The Top 5 Common DEA EPCS Compliance Mistakes Health IT Companies Make

May 11, 2023

Healthcare is a highly regulated industry, and ensuring compliance with regulations and laws is essential for any Health IT company. One of the most critical areas of compliance is the U.S. Drug Enforcement Administration Agency’s (DEA) Electronic Prescriptions for Controlled Substances (EPCS) compliance. EPCS is a complex set of regulations that Health IT companies must adhere to. To help, we have compiled a list of the top five common EPCS compliance mistakes made by Health IT companies.

Failing to Obtain EPCS Certification

One of the most common mistakes companies make is failing to obtain EPCS certification. EPCS certification is required by the DEA for any system that handles electronic prescriptions for controlled substances. Without certification, your software is non-compliant and should not be used for EPCS workflows. EPCS certification requires rigorous testing and a comprehensive review process that can take several weeks or months to complete. Health IT companies should start the certification process as soon as possible to ensure they can meet the DEA’s strict requirements.

Improper Authentication Protocols

The DEA requires that covered entities use at least two separate authentication factors to verify a prescriber’s identity before allowing them to prescribe a controlled substance electronically. Two-factor authentication typically involves something the prescriber knows (such as a password) and something the prescriber has (such as a hardware token, smart card, or biometric identifier). Health IT companies often make mistakes in the design and implementation of their identity verification workflows, which can compromise patient safety and non-compliance with regulations.

Poor Audit Trails

Another area of EPCS compliance that is often overlooked is the requirement for accurate and detailed audit trails. An audit trail aims to track every action taken in the EPCS workflow, from the point of authentication to the dispensing of the controlled substance. The audit trail provides accountability for all parties involved in the workflow and helps to prevent fraud and abuse. Health IT companies should make sure that their EPCS systems produce comprehensive audit trails that can be easily accessed and reviewed in the event of an investigation.

Inadequate Employee Training

Compliance with EPCS requirements cannot be achieved solely through technology. Employee training is an essential part of ensuring compliance. Health IT companies should provide comprehensive training to employees who will be involved in EPCS workflows to ensure they understand the requirements, policies, and procedures associated with EPCS compliance. Employee training should cover topics such as identity verification, audit trails, security protocols, and reporting requirements. Compliance training should be ongoing and periodically updated to reflect changes in regulations.

Inadequate Testing and Monitoring

Testing and monitoring are essential components of any EPCS system. Covered entities companies must conduct thorough testing of their systems to ensure they meet requirements and can operate correctly in real-world scenarios. Testing should include all aspects of the EPCS workflow, including identity verification, authentication, audit trails, and reporting. After the system is deployed, companies should perform ongoing monitoring to detect and correct any issues that may arise. Monitoring includes the review of audit trails and system logs to identify any suspicious behavior or errors in the system.

EPCS compliance is critical for Health IT companies that provide EPCS software solutions. It is essential to avoid the common mistakes. By following best practices, Health IT companies not only ensure compliance but also improve patient safety and prevent fraud and abuse.

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