Brian A. Bohnenkamp

• Representing several pharmaceutical and medical device companies in Open Payments audits conducted by CMS.
• Defending a medical device manufacturer responding to a civil investigative demand from DOJ regarding meals and consulting relationships with HCPs.
• Defending a medical device manufacturer responding to a DOJ inquiry into billing and coding practices.
• Representing a medical products company responding to a criminal grand jury subpoena.
• Conducting comprehensive fraud and abuse analyses on pharma and device manufacturers' direct-to-patient sales programs.
• Conducting compliance program reviews for two pharma manufacturers to assess the effectiveness of their compliance programs and provide tactical ideas for improvement.
• Conducting a compliance assessment for a group purchasing organization.
• Supporting Market Access functions for pharmaceutical manufacturers, including providing assistance with PBM, GPO, and SP contracting matters.
• Assisting multiple pharmaceutical manufacturers in reorganizing corporate structure, including relationships between Commercial and Medical teams.
• Submitting multiple OIG advisory opinion requests on behalf of pharma and device companies.
• Providing counsel to the K&S Ad Hoc Sunshine and State Law Compliance Group, a coalition of pharmaceutical, biotechnology and medical device manufacturers that focuses on a range of regulatory and compliance requirements.

Brian Bohnenkamp focuses on fraud and abuse, regulatory, and compliance matters relating specifically to medical device, drug, and biotechnology companies. Brian has extensive experience with the Anti-Kickback Statute, False Claims Act, industry codes of conduct (PhRMA, AdvaMed, MDMA), federal and state transparency laws and regulations (Open Payments), state and local gift bans, and compliance program laws.  Brian often serves as a thought partner and sounding board to senior compliance and legal professionals at pharmaceutical and medical device companies. He spends much of his time working with in-house colleagues on various compliance questions, proposals and arrangements proposed by their businesses.  Brian also regularly defends life sciences companies being investigated by DOJ, HHS-OIG, CMS, and whistleblowers.  His perspectives are informed by day-to-day counseling and what he sees as focal points and trending risks in investigations and enforcement actions.  Brian is regarded as a national expert on life sciences issues in fraud and abuse, compliance, and enforcement. He has been recognized by Legal 500, Chambers, Best Lawyers, and Super Lawyers.