Coping With The CMS Billing Rules for Clinical Research

CMS issued modified guidance in July, 2007 for reimbursement for clinical research under Medicare that creates new opportunities, but also requires researchers to a fresh look at how they should design their studies and how they should draft their protocols. The Clinical Research Policy attempted to expand coverage for Medicare beneficiaries but it has also created some potentially gray areas as well.

Billing for clinical trial services continues to be fraught with substantial confusion and risk for any organization conducting clinical research. This is particularly true in the wake of CMS's formal decision on Oct. 17 to not issue further changes.

To help healthcare researchers understand and take advantage of the new policy, Drug & Biologic Guidance Watch and Health Information Privacy/Security Alert are sponsoring a 90-minute audio seminar:

Coping With The CMS Billing Rules for Clinical Research

Participants will be briefed on:

• The scope of clinical trials covered under the policy;
• The definition of "routine cost" and "usual patient care";
• The extent to which Medicare will go in paying for investigational clinical services;
• The extent to which Medicare will pay for research services under its Coverage with Evidence Development (CED) policies;
• Procedures to consider to avoid misbilling;
  and much more.

The Faculty
The seminar features an outstanding faculty, including key players in the settlement negotiations between Rush University and the federal government over clinical trial billing in 2005.

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

Who Should Attend

• Clinical Investigators and Study Coordinators
• Research Managers
• Research Grant Managers
• Institutional Review Boards
• Contract Research Organizations
• Pharmaceutical Research And Marketing Professionals
• Medical Device Manufacturers
• Biologics Manufacturers
• Medicare Billing Professionals
• Healthcare Attorneys
• Healthcare Consultants

What Is An Audio Seminar?

An audio seminar is a live event that includes session handouts, a Q&A period and access for an unlimited number of participants at each call-in site.

Ordering
CD and Course Materials are available for $270 - a wonderful tool to conduct training at any time.

Download the form at http://www.melamedia.com/11.15.07.CD.Order.Form.pdf.

or vist www.melamedia.com to order online and view other research-related seminars offered by Melamedia..

Contact: Dennis Melamed
703.704.5665
dmelamed@melamedia.com