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The Trump Administration’s First 100 Days: Impact on the Health Care Industry – a Work in Progress

The first 100 days of a new presidential administration serves as a traditional, if somewhat arbitrary, demarcation point. April 29, 2017, serves as the 100th day of the Trump administration, and we now have insight into how...more

Supreme Court Rejects Government’s Expansive View of FCA Liability but Endorses Implied Certification Theory (with Limits)

On June 16, 2016, the Supreme Court of the United States rendered a unanimous decision in the highly anticipated False Claims Act (“FCA”) case of Universal Health Services, Inc. v. United States ex rel. Escobar.[1] In its...more

OIG Issues New Guidance on Its Evaluation Process and Non-Binding Criteria for Section 1128(b)(7) Exclusions

On April 18, 2016, the Office of Inspector General (“OIG”) of the Department of Health and Human Services issued a revised policy statement applicable to exclusions imposed under Section 1128(b)(7) of the Social Security Act...more

CMS Issues Long-Awaited Rule Regarding Reporting and Returning Overpayments

Section 6402(a) of the Affordable Care Act (“ACA”), which was enacted by Congress in 2010, requires a person who has received an overpayment to report and return the overpayment to the Secretary of Health and Human Services,...more

DOJ Focuses on Individual Accountability: New Guidance for Corporate Investigations Places Pressure on Companies and Boards to Put...

On September 9, 2015, the Department of Justice (“DOJ”) issued new guidance on individual accountability for corporate wrongdoing. In the memorandum and an accompanying speech by the Deputy Attorney General Sally Q. Yates,...more

The Clock’s Running Fast: SDNY Is First to Interpret “Identification” Under the FCA’s “60-Day Rule” for Government Overpayments

On August 3, 2015, in United States ex rel. Kane v. Healthfirst, Inc., et al., No. 1:11-cv-02325 (S.D.N.Y. Aug. 3, 2015), the United States District Court for the Southern District of New York issued the first reported...more

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

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

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

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

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

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

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

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

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

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

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