Overview

Health care regulatory, reimbursement, and compliance attorney Rob Wanerman combines a practical approach to solving problems with a deep understanding of the underlying policies reflected in statutes, regulations, and guidances that affect clients.

They value Rob’s ability to break down complex concepts into plain English, spot issues that they may have not considered, and understand both clinical and legal issues. His clients include medical device manufacturers, diagnostics manufacturers and suppliers, biotech companies, companies integrating artificial intelligence into diagnostics and treatments, Medicare and Medicaid providers (hospitals, home health, hospice), precision medicine/genomics companies, and health care startups.

Rob has extensive experience advising on administrative law matters, including hearings, rulemaking, and the application of regulations to client operations as well as  Medicare regulations and compliance. In addition, Rob works with manufacturers and innovators on coverage, coding, and reimbursement for new technologies and related procedures. Clients also rely on Rob for advice on matters arising under the False Claims Act, clinical research rules, grant administration rules, the Anti-Kickback Statute, the Stark Law, HIPAA, and EMTALA. In addition, Rob represents clients in government audits, investigations, litigation, and appeals involving the Medicare and Medicaid programs.

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For more than a decade, Rob served as an assistant counsel in the HHS Office of the General Counsel, representing the Centers for Medicare & Medicare Services (CMS) and the Office of Inspector General (OIG), among other agencies. Clients benefit from his insider’s knowledge of these agencies and his ability to understand the regulators’ viewpoint.

Rob helps clients stay compliant with all relevant laws by conducting training sessions for clients’ boards and staff. For non-U.S. health care companies, he provides advice on strategies for U.S. market entry.

A frequent speaker and author, Rob has published book chapters on coverage, coding, and reimbursement; federal regulation of medical research; fraud and abuse; and the corporate practice of medicine. Professional and medical journals have featured his articles on health regulatory matters.

Rob has been a faculty member for 10 years at a major biotech conference and is a guest lecturer on health care law at law and business schools. His pro bono work includes serving as counsel and board member at The Ivymount School, a school in Maryland that specializes in programs for children and young adults with special needs, and he has earned the high honors designation in the Capital Pro Bono Honor Roll.

Publications

  • Biotechnology Entrepreneurship: Starting, Managing, and Leading Biotech Companies, 2nd ed., 2020 (co-author of chapters on Biotechnology Product Coverage, Coding, and Reimbursement Strategies and Artificial Intelligence in Biotechnology: A Framework for Commercialization)
  • Pharmaceutical and Medical Device Compliance Manual, 2nd ed. 2019 (co-author of a chapter on coverage and reimbursement)
  • CMS Coverage Decision May Raise Barriers to Precision Cancer Medicine and Reduce Incentives for Evidence Development, Health Affairs Blog, 2018
  • Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing, 2nd ed., 2015 (co-author of chapters on Federal Regulation of Clinical Research and Avoiding Fraud and Abuse Penalties and Sanctions)
  • Biotechnology Entrepreneurship: Starting, Managing, and Leading Biotech Companies, 2014 (co-author of a chapter on Biotechnology Product Coverage, Coding, and Reimbursement Strategies)
  • 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

