Structuring a Compensation Framework for Clinical Research
Mitigating Fraud and Abuse Risks for Healthcare Providers, Navigating FMV in Clinical Research Budgeting, Lessons From Recent Enforcement
Recording of a 90-minute CLE webinar with Q&A
This CLE webinar will review the status of, and recent developments in, the laws implicated by clinical research relationships, and provide guidance to healthcare counsel to create a framework for smart research funding and compensation planning.
- Physicians and clinical research activity
- Areas of risk
- Stark Law
- Best practices for creating a framework for compensation
- Factors to consider
- Sponsor needs and goals
- Investigator needs and goals
- Regulatory enforcement environment
- Role of fair market value in clinical research budgeting
- Factors to consider
Discussion topics will include specific legal risks and strategies for mitigating those risks, including:
- How the flow of clinical research dollars from sponsors to providers may or may not implicate Federal and state laws, such as anti-kickback laws, self-referral laws, tax exemption requirements for not-for-profit entities, and the Foreign Corrupt Practices Act for parties engaged in international research activities.
- Lessons learned from recent enforcement actions, including the importance of (and factors that determine) reasonable, fair market value research compensation.
- Real world examples, tips and strategies for creating a long term and sustainable regulatory compliance and risk mitigation framework for clients involved in clinical research.
Associate General Counsel
Ms. Binkley is operations counsel for LifePoint Health affiliated hospitals, providing support for 15 hospital campuses... | Read More
Ms. Binkley is operations counsel for LifePoint Health affiliated hospitals, providing support for 15 hospital campuses in 8 states. She has worked as ops counsel for multiple systems with varying levels of clinical research programs. She has served in both the operations capacity as a hospital COO as well as in the legal capacity as counsel to various types of clients in the healthcare industry, including non-urban and urban for-profit hospitals as well as clinical research centers and physician groups affiliated with those systems.Close
KT Farley, JD, MS
Ms. Farley advises on clinical research matters, including the development of research budgets, negotiation of clinical... | Read More
Ms. Farley advises on clinical research matters, including the development of research budgets, negotiation of clinical trial agreements, protection of human subjects, and compliance with the regulatory framework governing the intricacies of such work. Prior to joining Sutter Health, KT worked for an academic medical center, where she managed agreements for research and innovation initiatives and oversaw the contracting, compliance and regulatory functions of a centralized clinical trials office with a large, diverse research portfolio. KT has also advised healthcare groups across the country on information security and privacy matters.Close
Andrea M. Ferrari, JD, MPH
Ms. Ferrari is a Partner based in the Boca Raton... | Read More
Ms. Ferrari is a Partner based in the Boca Raton office of HealthCare Appraisers. Ms. Ferrari works with clients in all 50 states. Her focus areas include:
- Assisting clients in the transition to value-based payments, including structuring, evaluating and identifying issues in incentive payments made in the context of coordinated care and alignment strategies, such as formation of clinically integrated networks, accountable care organizations, gainsharing arrangements and “Hospital Quality and Efficiency Programs”;
- Fair market value in clinical research and clinical trial agreements, including assisting clients with budgeting for clinical research and planning provider compensation in the context of clinical research and clinical trial agreements;
- Valuation of provider recruitment and retention strategies, including income guarantees and recruitment bonuses for providers in shortage areas;
- Compensation valuations for public, tax-supported and safety-net provider organizations, including public hospitals and health systems;
- Compensation for academic and uniquely experienced Thought Leader and “Rockstar” physicians; and
- Fair market value analysis for due diligence and litigation support.
Arnold & Porter Kaye Scholer
Ms. Ramer represents major pharmaceutical and medical device companies in criminal and civil government investigations... | Read More
Ms. Ramer represents major pharmaceutical and medical device companies in criminal and civil government investigations involving allegations of healthcare fraud, including off-label promotion, anti-kickback statute violations, False Claims Act violations and other issues related to sales, marketing and pricing practices. She also conducts internal investigations and litigates cases brought under the federal False Claims Act and state laws, including state false claims acts and deceptive trade practices statutes. In addition, Ms. Ramer has developed fraud and abuse training for clients and advises companies on their compliance programs.Close