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DEA to ease burden, allow e-prescribing controlled substances

From the June ACP Internist, copyright 2010 by the American College of Physicians

By Neil Kirschner, PhD

Despite multiple articles within the literature regarding the many benefits of electronic prescribing (eRx), and the 2009 implementation of an eRx incentive program within Medicare, only a limited number of physician practices employ this technology. A recent study by Surescripts, available online, estimated that by the end of 2009 only 25% of all office-based prescribers were using eRx.

One roadblock to more complete implementation has been the Drug Enforcement Administration’s (DEA) prohibition against the electronic transmission of prescriptions for controlled substances, thus requiring the burden of separate workflows for prescriptions for controlled and non-controlled substances. On March 31, the DEA released an interim final rule that will effectively remove this limitation.

Q: Why were controlled substances prohibited from being electronically transmitted up to now?

A: The DEA believed that controlled substances carried a much higher risk of diversion and there was a need for increased safeguards to prevent misuse and abuse in comparison to non-controlled medications. This increased risk relates to the addictive nature of these drugs and the high prices they can command on the illegal market. The DEA wanted to develop and implement a more secure process for prescribing these substances before allowing electronic transmission of prescriptions.

Q: Is this the first time the DEA has attempted to address this issue?

A: No. The DEA released a proposed rule addressing this issue in June 2008. The procedures defined in that rule were viewed as too burdensome and inflexible by most stakeholders, including the College. The current interim rule, while effectively addressing the diversion issue and facilitating the prosecution of violators, is more responsive to physician burden and workflow issues than the original proposed rule.

Q: When does the new rule take effect?

A: June 1. Since this rule is an interim final rule that also requests further comments from multiple stakeholders, it is likely that there will be further modifications later in the year. In addition, certain changes need to be made within the current e-prescribing operating standards before “real world” implementation of the rule. This process will likely take at least several months past the effective date of the rule. ACP will notify members when this process is completed on our eRx website.

Q: Is it mandatory to begin electronically transmitting controlled substance prescriptions after the rule is operational?

A: No. This rule only provides an option for providers to use eRx for controlled substances. Physicians can still choose to write and manually sign prescriptions, or alternate as necessary between manually writing or electronically transmitting them.

Q: Can I use my current eRx system to transmit controlled substance prescriptions?

A: An eRx system, whether free-standing or part of an electronic health record (EHR), must comply with a set of requirements specified in the rule. It is the responsibility of the application provider, your vendor, to hire a qualified third party or approved certification body to audit the system and issue a report on whether the system meets DEA requirements. You will need to contact your vendor to determine if your system meets DEA requirements.

Q: Do I need any special credentials in addition to my DEA number to engage in eRx of controlled substances?

A: Yes, “identity proofing” is part of the DEA’s safeguard procedures. Individual physicians will be required to apply to entities that serve as federal approved credential service providers (CSPs) or certification authorities (CAs) to verify their identity and obtain the necessary credentials to engage in the eRx of controlled substances. These private organizations already conduct identity proofing and issue identity credentials as part of their existing businesses. Contact your eRx vendor to obtain a list of the approved entities in your area. This process can be done in person or through a remote process. Institutional physicians will have the option to conduct in-person identity proofing in-house.

Q: What are the additional security steps required to transmit a controlled substance eRx?

A: The DEA is requiring a “two-factor” credential for a physician to approve and sign a controlled substance eRx. A DEA-approved eRx system must allow you to use two of the following to approve and sign a controlled substance prescription: something you know (e.g., a password), something you have (e.g., a hard token such as a smart card that is stored separately from the computer), and something you are (e.g., biometric information such as a thumb print). In addition, a person in the practice other than the physician must be responsible for checking that the physician has valid credentials to practice medicine, prescribe controlled substances, and electronically prescribe them. Once the physician’s credentials are validated, this second person sets the eRx system controls of the practice to allow the physician system access. This is a one-time process called a “logical access control” requirement.

Q: Where can I obtain additional information regarding the eRx of controlled substances?

A: The DEA provides helpful material regarding this rule on its Web site. In addition, the College provides useful information regarding the general topic of eRx, including the eRx of controlled substances, online.

Neil Kirschner, PhD, is Senior Associate, Regulatory and Insurer Affairs for the American College of Physicians.

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