CMS Pub. 100-18, ch. 9, § 50.2.2

(Chapter 21 - Rev. 109, Issued: 07-27-12, Effective: 07-20-12; Implementation: 07­ 20-12)

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.