CMS Pub. 100-16, ch. 21, § 50.2.2

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

Sponsors must have a compliance committee in place that oversees the Medicare

compliance program. The sponsor need not have a separate Medicare compliance

committee, as long as the committee addresses Medicare compliance issues. In many

organizations, the compliance committee is chaired by the compliance officer. The

compliance committee serves to advise the compliance officer. The compliance

committee is accountable to, and must provide regular compliance reports to, the

sponsor’s senior-most leader and governing body. Reports on the status of the

compliance program are usually reported through the chairperson of the committee.

Duties of the compliance committee may include, but are not limited to:

• Meeting at least on a quarterly basis, or more frequently as necessary to enable

reasonable oversight of the compliance program;

• Developing strategies to promote compliance and the detection of any potential

violations;

• Reviewing and approving compliance and FWA training, and ensuring that

training and education are effective and appropriately completed;

• Assisting with the creation and implementation of the compliance risk assessment

and of the compliance monitoring and auditing work plan;

• Assisting in the creation, implementation and monitoring of effective corrective

actions;

• Developing innovative ways to implement appropriate corrective and preventative

action;

• Reviewing effectiveness of the system of internal controls designed to ensure

compliance with Medicare regulations in daily operations;

• Supporting the compliance officer’s needs for sufficient staff and resources to

carry out his/her duties;

• Ensuring that the sponsor has appropriate, up-to-date compliance policies and

procedures;

• Ensuring that the sponsor has a system for employees and FDRs to ask

compliance questions and report potential instances of Medicare program

noncompliance and potential FWA confidentially or anonymously (if desired)

without fear of retaliation;

• Ensuring that the sponsor has a method for enrollees to report potential FWA

• Reviewing and addressing reports of monitoring and auditing of areas in which

the sponsor is at risk for program noncompliance or potential FWA and ensuring

that corrective action plans are implemented and monitored for effectiveness; and

• Providing regular and ad hoc reports on the status of compliance with

recommendations to the sponsor’s governing body.

The compliance committee should include individuals with a variety of backgrounds, and

reflect the size and scope of the sponsor. Members of the compliance committee should

have decision-making authority in their respective areas of expertise. Sponsors should

include members of senior management (e.g., CFO, COO), as well as auditors,

pharmacists, registered nurses, and nationally certified pharmacy technicians on the

compliance committee (to the extent that their organization has those positions on staff.).

Other committee members might include personnel experienced in legal issues, statistical

analysts, and staff/managers from various departments within the organization who

understand the vulnerabilities within their respective areas of expertise.