development of outcome measures for quality and safety. If the standard quality measure set |
---|
1382 | 1382 | | 1362established by the center differs from the recommendations of the statewide advisory committee, |
---|
1383 | 1383 | | 1363the center shall issue a written report detailing each area of disagreement and the rationale for the |
---|
1384 | 1384 | | 1364center’s decision. |
---|
1385 | 1385 | | 1365 (b) The center shall develop uniform reporting requirements for the standard quality |
---|
1386 | 1386 | | 1366measure set for each health care provider facility, medical group or provider group in the |
---|
1387 | 1387 | | 1367commonwealth; provided, however, that the center shall prioritize the development of uniform |
---|
1388 | 1388 | | 1368reporting requirements for primary care and behavioral health providers; and provided further, |
---|
1389 | 1389 | | 1369that the uniform reporting requirements shall not increase provider administrative burden related |
---|
1390 | 1390 | | 1370to quality measure reporting. |
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1391 | 1391 | | 1371 (c)(1) The center shall convene a statewide advisory committee which shall make |
---|
1392 | 1392 | | 1372recommendations for the standard quality measure set to: (i) ensure consistency in the use of |
---|
1393 | 1393 | | 1373quality and safety measures in contracts between payers, including the commonwealth and |
---|
1394 | 1394 | | 1374carriers, and health care providers in the commonwealth; (ii) ensure consistency in methods for |
---|
1395 | 1395 | | 1375the assignment of tiers to providers in the design of any health plan; (iii) improve quality and |
---|
1396 | 1396 | | 1376safety of care; (iv) improve transparency for consumers and employers; (v) improve health 65 of 119 |
---|
1397 | 1397 | | 1377system monitoring and oversight by relevant state agencies; and (vi) reduce administrative |
---|
1398 | 1398 | | 1378burdens. |
---|
1399 | 1399 | | 1379 (2) The statewide advisory committee shall consist of commissioner of insurance or a |
---|
1400 | 1400 | | 1380designee, who shall serve as co-chair; the executive director of the health policy commission, or |
---|
1401 | 1401 | | 1381their designee, who shall serve as co-chair; the executive director of the center; the executive |
---|
1402 | 1402 | | 1382director of the Betsy Lehman center for patient safety and medical error reduction; the executive |
---|
1403 | 1403 | | 1383director of the group insurance commission; the secretary of elder affairs; the assistant secretary |
---|
1404 | 1404 | | 1384for MassHealth; the commissioner of the department of public health; the commissioner of the |
---|
1405 | 1405 | | 1385department of mental health; and 11 members who shall be appointed by the governor, 1 of |
---|
1406 | 1406 | | 1386whom shall be a representative of Massachusetts Health and Hospital Association, Inc., 1 of |
---|
1407 | 1407 | | 1387whom shall be a representative of the Massachusetts League of Community Health Centers, Inc., |
---|
1408 | 1408 | | 13881 of whom shall be a representative the Massachusetts Medical Society, 1 of whom shall be a |
---|
1409 | 1409 | | 1389registered nurse licensed to practice in the commonwealth who practices in a patient care setting, |
---|
1410 | 1410 | | 13901 of whom shall be a representative of a labor organization representing health care workers, 1 of |
---|
1411 | 1411 | | 1391whom shall be a behavioral health provider, 1 of whom shall be a long-term supports and |
---|
1412 | 1412 | | 1392services provider, 1 of whom shall be a representative of Blue Cross and Blue Shield of |
---|
1413 | 1413 | | 1393Massachusetts, Inc., 1 of whom shall be a representative of Massachusetts Association of Health |
---|
1414 | 1414 | | 1394Plans, Inc., 1 of whom shall be a representative of a specialty pediatric provider and 1 of whom |
---|
1415 | 1415 | | 1395shall be a representative of consumers. Members appointed to the statewide advisory committee |
---|
1416 | 1416 | | 1396shall have experience with and expertise in health care quality measurement. |
---|
1417 | 1417 | | 1397 (3) The statewide advisory committee shall meet quarterly to develop recommendations |
---|
1418 | 1418 | | 1398for the core measure and non-core measures to be adopted in the standard quality measure set for |
---|
1419 | 1419 | | 1399use in: (i) contracts between payers, including the commonwealth and carriers, and health care 66 of 119 |
---|
1420 | 1420 | | 1400providers, provider organizations and accountable care organizations, including the designation |
---|
1421 | 1421 | | 1401of a set of core measures and a set of non-core measures; (ii) assigning tiers to health care |
---|
1422 | 1422 | | 1402providers in the design of any health plan; (iii) consumer transparency websites and other |
---|
1423 | 1423 | | 1403methods of providing consumer information; (iv) monitoring system-wide performance; and (v) |
---|
1424 | 1424 | | 1404reducing provider administrative burdens related to quality measure reporting. |
---|
1425 | 1425 | | 1405 (4) In developing its recommendations for the standard quality measure set, the statewide |
---|
1426 | 1426 | | 1406advisory committee shall incorporate recognized quality and safety measures including, but not |
---|
1427 | 1427 | | 1407limited to, measures used by the Centers for Medicare and Medicaid Services, the group |
---|
1428 | 1428 | | 1408insurance commission, carriers and providers and provider organizations in the commonwealth |
---|
1429 | 1429 | | 1409and other states, as well as other valid measures of health care provider performance and |
---|
1430 | 1430 | | 1410outcomes, including patient-reported outcomes and functional status, patient experience, health |
---|
1431 | 1431 | | 1411disparities and population health. The statewide advisory committee shall consider measures |
---|
1432 | 1432 | | 1412applicable to primary care providers, specialists, hospitals, provider organizations, accountable |
---|
1433 | 1433 | | 1413care organizations, oral health providers and other types of providers and measures applicable to |
---|
1434 | 1434 | | 1414different patient populations. |
---|
1435 | 1435 | | 1415 (5) Not later than January 1 in each even-numbered year, the statewide advisory |
---|
1436 | 1436 | | 1416committee shall submit to the center its recommendations on the core measures and non-core |
---|
1437 | 1437 | | 1417measures to be adopted, changed or updated by the center in the standard quality measure set, |
---|
1438 | 1438 | | 1418along with a report in support of its recommendations. |
---|
1439 | 1439 | | 1419 SECTION 68. Section 15 of said chapter 12C, as so appearing, is hereby amended by |
---|
1440 | 1440 | | 1420striking out, in line 4, the word “injury” and inserting in place thereof the following word:- harm. 67 of 119 |
---|
1441 | 1441 | | 1421 SECTION 69. Said section 15 of said chapter 12C, as so appearing, is hereby further |
---|
1442 | 1442 | | 1422amended by striking out the definition of “Board” and inserting in place thereof the following 3 |
---|
1443 | 1443 | | 1423definitions:- |
---|
1444 | 1444 | | 1424 “Agency”, an agency of the executive branch of the commonwealth including, but not |
---|
1445 | 1445 | | 1425limited to, a constitutional or other office, executive office, department, division, bureau, board, |
---|
1446 | 1446 | | 1426commission or committee thereof, or any authority created by the general court to serve a public |
---|
1447 | 1447 | | 1427purpose, having either statewide or local jurisdiction. |
---|
1448 | 1448 | | 1428 “Board”, the patient safety and medical errors reduction board. |
---|
1449 | 1449 | | 1429 “Healthcare-associated infection”, an infection that a patient acquires during the course of |
---|
1450 | 1450 | | 1430receiving treatment for other conditions within a health care setting. |
---|
1451 | 1451 | | 1431 SECTION 70. Said section 15 of said chapter 12C, as so appearing, is hereby further |
---|
1452 | 1452 | | 1432amended by inserting after the definition of “Patient safety” the following definition:- |
---|
1453 | 1453 | | 1433 “Patient safety information”, data and information related to patient safety, including |
---|
1454 | 1454 | | 1434adverse events, incidents, medical errors or health care-associated infections, that is collected or |
---|
1455 | 1455 | | 1435maintained by agencies. |
---|
1456 | 1456 | | 1436 SECTION 71. Said section 15 of said chapter 12C, as so appearing, is hereby further |
---|
1457 | 1457 | | 1437amended by striking out subsection (f) and inserting in place thereof the following 3 |
---|
1458 | 1458 | | 1438subsections:- |
---|
1459 | 1459 | | 1439 (f) Notwithstanding any general or special law to the contrary, the Lehman center and |
---|
1460 | 1460 | | 1440any agency, provider organization, department, division, commission, board, authority or other |
---|
1461 | 1461 | | 1441public or quasi-public entity in the commonwealth that collects or maintains patient safety 68 of 119 |
---|
1462 | 1462 | | 1442information may transmit such information, including personal data as defined in section 1 of |
---|
1463 | 1463 | | 1443chapter 66A, to each other, and shall transmit such information to the Lehman center upon |
---|
1464 | 1464 | | 1444request from the Lehman center; provided, however, that transmission of such information shall |
---|
1465 | 1465 | | 1445be governed by an agreement, which may be an interagency service agreement, between the |
---|
1466 | 1466 | | 1446party transmitting the information and the Lehman center; provided further, that such agreement |
---|
1467 | 1467 | | 1447shall provide for any safeguards necessary to protect the privacy and security of the information; |
---|
1468 | 1468 | | 1448and provided further, that the transmission of such information shall be in compliance with |
---|
1469 | 1469 | | 1449federal law. |
---|
1470 | 1470 | | 1450 (g) The Lehman center may adopt rules and regulations necessary to carry out the |
---|
1471 | 1471 | | 1451purpose of this section. The Lehman center may contract with any federal, state or municipal |
---|
1472 | 1472 | | 1452entity or other public institution or with any private individual, partnership, firm, corporation, |
---|
1473 | 1473 | | 1453association or other entity to manage its affairs or carry out the purpose of this section. |
---|
1474 | 1474 | | 1454 (h) The Lehman center shall report annually to the joint committee on health care |
---|
1475 | 1475 | | 1455financing regarding the progress made in improving patient safety and medical error reduction. |
---|
1476 | 1476 | | 1456The Lehman center may seek federal and foundation support to supplement state resources to |
---|
1477 | 1477 | | 1457carry out the Lehman center’s patient safety and medical error reduction goals. |
---|
1478 | 1478 | | 1458 SECTION 72. Section 16 of said chapter 12C, as so appearing, is hereby amended by |
---|
1479 | 1479 | | 1459inserting after the word “publish”, in line 1, the following words:- , for the most recently |
---|
1480 | 1480 | | 1460concluded benchmark cycle, . |
---|
1481 | 1481 | | 1461 SECTION 73. Said section 16 of said chapter 12C, as so appearing, is hereby further |
---|
1482 | 1482 | | 1462amended by inserting after the word “submitted”, in line 2, the following words:- for that |
---|
1483 | 1483 | | 1463benchmark cycle . 69 of 119 |
---|
1484 | 1484 | | 1464 SECTION 74. Said section 16 of said chapter 12C, as so appearing, is hereby further |
---|
1485 | 1485 | | 1465amended by striking out, in line 7, the word “benchmark” and inserting in place thereof the |
---|
1486 | 1486 | | 1466following words:- and affordability benchmarks. |
---|
1487 | 1487 | | 1467 SECTION 75. Said section 16 of said chapter 12C, as so appearing, is hereby further |
---|
1488 | 1488 | | 1468amended by striking out, in line 8, the words “section 9” and inserting in place thereof the |
---|
1489 | 1489 | | 1469following words:- sections 9 and 9A. |
---|
1490 | 1490 | | 1470 SECTION 76. Said section 16 of said chapter 12C, as so appearing, is hereby further |
---|
1491 | 1491 | | 1471amended by striking out, in line 43, the words “and (12)” and inserting in place thereof the |
---|
1492 | 1492 | | 1472following words:- (12) a standard set of measures of health care affordability in the |
---|
1493 | 1493 | | 1473commonwealth, including family health care expenditures and an annual index of how such |
---|
1494 | 1494 | | 1474health care costs compare to the health care affordability benchmark set under section 9A of |
---|
1495 | 1495 | | 1475chapter 6D; and (13). |
---|
1496 | 1496 | | 1476 SECTION 77. Said chapter 12C of the General Laws is hereby amended by striking out |
---|
1497 | 1497 | | 1477sections 17 and 18, as so appearing, and inserting in place thereof the following 2 sections:- |
---|
1498 | 1498 | | 1478 Section 17. The attorney general may review and analyze any information submitted to |
---|
1499 | 1499 | | 1479the center by a provider, provider organization, private equity firm, real estate investment trust, |
---|
1500 | 1500 | | 1480management services organization, pharmaceutical manufacturing company, pharmacy benefit |
---|
1501 | 1501 | | 1481manager or payer pursuant to sections 8, 9 and 10 of this chapter, and to the commission under |
---|
1502 | 1502 | | 1482section 8 of chapter 6D. The attorney general may require that such entities produce documents, |
---|
1503 | 1503 | | 1483answer interrogatories and provide testimony under oath related to health care costs and cost |
---|
1504 | 1504 | | 1484trends, factors that contribute to cost growth within the commonwealth’s health care system and |
---|
1505 | 1505 | | 1485the relationship between provider costs and payer premium rates. The attorney general shall keep 70 of 119 |
---|
1506 | 1506 | | 1486confidential all nonpublic information and documents obtained under this section and shall not |
---|
1507 | 1507 | | 1487disclose the information or documents to any person without the consent of the entity that |
---|
1508 | 1508 | | 1488produced the information or documents; provided, however, that the attorney general may |
---|
1509 | 1509 | | 1489disclose such information or documents during (i) the annual hearing conducted under section 8 |
---|
1510 | 1510 | | 1490of chapter 6D, (ii) a rate hearing before the health insurance bureau, or (iii) in a case brought by |
---|
1511 | 1511 | | 1491the attorney general, if the attorney general believes that such disclosure will promote the health |
---|
1512 | 1512 | | 1492care cost containment goals of the commonwealth and that the disclosure would be in the public |
---|
1513 | 1513 | | 1493interest after taking into account any privacy, trade secret or anti-competitive considerations. The |
---|
1514 | 1514 | | 1494confidential information and documents shall not be public records and shall be exempt from |
---|
1515 | 1515 | | 1495disclosure under clause Twenty-sixth of section 7 of chapter 4 or section 10 of chapter 66. |
---|
1516 | 1516 | | 1496 Section 18. (a) The center shall perform ongoing analysis of data it receives under this |
---|
1517 | 1517 | | 1497chapter to identify any health care entity whose: (1) contribution to health care spending levels |
---|
1518 | 1518 | | 1498and growth, including but not limited to, spending levels and growth as measured by health- |
---|
1519 | 1519 | | 1499status adjusted total medical expense or total medical expense, is considered excessive and who |
---|
1520 | 1520 | | 1500threaten the ability of the state to meet the health care cost growth benchmark established by the |
---|
1521 | 1521 | | 1501commission under section 9 of chapter 6D; provided further, that the center shall identify cohorts |
---|
1522 | 1522 | | 1502for similar health care entities and establish differential standards for excessive growth rates |
---|
1523 | 1523 | | 1503within the health care cost growth benchmark established by the commission under section 9 of |
---|
1524 | 1524 | | 1504chapter 6D, based on factors which may include, but are not limited to, a health care entity’s |
---|
1525 | 1525 | | 1505spending, pricing levels and payer mix; or (2) data is not submitted to the center in a proper, |
---|
1526 | 1526 | | 1506timely or complete manner. |
---|
1527 | 1527 | | 1507 (b) The center shall confidentially provide a list of the health care entities to the |
---|
1528 | 1528 | | 1508commission such that the commission may pursue further action under section 10 of chapter 6D. 71 of 119 |
---|
1529 | 1529 | | 1509Confidential referrals under this section shall not preclude the center from using its authority to |
---|
1530 | 1530 | | 1510assess penalties for noncompliance under section 11. |
---|
1531 | 1531 | | 1511 SECTION 78. Section 10 of chapter 13 of the General Laws, as so appearing, is hereby |
---|
1532 | 1532 | | 1512amended by striking out the last paragraph and inserting in place thereof the following |
---|
1533 | 1533 | | 1513paragraph:- |
---|
1534 | 1534 | | 1514 The board may: (i) adopt, amend and rescind such rules and regulations as it deems |
---|
1535 | 1535 | | 1515necessary to carry out this chapter subject to the approval of the commissioner of public health; |
---|
1536 | 1536 | | 1516(ii) make contracts and arrangements for the performance of administrative and similar services |
---|
1537 | 1537 | | 1517required or appropriate in the performance of the duties of the board; and (iii) adopt and make |
---|
1538 | 1538 | | 1518public rules of procedure and other regulations not inconsistent with other provisions of the |
---|
1539 | 1539 | | 1519General Laws. The commissioner of public health shall appoint an executive director and a legal |
---|
1540 | 1540 | | 1520counsel for the board. |
---|
1541 | 1541 | | 1521 SECTION 79. Said chapter 13 is hereby further amended by striking out section 10A, as |
---|
1542 | 1542 | | 1522so appearing, and inserting in place thereof the following section:- |
---|
1543 | 1543 | | 1523 Section 10A. The commissioner of public health shall review and approve any rule or |
---|
1544 | 1544 | | 1524regulation proposed by the board of registration in medicine pursuant to section 10. Such rule or |
---|
