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Hot Topics in Health Care Law 2018


Speaker(s): Daniel Hettich, David J. Farber, Esther Scherb, Gary A. Heimberg, Jacob T Elberg, Jodi Daniel, Kathleen Blake, Laura F. Laemmle-Weidenfeld, Paul L Uhrig, Rujul Desai, Thomas Gustafson, Tony Maida, Valda Clark Christian
Recorded on: Dec. 12, 2018
PLI Program #: 220452

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


Gary Heimberg’s practice focuses on public policy and government affairs matters for pharmaceutical and consumer health care clients. He has substantive knowledge of the current legislative and policy issues facing the pharmaceutical industry, including in the areas of intellectual property, OTC medicines, vaccines, biodefense, and FDA reform. Mr. Heimberg has also facilitated the implementation of internal policies and procedures to adhere to federal compliance requirements.

Mr. Heimberg’s pharmaceutical industry experience spans all spheres, including in-house, trade association, government and private practice positions. Prior to joining Covington, he served as the director of federal government relations for a major pharmaceutical company, as vice president of federal affairs for a major industry trade association, as a staff member with and on the floor of the U.S. Senate, and in private practice with another international law firm.


Kathleen Blake, MD, MPH, is Vice President, Healthcare Quality at the American Medical Association, working to ensure that physicians have the information and tools necessary to successfully participate in new payment programs. She is a member of AMA senior management’s Payment and Delivery Reform Task Force. From April 2013 until April 2016, Dr. Blake was Executive Director of the PCPI® which includes among its activities the National Quality Registry Network™ (NQRN™). In that capacity Dr. Blake was responsible for ensuring the successful execution of all components of the PCPI strategic plan and the integrity of its measure portfolio, including oversight of PCPI performance measure-related activities.

Dr. Blake served as Co-Chair of the HIT Policy Committee of the Office of the National Coordinator for Health Information Technology until April 2017 and previously served as co-chair of its Quality Measures Task Force. She is a member of the Governing Committee of the National Evaluation System for health Technology (NEST) coordinating center, an FDA-funded public private partnership hosted by the Medical Device Innovation Consortium (MDIC). She has previously represented the Heart Rhythm Society (HRS) in the AMA House of Delegates and the PCPI and on the PCPI Work Group on congestive heart failure performance measures. As chair of the HRS Health Policy Committee, she led a team of physician volunteers and staff to address policy issues at the federal level and was a Founding Co-Chair of the Society’s Measure Development Task Force.

Prior to coming to AMA, Dr. Blake was Senior Research Director at the Center for Medical Technology in Baltimore, Maryland, overseeing Public-Private Partnerships, Policy and Education and serving as an advisor to two national clinical registries. Dr. Blake is a clinical cardiac electrophysiologist who received her medical degree from the University of Chicago, followed by post-doctoral training in internal medicine and cardiovascular diseases at Stanford University. From 1988 until 2011, Dr. Blake practiced at the New Mexico Heart Institute, where she also served as President. In 2011, she earned a Master of Public Health degree from the Johns Hopkins Bloomberg School of Public Health. She is a part-time member of the Johns Hopkins University medical faculty.


Paul Uhrig is the Chief Administrative, Legal and Privacy Officer for Surescripts.  He is responsible for a number of critical corporate functions, including governmental, regulatory, and policy affairs; legal affairs; privacy; security; internal audit; and certification compliance.

Prior to joining Surescripts in 2006, Mr. Uhrig represented Surescripts since its inception as its outside general counsel while at Akin Gump Strauss Hauer & Feld.

Mr. Uhrig works to bring change to the healthcare industry and drive interoperability outside of his role at Surescripts by serving as the Chairman of the Board of Directors of DirectTrust, as the Vice-Chairman of the Board of Directors of the Sequoia Project, and as a member of the Board of Directors of Enli Health Intelligence, the eHealth Initiative, and the eHealth Initiative Foundation.

Mr. Uhrig received his law degree from the American University, Washington College of Law, and his Bachelors of Arts in Economics from The University of Notre Dame.


Thomas Gustafson, Ph.D., is Senior Policy Advisor at Arnold & Porter Kaye Scholer, where he concentrates on health care policy and reimbursement issues.  He spent 32 years at the Department of Health and Human Services, in the Office of the Assistant Secretary for Planning and Evaluation and in the Centers for Medicare & Medicaid Services, where he held several executive posts responsible for Medicare and Medicaid legislation, strategic planning, research and demonstrations, and development and implementation of regulations.

From 2003 to 2007, Dr. Gustafson served as Deputy Director of the Center for Medicare Management (CMM), which coordinated the fee-for-service portion of the Medicare program and set payment rates for more than a million providers.  He supervised coding and payment policies affecting approximately $300 billion in Medicare spending on hospitals, physicians, nursing facilities, home health agencies, and other providers.  He led the development and introduction of the hospital outpatient prospective payment system and major improvements in Medicare’s other payment policies and systems.  He oversaw a sweeping reform, intended to improve accountability and efficiency, of Medicare’s administrative structure for paying claims.  In 2006-2007, he served as Acting Director of the CMM.

