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Health Care Law Institute 2016: Emerging Challenges and Trends in Reimbursement, Enforcement, Compliance and other Hot Topics

 
Author(s): David J. Farber, Esther Scherb
Practice Area: Health Care
Published: Dec 2016
ISBN: 9781402428043
PLI Item #: 151074
CHB Spine #: M12

David Farber brings together the best of King & Spalding’s knowledge, combining his experience in both litigation and public policy to solve client needs. Having been trained as a litigator, Mr. Farber maintains a strong complex multiparty litigation practice, including serving as first chair in health care litigation, False Claims Act cases, and other commercial disputes. Mr. Farber also maintains a strong government advocacy practice before both the Congress and federal agencies, and  has  drafted  and  had passed legislation, as well as influenced and changed Agency policies, principally in the health care and insurance fields.

In his litigation practice, Mr. Farber began  his  career  working  on  environmental  and health and safety cases, including complex insurance coverage and trade secret matters. He has tried over 20 cases, ranging from expedited administrative law judge trials to a recent five-day broker malpractice case. He has also litigated False Claims Act and Trade Secret litigations. Mr. Farber has recently been involved in several international disputes, including international arbitrations and related litigation.

On the advocacy side, Mr. Farber’s work focuses on the health care and insurance industries. Clients often turn to him as the primary strategist and policy architect for a broad range of matters. Working with the Congress, the Executive (with particular focus on the Centers for Medicare & Medicaid Services and Food and Drug Administration) and academia, he  has successfully guided clients through the legislative enactment and the regulatory promulgation processes. He drafted, and had enacted, the SMART Act of 2012, which was the first major reform of the Medicare Secondary Payer system in over 30 years.

Mr. Farber excels at combining innovative legislative advocacy, regulatory change and litigation to help clients achieve solutions. His clients often comment on the unexpected and quick manner in which Mr. Farber is able to resolve disputes and obtain outcomes, using a combination of skills usually found across multiple specialists.

Finally, Mr. Farber has worked on a broad range of other client needs, ranging from representation of an international agricultural biotech foundation that has received the largest Gates grant given to an African  entity, to  his service  as personal  counsel to Secretary Jack Kemp from 1992 through his passing in 2009.

Awards & Recognition

  • Spirit of Community Action Award, the United Planning Organization (2005)

MATTERS

Representative Litigation Matters

  • Obtained successful result after five-day trial in broker malpractice litigation involving complex marine and general liability policies. OCI Chemical v. Aon Corporation (Sup.Ct. Ct 2008).
  • Enjoined state reimbursement rate reduction on behalf of Medicaid service providers, resulting in $20 million gain for clients and millions more for industry. Long Term Care Pharmacy Alliance v. Ferguson, 260 F.Supp.2d 282 (D. Mass 2003), rev’d on other grounds,362 F.3d 50 (1st Cir. 2004).
  • Litigated and successfully resolved trade secret, Lanham Act and misappropriation of business information claims involving recovery of forensic evidence wiped from opposing party’s computer. Winning Connections v. Chism,(D.D.C. 2005). Also prosecuted and defended numerous other trade secret cases to successful settlements, including Movado v. Gucci, (S.Ct. NY 2004); James Hardie v. Demey, (D.S.C. 2003); and Applied Discovery v. Bowne, (D.Wa. 2002).
  • Lead counsel in successful settlement of complex multiparty False Claims Act case establishing jurisdiction precedent on materiality standards and pleading requirements. United States, ex rel. Wilkins v. North American Constr. Corp., 173 F.Supp.2d 601, (S.D.Tex.2001).
  • Recovered looted funds on behalf of the Government of Rwanda following 1994 genocide: Rwanda v. Rwanda Working Group, 227 F. Supp.2d 45 (D.D.C. 2002), aff’d in part, 409 F.3d. 368 (DC Cir. 2005); Republic of Rwanda v. Uwimana (In re Uwimana), 255 B.R. 669 (D. Md. 2000); aff’d,274 F.3d 806, 811 (4th Cir.2001).
  • Lead counsel in successful settlement of complex, multiparty environmental insurance coverage litigation which set national precedent on significant coverage issue. Pittston Co. v. Allianz Ins. Co., 905 F. Supp. 1279 (D.N.J. 1995), reversed in part, 124 F.3d 508, 521 (3d Cir.1997).