  • Reimbursement and Pricing Strategies, BIO International Convention, Biotechnology Entrepreneurship Boot Camp, 2011 – present
  • Innovator Meets Regulator: The Challenge for Artificial Intelligence in Biotech, Biotech Week Boston, 2019
  • Navigating the Regulatory Landscape for New Medical Devices, Association of University Technology Managers, 2014 – 2015
  • An Overview of Federal Health Care Programs for  Drug and Device Manufacturers, Seton Hall Health Care Compliance Certification Program, 2014 – 2015
  • Billing Compliance Master Class, MAGI Clinical Research Conference, 2014
  • Strengthening Compliance and Enforcement: The Challenges of Globalization, Johns Hopkins Carey Business School (Dec. 2, 2011)
  • Coverage, Coding, and Payment for Procedures, Devices, Drugs, and Diagnostics, Johns Hopkins Carey Business School, (Sept. 27, 2010, Sept. 13, 2011, and Sept. 2012) (Sept. 2013)
  • Inside the OIG's Toolbox, MAGI Clinical Research Conference, 2009 – 2013 (Miami, May 31, 2009) (Boston, MA, May 23, 2010) (Philadelphia, May 22, 2011) (DC May 20, 2012)(Boston, May 6, 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 (June 16, 2008, and June 20, 2011)
  • U.S. Drug and Device Commercialization Issues: Coverage, Coding, and Payment, ILSI-Biomed (Tel Aviv, Israel) (June 4, 2007, and May 27, 2008)
  • An Overview of Federal Health Care Programs for Drug and Device Manufacturers, Seton Hall Health Care Compliance Certification Program, Washington, DC (June 16, 2008)
  • Managing Compliance and Fraud Risks in Grant and Sponsor-Funded Clinical Research, Greater New York Hospital Association, June 18, 2007
  • Coverage, Coding and Reimbursement in the U.S., Health Care Technological Innovation: From Idea to Commercialization, Tel Aviv University Faculty of Management (May 25, 2007)
  • Current Issues With The Medicare Modernization Act, Seton Hall Health Care Compliance Certification Program (March 5, 2007)
  • Payment, Reimbursement, and Cost Issues Associated with Implementation and Delivery of Genetic Tests for Rare Diseases, Centers for Disease Control and Prevention (Sept. 26, 2005)
  • Negotiating and Drafting Clinical Trial Agreements, Health Care Compliance Association Research Compliance Conference, Las Vegas (Nov. 7, 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, Cambridge, MA (May 21, 2004)
  • Clinical Research Compliance, American Health Lawyers Fraud & Compliance Forum, Washington, DC (Sept. 21, 2003)
  • Medicare Appeals from A to B, American Health Care Association Annual Meeting (Oct. 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, Dallas, Texas (Feb. 13, 2002)
  • Government Regulation Update, Health Care Financial Management Association, 2001
  • Examination of a Research Compliance Plan: Is It Healthy?, Medical Research Summit, Washington, DC (March 20, 2001)

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Focus Areas

Experience

  • Successfully challenged, on behalf of a Medicare beneficiary and the global pharma manufacturer of the products she used, an interpretation by CMS of the Medicare coverage statute. Rob prevailed in the district court and in the U.S. Court of Appeals for the DC Circuit. As a result of this victory, the beneficiary gained access to needed medicines and the manufacturer increased its Medicare reimbursement.
  • Sought and obtained for a biotech company with a novel product a favorable Advisory Opinion from the HHS Office of Inspector General that the clinical trial arrangements with hospital sites would not violate the Anti-Kickback Statute. Rob confirmed that specific waivers of clinical trial costs are not illegal remuneration.
  • Defended a genetic diagnostics laboratory in False Claims Act whistleblower litigation. Rob persuaded the district and appellate courts that there was a complete defense to the allegations based on the government’s knowledge. The appellate court agreed with other circuits in applying the government knowledge defense.
  • Represented a long-term care and home health company against potential exclusion from the Medicare program, along with potential civil penalties. Rob conducted an intensive review of the government’s allegations of noncompliance, and drafted and implemented a plan of correction. The client avoided exclusion from Medicare and Medicaid.
  • Persuaded CMS that a multinational medical device company’s device was a covered prosthetic. Rob also persuaded CMS to revise its coverage policies to include the device and to withdraw a proposed regulation that would have excluded the device from Medicare coverage. Because of this success, Medicare beneficiaries obtained access to a new technology for deafness, and the company was able to expand its market.
  • Represented a precision cancer diagnostics laboratory on successful challenges to denials of Medicare reimbursement for an oncology diagnostic. Rob obtained reversals of unfavorable coverage determinations, and successfully represented the laboratory in litigation challenging final adverse hearing decisions. A district court confirmed that HHS must review an entire record when making hearing decisions. The company was then able to obtain significant Medicare reimbursement.

Credentials

Education

  • University of Chicago (Certificate in Healthcare Informatics, 2019)
  • Columbia University (M.P.H., 1995)
    • School of Public Health
  • New York Law School (J.D., 1985)
  • University of Chicago (A.B., 1979)
    • Economics

Bar Admissions

Court Admissions

Professional & Community Involvement

  • American Health Lawyers Association
  • Journal of Commercial Biotechnology,Editorial Advisory Board

Media

Events

Insights

Insights

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