Exclusion Screening

Common Healthcare Compliance Risks


Emptech's founder, Jeff Aleixo


Jeffrey Aleixo

healthcare compliance risks, exclusion screening

Healthcare organizations continually face difficulties when trying to align organizations’ strategic goals and business objectives with critical regulatory and other requirements. To meet these challenges, healthcare providers should establish an effective culture of compliance and stay up-to-date on relevant topics. As a result, they can create plans to minimize healthcare compliance risk, maximize response, educate staff and quickly adapt to the rapidly evolving industry.

Following Regulatory Standards

Healthcare compliance is governed by several different bodies, laws, and regulations. Furthermore, frequent changes and temporary modifications to laws and regulations make healthcare compliance even more complex. Therefore, healthcare organizations should stay current with changing regulations to avoid healthcare compliance risks, and pay attention to:

  • The Health Insurance Portability and Accountability Act (HIPAA), that protects patient privacy, requiring healthcare organizations to implement measures to keep patient records secure. In addition to this, HITECH encourages healthcare organizations to adopt electronic records and further protects patient safety. Consequently, healthcare organizations should have physical and technological safeguards in place to protect patient health information and comply with HIPAA and HITECH laws.
  • According to the False Claims Act, it is illegal to file a false claim for funds from a federal program. This includes any plan or program that provides benefits, including Medicare and Medicaid. Penalties for FCA violations include fines up to three times the amount of the claim, while physicians can also be charged and imprisoned under the criminal FCA.
  • The Department of Health and Human Services (HHS) and the Office of the Inspector General (OIG) investigate fraud, impose program exclusions and monetary penalties for fraud convictions, develop compliance program guidance, and negotiate civil FCA settlements.
Use this detailed guide to handle different data, processes, and reporting challenges involved in meeting healthcare compliance requirements.

Avoiding Healthcare Compliance Risks

The most important goal of healthcare compliance is to provide high-quality care that promotes the safety and well-being of patients. If organizations avoid healthcare compliance risks, they can help their organizations run efficiently and effectively and avoid legal and financial penalties, such as litigation, civil monetary penalties, or sanctions.

To that end, here are some of the common healthcare compliance challenges for healthcare providers and entities to take into consideration:

Regulatory Landscape

Today’s healthcare organizations operate in a highly regulated environment, and regulatory agencies expect all healthcare organizations to take responsibility for every entity and individual conducting business on their behalf. Therefore, it is critical to pay attention to one of the main healthcare compliance risks and that is exercising control over third-party vendors, suppliers, and subcontractors. Also, having compliance programs that allow healthcare organizations to stay on top of evolving laws is difficult, but essential because the penalties for non-compliance are too severe in terms of both financial penalties and potential risks to patients.

OIG Regulation Enforcement

HHS Office of Inspector General plays a crucial role in enforcing federal regulations affecting healthcare fraud, waste, and abuse. Also, the OIG provides a significant number of resources for compliance professionals to utilize in order to prevent healthcare compliance risks. Some of these resources are:

Monthly Exclusion Screening

Exclusions prohibit participation in any federal or state healthcare program and OIG can impose them on individuals or entities on a number of grounds, such as posing unacceptable risks to patient safety and program fraud. Since failure to conduct exclusion screening is one of the common healthcare compliance risks resulting in significant penalties, healthcare providers need to ensure that their employees, contractors, and vendors are not excluded. To do so, it is critical to screen them against the OIG List of Excluded Individuals and Entities (LEIE), the General Services Administration’s System for Award Management (SAM), as well as state exclusion lists.

Emergency Preparedness

Not being prepared for a natural or human-created disaster that leads to a large influx of patients has always been a challenge, especially as healthcare organizations around the world work to address the COVID-19 pandemic. As a result, the Centers for Medicare and Medicaid Services (CMS) have issued a number of emergency preparedness rules to make sure that healthcare organizations have the capacity to absorb and treat surges of COVID-19 patients.


Technology-enabled care and communication with patients constantly grow, but cyberattacks and data breaches make cybersecurity a top concern for healthcare executives, audit committees, and boards. As it becomes one of the usual healthcare compliance risks, cybersecurity calls for the necessary risk assessment activities and robust preventive controls. Hence, healthcare organizations need to apply appropriate measures and regularly educate staff on the latest threats and best practices.

Maintaining Full Healthcare Compliance

The healthcare industry is already fraught with healthcare compliance risks, but expanding laws and regulations and rising violation penalties only add to the complexities and challenges that healthcare organizations face. However, maintaining strict compliance standards is necessary for patient safety and risk management and every staff member should take responsibility for following established policies, procedures, and regulations.To minimize the adverse effects of these trends in the healthcare industry and maximize organizations’ responsiveness to evolving healthcare compliance risks, healthcare organizations need to make sure they have the systems in place to develop and maintain a culture of compliance. Automation technologies can solve many problems that typically come with manual, human-dependent processes, allowing healthcare providers to take a smarter approach to how they handle their operations and compliance concerns. Thus, through a workflow automation process, they can comply with new and changing healthcare regulations, securely store records, and enforce data encryption standards to address growing challenges around cybersecurity.

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