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Health Care Law Institute 2017: The New Challenges Facing Providers -- Reimbursement, Enforcement, Compliance, and Other Hot Topics

Speaker(s): Christopher P. Kenny, David J. Farber, Donald A Romano, Gary A. Heimberg, Jacob T Elberg, Jodi G. Daniel, Kathleen Blake, Laura F. Laemmle-Weidenfeld, Laurence J. Freedman, Paul L Uhrig, Rujul Desai, Thomas Gustafson
Recorded on: Dec. 14, 2017
PLI Program #: 186641

Chris Kenny specializes in advising healthcare providers and the healthcare industry. As a partner in our Healthcare practice, Chris provides strategic payment and compliance advice to healthcare providers participating in Medicare, Medicaid and commercial insurance plans.  Chris has twice been recognized by Chambers USA as a leading healthcare lawyer and for being “very responsive and extremely knowledgeable” in service to his clients.

With in-depth knowledge of payment systems and regulations, Chris advises health systems in navigating the Medicare provider-based regulation, the 340B Drug Pricing Program, reimbursement for organ acquisition and nursing and allied health education, and innovative payment models.

Applying his regulatory and reimbursement experience, Chris represents providers in False Claims Act investigations by the U.S. Department of Justice. He also represents hospitals in Medicare payment litigation, and before Congress and the administrative branch.

He strives to provide creative, proactive advice in an ever-changing healthcare regulatory environment, and to vigorously defend his clients’ positions in payment disputes and government investigations.

A member of the Healthcare Financial Management Association and the American Health Lawyers Association, Chris regularly speaks and writes on reimbursement and compliance issues. He is the co-editor of the Reimbursement Advisor, the leading national healthcare reimbursement publication, and serves as co-editor of our firm’s award-winning Health Headlines, a weekly newsletter summarizing healthcare law and policy developments.

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)


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).


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


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)


 J.D., Georgetown University Law Center

B.A. Economics, New York University


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

Donald H. Romano is Of Counsel to Foley & Lardner LLP, in the firm’s Washington D.C. office.  He counsels clients on regulatory compliance matters, particularly those pertaining to the Anti-Kickback Statute, the physician self-referral statute (Stark Law), HIPAA, and the Medicare enrollment regulations.  He also advises hospitals and other providers and suppliers on Medicare reimbursement issues.  Prior to joining Foley & Lardner LLP, Mr. Romano was a partner in another D.C. based law firm, and prior to that he had over 25 years of experience in the Department of Health and Services, including as a senior attorney in the Office of General Counsel, and as a Division Director in the Centers for Medicare & Medicaid Services.  In that latter position, he was responsible for, among other things, Stark policy, Provider Reimbursement Review Board procedures, and the Anti-Markup Rule.

Mr.  Romano is a frequent speaker and author on health law topics.  He is a past chair of the  American Bar Association Health Law Section’s Interest Group on Fraud and Compliance, and  a past vice-chair of the American Health Lawyers Association’s Regulations, Accreditation and Payment Group.  He earned his J.D. from the University of Baltimore in 1984 and his B.A. from Towson University.  He is admitted to the bars of the District of Columbia, Maryland and Massachusetts.

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.

Jodi Daniel is a partner in Crowell & Moring's Health Care Group and a member of the group’s Steering Committee. She is also a director at C&M International (CMI), an international policy and regulatory affairs consulting firm affiliated with Crowell & Moring. She leads the firm's Digital Health Practice and provides strategic, legal, and policy advice to all types of health care and technology clients navigating the dynamic regulatory environment related to technology in the health care sector to help them achieve their business goals. Jodi is a contributor to the Uniform Law Commission Telehealth Committee, which drafts and proposes uniform state laws related to telehealth services, including the definition of telehealth, formation of the doctor-patient relationship via telehealth, creation of a registry for out-of-state physicians, insurance coverage and payment parity, and administrative barriers to entity formation.

Prior to joining Crowell & Moring, Jodi was the founding director of the Office of Policy in the Office of the National Coordinator for Health Information Technology (ONC), U.S. Department of Health and Human Services (HHS) for a decade after serving in the Office of the General Counsel (OGC) at HHS for five years. At HHS, Jodi helped spearhead important changes in health information privacy and health information technology to improve health care for consumers nationwide. She was also one of the key drafters of the original Health Insurance Portability and Accountability Act (HIPAA) Privacy Rules and Enforcement Rules and developed the Nationwide Privacy and Security Framework for Electronic Exchange of Health Information.

