Controlled Substances & Diversion
Controlled Substances & Diversion
Our national Controlled Substances & Diversion practice partners with Drug Enforcement Administration (DEA) registrants to proactively manage controlled substance compliance, prevent diversion, and successfully navigate government investigations and enforcement actions. Our cross-disciplinary team has extensive experience conducting internal, civil, and criminal investigations and defending clients facing allegations under the Controlled Substances Act (CSA), Food, Drug and Cosmetic Act (FD&C Act), and other federal and state drug laws. Critical areas in which we advise include:
- Proactive compliance counseling to prevent diversion, strengthen compliance programs, and prepare for inspections by regulators.
- Rapid crisis response to diversion incidents, unannounced federal or state inspections, and other urgent events.
- Risk assessments and guidance on potential risk and reporting obligations, with proportional short- and long-term strategies.
- Comprehensive but efficient internal investigations to minimize operational disruption while maintaining clear and timely communication.
- Coordination of parallel investigations or enforcement actions involving multiple federal and state regulators, including management of requests for internal documents, medical records and other personal health information.
- Due diligence and indemnification advice to assess potential controlled substances risk in mergers, acquisitions, reorganizations and financing transactions.
Our Unique Experience
We have assisted clients—including national and regional health systems; national specialty, mail-order and retail pharmacies; behavioral health centers; ambulance services; research facilities; and physician groups—with diversion investigations, timely regulatory disclosures, remediation, and long-term compliance enhancements. We routinely represent clients in investigations, enforcement actions and negotiations with federal and state agencies including Department of Justice (DOJ), DEA, Food Drug Administration (FDA), Department of Health and Human Services Office of Inspector General (HHS-OIG), state boards of pharmacy, and health departments.
- Unparalleled experience: We are trusted counsel for healthcare providers facing urgent crises involving DOJ and DEA enforcement actions, DEA and FDA unannounced inspections, and diversion incidents. We have guided numerous national and regional health systems, pharmacies and physician groups through complex criminal, civil and administrative matters with DOJ, DEA, FDA, state regulators and other agencies.
- Government insight: Many of our attorneys previously held leadership roles in DOJ, HHS-OIG and other government agencies, providing valuable insight into government strategies and enhancing our credibility with regulators.
- Proactive approach: We partner with clients to develop tailored compliance programs that detect and prevent drug diversion. We help our clients navigate complex federal and state regulations to remain compliant with the CSA, DEA and FDA regulations, state prescription drug monitoring programs (PDMPs) and other laws. We assist with policy development, risk assessment, prevention training, monitoring programs and other tools to mitigate risk
- Effective solutions: Our deep experience conducting confidential investigations in complex healthcare settings allows us to deliver reliable, cost-effective results while minimizing operational disruption.
- Strategic advice: Our attorneys regularly brief senior leadership and boards of directors on compliance and enterprise risks both proactively and in response to DOJ, DEA or other enforcement demands.
- Unmatched insight: As regulatory counsel to more than 200 healthcare companies, we bring unmatched insight into the regulatory and reimbursement landscape. We serve as operational and transactional counsel to a majority of the nation’s largest healthcare systems and specialty pharmacies.
- Due diligence: We also assist providers in healthcare transactions by conducting controlled substance due diligence and advising on indemnification strategies.
With deep experience, a successful track record, and best-in-class compliance counseling, our Controlled Substances & Diversion team partners with healthcare providers to manage evolving CSA compliance obligations and diversion risks.
Our national Controlled Substances & Diversion practice partners with Drug Enforcement Administration (DEA) registrants to proactively manage controlled substance compliance, prevent diversion, and successfully navigate government investigations and enforcement actions. Our cross-disciplinary team has extensive experience conducting internal, civil, and criminal investigations and defending clients facing allegations under the Controlled Substances Act (CSA), Food, Drug and Cosmetic Act (FD&C Act), and other federal and state drug laws. Critical areas in which we advise include:
- Proactive compliance counseling to prevent diversion, strengthen compliance programs, and prepare for inspections by regulators.
- Rapid crisis response to diversion incidents, unannounced federal or state inspections, and other urgent events.
- Risk assessments and guidance on potential risk and reporting obligations, with proportional short- and long-term strategies.
