False Claims Act/Qui Tam Whistleblower Litigation Involving Health Care Providers

Transcription

1 1 False Claims Act/Qui Tam Whistleblower Litigation Involving Health Care Providers Friday, May 6, 2016 presented by The South Carolina Bar Continuing Legal Education Division SC Supreme Court Commission on CLE Course No

2 2 Table of Contents False Claims Act Case Updates: Pharmacies & Pharmaceuticals Scott Schools False Claims Act Pleadings & Related Issues Marc S. Raspanti Private Causes of Action Accompanying FCA Qui Tam Cases Pamela C. Brecht Health Care FCA Qui Tam Cases: Hot Topics from the Plaintiff s Perspective Joseph P. Griffith, Jr. Pamela C. Brecht James C. Leventis, Jr. Hon. William N. Nettles Marc S. Raspanti Elizabeth C. Warren Stark Law Update Dan Mulholland False Claims Act Case Updates: Ambulance Companies J. Brady Hair Managing a Health Care Provider s Response to an FCA Investigation Daniel J. Westbrook False Claims Act Case Updates: Hospices Courtney E. Walsh False Claims Act Case Updates: Hospitals Mark Moore False Claims Act Case Updates: Laboratories Michael Gardener Whistleblower Retaliation Claims under Section 3730(h) of the False Claims Act Joseph P. Griffith, Jr. False Claims Act Cases: A District Judge s Perspective Hon. Joseph F. Anderson, Jr. Parallel Proceedings in False Claims Act Cases Deborah B. Barbier Beth B. Richardson Health Care FCA Qui Tam Cases: Hot Topics from the Defense Perspective Matthew R. Hubbell Deborah B. Barbier Mark T. Calloway E. Bart Daniel Joseph P. Griffith, Jr. J. Brady Hair Dan Mulholland Daniel J. Westbrook

3 3 False Claims Act/Qui Tam Whistleblower Litigation Involving Health Care Providers AGENDA 8:30 a.m. Registration 8:55 a.m. Welcome & Introductions Joseph P. Griffith, Jr. Joe Griffith Law Firm, LLC Matthew R. Hubbell, Hubbell Law Firm, LLC 9 a.m. False Claims Act Case Updates: Pharmacies & Pharmaceuticals Scott Schools Moore & Van Allen, PLLC 9:15 a.m. False Claims Act Pleadings & Related Issues Marc S. Raspanti Pietragallo Gordon Alfano Bosick & Raspanti, LLP 9:45 a.m. Private Causes of Action Accompanying FCA Qui Tam Cases Pamela C. Brecht Pietragallo Gordon Alfano Bosick & Raspanti, LLP 10:15 a.m. Mid-Morning Break 10:30 a.m. Health Care FCA Qui Tam Cases: Hot Topics from the Plaintiff s Perspective Joseph P. Griffith, Jr., Moderator Panel Discussion Pamela C. Brecht Pietragallo Gordon Alfano Bosick & Raspanti, LLP James C. Leventis, Jr. U.S. Attorney s Office Hon. William N. Nettles U.S. Attorney s Office Marc S. Raspanti Pietragallo Gordon Alfano Bosick & Raspanti, LLP Elizabeth C. Warren U.S. Attorney s Office 11:15 a.m. Stark Law Update Dan Mulholland Horty Springer & Mattern, PC 11:45 a.m. False Claims Act Case Updates: Ambulance Companies J. Brady Hair Law Office of J. Brady Hair 12 p.m. Lunch (provided by Health Care Law Section)

4 4 1 p.m. Managing a Health Care Provider s Response to an FCA Investigation Daniel J. Westbrook Nelson Mullins 1:30 p.m. False Claims Act Case Updates: Hospices Courtney E. Walsh Parker Poe Adams & Bernstein, LLP 1:45 p.m. False Claims Act Case Updates: Hospitals Mark Moore Nexen Pruet 2 p.m. False Claims Act Case Updates: Laboratories Michael Gardener Mintz Levin Cohn Ferris Glovsky & Popeo, PC 2:30 p.m. Whistleblower Retaliation Claims under Section 3730(h) of the False Claims Act Joseph P. Griffith, Jr. Joe Griffith Law Firm, LLC 2:45 p.m. Afternoon Break 3 p.m. False Claims Act Cases: A District Judge s Perspective Hon. Joseph F. Anderson, Jr. U.S. District Judge 3:30 p.m. Parallel Proceedings in False Claims Act Cases Deborah B. Barbier Deborah B. Barbier, LLC Beth B. Richardson Sowell Gray Stepp & Laffitte, LLC 3: 45 p.m. Health Care FCA Qui Tam Cases: Hot Topics from the Defense Perspective Matthew R. Hubbell, Moderator Panel Discussion Deborah B. Barbier Deborah B. Barbier, LLC Mark T. Calloway Alston & Bird LLP E. Bart Daniel E. Bart Daniel, Attorney at Law Joseph P. Griffith, Jr. Joe Griffith Law Firm, LLC J. Brady Hair Law Office of J. Brady Hair Dan Mulholland Horty Springer & Mattern, PC Daniel J. Westbrook Nelson Mullins 4:30 p.m. Adjourn

5 5 Speaker Biographies Joseph P. Griffith Jr. Joseph P. Griffith, Jr. s legal practice focuses on white collar criminal defense and Qui Tam/False Claims Act litigation. Based in Charleston, South Carolina, his white collar defense practice focuses on health care fraud, securities fraud, antitrust crimes, bank fraud, bankruptcy fraud, campaign finance crimes, commercial bribery, computer fraud, criminal tax fraud, customs crimes, defense procurement fraud, environmental crimes, gambling, insurance fraud, and public corruption crimes. He has extensive experience in federal grand jury investigations and corporate internal investigations, and has tried nearly 30 federal court cases. He was an Assistant United States Attorney in the South Carolina district for almost 13 years, prosecuting numerous white collar crimes. Past and present clients include a number of publicly traded and private corporations, and/or their CEOs, COOs and CFOs, who have been subjected to a variety of white collar investigations, litigation and/or prosecutions. He also has extensive experience in federal False Claims Act/Qui Tam litigation, and has represented and/or counseled hospitals, hospital executives, physician practices, physicians, dentists, laboratory marketers, cosmetology schools, therapy providers, military contractors and government construction contractors in False Claims Act cases. Griffith is the co-author of two books published by the South Carolina Bar Association: Health Care Fraud and Collateral Consequences (2011) and Federal and State Securities Enforcement (2008). He is a former United States Department of Justice (DOJ) National Advocacy Center Instructor in both Criminal Trial Advocacy and Civil Trial Advocacy. He has taught numerous Continuing Legal Education seminars on a variety of False Claims Act topics. He currently serves as Co-Chairman of the Qui Tam Section of the South Carolina Federal Bar Association. He is a graduate of University of North Carolina at Chapel Hill (B.A. 1979) and University of South Carolina School of Law (J.D. 1982). He is the founding member of Joe Griffith Law Firm, LLC, has received an AV rating from Martindale-Hubbell, an AVVO 10 Rating, is a member of the Bar Register of Pre-eminent Lawyers, the Multi-Million Dollar Advocates Forum, and has been selected as one of the Best Lawyers in America and as a South Carolina Super Lawyer. He has been admitted to practice in all South Carolina State Courts, United States District Courts of South Carolina, Georgia (pro hac vice) and Indiana (pro hac vice), the Fourth Circuit Court of Appeals, and the United States Supreme Court. He is a member of the Fourth Circuit Court of Appeals Judicial Conference. Matthew R. Hubbell With well over 20 years of litigation experience, Matthew R. Hubbell defends clients in white-collar criminal prosecutions, False Claims Act litigation, and enforcement proceedings. As an Assistant United States Attorney in South Carolina from 1991 to 2000, he prosecuted complex white collar cases. Since 2001, Hubbell has represented companies, corporate executives, and other individuals in federal and state white collar matters, including antitrust, health care, environmental, tax, bank fraud, and securities cases. He regularly represents clients in internal investigations, grand jury investigations, and trials. Hubbell is the President-Elect of the South Carolina Chapter of the Federal Bar Association and Co-Chair of its newly created Qui Tam Practice Group. He also serves on the Board of the FBA's national Qui Tam section, and as an officer of the Health Care Law Section of the South Carolina Bar.

6 6 Hubbell has an A V rating from Martindale-Hubbell and is a permanent member of the Fourth Circuit Judicial Conference. He has co-authored several books regarding white-collar criminal law, including Health Care Fraud and Collateral Consequences, 2d Edition (S.C. Bar 2011), Federal and State Securities Enforcement (S.C. Bar 2008), and Computer and Intellectual Property Crimes (S.C. Bar 2003). Hubbell has also served on the Executive Committee of the Charleston County Bar, and he recently served as Chair of the Merit Selection Panel for the United States Magistrate Judge in Charleston. Scott Schools Scott Schools spent 18 years with the Department of Justice before joining the Charleston office of Moore and Van Allen in August From 2008 to 2013, Schools served in Washington, DC, as an Associate Deputy Attorney General. In that capacity, he provided advice and counsel to the Deputy Attorney General of the United States on issues ranging from complex criminal investigations and policy matters to professional responsibility, ethics, employment, and civil rights matters. Prior to joining the Deputy Attorney General's office, Schools served as the United States Attorney in two judicial districts, the Northern District of California ( } and South Carolina (2001}. For two years ( ), Schools served in Washington as the General Counsel of the Executive Office for United States Attorneys (EOUSA), where he advised the United States Attorneys' Office throughout the country on employment and ethics issues. He served as the First Assistant U.S. Attorney in South Carolina from 2001 to While serving in various capacities in the United States Attorney's Office for the District of South Carolina, he tried approximately twenty-four federal criminal cases involving public corruption, health care fraud, bank fraud, mail and wire fraud, narcotics conspiracy, and homicide, including two capital cases. He now represents individuals and entities in matters involving white collar crime, government regulatory investigations, and health care issues. His practice includes white collar criminal defense, regulatory matters, and health care defense. Marc S. Raspanti Marc S. Raspanti is a name partner of Pietragallo Gordon Alfano Bosick & Raspanti, LLP. He founded the firm s national affirmative Qui Tam practice group and has been recognized as one of the most successful, skilled and experienced qui tam attorneys in the United States. Mr. Raspanti focuses his national litigation practice on affirmative federal and state qui tam litigation, health care litigation, complex commercial litigation, and white collar criminal defense. He started his career as a prosecutor in Philadelphia and spent time at three well-respected Philadelphia litigation firms before forming his own law firms. He is a 1979 graduate of Villanova University and 1984 Temple Law School graduate. In March 1999, Philadelphia Magazine named Mr. Raspanti one of the best white collar criminal defense lawyers in Philadelphia. Following that honor, Mr. Raspanti was selected by his peers as one of Pennsylvania's Super Lawyers from 2004 through 2015 in the field of White Collar Criminal Defense, an honor reserved for 5% of the Pennsylvania Bar. In addition, from 2007 through 2015, he was listed as one of the Top 100 Pennsylvania Super Lawyers. From 2008 through 2015, he was selected as one of the Top 100 Philadelphia Super Lawyers. He was selected by his peers for the 2006 through 2015 editions of Best Lawyers in America in the area of Health Care Law litigation and was included in the 2015 edition of Best Attorneys in Pennsylvania. In 2012, Mr. Raspanti was elected as a Fellow of the American College of Trial Lawyers, an organization devoted to recognizing outstanding civil and criminal trial lawyers in the United States and Canada. Mr. Raspanti has been recognized as a national leader in his field by such organizations as Law Dragon 500 magazine and the US Healthcare Expert Guide. LexisNexis Martindale-

7 7 Hubbell also recognizes Mr. Raspanti as an AV Preeminent rated attorney, the highest such rating available to any individual lawyer in both legal ability and ethical standards. Since 1989, Mr. Raspanti has litigated or is currently litigating some of the most complex and important cases in the history of the federal False Claims Act. He has served as lead counsel for whistleblowers in false claims cases that have resulted in over $2 billion in recoveries for federal and state taxpayers. Mr. Raspanti frequently speaks, writes, lectures and comments on litigation strategy, qui tam and health care fraud issues. He has served as an Adjunct Professor of Law teaching health care fraud classes at Hamline University School of Law in Minnesota, and frequently lectures at other law schools throughout the United States. Mr. Raspanti is a member of the Federal, American, Pennsylvania and Philadelphia Bar Associations. He is a member of the Committee on Criminal Law of the Federal Bar Association, the Committee on Complex Crimes Litigation, the Sub-Committee on White Collar Crime of the American Bar Association. Mr. Raspanti is also a member of the American Health Lawyers Association and the National Association of Criminal Defense Lawyers and has been recognized for his exemplary service as Vice Chair of the White Collar Crime Committee. He is a member of the Health Care Compliance Association, an organization dedicated to ethical practices in the field of health care compliance. Mr. Raspanti is admitted to practice in courts in Pennsylvania and New York. Mr. Raspanti was co-lead counsel for whistleblowers in a number of the most successful false claims cases litigated in United States history and has also written a number of authoritative articles on federal and state false claims statutes. Pamela C. Brecht Pamela Coyle Brecht is a partner at Pietragallo Gordon Alfano Bosick & Raspanti, LLP. Ms. Brecht is based in the firm s Philadelphia office and is an active member of the Qui Tam Practice Group. She also has experience in employment law, white collar criminal litigation, and labor relations. She has been or is currently involved in litigating some of the most complex Qui Tam cases filed in the United States. Her cases have included alleged fraud by a large multi-state Medicaid managed care contractor, FCA violations by three of the largest hospital corporations in the country, and complex financial relationships among healthcare providers, as well as pharmaceutical fraud. She is also part of the team that is advancing one of the first national cases alleging fraud against the Medicare Part D program. Ms. Brecht is a 1988 graduate of Villanova University and a 1991 graduate of Temple University School of Law. While attending Temple University School of Law, Ms. Brecht served as a member of the Temple Law Review, was on the Dean s List, and received honors for Distinguished Class Performance. Ms. Brecht is a member of the Philadelphia Bar Association, the American Health Lawyers Association, the Health Care Compliance Association, the Federal Bar Association Qui Tam Section, and the Brehon and Justinian Law Societies. Ms. Brecht frequently speaks, writes, and lectures on qui tam litigation and health care fraud issues. Some of her representative articles include: The Tar Heel State Steps Up Its Fight Against Fraud; The

8 8 Tar Heel State Steps Up Its Fight Against Fraud - Part II; The Minnesota False Claims Act: Is It Minnesota Nice?; The Employment Protection and Anti-Discrimination Provisions of the New Jersey State False Claims Act; The 'New' New Jersey False Claims Act: It Was Born to Run. Ms. Brecht was co-lead counsel for whistleblowers in a number of the most successful false claims cases litigated in United States history. Ms. Brecht is admitted to practice in all courts in Pennsylvania. Ms. Brecht has also written a number of authoritative articles on federal and state false claims statutes. Ms. Brecht frequently speaks, lectures and comments on litigation strategy, qui tam and health care fraud issues. James C. Leventis Jr. James is an Assistant U.S. Attorney and is primarily responsible for handling federal civil prosecution of health care and procurement fraud cases throughout South Carolina. James joined the U.S. Attorney s office as a criminal prosecutor and handled narcotics and violent crime cases. Prior to joining the U.S. Attorney s Office, James was an associate in private litigation practices in Columbia, South Carolina and Palo Alto, California. James is a graduate of the Santa Clara University School of Law and received his undergraduate degree from the University of Virginia. The Honorable William N. Nettles Bill Nettles was sworn in as the United States Attorney for the District of South Carolina on May 3, Immediately prior to becoming the U.S. Attorney, Mr. Nettles was a member of Sanders & Nettles, LLC in Columbia, South Carolina where he practiced since Mr. Nettles was a sole practitioner from November 1997 to October From September 1995 to May 1997, he was a member of Banks & Nettles, LLC in Camden, South Carolina. Mr. Nettles worked as an Assistant Public Defender in Columbia, South Carolina from August 1992 through September While in private practice, Mr. Nettles concentrated his practice in criminal defense, including the defense of white-collar crime, street crimes, as well as several court-appointed capital cases. He has also handled medical malpractice and other civil tort litigation. He has tried over fifty cases in state and federal court, the majority of which were criminal. Mr. Nettles is a member of the American Bar Association, th e South Carolina Bar, and the Pennsylvania Bar (inactive). He has been admitted to practice before the United States Supreme Court (11/27/00), the United States Court of Appeals for the Fourth Judicial Circuit (2/24/98), the United States District Court for the District of South Carolina (5/1/96), and the South Carolina Supreme Court (11/18/92). Since becoming a member of the Bar, he has received the President s Award from the National Association of Criminal Defense Lawyers, the President s Award from the South Carolina Criminal Defense Lawyers, the NAACP Foot Soldier in the Sand Award, and the NAACP Outstanding Legal Service Award. Mr. Nettles graduated from Widener University School of Law in 1995, where he was President of the Student Bar Association, on the Widener University Law Review, and a member of the Widener University Moot Court Honor Society. Mr. Nettles attended the Citadel for his undergraduate degree. Since graduation, he has published and lectured extensively.