Representative Advocacy Matters

  • Lead Counsel in enacting SMART Act of 2012 (112th Congress, H.R. 1845, Title II), in first major reform of Medicare Secondary Payer statute since 1980.
  • Succeeded in enactment of December 2007 MMSEA provision significantly advancing client’s Medicare Part B reimbursement strategy.
  • In 2006, led multi-firm advocacy team to reverse CMS coverage decision barring client’s flagship drug from Medicare Prescription Drug Program. As a result of intensive 45-day effort, the decision was reversed, drug was covered and shortly thereafter client sold company for over $3 billion.
  • Represented major pharmacy trade association in all aspects of advocacy, including enactment of provisions in Medicare Modernization Act of 2003, promulgation of CMS policies related to industry and representation before multiple state Medicaid programs on advocacy and litigation (and combined advocacy and litigation) issues.
  • Represented insurance trade association before Labor Department on promulgation of FLSA standards, and before numerous states on legislative issues (including resolution of complex litigation through legislative leverage).

PRACTICES

FDA & Life Sciences Health Govt Investigations

White Collar Defense & Government Investigations

Health IT and EHRs

Healthcare Industry

Healthcare Litigation

Government Advocacy & Public Policy

Domestic  Arbitration/ADR

Appellate, Constitutional and Administrative Law

International Arbitration

MEMBERSHIPS

District of Columbia Bar Association

American Health Lawyers Association

American Jewish Committee, President Washington Region (2011-13), Member National Board of Governors (2013- present), Comay Fellowship (2008)

Jewish Federation of Greater Washington, Member of the Board of Directors  (2008-present)

German-Israel Young Leaders Exchange, Bertelsmann Foundation Fellow (2007)

EDUCATION

 J.D., Georgetown University Law Center

B.A. Economics, New York University

ADMISSIONS

District of Columbia

New York Supreme Court of the United States

U.S. Court of Appeals for the Eleventh Circuit

U.S. Court of Appeals for the Fifth Circuit

U.S. Court of Appeals for the First Circuit

U.S. Court of Appeals for the Fourth Circuit

U.S. Court of Appeals for the Ninth Circuit

U.S. Court of Appeals for the Sixth Circuit

U.S. Court of Appeals for the Third Circuit

U.S. District Court for the District of Connecticut

U.S. District Court for the Western District of Michigan


Esther Scherb’s practice focuses on healthcare and regulatory matters, with an emphasis on Medicare, Medicaid and other government programs administered by the U.S. Department of Health and Human Services (HHS). She counsels clients on reimbursement and compliance issues faced by the healthcare and life sciences industries.

Dr. Scherb assists providers, medical device, pharmaceutical and biotechnology manufacturers, private equity firms, investment bankers and other industry groups in various matters, including development and implementation of comprehensive reimbursement strategies for new and existing technologies; reimbursement and compliance counseling; advocacy with the Centers for Medicare & Medicaid Services (CMS), Medicare Administration Contractors and third-party payors on coverage, coding, payment, enrollment and certification policies; representation in administrative and federal court litigation stemming from government audits and payment disputes; analysis and interpretation of regulatory risks and implications for investment, corporate mergers, acquisitions and affiliations; and compliance with government drug pricing programs, including pricing methodologies and reporting.

Dr. Scherb served with the HHS Office of the General Counsel. She represented the Health Care Financing Administration (now CMS) in all phases of litigation involving hospitals, clinics, physicians and other medical providers, and counseled the agency on Medicare policies, rulings and guidelines. She also represented HHS in a number of Medicare and Medicaid investigations and appeals.

Representative Matters

  • Developed reimbursement strategies for numerous medical device manufacturers positioning their new technologies for market launch and for other stages of the life cycle.
  • Provided strategic analysis of reimbursement landscape and healthcare regulatory developments to market investors and underwriters.
  • Provided regulatory counseling to medical device and pharmaceutical manufacturers on Medicare and other third-party payor billing issues.
  • Assisted medical device and pharmaceutical companies with successful applications for new and revised billing codes.
  • Assisted medical device companies with obtaining Medicare coverage for new and existing technologies.
  • Assisted numerous Medicare providers suppliers, such as major academic centers, national device companies and pharmacies, with preparation of responses to audit requests from the Office of Inspector General and Medicare administrative contractors.
  • Successfully represented manufacturers and providers before administrative adjudicators, resulting in the substantial reductions of Medicare overpayment liability and reversals of claims and cost report denials.

Previous Experience

  • U.S. Department of Health and Human Services, Office of the General Counsel, Health Care Financing and Civil Rights Divisions, General Attorney
  • Office of Technology Development of the National Cancer Institute, Special Assistant

Memberships and Affiliations

  • American Health Lawyers Association, Member
  • American Bar Association, Payment and Reimbursement Interest Group, former Vice-Chair
  • Dental Assisting National Board, former Chair of the Board of Directors

Practices

  • Regulatory and Public Policy
  • Food, Drug, and Device

Industries

  • Health Care
  • Life Sciences

Education

  • University of Richmond School of Law, J.D., 1987
  • Tufts University, D.M.D., 1978
  • Brooklyn College, B.S., 1975

Government Service

  • U.S. Department of Health and Human Services

Bar Admissions

  • District of Columbia Virginia