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Hot Topics in Health Care Law 2020


Speaker(s): Adam Greenberg, Carol Vargo, Cheri Hale, David J. Farber, Kevin J. Malone, Kristine Blackwood, Laura F. Laemmle-Weidenfeld, Michael E. Paulhus, Rujul Desai, Shanya J. Dingle, T. Reed Stephens
Recorded on: Dec. 9, 2020
PLI Program #: 278467

Adam Greenberg is the General Counsel of Ro, a venture-backed, high-growth telehealth startup that operates the RomanRory, and Zero brands. Adam's responsible for all legal, regulatory, government affairs, and risk management functions across the company. Prior to Ro, Adam was Head of Legal and Public Policy at Warby Parker. Before moving in-house, Adam worked in the litigation, IP/tech, and real estate groups at Skadden Arps and spent a year clerking for a federal appellate judge on the Ninth Circuit Court of Appeals. Adam graduated from the University of Southern California School of Law and the University of Michigan. 


Kristine Blackwood has served as Counsel in the Legislative Practice and Public Policy Group at Arnold & Porter for the past five years. She represents a wide range of health care sector clients on Capitol Hill and with the Executive Branch, including medical societies and health professional associations; research institutes; children’s hospitals and health IT providers; and drug, diagnostic test and device manufacturers.

Ms. Blackwood brings multi-dimensional expertise and insider experience to advance her clients’ policy goals in Washington, drawing from over twenty years in leadership positions at the US Department of Health and Human Services (HHS), the US Department of Justice (DOJ), and House and Senate Committees with health care jurisdiction, as well as her private sector experience. During the Obama Administration, she served as Deputy Director for Congressional Oversight and Investigations at HHS, managing the Department’s strategic response to Congressional hearings and investigations in connection with the implementation of the Affordable Care Act and other Congressional inquiries involving high profile issues such as the Ebola epidemic; medical countermeasure procurements; compounding pharmacy regulation; drug discount programs; and mental health and substance abuse programs. Prior to serving at HHS, Ms. Blackwood was Chief Counsel for the Senate Special Committee on Aging, chaired by Senator Herb Kohl of Wisconsin, where she worked to advance Medicare and Medicaid program integrity measures included in the Affordable Care Act, and as Investigative Counsel for the House Committee on Energy and Commerce, chaired by former Representative John Dingell of Michigan, where she focused on health care policy and investigations. Ms. Blackwood also spent over twelve years as a career professional with the DOJ, serving as an Attorney-Advisor in DOJ’s Office of Legislative Affairs and as the National Healthcare Fraud Coordinator for the country’s 94 US Attorneys’ Offices. Before moving to Washington, DC, she served as an Assistant US Attorney for the Central District of California investigating and prosecuting complex health care fraud cases, where she led a multi-stakeholder coalition on nursing home fraud and abuse. Ms. Blackwood received her Bachelor of Arts degree from Boston University, and her JD from UCLA School of Law.

 


KEVIN J. MALONE is a Senior Counsel in the Health Care and Life Sciences practice in the Washington, DC, office of Epstein Becker Green and a Strategic Advisor in the firm’s affiliated consulting practice EBG Advisors. Mr. Malone provides regulatory and strategic guidance related to health care financing law and policy at both the federal and state levels, with a particular focus on Medicaid, Medicare, behavioral health, long-term care, and managed care.

Serving as strategic advisor and outside counsel to multiple national behavioral health medical specialty societies on the development and deployment of behavioral health clinical guidelines, intellectual property, and transactional matters

Serving as strategic advisor and outside counsel to a quasi-public Medicaid pre-paid inpatient health plan (PIHP) providing managed care business strategy, government relations, and legal representation covering transactional and compliance matters in an ongoing redesign of the state’s Medicaid delivery system

Prior to joining Epstein Becker Green, Mr. Malone served as a Health Insurance Specialist with the duals office within the Centers for Medicare and Medicaid Services (CMS), where he was the federal lead for implementing demonstration programs that aim to integrate the financing and delivery of Medicaid and Medicare benefits for dually-eligible beneficiaries in Illinois, New York State, and Washington State. Mr. Malone was a lead in the development of a new federal demonstration model for individuals with disabilities, based on the PACE model, expanding the model of care to new populations. Previously, Mr. Malone worked with the Disabled and Elderly Health Programs Group at CMS, developing a new policy for the identification and counseling of the medically frail within the Medicaid Expansion population.

As a Public Health Analyst with the Substance Abuse and Mental Health Services Administration (SAMHSA) prior to joining CMS, Mr. Malone managed multiple multimillion-dollar federal procurements and led the agency’s efforts to help substance abuse and mental health treatment providers implement advanced contracting, billing, and care coordination practices. In addition, he spearheaded SAMHSA’s efforts at public and private insurance enrollment following the enactment of the Affordable Care Act.

