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Hot Topics in Health Care Law 2018


Speaker(s): Daniel Hettich, David J. Farber, Gary A. Heimberg, Jodi Daniel, Kathleen Blake, 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


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.


Tony Maida counsels health care and life sciences clients on government investigations, regulatory compliance, and compliance program development.  Having served as a government official, Tony has extensive experience in health care fraud and abuse and compliance issues, including the federal and state Anti-Kickback and Stark laws and Medicare and Medicaid coverage and payment rules. He represents clients in False Claims Act qui tam matters, government audits, civil monetary penalty and exclusion investigations, and CMS suspension, and revocation actions, negotiating and implementing Corporate Integrity Agreements, and making government self-disclosures. Tony also draws on his background in government investigations to assist clients in evaluating, developing and implementing corporate compliance programs.

Tony previously served as Deputy Chief of the Administrative and Civil Remedies Branch of the US Department of Health and Human Services Office of Inspector General where he represented the agency on investigating False Claims Act and civil monetary penalty cases, negotiating and monitoring Corporate Integrity Agreements, and defending exclusion appeals. While serving at HHS, Tony was a principal author of the OIG's current Self-Disclosure Protocol. He also has advised CMS on policy issues, including the Medicare Overpayment Rule and the creation of the Self-Referral Disclosure Protocol. 

Tony represents a wide variety of clients, including:

  • Hospitals and health systems
  • Professional services organizations and physician practice management companies, such as anesthesia, dentistry, dermatology, emergency medicine, oncology, primary care, radiology, and wellness practices
  • Pharmaceutical and medical device manufacturers and distributors
  • Long-term care, home health, hospice and other post/sub-acute providers
  • Pharmacies and pharmacy benefit managers
  • Dialysis providers
  • Laboratories
  • Ambulance companies
  • Health plans
  • Electronic health records and revenue cycle management vendors
  • Investors and other financial institutions that invest in and/or support the health care and life science industries

Tony writes and speaks frequently on health care regulatory topics and has lectured on health care fraud and abuse issues at Seton Hall Law School, Boston University School of Law, and American University Washington College of Law.

Prior to his government service, Tony represented hospitals and physician practices on health care regulatory and corporate compliance issues. During law school, Tony was the editor of the 2001 Symposium issues of the American Journal of Law and Medicine


Rujul Desai is Of Counsel at Covington & Burling LLP, where he advises clients on drug pricing, market access, reimbursement, strategic contracting, and regulatory solutions. He brings deep experience with biopharma, specialty pharmacy, and pharmacy benefit management (PBM) companies.

Mr. Desai has held a number of leadership roles in the biopharma, PBM, and specialty pharmacy industry, including with CVS Caremark, UCB, and most recently as Vice President at Avalere Health, a leading health care consulting firm. He has led engagements across a wide range of market access and reimbursement issues, including optimizing new product launches, pricing, PBM and payer formulary access, value-based contracting, distribution network design, patient access and hub services, affordability programs, e-prescribing, digital health, and the use of health economic data and modeling.

Mr. Desai was a Captain in the Medical Services Corps of the U.S. Army Reserves, and served in active duty in Iraq.

Mr. Desai is a member of the Bar of Texas. District of Columbia bar application is pending; supervised by principals of the firm.