September 28th, 2022
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We are pleased to have the opportunity to express our views on the Agency for Health Research and Quality (AHRQ) Draft for the Analysis of Requirements for Coverage with Evidence Development (CED) –Topic Refinement.
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
We support AHRQ’s overall report and recommendations for the Centers for Medicare and Medicaid Services (CMS) to update their CED requirements. It has been almost eight years since the CED has been updated. We appreciate the details and explicit milestones and support the need to achieve diversity in CED studies of Medicare beneficiaries. However, we recommend the following additions to the proposed update:
- While we understand why AHRQ may want to shorten the phrasing of requirement “H”, we urge the inclusion of specific examples, so that researchers will be held accountable if they fail to comply. Here is an example of possible proposed text: The study population reflects the demographic and clinical complexity among the Medicare beneficiaries who are the intended users of the product. This should include, but not limited to, the intended users’ racial/ethnic backgrounds, gender, and socio-economic status.
- For proposed requirement “L”, we urge the inclusion of the codes for possible covariates when using secondary data. A covariate’s influence on key exposures and outcomes is important; therefore the codes are needed to ensure replicability and consistency for future researchers.
Thank you for considering our recommendations. If you have any questions, we can be reached at info@center4research.org or (202) 223-4000.