People

Gina Cavalier is healthcare fraud and abuse and compliance lawyer, who focuses her practice on the life sciences industry. A partner in our FDA and Healthcare practices, Gina advises a wide range of life sciences and healthcare clients, including pharmaceutical and medical device manufacturers, suppliers, providers, and group purchasing organizations. She specializes in advising these clients on complex issues arising under the Anti-Kickback Statute, as well as other federal and state anti-fraud authorities.

Gina regularly assists clients during fraud investigations and audits, and analyzes complex health care arrangements under the Anti-Kickback, Stark, Beneficiary Inducement and False Claims laws. She has handled a wide range of government inquiries, negotiated settlements and corporate integrity agreements ("CIAs"), drafted numerous corporate compliance programs and counseled clients regarding the structure of joint ventures. She also has significant experience providing advice to pharmaceutical and medical device manufacturers, particularly related to sales and marketing practices, and complex discounting arrangements, including bundling.

In addition, Gina is a Certified Information Privacy Professional ("CIPP"), a credential awarded by the International Association of Privacy Professionals that demonstrates expertise in privacy law. She has significant expertise in healthcare-related privacy laws, principally the Health Insurance Portability and Accountability Act ("HIPAA"), as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and related implementing regulations including the Privacy, Security and Breach Notification Rules, as well as state law.

Named one of the nation’s Life Science Stars by LMG Life Sciences, Gina has also been recommended by The Legal 500 for her work in life sciences and healthcare.

Gina is a member of the Board of Directors of Story District, a non-profit organization supporting the Washington, D.C. community, diversity and performing arts, through the art of live storytelling.

Full Bio

Credentials

J.D., Georgetown University, cum laude

B.A., Boston University, summa cum laude, Phi Beta Kappa

District of Columbia

New York

Law Clerk, Mary Ellen Bittner, Department of Justice, DEA

AHLA

IAPP

Selected as a Life Sciences Star


LMG Life Sciences, 2012–2018

Identified as a go-to attorney for government investigations for life sciences companies


LMG Life Sciences, 2014–2016

Litigation Star for Washington, D.C.


Benchmark Litigation, 2015

Recognized for her work in Healthcare and Life Sciences


Legal 500, 2013–2014

"Outstanding" healthcare lawyer who "wins industry recognition" for her work in health care information privacy and security


Legal 500, 2010–2011

Named one of the nation's Outstanding Young Healthcare Lawyers


Nightingale's Healthcare News, September 2009

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Recognition

Selected as a Life Sciences Star


LMG Life Sciences, 2012–2018

Identified as a go-to attorney for government investigations for life sciences companies


LMG Life Sciences, 2014–2016

Litigation Star for Washington, D.C.


Benchmark Litigation, 2015

Recognized for her work in Healthcare and Life Sciences


Legal 500, 2013–2014

"Outstanding" healthcare lawyer who "wins industry recognition" for her work in health care information privacy and security


Legal 500, 2010–2011

Named one of the nation's Outstanding Young Healthcare Lawyers


Nightingale's Healthcare News, September 2009

Matters

Handled numerous fraud investigations involving alleged violations of the Anti-Kickback Statute and False Claims Act and negotiated attendant settlement agreements and corporate integrity agreements for medical device manufacturers and healthcare providers.

Represented CVS, the nation’s largest retail pharmacy, in a joint investigation by the FTC and the HHS, Office for Civil Rights into health information privacy and security issues. Favorably resolved allegations of HIPAA violations by negotiating resolution agreement for $2.25 million and a corrective action plan.

Trained medical device manufacturers on a wide-range of healthcare regulatory topics, including fraud and abuse and enforcement, HIPAA privacy and security, and healthcare reimbursement and payment systems.

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Matters

Handled numerous fraud investigations involving alleged violations of the Anti-Kickback Statute and False Claims Act and negotiated attendant settlement agreements and corporate integrity agreements for medical device manufacturers and healthcare providers.