9 9 Elizabeth C. Warren Beth is an Assistant U.S. Attorney and is primarily responsible for handling federal civil prosecution of health care and procurement fraud cases locally and nationally. In 2012, Beth joined the Affirmative Civil Enforcement unit of the U.S. Attorney s office in Columbia, South Carolina. Prior to joining the U.S. Attorney s Office, Beth clerked for the Honorable Chief Justice Jean H. Toal. In her former career, Beth worked in the healthcare industry as a pharmaceutical sales representative for Pfizer, Inc. Beth is a cum laude graduate of University of South Carolina School of Law where she was a member of the Order of Wig and Robe, served on the editorial board of the South Carolina Law Review, and as Chairperson of the Honor Council. Beth received her undergraduate degree from the Terry School of Business at the University of Georgia in Dan Mulholland Dan Mulholland received his Bachelor s and Master s degrees from Duquesne University and his law degree from the University of Pittsburgh. He is a senior partner in the law firm of Horty, Springer & Mattern, P.C., in Pittsburgh. Mr. Mulholland is an editor of a number of HortySpringer publications, including the Health Law Express, a free weekly on health law developments, and a speaker at HortySpringer seminars and audio conferences. Named in 1997 by the National Law Journal as one of 40 health care attorneys who have made their mark and listed in The Best Lawyers in America and Pennsylvania Super Lawyers. Mr. Mulholland has spoken and written extensively concerning a wide variety of health law topics. He regularly advises clients on hospital medical staff, corporate, tax, fraud and abuse and compliance matters, and prepares and negotiates all manner of contracts between hospitals, physicians and managed care organizations. He also serves as trial and appellate counsel in False Claims Act, qui tam, antitrust, tax exemption, contract and peer review litigation. Mr. Mulholland serves as a faculty member of the Estes Park Institute and is a former Chair of the Credentialing and Peer Review Practice Group of the American Health Lawyers Association. He frequently provides strategic counseling to hospital and health system boards, as well as transactional services regarding mergers, acquisitions, joint ventures and affiliations. J. Brady Hair Brady Hair practices in North Charleston, South Carolina. The practice is focused on "White Collar" Federal Criminal work and complex Civil Litigation including False Claims Act (FCA) defense. The practice also handles appellate work and the firm has handled many cases before the South Carolina Supreme Court, Court of Appeals and the Fourth Circuit. Mr. Hair served as an Assistant United Sates Attorney where he prosecuted all types of Fraud cases and other Federal matters. He has been General Counsel to the City ofnorth Charleston for 21 years. Mr. Hair has represented clients in various fraud investigations over the past 20 years. He has represented Health Care providers ranging from individual physicians and administrators to hospitals and Nationwide Health Care providers. He defended the first Federal Health Care case to go to trial in South Carolina. He has handled Health Care cases involving Hospice, Nursing Homes, Ambulance Services, Dialysis Clinics as well as many Hospitals and various specialty and general physicians. Mr. Hair has served as President of the Charleston County Bar Association. He also served as President of the South Carolina Association of Municipal Attorneys. He coauthored Health Care Fraud and Collateral Consequences (2000) and the Second Edition (2011) He also served on the editorial board of Environmental Crimes and Corporate Liability (1999).

10 10 Daniel J. Westbrook Dan Westbrook received his Juris Doctor from the University Of South Carolina School Of Law, his MFA from the University of North Carolina and his BFA from Valdosta State College. Dan is a partner in the Columbia office of Nelson Mullins, where he practices in the areas of healthcare law and business litigation. Dan is admitted to practice in South Carolina, North Carolina, the Supreme Court of U.S., the U.S. Court of Appeals for the Fourth Circuit, and the U.S. District Court for the District of South Carolina. Dan s experience includes: Federal and state court litigation and appeals, representing a wide variety of healthcare and nonhealthcare-related clients, involving such allegations as violation of the False Claims Act, breach of contract, ERISA, unfair trade practices, conspiracy, malpractice, and equitable indemnification Numerous CON matters before DHEC and the South Carolina Administrative Law Court representing hospitals, physician groups, nursing homes, home health agencies, radiation therapy centers, hospices, and behavioral health facilities Medicare and Medicaid appeals and compliance Professional licensing administrative actions Peer review actions representing both hospitals and physicians Pro bono matters include several death penalty and other criminal appeals, parole hearings, and a class action on behalf of over 2,500 mentally ill inmates seeking better prison conditions Previously Dan was a former Adjunct Professor in healthcare law, University of South Carolina School of Law, Assistant Professor of Theatre, Case Western Reserve University ( ) and a Professional Actor, Great Lakes Shakespeare Festival, Cleveland Play House, and Playmakers Repertory Company. Dan is a member of the American Health Lawyers Association, the American Bar Association and the Richland County Bar. He is Former Chairman, South Carolina Bar's Health Law Committee and was a Board Member ( ) and Board Chair ( ) for the South Carolina Death Penalty Resource & Defense Center. Dan s awards include: The Best Lawyers in America -- Health Care Law ( ), The Best Lawyers in America 2012 Lawyer of the Year, Columbia, S.C., Health Care Law and, South Carolina Super Lawyers ( ). Courtney E. Walsh Court Walsh received his B.A. in 2001 from The Citadel, his J.D. from the University of Florida in 2004 and his LL.M from Harvard Law School in Court Walsh generally concentrates on handling and litigating cases involving construction projects, government contracts, environmental disputes, and False Claims Act quit tam actions. Before joining Parker Poe, Mr. Walsh spent more than nine years in government service as an officer and attorney in the U.S. Marine Corps. In his last assignment in government service, Mr. Walsh served as an environmental and government contract law counsel. During his military service, Mr. Walsh also served as a Special Assistant U.S. Attorney in the Eastern District of North Carolina. Mark Moore Mark C. Moore graduated from the University of South Carolina with his J.D. in 1987 and from Wofford College with a B.A. (History), cum laude in He is admitted to practice in the U. S. Court of Appeals for the Fourth Circuit and the U. S. District Court for the District of S.C. Mark s area of experience includes Corporate Compliance, Litigation, and White Collar Criminal Defense.

11 11 Mark was a prosecutor in South Carolina for more than twenty-five years, serving an Assistant Solicitor in Charleston before joining the United States Attorney s Office in Columbia in As a federal prosecutor, Mark handled thousands of cases, tried more than sixty cases to jury verdict and prosecuted cases in every federal courthouse in this state. During his time in the United States Attorney s Office, Mark focused his attention on complex cases. He started working in the Organized Crime and Drug Enforcement Task Force (OCDETF) unit and was selected to lead it As an OCDETF prosecutor, Mark utilized court-authorized wiretaps to prosecute thousands of drug dealers, gang members and money launderers. During this time, Mark developed the trial skills which eventually made him the go-to person in the office for complex trials. Mark has served in various management positions at the United States Attorney s Office that includes: Lead OCDETF AUSA as Narcotics Chief, and as the Deputy Criminal Chief, Coordinator for the Financial Crimes Task Force, and Public Corruption Coordinator. Also, Mark served two separate terms as Senior Litigation Counsel. In this role, he concentrated on the prosecution of complex white collar and organized crime cases. He also trained and mentored new federal prosecutors. Mark has substantial experience handling complex white collar matters, including cases involving: Mail fraud, Wire fraud, Health care fraud, Racketeering, Public corruption, Qui tam & False Claims Act cases (parallel civil and criminal proceedings). Mark also has significant experience handling both criminal and civil forfeiture cases. Mark has also worked on joint investigations with the South Carolina Attorney General s Office and was previously designated as a Special Assistant Attorney General for South Carolina. From 1997 until 2000, he served the Department of Justice (DOJ) as a Special Counsel with the Office of Inspector General. In Washington, New York, Chicago and Miami Mark worked on a special, Congressionallymandated, internal investigation into the then-immigration and Nationalization Service s (INS s) handling of the Citizenship USA program. He served as a Special Assistant United States Attorney in four different judicial districts (Eastern District North Carolina, Western District of North Carolina, Middle District of Georgia and Southern District of West Virginia). In that role, Mark handled cases and coordinating investigations at the request of the Executive Office for United States Attorneys (EOUSA). For more than 15 years, Mark served EOUSA as an instructor at the National Advocacy Center (NAC) and he served for more than ten years as an EARS evaluator and team leader. As an EARS evaluator, Mark worked with federal prosecutors in conducting peer evaluations for United States Attorney s Offices around the country. Mark is a Recipient of the National OCDETF award for Regional OCDETF Case of the Year (2009, 2012), a Recipient of the Southeastern OCDETF Regional Coordinators' Award (2004, 2007) and a Recipient of the EOUSA Director's Award for Superior Performance in a Management. Michael Gard ner Michael Gard ner received his BS from Cornell University and his JD from the University of Pennsylvania. He is admitted in Massachusetts, United States Court of Appeals for the First Circuit, United States District Court for the District of Massachusetts, and the United States Supreme Court. Michael specializes in complex civil and criminal litigation and class actions at Mintz Levin Cohn Ferris Glovsky & Popeo, PC, representing Fortune 100 corporations, health care companies, real estate developers and financial institutions in courts across the country. In addition to his full litigation practice, Michael also serves as General Counsel to the firm.

12 12 He Co-authored, 5 Tools for Defending Against Copycat Derivative Suits, Corporate Counsel in The Honorable Joseph F. Anderson Jr. Joseph F. Anderson, Jr. was appointed United States District Judge by President Ronald Reagan in October Prior to that, Judge Anderson practiced law in Edgefield, South Carolina, and represented Edgefield and Aiken Counties in the South Carolina General Assembly. He is a graduate of Clemson University and the University of South Carolina School of Law. When appointed at age 36, Judge Anderson became the youngest federal judge in South Carolina history and the second youngest in the country. He has served on the federal bench for 30 years, seven of those years as Chief Judge. A strong advocate of legal education, Judge Anderson has taken part in more than 200 CLE and lawrelated programs, committees and associations, including a six-year seat on the Federal Rules of Evidence Committee of the United States Judicial Conference. He also has authored two popular books on trial advocacy for lawyers. Judge Anderson recently took senior status, but retains an active court schedule, in addition to serving as an adjunct professor of Evidence and Federal Courts at the University of South Carolina School of Law. Deborah B. Barbier Deborah Barbier graduated cum laude from the University of South Carolina School of Journalism in In 1994, she graduated from the University of South Carolina School of Law. After law school, she served as a law clerk in state court to the Honorable Joseph A. Wilson, II, while he was the Chief Administrative Criminal Judge for the Fifth Judicial Circuit. She then served as a federal judicial law clerk for the Honorable Joseph F. Anderson, Jr. in the United States District Court. Ms. Barbier worked for fifteen years as an Assistant United States Attorney for the District of South Carolina. The first five years she was the lead attorney for the district's Affirmative Civil Enforcement division where she primarily prosecuted civil health care fraud, and procurement fraud. Ms. Barbier worked in the criminal division of the US Attorney's Office for 10 years, prosecuting criminal health care fraud, securities fraud, mortgage fraud, white collar fraud, public corruption, violent crimes and drug crimes. She served on numerous task forces designed to combat financial crimes, health care fraud, terrorism, and public corruption. She was the lead attorney for the Asset Forfeiture division for two and a half years. She was the Chief of the White Collar Division for more than five years. She is currently in private practice specializing in white collar criminal defense and False Claims Act litigation. She recently became a Fell ow in the American College of Trial Lawyers. Beth B. Richardson Beth Richardson is Of Counsel at Sowell Gray. Her practice focuses on business contract and tort, false claims, shareholder oppression, employment, and professional malpractice matters both in courtroom and arbitration settings, including FINRA. Drawing on her experience as an appellate clerk, Beth enjoys an active appellate practice in both state and federal court, and has handled appeals on a variety of issues, including novel issues of law, on cases originating inside and outside the firm. Prior to joining the firm, Beth taught Advanced Legal Writing at the University of South Carolina School of Law, and completed judicial clerkships in both the United States District Court for the District of South Carolina and the United States Court of Appeals for the Fourth Circuit. She received

13 13 her undergraduate degree from Duke University, and her law degree from Washington University School of Law in St. Louis, where she served as Editor in Chief of the Law Review. Beth currently serves as Treasurer for the SC Chapter of the Federal Bar Association and is a Member of the District Court Advisory Committee, US District Court for the District of South Carolina. She is also active in the committee where she holds various leadership positions. Mark T. Calloway Mark T. Calloway, immediate past leader of the firm s Investigations Government & Special Group, concentrates his practice on white collar criminal defense, with an emphasis on health care, internal corporate investigations, compliance program development, implementation and auditing. Prior to joining Alston & Bird, Mark served as the U.S. Attorney for the Western District of North Carolina from 1994 to During his tenure with the Department of Justice, Mark also served as director of the Executive Office for United States Attorneys, was responsible for support and oversight of all 93 U.S. Attorneys Offices, and played a key role in management and policy implementation for the Department of Justice. He also served as chair of the White Collar Crime Subcommittee of the Attorney General s Advisory Committee. In 2001, Attorney General Janet Reno awarded Mark the Edmund J. Randolph Award for outstanding service to the Department of Justice. Mark has been listed in The Best Lawyers in America since 2005 and has been recognized by Super Lawyers magazine on multiple occasions. His peers in the legal community have selected Mark as one of North Carolina s "Legal Elite." He is Past Chair of the Criminal Justice Section of the North Carolina Bar Association and was Advisor to the Ethics Committee of the North Carolina State Bar from, E. Bart Daniel Bart Daniel was nominated by President Bush to serve as United States Attorney for the District of South Carolina and confirmed by the United States Senate in He served until 1992 having been awarded numerous national honors for his service. Bart graduated from law school in 1980, and began serving as an Assistant State Attorney General assigned to its Economic Crime Unit. He prosecuted financial crimes, tax fraud and other white collar cases in State Court for two years. For the next four years, Bart served as an Assistant United States Attorney prosecuting fraud, securities, tax, and customs violations. In 1985, Bart entered private practice where he concentrated on white collar criminal defense and selected civil litigation. In March 1991, Bart was presented the United States Attorney's Flag Award, the highest award given to any United States Attorney, for his outstanding achievements in the prosecution of Operation Lost Trust, the largest legislative public corruption case in our nation's history. Bart returned to private practice in Since that time, he has been active in white collar, health care, environmental, securities and business litigation. He has successfully defended numerous white collar prosecutions including health care fraud, environmental crimes, customs, and securities violations. Bart has obtained numerous not guilty verdicts in federal and state white collar criminal trials.

14 14 Bart Daniel Attorney at Law Bart prosecuted the state's first criminal environmental case and has been active in the prosecution and defense of such cases on both the federal and state levels. He has spoken before the American Bar Association, as well as at numerous conferences and seminars on white collar, health care, securities and environmental crimes. Bart has served as Special Counsel to the Governor, conducting an internal investigation into allegations of public corruption and influence peddling in state government. He also served as Lead Counsel for the South Carolina House of Representatives before a Three-Judge Federal Panel in the trial involving reapportionment and the drawing of district lines. Bart also was appointed Special Counsel by the South Carolina Secretary of State to handle a complex security fraud matter with national implications. Bart has both prosecuted and defended False Claim Act or "whistleblower" actions in the U.S. District Court. Bart has been selected each year for South Carolina Super Lawyers and is an AV Peer Review Rated lawyer by Martindale Hubbell. Bart currently serves a three year term on the Board of the National Association of Former United States Attorneys.

