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MD - Health Care Compliance Association

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A new value proposition ...continued from page 41<br />

officer responsible for coordinating all compliance<br />

efforts can result in an integrated and more<br />

effective compliance program.<br />

Although SOX 404 focuses on the COSO<br />

objective of the reliability of financial reporting,<br />

there are areas where there will be overlap with<br />

internal controls over operations and compliance<br />

with applicable regulations. 12 Some compliance<br />

controls may be relevant to financial<br />

reporting, thus there is the prospect of including<br />

the COSO compliance objective with SOX<br />

financial reporting control efforts to further<br />

drive business performance. A compliance officer<br />

can also play a role in a company’s disclosure<br />

controls and procedures under SOX section<br />

302, particularly non-financial information that<br />

is required by the SEC to be divulged.<br />

Moreover, for complex industries, an ineffective<br />

regulatory compliance function in which violations<br />

of laws and regulations could have a material<br />

effect on the reliability of financial reporting<br />

is said to be regarded as at least a significant<br />

deficiency and a strong indicator of a material<br />

weakness under the new auditing standard. 13<br />

Reliance on compliance work and activities<br />

by external auditors. Another opportunity<br />

arises from the flexibility that public<br />

auditors are afforded under the new auditing<br />

standard established by the PCAOB, to use<br />

the work of others when evaluating internal<br />

control effectiveness. The PCAOB notes that<br />

this is “strong encouragement for companies<br />

to develop high-quality internal audit, compliance,<br />

and other such functions” 14 (emphasis<br />

added). Accordingly the work of the compliance<br />

program can serve a dual purpose in<br />

supporting an efficient audit of internal control,<br />

while providing documentation of the<br />

effectiveness of the compliance program itself.<br />

Areas of overlap under COSO. A significant<br />

area of overlap between SOX 404 and<br />

the FSG involves control environment objectives<br />

under COSO. Several control environment<br />

factors entail activities that have become<br />

the province of the compliance program. For<br />

example, the integrity and ethical values<br />

attribute involves the code of conduct which<br />

is a compliance program responsibility where<br />

the function exists. The hotline is often managed<br />

by the compliance department and can<br />

be viewed as a control environment and/or<br />

information and communication factor.<br />

Training on the code of conduct and fraud<br />

areas is considered an attribute under information<br />

and communication. Many of the human<br />

resource policies and practices attributes under<br />

the control environment entail features of a<br />

compliance program under the FSG (e.g.,<br />

employee background checks, appropriate<br />

incentives, and disciplinary practices).<br />

A new provision of the organizational sentencing<br />

guidelines is the importance of performing<br />

on-going risk assessments on the<br />

likelihood of compliance violations, and to<br />

use those results to modify features of the<br />

compliance program, and to prioritize compliance<br />

resources and activities. Again, this is<br />

similar to the expectations for fraud control<br />

under COSO and the PCAOB.<br />

If you can’t beat them, join them. In the<br />

health care and pharmaceutical industries and<br />

other highly regulated business sectors, compliance<br />

programs and senior compliance officers<br />

have become customary and an expectation<br />

of government regulators and enforcement<br />

agencies. Congress and government<br />

agencies have even made clear their perspective<br />

that a compliance function should be<br />

freestanding from the general counsel and the<br />

finance functions. 15 Not surprisingly, compliance<br />

programs did not become the norm<br />

until they were foisted on several organizations<br />

through agreements with the government<br />

known as corporate integrity agreements<br />

(CIA). The enforcement of the False<br />

Claims Act in health care resulted in CIAs<br />

that have mandated compliance programs,<br />

which essentially track the elements of an<br />

effective compliance program under the FSG.<br />

Interestingly, the SEC has started to require<br />

certain compliance measures, such as the<br />

appointment of a compliance officer, in a settlement<br />

through a consent judgment. 16<br />

Already in response to the mutual fund scandals,<br />

we’ve seen the SEC issue a new rule<br />

requiring registered investment companies<br />

and advisors to designate a chief compliance<br />

officer, and to have ethics codes and policies<br />

and procedures designed to prevent violations<br />

of securities laws.<br />

So an additional benefit of being able to<br />

demonstrate the existence of an effective<br />

compliance program is that the SEC or other<br />

enforcement agency will be less likely to<br />

impose one on the program and/or will<br />

reduce the scope and extent of the CIA<br />

terms. Of course, this is in addition to the<br />

mitigation of penalties under the FSG for<br />

having an effective compliance program. The<br />

burdens of a mandated program are heavy<br />

indeed (annual reporting obligations, retention<br />

of an independent review organization,<br />

penalties for CIA failures, etc.).<br />

Finally—Effectiveness<br />

It has been implied in this discussion, that the<br />

existence of a compliance program with the<br />

features described in the FSG will constitute<br />

an effective one. In truth, it remains to be<br />

better defined what the government will<br />

accept as proof of an effective program.<br />

Unfortunately, data from the U.S. Sentencing<br />

Commission is somewhat limited in demonstrating<br />

any trends that the FSG may have on<br />

reducing penalties and influencing corporate<br />

behavior, and it is empirically difficult to test<br />

its impact. 17 Given the growing awareness of<br />

ethics and compliance programs, one might<br />

January 2006<br />

42<br />

<strong>Health</strong> <strong>Care</strong> <strong>Compliance</strong> <strong>Association</strong> • 888-580-8373 • www.hcca-info.org

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