- Comprehensive but efficient internal investigations to minimize operational disruption while maintaining clear and timely communication.
- Coordination of parallel investigations or enforcement actions involving multiple federal and state regulators, including management of requests for internal documents, medical records and other personal health information.
- Due diligence and indemnification advice to assess potential controlled substances risk in mergers, acquisitions, reorganizations and financing transactions.
Our Unique Experience
We have assisted clients—including national and regional health systems; national specialty, mail-order and retail pharmacies; behavioral health centers; ambulance services; research facilities; and physician groups—with diversion investigations, timely regulatory disclosures, remediation, and long-term compliance enhancements. We routinely represent clients in investigations, enforcement actions and negotiations with federal and state agencies including Department of Justice (DOJ), DEA, Food Drug Administration (FDA), Department of Health and Human Services Office of Inspector General (HHS-OIG), state boards of pharmacy, and health departments.
- Unparalleled experience: We are trusted counsel for healthcare providers facing urgent crises involving DOJ and DEA enforcement actions, DEA and FDA unannounced inspections, and diversion incidents. We have guided numerous national and regional health systems, pharmacies and physician groups through complex criminal, civil and administrative matters with DOJ, DEA, FDA, state regulators and other agencies.
- Government insight: Many of our attorneys previously held leadership roles in DOJ, HHS-OIG and other government agencies, providing valuable insight into government strategies and enhancing our credibility with regulators.
- Proactive approach: We partner with clients to develop tailored compliance programs that detect and prevent drug diversion. We help our clients navigate complex federal and state regulations to remain compliant with the CSA, DEA and FDA regulations, state prescription drug monitoring programs (PDMPs) and other laws. We assist with policy development, risk assessment, prevention training, monitoring programs and other tools to mitigate risk
- Effective solutions: Our deep experience conducting confidential investigations in complex healthcare settings allows us to deliver reliable, cost-effective results while minimizing operational disruption.
- Strategic advice: Our attorneys regularly brief senior leadership and boards of directors on compliance and enterprise risks both proactively and in response to DOJ, DEA or other enforcement demands.
- Unmatched insight: As regulatory counsel to more than 200 healthcare companies, we bring unmatched insight into the regulatory and reimbursement landscape. We serve as operational and transactional counsel to a majority of the nation’s largest healthcare systems and specialty pharmacies.
- Due diligence: We also assist providers in healthcare transactions by conducting controlled substance due diligence and advising on indemnification strategies.
With deep experience, a successful track record, and best-in-class compliance counseling, our Controlled Substances & Diversion team partners with healthcare providers to manage evolving CSA compliance obligations and diversion risks.
Experience
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We represented a rural hospital in the Mountain West area from which a former nurse diverted over 1,000 hydrocodone and...
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We are representing a national network of radiology practices in a preemptive review of its controlled substances procedures. We are...
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We represent a multi-state behavioral health and addiction care company in analyzing the potential ramifications of a Southeastern state’s medical...
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We represent a Southeast hospice-company physician who was recently identified by the state Board of Licensing as a “high-risk” provider...
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We represent a Southeastern health system in responding to an investigation by the FDA, following notification by a manufacturer of...
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We represent a national pharmacy company in an enforcement proceeding alleging violations of the Controlled Substances Act by the Department...
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We assisted a national healthcare system in drafting initial notifications and DEA Form 106s after diversion events at hospitals across...
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We are working with former DEA Special Agents and Diversion Investigators, whom we have engaged as outside consultants, to facilitate...
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We represent a national long-term care pharmacy company through the negotiation of a consent order with the state Board of...
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Representation of National Healthcare System of Potential Diversion and Updated Compliance ProcessesWe represent a Texas hospital and its national healthcare system in investigating potential diversion by a former hospital nurse. We...
Experience
-
We represented a rural hospital in the Mountain West area from which a former nurse diverted over 1,000 hydrocodone and...
-
We are representing a national network of radiology practices in a preemptive review of its controlled substances procedures. We are...
-
We represent a multi-state behavioral health and addiction care company in analyzing the potential ramifications of a Southeastern state’s medical...
-
We represent a Southeast hospice-company physician who was recently identified by the state Board of Licensing as a “high-risk” provider...
