Compliance in healthcare is how an organization follows the rules, regulations, and laws that pertain to the healthcare industry.

Healthcare compliance covers a broad range of practices, including 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 type of compliance plan to operate effectively. Healthcare compliance keeps healthcare organizations running efficiently and securely to assure that everyone follows the proper procedures.

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

What Is Healthcare Compliance?

Healthcare organizations are held to standards, regulations, and laws at the state and federal levels. A healthcare organization that violates these laws can face regulatory fines, lawsuits, exclusion from government healthcare programs, or loss of operating licenses.

To help medical providers and facilities maintain an effective compliance program, the U.S. Department of Health and Human Services’ Office of the Inspector General (OIG) offers numerous resources on its website. That said, laws and regulations change frequently. A good compliance solution can help you keep track of changes and updates to tell you what you need to do to maintain 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 secure patient electronic health records. The U.S. Department of Health and Human Services (HHS) administers HIPAA and HITECH.

The False Claims Act

Makes it illegal for a healthcare organization to file a false claim for funds from a federal government program. This can be overcharging for services rendered, not providing the full services promised, or charging for services that were never necessary.

The Patient Protection and Affordable Care Act

Provides requirements for insurance, Medicaid, and more.

The Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA)

Regulate how a medication is developed and distributed.

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?

Typically a healthcare organization has a compliance officer or department assigned to maintain healthcare compliance. To be effective, the healthcare compliance function must be empowered by senior leadership to create and implement an effective healthcare compliance program.

In addition, every employee should help to maintain healthcare compliance. Healthcare companies can only maintain compliance when every staff member takes responsibility for following procedures, regulations, and professional standards. Compliance guidance should be readily available when employees have questions or compliance concerns.

Every healthcare organization should develop a culture of compliance and accountability that spreads through the company. Routine compliance training enables every employee to understand the importance.

How Do Healthcare Organizations Assure Compliance?

The first step is to build a “culture of compliance.” This means implementing measures to assure that everybody in the organization knows how his or her activities affect overall healthcare compliance – and that everyone endeavors to follow all laws and regulations rigorously.

When errors occur, companies with a healthcare compliance culture aim to investigate the root cause and implement corrective actions to prevent such mistakes from happening again.

A robust compliance program and culture won’t happen by accident. Senior leadership must set the tone from the top and lead by example with high standards of conduct. A compliance officer supported by a specialized staff needs to define disciplinary guidelines, perform routine audits, and conduct compliance training to assure the organization abides by applicable regulations.

Take Advantage of Compliance Plans

To become compliant organizations must have a healthcare compliance plan, including documented rules, procedures, and standards of conduct.

In addition, the OIG recommends that hospitals focus on risk areas (such as invoicing for services not rendered, upcoding, unbundling, and redundant billing), medical necessity, anti-kickback and self-referral issues, bad debts, credit balances, records retention, and other issues.

A healthcare compliance strategy should also consider risk areas identified by internal audits and comprehensive error rate testing (CERT) findings. The CERT program monitors the accuracy of Medicare fee-for-service claims. Organizations may use this information to assess potential high-risk locations and then perform a risk analysis to assure healthcare compliance.

Furthermore, the Department of Justice provides a comprehensive guide on evaluating compliance programs. Although the purpose of this document is to help federal prosecutors assess whether a company’s compliance program is adequate, that guidance is also a valuable tool for companies seeking to enhance their compliance programs.

Organizations must also conduct audits, risk assessments, and monitoring to verify compliance. These activities identify and convey operational and financial risk throughout the company in real-time.

Audits help ensure that employees adhere to established policies and procedures. Organizations may opt to conduct a large-scale audit yearly or perform smaller audits on a quarterly basis. Quarterly audits drive a compliance culture with consistent visibility.

When an auditor discovers that an employee or department is not compliant, the auditor should document how to correct the situation. If someone consistently fails to comply, that person may suffer interim suspension or firing. This applies to everyone in the company, from the top down. No one should be allowed to avoid punishment for non-compliance.

Healthcare compliance software can help manage these activities. Specialized tools and templates guide the processes. Responsibility for tasks can be managed with workflow features. Documentation of all these activities can be stored within the software for an easy-to-follow audit trail.

Ensure Compliance With ZenGRC

Your customers and patients depend on you to keep their medical information confidential and safe. HIPAA compliance helps to guarantee that their trust is firmly placed. Many healthcare professionals, however, fail to live up to that promise.

Instead of using spreadsheets to manage your compliance requirements, use ZenGRC’s compliance, risk management, and governance platform to streamline evidence and audit management for all of your compliance frameworks.

ZenGRC is a compliance, risk management, and governance software designed expressly to fulfill the compliance requirements of an ever-changing market. This specialized platform alerts you to changes in laws and enables you to monitor non-compliance risks in real-time.

It is a single source of truth that ensures your organization is always audit-ready. Policies and procedures are revision-controlled and easy to find in the document repository. Workflow management features offer easy tracking, automated reminders, and audit trails. Insightful reporting and dashboards provide visibility to gaps and high-risk areas.

Several templates are tailored to various high-impact national and international standards, including frameworks for HIPAA, CCPA, GDPR, ISO, and many others. Cross-mapping common requirements across multiple compliance frameworks simplifies evidence collection and reduces the workload on your team.

Schedule a demo today and start in the hassle-free compliance, the Zen way!

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