The Centers for Medicare & Medicaid Services (CMS) requires documentation of the appropriateness of qualified聽clinical聽trials for patients receiving聽Medicaid聽benefits. The attestation requires signature of the Principal Investigator, and in some cases, a Referring Physician. CMS requires that the attestation form be completed and uploaded to the patient鈥檚 medical record upon enrollment to a聽qualifying聽clinical聽trial.
No clinical trial activities that have associated costs may be completed for patients receiving聽Medicaid聽benefits participating in a qualified clinical trial until after聽a completed attestation form is uploaded to the patient鈥檚 medical record.聽
Failure to complete and upload the attestation form prior to conducting any study-related activities with associated costs may result in those study costs being billed to the research accounts.
Resources:
- Consult your study’s BCA for the qualified clinical trial determination
- Review
- Access the fillable
- Review a 聽(黑料网 Health login required)
Also, please note a mandatory training was issued via 黑料网 Health LMS for all personnel with research roles in Epic in June, 2024. Personnel who have not yet completed the training have been notified.
Please contact Laura Viera, Assistant Vice Chancellor for Clinical Research, with any questions: laura_viera@med.unc.edu