CMS Pub. 100-16, ch. 21, § 30

Section 1860D-4(c)(1)(D) of the Act, 42 C.F.R. §§ 422.503(b)(4)(vi), 423.504(b)(4)(vi)

All sponsors are required to adopt and implement an effective compliance program,

which must include measures to prevent, detect and correct Part C or D program

noncompliance as well as FWA.

The compliance program must, at a minimum, include the following core requirements:

1. Written Policies, Procedures and Standards of Conduct;

2. Compliance Officer, Compliance Committee and High Level Oversight;

3. Effective Training and Education;

4. Effective Lines of Communication;

5. Well Publicized Disciplinary Standards;

6. Effective System for Routine Monitoring and Identification of Compliance Risks;

and

7. Procedures and System for Prompt Response to Compliance Issues.

In order to be effective, a sponsor’s compliance program must be fully implemented, and

should be tailored to each sponsor’s unique organization, operations and circumstances.

A compliance program will not be effective unless sponsors devote adequa te resources to

the program. Adequate resources include those that are sufficient to do the following:

1. Promote and enforce its Standards of Conduct

2. Promote and enforce its compliance program;

3. Effectively train and educate its governing body members, employees and FDRs;

4. Effectively establish lines of communication within itself and between itself and

its FDRs;

5. Oversee FDR compliance with Medicare Part C and D requirements;

6. Establish and implement an effective system for routine auditing and monitoring;

and

7. Identify and promptly respond to risks and findings.

CMS will consider a sponsor’s size, structure, business model, activities, the extent of its

delegation of responsibilities to other entities, the breadth of its operation, and the risks it

faces in evaluating whether adequate resources have been devoted to the compliance

program.