Duane Morris Attorneys David Charapp and Erin Duffy to Explore "Reimbursement for Subject Injuries in Clinical Trials How to Avoid an 'Adverse Event' to Your Business"
February 20, 2013 | Webinar
Duane Morris attorneys David Charapp and Erin Duffy will present a webinar on "Reimbursement for Subject Injuries in Clinical Trials How to Avoid an 'Adverse Event' to Your Business" for FDAnews on Wednesday, February 20, 2013.
Many sponsors and providers are either not aware of, or do not fully appreciate, the potential consequences of reimbursement for patient injury clauses in clinical trial agreements. In addition to potentially paying more than expected, unsuspecting sponsors may face an obligation to file reports with the Centers for Medicare & Medicaid Services, incur significant fines for failure to do so and run afoul of HIPAA obligations. Providers must be concerned when complying with Medicare regulations, balancing ethical considerations with institutional policies. In this webinar, Mr. Charapp and Ms. Duffy will share the details companies need to know for drafting an effective clinical trial agreement. Discussion will cover how Medicare reimburses for clinical trial injuries; the Medicare Secondary Payor Requirements; when the Medicare Secondary Payor and HIPAA rules apply to research sponsors and clinical sites; and how to avoid risks and penalties for failing to comply with requirements.
To learn more, or to register, visit the FDAnews website.