The June 30, 2023 guidance from the Centers for Medicare and Medicaid Services (CMS) stated that CMS will be holding “patient-focused listening sessions in Fall 2023 after the October 2, 2023 deadline for patients and other interested parties to share patient-focused input on therapeutic alternatives and other section 1194(e)(2) data regarding selected drugs.” In its guidance, CMS referenced these listening sessions as a resource for understanding unmet medical need, acquiring new information from patients, identifying relevant outcomes from patients and caregivers and related to therapeutic alternatives. Recently, more information was provided by CMS regarding the patient-focused listening sessions for the selected drug list.
PIPC Joins Over Researchers, Organizations and Individuals Opposing NIMHD Exclusion of People with Disabilities
PIPC recently submitted a comment letter to the Food and Drug Administration (FDA) offering comments on FDA's proposed revision of guidance on the voluntary use of patient preference information (PPI) in regulatory submissions. The letter encourages FDA to review and incorporate best practices from several leading organizations as it revises its PPI guidance, including the Patient Centered Outcomes Research Institute (PCORI), Innovation and Value Initiative (IVI), and Everylife Foundation for Rare Diseases.