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Shannon Cox represents clients in connection with government investigations, regulatory enforcement actions, and related civil litigation. Her experience includes a wide range of matters brought by federal and state regulatory agencies and state Attorneys General, as well as consumer class actions, multi-district proceedings, and False Claims Act litigation. Shannon also focuses on providing compliance program advice to help clients appropriately manage regulatory risks and minimize the potential for regulatory enforcement activity.

Shannon is a Certified Compliance & Ethics Professional and conducts compliance program reviews, advises clients on designing effective compliance programs, and assists clients with the development and improvement of policies, procedures, and training materials.

Shannon has particular subject matter expertise with regard to controlled substance and pharmacy regulatory issues.  She represents hospital, retail pharmacy, and other healthcare clients in investigations and enforcement actions brought by the Drug Enforcement Administration, state licensing boards, and state controlled substance authorities. Shannon also provides regulatory advice, conducts internal compliance reviews, and assists healthcare clients in developing effective compliance programs to mitigate the regulatory risks associated with controlled substance operations. She also has experience with controlled substance and pharmacy issues in the context of Medicare and Medicaid reimbursement, including False Claims Act litigation.

Full Bio

Credentials

J.D., Emory University, with distinction

B.A., Southern Methodist University, cum laude

Georgia

Texas

U.S. Court of Appeals for the Eleventh Circuit

U.S. Court of Appeals for the Fifth Circuit

U.S. District Court for the Northern District of Georgia

Matters

Represented hospital client in connection with a joint investigation by the Drug Enforcement Administration and the U.S. Attorney's Office regarding controlled substance diversion controls.

Represented nationwide credit reporting agency in connection with investigations and enforcement actions by the Attorneys General of all 50 states, Puerto Rico, and the District of Columbia regarding 2017 cybersecurity incident.

Conducted multiple internal investigations relating to controlled substance and listed chemical diversion issues, including thefts, losses, and suspicious orders.

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Matters

Represented hospital client in connection with a joint investigation by the Drug Enforcement Administration and the U.S. Attorney's Office regarding controlled substance diversion controls.

Represented nationwide credit reporting agency in connection with investigations and enforcement actions by the Attorneys General of all 50 states, Puerto Rico, and the District of Columbia regarding 2017 cybersecurity incident.

Conducted multiple internal investigations relating to controlled substance and listed chemical diversion issues, including thefts, losses, and suspicious orders.

Represented a national retail pharmacy chain in False Claims Act litigation relating to usual and customary pricing and government healthcare program reimbursement issues.

Conducted multiple privileged compliance reviews to assess the effectiveness of company policies and procedures and internal controls at retail, specialty, and mail order pharmacies.

Advised retail pharmacy client regarding the development and implementation of compliance program enhancements required by federal non-prosecution agreement.

Represented a Fortune 100 company in connection with federal and state government investigations and regulatory enforcement actions regarding retail pharmacy controlled substance dispensing and diversion issues.

Advised pharmacy and hospital clients, including Fortune 100 companies, regarding federal and state controlled substance and pharmacy laws.

Developed and presented numerous training programs for in-house legal and compliance personnel, field management, and store level employees addressing issues such as controlled substance dispensing, diversion, and recordkeeping.

Advised clients regarding the development and revision of policies and procedures relating to issues such as controlled substance dispensing, drug disposal, diversion reporting, and the Drug Supply Chain Security Act.

Advised a hospital group with regard to the implementation of a remote medication order entry program, including the development of policies and procedures and contracts with remote service providers.

Represented a pharmaceutical virtual manufacturer and a sterile compounding outsourcing facility in connection with obtaining non-resident state pharmacy licenses.

Assisted a closed-door pharmacy providing compliance packaging services with issues relating to Medicaid provider applications.

Provided advice to clients with respect to due diligence analysis of pharmacy compliance risks associated with potential mergers and acquisitions.

Developed multi-state pharmacy regulatory database for use by client’s in-house legal and operations personnel covering a range of topics including sterile compounding, remote prescription order entry, individual and facility licensure, and prescribing authority of mid-level practitioners.

Represented a major home improvement retailer in various consumer class action proceedings, including cases alleging violations of the Telephone Consumer Protection Act.

Conducted an internal investigation regarding allegations of employment discrimination and sexual harassment.

Represented a global package delivery company in a nationwide class action alleging fraud and overcharging in connection with billing practices.