15 15 False Claims Act/Qui Tam Whistleblower Litigation Involving Health Care Providers Friday, May 6, 2016 False Claims Act Case Updates: Pharmacies & Pharmaceuticals Scott Schools

16 Pharmacies and Pharmaceutical Companies Scott Schools Moore & Van Allen, PLLC May 6,

17 Retailer issues Rewards and incentives Billing Manufacturer issues Kickbacks Prior authorization requests Misbranding Discounts 17

18 Rewards and incentives What they can do: OIG Advisory Opinion Asked whether grocery store chain that gives gasoline discounts based on purchase volumes could be subject to CMP or AKS violation if the volume includes co-pays on prescriptions OIG said no to both questions 18

19 CMP answer based on ACA exception for rewards Three pronged exception The rewards consist of coupons, rebates, or other rewards from a retailer; The rewards are offered or transferred on equal terms available to the general public, regardless of health insurance status; and The offer or transfer of the rewards is not tied to the provision of other items or services reimbursed in whole or in part by the Medicare or Medicaid programs. 19

20 The grocer qualified as a retailer and the rewards came from the grocery store. Program was offered to all customers not just pharmacy customers The reward was gasoline (not any service reimbursed by a GHP) and the award calculation was based on all purchases not just prescription purchases. AKS likewise not violated: OIG noted no parallel exception for AKS. But noted that reward structure would pose a minimal risk of fraud and abuse. 20

21 Cannot offer discounts for moving prescription business Cannot offer discounts tied to prescriptions Kmart Case (settled 9/2015 for $1.4 million) Kmart permitted Medicare beneficiaries to use drug manufacturer coupons to reduce or eliminate prescription co-pays that they otherwise would be obligated to pay. Kmart encouraged Medicare beneficiaries to bring their prescriptions to Kmart pharmacies by offering them varying levels of discounts on the purchase of gasoline at participating gas stations based on the number of prescriptions that they filled at Kmart pharmacies. 21

22 Rite Aid (settled 11/2014 for $2.99 million) Rite Aid knowingly and improperly influenced the decisions of Medicare and Medicaid beneficiaries to transfer their prescriptions to Rite Aid pharmacies by offering them gift cards in exchange for their business. Walgreen (settled April 2012 for $7.9 million) The settlement resolves allegations that Walgreens offered illegal inducements to beneficiaries of government health care programs in the form of gift cards, gift checks and other similar promotions to transfer their prescriptions to Walgreens pharmacies. 22

23 Usual and customary pricing Manufacturer rebates United States of America ex rel. Kammerer, et al. v. Omnicare, Inc. (Settlement September 2010) 23

24 On October 29, 2015, DOJ announced W-C would plead guilty to criminal AKS violations and pay $125 million to resolve FCA liability Categories of misconduct Kickbacks Expensive dinners (capped at $125 per attendee), happy hours, speaking fees (roundtable dinners at which speaker would receive $500 to $1200), golf outings, wine, and other gifts. Personal services exception Falsification of prior authorization requests Purpose was to improve coverage of W-C s high end drugs under Part D 24

25 Misbranding Impact of United States v. Caronia, 703 F.3d 149, 168 (2d Cir. 2012). See United States v. Vascular Solutions, Inc. CRIMINAL NO. SA-14-CR-926-FB (W.D. Tex. 2015). Discount coupons, rebates, and loyalty cards to evade government program cost controls. 25

26 Case settled October 2015 for $9.25 million AKS violations Payments to consultant pharmacists to nursing homes to recommend Depakote Payments were in the form of: Rebates Educational grants Other financial support 26

27 Relevant is the personal services exception to AKS Elements: Agreement is in writing. Agreement covers all of the services specifies the services to be provided. If part-time, the agreement specifies the schedule of such intervals, their precise length, and the exact charge for such intervals. Agreement is for not less than one year. Aggregate compensation is set in advance, is consistent with fair market value in arms-length transactions and is not determined in a manner that takes into account the volume or value of any referrals. The services do not involve the counselling or promotion of a business arrangement that violates any State or Federal law. The aggregate services contracted for do not exceed those which are reasonably necessary to accomplish the commercially reasonable business purpose of the services. 27

28 28

29 29 False Claims Act/Qui Tam Whistleblower Litigation Involving Health Care Providers Friday, May 6, 2016 False Claims Act Pleadings & Related Issues Marc S. Raspanti

30 30 FALSE CLAIMS ACT/QUI TAM WHISTLEBLOWER LITIGATION INVOLVING HEALTH CARE PROVIDERS SOUTH CAROLINA FEDERAL BAR ASSOCIATION AND SOUTH CAROLINA BAR HEALTH CARE SECTION Friday, May 6, 2016 South Carolina Bar Conference Center 1501 Park Street, Columbia SC

31 31 RELATOR PLEADING ISSUES Friday, May 6, :15 a.m. 9:45 a.m. Marc Stephen Raspanti, Esquire PIETRAGALLO GORDON ALFANO BOSICK & RASPANTI, LLP 1818 Market Street, Suite 3402 Philadelphia, PA (215)

32 32 RELATOR PLEADING ISSUES Framing the claims for the court and others Claim by Claim Analysis (Rockwell Int l Corp. v. United States, 549 U.S. 457 (2007)) Adding State FCA and Federal FCA Causes of Action in the same complaint; different complaints Anti-kickback statutes What other federal and state laws or regulations were violated?

33 IRS & SEC Bounty Programs Pendent Jurisdiction Issues (28 U.S.C. 1367) 26 U.S.C (IRS) 15 U.S.C. 78u-6 (b) (SEC) NY FCA Tax Provisions N.Y. State Fin. 189 State of N.Y. ex rel. Danon v. Vanguard Group, Inc. (N.Y. Supreme Court, November 13, 2015) 33

34 34 BASIC PLEADING CONCERNS Pre-Filing Disclosures for Federal and State 31 U.S.C (b)(2) Best Practice Tip Often Forgotten or Poorly Executed Race to the Court House vs. Robust Complaint Must be First to File to survive dismissal under Fed. R. Civ. P. 12(b)(1) Must plead with particularity to survive dismissal under Rules 12(b)(6) & a(b) One Amendment of Right Fed. R. Civ. P. 15 (a)(1)

35 35 BASIC PLEADING CONCERNS Which are the Proper Corporate Defendants? Which are the Proper Individual Defendants? Best practices for pleading defendants in a complaint Avoid at all costs use of proprietary, privileged, or HIPPA information.

36 36 THE COURT S ROLE IN THE PLEADING PROCESS Amendments as of Right (1) Fed. R. Civ. P. 15(a)(2) Amendments which require Court Permission Fed. R. Civ. P. 15 (a)(2) Amendments (dismissal) which Require Governments Permission Amendments which may require both Court Permission and Defendant s Permission Amendments Pre or Post Motions to Dismiss

37 37 False Claims Act/Qui Tam Whistleblower Litigation Involving Health Care Providers Friday, May 6, 2016 Private Causes of Action Accompanying FCA Qui Tam Cases Pamela C. Brecht

38 38 PRIVATE CAUSES OF ACTION WHICH MAY ACCOMPANY FCA QUI TAM CASES Friday, May 6, :45 a.m. 10:15 a.m. Pamela Coyle Brecht, Esquire PIETRAGALLO GORDON ALFANO BOSICK & RASPANTI, LLP 1818 Market Street, Suite 3402 Philadelphia, PA (215)

39 39 RELATOR S PRIVATE CAUSES OF ACTION AND RETALIATORY DISCHARGE CLAIMS Government Derivative Claims v. Private Claims Federal FCA 3730(h) and State Progeny Scope of Private or Semi-Private Claims

40 40 Derivative vs. Private Claims In Whistleblower Litigation Derivative Claim (US ex rel John Doe) = Relator s Share (15-30%) Statute creates Relator s right to recover qui tam pro domino rege quam pro se ipso in hac parte sequitur: "[he] who sues in this matter for the king as well as for himself. Relator brings the action on behalf of the federal Government Relator recovers only if the Government s claims are proved The range of Relator s share depends on the Government s decision whether to intervene or decline to intervene Relator s counsel s role in the litigation also depends on the Government s intervention decision Private Claims = Relator (100%) Both statutes and common law bases for Relator s recovery Relator brings claim on his own behalf Relator s recovery is not shared with the Government

41 41 Relator s Derivative Claims Under the Federal FCA Derivative Claim: Section 3730(b) Actions by private persons.-- (1) A person may bring a civil action for a violation of section 3729 for the person and for the United States Government. The action shall be brought in the name of the Government. The action may be dismissed only if the court and the Attorney General give written consent to the dismissal and their reasons for consenting. Relator s Share: Section 3730(d) Award to qui tam plaintiff. -- (1) If the Government proceeds with an action brought by a person under subsection (b), such person shall, subject to the second sentence of this paragraph, receive at least 15 percent but not more than 25 percent of the proceeds of the action or settlement of the claim, depending upon the extent to which the person substantially contributed to the prosecution of the action (2) If the Government does not proceed with an action under this section, the person bringing the action or settling the claim shall receive an amount which the court decides is reasonable for collecting the civil penalty and damages. The amount shall be not less than 25 percent and not more than 30 percent of the proceeds of the action or settlement and shall be paid out of such proceeds.

42 Additional Derivative Claims State False Claims Acts (FCA): Relator s Share Other Federal Whistleblower Programs IRS Whistleblower SEC Whistleblower State Insurance Code Violations California Illinois 42

43 43 Relator s Private Causes of Action Relators often suffer personally and in their employment, profession, or business relationships. Relators have personal statutory claims under federal and state FCAs. Relators may file pendant private causes of action simultaneously, under seal, with federal or state qui tam claims. Pendant state claims can be statutory or based in common law. Personal claims provide opportunities for creativity to make the Relator whole.

44 Relator s Personal Causes of Action Federal FCA Anti-Retaliation, Section 3730(h) and State Progeny Attorneys Fees and Costs under Federal and State FCAs Other Statute-based Claims Common Law Claims Damages 44

45 45 Federal FCA Anti-Retaliation and State Progeny Federal FCA Anti-Retaliation Provision 31 U.S.C 3730(h), Relief From Retaliatory Actions. (1) In general. Any employee, contractor, or agent shall be entitled to all relief necessary to make that employee, contractor, or agent whole, if that employee, contractor, or agent is discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against in the terms and conditions of employment because of lawful acts done by the employee, contractor, agent or associated others in furtherance of other efforts to stop 1 or more violations of this subchapter.

46 46 Relator s Claim for Attorney Fees and Costs Under the FCA 31 U.S.C. 3730(d) Award to qui tam plaintiff, (1) and(2): [s]uch person shall also receive an amount for reasonable expenses which the court finds to have been necessarily incurred, plus reasonable attorneys' fees and costs. All such expenses, fees, and costs shall be awarded against the defendant. State FCAs provide for similar relief

47 47 Other Statutory Pendant Claims Federal Pendant Claims Pendant or follow-on claims Anti-trust litigation and Follow-on qui tam, US ex rel Radice v. Astellas Pharma (C.D. Cal.) Part D and Medicaid programs overpay because pay-for-delay settlements between manufacturers in anti-trust cases intentionally inflate prices. Qui Tam and Follow-on Shareholder Class Action Relator counsel is not barred from participating. Mahoney v. Endo Health (S.D. NY), 4/25/16 Pendant Claims Based on State Laws Unfair and Deceptive Trade Practices State-laws other than FCAs prohibiting retaliation in the work place Check conflicts with federal laws

48 48 Relator s Common Law Claims Pendant Claims Based in Common Law Thinking Outside the Box Breach of contract Intentional infliction of emotional distress Defamation Tortious interference with a contract

49 49 Damages for Private Causes of Action Actual Damages Breach of Contract Common law torts Intentional Infliction of Emotional Distress Tortious Interference with Contractual Relationship: Defamation/Slander Per Se Punitive Damages: willfully evidences a reckless and wanton disregard of the plaintiff's rights Intentional Infliction of Emotional Distress Tortious Interference with Contractual Relationship Defamation/Slander Per Se Potential for treble damages under some state law, i.e., North Carolina Unfair and Deceptive Trade Practices Act, N.C. Gen. Stat , Attorney s fees, i.e., Unfair and Deceptive Trade Practices Act violations

50 Relator s Personal Causes of Action (RECAP) Claims Under Federal and State FCAs: Anti-Retaliation Provisions Relators Attorneys Fees and Costs Pendant Claims Based on Federal Laws Anti-trust litigation Shareholder suits Pendant Claims Based on State Laws Unfair and Deceptive Trade Practices State-laws other than FCAs prohibiting retaliation in the work place Check conflicts with federal laws Pendant Claims Based in Common Law Thinking Outside the Box Breach of contract Intentional infliction of emotional distress Defamation Tortious interference with a contract 50

51 Questions? QUESTIONS? 51

52 52 HEALTH CARE FCA QUI TAM CASES HOT TOPICS FROM THE PLAINTIFF S PERSPECTIVE May 6, :30 a.m. 11:15 a.m. Marc Stephen Raspanti, Esquire PIETRAGALLO GORDON ALFANO BOSICK & RASPANTI, LLP 1818 Market Street, Suite 3402 Philadelphia, PA (215) msr@pietragallo.com Pamela Coyle Brecht, Esquire PIETRAGALLO GORDON ALFANO BOSICK & RASPANTI, LLP 1818 Market Street, Suite 3402 Philadelphia, PA (215) pcb@pietragallo.com

53 53 False Claims Act/Qui Tam Whistleblower Litigation Involving Health Care Providers Friday, May 6, 2016 Health Care FCA Qui Tam Cases: Hot Topics from the Plaintiff s Perspective Joseph P. Griffith, Jr. Pamela C. Brecht James C. Leventis, Jr. Hon. William N. Nettles Marc S. Raspanti Elizabeth C. Warren

54 54 False Claims Act/Qui Tam Whistleblower Litigation Involving Health Care Providers Friday, May 6, 2016 Stark Law Update Dan Mulholland

55 55 Stark Update South Carolina Bar CLE May 6, 2016 Dan Mulholland Horty, Springer & Mattern 4614 Fifth Avenue, Pittsburgh, PA

56 56 How Stark Works DHS Entity Bill Medicare (for DHS) Referral for DHS $$$ Relationship Or family member Exception

57 If physician refers Medicare/Medicaid beneficiary to the entity for DHS, the entity may not submit a bill to Medicare or Medicaid for DHS If bill is submitted to Medicare/Medicaid, the claim will not be paid and any payment made must be refunded Administrative CMP up to $15,000/claim Claim may also be considered to be a false civil money penalty claim + exclusion from Medicare Also subject to qui tam suits 57

58 Evolution of Stark Phase III Phase I Phase II Stark II Stark I

59 New Stark Regulations 80 Fed Reg (11/16/15) Non-physician practitioner recruitment Timeshare arrangements Physician-owned hospital requirements Stand-in-the-shoes rule clarifications Writing can be a collection of documents 59

60 60 New Stark Regulations 2015 Term of lease or PSA need not be in writing if the arrangement lasts at least one year Expired leases and PSAs can continue indefinitely on the same terms 90-day grace period to obtain missing signatures Can give physicians items used solely for purposes identified in the statute

61 New Stark Regulations 2015 No financial relationship when physician provides services to hospital patients in the hospital if hospital and physician bill independently Updates obsolete language in references to publicly traded entities and locum tenens Geographic service area for FQHCs and RHCs for physician recruitment exception 61

62 Notable Recent Cases 62

63 63 United States ex rel. Drakeford v. Tuomey, 792 F.3d 364 (4 th Cir. 2015) 4 th Circuit affirmed $237.5 M jury verdict Gov t challenged FMV and commercial reasonableness of part time physician employment contracts Also said that compensation varied with or took into account volume or value of referrals Damage award held not excessive under 8 th Amendment and based on any claim where physicians listed as attending or operating physician on claims form Rejected advice of counsel defense Settled for $72.4M on 10/16/15

64 64 Judge Wynn s concurring opinion in Tuomey: I am troubled by the picture this case paints: An impenetrably complex set of laws and regulations that will result in a likely death sentence for a community hospital in an already medically underserved area. In the context of the Stark Law, it is easy to see how even diligent counsel could wind up giving clients incorrect advice. It seems as if, even for well-intentioned health care providers, the Stark Law has become a booby trap rigged with strict liability and potentially ruinous exposure especially when coupled with the False Claims Act.

