Addressing Government Investigations Marcos Daniel Jimenez Partner November 14, 2014
Agenda Statistics Key Players Fraud and Abuse Laws Potential Consequences Mitigation Strategies 2
Key Health Care Fraud Statistics Annual Health Care Fraud and Abuse Control Program Report by DOJ and HHS for FY13 $2.6 billion in health care fraud judgments and settlements (includes criminal fines, civil monetary penalties, asset forfeitures, penalties and multiple damages) $4.3 billion total recovery, up from $4.2 billion in FY12 $19.2 billion recovered in last five years $8.10 recovered for every dollar spent on investigations in last three years, highest ROR in program history 345 individuals charged criminally, with 234 guilty pleas and 46 jury trial convictions Average sentence 52 months in prison 1,013 new health care fraud criminal investigations opened 2,041 heath care fraud criminal investigations pending involving 3,535 potential defendants 3
False Claims Act Statistics - Recoveries FCA recoveries continue to be substantial Healthcare represents the majority of collections 4
False Claims Act Statistics - Lawsuits Most FCA cases are initiated by whistleblowers Source: DOJ "Fraud Statistics Overview" (December 23, 2013) 5
FCA Lawsuits: Notable Cases Johnson & Johnson: $2.2 billion settlement to resolve off-label marketing and kickback allegations. Settlement also included a corporate integrity agreement. Tuomey Healthcare System: $237 million verdict arising from Stark Law violations. Court trebled $39 million in damages and added $5,500 per false claim in civil penalties. Amedisys Home Health Companies: $150 million settlement arising from allegations of billing for ineligible patients and AKS and Stark Law violations. 6
Enforcement: Key Players Department of Justice (DOJ) United States Attorney s Offices (USAO) Federal Bureau of Investigations (FBI) Department of Health and Human Services (HHS) Office of Inspector General (HHS-OIG) Centers for Medicare and Medicaid Services (CMS) Food and Drug Administration (FDA) 7
Enforcement: Key Players Health Care Fraud Prevention & Enforcement Team (HEAT) Formed in May 2009 Collaboration between DOJ and HHS With its creation combating Medicare fraud became a Cabinet-level priority Has charged 1400 defendants who collectively false billed more than $4.8 billion, since inception Medicare Fraud Strike Force teams are key component Medicare Fraud Strike Forces Formed in March 2007 as part of a South Florida initiative to combat Medicare fraud among DME and HIV infusion therapy suppliers Has expanded to nine major cities Baton Rouge, Brooklyn, Chicago, Dallas, Detroit, Houston, LA, Miami, Tampa. State Regulators Attorney General Offices (consumer protection, privacy) 8
Fraud and Abuse Laws Anti-Kickback Physician Relationships Stark Corporate Practice of Medicine False Claims Act (false billing or retention) FDA regulations concerning labeling, promotion and advertising Quality of Care Data Privacy 9
Key Fraud and Abuse Laws Anti-Kickback Law (42 U.S.C. 1320a-7b(b)) Criminal statute that prohibits the exchange (or offer to exchange), of anything of value, in an effort to induce (or reward) the referral of federal health care program business (Medicare, Medicaid or other federal health care programs). In short, no payment for business. Sanctions felony conviction (imprisonment, fines), civil monetary penalties, exclusion from federal health care programs. Increasingly, enforcement actions arise from whistleblower (qui tam) actions under False Claims Act. 10
Key Fraud and Abuse Laws Stark Law False Claims Act (42 U.S.C. 1395nn) Prohibits Medicare payment for designated health services ( DHS ) services (e.g. hospital services, imaging, radiation) furnished pursuant to a prohibited referral. Referral prohibited if physician (or an immediate family member) has a financial relationship with the entity furnishing DHS, unless an exception applies. An entity furnishing DHS may not bill any party for DHS furnished pursuant to a prohibited referral. OIG pursues civil monetary penalties and administrative fines while DOJ prosecutes false claims act cases. Sanctions civil monetary penalties, potential exclusion. Unlike Anti-Kickback law, no wrongful intent necessary. 11
Key Fraud and Abuse Laws False Claims Act (32 U.S.C. 3729 et seq.) & Qui Tam Actions False or fraudulent claim presented to the U.S. Government (or retention of amount due, known as a reverse false claim) up to 80% of FCA cases are in the health care arena. Defendant must have knowledge of the falsity actual knowledge, deliberate ignorance or reckless disregard. False claims cases can even be brought against entities that don t themselves bill (e.g., pharmaceutical manufacturers) but cause the filing of a false claim by another. Penalties up to treble damages, plus $5500 to $11,000 per claim. 12
Key Fraud and Abuse Laws Federal Food, Drug and Cosmetic Act and FDA regulations concerning labeling, promotion and advertising Other Health Care Related (42 USC) and General Federal Criminal (18 USC) Laws e.g., Chicago prosecution of outpatient surgery center owner for honest services fraud and tax fraud for bribery scheme where owner paid cash to physicians in exchange for referring patients or conducting surgeries at the centers (not federal health care program business) State laws State False Claims Acts State law versions of the anti-kickback and self-referral laws 13
Potential Consequences Government Investigation/Prosecution Incarceration, Fines, CMPs, Forfeiture, Disgorgement Exclusion from Federal Programs Corporate Integrity Agreements Federal Monitor Private Litigation Whistleblower Lawsuits (False Claims Act) Class Actions Non-Litigation Disruption of Government Relationships Damage to Reputation Negative Publicity/Attack on Brand Impact on Transactions health care investigations typically span several years unless resolved early 14
DOJ Warnings On May 15, 2014, DOJ s assistant chief of criminal fraud announced that DOJ would ramp up efforts to charge corporations and executives rather than just individuals or small companies: if we find strong evidence of fraud, we have every intention of going after executives. 15
DOJ Warnings On September 17, 2014, Leslie Caldwell, the new Assistant Attorney General for the DOJ Criminal Division, announced that prosecutors are increasingly mining FCA lawsuits for evidence of criminal conduct by employees of health care companies and defense contractors. She urged attorneys to contact her division when filing qui tam complaints. [C]ases involving fraud by executives at health care providers, such as hospitals, are also a high priority for us. 16
Mitigation Strategies Proactive Strong compliance program HEAT has posted online Provider Compliance Training Videos (12 different topics) Reactive Prompt Internal Investigation Self-report If Necessary Smart Litigation Defense 17
Thank you 18