Represented CVS, the nation’s largest retail pharmacy, in a joint investigation by the FTC and the HHS, Office for Civil Rights into health information privacy and security issues. Favorably resolved allegations of HIPAA violations by negotiating resolution agreement for $2.25 million and a corrective action plan.

Trained medical device manufacturers on a wide-range of healthcare regulatory topics, including fraud and abuse and enforcement, HIPAA privacy and security, and healthcare reimbursement and payment systems.

Counseled AdvaMed in connection with drafting the update to its Code of Ethics on Interactions with Health Care Professionals.

Developed compliance programs, and related policies and procedures for medical device companies, including specific polices related to discounts, evaluation products, training and grants.

Prepared comprehensive policies and procedures for covered entities and business associate to ensure compliance with HIPAA/HITECH. Drafted numerous other HIPAA-compliant materials including Notices of Privacy Practices, authorizations and business associate agreements.

Matters

Handled numerous fraud investigations involving alleged violations of the Anti-Kickback Statute and False Claims Act and negotiated attendant settlement agreements and corporate integrity agreements for medical device manufacturers and healthcare providers.

Represented CVS, the nation’s largest retail pharmacy, in a joint investigation by the FTC and the HHS, Office for Civil Rights into health information privacy and security issues. Favorably resolved allegations of HIPAA violations by negotiating resolution agreement for $2.25 million and a corrective action plan.

Trained medical device manufacturers on a wide-range of healthcare regulatory topics, including fraud and abuse and enforcement, HIPAA privacy and security, and healthcare reimbursement and payment systems.

See more
Icon close

Close

Matters

Handled numerous fraud investigations involving alleged violations of the Anti-Kickback Statute and False Claims Act and negotiated attendant settlement agreements and corporate integrity agreements for medical device manufacturers and healthcare providers.

Represented CVS, the nation’s largest retail pharmacy, in a joint investigation by the FTC and the HHS, Office for Civil Rights into health information privacy and security issues. Favorably resolved allegations of HIPAA violations by negotiating resolution agreement for $2.25 million and a corrective action plan.

Trained medical device manufacturers on a wide-range of healthcare regulatory topics, including fraud and abuse and enforcement, HIPAA privacy and security, and healthcare reimbursement and payment systems.

Counseled AdvaMed in connection with drafting the update to its Code of Ethics on Interactions with Health Care Professionals.

Developed compliance programs, and related policies and procedures for medical device companies, including specific polices related to discounts, evaluation products, training and grants.

Prepared comprehensive policies and procedures for covered entities and business associate to ensure compliance with HIPAA/HITECH. Drafted numerous other HIPAA-compliant materials including Notices of Privacy Practices, authorizations and business associate agreements.

Credentials

J.D., Georgetown University, cum laude

B.A., Boston University, summa cum laude, Phi Beta Kappa

District of Columbia

New York

Law Clerk, Mary Ellen Bittner, Department of Justice, DEA

AHLA

IAPP

Selected as a Life Sciences Star


LMG Life Sciences, 2012–2018

Identified as a go-to attorney for government investigations for life sciences companies


LMG Life Sciences, 2014–2016

Litigation Star for Washington, D.C.


Benchmark Litigation, 2015

Recognized for her work in Healthcare and Life Sciences


Legal 500, 2013–2014

"Outstanding" healthcare lawyer who "wins industry recognition" for her work in health care information privacy and security


Legal 500, 2010–2011

Named one of the nation's Outstanding Young Healthcare Lawyers


Nightingale's Healthcare News, September 2009

Icon close

Close

Recognition

Selected as a Life Sciences Star


LMG Life Sciences, 2012–2018

Identified as a go-to attorney for government investigations for life sciences companies


LMG Life Sciences, 2014–2016

Litigation Star for Washington, D.C.


Benchmark Litigation, 2015

Recognized for her work in Healthcare and Life Sciences


Legal 500, 2013–2014

"Outstanding" healthcare lawyer who "wins industry recognition" for her work in health care information privacy and security


Legal 500, 2010–2011

Named one of the nation's Outstanding Young Healthcare Lawyers


Nightingale's Healthcare News, September 2009