A national provider of pharmacy services to long-term care facilities has agreed to pay the United States $2.75 million to resolve allegations that it violated federal controlled substance dispensing laws. The allegations include allowing opioids and other controlled substances to be dispensed without a valid prescription between January 1, 2014, and December 13, 2017.
The pharmacy company dispenses prescription drugs, including controlled substances, to long-term care facilities, primarily through on-site automatic dispensing units (ADUs). The pharmacy company supplied these ADUs with drugs through seven regional hubs located throughout the country. Each hub, as well as each ADU, was separately registered with the DEA as a pharmacy able to dispense controlled substances.
The Government alleges that the pharmacy company violated the federal Controlled Substances Act (CSA) in its dispensing pursuant to purported “‘emergency prescriptions.” In almost every circumstance, Schedule II controlled substances require a written prescription by a physician, and refills are not permitted by law. The CSA allows pharmacists to dispense Schedule II controlled substances, such as opioid pain medications, without a written prescription only in a true emergency situation and even then, only for the quantity of drugs necessary to treat the patient during the emergency period. Emergency prescriptions must promptly be reduced to writing and signed by an authorizing physician within seven days of issuance. Failure to meet these requirements results in an illegal dispensing of controlled substances without a valid prescription.
The Government’s investigation conducted by the Department of Justice revealed that the pharmacy company routinely abused the emergency prescription provisions of the CSA by requesting and obtaining verbal “emergency” refills from prescribers, in the absence of any true emergency. Instead, the company used these purported emergency prescriptions to effectuate simple refills of the patients’ medications. Moreover, the pharmacy company routinely failed to obtain written prescriptions within seven days after the verbal authorization. Rather than disclose these violations to the drug enforcement administration (DEA) as required by law, the pharmacy company engaged in a nationwide scheme to cover up its violations by obtaining backdated prescriptions from the prescribing physicians, in many cases over a year after the controlled substances were dispensed.
Finally, the Government resolved allegations that the pharmacy company submitted false claims to Medicare for invalid emergency prescriptions, as discussed above. The Government also resolved claims that the pharmacy company billed Medicare Part D for claims that had already been reimbursed through claims paid to long-term care facilities under Medicare Part A.
The settlement resolves a lawsuit filed in the U.S. District Court for the Northern District of Georgia by a former pharmacist at the pharmacy company under the qui tam or whistleblower provisions of the False Claims Act, which permit private citizens to bring lawsuits on behalf of the United States and obtain a portion of the government’s recovery.
Compliance Perspective
Issue
The medical director of the facility, attending physicians, and all licensed nursing staff should be knowledgeable of the controlled substances dispensing laws. Licensed staff, along with physicians who have prescribing rights at a facility, must be aware of what constitutes an emergency prescription for controlled substances. Removing medications from the emergency kit unlawfully can result in fines and criminal charges.
Discussion Points
- Review your policy and procedure for controlled substance emergency prescriptions. Update your policy and procedure if needed.
- Train medical staff and licensed nursing staff on your policy and procedure for management of controlled substance emergency prescriptions. Document that the trainings occurred, and file the signed document in each employee’s and medical staff member’s education file.
- Periodically audit to ensure that controlled substance emergency prescriptions have a corresponding written and signed prescription by an authorized physician within seven days.
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