Record settlement reached in University of Michigan hospital drug diversion civil penalty case
DETROIT - The Drug Enforcement Administration and United States Attorney’s Office for the Eastern District of Michigan today announced that the University of Michigan Health System has agreed to pay the United States $4.3 million as part of a settlement resolving allegations that UMHS violated certain provisions of the Controlled Substances Act, 21 U.S.C. §§ 801-904. The settlement, which is civil in nature, resulted from a years-long Drug Enforcement Administration investigation of UMHS’s handling of controlled substances. It is the nation’s largest settlement of its kind involving allegations of drug diversion at a hospital.
DEA began its investigation after two tragic incidents occurred in December 2013 involving two UMHS employees – a nurse and an anesthesiology resident. Both overdosed on opioids, including fentanyl, at a UMHS facility. The nurse’s overdose was fatal.
Following its investigation, DEA concluded that a number of the hospital’s practices concerning controlled substances were in violation of the CSA. For example, UMHS failed to secure DEA registrations for 15 off-site ambulatory care locations throughout Ann Arbor and Southeast Michigan, each of which received narcotics from the main hospital’s pharmacy and dispensed them to patients. The failure to secure DEA registrations rendered unlawful all of the narcotics distributions from the main hospital to the unregistered off-site locations, as well as the unregistered locations’ subsequent dispensing of these narcotics to their patients.
DEA also determined that UMHS committed a number of significant recordkeeping violations, some of which included failing to maintain complete and accurate records of certain controlled substances that it received, sold, delivered or otherwise disposed of, and failing to notify DEA in a timely manner regarding certain instances of thefts or significant losses of controlled substances. DEA concluded that UMHS’ deficient recordkeeping negatively impacted UMHS’ ability to guard against the theft and diversion of controlled substances.
"Through rigorous investigation, DEA Diversion Investigators uncovered system-wide violations within the University of Michigan Health System, highlighting the fact that anything short of full compliance can have grave public health consequences" said DEA Special Agent in Charge Timothy Plancon. "This case should alert all health systems – large or small – that complying with the Controlled Substance Act is not only their legal responsibility but also a matter of public trust."
"Every professional and every institution throughout our health care system has a responsibility to comply with the laws governing the regulation of controlled substances," said United States Attorney Matthew Schneider. "Even the University of Michigan Health System, which does great work every single day, has an obligation to its patients, to its employees, and to the public to responsibly control its drug inventory."
As part of the settlement, UMHS has entered into a three-year Memorandum of Agreement with DEA, which prescribes the hospital’s drug-handling responsibilities going forward. That Memorandum also recognizes the substantial steps that UMHS has already taken to address deficiencies in its handling of controlled substances.
A main objective of the CSA is controlling illegitimate traffic in controlled substances. To prevent the diversion of controlled substances, the CSA regulates persons, companies and other entities that manufacture, distribute and dispense controlled substances. The government’s investigation and resolution of this matter illustrates the government’s emphasis on combating the prescription opioid crisis.
This matter was investigated by Diversion Investigator Brian Bishop from DEA’s Detroit Field Division and Assistant U.S. Attorneys Peter Caplan and Caroline Burgunder from the United States Attorney’s Office for the Eastern District of Michigan.
The claims resolved by the settlement are allegations only, and there has been no determination of liability.