Confidential1

Electronic Prescribing of Controlled Substances:

Prescriber and Agent WorkflowPart 3 of a 3 Part Series

Chuck Klein, Ph.D.GM/Director, Medication Management

Confidential2

Agenda

• Defining EPCS• Requirements: Prescribers• Workflow for Prescribers • Workflow for Agents• OrderConnect Timeline

Confidential3

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).

Confidential4

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.

Confidential5

Workflow for Prescribers

In general, the workflow for prescribers will be the same across the board with a few exceptions:• Montana and Missouri: Prescribers cannot electronically

prescribe any controlled substances• Kansas and Vermont: Prescribers cannot electronically

prescribe Schedule II controlled substances• Texas: Nurse practitioners cannot electronically prescribe

Schedule II controlled substances (physicians can)

Confidential6

Choosing and Creating the PrescriptionFor scheduled medications, a new field—required by the DEA—has been added called “Earliest Fill Date.”

Confidential7

Earliest Fill Date for C-II Medications13 CFR 1306.12• The authorization of refills of C-II medications is not allowed.• However, a prescriber may issue multiple prescriptions authorizing the

patient to receive a total of up to a 90-day supply of a C-II medication provided the prescriber provides written instructions on each prescription (other than the first one if the prescriber intends it to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription.

• OrderConnect will do the math with regards to issuing no more than 90 days of the medication and calculating earliest fill dates (eg, end date minus 5 days).

Confidential8

Earliest Fill Date for C-III&IV Medications

13 CFR 1306.22• No prescription for a Schedule III or IV controlled substance shall be

filled or refilled more than six months after the date on which such prescription was issued.

• No prescription for a controlled substance listed in Schedule III or IV authorized to be refilled may be refilled more than five times.

• OrderConnect will do the math with regards to issuing no more than six months of the medication and its refills and calculating earliest fill dates as needed (eg, end date minus 5 days).

Confidential9

Special Case PrescriptionsIf a prescription is written for Subutex, Suboxone, Zubsolv or their generic equivalents, the prescriber’s Narcotics Addiction DEA Number (NADEAN) must appear on the prescription. If the prescriber does not have a NEDEAN in his OrderConnect profile, he will not be able to prescribe those medications electronically. (21 CFR 1306.05(b))

Confidential10

Special Case PrescriptionsIf a prescription is written for Xyrem (aka, gamma-Hydroxybutyric acid; GHB), the prescriber must indicate on the prescription the medical need of the client for the prescription. (21 CFR 1306.05(c))

When a prescription for Xyrem is written, OrderConnect will automatically insert a text box where the prescriber will be required to enter the medical need of the medication. If it is not populated the prescription will not advance through the prescribing process.

Confidential11

Prescriber RemindersOrderConnect will gently remind prescribers of the DEA rules if they forget them.

Confidential12

Order Confirmation: Multiple DEA NumbersIf a prescriber has more than one DEA number listed he/she will be able to choose the one they want to associate with the prescription via the dropdown.

Confidential13

Order Confirmation: Individual Rx OptionsEach individual prescription will now have it’s own output options, including pharmacy selection.

Confidential14

Order Confirmation: Controlled Substances—”Ready to Sign”

For EPCS-enabled prescribers, each prescription for a controlled substance must be checked off as “Ready to Sign” before proceeding with output. CFR 1311.120b(10)

Confidential15

Order Confirmation: Controlled Substances—Signing

• A DEA required message will appear on the Order Confirmation screen when you are working with controlled substances:

“By completing the two-factor authentication protocol at this time, you are legally signing the prescription(s) and authorizing the transmission of the above information to the pharmacy for dispensing. The two-factor authentication protocol may only be completed by the practitioner whose name and DEA registration number appear above.”

Confidential16

Order Confirmation: Controlled Substances—SigningUpon clicking the “Sign” button the prescriber will be required to input her credential for authentication.

The credential will original from the prescriber’s hard or soft token. After entering the credential the prescription will be sent electronically to the pharmacy chosen.

The prescriber only has to enter the credential once and it will apply to all of the controlled substance prescriptions.

Confidential17

Special Cases

• If a prescription for a controlled substance was successfully sent electronically, it cannot be printed or resent.

• If a prescription for a controlled substance was sent electronically and failed, it can be printed and will contain the following information on it:• The fact that the prescription was originally intended to be sent

electronically• The name of the specific pharmacy to which the transmission failed• Complete date/time stamp of the failed attempt• The fact that the transmission failed

Confidential18

Special Cases

• If a prescription for a controlled substance was successfully printed it cannot be sent electronically.

• If a ‘chart copy’ of a prescription for a controlled substance is printed, it will clearly indicate that it is not a valid prescription.

Confidential19

Prescriber Agent WorkflowThe Agent will follow the same workflow as the prescriber. The main change is on the Order Confirmation screen. As usual, the Agent will choose the name of the prescriber for whom she is generating the verbal Order (and can see the DEA number of the prescriber).

Confidential20

Prescriber Agent Workflow for VOsThe Agent will not be able to choose any output; all output options will be unavailable. Also, the word “Pending” will appear. The Agent will then click the Accept button, as usual.

After clicking the Accept button, a DEA-mandated message will appear.

Confidential21

Prescriber Agent Workflow for VOsThe medication will show up on the Current Medication Profile screen and will be highlighted in yellow and say “Pending” next to it until the prescriber authenticates it and transmits it.

Confidential22

Prescriber VO Queue for Verbal Orders

A new Prescriber VO Queue will be available on the Prescribers Desktop screen, located in the same place as the current Refill Request Queue. All verbal orders for controlled substances will go into the queue. The prescriber will be required to indicate “Ready to Sign” each prescription that she approves and then authenticate and transmit per the workflow previously prescribed.

An indicator will also appear in client records indicating if the prescriber has any VOs for any clients in her queue.

The Prescriber VO Queue is currently under construction.

Confidential23

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.

Confidential24

What Will the Additional Cost be for EPCS?

• EPCS Setup for Use with a Soft Token (per prescriber): $40.00 (one-time fee)

• EPCS Setup for Use with a Hard Token (per prescriber): $50.00 (one-time fee)

• EPCS Setup for Use with both a Hard Token and Soft Token (per prescriber): $75.00 (one-time fee)

• EPCS Monthly Subscription Fee (per prescriber-in addition to their OrderConnect subscription fee): $8.00 per month (billed annually)

• If a prescriber fails online Identity Proofing and is required to complete a notarized form, an additional $50 fee will be charged.

Confidential25

Questions?