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2 | 2 | | HOUSE DOCKET, NO. 2413 FILED ON: 1/19/2023 |
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3 | 3 | | HOUSE . . . . . . . . . . . . . . . No. 1074 |
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4 | 4 | | The Commonwealth of Massachusetts |
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5 | 5 | | _________________ |
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6 | 6 | | PRESENTED BY: |
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7 | 7 | | Meghan Kilcoyne |
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8 | 8 | | _________________ |
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9 | 9 | | To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General |
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10 | 10 | | Court assembled: |
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11 | 11 | | The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill: |
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12 | 12 | | An Act relative to cancer patient access to biomarker testing to provide appropriate therapy. |
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13 | 13 | | _______________ |
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14 | 14 | | PETITION OF: |
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15 | 15 | | NAME:DISTRICT/ADDRESS :DATE ADDED:Meghan Kilcoyne12th Worcester1/18/2023Lindsay N. Sabadosa1st Hampshire2/3/2023Paul J. Donato35th Middlesex2/3/2023Jack Patrick Lewis7th Middlesex2/3/2023Michael P. Kushmerek3rd Worcester2/3/2023Joseph W. McGonagle, Jr.28th Middlesex2/3/2023Kelly W. Pease4th Hampden2/3/2023Patricia A. Duffy5th Hampden2/3/2023Hannah Kane11th Worcester2/3/2023James C. Arena-DeRosa8th Middlesex2/21/2023Sean Garballey23rd Middlesex2/21/2023Daniel Cahill10th Essex2/21/2023Jessica Ann Giannino16th Suffolk2/21/2023William J. Driscoll, Jr.7th Norfolk2/21/2023Jon Santiago9th Suffolk2/21/2023Josh S. Cutler6th Plymouth2/21/2023John J. CroninWorcester and Middlesex2/21/2023Jason M. LewisFifth Middlesex2/21/2023 2 of 2 |
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16 | 16 | | Danielle W. Gregoire4th Middlesex2/21/2023Daniel M. Donahue16th Worcester2/21/2023Adrian C. Madaro1st Suffolk2/21/2023Patrick M. O'ConnorFirst Plymouth and Norfolk2/21/2023Walter F. TimiltyNorfolk, Plymouth and Bristol2/21/2023Michael D. BradySecond Plymouth and Norfolk2/21/2023Thomas M. Stanley9th Middlesex2/21/2023Carole A. Fiola6th Bristol2/21/2023Patrick Joseph Kearney4th Plymouth2/21/2023David M. Rogers24th Middlesex2/21/2023Carmine Lawrence Gentile13th Middlesex2/21/2023Christine P. Barber34th Middlesex2/21/2023Michelle M. DuBois10th Plymouth2/21/2023Edward R. Philips8th Norfolk2/21/2023Aaron L. Saunders7th Hampden2/21/2023Rob Consalvo14th Suffolk2/21/2023Denise C. Garlick13th Norfolk2/21/2023James Arciero2nd Middlesex2/21/2023David Biele4th Suffolk3/1/2023Jonathan D. Zlotnik2nd Worcester3/1/2023Bruce J. Ayers1st Norfolk3/13/2023 1 of 14 |
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17 | 17 | | HOUSE DOCKET, NO. 2413 FILED ON: 1/19/2023 |
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18 | 18 | | HOUSE . . . . . . . . . . . . . . . No. 1074 |
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19 | 19 | | By Representative Kilcoyne of Clinton, a petition (accompanied by bill, House, No. 1074) of |
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20 | 20 | | Meghan Kilcoyne and others relative to cancer patient access to biomarker testing to provide |
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21 | 21 | | appropriate therapy. Financial Services. |
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22 | 22 | | The Commonwealth of Massachusetts |
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23 | 23 | | _______________ |
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24 | 24 | | In the One Hundred and Ninety-Third General Court |
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25 | 25 | | (2023-2024) |
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26 | 26 | | _______________ |
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27 | 27 | | An Act relative to cancer patient access to biomarker testing to provide appropriate therapy. |
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28 | 28 | | Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority |
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29 | 29 | | of the same, as follows: |
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30 | 30 | | 1 SECTION 1. Chapter 32A of the General Laws is hereby amended by inserting after |
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31 | 31 | | 2section 17R, the following section:- |
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32 | 32 | | 3 Section 17S. (a) As used in this section, the following words shall have the following |
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33 | 33 | | 4meanings: |
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34 | 34 | | 5 “Biomarker” means a characteristic that is objectively measured and evaluated as an |
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35 | 35 | | 6indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a |
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36 | 36 | | 7specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or |
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37 | 37 | | 8protein expression. |
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38 | 38 | | 9 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for |
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39 | 39 | | 10the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests, |
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40 | 40 | | 11multi-plex panel tests, and whole genome sequencing. 2 of 14 |
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41 | 41 | | 12 “Consensus statements” as used here are statements developed by an independent, |
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42 | 42 | | 13multidisciplinary panel of experts utilizing a transparent methodology and reporting structure |
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43 | 43 | | 14and with a conflict of interest policy. These statements are aimed at specific clinical |
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44 | 44 | | 15circumstances and base the statements on the best available evidence for the purpose of |
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45 | 45 | | 16optimizing the outcomes of clinical care. |
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46 | 46 | | 17 “Nationally recognized clinical practice guidelines” as used here are evidence-based |
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47 | 47 | | 18clinical practice guidelines developed by independent organizations or medical professional |
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48 | 48 | | 19societies utilizing a transparent methodology and reporting structure and with a conflict of |
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49 | 49 | | 20interest policy. Clinical practice guidelines establish standards of care informed by a systematic |
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50 | 50 | | 21review of evidence and an assessment of the benefits and costs of alternative care options and |
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51 | 51 | | 22include recommendations intended to optimize patient care. |
