Biography

ROBERT E. WANERMAN is a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office of Epstein Becker Green. His practice concentrates on regulatory, reimbursement, and compliance matters affecting health care manufacturers, service providers, and investors in health care organizations. He has extensive experience counseling clients in matters arising under the Medicare and Medicaid programs, administrative law and procedure, the False Claims Act, clinical research rules, grant administration rules, the Anti-Kickback and Stark laws, HIPAA, and EMTALA.

Mr. Wanerman:

  • Advises clients in connection with coverage, coding, and reimbursement for medical technologies under Medicare, Medicaid, and commercial health plans
  • Provides counsel on administrative law issues affecting health care manufacturers, suppliers, and providers, and represents clients in administrative hearings and appeals
  • Represents clients in government audits, investigations, and litigation arising under the Medicare and Medicaid programs and under the False Claims Act, including negotiating settlements and corporate integrity agreements
  • Counsels manufacturers and providers on clinical research contracting and compliance
  • Develops and implements compliance programs and policies for medical device and pharmaceutical manufacturers, hospitals, academic medical centers, and long-term care facilities

Mr. Wanerman is a guest lecturer at the Johns Hopkins Carey Business School, Discovery to Market Program. He regularly gives presentations at industry conferences and is consistently ranked by participants as a top speaker.

Outside of the office, Mr. Wanerman is the Vice-President of The Ivymount Foundation, which provides financial support to educational programs for children with developmental delays, speech/language deficits, learning disabilities, health impairments, and autism/PDD.

Publications:

  • Pharmaceutical Law: Regulation of Research, Development, and Marketing, 2008 and annual supplements (co-author of chapters on Federal Regulation of Clinical Research and Avoiding Fraud and Abuse Penalties and Sanctions)
  • Clinical Research Compliance Manual, 2006 (co-author of chapter on Human Subject Protections in Clinical Research)
  • Clinical Research: Federal Rules and Regulations Manual, 2002
  • The Basics of Coverage, Coding, and Reimbursement, Journal of Commercial Biotechnology, 2012
  • It Ain't Over Till It's Over: Rights and Obligations When a Clinical Trial Ends, 5 BNA Medical Research Law & Policy Report 439, 2006
  • HHS Proposes New Research Misconduct Procedures, 3 BNA Medical Research Law & Policy Report 536, 2004
  • The EMTALA Paradox, Annals of Emergency Medicine, 2002;40:464-69, 2002
  • OHRP Clinical Trial Oversight Guidance Fosters IRB Introspection, Policy Changes, 1 BNA Medical Research Law & Policy Report 147, 2002
  • Hidden Fraud and Abuse Risks in Practice, 50 AAOS Bulletin, December 2002
  • Conflicts of Interest in Biomedical Research: Managing Risks in an Imperfect World, Food and Drug Law Institute Update, March/April 2002

Seminars:

  • Coverage, Coding, and Payment for Procedures, Devices, Drugs, and Diagnostics, Johns Hopkins Carey Business School, 2011 — 2013
  • Inside the OIG's Toolbox, MAGI Clinical Research Conference, 2009 — 2013
  • Reimbursement and Pricing Strategies, BIO International Convention, Biotechnology Entrepreneurship Boot Camp 2011 — 2013
  • Coverage, Coding, and Payment for Devices, Drugs, and Diagnostics: Taking Your Product to Market, American University Washington College of Law Health Law and Policy Institute, 2008 and 2011
  • U.S. Drug and Device Commercialization Issues: Coverage, Coding, and Payment, ILSI- Biomed (Israel), 2007 — 2008
  • An Overview of Federal Health Care Programs for Drug and Device Manufacturers, Seton Hall Health Care Compliance Certification Program, 2008
  • Coverage, Coding and Reimbursement in the U.S., Health Care Technological Innovation: From Idea to Commercialization, Tel Aviv University Faculty of Management, 2007
  • Current Issues With The Medicare Modernization Act, Seton Hall Health Care Compliance Certification Program, 2007
  • Negotiating and Drafting Clinical Trial Agreements, Health Care Compliance Association Research Compliance Conference, 2004
  • Paying for New Cardiac Marker Tests: If You Build It, What Will They Pay?, 26th Annual Arnold O. Beckman Conference, American Association for Clinical Chemistry, 2004
  • Clinical Research Compliance, American Health Lawyers Fraud & Compliance Forum, 2003
  • Medicare Appeals from A to B, American Health Care Association Annual Meeting, 2003
  • The Emergency Medical Treatment and Active Labor Act, George Washington University Department of Emergency Medicine Grand Rounds, 2003
  • Current Legal Pitfalls in Orthopaedic Practice, American Academy of Orthopaedic Surgeons Annual Meeting, 2002
  • Government Regulation Update, Health Care Financial Management Association, 2001
  • Examination of a Research Compliance Plan: Is It Healthy?, Medical Research Summit, 2001

Education

  • Columbia University (M.P.H., 1995)
    • School of Public Health
  • New York Law School (J.D., 1985)
  • University of Chicago (A.B., 1979)
    • Economics

Court Admissions

  • Supreme Court of the United States
  • U.S. Court of Appeals for the District of Columbia Circuit
  • U.S. Court of Appeals for the First Circuit
  • U.S. Court of Appeals for the Second Circuit
  • U.S. Court of Appeals for the Tenth Circuit
  • U.S. District Court, District of Columbia
  • U.S. District Court, Eastern District of New York
  • U.S. District Court, Northern District of New York
  • U.S. District Court, Southern District of New York

Bar Admissions

  • District of Columbia
  • New York

Memberships

  • American Health Lawyers Association
  • BNA Medical Research Law & Policy Report, Editorial Advisory Board