Since joining Arnold & Porter Kay Scholer in 2008, Dr. Gustafson has advised health-care providers, device and pharmaceutical manufacturers, and trade associations on a wide array of issues, including physician, outpatient hospital and end-stage renal disease reimbursement systems; accountable care organizations; laboratory coverage, coding and payment; and launch and reimbursement issues for devices and pharmaceuticals.

A native of Maine, he is a graduate of Williams College and holds a Ph.D. in Economics from Yale University.


Drawing on her extensive experience defending clients against health care fraud enforcement actions, Laura Laemmle-Weidenfeld also provides practical compliance advice on Medicare and Medicaid fraud and abuse issues. She has defended against numerous investigations and litigation brought by the Department of Justice (DOJ), various U.S. Attorneys offices, the Department of Health and Human Services Office of Inspector General (HHS-OIG), state attorneys general, and other state and federal agencies. Laura also helps her clients navigate challenging compliance issues, including analyzing arrangements under the Stark Laws and Antikickback Statute, conducting internal investigations, and preparing self-disclosures. She has represented a broad spectrum of health care providers, including hospitals and health systems, home health care agencies, telehealth providers, physician practices, clinical laboratories, post-acute care providers, and pharmacies, as well as pharmaceutical and medical device manufacturers.

Earlier in her career, Laura served as a trial attorney in the Frauds Section of the DOJ's Civil Division, where she conducted health care fraud investigations and litigation matters brought under the False Claims Act (FCA) and its whistleblower (or qui tam) provisions. While at the DOJ, she focused largely on FCA matters alleging violations of the Antikickback Statute; Stark Laws; and Federal Food, Drug, and Cosmetic Act.

An active member of the American Health Lawyers Association (chair, Fraud and Abuse Practice Group, 2014-2017), American Bar Association, BNA's Medical Devices Law & Industry Report advisory board, and Law360's health editorial advisory board, Laura frequently speaks and writes on health care fraud issues.

Laura received her J.D. from Georgetown University Law Center and her undergraduate degrees from Northwestern University.


Jake Elberg is an Assistant U.S. Attorney at the U.S. Attorney’s Office for the District of New Jersey.  As Chief of the Office’s Health Care & Government Fraud Unit for five years, Mr. Elberg has supervised a team of 15 AUSAs and directed all of the Office’s criminal and civil investigations and prosecutions of health care fraud offenses, including investigations and prosecutions of fraud against the government and private health insurance plans, illegal kickback schemes, violations of the Federal Food, Drug & Cosmetic Act, and the improper diversion of prescription drugs, as well as all health care-related actions brought by the Office under the False Claims Act.  In addition, Mr. Elberg has supervised and directed investigations regarding Foreign Corrupt Practices Act violations, as well as fraud against certain other government agencies and programs.

In 2013, Mr. Elberg was awarded the Department of Justice’s Executive Office of U.S. Attorneys Director’s Award for Superior Performance as an AUSA for his investigation and prosecution of Maxim Healthcare Services, et al., which resulted in a recovery of $150 Million (the largest ever in a home healthcare case), as well as the felony conviction of nine individuals in six states, including three senior executives of one of the nation’s largest home healthcare companies.

In 2018, Mr. Elberg was awarded the Health & Human Services Office of Inspector General Award for Fighting Fraud, Waste, and Abuse for leading the investigation and prosecution of Biodiagnostic Laboratory Services, which resulted in 53 convictions, including 38 physicians – the largest number of medical professionals ever prosecuted in a bribery case.

Mr. Elberg is also an Adjunct Professor at the Seton Hall University School of Law, where he teaches a course on Health Care Fraud and Corruption.

Mr. Elberg joined the U.S. Attorney’s Office in 2007.  Prior to joining the US Attorney’s Office, Mr. Elberg was an associate at Dwyer & Collora LLP (now Hogan Lovells) in Boston, where his areas of practice included white collar criminal defense, internal corporate investigations, and general commercial litigation.

Mr. Elberg received his JD in 2003 from Harvard Law School, graduating magna cum laude, after having received his BA in 2000 from Dartmouth College, from which he graduated cum laude and with honors.  After graduating law school, Mr. Elberg served as a law clerk to the Honorable Nancy Gertner (District of Massachusetts).


Rujul Desai, Vice President, advises clients on market access, reimbursement, strategic contracting and regulatory solutions.  He applies his unique combination of experience in specialty pharmacy, biopharma, PBM, legal and regulatory services.  Prior to joining Avalere, Rujul has held a number of leadership roles in the specialty industry, including at CVS Caremark, UCB, and Theracom.  He was also the founder of a specialty hub services company supporting biopharma products.  Rujul has significant health law experience, including practicing at the law firm of K&L Gates.  Rujul holds a JD from University of Houston and a BA from Rutgers University.  He is a combat veteran of the Global War on Terror, U.S. Army, Medical Service Corps, Captain (Ret.).