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Healthcare Compliance Assessments

EPCS-DEA Third Party Audits

Schellman can not only help you effectively communicate your compliance to your stakeholders, but also satisfy regulatory requirements as well.

Contact a Specialist Build Your Compliance Roadmap

EPCS-DEA Middle

Why EPCS-DEA Compliance?

Electronic Prescriptions for Controlled Substances (EPCS) regulations state, before any electronic prescription or pharmacy application may be used to transmit prescriptions, a third party must audit the application for compliance with the requirements of 21 CFR part 1311, or a certifying organization whose certification process has been approved by DEA must verify and certify that the application meets the requirements of 21 CFR part 1311.

EPCS-DEA Middle

Our Process

We begin each project with your end goals in mind and to provide preparation for future key project activities. Effective communication and timely coordination of project planning activities are central to our methodology with our clients.

Schellman will provide you with a team of exclusively certified information systems auditors with experience in conducting 1000s of independent third party audits. We have refined process to effectively evaluate the security, processing integrity and compliance of EPCS applications.

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Planning

After the agreement is executed, the first phase of the engagement is planning. This is to ensure that Schellman and the Client are fully aware of the what, who, when, why, and how prior to the beginning of testing.

Proper planning is imperative to the success of a project. Schellman has standard processes to cover the important pieces of the engagement.

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Understanding and Kickoff

The kickoff is considered the start of the engagement. If needed, Schellman will schedule a call at the beginning of, or just prior to, the kickoff to finalize any outstanding items. Schellman will be available to the client with any questions.

By including communication prior to starting, Schellman ensures that no last-minute changes to the project or team have occurred and the Client has the plan prior to the testing and on-site visit.

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Testing and Gathering

Testing and gathering is the core of the compliance engagement. Due to the planning and understanding processes, this phase will be an accumulation of gathering the evidence needed for the objectives discussed.

Schellman has a no surprise policy and has daily contact with the stakeholders during the testing and gathering activities. Furthermore, Schellman will begin documentation of the draft deliverable to be able to provide it to the Client efficiently after this phase. The Client will have confidence the Schellman team has completed this phase timely and completely.

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Reporting

Schellman’s testing methodology ends with reporting, but the entire assessment is focused on creating a deliverable that is clear, concise, and accurate.

Schellman’s report takes into account the entire process and customizes a report for each Client. The draft report will be provided within 2 weeks of the last day of testing and gathering phase, and a final report will be provided within 30 days. This timing is unsurpassed by the industry.

Contact a Specialist

Gary Nelson

Gary Nelson is a Principal at Schellman. Gary currently helps lead Schellman’s HITRUST and DEA EPCS practices and has been a leading expert of both HITRUST for healthcare service organizations and DEA EPCS for providers of electronic prescription and electronic pharmacy applications.

Meet Gary Contact Us

  • Fixed-Fee Using an outcome-based, fixed-fee pricing model based on our extensive experience
  • Scope Creep We see less than 5% of our clients that see amendments and are often the result of a scope expansion
  • Low Overhead Low overhead means a flexible financial structure

Learn more about our pricing process

Learn more about our pricing process

How much will your audit cost?

Whether it is an ISO 27001 certification, SOC 2 examination or a FedRAMP assessment, companies are often challenged by the need to address customer requirements while ensuring a return on compliance investment.

The most important factor in scoping a potential assessment is understanding what deliverable the recipient (i.e. your customer or partner) is expecting.

Once we have scoped your environment and needs, there are several factors that contribute to Schellman’s pricing:

  • Fixed-Fee Using an outcome-based, fixed-fee pricing model based on our extensive experience
  • Scope Creep We see less than 5% of our clients that see amendments and are often the result of a scope expansion
  • Low Overhead Low overhead means a flexible financial structure

Learn more about our pricing process

Learn more about our pricing process

Contact Us

Fill out this form to talk with one of our specialists. We'll be in touch soon to continue the conversation and help you find what you're looking for.

Contact Us

Fill out this form to talk with one of our specialists. We'll be in touch soon to continue the conversation and help you find what you're looking for.

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Outside the U.S.
1.813.288.8833

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“Schellman” is the brand name under which Schellman & Company, LLC and Schellman Compliance, LLC provide professional services. Schellman & Company, LLC and Schellman Compliance, LLC practice as an alternative practice structure in accordance with the AICPA Code of Professional Conduct and applicable law, regulations and professional standards. Schellman & Company, LLC is a licensed certified public accounting firm (Florida license number AD62941) registered with the Public Company Accounting Oversight Board (PCAOB) that provides attest services to its clients, and Schellman Compliance, LLC provides nonattest cybersecurity and compliance professional services to its clients. Schellman Compliance, LLC is not a licensed CPA firm. Schellman & Company, LLC and Schellman Compliance, LLC are independently owned and are not liable for the services provided by any other entity providing services under the Schellman brand. Our use of the terms “our firm” and “we” and “us” and terms of similar import, denote the alternative practice structure conducted by Schellman & Company, LLC and Schellman Compliance, LLC.