Enforcement Perspective 2014 High Priority Areas
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1 Enforcement Perspective 2014 High Priority Areas CARMEN M. ORTIZ UNITED STATES ATTORNEY DISTRICT OF MASSACHUSETTS 1
2 IMPORTANCE OF HEALTH CARE FRAUD INVESTIGATIONS & PROSECUTIONS Expected 6.1% growth of health care spending in 2014* Implementation of ACA Projected to increase cumulative spending by $621 billion by 2022 Aging baby-boomer population End of federal government sequester Beneficiaries** Over 50 million enrolled in Medicare Over 62 million enrolled in Medicaid 2 *Source: Center for Medicare and Medicaid Services **Source: Department of Health & Human Services Office of Inspector General
3 HEALTH CARE FRAUD WHY A DOJ PRIORITY? ALLOCATION OF TAXPAYER DOLLARS TO FUND HEALTH CARE DRIVES UP COSTS FOR PATIENTS AND CONSUMERS THREATENS THE STRENGTH AND INTEGRITY OF SYSTEM ENDANGERS PATIENT SAFETY 3
4 BATTLING HEALTH CARE FRAUD DOJ Priority Consumer Protection Branch Civil & Criminal Frauds Division HCF Prevention and Enforcement Action Team (HEAT) Medicare Fraud Strike Forces U.S. Attorney s Office Priority Health Care Fraud Unit Affirmative Litigation Unit Special Focus Teams 4
5 THE COST OF NON-COMPLIANCE Nationally Prominent Cases GSK: $1 billion criminal fine, $2 billion resolution of civil liabilities (2012) J&J Misbranding: $2.2 billion (2013) Omnicare: $98 million (2009) Pfizer: $2.3 billion (2009) Abbott Laboratories: $1.5 billion (2012) FY2013 Collections* $3.2 billion collected from civil enforcement cases $450 million in criminal fines *Source: Department of Justice 5
6 NON-MONETARY COSTS Damage to reputation Effect on sales Consequences to consumer confidence Impact on business revenue 6
7 District of Massachusetts: Prominent Cases GlaxoSmithKline Pfizer Johnson & Johnson (Omnicare) Orthofix At Home VNA Glaxo Agrees to Pay $3 Billion in Fraud Settlement New York Times 7
8 VALUE OF WHISTLEBLOWERS Johnson & Johnson: $167.7 million GSK (Cidra): $96 million Abbott: $84 million Pfizer: $51.5 million 8
9 Johnson & Johnson $149 million settlement (2013) CONSEQUENCES OF KICKBACKS - OMNICARE IVAX Pharmaceuticals $14 million settlement (2009) Market-share rebates conditioned on active intervention program Below cost consultant pharmacist services Nursing Homes nationwide Omnicare $98 million settlement (2009) Leonard Grunstein Murray Forman Rubin Schron $8 million upfront payment conditioned on commitment to purchase $50 million in drugs $50 million for business with assets of only $3 million Mariner/Sava Health Care $14 million settlement (2010) 9
10 A TOP PRIORITY HOLDING INDIVIDUALS CRIMINALLY ACCOUNTABLE: ORTHOFIX Thomas Guerreri, former Vice President of Sales Paying kickbacks to prescribe Orthofix products Mitchell Salzman, former Regional Sales Director False declarations to a grand jury regarding Orthofix s conduct Derrick Field, former Territory Manager Falsifying patient medical records to induce Medicare to pay for bone growth stimulators Michael McKay, former Territory Manager Falsifying patient medical records to induce Medicare to pay for bone growth stimulators Michael Cobb, physician s assistant Accepting kickbacks in return for ordering Orthofix bone growth stimulators 10
11 CIAs: COMPENSATORY MEASURES Transparency and accountability: Clawbacks for executives Overhaul of compensation programs for sales representatives Certification of compliance by executives and board members Transparent research practices Strong monitoring and reporting provisions 11
12 Priorities Looking Ahead MANUFACTURING OF ADULTERATED DRUGS (COMPOUNDED DRUGS) DURABLE MEDICAL EQUIPMENT FRAUD HOME HEALTH CARE FRAUD (PHYSICAL, OCCUPATIONAL & SPEECH THERAPY) MEDICAL ID THEFT UNNECESSARY MEDICAL SERVICES FRAUDULENT MEDICAL RESEARCH 12
13 COMPLIANCE PROGRAMS: BEST PRACTICES Cooperate with government Willingness to self-report and take corrective action Executives making informed, clear and ethical decisions Clear chain of command Mandate ongoing training Establish ethical compensation plans for sales reps Conduct surprise site visits 13
14 Take-aways ENSURE EFFECTIVENESS OF LEGITIMATE COMPLIANCE PROGRAMS COOPERATE & CLEAN UP EXPANSION OF HEALTH CARE = EXPANSION OF OVERSIGHT 14
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