When: March 28, 2006
Contact: Dennis Melamed
703.704.5665
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 will be 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.
THE FACULTY:
The seminar features an
outstanding faculty, including some of the key players in the settlement
negotiations between Rush and the federal government.
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
principally focuses on Medicare/Medicaid
billing compliance and clinical trial research compliance. Ryan is assistant
professor at Rush University where he teaches health law courses. Ryan is also
an adjunct professor of law at Loyola University Chicago’s School of Law where
he teaches one of the few Medicare law courses in the country.
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. Prior to joining Parente
Randolph she served as the Vice President of Audit, Compliance and Chief
Privacy Officer for The Children’s Hospital of Philadelphia (CHOP), the Stokes
Research Institute, and The Children’s Hospital of Philadelphia Practice
Association
Who Should
Attend:
·
Research Managers
and Administrators
·
Research
Grant Managers
·
Institutional
Review Board Members
·
Clinical
Investigators and Study Coordinators
·
Contract
Research Organizations
·
Pharmaceutical
Research And Marketing Professionals
·
Medical
Device Manufacturers
·
Biologics Manufacturers
·
Medicare
Billing Professionals
·
Patient
Rights Representatives
·
Healthcare
Attorneys
·
Healthcare
Consultants
CD and Course Materials are
available for $260
Purchase online at http://www.melamedia.com or
Download the form at www.melamedia.com/032806RegForm.pdf and fax it to 703.619-4912.