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52 | 52 | | 23 (b) The commission shall provide to any active or retired employee of the commonwealth |
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53 | 53 | | 24who is insured under the group insurance commission coverage for biomarker testing as defined |
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54 | 54 | | 25in this section, pursuant to criteria established under subsection (c). |
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55 | 55 | | 26 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment, |
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56 | 56 | | 27appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the |
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57 | 57 | | 28test is supported by medical and scientific evidence, including, but not limited to: |
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58 | 58 | | 29 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an |
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59 | 59 | | 30FDA-approved drug; |
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60 | 60 | | 31 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage |
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61 | 61 | | 32Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations; |
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62 | 62 | | 33or 3 of 14 |
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63 | 63 | | 34 (3) Nationally recognized clinical practice guidelines and consensus statements. |
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64 | 64 | | 35 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that |
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65 | 65 | | 36limits disruptions in care including the need for multiple biopsies or biospecimen samples. |
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66 | 66 | | 37 (e) In the case of coverage which requires prior authorization, a carrier or a utilization |
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67 | 67 | | 38review organization subject to this section must approve or deny a prior authorization request or |
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68 | 68 | | 39appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If |
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69 | 69 | | 40additional delay would result in significant risk to the insured’s health or well-being, a carrier or |
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70 | 70 | | 41a utilization review organization shall approve or deny the request within 24 hours. If a response |
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71 | 71 | | 42by a carrier or utilization review organization is not received within the time required under this |
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72 | 72 | | 43paragraph, said request or appeal shall be deemed granted. |
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73 | 73 | | 44 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible, |
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74 | 74 | | 45and convenient processes to request an exception to a coverage policy or an adverse utilization |
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75 | 75 | | 46review determination. The process shall be made readily accessible on the carrier’s website. |
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76 | 76 | | 47 SECTION 2. Chapter 118E of the General Laws is hereby amended by inserting after |
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77 | 77 | | 48section 10N, the following section:- |
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78 | 78 | | 49 Section 10O. (a) As used in this section, the following words shall have the following |
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79 | 79 | | 50meanings: |
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80 | 80 | | 51 “Biomarker” means a characteristic that is objectively measured and evaluated as an |
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81 | 81 | | 52indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a |
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82 | 82 | | 53specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or |
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83 | 83 | | 54protein expression. 4 of 14 |
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84 | 84 | | 55 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for |
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85 | 85 | | 56the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests, |
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86 | 86 | | 57multi-plex panel tests, and whole genome sequencing. |
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87 | 87 | | 58 “Consensus statements” as used here are statements developed by an independent, |
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88 | 88 | | 59multidisciplinary panel of experts utilizing a transparent methodology and reporting structure |
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89 | 89 | | 60and with a conflict of interest policy. These statements are aimed at specific clinical |
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90 | 90 | | 61circumstances and base the statements on the best available evidence for the purpose of |
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91 | 91 | | 62optimizing the outcomes of clinical care. |
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92 | 92 | | 63 “Nationally recognized clinical practice guidelines” as used here are evidence-based |
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93 | 93 | | 64clinical practice guidelines developed by independent organizations or medical professional |
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94 | 94 | | 65societies utilizing a transparent methodology and reporting structure and with a conflict of |
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95 | 95 | | 66interest policy. Clinical practice guidelines establish standards of care informed by a systematic |
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96 | 96 | | 67review of evidence and an assessment of the benefits and costs of alternative care options and |
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97 | 97 | | 68include recommendations intended to optimize patient care. |
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98 | 98 | | 69 (b) The division and its contracted health insurers, health plans, health maintenance |
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99 | 99 | | 70organizations, behavioral health management firms and third-party administrators under contract |
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100 | 100 | | 71to a Medicaid managed care organization or primary care clinician plan shall provide coverage |
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101 | 101 | | 72for biomarker testing as defined in this section, pursuant to criteria established under subsection |
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102 | 102 | | 73(c). |
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103 | 103 | | 74 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment, |
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104 | 104 | | 75appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the |
