Anti-Kickback Statute False Claims Act

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

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

HHS to Audit Hospital Reporting of GPO Payments: GAO Report Suggests Further Scrutiny of GPO Shareback with Hospitals

On November 24, 2014, the Government Accountability Office (“GAO”) published a report examining the contracting practices and funding structures of health care group purchasing organizations (“GPOs”) and their potential...more

"U.S. v. Novartis: Reaffirming the Importance of Updating and Adhering to Corporate Policies"

A recent decision in a false claims act case, United States ex rel. Bilotta v. Novartis Pharmaceuticals Corporation (Novartis), underscores the importance of policing employee adherence to corporate policies and industry...more

Uncertain Privilege: Implied Waiver of the Attorney-Client Privilege in False Claims Act Litigation

In a pending False Claims Act (“FCA”) case stemming from alleged violations of the physician self-referral law (the “Stark Law”), 42 U.S.C. § 1395nn, and the federal Anti-Kickback Statute (“AKS”), 42 U.S.C. §1320a-7b, the...more

Pharmaceutical manufacturers beware: HHS OIG issues warning about copay coupon programs

The Office of Inspector General of the Department of Health and Human Services recently issued a warning to pharmaceutical manufacturers, reminding them that copay coupons used for drugs purchased through federal healthcare...more

Words can come back to haunt you: Boilerplate pleading could lead to inadvertent waiver of attorney-client privilege

Recently, a federal district court in Georgia ruled that a defendant waived the attorney-client privilege in communications with counsel about the lawfulness of its conduct under the False Claims Act simply by pleading good...more

Provider Waives Attorney-Client Privilege in Qui Tam Case by Asserting Compliance with Law

A federal district court recently rejected a health care provider’s claim of attorney-client privilege and ordered the provider to produce written communications with its lawyers regarding the provider’s compliance with the...more

Whistleblower Goes It Alone to Secure $5 Million Settlement under False Claims Act

The potential success of a whistleblower lawsuit filed under the False Claims Act (FCA) is significantly reduced when the government fails to intervene because such cases are often assumed to lack merit. However, a plaintiff...more

Department of Justice Files First False Claims Act Lawsuit Against Physician-Owned Distributorship

On Sept. 8, 2014, the United States Department of Justice (DOJ) filed a 98-page civil complaint alleging that investment returns, paid to a Michigan spinal surgeon and other physicians by a spinal implant company partially...more

OIG Issues Special Advisory Bulletin on Pharmaceutical Manufacturer Copayment Coupons

On September 19, 2014, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a Special Advisory Bulletin on Pharmaceutical Manufacturer Coupons (the “Advisory Bulletin”) warning pharmaceutical...more

OIG Warns Pharma Its Copayment Coupons May Aid Crime

Brand name drugs cost a lot. So to make them more attractive, drug manufacturers issue coupons for discounts on the copayment portion of the price. They work the same as the dollar-off coupons offered by cereal manufacturers....more

OIG Issues Special Advisory Bulletin Covering Manufacturer Copay Coupons and Medicare Part D

For years, many drug manufacturers have issued coupons to help cover some or all of the cost of copayments (commonly referred to as a “copay”) for prescription medications. While the Department of Health and Human Services...more

Independent Hospitals Innovating, Finding New Partnerships in Response to Market Pressures

Standard & Poor’s (S&P) Rating Services recently warned the health care sector was at “a tipping point where negative forces have started to outweigh many providers’ ability to implement sufficient countermeasures.” S&P noted...more

HealthCare Fraud and Courtesies: What to Know Before Waiving a Copayment

Many healthcare facilities and physicians waive the insurance copayment for physicians and their families (known as professional courtesy) or other patients. Yet, despite how prevalent the practice is and the limited...more

Another Court Weighs in on Rule 9(b)’s Requirements Under the False Claims Act

A federal district court recently dismissed a qui tam relator’s complaint in a declined case against the Hospital for Special Surgery (“Hospital”), its former CEO, and an outside billing company alleging that they violated...more

Summer Fraud and Abuse Roundup

The federal government was busy over the summer when it came to decisions and settlements under the Stark Law, anti-kickback law and federal False Claims Act. This article revisits recent developments with respect to...more

Whistleblower Receives More Than $17 Million in Omnicare Case

A decision has been made in the case against Omnicare, Inc. that will net a former Omnicare pharmacist more than $17.2 million in the ensuing settlement. The settlement with the Department of Justice orders Omnicare,...more

What’s Scarier than a Compliance Officer Turned Whistleblower? A Whole Association of Them

In U.S. ex rel. Corporate Compliance Assocs. v. N.Y. Society for the Relief of the Ruptured & Crippled the court ruled that the whistleblower failed to meet the False Claims Act’s requirement that allegations be described...more

Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

Drug Distributor and Pharmacies Obtain Partial Dismissal of State and Federal FCA Claims

On June 10, 2014, a New York federal court dismissed, in part, state and federal False Claims Act (FCA) claims brought against Novartis Pharmaceuticals Corporation and pharmacies to which it distributed (CVS Caremark Corp.,...more

Commission-Based Sales Agreements for Medical Supplies and Equipment: More Whistleblower Activity on the Horizon? - A Wide Range...

The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more

Healthcare Law: What Every Provider Should Know

Healthcare is an incredibly broad, diverse and dynamic industry. Because of the breadth in the field, providers are surrounded by a wide array of legal issues relating to: employment contracts, taxes, business structure,...more

Pricing Issues Affecting Laboratories

Craig Holden co-presented "New Compliance Red Flags Workshop," a workshop hosted by G2 Intelligence. Over the past five years, the Departments of Justice and Health and Human Services have recovered $19.2 billion from...more

Recent Settlements Underline the Antikickback Statute's Central Role in Health Care Enforcement

In recent years, the antikickback statute (AKS) has emerged as an essential legal weapon to combat alleged misconduct in the health care industry. The government’s enforcement patterns reflect how the AKS is increasingly used...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act (FCA) Cases

Trends & Analysis: •We have identified 23 health care–related qui tam cases unsealed since last month’s Qui Tam Update. Only six of those cases were filed in 2013. The majority (13 cases) were filed in 2011 or 2012,...more

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