Former HHS, Office of Inspector General Senior Counsel Joins Berkeley Research Group
Berkeley Research Group announced that Kristen Schwendinger has joined the Health Analytics practice in the firm’s Washington, DC, office and will focus on Corporate Compliance and Risk Management.
She joins BRG from the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and has significant industry experience across provider and supplier entities. She will focus her consulting practice on pharmaceutical, biotech and medical device manufacturers, a wide array of healthcare providers, companies in other regulated industries and individuals on a variety of compliance-related issues, including federal healthcare laws and regulations; policies and procedures; compliance assessments related to Department of Justice (DOJ), Securities & Exchange Commission and other regulatory investigations; IRO monitoring and testing; CIA readiness assessments and reporting; and creative restructuring and reform.
Before joining BRG, Schwendinger served as a senior counsel at HHS OIG, where she focused on healthcare enforcement, compliance and investigations. She has experience in the government’s fraud investigation process, the False Claims Act, Anti-Kickback Statute, Civil Monetary Penalties Law and exclusions from federal healthcare programs. Schwendinger is a respected compliance professional, having managed numerous corporate integrity agreements while advancing the OIG’s approach to corporate monitoring.
“In a climate of increased scrutiny and accountability for compliance programs, it is an exciting time to join BRG’s Corporate Compliance and Risk Management team. I am honored to contribute to BRG’s impressive team, bringing knowledge from monitoring corporations as part of my expertise from HHS OIG,” said Schwendinger.
In a release, the company says:
Schwendinger brings deep experience to BRG for a wide range of providers to include grantees, contractors, life science companies, physician practices, hospitals, health centers, durable medical equipment, pharmacies, manufacturers and long-term care providers and suppliers. Among her accomplishments are collaborations on various matters with the National Institutes of Health, Food and Drug Administration and Centers for Disease Control and Prevention, as well as with HHS representatives at the Centers for Medicare & Medicaid Services. She also worked on OIG’s updated healthcare provider self-disclosure protocol, in addition to processes for disclosures by contractors or grantees.
Across hundreds of cases for which she obtained settlements or judgments, Schwendinger advocated for OIG’s enforcement positions related to hospice, home health, durable medical equipment, life science companies and individual providers. She served as OIG’s Grant and Contract Fraud coordinator, earning awards for excellence and innovation. She also served as a member of the grant fraud subcommittee for the DOJ’s Financial Fraud Task Force for HHS OIG. Working from the start of investigations through to resolutions, she took depositions and also handled appeals before the Departmental Appeals Board and federal courts. She championed an initiative for OIG to obtain new grant and contract Civil Monetary Penalty Law authority, which was enacted as a part of the 21st Century Cures Act.
“We are excited to have someone of Kristen’s caliber join BRG’s Corporate Compliance team. Her OIG and healthcare experience will strengthen our range of services to life sciences and other organizations, as well as their counsel.” said Ed Buthusiem, Managing Director of BRG’s Corporate Compliance and Risk Management team.
Prior to her time at the OIG, Schwendinger worked at IU Health (formerly Clarian Health) and Massachusetts General Hospital on community benefits tax reporting and research fundraising.