Before joining HHS, Mr. Malone served as a Peace Corps volunteer in Zambia, where he founded the nation’s first male-focused domestic violence prevention project.

Education

    The George Washington University Law School (J.D.)

    Washington University in St. Louis (B.A.)

Bar Admissions

    District of Columbia

    Massachusetts

    New York


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. 


Cheri Hale joined Catholic Health Initiatives in 1994 and is responsible for the planning, design and implementation of a system-wide compliance program for CommonSpirit Health Physician Enterprise, which includes more than 6,000 providers, 14 Clinically Integrated Networks, and three Management Services Organizations across the country.

Cheri began her career as an auditor with Ernst and Young and has many years of healthcare finance experience, particularly focused on physician practice operations.  She has served in various capacities for healthcare organizations such as Financial Analyst, Controller, and Chief Financial Officer prior to joining the CommonSpirit Corporate Responsibility team.

Cheri has published an article on the topic of physician practice data analytics and is a frequent speaker on compliance issues related to physician practice operations.  


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.


Mike Paulhus, a healthcare litigation partner, specializes in defending providers in government investigations, False Claims Act litigation, and crisis management. He also brings to bear his fraud and abuse defense expertise in proactive compliance assessments, regulatory counseling, and the submission of self-disclosures to regulators. A regular author and presenter, Mike also serves as an adjunct faculty member, teaching a Healthcare Fraud & Abuse seminar at Georgia State University School of Law.

Chambers USA has recognized Mike from 2017 to 2020, describing him as “a go-to attorney for providers facing external investigations and enforcement actions, as well as False Claims Act suits.”  In 2019, Mike took to trial and won a significant healthcare fraud case against the California Department of Insurance (CDI) and a relator in a major Insurance Frauds Prevention Act trial in Los Angeles County Superior Court, which was recognized as one of the Daily Journal’s 2019 Top California Verdicts.

Mike represents a wide range of clients across the healthcare delivery spectrum.  His clients have included academic medical centers, national and regional hospital systems, schools of medicine, pharmaceutical, medical device and biologics manufacturers, physician group practices, retail and long-term-care pharmacies, laboratory companies, skilled nursing facility operators, behavioral health facilities, home health, hospice and palliative care providers, and durable medical equipment suppliers.

Mike is actively involved in the community, serving as Secretary to the Board of Directors of The Atlanta Opera and Chairman of the American Health Law Association Fundamentals of Health Law Conference.

He served as a law clerk to the Honorable Kenneth F. Ripple, U.S. Court of Appeals for the Seventh Circuit.

EDUCATION

J.D., Washington and Lee University, summa cum laude, Order of the Coif

B.A., Boston College, summa cum laude, Phi Beta Kappa

CLERKSHIPS

Law Clerk, Honorable Kenneth F. Ripple, U.S. Court of Appeals for the Seventh Circuit

 


Rujul Desai is Of Counsel in Covington & Burling's regulatory health care practice group, based in Washington D.C.   He advises clients across a wide range of global market access issues, including strategies for new product launches, pricing and reimbursement, payer formulary access, value-based contracting, distribution network design, patient access and affordability programs, e-prescribing, digital health, and the use of health economic data and modeling for the promotion of drugs, devices, and diagnostic products.


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.


T. Reed Stephens has a wide array of experience in the life sciences industry, and represents pharmaceutical and biotech manufacturers, wholesalers and individuals, health care systems, and non-health care related companies in other global industries, including the financial services and banking sectors. He is a nationally recognized authority in the pharmaceutical fraud and abuse and corporate compliance spaces, and has extensive experience in Anti-Kickback Statute and Stark Physician Self-Referral Law False Claims Act litigation.

Reed has experience in matters involving state and federal government law enforcement and investigations. He represents hospital systems and managed care companies, and counsels pharmaceutical companies on government drug pricing and voluntary disclosures in the areas of Medicaid Drug Rebate, Federal Supply Schedule/Department of Veteran Affairs, and the 340B program.

Furthermore, Reed advises his clients on risk management concerns involving mergers and acquisitions, public policy, intellectual property protection, and an array of regulatory compliance matters concerning product marketing, foreign bribery prohibitions, and import/export controls.

Previously, Reed was a trial attorney with the U.S. Department of Justice Civil Division, where he led more than 60 investigations, the majority involving allegations of health care fraud perpetrated against various government agencies. Reed was lead counsel for the U.S. in the first successful cases against the pharmaceutical industry, involving Average Wholesale Price (AWP) reporting (US ex rel. Ven-A-Care v. et al.); Medicaid Drug Rebate price reporting (US ex rel. Foster v. Parke-Davis, US ex rel. Alcorn v. Schering-Plough); and Prescription Drug Marketing Act fraud (US ex rel. Gerstein v. TAP Pharmaceuticals).