Reimbursement for Subject Injuries in Clinical Trials How to Avoid an ‘Adverse Event’ to Your Business

Held Feb. 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.

Is your sponsor- site contract up to standards?

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Are your clinical trial agreement programs CMS and HHS ready? Are you sure?

David A. Charapp and Erin M. Duffy of Duane Morris LLP share all the details you need for an effective clinical trial agreement.

With the CD and transcript of the Reimbursement for Subject Injuries in Clinical Trials webinar you will successfully:

  • Understand how Medicare reimburses for clinical trial Injuries.
  • Understand the Medicare Secondary Payor Requirements.
  • Learn when the Medicare Secondary Payor  and HIPAA rules apply to research sponsors and clinical sites.
  • Avoid the risks and penalties for failure to comply with the Medicare Secondary Payor requirements
  • Review clinical trial agreements and HIPAA authorizations in light of the Medicare Secondary Payor requirements

Sponsors and providers need to be prepared when something goes wrong, and your contract must cover all the right steps to ensure you are staying within regulations.

If you’re involved in clinical trial agreement negotiations you simply can’t miss the CD and transcript of the, Reimbursement for Subject Injuries in Clinical Trials: How to Avoid an ‘Adverse Event’ to Your Business webinar.

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Meet Your Instructor

David A. Charapp is partner at Duane Morris LLP and co-chair of the firm's Technology Transactions and Licensing Practice Group and represents life sciences and technology companies with their critical partnering, licensing and financing transactions, as well as operational agreements such as those for manufacturing and supply, distribution and clinical and preclinical research. Mr. Charapp has substantial experience as an in-house attorney, having been associate general counsel for Santarus, Inc., a specialty pharmaceutical company, and Kosan Biosciences Inc., a biotechnology company acquired by Bristol-Myers Squibb. Mr. Charapp earned his law degree from Boston College Law School (J.D., magna cum laude, 1997), where he was elected to the Order of the Coif.

Erin M. Duffy is an associate at Duane Morris LLP where she concentrates her practice on corporate healthcare regulatory matters. She advises clients on a wide range of issues, including fraud and abuse, self-referral, Medicare and Medicaid reimbursement, corporate practice of medicine and fee-splitting prohibitions, tax-exempt status, and certificate of need and licensure issues. She is also experienced in handling healthcare information technology matters, including mobile (mHealth) and electronic health records. Ms. Duffy is a graduate of Temple University Beasley School of Law.

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Individuals involved in:

  • Clinical trial agreement negotiations
  • Clinical operations
  • Medicare billing and compliance
  • HIPAA compliance
  • Clinical investigators
  • Regulatory affairs professionals
  • Consultants/service providers
  • Executive management
  • General/corporate counsel

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600