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105 | 105 | | 76test is supported by medical and scientific evidence, including, but not limited to: 5 of 14 |
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106 | 106 | | 77 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an |
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107 | 107 | | 78FDA-approved drug; |
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108 | 108 | | 79 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage |
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109 | 109 | | 80Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations; |
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110 | 110 | | 81or |
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111 | 111 | | 82 (3) Nationally recognized clinical practice guidelines and consensus statements. |
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112 | 112 | | 83 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that |
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113 | 113 | | 84limits disruptions in care including the need for multiple biopsies or biospecimen samples. |
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114 | 114 | | 85 (e) In the case of coverage which requires prior authorization, a carrier or a utilization |
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115 | 115 | | 86review organization subject to this section must approve or deny a prior authorization request or |
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116 | 116 | | 87appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If |
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117 | 117 | | 88additional delay would result in significant risk to the insured’s health or well-being, a carrier or |
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118 | 118 | | 89a utilization review organization shall approve or deny the request within 24 hours. If a response |
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119 | 119 | | 90by a carrier or utilization review organization is not received within the time required under this |
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120 | 120 | | 91paragraph, said request or appeal shall be deemed granted. |
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121 | 121 | | 92 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible, |
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122 | 122 | | 93and convenient processes to request an exception to a coverage policy or an adverse utilization |
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123 | 123 | | 94review determination. The process shall be made readily accessible on the carrier’s website. |
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124 | 124 | | 95 SECTION 3. Chapter 175 of the General Laws is hereby amended by inserting after |
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125 | 125 | | 96section 47PP, the following section:- 6 of 14 |
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126 | 126 | | 97 Section 47QQ. (a) As used in this section, the following words shall have the following |
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127 | 127 | | 98meanings: |
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128 | 128 | | 99 “Biomarker” means a characteristic that is objectively measured and evaluated as an |
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129 | 129 | | 100indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a |
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130 | 130 | | 101specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or |
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131 | 131 | | 102protein expression. |
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132 | 132 | | 103 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for |
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133 | 133 | | 104the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests, |
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134 | 134 | | 105multi-plex panel tests, and whole genome sequencing. |
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135 | 135 | | 106 “Consensus statements” as used here are statements developed by an independent, |
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136 | 136 | | 107multidisciplinary panel of experts utilizing a transparent methodology and reporting structure |
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137 | 137 | | 108and with a conflict of interest policy. These statements are aimed at specific clinical |
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138 | 138 | | 109circumstances and base the statements on the best available evidence for the purpose of |
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139 | 139 | | 110optimizing the outcomes of clinical care. |
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140 | 140 | | 111 “Nationally recognized clinical practice guidelines” as used here are evidence-based |
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141 | 141 | | 112clinical practice guidelines developed by independent organizations or medical professional |
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142 | 142 | | 113societies utilizing a transparent methodology and reporting structure and with a conflict of |
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143 | 143 | | 114interest policy. Clinical practice guidelines establish standards of care informed by a systematic |
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144 | 144 | | 115review of evidence and an assessment of the benefits and costs of alternative care options and |
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145 | 145 | | 116include recommendations intended to optimize patient care. |
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146 | 146 | | 117 (b) An individual policy of accident and sickness insurance issued under section 108 that |
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147 | 147 | | 118provides benefits for hospital expenses and surgical expenses and any group blanket policy of 7 of 14 |
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148 | 148 | | 119accident and sickness insurance issued under section 110 that provides benefits for hospital |
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149 | 149 | | 120expenses and surgical expenses delivered, issued or renewed by agreement between the insurer |
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150 | 150 | | 121and the policyholder, within or outside the commonwealth, shall provide benefits for residents of |
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151 | 151 | | 122the commonwealth and all group members having a principal place of employment in the |
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152 | 152 | | 123commonwealth for biomarker testing as defined in this section, pursuant to criteria established |
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153 | 153 | | 124under subsection (c). |
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154 | 154 | | 125 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment, |
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155 | 155 | | 126appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the |
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156 | 156 | | 127test is supported by medical and scientific evidence, including, but not limited to: |
