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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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