Steven Baruch - Health Care Compliance Association

December 2010
22
The complexity of
compliance basics:
A CCO’s pursuit of
Editor’s note: H. Rebecca Ness is a health care
professional with specific expertise in governance
and compliance. She has 25 years of senior level
management experience in health care and
higher education. As a Compliance Officer and
Governance Director, she designed, developed,
and implemented governance infrastructures,
board education programs, and a corporate
compliance program. Rebecca may be reached at
becness@myfairpoint.net.
Have you ever stopped to think
about the complexity of compliance
basics Pick up any copy of
HCCA’s Compliance Today or other corporate
compliance journal and read the table of
contents. You will find a daunting list of topics
that you as the corporate compliance officer
(CCO) must possess a commanding knowledge
of to keep your organization informed
about current trends, maintain an effective
compliance program, and stay on top of the
proliferation of changes in state and federal
law, as well as all the regulatory agencies that
have a say in running the health care system.
The foundation
First, let’s go back to the starting line where every
CCO professional begins the knowledge quest
marathon. You must be familiar with and have
a working knowledge of the Federal Sentencing
Guidelines (FSG), 1998 OIG Program
Guidance, the 2005 Supplemental Guidance, the
OIG seven elements of an effective compliance
program, and the current OIG Work Plan.
knowledge
By H. Rebecca Ness
The Federal Sentencing Guidelines define
an effective compliance program as one
that “shall be reasonably designed, implemented
and enforced so that the program
is effective in preventing and detecting
criminal conduct.” 1 The two OIG compliance
guidance documents are filed in the Federal
Register, February 23, 1998 2 and January 31,
2005. 3 These documents provide a roadmap
for compliance officers to design an effective
program customized to their organization and
to conduct ongoing evaluation of compliance
program effectiveness. Originating in
the FSG, the seven elements of an effective
compliance program are incorporated in
the OIG 1998 program guidance. These
elements are the essential building blocks for
a compliance program. OIG publishes an
annual Work Plan that outlines a summary of
prospective government initiatives. The OIG
Work Plan, available online, 4 is an essential
tool for individual organizations to identify
and prioritize risk areas within their organization
and develop their own work plan.
The Federal Sentencing Guidelines are a
good example of how government guidance
is a moving target that requires the diligence
of the CCO to remain current with amendments
and recommendations. Created by the
US Sentencing Commission in 1987, the
FSG established uniformity in sentencing
ranges for individual defendants. In 1991,
Congress established sentencing guidelines for
organizations which apply to public, private,
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and not-for-profit entities. Fines were created
for federal crimes, and this change brought
an enhanced focus on effective compliance
programs to mitigate penalties. In 2004,
further amendments to the FSG impacted
compliance programs through the development
of standards increasing governing body
and executive leadership accountability for
knowledge and oversight of the compliance
program. Additional 2004 amendments focus
on sufficient resources to operate the compliance
program, monitoring and auditing for
effectiveness, as well as communication and
training. In 2005, the US Supreme Court
declared the FSG unconstitutional. Although
mandatory sentencing was overturned, the
FSG are still used to advise the determination
of sentences. The most recent amendments,
which went into effect November 1, 2010,
contain new implications for compliance
programs. Key focus areas include remediation
and restitution as well as establishment of a
direct reporting obligation to the governing
authority.
If you have made it through the above
foundational documents, you are ready to
move into the regulatory environment. Major
compliance regulations that all CCOs must be
familiar with include the Deficit Reduction Act
(DRA), the False Claims Act (FCA), Stark Law,
Anti-kickback Statute (AKS), Health Insurance
Portability and Accountability Act (HIPAA
Privacy and Security), Sarbanes-Oxley Act, the
Emergency Medical Treatment and Labor Act
(EMTALA), Fraud Enforcement Recovery Act
of 2009 (FERA), and IRS Form 990. The complexity
lies in both understanding these basic
regulations and ensuring that your organization
complies with the letter of the law.
The next step for the CCO is to learn the
impact on these regulations of the recently
enacted Health Care Reform Law made up of
the Patient Protection and Affordable Care Act