Clinical trials generate valuable evidence about new treatments, but linking participation in those trials to real-world data remains difficult. Medicare claims data is a critical link, but clinical trial participation must be documented accurately and consistently.
Since 2014, the Centers for Medicare & Medicaid Services has required providers to include an eight-digit National Clinical Trial (NCT) identifier on Medicare claims for routine care provided as part of a clinical trial. However, Schaeffer Scholars Sidra Haye and Mireille Jacbson argue in JAMA Health Forum that the current system falls short. Drawing on research examining participation in the Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, a large study of amyloid PET scans for dementia care, the authors identify extensive errors in NCT code reporting. For example, some claims included the IDEAS trial code even though the beneficiary never received a PET scan, which was a condition of being in the study. Other beneficiary files had the NCT code for the IDEAS study years after the study ended.
More accurate reporting of NCT codes could help evaluate the performance of new treatments, promote more representative clinical trial enrollment and improve coverage decisions. The authors suggest several policies to improve reporting:
- Create financial incentives for accurate reporting: Medicare currently does not reimburse for the administrative work required to document NCT codes. A modest payment tied to accurate reporting could meaningfully shift clinician behavior.
- Simplify reporting requirements: Clinicians must currently document not just the NCT identifier but also specific diagnosis codes and billing modifiers. Streamlining this process would reduce friction and improve compliance.
- Strengthen data infrastructure: Requiring trial sponsors to submit Medicare beneficiary identifiers to CMS, improving data infrastructure or expanding code auditing may also help.
The bottom line: Unreliable reporting of NCT codes is a missed opportunity to generate and link data that can inform scientific progress. Relatively small policy changes can unlock a trove of clinical trial data that Medicare has long recognized as valuable.
