George Breen

George Breen

Epstein Becker Green

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Spotlight on Responsibility and Accountability: OIG’s New Compliance Guidance for Health Care Governing Boards

On April 20, 2015, the Office of the Inspector General of the U.S. Department of Health and Human Resources (“OIG”), in collaboration with the American Health Lawyers Association, the Association of Healthcare Internal...more

5/4/2015 - Board of Directors Chief Compliance Officers Corporate Governance Corporate Integrity Agreement Health Care Providers Healthcare Hospitals New Guidance OIG

CMS Issues Final Rule Designed to Enhance Agency Oversight of Medicare Providers and Strengthen Protections for Medicare...

On December 3, 2014, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule (CMS-6045-F) that updates various requirements for providers and suppliers wishing to enroll in the Medicare program. CMS issued...more

12/12/2014 - Affordable Care Act CMS Healthcare Providers Medicare

The False Claims Act and the Health Care Industry: 2014 Year in Review

On Nov. 20, 2014, the U.S. Department of Justice (“DOJ”) announced settlements and judgments for False Claims Act (“FCA”) cases totaling $5.7 billion (compared to $3.8 billion in fiscal year 2013), $2.3 billion of which was...more

12/12/2014 - Affordable Care Act Anti-Kickback Statute Anti-Retaliation Provisions DOJ False Claims Act Health Care Providers Overpayment Popular Retaliation Settlement Whistleblowers

HEAL Advisory: How Big Is Halbig? The Potential Effects of This Major Ruling Are Numerous and Significant

On July 22, 2014, the U.S. Court of Appeals for the D.C. Circuit and the U.S. Court of Appeals for the Fourth Circuit issued conflicting opinions on a key aspect of the Affordable Care Act ("ACA"). The cases are Halbig v....more

7/30/2014 - Affordable Care Act Appeals Barack Obama Employer Mandates En Banc Review Halbig v Burwell Health Insurance Health Insurance Exchanges Healthcare Reform King v Burwell SCOTUS Subsidiaries Tax Credits

DC Circuit Strongly Reaffirms the Applicability of the Attorney-Client Privilege to Internal Compliance Investigations

Especially in the District of Columbia Circuit, the home base for many fraud cases in which the government is opposed to health care providers and defense contractors, there had been considerable doubt that the...more

7/2/2014 - Attorney-Client Privilege Compliance False Claims Act Internal Investigations Kellogg Brown & Root Work-Product Doctrine

Supreme Court Declines to Opine on Circuit Split Over Rule 9(b) Pleading Requirements for FCA Claims

On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more

6/7/2014 - Certiorari Dismissals False Claims Act Healthcare Fraud Medicare Off-Label Use Pharmaceutical Pleading Standards Popular Qui Tam Rule 9(b) SCOTUS Split of Authority Takeda Pharmaceuticals Whistleblowers

New Proposed Rules Significantly Expand OIG's Exclusion Power

On May 9, 2014, the Office of Inspector General ("OIG") of the Department of Health and Human Services published in the Federal Register a proposed rule amending the regulations relating to OIG's exclusion authority...more

5/16/2014 - Affordable Care Act Civil Monetary Penalty Exclusions Healthcare HHS Medicare OIG Prescription Drugs

OIG's Special Advisory Bulletin on the Effect of Exclusion—Continuing the Focus on Individual Accountability

On May 8, 2013, the U.S. Department of Health and Human Services' Office of Inspector General ("OIG") released an Updated Special Advisory Bulletin on the Effect of Exclusion from the Participation in Federal Health Care...more

5/23/2013 - Civil Monetary Penalty Exclusions Healthcare OIG Self-Disclosure Requirements

OIG Unveils Updated Self-Disclosure Protocol

In 1998, the Department of Health and Human Services' Office of Inspector General ("OIG") published the Self-Disclosure Protocol ("SDP"), which provides a mechanism through which health care providers may voluntarily report...more

4/23/2013 - Anti-Kickback Statute Civil Monetary Penalty Disclosure Requirements Eligibility OIG Self-Disclosure Requirements Stark Law

HEALTH REFORM: OIG Issues Updated Guidelines for Evaluating State False Claims Acts: Is More State Litigation on the Horizon?

On March 15, 2013, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) released the Updated OIG Guidelines for Evaluating State False Claims Acts (“2013 Guidelines”), which replaces the...more

4/1/2013 - Affordable Care Act Civil Monetary Penalty False Claims Act FERA Healthcare Medicaid OIG Qui Tam

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