Express Scripts, Inc. and Express Scripts Pharmacy Services, Inc. (“ESI”) today agreed to pay the United States $ 2.75 million to resolve alleged violations under the Controlled Substances Act regarding diversion of controlled substances and use of phony DEA numbers at its mail order pharmaceutical facilities during the period 2002 through 2009. ESI is one of the largest pharmacy benefits managers in the United States. The resolution was announced by United States Attorney Zane David Memeger.

The Controlled Substances Act requires that pharmacies have security practices in place to prevent diversion of controlled substances that are subject to abuse and have significant street value. From 2002 through 2006 drug diversion occurred at several ESI mail order facilities, including facilities in Bensalem, PA and Harrisburg, PA. ESI experienced theft by employees of controlled substances, had inventory discrepancies, and failed to report in-transit losses to the DEA.

In order for a controlled substance prescription to be filled, federal regulations require that the prescriber’s actual DEA number be written on the prescription. From 2004 through 2009, ESI employees utilized invalid DEA numbers in ESI’s computerized prescription processing system in order to process certain controlled substances prescriptions at all of its mail order facilities. This practice risks filling prescriptions for drugs that were not legitimately prescribed by doctors.

As part of this settlement, ESI has developed a comprehensive Controlled Substances Security Compliance Plan that includes diversion protection measures far beyond those required by law, including improved physical security, enhanced inventories, reconciliations and audits, employee background checks, and mandatory training for employees who have contact with controlled substances. ESI executives, including the General Manager of Pharmacy Operations and the Chief Compliance Officer, will be required to certify compliance with the terms of the Plan. This Compliance Plan is intended to be a model for the mail order pharmacy industry.

In addition to the measures to protect against diversion of controlled substances, ESI will cease use of phony DEA numbers and will also set up an automated system to check the validity of prescribers’ DEA and NPI (National Physician Identifier) numbers against a national registry. This precedent-setting requirement is applicable not only to controlled substances, but to all prescriptions. ESI has further agreed to report to the government periodically the names of any prescribers who lack both a DEA and NPI number but are still writing prescriptions.

“Controlled substance diversion, which frequently leads to controlled substance abuse, is a major problem in America and companies who distribute these products are closely regulated,” said Memeger. “ESI had a problem, but they have demonstrated their commitment to good pharmacy practice by improving security at their facilities, committing themselves to further improvements, and working with the government to become an industry leader in this important effort.”

This resolution is part of the Eastern District of Pennsylvania’s Special Focus Team Health Care Initiative.

This case was handled by Assistant United States Attorneys Marilyn May, Thomas Johnson, and Auditor Allison Barnes and was investigated by DEA diversion investigators and supervisors E. Scott Doubet, Philip Reed, and Luis Carrion.

UNITED STATES ATTORNEY'S OFFICE, EASTERN DISTRICTof PENNSYLVANIA
Suite 1250, 615 Chestnut Street, Philadelphia, PA 19106
PATTY HARTMAN, Media Contact, 215-861-8525

 

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