By Representative Decker of Cambridge, a petition (accompanied by bill, House, No. 1358) of Marjorie C. Decker relative to health care research and decision-making centered on patients and persons with disabilities. Health Care Financing.
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Date
Branch
Action
7/24/2025
House
7/24/2025 HouseBill reported favorably by committee and referred to the committee on House Ways and Means
6/16/2025
Joint
6/16/2025 JointHearing rescheduled to 06/23/2025 from 09:00 AM-01:00 PM in B-1
6/16/2025
Joint
6/16/2025 JointHearing scheduled for 06/23/2025 from 09:00 AM-01:00 PM in A-1
4/7/2025
Senate
4/7/2025 SenateSenate concurred
4/3/2025
House
4/3/2025 HouseDischarged to the committee on Public Health
2/27/2025
Senate
2/27/2025 SenateSenate concurred
2/27/2025
House
2/27/2025 HouseReferred to the committee on Health Care Financing
Question: Should H1358, An Act advancing health care research and decision-making centered on patients and people with disabilities be reported out with Recommendation: Ought to pass, report to the House?
Chapter 118E of the General Laws is hereby amended by adding the following section:
▸SECTION 80
: Patient-Centeredness
▸SECTION 80
(a) Standards for Patient-Centeredness in Research & Analysis. The Division of Medical Assistance shall ensure that any portfolio of research and analysis relied upon for decision-making, whether provided by a state agency or a third party, impacting enrollee access to healthcare treatments and services, meets standards of patient-centeredness. The Division of Medical Assistance shall publicly provide a summary of patient-centeredness standards for any such analysis that includes, but is not limited to:
1) Evaluation of a range of research and analysis that includes outcomes prioritized by patients and people with disabilities within a specific disease area. If necessary, the Division of Medical Assistance will commission a survey of patients to identify relevant outcomes within a disease area.
2) Evaluation of a range of research and analysis that looks at relevant patient subgroups to ensure consideration of important differences in preferences and clinical characteristics within patient subpopulations.
3) Scientific Rigor: The Division of Medical Assistance shall require research and analysis to comply with good research practices, defined as consideration of the full range of relevant, peer-reviewed evidence (e.g., real-world evidence, research from range of sponsors including manufacturers), avoid patient harm through over-interpretation of findings of “inconclusive” evidence of clinical differences and instead allow time for conduct of additional research.
(b) Prohibition on Reliance on Discriminatory Measures. The Division of Medical Assistance shall not develop or utilize, directly or indirectly through a contracted entity or other third-party, a dollars-per-quality adjusted life year or any similar measures or research in determining whether a particular health care treatment is cost effective, recommended, the value of a treatment, or in determining coverage, reimbursement, appropriate payment amounts, cost-sharing, or incentive policies or programs.
(c) Appeals and Physician Override Mechanisms. The Division of Medical Assistance may not implement any policy limiting patient access to healthcare treatment and services which does not contain an appeals or physician override mechanism. Physicians may not be discriminated against or otherwise negatively impacted for utilizing available physician override mechanisms.
▸SECTION 2
Chapter 6D of the General Laws is hereby amended by adding the following section:
▸SECTION 20
Patient-Centeredness Standards for Health Policy Commission Reviews
▸SECTION 20
(a) Standards for Patient-Centeredness in Research & Analysis. The Health Policy Commission shall ensure that any portfolio of research and analysis relied upon for determining the value of a healthcare treatment or service , whether provided by a state agency or a third party, impacting enrollee access to healthcare treatments and services, meets standards of patient-centeredness. The Health Policy Commission shall publicly provide a summary of patient-centeredness standards for any such analysis that includes, but is not limited to:
1) Evaluation of a range of research and analysis that includes outcomes prioritized by patients and people with disabilities within a specific disease area. If necessary, the Health Policy Commission will commission a survey of patients to identify relevant outcomes within a disease area.
2) Evaluation of a range of research and analysis that looks at relevant patient subgroups to ensure consideration of important differences in preferences and clinical characteristics within patient subpopulations.
3) Scientific Rigor: The Health Policy Commission shall require research and analysis to comply with good research practices, defined as consideration of the full range of relevant, peer-reviewed evidence (e.g., real-world evidence, research from range of sponsors including manufacturers), avoid patient harm through over-interpretation of findings of “inconclusive” evidence of clinical differences and instead allow time for conduct of additional research.
