EPCS

What is EPCS and Why Does it Matter?

Electronic Prescribing for Controlled Substances (EPCS) is a DEA requirement that allows healthcare providers to prescribe controlled substances electronically. EPCS aims to address drug diversion, abuse, and misuse while improving efficiency in healthcare operations.

The Drug Enforcement Administration (DEA) has implemented strict rules and guidelines for EPCS systems to ensure secure, accurate, and compliant prescribing practices. For healthcare providers, pharmacies and vendors, adhering to these rules is critical for certification and recertification.

This blog will provide insights into the DEA requirements, why certification is necessary, and what organizations need to know to remain compliant.

DEA Requirements for EPCS

The DEA’s Final Rule for EPCS, published in Title 21 CFR Parts 1300, 1304, 1306, and 1311, outlines the legal framework for electronically prescribing controlled substances. The rule ensures that healthcare organizations implement necessary security measures to prevent unauthorized access, abuse, or diversion of Controlled substances.

Key requirements include:

Identity Proofing

Practitioners must undergo identity proofing to obtain their credentials before being authorized to use an EPCS system.

Individual Practitioners are required to undergo identity proofing by a certified accountant (CA) or a certified public accountant (CPA). At the same time, Institutional Practitioners are identity-proofed by the Institution, typically the Credentialing Department of the hospital. Due to Covid, the DEA further explained that remote identity proofing is allowed.

Two-Factor Authentication (2FA)

EPCS systems must require two-factor authentication for all prescribers when signing prescriptions. The DEA mandates the use of at least two of the following authentication factors:

It is essential to note that the DEA does not specify the type of biometrics that can be used for EPCS, only that they must be approved for EPCS by an independent organization.

Additionally, tokens must be compliant with FIPS 140-2, Security Level 1.

Systematic Certification

EPCS software must be certified by a DEA-approved third-party auditor or a qualified certification organization. The certification ensures that the software complies with all security requirements.

Vendors must provide proof of compliance to customers using their software.

Audit Trails

EPCS systems must maintain a detailed audit trail of prescription activity, logical access changes, and interference with the application or auditing. This ensures accountability and helps detect any unauthorized or suspicious behavior.

Data Integrity and Security

System access must be tightly controlled to limit unauthorized entry.

Recordkeeping

Records must be kept for a minimum of two years from the date of creation or receipt.

EPCS systems must maintain tamper-evident records and ensure they are secure from unauthorized access or modification.

Systems must generate and retain an accurate log of all activities, including prescription creation, signing, and transmission.

The DEA Certification Process for Hospitals

For hospitals, the selection and use of EPCS systems involve a series of rigorous steps to ensure compliance.

Select a DEA-Compliant EPCS Solution

Confirm that the systems integrate identity proofing, multi-factor authentication, audit trail, and recordkeeping capabilities.

Identity Proofing for Prescribers

The organization must initiate identity proofing for all prescribers using the EPCS application

Each prescriber will receive secure credentials to access the EPCS system.

Configure Two-factor Authentication (2FA)

Ensure that prescribers are enrolled in two-factor authentication. The system must support at least two of the following: password or pin, hardware or software token, or biometric data.

Training and Onboarding

Train prescribers and other staff on how to use the EPCS systems securely. Security awareness and training regarding identity and authentication, credential stealing, and safe data handling. Continue to maintain an internal audit trail for monitoring threats and detecting fraud. Ensure practitioners review their CS Rx reports for any anomalies. Implement a process for monitoring the EPCS system to ensure ongoing compliance.

The Importance of Certification and Recertification

Certification is essential for any EPCS software or system to ensure compliance with DEA requirements. Without proper certification, healthcare providers cannot legally use electronic systems to prescribe controlled substances.

Certification Process

Third-Party Audits: A DEA-approved auditor assesses the EPCS software for compliance with DEA rules.

Documentation Review: Auditors analyze the system’s design, security features, and implementation to ensure alignment with DEA standards.

Report and Approval: The auditor generates a report confirming compliance, and the software is certified for use.

Recertification: Why it Matters

EPCS compliance is not a one-time effort. Vendors and organizations must ensure that their systems remain compliant as regulations and technology evolve. Recertification is required every two years or if changes to system functionality impact DEA compliance standards.

How Does EPCS Benefit Healthcare Organizations and Patients?

EPCS provides significant advantages for both healthcare providers and patients:

Reduces Prescription fraud and abuse by eliminating paper prescriptions, EPCS minimizes the risk of theft, forgery, and tampering.

Enhances Efficiency: EPCS streamlines prescription workflows, saving time for both prescribers and pharmacists.

Improvement in Patient Safety: By enabling electronic tracking, EPCS ensures accurate prescriptions, reducing medication errors.

Ensures Compliance: Certified systems meet DEA standards, mitigating legal and regulatory risks.