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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

DMEPOS Competitive Bidding Program: CMS Begins to Move Toward Nationwide Implementation and Seeks Public Comments Regarding...

The Centers for Medicare & Medicaid Services ("CMS") recently announced that the agency is seeking public comments as it moves toward nationwide implementation of the Medicare Durable Equipment, Prosthetics, Orthotics, and...more

Solicitor General Recognizes Conflict, but Recommends that Supreme Court Deny Review of False Claims Act Case Involving Rule 9(b)...

The United States Solicitor General has recommended that the Supreme Court deny certiorari in United States ex rel. Nathan v. Takeda Pharmaceuticals N.A. Inc., et al. (No. 12-1349), a False Claims Act (“FCA”) case involving...more

The Louisiana Supreme Court's Decision In Caldwell v. Janssen And The Broader Implications

On January 28, 2014, the Supreme Court of Louisiana set aside a judgment of $257 million in civil penalties that a lower court had entered in favor of the state against Janssen under the Louisiana Medicaid false claims act,...more

Eighth Circuit Addresses Scope of False Claims Act Liability

Last month, the Eighth Circuit Court of Appeals addressed the scope of “fraud-in-the-inducement” liability under the False Claims Act (FCA), 31 U.S.C. §§ 3729-3733, and, in doing so, reversed the dismissal of a claim related...more

NIH Declines to Exercise March-in Rights over Abbott Laboratories' Norvir®

Last week, the National Institutes of Health denied a petition from a coalition of "public interest" groups who petitioned the agency to exercise so-called "march-in rights" under provisions of the Bayh-Dole Act against...more

Eighth Circuit Adopts Novel False Claims Act Fraud-in-the-Inducement Theory Long Espoused by Government

On October 15, 2013, a divided three-judge panel of the United States Court of Appeals for the Eighth Circuit rendered a federal False Claims Act ("FCA") judgment against Bayer Healthcare Pharmaceuticals ("Bayer"), based on a...more

Second Circuit Affirms Dismissal of Qui Tam Case Based on Attorney’s Use of Confidential Information

The US Court of Appeals for the Second Circuit recently affirmed the decision of the District Court for the Southern District of New York to disqualify Fair Laboratory Practices Associates (FLPA) from its qui tam suit against...more

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

Trends and Analysis: ..We have identified 21 health care–related qui tam cases unsealed since last month’s Qui Tam Update. Of those, two were filed in 2013, 15 were filed in 2011 or 2012, and four were filed in 2010 or...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

McKesson settles with Virginia for $37 million over allegations of inflating Medicaid drug prices

After the State of Virginia declined to participate in a July 2012 settlement that McKesson reached with 29 states over allegations of federal and various state False Claims Act violations, the company has agreed to pay...more

Mintz Levin Health Care Qui Tam Update -- Recent Developments and Unsealed Cases: September 2013

Trends and Analysis - ..We have identified 24 health care-related qui tam cases unsealed since last month’s Qui Tam Update. Of those, only 2 were filed in 2013. Nearly half were filed before 2011. ..Among the 24...more

Will Usual and Customary Price be the Next False Claims Act Battleground?

Recently, a federal judge held that a qui tam relator’s allegations that a pharmacy routinely reported falsely inflated “usual and customary” prices for generic medications in claims submitted to federally funded health care...more

NEJM Perspective Calls for Recalibration of Bayh-Dole Act

In a perspective published in the August 29 issue of the New England Journal of Medicine, Dr. Howard Markel outlines the events leading up to the enactment of the Bayh-Dole Act and states that "a review of [the Act's] origins...more

Fifth Circuit Joins Chorus to Rein in False Claims Act

Add the Fifth Circuit to the list of jurisdictions questioning the use of the federal False Claims Act (FCA) in instances where – using the theory of implied certification - the alleged falsity is not apparent on the face of...more

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

Trends and Analysis: ..We have identified 20 health care-related qui tam cases unsealed in July 2013. About a quarter of those were filed in 2013. ..Among the cases unsealed in July, the government has declined to...more

Paying for Family Vacations With NIH Funds Triggers FCA Lawsuit and Settlement

Northwestern University will pay $2.93 million to settle a federal False Claims Act (FCA) lawsuit brought by a former employee who alleged Northwestern allowed a researcher to submit false claims under certain cancer research...more

"Health Care Enforcement Update: What Is in Store for the Next Five Years"

While predicting enforcement trends over the next five years is not without uncertainty, the best marker for future activity may be to look to the past. We believe that industry members and counsel can expect the Department...more

First Circuit Rules First-Filed Complaint Need Not Satisfy Rule 9(b) to Bar Subsequent Qui Tam Actions

To incentivize whistleblowers to bring false claims promptly to the government’s attention, the False Claims Act (FCA) includes a so-called “first-to-file rule“ (31 U.S.C § 3730(b)(5)), which bars a person other than the...more

Other Transactional Authority: A Nontraditional Tool for Partnering with the Federal Government

Last week, the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (“BARDA”) announced that it has used “other transactional authority” to enter into a novel, comprehensive...more

PODs Beware: OIG Releases Special Fraud Alert

The Office of the Inspector General (OIG) released a Special Fraud Alert on March 26, 2013 warning that physician-owned distributorships (PODs) are "inherently suspect" under the Anti-Kickback Statute (AKS). Generally...more

OIG Unveils Updated Self-Disclosure Protocol

In 1998, the Department of Health and Human Services' Office of Inspector General ("OIG") published the Self-Disclosure Protocol ("SDP"), which provides a mechanism through which health care providers may voluntarily report...more

White Collar Watch - April 2013

In This Issue: - Third Circuit Panel Liberalizes “Protected Activity” Immunity for Employees Claiming Whistleblower Status - Doing Time: A Requirement for White Collar Crime? - Casting a Smaller Net:...more

OIG Special Fraud Alert Labels Physician-Owned Distributorships (PODs) as “Inherently Suspect”

The U.S. Department of Health & Human Services, Office of Inspector General (the “OIG”) issued a Special Fraud Alert (“Alert”) on March 26, underscoring its heightened focus on fraud and abuse risks posed by physician-owned...more

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