Posted 18 August 2020 | By
The US Department of Justice (DOJ) on Tuesday announced it has filed a False Claims Act complaint against Teva Pharmaceuticals USA and Teva Neuroscience, alleging the company violated anti-kickback rules by coordinating with two patient assistance charities and a specialty pharmacy to cover Medicare co-pays for its multiple sclerosis drug Copaxone (glatiramer acetate).
“The government’s complaint today alleges that Teva used ostensibly independent charitable foundations as vehicles to pay hundreds of millions of dollars in kickbacks, all while raising the price of its drug, Copaxone, at a rate over 19 times the rate of inflation,” said Andrew Lelling, US attorney for the District of Massachusetts.
The complaint, filed in the US District Court for the District of Massachusetts, alleges that Teva referred Copaxone patients who would owe Medicare co-pays to specialty pharmacy Advanced Care Scripts and used data from the pharmacy and two patient assistance foundations, The Assistance Fund and Chronic Disease Fund, to determine how much the company would donate to cover the co-pays of patients receiving support from the foundations. The complaint also alleges that Teva coordinated with Advanced Care Scripts to refer newly prescribed Copaxone patients to the foundations, “which ensured that Copaxone patients received the vast majority of the co-pay assistance [The Assistance Fund] and [Chronic Disease Fund] provided with money from Teva.”
According to DOJ, Teva raised the price of Copaxone from $17,000 per year to $73,000 per year from 2007-2015.
The complaint comes less than a week after the US Attorney’s Office for the District of Massachusetts settled with Advanced Care Scripts to resolve allegations over its involvement with the co-pay assistance scheme. Last year, both of the foundations named in the complaint against Teva reached settlement agreements with the office for their involvement in kickback schemes.
The complaint is the latest in a series of anti-kickback actions involving patient assistance foundations brought by the Department of Justice against pharmaceutical companies in recent years. Last month, after Novartis Pharmaceuticals agreed to pay $51.25 million to resolve kickback allegations, the Department of Justice said it had collected more than $900 million from 10 drugmakers, United Therapeutics, Pfizer, Actelion, Jazz, Lundbeck, Alexion, Astellas, Amgen, Sanofi and Novartis, to resolve kickback complaints. (RELATED: Kickback allegation settlements pile up for pharmaceutical companies, Regulatory Focus 24 May 2018; Amgen, Astellas pay $125M to settle DOJ kickback allegations, Regulatory Focus 25 April 2019).
“The Anti-Kickback Statute prohibits pharmaceutical companies from offering or paying, directly or indirectly, any remuneration – which includes money or any other thing of value – to induce Medicare patients to purchase the companies’ drugs,” the department said.
“The government’s complaint today alleges that Teva used ostensibly independent charitable foundations as vehicles to pay hundreds of millions of dollars in kickbacks, all while raising the price of its drug, Copaxone, at a rate over 19 times the rate of inflation,” said Andrew Lelling, US attorney for the District of Massachusetts.
The complaint, filed in the US District Court for the District of Massachusetts, alleges that Teva referred Copaxone patients who would owe Medicare co-pays to specialty pharmacy Advanced Care Scripts and used data from the pharmacy and two patient assistance foundations, The Assistance Fund and Chronic Disease Fund, to determine how much the company would donate to cover the co-pays of patients receiving support from the foundations. The complaint also alleges that Teva coordinated with Advanced Care Scripts to refer newly prescribed Copaxone patients to the foundations, “which ensured that Copaxone patients received the vast majority of the co-pay assistance [The Assistance Fund] and [Chronic Disease Fund] provided with money from Teva.”
According to DOJ, Teva raised the price of Copaxone from $17,000 per year to $73,000 per year from 2007-2015.
The complaint comes less than a week after the US Attorney’s Office for the District of Massachusetts settled with Advanced Care Scripts to resolve allegations over its involvement with the co-pay assistance scheme. Last year, both of the foundations named in the complaint against Teva reached settlement agreements with the office for their involvement in kickback schemes.
The complaint is the latest in a series of anti-kickback actions involving patient assistance foundations brought by the Department of Justice against pharmaceutical companies in recent years. Last month, after Novartis Pharmaceuticals agreed to pay $51.25 million to resolve kickback allegations, the Department of Justice said it had collected more than $900 million from 10 drugmakers, United Therapeutics, Pfizer, Actelion, Jazz, Lundbeck, Alexion, Astellas, Amgen, Sanofi and Novartis, to resolve kickback complaints. (RELATED: Kickback allegation settlements pile up for pharmaceutical companies, Regulatory Focus 24 May 2018; Amgen, Astellas pay $125M to settle DOJ kickback allegations, Regulatory Focus 25 April 2019).
“The Anti-Kickback Statute prohibits pharmaceutical companies from offering or paying, directly or indirectly, any remuneration – which includes money or any other thing of value – to induce Medicare patients to purchase the companies’ drugs,” the department said.
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US sues Teva over Copaxone co-pay assistance scheme - Regulatory Focus
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