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157 | 157 | | 128 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an |
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158 | 158 | | 129FDA-approved drug; |
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159 | 159 | | 130 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage |
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160 | 160 | | 131Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations; |
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161 | 161 | | 132or |
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162 | 162 | | 133 (3) Nationally recognized clinical practice guidelines and consensus statements. |
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163 | 163 | | 134 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that |
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164 | 164 | | 135limits disruptions in care including the need for multiple biopsies or biospecimen samples. |
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165 | 165 | | 136 (e) In the case of coverage which requires prior authorization, a carrier or a utilization |
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166 | 166 | | 137review organization subject to this section must approve or deny a prior authorization request or |
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167 | 167 | | 138appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If |
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168 | 168 | | 139additional delay would result in significant risk to the insured’s health or well-being, a carrier or 8 of 14 |
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169 | 169 | | 140a utilization review organization shall approve or deny the request within 24 hours. If a response |
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170 | 170 | | 141by a carrier or utilization review organization is not received within the time required under this |
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171 | 171 | | 142paragraph, said request or appeal shall be deemed granted. |
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172 | 172 | | 143 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible, |
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173 | 173 | | 144and convenient processes to request an exception to a coverage policy or an adverse utilization |
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174 | 174 | | 145review determination. The process shall be made readily accessible on the carrier’s website. |
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175 | 175 | | 146 SECTION 4. Chapter 176A of the General Laws is hereby amended by inserting after |
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176 | 176 | | 147section 8QQ, the following section:- |
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177 | 177 | | 148 Section 8RR. (a) As used in this section, the following words shall have the following |
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178 | 178 | | 149meanings: |
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179 | 179 | | 150 “Biomarker” means a characteristic that is objectively measured and evaluated as an |
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180 | 180 | | 151indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a |
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181 | 181 | | 152specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or |
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182 | 182 | | 153protein expression. |
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183 | 183 | | 154 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for |
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184 | 184 | | 155the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests, |
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185 | 185 | | 156multi-plex panel tests, and whole genome sequencing. |
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186 | 186 | | 157 “Consensus statements” as used here are statements developed by an independent, |
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187 | 187 | | 158multidisciplinary panel of experts utilizing a transparent methodology and reporting structure |
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188 | 188 | | 159and with a conflict of interest policy. These statements are aimed at specific clinical 9 of 14 |
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189 | 189 | | 160circumstances and base the statements on the best available evidence for the purpose of |
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190 | 190 | | 161optimizing the outcomes of clinical care. |
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191 | 191 | | 162 “Nationally recognized clinical practice guidelines” as used here are evidence-based |
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192 | 192 | | 163clinical practice guidelines developed by independent organizations or medical professional |
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193 | 193 | | 164societies utilizing a transparent methodology and reporting structure and with a conflict of |
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194 | 194 | | 165interest policy. Clinical practice guidelines establish standards of care informed by a systematic |
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195 | 195 | | 166review of evidence and an assessment of the benefits and costs of alternative care options and |
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196 | 196 | | 167include recommendations intended to optimize patient care. |
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197 | 197 | | 168 (b) Any contract between a subscriber and the corporation under an individual or group |
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198 | 198 | | 169hospital service plan that is delivered, issued or renewed within the commonwealth shall provide |
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199 | 199 | | 170coverage for biomarker testing as defined in this section, pursuant to criteria established under |
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200 | 200 | | 171subsection (c). |
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201 | 201 | | 172 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment, |
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202 | 202 | | 173appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the |
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203 | 203 | | 174test is supported by medical and scientific evidence, including, but not limited to: |
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204 | 204 | | 175 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an |
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205 | 205 | | 176FDA-approved drug; |
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206 | 206 | | 177 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage |
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207 | 207 | | 178Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations; |
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208 | 208 | | 179or |
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209 | 209 | | 180 (3) Nationally recognized clinical practice guidelines and consensus statements. 10 of 14 |
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210 | 210 | | 181 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that |
