Clinical Trials: Emerging Legal Threats
Strategies to Survive Heightened Government Scrutiny
Recording of a 90-minute CLE webinar with Q&A
This seminar will examine the legal implications of conducting clinical research trials, litigation risks of clinical trials, and best practices for hospitals and physicians to avoid missteps that create liability exposure.
Outline
- Fraud and abuse risks of conducting clinical trials
- False Claims Act implications
- Anti-kickback implications
- Litigation risks associated with clinical trials
- Informed consent
- Contracts/indemnification issues
- Medical risks
- Conflicts of interest
- Constitutional issues
- Best practices for compliance
- Medicare billing
- Privacy and security issues
- Register clinical trials with www.clinicaltrials.gov per FDA Amendment Act of 2007
- Develop or update written policies and procedures
- Comply with relevant government regulations
Benefits
The panel will review these and other key questions:
- What clinical trial activities give rise to potential False Claims Act liability?
- What are the Anti-kickback risks of conducting clinical trials?
- What should providers and hospitals do now to limit their liability for the risks of conducting clinical trials?
- What are the unresolved issues concerning Medicare billing for clinical trials?
Faculty
Katherine Benesch
Partner
Duane Morris
She practices in the areas of healthcare law, litigation and alternative dispute resolution, with particular emphasis... | Read More
She practices in the areas of healthcare law, litigation and alternative dispute resolution, with particular emphasis on fraud and abuse, including Stark Law, anti-kickback and False Claims Act issues. As an arbitrator, she handles many types of cases, including disputes over clinical research trials.
CloseKirk L. Dobbins
Counsel
King & Spalding
He is a member of the firm's FDA/Healthcare Practice Group. He brings more than 13 years of experience to his practice,... | Read More
He is a member of the firm's FDA/Healthcare Practice Group. He brings more than 13 years of experience to his practice, including more than seven years advising and representing federal agencies. He frequently speaks at conferences and has written articles on Medicare coverage and policy for national publications.
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Robert E. Wanerman
Member
Epstein Becker & Green
Mr. Wanerman’s practice concentrates on regulatory, reimbursement, and compliance matters affecting healthcare... | Read More
Mr. Wanerman’s practice concentrates on regulatory, reimbursement, and compliance matters affecting healthcare manufacturers, service providers, and investors in healthcare organizations. He has extensive experience counseling clients in matters arising under the Medicare and Medicaid programs, administrative law and procedure, the False Claims Act, clinical research rules, grant administration rules, the Anti-Kickback and Stark laws, HIPAA, and EMTALA. Mr. Wanerman was formerly an assistant counsel at the U.S. Department of Health and Human Services.
CloseAccess Anytime, Anywhere
Strafford will process CLE credit for one person on each recording. All formats include course handouts.
CLE On-Demand Audio