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The Department of Justice (DOJ) recently released its annual statistical report on recoveries and new matters under the False Claims Act (FCA). The aggregate reported recovery of $2.8 billion for fiscal year (FY) 2018 is the lowest such total since FY 2009 and is 17% lower than last year’s total and less than half of FY 2014’s all-time high recovery of over $6.1 billion. As the table below shows, however, DOJ’s and private qui tam…
Part D Plan Sponsors’ Access to Medicare Parts A and B Claims Data Extracts As detailed in previous posts in this series, one major objective that the Centers for Medicare and Medicaid Services (“CMS”) addressed in a proposed rule issued November 1, 2018 (the “Proposed Rule”), was to implement new Social Security Act provisions that Congress added in the Bipartisan Budget Act of 2018 (“BBA”). One such provision will open fee-for-service Medicare data up to…
When commercially available medications’ standard dosage forms or amounts don’t quite fit a patient’s particular needs, the patient may benefit from customized compounded drugs. Medicare Part D, the prescription drug program, allows the private company sponsors that administer the benefit to cover compounded drugs under certain circumstances.[1] In recent years, Part D reimbursement to pharmacies for compounded drugs has increased significantly. A 2016 report by the Office of the Inspector General for the Department…
As described in an April 17, 2018 article originally posted on the Sheppard Mullin Richter and Hampton, LLP False Claims Act Defense Blog, Kmart Corporation and the U.S. Department of Justice entered into a False Claims Act settlement agreement dated March 8, 2018, to end an investigation that was conducted jointly by the United States Attorney’s Office for the Eastern District of California and California’s Bureau of Medicaid Fraud and Elder Abuse. In a March
On Thursday, March 8, Kmart Corporation inked a settlement of a False Claims Act investigation[1] in which the qui tam relator initially alleged systematic pharmacy billing fraud across twenty-seven states for $525,000.[2] Brought by a pharmacist formerly employed at a Kmart in Lakeport, California, the original complaint alleged among other things that, instead of using a state-made drug utilization review alert system, Kmart relied on its own electronic systems that were not sufficiently…
In a move sure to cause murmurs in the large and growing mobile health application industry, the Office of New York Attorney General Eric Schneiderman (OAG) has used state trade laws to extract concessions and monetary penalties from mHealth app developers, including the developer of a supposed fetal heart monitoring smartphone app.…
Statistical sampling is always a hot topic in False Claims Act (FCA) litigation.  Courts have allowed statistical extrapolation from samples of claims to determine damages in cases where FCA liability was already established.[1]  But courts are reluctant to allow the use of sampling for determining liability in the first instance.[2]  Since the FCA’s monetary penalty per “violation” has been held to apply to each individual claim submitted for reimbursement, it seems…