We encourage the public to participate in the development of our research projects. Comments can be submitted for: Analysis of Requirements for Coverage with Evidence Development (CED) (Available for comment until September 28, 2022) The objective of this report is to describe the process and resulting recommendations to CMS for an update to the Coverage with Evidence Development (CED) study design requirements. We aimed to refine the study design requirements so that investigators are efficient in completing studies that contribute to an evidence base with the goal of ending the CED process when there is 1) sufficient evidence for a coverage NCD; 2) sufficient evidence for a non-coverage NCD; or 3) a decision to defer the coverage decision to a Medicare Administrative Contractor (MAC). Our goal for the set of requirements is that they will guide investigators to collect and use data generated in the care of patients to produce strong evidence about the health outcomes from use of products by Medicare beneficiaries, with integrity in the scientific process and transparency at all stages. About us: AHRQ's Effective Health Care Program is committed to providing the best available evidence on the outcomes, benefits and harms, and appropriateness of drugs, devices, and health care services and by helping health care professionals, patients, policymakers, and health care systems make informed health care decisions. The program partners with research centers, academic institutions, health professional societies, consumer organizations, and other stakeholders to conduct research, evidence synthesis, evidence translation, dissemination, and implementation of research findings. To learn more: https://effectivehealthcare.ahrq.gov/ Contact us at epc@ahrq.hhs.gov |
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