News & Analysis as of

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 -

Debtor’s Subchapter S Status Isn’t Property of the Estate

This post examines an interesting intersection between bankruptcy and tax laws: if a corporation terminates its Subchapter S status pre-bankruptcy, can a bankruptcy trustee bring fraudulent transfer claims against the...more

Health Care Fraud Institute Held at Georgia Bar Headquarters

by Arnall Golden Gregory LLP on

On December 7, 2017, the Institute for Continuing Legal Education (ICLE) of the State Bar of Georgia held its annual Health Care Fraud Institute. Topics discussed at the Institute included recent federal and state fraud and...more

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

Health Update - November 2017

Fraud and Abuse 2017: Understanding Trends and Avoiding Actions - Editor’s Note: In a recent webinar for Bloomberg BNA, Manatt examined game-changing fraud and abuse trends and cases—and revealed strategies for avoiding...more

Recent Case Highlights Risks of Paying Physicians for Routine Duties - Signed writing required, informal documentation may not be...

by Stinson Leonard Street on

Payments to physicians, even for routine, necessary duties, may cause referrals to the entity making the payments to be "prohibited referrals" under the Stark Law. This means the hospital or other entity should not have...more

“Always a bridesmaid, never a bride” Might Work for Stark Liability but Not the Anti-Kickback Statute

by Nossaman LLP on

Last Thursday, a jury in federal district court in St. Louis handed down a verdict in a False Claims Act (“FCA”) case that presents a laundry list of the challenges which can arise in a FCA case. ...more

Kickback Arrangements – Cause for Alarm Beyond Federal Healthcare Programs

by Farrell Fritz, P.C. on

Few, if any, in the medical industry are unfamiliar with the federal Anti-Kickback Statute (“AKS”). Under AKS, those giving or receiving compensation for referrals for items or services reimbursed by the federal healthcare...more

Physicians in the Bulls-eye

by BakerHostetler on

Several recently reported cases highlight the growing risk physicians face if they succumb to competitive pressures, especially offers of remuneration from labs, pharmacies, home health agencies and other providers to whom...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: September 2017

by Mintz Levin on

In this month’s issue of our Qui Tam Update, we review an unusual cluster of five cases alleging that common defendants — a health care provider and its subsidiaries — provided medically unnecessary services to hospice,...more

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

by Pepper Hamilton LLP on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

A Path Forward: Corporate Integrity Agreement Sheds Light on Manufacturer Interactions With Independent Charitable Foundations

by Hogan Lovells on

Manufacturers of pharmaceuticals and biologics have been closely watching the industry-wide investigation by the Boston U.S. Attorney's Office into manufacturer support of independent charitable foundations that assist...more

Aegerion Settles Criminal and Civil Probe of Promotional Practices, REMS and HIPAA Compliance, and Patient Assistance Programs

On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a lipid-lowering agent for the...more

Six Home Health Providers Agree to Pay $1.8 Million to Settle False Claims Act Liability

by King & Spalding on

On September 5, 2017, the Department of Justice (DOJ) announced that six Tennessee-based home health entities agreed to pay the United States $1.8 million to settle potential violations of the Stark Law and/or Anti-Kickback...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

Second Circuit Accepts Appeal of False Claims Act First-To-File Issues

by Farrell Fritz, P.C. on

The Second Circuit recently agreed to accept an interlocutory appeal to decide the question whether a violation of the False Claims Act’s “first-to-file” rule compels dismissal of the complaint or whether it can be cured by...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: August 2017

by Mintz Levin on

In this issue we report on recent qui tam activity and look at three unsealed cases. One case involves allegations of “up coding” by a hospital that allegedly billed routine transport as emergency transport, reimbursed at...more

Avoiding Risks with Referring Physician Compensation Arrangements

by Hinshaw & Culbertson LLP on

The settlement described below highlights the importance of carefully structuring compensation arrangements with referring physicians, and the risk involved in trying to work backwards to achieve a desired level of...more

Court Puts the Brakes on Whistleblower's FCA Parking Claims

by Baker Ober Health Law on

The Department of Justice (DOJ) reports that, in fiscal year 2016 ending September 30, it obtained more than $4.7 billion in settlements and judgments from civil cases involving fraud and false claims. More than half of this...more

EHR Vendors Beware: eClinicalWorks Settles with DOJ for $155 Million

by Dorsey & Whitney LLP on

The Department of Justice (“DOJ”) announced on May 31, 2017, a $155 million settlement of its lawsuit alleging False Claims Act (“FCA”) and Anti-Kickback Statute (“AKS”) violations committed by eClinicalWorks (“eCW”), one of...more

Healthcare Law Update: June 2017

by Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

Proceed with Caution in Using New Process to Self-Report Stark Law Violations

by Barley Snyder on

Effective June 1, health care providers must use standardized forms for reporting Stark Law violations to the Centers for Medicare & Medicaid Services (CMS). These forms are part of a self-referral disclosure protocol (SRDP)...more

FCA Issues to Watch: Intersection of the FCA and the Anti-Kickback Statute

by Bass, Berry & Sims PLC on

In the recent past, the government has racked up a number of FCA settlements based on alleged violations of the Anti-Kickback Statute (AKS). This focus undoubtedly will remain a high enforcement priority....more

FCA Issues to Watch: Pharmaceutical and Device Developments | INSIDE THE FCA

by Bass, Berry & Sims PLC on

The government’s FCA enforcement efforts have continued to focus on key areas concerning the pharmaceutical and medical device industries. In fact, drug and device manufacturers accounted for nearly half of the enforcement...more

Health System Defeats FCA Suit Based on Alleged Provision of Free Parking Benefits and Tax Exemptions

by King & Spalding on

On April 18, 2017, the United States District Court for the Middle District of Florida adopted the magistrate judge’s report and recommendation and granted BayCare Health System’s (BayCare’s) motion for summary judgment. The...more

District Court Rules Online Auction for Medical Supplies Violates Anti-Kickback Statute

by Jones Day on

On March 6, 2017, the U.S. District Court for the District of Connecticut held that an arrangement between a company operating an online portal for purchases of medical equipment and a supplier of medical products violates...more

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