7 Essential Elements of an Effective Compliance Program7 essential

For those of us in the business of radiology practice leadership, compliance with government laws and regulations is a major component of what we do. In fact, radiology is probably one of the most heavily regulated medical specialties.

After all, we deal with equipment that produces ionizing radiation, strong magnets with rapidly changing gradient fields, radioactive materials, highly-regulated and emotionally charged breast imaging, and myriad interventional procedures. Medical physicists, state radiation regulatory agencies, licensing boards, the ACR, OSHA inspectors, and equipment service representatives are kept on speed dial and under the “Favorites” tab in our web browsers. However, do you realize that there are over 30 federal agencies and, depending on the state you work in, another half-dozen or so state agencies that touch our business on a daily basis? Yet for many of our colleagues the topic of compliance is met with that “deer in the headlights” gaze.

New Regulatory Hot Buttons

Quality medical care and patient outcomes notwithstanding, defrauding the federal government has been against the law since 1863 (i.e., False Claims Act, a.k.a. Lincoln Law); this really shouldn’t be a newsflash. Granted, no one is selling rancid provisions or lame mules to the Union Army anymore, but bilking the government out of thousands/millions of dollars by submitting false claims for health care services rendered (or not rendered)? Yeah, you are going to get someone’s attention. Recent health care related law and, more importantly, government enforcement of the law is increasing at an exponential rate. Reasons that the federal crosshairs are trained on radiology should not be a surprise; many of our exams are quite expensive and represent a significant portion of claims paid to beneficiaries of Medicare and Medicaid programs. Further, utilization rates and patient outcomes are often criticized for being incongruous (e.g., overutilization due to ineffective use of exam appropriateness criteria). Finally, Anti-Kickback Statutes and Stark I and II compliance have also accounted for sleepless nights for radiology business managers since the late 1980s.

In March of 2010, President Barack Obama signed the Patient Protection and Affordable Care Act (PPACA) into law. Regulators, agencies, lawyers, judges, insurers, providers, practice administrators, and the general public continue to work at understanding all the implications of this legislation. It is this author’s intent to increase the awareness of radiologists and radiology business managers to one very important provision that immediately impacts the businesses we are accountable for: an effective compliance program.

From a health care and radiology management perspective, this requirement has its roots in a rather unlikely law, the Federal Sentencing Guidelines for Organizations (FSGO):

In 1991, the United States Sentencing Commission promulgated guidelines to govern the imposition of sentences by Federal Judges on organizational defendants. Referred to as the Federal Sentencing Guidelines for Organizations (FSGO), the guidelines impose harsh penalties upon organizations whose employees or other agents have committed federal crimes. Penalties include incarceration, restitution, remedial orders, community service, and substantial fines, based upon a point system for determining severity of offense. The guidelines encourage organizations to develop “effective programs to prevent and detect violations of law,” and prescribe seven “types of steps” that should be included in an effective program. Where organizations demonstrate an effort to implement the seven steps, lower sanctions are levied by Federal Judges.1

One significant aspect of the guidelines is that each organization is responsible for the wrongful acts of its employees, as long as the employees were acting in their official capacity.1 Further, while many large health care corporations have well-honed compliance and ethics programs and infrastructures, small- to medium-sized organizations are especially at risk for ethical misconduct and subsequent sanction by the Federal Sentencing Guidelines for Organizations. These smaller providers are less likely to have formal compliance and ethics programs in place, yet most are subject to such regulations.

Measurement of Program Effectiveness

Subsequent changes to the guidelines require high-level personnel to take steps to measure the effectiveness of their programs. Specifically, recommendations that take effect require that businesses do the following:

1: Ensure that the organization has an effective compliance and ethics program.

2: Periodically evaluate the effectiveness of the organization’s compliance and ethics program.

3: Periodically assess the risk of criminal conduct and take appropriate steps to design, implement, or modify each requirement to reduce the risk of criminal conduct identified through this process.

For companies that have already implemented some form of ethics and compliance program, it is now necessary to gather data to measure the impact of the program on employees’ perceptions of company standards. In cases where organizations do not have a program, it is even more crucial to implement an ethics/compliance program effort and to be able to demonstrate its impact.

The need is clear, if for no other reason than it’s the law. The implication for non-compliance is plastered across daily media headlines. The payoff is the financial health of the organization. This leaves the only unanswered question, what is the compliance situation in your organization?

By Jeff Hayes, MS, CHC, RT (R) (MR)

Jeff Hayes serves as compliance officer for a multi-center, outpatient radiology practice in Phoenix. He is also adjunct faculty at GateWay Community College in Phoenix, where he teaches health care law, ethics, and MRI physics and protocols.


1. Ethics Resource Center. Federal Sentencing Guidelines. http://bit.ly/EthicsFSGO. Accessed Feb. 19, 2014.
2. U.S. Sentencing Commission. 2012 Guidelines Manual. Ch. 8: Federal Sentencing Guidelines for Organizations. http://bit.ly/2012GuidelinesManual. Accessed Feb. 19, 2014.

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