Submitted electronically to RE: Response to Centers for Medicare & Medicaid Services February 2024 Request for Information on Research Data Request and Access Policy Changes – Updated March 1, 2024

• The proposed pricing structure for the access to the CCW VRDC and RIF Data will create a substantial cost burden for all institutions and significantly impede the ability of emerging research institutions and early-stage researchers to conduct research using RIF Data. [...] Confining Research Using RFI Data to the CCW VRDC will Limit the Types of Research Conducted The current CMS system permits researchers to obtain physical data extracts for use on institutional systems that meet CMS prescribed data security standards. [...] They have worked diligently to develop secure data enclaves that conform to the CMS Requirements and Guidance for Security and Privacy Controls1 that are required per the terms of CMS Data Use Agreements (DUA) that data users must enter to gain access to RFI Data. [...] Sensitive Personal and Government-Related Data Conclusion: COGR and its member institutions believe that the proposed policy changes will severely impair the ability of institutions and researchers, particularly emerging research institutions and early- stage researchers and trainees, to access the CMS RFI data that is vital to the conduct of epidemiological and health policy research. [...] Accordingly, we urge CMS to either withdraw the proposed policy changes and maintain the current system of data distribution, or, at a minimum, delay the proposed changes, including the assessment of new project fees for physical data extracts, to allow additional time to further engage with the research community, federal research funding agencies, and the Office of Management and Budget (OMB)7 t.