Stewart Kameen advises healthcare clients on all aspects of federal and state healthcare laws and regulations, with a particular emphasis on fraud and abuse regulatory counseling, corporate compliance, internal investigations and government enforcement actions, qui tam litigation, and transactional matters. Stewart is able to counsel providers drawing on his unique perspective informed by his experience working at the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG). He brings extensive expertise in life sciences, device and distribution, and pharmaceutical manufacturing, making him a vital ally for clients in the healthcare and biotech sectors.
While working at HHS-OIG as Senior Counsel in the Office of Counsel to the Inspector General—Industry Guidance Branch—Stewart was a lead author of several of the proposed and final safe harbors HHS-OIG issued as part of the Regulatory Sprint to Coordinated Care (“Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements,” 85 FR 77684, Dec. 2, 2020). As one of the core drafters of these new regulations, he often collaborated with officials from HHS-OIG, the Centers for Medicare & Medicaid Services, the Department of Justice (DOJ), and the Office of the National Coordinator for Health Information Technology.
In his tenure with HHS-OIG, Stewart also handled numerous requests for advisory opinions seeking guidance related to the federal anti-kickback statute and the civil monetary penalty provisions for beneficiary inducements. In addition, he provided regular advice regarding federal fraud and abuse laws related to the clearance of numerous HHS proposed and final regulations, and technical assistance to DOJ attorneys involving OIG authorities, most significantly involving enforcement and other major litigation related to patient assistance program donations. Stewart also played a significant role in HHS-OIG’s efforts to provide temporary enforcement guidance regarding arrangements directly connected to the COVID-19 public health emergency.
Stewart applies his experience while working at HHS-OIG to help clients stay compliant with federal and state regulatory requirements. Prior to his work with the government, Stewart was an attorney in the healthcare practice of a national law firm. Stewart’s deep understanding of the life sciences industry allows him to offer strategic counsel on matters ranging from market entry to patient access. Additionally, Stewart’s knowledge of pharmaceutical and device manufacturing and distribution equips him to address challenges related to compliance and risk management.
Stewart Kameen advises healthcare clients on all aspects of federal and state healthcare laws and regulations, with a particular emphasis on fraud and abuse regulatory counseling, corporate compliance, internal investigations and government enforcement actions, qui tam litigation, and transactional matters. Stewart is able to counsel providers drawing on his unique perspective informed by his experience working at the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG). He brings extensive expertise in life sciences, device and distribution, and pharmaceutical manufacturing, making him a vital ally for clients in the healthcare and biotech sectors.
While working at HHS-OIG as Senior Counsel in the Office of Counsel to the Inspector General—Industry Guidance Branch—Stewart was a lead author of several of the proposed and final safe harbors HHS-OIG issued as part of the Regulatory Sprint to Coordinated Care (“Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements,” 85 FR 77684, Dec. 2, 2020). As one of the core drafters of these new regulations, he often collaborated with officials from HHS-OIG, the Centers for Medicare & Medicaid Services, the Department of Justice (DOJ), and the Office of the National Coordinator for Health Information Technology.
In his tenure with HHS-OIG, Stewart also handled numerous requests for advisory opinions seeking guidance related to the federal anti-kickback statute and the civil monetary penalty provisions for beneficiary inducements. In addition, he provided regular advice regarding federal fraud and abuse laws related to the clearance of numerous HHS proposed and final regulations, and technical assistance to DOJ attorneys involving OIG authorities, most significantly involving enforcement and other major litigation related to patient assistance program donations. Stewart also played a significant role in HHS-OIG’s efforts to provide temporary enforcement guidance regarding arrangements directly connected to the COVID-19 public health emergency.
Stewart applies his experience while working at HHS-OIG to help clients stay compliant with federal and state regulatory requirements. Prior to his work with the government, Stewart was an attorney in the healthcare practice of a national law firm. Stewart’s deep understanding of the life sciences industry allows him to offer strategic counsel on matters ranging from market entry to patient access. Additionally, Stewart’s knowledge of pharmaceutical and device manufacturing and distribution equips him to address challenges related to compliance and risk management.