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211 | 211 | | 182limits disruptions in care including the need for multiple biopsies or biospecimen samples. |
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212 | 212 | | 183 (e) In the case of coverage which requires prior authorization, a carrier or a utilization |
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213 | 213 | | 184review organization subject to this section must approve or deny a prior authorization request or |
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214 | 214 | | 185appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If |
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215 | 215 | | 186additional delay would result in significant risk to the insured’s health or well-being, a carrier or |
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216 | 216 | | 187a utilization review organization shall approve or deny the request within 24 hours. If a response |
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217 | 217 | | 188by a carrier or utilization review organization is not received within the time required under this |
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218 | 218 | | 189paragraph, said request or appeal shall be deemed granted. |
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219 | 219 | | 190 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible, |
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220 | 220 | | 191and convenient processes to request an exception to a coverage policy or an adverse utilization |
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221 | 221 | | 192review determination. The process shall be made readily accessible on the carrier’s website. |
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222 | 222 | | 193 SECTION 5. Chapter 176B of the General Laws is hereby amended by inserting after |
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223 | 223 | | 194section 4QQ, the following section:- |
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224 | 224 | | 195 Section 4RR. (a) As used in this section, the following words shall have the following |
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225 | 225 | | 196meanings: |
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226 | 226 | | 197 “Biomarker” means a characteristic that is objectively measured and evaluated as an |
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227 | 227 | | 198indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a |
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228 | 228 | | 199specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or |
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229 | 229 | | 200protein expression. 11 of 14 |
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230 | 230 | | 201 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for |
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231 | 231 | | 202the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests, |
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232 | 232 | | 203multi-plex panel tests, and whole genome sequencing. |
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233 | 233 | | 204 “Consensus statements” as used here are statements developed by an independent, |
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234 | 234 | | 205multidisciplinary panel of experts utilizing a transparent methodology and reporting structure |
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235 | 235 | | 206and with a conflict of interest policy. These statements are aimed at specific clinical |
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236 | 236 | | 207circumstances and base the statements on the best available evidence for the purpose of |
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237 | 237 | | 208optimizing the outcomes of clinical care. |
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238 | 238 | | 209 “Nationally recognized clinical practice guidelines” as used here are evidence-based |
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239 | 239 | | 210clinical practice guidelines developed by independent organizations or medical professional |
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240 | 240 | | 211societies utilizing a transparent methodology and reporting structure and with a conflict of |
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241 | 241 | | 212interest policy. Clinical practice guidelines establish standards of care informed by a systematic |
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242 | 242 | | 213review of evidence and an assessment of the benefits and costs of alternative care options and |
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243 | 243 | | 214include recommendations intended to optimize patient care. |
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244 | 244 | | 215 (b) Any subscription certificate under an individual or group medical service agreement |
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245 | 245 | | 216delivered, issued or renewed within the commonwealth shall provide coverage for biomarker |
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246 | 246 | | 217testing as defined in this section, pursuant to criteria established under subsection (c). |
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247 | 247 | | 218 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment, |
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248 | 248 | | 219appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the |
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249 | 249 | | 220test is supported by medical and scientific evidence, including, but not limited to: |
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250 | 250 | | 221 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an |
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251 | 251 | | 222FDA-approved drug; 12 of 14 |
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252 | 252 | | 223 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage |
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253 | 253 | | 224Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations; |
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254 | 254 | | 225or |
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255 | 255 | | 226 (3) Nationally recognized clinical practice guidelines and consensus statements. |
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256 | 256 | | 227 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that |
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257 | 257 | | 228limits disruptions in care including the need for multiple biopsies or biospecimen samples. |
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258 | 258 | | 229 (e) In the case of coverage which requires prior authorization, a carrier or a utilization |
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259 | 259 | | 230review organization subject to this section must approve or deny a prior authorization request or |
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260 | 260 | | 231appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If |
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261 | 261 | | 232additional delay would result in significant risk to the insured’s health or well-being, a carrier or |
