Healthcare Compliance

Healthcare is a risky business – High risk that is highly regulated; compliance is a crucial component to ensure the continued safety of patients and staff. But what is healthcare compliance, why is it important, and is it mandatory?


What is compliance in healthcare?
In relation to healthcare, compliance is a term that refers to the process by which healthcare providers and organizations follow the rules and regulations regarding their practice. There are many rules and regulations in healthcare. Some common healthcare rules and regulations are written in the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health ACT (HITECH), and the Patient Safety and Quality Improvement ACT (PSQIA). The rules are often enforced by government-related organizations such as the U.S. Department of Health and Human Services, the Drug Enforcement Administration, the Agency for Healthcare Research and Quality, and the Food and Drug Administration. 

While some view healthcare compliance as unnecessary surveillance and an overbearing intrusion, others recognize that compliance is simply a way for the quality of healthcare to be monitored and improved.

Why is compliance important in healthcare?
Healthcare compliance is important because it allows healthcare providers and organizations to improve their patients’ quality of care. Following rules and regulations in healthcare is critical – if procedures are not properly carried out, healthcare providers or patients could be put at risk. Additionally, healthcare compliance ensures that healthcare providers and organizations are meeting or exceeding the expectations outlined by the government. Ensuring that an organization follows all the given guidelines is essential to protect the organization from any severe consequences or penalties, such as lawsuits or fines.

What is a healthcare compliance program?
A healthcare compliance program is a system utilized by healthcare organizations that develops written policies and procedures in addition to educating and training employees in order to maximize compliance with rules and regulations set out by the government. Healthcare compliance programs are supposed to include a number of elements that maximize the effectiveness of the program.

Are healthcare compliance programs mandatory?
Healthcare compliance programs are necessary for certain healthcare organizations. In March of 2010, the Patient Protection and Affordable Care Act was passed, which stated that the Secretary, HHS, can mandate compliance programs for healthcare providers and organizations that are enrolled in Medicare, Medicaid, or the Children’s Health Insurance Program. For healthcare organizations that meet the above criteria, there is a requirement (written in the “Medicare Managed Care Manual”) that compliance programs include the following elements:

  • Written policies, procedures, and standards of conduct
  • Compliance Officer, Compliance Committee, and High-Level Oversight
  • Effective training and education
  • Effective lines of communication
  • Well-publicized disciplinary standards
  • An effective system for routine monitoring and identification of compliance risks
  • Procedures and system for prompt response to compliance issues

These requirements ensure that healthcare organizations employ a compliance program that promotes strong complaint practices within the organization.