If you are part of a compliance team in a Medicare Managed Care Plan or a Prescription Drug Plan (also known as
a Sponsor), you are undoubtedly familiar
with the Compliance Program Guidelines1
(Guidelines) and Chapters 21 and 9 (the chapters) in the Medicare Managed Care Manual
(MMCM). 2 Section 50 of the MMCM neatly
communicates the elements of an effective compliance program, including Section
50.1 — Element I: Written Policies, Procedures
and Standards of Conduct. However, the
remainder of Section 50.1 provides little detail
about what written policies and procedures a
compliance program should implement.
The Centers for Medicare & Medicaid
Services (CMS) has always maintained that the
guidance in the chapters is intentionally vague
to allow Sponsors the freedom to draft a com-
pliance program that can be tailored to fit their
individual organizations. Having the good
fortune of knowing the authors of the
chapters, I believe their rationale is
both fair and reasonable. However,
the vague nature of the guidance
provides some anxiety for many
Sponsors, especially the smaller ones.
I have often asked myself the
question, “If I was hired by a Sponsor
to be its compliance officer, what policies and procedures would I create to ensure
my compliance program was effective?” After
spending the last six years in a consulting
capacity, I was recently hired as a Director of
Compliance. I no longer need to ask that question. Instead of wondering, I am now updating
policies and procedures for the organization’s
compliance program. This has given me the
opportunity to answer my own question.
The Seven Elements
The Guidelines consist of seven elements
of an effective compliance program, which
are based upon Chapter 8 of the Federal
Sentencing Commission’s November 1, 2007
by Scott Robinson, CFE, CHC, CPA
Writing specific policies for
the Seven Elements, Part 1:
Elements I and II
» CMS’s Compliance Program Guidelines are purposely general in nature to allow Sponsors to tailor their compliance
programs to their own organization.
» Sponsors should create policies and procedures around the seven elements of an effective compliance program in a
manner or level that is most comfortable for them.
» Policies and procedures should include the guidance CMS provides in the Guidelines.
» The policies and procedures should be distributed to all employees when they are created, when they are updated,
and annually thereafter.
» Do not forget to distribute the policies and procedures to your temporary employees, volunteers, board members,
C-suite management, and delegated entities.
Scott Robinson ( email@example.com) is the Director of
Compliance at Superior Vision in Linthicum, MD.