65 65 United States ex rel. Baklid-Kunz v. Halifax Hospital Medical Center, (M.D. Fla. 3/11/14) Hospital system agreed to pay $85M to settle qui tam suit Alleged to have violated Stark Law by paying six medical oncologists incentive bonus that included the value of prescription drugs and tests Also alleged that three neurosurgeons paid more than FMV District Court ruled that Halifax s contracts with oncologists violated the Stark Law; case settled on eve of trial Relator was administrative head of practice group who continued to be employed throughout litigation

66 United States ex rel. Barker v. Columbus Reg l Healthcare System (M.D. Ga. 9/4/15) Relator alleged that: Columbus Regional oncologists improperly billed government for E&M services; Oncologist at the improperly billed government payors for IMRT; Columbus Regional overpaid for its purchase of the cancer center; and Relationship with a radiation oncology group violated the Stark Law. 66

67 United States ex rel. Barker v. Columbus Reg l Healthcare System Columbus Regional settled all claims against it for $25M, plus a possible contingent payment in the future. Settlement amount was reached based on Columbus Regional's ability to pay and does not represent the full value of the claims. 67

68 United States ex rel. Barker v. Columbus Reg l Healthcare System Relator s share determined to be $5,337,000 Relator asked for $6,737,625 Government argued he was entitled to $4,524, WL (M.D. Ga. Mar. 28, 2016) 68

69 69 United States ex rel. Schaengold v. Memorial Health, Inc. (S.D. Ga. 12/23/15) Memorial Health agreed to pay $9.8M to settle qui tam suit Relator was former CEO Alleged Stark Law and Anti-Kickback Statute violations based on physician contracts that resulted in significant operating losses System had paid $5M a few years before to settle similar allegations, which included OIG Certification of Compliance Agreement

70 70 United States ex rel. Schaengold v. Memorial Health, Inc. New allegations involved paying PCPs above FMV to shift patient admissions and referrals from competitor Pro forma projected that the acquisition of PCP practice would result in loss of $650,000 a year Losses totaled $3M over 30 months; docs paid $1.5M over FMV Bonuses allegedly based on value of referrals and collections for DHS

71 71 United States ex rel. Payne v. Adventist Health Sys./Sunbelt, Inc. (W.D.N.C. 9/21/15) Nonprofit health care system agreed to pay $118.7M to settle qui tam suit Allegedly purchased physician practices and paid employed physicians excessive compensation Also allegedly offered perks such as paying off a physician s car, forgiving compensation penalties and providing full-time salary to part-time physician compensation allegedly above FMV and losses totaling $21.7M over 3 years complaint alleged that system allegedly kept track of referrals and pressured underperforming physicians to refer

72 72 United States ex rel. Reilly v. North Broward Hospital District (S.D.Fla. 9/15/15) Florida hospital district agreed to pay $69.5M to settle qui tam suit Alleged that Broward paid physicians in excess of FMV with net loss over $17M Allegedly offset losses with hospital profits of $28M Alleged that hospital secretly tracked referrals and used this data to pay doctors more

73 73 United States ex rel. Parikh v. Citizens Med. Ctr., 977 F. Supp. 2d 654 (S.D. Tex. 2013), aff d 762 F.3d 461 (5th Cir. 2014) Settlement 4/21/15 County hospital agreed to pay $21.8M to settle qui tam suit Allegedly had bonus program for physicians that referred patients and paid employed physicians over FMV District Court denied hospital motion to dismiss the relators Stark Law claims involving compensation agreements because relator alleged that physicians systematically lost money Fifth Circuit affirmed the district court s decision, ultimately leading to settlement

74 74 Council for Urological Interests v. Burwell 790 F.3d 212 (D.C. Cir. 2015) Association of doctor-owned equipment lessors brought action challenging Stark regulations that effectively prevented physicians who leased medical equipment to hospitals from referring their Medicare patients to those same hospitals for outpatient care involving that equipment. Court held that:

75 75 Council for Urological Interests v. Burwell 790 F.3d 212 (D.C. Cir. 2015) Secretary was not barred by Stark Law from prohibiting physicians from charging hospitals for leased equipment on per-use basis Regulation barring physicians from charging hospitals for leased equipment on per-use basis for procedures using that equipment was unreasonable interpretation of Stark Law Regulation redefining entity furnishing designated health services was reasonable construction of Stark Law; and Secretary s certification that proposed regulations would not have significant economic impact on substantial number of small entities satisfied Regulatory Flexibility Act.

76 76 Ameritox, Ltd. v. Millennium Labs., Inc., 803 F.3d 518 (11th Cir. 2015) Drug-testing company alleged that competitor formed a business plan to increase its market share, revenue, and profits by providing financial inducements and other kickbacks, in violation of Stark Law and antikickback statute. District Court granted summary judgment in part for plaintiff. 11 th Circuit vacated and remanded.

77 77 United States v. Organon USA Inc., No WL (D. Mass. Aug. 17, 2015) Expert testimony of Kevin McAnaney offered on five topics:

78 78 1. Whether discounts and rebates offered by former defendant Organon to defendant Omnicare, Inc. (the report's proponent) for certain Organon drug products were common, usual, and customary in the pharmaceutical industry during the relevant time period. 2. What questions would be addressed and what materials were available and would have been considered during the relevant time period in determining whether the discounts and rebates violated the Anti Kickback Statute.

79 79 3. Whether companies in the health care industry, experienced health care attorneys, and regulators would have reasonably believed that the discounts and rebates complied with the statutory discount exception. 4. Same as #3 with respect to the 1999 regulatory safe harbor for discounts. 5. Whether companies in the health care industry, experienced health care attorneys, and regulators reasonably would have believed that the discounts and rebates contravened the AKS.

80 80 United States v. Organon Court granted relator s Daubert motion on all but topic #2, holding McAnaney not qualified to opine on pharma industry issues and that other testimony was speculative.

81 81 Intermountain Stroke Ctr., Inc. v. Intermountain Health Care, Inc., 2016 WL (10th Cir. Feb. 9, 2016) Health system s claim in its Ethics Code that it carefully reviews financial relationships with physicians and other Health Care Practitioners for compliance with the anti-kickback and Stark laws did not constitute false advertising under the Lanham Act even though system had previously entered into a settlement with Government.

82 82 More Changes to Come? CMS Notice of Proposed Rulemaking 80 Fed. Reg (7/15/15): We are soliciting comments regarding the impact of the physician self-referral law on health care delivery and payment reform. We are interested in comments regarding perceived barriers to achieving clinical and financial integration posed by the physician self-referral law generally and, in particular, the volume or value and other business generated standards set out in our regulations.

83 We are also interested in learning whether stakeholders see a need for guidance on the application of our regulations as they relate to physician compensation that is unrelated to participation in alternative payment models. On this subject, we specifically solicit comments regarding the volume or value and other business generated standards, but welcome comments regarding any of our rules for determining physician compensation. 83

84 To encourage robust commentary from stakeholders, we pose the following topics and questions for discussion: Does the physician self-referral law generally and, in particular, the volume or value and other business generated standards set out in our regulations, pose barriers to or limitations on achieving clinical and financial integration? If so, are the barriers or limitations more pronounced for hospitals than for other providers or suppliers because all Medicare revenue is from DHS (and, thus, any compensation might be considered to take into account the volume or value of referrals or other business generated by the physician to whom it is paid)? 84

85 CMS Walks it Back Fed. Reg Comment: We received several comments, including suggestions on policy changes that are outside the scope of this rulemaking. For example, one commenter requested revisions to the inoffice ancillary services exception. Another commenter requested that we make regulatory protections for electronic health records permanent. We also received a few requests that the physician self-referral law be eliminated entirely. In addition, some commenters described their interpretations of various physician selfreferral issues or asked questions about existing regulations. 85

86 CMS responds: Response: Although we appreciate the commenters taking the time to present these positions, these comments are beyond the scope of this rulemaking and are not addressed in this final rule with comment period. We express no view on these issues; our silence should not be viewed as an affirmation of any commenter s interpretations or views. If these issues are addressed in the future, we will publish a notice of proposed rulemaking that will be open to public comment at that time. 86

87 87 False Claims Act/Qui Tam Whistleblower Litigation Involving Health Care Providers Friday, May 6, 2016 False Claims Act Case Updates: Ambulance Companies J. Brady Hair

88 88 South Carolina Bar CLE: False Claims Act/Qui Tam Litigation FALSE CLAIMS ACT UPDATE AMBULANCE FRAUD Prepared by J. Brady Hair 1

89 89 I. AMBULANCE COMPANY FRAUD CASE UPDATE Page 1. OVERVIEW a.) b.) WHY IT MATTERS TO THE GOVERNMENT WHY IT MATTERS TO THE AMBULANCE COMPANIES IT S ALL ABOUT THE MONEY..TO BOTH!! 2. THE RULES-FEDERAL AND STATE a.) EMERGENCY SERVICES b.) NON-EMERGENCY SERVICES i.) TAXI ii.) FREE RIDE c.) THE TARGETS i.) DIALYSIS CLINICS ii.) NURSING HOMES d) SPECIAL RULES FOR 3 STATES----INCLUDING SOUTH CAROLINA, PENNSYLVANIA AND NEW JERSEY a.) CMS PRE-CERTIFICATION PROGRAM BEGAN DECEMBER 1,2014 b.) WHAT THE GOVERNMENT SAYS c.) WHAT THE AMBULANCE COMPANIES SAY 3. RECENT FCA SETTLEMENTS 4. RECENT CRIMINAL PROSECUTIONS 5. RECENT REPORTED CASES 2

90 90 1. OVERVIEW IT S ALL ABOUBT THE MONEY!!!! Headlines around the country proclaim that Non- Emergency Ambulance Services cost the Medicare program hundreds of millions of dollars in fraudulent billing. The OIG estimates as much as $350 million of fraudulent billing occurred in For example, a 2015 online article reported: Assistant special agent for the Office of Inspector General (OIG), Ron Kerr, told the news organization that businesses treat ambulances like a glorified taxi service, often transporting patients who are healthy enough to drive themselves and then billing Medicare for as much as $ round trip. Ambulance companies target dialysis patients who require transportation multiple times each week--a scam that ultimately costs Medicare more than $60,000 per patient. Kerr added that drivers often search for patients in lobbies or waiting rooms, and then pay them with gifts or cash to ride in the ambulance, allowing the company to bill Medicare for the service. Recruiting just 20 patients who use the service multiple times each week accumulates more than $1 million in annual revenue. Some of the fraudsters that enter into the ambulance fraud may have been drug dealers at one point but it is just more lucrative to get involved in healthcare fraud, Kerr told ABC News, adding that Medicare is a $600 billion program. It is where the money is. See 3

91 91 SAME OLD SCAM.SAME OLD STORY. Ambulance billing fraud is not a new scam. In fact, the Government has been battling for over 20 years to get Non-Emergency Ambulance Services under control: Medicare Pays Millions in Ambulance Overbilling, Report Says By ROBERT PEAR Published: November 9, 1997 WASHINGTON, Nov. 8,1997 Federal investigators, having documented many instances of overbilling and false claims by ambulance operators, say that Medicare wastes hundreds of millions of dollars a year by paying for unnecessary ambulance services provided to elderly patients. In a new draft report, the Inspector General of the Department of Health and Human Services, June Gibbs Brown, said that ambulance companies frequently billed Medicare for ''medically unnecessary transportation.'' In addition, the report documents how some ambulance companies falsified ''destination information'' and charged the Government for supplies and services that were not needed or not provided. The Inspector General said that more than 100 providers of ambulance services had been cited for civil or criminal violations of Medicare laws in the last five years. Medicare's system of paying for ambulance services, she said, is so complex that it ''encourages fraud and abuse and thwarts efforts to control expenditures. See 4

92 92 BIG BUSINESS IN SOUTH CAROLINA THE STATE newspaper recently reported that ambulance services were at the top of the list of Medicare Billings in South Carolina. Ambulance services, cancer doctors top Medicare payment list April 9, 2014 By JOEY HOLLEMAN - jholleman@thestate.com Eight of Medicare s 10 highest payments to health care entities in South Carolina for services in 2012 were in one specialty ambulance service. This data shows where we are spending the most money, said Tony Keck, director of the S.C. Department of Health and Human Services. It doesn t necessarily mean it s a problem that a big chunk of the money is being paid to any one company or one physician. It shouldn t be a surprise that the top of the South Carolina list is dominated by ambulance services. A lot of our business is dialysis transportation, said Randy Guyton, owner of Gaffney-based AmbuStar, which received $2.81 million in Medicare payments in We take them in stretchers or in wheelchairs to get treatment. In a state with some of the highest rates of diabetes, which often leads to kidney failure, dialysis treatment is big business. AmbuStar also takes many elderly patients from their homes to hospitals or from nursing home to doctor visits. We do everything that EMS doesn t do, Guyton said. And most of his business involves handling either the elderly covered by Medicare or the poor covered by Medicaid. That s common in South Carolina. Seventeen of the top 30 Medicare payments in the state in 2012 went to ambulance companies. The top five were Personal Care in Charleston ($5.42 million in payments), Qzo Inc. in Aiken ($5.36 million), Carolina Medicare in Florence ($4.93 million), Medshore Ambulance Service in Anderson ($4.79 million) and Regional Ambulance Service based in the Aiken County town of Warrenville ($4.65 million). See 5

93 93 2. THE RULES Even though our focus today is on Medicare FCA cases, keep in mind the State, because of Medicaid, is a big player in these cases. Rest assured that if you have a Federal Medicare problem, you have a State Medicaid problem. You will be dealing with the U.S. Attorney s office for Medicare and the State Attorney General s Office for Medicaid. Everything you ever wanted to know about Ambulance transportation rules and reimbursement procedures can be found in a handy booklets published CMS and by the South Carolina Department of Health and Human Services. Both are excellent sources of information. You can download them. See Guidance/Guidance/Manuals/downloads/bp102c10.pdf This covers the Federal Medicare regulations regarding Ambulance reimbursement. The rules are almost exactly like the Medicaid Rules. The manual is long and covers all aspects of Medicare/Medicaid issues. The General Rule for reimbursable Ambulance transports is the same as most other Health Care Services The Service must be MEDICALLY NECESSARY! In this area, medically necessary means the service COULD NOT BE PROVIDED by any other transportation means without endangering the beneficiary. Guidance can be found in South Carolina s Ambulance Services Provider Manual. The South Carolina Medicaid program sponsors transportation to Medicaid covered services in three ways: through the Broker model, for non-emergency transportation (ground and air), outside the Broker model, fee-for-service, emergency transportation, Manage Care Organizations (MCOs) and the Medical Home Networks - Medically Complex Children s Waiver (MCCW) for beneficiaries enrolled in a manage care plan. The South Carolina Medicaid program will sponsor only medically necessary ambulance transportation. Ambulance fee-for-service transportation is considered medically necessary if the following conditions exist: 6

94 is called and the beneficiary is transported in an emergency situation (e.g., as a result of an accident, injury, or acute illness), and any other method of transportation is inappropriate. The Department of Health and Environmental Control (DHEC) approved Ambulance Run Report justifies the emergency conditions and/or treatment of the level of service billed. Payment will not be made for ambulance service in a case where another means of transportation could be utilized without endangering the beneficiary s health. For example, if a beneficiary is not transported in any emergency situation, the beneficiary should be instructed to contact the broker. %202.pdf MEDICAID COVERS TRANSPORTATION FOR SOME NON-EMERGENCY VISITS THROUGH THE BROKER SYSTEM. The Broker or Brokers are awarded a contract from the State Agency that manages the Medicaid Program. Here s a description of the services that are allowed and those most abused by Ambulance Companies: This information should assist providers to answer telephone calls from beneficiaries who are not eligible for ambulance services outside of the Medicaid Broker. If a beneficiary does not meet the criteria for emergency transportation, they should be instructed to call the non- emergency transportation broker in the county in which they reside. The broker will provide Medicaid transportation services for the following: All non-emergency ambulance transportation to medical appointments and non-emergency transports which are planned/scheduled trips. Transports from a nursing home to a physician s office, a nursing home to a dialysis center, or hospital to residence. Non-emergency transportation for beneficiaries requiring stretcher or wheelchair service. 7

95 95 Non-emergency transportation services to beneficiaries traveling out of state for prior authorized medical services, (e.g., lodging, meals, etc). Non-emergency air transports for both Rotary and Fixed Wing air flights. Transportation for beneficiaries who receive retroactive eligibility. For the above and additional information, See A. SPECIAL RULES IN SOUTH CAROLINA DECEMBER 1, 2014 Because of the high incidence of fraud some States, including South Carolina, have been required to participate in a pilot program requiring Pre- Certification for Medicare ambulance transports. This has been a highly controversial program. The Government says it reduces fraud, while the operators say it denies patients vital health services. Medicare launches controversial pilot program in South Carolina to save money on ambulance transports Lauren Sausser Dec A new Medicare pilot program requires private ambulance companies to seek pre-approval before transporting many dialysis patients to treatment. 8

96 96 Hundreds of diabetic patients across the state who rely on dialysis treatment for survival may be left at home this week if Medicare doesn't make quick fixes to a new pilot program it recently rolled out in South Carolina. What is dialysis? When your kidneys are healthy, they clean your blood. They also make hormones that keep your bones strong and your blood healthy, the National Institutes of Health explains on its website. When your kidneys fail, you need treatment to replace the work your kidneys used to do. Unless you have a kidney transplant, you will need a treatment called dialysis. Some diabetic patients who fail to manage their condition appropriately may experience kidney failure and require dialysis. There are such a small percentage of people that qualify for transplants, the majority of these folks are on dialysis for the rest of their life, said Josh Watts, owner of a Charleston-based private ambulance company. The American Kidney Fund estimates nearly 400,000 people in this country required some form of dialysis treatment in That program, which also launched this month in Pennsylvania and New Jersey, now requires private ambulance companies to seek prior permission before transporting Medicare patients for nonemergency, routine care. See The program has received mixed reviews. Some operators say they like the program because they know, in advance if they will be paid. Others think it has unfairly eliminated services to medically needy persons. In South Carolina, the program has caused many Ambulance services to go out of business. For a good summary of the program go to: 9

