CMS requires the DVC and the SO to perform the activities outlined below to prepare for the on-site or virtual visit.
Table 10: Preparing for DVC On-Site or Virtual Visit| Activity | Owner | Activity Details |
|---|
| Select dates
and location | DVC | - Determine whether an on-site or virtual visit is appropriate for the DV review, and if an on-site visit, determine the most appropriate locations of the visit, like the SO’s facility, Pharmacy Benefit Manager’s (PBM’s) facility, or another delegated entity’s facility
- Document the rationale for deciding to conduct a virtual visit, if applicable
|
| Develop agenda | DVC and SO | - Structure the agenda to include an entry conference, exit conference, sessions with the report owners of each reporting section
- Sessions should include interviews and demonstrations of the data systems for each reporting section
|
| Create sign-in sheet | DVC | - Include contact information for report owners and subject matter experts in case CMS requires a follow-up, if used
|
Next, let’s learn how to review the Data Extraction and Sampling Instructions, starting with an overview of the process.