Q. Why do we need the Medicaid Attestation? 

Medicaid amended a section of the Consolidated Appropriations Act to mandate coverage of routine costs for qualifying clinical trials.  It is a Federal and State directive to use the Medicaid Attestation form to certify that the study is qualifying and appropriate for the research participant. The form must be on file in our electronic health record (Epic). 

Q. Why is the process so manual?  

We explored different ways to make the process less manual, but unfortunately, we were unable to use the research consent functionality or DocuSign, therefore, to fulfil the federal requirement we decided to start with a manual process.  Please be assured that we will continue to work with the Epic team to find a less manual process.  

Q. Do we need to get two signatures on the form?   

No. Although the form has space for two signatures, you only need either the Principal Investigator or the Health Care Provider’s signature.  

For this process, a Health Care Provider refers the research participant to a qualifying clinical trial.  

Q. What happens if the Principal Investigator is away and cannot sign the form? 

If the Principal Investigator is not available due to travel or the nature of the study, it would be appropriate for the attending or the provider taking care of the patient on the PI’s behalf to sign the form. 

Q. Why do we need a “wet signature” on the Medicaid Attestation form?  

We are diligently working with Epic and other vendors to find a way to make the process less manual, however, we currently need the signed form uploaded to comply with this federal requirement. 

Q. Is the form required for all research participants?  

The Medicaid Attestation is required for all research participants that: 

   1. Consent to a study with a Prospective Reimbursement Analysis (PRA),  

        a.  with items or services billed to insurance, and 

   2. The study is qualifying, and 

   3. The participant’s primary insurance is Medicaid.  

See the diagram below: 

Q. What studies require that we complete the Medicaid Attestation? 

Only the studies that have a PRA with items and services billable to insurance are required to complete the form.   

Q. How do we know if the study is qualifying according to Medicaid?  

Medicaid has specific qualifying guidelines that are outlined in the JHM policy.  However, as an institution, we will follow the Medicare qualifying criteria already used for each Prospective Reimbursement Analysis (PRA).  You can find a tip sheet with a complete explanation here.  

The qualifying determination is performed by CRSS.  You can find it by looking at the qualifying table in the PRA or by looking at question number six in OnCore’s QCT Checklist (on the Coverage Analysis Console). 

 

Q. What happens if the form is not signed? 

Not being able to provide the Medicaid Attestation Form to the Federal government is a violation of the Consolidated Appropriations Act and might result in the University and/or Health System refunding any routine costs related to the participants involved in the research study.  

Q. Who completes the Medicaid Attestation? 

The Principal Investigator and the research coordinators/nurses will receive an in-basket message in Epic with the information necessary to complete the form.  Each study team must meet and decide who should oversee completing the form, collecting the signature, and scanning the form into Epic’s Media Tab.  

 
 

Q. How do we receive the form? Who receives the form? 

The Medicaid Attestation form may be accessed from this website.   

Information about the research participant and how to complete the form will be sent to the research coordinator/nurse using an Epic in-basket message. 

Q. Who can scan the Medicaid Attestation in Epic?  

Epic Research Coordinators with Scanning or Research Coordinator with Scheduling and Scanning job roles have the security to scan the signed form into Epic’s Media tab. 

Alternatively, follow your department or clinical area's usual process for uploading forms into the Media Tab. 

Q. Does that mean that we can see patients with Medicaid insurance from all states? 

No. All other billing, state and federal laws still apply.  

Q. Who can I contact with questions?

  
Please contact the Office of Clinical Research Billing Compliance with questions at: [email protected] or Liza Rodríguez at [email protected] or call 667-208-8898.