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Hot Topics in Health Care Law 2019


Speaker(s): Carol Vargo, David J. Farber, Eugenia E. Pierson, Greg Radinsky, Jacob T Elberg, Jeff I Davis, Kristin Roshelli, Laura F. Laemmle-Weidenfeld, Olivia Jahn, Rujul Desai, Shanya J. Dingle, Tony Maida
Recorded on: Dec. 11, 2019
PLI Program #: 253929

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


Carol Vargo is Director of Physician Practice Sustainability in the AMA Physician Satisfaction and Practice Sustainability Strategic Initiative Group.  She directs AMA strategies to support sustainable physician payment and delivery reforms and directs external partnerships with hospitals, health systems, health plans, employers, patients and other key stakeholders to advance implementation and adoption of new value-based models.  Carol is a graduate of Miami University in Oxford, Ohio, with a B.A. in Communications, and a recipient of a Masters in Health Sciences in health policy and administration from the Johns Hopkins University Bloomberg School of Public Health. 


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.


Eugenia Pierson assists a wide range of clients in the development and implementation of legislative and regulatory strategies. As senior policy advisor and head of healthcare legislative advocacy, her work focuses on health policy issues related to hospital systems, providers, consumers and manufacturers, including Medicare coverage and reimbursement, Medicaid, the State Children's Health Insurance Program, public health, insurance coverage, delivery system reform, health information technology and implementation of national health care reform. She began her career on Capitol Hill as a staff member of the House Energy and Commerce Committee's Health Subcommittee. She later served as the former chair of an Am Law 100 firm's Healthcare Policy practice group.


Greg Radinsky is Senior Vice President and Chief Corporate Compliance Officer for Northwell Health in New York, the largest health system and private employer in New York.  He is responsible for overseeing the compliance programs of its hospitals, skilled nursing facilities, home health agencies, hospice, laboratory, research and other related entities.

Immediately prior to joining Northwell Health, Mr. Radinsky had been a Vice President and Assistant General Counsel for Broadlane (now Vizient), a leading healthcare procurement company.  He also served as a Vice Chair to the Healthcare Group Purchasing Industry Initiative, an organization dedicated to promote and monitor best ethical business practices in the healthcare group purchasing industry.  Before that Mr. Radinsky was an attorney for Medtronic’s Cardiac Surgery division.  He was responsible for managing compliance, fraud and abuse and corporate issues. Additionally, he also held marketing and consulting positions at Medtronic. 

Mr. Radinsky began his career as a fraud and abuse attorney for the Office of Inspector General for the U.S Department of Health and Human Services (OIG) where he coordinated with the U.S. Department of Justice, state attorneys general, Centers for Medicare & Medicaid Services (CMS) and other government agencies on civil and criminal healthcare fraud matters.  He was selected to receive the prestigious OIG Exceptional Achievement Award, OIG Cooperative Achievement Award, and the United States Department of Health and Human Services Regional Director’s Leadership Award for his work. 

He also has published several articles on healthcare legal and compliance topics and has given many presentations on developing and implementing corporate compliance programs.  Mr. Radinsky was selected as one of the “Attorneys Who Matter” in the Ethics & Compliance category by the Ethisphere® Institute in 2014, 2015 and 2016. He also received the Fellow of the Trust award by Health Ethics Trust.

Mr. Radinsky received his M.B.A. from the Kellogg School of Management, his J.D., magna cum laude, from Saint Louis University School of Law, and his B.A., magna cum laude, from Tufts 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).


Jeff Davis is Of Counsel in Baker Donelson's Washington, D.C., office and is a Senior Advisor in the firm’s Government Relations and Public Policy Group.

Mr. Davis provides clients with health care regulatory counsel on issues affecting health care providers, including Medicare and Medicaid billing and reimbursement. He assists hospitals, pharmacies, other health care providers, and vendors on issues related to the federal 340B drug pricing program, including enrollment; contracting; audits; compliance with 340B, Medicare, and Medicaid requirements; and self-disclosures. He also provides clients with strategic advice related to public policy issues before the U.S. Congress and the administration, including drug pricing and non-profit hospital issues.

Prior to joining the Firm, Mr. Davis served as vice president and legislative and policy counsel for 340B Health, a nonprofit organization of more than 1,400 hospitals and health systems participating in the 340B drug pricing program. During his more than seven years with 340B Health, he provided hospitals with technical assistance on 340B, Medicare, and Medicaid program compliance issues, oversaw research and policy efforts, and helped lead the government relations team in their work to educate members of Congress and their staff on the importance of the 340B program to hospitals and their patients.

Mr. Davis previously served as the health care legislative assistant for U.S. Representative Shelley Berkley (D-NV). Mr. Davis received his law degree from Boston University School of Law and is admitted to practice law in the District of Columbia and Maryland.


Kristin Roshelli is a Senior Associate in King & Spalding’s Houston Healthcare practice.  Her practice focuses on representing health care providers and suppliers in a variety of regulatory, compliance, and transactional matters.  Most recently, she helped with the formation of two new health systems in Louisiana and East Texas.

Prior to entering the legal field, Kristin served as a nurse in the United States Air Force and worked in the general counsel’s office of a large academic medical center.  Following law school, she clerked for the Honorable P. Kevin Castel for the United States District Court for the Southern District of New York.

Outside of work, Kristin is involved in advocating for issues important to veterans and is a mom to two young children. 


Olivia J. Jahn is Corporate Counsel at Flatiron Health, a data-driven health tech company that is focused on accelerating cancer treatment and research by learning from the experience of every patient. Previously, she practiced as an associate at McDermott Will & Emery, where she provided transactional, regulatory, and compliance advice to clients across the health care industry. Olivia also serves on the Junior Advisory Board of Her Justice, a non-profit organization that provides pro bono legal services to women living in poverty in NYC. Olivia received her B.S.B.A. from Washington University in St. Louis and her J.D. with high honors from the George Washington University Law School.


Shanya J. Dingle is Special Counsel in the White-Collar Defense and Investigations Group of Covington & Burling LLP.  A former federal prosecutor, Ms. Dingle has extensive experience representing major companies in civil and criminal investigations by the Department of Justice and other federal agencies concerning allegations of misconduct and violations of the False Claims Act and Anti-Kickback Statute.  In particular, Ms. Dingle has developed expertise in handling matters involving pharmaceutical sales and marketing, as well as digital health.  During her six years as a prosecutor, she prosecuted and investigated a range of complex financial crimes.  Ms. Dingle obtained her bachelor’s degree and J.D. from Harvard College and Harvard Law School.


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.