1545 | 1545 | | 1525regulation shall be deemed disapproved unless approved within 60 days of submission to the |
---|
1546 | 1546 | | 1526commissioner pursuant to said section 10. |
---|
1547 | 1547 | | 1527 SECTION 80. Chapter 26 of the General Laws is hereby amended by striking out section |
---|
1548 | 1548 | | 15287A, as so appearing, and inserting in place thereof the following section:- 72 of 119 |
---|
1549 | 1549 | | 1529 Section 7A. (a) As used in this section, the following words shall, unless the context |
---|
1550 | 1550 | | 1530clearly requires otherwise, have the following meanings:- |
---|
1551 | 1551 | | 1531 “Bureau”, health insurance bureau. |
---|
1552 | 1552 | | 1532 “Deputy commissioner”, the deputy commissioner of the health insurance bureau. |
---|
1553 | 1553 | | 1533 “Health benefit plan”, any individual, general, blanket or group policy of health, accident |
---|
1554 | 1554 | | 1534and sickness insurance issued by an insurer licensed under chapter 175; an individual or group |
---|
1555 | 1555 | | 1535hospital service plan issued by a non-profit hospital service corporation under chapter 176A; an |
---|
1556 | 1556 | | 1536individual or group medical service plan issued by a nonprofit medical service corporation under |
---|
1557 | 1557 | | 1537chapter 176B; an individual or group health maintenance contract issued by a health maintenance |
---|
1558 | 1558 | | 1538organization under chapter 176G, and a dental service plan offered by a dental service |
---|
1559 | 1559 | | 1539corporation under chapter 176E. Health benefit plans shall not include: (i) accident only, credit |
---|
1560 | 1560 | | 1540only, limited scope vision if offered separately; (ii) hospital indemnity insurance policies that |
---|
1561 | 1561 | | 1541provide a benefit to be paid to an insured or a dependent, including the spouse of an insured, on |
---|
1562 | 1562 | | 1542the basis of a hospitalization of the insured or a dependent, that are sold as a supplement and not |
---|
1563 | 1563 | | 1543as a substitute for a health benefit plan and that meet any requirements set by the commissioner |
---|
1564 | 1564 | | 1544by regulation; (iii) disability income insurance; (iv) coverage issued as a supplement to liability |
---|
1565 | 1565 | | 1545insurance; (v) specified disease insurance that is purchased as a supplement and not as a |
---|
1566 | 1566 | | 1546substitute for a health plan and meets any requirements the commissioner by regulation may set; |
---|
1567 | 1567 | | 1547(vi) insurance arising out of a workers' compensation law or similar law; (vii) automobile |
---|
1568 | 1568 | | 1548medical payment insurance; (viii) insurance under which benefits are payable with or without |
---|
1569 | 1569 | | 1549regard to fault and which is statutorily required to be contained in a liability insurance policy or |
---|
1570 | 1570 | | 1550equivalent self-insurance; (ix) long-term care if offered separately; (x) coverage supplemental to 73 of 119 |
---|
1571 | 1571 | | 1551the coverage provided under 10 U.S.C. 55 if offered as a separate insurance policy; (xi) travel |
---|
1572 | 1572 | | 1552insurance; or (xii) any policy subject to chapter 176K or any similar policies issued on a group |
---|
1573 | 1573 | | 1553basis, Medicare Advantage plans or Medicare Prescription drug plans. A health plan issued, |
---|
1574 | 1574 | | 1554renewed or delivered within or without the commonwealth to an individual who is enrolled in a |
---|
1575 | 1575 | | 1555qualifying student health insurance program under section 18 of chapter 15A shall not be |
---|
1576 | 1576 | | 1556considered a health plan for the purposes of this chapter and shall be governed by said chapter |
---|
1577 | 1577 | | 155715A; provided, however, that travel insurance for the purpose of this chapter is insurance |
---|
1578 | 1578 | | 1558coverage for personal risks incident to planned travel, including, but not limited to: (A) |
---|
1579 | 1579 | | 1559interruption or cancellation of trip or event; (B) loss of baggage or personal effects; (C) damages |
---|
1580 | 1580 | | 1560to accommodations or rental vehicles; or (D) sickness, accident, disability or death occurring |
---|
1581 | 1581 | | 1561during travel, provided, however, that the health benefits are not offered on a stand-alone basis |
---|
1582 | 1582 | | 1562and are incidental to other coverages; and provided further, that the term “travel insurance” shall |
---|
1583 | 1583 | | 1563not include major medical plans, which provide comprehensive medical protection for travelers |
---|
1584 | 1584 | | 1564with trips lasting 6 months or longer, including for example, those working overseas as ex-patriot |
---|
1585 | 1585 | | 1565or military personnel being deployed. |
---|
1586 | 1586 | | 1566 “Rate review”, any examination performed by the deputy commissioner of the aggregate |
---|
1587 | 1587 | | 1567rates of payment pursuant to sections 5, 6 and 10 of chapter 176A; section 4 of chapter 176B; |
---|
1588 | 1588 | | 1568section 16 of chapter 176G; section 6 of chapter 176J; and section 7 of chapter 176K. |
---|
1589 | 1589 | | 1569 (b) There shall be within the division of insurance a health insurance bureau overseen by |
---|
1590 | 1590 | | 1570a deputy commissioner, whose duties shall include, but not be limited to, rate review of premium |
---|
1591 | 1591 | | 1571rates for health benefit plans offered, issued or renewed in the commonwealth, administration of |
---|
1592 | 1592 | | 1572the division's statutory and regulatory authority for oversight of the small group and individual |
---|
1593 | 1593 | | 1573health insurance market, oversight of affordable health plans, including coverage for young 74 of 119 |
---|
1594 | 1594 | | 1574adults, as well as the dissemination of appropriate information to consumers about health |
---|
1595 | 1595 | | 1575insurance coverage and access to affordable products. The deputy commissioner shall: (i) protect |
---|
1596 | 1596 | | 1576the interests of consumers of health insurance; (ii) encourage fair treatment of health care |
---|
1597 | 1597 | | 1577providers by health insurers; (iii) enhance equity, access, quality and affordability in the health |
---|
1598 | 1598 | | 1578care system; (iv) guard the solvency of health insurers; (v) work cooperatively with the health |
---|
1599 | 1599 | | 1579policy commission and the center for health information and analysis to monitor health care |
---|
1600 | 1600 | | 1580spending; and (vi) consider affordability of health insurance products during rate review. |
---|
1601 | 1601 | | 1581 (c) The deputy commissioner shall develop affordability standards to consider during rate |
---|
1602 | 1602 | | 1582review; provided, however, that the deputy commissioner’s review of a carrier’s rates shall |
---|
1603 | 1603 | | 1583adhere to principles of solvency and actuarial soundness. Such standards shall consider factors |
---|
1604 | 1604 | | 1584including, but not limited to: (i) affordability for consumers, including the totality of costs paid |
---|
1605 | 1605 | | 1585by consumers of health insurance for covered benefits including, but not limited to, the enrollee’s |
---|
1606 | 1606 | | 1586share of premium, out-of-pocket maximum amounts, deductibles, copays, coinsurance and other |
---|
1607 | 1607 | | 1587forms of cost sharing for health insurance coverage; (ii) affordability for purchasers, including |
---|
1608 | 1608 | | 1588the totality of costs paid by purchasers of health insurance including, but not limited to, premium |
---|
1609 | 1609 | | 1589costs, actuarial value of coverage for covered benefits and the value delivered on health care |
---|
1610 | 1610 | | 1590spending in terms of improved quality and cost efficiency; and (iii) the impact of proposed rates |
---|
1611 | 1611 | | 1591on the commonwealth’s performance against the health care cost growth benchmark established |
---|
1612 | 1612 | | 1592in section 9 of chapter 6D and the affordability benchmark established in section 9A of said |
---|
1613 | 1613 | | 1593chapter 6D. |
---|
1614 | 1614 | | 1594 (d) The deputy commissioner shall review data and documents submitted to the division, |
---|
1615 | 1615 | | 1595including, but not limited to, any materials submitted as part of rate reviews, to examine the |
---|
1616 | 1616 | | 1596causes of premium rate increases and excessive provider price variation. 75 of 119 |
---|
1617 | 1617 | | 1597 (e) The commissioner shall appoint, at a minimum, the following employees to the |
---|
1618 | 1618 | | 1598bureau: a deputy commissioner, a general counsel, a chief health economist, a chief actuary, a |
---|
1619 | 1619 | | 1599chief research analyst and a chief examiner. The appointed employees shall devote their full time |
---|
1620 | 1620 | | 1600to the duties of their offices, shall be exempt from chapters 30 and 31 and shall serve at the |
---|
1621 | 1621 | | 1601pleasure of the commissioner. The commissioner may appoint and remove additional employees, |
---|
1622 | 1622 | | 1602including, but not limited to, a first deputy, economists, analysts, examiners, assistant actuaries, |
---|
1623 | 1623 | | 1603inspectors, clerks and other assistants as the work of the division may require. Such additional |
---|
1624 | 1624 | | 1604employees shall perform such duties as the commissioner may prescribe. |
---|
1625 | 1625 | | 1605 (f) The commissioner shall make and collect an assessment against the carriers licensed |
---|
1626 | 1626 | | 1606under chapters 175, 176A, 176B, 176E, 176F and 176G to pay for the expenses of the bureau. |
---|
1627 | 1627 | | 1607The assessment shall be at a rate sufficient to produce $1,000,000 annually. In addition to that |
---|
1628 | 1628 | | 1608amount, the assessment shall include an amount to be credited to the General Fund which shall |
---|
1629 | 1629 | | 1609be equal to the total amount of funds estimated by the secretary of administration and finance to |
---|
1630 | 1630 | | 1610be expended from the General Fund for indirect and fringe benefit costs attributable to the |
---|
1631 | 1631 | | 1611personnel costs of the bureau. The assessment shall be allocated on a fair and reasonable basis |
---|
1632 | 1632 | | 1612among all carriers licensed under said chapters. The funds produced by the assessments shall be |
---|
1633 | 1633 | | 1613expended by the bureau, in addition to any other funds which may be appropriated, to assist in |
---|
1634 | 1634 | | 1614defraying the general operating expenses of the division and may be used to compensate |
---|
1635 | 1635 | | 1615consultants retained by the bureau. A carrier licensed under said chapters shall pay the amount |
---|
1636 | 1636 | | 1616assessed against it within 30 days after the date of the notice of assessment from the |
---|
1637 | 1637 | | 1617commissioner. |
---|
1638 | 1638 | | 1618 (g) Notwithstanding any general or special law to the contrary, carriers offering health |
---|
1639 | 1639 | | 1619benefit plans, including carriers licensed under chapter 175, 176A, 176B or 176G, shall annually 76 of 119 |
---|
1640 | 1640 | | 1620file a summary of negotiated rate increases for their largest providers, by provider group to the |
---|
1641 | 1641 | | 1621bureau. The deputy commissioner shall confidentially provide such information to the health |
---|
1642 | 1642 | | 1622policy commission. |
---|
1643 | 1643 | | 1623 Rates of reimbursement or rate increases submitted for review by the bureau under this |
---|
1644 | 1644 | | 1624section shall be deemed confidential and exempt from the definition of public records in clause |
---|
1645 | 1645 | | 1625Twenty-sixth of section 7 of chapter 4 or section 10 of chapter 66. The deputy commissioner |
---|
1646 | 1646 | | 1626shall adopt regulations to carry out this section. |
---|
1647 | 1647 | | 1627 SECTION 81. Subsection (b) of section 7H½ of chapter 29 of the General Laws, as so |
---|
1648 | 1648 | | 1628appearing, is hereby amended by striking out the first sentence and inserting in place thereof the |
---|
1649 | 1649 | | 1629following sentence:- Annually, not later than January 15, the secretary of administration and |
---|
1650 | 1650 | | 1630finance shall meet with the house and senate committees on ways and means and shall jointly |
---|
1651 | 1651 | | 1631develop a growth rate of potential gross state product for the calendar year that will begin 2 years |
---|
1652 | 1652 | | 1632following the calendar year in which the January 15 date occurs, which shall be agreed to by the |
---|
1653 | 1653 | | 1633secretary and the committees. |
---|
1654 | 1654 | | 1634 SECTION 82. Section 9-609 of chapter 106 of the General Laws, as so appearing, is |
---|
1655 | 1655 | | 1635hereby amended by adding the following subsection:- |
---|
1656 | 1656 | | 1636 (d) Notwithstanding subsection (a), in the case of a debtor that is a hospital licensed by |
---|
1657 | 1657 | | 1637the department of public health under section 51 of chapter 111 and collateral that is a medical |
---|
1658 | 1658 | | 1638device, a secured party shall send notice to the debtor and the department of public health not |
---|
1659 | 1659 | | 1639less than 90 days prior to taking possession of the collateral, rendering equipment unusable or |
---|
1660 | 1660 | | 1640disposing of the collateral on the debtor’s premises pursuant to subsection (a). For the purposes 77 of 119 |
---|
1661 | 1661 | | 1641of this subsection, “medical device” shall have the same meaning as that term is defined in |
---|
1662 | 1662 | | 1642section 1 of chapter 111N. |
---|
1663 | 1663 | | 1643 SECTION 83. Section 1 of chapter 111 of the General Laws, as so appearing, is hereby |
---|
1664 | 1664 | | 1644amended by inserting after the definition “Nuclear reactor” the following definition:- |
---|
1665 | 1665 | | 1645 “Party of record”, during the pendency of an application for a determination of need, an |
---|
1666 | 1666 | | 1646applicant for a determination of need, the attorney general, the center for health information and |
---|
1667 | 1667 | | 1647analysis, the health policy commission, any government agency with relevant oversight or |
---|
1668 | 1668 | | 1648licensure authority over the proposed project or components therein or any 10 taxpayers of the |
---|
1669 | 1669 | | 1649commonwealth organized as a group. |
---|
1670 | 1670 | | 1650 SECTION 84. Section 25A of said chapter 111, as so appearing, is hereby amended by |
---|
1671 | 1671 | | 1651striking out the first 5 paragraphs. |
---|
1672 | 1672 | | 1652 SECTION 85. Section 25C of said chapter 111, as so appearing, is hereby amended by |
---|
1673 | 1673 | | 1653striking out subsections (g) to (j), inclusive, and inserting in place thereof the following 4 |
---|
1674 | 1674 | | 1654subsections:- |
---|
1675 | 1675 | | 1655 (g) The department, in making any determination of need, shall: (i) assess both the |
---|
1676 | 1676 | | 1656applicant and the proposed project; (ii) be guided by the state health plan and focused health |
---|
1677 | 1677 | | 1657assessments pursuant to section 22 of chapter 6D and the health care resources inventory |
---|
1678 | 1678 | | 1658pursuant to section 9 of chapter 12C; (iii) encourage appropriate allocation of private and public |
---|
1679 | 1679 | | 1659health care resources and the development of alternative or substitute methods of delivering |
---|
1680 | 1680 | | 1660health care services so that adequate health care services will be made reasonably available to |
---|
1681 | 1681 | | 1661every person within the commonwealth at the lowest reasonable aggregate cost; (iv) be guided |
---|
1682 | 1682 | | 1662by the commonwealth’s cost containment and affordability goals; (v) assess the impacts on the 78 of 119 |
---|
1683 | 1683 | | 1663applicant’s patients and on other residents of the commonwealth, including, but not limited to, |
---|
1684 | 1684 | | 1664considerations of health equity and the workforce of surrounding health care providers; and (vi) |
---|
1685 | 1685 | | 1665take into account any comments and relevant data from the center for health information and |
---|
1686 | 1686 | | 1666analysis, the health policy commission, including, but not limited to, any cost and market impact |
---|
1687 | 1687 | | 1667review report pursuant to subsection (f) of section 13 of chapter 6D, and any other state agency |
---|
1688 | 1688 | | 1668or entity. The department may impose reasonable terms and conditions on the approval of a |
---|
1689 | 1689 | | 1669determination of need as the department determines are necessary to achieve the purposes and |
---|
1690 | 1690 | | 1670intent of this section, including, but not limited to, conditions intended to address health care |
---|
1691 | 1691 | | 1671disparities and better align a project with community needs. The department may recognize the |
---|
1692 | 1692 | | 1672special needs and circumstances of projects that: (i) are essential to the conduct of research in |
---|
1693 | 1693 | | 1673basic biomedical or health care delivery areas or to the training of health care personnel; (ii) are |
---|
1694 | 1694 | | 1674unlikely to result in any increase in the clinical bed capacity or outpatient load capacity of the |
---|
1695 | 1695 | | 1675facility; and (iii) are unlikely to cause an increase in the total patient care charges of the facility |
---|
1696 | 1696 | | 1676to the public for health care services, supplies and accommodations, as such charges shall be |
---|
1697 | 1697 | | 1677defined from time to time in accordance with section 5 of chapter 409 of the acts of 1976. The |
---|
1698 | 1698 | | 1678department may also recognize the special needs and circumstances of projects that may address |
---|
1699 | 1699 | | 1679a lack of supply for a specific region, population or service line that has been identified in the |
---|
1700 | 1700 | | 1680state health plan or focused assessments pursuant to section 22 of chapter 6D. |
---|
1701 | 1701 | | 1681 (h) Applications for such determination shall be filed with the department, together with |
---|
1702 | 1702 | | 1682other forms and information as shall be prescribed by, or acceptable to, the department. No |
---|
1703 | 1703 | | 1683provider or provider organization may apply for a notice of determination of need until a |
---|