97 97 3. RECENT FCA SETTLEMENTS The Government continues to collect millions of dollars from Ambulance companies under the False Claims Act. Qui Tam cases filed by whistleblowers can result in multi-million dollar settlements. Many of the settlements allege overbilling for non-emergency based transports that were not medically necessary. Oftentimes the ambulance companies bill for the non-emergency transport of patients for what is considered convenience trips. These patients have been videotaped walking to the ambulance and sometimes even riding up front A relatively new scheme involves swapping schemes. The ambulance companies offer a discount for regular services to nursing homes under Medicare Part A in exchange for lucrative Part B transports. This swapping arrangement violates the Anti-Kickback Statute. Department of Justice U.S. Attorney s Office Southern District of California FOR IMMEDIATE RELEASE Monday, May 4, 2015 Five Southern California Ambulance Companies To Pay More Than $11.5 Million To Resolve Kickback Allegations Whistleblower Suit Alleges swapping Kickback Scheme SAN DIEGO In a lawsuit unsealed in federal court today, five ambulance companies have entered into civil settlements with the Department of Justice requiring them to collectively pay more than $11.5 million in payments to the United States to resolve kickback allegations. The settling defendants include three Orange-County based companies - Pacific Ambulance, Inc. and Bowers Companies, Inc., (both of which were subsequently acquired by Rural/Metro Corporation after the alleged misconduct occurred) and Care Ambulance Service, Inc.; and two San Diego-based companies - Balboa Ambulance Service, Inc., and E.R. Ambulance, Inc. The settlements resolve allegations that the defendants engaged in so-called swapping kickback schemes by providing deeply 10

98 98 discounted and often below cost ambulance services to hospitals and/or skilled nursing facilities in exchange for exclusive rights to the facilities more lucrative Medicare patient referrals. Such swapping arrangements can lead to overutilization of medical services and inflated charges to the Medicare program. The government alleges that the arrangements in this case resulted in false claims for Medicare Part B transports which in essence subsidized the discounted trips. The Anti-Kickback Statute prohibits payment arrangements that are intended to influence health care referrals. The statute generally prohibits anyone from offering, paying, soliciting or receiving remuneration to induce referrals of items or services covered by federal health care programs, including Medicare. Department of Justice U.S. Attorney s Office Middle District of Florida FOR IMMEDIATE RELEASE Friday, May 8, 2015 United States Settles False Claims Act Allegations Against Multiple Jacksonville Hospitals And An Ambulance Company For $7.5 Million Jacksonville, FL United States Attorney A. Lee Bentley, III announces that the United States has settled allegations that nine hospitals in Jacksonville had a practice of routinely ordering basic life support ambulances when this type of transport was not medically necessary. The United States has also settled allegations with an ambulance company for its role in submitting millions of dollars of false claims to federal healthcare programs. The allegations resolved included liability under the False Claims Act (FCA). After a multiple-year investigation, the United States announces settlements with the following defendants: Baptist Health, who owns and operates four hospitals in Jacksonville (settlement of $2.89 million); Memorial Hospital, Specialty Hospital, Lake City Medical Center, and Orange Park Medical Center (collective settlement of $2.37 million); UF Health Jacksonville (settlement of $1 million); and Century Ambulance Service (settlement of $1.25 million). In reaching this settlement, the parties resolved allegations that, from January 1, 2009, until April 2014, the hospitals provided Certificates of Medical Necessity that attested to the need for basic life support, non- 11

99 99 emergency ambulance transports even when these transports were not medically necessary. Hospital staff that certify the medical need for services when they are in fact not medically necessary fail in their role as gatekeepers of valuable taxpayer-funded health care programs, said Chief Counsel to the Inspector General Gregory E. Demske of the U.S. Department of Health and Human Services Office of Inspector General. Today s settlement involved false claims submitted to Medicare,. Ambulance companies must ensure that services billed to federal healthcare programs are medically necessary and reasonable, said Chief Counsel Demske. Billing Medicare and Medicaid for transports that amount to taxpayer-funded taxi services will not be tolerated. Department of Justice U.S. Attorney s Office Southern District of Texas FOR IMMEDIATE RELEASE Wednesday, January 27, 2016 Ambulance Company Owners Agree to Pay More Than $245,000 to Resolve Kickback Allegations HOUSTON The former owner and operator of Houston-area ambulance company National Care EMS has agreed to settle allegations that he and the company provided kickbacks to various nursing facilities and hospitals in exchange for rights to the institutions more lucrative Medicare and Medicaid transport referrals, announced U.S. Attorney Kenneth Magidson. Mohammed Elsaleh, 27, of Sugar Land, formerly owned National Care EMS, which is no longer in business. The settlement calls for Elsaleh to pay $125,000 to resolve the swapping allegations made against him and the company. In addition, Elsaleh s brother, Husam Alsaleh, 29, also of Sugar Land, the owner and operator of a successor company also called National Care EMS has agreed to pay $120,000, plus interest, in furtherance of the settlement. This settlement send a message that any alleged kickback or improper relationship among providers will not be tolerated, said Magidson. We will continue to hold those accountable that attempt to detrimentally impact the integrity of our health care system. The Anti-Kickback Statute prohibits offering, paying, soliciting or receiving remuneration to induce referrals of items or services 12

100 100 covered by federal health care programs, including Medicare and Medicaid. The settlement announced today resolves allegations that Elsaleh and National Care EMS provided free and heavily discounted ambulance transports to various nursing facilities and hospitals in exchange for the institutions referral of other lucrative Medicare and Medicaid business to National Care EMS. This settlement sends a message to the health care industry that both sides of a swapping arrangement can be held responsible for their improper actions, not just the entity that actually bills Medicare or Medicaid for the services, said Demske. Any company or individual considering entering such schemes should understand that their actions may have serious legal and financial consequences. South Carolina Department of Justice Office of Public Affairs FOR IMMEDIATE RELEASE Monday, February 25, 2013 South Carolina Ambulance Company to Pay U.S $800,000 to Resolve False Claims Allegations Williston Rescue Squad Inc. has agreed to pay the United States $800,000 to resolve allegations that it violated the False Claims Act by making false claims for payment to Medicare for ambulance transports, the Justice Department announced today. Williston, based in Williston, S.C., provides ambulance transport services in the southwestern part of South Carolina. Billing Medicare for unnecessary ambulance transports contributes to the soaring costs of health care, said Stuart F. Delery, Principal Deputy Assistant Attorney General for the Civil Division. The Department of Justice is committed to pursuing companies that waste limited Medicare funds. Medicare fraud is stealing, and it is crippling America s health care system. We have doubled the number of attorneys working these cases in South Carolina. Take notice, if you are bilking the Medicare system designed to support our elders, we are working to find you. For the honest service providers, which is a greater majority of 13

101 101 the community, you can report fraud at MEDICARE, said William N. Nettles, U.S. Attorney for the District of South Carolina. 4. RECENT CRIMINAL CASES INVOLVING AMBULANCE COMPANIES Civil exposure is not the only issue Ambulance companies need to be concerned about. Criminal prosecutions often go hand in hand with the Civil FCA cases. Serious criminal sentences are based on the amount of fraud in many of these cases. Millions of dollars in fraud can lead to many months in Federal Prison. In a very recent case in Philadelphia, an EMT received a 37 month sentence for driving patients who could walk and falsifying records. Department of Justice U.S. Attorney s Office Eastern District of Pennsylvania FOR IMMEDIATE RELEASE Wednesday, March 9, 2016 Ambulance Company Employee Sentenced To 37 Months In Prison For Fraud PHILADELPHIA Fritzroy Brown, 39, of Philadelphia, PA, was sentenced today to 37 months in prison for a healthcare fraud scheme centering on Brotherly Love Ambulance, Inc. In addition to the prison term, U.S. District Court Judge Gerald J. Pappert ordered three years of supervised release, restitution in the amount of $2,015, to Medicare, restitution of $14,150 to the Commonwealth of Pennsylvania, and a $300 special assessment. Brown was a certified Emergency Medical Technician (EMT) with Brotherly Love. While employed by Brotherly Love, Brown transported patients who were able to walk and could travel safely by means other than ambulance and who, therefore, were not eligible for ambulance transportation under Medicare requirements. Brown and other conspirators falsified reports to make it appear that the patients needed to be transported by ambulance when he knew that the patients could be safely transported by other means and, in fact, many of them could walk. In addition, Brown and other conspirators paid kickbacks to patients to ensure that they would use Brotherly 14

102 102 Love Ambulance for services which were not medically necessary. The company also transmitted bills for ambulance services for patients who were not transported by ambulance, but whom Brown and others drove in personal vehicles. Brown and others completed documentation of these transports that made it appear that the individuals had been transported in an ambulance when they had not, and that misrepresented the medical care provided to and safety precautions taken for these patients. EMT Sentenced for Role in Ambulance Fraud Scheme U.S. Attorney s Office June 05, 2014 Eastern District of Pennsylvania (215) PHILADELPHIA Khusen Akhmedov, 23, of Philadelphia, Pennsylvania, and Lancaster, Pennsylvania, was sentenced today to 27 months in prison for his role in a health care fraud scheme involving Penn Choice Ambulance Inc., operating from Philadelphia, Huntingdon Valley, and Camp Hill, Pennsylvania. Akhmedov pleaded guilty on December 5, 2013, to conspiracy to commit health care fraud, false statements relating to health care matters, and paying kickbacks to patients, a total of 16 counts. Akhmedov, an EMT for Penn Choice, was indicted with Penn Choice owner Anna Mudrova and operators Yury Gerasyuk, Mikhail Vasserman, Irina Vasserman, Aleksandr Vasserman, and Valeriy Davydchik, all of whom have pleaded guilty. The scheme involved more than $3.6 million in fraudulent claims submitted to Medicare. The defendants conspired to defraud Medicare by recruiting patients who were able to walk and could travel safely by means other than ambulance and who therefore were not eligible for ambulance transportation under Medicare requirements. The defendants, and others acting on their behalf, falsified reports to make it appear that the patients needed to be transported by ambulance when the defendants knew that the patients could be transported safely by other means and that many of them walked to the ambulance for transport. The defendants, themselves or through others, paid illegal kickbacks to the patients as part of scheme. The defendants billed Medicare for these ambulance services as if those services were medically necessary, and, as a result of the fraudulent billing, the Medicare program sustained losses of 15

103 103 more than $1.5 million for this medically unnecessary method of transportation. Owners of Los Angeles Ambulance Company Sentenced in Medicare Fraud Scheme U.S. Department of Justice May 05, 2014 Office of Public Affairs WASHINGTON The owners of Alpha Ambulance Inc. (Alpha), a nowdefunct Los Angeles-area ambulance transportation company, have been sentenced in connection with a Medicare fraud scheme. Aleksey Muratov, aka Russ Muratov, 32, and Alex Kapri, aka Alex Kapriyelov or Alexander Kapriyelov, 56, were sentenced by U.S. District Court Judge Audrey B. Collins in the Central District of California to serve 108 months and 75 months in prison, respectively. Both Kapri and Muratov pleaded guilty on October 28, 2014, to conspiracy to commit health care fraud. Muratov and Kapri were owners and operators of Alpha, which specialized in the provision of non-emergency ambulance transportation services to Medicare-eligible beneficiaries, primarily dialysis patients. According to court documents, Muratov and Kapri knowingly provided non-emergency ambulance transportation to Medicare beneficiaries whose medical condition at that time did not require ambulance transportation. With Kapri s knowledge, Muratov and others at Alpha instructed certain Alpha employees to conceal the Medicare beneficiaries medical conditions by altering required documents for Medicare reimbursement and creating fraudulent justifications for the transportation. The defendants caused Alpha to submit claims to Medicare that were fraudulent because the transportation was not medically necessary. Additionally, as the defendants were submitting these false claims, Medicare notified Alpha that the company would be subject to a Medicare audit. In response, Muratov instructed Alpha employees with Kapri s knowledge to alter specific documents that would be submitted to Medicare in response to the audit and create false justifications for transportation of the beneficiaries identified. 16

104 104 From at least June 2008 through at least July 2012, Alpha submitted more than $49 million in claims for ambulance transportation. As a result, Medicare paid Alpha more than $13 million for these claims, many of which were fraudulent. 5. RECENT REPORTED CASES U.S. v.louthian, 756 F.3d 295 (4 th. Cir. 2014) In a recent Fourth Circuit opinion, the Court upheld criminal convictions of an ambulance company owner for health care fraud, making false statements and committing perjury. The FBI did an undercover investigation where they videotaped several dialysis patients being picked up from their homes and then transported by ambulance. All three of the patients were ambulatory. One lady was videotaped getting off the stretcher at her door and then getting into her car and subsequently driving into town to go shopping. Other patients were videotaped walking to the ambulances and even climbing into the open doors. The court analyzed the evidence presented by the prosecution and determined it to be more than sufficient to uphold the convictions. This is a good case to review to show the standard fraud of billing for nonmedically necessary ambulance services. U.S. v. Conner No (4 th cir. 2008) In an interesting unpublished opinion, U.S. v. Conner, 262 Fed.Appx. 515, 2008 WL (4 th cir. 2008)(unpublished) the Court confirmed a 151 month sentence including a two level enhancement for an abuse of a position of trust. Even though the Court acknowledged, the Government, not the patients was the victim, it held that service providers owe a fiduciary duty to the Medicare program. Reimbursed medical providers have been held subject to the abuse of trust enhancement by other circuits. See United States v. Erhart, 415 F.3d 965, (8th Cir.2005) (enhancement properly applied to chiropractor who submitted fraudulent bills to insurance companies); United States v. Hodge, 259 F.3d 549, 556 (6th Cir.2001)(enhancement properly applied to manager 17

105 105 and treating therapist who falsely billed insurance companies); United States v. Hoogenboom, 209 F.3d 665, 666, 671 (7th Cir.2000) (enhancement properly applied to psychologist who falsely billed Medicare); United States v. Gieger, 190 F.3d 661, 663, 665 (5th Cir.1999) (enhancement properly applied to ambulance transportation service provider who made fraudulent claims to Medicare); United States v. Iloani, 143 F.3d 921, (5th Cir.1998) (enhancement properly applied to chiropractor who submitted fraudulent claims to insurance companies). Indeed, we have upheld the abuse of trust enhancement applied to a nursing home operator who perpetrated a fraud scheme against Medicaid. United States v. Bolden, 325 F.3d 471, (4th Cir.2003). Conner seeks to distinguish our Bolden decision from his case because in Bolden the nursing home operator received prospective payments from Medicaid, subject to later cost reporting by the operator. Id. at We relied on that entrustment as evidence of the underlying trust relationship. Id. at Nevertheless, we also pointed out that [b]ecause of the discretion Medicaid confers upon care providers... such providers owe a fiduciary duty to Medicaid. Indeed, we see it as paramount that Medicaid be able to trust its service providers. Id. at 505 n. 41 (citation omitted and emphasis added). The facts of the present case are not significantly different. Conner was trusted (through his control of CTI) to properly report the medical necessity justifying ambulance service for Medicare and Medicaid patients. Because of the nature of these vast government programs, it is essential to their functioning that trust be imposed on the service provider to capably and honestly determine in the first instance which patient transactions are entitled to reimbursement. Otherwise, the added delay and expense might jeopardize the very existence of the programs. We find that the district court did not err in applying the twolevel enhancement. Id. 18

106 106 Other Cases of Interest US v. Hlushmanuk, 2014 WL (E.D. Pa. 2014) (Private Ambulance company billing for non-medically necessary trips given to ambulatory patients) Momentum EMS, Inc. v Sebelius, 2014 WL (S.D. Tx 2014)(Civil litigation over medical necessity of non-emergency ambulance transports.) US v. Elliot, 600 Fed. Appx. 225 (5 th Cir. 2015)(Owner of private nonemergency care ambulance service convicted of up-charging Medicare for services.) US v. Medlock, 792 F.3d 700 (6 th Cir. 2015)(Owners of non-emergency transport ambulance service convicted of billing Medicare for non-medically necessary trips and up-charging.) US v. Mudrova, 619 Fed.Appx. 149 (3 rd Cir. 2015)(Defendant fraudulently billed Medicare for medically unnecessary ambulance trips.) US. Climmons-Johnson, 619 Fed.Appx. 406 (5 th Cir. 2015) 19

107 107 False Claims Act/Qui Tam Whistleblower Litigation Involving Health Care Providers Friday, May 6, 2016 Managing a Health Care Provider s Response to an FCA Investigation Daniel J. Westbrook

108 108 MANAGING A HEALTH CARE PROVIDER S RESPONSE TO AN FCA Dan Westbrook Meredith Weinberg Nelson Mullins Riley & Scarborough LLP I. First Steps for Outside Counsel to Take: A. Send litigation hold letter to client. 1. If your client is under a governmental fraud investigation, the litigation hold letter should be formal and comprehensive. Make sure that the client takes appropriate steps to disseminate it to all employees who may have relevant information. 2. You may want to use the client s internal PR department or an outside PR consultant (retained by outside counsel) to help draft the hold letter, as long as that doesn t create a delay in sending the letter and the PR folks don t water the letter down. 3. You will need the client s internal IT staff or an outside IT consultant (retained by outside counsel) to help secure computer stored information. B. Contact the AUSA or agent in charge of the investigation. 1. The sooner you can establish a relationship with the investigators, the better. Try to establish a spirit of cooperation that works both ways. During the course of the investigation, which can take a long time, stay in touch with the other side. 2. Try to establish some ground rules and find out as much as you can about the scope and nature of the investigation: a) What are the concerns or allegations? b) Has a qui tam suit been filed? c) What evidence do they have? d) What employees have they interviewed? e) What employees do they plan to interview? f) Can you participate in the interviews? g) Are any individuals being targeted? 1

