Medicare can help companies defray the cost of drug and device clinical trials by paying for some services delivered to program beneficiaries enrolled in “qualified” trials. In considering whether to seek Medicare coverage, trial sponsors and clinical sites need to be aware of the administrative obstacles introduced by the need to comply with fraud and abuse regulations and the Secondary Payer Statute.

This conference provides a detailed review of Medicare’s clinical trial coverage policies, the different rules that apply to device (IDE) and pharmaceutical (IND) trials, and the compliance issues that complicate the decision to seek Medicare funding.

This audio conference covers:

• Which trials qualify for coverage and which do not
• How and why coverage is different for IND and IDE trials
• Which services Medicare will pay for in a qualified trial
• FDA’s role in determining coverage for IDE trials
• How to bill for covered clinical trial services
• Why some IRBs and some patients don’t like Medicare trial coverage
• How to avoid fraud, abuse and secondary payer compliance problems, and how it can complicate trial management

About the speaker:

Edward Berger, PhD, is a senior healthcare executive with more than 25 years of experience in medical device reimbursement analysis, planning and advocacy. He founded Larchmont Strategic Advisors in 2005 to help life sciences companies deal effectively with the strategic challenges and opportunities posed by the rapidly evolving healthcare regulatory and policy environment.

Building upon the knowledge and experience gained as a member of the management teams of such companies as Fresenius Medical Care, Thermo Cardiosystems and ABIOMED, Dr. Berger has provided reimbursement analysis and strategy development consultation to a variety of clients developing new technologies in fields including mechanical circulatory support, neural monitoring and neuromodulation, gastrointestinal surgery, severe pulmonary dysfunction, nuclear medicine, diagnostic imaging, clinical laboratory testing and personalized medicine.

Who should attend?

• Regulatory Affairs & Reimbursement Professionals
• Clinical Trial Managers
• Compliance Officers
• VPs of Clinical Affairs
• Corporate Counsel
• VPs & Directors of Finance