The Centers for Medicare and Medicaid Services have issued a new requirement for Qualifying Clinical Trials. A Health Care Provider must provide attestation regarding the appropriateness of the qualifying clinical trial.
How will Lurie Children's and Manne Research Institute implement this new regulation?
- Beginning April 1, the signed Medicaid Attestation Form will need to be uploaded to Electronic Medical Record (Epic) for all patients completing informed consent on an FDA-regulated clinical trial.
What does this mean for you?
- The study Principal Investigator and a Health Care Provider must sign the Research Medicaid Attestation Form beginning April 1.
- In some instances, the Principal Investigator may also be the Health Care Provider.
- The form should be completed at the time of informed consent and included when sending to HIM for scanning in to Epic.