109 109 h) Are any subpoenas or a CID forthcoming? C. Protect confidential information. 1. As many lawyers have experienced, it s not uncommon for employees of a large company to send s and texts containing confidential information to each other and to outsiders without realizing they may be discoverable. An important early step is to educate employees about protecting confidential information. a) Employees need to be informed: (i) (ii) (iii) (iv) About the nature of investigations; Not to discuss issues related to the investigation with anyone outside the company; Report any relevant information they have to outside counsel; and Copy outside counsel on any written or electronic communications about matters related to the investigation. b) Use the most effective means possible to contact employees quickly. Depending on the company, that could be: (i) (ii) (iii) CEO or Compliance Officer memo Group meetings Mass s c) Whatever form it takes, the message should come from both management and outside counsel. d) Consider using the help of internal or external PR specialists, keeping in mind that external consultants should be retained by outside counsel. D. Outside counsel should retain any consultants. 1. Depending on the nature of the client and the investigations, various kinds of consultants may be useful: PR, billing, compliance, etc. It s 2

110 110 always better for outside counsel rather than the client to retain, supervise, and control a consultant: a) May help keep consultant communications privileged; and b) May help avoid competition between consultant and outside counsel. 2. Review drafts of any written reports by consultants. Make sure they contain no legal opinions. II. Civil and Criminal Investigations A. In your first conversation with the AUSA or agent in charge, ask if the investigation is civil, criminal, or both. B. If it s both, the client may need separate civil and criminal counsel. C. In any criminal investigation, the corporate client should consider hiring separate criminal counsel for individual employees most at risk for being targeted. 1. While individuals can hire criminal defense counsel themselves, having the employer hire them has advantages. a) Some individuals won t be able to afford attorneys. b) Having the employer select counsel may better ensure that all defense counsel are experienced, competent, and cooperative. c) While at some point client interests may diverge, at the start they are typically aligned. d) A team approach, with the employer s counsel serving as coordinator, usually works better than an every man for himself approach. e) Though paid by the employer, attorneys duty is to their clients. f) Joint defense agreement will help preserve attorney client privilege. 3

111 111 III. The Yates Memorandum A. September 2015 memorandum by DOJ Deputy AG Sally Yates entitled Individual Accountability for Corporate Wrongdoing. B. Yates factors: 1. Provide information on individuals or no cooperation credit. 2. Focus on individuals from inception of investigation. 3. Cooperation between civil and criminal investigation. 4. No release from individual liability in connection with corporate settlement. 5. No corporate resolution without a clear plan to resolve individual cases. 6. Ability to pay not a factor in considering individual civil cases. IV. The Course of a Government Investigation A. Lengthy and Expensive B. Document reviews 1. Investigators typically subpoena or issue a Civil Investigative Demand for a large volume of documents and s. Try to work with them to narrow the scope to reasonable limits. C. Investigator interviews 1. Government investigators typically interview employees with little or no notice, often by showing up at their front door in the evening. 2. Request notice of individuals or types of employees likely to be interviewed. 3. To the extent possible, hold individual prep sessions with employees likely to be interviewed. a) Try to allay their anxieties. 4

112 112 b) Don t encourage them to decline an interview, but let them know that, unless they are subpoenaed, their participation is voluntary. c) Instruct them to tell the truth, but as with depositions answer only the questions asked and do not volunteer unrequested information. 4. Request the right to participate in government interviews. If you re allowed to do so, try to agree on ground rules regarding such things as: V. Internal Investigations A. Pros and Cons a) The number of questioners; b) The type of questions allowed; c) Privileged information; and d) Attempts by investigators to intimidate the employee. 1. It s almost always better for outside counsel to conduct its own internal investigation, rather than simply to wait and see what the government turns up with. The major disadvantages of an internal investigation are its expense and the potential disruption to company morale and business. These risks are usually outweighed by the advantages of: B. Employee Interviews a) Identifying problems and preparing defenses; b) Determining if any individual employees may need separate counsel; c) Estimating potential civil and criminal exposure; and d) Recommending corrective actions. 1. Individual interviews are preferable to group interviews. 2. Consider off-site interviews, with one interviewer and one note-taker. 3. Be sure to tell the person being interviewed: a) Who the interviewer represents; 5

113 113 b) Whether the interview is privileged and who holds the privilege; c) The purpose of the interview is to discuss legal issues and gather information related to a government investigation; and d) The need for confidentiality. C. Internal and external communications 1. Outside counsel should consider relying on a PR specialist, either a client employee or a consultant retained by outside counsel, to assist with all communications related to the investigation with employees and outsiders. 2. Outside counsel and the PR team should prepare for worst case scenarios, e.g., a phone call from the media to the company or a front page story in the local newspaper. D. Types of corrective actions to consider 1. If your internal investigation reveals a client practice that is illegal, you obviously should make sure it stops. If you discover a practice that may or may not be illegal, you may want to stop it, but be aware that changing a practice could be interpreted as a tacit admission of its illegality. 2. An internal investigation may reveal that certain employees should be terminated or subject to other disciplinary actions. Outside counsel can make recommendations, but the client s HR department should make final decisions. 3. Internal investigations may reveal that the client should be reorganized in various ways. 4. If the investigation reveals that the government has been overbilled, the company has 60 days to notify authorities and offer repayment. E. Collaborative nature of an internal investigation 1. While outside counsel should control and direct the internal investigation, it must be clear to employees that management is fully supportive. A contact person or persons, such as a Compliance Officer, should work closely with outside counsel. 6

114 114 VI. Settlement or litigation? A. In most cases, the government will eventually lay its cards on the table (or some of them) and settlement discussions will begin. Obviously, you should try to convince the government to decline participating in the suit and leave the relator to fend for himself. If that doesn t work, you ll need evidence to show the AUSA that: 1. Any past problems were due to negligence, not fraud. Past problems have been fully corrected and an improved compliance program is in place. 2. Any overbilled amounts have been or will be repaid. 3. Unreasonable settlement terms will not be fair to your client and will not be in the public interest. 7

115 115 False Claims Act/Qui Tam Whistleblower Litigation Involving Health Care Providers Friday, May 6, 2016 False Claims Act Case Updates: Hospices Courtney E. Walsh

116 False Claims Cases and Decisions: Hospice A. United States v. AseraCare Inc, No. 2:12-CV-245-KOB, 2015 WL (N.D. Ala. Nov. 3, 2015) Background: Government brought action under False Claims Act (FCA) against hospice care provider, alleging false certification of patient eligibility for Medicare hospice benefits. Following a jury trial, provider brought motion for new trial. The Court granted the motion, holding that the jury should have been instructed that falsity could not be based solely on differences of clinical judgment. In addition to granting a new trial, the Court determined that it had the authority to and would consider sua sponte summary judgment of the matter. Discussion: As the Court describes the case, it has always been about whether AseraCare submitted false claims to Medicare by certifying patients as eligible for hospice who did not have a prognosis of a life expectancy of 6 months or less if the terminal illness runs its normal course. 42 C.F.R (b)(1). However, the Court made several key procedural and evidentiary determinations that shaped the trial s outcome to such an extent that the Court felt compelled to order a new trial. Jury instructions standard for falsity. The Court found that it provided instructions to the jury that did not accurately and completely reflect the legal standard for falsity in a FCA case, especially one involving the exercise of clinical judgment when making a prognosis of a patient's life expectancy. The court determined that it should have instructed the jury that demonstrating falsity under the FCA required proof of an objective falsehood. According to the Court, a mere difference of opinion among physicians, without more, is insufficient to show falsity under the FCA. More particularly, expressions of opinion, scientific judgments, or statements as to conclusions about which reasonable minds may differ cannot be false for purposes determining liability under the FCA. Applying this standard, the Court found the Government s evidence at trial insufficient to support a finding of falsity and granted ptovider s motion for a new trial. The only evidence of false claims the Government presented is [a physician s] opinion and the medical records that on their face contain information to which the expert medical doctors for each side pointed to support their conclusions as to whether each patient was eligible. In a footnote, the Court attempted to limit and explain the impact and meaning of its holding: [T]he court is not saying that a difference of opinions among treating physicians and medical experts would always defeat falsity in a FCA case, but that the Government would have to provide more evidence than just a medical expert who disagrees with the certifying physicians. Bifurcation and discovery issues. Impacting the substantive outcome were procedural and discovery issues which affected the Government s presentation of its case.

117 117 First, the Court decided to bifurcate the trial into two phases: one phase on the falsity element of the allegations, and a second phase on all other issues and claims, including the knowledge and damage elements. Second, the Court specifically limited the Government s proof of falsity (phase one) to medical expert testimony and the medical records at issue. The Court s limitation came in response to its perception of the Government s responses to interrogatories and requests. According to the Court, because the Government represented that it would only prove its case for falsity through medical expert testimony and medical records, the Court refused the Government s attempts to elicit testimony of falsity from other witnesses, such as relators and testifying clinicians. B. United States v. AseraCare Inc, No. 2:12-CV-245-KOB, 2016 WL (N.D. Ala. Mar. 31, 2016) Background: Despite having previously granted a new trial, the Court determined that it would sua sponte consider the matter for summary judgment. Discussion: In granting summary judgment to AseraCare, the Court affirmed its view that the Government had presented no evidence of an objective falsehood. Because a difference of opinion between physicians and medical experts about which reasonable minds could differ is all the Government has presented to prove falsity of the claims, the Government cannot prove the falsity element as a matter of law. In its opinion, the Court offered the following rationale in support of the view that medical expert opinion alone was insufficient: If the court were to find that all the Government needed to prove falsity in a hospice provider case was one medical expert who reviewed the medical records and disagreed with the certifying physician, hospice providers would be subject to potential FCA liability any time the Government could find a medical expert who disagreed with the certifying physician's clinical judgment. The court refuses to go down that road. The Court then offered examples of how the Government could have or should have challenged the certifications at issue. The Government does not challenge that each claim for each patient at issue had an accompanying [certification] with the valid signature of the certifying physician. Nor does the Government point the court to any evidence that any of the documents in the patients medical records were false; that any information on which the certifying physician relied was incorrect or false; or that the clinicians withheld information from the certifying physicians.

118 118 C. U.S. ex rel. Michaels v. Agape Senior Cmty., Inc., No. CA 0: JFA, 2015 WL (D.S.C. June 25, 2015), order corrected, No. CA 0: JFA, 2015 WL (D.S.C. July 6, 2015). Government authority to reject a settlement despite not intervening. In an action alleging false claims related to hospice care, Relator and Defendant Agape attempted to settle, agreeing upon a sum to be paid to Relators. Despite not intervening in the case, the Government exercised its authority under 31 U.S.C. 3730(b)(1) and withheld its consent to the proposed arrangement. Citing to the Ninth Circuit case of United States ex rel. Killingsworth v. Northrup Corp., 25 F.3d 715 (9th Cir.1994), Relator and Defendant argued that the Government could not unreasonably withhold its consent having not intervened. The Court, though noting its concerns with the Government s actions, concluded that the statute under consideration was plain on its face and contained no limitation on the Government s authority to object to such a settlement. Statistical Sampling. The Court also considered the issue of whether Relators would be allowed to prove damages by using a statistical sampling method. This method would involve the examination of a specified percentage of randomly selected claims. If a certain percentage of sampled claims were in fact fraudulent, then Relators would project that percentage on the total universe of claims submitted by Agape. The Court rejected the use of this damages model and held that the Relators would be required to prove each and every claim based upon the evidence relating to that particular claim. The Court noted that unlike cases in which evidence was destroyed or dissipated, the actual medical records at issue are all intact and available for review. Therefore, the Court concluded that statistical sampling was not appropriate. D. Druding v. Care Alternatives, Inc., No. CV (JBS/AMD), 2016 WL (D.N.J. Feb. 22, 2016). Background: Former employees of hospice care provider Care Alternatives ( provider ) brought an action against provider under the FCA and New Jersey False Claims Act, based on alleged false billing of Medicare, and engaging in conduct that violated the Stark Act and Anti- Kickback Statute. The Court issued this decision following Provider s motion to dismiss. False certification as a condition of payment. Defendant made the argument that Relators failed to allege any cognizable theory of fraud under either factual or legal falsity theories. The Court defined legal falsity as a FCA claim based on a false certification, meaning falsely certifying compliance with a statute or regulation which is a condition for Government payment. The Court notes the issue of whether hospice certification provisions of the Medicare statute and regulations are conditions of payment has not been addressed by the courts in that circuit. Ultimately, this Court held that hospice certifications are conditions of payment, and therefore can form the basis for liability under the FCA. Citing to the Medicate statute, the Court observed that the Medicare statute explicitly conditions payment for hospice care on a written certification from a medical professional accompanied by

119 119 supporting clinical documentation. Therefore, Relators can pursue false claims under an implied certification theory for violation of the Medicare statute and regulations. Violation of the Anti-Kickback Statute as a basis for alleging a False Claim. Relators also alleged that the Defendant presented false reimbursement claims when it implicitly certified that it was in compliance with [f]ederal laws and regulations designed to prevent or ameliorate fraud, waste, and abuse, 42 C.F.R , while at the same time violating the Anti-Kickback Statute ( AKS ) by inducing referrals. The Court reiterates that the Third Circuit has previously held that compliance with the AKS is a condition of payment for Medicare programs. Though the Court found Relator s allegation deficient in accordance the Rule 9(b) pleading standards, the Court affirmed the general proposition that compliance with the AKS is a condition of Medicare payment, and therefore can support an implied certification theory under the FCA. E. United States v. Southerncare, Inc., No. CV , 2015 WL (S.D. Ga. Sept. 9, 2015). Defendant Southerncare, a provider of hospice services, brought a Motion to Dismiss Relator's Second Amended Complaint for Failure to Plead Fraud with Particularity. Specifically, Defendant argued that Relator's second amended complaint failed to sufficiently allege the actual submission of false claims to the Government. The Court ultimately granted Defendant s motion in part and denied it in part. As the Court pointed out, the heightened pleading standard of Federal Rule of Civil Procedure 9(b) applies to claims brought under the FCA. With respect to several patients, the Relator alleges only that Defendant falsely billed the United State and Medicare. Because the Relators offered no other facts to support these conclusory allegations, the Court found that Relators had failed to plead their FCA claims with sufficient particularity as they pertain to these patients. In denying Defendant s Motion as it pertained to a different group of patients, the Court made clear that a FCA allegation need not plead exact billing data for each and every claim. To meet threshold sufficiency, the claim need only indicate the specific fraudulent services provided by defendant, when the services were provided, and further allege with particularity that Defendant submitted claims for such care. F. Cretney-Tsosie v. Creekside Hospice II, LLC, No. 213CV00167APGPAL, 2016 WL (D. Nev. Mar. 30, 2016). Background: The Court heard motions in this matter following of Government objections to Defendant Creekside Hospice II s Requests for Production. In its requests, Defendant had asked for: Identification of all patients the government contends were ineligible for hospice services and all supporting documentation to support such contention;

120 120 Identification of each false claim the Government contends the Defendants submitted or caused to be submitted to the Medicare program for reimbursement, including claim dates, name and address of person who submitted each claims, patient identification number, and the amount of the claim. The Government objected to these requests, contending that the requests sought production of materials that would be provided in expert disclosures due later. In an earlier Order, the Court directed the Government to produce the information with respect to the identification of the patients and the time periods for which the government believed false claims were made. The Government provided responses, but Defendant raised the mater of their sufficiency by making a Motion to Enforce. Discovery responses and impact on method of proof. In its response, the Government pointed to documents identifying particular patients that were the subject of false certifications, but did not provide the other information requested (specific claims, time periods, and certifications). In responding to the motion, the Government represented that it intended to prove both liability and damages through statistical sampling and medical opinion testimony. Because of its expert driven strategy for proving the allegations, the Government would not have the requested information until its experts conducted their analysis. Furthermore, because the Government would not undertake an analysis of the entire universe of claims on a patient-by-patient basis, some classes of requested information would never exist. Based on the Government s representations regarding its method of proof, the Court denied the Motion to Enforce. The Court also made clear that in light of the Government s representation that it would prove its claims via extrapolation of a statistically valid random sample, the Government will be precluded from altering its liability or damages theory and method of proof. The Court cautioned the Government that it would not be permitted a do over of discovery if the Court finds the Government's evidence or methodology lacking. G. United States ex rel. Fowler v. Evercare Hospice, Inc., No. 11-CV PAB-NYW, 2015 WL (D. Colo. Sept. 21, 2015) Background: Defendant Evercare Hospice brought Motions to Dismiss both the Government s Intervenor Complaint and Relator s Second Amended Complaint. In this matter, Government and Relator allege that Evercare violated the FCA by presenting claims for hospice care for individuals for whom Evercare knew that its medical records did not support a prognosis of terminal illness. Certification records as a precondition of payment. With respect to the Government s Complaint, Evercare argued that the Government failed to state a claim under the FCA, because the documentation requirement under the Medicare Regulations is a condition of participation rather than a condition of payment. Violation of a

121 121 condition of payment, because it would alter the Government s decision to make payment, can support an implied certification theory of a FCA violation. Looking to the language of the applicable Medicare regulations, the Court determined that the requirement that physicians' certifications are accompanied by clinical information and other documentation that support a patient's prognosis is a condition of payment under applicable Medicare statutes and regulations. Clinical judgment as objective falsity. Evercare next argued that both the Government and Relators failed to plead any false representation because the certifications relied on the clinical judgments of Evercare's certifying physicians, which judgments cannot be objectively false. The Court, however, immediately noted controlling appellate court decisions rejecting the argument that exercise of clinical judgment poses an absolute bar to FCA liability. Because the Government and Relators allege that physicians relied upon false information (whether provided knowingly or by way of reckless business practice), the allegations are susceptible to proof of truth or falsity.

