CMS’ requirement is that participants in the audit function be knowledgeable about CMS
operational requirements for the areas under review. In areas highly technical and specialized
such as formulary administration, coverage determinations and appeals and grievances, the
burden is on the sponsor to demonstrate what specialized knowledge the auditor has that
qualifies him or her to conduct the audit of those areas. Many sponsors have found it
extremely helpful to have Part D policy experts and medical professionals (e.g. pharmacists,
pharmacy technicians, nurses, physicians) involved with auditing and monitoring activities
and/or validating the results of those oversight activities.