Top Ten Essentials for Preventing Hospital Controlled Substance Diversion

Former late night comedy institution David Letterman introduced his long-running, ever popular, Top Ten List* on Late Night with David Letterman on September 18, 1985.  Drug Enforcement Administration (“DEA”) registrants, primarily hospitals/healthcare systems and pharmacies, have resolved alleged recordkeeping, reporting and security violations of the Controlled Substances Act and DEA regulations over the years by agreeing to pay civil penalties.  Internal employee diversion was an important factor in some of those settlements.  High profile settlements have resulted in civil penalties in millions of dollars and burdensome remedial programs as cost of continued operations.

Civil settlements since 2018 include:

• University of Michigan Health System payment of $4,300,000 and compliance with 3-year Memorandum of Agreement (“MOA”);
• McLaren Health Care Corporation payment of $7,750,000 and compliance with 3-year MOA;
• Sovah Health payment of $4,360,000 and compliance with 4-year Non-Prosecution Agreement (“NPA”);
• Pikeville Medical Center payment of $4,394,600 and compliance with 3-year MOA;
• Cheshire Medical Center payment of $2,000,000 and compliance with corrective action plan;
• Lehigh Valley Hospital Network payment of $2,750,000;
• Sutter Valley Hospitals (dba Sutter Medical Center Sacramento and Sutter Fairfield Surgery Center) payment of $3,200,000; and
• West Virginia United Health System payment of $4,177,139 and compliance with 3-year MOA.

With apologies to Mr. Letterman, 41 years after kicking off his classic Top Ten Lists, we present the less funny “Top Ten Essentials for Preventing Hospital/Healthcare System Controlled Substance Diversion:”

Number 10. Hire and train adequate staff; do not cut corners.

Number 9. Trusted employees are also capable of bad behavior so provide adequate oversight of
every employee who orders and handles controlled substances.  Be wary of
employees who volunteer for controlled substance responsibilities beyond their job
description.

Number 8. Create, maintain and adhere to controlled substance policies and procedures that are
compliant, comprehensive and current.

Number 7. Conduct periodic mock DEA-style controlled substance accountability audits and
record, report and security reviews.

Number 6. Deploy advanced technology and software to track and monitor controlled
substances that identify irregularities and discrepancies.

Number 5. Select and incorporate MOA and NPA elements from high profile civil settlements
into your compliance program.

Number 4. Invest in compliance early in your operations or pay and invest later.

Number 3. Commit to comply with all federal, state and local controlled substance laws and
regulations from the beginning.

Number 2. Accountability, accountability, accountability.  The underlying purpose of controlled
substance recordkeeping, reporting and security requirements is for accountability.

Number 1. Noncompliance with your controlled substance obligations puts patients,’
employees,’ and the public’s health at risk.

*Incidentally, The Number One word of Late Night’s first Top Ten List, “The Top Ten Words That Almost Rhyme with Peas,” was “meats.”