On March 4, 2009, the U.S. Attorney’s Office reached a civil settlement with Warren L. Moody III, M.D., an internist practicing in Phoenix. The United States contended that between June 2006 and April 2007, Dr. Moody ordered almost 3000 dosage units of Suboxone (buprenorphine) , an opiod pain relief medication. Suboxone is a prescription medication specifically designed to ease detox from opiates like heroin, OxyContin, Vicodin and Percocet.
According to the settlement agreement, Dr. Moody ordered the medication without proper documentation, failed to maintain accurate inventory records for the receipt and dispensation of the Suboxone, and failed to maintain physical security of the controlled substances, in violation of the Controlled Substances Act. Dr. Moody agreed to pay $80,000 in penalties to settle the matter. The investigation leading to the settlement was conducted by the Diversion Investigation Unit of the Drug Enforcement Administration. See
Commentary: The DEA has gotten quite aggressive in conducting periodic site inspections of its registrants which are authorized under 21 U.S.C. 822(f). This case is somewhat different in that it was not about the usual prescription medications but a narcotic that is used to treat those addicted to OxyContin, Vicodin and Percocet. Dr. Moody appears to have been a physician who was providing addicted patients Suboxone treatment in an outpatient setting. Suboxone is used as part of a complete treatment plan that can include behavioral therapy, support groups, and individual counseling.
As a review, here is a brief summary of the recordkeeping rules. A registered practitioner is not required to keep records of controlled substances that are prescribed in the lawful course of professional practice, unless such substances are prescribed in the course of maintenance or detoxification treatment. Thus, most practitioners will not be required to keep these records separately from the patient file. If your practice is involved in pain management or detox treatment, a compliance plan and periodic review are necessary to ensure your office is complying with the rules and regulations.
A registered practitioner is required to keep records of controlled substances that are dispensed to the patient, other than by prescribing or administering, in the lawful course of professional practice. In such cases, each practitioner must maintain inventories and records of controlled substances listed in schedule II separately from all other records maintained by the registrant. This must be done by retrievable by individual registrant. Likewise, inventories and records of controlled substances in schedules III, IV, and V must be maintained separately or in such a form that they are readily retrievable from the ordinary business records of the practitioner. All records related to controlled substances must be maintained and be available for inspection for a minimum of two years.
The fines and penalties can be significant if you do not comply with these rules. If there is an inspection seek legal counsel to assist in the audit and if you receive a letter requesting a response to proposed administrative action or assessing fines. The fines and administrative action can be negotiated with the U.S. Attorney's Office.
Any questions or comments should be directed to: tgreen@greenassoc.com. Tracy Green is a principal at Green and Associates in Los Angeles, California. They focus their practice on the representation of licensed professionals and businesses in civil, administrative and criminal proceedings, with a specialty in health care providers.