1704 | 1704 | | 1684material change notice, if required, has been submitted to the health policy commission under |
---|
1705 | 1705 | | 1685section 13 of chapter 6D. A duplicate copy of any application together with supporting 79 of 119 |
---|
1706 | 1706 | | 1686documentation for such application, shall be a public record and kept on file in the department. |
---|
1707 | 1707 | | 1687The department may require a public hearing on any application at its discretion or at the request |
---|
1708 | 1708 | | 1688of the attorney general. The attorney general may intervene in any hearing under this section. A |
---|
1709 | 1709 | | 1689reasonable fee, established by the department, shall be paid upon the filing of such application; |
---|
1710 | 1710 | | 1690provided, however, that such fee shall not exceed 0.2 per cent of the capital expenditures, if any, |
---|
1711 | 1711 | | 1691proposed by the applicant. The department may adapt the information required and fees required |
---|
1712 | 1712 | | 1692for applications if it determines a project or class of projects may address a lack of supply for a |
---|
1713 | 1713 | | 1693specific region, population or service line that has been identified in the state health plan or |
---|
1714 | 1714 | | 1694focused assessments pursuant to section 22 of chapter 6D. The department may also require an |
---|
1715 | 1715 | | 1695independent cost analysis be conducted, at the expense of the applicant, by an entity selected and |
---|
1716 | 1716 | | 1696overseen by the department, including, but not limited to, another state agency, to demonstrate |
---|
1717 | 1717 | | 1697that the application is consistent with the commonwealth's efforts to meet the health care cost |
---|
1718 | 1718 | | 1698containment goals established by the commission. Such entity may request, and the applicant |
---|
1719 | 1719 | | 1699may not unreasonably withhold, confidential data and documents necessary to conduct an |
---|
1720 | 1720 | | 1700independent cost analysis pursuant to such section; provided, however, that any confidential data |
---|
1721 | 1721 | | 1701and documents so requested shall be provided to the entity conducting the independent cost |
---|
1722 | 1722 | | 1702analysis, the department, the health policy commission and the attorney general, but shall not be |
---|
1723 | 1723 | | 1703disclosed to any other person without the consent of the applicant, except in summary form, or |
---|
1724 | 1724 | | 1704when the department, health policy commission or attorney general determines that such |
---|
1725 | 1725 | | 1705disclosure should be made in the public interest after taking into account any privacy, trade |
---|
1726 | 1726 | | 1706secret or anticompetitive considerations; and provided further, that any confidential data and |
---|
1727 | 1727 | | 1707documents so provided shall not be public records and shall be exempt from disclosure under |
---|
1728 | 1728 | | 1708clause Twenty-sixth of section 7 of chapter 4 or section 10 of chapter 66. 80 of 119 |
---|
1729 | 1729 | | 1709 (i) Except in the case of an emergency situation determined by the department as |
---|
1730 | 1730 | | 1710requiring immediate action to prevent further damage to the public health or to a health care |
---|
1731 | 1731 | | 1711facility, the department shall not act upon an application for such determination unless: (i) the |
---|
1732 | 1732 | | 1712application has been on file with the department for not less than 30 days; (ii) the center for |
---|
1733 | 1733 | | 1713health information and analysis, the health policy commission, the office of the attorney general, |
---|
1734 | 1734 | | 1714the state and appropriate regional comprehensive health planning agencies and, in the case of |
---|
1735 | 1735 | | 1715long-term care facilities only, the department of elder affairs, or in the case of any facility |
---|
1736 | 1736 | | 1716providing inpatient services for individuals with intellectual or developmentally disabilities, the |
---|
1737 | 1737 | | 1717departments of mental health or developmental services, respectively, have been provided copies |
---|
1738 | 1738 | | 1718of such application and supporting documents and given reasonable opportunity to supply |
---|
1739 | 1739 | | 1719required information and comment on such application; and (iii) a public hearing has been held |
---|
1740 | 1740 | | 1720on such application when requested by the applicant, the state or appropriate regional |
---|
1741 | 1741 | | 1721comprehensive health planning agency, any 10 taxpayers of the commonwealth or any other |
---|
1742 | 1742 | | 1722party of record. If, in any filing period, an individual application is filed that would implicitly |
---|
1743 | 1743 | | 1723decide any other application filed during such period, the department shall not act only upon an |
---|
1744 | 1744 | | 1724individual application. |
---|
1745 | 1745 | | 1725 (j) The department shall so approve or disapprove, in whole or in part, each such |
---|
1746 | 1746 | | 1726application for a determination of need not more than 6 months after filing with the department; |
---|
1747 | 1747 | | 1727provided, however, that the department may, on not more than 1 occasion, delay the action for up |
---|
1748 | 1748 | | 1728to 2 months after the applicant has provided information which the department has reasonably |
---|
1749 | 1749 | | 1729requested during the 8-month period; provided further, that: (i) the period for review of an |
---|
1750 | 1750 | | 1730application for which an independent cost analysis is conducted pursuant to subsection (h) shall |
---|
1751 | 1751 | | 1731be stayed until a completed independent cost analysis is received and accepted by the 81 of 119 |
---|
1752 | 1752 | | 1732department: (ii) the period of review of an application for which the commission conducts a cost |
---|
1753 | 1753 | | 1733and market impact review shall be stayed until a final cost and market impact review has been |
---|
1754 | 1754 | | 1734issued: and (iii) the period of review of an application for which the applicant is subject to a |
---|
1755 | 1755 | | 1735performance improvement plan pursuant to section 10 of chapter 6D shall be stayed until the |
---|
1756 | 1756 | | 1736commission determines that the applicant is implementing or has implemented said performance |
---|
1757 | 1757 | | 1737improvement plan in good faith; and provided further, that the commission may rescind its |
---|
1758 | 1758 | | 1738determination that the applicant is implementing a performance improvement plan in good faith |
---|
1759 | 1759 | | 1739at any time prior to successful completion of the performance improvement plan. Applications |
---|
1760 | 1760 | | 1740remanded to the department by the health facilities appeals board under section 25E shall be |
---|
1761 | 1761 | | 1741acted upon by the department within the same time limits provided in this section for the |
---|
1762 | 1762 | | 1742department to approve or disapprove applications for a determination of need. If an application |
---|
1763 | 1763 | | 1743has not been acted upon by the department within such time limits, the applicant may, within a |
---|
1764 | 1764 | | 1744reasonable period of time, bring an action in the nature of mandamus in the superior court to |
---|
1765 | 1765 | | 1745require the department to act upon the application. |
---|
1766 | 1766 | | 1746 SECTION 86. Said section 25C of said chapter 111, as so appearing, is hereby further |
---|
1767 | 1767 | | 1747amended by adding the following 2 subsections:- |
---|
1768 | 1768 | | 1748 (o) Notwithstanding sections (a) through (d), the department may create a process under |
---|
1769 | 1769 | | 1749which persons or entities proposing a project that would normally require a determination of |
---|
1770 | 1770 | | 1750need may apply for a waiver of such requirement. Such waiver shall be granted only in cases in |
---|
1771 | 1771 | | 1751which the person or entity demonstrates the project will address a lack of supply for a specific |
---|
1772 | 1772 | | 1752region, population or service line that has been identified in the state health plan or focused |
---|
1773 | 1773 | | 1753assessments pursuant to section 22 of chapter 6D. The department may require a waiver request |
---|
1774 | 1774 | | 1754be accompanied by forms and information as shall be prescribed by, or acceptable to, the 82 of 119 |
---|
1775 | 1775 | | 1755department. A duplicate copy of any waiver request together with supporting documentation for |
---|
1776 | 1776 | | 1756such application shall be a public record and kept on file in the department. |
---|
1777 | 1777 | | 1757 (p) A party of record may review an application for determination of need and provide |
---|
1778 | 1778 | | 1758written comment or specific recommendations for consideration by the department. Whenever a |
---|
1779 | 1779 | | 1759party of record submits written materials concerning an application for determination of need, |
---|
1780 | 1780 | | 1760the department shall provide copies of such materials to all other parties of record. |
---|
1781 | 1781 | | 1761 SECTION 87. Section 25F of said chapter 111, as so appearing, is hereby amended by |
---|
1782 | 1782 | | 1762inserting after the word “care”, in line 7, the following word:- financing. |
---|
1783 | 1783 | | 1763 SECTION 88. Paragraph (4) of subsection (d) of section 51G of said chapter 111, as so |
---|
1784 | 1784 | | 1764appearing, is hereby further amended by inserting, after the third sentence, the following |
---|
1785 | 1785 | | 1765sentence:- |
---|
1786 | 1786 | | 1766 The department may seek an analysis of the impact of the closure from the health policy |
---|
1787 | 1787 | | 1767commission. |
---|
1788 | 1788 | | 1768 SECTION 89. Said subsection (d) of said section 51G of said chapter 111, as so |
---|
1789 | 1789 | | 1769appearing, is hereby further amended by adding the following 2 paragraphs:- |
---|
1790 | 1790 | | 1770 (7) No original license shall be granted or renewed, to establish or maintain an acute-care |
---|
1791 | 1791 | | 1771hospital unless: (i) all documents related to any lease, master lease, sublease, license or any other |
---|
1792 | 1792 | | 1772agreement for the use, occupancy or utilization of the premises occupied by the acute-care |
---|
1793 | 1793 | | 1773hospital are disclosed to the department upon application for licensure; and (ii) the department |
---|
1794 | 1794 | | 1774has reviewed such documentation and determined the applicant is suitable for licensure. 83 of 119 |
---|
1795 | 1795 | | 1775 (8) No original license shall be granted, nor renewed, to establish or maintain an acute- |
---|
1796 | 1796 | | 1776care hospital, as defined in section 25B, unless the applicant is in compliance with the reporting |
---|
1797 | 1797 | | 1777requirements established in sections 8 to 10, inclusive, of chapter 12C. |
---|
1798 | 1798 | | 1778 SECTION 90. Section 51H of said chapter 111, as so appearing, is hereby amended by |
---|
1799 | 1799 | | 1779striking out the definition of “Facility” and inserting in place thereof the following definition: |
---|
1800 | 1800 | | 1780 “Facility”, a hospital, institution for the care of unwed mothers, clinic providing |
---|
1801 | 1801 | | 1781ambulatory surgery as defined in section 25B, limited-service clinic licensed pursuant to section |
---|
1802 | 1802 | | 178251J, office-based surgical center licensed pursuant to section 51M or urgent care center licensed |
---|
1803 | 1803 | | 1783pursuant to section 51N. |
---|
1804 | 1804 | | 1784 SECTION 91. Said section 51H of said chapter 111, as so appearing, is hereby further |
---|
1805 | 1805 | | 1785amended by inserting after the definition of “Healthcare-associated infection” the following |
---|
1806 | 1806 | | 1786definition:- |
---|
1807 | 1807 | | 1787 “Operational impairment event”, any action, or notice of impending action, including a |
---|
1808 | 1808 | | 1788notice of financial delinquency, concerning the repossession of medical equipment or supplies |
---|
1809 | 1809 | | 1789necessary for the provision of patient care. |
---|
1810 | 1810 | | 1790 SECTION 92. Subsection (b) of said section 51H of said chapter 111, as so appearing, is |
---|
1811 | 1811 | | 1791hereby amended by adding the following paragraph:- |
---|
1812 | 1812 | | 1792 An operational impairment event shall be reported by a facility to the department not later |
---|
1813 | 1813 | | 1793than 1 calendar day after it occurs. Notwithstanding any general or special law to the contrary, no |
---|
1814 | 1814 | | 1794contract between a facility and a lessor of medical equipment shall authorize the repossession of |
---|
1815 | 1815 | | 1795medical equipment or supplies unless the lessor provides a notice of financial delinquency to the 84 of 119 |
---|
1816 | 1816 | | 1796department not less than 90 days prior to repossession of any medical equipment or supplies |
---|
1817 | 1817 | | 1797necessary for the provision of patient care. Any provision of any contract or other document |
---|
1818 | 1818 | | 1798between a lessor of medical equipment and a facility which does not comply with this paragraph |
---|
1819 | 1819 | | 1799shall be void. |
---|
1820 | 1820 | | 1800 SECTION 93. Said chapter 111 is hereby further amended by inserting after section 51L |
---|
1821 | 1821 | | 1801the following 2 sections:- |
---|
1822 | 1822 | | 1802 Section 51M. (a) As used in this section, the following words shall, unless the context |
---|
1823 | 1823 | | 1803clearly requires otherwise, have the following meanings:- |
---|
1824 | 1824 | | 1804 “Deep sedation”, a drug-induced depression of consciousness during which: (i) the |
---|
1825 | 1825 | | 1805patient cannot be easily awakened but responds purposefully following repeated painful |
---|
1826 | 1826 | | 1806stimulation; (ii) the patient’s ability to maintain independent ventilatory function may be |
---|
1827 | 1827 | | 1807impaired; (iii) the patient may require assistance in maintaining a patent airway and spontaneous |
---|
1828 | 1828 | | 1808ventilation may be inadequate; and (iv) the patient’s cardiovascular function is usually |
---|
1829 | 1829 | | 1809maintained without assistance. |
---|
1830 | 1830 | | 1810 “General anesthesia”, a drug-induced depression of consciousness during which: (i) the |
---|
1831 | 1831 | | 1811patient is not able to be awakened, even by painful stimulation; (ii) the patient’s ability to |
---|
1832 | 1832 | | 1812maintain independent ventilatory function is often impaired; (iii) the patient, in many cases, often |
---|
1833 | 1833 | | 1813requires assistance in maintaining a patent airway and positive pressure ventilation may be |
---|
1834 | 1834 | | 1814required because of depressed spontaneous ventilation or drug-induced depression of |
---|
1835 | 1835 | | 1815neuromuscular function; and (iv) the patient’s cardiovascular function may be impaired. 85 of 119 |
---|
1836 | 1836 | | 1816 “Minimal sedation”, a drug-induced state during which: (i) patients respond normally to |
---|
1837 | 1837 | | 1817verbal commands; (ii) cognitive function and coordination may be impaired; and (iii) ventilatory |
---|
1838 | 1838 | | 1818and cardiovascular functions are unaffected. |
---|
1839 | 1839 | | 1819 “Minor procedures”, (i) procedures that can be performed safely with a minimum of |
---|
1840 | 1840 | | 1820discomfort where the likelihood of complications requiring hospitalization is minimal; (ii) |
---|
1841 | 1841 | | 1821procedures performed with local or topical anesthesia; or (iii) liposuction with removal of less |
---|
1842 | 1842 | | 1822than 500cc of fat under un-supplemented local anesthesia. |
---|
1843 | 1843 | | 1823 “Moderate sedation”, a drug-induced depression of consciousness during which: (i) the |
---|
1844 | 1844 | | 1824patient responds purposefully to verbal commands, either alone or accompanied by light tactile |
---|
1845 | 1845 | | 1825stimulation; (ii) no interventions are required to maintain a patent airway; (iii) spontaneous |
---|
1846 | 1846 | | 1826ventilation is adequate; and (iv) the patient’s cardiovascular function is usually maintained |
---|
1847 | 1847 | | 1827without assistance. |
---|
1848 | 1848 | | 1828 “Office-based surgical center”, an office, group of offices, a facility or any portion |
---|
1849 | 1849 | | 1829thereof owned, leased or operated by 1 or more practitioners engaged in a solo or group practice, |
---|
1850 | 1850 | | 1830however organized, whether conducted for profit or not for profit, which is advertised, |
---|
1851 | 1851 | | 1831announced, established or maintained for the purpose of providing office-based surgical services; |
---|
1852 | 1852 | | 1832provided, however, that “office-based surgical center” shall not include: (i) a hospital licensed |
---|
1853 | 1853 | | 1833under section 51 or by the federal government; (ii) an ambulatory surgical center as defined |
---|
1854 | 1854 | | 1834pursuant to section 25B and licensed under said section 51; or (iii) a surgical center performing |
---|
1855 | 1855 | | 1835services in accordance with section 12M of chapter 112. |
---|
1856 | 1856 | | 1836 “Office-based surgical services”, an ambulatory surgical or other invasive procedure |
---|
1857 | 1857 | | 1837requiring: (i) general anesthesia; (ii) moderate sedation; or (iii) deep sedation and any liposuction 86 of 119 |
---|
1858 | 1858 | | 1838procedure, excluding minor procedures and procedures requiring minimal sedation, where such |
---|
1859 | 1859 | | 1839surgical or other invasive procedure or liposuction is performed by a practitioner at an office- |
---|
1860 | 1860 | | 1840based surgical center. |
---|
1861 | 1861 | | 1841 (b) The department shall establish rules, regulations and practice standards for the |
---|
1862 | 1862 | | 1842licensing of office-based surgical centers. In determining rules, regulations and practice |
---|
1863 | 1863 | | 1843standards necessary for licensure as an office-based surgical center, the department may, at its |
---|
1864 | 1864 | | 1844discretion, determine which regulations applicable to an ambulatory surgical center, as defined in |
---|
1865 | 1865 | | 1845section 25B, shall apply to an office-based surgical center. The department shall consult with the |
---|
