Trends in Health Care Enforcement: Past, Present, and Future July 21, 2014 3:30-4:45 Eastern This webinar is sponsored by the Fraud and Abuse Practice Group. Faculty : Susan Winkler Assistant U.S. Attorney, U.S. Attorney s Office, Boston, MA Susan.Winkler@usdoj.gov Laura Laemmle-Weidenfeld Jones Day, Washington, DC lweidenfeld@jonesday.com 1
Early Stages of Health Care Fraud Enforcement False Claims Act Amendments of 1986 Health Insurance Portability and Accountability Act (HIPAA), 1996 Expansion of enforcement resources in USAOs, Main DOJ, FBI, HHS-OIG Health care fraud focus in Boston USAO, other key USAOs Coordination between USAOs, Main DOJ Internal structure for health care fraud team in Boston USAO, contrasted with other USAOs Development of caselaw under which violations of Antikickback Statute and other laws could trigger FCA liability Expansion into pharmaceuticals, medical devices 2
HCFAC Report for FY 1997 $1.087 billion collected in criminal fines, civil judgments/settlements, and administrative sanctions $968 million returned to Medicare Trust Fund $31 million recovered as federal share of Medicaid More than 2700 individuals and entities excluded (93% increase over 1996) 4,010 civil health care matters opened (61% increase over 1996) 3
HCFAC Report for FY 2013 $4.3 billion collected from health care fraud matters $2.85 billion went to Medicare Trust Funds Over $576 million recovered as federal share of Medicaid HCFAC has returned over $25.9 billion to Medicare Trust Funds since inception in 1997 FY 2013, DOJ opened 1,013 new criminal health care fraud investigations involving 1,910 potential defendants. FY 2013, DOJ opened 1,083 new civil health care fraud investigations FY 2013, HHS-OIG investigations resulted in 849 criminal actions, 458 civil actions, and 3,214 exclusions 4
Selected USAO Boston Recoveries 2000-2012 Year Case Criminal Civil 2000 National Medical dialysis 102 million 384 million 2001 TAP Pharmaceuticals free samples 290 million 596 million 2003 Bayer Corporation lick and stick 5.59 million 257 million 2004 Warner Lambert off label 190 million 240 million 2005 Serono Laboratories kickbacks and fraud in sales 136 million 567 million 2006 Schering Plough kickbacks/off-label 180 million 255 million 2007 Pharmacia kickbacks 19 million 2009 Pfizer off label, kickbacks 1.3 billion 1 billion 2010 GSK Cidra cgmp 150 million 600 million 2011 Forest Laboratories off label/ kickbacks/obstruction 164 million 149 million 2012 Merck off label/safety 321 million 628 million 2012 GSK off label/safety 1 billion 2 billion
Recent Trends in Health Care Fraud Enforcement Impact of FCA revisions via FERA/ACA Focus on individuals as targets (civilly and criminally) Parallel investigations Increase in qui tams Strike Force/HEAT Pharma and device cases Use of FCA and criminal enforcement to pursue regulatory violations Attorney-client privilege sensitivities Use of DPAs, monitorships Activity by state Ags FCPA 6
FY 2013 FCA Enforcement Statistics 752 new qui tam matters filed Total federal health care recoveries under the FCA exceeded $2.5 billion $1.8 billion from alleged false claims for drugs and medical devices reimbursed under Federal health care programs Additional $443 million for state Medicaid programs Total reward paid to qui tam relators in health care cases was $345 million 7
Future Issues in Health Care Fraud Enforcement Impact of Affordable Care Act Medicaid expansion HIPAA Other? 8
Trends in Health Care Enforcement: Past, Present, and Future 2014 is published by the American Health Lawyers Association. All rights reserved. No part of this publication may be reproduced in any form except by prior written permission from the publisher. Printed in the United States of America. Any views or advice offered in this publication are those of its authors and should not be construed as the position of the American Health Lawyers Association. This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is provided with the understanding that the publisher is not engaged in rendering legal or other professional services. If legal advice or other expert assistance is required, the services of a competent professional person should be sought from a declaration of the American Bar Association 9