(b) Prohibition on Reliance on Discriminatory Measures. The Health Policy Commission shall not develop or utilize, directly or indirectly through a contracted entity or other third-party, a dollars-per-quality adjusted life year or any similar measures or research in determining whether a particular health care treatment is cost effective, recommended, the value of a treatment, or in determining coverage, reimbursement, appropriate payment amounts, cost-sharing, or incentive policies or programs.
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SECTION 1. Chapter 118E of the General Laws is hereby amended by adding the following section:
Section 80: Patient-Centeredness
Section 80 (a) Standards for Patient-Centeredness in Research & Analysis. The Division of Medical Assistance shall ensure that any portfolio of research and analysis relied upon for decision-making, whether provided by a state agency or a third party, impacting enrollee access to healthcare treatments and services, meets standards of patient-centeredness. The Division of Medical Assistance shall publicly provide a summary of patient-centeredness standards for any such analysis that includes, but is not limited to:
1) Evaluation of a range of research and analysis that includes outcomes prioritized by patients and people with disabilities within a specific disease area. If necessary, the Division of Medical Assistance will commission a survey of patients to identify relevant outcomes within a disease area.
2) Evaluation of a range of research and analysis that looks at relevant patient subgroups to ensure consideration of important differences in preferences and clinical characteristics within patient subpopulations.
3) Scientific Rigor: The Division of Medical Assistance shall require research and analysis to comply with good research practices, defined as consideration of the full range of relevant, peer-reviewed evidence (e.g., real-world evidence, research from range of sponsors including manufacturers), avoid patient harm through over-interpretation of findings of “inconclusive” evidence of clinical differences and instead allow time for conduct of additional research.
(b) Prohibition on Reliance on Discriminatory Measures. The Division of Medical Assistance shall not develop or utilize, directly or indirectly through a contracted entity or other third-party, a dollars-per-quality adjusted life year or any similar measures or research in determining whether a particular health care treatment is cost effective, recommended, the value of a treatment, or in determining coverage, reimbursement, appropriate payment amounts, cost-sharing, or incentive policies or programs.
(c) Appeals and Physician Override Mechanisms. The Division of Medical Assistance may not implement any policy limiting patient access to healthcare treatment and services which does not contain an appeals or physician override mechanism. Physicians may not be discriminated against or otherwise negatively impacted for utilizing available physician override mechanisms.
SECTION 2. Chapter 6D of the General Laws is hereby amended by adding the following section:
Section 20. Patient-Centeredness Standards for Health Policy Commission Reviews
Section 20 (a) Standards for Patient-Centeredness in Research & Analysis. The Health Policy Commission shall ensure that any portfolio of research and analysis relied upon for determining the value of a healthcare treatment or service , whether provided by a state agency or a third party, impacting enrollee access to healthcare treatments and services, meets standards of patient-centeredness. The Health Policy Commission shall publicly provide a summary of patient-centeredness standards for any such analysis that includes, but is not limited to:
1) Evaluation of a range of research and analysis that includes outcomes prioritized by patients and people with disabilities within a specific disease area. If necessary, the Health Policy Commission will commission a survey of patients to identify relevant outcomes within a disease area.
2) Evaluation of a range of research and analysis that looks at relevant patient subgroups to ensure consideration of important differences in preferences and clinical characteristics within patient subpopulations.
3) Scientific Rigor: The Health Policy Commission shall require research and analysis to comply with good research practices, defined as consideration of the full range of relevant, peer-reviewed evidence (e.g., real-world evidence, research from range of sponsors including manufacturers), avoid patient harm through over-interpretation of findings of “inconclusive” evidence of clinical differences and instead allow time for conduct of additional research.
(b) Prohibition on Reliance on Discriminatory Measures. The Health Policy Commission shall not develop or utilize, directly or indirectly through a contracted entity or other third-party, a dollars-per-quality adjusted life year or any similar measures or research in determining whether a particular health care treatment is cost effective, recommended, the value of a treatment, or in determining coverage, reimbursement, appropriate payment amounts, cost-sharing, or incentive policies or programs.