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Reporting Deadline for HIPAA Breaches – March 1, 2015 – Did you have a HIPAA breach this year involving less than 500 individuals? If so, the deadline to report such a breach to the U.S. Department of Health and Human...more

DOJ Settles False Claims Act Allegations Against Pharmaceutical Manufacturer

On February 11, the DOJ announced a $7.9 million settlement with a Delaware-based pharmaceutical manufacturer for allegedly violating the False Claims Act by engaging in a kickback scheme with a pharmacy benefits manager...more

Device Manufacturer Settles False Claims Act Allegations with DOJ for $1.25 Million

The Department of Justice (DOJ) recently announced that ev3 Inc. (which acquired Fox Hollow Technologies, Inc. (“Fox Hollow”), a medical device manufacturer, in late 2007) agreed to pay $1.25 million to resolve allegations...more

Sixth Circuit Examines Materiality and Government Knowledge under the FCA

As its name implies, the False Claims Act (FCA) prohibits false or fraudulent claims to the federal government. Broadly construed, the FCA can apply to anyone receiving federal funds, but it is especially critical to...more

Anti-Kickback and Stark Law: Pitfalls and Problems

When you think your life is tough in the FCPA compliance arena, just remember you could be head of compliance for a pharmaceutical company or hospital responsible for domestic anti-kickback and Stark law compliance....more

Medicare DMEPOS Competitive Bidding Window is Now Open

The bidding window is now open for the Medicare Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program Round 2 Recompete and the National Mail-Order Recompete for diabetic testing...more

Ethics in Pharmaceutical Sales: Strengthening Corporate Culture and Preventing False Claims Act Violations

“I didn’t set out to commit a crime. I certainly didn’t set out to hurt anyone… I was kind of a hero, because I helped the company make its numbers every quarter. And I thought I was doing a good thing. I thought I was...more

2014 – The Health Law Year in Review

Each year brings significant changes and challenges in the laws governing the health care industry, and 2014 proved to be no exception. What the year may have lacked in the high drama that accompanies comprehensive health...more

Federal Judge Awards Attorneys’ Fees to Defendant in Dismissed Qui Tam Case, Calls Whistleblower a “Serial Relator”

In November 2013 and this past October, Mintz Levin’s Health Care Qui Tam Update highlighted three separate qui tam False Claims Act (FCA) cases filed by Fox RX, Inc. (Fox), a former Medicare Part D plan sponsor. Fox filed...more

Seventh Circuit Holds Pharmacy Billing Medicaid For Drug Prices Above Private Rates Is Not Fraudulent

On November 12, 2014, the Seventh Circuit upheld the dismissal of a False Claims Act action challenging a retail pharmacy chain’s practice of billing Medicaid for the price differential between the higher Medicaid-negotiated...more

Vascular Solutions Inc. and its CEO Face Criminal Charges for Selling Unapproved Medical Devices

Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food...more

The Seventh Circuit Rejects Medicaid False Claims Act Suit

The United States Court of Appeals for the Seventh Circuit affirmed the dismissal of a False Claims Act (“FCA”) case against Shopko Operating Stores, LLC, in which a former Shopko pharmacist asserted Medicaid billing...more

White Collar Watch - October 2014

In This Issue: - Government demonstrates willingness to enforce Affordable Care Act provision that could cost providers millions of dollars - Words can come back to haunt you: Boilerplate pleading could lead...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

$840 Million Available to Drive Practice Transformation

After a fairly quiet year in terms of new funding announcements, the Center for Medicare and Medicaid Innovation (CMMI) has released an $840 million solicitation that seeks to drive 150,000 clinicians toward delivering...more

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more

New York Specialty Pharmacy Settles FCA Case

On October 9, 2014, New York’s Attorney General Eric T. Schneiderman announced an $846,000 settlement with New York specialty pharmacy Sorkin’s Ltd Rx. d/b/a CareMed Pharmaceutical Services (“Sorkins”) to resolve allegations...more

Third Circuit Tightens “Original Source” Requirement for Whistleblowers

Back in 2003 Karl Schumann filed a whistleblower suit alleging that as an executive with benefits company Medco, he learned that Bristol-Myers Squibb and AstraZeneca paid kickbacks to Medco to buy and recommend brand name...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act Cases: October 2014

Trends & Analysis - Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases...more

Federal and New York State False Claims Act Case Against Novartis Survives Motion to Dismiss

Last week, a New York district court found that the government alleged with sufficient detail that Novartis violated federal and state false claims acts by paying doctors kickbacks to prescribe drugs. See U.S. ex rel. Bilotta...more

Software Glitch Sparks FCA Suit Against Hospitals for Late Repayment of Medicaid Reimbursements

On June 27, the New York Attorney General’s Office and the U. S. Attorney’s Office for the Southern District of New York intervened in a qui tam suit against Continuum Health Partners, Inc., Beth Israel Medical Center and St....more

Medicaid Claims And Health Care Fraud: As The Data Flows, New Cracks Emerge

As we noted in two of our prior posts in the Insider blog, the government has long touted its ability to rely upon data mining as a means of detecting fraud in the federal health care system, and has initiated a host of...more

False Claims Act Litigation Update: Bayer Decision Sheds Light on Pleading in False Claims Act Cases

A recent win for a large company in a False Claims Act suit (a seeming rarity as of late) alleging illegal off-label promotion could provide some helpful insight to similarly situated manufacturers and support dismissals of...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed Cases

Trends & Analysis - ..We have identified 18 health care–related qui tam cases unsealed since last month’s Qui Tam Update. Of those, 10 were filed from 2012 to the present. The remaining cases, filed before 2012, date...more

Medical Research Fraud And HHS's Office Of Research Integrity: Watching The Watchdog

Even for those who carefully follow legal developments in the health care fraud arena, the Department of Health and Human Service’s Office of Research Integrity (“ORI”) is an agency that rarely appears on the radar. According...more

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