1866 | 1866 | | 1846board of registration in medicine prior to promulgating regulations or establishing rules or |
---|
1867 | 1867 | | 1847practice standards pursuant to this section. |
---|
1868 | 1868 | | 1848 (c) The department shall issue for a term of 2 years and renew for a like term, a license to |
---|
1869 | 1869 | | 1849maintain an office-based surgical center to an entity or organization that demonstrates to the |
---|
1870 | 1870 | | 1850department that it is responsible and suitable to maintain such a center. An office-based surgical |
---|
1871 | 1871 | | 1851center license shall list the specific locations on the premises where surgical services are |
---|
1872 | 1872 | | 1852provided. In the case of the transfer of ownership of an office-based surgical center, the |
---|
1873 | 1873 | | 1853application of the new owner for a license, when filed with the department on the date of transfer |
---|
1874 | 1874 | | 1854of ownership, shall have the effect of a license for a period of 3 months. |
---|
1875 | 1875 | | 1855 (d) An office-based surgical center license shall be subject to suspension, revocation or |
---|
1876 | 1876 | | 1856refusal to issue or to renew for cause if, in its reasonable discretion, the department determines |
---|
1877 | 1877 | | 1857that the issuance of such license would be inconsistent with the best interests of the public health, |
---|
1878 | 1878 | | 1858welfare or safety. Nothing in this subsection shall limit the authority of the department to require 87 of 119 |
---|
1879 | 1879 | | 1859a fee, impose a fine, conduct surveys and investigations or to suspend, revoke or refuse to renew |
---|
1880 | 1880 | | 1860a license issued pursuant to subsection (c). |
---|
1881 | 1881 | | 1861 (e) Initial application and renewal fees for the license shall be established pursuant to |
---|
1882 | 1882 | | 1862section 3B of chapter 7. |
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1883 | 1883 | | 1863 (f) The department may impose a fine of up to $10,000 on a person or entity that |
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1884 | 1884 | | 1864advertises, announces, establishes or maintains an office-based surgical center without a license |
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1885 | 1885 | | 1865granted by the department. The department may impose a fine of not more than $10,000 on a |
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1886 | 1886 | | 1866licensed office-based surgical center for violations of this section or any rule or regulation |
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1887 | 1887 | | 1867promulgated pursuant to this section. Each day during which a violation continues shall |
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1888 | 1888 | | 1868constitute a separate offense. The department may conduct surveys and investigations to enforce |
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1889 | 1889 | | 1869compliance with this section. |
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1890 | 1890 | | 1870 (g) Notwithstanding any general or special law or rule to the contrary, the department |
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1891 | 1891 | | 1871may issue a 1-time provisional license to an applicant for an office-based surgical center licensed |
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1892 | 1892 | | 1872pursuant to this section if such office-based surgical center holds: (i) a current accreditation from |
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1893 | 1893 | | 1873the Accreditation Association for Ambulatory Health Care, American Association for |
---|
1894 | 1894 | | 1874Accreditation of Ambulatory Surgery Facilities, Inc., or the Joint Commission On Accreditation |
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1895 | 1895 | | 1875of Healthcare Organizations; or (ii) a current certification for participation in either Medicare or |
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1896 | 1896 | | 1876Medicaid. The department may approve such a provisional application upon a finding of |
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1897 | 1897 | | 1877responsibility and suitability and that the office-based surgical center meets all other licensure |
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1898 | 1898 | | 1878requirements as determined by the department. Such provisional license issued to an office-based |
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1899 | 1899 | | 1879surgical center shall not be extended or renewed. 88 of 119 |
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1900 | 1900 | | 1880 Section 51N. (a) As used in this section, the following words shall have the following |
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1901 | 1901 | | 1881meanings unless the context clearly requires otherwise:- |
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1902 | 1902 | | 1882 “Emergency services”, as defined in section 1 of chapter 6D. |
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1903 | 1903 | | 1883 “Urgent care center”, a clinic owned or operated by an entity that is not corporately |
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1904 | 1904 | | 1884affiliated with a hospital licensed under section 51, however organized, whether conducted for |
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1905 | 1905 | | 1885profit or not for profit, that is advertised, announced, established or maintained for the purpose of |
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1906 | 1906 | | 1886providing urgent care services in an office or a group of offices, or any portion thereof, or an |
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1907 | 1907 | | 1887entity that is advertised, announced, established or maintained under a name that includes the |
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1908 | 1908 | | 1888words “urgent care” or that suggests that urgent care services are provided therein and is not |
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1909 | 1909 | | 1889corporately affiliated with a hospital licensed under 51; provided, however, that an urgent care |
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1910 | 1910 | | 1890center shall not include: (i) a hospital licensed under said section 51 or operated by the federal |
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1911 | 1911 | | 1891government or by the commonwealth; (ii) a clinic licensed under said section 51; (iii) a limited |
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1912 | 1912 | | 1892service clinic licensed under section 51J; or (iv) a community health center receiving a grant |
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1913 | 1913 | | 1893under 42 U.S.C. 254b. |
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1914 | 1914 | | 1894 “Urgent care services”, a model of episodic care for the diagnosis, treatment, |
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1915 | 1915 | | 1895management or monitoring of acute and chronic disease or injury that is: (i) for the treatment of |
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1916 | 1916 | | 1896illness or injury that is immediate in nature but does not require emergency services; (ii) |
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1917 | 1917 | | 1897provided on a walk-in basis without a prior appointment; (iii) available to the general public |
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1918 | 1918 | | 1898during times of the day, weekends or holidays when primary care provider offices are not |
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1919 | 1919 | | 1899customarily open; and (iv) not intended, and should not be used for, preventative or routine |
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1920 | 1920 | | 1900services. 89 of 119 |
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1921 | 1921 | | 1901 (b) The department shall establish rules, regulations and practice standards for the |
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1922 | 1922 | | 1902licensing of urgent care centers. In determining regulations and practice standards necessary for |
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1923 | 1923 | | 1903licensure as an urgent care center, the department may, at its discretion, determine which |
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1924 | 1924 | | 1904regulations applicable to a clinic licensed under section 51, shall apply to an urgent care center. |
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1925 | 1925 | | 1905 (c) The department shall issue for a term of 2 years and renew for a like term, a license to |
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1926 | 1926 | | 1906maintain an urgent care center to an entity or organization that demonstrates to the department |
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1927 | 1927 | | 1907that it is responsible and suitable to maintain such an urgent care center. In the case of the |
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1928 | 1928 | | 1908transfer of ownership of an urgent care center, the application of the new owner for a license, |
---|
1929 | 1929 | | 1909when filed with the department on the date of transfer of ownership, shall have the effect of a |
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1930 | 1930 | | 1910license for a period of 3 months. |
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1931 | 1931 | | 1911 (d) An urgent care center license shall be subject to suspension, revocation or refusal to |
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1932 | 1932 | | 1912issue or to renew for cause if, in its reasonable discretion, the department determines that the |
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1933 | 1933 | | 1913issuance of such license would be inconsistent with or opposed to the best interests of the public |
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1934 | 1934 | | 1914health, welfare or safety. Nothing in this subsection shall limit the authority of the department to |
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1935 | 1935 | | 1915require a fee, impose a fine, conduct surveys and investigations or to suspend, revoke or refuse to |
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1936 | 1936 | | 1916renew a license issued pursuant to subsection (c). |
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1937 | 1937 | | 1917 (e) Initial application and renewal fees for the license shall be established pursuant to |
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1938 | 1938 | | 1918section 3B of chapter 7. |
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1939 | 1939 | | 1919 (f) The department may impose a fine of up to $10,000 on a person or entity that |
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1940 | 1940 | | 1920advertises, announces, establishes or maintains an urgent care center without a license granted by |
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1941 | 1941 | | 1921the department. The department may impose a fine of not more than $10,000 on a licensed |
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1942 | 1942 | | 1922urgent care center for violations of this section or any rule or regulation promulgated pursuant to 90 of 119 |
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1943 | 1943 | | 1923this section. Each day during which a violation continues shall constitute a separate offense. The |
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1944 | 1944 | | 1924department may conduct surveys and investigations to enforce compliance with this section. |
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1945 | 1945 | | 1925 (g) Notwithstanding any general or special law or rule to the contrary, the department |
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1946 | 1946 | | 1926may issue a 1-time provisional license to an applicant for an urgent care center if such urgent |
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1947 | 1947 | | 1927care center holds: (i) a current accreditation from the Accreditation Association for Ambulatory |
---|
1948 | 1948 | | 1928Health Care, Urgent Care Association of America or the Joint Commission On Accreditation of |
---|
1949 | 1949 | | 1929Healthcare Organizations; or (ii) a current certification for participation in either Medicare or |
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1950 | 1950 | | 1930Medicaid. The department may approve such provisional application upon a finding of |
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1951 | 1951 | | 1931responsibility and suitability and that the urgent care center meets all other licensure |
---|
1952 | 1952 | | 1932requirements as determined by the department. Such provisional license issued to an urgent care |
---|
1953 | 1953 | | 1933center shall not be extended or renewed. |
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1954 | 1954 | | 1934 SECTION 94. Said section 218 of said chapter 111, as so appearing, is hereby further |
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1955 | 1955 | | 1935amended by striking out, in line 28, the words “Maintenance Organizations” and inserting in |
---|
1956 | 1956 | | 1936place thereof the following word:- Plans. |
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1957 | 1957 | | 1937 SECTION 95. Said chapter 111, as so appearing, is hereby further amended by inserting |
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1958 | 1958 | | 1938after section 244 the following section:- |
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1959 | 1959 | | 1939 Section 245. (a) Pursuant to section 23 of chapter 6D, a private equity firm shall deposit, |
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1960 | 1960 | | 1940upon submission of a notice of material change pursuant to section 13 of chapter 6D, a bond with |
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1961 | 1961 | | 1941the department of public health. |
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1962 | 1962 | | 1942 (b) Until such bond has been deposited, the department of public health shall not issue a |
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1963 | 1963 | | 1943license to such provider or provider organization under this chapter, the department of mental |
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1964 | 1964 | | 1944health shall not issue a license to such provider or provider organization under chapter 19, and 91 of 119 |
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1965 | 1965 | | 1945any determination of need application submitted under sections 25B to 25G, inclusive, of said |
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1966 | 1966 | | 1946chapter 111 or material change notice submitted under section 13 of chapter 6D shall be deemed |
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1967 | 1967 | | 1947incomplete. Notwithstanding any general or special law to the contrary, if the bond has not been |
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1968 | 1968 | | 1948deposited, but the department of public health would otherwise be eligible to collect the bond, |
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1969 | 1969 | | 1949the department shall be permitted to collect from the private equity firm the amount it would |
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1970 | 1970 | | 1950have been able to collect had the bond been deposited. |
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1971 | 1971 | | 1951 (c) The health policy commission shall determine the amount of the bond, which shall |
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1972 | 1972 | | 1952equal 1 year of the provider or provider organization’s average or estimated operating expenses, |
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1973 | 1973 | | 1953plus the estimated cost of hiring an independent supervisor and reasonable staff to supervise and |
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1974 | 1974 | | 1954facilitate collecting and spending the bond. The private equity firm shall maintain the bond for as |
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1975 | 1975 | | 1955long as it has a financial interest in the provider or provider organization, and for 7 years |
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1976 | 1976 | | 1956thereafter. |
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1977 | 1977 | | 1957 (d) The department of public health may collect the bond if the health policy commission |
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1978 | 1978 | | 1958provides the department of public health with notification pursuant to subsection (c) of section |
---|
1979 | 1979 | | 195923 of chapter 6D, or if the provider or provider organization in which the private equity firm has |
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1980 | 1980 | | 1960or had a financial interest declares bankruptcy. The department of public health, in consultation |
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1981 | 1981 | | 1961with the health policy commission and the center for health information and analysis, shall use |
---|
1982 | 1982 | | 1962the bond proceeds to support the continued provision of health services to patients served by the |
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1983 | 1983 | | 1963provider or provider organization. Prior to spending the bond, the department of public health |
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1984 | 1984 | | 1964shall seek input from the public, including, but not limited to, providers, provider organizations |
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1985 | 1985 | | 1965and patients in the affected region, regarding how to spend the bond. The department of public |
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1986 | 1986 | | 1966health may, in consultation with the health policy commission and center for health information 92 of 119 |
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1987 | 1987 | | 1967and analysis, select an independent supervisor and reasonable staff to supervise and facilitate |
