A National COVID-19 Longitudinal Research Database Linked to Centers for Medicare and Medicaid (CMS) Data

STATUS: Active Project

BACKGROUND

The COVID-19 pandemic has precipitated an urgent need to have a near real-time centralized research dataset to conduct patient-centered outcomes research on COVID-19 and generate evidence on effective interventions, especially in vulnerable patient subgroups. Linking clinical and claims data are necessary to address important research on COVID therapeutics and vaccines, long-term complications of COVID, disparate impacts of COVID-19 on vulnerable populations, and the safety-net providers who serve them.

Researchers both within federal government and in non-federal institutions have been hampered by the lack of timely data on health outcomes associated with COVID-19. This project builds on several COVID-related efforts that are led independently by federal agencies and HHS OpDIVs (e.g., AHRQ, ASPE, and NIH) who bring health systems, payment policy, and clinical perspectives to this collaborative project. This project also seeks to bring together agencies across HHS to engage in research to inform policy on the health system response to COVID-19 and to prepare for future emergencies. The final product will be a privacy-preserving, comprehensive linked dataset on individual outcomes and health systems response that could be used internally by HHS agencies and externally by non-federal researchers through the NCATS National COVID Cohort Collaborative (N3C).

PROJECT PURPOSE & GOALS

The overall goal of this project is to enhance COVID-19 data infrastructure for patient-centered outcomes research to produce a national research dataset on COVID-19 available for researchers interested in patient-centered outcomes by linking CMS claims data with clinical electronic health record (EHR) data in the NCATS National COVID Cohort Collaborative (N3C)’s privacy-preserving, secure cloud-based data enclave. This project will support HHS’s priorities to build a national longitudinal data infrastructure on COVID-19 and improve comprehensiveness of the N3C dataset through the inclusion of CMS claims data linked to clinical EHR data contributed by health care organizations participating in the NCATS N3C Data Enclave.

Project Objectives

1. Demonstrate the feasibility of linking clinical EHR data with Medicare claims data using the proposed N3C data linkage strategy and engage researchers interested in patient-centered outcomes research in using the linked research dataset.
2. Link PCOR Researchers to the NCATS N3C Data Enclave to access Medicare Claims Data linked to the N3C Clinical EHR Data;
3. Produce PCOR COVID use cases demonstrating the utility of the linked Medicare claims-N3C clinical data to conduct patient-centered outcomes research on COVID-19, including potential evaluation of economic outcomes.
4. Support the joint activities of the OS-PCORTF COVID Collaborative;
5. Assess the feasibility of linking clinical EHR data with Medicaid claims data using the proposed N3C data linkage strategy.

If linking Medicaid claims to EHR data is deemed successful based on results from the feasibility assessment, then the following optional objectives will be carried out upon approval by ASPE.

6. Link PCOR Researchers to NCATS N3C Data Enclave to access Medicaid Claims Data linked to the N3C Clinical EHR Data; and,
7. Produce PCOR COVID use cases demonstrating the utility of the linked Medicaid claims-N3C clinical data to conduct patient-centered outcomes research on COVID-19.