Electronic Prescribing of Controlled Substances (EPCS)

Report
Electronic Prescribing of Controlled Substances
(EPCS)
Part 1 of a 3 Part Series
Chuck Klein, Ph.D.
GM/Director, Medication Management
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Agenda
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Defining EPCS
Legal Aspects of EPCS
Pharmacies
Requirements: OrderConnect
Requirements: Prescribers
Two-Factor Authentication
Identity Proofing and Credentialing
Workflow
Audit Reports
NY I-STOP Law
OrderConnect Timeline
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What is EPCS?
• EPCS—the Electronic Prescribing of Controlled Substances—
allows prescribers who use an EPCS-certified e-prescribing
application to send prescriptions for controlled substances
electronically to pharmacies.
• Although highly desired, EPCS is not mandatory, except for New
York State prescribers (effective 3/27/2015).
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Is EPCS Legal?
• Yes. On March 31, 2010, DEA's Interim Final Rule with Request for
Comment titled "Electronic Prescriptions for Controlled Substances"
[Docket No. DEA-218, RIN 1117-AA61] was published in the Federal
Register. The rule became effective June 1, 2010.
• The rule revises DEA regulations to provide practitioners with the option
of writing prescriptions for controlled substances electronically. The
regulations also permit pharmacies to receive, dispense, and archive
these electronic prescriptions. These regulations are an addition to, not
a replacement of, the existing rules. The regulations provide
pharmacies, hospitals, and practitioners with the ability to use modern
technology for controlled substance prescriptions while maintaining the
closed system of controls on controlled substances.
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So EPCS is Legal in Every State?
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State Boards of Pharmacy can enforce stricter rules than the DEA but
not less strict.
All states except Montana currently allow the electronic prescribing of
controlled substances.
Kansas and Vermont do not allow Schedule II medications to be sent
electronically.
Nurse practitioners in Texas may not send Schedule II medications
electronically.
Effective March 27, 2015, all prescribers in New York must send all
prescriptions electronically to pharmacies, including those for controlled
substances (NY-ISTOP).
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Is EPCS Mandatory?
From the DEA’s perspective the new regulations do not mandate that practitioners prescribe
controlled substances using only electronic prescriptions. Nor do they require pharmacies to
accept electronic prescriptions for controlled substances for dispensing.
Whether a practitioner or pharmacy uses electronic prescriptions for controlled substances is
voluntary from DEA’s perspective. Prescribing practitioners are still able to write, and manually
sign, prescriptions for schedule II, III, IV, and V controlled substances and pharmacies are still
able to dispense controlled substances based on those written prescriptions. Oral prescriptions
remain valid for schedule III, IV, and V controlled substances.
Electronic prescriptions for controlled substances are only allowed if the electronic prescription
and the pharmacy application meet DEA’s requirements. In addition, electronic prescriptions for
controlled substances may be subject to State laws and regulations. If State requirements are
more stringent than DEA’s regulations, the State requirements would supersede any less
stringent DEA provision.
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Will All Pharmacies Accept Electronic
Prescriptions for Controlled Substances?
Just as e-prescribing software applications (like OrderConnect) have to go
through DEA and Surescripts certifications, so, too, do pharmacy software
applications.
When OrderConnect is EPCS enabled, it will automatically know which
pharmacies can and cannot accept prescriptions for controlled substances.
It will not allow users to send prescriptions for controlled substances
electronically to pharmacies that are not authorized to receive them.
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The Pharmacy Landscape for EPCS
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What is Required for OrderConnect
to do EPCS?
ePrescribing Software Vendors:
• ePrescribing software vendors must get certified by a DEAapproved auditor.
• Increased focus and attention is on strict access control and
auditing.
• Two factor authentication is required when transmitting EPCS
prescriptions.
• Surescripts certification for EPCS is also required.
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What is Required for Prescribers
to do EPCS?
Prescribers:
• The DEA requires prescribers to go through Identity Proofing
and Issuance of Credentials.
• Specific processes are outlined by the DEA for ‘activating’
physicians to do EPCS.
• Two factor authentication is required by prescribers when
transmitting EPCS prescriptions.
