The interim final rule to permit electronic prescriptions for controlled substances requires an indication that a prescription has been digitally signed, but it will take time to modify the e-prescribing transaction to add the new field.

Until then, alternative interim solutions exist and should be used, according to Emdeon Business Services, a vendor of claims clearinghouse and revenue cycle management software and services. The Nashville, Tenn.-based company recently submitted comments on the rule to the Drug Enforcement Administration within the Department of Justice.

"An interim solution is being built for the current regulated National Council for Prescription Drug Programs SCRIPT version 8.1 to denote the prescription was signed," Emdeon's comment letter notes. "An interim solution is also being built (which may be the same) for SCRIPT version 10.6 which is going through the HHS regulatory process. A longer-term solution is also being analyzed for a future version of SCRIPT. Anytime significant modifications are required to a standard that has been named in regulation (e.g. NCPDP SCRIPT) the regulatory process must be invoked, which adds delays to the implementation timeframe for the industry."

Emdeon supports an alternative interim solution for the digital signature by placing the signature indicator inside an XML "envelope" or "wrapper" in the header of the prescription, the company notes. "This wrapper also includes other information to identify new prescriptions as controlled substances for the participating pharmacies. This wrapper meets the rule by including a field indicating that a prescription has been signed."

All stakeholders understand that time will be needed to develop and approve a permanent field in the SCRIPT standard to accommodate the digital signature indicator, according to the letter. "We recommend that DEA work with the industry representative groups to establish interim implementation guidelines which may allow for adoption variances while long term infrastructure is developed and implemented to meet the minimum requirements of the interim final rule."

The company also provides recommendations in such areas as archiving, content alteration, eligibility verification and two-factor authentication. The comment letter is available at Click on Emdeon DEA Response Letter.

--Joseph Goedert


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