122 122 Medicare Hospice Program Patients forego curative options in exchange for palliative care. Large percentage of hospice patients receive hospice benefits through the Medicare program. To be eligible for hospice care under Medicare, an individual must be: entitled to Medicare Part A; and certified as terminally ill in accordance with 42 C.F.R [42 C.F.R ]

123 123 Medicare Hospice Program A patient is considered terminally ill if he or she has a medical prognosis of life expectancy of six month or less. 42 U.S.C. 1395x. No payment may be made for any expenses or services, which are not reasonable and necessary for the palliation or management of terminal illness. 42 U.S.C. 1395y(a)(1)(c). Attending physician and facility medical director must both certify a patient s status as terminally ill based on their clinical judgment that life expectancy is 6 months or less if the terminal illness runs its normal course. 42 U.S.C. 1395f(a)(7)(A)(I); 42 C.F.R Clinical information and other documentation that support the medical prognosis must accompany the certification and must be filed in the medical record. 42 C.F.R Providers must re-certify patients at intervals. 42 C.F.R

124 2015 Hospice Settlements (DOJ Press Releases) Guardian agrees to pays $3 million to settle FCA allegations. (10/2/2015) U.S. ex rel. Betts, et al. v. Texas Home Health of America, L.P., et al., No. 1 12:CV-0412 (N.D. Ga.) Alive Hospice agrees to pay U.S. And Tennessee Over $1.5 Million. (9/10/15) United States ex rel. Anderson v. Alive Hospice, Inc., No. 3:12-cv (M.D. Tenn.) Serenity Hospice and Palliative Care to pay $2.2 Million. (10/7/2015) United States ex rel. Sifford v. Serenity Hospice and Palliative Care (CV PHX- GMS) Good Shepherd agrees to pay $4 million in connection with allegations that it submitted false claims for hospice patients who were not terminally ill. (2/6/15) United States ex rel. Cordingley and Jones v. Good Shepherd Hospice, Mid America, Inc., No. 4:11-cv-1087 (W.D. Mo.) St. Joseph Hospice entities agree to pay $5.86 Million. (9/3/2015) United States v. St. Joseph Hospice, et al., Case No. 1:12cv393 (S.D. Miss.) 124

125 125 United States v. AseraCare, Inc. [W]hether AseraCare submitted false claims to Medicare by certifying patients as eligible for hospice who did not have a prognosis of a life expectancy of 6 months[.] 42 C.F.R (b)(1). Proof of objective falsehood required. Differences of opinion among physicians, without more, is insufficient to show falsity under the FCA.

126 126 United States v. AseraCare, Inc. Court declared sua sponte it would consider summary judgment of the matter. Summary judgment in favor of AseraCare. (3/31/2016) If the court were to find that all the Government needed to prove falsity in a hospice provider case was one medical expert who reviewed the medical records and disagreed with the certifying physician, hospice providers would be subject to potential FCA liability any time the Government could find a medical expert who disagreed with the certifying physician's clinical judgment. The court refuses to go down that road.

127 U.S. ex rel. Michaels v. Agape Senior Cmty., Inc. 31 U.S.C. 3730(b)(1) contains no condition on the Attorney General s authority to object to a FCA settlement. Court concluded that statistical sampling was not appropriate in this case. Unlike cases in which evidence was destroyed or dissipated, the actual medical records at issue are all intact and available for review. 127

128 Druding v. Care Alternatives, Inc. Held that hospice certifications are conditions of payment, and therefore can form the basis for liability under the FCA. Compliance with the Anti-Kickback Statute is a condition of Medicare payment, and therefore can support implied certification theory under the FCA. 128

129 United States v. Southerncare, Inc. Pleading standard of Fed. R. Civ. P. 9(b) applies to causes of actions brought under the FCA. Threshold sufficiency under Rule 9(b) is met when an allegation indicates: The specific fraudulent services provided, When the services were provided, and Allege with particularity that Defendant submitted claims for such care. 129

130 Cretney-Tsosie v. Creekside Hospice II, LLC Requirement that physicians certifications are accompanied by clinical information and other documentation in support of a patient's prognosis is a condition of payment. Exercise of clinical judgment does not pose an absolute bar to FCA liability. Physicians alleged to have relied upon false information (whether knowingly or by reckless business practice); therefore, the allegations are susceptible to proof of truth or falsity. 130

131 U.S. ex rel. Drakeford v. Tuomey Not a Hospice related case but includes timely discussion of objective falsity. Disputed question of legal interpretation can be a matter susceptible to an objective inquiry. Defendant either complied with the Stark Law or it didn t. This is an objective inquiry. 131

132 Cases and Decisions Discussed United States v. AseraCare Inc, No. 2:12-CV-245- KOB, 2015 WL (N.D. Ala. Nov. 3, 2015) United States v. AseraCare Inc, No. 2:12-CV-245- KOB, 2016 WL (N.D. Ala. Mar. 31, 2016) U.S. ex rel. Michaels v. Agape Senior Cmty., Inc., No. CA 0: JFA, 2015 WL (D.S.C. June 25, 2015), order corrected (July 6, 2015) Druding v. Care Alternatives, Inc., No. CV (JBS/AMD), 2016 WL (D.N.J. Feb. 22, 2016) 132

133 Cases and Decisions Discussed United States v. Southerncare, Inc., No. CV , 2015 WL (S.D. Ga. Sept. 9, 2015) Cretney-Tsosie v. Creekside Hospice II, LLC, No. 213CV00167APGPAL, 2016 WL (D. Nev. Mar. 30, 2016) United States ex rel. Fowler v. Evercare Hospice, Inc., No. 11-CV PAB-NYW, 2015 WL (D. Colo. Sept. 21, 2015). U.S. ex rel. Drakeford v. Tuomey, 792 F.3d 364, (4th Cir. 2015). 133

134 134 False Claims Act/Qui Tam Whistleblower Litigation Involving Health Care Providers Friday, May 6, 2016 False Claims Act Case Updates: Hospitals Mark Moore

135 QUI TAM ACTIONS AGAINST HOSPITALS False Claims Act CLE May 6, 2016 Mark C. Moore, Esquire Nexsen Pruet, LLC With thanks to Sherri Lydon, Esquire CLE PRESENTATION to SC Bar Members 135

136 ABBOTT NORTHWESTERN ET AL. In February 2016, fifty-one hospitals agreed to pay a total of $23 million to settle accusations they had billed Medicare for the implantation of Implantable Cardioverter Defibrillators (ICDs) during prohibited waiting periods. Patients are required to wait 40 days after a heart attack and 90 days after bypass/angioplasty to ensure that the ICD is still necessary. CLE PRESENTATION to SC Bar Members

137 ADVENTIST HEALTH SYSTEM In February 2016, Adventist agreed to pay $2 million to resolve claims that it had used left over chemotherapy drugs from previous patients. The single-dose vials do not include anti-microbial or other preservatives, potentially exposing later patients to harmful contaminants. Medicare was charged for a new vial for each patient. CLE PRESENTATION to SC Bar Members

138 DAVITA HEALTHCARE PARTNERS In June 2015, DaVita settled for $450 million in light of accusations it knowingly created waste that could have been minimized. The hospital billed the government for the avoidable waste it created during the administration of several drugs used in dialysis. The previous year, DaVita agreed to pay $350 million to settle claims of illegal kickbacks to referring physicians. CLE PRESENTATION to SC Bar Members

139 DIGNITY HEALTH In October 2014, Dignity Health agreed to pay $37 million to settle allegations that 13 of its hospitals had knowingly admitted Medicare and TRICARE patients who could have been treated more cost effectively through outpatient procedures. CLE PRESENTATION to SC Bar Members

140 STARK, KICKBACKS, & PHYSICIAN REFERRALS Citizens Medical (2015) $27.5 million Tenet Health Care (2016) $238 million Adventist Health (2015) $115 million North Broward Hospital District (2015) $69.5 million DaVita (2014) $350 million Columbus Regional (2015) $25 million Mercy Health & Clinic (2015) $5.5 million Tuomey Healthcare (2015) $237 million judgment $72.4 million settlement CLE PRESENTATION to SC Bar Members

141 BEST PRACTICES Be wary of consistent losses and referral tracking Scrutinize physician arrangements when losses are expected and document rationale for any such arrangement Anticipate increased individual liability for physicians and hospital boards Repay overpayments quickly, 60 day clock starts when put on notice of potential overpayment CLE PRESENTATION to SC Bar Members

142 THANK YOU Mark C. Moore, Esquire CLE PRESENTATION to SC Bar Members

143 143 False Claims Act/Qui Tam Whistleblower Litigation Involving Health Care Providers Friday, May 6, 2016 False Claims Act Case Updates: Laboratories Michael Gardener

144 144 Trends in False Claims Act Enforcement in the Laboratory Industry Michael S. Gardener, Mintz Levin May 2016 Mintz Levin. Not your standard practice.

145 Health Care Fraud Enforcement Climate 145

146 Background 1990s: LabScam, first systemic nationwide law enforcement project focused on the health care industry Early 2000s: The focus shifted to pharmaceutical companies and medical device companies Today: There is a renewed focus on laboratories again There seems to be a recent increase in prosecutions, settlements, and pending False Claims Act cases involving laboratories Laboratories are also facing lawsuits filed by insurance companies and competitors (which is not the subject of this presentation, but it is a notable trend) 146 3

147 Health Diagnostic Laboratory, Inc. (2015) HDL and Singulex settled three related whistleblower cases in March 2015 Together they agreed to pay $48.5 million ($47 million paid by HDL discounted amount based on ability to pay defense) Signed separate Corporate Integrity Agreements Cases brought by: A physician pitched by HDL A physician's office employee who provided billing services A physician's nursing supervisor The CEO of a competitor 147 4

148 Health Diagnostic Laboratory, Inc. (2015) Covered Conduct: Kickbacks - Offering and/or paying illegal remuneration to health care providers through ""process and handling' payments related to the collection of blood; speaker programs; advisory boards; consulting arrangements; goods and services; and gifts" in violation of the AKS and the Stark Law Co-pay waivers - Routinely offering to waive and/or waiving cost-sharing obligations, such as copayments and deductibles. for certain TRICARE beneficiaries, with the intent, to induce referrals, in violation of the AKS Medical necessity - Submitting or causing to be submitted claims for payment for tests that were not medically necessary Commission payments - Offering and/or paying illegal remuneration in the form of commission payments to BlueWave Healthcare Consultants, Inc. to induce BlueWave to arrange or recommend referrals, in violation of the AKS 148 5

149 Health Diagnostic Laboratory, Inc. (2015) According to the DOJ Press Release: "The claims settled by these agreements and asserted against these companies and individuals are allegations only, and there has been no determination of liability." DOJ intervened as to similar allegations and has filed its own complaint against: BlueWave Healthcare Consultants Inc. and its owners, Floyd Calhoun Dent and J. Bradley Johnson (independent sales group that worked on behalf of HDL and Singulex) HDL's former CEO, Latonya Mallory Berkeley HeartLab, Inc. ("BHL"), a now-defunct laboratory DOJ declined to pursue claims against Quest, BHL's parent company, and Singulex's former CEO 149 6

150 Health Diagnostic Laboratory, Inc. (2015) The government has also intervened as to BlueWave, the contract sales organization for HDL and Singulex HDL and BlueWave had a sales agreement HDL and Singulex purportedly paid BlueWave commissions that varied depending on the volume and value of referrals that BlueWave arranged for or referred to HDL and Singulex The government alleged that the commission payments were kickbacks 150 7

151 Millennium Laboratories (2015) Millennium Health (formerly Millennium Labs) is one of the country's largest urine drug testing laboratories The laboratory agreed to pay $256 million to resolve alleged violations of the False Claims Act The government alleged that Millennium: Billed Medicare, Medicaid and other federal health care programs for medically unnecessary urine drug and genetic testing Caused physicians to order excessive numbers of urine drug tests, in part through the promotion of custom profiles, which, instead of being customized for individual patients, were standing orders that resulted in physicians ordering large numbers of tests without individualized assessments of each patient s needs Provided free drug testing cups to physicians who agreed to refer laboratory testing business to Millennium 151 8

152 Biodiagnostics Laboratory Services ( ) This case has resulted in numerous convictions and indictments, including indictments of physicians who accepted kickbacks Over a 7-year period, BLS and related entities allegedly paid millions of dollars in kickbacks to physicians to induce referrals BLS reportedly received at least $200 million dollars from Medicare and private insurance payors for those referrals BLS allegedly paid physicians up to thousands of dollars a month through sham lease, service, consulting agreements Over at least 35 individuals (including BLS owners/employees as well as 26 physicians) have pled guilty; also a recent indictment Fines Forfeiture of cash received ($11.5 million recovered to date) Jail time or supervised release 152 9

153 Family Dermatology (2015) Settled a FCA case against the practice and its sole shareholder based on Stark Law, other violations for $3.2 million Allegedly purchased other practices and then contracted with selling dermatologists to work for the practice Required to send skin samples to the practice and the practice's lab Paid based on a percentage of professional services rendered by the physicians Suits filed by three physicians According to the DOJ press release: Health care companies that make sweetheart deals with physicians to boost profits undercut both the financial integrity of Medicare and the public s trust in the medical profession"

154 Ameritox v. Millennium Laboratories ( ) Enforcement by a private party rather than the government Ameritox brought suit against Millennium under Florida's unfair competition statute for violation of, among other laws, the federal Anti-Kickback Statute and the Stark Law Jury awarded Ameritox $ million and rejected all counterclaims Millennium appealed Government filed an amicus curiae brief supporting Ameritox U.S. Court of Appeals overturned the verdict on jurisdictional grounds

155 Michael S. Gardener, Mintz Levin Michael specializes in complex civil and criminal litigation and class actions, representing Fortune 100 corporations, health care companies, real estate developers and financial institutions in courts across the country. In addition to his full litigation practice, Michael also serves as General Counsel to the firm. Representative Matters Michael S. Gardener, Member Michael litigated one of the largest bankruptcy proceedings ever brought in the District of Massachusetts involving claims owed on International Place, the premier office tower in Boston. Michael s client was a secured creditor and is the largest office tower owner and developer in the United States. At the close of Michael s presentation of evidence in the trial, the debtor agreed to pay Michael s client $679 million, allowing the client to realize a return of more than double its cash investment in less than 10 months. See, In re Fort Hill Square Associates, United States Bankruptcy Court, District of Massachusetts, Docket Nos , Representing over 100 chain and independent pharmacies, following a bench trial, Michael obtained a judgment from the Massachusetts Business Court overturning the state s pharmacy assessment tax and ordering the Commonwealth to refund $18 million in taxes collected from the pharmacies. The court enjoined any further collection of the tax, resulting in a savings to Michael s clients of over $36 million annually. See, Allen s Pharmacy Cape Ann, et al. v. Ferguson, Massachusetts Business Court Civil Action No This case and another matter also handled by Mintz Levin lawyers were reported by Massachusetts Lawyers Weekly as the two largest trial verdicts awarded in Massachusetts in that year

