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2 | 2 | | HOUSE DOCKET, NO. 2117 FILED ON: 1/15/2025 |
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3 | 3 | | HOUSE . . . . . . . . . . . . . . . No. 1358 |
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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 | | Marjorie C. Decker |
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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 advancing health care research and decision-making centered on patients and people with |
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13 | 13 | | disabilities. |
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14 | 14 | | _______________ |
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15 | 15 | | PETITION OF: |
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16 | 16 | | NAME:DISTRICT/ADDRESS :DATE ADDED:Marjorie C. Decker25th Middlesex1/15/2025 1 of 4 |
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17 | 17 | | HOUSE DOCKET, NO. 2117 FILED ON: 1/15/2025 |
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18 | 18 | | HOUSE . . . . . . . . . . . . . . . No. 1358 |
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19 | 19 | | By Representative Decker of Cambridge, a petition (accompanied by bill, House, No. 1358) of |
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20 | 20 | | Marjorie C. Decker relative to health care research and decision-making centered on patients and |
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21 | 21 | | persons with disabilities. Health Care Financing. |
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22 | 22 | | The Commonwealth of Massachusetts |
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23 | 23 | | _______________ |
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24 | 24 | | In the One Hundred and Ninety-Fourth General Court |
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25 | 25 | | (2025-2026) |
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26 | 26 | | _______________ |
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27 | 27 | | An Act advancing health care research and decision-making centered on patients and people with |
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28 | 28 | | disabilities. |
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29 | 29 | | Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority |
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30 | 30 | | of the same, as follows: |
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31 | 31 | | 1 SECTION 1. Chapter 118E of the General Laws is hereby amended by adding the |
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32 | 32 | | 2following section: |
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33 | 33 | | 3 Section 80: Patient-Centeredness |
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34 | 34 | | 4 Section 80 (a) Standards for Patient-Centeredness in Research & Analysis. The Division |
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35 | 35 | | 5of Medical Assistance shall ensure that any portfolio of research and analysis relied upon for |
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36 | 36 | | 6decision-making, whether provided by a state agency or a third party, impacting enrollee access |
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37 | 37 | | 7to healthcare treatments and services, meets standards of patient-centeredness. The Division of |
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38 | 38 | | 8Medical Assistance shall publicly provide a summary of patient-centeredness standards for any |
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39 | 39 | | 9such analysis that includes, but is not limited to: |
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40 | 40 | | 10 1) Evaluation of a range of research and analysis that includes outcomes prioritized by |
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41 | 41 | | 11patients and people with disabilities within a specific disease area. If necessary, the Division of 2 of 4 |
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42 | 42 | | 12Medical Assistance will commission a survey of patients to identify relevant outcomes within a |
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43 | 43 | | 13disease area. |
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44 | 44 | | 14 2) Evaluation of a range of research and analysis that looks at relevant patient subgroups |
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45 | 45 | | 15to ensure consideration of important differences in preferences and clinical characteristics within |
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46 | 46 | | 16patient subpopulations. |
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47 | 47 | | 17 3) Scientific Rigor: The Division of Medical Assistance shall require research and |
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48 | 48 | | 18analysis to comply with good research practices, defined as consideration of the full range of |
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49 | 49 | | 19relevant, peer-reviewed evidence (e.g., real-world evidence, research from range of sponsors |
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50 | 50 | | 20including manufacturers), avoid patient harm through over-interpretation of findings of |
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51 | 51 | | 21“inconclusive” evidence of clinical differences and instead allow time for conduct of additional |
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52 | 52 | | 22research. |
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53 | 53 | | 23 (b) Prohibition on Reliance on Discriminatory Measures. The Division of Medical |
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54 | 54 | | 24Assistance shall not develop or utilize, directly or indirectly through a contracted entity or other |
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55 | 55 | | 25third-party, a dollars-per-quality adjusted life year or any similar measures or research in |
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56 | 56 | | 26determining whether a particular health care treatment is cost effective, recommended, the value |
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57 | 57 | | 27of a treatment, or in determining coverage, reimbursement, appropriate payment amounts, cost- |
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58 | 58 | | 28sharing, or incentive policies or programs. |
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59 | 59 | | 29 (c) Appeals and Physician Override Mechanisms. The Division of Medical Assistance |
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60 | 60 | | 30may not implement any policy limiting patient access to healthcare treatment and services which |
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61 | 61 | | 31does not contain an appeals or physician override mechanism. Physicians may not be |
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62 | 62 | | 32discriminated against or otherwise negatively impacted for utilizing available physician override |
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63 | 63 | | 33mechanisms. 3 of 4 |
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64 | 64 | | 34 SECTION 2. Chapter 6D of the General Laws is hereby amended by adding the |
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65 | 65 | | 35following section: |
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66 | 66 | | 36 Section 20. Patient-Centeredness Standards for Health Policy Commission Reviews |
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67 | 67 | | 37 Section 20 (a) Standards for Patient-Centeredness in Research & Analysis. The Health |
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68 | 68 | | 38Policy Commission shall ensure that any portfolio of research and analysis relied upon for |
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69 | 69 | | 39determining the value of a healthcare treatment or service , whether provided by a state agency |
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70 | 70 | | 40or a third party, impacting enrollee access to healthcare treatments and services, meets standards |
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71 | 71 | | 41of patient-centeredness. The Health Policy Commission shall publicly provide a summary of |
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72 | 72 | | 42patient-centeredness standards for any such analysis that includes, but is not limited to: |
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73 | 73 | | 43 1) Evaluation of a range of research and analysis that includes outcomes prioritized by |
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74 | 74 | | 44patients and people with disabilities within a specific disease area. If necessary, the Health Policy |
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75 | 75 | | 45Commission will commission a survey of patients to identify relevant outcomes within a disease |
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76 | 76 | | 46area. |
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77 | 77 | | 47 2) Evaluation of a range of research and analysis that looks at relevant patient subgroups |
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78 | 78 | | 48to ensure consideration of important differences in preferences and clinical characteristics within |
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79 | 79 | | 49patient subpopulations. |
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80 | 80 | | 50 3) Scientific Rigor: The Health Policy Commission shall require research and analysis to |
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81 | 81 | | 51comply with good research practices, defined as consideration of the full range of relevant, peer- |
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82 | 82 | | 52reviewed evidence (e.g., real-world evidence, research from range of sponsors including |
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83 | 83 | | 53manufacturers), avoid patient harm through over-interpretation of findings of “inconclusive” |
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84 | 84 | | 54evidence of clinical differences and instead allow time for conduct of additional research. 4 of 4 |
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85 | 85 | | 55 (b) Prohibition on Reliance on Discriminatory Measures. The Health Policy Commission |
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86 | 86 | | 56shall not develop or utilize, directly or indirectly through a contracted entity or other third-party, |
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87 | 87 | | 57a dollars-per-quality adjusted life year or any similar measures or research in determining |
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88 | 88 | | 58whether a particular health care treatment is cost effective, recommended, the value of a |
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89 | 89 | | 59treatment, or in determining coverage, reimbursement, appropriate payment amounts, cost- |
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90 | 90 | | 60sharing, or incentive policies or programs. |
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