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1988 | 1988 | | 1968collecting and spending the bond. |
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1989 | 1989 | | 1969 SECTION 96. Section 1 of chapter 112 of the General Laws, as so appearing, is hereby |
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1990 | 1990 | | 1970amended by inserting after the third paragraph the following paragraph:- |
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1991 | 1991 | | 1971 The commissioner of occupational licensure and the commissioner of public health shall |
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1992 | 1992 | | 1972by regulation define the words “good moral character”, establish a standardized assessment of |
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1993 | 1993 | | 1973“good moral character” for applicants for certification or licensure. Each of the boards of |
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1994 | 1994 | | 1974registration and examination under supervision of the commissioner of occupational licensure |
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1995 | 1995 | | 1975and the commissioner of public health shall apply said standard definition and assessment of |
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1996 | 1996 | | 1976“good moral character” for applicants of certification or licensure. The commissioners shall hold |
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1997 | 1997 | | 1977at least 1 public hearing seeking input on the standard definition and assessment of “good moral |
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1998 | 1998 | | 1978character” for applicants of certification or licensure. In developing the standard definition and |
---|
1999 | 1999 | | 1979assessment of “good moral character”, the commissioners shall consider factors including, but |
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2000 | 2000 | | 1980not limited to: (i) the nature and gravity of any conduct that would cause concerns about an |
---|
2001 | 2001 | | 1981applicant’s moral character, including whether the conduct demonstrates a disregard for the |
---|
2002 | 2002 | | 1982welfare, safety or rights of another or disregard for honesty, integrity or trustworthiness; (ii) the |
---|
2003 | 2003 | | 1983nature of the job; (iii) the length of time that has passed since the conduct; (iv) the circumstances |
---|
2004 | 2004 | | 1984surrounding the conduct, including the age of the offender and contributing social conditions and |
---|
2005 | 2005 | | 1985biases; (v) evidence of rehabilitation, including subsequent work history and character |
---|
2006 | 2006 | | 1986references; and (vi) racial, ethnic and other inequities in the criminal justice system. |
---|
2007 | 2007 | | 1987 SECTION 97. The sixth paragraph of section 2 of said chapter 112, as so appearing, is |
---|
2008 | 2008 | | 1988hereby amended by striking out the last sentence and inserting in place thereof the following 93 of 119 |
---|
2009 | 2009 | | 1989sentence:- The renewal application shall be accompanied by a fee determined under the |
---|
2010 | 2010 | | 1990aforementioned provision and shall include the physician’s name, license number, home address, |
---|
2011 | 2011 | | 1991office address, specialties, the principal setting of their practice and whether they are an active or |
---|
2012 | 2012 | | 1992inactive practitioner. |
---|
2013 | 2013 | | 1993 SECTION 98. Said chapter 112 is hereby further amended by inserting after section 4 the |
---|
2014 | 2014 | | 1994following 2 sections:- |
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2015 | 2015 | | 1995 Section 4A. (a) For the purposes of this section and section 4B, the following words shall |
---|
2016 | 2016 | | 1996have the following meanings unless the context clearly requires otherwise: |
---|
2017 | 2017 | | 1997 “Clinician”, a physician, nurse, physician assistant, psychologist or independent clinical |
---|
2018 | 2018 | | 1998social worker, who is licensed to provide health services and registered in the commonwealth |
---|
2019 | 2019 | | 1999pursuant to this chapter to provide such services, and any other individual who is licensed to |
---|
2020 | 2020 | | 2000provide health services and registered in the commonwealth pursuant to this chapter to provide |
---|
2021 | 2021 | | 2001such services. |
---|
2022 | 2022 | | 2002 “Clinician with independent practice authority”, a physician registered to practice |
---|
2023 | 2023 | | 2003medicine in the commonwealth or a nurse practitioner, psychiatric nurse mental health clinical |
---|
2024 | 2024 | | 2004specialist or nurse anesthetist who is registered to practice nursing in the commonwealth and |
---|
2025 | 2025 | | 2005who has independent practice authority pursuant to sections 80E, 80H and 80J. |
---|
2026 | 2026 | | 2006 “Health care practice”, a business, regardless of form, through which a clinician with |
---|
2027 | 2027 | | 2007independent practice authority licensed by the board of registration in medicine or the board of |
---|
2028 | 2028 | | 2008registration in nursing offers health services; provided, however, that “health care practice” shall |
---|
2029 | 2029 | | 2009not include any entity that holds a license issued by the department of public health pursuant to |
---|
2030 | 2030 | | 2010sections 51, 51M, 51N or 52 of chapter 111. 94 of 119 |
---|
2031 | 2031 | | 2011 “Management services organization”, a business that provides management or |
---|
2032 | 2032 | | 2012administrative services to a provider or provider organization for compensation. |
---|
2033 | 2033 | | 2013 “Nurse anesthetist”, an advanced practice registered nurse who is authorized advanced |
---|
2034 | 2034 | | 2014nursing practice in the commonwealth pursuant to sections 80B and 80H. |
---|
2035 | 2035 | | 2015 “Nurse practitioner”, an advanced practice registered nurse who is authorized in |
---|
2036 | 2036 | | 2016advanced nursing practice in the commonwealth pursuant to sections 80B and 80E. |
---|
2037 | 2037 | | 2017 “Physician”, a doctor of medicine or doctor of osteopathy who is registered to practice |
---|
2038 | 2038 | | 2018medicine in the commonwealth pursuant to section 2. |
---|
2039 | 2039 | | 2019 “Provider”, shall have the same definition as in section 1 of chapter 6D. |
---|
2040 | 2040 | | 2020 “Provider organization”, shall have the same definition as in section 1 of chapter 6D; |
---|
2041 | 2041 | | 2021provided, however, that for the purposes of this section, “provider organization” shall not include |
---|
2042 | 2042 | | 2022a management services organization. |
---|
2043 | 2043 | | 2023 “Psychiatric nurse mental health clinical specialist”, an advanced practice registered |
---|
2044 | 2044 | | 2024nurse who is authorized in advanced nursing practice in the commonwealth pursuant to sections |
---|
2045 | 2045 | | 202580B, 80E and 80J. |
---|
2046 | 2046 | | 2026 (b) A clinician with independent practice authority may practice medicine or nursing at a |
---|
2047 | 2047 | | 2027health care practice that is: (i) wholly owned and controlled by 1 or more clinicians with |
---|
2048 | 2048 | | 2028independent practice authority who hold a certificate of registration that: (1) is issued by the |
---|
2049 | 2049 | | 2029board of registration in medicine or the board of registration in nursing pursuant to the |
---|
2050 | 2050 | | 2030requirements of sections 2 and 80B of this chapter; and (2) has not been suspended or revoked; |
---|
2051 | 2051 | | 2031or (ii) conducted through a business organization, a majority share of which is owned by 95 of 119 |
---|
2052 | 2052 | | 2032clinicians with independent practice authority or a provider or provider organization, and which |
---|
2053 | 2053 | | 2033is formed as: (1) a professional corporation pursuant to chapter 156A; (2) a nonprofit |
---|
2054 | 2054 | | 2034organization, a nonprofit hospital services corporation organized under chapter 176A or a |
---|
2055 | 2055 | | 2035nonprofit medical services corporation organized under chapter 176B; (3) a limited liability |
---|
2056 | 2056 | | 2036company organized under chapter 156C; provided, however, that there are no limited liability |
---|
2057 | 2057 | | 2037company’s provisions limiting or eliminating the licensee's liability for intentional tort or |
---|
2058 | 2058 | | 2038negligence; (4) a partnership organized under chapter 108A, including, but not limited to, a |
---|
2059 | 2059 | | 2039registered limited liability partnership; provided, however, that the partnership has no provisions |
---|
2060 | 2060 | | 2040limiting or eliminating the licensee's liability for intentional torts or negligence; or (5) an |
---|
2061 | 2061 | | 2041organization similar to those organizations described in clauses (i) to (iv), inclusive, and |
---|
2062 | 2062 | | 2042organized under a comparable law of any other jurisdiction within the United States; provided, |
---|
2063 | 2063 | | 2043however, that a majority share of the organization shall be owned by clinicians with independent |
---|
2064 | 2064 | | 2044practice authority or a provider organization. |
---|
2065 | 2065 | | 2045 (c) It shall constitute the unauthorized practice of medicine in violation of section 6 for |
---|
2066 | 2066 | | 2046any person or entity, on their own or in combination with another person or entity, to own a |
---|
2067 | 2067 | | 2047majority share in a health care practice other than provider or provider organization that is |
---|
2068 | 2068 | | 2048substantially engaged in delivering health care to patients in the commonwealth or a clinician |
---|
2069 | 2069 | | 2049with independent practice authority who: (i) holds a certificate of registration that is issued by |
---|
2070 | 2070 | | 2050the board of registration in medicine or the board of registration in nursing pursuant to the |
---|
2071 | 2071 | | 2051requirements of sections 2 or 80B and has not been suspended or revoked; and (ii) is |
---|
2072 | 2072 | | 2052substantially engaged in delivering health care to patients in the commonwealth through the |
---|
2073 | 2073 | | 2053practice or managing of the health care practice. This section shall not apply to a health care 96 of 119 |
---|
2074 | 2074 | | 2054facility or entity that holds a license issued by the department of public health pursuant to |
---|
2075 | 2075 | | 2055sections 51, 51M, 51N or 52 of chapter 111. |
---|
2076 | 2076 | | 2056 (d)(1) Nothing in this section shall prohibit a clinician with independent practice |
---|
2077 | 2077 | | 2057authority from practicing medicine or nursing as an employee of a health care facility or entity |
---|
2078 | 2078 | | 2058that holds a license issued by the department of public health pursuant to sections 51, 51M, 51N |
---|
2079 | 2079 | | 2059or 52 of chapter 111. |
---|
2080 | 2080 | | 2060 (2) Health care facilities or entities that hold a license issued by the department of public |
---|
2081 | 2081 | | 2061health pursuant to sections 51, 51M, 51N or 52 of chapter 111, providers and provider |
---|
2082 | 2082 | | 2062organizations shall not, themselves or through a management services organization that the |
---|
2083 | 2083 | | 2063provider organization fully or partially owns or controls, directly or indirectly interfere with, |
---|
2084 | 2084 | | 2064control or otherwise direct the professional judgment or clinical decisions of clinicians with |
---|
2085 | 2085 | | 2065independent practice authority who receive compensation, including, but not limited to, as |
---|
2086 | 2086 | | 2066employees or independent contractors, from the health care facility, provider, provider |
---|
2087 | 2087 | | 2067organization or an entity that the provider organization fully or partially owns or controls. |
---|
2088 | 2088 | | 2068Conduct prohibited under this paragraph shall include, but not be limited to, controlling, either |
---|
2089 | 2089 | | 2069directly or indirectly, through discipline, punishment, threats, adverse employment actions, |
---|
2090 | 2090 | | 2070coercion, retaliation or excessive pressure, regarding: (i) the amount of time spent with patients, |
---|
2091 | 2091 | | 2071including the time permitted to triage patients in the emergency department or evaluate admitted |
---|
2092 | 2092 | | 2072patients; (ii) the time period within which a patient must be discharged; (iii) decisions involving |
---|
2093 | 2093 | | 2073the patient’s clinical status, including, but not limited to, whether the patient should be kept in |
---|
2094 | 2094 | | 2074observation status, whether the patient should receive palliative care and where the patient |
---|
2095 | 2095 | | 2075should be placed upon discharge; (iv) the diagnosis, diagnostic terminology or codes that are |
---|
2096 | 2096 | | 2076entered into the medical record; or (v) any other conduct the department of public health 97 of 119 |
---|
2097 | 2097 | | 2077determines by regulation would interfere with, control or otherwise direct the professional |
---|
2098 | 2098 | | 2078judgement or clinical decisions of clinicians with independent practice authority. Such health |
---|
2099 | 2099 | | 2079care facilities or entities shall not limit the range of clinical orders available to clinicians either |
---|
2100 | 2100 | | 2080directly or by configuring the medical record to prohibit or significantly limit the clinical order |
---|
2101 | 2101 | | 2081options available. Nondisclosure or non-disparagement agreements regarding subsections (i) |
---|
2102 | 2102 | | 2082through (v), inclusive, between clinicians with independent practice authority and health care |
---|
2103 | 2103 | | 2083facilities or entities that hold a license issued by the department of public health pursuant to |
---|
2104 | 2104 | | 2084sections 51, 51M, 51N or 52 of chapter 111, providers, provider organizations or their corporate |
---|
2105 | 2105 | | 2085affiliates shall be considered void and unenforceable. If a court of competent jurisdiction finds a |
---|
2106 | 2106 | | 2086policy, contract or contract provision void and unenforceable pursuant to this section, the court |
---|
2107 | 2107 | | 2087shall award the plaintiff reasonable attorney’s fees and costs. Nothing in this section shall limit |
---|
2108 | 2108 | | 2088the ability of any person to bring any action relating to defamation, disclosure of confidential or |
---|
2109 | 2109 | | 2089proprietary information or trade secrets or similar torts. |
---|
2110 | 2110 | | 2090 (e) All health care practices shall provide written certification that the health care practice |
---|
2111 | 2111 | | 2091meets the requirements in this section to the board of registration in medicine or the board of |
---|
2112 | 2112 | | 2092registration in nursing at the time of formation and on a biennial basis thereafter. If a health care |
---|
2113 | 2113 | | 2093practice’s owners consist of individuals registered solely with the board of registration in |
---|
2114 | 2114 | | 2094medicine or the board of registration in nursing, the health care practice shall provide the |
---|
2115 | 2115 | | 2095certification to the applicable board. If the practice’s owners consist of individuals registered |
---|
2116 | 2116 | | 2096with both boards, the health care practice shall provide the certification to the board of |
---|
2117 | 2117 | | 2097registration in medicine, which shall transmit a copy to the board of registration in nursing. |
---|
2118 | 2118 | | 2098Health care practices shall, at the time that such clinicians with independent practice authority |
---|
2119 | 2119 | | 2099are hired or affiliated with the practice and within 30 days of providing certification to the 98 of 119 |
---|
2120 | 2120 | | 2100applicable board pursuant to this section, provide a copy of the most recent certification to all |
---|
2121 | 2121 | | 2101clinicians with independent practice authority who: (i) engage in providing health services at the |
---|
2122 | 2122 | | 2102health center practice; and (ii) do not hold any ownership interest in the health center practice. |
---|
2123 | 2123 | | 2103 (f) Health care practices shall file with the applicable board a registration application |
---|
2124 | 2124 | | 2104containing such information as the board may reasonably require, including, but not limited to: |
---|
2125 | 2125 | | 2105(i) the identity of the applicant and of the clinicians with independent practice authority which |
---|
2126 | 2126 | | 2106constitute the practice; (ii) any management services organization under contract with the health |
---|
2127 | 2127 | | 2107care practice; (iii) a certified copy of the health care practice’s certificate of organization, if any, |
---|
2128 | 2128 | | 2108as filed with the secretary of the commonwealth, or any applicable partnership agreement; (iv) |
---|
2129 | 2129 | | 2109the address of the health care practice; (v) the services provided by the health care practice; and |
---|
2130 | 2130 | | 2110(vi) any information the board, in consultation with the health policy commission and the center |
---|
2131 | 2131 | | 2111for health information and analysis, deems relevant for the state health plan and focused |
---|
2132 | 2132 | | 2112assessments pursuant to section 22 of chapter 6D and the health care resources inventory |
---|
2133 | 2133 | | 2113pursuant to section 9 of chapter 12C. The application shall be accompanied by a fee in an amount |
---|
2134 | 2134 | | 2114to be determined pursuant to section 3B of chapter 7. All health care practices registered in the |
---|
2135 | 2135 | | 2115commonwealth shall renew their certificates of registration with the applicable board every 2 |
---|
2136 | 2136 | | 2116years. The board shall share information relevant to the state health plan and focused |
---|
2137 | 2137 | | 2117assessments pursuant to section 22 of chapter 6D with the commission and information relevant |
---|
2138 | 2138 | | 2118to the health care resources inventory pursuant to section 9 of section 12C with the center. |
---|
2139 | 2139 | | 2119 (g) All health care practices with more than 1 clinician with independent practice |
---|
2140 | 2140 | | 2120authority that constitutes the practice shall designate a clinician with independent practice |