156 Michael S. Gardener, Mintz Levin Representative Matters Continued Michael represented a Fortune 50 company under investigation by the federal government and 24 state attorneys general for alleged violations of the False Claims Act regarding drug pricing matters. Despite two years of grand jury proceedings, Michael persuaded the government agencies not to pursue any criminal charges and subsequently negotiated a favorable civil settlement. Michael was litigation counsel for the Indenture Trustee for the holders of over a quarter billion dollars of municipal bonds issued by Stockton, California in the second largest municipal bankruptcy case ever filed in the United States. In re City of Stockton, California, United States Bankruptcy Court, Eastern District of California, Case No Following over a week of trial, Michael won an arbitration award completely dismissing claims of material breach of a collaboration agreement that would have deprived Michael s client, an international biotech company, of its fifty percent interest in a billion dollar drug. Michael represented the CFO of a high-tech company for alleged unlawful backdating of stock options for hundreds of employees. Notwithstanding comments in the media by one of the nation s most respected securities law professors that the case presented the clearest instance of criminal scienter he had ever seen, Michael persuaded the federal government not to bring a criminal action against his client. Michael then negotiated a settlement with the SEC of all claims, without any admission of guilt by the client. Michael won a complete dismissal of a $360 million class action lawsuit alleging violations of RICO and the laws of over 25 states brought against one of the nation s leading laboratories. International Brotherhood of Teamsters Local 456 Health and Welfare Trust Fund v. Quest Diagnostics Incorporated, (E.D.N.Y. 2010) (Docket No. 10-CV-1692). Michael represented the CEO of a Fortune 50 company in a federal political corruption investigation. While other officers of the company were indicted (and subsequently acquitted), no charges were ever brought against Michael s client. After a six-week trial in the Federal Court of Claims in Washington, DC, Michael won a verdict for $8.8 million against the United States, the largest verdict for lost profits damages for a new venture ever awarded against the government. See, Energy Capital Partners v. United States, 47 Fed. Cl. 382, affirmed 302 F.2d Michael is representing a major oil company in connection with a multi-state investigation asserting violations of Underground Storage Tank Fund statutes and regulations. Following almost two weeks of hearings, Michael won an award of $10.2 million from a three-member arbitration panel in a manufacturing dispute. The panel denied all of the respondent's counterclaims and awarded Michael over two million dollars in attorney's fees. Michael persuaded even the other side's appointed arbitrator to join in the unanimous decision

157 Michael S. Gardener, Mintz Levin Representative Matters Continued Representing a multibillion-dollar grocery chain and its president, Michael won a verdict of dismissal following a trial in the US District Court in Massachusetts in a case alleging violations of ERISA by Michael s clients. See, Evanthea Demoulas v. Sullivan. In a first-of-its-kind privacy class action lawsuit brought in New York seeking $100 million in damages, Michael won a trial verdict dismissing all claims against his client, a Fortune 100 company. See, Anonymous v. Hinderstein, et al., (NY Sup. Ct. Index No /99). Michael was lead defense counsel on two other major privacy class action lawsuits where he obtained dismissal of all class actions claims. Representing the nation s largest hospital chain, Michael along with co-counsel successfully defeated an effort to enjoin the client s $33 billion leveraged buyout, the second largest LBO in American history. See, Foundation for Seacoast Health v. Hospital Corporation of America, N.H. Sup. Ct., Rockingham CO., Docket No. 06-E-583. Representing the nation s largest laboratory testing corporation and its board of directors, Michael won a complete dismissal of a shareholder derivative action seeking over $300 million in damages. See, Stern v. Baldwin, N.J. Chancery Court, Docket No. MRS-C Michael is representing a health care provider in an industry-wide investigation of certain billing practices by the Department of Justice. Michael won a judgment of dismissal at the close of plaintiff s evidence in the trial of an eight-figure accounting malpractice claim brought against a Big Five accounting firm. After being retained to represent one of the nation s largest health care providers that had received a criminal target letter from the US Attorney s Office, Michael was able to persuade the government to drop the case entirely against his client. Michael won a full dismissal of a $240 million derivative shareholders action brought against a major health care client. See Cornish v. Britell, N.J. Chancery Court, Docket No. MRS-C Michael represented a national telecommunications company in an appeal from a state agency ruling that threatened to prevent the sale of a major product. A week before trial, and following the filing of Michael s trial memo, the state Attorney General acknowledged it had no defense and consented to the entry of a declaratory judgment in favor of Michael s client. Michael successfully represented a leading laboratory in connection with a qui tam action filed in federal court in Ohio

158 Michael S. Gardener, Mintz Levin Representative Matters Continued Michael represented a multinational insurance company in a dispute litigated in the US District Court in Indiana. Plaintiff, another major insurance company, asserted that Michael s client had breached the terms of an acquisition by improperly underwriting over a billion dollars of placed insurance. Following nationwide discovery, the plaintiff settled for a small fraction of its claimed losses. Michael represented the plaintiff, a major real estate company, in the first and only case in the history of Massachusetts to succeed in overturning an eminent domain taking on the ground of municipal bad faith. See, Pheasant Ridge Ltd. Partnership v. Town of Burlington, 399 Mass. 771, 506 N.E. 2d Representing a business corporation against a national bank in a jury trial in the US District Court in Massachusetts, immediately following the commencement of Michael s cross-examination of the bank s chief witness, the bank quadrupled its settlement offer and the case resolved. Representing one of the largest cable companies in the United States, Michael succeeded in negotiating a favorable settlement of false advertising and unfair and deceptive business practices claims asserted by the Massachusetts Attorney General. Michael wrote the amicus brief in the Supreme Court on behalf of the Anti-Defamation League, the American Israel Public Affairs Committee and other prominent organizations in support of the appellant plaintiff in Zivotofsky v. Hillary Rodham Clinton. The Court vacated the judgment for the defendant and remanded for further proceedings. Following a trial in the US Immigration Court, Michael obtained an award of asylum for his pro bono client, a refugee from the Rwandan genocide. Michael represented a Ghana family pro bono in obtaining over $1.85 million from the September 11 Victims Compensation Fund. Michael served as counsel to one of the nation s largest private universities, advising on governance issues and a major restructuring of the board

159 159 False Claims Act/Qui Tam Whistleblower Litigation Involving Health Care Providers Friday, May 6, 2016 Whistleblower Retaliation Claims under Section 3730 (h) of the False Claims Act Joseph P. Griffith, Jr.

160 160 WHISTLEBLOWER RETALIATION CLAIMS UNDER 3730(h) of the FALSE CLAIMS ACT Joseph P. Griffith, Jr. Co-Chairman Joe Griffith Law Firm, LLC Qui Tam Section 7 State Street Federal Bar Association - SC Charleston, S.C T joe@joegriffith.com

161 INTRODUCTION Relator comes to you with claims of FCA fraud by her company Relator has complained or warned the company of the FCA frauds Company has taken one or more adverse actions against the Relator because of the complaints or warnings Harassed Demoted Suspended Terminated What are the client s rights and how do you advise the client? 161

162 U.S.C. 3730(h)-Relief from retaliatory actions. (2016 version) (1) Any employee, contractor, or agent shall be entitled to all relief necessary to make that employee, contractor, or agent whole, if that employee, contractor, or agent is discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against in the terms and conditions of employment because of lawful acts done by the employee, contractor, agent or associated others in furtherance of an action under this section or other efforts to stop 1 or more violations of this subchapter.

163 163 WHO CAN SUE: Employees Contractors / Sub-contractors Agents (Categories expanded from just employees in 2009)

164 164 WHAT CAN RELATOR SUE FOR UNDER 3730(h)(1): Retaliation or discrimination against the Relator in the terms and conditions of her employment Discharges (Actual or Constructive) Demotions Suspensions Threats Harassment, or Discrimination / Retaliation in any other manner

165 U.S.C. 3730(h)(2) Relief Available (2) Relief.--Relief under paragraph (1) shall include reinstatement with the same seniority status that employee, contractor, or agent would have had but for the discrimination, 2 times the amount of back pay, interest on the back pay, and compensation for any special damages sustained as a result of the discrimination, including litigation costs and reasonable attorneys fees.

166 166 STATUTE OF LIMITATIONS 3 YEARS 31 U.S.C. 3730(h)(3) Limitation on bringing civil action.--a civil action under this subsection may not be brought more than 3 years after the date when the retaliation occurred. NOTE: No longer look to comparable/analogous state law claims to determine statute of limitations

167 167 JURISDICTION U.S. DISTRICT COURT 31 U.S.C. 3730(h)(2) An action under this subsection may be brought in the appropriate district court of the United States for the relief provided in this subsection.

168 168 DECISION: FILE 3730(h) CLAIM UNDER SEAL or NOT UNDER SEAL Retaliation suit can be brought independently of an FCA suit Most retaliation claims are brought under seal along with FCA claims Allows the Government to conduct its investigation first If Government intervenes and settles FCA claims, most Defendants will not want to litigate the facts/fraud underlying FCA claims Provides discharged employees ability to seek employment without the publicity of having filed an FCA/Retaliation which can impair employability

169 169 ELEMENTS OF A 3730(h) CLAIM Plaintiff/Relator must prove that: (1) he engaged in protected activity by taking lawful action in furtherance of a qui tam suit or other efforts to stop 1 or more FCA violations; (2) his employer had notice of those acts; and (3) his employer took adverse action against him as a result of these acts. Mann v. Heckler & Koch Defense, Inc., 630 F.3d 338, 343 (4th Cir. 2010) Young v. CHS Middle East, LLC, 611 Fed.App x 130 (4th Cir. 2015)

170 WHAT IS 3730(h) PROTECTED ACTIVITY Investigations/Complaints/Warnings of frauds Elder v. DRS Technologies, Inc., 2013 WL , *6 (E.D.Va. Aug. 27, 2013). Verbally telling defendant of frauds - Young v. CHS Middle East, LLC, 611 Fed.App x 130 (4th Cir. 2015) Invoke concerns of fraud or make some suggestion of impropriety or illegality by the employer Scates v. Shenandoah Memorial Hospital, 2015 WL (W.D.Va.) Relator s conduct reasonably could lead to a viable FCA action, or when... litigation is a reasonable possibility. Mann v. Heckler & Koch Defense, Inc., 630 F.3d 338, 343 (4th Cir. 2010) (objective standard) [M]ust concern false or fraudulent claims, or it is not protected activity under the FCA. Glynn v. EDO Corp., 710 F.3d 209, 214 (4th Cir. 2013) Participation in FBI investigation of frauds - U.S. ex rel. Wuestenhoefer v. Jefferson, 105 F.Supp.3d 641 (N.D.Miss. 2015) 170

171 WHAT IS NOT 3730(h) PROTECTED ACTIVITY [S]imply reporting [a] concern of a mischarging to the government to his supervisor does not suffice to establish that a whistleblower plaintiff was engaging in protected activity. Lee v. Computer Sci. Corp., 2015 WL , at *6 (E.D.Va. Feb. 24, 2015) [M]ere refusal to participate in the fraudulent activity is not protected activity under the FCA. U.S. ex rel. Tran v. Computer Sciences Corporation, 53 F.Supp.3d 104 (D.C.D.C. 2014) 171

172 172 DEFENDANT S NOTICE/KNOWLEDGE REQUIREMENT the employer knew of the acts taken by the employee that constituted protected activity. the employer must have known that these acts raised a distinct possibility of a FCA suit. Huang v. University of Virginia, 896 F.Supp.2d 524, 551 (W.D.Va. 2012).

173 BURDEN SHIFTING PARADIGM UNDER 3730(h) Fourth Circuit has not yet ruled that McDonnell Douglas Title VII burden shifting applies, but many other Circuits have, and at least one district court in South Carolina has applied it Clinkscales v. Walgreen Co., 2012 WL (D.S.C.): 1. Plaintiff has to establish a prima facie case of discrimination/retaliation 2. Burden shift to Defendant to produce evidence of a legitimate, nondiscriminatory reason for the adverse action 3. Plaintiff must then demonstrate by a preponderance of the evidence that the proffered reason was not the true reason, but was a pretext for discrimination. Id. Prima Facie Case -- Plaintiff needs very little evidence of a causal connection to state prima facie case -- merely the closeness in time between the Protected Activity and the adverse action is sufficient. Id. Pretext can be shown by demonstrating Defendant s stated reason (1) is false or has no basis in fact, (2) was not the actual reason, (3) is insufficient to warrant the adverse action. Mikhaeil v. Walgreens Inc., 2015 WL (E.D. Mich.) Ultimate Question: Does Plaintiff s evidence produce a material dispute as to whether retaliation/discrimination occurred? Boone v. MountainMade Foundation, 64 F.Supp.3d 216, 232 (D.C.D.C. 2014) 173

174 MATERIALITY OF THE ADVERSE ACTION Employment decisions are only materially adverse if they are reasonably likely to deter employees from engaging in activity protected by the False Claims Act. U.S. ex rel. Howard v. Lockheed Martin Corp., 14 F.Supp.3d 982, 1021 (S.D.Ohio 2014) 3730(h) not intended to protect against trivial harms. Burlington N. and Santa Fe Ry. Co. v. White, 548 U.S. 53, 67 (2006). 3730(h) not intended to impose a general civility code for the American workplace. 174

175 MIXED MOTIVES CASES UNSETTLED STANDARD TWO TESTS ONE MOTIVATING FACTOR CAUSATION TEST Proper inquiry is whether the employer's adverse action against the employee [was] motivated, at least in part, by the employee's engaging in [that] protected activity ). United States ex rel. Schweizer v. Océ N.V., 677 F.3d 1228, 1237 (D.C.Cir.2012) BUT-FOR CAUSATION TEST Relators must show their protected conduct was a but-for cause of [their] discharge meaning that [Defendant] would [not] have [discharged them] in the absence of [the] proscribed motive. U.S. ex rel. Marshall v. Woodward, Inc., 85 F.Supp.3d 973 (N.D.Ill. 2015). 175

176 176 STANDARD OF PROOF The standard of proof a plaintiff must satisfy under Section 3730(h) is the normal civil one of preponderance of the evidence. United States ex rel. McKenzie v. Bellsouth Tel., 123 F.3d 935, 944 (11th Cir. 1996), cert. denied, 522 U.S (1998)

177 HARASSMENT RETALIATION CLAIMS SUPERVISOR HARASSMENT Must be severe or pervasive retaliatory harassment by a supervisor. Employer Affirmative Defense Employer (a) exercised reasonable care to prevent and correct promptly any... harassing behavior, and (b) plaintiff employee unreasonably failed to take advantage of any preventative or corrective opportunities provided by the employer to avoid harm otherwise. Morris v. Oldham Cty. Fiscal Ct., 201 F.3d 784, (6th Cir. 2000) CO-WORKER HARASSMENT (1) the co-worker s retaliatory conduct is sufficiently severe so as to dissuade a reasonable worker from making or supporting a charge of discrimination, (2) supervisors or members of management have actual or constructive knowledge of the co-worker s retaliatory behavior, and (3) supervisors or members of management have condoned, tolerated, or encouraged the acts of retaliation, or have responded to the plaintiff s complaints so inadequately that the response manifests indifference or unreasonableness under the circumstances. Hawkins v. Anheuser Busch, Inc., 517 F.3d 321, 346 (6th Cir. 2008) Only actionable if employer was negligent in failing to prevent the harassment from taking place. Vance v. Ball State Univ., 133 S.Ct. 2434, 2444 (2013). 177

178 DAMAGES UNDER 3730(h) All Relief Necessary to Make Relator Whole 3730(h)(1) 3730(h)(2) Elements of Damages: Reinstatement with the same seniority status that employee, contractor, or agent would have had but for the discrimination Front pay in lieu of reinstatement 2 times the amount of back pay Interest on the back pay Compensation for any special damages Litigation costs and reasonable attorneys fees 178

179 179 DAMAGES UNDER 3730(h) LOST PAY Lost Back Pay Damages Calculations are unsettled First Method - Double the back pay, then subtract earned/mitigated pay Neal v. Honeywell, 995 F.Supp. 889 (N.D.Ill 1998); U.S. ex rel. Mooney v. Americare, Inc., 2016 WL (E.D.N.Y.) Second Method Calculate back pay, subtract mitigated earnings, then double Wilkins v. St. Louis Housing Authority, 198 F.Supp.2d 1080 (E.D.Mo. 2001). Experts are needed must calculate Net Present Value of Loss Mitigation of Damages is an Affirmative Defense Molino v. Bast Services, Inc., 2011 WL (N.D.Ill.) (1) the plaintiff failed to exercise reasonable diligence to mitigate her damages; and, (2) there was a reasonable likelihood that the plaintiff might have found comparable work by exercising reasonable diligence.

180 DAMAGES UNDER 3730(h) EMOTIONAL DISTRESS Emotional Distress is a recoverable component of damages Neal v. Honeywell, 191 F.3d 827 (7 th Cir. 1999) - $200,000 in emotional distress damages upheld Townsend v. Bayer Corp., C.A.No. 5:11-cv-55-JMM, ECF # 107 (E.D.Ark. Nov. 2, 2012) - $568,000 emotional distress verdict Steffens v. Regus Group, C.A.No. 3:08-cv-1494, ECF # 144 (S.D.Cal. Mar. 22, 2013) - $850,000 emotional distress verdict; $3,500,000 punitive damages on wrongful discharge in violation of public policy Blakeslee v. Shaw Infrastructure, Inc., C.A.No. 3:09-cv-214-SLG, ECF # 364 (D.Ak. Mar. 20, 2013) - $486,458 emotional distress verdict; $3,500,000 punitive damages on wrongful discharge in violation of public policy 180

181 REGUS DAMAGES EMOTIONAL DISTRESS & PUNITIVES 181

182 BLAKESLEE DAMAGES - EMOTIONAL DISTRESS & PUNITIVES 182