1 of 1 SENATE DOCKET, NO. 2117 FILED ON: 1/20/2023 SENATE . . . . . . . . . . . . . . No. 730 The Commonwealth of Massachusetts _________________ PRESENTED BY: Brendan P. Crighton _________________ To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General Court assembled: The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill: An Act advancing health care research and decision-making centered on patients and people with disabilities. _______________ PETITION OF: NAME:DISTRICT/ADDRESS :Brendan P. CrightonThird Essex 1 of 4 SENATE DOCKET, NO. 2117 FILED ON: 1/20/2023 SENATE . . . . . . . . . . . . . . No. 730 By Mr. Crighton, a petition (accompanied by bill, Senate, No. 730) of Brendan P. Crighton for legislation to advance health care research and decision-making centered on patients and people with disabilities. Health Care Financing. [SIMILAR MATTER FILED IN PREVIOUS SESSION SEE SENATE, NO. 753 OF 2021-2022.] The Commonwealth of Massachusetts _______________ In the One Hundred and Ninety-Third General Court (2023-2024) _______________ An Act advancing health care research and decision-making centered on patients and people with disabilities. Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows: 1 SECTION 1. Chapter 118E: DIVISION OF MEDICAL ASSISTANCE of the 2Massachusetts General Laws, as appearing in the 2018 Official Edition, is hereby amended by 3adding the following section: 4 Section 79: Patient-Centeredness 5 Section 79 (a) Standards for Patient-Centeredness in Research & Analysis. The Division 6of Medical Assistance shall ensure that any portfolio of research and analysis relied upon for 7decision-making, whether provided by a state agency or a third party, impacting enrollee access 8to healthcare treatments and services, meets standards of patient-centeredness. The Division of 2 of 4 9Medical Assistance shall publicly provide a summary of patient-centeredness standards for any 10such analysis that includes, but is not limited to: 11 1) Evaluation of a range of research and analysis that includes outcomes prioritized by 12patients and people with disabilities within a specific disease area. If necessary, the Division of 13Medical Assistance will commission a survey of patients to identify relevant outcomes within a 14disease area. 15 2) Evaluation of a range of research and analysis that looks at relevant patient subgroups 16to ensure consideration of important differences in preferences and clinical characteristics within 17patient subpopulations. 18 3) Scientific Rigor: The Division of Medical Assistance shall require research and 19analysis to comply with good research practices, defined as consideration of the full range of 20relevant, peer-reviewed evidence (e.g., real-world evidence, research from range of sponsors 21including manufacturers), avoid patient harm through over-interpretation of findings of 22“inconclusive” evidence of clinical differences and instead allow time for conduct of additional 23research. 24 (b) Prohibition on Reliance on Discriminatory Measures. The Division of Medical 25Assistance shall not develop or utilize, directly or indirectly through a contracted entity or other 26third-party, a dollars-per-quality adjusted life year or any similar measures or research in 27determining whether a particular health care treatment is cost effective, recommended, the value 28of a treatment, or in determining coverage, reimbursement, appropriate payment amounts, cost- 29sharing, or incentive policies or programs. 3 of 4 30 (c) Appeals and Physician Override Mechanisms. The Division of Medical Assistance 31may not implement any policy limiting patient access to healthcare treatment and services which 32does not contain an appeals or physician override mechanism. Physicians may not be 33discriminated against or otherwise negatively impacted for utilizing available physician override 34mechanisms. 35 SECTION 2. Title II, Chapter 6D of the General Laws, as appearing in the 2018 Official 36Edition, is hereby amended by adding the following section: 37 Section 20. Patient-Centeredness Standards for Health Policy Commission Reviews 38 Section 20 (a) Standards for Patient-Centeredness in Research & Analysis. The Health 39Policy Commission shall ensure that any portfolio of research and analysis relied upon for 40determining the value of a healthcare treatment or service , whether provided by a state agency 41or a third party, impacting enrollee access to healthcare treatments and services, meets standards 42of patient-centeredness. The Health Policy Commission shall publicly provide a summary of 43patient-centeredness standards for any such analysis that includes, but is not limited to: 44 1) Evaluation of a range of research and analysis that includes outcomes prioritized by 45patients and people with disabilities within a specific disease area. If necessary, the Health Policy 46Commission will commission a survey of patients to identify relevant outcomes within a disease 47area. 48 2) Evaluation of a range of research and analysis that looks at relevant patient subgroups 49to ensure consideration of important differences in preferences and clinical characteristics within 50patient subpopulations. 4 of 4 51 3) Scientific Rigor: The Health Policy Commission shall require research and analysis to 52comply with good research practices, defined as consideration of the full range of relevant, peer- 53reviewed evidence (e.g., real-world evidence, research from range of sponsors including 54manufacturers), avoid patient harm through over-interpretation of findings of “inconclusive” 55evidence of clinical differences and instead allow time for conduct of additional research. 56 (b) Prohibition on Reliance on Discriminatory Measures. The Health Policy Commission 57shall not develop or utilize, directly or indirectly through a contracted entity or other third-party, 58a dollars-per-quality adjusted life year or any similar measures or research in determining 59whether a particular health care treatment is cost effective, recommended, the value of a 60treatment, or in determining coverage, reimbursement, appropriate payment amounts, cost- 61sharing, or incentive policies or programs.