The document outlines the Electronic Prescriptions for Controlled Substances (EPCS) process following the DEA's 2010 revisions that allow prescriptions to be issued electronically, aiming to reduce paperwork and forgery risks. It clarifies compliance requirements for practitioners and pharmacies, including the need for certification and adherence to specific DEA regulations. The document also describes audit phases to ensure compliance with the DEA requirements, with a focus on evaluating controls and areas for process improvement.

1. ©2014 BrightLine CPAs & Associates, Inc. All Rights Reserved
©2014 BrightLine CPAs & Associates, Inc. All Rights Reserved

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CONTENTS
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Overview
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EPCS Process
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Who Must Comply?
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Audit Phases
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OVERVIEW
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March 31, 2010 DEA revision to give physicians the choice of writing prescriptions for controlled substances the traditional method or through the electronic system.
OVERVIEW
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OVERVIEW
This will provide: A reduction of paperwork and
will mitigate the risk of forgery
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PROCESS
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PROCESS
Logical access controls
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PROCESS
Digital signature functionality
Logical access controls
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PROCESS
Time requirements within defined threshold of the NIST time source
Digital signature functionality
Logical access controls
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PROCESS
Audit trail of controlled substance prescriptions
Time requirements within defined threshold of the NIST time source
Digital signature functionality
Logical access controls
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PROCESS
Archiving of audit logs
Audit trail of controlled substance prescriptions
Time requirements within defined threshold of the NIST time source
Digital signature functionality
Logical access controls
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PROCESS
Physical security and processing integrity controls
Archiving of audit logs
Audit trail of controlled substance prescriptions
Time requirements within defined threshold of the NIST time source
Digital signature functionality
Logical access controls
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WHO MUST COMPLY?
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Not a mandate to implement EPCS
(Except New York)
COMPLIANCE
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Practitioners / pharmacies that perform EPCS
(Compliance with the DEA rule)
COMPLIANCE
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Surescripts mandates:
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Every physician and pharmacy application vendors
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Apply for the eligibility to conduct EPCS
COMPLIANCE
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Application service providers:
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Must have a certification
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Third-party audit
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Ensure that every electronic prescription and pharmacy application can be used to sign, transmit, or process controlled substances.
ADDITIONAL DOCUMENTATION REQUIREMENTS
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Practitioners must be in compliance (Section 1311.120)
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Pharmacy applications must be in compliance (Section 1311.205)
COMPLIANCE
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AUDIT PHASES
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Evaluation of controls to meet the DEA requirement
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Identification of the DEA requirements that are achieved
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Identification of the DEA requirements that are not in place to ensure compliance
PRELIMINARY ASSESSMENT
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Determine the EPCS application’s compliance with the DEA requirements
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Deliverable includes:
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An independent report regarding compliance
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Summary of the applicable compliance benchmarks
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Summary of process improvement areas
FINAL ASSESSMENT
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SUMMARY
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Demonstrate design and operational effectiveness
BENEFITS OF THE AUDIT
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Demonstrate design and operational effectiveness
Meet regulatory or contractual mandates
BENEFITS OF THE AUDIT
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Demonstrate design and operational effectiveness
Meet regulatory or contractual mandates
Bolster trust and confidence
BENEFITS OF THE AUDIT
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Demonstrate design and operational effectiveness
Meet regulatory or contractual mandates
Bolster trust and confidence
Independent and validated third party opinion
BENEFITS OF THE AUDIT
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Demonstrate design and operational effectiveness
Meet regulatory or contractual mandates
Bolster trust and confidence
Independent and validated third party opinion
Demonstrates management’s responsibility and accountability
BENEFITS OF THE AUDIT
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Demonstrate design and operational effectiveness
Meet regulatory or contractual mandates
Bolster trust and confidence
Independent and validated third party opinion
Demonstrates management’s responsibility and accountability
Promote a stronger control environment
BENEFITS OF THE AUDIT
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LEARN MORE >>
Want to know more about EPCS?
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