Anti-Kickback Statute False Claims Act (FCA)

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The... more +
The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -
News & Analysis as of

Check Up on Healthcare Fraud Prosecutions

Chief compliance officers face an overwhelming level of risk in the healthcare sector. I do not mean to belittle the risks of corruption, AML, sanctions and other risks typically associated with global companies. Healthcare...more

Hospital/Physician Leases Compliance Checklist

LEGAL REQUIREMENTS: A "no" answer to any of the following questions may mean your lease is out of compliance with applicable laws. Is the lease in writing? Is the lease signed by both parties? Does it...more

Are Changes to the Stark Law on the Way?

Congress has acknowledged that the Stark law is standing in the way of the healthcare industry's transition to alternative, value-based payment models, and in turn, meaningful reform may soon be on the horizon. Last...more

Department of Justice Imposes Almost 100% Increase in Minimum and Maximum Monetary Penalties Under FCA

On June 30, 2016, the U.S. Department of Justice (“DOJ”) announced an interim final rule almost doubling per-claim penalties under the False Claims Act (“FCA”). The FCA still imposes treble damages for government losses in...more

Another Court Rejects Statistical Sampling and Rules That Difference of Opinion About Hospice Eligibility Is Insufficient for...

Back in March of this year, in U.S. ex rel. Paradies v. AseraCare, Inc., a district court in Alabama granted summary judgment to a defendant hospice finding that an expert physician’s disagreement with a certifying...more

Senate Finance Committee Examines Repeal of the Stark Law

A new report suggests that the Stark law is obsolete in new payment models. On June 30, the US Senate Committee on Finance (the Committee) released the report Why Stark, Why Now? Suggestions to Improve the Stark Law to...more

OIG Delivers Home Care a One – Two Punch: Release of Report and Alert on Home Health Fraud Highlights Increased OIG Scrutiny of...

On June 22, 2016, the Office of Inspector General (“OIG”) issued two communications that underscore its continued focus on fraud in home health care, along with the role of physicians as “gate keepers” in authorizing...more

Compliance Reminder — DOJ Announces Largest Healthcare Fraud Takedown

On Wednesday, June 22, 2016, the DOJ announced the largest nationwide heath care fraud takedown in history, which resulted in criminal and civil charges against 301 individuals for alleged participation in health care fraud...more

Court Rejects Qui Tam Attack on Standard On-Call Contract

On June 10 the Third Circuit affirmed a lower court’s dismissal of a physician’s qui tam action against Pottstown Memorial Medical Center (PMMC) for violating the Anti-Kickback Statute (AKS) and False Claims Act (FCA). And...more

Senate Finance Committee Updates Report on Physician-Owned Distributorships

The report finds that PODs increase overutilization, lack transparency, and increase the risk of patient harm and warns that hospitals must combat the growing threat of PODs. On May 10, the US Senate Committee on Finance...more

OIG Issues New Exclusion and CIA Guidance

On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more

Foreign Corrupt Practices Act Alert

Busy Q1 Yields Several Significant FCPA Resolutions - Overview - On February 19, during the US Securities and Exchange Commission’s (SEC) annual “SEC Speaks” conference, Kara Brockmeyer, Chief of the SEC’s FCPA...more

Compliance Lessons from the Olympus Corporate Integrity Agreement – Part I

The recent Olympus Corporation and related entities (collectively ‘Olympus’) enforcement action demonstrated a company seemingly dedicated to lying, cheating and stealing its way across the globe in search of almighty dollar....more

Anti-Kickback Enforcement – Steady and Aggressive

When commentators criticize the FCPA for its broad coverage of international business operations, these same commentators would have real trouble with the US Anti-Kickback statute. Talk about broad coverage and then...more

Olympus Settles FCPA Charges with DOJ

The Department of Justice resolved another FCPA investigation centered on payments made to health officials. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, Tokyo, Japan, and Olympus...more

CMS Finalizes Overpayment Reporting Rule, Intensifying Need for Proper Compliance Programs

The Centers for Medicare & Medicaid Services (CMS) published a Final Rule on February 12, 2016 requiring providers and suppliers receiving funds under the Medicare program to self-identify, report and return overpayments...more

Drug Manufacturer Discount Cards: Accept With Caution

Pharmaceutical manufacturer discount card usage by government program beneficiaries has been an active area for government action in recent years. In a September 2014 Special Advisory Bulletin, the U.S. Department of Health...more

Another Day, Another Whistleblower Retaliation Suit

A False Claims Act (“FCA”) retaliation claim, 31 U.S.C. 3730(h), filed January 26, 2016 in federal district court in Oregon, provides a perfect example of the type of challenging cases confronting health care employers today....more

DOJ Acknowledges in Proposed Jury Instructions That Dissemination of Truthful and Non-Misleading Off-Label Use Information Is Not...

For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...more

District Court Dismisses Government’s False Claims Act Complaint for Failure to Allege Actual False Claims with Particularity

On January 7, 2016 the United States District Court for the Middle District of Florida took the rare step of dismissing (with leave to amend) the government’s Complaint in Intervention in a False Claims Act Case. This case...more

Health Law Pulse - January 2016

CHANGES TO STARK LAW, NEW ADVANCE CARE PAYMENTS INCLUDED IN 2016 PHYSICIAN FEE SCHEDULE - The Centers for Medicare & Medicaid Services (CMS) recently published a final rule (Final Rule) regarding physician payment...more

Record Mega-Settlements May Attract More Whistleblowers

September was a record-setting month for the United States Department of Justice, which entered into major health care fraud settlements with two large Floridabased hospital systems. The settlements were made in the face of...more

Laboratories – 2015 Year in Review [VIDEO]

Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: December 2015

Trends & Analysis - We have identified 24 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of the 24 cases, five were filed within the past year, seven were filed in 2014, three...more

False Claims Act: 2015 Year in Review

This year continued the trend of aggressive False Claims Act (FCA) enforcement by the Department of Justice (DOJ) and high volumes of qui tam lawsuits brought by whistleblowers. In fiscal year 2015, the DOJ marked the fourth...more

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