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262 | 262 | | 233a utilization review organization shall approve or deny the request within 24 hours. If a response |
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263 | 263 | | 234by a carrier or utilization review organization is not received within the time required under this |
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264 | 264 | | 235paragraph, said request or appeal shall be deemed granted. |
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265 | 265 | | 236 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible, |
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266 | 266 | | 237and convenient processes to request an exception to a coverage policy or an adverse utilization |
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267 | 267 | | 238review determination. The process shall be made readily accessible on the carrier’s website. |
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268 | 268 | | 239 SECTION 6. Chapter 176G of the General Laws is hereby amended by inserting after |
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269 | 269 | | 240section 4GG, as so appearing, the following section:- |
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270 | 270 | | 241 Section 4JJ. (a) As used in this section, the following words shall have the following |
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271 | 271 | | 242meanings: 13 of 14 |
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272 | 272 | | 243 “Biomarker” means a characteristic that is objectively measured and evaluated as an |
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273 | 273 | | 244indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a |
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274 | 274 | | 245specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or |
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275 | 275 | | 246protein expression. |
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276 | 276 | | 247 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for |
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277 | 277 | | 248the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests, |
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278 | 278 | | 249multi-plex panel tests, and whole genome sequencing. |
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279 | 279 | | 250 “Consensus statements” as used here are statements developed by an independent, |
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280 | 280 | | 251multidisciplinary panel of experts utilizing a transparent methodology and reporting structure |
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281 | 281 | | 252and with a conflict of interest policy. These statements are aimed at specific clinical |
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282 | 282 | | 253circumstances and base the statements on the best available evidence for the purpose of |
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283 | 283 | | 254optimizing the outcomes of clinical care. |
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284 | 284 | | 255 “Nationally recognized clinical practice guidelines” as used here are evidence-based |
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285 | 285 | | 256clinical practice guidelines developed by independent organizations or medical professional |
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286 | 286 | | 257societies utilizing a transparent methodology and reporting structure and with a conflict of |
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287 | 287 | | 258interest policy. Clinical practice guidelines establish standards of care informed by a systematic |
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288 | 288 | | 259review of evidence and an assessment of the benefits and costs of alternative care options and |
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289 | 289 | | 260include recommendations intended to optimize patient care. |
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290 | 290 | | 261 (b) Any individual or group health maintenance contract that is issued or renewed within |
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291 | 291 | | 262or without the commonwealth shall provide coverage for biomarker testing as defined in this |
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292 | 292 | | 263section, pursuant to criteria established under subsection (c). 14 of 14 |
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293 | 293 | | 264 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment, |
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294 | 294 | | 265appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the |
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295 | 295 | | 266test is supported by medical and scientific evidence, including, but not limited to: |
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296 | 296 | | 267 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an |
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297 | 297 | | 268FDA-approved drug; |
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298 | 298 | | 269 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage |
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299 | 299 | | 270Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations; |
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300 | 300 | | 271or |
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301 | 301 | | 272 (3) Nationally recognized clinical practice guidelines and consensus statements. |
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302 | 302 | | 273 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that |
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303 | 303 | | 274limits disruptions in care including the need for multiple biopsies or biospecimen samples. |
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304 | 304 | | 275 (e) In the case of coverage which requires prior authorization, a carrier or a utilization |
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305 | 305 | | 276review organization subject to this section must approve or deny a prior authorization request or |
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306 | 306 | | 277appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If |
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307 | 307 | | 278additional delay would result in significant risk to the insured’s health or well-being, a carrier or |
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308 | 308 | | 279a utilization review organization shall approve or deny the request within 24 hours. If a response |
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309 | 309 | | 280by a carrier or utilization review organization is not received within the time required under this |
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310 | 310 | | 281paragraph, said request or appeal shall be deemed granted. |
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311 | 311 | | 282 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible, |
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312 | 312 | | 283and convenient processes to request an exception to a coverage policy or an adverse utilization |
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313 | 313 | | 284review determination. The process shall be made readily accessible on the carrier’s website. |
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