---|
2141 | 2141 | | 2121authority at the practice to serve as health care director; provided, however, that the designated |
---|
2142 | 2142 | | 2122clinician shall hold a certificate of registration that: (i) is issued by the board of registration in 99 of 119 |
---|
2143 | 2143 | | 2123medicine or the board of registration in nursing pursuant to the requirements of sections 2 or |
---|
2144 | 2144 | | 212480B; and (ii) has not been suspended or revoked. The director shall be responsible for |
---|
2145 | 2145 | | 2125implementing policies and procedures to ensure compliance with local ordinances and state and |
---|
2146 | 2146 | | 2126federal laws and regulations governing the practice of medicine or the practice of nursing, |
---|
2147 | 2147 | | 2127including regulations promulgated and policies established by the applicable board. The board |
---|
2148 | 2148 | | 2128may impose discipline against the licenses of the director and clinicians with independent |
---|
2149 | 2149 | | 2129practice authority who own and control the health care practice for failure of the health care |
---|
2150 | 2150 | | 2130practice to comply with local ordinances and state and federal laws and regulations governing the |
---|
2151 | 2151 | | 2131practice of medicine or the practice of nursing, including regulations promulgated and policies |
---|
2152 | 2152 | | 2132established by the applicable board. |
---|
2153 | 2153 | | 2133 (h) The board of registration in medicine and board of registration in nursing may |
---|
2154 | 2154 | | 2134promulgate regulations to establish minimum requirements for the conduct of a health care |
---|
2155 | 2155 | | 2135practice, including, but not limited to: (i) compliance with section 4A; (ii) maintenance and |
---|
2156 | 2156 | | 2136access to medical records; and (iii) in the event of a planned closure of the health care practice or |
---|
2157 | 2157 | | 2137an unplanned event that prevents the health care practice from continuing operations, the |
---|
2158 | 2158 | | 2138development of a continuity plan to: (1) ensure access to medical records, (2) provide notice to |
---|
2159 | 2159 | | 2139patients; and (3) assist patients with transitioning to a new provider. If a practice’s owners |
---|
2160 | 2160 | | 2140consist of individuals registered solely with the board of registration in medicine or the board of |
---|
2161 | 2161 | | 2141registration in nursing, the practice shall comply with the applicable board’s regulations. If the |
---|
2162 | 2162 | | 2142practice’s owners consist of individuals registered with both boards, the practice shall comply |
---|
2163 | 2163 | | 2143with the regulations issued by the board of registration in medicine. Each board shall consult |
---|
2164 | 2164 | | 2144with the other when promulgating regulations. 100 of 119 |
---|
2165 | 2165 | | 2145 Section 4B. (a) It shall be a violation of this section for a management services |
---|
2166 | 2166 | | 2146organization to exercise control over clinical decisions. A management services organization, or |
---|
2167 | 2167 | | 2147any other organization that is not a health care practice, that does any of the following shall be |
---|
2168 | 2168 | | 2148considered to have control over the clinical decisions of the health care practice: (i) managing, |
---|
2169 | 2169 | | 2149supervising, evaluating or recommending promotion or discipline of any owner of or clinician |
---|
2170 | 2170 | | 2150with independent practice authority associated with the health care practice; (ii) negotiating with |
---|
2171 | 2171 | | 2151third-party payers on behalf of a health care practice without first obtaining informed consent |
---|
2172 | 2172 | | 2152from the health care practice’s owners; (iii) advertising or otherwise presenting as a health care |
---|
2173 | 2173 | | 2153practice or provider of health care services; or (iv) performing any other functions that the |
---|
2174 | 2174 | | 2154department of public health determines, by regulation, confers to a management services |
---|
2175 | 2175 | | 2155organization or any other entity that is not a health care practice the ability to control the clinical |
---|
2176 | 2176 | | 2156decisions of the health care practice or its clinicians with independent practice authority. |
---|
2177 | 2177 | | 2157 (b) A health care practice shall maintain ultimate decision-making authority over: (i) |
---|
2178 | 2178 | | 2158personnel decisions involving clinicians, including, but not limited to, employment status, |
---|
2179 | 2179 | | 2159compensation, hours or working conditions; (ii) coding or billing decisions; (iii) the selection and |
---|
2180 | 2180 | | 2160use of property, including, but not limited to, real property, medical equipment or medical |
---|
2181 | 2181 | | 2161supplies; (iv) the number of patients seen in a given period of time or the amount of time spent |
---|
2182 | 2182 | | 2162with each patient; (v) the appropriate diagnostic test for medical conditions; (vi) the use of |
---|
2183 | 2183 | | 2163patient medical records; (vii) referral decisions; or (viii) any other function or decision that the |
---|
2184 | 2184 | | 2164department of public health determines, by regulation, confers to a management services |
---|
2185 | 2185 | | 2165organization or any other entity that is not a health care practice the ability to control the clinical |
---|
2186 | 2186 | | 2166decisions of a health care practice or its clinicians with independent practice authority. 101 of 119 |
---|
2187 | 2187 | | 2167 (c) It shall be a violation of this section for a management services organization or any |
---|
2188 | 2188 | | 2168other entity that is not a health care practice to include in an agreement with any health care |
---|
2189 | 2189 | | 2169practice provisions that would: (i) restrict the ability of the health care practice or practice owner |
---|
2190 | 2190 | | 2170to exercise complete, unfettered control and discretion over the finances or capital of the health |
---|
2191 | 2191 | | 2171care practice, including, but not limited to, restricting the ability to create, buy or sell stock, issue |
---|
2192 | 2192 | | 2172dividends or sell the health care practice; (ii) restrict the ability of a person who owns stock in |
---|
2193 | 2193 | | 2173the health care practice to transfer, alienate or otherwise exercise unfettered discretion and |
---|
2194 | 2194 | | 2174control over their stock; (iii) restrict in any way the ability of the health care practice or |
---|
2195 | 2195 | | 2175clinicians with independent practice authority associated with the health care practice to provide |
---|
2196 | 2196 | | 2176health care services in any place, for any entity or in any form otherwise permitted by law; (iv) |
---|
2197 | 2197 | | 2177restrict the ability of the health care practice to contract with another management services |
---|
2198 | 2198 | | 2178organization for management or administrative services upon expiration of the current contract; |
---|
2199 | 2199 | | 2179(v) limit the ability of the health care practice or the practice’s owners, employees or agents to |
---|
2200 | 2200 | | 2180publicly discuss the business relationship between the health care practice and the management |
---|
2201 | 2201 | | 2181services organization; provided, however, that this provision shall not limit the ability of any |
---|
2202 | 2202 | | 2182person to bring any action relating to defamation, disclosure of confidential or proprietary |
---|
2203 | 2203 | | 2183information or trade secrets or similar torts; (vi) limit access to, take control from or otherwise |
---|
2204 | 2204 | | 2184obscure from any clinicians providing services in connection with the health care practice, the |
---|
2205 | 2205 | | 2185price, rate or amount of the charges for their services; (vii) establish, supervise, manage or |
---|
2206 | 2206 | | 2186otherwise control the health care practice’s officers or directors; or (viii) create any other |
---|
2207 | 2207 | | 2187situation the department of public health determines, by regulation, could create the possibility of |
---|
2208 | 2208 | | 2188allowing the management services organization to control the clinical decisions of the health care |
---|
2209 | 2209 | | 2189practice. 102 of 119 |
---|
2210 | 2210 | | 2190 (d) No management services organization shall have any ownership interest in or direct |
---|
2211 | 2211 | | 2191or indirect control over health care practices for which the management services organization |
---|
2212 | 2212 | | 2192provides services. No health care practice shall have any ownership interest in or direct or |
---|
2213 | 2213 | | 2193indirect control over a management services organization unless the management services |
---|
2214 | 2214 | | 2194organization is fully owned, alone or in combination, by: (i) health care practices substantially |
---|
2215 | 2215 | | 2195engaged in delivering health care to patients in the commonwealth; (ii) clinicians with |
---|
2216 | 2216 | | 2196independent practice authority who both: (1) hold a certificate of registration that is issued by the |
---|
2217 | 2217 | | 2197board of registration in medicine or the board of registration in nursing pursuant to the |
---|
2218 | 2218 | | 2198requirements of sections 2 and 80B and has not been suspended or revoked; and (2) are |
---|
2219 | 2219 | | 2199substantially engaged in delivering health care to patients in the commonwealth; or (iii) provider |
---|
2220 | 2220 | | 2200organizations. For the purposes of this subsection, a de minimis interest in a publicly traded |
---|
2221 | 2221 | | 2201company held in a mutual fund, index fund or similar financial instrument shall not be |
---|
2222 | 2222 | | 2202considered an ownership interest. |
---|
2223 | 2223 | | 2203 (e) No person may serve as a director, officer, employee or contractor for both a |
---|
2224 | 2224 | | 2204management services organization and a health care practice for which the management services |
---|
2225 | 2225 | | 2205organization provides services; provided, however, that this subsection shall not apply when the |
---|
2226 | 2226 | | 2206management services organization is fully owned, alone or in combination, by: (i) health care |
---|
2227 | 2227 | | 2207practices substantially engaged in delivering health care to patients in the commonwealth; (ii) |
---|
2228 | 2228 | | 2208clinicians with independent practice authority who both: (1) hold a certificate of registration that |
---|
2229 | 2229 | | 2209is issued by the board of registration in medicine or the board of registration in nursing pursuant |
---|
2230 | 2230 | | 2210to the requirements of sections 2 and 80B and has not been suspended or revoked; and (2) are |
---|
2231 | 2231 | | 2211substantially engaged in delivering health care to patients in the commonwealth; or (iii) provider |
---|
2232 | 2232 | | 2212organizations. 103 of 119 |
---|
2233 | 2233 | | 2213 (f) A violation of this section shall constitute the unauthorized practice of medicine in |
---|
2234 | 2234 | | 2214violation of section 6 or the unauthorized practice of nursing in violation of section 80E, 80H or |
---|
2235 | 2235 | | 221580J. Any provision of a contract or agreement that has the effect of violating this section shall be |
---|
2236 | 2236 | | 2216void and unenforceable. If a court of competent jurisdiction finds a policy, contract or contract |
---|
2237 | 2237 | | 2217provision void and unenforceable pursuant to this section, the court shall award the plaintiff |
---|
2238 | 2238 | | 2218reasonable attorney’s fees and costs. |
---|
2239 | 2239 | | 2219 (g) The department of public health, in consultation with the health policy commission, |
---|
2240 | 2240 | | 2220shall promulgate regulations to effectuate the purposes of this section. |
---|
2241 | 2241 | | 2221 SECTION 99. Section 1 of chapter 175 of the General Laws, as so appearing, is hereby |
---|
2242 | 2242 | | 2222amended by inserting after the definition of “Foreign company” the following definition:- |
---|
2243 | 2243 | | 2223 “Health insurance company”, a company that engages in the business of health insurance. |
---|
2244 | 2244 | | 2224 SECTION 100. Said section 1 of said chapter 175, as so appearing, is hereby further |
---|
2245 | 2245 | | 2225amended by inserting after the definition of “Net value of policies” the following definition:- |
---|
2246 | 2246 | | 2226 “Party of record”, for the purpose of a review by the commissioner of a written |
---|
2247 | 2247 | | 2227agreement for a merger or consolidation of 2 or more health insurance companies, the health |
---|
2248 | 2248 | | 2228policy commission, the center for health information and analysis, the attorney general, the |
---|
2249 | 2249 | | 2229center for health information and analysis and any government agency with relevant oversight or |
---|
2250 | 2250 | | 2230licensure authority over the proposed project or components therein. |
---|
2251 | 2251 | | 2231 SECTION 101. The fourth paragraph of section 5 of chapter 176A of the General Laws, |
---|
2252 | 2252 | | 2232as so appearing, is hereby amended by inserting after the fourth sentence the following |
---|
2253 | 2253 | | 2233sentence:- In determining whether rates of payment under this section are excessive, the 104 of 119 |
---|
2254 | 2254 | | 2234commissioner shall consider the affordability for consumers and purchasers of health insurance |
---|
2255 | 2255 | | 2235products; provided, however, that the commissioner shall not disapprove a carrier’s rates solely |
---|
2256 | 2256 | | 2236on the basis of the affordability standard. |
---|
2257 | 2257 | | 2237 SECTION 102. The second paragraph of section 6 of said chapter 176A, as so appearing, |
---|
2258 | 2258 | | 2238is hereby amended by adding the following sentence:- In determining whether the rates of |
---|
2259 | 2259 | | 2239payment under a contract are excessive under this section, the commissioner shall consider the |
---|
2260 | 2260 | | 2240affordability for consumers and purchasers of health insurance products; provided, however, that |
---|
2261 | 2261 | | 2241the commissioner shall not disapprove a carrier’s rates solely on the basis of the affordability |
---|
2262 | 2262 | | 2242standard. |
---|
2263 | 2263 | | 2243 SECTION 103. The third paragraph of section 10 of said chapter 176A, as so appearing, |
---|
2264 | 2264 | | 2244is hereby amended by inserting after the first sentence the following sentence:- In determining |
---|
2265 | 2265 | | 2245whether the rates of payment under a contract are excessive under this section, the commissioner |
---|
2266 | 2266 | | 2246shall consider the affordability for consumers and purchasers of health insurance products; |
---|
2267 | 2267 | | 2247provided, however, that the commissioner shall not disapprove a carrier’s rates solely on the |
---|
2268 | 2268 | | 2248basis of the affordability standard. |
---|
2269 | 2269 | | 2249 SECTION 104. The second paragraph of section 4 of chapter 176B of the General Laws, |
---|
2270 | 2270 | | 2250as so appearing, is hereby amended by inserting after the second sentence the following |
---|
2271 | 2271 | | 2251sentence:- In determining whether the rates of payment under an agreement are excessive under |
---|
2272 | 2272 | | 2252this section, the commissioner shall consider the affordability for consumers and purchasers of |
---|
2273 | 2273 | | 2253health insurance products; provided, however, that the commissioner shall not disapprove a |
---|
2274 | 2274 | | 2254carrier’s rates solely on the basis of the affordability standard. 105 of 119 |
---|
2275 | 2275 | | 2255 SECTION 105. The first paragraph of section 16 of chapter 176G of the General Laws, |
---|
2276 | 2276 | | 2256as so appearing, is hereby amended by inserting after the second sentence the following |
---|
2277 | 2277 | | 2257sentence:- In determining whether the rates of payment under a contract are excessive under this |
---|
2278 | 2278 | | 2258section, the commissioner shall consider the affordability for consumers and purchasers of health |
---|
2279 | 2279 | | 2259insurance products; provided, however, that the commissioner shall not disapprove a carrier’s |
---|
2280 | 2280 | | 2260rates solely on the basis of the affordability standard. |
---|
2281 | 2281 | | 2261 SECTION 106. Subsection (c) of section 6 of chapter 176J of the General Laws, as so |
---|
2282 | 2282 | | 2262appearing, is hereby amended by inserting after the second sentence the following sentence:- In |
---|
2283 | 2283 | | 2263determining whether the proposed changes to base rates of payment are excessive under this |
---|
2284 | 2284 | | 2264section, the commissioner shall consider the affordability for consumers and purchasers of health |
---|
2285 | 2285 | | 2265insurance products; provided, however, that the commissioner shall not disapprove a carrier’s |
---|
2286 | 2286 | | 2266proposed changes to base rates solely on the basis of the affordability standard. |
---|
2287 | 2287 | | 2267 SECTION 107. The second paragraph of subsection (g) of section 7 of chapter 176K of |
---|
2288 | 2288 | | 2268the General Laws, as so appearing, is hereby amended by adding the following sentence:- In |
---|
2289 | 2289 | | 2269determining whether rates of payment are excessive under this section, the commissioner shall |
---|
2290 | 2290 | | 2270consider the affordability for consumers and purchasers of health insurance products; provided, |
---|
2291 | 2291 | | 2271however, that the commissioner shall not disapprove a carrier’s rates solely on the basis of the |
---|
2292 | 2292 | | 2272affordability standard. |
---|
2293 | 2293 | | 2273 SECTION 108. Section 12 of chapter 176O of the General Laws, as so appearing, is |
---|
2294 | 2294 | | 2274amended by adding the following subsections:- |
---|
2295 | 2295 | | 2275 (g) For an insured member who is stable on a treatment, service or course of medication |
---|
2296 | 2296 | | 2276as determined by a health care provider and approved for coverage by a previous carrier or health 106 of 119 |
---|
2297 | 2297 | | 2277benefit plan, a carrier or utilization review organization shall not restrict coverage of such |
---|
2298 | 2298 | | 2278treatment, service or course of medication for at least 90 days upon the insured member’s |
