March 28, 2006
Rush University Settlement with HHS Clarifies Clinical Trial Billing Under Medicare
Audio Seminar Featuring Key Players in New World of Research Management and Billing
The rules governing billing Medicare for treatment provided through clinical trials have become more comprehensible with the recent landmark settlement of Rush University Medical Center that the HHS Office of Inspector General (OIG) has called a model for handling billing compliance issues.
Medical centers faced substantial uncertainty since 2000 when the federal government started encouraging Medicare beneficiaries to enroll in clinical trials by agreeing to pay for some of the expenses involved in experimental treatments.
The structure of the Medicare Program’s National Coverage Decision on Clinical Trials requires medical centers to determine which services are billable to Medicare and which are not, based on a variety of factors – including the sponsorship contract. This process may involve analyzing hundreds of services and items over the course of the patient’s treatment. Aspects of this Medicare rule have been unclear since its publication and raised many questions particularly over how to adjust operations to comply with the rule and how to manage compliance risks.
Now the settlement with Rush University Medical Center has answered a lot of questions. To explain the practical implications for the clinical trials research industry, Drug & Biologic Guidance Watch is sponsoring a 90 minute audio seminar:
New Approaches for Clinical Trial Billing under Medicare:
Lessons Learned from the Rush University Medical Center Settlement.
Participants are briefed on:
- Significant billing and accounting issues implicated by the National Coverage Decision on Clinical Trials that were central to the settlement;
- Key considerations in establishing compensation arrangements with the clinical trial sponsors;
- Creating effective financial analyses to determine research-related procedures that qualify for Medicare coverage;
- Establishing appropriate billing systems;
- Implications for the patient’s informed consent;
- What to do when problems occur;
- and much more.
Who Should Listen
Research Grant Managers
Institutional Review Board Members
Clinical Investigators and Study Coordinators
Contract Research Organizations
Pharmaceutical Research And Marketing Professionals
Medicare Billing Professionals
Patient Rights Representatives
Ryan Meade, Esq., is a partner in Meade & Roach, LLP and represented Rush as the attorney who negotiated its settlement with the Department of Justice and HHS Office of Inspector General. His practice focuses on Medicare/Medicaid billing compliance and clinical trial research compliance.
Lisa Murtha, Esq.,is a Managing Director for Huron Consulting Group based in New York and Philadelphia. Her practice focuses on clinical research, revenue cycle work, billing and coding issues, internal investigations, corporate governance/ethics, and HIPAA work. She previously served as a Principal in the Philadelphia office of Parente Randolph, LLC where she led the national healthcare compliance practice. She also served as the Vice President of Audit, Compliance for The Children's Hospital of Philadelphia.
Continuing Education Credits
- All seminar participants will receive a certificate of participation
The CD recording with all course materials are excellent educational and briefing resources: $260
Download the form at http://www.melamedia.com/032806RegForm.pdf and fax it to 703.619.4912