Health care and life sciences companies, along with investors, look to Brian to navigate complex regulatory, strategic, and transactional matters and to find pragmatic solutions. This includes advising on compliance with myriad federal and state laws, providing transactional guidance and managing regulatory due diligence, and assisting with responses to government audits and investigations. Brian’s clients include medical device and pharmaceutical manufacturers, hospitals and health systems, digital health companies, managed care organizations, long-term and post-acute care providers, specialty pharmacies, pharmacy benefit managers, and private equity investors that support these health care and life sciences companies.
In addition to counseling companies on regulatory compliance, business strategies, and transactional matters, Brian has successfully defended several for-profit and not-for-profit health care and life sciences companies in matters alleging violations of the False Claims Act (FCA) and the Civil Monetary Penalties Law, as well as with audits conducted by the Department of Health and Human Services, Office of Inspector General (HHS OIG) and the Centers for Medicare & Medicaid Services (CMS). Brian’s deep experience includes matters involving federal and state Anti-Kickback Statute and Stark Law concerns, allegations of inflated average wholesale prices for drugs and drug ingredients, and Medicare and Medicaid reimbursement and coverage criteria. Brian has also negotiated corporate integrity agreements with the HHS OIG and advised companies operating under these agreements.
Early in his career, Brian served as senior counsel at the HHS OIG, where he was team leader for the Boston, Miami, Dallas and San Francisco regions. He was also accepted into the highly competitive Department of Justice U.S. Attorney General’s Honors Program and was appointed as a special assistant U.S. attorney by a former U.S. attorney and current federal judge. In these roles, Brian represented the government in matters brought under the FCA, the Anti-Kickback Statute and the Stark Law, Medicare and Medicaid reimbursement rules, and off-label marketing restrictions.
Given his experience, Brian is a frequent presenter for several national industry associations. From 1999 to 2001, Brian served as a volunteer in the U.S. Peace Corps, where he was a science teacher (in the French language) for a school located in a remote village in Burkina Faso, West Africa.