---|
2299 | 2299 | | 2279enrollment unless the previously approved admission, procedure, treatment, service or course of |
---|
2300 | 2300 | | 2280medication is not a covered benefit under the insured member’s new plan; provided, however, |
---|
2301 | 2301 | | 2281that a carrier may condition coverage of continued treatment by a provider under this subsection |
---|
2302 | 2302 | | 2282upon the provider’s agreeing to accept reimbursement from the carrier at the average in-network |
---|
2303 | 2303 | | 2283rate and not to impose cost sharing with respect to the insured in an amount that would exceed |
---|
2304 | 2304 | | 2284the cost sharing imposed if the provider were in network. |
---|
2305 | 2305 | | 2285 (h) Preauthorization approval issued by a carrier for a prescribed maintenance medication |
---|
2306 | 2306 | | 2286shall be valid for the length of the prescription, as written by the prescriber, up to 1 year. For the |
---|
2307 | 2307 | | 2287purposes of this section, “maintenance medication” shall mean a prescribed treatment services, |
---|
2308 | 2308 | | 2288or course of medication intended for chronic disease management. |
---|
2309 | 2309 | | 2289 SECTION 109. The General Laws are hereby amended by inserting after chapter 176X |
---|
2310 | 2310 | | 2290the following chapter:- |
---|
2311 | 2311 | | 2291 Chapter 176Y. LICENSING AND REGULATION OF PHARMACY BENEFIT |
---|
2312 | 2312 | | 2292MANAGERS. |
---|
2313 | 2313 | | 2293 Section 1. As used in this chapter, the following words shall have the following meanings |
---|
2314 | 2314 | | 2294unless the context clearly requires otherwise: |
---|
2315 | 2315 | | 2295 “Carrier”, an insurer licensed or otherwise authorized to transact accident or health |
---|
2316 | 2316 | | 2296insurance under chapter 175, a nonprofit hospital service corporation organized under chapter |
---|
2317 | 2317 | | 2297176A, a nonprofit medical service corporation organized under chapter 176B, a health |
---|
2318 | 2318 | | 2298maintenance organization organized under chapter 176G or an organization entering into a 107 of 119 |
---|
2319 | 2319 | | 2299preferred provider arrangement under chapter 176I; provided, however, that “carrier” shall not |
---|
2320 | 2320 | | 2300include an employer purchasing coverage or acting on behalf of its employees or the employees |
---|
2321 | 2321 | | 2301of a subsidiary or affiliated corporation of the employer; and provided further, that unless |
---|
2322 | 2322 | | 2302otherwise provided, “carrier” shall not include any entity to the extent it offers a policy, |
---|
2323 | 2323 | | 2303certificate or contract that provides coverage solely for dental care services or vision care |
---|
2324 | 2324 | | 2304services. |
---|
2325 | 2325 | | 2305 “Center”, the center for health information and analysis established under chapter 12C. |
---|
2326 | 2326 | | 2306 “Commissioner”, the commissioner of insurance. |
---|
2327 | 2327 | | 2307 “Division”, the division of insurance. |
---|
2328 | 2328 | | 2308 “Health benefit plan”, a contract, certificate or agreement entered into, offered or issued |
---|
2329 | 2329 | | 2309by a carrier to provide, deliver, arrange for, pay for or reimburse any of the costs of health care |
---|
2330 | 2330 | | 2310services; provided, however, that the commissioner may, by regulation, define other health |
---|
2331 | 2331 | | 2311coverage as a “health benefit plan” for the purposes of this chapter. |
---|
2332 | 2332 | | 2312 “Pharmacy”, a physical or electronic facility under the direction or supervision of a |
---|
2333 | 2333 | | 2313registered pharmacist that is authorized to dispense prescription drugs and has entered into a |
---|
2334 | 2334 | | 2314network contract with a pharmacy benefit manager or a carrier. |
---|
2335 | 2335 | | 2315 “Pharmacy benefit manager”, a person, business or other entity, however organized, that |
---|
2336 | 2336 | | 2316directly or through a subsidiary provides pharmacy benefit management services for prescription |
---|
2337 | 2337 | | 2317drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self- |
---|
2338 | 2338 | | 2318insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit |
---|
2339 | 2339 | | 2319management services shall include, but not be limited to: (i) the processing and payment of 108 of 119 |
---|
2340 | 2340 | | 2320claims for prescription drugs; (ii) the performance of drug utilization review; (iii) the processing |
---|
2341 | 2341 | | 2321of drug prior authorization requests; (iv) pharmacy contracting; (v) the adjudication of appeals or |
---|
2342 | 2342 | | 2322grievances related to prescription drug coverage contracts; (vi) formulary administration; (vii) |
---|
2343 | 2343 | | 2323drug benefit design; (viii) mail and specialty drug pharmacy services; (ix) cost containment; (x) |
---|
2344 | 2344 | | 2324clinical, safety and adherence programs for pharmacy services; and (xi) management of the cost |
---|
2345 | 2345 | | 2325of covered prescription drugs; and provided further, that “pharmacy benefit manager” shall not |
---|
2346 | 2346 | | 2326include a health benefit plan sponsor unless otherwise specified by the division. |
---|
2347 | 2347 | | 2327 Section 2. (a) No person, business or other entity shall establish or operate as a pharmacy |
---|
2348 | 2348 | | 2328benefit manager without obtaining a license from the division pursuant to this section. A license |
---|
2349 | 2349 | | 2329may be granted if the division is satisfied that the applicant possesses the necessary organization, |
---|
2350 | 2350 | | 2330background expertise and financial integrity to supply the services sought to be offered. A |
---|
2351 | 2351 | | 2331pharmacy benefit manager license shall be valid for a period of 3 years and shall be renewable |
---|
2352 | 2352 | | 2332for additional 3-year periods. The commissioner shall charge application and renewal fees in the |
---|
2353 | 2353 | | 2333amount of $25,000. In no event may these fees, when combined with the assessment of |
---|
2354 | 2354 | | 2334pharmacy benefit managers in section 6 of chapter 6D and section 7 of chapter 12C, exceed the |
---|
2355 | 2355 | | 2335commonwealth’s estimated operating expenses of the pharmacy benefit manager licensure |
---|
2356 | 2356 | | 2336program. |
---|
2357 | 2357 | | 2337 (b) A license granted pursuant to this section and any rights or interests therein shall not |
---|
2358 | 2358 | | 2338be transferable. |
---|
2359 | 2359 | | 2339 (c) A person, business or other entity licensed as a pharmacy benefit manager shall |
---|
2360 | 2360 | | 2340submit data and reporting information to the center according to the standards and methods |
---|
2361 | 2361 | | 2341specified by the center pursuant to section 10A of chapter 12C. 109 of 119 |
---|
2362 | 2362 | | 2342 (d) The division may issue or renew a license pursuant to this section, subject to |
---|
2363 | 2363 | | 2343restrictions in order to protect the interests of consumers. Such restrictions may include: (i) |
---|
2364 | 2364 | | 2344limiting the type of services that a license holder may provide; (ii) limiting the activities in which |
---|
2365 | 2365 | | 2345the license holder may be engaged; or (iii) addressing conflicts of interest between pharmacy |
---|
2366 | 2366 | | 2346benefit managers and health plan sponsors. |
---|
2367 | 2367 | | 2347 (e) The division shall develop an application for the licensure of pharmacy benefit |
---|
2368 | 2368 | | 2348managers that shall include, but not be limited to: (i) the name of the applicant or pharmacy |
---|
2369 | 2369 | | 2349benefit manage; (ii) the address and contact telephone number for the applicant; (iii) the name |
---|
2370 | 2370 | | 2350and address of the agent of the applicant or pharmacy benefit manager for service of process in |
---|
2371 | 2371 | | 2351the commonwealth; (iv) the name and address of any person with management or control over |
---|
2372 | 2372 | | 2352the applicant or pharmacy benefit manager; and (v) any audited financial statements specific to |
---|
2373 | 2373 | | 2353the applicant or pharmacy benefit manager. An applicant or pharmacy benefit manager shall |
---|
2374 | 2374 | | 2354inform the division any material change to the information contained in its application, certified |
---|
2375 | 2375 | | 2355by an officer of the applicant, within 30 days of such a change; provided, however, that, once |
---|
2376 | 2376 | | 2356licensed, a pharmacy benefit manager shall inform the division of any material change to the |
---|
2377 | 2377 | | 2357information contained in its application, certified by an officer of the pharmacy benefit manager. |
---|
2378 | 2378 | | 2358 (f) The division may suspend, revoke, refuse to issue or renew or place on probation an |
---|
2379 | 2379 | | 2359application or pharmacy benefit manager license for cause, which shall include, but not be |
---|
2380 | 2380 | | 2360limited to: (i) the applicant or pharmacy benefit manager engaging in fraudulent activity that is |
---|
2381 | 2381 | | 2361found by a court of law to be a violation of state or federal law; (ii) the division receiving |
---|
2382 | 2382 | | 2362consumer complaints that justify an action under this chapter to protect the health, safety and |
---|
2383 | 2383 | | 2363interests of consumers; (iii) the applicant or pharmacy benefit manager failing to pay an |
---|
2384 | 2384 | | 2364application or renewal fee for a license; (iv) the applicant or pharmacy benefit manager failing to 110 of 119 |
---|
2385 | 2385 | | 2365comply with reporting requirements of the center under section 10A of chapter 12C; or (v) the |
---|
2386 | 2386 | | 2366applicant or pharmacy benefit manager failing to comply with a requirement of this chapter. |
---|
2387 | 2387 | | 2367 The division shall provide written notice to the applicant or pharmacy benefit manager |
---|
2388 | 2388 | | 2368and advise in writing of the reason for any suspension, revocation, refusal to issue or renew or |
---|
2389 | 2389 | | 2369placement on probation of an application or pharmacy benefit manager license. A copy of the |
---|
2390 | 2390 | | 2370notice shall be forwarded to the center. The applicant or pharmacy benefit manager may make a |
---|
2391 | 2391 | | 2371written demand upon the division within 30 days of receipt of such notice for a hearing before |
---|
2392 | 2392 | | 2372the division to determine the reasonableness of the division’s action. The hearing shall be held |
---|
2393 | 2393 | | 2373pursuant to chapter 30A. |
---|
2394 | 2394 | | 2374 The division shall not suspend or cancel a license unless the division has first afforded |
---|
2395 | 2395 | | 2375the pharmacy benefit manager an opportunity for a hearing pursuant to said chapter 30A. |
---|
2396 | 2396 | | 2376 (g) If a person, business or other entity performs the functions of a pharmacy benefit |
---|
2397 | 2397 | | 2377manager in violation of this chapter, the person, business or other entity shall be subject to a fine |
---|
2398 | 2398 | | 2378of $5,000 per day for each day that the person, business or other entity is found to be in violation. |
---|
2399 | 2399 | | 2379 (h) A pharmacy benefit manager licensed under this section shall notify a health carrier |
---|
2400 | 2400 | | 2380client in writing of any activity, policy, practice contract or arrangement of the pharmacy benefit |
---|
2401 | 2401 | | 2381manager that directly or indirectly presents any conflict of interest to the pharmacy benefit |
---|
2402 | 2402 | | 2382manager’s relationship with or obligation to the health carrier client. |
---|
2403 | 2403 | | 2383 (i) The division shall promulgate regulations and adopt policies and procedures necessary |
---|
2404 | 2404 | | 2384to implement this section. 111 of 119 |
---|
2405 | 2405 | | 2385 SECTION 110. There shall be a task force to: (i) study primary care access, delivery and |
---|
2406 | 2406 | | 2386payment in the commonwealth; (ii) develop and issue recommendations to stabilize and |
---|
2407 | 2407 | | 2387strengthen the primary care system and the primary care workforce; and (iii) increase the |
---|
2408 | 2408 | | 2388financial investment in and patient access to primary care across the commonwealth. |
---|
2409 | 2409 | | 2389 (b) The task force shall consist of: the secretary of health and human services or a |
---|
2410 | 2410 | | 2390designee, who shall serve as co-chair; the executive director of the health policy commission or a |
---|
2411 | 2411 | | 2391designee, who shall serve as co-chair; the assistant secretary for MassHealth or a designee; the |
---|
2412 | 2412 | | 2392executive director of the center for health information and analysis or a designee; the |
---|
2413 | 2413 | | 2393commissioner of insurance or a designee; the chairs of the joint committee on health care |
---|
2414 | 2414 | | 2394financing or their designees; 1 member from the Massachusetts Academy of Family Physicians, |
---|
2415 | 2415 | | 2395Inc.; 1 member from the Massachusetts Chapter of the American Academy of Pediatrics; 1 |
---|
2416 | 2416 | | 2396member from the Massachusetts Medical Society with expertise in primary care; 1 member from |
---|
2417 | 2417 | | 2397the Massachusetts Coalition of Nurse Practitioners, Inc. with expertise in primary care or in |
---|
2418 | 2418 | | 2398delivering care in a community health center; 1 member from the Massachusetts Association of |
---|
2419 | 2419 | | 2399Physician Assistants, Inc. with expertise in primary care; 1 member from the National |
---|
2420 | 2420 | | 2400Association of Social Workers, Inc. – Massachusetts Chapter with expertise in behavioral health |
---|
2421 | 2421 | | 2401in a primary care setting; 1 member from the Massachusetts League of Community Health |
---|
2422 | 2422 | | 2402Centers, Inc.; 1 member from the Massachusetts Health and Hospital Association, Inc.; 1 |
---|
2423 | 2423 | | 2403member from the Massachusetts Association of Health Plans, Inc.; 1 member from Blue Cross |
---|
2424 | 2424 | | 2404and Blue Shield of Massachusetts, Inc.; 1 member from the Association Industries of |
---|
2425 | 2425 | | 2405Massachusetts; 1 member from the Retailers Association of Massachusetts, Inc.; 1 member from |
---|
2426 | 2426 | | 2406Health Care For All, Inc.; 1 member from the Massachusetts Chapter of the American College of 112 of 119 |
---|
2427 | 2427 | | 2407Physicians; 1 member from the Massachusetts Primary Care Alliance for Patients; and 1 member |
---|
2428 | 2428 | | 2408from Massachusetts Health Quality Partners, Inc. |
---|
2429 | 2429 | | 2409 (c) The task force shall develop recommendations to: (i) define primary care services, |
---|
2430 | 2430 | | 2410codes and providers; (ii) develop a standardized set of data reporting requirements for private |
---|
2431 | 2431 | | 2411and public health care payers, providers and provider organizations to enable the commonwealth |
---|
2432 | 2432 | | 2412and private and public health care payers to track payments for primary care services, including, |
---|
2433 | 2433 | | 2413but not limited to, fee-for-service, prospective payments, value-based payments and grants to |
---|
2434 | 2434 | | 2414primary care providers, fees levied on a primary care provider by a provider organization or |
---|
2435 | 2435 | | 2415hospital system of which the primary care provider is affiliated and provider spending on |
---|
2436 | 2436 | | 2416primary care services; (iii) establish a primary care spending target for private and public health |
---|
2437 | 2437 | | 2417care payers that reflects the cost to deliver evidence-based, equitable and culturally competent |
---|
2438 | 2438 | | 2418primary care; (iv) propose payment models to increase private and public reimbursement for |
---|
2439 | 2439 | | 2419primary care services; (v) assess the impact of health plan design on health equity and patient |
---|
2440 | 2440 | | 2420access to primary care services; (vi) monitor and track the needs of and service delivery to |
---|
2441 | 2441 | | 2421residents of the commonwealth; and (vii) create a short-term and long-term workforce |
---|
2442 | 2442 | | 2422development plan to increase the supply and distribution of and improve working conditions of |
---|
2443 | 2443 | | 2423primary care clinicians and other primary care workers. The task force may make additional |
---|
2444 | 2444 | | 2424recommendations and propose legislation necessary to carry out its recommendations. |
---|
2445 | 2445 | | 2425 (d) The task force shall, in consultation with the center for health information and |
---|
2446 | 2446 | | 2426analysis, define the data required to satisfy the contents of this section. The center for health |
---|
2447 | 2447 | | 2427information and analysis shall adopt regulations to require providers and private and public |
---|
2448 | 2448 | | 2428health care payers to submit data or information necessary for the task force to fulfill its duties |
---|
2449 | 2449 | | 2429with this section. Any data collected shall be public and available through the Massachusetts 113 of 119 |
---|
2450 | 2450 | | 2430Primary Care Dashboard maintained by the center and Massachusetts Health Quality Partners, |
---|
2451 | 2451 | | 2431Inc. |
---|
2452 | 2452 | | 2432 (e) Not later than March 15, 2025, the task force shall issue its report of the findings and |
---|
2453 | 2453 | | 2433recommendations under clauses (i) and (ii) of subsection (c) with the clerks of the senate and the |
---|
2454 | 2454 | | 2434house of representatives, the senate and house committees on ways and means, the joint |
---|
2455 | 2455 | | 2435committee on health care financing, the center for health information and analysis, the health |
---|
2456 | 2456 | | 2436policy commission and the division of insurance. |
---|
2457 | 2457 | | 2437 (f) Not later than June 15, 2025, the task force shall issue its report of the findings and |
---|
2458 | 2458 | | 2438recommendations under clause (iii) of subsection (c) with the clerks of the senate and the house |
---|
2459 | 2459 | | 2439of representatives, the senate and house committees on ways and means, the joint committee on |
---|
2460 | 2460 | | 2440health care financing, the center for health information and analysis, the health policy |
---|
2461 | 2461 | | 2441commission and the division of insurance. |
