CMS Pub. 100-18, ch. 9, § 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 adequ ate

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.