Incident 33920

McLaren Heath Care has entered into a Settlement Agreement and Memorandum of Agreement with the Drug Enforcement Administration (DEA) and the United States Attorney’s Offices for the Eastern and Western Districts of Michigan to settle concerns relating primarily to retail pharmacy operations at some McLaren facilities.

The Agreement is the culmination of a multi-year effort with the DEA, which identified prescribing irregularities at the McLaren Port Huron retail pharmacy in 2018, prompting McLaren to terminate a pharmacist who was diverting opioids for his own personal use. A subsequent review included an exhaustive assessment of pharmacy protocols at other McLaren facilities — in some cases stretching over periods of up to 12 years. At the conclusion of its review, the DEA identified irregularities associated with recordkeeping, dispensing and distribution of controlled substances, particularly among retail pharmacies operating under “legacy” pharmacy protocols that had been in place prior to McLaren’s acquisition of their operations.

In 2018, and unrelated to this matter, McLaren exited the retail pharmacy business, including the retail pharmacies that were the subject of this investigation.

The Settlement Agreement acknowledges that prior to reaching this resolution with the DEA, McLaren had voluntarily “invested significant resources toward and made substantial improvements to its oversight and processes regarding its handling of controlled substances.”

As part of the three-year agreement, the system agrees to pay a monetary settlement and to continue the extensive actions and protocols it has established in recent years to ensure compliance with pharmacy regulations and prevent similar situations in the future, including:

• formation of a multi-disciplinary Controlled Substance Oversight Committee, which has developed a system-wide drug diversion policy that replaced all subsidiary-specific and legacy policies;
• mandatory training for approximately 10,000 employees who have regular access to controlled substances;
• creation of hospital-based teams and task forces to monitor compliance with relevant drug protocols, investigate possible diversion and provide ongoing education and training;
• retention of an outside pharmacy management company to manage and operate its inpatient pharmacies; and
• ongoing early detection measures (both electronic and “hands on” measures) to ensure discovery of possible diversion activities.

“Our health system takes compliance very seriously and regrets any instance in which we do not meet our regulators’ requirements or our own high standards,” said April Rudoni, Interim Compliance Director and Chair of McLaren’s Controlled Substance Oversight Committee. “From the moment the DEA’s first concern was brought to our attention we have worked diligently to strengthen protocols across our system. I am proud of the culture of accountability and compliance we maintain and look forward to continued collaboration with the DEA moving forward.”

A former Marysville pharmacist was formally charged in 2018 with defrauding a hospital to illegally obtain more than 200,000 doses of prescription pills, mostly opioids.

Kyle Wilhelm, 40, was arraigned Wednesday in U.S. District Court and charged with fraudulently obtaining controlled substances, which is punishable by up to eight years in prison and a fine up to $250,000, according to U.S. Attorneys.

According to an indictment, Wilhelm used his position as pharmacy manager at a hospital to obtain more than $25,000 worth of controlled substances over three years, from February 2015 to February 2018. The substances included oxycodone, hydromorphone, hydrocodone and acetaminophen, U.S. Attorneys say in a news release. A published report says he managed McLaren Pharmacies in Yale and Port Huron.

“Wilhelm exploited his knowledge of his employer’s internal controls to obtain controlled substances, which would go unnoticed during audits,” the release says.

Wilhelm created fake patients using false birth dates and addresses, and improperly used a medical doctor’s Drug Enforcement Administration registration number, the release says.

Wilhelm’s pharmacy license was suspended in March 2018, according to state records.

The case was investigated by the DEA’s tactical diversion squad and is being prosecuted by Assistant U.S. Attorney Philip A. Ross.