---|
2462 | 2462 | | 2442 (g) Not later than September 15, 2025, the task force shall issue its report of the findings |
---|
2463 | 2463 | | 2443and recommendations under clauses (iv) and (v) of subsection (c) with the clerks of the senate |
---|
2464 | 2464 | | 2444and the house of representatives, the senate and house committees on ways and means, the joint |
---|
2465 | 2465 | | 2445committee on health care financing, the center for health information and analysis, the health |
---|
2466 | 2466 | | 2446policy commission and the division of insurance. |
---|
2467 | 2467 | | 2447 (h) Not later than December 15, 2025, the task force shall issue its report of the findings |
---|
2468 | 2468 | | 2448and recommendations under clauses (vi) and (vii) of subsection (c) with the clerks of the senate |
---|
2469 | 2469 | | 2449and the house of representatives, the senate and house committees on ways and means, the joint |
---|
2470 | 2470 | | 2450committee on health care financing, the center for health information and analysis, the health |
---|
2471 | 2471 | | 2451policy commission and the division of insurance. 114 of 119 |
---|
2472 | 2472 | | 2452 SECTION 111. (a) There shall be a task force to study the use of prior authorization for |
---|
2473 | 2473 | | 2453health care services and its impact on overall costs in the health care system, and delivery of and |
---|
2474 | 2474 | | 2454access to high quality health care. The task force shall consist of 11 members: the executive |
---|
2475 | 2475 | | 2455director of the health policy commission or a designee, who shall serve as co-chair; the |
---|
2476 | 2476 | | 2456commissioner of insurance or a designee, who shall serve as co-chair; the assistant secretary for |
---|
2477 | 2477 | | 2457MassHealth; the executive director of the group insurance commission; 1 representative from the |
---|
2478 | 2478 | | 2458Massachusetts Association of Health Plans, Inc.; 1 representative from Blue Cross and Blue |
---|
2479 | 2479 | | 2459Shield of Massachusetts, Inc.; 1 representative from the Massachusetts Medical Society; 1 |
---|
2480 | 2480 | | 2460representative from the Massachusetts Health and Hospital Association, Inc.; 1 representative |
---|
2481 | 2481 | | 2461from the Massachusetts Academy of Family Physicians, Inc.; 1 representative from the |
---|
2482 | 2482 | | 2462Massachusetts League of Community Health Centers, Inc.; 1 representative from Massachusetts |
---|
2483 | 2483 | | 2463Taxpayers Foundation, Inc.; 1 representative from Associated Industries of Massachusetts; and 1 |
---|
2484 | 2484 | | 2464representative from Health Care For All, Inc. |
---|
2485 | 2485 | | 2465 (b) The task force shall analyze: (i) the services, treatments and medications that require |
---|
2486 | 2486 | | 2466prior authorization by payers in Massachusetts; (ii) the factors used by payers to determine |
---|
2487 | 2487 | | 2467whether a service, treatment or medication is appropriate for prior authorization, including |
---|
2488 | 2488 | | 2468considerations of potential for provider abrasion, adverse impacts on health outcomes, the |
---|
2489 | 2489 | | 2469availability, and comparative cost and effectiveness of alternative treatment options and risk of |
---|
2490 | 2490 | | 2470provider overuse of the treatment; (iii) the processes used by payers to obtain prior authorization |
---|
2491 | 2491 | | 2471for a service, treatment or medication; (iv) the potential for streamlining prior authorization |
---|
2492 | 2492 | | 2472processes using automation, electronic submissions, gold carding or other means; (v) actuarial |
---|
2493 | 2493 | | 2473analysis of the impact of prior authorization requirements on the commonwealth’s efforts to meet |
---|
2494 | 2494 | | 2474the health care cost benchmark established under section 9 of chapter 6D; (vi) any state and 115 of 119 |
---|
2495 | 2495 | | 2475federal laws requiring or limiting prior authorization by public or private payers for a service, |
---|
2496 | 2496 | | 2476treatment or medication; (vii) the feasibility of an easily accessible, publicly available website |
---|
2497 | 2497 | | 2477with up-to-date information that provides information regarding utilization review requirements |
---|
2498 | 2498 | | 2478for treatments; (viii) the services that have no or low prior authorization denial rates across |
---|
2499 | 2499 | | 2479carriers; (ix) administrative barriers preventing active prior authorizations to continue for their |
---|
2500 | 2500 | | 2480approved duration in instances where an insured individual transitions to a new plan with the |
---|
2501 | 2501 | | 2481same carrier or to a new carrier; (x) expedited utilization review processes across carriers; and |
---|
2502 | 2502 | | 2482(xi) barriers to and solutions for providing uniformity in processes or requirements among |
---|
2503 | 2503 | | 2483different health care segments, including Medicaid, Medicare, fully-insured and self-insured |
---|
2504 | 2504 | | 2484commercial plans. |
---|
2505 | 2505 | | 2485 (c) The task force shall develop recommendations regarding: (i) simplifying and |
---|
2506 | 2506 | | 2486standardizing prior authorization for evidence-based treatments, services or courses of |
---|
2507 | 2507 | | 2487medication; (ii) improving access to medically necessary covered services for patients; (iii) |
---|
2508 | 2508 | | 2488reducing the response time from a carrier or utilization review organization for prior |
---|
2509 | 2509 | | 2489authorization approvals and denials; (iv) reducing administrative barriers and costs related to |
---|
2510 | 2510 | | 2490prior authorization on health care providers; (v) limiting the recoupment and denial of claims for |
---|
2511 | 2511 | | 2491medically necessary covered services; (vi) increasing transparency for covered benefits and prior |
---|
2512 | 2512 | | 2492authorization requirements; (vii) standardizing prior authorization processes, forms and |
---|
2513 | 2513 | | 2493requirements for use across health insurance carriers; (viii) eliminating prior authorization |
---|
2514 | 2514 | | 2494requirements for services, treatments, procedures and prescription drugs that have low variation |
---|
2515 | 2515 | | 2495in utilization across providers or low denial rates; (ix) eliminating prior authorization for or |
---|
2516 | 2516 | | 2496reducing the prior authorization review process to 24 hours for emergency treatments, services or |
---|
2517 | 2517 | | 2497courses of medication; (x) ensuring any physician or personnel under the supervision of a 116 of 119 |
---|
2518 | 2518 | | 2498physician that is reviewing a prior authorization request for a carrier has the clinical expertise to |
---|
2519 | 2519 | | 2499treat the medical condition or disease that is the subject of the request; and (xi) removing prior |
---|
2520 | 2520 | | 2500authorization for certain chronic disease management. |
---|
2521 | 2521 | | 2501 (d) The task force shall develop a report of its findings and recommendations, including |
---|
2522 | 2522 | | 2502any legislative or regulatory changes necessary to implement its recommendations. The task |
---|
2523 | 2523 | | 2503force shall file its report with the clerks of the senate and the house of representatives, the senate |
---|
2524 | 2524 | | 2504and house committees on ways and means and the joint committee on health care financing not |
---|
2525 | 2525 | | 2505later than July 31, 2025. |
---|
2526 | 2526 | | 2506 SECTION 112. Notwithstanding any general or special law to the contrary, the division |
---|
2527 | 2527 | | 2507of insurance shall consider the recommendations issued by the task force established in section |
---|
2528 | 2528 | | 2508111 in developing and implementing rules, regulations, bulletins or other guidance to simplify |
---|
2529 | 2529 | | 2509health insurance prior authorization standards and processes. |
---|
2530 | 2530 | | 2510 SECTION 113. (a) Notwithstanding any general or special law to the contrary, the |
---|
2531 | 2531 | | 2511secretary of health and human services shall direct monthly payments to eligible hospitals in the |
---|
2532 | 2532 | | 2512form of enhanced Medicaid payments, supplemental payments or other appropriate mechanisms. |
---|
2533 | 2533 | | 2513Each payment made to an eligible hospital shall be allocated in direct proportion to each eligible |
---|
2534 | 2534 | | 2514hospital’s average monthly Medicaid payments, as determined by the secretary, for inpatient and |
---|
2535 | 2535 | | 2515outpatient acute hospital services for the preceding year or the most recent year for which data is |
---|
2536 | 2536 | | 2516available; provided, however, that such enhanced Medicaid payments shall not be used in |
---|
2537 | 2537 | | 2517subsequent years by the secretary to calculate an eligible hospital’s average monthly payment; |
---|
2538 | 2538 | | 2518and provided further, that such payments shall not offset existing Medicaid payments for which |
---|
2539 | 2539 | | 2519an eligible hospital may be qualified to receive. In any fiscal year, the total sum of all payments 117 of 119 |
---|
2540 | 2540 | | 2520made to eligible hospitals under this section shall not exceed $45,000,000. Eligible hospitals may |
---|
2541 | 2541 | | 2521consider expending said payments to strengthen behavioral health supports and services. |
---|
2542 | 2542 | | 2522 (b) The secretary may require as a condition of receiving payment any such reasonable |
---|
2543 | 2543 | | 2523condition of payment that the secretary determines necessary to ensure the availability, to the |
---|
2544 | 2544 | | 2524extent possible, of federal financial participation for the payments and the secretary may incur |
---|
2545 | 2545 | | 2525expenses and the comptroller may certify amounts for payment in anticipation of expected |
---|
2546 | 2546 | | 2526receipt of federal financial participation for the payments. |
---|
2547 | 2547 | | 2527 (c) The executive office of health and human services may promulgate regulations as |
---|
2548 | 2548 | | 2528necessary to carry out this section. |
---|
2549 | 2549 | | 2529 (d) For the purposes of this section “eligible hospital” shall mean an acute care hospital |
---|
2550 | 2550 | | 2530licensed under section 51 of chapter 111 of the General Laws that: (i) has a statewide relative |
---|
2551 | 2551 | | 2531price less than 0.99, as calculated by the center for health information and analysis according to |
---|
2552 | 2552 | | 2532data from the most recent available year; (ii) has a public payer mix greater than 63 per cent, as |
---|
2553 | 2553 | | 2533calculated by the center for health information and analysis according to data from the most |
---|
2554 | 2554 | | 2534recent available year; and (iii) is not owned by or financially consolidated or corporately |
---|
2555 | 2555 | | 2535affiliated with a provider organization, as defined by section 1 of chapter 6D of the General |
---|
2556 | 2556 | | 2536Laws and as reported by the center for health information and analysis in the fiscal year 2022 |
---|
2557 | 2557 | | 2537hospital cost report database: (1) owns or controls 4 or more acute care hospitals licensed under |
---|
2558 | 2558 | | 2538said section 51 of said chapter 111; or (2) through which the total net assets of all affiliated acute |
---|
2559 | 2559 | | 2539care hospitals within the provider organization is greater than $800,000,000. 118 of 119 |
---|
2560 | 2560 | | 2540 (e) For the purposes of subsection (d), a clinical affiliation with a provider organization, |
---|
2561 | 2561 | | 2541absent ownership, financial consolidation or corporate affiliation, shall not disqualify an eligible |
---|
2562 | 2562 | | 2542hospital from payments authorized under this section. |
---|
2563 | 2563 | | 2543 SECTION 114. (a) Notwithstanding any general or special law to the contrary, for the |
---|
2564 | 2564 | | 2544purposes of monitoring and enforcing the health care cost growth benchmark for calendar years |
---|
2565 | 2565 | | 25452021 to 2025, inclusive, the center for health information and analysis shall apply sections 8, 9, |
---|
2566 | 2566 | | 254610, 16 and 18 of chapter 12C of the General Laws as those sections are in effect on December 1, |
---|
2567 | 2567 | | 25472024. |
---|
2568 | 2568 | | 2548 (b) Notwithstanding any general or special law to the contrary, for the purposes of |
---|
2569 | 2569 | | 2549monitoring and enforcing the health care cost growth benchmark for calendar years 2021 to |
---|
2570 | 2570 | | 25502025, inclusive, the health policy commission shall apply sections 9 and 10 of chapter 6D of the |
---|
2571 | 2571 | | 2551General Laws as those sections are in effect on December 1, 2024. |
---|
2572 | 2572 | | 2552 (c) Notwithstanding any general or special law to the contrary, the first benchmark cycle |
---|
2573 | 2573 | | 2553shall consist of the years 2025 and 2026. The health care cost growth benchmark for that |
---|
2574 | 2574 | | 2554benchmark cycle shall be the average of the 2025 health care cost growth benchmark that the |
---|
2575 | 2575 | | 2555health policy commission governing board established in 2024 and the growth rate of potential |
---|
2576 | 2576 | | 2556gross state product for 2026 established under section 7H½ of chapter 29 of the General Laws. |
---|
2577 | 2577 | | 2557 (d) Notwithstanding any general or special law to the contrary, not later than April 15, |
---|
2578 | 2578 | | 25582025, the board shall establish the health care cost growth benchmark pursuant to section 9 of |
---|
2579 | 2579 | | 2559chapter 6D of the general laws for: (i) the benchmark cycle consisting of the years 2025 and |
---|
2580 | 2580 | | 25602026; and (ii) the benchmark cycle consisting of the years 2026 and 2027. 119 of 119 |
---|
2581 | 2581 | | 2561 (e) Notwithstanding any general or special law to the contrary, on or before January 15, |
---|
2582 | 2582 | | 25622025, the secretary and house and senate committees on ways and means shall jointly develop |
---|
2583 | 2583 | | 2563growth rates of potential gross state product pursuant to section 7H½ of chapter 29 of the |
---|
2584 | 2584 | | 2564General Laws for each of the calendar years of 2026 and 2027. |
---|
2585 | 2585 | | 2565 SECTION 115. Notwithstanding any general or special law, rule or regulation to the |
---|
2586 | 2586 | | 2566contrary, section 13 of chapter 6D of the General Laws, as amended by this act, shall apply only |
---|
2587 | 2587 | | 2567to material change notices submitted after the effective date of this act; provided, however, that |
---|
2588 | 2588 | | 2568said section 13 of said chapter 6D shall apply to material changes that meet all of the following |
---|
2589 | 2589 | | 2569criteria: (i) the health policy commission received a completed material change notice regarding |
---|
2590 | 2590 | | 2570the material change on or after March 1, 2024; (ii) the health policy commission has not yet |
---|
2591 | 2591 | | 2571determined whether to conduct a cost and market impact review in regard to the material change; |
---|
2592 | 2592 | | 2572and (iii) the health policy commission classifies the material change as involving a provider or |
---|
2593 | 2593 | | 2573provider organization’s merger or affiliation resulting in an increase in net patient service |
---|
2594 | 2594 | | 2574revenue of $10,000,000 or more. For such material change notices, the health policy commission |
---|
2595 | 2595 | | 2575shall be permitted to require submission of a new or revised material change form, request |
---|
2596 | 2596 | | 2576additional documentation and information and take an additional 30 days to conduct its |
---|
2597 | 2597 | | 2577preliminary review. |
---|
2598 | 2598 | | 2578 SECTION 116. Notwithstanding any general or special law, rule or regulation to the |
---|
2599 | 2599 | | 2579contrary, the health policy commission shall submit the first state health plan to the governor and |
---|
2600 | 2600 | | 2580the general court, as required under section 22 of chapter 6D of the General Laws, on or before |
---|
2601 | 2601 | | 2581January 1, 2026. 120 of 119 |
---|
2602 | 2602 | | 2582 SECTION 117. Notwithstanding any general or special law to the contrary, section 23 of |
---|
2603 | 2603 | | 2583said chapter 6D shall only apply to private equity firms that obtain a financial interest in a |
---|
2604 | 2604 | | 2584provider or provider organization and to financial actions taken by registered provider |
---|
2605 | 2605 | | 2585organizations with private equity investment after the effective date of this act. |
---|
2606 | 2606 | | 2586 SECTION 118. Notwithstanding any general or special law, rule or regulation to the |
---|
2607 | 2607 | | 2587contrary, section 4B of chapter 112 of the General Laws shall apply only to contracts or |
---|
2608 | 2608 | | 2588agreements between medical practices and management services organizations entered into after |
---|
2609 | 2609 | | 2589the effective date of this act. |
---|
2610 | 2610 | | 2590 SECTION 119. Section 17 shall take effect on January 1, 2025. |
---|
2611 | 2611 | | 2591 SECTION 120. Section 67 shall take effect on August 1, 2025. |
---|
2612 | 2612 | | 2592 SECTION 121. All health care practices required to register pursuant to section 4A of |
---|
2613 | 2613 | | 2593chapter 112 of the General Laws shall register with the board of registration in medicine not later |
---|
2614 | 2614 | | 2594than January 1, 2026. |
---|
2615 | 2615 | | 2595 SECTION 122. The commissioner of occupational licensure and the commissioner of |
---|
2616 | 2616 | | 2596public health shall adopt the regulations required under section 96 not later than 6 months after |
---|
2617 | 2617 | | 2597the effective date of this act. |
---|
2618 | 2618 | | 2598 SECTION 123. The division of insurance shall adopt the rules and regulations required |
---|
2619 | 2619 | | 2599under section Error! Reference source not found.112 not later than 6 months after the task force |
---|
2620 | 2620 | | 2600established in section 111 issues its final report and recommendations. |
---|
2621 | 2621 | | 2601 SECTION 124. Section 113 is hereby repealed. |
---|
2622 | 2622 | | 2602 SECTION 125. Section 124 shall take effect 2 years from the effective date of this act. |
---|