Provided pro bono advice to non-profit organization operating a drug donation program regarding reverse distribution and pharmacy licensing issues; advised a non-profit HIV/AIDS service provider regarding 340B drug discount program and pharmacy operations outsourcing issues; represented a non-profit organization providing support for disabled individuals in connection with third party law enforcement and civil litigation subpoenas.

Insights

Article · Source: Chain Drug Review

April 27, 2020
COVID-19 pandemic sparks regulatory changes for Rx

Article · Source: Chain Drug Review

August 15, 2019
Cannabis-Based Product Rules Continue to Vary

View all

Matters

Represented hospital client in connection with a joint investigation by the Drug Enforcement Administration and the U.S. Attorney's Office regarding controlled substance diversion controls.

Represented nationwide credit reporting agency in connection with investigations and enforcement actions by the Attorneys General of all 50 states, Puerto Rico, and the District of Columbia regarding 2017 cybersecurity incident.

Conducted multiple internal investigations relating to controlled substance and listed chemical diversion issues, including thefts, losses, and suspicious orders.

See more
Icon close

Close

Matters

Represented hospital client in connection with a joint investigation by the Drug Enforcement Administration and the U.S. Attorney's Office regarding controlled substance diversion controls.

Represented nationwide credit reporting agency in connection with investigations and enforcement actions by the Attorneys General of all 50 states, Puerto Rico, and the District of Columbia regarding 2017 cybersecurity incident.

Conducted multiple internal investigations relating to controlled substance and listed chemical diversion issues, including thefts, losses, and suspicious orders.

Represented a national retail pharmacy chain in False Claims Act litigation relating to usual and customary pricing and government healthcare program reimbursement issues.

Conducted multiple privileged compliance reviews to assess the effectiveness of company policies and procedures and internal controls at retail, specialty, and mail order pharmacies.

Advised retail pharmacy client regarding the development and implementation of compliance program enhancements required by federal non-prosecution agreement.

Represented a Fortune 100 company in connection with federal and state government investigations and regulatory enforcement actions regarding retail pharmacy controlled substance dispensing and diversion issues.

Advised pharmacy and hospital clients, including Fortune 100 companies, regarding federal and state controlled substance and pharmacy laws.

Developed and presented numerous training programs for in-house legal and compliance personnel, field management, and store level employees addressing issues such as controlled substance dispensing, diversion, and recordkeeping.

Advised clients regarding the development and revision of policies and procedures relating to issues such as controlled substance dispensing, drug disposal, diversion reporting, and the Drug Supply Chain Security Act.

Advised a hospital group with regard to the implementation of a remote medication order entry program, including the development of policies and procedures and contracts with remote service providers.

Represented a pharmaceutical virtual manufacturer and a sterile compounding outsourcing facility in connection with obtaining non-resident state pharmacy licenses.

Assisted a closed-door pharmacy providing compliance packaging services with issues relating to Medicaid provider applications.

Provided advice to clients with respect to due diligence analysis of pharmacy compliance risks associated with potential mergers and acquisitions.

Developed multi-state pharmacy regulatory database for use by client’s in-house legal and operations personnel covering a range of topics including sterile compounding, remote prescription order entry, individual and facility licensure, and prescribing authority of mid-level practitioners.

Represented a major home improvement retailer in various consumer class action proceedings, including cases alleging violations of the Telephone Consumer Protection Act.

Conducted an internal investigation regarding allegations of employment discrimination and sexual harassment.

Represented a global package delivery company in a nationwide class action alleging fraud and overcharging in connection with billing practices.

Provided pro bono advice to non-profit organization operating a drug donation program regarding reverse distribution and pharmacy licensing issues; advised a non-profit HIV/AIDS service provider regarding 340B drug discount program and pharmacy operations outsourcing issues; represented a non-profit organization providing support for disabled individuals in connection with third party law enforcement and civil litigation subpoenas.

Insights

Article · Source: Chain Drug Review

April 27, 2020
COVID-19 pandemic sparks regulatory changes for Rx

Article · Source: Chain Drug Review

August 15, 2019
Cannabis-Based Product Rules Continue to Vary

View all

Credentials

J.D., Emory University, with distinction

B.A., Southern Methodist University, cum laude

Georgia

Texas

U.S. Court of Appeals for the Eleventh Circuit

U.S. Court of Appeals for the Fifth Circuit

U.S. District Court for the Northern District of Georgia