Healthcare Compliance Perspective – Hospital Drug Diversion:
Effective 11/28/2017, CMS requires surveyors to include medication storage and the securing of controlled substances on their list of observed practices when they conduct a facility’s annual survey. Many facilities fail to meet the requirements for medication storage and labeling that is spelled out on the form CMS-20089 and in the State Operations Manual under F755 Pharmacy Services. This failure can result in citations and assessed fines including Civil Monetary Penalties.
In the nation’s largest settlement of its kind involving allegations of hospital 
drug diversion, a Georgia healthcare system has agreed to pay the United States $4.1 million to resolve allegations that it failed to provide effective controls and procedures to guard against theft and loss of controlled substances, leading to a significant diversion of opioids, and failing to timely report the suspected diversion to the Drug Enforcement Administration (DEA).
The DEA launched an investigation in 2017 after receiving reports of diversion at the healthcare system. The DEA determined that tens of thousands of oxycodone 30mg tablets were unaccounted for and were believed to have been diverted over more than a four-year period, in violation of the hospital’s responsibilities under the Controlled Substances Act. The DEA also determined that the healthcare system failed to notify the DEA of the suspected diversion within the time required by federal law.
The healthcare system cooperated with the DEA’s investigation and, prior to this investigation, overhauled its pharmacy operations to help ensure that it will avoid diversions in the future. Since the investigation began, the healthcare system has worked cooperatively with the DEA and the U.S. Attorney’s Office to finalize a plan to address the identified deficiencies in the system’s handling of controlled substances and entered into an agreement with the DEA to memorialize the plan. Components of the plan include quarterly internal accountability audits and requirements to keep detailed records that track all controlled substances within the hospital.
