Compliance in Healthcare

Published September 22, 2020 • 2 min read

Compliance in healthcare is the process of following the rules, regulations, and laws that pertain to the healthcare industry.

Healthcare compliance can cover a wide range of practices and include internal and external rules. But most healthcare compliance issues involve patient safety, the privacy and security of patient information, and billing practices.

All healthcare organizations must have some level of compliance, and a compliance plan, to operate effectively. Healthcare compliance keeps healthcare organizations running efficiently and securely, and, via compliance training, ensures that everyone follows the proper procedures and understands what’s expected of them.

Ultimately, healthcare compliance is about providing safe, high-quality patient care and protecting patients’ personal and medical data. Healthcare organizations can continue to improve the quality of care by complying with industry standards and regulations, and taking corrective action when needed.

Healthcare organizations are held to standards, regulations, and laws at the state and federal levels. Healthcare organizations that violate these laws can be hit with massive fines, lawsuits, and/or they may lose their licenses. 

To help medical providers and facilities maintain an effective compliance program,  the U.S. Department of Health and Human ServicesOffice of the Inspector General (OIG) offers a number of resources on its website.

However, laws and regulations do change frequently. A good compliance solution can help you keep track of changes and updates, and tell you what you need to do to be continually in regulatory compliance

Federal Regulations Governing Healthcare Compliance

Here are some of the federal regulations that govern healthcare compliance:

The Social Security Act

Governs funding and requirements for Medicare, Medicaid, the Children’s Health Insurance Program, and more.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH)

Protect patient privacy and mandate that healthcare organizations implement measures to keep patient electronic health records secure. The U.S. Department of Health and Human Services (HHS) administers HIPAA and HITECH.

The Payment Card Industry Data Security Standard (PCI DSS)

Not a federal regulation per se, this standard established and enforced by the payment card industry requires strict privacy and security controls on the cardholder data environment (CDE).

The False Claims Act

Makes it illegal for a healthcare organization to file a false claim for funds from a federal program.

The Patient Protection and Affordable Care Act

Provides requirements for insurance, Medicaid, and more.

The Drug Enforcement Administration and the Food and Drug Administration

Regulate how medication is developed and distributed.

The Department of Health and Human Services and the Office of the Inspector General (OIG): 

Help protect against fraud.

The anti-kickback statute

Makes it illegal for healthcare providers, including physicians, to knowingly and willfully accept bribes or payment of any kind in return for generating Medicare, Medicaid, or other federal healthcare program business.

Who is responsible for healthcare compliance?

Just as healthcare laws and compliance requirements often differ between states, healthcare compliance needs and issues differ between companies.

Typically, a healthcare organization has a compliance officer or department committed to maintaining healthcare compliance. However, to be effective, the healthcare compliance department has to have the authority to create programs to enforce healthcare compliance. The executives must put the framework in place to implement an effective healthcare compliance program.

In addition, every employee has to commit to maintaining healthcare compliance. Healthcare companies can only maintain compliance when every staff member takes responsibility for following procedures and regulations.

Every healthcare organization should develop a culture of accountability that spreads through the company, enabling every employee to understand the importance of healthcare compliance.

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