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Big Pharma firm pays feds $350M to settle kickback claims case

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New Hampshire's Attorney General announced on Wednesday that New Hampshire, along with other states and the federal government, reached a settlement with Shire Pharmaceuticals LLC and other subsidiaries of Shire PLC (Shire).

The agreement settles allegations that Shire and the company it acquired in 2011, Advanced BioHealing (ABH), employed kickbacks and other unlawful methods to improperly promote Dermagraft, a bioengineered human skin substitute approved by the FDA for the treatment of diabetic foot ulcers.

Specifically, the agreement will resolve allegations that between Jan1, 2007, and Jan. 16, 2014, Dermagraft salespersons unlawfully provided clinics and physicians with lavish dinners, drinks, entertainment and travel; medical equipment and supplies; unwarranted payments for purported speaking engagements and bogus case studies; and cash, credits and rebates, to induce the use of Dermagraft.

In addition to the kickback allegations, the agreement resolves allegations that Shire and its predecessor (ABH) unlawfully marketed Dermagraft for uses not approved by the FDA, made false statements to inflate the price of Dermagraft, and caused improper coding, verification, or certification of Dermagraft claims and related services. Shire will pay the federal government $350 million dollars, of which $14.5 million will go to the Medicaid program, to resolve allegations that Shire's improper promotion and marketing of Dermagraft caused false claims to be submitted to government health care programs. As part of the settlement, New Hampshire will receive $13,571.56 in restitution and other recoveries for the Medicaid Program, AG Joseph Foster revealed in a press release. The claims resolved by the settlement are allegations only, and there has been no determination or admission of liability by Shire.

A team from the National Association of Medicaid Fraud Control Units conducted the settlement negotiations on behalf of the states.

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