EPCS Services: How to Comply with EPCS Regulations

E-prescribing systems allow healthcare providers to send prescriptions to pharmacies electronically. They replace paper-based prescriptions and improve traceability and accuracy. 

Digital prescriptions offer many advantages, especially when healthcare providers integrate e-prescription systems into their electronic health records (EHR) systems. 

Digital e-prescribing software can:

• Prevent drug interactions by giving prescribers access to a patient’s medication history.
• Let prescribers know if the patient’s medication is covered by their medical insurance.
• Cut down on pharmacy delays so patients get their medications faster.
• Track controlled substance prescriptions to reduce prescription fraud and overprescribing.

However, e-prescribing controlled substances can be challenging for healthcare organizations. Electronic prescription systems must meet stringent standards outlined in Electronic Prescribing for Controlled Substances (EPCS) regulations. Federal and state EPCS regulations require prescribers to prove their identity, use two-factor authentication, and sign prescriptions digitally.

In this article, we’ll look at each EPCS identity requirement in more detail, including how they impact the EPCS enrollment and prescribing experience. Then, we’ll explore how EPCS services help healthcare providers to overcome the technical challenges of EPCS compliance.

Why Do Healthcare Organizations Need EPCS?

EPCS rules were created to improve the security and tracking of prescriptions, especially for drugs with a high misuse risk, like opioids. 

At the federal level, the Drug Enforcement Administration allowed electronic prescriptions for controlled substances in 2010 with the EPCS Final Rule. The Final Rule permits practitioners to prescribe drugs in Schedules II-V digitally, but only if mandatory identity verification and security measures are in place.

Later, ECPS was made mandatory for some patients, including Medicare patients. 

Most states have also passed laws requiring EPCS for controlled substances. New York’s I-STOP Act, passed in 2015, was one of the first to mandate electronic prescribing for all prescriptions, including controlled substances. Other states, like Texas, California, and Florida have their own EPCS rules.

EPCS Requirements: The Essential Components

A DEA-compliant EPCS system must implement three identity and authentication processes compliant with NIST Digital Identity Standard 800-63: identity proofing, two-factor authentication, and digital signatures. 

Together, these technologies provide cryptographic evidence that:

• The prescriber is who they claim to be,
• They are authorized to prescribe controlled substances, 
• The prescription wasn’t altered after it was sent. 

They also prevent prescribers from later denying that they sent a prescription. 

The Drug Enforcement Administration (DEA) outlines these requirements in Title 21 of the Code of Federal Regulations (21 CFR Part 1311). 

Identity Proofing

Identity proofing is how prescribers demonstrate that they are who they claim to be. It prevents unauthorized individuals from accessing e-prescribing systems and illegally prescribing controlled substances. 

Under EPCS regulations, healthcare practitioners must undergo identity proofing before they are allowed to digitally prescribe controlled substances. 

In the past, identity proofing was a time-consuming in-person process. The candidate prescriber met with a notary and presented documents to prove their identity. Modern EPCS services complete identity proofing remotely. A Credential Service Provider (CSP) verifies candidate prescriber identities by cross-referencing financial documents with credit bureaus, banks, and other data sources for some levels, but there is also the option to scan a Driver’s License or password and compare it with live images on a mobile device on other levels. 

Digital Signatures

A digital signature confirms that an authorized prescriber created the prescription and guarantees it hasn’t been altered. Digital signatures rely on digital certificates, which include a public key and a private key.

When a prescriber digitally signs a prescription, the EPCS service creates a cryptographic hash of the prescription and encrypts it with a private key, forming the digital signature. The private key is securely stored and only accessible to the prescriber, ensuring that only they can use it to sign prescriptions.

When the pharmacy receives the prescription, they use the prescriber’s public key to decrypt the digital signature and verify the cryptographic hash. If the prescription has been altered or wasn’t signed with the correct private key, the system will flag it. The DEA’s regulations require digital signatures to comply with cryptographic standards like FIPS 140-2.

Two-Factor Authentication

Two-factor authentication (2FA) adds an additional layer of security. When signing a prescription, prescribers must verify their identity using two separate methods. Typically, they use something they know—a password or PIN—and something they have—a token or mobile app that generates a one-time code. 2FA ensures that a bad actor can’t sign a certificate even if they have one of the factors, like the password..

What Do Top EPCS Services, Such as Exostar, Bring to the Table?

Healthcare organizations face significant challenges implementing and maintaining secure EPCS systems. 

• Keeping up with evolving regulations is an ongoing process that requires dedicated resources to meet new standards and updates.
• Verifying prescribers’ credentials involves multiple steps and coordination with credentialing services.
• Systems need continuous monitoring and updates to keep them functioning properly and securely.
• Implementing secure technical features like certificate management, digital signing, and two-factor authentication is challenging for internal teams without specialist expertise.
• Healthcare IT teams struggle to balance EPCS needs with other priorities.

A third-party EPCS service can make compliance and security more manageable for healthcare providers. 

Enhanced Security

Managing security in-house is challenging due to limited resources and a lack of specialized expertise. Third-party EPCS providers oversee identity proofing, two-factor authentication, and digital signatures, ensuring they meet strict security standards and EPCS compliance rules.

Lower Administrative Burden

Compliance requires verifying identities, managing access, and maintaining records, all of which impose extensive administrative work. Using a third-party service reduces the workload, automating processes and managing compliance tasks. An EPCS service allows healthcare providers to focus resources on patient care rather than coordinating EPCS compliance.

Streamlined Integration

The best EPCS services integrate easily with EHR systems, providing an intuitive prescribing experience in software that prescribers are already familiar with. They help prescribers to learn quickly and work without disruptions. 

Cost Savings

Setting up an in-house EPCS system can be expensive. Hardware, software, compliance monitoring, and staff training consume money and time. A pre-configured solution that has already been evaluated and certified helps healthcare organizations avoid the upfront cost.

How Exostar’s EPCS Solutions Streamline EPCS Prescribing

Exostar ProviderPass is a NIST 800-63 compliant EPCS and identity management solution for the healthcare industry. ProviderPass makes it easy to comply with EPCS regulations with purpose-built identity proofing, two-factor authentication, and digital prescription signing. 

Take the first step towards seamless EPCS integration. Contact an EPCS specialist today.