New CMS requirement for clinical trials for patients receiving Medicaid benefits

CMS now requires documentation of the appropriateness of qualified clinical trials for patients receiving Medicaid benefits. The attestation form will require signature of the Principal Investigator, and in some cases, a Referring Physician.

CMS requires that the form be completed and uploaded to the patient's medical record upon enrollment to a qualifying clinical trial. More information is available by referencing this document: How to Complete: The Medicaid Attestation Form on the Appropriateness of Qualified Clinical Trial (pdf).

Please note the following:

• Effective Monday, June 3rd, no clinical trial activities or services that have associated costs may be completed for patients receiving Medicaid benefits until after a completed attestation form is uploaded to the patient's medical record.
• Training will be launched in UNC Health's LMS on Wednesday, May 22nd. All personnel with a research coordinator or research assistant profile in Epic will be required to complete the training, no later than June 3rd. Training will provide details on how to determine when the attestation form is required, as well as how to access, complete, and upload the form.
• Several office hours will be hosted beginning the week of May 27th. Office hours will be open for anyone with questions to join an open discussion with leaders of the various functional areas involved.
• A document of frequently asked questions will be developed over the next several weeks and made available to the research community for reference.

If you have immediate questions, contact This email address is being protected from spambots. You need JavaScript enabled to view it. (UNC-Chapel Hill researchers) or This email address is being protected from spambots. You need JavaScript enabled to view it. (UNC Health researchers).

Thank you for your ongoing commitment to quality and compliance.

Sincerely,

One UNC Clinical Research
UNC-Chapel Hill and UNC Health