CMS Pub. 100-18, ch. 9, § 50.6.1

42 C.F.R. §§ 422.503(b)(4)(vi)(F), 423.504(b)(4)(vi)(F)

Sponsors must undertake monitoring and auditing to test and confirm compliance

with Medicare regulations, sub-regulatory guidance, contractual agreements, and

all applicable Federal and State laws, as well as internal policies and procedures to

protect against Medicare program noncompliance and potential FWA.

Monitoring activities are regular reviews performed as part of normal operations to

confirm ongoing compliance and to ensure that corrective actions are undertaken

and effective. An audit is a formal review of compliance with a particular set of

standards (e.g., policies and procedures, laws and regulations) used as base

measures.

Sponsors must develop a monitoring and auditing work plan that addresses the

risks associated with the Medicare Parts C and D benefits. The compliance officer

and compliance committee are key participants in this process.

Sponsors must have a system of ongoing monitoring and auditing that is reflective of

its size, organization, risks and resources to assess performance in, at a minimum,

areas identified as being at risk. The monitoring and auditing work plan must be

coordinated, overseen and/or executed by the compliance officer, assisted if desired

by the compliance department staff and/or the compliance committee. The

compliance officer may coordinate with the audit department, if any, in connection

with these activities. The compliance officer must receive regular reports from the

audit department or from those who are conducting the audits regarding the results

of auditing and monitoring and the status and effectiveness of corrective actions

taken. It is the responsibility of the compliance officer or his/her designee to provide

updates on monitoring and auditing results to the compliance committee, the CEO,

senior leadership and the sponsor’s governing body. In addition, for specific work

coordinated with the audit department, the compliance officer and Chief Audit

Executive may share the responsibility to provide updates on monitoring and

auditing results to the compliance committee, the CEO, senior leadership and the

sponsor’s governing body.