Question of the Day May 2, 2015 In a recent press release, Manhattan U.S. Attorney Preet Bharara said: “This is the second substantial settlement with an alleged co-conspirator of Novartis in connection with a scheme that used the lure of kickbacks to co-opt a healthcare provider’s independence. As alleged in our intervention papers, Novartis used Accredo to promote refills under the guise of purported ‘counseling’ and ‘education,’ and in doing so, Novartis caused patients to receive one-sided advice that did not discuss Exjade’s serious, potentially life-threatening, side effects. This settlement with Accredo restores to the public fisc tens of millions of dollars paid out for kickback-tainted drugs.” Are some compounding pharmacies violating kickback laws with their counseling and education programs?

Here are more of the allegations:  As alleged in the Government’s second amended Complaint and in the relator’s third amended Complaint, NOVARTIS markets and manufactures Exjade, an iron chelation drug approved for use by patients who have iron overload resulting from blood transfusions. For approximately five years until 2012, NOVARTIS orchestrated a scheme whereby it offered kickbacks, in the form of patient referrals and other benefits to certain specialty pharmacies, including ACCREDO and Bioscrip, in exchange for increasing their Exjade refills through biased recommendations to patients. ACCREDO and Bioscrip were part of a NOVARTIS-created exclusive distribution network for Exjade called the Exjade Patient Assistance and Support Services (“EPASS”), and through this network NOVARTIS was able to refer Exjade patients to particular pharmacies within the network.

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