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
The Program Compliance and Oversight Group, Division of Compliance Enforcement, will be conducting a series of focused trainings for the industry via webinar. Initially, topics will consist of each of the seven elements of an effective compliance program as well as a session on FDR oversight. All of the trainings will be publicized on HPMS. Because we have limited audio capacity, the trainings will be offered on a first come, first served basis, measured by the first 600 participants to actually call into the audio line the day of training. Therefore, we encourage multiple participants from the same organization to share one audio line.
Each presentation will be posted on this website in PDF format shortly following the actual training day.
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.
- Compliance Program Guidelines Issuance Memo [PDF, 56KB]
- Compliance Program Effectiveness Self-Assessment Questionnaire [PDF, 165KB]
- Element I Focused Training Power Point [PDF, 655KB]
- Element I Written Ps & Ps and Standards of Conduct Qs and As [PDF, 321KB]
- Element II Focused Training Power Point [PDF, 1MB]
- Element III Focused Training Power Point [PDF, 662KB]
- Element VI Focused Training Power Point [PDF, 1MB]
- Element VI Monitoring and Auditing Q A [PDF, 318KB]
- Element IV-V Focused Training Powerpoint [PDF, 926KB]
- Prescription Drug Plan Compliance Program Guidelines - Publication 100-18, Chapter 9 - Opens in a new window
- Medicare Advantage and Cost Plan Compliance Program Guidelines - Publication 100-16, Chapter 21 - Opens in a new window
- OIG LISTSERV via the OIG Website - Opens in a new window
- General Services Administration (GSA) database of excluded individuals/ entities - Opens in a new window
- Focused Trainings Instructional Video - Opens in a new window
- Element III Focused Training Recording Link - Opens in a new window
- Element IV/V Focused Training Recording Link - Opens in a new window
- Element VI Focused Training Recording Link - Opens in a new window
- Page last Modified: 11/14/2013 4:27 PM
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