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Pharma Fraud

This archive displays posts tagged as relevant to pharmaceutical fraud. You may also be interested in our pages:

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March 7, 2022

Pharmaceutical company Mallinckrodt ARD LLC will pay $260 million to resolve allegations that it violated the False Claims Act in the sale and marketing of its drug H.P. Acthar Gel.  The government intervened in whistleblower actions alleging that Mallinckrodt and its predecessor Questcor Pharmaceuticals Inc. knowingly underpaid state Medicaid programs by improperly calculating amounts it owed under the Medicaid Drug Rebate Program, and unlawfully used a foundation as a conduit to subsidize co-payments.  With respect to the Medicaid rebate claims, which represent $234.7 million of the settlement, defendants were alleged to have calculated rebate amounts as if Acthar was a “new drug” first marketed in 2013, rather than a drug that had been approved since 1952.  By using 2013 for Acthar’s Base Date Average Manufacturer Price (AMP), the company ignored price increases prior to 2013 and fraudulently reduced Acthar drug rebates.  With respect to the copayment fraud claims, which represent $26.3 million of the settlement, defendants were alleged to have violated the Anti-Kickback Statute by subsidizing copayments through payments to three funds that Mallinckrodt had a foundation set up to induce Medicare-reimbursed purchases of Acthar, using the subsidies to counteract doctor and patient concerns about the drug’s high cost.  The whistleblower in the Medicaid rebate case, James Landolt will receive an award of $24.7 million, representing 20% of the $123.6 million federal share of that settlement; the relator’s share for the state share of the settlement was not announced.  The whistleblowers in the copayment case, Charles Strunck and Lisa Pratta, will receive an award of $4.9 million, representing 19% of that settlement.  The settlement includes a five-year corporate integrity agreement (CIA) with monitoring provisions.  DOJ; USAO MA; USAO EDPA

January 28, 2022

Hayat Pharmacy agreed to pay over $2 Million to resolve allegations that it submitted false claims to Medicare and Medicaid for certain prescription medications from its 23 locations. The government alleged Hayat Pharmacy submitted false claims for two prescription medications, a topical cream consisting of iodoquinol, hydrocortisone, and aloe, and a multivitamin with the trade name Azesco.  Hayat Pharmacy allegedly switched Medicaid and Medicare patients from lower cost medications to the higher cost medications without any medical need and/or without a valid prescription. As part of the settlement, Hayat Pharmacy agreed to conduct annual training concerning waste, fraud and abuse, and compliance with rules concerning medication switches. USAO WI

Top Ten Healthcare Fraud Recoveries of 2021

Posted  01/11/22
doctor holding stethoscope
Consistent with the trend in prior years, the bulk of the Justice Department’s fraud and false claims recoveries in 2021 stemmed from healthcare fraud matters. Most of the funds recovered arose from cases originated by whistleblowers under the qui tam provisions of the False Claims Act. The majority of the recoveries on this list involve allegations of violations of the Anti-Kickback Statute, a federal law that...

Catch of the Week: Jury Finds Teva Pharmaceuticals Liable for Contributing to Opioid-Related Deaths in New York State

Posted  01/7/22
spilt pills
In a significant development in the ongoing effort to assess blame and responsibility for the opioid epidemic, which has led to the deaths of hundreds of thousands of individuals and ravaged communities throughout the United States, on December 30th, after a six-month trial, a New York jury found that Teva Pharmaceuticals USA, Inc. (“Teva”) and its affiliates, including Anda Inc., created a “public nuisance”...

Catch of the Week: Pharmacy Owner Convicted in $174 Million Telehealth Fraud That Targeted Consumers and PBMs

Posted  12/10/21
Pharmacists discussing medication
In yet another example of how unscrupulous providers can take advantage of the benefits of telehealth (or telemedicine) to commit healthcare fraud, on December 2, 2021, a federal jury in Tennessee convicted Peter Bolos, the owner and operator of Synergy Pharmacy, located in Florida, of 22 criminal counts, including violating the Food, Drug and Cosmetic Act (FDCA) by introducing a misbranded drug into interstate...

December 8, 2021

Pharmacist Riad “Ray” Zahr and two pharmacies he owned and operated, Plymouth Towne Care Pharmacy Inc. and Shaska Pharmacy LLC will pay $1 million to resolve a lawsuit initiated by a whistleblower alleging that the pharmacies submitted false claims for Evzio, a naloxone hydrochloride product used for the rapid reversal of an opioid overdose.  The government alleged that the claims included false and misleading prior authorization requests, including forged physician authorizations.  In addition, defendants dispensed Evzio without collecting or attempting to collect co-payments. DOJ; USAO MA

December 7, 2021

Vyera Pharmaceuticals, LLC and its parent company Phoenixus AG will pay up to $40 million and have agreed to make its drug Daraprim available to any potential generic competitor at list price to resolve claims of anticompetitive conduct.  The federal government and state governments alleged that Vyera principals Martin Shkreli and Kevin Mulleady enacted a plan to acquire life-saving toxoplasmosis drug, Daraprim, and dramatically raise its list price by 400% while engaging in conduct to prevent generic competition and protect their monopolistic pricing.  The resolution also bars Mulleady from working in the pharmaceutical industry for seven years; claims against Shkreli are continuing.  FTC; CA; NY; NC; VA

December 6, 2021

Pharmacy benefit manager Centene Corp. will pay $27.6 million to the State of Kansas to resolve allegations that it failed to satisfy its obligation to represent the state’s best interests in negotiations with companies that supply drugs to the state Medicaid program, failed to accurately report discounts it received from CVS-Caremark on certain retail pharmacy claims, and artificially inflated dispensing-fee amounts reported to state regulators.  The state alleged that Centene used an opaque reporting system that made it difficult for the state to determine the nature and appropriateness of certain pharmacy transactions.  As part of the settlement, Centene also agreed to change certain business practices to ensure greater transparency.  KS

Recent Settlements Show Kickbacks are Always a DOJ Enforcement Priority

Posted  11/15/21
Person Handing Hundred Dollar Bill to Another Person
The Department of Justice regularly highlights the areas of fraudulent conduct it intends to target as enforcement priorities.  These identified enforcement priorities tend to cover burgeoning areas of fraud or particular misbehavior especially ripe or prevalent because of the particular times we live in.  As might be expected, DOJ's current listing of priorities includes fraud related to the pandemic, opioids, the
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