Microsoft Word - Final for LuLu Vol. 14 Issue 1 Final A. Development of the Responsible Corporate Officer Doctrine B. Who is Responsible Under the Responsible Corporate Officer Doctrine and Who Else Should be Held Responsible? C. Industries Most Affected by the Responsible Corporate Officer Doctrine D. Defenses to Responsible Corporate Officer Doctrine E. Civil Remedies of Exclusion 1. Exclusions of Individuals by the OIG 2. Exclusion of Entities by DOJ OxyContin Sales Personnel, Misbranding and Inadequate Compliance Program The Trio’s Defenses Others Involved in the OxyContine and the Illicit Drug Scandal The Trio’s Plea Deal Considering and Accepting the Trio’s Guilty Plea RCOD Resulting in Exclusion Does Not Violate Due Process Conflict of Interest and Indemnification http://doi.org/10.18060/3911.0032 OIG is focused on holding Responsible Corporate Officials accountable for healthcare fraud See United States v. Esformes et al. The Economic Case for Healthcare Reform HHS FY2015 Budget in Brief , The $272 billion swindle: Why thieves love America’s health-care system OIG Most Wanted Fugitives criminally per se or Id. The Responsible Corporate Officer Doctrine, A Re-emergent Threat to General Counsel and Corporate Officers Circumscribing the “Prosecutor’s Ticket to Tag the Elite”: A Critique of the Responsible Corporate Officer Doctrine A Bitter Pill for the Pharmaceutical Industry? HHS-OIG's Enforcement of the Responsible Corporate Officer Doctrine, Feds now target execs, not just companies, in health frauds supra supra misconduct . “ civil criminally even if Purdue Frederick Company More About the Responsible Corporate Officer Doctrine supra see also rev'd , History The Department of Health and Human Services and The Department of Justice Health Care Fraud and Abuse Program Annual Report for FY 2000 HHS Agencies and Offices About DOJ Improving Efforts to Combat Healthcare Fraud: Hearing Before the Comm. on Ways and Means, Subcomm. on Oversight Id. Id. Id. Id. supra HHS Historical Highlights supra Japanese and American Privacy Laws, Comparative Analysis supra see also Improving Efforts to Combat Healthcare Fraud: Hearing Before the Comm. on Ways and Means, Subcomm. on Oversight supra The Effect of Exclusion from Participation in Federal Health Care Programs supra supra Id Id Hospital Chain Will Pay over $513 Million for Defrauding the United States and Making Illegal Payments in Exchange for Patient Referrals; Two Subsidiaries Agree to Plead Guilty, A. Development of the Responsible Corporate Officer Doctrine Balint Balint Dotterweich. Dotterweich Dotterweich, Dotterweich United States v. Park. Park Rcra and the Responsible Corporate Officer Doctrine: Getting Tough on Corporate Offenders by Sidestepping the Mens Rea Requirement, see also Id. See Dotterweich supra Park becoming aware failed to correct Park without proof that the corporate official acted with intent or even negligence, and even if such corporate official did not have any actual knowledge of, or participation in, the specific offense See ee also ); ee also B. Who is Responsible Under the Responsible Corporate Officer Doctrine and Who Else Should be Held Responsible? RCOD prima facie mens rea Guidance for Implementing Permissive Exclusion , supra corporate C. Industries Most Affected by the Responsible Corporate Officer Doctrine not Ill. Hospital Chain Inks Record $5.5M HIPAA Deal, Florida Hospital System Agrees to Pay the Government $85 Million to Settle Allegations of Improper Financial Relationships with Referring Physicians, Community Health Systems Inc. to Pay $98.15 Million to Resolve False Claims Act Allegations, Data breach results in $4.8 million HIPAA settlements OCR Announces Initiative to More Widely Investigate Breaches Affecting Fewer than 500 Individuals, D. Defenses to Responsible Corporate Officer Doctrine qui tam qui tam qui tams civil criminal Halifax Top Ten Health Law Issues, Fraud and Abuse Enforcement, supra See Medicare Thief? Tenet Strikes Again: Serial Offender Offers $513M FCA Settlement Id. see also, Halifax not at the time quoting ., Id. Id. Id. See Practical Guidance for Health Care Governing Boards on Compliance Oversight Id. Corporate Integrity Agreements, E. Civil Remedies of Exclusion 1. Exclusions of Individuals by the OIG A Bitter Pill for the Pharmaceutical Industry? Hhs-Oig's Enforcement of the Responsible Corporate Officer Doctrine, The New OIG “Responsible Corporate Officer Doctrine”, supra Remarks at the American Bar Association’s 25th Annual National Institute on Healthcare Fraud U.S. v. Park Guidance for Implementing Permissive Exclusion supra supra Guidance for Implementing Permissive Exclusion supra Guidance for Implementing Permissive Exclusion supra Id. supra Id. Id. Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Healthcare Programs Purdue OxyContin ee infra Exclusions FAQ, Id. Id. Id. Id. supra 2. Exclusion of Entities by DOJ . . . . Id. , all stripes Purdue Purdue OxyContin Purdue’s Id supra rev'd Friedman vs. Sebelius: Purdue Executive Exclusion Upheld, but Terms Voided as Arbitrary and Capricious Purdue A. OxyContin Id. Id. Id. Id. rev’d Id. Id. Id. Purdue Says Kentucky Suit Over OxyContin Could Be Painful B. Sales Personnel, Misbranding and Inadequate Compliance Program supra Id. see supra Id. Id. C. The Trio’s Defenses D. Others Involved in the OxyContin and the Illicit Drug Scandal supra Id. supra supra Id. supra E. The Trio’s Plea Deal FedEx Faces Drug-Trafficking Charges, Cardinal Health Blocked from Shipping Painkiller in Florida Id. Id. Id. Id. Id. supra The Responsible Corporate Officer Doctrine: Defending Individuals in FDCA Cases F. Considering and Accepting the Trio’s Guilty Plea Id. see also supra supra See G. RCOD Resulting in Exclusion Does Not Violate Due Process See, e.g. id. See id. Exclusions FAQ supra Does an Exclusion Affect a Person’s Right to Receive Benefits Under the Medicare, Medicaid and all Federal Health Care Programs Id. H. Conflict of Interest and Indemnification will quid pro quo, Id. supra , Id. Id. Id. Id. supra see also Delaware Court Rules On Director's Entitlement To Indemnification For Expenses Incurred In Criminal Suit, Regulatory Action And Internal Investigation, Don't Win the Battle but Lose the War Retaining Directors' Mandatory Indemnification Rights in Settlements of Civil and Criminal Proceedings, Indemnification Clauses Id. e.g. Health Information and Data Security Safeguards see Physicians Post-PPACA: Not Going Bust At The Healthcare Buffet United States v. Park ., supra Id. supra knowing supra Compliance Guidance Id. Id Federal Fraud Enforcement and Physician Compliance, Id. A Guide to the Rulemaking Process DOJ’s Important Message to Health System Leadership Id. See Effective Compliance and Ethics Programs Under the Amended Sentencing Guidelines supra . supra quoting quoting Federal Fraud Enforcement and Physician Compliance, Compliance Program Policy and Guidance legal only if supra See supra