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What is Two-Factor Authentication?
Two-factor authentication (2FA) adds a second level of authentication to an account
log-in. When you have to enter only your username and one password, that's
considered a single-factor authentication.
2FA requires the user to have two out of three types of credentials before being able
to access an account. The three types are:
• Something you know, such as a Personal Identification Number (PIN) or a
password.
• Something you have, such as a soft or hard token.
• Something you are, such as a biometric like a fingerprint, iris scan, or voice print.
Netsmart is choosing to use the first two and will offer both hard and soft token
options.
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Identity Proofing and Credentialing
Netsmart has partnered with Verizon who will provide identity
proofing and credentialing services. Verizon is a federally approved
Certificate Authority and a Credential Services Provider (NIST SP
800-63-1 Assurance Level 3).
Netsmart will offer, through the OrderConnect Admin Tool and
Registration Tool, the ability for providers to get identity proofed and
credentialed (via Verizon).
[More information about this will be offered in our next webinar on
January 22, 2015.]
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Setting Access Controls in
OrderConnect for EPCS
Once a prescriber has gone through identity proofing and obtained
an authentication credential he/she is eligible for EPCS access in
OrderConnect.
The OrderConnect Admin Tool will contain the access controls
needed to activate prescribers for EPCS according to strict DEA
standards. Two separate individuals will be required to grant
access for each prescriber.
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Prescriber Workflow
Prescribers will be able to order controlled substances and noncontrolled substances at the same time. OrderConnect will know
which medications require two-factor authentication on the Order
Confirmation screen.
Prescribers can apply two factor authentication once for all the
controlled substances being ordered at that time for that patient.
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Agent Workflow
Prescriber agents (eg, nurses, etc.) will be able to prepare
prescriptions for controlled substances on behalf of a prescriber.
Once prepared, the prescriptions will go into a prescriber’s queue.
Once the prescriber reviews the prescriptions and applies his/her
two factor authentication, they will be transmitted to the pharmacy.
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New Audit Reports
New audit reports will be available in OrderConnect that will allow a
prescriber to see all activities pertaining to his/her EPCS.
The DEA requires that each EPCS prescriber review his/her audit report
every week.
OrderConnect will give the ability for prescribers to look at a week’s work
of activity or any time range they wish.
It is up to each prescriber to check their report. Reports will not be
“pushed” to prescribers nor will OrderConnect track who has accessed
their reports and who has not.
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What is the New York I-STOP Law and
What Does it Have to Do with EPCS?
On March 27, 2015, electronic prescribing of non-controlled as well as
controlled substances will be required in New York State under the provisions
of the I-STOP law and subsequent regulations. Title 10 NYCRR Part 80 Rules
and Regulations on Controlled Substances authorizes a practitioner in New
York State to issue an electronic prescription for controlled substances in
Schedules II through V.
For electronic prescribing of controlled substances (EPCS), the regulations
require a facility to register their certified electronic prescribing computer
application with the New York State Department of Health, Bureau of Narcotic
Enforcement (BNE).
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OrderConnect’s Timeline for EPCS
• OrderConnect EPCS will be released for use by our New York
clients on March 16, 2015.
• Prior to its release, user documentation will be provided as well
as a recorded training webinar.
• Instructions will also be sent that will allow providers to go
through identity proofing and credentialing.
• In addition, information will be sent to our NY clients that will
allow them to register their OrderConnect with the NY Bureau of
Narcotic Enforcement.
• OrderConnect EPCS will be available for use by all other clients
by April 30, 2015.
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What Will the Additional Cost be
for EPCS?
This is still being determined.
It will be similar to other e-prescribing systems; there will be a per
prescriber setup fee and a small monthly increase in each
prescriber license.
As soon as the cost is finalized it will be announced.
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OrderConnect EPCS Webinars:
Part 2 and Part 3
Part 2: January 22, 2015
Will cover identity proofing and credentialing and access controls in
OrderConnect.
Part 3: February 19, 2015
Will cover EPCS workflow in OrderConnect for prescribers and
agents.
Invitations will be forthcoming.
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Questions?
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