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Pharma Fraud

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November 3, 2022

Teva Pharmaceuticals, Ltd., subsidiary Teva Pharmaceuticals USA, and its affiliates will pay $523 million to New York State for their role in fueling the opioid crisis. Injunctive relief includes a ban on high-dose opioids and prescription savings programs, prohibitions on marketing and funding third parties that promote opioids, restrictions on political lobbying, and monitoring and reporting of off-label use of fentanyl nasal spray products. NYAG

October 12, 2022

Four pharmacies have agreed to pay over $6.8 million to settle a qui tam suit that alleged they defrauded TRICARE and the Federal Employees Health Benefits Program, in violation of the False Claims Act.  According to a former accountant for one of the pharmacies, DermaTran Health Solutions, LLC; Pharmacy Insurance Administrators, LLC; Legends Pharmacy; TriadRx; and Lake Side Pharmacy created a program to waive mandatory copays for beneficiaries of federal health insurers, overcharged the government for compounded pain creams, and traded out-of-network prescriptions with other pharmacies, which constituted a kickback.  USAO NDGA

September 26, 2022

Biogen Inc. has agreed to pay $900 million to resolve allegations by former employee Michael Bawduniak that the pharmaceutical company paid illegal kickbacks to physicians in order to induce prescriptions of their multiple sclerosis drugs, causing false claims to be submitted to Medicare and Medicaid.  According to Bawduniak, over a five-year period, Biogen paid kickbacks in the form of speaker honoraria, training fees, consulting fees, and free meals.  The vast majority of the settlement proceeds (over $840 million) will go to the federal government, while the remainder will be divided among 15 states.  USAO MA

September 14, 2022

Illinois-based pharmaceutical company Akorn Operating Company LLC has agreed to pay $7.9 million to resolve allegations of violating the False Claims Act by causing Medicare to pay for three generic drugs that stopped being eligible for coverage when their original manufacturers converted the brand name drugs from prescription only to over-the-counter.  According to a whistleblower, the brand name drugs in question were converted in February 2020 and June 2021, but Akorn knowingly failed to seek conversion of their generics until a year later because it knew over-the-counter drugs were non-reimbursable.  USAO MA

September 2, 2022

Bayer Corporation, together with its subsidiaries, will pay $40 million to settle claims initiated by a whistleblower alleging that the pharmaceutical manufacturer violated the False Claims Act by engaging in off-label marketing, unlawful kickbacks, and misreporting of safety risks with respect to its drugs Trasylol, Avelox, and Baycol.  The whistleblower, former Bayer marketing employee Laurie Simpson, will receive approximately $11 million from the settlement.  DOJ; USAO MN; USAO NJ

August 24, 2022

Centene will pay Washington State $19 million to resolve allegations that the company overcharged the state for pharmacy benefit management services.  The state alleged that Centene failed to pass on discounts it received to the state Medicaid program, and inflated dispensing fees.  WA

August 11, 2022

Spivack, Inc., formerly operating as Verree Pharmacy, and owner-pharmacist Mitchell Spivack, have agreed to pay over $4.1 million in civil penalties for dispensing opioids despite numerous red flags the drugs were being diverted—all in violation of the False Claims Act and the Controlled Substances Act. In furtherance of the fraud, Spivack made false statements to drug distributors to maintain the façade of legitimacy, while concurrently drawing millions from the pharmacy and harming the public. In addition to their opioid fraud, Spivack and Verree effectuated their “Bill But Don’t Fill” scheme, where they would enter “BBDF” in their internal computer system, and would submit false claims to insurers for drugs not actually dispensed. USAO EDPA

August 3, 2022

Dunn Meadow LLC dba Dunn Meadow Pharmacy, pleaded guilty to illegally distributing prescription fentanyl and paying kickbacks to healthcare providers, in violation of the False Claims Act and the Controlled Substances Act. From 2015 through 2019, Dunn Meadow filled prescriptions not written for a legitimate medical purpose, including those for patients exhibiting suspicious drug-seeking behavior (i.e., requesting prescriptions be sent to suspicious or inappropriate locations including hotels, casinos, and elementary schools). These actions caused a $4.5 million loss to the federal government. Dunn Meadow will pay up to $50 million over the next five years to resolve its civil liability if it generates future revenue. USAO NJ

July 29, 2022

Allergan will pay up to $2.27 billion to settle allegations they deceptively marketed opioids by downplaying the risks of opioid addiction and instead touting exaggerated benefits from the drugs. Rather than encouraging alternative treatments, Allergan encouraged doctors to prescribe more opioids, and failed to maintain effective controls to prevent diversion of opioids. This settlement involves multiple states, excluding New York, which settled separately with Allergan. VA OAG

July 26, 2022

Mallinckrodt ARD, LLC f/k/a Questcor Pharmaceuticals, Inc. will pay over $233 million over a 7-year period to settle False Claims Act violations, which occurred from January 2013 through June 2020. During this time, Mallinckrodt knowingly underpaid Medicaid rebates on its H.P. Acthar Gel. The practice was exposed by a whistleblower lawsuit originally filed in Massachusetts. Mallinckrodt paid rebates for Achtar in 2013 as if it was a “new drug” rather than one that was introduced to the market in 1952. NJ OAG
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