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

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,

Fedsnow 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

suprasee 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.

supraHHS 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

supraThe Effect of Exclusion from Participation in Federal Health Care Programs

supra

supraIdIdHospital 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

BalintBalint

Dotterweich. Dotterweich

Dotterweich,

DotterweichUnited

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 awarefailed 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 eealso ); ee also

B. Who is Responsible Under the Responsible Corporate Officer Doctrine and Who Else Should be Held Responsible?

RCOD

prima facie

mens rea

Guidancefor 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 tamqui 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 suprasupra

Guidance for Implementing Permissive Exclusion supra

Guidance for Implementing Permissive Exclusion supraId.

supraId.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

supraId.

supra

supraId.

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

supraSee

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.

suprasee 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.,

supraId.

supra

knowing

supraCompliance Guidance

Id.IdFederal 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 quotingquoting

Federal Fraud Enforcement and Physician Compliance,

Compliance Program Policy and Guidance

legal

only if

supraSee supra