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Schaeffer experts responded to a request for comment on a legislative proposal to embed clinical research into routine care and expand the use of real-world evidence in regulatory decision-making.
Their comments offered two specific recommendations for the legislation:
- Direct the Centers for Medicare and Medicaid Services to develop and evaluate incentives to encourage accurate and consistent reporting of National Clinical Trial identifiers (NCT) in Medicare claims.
- Direct the Department of Health and Human Services to establish a mechanism for secure submission of participant-level identifiers that would allow validation of NCT identifier reporting and linkage of trial participation records to Medicare claims data.
The experts also suggested considering: a test of reimbursement for clinician time spent discussing trial participation with patients; enabling interoperability across electronic medical records, claims and research data when patients consent; and recognizing clinical trial participation as a form of public service.
Read the full comment letter here.
