Elsewhere, Shire`s CIA does not deviate from the few pharmaceutical transaction agreements. However, updates to Shire`s CIA parts seem to add to the fact that the OIG is trying to adapt to the CMS final rule. While the CIA covers the same definitions as the Sunshine Act, OIG still requires companies to communicate details on their site. For example, for each doctor, only the total total is needed. The company said it had not admitted any fault in connection with the agreement. In the agreements with GSK, J&J and Endo, HHS-OIG required these companies to establish lists of medical payments that can be consulted on their websites on a quarterly basis. Now this requirement is no longer applicable for the payment of general practitioners – Shire can only publish annually. However, as indicated in the next point, the OIG wishes to continue to make quarterly payments from “Independent Medical Education Activity Grants and Health Care Contributions”. The Shire Agreement entered into force on 15 September; See it here. The transaction, worth $US 2.5 million, includes US$550,000 recovered by former sales representative Heather Webb. Rakin`s comparison applies in addition to the $US 350 million paid by Shire and some subsidiaries in 2018, ACF`s biggest recovery to date related to medical devices. Rakin has not acknowledged any liability in connection with the transaction. The claims resolved by the transaction are only assertions and no liability provisions have been made.
Shires CIA has similar requirements and structures to previous agreements, with some notable changes, particularly in the category of disclosure of medical payments. We compared Shire`s CIA to the agreements of Endo Pharmaceuticals (21.02.2014), Johnson and Johnson (31.10.2013) and GlaxoSmithKline (28.06.2012). Now that all pharmaceutical and device manufacturers must comply with the Federal Sunshine Act, HHS-OIG appears to have changed its requirements for CIA companies based on Shire`s agreement. This comparison also resolves allegations that, between February 2007 and September 2010, Shire commercial agents made false and misleading statements about the effectiveness and abusive responsibility of their other attention deficit hyperactivity disorder (ADHD) drug Vyvanse with respect to Medicaid government form committees. . . .