The development of new drugs and devices is one of the highest compliance risk areas for the healthcare industry today. Much is at stake for the developers, the providers who perform the research, as well as for the patients waiting for help from industry innovation. Most recently, the industry has seen increased enforcement of clinical trials research regulatory rules, particularly in billing compliance.
Join us for a free educational webinar with research compliance experts from Sonnenschein, Nath & Rosenthal and Meade & Roach. The presenters will offer practical guidance and discuss case study examples that illustrate:
- How to bill for research patients under Medicare Part C
- How to bill for research patients under Medicare Part D
- False Claims Act Amendments and the implications for historical payments
- OHRP Investigations for 2009 and beyond: Important liability implications for the Institutional Official and Human Research Protections Administrator
- The importance of having an official "Research Compliance Program" if there is any research done at your organization
- Live Q&A with the presenter(s)
Who Should Attend
- CFO, CEO
- Chief Compliance Officer
- Director of Internal Audit
- Chief Risk Officer
- Director of Risk Management
- Director of Legal/Regulatory Counsel
About the Presenter
F. Lisa Murtha, J.D., CHC, Partner: Lisa has over 22 years of experience in working with provider organizations, universities and life sciences organizations in a variety of compliance areas including clinical research compliance, corporate governance, compliance program design and effectiveness and much more. Lisa speaks at national events frequently on compliance and clinical research topics and she has published numerous articles, book chapters and books on these topics.
Andra M. Popa, JD, LLM, Meade & Roach: Andra is a consultant with Meade & Roach, LLP and an associate with Aegis Compliance & Ethics Center, LLP. She focuses her consulting work on Medicare/ Medicaid reimbursement, human participant protection program operations and structure, general compliance program development, educational program development, and the creation of electronic compliance libraries and tools. She is experienced with developing Medicare coverage analyses for research studies for a variety of health care entities. She also has experience as the Assistant Director of Quality Assurance/ Quality Improvement in the office for the protection of research participants of a large university with a medical center in Chicago, Illinois. Previously, Andra was an Associate Writer with CCH, Inc./ Wolters Kluwer for its health care compliance portfolio, where she updated chapters of the book Medicare Explained 2006, and updated chargemaster edits, changes to prospective payment systems, cost reporting standards, and DRG/APC valuation methods. Andra also served as a Billing and Reimbursement Analyst for an anesthesiology group for over five years. |
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