DEA Announces Major Change to Registration Renewal DEA Announces Major Change to Registration Renewal

DEA Announces Major Change to Registration Renewal

Physicians and other health care providers who prescribe controlled substances need to be aware of a change in how the Drug Enforcement Agency (“DEA”) handles renewals. To prescribe controlled substances, health care providers such as physicians need to be registered with the DEA. The DEA is responsible for ensuring that all controlled substance transactions take place within the “closed system” of distribution established by Congress. Under this closed system, all legitimate handlers of controlled substances – manufacturers, distributors, physicians, pharmacies, and researchers – must be registered with the DEA and maintain strict accounting for all distributions.

In the past, registrants who failed to timely renew their registration did not have their registration automatically retired or revoked. Instead, the DEA had an unofficial practice of permitting registrants a “grace period” to submit their renewal applications late.

Starting January 1, 2017, the DEA will no longer allow a grace period for registrants who fail to file a timely renewal application. If a timely renewal application is not filed, the DEA registration will automatically be retired on the date of expiration. The DEA will only send out one renewal notification, the renewal will be sent to the registrant’s “mail to” address, and no other reminders will be provided by the DEA. A failure to file a renewal application by midnight Eastern Time of the expiration date will mean that the registrant’s DEA number will be retired. Registrants will then have to complete an application for a new DEA registration. The original DEA registration will not be reinstated.

The consequences of this change will not be known with certainty until after January. However, a physician who loses his or her DEA registration will have problems. At a minimum, prescriptions written by the physician will be invalid. If a pharmacy knows the affected physician is not registered with the DEA, the prescription will not be filled. Mistakenly filling an invalid prescription for a drug that is subsequently paid for by Medicare or Medicaid could give rise to an overpayment obligation on the part of the pharmacy. Additionally, there may be significant collateral consequences to losing DEA registration. For example, loss of DEA registration could trigger licensure problems with state medical boards and enrollment problems with Medicare, Medicaid, and other third-party payers. Affected physicians may also have trouble maintaining clinical privileges with hospitals.

As a result, physicians need to ensure they timely renew their DEA registration. Physicians should know the expiration date of their DEA registration and make sure the address on their DEA registration is correct.

The DEA notice can be found here: https://www.deadiversion.usdoj.gov/drugreg/index.html.
 
For more information about DEA registration, please contact Robert J. Cochran or the Ice Miller attorney with whom you work. 

This publication is intended for general information purposes only and does not and is not intended to constitute legal advice. The reader should consult with legal counsel to determine how laws or decisions discussed herein apply to the reader’s specific circumstances. 
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