-
We represent a Southeastern health system in responding to an investigation by the FDA, following notification by a manufacturer of...
-
We represent a national pharmacy company in an enforcement proceeding alleging violations of the Controlled Substances Act by the Department...
-
We assisted a national healthcare system in drafting initial notifications and DEA Form 106s after diversion events at hospitals across...
-
We are working with former DEA Special Agents and Diversion Investigators, whom we have engaged as outside consultants, to facilitate...
-
We represent a national long-term care pharmacy company through the negotiation of a consent order with the state Board of...
-
Representation of National Healthcare System of Potential Diversion and Updated Compliance ProcessesWe represent a Texas hospital and its national healthcare system in investigating potential diversion by a former hospital nurse. We...
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Professionals
| Name | Phone | |
|---|---|---|
|
Theresa A. Androff Senior Litigation Attorney |
(615) 742-7933 | Theresa.Androff@bassberry.com |
|
Nathan F. Brown Associate |
(615) 742-7715 | nathan.brown@bassberry.com |
|
Garrah Carter-Mason Associate |
(615) 742-7781 | garrah.cartermason@bassberry.com |
|
J. Taylor Chenery Member |
(615) 742-7924 | tchenery@bassberry.com |
|
Hannah Choate Member |
(615) 742-6221 | hannah.choate@bassberry.com |
|
Jeffrey I. Davis Member |
(202) 827-7082 | jeff.davis@bassberry.com |
|
John C. Eason Member |
(615) 742-7830 | jeason@bassberry.com |
|
Mary Beth Fortugno Member |
(615) 742-7739 | mfortugno@bassberry.com |
|
Lauren M. Gaffney Member |
(615) 742-7824 | lgaffney@bassberry.com |
|
Maleaka N. Guice Associate |
(615) 742-7899 | maleaka.guice@bassberry.com |
|
Michael R. Hess Member |
(901) 543-5713 | mhess@bassberry.com |
|
Brian Irving Member |
(615) 742-7769 | birving@bassberry.com |
|
Dante G. Lizza Associate |
(901) 543-5709 | dante.lizza@bassberry.com |
|
Heather M. Pearson Associate |
(202) 827-7093 | Heather.pearson@bassberry.com |
|
Lisa S. Rivera Member |
(615) 742-7707 | lrivera@bassberry.com |
|
Laurence B. Russell Counsel |
(202) 827-7085 | larry.russell@bassberry.com |
|
Shannon Wiley Member |
(901) 543-5987 | swiley@bassberry.com |
Publications
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March 6, 2025 | Firm Publication
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December 20, 2024 | Firm Publication
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September 6, 2024 | Firm Publication
Past Events
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December 4, 2025 | Nashville, TennesseeBass, Berry & Sims
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May 12, 2025 | WebinarBass, Berry & Sims
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December 5, 2024 | Nashville, TennesseeBass, Berry & Sims
Media Mentions & Firm News
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November 14, 2025 | Law360
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August 12, 2025 | Benchmark Litigation
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August 11, 2025 | Corporate Counsel
Publications
-
March 6, 2025 | Firm Publication
-
December 20, 2024 | Firm Publication
-
September 6, 2024 | Firm Publication
Past Events
-
December 4, 2025 | Nashville, TennesseeBass, Berry & Sims
-
May 12, 2025 | WebinarBass, Berry & Sims
-
December 5, 2024 | Nashville, TennesseeBass, Berry & Sims
Media Mentions & Firm News
-
November 14, 2025 | Law360
-
August 12, 2025 | Benchmark Litigation
-
August 11, 2025 | Corporate Counsel
Contact
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.
Notice
Visiting, or interacting with, this website does not constitute an attorney-client relationship. Although we are always interested in hearing from visitors to our website, we cannot accept representation on a new matter from either existing clients or new clients until we know that we do not have a conflict of interest that would prevent us from doing so. Therefore, please do not send us any information about any new matter that may involve a potential legal representation until we have confirmed that a conflict of interest does not exist and we have expressly agreed in writing to the representation. Until there is such an agreement, we will not be deemed to have given you any advice, any information you send may not be deemed privileged and confidential, and we may be able to represent adverse parties.