Copyright 2019 Compliance Today Magazine, a publication of the Health Care Compliance Association (HCCA). All rights reserved. This article may not be reproduced in any form without the express written permission of the publisher.
The opioid epidemic is one of the top enforcement priorities for the U.S. Department of Justice (DOJ). In October 2018, former Attorney General Jeff Sessions referred to the opioid epidemic as the “deadliest drug crisis in American history” when he announced DOJ’s plan to counter the issue through increased enforcement of the country’s drug laws. If recent history is a guide, hospitals may soon find themselves in the government’s crosshairs, as the Controlled Substances Act (CSA) provides for civil penalties for drug division and other recordkeeping violations, and is proving to be a powerful tool in the government’s arsenal.
The Controlled Substances Act
In recent years, the government has increased its civil enforcement efforts against hospitals and health systems for violations of the CSA, often in record-breaking amounts. This article provides an overview of the CSA, examines recent enforcement actions, and offers suggestions on how to mitigate opioid diversion and enforcement risks.
General Structure of the CSA
The CSA is the main federal statute that regulates the lawful production, possession, use, distribution, and importation of certain controlled substances. In general, the CSA establishes a scheduling system in which controlled substances are placed into five categories based on medical use, potential for abuse, and safety or dependence liability. The CSA further states that any individual or entity that handles controlled substances must register with the Drug Enforcement Administration (DEA). Each registrant is subject to detailed recordkeeping, security, and reporting requirements. The purpose of the CSA is to create a “closed system” of distribution, which helps to “ensure that all controlled substances are accounted for from their creation until their dispensing or destruction” and to minimize the possibilities of diversion.
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