As former director at ONC, she led the agency’s prominent federal advisory committees to build consensus on health IT standards and policy and established national health IT policy in areas including privacy, security, consumer e-health, health IT safety and oversight, and connecting health care payment and health IT. Jodi established ONC’s regulatory capacity and led the development of health IT standards and certification regulations. She worked across many federal agencies to develop the Federal Health IT Strategic Plan and coordinate policy, including with the Centers for Medicare and Medicaid Services (CMS) on the “meaningful use” of electronic health records, with Food and Drug Administration (FDA) on the safety of health IT, with the Drug Enforcement Agency (DEA) on legalizing electronic prescribing of controlled substances, with the Federal Trade Commission (FTC) on competition and health IT, with the Substance Abuse Mental Health Services Administration (SAMHSA) on integrating behavioral health and physical health, and with the White House Office of National Drug Control Policy (ONDCP) regarding opioid abuse. She also developed the Health Information Security and Privacy Collaboration, working with 42 state and territorial governments to address variation in privacy laws and challenges presented by electronic health information exchange through multi-state collaboration. Jodi formed the State Alliance for e-Health in collaboration with the National Governors’ Association, to promote e-Health, including electronic prescribing and multi-state licensure for telemedicine. She also represented the U.S. Government in presentations and engagements with foreign governments.

As the first senior counsel for health information technology at HHS, Jodi developed the foundational legal strategies and coordinated all legal advice regarding health IT for HHS, founded and chaired the health information technology practice group within OGC, and worked closely with CMS in the development of the e-prescribing regulations and the Stark and anti-kickback rules regarding e-prescribing and electronic health records.

Jodi began her career at a large insurance company advising employers on managed care and group health benefits.

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.

Larry Freedman is a Member of Mintz Levin, where his health care and life sciences litigation practice focuses on defending clients against allegations and investigations of fraud and abuse under the False Claims Act, the Anti-Kickback Statute, the Stark Law, the Civil Monetary Penalties Law, and other criminal, civil and administrative statutes.  His practice involves representing providers and plans under the Medicare, Medicaid, Medicare Advantage, Part D, and Medicaid managed care programs.

Prior to entering private practice in 2005, Larry served as an Assistant Director of the Civil Fraud Section of the U.S. Department of Justice(1997-2004).  He is the only former Assistant Director of the section now practicing as a defense lawyer. As an Assistant Director, he supervised hundreds of health care qui tam cases against hospital systems, laboratories, dialysis companies, nursing homes, and other providers, which were filed in U.S. district courts throughout the country.  He served as a Trial Attorney in the Civil Fraud Section (1991-1997) and co-led the Department’s Operation Labscam and other initiatives, for which he received the Attorney General’s highest and second highest awards.  Larry is a graduate of Colgate University and Yale Law School, and clerked for the Honorable Richard C. Cardamone of the U.S. Court of Appeals for the Second Circuit.

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.

Laura Weidenfeld is a partner in the Health Care and Life Sciences practice at Jones Day in Washington D.C.  Drawing on her extensive experience defending clients against health care fraud enforcement actions, Laura 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.  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. 

Laura regularly speaks and writes on health care fraud and abuse issues and has been an active member of the American Health Law Association (Chair, Fraud and Abuse Practice Group, 2014-2017) for over 15 years. She is the author of Legal Issues in Health Care Fraud and Abuse, Fifth Edition, published by AHLA in 2020.  Laura received her JD from Georgetown University Law Center and her BA and BM from Northwestern University.

Professor Elberg teaches in the areas of Health Law, Health Care Fraud and Abuse, Evidence, and Data Analytics. His areas of interest include corporate crime and compliance, the role of various actors in the enforcement of health care fraud laws and regulations, and criminal justice policy. Professor Elberg also serves as a faculty advisor for Seton Hall’s Healthcare Compliance Certificate Programs around the world.

Prior to joining Seton Hall Law School, Professor Elberg served for 11 years as 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, Professor Elberg led one of the largest and most impactful health care units in the country, supervising a team of 15 AUSAs and directing 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 including opioids, as well as all health care-related actions brought by the Office under the False Claims Act. In addition, Professor Elberg supervised and directed investigations regarding Foreign Corrupt Practices Act violations, as well as fraud against certain other government agencies and programs. Professor Elberg launched the District of New Jersey’s Data Mining Working Group and spearheaded the Office’s efforts to utilize data analytics to identify, investigate, and prosecute health care fraud offenses.

In 2013, Professor 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 convictions of nine individuals in six states, including three senior executives of one of the nation’s largest home healthcare companies. In 2016, Professor Elberg led the prosecution of Olympus Corp., resulting in a $646 million global criminal and civil resolution for violations of the Anti-Kickback Statute and the Foreign Corrupt Practices Act – the largest total amount paid in U.S. history for violations involving the Anti-Kickback Statute and the largest resolution of any kind involving a medical device company. In 2018, Professor 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.

Professor Elberg has been a leading speaker throughout the country on issues relating to health care fraud and abuse. He has been called upon to teach Department of Justice criminal and civil health care prosecutors from across the country on several occasions, including at the conference launching Deputy Attorney General Sally Yates’s Individual Accountability Initiative. Professor Elberg received his B.A., cum laude and with honors, from Dartmouth College and his J.D., magna cum laude, from Harvard Law School. After graduating law school, Professor Elberg clerked for the Honorable Nancy Gertner, United States District Court for the District of Massachusetts, and then practiced law as an associate at the firm of 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. He is a member of the Massachusetts, New Jersey, and New York Bars.

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.