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

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

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

CONTENTS • Overview • EPCS Process • Who Must Comply? • 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: • Every physician and pharmacy

application vendors

• Apply for the eligibility to conduct EPCS

COMPLIANCE

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Application service providers: • Must have a certification • Third-party audit • 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)

• 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

• Identification of the DEA requirements that are achieved

• 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

• Deliverable includes: – An independent report regarding compliance – Summary of the applicable compliance

benchmarks – 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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