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Compliance Program Policy and Guidance

Federal regulations at 42 C.F.R. §§422.503 and 423.504 specify the requirements for Medicare Plans to implement an effective Compliance Program.

This section contains information related to the CMS' Compliance Program Policy and Guidance and will assist Medicare Plans and the public in understanding Part C and Part D compliance program requirements.

Compliance Program Guidelines

The Compliance Program Guidelines reflect CMS’ interpretation of the Compliance Program requirements and related provisions.  These guidelines were issued as Chapter 9 of the Medicare Prescription Drug Benefit Manual and Chapter 21 of the Medicare Managed Care Manual. Both Chapters are identical and apply equally to the Medicare Advantage Organizations and Prescription Drug Plan Sponsors.

The final guidelines can be found in the "Related Links" section below.

Compliance Guidelines Focused Trainings

Since the publication of the Compliance Program Guidelines in 2012, the Medicare Part C & D Oversight and Enforcement Group, Division of Compliance Enforcement, has presented a series of focused trainings for the industry on the application of the seven elements of an effective compliance program.  These trainings are designed to provide more in-depth guidance on each of the elements, practical application and best practices used by some Parts C and D sponsors.

While initially these trainings were presented by live webinar, we are now prerecording the trainings to make the audio presentations available to a wider audience.  Posted below are the slides and recording links for trainings that were prerecorded, as well as a brief instructional video on how to navigate the recordings.  In addition, the slides for the earlier presentations that were delivered by live webinar are posted below.

CMS intends to post additional prerecorded focused training sessions on the website.  Notification of the availability of future sessions will be through HPMS.

Part C and Part D Compliance Program Policy and Guidance Mailbox

The Division of Compliance Enforcement (DCE) has a streamlined process for responding timely to compliance program policy questions or inquiries.

Please submit all Compliance Program Policy and Guidance related questions directly to the following mailbox: Parts_C_and_D_CP_Guidelines@cms.hhs.gov