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DOJ Issues New Guidance on the Evaluation of Corporate Compliance Programs in Federal Fraud Investigations

On February 8th, the U.S. Department of Justice (DOJ) quietly issued new guidance on how the agency evaluates corporate compliance programs during fraud investigations. The guidance, published on the agency’s website as the...more

Workplace Law Regs On White House Chopping Block

Last week, President Trump signed an executive order requiring every federal agency to establish a “Regulatory Reform Task Force” to eliminate what he considers to be unnecessary and burdensome regulations hampering the...more

You’re Fired: What Impact Will Sally Yates’ Departure Have on the DOJ’s Fraud Enforcement?

As most of the world now knows, President Trump fired acting Attorney General Sally Yates last week after she declined to defend the President’s travel ban. Dana Boente has replaced Ms. Yates, but he may not be long for the...more

False Claims Act: 2016 Year-in-Review

In 2016, the Department of Justice (DOJ) continued to give high priority to False Claims Act (FCA) investigations and prosecutions. The government brought in more than $4.76 billion in settlements and judgments, nearly a...more

Overcoming the obstacles and realizing the benefits of a chapter 11 healthcare restructuring

Many healthcare businesses, both for-profit and not-for-profit, have faced financial distress. Among the factors that may contribute are lower reimbursement rates, changes in the delivery of services, regulatory shifts, and...more

DOJ False Claims Act recoveries – implications for the health industry

The US Department of Justice Civil Division released its False Claims Act (FCA) recovery statistics for Fiscal Year 2016 on December 13, 2016, announcing that it had recovered $4.76 billion. This represents an increase of...more

U.S. Department of Justice Recovered More Than $4.7 Billion From Civil False Claims Act Cases in 2016

On December 14, 2016 the United States Department of Justice made its annual announcement of the amount of money recovered in civil False Claims Act settlements and judgments in Fiscal Year 2016. ...more

The Federal Government Holds Individuals Responsible for Involvement in Corporate Healthcare Fraud and Abuse

In September 2016, three corporate officers in two healthcare fraud and abuse cases settled allegations that they were personally liable for violations of federal fraud and abuse laws. These settlements come one year after...more

Recent Settlements Demonstrate the Reach and Versatility of the FCA

In recent years, civil enforcement efforts involving the FCA have grown significantly. Today, the FCA impacts a vast array of businesses, as it is commonly used to redress false claims for government funds involving...more

Former CEO of Health System Agrees to Pay $1 Million to Settle False Claims Act Case with U.S. Department of Justice

In the most recent example of its continued effort to hold individuals accountable for corporate misconduct, the U.S. Department of Justice (“DOJ”) announced on September 27, 2016, that the former CEO of Tuomey Healthcare...more

Corridors - October 2016 - News for North Carolina Hospitals

Proposed 2017 Hospital OPPS Rule Would End Medicare Payments to Many Off-Campus Facilities at the Same Levels as Hospital-Based Outpatient Departments - Published on July 14, 2016, CMS’s proposed 2017 Hospital...more

Ninth Circuit: Manipulation of Risk Adjustment Data Subjects Insurers to False Claims Act Liability

The U.S. Court of Appeals for the Ninth Circuit has revived a whistleblower suit against Aetna, UnitedHealthcare and WellPoint for allegedly submitting false data for Medicare Advantage payments. Some of the nation’s largest...more

Preparing for an Exit: Selling Your Robotics Company

Robots are everywhere. Healthcare, logistics, manufacturing and other critical areas of the economy are being redefined by the robotics and artificial intelligence advances of today’s technology entrepreneurs. With this...more

AGG Food and Drug Newsletter - June 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Ninth Circuit Denies Medicare Payments in Assets-Only Purchase Without Assignment of Provider Agreement

On April 11, 2016, the Ninth Circuit Court of Appeals ruled that a hospital was not entitled to Medicare payments in an assets-only purchase until the Buyer enrolled in the Medicare program because it did not accept the...more

Assess and enhance your compliance program in this time of elevated risks

Continuous changes in the healthcare industry are delivering exciting innovations and new opportunities, but they are also creating new threats. Healthcare organizations face changing operational and enforcement environments...more

Are Compliance Officers the New Enforcement Targets?

For years health care compliance officers have worried about personal liability for the misdeeds of the companies they serve. And why not? Health care is the most heavily regulated of all major industries, and the compliance...more

Principal Deputy Assistant Attorney General Mizer on Yates Memo: “No Partial Credit for Cooperation that Doesn’t Include...

Principal Deputy Assistant Attorney General Benjamin C. Mizer’s remarks at the 16th Pharmaceutical Compliance Congress and Best Practices Forum highlighted the Department of Justice’s “renewed commitment to ensuring that...more

Changing Basic Rules of the Game: CMS Proposed Rule Relating to ACO Governance and Contracting

The Centers for Medicare and Medicaid Services released a new proposed rule for Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP). This advisory expands upon our initial...more

HHS-OIG Corporate Integrity Agreements Are Now Aiming at Corporate Directors and Executives

Corporate integrity agreements (CIAs) are a familiar feature of many civil False Claim Act and joint civil/criminal resolutions in healthcare fraud cases. These agreements are entered into between the defendant company and...more

Sending the Privilege Away: Attorney-Client E-Mails in the Corporate Setting

In a pending False Claims Act (“FCA”) case involving allegations of noncompliance with the federal physician self-referral law (the “Stark Law”), 42 U.S.C. § 1395nn, the United States District Court for the Middle District of...more

Navigating the Provider Self-Disclosure Protocol

Providers can voluntarily disclose potential fraud with respect to Federal health care programs — Medicare, Medicaid, and potentially private insurers to the extent Federal or state funds are involved — by following the...more

Mandatory Compliance Programs for Healthcare Companies

The healthcare industry always has taken the lead in compliance issues, developing innovative compliance tools and programs. Anti-corruption compliance borrows heavily from many healthcare compliance ideas....more

False Claims Act Compliance and Health Care

Doctors and health care service providers are under the False Claims Act microscope. The risks are significant and the costs can be astronomical. For all the obvious risks, doctors, hospitals, PPOs, HMOs, and health care...more

"Violations of Corporate Integrity Agreement Trigger Divestiture Action by HHS OIG"

In a little-noticed decision, the Office of the Inspector General of the Department of Health and Human Services (OIG) has forced a company that violated its corporate integrity agreement (CIA) to divest a subsidiary as a...more

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